Deputy Secretary of the Export Administration. (2023)

Section 312 of the law on the management of coastal zones obliges the NOAA to carry out regular ratings of state coastal programs that were approved by the Federal Government and the National Demolization Reserves.The process includes one or more public sessions, taking into account public comments and consultations with interested state and public authorities and public members.For the evaluation of the Indian Lake Coastal Management program, NOAA will consider to which the state has followed national goals, the management program approved by the Minister of Commerce and fulfilled the conditions of financial support as part of the management of management.When the evaluation is completeFederal registrationAnnouncement of the availability of the final evaluation results.

The petents of this investigation are Instal Industries Inc., Mid-Shut Wire Company, National Wire LLC, Oklahoma Steel & Wire Co. und Wrahtnetzkorp. (Together, The Petents).In addition to the government of Mexico, the mandatory respondents are aceromex s.a.von c.v.(Aceromex) and deepero s.a.p.i.de C.v.(Deecero).

A summary of events published since tradePreliminary provision, 1 In addition to a complete discussion about the topics raised by the parties for this final decision, they are discussed in problems and the decision that are taken over by this notification.2 Problems and decision memorandum are a public document and in the file electronically through use and anti -dumping and duty to compensate for central complianceElectronic Service System (access).Access is available in registered usershttp://access.trade.gov.In addition, a full version of the problems and decision Memorandum can be accessed directlyhttp://enforcement.trade.gov/frn/.Signed and electronic versions of problems and decisions -the manufacture of content is identical.

The examination period will take place from January 1, 2019 to December 31, 2019.

The scope of the examination is Mexico's wire network.For a complete description of the scope of this investigation,AhaAnhang I.

Subventions that examined and questions in the case and resistance of the parties of this investigation are contained as Appendix II.

Commerce carried out this investigation in accordance with Section 701 of the 1930 tariff law in the changed version (the law).For each of the subsidy programs found, trade finds that there is a subsidy.Dh,,A financial contribution to a "authority" that brings the recipient a benefit and that the subsidy is specific.3 For a complete description of the methodology, which is based on our final provision,AhaThe problems and the decision memo.

With this final determination, which is based on trade, partly based on facts that are available in accordance with Section 776 (A) of the Act.Answer our information inquiries, we may draw negative conclusions when choosing the available facts.In the other way, 776 (b) of the law reacted.The interviewed Deecero did not respond to the questionnaire (DCV) of trade for the first remuneration service, and we continue to use subsidy rates for these companies in accordance with Section 776 (D) of ThES.AhaThe section "Use of available facts and negative conclusions" in the associated problems and the decision memo.

The trade was unable to check the information center based on the final determination in this study.However, we take additional measures instead of a location test to check the information on the basis of this final determination in accordance with Section 782 (I).4

Based on our review and analysis of the information instead of checking the site, we have made certain changes to the subsidy installment calculations for aceromex.As a result of these changes, the trade has also revised the rate of everyone else.For a discussion about discussion these changes,AhaThe problems and the decision memo.5

In accordance with section 705 (C) (1) (b) (i) (i) of the law, we calculate a subsidy rate that is not available for aceromex.a.i) It is right that we correspond to all the other other for all exporters and manufacturers who have not been examined individually, a rate of all others that the compensable assignment rates of the weighted average for E -Producer exporters who have been examined individuallyde minimisCompensable subsidies and interest rates that are completely determined in accordance with Section 776 of the Law.

In this study, Commerce attributed a fully based interest rate to available facts,Dh,,in accordance with § 776 of the law for deepero.Through minimis,Or is based exclusively on facts that are otherwise available, the calculated rate for aceromex.As a result, the calculated rate for aceromex is also returned as the rate for all other manufacturers and exporters.

The trade states that there are the following estimated rates of Semi -vite subsidies:

Commerce intends to disclose the calculations carried out in connection with this final provision within five days from the date of publishing this notification to the parties in this process in accordance with 19 CFR 351.224 (B).

As a result of ourPreliminary provisionand in accordance with sections 703 (d) (1) (b) and (d) (2) of the law, trade indicated in subjects and CBP test subjects (US border protection (US border protection), as described in the examination area orIt was withdrawn from the warehouse for consumption in or after the date of the publication of the publication of thePreliminary provisionnoFederal registration.

If the US International Commission of Commerce (ITC) issues a final determination of a positive injury, we will issue a CVD arrangement and request an estimated remuneration cash deposit for these inputs in the above values.If ITC determines this material, violations or threats from material injuries do not exist, this procedure is closed and all estimated tasks or securities that are published as a result of the suspension of the agreement will be reimbursed or canceled.

According to Section 705 (D) of the law, we will inform ITC about our determination.In addition, we provide ITC all the unrivaled and non -proprietary information.We will provide ITC access to all privileged information and business owners in our archives, provided ITC confirms that this information is not publicly or in accordance with an order of the administrative protection (APO) without the written consent of the deputy secretary for applying and compliance with the deputy secretary.

Since the final provision in this process is affirmed, ITC is concluded in accordance with Section 705 (B) of the law whether the domestic industry in the USA is significantly violated or threatened with material injuries.Days after our final provision.If ITC determines the CBP for evaluation by trading through trade, the tasks for all imports of the goods concerned, which are inserted or removed from the warehouse, compensate for the consumption after or after a date of suspension of the processing, as above inSection explained."Continuation of the setting of the setting".

If the ITC has issued a final determination of a negative injury, this warning will serve the only memory of the parties that are subject to the responsibility for the destruction of owner information, which were disclosed in accordance with APO according to APO 351.305 (3) (3)3) (3) The timely written notification of the return/destruction of support materials or the conversion into the order of legal protection is requested.The non -compliance with the regulations and conditions of an APO is a violation that is subject to a sanction.

This statement is published and published in accordance with Sections 705 (D) and 777 (i) of the law.

The following species are treated in this warning:

PUGET SOUND Chinook salmon (Oncorhynchus thawytscha): Threatened, naturally produced and artificially propagated;

Puget Sound Steelhead (O. MYKISS): PUGET Sound threatened, produced and artificially propagated;

PUGET Sound Chum Salmon (O. KETA): Threatened, naturally produced and artificially propagated;

Lachs Chinook River Snake River (O. Tshawytscha): Threatened, naturally produced and artificially propagated;

Snake River Steelhead (O. MYKISS): Threatened, naturally produced and artificially propagated;

Sockeye River River Snake Lachs (Ö.): Threatened, naturally produced and artificially propagated;

Lower Columbia River Chinook Salmon (O. Tshawytscha): Threatened, natural and artificially propagated;

Lower Columbia River Coho Lachs (Oh.beije tch): Threatened, naturally produced and artificially propagated;

Lower Columbia River Steelhead (O. MYKISS): Threatened, natural and artificially propagated;and

Lower Columbia River Chum Lachs (O. KETA): Threatened, natural and artificially propagated.

Duwamish-Green:The 10 joint plans for programs that are located in this pool are Prey Base for endangered Maubauze whales (SRKW).Set aircraft also offer autumn salmon for harvesting.

Stillaguamic:The four common plans for programs that are located in this poolUnited States of Americav.Washingtonand contract rights.Chinook sets match the Stillaguami Chinook (Sirc) Sallook (Sirc] (Sirc] (Sirc] (Sirc] (Sirc) Salvary Salme Salme Plans (Sirc) PUGET SOUND 2007).

Yankee-Panther:The two joint plans of the Shoshone/Bannock trunks try to restore the catch opportunities for tribal members through Chinook -Lach -Lach -In -Incubatorial programs in Yankee forking areas and Panther Creek.-Term sustainability of Chinook salmon in the upper salmon River basin.

Echoman:Washington's Department of Fish and Wildlife suggests restoring a COO program for late return in the ÖROCH -Roman pelvis.The program aims to reduce the effects on the production of incubators into the Coho of Lower Columbia River listed at the ESA and to integrate the origin -coho into the preserving program.The program of the Grays River Coho Coho Coho breeding egg has made itself available in the program of tribal, sports and commercial opportunities as part of the Grays River River Brieferei program, and the production of the program has changed to Beaver Creeks Hatter.

All submitted HGMPs agree with each of the species recreation plans listed in the ESA and are intended to help save their populations in significant evolutionary units (ESU) and / or different population segment interval (DPS).From their assessment, they were firmly developed and operated to ensure that the effects on the effects on the Chinook salmon of natural origin are not significantly reduced by ESA, COO salmon, Chum salmon and silver trout populations.Science available to reduce adverse genetic effects and reduce competitive and predator effects that are usually associated with salmon and silver trout programs.Surveillance and evaluation are implemented in order to evaluate the performance of each program in the achievement of the conservation goals of the population or the population or the population or the evaluation of harvesting and their effects on the natural salmon from Chinook, which in Esa, salmon, salmonand silver trout are listed.Information received by monitoring and evaluation.

A review of NMFS and CO administrative monitoring and evaluation results will occur annually in view of the performance standards, which was determined by the HGMPS relateness and the inclusion of new information from research, provides the monitoring and evaluation of HGMPsNMFS The information required to determine which performance standards have been attended.

Duwamish-Green:NMFS published a notification of the proposed evaluation and pending provision (PEPD) on the common public review plans and comments on April 2, 2019 (84 FR 12593), as required according to the rule of Section 4 (D) of ESA.A PEPD 30Available for public reviews and a comment for days.

Stillaguamic:NMFS published a warning of his environmental assessment project (EA) and PEPD on the proposed joint plans for public review and comments on June 28, 2019 (84 FR 31031), as according to the rule of ESA 4 (D).EA and PEPD are prescribed for the public review and comments for 30 days.

Yankee-Panther:NMFS published a warning from his EA and PEPD on the common public review plans and comments on March 10, 2020 (85 Fri 13876), as according to the rule of ESA 4 (D).Comments for 30 days.NMFS received no comments.With the base on our earth, NMFS has published its final statement on Yankee Fork and Panther Creek HGMPS.

Elochoman/Beaver Creek:NMFS published a warning of HGMP for public review and comment on October 4, 2019 (84 FR 53104), as required in the ESA section 4 (D) Rule.

Say that:The availability of Feis availability was published in theFederal registrationOn July 12, 2019 (84 FR 33256).4 (D).The 10 salmon and trout trout programs silver in the Duwamish Green River basin would be implemented as described in the specified plans.For the decision, the alternative is viewed, which is preferable as environmental compatibility, and identified and discussed relevant factors that are compensated for and are discussed by balanced factors.NMFS in his decision.

Stillaguamic:NMFS decided to choose the selected alternative to choose the selected alternative from EA Final.The NMFS found the pelvis implemented as described in the specified plans.Fonsi documents the decision that proposed common plans will probably not significantly influence the human environment.

Yankee-Panther Creek:NMFS has decided to select the agency's most popular alternative in EA, alternative 2. Selected alternative The river basin would be implemented as in the specified plans.Fonsi documents NMFS decision that proposed common plans will probably not significantly influence the human environment.

Elochoman/Beaver Creek:The NMFS found that the HGMP sent by Washington Wildlife and Wildlife Department (WDFW) met the limit 5 requirements of the ESA 4 (D) rule.).The additional information report (SIR) deals with the environment and evaluates new information that has been available since analyzing the existing NEA.The incubation program of the Elochoman River Basin would be implemented as described in the HGMP sent.

16 U.S.C.1531-1543;Sub-section B, § 223.201-202 also published under 16 U.S.C.1361and Segs.;16 U.S.C.5503 (d) Abs. § 223.206 (d) (9).

The Gulf of Mexico, the South Atlantic and the Caribbean fishing control councils as well as the NOAA fishing as well as the Atlantic and Golf Marine Fischerei commission have implemented the Southeast data, the evaluation and the review process (Sedar), a method of determining several steps to determine the fish stocksOstatus in the southeast.Sentences and recommendations which data records are suitable for the evaluation analysis.Evaluation -Webinars create a report that describes fishing, evaluates the status of the measures, appreciates biological benchmarks, future population conditions and recommends research and surveillance needs.Review of the workshop products is a summary of the summary of the assessment, the opinions of the strengths of the strengths of strengths documented and data assessment and entry data of the weak data.Participants in Sedar workshops are appointed by the Golf of Mexico, the South Atlantic and in Caribbean fishing management and in the Southeast Regional Office of NOAA in the Management Division HMS and Southeast Fisheries Science Center.Add data collectors and database managers, scientists, biologists and researchers of action development as well as representatives of the electoral district, including Fischer, Environmentalists and NGOs;International experts and consulting staff;state and federal commissions and agencies.

Discussion elements during the evaluation webinar are as follows:

• Using data records and recommended first evaluation analysis in data webinars will use Panel participants evaluation models to evaluate the inventory status, to appreciate population benchmarks and management criteria and to project future conditions.

• The participants recommend the most suitable methods and settings to determine the inventory status and estimate the population parameters.

Although there are no notes of notes contained in this agenda in front of this group for discussion, these questions may not be the subject of formal measures during this meeting.The measures are limited to these questions specifically identified in this communication and all the publication of this communication, which is based on the devoted problems, in which emergency measures in accordance with Section 305 (c) of the law on the preservation of the catch and the management of Magnuson seans are necessary, provided thatPublic was intended to take the final measures for dealing with emergency.

The meeting is physically accessible for people with disabilitiesMatters) At least 5 working days before each webinar.

On December 11, 2019, trade began with the administrative review of the Order of Anti -Dumping Service in 1930 in the changed (the law).1 This review covers a producer/exporter of the goods in question, the Hyundai Steel Company (Hyundai).On April 24, 2020, the trade held its criterion to raise all deadlines for administrative revisions within 50 days, which led to a revised period for these preliminary results.2 On July 21, 2020, trade covered all deadlines in administrative revisions for another 60 days.3 In addition, the trade practiced its discretion to extend the deadline for preliminary results by February 17, 2021.4

The products that are covered by thiscommand 5 are certain steel products with a flat and hot roll roll.For a complete description of the scope,AhaThe memo of the preliminary decision.6

The trade carries out this review in accordance with Section 751 (a) of the law.The export price and the built export price are calculated in accordance with section 772 of the law.The normal value is calculated in accordance with section 773 of the law.

For a complete description of the methodology, which is based on these preliminary results,AhaThe memo for preliminary decision.Preliminary decision -making memorandum is a public document and is made available to the public via the electronic central anti -dumping and duty duty (Access) Electronic Service system.Access is available in registered users in registered users.https://access.trade.gov.In addition, a full version of the provisional decision Memorandum is available inhttp://enforcement.trade.gov/frn/.A list of topics contained in the provisional decision memorandum is included as an appendix to this warning.

We initiate that from October 1, 2018 to September 30, 2019 there is the following average dumping margin for the period:

We intend to publish the calculations within five days of the public announcement of the provisional results.7 According to 19 CFR 351.309 (C), the stakeholders can send cases to delay 30 days after the publication of this warning.The opposition summaries that have been raised in the prime loads of the case on the date in order to submit case summary.8 The trade has changed some of its requirements to meet documents, to notice the business owners.9 The parties that send summaries or resistance summaries in this process are encouraged to send to every argument: (1) an explanation of the question;(2) a brief summary of the argument;and (3) a table of the authorities.10 The summaries of the case and refutation must be archived using Access11 and must be applied to stakeholders.12 The summaries of the executive must be limited to a total of five pages, including footnotes.

According to 19 CFR 351,310 (C), stakeholders who want to request A areThe hearing must send a written application to the deputy secretary for execution and conformity, which is submitted electronically by Access.Inquiries must contain the following: (1) Name, address and telephone number of the party;(2) the number of participants;and (3 3);) A list of questions that should be discussed.Questions that were raised during the hearing will be limited to the summaries summarized in the respective case.A request for an electronically archived hearing must successfully access the Electronic Record System trade at 5:00 p.m.Oriental hours within 30 days after the publication of this message.

Commerce aims to provide the final results of this administrative review, including the results of the analysis of the questions raised in a written summary, later 120 days after the date of publication of this notification in accordance with Section 751 (3) (3) (3) (3) (3) (3) (a) of the law and 19 CFR 351.213 (H) (1).

After completing the final results, the trade and customs and US -American border protection (CBP) evaluates anti -dumping tasks at all suitable entries.de minimisIn the final results of this review, we calculate a specific importance rate based on the total number of dumping, which is calculated for sales, which was examined by each importer, and the total amount that was inserted from the same sales in accordance with 19 CFR 351.212 (b)1) .13 If the Hyundai -weighted average margin or an importer -specific evaluation rate is zero orde minimisIn the final results of the review, we will instruct the CBP to pay the corresponding entries without taking into account anti -dump tasks.14 The final results of this administrative review should be the basis for the evaluation of anti -dumping tasks for the entries of goods that are covered under the final results of this review and for future tasks of valued tasks.fifteen

For the raw material entries in question during the pig intermediate company (s) produced by Hyundai, which are involved in the transaction.16

Commerce intends to provide evaluation instructions for the CBP at the beginning of 35 days after the date of publishing the final results of this review in the issueFederal registrationWenn beim US International Court of Commerce ein günstiger Anruf vorgelegt wird, lenken die Bewertungsanweisungen die CBP, relevante Einträge erst zu begleichen, bis die Parteien einen Antrag von einer gesetzlichen Verfügung abgelaufen sind (abgelaufen sind (abgelaufen)Dh,,within 90 days of publication).

The following requirements for cash payment will come into force after the publication in the entry into forceFederal registrationFrom the administrative revision of the final revision of all core laminate steel transfers or the withdrawal from the warehouse, for consumption on the date or after the publication date, as stated in Section 751 (a) (2) (c) DEACash payment rate for Hyundai corresponds to the deposit of the weighted average, which was determined in the final results of this administrative review;(2) For goods that were exported by a company that did not address in this review, but in addressed an earlier segment of the process, the cash deposit rate is further an investigation, but the manufacturer is the cash payment rate of the course in the completed segment for the lastPeriod for the goods producer (4) The cash payment rate for all other manufacturers or exporterdies will continue to be 6.05 %, the rate of everyone else in the investigation less than fair.17 These cash payment requirements remain in force when they are imposed, until I have warned the most.

This warning also serves as a preliminary memory of importers in the responsibility under 19 CFR 351.402 (2) to register a certificate about the reimbursement of anti -dumping tasks.Anti -dumping tasks occurred.

We result in these results in accordance with sections 751 (a) (1) and 777 (i) (1) of the law and 19 CFR 351.221.

These meetings are available to the publicAbout the web link above.If you only enter the phone, call calls that start after wireless lines, and the Commission will not reimburse the Federal Relay Service from number 1-800-877-8339 and the service of the conference, which by registering the aboveWeb links is given.To request additional accommodations, send an emailmtrachenberg@usccr.govAt least 7 days before the meeting, for which accommodations are requested.

Public members are entitled to comments during the open time of the meeting.Public members can also send written comments;Comments must be taken in the regional programs within 30 days of the meeting.mtrachenberg@usccr.gov.People who want additional information can contact the Regional Programs Unit at (202) 809-9618.Registration and documents that are discussed during the meetingwww.facadatabase.gov.People who are interested in the work of this advisory committee are recommended to go to the Commission's website.www.usccr.gov,Or contact the regional programs units under the number of telephone or e -mail address mentioned above.

This meeting is available to the public via the following free number: 800-367-2403, Conference Dimination number: 6603878. Every public interested can call this number and hear the meeting.Wireless lines and the commission will not provide any information.Number 1-800-877-8339 and provision of the service number and the conference zealous number.

Public members are entitled to comment during the period at the end of the meeting.Public members can also send written comments;Comments must be received in the regional program department within 30 days of the meeting.Rights Commission, 300 North Los Angeles Street, Suite 2010, Los Angeles, CA 90012 or Amumay Ana Victoria Fortes emaxortes@usccr.gov.

Records and documents that are discussed during the meetinghttps://www.facadatabase.gov/FACA/FACAPublicViewCommitteeDetails?id=a10t0000001gzlyAAA.

The records created at this meeting can also be inspected and reproduced in the regional programs units because they are available before and after the meeting.People who are interested in the work of this committee are directed to the Commission's website.http://www.usccr.gov,Or you can contact the Regional Programs Unit under e -rope or street address above.

Fort Benning plays a crucial role in supporting the comprehensive mission of the army.As an army MCO, the home of the army arms and infantry schools, Fort Benning has to support the institutional training of soldiers and infantry and armaments.Opportunity to react to a wide range of situations that you can expect on the modern battlefield.Security force, Infantry-Task Force 1-28 and the elements of the 75th Ranger Regiment.

Fort Benning should be able to train and develop highly qualified and coherent units that are able to carry out operations throughout possible conflicts throughout the spectrum.The Good Hope Manövring Training Area (GHMTA) maneuver maneuvers of sufficiently heavy street maneuvers.The strategy of army training has changed from GHMTA in "Movement and maneuvers between the domains", which requires an additional coherent area for a strong off-road maneuver.

The final ice analyzes the possible environmental and socio-economic effects associated with the proposed action, including direct, indirect and cumulative effects.Disadvantaged effects of reduction through environmentally friendly prevention and design, such as:Maximum practical expansion.This is the final detection of additional reduction measures that the army can carry out in order to further reduce the identified adverse effects.

The army concluded the consultation for this action in accordance with Section 7 of the Threatened Species Act, and this is included in ice.

The army identified three appropriate action alternatives that would achieve the goal and the need for the proposed action;These three alternatives of action (Dh,,Three different locations in Fort Benning, where a Homma could be built) are analyzed in detail in the final.

1.Alternative 1 (preferred alternative): Training area of maneuvers that are assembled in the northern alternative:This alternative comprises approximately 4,724 ACRs and is located next to and east of the current northern and western maneuvers as well as near the digital complex for Fort Benning (DMPRC).

Alternative 1 would offer the most preferred size and configuration of the shape alternatives to enable high-quality off-road heavy maneuvre training.

2.Alternativa 2: Red Diamond Alternative:This alternative comprises approximately 3,744 tomorrow and is located south of the southern maneuver representative area (SMTA) near the southern border of the installation.

3.Alternative 3: Oriental border Alternative:This alternative comprises approximately 2,405 ACRES and is located between the Northern Duzada Impact Area and the eastern border of the installation.

The army directed the alternative without measures for detailed analysis in the final.Although the alternative without action did not achieve the goal and the need for the proposed action, this alternative was retained in order to provide a comparative basic line against which the effects of analyzed action alternatives, as required by the Council for the NEPA regulation of environmental quality.

The resource areas analyzed in the final include:Land use (relaxation), air quality, noise, floors and topography, water resources (including damp zones and flood areas), biological resources, cultural resources, socio -economics, infrastructure as well as dangerous and toxic waste and waste.

Based on the analysis presented in the ice -ended analysis, potentially significant adverse effects on biological resources can occur (biological resources (Dh,,Disorder of unique ecological areas).Effects on all other resource areas would be less than significant (Dh,,insignificant, smaller or moderate) disadvantage or advantageous.Practical reduction measures are finally presented to reduce possible adverse effects.

All shape alternatives for the proposed campaign can adverse the wetlands and/or flood areas of 100 years.As a result, the army also prepared a Fonp to comply with the executive regulation (E.O.) 11988,Flutebene Management,and E.O.11990,Protection of wet areas.As in the final environmental protection measures (described) (FOR EXAMPLE,Strong maneuvering training -buffers) and regulatory conformity measures (measures to comply with regulations (FOR EXAMPLE,Allow CWA sections 401 and 404 would be implemented to minimize adverse effects on these resources.

Between May 29 and July 13, 2020, the army carried out a public review and comment period for the EIS draft, including a public conference on the telephone conference on June 30, 2020. The army tested and worked on the final ice comments that duringthis commentary period had been received by the EIS project.

Printed copies of the ice cream and the final fonpa are made available for 30 days in the Columbus public library, the public library of Cusseta-Schattaochee, the Milton E. Long Library and the Phenix City-Russell County Library in public for 30 days,,If the libraries Foremberto for public visits when this NOA is publishedhttps://www.benning.army.mil.

When publishing this final NAA, the army will prepare and publish its ROD, in which the alternative is announced, which is environmentally treated, which alternative for implementation (either a shape alternative or alternative without measures) and this reduction in tenants to reduce possible side effects.The publication is selected.The rod is published before 30Days after the publication of this final NAA.

Doe publishes Hussmann's petition on full resignation in the appendix of this document in accordance with 10 CFR 431.401 (B) (1) (IV).1 Doe invites all stakeholders to write until March 22, 2021, comments and information on all aspects of the petition, including the alternative test procedure.Writing comments to doe should also send a copy of such comments to the petent.ron.shebik@hussmann.com,12999 St. Charles Rock Road, Bridgeton, MO 63044.

Send comments via http://www.regus.gov.Öhttp://www.regulations.govOn the website you have to enter your name and contact information.They are only visible to building technologies.In addition to their first and last name, organizational names (if available) and representative name, the contact information is not publicly visible to the sub -step (if available).If your comment is not processed correctly due to technical difficulties, doe use this information to contact you.If DOE cannot read your comment due to technical difficulties and cannot contact you to clarify it, you cannot contact it.Doe may not be able to take your comment into account.

However, your contact information is publicly visible if you include it in the comment or in a document that is attached to your comment.All information that you do not want to be viewed should not be included in your comment or a document that is attached to your comment If this instruction is followed, the persons who look at the comments will only be the first and the last name,The names of the organization, the correspondence with comments and all documents that are sent with the comments.

Do not sendhttp://www.regulations.govInformation on which the disclosure is limited by law, such ashttp://www.regulations.govIt cannot be referred to as CBI.The comments received via the website will return all CBI claims to the information sent.To get information about sending the CBI, you will find "Confidential trade information" section.

Doe -pcessant rateshttp://www.regulations.govBefore the post.Comments are usually published a few days after sending.However, if large comments are processed at the same time, your comment may not be visible for up to several weeks.Please keep the comments tracking number.What.What number is followed.What kind of number.What number is followed.What kind of number.What kind of number.What kind of numberhttp://www.regulations.govOffer after successfully sending your comment.

Send comments after and e -mail, hand delivery/mail or post.Comments and documents sent by and e -mail, hand delivery/post or post are also publishedhttp://www.regulations.gov.If you do not want your personal contact information to be publicly visible, do not add them to your comment or a document that accompanies you.As soon as this indicates your contact information for a presentation letter.E -mail, telephone number and optional correspondence address.The presentation letter will not be publicly visible, provided that it does not contain any comments.

Add contact information whenever you send comments, data, documents and other information if you send it.It is not necessary to send printed copies.Faxes are not accepted.

Comments, data and other information that is sent electronically to DOE should be provided in file format, Microsoft Word or Excel, Wordperfect or Text (ASCII) (PDF) continuation format, Microsoft Word or Excel.You have to bear the author's electronic signature.

The campaign campaign form.Send campaign form letters from the origin organization in loose between 50 and 500 PDF form letters or as form letters with a list of supporters that have been put together in one or more PDFs.This shortens the processing and publication time of the comment.

Confidential business information.According to 10 CFR 1004.11, anyone who sends information as confidential and freed from the law of public disclosure should be confidential and a copy of the "non -denominational" marked document with the information that is deleted as confidential.A CD if you viable.Do Doe will make your own decision about the confidential status of information and then meet.

It is a DAU guideline that all comments can be included in the public document without changes, including the personal data given in the comments (with the exception of information that is freed from the disclosure of the public).

The law of politics and energy and preservation, as is changing ("epca"),2 The US Ministry of Energy ("doe") approves the energy efficiency of various consumer goods and certain industrial devices (42 US US equipment 6291-6317).3 EPCA (42 U.S.C. A large number of provisions to improve the energy efficiency of certain types of industrial devices. There are changes caused by the energy independence and security law of 2007, public law 110-140, § 312 (December 19, 2007).Equipment includes walking in cooler and walk-in freezer cooling systems (together "walk-in") is the focus of this document (42 U.S.C. 6311 (G)).

The EPCA's energy conservation program essentially consists of four parts: (1) test, (2) labeling, (3) Standards for the energy conservation of the federal government and (4) certification and application procedures.Relevant EPCA determinations include settings (42 USC 6311), energy preserving patterns (42 U.S.C. 6313), test procedures (42 U.S.C. 6314), labeling provisions (42 U.S.C. 6315) and the authorization, information and reports from manufacturers (42 US.6316).

Federal test requirements consist of test procedures that the manufacturers of equipment use as a basis for: (1) certifying what makes their equipment conform to the applicable power protection standard(s) and (2) representations of the efficiency of that equipment (42 U.S.C. 6314(d)). Similarly, the DOE should use these test procedures to determine whether the covered device conforms to relevant EPCA standards (42 USC 6316 ((42 USC) (6316 A); 42 U.S.C. 6295 (s))

At 42 U.S.C.6314, EPCA establishes the criteria and procedures and requires that the test procedures be excessive (42 U.S.C. 6314(a)(2)). The test procedure for walk-in refrigeration systems is contained in the Federal Regulations Code ("CFR") at 10 CFR Part 431, Subpart R, Schedule C,,Uniform test method for measuring liquid capacity and walk-in Awef on refrigerator and freezer refrigeration systems("Appendix C").

Under 10 CFR 431.401, any interested person can send a petition to do without the requirements of the DOE test procedure.Dure grants a resignation of the test procedure if the basic model for which the waiver has been requested model test according to the prescribed test procedures or that the prescribed test procedures rate the basic omodel, add all the alternative test procedures known from the petent to evaluate the equipment type performanceIn a way that is representative for the energy consumption characteristics of the basic model, resignation is subject to conditions, including the adhesion of analysis test procedures, which are specified by DOE.10 CFR 431.401 (f) (2).

Once viable after granting a withdrawal, it will be published in the publicationFederal registrationA warning of the proposal to change its regulations to eliminate the continuation of this resignation.10 CFR 431.401 (L).Federal registrationA final rule for this effect.Identity.

The withdrawal process also provides that the DOE can grant a preliminary resignation.It is likely that the underlying application for cancellation will be granted and/or if the DO determines that it would be desirable for reasons of public order if the resignation of the resignation. 10 CFR 431.401 (E) (2).The DOE: (i) will be the date of a year after the issuing of a preliminary cancellation.Federal registrationa determination for resignation;or (ii) in the publication in theFederal registrationA new or changed test procedure that deals with the problems presented in the resignation.10 CFR 431.401 (H) (1).

If DOE changes the test procedure to solve the problems presented in a resignation, the resignation is automatically concluded on the date on which the use of this test procedure is required to demonstrate compliance. 10 CFR 431.401 (2).

On July 16, 2020, Hussmann waived the procedure for absurding and a preliminary resignation of the walk -in cooling systema.4 ).2Direct expansion unit basic subject models (Hussmann, No. 1 in pp. 7-8) .hussmann notes that the test conditions of the Institute for Air conditioning, heating and cooling ("Ahri") described in Table 15 and Table 15 Standard 1250-2009,,Standard for the performance classification of refrigerators and freezer cabinets("Ahri 1250-2009") (for refrigerator units and freezing units that have been tested themselves), not reached by the specified basic models and do not match the operation by Hussmann'sco2Direct expansion unit Schiefränke.hussmann explained that Co2It has a critical temperature of 87.8 ° F5 , eTherefore, the required net input saturation temperature of 105 ° F and the temperature of the required 9 ° F liquid input -SUB fluid that is required in the DOE test procedure is CO2Booster -System (Hussmann, Nr. 1 in S.3).

Hussmann's statements refer to the difference in the thermodynamic properties between CO2And other lemonades.In modest pressure (Dh,,Under the critical point), many substances move from a solid to a liquid with increasing temperature.For example, a pure substance as water transports from steam to a certain temperature.FOR EXAMPLE.212 ° F, with atmospheric pressure.To the extent to which heat is added during a gas transition, the backwards occurs when the heat is removed.However, the transition temperature depends on the pressure.The higher the pressure, the higher the transition temperature.This is a basic principle in cooling systems that work at two associated pressure levels at two temperatures.A. Soda absorbs heat when it is low temperature and pressure, converts into gas and cools the surrounding room.At high temperature and pressure, the soda continues to high pressure in a liquid and an accelerator (pressure reduction device) are used to (condenses) the pressure after soda to reduce soda with high pressure.

All soft drinks have a "critical pressure" and a "critical temperature" that cannot coexist with fluid and steam phases.In this critical point, soda is a gas and its temperature rises or decreases when it is added or removed.Critical pressure is so high for all conventional soft drinks that it is never exceeded in typical cold cycles.example6 With an associated critical temperature of 161.7 ° F.in2It behaves differently, with a critical pressure of 1,072 PSIA in connection with a critical temperature that is well below 87.8 ° f.The refrigerant temperature should be slightly higher than 87.8 ° F and the performance of many cooling and air conditioning systems is tested using an ambient temperature of 95 ° F, as indicated in Ahri 1250-2009 Section 52The soda is in an overcritical state (Dh,,A state with pressure over critical temperature) and heat is transferred to the environment.How useful cooling is made available at a critical temperature,2It is said that the cycles are transcritical.

The transcritical nature of the CO2Usually it takes a more complex cooling cycle design to fix the efficiency of conventional lemonades (Dh,,R404A, R407A, R448A etc.) during operation under high temperature conditions.To increase efficiency and prevent overheating (or use overheating to prevent (or use) multiple ball and intercool stadiums.2It is cooled in the gas refrigerator of a transcritical reinforcement system and extends with a high -pressure control valve and is delivered to an under -critical compressed flash tank.Be separated in the flash tank.A unit fridge in a CO2The reinforcement system would be supplied with flash -fluid flash with flash tank by expanding valves in which the soda is evaporated.Dambled soda will later be compressed into a gas cooler pressure at the end of the cycle (Hussmann, No. 5).

Hussmann also applies for a preliminary resignation from the existing DOE test procedure.Donation grants a preliminary resignation if it is likely that the application for withdrawal is granted and/or if the DOE determines that it would be desirable for public policy to grant an immediate relief.Waiting for a determination of the cancellation petition.Ver10 CFR 431.401 (s) (2).

Based on the statements of the petition, a preliminary resignation is missing, the prescribed test procedure is not suitable for Hussmann's CO2Direct expansion unit -coolers and test conditions are unavailable because2The refrigerant has a critical temperature of 87.8 ° F and the current DOE test procedure requires a net input saturation temperature of 105 ° F. The inability to achieve test conditions for the declared basic models to combat the operating conditions of Hussmann devices.

EPCA requires manufacturers to use the applicable DOE test procedures by making electricity consumption representations and energy consumption costs for covered devices (42 US US US devices).Applicable doe energy savings standards.Alternative tests for the basic models that are dealt with in the intermediate order of the withdrawal.

Hussmann tries to test and classify certain CO2Direct expansion unit Basic models cooler with modifications in the doe test method refrigerators.Hussmann also recommends that subject units are used in transcritical CO2Booster systems, calculations in Ahri 1250-2009 Section 7.9 should be used AHRI 1250-2009 is prescribed by the doe test procedure to determine AWEF for all tested refrigerators (see 10 CFR part 431, sub-section C, section 3.3.1).17 (eer [Energy Efficiency Zinex] for remote commercial and memory cabinets) should be used to determine EER values and power consumption for the subject CO2Cooling systems for direct expansion units, as required in the DOE test procedure.

Doe analyzed the application of Hussmann, the proposed test approach, industry materials in relation to CO2Transcritical reinforcement systems and Hussmann consumer materials, including locations and product specifications for the basic models listed in the petition of Hussmann.com.Precise measurement of the energy efficiency of certain basic models, while they alleviate test problems in connection with the implementation of the cooler and walk-in freezer test for these basic models by Hussmann.CO review.2The cooling market confirms that the test conditions of the test approach proposed by Hussmann are representative of the operation of a unit fridge used in a transcribed CO2amplificationsystem.co2This is cooled down in the gas refrigerator of a transcritical reinforcement system2For an under -critical pressure flash tank in which the liquid and soda steam phases are separated.The liquid is then divided and the uniform cooling cabinets receive the soda in the same state, which with the use of the same net input saturation temperature for medium and low temperature corresponds to systems in the test approach of Hussmann.2Project cooling system projects show that the 38 ° f 38 ° C cooler -saturation temperature proposed by Hussmann is representative of CO2Booster Systems (Hussmann, No. 5).With regard to the use of EER values in Ahri 1250-2009 Table 17 to determine the representative energy consumption of the compressor for CO2Unit cooling systems, research on the performance of various CO configurations2Booster systems show that the Enhanced Co.2Cycles (such as those used in transcritical reinforcement systems) can correspond to conventional soft drinks in the average annual efficiency (Hussmann, No. 2).In Ahri 1250-2009 Table 17 to determine the power consumption for CO2Vaporizers of the reinforcement system, despite these improved values that were originally set for systems with conventional refreshment drinks.As a result, Doe found that Hussmann's application for withdrawal was likely to be granted.In addition, he found that for reasons of public policy it is desirable for reasons, they result in Hussmann immediate relief and waits for a determination of the application for withdrawal.

For the reasons declared, it isorderedIt is:

(1) Hussmann should test and evaluate the following CO2Direct expansion unit Basic models cooler with the alternative test procedure defined in paragraph (2).

Basic models for which a resignation is requested:

(2) The basic models from Hussmann identified in paragraph (1) of this intermediate order must be tested according to the test procedure for the cooling and freezing cooling systems of walk-in and walk-in hiking methods in doe at 10 CFR part 431, underproof C (Appendix C ("Appendix C"), with the exception that the test condition of the liquid input saturation temperature and the temperature state of the sub-fluid to 38 ° F or 5 ° F for the refrigerator should be modified for the units and walk-on-walk-US cooling blocks of the freezer unitas described below.All other requirements of the regulations in Appendix C and DOE are still applicable.

In Appendix C in Section 3.1.General changes: test conditions and tolerances,Review section 3.1.5. To read the following:

3.1.5.Tables 15 and 16 must be read as follows:

(3)Representations.Hussmann cannot represent the energy efficiency of a basic model for compliance, marketing or other purposes listed in paragraph (1), unless the results of such tests.

(4) This average treading order must remain in force in accordance with the provisions of 10 CFR 431.401.

(5) This medium order of the resignation is issued on the condition that the statements and representations provided by Hussmann are valid.Invalid waiver in relation to the test procedure.CV or change this waiver at any time if the factual basis that is based on the petition for the intermediate order of withdrawal is wrong or the results of the alternative test procedure are not representative of the actual energy consumption features of the basic model. 10 CFR 431.401 ((K) (1). From the same way, Hussmann can apply for the DOE to save or change the medium order of resignation or change for other suitable reasons. 10 CFR 431.401 (2).

(6) The issue of this intermediate regulation of withdrawal does not release Hussmann from the applicable requirements that were set in 10 CFR part 429.

DOE makes decisions about exceptions and intermediate exceptions only for basic models that are specially defined in the petition, not in future models that can be produced by the petent.Hussmann can send a new or changed petition to withdraw and apply for the provisional cancellation as necessary for additional basic models from CO2Cooler of direct expansion unit.Alternatively, Hussmann can request that donations expand the scope of waiver or preliminary cancellation to additional basic models in accordance with 10 CFR 431.401 (G).

This document of the energy department was signed on December 28, 2020 by Daniel R. Simmons, deputy secretary for energy efficiency and renewable energies, in accordance with the secretary for energy -leaned.This document with the signature and the original date is kept up by the doe.The Federal Registration Officer of the Subsledhed Dock was only allowed to sign the document in an electronic format for publication and send energy for administrative purposes and according to the requirements of the Federal Registration Office.This administrative process in no way changes the legal effect of this document to the publication in theFederal registration.

Federal Act of the Federal Law (49 U.S.C. 5339 (C)) authorizes the TLC to grant low bus subsidies or no emissions by a competition process, as described in this communication.LOW-No offers the state government authorities of the state government authorities funds and purchase or rental contract of zero and rental agreement.TLC recognizes bus vehicles for traffic income.This program supports the strategic goals and goals of TLC through timely and efficient investments in public transport.This program also supports the best initiative of the president in order to build the American ingenuity for the establishment of a modern infrastructure and a F mobilization and fair energy.In addition, on January 20, 2021, the low program and the goals of the Executive Ordinance of the President will advance how public health and the environment are protected and science can be restored to combat the climate crisis.

Federal Act on Public Transport (49 U.S.C. 5338 (a) (2) (m)) approved $ 55,000,000 in the 2021 financial year for the Baixo-no program.An additional $ 125,000,000 for the program with low NO for a total of 180,000 USD for $ 180,000 for subsidies as part of this program.Additional funds available before the project selection can be allocated.

In the 2020 financial year, the program received a registration for 147 projects in which a total of 513 million US was the highest amount granted to a single candidate, about 7 million US dollars, and no state received more than 5.4 %the total available financing.

The FTA will grant the impractical authority to incur costs for selected projects from the time of EF 2021.The project selection will be available on the FTA for projects that were not cost before the project selection was announced.

The elegible candidates include certain recipients, states, local government agencies and Indian tribes.Suggestions for financing projects in rural (non -urban) areas can be submitted as part of a consolidated state proposal.For beneficiaries, the candidates must be viewed to demonstrably prove the legal, financial and techniques that are necessary for the reception and management of federal funds within the framework of this program.States and other legitimate candidates can send consolidated proposals to projects in urbanized areas.Suggestions can contain projects that are to be implemented by the recipient or their elegible sub -recipient.Regents are units that are otherwise justified recipients in this program.

As the Consolidation Act 2021 is permitted, candidates for the low program can send registrations that contain partnerships with other companies that want to participate in the implementation of the project, including but not limited to certain vehicle manufacturers, suppliers, suppliersof devices, owners or operators of related institutions or project consultants.If an application with this partnership for financing is selected, the competitive selection process is considered in order to request a competitive acquisition as part of 49 US US US US.The candidates are warned that changes in the proposed partnership require a written approval of the TLC, match the scope of the approved project and may require a purchase purchase.

The maximum participation of the federal government in projects that affect the sewing or recording of traffic buses (including clean fuel or alternative fuel vehicles) to comply with compliance with compliance with the clean air right is 85 % of the net costs of the project.

The maximum participation of the federal government for the costs for the purchase, installation or construction of vehicles, devices or facilities (including clean fuel or devices or devices in connection with alternative fuel vehicles) is to comply with compliance with compliance with the clean air lawis 90 %of the cost of net design of such devices or facilities that are due to compliance with the Clean Air right.The price winner must indicate the costs for specific, discrete and vehicle -related devices associated with compliance with the Clean Air right to calculate a maximum participation of the Federal Association, 90 % for these costs.

The federal costs of other projects should not exceed 80 %.

The elegible correspondence sources include the following: money from non -state sources, in addition to the income of the provision of public transport services;Income from the sale of advertising and concessions;Amounts received as part of a service contract with a state agency or local contract service agency or private social service organization;Income generated from Value Capture Financing Mechanisms;Fund of a UN distributed surplus;Transport development or correspondence in Sorty can be used for local correspondence if they are identified and documented in the application.

As part of the low program at N-NO (49 U.S.C. 5339 (C)), projects or programs in a legitimate area for: (1) Purchase or rental agreement from low or emissions busy buses include;Low emission or without rented electricity Source (3) Construction or rental facilities and equipment in connection with low or without buses (4) Construction of new public transport facilities for low or emissions (5) or emissions (5) or without emissions;rehabilitation or improvement accommodation of buses with low iDel or not (49 ands.c. legitimate projects in connection with the acquisition or rental agreement of buses or lows or without emissions that are and are and are more reduced by the power consumption and emissions or without emission buses more or without emission busesPart of the long -term integrated fleet management plan of the recipient.

One or no one with a low emission bus or none is defined as a passenger vehicle that is used to provide public transport that significantly reduce energy consumption or harmful emissions, including direct carbon emissions compared to a standard vehicle.The legal definition includes traffic buses zero emissions that are defined as buses that do not produce direct carbon emissions and no particle problems in the context of possible operating modes.Hydrogen and electric buses from the battery.According to the FTA Bust test Ordinance, all new traffic bus models should successfully complete FTA -Bus tests for production buses (49 CFR part 665) with funds that are granted in the low -no program.All traffic vehicles have to be bought by the factory certified traffic vehicles according to the disadvantaged regulations of the business company (DBE) (49 CFR part 26).The development or implementation of prototype vehicles is not justified in the program with low NO.

Recipients may be up to 0.5 % of the workforce for the development of the legitimate workforce within the framework of the Federal Representative Act (49 USC 5314 (B)) and 0.5 % for training at the National Traffites Institute.Must identify the proposed use of funds for these activities in the project proposal and identify separately in the project budget.

If a unique project proposal affects several providers of public transport, e.g.

Registration must be sent electronically by sendingGRANTS.GOV.General information to sendApplications throughGRANTS.GOVcan be found inwww.fta.dot.gov/howtoapplyAlong with specific instructions for the forms and attachments required for shipment. Mailing and faxing of proposed proposals will not be accepted. A complete proposal submission consists of two forms: the federal SF-424 request (available inGRANTS.GOV) and the Fiscal Year 2021 Low Program Supplemental Form (downloaded fromGRANTS.GOVor the FTA website athttps://www.transit.dot.gov/funding/grants/lowno).To send the requested information can delay the revision or disqualify the application.

A complete submission of a proposal consists of two forms: (1) The SF-424 Federal Assistance request;and (2) The supplementary form for the liter number program from EF 2021. The additional form and all documents support must be attached to the SF-424 "attachment" section.The application must contain answers to all sections of the SF-424 order to support the federal government and the supplementary form, unless this is optionally specified.The information about the additional form is used to determine the candidate and the authorization of the project for the program and the evaluation of the proposal to the selection criteria described in the party and this message.

The FTA only accepts a supplementary form for SF-424.FTA encourages states and other candidates to send a single additional form that contains various activities that are to be assessed as a consolidated proposal.Suggestions for individual consideration by TLC, each proposal must be sent using a separate SF-424 and supplementary form.

Applicants can add additional support information to send SF-424, including support letters, project budgets, fleet status reports or relevant planning documents.Each support documentation must be described and referred by the file name in the corresponding response section or cannot be checked.

Information such as the names of the candidate, the required value of the federal government, the local correspondence value, description of the served areas, etc.The candidates have to fill out all fields into the form built into the form.The candidates should use the "error test package" buttons and the "validate form" validation buttons in both forms to check all the necessary fields in the forms and ensure that the specified federal and local values are consistent.

The SF-424 Federal Assistance request and the supplementary form request candidates according to the required information, including:

Every candidate must be registered in SAM, which is taken into account in SAM on what the applicant is taken into account about an active federal prize or an application or planning by the TLC.These requirements do not apply if the applicant has approved exemption approved by the Federal Act for Subsidents and Agreements (2 CFR 25.110 (D)).The TLC cannot achieve a price if the applicant meets all the requirements of entity recognition and applicable SAM.If a candidate has not fully met the requirements if the FTA is ready to achieve a price, the TLC can find that the applicant is not qualified, you will receive a price and use this statement as the basis for obtaining a federal prizeother applicants.The non-federal companies that receive a federal prize in civil, criminal or administrative procedures to SAM (currently the integrity and performance information system and federal integrity (Fapiis)) to ensure that the registration information is up to date and meet the federal requirements.The candidates have to find 2 CFR 200.113 to get more information.

All candidates have to provide exclusive entity recognition, that of Sam.SAM registrations take 3 to 5 working days, but since there may be unexpected steps or delays (e.g. recommends to enable up to several weeks of sufficient time to carry out all steps. To get additional information about obtaining an exclusive entity recognitionshewww.sam.gov.

Project suggestions must be sent electronically by sendingGRANTS.GOVat 11:59 p.m. from the east on April 12, 2021.GRANTS.GOVAt the time of submission, add a date stamp for each application.The proposals submitted after the deadline are only taken into account under extraordinary circumstances that are not under the control of the candidate.The postal and fax programs are not accepted.

Within 48 hours after sending an electronic registration, the applicant must receive an e -il message fromGRANTS.GOVWith confirmation of a successful transfer forGRANTS.GOVIf a validation warning is received with failure or incomplete materials, the applicant must address the reason for the validation with the failure, as in the e -mail warning and reset before shipping in the supplementary form, which indicates that this is a resolutionis.

The TLC calls on the candidates to send inquiries at least 72 hours before the due date to get time to get validation messages and to fix problems that may have led to a rejection notification.GRANTS.GOVThe planned maintenance and interruption hours are announced in theGRANTS.GOVLocation on the Internet network.Not expanded due to the maintenance of the programmed location.

Candidates are asked to start the registration process in theGRANTS.GOVWebsite long before shipping time.Registration is a process with several steps that can take several weeks for an order to be sent.Registered candidates may still have to take measures to keep their registration up to date before the registrations can be successfully made: (1) Sam registration is renewed annually and (2) people who on behalf of the representative of the authorized organization(Aor) submit submissions, must be approved inGRANTS.GOVto send from AOR.

Funds according to this NOFO can be used to reimburse candidates for legitimate expenses.

Applicants are asked to identify scaling financing options if inadequate financing are available in order to finance a fully specified project.Demanding to achieve program goals and meet all relevant program requirements.The applicant must provide a clear explanation of how the project budget would affect a reduced sentence.Scalable option.

All applications must be sent through theGRANTS.GOVLocation on the Internet network.The TLC does not accept applications on paper, fax machine, e -mail or other means.To obtain information about the application of the application, see section D.1., Address for the request of the registration.

Projects are mainly evaluated by the answers given in additional form.Additional information can be provided to support the answers.However, reference must be made directly to the additional form to each additional documentation, including the file name in which additional information can be found.The TLC becomes.Evaluate the proposals for the program with low No. NO on the basis of the criteria described in this communication.

If a candidate suggests that autonomous vehicles or other innovative motor vehicle technology implement, the application must prove that all vehicles meet the applicable safety requirements, including the National Traffic Safety Administration on Highways (NHTSA) and the administrative company Motor Security Fedal (FMCSA)managed).In particular, the inquiry must show that vehicles that were acquired for the proposed project are in the context of a liberation or resignation, which has already been granted by NHTSA, FMCSA or both agencies, or (2) directly project FMVSS exceptions or exceptions,FMCSR or other regulations require, and if the project requires exceptions, present exceptions to present a plan to get them.

Since the purpose of this program is to finance vehicles and facilities, orders are evaluated based on the quality and the extent, in which you will demonstrate how the proposed project will meet an inappropriate need for capital investments in vehicles and/or support facilities.A candidate can prove that additional or improved loading or maintenance systems are required for low or emission vehicles that have to replace existing vehicles that have exceeded their minimum experience for useful life or need additional vehicles to meet the current passenger requirements.

The TLC will take into account the answers of a candidate to the following criteria when evaluating the need for capital investments based on the proposed project:

I. Consistency with the long -term fleet management plan:As from the Federal Act of the Federal Law (49 U.S.C. 5339 (C) (5) (B)), all project proposals must prove that they are part of the long -term integrated fleet management plan of the intended recipient, as shown by means of an existing administrative asset, management plan, fleet or programOr a documented guideline or guideline in the same way.These plans must be attached to the application of the candidate and the previous experience of the candidate with low or relevant emission vehicle technologies.

II) for low -emission or emission -free bus projects (replacement and/or expansion):The applicants must provide information on the age, state and performance of the vehicles to be replaced by the proposed project.The proposal should address whether the design corresponds to the TLC replacement installments guidelines. Emission or emission-free vehicles that are financed within the framework of this program are not excluded from the standard rate of the FTA, which apply and are calculated for the entire fleet of the agency.

III) for bus systems and equipment projects (replacement, renovation and/or expansion):Applicants must provide information on the age and state of the assets to be renovated or replaced in relation to its minimum useful life.

Applicants must demonstrate how the proposed project meets the legal requirements of the low-no program (see 49 U.S.C. 5339 (C) (5)).In particular, the FTA will check the quality and the scope in which the proposals show how the proposed project: (1) lowers energy consumption;(2) reduce harmful emissions;and (3) Reduction of direct CO2 emissions.

The energy consumption goes:The candidates should describe how the proposed project reduces energy consumption.TLC evaluates applications on the basis of the degree in which the proposed technology reduces energy consumption compared to the most common technologies of vehicle drive.

II.The candidates should prove how proposed vehicles or facilities reduce the emission of particles, create local air pollution, which leads to local environmental health problems, smoke and harmful ozone concentrations.The TLC evaluates the rate of particle emissions by the proposed vehicles or vehicles, which are replaced by the proposed installation compared to the emissions of vehicles that are replaced by the proposed project or moved to the replacement fleet comparable standard.

III.Reduces direct carbon emissions:The candidates should prove how proposed vehicles or facilities reduce greenhouse gas emissions from traffic vehicles.The emissions of vehicles that are replaced in the replacement fleet due to the proposed project and comparable standard bus or moved to the replacement fleet.

Candidates should prove how the proposed project corresponds to local and regional planning documents and priorities of the local government.The traffic and/or contingency/illustration projects identified in the long-haul plan, which are included in this plan, or in the coordinated public transport plan of locally developed human services.Candidates can send copies of the relevant pages of such plans to support their application.TLC will consider how the project will support the regional goals, and candidates can be able to send support letters from local and regional planning organizations who can use these plans to attest to the testimony of the proposed project.

The proof of additional local or regional prioritization can include support for the project of the local government, public authorities and non -profitable or private partners of the local government.

Applicants should identify the source of local cost division and describe whether these funds are currently available for the project or must be protected if the project is selected for financing.With the project.The candidates should send the availability of funds for the availability of funds to the project;for the project;for the project;for the project;for the project;for the project;for the project;for the project;for the project;for the project;for the project;for the project;for the project;for the project;for the project;Example, including a state decision only for the incremental costs of new technologies for the costs for the exchange of vehicles through standard drive technologies.

TLC classify higher projects if concession funds may be necessary within 12 months of selection and the project can be implemented within a reasonable time.Environmental evaluation (EA) or environmental impact declaration (ice) according to the National Environmental Policy Law (NEA) from 1969, as changed.As such, the candidates have to send information that describes the expected path and the project schedule about the environmental review process.What is the metropolitan transport improvement program (tip) and/or the program to improve transport throughout the state (STIP) can be changed into the proposed project.

When assessing whether the proposed implementation plans are appropriate and complete, the FTA will check the proposed project implementation plan, including all the necessary project milestones and the general project bar.For projects, for the formal coordination, permits or licenses of other agencies or projects, partners are required, the candidate must prove coordination with these organizations and their support for the project, as through support letters.

For project suggestions in which a partnership with a manufacturer, supplier, consultant or other third parties is involved.The companies involved in the project that are not appointed in the application should be selected by a competition purchase.

The candidates have to prove that they have technical, legal and financial capacities to carry out the project.can.

In addition to other FTA employees who can check the proposals, a technical assessment committee evaluates the proposals based on the published evaluation criteria.The FTA administrator the final selection of the projects for program financing. The determination of the assignment of the program fund can take into account the geographical diversity and size of the transport systems that receive the financing and maintenance of the candidate from other competition prices.Draw the value that an individual applicant can receive.

After applying the above criteria, in support of the President's Executive Order dated January 20, 2021 to protect public health and the environment and restore the science to address the climate crisis, the FTA Administrator will review applications that provide additional air quality benefits can the app review. Applicants must identify any areas of non-compliance or maintenance under the Clean Air Act in the proposed service area. Non-performing or non-service areas should be limited to the following applicable national air quality standard pollutant criteria: carbon monoxide, ozone, and particulate matter 2.5 and 10. The U.S. Environmental Protection Agency Green Paper (available inhttps://www.epa.gov/green-book) is a publicly available resource for non-acquisition and maintenance of territory data. This consideration will advance the goals of the Executive Order, including the goal of prioritizing environmental justice (EJ).

In addition, the FTA will consider the benefits to EJ communities when considering applications received under this program. Applicants must identify all EJ populations located within the proposed service area, andIf you describe the advantages that are intended for this population, the candidate receives a license as part of this program.A formal analysis by EJ, which is usually included in transport planning or in environmental regulations, is not requested.

In addition, the ATC administrator will consider applications that contain a financing request for activities for the development of workforce that improve the technical experience of American traffic employees.

Before a prize, the TLC must check all information about the candidate and view the performance systems and integrity information of the accessible Federal Award via Sam.A candidate can review and comment on all information about itself as a previously awarded the Federal Authority, the TLC will take into account comments from the applicant in addition to the other information in the named integrity and performance system by a judgment on integrity, business ethics and the performance registration of the candidateBy concluding the risk check that candidates have presented, as described in the office for uniform administrative and budget requirements for federal prices (2 CFR 200.205).

The FTA will announce the final project selection on the FTA website.Recipients should contact their TLC regional offices in order to receive additional information on allocations for projects in the Baixo no-no program.The moment the project selection is announced, pre-premium authority for the selected projects.Before the announcement, there is no authorization for these projects.

LOW program funds are not available to states, named recipients, local government agencies and Indians.There is no minimum or maximum concession price.Electable recipients for legitimate activities are taken into account for financing.As soon as the financing of restrictions are financed, selected financing candidates can receive less than the originally requested value.In these cases, the candidates must be able to prove that the proposed projects are still profitable and can be completed with the value granted.

At the time of the selection, the FTA will issue specific guidelines for the recipients regarding the precressed authority.The costs will be incurred.To get more information about the TLC directive for the pre-premium authority, contact the latesthttps://www.transit.dot.gov.

If the winners are selected, the winners apply for a concession via the FTA traffic tracking management system (trams).All recipients of the N-N-O program are subject to the granting requirements of the program for urbanized area formulas (49 USC 5307), including this of the urbanized area formula Circular Program: Program guide and application instructions "(FTA C.9030.1e).C.5010.1) and the protection of the public transport law (49 U.S.C. 5333 (b)). Technical support in relation to these requirements is available in every FTA regional office.

The TLC requires all capital acquisitions to meet TLC America's purchase requirements (49 U.S.C. 5323 (J) and 49 CFR part 661), for which all iron, steel or manufacturing products must be manufactured in the United States.An increase in the phases of the domestic content for the powerful inventory between the 2016 financial year and the 2020 financial year. For the 2020 financial year and beyond, the costs for components and sub -components produced in the USA should 70 % of the costs of exceeding costs of all components.It has not changed that the final assembly of the rolling material should take place in the USA.September 2016 (81 FR 60278).The candidates have to read the guideline guidelines carefully.Every proposal that require a resignation in the application the objects for which a resignation is requested.The candidates should not continue with the expectation that exceptions are granted.

The TLC demands from its recipients who receive planning, capital and/or operational support in order to grant cousin contracts that are over 250,000 US dollars in TLC funds in a federal financial year in accordance with the provisions of the Ministry of Transport, regulation company DBECompany (DBE) (49) (49 CFR part 26).The candidates should expect to involve all funds granted without define their general DBE for vehicle acquisitions.They are subject to the regulations of the DBE program.The rule requires that vehicles that are supported by vehicles, which are supported by vehicles, must be offered by TLC, companies that manufacture vehicles or carry out post-production, a DBE program plan and target methodSend to the goals, since a vehicle renovation on a request for new or outdated vehicles with a vehicle was available to react to the remanifator changes or modernization after production (modernization after production (FOR EXAMPLE,By replacing main components such as an engine to provide a "new" vehicle, the vehicle recipient is considered a manufacturer of transit vehicles and must also comply with the DBE regulations.

The FTA issues a certification/agency letter for the manufacturer of transit vehicles (TVM).Grant receiver must check compliance with these requirements by each unit before you accept your offer.FTA website underhttps://www.transit.dot.gov/regulations-and-guidance/civil-rights-ada/eligible-transit-vehicle-manufacturers.Please note that this list is not exclusive and the recipients have to contact the FTA before you accept bids from companies that are not listed in this web posting.Further information on the DBE requirements can be found from Scheryl Portee, Office of the Chief Counsel, 202-366-0840, email:Scheryl.portee@dot.gov.

The FTA encourages the candidates to inform suitable state traffic departments and planning organizations of the metropolises in areas that are likely to be met by the project funds available as part of these initiatives and programs.Selected projects must be recorded in long-term and transport improvement plansPrograms from states and metropolises before they are entitled to finance TLC.If the evaluation criteria are described, the FTA can be consistently contained when evaluating a project or already in these levels.

The applicant ensures that he will comply with all applicable federal laws, regulations, executive commands, guidelines, CRCs and other administrative requirements of the federal government in the implementation of a project that is supported by the granting of the subscription contract issued for them.The applicant goes from a written statement differently.The applicant must send certifications and guarantees before receiving a concession if he has not recorded current certifications.

The requirements for the report according to the premium include the electronic sending of federal financial reports and the progress reports of Marcos in the TLC Electronic Subvention Management System.Tram application.

As part of the conclusion of the necessary annual certifications and guarantees of the TLC recipients, a successful candidate must report the status of suspension or the debate about themselves and its directors.All federal concession agencies exceed 10,000,000 $ 10,000,000 for a period during the performance period.Of a price that is achieved in accordance with this message, the recipient must have the in Appendix XII.

Further information on this warning can be found at 202-366-7484 or by email atamy.volz@dot.gov.A TDD is available for deaf or hearing transactions in 800-877-8339https://www.transit.dot.gov/funding/grants/lowno.To ensure that the candidates receive precise information about the authorization or the program, the candidates are encouraged to contact questions directly and not through agents or third parties.The TLC team can also carry out briefings on the process selection and concession of competitive grants from EF 2021, on request.

This program is not subject to the Executive Order 12372 "Interpretation of the federal programs".GRANTS.GOVat 11:59 p.m. from the east on April 12, 2021.

For problems withGRANTS.GOV, Please contact usGRANTS.GOVby phone at 1-800-518-4726 or by email insupport@grants.gov.Contact information for TLC regional offices can be found on the FTA website inwww.fta.dot.gov.

O PRA, 44 U.S.C.3501-3520, and its implementation regulations, 5 CFR part 1320, require the federal authorities to issue two communications to obtain public comments on activities for collecting information before the OMB can approved paper crampons.Ver44 U.S.C.3506, 3507;5 CFR 1320.8 to 1320.12.In December 10, 2020, FRA released a 60 -day warning inFederal registrationRequest comments on the ICR, for which it is now requesting the approval of the OMB.Ver85 FR 79559. FRA has not received any comments in response to this 60 -day announcement.

Before the deciding of the OMB, if the proposed information is approved, it must deliver 30 days for public comments.Federal Act obliges that the OMB advantage or rejection of documents between 30 and 60 days after the public communication of 30 days.44 U.S.(B)-(C);5 CFR 1320.12 (B);Also see60 FR 44978, 44983, August 29, 1995. OMB is of the opinion that the 30 -day warning informs the regulated community about listing relevant comments, and the reasonable timely time agency for digestion of public comments before the decision.60 FR 44983, 29. August 1995. Therefore, the respondents must send their comments to the OMB within 30 days of publication in order to better ensure the entire effect.

Comments are invited to the following ICR: (1) If information is required to collect information in order to carry out your functions properly, including practical use, (2) The accuracy of FRA estimates on the burden on the information collection activities.Including the validity of methodology and assumptions to determine the estimates (3) possibilities for improving quality, use and clarity of the information collected;and (4) Methods for minimizing the burden on public information collections, including the use of automated collection techniquesOr other forms of information technology.

The following summary describes the ICR, which FRA sends to the publication of OMB, as is necessary:

Title:Metrics and minimum standards for the rail service of long -standing passengers.

OMB -Control number:2130-0632.1

Abstract:On October 16, 2008, President George W. Bush signed the law on investments and improvements in the railway, public law 110-432, 122 State 4907 (Pria).FRA and Amtrak jointly develop new or improved key figures and minimum standards in order to measure the performance of measuring and quality of the service of disorders of car railway operation, including cost restoration, punctual performance and protocol of delay, number of passengers, in board services in the areas of board services, stations,Facilities, devices and other services

Section 207 also requires a consultation of the surface traffic committee, railways, on the railway lines of which the Amtrakm trains, states, Amtrak employees and groups that represent Amtrak passengers if necessary operate.

Section 207 also determines that the metrics should at least include: the percentage of avoidable and fully assigned operating costs, which are covered by passenger income on every route;Passenger request by Mile Operated Train;Punctual performance measures and delays from the Zwischenpassing trains on the railway lines of each railway;And for long-haul routes, connectivity measures with other routes in all regions that currently receive the Amtrak service and the transport needs of municipalities and population groups that are not well operated from other distance transport forms are.

Section 207 also determines that the FR administrator collects the required data and a quarterly report on the performance and quality of the service of disorders of passenger train, including Amtrak cost restoration, passenger number, punctual performance and protocol of delay, causes of delay, Services on board, stations, facilities, equipment and other services.

In connection with the mandate of the congress, the FRA metrics and the minimum standards for the final rule of the Intercity passenger rail transport (49 CFR part 273) determine several metrics. 85 Fri 72971. On November 23, 2020, FRA,FRA has published an emergency processing request for an information collection, since FRA could not agree to the normal approval procedures, including all metrics defined in the final rule, including those that are recorded by the emergency permit.

Type of requirements:Review for the information collection that has currently been approved.

Publicly affected:Amtrak.

To form):N / D.

Universum interviewed: 2 1 (Amtrak).

Shipping frequency:Other.

Estimated annual answers:117.

Total estimated annual burden: 3 507 hours.

Annual annual estimated freight equivalent dollar:$ 66.365,00.

Under 44 US CF.A valid shoulder control no currently a number of control.

O PRA, 44 U.S.C.3501-3520, and its implementation regulations, 5 CFR part 1320, require the federal authorities to give the public 60-day notification to allow comments on the activities for the collection of information before the omb of activities are approved.Ver44 U.S.C.3506, 3507;5 CFR 1320.8 to 1320.12.In particular, FRA invites the interest groups to comment on the following ICR: (1) If the activities for collecting information for FRA are required to properly carry out their functions, including the way activities are practical use (practical use becomesif (practical service programs) (practical use will be (use of practical benefits "((practical benefit) () (2) The accuracy of FRA estimates for the burden on the information collection activities, including the validity of the methodology and assumptions for determining the estimates (3) Possibilities to improve the quality, the usefulness and clarity of the information collected; and (4) ways you minimize the burden on public information collections, including the use of automated collection techniques or other forms of information technology.Ver44 U.S.C.3506 (c) (2) (a); 5 CFR 1320,8 (d) (1).

FRA is of the opinion that the inquiries from public comments can reduce the administrative and paper diseases associated with the recording of information that require federal regulations.In summary, the comments obtained that the comments obtained drive three goals: (1) reduce reporting costs;in a "friendly" format to improve the use of such information;and (3) Rate the resources that were used for the restoration and creation of requested information.Ver44 U.S.C.3501.

The following summary describes the ICR, which FRA sends to the publication of OMB, as is necessary:

Title:Accident/incident reports and registration expectations.

OMB -Control number:2130-0500.

Abstract:Regulations for railway accident/incident report in 49 CFR part 225 require the railways to send monthly reports in which collisions, derailments and other accidents/incidents are summarized, the damage above regular dollars and certain wounds to passengers, employees and othersEmployees for the railroad contain property.If the report requirements and the required information on each category of accident/incident are clear, a different form is used for each category.

Type of requirements:Expansion without a change (with changes to the estimates) of an currently approved collection.

Publicly affected:Business.

To form):Def 6180.54; .55; .55; .56; .57; .78; .81; .97; .98; .107; .150.

Universum interviewed:765 railways.

Shipping frequency:On occasion.

Register Balca:

Estimated annual answers:89.057.

Total estimated annual burden:35,845 hours.

Annual annual estimated freight equivalent dollar:US $ 2.775.067.

Under 44 US CF.A currently valid omb control number.

Title 49 U.S.C.47105 (f) stipulates that the sponsor of an airport to which the appeals are distributed, the secretary for the time and in a form prescribed by the secretary form for the means.Therefore, the FAA notifies these sponsors from the airport about the necessary steps to ensure that the FAA has enough time to transfer and convert the remaining means of rights.

According to the requirements of public law, the AIP donation program is 115-254, the "Reauttion Act for 2018", which will publish on October 5, 2018, which AIP until September 30, 2023 and public law 116-260, "the publicLaw 116-260, "," "2018) operated.The law on transport, housing and urban development as well as related agencies, 2021 ”, which gives the funds of the EF 2021 for AIP until September 30, 2021.According to the legislation issued at the time of this communication, the AIP has approximately to us about 2.3 billion US dollars from legal remedies until September 30, 2021.

This warning only applies to airports that you distribute them to you, with the exception of not primary airports in the designated blocks subsidies.

An airport sponsor who wants to request one of its available appeals, including unused, but still after 49 US American American American American American American American.Time on Monday, March 15, 2021.

This warning must be written and all available legal funds have so far received for the 2021 financial year, including the non -required legal fund.These notifications are crucial to ensure efficient planning and management of the AIP., May 3, 2021. Final financing inquiries The grant application must be offered, not at estimates.Date above, as stipulated in 49 US C.47117. This means will only be available to the airport sponsor until theBeginning of the 2022 fiscal year. The data are possible on the basis of future law.

The FAA has found that this process and the deadline will optimize and facilitate the granting of tax grants from 2021.

The Ministry of Education (DE) corresponds to the law to reduce the document of 1995 (PRA) (44 U.S.C. 3506 (2) (a)) offers the general public and in federal authorities the opportunity to have the proposed, checked and checkedto comment and comment and comment on and continuous information collections.This helps the department to evaluate the effects of the requirements for information recording and to minimize the charge of public reports.It also helps the public to understand the requirements for the department's information intake and to provide the data requested in the desired format.The ED requested.Comments on the proposed information collection request (ICR), which was described below.The Ministry of Education is particularly interested in public comments that answer the following questions: (1) This collection is required for the corresponding functions of the department;(2) This information will be processed and used in time (3) the exact load estimate (4), since the department can increase the quality, benefit and use and the clarity of the information to be collected;and (5) how the department can minimize the burden of this collection via the respondents, including the use of information technology.

Collection title:Longitudinal study on early childhood, kindergarten class from 2022-23 (ECLS-K: 2023) Study delay.

OMB -Control number:1850-0750.

Type of review:No material or non -Sitstantial change for the currently approved information collection.

Sermon/affected audience:Individuals or families.

Estimated total number of annual answers:46.033.

Estimated total number of annual load hours:8.655.

Abstract:The Longitudinal Study Program (Early Childhood Longitudinal Study Program), which is carried out by the National Center for Education Statistics (NCUS) in the Institute for Education (IES) of the US Ministry of Education (DE), descriptive data on child development, early learning and school progress.ECLS program studies provide national data on the status of children at birth and in various places later;Children's transitions to non -parental care programs and training and school as well as the experiences and growth growth.of children through primary school classes.Longitudinal study of early childhood, kindergarten class 2022-23 (ECLS-K: 2023) is the fourth cohort of the first rows of longitudes of the first childhood.The study will promote research on child development and the development of children early learning, a detailed and comprehensive source of current information on AP -striking and early development of children, transits to kindergarten and beyond and will make progress at school.The collection of parent data from preschool enables the study to measure the influences on the development of children before entering formal training, including the domestic environments of children and access to early care and training.The request to carry out a field test of ECLS-K pre-detailed acquisition activities: 2023, from January to October 2020 to test materials and procedures on data recording in front of the prediction data, was approved in November 2019 (omb # 1850-0750 V.19)Inquiries for change inquiries in January and July 2020 (OMB #1850-0750 V.20-21).The request is to inform the omb and the public in the works, the ECLS field tests and the national study recruitment activities that are planned for 2021 are postponed to Warenidiu for a year and the study will now be the longitudinal study on the early childhoodKindergartens class 2023-24 (ECLS-K: 2024).From autumn from 2021 to autumn 2022. National studies of studies will also be postponed per year of 2023 The recruitment of national studies will be requested in a separate submission at the end of 2021.

This lawsuit is directed to the public and can be of interest to a wide range of stakeholders, including environmental and agricultural health;the chemical industry;Pesticide consumers and public members who are interested in sales, sales or use of pesticides.Others can also be interested, the agency has not tried to describe all the specific companies that can be influenced by this campaign.

The document for this action, identified by the EPA HQ-OOT-2018-0014 (ID) (ID)http://www.regulations.govOr in the office for pesticide programs Regulatory Public Docket (Opp -Docket) at the Environmental Protection Agency (EPA/DC), West William Jefferson Clinton Bldg., RM.3334, 1301 Constitution Ave.NW, Washington, DC 20460-0001.The public reading room is open from Monday to Friday from 8:30 a.m. to 4:30 p.m. without statutory holidays.The telephone number for the public reading room is (202) 566-1744, and the telephone number for the OPP document is (703) 305-5805.New information of the instructions of the visitorhttp://www.epa.gov/dockets.

The EPA ends cancellation orders to seven triadim phone product documents that were exhibited in twoFederal registrationMessages, January 12, 2021Federal registrationWarning (86 FR 2415) (FRL-10017-33) and A August 25, 2020Federal registrationWARNING (85 FR 52347) (FRL-10013-65), since they apply to the tridimone products from Bayer.com to the current status of revising triadim phone and, given the low frequency and severity of the incidents, order these voluntary cancellations as conclusions fromBayer.This request ends cancellation orders for Bayer Triadim phone recordings listed in Table 1 of this unit.

This lawsuit is directed to the public and can be of interest to a wide range of stakeholders, including environmental and agricultural health;the chemical industry;Pesticide consumers and public members who are interested in sales, sales or use of pesticides.Others can also be interested, the agency has not tried to describe all the specific companies that can be influenced by this campaign.

The document for this action, identified by the EPA HQ-OP-2009-0308 (ID) (ID)http://www.regulations.govOr in the office for pesticide programs Regulatory Public Docket (Opp -Docket) at the Environmental Protection Agency (EPA/DC), West William Jefferson Clinton Bldg., RM.3334, 1301 Constitution Ave.NW, Washington, DC 20460-0001.

Due to concerns for public health related to Covid -19, the EPA Docket Center (EPA/DC) and the reader room for visitors are closed with limited exceptions.The team continues to offer remote customer service and e -mail, telephone and web form.The latest status information on EPA/DC services and access to the newsletter can be found athttp://www.epa.gov/dockets.

This warning announces the changes to delete the changes requested in Section 3 of FIFRA (7 US American American American American registers).The data record is listed in Table 1 of this unit.

Table 2 of this unit contains the name and the registration address for the product register in Table 1 of this unit.The EPA company number corresponds to the first part of the EPA registration number listed above.

During the allotted 30-day public comment period, EPA received no comment in response to August 6, 2020Federal registrationNotification of receipt by the Agency of the application for voluntary exclusion of uses for the products listed in Table 1 of Unit II.

Pursuant to Section 6(f) of FIFRA (7 U.S.C. 136d(f)), EPA approves the proposed changes to the end uses of TCVP for the registry identified in Table 1 of Unit II. In this sense, the Agency determines that the registration of the products identified in Table 1 of Unit II is carried out. modified for end uses in dogs, cats and in kennels and kennels. The effective date of changes terminating the affected uses subject to this notice is February 18, 2021. Any distribution, sale or use of existing inventory of the products identified in Table 1 of Unit II. inconsistent with any of the disposals of existing stocks under Section VI. constitutes a violation of FIFRA.

In Section 6 (f) (1) of FITFRE (7 U.S.C. 136d (f) (1)) it is found that a register of a pesticide product at any time.Federal registrationAfter the period of public comments, the EPA administrator can approve this request.Federal registrationfrom August 6, 2020 [(Volume 85 number 152) (FRL-10012-80)].The comment period was closed on September 8, 2020.

Existing shares are the shares of the registered pesticides that are currently in the United States and were packed, marked and released for shipping before the date of the cancellation of the cancellation measure.

Chem-Tech is not allowed to "release for the transfer", since this term is defined on February 18, 2021 by 40 CFR 152.3, a product of the EPA Reg. 47000-123 by FIFRA (7 U.S.C. 136o) or for proper disposal.Chem-Tech can sell or distribute existing shares from EPA Reg. 47000-123 to exhausted.

People who are not registrars can sell, distribute or use existing stocks on canceled products until the deliveries are exhausted, provided that this sale, this distribution or use matches the previously approved labeling conditions or the cancellation products.

On October 13, 2005, the final rule of the Electronic Cross Media Report (Cromerr) was published in theFederal registration(70 FR 59848) and as part 3 of CFR.A Cromerr Tite 40, determines electronic reports as an acceptable regulatory alternative to paper reports and determines the requirements to ensure governmental authorities, tribal or places that are electronic reports within the framework of your EPA-Autorized programs should receive or start, register for the EPA to check or change these programs and obtain approval from the EPA.From electronic documents, receipt systems that the state, the trunk or the local government use to implement electronic reports.In addition, § 3,1000 (b) a (e) of 40 CFR part 3, sub -section D contains special procedures for program checks and changes to electronic reports, which is used according to the option of the state, the tribe or the government, instead of rejectable procedures in theExisting program -specific authorization regulations.An application that is anchored according to the sub -section must prove that the state, the trunk or the local government have sufficient legal authority to implement this electronic reporting components of the application that is recorded by the application use electronic documents that use themeet applicable sub -advanced requirements.

On September 17, 2020, the Department for Environmental Services in New Hampshire (NHDES) presented an application entitled Compliance Monitoring Data Portal for reviews/changes in its EPA -approved programs in titles 40 CFR to allow new electronic reports.EPA revised NHDE's request for checking/changing the programs approved by the EPA and based on this review, the EPA found that the application for the approval of authorized replacement/modifications in 40 CFR part 3, underproof D. according to 40 CFR 3,1000 (D), this, this, this.Warning of the EPAFederal registration.

NHDES was informed about the determination of the EPA to approved his application with regard to the above -mentioned authorized programs.

In addition, in today's warning, the EPA informs the interested parties of persons that they can apply for a public hearing about the measures of the EPA in order to approve New Hampshire's application for the review of their authorized program for public water systems below 40 CFR part 142,,According to 40 CFR 3. 1000 (f).The inquiries for an audience must be sent to the EPA within 30 days of today's publicationFederal registrationperceive.These inquiries should contain the following information:

(1) Name, address and telephone number of the individual, organization or other facilities that request an audience;

(2) A brief explanation of the interest of the person requested when determining the EPA, a brief explanation of why the EPA must contain an audience and all other information that the requested person would like to examine when determining the application;

(3) The signature of the person who submits the application, or, if the application is made on behalf of an organization or other body, the signature of a responsible employee of the organization or elsewhere.

In the event that a hearing is requested and granted, the EPA notifies the hearing in theFederal registrationAt least 15 days before the date of the planned hearing.The EPA can be rejected for the first year or inhumane hearing.If no timely application for hearing is received and granted, the EPA of the state of New Hampshir approves its part 142 - program for the implementation of national primary drinking water regulations so that the electronic report can enter effects for 30 days according to today's notification publicSection 3,1000 (f) (4).

The following represents the intellectual property that is to be licensed as part of the perspective contract:

(A) US preliminary patent requirement 62/006.313 with the title "Chimera antigen receptors on CD-19" [HHS Ref.E-042-2014-US-01], Patent PCT/US2015/033473 Patent request "Chimenary antigen receptors that aim at CD-19 ”[HHS Ref.E-042-2014-0-PCT-02], Australian patent 2015270912 entitled“ Chimerary Antigen receptors that are aimed at CD-19 ”[HHS Ref.E-042-2014-0-au-03], Canadian patent request 2951045 with the title "Chimera antigen receptors that are aimed at CD-19" [HHS Ref.E-042-2014-0-CA-04], Chinese patent request 201580033802.5With the title "Chimera antigen receptors that aim to CD-19" [HHS Ref.E-042-2014-0-CN-05], European Patent 3149044 with the title "Chimarian antigen receptors on CD-19" [HHS Ref.E-042-2014-0-EP-06] (Validated in Germany [HHS Ref. E-042-2014-0-de-19], Spain [HHS Ref., France [HHS Ref. E-042-2014- 0-Fr-21], Great Britain [HHS Ref. E-042-2014-0-GB-22], Italy [HHS Ref. -It-23] and Ireland [HHS Ref. E-042-2014-0-24] and in Hong Kong [E-042-2014-0-HK-16]) Israeli patent request 249305 entitled "Quimere Antigen receptors on CD-19" [HHS Ref.042-2014-0-07], Indian patent request 291647041047 entitled "Chimerary antigen receptors aimed at CD-19" [HHS Ref.E-042-2014-0-in-08], Japanese patent requirement 2016-571017 with thatTitle "Chimarian antigen receptors that are aimed at CD-19" [HHS Ref.E-042-2014-0-JP-09], South Korean patent request 2016-7036828 entitled "Chimer Antigen receptors Target CD-19" [HHS Ref.E-042-2014-0-Kr-10], Mexican patent requirement MX/A/2016/015834 with the title "Chimer antigen receptors Target CD-19" [HHS Ref.E-042-2014-0-MX-11],Patent request from New Zealand 727167 entitled "Chimerary antigen receptors aimed at CD-19" [HHS Ref.E-042-2014-0-NZ-12], patent request from Saudi Arabia 516380406 entitled "Chimer Antigen receptors target CD-CD19 “[HHS Ref.E-042-2014-0-SA-13], Singapore patent request 11201609960Q withthe title "Chimer antigen receptors that are aimed at CD-19" [HHS Ref.E-042-2014-0-SG-14], patent of the United States 10.287.350 with the title “Chimerary antigen receptors, which on CD-19target "[HHS Ref.E-042-2014-0-USA-15], US patent request 16/360.281 with the title" Chimerary antigen receptors that are aimed at CD-19 "[HHS Ref.E-042-2014-0-USA-17], Patent request from New Zealand 764530 with the title "Chimerary antigen receptors aimed at CD-19" [HHS Ref.E-042-2014-0-NZ-18], European patent request 20197459.9Antigen receptors on CD-19 ”[HHS Ref.E-042-2014-0-EP-25], Australian patent request 2020267211 entitled“ Chimarian antigen receptors that are aimed at CD-19 ”[HHS Ref.E-042-2014-0-au-26] and Japanese patent requirement XXX with the title "Chimerary antigen receptors aimed at CD-19" [HHS Ref.E-042-2014-0-JP-27] and all US and foreign patent patent/Requirements for the technology family.

Patent rights in these inventions were attributed to the United States government and/or only licensed.

The potential exclusive license area can be worldwide and the field of use can be limited to the following:

This technology reveals the development of chimeric antigen receptors that recognize the cell surface protein CD19. CD19 is expressed on the cell surface of several autoimmune disease cells including lupus nephritis. Many autoimmune diseases have no FDA-approved therapies, underscoring an unmet need. The development of a therapeutic for autoimmune diseases that targets CD19 will benefit public health by providing treatment to patients who may not have options.

This notice is given pursuant to 35 U.S.C. 209 and 37 CFR Part 404. The Prospective Exclusive License entails royalties and the Prospective Exclusive License may be granted unless written evidence and arguments are received by the National Cancer Institute within fifteen (15) days of the date of this announcement that the grant of the license does not comply with the requirements of 35 U.S.C. 209 and 37 CFR Part 404.

In response to this notice, the public may submit comments or objections. Comments and objections, other than those in the form of a completed License Application, will be non-confidential and may be made publicly available.

License orders submitted in response to this notice are believed to contain confidential business information, and disclosure of information in such license orders will be made only as necessary and upon request pursuant to the Freedom of Information Act, 5 U.S.C. 552.

Components of this request for information are:

1. List of Legal Providers for UAC in ORR Care (Form LRG-5/5s): This tool is provided to UAC by its case manager. The tool contains a list of legal service providers available to the UAC. The UAC will initial and sign the instrument upon admission and release from ORR custody to acknowledge receipt of the documents contained in the ORR Legal Resource Guide. This form was previously approved under OMB number 0970-0498 and will be reintroduced unchanged under this new OMB number.

2. Request for AFloresEasy Audicia (Form LRG-7/7S): This instrument is made available to the UAC placed by the case manager.The instrument is always the UAC in a restrictive environment (safe, safe, safe and protected treatment.FloresTitlePublikum.

3. Application for Secured Bail Request or Secured Custody Personnel (LRG-8A Form): This instrument is completed by case managers upon receipt of aRequest for flower titles hearinghanded over to a UAC in safe or personal custody and provided to the Orr.Orr submits the application to the local immigration court.

4. Application for Requesting a Title Hearing - Unsecured Custody (Form LRG-8B): This document is completed by case managers upon receipt of aRequest for flower titles hearingfor a UAC placed in an insecure program (FOR EXAMPLE,shelter, orphanage) and the ORR. ORR files the application with the local immigration court.

5. Juvenile Court Jurisdiction Specific Consent Request (Form L-1): This tool is used by legal service providers and registration attorneys to request specific consent from the ORR in cases where they seek Juvenile Special Immigrant Legal Protection for their UAC client and they are also tempted to invoke the jurisdiction of a state court to determine or change UAC's custody or placement status. This form is currently approved under OMB number 0970-0385 but has been revised and moved to this new OMB number which consists of related forms.

6. Summary of Request for Specific Consent (Form L-2): This document is completed by ORR Federal Field Specialists (FFS) when the ORR receives a request for specific consent. The FFS provide case information that allows the Director of the ORR to make an informed decision about granting specific consent.

7. Notification of Legal Representation (Form L-3): This document is completed by UAC prosecutors to notify the ORR of the purpose of legal representation and the duration of the representation. ORR uses this tool to ensure case updates are made available to attorneys. This tool can also be used by registration attorneys when requesting a copy of their clients' records.

8. UAC Legal Information (Form L-4): This tool is used by case managers to document referrals to the Human Trafficking Bureau, if necessary; Meetings between UAC and your legal service provider or registrar; the provision of the ORR Legal Resources Guide to the UAC; Information about the UAC legal service provider or attorney; immigration and administrative hearings; and provision ofNotice of placement in a restrictive environmentto UAC. The tool also includes an area for uploading legal documents.

9. Legal Services Register (Form L-6): This tool is used by case managers to create a register containing certain information and documents that the ORR makes available to ORR-funded legal services providers without the need for a formal request for records .

10. Relocation Request (Form L-7): This tool is used by case managers to file a relocation request when a UAC is transferred to a new immigration court jurisdiction or discharged.

11. Post-Legal Status Plan (Form L-8): This tool is used by case managers to create a plan for UAC and obtain approval from a Federal Field Specialist Supervisor who must obtain legal status to which ​At the time the UAC must be released from ORR custody.

Respondent:ORR grantee and contract staff; YOU ACCEPT; UAC Parent/Guardian; registration attorneys; and legal service providers.

Comments:In particular, the Department seeks comments on (a) whether the proposed collection of information is necessary for the proper performance of the Agency's tasks, including whether the information will be of practical use; (b) the accuracy of the Agency's estimated burden of the proposed information collection; (c) quality, usefulness and clarity of information to be collected; and (d) ways to minimize the burden of collecting information about respondents, including through the use of automated collection techniques or other forms of information technology. Comments and suggestions will be considered within 60 days of posting.

This notice provides a summary of the usage and effort associated with the following information collections. For more detailed information, see the accompanying statement of each collection and related materials (seeTHE ADDRESS).

PRA (44 USC 3501-3520) requires federal agencies to obtain approval from the Office of Management and Budget (OMB) for any information collection they conduct or sponsor. The term "information collection" is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and contains governmental requests or requirements for members of the public to file reports, keep records, or share information with third parties. Section 3506(c)(2)(A) of the PRA requires federal agencies to provide 60 days notice in theFederal registrationabout any proposed collection of information, including any proposed expansion or restoration of an existing collection of information, before the collection is submitted to the OMB for approval. To comply with this requirement, the CMS is publishing this notice.

1.Type of information collection request:restore without modification to a currently approved collection;Information collection title:Electronic submission of Medicare Graduate Medical Education (GME) affiliation agreements;To use:The regulations existing in § 413.75 (b) allow hospitals that share the residents, a group associated with Medicare GME if they are in the same or in coherent urban or rural areas if they are under common property or if they areAs they are as they are, are as program patrocinators or large institutions that share in the same program of the accreditation authority.In § 413.79 (f) (1) you state that every hospital of a group connected to Medicare GME Medicare (Mac) can send a copy to the centers for Medicare and Medicaid Services (CMS) untilFor the July 1st of the Medicare GME entry agreement.

CM also use these membership agreements as reference material if possible problems with specific affiliations.Although in the past we have printed copies of membership agreements used for the same purposes of membership agreements.Form number:CMS-10326 (OMB control number: 0938-1111);Frequency:Yearly;Affected public:private sector, corporation or other for-profit, not-for-profit entity;Number of respondents:125;Annual Total Responses:125;In totalannual hours:166. (For policy questions regarding this collection, please contact Shevi Marciano at 410-786-2875.)

According to the PRA (44 U.S.C. 1320.3 (c) and includes agency inquiries or requirements that public members send reports, manage records or deliver to third parties to third parties. 3506 (2) c) (2)) demands that the federal authorities60 days offer announcement in theFederal registrationWith regard to every collection of information proposals, including any proposed expansion of an existing information collection, before sending the collection to the OMB for approval.In order to meet this requirement, the FDA publishes a message from the proposed information collection specified in this document.

With respect to the following information collection, FDA requests comments on: (1) when the proposed information collection is necessary for the proper performance of FDA functions, including when the information is practical; (2) the accuracy of FDA's estimate of the proposed information collection, including the validity of the methodology and assumptions used; (3) ways to improve the quality, usefulness, and clarity of the information to be collected; and (4) ways to minimize the burden of collecting information about respondents including the use of automated collection techniques, where appropriate, and other forms of information technology.

This collection of information supports the agency's regulations. Section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360) requires any person who owns or operates a facility that manufactures, prepares, distributes, mixes, or processes a drug or device to register with the Department of Health and Human Services Resources Services, on or before December 31 of each year, among other information, its name, place of business and all such entities and must submit a list of all drug and device products manufactured, manufactured, distributed, assembled or processed by him or them for commercial distribution, among other information. In 21 CFR Part 607, the FDA issued regulations to implement these requirements for manufacturers of human blood and blood products.

The regulations establish procedures and requirements related to facility and product listing registrations for manufacturers of human blood and blood products and licensed devices, including initial registration, annual registration, product listing updates, and exemption requests. Owners or operators of certain facilities that manufacture blood products are required to register and provide a list of all blood products in commercial distribution (21 CFR 607.20(a)). Initial and subsequent registrations and product listings must be submitted electronically through the FDA Center for Biological Evaluation and Research (CBER) product registration and listing system.or any future electronic replacement system, unless the FDA has approved a request to waive this requirement prior to the information due date (21 CFR 607.22(a)). Waiver requests must be in writing and must include, among other information, specific reasons why electronic submission is unreasonable for the registrant (21 CFR 607.22(b)). Facility registration and product listing information assists the FDA in its facility inspections, among other things, and its collection is essential to the overall regulatory system designed to ensure the safety of the country's blood supply.

Description of the interviewees:Responses to this collection of information include human blood and plasma donation centers, blood banks, certain transfusion services, other blood product manufacturers, independent laboratories involved in quality control and testing for registered blood product establishments, and equipment manufacturers licensed under Section 351 of the Public Health Services Act.

We estimate the effort involved in collecting information as follows:

Based on our FiskAld data assessment of the 2019 Cber registration and product list system, we have adapted the currently approved load estimate that we attribute the registration and product list of the furnishing state to reflect a slight increase in the submissions.The general burden has not changed.

According to the PRA (44 U.S.C. 1320.3 (c) and includes agency inquiries or requirements that public members send reports, manage records or deliver to third parties to third parties. 3506 (2) c) (2)) demands that the federal authorities60 days offer announcement in theFederal registrationabout any proposed collection of information, including any proposed extension of an existing collection of information, before the collection is submitted to the OMB for approval. To meet this requirement, FDA is issuing a notice of the proposed information collection set forth in this document.

With respect to the following information collection, FDA requests comments on: (1) when the proposed information collection is necessary for the proper performance of FDA functions, including when the information is practical; (2) the accuracy of FDA's estimate of the proposed information collection, including the validity of the methodology and assumptions used; (3) ways to improve the quality, usefulness, and clarity of the information to be collected; and (4) ways to minimize the burden of collecting information about respondents including the use of automated collection techniques, where appropriate, and other forms of information technology.

From 1998 to 2008, the FDA's National Retail Food Team conducted a study to measure trends in the occurrence of risk factors for foodborne illness, preparation practices, and employee behaviors that were most commonly reported to the Centers for Disease Control and Prevention as risk factors of foodborne illness retail diseases. Specifically, data was collected from FDA experts at retail and foodservice establishments at 5-year intervals (1998, 2003, and 2008) to monitor and document trends in the incidence of the following risk factors for foodborne illness:

• food from unsafe sources,

• Poor personal hygiene,

• improper cooking,

• keeping/time and temperature inappropriate and

• Contaminated equipment/cross contamination.

FDA Developed Reports Summarizing the Findings for Each of the Three Data Collection Periods, Released in 2000, 2004 and 2009 (References 1 To 3).Data from the Three Data Collection Periods Were Analyzed to Detect Improvement Or Regression Trends Over Time and To Determine What progress has been made to reduce the occurrence of risk factors of food that through food in the selected types of retail and food (lit.4) were transferred.

Based on this 10-year research as a foundation from 2013 to 2014, the FDA started a new study period. This study covers 10 years. The FDA completed the collection of baseline data on select types of healthcare facilities, schools, and grocery stores in 2015 through 2016, and this data is being evaluated for trends and significance. A second data collection will be completed in 2019-2020 and will be completed when safe (pending Covid-19 pandemic) and an additional data collection is planned in 2023-2024 (subject of this information collection expansion). Therefore, data collections are required to trend data.

The results of this 10-year study period will be used to:

• Development of initiatives on nutritional security in retail, directed intervention guidelines and strategies that concentrate on the control of risk factors for diseases transmitted with food;

• Provision of technical support for state, local, tribal and territorial regulatory experts;

• Identify FDA retail work plan priorities and;

• Enter FDA resource allocation to improve retail food safety nationwide.

The legal basis for FDA conducting this study is the Public Health Service Act (PHS Act) (42 U.S.C. 243, Section 311(a)). Responsibility for enforcing the food safety provisions of the PHS Act was transferred to the Food and Drug Commissioner in 1968 (21 CFR 5.10(a)(2) and (4)). In addition, the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301The following is.) and the Economy Act (31 U.S.C. 1535) require the FDA to support other federal, state and local authorities.

The objectives of this study are:

• Identify less common risk factors for foodborne illness and food safety behaviors/practices at selected food retail establishments in the United States.

• Determine to what extent food safety management systems and the presence of a certified food safety manager influence the emergence of risk factors for foodborne diseases and food safety behaviours/practices; and

• Determine whether the occurrence of foodborne disease risk factors, food safety behaviors/practices in delicatessen shops differs depending on risk categorization and status of a facility as a single or multiple unit (FOR EXAMPLE,Establishments that are part of an establishment with two or more units).

The methodology to be used for this information collection is described below. In order to obtain a sufficient number of observations to perform statistically significant analyses, the FDA will conduct approximately 400 data collections at each facility type. This sample size was calculated to provide enough observations to be 95 percent confident that the percent agreement is within 5 percent of the true percent agreement.

A geographic information system database containing a listing of businesses in the United States provides the inventory of facilities for data collection. FDA samples existing facilities based on the descriptions in Table 1. The FDA does not intend to sample facilities that only handle prepackaged foods or conduct low-risk food preparation activities. The FDA Food Code provides a risk grouping of facilities based on the type of food preparation typically performed within the facility (Ref. 5). Businesses in risk classes 2 to 4 are intended.

The FDA has approximately 25 regional food retail experts (experts) who act as data collectors for the 10-year study. The specialists are geographically spread across the United States and have technical knowledge of retail food safety and a solid understanding of the operations in each of the types of establishments studied. The experts are also standardized by staff at the FDA Center for Food Safety and Applied Nutrition in the application and interpretation of the FDA Food Code (Ref. 5).

Sampling zones have been established to correspond to a 175 mile radius of an expert's residence. The sample will be selected at random from all eligible farms located within these sample zones. Specialists are usually located in large metropolitan areas (This is,population centers) in the contiguous United States. Population centers often contain a large concentration of the facilities that the FDA intends to sample. Sampling in the sampling zones within 175 miles of the experts' homes provides three benefits to the study:

1. Provides a cross-section of urban and rural areas for the selection of suitable establishments.

2. Represents a mix of small, medium and large regulators with jurisdiction over eligible entities.

3. Reduces night driving and hence travel costs incurred by the agency to collect data.

The sample for each data collection period is distributed evenly among the experts. Because participation in the industry study is voluntary and the status of each randomly selected facility is subject to change, surrogate facilities were selected for each expert for instances where the institutional food service, school, or grocery store is misclassified, closed, or otherwise unavailable, not can or want to participate.

Prior to conducting data collection, experts will contact the state or local jurisdiction that has jurisdiction to conduct retail food inspections for the selected company. The surveyor verifies with the jurisdiction that the facility has been properly classified and is in operation for the purposes of the study. The expert verifies that the selected facility is legally registered by the state or local regulator. If the selected institution is subject to a statutory period of notice, no data will be collected by the expert and a replacement institution will be used. The state or local regulator will be invited to accompany the expert in data collection.

A standard form is used by experts during any data acquisition.The form is divided into three sections: Section 1 -"Information about the setup";Section 2 -"Information about the supervisory authority";and Section 3 -"Risk factor for food transmitted with food.

Section 2 Information - "Regulatory Authority Information" is obtained during an interview with the director of the state or local jurisdiction program that has regulatory responsibility for conducting inspections for the selected facility. Section 3 consists of three parts: Part A through Tabulated expert observations on the behaviors and practices of food workers in controlling contamination, spread and survival of food safety risks; Part B to evaluate the food management system implemented by installation and Part C to evaluate the frequency and extent of food staff hand washing. Party information is gathered from the direct observations of experts on food worker behaviors and practices. little standard and poorly standardized and experts when experts are required in relation to procedure or practicefood safety. The information in Part B is collected by making direct observations and asking questions to installation management to obtain information on where the food facility is being developed and implemented that the management of food security is developed. by food workers. It is a question asked after completing Section 3, Part C of the form.

The FDA collects the following information associated with the identity of the establishment: name of the facility, address, city, state, postcode, municipality, industry segment and type of installation.not duplicated. Information in connection with the type of company, such as capacity and number of employees per shift, are also collected. The data is consolidated and reported in order not to show the identity of an institutions included in the study.

The FDA worked with the Food Protection and Defense Institute to develop a web -based platform on Foodshield to collect, store and analyze data for the retail risk factor. This platform is accessible to state, local, territorial and tribal regulatory jurisdictionto collect relevant data for your own risk factors. For data acquisition from 2015 to 2016, the FDA piloted the use of portable technology for collecting data on site during data collection. The tablets available for data collection were part of a broader FDA initiativeconcentrated on internal portable technology use purposes. The tablets for data acquisition showed several technical and logistical challenges and increased the time load associated with data acquisition compared to the manual input of the data acquisition. For these reasons, the FDA will be during the 10 -year study timeDo not include the use of portable technology in the subsequent data acquisition.

When a data collector is assigned to a specific operation, he carries out the data collection and enters the information into the web-based data platform. The interface supports manual data entry as well as the ability to enter information directly into the database using a web browser.

The payload for data collection from 2023 to 2024 is as follows. For each data collection, the following individuals are interviewed: (1) the person responsible for the selected entity (whether it is a health entity, school, or supermarket/grocery store); and (2) the program director (or a designated person) of the relevant regulatory authority. In order to provide the sufficient number of observations required for a statistically significant analysis of the data, the FDA has determined that 400 data collections are required in each of the three types of facilities. Therefore, the total number of responses is 2,400 (400 data collections x 3 types of institutions x 2 respondents per data collection).

The effort involved in completing Sections 1 and 3 of the form is specific to those responsible for selected institutions. The load includes the time it takes the worker to accompany the data collector during the on-site visit and to answer the data collector's questions. The burden associated with completing Section 2 of the form rests with the program directors (or nominees) of the relevant regulatory authorities. This fee includes the time it takes to answer questions from data collectors and is the same regardless of the installation type.

To calculate estimated hours per response, FDA uses the average duration of data collection for similar facility types during the 2008 FDA Risk Factor Study (Ref. 3) plus an additional 30 minutes (0.5 hours) for information related to Section 3, Part B of the mold. The FDA estimates that those responsible for the types of healthcare facilities, schools, and retail stores will need 150 minutes (2.5 hours), 120 minutes (2 hours), and 180 minutes (3 hours), respectively, to follow the data collectors as they fill it out sections 1 and 3 of the form. The FDA estimates that it will take the program director (or designated person) of the applicable regulatory agency 30 minutes (0.5 hour) to answer the questions on Section 2 of the form. This exposure estimate remains unchanged since the last data collection. Therefore, the estimated total burden for data collection in healthcare settings is 180 minutes (150 + 30) (3 hours), in schools 150 minutes (120 + 30) (2.5 hours) and in grocery retail 210 minutes (180 +30) (3, 5 hours).

Based on the number of refusals to participate in the baseline data collection from 2015 to 2016, we estimate a 2% refusal rate for data collections in the health facility, school, and grocery store types. Estimated time per non-responder is 5 minutes (0.08 hours) for the appropriate person to listenfor the purpose of the visit and issue a verbal refusal of entry.

The FDA estimates the effort involved in gathering this information as follows:

Based on a review of the information gathered since our last OMB approval request, we have not made any adjustments to our load estimate.

The following references are in the Docket Management Team (seeTHE ADDRESS) and are available for advice from Monday to Friday from 9 a.m. to 4 p.m.; they are also available electronically athttps://www.regulations.gov.The FDA verified the website addresses at the time of publication of this documentFederal registration , So,However, the websites are exposed to changes over time.

In accordance with section 10 (a) of the law of the Federal Advice Committee, 5 U.S.C.App.From the public health service, 42 U.S.C.299c.According to its legal mandate, the Council must advise the secretary of the Ministry of Health and Human Services and the director of AHRQ in connection with Ahrq behavior of its mission, including the provision of guidelines, advise (a) priorities for medical care (((((((((((((b) The area of health research, including the training and distribution of information about the quality of health care and (c) the role of the agency in the light of the private sector and the possibilities for private sector partnerships. The council consists of public membersSecretary was appointed and the ex-office members of the federal government defined in the approval legislation.

On Thursday, March 18, 2021, the board meeting will take place at 10:00 a.m. with the convening of the CEO and the approval of the previous summary of the board.The meeting begins with an update about the recent achievements of AHRQ in the areas of health system research, practice improvement, data and analysis and how to achieve organizational excellence.The agenda also includes a discussion about communication and the value of research in health systems, an update to the PCOR loyalty funds and a discussion about how the AHRQ can promote equal opportunities.The session ends at 2 p.m.The session is public.Information about how to access the meeting, as well as other meeting details, including information on how to make a public comment, can be found athttps://www.ahrq.gov/news/events/nac/.The final agenda will be available on the AHRQ website by Thursday, March 11, 2021.

The following represents the intellectual property that is to be licensed as part of the perspective contract:

(A) US Provisional Patent Application 62/006, 313 entitled "Chimeric Antigen Receptors Targeting CD-19" [HHS Ref. No.E-042-2014-0-US-01], PCT patent application PCT/US2015/033473 with the title "Chimeric Antigen Receptors Targeting CD-19" [HHS Ref. No.E-042-2014-0-PCT-02], Australian patent 2015270912 entitled "Chimeric Antigen Receptors Targeting CD-19" [HHS Ref. No.E-042-2014-0-AU-03], Canadian patent application 2951045 entitled "Chimeric Antigen Receptors Targeting CD-19" [HHS Ref. No.E-042-2014-0-CA-04], Chinese patent application 201580033802.5 with the title "Chimeric Antigen Receptors Targeting CD-19" [HHS Ref. No.E-042-2014-0-CN-05], European Patent 3149044 with the title "Chimeric Antigen Receptors Targeting CD-19" [HHS Ref. E-042-2014-0-EP-06] (validated in Germany [HHSRef. E-042-2014-0-de-19], Spain [HHS Ref. E-042-2014-0-es-20], France [HHS Ref. E-042-2014-0-Fr-21], United Kingdom [HHS Ref. E-042-2014-0-GB-22], Italy [HHS Ref. E-042-2014-0 -it-23] and Ireland [HHS Ref. E-042-2014-0-Ie-24] and submitted in Hong Kong [E-042-2014-0-HK-16]), Israeli patent application 249305 entitled "Chimerary antigen receptors aimed at CD-19" [HHS Ref. No.E-042-2014-0-il-07], Indian patent application 291647041047 entitled "Chimeric Antigen Receptors Targeting CD-19" [HHS Ref. No.E-042-2014-0-in-08], Japanese patent application 2016-571017 entitled "Chimeric Antigen Receptors Targeting CD-19" [HHS Ref. No.E-042-2014-0-JP-09], South Korean patent application 2016-7036828 entitled "Chimeric Antigen Receptors Targeting CD-19" [HHS Ref. No.E-042-2014-0-Kr-10], Mexican patent application MX/A/2016/015834 with the title "Chimeric Antigen Receptors Targeting CD-19" [HHS Ref. No.E-042-2014-0-MX-11], New Zealand patent application 727167 entitled "Chimeric Antigen Receptors Targeting CD-19" [HHS Ref. No.E-042-2014-0-NZ-12], Saudi Arabia patent application 516380406 entitled "Chimeric Antigen Receptors Targeting CD-19" [HHS Ref. No.E-042-2014-0-SA-13], Singapore patent application 11201609960Q entitled "Chimeric Antigen Receptors Targeting CD-19" [HHS Ref. No.E-042-2014-0-SG-14], US patent 10.287.350 entitled "Chimeric Antigen Receptors Targeting CD-19" [HHS Ref. No.E-042-2014-0-US-15], US patent application 16/360.281 entitled "Chimeric Antigen Receptors Targeting CD-19" [HHS Ref. No.E-042-2014-0-US-17], New Zealand patent application 764530 entitled "Chimeric Antigen Receptors Targeting CD-19" [HHS Ref. No.E-042-2014-0-NZ-18], European patent application 20197459.9 with the title "Chimeric Antigen Receptors Targeting CD-19" [HHS Ref. No.E-042-2014-0-EP-25], Australian patent application 2020267211 entitled "Chimeric Antigen Receptors Targeting CD-19" [HHS Ref. No.E-042-2014-0-au-26] and the Japanese patent application XXX entitled "Chimeric Antigen Receptors Targeting CD-19" [HHS Ref. No.E-042-2014-0-JP-27] and all US and foreign patents/patent applications for the technology family.

Patent rights in these inventions were attributed to the United States government and/or only licensed.

The potential exclusive license area can be worldwide and the field of use can be limited to the following:

This technology reveals the development of chimeric antigen receptors that recognize the cell surface protein CD19. CD19 is expressed on the cell surface of several autoimmune disease cells including lupus nephritis. Many autoimmune diseases have no FDA-approved therapies, underscoring an unmet need. The development of a therapeutic for autoimmune diseases that targets CD19 will benefit public health by providing treatment to patients who may not have options.

This notice is given pursuant to 35 U.S.C. 209 and 37 CFR Part 404. The Prospective Exclusive License entails royalties and the Prospective Exclusive License may be granted unless written evidence and arguments are received by the National Cancer Institute within fifteen (15) days of the date of this announcement that the grant of the license does not comply with the requirements of 35 U.S.C. 209 and 37 CFR Part 404.

In response to this notice, the public may submit comments or objections. Comments and objections, other than those in the form of a completed License Application, will be non-confidential and may be made publicly available.

License orders submitted in response to this notice are believed to contain confidential business information, and disclosure of information in such license orders will be made only as necessary and upon request pursuant to the Freedom of Information Act, 5 U.S.C. 552.

Compliant with 44 U.S.C. 3507, the FDA submitted the following proposal to the OMB to collect information for review and approval.

This collection of information supports the Agency's regulations and related guidance regarding accelerated programs for serious illnesses. The purpose of our regulations in 21 CFR Part 312 Subpart E is to establish procedures to expedite the development, evaluation, and commercialization of new therapies to treat people with life-threatening and seriously debilitating diseases, particularly when satisfactory alternative therapies do not exist. . . While regulatory safety and efficacy standards apply to all medicines, the many types of medicines they are subject to and the wide range of uses of these medicines require flexibility in applying the standards.

We have developed an industry guide entitled Accelerated Programs for Serious Conditions - Drugs and Biologics as a central source of information on FDA policies and procedures related to the followingAccelerated Major Disease Programs: (1) Fast Track status, (2) Breakthrough Therapy status, (3) Accelerated Approval, and (4) Priority Review status. The guidelines outline threshold criteria that apply generally to accelerated programs, including what constitutes serious illness, unmet medical need, and available therapy. The guidance addresses the applicability of accelerated programs for rare diseases, clarification of available therapies and additional details on possible manufacturing flexibility and product quality. It also clarifies the eligibility criteria for designating breakthrough therapies and provides examples of surrogate endpoints and intermediate clinical endpoints used to support accelerated approval.

A sponsor or applicant seeking Fast Track status must submit an application to us demonstrating that the drug: (1) is intended for a serious or life-threatening condition, and (2) has the potential to cause an uncovered to meet medical needs. We anticipate that most information in support of a designation application will be available in accordance with the existing requirements for preparing a New Drug Application (IND), New Drug Application (NDA) or Biological Marketing Authorization Application (BLA ) were collected. If this information has already been submitted to us, the information may be summarized in the Quick Order request. A request for designation may need to include additional information not otherwise required by law or regulation. For example, additional information may be required to show that a product has the potential to address an unmet medical need when there is an approved therapy for the serious or life-threatening condition being treated. This information may include clinical data, published reports, summaries of data and reports, and a list of references. The amount of information and discussion in a nomination request need not be extensive, but should be sufficient for a reviewer to assess whether the criteria for an expedited nomination have been met.

After we make a Fast Track designation, a sponsor or candidate may send a pre-meeting packet that may include additional information to support an application to participate in certain Fast Track programs. The pre-meeting pack provides background information for the meeting and is intended to support the intended goals of the meeting. As with the expedited application for designation, we believe most sponsors or applicants have collected this information to meet existing requirements for preparing an IND, an NDA, or a BLA. These may include descriptions of clinical safety and efficacy studies that were not conducted as part of an IND (for example.,Foreign studies) and information to support an accelerated approval request.

We have also developed the orientation document entitled "Accelerated programs for regenerative medicine therapies for serious conditions". Guide offer sponsors that in the development of regenerative medicine therapies for serious or life -threatening diseases, FDA recommendations for accelerated development and review of these therapiesThe orientation describes accelerated programs that are available for sponsors of regenerative medicine for serious or life -threatening diseases or conditions, including products that referred to as advanced regenerative therapies (the FDA is called "advanced regenerative medical therapy". The clinical development of therapiesThe regenerative medicine and opportunities for sponsors of regenerative medicine therapies interact with the review team of the biological evaluation and research center.

You can find orientation documents on our website inhttps://www.fda.gov/regulatory-information/search-fda-guidance-documentsAnd were published in 21 CFR 10.115 in accordance with our guidelines for proven procedures, which provide public comment at any time.

noFederal registrationEffective November 18, 2020 (85 FR 73487), we have issued a 60-day notice requesting public comment on the proposed intelligence gathering. No comments were received.

We estimate the effort involved in collecting this information as follows:

Based on a review of the information collection since our last OMB approval request, we have increased our load estimates by 389 answers and 35,325 hours. As is reflected in Table 1, we estimate that 70 respondents send 101 priority review requests every year. We have an average of 30 hoursTime to prepare such a request.

We estimate that 119 respondents will submit 156 innovative appointments annually and assume that an average of 70 hours will be needed to prepare such an application.

We estimate that 205 respondents submit 261 quick allocation requests annually and estimate that an average of 60 hours is required to prepare one such request.

Of the quick match requests made each year, we responded to approximately 224 requests from 392 respondents, and a pre-meeting packet was sent for each of those requests that were granted. Therefore, we assume an average load of 100 hours per respondent to prepare a preparation package.

Finally, we estimate that 33 respondents will submit 38 RMAT assignment requests and assume that it takes an average of 60 hours to complete one such request.

The United States is a party to the 1971 Convention on Psychotropic Substances (1971 Convention). Section 201(d)(2)(B) of the CSA (21 U.S.C. 811(d)(2)(B)) provides that if the United States is notified under Article 2 of the 1971 Convention, the CND proposes to When deciding whether to add a drug or other substance to any of the 1971 Convention lists, to transfer a drug or substance from one list to another, or to remove it from the lists, the Secretary of State must provide this information to the Secretary of Health and Human Services (Secretariat of HHS). The secretary of HHS then publishes a summary of this information in theFederal registrationand offer interested persons the opportunity to submit comments. The Secretary of HHS must then evaluate the proposal and make a recommendation to the Secretary of State, which will bind the US representative in discussions and negotiations regarding the proposal.

As detailed in the following paragraphs, the Secretary of State has received notification from the Secretary-General of the United Nations (the Secretary-General) of seven substances to be considered for control under the 1971 Convention. This notification reflects the recommendation of the WHO's 43rd Expert Committee on Drug Dependence (ECDD), which met in October 2020.Federal registrationOn August 4, 2020 (85 FR 47217), the FDA announced the revision of the WHO ECDD and invited interested individuals to submit information for WHO review.

The full text of the Secretary-General's communication is contained in Section II. Section 201(d)(2)(B) of the CSA requires that the Secretary of HHS, upon receipt of a notice proposing an appointment, issue a notice in theFederal registrationGive interested parties the opportunity to send information and comments on the proposed planning action.

The United States is also part of the Single Narcotic Convention of 1961 (1961 Convention). The Secretary of State received notice from the Secretary-General of a substance that should be considered for control under that convention. CSA does not require HHS to provide a summary of this information in the publishFederal registration🇧🇷Mum interested people to offer and influence the opportunity to send comments on the recommendations of the recommendations of medication as part of the 1961 convention, the notification of these substances is also includedFederal registrationnotice.The comments are shared with other responsible authorities in order to support the foreign minister in the formulation of the US position to control these substances.The HHS recommendations are not binding for the representative of the United States in discussions and negotiations on the proposed material control as part of the 1961 Convention.

The formal United Nations notice identifying drug substances and explaining the basis for classification recommendations is reproduced below (nonrelevant text removed):

Although the WHO has issued specific planning recommendations for each of the drugs, the CND is not obliged to follow the WHO recommendations. The options available to the CND for substances considered for control under the 1971 Convention include the following: (1) accept WHO recommendations; (2) accept the control recommendations but control the drug in a regimen different from that recommended; or (3) reject the Recommendations outright.

Isotonitazene (chemical name:N,N-Dietil-2-(2-(4-isopropoxibenzil)-5-nitro-1H-Benzimidazole-1-yl) Ethan-1-amin) is a strong synthetic opioid that is misused like other synthetic opioids.Its use has led to harmful effects, including positive identification in 49 deaths in the United States between August 2019 and April 2020. Data from the law enforcement agencies indicate that isotoitanes have appeared on the illegal drug market of the United States.

According to the National Forensic Laboratory Information System (NFLIS) database, there have been 53 isotonitazene encounters in the United States as of June 2020. There are no commercial or approved medicinal uses for Isotonitazene. On August 20, 2020, the Drug Enforcement Administration issued an order temporarily controlling isotoitazen as a Schedule I substance under the CSA. Therefore, additional ongoing controls are required to meet US obligations if isotonitazene is included in Schedule I of the 1961 Convention.

CUMYL-PEGACLONE is a synthetic cannabinoid sold online and used to mimic the biological effects of tetrahydrocannabinol (THC), the main psychoactive compound in marijuana. Research and clinical reports have shown that synthetic cannabinoids are applied to plant material to allow the material to be smoked while users attempt to get a euphoric, psychoactive high. Synthetic cannabinoids have been marketed under the guise of "herbal incense" and promoted by drug dealers as legal alternatives to marijuana. In vitro studies show that CUMYL-PEGALCONE binds to and activates the cannabinoid receptor. CUMYL-PEGALCONE is not found in the United States according to the NFLIS database as of January 14, 2021. There is no commercial or approved medicinal use for CUMYL-PEGALCONE and it is not a CSA controlled substance. Therefore, additional ongoing controls are required to meet US obligations when CUMYL-PEGALCONE is controlled under Schedule II of the 1971 Convention.

MDMB-4en-PINACA is a synthetic cannabinoid sold online and used to mimic the biological effects of THC, the main psychoactive ingredient in marijuana. Research and clinical reports have shown that synthetic cannabinoids are applied to plant material to allow the material to be smoked while users attempt to get a euphoric, psychoactive high. Synthetic cannabinoids have been marketed under the guise of "herbal incense" and promoted by drug dealers as legal alternatives to marijuana. According to the NFLIS database, MDMB-4en-PINACA was first found in the United States in January 2019. There have been 3,331 MDMB-4en-PINACA encounters in the United States as of January 14, 2021. MDMB-4en-PINACA has also been found mixed with opioids, including heroin and fentanyl, with some incidents leading to violence.behavior, tachycardia and hypertension. There are no commercial or approved medicinal uses for MDMB-4en-PINACA and it is not a CSA controlled substance. Therefore, additional ongoing controls are required to meet US obligations when controlling MDMB-4en-PINACA under Annex II of the 1971 Convention.

3-methoxyphencyclidine; Chemical Name: 1-(1-(3-Methoxyphenyl)cyclohexyl)piperidine) is a novel N-methyl-D-aspartate (NMDA) receptor antagonist with structural and biochemical similarities to phencyclidine (PCP) and other arylcyclohexylamines. 3-Methoxyphencyclidine is classified as an arylcyclohexylamine and produces dissociative anesthetic and hallucinogenic effects. Use of this substance has been linked to poisoning and published case reports of fatal and non-fatal overdoses. 3-Methoxyphencyclidine is found by police in drug crime reports. 3-Methoxyphencyclidine is an analogue of the hallucinogen Program II PCP. There is no approved medicinal use for 3-methoxyphencyclidine in the United States and it is not a CSA controlled substance. When 3-methoxyphencyclidine is intended for human consumption, it may be used under 21 U.S.C. 802(32)(A) and 813. Therefore, additional ongoing controls are required to meet US obligations when controlling 3-methoxyphencyclidine under Annex II of the 1971 Convention.

Diphenidine (chemical name: 1-(1,2-diphenylethyl)piperidine) is a non-competitive NMDA receptor antagonist classified as diarylylethylamine and has dissociative anesthetic and hallucinogenic effects. It was originally synthesized in the 1920s, but reports of abuse began in the last decade. Use of this substance has been associated with poisoning and with published case reports of fatal and nonfatal overdoses outside the United States. Diphenidine is found by police in drug crime reports. Diphenidine is not approved for medical use in the United States and is not a CSA controlled substance. Therefore, additional ongoing controls are required to meet US obligations when controlling diphenidine under Schedule II of the 1971 Convention.

Flubromazolam, clonazolam, and diclazepam belong to a class of drugs known as benzodiazepines. Benzodiazepines produce central nervous system depression and are commonly used to treat insomnia, anxiety, and seizures. Flubromazolam is a triazole analogue of the designer benzodiazepine flubromazepam. Flubromazolam can be purchased online and is used recreationally in the United States. Flubromazolam has been identified in an increasing number of arrests by police and has been linked to an increasing number of drug overdose deaths. According to the NFLIS database, there were 1,446 encounters with clonazolam in 2020 (as of December 2020). It is abused by a wide variety of groups, including adolescents, young adults, and older adults. Clonazolam alone and in combination with alcohol has been implicated in an increasing number of drug seizures and drug overdose deaths. The NFLIS database reported 249 encounters in 2020 (as of December 2020). Diclazepam is a designer benzodiazepine sold online and is most commonly found as a liquid solution, but can also be sold as a powder, tablet, blotting paper, or pellet. In 2020, the NFLIS database reported 113 encounters with diclazepam (as of December 2020). In 2018, flubromazolam, clonazolam, and dicalazepam were all identified by law enforcement agencies in drug-driving cases in the United States. Flubromazolam, clonazolam, and diclazepam are not approved for medical use in the United States and are not CSA controlled substances. Therefore, additional ongoing controls are required to meet US obligations when controlling flubromazolam, clonazolam and dicalazepam under Schedule IV of the 1971 Convention.

The FDA, on behalf of the Secretary of HHS, invites interested parties to comment on United Nations notifications related to these drugs. The FDA, in collaboration with the National Institute on Drug Abuse, will consider comments on behalf of the HHS when evaluating WHO planning recommendations. Then, pursuant to Section 201(d)(2)(B) of the CSA, HHS will recommend to the Secretary of State what position the United States should take in voting on the substance control recommendations under the 1971 Convention at the US Committee on CND in April 2021.

Comments on the WHO recommendations for the control of isotoitazene under the 1961 Single Convention are also being forwarded to the relevant authorities for consideration in the development of the US position on narcotics at the CND meeting.

Compliant with 44 U.S.C. 3507, the FDA submitted the following proposal to the OMB to collect information for review and approval.

The information required by Section 402(j)(5)(B) of the Public Health Service Act (PHS Act) (42 U.S.C. 282(j)(5)(B)) is submitted in the form of a certificate, Form FDA, 3674, which tracks applications and submissions currently submitted to the FDA and already approved by the OMB. The OMB Control Numbers and expiration dates for these orders and shipments are: 21 CFR Parts 312 and 314 (Medicines for Human Use), OMB Control Number 0910-0014, expires March 31, 2022, and OMB Control Number 0910-0001, expires March 31, 2022. March off. 2021; 21 CFR Parts 312 and 601 (Biologics), OMB control number 0910-0014, expiring March 31, 2022, and OMB control number 0910-0338, expiring February 28, 2023; 21 CFR Parts 807 and 814 (Equipment), OMB Control Number 0910-0120, Effective June 30, 2020, and OMB Control Number 0910-0231, Effective March 31, 2023.

Title VIII of the Food and Drug Administration Amendment Act of 2007 (FDAAA) (Pub. L. 110-85) amended the PHS Act by adding Section 402(j). The regulations expanded the scope of clinical trials subject to submission of information and required that additional information be submitted to the clinical trials database (https://clinicaltrials.gov/) (The FDA has verified the website address, but the FDA is not responsible for subsequent changes to the website after this document was publishedFederal registration) previously established by the National Institutes of Health (NIH)/National Library of Medicine. This includes extended information on applicable clinical trials and summary information on the results of specific clinical trials. The provisions include responsibilities to the FDA and various amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act).

One provision, Section 402(j)(5)(B) of the PHS Act, requires shipments of human drug, biologic and device products manufactured to the FDA to be accompanied by certification. Specifically, at the time of filing a request under Section 505, 515, or 520(m) of the FD&C Act (21 U.S.C. 355, 360e, or 360j(m)) or Section 351 of the PHS Act (42 U.S.C. 262 ) or filing a report under Section 510(k) of the FD&C Act (21 U.S.C. 360(k)), such request or submission must be accompanied by certification, FDA Form 3674, that all applicable requirements of Section 402(j) of the PHS Act have been met . When available, such certification must include the appropriate National Clinical Trial (NCT) numbers, which will be assigned after submission of the required information to the NIH database athttps://clinicaltrials.gov/.

The proposed scope of information collection is necessary to comply with the legal requirement above. The importance of obtaining this data relates to meeting regulatory requirements for submissions to the Clinical Trials Registry and Results Database and ensuring that individuals and organizations submitting inquiries or reports to the FDA comply with the listed provisions of the FD&C Act or the PHS Act that meet appropriate legal and regulatory requirements to certify compliance with those requirements. Failure to provide the certification required by Section 402(j)(5)(B) of the PHS Act and knowingly submitting a false certification are prohibited under Section 301 of the FD&C Act (21 U.S.C. 331). Violations will be punished with civil penalties. FDA Form 3674 provides a convenient mechanism for sponsors/applicants/submitters to meet regulatory certification requirements.

To help sponsors/applicants/submitters understand the regulatory requirements associated with FDA Form 3674, we have provided guidance available at:https://www.fda.gov/RegulatoryInformation/Guidances/ucm125335.htm🇧🇷 This guidance recommends that FDA-reviewed applications and submissions include the certification form, FDA Form 3674. The applications and submissions identified in the guideline are reflected in the stress analysis. The FDA last updated these guidelines in 2017.

investigational applications of new drugs. The FDA's Center for Drug Evaluation and Research (CDER) received 1,661 new investigational drug applications (INDs) and 11,328 IND amendments to clinical protocols in calendar year (CY) 2019. of clinical protocols and IND will remain at or near these levels for the foreseeable future.

The FDA Center for Biological Evaluation and Research (CBER) received 639 new INDs and 581 IND clinical protocol changes in fiscal year 2019. a near future. The estimated total number of submissions (new INDs and newProtocol submissions) subject to mandatory certification requirements under Section 402(j)(5)(B) of the PHS Act is 12,989 for CDER plus 1,220 for CBER or 14,209 submissions per year. Minutes per Response is the estimated number of minutes a respondent would spend preparing information to be submitted to the FDA under Section 402(j)(5)(B) of the PHS Act, including the time required to enter the required information in the form .

Based on its experience with current filings, the FDA estimates that it would take an average of about 15 minutes per response for certifications accompanying IND applications and clinical protocol change submissions. It is expected that most research request submissions relate to only a few protocols for which the sponsor/applicant/submitter has received an NCT number fromhttps://clinicaltrials.gov/prior to submission to the FDA. It is also assumed that the sponsor/applicant/submitter has electronic resources that allow them to retrieve the information needed to efficiently complete the form.

Applications/submissions for marketing. In fiscal year 2019, CDER and CBER received 252 New Drug Submissions (NDA)/Biologics Marketing Authorization Applications (BLA)/Pre-Marketing Authorizations (PMA)/Resubmissions and 701 NDA/BLA Amendments requiring certifications. CDER and CBER received 295 efficacy supplements/resubmissions for previously approved NDAs/BLAs in fiscal year 2019. CDER and CBER received 893 Abbreviated New Drug Applications (ANDAs) in fiscal year 2019. CDER received 765 bioequivalence amendments/amendments in fiscal year 2019. CDER and CBER expect new drug/biologic applications/resubmissions and submission rates for dietary supplement efficacy to remain at or near these levels for the foreseeable future.

The FDA's Center for Devices and Radiological Health (CDRH) received a total of 324 new PMA applications, 510(k) clinical information submissions, PMA supplements, Humane Device Exemption (HDE) applications, and amendment applications in fiscal 2019. CDRH expects that order, amendment, supplement, and annual reporting fees will remain at or near these levels for the foreseeable future.

Based on their experience reviewing NDAs, BLAs, PMAs, HDEs, 510(k)s and ANDAs and experience with recent FDA Form 3674 submissions, the FDA estimates that it takes an average of about 45 minutes per response for companion certifications would. the NDA, BLA, PMA, HDE, 510(k) and ANDA marketing filings and applications. It is assumed that the sponsor/applicant/submitter has electronic resources that allow them to retrieve the information needed to efficiently complete the form.

noFederal registrationOn May 14, 2020 (85 FR 28955), the FDA issued a 60-day notice requesting public comment on the proposed information collection. No comments were received.

The FDA estimates the effort involved in gathering this information as follows:

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for any information collection they conduct or sponsor. The term "information collection" is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and contains governmental requests or requirements for members of the public to file reports, keep records, or share information with third parties. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to provide a 30-day notice imFederal registrationabout any proposed collection of information, including any proposed expansion or restoration of an existing collection of information, before the collection is submitted to the OMB for approval. To comply with this requirement, CMS is issuing this notice, which summarizes the following proposed collection(s) of information for public comment:

1.Type of information collection request:New Fee (Application for New OMB Control Number);Information collection title:Data Management Plan Self-Assessment Questionnaire (DMP SAQ);To use:The Privacy Act 1974 permits the arbitrary disclosure of data stored in recording systems protected by the Privacy Act under Section 552a(b) (Disclosure Conditions). The mandate to account for data disclosures under the Data Protection Act is found in Section 552a(c) (Accounting for Certain Disclosures). This section establishes that certain information about the disclosures made by each agency must be retained. This information is: date, type, purpose and name/address of recipient. Section 552a(e) ​​​​​​defines general regulatory requirements that any authority must meet in order to keep records under data protection law. The Data Use Agreement (DUA) form is required as part of the review of every CMS data request to ensure compliance with data protection law requirements for disclosures involving PII.

The DUA legally binds the user to the terms of the agreement. User must agree to and sign all terms before sharing or accessing files containing protected health information and unique identifiers. The DMP SAQ is an evidence-based technical questionnaire that DUA users must complete as part of the data request package. The DMP SAQ allows the CMS to assess the researcher's data systems to ensure that the CMS data is adequately protected and protected in accordance with the Data Protection Act and the HIPAA Privacy Rule. The DMP SAQ also enables CMS to measure compliance through the implementation of security and privacy controls, as detailed in the National Institute of Standards and Technology (NIST) and Centers for Medicare and Medicaid Services (CMS) Special Publication 800-53 information Security and described Acceptable Risk Safeguards (ARS). The second component of the DMP SAQ is continuous monitoring. All organizations undergo routine audits of the environments used to store and process CMS data, as outlined in their organization-level DMP-SAQ.Form number:CMS-10733 (OMB Control Number: 0938-Neu);Frequency:Yearly;Affected public:Private sector, state, local or tribal government, federal government, corporations or other for-profit, not-for-profit entities;Number of respondents:1.000;Annual Total Responses:1.000;Total annual hours:1,500 (If you have any questions regarding policies regarding this collection, please contact James Krometis at 410-786-0340.)

The following is a list of FDA information collections recently approved by the OMB under Section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB Control Number and OMB Authorization Expiration Date for each information collection are listed in Table 1. Copies of the supporting statements for the information collections are available on the web athttps://www.reginfo.gov/public/do/PRAMain.An agency may not undertake or sponsor any collection of information, and an individual is under no obligation to respond unless they provide a currently valid OMB tracking number.

According to 41 CFR 102-3.65 and approval by the Department of Health and Human Services in accordance with 45 CFR part 11 and the General Services Administration, the FDA announces the renewal of the committee.The committee is an advisory Federal Committee without discretion that has been set up to advise the representative.

The Commissioner is responsible for administering the Radiation Control for Health and Safety Act 1968. This Act creates the Committee and requires the Commissioner to consult the Committee before prescribing standards for radiated emissions from electronic products. This committee shall advise the Commissioner on the technical feasibility, adequacy and practicability of performance standards for electronic products to control the radiated emissions of such products and may recommend radiation safety standards for electronic products for the Commissioner to consider.

The Committee consists of 15 voting members, including the President. The members and the chair shall be selected by the delegate or representative from authorities with knowledge in the fields of science or technology relevant to the radiation safety of electronic products. Members are invited to serve for overlapping terms of up to 4 years. Voting members include five members selected from government agencies, including state and federal governments, five members from affected industries and five members from the general public, at least one of whom must be a representative of organized labor. A quorum must consist of 10 members, of which at least 3 must be from the general public, 3 from government agencies and 3 from affected industries.

For more information on the latest writing and more information, please visithttps://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Radiation-EmittingProducts/TechnicalElectronicProductRadiationSafetyStandardsCommittee/default.htmor by contacting the designated federal official (seeCONTACT US FOR FURTHER INFORMATION🇧🇷 As no changes were made to the committee's name or job description, no changes will be made to 21 CFR 14.100.

This notice is issued pursuant to the Federal Advisory Committee Act (5 U.S.C. app.). For general information on FDA advisory committees, go tohttps://www.fda.gov/AdvisoryCommittees/default.htm.

According to the PRA (44 U.S.C. 1320.3 (c) and includes agency inquiries or requirements that public members send reports, manage records or deliver to third parties to third parties. 3506 (2) c) (2)) demands that the federal authorities60 days offer announcement in theFederal registrationWith regard to every collection of information proposals, including any proposed expansion of an existing information collection, before sending the collection to the OMB for approval.In order to meet this requirement, the FDA publishes a message from the proposed information collection specified in this document.

With respect to the following information collection, FDA requests comments on: (1) when the proposed information collection is necessary for the proper performance of FDA functions, including when the information is practical; (2) the accuracy of FDA's estimate of the proposed information collection, including the validity of the methodology and assumptions used; (3) ways to improve the quality, usefulness, and clarity of the information to be collected; and (4) ways to minimize the burden of collecting information about respondents including the use of automated collection techniques, where appropriate, and other forms of information technology.

This collection of information supports the agency's regulations. Under the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the FDA may establish specific controls, including performance standards, post-marketing surveillance, patient records, policies, and other appropriate actions it deems necessary to provide reasonable assurance of the Safety and effectiveness of the device. The special control instructions serve as a special control for the automatic blood cell separator, which uses the centrifugation or filtration principle and is intended for routine collection of blood and blood components (§ 864.9245 (21 CFR 864.9245)). The guidance, entitled Guidance for Industry and FDA Officials—Guidance Document for Class II Special Controls: Automated Blood Cell Separator Device Operating on Centrifugal or Filter Separation Principle, is available athttps://www.fda.gov/media/124263/download.

For currently marketed devices that fail the premarket approval process, the manufacturer must provide the FDA with an annual report for 3 consecutive years on the anniversary of the device's reclassification from Class III to Class II or on the anniversary of the Federal Food Agency's 510(k), Drug,and Cosmetic Act (FD&C Act) (21 U.S.C. 360(k)). Any subsequent device changes that require prior notification under Section 510(k) of the FD&C Rules must be included in the annual report. In addition, a manufacturer of a device that is considered substantially equivalent to an automated centrifugation- or filtration-based cell separator device intended for routine collection of blood and blood components must adhere to the same general and specific controls.

The annual report must include at least a summary of expected and unanticipated adverse events that have occurred and are not required to be reported by manufacturers under Medical Device Reporting (MDR) (Part 803 (21 CFR Part 803)). Reporting device adverse events, summarized in an annual report, alerts the FDA to trends or clusters of events that may pose a safety issue that would otherwise not be reported under the MDR regulation. The report must also include any subsequent changes to the Class III Prior Amendment determination that require 30 days notice under 21 CFR 814.39(f).

The reclassification of this device from Class III to Class II relieves manufacturers of the burden of meeting premarket approval requirements under Section 515 of the FD&C Act (21 U.S.C. 360e) and may allow smaller potential competitors to enter the market by reducing the burden is reduced . Although the Special Control Guidance recommends that manufacturers of these devices submit an annual report to the FDA for 3 consecutive years, this would be less onerous than the current post-approval requirements of 21 CFR Part 814 Subpart E, including periodic reporting under 21 CFR 814.84.

Collection or transfusion facilities, intended device users, and device manufacturers have specific responsibilities under federal regulations. For example, collection or transfusion facilities are required to keep records of all reports of adverse reaction claims (21 CFR 606.170), while the device manufacturer is responsible for conducting an investigation of any event of which the manufacturer is reasonably aware and evaluating the cause of the event ( §803.50(b) (21 CFR 803.50(b)) Additionally, medical device manufacturers are required to file reports of individual adverse events, such as death, serious injury, and malfunction, with the FDA (§803.50).

In the Special Control Guidance document, the FDA recommends that manufacturers include in their triennial reports a summary of adverse events maintained by the collection or transfusion facility or similar reports of adverse events collected.

The FDA estimates the effort involved in gathering this information as follows:

Based on FDA records, there are approximately three manufacturers of automated blood cell sorting equipment. We estimate that manufacturers spend around 5 hours preparing and submitting the annual report. Based on a review of the information gathered since our last OMB approval request, we have not made any adjustments to our fee estimates.

Other overload hours required by Section 864.9245 are reported and approved under OMB Control Number 0910-0120 (Premarket Notice Submission 510(k), 21 CFR Part 807, Subpart E) and OMB Control Number 0910-0437 (MDR, Part 803).

The Federal Emergency Management Agency (FEMA) is hereby notified that FEMA has appointed Vincent J. Maykovich as the Federal Coordinating Officer for this disaster pursuant to the authority conferred on the Administrator under Executive Order 12148, as amended.

This action ends the appointment of Michael F. O'Hare as the Federal Coordinating Officer for this disaster.

This notice is based on the authority of the Paperwork Reduction Act 1995; 44 USC Chapter 35, as amended. An ICR is a request to OIRA seeking approval, expansion or renewal of a collection of Coast Guard information (collection). The ICR contains information describing the purpose of the collection, the anticipated burden of the collection on the affected public, an explanation of the need for the collection, and other important information describing the collection. There is an ICR for each collection.

The Coast Guard is seeking comment on whether this ICR should be granted on the basis that collection is necessary for the proper performance of the department's duties. In particular, the Coast Guard would like to receive comments on: (1) the practical usefulness of the collection; (2) the accuracy of the estimated collection fee; (3) ways to improve the quality, usefulness, and clarity of the information underlying the collection; and (4) ways to minimize the burden of collection on respondents, including the use of automated collection techniques or other forms of information technology.

In response to your comments, we may revise this ICR or decide not to seek an extension of the collection permit. We will consider all comments and materials received during the comment period.

We encourage you to respond to this request by submitting comments and related materials. Comments must include the ICR-OMB control number and the protocol number of this application [USCG-2021-0043] and be received by April 19, 2021.

We encourage you to submit comments through the Federal eRulemaking Portal athttps://www.regulations.gov.If your material cannot be submittedhttps://www.regulations.gov,contact the person belowCONTACT US FOR FURTHER INFORMATIONSection of this document for alternative instructions. Documents referenced in this release and all public comments are located in our online archive athttps://www.regulations.govand can be viewed by following the instructions on this website. Additionally, if you access the online newsletter and sign up for email alerts, you will be notified when comments are posted.

We accept anonymous comments. All comments received will be posted tohttps://www.regulations.govand includes any personal information you provide. For more information on privacy and filings in response to this document, see the DHS eRulemaking System of Records Notice (85 FR 14226, March 11, 2020).

Title:Safety approval for freight containers.

OMB Control Number:1625-0024.

Summary:This collection of information comes with requirements for freight container owners and manufacturers to submit information and maintain records associated with the approval and inspection of those containers. This information is required to comply with the International Convention for Safe Containers (CSC), 29 U.S.T. 3707; T.I.A.S. 9037.

To need:This collection of information addresses the reporting and record keeping requirements for containers in 49 CFR Parts 450 through 453. These rules are necessary because the US is a signatory to the CSC. The CSC requires all containers to be safety checked prior to commercial use. These rules only dictate the minimum requirements of the CSC.

To form:none.

Respondent:Container owners and manufacturers and organizations delegated by the Coast Guard as approval authority.

Frequency:On occasion.

Estimated Credit Hours:The estimated usage increased from 117,271 hours to 129,345 hours per year due to the increase in the estimated annual number of calls.

Authority:The 1995 Bureaucracy Reduction Act; 44 USC Chapter 35, as amended.

The Federal Emergency Management Agency (FEMA) is pleased to announce that Paul F. Ford has been appointed Federal Coordinating Officer for this disaster by FEMA pursuant to the authority of Administrator under Executive Order 12148, as amended.

This action ends the appointment of W. Russell Webster as Federal Director of Coordination for this disaster.

The Federal Emergency Management Agency (FEMA) is pleased to announce that FEMA has appointed Kathy Fields as the Federal Coordinating Officer for this disaster pursuant to the authority conferred on the Administrator under Executive Order 12148, as amended.

This action ends the appointment of Paul Taylor as the Federal Coordinating Officer for this disaster.

The Federal Emergency Management Agency (FEMA) is pleased to announce that Tammy L. Littrell has been appointed by FEMA as Federal Coordinating Officer for this disaster pursuant to the authority conferred on the Administrator under Executive Order 12148, as amended.

This action ends the appointment of Robert J. Fenton as the Federal Coordinating Officer for this disaster.

The Federal Emergency Management Agency (FEMA) reports that under the authority it has been delegatedTammy L. Littrell of FEMA has been appointed Federal Coordinating Officer for this disaster under Executive Order 12148, as amended.

This action ends the appointment of Robert J. Fenton as the Federal Coordinating Officer for this disaster.

The notice of a major disaster declaration for the state of Alabama is amended to state that the following area is among the areas affected by the event covered by the President's May 20 statement:

The Federal Emergency Management Agency (FEMA) is pleased to announce that FEMA has appointed Kathy Fields as the Federal Coordinating Officer for this disaster pursuant to the authority conferred on the Administrator under Executive Order 12148, as amended.

This action ends the appointment of Paul Taylor as the Federal Coordinating Officer for this disaster.

The announcement of a major disaster declaration for the state of Oregon is amended to include the following area among those affected by the event covered by the President's May 15 statement.

The Federal Emergency Management Agency (FEMA) is pleased to announce that FEMA has appointed Janice P. Barlow as Federal Coordinating Officer for this disaster pursuant to the authority conferred on the Administrator under Executive Order 12148, as amended.

This action ends the appointment of MaryAnn Tierney as Federal Coordinating Officer for this disaster.

The Federal Emergency Management Agency (FEMA) is pleased to announce that Paul F. Ford has been appointed Federal Coordinating Officer for this disaster by FEMA pursuant to the authority of Administrator under Executive Order 12148, as amended.

This action ends the appointment of W. Russell Webster as Federal Director of Coordination for this disaster.

The Federal Emergency Management Agency (FEMA) is pleased to announce that Paul F. Ford has been appointed Federal Coordinating Officer for this disaster by FEMA pursuant to the authority of Administrator under Executive Order 12148, as amended.

This action ends the appointment of W. Russell Webster as Federal Director of Coordination for this disaster.

CBP invites the general public and other federal agencies to submit comments on proposed and/or continued collections of information under the Bureaucracy Reduction Act of 1995 (44 U.S.C. 3501The following is.🇧🇷 This process is performed in accordance with 5 CFR 1320.8. Written comments and suggestions from the public and concerned authorities should address one or more of the following four issues: (1) Whether the proposed collection of information is necessary for the proper performance of the authority's tasks, including whether the information will have practical benefits ; (2) the accuracy of the Agency's estimate of the effort involved in the proposed information collection, including the validity of the methodology and assumptions used; (3) suggestions for improving the quality, usefulness, and clarity of information to be collected; and (4) suggestions for minimizing the information collection burden on those who must respond, including through the use of appropriate automated, electronic, mechanical or other technological collection techniques or other forms of information technology,for example.,Enabling electronic submission of responses. Submitted comments will be summarized and included in the approval request. All comments will be made public.

Title:Stakeholder Scheduling Application.

WBO Number:1651-NOVO.

Current actions:Novo.

Rating type:Novo.

Affected public:individuals and companies.

Abstract:The Stakeholder Scheduling feature is a mobile application within the CBP OneMT' app that will standardize and automate the manual process of agents and travelers making and updating appointments with CBP for various services. Currently, Customs and Border Protection Officers (CBPOs) and CBP Agricultural Specialists (CBPAS) spend significant time exchanging phone calls, faxes and emails with interested parties to schedule inspection services. This includes inspections of perishable cargo, non-perishable cargo identified as a mandatory inspection, commercial or private airlines and commercial ship arrivals. Based on the security clearance, CBP advises interested parties that certain shipments must be scanned by CBP's non-contact inspection technology prior to release. The stakeholders then agree with CBP on a time and place to conduct the scans. Pilots and other interested parties contact CBP to arrange a time and place for inspections of commercial and private carriers (including occupants) or commercial vessels arriving from abroad. In addition, travelers transporting sensitive agricultural products by plane tell CBP that an arrival inspection is required.

The following CBP legal authorities permit the collection of this information: Intelligence Reform and Terrorism Prevention Act of 2004 (IRTPA), Public Law 108-458, 118 Stat. 3638; Immigration and Nationality Act, codified in 8 U.S.C. 1185 and 1354; Aviation and Transport Safety Act 2001 (ATSA); Enhanced Border Security and Visa Reform Act of 2002; and Tariff Act of 1930, as amended, 19 U.S.C. 66, 1433, 1459, 1485, 1624 and 2071.

Estimated number of respondents:2.000.

Estimated number of annual responses per respondent:127.

Estimated total annual responses:254.000.

Estimated Response Time:2 minutes.

Estimated total annual charging hours:8.467.

The notice of a major disaster declaration for the state of North Carolina is amended to include the following area among the areas to be adversely affected by the event declared a major disaster by the President in his October 14, 2020 declaration were classified as affected.

The Federal Emergency Management Agency (FEMA) is pleased to announce that FEMA has appointed Janice P. Barlow as Federal Coordinating Officer for this disaster pursuant to the authority conferred on the Administrator under Executive Order 12148, as amended.

This action ends the appointment of MaryAnn Tierney as Federal Coordinating Officer for this disaster.

The announcement of a major disaster declaration for the state of Oklahoma is amended to include the following areas among those determined to be affected by the event described by the President in his May 21 statement:

The Federal Emergency Management Agency (FEMA) gives notice that, pursuant to the authority conferred on the Administrator under Executive Order 12148, as amended, Paul F. Ford ofFEMA was appointed to serve as the federal coordinating officer for this disaster.

This action ends the appointment of W. Russell Webster as Federal Director of Coordination for this disaster.

Notice is hereby given that by letter dated January 12, 2021, the President issued a Major Disaster Declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121The following is.(the “Stafford Law”), as follows:

The required period of time for implementation of Section 310(a), Priority for Certain Requests for Public Facilities and Public Housing Assistance, 42 U.S.C. 5153, is valid for a maximum period of six months from the date of this declaration.

The Federal Emergency Management Agency (FEMA) is pleased to announce that FEMA has appointed John E. Long as the Federal Coordinating Officer for this major disaster pursuant to the authority of Administrator under Executive Order 12148, as amended.

The following areas in the state of Louisiana have been designated as affected by this major disaster:

Notice is hereby given that by letter dated January 12, 2021, the President issued a Major Disaster Declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121The following is.(the “Stafford Law”), as follows:

The Federal Emergency Management Agency (FEMA) is pleased to announce that Leda Khoury has been appointed by FEMA as Federal Coordinating Officer for this major disaster in accordance with the powers delegated to the Administrator under Executive Order 12148, as amended.

The Federal Emergency Management Agency (FEMA) is pleased to announce that Nancy J. Dragani has been appointed by FEMA as the Federal Coordinating Officer for this disaster pursuant to the authority of Administrator under Executive Order 12148, as amended.

This action ends the appointment of Lee K. dePalo as the Federal Coordinating Officer for this disaster.

This notice is based on the authority of the Paperwork Reduction Act 1995; 44 USC Chapter 35, as amended. An ICR is a request to OIRA seeking approval, expansion or renewal of a collection of Coast Guard information (collection). The ICR containsInformation describing the purpose of the collection, the likely burden of the collection on the affected public, an explanation of the need for the collection, and other important information describing the collection. There is an ICR for each collection.

The Coast Guard is seeking comment on whether this ICR should be granted on the basis that collection is necessary for the proper performance of the department's duties. In particular, the Coast Guard would like to receive comments on: (1) the practical usefulness of the collection; (2) the accuracy of the estimated collection fee; (3) ways to improve the quality, usefulness, and clarity of the information underlying the collection; and (4) ways to minimize the burden of collection on respondents, including the use of automated collection techniques or other forms of information technology.

In response to your comments, we may revise this ICR or decide not to seek an extension of the collection permit. We will consider all comments and materials received during the comment period.

We encourage you to respond to this request by submitting comments and related materials. Comments must include the ICR-OMB control number and the protocol number of this application [USCG-2021-0046] and be received by April 19, 2021.

We encourage you to submit comments through the Federal eRulemaking Portal athttps://www.regulations.gov.If your material cannot be submittedhttps://www.regulations.gov,contact the person belowCONTACT US FOR FURTHER INFORMATIONSection of this document for alternative instructions. Documents referenced in this release and all public comments are located in our online archive athttps://www.regulations.govand can be viewed by following the instructions on this website. Additionally, if you access the online newsletter and sign up for email alerts, you will be notified when comments are posted.

We accept anonymous comments. All comments received will be posted tohttps://www.regulations.govand includes any personal information you provide. For more information on privacy and filings in response to this document, see the DHS eRulemaking System of Records Notice (85 FR 14226, March 11, 2020).

Title:Safety regulations for ships in the commercial fishing industry.

OMB Control Number:1625-0061.

Summary:This collection of information is intended to improve safety on board vessels in the commercial fishing industry. The requirements apply to these ships and the seafarers on board.

To need:Under the authority of 46 U.S.C. 6104, the US Coast Guard issued regulations under 46 CFR Part 28 to reduce fatalities and accidents in the commercial fishing industry. The regulations allowing collection also provide a means of verifying compliance and improving the safe operation of fishing vessels.

To form:none.

Respondent:Owners, agents, responsible for commercial fishing vessels and insurance companies.

Frequency:On occasion.

Estimated Credit Hours:The estimated exposure remains at 4,832 hours per year.

Authority:The 1995 Bureaucracy Reduction Act; 44 USC Chapter 35, as amended.

The Federal Emergency Management Agency (FEMA) is pleased to announce that Nancy J. Dragani has been appointed by FEMA as the Federal Coordinating Officer for this disaster pursuant to the authority of Administrator under Executive Order 12148, as amended.

This action ends the appointment of Lee K. dePalo as the Federal Coordinating Officer for this disaster.

The Federal Emergency Management Agency (FEMA) is pleased to announce that FEMA has appointed Janice P. Barlow as Federal Coordinating Officer for this disaster pursuant to the authority conferred on the Administrator under Executive Order 12148, as amended.

This action ends the appointment of MaryAnn Tierney as Federal Coordinating Officer for this disaster.

The Federal Emergency Management Agency (FEMA) is pleased to announce that Kevin A. Wallace has been appointed Federal Coordinating Officer for this disaster by FEMA pursuant to authority conferred on the Administrator under Executive Order 12148, as amended.

This action ends the appointment of Jeffrey L. Coleman as Federal Director of Coordination for this disaster.

Notice is hereby given that by letter dated January 15, 2021, the President issued a Major Disaster Declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121The following is.(the “Stafford Law”), as follows:

The Federal Emergency Management Agency (FEMA) is pleased to announce that Jon K. Huss has been appointed by FEMA as the Federal Coordinating Officer for this major disaster pursuant to the authority conferred on the Administrator under Executive Order 12148, as amended.

The following areas in the state of Colorado have been designated as adversely affected by this major disaster:

Notice is hereby given that by letter dated January 12, 2021, the President issued a Major Disaster Declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121The following is.(the “Stafford Law”), as follows:

The Federal Emergency Management Agency (FEMA) is pleased to announce that Kenneth G. Clark has been appointed by FEMA as the Federal Coordinating Officer for this major disaster pursuant to the authority conferred on the Administrator under Executive Order 12148, as amended.

The following areas in the state of Utah have been designated as adversely affected by this major disaster:

Notice is hereby given that by letter dated January 11, 2021, the President issued an emergency declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as follows:

The Federal Emergency Management Agency (FEMA) announces that Thomas J. Fargione has been appointed Federal Coordinating Officer by FEMA pursuant to the authority of the Administrator of the Department of Homeland Security under Executive Order 12148, as amended, to declare a state of emergency.

The following areas of the District of Columbia have been designated as adversely affected by this declared emergency:

The Federal Emergency Management Agency (FEMA) is pleased to announce that Nancy J. Dragani has been appointed by FEMA as the Federal Coordinating Officer for this disaster pursuant to the authority of Administrator under Executive Order 12148, as amended.

This action ends the appointment of Lee K. dePalo as the Federal Coordinating Officer for this disaster.

The Federal Emergency Management Agency (FEMA) is pleased to announce that Tammy L. Littrell has been appointed by FEMA as Federal Coordinating Officer for this disaster pursuant to the authority conferred on the Administrator under Executive Order 12148, as amended.

This action ends the appointment of Robert J. Fenton as the Federal Coordinating Officer for this disaster.

The Federal Emergency Management Agency (FEMA) is pleased to announce that Kevin A. Wallace has been appointed Federal Coordinating Officer for this disaster by FEMA pursuant to authority conferred on the Administrator under Executive Order 12148, as amended.

This action ends the appointment of Jeffrey L. Coleman as Federal Director of Coordination for this disaster.

The Federal Emergency Management Agency (FEMA) is pleased to announce that FEMA has appointed Janice P. Barlow as Federal Coordinating Officer for this disaster pursuant to the authority conferred on the Administrator under Executive Order 12148, as amended.

This action ends the appointment of MaryAnn Tierney as Federal Coordinating Officer for this disaster.

The Federal Emergency Management Agency (FEMA) is hereby notified that FEMA has appointed Vincent J. Maykovich as the Federal Coordinating Officer for this disaster pursuant to the authority conferred on the Administrator under Executive Order 12148, as amended.

This action ends the appointment of Michael F. O'Hare as the Federal Coordinating Officer for this disaster.

The notice of a major disaster declaration for the state of New Jersey is amended to add the following area to the areas adversely affected by the event declared a major disaster by the President in his declaration dated December 11, 2020 were classified.

Notice is hereby given that by letter dated January 5, 2021, the President issued an emergency declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as follows:

The Federal Emergency Management Agency (FEMA) announces that Myra M. Shird has been appointed by FEMA as Official of Federal Coordination for Declared Emergency, pursuant to the authority of the Administrator of the Department of Homeland Security under Executive Order 12148, as amended.

The following areas in the state of Tennessee have been designated as adversely affected by this declared emergency:

The Federal Emergency Management Agency (FEMA) is hereby notified that FEMA has appointed Vincent J. Maykovich as the Federal Coordinating Officer for this disaster pursuant to the authority conferred on the Administrator under Executive Order 12148, as amended.

This action ends the appointment of Michael F. O'Hare as the Federal Coordinating Officer for this disaster.

The Federal Emergency Management Agency (FEMA) is pleased to announce that Tammy L. Littrell has been appointed by FEMA as Federal Coordinating Officer for this disaster pursuant to the authority conferred on the Administrator under Executive Order 12148, as amended.

This action ends the appointment of Robert J. Fenton as the Federal Coordinating Officer for this disaster.

This notice is based on the authority of the Paperwork Reduction Act 1995; 44 USC Chapter 35, as amended. An ICR is a request to OIRA seeking approval, expansion or renewal of a collection of Coast Guard information (collection). The ICR contains information describing the purpose of the collection, the anticipated burden of the collection on the affected public, an explanation of the need for the collection, and other important information describing the collection. There is an ICR for each collection.

The Coast Guard is seeking comment on whether this ICR should be granted on the basis that collection is necessary for the proper performance of the department's duties. In particular, the Coast Guard would like to receive comments on: (1) the practical usefulness of the collection; (2) the accuracy of the estimated collection fee; (3) ways to improve the quality, usefulness, and clarity of the information underlying the collection; and (4) ways to minimize the burden of collection on respondents, including the use of automated collection techniques or other forms of information technology.

In response to your comments, we may revise this ICR or decide not to seek an extension of the collection permit. We will consider all comments and materials received during the comment period.

We encourage you to respond to this request by submitting comments and related materials. Comments must include the ICR-OMB control number and the protocol number of this application [USCG-2021-0044] and be received by April 19, 2021.

We encourage you to submit comments through the Federal eRulemaking Portal athttps://www.regulations.gov.If your material cannot be submittedhttps://www.regulations.gov,contact the person belowCONTACT US FOR FURTHER INFORMATIONSection of this document for alternative instructions. Documents referenced in this release and all public comments are located in our online archive athttps://www.regulations.govand can be viewed by following the instructions on this website. Additionally, if you access the online newsletter and sign up for email alerts, you will be notified when comments are posted.

We accept anonymous comments. All comments received will be posted tohttps://www.regulations.govand includes any personal information you provide. For more information on privacy and filings in response to this document, see the DHS eRulemaking System of Records Notice (85 FR 14226, March 11, 2020).

Title:Simplified test program.

OMB Control Number:1625-0085.

Summary:The Coast Guard established an optional simplified inspection program (SIP) to provide owners and operators of US vessels with an alternative method of meeting Coast Guard inspection requirements.

To need:The SIP regulations under 46 CFR Part 8 Subpart E provide owners and operators of inspected vessels with an alternative to the traditional Coast Guard inspection procedures. Title 46 U.S.C. 3306 authorizes the Coast Guard to issue regulations necessary to conduct inspections of vessels required under 46 U.S.C. 3301 and 46 U.S.C. 3103 allows the Coast Guard to refer to reports, documents,and records of others believed to be reliable, and other methods believed to be reliable, to ensure ships' and seafarers' compliance with the requirements of 46 U.S.C. Subtitle II

To form:Not applicable.

Respondent:ship owners and operators.

Frequency:On occasion.

Estimated Credit Hours:The estimated workload increased from 8,254 hours to 13,298 hours per year due to the increase in the number of SIP subscribers (This is,companies and ships).

This notice is based on the authority of the Paperwork Reduction Act 1995; 44 USC Chapter 35, as amended. An ICR is a request to OIRA seeking approval, expansion or renewal of a collection of Coast Guard information (collection). The ICR contains information describing the purpose of the collection, the anticipated burden of the collection on the affected public, an explanation of the need for the collection, and other important information describing the collection. There is an ICR for each collection.

The Coast Guard is seeking comment on whether this ICR should be granted on the basis that collection is necessary for the proper performance of the department's duties. In particular, the Coast Guard would like to receive comments on: (1) the practical usefulness of the collection; (2) the accuracy of the estimated collection fee; (3) ways to improve the quality, usefulness, and clarity of the information underlying the collection; and (4) ways to minimize the burden of collection on respondents, including the use of automated collection techniques or other forms of information technology.

In response to your comments, we may revise this ICR or decide not to seek an extension of the collection permit. We will consider all comments and materials received during the comment period.

We encourage you to respond to this request by submitting comments and related materials. Comments must include the ICR-OMB control number and the protocol number of this application [USCG-2021-0045] and be received by April 19, 2021.

We encourage you to submit comments through the Federal eRulemaking Portal athttps://www.regulations.gov.If your material cannot be submittedhttps://www.regulations.gov,contact the person belowCONTACT US FOR FURTHER INFORMATIONSection of this document for alternative instructions. Documents referenced in this release and all public comments are located in our online archive athttps://www.regulations.govand can be viewed by following the instructions on this website. Additionally, if you access the online newsletter and sign up for email alerts, you will be notified when comments are posted.

We accept anonymous comments. All comments received will be posted tohttps://www.regulations.govand includes any personal information you provide. For more information on privacy and filings in response to this document, see the DHS eRulemaking System of Records Notice (85 FR 14226, March 11, 2020).

Title:Applications for private navigational aids and Class I private navigational aids on artificial islands and permanent structures.

OMB Control Number:1625-0011.

Summary:Pursuant to the provisions of 14 U.S.C. 81, the Coast Guard is authorized to set up navigational aids. 14 USC 83 prohibits the installation of navigational aids without Coast Guard approval. 33 CFR 66.01-5 provides individuals with the ability to establish private navigational aids. Under 43 U.S.C. 1333, the Coast Guard has authority to issue and enforce regulations relating to lights and other warning devices related to promoting the safety of life and property on man-made islands, facilities and other devices on the outer continental shelf engaged in exploration, Development, removal or transporting resources from there. 33 CFR 67.35-1 dictates the type of navigational aids that must be installed on man-made islands and fixed structures. Pursuant to the provisions of 33 U.S.C. 409, the Minister of Homeland Security is charged with prescribing rules and regulations for marking sunken ships. This authorization has been delegated to the Commander of the Coast Guard under Department of Homeland Security delegation number 0170, and the marking of sunken ships is specified in 33 CFR Part 64.11. To change regulations, 5 U.S.C. 553 requires that the regulation be published in theFederal registrationand that the notice must include an indication of the time, place and nature of the public regulationProcess. Information collected for the rule can only be obtained from owners of sunken ships. Information collection requirements are contained in 33 CFR 66.01-5 and 67.35-5.

To need:Information on these private auxiliary missions (CG-2554 and CG-4143) provide the Coast Guard with vital information on private navigational aids and are essential to safe maritime navigation. These forms are required by 33 CFR 66 and 67. The information is processed to ensure that the private grant is compliant with applicable regulations. In addition, these Coast Guard forms provide information that can be distributed to the public to notify of new aids or changes to private navigational aids. Additionally, collecting the applicant's contact information is important as it allows the Coast Guard to contact the applicant in the event of a discrepancy or mishap regarding permitted private navigational aid. Certain discrepancies present hazards to navigation and must be corrected or repaired immediately.

To form:

• CG-2554, Private Navigation Aid Application.

• CG-4143, Application for Class I Private Assistance for Navigation on Artificial Islands and Fixed Structures.

Respondent:Owners of private navigation aids.

Frequency:On occasion.

Estimated Credit Hours:The estimated annual exposure decreased from 1,709 hours in 2017 to 712 hours in 2020 due to the decrease in the number of respondents per year.

Authority:The 1995 Bureaucracy Reduction Act; 44 USC Chapter 35, as amended.

The Federal Emergency Management Agency (FEMA) is pleased to announce that Nancy J. Dragani has been appointed by FEMA as the Federal Coordinating Officer for this disaster pursuant to the authority of Administrator under Executive Order 12148, as amended.

This action ends the appointment of Lee K. dePalo as the Federal Coordinating Officer for this disaster.

The Federal Emergency Management Agency (FEMA) is pleased to announce that Paul F. Ford has been appointed Federal Coordinating Officer for this disaster by FEMA pursuant to the authority of Administrator under Executive Order 12148, as amended.

This action ends the appointment of W. Russell Webster as Federal Director of Coordination for this disaster.

The Notice of a Major Disaster Declaration for the State of Alabama is amended to add the following area to the areas designated as Adversely Affected by the event declared a Major Disaster by the President in his December 10, 2020 declaration .