Section 312 of the Coastal Zone Management Act requires NOAA to conduct periodic evaluations of federally approved state coastal programs and national estuarine research reserves. The process includes one or more public meetings, consideration of written public comments, and consultations with interested Federal, state, and local agencies and members of the public. For the evaluation of Indiana's Lake Michigan Coastal Management Program NOAA will consider the extent to which the state has met the national objectives, adhered to the management program approved by the Secretary of Commerce, and adhered to the terms of financial assistance under the Coastal Zone Management Act. When the evaluation is completed, NOAA's Office for Coastal Management will place a notice in the Federal Register announcing the availability of the Final Evaluation Findings.

Background

The petitioners in this investigation are Insteel Industries Inc., Mid-South Wire Company, National Wire LLC, Oklahoma Steel & Wire Co., and Wire Mesh Corp. (collectively, the petitioners). In addition to the Government of Mexico, the mandatory respondents in this investigation are Aceromex S.A. De C.V. (Aceromex) and Deacero S.A.P.I. de C.V. (Deacero).

A summary of the events that occurred since Commerce published the Preliminary Determination, 1 as well as a full discussion of the issues raised by parties for this final determination, are discussed in the Issues and Decision Memorandum, which is hereby adopted by this notice. 2 The Issues and Decision Memorandum is a public document and on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/. The signed and electronic versions of the Issues and Decision Memorandum are identical in content.

The period of investigation is January 1, 2019 through December 31, 2019.

The scope of the investigation is wire mesh from Mexico. For a complete description of the scope of this investigation, see Appendix I.

The subsidy programs under investigation and the issues raised in the case and rebuttal briefs by parties in this investigation are discussed in the Issues and Decision Memorandum. A list of the issues that parties raised, and to which we responded in the Issues and Decision Memorandum, is included as Appendix II.

Commerce conducted this investigation in accordance with section 701 of the Tariff Act of 1930, as amended (the Act). For each of the subsidy programs found countervailable, Commerce determines that there is a subsidy, i.e., a financial contribution by an “authority” that confers a benefit on the recipient and that the subsidy is specific. 3 For a full description of the methodology underlying our final determination, see the Issues and Decision Memorandum.

In making this final determination, Commerce relied, in part, on facts available pursuant to section 776(a) of the Act. Additionally, as discussed in the Issues and Decision Memorandum, because one respondent did not act to the best of their ability in responding to our requests for information, we drew adverse inferences, where appropriate, in selecting from among the facts otherwise available, pursuant to section 776(b) of the Act. The respondent, Deacero, did not respond to Commerce's initial countervailing duty (CVD) questionnaire, and we have continued to use an adverse inference in selection of facts available for determining the subsidy rates for these companies, pursuant to section 776(d) of the Act. For further information, see the section “Use of Facts Otherwise Available and Adverse Inferences” in the accompanying Issues and Decision Memorandum.

Commerce was unable to conduct on-site verification of the information relied upon in making its final determination in this investigation. However, we took additional steps in lieu of an on-site verification to verify the information relied upon in making this final determination, in accordance with section 782(i) of the Act. 4

Based on our review and analysis of the information received in lieu of on-site verification, we made certain changes to the subsidy rate calculations for Aceromex. As a result of these changes, Commerce also revised the all-others rate. For a discussion of these changes, see the Issues and Decision Memorandum. 5

In accordance with section 705(c)(1)(B)(i)(I) of the Act, we calculated a countervailable subsidy rate for Aceromex. Section 705(c)(5)(A)(i) of the Act states that, for all exporters and producers not individually investigated, we will determine an all-others rate equal to the weighted-average countervailable subsidy rates established for exporters and producers individually investigated, excluding any zero and de minimis countervailable subsidy rates, and any rates determined entirely under section 776 of the Act.

In this investigation, Commerce assigned a rate based entirely on facts available, i.e., under section 776 of the Act, to Deacero. Therefore, the only rate that is not zero, de minimis, or based entirely on facts otherwise available is the rate calculated for Aceromex. Consequently, the rate calculated for Aceromex is also assigned as the rate for all other producers and exporters.

Commerce determines that the following estimated countervailable subsidy rates exist:

Commerce intends to disclose the calculations performed in connection with this final determination within five days of the date of publication of this notice to parties in this proceeding in accordance with 19 CFR 351.224(b).

As a result of our Preliminary Determination and pursuant to sections 703(d)(1)(B) and (d)(2) of the Act, Commerce instructed U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise as described in the scope of the investigation section, that was entered or withdrawn from warehouse for consumption on or after the date of publication of the Preliminary Determination in the Federal Register .

If the U.S. International Trade Commission (ITC) issues a final affirmative injury determination, we will issue a CVD order and require a cash deposit of estimated countervailing duties for such entries of subject merchandise in the amounts indicated above. If the ITC determines that material injury, or threat of material injury, does not exist, this proceeding will be terminated and all estimated duties deposited or securities posted as a result of the suspension of liquidation will be refunded or canceled.

In accordance with section 705(d) of the Act, we will notify the ITC of our determination. In addition, we are making available to the ITC all non-privileged and non-proprietary information related to this investigation. We will allow the ITC access to all privileged and business proprietary information in our files, provided the ITC confirms that it will not disclose such information, either publicly or under an administrative protective order (APO), without the written consent of the Assistant Secretary for Enforcement and Compliance.

Because the final determination in this proceeding is affirmative, in accordance with section 705(b) of the Act, the ITC will make its final determination as to whether the domestic industry in the United States is materially injured, or threatened with material injury, by reason of imports of wire mesh from Mexico no later than 45 days after our final determination. If the ITC determines that material injury or threat of material injury does not exist, this proceeding will be terminated and all cash deposits will be refunded. If the ITC determines that such injury does exist, Commerce will issue a CVD order directing CBP to assess, upon further instruction by Commerce, countervailing duties on all imports of the subject merchandise that are entered, or withdrawn from warehouse, for consumption on or after the effective date of the suspension of liquidation, as discussed above in the “Continuation of Suspension of Liquidation” section.

In the event that the ITC issues a final negative injury determination, this notice will serve as the only reminder to parties subject to the APO of their responsibility concerning the destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.

This determination is issued and published pursuant to sections 705(d) and 777(i) of the Act.

Species Covered in This Notice

The following listed species are covered in this notice:

Puget Sound Chinook salmon ( Oncorhynchus tshawytscha ): Threatened, naturally produced, and artificially propagated;

Puget Sound steelhead ( O. mykiss ): Threatened, naturally produced, and artificially propagated Puget Sound;

Puget Sound chum salmon ( O. keta ): Threatened, naturally produced, and artificially propagated;

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

Snake River steelhead ( O. mykiss ): Threatened, naturally produced, and artificially propagated;

Snake River sockeye salmon ( O. nerka ): Threatened, naturally produced, and artificially propagated;

Lower Columbia River Chinook salmon ( O. tshawytscha ): Threatened, naturally, and artificially propagated;

Lower Columbia River coho salmon ( O. kisutch ): Threatened, naturally produced, and artificially propagated;

Lower Columbia River steelhead ( O. mykiss ): Threatened, naturally, and artificially propagated; and

Lower Columbia River chum salmon ( O. keta ): Endangered, naturally, and artificially propagated.

Duwamish-Green: The 10 joint plans for programs located in this basin intend to conserve ESA-listed fall Chinook salmon and winter steelhead while also providing harvest opportunities for these species when adult return abundances allow. Additionally, 2 of the 10 hatchery programs will provide a prey base for the endangered Southern Resident Killer Whales (SRKW). The joint plans also provide fall chum salmon for harvest.

Stillaguamish: The four joint plans for programs located in this basin intend for conservation, mitigation, and to provide for tribal and non-tribal harvest pursuant to the Puget Sound Salmon Management Plan implemented under United States v. Washington and treaty rights. The Chinook salmon joint plans are consistent with the Stillaguamish Watershed Chinook Salmon Recovery Plan (Stillaguamish Implementation Review Committee [SIRC] 2005) along with the Puget Sound Salmon Conservation Plan (Shared Strategy for Puget Sound 2007).

Yankee-Panther: The two joint plans submitted by the Shoshone/Bannock Tribes seek to restore fishing opportunities for tribal members through Chinook salmon hatchery programs in the Yankee Fork and Panther Creek watersheds. Restoration of these ceremonial and subsistence fisheries would be accomplished consistently with the recovery and long-term sustainability of Chinook salmon in the upper Salmon River basin.

Elochoman: The Washington Department of Fish and Wildlife proposes to restore a late-returning coho program in the Elochoman watershed. The program intends to reduce hatchery production impacts to ESA-listed Lower Columbia River coho by integrating natural-origin coho into the conservation program while providing tribal, sport, and commercial harvest opportunities through the segregated portion of the program. Due to facility issues, the Grays River Hatchery late coho program has ended, and that program's production has shifted to the Beaver Creek Hatchery.

All of the submitted HGMPs are consistent with each of the ESA-listed species' recovery plans and designed to help conserve their populations across the Evolutionary Significant Units (ESU) and or Distinct Population Segment (DPS) range. NMFS, through its evaluation, has determined each of the programs are designed and operated to ensure that the impacts to ESA-listed natural-origin Chinook salmon, coho salmon, chum salmon, and steelhead populations will not appreciably reduce the survival and recovery of listed species. The programs use adaptive management procedures and the best available science to reduce adverse genetic effects and lessen competition and predation impacts typically associated with salmon and steelhead hatchery programs. Monitoring and evaluation will be implemented to assess each program's performance in meeting population conservation or harvest augmentation objectives and their effects on ESA-listed natural-origin Chinook salmon, coho salmon, chum salmon, and steelhead. The information gained through monitoring and evaluation will be used to assess whether the programs' impacts on listed fish are consistent with NMFS' determinations.

A review of monitoring and evaluation results by NMFS and the co-managers will occur annually to evaluate whether assumptions regarding the HGMP and joint plans' effects and analysis remain valid and whether the objectives are being accomplished. The HGMPs include provisions for annual reports that will assess compliance with performance standards established through the HGMPs. Reporting and inclusion of new information derived from HGMPs' research, monitoring, and evaluation activities provides NMFS with the information required to determine what performance standards have been met.

Duwamish-Green: NMFS published a notice of its Proposed Evaluation and Pending Determination (PEPD) on the joint plans for public review and comment on April 2, 2019 (84 FR 12593), as required by the ESA Section 4(d) Rule. The PEPD was available for public review and comment for 30 days. NMFS received four comments relevant to the PEPD. Our responses to those comments are addressed in our Evaluation and Recommended Determination (ERD). Based on our ERD and considering the public comments, NMFS issued its final determination for the Duwamish-Green River HGMP.

Stillaguamish: NMFS published a notice of its draft Environmental Assessment (EA) and PEPD on the proposed joint plans for public review and comment on June 28, 2019 (84 FR 31031), as required by the ESA 4(d) Rule. The EA and PEPD were available for public review and comment for 30 days, NMFS received two comments. Based on our ERD and considering the public comments, NMFS issued its final determination on the Stillaguamish River HGMPs.

Yankee-Panther: NMFS published a notice of its EA and PEPD on the joint plans for public review and comment on March 10, 2020 (85 FR 13876), as required by the ESA 4(d) Rule. The EA and PEPD were available for public review and comment for 30 days. NMFS received no comments. Based on our ERD, NMFS issued its final determination on the Yankee Fork and Panther Creek HGMPs.

Elochoman/Beaver Creek: NMFS published a notice of availability of the HGMP for public review and comment on October 4, 2019 (84 FR 53104), as required by the ESA Section 4(d) Rule. The HGMP was available for public review and comment for 30 days. NMFS received no comments. Based on our ERD, NMFS approved the Elochoman River HGMP.

Duwamish: The notice of the FEIS availability was published in the Federal Register on July 12, 2019 (84 FR 33256). NMFS has decided to select the agency's preferred alternative, Alternative 5, from the FEIS. Under the selected alternative, NMFS determined that the co-managers' joint plans met the requirements of limit 6 of the ESA 4(d) Rule. The 10 salmon and steelhead hatchery programs in the Duwamish-Green River Basin would be implemented as described in the submitted joint plans. The ROD documents NMFS's decision, identifies all alternatives considered in reaching the decision, specifies the alternative considered to be environmentally preferable, and identifies and discusses relevant factors balanced by NMFS in making its decision.

Stillaguamish: NMFS has decided to select the agency's preferred alternative, Alternative 2, from the final EA. Under the selected alternative, NMFS determined that the co-managers' joint plans met the requirements of limits 6 of the ESA 4(d) Rule. The four hatchery programs in the Stillaguamish River Basin would be implemented as described in the submitted joint plans. The FONSI documents NMFS's decision that the proposed joint plans are not likely to significantly affect the human environment.

Yankee-Panther Creek: NMFS has decided to select the agency's preferred alternative in the EA, Alternative 2. Under the selected alternative, NMFS would determine that the co-managers' joint plans met the requirements of limit 6 of the ESA 4(d) Rule. The two hatchery programs in the Upper Salmon River Basin would be implemented as described in the submitted joint plans. The FONSI documents NMFS's decision that the proposed joint plans are not likely to significantly affect the human environment.

Elochoman/Beaver Creek: NMFS determined that the HGMP submitted by The Washington Dept. of Fish and Wildlife (WDFW) met the requirements of limit 5 of the ESA 4(d) Rule. The proposed action does not differ from that analyzed in the existing NEPA analysis (2014 Mitchell Act FEIS). The Supplemental Information Report (SIR) adequately addresses the impacts of the proposed action on the human environment and evaluates new information available since the existing NEPA analysis. The hatchery program in the Elochoman River Basin would be implemented as described in the submitted HGMP.

16 U.S.C. 1531-1543; subpart B, § 223.201-202 also issued under 16 U.S.C. 1361 et seq.; 16 U.S.C. 5503(d) for § 223.206(d)(9).

The Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils, in conjunction with NOAA Fisheries and the Atlantic and Gulf States Marine Fisheries Commissions have implemented the Southeast Data, Assessment and Review (SEDAR) process, a multi-step method for determining the status of fish stocks in the Southeast Region. SEDAR is a multi-step process including: (1) Data Workshop, (2) A series of assessment webinars, and (3) A Review Workshop. The product of the Data Workshop is a report that compiles and evaluates potential datasets and recommends which datasets are appropriate for assessment analyses. The assessment webinars produce a report that describes the fisheries, evaluates the status of the stock, estimates biological benchmarks, projects future population conditions, and recommends research and monitoring needs. The product of the Review Workshop is an Assessment Summary documenting panel opinions regarding the strengths and weaknesses of the stock assessment and input data. Participants for SEDAR Workshops are appointed by the Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils and NOAA Fisheries Southeast Regional Office, HMS Management Division, and Southeast Fisheries Science Center. Participants include data collectors and database managers; stock assessment scientists, biologists, and researchers; constituency representatives including fishermen, environmentalists, and NGO's; International experts; and staff of Councils, Commissions, and state and federal agencies.

The items of discussion during the Assessment Webinar are as follows:

• Using datasets and initial assessment analysis recommended from the data webinars, panelists will employ assessment models to evaluate stock status, estimate population benchmarks and management criteria, and project future conditions.

• Participants will recommend the most appropriate methods and configurations for determining stock status and estimating population parameters.

Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.

The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to the Council office (see ADDRESSES ) at least 5 business days prior to each webinar.

On December 11, 2019, Commerce initiated the administrative review of the antidumping duty order on certain hot-rolled steel flat products (hot-rolled steel) from the Republic of Korea (Korea) in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act). 1 This review covers one producer/exporter of subject merchandise, Hyundai Steel Company (Hyundai). On April 24, 2020, Commerce exercised its discretion to toll all deadlines for administrative reviews by 50 days, resulting in a revised deadline for these preliminary results. 2 On July 21, 2020, Commerce tolled all deadlines again in administrative reviews by an additional 60 days. 3 Additionally, Commerce exercised its discretion to extend the deadline for the preliminary results until February 17, 2021. 4

The products covered by this Order   5 are certain hot-rolled, flat-rolled steel products. For a full description of the scope, see the Preliminary Decision Memorandum. 6

Commerce is conducting this review in accordance with section 751(a) of the Act. Export price and constructed export price are calculated in accordance with section 772 of the Act. Normal value is calculated in accordance with section 773 of the Act.

For a full description of the methodology underlying these preliminary results, see the Preliminary Decision Memorandum. The Preliminary Decision Memorandum is a public document and is made available to the public via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov. In addition, a complete version of the Preliminary Decision Memorandum is available at http://enforcement.trade.gov/frn/. A list of the topics included in the Preliminary Decision Memorandum is included as an appendix to this notice.

We preliminarily determine that the following weighted-average dumping margin exists for the period October 1, 2018, through September 30, 2019:

We intend to disclose the calculations performed to parties within five days after public announcement of the preliminary results. 7 Pursuant to 19 CFR 351.309(c), interested parties may submit case briefs no later than 30 days after the date of publication of this notice. Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than seven days after the date for filing case briefs. 8 Commerce modified certain of its requirements for serving documents containing business proprietary information until further notice. 9 Parties who submit case briefs or rebuttal briefs in this proceeding are encouraged to submit with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities. 10 Case and rebuttal briefs should be filed using ACCESS11 and must be served on interested parties.12 Executive summaries should be limited to five pages total, including footnotes.

Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS. Requests should contain: (1) The party's name, address, and telephone number; (2) the number of participants; and (3) a list of issues to be discussed. Issues raised in the hearing will be limited to those raised in the respective case briefs. An electronically filed hearing request must be received successfully in its entirety by Commerce's electronic records system, ACCESS, by 5:00 p.m. Eastern Time within 30 days after the date of publication of this notice.

Commerce intends to issue the final results of this administrative review, including the results of its analysis of the issues raised in any written briefs, not later than 120 days after the date of publication of this notice, pursuant to section 751(a)(3)(A) of the Act and 19 CFR 351.213(h)(1).

Upon completion of the final results, Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries. If Hyundai's weighted-average dumping margin is above de minimis in the final results of this review, we will calculate an importer-specific assessment rate on the basis of the ratio of the total amount of dumping calculated for each importer's examined sales and the total entered value of those same sales in accordance with 19 CFR 351.212(b)(1). 13 If Hyundai's weighted-average dumping margin or an importer-specific assessment rate is zero or de minimis in the final results of review, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties. 14 The final results of this administrative review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by the final results of this review and for future deposits of estimated duties, where applicable. 15

For entries of subject merchandise during the POR produced by Hyundai for which it did not know that the merchandise was destined to the United States, we will instruct CBP to liquidate unreviewed entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction. 16

Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the Federal Register . If a timely summons is filed at the U.S. Court of International Trade, the assessment instructions will direct CBP not to liquidate relevant entries until the time for parties to file a request for a statutory injunction has expired ( i.e., within 90 days of publication).

The following cash deposit requirements will be effective upon publication in the Federal Register of the notice of final results of administrative review for all shipments of hot-rolled steel from Korea entered, or withdrawn from warehouse, for consumption on or after the date of publication as provided by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for Hyundai will be equal to the weighted-average dumping margin established in the final results of this administrative review; (2) for merchandise exported by a company not covered in this review but covered in a prior segment of the proceeding, the cash deposit rate will continue to be the company-specific rate published in the completed segment for the most recent period; (3) if the exporter is not a firm covered in this review or the original investigation but the producer is, then the cash deposit rate will be the rate established in the completed segment for the most recent period for the producer of the merchandise; (4) the cash deposit rate for all other producers or exporters will continue to be 6.05 percent, the all-others rate established in the less-than-fair-value investigation. 17 These cash deposit requirements, when imposed, shall remain in effect until further notice.

This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of doubled antidumping duties.

We are issuing and publishing these results in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.221.

These meetings are available to the public through the web link above. If joining only via phone, callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Individuals who are deaf, deafblind and hard of hearing. may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with conference details found through registering at the web link above. To request additional accommodations, please email mtrachtenberg@usccr.gov at least 7 days prior to the meeting for which accommodations are requested.

Members of the public are entitled to make comments during the open period of the meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be emailed to Mallory Trachtenberg at mtrachtenberg@usccr.gov. Persons who desire additional information may contact the Regional Programs Unit at (202) 809-9618. Records and documents discussed during the meeting will be available for public viewing as they become available at www.facadatabase.gov. Persons interested in the work of this advisory committee are advised to go to the Commission's website, www.usccr.gov, or to contact the Regional Programs Unit at the above phone number or email address.

This meeting is available to the public through the following toll-free call-in number: 800-367-2403, conference ID number: 6603878. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the conference call number and conference ID number.

Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be mailed to the Western Regional Office, U.S. Commission on Civil Rights, 300 North Los Angeles Street, Suite 2010, Los Angeles, CA 90012 or email Ana Victoria Fortes at afortes@usccr.gov.

Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at https://www.facadatabase.gov/FACA/FACAPublicViewCommitteeDetails?id=a10t0000001gzlyAAA.

Records generated from this meeting may also be inspected and reproduced at the Regional Programs Unit, as they become available, both before and after the meeting. Persons interested in the work of this Committee are directed to the Commission's website, http://www.usccr.gov, or may contact the Regional Programs Unit at the above email or street address.

Fort Benning plays a critical role in supporting the Army's overarching mission. As the Army's MCoE, the home of the Army's Armor and Infantry Schools, Fort Benning must support the institutional training of Infantry and Armor soldiers and leaders. The institutional training conducted at Fort Benning provides Army leaders with the opportunity to respond to a wide variety of situations that they can expect to encounter on the modern battlefield. Fort Benning is also home to several deployable units that conduct off-road mounted maneuver training, including the 1st Security Force Assistance Brigade, Task Force 1-28 Infantry, and elements of the 75th Ranger Regiment.

Fort Benning must be able to train and develop highly skilled and cohesive units capable of conducting operations across the full spectrum of potential conflicts. Inherent in and vital to training Infantry and Armor soldiers and leaders properly is the requirement to provide sufficient heavy off-road mounted maneuver training area. Currently, the only training area at Fort Benning suitable for heavy off-road mounted maneuver training is the Good Hope Maneuver Training Area (GHMTA). Since the initial development of the GHMTA, the Army's training strategy has changed to “cross-domain movement and maneuver” that requires additional contiguous area for heavy off-road maneuver.

The Final EIS analyzes the potential environmental and socioeconomic impacts associated with the Proposed Action, including direct, indirect, and cumulative effects. Mitigation of adverse effects through avoidance and environmentally sensitive design, such as establishment of buffers, would be used to avoid impacts to sensitive resources to the maximum extent practicable. The Final EIS identifies additional mitigation measures that the Army may implement to further reduce identified adverse impacts.

The Army has completed consultation for this action under Section 7 of the Endangered Species Act, and this is incorporated in the EIS.

The Army identified three reasonable Action Alternatives that would meet the purpose of and need for the Proposed Action; these three Action Alternatives ( i.e., three distinct locations on Fort Benning where a HOMMTA could be constructed) are analyzed in detail in the Final EIS.

1. Alternative 1 (Preferred Alternative): Northern Mounted Maneuver Training Area Alternative: This alternative includes approximately 4,724 acres and is located adjacent to and east of the current Northern Maneuver Training Area and west of and near Fort Benning's Digital Multi-Purpose Range Complex (DMPRC).

Of the Action Alternatives, Alternative 1 would provide the most preferable size and configuration to enable high-quality heavy off-road mounted maneuver training. Accordingly, the Army has identified Alternative 1 as the Preferred Alternative to implement the Proposed Action.

2. Alternative 2: Red Diamond Alternative: This alternative includes approximately 3,744 acres and is located south of the Southern Maneuver Training Area (SMTA) near the Installation's southern boundary.

3. Alternative 3: Eastern Boundary Alternative: This alternative includes approximately 2,405 acres and is located between the northern dudded impact area and the Installation's eastern boundary.

The Army also carried forward the No Action Alternative for detailed analysis in the Final EIS. While the No Action Alternative would not satisfy the purpose and need for the Proposed Action, this Alternative was retained to provide a comparative baseline against which to analyze the effects of the Action Alternatives as required under the Council on Environmental Quality's NEPA Regulation.

Resource areas analyzed in the Final EIS include: Land use (recreation), air quality, noise, soils and topography, water resources (including wetlands and floodplains), biological resources, cultural resources, socioeconomics, infrastructure, and hazardous and toxic materials and waste.

Based on the analysis presented in the Final EIS, potentially significant adverse impacts could occur to biological resources ( i.e., from disturbance of unique ecological areas). Impacts to all other resource areas would be less-than-significant ( i.e., negligible, minor, or moderate) adverse or beneficial. Practical mitigation measures are presented in the Final EIS to reduce potential adverse effects.

All Action Alternatives for the Proposed Action may adversely impact wetlands and/or 100-year floodplains. Accordingly, the Army has also prepared a FONPA to comply with Executive Order (E.O.) 11988, Floodplain Management, and E.O. 11990, Protection of Wetlands. As described in the Final EIS, environmental protection measures ( e.g., buffers from heavy maneuver training) and regulatory compliance measures ( e.g., permitting under Sections 401 and 404 of the CWA) would be implemented to minimize adverse impacts on these resources.

The Army conducted a public review and comment period for the Draft EIS between May 29 and July 13, 2020, including a public teleconference on June 30, 2020. The Army considered and addressed in the Final EIS comments received on the Draft EIS during this comment period.

Printed copies of the Final EIS and FONPA will be made available to the public for 30 days at the Columbus Public Library, Cusseta-Chattahoochee County Public Library, Milton E. Long Library, and the Phenix City-Russell County Library, if the libraries are open for public visitation when this NOA is published. An electronic copy of the Final EIS and FONPA is posted on the HOMMTA EIS web page at https://www.benning.army.mil.

After publication of this NOA of the Final EIS, the Army will prepare and publish its ROD announcing which Alternative is environmentally preferred, which Alternative it selects for implementation (be it an Action Alternative or the No Action Alternative), and which mitigation measures it will implement to reduce potential adverse impacts. Publication of the ROD will occur no sooner than 30 days after publication of this NOA of the Final EIS.

DOE is publishing Hussmann's petition for waiver in its entirety in appendix A to this document, pursuant to 10 CFR 431.401(b)(1)(iv).  1 DOE invites all interested parties to submit in writing by March 22, 2021, comments and information on all aspects of the petition, including the alternate test procedure. Pursuant to 10 CFR 431.401(d), any person submitting written comments to DOE must also send a copy of such comments to the petitioner. The contact information for the petitioner is Ronald Shebik, ron.shebik@hussmann.com, 12999 St. Charles Rock Road, Bridgeton, MO 63044.

Submitting comments via http://www.regulations.gov. The http://www.regulations.gov web page will require you to provide your name and contact information. Your contact information will be viewable to DOE Building Technologies staff only. Your contact information will not be publicly viewable except for your first and last names, organization name (if any), and submitter representative name (if any). If your comment is not processed properly because of technical difficulties, DOE will use this information to contact you. If DOE cannot read your comment due to technical difficulties and cannot contact you for clarification, DOE may not be able to consider your comment.

However, your contact information will be publicly viewable if you include it in the comment or in any documents attached to your comment. Any information that you do not want to be publicly viewable should not be included in your comment, nor in any document attached to your comment. If this instruction is followed, persons viewing comments will see only first and last names, organization names, correspondence containing comments, and any documents submitted with the comments.

Do not submit to http://www.regulations.gov information for which disclosure is restricted by statute, such as trade secrets and commercial or financial information (hereinafter referred to as Confidential Business Information (“CBI”)). Comments submitted through http://www.regulations.gov cannot be claimed as CBI. Comments received through the website will waive any CBI claims for the information submitted. For information on submitting CBI, see the Confidential Business Information section.

DOE processes submissions made through http://www.regulations.gov before posting. Normally, comments will be posted within a few days of being submitted. However, if large volumes of comments are being processed simultaneously, your comment may not be viewable for up to several weeks. Please keep the comment tracking number that http://www.regulations.gov provides after you have successfully uploaded your comment.

Submitting comments via email, hand delivery/courier, or postal mail. Comments and documents submitted via email, hand delivery/courier, or postal mail also will be posted to http://www.regulations.gov. If you do not want your personal contact information to be publicly viewable, do not include it in your comment or any accompanying documents. Instead, provide your contact information on a cover letter. Include your first and last names, email address, telephone number, and optional mailing address. The cover letter will not be publicly viewable as long as it does not include any comments.

Include contact information each time you submit comments, data, documents, and other information to DOE. If you submit via postal mail or hand delivery/courier, please provide all items on a CD, if feasible, in which case it is not necessary to submit printed copies. Faxes will not be accepted.

Comments, data, and other information submitted to DOE electronically should be provided in PDF (preferred), Microsoft Word or Excel, WordPerfect, or text (ASCII) file format. Provide documents that are not secured, written in English and free of any defects or viruses. Documents should not contain special characters or any form of encryption and, if possible, they should carry the electronic signature of the author.

Campaign form letters. Please submit campaign form letters by the originating organization in batches of between 50 to 500 form letters per PDF or as one form letter with a list of supporters' names compiled into one or more PDFs. This reduces comment processing and posting time.

Confidential Business Information. According to 10 CFR 1004.11, any person submitting information that he or she believes to be confidential and exempt by law from public disclosure should submit via email, postal mail, or hand delivery/courier two well-marked copies: One copy of the document marked confidential including all the information believed to be confidential, and one copy of the document marked “non-confidential” with the information believed to be confidential deleted. Submit these documents via email or on a CD, if feasible. DOE will make its own determination about the confidential status of the information and treat it according to its determination.

It is DOE's policy that all comments may be included in the public docket, without change and as received, including any personal information provided in the comments (except information deemed to be exempt from public disclosure).

The Energy Policy and Conservation Act, as amended (“EPCA”), 2 authorizes the U.S. Department of Energy (“DOE”) to regulate the energy efficiency of a number of consumer products and certain industrial equipment (42 U.S.C. 6291-6317). Title III, Part C  3 of EPCA (42 U.S.C. 6311-6316, as codified), added by the National Energy Conservation Policy Act, Public Law 95-619, sec. 441 (Nov. 9, 1978), established the Energy Conservation Program for Certain Industrial Equipment, which sets forth a variety of provisions designed to improve the energy efficiency for certain types of industrial equipment. Through amendments brought about by the Energy Independence and Security Act of 2007, Public Law 110-140, sec. 312 (Dec. 19, 2007), this equipment includes walk-in cooler and walk-in freezer (collectively, “walk-in”) refrigeration systems, the focus of this document (42 U.S.C. 6311(1)(G)).

The energy conservation program under EPCA consists essentially of four parts: (1) Testing, (2) labeling, (3) Federal energy conservation standards, and (4) certification and enforcement procedures. Relevant provisions of EPCA include definitions (42 U.S.C. 6311), energy conservation standards (42 U.S.C. 6313), test procedures (42 U.S.C. 6314), labeling provisions (42 U.S.C. 6315), and the authority to require information and reports from manufacturers (42 U.S.C. 6316).

The Federal testing requirements consist of test procedures that manufacturers of covered equipment must use as the basis for: (1) Certifying to DOE that their equipment complies with the applicable energy conservation standards adopted pursuant to EPCA (42 U.S.C. 6316(a); 42 U.S.C. 6295(s)), and (2) making representations about the efficiency of that equipment (42 U.S.C. 6314(d)). Similarly, DOE must use these test procedures to determine whether the covered equipment complies with relevant standards promulgated under EPCA. (42 U.S.C. 6316(a); 42 U.S.C. 6295(s))

Under 42 U.S.C. 6314, EPCA sets forth the criteria and procedures DOE is required to follow when prescribing or amending test procedures for covered equipment. EPCA requires that any test procedures prescribed or amended under this section must be reasonably designed to produce test results which reflect the energy efficiency, energy use or estimated annual operating cost of covered equipment during a representative average use cycle and requires that test procedures not be unduly burdensome to conduct (42 U.S.C. 6314(a)(2)). The test procedure for walk-in refrigeration systems is contained in the Code of Federal Regulations (“CFR”) at 10 CFR part 431, subpart R, appendix C, Uniform Test Method for the Measurement of Net Capacity and AWEF of Walk-In Cooler and Walk-In Freezer Refrigeration Systems (“Appendix C”).

Under 10 CFR 431.401, any interested person may submit a petition for waiver from DOE's test procedure requirements. DOE will grant a waiver from the test procedure requirements if DOE determines either that the basic model for which the waiver was requested contains a design characteristic that prevents testing of the basic model according to the prescribed test procedures, or that the prescribed test procedures evaluate the basic model in a manner so unrepresentative of its true energy consumption characteristics as to provide materially inaccurate comparative data. 10 CFR 431.401(f)(2). A petitioner must include in its petition any alternate test procedures known to the petitioner to evaluate the performance of the equipment type in a manner representative of the energy consumption characteristics of the basic model. 10 CFR 431.401(b)(1)(iii). DOE may grant the waiver subject to conditions, including adherence to alternate test procedures specified by DOE. 10 CFR 431.401(f)(2).

As soon as practicable after the granting of any waiver, DOE will publish in the Federal Register a notice of proposed rulemaking to amend its regulations so as to eliminate any need for the continuation of such waiver. 10 CFR 431.401(l). As soon thereafter as practicable, DOE will publish in the Federal Register a final rule to that effect. Id.

The waiver process also provides that DOE may grant an interim waiver if it appears likely that the underlying petition for waiver will be granted and/or if DOE determines that it would be desirable for public policy reasons to grant immediate relief pending a determination on the underlying petition for waiver. 10 CFR 431.401(e)(2). Within one year of issuance of an interim waiver, DOE will either: (i) Publish in the Federal Register a determination on the petition for waiver; or (ii) publish in the Federal Register a new or amended test procedure that addresses the issues presented in the waiver. 10 CFR 431.401(h)(1).

When DOE amends the test procedure to address the issues presented in a waiver, the waiver will automatically terminate on the date on which use of that test procedure is required to demonstrate compliance. 10 CFR 431.401(h)(2).

On July 16, 2020, Hussmann filed a petition for waiver and interim waiver from the test procedure for walk-in refrigeration systems set forth at 10 CFR part 431, subpart R, appendix C (Hussmann, No. 1 at p. 1  4 ). Hussmann also included Appendix I to their petition with clarifications and responses to two questions posed to Hussmann by DOE regarding their CO 2 direct expansion unit cooler subject basic models (Hussmann, No. 1 at p. 7-8). Hussmann claims that the test conditions described in Table 15 and Table 16 of the Air-Conditioning, Heating, and Refrigeration Institute (“AHRI”) Standard 1250-2009, Standard for Performance Rating of Walk-In Coolers and Freezers (“AHRI 1250-2009”) (for walk-in refrigerator unit coolers and freezer unit coolers tested alone, respectively), as incorporated by Appendix C with modification, cannot be achieved by the specified basic models and are not consistent with operation of Hussmann's CO 2 direct expansion unit coolers. Hussmann stated that CO 2 has a critical temperature of 87.8 °F  5 , and thus the required liquid inlet saturation temperature of 105 °F and the required liquid inlet subcooling temperature of 9 °F required in DOE's test procedure are not achievable, and that the test conditions should be more consistent with typical operating conditions for a transcritical CO 2 booster system (Hussmann, No. 1 at p.3).

The statements made by Hussmann reference the difference in thermodynamic properties between CO 2 and other refrigerants. At modest pressures ( i.e. below the critical point), many substances transition from a solid to a liquid to a gas as temperature increases. For example, a pure substance like water transitions from liquid to steam at a specific temperature, e.g. 212 °F, at atmospheric pressure. As heat is added during a liquid to gas transition, the temperature remains constant and the substance coexists as both liquid and vapor. Continuing to add heat converts more of the liquid to vapor at a constant temperature. The reverse occurs when heat is removed. However, the transition temperature depends on the pressure—the higher the pressure, the higher the transition temperature. This is a key principle in refrigeration systems, which operate at two pressure levels associated with two temperatures. A refrigerant absorbs heat when it is at a low temperature and pressure, converting to gas and cooling the surrounding space. At high temperature and pressure, the refrigerant transitions to a liquid while releasing heat to the environment. A compressor is used to raise the low-pressure gas to a high pressure, and a throttle (pressure reduction device) is used to reduce the pressure once the refrigerant has been fully liquefied (condensed) at high pressure.

All refrigerants have a “critical pressure” and an associated “critical temperature” above which liquid and vapor phases cannot coexist. Above this critical point, the refrigerant will be a gas and its temperature will increase or decrease as heat is added or removed. For all conventional refrigerants, the critical pressure is so high that it is never exceeded in typical refrigeration cycles. For example, R404A is a common refrigerant used in refrigeration systems that has a critical pressure of 540.8 psia  6 with an associated critical temperature of 161.7 °F. However, CO 2 behaves differently, with a critical pressure of 1,072 psia associated with a much lower critical temperature of 87.8 °F. The refrigerant temperature must be somewhat higher than the ambient temperature in order to reject refrigeration cycle heat to the ambient environment. Ambient temperatures greater than 87.8 °F are common and the performance of many refrigeration and air conditioning systems are tested using a 95 °F ambient temperature, as indicated by the A test condition in AHRI 1250-2009 Section 5. At temperatures greater than the critical temperature, the CO 2 refrigerant is in a supercritical state ( i.e. a condition with pressure above the critical temperature) and heat is transferred to the environment. Since useful cooling is provided below the critical temperature, CO 2 cycles are said to be transcritical.

The transcritical nature of CO 2 generally requires more complex refrigeration cycle design to approach the efficiency of traditional refrigerants ( i.e., R404A, R407A, R448A, etc.) during operation in high temperature conditions. To increase efficiency and prevent overheating, transcritical booster systems introduce (or use) multiple stages of compression and intercooling. CO 2 is cooled in the gas cooler of a transcritical booster system, then expands through a high-pressure control valve and is delivered to a subcritical-pressure flash tank. In the flash tank, the refrigerant is in the subcritical phase and the liquid and vapor phases can be separated. A unit cooler in a CO 2 booster system would be supplied with liquid refrigerant from the flash tank via expansion valves where the refrigerant is evaporated. The evaporated refrigerant is subsequently compressed up to gas cooler pressure to complete the cycle (Hussmann, No. 5).

Hussmann also requests an interim waiver from the existing DOE test procedure. DOE will grant an interim waiver if it appears likely that the petition for waiver will be granted, and/or if DOE determines that it would be desirable for public policy reasons to grant immediate relief pending a determination of the petition for waiver. See 10 CFR 431.401(e)(2).

Based on the assertions in the petition, absent an interim waiver, the prescribed test procedure is not appropriate for Hussmann's CO 2 direct expansion unit coolers and the test conditions are not achievable, since CO 2 refrigerant has a critical temperature of 87.8 °F and the current DOE test procedure calls for a liquid inlet saturation temperature of 105 °F. The inability to achieve test conditions for the stated basic models would result in economic hardship from loss of sales stemming from the inability of the DOE test procedure to address the operating conditions of Hussmann's equipment.

EPCA requires that manufacturers use the applicable DOE test procedures when making representations about the energy consumption and energy consumption costs of covered equipment (42 U.S.C. 6314(d)). Consistency is important when making representations about the energy efficiency of equipment, including when demonstrating compliance with applicable DOE energy conservation standards. Pursuant to 10 CFR 431.401, and after consideration of public comments on the petition, DOE may establish in a subsequent Decision and Order an alternate test procedure for the basic models addressed by the Interim Waiver Order.

Hussmann seeks to test and rate specific CO 2 direct expansion unit cooler basic models with modifications to the DOE test procedure. Hussmann's suggested approach specifies using modified liquid inlet saturation and liquid inlet subcooling temperatures of 38 °F and 5 °F, respectively, for both walk-in refrigerator unit coolers and walk-in freezer unit coolers. Additionally, Hussmann recommends that because the subject units are used in transcritical CO 2 booster systems, the calculations in AHRI 1250-2009 section 7.9 should be used to determine the Annual Walk-in Efficiency Factor (“AWEF”) and net capacity for unit coolers matched to parallel rack systems as required under the DOE test procedure. This section of AHRI 1250-2009 is prescribed by the DOE test procedure for determining AWEF for all unit coolers tested alone (see 10 CFR part 431, subpart R, appendix C, section 3.3.1). Finally, Hussmann also suggested that AHRI 1250-2009 Table 17 (EER [Energy Efficiency Ratio] for Remote Commercial Refrigerated Display Merchandisers and Storage Cabinets) should be used to determine EER values and power consumption for the subject CO 2 direct expansion unit cooler systems as required under the DOE test procedure.

DOE has reviewed Hussmann's application, its suggested testing approach, industry materials regarding CO 2 transcritical booster systems, and Hussmann's consumer-facing materials, including websites and product specification sheets for the basic models listed in Hussmann's petition. Based on this review, the suggested testing approach appears to allow for the accurate measurement of energy efficiency of the specified basic models, while alleviating the testing issues associated with Hussmann's implementation of walk-in cooler and walk-in freezer testing for these basic models. Review of the CO 2 refrigeration market confirms that the test conditions of the testing approach suggested by Hussmann would be representative for operation of a unit cooler used in a transcritical CO 2 booster system. CO 2 that is cooled in the gas cooler of a transcritical booster system expands through a high-pressure control valve that delivers CO 2 to a subcritical-pressure flash tank, where liquid and vapor phases of the refrigerant are separated. The liquid is then split and the unit coolers receive the refrigerant at the same condition, consistent with the use of the same liquid inlet saturation temperature for both the medium- and low-temperature systems in Hussmann's suggested test approach. Calculations on other external CO 2 refrigeration system designs in the market indicate that the 38 °F liquid unit cooler inlet saturation temperature suggested by Hussmann is representative of CO 2 booster systems (Hussmann, No.5). Regarding use of the EER values in AHRI 1250-2009 Table 17 to determine the representative compressor power consumption for CO 2 unit cooler systems, research into the performance of different configurations of CO 2 booster systems shows that enhanced CO 2 cycles (like those used in transcritical booster systems) can match conventional refrigerants in average annual efficiency (Hussmann, No. 2). The findings from this research, along with the other collective factors previously noted, justifies the use of the EER values in AHRI 1250-2009 Table 17 for determining the power consumption for CO 2 booster system evaporators, despite these EER values being initially established for systems using conventional refrigerants. Consequently, DOE has determined that Hussmann's petition for waiver likely will be granted. Furthermore, DOE has determined that it is desirable for public policy reasons to grant Hussmann immediate relief pending a determination of the petition for waiver.

For the reasons stated, it is ordered that:

(1) Hussmann must test and rate the following CO 2 direct expansion unit cooler basic models with the alternate test procedure set forth in paragraph (2).

Basic Models for Which a Waiver is Requested:

(2) The Hussmann basic models identified in paragraph (1) of this Interim Waiver Order shall be tested according to the test procedure for walk-in cooler and walk-in freezer refrigeration systems prescribed by DOE at 10 CFR part 431, subpart R, appendix C (“Appendix C”), except that the liquid inlet saturation temperature test condition and liquid inlet subcooling temperature test condition shall be modified to 38 °F and 5 °F, respectively, for both walk-in refrigerator unit coolers and walk-in freezer unit coolers, as detailed below. All other requirements of Appendix C and DOE's regulations remain applicable.

In Appendix C, under section 3.1. General modifications: Test Conditions and Tolerances, revise section 3.1.5., to read as follows:

3.1.5. Tables 15 and 16 shall be modified to read as follows:

(3) Representations. Hussmann may not make representations about the energy efficiency of a basic model listed in paragraph (1) of this Interim Waiver Order for compliance, marketing, or other purposes unless the basic model has been tested in accordance with the provisions set forth in this alternate test procedure and such representations fairly disclose the results of such testing.

(4) This Interim Waiver Order shall remain in effect according to the provisions of 10 CFR 431.401.

(5) This Interim Waiver Order is issued on the condition that the statements and representations provided by Hussmann are valid. If Hussmann makes any modifications to the controls or configurations of a basic model subject to this Interim Waiver Order, such modifications will render the waiver invalid with respect to that basic model, and Hussmann will either be required to use the current Federal test method or submit a new application for a test procedure waiver. DOE may rescind or modify this waiver at any time if it determines the factual basis underlying the petition for the Interim Waiver Order is incorrect, or the results from the alternate test procedure are unrepresentative of the basic model's true energy consumption characteristics. 10 CFR 431.401(k)(1). Likewise, Hussmann may request that DOE rescind or modify the Interim Waiver Order if Hussmann discovers an error in the information provided to DOE as part of its petition, determines that the interim waiver is no longer needed, or for other appropriate reasons. 10 CFR 431.401(k)(2).

(6) Issuance of this Interim Waiver Order does not release Hussmann from the applicable requirements set forth at 10 CFR part 429.

DOE makes decisions on waivers and interim waivers for only those basic models specifically set out in the petition, not future models that may be manufactured by the petitioner. Hussmann may submit a new or amended petition for waiver and request for grant of interim waiver, as appropriate, for additional basic models of CO 2 direct expansion unit coolers. Alternatively, if appropriate, Hussmann may request that DOE extend the scope of a waiver or an interim waiver to include additional basic models employing the same technology as the basic model(s) set forth in the original petition consistent with 10 CFR 431.401(g).

This document of the Department of Energy was signed on December 28, 2020, by Daniel R. Simmons, Assistant Secretary for Energy Efficiency and Renewable Energy, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

Federal public transportation law (49 U.S.C. 5339(c)) authorizes FTA to award grants for low or no emission buses through a competitive process, as described in this notice. The Low-No Program provides funding to State and local governmental authorities for the purchase or lease of zero-emission and low-emission transit buses, including acquisition, construction, and leasing of required supporting facilities such as recharging, refueling, and maintenance facilities. FTA recognizes that a significant transformation is occurring in the transit bus industry, with the increasing availability of low and zero emission bus vehicles for transit revenue operations. This program supports FTA's strategic goals and objectives through the timely and efficient investment in public transportation. This program also supports the President's Build Back Better initiative to mobilize American ingenuity to build a modern infrastructure and an equitable, clean energy future. In addition, the Low-No Program and this NOFO will advance the goals of the President's January 20, 2021 Executive Order on Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis.

Federal public transportation law (49 U.S.C. 5338(a)(2)(M)) authorizes $55,000,000 in FY 2021 for the Low-No Program. The Consolidated Appropriations Act, 2021, appropriated an additional $125,000,000 for the Low-No Program, for a total of $180,000,000 for grants under this program. Additional funds made available prior to project selection may be allocated to eligible projects.

In FY 2020, the program received applications for 147 projects requesting a total of $513 million. Forty-one projects were funded at a total of $130 million. FTA may cap the amount a single recipient or State may receive as part of the selection process. In FY 2020, for example, the largest amount awarded to a single applicant was approximately $7 million and no State received more than 5.4 percent of the total funding available.

FTA will grant pre-award authority to incur costs for selected projects beginning on the date FY 2021 project selections are announced on FTA's website. Funds are available for obligation for three fiscal years after the fiscal year in which the competitive awards are announced. Funds are only available for projects that have not incurred costs prior to the announcement of project selections.

Eligible applicants include designated recipients, States, local governmental authorities, and Indian Tribes. Proposals for funding projects in rural (non-urbanized) areas may be submitted as part of a consolidated State proposal. To be considered eligible, applicants must be able to demonstrate the requisite legal, financial, and technical capabilities to receive and administer Federal funds under this program. States and other eligible applicants may submit consolidated proposals for projects in urbanized areas. Proposals may contain projects to be implemented by the recipient or its eligible subrecipients. Eligible subrecipients are entities that are otherwise eligible recipients under this program.

As permitted by the Consolidated Appropriations Act, 2021, applicants to the Low-No Program may submit applications that include partnerships with other entities that intend to participate in the implementation of the project, including, but not limited to, specific vehicle manufacturers, equipment vendors, owners or operators of related facilities, or project consultants. If an application that involves such a partnership is selected for funding, the competitive selection process will be deemed to satisfy the requirement for a competitive procurement under 49 U.S.C. 5325(a) for the named entities. Applicants are advised that any changes to the proposed partnership will require FTA written approval, must be consistent with the scope of the approved project, and may necessitate a competitive procurement.

The maximum Federal share for projects that involve leasing or acquiring transit buses (including clean fuel or alternative fuel vehicles) for purposes of complying with or maintaining compliance with the Clean Air Act is 85 percent of the net project cost.

The maximum Federal share for the cost of acquiring, installing, or constructing vehicle-related equipment or facilities (including clean fuel or alternative fuel vehicle-related equipment or facilities) for purposes of complying with or maintaining compliance with the Clean Air Act is 90 percent of the net project cost of such equipment or facilities that are attributable to compliance with the Clean Air Act. The award recipient must itemize the cost of specific, discrete, vehicle-related equipment associated with compliance with the Clean Air Act to be eligible for the maximum 90 percent Federal share for these costs.

The Federal share of the cost of other projects shall not exceed 80 percent.

Eligible sources of match include the following: cash from non-Government sources other than revenues from providing public transportation services; revenues derived from the sale of advertising and concessions; amounts received under a service agreement with a State or local social service agency or private social service organization; revenues generated from value capture financing mechanisms; funds from an undistributed cash surplus; replacement or depreciation cash fund or reserve; new capital; or in-kind contributions. Transportation development credits or in-kind match may be used for local match if identified and documented in the application.

Under the Low-No Program (49 U.S.C. 5339(c)), eligible projects include projects or programs of projects in an eligible area for: (1) Purchasing or leasing low or no emission buses; (2) acquiring low or no emission buses with a leased power source; (3) constructing or leasing facilities and related equipment for low or no emission buses; (4) constructing new public transportation facilities to accommodate low or no emission buses; (5) or rehabilitating or improving existing public transportation facilities to accommodate low or no emission buses (49 U.S.C. 5339(c)(1)(B)). As required by Federal public transportation law (49 U.S.C. 5339(c)(5)), FTA will only consider eligible projects relating to the acquisition or leasing of low or no emission buses or bus facilities that make greater reductions in energy consumption and harmful emissions than comparable standard buses or other low or no emission buses and are part of the recipient's long-term integrated fleet management plan.

A low or no emission bus is defined as a passenger vehicle used to provide public transportation that significantly reduces energy consumption or harmful emissions, including direct carbon emissions, when compared to a standard vehicle. The statutory definition includes zero emission transit buses, which are defined as buses that produce no direct carbon emissions and no particulate matter emissions under any and all possible operational modes and conditions. Examples of zero emission bus technologies include, but are not limited to, hydrogen fuel-cell buses and battery-electric buses. All new transit bus models must successfully complete FTA bus testing for production transit buses pursuant to FTA's Bus Testing regulation (49 CFR part 665) in order to be procured with funds awarded under the Low-No Program. All transit vehicles must be procured from certified transit vehicle manufacturers in accordance with the Disadvantaged Business Enterprise (DBE) regulations (49 CFR part 26). The development or deployment of prototype vehicles is not eligible for funding under the Low-No Program.

Recipients are permitted to use up to 0.5 percent of their requested grant award for workforce development activities eligible under Federal public transportation law (49 U.S.C. 5314(b)) and an additional 0.5 percent for costs associated with training at the National Transit Institute. Applicants must identify the proposed use of funds for these activities in the project proposal and identify them separately in the project budget.

If a single project proposal involves multiple public transportation providers, such as when an agency acquires vehicles that will be operated by another agency, the proposal must include a detailed statement regarding the role of each public transportation provider in the implementation of the project.

Applications must be submitted electronically through GRANTS.GOV . General information for submitting applications through GRANTS.GOV can be found at www.fta.dot.gov/howtoapply along with specific instructions for the forms and attachments required for submission. Mail and fax submissions of completed proposals will not be accepted. A complete proposal submission consists of two forms: The SF-424 Application for Federal Assistance (available at GRANTS.GOV ) and the supplemental form for the FY 2021 Low-No Program (downloaded from GRANTS.GOV or the FTA website at https://www.transit.dot.gov/funding/grants/lowno ). Failure to submit the information as requested can delay review or disqualify the application.

A complete proposal submission consists of two forms: (1) The SF-424 Application for Federal Assistance; and (2) the supplemental form for the FY 2021 Low-No Program. The supplemental form and any supporting documents must be attached to the “Attachments” section of the SF-424. The application must include responses to all sections of the SF-424 Application for Federal Assistance and the supplemental form, unless indicated as optional. The information on the supplemental form will be used to determine applicant and project eligibility for the program, and to evaluate the proposal against the selection criteria described in part E of this notice.

FTA will accept only one supplemental form per SF-424 submission. FTA encourages States and other applicants to consider submitting a single supplemental form that includes multiple activities to be evaluated as a consolidated proposal. If a State or other applicant chooses to submit separate proposals for individual consideration by FTA, each proposal must be submitted using a separate SF-424 and supplemental form.

Applicants may attach additional supporting information to the SF-424 submission, including but not limited to letters of support, project budgets, fleet status reports, or excerpts from relevant planning documents. Any supporting documentation must be described and referenced by file name in the appropriate response section of the supplemental form, or it may not be reviewed.

Information such as applicant name, Federal amount requested, local match amount, description of areas served, etc. may be requested in varying degrees of detail on both the SF-424 and supplemental form. Applicants must fill in all fields unless stated otherwise on the forms. If information is copied into the supplemental form from another source, applicants should verify that pasted text is fully captured on the supplemental form and has not been truncated by the character limits built into the form. Applicants should use both the “Check Package for Errors” and the “Validate Form” validation buttons on both forms to check all required fields on the forms, and ensure that the Federal and local amounts specified are consistent.

The SF-424 Application for Federal Assistance and the supplemental form will prompt applicants for the required information, including:

Each applicant is required to: (1) Be registered in SAM before submitting an application; (2) provide a valid unique entity identifier in its application; and (3) continue to maintain an active SAM registration with current information at all times during which the applicant has an active Federal award or an application or plan under consideration by FTA. These requirements do not apply if the applicant has an exemption approved by FTA under Federal grants and agreements law (2 CFR 25.110(d)). FTA may not make an award until the applicant has complied with all applicable unique entity identifier and SAM requirements. If an applicant has not fully complied with the requirements by the time FTA is ready to make an award, FTA may determine that the applicant is not qualified to receive an award and use that determination as a basis for making a Federal award to another applicant. Non-federal entities that have received a federal award are required to report certain civil, criminal, or administrative proceedings to SAM (currently the Federal Awardee Performance and Integrity Information System (FAPIIS)) to ensure registration information is current and comply with federal requirements. Applicants should reference 2 CFR 200.113, for more information.

All applicants must provide a unique entity identifier provided by SAM. Registration in SAM may take as little as 3-5 business days, but since there could be unexpected steps or delays (for example, if there is a need to obtain an Employer Identification Number), FTA recommends allowing ample time, up to several weeks, for completion of all steps. For additional information on obtaining a unique entity identifier, please visit www.sam.gov.

Project proposals must be submitted electronically through GRANTS.GOV by 11:59 p.m. Eastern time on April 12, 2021. GRANTS.GOV attaches a time stamp to each application at the time of submission. Proposals submitted after the deadline will only be considered under extraordinary circumstances not under the applicant's control. Mail and fax submissions will not be accepted.

Within 48 hours after submitting an electronic application, the applicant should receive an email message from GRANTS.GOV with confirmation of successful transmission to GRANTS.GOV . If a notice of failed validation or incomplete materials is received, the applicant must address the reason for the failed validation, as described in the email notice, and resubmit before the submission deadline. If making a resubmission for any reason, include all original attachments regardless of which attachments were updated and check the box on the supplemental form indicating this is a resubmission.

FTA urges applicants to submit applications at least 72 hours prior to the due date to allow time to receive the validation messages and to correct any problems that may have caused a rejection notification. GRANTS.GOV scheduled maintenance and outage times are announced on the GRANTS.GOV website. Deadlines will not be extended due to scheduled website maintenance.

Applicants are encouraged to begin the process of registration on the GRANTS.GOV site well in advance of the submission deadline. Registration is a multi-step process, which may take several weeks to complete before an application can be submitted. Registered applicants may still be required to take steps to keep their registration up to date before submissions can be made successfully: (1) Registration in SAM is renewed annually, and (2) persons making submissions on behalf of the Authorized Organization Representative (AOR) must be authorized in GRANTS.GOV by the AOR to make submissions.

Funds under this NOFO cannot be used to reimburse applicants for otherwise eligible expenses incurred prior to FTA award of a grant agreement until FTA has issued pre-award authority for selected projects. Refer to Section C.3., Eligible Projects, for information on activities that are allowable in this grant program. Allowable direct and indirect expenses must be consistent with the Governmentwide Uniform Administrative Requirements and Cost Principles (2 CFR part 200) and FTA Circular 5010.1E.

Applicants are encouraged to identify scaled funding options in case insufficient funding is available to fund a project at the full requested amount. If an applicant indicates that a project is scalable, the applicant must provide an appropriate minimum funding amount that will fund an eligible project that achieves the objectives of the program and meets all relevant program requirements. The applicant must provide a clear explanation of how the project budget would be affected by a reduced award. FTA may award a lesser amount regardless of whether a scalable option is provided.

All applications must be submitted via the GRANTS.GOV website. FTA does not accept applications on paper, by fax machine, email, or other means. For information on application submission requirements, please see Section D.1., Address to Request Application.

Projects will be evaluated primarily on the responses provided in the supplemental form. Additional information may be provided to support the responses; however, any additional documentation must be directly referenced on the supplemental form, including the file name where the additional information can be found. FTA will evaluate proposals for the Low-No Program based on the criteria described in this notice.

If an applicant is proposing to deploy autonomous vehicles or other innovative motor vehicle technology, the application should demonstrate that all vehicles will comply with applicable safety requirements, including those administered by the National Highway Traffic Safety Administration (NHTSA) and Federal Motor Carrier Safety Administration (FMCSA). Specifically, the application should show that vehicles acquired for the proposed project will comply with applicable Federal Motor Vehicle Safety Standards (FMVSS) and Federal Motor Carrier Safety Regulations (FMCSR). If the vehicles may not comply, the application should either (1) show that the vehicles and their proposed operations are within the scope of an exemption or waiver that has already been granted by NHTSA, FMCSA, or both agencies or (2) directly address whether the project will require exemptions or waivers from the FMVSS, FMCSR, or any other regulation and, if the project will require exemptions or waivers, present a plan for obtaining them.

Since the purpose of this program is to fund vehicles and facilities, applications will be evaluated based on the quality and extent to which they demonstrate how the proposed project will address an unmet need for capital investment in vehicles and/or supporting facilities. For example, an applicant may demonstrate that it requires additional or improved charging or maintenance facilities for low or no emission vehicles, that it intends to replace existing vehicles that have exceeded their minimum useful life, or that it requires additional vehicles to meet current ridership demands.

FTA will consider an applicant's responses to the following criteria when assessing the need for capital investment underlying the proposed project:

i. Consistency with Long-Term Fleet Management Plan: As required by Federal public transportation law (49 U.S.C. 5339(c)(5)(B)), all project proposals must demonstrate that they are part of the intended recipient's long-term integrated fleet management plan, as demonstrated through an existing transit asset management program, fleet procurement plan, or similarly documented program or policy. These plans must be attached to the application. FTA will evaluate the consistency of the proposed project with the applicant's long-term fleet management plan, as well as the applicant's previous experience with the relevant low or no emissions vehicle technologies.

ii. For low or no emission bus projects (replacement and/or or expansion): Applicants must provide information on the age, condition, and performance of the vehicles to be replaced by the proposed project. Vehicles to be replaced must have met their minimum useful life at the time of project completion. For service expansion requests, applicants must provide information on the proposed service expansion and the benefits for transit riders and the community from the new service. For all vehicle projects, the proposal must address whether the project conforms to FTA's spare ratio guidelines. Low or no emission vehicles funded under this program are not exempted from FTA's standard spare ratio requirements, which apply to and are calculated on the agency's entire fleet.

iii. For bus facility and equipment projects (replacement, rehabilitation, and/or expansion): Applicants must provide information on the age and condition of the asset to be rehabilitated or replaced relative to its minimum useful life.

Applicants must demonstrate how the proposed project will support the statutory requirements of the Low-No Program (See 49 U.S.C. 5339(c)(5)(A)). In particular, FTA will consider the quality and extent to which applications demonstrate how the proposed project will: (1) Reduce Energy Consumption; (2) Reduce Harmful Emissions; and (3) Reduce Direct Carbon Emissions.

i. Reduce Energy Consumption: Applicants must describe how the proposed project will reduce energy consumption. FTA will evaluate applications based on the degree to which the proposed technology reduces energy consumption as compared to more common vehicle propulsion technologies.

ii. Reduce Harmful Emissions: Applicants must demonstrate how the proposed vehicles or facility will reduce the emission of particulates that create local air pollution, which leads to local environmental health concerns, smog, and unhealthy ozone concentrations. FTA will evaluate the rate of particulate emissions by the proposed vehicles or vehicles to be supported by the proposed facility, compared to the emissions from the vehicles that will be replaced or moved to the spare fleet as a result of the proposed project, as well as comparable standard buses.

iii. Reduce Direct Carbon Emissions: Applicants should demonstrate how the proposed vehicles or facility will reduce emissions of greenhouse gases from transit vehicle operations. FTA will evaluate the rate of direct carbon emissions by the proposed vehicles or vehicles to be supported by the proposed facility, compared to the emissions from the vehicles that will be replaced or moved to the spare fleet as a result of the proposed project, as well as comparable standard buses.

Applicants must demonstrate how the proposed project is consistent with local and regional long-range planning documents and local government priorities. FTA will evaluate applications based on the quality and extent to which they assess whether the project is consistent with the transit priorities identified in the long-range plan; and/or contingency/illustrative projects included in that plan; or the locally developed human services public transportation coordinated plan. Applicants may submit copies of the relevant pages of such plans to support their application. FTA will consider how the project will support regional goals and applicants may submit support letters from local and regional planning organizations attesting to the consistency of the proposed project with these plans.

Evidence of additional local or regional prioritization may include letters of support for the project from local government officials, public agencies, and non-profit or private sector partners.

Applicants must identify the source of the local cost share and describe whether such funds are currently available for the project or will need to be secured if the project is selected for funding. FTA will consider the availability of the local cost share as evidence of local financial commitment to the project. Applicants should submit evidence of the availability of funds for the project; for example, by including a board resolution, letter of support from the State, or other documentation of the source of local funds such as a budget document highlighting the line item or section committing funds to the proposed project. FTA will note if an applicant proposes to use grant funds only for the incremental cost of new technologies over the cost of replacing vehicles with standard propulsion technologies.

FTA will rate projects higher if grant funds can be obligated within 12 months of selection and the project can be implemented within a reasonable time frame. In assessing when funds can be obligated, FTA will consider whether the project qualifies for a Categorical Exclusion (CE), or whether the required environmental work has been initiated or completed for projects that require an Environmental Assessment (EA) or Environmental Impact Statement (EIS) under the National Environmental Policy Act of 1969 (NEPA), as amended. As such, applicants should submit information describing the project's anticipated path and timeline through the environmental review process. The proposal must state when grant funds can be obligated and indicate the timeframe under which the Metropolitan Transportation Improvement Program (TIP) and/or Statewide Transportation Improvement Program (STIP) can be amended to include the proposed project.

In assessing whether the proposed implementation plans are reasonable and complete, FTA will review the proposed project implementation plan, including all necessary project milestones and the overall project timeline. For projects that will require formal coordination, approvals, or permits from other agencies or project partners, the applicant must demonstrate coordination with these organizations and their support for the project, such as through letters of support.

For project proposals that involve a partnership with a manufacturer, vendor, consultant, or other third party, applicants must identify by name any project partners, including, but not limited to, other transit agencies, bus manufacturers, owners or operators of related facilities, or any expert consultants. FTA will evaluate the experience and capacity of the named project partners to successfully implement the proposed project based on the partners' experience and qualifications. Applicants are advised to submit information on the partners' qualifications and experience as a part of the application. Entities involved in the project that are not named in the application will be required to be selected through a competitive procurement.

Applicants must demonstrate that they have the technical, legal, and financial capacity to undertake the project. FTA will review relevant oversight assessments and records to determine whether there are any outstanding legal, technical, or financial issues with the applicant that would affect the outcome of the proposed project.

In addition to other FTA staff that may review the proposals, a technical evaluation committee will evaluate proposals based on the published evaluation criteria. Members of the technical evaluation committee and other FTA staff may request additional information from applicants, if necessary. Based on the findings of the technical evaluation committee, the FTA Administrator will determine the final selection of projects for program funding. In determining the allocation of program funds, FTA may consider geographic diversity, diversity in the size of the transit systems receiving funding, and the applicant's receipt of other competitive awards. FTA may also consider capping the amount a single applicant may receive.

After applying the above criteria, in support of the President's January 20, 2021 Executive Order on Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis, the FTA Administrator will consider applications that may provide other air quality benefits as part of the application review. Applicants should identify any nonattainment or maintenance areas under the Clean Air Act in the proposed service area. Nonattainment or maintenance areas should be limited to the following applicable National Ambient Air Quality Standards criteria pollutants: Carbon monoxide, ozone, and particulate matter 2.5 and 10. The U.S. Environmental Protection Agency's Green Book (available at https://www.epa.gov/green-book ) is a publicly-available resource for nonattainment and maintenance area data. This consideration will further the goals of the Executive Order, including the goal to prioritize environment justice (EJ).

In addition, FTA will consider benefits to EJ communities when reviewing applications received under this program. Applicants should identify any EJ populations located within the proposed service area and describe anticipated benefits to that population(s) should the applicant receive a grant under this program. A formal EJ analysis that is typically included in transportation planning or environmental reviews is not requested.

Additionally, the FTA Administrator will consider applications that include a funding request for workforce development activities that improve the technical expertise of America's transit workers.

Prior to making an award, FTA is required to review and consider any information about the applicant that is in the Federal Award Performance and Integrity Information System accessible through SAM. An applicant may review and comment on any information about itself that a Federal awarding agency previously entered. FTA will consider any comments by the applicant, in addition to the other information in the designated integrity and performance system, in making a judgment about the applicant's integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in the Office of Management and Budget's Uniform Requirements for Federal Awards (2 CFR 200.205).

FTA will announce the final project selections on the FTA website. Recipients should contact their FTA Regional Offices for additional information regarding allocations for projects under the Low-No Program. At the time the project selections are announced, FTA will extend pre-award authority for the selected projects. There is no blanket pre-award authority for these projects before announcement.

Funds under the Low-No Program are available to States, designated recipients, local governmental authorities, and Indian Tribes. There is no minimum or maximum grant award amount. However, FTA intends to fund as many meritorious projects as possible. Only proposals from eligible recipients for eligible activities will be considered for funding. Due to funding limitations, applicants that are selected for funding may receive less than the amount originally requested. In those cases, applicants must be able to demonstrate that the proposed projects are still viable and can be completed with the amount awarded.

FTA will issue specific guidance to recipients regarding pre-award authority at the time of selection. FTA does not provide pre-award authority for competitive funds until projects are selected, and even then, there are Federal requirements that must be met before costs are incurred. For more information about FTA's policy on pre-award authority, please see the most recent Apportionment Notice at https://www.transit.dot.gov.

If selected, awardees will apply for a grant through FTA's Transit Award Management System (TrAMS). All Low-No Program recipients are subject to the grant requirements of the Urbanized Area Formula Grant program (49 U.S.C. 5307), including those of FTA Circular “Urbanized Area Formula Program: Program Guidance and Application Instructions” (FTA C.9030.1E). All recipients must also follow the Award Management Requirements (FTA C.5010.1) and the labor protections required by Federal public transportation law (49 U.S.C. 5333(b)). Technical assistance regarding these requirements is available from each FTA regional office.

FTA requires that all capital procurements meet FTA's Buy America requirements (49 U.S.C. 5323(j) and 49 CFR part 661), which require that all iron, steel, or manufactured products be produced in the United States. Federal public transportation law provided for a phased increase in the domestic content for rolling stock between FY 2016 and FY 2020. For FY 2020 and beyond, the cost of components and subcomponents produced in the United States must be more than 70 percent of the cost of all components. There is no change to the requirement that final assembly of rolling stock must occur in the United States. FTA issued guidance on the implementation of the phased increase in domestic content on September 1, 2016 (81 FR 60278). Applicants should read the policy guidance carefully to determine the applicable domestic content requirement for their project. Any proposal that will require a waiver must identify in the application the items for which a waiver will be sought. Applicants should not proceed with the expectation that waivers will be granted.

FTA requires that its recipients receiving planning, capital, and/or operating assistance that will award prime contracts exceeding $250,000 in FTA funds in a Federal fiscal year comply with Department of Transportation Disadvantaged Business Enterprise (DBE) program regulations (49 CFR part 26). Applicants should expect to include any funds awarded, excluding those to be used for vehicle procurements, in setting their overall DBE goal. Note, however, that projects including vehicle procurements remain subject to the DBE program regulations. The rule requires that, prior to bidding on any FTA-assisted vehicle procurement, entities that manufacture vehicles, or perform post-production alterations or retrofitting, must submit a DBE program plan and goal methodology to FTA. Further, to the extent that a vehicle remanufacturer is responding to a solicitation for new or remanufactured vehicles with a vehicle to which the remanufacturer has provided post-production alterations or retrofitting ( e.g., replacing major components such as an engine to provide a “like new” vehicle), the vehicle remanufacturer is considered a transit vehicle manufacturer and must also comply with the DBE regulations.

FTA will then issue a transit vehicle manufacturer (TVM) concurrence/certification letter. Grant recipients must verify each entity's compliance with these requirements before accepting its bid. A list of compliant, certified TVMs is posted on FTA's web page at https://www.transit.dot.gov/regulations-and-guidance/civil-rights-ada/eligible-transit-vehicle-manufacturers. Please note that this list is nonexclusive, and recipients must contact FTA before accepting bids from entities not listed on this web-posting. Recipients may also establish project-specific DBE goals for vehicle procurements. FTA will provide additional guidance as grants are awarded. For more information on DBE requirements, please contact Scheryl Portee, Office of the Chief Counsel, 202-366-0840, email: scheryl.portee@dot.gov.

FTA encourages applicants to notify the appropriate State Departments of Transportation and metropolitan planning organizations in areas likely to be served by the project funds made available under these initiatives and programs. Selected projects must be incorporated into the long-range plans and transportation improvement programs of States and metropolitan areas before they are eligible for FTA funding. As described under the evaluation criteria, FTA may consider whether a project is consistent with or already included in these plans when evaluating a project.

The applicant assures that it will comply with all applicable Federal statutes, regulations, executive orders, directives, FTA circulars, and other Federal administrative requirements in carrying out any project supported by the FTA grant. The applicant acknowledges that it is under a continuing obligation to comply with the terms and conditions of the grant agreement issued for its project with FTA. The applicant understands that Federal laws, regulations, policies, and administrative practices might be modified from time to time and may affect the implementation of the project. The applicant agrees that the most recent Federal requirements will apply to the project, unless FTA issues a written determination otherwise. The applicant must submit the Certifications and Assurances before receiving a grant if it does not have current certifications on file.

Post-award reporting requirements include the electronic submission of Federal Financial Reports and Milestone Progress Reports in FTA's electronic grants management system. Recipients of funds made available through this NOFO are also required to regularly submit data to the National Transit Database. Applicant should include any goals, targets, and indicators referenced in their application in the Executive Summary of the TrAMS application.

As part of completing the annual certifications and assurances required of FTA grant recipients, a successful applicant must report on the suspension or debarment status of itself and its principals. If the award recipient's active grants, cooperative agreements, and procurement contracts from all Federal awarding agencies exceeds $10,000,000 for any period of time during the period of performance of an award made pursuant to this Notice, the recipient must comply with the Recipient Integrity and Performance Matters reporting requirements described in Appendix XII to 2 CFR part 200.

For further information concerning this notice, please contact the Low-No Program Manager, Amy Volz, by phone at 202-366-7484, or by email at amy.volz@dot.gov. A TDD is available for individuals who are deaf or hard of hearing at 800-877-8339. In addition, FTA will post answers to questions and requests for clarifications on FTA's website at https://www.transit.dot.gov/funding/grants/lowno. To ensure applicants receive accurate information about eligibility or the program, applicants are encouraged to contact FTA directly, rather than through intermediaries or third parties, with questions. FTA staff may also conduct briefings on the FY 2021 competitive grants selection and award process upon request.

This program is not subject to Executive Order 12372, “Intergovernmental Review of Federal Programs.” FTA will consider applications for funding only from eligible recipients for eligible projects listed in Section C. Complete applications must be submitted through GRANTS.GOV by 11:59 p.m. Eastern time on April 12, 2021.

For issues with GRANTS.GOV , please contact GRANTS.GOV by phone at 1-800-518-4726 or by email at support@grants.gov. Contact information for FTA's regional offices can be found on FTA's website at www.fta.dot.gov.

The PRA, 44 U.S.C. 3501-3520, and its implementing regulations, 5 CFR part 1320, require Federal agencies to issue two notices seeking public comment on information collection activities before OMB may approve paperwork packages. See 44 U.S.C. 3506, 3507; 5 CFR 1320.8 through 1320.12. On December 10, 2020, FRA published a 60-day notice in the Federal Register soliciting comment on the ICR for which it is now seeking OMB approval. See 85 FR 79559. FRA received no comments in response to this 60-day notice.

Before OMB decides whether to approve the proposed collection of information, it must provide 30 days for public comment. Federal law requires OMB to approve or disapprove paperwork packages between 30 and 60 days after the 30-day notice is published. 44 U.S.C. 3507(b)-(c); 5 CFR 1320.12(b); see also 60 FR 44978, 44983, Aug. 29, 1995. OMB believes the 30-day notice informs the regulated community to file relevant comments and affords the agency adequate time to digest public comments before it renders a decision. 60 FR 44983, Aug. 29, 1995. Therefore, respondents should submit their respective comments to OMB within 30 days of publication to best ensure having their full effect.

Comments are invited on the following ICR regarding: (1) Whether the information collection activities are necessary for FRA to properly execute its functions, including whether the information will have practical utility; (2) the accuracy of FRA's estimates of the burden of the information collection activities, including the validity of the methodology and assumptions used to determine the estimates; (3) ways for FRA to enhance the quality, utility, and clarity of the information being collected; and (4) ways to minimize the burden of information collection activities on the public, including the use of automated collection techniques or other forms of information technology.

The summary below describes the ICR that FRA will submit for OMB clearance as the PRA requires:

Title: Metrics and Minimum Standards for Intercity Passenger Rail Service.

OMB Control Number: 2130-0632. 1

Abstract: On October 16, 2008, President George W. Bush signed into law the Passenger Rail Investment and Improvement Act of 2008, Public Law 110-432, 122 Stat. 4907 (PRIIA). Section 207 of PRIIA requires FRA and Amtrak jointly to develop new or improved metrics and minimum standards for measuring the performance and service quality of intercity passenger train operations, including cost recovery, on-time performance and minutes of delay, ridership, on-board services, stations, facilities, equipment, and other services

Section 207 also calls for consultation with the Surface Transportation Board, rail carriers over whose rail lines Amtrak trains operate, States, Amtrak employees, and groups representing Amtrak passengers, as appropriate.

Section 207 further provides that the metrics, at a minimum, must include: the percentage of avoidable and fully allocated operating costs covered by passenger revenues on each route; ridership per train mile operated; measures of on-time performance and delays incurred by intercity passenger trains on the rail lines of each rail carrier; and, for long-distance routes, measures of connectivity with other routes in all regions currently receiving Amtrak service and the transportation needs of communities and populations that are not well-served by other forms of intercity transportation.

Section 207 also provides that the FRA Administrator must collect the necessary data and publish a quarterly report on the performance and service quality of intercity passenger train operations, including Amtrak's cost recovery, ridership, on-time performance and minutes of delay, causes of delay, on-board services, stations, facilities, equipment, and other services.

In connection with the Congressional mandate, FRA's Metrics and Minimum Standards for Intercity Passenger Rail Service final rule (49 CFR part 273) sets forth a number of metrics that must be collected. 85 FR 72971. On November 23, 2020, FRA published a request for emergency processing of a collection of information because FRA could not reasonably comply with normal clearance procedures to timely collect ridership data metrics and certified schedule metrics as required by 49 CFR 273.5(b) and (c). 85 FR 74783. This ICR request covers all metrics set forth in the final rule, including those covered by the emergency clearance.

Type of Request: Revision to a currently approved information collection.

Affected Public: Amtrak.

Form(s): N/A.

Respondent Universe:   2 1 (Amtrak).

Frequency of Submission: Varied.

Total Estimated Annual Responses: 117.

Total Estimated Annual Burden:   3 507 hours.

Total Estimated Annual Burden Hour Dollar Cost Equivalent: $66,365.00.

Under 44 U.S.C. 3507(a) and 5 CFR 1320.5(b) and 1320.8(b)(3)(vi), FRA informs all interested parties that a respondent is not required to respond to, conduct or sponsor a collection of information unless it displays a currently valid OMB control number.

The PRA, 44 U.S.C. 3501-3520, and its implementing regulations, 5 CFR part 1320, require Federal agencies to provide 60-days' notice to the public to allow comment on information collection activities before seeking OMB approval of the activities. See 44 U.S.C. 3506, 3507; 5 CFR 1320.8 through 1320.12. Specifically, FRA invites interested parties to comment on the following ICR regarding: (1) Whether the information collection activities are necessary for FRA to properly execute its functions, including whether the activities will have practical utility; (2) the accuracy of FRA's estimates of the burden of the information collection activities, including the validity of the methodology and assumptions used to determine the estimates; (3) ways for FRA to enhance the quality, utility, and clarity of the information being collected; and (4) ways for FRA to minimize the burden of information collection activities on the public, including the use of automated collection techniques or other forms of information technology. See 44 U.S.C. 3506(c)(2)(A); 5 CFR 1320.8(d)(1).

FRA believes that soliciting public comment may reduce the administrative and paperwork burdens associated with the collection of information that Federal regulations mandate. In summary, FRA reasons that comments received will advance three objectives: (1) Reduce reporting burdens; (2) organize information collection requirements in a “user-friendly” format to improve the use of such information; and (3) accurately assess the resources expended to retrieve and produce information requested. See 44 U.S.C. 3501.

The summary below describes the ICR that FRA will submit for OMB clearance as the PRA requires:

Title: Accident/Incident Reporting and Recordkeeping.

OMB Control Number: 2130-0500.

Abstract: The railroad accident/incident reporting regulations in 49 CFR part 225 require railroads to submit monthly reports summarizing collisions, derailments, and certain other accidents/incidents involving damages above a periodically revised dollar threshold, as well as certain injuries to passengers, employees, and other persons on railroad property. As the reporting requirements and the information needed regarding each category of accident/incident are unique, a different form is used for each category.

Type of Request: Extension without change (with changes in estimates) of a currently approved collection.

Affected Public: Businesses.

Form(s): FRA F 6180.54; .55; .55a; .56; .57; .78; .81; .97; .98; .107; .150.

Respondent Universe: 765 railroads.

Frequency of Submission: On occasion.

Reporting Burden:

Total Estimated Annual Responses: 89,057.

Total Estimated Annual Burden: 35,845 hours.

Total Estimated Annual Burden Hour Dollar Cost Equivalent: $2,775,067.

Under 44 U.S.C. 3507(a) and 5 CFR 1320.5(b) and 1320.8(b)(3)(vi), FRA informs all interested parties that a respondent is not required to respond to, conduct, or sponsor a collection of information that does not display a currently valid OMB control number.

Title 49 U.S.C. 47105(f) provides that the sponsor of an airport for which entitlement funds are apportioned shall notify the Secretary, by such time and in a form as prescribed by the Secretary, of the airport sponsor's intent to submit a grant application for its available entitlement funds. Therefore, the FAA is hereby notifying such airport sponsors of the steps required to ensure that the FAA has sufficient time to carry over and convert remaining entitlement funds.

The AIP grant program is operating under the requirements of Public Law 115-254, the “FAA Reauthorization Act of 2018,” enacted on October 5, 2018, which authorizes the AIP through September 30, 2023, and Public Law 116-260, the “Transportation, Housing and Urban Development, and Related Agencies Appropriations Act, 2021,” which appropriates FY 2021 funds for the AIP through September 30, 2021. In accordance with legislation enacted as of the date of this notice, the AIP has approximately $2.3 billion of entitlement funds available through September 30, 2021.

This notice applies only to those airports that have entitlement funds apportioned to them, except those nonprimary airports located in designated Block Grant States.

An airport sponsor intending to apply for any of its available entitlement funds, including those unused but still available in accordance with 49 U.S.C. 47117 from prior years, must notify the FAA of its intent to submit a grant application by 12 p.m. prevailing local time on Monday, March 15, 2021.

This notice must be in writing and address all entitlement funds available to date for FY 2021, including those entitlement funds not obligated from prior years. These notifications are critical to ensure efficient planning and administration of the AIP. The final grant application deadline is Monday, May 3, 2021. The final grant application funding requests should be based on bids, not estimates. The FAA will carryover the remainder of available entitlement funds after the above date as prescribed under 49 U.S.C. 47117. These funds will not be available again to the airport sponsor until the beginning of FY 2022. Dates are subject to possible adjustment based on future legislation. As of the publication of this notice, appropriations for the FAA expire on September 30, 2021, and authorization legislation for the FAA expires on September 30, 2023.

The FAA has determined this process and deadline will expedite and facilitate the FY 2021 grant-making process.

The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

Title of Collection: Early Childhood Longitudinal Study, Kindergarten Class of 2022-23 (ECLS-K:2023) Study Delay.

OMB Control Number: 1850-0750.

Type of Review: No material or nonsubstantive change to a currently approved information collection.

Respondents/Affected Public: Individuals or households.

Total Estimated Number of Annual Responses: 46,033.

Total Estimated Number of Annual Burden Hours: 8,655.

Abstract: The Early Childhood Longitudinal Study (ECLS) program, conducted by the National Center for Education Statistics (NCES) within the Institute of Education Sciences (IES) of the U.S. Department of Education (ED), draws together information from multiple sources to provide rich, descriptive data on child development, early learning, and school progress. The ECLS program studies deliver national data on children's status at birth and at various points thereafter; children's transitions to nonparental care, early care and education programs, and school; and children's experiences and growth through the elementary grades. The Early Childhood Longitudinal Study, Kindergarten Class of 2022-23 (ECLS-K:2023) is the fourth cohort in the series of early childhood longitudinal studies. The study will advance research in child development and early learning by providing a detailed and comprehensive source of current information on children's early learning and development, transitions into kindergarten and beyond, and progress through school. Collecting parent data beginning in preschool will enable the study to measure influences on children's development before entry into formal schooling, including children's home environments and access to early care and education. The request to conduct a field test of the ECLS-K:2023 preschool data collection activities from January through October 2020, to field test the preschool data collection materials and procedures, was approved in November 2019 (OMB#1850-0750 v.19), with change requests approved in January and July 2020 (OMB #1850-0750 v.20-21). This request is to notify OMB and the public that, due to concerns that as a result of the ongoing coronavirus pandemic the ECLS field test and national study recruitment activities that had been planned for 2021 may not be successful, NCES has decided to postpone the study by one year, and the study will now be the Early Childhood Longitudinal Study, Kindergarten Class of 2023-24 (ECLS-K:2024). The kindergarten-first grade field test will be moved from fall 2021 to fall 2022. The national study data collections will also be delayed a year, beginning in 2023. The third-fifth grade field test will be moved from fall 2025 to fall 2026. No other planned procedures or features of the study will change. Approval for the fall 2022 kindergarten-first grade field test and national study recruitment will be requested in a separate submission later in 2021.

This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action.

The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2018-0014, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

EPA is rescinding cancellation orders for seven triadimefon product registrations issued in two Federal Register Notices, a January 12, 2021 Federal Register Notice (86 FR 2415) (FRL-10017-33) and an August 25, 2020 Federal Register Notice (85 FR 52347) (FRL-10013-65) to the extent they are applicable to Bayer's triadimefon products. Based on the current status of the triadimefon review, and given the low frequency and severity of incidents, EPA is rescinding these voluntary cancellations as requested by Bayer. This order rescinds the cancellation orders for Bayer's triadimefon registrations listed in Table 1 of this unit.

This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action.

The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2009-0308, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001.

Due to public health concerns related to COVID-19, the EPA Docket Center (EPA/DC) and Reading Room is closed to visitors with limited exceptions. The staff continues to provide remote customer service via email, phone, and webform. For the latest status information on EPA/DC services and docket access, visit http://www.epa.gov/dockets.

This notice announces the amendments to delete the uses, as requested by the registrant, for products registered under FIFRA section 3 (7 U.S.C. 136a). The registration is listed in Table 1 of this unit.

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

During the 30-day public comment period provided, EPA received no comments in response to the August 6, 2020 Federal Register notice announcing the Agency's receipt of the request for voluntary deletion of uses for the products listed in Table 1 of Unit II.

Pursuant to FIFRA section 6(f) (7 U.S.C. 136d(f)), EPA hereby approves the requested amendments to terminate uses of TCVP for the registration identified in Table 1 of Unit II. Accordingly, the Agency hereby orders that the product registrations identified in Table 1 of Unit II. are amended to terminate uses on dogs, cats and in kennels and dog houses. The effective date of the amendments to terminate affected uses that are the subject of this notice is February 18, 2021. Any distribution, sale, or use of existing stocks of the products identified in Table 1 of Unit II. in a manner inconsistent with any of the provisions for disposition of existing stocks set forth in Unit VI. will be a violation of FIFRA.

Section 6(f)(1) of FIFRA (7 U.S.C. 136d(f)(1)) provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be canceled or amended to terminate one or more uses. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any such request in the Federal Register . Thereafter, following the public comment period, the EPA Administrator may approve such a request. The notice of receipt for this action was published for comment in the Federal Register of August 6, 2020 [(volume 85 number 152) (FRL-10012-80)]. The comment period closed on September 8, 2020.

Existing stocks are those stocks of registered pesticide products that are currently in the United States and that were packaged, labeled, and released for shipment prior to the effective date of the cancellation action. The existing stocks provisions for the products subject to this order are as follows.

Chem-Tech may not “release for shipment,” as that term is defined by 40 CFR 152.3, any product under EPA Reg. No. 47000-123 as of February 18, 2021 and may not sell or distribute existing stocks except for export consistent with FIFRA section 17 (7 U.S.C. 136o) or for proper disposal. Chem-Tech may sell or distribute existing stocks of EPA Reg. No. 47000-123 until exhausted.

Persons other than the registrants may sell, distribute, or use existing stocks of canceled products until supplies are exhausted, provided that such sale, distribution, or use is consistent with the terms of the previously approved labeling on, or that accompanied, the canceled products.

On October 13, 2005, the final Cross-Media Electronic Reporting Rule (CROMERR) was published in the Federal Register (70 FR 59848) and codified as part 3 of title 40 of the CFR. CROMERR establishes electronic reporting as an acceptable regulatory alternative to paper reporting and establishes requirements to assure that electronic documents are as legally dependable as their paper counterparts. Subpart D of CROMERR requires that state, tribal or local government agencies that receive, or wish to begin receiving, electronic reports under their EPA-authorized programs must apply to EPA for a revision or modification of those programs and obtain EPA approval. Subpart D provides standards for such approvals based on consideration of the electronic document receiving systems that the state, tribe, or local government will use to implement the electronic reporting. Additionally, § 3.1000(b) through (e) of 40 CFR part 3, subpart D provides special procedures for program revisions and modifications to allow electronic reporting, to be used at the option of the state, tribe or local government in place of procedures available under existing program-specific authorization regulations. An application submitted under the subpart D procedures must show that the state, tribe or local government has sufficient legal authority to implement the electronic reporting components of the programs covered by the application and will use electronic document receiving systems that meet the applicable subpart D requirements.

On September 17, 2020, the New Hampshire Department of Environmental Services (NHDES) submitted an application titled Compliance Monitoring Data Portal for revisions/modifications to its EPA-approved programs under title 40 CFR to allow new electronic reporting. EPA reviewed NHDES's request to revise/modify its EPA-authorized programs and, based on this review, EPA determined that the application met the standards for approval of authorized program revisions/modifications set out in 40 CFR part 3, subpart D. In accordance with 40 CFR 3.1000(d), this notice of EPA's decision to approve New Hampshire's request to revise its Part 142—National Primary Drinking Water Regulations Implementation program to allow electronic reporting under 40 CFR part 141 is being published in the Federal Register .

NHDES was notified of EPA's determination to approve its application with respect to the authorized programs listed above.

Also, in today's notice, EPA is informing interested persons that they may request a public hearing on EPA's action to approve the State of New Hampshire's request to revise its authorized public water system program under 40 CFR part 142, in accordance with 40 CFR 3.1000(f). Requests for a hearing must be submitted to EPA within 30 days of publication of today's Federal Register notice. Such requests should include the following information:

(1) The name, address and telephone number of the individual, organization or other entity requesting a hearing;

(2) A brief statement of the requesting person's interest in EPA's determination, a brief explanation as to why EPA should hold a hearing, and any other information that the requesting person wants EPA to consider when determining whether to grant the request;

(3) The signature of the individual making the request, or, if the request is made on behalf of an organization or other entity, the signature of a responsible official of the organization or other entity.

In the event a hearing is requested and granted, EPA will provide notice of the hearing in the Federal Register not less than 15 days prior to the scheduled hearing date. Frivolous or insubstantial requests for hearing may be denied by EPA. Following such a public hearing, EPA will review the record of the hearing and issue an order either affirming today's determination or rescinding such determination. If no timely request for a hearing is received and granted, EPA's approval of the State of New Hampshire's request to revise its part 142—National Primary Drinking Water Regulations Implementation program to allow electronic reporting will become effective 30 days after today's notice is published, pursuant to CROMERR section 3.1000(f)(4).

Intellectual Property

The following represents the intellectual property to be licensed under the prospective agreement:

(A) U.S. Provisional Patent Application 62/006,313 entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-US-01], PCT Patent Application PCT/US2015/033473 entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-PCT-02], Australian Patent 2015270912 entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-AU-03], Canadian Patent Application 2951045 entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-CA-04], Chinese Patent Application 201580033802.5 entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-CN-05], European Patent 3149044 entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-EP-06] (validated in Germany [HHS Ref. E-042-2014-0-DE-19], Spain [HHS Ref. E-042-2014-0-ES-20], France [HHS Ref. E-042-2014-0-FR-21], the 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 lodged in Hong Kong [E-042-2014-0-HK-16]), Israeli Patent Application 249305 entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-IL-07], Indian Patent Application 291647041047 entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-IN-08], Japanese Patent Application 2016-571017 entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-JP-09], South Korean Patent Application 2016-7036828 entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-KR-10], Mexican Patent Application MX/a/2016/015834 entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-MX-11], New Zealand Patent Application 727167 entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-NZ-12], Saudi Arabian Patent Application 516380406 entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-SA-13], Singaporean Patent Application 11201609960Q entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-SG-14], United States Patent 10,287,350 entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-US-15], United States Patent Application 16/360,281 entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-US-17], New Zealand Patent Application 764530 entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-NZ-18], European Patent Application 20197459.9 entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-EP-25], Australian Patent Application 2020267211 entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-AU-26], and Japanese Patent Application XXX entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-JP-27], and all continuing U.S. and foreign patents/patent applications for the technology family.

The patent rights in these inventions have been assigned and/or exclusively licensed to the government of the United States of America.

The prospective exclusive license territory may be worldwide and the field of use may be limited to the following:

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

This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will be royalty bearing, and the prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the National Cancer Institute receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.

In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a completed license application, will not be treated confidentially, and may be made publicly available.

License applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information in these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552.

The components of this information request include:

1. Legal Service Provider List for UAC in ORR Care (Form LRG-5/5s): This instrument is provided to UAC by their case manager. The instrument contains a list of legal services providers available to UAC. UAC initial and sign the instrument upon admission and release of ORR custody to acknowledge receipt of documents contained in ORR's Legal Resource Guide. This form was previously approved under OMB Number 0970-0498 and is being reinstated without changes under this new OMB number.

2. Request for a Flores Bond Hearing (Form LRG-7/7s): This instrument is provided to UAC placed by their case manager. The instrument is always provided to UAC placed in a restrictive setting (secure, staff secure, and residential treatment center facilities) and to UAC placed in other types of facilities upon request. UAC may use this instrument to request or withdraw a request for a Flores bond hearing.

3. Motion to Request a Bond Hearing—Secure or Staff Secure Custody (Form LRG-8A): This instrument is completed by case managers upon receipt of a Request for a Flores Bond Hearing for a UAC in secure or staff secure custody and provided to ORR. ORR files the motion with the local immigration court.

4. Motion to Request a Bond Hearing—Non-Secure Custody (Form LRG-8B): This instrument is completed by case managers upon receipt of a Request for a Flores Bond Hearing for a UAC placed in a non-secure program ( e.g., shelter, foster care) and provided to ORR. ORR files the motion with the local immigration court.

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

6. Specific Consent Request Case Summary (Form L-2): This instrument is completed by ORR Federal Field Specialists (FFS) when ORR receives a request for specific consent. FFS provide case information that will allow the ORR Director to make an informed decision on whether to grant specific consent.

7. Notice of Attorney Representation (Form L-3): This instrument is completed by attorneys of record for UAC to notify ORR of the purpose of legal representation and the representation timeframe. ORR uses this instrument to ensure that case updates are provided to attorneys of record. This instrument may also be used by attorneys of record when requesting a copy of their client's case file.

8. UAC Legal Information (Form L-4): This instrument is used by case managers to document, as applicable, referrals to the Office of Trafficking in Persons; meetings between the UAC and their legal service provider or attorney of record; the provision of ORR's Legal Resource Guide to the UAC; information about the UAC's legal service provider or attorney of record; immigration and administrative hearings; and provision of the Notice of Placement in a Restrictive Setting to the UAC. The instrument also includes an area to upload legal documents.

9. Legal Service Provider Record (Form L-6): This instrument is used by case managers to create a record containing certain information and documents that ORR makes accessible to ORR-funded legal service providers without requiring a formal records request.

10. Motion for Change of Venue (Form L-7): This instrument is used by case managers to file a motion for change of venue when a UAC is transferred or discharged to a new immigration court jurisdiction.

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

Respondents: ORR grantee and contractor staff; UAC; parents/legal guardians of UAC; attorneys of record; and legal service providers.

This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES ).

Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice.

1. Type of Information Collection Request: Reinstatement without change of a currently approved collection; Title of Information Collection: Electronic Submission of Medicare Graduate Medical Education (GME) Affiliation Agreements; Use: Existing regulations at § 413.75(b) permit hospitals that share residents to elect to form a Medicare GME affiliated group if they are in the same or contiguous urban or rural areas, if they are under common ownership, or if they are jointly listed as program sponsors or major participating institutions in the same program by the accrediting agency. The purpose of a Medicare GME affiliated group is to provide flexibility to hospitals in structuring rotations under an aggregate full time equivalent (FTE) resident cap when they share residents. The existing regulations at § 413.79(f)(1) specify that each hospital in a Medicare GME affiliated group must submit a Medicare GME affiliation agreement (as defined under § 413.75(b)) to the Medicare Administrative Contractor (MAC) servicing the hospital and send a copy to the Centers for Medicare and Medicaid Services' (CMS) Central Office, no later than July 1 of the residency program year during which the Medicare GME affiliation agreement will be in effect.

CMS will use the information contained in electronic affiliation agreements as documentation of the existence of Medicare GME affiliations, and to verify that the affiliations being formed by teaching hospitals for the purposes of sharing their Medicare GME FTE cap slots are valid according to CMS regulations. CMS will also use these affiliation agreements as reference materials when potential issues involving specific affiliations arise. While we have used hard copies of affiliation agreements for those same purposes in the past, we implemented this electronic submission process in order to expedite and ease the process of retrieving, analyzing and evaluating affiliation agreements. Form Number: CMS-10326 (OMB control number: 0938-1111); Frequency: Annually; Affected Public: Private Sector, Business or other for profits, Not for profit institutions; Number of Respondents: 125; Total Annual Responses: 125; Total Annual Hours: 166. (For policy questions regarding this collection contact Shevi Marciano at 410-786-2875.)

Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

This information collection supports Agency regulations. Under section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360), any person owning or operating an establishment that manufactures, prepares, propagates, compounds, or processes a drug or device must register with the Secretary of Health and Human Services, on or before December 31 of each year, his or her name, places of business, and all such establishments, among other information and must submit, a listing of all drug and device products manufactured, prepared, propagated, compounded, or processed by him or her for commercial distribution, among other information. In 21 CFR part 607, FDA has issued regulations implementing these requirements for manufacturers of human blood and blood products.

The regulations set forth procedures and requirements pertaining to establishment registration and product listing for manufacturers of human blood and blood products and licensed devices, including initial registration, annual registration, product listing updates, and waiver requests. Owners or operators of certain establishments that engage in the manufacture of blood products shall register and submit a list of every blood product in commercial distribution (21 CFR 607.20(a)). Initial and subsequent registrations and product listings must be submitted electronically through FDA's Center for Biologics Evaluation and Research (CBER) Blood Establishment Registration and Product Listing system, or any future superseding electronic system, unless FDA has granted a request for waiver of this requirement prior to the date on which the information is due (21 CFR 607.22(a)). Waiver requests must be submitted in writing and must include, among other information, the specific reasons why electronic submission is not reasonable for the registrant (21 CFR 607.22(b)). Establishment registration and product listing information assists FDA in its inspections of facilities, among other uses, and its collection is essential to the overall regulatory scheme designed to ensure the safety of the Nation's blood supply.

Description of Respondents: Respondents to this collection of information are human blood and plasma donor centers, blood banks, certain transfusion services, other blood product manufacturers, independent laboratories that engage in quality control and testing for registered blood product establishments and manufacturers of devices licensed under section 351 of the Public Health Service Act.

We estimate the burden of the information collection as follows:

Based on our evaluation of Fiscal Year 2019 data from CBER's Blood Establishment Registration and Product Listing system, we have adjusted the currently approved burden estimate we attribute to establishment registration and product listing to reflect a slight increase in submissions; however, the overall burden has not changed.

Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

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

• Food from Unsafe Sources,

• Poor Personal Hygiene,

• Inadequate Cooking,

• Improper Holding/Time and Temperature, and

• Contaminated Equipment/Cross-Contamination.

FDA developed reports summarizing the findings for each of the three data collection periods, which were released in 2000, 2004, and 2009 (Refs. 1 to 3). Data from all three data collection periods were analyzed to detect trends in improvement or regression over time and to determine whether progress had been made toward the goal of reducing the occurrence of foodborne illness risk factors in selected retail and foodservice facility types (Ref. 4).

Using this 10-year survey as a foundation, in 2013 to 2014, FDA initiated a new study period. This study will span 10 years. FDA completed the baseline data collection in select healthcare, schools, and retail food store facility types in 2015 to 2016, and these data are being evaluated for trends and significance. A second data collection began in 2019 to 2020 and will be completed if it is safe to do so (pending COVID-19 pandemic), and an additional data collection is planned for 2023 to 2024 (the subject of this information collection request extension). Three data collections are necessary to trend the data.

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

• Develop retail food safety initiatives, policies, and targeted intervention strategies focused on controlling foodborne illness risk factors;

• provide technical assistance to State, local, tribal, and territorial regulatory professionals;

• identify FDA retail work plan priorities; and

• inform FDA resource allocation to enhance retail food safety nationwide.

The statutory basis for FDA conducting this study is derived from the Public Health Service Act (PHS Act) (42 U.S.C. 243, section 311(a)). Responsibility for carrying out the provisions of the PHS Act relative to food protection was transferred to the Commissioner of Food and Drugs in 1968 (21 CFR 5.10(a)(2) and (4)). Additionally, the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq. ) and the Economy Act (31 U.S.C. 1535) require FDA to provide assistance to other Federal, State, and local government bodies.

The objectives of this study are to:

• Identify the least and most often occurring foodborne illness risk factors and food safety behaviors/practices in select retail food establishments within the United States.

• determine the extent to which food safety management systems and the presence of a certified food protection manager impact the occurrence of foodborne illness risk factors and food safety behaviors/practices; and

• determine whether the occurrence of foodborne illness risk factors food safety behaviors/practices in delis differs based on an establishment's risk categorization and status as a single-unit or multiple-unit operation ( e.g., establishments that are part of an operation with two or more units).

The methodology to be used for this information collection is described as follows. To obtain a sufficient number of observations to conduct statistically significant analysis, FDA will conduct approximately 400 data collections in each facility type. This sample size has been calculated to provide for sufficient observations to be 95 percent confident that the compliance percentage is within 5 percent of the true compliance percentage.

A geographical information system database containing a listing of businesses throughout the United States provides the establishment inventory for the data collections. FDA samples establishments from the inventory based on the descriptions in table 1. FDA does not intend to sample operations that handle only prepackaged food items or conduct low-risk food preparation activities. The “FDA Food Code” contains a grouping of establishments by risk, based on the type of food preparation that is normally conducted within the operation (Ref. 5). The intent is to sample establishments that fall under risk categories 2 through 4.

FDA has approximately 25 Regional Retail Food Specialists (Specialists) who serve as the data collectors for the 10-year study. The Specialists are geographically dispersed throughout the United States and possess technical expertise in retail food safety and a solid understanding of the operations within each of the facility types to be surveyed. The Specialists are also standardized by FDA's Center for Food Safety and Applied Nutrition personnel in the application and interpretation of the FDA Food Code (Ref. 5).

Sampling zones have been established that are equal to the 175-mile radius around a Specialist's home location. The sample is selected randomly from among all eligible establishments located within these sampling zones. The Specialists are generally located in major metropolitan areas ( i.e., population centers) across the contiguous United States. Population centers usually contain a large concentration of the establishments FDA intends to sample. Sampling from the 175-mile radius sampling zones around the Specialists' home locations provides three advantages to the study:

1. It provides a cross-section of urban and rural areas from which to sample the eligible establishments.

2. It represents a mix of small, medium, and large regulatory entities having jurisdiction over the eligible establishments.

3. It reduces overnight travel and therefore reduces travel costs incurred by the Agency to collect data.

The sample for each data collection period is evenly distributed among Specialists. Given that participation in the study by industry is voluntary and the status of any given randomly selected establishment is subject to change, substitute establishments have been selected for each Specialist for cases where the institutional foodservice, school, or retail food store facility is misclassified, closed, or otherwise unavailable, unable, or unwilling to participate.

Prior to conducting the data collection, Specialists contact the State or local jurisdiction that has regulatory responsibility for conducting retail food inspections for the selected establishment. The Specialist verifies with the jurisdiction that the facility has been properly classified for the purposes of the study and is still in operation. The Specialist ascertains whether the selected facility is under legal notice from the State or local regulatory authority. If the selected facility is under legal notice, the Specialist will not conduct a data collection, and a substitute establishment will be used. An invitation is extended to the State or local regulatory authority to accompany the Specialist on the data collection visit.

A standard form is used by the Specialists during each data collection. The form is divided into three sections: Section 1—”Establishment Information”; Section 2—”Regulatory Authority Information”; and Section 3—”Foodborne Illness Risk Factor and Food Safety Management System Assessment.” The information in Section 1—”Establishment Information” of the form is obtained during an interview with the establishment owner or person in charge by the Specialist and includes a standard set of questions.

The information in Section 2—”Regulatory Authority Information” is obtained during an interview with the program director of the State or local jurisdiction that has regulatory responsibility for conducting inspections for the selected establishment. Section 3 includes three parts: Part A for tabulating the Specialists' observations of the food employees' behaviors and practices in limiting contamination, proliferation, and survival of food safety hazards; Part B for assessing the food safety management system being implemented by the facility; and Part C for assessing the frequency and extent of food employee hand washing. The information in Part A is collected from the Specialists' direct observations of food employee behaviors and practices. Infrequent, nonstandard questions may be asked by the Specialists if clarification is needed on the food safety procedure or practice being observed. The information in Part B is collected by making direct observations and asking followup questions of facility management to obtain information on the extent to which the food establishment has developed and implemented food safety management systems. The information in Part C is collected by making direct observations of food employee hand washing. No questions are asked in the completion of Section 3, Part C of the form.

FDA collects the following information associated with the establishment's identity: Establishment name, street address, city, state, ZIP code, county, industry segment, and facility type. The establishment identifying information is collected to ensure the data collections are not duplicative. Other information related to the nature of the operation, such as seating capacity and number of employees per shift, is also collected. Data will be consolidated and reported in a manner that does not reveal the identity of any establishment included in the study.

FDA has collaborated with the Food Protection and Defense Institute to develop a web-based platform in FoodSHIELD to collect, store, and analyze data for the Retail Risk Factor Study. This platform is accessible to State, local, territorial, and tribal regulatory jurisdictions to collect data relevant to their own risk factor studies. For the 2015 to 2016 data collection, FDA piloted the use of hand-held technology for capturing the data onsite during the data collection visits. The tablets that were made available for the data collections were part of a broader FDA initiative focused on internal uses of hand-held technology. The tablets provided for the data collection presented several technical and logistical challenges and increased the time burden associated with the data collection as compared to the manual entry of data collections. For these reasons FDA will not be incorporating use of hand-held technology in subsequent data collections during the 10-year study period.

When a data collector is assigned a specific establishment, he or she conducts the data collection and enters the information into the web-based data platform. The interface will support the manual entering of data, as well as the ability to directly enter information in the database via a web browser.

The burden for the 2023 to 2024 data collection is as follows. For each data collection, the respondents will include: (1) The person in charge of the selected facility (whether it be a healthcare facility, school, or supermarket/grocery store); and (2) the program director (or designated individual) of the respective regulatory authority. To provide the sufficient number of observations needed to conduct a statistically significant analysis of the data, FDA has determined that 400 data collections will be required in each of the three facility types. Therefore, the total number of responses will be 2,400 (400 data collections x 3 facility types x 2 respondents per data collection).

The burden associated with the completion of Sections 1 and 3 of the form is specific to the persons in charge of the selected facilities. The burden includes the time it will take the person in charge to accompany the data collector during the site visit and answer the data collector's questions. The burden related to the completion of Section 2 of the form is specific to the program directors (or designated individuals) of the respective regulatory authorities. This burden includes the time it will take to answer the data collectors' questions and is the same regardless of the facility type.

To calculate the estimate of the hours per response, FDA uses the average data collection duration for similar facility types during the FDA's 2008 Risk Factor Study (Ref. 3) plus an additional 30 minutes (0.5 hours) for the information related to Section 3, Part B of the form. FDA estimates that it will take the persons in charge of healthcare facility types, schools, and retail food stores 150 minutes (2.5 hours), 120 minutes (2 hours), and 180 minutes (3 hours), respectively, to accompany the data collectors while they complete Sections 1 and 3 of the form. FDA estimates that it will take the program director (or designated individual) of the respective regulatory authority 30 minutes (0.5 hours) to answer the questions related to Section 2 of the form. This burden estimate is unchanged from the last data collection. Hence, the total burden estimate for a data collection in healthcare facility types is 180 minutes (150 + 30) (3 hours), in schools is 150 minutes (120 + 30) (2.5 hours), and retail food stores is 210 minutes (180 + 30) (3.5 hours).

Based on the number of entry refusals from the 2015 to 2016 baseline data collection, we estimate a refusal rate of 2 percent for the data collections within healthcare, school, and retail food store facility types. The estimate of the time per non-respondent is 5 minutes (0.08 hours) for the person in charge to listen to the purpose of the visit and provide a verbal refusal of entry.

FDA estimates the burden of this collection of information as follows:

Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate.

The following references are on display in the Dockets Management Staff (see ADDRESSES ) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. FDA has verified the website addresses, as of the date this document publishes in the Federal Register , but websites are subject to change over time.

In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. App., this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality (the Council). The Council is authorized by Section 941 of the Public Health Service Act, 42 U.S.C. 299c. In accordance with its statutory mandate, the Council is to advise the Secretary of the Department of Health and Human Services and the Director of AHRQ on matters related to AHRQ's conduct of its mission including providing guidance on (A) priorities for health care research, (B) the field of health care research including training needs and information dissemination on health care quality and (C) the role of the Agency in light of private sector activity and opportunities for public private partnerships. The Council is composed of members of the public, appointed by the Secretary, and Federal ex-officio members specified in the authorizing legislation.

On Thursday, March 18, 2021, the Council meeting will convene at 10:00 a.m., with the call to order by the Council Chair and approval of previous Council summary notes. The meeting will begin with an update on AHRQ's recent accomplishments in Health Systems Research, Practice Improvement, Data and Analytics, and achieving organizational excellence. The agenda will also include a discussion of communication and value of health systems research, an update on PCOR Trust Funds, and a discussion of how AHRQ may advance health equity. The meeting will adjourn at 2:00 p.m. The meeting is open to the public. For information regarding how to access the meeting as well as other meeting details, including information on how to make a public comment, please go to https://www.ahrq.gov/news/events/nac/. The final agenda will be available on the AHRQ website no later than Thursday, March 11, 2021.

Intellectual Property

The following represents the intellectual property to be licensed under the prospective agreement:

(A) U.S. Provisional Patent Application 62/006, 313 entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-US-01], PCT Patent Application PCT/US2015/033473 entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-PCT-02], Australian Patent 2015270912 entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-AU-03], Canadian Patent Application 2951045 entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-CA-04], Chinese Patent Application 201580033802.5 entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-CN-05], European Patent 3149044 entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-EP-06] (validated in Germany [HHS Ref. E-042-2014-0-DE-19], Spain [HHS Ref. E-042-2014-0-ES-20], France [HHS Ref. E-042-2014-0-FR-21], the 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 lodged in Hong Kong [E-042-2014-0-HK-16]), Israeli Patent Application 249305 entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-IL-07], Indian Patent Application 291647041047 entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-IN-08], Japanese Patent Application 2016-571017 entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-JP-09], South Korean Patent Application 2016-7036828 entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-KR-10], Mexican Patent Application MX/a/2016/015834 entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-MX-11], New Zealand Patent Application 727167 entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-NZ-12], Saudi Arabian Patent Application 516380406 entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-SA-13], Singaporean Patent Application 11201609960Q entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-SG-14], United States Patent 10,287,350 entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-US-15], United States Patent Application 16/360,281 entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-US-17], New Zealand Patent Application 764530 entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-NZ-18], European Patent Application 20197459.9 entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-EP-25], Australian Patent Application 2020267211 entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-AU-26], and Japanese Patent Application XXX entitled “Chimeric Antigen Receptors Targeting CD-19” [HHS Ref. E-042-2014-0-JP-27], and all continuing U.S. and foreign patents/patent applications for the technology family.

The patent rights in these inventions have been assigned and/or exclusively licensed to the government of the United States of America.

The prospective exclusive license territory may be worldwide and the field of use may be limited to the following:

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

This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will be royalty bearing, and the prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the National Cancer Institute receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.

In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a completed license application, will not be treated confidentially, and may be made publicly available.

License applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information in these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552.

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

This information collection supports Agency regulations and associated guidance pertaining to expedited programs for serious conditions. The purpose of our regulations in 21 CFR part 312, subpart E is to establish procedures designed to expedite the development, evaluation, and marketing of new therapies intended to treat persons with life-threatening and severely debilitating illnesses, especially where no satisfactory alternative therapy exists. While the statutory standards of safety and effectiveness apply to all drugs, the many kinds of drugs that are subject to them, and the wide range of uses for those drugs, demand flexibility in applying the standards.

We have developed the guidance for industry entitled “Expedited Programs for Serious Conditions—Drugs and Biologics” as a single resource for information on FDA's policies and procedures related to the following expedited programs for serious conditions: (1) Fast track designation, (2) breakthrough therapy designation, (3) accelerated approval, and (4) priority review designation. The guidance describes threshold criteria generally applicable to expedited programs, including what is meant by serious condition, unmet medical need, and available therapy. The guidance addresses the applicability of expedited programs to rare diseases, clarification on available therapy, and additional detail on possible flexibility in manufacturing and product quality. It also clarifies the qualifying criteria for breakthrough therapy designation and provides examples of surrogate endpoints and intermediate clinical endpoints used to support accelerated approval.

A sponsor or applicant who seeks fast track designation is required to submit to us a request showing that the drug product: (1) Is intended for a serious or life-threatening condition and (2) has the potential to address an unmet medical need. We expect that most information to support a designation request will have been gathered under existing requirements for preparing an investigational new drug application (IND), new drug application (NDA), or biologics license application (BLA). If such information has already been submitted to us, the information may be summarized in the fast track designation request. A designation request should include, where applicable, additional information not specified elsewhere by statute or regulation. For example, additional information may be needed to show that a product has the potential to address an unmet medical need where an approved therapy exists for the serious or life-threatening condition to be treated. Such 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 designation request need not be voluminous, but it should be sufficient to permit a reviewer to assess whether the criteria for fast track designation have been met.

After we make a fast track designation, a sponsor or applicant may submit a premeeting package that may include additional information supporting a request to participate in certain fast track programs. The premeeting package serves as background information for the meeting and should support the intended objectives of the meeting. As with the request for fast track designation, we expect that most sponsors or applicants will have gathered such information to meet existing requirements for preparing an IND, an NDA, or a BLA. These may include descriptions of clinical safety and efficacy trials not conducted under an IND ( e.g., foreign studies) and information to support a request for accelerated approval. If such information has already been submitted to us, the information may be summarized in the premeeting package.

We also developed the guidance document entitled “Expedited Programs for Regenerative Medicine Therapies for Serious Conditions.” The guidance provides sponsors engaged in the development of regenerative medicine therapies for serious or life-threatening diseases or conditions with FDA's recommendations on the expedited development and review of these therapies. The guidance describes the expedited programs available to sponsors of regenerative medicine therapies for serious or life-threatening diseases or conditions, including those products designated as regenerative advanced therapies (which FDA refers to as “regenerative medicine advanced therapy” (RMAT) designation). The guidance also describes considerations in the clinical development of regenerative medicine therapies and opportunities for sponsors of regenerative medicine therapies to interact with the Center of Biologics Evaluation and Research review staff.

The guidance documents are available on our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents and were issued consistent with our good guidance practice regulations in 21 CFR 10.115, which provide for public comment at any time.

In the Federal Register of November 18, 2020 (85 FR 73487), we published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

We estimate the burden of this collection of information as follows:

Based on a review of the information collection since our last request for OMB approval, we have increased our burden estimates by 389 responses and 35,325 hours. As reflected in table 1, we estimate that 70 respondents will submit 101 requests for priority review designation annually. We assume an average of 30 hours is needed to prepare such a request.

We estimate that 119 respondents will submit 156 requests for breakthrough designation annually and assume that an average of 70 hours is needed to prepare such a request.

We estimate 205 respondents will submit 261 requests for fast track designation requests annually and assume that an average of 60 hours is needed to prepare such a request.

Of the requests for fast track designation made per year, we granted approximately 224 requests from 392 respondents, and for each of these granted requests, a premeeting package was submitted. We therefore assume an average burden of 100 hours per respondent for preparing a premeeting package.

Finally, we estimate 33 respondents will submit 38 requests for RMAT designation and assume that an average of 60 hours is needed to prepare such a request.