Title: Animal Welfare Act Workshop Registration.

OMB Number: 0518-033

Expiration Date: November 30, 2021.

Type of Request: To extend currently approved data collection form.

Abstract: This Web-based form collects information to register respondents in the workshop, Meeting the Information Requirements of the Animal Welfare Act. Information collected includes the following: preference of workshop date, name, title/position, years of professional experience, organization name, highest level of education, age, mailing address, phone number, and email address. Five questions are asked regarding database searching experience, membership on an Institutional Animal Care and Use Committee, position as principal investigator, and goals for attending the workshop.

Estimate of Burden: Public reporting burden for this collection of information is estimated to average 5 minutes per response.

Respondents: Principal investigators, members of Institutional Animal Care and Use Committees, animal care personnel, veterinarians, information providers, and administrators of animal use programs.

Estimated number of Respondents: 180 per year.

Estimated Total Annual Burden on Respondents: 15 hours.

Comments are invited on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (b) the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and the assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who respond, including the use of appropriate automated, electronic, mechanical, or other technology. Comments should be sent to the address in the preamble. All responses to this notice will be summarized and included in the request for Office of Management and Budget (OMB) approval. All comments will become a matter of public record.

Section 4314 (c) of Title 5, U.S.C., requires each agency to establish, in accordance with regulations, one or more Senior Executive Service (SES) performance review boards. The function of the boards is to review and evaluate the initial appraisal of senior executives' performance and make recommendations to the appointing authority relative to the performance of these executives. Because of its small size, the Access Board has appointed SES career members from other federal agencies to serve on its performance review board. The members of the performance review board for the Access Board are:

• Craig Luigart, Chief Information Officer, Veterans Health Administration, Department of Veterans Affairs;

• Rebecca Bond, Chief, Disability Rights Section, Department of Justice;

• Jennifer Sheehy, Acting Assistant Secretary, Office of Disability Employment Policy, Department of Labor.

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 Office within 30 days following the meeting. Written comments may be mailed to Ana Victoria Fortes at afortes@usccr.gov in the Regional Programs Unit Office/Advisory Committee Management Unit. Persons who desire additional information may contact the Regional Programs Unit Office (202) 681-0587.

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

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

Exceptional Circumstance: Pursuant to 41 CFR 102-3.150, the notice for this meeting is given less than 15 calendar days prior to the meeting because of the exceptional circumstances of the COVID crisis and DFO availability.

The meeting is 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. Individuals 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.

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 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.

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 Office within 30 days following the meeting. Written comments may be mailed to Ana Victoria Fortes at afortes@usccr.gov in the Regional Programs Unit Office/Advisory Committee Management Unit. Persons who desire additional information may contact the Regional Programs Unit Office (202) 681-0587.

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

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

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 emailed to Brooke Peery, DFO, at bpeery@usccr.gov.

Records and documents discussed during the meeting will be available for public viewing prior to and after the meetings at https://www.facadatabase.gov/FACA/FACAPublicViewCommitteeDetails?id=a10t0000001gzkZAAQ.

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

Members of the public may listen to the discussion. This meeting is available to the public through the public WebEx registration link listed above. An open comment period will be provided to allow members of the public to make a statement as time allows. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. 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 also entitled to 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 Brooke Peery at bpeery@usccr.gov. Persons who desire additional information may contact the Regional Programs Unit Office/Advisory Committee Management Unit at (202) 701-1376.

Records generated from this meeting may be inspected and reproduced at the Regional Programs Unit Office, as they become available, both before and after the meeting. Records of the meeting will be available at: https://www.facadatabase.gov/FACA/FACAPublicViewCommitteeDetails?id=a10t0000001gzkZAAQ .

Please click on the “Meeting Details” and “Documents” links. Persons interested in the work of this Committee are also directed to the Commission's website, http://www.usccr.gov, or may contact the Regional Programs Unit office at the above email address.

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 Office within 30 days following the meeting. Written comments may be mailed to Ana Victoria Fortes at afortes@usccr.gov in the Regional Programs Unit Office/Advisory Committee Management Unit. Persons who desire additional information may contact the Regional Programs Unit Office (202) 681-0587.

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

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

List of Petitions Received by EDA for Certification of Eligibility To Apply for Trade Adjustment Assistance [4/14/2021 through 4/21/2021] Firm name Firm address Date

Title III of the Export Trading Company Act of 1982 (15 U.S.C. 4001-21) (“the Act”) authorizes the Secretary of Commerce to issue Export Trade Certificates of Review. A Certificate protects the holder and the members identified in the Certificate from State and Federal government antitrust actions and from private treble damage antitrust actions for the export conduct specified in the Certificate and carried out in compliance with its terms and conditions. The regulations implementing Title III are found at 15 CFR part 325. OTEA is issuing this notice pursuant to 15 CFR 325.6(a), which requires the Secretary of Commerce to publish a summary of the application in the Federal Register , identifying the applicant and each member and summarizing the proposed export conduct.

Interested parties may submit written comments relevant to the determination whether an amended Certificate should be issued. If the comments include any privileged or confidential business information, it must be clearly marked and a nonconfidential version of the comments (identified as such) should be included. Any comments not marked as privileged or confidential business information will be deemed to be nonconfidential.

Written comments should be sent to ETCA@trade.gov . An original and five (5) copies, plus two (2) copies of the nonconfidential version, should also be submitted no later than 20 days after the date of this notice to: Office of Trade and Economic Analysis, International Trade Administration, U.S. Department of Commerce, Room 21028, Washington, DC 20230.

Information submitted by any person is exempt from disclosure under the Freedom of Information Act (5 U.S.C. 552). However, nonconfidential versions of the comments will be made available to the applicant if necessary, for determining whether or not to issue the Certificate. Comments should refer to this application as “Export Trade Certificate of Review, application number 94-7A007.”

A summary of the application follows.

Applicant: Florida Citrus Exports, L.C., 7355 SW 9th Street, Vero Beach, Florida, 32968.

Contact: William M. Stainton, Esq., Attorney; Email: wms@macfar.com .

Application No.: 94-7A007.

Date Deemed Submitted: April 14, 2021.

FCE seeks to amend its Certificate as follows:

1. Add the following entity as a new Member of the Certificate within the meaning of section 325.2(1) of the Regulations (15 CFR 325.2(1)):

2. Remove the following entities as Members of the Certificate:

FCE's proposed amendment would result in the following list of Members under the Certificate:

Background

Commerce is conducting an administrative review of the antidumping duty order on solar products from Taiwan, 1 in accordance with section 751(a)(1)(B) of Tariff Act of 1930, as amended (the Act). On April 8, 2020, in accordance with 19 CFR 351.221(c)(1)(i), we initiated this administrative review of the Order covering thirty-four producers and/or exporters of the subject merchandise. 2 On June 3, 2020, Commerce selected ISEC and URE as the mandatory respondents. 3

On April 24, 2020, Commerce tolled all deadlines in administrative reviews by 50 days. 4 Subsequently, on July 21, 2020, Commerce tolled certain deadlines in administrative reviews by an additional 60 days. 5 On February 8, 2021, we postponed the preliminary results of this review by 64 days until April 23, 2021. 6 For a detailed description of the events that followed the initiation of this review, see the Preliminary Decision Memorandum. 7

The merchandise covered by the Order is solar products. For a complete description of the scope of the Order, see the Preliminary Decision Memorandum. 8

Commerce is conducting this review in accordance with section 751(a) of the Act. Export prices are calculated in accordance with section 772 of the Act and 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. A list of topics discussed in the Preliminary Decision Memorandum is attached as an appendix to this notice.

The Preliminary Decision Memorandum is a public document and is 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 Preliminary Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/.

Pursuant to 19 CFR 351.213(d)(3), it is Commerce's practice to rescind an administrative review with respect to a particular exporter or producer when Commerce concludes that it had no shipments ( e.g., no reviewable entries of subject merchandise) during the POR subject to the antidumping duty order. At the end of an administrative review, the suspended entries are liquidated at the assessment rate computed for the review period. 9 Therefore, for an administrative review to be conducted, there must be a reviewable, suspended entry to be liquidated at the newly calculated assessment rate.

On March 5, 2021, ISEC reported that IEC ceased business operations, and was dissolved and liquidated prior to the POR. 10 As such, Commerce has preliminarily concluded that IEC had no shipments during the POR. Thus, Commerce preliminary intends to rescind this administrative review with respect to IEC pursuant to 19 CFR 351.213(d)(3). Consistent with Commerce's practice, 11 Commerce intends to complete the review and issue appropriate instructions to U.S. Customs and Border Protection (CBP) based on the final results of this review.

Section 351.213(d)(1) of Commerce's regulations provides that Commerce will rescind an administrative review, in whole or in part, if the party that requested the review withdraws its request for review within 90 days of the date of publication of the notice of initiation of the requested review. Commerce published the Initiation Notice on April 8, 2020. 12 On April 29, 2020, SunPower Manufacturing Oregon, LLC (the petitioner) withdrew its request for review of Sino-American Silicon Products Inc. (SAS) and Solartech Energy Corporation (Solartech). 13 On May 20, 2020, Mega Sunergy Co., Ltd. (Mega) withdrew its request for review for itself. 14 Because the review requests for SAS and Mega were timely withdrawn, and because no other party requested a review of SAS and Mega, we are rescinding the reviews with respect to SAS and Mega.

Additionally, Commerce previously determined in a changed circumstances review that URE is the successor-in-interest to Solartech, as well as Gintech Energy Corporation (Gintech), and Neo Solar Power Corporation (Neo Solar). 15 Therefore, because Solartech, Gintech, and Neo Solar are no longer in existence, Commerce is partially rescinding this administrative review with respect to Solartech, Gintech, and Neo Solar, in accordance with 19 CFR 351.213(d)(3). The review will continue with respect to all other entities listed in the Initiation Notice.

Background

On November 3, 2020, Commerce published a notice of opportunity to request an administrative review of the AD duty order on coated paper from Indonesia for the POR. 1 On November 30, 2020, Verso Corporation (Verso) timely requested an administrative review of the AD order with respect to three companies: PT. Pindo Deli Pulp and Paper Mills, PT. Pabrik Kertas Tjiwi Kimia Tbk, and PT Indah Kiat Pulp & Paper Tbk. 2 On January 6, 2021, in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.221(c)(1)(i), Commerce initiated an administrative review of the AD order for the POR with respect to these three companies. 3 On March 26, 2021, Verso timely withdrew its request for review for all three companies. 4

Pursuant to 19 CFR 351.213(d)(1), Commerce will rescind an administrative review, in whole or in part, if the parties that requested the review withdraw their requests within 90 days of the publication date of the notice of initiation of the requested review. Verso withdrew its request for review for all three companies within 90 days of the publication of the Initiation Notice, and no other party requested an administrative review of the AD order for the POR. Therefore, in accordance with 19 CFR 351.213(d)(1), Commerce is rescinding the administrative review of the AD order on coated paper from Indonesia for the POR in its entirety.

Commerce will instruct U.S. Customs and Border Protection (CBP) to assess antidumping duties on all appropriate entries of coated paper from Indonesia during the POR at rates equal to the cash deposit rates for estimated antidumping duties that were required at the time of entry, or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(1)(i). Commerce intends to issue appropriate assessment instructions to CBP no earlier than 35 days after the date of publication of this rescission notice in the Federal Register .

This notice serves as a final 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 review period. 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.

This notice also serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or 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 notice is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.213(d)(4).

Authority: 42 U.S.C. 7704(a)(5) and the Federal Advisory Committee Act, as amended, 5 U.S.C. App. The Committee is composed of 13 members, appointed by the Director of NIST, who were selected for their established records of distinguished service in their professional community, their knowledge of issues affecting NEHRP, and to reflect the wide diversity of technical disciplines, competencies, and communities involved in earthquake hazards reduction. In addition, the Chairperson of the U.S. Geological Survey Scientific Earthquake Studies Advisory Committee serves as an ex-officio member of the Committee.

Pursuant to the Federal Advisory Committee Act, as amended, 5 U.S.C. App., notice is hereby given that the ACEHR will meet on Monday, May 24, 2021, from 1:00 p.m. to 4:00 p.m. Eastern Time. The meeting will be open to the public, and will be held via web conference. Interested members of the public will be able to participate in the meeting from remote locations. The primary purpose of this meeting is for the Committee to develop their draft 2021 biennial report on the effectiveness of NEHRP. The agenda may change to accommodate Committee business. The final agenda and any meeting materials will be posted on the NEHRP website at http://nehrp.gov/ .

Individuals and representatives of organizations who would like to offer comments and suggestions related to the Committee's business are invited to request a place on the agenda. Approximately ten minutes will be reserved for public comments and speaking times will be assigned on a first-come, first-serve basis. The amount of time per speaker will be determined by the number of requests received. Questions from the public will not be considered during this period. All those wishing to speak must submit their request by email to Tina Faecke at tina.faecke@nist.gov by 5:00 p.m. Eastern Time, Monday, May 17, 2021. Speakers who wish to expand upon their oral statements, those who wish to speak but cannot be accommodated on the agenda, and those who are unable to attend remotely are invited to electronically submit written statements by email to tina.faecke@nist.gov .

Anyone wishing to attend this meeting via web conference must register by 5:00 p.m. Eastern Time, Monday, May 17, 2021. Please submit your full name, email address, and phone number to Tina Faecke at tina.faecke@nist.gov .

Authority: 42 U.S.C. 7704(a)(5) and the Federal Advisory Committee Act, as amended, 5 U.S.C. App. The Committee is composed of 13 members, appointed by the Director of NIST, who were selected for their established records of distinguished service in their professional community, their knowledge of issues affecting NEHRP, and to reflect the wide diversity of technical disciplines, competencies, and communities involved in earthquake hazards reduction. In addition, the Chairperson of the U.S. Geological Survey Scientific Earthquake Studies Advisory Committee serves as an ex-officio member of the Committee.

Pursuant to the Federal Advisory Committee Act, as amended, 5 U.S.C. App., notice is hereby given that the ACEHR will meet on Tuesday, August 10, 2021, from 1:00 p.m. to 4:00 p.m. Eastern Time. The meeting will be open to the public, and will be held via web conference. Interested members of the public will be able to participate in the meeting from remote locations. The primary purpose of this meeting is for the Committee to finalize their 2021 biennial report on the effectiveness of NEHRP. The agenda may change to accommodate Committee business. The final agenda and any meeting materials will be posted on the NEHRP website at http://nehrp.gov/ .

Individuals and representatives of organizations who would like to offer comments and suggestions related to the Committee's business are invited to request a place on the agenda. Approximately ten minutes will be reserved for public comments and speaking times will be assigned on a first-come, first-serve basis. The amount of time per speaker will be determined by the number of requests received. Questions from the public will not be considered during this period. All those wishing to speak must submit their request by email to Tina Faecke at tina.faecke@nist.gov by 5:00 p.m. Eastern Time, Tuesday, August 3, 2021. Speakers who wish to expand upon their oral statements, those who wish to speak but cannot be accommodated on the agenda, and those who are unable to attend remotely are invited to electronically submit written statements by email to tina.faecke@nist.gov .

Anyone wishing to attend this meeting via web conference must register by 5:00 p.m. Eastern Time, Tuesday, August 3, 2021. Please submit your full name, email address, and phone number to Tina Faecke at tina.faecke@nist.gov .

The purpose of the meeting is for the HMSMT to discuss and prepare reports for HMS items on the Council's June 2021 meeting agenda. There are two items on the Council meeting agenda that will be the focus of the HMSMT meeting, summarized below. The HMSMT also may discuss other items on the June Council agenda and conduct general workload planning.

First, the HMSMT needs to prepare an analysis of drift gillnet (DGN) fishery performance metrics. These performance metrics track bycatch of specified protected species and finfish species of concern and are reported to the Council each June based on available bycatch data. In June 2019, the Council endorsed a new analytical method proposed by the HMSMT. Because performance metrics were not reported in 2020, this would be the first year this new analytical method will be used.

Second, the HMSMT will discuss recommendations to address scoping and the development of a range of alternatives for DGN fishery hard caps. The Council took final action in September 2015 to implement “hard cap” for selected protected species taken in the DGN fishery as a bycatch mitigation measure. Implementing regulations became effective in February 2020 but were subsequently vacated by court order. The Council wishes to consider alternative bycatch mitigation methods, consistent with its original intent, and considering the reasons the previous implementing regulations were vacated by the Court.

A meeting agenda will be available on the Council website at least one week before the meeting.

Although non-emergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document 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.

Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt ( kris.kleinschmidt@noaa.gov; (503) 820-2412) at least 10 days prior to the meeting date.

Agenda Monday, May 17, 2021 through Thursday, May 20, 2021

The Crab Plan Team will review the final 2021 stock assessments for Aleutian Islands golden king crab and Pribilof Islands blue king crab. Additionally, the Crab Plan Team will discuss model scenarios for the September 2021 stock assessments for snow crab, Tanner crab, Bristol Bay red king crab, summer survey planning, VAST model, length-weight analyses, catch standardization, the Bering Sea fisheries research fund survey and snow crab workshop, Norton Sound red king crab growth, research priorities, the GMACS modeling framework, a crab stock assessment risk table, the EFH 5 year review, terms of reference for crab SAFE chapters, and plans for the Crab Plan Team's September 2021 meeting. The agenda is subject to change, and the latest version will be posted at https://meetings.npfmc.org/Meeting/Details/2045 prior to the meeting, along with meeting materials.

You can attend the meeting online using a computer, tablet, or smart phone; or by phone only. Connection information will be posted online at: https://meetings.npfmc.org/Meeting/Details/2045.

Public comment letters will be accepted and should be submitted electronically to https://meetings.npfmc.org/Meeting/Details/2045.

Agenda Monday, May 17, 2021, Through Tuesday, May 18, 2021

The May 2021 FMAC agenda will include (a) review of the 2020 observer annual report; (b) make recommendations for the 2022 Annual Deployment Plan; (c) discuss other analytical results and monitor committee meeting structure, and (d) other business.

The agenda is subject to change, and the latest version will be posted at https://meetings.npfmc.org/Meeting/Details/2064 prior to the meeting, along with meeting materials.

You can attend the meeting online using a computer, tablet, or smartphone; or by phone only. Connection information will be posted online at: https://meetings.npfmc.org/Meeting/Details/2064.

Public comment letters will be accepted and should be submitted electronically to https://meetings.npfmc.org/Meeting/Details/2064.

Title; Associated Form; and OMB Number: Aircraft and Personnel Automated Clearance System (APACS); OMB Control Number 0701-0160.

Needs and Uses: The information collection requirement is necessary to obtain PII information which is used by in-country U.S. Embassy approvers to grant country travel clearances, Geographical Combatant Commands approvers to grant theater travel clearances and by the Office of Secretary of Defense for Policy approvers to grant special area travel clearances. Aircrew PII information is used for verification, identification and authentication of travelers for aircraft and personnel travel clearances, as required by DoDD 4500.54E, DoD Foreign Clearance Program.

Affected Public: Individuals or households.

Annual Burden Hours: 246,000.

Number of Respondents: 492,000.

Responses per Respondent: 1.

Annual Responses: 492,000.

Average Burden per Response: 30 minutes.

Frequency: On occasion.

Title; Associated Form; and OMB Number: Global Combat Support System—Army Self Registration, OMB Control Number 0702-XXXX.

Needs and Uses: The information collection requirement is necessary to allow Active Duty Military, Government Civilians, Defense Contractors, Foreign and local National Defense Employees to access GCSS-Army to execute tactical logistics transaction throughout the Department of the Army.

Affected Public: Individuals and households.

Annual Burden Hours: 635.5.

Number of Respondents: 3813.

Responses per Respondent: 1.

Annual Responses: 3813.

Average Burden per Response: 10 minutes.

Frequency: On occasion.

Users of the Enterprise Information Systems, Global Combat Support System-Army (GCSS-Army) are Active Duty Military, Government Civilians, Defense Contractors, Foreign and Local National Defense Employees who need to utilize it to perform logistics operations. These users utilize the Graphic User Interface (GUI) to input their personal data. The system then generates a user record in the system for each user, which allows the users to log into the system to perform their daily duties. There are no paper forms associated with this activity. It is essential to the Army's logistics mission for Active Duty Military, Government Civilians, Defense Contractors, Foreign and Local National Defense employees logging into the system to execute logistics transactions.

Title; Associated Form; and OMB Number: Appointment of Chaplains for the Military Services; DD Form 2088; OMB Control Number 0704-0190.

NEEDS AND USES: This information collection is needed to ensure that religious faith groups are appropriately organized and authorized by their constituencies to endorse clergy for service as chaplains in the Military Services. It also certifies the number of years of professional experience for each candidate.

DD Form 2088, “Statement of Ecclesiastical Endorsement,” is used to endorse that a Religious Ministry Professional is professionally qualified to become a chaplain. It requests information about name, address, professional experience, and previous military experience to be used in determining grade, date of rank, and eligibility for promotion for appointees to the chaplaincies of the armed forces.

Affected Public: Individuals or households.

Annual Burden Hours: 1,125 hours.

Number of Respondents: 150.

Responses per Respondent: 10.

Annual Responses: 1500.

Average Burden per Response: 45 minutes.

Frequency: On occasion.

Title; Associated Form; and OMB Number: Defense Biometric Identification System (DBIDS) Registration Application; OMB Control Number 0704-0455.

Needs and Uses: The information collection requirement is necessary to obtain and record the biographic & biometric data connected with positively identifying identity, eligibility for access, and fitness within DBIDS and shared with IMESA/IOLS. The form data is used in the determination of access at DBIDS sites and affiliated systems through use of IMESA/IolS.

Affected Public: Individuals or households.

Annual Burden Hours: 291,667 hours.

Number of Respondents: 2,500,000.

Responses per Respondent: 1.

Annual Responses: 2,500,000.

Average Burden per Response: 7 minutes.

Frequency: On occasion.

Title; Associated Form; and OMB Number: Puerto Rico Beach Recreation Value and Benefits Surveys; OMB Control Number 0710-XXXX.

Needs and Uses: The purpose of this study is to employ necessary methods of welfare economics for analyzing the net economic value of beach re-nourishment. U.S. Army Corps of Engineers (USACE) Principle and Guidelines stipulates that when beach visitation exceeds the 750,000 annual visitation threshold, contingent valuation (CV) or travel cost method (TCM) are the required metrics for measuring benefits accruing from recreation. This study will produce empirical estimates of economic value of beach replenishment, focusing on recreation value, how recreation value varies with programmatic attributes, and economic impacts stemming from changes in recreation and recreation value. This study will employ utility-theoretic micro-econometric models, with revealed and stated preference data, and will focus on San Juan, Puerto Rico. This project is being undertaken under the authority for the Puerto Rico Coastal Study and the San Juan Metro Area, Puerto Rico Study is Section 204 of the River and Harbor Act of 1970, Public Law 91-611, which authorizes the Secretary of the Army, acting though the Chief of Engineers, to prepare plans for the development, utilization and conservation of water and related land resources of drainage basins and coastal areas in the Commonwealth of Puerto Rico. The initial project scope also included data collection in Dade County FL, Pinellas County FL, Collier County FL, and Folly Beach SC. The COVID-19 pandemic prohibited the USACE from collecting the necessary information onsite. An alternative data source was found for those counties, but these data do not provide information on Puerto Rico beaches. Thus, the project scope has been modified to assess beach visitation and erosion management preferences for both Puerto Rico residents and U.S. visitors to Puerto Rico.

Affected Public: Individuals and Households.

Annual Burden Hours: 512.5

Number of Respondents: 2050

Responses per Respondent: 1

Annual Responses: 2050

Average Burden per Response: 15 minutes

Frequency: On occasion.

Eligible respondents for this survey are individuals 18 years of age or older that reside in Puerto Rico or have taken a trip to the Caribbean since 2016. Puerto Rico residents comprise the target population for the domestic survey. The majority of international tourist visits to Puerto Rico (in excess of 90%) originate in the United States, so our tourism sample focuses on US households that have taken a trip to the Caribbean since 2016. We are utilizing on online panel of respondents that is managed using scientific sampling properties to provide a rotating panel of respondents that closely resemble the population of interest. If approved, the survey will be administered online to a total of 2,050 beach recreationists, consisting of 1,050 responses from citizens of Puerto Rico and 1,000 from US tourists that travel to Puerto Rico via air or cruise.

The results of the USMC COVID-19 Vaccine Survey will provide leadership with an understanding of Marines' propensity to take the COVID-19 vaccine and other related factors. COVID-19 vaccine distribution has begun in the Marine Corps as per the DoD vaccination schedule. Because the vaccine has been authorized under a EUA vice full approval, the vaccine is being offered voluntarily. This survey is being conducted in order to better understand why active duty and reserve Marines choose to get the vaccine or not as well as identify any generalized misunderstandings or misinformation Marines may have about the vaccines. The data will enable the Marine Corps' Communication Directorate, COVID-19 Cell, and Health Services to address inaccurate information so Marines can make an informed choices about the vaccine. This exemption will allow the survey to be fielded as soon as possible so the results can inform strategic messaging efforts by late spring 2021.

Title; Associated Form; and OMB Number: COVID-19 Vaccine Survey; 0703-CNVS.

Type of Request: New.

Number of Respondents: 9,000.

Responses per Respondent: 1.

Annual Responses: 9,000.

Average Burden per Response: 5 minutes.

Annual Burden Hours: 750.

Affected Public: Individuals and households.

Frequency: Once.

Respondent's Obligation: Voluntary.

Comments are invited on: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of DOD, including whether the information collected has practical utility; (2) the accuracy of DOD's estimate of the burden (including hours and cost) of the proposed collection of information; (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 automated collection techniques or the use of other forms of information technology.

We provide this notice in accordance with Privacy Act of 1974, as amended (Privacy Act) (5 U.S.C. 552a); Office of Management and Budget (OMB) Final Guidance Interpreting the Provisions of Public Law 100-503, the Computer Matching and Privacy Protection Act of 1988, 54 FR 25818 (June 19, 1989); and OMB Circular No. A-108.

Participating Agencies: The U.S. Department of Education and the U.S. Department of Veterans Affairs.

Authority for Conducting the Matching Program: ED's legal authority to enter into the matching program and to disclose information thereunder is sections 420N(c), 437(a)(1), 455(a)(1), and 464(c)(1)(F)(ii & iii) of the HEA (20 U.S.C. 1070g-2(c), 1087(a)(1), 1087e(a)(1), and 1087dd(c)(1)(F)(ii & iii)); the regulations promulgated pursuant to those HEA sections (34 CFR 674.61(b), 682.402(c), 685.213, and 686.42(b)); and subsections (a)(8) and (b)(1) of the Privacy Act (5 U.S.C. 552a(a)(8) and (b)(1)). VA's legal authority to enter into this matching program and to disclose information thereunder is subsections (a)(8) and (b)(3) of the Privacy Act (5 U.S.C 552a(a)(8) and (b)(3)).

Purpose(s): This matching program will assist ED in its obligation to ensure that borrowers of title IV loans or TEACH Grant service obligations more efficiently and effectively apply for TPD discharge of their title IV loans or TEACH Grant service obligations. ED will proactively send notices to borrowers who VA has designated as (1) having a service-connected disability rating that is 100 percent disabling, or (2) being totally disabled based on an individual unemployability rating, informing them that ED will discharge the borrower's title IV loans or TEACH Grant service obligations no earlier than 61 days from the date that ED sends the notification to the borrower, unless the borrower chooses to have their title IV loans or TEACH Grant service obligations discharged earlier or chooses to opt out of the TPD discharge within 60 days from the date that ED sends the notification to the borrower. ED's notices also will inform these borrowers that ED has accepted information obtained from the VA in lieu of the borrower's submission of a VA Statement with the borrower's TPD loan discharge application, thereby simplifying the TPD discharge process for borrowers.

Categories of Individuals: The individuals whose records are used in the matching program are described as follows:

VA will disclose to ED records on Veterans who are in receipt of VA disability compensation benefits with a VA determination that they have a 100 percent disabling service-connected disability rating or that they are totally disabled based on an individual unemployability rating, along with the VA disability determination date for each such individual. ED will then match the file received from VA with ED's records on borrowers of title IV loans, as contained in ED's system of records entitled “National Student Loan Data System (NSLDS)” (18-11-06) who owe a balance on a title IV Loan, have had any loans under title IV of the HEA written off due to default, or are responsible for completing a service obligation in exchange for having received a TEACH Grant under the TEACH Grant Program.

Categories of Records: The records used in the matching program are described as follows:

VA will disclose to ED, on a quarterly basis, the name (first, middle, and last), date of birth (DOB), and Social Security number (SSN) of all individuals who are in receipt of VA disability compensation benefits with a VA determination that they have a 100 percent disabling service-connected disability rating or that they are totally disabled based on an individual unemployability rating, along with the VA disability determination date for each such individual. ED will match the VA records to the ED system of records entitled “National Student Loan Data System (NSLDS)” (18-11-06).

System(s) of Records: VA will use the VA system of records entitled “Compensation, Pension, Education, and Vocational Rehabilitation and Employment Records—VA” (58VA21/22/28), last published in the Federal Register in full on February 14, 2019 (84 FR 4138). VA has determined that routine use 39 in the foregoing system of records is compatible with the purpose for which the information is collected and contains appropriate Privacy Act disclosure authority.

ED will match information obtained from VA with ED records maintained in ED's system of records entitled “National Student Loan Data System (NSLDS)” (18-11-06). The NSLDS system of records notice was last published in the Federal Register in full on September 9, 2019 (84 FR 47265).

ED will also maintain matched information obtained from VA in the system of records identified as “Common Services for Borrowers (CSB) (18-11-16),” as last published in the Federal Register in full on September 2, 2016 (81 FR 60683).

Accessible Format: On request to Lisa Tessitore, Program Operations Specialist, Federal Student Aid, U.S. Department of Education, 830 First Street NE, Washington, DC 20202-5320, telephone: (202) 377-3249. Individuals with disabilities can obtain this document in an accessible format. The Department will provide the requestor with an accessible format that may include Rich Text Format (RTF) or text format (txt), a thumb drive, an MP3 file, braille, large print, audiotape, or compact disc, or other accessible format.

Electronic Access to This Document: The official version of this document is the document published in the Federal Register . You may access the official edition of the Federal Register and the Code of Federal Regulations at www.govinfo.gov. At this site you can view this document, as well as all other documents of this Department published in the Federal Register , in text or Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

You may also access documents of the Department published in the Federal Register by using the article search feature at www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

Full Text of Announcement I. Funding Opportunity Description

Purpose of Program: The GEAR UP program is a discretionary grant program that encourages eligible entities to provide support, and maintain a commitment to, eligible low-income students, including students with disabilities, to assist the students in obtaining a secondary school diploma (or its recognized equivalent) and to prepare for and succeed in postsecondary education. Under the GEAR UP program, the Department awards grants to two types of entities: (1) States and (2) eligible partnerships.

Background: In this notice, the Department invites applications for State grants only. We will invite applications for Partnership grants in another notice published in the Federal Register . Required services under the GEAR UP program are specified in section 404D(a) of the Higher Education Act of 1965, as amended (HEA) (20 U.S.C. 1070a-24(a)), and permissible services under the GEAR UP program are specified in section 404D(b) and (c) of the HEA (20 U.S.C. 1070a-24(b) and (c)). Grantee activities must include providing financial aid information for postsecondary education; encouraging enrollment in rigorous and challenging coursework in order to reduce the need for remediation at the postsecondary level; implementing activities to improve the number of participating students who obtain a secondary school diploma and who complete applications for and enroll in a program of postsecondary education; and providing scholarships as specified in section 404E of the HEA. Additional permissible activities for State grantees are specified in sections 404D(b) and (c) of the HEA.

Recent data suggest that the COVID-19 pandemic has created academic challenges and greatly exacerbated mental health issues among school-aged youth. For example, the Centers for Disease Control (CDC) reports the proportion of emergency room visits related to mental health crises has increased dramatically for young children and adolescents since the start of the pandemic. 1 Researchers also estimate that COVID-19-related disruptions may put students substantially behind, particularly in topics like mathematics, causing many to reenter school with more variability in their academic skills compared to normal circumstances. 2

In addition, the transition to remote learning has introduced academic challenges for all students, particularly students from low-income backgrounds, students of color, English learners, and students with disabilities. Students living in rural communities face additional challenges to accessing instruction. Across the Nation, there are gaps in access to broadband in rural locations and on Tribal lands. In addition to less access to academic instruction, COVID-19 has impacted the well-being of rural students  3 and their likelihood of enrolling in postsecondary education. 4

Priorities: This notice contains two competitive preference priorities and three invitational priorities. In accordance with 34 CFR 75.105(b)(2)(ii) and (iv), Competitive Preference Priority 1 is from section 404A(b)(3) of the HEA (20 U.S.C. 1070a-21(b)(3)) and the GEAR UP program regulations (34 CFR 694.19). Competitive Preference Priority 2 is from 34 CFR 75.226(d).

Competitive Preference Priorities: For FY 2021 and any subsequent year in which we make awards from the list of unfunded applications from this competition, these priorities are competitive preference priorities. Under 34 CFR 75.105(c)(2)(i), we award up to an additional five points to an application, depending on how well the application meets the priorities.

These priorities are:

Competitive Preference Priority 1—Successful State GEAR UP grant prior to August 14, 2008 (Up to 2 points).

We give priority to an eligible applicant for a State GEAR UP grant that has: (a) Carried out a successful State GEAR UP grant prior to August 14, 2008, determined on the basis of data (including outcome data) submitted by the applicant as part of its annual and final performance reports and the applicant's history of compliance with applicable statutory and regulatory requirements; and (b) a prior demonstrated commitment to early intervention leading to college access through collaboration and replication of successful strategies.

Competitive Preference Priority 2—Moderate Evidence (Up to 3 points).

Applications supported by evidence that meets the conditions in the definition of “moderate evidence” (as defined in this notice).

Applicants can cite What Works Clearinghouse (WWC) intervention reports, WWC practice guides, or individual studies—both those already listed in the Department's WWC Database of Individual Studies  5 and those that have not yet been reviewed by the WWC. Studies listed in the WWC Database of Individual Studies do not necessarily satisfy the criteria needed to meet the moderate evidence standard. Therefore, applicants should themselves ascertain the suitability of the study for the evidence priority.

The proposed studies must be cited in the section of the application that addresses Competitive Preference Priority 2 as well as on the Evidence Form. Applicants should also describe (1) the project component(s) from the cited research they intend to implement in their GEAR UP project, (2) the relevant outcome(s) that are included in both the study (or WWC practice guide or intervention report) and in the proposed project, (3) the research findings suggesting a favorable relationship between the project component and the relevant outcome, and (4) how the population and/or settings in the cited research overlap with that of the proposed project. The Department will review the research cited by the applicant to determine if it meets the requirements for moderate evidence, as well as whether it is sufficiently aligned with the project proposed.

Invitational Priorities: For FY 2021, and any subsequent year in which we make awards from the list of unfunded applications from this competition, these priorities are invitational priorities. Under 34 CFR 75.105(c)(1) we do not give an application that meets these invitational priorities a competitive or absolute preference over other applications.

These priorities are:

Invitational Priority 1—Building Capacity for Remote Learning.

Projects that are designed to address one or both of the following priority areas:

(a) Providing personalized and job-embedded professional learning to build the capacity of GEAR UP educators who serve GEAR UP participants to create remote learning experiences for GEAR UP participants that advance student engagement and learning through effective use of technology ( e.g., both live and video conferencing professional learning opportunities, professional learning networks or communities, and coaching).

(b) Providing access to software applications to GEAR UP participants without access to such software applications to meet all GEAR UP students' and GEAR UP educators' remote learning needs, regardless of whether students and educators are inside the school building or in remote learning environments.

For the purposes of this priority, “remote learning” means programming where at least part of the learning occurs away from the physical building in a manner that addresses a learner's education needs. Remote learning may include online, hybrid/blended learning, or non-technology-based learning ( e.g., lab kits, project supplies, paper packets).

Invitational Priority 2— Addressing the Impact of COVID-19 on Students' Mental Health and Academic Outcomes.

Projects designed to provide integrated student support services (also known as wrap-around services) for GEAR UP participants to address mental health and academic support needs due to the COVID-19 pandemic. An applicant should describe in its application how it will collaborate with any partners to provide resources to support students and communities hit the hardest by COVID-19 and implement evidence-based best practices to address the existing inequities exacerbated by the pandemic. The proposed system of integrated student support services should include services that meet the whole needs of students from low-income backgrounds, including aid for school supplies, transportation costs as allowable by program regulations, connections to mental health services, mentoring, tutoring, and peer support groups, that help ensure graduation from high school and enrollment in postsecondary education.

Invitational Priority 3—Providing GEAR UP Services to Schools Located in Rural Areas.

Applications that include descriptive plans to provide GEAR UP services and resources in rural communities and schools, including those local educational agencies (LEAs) with a locale code of 32, 33, 41, 42, or 43.

Definitions: These definitions are from 34 CFR 77.1(c).

Demonstrates a rationale means a key project component included in the project's logic model is informed by research or evaluation findings that suggest the project component is likely to improve relevant outcomes.

Experimental study means a study that is designed to compare outcomes between two groups of individuals (such as students) that are otherwise equivalent except for their assignment to either a treatment group receiving a project component or a control group that does not. Randomized controlled trials, regression discontinuity design studies, and single-case design studies are the specific types of experimental studies that, depending on their design and implementation ( e.g., sample attrition in randomized controlled trials and regression discontinuity design studies), can meet What Works Clearinghouse (WWC) standards without reservations as described in the WWC Handbooks:

(i) A randomized controlled trial employs random assignment of, for example, students, teachers, classrooms, or schools to receive the project component being evaluated (the treatment group) or not to receive the project component (the control group).

(ii) A regression discontinuity design study assigns the project component being evaluated using a measured variable ( e.g., assigning students reading below a cutoff score to tutoring or developmental education classes) and controls for that variable in the analysis of outcomes.

(iii) A single-case design study uses observations of a single case ( e.g., a student eligible for a behavioral intervention) over time in the absence and presence of a controlled treatment manipulation to determine whether the outcome is systematically related to the treatment.

Moderate evidence means that there is evidence of effectiveness of a key project component in improving a relevant outcome for a sample that overlaps with the populations or settings proposed to receive that component, based on a relevant finding from one of the following:

(i) A practice guide prepared by the WWC using version 2.1, 3.0, 4.0, or 4.1 of the WWC Handbooks reporting a “strong evidence base” or “moderate evidence base” for the corresponding practice guide recommendation;

(ii) An intervention report prepared by the WWC using version 2.1, 3.0, 4.0, or 4.1 of the WWC Handbooks reporting a “positive effect” or “potentially positive effect” on a relevant outcome based on a “medium to large” extent of evidence, with no reporting of a “negative effect” or “potentially negative effect” on a relevant outcome; or

(iii) A single experimental study or quasi-experimental design study reviewed and reported by the WWC using version 2.1, 3.0, 4.0, or 4.1 of the WWC Handbooks, or otherwise assessed by the Department using version 4.1 of the WWC Handbooks, as appropriate, and that—

(A) Meets WWC standards with or without reservations;

(B) Includes at least one statistically significant and positive ( i.e., favorable) effect on a relevant outcome;

(C) Includes no overriding statistically significant and negative effects on relevant outcomes reported in the study or in a corresponding WWC intervention report prepared under version 2.1, 3.0, 4.0, or 4.1 of the WWC Handbooks; and

(D) Is based on a sample from more than one site ( e.g., State, county, city, school district, or postsecondary campus) and includes at least 350 students or other individuals across sites. Multiple studies of the same project component that each meet requirements in paragraphs (iii)(A), (B), and (C) of this definition may together satisfy the requirement in this paragraph (iii)(D).

Project component means an activity, strategy, intervention, process, product, practice, or policy included in a project. Evidence may pertain to an individual project component or to a combination of project components ( e.g., training teachers on instructional practices for English learners and follow-on coaching for these teachers).

Quasi-experimental design study means a study using a design that attempts to approximate an experimental study by identifying a comparison group that is similar to the treatment group in important respects. This type of study, depending on design and implementation ( e.g., establishment of baseline equivalence of the groups being compared), can meet WWC standards with reservations, as described in the WWC Handbooks.

Relevant outcome means the student outcome(s) or other outcome(s) the key project component is designed to improve, consistent with the specific goals of a program.

What Works Clearinghouse (WWC) Handbooks (WWC Handbooks) means the standards and procedures set forth in the WWC Standards Handbook, Versions 4.0 or 4.1, and WWC Procedures Handbook, Versions 4.0 or 4.1, or in the WWC Procedures and Standards Handbook, Version 3.0 or Version 2.1 (all incorporated by reference, see § 77.2). Study findings eligible for review under WWC standards can meet WWC standards without reservations, meet WWC standards with reservations, or not meet WWC standards. WWC practice guides and intervention reports include findings from systematic reviews of evidence as described in the WWC Handbooks documentation.

Program Authority: 20 U.S.C. 1070a-21-1070a-28.

Applicable Regulations: (a) The Education Department General Administrative Regulations (EDGAR) in 34 CFR parts 75, 77, 79, 81, 82, 84, 97, 98, and 99. (b) The Office of Management and Budget Guidelines to Agencies on Governmentwide Debarment and Suspension (Nonprocurement) in 2 CFR part 180, as adopted and amended as regulations of the Department in 2 CFR part 3485. (c) The Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards in 2 CFR part 200, as adopted and amended as regulations of the Department in 2 CFR part 3474. (d) The regulations for this program in 34 CFR part 694.

Type of Award: Discretionary grants.

Estimated Available Funds: $35,617,582.

Contingent upon the availability of funds and the quality of applications, we may make additional awards in subsequent years from the list of unfunded applications from this competition.

Estimated Range of Awards: $2,500,000-$5,000,000.

Estimated Average Size of Awards: $3,535,000.

Maximum Award: We will not make an award for a State grant exceeding $5,000,000 for a single budget period of 12 months. Additionally, no funding will be awarded for increases in years two through seven.

Estimated Number of Awards: 11.

Project Period: Either 72 months or 84 months.

1. Eligible Applicants: States (as defined in section 103(20) of the HEA (20 U.S.C. 1003(20)), which includes the Commonwealth of Puerto Rico, the District of Columbia, Guam, American Samoa, the United States Virgin Islands, the Commonwealth of the Northern Mariana Islands, and the Freely Associated States. Per congressional direction in House Report 116-450 and reinforced in the Explanatory Statement to the Department of Education Appropriations Act, 2021 (Pub. L. 116-260), only States without an active State GEAR UP grant, or States that have an active State GEAR UP grant that is scheduled to end prior to October 1, 2021, are eligible to receive a new State GEAR UP award in this competition. States with grants remaining open beyond October 1, 2021, for a no-cost extension period or for the sole purpose of data collection and analysis activities, are not considered active for purposes of implementing this directive.

2. a. Cost Sharing or Matching: Section 404C(b)(1) of the HEA requires grantees under this program to provide from State, local, institutional, or private funds, not less than 50 percent of the cost of the program (or one dollar of non-Federal funds for every one dollar of Federal funds awarded), which may be provided in cash or in-kind. The provision also specifies that the match may be accrued over the full duration of the grant award period, except that the grantee must make substantial progress towards meeting the matching requirement in each year of the grant award period.

Section 404C(c) of the HEA provides that in-kind contributions may include (1) the amount of the financial assistance obligated under GEAR UP to students from State, local, institutional, or private funds, (2) the amount of tuition, fees, room or board waived or reduced for recipients of financial assistance under GEAR UP, (3) the amount expended on documented, targeted, long-term mentoring and counseling provided by volunteers or paid staff of non-school organizations, including businesses, religious organizations, community groups, postsecondary educational institutions, nonprofit and philanthropic organizations, and other organizations, and (4) equipment and supplies, cash contributions from non-Federal sources, transportation expenses, in-kind or discounted program services, indirect costs, and facility usage.

Grantees must include a budget detailing the source of the matching funds and must provide an outline of the types of matching contributions for at least the first year of the grant in their grant applications. Consistent with 2 CFR 200.306(b), any matching funds must be an allowable use of funds consistent with the GEAR UP program requirements and the cost principles detailed in subpart E of 2 CFR part 200, and not included as a contribution for any other Federal award.

b. Supplement-Not-Supplant: This program involves supplement, not supplant funding requirements. Under section 404B(e) of the HEA (20 U.S.C. 1070a-22(e)), grant funds awarded under this program must be used to supplement, and not supplant, other Federal, State, and local funds that would otherwise be expended to carry out activities assisted under this program.

c. Indirect Cost Rate Information: For entities eligible to apply to this competition, the program regulations at 34 CFR 694.11 limit indirect cost reimbursement to the rate determined in the entity's negotiated indirect cost rate agreement, or eight percent of a modified total direct cost base, whichever amount is less. For more information regarding indirect costs, or to obtain a negotiated indirect cost rate, please see www2.ed.gov/about/offices/list/ocfo/intro.html.

d. Administrative Cost Limitation: This program does not include any program-specific limitation on administrative expenses. All administrative expenses must be reasonable and necessary and conform to Cost Principles described in 2 CFR part 200 subpart E of the Uniform Guidance.

3. Other: General Application Requirements: All applicants must meet the following application requirements in order to be considered for funding. The application requirements are from sections 404C(a) and 404E of the HEA (20 U.S.C. 1070a-23(a); 20 U.S.C. 1070a-25).

In order for an eligible entity to qualify for a grant under the GEAR UP program, the eligible entity must submit to the Secretary an application for carrying out a GEAR UP program that—

(a) Describes the activities for which assistance under this program is sought, including how the eligible entity will carry out the required activities described in section 404D(a) of the HEA;

(b) Describes, in the case of an eligible entity described in section 404A(c)(1) of the HEA, how the eligible entity will meet the requirements of section 404E of the HEA;

(c) Provides assurances that adequate administrative and support staff will be responsible for coordinating the activities described in section 404D of the HEA;

(d) Provides assurances that activities assisted under this program will not displace an employee or eliminate a position at a school assisted under this program, including a partial displacement such as a reduction in hours, wages, or employment benefits;

(e) Describes, in the case of an eligible entity described in section 404A(c)(1) of the HEA that chooses to use a cohort approach, how the eligible entity will define the cohorts of the students served by the eligible entity pursuant to section 404B(d) of the HEA, and how the eligible entity will serve the cohorts through grade 12, including—

(i) How vacancies in the program under this program will be filled; and

(ii) How the eligible entity will serve students attending different secondary schools;

(f) Describes how the eligible entity will coordinate programs under this program with other existing Federal, State, or local programs to avoid duplication and maximize the number of students served;

(g) Provides such additional assurances as the Secretary determines necessary to ensure compliance with the requirements of this program;

(h) Provides information about the activities that will be carried out by the eligible entity to support systemic changes from which future cohorts of students will benefit;

(i) Describes the sources of matching funds that will enable the eligible entity to meet the matching requirement described in section 404C(b); and

(j) Demonstrates, in the case of an eligible entity that is requesting to use more than 50 percent of grant funds on GEAR UP early intervention activities and less than 50 percent of grant funds on scholarships, that the eligible entity has another means of providing the students with GEAR UP scholarships. Such means must ensure that (1) any student that qualifies as a student eligible for a GEAR UP scholarship under 20 U.S.C. 1070a-25(g) will receive a scholarship that meets the minimum Pell Grant requirements under 20 U.S.C. 1070a-25(d), and (2) the eligible entity will not impose additional eligibility criteria that would have the effect of limiting or denying a scholarship to an eligible student as required by 34 CFR 694.14(c)(3).

4. Subgrantees: A grantee under this competition may not award subgrants to entities to directly carry out project activities described in its application.

1. Application Submission Instructions: Applicants are required to follow the Common Instructions for Applicants to Department of Education Discretionary Grant Programs, published in the Federal Register on February 13, 2019 (84 FR 3768) and available at www.govinfo.gov/content/pkg/FR-2019-02-13/pdf/2019-02206.pdf, which contain requirements and information on how to submit an application.

2. Intergovernmental Review: This program is subject to Executive Order 12372 and the regulations in 34 CFR part 79. Information about Intergovernmental Review of Federal Programs under Executive Order 12372 is in the application package for this program.

3. Funding Restrictions: We specify unallowable costs in subpart E of 2 CFR part 200. We reference regulations outlining funding restrictions in the Applicable Regulations section of this notice.

Under HEA section 404E(b)(1), a State must use not less than 25 percent and not more than 50 percent of the grant funds for GEAR UP project activities described in HEA section 404D, 6 with the remainder of grant funds spent on scholarships to eligible GEAR UP students described in HEA section 404E. However, HEA section 404E(b)(2) permits the Secretary to allow a State to use more than 50 percent of grant funds received under this program for GEAR UP project activities described in HEA section 404D if the State demonstrates that it has another means of providing eligible GEAR UP students with the financial assistance described in HEA section 404E and describes such means in the State's application.

4. Recommended Page Limit: The application narrative is where you, the applicant, address the selection criteria that reviewers use to evaluate your application. We recommend that you (1) limit the application narrative to no more than 65 pages and (2) use the following standards:

• A “page″ is 8.5″ x 11″, on one side only, with 1” margins at the top, bottom, and both sides.

• Double-space (no more than three lines per vertical inch) all text in the application narrative, including titles, headings, footnotes, quotations, references, captions as well as all text in charts, tables, figures, and graphs.

• Use a font that is either 12-point font or larger or no smaller than 10 pitch (characters per inch).

• Use one of the following fonts: Times New Roman, Courier, Courier New, or Arial.

The recommended page limit does not apply to the cover sheet; the budget section, including the narrative budget justification; the assurances and certifications or the one-page abstract. However, the recommended page limit does apply to all of the application narrative.

We recommend that any application addressing the competitive preference priorities and invitational priorities include no more than three additional pages for each priority addressed. Applicants that do not follow the page limit and formatting recommendations will not be penalized.

1. Selection Criteria: The selection criteria for this competition are from 34 CFR 75.210 and section 404D(a) of the HEA.

a. Need for project (15 points).

(i) The Secretary considers the need for the proposed project.

(ii) In determining the need for the proposed project, the Secretary considers:

(A) The magnitude or severity of the problem to be addressed by the proposed project (up to 8 points); and

(B) The extent to which specific gaps or weaknesses in services, infrastructure, or opportunities have been identified and will be addressed by the proposed project, including the nature and magnitude of those gaps or weaknesses (up to 7 points).

b. Quality of the project design (25 points).

(i) The Secretary considers the quality of the design of the proposed project.

(ii) In determining the quality of the design of the proposed project, the Secretary considers:

(A) The extent to which the goals, objectives, and outcomes to be achieved by the proposed project are clearly specified and measurable (up to 10 points); and

(B) The extent to which the proposed project demonstrates a rationale (as defined in this notice) (up to 15 points).

c. Quality of project services (15 points).

(i) The Secretary considers the quality of the services to be provided by the proposed project.

(ii) In determining the quality of the services to be provided by the proposed project, the Secretary considers the quality and sufficiency of strategies for ensuring equal access and treatment for eligible project participants who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability (up to 5 points).

(iii) In addition, the Secretary considers:

(A) The extent to which the project services are likely to provide comprehensive mentoring, outreach, and supportive services to students, including the following activities: providing information regarding financial aid for postsecondary education to participating students, encouraging student enrollment in rigorous and challenging curricula and coursework in order to reduce the need for remedial coursework at the postsecondary level, and improving the number of participating students who obtain a secondary school diploma and complete applications for and enroll in a program of postsecondary education (up to 5 points); and

(B) The extent to which the services to be provided by the proposed project involve the collaboration of appropriate partners for maximizing the effectiveness of project services (up to 5 points).

d. Quality of project personnel (10 points).

(i) The Secretary considers the quality of the personnel who will carry out the proposed project.

(ii) In determining the quality of project personnel, the Secretary considers the extent to which the applicant encourages applications for employment from persons who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability (up to 2 points).

(iii) In addition, the Secretary considers:

(A) The qualifications, including relevant training and experience, of the project director or principal investigator (up to 4 points); and

(B) The qualifications, including relevant training and experience, of key project personnel (up to 4 points).

e. Quality of the management plan (10 points).

(i) The Secretary considers the quality of the management plan for the proposed project.

(ii) In determining the quality of the management plan for the proposed project, the Secretary considers:

(A) The adequacy of the management plan to achieve the objectives of the proposed project on time and within budget, including clearly defined responsibilities, timelines, and milestones for accomplishing project tasks (up to 4 points);

(B) The adequacy of procedures for ensuring feedback and continuous improvement in the operation of the proposed project (up to 2 points);

(C) The extent to which the time commitments of the project director and principal investigator and other key project personnel are appropriate and adequate to meet the objectives of the proposed project (up to 2 points); and

(D) How the applicant will ensure that a diversity of perspectives are brought to bear in the operation of the proposed project, including those of parents, teachers, the business community, a variety of disciplinary and professional fields, recipients or beneficiaries of services, or others, as appropriate (up to 2 points).

f. Quality of the project evaluation (10 points).

(i) The Secretary considers the quality of the evaluation to be conducted of the proposed project.

(ii) In determining the quality of the project evaluation, the Secretary considers:

(A) The extent to which the methods of evaluation include the use of objective performance measures that are clearly related to the intended outcomes of the project and will produce quantitative and qualitative data to the extent possible (up to 4 points);

(B) The extent to which the methods of evaluation will provide performance feedback and permit periodic assessment of progress toward achieving intended outcomes (up to 4 points); and

(C) The extent to which the evaluation will provide guidance about effective strategies suitable for replication or testing in other settings (up to 2 points).

g. Adequacy of resources (15 points).

(i) The Secretary considers the adequacy of resources for the proposed project.

(ii) In determining the adequacy of resources for the proposed project, the Secretary considers:

(A) The adequacy of support, including facilities, equipment, supplies and other resources from the applicant organization or the lead applicant organization and the relevance and demonstrated commitment of each partner in the proposed project to the implementation and success of the project (up to 5 points);

(B) The extent to which the costs are reasonable in relation to the number of persons to be served and to the anticipated results and benefits (up to 5 points); and

(C) The potential for continued support of the project after Federal funding ends, including, as appropriate, the demonstrated commitment of appropriate entities to such support (up to 5 points).

2. Review and Selection Process: We remind potential applicants that in reviewing applications in any discretionary grant competition, the Secretary may consider, under 34 CFR 75.217(d)(3), the past performance of the applicant in carrying out a previous award, such as the applicant's use of funds, achievement of project objectives, and compliance with grant conditions. The Secretary may also consider whether the applicant failed to submit a timely performance report or submitted a report of unacceptable quality.

In addition, in making a competitive grant award, the Secretary requires various assurances including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).

For this competition, a panel of non-Federal reviewers will review each application in accordance with the selection criteria in 34 CFR 75.217(d)(3), as required by 20 U.S.C. 1070-a23(d). The individual scores of the reviewers will be added and the sum divided by the number of reviewers to determine the peer review score received in the review process.

If there are insufficient funds for all applications with the same total scores, the Secretary will, to the extent practicable, consider the distribution of grant awards based on the geographic distribution of such grant awards and the distribution between urban and rural applicants for the GEAR UP program consistent with 20 U.S.C. 1070a-22(a)(3).

3. Risk Assessment and Specific Conditions: Consistent with 2 CFR 200.206, before awarding grants under this competition the Department conducts a review of the risks posed by applicants. Under 2 CFR 200.208, the Secretary may impose specific conditions and, under 2 CFR 3474.10, in appropriate circumstances, high-risk conditions on a grant if the applicant or grantee is not financially stable; has a history of unsatisfactory performance; has a financial or other management system that does not meet the standards in 2 CFR part 200, subpart D; has not fulfilled the conditions of a prior grant; or is otherwise not responsible.

4. Integrity and Performance System: If you are selected under this competition to receive an award that over the course of the project period may exceed the simplified acquisition threshold (currently $250,000), under 2 CFR 200.206(a)(2) we must make a judgment about your integrity, business ethics, and record of performance under Federal awards—that is, the risk posed by you as an applicant—before we make an award. In doing so, we must consider any information about you that is in the integrity and performance system (currently referred to as the Federal Awardee Performance and Integrity Information System (FAPIIS)), accessible through the System for Award Management. You may review and comment on any information about yourself that a Federal agency previously entered and that is currently in FAPIIS.

Please note that, if the total value of your currently active grants, cooperative agreements, and procurement contracts from the Federal Government exceeds $10,000,000, the reporting requirements in 2 CFR part 200, Appendix XII, require you to report certain integrity information to FAPIIS semiannually. Please review the requirements in 2 CFR part 200, Appendix XII, if this grant plus all the other Federal funds you receive exceed $10,000,000.

5. In General: In accordance with the Office of Management and Budget's guidance located at 2 CFR part 200, all applicable Federal laws, and relevant Executive guidance, the Department will review and consider applications for funding pursuant to this notice inviting applications in accordance with—

(a) Selecting recipients most likely to be successful in delivering results based on the program objectives through an objective process of evaluating Federal award applications (2 CFR 200.205);

(b) Prohibiting the purchase of certain telecommunication and video surveillance services or equipment in alignment with section 889 of the National Defense Authorization Act of 2019 (Pub. L. 115-232) (2 CFR 200.216);

(c) Providing a preference, to the extent permitted by law, to maximize use of goods, products, and materials produced in the United States (2 CFR 200.322); and

(d) Terminating agreements in whole or in part to the greatest extent authorized by law if an award no longer effectuates the program goals or agency priorities (2 CFR 200.340).

1. Award Notices: If your application is successful, we notify your U.S. Representative and U.S. Senators and send you a Grant Award Notification (GAN), or we may send you an email containing a link to access an electronic version of your GAN. We may notify you informally, also.

If your application is not evaluated or not selected for funding, we will notify you.

2. Administrative and National Policy Requirements: We identify administrative and national policy requirements in the application package and reference these and other requirements in the Applicable Regulations section of this notice.

We reference the regulations outlining the terms and conditions of an award in the Applicable Regulations section of this notice and include these and other specific conditions in the GAN. The GAN also incorporates your approved application as part of your binding commitments under the grant.

3. Open Licensing Requirements: Unless an exception applies, if you are awarded a grant under this competition, you will be required to openly license to the public grant deliverables created in whole, or in part, with Department grant funds. When the deliverable consists of modifications to pre-existing works, the license extends only to those modifications that can be separately identified and only to the extent that open licensing is permitted under the terms of any licenses or other legal restrictions on the use of pre-existing works. Additionally, a grantee or subgrantee that is awarded competitive grant funds must have a plan to disseminate these public grant deliverables. This dissemination plan can be developed and submitted after your application has been reviewed and selected for funding. For additional information on the open licensing requirements please refer to 2 CFR 3474.20.

4. Reporting: (a) If you apply for a grant under this competition, you must ensure that you have in place the necessary processes and systems to comply with the reporting requirements in 2 CFR part 170 should you receive funding under the competition. This does not apply if you have an exception under 2 CFR 170.110(b).

(b) At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multiyear award, you must submit an annual performance report that provides the most current performance and financial expenditure information as directed by the Secretary under 34 CFR 75.118. The Secretary may also require more frequent performance reports under 34 CFR 75.720(c). For specific requirements on reporting, please go to www.ed.gov/fund/grant/apply/appforms/appforms.html.

(c) Under 34 CFR 75.250(b), the Secretary may provide a grantee with additional funding for data collection analysis and reporting. In this case the Secretary establishes a data collection period.

5. Performance Measures: The performance measures for the GEAR UP Program are established for the Government Performance and Results Act of 1993 (GPRA). These measures are also used for Department reporting under 34 CFR 75.110. The objectives of the GEAR UP program are (1) to increase the academic performance and preparation for postsecondary education of participating students; (2) to increase the rate of high school graduation and participation in postsecondary education of participating students; and (3) to increase education expectations for participating students and increase student and family knowledge of postsecondary education options, preparation, and financing.

The effectiveness of this program depends on the rate at which program participants complete high school and enroll in and complete a postsecondary education. Under GPRA, we developed the following performance measures to track progress toward achieving the program's goals:

1. The percentage of GEAR UP students who pass Algebra 1 or its equivalent by the end of ninth grade.

2. The percentage of GEAR UP students who graduate from high school.

3. The percentage of GEAR UP students who complete the Free Application for Federal Student Aid.

4. The percentage of GEAR UP students and former GEAR UP students who are enrolled at an IHE.

5. The percentage of current GEAR UP students and former GEAR UP students who enrolled at an IHE and persisted to the second year of postsecondary education at the initial or a subsequent IHE.

In addition, to assess the efficiency of the program, we track the average cost, in Federal funds, of achieving a successful outcome, where success is defined as enrollment in a program of undergraduate instruction at an IHE of GEAR UP students immediately after high school graduation. These performance measures constitute GEAR UP's indicators of the success of the program. Accordingly, we require that applicants include these performance measures in conceptualizing the design, implementation, and evaluation of their proposed projects.

6. Continuation Awards: In making a continuation award under 34 CFR 75.253, the Secretary considers, among other things: whether a grantee has made substantial progress in achieving the goals and objectives of the project; whether the grantee has expended funds in a manner that is consistent with its approved application and budget; and, if the Secretary has established performance measurement requirements, the performance targets in the grantee's approved application.

In making a continuation grant, the Secretary also considers whether the grantee is operating in compliance with the assurances in its approved application, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).

Accessible Format: On request to the program contact person listed under FOR FURTHER INFORMATION CONTACT , individuals with disabilities can obtain this document and a copy of the application package in an accessible format. The Department will provide the requestor with an accessible format that may include Rich Text Format (RTF) or text format (txt), a thumb drive, an MP3 file, braille, large print, audiotape, or compact disc, or other accessible format.

Electronic Access to This Document: The official version of this document is the document published in the Federal Register . You may access the official edition of the Federal Register and the Code of Federal Regulations at www.govinfo.gov. At this site you can view this document, as well as all other documents of this Department published in the Federal Register , in text or Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

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: Application for the Business and International Education (BIE) Program (1894-0001).

OMB Control Number: 1840-0794.

Type of Review: Reinstatement with change of a previously approved collection.

Respondents/Affected Public: Private Sector.

Total Estimated Number of Annual Responses: 100.

Total Estimated Number of Annual Burden Hours: 11,000.

Abstract: The Business and International Education program provides grants to institutions of higher education that enter into an agreement with a trade association to improve the academic teaching of the business curriculum and to conduct outreach activities that will assist the local business community to compete in the global arena. This collection is being submitted under the Streamlined Clearance Process for Discretionary Grant Information Collections (1894-0001). Therefore, the 30-day public comment period notice will be the only public comment notice published for this information collection request.

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: Federal Student Loan Program: Internship/Residency and Loan Debt Burden Forbearance Forms.

OMB Control Number: 1845-0018.

Type of Review: Extension without change of a currently approved collection.

Respondents/Affected Public: Individuals or Households. Total Estimated Number of Annual Responses: 27,042.

Total Estimated Number of Annual Burden Hours: 6,393.

Abstract: These forms serve as the means by which borrowers in the William D. Ford Federal Direct Loan (Direct Loan), Federal Family Education Loan (FFEL) and the Federal Perkins Loan (Perkins Loan) Programs may request forbearance of repayment on their loans if they meet certain conditions. The U.S. Department of Education and other loan holders uses the information collected on these forms to determine whether a borrower meets the eligibility requirements for the specific type of forbearance.

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: Office of Special Education and Rehabilitative Services Peer Reviewer Data Form.

OMB Control Number: 1820-0583.

Type of Review: An extension without change of a currently approved collection.

Respondents/Affected Public: Individuals and Households.

Total Estimated Number of Annual Responses: 350.

Total Estimated Number of Annual Burden Hours: 88.

Abstract: The OSERS Peer Reviewer Data Form (OPRDF) is used by OSERS staff to identify potential reviewers who would be qualified to review specific types of grant applications for funding. OSERS uses this form to collect background contact information for each potential reviewer; and to provide information on any reasonable accommodations that might be required by the individual. OSERS is requesting an extension of the expiration date with no changes to the form. The previous version of the OPRDF, 1820-0583, will expire on May 31, 2021.

Full Text of Announcement I. Funding Opportunity Description

Purpose of Program: The GEAR UP program is a discretionary grant program that encourages eligible entities to provide support, and maintain a commitment, to eligible low-income students, including students with disabilities, to assist the students in obtaining a secondary school diploma (or its recognized equivalent) and to prepare for and succeed in postsecondary education. Under the GEAR UP program, the Department awards grants to two types of entities: (1) States and (2) partnerships consisting of at least one institution of higher education (IHE) and at least one local educational agency (LEA).

Background: In this notice, the Department invites applications for partnership grants only. We will invite applications for State grants in another notice published in the Federal Register . Required services under the GEAR UP program are specified in section 404D(a) of the Higher Education Act of 1965, as amended (HEA) (20 U.S.C. 1070a-24(a)), and permissible services under the GEAR UP program are specified in section 404D(b) of the HEA (20 U.S.C. 1070a-24(b)). For partnership grantees, activities must include providing financial aid information for postsecondary education, encouraging enrollment in rigorous and challenging coursework in order to reduce the need for remediation at the postsecondary level, and implementing activities to improve the number of participating students who obtain a secondary school diploma and who complete applications for and enroll in a program of postsecondary education. Activities may also include mentoring; tutoring; supporting dual or concurrent enrollment programs that support participating students in science, technology, engineering, or mathematics (STEM); academic and career counseling; financial and economic literacy education; and exposure to college campuses.

Recent data suggest that the COVID-19 pandemic has created academic challenges and greatly exacerbated mental health issues among school-aged youth. For example, the Centers for Disease Control (CDC) reports the proportion of emergency room visits related to mental health crises has increased dramatically for young children and adolescents since the start of the pandemic. 1 Researchers also estimate that COVID-19-related disruptions may put students substantially behind, particularly in topics like mathematics, causing many to reenter school with more variability in their academic skills compared to normal circumstances. 2

In addition, the transition to remote learning has introduced academic challenges for all students, particularly students from low-income backgrounds, students of color, English learners, and students with disabilities. Students living in rural communities face additional challenges to accessing instruction. Across the Nation, there are gaps in access to broadband in rural locations and on Tribal lands. In addition to less access to academic instruction, COVID-19 has impacted the well-being of rural students  3 and their likelihood of enrolling in postsecondary education. 4

Priorities: This notice contains two competitive preference priorities and three invitational priorities. Competitive Preference Priority 1 is from the Secretary's Final Supplemental Priorities and Definitions for Discretionary Grant Programs published in the Federal Register on March 2, 2018 (83 FR 9096) (Supplemental Priorities). Competitive Preference Priority 2 is from 34 CFR 75.226.

Competitive Preference Priorities: For FY 2021 and any subsequent year in which we make awards from the list of unfunded applications from this competition, these priorities are competitive preference priorities. Under 34 CFR 75.105(c)(2)(i), we award up to an additional five points to an application depending on how well the application meets the priorities.

These priorities are:

Competitive Preference Priority 1—Fostering Flexible and Affordable Paths to Obtaining Knowledge and Skills (up to 3 points).

Projects that are designed to provide work-based learning experiences (such as internships, apprenticeships, and fellowships) that align with in-demand industry sectors or occupations (as defined in section 3(23) of the Workforce Innovation and Opportunity Act of 2014).

Competitive Preference Priority 2—Promising Evidence (up to 2 points).

Applications supported by evidence that meets the conditions in the definition of “promising evidence” in 34 CFR 77.1(c).

Non-Federal peer reviewers will evaluate studies cited by the applicants to determine if they meet the requirements for promising evidence, as well as whether they are sufficiently aligned with (relevant to) the proposed activity. Applicants will be awarded one point for each authorized activity supported by a relevant citation that meets the promising evidence standard, for a maximum of two points.

Cited studies may include both those already listed in the Department's WWC Database of Individual Studies (see https://ies.ed.gov/ncee/wwc/StudyFindings ) and those that have not yet been reviewed by the WWC. Studies listed in the WWC Database of Individual Studies do not necessarily satisfy any or all of the criteria needed to meet the promising evidence standard. Therefore, it is important that applicants themselves ascertain the suitability of the study for the evidence priority. Any proposed studies must be cited in the section of the application that addresses Competitive Preference Priority 2.

Invitational Priorities: For FY 2021, and any subsequent year in which we make awards from the list of unfunded applications from this competition, these priorities are invitational priorities. Under 34 CFR 75.105 (c)(1) we do not give an application that meets these invitational priorities a competitive or absolute preference over other applications.

These priorities are:

Invitational Priority 1—Building Capacity for Remote Learning.

Projects that are designed to address one or both of the following priority areas:

(a) Providing personalized and job-embedded professional learning to build the capacity of GEAR UP educators who serve GEAR UP participants to create remote learning experiences for GEAR UP participants that advance student engagement and learning through effective use of technology ( e.g., both live and video conferencing professional learning opportunities, professional learning networks or communities, and coaching).

(b) Providing access to software applications to GEAR UP participants without access to such software applications to meet all GEAR UP students' and GEAR UP educators' remote learning needs, regardless of whether students and educators are inside the school building or in remote learning environments.

For the purposes of this priority, “remote learning” means programming where at least part of the learning occurs away from the physical building in a manner that addresses a learner's education needs. Remote learning may include online, hybrid/blended learning, or non-technology-based learning ( e.g., lab kits, project supplies, paper packets).

Invitational Priority 2—Addressing the Impact of COVID-19 on Students' Mental Health and Academic Outcomes.

Projects designed to provide integrated student support services (also known as wrap-around services) for GEAR UP participants to address mental health and academic support needs due to the COVID-19 pandemic. An applicant should describe in its application how it will collaborate with any partners to provide resources to support students and communities hit the hardest by COVID-19 and implement evidence-based best practices to address the existing inequities exacerbated by the pandemic. The proposed system of integrated student support services should include services that meet the whole needs of students from low-income backgrounds, including aid for school supplies, transportation costs as allowable by program regulations, connections to mental health services, mentoring, tutoring, and peer support groups, that help ensure graduation from high school and enrollment in postsecondary education.

Invitational Priority 3—Providing GEAR UP Services to Schools Located in Rural Areas.

Applications that include descriptive plans to provide GEAR UP services and resources in rural communities and schools, including those local educational agencies (LEAs) with a locale code of 32, 33, 41, 42, or 43.

Definitions: These definitions are from 34 CFR 77.1(c).

Demonstrates a rationale means a key project component included in the project's logic model is informed by research or evaluation findings that suggest the project component is likely to improve relevant outcomes.

Experimental study means a study that is designed to compare outcomes between two groups of individuals (such as students) that are otherwise equivalent except for their assignment to either a treatment group receiving a project component or a control group that does not. Randomized controlled trials, regression discontinuity design studies, and single-case design studies are the specific types of experimental studies that, depending on their design and implementation ( e.g., sample attrition in randomized controlled trials and regression discontinuity design studies), can meet What Works Clearinghouse (WWC) standards without reservations as described in the WWC Handbooks:

(i) A randomized controlled trial employs random assignment of, for example, students, teachers, classrooms, or schools to receive the project component being evaluated (the treatment group) or not to receive the project component (the control group).

(ii) A regression discontinuity design study assigns the project component being evaluated using a measured variable ( e.g., assigning students reading below a cutoff score to tutoring or developmental education classes) and controls for that variable in the analysis of outcomes.

(iii) A single-case design study uses observations of a single case ( e.g., a student eligible for a behavioral intervention) over time in the absence and presence of a controlled treatment manipulation to determine whether the outcome is systematically related to the treatment.

Logic model (also referred to as a theory of action) means a framework that identifies key project components of the proposed project ( i.e., the active “ingredients” that are hypothesized to be critical to achieving the relevant outcomes) and describes the theoretical and operational relationships among the key project components and relevant outcomes.

Project component means an activity, strategy, intervention, process, product, practice, or policy included in a project. Evidence may pertain to an individual project component or to a combination of project components ( e.g., training teachers on instructional practices for English learners and follow-on coaching for these teachers).

Promising evidence means that there is evidence of the effectiveness of a key project component in improving a relevant outcome, based on a relevant finding from one of the following:

(i) A practice guide prepared by WWC reporting a “strong evidence base” or “moderate evidence base” for the corresponding practice guide recommendation;

(ii) An intervention report prepared by the WWC reporting a “positive effect” or “potentially positive effect” on a relevant outcome with no reporting of a “negative effect” or “potentially negative effect” on a relevant outcome; or

(iii) A single study assessed by the Department, as appropriate, that—

(A) Is an experimental study, a quasi-experimental design study, or a well-designed and well-implemented correlational study with statistical controls for selection bias ( e.g., a study using regression methods to account for differences between a treatment group and a comparison group); and

(B) Includes at least one statistically significant and positive ( i.e., favorable) effect on a relevant outcome.

Quasi-experimental design study means a study using a design that attempts to approximate an experimental study by identifying a comparison group that is similar to the treatment group in important respects. This type of study, depending on design and implementation ( e.g., establishment of baseline equivalence of the groups being compared), can meet WWC standards with reservations, but cannot meet WWC standards without reservations, as described in the WWC Handbooks.

Relevant outcome means the student outcome(s) or other outcome(s) the key project component is designed to improve, consistent with the specific goals of the program.

What Works Clearinghouse (WWC) Handbooks (WWC Handbooks) means the standards and procedures set forth in the WWC Standards Handbook, Versions 4.0 or 4.1, and WWC Procedures Handbook, Versions 4.0 or 4.1, or in the WWC Procedures and Standards Handbook, Version 3.0 or Version 2.1 (all incorporated by reference, see § 77.2). Study findings eligible for review under WWC standards can meet WWC standards without reservations, meet WWC standards with reservations, or not meet WWC standards. WWC practice guides and intervention reports include findings from systematic reviews of evidence as described in the WWC Handbooks documentation.

Program Authority: 20 U.S.C. 1070a-21—1070a-28.

Applicable Regulations: (a) The Education Department General Administrative Regulations (EDGAR) in 34 CFR parts 75, 77, 79, 81, 82, 84, 86, 97, 98, and 99. (b) The Office of Management and Budget Guidelines to Agencies on Governmentwide Debarment and Suspension (Nonprocurement) in 2 CFR part 180, as adopted and amended as regulations of the Department in 2 CFR part 3485. (c) The Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards in 2 CFR part 200, as adopted and amended as regulations of the Department in 2 CFR part 3474. (d) The regulations for this program in 34 CFR part 694. (e) The Supplemental Priorities.

Type of Award: Discretionary grants.

Estimated Available Funds: $35,617,582.

Contingent upon the availability of funds and the quality of applications, we may make additional awards in subsequent years from the list of unfunded applications from this competition.

Estimated Range of Awards: $100,000-$5,000,000.

Estimated Average Size of Awards: $1,200,000.

Maximum Award: We will not fund any application for a partnership grant above the maximum award of $800 per student for a single budget period of 12 months. Additionally, no funding will be awarded for increases in years two through seven.

Estimated Number of Awards: 28.

Project Period: Either 72 months or 84 months.

1. Eligible Applicants: Partnerships consisting of (a) at least one LEA and (b) at least one degree-granting IHE. Partnerships may include not less than two other community organizations or entities, such as businesses, professional organizations, State agencies, institutions or agencies sponsoring programs authorized under the Leveraging Educational Assistance Partnership Program authorized in part A, subpart 4, of title IV of the HEA (20 U.S.C. 1070c et seq. ), or other public or private agencies or organizations (20 U.S.C. 1070a-21(c)(2)).

2. a. Cost Sharing or Matching: Section 404C(b)(1) of the HEA requires grantees under this program to provide from State, local, institutional, or private funds, not less than 50 percent of the cost of the program (or one dollar of non-Federal funds for every one dollar of Federal funds awarded), which may be provided in cash or in-kind. The provision also specifies that the match may be accrued over the full duration of the grant award period, except that the grantee must make substantial progress towards meeting the matching requirement in each year of the grant award period. Section 404C(c) of the HEA provides that in-kind contributions may include (1) the amount of the financial assistance obligated under GEAR UP to students from State, local, institutional, or private funds, (2) the amount of tuition, fees, room or board waived or reduced for recipients of financial assistance under GEAR UP, (3) the amount expended on documented, targeted, long-term mentoring and counseling provided by volunteers or paid staff of non-school organizations, including businesses, religious organizations, community groups, postsecondary educational institutions, nonprofit and philanthropic organizations, and other organizations, and (4) equipment and supplies, cash contributions from non-Federal sources, transportation expenses, in-kind or discounted program services, indirect costs, and facility usage.

Section 404C(b)(2) further provides that the Secretary may approve a partnership's request for a reduced match percentage at the time of application if the partnership demonstrates significant economic hardship that precludes the partnership from meeting the matching requirement, or if the partnership requests that contributions to the scholarship fund be matched on the basis of two non-Federal dollars for every one Federal dollar of GEAR UP funds. GEAR UP program regulations in 34 CFR 694.8(a)-(c) address the content of an applicant's request for such a reduced match, and the maximum percentage match that the Secretary may waive. In addition, the Secretary may approve a reduction in match of up to 70 percent upon request from a partnership that (a) includes three or fewer IHEs as members (b) has a fiscal agent identified in 34 CFR 694.8(d)(1), and (c) serves students in schools and LEAs that meet the poverty criteria identified in 34 CFR 694.8(d)(2) and (3).

Given the importance of matching funds to the long-term success of the project, eligible entities must describe how they will meet the matching requirement and sources of matching funds, as required by General Application Requirements (b) and (j).

b. Supplement-Not-Supplant: This competition involves supplement, not supplant funding requirements. Under section 404B(e) of the HEA (20 U.S.C. 1070a-22(e)), grant funds awarded under this program must be used to supplement, and not supplant, other Federal, State, and local funds that would otherwise be expended to carry out activities assisted under this program.

c. Indirect Cost Rate Information: For projects that designate an LEA as the fiscal agent, the GEAR UP program regulations at 34 CFR 694.11 limit indirect cost reimbursement to the rate determined in the LEA's negotiated indirect cost rate agreement or eight percent of a modified total direct cost base, whichever amount is less. For projects that designate an IHE as the fiscal agent, the GEAR UP program uses a training indirect cost rate. This rate limits indirect cost reimbursement to an entity's actual indirect costs, as determined in its negotiated indirect cost rate agreement, or eight percent of a modified total direct cost base, whichever amount is less. For more information regarding training indirect cost rates, see 34 CFR 75.562. For more information regarding indirect costs, or to obtain a negotiated indirect cost rate, please see www2.ed.gov/about/offices/list/ocfo/intro.html.

d. Administrative Cost Limitation: This program does not include any program-specific limitation on administrative expenses. All administrative expenses must be reasonable and necessary and conform to Cost Principles described in 2 CFR part 200 subpart E of the Uniform Guidance.

3. Subgrantees: A grantee under this competition may not award subgrants to entities to directly carry out project activities described in its application.

4. Other: General Application Requirements: All applicants must meet the following application requirements in order to be considered for funding. The application requirements are from section 404C(a) of the HEA (20 U.S.C. 1070a-23(a)).

In order for an eligible entity to qualify for a grant under the GEAR UP program, the eligible entity must submit to the Secretary an application for carrying out a GEAR UP program that—

(a) Describes the activities for which assistance under this program is sought, including how the eligible entity will carry out the required activities described in section 404D(a) of the HEA;

(b) Describes, in the case of an eligible entity described in section 404A(c)(2) of the HEA that chooses to provide scholarships, or an eligible entity described in section 404A(c)(1) of the HEA, how the eligible entity will meet the requirements of section 404E of the HEA;

(c) Describes, in the case of an eligible entity described in section 404A(c)(2) of the HEA that requests a reduced match percentage under subsection (b)(2), how such reduction will assist the entity to provide the scholarships described in subsection (b)(2)(A)(ii);

(d) Provides assurances that adequate administrative and support staff will be responsible for coordinating the activities described in section 404D of the HEA;

(e) Provides assurances that activities assisted under this program will not displace an employee or eliminate a position at a school assisted under this program, including a partial displacement such as a reduction in hours, wages, or employment benefits;

(f) Describes, in the case of an eligible entity described in section 404A(c)(1) of the HEA that chooses to use a cohort approach, or an eligible entity described in section 404A(c)(2) of the HEA, how the eligible entity will define the cohorts of the students served by the eligible entity pursuant to section 404B(d) of the HEA, and how the eligible entity will serve the cohorts through grade 12, including—

(i) How vacancies in the program under this program will be filled; and

(ii) How the eligible entity will serve students attending different secondary schools;

(g) Describes how the eligible entity will coordinate programs under this program with other existing Federal, State, or local programs to avoid duplication and maximize the number of students served;

(h) Provides such additional assurances as the Secretary determines necessary to ensure compliance with the requirements of this program;

(i) Provides information about the activities that will be carried out by the eligible entity to support systemic changes from which future cohorts of students will benefit; and

(j) Describes the sources of matching funds that will enable the eligible entity to meet the matching requirement described in subsection (b).

1. Application Submission Instructions: Applicants are required to follow the Common Instructions for Applicants to Department of Education Discretionary Grant Programs, published in the Federal Register on February 13, 2019 (84 FR 3768) and available at www.govinfo.gov/content/pkg/FR-2019-02-13/pdf/2019-02206.pdf, which contain requirements and information on how to submit an application.

2. Intergovernmental Review: This program is subject to Executive Order 12372 and the regulations in 34 CFR part 79. Information about Intergovernmental Review of Federal Programs under Executive Order 12372 is in the application package for this program.

3. Funding Restrictions: We reference regulations outlining funding restrictions in the Applicable Regulations section of this notice.

4. Content and Form of Application Submission: You must include your complete response to the selection criteria and the competitive preference priorities in the application narrative. Other requirements concerning the content of an application, together with the forms you must submit, are in the application package for this program.

5. Recommended Page Limit: The application narrative is where you, the applicant, address the selection criteria that reviewers use to evaluate your application. We recommend that you (1) limit the application narrative to no more than 65 pages and (2) use the following standards:

• A “page” is 8.5″ x 11″, on one side only, with 1″ margins at the top, bottom, and both sides.

• Double space (no more than three lines per vertical inch) all the text in the application narrative, including titles, headings, footnotes, quotations, references, captions, as well as all text in charts, tables, figures, and graphs.

• Use a font that is either 12 point or larger or no smaller than 10 pitch (characters per inch).

• Use one of the following fonts: Times New Roman, Courier, Courier New, or Arial.

The recommended page limit does not apply to the cover sheet; the budget section, including the narrative budget justification; the assurances and certifications or the one-page abstract. However, the recommended page limit does apply to all of the application narrative.

We recommend that any application addressing the competitive preference priorities and invitational priorities include no more than three additional pages for each priority addressed. Applications that do not follow the page limit and formatting recommendations will not be penalized.

1. Selection Criteria: The selection criteria for this competition are from 34 CFR 75.210 and section 404D(a) of the HEA.

a. Need for project (15 points).

(i) The Secretary considers the need for the proposed project.

(ii) In determining the need for the proposed project, the Secretary considers:

(A) The magnitude or severity of the problem to be addressed by the proposed project (up to 8 points); and

(B) The extent to which specific gaps or weaknesses in services, infrastructure, or opportunities have been identified and will be addressed by the proposed project, including the nature and magnitude of those gaps or weaknesses (up to 7 points).

b. Quality of the project design (25 points).

(i) The Secretary considers the quality of the project design of the proposed project.

(ii) In determining the quality of project design of the proposed project, the Secretary considers:

(A) The extent to which the goals, objectives, and outcomes to be achieved by the proposed project are clearly specified and measurable (up to 10 points);

(B) The extent to which the proposed project demonstrates a rationale (as defined in this notice) (up to 15 points).

c. Quality of project services (15 points).

(i) The Secretary considers the quality of the services to be provided by the proposed project.

(ii) In determining the quality of project services provided by the proposed project, the Secretary considers the quality and sufficiency of strategies for ensuring equal access and treatment for eligible project participants who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability (up to 5 points).

(iii) In addition, the Secretary considers the following factors:

(A) The extent to which the project services are likely to provide comprehensive mentoring, outreach, and supportive services to students, including the following activities: information regarding financial aid for postsecondary education to participating students, encouraging student enrollment in rigorous and challenging curricula and coursework in order to reduce the need for remedial coursework at the postsecondary level, and improving the number of participating students who obtain a secondary school diploma and complete applications for and enroll in a program of postsecondary education (up to 5 points); and

(B) The extent to which the services to be provided by the proposed project involve the collaboration of appropriate partners for maximizing the effectiveness of project services (up to 5 points).

d. Quality of project personnel (10 points).

(i) The Secretary considers the quality of the personnel who will carry out the proposed project.

(ii) In determining the quality of project personnel, the Secretary considers the extent to which the applicant encourages applications for employment from persons who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age or disability (up to 2 points).

(iii) In addition, the Secretary considers:

(A) The qualifications, including relevant training and experience, of the project director or principal investigator (up to 4 points); and

(B) The qualifications, including relevant training and experience, of key project personnel (up to 4 points).

e. Quality of the management plan (10 points).

(i) The Secretary considers the quality of the management plan for the proposed project.

(ii) In determining the quality of the management plan for the proposed project, the Secretary considers:

(A) The adequacy of the management plan to achieve the objectives of the proposed project on time and within budget, including clearly defined responsibilities, timelines, and milestones for accomplishing project tasks (up to 4 points);

(B) The adequacy of procedures for ensuring feedback and continuous improvement in the operation of the proposed project (up to 2 points);

(C) The extent to which the time commitments of the project director and principal investigator and other key project personnel are appropriate and adequate to meet the objectives of the proposed project (up to 2 points); and

(D) How the applicant will ensure that a diversity of perspectives are brought to bear in the operation of the proposed project, including those of parents, teachers, the business community, a variety of disciplinary and professional fields, recipients or beneficiaries of services, or others, as appropriate (up to 2 points).

f. Quality of the project evaluation (10 points).

(i) The Secretary considers the quality of the evaluation to be conducted of the proposed project.

(ii) In determining the quality of the project evaluation, the Secretary considers the following factors:

(A) The extent to which the methods of evaluation include the use of objective performance measures that are clearly related to the intended outcomes of the project and will produce quantitative and qualitative data to the extent possible (up to 4 points);

(B) The extent to which the methods of evaluation will provide performance feedback and permit periodic assessment of progress toward achieving intended outcomes (up to 2 point); and

(C) The extent to which the evaluation will provide guidance about effective strategies suitable for replication or testing in other settings (up to 2 points); and

(D) The extent to which the methods of evaluation will, if well-implemented, produce promising evidence (as defined in this notice) about the project's effectiveness (up to 2 points).

g. Adequacy of resources (15 points).

(i) The Secretary considers the adequacy of resources for the proposed project.

(ii) In determining the adequacy of resources for the proposed project, the Secretary considers:

(A) The adequacy of support, including facilities, equipment, supplies and other resources from the applicant organization or the lead applicant organization and the relevance and demonstrated commitment of each partner in the proposed project to the implementation and success of the project (up to 5 points);

(B) The extent to which the costs are reasonable in relation to the number of persons to be served and to the anticipated results and benefits (up to 5 points); and

(C) The potential for continued support of the project after Federal funding ends, including, as appropriate, the demonstrated commitment of appropriate entities to such support (up to 5 points).

2. Review and Selection Process: We remind potential applicants that in reviewing applications in any discretionary grant competition, the Secretary may consider, under 34 CFR 75.217(d)(3), the past performance of the applicant in carrying out a previous award, such as the applicant's use of funds, achievement of project objectives, and compliance with grant conditions. The Secretary may also consider whether the applicant failed to submit a timely performance report or submitted a report of unacceptable quality.

In addition, in making a competitive grant award, the Secretary requires various assurances including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).

For this competition, a panel of non-Federal reviewers will review each application in accordance with the selection criteria in 34 CFR 75.217(d)(3) as required by 20 U.S.C. 1070-a23(d). The individual scores of the reviewers will be added and the sum divided by the number of reviewers to determine the peer review score received in the review process.

If there are insufficient funds for all applications with the same total scores, to the extent practicable the Secretary will consider the distribution of grant awards based on the geographic distribution of such grant awards and the distribution between urban and rural applicants for the GEAR UP program consistent with 20 U.S.C. 1070a-22(a)(3).

3. Risk Assessment and Special Conditions: Consistent with 2 CFR 200.206, before awarding grants under this competition the Department conducts a review of the risks posed by applicants. Under 2 CFR 200.208, the Secretary may impose special conditions and, under 2 CFR 3474.10, in appropriate circumstances, high-risk conditions on a grant if the applicant or grantee is not financially stable; has a history of unsatisfactory performance; has a financial or other management system that does not meet the standards in 2 CFR part 200, subpart D; has not fulfilled the conditions of a prior grant; or is otherwise not responsible.

4. Integrity and Performance System: If you are selected under this competition to receive an award that over the course of the project period may exceed the simplified acquisition threshold (currently $250,000), under 2 CFR 200.206(a)(2) we must make a judgment about your integrity, business ethics, and record of performance under Federal awards—that is, the risk posed by you as an applicant—before we make an award. In doing so, we must consider any information about you that is in the integrity and performance system (currently referred to as the Federal Awardee Performance and Integrity Information System (FAPIIS)), accessible through the System for Award Management. You may review and comment on any information about yourself that a Federal agency previously entered and that is currently in FAPIIS.

Please note that, if the total value of your currently active grants, cooperative agreements, and procurement contracts from the Federal Government exceeds $10,000,000, the reporting requirements in 2 CFR part 200, Appendix XII, require you to report certain integrity information to FAPIIS semiannually. Please review the requirements in 2 CFR part 200, Appendix XII, if this grant plus all the other Federal funds you receive exceed $10,000,000.

5. In General: In accordance with the Office of Management and Budget's guidance located at 2 CFR part 200, all applicable Federal laws, and relevant Executive guidance, the Department will review and consider applications for funding pursuant to this notice inviting applications in accordance with—

(a) Selecting recipients most likely to be successful in delivering results based on the program objectives through an objective process of evaluating Federal award applications (2 CFR 200.205);

(b) Prohibiting the purchase of certain telecommunication and video surveillance services or equipment in alignment with section 889 of the National Defense Authorization Act of 2019 (Pub. L. 115-232) (2 CFR 200.216);

(c) Providing a preference, to the extent permitted by law, to maximize use of goods, products, and materials produced in the United States (2 CFR 200.322); and

(d) Terminating agreements in whole or in part to the greatest extent authorized by law if an award no longer effectuates the program goals or agency priorities (2 CFR 200.340).

1. Award Notices: If your application is successful, we notify your U.S. Representative and U.S. Senators and send you a Grant Award Notification (GAN), or we may send you an email containing a link to access an electronic version of your GAN. We may notify you informally, also.

If your application is not evaluated or not selected for funding, we will notify you.

2. Administrative and National Policy Requirements: We identify administrative and national policy requirements in the application package and reference these and other requirements in the Applicable Regulations section of this notice.

We reference the regulations outlining the terms and conditions of an award in the Applicable Regulations section of this notice and include these and other specific conditions in the GAN. The GAN also incorporates your approved application as part of your binding commitments under the grant.

3. Open Licensing Requirements: Unless an exception applies, if you are awarded a grant under this competition, you will be required to openly license to the public grant deliverables created in whole, or in part, with Department grant funds. When the deliverable consists of modifications to pre-existing works, the license extends only to those modifications that can be separately identified and only to the extent that open licensing is permitted under the terms of any licenses or other legal restrictions on the use of pre-existing works. Additionally, a grantee or subgrantee that is awarded competitive grant funds must have a plan to disseminate these public grant deliverables. This dissemination plan can be developed and submitted after your application has been reviewed and selected for funding. For additional information on the open licensing requirements please refer to 2 CFR 3474.20.

4. Reporting: (a) If you apply for a grant under this competition, you must ensure that you have in place the necessary processes and systems to comply with the reporting requirements in 2 CFR part 170 should you receive funding under the competition. This does not apply if you have an exception under 2 CFR 170.110(b).

(b) At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multiyear award, you must submit an annual performance report that provides the most current performance and financial expenditure information as directed by the Secretary under 34 CFR 75.118. The Secretary may also require more frequent performance reports under 34 CFR 75.720(c). For specific requirements on reporting, please go to www.ed.gov/fund/grant/apply/appforms/appforms.html.

(c) Under 34 CFR 75.250(b), the Secretary may provide a grantee with additional funding for data collection analysis and reporting. In this case the Secretary establishes a data collection period.

5. Performance Measures: The performance measures for the GEAR UP Program are established for the Government Performance and Results Act of 1993 (GPRA) and used for Department reporting under 34 CFR 75.110. The objectives of the GEAR UP program are (1) to increase the academic performance and preparation for postsecondary education of participating students; (2) to increase the rate of high school graduation and participation in postsecondary education of participating students; and (3) to increase educational expectations for participating students and increase student and family knowledge of postsecondary education options, preparation, and financing.

The effectiveness of this program depends on the rate at which program participants complete high school and enroll in and complete a postsecondary education. Under GPRA, we developed the following performance measures to track progress toward achieving the program's goals:

1. The percentage of GEAR UP students who pass Algebra 1 or its equivalent by the end of ninth grade.

2. The percentage of GEAR UP students who graduate from high school.

3. The percentage of GEAR UP students who complete the Free Application for Federal Student Aid.

4. The percentage of GEAR UP students and former GEAR UP students who are enrolled at an IHE.

5. The percentage of current GEAR UP students and former GEAR UP students who enrolled at an IHE and persisted to the second year of postsecondary education at the initial or a subsequent IHE.

In addition, to assess the efficiency of the program, we track the average cost, in Federal funds, of achieving a successful outcome, where success is defined as enrollment in a program of undergraduate instruction at an IHE of GEAR UP students immediately after high school graduation. These performance measures constitute GEAR UP's indicators of the success of the program. Accordingly, we request that applicants include these performance measures in conceptualizing the design, implementation, and evaluation of their proposed projects.

6. Continuation Awards: In making a continuation award under 34 CFR 75.253, the Secretary considers, among other things: whether a grantee has made substantial progress in achieving the goals and objectives of the project; whether the grantee has expended funds in a manner that is consistent with its approved application and budget; and, if the Secretary has established performance measurement requirements, the performance targets in the grantee's approved application.

In making a continuation grant, the Secretary also considers whether the grantee is operating in compliance with the assurances in its approved application, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23) as well as all applicable requirements of all other Federal laws, executive orders, regulations, and policies governing this program.

Accessible Format: On request to the program contact person listed under FOR FURTHER INFORMATION CONTACT , individuals with disabilities can obtain this document and a copy of the application package in an accessible format. The Department will provide the requestor with an accessible format that may include Rich Text Format (RTF) or text format (txt), a thumb drive, an MP3 file, braille, large print, audiotape, or compact disc, or other accessible format.

Electronic Access to This Document: The official version of this document is the document published in the Federal Register . You may access the official edition of the Federal Register and the Code of Federal Regulations at www.govinfo.gov. At this site you can view this document, as well as all other documents of this Department published in the Federal Register , in text or Portal Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

Table of Contents 1.0 Introduction 2.0 Regional Docket Coordinators 3.0 Revisions of the Previous Docket 4.0 Process for Compiling the Updated Docket 5.0 Facilities Not Included 6.0 Facility NPL Status Reporting, Including NFRAP Status 7.0 Information Contained on Docket Listing 1.0 Introduction

Section 120(c) of CERCLA, 42 U.S.C. 9620(c), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), requires EPA to establish the Federal Agency Hazardous Waste Compliance Docket. The Docket contains information on Federal facilities that manage hazardous waste and such information is submitted by Federal agencies to EPA under sections 3005, 3010, and 3016 of the Resource Conservation and Recovery Act (RCRA), 42 U.S.C. 6925, 6930, and 6937. Additionally, the Docket contains information on Federal facilities with a reportable quantity of hazardous substances that has been released and such information is submitted by Federal agencies to EPA under section 103 of CERCLA, 42 U.S.C. 9603. Specifically, RCRA section 3005 establishes a permitting system for certain hazardous waste treatment, storage, and disposal (TSD) facilities; RCRA section 3010 requires waste generators, transporters and TSD facilities to notify EPA of their hazardous waste activities; and RCRA section 3016 requires Federal agencies to submit biennially to EPA an inventory of their Federal hazardous waste facilities. CERCLA section 103(a) requires the owner or operator of a vessel or onshore or offshore facility to notify the National Response Center (NRC) of any spill or other release of a hazardous substance that equals or exceeds a reportable quantity (RQ), as defined by CERCLA section 101. Additionally, CERCLA section 103(c) requires facilities that have “stored, treated, or disposed of” hazardous wastes and where there is “known, suspected, or likely releases” of hazardous substances to report their activities to EPA.

CERCLA section 120(d) requires EPA to take steps to assure that a Preliminary Assessment (PA) be completed for those sites identified in the Docket and that the evaluation and listing of sites with a PA be completed within a reasonable time frame. The PA is designed to provide information for EPA to consider when evaluating the site for potential response action or inclusion on the National Priorities List (NPL).

The Docket serves three major purposes: (1) To identify all Federal facilities that must be evaluated to determine whether they pose a threat to human health and the environment sufficient to warrant inclusion on the National Priorities List (NPL); (2) to compile and maintain the information submitted to EPA on such facilities under the provisions listed in section 120(c) of CERCLA; and (3) to provide a mechanism to make the information available to the public. Previous Docket updates are available at https://www.epa.gov/fedfac/previous-federal-agency-hazardous-waste-compliance-docket-updates.

This notice provides some background information on the Docket. Additional information on the Docket requirements and implementation are found in the Docket Reference Manual, Federal Agency Hazardous Waste Compliance Docket found at http://www.epa.gov/fedfac/docket-reference-manual-federal-agency-hazardous-waste-compliance-docket-interim-final or obtained by calling the Regional Docket Coordinators listed below. This notice also provides changes to the list of sites included on the Docket in three areas: (1) Additions, (2) Deletions, and (3) Corrections. Specifically, additions are newly identified Federal facilities that have been reported to EPA since the last update and now are included on the Docket; the deletions section lists Federal facilities that EPA is deleting from the Docket. 1 The information submitted to EPA on each Federal facility is maintained in the Docket repository located in the EPA Regional office of the Region in which the Federal facility is located; for a description of the information required under those provisions, see 53 FR 4280 (February 12, 1988). Each repository contains the documents submitted to EPA under the reporting provisions and correspondence relevant to the reporting provisions for each Federal facility.

In prior updates, information was also provided regarding No Further Remedial Action Planned (NFRAP) status changes. However, information on NFRAP and NPL status is no longer being provided separately in the Docket update as it is now available at: http://www.epa.gov/fedfac/fedfacts or by contacting the EPA HQ Docket Coordinator at the address provided in the FOR FURTHER INFORMATION CONTACT section of this notice.

Contact the following Docket Coordinators for information on Regional Docket repositories:

• U.S. EPA Region 1. Martha Bosworth (HBS), 5 Post Office Square, Suite 100, Mail Code: OSRR07-2, Boston, MA 02109-3912, (617) 918-1407.

• U.S. EPA Region 2. Cathy Moyik (ERRD), 290 Broadway, New York, NY 10007-1866, (212) 637-4339.

• U.S. EPA Region 3. Joseph Vitello (3HS12), 1650 Arch Street, Philadelphia, PA 19107, (215) 814-3354.

• U.S. EPA Region 3. Dawn Fulsher (3HS12), 1650 Arch Street, Philadelphia, PA 19107, (215) 814-3270.

• U.S. EPA Region 4. Alayna Famble (9T25), 61 Forsyth St. SW, Atlanta, GA 30303, (404) 564-8444.

• U.S. EPA Region 5. David Brauner (SR-6J), 77 W Jackson Blvd., Chicago, IL 60604, (312) 886-1526.

• U.S. EPA Region 6. Philip Ofosu (6SF-RA), 1445 Ross Avenue, Dallas, TX 75202-2733, (214) 665-3178.

• U.S. EPA Region 7. Todd H. Davis (SUPRERSP), 11201 Renner Blvd., Lenexa, KS 66219, (913) 551-7749.

• U.S. EPA Region 8. Ryan Dunham (EPR-F), 1595 Wynkoop Street, Denver, CO 80202, (303) 312-6627.

• U.S. EPA Region 9. Leslie Ramirez (SFD-6-1), 75 Hawthorne Street, San Francisco, CA 94105, (415) 972-3978.

• U.S. EPA Region 10. Ken Marcy, Oregon Operations Office, 805 SW Broadway, Suite 500, Portland, OR 97205, (503) 326-3269.

This section includes a discussion of the additions, deletions and corrections to the list of Docket facilities since the previous Docket update.

These Federal facilities are being added primarily because of new information obtained by EPA (for example, recent reporting of a facility pursuant to RCRA sections 3005, 3010, or 3016 or CERCLA section 103). CERCLA section 120, as amended by the Defense Authorization Act of 1997, specifies that EPA take steps to assure that a Preliminary Assessment (PA) be completed within a reasonable time frame for those Federal facilities that are included on the Docket. Among other things, the PA is designed to provide information for EPA to consider when evaluating the site for potential response action or listing on the NPL. This notice includes two additions.

There are no statutory or regulatory provisions that address deletion of a facility from the Docket. However, if a facility is incorrectly included on the Docket, it may be deleted from the Docket. The criteria EPA uses in deleting sites from the Docket include: A facility for which there was an incorrect report submitted for hazardous waste activity under RCRA ( e.g., 40 CFR 262.44); a facility that was not Federally-owned or operated at the time of the listing; a facility included more than once ( i.e., redundant listings); or when multiple facilities are combined under one listing. ( See Docket Codes ( Reasons for Deletion of Facilities ) for a more refined list of the criteria EPA uses for deleting sites from the Docket.) Facilities being deleted no longer will be subject to the requirements of CERCLA section 120(d). This notice includes zero deletions.

Changes necessary to correct the previous Docket are identified by both EPA and Federal agencies. The corrections section may include changes in addresses or spelling, and corrections of the recorded name and ownership of a Federal facility. In addition, changes in the names of Federal facilities may be made to establish consistency in the Docket or between the Superfund Enterprise Management System (SEMS) and the Docket. For the Federal facility for which a correction is entered, the original entry is as it appeared in previous Docket updates. The corrected update is shown directly below, for easy comparison. This notice includes zero corrections.

In compiling the newly reported Federal facilities for the update being published in this notice, EPA extracted the names, addresses, and identification numbers of facilities from four EPA databases—the WebEOC, the Biennial Inventory of Federal Agency Hazardous Waste Activities, the Resource Conservation and Recovery Act Information System (RCRAInfo), and SEMS—that contain information about Federal facilities submitted under the four provisions listed in CERCLA section 120(c).

EPA assures the quality of the information on the Docket by conducting extensive evaluation of the current Docket list and contacts the other Federal Agency (OFA) with the information obtained from the databases identified above to determine which Federal facilities were, in fact, newly reported and qualified for inclusion on the update. EPA is also striving to correct errors for Federal facilities that were previously reported. For example, state-owned or privately-owned facilities that are not operated by the Federal government may have been included. Such problems are sometimes caused by procedures historically used to report and track Federal facilities data. Representatives of Federal agencies are asked to contact the EPA HQ Docket Coordinator at the address provided in the FOR FURTHER INFORMATION CONTACT section of this notice if revisions of this update information are necessary.

Certain categories of facilities may not be included on the Docket, such as: (1) Federal facilities formerly owned by a Federal agency that at the time of consideration was not Federally-owned or operated; (2) Federal facilities that are small quantity generators (SQGs) that have not, more than once per calendar year, generated more than 1,000 kg of hazardous waste in any single month; (3) Federal facilities that are very small quantity generators (VSQGs) that have never generated more than 100 kg of hazardous waste in any month; (4) Federal facilities that are solely hazardous waste transportation facilities, as reported under RCRA section 3010; and (5) Federal facilities that have mixed mine or mill site ownership.

An EPA policy issued in June 2003 provided guidance for a site-by-site evaluation as to whether “mixed ownership” mine or mill sites, typically created as a result of activities conducted pursuant to the General Mining Law of 1872 and never reported under section 103(a) of CERCLA, should be included on the Docket. For purposes of that policy, mixed ownership mine or mill sites are those located partially on private land and partially on public land. This policy is found at http://www.epa.gov/fedfac/policy-listing-mixed-ownership-mine-or-mill-sites-created-result-general-mining-law-1872. The policy of not including these facilities may change; facilities now omitted may be added at some point if EPA determines that they should be included.

EPA tracks the NPL status of Federal facilities listed on the Docket. An updated list of the NPL status of all Docket facilities, as well as their NFRAP status, is available at http://www.epa.gov/fedfac/fedfacts or by contacting the EPA HQ Docket Coordinator at the address provided in the FOR FURTHER INFORMATION CONTACT section of this notice. In prior updates, information regarding NFRAP status changes was provided separately.

The information is provided in three tables. The first table is a list of additional Federal facilities that are being added to the Docket. The second table is a list of Federal facilities that are being deleted from the Docket. The third table is for corrections.

The Federal facilities listed in each table are organized by the date reported. Under each heading is listed the name and address of the facility, the Federal agency responsible for the facility, the statutory provision(s) under which the facility was reported to EPA, and a code. 2

The statutory provisions under which a Federal facility is reported are listed in a column titled “Reporting Mechanism.” Applicable mechanisms are listed for each Federal facility: For example, Sections 3005, 3010, 3016, 103(c), or Other. “Other” has been added as a reporting mechanism to indicate those Federal facilities that otherwise have been identified to have releases or threat of releases of hazardous substances. The National Contingency Plan at 40 CFR 300.405 addresses discovery or notification, outlines what constitutes discovery of a hazardous substance release, and states that a release may be discovered in several ways, including: (1) A report submitted in accordance with section 103(a) of CERCLA, i.e., reportable quantities codified at 40 CFR 302; (2) a report submitted to EPA in accordance with section 103(c) of CERCLA; (3) investigation by government authorities conducted in accordance with section 104(e) of CERCLA or other statutory authority; (4) notification of a release by a Federal or state permit holder when required by its permit; (5) inventory or survey efforts or random or incidental observation reported by government agencies or the public; (6) submission of a citizen petition to EPA or the appropriate Federal facility requesting a preliminary assessment, in accordance with section 105(d) of CERCLA; (7) a report submitted in accordance with section 311(b)(5) of the Clean Water Act; and (8) other sources. As a policy matter, EPA generally believes it is appropriate for Federal facilities identified through the CERCLA discovery and notification process to be included on the Docket.

The complete list of Federal facilities that now make up the Docket and the NPL and NFRAP status are available to interested parties and can be obtained at http://www.epa.gov/fedfac/fedfacts or by contacting the EPA HQ Docket Coordinator at the address provided in the FOR FURTHER INFORMATION CONTACT section of this notice. As of the date of this notice, the total number of Federal facilities that appear on the Docket is 2,382.

• Code 1. Small-Quantity Generator and Very Small Quantity Generator. Show citation box

• Code 2. Never Federally Owned and/or Operated.

• Code 3. Formerly Federally Owned and/or Operated but not at time of listing.

• Code 4. No Hazardous Waste Generated.

• Code 5. (This code is no longer used.)

• Code 6. Redundant Listing/Site on Facility.

• Code 7. Combining Sites Into One Facility/Entries Combined.

• Code 8. Does Not Fit Facility Definition.

• Code 15. Small-Quantity Generator with either a RCRA 3016 or CERCLA 103 Reporting Mechanism.

• Code 16. One Entry Being Split Into Two (or more)/Federal Agency Responsibility Being Split.

• Code 16A. NPL site that is part of a Facility already listed on the Docket.

• Code 17. New Information Obtained Showing That Facility Should Be Included.

• Code 18. Facility Was a Site on a Facility That Was Disbanded; Now a Separate Facility.

• Code 19. Sites Were Combined Into One Facility.

• Code 19A. New Currently Federally Owned and/or Operated Facility Site.

• Code 20. Reporting Provisions Change.

• Code 20A. Typo Correction/Name Change/Address Change.

• Code 21. Changing Responsible Federal Agency. (If applicable, new responsible Federal agency submits proof of previously performed PA, which is subject to approval by EPA.)

• Code 22. Changing Responsible Federal Agency and Facility Name. (If applicable, new responsible Federal Agency submits proof of previously performed PA, which is subject to approval by EPA.)

• Code 24. Reporting Mechanism Determined To Be Not Applicable After Review of Regional Files.

OMB Control Number: 3060-0519.

Title: Rules and Regulations Implementing the Telephone Consumer Protection Act (TCPA) of 1991, CG Docket No. 02-278.

Form Number: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit entities; Individuals or households; Not-for-profit institutions.

Number of Respondents and Responses: 169,369 respondents; 191,628,905 responses.

Estimated Time per Response: .004 hours (15 seconds) to 1 hour.

Frequency of Response: Annual, monthly, on occasion and one-time reporting requirements; Recordkeeping requirement; Third party disclosure requirement.

Obligation to Respond: Required to obtain or retain benefits. The statutory authority for the information collection requirements are found in the Telephone Consumer Protection Act of 1991 (TCPA), Public Law 102-243, December 20, 1991, 105 Stat. 2394, which added Section 227 of the Communications Act of 1934, [47 U.S.C. 227] Restrictions on the Use of Telephone Equipment.

Total Annual Burden: 3,251,008 hours. Total Annual Cost: $1,357,200.

Nature and Extent of Confidentiality: Confidentiality is an issue to the extent that individuals and households provide personally identifiable information, which is covered under the FCC's system of records notice (SORN), FCC/CGB-1, “Informal Complaints and Inquiries.” As required by the Privacy Act, 5 U.S.C. 552a, the Commission also published a SORN, FCC/CGB-1 “Informal Complaints, Inquiries, and Requests for Dispute Assistance”, in the Federal Register on August 15, 2014 (79 FR 48152) which became effective on September 24, 2014. A system of records for the do-not-call registry was created by the Federal Trade Commission (FTC) under the Privacy Act. The FTC originally published a notice in the Federal Register describing the system. See 68 FR 37494, June 24, 2003. The FTC updated its system of records for the do-not-call registry in 2009. See 74 FR 17863, April 17, 2009.

Privacy Impact Assessment: Yes.

Needs and Uses: The reporting requirements included under this OMB Control Number 3060-0519 enable the Commission to gather information regarding violations of section 227 of the Communications Act, the Do-Not-Call Implementation Act (Do-Not-Call Act), and the Commission's implementing rules. If the information collection was not conducted, the Commission would be unable to track and enforce violations of section 227 of the Communications Act, the Do-Not-Call Act, or the Commission's implementing rules. The Commission's implementing rules provide consumers with several options for avoiding most unwanted telephone solicitations.

The national do-not-call registry supplements the company-specific do-not-call rules for those consumers who wish to continue requesting that particular companies not call them. Any company that is asked by a consumer, including an existing customer, not to call again must honor that request for five (5) years. A provision of the Commission's rules, however, allows consumers to give specific companies permission to call them through an express written agreement. Nonprofit organizations, companies with whom consumers have an established business relationship, and calls to persons with whom the telemarketer has a personal relationship are exempt from the “do-not-call” registry requirements.

On September 21, 2004, the Commission released the Safe Harbor Order, published at 69 FR 60311, October 8, 2004, establishing a limited safe harbor in which persons will not be liable for placing autodialed and prerecorded message calls to numbers ported from a wireline service within the previous 15 days. The Commission also amended its existing National Do-Not-Call Registry safe harbor to require telemarketers to scrub their lists against the Registry every 31 days.

On December 4, 2007, the Commission released the DNC NPRM, published at 72 FR 71099, December 14, 2007, seeking comment on its tentative conclusion that registrations with the Registry should be honored indefinitely, unless a number is disconnected or reassigned or the consumer cancels his registration.

On June 17, 2008, in accordance with the Do-Not-Call Improvement Act of 2007, the Commission revised its rules to minimize the inconvenience to consumers of having to re-register their preferences not to receive telemarketing calls and to further the underlying goal of the National Do-Not-Call Registry to protect consumer privacy rights. The Commission released a Report and Order in CG Docket No. 02-278, FCC 08-147, published at 73 FR 40183, July 14, 2008, amending the Commission's rules under the Telephone Consumer Protection Act (TCPA) to require sellers and/or telemarketers to honor registrations with the National Do-Not-Call Registry so that registrations will not automatically expire based on the current five-year registration period. Specifically, the Commission modified § 64.1200(c)(2) of its rules to require sellers and/or telemarketers to honor numbers registered on the Registry indefinitely or until the number is removed by the database administrator or the registration is cancelled by the consumer.

On February 15, 2012, the Commission released a Report and Order in CG Docket No. 02-278, FCC 12-21, originally published at 77 FR 34233, June 11, 2012, and later corrected at 77 FR 66935, November 8, 2012, revising its rules to: (1) Require prior express written consent for all autodialed or prerecorded telemarketing calls to wireless numbers and for all prerecorded telemarketing calls to residential lines; (2) eliminate the established business relationship exception to the consent requirement for prerecorded telemarketing calls to residential lines; (3) require telemarketers to include an automated, interactive opt-out mechanism in all prerecorded telemarketing calls, to allow consumers more easily to opt out of future robocalls during a robocall itself; and (4) require telemarketers to comply with the 3% limit on abandoned calls during each calling campaign, in order to discourage intrusive calling campaigns.

Finally, the Commission also exempted from the Telephone Consumer Protection Act requirements prerecorded calls to residential lines made by health care-related entities governed by the Health Insurance Portability and Accountability Act of 1996.

OMB Control Number: 3060-0952.

Title: Proposed Demographic Information and Notifications, Second Further Notice of Proposed Rulemaking (FNPRM), CC Docket No. 98-147 and Fifth NPRM (NPRM), CC Docket No. 96- 98.

Form Number: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit entities.

Number of Respondents and Responses: 750 respondents; 1,500 responses.

Frequency of Response: On occasion reporting requirements and third party disclosure requirement.

Estimated Time per Response: 2 hours.

Total Annual Burden: 3,000 hours.

Total Annual Cost: No cost.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 151-154, 201, 202, 251-254, 256 and 271 of the Communications Act of 1934, as amended.

Privacy Act Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: The Commission is not requesting respondents to submit confidential information to the FCC. If the applicants wish to submit information which they believe is confidential, they may request confidential treatment of such information under 47 CFR 0.459 of the Commission's rules.

Needs and Uses: The Commission asked whether physical collocation in remote terminals presents technical or security concerns, and if so, whether these concerns warrant modification of its collocation rules. The Commission asked whether incumbent LECs should be required to provide requesting carriers with demographic and other information regarding particular remote terminals similar to the information available regarding incumbent LEC central offices. Requesting carriers use demographic and other information obtained from incumbent LECs to determine whether they wish to collocate at particular remote terminals. This proposed information collection in the Second Further Notice of Proposed Rulemaking, FCC 98-147, will be used by the Commission, state commissions, and competitive carriers to facilitate the deployment of advanced services and other telecommunications services in implementation of section 251(c)(6) of the Communications Act of 1934, as amended. The number of respondents, annual responses, and annual burden hours have not changed.

The Commission may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

As part of its continuing effort to reduce paperwork burdens, as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the FCC invited the general public and other Federal Agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimates; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology. Pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4), the FCC seeks specific comment on how it might “further reduce the information collection burden for small business concerns with fewer than 25 employees.”

OMB Control Number: 3060-XXXX.

Title: FCC Authorization for Radio Service Authorization; Wireless Telecommunications Bureau; Public Safety and Homeland Security Bureau, FCC Form 601-2.0.

Form Number: FCC Form 601-2.0.

Type of Review: New collection.

Respondents: Individual and households, Business or other for-profit entities, state, local, or tribal government, and not for profit institutions.

Number of Respondents: 24 respondents; 176 responses.

Estimated Time per Response: 0.5 hours.

Frequency of Response: Recordkeeping requirement; third party disclosure requirement, on occasion reporting requirement and periodic reporting requirement.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for these collections are contained in 47 U.S.C. 151, 152, 155(c), 158, 201, 202, 208, 214, 301, 302a, 303, 307, 308, 309, 310, 311, 314, 316, 319, 324, 332, and 333 of the Communications Act of 1934.

Total Annual Burden: 88 hours.

Total Annual Cost: $18,150.

Privacy Impact Assessment: Yes.

Nature and Extent of Confidentiality: In general, there is no need for confidentiality with this collection of information.

Needs and Uses: The Commission is submitting a request to the Office of Budget and Management (OMB) for approval of the FCC Form 601-2.0, a new data collection that will gradually replace the FCC Form 601 (3060-0798). The Commission is implementing a new electronic licensing system called Universal Licensing System 2.0 (ULS 2.0) to replace the current Universal Licensing System (ULS). Services will gradually be moved to the new ULS 2.0, beginning with market-based Special Temporary Authority (STA) applications.

The burden hours and costs associated with market-based STAs will now be a part of the ULS 2.0 system and FCC Form 601-2.0. The FCC Form 601-2.0 will be a consolidated electronic data collection for market-based and site-based licensing for wireless telecommunications services, including public safety, which will be filed through the Commission's modernized Universal Licensing System 2.0 (ULS-2.0).

This form will gradually replace the FCC Form 601 (3060-0798) as services are moved from legacy ULS to ULS 2.0. The substance of and wording of the FCC Form 601 data collection will remain the same in the new system. The data collected in ULS 2.0 consists of administrative, technical, and other information needed for licensing if wireless radio services. Once fully implemented, this system will be used to submit all Wireless Services applications along with any supporting documentation. The application purposes include: Applying for a new license (including STA's) modifying or renewing an existing license, cancelling a license, submitting required notifications, requesting an extension of time to satisfy construction requirements, and requesting an administrative update to an existing license (such as mailing address change). Applicants can also amend or withdraw applications while they are pending in ULS.2.0. The data collected in ULS 2.0 includes the FCC Registration Number (FRN), which serves as a “common link” for all filings an entity has with the FCC. The Debt Collection Improvement Act of 1996 requires entities filing with the Commission to use an FRN. ULS 2.0 data records may include information about individuals or households, e.g., personally identifiable information or PII, and the use(s) and disclosure of this information are governed by the requirements of a system of records notice or “SORN”, FCC/WTB-1, “Wireless Services Licensing Records.” There are no additional impacts under the Privacy Act.

OMB Control Number: 3060-XXXX.

Title: Legacy Support Usage Flexibility Certification.

Form Number: N/A.

Type of Review: New information collection.

Respondents: Business or other for-profit entities, not-for-profit institutions, and state, local or tribal governments.

Number of Respondents and Responses: Up to 110 respondents and 110 responses.

Estimated Time per Response: 1.75 hours.

Frequency of Response: One-time reporting requirement.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 154, 254 and 303(r).

Total Annual Burden: 193 hours.

Total Annual Cost: $16,500.

Nature and Extent of Confidentiality: The information collected under this collection will be made publicly available. However, to the extent that a respondent seeks to have certain information collected in response to this information collection withheld from public inspection, the respondent may request confidential treatment pursuant to 47 CFR 0.459 of the Commission's rules, 47 CFR Section 0.459.

Privacy Act Impact Assessment: No impact(s).

Needs and Uses: A request for approval of this new information collection will be submitted to the Office of Management and Budget (OMB) after this 60-day comment period in order to obtain the full three-year clearance from OMB.

On November 18, 2011, the Commission released the USF/ICC Transformation Order (FCC 11-161) in which it comprehensively reformed and modernized the universal service and intercarrier compensation systems to ensure that robust, affordable voice and broadband service, both fixed and mobile, are available to Americans throughout the nation. In the USF/ICC Transformation Order, the Commission, among other things, adopted a requirement that all ETCs offer broadband service in their supported area that meets certain basic performance requirements and report regularly on associated performance measures as a condition of receiving federal high-cost universal service support.

On October 27, 2020, the Commission adopted the 5G Fund Report and Order (FCC 20-150) in which it, among other things, helped to complete the reform of the high-cost program begun in the USF/ICC Transformation Order by adopting additional public interest obligations and performance requirements for legacy high-cost support recipients, whose broadband-specific public interest obligations for mobile wireless services were not previously detailed.

The public interest obligations adopted in the 5G Fund Report and Order for each competitive eligible telecommunications carrier (ETC) receiving legacy high-cost support for mobile wireless services require that such a carrier (1) use an increasing percentage of its legacy support toward the deployment, maintenance, and operation of voice and broadband networks that support 5G meeting the adopted performance requirements within its subsidized service area(s), and (2) meet specific 5G broadband service deployment coverage requirements and service deployment milestone deadlines that take into consideration the amount of legacy support the carrier receives. With respect to the requirement to use an increasing percentage of its legacy support toward the deployment, maintenance, and operation of voice and broadband networks that support5G, the rules adopted in the 5G Fund Report and Order specify that each legacy support recipient must use at least one-third of the legacy support it receives in 2021, at least two-thirds of the legacy support it receives in 2022, and all of the legacy support in 2023 and beyond for these purposes.

To address a concern that budgets and deployment plans for 2021 are largely complete, which could make it difficult for some competitive ETCs to achieve the 2021 support usage requirement, the Commission adopted a rule that affords such competitive ETCs the flexibility to use less than one-third of their legacy support in 2021 and make up for any shortfall in 2021 by proportionally increasing the requirement in 2022 (above the two-thirds of its support the competitive ETC is required to spend on 5G in that year). See 47 CFR 54.322(c)(4).

In order to take advantage of this flexibility, a competitive ETC receiving legacy support for mobile wireless services must submit a certification in which it (1) provides information regarding the service area(s) for which it and any affiliated mobile competitive ETC(s) receive legacy supportand the annual amount of support they receive in each area; (2) indicates the total amount of legacy high-cost support to be spent on the deployment, maintenance, and operation of mobile networks that provide 5G service in calendar year 2021 across the identified service areas; and (3) certifies that any 2021 spending shortfall will be made up in 2022. Only those competitive ETCs receiving legacy high-cost support for mobile wireless services that wish to avail themselves of the flexibility concerning their 2021 and 2022 legacy high-cost support usage requirements will be required to respond to this information collection.

The certification will be used by the Commission to identify how much a competitive ETC that chooses to avail itself of the flexibility concerning its 2021 and 2022 legacy high-cost support usage requirements will spend on 5G in 2021 and the spending shortfall it must make up in 2022, and to confirm the competitive ETC's commitment to make up its 2021 spending shortfall in 2022 in accordance with its certification and the Commission's rules.

Request for Comments

The Commission, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on the continuing information collection listed in this notice, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

Comments submitted in response to this notice will be included or summarized in our request for Office of Management and Budget (OMB) approval of the relevant information collection. All comments are part of the public record and subject to disclosure. Please do not include any confidential or inappropriate material in your comments. We invite comments on: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

Title: 46 CFR part 565—Controlled Carriers.

OMB Approval Number: 3072-0060 (Expires September 30, 2021).

Abstract: 46 U.S.C. 40701-40706 requires that the Commission monitor the practices of controlled carriers to ensure that they do not maintain rates or charges in their tariffs and service contracts that are below a level that is just and reasonable; nor establish, maintain, or enforce unjust or unreasonable classifications, rules, or regulations in those tariffs or service contracts that result or are likely to result in the carriage or handling of cargo at rates or charges that are below a just and reasonable level. 46 CFR part 565 establishes the method by which the Commission determines whether a particular ocean common carrier is a controlled carrier subject to 46 U.S.C. 40701-40706. When a government acquires a controlling interest in an ocean common carrier, or when a controlled carrier newly enters a United States trade, the Commission's rules require that such a carrier notify the Commission of these events.

Current Actions: There are no changes to this information collection, and it is being submitted for extension purposes only.

Type of Review: Extension.

Needs and Uses: The Commission uses these notifications in order to effectively discharge its statutory duty to determine whether a particular ocean common carrier is a controlled carrier and therefore subject to the requirements of 46 U.S.C. 40701-40706.

Frequency: The submission of notifications from controlled carriers is not assigned to a specific time frame by the Commission; they are submitted as circumstances warrant. The Commission only requires notification when a majority portion of an ocean common carrier becomes owned or controlled by a government, or when a controlled carrier newly begins operation in any United States trade.

Type of Respondents: Controlled carriers are ocean common carriers which are owned or controlled by a government.

Number of Annual Respondents: The Commission cannot anticipate when a new controlled carrier may enter the United States trade or when ownership or control of a carrier will change so that notification is required. Over the past three years, the Commission has received, on average, fewer than one notification per year.

Estimated Time per Response: The estimated time for each notification is 2 hours

Total Annual Burden: For purposes of calculating total annual burden, the Commission assumes one response annually. The Commission thus estimates the total annual burden to be 2 hours (1 response × 2 hours per response).

Description: Through the VIQI Project, OPRE aims to inform policymakers, practitioners, and stakeholders about effective ways to support the quality and effectiveness of early care and education (ECE) centers for promoting young children's learning and development. The VIQI Project completed a pilot study in about 40 centers in three metropolitan areas in 2018-2019 that is informing a year-long impact evaluation and process study that involves testing the effectiveness of two curricular and professional development models aiming to strengthen the quality of classroom processes and children's outcomes. The impact evaluation and process study is expected to begin in the fall of 2021 and will include about 140 community-based and Head Start ECE centers spread across about 12 different metropolitan areas in the United States.

The VIQI Project will consist of a 3-group experimental design where the initial quality and other characteristics of ECE centers are measured. For details about the study design, see the Supporting Statements at https://www.reginfo.gov/public/do/PRAViewDocument?ref_nbr=202008-0970-009.

In anticipation of changes to center characteristics due to COVID-19, annual burden estimates and instruments have been updated to accommodate a different sample size of centers, administrators, teachers, and coaches for the impact evaluation and process study.

The previously approved data collection instruments for the impact evaluation and process study include the following:

(1) Instruments for Screening and Recruitment of ECE Centers. We do not propose any changes to these materials;

(2) Baseline Instruments. Modifications made to surveys remove items that showed little variation in the pilot study, edit item wording to increase clarity and ease of understanding, and add a few new items to capture new constructs of interest based upon the insights gained from the pilot study. The child assessment and classroom observation instruments have been updated to reflect the selected assessments and observations. We added an additional time point of data collection (baseline) for teacher reports on questions about children in the classroom and have added in questions about children's academic skills. Parent/guardian reports to questions about children in the classroom have been added to gather information about children's skills at the beginning of the impact evaluation and process study. Administrator/teacher COVID-19 supplemental survey questions have been added to gather information about how the pandemic has changed typical center and classroom programming and functioning, if there is a need to contextualize findings from the impact evaluation and process study due to circumstances surrounding the COVID-19 pandemic at the time of data collection;

(3) Follow-Up Instruments. Modifications made to surveys remove items that showed little variation in the pilot study, edit item wording to increase clarity and ease of understanding, and add a few new items to capture new constructs of interest based upon insights gained from the pilot study. The child assessment and classroom observation instruments have been updated to reflect the selected assessments and observations. We added in questions about children's academic skills to the teacher reports on questions about children in the classroom. Parent/guardian reports to questions about children have been added to gather information about children's skills at the end of the impact evaluation and process study; and

(4) Fidelity of Implementation Instruments. Modifications to the Coach Log have been made to remove or consolidate items that showed little variation or proved less useful in the pilot study and to edit item wording to increase clarity and ease of understanding.

Respondents: Staff members working in Head Start grantee and community-based child care oversight agencies, staff members working in about 140 ECE centers in about 12 metropolitan areas across the United States, and parents and children being served in these centers.

Estimated Total Annual Burden Hours: 7,850.

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.

Form FDA 3913, User Fee Payment Refund Request, is designed to provide the minimum necessary information for FDA to review and process a user fee payment refund. The information collected includes the organization, contact, and payment information. The information is used to determine the reason for the refund, the refund amount, and who to contact if there are any questions regarding the refund request. A submission of the User Fee Payment Refund Request form does not guarantee that a refund will be issued. FDA estimates an average of 0.40 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed, and complete and review the collection of information. The estimated hours are based on past FDA experience with the user fee payment refund request.

In fiscal year 2020, approximately 474 user fee refunds were processed for cover sheets and invoices including 0 for Animal Drug User Fees, 0 for Animal Generic Drug User Fees, 1 for Biosimilar Drug User Fees, 0 for Export Certificate Program fees, 0 for Freedom of Information Act requests, 31 for Generic Drug User Fees, 200 for Medical Device User Fees, 240 for Medical Device Federal Unified Registration and Listing fees, 0 for Mammography inspection fees, 1 for Prescription Drug User Fees, and 0 for Tobacco product fees.

Form FDA 3914, User Fee Payment Transfer Request, is designed to provide the minimum necessary information for FDA to review and process a user fee payment transfer request. The information collected includes payment and organization information. The information is used to determine the reason for the transfer, how the transfer should be performed, and who to contact if there are any questions regarding the transfer request. A submission of the User Fee Payment Transfer Request form does not guarantee that a transfer will be performed. FDA estimates an average of 0.25 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed, and complete and review the collection of information. FDA estimated hours are based on past FDA experience with the user fee payment transfer requests.

In fiscal year 2020, approximately 194 user fee payment transfers were processed for cover sheets and invoices including 0 for Animal Drug User Fees, 0 for Animal Generic Drug User Fees, 1 for Biosimilar Drug User Fees, 34 for Generic Drug User Fees, 78 for Medical Device User Fees, 80 for Medical Device Federal Unified Registration and Listing fees, 0 for Mammography inspection fees, 1 for Prescription Drug User Fees, and 0 for Tobacco product fees.

Respondents for the electronic request forms include domestic and foreign firms (including pharmaceutical, biological, medical device firms, etc.). Specifically, refund request forms target respondents who submitted a duplicate payment or overpayment for a user fee cover sheet or invoice. Respondents may also include firms that withdrew an application or submission. Transfer request forms target respondents who submitted payment for a user fee cover sheet or invoice and need that payment to be re-applied to another cover sheet or invoice (transfer of funds).

The electronic user fee payment request forms streamline the refund and transfer processes, facilitate processing, and improve the tracking of refund or transfer requests. The burden for this collection of information is the same for all customers (small and large organizations). The information being requested or required has been held to the absolute minimum required for the intended use of the data. Respondents are able to request a user fee payment refund or transfer online at https://www.fda.gov/forindustry/userfees/default.htm. This electronic submission is intended to reduce the burden for customers to submit a user fee payment refund and transfer request.

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

The current burden estimate shows a decrease of approximately 642 hours for this information collection over that reported previously. The change reflects increased experience by the respondents to correctly submit fee payments, and increased sophistication in use of the forms to request payments made in error. The use of the forms for the user fee programs ( e.g., Prescription Drug User Fees, Generic Drug User Fees, Animal Drug User Fees, Animal Generic Drug User Fees, Biosimilar Drug User Fees) are optional.

In addition, new information technology applications have more accurately calculated the number of registrants of drug facilities/food facilities/medical device facilities/medicated feed facilities, and we have therefore revised the number of respondents to the information collection.

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 FDA regulations and FDA's Medical Device Reporting program. Section 519(a), (b), and (c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360i(a), (b), and (c)) requires user facilities, manufacturers, importers, and distributors of medical devices to report adverse events involving medical devices to FDA. These provisions are codified in part 803 (21 CFR part 803), Medical Device Reporting. As amended most recently by the FDA Reauthorization Act of 2017 (FDARA) (Pub. L. 115-52), medical device manufacturers and importers must submit medical device reports (MDRs) using FDA's electronic submission system. User facilities, however, may elect to submit reports using paper-based Form FDA 3500A—MedWatch—Mandatory Reporting (approved under OMB control number 0910-0291). The regulations also establish recordkeeping requirements and provide for certain exemptions, variances, or alternative forms of reporting. Exemptions and/or variances from individual reporting must be requested in writing and must receive Agency approval. Additionally, the regulations permit user facilities to submit paper-based annual reports, for which we have developed Form FDA 3419 entitled “Medical Device Reporting Annual User Facility Report.”

This information collection also includes the use of existing formats such as Form FDA 3500A  1 —MedWatch—Mandatory Reporting to allow manufacturers to summarize in a single report multiple events with shared characteristics for device associated reportable malfunction events. For example, the Voluntary Malfunction Summary Reporting Program (VMSRP)  2 provides recommendations for manufacturers of certain devices to submit a single report that summarizes multiple device associated reportable malfunction events on a quarterly basis. The VMSRP was established under section 519(a)(1)(B)(ii) of the FD&C Act and reflects goals for streamlining malfunction reporting as outlined in the Medical Device User Fee Amendments (MDUFA) IV “Commitment Letter” for 2018 through 2022 agreed to by FDA and industry and submitted to Congress. The Commitment Letter was finalized with the passage of FDARA on August 18, 2017, and, as passed, is entitled “MDUFA Performance Goals And Procedures, Fiscal Years 2018 Through 2022.”  3

The information that is obtained from this information collection will be used to evaluate risks associated with medical devices and enable FDA to take appropriate measures to protect the public health. Complete, accurate, and timely adverse event information is necessary for the identification of emerging device problems so the Agency can protect the public health under section 519 of the FD&C Act. FDA makes the releasable information available to the public for downloading on its website. Respondents are manufacturers and importers of medical devices and device user facilities. 4

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 additional 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 additional 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 implementation of sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353a and 21 U.S.C. 353b), which govern compounding by pharmacies, outsourcing facilities, and other entities. Compounding is generally a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient. Although compounded drugs can serve an important medical need for certain patients, they also present risks to patients. Our compounding program aims to protect patients from unsafe, ineffective, and poor quality compounded drugs, while preserving access to lawfully-marketed compounded drugs for patients who have a medical need for them. Respondents to the information collection are pharmacies, outsourcing facilities, and other entities.

To assist respondents in complying with statutory requirements, we have issued the following topic-specific guidance documents:

These guidance documents were issued consistent with our Good Guidance Practice regulations in 21 CFR part 10.115 which provide for public comment at any time. The guidance documents communicate our current thinking on the respective topics and include information collection that may result in expenditures of time and effort by respondents. In our notices of availability we also solicited public comment under the PRA on the information collection provisions. FDA has developed and maintains a searchable guidance database available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Guidance documents covered by this information collection may be found by choosing “Center for Drug Evaluation and Research” from among the FDA Organizations, and by selecting the term “Compounding” from among the possible Filters. 1 For efficiency of operations we are consolidating the related information collections.

Because Congress explicitly excluded radiopharmaceuticals from section 503A of the FD&C Act (see section 503A(d)(2)), compounded radiopharmaceuticals are not eligible for the exemptions under section 503A from section 505 of the FD&C Act (21 U.S.C. 355) (concerning new drug approval requirements), section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) (concerning labeling with adequate directions for use), and section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)B)) (concerning current good manufacturing practice (CGMP) requirements). In addition, the FD&C Act does not provide an exemption for repackaged radiopharmaceuticals. This guidance document describes the conditions under which FDA does not intend to take action for violations of sections 505, 502(f)(1), and 501(a)(2)(B) of the FD&C Act when a state-licensed nuclear pharmacy, Federal facility, or other facility that is not an outsourcing facility and that holds a radioactive materials license for medical use issued by the Nuclear Regulatory Commission or by an Agreement State compounds or repackages radiopharmaceuticals for human use. The guidance explains that one condition is that the compounded radiopharmaceutical is not essentially a copy of an approved radiopharmaceutical. As described in the guidance, FDA does not intend to consider a compounded radiopharmaceutical to be essentially a copy if, among other reasons, there is a change between the compounded radiopharmaceutical and the approved radiopharmaceutical that produces a clinical difference for an identified individual patient, as determined by the prescribing practitioner and documented in writing on the prescription or order. In addition, FDA does not intend to consider a compounded radiopharmaceutical to be essentially a copy if the FDA-approved radiopharmaceutical is on FDA's drug shortage list (see section 506E of the FD&C Act (21 U.S.C. 356e)) at the time of compounding and distribution. If the facility compounded a drug that is identical or nearly identical to an approved drug product that appeared on FDA's drug shortage list, the facility should maintain documentation ( e.g., a notation on the order for the compounded drug) regarding the status of the drug on FDA's drug shortage list at the time of compounding, distribution, and dispensing.

In contrast to section 503A, section 503B of the FD&C Act does not exclude radiopharmaceuticals. Therefore, FDA's overall policies regarding section 503B apply to the compounding of radiopharmaceutical drug products. However, we have developed specific policies that apply only to the compounding of radiopharmaceuticals by outsourcing facilities using bulk drug substances and to the compounding of radiopharmaceuticals by outsourcing facilities that are essentially copies of approved drugs when such compounding is limited to minor deviations, as that term is defined in the guidance. FDA issued this guidance in part to describe the conditions under which the Agency does not generally intend to take action for violations of sections 505 and 502(f)(1) of the FD&C Act when an outsourcing facility repackages radiopharmaceuticals for human use.

As discussed in the guidance, one condition is that if a radiopharmaceutical is repackaged by an outsourcing facility, the label on the immediate container (primary packaging, e.g., the syringe) of the repackaged product includes certain information. The guidance also provides that the label on the container from which the individual units are removed for administration (secondary packaging, e.g., the bag, box, or other package in which the repackaged products are distributed) includes: (1) The active and inactive ingredients, if the immediate product label is too small to include this information, and directions for use, including (as appropriate) dosage and administration and (2) the following information to facilitate adverse event reporting: https://www.fda.gov/medwatch and 1-800-FDA-1088.

This guidance describes the conditions under which FDA does not intend to take action for violations of sections 505 (concerning new drug applications), 502(f)(1) (concerning labeling with adequate directions for use), 582 ((21 U.S.C. 360eee-1) concerning drug supply chain security requirements), and (where specified in the guidance) section 501(a)(2)(B) of the FD&C Act (concerning CGMPs), when a state-licensed pharmacy, Federal facility, or outsourcing facility repackages certain prescription drug products. One condition discussed in the guidance is that if a drug is repackaged by an outsourcing facility, the label on the immediate container (primary packaging, e.g., the syringe) of the repackaged product includes certain information described in the guidance.

Another condition discussed in the guidance is that the label on the container from which the individual units are removed for administration (secondary packaging, e.g., the bag, box, or other package in which the repackaged products are distributed) includes: (1) The active and inactive ingredients, if the immediate product label is too small to include this information, and directions for use, including (as appropriate) dosage and administration, (2) directions for use, including, as appropriate, dosage and administration, and (3) the following information to facilitate adverse event reporting: https://www.fda.gov/medwatch and 1-800-FDA-1088.

Certain licensed biological products may sometimes be mixed, diluted, or repackaged in a way not described in the approved labeling for the product to meet the needs of a specific patient. As described in the guidance, biological products subject to licensure under section 351 of the Public Health Service (PHS) Act (42 U.S.C. 262) are not eligible for the statutory exemptions available to certain compounded drugs under sections 503A and 503B of the FD&C Act. In addition, a biological product that is mixed, diluted, or repackaged outside the scope of an approved Biologics License Application (BLA) is considered an unlicensed biological product under section 351 of the PHS Act.

This guidance document describes several conditions under which FDA does not intend to take action for violations of section 351 of the PHS Act and sections 502(f)(1), 582, and (where specified) 501(a)(2)(B) of the FD&C Act, when a State-licensed pharmacy, a Federal facility, or an outsourcing facility dilutes, mixes, or repackages certain biological products outside the scope of an approved BLA.

One condition discussed in the guidance is that if the labeling for the licensed biological product includes storage instructions, handling instructions, or both (for example, protect from light, do not freeze, keep at specified storage temperature), the labeling for the biological product that is mixed, diluted, or repackaged specifies the same storage conditions. Another condition described in the guidance is that, if the biological product is mixed, diluted, or repackaged by an outsourcing facility, the label on the immediate container (primary packaging, for example, the syringe) of the mixed, diluted, or repackaged product includes certain information described in the guidance. In addition, the guidance communicates that as a condition for biological products mixed, diluted, or repackaged by an outsourcing facility that, if the immediate product label is too small to bear the active and inactive ingredients, such information is included on the label of the container from which the individual units are removed for administration (secondary packaging, for example, the bag, box, or other package in which the mixed, diluted, or repackaged biological products are distributed).

The guidance also communicates our thinking about the condition for biological products mixed, diluted, or repackaged by an outsourcing facility that the label on the container from which the individual units are removed for administration include directions for use. These directions include, as appropriate, the dosage and administration and the following information to facilitate adverse event reporting: https://www.fda.gov/medwatch and 1-800-FDA-1088.

Finally, another condition described in the guidance is that outsourcing facilities maintain records of the testing performed in accordance with “Appendix A—Assigning a BUD for Repackaged Biological Products Based On Stability Testing” of the guidance for biological products repackaged by outsourcing facilities for which the beyond use date (BUD) is established based on a stability program conducted in accordance with Appendix A.

Section III.C of the guidance, “Licensed Allergenic Extracts for Subcutaneous Immunotherapy,” discusses the preparation of prescription sets (that is, licensed allergenic extracts that are mixed and diluted to provide subcutaneous immunotherapy to an individual patient) by a physician, a State-licensed pharmacy, a Federal facility, or an outsourcing facility. Another condition described in the guidance is that if the prescription set is prepared by an outsourcing facility, the label of the container from which the individual units of the prescription set are removed for administration (secondary packaging) includes the following information to facilitate adverse event reporting: https://www.fda.gov/medwatch and 1-800-FDA-1088. Each prescription set prepared by an outsourcing facility is also accompanied by instructions for use.

We estimate the burden of this information collection as follows:

As defined in 44 U.S.C. 3502(13), the term “recordkeeping requirement” means a requirement imposed on respondents to maintain specified records, as well as a requirement to “retain such records; notify third parties, the Federal Government, or the public of the existence of such records; disclose such records to third parties, the Federal Government, or the public; or report to third parties, the Federal Government, or the public regarding such records.” For purposes of our analysis, therefore, we have characterized the burden associated with the time and effort expended on the information collection recommendations discussed in the respective guidance documents as recordkeeping activities. At the same time, our findings show that compliance with recordkeeping requirements applicable to compounded and repackaged drug products is standard practice in the compounding and selling of these drug products under States' pharmacy laws and other State laws governing recordkeeping by healthcare professionals and healthcare facilities. We have therefore excluded from our estimate recordkeeping practices discussed in the respective guidance documents we consider usual and customary. We invite comment on this assumption.

We estimate 10 compounders annually will consult a prescriber to determine whether a compounded radiopharmaceutical has a change that produces a clinical difference for an identified individual patient as compared to the comparable approved radiopharmaceutical. We estimate that those compounders will document this determination on 250 prescriptions or orders for compounded radiopharmaceuticals. We assume consultation between the compounder and the prescriber and noting this determination on each prescription or order that does not already document this determination will take 3 minutes (0.05 hours) per prescription or order, for a total of approximately 12.5 hours.

We estimate a total of 2 outsourcing facilities annually will each design, test, and produce an average of 5 different labels for a total of 10 labels, as described in the guidance (including directions for use). We assume that designing, testing, and producing each label will take 30 minutes (0.5 hours) for each repackaged radiopharmaceutical, for a total of 5 hours. We consider that the provision to include “ https://www.fda.gov/medwatch” and “1-800-FDA-1088” is not a collection of information as defined in 5 CFR 1320.3(c)(2) and is therefore exempt from OMB review and approval under the PRA.

Based on current data for outsourcing facilities, we estimate 6 outsourcing facilities annually will submit an initial report identifying all drugs repackaged in the facility in the previous year. For the purposes of this estimate, each product's structured product labeling (SPL) submission is considered a separate response and therefore each facility's product report will include multiple responses. Taking into account that a particular product that is repackaged may come in different strengths and can be reported in a single SPL response, we estimate that each facility will average approximately 6 products.

Similarly, we estimate that 6 outsourcing facilities will submit an initial report identifying all drugs repackaged in the facility in the past year. Taking into account that a particular product that is repackaged may come in different strengths and can be reported in a single SPL response, we assume that each facility will average 6 products. Our estimate is based on current product reporting data. We expect that each product report will consist of multiple SPL responses per facility and assume preparing and electronically submitting this information will take up to 2 hours for each initial SPL response.

We also estimate 3 registered outsourcing facilities will submit a report twice each year (June and December) that identifies all drugs repackaged at the facility in the previous 6 months. We also estimate that an average of 3 facilities will prepare and submit 3 SPL responses and assume that preparing and submitting this information electronically will take 2 hours per response. If a product was not repackaged during a particular reporting period, outsourcing facilities do not need to send an SPL response for that product during that reporting period. We expect to receive no waiver requests from the electronic submission process for initial product reports and semiannual reports.

We estimate 15 outsourcing facilities annually who mix, dilute, or repackage biological products will each design, test, and produce 5 different labels, for a total of 75 labels that include the information set forth in section III.B—“Mixing, Diluting, or Repackaging Licensed Biological Products” of the guidance (including directions for use) as well as inclusion of storage instructions, handling instructions, or both. We assume that designing, testing, and producing each label will take 30 minutes (0.5 hours). We consider that the provision to include “ https://www.fda.gov/medwatch” and “1-800-FDA-1088” is not a collection of information as defined in 5 CFR 1320.3(c)(2) and is therefore exempt from OMB review and approval under the PRA.

We estimate that annually a total of 5 outsourcing facilities who prepare prescription sets will each include on the labels, packages, and/or containers of approximately 300 prescription sets the information set forth in section III.C “Licensed Allergenic Extracts for Subcutaneous Immunotherapy” of the draft guidance (including directions for use), for a total of 1,500 disclosures. We assume the initial process of designing, testing, and producing labeling and attaching to each prescription set each label, package, and/or container will take approximately 30 minutes (0.5 hours), for a total of approximately 750 hours.

Finally, we estimate that annually five outsourcing facilities who repackage biological products and establish a BUD in accordance with Appendix A—“Assigning a BUD for Repackaged Biological Products Based On Stability Testing” will maintain 150 records of the testing, as described in Appendix A of the guidance. We assume maintaining the records will take 5 minutes per record, for a total of 12.5 hours.

Our estimated burden for the information collection reflects program changes and adjustments. We are changing the scope of the information collection to include burden attendant to provisions found in the Agency guidance documents discussed in this notice and have adjusted our estimate to reflect a resulting increase of 955 hours and 1,873 responses annually.

I. Background

Section 204 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements.

In the Federal Register of September 14, 2018 (83 FR 46738), FDA announced the availability of a guidance entitled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.” The guidance describes how FDA has implemented its standards recognition program and is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-standards-premarket-submissions-medical-devices. Modifications to the initial list of recognized standards, as published in the Federal Register , can be accessed at https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/federal-register-documents.

These notices describe the addition, withdrawal, and revision of certain standards recognized by FDA. The Agency maintains on its website hypertext markup language (HTML) and portable document format (PDF) versions of the list of FDA Recognized Consensus Standards, available at https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/federal-register-documents. Additional information on the Agency's Standards and Conformity Assessment Program is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-and-conformity-assessment-program.

FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the Agency is recognizing for use in premarket submissions and other requirements for devices. FDA is incorporating these modifications to the list of FDA Recognized Consensus Standards in the Agency's searchable database. FDA is using the term “Recognition List Number: 055” to identify the current modifications.

In table 1, FDA describes the following modifications: (1) The withdrawal of standards and their replacement by others, if applicable; (2) the correction of errors made by FDA in listing previously recognized standards; and (3) the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards.

In section III, FDA lists modifications the Agency is making that involve new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 055.