This meeting is available to the public through the WebEx link above. If joining only via phone, callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Individuals who are deaf, deafblind and hard of hearing may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the call-in number found through registering at the web link provided above for 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 respective meeting. Written comments may be emailed to Victoria Moreno at vmoreno@usccr.gov. All written comments received will be available to the public.

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 the 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.

Members of the public can listen to these discussions. Committee meetings are available to the public through the above call in number. Any interested member of the public may call this number and listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. 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. Individuals who are deaf, deafblind and hard of hearing may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with 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 office within 30 days following the meeting. Written comments may be emailed to Corrine Sanders at csanders@usccr.gov. Persons who desire additional information may contact the Regional Programs Unit at (312) 353-8311.

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 via www.facadatabase.gov under the Commission on Civil Rights, Pennsylvania Advisory Committee link. Persons interested in the work of this Committee are directed to the Commission's website, http://www.usccr.gov, or may contact the Regional Programs Unit at the above email or street address.

Background: The Middle-Class Tax Relief and Job Creation Act of 2012 (codified at 47 U.S.C. 1401 et seq. ) (Act) established the FirstNet Authority as an independent authority within NTIA. The Act directs the FirstNet Authority to ensure the building, deployment, and operation of a nationwide interoperable public safety broadband network. The FirstNet Authority Board is responsible for making strategic decisions regarding the operations of the FirstNet Authority.

Matters to be Considered: The FirstNet Authority will post a detailed agenda for the Combined Board and Board Committees Meeting on FirstNet.gov prior to the meeting. The agenda topics are subject to change. Please note that the subjects discussed by the Board and Board Committees may involve commercial or financial information that is privileged or confidential, or other legal matters affecting the FirstNet Authority. As such, the Board may, by majority vote, close the meeting only for the time necessary to preserve the confidentiality of such information, pursuant to 47 U.S.C. 1424(e)(2).

Other Information: The public Combined Board and Board Committees Meeting is accessible to people with disabilities. Individuals requiring accommodations, such as sign language interpretation or other ancillary aids, are asked to notify Janell Smith at (202) 257-5929 or email: Janell.Smith@FirstNet.gov at least five (5) business days (April 27) before the meeting.

Records: The FirstNet Authority maintains records of all Board proceedings. Minutes of the Combined Board and Board Committees Meeting will be available on FirstNet.gov.

On March 4, 2022, Briggs & Stratton, LLC, the petitioner in the less-than-fair-value (LTFV) and CVD investigations, requested that Commerce initiate a circumvention inquiry with respect to dual-piston engines produced in and exported from China. 1 The petitioner alleges that dual-piston engines constitute merchandise altered in form or appearance in such minor respects that they should be included within the scope of the Orders, 2 pursuant to section 781(c) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.226(j). In addition, the petitioner alleges that dual-piston engines are later-developed merchandise and should be included within the scope of the Orders, pursuant to section 781(d) of the Act and 19 CFR 351.226(k).

On March 28, 2022, we extended the deadline to initiate this circumvention inquiry by 15 days, in accordance with the 19 CFR 351.226(d)(1), to April 18, 2022. 3 On April 7, 2022, FNA Group, Inc. (FNA) submitted comments asking that Commerce reject the petitioner's request that Commerce initiate a country-wide circumvention inquiry. 4

Atlantic HMS fisheries are managed under the dual authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act; 16 U.S.C. 1801 et seq. ) and the Atlantic Tunas Convention Act (ATCA; 16 U.S.C. 971 et seq. ). The 2006 Consolidated Atlantic HMS Fishery Management Plan (2006 Consolidated HMS FMP) and its amendments are implemented by regulations at 50 CFR part 635.

The Magnuson-Stevens Act requires the establishment of APs and requires NMFS to consult with and consider the comments and views of AP members during the preparation and implementation of FMPs or FMP amendments. 16 U.S.C. 1854(g)(1)(A)-(B). NMFS meets with the HMS AP approximately twice each year to consider potential alternatives for the conservation and management of Atlantic tunas, swordfish, billfish, and shark fisheries, consistent with the Magnuson-Stevens Act.

For this meeting, we anticipate discussing:

On February 23, 2022, the Council on Environmental Quality published an RFI to solicit feedback on the beta version of the Climate and Economic Justice Screening Tool (CEJST) (87 FR 10176). The original deadline to submit responses was April 25, 2022. This notice extends the period for response by 30 days to provide the public with additional time to provide feedback on the beta version of the CEJST. CEQ is providing this additional time in response to public requests for an extension of the response period. Written responses should be submitted on or before May 25, 2022.

Title: Associated Form; And OMB Number: Exchange Security Verification; Exchange Form 3900-013, Exchange Form 3900-002, Exchange Form 3900-006; OMB Control Number 0702-0135.

Needs and Uses: The information collection requirement is necessary for the processing of all Army and Air Force Exchange Service security clearance actions, to record security clearances issued or denied, and to verify eligibility for access to classified information or assignments to sensitive positions.

Affected Public: Individuals or households; Business or other for-profit.

Annual Burden Hours: 1,450.

Number of Respondents: 2,900.

Responses per Respondent: 1.

Annual Responses: 2,900.

Average Burden per Response: 30 minutes.

Frequency: On occasion

Respondents are individuals and/or households affiliated with Army and Air Force Exchange Service (Exchange) by assignment, employment contractual relationship, or because of an interservice support agreement on which personnel security clearance determination has been completed or is pending. Information collected is utilized to process the personnel security clearance of contractors and/or vendors to work at an Exchange facility, record the security clearances issued or denied, and to verify the eligibility for access to classified information or assignment to a sensitive position. In addition to utilizing the information for processing security clearances, the information may be used by Exchange executives for adverse personnel actions such as removal from sensitive duties, removal from contract agreement, denial to a restricted or sensitive area, and revocation of security clearance.

Title; Associated Form; and OMB Number: Exchange Employee and Retirement Benefit System; Exchange Form 1450-011, Exchange Form 1700-012; OMB Control Number 0702-0139.

Needs and Uses: The information collection requirement is necessary to administer several different benefits, pay, and retirement entitlements to eligible Exchange associates, former associates (retirees), their dependents, beneficiaries, spouses, and ex-spouses.

Affected Public: Individuals or households.

Annual Burden Hours: 3,446.67.

Number of Respondents: 10,340.

Responses per Respondent: 1.

Annual Responses: 10,340.

Average Burden per Response: 20 minutes.

Frequency: On occasion.

Respondents are active, former/retired or terminated Exchange personnel, which includes family members, beneficiaries, and survivors. Respondents provide Annuity Application and Beneficiary Designation on manual forms. Other benefits such as enrollment in health coverage, beneficiary designation, and other retirement options are done so primarily through electronic means. Health and 401K retirement collections are maintained by the service provider.

Title; Associated Form; and OMB Number: Research Performance Progress Report; OMB Control Number 0704-0527.

Type of Request: Extension.

Number of Respondents: 2,000.

Responses per Respondent: 2.

Annual Responses: 4,000.

Average Burden per Response: 6 hours.

Annual Burden Hours: 24,000.

Needs and Uses: The information collection requirement is necessary to: (a) Monitor Federal awards and ensure compliance with applicable terms and conditions of award regulations, policies, and procedures; (b) evaluate progress/completion in accordance with goals, aims, and objectives set forth in competing applications and to determine if the grantee satisfactorily met the objectives of the program; (c) evaluate grantee plans for the next budget period and any significant changes; (d) manage scientific programs; (e) plan future scientific initiatives; (f) determine funding for the next budget segment; (g) identify any publications, inventions, property disposition, and other required elements to close out the grant in a timely manner; and (h) complete reports to Congress, the public, and other Federal agencies.

Affected Public: Business or other for-profit; not-for-profit institutions; and state, local, or tribal government.

Frequency: Semi-annually.

Respondent's Obligation: Required to obtain or retain benefits.

OMB Desk Officer: Ms. Jasmeet Seehra.

You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments.

Instructions: All submissions received must include the agency name, Docket ID number, and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at https://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

DOD Clearance Officer: Ms. Angela Duncan.

Requests for copies of the information collection proposal should be sent to Ms. Duncan at whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.

Title; Associated Form; and OMB Number: Enlisted Retention and Promotion Barrier Analysis; OMB Control Number 0704-ERPB.

Type of Request: New.

Number of Respondents: 340.

Responses per Respondent: 1.

Annual Responses: 340.

Average Burden per Response: 88 minutes.

Annual Burden Hours: 498.67 hours.

Needs and Uses: The Fiscal Year 2021 National Defense Authorization Act (NDAA) (Section 551) requires DoD to conduct a barrier analysis to review demographic diversity patterns across the military life cycle, starting with enlistment or accession into the Armed Forces in order to: (i) Identify barriers to increasing diversity; (ii) develop and implement plans and processes to resolve or eliminate any barriers to diversity; and (iii) review the progress of the Armed Forces in implementing previous plans and processes to resolve or eliminate barriers to diversity. DoD's Office for Diversity, Equity, and Inclusion will carry out the NDAA requirement by completing the information collection ( i.e., Enlisted Retention and Promotion Barrier Analysis Study). Additionally, the DoD Board on Diversity and Inclusion, in its December 2020 report, recommended DoD address barriers confronted by minority members in the workplace.

Affected Public: Individuals or households.

Frequency: On occasion.

Respondent's Obligation: Voluntary.

OMB Desk Officer: Ms. Jasmeet Seehra.

You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments.

Instructions: All submissions received must include the agency name, Docket ID number, and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at https://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

DOD Clearance Officer: Ms. Angela Duncan.

Requests for copies of the information collection proposal should be sent to Ms. Duncan at whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.

Title; Associated Form; and OMB Number: Request for a Medical Exemption or Delay to the COVID-19 Vaccination Requirement; DD Form 3176; OMB Control Number 0704-0619.

Type of Request: Extension.

Number of Respondents: 180,000.

Responses per Respondent: 1.

Annual Responses: 180,000.

Average Burden per Response: 5 minutes.

Annual Burden Hours: 15,000.

Needs and Uses: Consistent with Executive Order 14043, of September 9, 2021, “Requiring Coronavirus Disease 2019 Vaccination for Federal Employees”, and included within the Safer Federal Workforce Task Force Guidance mandating all Federal employees be vaccinated by November 22, 2021, the DoD has established specific safety protocols for individuals fully vaccinated and not fully vaccinated against COVID-19. Individuals who are not fully vaccinated against COVID-19 by November 22, 2021, or who choose not to provide this information will be required to comply with applicable OMB. DoD is seeking approval of DD Form 3176, “Request for a Medical Exemption or Delay to the COVID-19 Vaccination Requirement,” which will be completed by employees who seek a medical exemption. The DD Form 3176 will be used by DoD staff and provided to employees to ensure they submit adequate information to support the exemption request. This form will also ensure the information collected is consistent among the components and minimize the need to seek additional evidence. Rendered decisions should be in accordance with guidelines established by the Safer Federal Workforce Task Force Guidance.

Affected Public: Individuals or households.

Frequency: On occasion.

Respondent's Obligation: Voluntary.

OMB Desk Officer: Ms. Jasmeet Seehra.

You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments.

Instructions: All submissions received must include the agency name, Docket ID number, and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at https://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

DOD Clearance Officer: Ms. Angela Duncan.

Requests for copies of the information collection proposal should be sent to Ms. Duncan at whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.

Title; Associated Form; and OMB Number: Vietnam War Commemoration Program Partner Events; DD Form 2956, DD Form 2957, DD Form 3027, DD Form 3028, DD Form 3029; OMB Control Number 0704-0500.

Type of Request: Extension.

Number of Respondents: 10,000.

Responses per Respondent: 2.

Annual Responses: 20,000.

Average Burden per Response: 15 minutes.

Annual Burden Hours: 5,000.

Number of Respondents: 4,000.

Responses per Respondent: 2.

Annual Responses: 8,000.

Average Burden per Response: 15 minutes.

Annual Burden Hours: 2,000.

Number of Respondents: 1,500.

Responses per Respondent: 1.

Annual Responses: 1,500.

Average Burden per Response: 15 minutes.

Annual Burden Hours: 375.

Number of Respondents: 500.

Responses per Respondent: 1.

Annual Responses: 500.

Average Burden per Response: 15 minutes.

Annual Burden Hours: 125.

Number of Respondents: 20.

Responses per Respondent: 1.

Annual Responses: 20.

Average Burden per Response: 15 minutes.

Annual Burden Hours: 5.

Needs and Uses: This information collection requirement is necessary to notify the United States of America Vietnam War Commemoration Program of Commemorative Partner's planned events. Information is submitted for inclusion on the program's events calendar and to request event support in the form of materials and/or speakers from the program. The information collection is necessary to obtain, vet, record, process and provide Certificates of Honor to be presented on behalf of a grateful nation by partner organizations. Additionally, this collection is necessary for the partner organizations to communicate to the Commemoration program the results of their events and lessons learned.

Affected Public: Businesses or other for-profits; Not-for-profit institutions; Federal Government; State, local or tribal government, or, by exception, eligible individuals or households.

Frequency: On occasion.

Respondent's Obligation: Voluntary.

OMB Desk Officer: Ms. Jasmeet Seehra.

You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments.

Instructions: All submissions received must include the agency name, Docket ID number, and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at https://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

DOD Clearance Officer: Ms. Angela Duncan.

Requests for copies of the information collection proposal should be sent to Ms. Duncan at whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.

Title; Associated Form; and OMB Number: Marine Corps Lodging Guest Registration and Feedback; OMB Control Number 0703-0072.

Type of Request: Revision.

Number of Respondents: 15,000.

Responses per Respondent: 1.11.

Annual Responses: 16,650.

Average Burden per Response: 6.8 minutes.

Annual Burden Hours: 1,887.

Needs and Uses: The information collection is necessary to keep a record of Marine Corps lodging reservations to ensure orderly room assignment and avoid improper booking; to record registration and payment of accounts; to verify proper usage by eligible patrons; for cash control; to gather occupancy data; to determine occupancy breakdown; to account for rentals and furnishings; and to collect data for customer satisfaction and marketing.

Affected Public: Individuals or households.

Frequency: On occasion.

Respondent's Obligation: Voluntary.

OMB Desk Officer: Ms. Jasmeet Seehra.

You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments.

Instructions: All submissions received must include the agency name, Docket ID number, and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at https://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

DOD Clearance Officer: Ms. Angela Duncan.

Requests for copies of the information collection proposal should be sent to Ms. Duncan at whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.

Title; Associated Form; and OMB Number: Non-Appropriated Fund Human Resource Management System; NAVMC Form 12000/499; OMB Control Number 0703-0071.

Type of Request: Revision.

Number of Respondents: 69,953.

Responses per Respondent: 1.

Annual Responses: 69,953.

Average Burden per Response: 30 minutes.

Annual Burden Hours: 34,976.5.

Needs and Uses: The information collection is necessary for Marine Corps Community Service (MCCS) to successfully manage and administer an effective and efficient recruiting and hiring process. MCCS's use of innovative technologies in the Non-Appropriated Fund Human Resource Management System (NAF HRMS) enables MCCS to streamline the employment application process, reduce processing and recruiter response times, and decrease the need for applicant calls and inquiries; therefore, improving the applicant's experience. The information collection is also necessary to allow MCCS retirees receiving an annuity to request changes to their current NAF Group medical, dental, or life insurance plans; their NAF Group Retirement plan; and/or their beneficiary information. Retirees request these changes via NAVMC Form 12000/499.

Affected Public: Business or other for-profit; individuals or households.

Frequency: On occasion.

Respondent's Obligation: Voluntary.

OMB Desk Officer: Ms. Jasmeet Seehra.

You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments.

Instructions: All submissions received must include the agency name, Docket ID number, and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

DOD Clearance Officer: Ms. Angela Duncan.

Requests for copies of the information collection proposal should be sent to Ms. Duncan at whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.

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: Native Hawaiian Education and Alaska Native Education Annual Performance Report.

OMB Control Number: 1810-NEW.

Type of Review: New Collection.

Respondents/Affected Public: State, Local, and Tribal Governments.

Total Estimated Number of Annual Responses: 102.

Total Estimated Number of Annual Burden Hours: 510.

Abstract: This is a request for a new Annual Performance Report (APR) information collection for the Title VI, Part B of the ESEA (Native Hawaiian Education), Title VI, Part C of the ESEA (Alaska Native Education), and Title XI, Section 11006 of the American Rescue Plan Act of 2021. The information shared with the Rural, Insular, and Native Achievement Program (RINAP) division will help ensure Native Hawaiian and Alaska Native Education program grantees make progress toward meeting program goals and objectives. Information collected will also inform the selection and delivery of technical assistance to grantees, allowing RINAP to better monitor the connection between grant administration and intended outcomes. Collection of APR information will also allow RINAP to proactively engage with grantees to identify potential compliance issues ahead of more comprehensive monitoring, decreasing the need for enforcement action and minimizing burden for grantees.

The IIJA created the CNC Program to provide up to $6 billion to award support in the form of credits to certified nuclear reactors operating in a competitive market that are projected to cease operations due to economic factors. DOE published in the Federal Register , a Notice of Intent and Request for Information regarding the establishment of a Civil Nuclear Credit Program on February 15, 2022, to solicit public input into the CNC Program design. 87 FR 8570. The Department used the responses to help inform its approach in creating the Guidance. The Guidance describes the CNC Program, program eligibility, certification criteria and bid submissions requirements for the first certification and bidding process. For the first credit auction, DOE has narrowed the field of eligible reactors to those reactors operating in a competitive market that are projected to imminently cease operations due to economic factors.

This document of the Department of Energy was signed on April 20, 2022, by Patricia A. Hoffman, Acting Director, Grid Deployment Office, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at https://www.regulations.gov, or in person, at the EPA Docket Center, WJC West Building, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit: https://www.epa.gov/dockets.

Abstract: The National Emission Standards for Hazardous Air Pollutants (NESHAP) for the regulations (40 CFR part 63, subpart WWWW) apply to both existing facilities and new facilities with reinforced plastic composites (RPC) production operations and processes. In general, all NESHAP standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to NESHAP.

Form Numbers: 5900-566.

Respondents/affected entities: Owners and operators of reinforced plastic composites production operations and processes.

Respondent's obligation to respond: Mandatory (40 CFR part 63, subpart WWWW).

Estimated number of respondents: 448 (total).

Frequency of response: Monthly, semiannually, annually.

Total estimated burden: 38,600 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $4,570,000 (per year), which includes $0 for annualized capital/startup and/or operation & maintenance costs.

Changes in the Estimates: The increase in burden from the most-recently approved ICR is due to an increase in adjustment(s). The adjustment increase in burden from the most-recently approved ICR is due to a change in regulatory requirements stemming from the 2020 RTR ICR (EPA ICR No. 1976.09) and the incorporation of its burden into the currently-approved ICR. Items added include burden for work practice requirements and time to record information. Work practice requirements have had a significant impact on the burden since facilities are complying with the current regulations through pollution prevention measures rather than add-on control devices. The time to complete semiannual compliance reports and time to train personnel have also been adjusted. Reporting emissions exceedances or no emissions exceedances is included in the semiannual compliance reports, and the time to train personnel was adjusted to represent facilities of any size. In addition, capital/startup and operation and maintenance costs have decreased from the previous ICR. It is estimated no new facilities will be subject to the rule and that existing facilities are complying with the rule using compliant materials instead of add-on control devices.

The Clean Air Act (CAA) provides that a small refinery  1 may at any time petition EPA for an extension of the exemption from the obligations of the RFS program for the reason of disproportionate economic hardship (DEH). 2 In evaluating such petitions, the EPA Administrator, in consultation with the Secretary of Energy, will consider the findings of a Department of Energy (DOE) study and other economic factors. 3 In a separate action issued on April 7, 2022, EPA denied 36 small refinery exemption (SRE) petitions for the 2018 compliance year by finding the petitioning refineries do not face DEH caused by compliance with their RFS obligations. 4

In the Compliance Action, 5 EPA is providing 31 specific small refineries with an alternative approach to demonstrating compliance with their RFS renewable volume obligations created by the SRE Denial. Each of the specified small refineries had previously been granted an SRE for the 2018 compliance year; however, each of their petitions again came before the Agency as the result of court remand. The Compliance Action is necessary because EPA has determined there are extenuating circumstances that warrant an alternative compliance demonstration approach that the specified small refineries may use to meet their 2018 obligations without retiring any additional RINs.

Section 307(b)(1) of the CAA governs judicial review of final actions by the EPA. This section provides, in part, that petitions for review must be filed in the United States Court of Appeals for the District of Columbia Circuit: (i) When the agency action consists of “nationally applicable . . . final actions taken by the Administrator,” or (ii) when such action is locally or regionally applicable, but “such action is based on a determination of nationwide scope or effect and if in taking such action the Administrator finds and publishes that such action is based on such a determination.” For locally or regionally applicable final actions, the CAA reserves to the EPA complete discretion whether to invoke the exception in (ii) described in the preceding sentence.

This final action is “nationally applicable” within the meaning of CAA section 307(b)(1). In the alternative, to the extent a court finds this final action to be locally or regionally applicable, the Administrator is exercising the complete discretion afforded to him under the CAA to make and publish a finding that this action is based on a determination of “nationwide scope or effect” within the meaning of CAA section 307(b)(1). 6 This final action provides an alternative approach to demonstrating compliance with the 2018 obligations for 31 small refineries across the country and applies to small refineries located within 16 states in 7 of the 10 EPA regions and in 7 different Federal judicial circuits. 7 This final action is based on the extenuating circumstances applicable to these 31 small refineries and the impacts their compliance with their newly created 2018 obligations under the existing compliance scheme would have on the RFS program. For these reasons, this final action is nationally applicable or, alternatively, the Administrator is exercising the complete discretion afforded to him by the CAA and hereby finds that this final action is based on a determination of nationwide scope or effect for purposes of CAA section 307(b)(1) and is hereby publishing that finding in the Federal Register .

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the District of Columbia Circuit by June 24, 2022.

Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at https://www.regulations.gov, or in person at the EPA Docket Center, WJC West Building, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit: https://www.epa.gov/dockets.

Abstract: The New Source Performance Standards (NSPS) for Secondary Lead Smelters (40 CFR part 60, subpart L) apply to existing facilities and new secondary lead smelting facilities: Any pot furnace of more than 250 kg (550 lb) charging capacity, blast (cupola) furnaces, and reverberatory furnaces. The affected facilities include any facility producing lead from a lead bearing scrap material by smelting to the metallic form. Blast furnace means any furnace used to recover metal from slag. Reverberatory furnaces include furnaces of various types, e.g., stationary, rotating, rocking and tilting. New facilities include those that commenced construction, modification, or reconstruction after the date of proposal. This information is being collected to assure compliance with 40 CFR part 60, subpart L.

In general, all NSPS standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to NSPS.

Form Numbers: None.

Respondents/affected entities: Secondary lead smelting facilities.

Respondent's obligation to respond: Mandatory (40 CFR part 60, subpart L).

Estimated number of respondents: 10 (total).

Frequency of response: Initially.

Total estimated burden: 26 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $3,130 (per year), which includes $0 in annualized capital/startup and/or operation & maintenance costs.

Changes in the Estimates: The adjustment decrease in burden from the most recently-approved ICR is due to a decrease in the number of sources. There is a decrease in the number of estimated sources from 12 to 10 due to consolidation within the sector. The reduced number of estimated sources also led to a decrease in the number of responses. There are no capital/startup and/or operation and maintenance costs associated with the rule.

Supporting documents, which explain in detail the information that the EPA will be collecting. are available in the public docket for this ICR. The docket can be viewed online at https://www.regulations.gov, or in person at the EPA Docket Center, WJC West Building, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit: http://www.epa.gov/dockets.

Abstract: Owners and operators of paper and other web coating facilities are required to comply with reporting and record keeping requirements for the General Provisions (40 CFR part 63, subpart A), as well as for the applicable specific standards in 40 CFR part 63 Subpart JJJJ. This includes submitting initial notifications, performance tests and periodic reports and results, maintaining records of materials usage, and any period during which the add-on control system is inoperative. These reports are used by EPA to determine compliance with these standards.

Form Numbers: 5900-532.

Respondents/affected entities: Owners and operators of new and existing paper and other web coating facilities.

Respondent's obligation to respond: Mandatory (40 CFR part 63, subpart JJJJ).

Estimated number of respondents: 171 (total).

Frequency of response: Initially, semiannually.

Total estimated burden: 17,300 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $3,030,000 (per year), which includes $975,000 in annualized capital/startup and/or operation & maintenance costs.

Changes in the Estimates: There is no significant change in burden from the most-recently approved ICR. The change in burden from the most-recently approved ICR, as currently-identified in the OMB Inventory of Approved Burdens, is due to an increase in the number of respondents that are subject to this rule. The rule was previously amended in 2020 on both July 09 and November 19. This ICR adjusts the burden to account for the growth rate within the industry following the July 9, 2020, final rule ICR. The rule is not anticipated to change over the next three years. The growth rate for this industry is low at one new source per year. Due to these adjustments, there is an overall increase in burden, although the rounded burden hours have not changed from the prior ICR. The capital/startup and operation and maintenance (O&M) costs have also been adjusted to account for growth. The overall result is an increase in costs.

Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit https://www.epa.gov/dockets.

Abstract: This ICR covers the usage of TANAs to solicit feedback from members of the affected community in order to determine how the community is receiving technical information about a Superfund remedial or removal site; whether the community requires additional assistance in order to understand and respond to site-related technical information; and whether there are organizations in the community that are interested or involved in site-related issues and capable of acting as an appropriate conduit for technical assistance services to the affected community. EPA estimates that for each TANA it conducts, 20 individuals are interviewed per site via direct face-to-face interaction, phone, or virtual call at five sites, with an approximate total of 100 individuals interviewed each year. Responses to the collection of information are voluntary and the names of respondents will be protected by the Privacy Act. The information obtained from each TANA will help ensure the community's needs for technical information assistance are defined as early in the remedial/removal process as possible and enable meaningful community involvement in the Superfund decision-making process. Additionally, the TANA process produces a blueprint for designing a coordinated effort to meet the community's needs for additional technical assistance while minimizing the overlap of services provided.

Form Numbers: None.

Respondents/affected entities: Local, state, and tribal government officials, potentially responsible party (PRP) representatives, community organizations, businesses and individuals who may be impacted by a Superfund site or a removal action lasting 120 days or longer. These community members voluntarily participate in community involvement activities throughout the remedial phase of the Superfund process. SIC Codes are Occupational Safety and Health Administration's (OSHA's) Standard Industrial Classification System used to identify different groups. Local/state governments are categorized as Division J: Public Administration, Major Group 95: Administration of Environmental Quality, subgroup 9511: Air and Water Resource and Solid Waste Management. The other respondents, community members, do not have a SIC Code as they do not constitute an industry.

Respondent's obligation to respond: Voluntary.

Estimated number of respondents: 100. (20 per TANA at five sites).

Frequency of response: Once during either a removal cleanup lasting 120 days or longer or a remedial cleanup of a site. Each TANA interview is expected to last approximately one hour in duration.

Total estimated burden: 100 hours (per year). Burden is defined at 5 CFR 1320.03(b).

Total estimated cost: $2,587 (per year), includes $0 annualized capital or operation & maintenance costs.

Changes in the Estimates: A decrease of 450 hours in the total respondent burden hours is estimated during the three-year period as compared to the last collection period. The number of individual TANAs sharply declined, from 25 to five per year, thus decreasing the overall number of respondents voluntarily participating in this information request.

Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit https://www.epa.gov/dockets.

Abstract: EPA is responsible for the regulation of pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). The EPA regulations at 40 CFR part 26 protect subjects of “third-party” research ( i.e., research that is not conducted or sponsored by EPA). In addition to other protections, the regulations require affected entities to submit information to EPA and an institutional review board (IRB) prior to initiating, and to the EPA upon the completion of, certain studies that involve human research participants. The information collection activity consists of activity-driven reporting and recordkeeping requirements for those who intend to conduct research for submission to EPA under the pesticide laws. If such research involves intentional exposure of human subjects, these individuals (respondents) are required to submit study protocols to the EPA and a cognizant local Human Subjects IRB before such research is initiated so that the scientific design and ethical standards that will be employed during the proposed study may be reviewed and approved. Also, respondents are required to submit information about the ethical conduct of completed research that involved human subjects when such research is submitted to the EPA. This renewal ICR estimates the third-party response burden from complying with the requirements in 40 CFR part 26.

Form Numbers: None.

Respondents/affected entities: Any entities that submits to EPA under FIFRA and/or FFDCA protocols and study reports for environmental research involving human subjects.

Respondent's obligation to respond: Mandatory under 40 CFR part 26.

Estimated number of respondents: 10 (total).

Frequency of response: On occasion.

Total estimated burden: 8,276 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $859,215 (per year), includes $0 annualized capital or operation & maintenance costs.

Changes in the Estimates: There is an estimated decrease of 1,966 hours in the total estimated respondent burden compared with the ICR currently approved by OMB. This decrease is a result of the anticipated number of responses per year for the next three years based on comments received from stakeholders. This change is an adjustment.

Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit https://www.epa.gov/dockets.

Abstract: This ICR will cover the information collection activities and burden associated with the reporting and recordkeeping obligations of individuals, businesses, organizations, and government entities participating in or collaborating with EPA's Safer Choice program. The programs are designed to: Improve data efficiency by electronic data collection via a cloud-based Salesforce system called the Safer Choice Community; monitor the public's awareness of the Safer Choice program and label; and clarify the Safer Choice Partner of the Year Awards application process and form.

Form numbers: 9600-017, 9600-018, 9600-019, 9600-020, 9600-21, 9600-022, and 9600-023.

Respondents/affected entities: The ICR provides a list of the North American Industrial Classification System (NAICS) codes associated with the various industries most likely affected by the paperwork activities covered in this ICR.

Respondent's obligation to respond: Voluntary.

Frequency of response: On occasion.

Estimated number of respondents: 7,566 (total).

Total estimated burden: 9,696 hours. Burden is defined at 5 CFR 1320.3(b).

Total estimated costs: $751,942 (per year). This includes an estimated burden cost of $206,342 and an estimated cost of $545,600 for non-burden hour paperwork costs, e.g., capital investment or maintenance and operational costs.

Changes in the estimates: The total combined burden from the two approved ICRs that are being combined in this request is 7,118 hours (4,788 hours and 2,330 hours, respectively). The total burden requested for this ICR is 9,696 hours, resulting in an overall increase of 2,578 hours from the estimated combined burden compared with that currently approved by OMB. The difference is primarily due to the inclusion of the activities and burden associated with Partner of the Year Award activities (1,575 hours) and minor adjustments were made in EPA's estimates of the number of respondents and of the burden. Specifically, the burden for previously approved EPA ICR No. 2487.02 increased by 1,003 hours (from 2,330 to 3,333 hours). The burden for previously approved EPA ICR No. 2302.03 has not changed, remaining at 4,788 hours. The total combined cost for the existing ICRs is $545,600 ($545,600 and $0, respectively). The total cost requested for this ICR remains the same. These changes are adjustments.

Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at https://www.regulations.gov, or in person, at the EPA Docket Center, WJC West Building, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit: https://www.epa.gov/dockets.

Abstract: The National Emission Standards for Hazardous Air Pollutants (NESHAP) for Asbestos (40 CFR part 61, subpart M) regulations apply to either the demolition and/or renovation of facilities; the disposal of asbestos waste; asbestos milling, manufacturing and fabricating; the use of asbestos on roadways; asbestos waste converting facilities; and the use of asbestos insulation and sprayed-on materials. In general, all NESHAP standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to NESHAP.

Form Numbers: None.

Respondents/affected entities: Owners and operators of demolition and renovation of facilities, asbestos cement (A/C) pipe replacement projects (ACPRPs), asbestos waste disposal, asbestos milling, manufacturing and fabricating, use of asbestos on roadways, asbestos waste converting facilities, and the use of asbestos insulation and sprayed-on materials.

Respondent's obligation to respond: Mandatory (40 CFR part 61, subpart M).

Estimated number of respondents: 9,771 (total).

Frequency of response: Quarterly, semiannually, annually.

Total estimated burden: 297,000 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $35,100,000 (per year), which includes $0 in annualized capital/startup and/or operation & maintenance costs.

Changes in the Estimates: There is an increase in the total estimated burden as currently identified in the OMB Inventory of Approved Burdens. The change is due to the removal of burden associated with electronic reporting by either demolition or renovation facilities. The previous ICR renewal introduced a pilot program for demolition/renovation facilities, which allowed for voluntary submission of certain notifications using electronic reporting, as available. However, there are no regulatory requirements for electronic submission of reports in 40 CFR part 61, subpart M; therefore, this ICR does not assign a regulatory burden for electronic submittal of reports.

The Clean Air Act (CAA) provides that a small refinery  1 may at any time petition EPA for an extension of the exemption from the obligations of the RFS program for the reason of disproportionate economic hardship (DEH). 2 In evaluating such petitions, the EPA Administrator, in consultation with the Secretary of Energy, will consider the findings of a Department of Energy (DOE) study and other economic factors. 3

In the SRE Denial, 4 we conducted an extensive analysis and review of information provided to EPA by small refineries in their SRE petitions and in the comments submitted in response to the Proposed Denial. 5 We sought comment on all aspects of the Proposed Denial, including on our conclusions that the CAA requires small refineries to demonstrate that DEH is caused by compliance with the RFS program. We also sought comment on our economic analyses and conclusion that no small refineries face disproportionate costs of compliance due to the RFS program, no economic hardship, and, therefore, no DEH caused by RFS compliance. We requested additional data that would show the relationship between RFS compliance costs and the price of transportation fuel blendstocks. We also sought comment on our proposed change in approach to SRE eligibility based on receipt of the original statutory exemption, and our proposed decision to deny all pending SRE petitions based on the proportional nature of the RFS requirements and our findings regarding RIN cost passthrough. We considered all the comments received and have responded to them in the SRE Denial and its corresponding appendices.

In the SRE Denial, we find that all refineries face the same costs to acquire RINs regardless of whether the RINs are created through the act of blending renewable fuels or are purchased on the open market. This happens because the market price for these fuels increases to reflect the cost of the RIN, much as it would increase in response to higher crude prices. In other words, this increased price for gasoline and diesel fuel allows obligated parties to recover their RIN costs through the market price of the fuel they produce. Because the market behaves this way for all parties subject to the RFS program, there is no disproportionate cost to any party, including small refineries, and no hardship given that the costs are recovered. As a result, we conclude that small refineries do not face DEH. Given this conclusion and the other reasons described in the SRE Denial, we have denied 36 SRE petitions by finding the petitioning refineries do not face DEH caused by compliance with their RFS obligations.

Section 307(b)(1) of the CAA governs judicial review of final actions by the EPA. This section provides, in part, that petitions for review must be filed in the United States Court of Appeals for the District of Columbia Circuit: (i) When the agency action consists of “nationally applicable . . . final actions taken by the Administrator,” or (ii) when such action is locally or regionally applicable, but “such action is based on a determination of nationwide scope or effect and if in taking such action the Administrator finds and publishes that such action is based on such a determination.” For locally or regionally applicable final actions, the CAA reserves to the EPA complete discretion whether to invoke the exception in (ii) described in the preceding sentence.

This final action is “nationally applicable” within the meaning of CAA section 307(b)(1). In the alternative, to the extent a court finds this final action to be locally or regionally applicable, the Administrator is exercising the complete discretion afforded to him under the CAA to make and publish a finding that this action is based on a determination of “nationwide scope or effect” within the meaning of CAA section 307(b)(1). 6 This final action denies petitions for exemptions from the RFS program for over 30 small refineries across the country and applies to small refineries located within 18 states in 7 of the 10 EPA regions and in 8 different Federal judicial circuits. 7 This final action is based on EPA's revised interpretation of the relevant CAA provisions and the RIN discount and RIN cost passthrough principles that are applicable to all small refineries no matter the location or market in which they operate. For these reasons, this final action is nationally applicable or, alternatively, the Administrator is exercising the complete discretion afforded to him by the CAA and hereby finds that this final action is based on a determination of nationwide scope or effect for purposes of CAA section 307(b)(1) and is hereby publishing that finding in the Federal Register .

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the District of Columbia Circuit by June 24, 2022.

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.

EPA has received applications to register pesticide products containing active ingredients not included in any currently registered pesticide products. Pursuant to the provisions of FIFRA section 3(c)(4) (7 U.S.C. 136a(c)(4)), EPA is hereby providing notice of receipt and opportunity to comment on these applications. Notice of receipt of these applications does not imply a decision by the Agency on these applications. For actions being evaluated under EPA's public participation process for registration actions, there will be an additional opportunity for public comment on the proposed decisions. Please see EPA's public participation website for additional information on this process ( https://www2.epa.gov/pesticide-registration/public-participation-process-registration-actions ).

1. File Symbol: 2375-A. Docket ID number: EPA-HQ-OPP-2022-0317. Applicant: Chr. Hansen, Inc., 16300 W Lincoln Ave., New Berlin, WI 53151. Product name: CH4000. Active ingredient: Fungicide and nematicide— Bacillus subtilis strain CH4000 at 100%. Proposed use: For seed treatment and applications to soil. Contact: BPPD.

2. File Symbol: 2375-L. Docket ID number: EPA-HQ-OPP-2022-0317. Applicant: Chr. Hansen, Inc., 16300 W Lincoln Ave., New Berlin, WI 53151. Product name: Kansas 3 SC. Active ingredient: Fungicide and nematicide— Bacillus subtilis strain CH4000 at 3.33%, Bacillus paralicheniformis strain CH2970 at 3.33%, and Bacillus paralicheniformis strain CH0273 at 3.33%. Proposed use: For seed treatment and applications to soil. Contact: BPPD.

3. File Symbol: 2375-T. Docket ID number: EPA-HQ-OPP-2022-0317. Applicant: Chr. Hansen, Inc., 16300 W Lincoln Ave., New Berlin, WI 53151. Product name: Kansas 3 WP. Active ingredient: Fungicide and nematicide— Bacillus subtilis strain CH4000 at 20%, Bacillus paralicheniformis strain CH2970 at 20%, and Bacillus paralicheniformis strain CH0273 at 20%. Proposed use: For seed treatment and applications to soil. Contact: BPPD.

4. File Symbol: 2375-U. Docket ID number: EPA-HQ-OPP-2022-0317. Applicant: Chr. Hansen, Inc., 16300 W Lincoln Ave., New Berlin, WI 53151. Product name: CH0273. Active ingredient: Fungicide and nematicide - Bacillus paralicheniformis strain CH0273 at 100%. Proposed use: For seed treatment and applications to soil. Contact: BPPD.

Authority: 7 U.S.C. 136 et seq.

This is a summary of the Commission's document (Public Notice), in ET Docket No. 18-295 and GN Docket No. 17-183, DA 22-253, released on March 10, 2022. The full text of this document is available for public inspection and may be downloaded at: https://www.fcc.gov/document/oet-seeks-comment-following-court-remand-6-ghz-band-order.

In the Public Notice, the Office of Engineering and Technology invites comments in connection with the remand by the United States Court of Appeals for the District of Columbia Circuit of the Commission's 6 GHz Report and Order. On February 22, 2022, the court issued its mandate.

The Commission's 6 GHz Report and Order “open[ed up] the entire 6 GHz band [(5.925-7.125 GHz)] for unlicensed indoor lower power access points.” The Commission found that “[t]hese access points will be ideal for connecting devices in homes and businesses such [as] smartphones, tablet devices, laptops, and Internet-of-Things devices to the Internet.” The Commission adopted several requirements to “protect the various incumbent-licensed services in the band, including fixed microwave services, various other fixed and mobile services, and fixed-satellite services.”

Among other things, the 6 GHz Report and Order required that the operation of devices relying on indoor low power access points be: “(1) limited to indoor operation” whereby “the signals transmitted by these unlicensed devices will be significantly attenuated when passing through the walls of buildings[;]” “(2) required to use a contention-based protocol,” such as a “listen before talk . . . scheme[;]” and “(3) subject to low-power operation,” which, as relevant here, means “a maximum radiated power spectral density of 5 dBm per 1 megahertz.” The Commission concluded that “the[se] restrictions and requirements . . . for indoor use of low power access points eliminat[e] any significant risk of causing harmful interference.”

Petitioners representing licensed commercial wireless service providers, electric utilities, public safety entities, and broadcasters operating in the 6 GHz band sought judicial review, asserting that the 6 GHz Report and Order contravened the Communications Act of 1934, as amended, and the Administrative Procedure Act.

The D.C. Circuit largely rejected these challenges. Holding that “petitioners have failed to provide a basis for questioning the Commission's conclusion that the [ 6 GHz Report and Order ] will protect against a significant risk of harmful interference,” the court “den[ied] the petitions for review in all respects save one.”

The one issue as to which the court granted review involved a claim by the National Association of Broadcasters (NAB) “that because mobile operators frequently work indoors, the provisions of the [ 6 GHz Report and Order ] designed to restrict low-power routers to indoor operation offer mobile licensees little protection”, and that therefore, the Commission should have “reserve[d] a sliver of [the 6 GHz] band exclusively for mobile licensees.” In support of its claim, NAB argued that “after the Commission allowed unlicensed access in the 2.4 GHz band, `a contention-based protocol . . . failed to protect . . . licensed users[,] rendering that band partially unusable.' ”

The court ruled that “[t]he Commission never responded to [NAB's] complaints about interference in the 2.4 GHz band,” and that “[a]lthough the Commission cited a study to support its conclusion that the [ 6 GHz Report and Order ] sufficiently protects mobile operators, that study does not rebut the Association's claims about interference in the 2.4 GHz band.” The court nevertheless declined to vacate the 6 GHz Report and Order, observing that “ `[i]t is conceivable that the Commission may be able to explain' why its experience in the 2.4 GHz band supports its ability to protect licensed mobile operators from harmful interference” and agreeing with the Commission that “ ‘vacating this order would be incredibly disruptive given the fact that devices have already started to be deployed . . . .' ”

In the Public Notice, the Office of Engineering and Technology seeks comment on NAB's arguments in the Commission's proceeding regarding broadcasters' experience in the 2.4 GHz band, how that experience relates to the kinds of contention-based protocol operations prescribed for indoor use in the 6 GHz rules, and whether the 2.4 GHz experience warrants reservation of a portion of the 6 GHz band for mobile indoor operations or any other modification to the Commission's 6 GHz rules. The Office of Engineering and Technology emphasizes that, in light of the limited scope of the court's remand, it does not seek comment on any other aspects of the 6 GHz Report and Order.

Interested parties may file comments and reply comments on or before the dates indicated on the first page of this document. Comments may be filed using the Commission's Electronic Comment Filing System (ECFS). See Electronic Filing of Documents in Rulemaking Proceedings, 63 FR 24121 (1998).

Ex Parte Rules. The proceeding this Notice initiates shall be treated as a “permit-but-disclose” proceeding in accordance with the Commission's ex parte rules. Persons making ex parte presentations must file a copy of any written presentation or a memorandum summarizing any oral presentation within two business days after the presentation (unless a different deadline applicable to the Sunshine period applies). Persons making oral ex parte presentations are reminded that memoranda summarizing the presentation must (1) list all persons attending or otherwise participating in the meeting at which the ex parte presentation was made, and (2) summarize all data presented and arguments made during the presentation. If the presentation consisted in whole or in part of the presentation of data or arguments already reflected in the presenter's written comments, memoranda or other filings in the proceeding, the presenter may provide citations to such data or arguments in his or her prior comments, memoranda, or other filings (specifying the relevant page and/or paragraph numbers where such data or arguments can be found) in lieu of summarizing them in the memorandum. Documents shown or given to Commission staff during ex parte meetings are deemed to be written ex parte presentations and must be filed consistent with § 1.1206(b) of the Commission's rule. In proceedings governed by § 1.49(f) of the Commission's rule or for which the Commission has made available a method of electronic filing, written ex parte presentations and memoranda summarizing oral ex parte presentations, and all attachments thereto, must be filed through the electronic comment filing system available for that proceeding, and must be filed in their native format ( e.g., .doc, .xml, .ppt, searchable .pdf). Participants in this proceeding should familiarize themselves with the Commission's ex parte rules.

The information collected is used by PBS to evaluate a contractor's proposals, negotiate contract modifications, evaluate a contractor's progress, and review payment requests during contract administration. The clause was previously GSAR 552.236-78 Shop Drawings, Coordination Drawings, and Schedules. The clause is simplified, including removing the requirement for a specific number of prints and copies of various submittals. This simplification will ease the compliance burden for the contractor during contract administration from the current state.

Public reporting burden for GSAR 552.236-72 Submittals is estimated to average .25 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

The annual reporting burden is estimated as follows:

Respondents: 890.

Responses per respondent: 5.

Total annual responses: 4,452.

Preparation hours per response: .25.

Total response burden hours: 1,113.

Public comments are particularly invited on: Whether this collection of information is necessary and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected.

Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the GSA Regulatory Secretariat Division, by calling 202-501-4755 or emailing GSARegSec@gsa.gov.

Title: Request for a Medical Exception to the Covid-19 Vaccination Requirement.

Agency Form Number: OGE Form 319.

Abstract: The OGE Form 319 collects information necessary to document the consideration, decision, and implementation of OGE employee requests for reasonable accommodation from the COVID vaccination requirement set forth in Executive Order 14043, Requiring Coronavirus Disease 2019 Vaccination for Federal Employees (Sept. 9, 2021).

OMB Control Number: 3209-0011.

Type of Information Collection: Extension of a currently approved collection.

Type of Review Request: Regular.

Affected public: Medical providers who are asked to provide documentation in support of an employee's request for a medical exception to the requirement for COVID-19 vaccination.

Estimated Annual Number of Respondents: 1 (based on an estimate of five respondents over a ten year period, rounded up).

Estimated Time per Response: 10 minutes.

Estimated Total Annual Cost Burden (in dollars): 17.

A Federal Register Notice with a 60-day comment period soliciting comments on this information collection was published on February 10, 2022 (87 FR 7838). OGE received one response to that notice. The comment did not address the substance of information collection; it opposed it on the basis of the outstanding injunction against implementation of the vaccination requirement issued pursuant to E.O. 14043. As noted in the first notice and again below, OGE will not process requests for a medical exception or request the submission of any medical information related to a request for an exception pursuant to E.O. 14043 while the injunction remains in place. But OGE may nevertheless receive information regarding a medical exception. Therefore, clearance of the information collection is necessary.

Request for Comments: OGE is publishing this second round notice of its intent to request paperwork clearance renewal for the OGE Form 319. Public comment is invited specifically on the need for and practical utility of this information collection, the accuracy of OGE's burden estimate, the enhancement of quality, utility and clarity of the information collected, and the minimization of burden (including the use of information technology). Comments received in response will become a matter of public record.

A Notice Regarding Injunctions: The vaccination requirement issued pursuant to E.O. 14043 is currently the subject of a nationwide injunction. While that injunction remains in place, OGE will not process requests for a medical exception from the COVID-19 vaccination requirement pursuant to E.O. 14043. OGE will also not request the submission of any medical information related to a request for an exception from the vaccination requirement pursuant to E.O. 14043 while the injunction remains in place. But OGE may nevertheless receive information regarding a medical exception. That is because, if OGE were to receive a request for an exception from the COVID-19 vaccination requirement pursuant to E.O. 14043 during the pendency of the injunction, OGE will accept the request, hold it in abeyance, and notify the employee who submitted the request that implementation and enforcement of the COVID-19 vaccination requirement pursuant to E.O. 14043 is currently enjoined and that an exception therefore is not necessary so long as the injunction is in place. In other words, during the pendency of the injunction, any information collection related to requests for medical exception from the COVID-19 vaccination requirement pursuant to E.O. 14043 is not undertaken to implement or enforce the COVID-19 vaccination requirement.

Meeting Accessibility: The CPSTF meeting will be held virtually via web conference.

CDC will send web conference information to registrants upon receipt of their registration. All meeting attendees must register by June 1, 2022 to receive the web conference information for meeting. CDC will email web conference information from the CPSTF@cdc.gov mailbox.

To register for the meeting, individuals should send an email to CPSTF@cdc.gov and include the following information: Name, title, organization name, organization address, phone, and email.

Public Comment: Individuals who would like to make public comments during the June meeting must state their desire to do so with their registration and provide their name and organizational affiliation and the topic to be addressed (if known). The requestor will receive instructions for the public comment process for this virtual meeting after the request is received. A public comment period follows the CPSTF's discussion of each systematic review and will be limited, up to three minutes per person. Public comments will become part of the meeting summary.

Background on the CPSTF: The CPSTF is an independent, nonfederal panel whose members are appointed by the CDC Director. CPSTF members represent a broad range of research, practice, and policy expertise in prevention, wellness, health promotion, and public health. The CPSTF was convened in 1996 by HHS to identify community preventive programs, services, and policies that increase health, longevity, save lives and dollars, and improve Americans' quality of life. CDC is mandated to provide ongoing administrative, research, and technical support for the operations of the CPSTF. During its meetings, the CPSTF considers the findings of systematic reviews of existing research and practice-based evidence and issues recommendations. CPSTF recommendations are not mandates for compliance or spending. Instead, they provide information about evidence-based options that decision makers and affected organizations and individuals can consider when they are determining what best meets the specific needs, preferences, available resources, and constraints of their jurisdictions and constituents. The CPSTF's recommendations, along with the systematic reviews of the evidence on which they are based, are compiled on the Community Guide website ( www.thecommunityguide.org ).

Matters proposed for discussion: The agenda will consist of deliberation on systematic reviews of literature. Topics will include Cancer Screening; Nutrition, Physical Activity, and Obesity; Social Determinants of Health; Mental Health; and Substance Use. The meeting is open to the public. Information regarding the start and end times for each day, and any updates to agenda topics, will be available on the Community Guide website ( www.thecommunityguide.org ) closer to the date of the meeting.

The meeting agenda is subject to change without notice.

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment:

1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Medicare Prescription Drug Benefit Program; Use: Plan sponsor and State information is used by CMS to approve contract applications, monitor compliance with contract requirements, make proper payment to plans, and ensure that correct information is disclosed to potential and current enrollees. Form Number: CMS-10141 (OMB control number: 0938-0964); Frequency: Annually; Affected Public: Private Sector and Business or other for-profit institutions; Number of Respondents: 11,771,497; Total Annual Responses: 675,231,213; Total Annual Hours: 9,261,354. (For policy questions regarding this collection contact Chad D. Buskirk at 410-786-1630.)

2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Data Use Agreement (DUA) Form, Research Identifiable Files Request Packet, and Data Management Plan; Use: CMS is permitted to disclose data files for approved research purposes in compliance with 45 CFR 164.512(i). Researchers requesting research identifiable files (RIF) must, as part of the request process, complete a research request packet that provides CMS with information pertaining to the research study, including describing how the research results/findings will be disseminated, as well as the data files being requested. Should CMS approve the research request, the data requestor enters into a Data Use Agreement (DUA). This data collection is necessary to ensure that disclosures of data for research purposes comply with federal laws and regulations as well as CMS policy.

Researchers requesting RIF files also must complete a Data Management Plan Self-Attestation Questionnaire (DMP SAQ). A DMP SAQ is required each time a DUA is established. Both the DUA and the DMP SAQ forms are valid for one year from the date of approval and are renewable at expiration. If the environment described in a DMP SAQ is the same for multiple DUAs from a single organization, the same DMP SAQ can be used across the DUAs, provided it has not expired.

The DMP SAQ is a technical, evidence-based questionnaire that DUA users must complete as part of the data request packet. The DMP SAQ will enable CMS to evaluate researcher data systems to ensure that CMS data are adequately secured and appropriately protected, as per the Privacy Act and the HIPAA Privacy Rule. The DMP SAQ also allows CMS to measure compliance through the implementation of security and privacy controls as outlined in the National Institute of Standards and Technology (NIST) Special Publication 800-53 and the Centers for Medicare & Medicaid Services (CMS) Information Security and Acceptable Risk Safeguards (ARS). The second component of the DMP SAQ is to provide ongoing oversight. All organizations will be subject to routine audits of the environments used to store and process CMS data, as described in their organizational-level DMP SAQ. Form Number: CMS-R-235 (OMB control number: 0938-0734); Frequency: Occasionally; Affected Public: Private Sector, State, Local, or Tribal Governments, Federal Government (Business or for-profits and Not-for-profit institutions); Number of Respondents: 9,655; Total Annual Responses: 9,655; Total Annual Hours: 3,875. (For policy questions regarding this collection, contact Kari A. Gaare at 410-786-8612.)

3. Type of Information Collection Request: Reinstatement of a previously approved collection; Title of Information Collection: Payment Collections Operations Contingency Plan; Use: Under sections 1401, 1411, and 1412 of the Patient Protection and Affordable Care Act (PPACA) and 45 CFR part 155 subpart D, an Exchange makes an advance determination of tax credit eligibility for individuals who enroll in QHP coverage through the Exchange and seek financial assistance. Using information available at the time of enrollment, the Exchange determines whether the individual meets the income and other requirements for advance payments and the amount of the advance payments that can be used to pay premiums. Advance payments are made periodically under section 1412 of the PPACA to the issuer of the QHP in which the individual enrolls. Section 1402 of the PPACA provides for the reduction of cost sharing for certain individuals enrolled in a QHP through an Exchange, and section 1412 of the PPACA provides for the advance payment of these reductions to issuers. The statute directs issuers to reduce cost sharing for essential health benefits for individuals with household incomes between 100 and 400 percent of the Federal poverty level (FPL) who are enrolled in a silver level QHP through an individual market Exchange and are eligible for advance payments of the premium tax credit. Until January 2016, HHS collected data required to meet these statutory requirements via a manual system in which issuers submitted data. HHS now has an automated system that does not require issuer data submission for FFE issuers. The data collection has been used by HHS to make payments or collect charges from SBE issuers under the following programs: Advance payments of the premium tax credit, advanced cost-sharing reductions, and Exchange user fees. The workbook template was used to make payments in January 2014 and will continue for issuers in states transitioning to a State-Based Exchange, as may be required based on HHS's operational progress. Form Number: CMS-10515 (OMB Control Number: 0938-1217); Frequency: Occasionally; Affected Public: Private Sector—Business or other for-profits and not-for-profit institutions; Number of Respondents: 50; Total Annual Responses: 600; Total Annual Hours: 3,051. (For policy questions regarding this collection contact Christelle Jang at 410-786-8438.)

Description: The EDE provides a centralized, secure system for authorized users in state child support agencies to electronically exchange child support and spousal support case information with other state child support agencies. EDE benefits state child support agencies by reducing delays, costs, and barriers associated with interstate case processing, increasing state collections, improving document security, standardizing data sharing, increasing state participation, and improving case processing, resulting in better overall child and spousal support outcomes. OCSE made minor updates to the Portal screens to enhance functionality.

Respondents: State Child Support Agencies.

Annual Burden Estimates:

Description: The CCWIS information collection includes two components:

• The Automated Function List update required pursuant to section 1355.52(i)(2); and

• The Data Quality Plan update required pursuant to section 1355.52(d)(5).

The CCWIS regulations require updates of this information to confirm that the project meets CCWIS requirements and that project costs are appropriately allocated to benefiting programs.

Respondents: Title IV-E agencies under the Social Security Act.

Estimated Annual Burden Hours: 2,750.

Authority: 42 U.S.C. 620 et seq., 42 U.S.C. 670 et seq., 42 U.S.C. 1301 and 1302.

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

This information collection helps support implementation of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Pub. L. 107-250) and FDA's Medical Device User Fee program. Current authorization for medical device user fees will be in place from October 1, 2017, until September 30, 2022.

Section 738(d)(2)(A) and (e)(2)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(d)(2)(A) and (e)(2)(A)) define a “small business” as an entity that reported $100 million or less of gross receipts or sales in its most recent Federal income tax return, including such returns of its affiliates, partners, and parent firms. If a firm's gross receipts or sales are no more than $30 million (including all affiliates, partners, and parent firms), they will also qualify for a waiver of the fee for their first (ever) premarket application, product development protocol, biological licensing application, or premarket report. A “small business” is eligible for reduced or waived fees. If an applicant does not provide information to FDA demonstrating to FDA's satisfaction that the applicant is a small business, the applicant must pay the standard (full) fee for any application it submits.

Forms FDA 3602 (“MDUFA Small Business Certification Request for a Business Headquartered in the United States”) and 3602A (“MDUFA Foreign Small Business Certification Request for a Business Headquartered Outside the United States”) are submitted to FDA to demonstrate that an applicant qualifies as a MDUFA small business. The guidance “Medical Device User Fee Small Business Qualification and Certification; Guidance for Industry, Food and Drug Administration Staff and Foreign Governments”  1 describes the process by which a business may request certification as a small business and the criteria FDA will use to decide whether an entity qualifies as a MDUFA small business and is eligible for a reduction in user fees.

In the Federal Register of December 23, 2021 (86 FR 72983), we published a 60-day notice requesting public comment on the proposed collection of information. One comment was received, however it did not respond to the functional elements solicited in our 60-day notice or suggest a revision to our burden estimate.

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

Our estimated burden is based on the number of applications received in the last few years and includes the time we assume necessary to prepare and submit required information. Based on our experience with Forms FDA 3602 and 3602A, we assume it will take respondents 1 hour to complete either form. We have adjusted our estimated “No. of Respondents” to better reflect recent submission volume. This adjustment results in a 2,500-hour decrease to the information collection.

When enacted in 1938, the Federal Food, Drug, and Cosmetic Act (FD&C Act) required that “new drugs” (21 U.S.C. 321(p)) be approved for safety by FDA before they could legally be sold in interstate commerce. Between 1938 and 1962, if a drug obtained approval, FDA considered drugs that were IRS (see 21 CFR 310.6(b)(1)) to the approved drug to be covered by that approval and allowed those IRS drugs to be marketed without independent approval.

In 1962, Congress amended the FD&C Act to require that new drugs be proven effective for their labeled indications, as well as safe, in order to obtain FDA approval. This amendment also required FDA to conduct a retrospective evaluation of the effectiveness of the drug products that FDA had approved as safe between 1938 and 1962. FDA contracted with the National Academy of Sciences/National Research Council (NAS/NRC) to make an initial evaluation of the effectiveness of over 3,400 products that had been approved only for safety between 1938 and 1962. The NAS/NRC reports for these drug products were submitted to FDA in the late 1960s and early 1970s. The Agency reviewed and reevaluated the reports and published its findings in Federal Register notices. FDA's administrative implementation of the NAS/NRC reports was called the Drug Efficacy Study Implementation (DESI). DESI covered the approximately 3,400 products specifically reviewed by the NAS/NRC, as well as the even larger number of IRS products that entered the market without FDA approval.

All drugs covered by the DESI review are “new drugs” under the FD&C Act. If FDA's final DESI determination classifies a drug product as lacking substantial evidence of effectiveness for one or more indications, that drug product and those IRS to it may no longer be marketed for such indications and are subject to enforcement action as unapproved new drugs. If FDA's final DESI determination classifies the drug product as effective for one or more of its labeled indications, the drug can be marketed for such indications, provided it is the subject of an application approved for safety and effectiveness. Sponsors of drug products that have been found to be effective for one or more indications through the DESI process may rely on FDA's effectiveness determinations, but typically must update their labeling to conform to the indication(s) found to be effective by FDA and include any additional safety information required by FDA. Those drug products with NDAs approved before 1962 for safety therefore require approved supplements to their original applications if one or more indications are found to be effective under DESI; IRS drug products require an approved NDA or ANDA, as appropriate. Furthermore, labeling for drug products classified as effective may contain only those indications for which the review found the product effective unless the firm marketing the product has received an approval for the additional indication(s).

In a Federal Register notice published on June 22, 1971 (36 FR 11875) (1971 Federal Register notice), FDA announced its evaluation of reports received from NAS/NRC under DESI 10837, regarding anticholinergic drug products containing the following active ingredients: Prochlorperazine maleate and isopropamide iodide; oxyphencyclimine hydrochloride and meprobamate; oxyphencyclimine hydrochloride and hydroxyzine hydrochloride; tridihexethyl chloride and meprobamate; and propantheline bromide and thiopropazate hydrochloride. The drugs were found to be possibly effective as adjunctive therapy in peptic ulcer and in the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis, functional gastrointestinal disorders); functional diarrhea; drug induced diarrhea; ulcerative colitis, and urinary bladder spasm, and urethral spasm ( i.e., smooth muscle spasm). In addition, oxyphencyclimine and meprobamate preparations were found to be possibly effective for dysmenorrhea. These drugs were found to lack substantial evidence of effectiveness for their other labeled indications.

In a Federal Register notice published November 11, 1975 (40 FR 52644) (1975 Federal Register notice), the Agency explained that several of the products listed in the 1971 Federal Register notice may remain on the market while clinical studies were being conducted to determine their efficacy for the indications rated as “possibly effective,” because they were widely used in the treatment of peptic ulcer disease and functional bowel syndrome and were perceived as important and useful tools of therapy by many gastroenterologists and general practitioners (40 FR 52644 at 52648). In addition to the products from the 1971 Federal Register notice, the 1975 Federal Register notice included several products, among them Librax Capsules, NDA 12-750, containing clidinium bromide and chlordiazepoxide, now manufactured by Bausch Health Companies, Inc. (Bausch), that had been the subject of safety-only applications approved before 1962 and that had not been reviewed by NAS/NRC. Librax Capsules was included in the 1975 Federal Register notice notwithstanding the Stipulation for Dismissal in Hoffman-La Roche, Inc. v. Richardson, et. al., Civil Action 11-73 (D.N.J. August 2, 1973), discussed below. The 1975 Federal Register notice set forth a timetable for conducting clinical efficacy studies for drug products subject to the notice. In a Federal Register notice published June 20, 1978 (43 FR 26490) (1978 Federal Register notice), FDA announced a change in its previous policy for testing and marketing of the drugs that were subject of the November 11, 1975, notice ( e.g., Librax), including an extension of deadline for completion of the studies for 1 year.

In a Federal Register notice published January 16, 1981(46 FR 3977) (1981 Federal Register notice), FDA announced its evaluation of study reports received in response to the 1975 Federal Register notice. FDA concluded that there was a lack of substantial evidence demonstrating the effectiveness of the drugs listed in the 1975 notice, proposed to withdraw approval of the new drug applications, and offered an opportunity for hearing to manufacturers of the drugs listed in the notice, as well as to the manufacturers of IRS products.

As set forth in a Federal Register notice published July 24, 2012 (77 FR 43337) (2012 Federal Register notice), several companies submitted timely hearing requests in response to the 1981 Federal Register notice, but the only such request that had not been withdrawn as of July 2012, was the request regarding Librax Capsules, filed by Roche Laboratories, manufacturer of Librax Capsules in 1981 (77 FR 43337 at 43341). In response to the 2012 Federal Register notice, Valeant Pharmaceuticals North America LLC (now Bausch) affirmed the hearing request regarding Librax Capsules by letter dated August 22, 2012.

On May 23, 2016, FDA posted a Notice to Docket 1975-N-0336, explaining that Librax is not subject to review under DESI because a new drug application for Librax was approved by the Agency on September 1, 1966, and at that time the Agency determined that Librax was safe and effective for the indications set forth in its labeling, (consistent with the Stipulation for Dismissal in Hoffman-La Roche, Inc. v. Richardson, et al., Civil Action 11-73 (D.N.J. August 2, 1973)). On June 2, 2016, Valeant responded by withdrawing its hearing request.

There are no longer outstanding hearing requests pertaining to drug products containing an anticholinergic or antispasmodic in combination with a sedative, and single-entity antispasmodic drug products, in oral dosage form under Docket No. FDA-1975-N-0336, DESI 10837. Shipment in interstate commerce of any drug product identified in this docket under DESI 10837, or any IRS product, that is not the subject of an approved NDA or ANDA is unlawful as of the applicable date of this notice (see DATES ). Any person who wishes to determine whether a specific product is covered by this notice should write to Jeffrey Trunzo (see FOR FURTHER INFORMATION CONTACT ). Firms should be aware that, after the applicable date of this notice (see DATES ), FDA intends to take enforcement action without further notice against any firm that manufactures or ships in interstate commerce any unapproved product covered by this notice.

Firms must notify the Agency of certain product discontinuations in writing under section 506C(a) of the FD&C Act (21 U.S.C. 356c) (see https://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm142398.htm ). Some firms may have previously discontinued manufacturing or distributing products covered by this notice without discontinuing the listing as required under section 510(j) of the FD&C Act (21 U.S.C. 360(j)). Other firms may discontinue manufacturing or distributing listed products in response to this notice. All firms are required to electronically update the listing of their products under 510(j) of the FD&C Act to reflect discontinuation of unapproved products covered by this notice (21 CFR 207.57(b)). Questions on electronic drug listing updates should be sent to eDRLS@fda.hhs.gov. In addition to the required update, firms can also notify the Agency of product discontinuation by sending a letter, signed by the firm's chief executive officer and fully identifying the discontinued product(s), including the product National Drug Code (NDC) number(s), and stating that the manufacturing and/or distribution of the product(s) have been discontinued. The letter should be sent electronically to Jeffrey Trunzo (see FOR FURTHER INFORMATION CONTACT ). FDA plans to rely on its existing records, including its drug listing records, the results of any future inspections, or other available information, when it identifies violative products for enforcement action.

FDA cautions firms against reformulating products and marketing under the same name or substantially the same name (including a new name that contains the old name). Reformulated products marketed under a name previously identified with a different active ingredient or combinations of active ingredients have the potential to confuse healthcare practitioners and harm patients.

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 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.

Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) authorizes FDA to conduct research relating to health information. Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to conduct research relating to drugs and other FDA-regulated products in carrying out the provisions of the FD&C Act.

The Office of Prescription Drug Promotion's (OPDP) mission is to protect the public health by helping to ensure that prescription drug promotion is truthful, balanced, and accurately communicated. OPDP's research program provides scientific evidence to help ensure that our policies related to prescription drug promotion will have the greatest benefit to public health. Toward that end, we have consistently conducted research to evaluate the aspects of prescription drug promotion that are most central to our mission. Our research focuses in particular on three main topic areas: Advertising features, including content and format; target populations; and research quality. Through the evaluation of advertising features, we assess how elements such as graphics, format, and disease and product characteristics impact the communication and understanding of prescription drug risks and benefits. Focusing on target populations allows us to evaluate how understanding of prescription drug risks and benefits may vary as a function of audience, and our focus on research quality aims at maximizing the quality of research data through analytical methodology development and investigation of sampling and response issues. This study will inform the first and second topic areas, advertising features and target populations.

Because we recognize that the strength of data and the confidence in the robust nature of the findings are improved by using the results of multiple converging studies, we continue to develop evidence to inform our thinking. We evaluate the results from our studies within the broader context of research and findings from other sources, and this larger body of knowledge collectively informs our policies as well as our research program. Our research is documented on our home page, which can be found at: https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research. The website includes links to the latest Federal Register notices and peer-reviewed publications produced by our office.

The proposed research examines the relative importance of prescription drug product information such as prescription drug efficacy, risk, adherence, and patient preference claims in two medical conditions (type 2 diabetes and psoriasis) in consumer and physician samples. When confronted with an important decision, people tend to make choices that reflect a series of tradeoffs between certain desirable and undesirable attributes of a product, service, or experience. Pharmaceutical manufacturers provide information about prescription drug products, including side effects, contraindications, and effectiveness through product labeling and promotional materials (21 CFR 202.1(e)). The treatment preferences of diagnosed consumers and treating physicians have been shown to be influenced by certain characteristics, such as the perceived drug's impact on quality of life, complexity of dosage regimens, mode of administration, cost to family and self, and marketing claims unrelated to medicinal properties (Refs. 1 to 5). Although diagnosed consumers may weigh the risks, benefits, or other salient characteristics of prescription drug products differently than physicians, little research directly compares the treatment preferences of these two groups (Ref. 6). Understanding the tradeoffs among drug product characteristics diagnosed consumers make—and how the tradeoffs could potentially differ from the tradeoffs made by physicians—will provide valuable insight into the relevance and impact of various product attributes and promotional claims on informed choices and treatment decisions.

We intend to examine these tradeoffs using a choice-based conjoint analysis, also known as a discrete choice experiment. Conjoint analysis is a broad class of survey-based techniques used to estimate how attractive or influential different features of choice options or product attributes are in determining purchase behavior or treatment choices (Ref. 7). Conjoint analysis can be used to examine the joint effects and tradeoffs of multiple variables or product attributes on decisions. A choice-based conjoint analysis is based on the principle that products are composed of a set of attributes, and each attribute can be described using a finite number of levels. In the proposed research, participants will be shown a carefully designed sequence of choice tasks containing up to five hypothetical product attributes—in this case, profiles describing fictitious prescription drug products for either type 2 diabetes or psoriasis. Using data from the choices that participants make across these tasks, we can use statistical techniques to draw inferences about the relative value they place on different product attributes, estimate the relative importance of different attributes, explore the tradeoffs that consumers and physicians are willing to make to avoid or accept specific attribute levels, and compare the preferences of these two groups (Ref. 8).

We estimate that participation in the study will take approximately 20 minutes. Adult participants aged 18 years or older will be recruited by email through an internet panel, and participant eligibility will be determined with a screener at the beginning of the online survey. The consumer sample will consist of adults who self-report as having been diagnosed by a healthcare provider with either psoriasis or type 2 diabetes. For the consumer sample, we will exclude individuals who work in healthcare settings because their knowledge and experiences may not reflect those of the average consumer. The physician sample will consist of primary care physicians and specialists who report treating patients with psoriasis or type 2 diabetes. For the physician sample, we will exclude individuals who spend less than 50 percent of their time on direct patient care. Department of Health and Human Services employees and individuals who work in the marketing, advertising, or pharmaceutical industries will be excluded from both respondent groups. Respondents will receive a survey invitation with a unique password protected link. All panel members are recruited following a double opt-in process. Sample sizes were estimated by combining approaches for conjoint analysis suggested by Orme (Ref. 9) and Johnson et al. (Ref. 10).

The target sample size for the main study is 800 physicians and 800 consumers, with half of each cohort focusing on treatments for psoriasis and the other half focusing on treatments for type 2 diabetes. Prior to conducting the main study, we will conduct at least one pretest. If the first pretest reveals that changes to the measurement instruments, stimuli, or procedures are required, a second pretest will be conducted with revised materials. The target sample size for each wave of pretests is 60 physicians and 60 consumers.

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

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

This information collection helps support implementation of the Department of Health and Human Services' “PHS Guideline on Infectious Disease Issues in Xenotransplantation” dated January 19, 2001, available at: https://www.fda.gov/media/73803/download. FDA is authorized to collect this information under sections 351 and 361 of the PHS Act (42 U.S.C. 262 and 264) and provisions of the Federal Food, Drug, and Cosmetic Act that apply to drugs (21 U.S.C. 321 et seq. ). The guideline was developed by the PHS to identify general principles for the prevention and control of infectious diseases associated with xenotransplantation that may pose a risk to public health. The PHS guideline recommends procedures to diminish the risk of transmission of infectious agents to the xenotransplantation product recipient and to the general public. The PHS guideline is intended to address public health issues raised by xenotransplantation, through identification of general principles of prevention and control of infectious diseases associated with xenotransplantation that may pose a hazard to the public health. The collection of information described in this guideline is intended to provide general guidance on the following topics: (1) The development of xenotransplantation clinical protocols; (2) the preparation of submissions to FDA; and (3) the conduct of xenotransplantation clinical trials. Also, the collection of information will help ensure that the sponsor maintains important information in a cross-referenced system that links the relevant records of the xenotransplantation product recipient, xenotransplantation product, source animal(s), animal procurement center, and significant nosocomial exposures. The PHS guideline also describes an occupational health service program for the protection of health care workers involved in xenotransplantation procedures, caring for xenotransplantation product recipients, and performing associated laboratory testing. The PHS guideline is intended to protect the public health and to help ensure the safety of using xenotransplantation products in humans by preventing the introduction, transmission, and spread of infectious diseases associated with xenotransplantation.

The PHS guideline also recommends that certain specimens and records be maintained for 50 years beyond the date of the xenotransplantation. These include: (1) Records linking each xenotransplantation product recipient with relevant health records of the source animal, herd or colony, and the specific organ, tissue, or cell type included in or used in the manufacture of the product (3.2.7.1); (2) aliquots of serum samples from randomly selected animal and specific disease investigations (3.4.3.1); (3) source animal biological specimens designated for PHS use (3.7.1); (4) animal health records (3.7.2), including necropsy results (3.6.4); and (5) recipients' biological specimens (4.1.2). The retention period is intended to assist health care practitioners and officials in surveillance and in tracking the source of an infection, disease, or illness that might emerge in the recipient, the source animal, or the animal herd or colony after a xenotransplantation.

The recommendation for maintaining records for 50 years is based on clinical experience with several human viruses, such as human cytomegalovirus and BK polyoma virus, which have presented problems in human-to-human transplantation and are therefore thought to share certain characteristics with viruses that may pose potential risks in xenotransplantation. These characteristics include long latency periods and the ability to establish persistent infections. Several also share the possibility of transmission among individuals through intimate contact with human body fluids. Human immunodeficiency virus (HIV) and human T-lymphotropic virus are human retroviruses. Retroviruses contain ribonucleic acid that is reverse-transcribed into deoxyribonucleic acid (DNA) using an enzyme provided by the virus and the human cell machinery. That viral DNA can then be integrated into the human cellular DNA. Both viruses establish persistent infections and have long latency periods before the onset of disease, 10 years and 40 to 60 years, respectively. The human hepatitis viruses are not retroviruses, but several share with HIV the characteristic that they can be transmitted through body fluids, can establish persistent infections, and have long latency periods, e.g., approximately 30 years for hepatitis C.

In addition, the PHS guideline recommends that a record system be developed that allows easy, accurate, and rapid linkage of information among the specimen archive, the recipient's medical records, and the records of the source animal for 50 years. The development of such a record system is a one-time burden. Such a system is intended to cross-reference and locate relevant records of recipients, products, source animals, animal procurement centers, and significant nosocomial exposures.

Respondents to this collection of information are the sponsors of clinical studies of investigational xenotransplantation products under investigational new drug applications (INDs) and xenotransplantation product procurement centers, referred to as source animal facilities. There are an estimated three respondents who are sponsors of INDs that include protocols for xenotransplantation in humans and five clinical centers doing xenotransplantation procedures. Other respondents for this collection of information are an estimated four source animal facilities which provide source xenotransplantation product material to sponsors for use in human xenotransplantation procedures. These four source animal facilities keep medical records of the herds/colonies as well as the medical records of the individual source animal(s). The burden estimates are based on FDA's records of xenotransplantation-related INDs and estimates of time required to complete the various reporting, recordkeeping, and third-party disclosure tasks described in the PHS guideline.

In the Federal Register of October 22, 2021 (86 FR 58666), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received one comment letter, which contained multiple comments, in response to the notice. Several comments (recommendations for selection of xenograft recipients, hospital personnel and care providers, and handling of donor and recipient tissue) were not responsive to the four information collection topics solicited in the 60-day notice and therefore will not be addressed in this notice.

(Comment 1) One comment in the letter was supportive of expanded collection and testing of blood samples from xenograft recipients, their immediate family, close social/sexual contacts, as well as other persons at risk of exposure to infection.

(Response) We agree with the utility of blood sampling and testing to track the source of any long-term developing infections as a result of xenotransplantation. We have considered the comment and have determined that the comment does not present information that would warrant substantive changes to the guideline at this time.

(Comment 2) One comment in the letter recommended shortening the 50-year retention period for frozen samples of serum, cells, and tissues recommended by the PHS guideline. Among other reasons, the comment argued that transplant recipients generally manifest either donor-derived or opportunistic infections in the first-year post-transplantation; malignancies and uncommon infections may manifest later, but generally within 5-10 years; and patient survival post-organ transplantation is generally less than 20 years. The comment concluded that storage of samples beyond 20 years for initial studies should not be necessary.

(Response) We have considered the comment and have determined that the comment does not present information that would warrant substantive changes to the guideline at this time.

(Comment 3) One comment in the letter stated that the sponsor of the clinical trial or the hospital in which the trial is carried out should be relieved of the responsibility to store their records and samples. The comment argued that ongoing data and specimen collection, as well as the maintenance of repositories represents a significant burden on both sponsors and transplant programs with resultant significant cost and hardship that could deter xenotransplant progress. The comment concluded that storage of records and samples should be the responsibility of a recognized government authority or institution or an FDA-designated organization. The comment recommended the creation of a central repository for both data and specimen collection run by, or under contract with, the Federal government.

(Response) The comment did not provide any data that would support a change to the burden estimate in the 60-day notice. Thus, FDA has not changed the burden estimate in table 1 of this document. We have considered the comment and have determined that the comment does not present information that would warrant substantive changes to the guideline at this time.

FDA is requesting an extension of OMB approval for the following reporting, recordkeeping and third-party disclosure recommendations in the PHS guideline:

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

Because of the potential risk for cross-species transmission of pathogenic persistent virus, the guideline recommends that health records be retained for 50 years. Since these records are medical records, the retention of such records for up to 50 years is not information subject to the PRA (5 CFR 1320.3(h)(5)). Also, because of the limited number of clinical studies with small patient populations, the number of records is expected to be insignificant at this time. Information collections in this guideline not included in tables 1 through 6 can be found under existing regulations and approved under the OMB control numbers as follows: (1) “Current Good Manufacturing Practice for Finished Pharmaceuticals,” 21 CFR 211.1 through 211.208, approved under OMB control number 0910-0139; (2) “Investigational New Drug Application,” 21 CFR 312.1 through 312.160, approved under OMB control number 0910-0014; and (3) information included in a biologics license application, 21 CFR 601.2, approved under OMB control number 0910-0338. (Although it is possible that a xenotransplantation product may not be regulated as a biological product ( e.g., it may be regulated as a medical device), FDA believes, based on its knowledge and experience with xenotransplantation, that any xenotransplantation product subject to FDA regulation within the next 3 years will most likely be regulated as a biological product.). However, FDA recognized that some of the information collections go beyond approved collections; assessments for these burdens are included in tables 1 through 6.

In table 7, FDA identifies those collection of information activities that are already encompassed by existing regulations or are consistent with voluntary standards which reflect industry's usual and customary business practice.

Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate other than to adjust total burden hours by one hour, from 60 to 59 total burden hours, to address an inadvertent error in disclosure burden in the previous submissions to OMB.

The applicants listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process described in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling.

Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of May 25, 2022. Approval of each entire application is withdrawn, including any strengths and dosage forms inadvertently missing from the table. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on May 25, 2022 may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first.

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

Sections 801 and 802 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 381 and 382) charge the Secretary of Health and Human Services, through FDA, with the responsibility of helping to ensure that exports of unapproved new drugs, biologics, devices, animal drugs, food, cosmetics, and tobacco products that are not to be sold in the United States meet the requirements of the country to which the product is to be exported. The respondents to this information collection are exporters who have notified FDA of their intent to export unapproved products that may not be sold or offered for sale in domestic commerce in the United States as allowed under section 801(e) of the FD&C Act. In general, the notification identifies the product being exported ( e.g., name, description, and in some cases, country of destination) and specifies where the notifications were sent. These notifications are sent only for an initial export. Subsequent exports of the same product to the same destination or to certain countries identified in section 802(b) of the FD&C Act would not result in a notification to FDA.

Respondents to the information collection are exporters of products that may not be sold in the United States and are regulated by FDA's Center for Drug Evaluation and Research (CDER); Center for Biologics Evaluation and Research (CBER); Center for Devices and Radiological Health (CDRH); Center for Veterinary Medicine (CVM); Center for Food Safety and Applied Nutrition (CFSAN); and Center for Tobacco Products. Respondents to this collection of information maintain records demonstrating their compliance with the requirements in 21 CFR 1.101.

In the Federal Register of January 25, 2022 (87 FR 3811), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

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

Based on a review of Agency data, we decreased our estimate by 24,251 burden hours. This decrease reflects an overall downward trend in the number of export certification requests across programs and commodities. The estimate for tobacco products remains steady.

This proposed information collection was previously published in the Federal Register on February 14, 2022, page 8267 (87 FR 8267) and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

The National Institute on Drug Abuse (NIDA), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

Proposed Collection: The International Research Fellowship Award Program of the National Institute on Drug Abuse (NIDA), 0925-0733, expiration date 07/31/2022, EXTENSION, National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH).

Need And Use of Information Collection: These programs offer grants and traineeships necessary for growing the biomedical researcher workforce, and the diversity in this workforce. The application forms collect information of applicants for selecting those that would benefit most effectively from the programs. NIDA is requesting approval from OMB for application forms to be used by these programs that will recruit pre-college through post-doctoral underrepresented individuals and individuals of special populations into the research programs of the Institute for research training and research development, for forging mentor/mentee relationships and networking between newly funded underrepresented researchers and experienced investigators funded by NIDA; and for a fellowship program to train new researchers, and support experienced researchers of other nations, in research to advance the biomedical and behavioral science of drug abuse and addiction while fostering multinational research in this disease area. The application forms will be web-based.

OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total annualized burden hours are 33.

Comments

Written comments and suggestions from the public and affected agencies concerning the proposed collection of information should address one or more of the following four points:

(1) Evaluate 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;

(2) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(3) Enhance the quality, utility, and clarity of the information to be collected; and

(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

(1) Type of Information Collection: Revision of a Currently Approved Collection.

(2) Title of the Form/Collection: Designation of Attorney in Fact/Revocation of Attorney in Fact.

(3) Agency form number, if any, and the applicable component of the Department of Homeland Security sponsoring the collection: Form I-312/I-312A; U.S. Immigration and Customs Enforcement.

(4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: State, Local, or Tribal Government. Section § 103.6, the Immigration and Nationality Act (INA), provides for the posting of surety or cash bonds. All bonds posted in immigration cases shall be executed on Form I-352, Immigration Bond, and secured with some form of collateral by an Obligor. In the case of a cash bond, the Obligor will deposit with U.S. Immigration and Customs Enforcement (ICE) the face value of the bond. The Obligor can designate a third party as an Attorney in Fact to accept on their behalf the return of the collateral security deposited to secure the surety bond upon cancellation of the bond or performance of the Obligor. The Form I- 312, Designation of Attorney in Fact, is the instrument used by the Obligor to officially designate their Attorney in Fact. Upon receipt of a properly executed Form I-312, ICE Financial Operations will remit to the Attorney in Fact the principal and interest on the security deposit in the event of a bond cancellation, or the interest on the security deposit in the event of a bond breach. Immigration bonds might remain in place for years, and Obligors might choose to appoint a new Attorney in Fact as circumstances change. To ensure that ICE Financial Operations properly executes its fiduciary duties to the Obligor under the Form I-352 bond contract, and exercises due diligence in ensuring that remittances are made to the proper person, ICE uses Form I- 312A as the document by which the Obligor could expressly indicate that a previously valid Form I-312 Attorney in Fact designation had been revoked. The requested revisions are specific to the instructions concerning obligor requirements and the attorney's authority to perform acts necessary to receive proceeds of the bond. There are revisions to the I-312 instructions. The revisions relate to the obligor requirements and to the attorney's authority to perform acts necessary to received bond proceeds.

(5) An estimate of the total number of respondents and the time to respond: ICE estimates a total of 193 responses at 1 hour (60 minutes) per response.

(6) An estimate of the total public burden (in hours) associated with the collection: The total estimated annual hour burden is 193 hours.

(7) An estimate of the total public burden (in cost) associated with the collections: $6,370.

We invite review and comment from the public and local, State, Tribal, and Federal agencies on applications we have received for permits to conduct certain activities with endangered and threatened species under section 10(a)(1)(A) of the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq. ), and our regulations in the Code of Federal Regulations (CFR) at 50 CFR part 17. With some exceptions, the ESA prohibits take of listed species unless a Federal permit is issued that authorizes such take. The ESA's definition of “take” includes hunting, shooting, harming, wounding, or killing, and also such activities as pursuing, harassing, trapping, capturing, or collecting.

A recovery permit issued by us under section 10(a)(1)(A) of the ESA authorizes the permittee to take endangered or threatened species while engaging in activities that are conducted for scientific purposes that promote recovery of species or for enhancement of propagation or survival of species. These activities often include the capture and collection of species, which would result in prohibited take if a permit were not issued. Our regulations implementing section 10(a)(1)(A) for these permits are found at 50 CFR 17.22 for endangered wildlife species, 50 CFR 17.32 for threatened wildlife species, 50 CFR 17.62 for endangered plant species, and 50 CFR 17.72 for threatened plant species.

Proposed activities in the following permit requests are for the recovery and enhancement of propagation or survival of the species in the wild. The ESA requires that we invite public comment before issuing these permits. Accordingly, we invite local, State, Tribal, and Federal agencies and the public to submit written data, views, or arguments with respect to these applications. The comments and recommendations that will be most useful and likely to influence agency decisions are those supported by quantitative information or studies.

Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

We have received an application from 8minute Solar Energy (applicant) for an incidental take permit under the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq. ). The application addresses the potential take of the federally threatened desert tortoise, incidental to otherwise lawful activities at the Bellefield Solar Energy Project (project), as described in the applicant's draft habitat conservation plan. The proposed project would be located east of the town of Mojave in Kern County, California.

Section 9 of the ESA (16 U.S.C. 1538) and Federal regulations promulgated pursuant to section 4(d) of the ESA (16 U.S.C. 1533) prohibit the take of endangered and threatened animals without special exemption. Under section 10(a)(1)(B) of the ESA (16 U.S.C. 1539), we may issue permits to authorize take of listed fish and wildlife species that is incidental to, and not the purpose of, carrying out an otherwise lawful activity. Regulations governing permits for endangered and threatened species are set forth in title 50 of the Code of Federal Regulations (CFR) at part 17, sections 17.22 and 17.32.

The National Environmental Policy Act (NEPA; 42 U.S.C. 4321 et seq. ) requires Federal agencies to analyze their proposed actions to determine whether the actions may significantly affect the human environment. In the NEPA analysis, the Federal agency will identify the effects, as well as possible mitigation for effects on environmental resources, that could occur with the implementation of the proposed action and alternatives. The Federal action in this case is the Service's proposed issuance of an incidental take permit for the federally threatened desert tortoise.

The applicant has submitted a draft habitat conservation plan that describes the activities covered by the permit, such as the construction of the solar field and generator tie-in line. To minimize the risk of incidental take, the applicant would employ qualified biologists to translocate desert tortoises to a safe location off site. The conservation plan also includes adaptive management to allow for maintaining the protection of desert tortoises if necessary. To mitigate the impact of the incidental take, the applicant proposes to fund the enhancement of desert tortoise habitat within a retired grazing allotment on lands managed by the Bureau of Land Management.

The draft conservation plan and the draft environmental assessment consider alternatives to the proposed action, including a no action alternative.

The Service prepared a draft environmental assessment to evaluate the impacts of issuing the proposed incidental take permit on the human environment, consistent with the purpose and goals of NEPA and pursuant to the Council on Environmental Quality's implementing NEPA regulations at 40 CFR parts 1500-1508. Additionally, the draft environmental assessment was prepared consistent with the Department of the Interior NEPA regulations (43 CFR part 46); longstanding Federal judicial and regulatory interpretations; and Administration priorities and policies, including Secretary's Order No. 3399, which requires bureaus and offices to use “the same application or level of NEPA that would have been applied to a proposed action before the 2020 Rule went into effect.”

If you wish to comment on the draft conservation plan and draft environmental assessment, you may submit comments by one of the methods in ADDRESSES .

You may submit comments by one of the methods shown under ADDRESSES . All comments and materials we receive in response to this request will become part of the decision record associated with this action. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment, including your personal identifying information, may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

We issue this notice pursuant to section 10(c) of the ESA (16 U.S.C. 1539) and its implementing regulations (50 CFR 17.22), and NEPA (42 U.S.C. 4321 et seq. ) and its implementing regulations (40 CFR 1506.6 and 43 CFR 46.305).

We invite the public and local, State, Tribal, and Federal agencies to comment on these applications. Before issuing any of the requested permits, we will take into consideration any information that we receive during the public comment period.

You may submit your comments and materials by one of the methods in ADDRESSES . We will not consider comments sent by email or fax, or to an address not in ADDRESSES . We will not consider or include in our administrative record comments we receive after the close of the comment period (see DATES ). When submitting comments, please specify the name of the applicant and the permit number at the beginning of your comment. Provide sufficient information to allow us to authenticate any scientific or commercial data you include.

The comments and recommendations that will be most useful and likely to influence agency decisions are: (1) Those supported by quantitative information or studies; and (2) those that include citations to, and analyses of, the applicable laws and regulations.

You may view and comment on others' public comments at https://www.regulations.gov, unless our allowing so would violate the Privacy Act (5 U.S.C. 552a) or Freedom of Information Act (5 U.S.C. 552).

If you submit a comment at https://www.regulations.gov, your entire comment, including any personal identifying information, will be posted on the website. If you submit a hardcopy comment that includes personal identifying information, such as your address, phone number, or email address, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so. Moreover, all submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, will be made available for public disclosure in their entirety.

To help us carry out our conservation responsibilities for affected species, and in consideration of section 104(c) of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361 et seq. ), and section 112(4) of the Wild Bird Conservation Act of 1992 (WBCA; 16 U.S.C. 4901-4916), we invite public comments on permit applications before final action is taken. With some exceptions, these Acts prohibit certain activities with listed species unless Federal authorization is issued that allows such activities. Service regulations regarding permits for any activity otherwise prohibited by the MMPA with respect to any marine mammals are available in title 50 of the Code of Federal Regulations in part 18. Service regulations regarding permits for any activity otherwise prohibited by the WBCA with respect to any wild birds are available in title 50 of the Code of Federal Regulations in part 15.

Concurrent with publishing this notice in the Federal Register , we are forwarding copies of the marine mammal applications to the Marine Mammal Commission and the Committee of Scientific Advisors for their review.

We invite comments on the following applications.

The applicant requests to renew a permit to obtain samples of polar bears ( Ursus maritimus ) that have been legally harvested or were taken from the wild for the purpose of scientific research. This notification covers activities to be conducted by the applicant over a 5-year period.

The applicant requests to renew a permit to deploy transmitters and collect skin biopsies to monitor the movement, timing, behavior, and habitat use of walruses ( Odobenus rosmarus ) in the wild for the purpose of scientific research. This notification covers activities to be conducted by the applicant over a 5-year period.

The applicant requests a permit to import and maintain one male and one female captive born live walrus ( Odobenus rosmarus ) for the purpose of public display. This notification covers activities to be conducted once within a 1-year time frame.

The applicant requests to amend a permit to measure the oxygen consumption of two captive adult polar bears ( Ursus maritimus ) to inform data collected from wild polar bears on the energetic costs of swimming for the purpose of scientific research. This notification covers activities to be conducted by the applicant over a 5-year period.

The applicant wishes to amend the Cooperative Breeding Program CB042 to add the following new species: Wreathed hornbill ( Rhyticeros undulatus ), wrinkled hornbill ( Rhabdotorrhinus corrugatus ), rhinoceros hornbill ( Buceros rhinoceros ), and Indian hornbill ( Buceros bicornis ), and to increase the approved number of imports for the Papuan hornbill ( Rhyticeros plicatus ) and rufous hornbill ( Buceros hydrocorax ) to their already existing program.

After the comment period closes, we will make decisions regarding permit issuance. If we issue permits to any of the applicants listed in this notice, we will publish a notice in the Federal Register . You may locate the notice announcing the permit issuance by searching https://www.regulations.gov for the permit number listed above in this document. For example, to find information about the potential issuance of Permit No. 12345A, you would go to https://www.regulations.gov and search for “12345A”.

We issue this notice under the authority of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq. ), and its implementing regulations, and the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361 et seq. ), and its implementing regulations.

Under section 11 of the Indian Gaming Regulatory Act (IGRA), Public Law 100-497, 25 U.S.C. 2701 et seq., the Secretary of the Interior shall publish in the Federal Register notice of approved Tribal-State compacts for the purpose of engaging in Class III gaming activities on Indian lands. As required by 25 CFR 293.4, all compacts and amendments are subject to review and approval by the Secretary.

The Amendment provides for on-reservation remote and retail event wagering consistent with the Tribe's minimum internal control standards, contains several technical changes including removing obsolete language, and includes a forward-looking provision which positions the Tribe to offer state-wide hub and spoke event wagering if State law is changed to allow such gaming, another Tribe's compact with the State authorizes such gaming, and the Tribe's Compact is amended. The Amendment is approved.

I. General Information.

Award Ceiling: $75,000.

Award Floor: $25,000.

CFDA Number: 15.032.

Cost Sharing or Matching Requirement: No.

Number of Awards: 20 to 35.

Category: Business Development.

II. Number of Projects Funded. OIED anticipates awarding approximately 20 to 35 grants under this announcement ranging in value from approximately $25,000 to $75,000. The program can fund projects only one year at a time. OIED will use a competitive evaluation process for awarding based on criteria described in the Review and Selection Process Section of this notice. Only one application will be accepted from an eligible Tribe, and only one application will be accepted from an eligible Tribal Organization of that Tribe.

III. Background. The Office of the Assistant Secretary—Indian Affairs, through OIED, is soliciting proposals from federally recognized Tribes listed as Indian Entities Recognized by and Eligible to Receive Services from the United States Bureau of Indian Affairs at 87 FR 4636 (January 28, 2022) and Tribal Organizations eligible for NABDI grants. Indian Tribes are referred to using the term “Tribe” throughout this notice. Tribal Organization is defined by 25 U.S.C. 5304( l ). Consultants may include, but are not limited to universities and colleges, private consulting firms, and non-academic non-profit entities. The feasibility studies will help facilitate informed decision-making regarding Tribes' economic futures. Feasibility studies may concern the viability of an economic development project or business, or the practicality of a technology, that a Tribe may choose to pursue to explore how a current Tribal business or enterprises could recover and adapt to the challenges resulting from the COVID-19 pandemic. NABDI awards may be used to develop business plans for eligible applicant's goals for economic opportunity and recovery, such as the economic impacts of the COVID-19 pandemic. The OIED administers this program through its Division of Economic Development (DED).

The funding periods and amounts referenced in this solicitation are subject to the availability of non-recurring appropriation funds of the BIA budget at the time of award, as well as the Department of the Interior (DOI) and Indian Affairs priorities at the time of the award. Neither DOI nor Indian Affairs will be held responsible for proposal or application preparation costs. Publication of this solicitation does not obligate DOI or Indian Affairs to award any specific grant or to obligate all or any part of available funds. Future funding is subject to the availability of appropriations and cannot be guaranteed. DOI or Indian Affairs may cancel or withdraw this solicitation at any time.

IV. Eligibility for Funding. The Office of the Assistant Secretary—Indian Affairs, through OIED, is soliciting proposals from federally recognized Tribes listed as Indian Entities Recognized by and Eligible to Receive Services from the United States Bureau of Indian Affairs at 87 FR 4636 (January 28, 2022) and Tribal Organizations eligible for NABDI grants. Indian Tribes are referred to using the term “Tribe” throughout this notice. Tribal Organization is defined by 25 U.S.C. 5304( l ).

V. Who may Perform Feasibility Studies or Develop Business Plans Funded by NABDI Grants? The applicant determines who will conduct its feasibility study or business plan. An applicant has several choices, including but not limited to:

• Universities and colleges;

• Private consulting firms; or

• Non-academic, non-profit entities.

VI. Applicant Procurement Procedures. The applicant is subject to the procurement standards in 2 CFR 200.318 through 200.326. In accordance with 2 CFR 200.318, an applicant must use its own documented procurement procedures which reflect Tribal laws and regulations, provided that the procurements conform to applicable Federal law and standards.

VII. Limitations. NABDI grant funding must be expended in accordance with applicable statutory and regulatory requirements, including 2 CFR part 200. As part of the grant application review process, OIED may conduct a review of an applicant's prior OIED grant awards(s).

Applicants that are currently under BIA sanction Level 2 or higher resulting from non-compliance with the Single Audit Act are ineligible for a NABDI award. Applicants at Sanction Level 1 will be considered for funding.

Only one application will be accepted from an eligible Tribe, and only one application will be accepted from an eligible Tribal Organization of that Tribe. Applications should address one project and any submissions that contain multiple project proposals will not be considered. OIED will apply the same objective ranking criteria to each proposal.

The purpose of NABDI grants is to fund feasibility studies and business plans for proposed economic development projects, businesses, technologies and for businesses recovering from the effects of the COVID-19 pandemic. An application can request funding for a feasibility study or a business plan.

NABDI awards may not be used for:

• Establishing or operating a Tribal Office;

• Indirect costs or administrative costs as defined by the Federal Acquisition Regulation (FAR);

• Purchase of equipment that is used to develop the feasibility studies, such as computers, vehicles, field gear, etc. (however, leasing of this type of equipment for the purpose of developing feasibility studies is allowed);

• Creating Tribal jobs to complete the project. A NABDI grant is not intended to create temporary administrative jobs or supplement employment for Tribal members;

• Legal fees;

• Application fees associated with permitting;

• Training;

• Contract negotiation fees;

• Feasibility studies of energy, mineral, energy legal infrastructure, or broadband related projects, businesses, or technologies that are addressed by OIED's Energy and Mineral Development Program (EMDP), Tribal Energy Development Capacity (TEDC); and

• Any other activities not authorized by the grant award letter.

VIII. NABDI Application Guidance. All applications must be submitted in digital form to grants.gov. For instructions, see https://www.grants.gov/help/html/help/Applicants/HowToApplyForGrants.htm.

IX. Mandatory Components. The mandatory components, and forms identified below, must be included in the proposal package. Links to the mandatory forms can be found under the “Related Package” tab on the NABDI FY2022 grant opportunity page at www.grants.gov. Any information in the possession of the BIA or submitted to the BIA throughout the process, including final work product, constitutes government records and may be subject to disclosure to third parties under the Freedom of Information Act (FOIA), 5 U.S.C. 552, and the Department of the Interior's FOIA regulations at 43 CFR part 2, unless a FOIA exemption or exception applies, or other provisions of law protect the information. Following are the names of the required forms:

Cover Page: A Cover Page must be included in the application and contain the following:

• Category of Funding for the NABDI application.

• Proposal Title.

• Total Amount of funding requested from the Program.

• Full and Proper Name of the applicant organization.

• Statement confirming the proposed work will have the potential to reach the intended goals and objectives.

• Confirm active registration in SAM, attaching print-out from sam.gov to the cover page. See instructions and registration instructions in Appendix.

• Provide active enrollment in ASAP and your Recipient ID with the BIA. Allow 3-4 weeks to complete all steps of enrollment prior to submission deadline. The organization must be enrolled in ASAP with BIA, current enrollment with other federal agencies is not sufficient. See instructions and registration instructions in Appendix.

• Confirmation of other completed Mandatory Components identified in this section (SF-424, Project Abstract Summary, etc).

• Identification of partnerships such as Tribes, other Tribal Organizations or Entities.

Applicants are required complete the Application for Federal Assistance SF-424.

Please use a descriptive file name that includes tribal name and project description. For example: NABDISF424.Tribalname.Project. The SF-424 form requires the Congressional District number of the applicant, which can be found at https://www.house.gov/reprentatives/find-your-representative.

Cover Letter: A cover letter is not to exceed one (1) page that summarizes the interest and intent, complete with authorized signature(s) of organization leadership.

The first paragraph of the project narrative must include the title and basic description of the proposed feasibility study or business plan. The Project Narrative must not exceed 15 pages. Supplemental information such as letters of support, graphs, charts, maps, photographs and other graphic and/or other relevant information may be included in an appendix and not counted against the 15-page Project Narrative Limit. At a minimum, it should include:

• A technical description of the project and, if applicable, an explanation of how the proposed study or business plan would benefit the applicant and does not duplicate previous work;

• A description of the project objectives and goals;

• Deliverable products that the consultant is expected to generate, including interim deliverables (such as status reports and technical data to be obtained) and final deliverables (the feasibility study or business plan); and

• Resumes of key consultants and personnel to be retained, if available, and the names of subcontractors, if applicable. This information may be included as an attachment to the application and will not be counted towards the 15-page limitation.

• Please use a descriptive file name that includes tribal name and project description. For example: NABDINarrative.Tribalname.Project.

In addition, unless prohibited by tribal procurement procedures, please include a description of the consultant(s) the applicant wishes to retain, including the consultant's contact information, technical expertise, training, qualifications, and suitability to undertake the feasibility study. These documents may be included at the end of the Project Narrative and will not be counted toward the 15-page limitation.

Project Narratives are not judged based on their length. Please do not submit any attachments or documents beyond what is listed above, e.g., Tribal history, unrelated photos and maps.

Applicants are required to utilize the SF-424A for the budget submission. Please use a descriptive file name that includes tribal name and project description. For example: NABDIBudget.Tribalname.Project. The budget must identify the amount of grant funding requested and a comprehensive breakdown of all projected and anticipated expenditures, including contracted personnel fees, consulting fees (hourly or fixed), travel costs, data collection and analysis costs, computer rentals, report generation, drafting, advertising costs for a proposed project and other relevant project expenses, and their subcomponents.

• Travel costs should be itemized by airfare, vehicle rental, lodging, and per diem, based on the current Federal government per diem schedule.

• Data collection and analysis costs should be itemized in sufficient detail for the OIED review committee to evaluate the charges.

• Other expenses may include computer rental, report generation, drafting, and advertising costs for a proposed project.

Utilize the attachments form to include the Tribal resolution issued in the fiscal year of the grant application, authorizing the submission of a NABDI 2022 grant application. It must be signed by authorized Tribal representative(s). The Tribal resolution must also include a description of the feasibility study or business plan to be developed. An application submitted without a Tribal Resolution will be considered incomplete. The attachments form can also be used to include any other attachments related to the proposal.

Grantees will be required to have two individuals who work directly on the project attend an in-person annual DOI/OIED-sponsored grantee 3-day meeting in Washington, DC, during the year of the grant award. Applicants must include costs in the budget to cover this requirement. Travel costs must not exceed $6,000 per person. Applicants should follow their own travel policies to budget for this 3-day meeting. Additional funds for these expenses will not be available once grant is awarded. In the event the meeting is converted to a virtual meeting due to timing or COVID related issues, those funds may be repurposed in the grant.

Please make sure that the System for Award Management (SAM) number used to apply is active, not expired, with a current Unique Entity Identifier (UEI) number on the SF-424.

Please make sure an active Automated Standard Application for Payment (ASAP) number is provided. Applicants must have an ASAP number and be enrolled with the BIA to be eligible.

Please list counties where the project is located and congressional district number where the project will be located.

Applicants must include a critical information page that includes:

• Please use a descriptive file name that includes tribal name and identifies it is the critical information page (CIP). For example: NABDICIP.Tribalname.Project

• Project Manager's contact information including address, email, desk, and cell phone number;

• Please make sure the System for Award Management (SAM) number used to apply is active, not expired, with a current UEI number on the SF-424;

• Please make sure an active Automated Standard Application for Payment (ASAP) number is provided. Applicants must have an ASAP number for the BIA to be eligible;

• Please list the county(ies) where the project is located and congressional district number(s) where the project is located.

X. Incomplete Applications. Incomplete applications will not be accepted. Please ensure that all forms listed in the announcement are completed and submitted in grants.gov .

XI. Review and Selection Process. Upon receiving a NABDI application, OIED will determine whether the application is complete and that the proposed project does not duplicate or overlap previous or currently funded OIED technical assistance projects. Any proposal that is received after the date and time in the DATES section of this notice will not be reviewed.

The OIED Review Committee, comprised of OIED staff, staff from other Federal agencies, and subject matter experts, will evaluate the proposals against the ranking criteria. Proposals will be evaluated using the four ranking criteria listed below, with a maximum achievable total of 100 points.

Final award selections will be approved by the Assistant Secretary—Indian Affairs and the Associate Deputy Secretary, U.S. Department of the Interior. Applicants not selected for award will be notified in writing.

XII. Evaluation Criteria.

Proposals will be formally evaluated by an OIED review committee using the five criteria listed below. Each criterion provides a percentage of the total maximum rating of 100 points:

The Project's Economic Benefits: 50 points.

Project Deliverables: 20 Points.

Feasibility Process and Analysis: 10 points.

Costs of Proposal: 10 points.

Specificity: 10 points.

The reviewers will determine if the proposal's scope of work clearly states the opportunity to be studied. Factors that the reviewers will consider when awarding points are, but not limited to:

• Does the proposal describe how the project will potentially stimulate economic development?

• Does the proposal describe the benefits the project would have if implemented?

• Does the proposal include information how the project will reduce joblessness and stimulate economic activity within a Native community?

• Does the proposal describe the economic development challenges and how the study will address those conditions?

• Does the proposal describe if the applicant has the financial resources to conduct the study absent NABDI grant assistance?

The reviewers will determine if the proposal describes in detail applicable proposed deliverables. For example, a hotel feasibility study would include deliverables such as, but not limited to, site analysis, market demographics, drive-time market, regional competition, market demands, and a financial model that includes investment and return on investment projections.

The reviewers will determine if a comprehensive timeline has been developed to address tasks that are needed to successfully complete the objectives outlined in the scope of work.

The reviewers will assess the costs listed in the budget to determine if the overall value of the project is competitively priced and in accordance with the goals stated within the proposal/scope of work.

The reviewers understand applicants may retain consultant(s) that prepare the NABDI proposal to also conduct the feasibility study if the grant is awarded. This does not prejudice an applicant's chances of being selected as a grantee. However, the Committee will view unfavorably proposals that show little evidence of communication between the consultant(s) and the applicant or scant regard for the applicant community's unique circumstances. Facsimile applications prepared by the same consultant(s) and submitted by multiple applicants will receive scrutiny in this regard.

XIII. Transfer of Funds. OIED's obligation under this solicitation is contingent on receipt of congressionally appropriated funds. No liability on the part of the U.S. Government for any payment may arise until funds are made available to the awarding officer for this grant and until the recipient receives notice of such availability, to be confirmed in writing by the grant officer.

All payments under this agreement will be made by electronic funds transfer through the ASAP. All award recipients are required to have a current and accurate UEI number to receive funds. All payments will be deposited to the banking information designated by the applicant in the System for Award Management (SAM).

XIV. Reporting Requirements for Award Recipients. The applicant must deliver all products and data required by the Grant Agreement for the proposed NABDI feasibility study and business plan project to OIED within 30 days of the end of each reporting period and 120 days after completion of the project. The reporting periods will be established in the terms and conditions of the final award.

OIED requires that deliverable products be provided in digital format and submitted in the GrantSolutions system. Reports can be provided in either Microsoft Word or Adobe Acrobat PDF format. Spreadsheet data can be provided in Microsoft Excel, Microsoft Access, or Adobe PDF formats. All vector figures should be converted to PDF format. Raster images can be provided in PDF, JPEG, TIFF, or any of the Windows metafile formats. The contract between the grantee and the consultant conducting the NABDI funded feasibility study must include deliverable products and require that the products be prepared in the format described above.

The contract should include budget amounts for all printed and digital copies to be delivered in accordance with the grant agreement. In addition, the contract must specify that all products generated by a consultant belong to the grantee and cannot be released to the public without the grantee's written approval. Products include, but are not limited to, all reports and technical data obtained, maps, status reports, and the final report.

In addition, this funding opportunity and financial assistance award must adhere to the following provisions.

XV. Conflicts of Interest.

• This section intends to ensure that non-Federal entities and their employees take appropriate steps to avoid conflicts of interest in their responsibilities under or with respect to Federal financial assistance agreements.

• In the procurement of supplies, equipment, construction, and services by recipients and by sub-recipients, the conflict of interest provisions in 2 CFR 200.318 apply.

• Non-Federal entities must avoid prohibited conflicts of interest, including any significant financial interests that could cause a reasonable person to question the recipient's ability to provide impartial, technically sound, and objective performance under or with respect to a Federal financial assistance agreement.

• In addition to any other prohibitions that may apply with respect to conflicts of interest, no key official of an actual or proposed recipient or sub-recipient, who is substantially involved in the proposal or project, may have been a former Federal employee who, within the last one (1) year, participated personally and substantially in the evaluation, award, or administration of an award with respect to that recipient or sub-recipient or in development of the requirement leading to the funding announcement.

• No actual or prospective recipient or sub-recipient may solicit, obtain, or use non-public information regarding the evaluation, award, administration of an award to that recipient or sub-recipient or the development of a Federal financial assistance opportunity that may be of competitive interest to that recipient or sub-recipient.

• Non-Federal entities, including applicants for financial assistance awards, must disclose in writing any conflict of interest to the DOI awarding agency or pass-through entity in accordance with 2 CFR 200.112, Conflicts of Interest.

• Recipients must establish internal controls that include, at a minimum, procedures to identify, disclose, and mitigate or eliminate identified conflicts of interest. The recipient is responsible for notifying the Financial Assistance Officer in writing of any conflicts of interest that may arise during the life of the award, including those that have been reported by sub-recipients.

• Restrictions on Lobbying. Non-Federal entities are strictly prohibited from using funds under this grant or cooperative agreement for lobbying activities and must provide the required certifications and disclosures pursuant to 43 CFR part 18 and 31 U.S.C. 1352.

• Review Procedures. The Financial Assistance Officer will examine each conflict of interest disclosure on the basis of its particular facts and the nature of the proposed grant or cooperative agreement, and will determine whether a significant potential conflict exists and, if it does, develop an appropriate means for resolving it.

• Enforcement. Failure to resolve conflicts of interest in a manner that satisfies the Government may be cause for termination of the award. Failure to make the required disclosures may result in any of the remedies described in 2 CFR 200.338, Remedies for Noncompliance, including suspension or debarment (see also 2 CFR part 180).

• Applicability. The Department of the Interior is committed to basing its decisions on the best available science and providing the American people with enough information to thoughtfully and substantively evaluate the data, methodology, and analysis used by the Department to inform its decisions.

• Use of Data. The regulations at 2 CFR 200.315 apply to data produced under a Federal award, including the provision that the Federal Government has the right to obtain, reproduce, publish, or otherwise use the data produced under a Federal award as well as authorize others to receive, reproduce, publish, or otherwise use such data for Federal purposes.

• Availability of Data. The recipient shall make the data produced under this award and any subaward(s) available to the Government for public release, consistent with applicable law, to allow meaningful third-party evaluation and reproduction of the following:

○ The scientific data relied upon;

○ The analysis relied upon; and

○ The methodology, including models, used to gather and analyze data.

XVI. Questions and Requests for OIED Assistance. Technical consultation from OIED may include clarifying application requirements, confirming whether an applicant previously submitted the same or similar proposal, and registration information for SAM or ASAP. Technical assistance will be provided by the OIED contractor, Tribal Tech. The applicant is solely responsible for the preparation of its grant proposal. All eligible applicants will have access to scheduled training and can request assistance from the pre-application phase through the post-award close-out. It is strongly recommended that any assistance be a consolidation of items based off reasonably completed working drafts. Please complete an in-take form with Tribal Tech to request assistance: https://app.smartsheet.com/b/publish?EQBCT=98a8ecfd0f3d452693e589c6a0a678d8.

XVII. Paperwork Reduction Act: The information collection requirements contained in this notice have been reviewed and approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act, 44 U.S.C. 3504(h). The OMB control number is 4040-0004. The authorization expires on December 31, 2022. An agency may not conduct or sponsor, and you are not required to respond to, any information collection that does not display a currently valid OMB Control Number.

XVIII. Authority: This is a discretionary grant program authorized under the Snyder Act (25 U.S.C. 13) and the Consolidated Appropriations Act, 2022 (HR 2471-312). The Snyder Act authorizes the BIA to expend such moneys as Congress may appropriate for the benefit, care, and assistance of Indians for the purposes listed in the Act. NABDI grants facilitate two of the purposes listed in the Snyder Act: “General support and civilization, including education” and “industrial assistance and advancement.” The Consolidated Appropriations Act 2022 (HR 2471-312) authorizes the BIA “for expenses necessary for the operation of Indian programs, as authorized by law, including the Snyder Act of November 2, 1921 (25 U.S.C. 13) . . .”.

Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:

1. Type of Information Collection: Revision of a currently approved collection.

2. The Title of the Form/Collection: Application for Approval as a Nonprofit Budget and Credit Counseling Agency (Application).

3. The agency form number, if any, and the applicable component of the Department sponsoring the collection: There is no agency form number for this collection. The applicable component within the Department of Justice is the United States Trustee Program.

4. Affected public who will be asked or required to respond, as well as a brief abstract: Nonprofit agencies that wish to offer credit counseling services pursuant to the Bankruptcy Abuse Prevention and Consumer Protection Act of 2005 (“BAPCPA”), Public Law 109-8, 119 Stat. 23, 37, 38 (April 20, 2005), and codified at 11 U.S.C. 109(h) and 111, and Application Procedures and Criteria for Approval of Nonprofit Budget and Credit Counseling Agencies by United States Trustees, 78 FR 16,138 (March 14, 2013) (Rule).

The BAPCPA requires any individual who wishes to file for bankruptcy to obtain credit counseling, within 180 days before filing for bankruptcy relief, from a nonprofit budget and credit counseling agency that has been approved by the United States Trustee. The Application collects information from such agencies in order to ensure compliance with the law and the Rule.

5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: It is estimated that 86 respondents will complete the Application; initial applicants will complete the Application in approximately ten (10) hours, standard renewal applicants will complete the Application in approximately four (4) hours and refreshed renewal applicants will complete the Application in approximately five (5) hours.

6. An estimate of the total public burden (in hours) associated with the collection: The estimated public burden associated with this collection is 373 hours.

If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 3E.405A, Washington, DC 20530.

Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:

1. Type of Information Collection: Revision of a currently approved collection.

2. The Title of the Form/Collection: Application for Approval as a Provider of a Personal Financial Management Instructional Course (Application).

3. The agency form number, if any, and the applicable component of the Department sponsoring the collection: There is no agency form number for this collection. The applicable component within the Department of Justice is the United States Trustee Program.

4. Affected public who will be asked or required to respond, as well as a brief abstract: Individuals and businesses that wish to offer instructional courses to debtors concerning personal financial management pursuant to the Bankruptcy Abuse Prevention and Consumer Protection Act of 2005 (“BAPCPA”), Public Law 109-8, 119 Stat. 23, 37, 38 (April 20, 2005), and codified at 11 U.S.C. 109(h) and 111, and Application Procedures and Criteria for Approval of Providers of a Personal Financial Management Instructional Course by United States Trustees, 78 FR 16,159 (March 14, 2013) (Rule).

The BAPCPA requires individual debtors in bankruptcy cases to complete a personal financial management instructional course given by a provider that has been approved by the United States Trustee as a condition of receiving a discharge. The Application collects information from such providers in order to ensure compliance with the law and the Rule.

5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: It is estimated that 135 respondents will complete the Application; initial applicants will complete the Application in approximately ten (10) hours, standard renewal applicants will complete the Application in approximately four (4) hours and refreshing renewal applicants will complete the Application in approximately five (5) hours. In addition, it is estimated that approximately 602,344 debtors will complete a survey evaluating the effectiveness of an instructional course in approximately one (1) minute.

6. An estimate of the total public burden (in hours) associated with the collection: The estimated total annual public burden associated with this Application is 10,620 hours; the applicants' burden is 581 hours and the debtors' burden is 10,039 hours.

If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 3E.405A, Washington, DC 20530.

Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:

1. Type of Information Collection (check justification or form 83) : Extension with Change of a Currently Approved Collection.

2. The Title of the Form/Collection: Transactions Among Licensees/Permittees, Limited.

3. The agency form number, if any, and the applicable component of the Department sponsoring the collection:

Form number (if applicable): None.

Component: Bureau of Alcohol, Tobacco, Firearms and Explosives, U.S. Department of Justice.

4. Affected public who will be asked or required to respond, as well as a brief abstract:

Primary: Business or other for-profit.

Other (if applicable): None.

Abstract: This information collection outlines specific requirements regarding limited explosive permits, and also allows the Bureau of Alcohol, Tobacco, Firearms and Explosives to implement provisions of the Safe Explosives Act.

5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: An estimated 100 respondents will respond to this collection once annually, and it will take each respondent approximately 30 minutes to complete their responses.

6. An estimate of the total public burden (in hours) associated with the collection: The estimated annual public burden associated with this collection is 50 hours, which is equal to 100 (total respondents) * 1(# of response per respondent) * .5 (30 minutes or the time taken to prepare each response).

7. An Explanation of the Change in Estimates: Due to fewer limited explosive permitees, both the total responses and burden hours have reduced by 25 and 13 hours respectively since the last renewal in 2019.

If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, Mail Stop 3.E-405A, Washington, DC 20530.

On December 27, 2020, the Consolidated Appropriations Act, 2021 (CAA), which includes the No Surprises Act, was signed into law. The No Surprises Act provides Federal protections against surprise billing and limits out-of-network cost sharing under many of the circumstances in which surprise bills arise most frequently. Section 102 of the No Surprises Act added Code section 9816, ERISA section 716, and PHS Act section 2799A-1, which contain limitations on cost sharing and requirements for initial payments for emergency services. In addition, Section 103 of the No Surprises Act amended Code section 9816, ERISA section 716, and PHS Act section 2799A-1 to establish a Federal independent dispute resolution (Federal IDR) process that nonparticipating providers or facilities and group health plans and health insurance issuers in the group and individual market may use following the end of an unsuccessful open negotiation period to determine the out-of-network rate for certain services. The Federal IDR process requires a number of disclosures from plans, issuers, FEHB carriers, and nonparticipating providers or nonparticipating emergency facilities. For additional substantive information about this ICR, see the related notice published in the Federal Register on November 9, 2021 (86 FR 62206). On April 5, 2022, the Department of Labor submitted another emergency request to revise the ICR to remove language to be consistent with the federal court ruling in the U.S. District Court for the Eastern District of Texas on the Interim Final Rule, Requirements Related to Surprise Billing; Part II ( Texas Medical Association v. HHS ). The ICR Revision was approved by OMB on April 11, 2022. The Departments welcome comments on those revisions. For additional substantive information, see the related submission at https://www.reginfo.gov/public/do/PRAOMBHistory?ombControlNumber=1210-0169.

This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless the OMB approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid OMB Control Number. See 5 CFR 1320.5(a) and 1320.6.

DOL seeks PRA authorization for this information collection for three (3) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOL notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review.

Agency: DOL-EBSA.

Title of Collection: No Surprises Act: IDR Process.

OMB Control Number: 1210-0169.

Affected Public: Private Sector—Businesses or other for-profits and not-for-profit institutions.

Total Estimated Number of Respondents: 22,428.

Total Estimated Number of Responses: 36,964.

Total Estimated Annual Time Burden: 68,193 hours.

Total Estimated Annual Other Costs Burden: $545,727.

OMB Number: 3133-0004.

Title: NCUA Call Report.

Form: NCUA Form 5300.

Type of Review: Extension of a currently approved collection.

Abstract: Sections 106 and 202 of the Federal Credit Union Act require federally insured credit unions to make financial reports to the NCUA. Section 741.5 prescribes the method in which federally insured credit unions must submit this information to the NCUA. NCUA Form 5300, Call Report, is used to file quarterly financial and statistical data through the NCUA's online portal, CUOnline.

The financial and statistical information is essential to the NCUA in carrying out its responsibility for supervising federal credit unions. The information also enables the NCUA to monitor all federally insured credit unions with National Credit Union Share Insurance Fund (NCUSIF) insured share accounts.

Affected Public: Private Sector: Not-for-profit institutions.

Estimated No. of Respondents: 5,097.

Estimated No. of Responses per Respondent: 4.

Estimated Total Annual Responses: 20,388.

Estimated Burden Hours per Response: 4.

Estimated Total Annual Burden Hours: 81,552.

Reason for Change: The Office of Management and Budget (OMB) approved a revision to this information collection requirement as an emergency in accordance with 5 CFR 1320.13, which is set to expire July 31, 2022. The Call Report was restructured to accommodate the Complex Credit Union Leverage Ratio (CCULR) Calculation schedule by adding a schedule for the CCULR Calculation and to reestablish the account code for the collection of Noncontrolling Interest in Consolidated Subsidiaries (previously described as Miscellaneous Equity and erroneously omitted from the Form 5300). The CCULR changes were attributed to a final rule published December 23, 2021, at 86 FR 72784, that provided a simplified measure of capital adequacy for federally insured, natural-person credit unions classified as complex.

OMB Number: 3133-0185.

Title: NCUA Vendor Registration Form.

Form: NCUA Form 1772.

Type of Review: Extension of a currently approved collection.

Abstract: Section 342 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Act) (Pub. L. 111-203) calls for agencies to promote the inclusion of minority and women-owned firms in their business activities. The Act also requires agencies to annually report to Congress the total amounts paid to minority and women-owned businesses. In order for NCUA to comply with this Congressional mandate, NCUA Form 1772 is used to collect certain information from its current and potential vendors, so that it can identify businesses that meet the criteria. The vendor information is to be submitted to the agency on a one-time basis and will be used to assign an ownership status to the vendor ( i.e., minority-owned business, woman-owned business) per the requirements of the Act. The NCUA will use the vendor-entered ownership status information to help calculate the total amounts of contracting dollars awarded and paid to minority-owned and women-owned businesses.

Affected Public: Private Sector: Businesses or other for-profits.

Estimated No. of Respondents: 200.

Estimated Annual Frequency: 1.

Estimated Annual Number of Responses: 200.

Estimated Burden Hours per Response: 10 minutes.

Estimated Total Annual Burden Hours: 33.

Request for Comments: Comments submitted in response to this notice will be summarized and included in the request for Office of Management and Budget approval. All comments will become a matter of public record. The public is invited to submit comments concerning: (a) Whether the collection of information is necessary for the proper execution of the function of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information, including the validity of the methodology and 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 the information on the respondents, including the use of automated collection techniques or other forms of information technology.

By Melane Conyers-Ausbrooks, Secretary of the Board, the National Credit Union Administration, on April 19, 2022.

The closed portions of meetings are for the purpose of Panel review, discussion, evaluation, and recommendations on financial assistance under the National Foundation on the Arts and the Humanities Act of 1965, as amended, including information given in confidence to the agency. In accordance with the determination of the Chair of March 11, 2022, these sessions will be closed to the public pursuant to subsection (c)(6) of section 552b of title 5, United States Code.

The upcoming meeting is:

Federal Advisory Committee on International Exhibitions (review of applications):

This meeting will be closed.

Date and time: May 12, 2022, 2:00 p.m. to 4:00 p.m.

Please refer to Docket ID NRC-2022-0023 when contacting the NRC about the availability of information for this action. You may obtain publicly available information related to this action by any of the following methods:

• Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2022-0023. A copy of the collection of information and related instructions may be obtained without charge by accessing Docket ID NRC-2022-0023 on this website.

• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly available documents online in the ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to PDR.Resource@nrc.gov. A copy of the collection of information and related instructions may be obtained without charge by accessing ADAMS Accession No. ML22088A049. The supporting statement is available in ADAMS under Accession No. ML22021B056.

• NRC's PDR: You may examine and purchase copies of public documents, by appointment, at the NRC's PDR, Room P1 B35, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. To make an appointment to visit the PDR, please send an email to PDR.Resource@nrc.gov or call 1-800-397-4209 or 301-415-4737, between 8:00 a.m. and 4:00 p.m. (ET), Monday through Friday, except Federal holidays.

• NRC's Clearance Officer: A copy of the collection of information and related instructions may be obtained without charge by contacting the NRC's Clearance Officer, David Cullison, Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2084; email: Infocollects.Resource@nrc.gov.

The NRC encourages electronic comment submission through the Federal rulemaking website ( https://www.regulations.gov ). Please include Docket ID NRC-2022-0023, in your comment submission.

The NRC cautions you not to include identifying or contact information in comment submissions that you do not want to be publicly disclosed in your comment submission. All comment submissions are posted at https://www.regulations.gov and entered into ADAMS. Comment submissions are not routinely edited to remove identifying or contact information.

If you are requesting or aggregating comments from other persons for submission to the OMB, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that comment submissions are not routinely edited to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the NRC is requesting public comment on its intention to request the OMB's approval for the information collection summarized below.

1. The title of the information collection: Cooperation with States at Commercial Nuclear Power Plants and Other Nuclear Production and Utilization Facilities, Policy Statement.

2. OMB approval number: 3150-0163.

3. Type of submission: Extension.

4. The form number, if applicable: Not applicable.

5. How often the collection is required or requested: On occasion, when a State or Federally recognized Indian Tribe wishes to observe NRC inspections or perform inspections for the NRC or when a State or Federally recognized Indian Tribe wishes to negotiate an agreement to observe or perform inspections. States with an instrument of cooperation or a State Resident Engineer have both regular reporting and occasion-specific reporting.

6. Who will be required or asked to respond: States and Federally recognized Tribes interested in observing or performing inspections.

7. The estimated number of annual responses: 207.

8. The estimated number of annual respondents: 33.

9. The estimated number of hours needed annually to comply with the information collection requirement or request: 1,291.

10. Abstract: States and Federally recognized Indian Tribes are involved and interested in monitoring the safety status of nuclear power plants and other nuclear production and utilization facilities. This involvement is, in part, in response to the States' and Tribes' public health and safety responsibilities and, in part, in response to their citizens' desire to become more knowledgeable about the safety of nuclear power plants and other nuclear production and utilization facilities. States and Tribes have identified NRC inspections as one possible source of knowledge for their personnel regarding NRC licensee activities, and the NRC, through the policy statement, “Cooperation With States at Commercial Nuclear Power Plants and Other Nuclear Production or Utilization Facilities” (57 FR 6462; February 25, 1992), has been amenable to accommodating States' and Tribes' needs in this regard. The NRC uses the information collected under this information collection requirement to allow States and Federally recognized Indian Tribes to participate in or observe inspections at NRC-licensed facilities. The types of information collected include written requests identifying specific inspections States and Tribes wish to observe; identification-related information required for site access to NRC-licensed facilities; training and qualifications of State and Tribal personnel participating in inspections; information required to define inspection roles for States and Tribes; and information to coordinate NRC and State and Tribal inspections.

The NRC is seeking comments that address the following questions:

1. Is the proposed collection of information necessary for the NRC to properly perform its functions? Does the information have practical utility?

2. Is the estimate of the burden of the information collection accurate?

3. Is there a way to enhance the quality, utility, and clarity of the information to be collected?

4. How can the burden of the information collection on respondents be minimized, including the use of automated collection techniques or other forms of information technology?

Under Executive Order 14043, every Federal agency must “implement, to the extent consistent with applicable law, a program to require COVID-19 vaccination for all of its Federal employees, with exceptions only as required by law.” In following this directive, the Pension Benefit Guaranty Corporation (PBGC) imposed a requirement that its employees must receive and submit proof of a COVID-19 vaccination. As required by 29 U.S.C. 701 et seq. and 29 CFR part 1630, PBGC allows an exception from the vaccination requirement for employees who demonstrate medical reasons or disabilities that would make the COVID-19 vaccine unsafe for them. To obtain this exception, employees must complete the Request for Medical Exception to COVID-19 Vaccination Requirement form. PBGC uses the information on this form to verify employees' assertions that they are entitled to an exception to the COVID-19 vaccination requirement because of their medical or disability statuses.

The medical exception request collection of information has been approved by OMB under control number 1212-0075 (expires May 31, 2022). On February 14, 2022, PBGC published in the Federal Register (at 87 FR 8303) a notice informing the public of its intent to request an extension of this collection of information. PBGC received one comment, and the commenter expressed support for the exemption, noting that some employees may have disabling conditions. PBGC is requesting that OMB extend approval of the collection for 3 years. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

PBGC estimates that an average of 2 employees each year will submit Request for Medical Exception to COVID-19 Vaccination Requirement forms. The total estimated annual burden of the collection of information is 0.5 hours and $0.

As of the date that PBGC submitted this notice to the Federal Register , the vaccination requirement issued pursuant to E.O. 14043 is currently the subject of a nationwide injunction. While that injunction remains in place, PBGC will not process requests for a medical exception from the COVID-19 vaccination requirement pursuant to E.O. 14043. PBGC will also not request the submission of any medical information related to a request for an exception from the vaccination requirement pursuant to E.O. 14043 while the injunction remains in place. But PBGC may nevertheless receive information regarding a medical exception. That is because, if PBGC were to receive a request for an exception from the COVID-19 vaccination requirement pursuant to E.O. 14043 during the pendency of the injunction, PBGC will accept the request, hold it in abeyance, and notify the employee who submitted the request that implementation and enforcement of the COVID-19 vaccination requirement pursuant to E.O. 14043 is currently enjoined and that an exception therefore is not necessary so long as the injunction is in place. In other words, during the pendency of the injunction, any information collection related to requests for medical exception from the COVID-19 vaccination requirement pursuant to E.O. 14043 is not undertaken to implement or enforce the COVID-19 vaccination requirement.

On April 14, 2022, the Postal Service filed a motion for consideration of its stipulation and agreement regarding the advisory opinion in this proceeding in accordance with 39 CFR 3010.320. 1 The Stipulation and Agreement, negotiated between the only two parties in this proceeding—the Postal Service and the Public Representative, concerns certain procedural and evidentiary matters. Specifically, the Postal Service and the Public Representative agree that the direct testimony of Postal Service witnesses, supporting Library References, and any designated response to the Presiding Officer's Information Requests provide substantial evidence supporting an advisory opinion. Motion, Stipulation and Agreement at 2.

They also agree that neither a hearing nor oral argument or examination are necessary in determining whether the proposed service standard changes are in accordance with the policies of Title 39 of the United States Code and in furtherance of the public interest. Id. In addition, they agree that they will file no further discovery requests or testimony, unless requested by the Commission. However, both parties reserve the right to submit initial or reply briefs, if necessary. Id.

The Postal Service states that it will move for the admission into record evidence the testimonies and supporting documentation. Id. The Postal Service also states that it will move for the adoption of a revised procedural schedule, removing the dates for the hearing, modifying the deadline to file designated materials, and shortening the time to file reply briefs, if necessary:

Id. at 2-3. The Motion is granted. Having considered the Stipulation and Agreement, the Presiding Officer finds that, based on the agreement between parties, certain procedural events can be removed from the schedule. See 39 CFR 3020.110(b). Moreover, adopting the Stipulation and Agreement will not affect the ability of interested parties to participate ( i.e., file statements of position) in this proceeding.

Accordingly, the Presiding Officer adopts the revised schedule as proposed by the Postal Service. 2 Accompanying this Ruling is an updated version of the Procedural Schedule (Attachment) for Docket No. N2022-1.

It is ordered:

1. The Motion of the United States Postal Service for Consideration of the Stipulation and Agreement as the Basis for Advisory Opinion, filed April 14, 2022, is granted.

2. The modified procedural schedule for this proceeding is set forth below the signature of this Ruling.

3. The Secretary shall arrange for publication of this Ruling in the Federal Register .