Members of the public may listen to this discussion through the above call-in number (audio only) or online registration link (audio/visual). 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. Individual who is 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 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 Melissa Wojnaroski at mwojnaroski@usccr.gov.

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, Ohio 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.

Members of the public may join online or listen to this discussion through the above call-in number. 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. 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 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 Melissa Wojnaroski at mwojnaroski@usccr.gov.

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, Arkansas 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.

I. Abstract

Over the years, BIS has worked with other Government agencies and the affected public to identify areas where export licensing requirements may be relaxed without jeopardizing U.S. national security or foreign policy. Many of these relaxations have taken the form of licensing exceptions and exclusions. Some of these license exceptions and exclusions have a reporting or recordkeeping requirement to enable the Government to continue to monitor exports of these items. Exporters may choose to utilize the license exception and accept the reporting or recordkeeping burden in lieu of submitting a license application. These exceptions and exclusions have allowed exporters to ship items quickly, without having to wait for license approval.

Electronic.

OMB Control Number: 0694-0137.

Form Number(s): None.

Type of Review: Regular submission, extension of a current information collection.

Affected Public: Business or other for-profit organizations.

Estimated Number of Respondents: 19,738.

Estimated Time per Response: 1.52 hours.

Estimated Total Annual Burden Hours: 29,998.

Estimated Total Annual Cost to Public: 0.

Respondent's Obligation: Voluntary.

Legal Authority: Export Control Reform Act (ECRA) of 2018.

We are soliciting public comments to permit the Department/Bureau to: (a) Evaluate whether the proposed information collection is necessary for the proper functions of the Department, including whether the information will have practical utility; (b) Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used; (c) Evaluate ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.

Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. 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 may 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.

The Committee shall consist of approximately 35 members appointed by the Secretary in accordance with applicable Department of Commerce guidance and based on their ability to carry out the objectives of the Committee. Members shall represent U.S. companies, U.S. trade associations, U.S. private sector organizations, and civil society groups with activities focused on the export competitiveness of U.S. renewable energy and energy efficiency goods and services. The Committee shall also represent the range of company or organizational roles in the development of renewable energy and energy efficiency projects, including, for example, project developers, technology integrators, financial institutions, and manufacturers. Members of the Committee are selected, in accordance with applicable Department of Commerce guidelines, based on their ability to carry out the objectives of the Committee as set forth in the Charter and in a manner that ensures that the Committee is balanced in terms of points of view, industry subsector, geography, and company size. The diverse membership of the Committee assures perspectives reflecting the full breadth of the Committee's responsibilities, and, where possible, the Department of Commerce will also consider the ethnic, racial, and gender diversity and various abilities of the United States population.

Members serve at the pleasure of the Secretary from the date of appointment to the Committee to the date on which the Committee's charter terminates. Members serve in a representative capacity presenting the views and interests of a U.S. entity or U.S. organization, as well as their particular subsector; they are, therefore, not Special Government Employees.

Members of the Committee must not be registered as foreign agents under the Foreign Agents Registration Act. No member may represent a company that is majority owned or controlled by a foreign government entity (or foreign government entities). Members of the Committee will not be compensated for their services or reimbursed for their travel expenses.

If you are interested in applying or nominating someone else to become a member of the Committee, please provide the following information:

(1) Sponsor letter on the company's, trade association's or organization's letterhead containing the name, title, and relevant contact information (including phone and email address) of the individual who is applying or being nominated;

(2) An affirmative statement that the nominee will be able to meet the expected time commitments of Committee work. Committee work includes (1) attending in-person committee meetings roughly four times per year (lasting one day each), (2) undertaking additional work outside of full committee meetings including subcommittee conference calls or meetings as needed, and (3) frequently drafting, preparing, or commenting on proposed recommendations to be evaluated at Committee meetings;

(3) Short biography of nominee, including credentials;

(4) Brief description of the company, trade association, or organization to be represented and its business activities; company size (number of employees and annual sales); and export markets served;

(5) An affirmative statement that the nominee meets all Committee eligibility requirements.

Please do not send company, trade association, or organization brochures or any other information. See the ADDRESSES and DATES captions above for how and the deadline for submitting nominations.

Nominees selected for appointment to the Committee will be notified by email.

Background

On June 22, 2020, Commerce published the CVD order on QSP from India. 1 On June 29 and June 30, 2021, Commerce received timely requests for administrative reviews of several companies from various interested parties, in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.213(b). 2 On July 26, 2021, Arizona Tile, LLC's (Arizona Tile) and M.S. International, Inc. (MSI) withdrew their respective requests for reviews in their entirety. 3 On July 28, 2021, Pokarna Engineered Stone Limited's (PESL) withdrew its request for a review. 4 On August 3, 2021, the interested parties who submitted the Various Indian Producers/Exporters Group One Review Request withdrew their request for reviews in its entirety. 5 On August 9, 2021, Commerce published in the Federal Register a notice of initiation on QSP from India covering 24 producers/exporters. 6 On August 12, 2021, the interested parties who submitted the Various Indian Producers/Exporters Group Two Review Request withdrew their request for reviews in its entirety. 7 Due to the withdrawal of review requests submitted by various interested parties, DSG remains the sole Indian producer/exporter of QSP for which an administrative review was requested.

On February 17, 2022, Commerce extended the deadline for the preliminary results of this administrative review until June 30, 2022. 8

For a complete description of the events that followed the Initiation of this review, see the Preliminary Decision Memorandum. 9 A list of topics discussed in the Preliminary Decision Memorandum is included as an appendix to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at https://access.trade.gov/public/FRNoticesListLayout.aspx.

The merchandise covered by the Order is QSP from India. For a complete description of the scope of the order, see the Preliminary Decision Memorandum.

Commerce is conducting this review in accordance with section 751(a)(1)(A) of the Act. For each of the subsidy programs found countervailable, we preliminarily determine that there is a subsidy, i.e., a government financial contribution that gives rise to a benefit to the recipient, and that the subsidy is specific. 10 For a full description of the methodology underlying our conclusions, see the Preliminary Decision Memorandum. Rescission of Administrative Review, in Part Pursuant to 19 CFR 351.213(d)(1), Commerce will rescind an administrative review, in whole or in part, if the party that requested a review withdraws the request within 90 days of the publication date of the notice of initiation of the requested review. On August 9, 2021, Commerce published the Initiation. 11 The withdrawal requests of Arizona Tile, MSI, PESL, and groups one and two of the Various Indian Producers/Exporters were timely submitted. 12 Therefore, in accordance with 19 CFR 351.213(d)(1), we are rescinding this administrative review of the Order, in part, with respect to the following 23 companies: (1) Antique Marbonite Private Limited; (2) Argil Ceramics; (3) ARO Granite Industries Limited; (4) Baba Super Minerals Pvt. Ltd.; (5) Camrola Quartz Limited; (6) Cuarzo; (7) Esprit Stones Pvt. Ltd.; (8) Global Stones Pvt. Ltd.; (9) Hi Elite Quartz LLP, India; (10) Keros Stone LLP; (11) Mahi Granites Private Limited; (12) Malbros Marbles & Granites Industries; (13) Pacific Industries Limited; (14) Pacific Quartz Surfaces LLP; (15) Paradigm Stone India Pvt. Ltd.; (16) Pelican Quartz Stone; (17) PESL; (18) Rocks Forever; (19) Satya Exports; (20) Shivam Enterprises; (21) Southern Rocks and Minerals Pvt. Ltd.; (22) Sunex Stones Private Limited, India; and (23) Tab India Granites Private Limited, India.

Commerce preliminarily determines that the following countervailable subsidy rate exists for DSG for the period October 11, 2019, through December 31, 2020:

Consistent with section 751(a)(2)(C) of the Act and 19 CFR 351.212(b)(2), upon issuance of the final results, Commerce will determine, and U.S. Customs and Border Protection (CBP) shall assess, countervailing duties on all appropriate entries covered by this review. For DSG, Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the Federal Register . If a timely summons is filed at the U.S. Court of International Trade, the assessment instructions will direct CBP not to liquidate relevant entries until the time for parties to file a request for a statutory injunction has expired ( i.e., within 90 days of publication).

With respect to the companies for which this administrative review is rescinded, following the publication of this Federal Register notice, we will instruct CBP to assess countervailing duties on all appropriate entries at rates equal to the cash deposit rate required at the time of entry, or withdrawal from warehouse, for consumption, during the period October 11, 2019, through December 31, 2020, in accordance with 19 CFR 351.212(c)(1)(i).

In accordance with section 751(a)(2)(C) of the Act, Commerce also intends to instruct CBP to collect cash deposits of estimated CVDs in the amount indicated above ( i.e., the rate calculated for calendar year 2020) with regard to shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the date of publication of the final results of this review. For all non-reviewed firms, Commerce will instruct CBP to continue to collect cash deposits of estimated CVDs at the most recent company-specific or all others rate applicable to the company, as appropriate. These cash deposit instructions, when imposed, shall remain in effect until further notice.

We will disclose to parties in this proceeding the calculations performed in reaching the preliminary results within five days of publication of these preliminary results in the Federal Register . 13 Interested parties may submit written comments (case briefs) on the preliminary results no later than 30 days from the date of publication of this Federal Register notice, and rebuttal comments (rebuttal briefs) within seven days after the time limit for filing case briefs. 14 Pursuant to 19 CFR 351.309(d)(2), rebuttal briefs must be limited to issues raised in the case briefs. Parties who submit arguments are requested to submit with the argument: (1) a statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities. 15

Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS by 5 p.m. Eastern Time within 30 days after the date of publication of this notice. 16 Hearing requests should contain: (1) the party's name, address, and telephone number; (2) the number of participants; and (3) a list of the issues to be discussed. Issues addressed at the hearing will be limited to those raised in the briefs. If a request for a hearing is made, Commerce intends to hold the hearing at a date and time to be determined. 17 Parties should confirm by telephone the date and time of the hearing two days before the scheduled date.

Parties are reminded that all briefs and hearing requests are to be filed electronically using ACCESS and that electronically filed documents must be received successfully in their entirety by 5 p.m. Eastern Time on the due date. Note that Commerce has temporarily modified certain of its requirements for serving documents containing business proprietary information, until further notice. 18

Commerce intends to issue the final results of this administrative review, including the results of our analysis of the issues raised by the parties in their comments, no later than 120 days after the date of publication of this notice, pursuant to section 751(a)(3)(A) of the Act and 19 CFR 351.213(h), unless this deadline is extended.

These preliminary results are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.213 and 19 CFR 351.221(b)(4).

The timing of U.S. SAS and GAC meetings are adjusted based on the dates of the IATTC Annual Meeting. This year, the IATTC convened its 13th Meeting of the Scientific Advisory Committee (SAC) on May 16-20, 2022, and the 100th Annual Meeting of the IATTC will be held on August 1-5, 2022. For 2022, the combined U.S. SAS and GAC Meeting will be held after the IATTC SAC Meeting and before the IATTC Annual Meeting on June 29 and 30. This timing allows for scientific topics presented at the IATTC SAC Meeting, including stock assessments, to be discussed and used to inform U.S. positions at the combined U.S. SAS and GAC Meeting. This meeting will also include updates from IATTC working groups and presentation of draft U.S. proposals to be submitted to the IATTC. An executive session may be called in order to discuss sensitive information, including possible U.S. negotiating positions for the upcoming IATTC Annual Meeting.

In accordance with the Tuna Conventions Act (16 U.S.C. 951 et seq. ), the U.S. Department of Commerce, in consultation with the Department of State (the State Department), appoints a GAC to the U.S. Section to the IATTC, and a SAS that advises the GAC. The U.S. Section consists of the four U.S. Commissioners and alternate U.S. Commissioners to the IATTC and representatives of the State Department, NOAA, Department of Commerce, other U.S. Government agencies, and stakeholders. The GAC provides recommendations to the U.S. section of the IATTC. The purpose of the SAS is to advise the GAC on scientific matters and provide recommendations to the GAC. Per TCA, the SAS advises the GAC and the U.S. Commissioners on matters including the conservation of ecosystems, the sustainable uses of living marine resources related to the tuna fishery in the eastern Pacific Ocean, and the long-term conservation and management of stocks of living marine resources in the eastern tropical Pacific Ocean. NMFS West Coast Region staff provides administrative and technical support services as necessary for the effective functioning of the SAS and GAC.

The meetings of the SAS and GAC are open to the public, unless in executive session. The time and manner of public comment will be at the discretion of the Chairs for the SAS and GAC. For more information and updates on these upcoming meetings, please visit the IATTC's website: https://www.iattc.org/MeetingsENG.htm.

Given the virtual nature of these meetings, the agenda will be concise. The SAS and GAC meeting to prepare for the 100th IATTC Annual Meeting is expected to cover a broad spectrum of topics including but not limited to:

(1) Outcomes of the most recent IATTC stock assessments and updates for tuna, tuna-like species, and other species caught in association with those fisheries in the eastern Pacific Ocean;

(2) Evaluation of the IATTC Staff's Recommendations to the Commission for 2022;

(3) Potential U.S. proposal(s) to the IATTC, including on North Pacific albacore;

(4) Updates for upcoming Joint IATTC-WCPFC NC Working Group on PBF meeting;

(5) Recommendations and evaluations by the SAS and GAC; and

(6) Other issues as they arise.

Requests for sign language interpretation or other auxiliary aids should be directed to William Stahnke (see FOR FURTHER INFORMATION CONTACT ).

Authority: 16 U.S.C. 951 et seq.

Notices were published in the Federal Register on the dates listed below that requests for a permit, permit amendment, or permit modification had been submitted by the below-named applicants. To locate the Federal Register notice that announced our receipt of the application and a complete description of the activities, go to www.federalregister.gov and search on the permit number provided in Table 1 below.

In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq. ), a final determination has been made that the activities proposed are categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement.

As required by the ESA, as applicable, issuance of these permits was based on a finding that such permits: (1) were applied for in good faith; (2) will not operate to the disadvantage of such endangered species; and (3) are consistent with the purposes and policies set forth in Section 2 of the ESA.

Authority: The requested permits have been issued under the MMPA of 1972, as amended (16 U.S.C. 1361 et seq. ), the regulations governing the taking and importing of marine mammals (50 CFR part 216), the ESA of 1973, as amended (16 U.S.C. 1531 et seq. ), and the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR parts 222-226), as applicable.

DOE and BOEM will hold stakeholder workshops to identify technical planning and development; economics and policy; and siting and permitting recommendations to address near-, medium-, and long-term OSW transmission challenges. This workshop on “Sharing the Benefits and Opportunities for Atlantic Offshore Wind Transmission” will be held in a virtual format on Tuesday, June 28, 2022 from 8:00 a.m. to 12:00 p.m. EDT. The workshop will include presentations, panel discussions, and moderated discussion. The workshop will present educational background on OSW transmission and related ongoing federal activities. Participants will individually have the opportunity to ask questions, provide input, and share feedback. Persons interested in attending this virtual workshop must register online at: Atlantic Offshore Wind Stakeholder Workshop no later than Tuesday, June 21, 2022. Please check the website for additional information, including a detailed agenda, list of presentations, resource materials, and instructions to submit comments.

This document of the Department of Energy was signed on June 9, 2022, by Gilbert C. Bindewald III, Acting Principal Deputy Assistant Secretary, Office of Electricity 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. The administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

Title: FERC-542, Gas Pipelines Rates: Rate Tracking.

OMB Control No.: 1902-0070.

Type of Request: Three-year extension of the FERC-542 information collection requirements with no changes to the current reporting requirements.

Abstract: The Commission uses FERC-542 filings to verify that costs which are passed through to pipeline customers as rate adjustments are consistent with the Natural Gas Policy Act (NGPA), 15 U.S.C. 3301-3432, and sections 4 and 5 of the Natural Gas Act (NGA), 15 U.S.C. 717c and 717d. These statutory provisions require FERC to regulate the transmission and sale of natural gas for resale in interstate commerce at just and reasonable rates. This collection of information is also in accordance with section 16 of the NGA, 15 U.S.C. 717 o, which authorizes FERC to implement the NGA through its rules and regulations.

The regulations at 18 CFR part 154 include provisions that allow an interstate natural gas pipeline to submit filings seeking to:

• Recover research, development and demonstration expenditures (18 CFR 154.401);

• Recover annual charges assessed by the Commission under 18 CFR part 382 (18 CFR 154.402); and

• Pass through, on a periodic basis, a single cost or revenue item such as fuel use and unaccounted-for natural gas in kind (18 CFR 154.403).

FERC-542 filings may be submitted at any time or on a regularly scheduled basis in accordance with the pipeline company's tariff. Filings may be: (1) accepted; (2) suspended and set for hearing; (3) minimal suspension; or (4) suspended for further review, such as technical conference or some other type of Commission action. The Commission implements these filing requirements under 18 CFR part 154.

Type of Respondents: Jurisdictional Natural Gas Pipelines.

Estimate of Annual Burden:   1 The Commission estimates the total burden and cost for this information collection as follows:

Comments: Comments are invited on: (1) whether the collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.

Title: Standards of Conduct for Transmission Provider and Marketing Affiliates of Interstate Pipelines.

OMB Control No.: 1902-0157.

Type of Request: Three-year extension of the FERC-592 information collection requirements with no changes to the current reporting requirements.

Abstract: The Commission uses the information maintained and posted by the respondents to monitor the pipeline's transportation, sales, and storage activities for its marketing affiliate to deter undue discrimination by pipeline companies in favor of their marketing affiliates. Non-affiliated shippers and other entities ( e.g., state commissions) also use the information to determine whether they have been harmed by affiliate preference and to prepare evidence for proceedings following the filing of a complaint.

Respondents maintain and provide the information required by 18 CFR part 358 on their internet websites. When the Commission requires a pipeline to post information on its website following a disclosure of non-public information to its marketing affiliate, non-affiliated shippers obtain comparable access to the non-public transportation information, which allows them to compete with marketing affiliates on a more equal basis.

This form (log/format) provides the electronic formats for maintaining information on discounted transportation transactions and capacity allocation to support monitoring of activities of interstate pipeline marketing affiliates. Commission staff considers discounts given to shippers in litigated rate cases.

Without this information collection:

• the Commission would be unable to effectively monitor whether pipelines are giving discriminatory preference to their marketing affiliates; and

• non-affiliated shippers and state commissions and others would be unable to determine if they have been harmed by affiliate preference or prepare evidence for proceedings following the filing of a complaint.

Type of Respondents: Natural gas pipelines.

Estimate of Annual Burden:   1 The Commission estimates the annual reporting burden and cost for the information collection as shown in the following table:

Comments are invited on: (1) whether the collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.

Title: FERC-912, PURPA Section 210(m) Notification Requirements Applicable to Cogeneration and Small Power Production Facilities.

OMB Control No.: 1902-0237.

Type of Request: Three-year extension of the FERC-912 information collection requirements with no changes to the current reporting requirements.

Abstract: On 8/8/2005, the Energy Policy Act of 2005 (EPAct 2005)  1 was signed into law. Section 1253(a) of EPAct 2005 amends Section 210 of the Public Utility Regulatory Policies Act of 1978 (PURPA) by adding subsection “(m),” that provides, based on a specified showing, for the termination and subsequent reinstatement of an electric utility's obligation to purchase from, and sell energy and capacity to, qualifying facilities (QFs). In 2019, the Commission revised its regulations in 18 CFR 292.309-292.313 in Docket No. RM19-15-000 to account for industry changes. These industry changes include: the decrease in reliance on oil and natural gas, the increase of natural gas supply due to access of shale reserves, and the decreasing costs of renewable energy sources. Due to the modifications in the rulemaking, the Commission revised its information collection requirements. The Commission now collects the following information on FERC Form 912:

• § 292.310: an electric utility's application for the termination of its obligation to purchase energy from a QF,

• § 292.311: an affected entity or person's application to the Commission for an order reinstating the electric utility's obligation to purchase energy from a QF,

• § 292.312: an electric utility's application for the termination of its obligation to sell energy and capacity to QFs, and

• § 292.313: an affected entity or person's application to the Commission for an order reinstating the electric utility's obligation to sell energy and capacity to QFs. 2

Type of Respondents: Electric utilities.

Estimate of Annual Burden:   3

The Commission estimates the total Public Reporting Burden and cost for this information collection as follows:

Comments: Comments are invited on: (1) whether the collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.

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: The National Emission Standards for Hazardous Air Pollutants (NESHAP) for Primary Magnesium Refining (40 CFR part 63, subpart TTTTT) were proposed on January 22, 2003; promulgated on October 10, 2003; and amended on April 20, 2006. These regulations apply to existing and new facilities that perform primary magnesium refining where the total hazardous air pollutants (HAPs) emitted are greater than, or equal to, 10 tons per year for each HAP, or where the total HAPs emitted are greater than, or equal to, 25 tons per year of any combination of HAPs. New facilities include those that commenced either construction or reconstruction after the date of proposal. This information is being collected to assure compliance with 40 CFR part 63, subpart TTTTT. 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 the NESHAP.

Form Numbers: None.

Respondents/affected entities: Primary magnesium refining facilities.

Respondent's obligation to respond: Mandatory 40 CFR 63, Subpart TTTTT.

Estimated number of respondents: One (total).

Frequency of response: Semiannually.

Total estimated burden: 972 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $116,000 (per year), which includes $1,200 in annualized capital/startup and/or operation & maintenance costs.

Changes in the Estimates: There is an adjustment increase in the total estimated burden as currently identified in the OMB Inventory of Approved Burdens. This increase is not due to any program changes. The burden in this ICR has been adjusted to account for more accurate estimates for performance testing costs based on consultations with industry. The previous ICR assumed that a single performance test was conducted once every three years by the affected facility. This ICR adjusts the performance testing costs to reflect that the facility conducts separate performance tests for individual units during the term of the ICR. The regulation, 40 CFR 63.9912, requires performance testing no less frequently than twice (at mid-term and renewal) of each term of the Title V permit, or every 2.5 years, for each emission point. For the facility subject to this rule, we have clarified that multiple emission points must be tested twice during the Title V permit term, with approximately 20 percent of units anticipated to require a retest. This ICR therefore assumes that performance tests are conducted for approximately two emission units in each year during the three-year period of this ICR. Therefore, labor costs have been adjusted to account for submission of notification and reports for performance tests twice annually. This change also results in an increase in the number of responses.

The CAA affords the EPA a 45-day period to review and object to, as appropriate, operating permits proposed by state permitting authorities under title V of the CAA. Section 505(b)(2) of the CAA authorizes any person to petition the EPA Administrator to object to a title V operating permit within 60 days after the expiration of the EPA's 45-day review period if the EPA has not objected on its own initiative. Petitions must be based only on objections to the permit that were raised with reasonable specificity during the public comment period provided by the state, unless the petitioner demonstrates that it was impracticable to raise these issues during the comment period or unless the grounds for the issue arose after this period.

The EPA received the Petition from the Environmental Integrity Project, Sierra Club, Coastal Alliance to Protect our Environment, and Texas Campaign for the Environment dated February 24, 2021, requesting that the EPA object to the issuance of operating permit no. O4169, issued by TCEQ to the Olefins, Derivative, and Utilities Plant in San Patricio County, Texas. The Petition claims the proposed permit was issued before GCGV complied with applicable public participation requirements and fails to include and assure compliance with all applicable requirements.

On May 12, 2022, the EPA Administrator issued an Order granting in part and denying in part the Petition. The Order explains the basis for the EPA's decision.

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 http://www.epa.gov/dockets.

Abstract: Pursuant to section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA), 42 U.S.C. 11001 et seq., certain facilities that manufacture, process, or otherwise use specified toxic chemicals in amounts above reporting threshold levels as provided in 40 CFR 372.25 must submit annually to EPA reporting forms to the Toxics Release Inventory (TRI). The revisions to this ICR covers the information collection activities associated with the submission of information to TRI pursuant to EPCRA section 313(b)(2), 42 U.S.C. 11023. Under EPCRA section 313(b)(2), the EPA Administrator has the authority to extend TRI reporting requirements to specific facilities that manufacture, process, or otherwise use a TRI-listed toxic chemical, but who are not currently covered by TRI reporting requirements as described at 40 CFR 372. The Administrator may determine a specific facility warrants TRI reporting on the basis of a chemical's toxicity, the facility's proximity to other facilities that release the chemical or to population centers, the facility's history of releases of the chemical, or other factors that the Administrator deems appropriate. This ICR revision includes discussion of EPA's discretionary authority under EPCRA section 313(b)(2) and outreach to potential stakeholders.

Form Numbers: 9350-1 and 9350-2.

Respondents/affected entities: The facility has 10 or more full-time employee equivalents; the facility is included in a NAICS Code listed at 40 CFR 372.23 or under E.O. 13148, Federal facilities regardless of their industry classification; and the facility manufactures (defined to include importing), processes, or otherwise uses any EPCRA section 313 (TRI) chemical in quantities greater than the established thresholds for the specific chemical in the course of a calendar year. EPA may also exercise its discretionary authority under EPCRA section 313(b)(2) to extend TRI reporting obligations to a facility.

Respondent's obligation to respond: Mandatory, 40 CFR 372 and EPCRA section 313.

Estimated number of respondents: 76,579 (total).

Frequency of response: Annual.

Total estimated burden: 3,616,827 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $257,011,726 (per year), includes no annualized capital or operation & maintenance costs.

Changes in the estimates: There is an increase of 1700 hours in the total estimated respondent burden compared with the ICR currently approved by OMB. The additional hours are a result of an increase in 3 burden hours per facility in non-reporting burden. This increase also reflects the review of the notification and preparation of responses stakeholders may engage in upon receipt of the Agency's notification of its potential application of the discretionary authority under EPCRA section 313(b)(2) to specific facilities. This increase is categorized as a program change. Additionally, in December 2021, the EPA Administrator determined that 29 facilities warrant the extension of TRI reporting requirements under the authority in EPCRA section 313(b)(2) for specific chemicals; the updated burden estimates reflect potential reporting from these facilities.

EPA created a Privacy Act system of records to allow the Agency to maintain and readily access records to provide project and program managers the ability to plan, manage, track, and report on clean-up and enforcement activities taking place at Superfund sites. The SEMS database application supports the electronic capture, imaging, indexing, and tracking of records which document investigation, cleanup, and enforcement activities at potential and existing hazardous waste sites. The electronic repository of documents is routinely used in a variety of ways, including research, enforcement, litigation support, responses to congressional and Freedom of Information Act (FOIA) requests, public participation in the Superfund process, electronic archiving, cost recovery, disaster recovery, and support of the program and Agency missions. This notification confirms that the SEMS database may now also be used to house and manage documents developed by non-Superfund EPA program offices, including those conducting investigatory and enforcement activities under the Resource Conservation and Recovery Act, the Safe Drinking Water Act, the Clean Air Act, and the Federal Water Pollution Control Act.

Records protected under the Privacy Act are subject to Agency-wide security requirements governing all database systems at EPA. Privacy is maintained by limiting access to the database containing confidential business and personal information. Access to the database has been limited to individuals designated as system Administrators, Remedial Project Managers (RPMs), Data Sponsors, On-Scene Coordinators (OSCs), Information Management Coordinators (IMCs), Budget Coordinators (BCs), Regional Attorneys, Regional Managers, Data Entry Support Staff, Support Contractors, and any other staff with assigned data management responsibilities. This notification confirms that access to utilize and access the documents in the SEMS database may now be expanded to also include individuals holding comparable positions (including enforcement program staff) in EPA offices conducting investigatory and enforcement activities under the Resource Conservation and Recovery Act, the Safe Drinking Water Act, the Clean Air Act, and the Federal Water Pollution Control Act. This notification further clarifies and specifies categories of records that may be present in the SEMS database.

EPA is adding General Routine Use B related to the disclosure of information to sources from which additional information is requested and a General Routine Use D related to disclosure of information to the Office of Management and Budget (OMB). Additionally, EPA is modifying General Routine Use L and adding General Routine Use M regarding response to a suspected or confirmed breach of personally identifiable information. EPA is also modifying SEMS to add three Specific Routine Uses that may include disclosure to appropriate Federal, state, local, and tribal authorities in conformity with Federal, state, local, and tribal laws when necessary to protect the environment or public health or safety, including effectively carrying out an investigation or response. Information sharing agreements may be used as a mechanism to define appropriate limitations on use and disclosure of Privacy Act information by state, tribal, and local officials. Information may also be shared with state agencies and with the public as part of their participation in the Superfund evaluation and decision-making process. This may include public disclosure of addresses where EPA determines cleanup actions are required. In cases of emergency, EPA may share information with members of the public to assure protection of the environment or public health and safety. Records may be disseminated in response to other external requests, and in support of investigation; cleanup; program planning; community outreach; coordination with state, local and tribal entities; listing and de-listing of Superfund sites; enforcement activities; and litigation.

A. Purpose

The General Services Administration Acquisition Regulation (GSAR) clause 552.238-82, Modifications (Federal Supply Schedule), which was previously titled and numbered as 552.238-81 Modifications (see 84 FR 17030 dated April 23, 2019), requires Contractors who have a GSA Federal Supply Schedule (FSS) contract to request a contract modification by submitting information to the contracting officer. The clause covers the following types of contract modification requests: additional items/additional SINs, deletions, and price reductions. At a minimum, each contract modification request covered by this clause is to include an explanation for the request and supporting information.

Respondents: 14,200.

Responses per Respondent: 1.

Total Responses: 14,200.

Hours per Response: 3.5.

Total Burden Hours: 49,700.

A 60-day notice published in the Federal Register at 87 FR 19936 on April 6, 2022. No comments were received.

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. Please cite OMB Control No. 3090-0302, “Modifications (Federal Supply Schedule)” in all correspondence.

Proposed Project Measure Dx: A Resource To Identify, Analyze, and Learn From Diagnostic Safety Events

The Measure Dx resource (the Resource) is a modular toolkit that provides clinicians, quality and safety personnel, and healthcare organization leaders with guidance for implementing diagnostic safety measurement strategies for the purposes of learning and improvement. The Resource was developed and pilot tested (Fast Track OMB control number: 0935-0179) during the base year of an AHRQ contract awarded to the MedStar Health Research Institute and provides pragmatic recommendations for implementing measurement strategies that were identified in the AHRQ Issue Brief titled Operational Measurement of Diagnostic Safety: State of the Science. In particular, the Resource focuses on four broad measurement strategies that were assessed to be approaching readiness for implementation in operational settings.

AHRQ is requesting full OMB approval to conduct a formal evaluation of the Resource. AHRQ would like to further develop this resource, expanding on the initial pilot test which qualitatively examined feasibility of implementing the resource, general receptivity, and feedback for improvement.

This information collection has the following goal:

1. To evaluate the Resource in order to stimulate measurement activities for learning and improvement and quantitatively and qualitatively examine:

a. Feasibility of implementing the Resource with limited to no technical assistance;

b. User experience and satisfaction with the Resource;

c. Impact of the Resource on diagnostic safety policies or activities;

d. Yield of newly detected diagnostic safety events and associated learning resulting from use of the Resource;

e. Intent to sustain use of the Resource and continue with the diagnostic safety process following evaluation efforts.

This information collection is being conducted by AHRQ through its contractor, MedStar Health Research Institute, pursuant to AHRQ's statutory authority to conduct and support research on healthcare and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness and value of healthcare services and with respect to quality measurement and improvement. 42 U.S.C. 299a(a)(1) and (2).

To achieve the goals of this project the following information collection instruments will be completed:

(1) Organizational Characteristics Survey—designed to qualitatively describe the characteristics of the organizations engaged in evaluation ( e.g., patient characteristics, practice size, and staffing).

(2) Organizational Self-Assessment Survey—designed to qualitatively assess the organization's readiness ( e.g., leadership support, resources, and safety culture/infrastructure) for implementing the Resource.

(3) The Safer Dx Checklist—A synthesis of foundational practices that health care organizations can use to advance diagnostic excellence. The checklist provides a framework for organizations to conduct a self-assessment to understand the current state of diagnostic practices, identify areas to improve, and track progress toward diagnostic excellence over time.

(4) Pre-test Evaluation Interview Protocol—designed to qualitatively assess the organization's current policies and structures related to diagnostic safety, plans for implementing the Resource, and initial feedback on resource materials.

(5) Post-test Evaluation Interview Protocol—designed to qualitatively assess the organization's experience with implementing the Resource, the impact of the Resource on diagnostic safety policies or activities in their organization, contextual information about whether and how the Resource facilitated case detection, and intent to sustain use of the Resource following evaluation efforts.

(6) Team Questionnaire—adapted to help organizations self-assess diagnostic teamwork in their organization & their diagnostic team's commitment to implementing the Resource.

(7) Case Review Summary Form—designed to quantitatively and qualitatively summarize the diagnostic safety intelligence that participants have detected, analyzed, and/or learned from while implementing one Measure Dx strategy.

(8) ECHO Calls Protocol—The purpose of virtual ECHO calls is to foster bi-directional learning among the participating organizations, to check site progress during the implementation period and to understand “real-time” challenges, successes, and lessons learned. Standard questions for each ECHO session will be asked to foster shared learning and discussion. AHRQ will use the information collected to assess and enhance the feasibility of organizations in adopting the Resource to stimulate diagnostic safety measurement activities for learning and improvement. AHRQ's ability to publicly share a diagnostic measurement resource that has been scientifically validated is expected to be of great interest to the health care community and important in helping organizations measure diagnostic safety for patient safety and quality improvement efforts.

In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, comments on AHRQ's information collection are requested with regard to any of the following: (a) whether the proposed collection of information is necessary for the proper performance of AHRQ's health care research and health care information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.

The Order was one of several actions taken by the Federal government during earlier phases of the COVID-19 pandemic to help mitigate the further transmission and spread of SARS-CoV-2 variants into and within the United States. Since then, many circumstances have changed, including the widespread uptake of effective COVID-19 vaccines and accompanying vaccine- and infection-induced immunity, as well as the availability of effective therapeutics, and CDC remains focused on preventing medically significant disease, hospitalizations, and deaths from COVID-19. Accordingly, CDC has determined that it is not currently necessary to leave the Order in place to prevent introduction of currently circulating SARS-CoV-2 variants into the United States.

CDC continues to recommend that all travelers remain up to date with vaccination against COVID-19 and get tested for current infection with a viral test before and after they travel, and after any known exposure to a person with COVID-19, so they can take appropriate precautions to reduce the risk of exposing others while infectious. Furthermore, CDC continues to recommend that people wear masks in indoor public transportation settings.

In accordance with this Rescission Order, the Passenger Disclosure and Attestation form (OMB Control No. 0920-1318) has been amended to remove the testing requirement. CDC will publish a separate notice regarding this change under the Paperwork Reduction Act.

A copy of the Order is provided below, and a copy of the signed Order can be found at https://www.cdc.gov/quarantine/pdf/rescission-global-testing-order-p.pdf.pdf.

On January 26, 2021, the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), issued an Order titled, “Requirement for Negative Pre-Departure COVID-19 Test Result or Documentation of Recovery from COVID-19 for All Airline or Other Aircraft Passengers Arriving Into the United States From Any Foreign Country.” 86 FR 7387 (Jan. 28, 2021). As subsequently amended, the Order currently requires all air passengers, 2 years or older, traveling to the United States from a foreign country to present a negative COVID-19 test result from a sample taken no more than one day before departure, or documentation of recovery from COVID-19 in the past 90 days, before boarding a flight. 86 FR 69256 (Dec. 7, 2021). 1

The Order was one of several actions taken by the Federal government during earlier phases of the COVID-19 pandemic to help mitigate the further transmission and spread of SARS-CoV-2 variants into and within the United States. At that time, CDC concluded that it was a reasonable and necessary measure in light of the increased risk of transmission and spread of SARS-CoV-2 variants by international air travel into the United States, as well as the low rate of vaccination and infection-induced immunity in the United States, and emergence of new variants of concern. Indeed, when the Order was last amended, it identified the Omicron variant as a variant of concern, noting uncertainty about how easily that variant might spread, the severity of disease it might cause, and the level of protection against it that vaccines might afford. 86 FR at 69259-60.

Since then, many circumstances have changed, including the widespread uptake of effective COVID-19 vaccines and accompanying vaccine- and infection-induced immunity, as well as the availability of effective therapeutics. However, CDC remains focused on preventing medically significant disease, hospitalizations, and deaths from COVID-19. CDC has determined that it is not currently necessary to leave the Order in place to prevent introduction of currently circulating SARS-CoV-2 variants into the United States. In its place, CDC has determined that travelers have access to tools ( e.g., vaccines, therapeutics, and recommended prevention measures) and guidance that allow travelers to make informed choices about the use of pre-departure testing and other prevention measures. CDC continues to recommend that all travelers remain up to date with vaccination against COVID-19 and get tested for current infection with a viral test before and after they travel, and after any known exposure to a person with COVID-19, so they can take appropriate precautions to reduce the risk of exposing others while infectious.

CDC monitors circulating SARS-CoV-2 variants around the world and can enhance prevention measures, including reinstituting testing requirements, as warranted, including if a variant emerges that may present increased risk of severe illness and death. Removing this requirement is consistent with the framework CDC released in February 2022, “COVID-19 Community Levels,” reflecting public health's focus on reducing medically significant disease, hospitalization, and deaths. 2

The single-source award will provide high quality prevention, care, and treatment services for PLHIV; strengthen strategic health information; and provide equitable access to comprehensive public health services addressing PLHIV and other diseases impacting PLHIV in TT.

The Ministry of Health is in a unique position to conduct this work, as it is the national authority charged with oversight of the entire health system in TT. The HIV and AIDS Coordinating Unit (HACU) in the MOH leads the Ministry of Health's response in reducing the incidence of HIV infections in TT and mitigating the impact of HIV/AIDS in persons infected and affected nationwide.

Recipient: Ministry of Health (MOH)—Trinidad & Tobago (TT).

Purpose of the Award: The purpose of the award is to help build national capacity of TT to treat HIV and other diseases of public health importance impacting PLHIV and populations affected by HIV, as well as move progress towards achieving the 95-95-95 goals and ensure sustainable control of the epidemic in TT.

Amount of Award: The approximate year 1 funding amount will be $2,000,000 in Federal Fiscal Year (FYY) 2022 funds, subject to the availability of funds. Funding amounts for years 2-5 will be set at continuation.

Authority: This program is authorized under Public Law 108-25 (the United States Leadership Against HIV AIDS, Tuberculosis and Malaria Act of 2003).

Period of Performance: September 30, 2022, through September 29, 2027.

The single-source award will allow ZNPHI to implement effective surveillance, laboratory, response, and capacity building functions to enhance the well-being of people in Zambia. ZNPHI will efficiently manage its responsibilities through transparent and data-driven decision making, robust organizational capacities, and effective internal/external stakeholder communication. ZNPHI will also work with other government of Zambia entities to implement public health strengthening activities. Likewise, ZNPHI will work with other National Public Health Institutes or Ministries of Health in the region to develop or strengthen their public health capacities and functions.

Zambia National Public Health Institute is in a unique position to conduct this work. ZNPHI was established in 2015 and operated under MOH authorities for several years. During this time, they have been funded by the Zambian government and other partners. The ZNPHI Act was passed in 2020, which officially established ZNPHI as an independent agency and the main institution responsible for public health and the national focal point for implementation of the International Health Regulations. ZNPHI's mandate also includes responsibility for the health security for the nation through the establishment and functioning of the public health emergency operations center; national public health laboratory; surveillance; workforce development and through the coordination of public and global health security.

Recipient: Zambia National Public Health Institute (ZNPHI).

Purpose of the Award: The purpose of this award is to strengthen ZNPHIs' public health capacity and to support ZNPHI to work with countries to build strong National Public Health Institutes in the region. The CDC seeks to strengthen NPHIs that are credible, technically expert, and prioritize the protection of the public's health.

Amount of Award: $10,000,000 in Federal Fiscal Year (FFY) 2022 funds, with a total estimated $50,000,000 for the 5-year period of performance, subject to availability of funds. Please note, this NOFO funding strategy is as follows: $2,000,000 for Core Component 1, and $8,000,000 in Approved but Unfunded (ABU) Components.

Authority: This program is authorized under Section 307 of the Public Health Service Act [42 U.S.C. 242 I ] and Section 301(a) [42 U.S.C. 241(a)] of the Public Health Service Act.

Period of Performance: September 30, 2022, through September 29, 2027.

The single-source awards will continue support to strengthening cooperation with and capacity of the India Council of Medical Research (ICMR) institutions to prevent avoidable epidemics, early detection of disease threats, and rapid and effective response.

India Council of Medical Research is in a unique position to conduct this work, as it was originally established as an apex body for the formulation, coordination, and promotion of biomedical research in India, and has taken up most of the laboratory-based surveillance of infectious diseases in recent years. Eligibility for funding is limited to the ICMR, New Delhi and ICMR institutions including the National Institute of Virology (NIV), Pune and the National Institute of Epidemiology (NIE), Chennai. ICMR is the apex governing body for the numerous national level institutes which are centres for excellence and reference in specific scientific area for India, namely National Institute of Virology, National Institute of Epidemiology, and several others. These institutions are mandated by the Ministry of Health of Family Health and Welfare (MoHFW) to provide oversight for laboratory confirmation of priority pathogens in India in a tiered manner as well as collate and analyze surveillance data for public health actions and work closely with the state governments where these institutes are located.

Recipient: India Council of Medical Research (IMCR), New Delhi and ICMR institutions: National Institute of Virology (NIV), Pune and National Institute of Epidemiology (NIE), Chennai.

Purpose of the Award: The purpose of these awards is to accelerate progress toward an India safe and secure from infectious disease threats through ICMR institutions' focus on emerging and re-emerging pathogens, including detecting, and controlling zoonotic disease outbreaks through a One Health approach; evaluating vaccine safety monitoring systems; capacitating the public health workforce in field epidemiology and outbreak response; and combating antimicrobial resistance. These GHS strategies will result in outcomes that will strengthen the Indian public health system; decrease morbidity and mortality; and improve pandemic and epidemic preparedness and response.

Amount of Award: $8,165,000 in Federal Fiscal Year (FFY) 2022 funds per institution, with a total estimated $122,475,0000 for the 5-year period of performance, subject to availability of funds. Please note, the NOFO funding strategy is as follows: $660,000 for Core Component 1, and $7,505,000 in Approved but Unfunded (ABU) Components for each recipient.

Authority: This program is authorized under Section 307 of the Public Health Service Act [42 U.S.C. 242 I ] and Section 301(a) [42 U.S.C. 241(a)] of the Public Health Service Act.

Period of Performance: September 30, 2022, through September 29, 2027.

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

This information collection supports FDA regulations regarding the sanitary transportation of human and animal food. The regulations are intended to focus on preventing food safety problems throughout the food chain and were issued under the Sanitary Food Transportation Act of 2005 (2005 SFTA), and the FDA Food Safety Modernization Act, enacted in 2011. The 2005 SFTA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act), in part, by creating section 416 (21 U.S.C. 350e), which directs us to issue regulations to require shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use prescribed sanitary transportation practices to ensure that food is not transported under conditions that may render the food adulterated. Section 416 of the FD&C Act also directs that we prescribe appropriate human and animal food transportation practice requirements relating to: (1) sanitation; (2) packaging, isolation, and other protective measures; (3) limitations on the use of vehicles; (4) information to be disclosed to carriers and to manufacturers; and (5) recordkeeping.

In addition, the 2005 SFTA created section 402(i) of the FD&C Act (21 U.S.C. 342(i)), which provides that food that is transported or offered for transport by a shipper, carrier by motor vehicle or rail vehicle, receiver, or any other person engaged in the transportation of food under conditions that are not in compliance with the regulations issued under section 416 is adulterated and section 301(hh) of the FD&C Act (21 U.S.C. 331(hh)), which prohibits the failure by a shipper, carrier by motor vehicle or rail vehicle, receiver, or any other person engaged in the transportation of food to comply with the regulations issued under section 416 of the FD&C Act.

The 2005 SFTA also amended section 703 of the FD&C Act (21 U.S.C. 373) by providing that a shipper, carrier by motor vehicle or rail vehicle, receiver, or other person subject to section 416 shall, on request of an officer or employee designated by FDA, permit the officer or employee, at reasonable times, to have access to and to copy all records that are required to be kept under the regulations issued under section 416 of the FD&C Act.

Accordingly, we issued regulations in 21 CFR part 1, subpart O (21 CFR 1.900 through 1.934) that establish requirements for the sanitary transportation of human and animal food, as well as prescribe procedures for respondents who wish to request a waiver for any requirement. For additional information regarding Agency implementation of the 2005 SFTA, visit our website at https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/sanitation-transportation-guidance-documents-regulatory-information.

In the Federal Register of February 24, 2022 (87 FR 10369), FDA published a 60-day notice requesting public comment on the proposed collection of information. Although one comment was received, it was not responsive to the information collection topics solicited.

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

We estimate an annual recordkeeping burden of 124,669, which assumes 1,502,032 workers will spend an average of 5 minutes on activities related to the record retention requirements under § 1.912. We expect these activities will likely include documenting procedures and training, as well as sanitary transportation operations and specification requirements.

We estimate one waiver petition from each of two firms will be submitted and respondents will spend 24 hours to prepare and submit the petition to FDA.

Finally, we estimate an annual third-party disclosure burden of 132 hours, assuming each of 226 firms will spend an average of 35 minutes, annually, disclosing written records as required under § 1.908.

Based on an evaluation of the information collection, we have made no adjustments to our burden estimate.

I. Background

FDA is announcing the availability of a guidance for industry entitled “Q9(R1) Quality Risk Management.” The guidance was prepared under the auspices of ICH. ICH has the mission of achieving greater regulatory harmonization worldwide to ensure that safe, effective, high-quality medicines are developed, registered, and maintained in the most resource-efficient manner.

By harmonizing the regulatory requirements in regions around the world, ICH guidelines have substantially reduced duplicative clinical studies, prevented unnecessary animal studies, standardized the reporting of important safety information, standardized marketing application submissions, and made many other improvements in the quality of global drug development and manufacturing and the products available to patients.

The six Founding Members of the ICH are the FDA; the Pharmaceutical Research and Manufacturers of America; the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; and the Japanese Pharmaceutical Manufacturers Association. The Standing Members of the ICH Association include Health Canada and Swissmedic. Additionally, the Membership of ICH has expanded to include other regulatory authorities and industry associations from around the world (refer to https://www.ich.org/ ).

ICH works by involving technical experts from both regulators and industry parties in detailed technical harmonization work and the application of a science-based approach to harmonization through a consensus-driven process that results in the development of ICH guidelines. The regulators around the world are committed to consistently adopting these consensus-based guidelines, realizing the benefits for patients and for industry.

As a Founding Regulatory Member of ICH, FDA plays a major role in the development of each of the ICH guidelines, which FDA then adopts and issues as guidance for industry. FDA's guidance documents do not establish legally enforceable responsibilities. Instead, they describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

In November 2021, the ICH Assembly endorsed the draft guideline entitled “Q9(R1) Quality Risk Management” and agreed that the guideline should be made available for public comment. The draft guideline is the product of the Quality Expert Working Group of the ICH. Comments about this draft guidance will be considered by FDA and the Quality Expert Working Group.

FDA is thus announcing the availability of a guidance for industry entitled “Q9(R1) Quality Risk Management.” The current Q9 guideline published in 2006 provides a common, harmonized framework for Quality Risk Management that can enable more effective and consistent risk-based decisions, both by regulators and industry, regarding the quality of drug substances and drug products across the product lifecycle. This draft guidance is a targeted revision that addresses four areas for improvement: (1) high levels of subjectivity in risk assessments and in QRM outputs; (2) product availability risks; (3) lack of understanding as to what constitutes formality in QRM work; and (4) lack of clarity on risk-based decision-making. The revisions are intended to update the original Q9 guideline based on implementation experience to promote improved lifecycle management of hazards and prevent defects, recalls, and shortages.

This draft guidance has been left in the original ICH format. The final guidance will be reformatted and edited to conform with FDA's good guidance practices regulation (21 CFR 10.115) and style before publication. The draft guidance, when finalized, will represent the current thinking of FDA on “Q9(R1) Quality Risk Management.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collection of information in 21 CFR part 211 has been approved under OMB control number 0910-0139.

Persons with access to the internet may obtain the draft guidance at https://www.regulations.gov, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.fda.gov/regulatory-information/search-fda-guidance-documents.

Authority and Purpose: Section 301 of the National Nutrition Monitoring and Related Research Act of 1990 (7 U.S.C. 5341) requires the Secretaries of HHS and USDA to publish the Dietary Guidelines for Americans ( Dietary Guidelines ) jointly at least every five years. The law instructs that this publication shall contain nutritional and dietary information and guidelines for the general public, shall be based on the preponderance of scientific and medical knowledge current at the time of publication, and shall be promoted by each federal agency in carrying out any federal food, nutrition, or health program. The current edition of the Dietary Guidelines (2020-2025) provides guidance on the entire life span, from birth to older adulthood, including pregnancy and lactation. The Dietary Guidelines for Americans, 2025-2030 will continue to provide food-based dietary guidance across the entire lifespan to help meet nutrient needs, promote health, and reduce the risk of chronic disease.

The 2025 Dietary Guidelines Advisory Committee (Committee) shall be formed and governed under the provisions of the Federal Advisory Committee Act (FACA), Public Law 92-463, as amended (5 U.S.C., App), which sets forth standards for the formation and use of advisory committees. The Committee is established to provide independent, evidence-based advice and recommendations to be considered by HHS and USDA in the Departments' development of the Dietary Guidelines for Americans, 2025-2030. The Committee's review and advice will focus on the scientific questions prioritized by HHS and USDA with the potential to inform nutrition guidance for Americans across the lifespan. Formation of the Committee is necessary to adequately review the science to inform the Dietary Guidelines and is in the public interest.

The Committee is expected to begin meeting in early 2023; the Committee will meet approximately five times during its operation. Pursuant to the FACA, all Committee meetings will be open to the public. The Committee will be established to accomplish a single, time-limited task. The Committee will develop a scientific report of its recommendations that will be submitted to the Secretaries of HHS and USDA. Upon delivery of its report to the Secretaries or when the Committee's charter expires two years after it is filed, the activities of the Committee will be terminated.

Structure: The Committee will consist of 15 to 20 members, including the Chair and Vice-Chairperson. Factors to be considered in selecting individuals to serve on the Committee include educational background, professional experience, and demonstrated scientific expertise in the issues to be examined by the Committee, as well as statutory obligations under FACA and desire for a balanced and diverse membership.

Expertise in human nutrition related to disease prevention and health promotion for the specific scientific topics identified by the Departments to be examined by the Committee will be sought. Expertise will also be sought related to health equity and the scientific approaches used to review the evidence (systematic reviews, food pattern modeling, and data analysis). Information on the scientific topics is available at www.dietaryguidelines.gov.

Equal opportunity practices regarding membership appointments to the Committee will be aligned with HHS and USDA policies. To the extent possible, HHS and USDA will ensure the Committee membership is balanced in expertise, experience, education, and institutional affiliation and is reflective of the racial, ethnic, gender, and geographic diversity within the United States.

Individuals will be appointed to serve as members of the Committee to evaluate the scientific evidence, not to represent the viewpoints of any specific group. Members of the Committee will be classified as Special Government Employees (SGE)s during their term of appointment and, as such, are subject to the ethical standards of conduct for federal employees. Upon entering the position and annually throughout the approximate 2-year term of appointment, members of the Committee will be required to complete and submit a report of their financial holdings.

Nominations and Appointments for Memberships: Nominees, including self-nominees, will be considered for appointment as members of the Committee. Only complete nomination packages submitted within the allotted time period will be considered. To be considered for an appointment, submission of the following information for each nominee is required: (1) a cover letter that clearly states the name and place of work of the nominee, the rationale for the nomination ( i.e., which specific topics they have expertise in, highlighting relevant experience in health equity and the scientific approaches used by the Committee, if applicable), and a statement that the nominee would be willing to serve as a member of the Committee, if selected; (2) the name, address, telephone number, and email address for the individual being nominated and the nominator, if applicable; and (3) a copy of the nominee's curriculum vitae, limited to no more than 15 pages.

The curriculum vitae should include the following information: (a) education; (b) experience (current and former); (c) affiliations (food, nutrition, public health, and/or other relevant associations, including positions held); (d) current memberships (expert panels, committees, or other relevant groups, including positions held); (e) peer-reviewed publications (for past 10 years); (f) oral presentations (for past 5 years); (g) editorials, opinion pieces, and blogs (for past 5 years); (h) grants, contracts, or research funding (for past 15 years); (i) name of any corporation, professional society, association, panel, company, firm, government agency (federal, state, and local), research organization, educational institution, committee, or other organization or institution (government, private, and not-for-profit; domestic and foreign) in which the nominee's services have been, will be, or are expected to be provided, with or without compensation, including on a part-time or seasonal basis as an officer, medical staff, board member, owner, trustee, director, expert advisor, consultant, official spokesperson, member of speakers bureau, or expert witness (for past 10 years and upcoming); (j) other paid travel or honoraria received, not included above (for past 5 years). If the nominee does not have anything to report for the section(s), indicate “none.” Web links to publications, presentations, and other materials available online are requested, when available.

Where prohibited by federal law or regulations, nominations will not be accepted directly from USDA research and promotion boards. Self-nominations and nominations by members of research and promotion boards in their individual capacity will be considered. Federal employees should not be nominated for consideration for appointment to this Committee.

This RFI is in accordance with the NIH Reform Act of 2006, 42 U.S.C. Sec. 282, as amended. Catalyzing and unifying the national ecosystem around pediatric medical devices will necessitate leveraging collective opportunities, such as through the formation of a multi-stakeholder Public Private Partnership (PPP) to address the existing challenges in development, optimization, and translation of pediatric medical devices.

Despite numerous legislative, regulatory, and scientific efforts of the recent past, there has been little change in the number of devices being developed, reviewed, and/or approved for use in the pediatric population in the United States. The cause of this public health problem is multifold:

• Real and perceived ethical considerations of carrying out trials in pediatric patients.

• The heterogeneous developmental range of children, from birth to 21 years.

• Lack of access to disease- and age-specific patient sets, and experienced clinical-trial infrastructure.

• Unclear regulatory pathways and financial environment ( i.e., unpredictable reimbursement).

• A lack of technical innovation for approaches to meet pediatric-specific needs.

• Lack of clear value proposition to device manufacturers and industry partners.

Such problems have caused difficulties such as off-label use of devices in children, often without clear instructions or with non-standard modifications that create further complications and risks. Additionally, many conditions for children that could be treated via a device are not pursued. Pediatric patients with serious or life-threatening diseases that are often in greatest need might only have access to an investigational medical device without an appropriate level of evidence.

NICHD and NIBIB seek information and actionable recommendations on research gaps, needs, best practices, innovative study designs and measurement, resources and data resources, and opportunities to inform a PPP to enhance pediatric medical devices space.

Specifically, respondents are asked to briefly address the following topics or categories in the context of Pediatric Medical Devices. Comments are strongly encouraged to address unique challenges of using pediatric medical devices on health disparity populations. NIH defines health disparity populations as racial and ethnic minority populations, less privileged socioeconomic status (SES) populations, underserved rural populations, sexual and gender minorities (SGM), and any subpopulations that can be characterized by two or more of these descriptions. For more information, please refer to NIH definition of Health Disparity ( https://www.nimhd.nih.gov/about/strategic-plan/nih-strategic-plan-definitions-and-parameters.html#:~:text=NIH%20defines%20health%20disparity%20populations,or%20more%20of%20these%20descriptions. )

(1) Potential partners to ensure success of public-private partnership to advance the national PMD ecosystem. Some of these challenges pertain, but are not limited to, involvement and integration of:

(a) Philanthropic and non-profit organizations.

(b) Patient advocacy groups.

(c) Primary care providers, specialists and clinicians, clinical trialists, and pediatric patients.

(d) Financial experts.

(e) Regulatory science experts to evaluate new and existing regulations in PMD.

(2) Involvement of Private Industry while considering factors such as:

(a) Small market size in pediatric medical devices being one of the key barriers for industry participation.

(b) Identifying approaches to de-risk development and commercialization of PMD.

(c) Federal efforts to assist further small companies.

(d) Overcoming manufacturing, clinical trials, logistical and regulatory burdens.

(e) Engineering and manufacturing challenges for evaluation of feasibility, validation and scale-up strategies of device prototype and relative costs.

(3) Priorities in Pediatric Medical Device innovation, research, and commercialization such as:

(a) Accelerating PMD Research & Development, including, but not limited to, point of care technologies in response to Health Emergencies.

(b) Specific preclinical and clinical research areas to enhance innovation in pediatric medical devices.

(c) Projects focusing on development of technologies based on specific disease, conditions, and patient population.

(d) Reduce off-label usage of adult medical devices for pediatric patients.

(e) Resources and support for innovators, small business concerns to enhance successful development and commercialization of PMD designed and tested for pediatric indications.

(f) Building inclusive, diverse, and transdisciplinary workforce. For more information on diverse workforce, please refer to the Notice of NIH's Interest in Diversity NOT-OD-20-031 ( https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-031.html. )

(4) Accountability measures to evaluate the program success in areas such as, but not limited to:

(a) Performance and accomplishment of public private partnership.

(b) Number of products and devices that obtain regulatory approval.

(c) Improvement of processes for PMD development and commercialization.

(5) Clinical Trial infrastructure, data sharing, and protocol standardization such as:

(a) Establishment of hospital-based and decentralized clinical trials networks to evaluate and validate new technologies and therapeutic devices.

(b) Issues pertaining to number of clinical sites.

(c) Patient reported outcomes.

(d) Challenges related to patient enrollment and limited dataset.

(e) Data science expertise, such as biostatistics, to address issues related to clinical trial database.

(f) Standardization of data and protocol integration across various health care settings.

(6) Reimbursement Challenges for Pediatric Medical Devices:

(a) Exploring reimbursement incentive strategies for Pediatric Medical Device innovators.

(b) Involvement of Federal agencies such as Centers for Medicare and Medicaid (CMS).

(c) Interaction with insurance companies during commercialization planning process.

(7) Any other topics which may be relevant for NIH to enhance the national pediatric medical device ecosystem via public-private partnership.

Responses to this RFI are voluntary and may be submitted anonymously. Please do not include any personally identifiable information or any information that you do not wish to make public. You may voluntarily include your name and contact information with your response. If you choose to provide NIH with this information, NIH will not share your name and contact information outside of NIH unless required by law. Proprietary, classified, confidential, or sensitive information should not be included in your response. The Government will use the information submitted in response to this RFI at its discretion. Other than your name and contact information, the Government reserves the right to use any submitted information on public websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements. This RFI is for informational and planning purposes only and is not a solicitation for applications or an obligation on the part of the Government to provide support for any ideas identified in response to it. Please note that the Government will not pay for the preparation of any information submitted or for use of that information.

The information collection notice was previously published in the Federal Register on March 30, 2022, at 87 FR 18378, allowing for a 60-day public comment period. USCIS did not receive any comments in connection with the 60-day notice.

You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at: http://www.regulations.gov and enter USCIS-2005-0024 in the search box. The comments submitted to USCIS via this method are visible to the Office of Management and Budget and comply with the requirements of 5 CFR 1320.12(c). All submissions will be posted, without change, to the Federal eRulemaking Portal at http://www.regulations.gov, and will include any personal information you provide. Therefore, submitting this information makes it public. You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make to DHS. DHS may withhold information provided in comments from public viewing that it determines may impact the privacy of an individual or is offensive. For additional information, please read the Privacy Act notice that is available via the link in the footer of http://www.regulations.gov.

Written comments and suggestions from the public and affected agencies 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 agency's 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: Biographic Information (for Deferred Action).

(3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection: G-325A; USCIS.

(4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Individuals or households. USCIS uses Form G-325A to collect biographic information from individuals requesting either military deferred action or non-military deferred action (other than deferred action based on DACA, Violence Against Women Act, A-3, G-5, and T and V nonimmigrant visas).

(5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: The estimated total number of respondents for the information collection G-325A is 1,550 and the estimated hour burden per response is 2.15 hours.

(6) An estimate of the total public burden (in hours) associated with the collection: The total estimated annual hour burden associated with this collection is 3,333 hours.

(7) An estimate of the total public burden (in cost) associated with the collection: The estimated total annual cost burden associated with this collection of information is $38,750.

Comments

The information collection notice was previously published in the Federal Register on March 30, 2022, at 87 FR 18227, allowing for a 60-day public comment period. USCIS did receive eight comments in connection with the 60-day notice.

You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at: http://www.regulations.gov and enter USCIS-2006-0025 in the search box. The comments submitted to USCIS via this method are visible to the Office of Management and Budget and comply with the requirements of 5 CFR 1320.12(c). All submissions will be posted, without change, to the Federal eRulemaking Portal at http://www.regulations.gov, and will include any personal information you provide. Therefore, submitting this information makes it public. You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make to DHS. DHS may withhold information provided in comments from public viewing that it determines may impact the privacy of an individual or is offensive. For additional information, please read the Privacy Act notice that is available via the link in the footer of http://www.regulations.gov.

Written comments and suggestions from the public and affected agencies 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 agency's 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 Request: Revision of a Currently Approved Collection.

(2) Title of the Form/Collection: Request for Premium Processing Service.

(3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection: I-907; USCIS.

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

Primary: Individuals or households. USCIS uses the data collected on this form to process a request for premium processing. The form serves the purpose of standardizing requests for premium processing and ensures that basic information required to assess eligibility is provided by the applicant or employer/petitioner.

(5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: The estimated total number of respondents for the information collection I-907 is 815,773 and the estimated hour burden per response is 0.58 hours.

(6) An estimate of the total public burden (in hours) associated with the collection: The total estimated annual hour burden associated with this collection is 473,148 hours.

(7) An estimate of the total public burden (in cost) associated with the collection: The estimated total annual cost burden associated with this collection of information is $202,923,534.

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): Revision of a Currently Approved Collection.

2. The Title of the Form/Collection: Limited Permittee Transaction Report.

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

Form number (if applicable): ATF Form 5400.4.

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: Individuals or households.

Other (if applicable): Business or other for-profit.

Abstract: The Limited Permittee Transaction Report—ATF Form 5400.4 is used to determine if limited permittees have exceeded the number of receipts of explosives materials they are allowed, as well as the eligibility of such persons to purchase explosive materials.

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 six times annually, and it will take each respondent approximately 20 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 200 hours, which is equal to 100 (total respondents) * 6 (# of response per respondent) * .333333 (20 minutes or the time taken to prepare each response).

7. An Explanation of the Change in Estimates: Due to fewer respondents, the total responses and burden hours were reduced by 50 and 150 hours respectively since the last renewal in 2019. The public cost burden for this information collection also reduced by $65 although the postage rate increased from 55 cents to 58 cents since 2019.

If additional information is required contact: Robert J. Houser, Assistant Director, Policy and Planning Staff, Office of the Chief Information Officer, United States Department of Justice, Justice Management Division, Two Constitution Square, 145 N Street NE, Mail Stop 3.E-206, 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 without Change of a Currently Approved Collection.

2. The Title of the Form/Collection: National Firearms Act (NFA) Responsible Person Questionnaire.

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

Form number (if applicable): ATF Form 5320.23.

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, Federal Government, State Local or Tribal Government.

Other (if applicable): Not-for-profit institutions and Farms.

Abstract: The National Firearms Act (NFA) Responsible Person Questionnaire—ATF Form 5320.23 (ATF Form 5320.23) must be completed by a responsible person (RP), identified as part of a trust or legal entity on the Application to Make and Register a Firearm—ATF Form 1 (5320.1) (ATF Form 1). This form must also be completed by a RP who is the identified as the firearm maker or the transferee on the Application for Tax Paid Transfer and Registration of Firearm—ATF Form 4 (5320.4) (ATF Form 4), or the Application for Tax Exempt Transfer of Firearm—ATF Form 5 (5320.5) ATF Form 5.

5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: An estimated 115,829 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 57,914.5 or 57,915 hours, which is equal to 115,829 (total respondents) * 1 (# of response per respondent) * .5 (30 minutes or the time taken to prepare each response).

If additional information is required contact: Robert J. Houser, Assistant Director, Policy and Planning Staff, Office of the Chief Information Officer, United States Department of Justice, Justice Management Division, Two Constitution Square, 145 N Street NE, Mail Stop 3.E-206, 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 without Change of a Currently Approved Collection.

2. The Title of the Form/Collection: Application for Tax Exempt Transfer and Registration of Firearm.

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

Form number (if applicable): ATF Form 5 (5320.5).

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: Federal Government and State, Local or Tribal Government.

Other (if applicable): Individuals or households, Business or other for-profit, Not-for-profit institutions, and Farms.

Abstract: The Application for Tax Exempt Transfer and Registration of Firearm—ATF Form 5 (5320.5) is used request permission to transfer and register a National Firearms Act (NFA) firearm, and to claim exemption from the transfer tax.

5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: An estimated 10,591 respondents will respond to this collection once annually, and it will take each respondent approximately 30.309 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 5,350 hours, which is equal to 10,591 (total respondents) * 1 (# of response per respondent) * .5052 hours (30.309 minutes or the time taken to prepare each response).

If additional information is required contact: Robert J. Houser, Assistant Director, Policy and Planning Staff, Office of the Chief Information Officer, United States Department of Justice, Justice Management Division, Two Constitution Square, 145 N Street NE, Mail Stop 3.E-206, 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 without Change of a Currently Approved Collection.

2. The Title of the Form/Collection: Application for Tax Paid Transfer and Registration of Firearm.

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

Form number (if applicable): ATF Form 4 (5320.4).

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: Individuals or households, Business or other for-profit, Federal Government, and State, Local, or Tribal Government.

Other (if applicable): Not-for-profit institutions, or Farms.

Abstract: The Application for Tax Paid Transfer and Registration of Firearm—ATF Form 4 (5320.4) must be completed to obtain permission to transfer and register a National Firearms Act (NFA) firearm. There is a tax of $5 or $200 on the transfer of an NFA firearm.

5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: An estimated 123,339 respondents will respond to this collection once annually, and it will take each respondent an average 3.7843261 hours 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 466,755 hours, which is equal to 123,339 (total respondents) * 1 (# of response per respondent) * 3.7843261(the total time taken to prepare each response).

If additional information is required contact: Robert J. Houser, Assistant Director, Policy and Planning Staff, Office of the Chief Information Officer, United States Department of Justice, Justice Management Division, Two Constitution Square, 145 N Street NE, Mail Stop 3.E-206, 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: Extension without Change of a Currently Approved Collection.

(2) The Title of the Form/Collection: Voluntary Magazine Questionnaire for Agencies/Entities That Store Explosive Materials.

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

Form number: 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: State, Local or Tribal Government.

Other: None.

Abstract: This information collection is used to identify the number and locations of public explosives storage facilities (magazines), which will enable Bureau of Alcohol, Tobacco, Firearms and Explosives personnel to respond properly to local emergencies such as natural disasters.

(5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: An estimated 1,000 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 500 hours, which is equal to 1,000 (total respondents) * 1 (# of response per respondent) * .5 (30 minutes or the time taken to prepare each response).

If additional information is required contact: Robert J. Houser, Assistant Director, Policy and Planning Staff, Office of the Chief Information Officer, United States Department of Justice, Justice Management Division, Two Constitution Square, 145 N Street NE, Mail Stop 3.E-206, 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:

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: Records of Acquisition and Disposition, Collectors of Firearms.

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

Form number: 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: Individuals or households.

Abstract: This information collection is a recordkeeping requirement that allows Bureau of Alcohol, Tobacco, Firearms and Explosives personnel to inquire about acquisition and disposition (A&D) records for firearms, during the course of criminal investigations or government compliance inspections.

(5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: An estimated 114,001 respondents will prepare records for this collection once annually, and it will take each respondent approximately 3.05 hours 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 347,703 hours, which is equal to 114,001 (total respondents) * 1 (# of response per respondent) * 3.05 hours (the total time taken to prepare each response).

(7) An Explanation of the Change in Estimates: The adjustment associated with this collection includes an increase in the total respondents and responses by 62,025, due to the addition of Type 01/02 firearms dealers and Type 03 firearms collectors. Consequently, the total burden hours have also increased by 189,176 since the last renewal in 2020.

If additional information is required contact: Robert J. Houser, Assistant Director, Policy and Planning Staff, Office of the Chief Information Officer, United States Department of Justice, Justice Management Division, Two Constitution Square, 145 N Street NE, Mail Stop 3.E-206, Washington, DC 20530.

The Occupational Safety and Health Act of 1970 (OSHA Act) (29 U.S.C. 651 et seq. ) authorizes information collection by employers as necessary or appropriate for enforcement of the OSH Act, or for developing information regarding the causes and prevention of occupational injuries, illnesses, and accidents (29 U.S.C. 657). The OSH Act also requires that OSHA obtain such information with minimum burden upon employers, especially those operating small businesses, and to reduce to the maximum extent feasible unnecessary duplication of efforts in obtaining information (29 U.S.C. 657).

The information collection requirements in the Inorganic Arsenic Standard provide protection for workers from the adverse health effects associated with exposure to inorganic arsenic. The Inorganic Arsenic Standard requires employers to: Monitor workers' exposure to inorganic arsenic, and notify workers of exposure-monitoring results; establish, implement, and update at least annually a written compliance program to reduce exposures to or below the permissible exposure limit by means of engineering and work practice controls; notify anyone who cleans protective clothing or equipment of the potentially harmful effects of inorganic arsenic exposure; develop, update, and maintain a housekeeping and maintenance plan; monitor worker health by providing medical surveillance; post warning signs, and apply labels to shipping and storage containers of inorganic arsenic; develop and maintain worker exposure monitoring and medical records; and provide workers with information about their exposures and the health effects of exposure to inorganic arsenic. For additional substantive information about this ICR, see the related notice published in the Federal Register on March 7, 2022 (87 FR 12738).

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-OSHA.

Title of Collection: Inorganic Arsenic Standard.

OMB Control Number: 1218-0104.

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

Total Estimated Number of Respondents: 494.

Total Estimated Number of Responses: 17,451.

Total Estimated Annual Time Burden: 10,430 hours.

Total Estimated Annual Other Costs Burden: $1,120,896.

Each operator of a surface coal mine is required under 30 CFR 77.1000 to establish and follow a ground control plan that is consistent with prudent engineering design and which will ensure safe working conditions. The mine operator is required by § 77.1000-1 to file the ground control plan under § 77.1000 for highwalls, pits and spoil banks with the appropriate District Manager. The mining methods employed by the operator are selected to ensure highwall, pit, and spoil bank stability. In the event of a highwall failure or material dislodgment, there may be very little time to escape possible injury; therefore, preventive measures must be taken. Each plan is based on the type of strata expected to be encountered, the height and angle of highwalls and spoil banks, and the equipment to be used at the mine. The plan is used to show how the mine operator will maintain safe conditions around the highwalls, pits, and spoil banks. Each plan is reviewed by MSHA to ensure that highwalls, pits, and spoil banks are maintained in a safe condition with sound engineering design.

For additional substantive information about this ICR, see the related notice published in the Federal Register on January 26, 2022 (87 FR 4047).

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-MSHA.

Title of Collection: Ground Control Plans for Surface Coal Mines and Surface Work Areas of Underground Coal Mines.

OMB Control Number: 1219-0026.

Affected Public: Businesses or other for-profits institutions.

Total Estimated Number of Respondents: 287.

Total Estimated Number of Responses: 287.

Total Estimated Annual Time Burden: 1,962 hours.

Total Estimated Annual Other Costs Burden: $545.

President Obama signed Executive Order 13496 (E.O. 13496) on January 30, 2009, requiring certain Government contractors and subcontractors to post notices informing their employees of their rights as employees under Federal labor laws. The regulatory provisions implementing E.O. 13496 (29 CFR part 471) include the language of the required notices, and they explain posting and contractual requirements, the complaint process, the investigatory process, and sanctions, penalties, and remedies that may be imposed if the contractor or subcontractor fails to comply with its obligations under the Order. Specifically, 29 CFR part 471.11 provides for the Department's acceptance of written complaints alleging that a contractor doing business with the Federal government has failed to post the notice required by this rule. For additional substantive information about this ICR, see the related notice published in the Federal Register on March 30, 2022 (87 FR 18397).

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-OLMS.

Title of Collection: Notice of Employee Rights under National Labor Relations Act Complaint Process.

OMB Control Number: 1245-0004.

Affected Public: Individuals or Households.

Total Estimated Number of Respondents: 10.

Total Estimated Number of Responses: 10.

Total Estimated Annual Time Burden: 13 hours.

Total Estimated Annual Other Costs Burden: $6.

The Department of Labor (Department) is committed to fostering a strong, open data policy that provides simple and meaningful public access to data, in formats that are most useful for public consumption and analyses of the data. The Department's open data policy must also comply with the law, including protecting personal and private information subject to the Privacy Act. The Department's open data policy is also consistent with Secretary's Order (SO) 02-2019, 1 the Federal Data Strategy, 2 and the Foundations for Evidence-Based Policymaking Act of 2018 (Evidence Act). 3

SO 02-2019 provides the Department's framework for building data capacity and includes the following requirements:

• Identify the critical role that data play in informing and influencing how the Department carries out its mission, and acknowledge that these data need to be leveraged, housed, described and documented, formatted, and made public in an optimal manner;

• Formalize the Data Board as the Department's data governance body, and as a forum to work across organizational lines to collaborate and coordinate effectively on data strategy, management, and policy issues, as well as data governance, stewardship, architecture, and utilization;

• Provide Departmental programs with clear descriptions of the motivation, context, and values associated with data governance and data strategy by linking evidence-based policymaking with the need for modern data infrastructure and strengthened data capacity; and

• Task the Data Board and the Chief Data Officer with serving the needs of the Department and its stakeholders to focus on the quality, consistency, and availability of data.

In addition, the Evidence Act and the recently published Federal Data Strategy have expanded the requirements for Federal agencies to build data capacity that benefits the public and to be transparent with their data assets. Examples of these expansions include Section 303 of the Evidence Act, which expands requirements for access to data for evidence and adds a presumption of accessibility to data, and Section 202(b) of the Evidence Act, which includes guidance to make data open by default. In similar fashion, the Federal Data Strategy explicitly calls on agencies to identify priority data sets (Action 1) and to identify their initial list of priority data assets for agency open data plans (Action 5).

Consistent with all of these requirements, the Department is building capacity for open data through the development of a new Application Programming Interface (API), and plans to provide open data through a data-as-a-service (DAAS) model. This model is expected to offer efficient, on-demand methods that enable users to create customized data extracts in a machine-readable format. The Department is also seeking to increase the quantity and types of data sets offered through DAAS, providing more standardized data documentation in electronic formats—including machine-readable—and designing a central portal for customers to find data, metadata, tools for ingesting data, and data-specific documentation.

The Department seeks public comment on specific approaches that could lead to wider and easier access, greater utility, and increased comprehensibility to data and associated documentation that the Department makes available. The Department also seeks comment on challenges with using existing Department data, 4 including access mechanisms, so that the Data Board and various Departmental programs can work to make improvements. Respondents should note that this request for comments does not address data products designed, collected, and published by the Bureau of Labor Statistics.

The Department seeks comments on the specific characteristics of data and supporting materials that would allow the public to better use and benefit from our open data. Examples may include:

1. Data content and format;

2. Data documentation, including metadata content, codebooks, and data dictionaries;

3. Data formats specific to certain analysis patterns ( e.g., spatial analysis, machine learning, and program evaluation) including tagging, geocoding, and data encoding that reduce burdens and increase efficiency;

4. Data quality issues that diminish the benefit and utility of Departmental data and limit transparency and analyses; and

5. Challenges with data comparability including linking across program data, establishing common identifiers across data sets, and merging Departmental data with other Federal and non-Federal data sources.

The Department also solicits public comment on the following areas:

6. Identifying data sets that are currently useful and merit prioritization in forthcoming open data efforts;

7. Identifying data sets that are neither public nor available through restricted-use access programs that could provide value to the Department's stakeholders if made available;

8. The relative advantages and disadvantages of various machine-readable formats including JavaScript Object Notation (JSON), Extensible Markup Language (XML), and ASCII text files with or without comma-separated values (CSV) files;

9. The relative advantages and disadvantages of providing open data through DAAS vis-a-vis complexity, efficiency, convenience, automation, and user-friendliness;

10. Specific data sets and methodologies that would be useful in achieving the goals of President Biden's Executive Orders on Equity from January 2021 and on Customer Experience from November 2021; and relevant data and metadata standards that enhance interoperability, promote transparency, aid discovery, provide understanding, and facilitate integrating data from multiple sources.

Respondents are encouraged to associate the category numbering above within their responses to facilitate organization and analysis of the comments.

I. Background: The Davis-Bacon Act (DBA), as enacted in 1931 and subsequently amended, requires the payment of minimum prevailing wages determined by the Department of Labor to laborers and mechanics working on federal contracts in excess of $2,000 for the construction, alteration, or repair, including painting and decorating, of public buildings and public works. See 40 U.S.C. 3141 et seq. Congress has also included the Davis-Bacon requirements in numerous other laws, known as the Davis-Bacon Related Acts (the Related Acts and, collectively with the Davis-Bacon Act, the DBRA), which provide federal assistance for construction projects through grants, loans, loan guarantees, insurance, and other methods.

The DBA delegates to the Secretary of Labor the responsibility to determine the wage rates that are “prevailing” for each classification of covered laborers and mechanics on similar projects “in the civil subdivision of the State in which the work is to be performed.” 40 U.S.C. 3142(b). The Administrator of the Wage and Hour Division, through this delegation of authority, is responsible for issuing these wage determinations (WDs). The DBA implementing regulations provide that, for the purpose of making WDs, the Administrator will conduct a continuing program for obtaining and compiling wage rate information. 29 CFR 1.3. As part of this program, the Administrator developed the WD-10 form to solicit information that is used to determine locally prevailing wages under the Davis-Bacon and Related Acts. The wage-data collection using the WD-10 form is a primary source of information and is essential to the determination of prevailing wages. The current WD-10 information collection, 1235-0015, has been approved by the Office of Management and Budget (OMB) and is currently approved for use through March 2024.

The Department is now proposing changes to the WD-10 form to improve the overall efficiency of the DBA survey process. The proposed changes aim to streamline the collection of data required for the survey and make the collection less burdensome for respondents. The revised WD-10 form, as proposed, contains questions and requests for information that are arranged in a manner that allows respondents to quickly gather and report information necessary for the Wage and Hour Division to properly determine and publish prevailing wage rates. For example, on the proposed WD-10 form, the respondent will no longer be asked to determine a peak week(s) of construction for reported projects, identify the project value, or identify contractors or subcontractors on the project. Additionally, the proposed form uses a “picklist” of labor classifications from which a respondent may choose, rather than requiring the respondent to manually enter the labor classification into an open text field. These proposed changes to the WD-10 form, among others, are designed to increase the ease of participating in a survey and solicit more usable wage data to issue more comprehensive wage determinations.

The Department also proposes to add a new WD-10A collection instrument, which will be a companion form to the WD-10 form. This collection instrument will be used pre-survey to identify potential respondents that performed construction work within the survey period in the survey area, which will enable the Department to solicit for survey participation. This pre-survey information requests will better identify additional contractors that performed construction work in the survey area. A complete listing of the proposed changes to the information collection is posted on the Department's website at: https://www.dol.gov/agencies/whd/government-contracts/construction/surveys/wd10pra.

II. Review Focus: The Department of Labor is particularly interested in comments which:

• 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;

• Enhance the quality, utility, and clarity of the information to be collected;

• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

• 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 submissions of responses.

III. Current Actions: The Department of Labor seeks approval for a revision of this information collection in order to ensure effective administration of construction contractor wage rate programs.

Type of Review: Revision.

Agency: Wage and Hour Division.

Title: Report of Construction Contractor's Wage Rates.

OMB Control Number: 1235-0015.

Affected Public: Business or other for-profit, Not-for-profit institutions, Federal, State, Local, or Tribal Government.

Agency Numbers: Forms WD-10; WD-10A.

Total Respondents: 3,641.

Total Annual Responses: 21,939.

Estimated Total Burden Hours: 7,161.

Estimated Time per Response: WD-10—20 minutes; WD-10A—10 minutes.

Frequency: On occasion.

I. Background

TMI-1 is a single unit Babcock & Wilcox Pressurized Water Reactor. CEG is the holder of Renewed Facility Operating License (RFOL) No. DPR-50 for TMI-1. On February 1, 2022, CEG notified the NRC that Exelon Generation Company, LLC (Exelon) officially changed its name to Constellation Energy Generation, LLC. By letter dated June 20, 2017, per Section 50.82(a)(1)(i) of title 10 of the Code of Federal Regulations (10 CFR), Exelon certified to the NRC that it planned to permanently cease power operations at TMI-1 on or about September 30, 2019. TMI-1 subsequently permanently ceased power operations on September 20, 2019. By letter dated September 26, 2019, pursuant to 10 CFR 50.82(a)(1)(ii), Exelon certified to the NRC that all fuel had been permanently removed from the TMI-1 reactor vessel and placed in the spent fuel pool as of September 26, 2019. Accordingly, pursuant to 10 CFR 50.82(a)(2), the TMI-1 RFOL no longer authorizes operation of the reactor or emplacement or retention of fuel in the reactor vessel.

By letter dated April 5, 2019, Exelon provided to the NRC a Post-Shutdown Decommissioning Activities Report (PSDAR) for TMI-1. The PSDAR reflected the use of a safe storage condition (SAFSTOR), thereby reflecting plans to complete decommissioning within a 60-year period after the permanent cessation of operations. The PSDAR referenced a site-specific decommissioning cost estimate (DCE) and an updated Spent Fuel Management Plan (SFMP). The staff's review of the PSDAR and SFMP concluded that Exelon demonstrated reasonable assurance that funding will be available to decommission TMI-1 pursuant to the SAFSTOR method and that the activities and associated costs of the TMI-1 SFMP appear reasonable. Exelon previously received an exemption from 10 CFR 50.82(a)(8)(i)(A) and 10 CFR 50.75(h)(1)(iv) that allows use of the TMI-1 DTF for spent fuel management at TMI-1.

By letter dated May 20, 2021, the licensee, pursuant to 10 CFR 50.12, “Specific exemptions,” submitted a request for exemption from the specific requirements of 10 CFR 50.82(a)(8)(i)(A) and 50.75(h)(1)(iv). The exemptions from 10 CFR 50.82(a)(8)(i)(A) and 10 CFR 50.75(h)(1)(iv) would permit CEG to make withdrawals from the TMI-1 DTF for site restoration activities at TMI-1. The exemption from 10 CFR 50.75(h)(1)(iv) would also permit the licensee to make these withdrawals without prior notification to the NRC, similar to withdrawals for decommissioning activities made in accordance with 10 CFR 50.82(a)(8).

The funds within the TMI-1 DTF were collected in compliance with the 10 CFR 50.75, “Reporting and recordkeeping for decommissioning planning,” financial requirements while TMI-1 was operating. The exemption request included a cash-flow analysis reflecting the balance of funds within the DTF throughout the decommissioning period, ending the year of license termination in 2081. The requirements of 10 CFR 50.82(a)(8)(i)(A) restrict the use of DTF withdrawals to expenses related to legitimate decommissioning activities consistent with the definition of decommissioning in 10 CFR 50.2, “Definitions.” The definition of “decommission” in 10 CFR 50.2 is: to remove a facility or site safely from service and reduce residual radioactivity to a level that permits—(1) Release of the property for unrestricted use and termination of the license; or (2) Release of the property under restricted conditions and termination of the license. This definition does not include activities associated with spent fuel management and site restoration activities. The requirements of 10 CFR 50.75(h)(1)(iv) also restrict the use of DTF disbursements (other than for ordinary administrative costs and other incidental expenses of the fund in connection with the operation of the fund) to decommissioning expenses until final radiological decommissioning is completed. Therefore, an exemption from 10 CFR 50.82(a)(8)(i)(A) and 10 CFR 50.75(h)(1)(iv) is needed to allow CEG to use funds from the TMI-1 DTF for site restoration activities at TMI-1.

The requirements of 10 CFR 50.75(h)(1)(iv) further provide that, except for withdrawals being made under 10 CFR 50.82(a)(8) or for payments of ordinary administrative costs and other incidental expenses of the fund in connection with the operation of the fund, no disbursement may be made from the DTF without written notice to the NRC at least 30 working days in advance. Therefore, an exemption from 10 CFR 50.75(h)(1)(iv) is also needed to allow CEG to use funds from the TMI-1 DTF for site restoration activities at TMI-1 without prior NRC notification.

The licensee has concluded that 10 CFR 50.82(a)(8)(i)(A) and 10 CFR 50.75(h)(1)(iv) would prohibit use of DTFs for activities related to site restoration prior to completion of radiological decommissioning. The licensee anticipates maintaining TMI-1 in SAFSTOR for an extended period prior to completion of radiological decommissioning. This will allow radioactive decay to occur, thereby reducing the quantity of contamination and radioactivity that must be disposed of during the decontamination and dismantlement process as well as reducing the associated occupational exposure. Exemptions from 10 CFR 50.82(a)(8)(i)(A) and 10 CFR 50.75(h)(1)(iv) are requested to allow the licensee to withdraw and use funds from the DTF for site restoration activities. The exemptions would cover all site restoration activities at TMI-1.

The requested exemption from 10 CFR 50.82(a)(8)(i)(A) and 10 CFR 50.75(h)(1)(iv) would allow CEG to use a portion of the funds from the TMI-1 DTF for site restoration activities at TMI-1 without prior notice to the NRC in the same manner that withdrawals are made under 10 CFR 50.82(a)(8) for decommissioning activities. As previously stated, 10 CFR 50.12 allows the NRC to grant exemptions from the requirements of 10 CFR part 50 when the exemptions are authorized by law. The NRC staff has determined that granting CEG's proposed exemption will not result in a violation of the Atomic Energy Act of 1954, as amended, or the Commission's regulations. Therefore, the exemption is authorized by law.

The underlying purpose of 10 CFR 50.82(a)(8)(i)(A) and 10 CFR 50.75(h)(1)(iv) is to provide reasonable assurance that adequate funds will be available for the radiological decommissioning of power reactors. Based on schedules, costs, and funding contained in the PSDAR, DCE, SFMP, and exemption request, and the NRC staff's independent review of this information, use of a portion of the TMI-1 DTF for site restoration activities at TMI-1 will not adversely impact the licensee's ability to complete radiological decommissioning within 60 years and terminate the TMI-1 license.

Furthermore, an exemption from 10 CFR 50.75(h)(1)(iv) to allow the licensee to make withdrawals from the TMI-1 DTF for site restoration activities at TMI-1 without prior written notification to the NRC will not affect the sufficiency of funds in the DTF to accomplish radiological decommissioning because such withdrawals remain constrained by the provisions of 10 CFR 50.82(a)(8)(i)(B)-(C) and are reviewable under the annual reporting requirements of 10 CFR 50.82(a)(8)(v)-(vii).

There are no new accident precursors created by using the TMI-1 DTF in the proposed manner. Thus, the probability of postulated accidents is not increased. Also, the consequences of postulated accidents are not increased. No changes are being made in the types or amounts of effluents that may be released offsite. There is no significant increase in occupational or public radiation exposure. The requested exemption would not diminish the effectiveness of other regulations that ensure the available funding for decommissioning, including 10 CFR 50.82(a)(6), which prohibits licensees from performing any decommissioning activities that could foreclose unrestricted release of the site, result in significant environmental impacts not previously reviewed, or result in there no longer being reasonable assurance that adequate funds will be available for decommissioning. Therefore, the requested exemption will not present an undue risk to the public health and safety.

The requested exemption would allow the licensee to use funds from the TMI-1 DTF for site restoration activities at TMI-1. This change to enable the use of a portion of the funds from the DTF for site restoration activities has no relation to security issues. Therefore, the common defense and security is not impacted by the requested exemption.

Special circumstances, in accordance with 10 CFR 50.12(a)(2)(ii), are present whenever application of the regulation in the particular circumstances is not necessary to achieve the underlying purpose of the regulation.

The underlying purpose of 10 CFR 50.82(a)(8)(i)(A) and 10 CFR 50.75(h)(1)(iv), which restrict withdrawals from DTFs to expenses for radiological decommissioning activities, is to provide reasonable assurance that adequate funds will be available for radiological decommissioning of power reactors and license termination. Strict application of these requirements would prohibit the withdrawal of funds from the TMI-1 DTF for activities other than radiological decommissioning activities at TMI-1, such as for site restoration activities, until final radiological decommissioning at TMI-1 has been completed.

However, the NRC staff's review of the exemption request, including consideration of the information in the PSDAR, DCE, SFMP, and the annual DTF certification reports and the staff's independent analysis, found that reasonable assurance exists that adequate funds will be available in the TMI-1 DTF to complete decommissioning and terminate the TMI-1 license, with excess funding available to pay for site restoration activities within the scope of the exemption request.

The staff's cash-flow analysis projects that the TMI-1 DTF will contain approximately $253.7 million at the end of license termination activities in 2081 (using a 2 percent real rate of return as allowed by 10 CFR 50.75(e)(1)(ii)), considering its use for payment of spent fuel management throughout the 60-year decommissioning period (as approved by a previous exemption) and its use for the site restoration activities within the scope of the current exemption request. This analysis aligns with the cash-flow analysis provided by the licensee in its exemption request.

As presented in Table 2 of the exemption request, the beginning DTF balance was the December 31, 2020, DTF value ($742,497k) less the 2020 site radiological decommissioning costs ($14,663k) and the 2018, 2019, and 2020 spent fuel management costs ($54,673k) that were not yet reimbursed as of December 31, 2020. The staff's cash-flow analysis estimates that the licensee projected costs for radiological decommissioning to be approximately $977.5 million, costs for spent fuel management to be approximately $160.1 million, and cost for site restoration activities to be approximately $92.8 million, all in 2020 dollars. This amounts to total estimated costs of approximately $1.23 billion for radiological decommissioning, spent fuel management, and site restoration activities with license termination occurring in 2081. In its analysis, the NRC staff assumed a 2 percent annual real rate of return on the DTF balance, less annual costs, resulting in a positive DTF balance of approximately $253.7 million at the time of license termination.

Therefore, the NRC staff finds that the licensee has provided reasonable assurance that adequate funds will be available for the radiological decommissioning of TMI-1, even with the disbursement of funds from the DTF for spent fuel management (previously approved) and site restoration activities (currently requested). Accordingly, the NRC staff concludes that application of the requirements of 10 CFR 50.82(a)(8)(i)(A) and 10 CFR 50.75(h)(1)(iv), that funds from the DTF only be used for radiological decommissioning activities and not for site restoration activities, is not necessary to achieve the underlying purpose of the rule. Thus, special circumstances are present supporting approval of the exemption request.

In its submittal, the licensee also requested exemption from the requirement of 10 CFR 50.75(h)(1)(iv) concerning prior written notification to the NRC of withdrawals from DTFs for activities other than radiological decommissioning. The underlying purpose of notifying the NRC prior to such withdrawals of funds from DTFs is to provide an opportunity for NRC intervention, when deemed necessary, if the withdrawals are for expenses other than those authorized by 10 CFR 50.75(h)(1)(iv) and 10 CFR 50.82(a)(8) that could result in there being insufficient funds in the DTFs to accomplish radiological decommissioning.

By granting the exemption to 10 CFR 50.75(h)(1)(iv) and 10 CFR 50.82(a)(8)(i)(A), the NRC staff considers that withdrawals consistent with the licensee's exemption request are authorized. As stated previously, the NRC staff determined that there are sufficient funds in the TMI-1 DTF to complete radiological decommissioning activities, as well as to conduct spent fuel management (previously approved) and site restoration activities (currently requested), consistent with the TMI-1 PSDAR, DCE, SFMP and May 20, 2021, exemption request. Pursuant to the requirements in 10 CFR 50.82(a)(8)(v) and (vii), licensees are required to monitor and annually report to the NRC the status of the DTF and the licensee's funding for spent fuel management. These reports provide the NRC staff with awareness of, and the ability to take action on, any actual or potential funding deficiencies. Additionally, 10 CFR 50.82(a)(8)(vi) requires that the annual financial assurance status report must include additional financial assurance to cover the estimated cost of completion if the sum of the balance of any remaining decommissioning funds, plus earnings on such funds calculated at not greater than a 2-percent real rate of return, together with the amount provided by other financial assurance methods being relied upon, does not cover the estimated cost to complete the decommissioning. The requested exemption would not allow the withdrawal of funds from the DTF for any other purpose that is not currently authorized in the regulations without prior notification to the NRC. Therefore, the granting of the exemption to 10 CFR 50.75(h)(1)(iv) to allow the licensee to make withdrawals from the TMI-1 DTF to cover authorized expenses for site restoration activities at TMI-1 without prior written notification to the NRC will still meet the underlying purpose of the regulation.

Special circumstances, in accordance with 10 CFR 50.12(a)(2)(iii), are present whenever compliance would result in undue hardship or other costs that are significantly in excess of those contemplated when the regulation was adopted, or that are significantly in excess of those incurred by others similarly situated. The licensee states that the DTF contains funds in excess of the estimated costs of radiological decommissioning and that these excess funds are needed for site restoration activities. Preventing access to those excess funds in DTFs because site restoration activities are not associated with radiological decommissioning would create an unnecessary financial burden without any corresponding safety benefit. The adequacy of the TMI-1 DTF to cover the cost of activities associated with site restoration activities, in addition to radiological decommissioning and spent fuel management (pursuant to a previously approved exemption), is supported by the NRC staff's review as described herein and reflected in Attachment 1 of the exemption request. If the licensee cannot use the TMI-1 DTF for site restoration activities, it would need to obtain additional funding that would not be recoverable from the DTF, or it would have to modify its decommissioning approach and methods. The NRC staff concludes that either outcome would impose an unnecessary and undue burden significantly in excess of that contemplated when 10 CFR 50.82(a)(8)(i)(A) and 10 CFR 50.75(h)(1)(iv) were adopted.

The underlying purposes of 10 CFR 50.82(a)(8)(i)(A) and 10 CFR 50.75(h)(1)(iv) would be achieved by allowing the licensee to use a portion of the TMI-1 DTF for site restoration activities at TMI-1 without prior NRC notification, and compliance with the regulations would result in an undue hardship or other costs that are significantly in excess of those contemplated when the regulations were adopted. Thus, the special circumstances in 10 CFR 50.12(a)(2)(ii) and 10 CFR 50.12(a)(2)(iii) exist and support the approval of the requested exemptions.

In accordance with 10 CFR 51.31(a), the Commission has determined that the granting of the exemptions will not have a significant effect on the quality of the human environment (see Environmental Assessment and Finding of No Significant Impact published in the Federal Register on June 6, 2022 (87 FR 34311)).

In consideration of the above, the NRC staff finds that reasonable assurance exists that adequate funds will be available in the TMI-1 DTF to complete radiological decommissioning of the site and to terminate the TMI-1 license, with excess funding available to pay for spent fuel management (previously approved) and site restoration activities within the scope of the exemption request. There is no decrease in safety associated with the DTF being used to fund activities associated with site restoration.

Accordingly, the Commission has determined that, pursuant to 10 CFR 10 CFR 50.12(a), the exemptions are authorized by law, will not present an undue risk to the public health and safety, and are consistent with the common defense and security. Also, special circumstances are present. Therefore, the Commission hereby grants CEG the exemptions from the requirements of 10 CFR 50.82(a)(8)(i)(A) and 10 CFR 50.75(h)(1)(iv) to allow CEG to use of a portion of the funds from the TMI-1 DTF for site restoration activities, without prior NRC notification.

The exemptions are effective upon issuance.

The documents identified in the following table are available to interested persons through ADAMS.

The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on June 7, 2022, it filed with the Postal Regulatory Commission a USPS Request to Add Priority Mail Contract 744 to Competitive Product List. Documents are available at www.prc.gov, Docket Nos. MC2022-64, CP2022-70.

The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on June 8, 2022, it filed with the Postal Regulatory Commission a USPS Request to Add Priority Mail Contract 745 to Competitive Product List. Documents are available at www.prc.gov, Docket Nos. MC2022-65, CP2022-71.