Title: Request and Consent Forms for Privacy Records.

OMB Number: 0503-New.

Expiration Date of Approval: Three years from approval date.

Type of Request: New information collection.

Abstract: OMB M-21-04 provides guidance for Federal agencies to modernize the processes by which individuals may request access to, and consent to the disclosure of, records protected under the Privacy Act of 1974. As required by the Creating Advanced Streamlined Electronic Services for Constituents Act of 2019 (“CASES Act”), this guidance outlines the responsibilities of agencies for accepting access and consent forms provided in a digital format from individuals who are properly identity-proofed and authenticated. The request and consent forms, hosted at www.usda.gov/privacy-policy/privacy-office, will allow individuals to electronically request privacy records from the USDA. Information collected in this form will allow the USDA to locate any privacy records and submit to the identity-proofed requestor.

Estimate of Burden: Public reporting burden for this collection of information is estimated to average 0.8 hours per response.

Type of Respondents: Individuals.

Estimated Number of Respondents: 300.

Estimated Number of Responses: 600.

Estimated Number of Responses per Respondent: 2.

Estimated Total Annual Burden on Respondents: 100 hours.

Comments are invited on: (1) 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) 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) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Comments may be sent to U.S. Department of Agriculture, Office of the Chief Information Security Officer, Information Security Center, Chief Privacy Office. All comments received will be available for public inspection during regular business hours at the same address.

All responses to this notice will be summarized and included in the request for OMB approval. All comments will become a matter of public record.

The Office of Management and Budget's (OMB) regulation (5 CFR part 1320) implementing provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13) requires that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities (see 5 CFR 1320.8(d)). This notice identifies an information collection that RUS will submit to OMB for regular approval.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Rural Business-Cooperative Service, including whether the information will have practical utility; (b) the accuracy of the Rural Business-Cooperative Service's estimate of the burden of the proposed collection of information including validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of 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.

Comments may be sent by the Federal eRulemaking Portal: Go to https://www.regulations.gov and, in the “Search” box, type in the Docket No. RUS-22-TELECOM-0054. A link to the Notice will appear. You may submit a comment here by selecting the “Comment” button or you can access the “Docket” tab, select the “Notice,” and go to the “Browse & Comment on Documents” Tab. Here you may view comments that have been submitted as well as submit a comment. To submit a comment, select the “Comment” button, complete the required information, and select the “Submit Comment” button at the bottom. Information on using Regulations.gov , including instructions for accessing documents, submitting comments, and viewing the docket after the close of the comment period, is available through the site's “FAQ” link at the bottom.

A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a currently valid OMB Control Number. Data furnished by the applicants will be used to determine eligibility for program benefits. Furnishing the data is voluntary; however, failure to provide data could result in program benefits being withheld or denied.

Title: Broadband Technical Assistance Program.

OMB Control Number: 0572-NEW.

Type of Request: New information collection.

Abstract: The Rural Utilities Service administers the Broadband Technical Assistance Program (BTA Program) as authorized pursuant to the Infrastructure Investment and Jobs Act (Pub. L. 117-58). The purpose of the program is to provide financial assistance to technical assistance providers and rural communities to promote the expansion of broadband service into unserved rural areas. Program funds must be used to support broadband technical assistance activities which include, but are not limited to, project planning and community engagement, operations support, financial sustainability, environmental compliance, construction and engineering, accessing federal resources, and data collection and reporting.

The reporting burden covered by this collection of information consists of forms, documents and written burden to support a request for funding for BTA Program assistance. This information collection will be used to obtain information necessary to evaluate applications to determine the eligibility of the applicant and the project for the program and to qualitatively assess the project's technical and financial merit to determine which projects should be funded.

Estimate of Burden: Public reporting burden for this collection of information is estimated to average 1.109 hours per response.

Respondents: Respondents for this data my include Tribes and Tribal Entities, state or local governments, a territory or possession of the United States, an institution of higher learning, non-profit entities with 501(c)(3) IRS status, cooperatives or mutual organizations, corporations and limited liability companies or limited liability partnerships.

Estimated Number of Respondents: 25.

Estimated Number of Responses per Respondent: 18.04.

Estimated Number of Responses: 451.

Estimated Total Annual Burden on Respondents: 500 hours.

Copies of this information collection can be obtained from Pamela Bennett, Rural Development Innovation Center, Regulations Management Division, at (202) 720-9639. All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

This meeting is available to the public through the Zoom link above. If joining only via phone, callers can expect to incur charges for calls they initiate over wireless lines and the Commission will not refund any incurred charges.

Individuals who are deaf, deafblind and hard of hearing may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the conference call number and conference ID number.

Members of the public are also entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be emailed to Victoria Moreno at vmoreno@usccr.gov. All written comments received will be available to the public.

Persons who desire additional information may contact the Regional Programs Unit at (202) 809-9618. Records and documents discussed during the meeting will be available for public viewing as they become available at www.facadatabase.gov . Persons interested in the work of this Committee are advised to go to the Commission's website, http://www.usccr.gov, or may contact the Regional Programs Unit at the above email or e-mail address.

FESAC members are appointed by the Secretary of Commerce. The Committee advises the Under Secretary for Economic Affairs, BEA and Census Bureau Directors, and the Commissioner of the Department of Labor's BLS on statistical methodology and other technical matters related to the collection, tabulation, and analysis of federal economic statistics. The Committee is established in accordance with the Federal Advisory Committee Act (5 U.S.C. app. 2).

The Committee aims to have a balanced representation among its members, considering such factors as geography, age, sex, race, ethnicity, technical expertise, community involvement, and knowledge of programs and/or activities related to FESAC. Individual members are selected based on their expertise in or representation of specific areas as needed by FESAC.

This meeting is open to the public. The meeting is accessible to people with disabilities. Requests for foreign language interpretation or other auxiliary aids should be directed to Gianna Marrone at gianna.marrone@bea.gov by December 2, 2022. Persons with extensive questions or statements must submit them in writing by December 2, 2022, to Gianna Marrone, gianna.marrone@bea.gov.

Authority: Federal Advisory Committee Act (FACA), as amended, 5 U.S.C., App.

The Federal Economic Statistics Advisory Committee was established in accordance with the Federal Advisory Committee Act (Title 5, United States Code, Appendix 2). The following provides information about the Committee, membership, and the nomination process.

The Committee advises the Directors of the Bureau of Economic Analysis (BEA) and the U.S. Census Bureau, as well as the Commissioner of the U.S. Department of Labor's Bureau of Labor Statistics (BLS), on statistical methodology and other technical matters related to the design, collection, tabulation, and analysis of federal economic statistics.

The Committee functions solely as an advisory committee to the senior officials of BEA, the Census Bureau, and BLS (the agencies). Important aspects of the committee's responsibilities include, but are not limited to:

a. Recommending research to address important technical problems arising in federal economic statistics.

b. Identifying areas in which better coordination of the agencies' activities would be beneficial;

c. Exploring ways to enhance the agencies' economic indicators to make them timelier, more accurate, and more specific to meeting changing demands and future data needs;

d. Improving the means, methods, and techniques to obtain economic information needed to produce current and future economic indicators; and

e. Coordinating, in its identification of agenda items, with other existing academic advisory committees chartered to provide agency-specific advice, for the purpose of avoiding duplication of effort.

The Committee meets once or twice a year, budget permitting. Additional meetings may be held as deemed necessary by the Under Secretary for Economic Affairs or the Designated Federal Official. All Committee meetings are open to the public in accordance with the Federal Advisory Committee Act.

The Committee will comprise approximately 16 members who serve at the pleasure of the Secretary of Commerce. Members shall be appointed by the Under Secretary for Economic Affairs in consultation with the agencies. Committee members shall be professionals in appropriate disciplines, including economists, statisticians, survey methodologists, computer scientists, data scientists, and behavioral scientists who are experts in their fields, recognized for their scientific, professional, and operational achievements and objectivity. Membership will represent data users with expertise from the public sector, academia, and the private sector. Members will be chosen to achieve a balanced membership that will meet the needs of the agencies.

Members shall serve as Special Government Employees (SGEs) and shall be subject to ethics rules applicable to SGEs.

A FESAC member term is three years.

Members may serve more than one term as described in the FESAC Charter, available at: https://apps.bea.gov/fesac/.

Members of the Committee serve without compensation but may receive reimbursement for Committee-related travel and lodging expenses.

The Committee is currently filling one or more positions on the FESAC.

The Under Secretary of Economic Affairs, in consultation with the agencies, will consider nominations of all qualified individuals to ensure that the Committee includes the areas of experience noted above. Individuals may nominate themselves or other individuals, and professional associations and organizations may nominate one or more qualified persons for membership on the Committee. Nominations shall state that the nominee is willing to serve as a member and carry out the duties of the Committee. A nomination package should include the following information for each nominee:

1. A letter of nomination stating the name, affiliation, and contact information for the nominee, the basis for the nomination ( i.e., what specific attributes recommend the nominee for service in this capacity), and the nominee's field(s) of experience;

2. a biographical sketch of the nominee;

3. a copy of the nominee's curriculum vitae; and

4. the name, return address, email address, and daytime telephone number at which the nominator can be contacted.

The Committee aims to have a balanced representation among its members, considering such factors as geography, age, sex, race, ethnicity, technical expertise, community involvement, and knowledge of programs and/or activities related to FESAC. Individuals will be selected based on their expertise in or representation of specific areas as needed by FESAC.

All nomination information should be provided in a single, complete package. Interested applicants should send their nomination package to Gianna Marrone, Committee Management Official, at Gianna.Marrone@bea.gov (subject line “FESAC Nomination”).

Authority: Federal Advisory Committee Act (FACA), as amended, 5 U.S.C., App.

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

Section 302(g)(2) of the Magnuson-Stevens Act states that each Council shall establish such advisory panels as are necessary or appropriate to assist it in carrying out its functions under the Act. For the purposes of this section, NMFS applies the above provision to Atlantic HMS management (see section 304(g)(1) of the Magnuson-Stevens Act, which provides that the Secretary will prepare FMPs for HMS and consult with advisory panels under section 302(g) for such FMPs). As such, NMFS has established the SEDAR Pool under this section. The SEDAR Pool currently consists of 32 individuals, each of whom may be selected to review data and advise NMFS regarding the scientific information including, but not limited to, data and models used in stock assessments for oceanic sharks in the Atlantic Ocean, Gulf of Mexico, and Caribbean Sea. While the SEDAR Pool was created specifically for Atlantic oceanic sharks, it may be expanded to include other HMS, as needed.

The primary responsibility of individuals in the SEDAR Pool is to review, at SEDAR workshops, the scientific information including, but not limited to, data and models used in stock assessments that are used to advise NMFS about the conservation and management of Atlantic HMS specifically, but not limited to, Atlantic sharks. Individuals in the SEDAR Pool, if selected for a particular workshop, may participate in the various data, assessment, and review workshops during the SEDAR process of any HMS stock assessment. In order to ensure that the review is unbiased, individuals who participated in a data and/or assessment workshop for a particular stock assessment will not be allowed to serve as SEDAR Pool reviewers for the same stock assessment. However, these individuals may be asked to attend the review workshop to answer specific questions from the reviewers concerning the data and/or assessment workshops. Members of the SEDAR Pool may serve as members of other advisory panels concurrent with, or following, their service on the SEDAR Pool.

The SEDAR Pool is comprised of individuals representing the commercial and recreational fishing communities for Atlantic sharks, the environmental community active in the conservation and management of Atlantic sharks, and the academic community that have relevant expertise either with sharks and/or stock assessment methodologies for marine fish species. In addition, individuals who may not necessarily work directly with sharks, but who are involved in fisheries with similar life history, biology, and fishery issues may be part of the SEDAR Pool. Members of the SEDAR Pool must have demonstrated experience in the fisheries, related industries, research, teaching, writing, conservation, or management of marine organisms. The distribution of representation among the interested parties is not defined or limited.

Additional members of the SEDAR Pool may also include representatives from each of the 5 Atlantic Regional Fishery Management Councils, each of the 18 Atlantic states, both the U.S. Virgin Islands and Puerto Rico, and each of the relevant interstate commissions: the Atlantic States Marine Fisheries Commission and the Gulf States Marine Fisheries Commission.

If NMFS requires additional members to ensure a diverse pool of individuals for data or assessment workshops, NMFS may request individuals to become members of the SEDAR Pool outside of the annual nomination period.

SEDAR Pool members serve at the discretion of the Secretary. Not all members will attend each SEDAR workshop. Rather, NMFS will invite certain members to participate at specific stock assessment workshops dependent on their ability to participate, discuss, and offer scientific input and advice regarding the species being assessed.

NMFS is not obligated to fulfill any requests ( e.g., requests for an assessment of a certain species) that may be made by the SEDAR Pool or its individual members. Members of the SEDAR Pool who are invited to attend stock assessment workshops will not be compensated for their services, but may be reimbursed for their travel-related expenses to attend such workshops.

Member tenure will be for 5 years. Nominations are sought for terms beginning early in 2023 and expiring in 2028. Nomination packages should include:

1. The name, address, phone number, and email of the applicant or nominee;

2. A description of the applicant's or nominee's interest in Atlantic shark stock assessments or the Atlantic shark fishery;

3. A statement of the applicant's or nominee's background and/or qualifications; and

4. A written commitment that the applicant or nominee shall participate actively and in good faith in the tasks of the SEDAR Pool, as requested.

Individual members of the SEDAR Pool meet to participate in stock assessments at the discretion of the Office of Sustainable Fisheries, NMFS. Stock assessment timing, frequency, and relevant species will vary depending on the needs determined by NMFS and SEDAR staff. NMFS began in 2022 and will continue into 2024, a research track assessment to be followed by an operational assessment for the hammerhead shark species in the hammerhead shark management group. Following the hammerhead operational assessment, NMFS anticipates beginning a research track assessment for bull, spinner, tiger, and finetooth sharks. During an assessment year, meetings and meeting logistics will be determined according to the SEDAR Guidelines. All meetings are open for observation by the public.

The meeting notice published on (87 FR 60125). This notice announces that the meeting is cancelled and will be rescheduled and published in the Federal Register at a later date.

Authority: 16 U.S.C. 1801 et seq.

Under the PRA, 44 U.S.C. 3501 et seq., Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of Information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3 and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA, 44 U.S.C. 3506(c)(2)(A), requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed information collection including each proposed extension of an existing information collection, before submitting the collection to OMB for approval. To comply with this requirement, the CFTC is publishing notice of a proposed extension of the currently approved information collection listed below. An agency may not conduct or sponsor, and a person is not required to respond to, an information collection unless it displays a currently valid OMB control number.

Title: Swap Data Recordkeeping and Reporting Requirements (OMB Control No. 3038-0096). This is a request for extension of a currently approved information collection.

Abstract: The collection of information is needed to ensure that the CFTC and other regulators have access to swap data as required by the Commodity Exchange Act, as amended by the Dodd-Frank Wall Street Reform and Consumer Protection Act (“Dodd-Frank Act”). The Dodd-Frank Act directed the CFTC to adopt rules providing for the reporting of data relating to swaps. In 2012, the CFTC adopted Regulation 45, which imposes recordkeeping and reporting requirements relating to pre-enactment and historical swaps.

With respect to the collection of information, the CFTC invites comments on:

• Whether the proposed collection of information is necessary for the proper performance of the functions of the CFTC, including whether the information will have a practical use;

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

• Ways to enhance the quality, usefulness, and clarity of the information to be collected; and

• Ways to minimize the burden of 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.

You should submit only information that you wish to make available publicly. If you wish the CFTC to consider information that you believe is exempt from disclosure under the Freedom of Information Act (“FOIA”), a petition for confidential treatment of the exempt information may be submitted according to the procedures established in § 145.9 of the CFTC's regulations. 1

The CFTC reserves the right, but shall have no obligation, to review, pre-screen, filter, redact, refuse or remove any or all of your submission from https://www.cftc.gov that it may deem to be inappropriate for publication, such as obscene language. All submissions that have been redacted or removed that contain comments on the merits of the Information Collection Request will be retained in the public comment file and will be considered as required under the Administrative Procedure Act and other applicable laws, and may be accessible under FOIA.

Burden Statement: Provisions of CFTC Regulations 45.2, 45.3, 45.4, 45.5, 45.6, 45.10, and 45.14 result in information collection requirements within the meaning of the PRA. With respect to the ongoing reporting and recordkeeping burdens associated with swaps, the CFTC believes that SDs, MSPs, SEFs, DCMs, DCOs, SDRs, and non-SD/MSP counterparties incur an annual time-burden of 1,276,705 hours. This time-burden represents a proportion of the burden respondents incur to operate and maintain their swap data recordkeeping and reporting systems.

Respondents/Affected Entities: Swap Dealers, Major Swap Participants, SEFs, DCMs, DCOs, and other counterparties to a swap transaction ( i.e., end-user, non-SD/non-MSP counterparties).

Estimated number of respondents: 1,732.

Estimated average burden hours per respondent: 737 hours. 2

Estimated total annual burden hours on respondents: 1,276,705 hours.

Frequency of collection: Ongoing.

There are no capital costs or operating and maintenance costs associated with this collection.

Title: Rule 50.50 End-User Notification of Non-Cleared Swap (OMB Control No. 3038-0085). This is a request for an extension of a currently approved information collection.

Abstract: CFTC Rule 50.50 specifies the requirements for eligible end-users who may elect the end-user exception from the Commission's swap clearing requirement, as provided under section 2(h)(7) of the Commodity Exchange Act (“CEA”). Rule 50.50 requires the counterparties to report certain information to a swap data repository registered with the Commission, or to the Commission directly, if one or more counterparties elects the end-user exception. The rule establishes a reporting requirement for end-users that is critical to ensuring compliance with the Commission's clearing requirement under section 2(h)(1) of the CEA and is necessary in order for Commission staff to prevent abuse of the end-user exception. In addition, this collection relates to information that the Commission needs to monitor elections of the end-user exception and to assess market risks.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. 2 On August 18, 2022, the Commission published in the Federal Register notice of the proposed extension of this information collection and provided 60 days for public comment on the proposed extension, 87 FR 50849 (“60-Day Notice”). The Commission did not receive any comments on the 60-Day Notice.

Burden Statement: The Commission is revising its estimate of the burden for this collection to reflect the current number of respondents and estimated burden hours. The respondent burden for this collection is estimated to be as follows:

Estimated Number of Respondents: 1,200.

Estimated Average Burden Hours per Respondent: 0.58 hours.

Estimated Total Annual Burden Hours: 696 hours.

Frequency of Collection: On occasion; annually.

There are no capital costs or operating and maintenance costs associated with this collection.

Title: Swap Documentation (OMB Control No. 3038-0088). 1 This is a request to revise a currently approved information collection.

Abstract: On September 11, 2012, the Commission adopted Commission Regulations 23.500 through 23.505  2 (the “Regulations”) under Sections 4s(f), (g) and (i)  3 of the Commodity Exchange Act (“CEA”). The Regulations require, among other things, that swap dealers (“SDs”)  4 and major swap participants (“MSPs”)  5 develop and retain written swap trading relationship documentation. They also establish requirements for SDs and MSPs regarding swap confirmation, portfolio reconciliation, and portfolio compression. Under the Regulations, SDs and MSPs are obligated to maintain records of the policies and procedures required by the rules. 6

Confirmation, portfolio reconciliation, and portfolio compression are important post-trade processing mechanisms for reducing risk and improving operational efficiency. The information collection obligations imposed by the Regulations are necessary to ensure that each SD and MSP maintains the required records of their business activities and an audit trail sufficient to conduct comprehensive and accurate trade reconstruction. The information collections contained in the Regulations are also essential to ensuring that SDs and MSPs document their swaps, reconcile their swap portfolios to resolve discrepancies and disputes, and wholly or partially terminate some or all of their outstanding swaps through regular portfolio compression exercises. These collections of information are mandatory.

In this particular instance, while the information collection has been extended until June 30, 2025, the Commission is revising its aggregate burden by removing the burden hour estimate on cleared swap recordkeeping, as this subcategory was proposed in 2012 but not finalized by the Commission and its burden estimate had been included erroneously under this information collection in previous renewals. 7 Additionally, the total number of respondents (combined SDs and MSPs) is now increased to 108. The overall burden hours for each remaining category within the information collection have increased proportionally, to reflect the increase in the number of respondents.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. 8 On August 19, 2022, the Commission published in the Federal Register notice of the proposed extension of this information collection and provided 60 days for public comment on the proposed renewal, 87 FR 51065 (“60-Day Notice”). The Commission did not receive any comments on the 60-Day Notice.

Burden Statement: Based on the proposed revisions to the estimated aggregate burden as discussed above, the respondent burden for this collection is estimated to be as follows:

Estimated Number of Respondents: 108.

Estimated Average Burden Hours per Respondent: 7,324.5.

Estimated Total Annual Burden Hours: 791,046.

Frequency of Collection: As applicable.

There are no capital costs or operating and maintenance costs associated with this collection.

Title: Clearing Exemption for Certain Swaps Entered into by Cooperatives (OMB Control No. 3038-0102). This is a request for an extension of a currently approved information collection.

Abstract: Section 2(h)(1)(A) of the Commodity Exchange Act (“CEA”) requires certain entities to submit swaps for clearing if they are required to be cleared by the Commission. Commission regulation 50.51 permits certain cooperatives to elect not to clear certain swaps that otherwise would be required to be cleared, provided that they meet certain conditions. The rule establishes a reporting requirement for cooperatives that is critical to ensuring compliance with the Commission's clearing requirement under section 2(h)(1) of the CEA and is necessary in order for Commission staff to prevent abuse of the cooperative exemption. In addition, this collection relates to information that the Commission needs to monitor elections of the cooperative exemption and to assess market risks.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. 2 On August 18, 2022, the Commission published in the Federal Register notice of the proposed extension of this information collection and provided 60 days for public comment on the proposed extension, 87 FR 50850 (“60-Day Notice”). The Commission did not receive any comments on the 60-Day Notice.

Burden Statement: The Commission anticipates that there will continue to be approximately 25 eligible respondents and the hourly burden will remain the same. the burden for this collection to reflect the current number of respondents and estimated burden hours. The respondent burden for this collection is estimated to be as follows:

Estimated Number of Respondents: 25.

Estimated Average Burden Hours per Respondent: 1 hour.

Estimated Total Annual Burden Hours: 25 hours.

Frequency of Collection: On occasion; annually.

There are no capital costs or operating and maintenance costs associated with this collection.

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

Title of Collection: Generic Clearance for Federal Student Aid Customer Satisfaction Surveys and Focus Groups Master Plan.

OMB Control Number: 1845-0045.

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

Respondents/Affected Public: An extension without change of a currently approved collection.

Total Estimated Number of Annual Responses: 8,050,000.

Total Estimated Number of Annual Burden Hours: 400,000.

Abstract: The Higher Education Amendments of 1998 established Federal Student Aid (FSA) as the first Performance-Based Organization (PBO). One purpose of the PBO is to improve service to student and other participants in the student financial assistance programs authorized under title IV of the Higher Education Act of 1965, as amended, including making those programs more understandable to students and their parents. To do that, FSA has committed to ensuring that all people receive service that matches or exceeds the best service available in the private sector. The legislation's requires establish an on-going need for FSA to be engaged in an interactive process of collecting information and using it to improve program services and processes. The use of customer surveys and focus groups allows FSA to gather that information from the affected parties in a timely manner so as to improve communications with our product users.

On September 10, 2021, the Department published a notice in the Federal Register (86 FR 50707) announcing Third-Party Access to the Department's Information Technology Systems and Notice of Criminal Penalties for Misuse of Access Devices (2021 Notice). The 2021 Notice provided a list of what it termed “Rules of Behavior” that included in paragraph (m) the revocation of access if a user has a Title IV loan that goes into default. This notice clarifies the language in paragraph (m). All other information in the 2021 Notice remains the same.

In FR Doc 2021-19536 appearing on page 50707-50709 in the Federal Register of September 10, 2021 (86 FR 50707), the following corrections are made:

1. On page 50709, in the first column, the paragraph (m) under the heading “Code of Conduct” is revised to read as follows:

If you have Title IV loans, they must be in good standing. If you have a loan that goes into default, your access to the Department's information systems to administer the Title IV Programs under the HEA will be revoked. This means your access to conduct business functions within the Department's IT systems will be revoked. This includes, but not limited to, access to: Common Origination and Disbursement (COD), Financial Aid Administrator (FAA) Access to Central Processing System (CPS) Online, and the National Student Loan Data System (NSLDS®) will be revoked. Access to manage and view your own Title IV loans and financial aid history through the Department's information systems and/or your federal loan servicer as an aid recipient or borrower will not be revoked.

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

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

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

Program Authority: 20 U.S.C 1001; 20 U.S.C. 1018; 20 U.S.C. 1092b; and 20 U.S.C. 1097.

On September 28, 2022, DOE published a NOA and requested comment on its Clean Hydrogen Production Standard (CHPS) Draft Guidance. (87 FR 58776). The NOA contained the initial proposal for the CHPS and established a target for the lifecycle ( i.e., well-to-gate) emissions intensity of hydrogen production, based on the Infrastructure Investment and Jobs Act (IIJA) definition of the term “clean hydrogen” and other factors set forth in section 40315(b) of the IIJA.

DOE has received several requests to extend the public comment period for 60 and 90 days to help investigate the request and respond appropriately with considered comments given the importance of the standard and the amount of detailed information requested.

DOE has determined that reopening the public comment period for 25 days is appropriate to enable submission of robust information that can inform DOE's programs. Thus, DOE is reopening the comment period through November 14, 2022.

Signing Authority: This document of the Department of Energy was signed on October 17, 2022, by Dr. Geraldine Richmond, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purpose only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Office has been authorized to sign and submit the document in the electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

This information collection request contains:

(1) OMB No. 1905-0169;

(2) Information Collection Request Title: Manufacturing Energy Consumption Survey;

(3) Type of Request: Three-year extension with changes;

(4) Purpose: Form EIA-846 is a self-administered sample survey designed to collect energy consumption and expenditures data from establishments in the manufacturing sector; i.e., North American Industry Classification System (NAICS) codes 31-33. The previous MECS required respondents to complete multiple collection forms depending on an establishment's primary business activity classification under NAICS. The increased use of technology by means of an internet data collection system has allowed the MECS to eliminate the need to have multiple forms.

(4a) Proposed Changes to Information Collection: EIA proposes adding a “Yes/No” follow up question to the Electricity: Total Purchased section of Form EIA-846. The electricity purchased questions on Form EIA-846 request information about the quantity and expenditure of an establishment's purchased energy, in this case, electricity. The follow up question EIA proposes to Form EIA-846 would identify those geographical areas where multiple establishments may be purchasing and using electricity made from renewable sources, such as solar, wind, geothermal, and hydropower. The purpose of this question is to better understand the technology, equipment, and infrastructure that may be shared among manufacturing establishments. This change is consistent with the Bipartisan Infrastructure Law (Infrastructure Investment and Jobs Act);

(5) Annual Estimated Number of Respondents: 15,000;

(6) Annual Estimated Number of Total Responses: 3,750;

(7) Annual Estimated Number of Burden Hours: 34,565;

(8) Annual Estimated Reporting and Recordkeeping Cost Burden: The cost of the burden hours is estimated to be $2,882,030 (34,565 burden hours times $83.38 per hour). EIA estimates that there are no additional costs to respondents associated with the surveys other than the costs associated with the burden hours.

Statutory Authority: 15 U.S.C. 772(b), 42 U.S.C. 7101 et seq.

The LGAC has been deliberating on the following issues and will discuss and vote on draft recommendations for each at this meeting.

1. As EPA works to support the water workforce, how can we ensure that we are making effective and efficient investments. The EPA asks the LGAC to advise on the following ways to support:

2. The Inflation Reduction Act (IRA) allocates significant funding for greenhouse gas reduction programs, which will help states, tribes, territories, and local governments take action against climate change through grant programs, technical assistance, code development, and more. At the same time, it allocates $1 billion to cover the incremental costs of replacing dirty medium and heavy-duty vehicles zero-emitting vehicles. What information and resources do local governments need to pursue such initiatives, specifically those that reduce greenhouse gas emissions through the decarbonization of municipal fleets and buildings? As EPA implements this new program, how can it ensure that local communities and their concerns are supported?

Additionally, the LGAC will hear recommendations developed by its Small Communities Advisory Subcommittee (SCAS) on the following topic:

How can EPA better support small communities as it implements the Bipartisan Infrastructure Law. Specifically, how can EPA:

All interested persons are invited to attend and participate. The LGAC will hear comments from the public from 3:40-3:50 p.m. (EST). Individuals or organizations wishing to address the Committee or Subcommittee will be allowed a maximum of five (5) minutes to present their point of view. Also, written comments should be submitted electronically to LGAC@epa.gov for the LGAC and SCAS. Please contact the DFO at the email listed under FOR FURTHER INFORMATION CONTACT to schedule a time on the agenda by October 12, 2021. Time will be allotted on a first-come first-served basis, and the total period for comments may be extended if the number of requests for appearances requires it.

Registration: The meeting will be held virtually through an online audio and video platform. Members of the public who wish to participate should register by contacting the Designated Federal Officer (DFO) at LGAC@epa.gov by November 17, 2022. The agenda and other supportive meeting materials will be available online at https://www.epa.gov/ocir/local-government-advisory-committee-lgac and will be emailed to all registered. In the event of cancellation for unforeseen circumstances, please contact the DFO or check the website above for reschedule information.

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

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

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

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

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

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

• US EPA Region 1. Alyssa Sierra (HBS), 5 Post Office Square, Suite 100, Mail Code: 01-5, Boston MA 02109-3912, (617) 918-1603.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The complete list of Federal facilities that now make up the Docket and the NPL and NFRAP status are available to interested parties and can be obtained at http://www.epa.gov/fedfac/fedfacts or by contacting the EPA HQ Docket Coordinator at the address provided in the FOR FURTHER INFORMATION CONTACT section of this notice. As of the date of this notice, the total number of Federal facilities that appear on the Docket is 2,391.

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

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

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

• Code 4. No Hazardous Waste Generated.

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

• Code 6. Redundant Listing/Site on Facility.

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

• Code 8. Does Not Fit Facility Definition.

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

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

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

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

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

• Code 19. Sites Were Combined Into One Facility.

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

• Code 20. Reporting Provisions Change.

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

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

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

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

The Fedwire Funds Service is a real-time gross settlement system owned and operated by the Reserve Banks that enables participants to make immediately final payments using either their balances held at the Reserve Banks or intraday credit provided by the Reserve Banks. The Fedwire Funds Service and the CHIPS® funds-transfer system, which is owned and operated by The Clearing House Payments Company L.L.C. (TCH), are the main large-value payment systems in the United States. 1

On April 26, 2019, the Office of Management and Budget published OMB memorandum 19-16, Centralized Mission Support Capabilities for the Federal Government (available at https://www.whitehouse.gov/wp-content/uploads/2019/04/M-19-16.pdf ). Mission support business standards, established and agreed to by agencies, using the Federal Integrated Business Framework (FIBF) website at https://ussm.gsa.gov/fibf/, enable the Federal Government to better coordinate on the decision-making needed to determine what can be adopted and commonly shared. These business standards are an essential first step towards agreement on outcomes, data, and cross-functional end-to-end processes that will drive economies of scale and leverage the Government's buying power. The business standards will be used as the foundation for common mission support services shared by Federal agencies.

GSA serves as the TRT business standards lead on the Business Standards Council (BSC). The goal of the travel and expense management business standards is to drive travel consistency, equity, and standardization across the Federal Government.

GSA is seeking public feedback on these draft business standards ( i.e., functions and activities, business capabilities, business use cases, standard data elements, service measures, and business information exchange standards between the travel solution and financial management solution(s)), including comments on understandability of the standards, suggested changes, and usefulness of the draft standards to industry and agencies.

Guiding questions in standard development include:

• Do the draft business standards appropriately document the business processes covered?

• Are the draft business standards easy to understand?

• Will your organization be able to show how your solutions and/or services can meet these draft business standards?

• What would you change about the draft business standards? Is there anything missing?

Comments will be used in formulation of the final business standards.

Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee's objectives. Nominees will be selected based on expertise in the fields of breast health, breast cancer, disease prevention and risk reduction, survivorship (including metastatic breast cancer), hereditary breast and ovarian cancer, or in related disciplines with a specific focus on young women. Persons with personal experience with early onset breast cancer are also eligible to apply. This includes, but may not be limited to breast cancer survivors <45 years of age and caregivers of said persons. Federal employees will not be considered for membership. Members may be invited to serve up to four-year terms.

Selection of members is based on candidates' qualifications to contribute to the accomplishment of ACBCYW objectives http://www.cdc.gov/maso/facm/facmacbcyw.html.

The U.S. Department of Health and Human Services policy stipulates that committee membership be balanced in terms of points of view represented, and the committee's function. Appointments shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, gender identity, HIV status, disability, and cultural, religious, or socioeconomic status. Nominees must be U.S. citizens, and cannot be full-time employees of the U.S. Government. Current participation on federal workgroups or prior experience serving on a federal advisory committee does not disqualify a candidate; however, HHS policy is to avoid excessive individual service on advisory committees and multiple committee memberships. Committee members are Special Government Employees, requiring the filing of financial disclosure reports at the beginning and annually during their terms. CDC reviews potential candidates for ACBCYW membership each year, and provides a slate of nominees for consideration to the Secretary of HHS for final selection. HHS notifies selected candidates of their appointment near the start of the term in November 2023, or as soon as the HHS selection process is completed. Note that the need for different expertise varies from year to year and a candidate who is not selected in one year may be reconsidered in a subsequent year. Nominees must be U.S. citizens, and cannot be full-time employees of the U.S. Government. Candidates should submit the following items:

Current curriculum vitae, including complete contact information (telephone numbers, mailing address, email address).

At least one letter of recommendation from person(s) not employed by the U.S. Department of Health and Human Services. (Candidates may submit letter(s) from current HHS employees if they wish, but at least one letter must be submitted by a person not employed by an HHS agency ( e.g., CDC, NIH, FDA, etc.).

A short biography (150 words or less).

Nominations may be submitted by the candidate him- or herself, or by the person/organization recommending the candidate.

The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.

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

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

1. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Medicaid Program Face-to-Face Requirements for Home Health Services and Supporting Regulations; Use: Physicians (or for medical equipment, authorized non-physician practitioners (NPPs) including nurse practitioners, clinical nurse specialists and physician assistants) must document that there was a face-to-face encounter with the Medicaid beneficiary prior to the physician making a certification that home health services are required. The burden associated with this requirement is the time and effort to complete this documentation. The burden also includes writing, typing, or dictating the face-to-face documentation and signing/dating the documentation. Form Number: CMS-10609 (OMB control number: 0938-1319); Frequency: Occasionally; Affected Public: Private sector (business or other for-profits); Number of Respondents: 381,148; Total Annual Responses: 1,143,443; Total Annual Hours: 190,955. For policy questions regarding this collection contact Alexandra Smilow at 410-786-0790.

Description: Grantees of the TANF program are required by statute to report financial data on a quarterly basis. Form ACF-196T is used by tribal agencies administering the TANF program to report these quarterly expenditure data and to request quarterly grant funds. Failure to collect the data would seriously compromise the Office of Family Assistance and ACF's ability to monitor TANF expenditures and compliance with statutory requirements. These data are also needed to estimate outlays and to prepare reports and budget submissions for Congress.

Respondents: Tribal agencies receiving a direct grant from OFA to administer a TANF program.

Estimated Total Annual Burden Hours: 306.

Comments: The Department specifically requests comments on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication.

Authority: Social Security Act, Section 409; 45 CFR 286,245-286.285.

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

This information collection helps to implement provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), added by the Right to Try Act, which requires sponsors and manufacturers who provide an “eligible investigational drug” under the Right to Try Act to submit to FDA an annual summary of such use. Regulations under § 300.200 (21 CFR 300.200) will require that sponsors and manufacturers submit to FDA an annual summary no later than March 31 of each year, including data for the preceding calendar year, that includes the following data elements:

• The name of the eligible investigational drug and applicable investigational new drug application number.

• The number of doses supplied to the eligible patient.

• The number of eligible patients treated.

• The use for which the eligible investigational drug was made available to the eligible patient.

• Any known serious adverse events and outcomes that the eligible patient treated with an eligible investigational drug experienced.

Description of Respondents: Respondents to the information collection are sponsors and manufacturers who provide an eligible investigational drug to eligible patients in accordance with the Right to Try Act and will submit to FDA annual summaries.

In the Federal Register of September 14, 2022 (87 FR 56269), we published a final rule (RIN 0910-AI36), including an analysis of the information collection, and discussed the development of an associated form to facilitate submission of the requisite information. Accordingly, we have developed Form FDA 5023 entitled “Right To Try Reporting Requirement: Annual Summary,” which is currently available in the docket for comment purposes only, and we are inviting public comment. As required by the applicable statute, section 561B of the FD&C Act (21 U.S.C. 360bbb-0a), the information is submitted to an FDA-designated point of contact, and in accordance with instructions to be posted at: https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try.

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

Consistent with estimates in our Final Regulatory Impact Analysis for the associated final rule, we estimate that six sponsors and manufacturers will prepare and submit Form FDA 5023 and assume it takes 2.5 hours to prepare and submit each summary, which results in a total of 15 hours annually.

On November 22, 1974, FDA approved ANDA 083483 for Alcohol and Dextrose Injection. In a letter dated June 23, 1999, Bayer Corporation, which had at least partially acquired Miles Laboratories Inc., notified FDA that Alcohol and Dextrose Injection, 5 mL/100 mL, 5g/100 mL, the subject of ANDA 083483, was no longer marketed, and FDA moved the drug product to the “Discontinued Drug Product List” section of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” FDA has not received information specified in 21 CFR 314.72 to change the ownership of ANDA 083483, although Miles Laboratories Inc. does not appear to be separately manufacturing drug products. The Agency is therefore identifying Miles Laboratories Inc. as the ANDA holder of record in this Federal Register notice, but in the event that another entity holds ANDA 083483, the Agency is also providing notice to that entity.

The holder of an approved ANDA to market a new drug for human use is required to submit annual reports to FDA concerning its approved ANDA under §§ 314.81 and 314.98 (21 CFR 314.81 and 314.98). Because the holder of ANDA 083483 for Alcohol and Dextrose Injection, 5 mL/100 mL, 5g/100 mL, has repeatedly failed to submit the required annual reports, FDA proposes to withdraw approval of ANDA 083483 under § 314.150(b)(1) (21 CFR 314.150(b)(1)).

Additionally, under 21 CFR 314.161, FDA has determined that Alcohol and Dextrose Injection, 5 mL/100 mL, 5g/100 mL, approved under ANDA 083483 was withdrawn from sale for safety and effectiveness reasons (see 86 FR 72606 (December 22, 2021)) (this determination also applied to other applications and to the 10 mL/100 mL, 5 g/100 mL strength of Alcohol and Dextrose Injection approved under NDA 004589). In light of our determination, FDA proposes to withdraw approval of ANDA 083483 under § 314.150(a)(2)(i) because the Agency has scientific data and experience to show that Alcohol and Dextrose Injection, 5 mL/100 mL, 5 g/100 mL, is unsafe for use under the conditions of use for which the product was approved.

As explained in our Federal Register notice determining that Alcohol and Dextrose was withdrawn for safety and effectiveness reasons, Alcohol and Dextrose Injection is indicated to provide increased caloric intake. The use of Alcohol and Dextrose raises several safety concerns because there are many risks associated with the exposure to alcohol. Today, alcohol is contraindicated for use in patients with neurologic disorders, such as seizures, who have current or past substance abuse problems or who are pregnant. It can cause intoxication, respiratory depression, and disturbances in serum glucose levels. FDA-approved alternatives for intravenous calorie supplementation that do not include alcohol were approved after these Alcohol and Dextrose products and are available today.

Therefore, notice is given to the ANDA holder and to all other interested persons that the Director of CDER proposes to issue an order, under section 505(e)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)(2)), withdrawing approval of ANDA 083483 and all amendments and supplements thereto on the grounds that: (1) the ANDA holder has failed to submit reports required under §§ 314.81 and 314.98 and section 505(k) of the FD&C Act, and (2) the Agency has scientific data and experience to show that Alcohol and Dextrose Injection, 5 mL/100 mL, 5 g/100 mL, is unsafe for use under the conditions of use for which the product was approved.

In accordance with section 505(e) of the FD&C Act and §§ 314.150(a)(2)(i) and (b)(1) and § 314.200 (21 CFR 314.200), the ANDA holder is hereby provided an opportunity for a hearing to show why the approval of ANDA 083483 should not be withdrawn and an opportunity to raise, for administrative determination, all issues relating to the legal status of the drug product covered by ANDA 083483.

An ANDA holder who decides to seek a hearing must file the following: (1) a written notice of participation and request for a hearing (see DATES and ADDRESSES ) and (2) the data, information, and analyses relied on to demonstrate that there is a genuine and substantial issue of fact that requires a hearing (see DATES and ADDRESSES ). Any other interested person may also submit comments on this notice. The procedures and requirements governing this notice of opportunity for a hearing, notice of participation and request for a hearing, the information and analyses to justify a hearing, other comments, and a grant or denial of a hearing are contained in § 314.200 and in 21 CFR part 12.

The failure of an ANDA holder to file a timely written notice of participation and request for a hearing, as required by § 314.200, constitutes an election by that ANDA holder not to avail itself of the opportunity for a hearing concerning CDER's proposal to withdraw approval of the ANDA and constitutes a waiver of any contentions concerning the legal status of the drug product. FDA will then withdraw approval of the ANDA, and the drug product may not thereafter be lawfully introduced or delivered for introduction into interstate commerce. Any new drug product introduced or delivered for introduction into interstate commerce without an approved ANDA is subject to regulatory action at any time.

A request for a hearing may not rest upon mere allegations or denials but must present specific facts showing that there is a genuine and substantial issue of fact that requires a hearing (§ 314.200(g)). If a request for a hearing is not complete or is not supported, the Commissioner of Food and Drugs will enter summary judgment against the person who requests the hearing, making findings and conclusions, and denying a hearing (§  314.200(g)(1)).

All submissions under this notice of opportunity for a hearing must be filed in two copies. Except for data and information prohibited from public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 1905, the submissions may be seen at the Dockets Management Staff (see ADDRESSES ) between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.

This notice is issued under section 505(e) of the FD&C Act and under authority delegated to the Director of CDER by the Commissioner of Food and Drugs.

FDA is announcing the availability of a draft guidance for industry entitled “Topical Dermatologic Corticosteroids: In Vivo Bioequivalence.” This draft guidance is intended to assist applicants who submit ANDAs for topical corticosteroids. This draft guidance describes recommendations for an in vivo pharmacodynamic approach to demonstrate the bioequivalence of topical corticosteroids. When finalized, this guidance will replace FDA's 1995 guidance for industry of the same name.

This draft guidance provides recommendations for the study design, method qualification, data analysis, and data reporting for the pilot dose-duration vasoconstrictor response study and pivotal vasoconstrictor bioequivalence study used for topical corticosteroids. The draft guidance also discusses considerations and approaches for estimating key study parameters and sample size for the pivotal vasoconstrictor bioequivalence study.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Topical Dermatologic Corticosteroids: In Vivo Bioequivalence.” 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. 3501-3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR 314 have been approved under OMB control number 0910-0001. The collections of information related to current good manufacturing practices have been approved under OMB control number 0910-0139. The collections of information pertaining to controlled correspondence related to generic drug development have been approved under OMB control number 0910-0797.

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

FDA is announcing the availability of a draft guidance for industry entitled “Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs.” This draft guidance is intended to assist applicants who submit ANDAs for liquid-based and/or other semisolid products applied to the skin, including integumentary and mucosal ( e.g., vaginal) membranes. This draft guidance document provides recommendations for physicochemical and structural (collectively, “Q3”) characterizations that can be used: (1) to identify the dosage form of a proposed generic (test) topical product and (2) to describe properties of the drug product that may be critical to its performance (to support a demonstration of BE). This draft guidance does not address Q3 characterization of topical products for purposes of product quality control.

Basic Q3 characterization of a topical product can be used to describe its dosage form ( e.g., an emulsion). The nomenclature used to describe the dosage form of topical products ( e.g., solutions, suspensions, gels, lotions, creams, shampoos, ointments, pastes, etc.) is not precisely defined by a systematic classification of the compositional, physicochemical, or structural attributes of the drug product. Consequently, for topical products, it may not be possible to infer the Q3 attributes of a particular dosage form based upon the dosage form nomenclature.

Comprehensive Q3 characterization of a topical product can be used to establish a detailed profile of Q3 attributes that specifically describes the nature of that product and identifies a collection of attributes that describe the arrangement of matter ( e.g., the polymorphic form(s) of the active ingredient(s) and/or the pH of the drug product) that may modulate the systemic or local availability of the active ingredient(s) from the product. Because Q3 characterization describes essential attributes of a drug product that may be critical to its performance, differences in Q3 attributes between a test product and the reference standard selected by FDA can indicate a risk that the differences may impact the respective bioavailability and/or BE of the two products. Conversely, a demonstration that there are no differences in Q3 attributes between a test and reference standard substantially mitigates the risk of potential failure modes for BE that may otherwise arise from any differences in Q3 attributes.

This draft guidance provides recommendations on the types of characterizations that constitute a basic and comprehensive Q3 characterization. This draft guidance also describes the concepts of “sameness,” “similarity,” and “difference” in comparing Q3 characterizations of two topical products, and how a showing of “Q3 sameness,” “Q3 similarity,” or “Q3 difference” between a test topical product and the reference standard may impact what additional evidence may be recommended to demonstrate BE, as part of a comparative product characterization-based approach.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs.” 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 draft 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. 3501-3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information for the submission of ANDAs have been approved under OMB control number 0910-0001. Applicant submission of controlled correspondence related to generic drug development and FDA approval is approved under OMB control number 0910-0797. The collections of information that support Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies have been approved under OMB control number 0910-0119. The collections of information in 21 CFR part 320 for “Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans” have been approved under OMB control number 0910-0014. The recordkeeping requirement for Current Good Manufacturing Practice (CGMP) sample retention in 21 CFR 211.170 has been approved under OMB control number 0910-0139.

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

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

The Mammography Quality Standards Act (Pub. L. 102-539) requires the establishment of a Federal certification and inspection program for mammography facilities; standards for accreditation and certification bodies for mammography facilities; and standards for mammography equipment, personnel, and practices, including quality assurance. Implementing regulations are found in part 900 (21 CFR part 900). The regulations are intended to assure safe, reliable, and accurate mammography on a nationwide level. Under the regulations, as a first step in becoming certified, mammography facilities must become accredited by an FDA-approved accreditation body (AB). This requires undergoing a review of their clinical images and providing the AB with information showing that they meet the equipment, personnel, quality assurance, and quality control standards, and have a medical reporting and recordkeeping program, a medical outcomes audit program, and a consumer complaint mechanism. On the basis of this accreditation, facilities are then certified by FDA or an FDA-approved State certification agency and must prominently display their certificate. These actions are taken to ensure safe, accurate, and reliable mammography on a nationwide basis.

FDA meets with its National Mammography Quality Assurance Advisory Committee (NMQAAC) for the purposes of advising FDA's mammography program on advances in mammography technology and procedures and on appropriate quality standards for mammography facilities. NMQAAC is made up of representatives of the mammography community, consumer and industry groups, and government. The meetings are open to the public and time is allotted for public statements on issues of concern in the mammography field. The chairperson may also call upon attendees to contribute to the committee discussions.

FDA also regularly meets or holds teleconferences with its approved accreditation bodies and State certification agencies to discuss issues of mutual concern. We also engage with the Conference of State Radiation Program Directors (CRCPD), a professional organization of State agencies concerned with radiation protection. The CRCPD has established a standing Mammography Committee, which meets with FDA mammography staff at least once a year.

Finally, in recent years, FDA mammography staff have met several times with representatives of manufacturers working on the new applications of digital technology in mammography to resolve problems preventing the making of that technology generally available. FDA mammography staff have also worked with representatives of the manufacturers to develop quality assurance manuals for full field digital mammography units.

In the Federal Register of August 8, 2022 (87 FR 48678), we published a notice soliciting public comment of the proposed information collection. No comments were received.

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

FDA is announcing the availability of a document entitled “Human Gene Therapy for Neurodegenerative Diseases; Guidance for Industry.” Neurodegenerative diseases are a heterogeneous group of disorders characterized by progressive degeneration of the structure and function of the central nervous system or peripheral nervous system. These diseases vary in etiology, prevalence, diagnosis, and management, and include genetic as well as age-related diseases. The guidance document provides recommendations to sponsors developing a GT product for neurodegenerative diseases affecting adult and pediatric patients. The guidance focuses on considerations for product development, preclinical testing, and clinical trial design.

In the Federal Register of January 6, 2021 (86 FR 549), FDA announced the availability of the draft guidance of the same title dated January 2021. FDA received several comments on the draft guidance and those comments were considered as the guidance was finalized. Changes to the guidance include clarifications to the recommendations regarding use of tumorigenic cell lines, comparability studies, and crossover designs for clinical trials. In addition, editorial changes were made to improve clarity. The guidance announced in this notice finalizes the draft guidance dated January 2021.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Human Gene Therapy for Neurodegenerative Diseases.” 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. 3501-3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 50 have been approved under OMB control number 0910-0130; the collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014; the collections of information in 21 CFR part 601 have been approved under OMB control number 0910-0338; and the collections of information in the guidance entitled “Expedited Programs for Serious Conditions—Drugs and Biologics” have been approved under OMB control number 0910-0765.

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

In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry entitled “Bioequivalence Recommendations for Specific Products” that explained the process that would be used to make product-specific guidances available to the public on FDA's website at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

As described in that guidance, FDA adopted this process as a means to develop and disseminate product-specific guidances and provide a meaningful opportunity for the public to consider and comment on those guidances. Under that process, draft guidances are posted on FDA's website and announced periodically in the Federal Register . The public is encouraged to submit comments on those recommendations within 60 days of their announcement in the Federal Register . FDA considers any comments received and either publishes final guidances or publishes revised draft guidances for comment. Guidances were last announced in the Federal Register on August 3, 2022 (87 FR 47425).

This notice announces new and revised draft product-specific guidances that are being posted on FDA's website concurrently with FDA's draft guidances for industry entitled “Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs,” “In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs,” and “In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs.” FDA recommends that applicants consult the relevant product-specific guidance, in conjunction with the guidances referenced above, when considering the design and conduct of studies supporting an evaluation of BE for locally acting, liquid-based and/or other semisolid products applied to the skin, as well as integumentary and mucosal ( e.g., vaginal) membranes.

FDA is announcing the availability of new draft product-specific guidances for industry for drug products containing the following active ingredients:

FDA is announcing the availability of revised draft product-specific guidances for industry for drug products containing the following active ingredients:

For a complete history of previously published Federal Register notices related to product-specific guidances, go to https://www.regulations.gov and enter Docket No. FDA-2007-D-0369.

These draft guidances are being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). These draft guidances, when finalized, will represent the current thinking of FDA on, among other things, the product-specific design of BE studies to support ANDAs. They do not establish any rights for any person and are not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

FDA tentatively concludes that these draft guidances contain no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

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

FDA is announcing the availability of a draft document entitled “In Vitro Permeation Test Studies for Topical Products Submitted in ANDAs.” This draft guidance document provides recommendations on IVPT studies for locally acting liquid-based and/or other semisolid topical products. This draft guidance is intended to assist applicants who are submitting ANDAs for such products by providing recommendations for IVPT studies, which can support a demonstration that two topical products are bioequivalent.

Once validated, an IVPT study may be used to assess the rate and extent to which an active ingredient from a topical product becomes available at or near a site of action in the skin and may be used to characterize and compare the rate and extent of bioavailability for a drug from a test topical product and the reference standard. This draft guidance focuses on general considerations and recommendations for the method development, method validation, and conduct of IVPT studies that are submitted in ANDAs and intended to support a demonstration of bioequivalence.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “In Vitro Permeation Test Studies for Topical Products Submitted in ANDAs.” 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. 3501-3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information for the submission of ANDAs have been approved under OMB control number 0910-0001. Applicant submission of controlled correspondence related to generic drug development and FDA approval is approved under OMB control number 0910-0797. The collections of information that support Good Laboratory Practice for Non-Clinical Laboratory Studies have been approved under OMB control number 0910-0119. The collections of information in part 320 for “Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans” have been approved under OMB control number 0910-0014. The recordkeeping requirement for CGMP sample retention in 21 CFR 211.170 has been approved under OMB control number 0910-0139.

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

FDA is announcing the availability of a draft guidance for industry entitled “In Vitro Release Test Studies for Topical Products Submitted in ANDAs.” This draft guidance provides recommendations on IVRT studies for locally acting liquid-based and/or other semisolid topical products. This draft guidance is intended to assist applicants who are submitting ANDAs for such products, by providing recommendations for IVRT studies, which can be used to support a demonstration that two topical products are bioequivalent.

Once validated, an IVRT study may also be useful in controlling product quality and/or establishing acceptability of post-approval manufacturing changes. This draft guidance focuses on general considerations and recommendations for the method development, method validation, and conduct of IVRT studies that are submitted in ANDAs and intended to support a demonstration of bioequivalence.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “In Vitro Release Test Studies for Topical Products Submitted in ANDAs.” 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. 3501-3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information for the submission of ANDAs have been approved under OMB control number 0910-0001. Applicant submission of controlled correspondence related to generic drug development and FDA approval is approved under OMB control number 0910-0797. The collections of information that support “Good Laboratory Practice (GLP) for Non-Clinical Laboratory Studies” have been approved under OMB control number 0910-0119. The collections of information in 21 CFR part 320 for “Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans” have been approved under OMB control number 0910-0014. The recordkeeping requirement for CGMP sample retention in 21 CFR 211.170 has been approved under OMB control number 0910-0139.

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

Since 1980, Healthy People has provided a comprehensive set of national health promotion and disease prevention objectives with 10-year targets aimed at improving the health of all. Healthy People 2030 objectives present a picture of the nation's health at the beginning of the decade, establish national goals and targets to be achieved by the year 2030, and monitor progress over time. The U.S. Department of Health and Human Services (HHS) is soliciting the submission of written comments regarding one core objective proposed to be added to Healthy People 2030. The public is also invited to submit proposals for additional new core, developmental, or research objectives that meet the criteria outlined below.

Healthy People 2030 is the product of an extensive collaborative process that relies on input from a diverse array of individuals and organizations, both within and outside the federal government, with a common interest in improving the nation's health. Public comments are a cornerstone of Healthy People 2030. During the development of Healthy People 2030, HHS asked for the public's comments to help shape the initiative's framework (vision, mission, and overarching goals) and its objectives. HHS plans to periodically seek public comment to ensure Healthy People 2030 remains relevant and reflects emerging public health issues.

The public now is invited to comment on one new core objective proposed to be added to Healthy People 2030. This new objective was developed by federal subject matter experts, approved by the Healthy People Federal Interagency Workgroup and is presented for the public's review and comment. The objective is:

1. Social Determinants of Health-NEW-07: Increase the proportion of the voting age citizens who vote. Data Source: Current Population Survey (CPS), U.S. Census Bureau and the U.S. Bureau of Labor Statistics (BLS).

The public is also invited to propose additional core, developmental, or research objectives for consideration that address critical public health issues. Proposed new objectives must meet all the objective selection criteria (see below).

Core objectives must meet the following 5 criteria to be included in Healthy People 2030. Core objectives should (1) have a reliable, nationally representative data source with baseline data no older than 2015; (2) have at least 2 additional data points beyond the baseline during the decade; (3) be of national importance; (4) have effective, evidence-based interventions available to achieve the objective; and (5) have data to help address disparities and achieve health equity.

Developmental objectives will have the following characteristics: (1) represent high priority issues; (2) do not have reliable baseline data yet; and (3) have evidence-based interventions available.

Research objectives will have the following characteristics: (1) represent key opportunities to make progress in areas with limited prior research, a high health or economic burden, or significant disparities between population groups; (2) may or may not have reliable baseline data; and (3) do not have evidence-based interventions available.

Written comments and evidence-based information should be submitted by email to HP2030Comment@hhs.gov by 11:59 p.m. ET on December 2, 2022. Comments received in response to this notice will be reviewed and considered by the Healthy People topic area workgroups, Federal Interagency Workgroup on Healthy People 2030, and other federal subject matter experts.

TSA is providing notice of this meeting in accordance with section 1969 of the TSA Modernization Act, Division K of the FAA Reauthorization Act of 2018, Public Law 115-254 (132 Stat. 3186; Oct. 5, 2018), codified at 6 U.S.C. 204. The STSAC advises, consults with, reports to, and makes recommendations to the TSA Administrator on surface transportation security matters, including the development, refinement, and implementation of policies, programs, initiatives, rulemakings, and security directives pertaining to surface transportation security. The STSAC also considers risk-based security approaches in the performance of its duties. While the STSAC is exempt from the Federal Advisory Committee Act (5 U.S.C. App.), see 6 U.S.C. 205(f), paragraph 204(c)(6)(B) requires that TSA hold at least one public meeting each year.

The meeting will be open to the public via WebEx. Members of the public, all non-STSAC members, and non-TSA staff who wish to participate, must register via email by submitting their name, contact number, and affiliation to STSAC@tsa.dhs.gov by November 14, 2022. Attendance may be limited due to WebEx meeting constraints. Attendees will be admitted on a first-to-register basis. Attendance information will be provided upon registration.

Members of the public wishing to present oral or written statements must make advance arrangements by November 14, 2022. The statements must specifically address issues pertaining to the items listed in Meeting Agenda discussed above; requests must be submitted via email to STSAC@tsa.dhs.gov. Speakers are required to limit their comments to three minutes.

The STSAC and TSA are committed to providing equal access to this meeting for all participants. If you need alternative formats or services because of a disability, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section by November 14, 2022.

The information collection notice was previously published in the Federal Register on July 08, 2022, at 87 FR 40856, allowing for a 60-day public comment period. USCIS did receive three 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-2012-0003. 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: Extension, Without Change, of a Currently Approved Collection.

(2) Title of the Form/Collection: Application for Provisional Unlawful Presence Waiver.

(3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection: I-601A; USCIS.

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

Primary: Individuals or households. Section 212(a)(9)(B)(i)(I) and (II) of the Immigration and Nationality Act (INA or the Act) provides for the inadmissibility of certain individuals who have accrued unlawful presence in the United States. There is also a waiver provision incorporated into section 212(a)(9)(B)(v) of the Act, which allows the Secretary of Homeland Security to exercise discretion to waive the unlawful presence grounds of inadmissibility on a case-by-case basis. The information collected from an applicant on an Application for Provisional Unlawful Presence Waiver of Inadmissibility, Form I-601A, is necessary for U.S. Citizenship and Immigration Services (USCIS) to determine not only whether the applicant meets the requirements to participate in the streamlined waiver process provided by regulation, but also whether the applicant is eligible to receive the provisional unlawful presence waiver.

(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-601A is 63,000 and the estimated hour burden per response is 1.5 hours. The estimated total number of respondents for the collection of biometrics is 63,000 and the estimated hour burden per response is 1.17 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 168,210 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 $3,212,390.

The information collection notice was previously published in the Federal Register on July 13, 2022, at 87 FR 41735, allowing for a 60-day public comment period. USCIS did receive one comment 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-2011-0001 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: Extension, Without Change, of a Currently Approved Collection.

(2) Title of the Form/Collection: Free Training for Civics and Citizenship of Adults; Civics and Citizenship Toolkit.

(3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection: G-1190, G-1515; USCIS.

(4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Individuals or households. This information is necessary to register for civics and citizenship of adults training and to obtain a civics and citizenship toolkit.

(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 Form G-1190 is 2,500 and the estimated hour burden per response is 0.083 hours. The estimated total number of respondents for the information collection Form G-1515 is 1,200 and the estimated hour burden per response is responses is 0.166 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 407 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 $0. The registration occurs electronically which eliminates any cost for postage, and no other costs are incurred by the respondent.

Background. —On August 5, 2022, the Commission determined that the domestic interested party group response to its notice of institution (87 FR 25671, May 2, 2022) of the subject five-year review was adequate and that the respondent interested party group response was inadequate. The Commission did not find any other circumstances that would warrant conducting a full review. 1 Accordingly, the Commission determined that it would conduct an expedited review pursuant to section 751(c)(3) of the Tariff Act of 1930 (19 U.S.C. 1675(c)(3)).

For further information concerning the conduct of this review and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A and B (19 CFR part 201), and part 207, subparts A, D, E, and F (19 CFR part 207).

Staff report. —A staff report containing information concerning the subject matter of the review has been placed in the nonpublic record, and will be made available to persons on the Administrative Protective Order service list for this review on November 14, 2022. A public version will be issued thereafter, pursuant to § 207.62(d)(4) of the Commission's rules.

Written submissions. —As provided in § 207.62(d) of the Commission's rules, interested parties that are parties to the review and that have provided individually adequate responses to the notice of institution, 2 and any party other than an interested party to the review may file written comments with the Secretary on what determination the Commission should reach in the review. Comments are due on or before November 21, 2022 and may not contain new factual information. Any person that is neither a party to the five-year review nor an interested party may submit a brief written statement (which shall not contain any new factual information) pertinent to this review by November 21, 2022. However, should the Department of Commerce (“Commerce”) extend the time limit for its completion of the final results of its review, the deadline for comments (which may not contain new factual information) on Commerce's final results is three business days after the issuance of Commerce's results. If comments contain business proprietary information (BPI), they must conform with the requirements of §§ 201.6, 207.3, and 207.7 of the Commission's rules. The Commission's Handbook on Filing Procedures, available on the Commission's website at https://www.usitc.gov/documents/handbook_on_filing_procedures.pdf, elaborates upon the Commission's procedures with respect to filings.

In accordance with §§ 201.16(c) and 207.3 of the rules, each document filed by a party to the review must be served on all other parties to the review (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service.

Determination. —The Commission has determined this review is extraordinarily complicated and therefore has determined to exercise its authority to extend the review period by up to 90 days pursuant to 19 U.S.C. 1675(c)(5)(B).

Authority: This review is being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to § 207.62 of the Commission's rules.

Authority: The authority for institution of this investigation is contained in section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, and in section 210.10 of the Commission's Rules of Practice and Procedure, 19 CFR 210.10 (2022).

Scope of Investigation: Having considered the complaint, the U.S. International Trade Commission, on October 18, 2022, ordered that —

(1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain products identified in paragraph (2) by reason of infringement of one or more of claims 1, 2, 5-11, 14, 15, 17, 18, 20, 21, 23, 25, 26, 28, 29, 31, and 33 of the '273 patent and claims 1, 2, 5-11, 14, 15, 17, 18, 20, 22, and 23 of the '685 patent; claims 1-6, 8-10, and 11-19 of the '118 patent, and whether an industry in the United States exists or is in the process of being established as required by subsection (a)(2) of section 337;

(2) Pursuant to section 210.10(b)(1) of the Commission's Rules of Practice and Procedure, 19 CFR 210.10(b)(1), the plain language description of the accused products or category of accused products, which defines the scope of the investigation, is “(1) certain smart thermostat devices that serve as in-unit hubs for the remote control of smart door locks, (2) systems including those smart thermostat devices, and (3) internal circuity, printed circuit boards, and communication components for those smart thermostat devices.”;

(3) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:

(a) The complainants are:

(b) The respondents are the following entities alleged to be in violation of section 337, and are the parties upon which the complaint is to be served:

(4) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge. The Office of Unfair Import Investigations will not be participating as a party in this investigation.

Responses to the complaint and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(e) and 210.13(a), as amended in 85 FR 15798 (March 19, 2020), such responses will be considered by the Commission if received not later than 20 days after the date of service by the complainants of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown.

Failure of a respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the issuance of an exclusion order or a cease and desist order or both directed against the respondent.

In accordance with 21 CFR 1301.34(a), this is notice that on September 20, 2022, Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown, Pennsylvania 18106-9032, applied to be registered as an importer of the following basic class(es) of controlled substance(s):

The company plans to import the listed controlled substances for clinical trials only. No other activities for these drug codes are authorized for this registration.

Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or non- approved finished dosage forms for commercial sale.

The Controlled Substances Act (CSA) prohibits the cultivation and distribution of marihuana except by persons who are registered under the CSA to do so for lawful purposes. In accordance with the purposes specified in 21 CFR 1301.33(a), DEA is providing notice that the entity identified below has applied for registration as a bulk manufacturer of schedule I controlled substances. In response, registered bulk manufacturers of the affected basic class(es), and applicants therefor, may submit electronic comments on or objections of the requested registration, as provided in this notice. This notice does not constitute any evaluation or determination of the merits of the application submitted.

The applicant plans to manufacture bulk active pharmaceutical ingredients (APIs) for product development and distribution to DEA registered researchers. If the application for registration is granted, the registrant would not be authorized to conduct other activity under this registration aside from those coincident activities specifically authorized by DEA regulations. DEA will evaluate the application for registration as a bulk manufacturer for compliance with all applicable laws, treaties, and regulations and to ensure adequate safeguards against diversion are in place.

As this applicant has applied to become registered as a bulk manufacturer of marihuana, the application will be evaluated under the criteria of 21 U.S.C. 823(a). DEA will conduct this evaluation in the manner described in the rule published at 85 FR 82333 on December 18, 2020, and reflected in DEA regulations at 21 CFR part 1318.

In accordance with 21 CFR 1301.33(a), DEA is providing notice that on February 18, 2022, Morrison Newfound Valley Manufacturing, 262 Morrison Road, Bristol, New Hampshire 03222, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substances:

The Controlled Substances Act (CSA) prohibits the cultivation and distribution of marihuana except by persons who are registered under the CSA to do so for lawful purposes. In accordance with the purposes specified in 21 CFR 1301.33(a), DEA is providing notice that the entity identified below has applied for registration as a bulk manufacturer of schedule I controlled substances. In response, registered bulk manufacturers of the affected basic class(es), and applicants therefor, may submit electronic comments on or objections of the requested registration, as provided in this notice. This notice does not constitute any evaluation or determination of the merits of the application submitted.

The applicant plans to manufacture bulk active pharmaceutical ingredients (API) for product development and distribution to DEA registered researchers. If the application for registration is granted, the registrant would not be authorized to conduct other activity under this registration aside from those coincident activities specifically authorized by DEA regulations. DEA will evaluate the application for registration as a bulk manufacturer for compliance with all applicable laws, treaties, and regulations and to ensure adequate safeguards against diversion are in place.

As this applicant has applied to become registered as a bulk manufacturer of marihuana, the application will be evaluated under the criteria of 21 U.S.C. 823(a). DEA will conduct this evaluation in the manner described in the rule published at 85 FR 82333 on December 18, 2020, and reflected in DEA regulations at 21 CFR part 1318.

In accordance with 21 CFR 1301.33(a), DEA is providing notice that on September 1, 2022, Rocky Mountain Biotech, LLC, 4740 Dillon Drive, Pueblo, Colorado 81008-2112, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substances: