Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 9521-9522 [2023-03073]

Download as PDF Federal Register / Vol. 88, No. 30 / Tuesday, February 14, 2023 / Notices Board of Governors of the Federal Reserve System. Michele Taylor Fennell, Deputy Associate Secretary of the Board. [FR Doc. 2023–03124 Filed 2–13–23; 8:45 am] BILLING CODE P GENERAL SERVICES ADMINISTRATION [OMB Control No. 3090–XXXX; Docket No. 2023–0001; Sequence No. 1] Information Collection; Overseas Employment Agreement; GSA Form 5040 A. Purpose Office of Human Resource Management, Division of Human Capital Policy and Programs, General Services Administration (GSA). ACTION: Notice of request for comments regarding a request for a new OMB clearance. AGENCY: Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve a new information collection requirement. DATES: Submit comments on or before April 17, 2023. ADDRESSES: Submit comments identified by Information Collection 3090–XXXX; Overseas Employment Agreement; GSA Form 5040 to: https:// www.regulations.gov. Submit comments via the Federal eRulemaking portal by searching for ‘‘Information Collection 3090–XXXX; Overseas Employment Agreement; GSA Form 5040’’. Select the link ‘‘Submit a Comment’’ that corresponds with ‘‘Information Collection 3090–XXXX; Overseas Employment Agreement; GSA Form 5040’’. Follow the instructions provided at the ‘‘Submit a Comment’’ screen. Please include your name, company name (if any), and ‘‘Information Collection 3090–XXXX; Overseas Employment Agreement; GSA Form 5040’’ on your attached document. If your comment cannot be submitted using https://www.regulations.gov, call or email the points of contact in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions. Instructions: Please submit comments only and cite Information Collection 3090–XXXX; Overseas Employment Agreement; GSA Form 5040, in all correspondence related to this collection. Comments received generally will be posted without change to https:// www.regulations.gov, including any personal and/or business confidential ddrumheller on DSK120RN23PROD with NOTICES SUMMARY: VerDate Sep<11>2014 20:12 Feb 13, 2023 Jkt 259001 information provided. To confirm receipt of your comment(s), please check www.regulations.gov, approximately two-to-three days after submission to verify posting. FOR FURTHER INFORMATION CONTACT: Colin C. Bennett, Human Resources Specialist, Office of Human Resources Management, Division of Human Capital Policy and Programs, at telephone 240–418–6822 or via email to colin.bennett@gsa.gov for clarification of content. SUPPLEMENTARY INFORMATION: The General Services Administration routinely hires, reassigns, promotes or transfers Federal employees to duty stations in foreign areas (i.e., outside of the United States and its territories and possessions). Under the Administrative Expenses Act of 1946 (60 Stat. 808), as amended, agencies are permitted to use appropriated funds to pay for the various costs incurred for permanent change of station (PCS) to the foreign area (see further 5 U.S.C. 5722 et. seq.). Such costs include: (1) travel expenses of the new appointee (or employee) and transportation expenses of his or her immediate family and his household goods and personal effects from the place of actual residence at the time of appointment to the place of employment outside the continental United States; (2) these expenses on the return of an employee from his post of duty outside the continental United States to the place of his actual residence at the time of assignment to duty outside the continental United States; and (3) the expenses of transporting a privately owned motor vehicle as authorized under 5 U.S.C. 5727(c). Under this authority, in return for this travel and transportation benefit, the appointee (or employee) must remain in the agency’s service for 12 months (1 year). More information concerning this statutory requirement is found within the GSA Government Travel Regulations at 41 CFR part 302– 3, subpart F. In order to more effectively memorialize the agency costs incurred, and the appointee’s (or employee’s) resulting service obligation, GSA has redeveloped its existing form GSA 5040. The intent is for this form to be used: (1) as an information collection device to memorialize compensation, foreign allowance, and travel and transportation benefits provided, and (2) as an enforceable service agreement for PCS travel and transportation costs, pursuant to the Federal Claims Collection Act of 1966 and the Debt Collection Act PO 00000 Frm 00096 Fmt 4703 Sfmt 4703 9521 Amendments of 1996 (see further 31 U.S.C. 3711 et. seq.) B. Annual Reporting Burden Respondents: 25 per year. Responses per Respondent: 1. Total Annual Responses: 25. Hours per Response: 1. Total Burden Hours: 25. C. Public Comments Public comments are particularly invited on: Whether this collection of information is necessary, whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology. Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the Regulatory Secretariat Division by calling 202–501–4755 or emailing GSARegSec@gsa.gov. Please cite OMB Control No. 3090–XXXX, Overseas Employment Agreement; GSA Form 5040, in all correspondence. Beth Anne Killoran, Deputy Chief Information Officer. [FR Doc. 2023–03131 Filed 2–13–23; 8:45 am] BILLING CODE 6820–FM–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2013–N–0134; FDA– 2016–D–2565; FDA–2013–N–0514; FDA– 2015–N–0030; FDA–2021–N–0584; FDA– 2021–N–1026; FDA–2013–N–0557; FDA– 2014–N–0053; FDA–2013–N–0190; FDA– 2019–N–0305; FDA–2019–N–2854; FDA– 2019–N–5553; FDA–2017–D–0085; FDA– 2016–N–2544; FDA–2019–N–2778; FDA– 2012–N–0977; FDA–2010–D–0319; and FDA–2018–N–3728] Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of SUMMARY: E:\FR\FM\14FEN1.SGM 14FEN1 9522 Federal Register / Vol. 88, No. 30 / Tuesday, February 14, 2023 / Notices Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796– 3794, PRAStaff@fda.hhs.gov. The following is a list of FDA information collections recently approved by OMB under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting SUPPLEMENTARY INFORMATION: statements for the information collections are available on the internet at https://www.reginfo.gov/public/do/ PRAMain. 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. TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB OMB control No. Title of collection Mammography Standards Quality Act Requirements ............................................................................................. 510(k) Third-Party Review Program ........................................................................................................................ Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization ................ Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act ...... Pilot to Develop Standardized Reporting Forms for Federally Funded Public Health Projects and Agreements Text Analysis of Proprietary Drug Name Interpretations ........................................................................................ Postmarket Surveillance of Medical Devices .......................................................................................................... Establishment, Maintenance, and Availability of Records; Additional Traceability Records for Certain Foods ..... Warning Plans for Smokeless Tobacco Products ................................................................................................... Deeming Tobacco Products To Be Subject to the FD&C Act ................................................................................ Premarket Tobacco Product Applications and Recordkeeping Requirements ....................................................... Right to Try Act: Reporting Requirements .............................................................................................................. Substances Generally Recognized as Safe: Best Practices for Convening a GRAS Panel .................................. Medical Devices—Quality System Regulation; 21 CFR part 820 ........................................................................... Threshold of Regulation for Substances Used in Food-Contact Articles ............................................................... Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents ................................................................................................................................................... Mailing of Important Information About Drugs ........................................................................................................ Collection of Conflict of Interest Information for Participation in Food and Drug Administration Non-Employee Fellowship and Traineeship Programs ................................................................................................................ Dated: February 8, 2023. Lauren K. Roth, Associate Commissioner for Policy. patent which claims that human drug product. BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2018–E–3051 and FDA– 2018–E–3095] Determination of Regulatory Review Period for Purposes of Patent Extension; ALIQOPA AGENCY: Notice. The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ALIQOPA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a ddrumheller on DSK120RN23PROD with NOTICES SUMMARY: VerDate Sep<11>2014 20:12 Feb 13, 2023 Jkt 259001 You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https:// www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of April 17, 2023. Comments received by mail/hand delivery/courier (for written/ paper submissions) will be considered timely if they are received on or before that date. ADDRESSES: Food and Drug Administration, HHS. ACTION: Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by April 17, 2023. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by August 14, 2023. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. DATES: [FR Doc. 2023–03073 Filed 2–13–23; 8:45 am] Electronic Submissions Submit electronic comments in the following way: PO 00000 Frm 00097 Fmt 4703 Sfmt 4703 Date approval expires 0910–0309 0910–0375 0910–0607 0910–0800 0910–0909 0910–0910 0910–0449 0910–0560 0910–0671 0910–0768 0910–0879 0910–0893 0910–0911 0910–0073 0910–0298 11/30/2025 11/30/2025 11/30/2025 11/30/2025 11/30/2025 11/30/2025 12/31/2025 12/31/2025 12/31/2025 12/31/2025 12/31/2025 12/31/2025 12/31/2025 1/31/2026 1/31/2026 0910–0312 0910–0754 1/31/2026 1/31/2026 0910–0882 1/31/2026 • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets E:\FR\FM\14FEN1.SGM 14FEN1

Agencies

[Federal Register Volume 88, Number 30 (Tuesday, February 14, 2023)]
[Notices]
[Pages 9521-9522]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03073]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2013-N-0134; FDA-2016-D-2565; FDA-2013-N-0514; FDA-
2015-N-0030; FDA-2021-N-0584; FDA-2021-N-1026; FDA-2013-N-0557; FDA-
2014-N-0053; FDA-2013-N-0190; FDA-2019-N-0305; FDA-2019-N-2854; FDA-
2019-N-5553; FDA-2017-D-0085; FDA-2016-N-2544; FDA-2019-N-2778; FDA-
2012-N-0977; FDA-2010-D-0319; and FDA-2018-N-3728]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approvals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is publishing a list of 
information collections that have been approved by the Office of

[[Page 9522]]

Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[email protected].

SUPPLEMENTARY INFORMATION: The following is a list of FDA information 
collections recently approved by OMB under section 3507 of the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control 
number and expiration date of OMB approval for each information 
collection are shown in table 1. Copies of the supporting statements 
for the information collections are available on the internet at 
https://www.reginfo.gov/public/do/PRAMain. 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.

        Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
                                            OMB control    Date approval
           Title of collection                  No.           expires
------------------------------------------------------------------------
Mammography Standards Quality Act              0910-0309      11/30/2025
 Requirements...........................
510(k) Third-Party Review Program.......       0910-0375      11/30/2025
Administrative Procedures for Clinical         0910-0607      11/30/2025
 Laboratory Improvement Amendments of
 1988 Categorization....................
Human Drug Compounding Under Sections          0910-0800      11/30/2025
 503A and 503B of the Federal Food,
 Drug, and Cosmetic Act.................
Pilot to Develop Standardized Reporting        0910-0909      11/30/2025
 Forms for Federally Funded Public
 Health Projects and Agreements.........
Text Analysis of Proprietary Drug Name         0910-0910      11/30/2025
 Interpretations........................
Postmarket Surveillance of Medical             0910-0449      12/31/2025
 Devices................................
Establishment, Maintenance, and                0910-0560      12/31/2025
 Availability of Records; Additional
 Traceability Records for Certain Foods.
Warning Plans for Smokeless Tobacco            0910-0671      12/31/2025
 Products...............................
Deeming Tobacco Products To Be Subject         0910-0768      12/31/2025
 to the FD&C Act........................
Premarket Tobacco Product Applications         0910-0879      12/31/2025
 and Recordkeeping Requirements.........
Right to Try Act: Reporting Requirements       0910-0893      12/31/2025
Substances Generally Recognized as Safe:       0910-0911      12/31/2025
 Best Practices for Convening a GRAS
 Panel..................................
Medical Devices--Quality System                0910-0073       1/31/2026
 Regulation; 21 CFR part 820............
Threshold of Regulation for Substances         0910-0298       1/31/2026
 Used in Food-Contact Articles..........
Regulations Restricting the Sale and           0910-0312       1/31/2026
 Distribution of Cigarettes and
 Smokeless Tobacco to Protect Children
 and Adolescents........................
Mailing of Important Information About         0910-0754       1/31/2026
 Drugs..................................
Collection of Conflict of Interest             0910-0882       1/31/2026
 Information for Participation in Food
 and Drug Administration Non-Employee
 Fellowship and Traineeship Programs....
------------------------------------------------------------------------


    Dated: February 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03073 Filed 2-13-23; 8:45 am]
BILLING CODE 4164-01-P


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