Notice2023-03073
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 14, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 88 Issue 30 (Tuesday, February 14, 2023)</title>
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[Federal Register Volume 88, Number 30 (Tuesday, February 14, 2023)]
[Notices]
[Pages 9521-9522]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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.
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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,
<a href="/cdn-cgi/l/email-protection#4b1b190a183f2a2d2d0b2d2f2a65232338652c243d"><span class="__cf_email__" data-cfemail="9fcfcddeccebfef9f9dff9fbfeb1f7f7ecb1f8f0e9">[email protected]</span></a>.
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
<a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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
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OMB control Date approval
Title of collection No. expires
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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....
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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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