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Home » 2023 Issues » 88 FR (02/14/2023) » 2023-03073. Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals

  2023-03073. Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals  

  • Start Preamble

    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 Start Printed Page 9522 Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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    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.

    End Further Info End Preamble Start Supplemental Information

    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

    Title of collectionOMB control No.Date approval expires
    Mammography Standards Quality Act Requirements0910-030911/30/2025
    510(k) Third-Party Review Program0910-037511/30/2025
    Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization0910-060711/30/2025
    Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act0910-080011/30/2025
    Pilot to Develop Standardized Reporting Forms for Federally Funded Public Health Projects and Agreements0910-090911/30/2025
    Text Analysis of Proprietary Drug Name Interpretations0910-091011/30/2025
    Postmarket Surveillance of Medical Devices0910-044912/31/2025
    Establishment, Maintenance, and Availability of Records; Additional Traceability Records for Certain Foods0910-056012/31/2025
    Warning Plans for Smokeless Tobacco Products0910-067112/31/2025
    Deeming Tobacco Products To Be Subject to the FD&C Act0910-076812/31/2025
    Premarket Tobacco Product Applications and Recordkeeping Requirements0910-087912/31/2025
    Right to Try Act: Reporting Requirements0910-089312/31/2025
    Substances Generally Recognized as Safe: Best Practices for Convening a GRAS Panel0910-091112/31/2025
    Medical Devices—Quality System Regulation; 21 CFR part 8200910-00731/31/2026
    Threshold of Regulation for Substances Used in Food-Contact Articles0910-02981/31/2026
    Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents0910-03121/31/2026
    Mailing of Important Information About Drugs0910-07541/31/2026
    Collection of Conflict of Interest Information for Participation in Food and Drug Administration Non-Employee Fellowship and Traineeship Programs0910-08821/31/2026
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    Dated: February 8, 2023.

    Lauren K. Roth,

    Associate Commissioner for Policy.

    End Signature End Supplemental Information

    [FR Doc. 2023-03073 Filed 2-13-23; 8:45 am]

    BILLING CODE 4164-01-P

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Document Information

Published:
02/14/2023
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
2023-03073
Pages:
9521-9522 (2 pages)
Docket Numbers:
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
PDF File:
2023-03073.pdf
Supporting Documents:
» Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
» Memorandum to FDA DMS on PMTA Final Rule (Docket No. FDA-2019-N-2854) re: Premarket Tobacco Product Applications and Recordkeeping Requirements
» Request for Extension of the Comment Period
» Transcript 10-30-19 All Tribes Call Proposed PMTA Rule
» PRIA Reference 4 - Deeming Tobacco Products - Final Regulatory Impact Analysis, 2016
» PRIA Reference 1 - Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act Final Rule,2016
» Reference 106 - Nicotine Levels and Presence of Selected Tobacco-Derived Toxins in Tobacco Flavoured, 2015
» Reference 95 - pH Changes in Smokeless Tobaccos Undergoing Nitrosation During Prolonged Storage, 1993
» Reference 98 - Microbial Community Structure and Dynamics of Dark Fire-Cured Tobacco Fermentation, 2007
» Reference 85 - The Role of Oral Controlled Release Matrix Tablets in Drug Delivery Systems, 2012