2021-28362. Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals  

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

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    FOR FURTHER INFORMATION CONTACT:

    Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St, North Bethesda, MD 20852, 301-796-7726, PRAStaff@fda.hhs.gov.

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    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
    Medical Device User Fee Cover Sheet and Device Facility User Fee Cover Sheet0910-051110/31/2024
    Examination of Secondary Claim Disclosures and Biosimilar Disclosures in Prescription Drug Promotional Materials0910-090210/31/2024
    Medical Device Labeling Regulations0910-048511/30/2024
    Establishment and Operation of Clinical Trial Data Monitoring Committees0910-058111/30/2024
    Reports Intended to Demonstrate the Substantial Equivalence of a New Tobacco Product0910-067311/30/2024
    Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food and Food for Animals0910-075111/30/2024
    Federal-State Regulatory Program Standards0910-076011/30/2024
    Electronic User Fee Payment Form0910-080511/30/2024
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    Dated: December 27, 2021.

    Lauren K. Roth,

    Associate Commissioner for Policy.

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    [FR Doc. 2021-28362 Filed 12-29-21; 8:45 am]

    BILLING CODE 4164-01-P

Document Information

Published:
12/30/2021
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
2021-28362
Pages:
74417-74417 (1 pages)
Docket Numbers:
Docket Nos. FDA-2012-N-0536, FDA-2020-N-1307, FDA-2014-N-1048, FDA-2021-N-0356, FDA-2011-D-0147, FDA-2018-N-1857, FDA-2021-N-0341, and FDA-2015-N-1837
PDF File:
2021-28362.pdf
Supporting Documents:
» Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Labeling Regulations
» Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
» Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Labeling Regulations
» Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Labeling Regulations
» Agency Information Collection Activities; Proposals, Submissions, and Approvals: Announcement of Office of Management and Budget Approvals
» Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Labeling Regulations
» Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Labeling Regulations
» Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Device Labeling Regulations
» Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Labeling Regulations
» Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Labeling Regulations