Notice2023-22465

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
October 11, 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 195 (Wednesday, October 11, 2023)</title>
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[Federal Register Volume 88, Number 195 (Wednesday, October 11, 2023)]
[Notices]
[Pages 70422-70423]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-22465]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2013-N-0804; FDA-2010-N-0598; FDA-2022-N-0081; FDA-
2022-N-1886; FDA-2022-N-2657; FDA-2023-N-0895; FDA-2023-N-0343; FDA-
2023-N-0134; FDA-2022-N-3208; FDA-2017-N-0084; FDA-2023-N-1168; FDA-
2016-N-2474; FDA-2014-N-0086; FDA-2017-N-0366; FDA-2019-N-3657; FDA-
2023-N-0155; FDA-2010-N-0601; FDA-2023-N-2757]


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 
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#a8f8fae9fbdcc9cecee8ceccc986c0c0db86cfc7de"><span class="__cf_email__" data-cfemail="2b7b796a785f4a4d4d6b4d4f4a05434358054c445d">[email&#160;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
------------------------------------------------------------------------
                                            OMB control    Date approval
           Title of collection                  No.           expires
------------------------------------------------------------------------
Premarket Notification Submission              0910-0120       7/31/2026
 510(k), Subpart E......................
Good Manufacturing Practice Regulations        0910-0154       7/31/2026
 for Type A Medicated Articles..........
Tradeoff Analysis of Prescription Drug         0910-0917       7/31/2026
 Product Claims in Direct-to-Consumer
 and Healthcare Provider Promotion......
Endorser Status and Actual Use in Direct-      0910-0918       7/31/2026
 to-Consumer Television Ads.............
Assessing Physiological, Neural and Self-      0910-0919       7/31/2026
 Reported Response to Tobacco Education
 Messages...............................
Imports and Electronic Import Entries...       0910-0046       8/31/2026
Current Good Manufacturing Practices for       0910-0116       8/31/2026
 Blood and Related Regulations for and
 Blood Components; and Requirements for
 Donor Testing, Donor Notification, and
 ``Lookback''...........................
Administrative Practices and Procedures;       0910-0191       8/31/2026
 Formal Hearings........................
Adverse Experience/Events with Approved        0910-0284       8/31/2026
 New Animal Drugs.......................
Adverse Event Program for Medical              0910-0471       8/31/2026
 Devices (Medical Product Safety Network
 (MedSun))..............................
Human Cells, Tissues, and Cellular and         0910-0543       8/31/2026
 Tissue-Based Products..................
New Animal Drugs for Minor Use and Minor       0910-0605       8/31/2026
 Species................................
Potential Tobacco Product Violations           0910-0716       8/31/2026
 Reporting Form.........................
Food and Drug Administration Advisory          0910-0833       8/31/2026
 Committee Regulations..................
Accreditation Scheme for Conformity            0910-0889       8/31/2026
 Assessment Program.....................
Quantitative Research on Front of              0910-0920       8/31/2026
 Package Labeling on Packaged Foods.....
Current Good Manufacturing Practice            0910-0152       9/30/2026
 Regulations for Medicated Feed.........
Medical Devices--Voluntary Improvement         0910-0922       9/30/2026
 Program................................
------------------------------------------------------------------------



[[Page 70423]]

    Dated: October 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22465 Filed 10-10-23; 8:45 am]
BILLING CODE 4164-01-P


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Indexed from Federal Register on October 11, 2023.

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