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

May 4, 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

<html>
<head>
<title>Federal Register, Volume 88 Issue 86 (Thursday, May 4, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 86 (Thursday, May 4, 2023)]
[Notices]
[Pages 28562-28563]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-09401]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2022-N-1894; FDA-2018-N-3303; FDA-2022-N-0576; FDA-
2022-N-1794; FDA-2011-N-0902; FDA-2009-N-0545; FDA-2016-N-2474; FDA-
2010-D-0350; FDA-2012-D-0530; FDA-2016-N-2683; FDA-2013-N-0403; FDA-
2013-N-0134; FDA-2022-N-2440; FDA-2013-N-0879; and FDA-2014-N-1048]


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

[[Page 28563]]

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#d383819280a7b2b5b593b5b7b2fdbbbba0fdb4bca5"><span class="__cf_email__" data-cfemail="cb9b998a98bfaaadad8badafaae5a3a3b8e5aca4bd">[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
------------------------------------------------------------------------
Yale-Mayo Clinic Centers of Excellence         0910-0912       3/31/2024
 in Regulatory Science and Innovation
 B12 Pediatric Device Survey............
Electronic Products Requirements........       0910-0025       2/28/2026
Investigational Device Exemptions.......       0910-0078       2/28/2026
General Drug Labeling Provisions and OTC       0910-0340       2/28/2026
 Monograph Drug User Fee Submissions....
Prescription Drug Product Labeling;            0910-0393       2/28/2026
 Medication Guide Requirements..........
Reporting of Biological Product                0910-0458       2/28/2026
 Deviations and Human Cells, Tissues,
 and Cellular and Tissue-Based Product
 Deviations in Manufacturing............
Designation of New Animal Drugs for            0910-0605       2/28/2026
 Minor Use or Minor Species.............
Tobacco Retailer Training Programs......       0910-0745       2/28/2026
Q-Submission and Early Payor Feedback          0910-0756       2/28/2026
 Request Programs for Medical Devices...
Data To Support Social and Behavioral          0910-0847       2/28/2026
 Research as Used by the Food and Drug
 Administration.........................
Protection of Human Subjects and               0910-0130       3/31/2026
 Institutional Review Boards............
Mammography Standards Quality Act              0910-0309       3/31/2026
 Requirements...........................
Biologics License Applications;                0910-0338       3/31/2026
 Procedures & Requirements..............
Procedures for the Safe Processing and         0910-0354       3/31/2026
 Importing of Fish and Fishery Products.
Medical Device Labeling Regulations;           0910-0485       3/31/2026
 Unique Device Identification...........
------------------------------------------------------------------------


    Dated: April 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09401 Filed 5-3-23; 8:45 am]
BILLING CODE 4164-01-P


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>

View on FederalRegister.gov →Plain-text source

Indexed from Federal Register on May 4, 2023.

This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.