Notice2021-28362
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
December 30, 2021
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 86 Issue 248 (Thursday, December 30, 2021)</title>
</head>
<body><pre>
[Federal Register Volume 86, Number 248 (Thursday, December 30, 2021)]
[Notices]
[Page 74417]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-28362]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[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]
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 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: 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,
<a href="/cdn-cgi/l/email-protection#77272536240316111137111316591f1f0459101801"><span class="__cf_email__" data-cfemail="e9b9bba8ba9d888f8fa98f8d88c781819ac78e869f">[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
------------------------------------------------------------------------
OMB control Date approval
Title of collection No. expires
------------------------------------------------------------------------
Medical Device User Fee Cover Sheet and 0910-0511 10/31/2024
Device Facility User Fee Cover Sheet...
Examination of Secondary Claim 0910-0902 10/31/2024
Disclosures and Biosimilar Disclosures
in Prescription Drug Promotional
Materials..............................
Medical Device Labeling Regulations..... 0910-0485 11/30/2024
Establishment and Operation of Clinical 0910-0581 11/30/2024
Trial Data Monitoring Committees.......
Reports Intended to Demonstrate the 0910-0673 11/30/2024
Substantial Equivalence of a New
Tobacco Product........................
Current Good Manufacturing Practice and 0910-0751 11/30/2024
Hazard Analysis and Risk-Based
Preventive Controls for Human Food and
Food for Animals.......................
Federal-State Regulatory Program 0910-0760 11/30/2024
Standards..............................
Electronic User Fee Payment Form........ 0910-0805 11/30/2024
------------------------------------------------------------------------
Dated: December 27, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-28362 Filed 12-29-21; 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>Indexed from Federal Register on December 30, 2021.
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.