Document ID: FDA-2018-N-1857-0012
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Posted Date: 2021-12-30T05:00Z

[Federal Register Volume 86, Number 248 (Thursday, December 30, 2021)]
[Notices]
[Page 74417]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-28362]

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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.

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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: 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, 
[email protected].

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
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                                            OMB control    Date approval
           Title of collection                  No.           expires
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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
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    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