Notice2021-21386

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 1, 2021

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA or Agency) 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 86 Issue 188 (Friday, October 1, 2021)</title>
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[Federal Register Volume 86, Number 188 (Friday, October 1, 2021)]
[Notices]
[Pages 54457-54458]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-21386]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-N-2231; FDA-2011-N-0362; FDA-2018-N-0073; FDA-
2018-N-0074; FDA-2010-N-0155; FDA-2011-N-0781; FDA-2021-N-0525; FDA-
2014-N-0987; FDA-2020-N-1657; FDA-2017-N-6931; FDA-2020-N-2217; FDA-
2012-N-0369; FDA-2017-N-6730; FDA-2020-N-1207; FDA-2012-N-0115; FDA-
2021-N-0363; FDA-2009-N-0025; FDA-2012-N-0547; FDA-2014-N-2347; FDA-
2018-N-1129; FDA-2021-N-0387; FDA-2020-N-1261; and FDA-2020-N-1644]


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 or Agency) 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#cc9c9e8d9fb8adaaaa8caaa8ade2a4a4bfe2aba3ba"><span class="__cf_email__" data-cfemail="104042514364717676507674713e7878633e777f66">[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.

[[Page 54458]]



        Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
                                            OMB control    Date approval
           Title of collection                  No.           expires
------------------------------------------------------------------------
Blood Establishment Registration and           0910-0052       7/31/2024
 Product Listing for Manufacturers of
 Blood and Blood Products and Licensed
 Devices................................
Current Good Manufacturing Practice:           0910-0139       7/31/2024
 Manufacturing, Processing, Packing, and
 Holding of Drugs; GMP for Finished
 Pharmaceuticals (Including Gases and
 Active Pharmaceutical Ingredients).....
Irradiation in the Production,                 0910-0186       7/31/2024
 Processing, and Handling of Food.......
State Enforcement Notifications.........       0910-0275       7/31/2024
Veterinary Feed Directive...............       0910-0363       7/31/2024
Record Retention Requirements for the          0910-0428       7/31/2024
 Soy Protein/Coronary Heart Disease
 Health Claim...........................
Prescription Drug Marketing:                   0910-0435       7/31/2024
 Administrative Procedures, Policies,
 and Requirements.......................
Generic Clearance for the Collection of        0910-0796       7/31/2024
 Qualitative Data on Tobacco Products
 and Communications.....................
Survey of Drug Product Manufacturing,          0910-0899       7/31/2024
 Processing, and Packing Facilities.....
Current Good Manufacturing Practices for       0910-0116       8/31/2024
 Blood and Related Regulations for Blood
 Components; and Requirements for Donor
 Testing, Donor Notification and
 ``Lookback''...........................
New Animal Drugs for Investigational Use       0910-0117       8/31/2024
Regulations Under the Federal Import           0910-0212       8/31/2024
 Milk Act...............................
Medical Device Reporting................       0910-0437       8/31/2024
New Plant Varieties Intended for Food          0910-0583       8/31/2024
 Use....................................
Guidance for Industry and FDA Staff;           0910-0594       8/31/2024
 Class II Special Controls: Automated
 Blood Cell Separator Device Operating
 by Centrifugal or Filtration Separation
 Principle..............................
Prescription Drug Advertisements........       0910-0686       8/31/2024
Animal Food Labeling; Declaration of           0910-0721       8/31/2024
 Certifiable Color Additives............
Survey on the Occurrence of Foodborne          0910-0744       8/31/2024
 Illness Risk Factors in Selected Retail
 and Food Service Facility Types........
Food and Cosmetic Export Certificates...       0910-0793       8/31/2024
National Agriculture and Food Defense          0910-0855       8/31/2024
 Strategy Survey........................
Medical Product Communications That are        0910-0856       8/31/2024
 Consistent With the Food and Drug
 Administration Required Labeling--
 Questions and Answers..................
Drug and Device Manufacturer                   0910-0857       8/31/2024
 Communications with Payors, Formulary
 Committees, and Similar Entities
 Questions and Answers..................
Study of Disclosures to Health Care            0910-0900       8/31/2024
 Providers Regarding Data That Do Not
 Support Unapproved Use of an Approved
 Prescription Drug......................
Medical Conference Attendees'                  0910-0901       8/31/2024
 Observations About Prescription Drug
 Promotion..............................
------------------------------------------------------------------------


    Dated: September 24, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21386 Filed 9-30-21; 8:45 am]
BILLING CODE 4164-01-P


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