Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals

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Federal RegisterOct 1, 2021
86 Fed. Reg. 54457 (Oct. 1, 2021)

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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, PRAStaff@fda.hhs.gov.

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

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

Dated: September 24, 2021.

Lauren K. Roth,

Acting Principal Associate Commissioner for Policy.

[FR Doc. 2021-21386 Filed 9-30-21; 8:45 am]

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