2018-22101. 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, [e-mail].

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 number	Date approval expires
New Animal Drugs for Investigational Use	0910-0117	8/31/2021
Guidance for Industry and FDA Staff, Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle	0910-0594	8/31/2021
Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements	0910-0608	8/31/2021
Prescription Drug Advertisements	0910-0686	8/31/2021
Survey of the Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types	0910-0744	8/31/2021
Permanent Discontinuation or Interruption in Manufacturing of Certain Drug and Biological Products	0910-0759	8/31/2021
Food and Cosmetic Export Certificate Applications Process	0910-0793	8/31/2021
Guidance for Industry: Medical Product Communications That are Consistent With the Food and Drug Administration Required Labeling—Questions and Answers	0910-0856	8/31/2021
Guidance for Industry: Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities Questions and Answers	0910-0857	8/31/2021
Guidance for Industry: Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other Entities	0910-0858	8/31/2021
Drug Supply Chain Security Act Pilot Program	0910-0859	8/31/2021
Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional and Retail Food Stores and Facility Types (2015-2025)	0910-0799	9/30/2021

Dated: October 4, 2018.

Leslie Kux,

Associate Commissioner for Policy.