2019-23251. 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 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 (PRA).

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 http://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
Physician Interpretation of Information About Prescription Drugs in Scientific Publications Versus Promotional Pieces	0910-0875	9/30/2021
Guidance on Meetings with Industry and Investigators on the Research and Development of Tobacco Products	0910-0731	8/31/2022
Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act	0910-0732	8/31/2022
Tobacco Products, User Fees, Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco	0910-0749	8/31/2022
Guidance for Industry on Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007	0910-0775	8/31/2022
Medicated Feed Mill License Application	0910-0337	9/30/2022
Guidance on Informed Consent for In Vitro Diagnostic Studies Using Leftover Human Specimens That Are Not Individually Identifiable	0910-0582	9/30/2022
Manufactured Food Regulatory Program Standards	0910-0601	9/30/2022
Information to Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements	0910-0661	9/30/2022
Generic Clearance for Quick Turnaround Testing of Communication Effectiveness	0910-0876	9/30/2022

Dated: October 17, 2019.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.