2021-09811. 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 (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 PRA (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
Applications for FDA Approval to Market a New Drug	0910-0001	3/31/2024
Medical Devices; Humanitarian Use Devices	0910-0332	3/31/2024
Medical Devices; Device Tracking	0910-0442	3/31/2024
Dispute Resolution Procedures for Science Based Decision on Products Regulated by CVM	0910-0566	3/31/2024
Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics	0910-0850	3/31/2024
Assessment of Terms and Phrases Commonly Used in Prescription Drug Promotion	0910-0895	3/31/2024

Dated: May 4, 2021.

Lauren K. Roth,

Acting Principal Associate Commissioner for Policy.