2018-10281. 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
Medical Devices; Humanitarian Use Devices	0910-0332	3/31/2021
Medical Devices; Device Tracking	0910-0442	3/31/2021
Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine	0910-0566	3/31/2021
Certification to Accompany Drug, Biological Product, and Device Applications or Submissions (Form FDA 3674)	0910-0616	3/31/2021
Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics	0910-0850	3/31/2021
Food and Drug Administration Recall Regulations	0910-0249	4/30/2021

Dated: May 9, 2018.

Leslie Kux,

Associate Commissioner for Policy.