2017-17871. 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, FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 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 No.	Date approval expires
Premarket Notification Submission 510(k), Subpart E	0910-0120	6/30/2020
Institutional Review Boards	0910-0130	6/30/2020
Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions	0910-0233	6/30/2020
Adverse Event Program for Medical Devices (Medical Product Safety Network (MedSun))	0910-0471	6/30/2020
Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products	0910-0543	6/30/2020
Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act	0910-0679	6/30/2020
Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion	0910-0681	6/30/2020
Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act	0910-0762	6/30/2020
Certification of Identity for Freedom of Information Act and Privacy Act Requests	0910-0832	6/30/2020
FDA Advisory Committee Membership Nominations	0910-0833	6/30/2020

Dated: August 18, 2017.

Leslie Kux,

Associate Commissioner for Policy.