2017-24121. 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 No.	Date approval expires
Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission to Information to a Master File in Support of Petitions; and Electronic Submission Using FDA 3053	0910-0016	9/30/2020
Voluntary Cosmetic Registration Program	0910-0027	9/30/2020
Radioactive Drug Research Committees	0910-0053	9/30/2020
FDA Safety Communication Readership Survey	0910-0341	9/30/2020
Medical Devices; Reports for Corrections and Removals	0910-0359	9/30/2020
Generic FDA Rapid Response Surveys	0910-0500	9/30/2020
Guidance for Industry: Pharmacogenomic Data Submissions	0910-0557	9/30/2020
Cosmetic Labeling Regulations	0910-0599	9/30/2020
Annual Reporting for Custom Device Exemption	0910-0767	9/30/2020
GFI: E6(R2) Good Clinical Practice; International Council for Harmonisation	0910-0843	9/30/2020
DeNovo Classification Process (Evaluation of Automatic Class II Designation)	0910-0844	9/30/2020

Dated: November 1, 2017.

Anna K. Abram,

Deputy Commissioner for Policy, Planning, Legislation, and Analysis.