2018-03128. 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
Temporary Marketing Permit Applications	0910-0133	11/30/2020
Establishing and Maintaining Lists of U.S. Milk Product Manufacturers/Processors with Interest in Exporting	0910-0509	11/30/2020
Channels of Trade Policy for Commodities with Residues of Pesticide Chemicals for Which Tolerances Have been Revoked, Suspended, or Modified by the EPA	0910-0562	11/30/2020
Medical Devices; Exception from General Requirements for Informed Consent	0910-0586	11/30/2020
Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile	0910-0614	11/30/2020
Prescription Drug Advertisements	0910-0686	11/30/2020
Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded	0910-0688	11/30/2020
Electronic Submission of Allegations of Regulatory Misconduct Associated with Medical Devices	0910-0769	11/30/2020
Providing Waiver-Related Materials in Accordance With the Guidance for Industry on Providing Post-Market Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format	0910-0771	11/30/2020
Data To Support Social and Behavioral Research as Used by the Food and Drug Administration	0910-0847	11/30/2020

Dated: February 9, 2018.

Leslie Kux,

Associate Commissioner for Policy.