2016-19021. 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:

FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [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 http://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
Investigational New Drug Regulations	0910-0014	2/28/2019
Guidance for Industry on Formal Dispute Resolutions; Appeals Above the Division Level	0910-0430	2/28/2019
SPF Labeling and Testing Requirements for OTC Sunscreen Products	0910-0717	2/28/2019
Generic Drug User Fee Cover Sheet—Form FDA 3794	0910-0727	2/28/2019
Environmental Impact Considerations	0910-0322	4/30/2019
FDA Adverse Event Reports; Electronic Submissions	0910-0645	5/31/2019
Importer's Entry Notice	0910-0046	6/30/2019
Exports: Notification and Recordkeeping Requirements	0910-0482	6/30/2019
Focused Mitigation Strategies to Protect Food Against Intentional Adulteration	0910-0812	6/30/2019

Dated: August 5, 2016.

Jeremy Sharp,

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