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Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals

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Food and Drug Administration, HHS.




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.

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FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852,

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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​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 collectionOMB control No.Date approval expires
Investigational New Drug Regulations0910-00142/28/2019
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Guidance for Industry on Formal Dispute Resolutions; Appeals Above the Division Level0910-04302/28/2019
SPF Labeling and Testing Requirements for OTC Sunscreen Products0910-07172/28/2019
Generic Drug User Fee Cover Sheet—Form FDA 37940910-07272/28/2019
Environmental Impact Considerations0910-03224/30/2019
FDA Adverse Event Reports; Electronic Submissions0910-06455/31/2019
Importer's Entry Notice0910-00466/30/2019
Exports: Notification and Recordkeeping Requirements0910-04826/30/2019
Focused Mitigation Strategies to Protect Food Against Intentional Adulteration0910-08126/30/2019
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Dated: August 5, 2016.

Jeremy Sharp,

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

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[FR Doc. 2016-19021 Filed 8-9-16; 8:45 am]