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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
Food Labeling: Notification Procedures for Statements on Dietary Supplements0910-03316/30/2019
PHS Guideline on Infectious Disease Issues in Xenotransplantation0910-04566/30/2019
MDUFMA Small Business Qualification Certification0910-05086/30/2019
Electronic Submission of Medical Device Registration and Listing0910-06256/30/2019
Guidance for Industry on Q & A Regarding Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement & Nonprescription Drug Consumer Protection Act0910-06416/30/2019
Antimicrobial Animal Drug Distribution Reports and Recordkeeping0910-06596/30/2019
Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring0910-07336/30/2019
Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act0910-07346/30/2019
Accreditation of Third Party Certification Bodies to Conduct Food Safety Audits and Issue Certifications0910-07506/30/2019
Sanitary Transportation of Human and Animal Food0910-07736/30/2019
National Panel of Tobacco Consumer Studies0910-08156/30/2019
Standards for the Growing, Harvesting, Packaging, and Holding of Produce for Human Consumption0910-08166/30/2019
Hearing, Aging, and Direct-to-Consumer Television Advertisements0910-08186/30/2019
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Dated: July 6, 2016.

Leslie Kux,

Associate Commissioner for Policy.

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[FR Doc. 2016-16349 Filed 7-8-16; 8:45 am]

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