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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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Ila S. Mizrachi, FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726,

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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
Importer's Entry Notice0910-004612/31/2019
Threshold of Regulation for Substances Used in Food-Contact Articles0910-029812/31/2019
Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents0910-031212/31/2019
Postmarket Surveillance of Medical Devices0910-044912/31/2019
Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications0910-052312/31/2019
Administrative Procedures for Clinical laboratory Improvement Amendments of 1988 Categorization (42 CFR 493.17)0910-060712/31/2019
Requirements under the Comprehensive Smokeless Tobacco Health Education Act of 1986; as amended by the Family Smoking Prevention and Tobacco Control Act0910-067112/31/2019
Guidance for Industry on Tobacco Retailer Training Programs0910-074512/31/2019
Animation in Direct-to-Consumer Advertising0910-082612/31/2019
Guidance for Industry: Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act0910-082712/31/2019
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Dated: May 18, 2017.

Anna K. Abram,

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

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[FR Doc. 2017-10711 Filed 5-24-17; 8:45 am]