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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, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 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 numberDate approval expires
Web-Based Pilot Survey to Assess Allergy to Cosmetics in the United States0910-08811/31/2021
Postmarket Surveillance of Medical Devices0910-044911/30/2022
Administrative Procedures for Clinical Laboratory Improvement Amendments Categorization0910-060711/30/2022
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Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as Amended by the Family Smoking Prevention and Tobacco Control Act0910-067111/30/2022
Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act0910-082711/30/2022
Experimental Study on Measuring Consumer Comprehension of Displays of Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke0910-088011/30/2022
Medical Devices; Current Good Manufacturing Practice Quality System Regulation0910-007312/31/2022
Threshold of Regulation for Substances Used in Food-Contact Articles0910-029812/31/2022
Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents0910-031212/31/2022
Format and Content Requirements for Over-the-Counter Drug Product Labeling0910-034012/31/2022
Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications0910-052312/31/2022
Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition0910-054112/31/2022
Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims0910-067012/31/2022
Guidance for Tobacco Retailers on Tobacco Retailer Training Programs0910-074512/31/2022
Dear Health Care Provider Letters: Improving Communication of Important Safety Information0910-075412/31/2022
Requests for Feedback on Medical Device Submissions0910-075612/31/2022
Data to Support Social and Behavioral Research as Used by the Food and Drug Administration0910-084712/31/2022
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Dated: January 24, 2020.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.

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[FR Doc. 2020-01655 Filed 1-29-20; 8:45 am]