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

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 R...

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Department of Health and Human Services
Food and Drug Administration
  1. [Docket Nos. FDA-2018-N-3442; FDA-2013-N-0557; FDA-2013-N-0514; FDA-2013-N-0190; FDA-2013-N-1428; FDA-2019-N-0075; FDA-2016-N-2544; FDA-2019-N-2778; FDA-2012-N-0977; FDA-2013-N-0823; FDA-2009-N-0380; FDA-2013-N-1147; FDA-2010-N-0117; FDA-2010-D-0350; FDA-2010-D-0319; FDA-2012-D-0530; and FDA-2016-N-2683]

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:

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, .

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 number Date approval expires
Web-Based Pilot Survey to Assess Allergy to Cosmetics in the United States 0910-0881 1/31/2021
Postmarket Surveillance of Medical Devices 0910-0449 11/30/2022
Administrative Procedures for Clinical Laboratory Improvement Amendments Categorization 0910-0607 11/30/2022
( printed page 5447)
Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as Amended by the Family Smoking Prevention and Tobacco Control Act 0910-0671 11/30/2022
Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act 0910-0827 11/30/2022
Experimental Study on Measuring Consumer Comprehension of Displays of Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke 0910-0880 11/30/2022
Medical Devices; Current Good Manufacturing Practice Quality System Regulation 0910-0073 12/31/2022
Threshold of Regulation for Substances Used in Food-Contact Articles 0910-0298 12/31/2022
Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents 0910-0312 12/31/2022
Format and Content Requirements for Over-the-Counter Drug Product Labeling 0910-0340 12/31/2022
Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications 0910-0523 12/31/2022
Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition 0910-0541 12/31/2022
Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims 0910-0670 12/31/2022
Guidance for Tobacco Retailers on Tobacco Retailer Training Programs 0910-0745 12/31/2022
Dear Health Care Provider Letters: Improving Communication of Important Safety Information 0910-0754 12/31/2022
Requests for Feedback on Medical Device Submissions 0910-0756 12/31/2022
Data to Support Social and Behavioral Research as Used by the Food and Drug Administration 0910-0847 12/31/2022

Dated: January 24, 2020.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.

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

BILLING CODE 4164-01-P

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85 FR 5446

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“Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,” thefederalregister.org (January 30, 2020), https://thefederalregister.org/documents/2020-01655/agency-information-collection-activities-announcement-of-office-of-management-and-budget-approvals.