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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 No.Date approval expires
Obtaining Information to Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities0910-08831/31/2021
Protection of Human Subjects; Informed Consent; and Institutional Boards0910-01301/31/2023
Biological Products: Reporting and Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Deviations in Manufacturing0910-04581/31/2023
Reporting Associated with Designated New Animal Drugs for Minor Use and Minor Species0910-06051/31/2023
Evaluation of the Food and Drug Administration's General Market Youth Tobacco Prevention Campaign0910-07531/31/2023
Collection of Conflict of Interest Information for Participation in Food and Drug Administration Non-Employee Fellowship and Traineeship Programs0910-08821/31/2023
Human Tissue Intended for Transplantation0910-03022/28/2023
General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Form FDA 356h0910-03382/28/2023
Procedures for the Safe Processing and Importing of Fish and Fishery Products0910-03542/28/2023
Medical Devices; Shortages Data Collection System0910-04912/28/2023
Focus Groups About Drug Products as Used by the Food and Drug Administration0910-06772/28/2023
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Unique Device Identification System0910-07202/28/2023
Animal Feed Regulatory Program Standards0910-07602/28/2023
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Dated: March 11, 2020.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.

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[FR Doc. 2020-05354 Filed 3-16-20; 8:45 am]