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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
Experimental Study of an Accelerated Approval Disclosure0910-08726/30/2020
Interstate Shellfish Dealer's Certificate0910-00215/31/2022
Administrative Detention and Banned Medical Devices0910-01145/31/2022
Medical Device User Fee Small Business Qualifications and Certifications0910-05085/31/2022
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Individual Patient Expanded Access Applications0910-08145/31/2022
Electronic Forma for Submissions; Promotional labeling and Advertising Materials for Human Prescription Drugs0910-08705/31/2022
Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation0910-04566/30/2022
Electronic Submission of Medical Device Registration and Listing0910-06256/30/2022
Antimicrobial Animal Drug Distribution Reports and Recordkeeping0910-06596/30/2022
Obtaining Information for Evaluating Nominated Bulk Drug Substances for Use in Compounding Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act0910-08716/30/2022
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Dated: July 16, 2019.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.

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[FR Doc. 2019-15626 Filed 7-22-19; 8:45 am]