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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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, PRAStaff@fda.hhs.gov.
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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 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 No.||Date approval
|Experimental Study of an Accelerated Approval Disclosure||0910-0872||6/30/2020|
|Interstate Shellfish Dealer's Certificate||0910-0021||5/31/2022|
|Administrative Detention and Banned Medical Devices||0910-0114||5/31/2022|
|Medical Device User Fee Small Business Qualifications and Certifications||0910-0508||5/31/2022|
|Start Printed Page 35399|
|Individual Patient Expanded Access Applications||0910-0814||5/31/2022|
|Electronic Forma for Submissions; Promotional labeling and Advertising Materials for Human Prescription Drugs||0910-0870||5/31/2022|
|Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation||0910-0456||6/30/2022|
|Electronic Submission of Medical Device Registration and Listing||0910-0625||6/30/2022|
|Antimicrobial Animal Drug Distribution Reports and Recordkeeping||0910-0659||6/30/2022|
|Obtaining Information for Evaluating Nominated Bulk Drug Substances for Use in Compounding Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act||0910-0871||6/30/2022|
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Dated: July 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15626 Filed 7-22-19; 8:45 am]
BILLING CODE 4164-01-P