[Federal Register Volume 84, Number 141 (Tuesday, July 23, 2019)]
[Notices]
[Pages 35398-35399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15626]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2018-N-3138; FDA-2009-N-0232; FDA-2018-N-4465; FDA-
2018-N-4206; FDA-2018-N-3758; FDA-2015-D-1163; FDA-2012-N-0559; FDA-
2015-N-3815; FDA-2018-N-3353; and FDA-2018-N-2973]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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,
[email protected].
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
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OMB control Date approval
Title of collection No. expires
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Experimental Study of an Accelerated 0910-0872 6/30/2020
Approval Disclosure....................
Interstate Shellfish Dealer's 0910-0021 5/31/2022
Certificate............................
Administrative Detention and Banned 0910-0114 5/31/2022
Medical Devices........................
Medical Device User Fee Small Business 0910-0508 5/31/2022
Qualifications and Certifications......
[[Page 35399]]
Individual Patient Expanded Access 0910-0814 5/31/2022
Applications...........................
Electronic Forma for Submissions; 0910-0870 5/31/2022
Promotional labeling and Advertising
Materials for Human Prescription Drugs.
Public Health Service Guideline on 0910-0456 6/30/2022
Infectious Disease Issues in
Xenotransplantation....................
Electronic Submission of Medical Device 0910-0625 6/30/2022
Registration and Listing...............
Antimicrobial Animal Drug Distribution 0910-0659 6/30/2022
Reports and Recordkeeping..............
Obtaining Information for Evaluating 0910-0871 6/30/2022
Nominated Bulk Drug Substances for Use
in Compounding Drug Products Under
Section 503B of the Federal Food, Drug,
and Cosmetic Act.......................
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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