Document ID: FDA-2009-N-0232-0009
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Posted Date: 2019-07-23T04:00Z

[Federal Register Volume 84, Number 141 (Tuesday, July 23, 2019)]
[Notices]
[Pages 35398-35399]
From the Federal Register Online via the Government Publishing Office [http://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