Document ID: FDA-2010-N-0161-0011
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Announcement of Office of
Management and Budget Approvals
Posted Date: 2018-06-08T04:00Z

[Federal Register Volume 83, Number 111 (Friday, June 8, 2018)]
[Notices]
[Pages 26698-26699]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12338]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2011-N-0231; FDA-2014-N-0996; FDA-2010-N-0161; FDA-
2017-N-5624; FDA-2011-N-0085; FDA-2013-D-0575; and FDA-2016-N-3710]

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 
https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or 
sponsor, and a person is not required

[[Page 26699]]

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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Biological Products--General Records and       0910-0308       4/30/2021
 Postmarket Adverse Experience Reporting
Guidance for Industry: Fast Track, Drug        0910-0389       4/30/2021
 Development Programs--Designation,
 Development, and Application Review....
Export Certificates for FDA Regulated          0910-0498       4/30/2021
 Products under U.S.C. Sections 801(e)
 and 802................................
Content and Format of Labeling for Human       0910-0624       4/30/2021
 Prescription Drugs and Biologics;
 Requirements for Pregnancy and
 Lactation Labeling.....................
Guidance for Industry: Cooperative             0910-0629       4/30/2021
 Manufacturing Arrangements for Licensed
 Biologics..............................
Guidance of Industry: Expedited Programs       0910-0765       4/30/2021
 for Serious Conditions--Drugs and
 Biologics..............................
Evaluation of the Food and Drug                0910-0851       4/30/2021
 Administration's Point-of-Sale Campaign
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    Dated: June 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12338 Filed 6-7-18; 8:45 am]
 BILLING CODE 4164-01-P