Document ID: FDA-2013-N-0523-0010
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals
Posted Date: 2018-04-09T04:00Z

[Federal Register Volume 83, Number 68 (Monday, April 9, 2018)]
[Notices]
[Pages 15152-15153]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07146]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2014-N-0075; FDA-2011-N-0015; FDA-2011-N-0076; FDA-
2017-N-0932; FDA-2016-N-4487; FDA-2014-N-0345; FDA-2013-N-0523; FDA-
2017-N-2428; FDA-2008-N-0312; and FDA-2014-N-1072]

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 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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Good Laboratory Practice Regulations for       0910-0119       1/31/2021
 Nonclinical Studies....................
Orphan Drug Designation Request Form and       0910-0167       1/31/2021
 The Common European Medicines Agency/
 Food and Drug Administration Form for
 Orphan Medicinal Product Designation...
Electronic Records: Electronic                 0910-0303       1/31/2021
 Signatures.............................
Experimental Study on Warning Statements       0910-0848       1/31/2021
 for Cigarette Graphic Health Warnings..

[[Page 15153]]

 
Consumer and Healthcare Professional           0910-0849       1/31/2021
 Identification of and Responses to
 Deceptive Prescription Drug Promotion..
Data to Support Drug Product                   0910-0695       2/28/2021
 Communications.........................
Applications for FDA Approval to Market        0910-0001       3/31/2021
 a New Drug.............................
Animal Drug Adverse Event Reporting and        0910-0284       3/31/2021
 Recordkeeping..........................
Extralabel Drug Use in Animals..........       0910-0325       3/31/2021
Application for Participation in FDA           0910-0780       3/31/2021
 Fellowship Programs....................
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    Dated: April 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07146 Filed 4-6-18; 8:45 am]
 BILLING CODE 4164-01-P