Document ID: FDA-2009-N-0511-0006
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Announcement of Office of
Management and Budget Approvals
Posted Date: 2016-12-14T05:00Z

[Federal Register Volume 81, Number 240 (Wednesday, December 14, 2016)]
[Notices]
[Page 90363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-30035]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2013-N-0375; FDA-2013-N-0370; FDA-2013-N-0134; FDA-
2009-N-0511; FDA-1997-N-0020; FDA-2011-N-0902; FDA-2013-N-0662; FDA-
2013-N-0450; FDA-2012-N-0477; FDA-2013-N-0519]

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.

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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Agreement for Shipments of Devices for         0910-0131       9/30/2019
 Sterilization..........................
Export of Medical Devices--Foreign             0910-0264       9/30/2019
 Letters of Approval....................
Mammography Facilities, Standards, and         0910-0309       9/30/2019
 Lay Summaries for Patients.............
Medicated Fee Mill License Application..       0910-0337       9/30/2019
Substances Generally Recognized as Safe:       0910-0342       9/30/2019
 Notification Procedure.................
Prescription Drug Product Labeling;            0910-0393       9/30/2019
 Medication Guide Requirements..........
Applications for FDA Approval to Market        0910-0513       9/30/2016
 a New Drug: Patent Submission and
 Listing Requirements and Application of
 30-month Stays on Approval of
 Abbreviated New Drug Applications
 Certifying That a Patent Claiming a
 Drug is Invalid or Will Not be
 Infringed..............................
Substances Prohibited from Use in Animal       0910-0339      10/31/2019
 Food or Feed; Animal Proteins
 Prohibited in Ruminant Feed............
Investigational Device Exemptions              0910-0078      11/30/2019
 Reports and Records--21 CFR 812........
Guidance for Industry on How to Submit         0910-0454      11/30/2019
 Information in Electronic Format to the
 Center for Veterinary Medicine Using
 the FDA Electronic Submission Gateway..
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    Dated: December 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-30035 Filed 12-13-16; 8:45 am]
 BILLING CODE 4164-01-P