[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, [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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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]
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