[Federal Register Volume 80, Number 209 (Thursday, October 29, 2015)]
[Notices]
[Page 66545]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27557]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-2138]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Guidance for Industry on Adverse
Event Reporting for Outsourcing Facilities
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Guidance for Industry on Adverse
Event Reporting for Outsourcing Facilities Under Section 503B of the
Federal Food, Drug and Cosmetic Act'' has 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, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, [email protected].
SUPPLEMENTARY INFORMATION: On August 4, 2015, the Agency submitted a
proposed collection of information entitled ``Guidance for Industry on
Adverse Event Reporting for Outsourcing Facilities Under Section 503B
of the Federal Food, Drug, and Cosmetic Act'' to OMB for review and
clearance under 44 U.S.C. 3507. 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. OMB has now
approved the information collection and has assigned OMB control number
0910-0800. The approval expires on September 30, 2018. A copy of the
supporting statement for this information collection is available on
the Internet at http://www.reginfo.gov/public/do/PRAMain.
Dated: October 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27557 Filed 10-28-15; 8:45 am]
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