Document ID: FDA-2014-D-2138-0016
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Announcement of Office of
Management and Budget Approval; Guidance for Industry on Adverse
Event Reporting for Outsourcing Facilities
Posted Date: 2015-10-29T04:00Z

[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, PRAStaff@fda.hhs.gov.

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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