Document ID: FDA-2010-D-0283-0031
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Announcement of Office of
Management and Budget Approval; Final Guidance for Industry on
Chemistry, Manufacturing, and Controls Postapproval Manufacturing
Changes To Be Documented in Annual Reports
Posted Date: 2014-02-18T05:00Z

[Federal Register Volume 79, Number 32 (Tuesday, February 18, 2014)]
[Notices]
[Page 9215]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03350]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0283]

Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Final Guidance for Industry on 
Chemistry, Manufacturing, and Controls Postapproval Manufacturing 
Changes To Be Documented in Annual Reports

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 ``Final Guidance for Industry on 
Chemistry, Manufacturing, and Controls Postapproval Manufacturing 
Changes to be Documented in Annual Reports '' 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, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: On November 6, 2013; the Agency submitted a 
proposed collection of information entitled ``Final Guidance for 
Industry on Chemistry, Manufacturing, and Controls Postapproval 
Manufacturing Changes to be Documented in Annual Reports'' 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 0910-0758. The approval expires on January 31, 2017. A 
copy of the supporting statement for this information collection is 
available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: February 10, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03350 Filed 2-14-14; 8:45 am]
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