Document ID: FDA-2014-D-1167-0014
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Guidance for Industry on Controlled Correspondence Related to Generic Drug Development
Posted Date: 2015-10-30T04:00Z

[Federal Register Volume 80, Number 210 (Friday, October 30, 2015)]
[Notices]
[Page 66910]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27741]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1167]

Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Guidance for Industry on Controlled 
Correspondence Related to Generic Drug Development

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 
Controlled Correspondence Related to Generic Drug Development'' 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 July 9, 2015, the Agency submitted a 
proposed collection of information entitled ``Guidance for Industry on 
Controlled Correspondence Related to Generic Drug Development'' 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 0910-0797. 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 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27741 Filed 10-29-15; 8:45 am]
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