[Federal Register Volume 79, Number 143 (Friday, July 25, 2014)]
[Notices]
[Page 43494]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-17481]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-N-0220]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Guidance for Industry--
Pharmacogenomic Data Submissions

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--
Pharmacogenomic Data Submissions'' 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 May 9, 2014, the Agency submitted a 
proposed collection of information entitled ``Guidance for Industry--
Pharmacogenomic Data Submissions'' 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 
0910-0557. The approval expires on July 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: July 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-17481 Filed 7-24-14; 8:45 am]
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