79 FR 143 pg. 43494 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry—Pharmacogenomic Data Submissions

Type: NOTICEVolume: 79Number: 143Page: 43494
Docket number: [Docket No. FDA-2007-N-0220]
FR document: [FR Doc. 2014-17481 Filed 7-24-14; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version:  PDF Version
Page: 43494

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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.

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, PRAStaff@fda.hhs.gov.

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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