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Federal Register: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance on Informed Consent for In Vitro Diagnostic Devi...

Thu, 05/13/2010 - 7:41am
U.S. Food & Drug Administration

[Federal Register: May 7, 2010 (Volume 75, Number 88)]

[Notices]

[Page 25268]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr07my10-100]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0487]

Agency Information Collection Activities; Announcement of Office

of Management and Budget Approval; Guidance on Informed Consent for In

Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are

Not Individually Identifiable

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 on Informed Consent For

In Vitro Diagnostic Device Studies Using Leftover Human Specimens That

Are Not Individually Identifiable'' has been approved by the Office of

Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of

Information Management, Food and Drug Administration, 1350 Piccard Dr.,

PI50-400B, Rockville, MD 20850, 301-796-5156, email:

Daniel.Gittleson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of January 19, 2010

(75 FR 2868), the agency announced that the proposed information

collection had been submitted 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 0910-0582.

The approval expires on February 28, 2013. A copy of the supporting

statement for this information collection is available on the Internet

at http://www.reginfo.gov/public/do/PRAMain.

Dated: May 4, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.

[FR Doc. 2010-10782 Filed 5-6-10; 8:45 am]

BILLING CODE 4160-01-S

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