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:
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
