Document ID: FDA-2012-N-0560-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens, etc.
Posted Date: 2013-05-10T04:00Z

[Federal Register Volume 78, Number 91 (Friday, May 10, 2013)]
[Notices]
[Page 27404]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-11125]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0560]

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, 
daniel.gittleson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: On February 11, 2013, the Agency submitted a 
proposed collection of information entitled ``Guidance on Informed 
Consent for In Vitro Diagnostic Device Studies Using Leftover Human 
Specimens That Are Not Individually Identifiable'' 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 April 30, 2016. 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 6, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-11125 Filed 5-9-13; 8:45 am]
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