Document ID: FDA-2013-N-0663-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Announcement of Office of
Management and Budget Approval; Investigational New Drug Safety
Reporting Requirements for Human Drug and Biological Products and
Safety Reporting Requirements for Bioavailability and Bioequivalence
Studies in Humans
Posted Date: 2014-01-23T05:00Z

[Federal Register Volume 79, Number 15 (Thursday, January 23, 2014)]
[Notices]
[Page 3826]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-01310]

[[Page 3826]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0403]

Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Protection of Human Subjects: 
Informed Consent; Institutional Review Boards

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 ``Protection of Human Subjects: 
Informed Consent; Institutional Review Boards'' 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, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: On July 30, 2013, the Agency submitted a 
proposed collection of information entitled ``Protection of Human 
Subjects: Informed Consent; Institutional Review Boards'' 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 0910-0755. The approval expires on December 31, 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: January 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-01310 Filed 1-22-14; 8:45 am]
BILLING CODE 4160-01-P