Document ID: FDA-2013-D-1478-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Announcement of Office of
Management and Budget Approval; Providing Waiver-Related Materials in Accordance With Draft Guidance for Industry on Providing Postmarket
Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format
Posted Date: 2014-09-12T04:00Z

[Federal Register Volume 79, Number 177 (Friday, September 12, 2014)]
[Notices]
[Page 54728]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-21726]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1478]

Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Providing Waiver-Related Materials 
in Accordance With Draft Guidance for Industry on Providing Postmarket 
Periodic Safety Reports in the International Conference on 
Harmonisation E2C(R2) Format

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 Providing Waiver-Related Materials 
in Accordance with Draft Guidance for Industry on Providing 
``Postmarket Periodic Safety Reports in the International Conference on 
Harmonisation E2C(R2) Format'' 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 June 19, 2014, the Agency submitted a 
proposed collection of information entitled ``Providing Waiver-Related 
Materials in Accordance with Draft Guidance for Industry on Providing 
Postmarket Periodic Safety Reports in the International Conference on 
Harmonisation E2C(R2) Format'' 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 0910-0771. 
The approval expires on August 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: September 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-21726 Filed 9-11-14; 8:45 am]
BILLING CODE 4164-01-P