Document ID: FDA-2011-N-0915-0006
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Announcement of Office of
Management and Budget Approval; Guidance for Industry on
Postmarketing Adverse Event Reporting for Nonprescription Human
Drug Products Marketed Without an Approved Application
Posted Date: 2016-02-03T05:00Z

[Federal Register Volume 81, Number 22 (Wednesday, February 3, 2016)]
[Notices]
[Page 5764]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01885]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0915]

Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Guidance for Industry on 
Postmarketing Adverse Event Reporting for Nonprescription Human Drug 
Products Marketed Without an Approved Application

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 for Industry on 
Postmarketing Adverse Event Reporting for Nonprescription Human Drug 
Products Marketed Without an Approved Application'' 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 July 2, 2015, the Agency submitted a 
proposed collection of information entitled ``Guidance for Industry on 
Postmarketing Adverse Event Reporting for Nonprescription Human Drug 
Products Marketed Without an Approved Application'' 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 0910-0636. The approval expires on December 31, 2018. 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 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01885 Filed 2-2-16; 8:45 am]
 BILLING CODE 4164-01-P