Document ID: FDA-2012-N-0247-0005
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Announcement of Office of
Management and Budget Approval; Guidance for Industry on Formal
Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products
Posted Date: 2016-02-12T05:00Z

[Federal Register Volume 81, Number 29 (Friday, February 12, 2016)]
[Notices]
[Page 7549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02889]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0247]

Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Guidance for Industry on Formal 
Meetings With Sponsors and Applicants for Prescription Drug User Fee 
Act Products

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 Formal 
Meetings With Sponsors and Applicants for Prescription Drug User Fee 
Act Products'' 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 October 21, 2015, the Agency submitted a 
proposed collection of information entitled ``Guidance for Industry on 
Formal Meetings With Sponsors and Applicants for Prescription Drug User 
Fee Act Products'' 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 0910-0429. 
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: February 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-02889 Filed 2-11-16; 8:45 am]
 BILLING CODE 4164-01-P