81 FR 7549 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 29 (February 12, 2016)

Page Range7549-7549
FR Document2016-02889

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.

Federal Register, Volume 81 Issue 29 (Friday, February 12, 2016)
[Federal Register Volume 81, Number 29 (Friday, February 12, 2016)]
[Notices]
[Page 7549]
From the Federal Register Online  [www.thefederalregister.org]
[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, [email protected].

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


Current View
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation81 FR 7549 

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