[Federal Register Volume 81, Number 21 (Tuesday, February 2, 2016)]
[Notices]
[Page 5467]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01783]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0129]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; General Licensing Provisions; 
Section 351(k) Biosimilar Applications

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 ``General Licensing Provisions; 
Section 351(k) Biosimilar Applications'' 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 July 8, 2015, the Agency submitted a 
proposed collection of information entitled ``General Licensing 
Provisions; Section 351(k) Biosimilar Applications'' 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 0910-0719. 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 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01783 Filed 2-1-16; 8:45 am]
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