[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]
BILLING CODE 4164-01-P