Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; General Licensing Provisions; Section 351(k) Biosimilar Applications, 5467 [2016-01783]
Agencies
[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] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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, PRAStaff@fda.hhs.gov. 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 https://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
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