Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Extra Label Drug Use in Animals, 27321 [2015-11526]

Download as PDF Federal Register / Vol. 80, No. 92 / Wednesday, May 13, 2015 / Notices Approved ANDAs that refer to the NDA listed in this document are unaffected by the discontinued marketing of the products subject to this NDA. Additional ANDAs that refer to these products may also be approved by the Agency if they comply with relevant legal and regulatory requirements. If FDA determines that labeling for these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: May 6, 2015. Leslie Kux, Associate Commissioner for Policy. Dated: May 7, 2015. Leslie Kux, Associate Commissioner for Policy. Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009; Draft Guidance for Industry; Availability [FR Doc. 2015–11529 Filed 5–12–15; 8:45 am] BILLING CODE 4164–01–P [FR Doc. 2015–11526 Filed 5–12–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–D–0611] AGENCY: DEPARTMENT OF HEALTH AND HUMAN SERVICES ACTION: [Docket No. FDA–2008–N–0312] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Extra Label Drug Use in Animals Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ‘‘Extra Label Drug Use in Animals’’ 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. SUMMARY: On February 18, 2015, the Agency submitted a proposed collection of information entitled, ‘‘Extra Label Drug Use in Animals’’ 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 0910–0325. The approval expires on March 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. asabaliauskas on DSK5VPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 17:27 May 12, 2015 Jkt 235001 Notice. The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ‘‘Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.’’ This draft guidance is intended to provide answers to common questions from sponsors interested in developing proposed biosimilar products, biologics license application (BLA) holders, and other interested parties regarding FDA’s interpretation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This guidance revises the draft guidance entitled ‘‘Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009,’’ issued February 15, 2012, to provide new and revised questions and answers (Q&As). DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 13, 2015. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002, or Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, SUMMARY: Food and Drug Administration AGENCY: Food and Drug Administration, HHS. PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 27321 MD 20993–0002. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Sandra Benton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD 20993–0002, 301– 796–1042, or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a revised draft guidance for industry entitled ‘‘Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.’’ This draft guidance provides answers to common questions from sponsors interested in developing proposed biosimilar products, BLA holders, and other interested parties regarding FDA’s interpretation of the BPCI Act. This guidance revises the draft guidance entitled ‘‘Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009,’’ issued February 15, 2012, to provide new and revised Q&As. It also includes certain original Q&As that have not yet been finalized. The BPCI Act, enacted as part of the Patient Protection and Affordable Care Act (Pub. L. 111–148) on March 23, 2010, created an abbreviated licensure pathway under section 351(k) of the Public Health Service Act (the PHS Act) (42 U.S.C. 262(k)) for biological products demonstrated to be biosimilar to, or interchangeable with, an FDAlicensed reference product. This draft guidance describes FDA’s current interpretation of certain statutory requirements added by the BPCI Act and includes Q&As in the following categories: • Biosimilarity or Interchangeability • Provisions Related to Requirement to Submit a BLA for a ‘‘Biological Product’’ E:\FR\FM\13MYN1.SGM 13MYN1

Agencies

[Federal Register Volume 80, Number 92 (Wednesday, May 13, 2015)]
[Notices]
[Page 27321]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11526]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0312]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Extra Label Drug Use in Animals

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, ``Extra Label Drug Use in Animals'' 
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 February 18, 2015, the Agency submitted a 
proposed collection of information entitled, ``Extra Label Drug Use in 
Animals'' 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 0910-0325. The approval 
expires on March 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: May 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-11526 Filed 5-12-15; 8:45 am]
 BILLING CODE 4164-01-P
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