[Federal Register Volume 78, Number 165 (Monday, August 26, 2013)]
[Notices]
[Page 52777]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-20696]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369] (Formerly Docket No. 2007D-0168)


Draft Guidance for Industry on Bioequivalence Recommendations for 
Risperidone Injection; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a revised draft guidance for industry entitled ``Draft 
Guidance on Risperidone.'' The guidance provides specific 
recommendations on the design of bioequivalence (BE) studies to support 
abbreviated new drug applications (ANDAs) for risperidone injection.

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 comments 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this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by October 25, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send 
one self-addressed 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Kris Andre, Center for Drug Evaluation 
and Research (HFD-600), Food and Drug Administration, 7519 Standish 
Pl., Rockville, MD 20855, 240-276-9326.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of May 31, 2007 (72 FR 30388), FDA 
announced the availability of a draft guidance for industry entitled 
``Bioequivalence Recommendations for Specific Products,'' which 
explained the process that would be used to make product-specific 
bioequivalence (BE) recommendations available to the public on FDA's 
Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. As 
described in that guidance, FDA adopted this process as a means to 
develop and disseminate product-specific BE recommendations and to 
provide a meaningful opportunity for the public to consider and comment 
on those recommendations. FDA finalized that guidance and announced its 
availability in the Federal Register of June 11, 2010 (75 FR 33311). 
This notice announces the availability of revised draft BE 
recommendations for risperidone injection.
    New drug application 021346 for Risperdal Consta (risperidone) 
Long-Acting Injection was initially approved by FDA in October 2003. In 
February 2010, FDA issued a draft guidance for industry on BE 
recommendations for generic risperidone injection (Draft BE 
Recommendations for Risperidone Injection). FDA is now issuing a 
revised version of the Draft BE Recommendations for Risperidone 
Injection (Revised Draft BE Recommendations).
    In February 2011, Johnson & Johnson Pharmaceutical Research and 
Development, L.L.C. submitted a citizen petition requesting that FDA 
require that any ANDA referencing Risperdal Consta (risperidone) Long-
Acting Injection meet certain requirements, including requirements 
related to demonstrating BE (Docket No. FDA-2011-P-0086). FDA is 
reviewing the issues raised in the petition. FDA will consider any 
comments on the Revised Draft BE Recommendations in responding to the 
citizen petition.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on the design 
of BE studies to support ANDAs for risperidone injection. It does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the requirements of the applicable statutes and 
regulations.

II. Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. It is only necessary 
to send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: August 21, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-20696 Filed 8-23-13; 8:45 am]
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