Draft Guidance for Industry on Bioequivalence Recommendations for Risperidone Injection; Availability, 52777 [2013-20696]

Download as PDF Federal Register / Vol. 78, No. 165 / Monday, August 26, 2013 / Notices II. Electronic Access Persons with access to the Internet may obtain the documents at either https://www.fda.gov/Drugs/Development ApprovalProcess/FormsSubmission Requirements/ElectronicSubmissions/ ucm253101.htm, https:// www.regulations.gov, or https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm. Dated: August 20, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–20697 Filed 8–23–13; 8:45 am] BILLING CODE 4160–01–P 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OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–D–0369] (Formerly Docket No. 2007D–0168) Draft Guidance for Industry on Bioequivalence Recommendations for Risperidone Injection; Availability AGENCY: Food and Drug Administration, HHS.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. The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled ‘‘Draft Guidance on Risperidone.’’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. SUMMARY: 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on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 25, 2013. DATES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201,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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written ehiers on DSK2VPTVN1PROD with NOTICES ADDRESSES: VerDate Mar<15>2010 13:45 Aug 23, 2013 Jkt 229001 52777 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: 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. I. Background II. Comments 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 productspecific bioequivalence (BE) recommendations available to the public on FDA’s Web site at https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ 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) LongActing 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). Interested persons may submit either written comments regarding this document to the Division of Dockets Management (see ADDRESSES) or electronic comments to https:// 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 https:// www.regulations.gov. PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 III. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. Dated: August 21, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–20696 Filed 8–23–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Implementation of the Revised International Guiding Principles for Biomedical Research Involving Animals The National Institutes of Health (NIH) is providing guidance to Public Health Service (PHS) awardee institutions on implementation of the revised International Guiding Principles for Biomedical Research Involving Animals (‘‘Guiding Principles’’). The NIH is seeking input from the public on any concerns they may have regarding the revised Guiding Principles. DATES: Public concerns regarding the revised Guiding Principles must be submitted electronically at https:// grants.nih.gov/grants/rfi/rfi.cfm?ID=35 by September 30, 2013 in order to be considered. SUMMARY: E:\FR\FM\26AUN1.SGM 26AUN1

Agencies

[Federal Register Volume 78, Number 165 (Monday, August 26, 2013)]
[Notices]
[Page 52777]
From the Federal Register Online via the Government Printing 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.

-----------------------------------------------------------------------

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 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: 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 https://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 https://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 https://www.regulations.gov.

III. Electronic Access

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

    Dated: August 21, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-20696 Filed 8-23-13; 8:45 am]
BILLING CODE 4160-01-P
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