[Federal Register Volume 79, Number 215 (Thursday, November 6, 2014)]
[Notices]
[Pages 65978-65979]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-26306]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369, formerly 2007D-0168]


Bioequivalence Recommendations for CONCERTA (Methylphenidate 
Hydrochloride) Extended-Release Tablets; Draft Guidance for Industry; 
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availability of a draft guidance for industry entitled ``Bioequivalence 
Recommendations for CONCERTA (methylphenidate hydrochloride) Extended-
Release Tablets.'' The recommendations provide specific guidance on the 
design of bioequivalence (BE) studies to support abbreviated new drug 
applications (ANDAs) that reference the listed drug CONCERTA 
(methylphenidate hydrochloride (HCl)) extended-release tablets (new 
drug application (NDA) 021121). The draft guidance is a revised version 
of a previously issued draft guidance on the same subject.

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this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by January 5, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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. 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section for electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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 Andr[eacute], Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 4726, Silver Spring, MD 20993-0002, 240-
402-7959.

[[Page 65979]]


SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA 
announced the availability of a guidance for industry, ``Bioequivalence 
Recommendations for Specific Products,'' which explained the process 
that would be used to make product-specific 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 provide 
a meaningful opportunity for the public to consider and comment on 
those recommendations. This notice announces the availability of draft 
BE recommendations for CONCERTA (methylphenidate HCl) extended-release 
tablets. This draft guidance revises and replaces the draft guidance 
for industry entitled ``Draft and Revised Draft Guidances for Industry 
Describing Product-Specific Bioequivalence Recommendations; 
Availability,'' issued on September 14, 2012 (77 FR 56851), which 
provided recommendations to establish BE to CONCERTA (methylphenidate 
hydrochloride) (NDA 021121).
    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 CONCERTA (methylphenidate HCl) 
extended-release tablets. 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 electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). 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: October 31, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-26306 Filed 11-5-14; 8:45 am]
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