[Federal Register Volume 78, Number 215 (Wednesday, November 6, 2013)]
[Notices]
[Pages 66745-66746]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-26546]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-D-0369]
Draft and Revised Draft Guidances for Industry Describing
Product-Specific Bioequivalence Recommendations; 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 additional draft and revised draft product-specific
bioequivalence (BE) recommendations. The recommendations provide
product-specific guidance on the design of BE studies to support
abbreviated new drug applications (ANDAs). In the Federal Register of
June 11, 2010, FDA announced the availability of a guidance for
industry entitled ``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. The BE recommendations identified in this notice were
developed using the process described in that guidance.
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
these draft and revised draft guidances before it begins work on the
final versions of the guidances, submit either electronic or written
comments on the draft and revised draft product-specific BE
recommendations listed in this notice by January 6, 2014.
ADDRESSES: Submit written requests for single copies of the individual
BE guidances 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access to the draft guidance recommendations.
Submit electronic comments on the draft product-specific BE
recommendations 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 (HFD-600), Food and Drug Administration, 7520
Standish Pl., Rockville, MD 20855, 240-276-8866.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``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. Under that process, draft
recommendations are posted on FDA's Web site and announced periodically
in the Federal Register. The public is encouraged to submit comments on
those recommendations within 60 days of their announcement in the
Federal Register. FDA considers any comments received and either
publishes final recommendations or publishes revised draft
recommendations for comment. Recommendations were last announced in the
Federal Register on June 20, 2013 (78 FR 37230). This notice announces
draft product-specific recommendations, either new or revised, that are
being posted on FDA's Web site concurrently with publication of this
notice.
II. Drug Products for Which New Draft Product-Specific BE
Recommendations Are Available
FDA is announcing new draft product-specific BE recommendations for
drug products containing the following active ingredients:
Table 1--New Draft Product-Specific BE Recommendations for Drug Products
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B................................. Bedaquiline fumarate.
Bupropion hydrochloride.
C................................. Clobazam.
E................................. Etodolac (multiple reference listed
drugs and dosage forms).
M................................. Mesna.
Methenamine hippurate.
Methocarbamol.
N................................. Nicotine (multiple reference listed
drugs).
Nicotine polacrilex (multiple
reference listed drugs).
P................................. Phentermine hydrochloride.
Prednisone.
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III. Drug Products for Which Revised Draft Product-Specific BE
Recommendations Are Available
FDA is announcing revised draft product-specific BE recommendations
for drug products containing the following active ingredients:
Table 2--Revised Draft Product-Specific BE Recommendations for Drug
Products
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A................................. Acitretin.
Amphetamine aspartate; Amphetamine
sulfate; Dextroamphetamine
saccharate; Dextroamphetamine
sulfate.
B................................. Bumetanide.
Bupropion hydrobromide.
Bupropion hydrochloride (multiple
reference listed drugs and dosage
forms).
C................................. Cefixime.
Celecoxib.
Colesevelam hydrochloride.
D................................. Doxorubicin hydrochloride.
Drospirenone; Ethinyl estradiol.
L................................. Lanthanum carbonate.
Lenalidomide.
O................................. Oxybutynin chloride.
R................................. Rivastigmine.
T................................. Tacrolimus (multiple strengths).
Testosterone (multiple reference
listed drugs and dosage forms).
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For a complete history of previously published Federal Register
notices related to product-specific BE recommendations, please go to
http://www.regulations.gov and enter Docket No. FDA-2007-D-0369.
These draft and revised draft guidances are being issued consistent
with FDA's good guidance practices regulation (21 CFR 10.115). These
guidances represent the Agency's current thinking on product-specific
design of BE studies to support ANDAs. They do not create or confer any
rights for or on any person and do 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.
[[Page 66746]]
IV. Comments
Interested persons may submit either electronic comments on any of
the specific BE recommendations posted on FDA's Web site 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. The guidances, notices, and 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.
V. 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, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-26546 Filed 11-5-13; 8:45 am]
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