Federal Register, Volume 77 Issue 35 (Wednesday, February 22, 2012)

[Federal Register Volume 77, Number 35 (Wednesday, February 22, 2012)]
[Notices]
[Pages 10536-10537]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4035]

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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 (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. The BE recommendations identified in this document 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 April 23, 2012.

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access to the draft guidance recommendations.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: Doan T. Nguyen, Center for Drug
Evaluation and Research (HFD-600), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-276-8608.

SUPPLEMENTARY INFORMATION:

I. Background

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 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 the 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 of
January 25, 2012 (77 FR 3777). This notice announces draft product-
specific recommendations, either new or revised, that have been posted
on the FDA's Web site in the period from July 1, 2011, through November
30, 2011.
For a complete history of previously published Federal Register
notices relating to product-specific BE recommendations, please go to
http://www.regulations.gov and enter docket number 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). The
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.

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:

Carbamazepine
Cholestyramine
Clindamycin HCl

Dinoprostone (multiple RLDs)

Enoxaparin
Ethinyl Estradiol Norethindrone
Etravirine

Fingolimod

Ibuprofen; Phenlyephrine HCl
Imiquimod

Lanthanum Carbonate
Loteprednol; Tobramycin

Methylphenidate HCl

Paliperidone Palmitate
Podofilox
Potassium Chloride (multiple RLDs)
Pyridostigmine Bromide

Testosterone

[[Page 10537]]

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:

Alendronate Sodium
Alendronate Sodium; Cholecalciferol

Benzoyl Peroxide; Erythromycin (multiple RLDs)

Milnacipran HCl
Mupirocin Calcium

Niacin; Simvastatin

Sevelamer HCl

IV. Drug Products for Which Draft Product-Specific BE Recommendations
Have Been Withdrawn

FDA is announcing the withdrawal of the product-specific BE
recommendations for drug products containing the following ingredients:
Acetaminophen; Propoxyphene Napsylate. FDA has requested that products
containing propoxyphene be withdrawn from sale for reasons of safety or
efficacy. The product-specific BE recommendations for Acetaminophen;
Propoxyphene Napsylate that previously were published on the
``Bioequivalence Recommendations for Specific Products'' Web page have
been deleted.

V. Comments

Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments on any of the
specific BE recommendations posted on FDA's Web site. 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
guidance, notices, and received comments may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

VI. 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: February 14, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-4035 Filed 2-21-12; 8:45 am]
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