[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access to the draft guidance recommendations.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:

C

Carbamazepine
Cholestyramine
Clindamycin HCl

D

Dinoprostone (multiple RLDs)

E

Enoxaparin
Ethinyl Estradiol Norethindrone
Etravirine

F

Fingolimod

I

Ibuprofen; Phenlyephrine HCl
Imiquimod

L

Lanthanum Carbonate
Loteprednol; Tobramycin

M

Methylphenidate HCl

P

Paliperidone Palmitate
Podofilox
Potassium Chloride (multiple RLDs)
Pyridostigmine Bromide

T

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:

A

Alendronate Sodium
Alendronate Sodium; Cholecalciferol

B

Benzoyl Peroxide; Erythromycin (multiple RLDs)

M

Milnacipran HCl
Mupirocin Calcium

N

Niacin; Simvastatin

S

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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