[Federal Register Volume 77, Number 56 (Thursday, March 22, 2012)]
[Notices]
[Pages 16842-16843]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-6947]


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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 May 21, 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access to the draft guidance recommendations.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 (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 of January 25,

[[Page 16843]]

2012 (77 FR 3777). 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:

A
Acyclovir (multiple reference listed drugs (RLDs),
Amiloride,
B
Butenafine HCl (multiple RLDs),Chlorpromazine HCl,
C
Clindamycin Phosphate (multiple RLDs),
D
Dalfampridine,
Dexmethylphenidate HCl,
Dextromethorphan HBr; Quinidine Sulfate,
Diclofenac Epolamine,
Drospirenone Ethinyl Estradiol; Levomefolate,
E
Ethinyl Estradiol; Norethindrone,
F
Fenofibrate,
Fludarabine,
Fulvestrant,
G
Glyburide (multiple RLDs),
Granisetron,
I
Ivermectin,
K
Ketoconazole (multiple RLDs),
M
Memantine HCl,
Metformin Hydrochloride; Saxagliptin,
N
Naftifine HCl (multiple RLDs),
Nitrofurantoin; Nitrofurantoin Macrocrystalline,
O
Ondansetron,
Oxiconazole Nitrate (multiple RLDs),
P
Pimecrolimus,
Procarbazine,
Propylthiouracil,
S
Sumatriptan,
T
Tacrolimus (multiple strengths),
Tolvaptan,
Tretinoin (multiple RLDs),
V
Vardenafil HCl,

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:

B
Benzoyl Peroxide; Clindamycin Phosphate (multiple RLDs),
Bosentan,
C
Cholestyramine,
Colesevelam,
D
Dexamethasone; Tobramycin (multiple RLDs),
H
Hydrochlorothiazide; Irbesartan,
L
Loteprednol,
Loteprednol; Tobramycin,
P
Paliperidone

    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.

IV. 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. It is no longer necessary to 
send two copies of mailed 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.

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: March 16, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-6947 Filed 3-21-12; 8:45 am]
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