[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access to the draft guidance recommendations.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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