[Federal Register Volume 77, Number 35 (Wednesday, February 22, 2012)]
[Notices]
[Pages 10535-10536]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4037]
[[Page 10535]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-D-0369]
Final 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 final 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,
``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: Submit written or electronic comments on Agency guidances at any
time.
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 recommendations.
Submit electronic comments to http://www.regulations.gov. Submit
written comments on product-specific BE recommendations 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/CDER/GUIDANCE/bioequivalence/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, 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. Once finalized, the
recommendations are posted on FDA's Web site and announced in the
Federal Register. This notice announces final product-specific
recommendations that were posted on FDA's Web site in October 2011.
For a complete history of previous 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 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 Final Product-Specific BE Recommendations
are Available
FDA is announcing final product-specific BE recommendations for
drug products containing the following active ingredients:
A
Acetaminophen; Caffeine; Dihydrocodeine Bitartrate
C
Cephalexin
Ciprofloxacin
D
Desmopressin Acetate
E
Eletriptan HBr
F
Fenoprofen Calcium
Fludrocortisone Acetate
G
Glimepiride; Pioglitazone
H
Hydroxyzine Pamoate (multiple RLDs)
I
Imatinib Mesylate
L
Lansoprazole
Levetiracetam
Linezolid
M
Meprobamate
Methotrexate Sodium (multiple RLDs)
Methylprednisolone Acetate
Metoclopramide HCl
N
Nadolol
Nifedipine
Nilutamide
Nisoldipine
Nitazoxanide
Nitrofurantoin
Nitrofurantoin Macrocrystalline
O
Oxybutynin Chloride
P
Phendimetrazine Tartrate (multiple RLDs)
Phentermine HCl (multiple RLDs)
Phytonadione
Pregabalin
Propafenone HCl
Pyridostigmine Bromide
R
Raltegravir Potassium
Ramelteon
S
Scopolamine
Selegiline
Sorafenib Tosylate
T
Tamoxifen Citrate
Telbivudine
Temazepam
Terbinafine HCl
Toremifene Citrate
V
Voriconazole
Z
Zolpidem
III. 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
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guidance, notices, and received comments are available for public
examination in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA
through FDMS only at http://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/CDER/GUIDANCE/bioequivalence/default.htm or
http://www.regulations.gov.
Dated: February 14, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-4037 Filed 2-21-12; 8:45 am]
BILLING CODE 4160-01-P