[Federal Register Volume 79, Number 63 (Wednesday, April 2, 2014)]
[Notices]
[Pages 18561-18562]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-07330]
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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 ``Guidance for Industry on Bioequivalence
Recommendations for Specific Products; Availability,'' 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 June 2, 2014.
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access to the draft guidance recommendations.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: Kris Andr[eacute], Center for Drug
Evaluation and Research (HFD-600), Food and Drug Administration, 7520
Standish Pl., Rockville, MD 20855, 240-276-8866.
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
``Guidance for Industry on Bioequivalence Recommendations for Specific
Products; Availability,'' 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
[[Page 18562]]
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 on November 6, 2013 (78 FR
66745). This notice announces draft product-specific recommendations,
either new or revised, that are posted on FDA's Web site.
II. Drug Products for Which New Draft Product-Specific BE
Recommendations Are Available
FDA is announcing the availability of a new draft guidance for
industry on product-specific BE recommendations for drug products
containing the following active ingredients:
Table 1--New Draft Product-Specific BE Recommendations for Drug Products
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A.............................. Amphotericin B.
Atorvastatin calcium; Ezetimibe.
Axitinib.
B.............................. Brinzolamide.
Buprenorphine.
Buprenorphine hydrochloride.
Buprenorphine hydrochloride; Naloxone
hydrochloride.
C.............................. Clobazam.
D.............................. Desoximetasone (multiple reference
listed drugs and dosage forms).
Diazoxide.
E.............................. Erythromycin.
Estradiol.
F.............................. Fentanyl citrate.
G.............................. Guaifenesin.
H.............................. Hydrochlorothiazide; Metoprolol
succinate.
L.............................. Levonorgestrel (multiple reference
listed drugs).
Linagliptin; Metformin hydrochloride.
M.............................. Mesalamine.
P.............................. Perampanel.
Pindolol.
Prednisolone acetate.
R.............................. Rabeprazole sodium.
T.............................. Teriflunomide.
Tranylcypromine sulfate.
V.............................. Verteporfin.
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III. Drug Products for Which Revised Draft Product-Specific BE
Recommendations Are Available
FDA is announcing the availability of a revised draft guidance for
industry on product-specific BE recommendations for drug products
containing the following active ingredients:
Table 2--Revised Draft Product-Specific BE Recommendations for Drug
Products
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A.............................. Abiraterone acetate.
Amlodipine besylate; Benazepril
hydrochloride.
B.............................. Brimonidine tartrate (multiple
reference listed drugs).
D.............................. Doxycycline hyclate.
Dronabinol.
Dutasteride; Tamsulosin hydrochloride.
I.............................. Icosapent Ethyl.
L.............................. Leuprolide acetate (multiple reference
listed drugs and strengths).
M.............................. Metoprolol succinate.
Morphine sulfate.
Mycophenolate mofetil (multiple
reference listed drugs and dosage
forms).
Mycophenolic acid.
N.............................. Naltrexone.
O.............................. Octreotide acetate.
T.............................. Trimethoprim.
Triptorelin pamoate
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For a complete history of previously published Federal Register
notices related to product-specific BE recommendations, please go to
http://www.regulations.gov and enter Docket No. 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). These
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 either electronic comments on any of
the specific BE recommendations posted on FDA's Web site to http://www.regulations.gov or written comments to the Division of Dockets
Management (see ADDRESSES). It is only necessaary to send one set of
comments. Identify comments with the docket number found in brackets in
the heading of this document. The guidances, notices, and received
comments may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday, and will be posted to the
docket at http://www.regulations.gov.
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 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07330 Filed 4-1-14; 8:45 am]
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