Publication of Guidances for Industry Describing Product-Specific Bioequivalence Recommendations, 51829-51830 [E8-20580]
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Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Notices
accepted by FDA only through FDMS at
https://www.regulations.gov.
Dated: August 22, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–20564 Filed 9–4–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0038]
Peripheral and Central Nervous
System Drugs Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on PROD1PC66 with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Peripheral and
Central Nervous System Drugs Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on October 23, 2008, from 8 a.m.
to 5 p.m.
Location: Hilton Washington DC/
Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD. The
hotel telephone number is 301–589–
5200.
Contact Person: Diem-Kieu Ngo,
Center for Drug Evaluation and Research
(HFD–21), Food and Drug
Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm.
1093), Rockville, MD 20857, 301–827–
7001, FAX: 301–827–6776, e-mail:
Diem.Ngo@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572) in the
Washington, DC area), code
3014512543. Please call the Information
Line for up-to-date information on this
meeting. A notice in the Federal
Register about last minute modifications
that impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the agency’s Web
site and call the appropriate advisory
committee hot line/phone line to learn
about possible modifications before
coming to the meeting.
VerDate Aug<31>2005
18:40 Sep 04, 2008
Jkt 214001
Agenda: The Committee will discuss
the clinical development of
radionuclide imaging products for the
detection of amyloid to assist in the
diagnosis of Alzheimer’s Disease.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/ohrms/
dockets/ac/acmenu.htm, click on the
year 2008 and scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before October 8, 2008.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those desiring to make
formal oral presentations should notify
the contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before September 30, 2008. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
October 1, 2008.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Diem-Kieu
Ngo at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/oc/advisory/
default.htm for procedures on public
conduct during advisory committee
meetings.
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Frm 00048
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51829
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: August 27, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–20577 Filed 9–4–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0369] (formerly
Docket No. 2007D–0168)
Publication of Guidances for Industry
Describing Product-Specific
Bioequivalence Recommendations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 productspecific guidance on the design of BE
studies to support abbreviated new drug
applications (ANDAs). In the Federal
Register of May 31, 2007 (72 FR 30388),
FDA announced the availability of a
draft guidance for industry,
‘‘Bioequivalence Recommendations for
Specific Products,’’ explaining 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 the draft product-specific
BE recommendations listed in this
notice by December 4, 2008.
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 selfaddressed adhesive label to assist that
office in processing your requests.
Submit written comments on the draft
product-specific BE recommendations
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov. See the
E:\FR\FM\05SEN1.SGM
05SEN1
51830
Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Notices
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
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–
276–9314.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of May 31,
2007 (72 FR 30388), FDA announced the
availability of a draft guidance for
industry, ‘‘Bioequivalence
Recommendations for Specific
Products,’’ that explained the process
that would be used to make productspecific BE recommendations available
to the public on FDA’s Web site at
https://www.fda.gov/CDER/GUIDANCE/
bioequivalence/default.htm. As
described in that draft guidance, FDA
adopted this process as a means to
develop and disseminate productspecific BE recommendations and
provide a meaningful opportunity for
the public to consider and comment on
those recommendations. Since that
notice was published we have
published a correction notice
concerning Bioequivalence
Recommendations for Specific Products
on October 25, 2007 (72 FR 60683). This
notice includes draft product-specific
recommendations either newly posted
or updated since the Federal Register
notice dated October 25, 2007, through
April 30, 2008.
mstockstill on PROD1PC66 with NOTICES
II. Drug Products for Which New Draft
Product-Specific BE Recommendations
Are Available
The following draft BE productspecific recommendations have been
newly posted since the FR notice dated
October 25, 2007:
(1) Abacavir Sulfate; Lamivudine
(2) Alendronate Sodium
(3) Alfuzosin HCl
(4) Alprazolam
(5) Amoxicillin; Clavulanate
Potassium (multiple RLDs)
(6) Amprenavir
(7) Aripiprazole
(8) Armodafinil
(9) Atovaquone
(10) Azithromycin
(11) Balsalazide Disodium
(12) Bupropion HCl (updated)
(13) Carbamazepine (multiple dosage
forms)
(14) Cefdinir
(15) Cefixime
(16) Cetirizine HCl; Pseudoephedrine
HCl
(17) Ciprofloxacin; Ciprofloxacin HCl
VerDate Aug<31>2005
18:40 Sep 04, 2008
Jkt 214001
(18) Ciprofloxacin HCl
(19) Clarithromycin
(20) Darunavir Ethanolate
(21) Delavirdine Mesylate
(22) Dexmethylphenidate
(23) Diltiazem HCl (multiple dosage
forms; multiple RLDs)
(24) Divalproex Sodium
(25) Doxycycline (multiple dosage
forms)
(26) Eprosartan Mesylate;
Hydrochlorothiazide
(27) Esterified Estrogens
(28) Eszopiclone
(29) Ethambutol HCl
(30) Ethinyl Estradiol; Levonorgestrel
(multiple RLDs)
(31) Fenofibrate
(32) Fluvastatin Sodium (multiple
dosage forms)
(33) Fosamprenavir Calcium
(34) Glimepiride; Rosiglitazone
Maleate
(35) Lamivudine
(36) Linezolid
(37) Lisinopril
(38) Lopinavir; Ritonavir
(39) Memantine HCl
(40) Mesalamine
(41) Metoprolol Succinate (updated)
(42) Minocycline HCl
(43) Nelfinavir Mesylate
(44) Nevirapine
(45) Omeprazole; Sodium
Bicarbonate; Magnesium Hydroxide
(46) Oxymorphone HCl (multiple
dosage forms)
(47) Paliperidone
(48) Paricalcitol
(49) Phenytoin
(50) Pimozide
(51) Posaconazole
(52) Quinine Sulfate
(53) Saquinavir Mesylate (multiple
dosage forms)
(54) Solifenacin Succinate
(55) Tenofovir Disoproxil Fumarate
(56) Tinidazole
(57) Tipranavir
(58) Tolterodine Tartrate
(59) Tramadol HCl
(60) Trospium Chloride
(61) Varenicline Tartrate
(62) Zafirlukast
(63) Zalcitabine
(64) Zileuton
(65) Zolmitriptan
(66) Zonisamide
III. Drug Products for Which Updated
Draft Product-Specific BE
Recommendations Are Available
The following five product-specific
recommendations previously made
available on FDA’s Web site have been
updated:
1. Risedronate Sodium
2. Fosinopril Sodium;
Hydrochlorothiazide
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
3. Fluoxetine HCl; Olanzapine
4. Erlotinib HCl
5. Morphine Sulfate
For a complete history of previous
Federal Register notices pertaining to
product-specific BE recommendations,
please go to https://www.regulations.gov
and enter FDA–2007–D–0369.
IV. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on any of the specific BE
recommendations posted on FDA’s Web
site. Two copies of mailed comments
are to be submitted, except that
individuals may submit one copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. The
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
https://www.regulations.gov.
V. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/cder/guidance/
index.htm or https://
www.regulations.gov.
Dated: August 27, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–20580 Filed 9–4–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0450]
Science Board to the Food and Drug
Administration; Request for
Nominations SUBJECT≤
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug Administration
(FDA) is requesting nominations to
serve on the Science Board to the FDA
(Science Board).
E:\FR\FM\05SEN1.SGM
05SEN1
Agencies
[Federal Register Volume 73, Number 173 (Friday, September 5, 2008)]
[Notices]
[Pages 51829-51830]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-20580]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-D-0369] (formerly Docket No. 2007D-0168)
Publication of Guidances for Industry Describing Product-Specific
Bioequivalence Recommendations
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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
May 31, 2007 (72 FR 30388), FDA announced the availability of a draft
guidance for industry, ``Bioequivalence Recommendations for Specific
Products,'' explaining 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 the draft product-
specific BE recommendations listed in this notice by December 4, 2008.
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. Submit written comments on the draft product-specific BE
recommendations to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852. Submit electronic comments to https://www.regulations.gov. See
the
[[Page 51830]]
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.
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, 240-276-9314.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of May 31, 2007 (72 FR 30388), FDA
announced the availability of a draft guidance for industry,
``Bioequivalence Recommendations for Specific Products,'' that
explained the process that would be used to make product-specific BE
recommendations available to the public on FDA's Web site at https://
www.fda.gov/CDER/GUIDANCE/bioequivalence/default.htm. As described in
that draft 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. Since that notice was published we have published a
correction notice concerning Bioequivalence Recommendations for
Specific Products on October 25, 2007 (72 FR 60683). This notice
includes draft product-specific recommendations either newly posted or
updated since the Federal Register notice dated October 25, 2007,
through April 30, 2008.
II. Drug Products for Which New Draft Product-Specific BE
Recommendations Are Available
The following draft BE product-specific recommendations have been
newly posted since the FR notice dated October 25, 2007:
(1) Abacavir Sulfate; Lamivudine
(2) Alendronate Sodium
(3) Alfuzosin HCl
(4) Alprazolam
(5) Amoxicillin; Clavulanate Potassium (multiple RLDs)
(6) Amprenavir
(7) Aripiprazole
(8) Armodafinil
(9) Atovaquone
(10) Azithromycin
(11) Balsalazide Disodium
(12) Bupropion HCl (updated)
(13) Carbamazepine (multiple dosage forms)
(14) Cefdinir
(15) Cefixime
(16) Cetirizine HCl; Pseudoephedrine HCl
(17) Ciprofloxacin; Ciprofloxacin HCl
(18) Ciprofloxacin HCl
(19) Clarithromycin
(20) Darunavir Ethanolate
(21) Delavirdine Mesylate
(22) Dexmethylphenidate
(23) Diltiazem HCl (multiple dosage forms; multiple RLDs)
(24) Divalproex Sodium
(25) Doxycycline (multiple dosage forms)
(26) Eprosartan Mesylate; Hydrochlorothiazide
(27) Esterified Estrogens
(28) Eszopiclone
(29) Ethambutol HCl
(30) Ethinyl Estradiol; Levonorgestrel (multiple RLDs)
(31) Fenofibrate
(32) Fluvastatin Sodium (multiple dosage forms)
(33) Fosamprenavir Calcium
(34) Glimepiride; Rosiglitazone Maleate
(35) Lamivudine
(36) Linezolid
(37) Lisinopril
(38) Lopinavir; Ritonavir
(39) Memantine HCl
(40) Mesalamine
(41) Metoprolol Succinate (updated)
(42) Minocycline HCl
(43) Nelfinavir Mesylate
(44) Nevirapine
(45) Omeprazole; Sodium Bicarbonate; Magnesium Hydroxide
(46) Oxymorphone HCl (multiple dosage forms)
(47) Paliperidone
(48) Paricalcitol
(49) Phenytoin
(50) Pimozide
(51) Posaconazole
(52) Quinine Sulfate
(53) Saquinavir Mesylate (multiple dosage forms)
(54) Solifenacin Succinate
(55) Tenofovir Disoproxil Fumarate
(56) Tinidazole
(57) Tipranavir
(58) Tolterodine Tartrate
(59) Tramadol HCl
(60) Trospium Chloride
(61) Varenicline Tartrate
(62) Zafirlukast
(63) Zalcitabine
(64) Zileuton
(65) Zolmitriptan
(66) Zonisamide
III. Drug Products for Which Updated Draft Product-Specific BE
Recommendations Are Available
The following five product-specific recommendations previously made
available on FDA's Web site have been updated:
1. Risedronate Sodium
2. Fosinopril Sodium; Hydrochlorothiazide
3. Fluoxetine HCl; Olanzapine
4. Erlotinib HCl
5. Morphine Sulfate
For a complete history of previous Federal Register notices pertaining
to product-specific BE recommendations, please go to https://
www.regulations.gov and enter FDA-2007-D-0369.
IV. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on any of the specific
BE recommendations posted on FDA's Web site. Two copies of mailed
comments are to be submitted, except that individuals may submit one
copy. Comments are to be identified with the docket number found in
brackets in the heading of this document. The 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 https://www.regulations.gov.
V. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/cder/guidance/index.htm or https://
www.regulations.gov.
Dated: August 27, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-20580 Filed 9-4-08; 8:45 am]
BILLING CODE 4160-01-S