Science Board to the Food and Drug Administration; Request for Nominations SUBJECT>, 51830-51831 [E8-20574]
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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electronic access to the draft guidance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availability of a draft guidance for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described in that draft guidance, FDA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.
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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
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(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
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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).
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Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Notices
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FDA has special interest in ensuring
that women, minority groups, and
individuals with disabilities are
adequately represented on advisory
committees and, therefore, encourages
nominations qualified candidates from
these groups.
DATES: Nominations received on or
before October 6, 2008 will be given first
consideration for membership on the
Science Board. Nominations received
after October 6, 2008 will be considered
for nomination to the Science Board
should nominees still be needed.
ADDRESSES: All nomination for
membership should be sent
electronically to CV@OC.FDA.GOV, or
by mail to Advisory Committee
Oversight & Management Staff, 5600
Fishers Lane (HF–4), rm. 15A–12,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT:
Regarding all nomination questions for
membership, the primary contact is
˜
Carlos Pena, Office of Science and
Health Coordination, Office of the
Commissioner, Food and Drug
Administration (HF–33), 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
˜
6687, e-mail: carlos.Pena@fda.hhs.gov.
Information about becoming a member
on a FDA advisory committee can also
be obtained by visiting FDA’s Web site
by using the following link https://
www.fda.gov/oc/advisory/default.htm.
SUPPLEMENTARY INFORMATION: FDA is
requesting nominations to the Science
Board. The Science Board will meet
approximately four times a year.
Meetings of the Science Board will be
open to the public. All meetings will be
announced in the Federal Register at
least 15 days prior to each scheduled
public meeting.
I. General Function of the Committee
The Science Board shall provide
advice primarily to the Commissioner
and other appropriate officials on
specific complex and technical issues as
well as emerging issues within the
scientific community. Additionally, the
Science Board will provide advice to the
Agency on keeping pace with technical
and scientific evolutions in the fields of
regulatory science; on formulating an
appropriate research agenda; and on
upgrading its scientific and research
facilities to keep pace with these
changes. It will also provide the means
for critical review of Agency sponsored
intramural and extramural scientific
research programs.
II. Criteria for Members
Persons nominated for membership
shall be knowledgeable in the fields of
food safety, nutrition, chemistry,
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pharmacology, toxicology, clinical
research, or other scientific disciplines
such as systems biology, wireless
healthcare devices, nanotechnology,
medical imaging, robotics, cell and
tissue based products, regenerative
medicine, and combination products.
Members shall be chosen from academia
and industry. The Science Board may
include one technically qualified
member, selected by the Commissioner
or designee, who is identified with
consumer interests and is recommended
by either a consortium of consumeroriented organizations or other
interested persons. The Science Board
may also include technically qualified
Federal members.
III. Nomination Procedures
Any interested person may nominate
one or more qualified person for
membership on the Science Board. Self
nominations are also accepted.
Nominations shall include the name of
the committee, complete curriculum
vitae of each nominee, and their current
business address and telephone number
and e-mail address if available. Each
nomination shall state that the nominee
is aware of the nomination, is willing to
serve as a member, and appears to have
no conflict of interest that would
preclude membership. FDA will ask the
potential candidates to provide detailed
information concerning such matters as
financial holdings, employment, and
research grants and/or contracts to
permit evaluation of possible sources of
conflict of interest.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14
relating to advisory committees.
Dated: August 27, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–20574 Filed 9–4–08; 8:45 am]
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as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Center for
Complementary and Alternative Medicine,
Special Emphasis Panel, Exploratory Grants
for CAM Studies of Humans (R21).
Date: October 20–21, 2008.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road, NW.,
Washington, DC 20015.
Contact Person: Jeanette M. Hosseini, PhD,
Scientific Review Officer, Office of Scientific
Review, National Center for Complementary
and Alternative Medicine, NIH, 6707
Democracy Blvd., Suite 401, Bethesda, MD
20892, (301) 594–9096,
jeanettehmail.nih.gov.
Name of Committee: National Center for
Complementary and Alternative Medicine,
Special Emphasis Panel, Basic and
Preclinical Research on CAM.
Date: October 27–28, 2008.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Courtyard by Marriott Gaithersburg,
204 Boardwalk Place, Gaithersburg, MD
20878.
Contact Person: Peter Kozel, PhD,
Scientific Review Officer, NCCAM, 6707
Democracy Boulevard, Suite 401, Bethesda,
MD 20892–5475, 301–496–8004,
kozelpmail.nih.gov.
Dated: August 27, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–20626 Filed 9–4–08; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Federal Emergency Management
Agency
National Institutes of Health
Collection of Overpayments
National Center for Complementary &
Alternative Medicine; Notice of Closed
Meetings
AGENCY:
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
SUMMARY: This document provides
notice that the Federal Emergency
Management Agency (FEMA) has
terminated the current procedures for
the recoupment of overpayments of
disaster assistance made pursuant to
Section 408 of the Stafford Act, in
connection with Hurricanes Katrina and
Rita. Recoupment notices previously
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Federal Emergency
Management Agency, DHS.
ACTION: Notice.
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Agencies
[Federal Register Volume 73, Number 173 (Friday, September 5, 2008)]
[Notices]
[Pages 51830-51831]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-20574]
-----------------------------------------------------------------------
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
NominationsSUBJECT>
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).
[[Page 51831]]
FDA has special interest in ensuring that women, minority groups,
and individuals with disabilities are adequately represented on
advisory committees and, therefore, encourages nominations qualified
candidates from these groups.
DATES: Nominations received on or before October 6, 2008 will be given
first consideration for membership on the Science Board. Nominations
received after October 6, 2008 will be considered for nomination to the
Science Board should nominees still be needed.
ADDRESSES: All nomination for membership should be sent electronically
to CV@OC.FDA.GOV, or by mail to Advisory Committee Oversight &
Management Staff, 5600 Fishers Lane (HF-4), rm. 15A-12, Rockville, MD
20857.
FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions for
membership, the primary contact is Carlos Pe[ntilde]a, Office of
Science and Health Coordination, Office of the Commissioner, Food and
Drug Administration (HF-33), 5600 Fishers Lane, Rockville, MD 20857,
301-827-6687, e-mail: carlos.Pe[ntilde]a@fda.hhs.gov. Information about
becoming a member on a FDA advisory committee can also be obtained by
visiting FDA's Web site by using the following link https://www.fda.gov/
oc/advisory/default.htm.
SUPPLEMENTARY INFORMATION: FDA is requesting nominations to the Science
Board. The Science Board will meet approximately four times a year.
Meetings of the Science Board will be open to the public. All meetings
will be announced in the Federal Register at least 15 days prior to
each scheduled public meeting.
I. General Function of the Committee
The Science Board shall provide advice primarily to the
Commissioner and other appropriate officials on specific complex and
technical issues as well as emerging issues within the scientific
community. Additionally, the Science Board will provide advice to the
Agency on keeping pace with technical and scientific evolutions in the
fields of regulatory science; on formulating an appropriate research
agenda; and on upgrading its scientific and research facilities to keep
pace with these changes. It will also provide the means for critical
review of Agency sponsored intramural and extramural scientific
research programs.
II. Criteria for Members
Persons nominated for membership shall be knowledgeable in the
fields of food safety, nutrition, chemistry, pharmacology, toxicology,
clinical research, or other scientific disciplines such as systems
biology, wireless healthcare devices, nanotechnology, medical imaging,
robotics, cell and tissue based products, regenerative medicine, and
combination products. Members shall be chosen from academia and
industry. The Science Board may include one technically qualified
member, selected by the Commissioner or designee, who is identified
with consumer interests and is recommended by either a consortium of
consumer-oriented organizations or other interested persons. The
Science Board may also include technically qualified Federal members.
III. Nomination Procedures
Any interested person may nominate one or more qualified person for
membership on the Science Board. Self nominations are also accepted.
Nominations shall include the name of the committee, complete
curriculum vitae of each nominee, and their current business address
and telephone number and e-mail address if available. Each nomination
shall state that the nominee is aware of the nomination, is willing to
serve as a member, and appears to have no conflict of interest that
would preclude membership. FDA will ask the potential candidates to
provide detailed information concerning such matters as financial
holdings, employment, and research grants and/or contracts to permit
evaluation of possible sources of conflict of interest.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14 relating to advisory committees.
Dated: August 27, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-20574 Filed 9-4-08; 8:45 am]
BILLING CODE 4160-01-S