Center For Scientific Review; Notice of Closed Meetings, 11991 [2015-05005]
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Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center For Scientific Review; Notice of
Closed Meetings
mstockstill on DSK4VPTVN1PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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.,
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: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Neurobiology of Addictions.
Date: March 11, 2015.
Time: 11:30 a.m. to 12:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Boris P. Sokolov, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5217A,
MSC 7846, Bethesda, MD 20892, 301–408–
9115, bsokolov@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Neurobiology of Psychiatric
Disorders.
Date: March 11, 2015.
Time: 12:30 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Boris P. Sokolov, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5217A,
MSC 7846, Bethesda, MD 20892, 301–408–
9115, bsokolov@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflicts and Continuous Submissions.
Date: March 25, 2015.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
VerDate Sep<11>2014
19:28 Mar 04, 2015
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Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Olga A. Tjurmina, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4138,
MSC 7814, Bethesda, MD 20892, (301) 451–
1375, ot3d@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR–13–
009: Secondary Dataset Analyses in Heart,
Lung, and Blood Diseases and Sleep
Disorders.
Date: March 26, 2015.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Melrose Georgetown Hotel, 2430
Pennsylvania Avenue NW., Washington, DC
20037.
Contact Person: George Vogler, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3140,
MSC 7770, Bethesda, MD 20892, (301) 237–
2693, voglergp@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846-93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: February 25, 2015.
Carolyn Baum,
Program Analyst. Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–05005 Filed 3–4–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0302]
Jeffrey L. Rockmore; Denial of
Hearing; Final Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is denying a
request for a hearing submitted by Dr.
Jeffrey L. Rockmore, and is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) debarring Dr.
Rockmore for 2 years from providing
services in any capacity to a person that
has an approved or pending drug
product application. FDA bases this
order on a finding that Dr. Rockmore
was convicted of a misdemeanor under
Federal law for conduct relating to the
regulation of a drug product under the
FD&C Act and that the type of conduct
underlying the conviction undermines
the process for the regulation of drugs.
SUMMARY:
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Fmt 4703
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11991
In determining the appropriateness and
period of Dr. Rockmore’s debarment,
FDA has considered the relevant factors
listed in the FD&C Act. Dr. Rockmore
has failed to file with the Agency
information and analyses sufficient to
create a basis for a hearing concerning
this action.
DATES: The order is effective March 5,
2015.
ADDRESSES: Submit applications for
termination of debarment to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Nathan Doty, Office of Scientific
Integrity, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 301–
796–8556.
SUPPLEMENTARY INFORMATION:
I. Background
On August 11, 2009, in the U.S.
District Court for the Northern District
of New York, Dr. Rockmore, a
physician, pled guilty to a misdemeanor
under the FD&C Act, namely
misbranding a drug in violation of
sections 301(k), 502(i)(3) and 303(a)(1)
of the FD&C Act (21 U.S.C. 331(k),
352(i)(3), 333(a)(1)) and 18 U.S.C. 2. The
basis for this conviction was conduct
surrounding his injection of patients
seeking treatment with BOTOX/BOTOX
Cosmetic (BOTOX) with a product, TRItoxin, distributed by Toxin Research
International, Inc. BOTOX is a
biological product derived from
Botulinum Toxin Type A that is
manufactured by Allergan, Inc., and was
approved by FDA for use on humans for
the treatment of facial wrinkles in 1991.
According to the records of the criminal
proceedings, Dr. Rockmore’s colleague
in the same medical practice, The
Plastic Surgery Group (TPSG), directed
a nurse to obtain 31 vials of TRI-toxin,
an unapproved drug product, which
was represented by its distributor as
‘‘Botulinum Toxin Type A’’. Dr.
Rockmore then proceeded to inject
approximately 26 patients, who
believed they were being injected with
BOTOX, with TRI-toxin as a substitute.
Dr. Rockmore is subject to debarment
based on a finding, under section
306(b)(2)(B)(i)(I) of the FD&C Act (21
U.S.C. 335a(b)(2)(B)(i)(I)): (1) That he
was convicted of a misdemeanor under
Federal law relating to the regulation of
a drug product under the FD&C Act and
(2) that the type of conduct underlying
the conviction undermines the process
for the regulation of drugs. By notice to
Dr. Rockmore dated November 30, 2010,
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05MRN1
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[Federal Register Volume 80, Number 43 (Thursday, March 5, 2015)]
[Notices]
[Page 11991]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-05005]
[[Page 11991]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center For Scientific Review; Notice of Closed Meetings
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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., 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: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Neurobiology of Addictions.
Date: March 11, 2015.
Time: 11:30 a.m. to 12:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Boris P. Sokolov, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5217A, MSC 7846, Bethesda, MD
20892, 301-408-9115, bsokolov@csr.nih.gov.
This notice is being published less than 15 days prior to the
meeting due to the timing limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Neurobiology of Psychiatric Disorders.
Date: March 11, 2015.
Time: 12:30 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Boris P. Sokolov, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5217A, MSC 7846, Bethesda, MD
20892, 301-408-9115, bsokolov@csr.nih.gov.
This notice is being published less than 15 days prior to the
meeting due to the timing limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflicts and Continuous Submissions.
Date: March 25, 2015.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Olga A. Tjurmina, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4138, MSC 7814, Bethesda, MD
20892, (301) 451-1375, ot3d@nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; PAR-13-009: Secondary Dataset Analyses in Heart, Lung, and
Blood Diseases and Sleep Disorders.
Date: March 26, 2015.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Melrose Georgetown Hotel, 2430 Pennsylvania Avenue NW.,
Washington, DC 20037.
Contact Person: George Vogler, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 3140, MSC 7770, Bethesda, MD 20892, (301) 237-
2693, voglergp@csr.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.306,
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893,
National Institutes of Health, HHS)
Dated: February 25, 2015.
Carolyn Baum,
Program Analyst. Office of Federal Advisory Committee Policy.
[FR Doc. 2015-05005 Filed 3-4-15; 8:45 am]
BILLING CODE 4140-01-P
