Performance Review Board Members, 54051 [E9-25452]
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Federal Register / Vol. 74, No. 202 / Wednesday, October 21, 2009 / Notices
H1N1 as it relates to the mission of
NVAC. Representatives of state and
local health associations will also
provide their perspective.
For this special meeting, members of
the public are invited to attend by
teleconference via a toll-free call-in
phone number. The call-in number will
be operator assisted to provide members
of the public the opportunity to provide
comments to the Committee. Public
comment will be limited to no more
than three minutes per speaker. Preregistration is required for public
comment only. Individuals who plan to
attend and need special assistance, such
as accommodation for hearing
impairment or other reasonable
accommodations, should notify the
designated contact person at least one
week prior to the meeting.
Any members of the public who wish
to have printed material distributed to
NVAC should submit materials to the
Executive Secretary, NVAC, through the
contact person listed above prior to
close of business one week before the
meeting (conference call). A draft
agenda and any additional materials
will be posted on the NVAC Web site
(https://www.hhs.gov/nvpo/nvac/) prior
to the meeting.
Dated: October 15, 2009.
Bruce Gellin,
Deputy Assistant Secretary for Health,
Director, National Vaccine Program Office,
Executive Secretary, National Vaccine
Advisory Committee.
[FR Doc. E9–25366 Filed 10–20–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
jlentini on DSKJ8SOYB1PROD with NOTICES
Performance Review Board Members
Title 5, U.S.C. Section 4314(c)(4) of
the Civil Service Reform Act of 1978,
Public Law 95–454, requires notice of
appointment of individuals to serve as
a member of the Performance Review
Board shall be published in the Federal
Register.
The following individuals are hereby
appointed to serve on Performance
Review Boards within the Department
of Health and Human Services. These
individuals supplement membership on
existing Performance Review Boards.
Office of the Secretary
Moulds, Donald, Principal Deputy
Assistant Secretary.
Monahan, John, Director, Office of
Global Health Affairs.
VerDate Nov<24>2008
17:33 Oct 20, 2009
Jkt 220001
Centers for Disease Control and
Prevention
Branche, Christine, Associate Director
for NIOSH.
Health Resources and Services
Administration (HRSA)
Morford, Thomas G., Associate
Administrator, Office of Operations.
Indian Health Service (IHS)
Karol M.D., Susan, Chief Medical
Officer.
Dated: October 16, 2009.
Antonia T. Harris,
Deputy Assistant Secretary for Human
Resources, Department of Health and Human
Services.
[FR Doc. E9–25452 Filed 10–20–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0287]
Wallace E. Gonsalves, Jr., MD:
Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (the act) permanently
debarring Wallace E. Gonsalves, Jr., MD,
from providing services in any capacity
to a person that has an approved or
pending drug product application. We
base this order on a finding that Dr.
Gonsalves was convicted of a felony
under Federal law for conduct relating
to the regulation of a drug product
under the act. After being given notice
of the proposed permanent debarment
and an opportunity to request a hearing
within the timeframe prescribed by
regulation, Dr. Gonsalves failed to
request a hearing. Dr. Gonsalves’ failure
to request a hearing constitutes a waiver
of his right to a hearing concerning this
action.
DATES: This order is effective October
21, 2009.
ADDRESSES: Submit applications for
special 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:
Kenny Shade, Division of Compliance
Policy (HFC–230), Food and Drug
PO 00000
Frm 00034
Fmt 4703
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54051
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 240–632–6844.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(B) of the act (21
U.S.C. 335a(a)(2)(B)) requires debarment
of an individual if FDA finds that the
individual has been convicted of a
felony under Federal law for conduct
relating to the regulation of any drug
product under the act. On September
15, 2004, the U.S. District Court for the
District of Rhode Island entered
judgment against Dr. Gonsalves for two
counts of product tampering in violation
of 18 U.S.C. 1365(a) and two counts of
drug adulteration in violation of 21
U.S.C. 331(k) and 333(a)(2). On
September 14, 2004, the U.S. District
Court for the District of Rhode Island
accepted Dr. Gonsalves’ plea of guilty,
made under a plea agreement, and
entered judgment against Dr. Gonsalves
for one count of conspiracy to sell drug
samples in violation of 18 U.S.C. 371
and 21 U.S.C. 333(a)(2) and 353(c)(1),
one count of unlawful sale of drug
samples in violation of 21 U.S.C. 331(t),
333(b)(1), and 353(c)(1), and one count
of health care fraud in violation of 18
U.S.C. 1347(a) and 2.
FDA’s finding that debarment is
appropriate is based on two convictions
relating to adulteration of a drug (two
separate vaccines) and one conviction
relating to sale of drug samples. The
factual basis for those convictions is as
follows: From March of 2000 until on or
about August 26, 2002, with the intent
to defraud and mislead, Dr. Gonsalves
caused a quantity of Measles, Mumps,
and Rubella (MMR) and Varicella Virus
(varicella) vaccine to be adulterated
while the vaccine was being held for
sale and administered to patients after
being shipped in interstate commerce,
by reducing the quality and strength of
the vaccine and by failing to properly
store and maintain the vaccine, thereby
causing the vaccines to become
adulterated.
From July 3, 2000, and continuing
until at least on or about August 16,
2002, Dr. Gonsalves knowingly sold and
offered to sell quantities of drug samples
for cash or other consideration. As a
result of his convictions, FDA sent Dr.
Gonsalves by certified mail on August 7,
2009, a notice proposing to permanently
debar him from providing services in
any capacity to a person that has an
approved or pending drug product
application. The proposal was based on
a finding under section 306(a)(2)(B) of
the act that Dr. Gonsalves was convicted
of a felony under Federal law for
conduct relating to the regulation of a
drug product under the act. The
E:\FR\FM\21OCN1.SGM
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[Federal Register Volume 74, Number 202 (Wednesday, October 21, 2009)]
[Notices]
[Page 54051]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-25452]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Performance Review Board Members
Title 5, U.S.C. Section 4314(c)(4) of the Civil Service Reform Act
of 1978, Public Law 95-454, requires notice of appointment of
individuals to serve as a member of the Performance Review Board shall
be published in the Federal Register.
The following individuals are hereby appointed to serve on
Performance Review Boards within the Department of Health and Human
Services. These individuals supplement membership on existing
Performance Review Boards.
Office of the Secretary
Moulds, Donald, Principal Deputy Assistant Secretary.
Monahan, John, Director, Office of Global Health Affairs.
Centers for Disease Control and Prevention
Branche, Christine, Associate Director for NIOSH.
Health Resources and Services Administration (HRSA)
Morford, Thomas G., Associate Administrator, Office of Operations.
Indian Health Service (IHS)
Karol M.D., Susan, Chief Medical Officer.
Dated: October 16, 2009.
Antonia T. Harris,
Deputy Assistant Secretary for Human Resources, Department of Health
and Human Services.
[FR Doc. E9-25452 Filed 10-20-09; 8:45 am]
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