[Federal Register Volume 74, Number 202 (Wednesday, October 21, 2009)]
[Notices]
[Pages 54051-54052]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-25322]


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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.

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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 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

[[Page 54052]]

proposal also offered Dr. Gonsalves an opportunity to request a 
hearing, providing him 30 days from the date of receipt of the letter 
in which to file the request, and advised him that failure to request a 
hearing constituted a waiver of the opportunity for a hearing and of 
any contentions concerning this action. Dr. Gonsalves did not request a 
hearing and has, therefore, waived his opportunity for a hearing and 
waived any contentions concerning his debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Acting Director, Office of Enforcement, Office of 
Regulatory Affairs, under section 306(a)(2)(B) of the act and under 
authority delegated to the Acting Director (Staff Manual Guide 
1410.35), finds that Dr. Gonsalves has been convicted of a felony under 
Federal law for conduct relating to the regulation of a drug product 
under the act.
    As a result of the foregoing finding, Dr. Gonsalves is permanently 
debarred from providing services in any capacity to a person with an 
approved or pending drug product application under sections 505, 512, 
or 802 of the act (21 U.S.C. 355, 360b, or 382), or under section 351 
of the Public Health Service Act (42 U.S.C. 262), effective (see DATES) 
(see section 306(c)(1)(B) and (c)(2)(A)(ii) of the act and section 
201(dd) of the act (21 U.S.C. 321(dd)). Any person with an approved or 
pending drug product application who knowingly employs or retains as a 
consultant or contractor, or otherwise uses the services of Dr. 
Gonsalves, in any capacity, during Dr. Gonsalves' debarment, will be 
subject to civil money penalties (section 307(a)(6) of the act (21 
U.S.C. 335b(a)(6)). If Dr. Gonsalves, during his period of debarment, 
provides services in any capacity to a person with an approved or 
pending drug product application, he will be subject to civil money 
penalties (section 307(a)(7) of the act). In addition, FDA will not 
accept or review any abbreviated new drug applications submitted by or 
with the assistance of Dr. Gonsalves during his debarment (section 
306(c)(1)(B) of the act).
    Any application by Dr. Gonsalves for special termination of 
debarment under section 306(d)(4) of the act should be identified with 
Docket No. FDA-2009-N-0287 and sent to the Division of Dockets 
Management (see ADDRESSES). All such submissions are to be filed in 
four copies. The public availability of information in these 
submissions is governed by 21 CFR 10.20(j).
    Publicly available submissions may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: September 29, 2009.
Brenda Holman,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. E9-25322 Filed 10-20-09; 8:45 am]
BILLING CODE 4160-01-S