Federal Register / Vol. 74, No. 202 / Wednesday, October 21, 2009 / Notices 54051 

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 

(http://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] 

BILLING CODE 4150–44–P 

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] 

BILLING CODE P 

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 

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 


jlentini on DSKJ8SOYB1PROD with NOTICES
54052 Federal Register / Vol. 74, No. 202 / Wednesday, October 21, 2009 / Notices 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0508] 

Draft Guidance for Industry on 

Registration and Product Listing for 

Owners and Operators of Domestic 

Tobacco Product Establishments; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Registration and 

Product Listing for Owners and 

Operators of Domestic Tobacco Product 

Establishments.’’ The draft guidance 

document is intended to assist persons 

making tobacco product establishment 

registration and product listing 

submissions to FDA under The Family 

Smoking Prevention and Tobacco 

Control Act (FSPTCA). 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by October 30, 2009. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document entitled ‘‘Registration and 

Product Listing for Owners and 

Operators of Domestic Tobacco Product 

Establishments’’ to the Center for 

Tobacco Products, Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850–3229. Send one 

self-addressed adhesive label to assist 

that office in processing your request or 

include a fax number to which the draft 

guidance document may be sent. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

Submit written comments on the 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Michele Mital, Center for Tobacco 

Products, Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850–3229, 301–796– 

4800, Michele.Mital@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On June 22, 2009, the President 

signed the FSPTCA (Public Law 111–31) 

into law. The FSPTCA amended the 

Federal Food, Drug, and Cosmetic Act 

(the act) (21 U.S.C. 301 et seq.) by, 

among other things, adding a new 

chapter granting FDA important new 

authority to regulate the manufacture, 

marketing, and distribution of tobacco 

products to protect the public health 

generally and to reduce tobacco use by 

minors. 

Section 905(b) of the act (21 U.S.C. 

395(b)), as amended by the FSPTCA, 

requires that ‘‘every person who owns 

or operates any establishment in any 

State engaged in the manufacture, 

preparation, compounding, or 

processing of a tobacco product or 

tobacco products’’ register with FDA the 

name, places of business, and all 

establishments owned or operated by 

that person. Every person must register 

by December 31 of each year. Section 

905(i)(1) of the act, as amended by the 

FSPTCA, requires that all registrants 

‘‘shall, at the time of registration under 

any such subsection, file with [FDA] a 

list of all tobacco products which are 

being manufactured, prepared, 

compounded, or processed by that 

person for commercial distribution,’’ 

along with certain accompanying 

consumer information, such as all 

labeling and a representative sampling 

of advertisements. 

While electronic submission of 

registration and listing information is 

not required, FDA is strongly 

encouraging electronic submission to 

facilitate efficiency and timeliness of 

data management and collection. To 

that end, FDA designed the eSubmitter 

application to streamline the data entry 

process for registration and product 

listing. This tool allows for importation 

of large quantities of structured data, 

attachments of files (e.g., in portable 

document format (PDFs) and certain 

media files), and automatic 

acknowledgement of FDA’s receipt of 

submissions. 


jlentini on DSKJ8SOYB1PROD with NOTICES