Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2009-N-0287]

# 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                           ( print 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