[Federal Register Volume 74, Number 224 (Monday, November 23, 2009)]
[Notices]
[Page 61151]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-28084]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0288]


Anthony W. Albanese: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) (the agency) is issuing 
an order under the Federal Food, Drug, and Cosmetic Act (the act) 
permanently debarring Anthony W. Albanese 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 Mr. Albanese was 
convicted of a felony under Federal law for conduct relating to the 
regulation of a drug product under the act. Mr. Albanese was given 
notice of the proposed permanent debarment and an opportunity to 
request a hearing within the time frame prescribed by regulation. As of 
October 30, 2009, Mr. Albanese has failed to respond. Mr. Albanese's 
failure to respond constitutes a waiver of his right to a hearing 
concerning this action.

DATES: This order is effective November 23, 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, Office of Regulatory 
Affairs (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 November 5, 2004, the U.S. District Court for the District of 
Rhode Island entered judgment against Mr. Albanese for one count of 
conspiracy to sell drug samples in violation of 18 U.S.C. 371; one 
count of unlawful sale of drug samples in violation of 21 U.S.C. 
331(t), 333(b)(1), and 353(c)(1); one count of health care fraud in 
violation of 18 U.S.C.1347(a) and 2; and one count of money laundering 
in violation of 18 U.S.C.1956(a)(1)(A)(i) and 2.
    FDA's finding that debarment is appropriate is based on the felony 
conviction related to the sale of drug samples. The factual basis for 
this conviction is as follows: From July 3, 2000, and continuing until 
on or about August 16, 2002, Mr. Albanese knowingly sold and offered to 
sell prescription drug samples that had been provided by pharmaceutical 
companies to Dr. Wallace E. Gonsalves, Jr. Mr. Albanese paid cash and 
goods in kind to Dr. Gonsalves for drug samples, removed the sample 
drugs from their packaging, and placed them for sale at his pharmacy as 
prescription drugs.
    As a result of his conviction, FDA sent Mr. Albanese by certified 
mail on September 1, 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 Mr. Albanese was 
convicted of a felony under Federal law for conduct relating to the 
regulation of a drug product under the act. The proposal also offered 
Mr. Albanese 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. Mr. Albanese failed to respond within the time frame prescribed 
by regulation 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 Mr. Albanese 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, Mr. Albanese is permanently 
debarred from providing services in any capacity to a person with an 
approved or pending drug product application under section 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), 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 Mr. Albanese, in any 
capacity, during Mr. Albanese's debarment, will be subject to civil 
money penalties (section 307(a)(6) of the act (21 U.S.C. 335b(a)(6)). 
If Mr. Albanese, 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 Mr. Albanese during his debarment (section 306(c)(1)(B) of the act).
    Any application by Mr. Albanese for special termination of 
debarment under section 306(d)(4) of the act should be identified with 
Docket No. FDA-2009-N-0288 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: November 10, 2009.
Brenda Holman,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. E9-28084 Filed 11-20-09; 8:45 am]
BILLING CODE 4160-01-S