FR DATE:10/17/2006

[Federal Register: October 17, 2006 (Volume 71, Number 200)]

[Notices]               
[Page 61061]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17oc06-111]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0018]

 
Anne L. Butkovitz; 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 Ms. Anne L. Butkovitz from providing services in any capacity 
to a person that has an approved or pending drug product application 
including, but not limited to, a biologics license application. FDA 
bases this order on a finding that Ms. Butkovitz was convicted of a 
felony under Federal law for conduct relating to the development or 
approval, including the process for development or approval, of a drug 
product under the act. After being given notice of the proposed 
permanent debarment and her opportunity to request a hearing within the 
timeframe prescribed by regulation, Ms. Butkovitz failed to request a 
hearing. Ms. Butkovitz's failure to request a hearing constitutes a 
waiver of her right to a hearing concerning this action.

DATES: This order is effective October 17, 2006.

ADDRESSES: Submit applications for 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: Brenda R. Friend, Center for Biologics 
Evaluation and Research (HFM-17), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    On June 7, 2005, the U.S. District Court for the District of 
Massachusetts accepted Ms. Anne L. Butkovitz's plea of guilty to one 
count of making a false statement, a Federal felony offense under 18 
U.S.C. 1001. This offense was committed while Ms. Butkovitz was the 
clinical study coordinator at a safety site for a clinical trial.
    As a result of this conviction, FDA served Ms. Butkovitz by 
certified mail on March 7, 2006, a notice proposing to permanently 
debar Ms. Butkovitz from providing services in any capacity to a person 
that has an approved or pending drug product application including, but 
not limited to, a biologics license application. The proposal also 
offered Ms. Butkovitz an opportunity for a hearing on the proposal. The 
proposal was based on a finding, under section 306(a)(2)(A) and 
(c)(2)(A)(ii) of the act (21 U.S.C. 335a(a)(2)(A) and (c)(2)(A)(ii)), 
that Ms. Butkovitz was convicted of a felony under Federal law for 
conduct relating to the development or approval of a drug product, 
including the process for development or approval, of a drug product. 
Ms. Butkovitz was provided 30 days to file objections and request a 
hearing. Ms. Butkovitz did not request a hearing. Ms. Butkovitz's 
failure to request a hearing constitutes a waiver of her opportunity 
for a hearing and a waiver of any contentions concerning her debarment 
(21 CFR 12.22(b)(1)).

II. Findings and Order

    Therefore, the Director of the Center for Biologics Evaluation and 
Research, under section 306(a)(2)(A) of the act, and under authority 
delegated to the Director (FDA Staff Manual Guide 1410.35), finds that 
Ms. Butkovitz has been convicted of a felony under Federal law for 
conduct relating to the development or approval, including the process 
for development or approval, of a drug product.
    As a result of the foregoing finding, Ms. Butkovitz is permanently 
debarred from providing services in any capacity to a person with an 
approved or pending drug product application (section 306(c)(1)(B) of 
the act). A drug product means a drug, including a biological product, 
subject to regulation 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). Any person with an approved or pending 
drug product application including, but not limited to, a biologics 
license application, who knowingly employs or retains as a consultant 
or contractor, or otherwise uses the services of Ms. Butkovitz, in any 
capacity, during Ms. Butkovitz's permanent debarment, will be subject 
to civil money penalties (section 307(a)(6) of the act (21 U.S.C. 
335b(a)(6))). If Ms. Butkovitz, during her permanent debarment, 
provides services in any capacity to a person with an approved or 
pending drug product application including, but not limited to, a 
biologics license application, Ms. Butkovitz 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 Ms. Butkovitz during Ms. Butkovitz's 
permanent debarment (section 306(c)(1)(B) of the act).
    Any application by Ms. Butkovitz for termination of debarment under 
section 306(d)(4) of the act should be identified with Docket Number 
2006N-0018 and sent to the Division of Dockets Management (see 
ADDRESSES). All such submissions are to be filed in four copies (21 CFR 
10.20(a)). 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 (21 CFR 10.20(j)(1)).

    Dated: September 25, 2006.
Jesse Goodman,
Director, Center for Biologics Evaluation and Research.
[FR Doc. E6-17178 Filed 10-16-06; 8:45 am]

BILLING CODE 4160-01-S