[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]
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