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Federal Register / Vol. 71, No.

200 / Tuesday, October 17, 2006 / Notices 61061

information to be collected; and (4) debarment and her opportunity to 1410.35), finds that Ms. Butkovitz has
ways to minimize the burden of the request a hearing within the timeframe been convicted of a felony under
collection of information on prescribed by regulation, Ms. Butkovitz Federal law for conduct relating to the
respondents, including through the use failed to request a hearing. Ms. development or approval, including the
of automated collection techniques Butkovitz’s failure to request a hearing process for development or approval, of
when appropriate, and other forms of constitutes a waiver of her right to a a drug product.
information technology. hearing concerning this action.
As a result of the foregoing finding,
The Older Americans Act (OAA) DATES: This order is effective October
requires annual program performance Ms. Butkovitz is permanently debarred
17, 2006.
reports from States. In compliance with from providing services in any capacity
ADDRESSES: Submit applications for to a person with an approved or
this OAA provision, AoA developed a termination of debarment to the
new State Program Report (SPR) in 1996 pending drug product application
Division of Dockets Management (HFA– (section 306(c)(1)(B) of the act). A drug
as part of its National Aging Program 305), Food and Drug Administration,
Information System (NAPIS). The SPR product means a drug, including a
5630 Fishers Lane, rm. 1061, Rockville,
collects information about how State biological product, subject to regulation
MD 20852.
Agencies on Aging expend their OAA under sections 505, 512, or 802 of the
funds as well as funding from other act (21 U.S.C. 355, 360b, or 382), or
Brenda R. Friend, Center for Biologics
sources for OAA authorized supportive under section 351 of the Public Health
Evaluation and Research (HFM–17),
services. The SPR also collects Service Act (42 U.S.C. 262). Any person
Food and Drug Administration, 1401
information on the demographic and Rockville Pike, Rockville, MD 20852– with an approved or pending drug
functional status of the recipients. This 1448, 301–827–6210. product application including, but not
collection was revised in November limited to, a biologics license
2004 (OMB Approval Number 0985– application, who knowingly employs or
0008). The proposed data collection I. Background retains as a consultant or contractor, or
continuation format remains unchanged On June 7, 2005, the U.S. District otherwise uses the services of Ms.
from the November 2004 document. It Court for the District of Massachusetts Butkovitz, in any capacity, during Ms.
may be found on the AoA Web site at accepted Ms. Anne L. Butkovitz’s plea Butkovitz’s permanent debarment, will of guilty to one count of making a false be subject to civil money penalties
NAPIS/docs/SPR-Modified-Form- statement, a Federal felony offense (section 307(a)(6) of the act (21 U.S.C.
11.08.04.pdf. AoA estimates the burden under 18 U.S.C. 1001. This offense was 335b(a)(6))). If Ms. Butkovitz, during her
of this collection of information as committed while Ms. Butkovitz was the permanent debarment, provides services
follows: 2,606 hours. clinical study coordinator at a safety site in any capacity to a person with an
Dated: October 12, 2006. for a clinical trial. approved or pending drug product
Josefina G. Carbonell, As a result of this conviction, FDA application including, but not limited
Assistant Secretary for Aging. served Ms. Butkovitz by certified mail to, a biologics license application, Ms.
[FR Doc. E6–17251 Filed 10–16–06; 8:45 am] on March 7, 2006, a notice proposing to Butkovitz will be subject to civil money
permanently debar Ms. Butkovitz from penalties (section 307(a)(7) of the act).
providing services in any capacity to a In addition, FDA will not accept or
person that has an approved or pending review any abbreviated new drug
DEPARTMENT OF HEALTH AND drug product application including, but applications submitted by or with the
HUMAN SERVICES not limited to, a biologics license
assistance of Ms. Butkovitz during Ms.
application. The proposal also offered
Butkovitz’s permanent debarment
Food and Drug Administration Ms. Butkovitz an opportunity for a
hearing on the proposal. The proposal (section 306(c)(1)(B) of the act).
[Docket No. 2006N–0018] Any application by Ms. Butkovitz for
was based on a finding, under section
Anne L. Butkovitz; Debarment Order 306(a)(2)(A) and (c)(2)(A)(ii) of the act termination of debarment under section
(21 U.S.C. 335a(a)(2)(A) and 306(d)(4) of the act should be identified
AGENCY: Food and Drug Administration, (c)(2)(A)(ii)), that Ms. Butkovitz was with Docket Number 2006N–0018 and
HHS. convicted of a felony under Federal law sent to the Division of Dockets
ACTION: Notice. for conduct relating to the development Management (see ADDRESSES). All such
or approval of a drug product, including submissions are to be filed in four
SUMMARY: The Food and Drug the process for development or copies (21 CFR 10.20(a)). The public
Administration (FDA) is issuing an approval, of a drug product. Ms. availability of information in these
order under the Federal Food, Drug, and Butkovitz was provided 30 days to file submissions is governed by 21 CFR
Cosmetic Act (the act) permanently objections and request a hearing. Ms. 10.20(j). Publicly available submissions
debarring Ms. Anne L. Butkovitz from Butkovitz did not request a hearing. Ms. may be seen in the Division of Dockets
providing services in any capacity to a Butkovitz’s failure to request a hearing Management between 9 a.m. and 4 p.m.,
person that has an approved or pending constitutes a waiver of her opportunity
drug product application including, but Monday through Friday (21 CFR
for a hearing and a waiver of any
not limited to, a biologics license 10.20(j)(1)).
contentions concerning her debarment
application. FDA bases this order on a (21 CFR 12.22(b)(1)). Dated: September 25, 2006.
finding that Ms. Butkovitz was Jesse Goodman,
convicted of a felony under Federal law II. Findings and Order
sroberts on PROD1PC70 with NOTICES

Director, Center for Biologics Evaluation and

for conduct relating to the development Therefore, the Director of the Center Research.
or approval, including the process for for Biologics Evaluation and Research, [FR Doc. E6–17178 Filed 10–16–06; 8:45 am]
development or approval, of a drug under section 306(a)(2)(A) of the act,
product under the act. After being given and under authority delegated to the
notice of the proposed permanent Director (FDA Staff Manual Guide

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