Federal Register / Vol. 72, No. 19 / Tuesday, January 30, 2007 / Notices 4269
TABLE 1. ESTIMATED ANNUAL REPORTING BURDEN 1
FDA Form No. of Annual Frequency Total Annual Hours per
21 CFR Section Total Hours
Number Respondents per Response Responses Responses
600.14 3486 147 2.73 401 2.0 802
606.171 2 3486 194 169.89 32,958 2.0 65,916
606.171 3 3486 6,210 1.50 9,311 2.0 18,622
3486A 4 6,551 0.33 2,133 0.5 1,067
1 There are no capital costs or maintenance costs associated with this collection of information.
2 Licensed manufacturers of human blood and blood components, including Source Plasma.
3 Unlicensed registered blood establishments and transfusion services (1,230 + 4,980 = 6,210).
4 Five percent of the total annual responses to CBER (42,653 x 0.05 = 2,133).
Dated: January 24, 2007. Lane, Rockville, MD 20857, 301–594– product application. The notice also
Jeffrey Shuren, 2041. offered Mr. Kimball an opportunity to
Assistant Commissioner for Policy. SUPPLEMENTARY INFORMATION: request a hearing on the debarment
[FR Doc. E7–1415 Filed 1–29–07; 8:45 am] proposal. The debarment proposal was
I. Background based on a finding, under section
BILLING CODE 4160–01–S
On May 24, 2000, a jury found Mr. 306(a)(2)(B) of the act (21 U.S.C.
Kimball guilty of one count of 335a(a)(2)(B)), that Mr. Kimball was
DEPARTMENT OF HEALTH AND conspiring to commit offenses against convicted of felonies under Federal law
HUMAN SERVICES the United States and the Florida for conduct relating to the regulation of
Department of Health, a Federal felony a drug product under the act.
Food and Drug Administration offense under 18 U.S.C. 371; six counts The certified letter also informed Mr.
[Docket No. 2005N–0105] of distributing a misbranded drug into Kimball that his request for a hearing
interstate commerce, a Federal felony could not rest upon mere allegations or
James T. Kimball; Denial of Hearing; offense under 21 U.S.C. 331(a); and one denials, but must present specific facts
Final Debarment Order count of making a false statement in a showing that there was a genuine and
matter within the jurisdiction of a substantial issue of fact requiring a
AGENCY: Food and Drug Administration, Federal agency, a Federal felony offense hearing. The letter also informed Mr.
HHS. under 18 U.S.C. 1001. On October 19, Kimball that the only material issue of
ACTION: Notice. 2000, the U.S. District Court for the fact was whether he was convicted as
Middle District of Florida entered alleged in the letter, and that the facts
SUMMARY: The Food and Drug judgment and sentenced Mr. Kimball for underlying his conviction are not at
Administration (FDA) is denying Mr. these offenses. issue in this proceeding. Finally, the
James T. Kimball’s request for a hearing The bases for these convictions were letter informed Mr. Kimball that if it
and is issuing a final order under the Mr. Kimball’s knowing and willful conclusively appeared from the face of
Federal Food, Drug, and Cosmetic Act participation, including conspiring, to the information and factual analyses in
(the act) permanently debarring Mr. violate Federal laws in connection with his request for a hearing that there was
James T. Kimball from providing the distribution of a misbranded drug, no genuine and substantial issue of fact
services in any capacity to a person that deprenyl, into interstate commerce, and that precluded the order of debarment,
has an approved or pending drug false statements he made to the U.S. FDA would enter summary judgment
product application. FDA bases this Customs Service about shipments of against him and deny his request for a
order on a finding that Mr. Kimball was deprenyl for export. The drug deprenyl hearing.
convicted of felonies under Federal law was misbranded because it contained In a letter dated May 16, 2005, Mr.
for conduct relating to the regulation of selegiline, the active ingredient of a Kimball responded to the certified letter
a drug product under the act. In prescription drug Eldepryl, but was by requesting a hearing.
addition, Mr. Kimball has failed to file dispensed without a prescription issued
with the agency information and by a licensed practitioner. II. Denial of Hearing
analyses sufficient to create a basis for As a result of these convictions, FDA In his May 16, 2005, request for a
a hearing concerning this action. served Mr. Kimball by certified letter on hearing, Mr. Kimball does not present
DATES: This order is effective January April 25, 2005,1 a proposal to any arguments or information to show
30, 2007. permanently debar him from providing why he should not be debarred. Mr.
ADDRESSES: Submit applications for services in any capacity to a person that Kimball merely states that: (1) He ‘‘was
termination of debarment to the has an approved or pending drug not convicted pursuant to the
Division of Dockets Management (HFA– statements set forth in FDA’s alleged
1 The certified letter was mailed to the prison
305), Food and Drug Administration, notice’’, (2) the allegations of his
facility where records indicated that Mr. Kimball
5630 Fishers Lane, rm. 1061, Rockville, convictions are incorrect, and (3) his
ycherry on PROD1PC64 with NOTICES
was incarcerated, and the return receipt was signed
MD 20852. on April 25, 2005, by an employee at the facility. conviction does not mandate his
FOR FURTHER INFORMATION CONTACT: In his request for hearing, Mr. Kimball stated that debarment. Such statements do not
he received the letter on May 5, 2005. The delivery
Mary Catchings, Center for Drug dates do not alter the nature of Mr. Kimball’s
create a basis for a hearing because
Evaluation and Research (HFD–7), Food request for a hearing or our application of summary hearings will not be granted on mere
and Drug Administration, 5600 Fishers judgement in this matter. allegations, denials, or general
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4270 Federal Register / Vol. 72, No. 19 / Tuesday, January 30, 2007 / Notices
descriptions of positions (see 21 CFR Dated: January 22, 2007. Indevus believes that the risk/benefit
12.24(b)(2)). Although FDA’s proposal Margaret O’K. Glavin, ratio for the use of dexfenfluramine is
to debar Mr. Kimball explained that he Associate Commissioner for Regulatory unfavorable and that withdrawal of
had the opportunity to file a request for Affairs. approval of NDA 20–344 is in the best
a hearing and then submit factual [FR Doc. E7–1416 Filed 1–29–07; 8:45 am] interest of public health. Indevus
information within 60 days from receipt BILLING CODE 4160–01–S voluntarily waived its opportunity for a
of the letter, Mr. Kimball did not submit hearing, provided under § 314.150(a)
any factual information. Mr. Kimball and (b).
has failed to present any arguments or DEPARTMENT OF HEALTH AND Therefore, under section 505(e) of
information to show why he should not HUMAN SERVICES Federal Food, Drug, and Cosmetic Act
be debarred. Therefore, FDA finds that (the act) (21 U.S.C. 355(e)), § 314.150(d),
Mr. Kimball has failed to identify any Food and Drug Administration and under authority delegated to the
genuine and substantial issue of fact [Docket No. 2007N–0029]
Director, Center for Drug Evaluation and
requiring a hearing. Accordingly, FDA Research, by the Commissioner of Food
denies Mr. Kimball’s request for a Indevus Pharmaceuticals, Inc.; and Drugs, approval of NDA 20–544,
hearing. Withdrawal of Approval of a New Drug and all amendments and supplements
Application thereto, is withdrawn, effective January
III. Findings and Order
30, 2007. Distribution of this product in
Therefore, the Associate AGENCY: Food and Drug Administration, interstate commerce without an
Commissioner for Regulatory Affairs, HHS. approved application is illegal and
under section 306(a) of the act and ACTION: Notice. subject to regulatory action (see sections
under authority delegated to him, finds 505(a) and 301(d) of the act (21 U.S.C.
that Mr. James T. Kimball has been SUMMARY: The Food and Drug 331(d)).
convicted of felonies under Federal law Administration (FDA) is withdrawing
approval of a new drug application Dated: January 12, 2007.
for conduct relating to the regulation of
a drug product under the act (section (NDA) for REDUX (dexfenfluramine Douglas C. Throckmorton,
306(a)(2)(B) of the act). hydrochloride (HCl)) Capsules held by Deputy Director, Center for Drug Evaluation
As a result of the foregoing findings, Indevus Pharmaceuticals, Inc. (Indevus), and Research.
Mr. James T. Kimball is permanently 33 Hayden Ave., Lexington, MA 02421– [FR Doc. E7–1414 Filed 1–29–07; 8:45 am]
debarred from providing services in any 7971. Indevus has requested that BILLING CODE 4160–01–S
capacity to a person with an approved approval of this application be
or pending drug product application withdrawn because the product is no
under sections 505, 512, or 802 of the longer marketed, thereby waiving its DEPARTMENT OF HEALTH AND
act (21 U.S.C. 355, 360b, or 382), or opportunity for a hearing. HUMAN SERVICES
under section 351 of the Public Health DATES: Effective January 30, 2007.
Service Act (42 U.S.C. 262), effective Health Resources and Services
FOR FURTHER INFORMATION CONTACT: Administration
(see DATES) (sections 306(c)(1)(B) and Florine P. Purdie, Center for Drug
(c)(2)(A)(iii) and 201(dd) of the act (21 Agency Information Collection
Evaluation and Research (HFD–7), Food
U.S.C. 321(dd))). Any person with an Activities: Proposed Collection:
and Drug Administration, 5600 Fishers
approved or pending drug product Comment Request
Lane, Rockville, MD 20857, 301–594–
application who knowingly uses the
2041. In compliance with the requirement
services of Mr. Kimball in any capacity,
during his period of debarment, will be SUPPLEMENTARY INFORMATION: In 1997, for opportunity for public comment on
subject to civil money penalties (section FDA asked that REDUX proposed data collection projects
307(a)(6) of the act (21 U.S.C. (dexfenfluramine HCl) be withdrawn (section 3506(c)(2)(A) of Title 44, United
335b(a)(6))). If Mr. Kimball, during his from the market because of safety States Code, as amended by the
period of debarment, provides services concerns; Indevus (formerly Interneuron Paperwork Reduction Act of 1995,
in any capacity to a person with an Pharmaceuticals, Inc.) discontinued Public Law 104–13), the Health
approved or pending drug product marketing this product. REDUX Resources and Services Administration
application, he will be subject to civil (dexfenfluramine HCl)Capsules, a (HRSA) publishes periodic summaries
money penalties (section 307(a)(7) of the treatment for obesity, was withdrawn of proposed projects being developed
act). In addition, FDA will not accept or from the market after review of safety for submission to the Office of
review any abbreviated new drug data showed that the product is Management and Budget (OMB) under
applications submitted by or with the associated with valvular heart disease the Paperwork Reduction Act of 1995.
assistance of Mr. Kimball during his (see FDA press releases on ‘‘Health To request more information on the
period of debarment. Advisory on Fenfluramine/Phentermine proposed project or to obtain a copy of
Any application by Mr. Kimball for for Obesity,’’ dated July 8, 1997, (http:// the data collection plans and draft
termination of debarment under section www.fda.gov/opacom/hpnews.html), instruments, call the HRSA Reports
306(d)(4) of the act should be identified and ‘‘FDA Announces Withdrawal of Clearance Officer on (301) 443–1129.
with Docket No. 2005N–0105 and sent Fenfluramine and Dexfenfluramine,’’ Comments are invited on: (a) Whether
to the Division of Dockets Management dated September 15, 1997, (http:// the proposed collection of information
(see ADDRESSES). All such submissions www.fda.gov/opacom/hpnews.html)). is necessary for the proper performance
are to be filed in four copies. The public In a letter dated January 16, 2006, of the functions of the agency, including
availability of information in these Indevus requested that FDA withdraw whether the information shall have
ycherry on PROD1PC64 with NOTICES
submissions is governed by 21 CFR approval, under § 314.150(d) (21 CFR practical utility; (b) the accuracy of the
10.20(j). Publicly available submissions 314.150(d)), of NDA 20–344 for REDUX agency’s estimate of the burden of the
may be seen in the Division of Dockets (dexfenfluramine HCl) Capsules, stating proposed collection of information; (c)
Management between 9 a.m. and 4 p.m., that it had discontinued marketing the ways to enhance the quality, utility, and
Monday through Friday. product. The letter also stated that clarity of the information to be
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