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					                                                                        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

                                           Total                                                                                                                                              86,407
                                            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
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                                                                                                   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
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                                         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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