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Federal RegisterVol 74_ No 148Tuesday_ August 4_ 2009Notices

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Federal RegisterVol 74_ No 148Tuesday_ August 4_ 2009Notices Powered By Docstoc
					                                                  38656                         Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices

                                                  faculty at the DISL are actively involved               completing a registration is through the              DATES:   This order is effective August 4,
                                                  in both basic and applied research in                   Web site at https://www.ccr.gov. This                 2009.
                                                  coastal waters of the northern Gulf of                  Web site provides a CCR handbook with                 ADDRESSES: Submit applications for
                                                  Mexico. The DISL operates marine                        detailed information on data you will                 special termination of debarment to the
                                                  research vessels (boats) crewed by                      need prior to beginning the online pre-               Division of Dockets Management (HFA–
                                                  faculty and students for field studies                  registration, as well as steps to walk you            305), Food and Drug Administration,
                                                  and sample collections. DISL possesses                  through the registration process.                     5630 Fishers Lane, rm. 1061, Rockville,
                                                  extensive laboratory and wet-laboratory                    • Step 3: Register With Electronic                 MD 20852.
                                                  resources relevant to the mission of the                Research Administration (eRA)                         FOR FURTHER INFORMATION CONTACT:
                                                  FDA/GCSL. The DISL is located within                    Commons                                               Robert Hummel, Sr., Division of
                                                  1 mile of the FDA/GCSL which will                          Steps 1 and 2, in detail, can be found             Compliance Policy (HFC–230), Office of
                                                  engage the proposed program of                          at http://www07.grants.gov/applicants/                Enforcement, Office of Regulatory
                                                  collaboration and internships. This                     organization_registration.jsp. Step 3, in             Affairs, Food and Drug Administration,
                                                  unique circumstance of capability,                      detail, can be found at https://                      5600 Fishers Lane, Rockville, MD
                                                  capacity and proximity is irreplaceable                 commons.era.nih.gov/commons/                          20857, 240–632–6845.
                                                  without extended and costly                             registration/registrationInstructions.jsp.
                                                                                                                                                                SUPPLEMENTARY INFORMATION:
                                                  concessions.                                            After you have followed these steps,
                                                                                                          submit paper applications to: Camille                 I. Background
                                                  II. Award Information/Funds Available
                                                                                                          Peake, Division of Acquisition Support                   Section 306(a)(2)(A) of the act (21
                                                  A. Award Amount                                         and Grants, Food and Drug                             U.S.C. 335a(a)(2)(A)) requires debarment
                                                    The estimated amount of support in                    Administration (HFA 500), 5630 Fishers                of an individual if FDA finds that the
                                                  FY09 will be up to $250,000 total costs                 Lane, rm. 2139, Rockville, MD 20857,                  individual has been convicted of a
                                                  (direct plus indirect costs).                           301–827–7175, FAX: 301–827–7101, e-                   felony under Federal law for conduct
                                                                                                          mail: Camille.Peake@fda.hhs.gov.                      relating to the development or approval,
                                                  B. Length of Support                                      Dated: July 28, 2009.                               including the process for development
                                                    The award will provide 12 months of                   Jeffrey Shuren,                                       or approval, of any drug product.
                                                  support contingent upon satisfactory                    Associate Commissioner for Policy and                 Section 306(a)(2)(B) of the act requires
                                                  performance in the achievement of                       Planning.                                             debarment of an individual if FDA finds
                                                  project and program reporting.                          [FR Doc. E9–18533Filed 8–3–09; 8:45 am]               that the individual has been convicted
                                                                                                                                                                of a felony under Federal law for
                                                  III. Paper Application, Registration,                   BILLING CODE 4160–01–S
                                                                                                                                                                conduct otherwise relating to the
                                                  and Submission Information
                                                                                                                                                                regulation of any drug product under
                                                     To submit a paper application in                     DEPARTMENT OF HEALTH AND                              the act.
                                                  response to this FOA, applicants should                 HUMAN SERVICES                                           On September 11, 2007, the U.S.
                                                  first review the full announcement                                                                            District Court for the Eastern District of
                                                  located at http://www.cfsan.fda.gov/                    Food and Drug Administration                          Michigan accepted Dr. Hendrick’s guilty
                                                  list.html. Persons interested in applying                                                                     plea and entered judgment against him
                                                  for a grant may obtain an application                   [Docket No. FDA–2008–N–0582]                          for one count of mail fraud, a federal
                                                  from the PHS 398 application                                                                                  felony offense under 18 U.S.C. 1341.
                                                                                                          Kim C. Hendrick: Debarment Order
                                                  instructions available at http://                                                                             This offense was committed when Dr.
                                                  grants.nih.gov/grants/forms.htm. The                    AGENCY:    Food and Drug Administration,              Hendrick was a licensed physician
                                                  following steps are required for paper                  HHS.                                                  practicing medicine in the State of
                                                  submission:                                             ACTION:   Notice.                                     Michigan. Dr. Hendrick agreed to
                                                     • Step 1: Obtain a Dun and Bradstreet                                                                      participate in the clinical research trial
                                                  Number (DUNS)                                           SUMMARY: The Food and Drug                            for Augmentin XR, including its use in
                                                     Applicants are now required to have                  Administration (FDA) is issuing an                    the treatment of adults with Acute
                                                  a DUNS number to apply for a grant or                   order under the Federal Food, Drug, and               Bacterial Sinusitis (ABS). As part of his
                                                  cooperative agreement from the Federal                  Cosmetic Act (the act) permanently                    participation in the clinical study, he
                                                  Government. The DUNS number is a 9-                     debarring Kim C. Hendrick, M.D., from                 agreed to conduct the study in
                                                  digit identification number that                        providing services in any capacity to a               conformity with the protocol
                                                  uniquely identifies business entities. To               person that has an approved or pending                established by GlaxoSmithKline and to
                                                  obtain a DUNS number, call DUN and                      drug product application. We base this                comply with FDA regulations. He also
                                                  Bradstreet at 1–866–705–5711. Be                        order on a finding that Dr. Hendrick was              agreed to take X-rays, before and after
                                                  certain that you identify yourself as a                 convicted of a felony under Federal law               treatment, of persons he diagnosed with
                                                  Federal grant applicant when you                        for conduct relating to the development               ABS, and to have an independent
                                                  contact Dun and Bradstreet. For foreign                 or approval, including the process for                radiologist analyze these and issue
                                                  entities the Web site https://                          development or approval, of a drug                    reports regarding the X-rays.
                                                  eupdate.DNB.com.                                        product, and for conduct otherwise                       Dr. Hendrick admitted that instead of
                                                     • Step 2: Register With Central                      relating to the regulation of a drug                  having an independent radiologist
                                                  Contractor Registration (CCR)                           product under the act. After being given              review the X-rays and issue reports, he
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                                                     Applicants must register with the CCR                notice of the proposed permanent                      allowed certain X-rays to be sent in
                                                  database. You must have a DUNS                          debarment and an opportunity to                       batch form, which was a direct violation
                                                  number to begin your registration. This                 request a hearing within the timeframe                of the protocol. Further, he did not
                                                  database is a government-wide                           prescribed by regulation, Dr. Hendrick                verify the purported signatures of the
                                                  warehouse of commercial and financial                   failed to request a hearing. Dr.                      independent radiologist reports and,
                                                  information for all organizations                       Hendrick’s failure to request a hearing               instead, failed to disclose to
                                                  conducting business with the Federal                    constitutes a waiver of his right to a                GlaxoSmithKline and/or FDA that the
                                                  Government. The preferred method for                    hearing concerning this action.                       signatures were unverified and possibly


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                                                                                Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices                                           38657

                                                  forged, with the intent to create a false               and 321(dd)). Any person with an                      conduct otherwise relating to the
                                                  impression of a state of facts. Dr.                     approved or pending drug product                      regulation of a drug product under the
                                                  Hendrick was paid by GlaxoSmithKline                    application who knowingly employs or                  act. After being given notice of the
                                                  approximately $116,800 in X-ray fees                    retains as a consultant or contractor, or             proposed permanent debarment and an
                                                  for his participation in the clinical                   otherwise uses the services of Dr.                    opportunity to request a hearing within
                                                  research trial. In so doing he caused a                 Hendrick, in any capacity, during Dr.                 the timeframe prescribed by regulation,
                                                  check to be mailed to him through the                   Hendrick’s permanent debarment, will                  Mr. Kornak failed to request a hearing.
                                                  Postal Service at the direction of                      be subject to civil money penalties                   Mr. Kornak’s failure to request a hearing
                                                  GlaxoSmithKline as partial payment for                  (section 307(a)(6) of the act (21 U.S.C.              constitutes a waiver of his right to a
                                                  his participation in the clinical trial for             335b(a)(6))). If Dr. Hendrick, during his             hearing concerning this action.
                                                  the purpose of executing the scheme to                  period of debarment, provides services                DATES: This order is effective August 4,
                                                  defraud.                                                in any capacity to a person with an                   2009.
                                                     As a result of this conviction, FDA                  approved or pending drug product                      ADDRESSES: Submit applications for
                                                  sent Dr. Hendrick by certified mail on                  application, he will be subject to civil              special termination of debarment to the
                                                  May 4, 2009, a notice proposing to                      money penalties (section 307(a)(7) of the             Division of Dockets Management (HFA–
                                                  permanently debar him from providing                    act). In addition, FDA will not accept or             305), Food and Drug Administration,
                                                  services in any capacity to a person that               review any abbreviated new drug                       5630 Fishers Lane, rm. 1061, Rockville,
                                                  has an approved or pending drug                         applications submitted by or with the                 MD 20852.
                                                  product application. The proposal was                   assistance of Dr. Hendrick during his
                                                                                                                                                                FOR FURTHER INFORMATION CONTACT:
                                                  based on a finding, under section                       permanent debarment (section
                                                  306(a)(2)(A) and (a)(2)(B) of the act, that             306(c)(1)(B) of the act).                             Robert L. Hummel, Sr., Division of
                                                  Dr. Hendrick was convicted of a felony                    Any application by Dr. Hendrick for                 Compliance Policy (HFC–230), Office of
                                                  under Federal law for conduct relating                  special termination of debarment under                Enforcement, Office of Regulatory
                                                  to the development or approval of a                     section 306(d)(4) of the act should be                Affairs, Food and Drug Administration,
                                                  drug product, including the process for                 identified with Docket No. FDA–2008–                  5600 Fishers Lane, Rockville, MD
                                                  development or approval of a drug                       N–0582 and sent to the Division of                    20857, 240–632–6845.
                                                  product, and conduct otherwise relating                 Dockets Management (see ADDRESSES).                   SUPPLEMENTARY INFORMATION:
                                                  to the regulation of a drug product                     All such submissions are to be filed in               I. Background
                                                  under the act. The proposal also offered                four copies. The public availability of
                                                  Dr. Hendrick an opportunity to request                  information in these submissions is                      Section 306(a)(2)(A) of the act (21
                                                  a hearing, providing him 30 days from                   governed by 21 CFR 10.20(j).                          U.S.C. 335a(a)(2)(A)) requires debarment
                                                  the date of receipt of the letter in which                Publicly available submissions may                  of an individual if FDA finds that the
                                                  to file the request, and advised him that               be seen in the Division of Dockets                    individual has been convicted of a
                                                  failure to request a hearing constituted                Management between 9 a.m. and 4 p.m.,                 felony under Federal law for conduct
                                                  a waiver of the opportunity for a hearing               Monday through Friday.                                relating to the development or approval,
                                                  and of any contentions concerning this                                                                        including the process for development
                                                                                                             Dated: July 15, 2009.                              or approval, of any drug product.
                                                  action. Dr. Hendrick did not request a                  Alyson L. Saben,
                                                  hearing and has, therefore, waived his                                                                        Section 306(a)(2)(B) of the act requires
                                                                                                          Acting Director, Office of Enforcement, Office        debarment of an individual if FDA finds
                                                  opportunity for a hearing and any                       of Regulatory Affairs.
                                                  contentions concerning his debarment                                                                          that the individual has been convicted
                                                                                                          [FR Doc. E9–18621 Filed 8–3–09; 8:45 am]              of a felony under Federal law for
                                                  (21 CFR part 12).
                                                                                                          BILLING CODE 4160–01–S                                conduct otherwise relating to the
                                                  II. Findings and Order                                                                                        regulation of any drug product under
                                                     Therefore, the Acting Director, Office                                                                     the act.
                                                  of Enforcement, Office of Regulatory                    DEPARTMENT OF HEALTH AND                                 On January 18, 2005, the U.S. District
                                                  Affairs, under section 306(a)(2)(A) and                 HUMAN SERVICES                                        Court for the Northern District of New
                                                  (a)(2)(B) of the act, and under authority                                                                     York accepted Mr. Kornak’s plea of
                                                                                                          Food and Drug Administration
                                                  delegated to the Acting Director (Staff                                                                       guilty and entered judgment against Mr.
                                                  Manual Guide 1410.35), finds that Dr.                   [Docket No. FDA–2007–N–0501]                          Kornak for one count of making and
                                                  Hendrick has been convicted of a felony                                                                       using a materially false statement, one
                                                  under Federal law for conduct relating                  Paul H. Kornak: Debarment Order                       count of mail fraud, and one count of
                                                  to the development or approval of a                     AGENCY:    Food and Drug Administration,              criminally negligent homicide, federal
                                                  drug product, including the process for                 HHS.                                                  felony offenses under 18 U.S.C.
                                                  development or approval, of a drug                      ACTION:   Notice.                                     1001(a)(3), 1341 and 1346, and 13,
                                                  product, and conduct otherwise relating                                                                       respectively. The actions underlying
                                                  to the regulation of a drug product                     SUMMARY: The Food and Drug                            these convictions were committed while
                                                  under the act.                                          Administration (FDA) is issuing an                    Mr. Kornak was employed by the
                                                     As a result of the foregoing finding,                order under the Federal Food, Drug, and               Department of Veterans Affairs as the
                                                  Dr. Hendrick is permanently debarred                    Cosmetic Act (the act) permanently                    coordinator of several clinical studies of
                                                  from providing services in any capacity                 debarring Paul H. Kornak from                         drug products. Mr. Kornak participated
                                                  to a person with an approved or                         providing services in any capacity to a               in a scheme to defraud the sponsors of
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                                                  pending drug product application under                  person that has an approved or pending                these studies by repeatedly submitting
                                                  sections 505, 512, or 802 of the act (21                drug product application. FDA bases                   false documentation and enrolling and
                                                  U.S.C. 355, 360b, or 382), or under                     this order on a finding that Paul H.                  causing to be enrolled persons as study
                                                  section 351 of the Public Health Service                Kornak was convicted of three felonies                subjects who did not qualify under
                                                  Act (42 U.S.C. 262), effective (see DATES)              under Federal law for conduct relating                particular study protocols. Mr. Kornak
                                                  (see sections 306(c)(1)(B) and                          to the development or approval,                       admitted to submitting a case report
                                                  (c)(2)(A)(ii) and 201(dd) of the act (21                including the process for development                 form with regard to a study subject
                                                  U.S.C. 335a(c)(1)(B) and (c)(2)(A)(ii),                 or approval, of a drug product, and for               knowing the document contained


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