Roy Page, M.D.; Debarment Order, 71008-71009 [E8-27803]

Download as PDF 71008 Federal Register / Vol. 73, No. 227 / Monday, November 24, 2008 / Notices sroberts on PROD1PC70 with NOTICES 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 Mr. Kindness 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 an opportunity to request a hearing within the timeframe prescribed by regulation, Mr. Kindness failed to request a hearing. Mr. Kindness’s failure to request a hearing constitutes a waiver of his right to a hearing concerning this action. DATES: This order is effective November 24, 2008. 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: Jennifer J. Ross, Center for Biologics Evaluation and Research (HFM–10), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852– 1448, 301–827–0372. SUPPLEMENTARY INFORMATION: I. Background On September 28, 2006, the U.S. District Court for the Western District of Tennessee accepted George Kindness’s guilty plea to one count of being aided and abetted in the introduction and delivery for introduction into interstate commerce of a misbranded drug with intent to defraud and mislead, a Federal felony offense under sections 301(a) and 303(a)(2) of the act (21 U.S.C. 331(a) and 333(a)(2)) and 18 U.S.C. 2. This offense was committed when Mr. Kindness, president, part-owner and laboratory director of Amscot Medical Labs, Inc., manufactured and shipped a new drug for use in human beings for the treatment of cancer, without an investigational new drug application in effect. As a result of this conviction, FDA sent Mr. Kindness by certified mail on September 7, 2007, a notice proposing to permanently debar Mr. Kindness 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 Mr. Kindness 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 VerDate Aug<31>2005 19:32 Nov 21, 2008 Jkt 217001 (21 U.S.C. 335a(a)(2)(A) and (c)(2)(A)(ii)), that Mr. Kindness 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. Mr. Kindness was provided 30 days to file objections and request a hearing. Mr. Kindness did not request a hearing. Mr. Kindness’s failure to request a hearing constitutes a waiver of his opportunity for a hearing and a waiver of any contentions concerning his debarment (21 CFR part 12). 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 Mr. Kindness 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, Mr. Kindness 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 Mr. Kindness, in any capacity, during Mr. Kindness’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 Mr. Kindness, during his 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, Mr. Kindness will be subject to civil money penalties (section 307(a)(7) of the act). In addition, FDA will not accept or review any abbreviated drug applications submitted by or with the assistance of Mr. Kindness during Mr. Kindness’s permanent debarment (section 306(c)(1)(B) of the act). Any application by Mr. Kindness for termination of debarment under section 306(d)(4) of the act should be identified with Docket No. FDA–2007–N–0474 (formerly Docket No. 2007N–0292) and sent to the Division of Dockets PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 Management (see ADDRESSES). All such submissions are to be filed in four copies (§ 10.20(a) (21 CFR 10.20(a))). The public availability of information in these submissions is governed by § 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 (§ 10.20(j)(1)). Dated: November 12, 2008. Jesse Goodman, Director, Center for Biologics Evaluation and Research. [FR Doc. E8–27802 Filed 11–21–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–N–0488] (formerly Docket No. 2007N–0291) Roy Page, M.D.; Debarment Order AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) permanently debarring Dr. Roy Page 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 Dr. Page 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 an opportunity to request a hearing within the timeframe prescribed by regulation, Dr. Page failed to request a hearing. Dr. Page’s failure to request a hearing constitutes a waiver of his right to a hearing concerning this action. DATES: This order is effective November 24, 2008. 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: Jennifer J. Ross, Center for Biologics Evaluation and Research (HFM–10), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852– 1448, 301–827–0372. E:\FR\FM\24NON1.SGM 24NON1 Federal Register / Vol. 73, No. 227 / Monday, November 24, 2008 / Notices SUPPLEMENTARY INFORMATION: sroberts on PROD1PC70 with NOTICES I. Background On August 4, 2005, the U.S. District Court for the Western District of Tennessee accepted Dr. Roy Page’s guilty plea to one count of introduction and delivery for introduction into interstate commerce of a misbranded drug with the intent to mislead the FDA, a Federal felony offense under sections 301(a) and 303(a)(2) of the act (21 U.S.C. 331(a) and 333(a)(2). This offense was committed when Dr. Page shipped tumor tissue and blood samples to Amscot Medical Laboratories, Inc., for manufacture of a new drug for the treatment of cancer in human beings without an investigational new drug application in effect. As a result of this conviction, FDA sent Dr. Page by certified mail on September 7, 2007, a notice proposing to permanently debar Dr. Page 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 Dr. Page 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 Dr. Page 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. Dr. Page was provided 30 days to file objections and request a hearing. Dr. Page did not request a hearing. Dr. Page’s failure to request a hearing constitutes a waiver of his opportunity for a hearing and a waiver of any contentions concerning his debarment (21 CFR part 12). 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 Dr. Page 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, Dr. Page 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 VerDate Aug<31>2005 19:32 Nov 21, 2008 Jkt 217001 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 Dr. Page, in any capacity, during Dr. Page’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 Dr. Page, during his 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, Dr. Page will be subject to civil money penalties (section 307(a)(7) of the act). In addition, FDA will not accept or review any abbreviated drug applications submitted by or with the assistance of Dr. Page during Dr. Page’s permanent debarment (section 306(c)(1)(B) of the act). Any application by Dr. Page for termination of debarment under section 306(d)(4) of the act should be identified with Docket No. FDA–2007–N–0488 (formerly Docket No. 2007N–0291) and sent to the Division of Dockets Management (see ADDRESSES). All such submissions are to be filed in four copies (§ 10.20(a) (21 CFR 10.20(a))). The public availability of information in these submissions is governed by § 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 (§ 10.20(j)(1)). Dated: November 12, 2008. Jesse Goodman, Director, Center for Biologics Evaluation and Research. [FR Doc. E8–27803 Filed 11–21–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–D–0592] Draft Guidance for Industry on the Contents of a Complete Submission for the Evaluation of Proprietary Names; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Contents of a Complete Submission for the Evaluation PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 71009 of Proprietary Names.’’ This draft guidance provides recommendations to industry regarding the submission of a complete package that FDA intends to use to assess the safety of proposed proprietary drug and biological product names and other factors that, in association with the name, can contribute to medication errors. In addition, FDA intends to use this information in the assessment of promotional aspects of proposed proprietary names. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by January 23, 2009. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD– 240), Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993–0002; or the Office of Communication, Training, and Manufacturers Assistance (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852–1448. The draft guidance may also be obtained by mail by calling CBER at 1–800–835–4709 or 301–827–1800. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the draft guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Carol Holquist, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4416, Silver Spring, MD 20993–0002, 301– 796–2360, or Stephen Ripley, 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 FDA is announcing the availability of a draft guidance for industry entitled ‘‘Contents of a Complete Submission for E:\FR\FM\24NON1.SGM 24NON1

Agencies

[Federal Register Volume 73, Number 227 (Monday, November 24, 2008)]
[Notices]
[Pages 71008-71009]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-27803]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-N-0488] (formerly Docket No. 2007N-0291)


Roy Page, M.D.; Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is issuing an order 
under the Federal Food, Drug, and Cosmetic Act (the act) permanently 
debarring Dr. Roy Page 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 Dr. Page 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 an opportunity to request a hearing within the timeframe 
prescribed by regulation, Dr. Page failed to request a hearing. Dr. 
Page's failure to request a hearing constitutes a waiver of his right 
to a hearing concerning this action.

DATES: This order is effective November 24, 2008.

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: Jennifer J. Ross, Center for Biologics 
Evaluation and Research (HFM-10), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-827-0372.

[[Page 71009]]


SUPPLEMENTARY INFORMATION:

I. Background

    On August 4, 2005, the U.S. District Court for the Western District 
of Tennessee accepted Dr. Roy Page's guilty plea to one count of 
introduction and delivery for introduction into interstate commerce of 
a misbranded drug with the intent to mislead the FDA, a Federal felony 
offense under sections 301(a) and 303(a)(2) of the act (21 U.S.C. 
331(a) and 333(a)(2). This offense was committed when Dr. Page shipped 
tumor tissue and blood samples to Amscot Medical Laboratories, Inc., 
for manufacture of a new drug for the treatment of cancer in human 
beings without an investigational new drug application in effect.
    As a result of this conviction, FDA sent Dr. Page by certified mail 
on September 7, 2007, a notice proposing to permanently debar Dr. Page 
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 Dr. Page 
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 Dr. Page 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. Dr. Page was provided 30 days to file objections and request a 
hearing. Dr. Page did not request a hearing. Dr. Page's failure to 
request a hearing constitutes a waiver of his opportunity for a hearing 
and a waiver of any contentions concerning his debarment (21 CFR part 
12).

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 
Dr. Page 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, Dr. Page 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 Dr. Page, in any 
capacity, during Dr. Page'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 Dr. Page, during his 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, Dr. Page will be subject to civil money penalties (section 
307(a)(7) of the act). In addition, FDA will not accept or review any 
abbreviated drug applications submitted by or with the assistance of 
Dr. Page during Dr. Page's permanent debarment (section 306(c)(1)(B) of 
the act).
    Any application by Dr. Page for termination of debarment under 
section 306(d)(4) of the act should be identified with Docket No. FDA-
2007-N-0488 (formerly Docket No. 2007N-0291) and sent to the Division 
of Dockets Management (see ADDRESSES). All such submissions are to be 
filed in four copies (Sec.  10.20(a) (21 CFR 10.20(a))). The public 
availability of information in these submissions is governed by Sec.  
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 
(Sec.  10.20(j)(1)).

    Dated: November 12, 2008.
Jesse Goodman,
Director, Center for Biologics Evaluation and Research.
[FR Doc. E8-27803 Filed 11-21-08; 8:45 am]
BILLING CODE 4160-01-S

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