Glen R. Justice: Debarment Order, 40366-40367 [2012-16600]

Download as PDF sroberts on DSK5SPTVN1PROD with NOTICES 40366 Federal Register / Vol. 77, No. 131 / Monday, July 9, 2012 / Notices terms of points of view represented and the board’s function. Consideration is given to a broad representation of geographic areas within the U.S., as well as gender, race, ethnicity, persons with disabilities, and several factors including: (1) The committee’s mission; (2) the geographic, ethnic, social, economic, or scientific impact of the advisory committee’s recommendations; (3) the types of specific perspectives required, for example, those of consumers, technical experts, the public at-large, academia, business, or other sectors; (4) the need to obtain divergent points of view on the issues before the advisory committee; and (5) the relevance of State, local, or tribal governments to the development of the advisory committee’s recommendations. Nominees must be U.S. citizens. The following information must be submitted for each candidate: Name, affiliation, address, telephone number, and current curriculum vitae. Email addresses are requested if available. Nominations should be sent, in writing, and postmarked by September 30, 2012, to: Sandra Malcom, Committee Management Specialist, NCEH/ATSDR, CDC, 4770 Buford Highway (MS–F61), Chamblee, Georgia 30341, Email address: sym6@CDC.GOV. Telephone and facsimile submissions cannot be accepted. Candidates invited to serve will be asked to submit the ‘‘Confidential Financial Disclosure Form (OGE Form 450) for Special Government Employees Serving on Federal Advisory Committees at the Centers for Disease Control and Prevention.’’ This form allows CDC to determine whether there is a statutory conflict between that person’s public responsibilities as a Special Government Employee and private interests and activities, or the appearance of a lack of impartiality, as defined by Federal regulation. The form may be viewed and downloaded at https://www.usoge.gov/forms/ oge450_pdf/oge450_accessible.pdf. This form should not be submitted as part of a nomination. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention, and the Agency for Toxic Substances and Disease Registry. VerDate Mar<15>2010 16:20 Jul 06, 2012 Jkt 226001 Dated: June 28, 2012. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2012–16636 Filed 7–6–12; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0860] Glen R. Justice: Debarment Order AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Glen R. Justice, M.D. from providing services in any capacity to a person that has an approved or pending drug product application for a period of 25 years. We base this order on a finding that Dr. Justice was convicted of five felony counts under Federal law for conduct involving health care fraud and that this pattern of conduct was sufficient to find that there is reason to believe he may violate requirements under the FD&C Act relating to drug products. Dr. Justice was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Justice failed to respond. Dr. Justice’s failure to respond constitutes a waiver of his right to a hearing concerning this action. DATES: This order is effective July 9, 2012. SUMMARY: Submit applications for special 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: Kenny Shade, Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857, 301–796–4640. SUPPLEMENTARY INFORMATION: ADDRESSES: I. Background Section 306(b)(2)(B)(ii)(I) of the FD&C Act (21 U.S.C. 335a(b)(2)(B)(ii)(I)) permits debarment of an individual if FDA finds that the individual has been convicted of a felony under Federal law for conduct which involves bribery, payment of illegal gratuities, fraud, PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 perjury, false statement, racketeering, blackmail, extortion, falsification or destruction of records, or interference with, obstruction of an investigation into, or prosecution of any criminal offense, and it finds, on the basis of the conviction and other information, that such individual has demonstrated a pattern of conduct sufficient to find that there is reason to believe the individual may violate requirements under the FD&C Act relating to drug products. On July 25, 2011, the U.S. District Court for the Central District of California entered judgment against Dr. Justice for health care fraud in violation of 18 U.S.C. 1347, and aiding and abetting and causing an act to be done in violation of 18 U.S.C. 2. The FDA’s finding that debarment is appropriate is based on the felony convictions referenced herein. The factual basis for this conviction is as follows: Dr. Justice was a physician licensed by the State of California. Dr. Justice owned and operated a medical practice in the Central District of California and he enrolled as a provider with federally-funded and private health care programs. Dr. Justice devised and executed a scheme to defraud federally-funded and private health care benefit programs. As part of the scheme, Dr. Justice knowingly and willfully submitted, and caused to be submitted, false and fraudulent claims to health care benefit programs for injectable medications, knowing that those medications were never provided to the patients and he billed patients health care benefit programs for more expensive injectable medications when less expensive medications were provided. Dr. Justice continued his conduct despite being advised by staff to desist and subsequent to the execution of a search warrant at his medical practice in 2006. As a result of Dr. Justice’s fraudulent business practices, health care benefit programs suffered losses between $400,000 and $1,000,000. As a result of his convictions, on March 26, 2012, FDA sent Dr. Justice a notice by certified mail proposing to debar him for 25 years from providing services in any capacity to a person that has an approved or pending drug product application. The proposal was based on the finding, under section 306(b)(2)(B)(ii)(I) of the FD&C Act, that Dr. Justice was convicted of felonies under Federal law for conduct which involved health care fraud, and that the Agency found, on the basis of the conviction and other information, that Dr. Justice had demonstrated a pattern of conduct sufficient to find that there is reason to believe he may violate E:\FR\FM\09JYN1.SGM 09JYN1 Federal Register / Vol. 77, No. 131 / Monday, July 9, 2012 / Notices sroberts on DSK5SPTVN1PROD with NOTICES requirements under the FD&C Act relating to drug products. This conclusion was based on the fact that Dr. Justice had legal and professional obligations to ensure that he submitted accurate medical claims for procedures he performed, as well as administering medicines that were appropriate for his patients’ condition, which he knowingly and willingly disregarded, as well as the fact that Dr. Justice intentionally billed for different FDA-regulated drug products than what he wrote prescriptions for. Therefore, FDA had reason to believe that, if Dr. Justice were to provide services to a person that has an approved or pending drug application, he may violate requirements under the FD&C Act relating to drug products. The proposal offered Dr. Justice an opportunity to request a hearing, providing him 30 days from the date of receipt of the letter in which to file the request, and advised him that failure to request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. The proposal was received on March 29, 2012. Dr. Justice failed to respond within the timeframe prescribed by regulation and has, therefore, waived his opportunity for a hearing and has waived any contentions concerning his debarment (21 CFR part 12). II. Findings and Order Therefore, the Director, Office of Enforcement, Office of Regulatory Affairs, under section 306(b)(2)(B)(ii)(I) of the FD&C Act, under authority delegated to the Director (Staff Manual Guide 1410.35), finds that Glen R. Justice has been convicted of five counts of a felony under Federal law for conduct involving health care fraud, and, on the basis of the conviction and other information, finds that Dr. Justice has demonstrated a pattern of conduct sufficient to find that there is reason to believe he may violate requirements under the FD&C Act relating to drug products. As a result of the foregoing finding, Dr. Justice is debarred for 25 years from providing services in any capacity to a person with an approved or pending drug product application under sections 505, 512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section 351 of the Public Health Service Act (42 U.S.C. 262), effective (see DATES) (see sections 306(c)(1)(B), (c)(2)(A)(ii), and 201(dd) of the FD&C Act (21 U.S.C. 335a(c)(1)(B), (c)(2)(A)(ii), and 321(dd))). Any person with an approved or pending drug product application who knowingly employs or retains as a consultant or contractor, or otherwise VerDate Mar<15>2010 16:20 Jul 06, 2012 Jkt 226001 uses the services of Dr. Justice, in any capacity during Dr. Justice’s debarment, will be subject to civil money penalties (section 307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))). If Dr. Justice provides services in any capacity to a person with an approved or pending drug product application during his period of debarment he will be subject to civil money penalties (section 307(a)(7) of the FD&C Act). In addition, FDA will not accept or review any abbreviated new drug applications submitted by or with the assistance of Dr. Justice during his period of debarment (section 306(c)(1)(A) of the FD&C Act). Any application by Dr. Justice for special termination of debarment under section 306(d)(4) of the FD&C Act (21 U.S.C. 335a(d)(4)) should be identified with Docket No. FDA–2011–N–0860 and sent to the Division of Dockets Management (see ADDRESSES). All such submissions are to be filed in four copies. The public availability of information in these submissions is governed by 21 CFR 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. Dated: June 22, 2012. Armando Zamora, Acting Director, Office of Enforcement, Office of Regulatory Affairs. [FR Doc. 2012–16600 Filed 7–6–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0690] 40367 Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6366, Silver Spring, MD 20993–0002, 301– 796–3601. SUPPLEMENTARY INFORMATION: In June 1998, Wyeth voluntarily withdrew DURACT (bromfenac sodium) Capsules from the market. DURACT (bromfenac sodium) Capsules, a nonsteroidal antiinflammatory drug indicated for the short-term management of acute and chronic pain, were withdrawn from the market after FDA and Wyeth received postmarketing reports of rare, severe liver toxicity in patients who took DURACT for periods of time beyond that recommended in the labeling. In a letter dated December 9, 2011, Wyeth requested that FDA withdraw approval of NDA 20–535, DURACT (bromfenac sodium) Capsules, under § 314.150(d) (21 CFR 314.150(d)). In that letter, Wyeth also waived its opportunity for a hearing, provided under § 314.150(a). Therefore, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)) and § 314.150(d), and under authority delegated by the Commissioner of Food and Drugs to the Director, Center for Drug Evaluation and Research, approval of NDA 20–535, and all amendments and supplements thereto, is withdrawn (see DATES). Distribution of this product in interstate commerce without an approved application is illegal and subject to regulatory action (see sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)). Dated: June 21, 2012. Janet Woodcock, Director, Center for Drug Evaluation and Research. [FR Doc. 2012–16597 Filed 7–6–12; 8:45 am] Wyeth Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for DURACT Capsules AGENCY: Food and Drug Administration, HHS. ACTION: The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for DURACT (bromfenac sodium) Capsules, held by Wyeth Pharmaceuticals, Inc. (Wyeth), P.O. Box 8299, Philadelphia, PA 19101–8299. Wyeth, now a part of Pfizer, Inc., has voluntarily requested that approval of this application be withdrawn, thereby waiving its opportunity for a hearing. DATES: Effective July 9, 2012. FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug Frm 00048 Fmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Notice. SUMMARY: PO 00000 BILLING CODE 4160–01–P Sfmt 4703 National Eye Institute; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, E:\FR\FM\09JYN1.SGM 09JYN1

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[Federal Register Volume 77, Number 131 (Monday, July 9, 2012)]
[Notices]
[Pages 40366-40367]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-16600]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0860]


Glen R. Justice: 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 FD&C Act) debarring 
Glen R. Justice, M.D. from providing services in any capacity to a 
person that has an approved or pending drug product application for a 
period of 25 years. We base this order on a finding that Dr. Justice 
was convicted of five felony counts under Federal law for conduct 
involving health care fraud and that this pattern of conduct was 
sufficient to find that there is reason to believe he may violate 
requirements under the FD&C Act relating to drug products. Dr. Justice 
was given notice of the proposed debarment and an opportunity to 
request a hearing within the timeframe prescribed by regulation. Dr. 
Justice failed to respond. Dr. Justice's failure to respond constitutes 
a waiver of his right to a hearing concerning this action.

DATES: This order is effective July 9, 2012.

ADDRESSES: Submit applications for special 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: Kenny Shade, Office of Regulatory 
Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rockville, 
MD 20857, 301-796-4640.

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 306(b)(2)(B)(ii)(I) of the FD&C Act (21 U.S.C. 
335a(b)(2)(B)(ii)(I)) permits debarment of an individual if FDA finds 
that the individual has been convicted of a felony under Federal law 
for conduct which involves bribery, payment of illegal gratuities, 
fraud, perjury, false statement, racketeering, blackmail, extortion, 
falsification or destruction of records, or interference with, 
obstruction of an investigation into, or prosecution of any criminal 
offense, and it finds, on the basis of the conviction and other 
information, that such individual has demonstrated a pattern of conduct 
sufficient to find that there is reason to believe the individual may 
violate requirements under the FD&C Act relating to drug products.
    On July 25, 2011, the U.S. District Court for the Central District 
of California entered judgment against Dr. Justice for health care 
fraud in violation of 18 U.S.C. 1347, and aiding and abetting and 
causing an act to be done in violation of 18 U.S.C. 2.
    The FDA's finding that debarment is appropriate is based on the 
felony convictions referenced herein. The factual basis for this 
conviction is as follows: Dr. Justice was a physician licensed by the 
State of California. Dr. Justice owned and operated a medical practice 
in the Central District of California and he enrolled as a provider 
with federally-funded and private health care programs.
    Dr. Justice devised and executed a scheme to defraud federally-
funded and private health care benefit programs. As part of the scheme, 
Dr. Justice knowingly and willfully submitted, and caused to be 
submitted, false and fraudulent claims to health care benefit programs 
for injectable medications, knowing that those medications were never 
provided to the patients and he billed patients health care benefit 
programs for more expensive injectable medications when less expensive 
medications were provided. Dr. Justice continued his conduct despite 
being advised by staff to desist and subsequent to the execution of a 
search warrant at his medical practice in 2006. As a result of Dr. 
Justice's fraudulent business practices, health care benefit programs 
suffered losses between $400,000 and $1,000,000.
    As a result of his convictions, on March 26, 2012, FDA sent Dr. 
Justice a notice by certified mail proposing to debar him for 25 years 
from providing services in any capacity to a person that has an 
approved or pending drug product application. The proposal was based on 
the finding, under section 306(b)(2)(B)(ii)(I) of the FD&C Act, that 
Dr. Justice was convicted of felonies under Federal law for conduct 
which involved health care fraud, and that the Agency found, on the 
basis of the conviction and other information, that Dr. Justice had 
demonstrated a pattern of conduct sufficient to find that there is 
reason to believe he may violate

[[Page 40367]]

requirements under the FD&C Act relating to drug products. This 
conclusion was based on the fact that Dr. Justice had legal and 
professional obligations to ensure that he submitted accurate medical 
claims for procedures he performed, as well as administering medicines 
that were appropriate for his patients' condition, which he knowingly 
and willingly disregarded, as well as the fact that Dr. Justice 
intentionally billed for different FDA-regulated drug products than 
what he wrote prescriptions for. Therefore, FDA had reason to believe 
that, if Dr. Justice were to provide services to a person that has an 
approved or pending drug application, he may violate requirements under 
the FD&C Act relating to drug products. The proposal offered Dr. 
Justice an opportunity to request a hearing, providing him 30 days from 
the date of receipt of the letter in which to file the request, and 
advised him that failure to request a hearing constituted a waiver of 
the opportunity for a hearing and of any contentions concerning this 
action. The proposal was received on March 29, 2012. Dr. Justice failed 
to respond within the timeframe prescribed by regulation and has, 
therefore, waived his opportunity for a hearing and has waived any 
contentions concerning his debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Director, Office of Enforcement, Office of 
Regulatory Affairs, under section 306(b)(2)(B)(ii)(I) of the FD&C Act, 
under authority delegated to the Director (Staff Manual Guide 1410.35), 
finds that Glen R. Justice has been convicted of five counts of a 
felony under Federal law for conduct involving health care fraud, and, 
on the basis of the conviction and other information, finds that Dr. 
Justice has demonstrated a pattern of conduct sufficient to find that 
there is reason to believe he may violate requirements under the FD&C 
Act relating to drug products.
    As a result of the foregoing finding, Dr. Justice is debarred for 
25 years from providing services in any capacity to a person with an 
approved or pending drug product application under sections 505, 512, 
or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section 
351 of the Public Health Service Act (42 U.S.C. 262), effective (see 
DATES) (see sections 306(c)(1)(B), (c)(2)(A)(ii), and 201(dd) of the 
FD&C Act (21 U.S.C. 335a(c)(1)(B), (c)(2)(A)(ii), and 321(dd))). Any 
person with an approved or pending drug product application who 
knowingly employs or retains as a consultant or contractor, or 
otherwise uses the services of Dr. Justice, in any capacity during Dr. 
Justice's debarment, will be subject to civil money penalties (section 
307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))). If Dr. Justice 
provides services in any capacity to a person with an approved or 
pending drug product application during his period of debarment he will 
be subject to civil money penalties (section 307(a)(7) of the FD&C 
Act). In addition, FDA will not accept or review any abbreviated new 
drug applications submitted by or with the assistance of Dr. Justice 
during his period of debarment (section 306(c)(1)(A) of the FD&C Act).
    Any application by Dr. Justice for special termination of debarment 
under section 306(d)(4) of the FD&C Act (21 U.S.C. 335a(d)(4)) should 
be identified with Docket No. FDA-2011-N-0860 and sent to the Division 
of Dockets Management (see ADDRESSES). All such submissions are to be 
filed in four copies. The public availability of information in these 
submissions is governed by 21 CFR 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.

    Dated: June 22, 2012.
Armando Zamora,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2012-16600 Filed 7-6-12; 8:45 am]
BILLING CODE 4160-01-P

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