Albert Poet: Debarment Order, 11789-11790 [2011-4778]

Download as PDF 11789 Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Portion of study Annual frequency per response Total annual responses Hours per response Total hours Screener ............................................................................... Pretest .................................................................................. Experiment ........................................................................... 10,000 150 5,000 1 1 1 10,000 150 5,000 0.0055 0.42 0.25 55 63 1,250 Total .............................................................................. ........................ ........................ ........................ ........................ 1,368 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: February 25, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. the Internet at https://www.reginfo.gov/ public/do/PRAMain. Dated: February 16, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–4740 Filed 3–2–11; 8:45 am] BILLING CODE 4160–01–P [FR Doc. 2011–4738 Filed 3–2–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES A copy of the supporting statement for this information collection is available on the Internet at https:// www.reginfo.gov/public/do/PRAMain. Dated: February 23, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–4739 Filed 3–2–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food and Drug Administration DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA–2006–N–0238] (formerly 2006N–0062) Food and Drug Administration [Docket No. FDA–2010–N–0344] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Testing Communications on Medical Devices and Radiation-Emitting Products AGENCY: Food and Drug Administration, HHS. ACTION: AGENCY: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Testing Communications on Medical Devices and Radiation-Emitting Products’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 5156, Daniel.Gittleson@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In the Federal Register of October 18, 2010 (75 FR 63838), the Agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0678. The approval expires on January 31, 2014. A copy of the supporting statement for this information collection is available on srobinson on DSKHWCL6B1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 16:47 Mar 02, 2011 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Expanded Access to Investigational Drugs for Treatment Use Jkt 223001 Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Expanded Access to Investigational Drugs for Treatment Use’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, 301– 796–3792, Elizabeth.Berbakos@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In the Federal Register of December 14, 2006 (71 FR 75147), the Agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0653. The approval expires on December 31, 2011. SUMMARY: PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 [Docket No. FDA–2010–N–0478] Albert Poet: 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) permanently debarring Albert Poet, MD from providing services in any capacity to a person that has an approved or pending drug product application. We base this order on a finding that Dr. Poet was convicted of felonies under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. Dr. Poet was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Poet failed to respond. Dr. Poet’s failure to respond constitutes a waiver of his right to a hearing concerning this action. DATES: This order is effective March 3, 2011. 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, Division of Compliance Policy (HFC–230), Office of Enforcement, Office of Regulatory SUMMARY: E:\FR\FM\03MRN1.SGM 03MRN1 11790 Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Notices srobinson on DSKHWCL6B1PROD with NOTICES Affairs, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 240–632–6844. SUPPLEMENTARY INFORMATION: I. Background Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B)) requires debarment of an individual if FDA finds that the individual has been convicted of a felony under Federal law for conduct otherwise relating to the regulation of any drug product under the FD&C Act. On September 28, 2007, the U.S. District Court District of New Jersey entered judgment against Dr. Poet for 13 counts of mail fraud in violation of 18 U.S.C. 2 and 1341 and 1 count of causing a drug to be misbranded while it was held for sale after shipment in interstate commerce with the intent to defraud or mislead in violation of 21 U.S.C. 331(k), 333(a)(2), and 352(i)(3). FDA’s finding that debarment is appropriate is based on the felony convictions referenced herein for conduct relating to the regulation of a drug product. The factual basis for those convictions is as follows: During 2003– 2004, Dr. Poet was a physician licensed to practice medicine in the State of New Jersey. Dr. Poet owned and operated the Shore Laser Center and PEAU, both located in New Jersey. As part of his practice, Dr. Poet injected patients with BOTOX, a Botulinum Toxin Type A drug. From on or about December 4, 2003, through in or about December 2004, Dr. Poet knowingly and willfully devised a scheme and artifice to defraud and to obtain money and property by means of false and fraudulent pretenses, representations, and promises. He maintained a Web site and placed regular advertisements in local newspapers offering BOTOX treatments at his office. Between December 4, 2003, and November 8, 2004, Dr. Poet placed 13 orders for a total of 26 vials of TRI– Toxin, a Botulinum Toxin Type A drug manufactured by Toxin Research International, Inc. TRI–Toxin was labeled ‘‘For Research Purposes Only, Not for Human Use.’’ Dr. Poet injected many of the approximately 130 patients who sought BOTOX treatments with unapproved TRI–Toxin between January 1, 2004, and December 1, 2004. As part of his scheme to defraud, Dr. Poet did not inform most of his patients receiving the TRI–Toxin injections that they were receiving injections of a product not approved by FDA. Dr. Poet charged patients the same price for the cheaper, unapproved TRI–Toxin and the approved BOTOX. For purposes of executing the scheme and artifice, Dr. VerDate Mar<15>2010 16:47 Mar 02, 2011 Jkt 223001 Poet knowingly and willfully caused the TRI–Toxin to be delivered by private and commercial interstate carrier. As a result of his convictions, on December 13, 2010, FDA sent Dr. Poet a notice by certified mail proposing to permanently debar him from providing services in any capacity to a person that has an approved or pending drug product application. The proposal was based on a finding, under section 306(a)(2)(B) of the FD&C Act, that Dr. Poet was convicted of felonies under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. The proposal also offered Dr. Poet 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. Dr. Poet failed to respond within the timeframe prescribed by regulation and has, therefore, waived his opportunity for a hearing and 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(a)(2)(B) of the FD&C Act, under authority delegated to the Director (Staff Manual Guide 1410.35), finds that Albert Poet has been convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. As a result of the foregoing finding, Dr. Poet is permanently debarred 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) (see DATES) (see sections 306(c)(1)(B) and (c)(2)(A)(ii), and 201(dd) of the FD&C Act (21 U.S.C. 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. Poet, in any capacity during Dr. Poet’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. Poet 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. Poet during his PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 period of debarment (section 306(c)(1)(B) of the FD&C Act). Any application by Dr. Poet for special termination of debarment under section 306(d)(4) of the FD&C Act should be identified with Docket No. FDA–2010–N–0478 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: February 16, 2011. Howard Sklamberg, Director, Office of Enforcement, Office of Regulatory Affairs. [FR Doc. 2011–4778 Filed 3–2–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–1981–N–0077 (formerly 81N–0393), FDA–1981–N–0248 (formerly 81N–0396), FDA–1982–N–0046 (formerly 82N–0095), FDA–1982–N–0264 (formerly 82N–0096), and FDA–1983–N–0137 (formerly 83N–0095); DESI 6514, 11935, and 12152] Drugs for Human Use; Drug Efficacy Study Implementation; Oral Prescription Drugs Offered for Relief of Symptoms of Cough, Cold, or Allergy; Withdrawal of Hearing Requests; Final Resolution of Dockets AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that all outstanding hearing requests pertaining to oral prescription drugs offered for relief of symptoms of cough, cold, or allergy, Docket Nos. FDA–1981– N–0077 (formerly 81N–0393), FDA– 1981–N–0248 (formerly 81N–0396), FDA–1982–N–0046 (formerly 82N– 0095), FDA–1982–N–0264 (formerly 82N–0096), and FDA–1983–N–0137 (formerly 83N–0095), have been withdrawn. Therefore, shipment in interstate commerce of the products identified in those dockets, or any identical, related, or similar (IRS) product that is not the subject of an approved new drug application (NDA) or abbreviated new drug application (ANDA) (other than an over-the-counter (OTC) product that complies with an SUMMARY: E:\FR\FM\03MRN1.SGM 03MRN1

Agencies

[Federal Register Volume 76, Number 42 (Thursday, March 3, 2011)]
[Notices]
[Pages 11789-11790]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-4778]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0478]


Albert Poet: 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) 
permanently debarring Albert Poet, MD from providing services in any 
capacity to a person that has an approved or pending drug product 
application. We base this order on a finding that Dr. Poet was 
convicted of felonies under Federal law for conduct relating to the 
regulation of a drug product under the FD&C Act. Dr. Poet was given 
notice of the proposed permanent debarment and an opportunity to 
request a hearing within the timeframe prescribed by regulation. Dr. 
Poet failed to respond. Dr. Poet's failure to respond constitutes a 
waiver of his right to a hearing concerning this action.

DATES: This order is effective March 3, 2011.


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, Division of Compliance 
Policy (HFC-230), Office of Enforcement, Office of Regulatory

[[Page 11790]]

Affairs, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 240-632-6844.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B)) 
requires debarment of an individual if FDA finds that the individual 
has been convicted of a felony under Federal law for conduct otherwise 
relating to the regulation of any drug product under the FD&C Act.
    On September 28, 2007, the U.S. District Court District of New 
Jersey entered judgment against Dr. Poet for 13 counts of mail fraud in 
violation of 18 U.S.C. 2 and 1341 and 1 count of causing a drug to be 
misbranded while it was held for sale after shipment in interstate 
commerce with the intent to defraud or mislead in violation of 21 
U.S.C. 331(k), 333(a)(2), and 352(i)(3).
    FDA's finding that debarment is appropriate is based on the felony 
convictions referenced herein for conduct relating to the regulation of 
a drug product. The factual basis for those convictions is as follows: 
During 2003-2004, Dr. Poet was a physician licensed to practice 
medicine in the State of New Jersey. Dr. Poet owned and operated the 
Shore Laser Center and PEAU, both located in New Jersey. As part of his 
practice, Dr. Poet injected patients with BOTOX, a Botulinum Toxin Type 
A drug.
    From on or about December 4, 2003, through in or about December 
2004, Dr. Poet knowingly and willfully devised a scheme and artifice to 
defraud and to obtain money and property by means of false and 
fraudulent pretenses, representations, and promises. He maintained a 
Web site and placed regular advertisements in local newspapers offering 
BOTOX treatments at his office. Between December 4, 2003, and November 
8, 2004, Dr. Poet placed 13 orders for a total of 26 vials of TRI-
Toxin, a Botulinum Toxin Type A drug manufactured by Toxin Research 
International, Inc. TRI-Toxin was labeled ``For Research Purposes Only, 
Not for Human Use.'' Dr. Poet injected many of the approximately 130 
patients who sought BOTOX treatments with unapproved TRI-Toxin between 
January 1, 2004, and December 1, 2004. As part of his scheme to 
defraud, Dr. Poet did not inform most of his patients receiving the 
TRI-Toxin injections that they were receiving injections of a product 
not approved by FDA. Dr. Poet charged patients the same price for the 
cheaper, unapproved TRI-Toxin and the approved BOTOX. For purposes of 
executing the scheme and artifice, Dr. Poet knowingly and willfully 
caused the TRI-Toxin to be delivered by private and commercial 
interstate carrier.
    As a result of his convictions, on December 13, 2010, FDA sent Dr. 
Poet a notice by certified mail proposing to permanently debar him from 
providing services in any capacity to a person that has an approved or 
pending drug product application. The proposal was based on a finding, 
under section 306(a)(2)(B) of the FD&C Act, that Dr. Poet was convicted 
of felonies under Federal law for conduct relating to the regulation of 
a drug product under the FD&C Act. The proposal also offered Dr. Poet 
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. Dr. Poet failed to respond within the timeframe prescribed by 
regulation and has, therefore, waived his opportunity for a hearing and 
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(a)(2)(B) of the FD&C Act, under 
authority delegated to the Director (Staff Manual Guide 1410.35), finds 
that Albert Poet has been convicted of a felony under Federal law for 
conduct relating to the regulation of a drug product under the FD&C 
Act.
    As a result of the foregoing finding, Dr. Poet is permanently 
debarred 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) (see DATES) (see 
sections 306(c)(1)(B) and (c)(2)(A)(ii), and 201(dd) of the FD&C Act 
(21 U.S.C. 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. Poet, in any capacity 
during Dr. Poet'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. Poet 
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. Poet 
during his period of debarment (section 306(c)(1)(B) of the FD&C Act).
    Any application by Dr. Poet for special termination of debarment 
under section 306(d)(4) of the FD&C Act should be identified with 
Docket No. FDA-2010-N-0478 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: February 16, 2011.
Howard Sklamberg,
Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2011-4778 Filed 3-2-11; 8:45 am]
BILLING CODE 4160-01-P

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