Albert Ronald Cioffi: Debarment Order, 66072-66073 [2011-27509]

Download as PDF sroberts on DSK5SPTVN1PROD with NOTICES 66072 Federal Register / Vol. 76, No. 206 / Tuesday, October 25, 2011 / Notices 34). Therefore, information to allow participation in the meeting through the Internet (to see the slides) and a teleconference call (capacity 50) will be provided to registered participants. Participants are encouraged to consider attending by this method. Each participant is requested to register for the free meeting by sending an e-mail to noracoordinator@cdc.gov containing the participant’s name, organization name, contact telephone number on the day of the meeting, and preference for participation by Web meeting (requirements include: computer, Internet connection, and telephone, preferably with ‘‘mute’’ capability) or in person. An e-mail confirming registration will include the details needed to participate in the Web meeting. Non-US citizens are encouraged to participate in the Web meeting. 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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0159] Albert Ronald Cioffi: Debarment Order [FR Doc. 2011–27627 Filed 10–24–11; 8:45 am] AGENCY: BILLING CODE 4163–19–P HHS. ACTION: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0084] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 3793. SUMMARY: On July 14, 2011, the Agency submitted a proposed collection of information entitled ‘‘Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals’’ 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 0910–0562. The approval expires on September 30, 2014. A copy of the supporting statement for this information collection is available on the Internet at https:// www.reginfo.gov/public/do/PRAMain. SUPPLEMENTARY INFORMATION: Dated: October 19, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–27532 Filed 10–24–11; 8:45 am] BILLING CODE 4160–01–P PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 Food and Drug Administration, Notice. The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Albert Cioffi, MD for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on findings that Dr. Cioffi was convicted of a misdemeanor under Federal law for conduct relating to the regulation of a drug product under the FD&C Act and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. Dr. Cioffi was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Cioffi failed to request a hearing. Dr. Cioffi’s failure to request a hearing constitutes a waiver of his right to a hearing concerning this action. DATES: This order is effective October 25, 2011. 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: Kenny Shade, Division of Compliance Policy, Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., rm. 4144, Rockville, MD 20857, 301–796– 4640. SUMMARY: SUPPLEMENTARY INFORMATION: I. Background Section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C. 335a(b)(2)(B)(i)(I)) permits FDA to debar an individual if it finds that the individual has been convicted of a misdemeanor under Federal law for conduct relating to the regulation of a drug product under the FD&C Act, and if FDA finds that the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs. On January 9, 2008, based upon a plea of guilty to one count of misbranding a drug while held for sale after shipment in interstate commerce, in violation of 21 U.S.C. 331(k), 333(a)(1), and E:\FR\FM\25OCN1.SGM 25OCN1 sroberts on DSK5SPTVN1PROD with NOTICES Federal Register / Vol. 76, No. 206 / Tuesday, October 25, 2011 / Notices 352(i)(3), judgment was entered against Dr. Cioffi in the United States District Court for the Southern District of Florida. FDA’s finding that debarment is appropriate is based on the misdemeanor conviction referenced herein. The factual basis for the conviction is as follows: During 2004, Dr. Cioffi was a physician licensed to practice in the State of Florida. In February 2004, Dr. Cioffi became the medical doctor of Body Rx, a medical office located in Boca Raton, FL. In July 2004, Dr. Cioffi became the sole owner of Body Rx which specialized in cosmetic procedures, including the treatment of forehead wrinkles. When Dr. Cioffi began working at Body Rx, he learned that Body Rx had been treating patients for forehead wrinkles with the unapproved drug derived from Botulinum Toxin Type A (TRI-toxin), sold by Toxin Research International (TRI), a company in Tuscon, AZ. Dr. Cioffi spoke with TRI representatives and learned that TRI-toxin was not approved by FDA for treatment of facial wrinkles. Nonetheless, Dr. Cioffi continued to purchase and use the unapproved drug from TRI. On four separate occasions between February and November of 2004, Body Rx purchased a total of eight vials of unapproved TRI-toxin at Dr. Cioffi’s direction. Dr. Cioffi used the unapproved drug to inject approximately 30 patients and never informed these patients that they were receiving an unapproved version of Botulinum Toxin Type A. Instead, Dr. Cioffi told patients that they were purchasing and being injected with the approved BOTOX Cosmetic, and he indicated in these patients’ medical records that they were receiving the FDA approved BOTOX Cosmetic. From in or about February 2004, and continuing through in or about November 2004, in the Southern District of Florida, and elsewhere, Dr. Cioffi did misbrand a drug, namely Botulinum Toxin Type A distributed by TRI, while it was held for sale and after shipment in interstate commerce, in that he offered the unapproved Botulinum Toxin Type A for sale by injection to patients under the name of another drug, all in violation of 21 U.S.C. 331(k), 333(a)(1), 352(i)(3), and 18 U.S.C. 2. As a result of his conviction, on June 1, 2011, FDA sent Dr. Cioffi a notice by certified mail proposing to debar him for 5 years 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(b)(2)(B)(i)(I) of the FD&C Act that Dr. Cioffi was VerDate Mar<15>2010 18:10 Oct 24, 2011 Jkt 226001 66073 convicted of a misdemeanor under Federal law for conduct relating to the regulation of a drug product under the FD&C Act, and the conduct that served as a basis for the conviction undermines the process for the regulation of drugs. The proposal also offered Dr. Cioffi 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. Cioffi failed to request a hearing 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). Any application by Dr. Cioffi for termination of debarment under section 306(d)(1) of the Act (21 U.S.C. 355a(d)(1)) should be identified with Docket No. FDA–2011–N–0159 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. II. Findings and Order BILLING CODE 4160–01–P Therefore, the Acting Director, Office of Enforcement, Office of Regulatory Affairs, under section 306(b)(2)(B)(i)(I) of the FD&C Act under authority delegated to him (Staff Manual Guide 1410.35), finds that Albert R. Cioffi has been convicted of a misdemeanor under Federal law for conduct relating to the regulation of a drug product under the FD&C Act, and that the type of conduct that served as a basis for the conviction undermines the process for the regulation of drugs. As a result of the foregoing finding, Dr. Cioffi is debarred for 5 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)(iii), and 201(dd) of the FD&C Act (21 U.S.C. 335a(c)(1)(B), (c)(2)(A)(iii), 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. Cioffi, in any capacity during Dr. Cioffi’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. Cioffi 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. Cioffi during his period of debarment (section 306(c)(1)(B) of the FD&C Act). PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 Dated: October 11, 2011. Armando Zamora, Acting Director, Office of Enforcement, Office of Regulatory Affairs. [FR Doc. 2011–27509 Filed 10–24–11; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–D–0643] Guidance for Industry on What You Need to Know About Administrative Detention of Foods; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘What You Need to Know About Administrative Detention of Foods.’’ This guidance provides information pertaining to FDA’s authority to order the administrative detention of food for human or animal consumption under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety and Modernization Act (FSMA). DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Outreach and Information Center (HFS– 009), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the SUMMARY: E:\FR\FM\25OCN1.SGM 25OCN1

Agencies

[Federal Register Volume 76, Number 206 (Tuesday, October 25, 2011)]
[Notices]
[Pages 66072-66073]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-27509]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0159]


Albert Ronald Cioffi: 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 
Albert Cioffi, MD for 5 years from providing services in any capacity 
to a person that has an approved or pending drug product application. 
FDA bases this order on findings that Dr. Cioffi was convicted of a 
misdemeanor under Federal law for conduct relating to the regulation of 
a drug product under the FD&C Act and that the type of conduct 
underlying the conviction undermines the process for the regulation of 
drugs. Dr. Cioffi was given notice of the proposed debarment and an 
opportunity to request a hearing within the timeframe prescribed by 
regulation. Dr. Cioffi failed to request a hearing. Dr. Cioffi's 
failure to request a hearing constitutes a waiver of his right to a 
hearing concerning this action.

DATES: This order is effective October 25, 2011.

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: Kenny Shade, Division of Compliance 
Policy, Food and Drug Administration, 12420 Parklawn Dr., Element 
Bldg., rm. 4144, Rockville, MD 20857, 301-796-4640.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C. 
335a(b)(2)(B)(i)(I)) permits FDA to debar an individual if it finds 
that the individual has been convicted of a misdemeanor under Federal 
law for conduct relating to the regulation of a drug product under the 
FD&C Act, and if FDA finds that the type of conduct that served as the 
basis for the conviction undermines the process for the regulation of 
drugs.
    On January 9, 2008, based upon a plea of guilty to one count of 
misbranding a drug while held for sale after shipment in interstate 
commerce, in violation of 21 U.S.C. 331(k), 333(a)(1), and

[[Page 66073]]

352(i)(3), judgment was entered against Dr. Cioffi in the United States 
District Court for the Southern District of Florida.
    FDA's finding that debarment is appropriate is based on the 
misdemeanor conviction referenced herein. The factual basis for the 
conviction is as follows: During 2004, Dr. Cioffi was a physician 
licensed to practice in the State of Florida. In February 2004, Dr. 
Cioffi became the medical doctor of Body Rx, a medical office located 
in Boca Raton, FL. In July 2004, Dr. Cioffi became the sole owner of 
Body Rx which specialized in cosmetic procedures, including the 
treatment of forehead wrinkles. When Dr. Cioffi began working at Body 
Rx, he learned that Body Rx had been treating patients for forehead 
wrinkles with the unapproved drug derived from Botulinum Toxin Type A 
(TRI-toxin), sold by Toxin Research International (TRI), a company in 
Tuscon, AZ. Dr. Cioffi spoke with TRI representatives and learned that 
TRI-toxin was not approved by FDA for treatment of facial wrinkles. 
Nonetheless, Dr. Cioffi continued to purchase and use the unapproved 
drug from TRI. On four separate occasions between February and November 
of 2004, Body Rx purchased a total of eight vials of unapproved TRI-
toxin at Dr. Cioffi's direction. Dr. Cioffi used the unapproved drug to 
inject approximately 30 patients and never informed these patients that 
they were receiving an unapproved version of Botulinum Toxin Type A. 
Instead, Dr. Cioffi told patients that they were purchasing and being 
injected with the approved BOTOX Cosmetic, and he indicated in these 
patients' medical records that they were receiving the FDA approved 
BOTOX Cosmetic.
    From in or about February 2004, and continuing through in or about 
November 2004, in the Southern District of Florida, and elsewhere, Dr. 
Cioffi did misbrand a drug, namely Botulinum Toxin Type A distributed 
by TRI, while it was held for sale and after shipment in interstate 
commerce, in that he offered the unapproved Botulinum Toxin Type A for 
sale by injection to patients under the name of another drug, all in 
violation of 21 U.S.C. 331(k), 333(a)(1), 352(i)(3), and 18 U.S.C. 2.
    As a result of his conviction, on June 1, 2011, FDA sent Dr. Cioffi 
a notice by certified mail proposing to debar him for 5 years 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(b)(2)(B)(i)(I) of the FD&C Act that Dr. Cioffi was 
convicted of a misdemeanor under Federal law for conduct relating to 
the regulation of a drug product under the FD&C Act, and the conduct 
that served as a basis for the conviction undermines the process for 
the regulation of drugs. The proposal also offered Dr. Cioffi 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. Cioffi failed to request a hearing 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 Acting Director, Office of Enforcement, Office of 
Regulatory Affairs, under section 306(b)(2)(B)(i)(I) of the FD&C Act 
under authority delegated to him (Staff Manual Guide 1410.35), finds 
that Albert R. Cioffi has been convicted of a misdemeanor under Federal 
law for conduct relating to the regulation of a drug product under the 
FD&C Act, and that the type of conduct that served as a basis for the 
conviction undermines the process for the regulation of drugs.
    As a result of the foregoing finding, Dr. Cioffi is debarred for 5 
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)(iii), and 201(dd) of the 
FD&C Act (21 U.S.C. 335a(c)(1)(B), (c)(2)(A)(iii), 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. Cioffi, in any capacity during Dr. 
Cioffi'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. Cioffi 
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. Cioffi 
during his period of debarment (section 306(c)(1)(B) of the FD&C Act).
    Any application by Dr. Cioffi for termination of debarment under 
section 306(d)(1) of the Act (21 U.S.C. 355a(d)(1)) should be 
identified with Docket No. FDA-2011-N-0159 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: October 11, 2011.
Armando Zamora,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2011-27509 Filed 10-24-11; 8:45 am]
BILLING CODE 4160-01-P

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