[Federal Register Volume 76, Number 122 (Friday, June 24, 2011)]
[Notices]
[Pages 37126-37127]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-15737]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0472]


Timothy J. Rosio: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is issuing an order 
under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring 
Timothy J. Rosio, M.D. for 4 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. Rosio was 
convicted of misdemeanors 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. Rosio was given notice of the proposed 
debarment and an opportunity to request a hearing within the timeframe 
prescribed by regulation. Dr. Rosio failed to respond. Dr. Rosio's 
failure to respond constitutes a waiver of his right to a hearing 
concerning this action.

DATES: This order is effective June 24, 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 (HFC-230), Food and Drug Administration, 5600 Fishers Lane, 
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 drug products 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 October 18, 2007, Dr. Rosio pleaded guilty to one count of 
receipt and delivery of a misbranded drug in violation of 21 U.S.C. 
331(c) and one count of misbranding of drugs held for sale in violation 
of 21 U.S.C. 331(k). On October 26, 2007, the U.S. District Court for 
the Eastern District of California entered judgment against Dr. Rosio 
for misdemeanor misbranding on those charges.
    FDA's finding that debarment is appropriate is based on the 
misdemeanor convictions referenced herein. The factual basis for the 
convictions is as follows: Dr. Rosio was a licensed physician in the 
State of California. Between on or about February 23, 2004, and on or 
about August 26, 2004, in the Eastern District of California, Dr. Rosio 
received Botulinum Toxin Type A (TRI-toxin) from Toxin Research 
International (TRI), which had been shipped in interstate commerce, 
from Arizona to his clinic in the Eastern District of California. The 
TRI-toxin that he received was misbranded in that it lacked adequate 
directions for use in humans. The drug was not approved for use in 
humans by FDA. After receiving the unapproved drug, Dr. Rosio proffered 
the delivery and caused the delivery of the drug to patients, some on 
multiple occasions, in the form of injections, for pay and otherwise, 
in violation of 21 U.S.C. 331(c). Dr. Rosio additionally held the drug 
for sale as BOTOX, the FDA approved Botulinum Toxin Type A product. In 
so doing, Dr. Rosio acted in a way that caused the drug to be further 
misbranded by offering it for sale to the public under the name of 
another drug, specifically BOTOX, in violation of 21 U.S.C. 331(k).
    As a result of his convictions, on February 16, 2011, FDA sent Dr. 
Rosio a notice by certified mail proposing to debar him for 4 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. 
Rosio was convicted of a misdemeanor under Federal law for conduct 
relating to the regulation of drug products under the FD&C Act, and 
that the conduct that served as a basis for the conviction undermines 
the process for the regulation of drugs. The proposal also offered Dr. 
Rosio 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. Rosio 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(b)(2)(B)(i)(I) of the FD& C Act 
under authority delegated to him (Staff Manual Guide 1410.35), finds 
that Timothy J. Rosio has

[[Page 37127]]

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. Rosio is debarred for 4 
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. 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. Rosio, 
in any capacity during Dr. Rosio'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. Rosio 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 (21 U.S.C. 335b(a)(7)). In addition, FDA will 
not accept or review any abbreviated new drug applications submitted by 
or with the assistance of Dr. Rosio during his period of debarment 
(section 306(c)(1)(B) of the FD&C Act).
    Any application by Dr. Rosio for termination of debarment under 
section 306(d)(1) of the FD&C Act should be identified with Docket No. 
FDA-2010-N-0472 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 13, 2011.
Howard Sklamberg,
Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2011-15737 Filed 6-23-11; 8:45 am]
BILLING CODE 4160-01-P