Timothy J. Rosio: Debarment Order, 37126-37127 [2011-15737]

Download as PDF 37126 Federal Register / Vol. 76, No. 122 / Friday, June 24, 2011 / Notices TABLE 2—ESTIMATED RECORDKEEPING BURDEN 1—Continued Number of recordkeepers Annual frequency per recordkeeping Total annual records Hours per record Total hours 500 1 500 8 4,000 ........................ ........................ ........................ ........................ 258,000 Maintain records to identify what reports have been stored and when the reporting process was restored ................ Total .............................................................................. 1 There are no capital costs or operating and maintenance costs associated with this information collection. V. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm, https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm, https://www.fda.gov/Food/Guidance ComplianceRegulatoryInformation/ GuidanceDocuments/default.htm, or https://www.regulations.gov. 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: Dated: June 20, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. 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 [FR Doc. 2011–15799 Filed 6–23–11; 8:45 am] BILLING CODE 4160–01–P 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. 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 srobinson on DSK4SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 19:06 Jun 23, 2011 Jkt 223001 PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 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 E:\FR\FM\24JNN1.SGM 24JNN1 Federal Register / Vol. 76, No. 122 / Friday, June 24, 2011 / Notices srobinson on DSK4SPTVN1PROD with NOTICES 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 VerDate Mar<15>2010 19:06 Jun 23, 2011 Jkt 223001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–E–0092] Determination of Regulatory Review Period for Purposes of Patent Extension; XYZAL AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined the regulatory review period for XYZAL and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product. ADDRESSES: Submit electronic comments to https:// www.regulations.gov. Submit written petitions along with three copies and written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6222, Silver Spring, MD 20993– 0002, 301–796–3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100–670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product’s regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory SUMMARY: PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 37127 review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA’s determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for marketing the human drug product XYZAL (levocetirizine dihydrochloride). XYZAL is indicated for the relief of symptoms associated with seasonal and perennial allergic rhinitis, and the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for XYZAL (U.S. Patent No. 5,698,558) from UCB Inc., and the Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration and that FDA determine the product’s regulatory review period. In a letter dated June 1, 2011, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of XYZAL represented the first permitted commercial marketing or use of the product. FDA has determined that the applicable regulatory review period for XYZAL is 305 days. Of this time, 0 days occurred during the testing phase of the regulatory review period, while 305 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became effective: FDA has verified the applicant’s claim that no investigational new drug application was submitted. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: July 25, 2006. The applicant claims July 24, 2006, as the date the new drug application (NDA) for Xyzal (NDA 22–064) was initially submitted. However, FDA records indicate that NDA 22–064 was submitted on July 25, 2006. 3. The date the application was approved: May 25, 2007. FDA has verified the applicant’s claim that NDA 22–064 was approved on May 25, 2007. This determination of the regulatory review period establishes the maximum potential length of a patent extension. E:\FR\FM\24JNN1.SGM 24JNN1

Agencies

[Federal Register Volume 76, Number 122 (Friday, June 24, 2011)]
[Notices]
[Pages 37126-37127]
From the Federal Register Online via the Government Printing 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.

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

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

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