Richard Stowell: Debarment Order, 13068-13069 [2013-04389]

Download as PDF 13068 Federal Register / Vol. 78, No. 38 / Tuesday, February 26, 2013 / Notices were provided to subjects to participate in the study; (10) a description of how the sponsor(s) monitored the study and ensured that the study was carried out consistently with the study protocol; and (11) a description of how investigators were trained to comply with GCP and to conduct the study in accordance with the study protocol, and a statement on whether written commitments by investigators to comply with GCP and the protocol were obtained. Section 312.120(c) specifies how sponsors or applicants can request a waiver for any of the requirements under § 312.120(a)(1) and (b). Under § 312.120(c)(1), a waiver request must contain at least one of the following: (1) An explanation why the sponsor’s or applicant’s compliance with the requirement is unnecessary or cannot be achieved, (2) a description of an alternative submission or course of action that satisfies the purpose of the requirement, or (3) other information justifying a waiver. A waiver request may be submitted in an IND or in an information amendment to an IND, or in an application or in an amendment or supplement to an application submitted under 21 CFR part 314 or 601. Section 312.10 sets forth requirements for sponsors who request waivers from FDA for compliance with any of the provisions in part 312, and § 314.90 sets forth requirements for applicants who request waivers from FDA for compliance with §§ 314.50 through 314.81. FDA has approval for the submission of these waiver requests under OMB control numbers 0910–0014 for part 312 and 0910–0001 for part 314. In addition to the reporting requirements set forth in table 1 of this document, there is also a recordkeeping provision in § 312.120(d) stating how long sponsors and applicants must retain records required by § 312.120. In addition, § 312.120(b) states that any signed written commitments by investigators must be maintained by the sponsor or applicant and made available for Agency review upon request, and also specifies sponsor recordkeeping of IECrelated information. Under § 312.120(d), if a study is submitted in support of an application for marketing approval, records must be retained for 2 years after an Agency decision on that application; if a study is submitted in support of an IND but not an application for marketing approval, records must be retained for 2 years after the submission of the IND. The retention requirements in § 312.57(c) for records and reports required under part 312 apply to these provisions, and are approved under OMB control number 0910–0014. We estimate that 237 companies will submit a total of approximately 1,185 non-IND foreign clinical studies in support of an IND or application for marketing approval for a drug or biological product. Hour burden estimates vary due to differences in size, complexity, and duration across studies, and we estimate that complying with § 312.120 would take sponsors between 18 and 32 hours annually for each nonIND foreign clinical trial, totaling 37,920 hours (32 × 1,185). FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 21 CFR Section Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours 312.120 ................................................................................ 237 5 1,185 32 37,920 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: February 21, 2013. Leslie Kux, Assistant Commissioner for Policy. [Docket No. FDA–2012–N–0714] 335a(l)(1)(B)), of three felony counts under Federal law for conduct relating to the importation into the United States of an article of food. Mr. Stowell was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of December 14, 2012, Mr. Stowell had not responded. Mr. Stowell’s failure to respond constitutes a waiver of his right to a hearing concerning this action. Richard Stowell: Debarment Order DATES: [FR Doc. 2013–04422 Filed 2–25–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration AGENCY: Food and Drug Administration, tkelley on DSK3SPTVN1PROD with NOTICES 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. ADDRESSES: HHS. ACTION: This order is effective February 26, 2013. Notice. SUMMARY: The U.S. Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Richard Stowell for a period of 3 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. Stowell was convicted, as defined in section 306(l)(1)(B) of the FD&C Act (21 U.S.C. VerDate Mar<15>2010 16:35 Feb 25, 2013 Jkt 229001 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: PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 I. Background Section 306(b)(1)(C) of the FD&C Act (21 U.S.C. 335a(b)(1)(C)) permits FDA to debar an individual from importing an article of food or offering such an article for import into the United States if FDA finds, as required by section 306(b)(3)(A) of the FD&C Act (21 U.S.C. 335a(b)(3)(A)), that the individual has been convicted of a felony for conduct relating to the importation into the United States of any food. On July 27, 2011, Mr. Stowell was convicted, as defined in section 306(l)(1)(B) of the FD&C Act, when the U.S. District Court for the Southern District of Florida accepted his plea of guilty and entered judgment against him for the following offenses: One count of conspiracy to falsely label and misbrand seafood, in violation of 18 U.S.C. 371; one count of false labeling of seafood under the Lacey Act, in violation of 16 U.S.C. 3372(d)(2) and 3373(d)(3)(A)(ii); and one count of misbranding food, in violation of 21 U.S.C. 331(a), 343(a)(1), and 333(a)(2). FDA’s finding that debarment is appropriate is based on the felony E:\FR\FM\26FEN1.SGM 26FEN1 tkelley on DSK3SPTVN1PROD with NOTICES Federal Register / Vol. 78, No. 38 / Tuesday, February 26, 2013 / Notices convictions referenced herein for conduct relating to the importation into the United States of any food. The factual basis for these convictions is as follows: Mr. Stowell was the president and sole shareholder of United Seafood Imports, Inc. (United), a Florida based seafood wholesaler engaged in various aspects of purchasing, importing, processing, packing, selling, and exporting seafood products, including shrimp. Beginning in or around January 25, 2007, and continuing through on or about August 7, 2009, Mr. Stowell did knowingly and with the intent to further the object of a conspiracy combine, conspire, confederate, and agree with others to commit an offense against the United States. Specifically, Mr. Stowell’s company United purchased approximately one million pounds of shrimp in boxes labeled ‘‘Shrimp, Product of Thailand,’’ ‘‘Shrimp, Product of Malaysia,’’ and ‘‘Shrimp, Product of Indonesia.’’ Mr. Stowell then sent the shrimp to another company, Shifco, and instructed them to repackage and relabel the shrimp as ‘‘Shrimp, Product of Panama,’’ ‘‘Shrimp, Product of Ecuador,’’ and ‘‘Shrimp, Product of Honduras.’’ United, and employees under Mr. Stowell’s direction and control, managed and directed the labeling operations of Shifco by providing instructions and other directives to them. Mr. Stowell’s company then sold the shrimp that was relabeled to a company who in turn subsequently sold the shrimp to a supermarket chain. This was in violation of 18 U.S.C. 371. On or about January 26, 2007, Mr. Stowell purchased 180 cases of shrimp valued at approximately $24,912 and knowingly created and caused to be created individual labels, preprinted bags, and other documents falsely identifying the shrimp as being ‘‘Shrimp, Product of Ecuador,’’ when in truth and in fact he knew the shrimp was a product of Malaysia. This was in violation of 16 U.S.C. 3372(d)(2) and 3373(d)(3)(A)(ii). On or about July 2, 2009, Mr. Stowell knowingly engaged in an offense that involved the introduction and delivery for introduction into interstate commerce of a food that was misbranded, that is, approximately 52 cases of shrimp, with the intent to defraud or mislead, in that Mr. Stowell created and caused to be created individual labels, preprinted bags, and other documents falsely identifying the shrimp as being a product of Panama when in truth and in fact, he knew the shrimp was a product of Indonesia. This VerDate Mar<15>2010 16:35 Feb 25, 2013 Jkt 229001 was in violation of 21 U.S.C. 331(a), 333(a)(2), and 343(a)(1). As a result of his conviction, on September 24, 2012, FDA sent Mr. Stowell a notice by certified mail proposing to debar him for a period of 3 years from importing articles of food or offering such articles for import into the United States. The proposal was based on a finding under section 306(b)(1)(C) of the FD&C Act that Mr. Stowell was convicted of three felony counts under Federal law for conduct relating to the importation into the United States of an article of food because he: Conspired to falsely label and misbrand seafood, falsely labeled seafood under the Lacey Act, and misbranded food. The proposal was also based on a determination, after consideration of the factors set forth in section 306(c)(3) of the FD&C Act (21 U.S.C. 335a(c)(3)) that Mr. Stowell should be subject to a 3year period of debarment. The proposal also offered Mr. Stowell 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. Mr. Stowell 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 Associate Commissioner for Regulatory Affairs, Office of Regulatory Affairs, under section 306(b)(1)(C) of the FD&C Act, and under authority delegated to the Associate Commissioner (Staff Manual Guide 1410.21), finds that Mr. Richard Stowell has been convicted of three felony counts under Federal law for conduct relating to the importation of an article of food into the United States and that he is subject to a 3-year period of debarment. As a result of the foregoing finding, Mr. Stowell is debarred for a period of 3 years from importing articles of food or offering such articles for import into the United States, effective (see DATES). Pursuant to section 301(cc) of the FD&C Act (21 U.S.C. 331(cc)), the importing or offering for import into the United States of an article of food by, with the assistance of, or at the direction of Mr. Stowell is a prohibited act. Any application by Mr. Stowell for termination of debarment under section 306(d)(1) of the FD&C Act should be identified with Docket No. FDA–2012– PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 13069 N–0714 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 8, 2013. Melinda K. Plaisier, Acting Associate Commissioner for Regulatory Affairs, Office of Regulatory Affairs. [FR Doc. 2013–04389 Filed 2–25–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2003–D–0128] (formerly 2003D–0236) Draft Guidance for Industry: Recommendations for Screening, Testing, and, Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ‘‘Guidance for Industry: Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis,’’ dated March 2013. The draft guidance document provides revised recommendations for screening and testing of donors and management of donations based on screening tests for syphilis. The draft guidance is intended for blood establishments that collect Whole Blood or blood components, including Source Plasma. The guidance announced in this notice replaces the draft guidance entitled, ‘‘Guidance for Industry: Revised Recommendations for Donor and Product Management Based on Screening Tests for Syphilis,’’ dated June 2003. In addition, the draft guidance, when finalized, is intended to supersede the FDA memorandum to registered blood establishments dated December 12, 1991, entitled, ‘‘Clarification of FDA Recommendations for Donor Deferral and Product Distribution Based on the Results of Syphilis Testing.’’ E:\FR\FM\26FEN1.SGM 26FEN1

Agencies

[Federal Register Volume 78, Number 38 (Tuesday, February 26, 2013)]
[Notices]
[Pages 13068-13069]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04389]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0714]


Richard Stowell: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The U.S. Food and Drug Administration (FDA) is issuing an 
order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
debarring Richard Stowell for a period of 3 years from importing 
articles of food or offering such articles for importation into the 
United States. FDA bases this order on a finding that Mr. Stowell was 
convicted, as defined in section 306(l)(1)(B) of the FD&C Act (21 
U.S.C. 335a(l)(1)(B)), of three felony counts under Federal law for 
conduct relating to the importation into the United States of an 
article of food. Mr. Stowell was given notice of the proposed debarment 
and an opportunity to request a hearing within the timeframe prescribed 
by regulation. As of December 14, 2012, Mr. Stowell had not responded. 
Mr. Stowell's failure to respond constitutes a waiver of his right to a 
hearing concerning this action.

DATES: This order is effective February 26, 2013.

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, Office of Regulatory 
Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rockville, 
MD 20857, 301-796-4640.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(b)(1)(C) of the FD&C Act (21 U.S.C. 335a(b)(1)(C)) 
permits FDA to debar an individual from importing an article of food or 
offering such an article for import into the United States if FDA 
finds, as required by section 306(b)(3)(A) of the FD&C Act (21 U.S.C. 
335a(b)(3)(A)), that the individual has been convicted of a felony for 
conduct relating to the importation into the United States of any food.
    On July 27, 2011, Mr. Stowell was convicted, as defined in section 
306(l)(1)(B) of the FD&C Act, when the U.S. District Court for the 
Southern District of Florida accepted his plea of guilty and entered 
judgment against him for the following offenses: One count of 
conspiracy to falsely label and misbrand seafood, in violation of 18 
U.S.C. 371; one count of false labeling of seafood under the Lacey Act, 
in violation of 16 U.S.C. 3372(d)(2) and 3373(d)(3)(A)(ii); and one 
count of misbranding food, in violation of 21 U.S.C. 331(a), 343(a)(1), 
and 333(a)(2).
    FDA's finding that debarment is appropriate is based on the felony

[[Page 13069]]

convictions referenced herein for conduct relating to the importation 
into the United States of any food. The factual basis for these 
convictions is as follows: Mr. Stowell was the president and sole 
shareholder of United Seafood Imports, Inc. (United), a Florida based 
seafood wholesaler engaged in various aspects of purchasing, importing, 
processing, packing, selling, and exporting seafood products, including 
shrimp.
    Beginning in or around January 25, 2007, and continuing through on 
or about August 7, 2009, Mr. Stowell did knowingly and with the intent 
to further the object of a conspiracy combine, conspire, confederate, 
and agree with others to commit an offense against the United States. 
Specifically, Mr. Stowell's company United purchased approximately one 
million pounds of shrimp in boxes labeled ``Shrimp, Product of 
Thailand,'' ``Shrimp, Product of Malaysia,'' and ``Shrimp, Product of 
Indonesia.'' Mr. Stowell then sent the shrimp to another company, 
Shifco, and instructed them to repackage and relabel the shrimp as 
``Shrimp, Product of Panama,'' ``Shrimp, Product of Ecuador,'' and 
``Shrimp, Product of Honduras.'' United, and employees under Mr. 
Stowell's direction and control, managed and directed the labeling 
operations of Shifco by providing instructions and other directives to 
them. Mr. Stowell's company then sold the shrimp that was relabeled to 
a company who in turn subsequently sold the shrimp to a supermarket 
chain. This was in violation of 18 U.S.C. 371.
    On or about January 26, 2007, Mr. Stowell purchased 180 cases of 
shrimp valued at approximately $24,912 and knowingly created and caused 
to be created individual labels, preprinted bags, and other documents 
falsely identifying the shrimp as being ``Shrimp, Product of Ecuador,'' 
when in truth and in fact he knew the shrimp was a product of Malaysia. 
This was in violation of 16 U.S.C. 3372(d)(2) and 3373(d)(3)(A)(ii).
    On or about July 2, 2009, Mr. Stowell knowingly engaged in an 
offense that involved the introduction and delivery for introduction 
into interstate commerce of a food that was misbranded, that is, 
approximately 52 cases of shrimp, with the intent to defraud or 
mislead, in that Mr. Stowell created and caused to be created 
individual labels, preprinted bags, and other documents falsely 
identifying the shrimp as being a product of Panama when in truth and 
in fact, he knew the shrimp was a product of Indonesia. This was in 
violation of 21 U.S.C. 331(a), 333(a)(2), and 343(a)(1).
    As a result of his conviction, on September 24, 2012, FDA sent Mr. 
Stowell a notice by certified mail proposing to debar him for a period 
of 3 years from importing articles of food or offering such articles 
for import into the United States. The proposal was based on a finding 
under section 306(b)(1)(C) of the FD&C Act that Mr. Stowell was 
convicted of three felony counts under Federal law for conduct relating 
to the importation into the United States of an article of food because 
he: Conspired to falsely label and misbrand seafood, falsely labeled 
seafood under the Lacey Act, and misbranded food.
    The proposal was also based on a determination, after consideration 
of the factors set forth in section 306(c)(3) of the FD&C Act (21 
U.S.C. 335a(c)(3)) that Mr. Stowell should be subject to a 3-year 
period of debarment. The proposal also offered Mr. Stowell 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. Mr. Stowell 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 Associate Commissioner for Regulatory Affairs, 
Office of Regulatory Affairs, under section 306(b)(1)(C) of the FD&C 
Act, and under authority delegated to the Associate Commissioner (Staff 
Manual Guide 1410.21), finds that Mr. Richard Stowell has been 
convicted of three felony counts under Federal law for conduct relating 
to the importation of an article of food into the United States and 
that he is subject to a 3-year period of debarment.
    As a result of the foregoing finding, Mr. Stowell is debarred for a 
period of 3 years from importing articles of food or offering such 
articles for import into the United States, effective (see DATES). 
Pursuant to section 301(cc) of the FD&C Act (21 U.S.C. 331(cc)), the 
importing or offering for import into the United States of an article 
of food by, with the assistance of, or at the direction of Mr. Stowell 
is a prohibited act.
    Any application by Mr. Stowell for termination of debarment under 
section 306(d)(1) of the FD&C Act should be identified with Docket No. 
FDA-2012-N-0714 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 8, 2013.
Melinda K. Plaisier,
Acting Associate Commissioner for Regulatory Affairs, Office of 
Regulatory Affairs.
[FR Doc. 2013-04389 Filed 2-25-13; 8:45 am]
BILLING CODE 4160-01-P