Stephen C. Delaney, Jr.: Debarment Order, 61003-61004 [2012-24528]

Download as PDF pmangrum on DSK3VPTVN1PROD with NOTICES Federal Register / Vol. 77, No. 194 / Friday, October 5, 2012 / Notices 31073, June 5, 2007. The changes are as follows: I. Under Chapter KA, Office of the Assistant Secretary, delete KA.00 Mission in its entirety and replace with the following: KA.00 MISSION. The Office of the Assistant Secretary for Children and Families (OAS) provides executive direction, leadership, and guidance for all ACF programs. OAS provides national leadership to develop and coordinate public and private initiatives for carrying out programs that promote permanency placement planning, family stability, and self-sufficiency. OAS advises the Secretary on issues affecting America’s children and families, including Native Americans, refugees, and legalized aliens. OAS provides leadership on human service issues and conducts emergency preparedness and response operations during a nationally declared emergency. II. 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It coordinates news media relations strategy; responds to all media inquiries concerning ACF programs and related issues; develops fact sheets, news releases, feature articles for magazines and other publications on ACF programs and initiatives; and manages preparation and clearance of speeches and official statements on ACF programs. It coordinates regional public affairs policies and public affairs activities pertaining to ACF programs and initiatives. The Office coordinates hotline calls received by the Office of Inspector General and the Government Accountability Office relating to ACF operations and personnel and assists the VerDate Mar<15>2010 15:25 Oct 04, 2012 Jkt 229001 ACF FOIA Officer in processing FOIA inquiries and requests relating to ACF programs and activities. Dated: September 21, 2012. George H. Sheldon, Acting Assistant Secretary for Children and Families. [FR Doc. 2012–24587 Filed 10–4–12; 8:45 am] BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0405] Stephen C. Delaney, Jr.: 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 Stephen C. Delaney, Jr. for a period of 5 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. Delaney was convicted of one felony count under Federal law for conduct relating to the importation into the United States of an article of food. Mr. Delaney was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of August 10, 2012 (30 days after receipt of the notice), Mr. Delaney had not responded. Mr. Delaney’s failure to respond constitutes a waiver of his right to a hearing concerning this action. DATES: This order is effective October 5, 2012. 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: SUMMARY: 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 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 61003 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 April 8, 2011, Mr. Delaney was convicted in the U.S. District Court for the District of Massachusetts of one count of false labeling under the Lacey Act in violation of 16 U.S.C. 3372(d). FDA’s finding that debarment is appropriate is based on the felony conviction referenced herein for conduct relating to the importation into the United States of any food. The factual basis for this conviction is as follows: As alleged in the indictment that was filed against Mr. Delaney, he was the president and owner of a seafood packing and re-packing company. On or about April 15, 2009, in violation of 16 U.S.C. 3372(d), he knowingly made and submitted a false record, account and label for, and a false identification of fish that had been and was intended to be, imported, purchased, and received from a foreign country and transported in interstate commerce, and involved the sale and purchase, the offer of sale and purchase, and the intent to sell and purchase, fish with a market value of approximately $8,000. Specifically, Mr. Delaney falsely labeled imported frozen fillets of pollock, product of China, as cod loins, product of Canada. As a result of his conviction, on July 9, 2012, FDA sent Mr. Delaney a notice by certified mail proposing to debar him for a period of 5 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. Delaney was convicted of a felony under Federal law for conduct relating to the importation into the United States of an article of food because he knowingly made and submitted a false record, account and label for, and a false identification of fish that had been and was intended to be, imported, purchased, and received from a foreign country and transported in interstate commerce, and involved the sale and purchase, the offer of sale and purchase, and intent to sell and purchase, fish with a market value of approximately $8,000. 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. Delaney should be subject to a 5year period of debarment. The proposal also offered Mr. Delaney 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 E:\FR\FM\05OCN1.SGM 05OCN1 61004 Federal Register / Vol. 77, No. 194 / Friday, October 5, 2012 / Notices him that failure to request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. Mr. Delaney 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). N–0405 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 Dated: September 21, 2012. Armando Zamora, Acting Director, Office of Enforcement, Office of Regulatory Affairs. Therefore, the Director, Office of Enforcement, Office of Regulatory Affairs, under section 306(b)(1)(C) of the FD&C Act, and under authority delegated to the Director (Staff Manual Guide 1410.35), finds that Mr. Stephen C. Delaney, Jr. has been convicted of a felony 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 5-year period of debarment. As a result of the foregoing finding, Mr. Delaney is debarred for a period of 5 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. Delaney is a prohibited act. Any application by Mr. Delaney for termination of debarment under section 306(d)(1) of the FD&C Act should be identified with Docket No. FDA–2012– [FR Doc. 2012–24528 Filed 10–4–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0001] Request for Nominations for Voting Members on Public Advisory Committees AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Allergenic Products Advisory Committee, Blood Products Advisory Committee, Cellular, Tissue and Gene Therapies Advisory SUMMARY: Committee, and Transmissible Spongiform and Encephalopathies Advisory Committee, Center for Biologics Evaluation and Research. Nominations will be accepted for vacancies that will or may occur through December 31, 2013. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore encourages nominations of appropriately qualified candidates from these groups. DATES: Because scheduled vacancies occur on various dates throughout each year, no cutoff date is established for the receipt of nominations. However, when possible, nominations should be received at least 6 months before the date of scheduled vacancies for each year, as indicated in this notice. ADDRESSES: All nominations for membership should be sent electronically to cv@oc.fda.gov, or by mail to Advisory Committee Oversight and Management Staff, 10903 New Hampshire Ave., Bldg. 32, rm. 5103, Silver Spring, MD 20993–0002. Information about becoming a member on a FDA advisory committee can also be obtained by visiting FDA’s Web site at https://www.fda.gov/ AdvisoryCommittees/default.htm. FOR FURTHER INFORMATION CONTACT: For specific Committee questions, contact the following persons listed in Table 1 of this document: TABLE 1 Contact person Committee Donald Jehn, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, HFM–71, Rockville, MD 20852, 301–827–1293; email: donald.jehn@fda.hhs.gov. Bryan Emery, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, HFM–71, Rockville, MD 20852, 301–827–1277, email: bryan.emery@fda.hhs.gov. Gail Dapolito, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, HFM–71, Rockville, MD 20852, 301–827–1289, email: gail.dapolito@fda.hhs.gov. Allergenic Products Advisory Committee. Blood Products Advisory Committee and Transmissible Spongiform Encephalopathies Advisory Committee. Cellular, Tissue and Gene Therapies Advisory Committee. I. Vacancies FDA is requesting nominations of voting members for vacancies listed as follows: SUPPLEMENTARY INFORMATION: pmangrum on DSK3VPTVN1PROD with NOTICES TABLE 2 Upcoming vacancies Committee expertise needed Approximate date needed 3 4 September 1, 2013. October 1, 2013. 2 April 2, 2013. Allergenic Products Advisory Committee—individuals knowledgeable in clinical immunology/allergy ...... Blood Products Advisory Committee—individuals knowledgeable in surgery/trauma, pediatric hematology/oncology, hematology, medical epidemiology. Cellular, Tissue and Gene Therapies Advisory Committee—individuals knowledgeable in tissue engineering/regenerative medicine, orthopedic oncology. VerDate Mar<15>2010 15:25 Oct 04, 2012 Jkt 229001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\05OCN1.SGM 05OCN1

Agencies

[Federal Register Volume 77, Number 194 (Friday, October 5, 2012)]
[Notices]
[Pages 61003-61004]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-24528]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0405]


Stephen C. Delaney, Jr.: 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 
Stephen C. Delaney, Jr. for a period of 5 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. Delaney was 
convicted of one felony count under Federal law for conduct relating to 
the importation into the United States of an article of food. Mr. 
Delaney was given notice of the proposed debarment and an opportunity 
to request a hearing within the timeframe prescribed by regulation. As 
of August 10, 2012 (30 days after receipt of the notice), Mr. Delaney 
had not responded. Mr. Delaney's failure to respond constitutes a 
waiver of his right to a hearing concerning this action.

DATES: This order is effective October 5, 2012.

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 April 8, 2011, Mr. Delaney was convicted in the U.S. District 
Court for the District of Massachusetts of one count of false labeling 
under the Lacey Act in violation of 16 U.S.C. 3372(d).
    FDA's finding that debarment is appropriate is based on the felony 
conviction referenced herein for conduct relating to the importation 
into the United States of any food. The factual basis for this 
conviction is as follows: As alleged in the indictment that was filed 
against Mr. Delaney, he was the president and owner of a seafood 
packing and re-packing company. On or about April 15, 2009, in 
violation of 16 U.S.C. 3372(d), he knowingly made and submitted a false 
record, account and label for, and a false identification of fish that 
had been and was intended to be, imported, purchased, and received from 
a foreign country and transported in interstate commerce, and involved 
the sale and purchase, the offer of sale and purchase, and the intent 
to sell and purchase, fish with a market value of approximately $8,000. 
Specifically, Mr. Delaney falsely labeled imported frozen fillets of 
pollock, product of China, as cod loins, product of Canada.
    As a result of his conviction, on July 9, 2012, FDA sent Mr. 
Delaney a notice by certified mail proposing to debar him for a period 
of 5 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. Delaney was 
convicted of a felony under Federal law for conduct relating to the 
importation into the United States of an article of food because he 
knowingly made and submitted a false record, account and label for, and 
a false identification of fish that had been and was intended to be, 
imported, purchased, and received from a foreign country and 
transported in interstate commerce, and involved the sale and purchase, 
the offer of sale and purchase, and intent to sell and purchase, fish 
with a market value of approximately $8,000.
    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. Delaney should be subject to a 5-year 
period of debarment. The proposal also offered Mr. Delaney 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

[[Page 61004]]

him that failure to request a hearing constituted a waiver of the 
opportunity for a hearing and of any contentions concerning this 
action. Mr. Delaney 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)(1)(C) of the FD&C Act, and 
under authority delegated to the Director (Staff Manual Guide 1410.35), 
finds that Mr. Stephen C. Delaney, Jr. has been convicted of a felony 
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 5-year 
period of debarment.
    As a result of the foregoing finding, Mr. Delaney is debarred for a 
period of 5 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. Delaney 
is a prohibited act.
    Any application by Mr. Delaney for termination of debarment under 
section 306(d)(1) of the FD&C Act should be identified with Docket No. 
FDA-2012-N-0405 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: September 21, 2012.
Armando Zamora,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2012-24528 Filed 10-4-12; 8:45 am]
BILLING CODE 4160-01-P

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