[Federal Register Volume 77, Number 194 (Friday, October 5, 2012)]
[Notices]
[Pages 61003-61004]
From the Federal Register Online via the Government Publishing 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.

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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 
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