[Federal Register Volume 85, Number 52 (Tuesday, March 17, 2020)]
[Notices]
[Pages 15195-15196]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05444]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-2734]


Robert Richard Jodoin: Final 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 (FD&C Act) debarring 
Robert Richard Jodoin for a period of 5 years from importing any drug 
into the United States. FDA bases this order on a finding that Mr. 
Jodoin was convicted, as defined in the FD&C Act, of one felony count 
under Federal law for unlawfully importing and attempting to import a 
controlled substance into the United States. The factual basis 
supporting the conviction, as described below, is conduct relating to 
the importation into the United States of a drug or controlled 
substance. Mr. Jodoin was given notice of the proposed debarment and, 
in accordance with the FD&C Act, was given an opportunity to request a 
hearing to show why he should not be debarred. As of November 9, 2019 
(30 days after receipt of the notice), Mr. Jodoin had not responded. 
Mr. Jodoin's failure to respond and request a hearing constitutes a 
waiver of his right to a hearing concerning this matter.

DATES: This order is applicable March 17, 2020.

ADDRESSES: Submit applications for termination of debarment to the 
Dockets Management Staff, Food and Drug Administration, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of 
Enforcement, Office of Strategic Planning and Operational Policy, 
Office of Regulatory Affairs, Food and Drug Administration, 12420 
Parklawn Dr., Rockville, MD 20857, 240-402-8743, or at, 
debarments@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(b)(1)(D) of the FD&C Act (21 U.S.C. 335a(b)(1)(D)) 
permits debarment of an individual from importing or offering for 
import any drug into the United States if FDA finds, as required by 
section 306(b)(3)(C) of the FD&C Act, that the individual has been 
convicted of a felony for conduct relating to the importation into the 
United States of any drug or controlled substance.
    On February 25, 2019, Mr. Jodoin was convicted as defined in 
section 306(l)(1)(B) of the FD&C Act, in the United States District 
Court for the Middle District of Florida, Jackson Division, when the 
court accepted his plea of guilty and entered judgment against him for 
multiple offenses, one of which is relevant to this debarment. 
Specifically, FDA's finding that debarment is appropriate is based on 
Mr. Jodoin's felony conviction for

[[Page 15196]]

knowingly and intentionally attempting to import into the United States 
a mixture and substance containing a detectable amount of gamma-
Hydroxybutyric Acid, a Schedule I controlled substance in violation of 
21 U.S.C. 952(a), 960(a)(1), 960(b)(3), and 963 on or about April 16, 
2018, as described in the Superseding Indictment in his case dated 
October 10, 2018.
    As a result of this conviction, FDA sent Mr. Jodoin by certified 
mail on September 25, 2019, a notice proposing to debar him for 5 years 
from importing or offering for import any drug into the United States. 
The proposal was based on a finding under section 306(b)(3)(C) of the 
FD&C Act that Mr. Jodoin's felony conviction was for conduct relating 
to the importation into the United States of any drug or controlled 
substance because he smuggled into the United States a Schedule I 
controlled substance. In proposing a debarment period, FDA weighed the 
considerations set forth in section 306(c)(3) of the FD&C Act that it 
considered applicable to Mr. Jodoin's offense and concluded Mr. 
Jodoin's felony offense warranted a 5-year period of debarment.
    The proposal informed Mr. Jodoin of the proposed debarment and 
offered Mr. Jodoin 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. Jodoin received the proposal and notice of 
opportunity for a hearing on October 8, 2019. Mr. Jodoin 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 Assistant Commissioner, Office of Human and Animal 
Food Operations, under section 306(b)(3)(C) of the FD&C Act, under 
authority delegated to the Assistant Commissioner, finds that Mr. 
Jodoin has been convicted of a felony under Federal law for conduct 
relating to the importation into the United States of any drug or 
controlled substance. FDA finds that this offense should be accorded a 
debarment period of 5 years.
    As a result of the foregoing finding, Mr. Jodoin is debarred for a 
period of 5 years from importing or offering for import any drug 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 any drug or controlled substance by, 
with the assistance of, or at the direction of Mr. Jodoin is a 
prohibited act.
    Any application by Mr. Jodoin for termination of debarment under 
section 306(d)(1) of the FD&C Act should be identified with Docket No. 
FDA-2019-N-2734 and sent to the Dockets Management Staff (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.
    Publicly available submissions will be placed in the docket and 
will be viewable at https://www.regulations.gov or at the Dockets 
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: March 11, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05444 Filed 3-16-20; 8:45 am]
BILLING CODE 4164-01-P


