Notice2022-10505
Howard Stanley Head, Jr.: Final Debarment Order
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 17, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Howard Stanley Head, Jr. for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Head was convicted of one felony count under Federal law for conspiracy to import misbranded prescription drugs. The factual basis supporting Mr. Head's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Head was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of March 24, 2022 (30 days after receipt of the notice), Mr. Head had not responded. Mr. Head's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 95 (Tuesday, May 17, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 95 (Tuesday, May 17, 2022)]
[Notices]
[Pages 29867-29868]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-10505]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-1226]
Howard Stanley Head, Jr.: Final 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 (FD&C Act) debarring
Howard Stanley Head, Jr. for a period of 5 years from importing or
offering for import any drug into the United States. FDA bases this
order on a finding that Mr. Head was convicted of one felony count
under Federal law for conspiracy to import misbranded prescription
drugs. The factual basis supporting Mr. Head's conviction, as described
below, is conduct relating to the importation into the United States of
a drug or controlled substance. Mr. Head was given notice of the
proposed debarment and was given an opportunity to request a hearing to
show why he should not be debarred. As of March 24, 2022 (30 days after
receipt of the notice), Mr. Head had not responded. Mr. Head'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 May 17, 2022.
ADDRESSES: Submit applications for termination of debarment to the
Dockets Management Staff, Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, or at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of
Enforcement (ELEM-4029), 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
<a href="/cdn-cgi/l/email-protection#88ecedeae9fae5ede6fcfbc8eeece9a6e0e0fba6efe7fe"><span class="__cf_email__" data-cfemail="e185848380938c848f9592a1878580cf898992cf868e97">[email protected]</span></a>.
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.
[[Page 29868]]
On November 2, 2021, Mr. Head was convicted, as defined in section
306(l)(1) of FD&C Act, in the U.S. District Court for the Eastern
District of Kentucky-Central Division of Frankfort, when the court
entered judgment against him for the offense of conspiracy to import
misbranded prescription drugs, in violation of 18 U.S.C. 371. FDA's
finding that debarment is appropriate is based on the felony conviction
referenced herein. The factual basis for this conviction is as follows:
As contained in the indictment, filed on November 5, 2020, and in
the plea agreement in Mr. Head's case, filed June 10, 2021, in or about
June 2015 and continuing through October 2019, Mr. Head conducted a
business under the name ``Dr. Head's Meds.'' In conducting this
business, on multiple occasions Mr. Head purchased thousands of generic
medication tablets for erectile dysfunction from overseas suppliers
located in countries such as India and Singapore. At his request, these
suppliers sent packages containing generic versions of VIAGRA and
CIALIS to Mr. Head's residence and other locations via the U.S. Postal
Service. The labeling accompanying these packages described their
contents in an inaccurate or misleading manner, such as ``Supplement.''
After receiving the bulk shipments of generic erectile dysfunction
tablets, Mr. Head sold them in smaller quantities to customers in the
United States.
As a result of this conviction, FDA sent Mr. Head, by certified
mail, on January 21, 2022, a notice proposing to debar him for a 5-year
period 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. Head's felony conviction under Federal law for
conspiracy to import misbranded prescription drugs, in violation of 18
U.S.C. 371, was for conduct relating to the importation into the United
States of any drug or controlled substance because he illegally
imported and introduced misbranded prescription drug products into
interstate commerce. 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. Head's offense and concluded that the
offense warranted the imposition of a 5-year period of debarment.
The proposal informed Mr. Head of the proposed debarment and
offered him 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. U.S. Postal Service records indicate that after a delivery
attempt to Mr. Head's residence was made and a notice left, the
proposal and notice of opportunity for a hearing letter was picked up
at his local post office on February 22, 2022. Mr. Head 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.
Howard Stanley Head, Jr. 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 the offense should be
accorded a debarment period of 5 years as provided by section
306(c)(2)(A)(iii) of the FD&C Act.
As a result of the foregoing finding, Mr. Head is debarred for a
period of five 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. Head is a
prohibited act.
Any application by Mr. Head for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2021-N-1226 and sent to the Dockets Management Staff (see
ADDRESSSES). The public availability of information in these
submissions is governed by 21 CFR 10.20(j).
Publicly available submissions will be placed in the docket and
will be viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday, 240-402-7500.
Dated: May 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-10505 Filed 5-16-22; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on May 17, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.