[Federal Register Volume 87, Number 95 (Tuesday, May 17, 2022)]
[Notices]
[Pages 29867-29868]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-10505]


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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.

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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 
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 https://www.regulations.gov.

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 
[email protected].

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 https://www.regulations.gov 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]
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