89 FR 107 pgs. 47576-47578 - Michael Terry Little: Final Debarment Order
Type: NOTICEVolume: 89Number: 107Pages: 47576 - 47578
Pages: 47576, 47577, 47578Docket number: [Docket No. FDA-2023-N-5345]
FR document: [FR Doc. 2024-12066 Filed 5-31-24; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-5345]
Michael Terry Little: 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 Michael Terry Little 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. Little was convicted of one felony count under Federal law for introduction of unapproved new drugs in interstate commerce. The factual basis supporting Mr. Little's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Little 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 13, 2024 (30 days after receipt of the notice), Mr. Little had not responded. Mr. Little'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 June 3, 2024.
ADDRESSES:
Any application by Mr. Little for termination of debarment under section 306(d)(1) of the FD&C Act (21 U.S.C. 335a(d)(1)) may be submitted at any time as follows:
Electronic Submissions
[top] • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. An application submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your application will be made public, you are solely responsible for ensuring that your application does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or
• If you want to submit an application with confidential information that you do not wish to be made available to the public, submit the application as a written/paper submission and in the manner detailed (see "Written/Paper Submissions" and "Instructions").
Written/Paper Submissions
• Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For a written/paper application submitted to the Dockets Management Staff, FDA will post your application, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in "Instructions."
Instructions: All applications must include the Docket No. FDA-2023-N-5345. Received applications will be placed in the docket and, except for those submitted as "Confidential Submissions," publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
• Confidential Submissions-To submit an application with confidential information that you do not wish to be made publicly available, submit your application only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states "THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION." The Agency will review this copy, including the claimed confidential information, in its consideration of your application. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. Any information marked as "confidential" will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the "Search" box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. Publicly available submissions may be seen in the docket.
FOR FURTHER INFORMATION CONTACT:
Jaime Espinosa, Division of Compliance and Enforcement, Office of Policy, Compliance, and Enforcement, Office of Regulatory Affairs, Food and Drug Administration, 240-402-8743, or debarments@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(1)(D) of the FD&C Act 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 November 7, 2023, Mr. Little was convicted as defined in section 306(l)(1) of the FD&C Act, in the U. S. District Court for the District of Idaho when the court accepted his plea of guilty and entered judgment against him for the offense of Introduction of Unapproved New Drugs in Interstate Commerce in violation of 21 U.S.C. 331(d) and 333(a)(2) (sections 301(d) and 303(a)(2) of the FD&C Act). The underlying facts supporting the conviction are as follows: as charged in the Information and stated in the Plea Agreement, beginning in or about March 2018, and continuing to on or about January 2022, Mr. Little ran a business selling Selective Androgen Receptor Modulators (SARMs). SARMs are synthetic chemicals designed to mimic the effects of testosterone and other anabolic steroids. SARMs are new drugs under the FD&C Act that have not been reviewed by FDA for safety and effectiveness and have not been approved for marketing in the United States. Mr. Little primarily sold his SARM products via the website https://sarm.tech, under the name SARMTECH. Mr. Little imported the bulk ingredients from China which he then processed at his business location in Idaho. At Mr. Little's business location he used the imported bulk ingredients to manufacture the SARM products and he encapsulated, bottled, and prepared the products for shipment to his customers. To avoid government seizures of SARMs shipped to other countries, Mr. Little offered a stealth shipping option for an additional fee that intentionally mispackaged and falsely declared SARMs shipments as vitamins and supplements. Mr. Little sold at least $4,499,197.46 worth of SARMs between March 2018 and January 2022.
FDA sent Mr. Little, by certified mail, on February 5, 2024, 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. Little's felony conviction under Federal law for Introduction of Unapproved New Drugs in Interstate Commerce in violation of 21 U.S.C. 331(d) and 333(a)(2), was for conduct relating to the importation of any drug or controlled substance into the United States because Mr. Little illegally imported bulk ingredients for SARMs from China which he used as components to manufacture unapproved new drugs that he then distributed for sale to his customers. 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. Little's offense and concluded that the offense warranted the imposition of a 5-year period of debarment.
The proposal informed Mr. Little 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. Mr. Little received the proposal and notice of opportunity for a hearing on February 12, 2024. Mr. Little 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
[top] 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. Michael Terry Little 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
As a result of the foregoing finding, Mr. Little 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, the importing or offering for import into the United States of any drug by, with the assistance of, or at the direction of Mr. Little is a prohibited act.
Dated: May 29, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-12066 Filed 5-31-24; 8:45 am]
BILLING CODE 4164-01-P