[Federal Register Volume 83, Number 12 (Thursday, January 18, 2018)]
[Notices]
[Pages 2641-2642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00719]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0890]


William Ralph Kincaid; Denial of Hearing; Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
denying William Ralph Kincaid's (Kincaid's) request for a hearing and 
is issuing an order under the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) permanently debarring Kincaid from providing services in any 
capacity to a person that has an approved or pending drug product 
application. FDA bases this order on a finding that Kincaid was 
convicted of a felony under Federal law for conduct relating to the 
regulation of a drug product under the FD&C Act. Kincaid was given 
notice of the proposed debarment and an opportunity to request a 
hearing within the timeframe prescribed by regulation. Kincaid 
submitted a request for hearing but failed to file with the Agency 
information and analysis sufficient to create a basis for a hearing.

DATES: This order is applicable January 18, 2018.

ADDRESSES: Any application by Kincaid for special termination of 
debarment under section 306(d) of the FD&C Act (application) may be 
submitted as follows:

Electronic Submissions

     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 anyone else's Social Security number, 
or confidential business information, such as a manufacturing process. 
Please note that if you include your name, contact information, or 
other information that identifies you in the body of your application, 
that information will be posted on https://www.regulations.gov.
     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

    Submit written/paper submissions as follows:
     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: Your application must include the Docket No. FDA-
2015-N-0890. An application will be placed in the docket and, unless 
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.

[[Page 2642]]

     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. If you do not wish your name and contact information to be made 
publicly available, you can provide this information on the cover sheet 
and not in the body of your application and you must identify this 
information as ``confidential.'' 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.gpo.gov/fdsys/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. Publicly 
available submissions may be seen in the docket.

FOR FURTHER INFORMATION CONTACT: Julie Finegan, Office of Scientific 
Integrity, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 1, Rm. 4218, Silver Spring, MD 20993, 301-796-8618.

SUPPLEMENTARY INFORMATION: 

I. Background

    On June 24, 2013, the U. S. District Court for the Eastern District 
of Tennessee entered a criminal judgment against William Ralph Kincaid 
pursuant to his guilty plea. Kincaid pled guilty to a felony under the 
FD&C Act, namely receiving in interstate commerce a misbranded drug 
with intent to defraud or mislead, in violation of sections 301(c) and 
303(a)(2) of the FD&C Act (21 U.S.C. 331(c) and 333(a)(2)) and 18 
U.S.C. 2. The basis for this conviction was Kincaid's admission that he 
obtained drugs from Quality Specialty Products (QSP), a foreign 
company, for use at East Tennessee Hematology-Oncology Associates, P.C. 
(McLeod Cancer). These drugs were not FDA approved and were misbranded 
in that they lacked adequate directions for use and were manufactured 
in an establishment that was not registered with FDA and that did not 
list with FDA the drug products it manufactured. From approximately 
September 2007 to early 2008 and from August 2009 to February 2012, 
McLeod Cancer purchased more than $2 million in misbranded unapproved 
drugs for use at McLeod Cancer. Additionally, Kincaid and McLeod Cancer 
billed Medicare, TennCare, and other government health benefit programs 
approximately $2.5 million for these unapproved drugs.
    Kincaid is subject to debarment based on a finding, under section 
306(a)(2) of the FD&C Act (21 U.S.C. 335a(a)(2)), that he was convicted 
of a felony under Federal law for conduct relating to the regulation of 
a drug product under the FD&C Act. By the letter dated May 20, 2015, 
FDA notified Kincaid of a proposal to permanently debar him from 
providing services in any capacity to a person having an approved or 
pending drug product application. The proposal also offered Kincaid 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 60 days from 
the date of receipt of the letter to support that request with 
information sufficient to justify a hearing. In a letter dated June 17, 
2015, Kincaid requested a hearing and indicated that the information 
justifying the hearing would be forthcoming. More than 60 days have 
passed from the date Kincaid received FDA's letter, and Kincaid has not 
filed any additional information to support his request.
    Under the authority delegated to him by the Commissioner of Food 
and Drugs, the Director of the Office of Scientific Integrity (OSI) has 
considered Kincaid's request for a hearing. Hearings will not be 
granted on issues of policy or law, on mere allegations, denials, or 
general descriptions of positions and contentions, or on data and 
information insufficient to justify the factual determination urged 
(see 21 CFR 21.24(b)).
    Because Kincaid has not presented any information to support his 
hearing request, OSI concludes that Kincaid failed to raise a genuine 
and substantial issue of fact requiring a hearing. Therefore, OSI 
denies Kincaid's request for a hearing.

II. Findings and Order

    Therefore, OSI, under section 306(a)(2) of the FD&C Act and under 
the authority delegated, finds that William Ralph Kincaid has been 
convicted of a felony under Federal law for conduct relating to the 
regulation of a drug product under the FD&C Act.
    As a result of the foregoing findings, William Ralph Kincaid is 
permanently debarred from providing services in any capacity to a 
person with an approved or pending drug product application under 
section 505, 512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), 
or under section 351 of the Public Health Service Act (42 U.S.C. 262), 
effective (see DATES) (21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(ii) and 21 
U.S.C. 321(dd)). Any person with an approved or pending drug product 
application who knowingly uses the services of Kincaid, in any capacity 
during his period of debarment, will be subject to civil money 
penalties. See section 307(a)(6) of the FD&C Act (21 U.S.C. 
335b(a)(6)). If Kincaid, during his period of debarment, provides 
services in any capacity to a person with an approved or pending drug 
product application, he will be subject to civil money penalties. See 
section 307(a)(7) of the FD&C Act (21 U.S.C. 335b(a)(7)). In addition, 
FDA will not accept or review any abbreviated new drug applications 
submitted by or with the assistance of Kincaid during his period of 
debarment.

    Dated: January 10, 2018.
G. Matthew Warren,
Director, Office of Scientific Integrity.
[FR Doc. 2018-00719 Filed 1-17-18; 8:45 am]
 BILLING CODE 4164-01-P