83 FR 2641 - William Ralph Kincaid; Denial of Hearing; Final Debarment Order
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 12 (January 18, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 12 (January 18, 2018)
| Page Range | 2641-2642 | |
| FR Document | 2018-00719 |
[Federal Register Volume 83, Number 12 (Thursday, January 18, 2018)] [Notices] [Pages 2641-2642] From the Federal Register Online [www.thefederalregister.org] [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 SubmissionsFederal 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.thefederalregister.org/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
![Federal Register / Vol. 83, No. 12 / Thursday, January 18, 2018 / Notices 2641
circular. If an alternative standard is B. Public Comment the timeframe prescribed by regulation.
proposed, the offeror must furnish data A 60 day notice was published in the Kincaid submitted a request for hearing
and/or information regarding the Federal Register at 82 FR 51256, on but failed to file with the Agency
alternative in sufficient detail for the November 3, 2017. One comment was information and analysis sufficient to
Government to determine if it meets the received; however, it was not create a basis for a hearing.
Government’s requirements. substantive, and did not change the DATES: This order is applicable January
We believe the burden for FAR estimate of the burden. 18, 2018.
52.211–7 to be negative, as it is purely ADDRESSES: Any application by Kincaid
C. Annual Reporting Burden
a permissive means for offerors to for special termination of debarment
propose reducing regulatory burden on Respondents: 100. under section 306(d) of the FD&C Act
a given solicitation. There are other Responses per Respondent: 1. (application) may be submitted as
places A–119 has an effect, though we Total Responses: 100. follows:
believe these to be positive. One is by Hours per Response: 1.
Total Burden Hours: 100. Electronic Submissions
enabling the single process initiative.
Another is the general replacement of Affected Public: Businesses or other • Federal eRulemaking Portal:
Mil standards with commercial for-profit and not-for-profit. https://www.regulations.gov. Follow the
standards, e.g., ISO 9000. Also, A–119 is Respondent’s Obligation: Required to instructions for submitting comments.
the basis for the language in FAR obtain or retain benefits. An application submitted electronically,
53.105, which reduces the chaos in data Reporting Frequency: On occasion. including attachments, to https://
standards development. The whole Obtaining Copies of Proposals: www.regulations.gov will be posted to
purpose of A–119 was to reduce Requesters may obtain a copy of the the docket unchanged. Because your
regulatory burden by promoting the use information collection documents from application will be made public, you are
of industry standards in lieu of federal the General Services Administration, solely responsible for ensuring that your
ones. Regulatory Secretariat Division (MVCB), application does not include any
1800 F Street NW, Washington, DC confidential information that you or a
To the extent that the data on the 20405, telephone 202–501–4755. Please third party may not wish to be posted,
annual frequency of the use of voluntary cite OMB Control No. 9000–0153, OMB such as medical information, your or
consensus standards under FAR 52.211– Circular A–119, in all correspondence. anyone else’s Social Security number, or
7 is not available, we believe 100 is confidential business information, such
Dated: January 12, 2018.
reasonable. As an aside, FAR part 45 as a manufacturing process. Please note
recognizes the use of voluntary Lorin S. Curit,
Director, Federal Acquisition Policy Division, that if you include your name, contact
consensus standards in the management information, or other information that
of Government property. However, in Office of Government-wide Acquisition
Policy, Office of Acquisition Policy, Office identifies you in the body of your
these cases, there is no Government application, that information will be
of Government-wide Policy.
standard per se, with the voluntary posted on https://www.regulations.gov.
[FR Doc. 2018–00779 Filed 1–17–18; 8:45 am]
consensus standard serving as the • If you want to submit an
BILLING CODE 6820–EP–P
Government standard. Consequently, application with confidential
when under part 45 voluntary information that you do not wish to be
consensus standards are used, they are made available to the public, submit the
not an alternative to a Government DEPARTMENT OF HEALTH AND
HUMAN SERVICES application as a written/paper
standard under FAR 52.211–7. submission and in the manner detailed
This collection implements OMB Food and Drug Administration (see ‘‘Written/Paper Submissions’’ and
Circular A–119, Federal Participation in ‘‘Instructions’’).
the Development and Use of Voluntary [Docket No. FDA–2015–N–0890]
Consensus Standards. FAR solicitation Written/Paper Submissions
William Ralph Kincaid; Denial of
provision 52.211–7, Alternatives to Submit written/paper submissions as
Hearing; Final Debarment Order
Government-Unique Standards, is the follows:
collection instrument. We have AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for
previously indicated that ‘‘to the extent HHS. written/paper submissions): Dockets
that the data on the annual frequency of ACTION: Notice. Management Staff (HFA–305), Food and
the use of voluntary consensus Drug Administration, 5630 Fishers
standards under FAR 52.211–7 is not SUMMARY: The Food and Drug Lane, Rm. 1061, Rockville, MD 20852.
available, we believe that 100 is Administration (FDA or the Agency) is • For a written/paper application
reasonable.’’ This is the number that has denying William Ralph Kincaid’s submitted to the Dockets Management
been reported since the inception of this (Kincaid’s) request for a hearing and is Staff, FDA will post your application, as
PRA collection, which indicates that issuing an order under the Federal well as any attachments, except for
revised data has been consistently Food, Drug, and Cosmetic Act (FD&C information submitted, marked and
unavailable since responses are Act) permanently debarring Kincaid identified, as confidential, if submitted
provided to contracting personnel at the from providing services in any capacity as detailed in ‘‘Instructions.’’
local level in response to a local to a person that has an approved or Instructions: Your application must
solicitation. We checked the FPDS data pending drug product application. FDA include the Docket No. FDA–2015–N–
sradovich on DSK3GMQ082PROD with NOTICES
dictionary and there are no codes to flag bases this order on a finding that 0890. An application will be placed in
data fields or provide a count of when Kincaid was convicted of a felony under the docket and, unless submitted as
Mil standards are used in solicitations/ Federal law for conduct relating to the ‘‘Confidential Submissions,’’ publicly
contracts. Considering the lack of FPDS regulation of a drug product under the viewable at https://www.regulations.gov
or other data, we recommend FD&C Act. Kincaid was given notice of or at the Dockets Management Staff
continuing the PRA coverage at the the proposed debarment and an between 9 a.m. and 4 p.m., Monday
current level. opportunity to request a hearing within through Friday.
VerDate Sep<11>2014 18:27 Jan 17, 2018 Jkt 244001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\18JAN1.SGM 18JAN1](https://thefederalregister.org/doc/83_FR_2653/page/1.svg)
![2642 Federal Register / Vol. 83, No. 12 / Thursday, January 18, 2018 / Notices
• Confidential Submissions—To was Kincaid’s admission that he II. Findings and Order
submit an application with confidential obtained drugs from Quality Specialty Therefore, OSI, under section
information that you do not wish to be Products (QSP), a foreign company, for 306(a)(2) of the FD&C Act and under the
made publicly available, submit your use at East Tennessee Hematology- authority delegated, finds that William
application only as a written/paper Oncology Associates, P.C. (McLeod Ralph Kincaid has been convicted of a
submission. You should submit two Cancer). These drugs were not FDA felony under Federal law for conduct
copies total. One copy will include the approved and were misbranded in that relating to the regulation of a drug
information you claim to be confidential they lacked adequate directions for use product under the FD&C Act.
with a heading or cover note that states and were manufactured in an As a result of the foregoing findings,
‘‘THIS DOCUMENT CONTAINS establishment that was not registered William Ralph Kincaid is permanently
CONFIDENTIAL INFORMATION.’’ The with FDA and that did not list with FDA debarred from providing services in any
Agency will review this copy, including the drug products it manufactured. capacity to a person with an approved
the claimed confidential information, in From approximately September 2007 to or pending drug product application
its consideration of your application. early 2008 and from August 2009 to under section 505, 512, or 802 of the
The second copy, which will have the February 2012, McLeod Cancer FD&C Act (21 U.S.C. 355, 360b, or 382),
claimed confidential information purchased more than $2 million in or under section 351 of the Public
redacted/blacked out, will be available misbranded unapproved drugs for use at Health Service Act (42 U.S.C. 262),
for public viewing and posted on McLeod Cancer. Additionally, Kincaid effective (see DATES) (21 U.S.C.
https://www.regulations.gov. Submit and McLeod Cancer billed Medicare, 335a(c)(1)(B) and (c)(2)(A)(ii) and 21
both copies to the Dockets Management TennCare, and other government health U.S.C. 321(dd)). Any person with an
Staff. If you do not wish your name and benefit programs approximately $2.5 approved or pending drug product
contact information to be made publicly million for these unapproved drugs. application who knowingly uses the
available, you can provide this Kincaid is subject to debarment based services of Kincaid, in any capacity
information on the cover sheet and not on a finding, under section 306(a)(2) of during his period of debarment, will be
in the body of your application and you the FD&C Act (21 U.S.C. 335a(a)(2)), that subject to civil money penalties. See
must identify this information as he was convicted of a felony under section 307(a)(6) of the FD&C Act (21
‘‘confidential.’’ Any information marked Federal law for conduct relating to the U.S.C. 335b(a)(6)). If Kincaid, during his
as ‘‘confidential’’ will not be disclosed regulation of a drug product under the period of debarment, provides services
except in accordance with 21 CFR 10.20 FD&C Act. By the letter dated May 20, in any capacity to a person with an
and other applicable disclosure law. For 2015, FDA notified Kincaid of a approved or pending drug product
more information about FDA’s posting proposal to permanently debar him from application, he will be subject to civil
of comments to public dockets, see 80 providing services in any capacity to a money penalties. See section 307(a)(7)
FR 56469, September 18, 2015, or access person having an approved or pending of the FD&C Act (21 U.S.C. 335b(a)(7)).
the information at: https://www.gpo.gov/ drug product application. The proposal In addition, FDA will not accept or
fdsys/pkg/FR-2015-09-18/pdf/2015- also offered Kincaid an opportunity to review any abbreviated new drug
23389.pdf. request a hearing, providing him 30 applications submitted by or with the
Docket: For access to the docket, go to days from the date of receipt of the letter assistance of Kincaid during his period
https://www.regulations.gov and insert in which to file the request and 60 days of debarment.
the docket number, found in brackets in from the date of receipt of the letter to
the heading of this document, into the support that request with information Dated: January 10, 2018.
‘‘Search’’ box and follow the prompts sufficient to justify a hearing. In a letter G. Matthew Warren,
and/or go to the Dockets Management dated June 17, 2015, Kincaid requested Director, Office of Scientific Integrity.
Staff, 5630 Fishers Lane, Rm. 1061, a hearing and indicated that the [FR Doc. 2018–00719 Filed 1–17–18; 8:45 am]
Rockville, MD 20852 between 9 a.m. information justifying the hearing BILLING CODE 4164–01–P
and 4 p.m., Monday through Friday. would be forthcoming. More than 60
Publicly available submissions may be days have passed from the date Kincaid
seen in the docket. received FDA’s letter, and Kincaid has DEPARTMENT OF HEALTH AND
FOR FURTHER INFORMATION CONTACT: Julie not filed any additional information to HUMAN SERVICES
Finegan, Office of Scientific Integrity, support his request.
Food and Drug Administration, 10903 Under the authority delegated to him Office of the Secretary
New Hampshire Ave., Bldg. 1, Rm. by the Commissioner of Food and Annual Update of the HHS Poverty
4218, Silver Spring, MD 20993, 301– Drugs, the Director of the Office of Guidelines
796–8618. Scientific Integrity (OSI) has considered
SUPPLEMENTARY INFORMATION: Kincaid’s request for a hearing. Hearings AGENCY: Department of Health and
will not be granted on issues of policy Human Services.
I. Background or law, on mere allegations, denials, or ACTION: Notice.
On June 24, 2013, the U. S. District general descriptions of positions and
Court for the Eastern District of contentions, or on data and information SUMMARY: This notice provides an
Tennessee entered a criminal judgment insufficient to justify the factual update of the Department of Health and
against William Ralph Kincaid pursuant determination urged (see 21 CFR Human Services (HHS) poverty
to his guilty plea. Kincaid pled guilty to 21.24(b)). guidelines to account for last calendar
sradovich on DSK3GMQ082PROD with NOTICES
a felony under the FD&C Act, namely Because Kincaid has not presented year’s increase in prices as measured by
receiving in interstate commerce a any information to support his hearing the Consumer Price Index.
misbranded drug with intent to defraud request, OSI concludes that Kincaid DATES: Applicable beginning January 13,
or mislead, in violation of sections failed to raise a genuine and substantial 2018, unless an office administering a
301(c) and 303(a)(2) of the FD&C Act (21 issue of fact requiring a hearing. program using the guidelines specifies a
U.S.C. 331(c) and 333(a)(2)) and 18 Therefore, OSI denies Kincaid’s request different applicability date for that
U.S.C. 2. The basis for this conviction for a hearing. particular program.
VerDate Sep<11>2014 18:27 Jan 17, 2018 Jkt 244001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\18JAN1.SGM 18JAN1](https://thefederalregister.org/doc/83_FR_2653/page/2.svg)
Document Created: 2018-01-18 00:42:36
Document Modified: 2018-01-18 00:42:36
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | This order is applicable January 18, 2018. | |
| 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. | |
| FR Citation | 83 FR 2641 |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR