John D. McCoy; Denial of Hearing; Final Debarment Order, 49099-49101 [2018-21211]

Download as PDF Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices whether a 510(k) is appropriate for review as a Special 510(k). In general, a change to an existing device may be appropriate for a Special 510(k) when: (1) The proposed change is made and submitted by the manufacturer authorized to market the existing device; (2) performance data are unnecessary, or if performance data are necessary, well-established methods are available to evaluate the change; and (3) all performance data necessary to support substantial equivalence can be reviewed in a summary or risk analysis format. When finalized, this guidance will supersede the Special 510(k) policy in the 1998 guidance entitled ‘‘The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.’’ II. Significance of Guidance This draft guidance is being issued consistent with FDA’s good guidance Information/default.htm. Persons unable to download an electronic copy of ‘‘The Special 510(k) Program’’ may send an email request to CDRHGuidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 18008 to identify the guidance you are requesting. III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. This guidance document is also available at https://www.regulations.gov or https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory This draft guidance refers to previously approved collections of information. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in the following FDA regulations have been approved by OMB as listed in the following table: IV. Paperwork Reduction Act of 1995 OMB control No. Topic 807, subpart E .......................................... 801 ............................................................ 820 ............................................................ Premarket Notification .................................................................................................. Medical Device Labeling Regulations .......................................................................... Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation ..... [FR Doc. 2018–21141 Filed 9–27–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0613] John D. McCoy; Denial of Hearing; Final Debarment Order AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is denying a request for a hearing submitted by John D. McCoy (McCoy) and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring McCoy for 4 years 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 McCoy was convicted of a misdemeanor under Federal law for conduct relating to the regulation of a drug product under the SUMMARY: amozie on DSK3GDR082PROD with NOTICES1 practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘The Special 510(k) Program.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. 21 CFR part; guidance; or FDA form Dated: September 24, 2018. Leslie Kux, Associate Commissioner for Policy. VerDate Sep<11>2014 19:22 Sep 27, 2018 Jkt 244001 49099 FD&C Act and that the conduct underlying the conviction undermines the process for the regulation of drugs. In determining the appropriateness and period of McCoy’s debarment, FDA has considered the relevant factors listed in the FD&C Act. McCoy has failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action. DATES: The order is applicable September 28, 2018. ADDRESSES: Any application for termination of debarment by McCoy 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 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 0910–0120 0910–0485 0910–0073 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–2011–N– 0613. An application will be placed in the docket and, unless submitted as E:\FR\FM\28SEN1.SGM 28SEN1 49100 Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices amozie on DSK3GDR082PROD with NOTICES1 ‘‘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. • 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/201523389.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: Rachael Vieder Linowes, Office of Scientific Integrity, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4206, Silver Spring, MD 20993, 240–402–5931. SUPPLEMENTARY INFORMATION: I. Background Section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C. 335a(b)(2)(B)(i)(I)) permits FDA to debar an individual if it finds that: (1) The individual has been convicted of a misdemeanor under Federal law for conduct relating to the development or approval, including the VerDate Sep<11>2014 19:22 Sep 27, 2018 Jkt 244001 process for development or approval, of a drug product or otherwise relating to the regulation of a drug product under the FD&C Act and (2) the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs. On April 20, 2009, in the U.S. District Court for the District of Arizona, McCoy pled guilty to a misdemeanor, namely adulterating a drug while held for sale after shipment in interstate commerce in violation of sections 301(k), 303(a)(1), and 501(d) of the FD&C Act (21 U.S.C. 331(k), 333(a)(1) and 351(d)). The conduct underlying the conviction involved the adulteration of BOTOX®/ BOTOX® Cosmetic (BOTOX®). BOTOX® is a biological product derived from Botulinum Toxin Type A that is manufactured by Allergan, Inc., and was approved by FDA for use on humans. Toxin Research International was an Arizona corporation that marketed and sold TRI-Toxin, a Botulinum Toxin Type A product that was neither approved nor licensed by FDA. According to the records of the criminal proceedings, McCoy, while a physician at Skinovative Laser Center, mixed FDA-approved BOTOX® with TRI-toxin, while the BOTOX® was held for sale after shipment in interstate commerce, such that the BOTOX® was adulterated under section 501(d) of the FD&C Act. By letter dated October 24, 2011, FDA’s Office of Regulatory Affairs (ORA) notified McCoy of its proposal to debar him for 4 years from providing services in any capacity to a person having an approved or pending drug product application. The proposal outlined findings concerning three relevant factors ORA considered in determining the appropriateness and period of debarment, as provided in section 306(c)(3) of the FD&C Act. ORA found that the nature and seriousness of the offense and the nature and extent of voluntary steps to mitigate the effect on the public were unfavorable factors for McCoy. The absence of prior convictions involving matters within FDA’s jurisdiction was a favorable factor. ORA concluded, ‘‘Weighing all the factors, particularly the nature and seriousness of the conduct underlying your conviction, the Agency has determined that the unfavorable factors outweigh the favorable factors, and therefore warrant the imposition of a four year permissible debarment in this case.’’ In a letter dated November 23, 2011, through counsel, McCoy requested a hearing on the proposal. In his hearing request, McCoy argues that there are disputed issues of material fact that FDA must consider, under section PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 306(c)(3) of the FD&C Act, in determining the appropriateness and period of debarment. McCoy also indicated that additional information justifying the hearing would be forthcoming. More than 60 days have passed from the date McCoy received ORA’s letter, and McCoy has not filed any additional information. Under the authority delegated to him by the Commissioner of Food and Drugs, the Director of the Office of Scientific Integrity (OSI) has considered McCoy’s request for a hearing. Hearings are granted only if there is a genuine and substantial issue of fact. 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 § 12.24(b) (21 CFR 12.24(b))). OSI has considered McCoy’s arguments and concludes that they are unpersuasive and fail to raise a genuine and substantial issue of fact requiring a hearing. II. Arguments In his hearing request, McCoy first contends that there are disputed issues of material fact with respect to whether he voluntarily acted to mitigate the impact of his offense on the public (see section 306(c)(3)(C) of the FD&C Act). ORA found no evidence that McCoy took any voluntary steps to mitigate the impact on the public. McCoy has not provided any specific allegations or evidence supporting his general assertion that the facts underlying ORA’s findings are in dispute. Although McCoy indicated that he would submit additional information supporting his hearing request, he has not done so. Under § 12.24(b)(2), a hearing will not be granted on the basis of mere allegations or denials or general descriptions of positions and contentions. McCoy’s bare assertion that there are disputed issues of fact with respect to that consideration fails to create a genuine and substantial issue of fact that warrants a hearing. Upon similar reasoning, McCoy’s claim that the disputed issues of fact are not limited to those raised in his hearing request also falls far short of justifying a hearing. Finally, McCoy contends that there are disputed issues of material fact with respect to whether, under section 306(c)(3)(D) of the FD&C Act, the extent to which changes in ownership, management, or operations has corrected the causes of any offense involved and provide reasonable assurances that the offense will not E:\FR\FM\28SEN1.SGM 28SEN1 amozie on DSK3GDR082PROD with NOTICES1 Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices occur again. Yet, again, McCoy has not provided any specific allegations or evidence to challenge ORA’s determination that this consideration does not apply to him. FDA need only address the considerations in section 306(c)(3) of the FD&C Act ‘‘where applicable.’’ The considerations in section 306(c)(3) of the FD&C Act are not only for individuals but also for corporations, partnerships, and associations subject to permissive debarment. The consideration at issue does not typically apply to individuals because individuals are incapable of changes in ownership or management and could only alter the current operations of a business enterprise in which they are currently engaged. Even assuming arguendo that an individual could point to changes in his or her current business practices as an applicable consideration under section 306(c)(3) of the FD&C Act, McCoy’s unsubstantiated contention that there are disputed issues of fact with respect to that consideration fails to create a genuine and substantial issue of fact that warrants a hearing. Based on the factual findings in the proposal to debar and on the record, OSI finds that a 4-year debarment is appropriate. Although McCoy has no previous criminal convictions related to matters within the jurisdiction of FDA, this sole positive factor does not counterbalance the nature and seriousness of his offense and lack of voluntary steps taken to mitigate the effect on the public. As noted in the proposal to debar, McCoy’s actions occurred on a repeated basis, and ‘‘[his] conduct created a risk of injury to [his] patients . . ., undermined the Agency’s oversight of an approved drug product, and seriously undermined the integrity of the Agency’s regulation of drug products.’’ As a result of the foregoing findings, McCoy is debarred for 4 years 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)(iii) and 21 U.S.C. 321(dd)). Any person with an approved or pending drug product application, who knowingly uses the services of McCoy, in any capacity during his period of debarment, will be subject to civil money penalties (section 307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))). If McCoy, 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 (section 307(a)(7) of the FD&C Act). In addition, FDA will not accept or review any abbreviated new drug applications submitted by or with the assistance of McCoy during his period of debarment (section 306(c)(1)(B) of the FD&C Act). III. Findings and Order Therefore, the Director of OSI, under section 306(b)(2)(B)(i)(I) of the FD&C Act and under authority delegated to him by the Commissioner of Food and Drugs, finds that: (1) McCoy has been convicted of a misdemeanor under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product or otherwise relating to the regulation of a drug product under the FD&C Act and (2) the conduct which served as the basis for the conviction undermines the process for the regulation of drugs. FDA has considered the applicable factors listed in section 306(c)(3) of the FD&C Act and determined that a debarment of 4 years is appropriate. ACTION: VerDate Sep<11>2014 19:22 Sep 27, 2018 Jkt 244001 Dated: September 25, 2018. George M. Warren, Director, Office of Scientific Integrity. [FR Doc. 2018–21211 Filed 9–27–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–3424] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. Notice. The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The general function of the committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues. At least one portion of the meeting will be closed to the public. DATES: The meeting will be held on November 8, 2018, from 11 a.m. to 2:45 p.m. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993–0002. SUMMARY: PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 49101 Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/AboutAdvisory Committees/ucm408555.htm. For those unable to attend in person, the meeting will also be webcast and will be available at the following link: https://collaboration.fda.gov/ vrbpac1118/. FOR FURTHER INFORMATION CONTACT: Serina Hunter-Thomas, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6338, Silver Spring, MD 20993–0002, 240–402–5771, serina.hunter-thomas@ fda.hhs.gov or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s website at https://www.fda.gov/ AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: On November 8, 2018, the Center for Biologics Evaluation and Research’s (CBER) VRBPAC committee will meet in open session to hear an overview of the research program in the Laboratory of DNA Viruses (LDV), Division of Viral Products (DVP), Office of Vaccines Research and Review (OVRR), CBER, FDA. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s website after the meeting. Background material is available at https://www.fda.gov/Advisory Committees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: On November 8, 2018, from 11 a.m. to 1:50 p.m., the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact E:\FR\FM\28SEN1.SGM 28SEN1

Agencies

[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)]
[Notices]
[Pages 49099-49101]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21211]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0613]


John D. McCoy; Denial of Hearing; Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is denying a request 
for a hearing submitted by John D. McCoy (McCoy) and is issuing an 
order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
debarring McCoy for 4 years 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 McCoy was convicted of a misdemeanor 
under Federal law for conduct relating to the regulation of a drug 
product under the FD&C Act and that the conduct underlying the 
conviction undermines the process for the regulation of drugs. In 
determining the appropriateness and period of McCoy's debarment, FDA 
has considered the relevant factors listed in the FD&C Act. McCoy has 
failed to file with the Agency information and analyses sufficient to 
create a basis for a hearing concerning this action.

DATES: The order is applicable September 28, 2018.

ADDRESSES: Any application for termination of debarment by McCoy 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-
2011-N-0613. An application will be placed in the docket and, unless 
submitted as

[[Page 49100]]

``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.
     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: Rachael Vieder Linowes, Office of 
Scientific Integrity, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 1, Rm. 4206, Silver Spring, MD 20993, 240-402-5931.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C. 
335a(b)(2)(B)(i)(I)) permits FDA to debar an individual if it finds 
that: (1) The individual has been convicted of a misdemeanor under 
Federal law for conduct relating to the development or approval, 
including the process for development or approval, of a drug product or 
otherwise relating to the regulation of a drug product under the FD&C 
Act and (2) the type of conduct that served as the basis for the 
conviction undermines the process for the regulation of drugs.
    On April 20, 2009, in the U.S. District Court for the District of 
Arizona, McCoy pled guilty to a misdemeanor, namely adulterating a drug 
while held for sale after shipment in interstate commerce in violation 
of sections 301(k), 303(a)(1), and 501(d) of the FD&C Act (21 U.S.C. 
331(k), 333(a)(1) and 351(d)). The conduct underlying the conviction 
involved the adulteration of BOTOX[supreg]/BOTOX[supreg] Cosmetic 
(BOTOX[supreg]). BOTOX[supreg] is a biological product derived from 
Botulinum Toxin Type A that is manufactured by Allergan, Inc., and was 
approved by FDA for use on humans. Toxin Research International was an 
Arizona corporation that marketed and sold TRI-Toxin, a Botulinum Toxin 
Type A product that was neither approved nor licensed by FDA. According 
to the records of the criminal proceedings, McCoy, while a physician at 
Skinovative Laser Center, mixed FDA-approved BOTOX[supreg] with TRI-
toxin, while the BOTOX[supreg] was held for sale after shipment in 
interstate commerce, such that the BOTOX[supreg] was adulterated under 
section 501(d) of the FD&C Act.
    By letter dated October 24, 2011, FDA's Office of Regulatory 
Affairs (ORA) notified McCoy of its proposal to debar him for 4 years 
from providing services in any capacity to a person having an approved 
or pending drug product application. The proposal outlined findings 
concerning three relevant factors ORA considered in determining the 
appropriateness and period of debarment, as provided in section 
306(c)(3) of the FD&C Act. ORA found that the nature and seriousness of 
the offense and the nature and extent of voluntary steps to mitigate 
the effect on the public were unfavorable factors for McCoy. The 
absence of prior convictions involving matters within FDA's 
jurisdiction was a favorable factor. ORA concluded, ``Weighing all the 
factors, particularly the nature and seriousness of the conduct 
underlying your conviction, the Agency has determined that the 
unfavorable factors outweigh the favorable factors, and therefore 
warrant the imposition of a four year permissible debarment in this 
case.''
    In a letter dated November 23, 2011, through counsel, McCoy 
requested a hearing on the proposal. In his hearing request, McCoy 
argues that there are disputed issues of material fact that FDA must 
consider, under section 306(c)(3) of the FD&C Act, in determining the 
appropriateness and period of debarment. McCoy also indicated that 
additional information justifying the hearing would be forthcoming. 
More than 60 days have passed from the date McCoy received ORA's 
letter, and McCoy has not filed any additional information.
    Under the authority delegated to him by the Commissioner of Food 
and Drugs, the Director of the Office of Scientific Integrity (OSI) has 
considered McCoy's request for a hearing. Hearings are granted only if 
there is a genuine and substantial issue of fact. 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 Sec.  12.24(b) (21 CFR 12.24(b))).
    OSI has considered McCoy's arguments and concludes that they are 
unpersuasive and fail to raise a genuine and substantial issue of fact 
requiring a hearing.

II. Arguments

    In his hearing request, McCoy first contends that there are 
disputed issues of material fact with respect to whether he voluntarily 
acted to mitigate the impact of his offense on the public (see section 
306(c)(3)(C) of the FD&C Act). ORA found no evidence that McCoy took 
any voluntary steps to mitigate the impact on the public. McCoy has not 
provided any specific allegations or evidence supporting his general 
assertion that the facts underlying ORA's findings are in dispute. 
Although McCoy indicated that he would submit additional information 
supporting his hearing request, he has not done so. Under Sec.  
12.24(b)(2), a hearing will not be granted on the basis of mere 
allegations or denials or general descriptions of positions and 
contentions. McCoy's bare assertion that there are disputed issues of 
fact with respect to that consideration fails to create a genuine and 
substantial issue of fact that warrants a hearing. Upon similar 
reasoning, McCoy's claim that the disputed issues of fact are not 
limited to those raised in his hearing request also falls far short of 
justifying a hearing.
    Finally, McCoy contends that there are disputed issues of material 
fact with respect to whether, under section 306(c)(3)(D) of the FD&C 
Act, the extent to which changes in ownership, management, or 
operations has corrected the causes of any offense involved and provide 
reasonable assurances that the offense will not

[[Page 49101]]

occur again. Yet, again, McCoy has not provided any specific 
allegations or evidence to challenge ORA's determination that this 
consideration does not apply to him. FDA need only address the 
considerations in section 306(c)(3) of the FD&C Act ``where 
applicable.'' The considerations in section 306(c)(3) of the FD&C Act 
are not only for individuals but also for corporations, partnerships, 
and associations subject to permissive debarment. The consideration at 
issue does not typically apply to individuals because individuals are 
incapable of changes in ownership or management and could only alter 
the current operations of a business enterprise in which they are 
currently engaged. Even assuming arguendo that an individual could 
point to changes in his or her current business practices as an 
applicable consideration under section 306(c)(3) of the FD&C Act, 
McCoy's unsubstantiated contention that there are disputed issues of 
fact with respect to that consideration fails to create a genuine and 
substantial issue of fact that warrants a hearing.
    Based on the factual findings in the proposal to debar and on the 
record, OSI finds that a 4-year debarment is appropriate. Although 
McCoy has no previous criminal convictions related to matters within 
the jurisdiction of FDA, this sole positive factor does not 
counterbalance the nature and seriousness of his offense and lack of 
voluntary steps taken to mitigate the effect on the public. As noted in 
the proposal to debar, McCoy's actions occurred on a repeated basis, 
and ``[his] conduct created a risk of injury to [his] patients . . ., 
undermined the Agency's oversight of an approved drug product, and 
seriously undermined the integrity of the Agency's regulation of drug 
products.''

III. Findings and Order

    Therefore, the Director of OSI, under section 306(b)(2)(B)(i)(I) of 
the FD&C Act and under authority delegated to him by the Commissioner 
of Food and Drugs, finds that: (1) McCoy has been convicted of a 
misdemeanor under Federal law for conduct relating to the development 
or approval, including the process for development or approval, of a 
drug product or otherwise relating to the regulation of a drug product 
under the FD&C Act and (2) the conduct which served as the basis for 
the conviction undermines the process for the regulation of drugs. FDA 
has considered the applicable factors listed in section 306(c)(3) of 
the FD&C Act and determined that a debarment of 4 years is appropriate.
    As a result of the foregoing findings, McCoy is debarred for 4 
years 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)(iii) and 21 U.S.C. 321(dd)). Any 
person with an approved or pending drug product application, who 
knowingly uses the services of McCoy, in any capacity during his period 
of debarment, will be subject to civil money penalties (section 
307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))). If McCoy, 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 (section 307(a)(7) of the FD&C Act). In addition, 
FDA will not accept or review any abbreviated new drug applications 
submitted by or with the assistance of McCoy during his period of 
debarment (section 306(c)(1)(B) of the FD&C Act).

    Dated: September 25, 2018.
George M. Warren,
Director, Office of Scientific Integrity.
[FR Doc. 2018-21211 Filed 9-27-18; 8:45 am]
 BILLING CODE 4164-01-P

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