[Federal Register Volume 85, Number 230 (Monday, November 30, 2020)]
[Notices]
[Pages 76581-76582]
[FR Doc No: 2020-26262]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1337]

John Kapoor: Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing an
order under the Federal Food, Drug, and Cosmetic Act (FD&C Act)
permanently debarring John Kapoor 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 John Kapoor was
convicted of a felony under Federal law for conduct that relates to the
regulation of a drug product under the FD&C Act. John Kapoor was given
notice of the proposed permanent debarment and an opportunity to
request a hearing to show why he should not be debarred. Mr. Kapoor,
through counsel, submitted a letter to FDA, which commented on some of
the factual circumstances surrounding the case. In the letter, he also
stated that he did not intend to request a hearing nor, however, would
he acquiesce to debarment. As of August 26, 2020 (30 days after receipt
of the notice), Mr. Kapoor has not requested a hearing. His failure to
request a hearing constitutes a waiver of his right to a hearing
concerning this action.

DATES: This order is applicable November 30, 2020.

ADDRESSES: Submit applications for special termination of debarment to
the Dockets Management Staff (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>, or
https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, (ELEM-4029) Division
of Enforcement, Office of Strategic Planning and Operational Policy,
Office of Regulatory Affairs, Food and Drug Administration, 12420
Parklawn Dr., Rockville, MD 20857<EMAIL_ADDRESS>240-402-
8743.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B))
requires debarment of an individual from providing services in any
capacity to a person that has an approved or pending drug product
application if FDA finds that the individual has been convicted of a
felony under Federal law for conduct relating to the regulation of any
drug product under the FD&C Act. On January 23, 2020, Mr. Kapoor was
convicted as defined in section 306(l)(1) of the FD&C Act when judgment
was entered against him in the U.S. District Court for the District of
Massachusetts, after a jury verdict, to one count of Racketeering
Conspiracy in violation of 18 U.S.C. 1962(d). The pattern of
racketeering activity he was convicted of included engaging in multiple
acts of mail fraud (18 U.S.C. 1341) and wire fraud (18 U.S.C. 1343).
    The factual basis for this conviction is as follows: Mr. Kapoor was
the founder and majority owner of Insys Therapeutics Inc. (Insys), a
Delaware Corporation, with headquarters in Chandler, Arizona. In
addition, he held executive management positions at Insys, including
Executive Chairman of the Board of Directors and, for a time,

Chief Executive Officer (CEO). Insys developed and owned a drug called
SUBSYS, a liquid formulation of fentanyl to be applied under the
tongue. FDA approved SUBSYS for the management of breakthrough pain in
adult cancer patients who are already receiving and are already
tolerant to opioid therapy for their underlying persistent cancer pain.
From 2012 and continuing through 2015, Mr. Kapoor oversaw a conspiracy
whereby employees of Insys bribed medical practitioners in various
states to get those practitioners to increase prescribing SUBSYS to
their patients. Mr. Kapoor, along with his co-conspirators, measured
the effect of these bribes on each practitioner's prescribing habits
and on the revenue that each bribed practitioner generated for Insys.
Mr. Kapoor, along with his co-conspirators, reduced or eliminated
bribes paid to those practitioners who failed to meet the minimum
prescription requirements or failed to generate enough revenue to
justify additional bribes.
    To further this conspiracy, Mr. Kapoor oversaw a scheme whereby
Insys executives conspired to mislead and defraud health insurance
providers to ensure those providers approved payment for SUBSYS. Insys
achieved this goal by establishing the ``Insys Reimbursement Center,''
which was designed to shift the burden of seeking prior authorization
for SUBSYS from practitioners to Insys. This allowed Insys to determine
what medical information was presented to insurers. Mr. Kapoor and his
co-conspirators directed Insys employees to mislead insurers to obtain
payment authorization.
    As a result of this conviction, FDA sent Mr. Kapoor by certified
mail on July 16, 2020, a notice proposing to permanently debar him from
providing services in any capacity to a person that has an approved or
pending drug product application. The proposal was based on a finding,
under section 306(a)(2)(B) of the FD&C Act, that Mr. Kapoor was
convicted of a felony under Federal law for conduct relating to the
regulation of a drug product under the FD&C Act. The proposal also
offered Mr. Kapoor 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
an election not to use the opportunity for a hearing and a waiver of
any contentions concerning this action. Mr. Kapoor received the
proposal on July 27, 2020. Mr. Kapoor, through counsel, submitted a
letter to FDA dated August 12, 2020, which commented on some of the
factual circumstances surrounding the case. In the letter, he also
stated that he did not intend to request a hearing nor, however, would
he acquiesce to debarment. Since he did not request a hearing within
the timeframe prescribed by regulation, Mr. Kapoor has waived his
opportunity for a hearing and 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(a)(2)(B) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Mr.
Kapoor has been convicted of a felony under Federal law for conduct
otherwise relating to the regulation of a drug product under the FD&C
Act.
    As a result of the foregoing finding, Mr. Kapoor, is permanently
debarred from providing services in any capacity to a person with an
approved or pending drug product application, effective (see DATES)
(see sections 306(a)(2)(B) and (c)(2)(A)(ii) of the FD&C Act). Any
person with an approved or pending drug product application who
knowingly employs or retains as a consultant or contractor, or
otherwise uses the services of Mr. Kapoor, in any capacity during his
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 Mr. Kapoor provides
services in any capacity to a person with an approved or pending drug
product application during his period of debarment, 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
application from Mr. Kapoor during his period of debarment, other than
in connection with an audit under section 306 of the FD&C Act (section
306(c)(1)(B) of the FD&C Act). Note that, for purposes of section 306
of the FD&C Act, a ``drug product'' is defined as a drug subject to
regulation 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) (see section 201(dd) of the FD&C Act (21 U.S.C.
321(dd))).
    Any application by Mr. Kapoor for special termination of debarment
under section 306(d)(4) of the FD&C Act should be identified with
Docket No. FDA-2020-N-1337 and sent to the Dockets Management Staff
(see ADDRESSES). The public availability of information in these
submissions is governed by 21 CFR 10.20.
    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,<PHONE_NUMBER>.

    Dated: November 23, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26262 Filed 11-27-20; 8:45 am]
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[Federal Register Volume 85, Number 119 (Friday, June 19, 2020)]
[Proposed Rules]
[Pages 37031-37033]
[FR Doc No: 2020-13198]

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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 85, No. 119 / Friday, June 19, 2020 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0467; Product Identifier 2020-NM-056-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for all The Boeing Company Model 717-200 airplanes. This proposed AD
was prompted by a report which indicated that during takeoff, both the
captain's and first officer's airspeed indications froze at 80 knots.
This proposed AD would require modifying the air data heat (ADH) system
to display the proper airspeed indications, testing, and any applicable
corrective actions. The FAA is proposing this AD to address the unsafe
condition on these products.

DATES: The FAA must receive comments on this proposed AD by August 3,
2020.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Boeing
Commercial Airplanes, Attention: Contractual & Data Services (C&DS),
2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600;
telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com. You may
view this service information at the FAA, Airworthiness Products
Section, Operational Safety Branch, 2200 South 216th St., Des Moines,
WA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>. It is also available on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0467.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0467; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, any comments received, and other information. The street
address for Docket Operations is listed above. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Eric Igama, Aerospace Engineer,
Systems and Equipment Section, FAA, Los Angeles ACO Branch, 3960
Paramount Boulevard, Lakewood, CA 90712-4137; phone:<PHONE_NUMBER>; fax:
562-627-5210; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2020-0467;
Product Identifier 2020-NM-056-AD'' at the beginning of your comments.
The FAA specifically invites comments on the overall regulatory,
economic, environmental, and energy aspects of this NPRM. The FAA will
consider all comments received by the closing date and may amend this
NPRM because of those comments.
    The FAA will post all comments, without change, to https://www.regulations.gov, including any personal information you provide.
The FAA will also post a report summarizing each substantive verbal
contact received about this proposed AD.

Discussion

    The FAA has received a report which indicated that during takeoff,
both the captain's and first officer's airspeed indications froze at 80
knots. A review of the weather at the departure airport indicated an
outside air temperature of 25 degrees Fahrenheit and wind at
approximately 20 knots in light snow. The airplane had been waiting in
this weather condition for about two hours for de-icing before takeoff.
A review of the flight data recorder from this event indicated the
airspeed became irregular and could not be read during takeoff until
the airplane reached 6,000 feet above ground level. The recorded data
also indicated that the pitot tube was possibly blocked with ice.
    Pitot tubes blocked by ice, if not addressed, could affect the
airspeed indication provided to the flightcrew through the ADH system
and result in loss of aircraft controllability.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Boeing Alert Service Bulletin 717-30A0009, dated
March 31, 2020. This service information describes procedures for
modifying the ADH system by installing new wires between the station
(STA) 110 relay panel and the left radio rack, and doing tests and
applicable corrective actions until the tests are passed. This service
information is reasonably available because the interested parties have
access to it through their normal course of business or by the means
identified in the ADDRESSES section.

FAA's Determination

    The FAA is proposing this AD because the agency evaluated all the
relevant information and determined the unsafe condition described
previously is likely to exist or develop in other products of the same
type design.

Other Relevant Rulemaking

    Group 1 airplanes in Boeing Alert Service Bulletin 717-30A0009,
dated March 31, 2020, are identified as airplanes with a concurrent
requirement: Boeing Alert Service Bulletin 717-30A0003. AD 2007-13-01,
Amendment 39-15105 (72 FR 33852, June 20, 2007) (``AD 2007-13-01'')
requires accomplishing the actions

specified in Boeing Alert Service Bulletin 717-30A0003, Revision 2,
dated November 28, 2006. AD 2007-13-01 requires operators to accomplish
the actions (changing the wiring for the air data sensor heating
system) within 24 months after July 25, 2007 (the effective date of AD
2007-13-01). The FAA issued that AD to address the display of suspect
or erratic airspeed indications during heavy rain conditions, which
could reduce the ability of the flightcrew to maintain the safe flight
and landing of the airplane. Since AD 2007-13-01 already requires the
concurrent service information, the FAA has not included Boeing Alert
Service Bulletin 717-30A0003, Revision 2, dated November 28, 2006, as a
concurrent requirement in this proposed AD.

Proposed AD Requirements

    This proposed AD would require accomplishment of the actions
identified as ``RC'' (required for compliance) in the Accomplishment
Instructions of Boeing Alert Service Bulletin 717-30A0009, dated March
31, 2020, described previously except for any differences identified as
exceptions in the regulatory text of this proposed AD.
    For information on the procedures and compliance times, see this
service information at https://www.regulations.gov by searching for and
locating Docket No. FAA-2020-0467.

Costs of Compliance

    The FAA estimates that this proposed AD affects 113 airplanes of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:

                                      Estimated Costs for Required Actions
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                                                                                Cost per      Cost on U.S.
               Action                         Labor cost            Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Modification *.....................  12 work-hours x $85 per              $4,863          $5,883       $664,779
                                      hour = $1,020.
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* The modification costs include the costs for testing. The FAA has received no definitive data on the costs of
  the corrective actions necessary to pass the testing.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, Section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    The FAA has determined that this proposed AD would not have
federalism implications under Executive Order 13132. This proposed AD
would not have a substantial direct effect on the States, on the
relationship between the national Government and the States, or on the
distribution of power and responsibilities among the various levels of
government.
    For the reasons discussed above, I certify that the proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

The Boeing Company: Docket No. FAA-2020-0467; Product Identifier
2020-NM-056-AD.

(a) Comments Due Date

    The FAA must receive comments on this AD action by August 3,
2020.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all The Boeing Company Model 717-200
airplanes, certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 30, Ice and rain
protection.

(e) Unsafe Condition

    This AD was prompted by a report which indicated that during
takeoff, both the captain's and first officer's airspeed indicators
froze at 80 knots. The FAA is issuing this AD to address pitot tubes
blocked by ice, which could affect the airspeed indication provided
to the flightcrew through the air data heat (ADH) system and result
in loss of aircraft controllability.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Required Actions

    Except as specified in paragraph (h) of this AD: At the
applicable times specified in paragraph 1.E., ``Compliance,'' of
Boeing Alert Service Bulletin 717-30A0009, dated March 31, 2020, do
all applicable actions identified as ``RC'' (required for
compliance) in, and in accordance with, the Accomplishment
Instructions of Boeing Alert Service Bulletin 717-30A0009, dated
March 31, 2020.

(h) Exception to Service Information Specifications

    Where Boeing Alert Service Bulletin 717-30A0009, dated March 31,
2020, uses the phrase ``the original issue date of this service
bulletin,'' this AD requires using ``the effective date of this
AD.''

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles ACO Branch, FAA, has the authority
to approve AMOCs for this AD, if requested using the procedures
found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your
request to your

principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the manager of the
certification office, send it to the attention of the person
identified in paragraph (j)(1) of this AD. Information may be
emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by The Boeing Company Organization Designation
Authorization (ODA) that has been authorized by the Manager, Los
Angeles ACO Branch, FAA, to make those findings. To be approved, the
repair method, modification deviation, or alteration deviation must
meet the certification basis of the airplane, and the approval must
specifically refer to this AD.
    (4) For service information that contains steps that are labeled
as Required for Compliance (RC), the provisions of paragraphs
(i)(4)(i) and (ii) of this AD apply.
    (i) The steps labeled as RC, including substeps under an RC step
and any figures identified in an RC step, must be done to comply
with the AD. If a step or substep is labeled ``RC Exempt,'' then the
RC requirement is removed from that step or substep. An AMOC is
required for any deviations to RC steps, including substeps and
identified figures.
    (ii) Steps not labeled as RC may be deviated from using accepted
methods in accordance with the operator's maintenance or inspection
program without obtaining approval of an AMOC, provided the RC
steps, including substeps and identified figures, can still be done
as specified, and the airplane can be put back in an airworthy
condition.

(j) Related Information

    (1) For more information about this AD, contact Eric Igama,
Aerospace Engineer, Systems and Equipment Section, FAA, Los Angeles
ACO Branch, 3960 Paramount Boulevard, Lakewood, CA 90712-4137;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110 SK57, Seal Beach, CA 90740-
5600; telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com. You may view this referenced service
information at the FAA, Airworthiness Products Section, Operational
Safety Branch, 2200 South 216th St., Des Moines, WA. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued on June 4, 2020.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2020-13198 Filed 6-18-20; 8:45 am]
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