[Federal Register Volume 88, Number 114 (Wednesday, June 14, 2023)]
[Notices]
[Pages 38935-38942]
[FR Doc No: 2023-12728]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2017-0108 (Notice No. 2021-07)]

Hazardous Materials: Notification of Termination of Certain
Explosive Classification Approvals Due to Non-Compliance With the UN
Model Regulation Test Series 6(d) Requirement

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Notification of termination of explosive approvals.

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

SUMMARY: PHMSA has terminated the Explosive (EX) classification
approvals listed below. PHMSA published a Federal Register Notice on
May 4, 2021, notifying the approval holders listed below that PHMSA
intended to terminate their approvals for failure to provide proof that
the approved explosives successfully completed the UN Test Series 6(d)
of Part I of the UN Manual of Tests and Criteria. The notice advised
approval holders that they must either show why their approvals should
not be terminated or apply for a modification of their approval prior
to June 3, 2021.

FOR FURTHER INFORMATION CONTACT: Mrs. Harpreet Singh, Chief, Energetic
Materials Branch, Sciences and Engineering Division,<PHONE_NUMBER>,
PHMSA, 1200 New Jersey Avenue SE, Washington, DC 20590-0001.

SUPPLEMENTARY INFORMATION:

I. Introduction

    The Pipeline and Hazardous Materials Safety Administration's
(PHMSA) Office of Hazardous Materials Safety (OHMS) provides notice of
the termination of the approvals listed below. The below-listed
approval holders failed to provide evidence that their explosives
successfully passed UN Test Series 6(d) of Part I of the UN Manual of
Tests and Criteria (UN 6(d) testing) as required by 49 CFR 172.102,
Special Provision 347.
    Publication in the Federal Register is an authorized method for
PHMSA to serve the approval holders in accordance with 49 CFR
105.35(a)(3). The approval holders listed below failed to submit
evidence that the UN 6(d) testing had been successfully completed and
failed to apply for a modification of their approval. Therefore, PHMSA
terminated their approvals, effective June 3, 2021.

II. Background

    Final rule HM-215O \1\ amended Special Provision 347 to require
successful completion of UN 6(d) testing. This change affected
explosives classified as Division 1.4S hazardous materials and impacted
UN Numbers UN0349, UN0367, UN0384, and UN0481. This requirement became
effective for transportation by aircraft under the International Civil
Aviation Organization (ICAO) on January 1, 2019; for transportation by
vessel under the International Maritime Organization (IMO) on January
1, 2020; and for domestic highway and rail transportation on May 10,
2021. PHMSA attempted to contact the affected approval holders in
October 2020 via a Safety Advisory Notice issued from the PHMSA EX
Portal to alert holders of the May 10, 2021, compliance deadline. On
May 4, 2021, PHMSA issued a Federal Register Notice \2\ [Docket No.
PHMSA-2017-0108, Notice No. 2021-03] which notified the approval
holders of PHMSA's intent to terminate all approvals that failed to
provide PHMSA with documentation showing that the UN 6(d) test had been
successfully completed by June 3, 2021. As noted above, publication in
the Federal Register is an authorized method for PHMSA to serve the
approval holders in accordance with 49 CFR 105.35(a)(3). The approval
holders listed below failed to submit evidence that the UN 6(d) testing
had been successfully completed and failed to apply for a modification
of their approval. Therefore, PHMSA terminated their approvals,
effective June 3, 2021. As of July 2021, PHMSA had not received any
records that the required UN 6(d) testing had been successfully
completed for the below-listed EX number(s).
---------------------------------------------------------------------------

    \1\ 85 FR 27810 (May 11, 2020).
    \2\ 86 FR 23782 (May 4, 2021).
---------------------------------------------------------------------------

III. Action

    PHMSA terminated the below EX classification approvals in
accordance with Sec.  107.713(b)(1).

IV. Terminated Approvals

    EX approval holders are listed in alphabetical order.

------------------------------------------------------------------------
         EX No.               UN No.            EX approval holder
------------------------------------------------------------------------
EX1999100239............          UN0367  Accurate Arms Company, Inc.
EX1988040100............          UN0367  Accurate Energetic Systems,
                                           LLC.
EX1988040101............          UN0367  Accurate Energetic Systems,
                                           LLC.
EX1989110272............          UN0367  Accurate Energetic Systems,
                                           LLC.
EX1989110427............          UN0481  Accurate Energetic Systems,
                                           LLC.
EX1989110428............          UN0481  Accurate Energetic Systems,
                                           LLC.
EX1989110429............          UN0481  Accurate Energetic Systems,
                                           LLC.
EX1989110431............          UN0481  Accurate Energetic Systems,
                                           LLC.
EX1989110432............          UN0481  Accurate Energetic Systems,
                                           LLC.

EX1989110433............          UN0481  Accurate Energetic Systems,
                                           LLC.
EX1989110434............          UN0481  Accurate Energetic Systems,
                                           LLC.
EX1989110435............          UN0481  Accurate Energetic Systems,
                                           LLC.
EX1989110437............          UN0481  Accurate Energetic Systems,
                                           LLC.
EX1990020001............          UN0367  Action Manufacturing Company.
EX1995070012............          UN0367  Action Manufacturing Company.
EX1995070013............          UN0367  Action Manufacturing Company.
EX1998110101............          UN0367  Action Manufacturing Company.
EX201302610.............          UN0367  Action Manufacturing Company.
EX1990050150............          UN0367  Aerojet Propulsion Division
                                           (APD).
EX2014060245............          UN0349  Aerojet Rocketdyne, Inc.
EX2005030114............          UN0349  Aircraft Interior Products
                                           Goodrich Corporation.
EX1990010215............          UN0367  Alliant Techsystems (ATK),
                                           formerly Thiokol Corporation,
                                           Elkton Division.
EX1988090082............          UN0367  Alliant Techsystems, Inc.
                                           (ATK).
EX1989050056............          UN0367  Alliant Techsystems Operations
                                           LLC.
EX2007110352............          UN0367  Alliant Techsystems Operations
                                           LLC.
EX1989100162............          UN0367  Alliant Techsystems Operations
                                           LLC.
EX2009010092............          UN0349  Alliant Techsystems Operations
                                           LLC.
EX2013040297............          UN0481  Alliant Techsystems Operations
                                           LLC.
EX1991050098............          UN0367  Alliant Techsystems, Inc.
EX1991050099............          UN0367  Alliant Techsystems, Inc.
EX1988040026............          UN0367  Alliant Techsystems, Inc.
                                           (formerly Honeywell, Inc.).
EX1990100007............          UN0367  Alliant Techsystems, Inc.
                                           (formerly Honeywell, Inc.).
EX1990100008............          UN0367  Alliant Techsystems, Inc.
                                           (formerly Honeywell, Inc.).
EX2004010221............          UN0349  American Airlines, Inc.
EX2018042084............          UN0349  Armtec Defense Products Co.
EX2008040391............          UN0349  Austin Powder Company.
EX1994120113............          UN0384  Baker Hughes INTEQ (Owen
                                           Compliance Services, Inc.).
EX1990080103............          UN0367  BEI Defense Systems Company,
                                           Inc.
EX1990080105............          UN0367  BEI Defense Systems Company,
                                           Inc.
EX2001050157............          UN0367  BF Goodrich Aerospace.
EX2019022522............          UN0349  Brazilian Government.
EX2018012130............          UN0349  Brazilian Government.
EX1997070025............          UN0481  Cambridge Isotope
                                           Laboratories, Inc. (CIL).
EX1997070026............          UN0481  Cambridge Isotope
                                           Laboratories, Inc. (CIL).
EX1997070027............          UN0481  Cambridge Isotope
                                           Laboratories, Inc. (CIL).
EX1997080006............          UN0481  Cambridge Isotope
                                           Laboratories, Inc. (CIL).
EX1997080007............          UN0481  Cambridge Isotope
                                           Laboratories, Inc. (CIL).
EX1997080008............          UN0481  Cambridge Isotope
                                           Laboratories, Inc. (CIL).
EX2018062063............          UN0349  Captive Technologies.
EX2009070004............          UN0367  Cartridge Actuated Devices,
                                           Inc.
EX2017080149............          UN0481  Combined Tactical Systems,
                                           Inc.
EX1997070024............          UN0481  Crescent Chemical Company.
EX1997070068............          UN0481  Crescent Chemical Company.
EX1997070069............          UN0481  Crescent Chemical Company.
EX1997070070............          UN0481  Crescent Chemical Company.
EX1997070071............          UN0481  Crescent Chemical Company.
EX1997070072............          UN0481  Crescent Chemical Company.
EX1997070073............          UN0481  Crescent Chemical Company.
EX1997070074............          UN0481  Crescent Chemical Company.
EX1997070075............          UN0481  Crescent Chemical Company.
EX1997070076............          UN0481  Crescent Chemical Company.
EX1997070077............          UN0481  Crescent Chemical Company.
EX1997070078............          UN0481  Crescent Chemical Company.
EX1997070079............          UN0481  Crescent Chemical Company.
EX1996020030............          UN0481  Dangerous Goods Management.
EX1998020066............          UN0481  Dangerous Goods Management.
EX1998110137............          UN0349  De La Mare Engineering, Inc.
EX1999060129............          UN0349  Delta Defense, Inc.
EX2002060189............          UN0367  Department of Energy.
EX1992030149............          UN0367  Department of Energy.
EX1985030145............          UN0367  Department of Energy.
EX1988020258............          UN0367  Department of Energy.
EX1998050150............          UN0349  Dynamit Nobel GmbH.
EX1998050151............          UN0349  Dynamit Nobel GmbH.
EX1997120152............          UN0481  Dynamit Nobel Wien GmbH.
EX1998050065............          UN0349  Dyno Nobel North America,
                                           (Formerly, The Ensign-
                                           Bickford Company).
EX1998070014............          UN0349  Dyno Nobel North America,
                                           (Formerly, The Ensign-
                                           Bickford Company).
EX1998070015............          UN0349  Dyno Nobel North America,
                                           (Formerly, The Ensign-
                                           Bickford Company).
EX1998070016............          UN0349  Dyno Nobel North America,
                                           (Formerly, The Ensign-
                                           Bickford Company).
EX1999010231............          UN0349  Dyno Nobel North America,
                                           (Formerly, The Ensign-
                                           Bickford Company).
EX1999010232............          UN0349  Dyno Nobel North America,
                                           (Formerly, The Ensign-
                                           Bickford Company).
EX2007060067............          UN0349  Dyno Nobel, Inc.
EX1999010179............          UN0349  Dyno Nobel, Inc. (formerly
                                           IRECO, Incorporated).

EX1994040159............          UN0349  Edison Giocattoli, S.p.a.
EX2011080094............          UN0481  Energy Technical Systems, Inc.
EX2014071026............          UN0349  Esterline Defense
                                           Technologies.
EX2014030181............          UN0349  Esterline Defense
                                           Technologies.
EX2015030271............          UN0349  Esterline Defense
                                           Technologies.
EX2013090807............          UN0349  Esterline Defense Technologies
                                           (Armtec Defense Products
                                           Co.).
EX1987040167A...........          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1987070022A...........          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1988090072A...........          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1989030240A...........          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1989120002A...........          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1991080167............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1991120107............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1991120108............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1991120109............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1991120110............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992010103............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992010118............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992010119............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992010120............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992020188............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030091............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030092............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030093............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030094............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030095............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030096............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030097............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030098............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030099............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030100............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030101............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030102............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030103............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030104............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030105............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030106............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030107............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030108............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030109............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030110............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030111............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030112............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030113............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030114............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030115............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030116............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030117............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030118............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030119............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030120............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030121............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030122............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030123............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030124............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030125............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030126............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030127............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030128............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030129............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030162............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030163............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030165............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030166............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030167............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030168............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030426............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030427............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030428............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992030429............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992040203............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992120143............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1992120144............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1993030182............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).

EX1993030183............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1993030184............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1993050013............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1993050014............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1993050184............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1993050185............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1993050186............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1993050187............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1993050188............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1993050189............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1993050190............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1993050191............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1993050192............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1993100003............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1993100004............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1994060241............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1994060242............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1994070291............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1994070292............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX1994100006............          UN0367  ET, Inc. (formerly Explosive
                                           Technology, Inc.).
EX2014080308............          UN0481  ETA S.A.
EX1989040015............          UN0367  General Dynamics Ordnance
                                           Systems, Inc.
EX2004120201............          UN0367  Goodrich Corporation Aircraft
                                           Interior Products Propulsion
                                           System.
EX2004120266............          UN0367  Goodrich Corporation Aircraft
                                           Interior Products Propulsion
                                           System.
EX2005030106............          UN0367  Goodrich Corporation Aircraft
                                           Interior Products Propulsion
                                           System.
EX2018062079............          UN0349  Government of Argentina.
EX2014010162............          UN0349  Government of Brazil.
EX2014030546............          UN0349  Government of Canada,
                                           Department of National
                                           Defence (DND).
EX2015020468............          UN0349  Government of Canada,
                                           Department of National
                                           Defence (DND).
EX2016010220............          UN0367  Government of Chile.
EX2011060808............          UN0367  Government of Egypt.
EX2012090400............          UN0367  Government of Finland.
EX2012111048............          UN0367  Government of Finland.
EX2013050931............          UN0367  Government of Finland.
EX2013050933............          UN0367  Government of Finland.
EX2013050934............          UN0367  Government of Finland.
EX2013050935............          UN0367  Government of Finland.
EX2013050937............          UN0367  Government of Finland.
EX2013050938............          UN0367  Government of Finland.
EX2013050944............          UN0367  Government of Finland.
EX2016110903............          UN0367  Government of Finland.
EX2016120102............          UN0367  Government of Finland.
EX2012080134............          UN0367  Government of Finland, Finnish
                                           Air Force Materiel Command.
EX2012080135............          UN0367  Government of Finland, Finnish
                                           Air Force Materiel Command.
EX2012080136............          UN0367  Government of Finland, Finnish
                                           Air Force Materiel Command.
EX2012080137............          UN0367  Government of Finland, Finnish
                                           Air Force Materiel Command.
EX2012080138............          UN0367  Government of Finland, Finnish
                                           Air Force Materiel Command.
EX2013040878............          UN0367  Government of Finland, Finnish
                                           Air Force Materiel Command.
EX2012080132............          UN0367  Government of Finland, Finnish
                                           Materiel Command.
EX2012080130............          UN0367  Government of Finland, Finnish
                                           Materiel Command.
EX2012080133............          UN0367  Government of Finland, Finnish
                                           Materiel Command.
EX2012080131............          UN0367  Government of Finland, Finnish
                                           Materiel Command.
EX2019082696............          UN0367  Government of Indonesia.
EX2015100860............          UN0367  Government of Israel, Ministry
                                           of Defense.
EX2016110139............          UN0367  Government of Oman.
EX2016110837............          UN0367  Government of Romania.
EX2009110194............          UN0349  Government of Spain.
EX1996110231............          UN0481  Government of Switzerland.
EX2013090134............          UN0367  Government of Switzerland.
EX2013100569............          UN0367  Government of Switzerland.
EX2013120494............          UN0367  Government of Switzerland.
EX2013121238............          UN0367  Government of Switzerland.
EX2014020631............          UN0367  Government of Switzerland.
EX2014050390............          UN0367  Government of Switzerland.
EX2014080653............          UN0367  Government of Turkey.
EX2014080655............          UN0367  Government of Turkey.
EX2019042048............          UN0349  Harris Corporation.
EX1996090033............          UN0349  HFI Pyrotechnics Inc.
EX1991020110............          UN0367  Hi-Shear Technology
                                           Corporation.
EX1995100062............          UN0367  Hughes Missile Systems Co.
EX2000100140............          UN0367  IMI Services USA, Inc.
EX2003090038............          UN0367  IMI Services USA, Inc.
EX2003090039............          UN0367  IMI Services USA, Inc.
EX2003090040............          UN0367  IMI Services USA, Inc.

EX2006020597............          UN0367  IMI Services USA, Inc.
EX2006030376............          UN0367  IMI Services USA, Inc.
EX2006030377............          UN0367  IMI Services USA, Inc.
EX2006090071............          UN0481  IMI Services USA, Inc.
EX2006090072............          UN0481  IMI Services USA, Inc.
EX2006090073............          UN0481  IMI Services USA, Inc.
EX2006090074............          UN0481  IMI Services USA, Inc.
EX2007040208............          UN0367  IMI Services USA, Inc.
EX2007040209............          UN0367  IMI Services USA, Inc.
EX2007040210............          UN0367  IMI Services USA, Inc.
EX2007040211............          UN0367  IMI Services USA, Inc.
EX2007040212............          UN0367  IMI Services USA, Inc.
EX2007040214............          UN0367  IMI Services USA, Inc.
EX2006120390............          UN0367  International Launch Services.
EX1998010222............          UN0349  Ion Track Instruments.
EX1989010061............          UN0367  IRECO, Incorporated.
EX1989010063............          UN0367  IRECO, Incorporated.
EX1990080009............          UN0367  IRECO, Incorporated.
EX2019112092............          UN0367  Kaman Aerospace Corporation,
                                           Precision Products Division.
EX1996010026............          UN0367  KDI Precision Products, Inc.
EX1993070128............          UN0384  Kilgore Flares Company, LLC
                                           (formerly Kilgore
                                           Corporation).
EX1989040062............          UN0367  Kilgore Flares Company, LLC
                                           (formerly Kilgore
                                           Corporation).
EX1989040064............          UN0367  Kilgore Flares Company, LLC
                                           (formerly Kilgore
                                           Corporation).
EX1989040065............          UN0367  Kilgore Flares Company, LLC
                                           (formerly Kilgore
                                           Corporation).
EX1989040066............          UN0367  Kilgore Flares Company, LLC
                                           (formerly Kilgore
                                           Corporation).
EX2018042083............          UN0367  Kingdom of Norway.
EX2012100180............          UN0349  Kuwaiti Government.
EX2012100261............          UN0367  Kuwaiti Government.
EX2012100771............          UN0367  Kuwaiti Government.
EX2012101234............          UN0367  Kuwaiti Government.
EX2012101307............          UN0367  Kuwaiti Government
EX2012110071............          UN0367  Kuwaiti Government.
EX2012121019............          UN0367  Kuwaiti Government.
EX2012121020............          UN0367  Kuwaiti Government.
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------------------------------------------------------------------------

    Issued in Washington, DC, on June 7, 2023.
William S. Schoonover,
Associate Administrator for Hazardous Materials Safety, Pipeline and
Hazardous Materials Safety Administration.
[FR Doc. 2023-12728 Filed 6-13-23; 8:45 am]
BILLING CODE 4910-60-P


UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, D.C.

Issued by the Department of Transportation on April 17, 2006

NOTICE OF ACTION TAKEN -- DOCKET OST-1999-5708

________________________________________________________________________
________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant: ABACO AIR LTD.  (Abaco)					Date Filed:  March 28, 2006

Relief requested:  Exemption from 49 USC § 41301 to permit the
applicant to conduct charter foreign air transportation of persons,
property, and mail between the Bahamas and Florida, using small
equipment.

Applicant representative:  Denise D. Kelly,<PHONE_NUMBER>	DOT analyst:
Robert J. Finamore,<PHONE_NUMBER>

Responsive pleadings:  None.

	DISPOSITION

Action:  Approved.
                                     Action date:  April 17, 2006

Effective dates of authority granted:  April 17, 2006, through April 17,
2007.

Basis for approval (bilateral agreement/reciprocity): Reciprocity with
the Bahamas.

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations of our standard exemption conditions
(attached).

Special conditions/Remarks:  In the conduct of these operations, the
applicant may only use aircraft designed to have a maximum passenger
capacity of not more than 60 seats and a maximum payload capacity of not
more than 18,000 pounds.

Action taken by:   Paul L. Gretch, Director, Office of International
Aviation

________________________________________________________________________
________________________________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) the applicant was qualified to perform its proposed
operations; (3) grant of the authority was consistent with the public
interest; and (4) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted/deferred/dismissed, we denied all requests in
the referenced Docket.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp

FOREIGN CARRIER EXEMPTION CONDITIONS
                              ATTACHMENT

In the conduct of the operations authorized, the foreign carrier
applicant(s) shall:

1) Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

2) Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security, including, but not limited to, 49 CFR Part 1546 or 1550, as
applicable.  To assure compliance with all applicable U.S. Government
requirements concerning security, the holder shall, before commencing
any new service (including charter flights) from a foreign airport that
would be the holder’s last point of departure for the United States,
contact its International Principal Security Inspector (IPSI) to advise
the IPSI of its plans and to find out whether the Transportation
Security Administration has determined that security is adequate to
allow such airport(s) to be served;

3) Comply with the requirements for minimum insurance coverage contained
in 14 CFR Part 205, and, prior to the commencement of any operations
under this authority, file evidence of such coverage, in the form of a
completed OST Form 6411, with the Federal Aviation Administration’s
Program Management Branch (AFS-260), Flight Standards Service (any
changes to, or termination of, insurance also shall be filed with that
office);

4) Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

5) Conform to the airworthiness and airman competency requirements of
its Government for international air services;

6) Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR Part 203,
concerning waiver of Warsaw Convention liability limits and defenses;

7) Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are: a) based on its
operations in international air transportation that, according to the
contract of carriage, include a point in the United States as a point of
origin, point of destination, or agreed stopping place, or for which the
contract of carriage was purchased in the United States; or b) based on
a claim under any international agreement or treaty cognizable in any
court or other tribunal of the United States.  In this condition, the
term “international air transportation” means “international
transportation” as defined by the Warsaw Convention, except that all
States shall be considered to be High Contracting Parties for the
purpose of this definition;

8) Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

9) Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department’s
rules governing charters (including 14 CFR Parts 212 and 380); and

11) Comply with such other reasonable terms, conditions, and limitations
required by the public interest as may be prescribed by the Department,
with all applicable orders or regulations of other U.S. agencies and
courts, and with all applicable laws of the United States.

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code.

 05/2004

 Abaco styled its request in the captioned Docket as a renewal request.
We note, however, that the applicant’s previous authority in this
Docket had lapsed.  Our action here thus does not in fact constitute a
renewal.


[Federal Register Volume 86, Number 145 (Monday, August 2, 2021)]
[Notices]
[Pages 41483-41486]
[FR Doc No: 2021-16350]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0658]

Vithal K. Patel; 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 Vithal K. Patel (Mr. Patel) and issuing an
order under the Federal Food, Drug, and Cosmetic Act (FD&C Act)
debarring Mr. Patel for 1 year 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 Mr. Patel was convicted of
conspiracy to commit a felony under Federal law for conduct relating to
the regulation of drug products under the FD&C Act and that the type of
conduct underlying the conviction undermined the process for the
regulation of drugs. In determining the appropriateness and period of
Mr. Patel's debarment, FDA considered the relevant factors listed in
the FD&C Act. Mr. Patel has failed to file with the Agency information
and analyses sufficient to create a basis for a hearing concerning this
action.

DATES: This order is applicable August 2, 2021.

ADDRESSES: Any application for termination of debarment by Mr. Patel
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: All applications must include the Docket No. FDA-
2011-N-0658. Received applications will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     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.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket, go to https://www.regulations.gov
and insert the docket number, found in brackets in the heading of this
document, into the ``Search'' box and follow the prompts and/or go to
the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852 between 9 a.m. and 4 p.m., Monday through Friday, 240-402-
7500. Publicly available submissions may be seen in the docket.

FOR FURTHER INFORMATION CONTACT: Rachael Vieder Linowes, Office of
Scientific Integrity, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 4206, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(b)(2)(B)(i)(II) of the FD&C Act (21 U.S.C.
335a(b)(2)(B)(i)(II)) permits FDA to debar an individual if it finds:
(1) That the individual has been convicted of a conspiracy to commit a
felony under Federal law for conduct relating to the regulation of any
drug product under the FD&C Act and (2) that the type of conduct
serving as the basis of the conviction undermines the process for the
regulation of drugs.
    On August 7, 2007, Mr. Patel pled guilty to a felony count of
conspiracy to distribute misbranded and adulterated drugs in violation
of 18 U.S.C. 371. On December 16, 2010, the U.S. District Court for the
District of New Jersey entered the conviction, sentenced Mr. Patel to 2
years of probation, and imposed a $3,000 fine. Mr. Patel's conviction
stemmed from his employment at Able Laboratories, Inc. (Able), where he
was a Research and Development Manager and later the Associate Director
for Technical Service. Mr. Patel and others conspired to cause the
introduction of misbranded and adulterated drugs into interstate
commerce with the intent to defraud and mislead the United States, in
violation of sections 301(a) and 303(a)(2) of the FD&C Act (21 U.S.C.
331(a) and 333(a)(2)). According to the criminal information to which
he pled guilty under a plea agreement, Mr. Patel and his coconspirators
agreed to violate FDA's regulations regarding good manufacturing
practice for drugs by, among other things, manipulating and falsifying
testing data and information. Mr. Patel specifically admitted to an
overt act in furtherance of the conspiracy, namely supervising the
manipulation of the process for manufacturing promethazine, a
prescription antihistamine medication.
    By letter dated January 6, 2012, FDA's Office of Regulatory Affairs
(ORA) notified Mr. Patel of an opportunity for a hearing on a proposal
to debar him for 5 years from providing services in any capacity to a
person having an approved or pending drug product application. In its
proposal, ORA concluded that Mr. Patel should be debarred for 5 years
based on four applicable considerations in section 306(c)(3) of the
FD&C Act: (1) The nature and seriousness of his offense, (2) the nature
and extent of management participation in the offense, (3) the nature
and extent of voluntary steps taken to mitigate the impact on the
public, and (4) prior convictions involving matters within FDA's
jurisdiction. ORA found that the first three of those considerations
weigh in favor of debarment and noted, as to the fourth consideration,
that FDA is unaware of any prior convictions.
    In a letter dated March 8, 2012, Mr. Patel requested a hearing on
the proposal and submitted materials and arguments in support of his
request. In his submission, Mr. Patel acknowledges his conviction of a
conspiracy to commit a felony under Federal law and does not dispute
that the conduct underlying that conviction related to the regulation
of a drug product or that conduct of that type undermines the process
for the regulation of drugs. He argues, however, that with respect to
the considerations for determining the appropriateness and period of
debarment under section 306(c)(3) of the FD&C Act, there are genuine
and substantial issues of fact for resolution at a hearing.

II. Statutory and Regulatory Framework Regarding Part 12 Hearings

    Under the authority delegated by the Commissioner of Food and
Drugs, the Chief Scientist has considered Mr. Patel's submission. Under
Sec.  12.24(a)(2) (21 CFR 12.24(a)(2)), the Agency reviews a hearing
request to determine whether a hearing is justified. FDA has the
authority to deny a hearing when it appears from the hearing request
that there are no material disputes of fact. See Costle v. Pacific
Legal Found., 445 U.S. 198, 214 (1980) (a party seeking a hearing is
required to meet a ``threshold burden of tendering evidence suggesting
the need for a hearing''), reh'g denied, 446 U.S. 947 (1980), citing
Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 620-21
(1973); Pineapple Growers Ass'n v. FDA, 673 F.2d 1083, 1085-86 (9th
Cir. 1982) (holding that no hearing is necessary unless ``material
issues of fact'' have been raised).
    In determining whether there are material issues of fact suitable
for a hearing, FDA considers the specific criteria set out in Sec.
12.24(b) and grants a hearing only if the material submitted in support
of the request shows the following: (1) There is a genuine and
substantial factual issue for resolution at a hearing; a hearing will
not be granted on issues of policy or law; (2) the factual issue can be
resolved by available and specifically identified reliable evidence; a
hearing will not be granted on the basis of mere allegations or denials
or general descriptions of positions and contentions; (3) the data and
information submitted, if established at a hearing, would be adequate
to justify resolution of the factual issue in the way sought by the
requestor; a hearing will be denied if the Agency concludes that the
data and information submitted are insufficient to justify the factual
determination urged, even if accurate; (4) resolution of the factual
issue in the way sought by the person is adequate to justify the action
requested; a hearing will not be granted on factual issues that are not
determinative with respect to the action requested (e.g., if the Agency
concludes that the action would be the same even if the factual issue
were resolved in the way sought); (5) the action requested is not
inconsistent with any provision in the FD&C Act or any FDA regulation;
and (6) the requirements in other applicable regulations, e.g., 21 CFR
10.20, 12.21, and 12.22, and in the notice of an opportunity for
hearing are met.

III. Arguments

    In his request for a hearing, Mr. Patel challenges ORA's findings
with respect to the three considerations that it concluded weighed in
favor of his debarment. Mr. Patel also contends that there are two
additional considerations under section 306(c)(3) of the FD&C Act that
were not considered by ORA and should weigh in his favor against
debarment. Section 306(c)(3) of the FD&C Act explicitly requires that
FDA consider, ``where applicable,'' certain factors ``[i]n determining
the appropriateness and the period of debarment'' for any permissive
debarment.

A. Nature and Seriousness of the Offense

    Regarding the nature and seriousness of his offense, Mr. Patel
contends that, in reaching its conclusion regarding the nature and
seriousness of his felony

offense, ORA failed to consider certain important facts. Specifically,
Mr. Patel argues that the overt act underlying his conspiracy
conviction--namely supervising manipulation of the process for
manufacturing promethazine--involved merely failing to document or
follow proper procedures for a nitrogen flush and ``posed no danger to
the end users, the public at large, or coworkers at Able.'' He reasons
that, ``as an inert gas, nitrogen could not possibly interact with the
[promethazine hydrochloride] in any way.'' Mr. Patel maintains that
this factor should therefore not have weighed in favor of his
debarment. However, as part of his guilty plea, Mr. Patel admitted to
conspiring to cause the introduction of misbranded and adulterated
products into interstate commerce, with the intent to defraud and
mislead the United States. Therefore, even assuming that Mr. Patel did
not intend for his conduct to harm anyone, the offense to which Mr.
Patel pled guilty remains serious and weighs in favor of debarment.

B. Nature and Extent of Management Participation in the Offense

    As to the consideration addressing the nature and extent of
management participation, Mr. Patel argues that ORA's analysis
overlooks the nature and extent of Mr. Patel's management participation
in the offense and reaches the conclusion that this factor is
unfavorable ``simply because Mr. Patel was not an entry level worker.''
In fact, Mr. Patel insists that he ``never participated in the
production of commercial products at Able Labs'' and, as such,
``exercised no `management' authority in connection with the nitrogen
flush'' and ``had no input into or control over Able Labs' `corporate
policies and practices' or `institutional controls' with respect to
production processes.'' To the contrary, Mr. Patel emphasizes that
``both the United States Attorney's Office and [the court] confirmed
that Mr. Patel was acting on the order of his superior managers to
observe the nitrogen flush and was in fear the he would be terminated
if he refused.''

    In the proposal to debar, ORA stated:
    As a Research and Development Manager and Associate Director of
Technical Service, you were responsible for supervising numerous
chemists and technicians who manufactured test batches to ensure
product safety and effectiveness. Your management position also
entailed monitoring the chemists' compliance with GMPs, as required
by FDA, and SOPs established by the company and ensuring compliance
with Able's SOPs, including protocols for investigating, logging,
and archiving any aberrant, deviant, or failing analytical
laboratory results. As supervisor, you held a position of authority
in which your conduct served as an example to other employees.
Accordingly, the Agency will consider this an unfavorable factor.

    Mr. Patel does not dispute that he was in a supervisory position at
Able. Even assuming Mr. Patel reasonably feared termination related to
the conspiracy he joined, Mr. Patel does not contest that he worked in
a position of authority at Able and had the responsibilities outlined
in ORA's proposal to debar him for 5 years. Therefore, Mr. Patel has
failed to create an issue for hearing with respect to whether the
nature and extent of his management participation in the offense should
weigh against debarment.

C. Changes in Ownership, Management, or Operations

    Next, Mr. Patel argues that ORA incorrectly failed to consider
``whether the extent to which changes in ownership, management, or
operations have corrected the causes of any offense involved and
provide reasonable assurances that the offense will not occur in the
future,'' under section 306(c)(3)(D) of the FD&C Act. Mr. Patel states
that an offense will not occur here in the future because ``Able Labs
is now defunct'' and he ``voluntarily left the pharmaceutical industry
in 2007.''
    FDA must consider, where applicable, ``whether the extent to which
changes in ownership, management, or operations have corrected the
causes of any offense involved and provide reasonable assurances that
the offense will not occur in the future.'' 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. This consideration 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 for the sake of
argument 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, Mr. Patel's contention that, because he
voluntarily left the pharmaceutical industry he has provided reasonable
assurances that he will not commit the offense again given the
opportunity, fails to create a genuine and substantial issue of fact
that warrants a hearing. Furthermore, given that this debarment
proceeding focuses on Mr. Patel rather than Able, it is immaterial that
Able Labs is no longer in business.

D. Abbreviated New Drug Applications (ANDAs)

    Mr. Patel argues that ``whether the person to be debarred is able
to present adequate evidence that current production of drugs subject
to abbreviated drug applications and all pending abbreviated drug
applications are free of fraud or material false statements'' under
section 306(c)(3)(E) of the FD&C Act should be considered in his favor
because the improper manufacturing procedures for which Mr. Patel was
convicted ``had no relation to a drug application in any way.'' This
factor is only relevant for persons that have an ANDA. Mr. Patel has
not presented any evidence that he has any existing abbreviated drug
applications for consideration in his own name, and thus, this factor
is not relevant in determining the appropriateness and length of
debarment and fails to create a genuine and substantial issue of fact
that warrants a hearing.

E. Nature and Extent of Voluntary Steps To Mitigate

    Lastly, under section 306(c)(3)(C) of the FD&C Act, in determining
the appropriateness and period of debarment, FDA must consider, where
applicable, ``the nature and extent of voluntary steps to mitigate the
effect on the public,'' including whether the person took specified
corrective actions after the criminal violation or fully cooperated
with any investigations. In the proposal to debar, ORA concluded that
Mr. Patel's ``failure to take voluntary steps to mitigate the offense
[he] committed'' rendered this an unfavorable factor. ORA based this
conclusion on the fact that ``FDA has no information demonstrating that
[Mr. Patel] took any voluntary steps to mitigate the impact of [his]
actions on the public.''
    In his hearing request, Mr. Patel maintains that he did, in fact,
take voluntary steps to mitigate the effect of his offense on the
public, including ``full cooperation with any investigations'' under
section 306(c)(3)(C) of the FD&C Act. In support, Mr. Patel submits a
letter from an Assistant U.S. Attorney who participated in his
prosecution and a transcript of his sentencing. Quoting this letter,
Mr. Patel maintains that his cooperation enabled the Government to
``expand its investigation to other individuals and to develop a better
understanding of the misbranding conspiracy at Able Labs'' and
``permitted the government to vet the information . . . received from
other

individuals and to follow new leads.'' Furthermore, he adds that he
provided valuable ``details about events and discussions demonstrating
that Able Labs' management had made changes to drug protocols.'' He
relies on these submissions to demonstrate not only that he cooperated
with the government and contributed to the successful prosecution of
others, including Able's top manager, but also that the government
argued at his sentencing that he provided ``substantial assistance'' in
those investigations and moved for a more lenient sentence on that
basis. Mr. Patel's account of his cooperation and substantial
assistance in the investigation is undisputed and supported by the
transcript of his sentencing. Therefore, the nature and extent of the
voluntary steps Mr. Patel took to mitigate the impact of his offense on
the public under section 306(c)(3)(C) of the FD&C Act weigh in Mr.
Patel's favor in determining the appropriateness and period of
debarment.
    Given the undisputed facts described above, and after considering
the applicable factors listed in section 306(c)(3) of the FD&C Act, the
Chief Scientist finds that Mr. Patel's conviction warrants a 1-year
debarment period. It is undisputed that Mr. Patel pled guilty to a
serious offense and that he participated in the offense as a
supervisor. However, Mr. Patel took significant steps to mitigate the
effect of his offense on the public, as described in the Assistant U.S.
Attorney's letter, and he has no prior convictions. Particularly in
light of FDA's strong public policy interest in encouraging cooperation
with authorities engaged in investigating wrongdoing related to the
Agency's regulation of drugs, as reflected in section 306(c)(3)(C) of
the FD&C Act, the Chief Scientist has determined that a debarment
period of only 1 year is appropriate in this case.

IV. Findings and Order

    Therefore, the Chief Scientist, under section 306(b)(2)(B)(i)(II)
of the FD&C Act and under authority delegated to her by the
Commissioner of Food and Drugs, finds that: (1) Mr. Patel has been
convicted of a conspiracy to commit a felony under Federal law for
conduct relating to the regulation of a drug product under the FD&C Act
and (2) that 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 1 year is appropriate.
    As a result of the foregoing findings, Mr. Patel is debarred for 1
year from providing services in any capacity to a person with an
approved or pending drug product application under sections 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 August
2, 2021 (see 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 Mr. Patel, 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 Mr. Patel, 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 Mr. Patel during his period of debarment (section
306(c)(1)(B) of the FD&C Act).

    Dated: July 27, 2021.
Denise Hinton,
Chief Scientist.
[FR Doc. 2021-16350 Filed 7-30-21; 8:45 am]
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[Federal Register Volume 79, Number 32 (Tuesday, February 18, 2014)]
[Notices]
[Page 9229]
[FR Doc No: 2014-03454]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]

Food and Drug Administration/Xavier University PharmaLink
Conference--Leadership in a Global Supply Chain

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference.

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

    The Food and Drug Administration (FDA) Cincinnati District, in
cosponsorship with Xavier University, is announcing a public conference
entitled ``FDA/Xavier University PharmaLink Conference: Leadership in a
Global Supply Chain.'' The public conference seeks solutions to
important and complicated issues by aligning with the strategic
priorities of FDA, and includes presentations from key FDA officials,
global regulators, and industry experts. Each presentation challenges
the status quo and conventional wisdom to create synergies focused on
finding solutions which make a difference. The experience level of the
audience has fostered engaged dialog that has led to innovative
initiatives.
    Dates and Times: The public conference will be held on March 19 and
20, 2014, from 8:30 a.m. to 5 p.m. and March 21, 2014, from 8:30 a.m.
to 12:15 p.m.
    Location: The public conference will be held on the campus of
Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-
3073 or<PHONE_NUMBER>.
    Contact Persons:
    For information regarding this notice: Steven Eastham, Food and
Drug Administration, Cincinnati South Office, 36 East 7th Street,
Cincinnati, OH, 45202,<PHONE_NUMBER>, email<EMAIL_ADDRESS>    For information regarding the conference and registration: Marla
Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207,
513-745-3073, email<EMAIL_ADDRESS>    Registration: There is a registration fee. The conference
registration fees cover the cost of the presentations, training
materials, receptions, breakfasts, lunches, and dinners for the 2 1/2
days of the conference. There will be onsite registration. The cost of
registration is as follows:

                     Table1.--Registration Fees \1\
------------------------------------------------------------------------
                                                           Registration
                      Attendee type                            fees
------------------------------------------------------------------------
Industry................................................          $1,895
Small Business (<100 employees).........................          $1,295
Startup Manufacturer....................................            $300
Academic................................................            $300
Media...................................................            Free
Government..............................................            Free
------------------------------------------------------------------------
\1\ The fourth registration from the same company is free--all four
  attendees must register at the same time.

    The following forms of payment will be accepted: American Express,
Visa, Mastercard, and company checks.

    To register online for the public conference, please visit the
``Registration'' link on the conference Web site at http://www.XavierPharmaLink.com. FDA has verified the Web site address, but is
not responsible for subsequent changes to the Web site after this
document publishes in the Federal Register.
    To register by mail, please send your name, title, firm name,
address, telephone and fax numbers, email, and payment information for
the fee to Xavier University, Attention: Matty Toomb, 3800 Victory
Pkwy., Cincinnati, OH 45207. An email will be sent confirming your
registration.
    Attendees are responsible for their own accommodations. The
conference headquarter hotel is the Downtown Cincinnati Hilton
Netherlands Plaza, 35 West 5th Street, Cincinnati, OH 45202, 513-421-
9100. To make reservations online, please visit the ``Venue &
Logistics'' link at http://www.XavierPharmaLink.com. The hotel is
expected to sellout during this timeframe, so early reservation in the
conference room-block is encouraged.
    If you need special accommodations due to a disability, please
contact Marla Phillips (see Contact Persons) at least 7 days in advance
of the conference.

SUPPLEMENTARY INFORMATION:  The public conference helps fulfill the
Department of Health and Human Services and FDA's important mission to
protect the public health. The conference will engage those involved in
FDA-regulated global supply chain quality and management through the
following topics:

     The Impact of ``The CDER Challenge'' to Industry
     FDA and the Medicines and Healthcare Products Regulatory
Agency (MHRA) Investigator Insights
     Operationalizing Effective Contract Partnerships
     Comparing Metrics with Other Companies--is There a Way?
Why is it Vital?
     Complex Supply Chain Development
     The FDA Safety and Innovation Act (FDASIA): The New
Frontier
     Why Your Incoming Supply is Not Reliable--Shifting
Paradigms
     Innovation Versus Safety--The Impact of the Center for
Drug Evaluation and Research's Restructure
     MHRA Perspective on Global Supply Chain Challenges
     How Did They Do That? Learn from Other Industries!
    The conference includes:
     Networking by topic
     Case studies
     Small group discussions
     Action plans
     Keynote dinner at the Cincinnati Reds Baseball Stadium
with the Chief Executive Officer of Patheon, James Mullen
    The most pressing challenges of the global pharmaceutical industry
require solutions which are inspired by collaboration to ensure the
ongoing health and safety of patients. These challenges include
designing products with the patient in mind, building quality into the
product from the onset, selecting the right suppliers, and considering
total product life-cycle systems. Meeting these challenges requires
vigilance, innovation, supply chain strategy, relationship management,
proactive change management, and a commitment to doing the job right
the first time. FDA has made education of the drug and device
manufacturing community a high priority to help ensure the quality of
FDA-regulated drugs and devices.
    The conference helps to achieve objectives set forth in section 406
of the Food and Drug Administration Modernization Act of 1997 (21
U.S.C. 393), which includes working closely with stakeholders and
maximizing the availability and clarity of information to stakeholders
and the public. The conference also is consistent with the Small
Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121)
by providing outreach activities by Government Agencies to small
businesses.

    Dated: February 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03454 Filed 2-14-14; 8:45 am]
BILLING CODE 4160-01-P