[Federal Register Volume 85, Number 193 (Monday, October 5, 2020)]
[Notices]
[Pages 62795-62797]
[FR Doc No: 2020-21899]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2014-0212; FMCSA-2014-0215; FMCSA-2018-0053; FMCSA-
2018-0054]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of renewal of exemptions; request for comments.

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SUMMARY: FMCSA announces its decision to renew exemptions for six
individuals from the requirement in the Federal Motor Carrier Safety
Regulations (FMCSRs) that interstate commercial motor vehicle (CMV)
drivers have ``no established medical history or clinical diagnosis of
epilepsy or any other condition which is likely to cause loss of
consciousness or any loss of ability to control a CMV.'' The exemptions
enable these individuals who have had one or more seizures and are
taking anti-seizure medication to continue to operate CMVs in
interstate commerce.

DATES: Each group of renewed exemptions were applicable on the dates
stated in the discussions below and will expire on the dates stated in
the discussions below. Comments must

be received on or before November 4, 2020.

ADDRESSES: You may submit comments identified by the Federal Docket
Management System (FDMS) Docket No. FMCSA-2014-0212, Docket No. FMCSA-
2014-0215, Docket No. FMCSA-2018-0053, or Docket No. FMCSA-2018-0054
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Operations; U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m.,
ET, Monday through Friday, except Federal Holidays.
     Fax:<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation'' portion of the SUPPLEMENTARY
INFORMATION section for instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
ET, Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Docket Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Submitting Comments

    If you submit a comment, please include the docket number for this
notice (Docket No. FMCSA-2014-0212, FMCSA-2014-0215, FMCSA-2018-0053,
or FMCSA-2018-0054), indicate the specific section of this document to
which each comment applies, and provide a reason for each suggestion or
recommendation. You may submit your comments and material online or by
fax, mail, or hand delivery, but please use only one of these means.
FMCSA recommends that you include your name and a mailing address, an
email address, or a phone number in the body of your document so that
FMCSA can contact you if there are questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
put the docket number, FMCSA-2014-0212, FMCSA-2014-0215, FMCSA-2018-
0053, or FMCSA-2018-0054, in the keyword box, and click ``Search.''
When the new screen appears, click on the ``Comment Now!'' button and
type your comment into the text box on the following screen. Choose
whether you are submitting your comment as an individual or on behalf
of a third party and then submit.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the facility, please enclose a stamped,
self-addressed postcard or envelope.
    FMCSA will consider all comments and material received during the
comment period.

B. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov.
Insert the docket number, FMCSA-2014-0212, FMCSA-2014-0215, FMCSA-2018-
0053, or FMCSA-2018-0054 in the keyword box, and click ``Search.''
Next, click the ``Open Docket Folder'' button and choose the document
to review. If you do not have access to the internet, you may view the
docket online by visiting Docket Operations in Room W12-140 on the
ground floor of the DOT West Building, 1200 New Jersey Avenue SE,
Washington, DC 20590, between 9 a.m. and 5 p.m., ET, Monday through
Friday, except Federal holidays. To be sure someone is there to help
you, please call<PHONE_NUMBER> or<PHONE_NUMBER> before visiting
Docket Operations.

C. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.transportation.gov/privacy.

II. Background

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-year period if it finds such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption. The statute also allows the Agency to renew exemptions at
the end of the 5-year period. FMCSA grants medical exemptions from the
FMCSRs for a 2-year period to align with the maximum duration of a
driver's medical certification.
    The physical qualification standard for drivers regarding epilepsy
found in 49 CFR 391.41(b)(8) states that a person is physically
qualified to drive a CMV if that person has no established medical
history or clinical diagnosis of epilepsy or any other condition which
is likely to cause the loss of consciousness or any loss of ability to
control a CMV.
    In addition to the regulations, FMCSA has published advisory
criteria \1\ to assist medical examiners (MEs) in determining whether
drivers with certain medical conditions are qualified to operate a CMV
in interstate commerce.
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    \1\ These criteria may be found in APPENDIX A TO PART 391--
MEDICAL ADVISORY CRITERIA, section H. Epilepsy: Sec.  391.41(b)(8),
paragraphs 3, 4, and 5, which is available on the internet at
https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.
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    The six individuals listed in this notice have requested renewal of
their exemptions from the epilepsy and seizure disorders prohibition in
Sec.  391.41(b)(8), in accordance with FMCSA procedures. Accordingly,
FMCSA has evaluated these applications for renewal on their merits and
decided to extend each exemption for a renewable 2-year period.

III. Request for Comments

    Interested parties or organizations possessing information that
would otherwise show that any, or all, of these drivers are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is being compromised or if continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315(b), FMCSA will take immediate steps to revoke the
exemption of a driver.

IV. Basis for Renewing Exemptions

    In accordance with 49 U.S.C. 31136(e) and 31315(b), each of the six
applicants has satisfied the renewal conditions for obtaining an
exemption from the epilepsy and seizure disorders prohibition. The six
drivers in this notice remain in good standing with the Agency, have
maintained their medical monitoring and have not exhibited any medical
issues that would compromise their ability to safely operate a CMV
during the previous 2-year exemption

period. In addition, for Commercial Driver's License (CDL) holders, the
Commercial Driver's License Information System and the Motor Carrier
Management Information System are searched for crash and violation
data. For non-CDL holders, the Agency reviews the driving records from
the State Driver's Licensing Agency. These factors provide an adequate
basis for predicting each driver's ability to continue to safely
operate a CMV in interstate commerce. Therefore, FMCSA concludes that
extending the exemption for each renewal applicant for a period of 2
years is likely to achieve a level of safety equal to that existing
without the exemption.
    In accordance with 49 U.S.C. 31136(e) and 31315(b), the following
groups of drivers received renewed exemptions in the month of October
and are discussed below.
    As of October 15, 2020, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), the following four individuals have satisfied the renewal
conditions for obtaining an exemption from the epilepsy and seizure
disorders prohibition in the FMCSRs for interstate CMV drivers:

Ricky B. Alegre (NJ)
Thomas Avery, Jr. (NY)
Peter Bender (MN)
Alan Von Lintel (KS)

    The drivers were included in docket number FMCSA-2014-0212, FMCSA-
2014-0215, and FMCSA-2018-0053. Their exemptions are applicable as of
October 15, 2020, and will expire on October 15, 2022.
    As of October 17, 2020, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), the following two individuals have satisfied the renewal
conditions for obtaining an exemption from the epilepsy and seizure
disorders prohibition in the FMCSRs for interstate CMV drivers:

Jose Lara-Ramirez (NV) and Bryan Sheehan (FL)

    The drivers were included in docket number FMCSA-2018-0054. Their
exemptions are applicable as of October 17, 2020, and will expire on
October 17, 2022.

V. Conditions and Requirements

    The exemptions are extended subject to the following conditions:
(1) Each driver must remain seizure-free and maintain a stable
treatment during the 2-year exemption period; (2) each driver must
submit annual reports from their treating physicians attesting to the
stability of treatment and that the driver has remained seizure-free;
(3) each driver must undergo an annual medical examination by a
certified ME, as defined by Sec.  390.5; and (4) each driver must
provide a copy of the annual medical certification to the employer for
retention in the driver's qualification file, or keep a copy of his/her
driver's qualification file if he/she is self-employed. The driver must
also have a copy of the exemption when driving, for presentation to a
duly authorized Federal, State, or local enforcement official. The
exemption will be rescinded if: (1) The person fails to comply with the
terms and conditions of the exemption; (2) the exemption has resulted
in a lower level of safety than was maintained before it was granted;
or (3) continuation of the exemption would not be consistent with the
goals and objectives of 49 U.S.C. 31136(e) and 31315(b).

VI. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VII. Conclusion

    Based on its evaluation of the six exemption applications, FMCSA
renews the exemptions of the aforementioned drivers from the epilepsy
and seizure disorders prohibition in Sec.  391.41(b)(8). In accordance
with 49 U.S.C. 31136(e) and 31315(b), each exemption will be valid for
2 years unless revoked earlier by FMCSA.

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2020-21899 Filed 10-2-20; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 79, Number 4 (Tuesday, January 7, 2014)]
[Notices]
[Pages 820-821]
[FR Doc No: 2014-00011]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings  1

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-1851-003; ER10-1976-004; ER10-1966-004; ER10-
1985-004; ER11-4462-006; ER10-1971-013; ER10-1930-003; ER10-1931-004;
ER12-2225-003; ER12-2226-003.
    Applicants: ESI Vansycle Partners, L.P., FPL Energy Stateline II,
Inc., FPL Energy Vansycle, L.L.C., Limon Wind, LLC, Limon Wind II, LLC,
Logan Wind Energy LLC, Northern Colorado Wind Energy, LLC, Peetz Table
Wind Energy, LLC, NextEra Energy Power Marketing, LLC, NEPM II, LLC.
    Description: Triennial Market Power Update for Northwest Region of
the NextEra Companies.
    Filed Date: 12/23/13.
    Accession Number: 20131223-5276.
    Comments Due: 5 p.m. ET 2/21/14.

    Docket Numbers: ER10-1910-004; ER10-1908-004; ER10-1909-004; ER10-
1911-004.
    Applicants: Duquesne Conemaugh LLC, Duquesne Keystone LLC, Duquesne
Light Company, Duquesne Power, LLC.
    Description: Notice of Non-Material Change in Status of the
Duquesne Utilities.
    Filed Date: 12/27/13.
    Accession Number: 20131227-5155.
    Comments Due: 5 p.m. ET 1/17/14.

    Docket Numbers: ER10-2132-005.
    Applicants: Willow Creek Energy LLC.
    Description: Triennial Report for Northwest Region Willow Creek
Energy LLC.
    Filed Date: 12/30/13.
    Accession Number: 20131230-5035.
    Comments Due: 5 p.m. ET 2/28/14.

    Docket Numbers: ER10-2763-009; ER10-2759-003; ER10-2732-009; ER10-
2736-009; ER10-2737-009; ER10-2741-009; ER10-2749-009; ER10-2752-009;
ER12-2492-005; ER12-2493-005; ER12-2494-005; ER12-2495-005; ER12-2496-
005; ER10-2733-009; ER10-2734-009; ER10-2631-003; ER13-815-001.
    Applicants: Bangor Hydro Electric Company, Bridgeport Energy LLC,
Emera Energy Services Inc., Emera Energy Services Subsidiary No. 1 LLC,
Emera Energy Services Subsidiary No. 2 LLC, Emera Energy Services
Subsidiary No. 3 LLC, Emera Energy Services Subsidiary No. 4 LLC, Emera
Energy Services Subsidiary No. 5 LLC, Emera Energy Services Subsidiary
No. 6 LLC, Emera Energy Services Subsidiary No. 7 LLC, Emera Energy
Services Subsidiary

No. 8 LLC, Emera Energy Services Subsidiary No. 9 LLC, Emera Energy
Services Subsidiary No. 10 LLC, Emera Energy U.S. Subsidiary No. 1,
Inc., Emera Energy U.S. Subsidiary No. 2, Inc., Rumford Power
Inc.,Tiverton Power LLC.
    Description: Triennial Market Power Update for Northeast Region and
Notice of Two Changes in Status of the Emera Entities.
    Filed Date: 12/30/13.
    Accession Number: 20131230-5031.
    Comments Due: 5 p.m. ET 2/28/14.

    Docket Numbers: ER10-2764-005.
    Applicants: Vantage Wind Energy LLC.
    Description: Triennial Report for Northwest Region and Notice of
Change in Facts of Vantage Wind Energy LLC.
    Filed Date: 12/30/13.
    Accession Number: 20131230-5033.
    Comments Due: 5 p.m. ET 2/28/14.

    Docket Numbers: ER12-1179-015.
    Applicants: Southwest Power Pool, Inc.
    Description: Certification of Readiness to Implement the Integrated
Marketplace by Southwest Power Pool, Inc.
    Filed Date: 12/27/13.
    Accession Number: 20131227-5153.
    Comments Due: 5 p.m. ET 1/17/14.

    Docket Numbers: ER13-136-002; ER10-2418-002; ER13-135-002; ER13-
137-002; ER13-138-002; ER13-140-002; ER13-148-002; ER13-147-002; ER13-
141-002; ER13-142-002; ER13-144-002; ER13-146-002; ER13-145-002.
    Applicants: Georgia-Pacific Brewton LLC, GP Big Island, LLC,
Brunswick Cellulose LLC, Georgia-Pacific Cedar Springs LLC, Georgia-
Pacific Consumer Operations, LLC, Palatka, Georgia-Pacific Consumer
Operations, LLC, Port Hudson, Georgia-Pacific Consumer Products, LP,
Green Bay West, Georgia-Pacific Consumer Products, LP, Muskogee,
Georgia-Pacific Consumer Products, LP, Naheola, Georgia-Pacific
Consumer Products, LP, Savannah, Georgia-Pacific Monticello LLC,
Georgia-Pacific Toledo LLC, Leaf River Cellulose, LLC.
    Description: Notice of Non-Material Change in Status of the
Georgia-Pacific Entities.
    Filed Date: 12/27/13.
    Accession Number: 20131227-5163.
    Comments Due: 5 p.m. ET 1/17/14.

    Docket Numbers: ER13-1896-004.
    Applicants: AEP Generation Resources Inc.
    Description: AEP Generation Resources Inc. submits AEP Gen
Resources MBR Revision to be effective 3/1/2014.
    Filed Date: 12/27/13.
    Accession Number: 20131227-5127.
    Comments Due: 5 p.m. ET 1/17/14.

    Docket Numbers: ER14-594-001.
    Applicants: Ohio Power Company.
    Description: Ohio Power Company submits Ohio Power MBR Revision to
be effective 3/1/2014.
    Filed Date: 12/27/13.
    Accession Number: 20131227-5126.
    Comments Due: 5 p.m. ET 1/17/14.

    Docket Numbers: ER14-870-000.
    Applicants: Appalachian Power Company.
    Description: Appalachian Power Company submits AEP Operating
Companies MBR Revision to be effective 3/1/2014.
    Filed Date: 12/27/13.
    Accession Number: 20131227-5124.
    Comments Due: 5 p.m. ET 1/17/14.

    Docket Numbers: ER14-871-000.
    Applicants: AEP Energy Partners, Inc.
    Description: AEP Energy Partners, Inc. submits AEP Energy Partners
MBR Revision to be effective 3/1/2014.
    Filed Date: 12/27/13.
    Accession Number: 20131227-5125.
    Comments Due: 5 p.m. ET 1/17/14.

    Docket Numbers: ER14-872-000.
    Applicants: CSW Energy Services, Inc.
    Description: CSW Energy Services, Inc. submits CSW Energy Services
MBR Revision to be effective 3/1/2014.
    Filed Date: 12/27/13.
    Accession Number: 20131227-5128.
    Comments Due: 5 p.m. ET 1/17/14.

    Docket Numbers: ER14-873-000.
    Applicants: Calpine New Jersey Generation, LLC.
    Description: Calpine New Jersey Generation, LLC submits Notice of
Succession, Reactive Rate Schedule to be effective 12/27/2013.
    Filed Date: 12/27/13.
    Accession Number: 20131227-5129.
    Comments Due: 5 p.m. ET 1/17/14.

    Docket Numbers: ER14-874-000.
    Applicants: Calpine Bethlehem, LLC.
    Description: Calpine Bethlehem, LLC submits Notice of Succession,
Reactive Rate Schedule to be effective 12/27/2013.
    Filed Date: 12/27/13.
    Accession Number: 20131227-5130.
    Comments Due: 5 p.m. ET 1/17/14.

    Docket Numbers: ER14-875-000.
    Applicants: Calpine Mid-Atlantic Generation, LLC.
    Description: Calpine Mid-Atlantic Generation, LLC submits Notice of
Succession, Reactive Rate Schedule to be effective 12/27/2013.
    Filed Date: 12/27/13.
    Accession Number: 20131227-5131.
    Comments Due: 5 p.m. ET 1/17/14.

    Docket Numbers: ER14-876-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: PJM Interconnection, L.L.C. submits PJM and MISO
submit revisions to the PJM-MISO JOA re IARR to be effective 2/26/2014.
    Filed Date: 12/27/13.
    Accession Number: 20131227-5151.
    Comments Due: 5 p.m. ET 1/17/14.

    Docket Numbers: ER14-877-000.
    Applicants: ISO New England Inc.
    Description: ISO New England Inc. submits response to Order No. 784
regarding compliance requirements.
    Filed Date: 12/27/13.
    Accession Number: 20131227-5162.
    Comments Due: 5 p.m. ET 1/17/14.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: December 30, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-00011 Filed 1-6-14; 8:45 am]
BILLING CODE 6717-01-P [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/
DATE][NOTICES]


[Federal Register Volume 83, Number 210 (Tuesday, October 30, 2018)]
[Notices]
[Pages 54598-54604]
[FR Doc No: 2018-23710]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0188]

Denial of Hearing Request Regarding Proposal To Refuse To Approve
a New Drug Application for Oxycodone Hydrochloride Immediate-Release
Abuse-Deterrent Formulation, Oral Capsules, 5 Milligrams, 15
Milligrams, and 30 Milligrams; Order Refusing Approval

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Chief Scientist is denying a request for a hearing
regarding the proposal by the Center for Drug Evaluation and Research
(CDER) of the Food and Drug Administration (FDA or Agency) to refuse to
approve a new drug application submitted by Pharmaceutical
Manufacturing Research Services, Inc. (PMRS) for oxycodone
hydrochloride (HCl) immediate-release (IR) capsules, 5 milligrams (mg),
15 mg, and 30 mg in its present form. The Chief Scientist denies
approval.

DATES: The order is applicable October 30, 2018.

FOR FURTHER INFORMATION CONTACT: Nathan R. Sabel, 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. Procedural Background

    PMRS submitted new drug application (NDA) 209155 for oxycodone HCl
IR capsules, 5 mg, 15 mg, and 30 mg, under section 505(b)(2) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(b)(2)),
relying in part on the Agency's previous findings of safety and
effectiveness for ROXICODONE (oxycodone HCl IR tablets (NDA 021011))
(Ref. 1).
    PMRS's product contains excipients, including a dye blend, that
have solubility in common solvents, including water and ethanol,
similar to the solubility of the active pharmaceutical ingredient
(API). PMRS contends that a solution prepared from its product for
subcutaneous or intravenous injection will look relatively ``impure''
compared to a solution prepared from Roxicodone and will have a dark,
opaque, ``contaminated-looking'' appearance, providing both a ``visual
deterrent'' and a ``chemical deterrent'' to abuse by injection (Refs. 2
and 3).\1\ PMRS provided in vitro data intended to show that a solution
prepared for injection would have these qualities but provided no data
or literature supporting the conclusion that people who inject opioids
would, in fact, be deterred from injecting such a solution (Ref. 2).
---------------------------------------------------------------------------

    \1\ With respect to the purported ``chemical deterrent'' aspect
of its product, we note that PMRS's claims that its product resists
physical and chemical ``extraction'' appear to rest on a
misunderstanding of how that term is used in the context of abuse-
deterrent opioids. PMRS appears to be using the term ``extraction''
to mean that it is difficult to separate the API from the excipients
in solution, not that it is difficult to prepare a solution that
contains the API. In fact, PMRS's data show that the oxycodone in
its formulation can be readily extracted in commonly available
solvents into a solution physically suitable for injection. These
data show that more of the API could be extracted from oxycodone HCl
IR capsules (approximately 98 percent of the API) than from
ROXICODONE (approximately 90-91 percent) in both small and medium
volume extraction and at ambient and high temperatures (Refs. 1 and
2).
---------------------------------------------------------------------------

    PMRS also provided in vitro data intended to demonstrate that its
product would be more difficult to grind into particle sizes suitable
for snorting compared to ROXICODONE but provided no data from studies
in human subjects to evaluate the pharmacokinetic or pharmacodynamic
properties of the product following abuse via the nasal route (Ref.
1).\2\ Nonetheless, PMRS proposed labeling for its product representing
that it has abuse-deterrent properties (Ref. 4).
---------------------------------------------------------------------------

    \2\ While PMRS initially intended for the product to confer
resistance to grinding to particle sizes suitable for snorting (Ref.
7), PMRS has conceded, based on the results of its testing, that the
formulation should not be considered to have this property. See Ref.
2 at 12-13 (``Because of the decrease in particle size distribution
after grinding as the drug product ages, resistance to grinding
cannot be considered as one of the characteristics of [PMRS'
product]'').
---------------------------------------------------------------------------

    On November 16, 2017, CDER issued a complete response letter to
PMRS under Sec.  314.110(a) (21 CFR 314.110(a)) stating that the NDA
could not be

approved in its present form, describing the specific deficiencies,
and, where possible, recommending ways PMRS might remedy these
deficiencies (Ref. 5). The deficiencies cited include the following:
    (1) The application in its present form is not approvable with the
proposed labeling describing abuse-deterrent properties, for multiple
reasons. In particular, (a) the oxycodone in the formulation can be
readily extracted in commonly available solvents into a solution
suitable for injection; (b) there were insufficient data showing the
presence of excipients (including dye) in the formulation can be
expected to deter abuse by injection; (c) the data submitted were
insufficient to show the product was meaningfully resistant to
manipulation for misuse or abuse; and (d) there were not data
submitted, including data from pharmacokinetic and human abuse
liability studies, fully characterizing the product's abuse potential
by all relevant routes of abuse. Also, the data submitted were not
sufficient to rule out the possibility that the proposed formulation
could result in a greater proportion of abuse by injection of PMRS's
product compared to a conventional oxycodone IR formulation. Abuse by
injection carries greater risk of overdose and transmission of
infectious disease than abuse by other routes.
    (2) The safety and purity of the excipients intended (but not
shown) to confer abuse-deterrent properties were not adequately
characterized, either by the intended oral route of use or by expected
routes of abuse, including injection.
    (3) An overall evaluation of elemental impurities in the final
formulation and a risk assessment for each heavy metal (taking into
consideration the maximum daily dose) were not provided.
    (4) The application did not fully comply with the patent
certification requirements applicable to applications submitted under
section 505(b)(2) of the FD&C Act.
    The complete response letter describes additional deficiencies
relating to the chemistry, manufacturing, and controls (CMCs) and
current good manufacturing practice requirements that CDER determined
precluded approval of the application in its present form (Ref. 5). The
complete response letter also noted that satisfactory resolution of
objectionable inspection observations was required before the
application could be approved (Ref. 5).
    In response to the complete response letter, on November 17, 2017,
PMRS submitted a request for an opportunity for hearing under Sec.
314.110(b)(3) on whether there are grounds under section 505(d) of the
FD&C Act for denying approval of the NDA.
    On February 13, 2018, FDA published a notice of opportunity for a
hearing (NOOH) setting forth CDER's proposal to refuse to approve
PMRS's NDA for oxycodone HCl IR capsules in 5-mg, 15-mg, and 30-mg
strengths (83 FR 6196). The NOOH stated that, for the reasons described
above and others described in the complete response letter, notice is
given to PMRS and to all other interested persons that FDA proposes to
issue an order refusing to approve the NDA because the application
fails to meet the criteria for approval under section 505(d) of the
FD&C Act, including that: (1) PMRS has not provided sufficient data to
show that the product would be safe (section 505(d)(1)); (2) PMRS has
not shown that the methods used in, and the facilities and controls
used for, the manufacture, processing, or packing of the product are
adequate to preserve its identity, strength, quality, and purity
(section 505(d)(3)); and (3) the labeling PMRS proposed for the product
is false or misleading (section 505(d)(7)).
    PMRS submitted a request for a hearing on February 15, 2018. PMRS
also submitted data, information, and analysis in support of its
hearing request on April 13, 2018 (April Submission).\3\ CDER submitted
a proposed order on June 13, 2018, and PMRS submitted a Response to
CDER's Proposed Order on August 9, 2018 (August Submission), consistent
with regulations at Sec.  314.200(g)(3) (21 CFR 314.200(g)(3)),
affording the hearing requestor 60 days to respond to a proposed order.
---------------------------------------------------------------------------

    \3\ Although timely filed, PMRS did not submit the data,
information, and factual analysis in the required format (e.g., the
submission lacks a statement signed by the person responsible for
such submission that it includes in full all studies and information
as required) (Sec.  314.200(d)(3)). The Chief Scientist has
nevertheless reviewed PMRS's April Submission in its entirety.
---------------------------------------------------------------------------

II. Statutory and Regulatory Framework Regarding 21 CFR Part 12
Hearings

    Under Sec.  12.24(a)(2) (21 CFR 12.24(a)(2)), the Agency reviews a
hearing request to determine whether a hearing has been 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; \4\ (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; \5\ (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); \6\ (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, 12.22, and 314.200, and in the NOOH are met.
Similarly, Sec.  314.200(g) provides that a person requesting a hearing
``may not rely upon allegations or denials but is required to set forth
specific facts showing that there is a genuine and substantial issue of
fact that requires a hearing with respect to a particular drug product
specified in the request for hearing.''
---------------------------------------------------------------------------

    \4\ See also Georgia Pacific Corp. v. U.S. EPA, 671 F.2d 1235,
1241 (9th Cir. 1982) (finding that a party's argument that a hearing
is necessary to ``sharpen the issues'' or to ``fully develop the
facts'' is not sufficient to justify a hearing); Citizens for
Allegan County, Inc. v. FPC, 414 F.2d 1125, 1128 (D.C. Cir. 1969)
(finding that ``no evidentiary hearing is required where there is no
dispute on the facts and the agency proceeding involves only a
question of law.''); and Sun Oil Co. v. FPC, 256 F.2d 233, 240 (5th
Cir. 1958), cert. denied, 358 U.S. 872 (1958).
    \5\ See also John D. Copanos & Sons, Inc. and Kanasco, Ltd. v.
FDA, 854 F.2d 510, 522 (D.C. Cir. 1988) (``The mere existence of
some alleged factual dispute between the parties will not defeat an
otherwise properly supported motion for summary judgment; the
requirement is that there be no genuine issue of material fact . . .
Only disputes over facts that might affect the outcome of the suit
under the governing law will properly preclude the entry of summary
judgment. Factual disputes that are irrelevant or unnecessary will
not be counted.'') (emphasis in original), quoting Anderson v.
Liberty Lobby, Inc., 477 U.S. 242, 247-248 (1986) and Hynson, 412
U.S. at 620.
    \6\ See also Hynson, 412 U.S. at 621 (1973) and Dyestuffs &
Chemicals, Inc. v. Flemming, 271 F.2d 281, 286 (8th Cir. 1959)
(``Where the objections stated and the issues raised thereby are,
even if true, legally insufficient, their effect is a nullity and no
objections have been stated. Congress did not intend the
governmental agencies created by it to perform useless or unfruitful
tasks.''), cert. denied, 362 U.S. 911 (1960).
---------------------------------------------------------------------------

III. Analysis

    Following review of the administrative record related to this
proceeding, the Chief Scientist \7\ finds that PMRS has not raised a
genuine and substantial issue of fact justifying a hearing regarding
CDER's proposal to refuse to approve the NDA in its present form.\8\ As
further explained below, the Chief Scientist finds that a hearing would
not otherwise be in the public interest. Accordingly, the Chief
Scientist denies PMRS's hearing request under Sec. Sec.  12.24(b) and
314.200(g) and orders approval denied under section 505(d) of the FD&C
Act for PMRS's NDA in its present form.
---------------------------------------------------------------------------

    \7\ Under FDA Staff Manual Guide 1410.21, the Chief Scientist is
authorized to perform all delegable functions of the Commissioner of
Food and Drugs. (See FDA Staff Manual Guide 1410.21 ] 1.B.7).
    \8\ PMRS suggests that it has an absolute statutory right to a
hearing on whether its NDA is approvable under section 505(c)(1)(B)
of the FD&C Act without regard to whether it can satisfy the
criteria for a hearing set forth in FDA's regulations, including the
requirement that a person requesting a hearing must demonstrate with
data and analysis that there is a genuine and substantial issue of
fact that requires a hearing (April Submission at 6-7). PMRS is
incorrect. FDA's duly issued summary judgment procedures have been
consistently upheld and are fully compatible with section
505(c)(1)(B) of the FD&C Act. ``It is well established that the
statutory grant of a public hearing is not absolute'' (Community
Nutrition Inst. v. Young, 773 F.2d 1356, 1364 (D.C. Cir. 1985)). FDA
has the authority to deny a hearing when it appears from the
submission of the party requesting a hearing that no substantial
issue of fact is in dispute (Pineapple Growers Ass'n, 673 F.2d at
1085-86; Hynson, 412 U.S. at 621; Hess & Clark, Inc. v. FDA, 495
F.2d 975, 983 (D.C. Cir. 1974)).
---------------------------------------------------------------------------

A. PMRS's Request for a Hearing Is Denied Because No Genuine and
Substantial Issue of Fact Exists Regarding the Lack of Sufficient,
Reliable Evidence Supporting PMRS's Proposed Labeling for Abuse-
Deterrent Properties

    Among other bases for proposing to deny PMRS's NDA, the NOOH cites
the requirement that FDA deny approval to applications that propose
labeling that is false or misleading in any particular (see section
505(d)(7) of the FD&C Act; 21 CFR 314.125(b)(6)). On this basis, the
November 16, 2017, complete response letter explained that the NDA in
its current form is not approvable with the proposed labeling
describing abuse-deterrent properties. PMRS proposed labeling that
includes multiple statements that the product has properties that make
it more difficult to manipulate for purposes of abuse and misuse than a
conventional formulation (Ref. 6). These statements include the
assertion that the product ``is formulated with inactive ingredients
that make the capsule more difficult to manipulate for misuse and
abuse'' and that ``the results of this testing demonstrated that [the
product] capsules, in comparison to Roxicodone tablets, have increased
resistance to physical and chemical extraction.'' (Ref. 6).\9\
---------------------------------------------------------------------------

    \9\ In its latest submission, PMRS appears to propose revising
its NDA labeling to include the statement ``Oxycodone HCl IR ADF
capsules should be prescribed knowing meaningful abuse-deterrent
properties have not been proven,'' among other labeling adjustments
(August Submission at 5). First, PMRS cannot adjust the content of
the NDA that is the subject of this hearing process in the middle of
the process itself. Among other reasons, the question this
proceeding seeks to resolve is not whether PMRS might formulate an
NDA that might address some of the deficiencies cited in the NOOH.
Rather, this process seeks to determine whether the application PMRS
submitted to CDER for review should be denied approval as CDER
proposes. PMRS may not change the substance of that application
during this proceeding. Second, given that the ``ADF'' abbreviation
of the product name PMRS retains in this revised language stands for
``Abuse Deterrent Formulation,'' it is difficult to see how this
change, even if permissible, would remove the concern that is the
primary focus of this order: that PMRS's labeling represents that
its product possesses abuse-deterrent properties when the presence
of such properties is not supported by substantial and reliable
evidence. Consistent with the regulations governing this 21 CFR part
12 proceeding, this order evaluates PMRS's NDA as it was evaluated
by CDER and not as PMRS might seek to modify that application now.
If PMRS wishes to seek Agency review of a different NDA at this
juncture, the appropriate avenue would be to submit a new
application through the standard Agency process.
---------------------------------------------------------------------------

    Specifically, the complete response letter explained that PMRS
submitted ``[n]o data . . . to support the proposed hypothesis that the
presence of excipients or dye in the solution would create a deterrence
to intravenous abuse'' (Ref. 5). Generally, PMRS's hypothesis is that
commonly used methods of preparing a solution for injection, if applied
to its product, will result in a solution that will look ``visually
unappealing'' compared to a solution prepared from Roxicodone, and will
have a dark, opaque, ``contaminated-looking'' appearance that will
serve as a ``visual deterrent'' to abuse (Ref. 2). PMRS's NDA provided
in vitro data intended to show that a solution prepared for injection
would have such an appearance (Refs. 2 and 3).\10\
---------------------------------------------------------------------------

    \10\ According to CDER's review, there remain some questions
concerning whether a solution extracted from PMRS's formulation
would consistently have the dark or opaque appearance observed in
PMRS's in vitro data. The appearance of an extracted solution of the
product may vary, depending on the solvent used in extraction and
filtering methods employed by experienced abusers. However, for the
purposes of this order, the Chief Scientist assumes that the
solution extracted from PMRS's formulation appears as a dark, opaque
solution.
---------------------------------------------------------------------------

    As CDER informed PMRS during the application process, CDER
considered this in vitro data unable to prove that PMRS's hypothesis is
correct that individuals would actually be deterred by the appearance
of a solution prepared from this formulation (Ref. 8). Although a
solution prepared from PMRS's product may appear a certain way based on
the in vitro data provided, PMRS has produced no scientific data or
information to establish that people who inject opioids would be less
likely to do so because of this appearance or based upon knowledge that
the solution contains other components of the drug product in addition
to the API. To demonstrate that this formulation deters abuse, and thus
to support the proposed labeling for abuse-deterrent properties, CDER
asked PMRS to provide evidence sufficient to prove that people who
abuse opioids by injection would be deterred from doing so based on the
solution's appearance.\11\
---------------------------------------------------------------------------

    \11\ CDER informed PMRS of the need for such evidence prior to
PMRS's submission of the NDA:
    ``At this time, we are not aware of data that support a
deterrent effect based on the presence of a dye in a formulation
intended to be abuse-deterrent. Provide evidence that supports the
concept that the incorporation of a dye into a formulation imparts
abuse-deterrent effects to that formulation. A hypothetical argument
that the presence of a dye will provide an abuse-deterrent effect is
not sufficient to support labeling.'' (Ref. 8).
---------------------------------------------------------------------------

    Critically, however, PMRS's NDA and subsequent submissions in this
proceeding contain no such data or information on this critical
question, either from PMRS's studies of its own product or from any
potentially relevant scientific literature. In lieu of scientifically
valid evidence for the proposition that appearance deters abuse, PMRS
simply reiterates how the solution appears. PMRS states, variously,
that the ``dark, significant color is visually unappealing for
potential intravenous abuse'' (Ref. 2); that ``PMRS considers this
visual deterrent effective in classifying drug products as abuse
deterrent'' (id.); that ``[t]he use of an FD&C dye was considered a
deterrent to abuse as it

provides a visual deterrent once introduced to aqueous solution''
(id.); that ``the ready solubility of the excipients matching the
solubility profile of the API . . . maximiz[es] deterrence by rendering
[the product] less attractive or rewarding for injection due to the
inability to isolate the API from the inactive ingredients for
injection'' (Ref. 9); and that ``it was very important that excipients
for this formulation have same [solubility] in order to provide a
chemical deterrent for abuse'' (Ref. 2).\12\ Despite these assertions
and the in vitro data related to how the product looks in solution,
PMRS has offered no evidence to establish that opioid-abusers will be
deterred by the color or appearance of a solution prepared from PMRS's
formulation.
---------------------------------------------------------------------------

    \12\ We note that PMRS provided some data and information
regarding its particular choice of dye blend, arguing that the blend
it selected was ``the most visually deterring'' of the colors
evaluated ``as it resulted in a dark, opaque, `contaminated-looking'
solution'' (Ref. 2 at page 4). As this order discusses, this data
does not constitute sufficient evidence for the proposition that
people who inject opioids can reasonably be expected to be
``visually deterred'' from doing so based on the appearance of the
solution prepared for injection.
---------------------------------------------------------------------------

    PMRS has also failed to offer evidence to establish its proposed
conclusion related to another deficiency cited in the complete response
letter (Ref. 5), specifically, PMRS's failure to establish that its
product formulation deters abuse by snorting. Despite CDER's requests
that human testing be conducted to establish whether this formulation
deters abuse by snorting (see Refs. 5 and 8), PMRS declined to conduct
such testing or to provide any other information to show that its
product functions to deter abuse by snorting. Without human testing, or
other appropriate data and information, it is not possible to evaluate
whether PMRS's formulation has properties that render it more or less
likely to be snorted.\13\ If the product were in fact less likely to be
snorted, the product could result in shifting the pathway of abuse from
snorting to injection. This shift would increase the product's overall
risks associated with abuse compared to a conventional formulation,
both because abuse by injection of any opioid carries additional risks
particular to that route of abuse (Ref. 10) and because abuse by
injection of PMRS's product in particular carries unknown additional
risks associated with injection of the co-extracted excipients.\14\
---------------------------------------------------------------------------

    \13\ As previously noted, PMRS intended for its formulation to
confer resistance to grinding (for the purpose of snorting) but
ultimately conceded that the product has not been shown to have this
property. See supra footnote 2.
    \14\ In June 2017 FDA sought withdrawal from the market of OPANA
ER (oxymorphone HCl ER tablets (NDA 21610)) based on similar
concerns (Ref. 12). Specifically, FDA requested that OPANA ER be
withdrawn from the market after review of postmarket data showed a
significant shift in the route of abuse from nasal to injection
following the product's reformulation. The reformulated product had
been intended to deter abuse by injection and snorting. Injection
abuse of reformulated OPANA ER has been associated with serious
adverse events, including numerous cases of thrombotic
microangiopathy which are thought to have been related to injection
of the excipients included to deter abuse (Refs. 12 and 13).
---------------------------------------------------------------------------

    The Chief Scientist concludes that PMRS has not created a genuine
and substantial issue of fact justifying a hearing on this issue. As
CDER informed PMRS during the review process and in the complete
response letter, PMRS has not provided evidence that demonstrate its
product deters abuse. Despite requesting a factual hearing and offering
in vitro data intended to demonstrate how its product looks in
solution, PMRS has not provided sufficient and reliable data or
information that creates a genuine and substantial dispute of fact with
respect to whether the appearance of such a solution deters abuse in
the manner PMRS proposes to describe in its labeling. PMRS may have
submitted evidence to show what the product looks like when prepared
for injection but PMRS has not provided no clinical evidence--or indeed
any evidence--that this appearance will deter abuse as PMRS's NDA
represents in its proposed labeling. In addition, PMRS has failed to
provide sufficient evidence to establish that the product formulation
deters abuse by snorting. As a result, there exists no contested
factual issue with respect to the information available to demonstrate
whether PMRS's formulation possesses abuse-deterrent properties.
Accordingly, the Chief Scientist denies PMRS's request for a factual
hearing on this issue under Sec. Sec.  12.24(b) and 314.200(g) because
there exists no genuine and substantial issue of fact that would
require such a hearing to resolve.

B. PMRS's NDA Proposes Labeling That Is False and Misleading Under
Section 505(d)(7) of the FD&C Act and Is Therefore Appropriately Denied
Approval

    Having found that that is no genuine and substantial question of
fact with respect to whether PMRS's proposed labeling is false or
misleading, the Chief Scientist also finds that the Agency must
therefore issue an order refusing to approve PMRS's NDA in its present
form under section 505(d)(7) of the FD&C Act.
    FDA makes approval decisions, including decisions regarding the
content of FDA-approved prescription drug labeling, based on a
comprehensive scientific evaluation of the available data and
information, allowing only information for which there is a scientific
basis to be included.\15\ As discussed above, no evidence establishes
the proposition that this formulation has the abuse-deterrent
properties PMRS proposes to include in its product labeling.\16\ The
absence of such evidence in support of PMRS's assertions is
particularly problematic in light of the novel and highly speculative
nature of PMRS's abuse-deterrence hypothesis. It is well understood
that people suffering from opioid use disorder--particularly people who
abuse opioids by injection--routinely take extraordinary risks in
connection with their opioid abuse. The individuals who abuse opioids
by injection are known to be undeterred by such serious risks as
disease transmission (including HIV and hepatitis C) associated with
needle-sharing, injection-site infections, overdose, and even death
(Ref. 10). Certain ``street'' opioids, such as black tar heroin, are
commonly administered by injection despite their contaminated
appearance (Ref. 11) and despite the real risks associated with the
unknown composition and purity of such products (including, but not
limited to, the presence of contaminants).
---------------------------------------------------------------------------

    \15\ See, e.g., 21 CFR 201.56(a)(1) (providing that the labeling
of prescription drugs must contain a summary of the essential
scientific information needed for the safe and effective use of the
drug), 21 CFR 201.56(a)(2) (providing that the labeling must be
informative and accurate and neither promotional in tone nor false
or misleading in any particular and that labeling must be updated
when new information becomes available that causes the labeling to
become inaccurate, false, or misleading), and 21 CFR 201.56(a)(3)
(providing that labeling must be based whenever possible on data
derived from human experience).
    \16\ As noted previously, PMRS's claims that its product resists
physical and chemical ``extraction'' appear to rest on a
misunderstanding of how that term is used in the context of abuse-
deterrent opioids. See supra footnote 1.
---------------------------------------------------------------------------

    Against this backdrop, PMRS's unsupported assertions and in vitro
data are insufficient to demonstrate that its product formulation will
deter abuse. Given the lack of data establishing the effect of PMRS's
formulation on its risks of abuse compared to a conventional
formulation, the labeling statements PMRS has proposed suggesting that
sufficient and reliable evidence exists and establishes that PMRS's
formulation deters abuse would be false and misleading. Thus, the
proposed labeling

includes false and misleading statements suggesting that PMRS's product
is expected to be safer than a conventional formulation with respect to
the risks of abuse when this conclusion remains unproven.\17\
Accordingly, the Chief Scientist has determined that PMRS has not
submitted data or information that can support a conclusion that its
product would deter abuse by injection and that PMRS's proposed
labeling is false and misleading under section 505(d)(7) in the absence
of such evidence. As a result, the Chief Scientist accepts CDER's
proposal to refuse approval for PMRS's NDA in its present form.
---------------------------------------------------------------------------

    \17\ During the review process, PMRS proposed that its labeling
include the following disclaimers: ``Abuse of TRADENAME by
injection, as well as by the oral and nasal routes, is still
possible,'' and ``there is no clinical evidence that TRADENAME has a
reduced abuse liability compared to immediate-release oxycodone''
(Ref. 6). These disclaimers do not render PMRS's other abuse-
deterrent labeling statements any less false and misleading. For
example, the first disclaimer implies that the product has abuse-
deterrent properties, while stating that these properties do not
render the product abuse-proof. The second disclaimer conveys an
assessment of the product's abuse-deterrent properties is not based
on data from human studies but continues to suggest that the product
possesses these (unproven) properties. In the context of the other
labeling PMRS proposes related to abuse-deterrence, these
disclaimers, if anything, render the NDA's proposed labeling even
more misleading.
---------------------------------------------------------------------------

C. PMRS's Legal and Policy Arguments Are Unavailing

    Instead of providing data and information addressing the absence of
genuine and substantial issues of fact discussed in the previous
sections, the PMRS's submissions consists largely of legal and policy
objections to FDA's approach to evaluating, labeling, and approving
opioids, as well as requests for the Agency to take specific actions
regarding other drug products premised on PMRS's proposed alternative
policies regarding opioids. These legal and policy arguments do not
raise a genuine and substantial issue of fact justifying a hearing. See
Sec.  12.24(b)(1) (``A hearing will not be granted on issues of policy
or law.'').\18\ Furthermore, a hearing will not be granted on the issue
of whether FDA should take regulatory actions regarding other drug
products which are not the subject of the NOOH.\19\ Accordingly, this
order does not address the merits of FDA's policies regarding abuse-
deterrent opioids or PMRS's objections to those policies, except as
they apply to the question of whether PMRS has raised a genuine and
substantial issue of fact which precludes CDER's proposal to refuse to
approve PMRS's NDA.\20\ Instead, the Chief Scientist's order addresses
only those aspects of the PMRS submissions that are at least
potentially relevant to the question of whether PMRS has submitted
data, information, or analysis that raises a genuine and substantial
issue of fact justifying a hearing on the issue of whether PMRS's
proposed abuse-deterrent labeling claims are false or misleading.
---------------------------------------------------------------------------

    \18\ Courts have uniformly recognized that an administrative
hearing need not be held to resolve questions of law or policy (see
Citizens for Allegan County, 414 F.2d 1125 (D.C. Cir. 1969); Sun Oil
Co. v. FPC, 256 F.2d 233, 240 (5th Cir.), cert denied, 358 U.S. 872
(1958)).
    \19\ Sec.  314.200(g)(8) (``A request for a hearing, and any
subsequent grant or denial of a hearing, applies only to the drug
products named in [the NOOH]'').
    \20\ Similarly, this order does not address PMRS's arguments
that do not go to the specific deficiencies cited in the complete
response letter and the NOOH, such as its argument that its product,
as well as other opioid products, should not bear labeling
consistent with chronic use and instead should only be labeled for
management of acute pain.
---------------------------------------------------------------------------

    PMRS argues that CDER incorrectly proposed refusing to approve its
NDA with the proposed abuse-deterrent labeling because CDER applied
what PMRS considers the flawed approach to the evaluation and labeling
of abuse-deterrent products contained in FDA's 2015 guidance for
industry, ``Abuse-Deterrent Opioids--Evaluation and Labeling'' (Ref.
14) (the Guidance). Specifically, PMRS argues that the guidance's
emphasis on premarket studies (i.e., laboratory studies and human
testing) is scientifically invalid and that FDA should only approve
abuse-deterrent formulations with abuse-deterrent labeling claims based
on post-market epidemiological data. PMRS contends that data from
premarket studies of abuse deterrence cannot constitute ``substantial
evidence'' that a product deters abuse and therefore results in abuse-
deterrent labeling claims that are false and misleading (April
Submission at 2-5). PMRS further argues that CDER improperly treated
compliance with the guidance approach as a requirement for approval of
abuse-deterrent labeling, rather than merely as a set of
recommendations, in violation of the Administrative Procedure Act (APA)
(April Submission at 5-7). The Chief Scientist finds these arguments
unconvincing and not relevant to the matter at hand.
    First, PMRS makes a policy argument that FDA, by following the
approach described in the Guidance, routinely approves abuse-deterrent
labeling claims that are too strong or overly broad based on premarket
data. But this argument does not raise an issue of fact regarding the
approvability of an NDA for a product bearing a labeling claim that
PMRS characterizes as a ``more appropriately limited claim about abuse
deterrence'' (April Submission at 2). As stated above, PMRS has not
presented data, information, or analysis that support a conclusion that
its product is approvable with its own proposed labeling, rendering the
question of whether ``broader labeling statements'' (April Submission
at 2) should be withheld until supported by post-market epidemiological
data irrelevant for purposes of this order.\21\ Even in its August
submission, PMRS continues to suggest that its product should be
labeled as possessing abuse-deterrent properties, even naming its
product ``ADF'' or Abuse Deterrent Formulation, while simultaneously
arguing that no evidence can demonstrate such properties pre-market
(August Submission at 5).\22\ If PMRS is correct that such properties
cannot be established pre-market, then labeling its product with abuse-
deterrent properties becomes even more transparently false and
misleading. PMRS cannot have it both ways without admitting that their
proposed labeling lacks a scientific basis. Further, even if FDA were
to agree with PMRS that only labeling claims of the type proposed by
PMRS should be approved based on premarket studies, this policy change
would not alter the conclusion that PMRS has not raised a genuine and
substantial issue of fact justifying a hearing regarding CDER's
proposal to refuse to approve PMRS's NDA with the labeling described in
the NDA.\23\
---------------------------------------------------------------------------

    \21\ For similar reasons, the Chief Scientist does not address
the merits of PMRS's legal argument that application of the approach
described in the Guidance raises concerns under the First Amendment.
PMRS contends that ``[i]t cannot be that an Agency can compel an
applicant to forego a more limited truthful and non-misleading claim
and to instead seek broader labeling claims that an applicant finds
objectionable'' (April Submission at 4, footnote 4). Given that PMRS
has not presented data, information, or analysis that support a
conclusion that its product is approvable with what PMRS
characterizes as more limited claims regarding abuse-deterrence,
PMRS's First Amendment objections to broader labeling claims are not
relevant to this proceeding.
    \22\ See supra footnotes 6 and 16.
    \23\ We note that the Guidance was developed after considerable
deliberation by the Agency and after thorough consideration of
stakeholder comments expressed at public meetings and submitted to
the docket. If PMRS wants to provide further input on the Guidance,
there is already a mechanism in place for PMRS to do so (see Sec.
10.115(f)). A hearing on CDER's proposal to refuse to approve PMRS's
NDA, however, is not the proper forum for effecting changes to FDA
policy. See Sec.  12.24(b)(1).
---------------------------------------------------------------------------

    The Chief Scientist finds PMRS's APA claim similarly irrelevant to
the question of whether a hearing should be granted. PMRS contends
that, by recommending that PMRS follow the

approach to evaluating abuse-deterrent opioids described in the
Guidance, and by referring to the guidance in the complete response
letter and other documents, CDER ``effectively converted a nonbinding
guidance document into a requirement for abuse-deterrent labeling that
has the force and effect of the law'' (April Submission at 7). But
challenging FDA's recommended approach for study design to measure
abuse-deterrent effectiveness pre-market is immaterial to the proposal
to refuse PMRS's specific NDA because PMRS has provided no evidence--
either of the type FDA recommended or otherwise--that this formulation
deters abuse. As a result and as discussed in the previous section,
PMRS's proposed labeling remains false and misleading because it
represents abuse-deterrent properties for a formulation that has not
been shown to actually possess those properties.
    In sum, the Chief Scientist concludes that PMRS has raised no legal
or policy argument that alters the determinations discussed in the
previous sections.

D. A Hearing is not Otherwise in the Public Interest

    In its August Submission, PMRS argues that a Part 12 hearing would
be ``otherwise in the public interest'' within the meaning of Sec.
314.200(g)(6) in order to resolve broader policy issues related to
opioid abuse. The Chief Scientist disagrees and finds in her discretion
that a Part 12 hearing on this NDA would not otherwise be in the public
interest.
    As discussed above, PMRS's submissions raise arguments relevant to
FDA's regulation of opioid products and to the crisis of opioid abuse,
generally. For example, PMRS argues that the ``emphasis on so-called
abuse-deterrent formulations and labeling in response to the opioid
epidemic has resulted in the market entry of additional misbranded
products'' and that ``[s]uch false and misleading labeling serves only
to confuse prescribers and patients about what the product is and . . .
is not'' (April Submission at 4). In its submissions, PMRS also
requests that FDA take specific regulatory action regarding several
other specific opioid products.
    The Agency continues to take a variety of steps to address the
public health crisis created by opioid abuse and the resulting
addiction and death. For example, in May 2017, the Commissioner of Food
and Drugs (the Commissioner) announced the establishment of an Opioid
Policy Steering Committee to explore and develop additional approaches
or strategies FDA could deploy to combat the opioid crisis.\24\ FDA has
also held public hearings on topics relating to opioid abuse, including
to receive stakeholder input on how FDA might, under its Risk
Evaluation and Mitigation Strategy (REMS) authority, improve the safe
use of opioid analgesics by curbing overprescribing to decrease the
occurrence of new addictions and limit misuse and abuse of opioid
analgesics.\25\
---------------------------------------------------------------------------

    \24\ See 82 FR 58572 (December 13, 2017).
    \25\ Id.
---------------------------------------------------------------------------

    The Agency is also working to enhance prescriber and patient
awareness of the safe use of opioids. In 2017, FDA notified holders of
approved applications for IR opioid analgesics of the Agency's
determination that a REMS is necessary for IR opioid analgesics to
ensure that the benefits of these drugs continue to outweigh the risks.
Under this new policy, the IR opioid analgesics that are intended to be
used in the outpatient setting will be subject to the same REMS
requirements as the Extended-Release/Long-Acting opioid analgesics.
    In addition, the Agency is undertaking a study to improve its
understanding of prescriber beliefs relating to use of opioid products
with abuse-deterrent properties.\26\ The Agency is evaluating
currently-used nomenclature for such products, including by surveying
doctors to better understand how they perceive these terms and to
assess the clinical understanding that has developed around products
with labeling for abuse-deterrent properties. Further, FDA is
continuously monitoring the safety of approved opioid products based on
post-market information, including through a focus on improving post-
market data collection in this area.
---------------------------------------------------------------------------

    \26\ See Scott Gottlieb, M.D., Commissioner of Food and Drugs,
Remarks Delivered Before FDA's Scientific Meeting on Opioids (July
10, 2017), available at https://www.fda.gov/newsevents/speeches/ucm566189.htm.
---------------------------------------------------------------------------

    As these examples show, the Agency is working to address the crisis
of opioid addiction and abuse and recognizes the importance of seeking
public comment and participation relevant to FDA's opioid-related
policies. However, the Chief Scientist does not believe that a Part 12
hearing on the approvability of PMRS's NDA is an appropriate forum to
address such concerns and finds in her discretion that such a hearing
would not be in the public interest.

E. Additional Issues Not Decided by This Order

    As described above, the Chief Scientist has determined that PMRS
has not raised a genuine and substantial issue of fact that would
warrant a hearing and that PMRS's proposed labeling containing abuse-
deterrent representations would be false and misleading under section
505(d)(7) of the FD&C Act. Although the complete response letter and
NOOH describe additional deficiencies in PMRS's NDA, it is not
necessary to address these issues in this order because, even if
resolved in PMRS's favor, PMRS's NDA would still be refused approval in
its present form under section 505(d)(7) of the FD&C Act.\27\
---------------------------------------------------------------------------

    \27\ ``A hearing will be denied if the Commissioner concludes
that the data and information submitted are insufficient to justify
the factual determination urged even if accurate.'' Sec.
12.24(b)(3). Furthermore, ``[a] hearing will not be granted on
factual issues that are not determinative with respect to the action
requested, e.g., if the Commissioner concludes that the action would
be the same even if the factual issue were resolved in the way
sought[.]'' Sec.  12.24(b)(4).
---------------------------------------------------------------------------

IV. Findings and Order

    For the reasons described above, the Chief Scientist finds that
PMRS has not raised any genuine and substantial issue of fact that
would justify a hearing (see Sec. Sec.  12.24(b)(1) and 314.200(g)(1)).
Accordingly, PMRS's request for a hearing is denied. The record
conclusively shows that the approval criteria set forth in section
505(d)(7) of the FD&C Act have not been met. Therefore, under section
505(d) of the FD&C Act of the FD&C Act, the Chief Scientist hereby
denies approval to PMRS's NDA in its present form.

V. References

    The following references marked with an asterisk (*) are on display
in the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and
are available for reviewing by interested persons between 9 a.m. and 4
p.m., Monday through Friday; they are also available electronically at
https://www.regulations.gov. The reference without an asterisk is not
on public display at https://www.regulations.gov because it has
copyright restriction. References without asterisks are available for
viewing only at the Dockets Management Staff. FDA has verified the
website addresses, as of the date this document publishes in the
Federal Register, but websites are subject to change over time.

* 1. Clinical Review, Cross-Discipline Deputy Director Review and
Summary Division Director Review, NDA 209155.
* 2. ``Module 3 Quality, 3.2.P.2.2 Drug Product,'' PMRS Inc., NDA
209155.
* 3. ``Module 2 Common Technical Document Summaries,'' PMRS, NDA
209155.

* 4. Proposed labeling for oxycodone HCl IR capsules, PMRS, NDA
209155 (Dec. 2017).
* 5. Complete Response letter, NDA 209155 (November 16, 2017).
* 6. ``Filing Communication Responses,'' PMRS, NDA 209155.
* 7. ``Request for Priority Review Designation,'' PMRS, NDA 209155.
* 8. ``Memorandum of Meeting Minutes'' for Type B, Pre-NDA, July 11,
2016 teleconference (August, 8, 2016).
* 9. ``NDA 209155 CMC Information Request 5-25-17,'' PMRS, NDA
209155.
* 10. Centers for Disease Control, ``Integrated Prevention Services
for HIV Infection, Viral Hepatitis, Sexually Transmitted Diseases,
and Tuberculosis for Persons Who Use Drugs Illicitly: Summary
Guidance From the CDC and the U.S. Department of Health and Human
Services,'' Morbidity and Mortality Weekly Report, vol. 61, pp. 1-
40, 2012.
* 11. National Institute on Drug Abuse, ``What is heroin and how is
it used?'', available at https://www.drugabuse.gov/publications/research-reports/heroin/what-heroin (accessed June 13, 2018).
* 12. FDA News Release, ``FDA requests removal of Opana ER for risks
related to abuse'' (June 8, 2017), available at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm562401.htm.
13. Hunt, R. et al., ``A Mechanistic Investigation of Thrombotic
Microangiopathy Associated with IV Abuse of Opana ER,'' Blood, Feb.
16, 2017.
* 14. FDA Guidance for Industry ``Abuse-Deterrent Opioids--
Evaluation and Labeling,'' available at https://www.fda.gov/downloads/Drugs/Guidances/UCM334743.pdf.

    Dated: October 25, 2018.
Denise Hinton,
Chief Scientist.
[FR Doc. 2018-23710 Filed 10-29-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 238 (Tuesday, December 13, 2022)]
[Notices]
[Pages 76197-76198]
[FR Doc No: 2022-27014]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA 2022-N-3091]

Advisory Committee; Cardiovascular and Renal Drugs Advisory
Committee; Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of Federal advisory committee.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Cardiovascular and Renal Drugs Advisory Committee by the
Commissioner of Food and Drugs (the Commissioner). The Commissioner has
determined that it is in the public interest to renew the
Cardiovascular and Renal Drugs Advisory Committee for an additional 2
years beyond the charter expiration date. The new charter will be in
effect until the August 27, 2024, expiration date.

DATES: Authority for the Cardiovascular and Renal Drugs Advisory
Committee will expire on August 27, 2024 unless the Commissioner
formally determines that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Joyce Yu, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services and by the General Services
Administration, FDA is announcing the renewal of the Cardiovascular and
Renal Drugs Advisory Committee (the Committee). The Committee is a
discretionary Federal advisory committee established to provide advice
to the Commissioner. The Committee advises the Commissioner or designee
in discharging responsibilities as they relate to helping to ensure
safe and effective drugs for human use and, as required, any other
product for which FDA has regulatory responsibility.
    The Committee reviews and evaluates available data concerning the
safety and effectiveness of marketed and investigational human drug
products for use in the treatment of cardiovascular and renal disorders
and makes appropriate recommendations to the Commissioner.
    The Committee shall consist of a core of 11 voting members
including the Chair. Members and the Chair are selected by the
Commissioner or designee from among authorities knowledgeable in the
fields of cardiology, hypertension, arrhythmia, angina, congestive
heart failure, diuresis, and biostatistics. Members will be invited to
serve for overlapping terms of up to 4 years. Non-Federal members of
this committee will serve as Special Government Employees,
representatives, or Ex-Officio members. Federal members will serve as
Regular Government Employees or Ex-Officios. The core of voting members
may

include one technically qualified member, selected by the Commissioner
or designee, who is identified with consumer interests and is
recommended by either a consortium of consumer-oriented organizations
or other interested persons. In addition to the voting members, the
Committee may include one non-voting representative member who is
identified with industry interests. There may also be an alternate
industry representative.
    Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/advisory-committees/cardiovascular-and-renal-drugs-advisory-committee/cardiovascular-and-renal-drugs-advisory-committee-charter or by contacting the Designated
Federal Officer (see FOR FURTHER INFORMATION CONTACT). In light of the
fact that no change has been made to the committee name or description
of duties, no amendment will be made to 21 CFR 14.100.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: December 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27014 Filed 12-12-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: July 28, 2008 (Volume 73, Number 145)]
[Proposed Rules]
[Page 43643-43646]
[DOCID:fr28jy08-11]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0735; Directorate Identifier 2008-NM-085-AD]
RIN 2120-AA64

Airworthiness Directives; McDonnell Douglas Model DC-10-10, DC-
10-10F, DC-10-15, DC-10-30, DC-10-30F (KC-10A and KDC-10), DC-10-40,
DC-10-40F, MD-10-10F, MD-10-30F, MD-11, and MD-11F Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to supersede an existing airworthiness
directive (AD) that applies to certain McDonnell Douglas transport
category airplanes. The existing AD currently requires modification of
the installation wiring for the electric motor-operated auxiliary
hydraulic pumps in the right wheel well area of the main landing gear;
repetitive inspections of the numbers 1 and 2 electric motors of the
auxiliary hydraulic pumps for electrical

resistance, continuity, mechanical rotation, and associated airplane
wiring resistance/voltage; and corrective actions if necessary. This
proposed AD would, for certain airplanes, also require modifying and
rerouting, as applicable, certain components of the wiring of the
electric motor for the auxiliary hydraulic pump located in the right
wheel well. This proposed AD results from reports of failure of the
electric motor for the auxiliary hydraulic pump. We are proposing this
AD to prevent failure of the electric motors of the hydraulic pump and
associated wiring, which could result in fire at the auxiliary
hydraulic pump and consequent damage to the adjacent electrical
equipment and/or structure.

DATES: We must receive comments on this proposed AD by September 11,
2008.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
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: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Boeing
Commercial Airplanes, Long Beach Division, 3855 Lakewood Boulevard,
Long Beach, California 90846, Attention: Data and Service Management,
Dept. C1-L5A (D800-0024).

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Ken Sujishi, Aerospace Engineer, Cabin
Safety/Mechanical and Environmental Systems Branch, ANM-150L, FAA, Los
Angeles Aircraft Certification Office, 3960 Paramount Boulevard,
Lakewood, California 90712-4137; telephone<PHONE_NUMBER>; fax (562)
627-5210.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2008-0735;
Directorate Identifier 2008-NM-085-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    On February 26, 2004, we issued AD 2004-05-20, amendment 39-13515
(69 FR 11504, March 11, 2004), for certain McDonnell Douglas Model DC-
10-10, DC-10-10F, DC-10-15, DC-10-30, DC-10-30F (KC-10A and KDC-10),
DC-10-40, DC-10-40F, MD-10-10F, MD-10-30F, MD-11, and MD-11F airplanes.
That AD requires modification of the installation wiring for the
electric motor-operated auxiliary hydraulic pumps in the right wheel
well area of the main landing gear, and repetitive inspections of the
numbers 1 and 2 electric motors of the auxiliary hydraulic pumps for
electrical resistance, continuity, mechanical rotation, and associated
airplane wiring resistance/voltage; and corrective actions if
necessary. That AD resulted from several reports of failure of the
auxiliary hydraulic pump systems on Model DC-10 airplanes. We issued
that AD to prevent failure of the electric motors of the hydraulic pump
and associated wiring, which could result in fire at the auxiliary
hydraulic pump and consequent damage to the adjacent electrical
equipment and/or structure.

Actions Since Existing AD Was Issued

    Since we issued AD 2004-05-20, we have determined that the actions
specified in Boeing Alert Service Bulletin DC10-29A144, Revision 2,
dated August 1, 2003, do not completely resolve the unsafe condition
for Model DC-10-10, DC-10-10F, DC-10-15, DC-10-30, DC-10-30F (KC-10A
and KDC-10), DC-10-40, and DC-10-40F airplanes. (We referred to that
service bulletin in AD 2004-05-20 as the appropriate source of service
information for modifying the installation wiring of the electric
motor-operated auxiliary hydraulic pumps in the right wheel well area
of the main landing gear for the airplanes listed above and for Model
MD-10-10F and MD-10-30F airplanes.) Boeing has now issued new service
information, described below, that includes revised procedures to
resolve the unsafe condition for Model DC-10-10, DC-10-10F, DC-10-15,
DC-10-30, DC-10-30F (KC-10A and KDC-10), DC-10-40, and DC-10-40F
airplanes.

Relevant Service Information

    We have reviewed Boeing Alert Service Bulletin DC10-29A148, dated
March 20, 2008, for certain McDonnell Douglas Model DC-10-10, DC-10-
10F, DC-10-15, DC-10-30, DC-10-30F (KC-10A and KDC-10), DC-10-40, and
DC-10-40F airplanes. The service bulletin describes procedures for
modifying and rerouting, as applicable, certain components of the
wiring of the electric motor for the auxiliary hydraulic pump located
in the right main landing gear wheel well.
    The rerouting involves relocating bracket assemblies to meet
certain specified dimensions, or rerouting the brake pressure sensor
wire assembly, as applicable.
    The modification includes various installations, and investigative
(inspections, checks) and corrective actions, as applicable. The
installations and the investigative and corrective actions are
described below:
     Installing a new support assembly, new nut clips, and new
bracket assemblies.
     Inspecting the wire insulation for cracks, splits or
tears, and for evidence of wire chafing.
     Replacing wires if necessary.
     Installing protective sleeving.
     Checking the resistance of the electric motor ground
wires, and corrective action if the resistance is not within the
specified measurement. The corrective action for incorrect resistance
involves checking the electrical bond surface; inspecting wires for
cracks, damage, corrosion, or cross connection; checking sockets and
lugs for proper crimp and ground studs for proper torque; and replacing
the wire, socket, lug, and ground stud if necessary.
    We have also reviewed Boeing Alert Service Bulletin DC10-29A142,
Revision 3, dated October 15, 2005, for McDonnell Douglas Model DC-10-
10, DC-10-10F, DC-10-15, DC-10-30, DC-

10-30F (KC-10A and KDC-10), DC-10-40, DC-10-40F, MD-10-10F, and MD-10-
30F airplanes. We referred to Boeing Alert Service Bulletin DC10-
29A142, Revision 02, dated April 17, 2003, in AD 2004-05-20 as the
appropriate source of service information for doing prior/concurrent
actions. The procedures in Revision 3 are essentially the same as those
in Revision 02, with editorial changes that do not affect how the
actions are done.
    Accomplishing the actions specified in the service information is
intended to adequately address the unsafe condition.

FAA's Determination and Requirements of the Proposed AD

    We have evaluated all pertinent information and identified an
unsafe condition that is likely to develop on other airplanes of the
same type design. For this reason, we are proposing this AD, which
would supersede AD 2004-05-20, and would retain the requirements of the
existing AD. This proposed AD would also require accomplishing the
actions specified in Boeing Alert Service Bulletin DC10-29A148 for
Model DC-10-10, DC-10-10F, DC-10-15, DC-10-30, DC-10-30F (KC-10A and
KDC-10), DC-10-40, and DC-10-40F airplanes.

Change to Existing AD

    This proposed AD would retain all requirements of AD 2004-05-20.
Since AD 2004-05-20 was issued, the AD format has been revised, and
certain paragraphs have been rearranged. As a result, the corresponding
paragraph identifiers have changed in this proposed AD, as listed in
the following table:

                      Revised Paragraph Identifiers
------------------------------------------------------------------------
                                             Corresponding  requirement
       Requirement in AD 2004-05-20             in this  proposed AD
------------------------------------------------------------------------
Paragraph (a).............................  Paragraph (f).
Paragraph (b).............................  Paragraph (g).
------------------------------------------------------------------------

Costs of Compliance

    There are about 409 airplanes of the affected design in the
worldwide fleet. The following table provides the estimated costs for
U.S. operators to comply with this proposed AD.

                                                                     Estimated Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Average                                                    Number of
                                                             labor                                                       U.S.-
               Action                     Work hours        rate per           Parts             Cost per airplane     registered        Fleet cost
                                                              hour                                                     airplanes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Modification (required by AD 2004-   9...................        $80  $4,886 to $7,920......  $5,606 to $8,640......          322  $1,805,132 to
 05-20).                                                                                $2,782,080.
Inspection (required by AD 2004-05-  1...................         80  $0....................  $80, per inspection             322  $25,760, per
 20).                                                                                cycle.                               inspection cycle.
Modification/rerouting (new          2 to 18.............         80  $5,380 to $5,872......  $5,540 to $7,312......          128  $709,120 to $935,936.
 proposed action).
--------------------------------------------------------------------------------------------------------------------------------------------------------

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.
    We are 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

    We have 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. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); 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.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket. See the
ADDRESSES section for a location to examine the regulatory evaluation.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, 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

    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]

    2. The Federal Aviation Administration (FAA) amends Sec.  39.13 by
removing amendment 39-13515 (69 FR 11504, March 11, 2004) and adding
the following new airworthiness directive (AD):

McDonnell Douglas: Docket No. FAA-2008-0735; Directorate Identifier
2008-NM-085-AD.

Comments Due Date

    (a) The FAA must receive comments on this AD action by September
11, 2008.

Affected ADs

    (b) This AD supersedes AD 2004-05-20.

Applicability

    (c) This AD applies to McDonnell Douglas Model DC-10-10, DC-10-
10F, DC-10-15, DC-10-30, DC-10-30F (KC-10A and KDC-10), DC-10-40,
DC-10-40F, MD-10-10F, MD-10-30F, MD-11, and MD-11F airplanes;
certificated in any category; as identified in the applicable
service bulletin listed in Table 1 of this AD.

                                     Table 1.--Airplanes Affected by This AD
----------------------------------------------------------------------------------------------------------------
       McDonnell Douglas model--                Identified in--                     Referenced in--
----------------------------------------------------------------------------------------------------------------
DC-10-10, DC-10-10F, DC-10-15, DC-10-    Boeing Alert Service          Paragraph (f) of this AD.
 30, DC-10-30F (KC-10A and KDC-10), DC-   Bulletin DC10-29A144,
 10-40, DC-10-40F, MD-10-10F, and MD-10-  Revision 2, dated August 1,
 30F airplanes.                           2003.
MD-11 and MD-11F airplanes.............  Boeing Alert Service          Paragraph (g) of this AD.
                                          Bulletin MD11-29A059,
                                          Revision 2, dated August 1,
                                          2003.
DC-10-10, DC-10-10F, DC-10-15, DC-10-    Boeing Alert Service          Paragraph (h) of this AD.
 30, DC-10-30F (KC-10A and KDC-10), DC-   Bulletin DC10-29A148, dated
 10-40, and DC-10-40F airplanes.          March 20, 2008.
----------------------------------------------------------------------------------------------------------------

Unsafe Condition

    (d) This AD results from reports of failure of the electric
motor for the auxiliary hydraulic pump. We are issuing this AD to
prevent failure of the electric motors of the hydraulic pump and
associated wiring, which could result in fire at the auxiliary
hydraulic pump and consequent damage to the adjacent electrical
equipment and/or structure.

Compliance

    (e) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Restatement of the Requirements of AD 2004-05-20

Modification/Prior or Concurrent Actions

    (f) For Model DC-10-10, DC-10-10F, DC-10-15, DC-10-30, DC-10-30F
(KC-10A and KDC-10), DC-10-40, DC-10-40F, MD-10-10F, and MD-10-30F
airplanes listed in Boeing Alert Service Bulletin DC10-29A144,
Revision 2, dated August 1, 2003: Within 18 months after April 15,
2004 (the effective date of AD 2004-05-20), do the actions specified
in paragraphs (f)(1) and (f)(2) of this AD.
    (1) Modify the installation wiring of the electric motor
operated auxiliary hydraulic pumps in the right wheel well area of
the main landing gear (MLG) (including removing existing clamps,
ground wires, if required, and sleeving from the wire assemblies;
inspecting for cracks and chafing, installing new support bracket,
clips, and bracket assemblies, as applicable; installing sleeving;
re-routing and attaching wire assemblies using new clamps and
attachments; installing an additional routing clip on the lower
bracket of the fuel motor control valve, if applicable; and doing a
voltage check and a functional test), per the Accomplishment
Instructions of Boeing Alert Service Bulletin DC10-29A144, Revision
2, dated August 1, 2003.
    (2) Prior to or concurrently with accomplishment of paragraph
(f)(1) or (h) of this AD: Do the actions specified in Boeing Alert
Service Bulletin DC10-29A142, Revision 02, dated April 17, 2003; or
Revision 3, dated October 15, 2005; (including inspecting the
numbers 1 and 2 electric motors of the auxiliary hydraulic pumps for
electrical resistance, continuity, mechanical rotation, and
associated airplane wiring resistance/voltage; and replacing the
auxiliary hydraulic pump with a serviceable pump and repairing the
wiring if necessary), per the Accomplishment Instructions of the
service bulletin. Repeat the actions after that at intervals not to
exceed 2,500 flight hours. After the effective date of this AD,
Revision 3 must be used.
    (g) For Model MD-11 and MD-11F airplanes listed in Boeing Alert
Service Bulletin MD11-29A059, Revision 2, dated August 1, 2003:
Within 18 months after April 15, 2004, do the actions specified in
paragraphs (g)(1) and (g)(2) of this AD.
    (1) Modify the installation wiring of the electric motor
auxiliary hydraulic pumps in the wheel well area of the right MLG
(including removing and retaining wire assembly clamps, if
applicable; retaining the existing ground wire assemblies; retaining
or replacing all other wire assemblies for both connectors;
installing spiral wrap and sleeving; wrapping upper ends of
individual wires with tape; installing new support bracket
assemblies, if applicable; re-routing and attaching wire assemblies
using new clamps and attachments, if applicable; and doing a voltage
check and a functional test), per the Accomplishment Instructions of
Boeing Alert Service Bulletin MD11-29A059, Revision 2, dated August
1, 2003.
    (2) Prior to or concurrently with accomplishment of paragraph
(g)(1) of this AD: Do the actions specified in Boeing Alert Service
Bulletin MD11-29A057, Revision 02, dated April 17, 2003 (including
inspecting the numbers 1 and 2 electric motors of the auxiliary
hydraulic pumps for electrical resistance, continuity, mechanical
rotation, and associated airplane wiring resistance/voltage; and
replacing the auxiliary hydraulic pump with a serviceable pump and
repairing the wiring if necessary), per the Accomplishment
Instructions of the service bulletin. Repeat the actions after that
at intervals not to exceed 2,500 flight hours.

New Requirements of This AD

Modification and Rerouting

    (h) For Model DC-10-10, DC-10-10F, DC-10-15, DC-10-30, DC-10-30F
(KC-10A and KDC-10), DC-10-40, and DC-10-40F airplanes identified in
Boeing Alert Service Bulletin DC10-29A148, dated March 20, 2008:
Within 24 months after the effective date of this AD, modify and
reroute, as applicable, components of the wiring of the electric
motor for the auxiliary hydraulic pump located in the right wheel
well, and do all applicable investigative and corrective actions
before further flight. Do all actions in accordance with the
Accomplishment Instructions of Boeing Alert Service Bulletin DC10-
29A148, dated March 20, 2008. The concurrent requirements, including
the repetitive inspections, of paragraph (f)(2) of this AD continue
to apply to these airplanes.

Alternative Methods of Compliance (AMOCs)

    (i)(1) The Manager, Los Angeles Aircraft Certification Office
(ACO), FAA, has the authority to approve AMOCs for this AD, if
requested in accordance with the procedures found in 14 CFR 39.19.
    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.

    Issued in Renton, Washington, on July 21, 2008.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E8-17198 Filed 7-25-08; 8:45 am]

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