[Federal Register Volume 83, Number 158 (Wednesday, August 15, 2018)]
[Notices]
[Pages 40637-40638]
[FR Doc No: 2018-17588]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2017-0326]

Qualification of Drivers; Exemption Applications; Implantable
Cardioverter Defibrillator (ICD)

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

ACTION: Notice of denials.

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

SUMMARY: FMCSA announces its decision to deny applications from seven
individuals treated with Implantable Cardioverter Defibrillators (ICDs)
who requested an exemption from the Federal Motor Carrier Safety
Regulations (FMCSRs) prohibiting operation of a commercial motor
vehicle (CMV) in interstate commerce by persons with a current clinical
diagnosis of myocardial infarction, angina pectoris, coronary
insufficiency, thrombosis, or any other cardiovascular disease of a
variety known to be accompanied by syncope, dyspnea, collapse, or
congestive heart failure.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER>, [email protected], 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.,
e.t., Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Docket Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE,
Washington, DC, between 9 a.m. and 5 p.m., e.t., Monday through Friday,
except Federal holidays.
    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 http://www.regulations.gov, as described in
the system of records notice (DOT/ALL-14 FDMS), which can be reviewed
at http://www.dot.gov/privacy.

II. Background

    On January 31, 2018, FMCSA published a FR notice (83 FR 4545)
announcing receipt of applications from seven individuals treated with
ICDs and requested comments from the public. These seven individuals
requested an exemption from 49 CFR 391.41(b)(4) which prohibits
operation of a CMV in interstate commerce by persons with a current
clinical diagnosis of myocardial infarction, angina pectoris, coronary
insufficiency, thrombosis, or any other cardiovascular disease of a
variety known to be accompanied by syncope, dyspnea, collapse, or
congestive heart failure. The public comment period closed on May 2,
2018 and one comment was received.
    FMCSA has evaluated the eligibility of these applicants and
concluded that granting these exemptions would not provide a level of
safety that would be equivalent to or greater than, the level of safety
that would be obtained by complying with the regulation 49 CFR
391.41(b)(4). A summary of each applicant's medical history related to
their ICD exemption request was discussed in the March 2, 2018, Federal
Register notice and will not be repeated in this notice.
    In reaching the decision to deny these exemption requests, the
Agency considered information from the Cardiovascular Medical Advisory
Criteria, the April 2007 Evidence Report ``Cardiovascular Disease and
Commercial Motor Vehicle Driver Safety, and a December 2014 focused
research report ``Implantable Cardioverter Defibrillators and the
Impact of a Shock in a Patient When Deployed.'' Copies of the reports
are included in the docket.
    FMCSA has published advisory criteria to assist medical examiners
in determining whether drivers with certain medical conditions are
qualified to operate a CMV in interstate commerce. [Appendix A to Part
391--Medical Advisory Criteria, section D, paragraph 4]. The advisory
criteria for 49 CFR 391.41(b)(4) indicates that coronary artery bypass
surgery and pacemaker implantation are remedial procedures and thus,
not medically disqualifying. Implantable cardioverter defibrillators
are disqualifying due to risk of syncope.

III. Discussion of Comments

    FMCSA received one comment in this proceeding from an individual
who is in favor of any ICD treated individual who has not had any
issues for six months, and who has clearance from their cardiologist,
being allowed to drive a CMV. FMCSA acknowledges the commenters'
responses concerning stable medical histories with ICDs. Based on the
available medical literature cited above, FMCSA believes that a driver
with an ICD is at risk for incapacitation if the device discharges.
This risk is combined with the risks associated with the underlying
cardiovascular condition for which the ICD has been implanted as a
primary or secondary preventive measure.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption if
it finds such an exemption would likely achieve a level of safety that
is equivalent to, or greater then, the level that would be achieved
absent such an exemption.
    The Agency's decision regarding these exemption applications is
based on an individualized assessment of each applicant's medical
information provided by the applicant, available medical and scientific
data concerning ICD's, and public comments received.
    In the case of persons with ICDs, the underlying condition for
which the ICD was implanted places the individual at high risk for
syncope (a transient loss of consciousness) or other unpredictable
events known to result in gradual or sudden incapacitation. ICDs may
discharge, which could result in loss of ability to safely control a
CMV. See the April 2007 Evidence Report on Cardiovascular Disease and
Commercial Motor vehicle Driver Safety, April 2007.\1\ A focused
research report on Implantable Cardioverter Defibrillators and the
Impact of a Shock on a Patient When Deployed completed for the FMCSA
December 2014 indicates that the available scientific data on persons
with ICDs and CMV driving does not support that persons with ICDs who

operate CMVs are able to meet an equal or greater level of safety and
upholds the findings of the April 2007 report.
---------------------------------------------------------------------------

    \1\ Now available at http://ntl.bts.gov/lib/30000/30100/30123/Final_CVD_Evidence_Report_v2.pdf.
---------------------------------------------------------------------------

V. Conclusion

    The Agency has determined that the available medical and scientific
literature and research provides insufficient data to enable the Agency
to conclude that granting these exemptions would achieve a level of
safety equivalent to, or greater than, the level of safety maintained
without the exemption. Therefore, the following seven applicants have
been denied exemptions from the physical qualification standards in 49
CFR 391.41(b)(4):

Frank D'Ercole (NJ)
Myles Goodwin (NH)
Cody Hairr (NC)
Dennis R. Pickett (IN)
William E. Richardson, Jr. (MI)
Terry Stephens ( VA)
Jeffrey A. Weiner ( MN)

    Each applicant has, prior to this notice, received a letter of
final disposition regarding his/her exemption request. Those decision
letters fully outlined the basis for the denial and constitutes final
action by the Agency. The list published today summarizes the Agency's
recent denials as required under 49 U.S.C. 31315(b)(4).

    Issued on: August 8, 2018.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2018-17588 Filed 8-14-18; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 88, Number 98 (Monday, May 22, 2023)]
[Proposed Rules]
[Pages 32713-32715]
[FR Doc No: 2023-10765]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2023-0364]
RIN 1625-AA00

Safety Zone; Monongahela River Mile Marker 122-122.5, Rivesville,
WV

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard is proposing to establish a temporary safety
zone for the Monongahela River at mile marker 122-122.5 from 10 p.m.
through 10:30 p.m. This action is necessary to provide for the safety
of life on these navigable waters during firework display on July 2,
2023. This proposed rulemaking would prohibit persons and vessels from
being in the safety zone unless authorized by the Captain of the Port
Pittsburgh (COTP) or a designated representative. We invite your
comments on this proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before June 21, 2023.

ADDRESSES: You may submit comments identified by docket number USCG-
2023-0364 using the Federal Decision-Making Portal at https://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email LTJG Eyobe

Mills, Marine Safety Unit Pittsburgh, U.S. Coast Guard; at telephone
412-221-0807 ext. 225, email Eyobe.D. [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    On April 11, 2023, the Town of Rivesville notified the Coast Guard
that it will be conducting a firework show display from 10 p.m. through
10:30 p.m. on July 2, 2023. The firework display will be conducted on
land and the fallout zone will be approximately 100 feet into the
Monongahela River. Hazards from the firework show displays include
dangerous projectiles and falling firework debris.
    The purpose of this rulemaking is to ensure the safety of vessels
and the navigable waters within the safety zone before, during, and
after the scheduled event. The Coast Guard is proposing this rulemaking
under authority in 46 U.S.C. 70034.

III. Discussion of Proposed Rule

    The COTP is proposing to establish a temporary safety zone from 10
p.m. through 10:30 p.m. on July 2, 2023. The safety zone would cover
all navigable waters on the Monongahela River from mile 122 to mile
122.5. The duration of the zone is intended to ensure the safety of
vessels and these navigable waters before, during, and after the
scheduled firework display. No vessel or person would be permitted to
enter the safety zone without obtaining permission from the COTP or a
designated representative. The regulatory text we are proposing appears
at the end of this document.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes and Executive orders, and
we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This NPRM has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, the NPRM
has not been reviewed by the Office of Management and Budget (OMB).
    This regulatory action determination is based on size, location,
and duration of the temporary safety zone. This safety zone impacts 0.5
miles stretch of the Monongahela River for a short amount of time of 30
minutes on one evening. Vessel traffic will be informed about the
safety zone through local notice to mariners. Moreover, the Coast Guard
will issue Local Notice to Marines, Broadcast Notice to Mariner via
VHF-FM marine channel 16 about the zone and the rule allows vessels to
seek permission from the COTP to transit the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit the
temporary safety zone may be small entities, for the reasons stated in
section IV.A above, this proposed rule would not have a significant
economic impact on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this proposed rule
would have a significant economic impact on it, please submit a comment
(see ADDRESSES) explaining why you think it qualifies and how and to
what degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the proposed rule
would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please call or email the person listed in the
FOR FURTHER INFORMATION CONTACT section. The Coast Guard will not
retaliate against small entities that question or complain about this
proposed rule or any policy or action of the Coast Guard.

C. Collection of Information

    This proposed rule would not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132
(Federalism), if it has 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. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this proposed rule does not have Tribal implications under
Executive Order 13175 (Consultation and Coordination with Indian Tribal
Governments) because it would not have a substantial direct effect on
one or more Indian Tribes, on the relationship between the Federal
Government and Indian Tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian Tribes. If
you believe this proposed rule has implications for federalism or
Indian Tribes, please call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule would not
result in such an expenditure, we do discuss the potential effects of
this proposed rule elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Directive 023-01, Rev. 1, associated implementing
instructions, and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made
a preliminary determination

that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This proposed rule involves a temporary safety zone
lasting 30 minutes that would prohibit entry within the Monongahela
River from mile 122 to mile 122.5. Normally such actions are
categorically excluded from further review under paragraph L[60a] of
Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A
preliminary Record of Environmental Consideration supporting this
determination is available in the docket. For instructions on locating
the docket, see the ADDRESSES section of this preamble. We seek any
comments or information that may lead to the discovery of a significant
environmental impact from this proposed rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places, or vessels.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    Submitting comments. We encourage you to submit comments through
the Federal Decision-Making Portal at https://www.regulations.gov. To
do so, go to https://www.regulations.gov, type USCG-2023-0364 in the
search box and click ``Search.'' Next, look for this document in the
Search Results column, and click on it. Then click on the Comment
option. If you cannot submit your material by using https://www.regulations.gov, call or email the person in the FOR FURTHER
INFORMATION CONTACT section of this proposed rule for alternate
instructions.
    Viewing material in docket. To view documents mentioned in this
proposed rule as being available in the docket, find the docket as
described in the previous paragraph, and then select ``Supporting &
Related Material'' in the Document Type column. Public comments will
also be placed in our online docket and can be viewed by following
instructions on the https://www.regulations.gov Frequently Asked
Questions web page. Also, if you click on the Dockets tab and then the
proposed rule, you should see a ``Subscribe'' option for email alerts.
The option will notify you when comments are posted, or a final rule is
published.
    We review all comments received, but we will only post comments
that address the topic of the proposed rule. We may choose not to post
off-topic, inappropriate, or duplicate comments that we receive.
    Personal information. We accept anonymous comments. Comments we
post to https://www.regulations.gov will include any personal
information you have provided. For more about privacy and submissions
to the docket in response to this document, see DHS's eRulemaking
System of Records notice (85 FR 14226, March 11, 2020).

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard is
proposing to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 46 U.S.C. 70034, 70051, 70124; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.3.

0
2. Add Sec.  165.T08-0364 to read as follows:

Sec.  165.T08-0364  Safety Zone; Monongahela River, Miles 122-122.5,
Rivesville, WV.

    (a) Location. The following area is a temporary safety zone: all
navigable waters of the Allegheny River from mile 122 to mile 122.5.
    (b) Definitions. As used in this section, designated representative
means a Coast Guard Patrol Commander, including a Coast Guard coxswain,
petty officer, or other officer operating a Coast Guard vessel and a
Federal, State, and local officer designated by or assisting the
Captain of the Port Pittsburgh (COTP) in the enforcement of the safety
zone.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) To seek permission to enter, contact the COTP or the COTP's
representative by phone at<PHONE_NUMBER>. Those in the safety zone must
comply with all lawful orders or directions given to them by the COTP
or the COTP's designated representative.
    (d) Enforcement period. This section will be enforced from 10 p.m.
through 10:30 p.m. on July 2, 2023.

Eric J. Velez.
Commander, U.S. Coast Guard, Captain of the Port Marine Safety Unit
Pittsburgh.
[FR Doc. 2023-10765 Filed 5-19-23; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 81, Number 164 (Wednesday, August 24, 2016)]
[Proposed Rules]
[Pages 57812-57816]
[FR Doc No: 2016-19876]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16 and 511

[Docket No. FDA-2011-N-0079]

Disqualification of a Clinical Investigator

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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

SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
the regulations for new animal drugs for investigational use to expand
the scope of clinical investigator disqualification to include
ineligibility to conduct nonclinical laboratory studies. Currently,
when the Commissioner of Food and Drugs (the Commissioner) determines
that an investigator is ineligible to receive a new animal drug for
investigational use, the investigator also is ineligible to conduct any
clinical investigation that supports an application for a research or
marketing permit for products regulated by FDA. Under this proposal,
when the Commissioner determines that an investigator is ineligible to
receive a new animal drug for investigational use, the investigator
also will be ineligible to conduct any nonclinical study intended to
support an application for a research or marketing permit for a new
animal drug. This proposal is intended to help ensure adequate
protection of animal research subjects and the quality and integrity of
data submitted to FDA.

DATES: Submit either electronic or written comments on the proposed
rule by November 22, 2016. See section VII of this document for the
proposed effective date of a final rule based on this document.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the

instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2011-N-0079 for ``Disqualification of a Clinical Investigator.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the guidance to the
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Vernon Toelle, Center for Veterinary
Medicine (HFV-230), 7519 Standish Pl., Rockville, MD 20855, 240-402-
5637.

SUPPLEMENTARY INFORMATION:

I. Introduction

    The current regulations in part 511 (21 CFR part 511) prohibit a
disqualified clinical investigator from conducting any clinical
investigation that supports an application for a research or marketing
permit for products regulated by FDA. We propose to expand the current
clinical investigator disqualification regulations in part 511 by
providing that a disqualified investigator also is ineligible to
conduct any nonclinical laboratory study intended to support an
application for a research or marketing permit for a new animal drug.
In this document, consistent with our proposal in part 58 (21 CFR part
58) published elsewhere in this issue of the Federal Register, the term
``nonclinical laboratory study'' means in vivo or in vitro experiments
in which test articles are studied prospectively in test systems under
laboratory conditions or in the applicable environment to determine
their safety or toxicity or both. The term does not include studies
involving human subjects, clinical studies, or clinical investigational
use in animals. The term does not include basic exploratory studies
carried out to determine whether a test article has any potential
utility or basic exploratory studies to determine the physical or
chemical characteristics of a test article.
    Under current Sec.  511.1(c) (21 CFR 511.1(c)), a clinical
investigator disqualified by the Commissioner is ineligible to receive
the test article regulated in part 511 (i.e., a new animal drug for
investigational use). Also, under the current regulations in Sec.
511.1(c), a disqualified clinical investigator is ineligible to conduct
any clinical investigation that supports an application for a research
or marketing permit for products regulated by FDA. However, under the
current regulations, a disqualified clinical investigator continues to
be eligible to conduct a nonclinical laboratory study intended to
support an application for a research or marketing permit for a new
animal drug.
    In order to conclude that a clinical investigator is no longer
eligible to receive new animal drugs for investigational use, the
Commissioner must find that the investigator repeatedly or deliberately
failed to comply with the conditions of the exempting regulations or
repeatedly or deliberately submitted to FDA or to the sponsor false
information in any required report (Sec.  511.1(c)(2)). When a clinical
investigator is disqualified under part 511, the basis for
disqualification typically is the repeated or deliberate submission of
false information to FDA or a sponsor in a required report. For new
animal drugs, the same clinical investigator could conduct both
nonclinical laboratory studies and clinical investigations.
    In the new animal drug approval process, nonclinical laboratory
studies such as those for target animal safety and human food safety
may be essential in determining whether to approve an application for a
research or marketing permit for a new animal drug. Therefore, this
proposal to expand Sec.  511.1(c) to include nonclinical laboratory
studies is intended to help ensure adequate protection of animal
research subjects and the quality and integrity of data submitted to
FDA for the approval of a new animal drug.

    Consistent with the proposed changes to the provisions in part 511,
we propose amending the list of regulatory provisions under which a
part 16 (21 CFR part 16) informal regulatory hearing is available. In
part 16, we propose changing the scope of the relevant provision for
part 511 to add ``any nonclinical laboratory study intended to support
an application for a research or marketing permit for a new animal
drug.''
    Concurrent with this proposal, FDA is publishing elsewhere in this
issue of the Federal Register a related provision in part 58. We
propose in Sec.  58.206 (21 CFR 58.206) that a disqualified person
under part 58, who is a clinical investigator, would be notified that
they are ineligible to receive a test article under part 511. Thus,
where this part 511 proposal would make a disqualified clinical
investigator ineligible to conduct any nonclinical laboratory study
intended to support an application for a research or marketing permit
for a new animal drug, the proposal in Sec.  58.206 would make a
disqualified person under part 58, who is a clinical investigator,
ineligible to receive a test article under part 511. An investigator
ineligible to receive a test article under part 511 also would be
ineligible to conduct any nonclinical laboratory study intended to
support an application for a research or marketing permit for a new
animal drug. We propose this action in Sec.  58.206 to help protect the
safety and welfare of animal research subjects involved in FDA-
regulated nonclinical laboratory studies and clinical investigations,
and to help ensure the reliability and integrity of the data submitted
to FDA to support FDA decisions concerning new animal drugs.

II. Background

    FDA may consider disqualification of a clinical investigator when
FDA has information that an investigator has repeatedly or deliberately
failed to comply with applicable requirements for the conduct of
clinical investigations, or has repeatedly or deliberately submitted to
FDA or to the sponsor false information in any required report.
Disqualification of an investigator is initiated by the appropriate FDA
Center depending upon the particular type of test article (e.g., new
animal drug for investigational use) under study by the investigator in
the clinical investigation. For example, the Center for Veterinary
Medicine (CVM) may pursue disqualification of a clinical investigator
who conducted a new animal drug clinical investigation and allegedly
submitted to FDA or the sponsor false information in a required report.
    The regulations provide the investigator, who is subject to
disqualification, an opportunity to be heard and explain the matter
complained of, i.e., explain the alleged violations. If the explanation
offered is not accepted by the Center, the investigator will be given
an opportunity for an informal regulatory hearing under part 16. After
evaluating all available information, including any explanation
presented by the investigator, the Commissioner issues a Commissioner's
decision regarding the eligibility of the investigator to receive a
particular type of test article (e.g., a new animal drug for
investigational use). When disqualified by a Commissioner's decision,
the investigator is no longer eligible to receive the particular type
of test article under study when the violations occurred (e.g., new
animal drugs). Also, under current regulations, an investigator
disqualified by a Commissioner's decision is ineligible to conduct any
clinical investigation that supports an application for a research or
marketing permit for products regulated by FDA.
    Because CVM regulates drugs for animal use, the study subjects are
animals in both nonclinical laboratory studies and clinical
investigations intended to support the approval of a new animal drug.
Nonclinical laboratory studies such as those for target animal safety
and human food safety may be essential in determining whether to
approve an application for a research or marketing permit for a new
animal drug. For animal drug products regulated by CVM, the same
investigator may conduct both nonclinical laboratory studies and
clinical investigations. For example, CVM's two most recent clinical
investigator disqualification matters involved investigators who were
also study directors on nonclinical laboratory studies submitted to CVM
in support of applications for a new animal drug. In addition, CVM is
aware of multiple persons that conduct both clinical investigations and
nonclinical laboratory studies intended to support an application for a
research or marketing permit for a new animal drug. Therefore, it is
critical for CVM to have the authority to disqualify an investigator
from conducting nonclinical laboratory studies when that same
investigator is disqualified from conducting clinical investigations,
particularly when the basis for disqualification is the repeated or
deliberate submission of false information to FDA or the sponsor in a
required report.
    This proposal to amend part 511 to expand a disqualified
investigator's ineligibility to conduct any nonclinical laboratory
study intended to support an application for a research or marketing
permit for a new animal drug would help to ensure adequate protection
of animal research subjects and data integrity. This action also may
lead to improved public confidence in the nonclinical and clinical data
supporting FDA decisions for new animal drug approvals.
    We therefore propose that when the Commissioner determines that a
clinical investigator is ineligible to receive the test article under
the disqualification regulations in part 511 and is therefore
ineligible to conduct any clinical investigation that supports an
application for a research or marketing permit for products regulated
by FDA, the investigator also would be ineligible to conduct any
nonclinical laboratory study intended to support an application for a
research or marketing permit for a new animal drug.
    To effect this change, FDA proposes to amend the current
regulations in Sec.  511.1(c).

III. Description of the Proposed Rule

A. Disqualification Proceedings (Sec.  511.1(c)(1))

    Proposed Revisions to Sec.  511.1(c)(1): We propose to change the
scope of the question addressed during a part 16 hearing, should the
investigator request and be granted an informal hearing, also to
include whether the investigator is eligible to conduct any nonclinical
laboratory study that is intended to support an application for a
research or marketing permit for a new animal drug.

B. Ineligibility To Receive Any Test Article (Sec.  511.1(c)(2))

    Proposed Revisions to Sec.  511.1(c)(2): We propose that an
investigator disqualified by a Commissioner's decision also will be
ineligible to conduct any nonclinical laboratory study that is intended
to support an application for a research or marketing permit for a new
animal drug.
    Therefore, as proposed, an investigator determined to be ineligible
to receive a test article under part 511 also would be ineligible to
conduct any nonclinical laboratory study intended to support an
application for a research or marketing permit for a new animal drug.
This proposal expands the scope of the current regulations in Sec.
511.1(c)(2) which states that a disqualified clinical investigator is
ineligible to conduct any

clinical investigation that supports an application for a research or
marketing permit for products regulated by FDA, including drugs,
biologics, devices, new animal drugs, foods, including dietary
supplements, that bear a nutrient content claim or a health claim,
infant formulas, food and color additives, and tobacco products.

C. Reinstatement (Sec.  511.1(c)(6))

    FDA proposes amending Sec.  511.1(c)(6) for consistency with our
proposal to add ``any nonclinical laboratory study intended to support
an application for a research or marketing permit for a new animal
drug'' to the part 511 investigator disqualification regulations.
Therefore, for consistency with the proposed changes in Sec.
511.1(c)(2), we propose adding in Sec.  511.1(c)(6) that the
investigator has presented adequate assurances that the investigator
will conduct any nonclinical laboratory study intended to support an
application for a research or marketing permit for a new animal drug
solely in compliance with the applicable provisions of chapter I.

IV. Regulatory Hearing before the Food and Drug Administration

    We propose to revise Sec.  16.1(b)(2) to amend the entry for Sec.
511.1(c)(1) to add ``any nonclinical laboratory study intended to
support an application for a research or marketing permit for a new
animal drug'' to be consistent with the other proposed amendments in
this rulemaking.

V. Environmental Impact

    We have determined under 21 CFR 25.30(h) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VI. Legal Authority

    Under section 701(a) of the FD&C Act (21 U.S.C. 371(a)), FDA is
authorized to issue regulations for the efficient enforcement of the
FD&C Act. Section 512(j) of the FD&C Act (21 U.S.C. 355(j)) authorizes
FDA to issue regulations for exempting from the operation of section
512 of the FD&C Act new animal drugs intended solely for
investigational use by experts qualified by scientific training and
experience to investigate the safety and effectiveness of animal drugs.
An investigator who repeatedly or deliberately violates the regulations
or who repeatedly or deliberately submits to FDA or the sponsor false
information in a required report would not be considered a qualified
expert with the experience required to conduct nonclinical laboratory
studies intended to support an application for a research or marketing
permit for a new animal drug. This proposed rulemaking would disqualify
a clinical investigator from conducting nonclinical laboratory studies
intended to support an application for a research or marketing permit
for a new animal drug when the Commissioner determines that a clinical
investigator is ineligible to receive the test article under the
disqualification regulations in part 511. FDA's legal authority to
promulgate this proposal regarding clinical investigators exists under
sections 512(j) and 701(a) of the FD&C Act, as essential to protection
of the public health and safety and to enforcement of the Agency's
responsibilities under sections 201, 501, 502, 503, 512, and 701 of the
FD&C Act (21 U.S.C. 321, 351, 352, 353, 360b, and 371).

VII. Proposed Effective Date

    FDA proposes that any final rule that may issue based on this
proposal become effective 30 days after the date of publication of the
final rule in the Federal Register.

VIII. Preliminary Economic Analysis

    FDA has examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Agency believes that this proposed rule is not a
significant regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this proposed rule does not impose new
requirements on any entity and therefore has no associated compliance
costs, the Agency proposes to certify that the final rule will not have
a significant economic impact on a substantial number of small
entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $144 million, using the most current (2014) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.
    This proposed rule seeks to expand the scope in part 511 of
disqualification of a clinical investigator to include ineligibility to
conduct nonclinical laboratory studies. A final rule (77 FR 25353),
published on April 30, 2012, prevents a disqualified investigator from
conducting any clinical investigation, and therefore applies explicitly
to clinical investigations. However, the rule is silent on nonclinical
laboratory studies. Thus, under the current regulation in part 511, a
disqualified investigator could conduct a nonclinical laboratory study
intended to support an application for a research or marketing permit
for a new animal drug. Because the reason typically for
disqualification in part 511 is the repeated or deliberate submission
of false information to FDA or a sponsor in a required report,
preventing a disqualified clinical investigator from performing both
nonclinical laboratory studies and clinical investigations is essential
to adequate protection of animal research subjects and data integrity.
    The Agency would not incur additional costs by expanding the scope
in part 511 for disqualification of a clinical investigator. Similarly,
we do not expect that industry would incur additional costs because the
proposed rule would not require sponsors to perform additional tasks.
For instance, upon disqualification, the respective investigator's name
is posted on FDA's Web page, and this helps mitigate the employment of
the investigator for clinical investigations or nonclinical laboratory
studies intended to support an application for a research or marketing
permit for a new animal drug. Because the typical reason for
disqualification in part 511 is the repeated or deliberate submission
of false information to FDA or a sponsor in a required report, the
benefit of preventing a disqualified clinical investigator from
performing both nonclinical laboratory studies and clinical
investigations is enhanced protection of animal research subjects and
data integrity.

IX. Paperwork Reduction Act

    FDA tentatively concludes that this proposed rule contains no
collection of information. Therefore, clearance by OMB under the
Paperwork Reduction Act of 1995 is not required.

X. Federalism

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
the proposed rule, if finalized, would not contain policies that would
have substantial direct effects 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.
Accordingly, the Agency tentatively concludes that the proposed rule
does not contain policies that have federalism implications as defined
in the Executive order and, consequently, a federalism summary impact
statement is not required.

List of Subjects

21 CFR Part 16

    Administrative practice and procedure.

21 CFR Part 511

    Animal drugs, Medical research, Reporting and recordkeeping
requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that parts 16 and 511 be amended as follows:

PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

0
1. The authority citation for part 16 continues to read as follows:

    Authority:  15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394,
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.

0
2. In Sec.  16.1, in paragraph (b)(2), revise the numerically sequenced
entry for Sec.  511.1(c)(1) to read as follows:

Sec.  16.1  Scope.

* * * * *
    (b) * * *
    (2) * * *
    Sec.  511.1(c)(1), relating to whether an investigator is eligible
to receive test articles under part 511 and eligible to conduct:
    (i) Any clinical investigation that supports an application for a
research or marketing permit for products regulated by FDA including
drugs, biologics, devices, new animal drugs, foods, including dietary
supplements, that bear a nutrient content claim or a health claim,
infant formulas, food and color additives, and tobacco products; and
    (ii) Any nonclinical laboratory study intended to support an
application for a research or marketing permit for a new animal drug.
* * * * *

PART 511--NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE

0
3. The authority citation for part 511 continues to read as follows:

    Authority:  21 U.S.C. 321, 351, 352, 353, 360b, 371.

0
4. In Sec.  511.1, revise the section heading, the last sentences in
paragraphs (c)(1) and (2), and revise paragraph (c)(6) to read as
follows:

Sec.  511.1  New animal drugs for investigational use exempt from
section 512(a) of the Federal Food, Drug, and Cosmetic Act.

* * * * *
    (c) * * *
    (1) * * * If an explanation is offered but not accepted by the
Center for Veterinary Medicine, the investigator will be given an
opportunity for a regulatory hearing under part 16 of this chapter on
the question of whether the investigator is eligible to receive test
articles under this part and eligible to conduct:
    (i) Any clinical investigation that supports an application for a
research or marketing permit for products regulated by FDA; and
    (ii) Any nonclinical laboratory study intended to support an
application for a research or marketing permit for a new animal drug.
    (2) * * * The notification also will explain that an investigator
determined to be ineligible to receive a test article under this part
will be ineligible to conduct
    (i) Any clinical investigation that supports an application for a
research or marketing permit for products regulated by FDA, including
drugs, biologics, devices, new animal drugs, foods, including dietary
supplements, that bear a nutrient content claim or a health claim,
infant formulas, food and color additives, and tobacco products, and
    (ii) Any nonclinical laboratory study intended to support an
application for a research or marketing permit for a new animal drug.
* * * * *
    (6) An investigator who has been determined to be ineligible under
paragraph (c)(2) of this section may be reinstated as eligible when the
Commissioner determines that the investigator has presented adequate
assurances that the investigator will employ all test articles, and
will conduct any clinical investigation that supports an application
for a research or marketing permit for products regulated by FDA and
any nonclinical laboratory study intended to support an application for
a research or marketing permit for a new animal drug, solely in
compliance with the applicable provisions of this chapter.
* * * * *

    Dated: August 16, 2016.
Peter Lurie,
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2016-19876 Filed 8-23-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 143 (Thursday, July 27, 2017)]
[Rules and Regulations]
[Pages 34844-34846]
[FR Doc No: 2017-15552]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0174; Directorate Identifier 2014-SW-059-AD;
Amendment 39-18973; AD 2017-15-13]
RIN 2120-AA64

Airworthiness Directives; Bell Helicopter Textron Canada Limited

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for Bell
Helicopter Textron Canada Limited (Bell) Model 429 helicopters. This AD
requires reducing the life limit of certain landing gear parts and is
prompted by a stress analysis. The actions of this AD are intended to
address an unsafe condition on these products.

DATES: This AD is effective August 31, 2017.

ADDRESSES: For service information identified in this final rule,
contact Bell Helicopter Textron Canada Limited, 12,800 Rue de l'Avenir,
Mirabel, Quebec J7J1R4; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax
(450) 433-0272; or at http://www.bellcustomer.com/files/. You may
review the referenced service information at the FAA, Office of the
Regional Counsel, Southwest Region, 10101 Hillwood Pkwy, Room 6N-321,
Fort Worth, TX 76177.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0174; or in person at the Docket Operations Office between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the Transport Canada AD, the economic evaluation, any
comments received, and other information. The street address for the
Docket Operations Office (phone:<PHONE_NUMBER>) is U.S. Department of
Transportation, Docket Operations Office, M-30, West Building Ground
Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Matt Fuller, Senior Aviation Safety
Engineer, Safety Management Group, Rotorcraft Directorate, FAA, 10101
Hillwood Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    On March 7, 2017, at 82 FR 12753, the Federal Register published
our notice of proposed rulemaking (NPRM), which proposed to amend 14
CFR part 39 by adding an AD that would apply to Bell Model 429
helicopters. The NPRM proposed to require reducing the life limit of
certain landing gear parts by requiring the removal from service of any
part that has reached or exceeded its new life limit before further
flight. The proposed requirements were intended to prevent failure of a
landing gear part, failure of a landing gear skid, and subsequent loss
of control of the helicopter during takeoff or landing.
    The NPRM was prompted by AD No. CF-2014-28, dated August 19, 2014,
issued by Transport Canada, which is the aviation authority for Canada,
to correct an unsafe condition for Bell Model 429 helicopters, serial
numbers 57001 and subsequent. Transport Canada advises that Bell has
reduced the life limits of several landing gear components and
accordingly revised the airworthiness limitations schedule for Model
429 helicopters. The reduced life limits resulted from a stress
analysis completed by Bell after the introduction of the Model 429
helicopter to service. While the reduced life limits were originally
published in Revision 9 of the Bell Model 429 maintenance manual,
Transport Canada AD No. CF-2014-28 requires inserting the new
airworthiness limitations schedule in Revision 10 of the Bell Model 429
maintenance manual. Transport Canada states that failure to replace
those components prior to the established airworthiness life could
result in an unsafe condition.

Comments

    We gave the public the opportunity to participate in developing
this AD, but we did not receive any comments on the NPRM.

FAA's Determination

    These helicopters have been approved by the aviation authority of
Canada and are approved for operation in the United States. Pursuant to
our bilateral agreement with Canada, Transport Canada, its technical
representative, has notified us of the unsafe condition described in
its AD. We are issuing this AD because we evaluated all information
provided by Transport Canada and determined the unsafe condition exists
and is likely to exist or develop on other helicopters of the same type
design and that air safety and the public interest require adopting the
AD requirements as proposed.

Related Service Information

    We reviewed Bell Model 429 Maintenance Manual BHT-429-MM-1, Chapter
4, Airworthiness Limitations Schedule, Revision 9, dated January 6,
2012, which specifies airworthiness life limits and inspection
intervals for parts installed on Model 429 helicopters. Revision 9
reduced the life limits for the skid tube assemblies, forward crosstube
assembly, and aft crosstube assembly.

Costs of Compliance

    We estimate that this AD affects 71 helicopters of U.S. Registry.
We estimate that operators may incur the following costs in order to
comply with this AD. Labor costs are estimated at $85 per work-hour.
Calculating the life limit will take about 0.25 work-hour for an
estimated cost of $21 per helicopter and $1,491 for the U.S. fleet.
Replacing a skid tube assembly will take about 2 work-hours and parts
will cost about $7,050 for an estimated replacement cost of $7,220.
Replacing a forward cross tube assembly will take about 1.5 work-hours
and parts will cost about $5,880 for an estimated replacement cost of
$6,008. Replacing an aft tube assembly will take about 1.5 work-hours
and parts will cost $6,710 for an estimated replacement cost of $6,838.

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 helicopters identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will 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 this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866;
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979);
    (3) Will not affect intrastate aviation in Alaska to the extent
that it justifies making a regulatory distinction; and
    (4) 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 an economic evaluation of the estimated costs to comply
with this AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2017-15-13 Bell Helicopter Textron Canada Limited: Amendment 39-
18973; Docket No. FAA-2017-0174; Directorate Identifier 2014-SW-059-
AD.

(a) Applicability

    This AD applies to Bell Helicopter Textron Canada Limited Model
429 helicopters, certificated in any category.

(b) Unsafe Condition

    This AD defines the unsafe condition as a landing gear part
remaining in service beyond its fatigue life. This condition could
result in failure of a landing gear part, failure of a landing gear
skid, and subsequent loss of control of the helicopter during
takeoff or landing.

(c) Effective Date

    This AD becomes effective August 31, 2017.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    Before further flight, determine the accumulated retirement
index number (RIN) for each part and remove it from service if it
has reached or exceeded its life limit as follows. Thereafter,
remove each part from service on or before reaching its life limit.
For purposes of this AD, a run-on landing is defined as a landing
with forward ground travel of the helicopter greater than 3 feet
(0.91 m) with weight on skids.
    (1) For Skid Tube Assembly part number (P/N) 429-700-101, 429-
700-102, and 429-030-586-107: 16,000 RIN. Count 1 RIN for each
landing; count 81 RIN for each run-on landing; and count 117 RIN for
each autorotation landing.
    (2) For Forward Crosstube Assembly P/N 429-712-101: 10,000 RIN.
Count 1 RIN for each landing; count 50 RIN for each run-on landing;
and count 118 RIN for each autorotation landing.
    (3) Aft Crosstube Assembly P/N 429-723-108: 30,000 RIN. Count 1
RIN for each landing; count 32 RIN for each run-on landing; and
count 186 RIN for each autorotation landing.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs
for this AD. Send your proposal to: Matt Fuller, Senior Aviation
Safety Engineer, Safety Management Group, Rotorcraft Directorate,
FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817)
222-5110; email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office, before operating any aircraft
complying with this AD through an AMOC.

(g) Additional Information

    (1) Bell 429 Maintenance Manual BHT-429-MM-1, Volume 1, Chapter
4, Revision 9, dated January 6, 2012, which is not incorporated by
reference, contains additional information about the subject of this
AD. For service information identified in this AD, contact Bell
Helicopter Textron Canada Limited, 12,800 Rue de l'Avenir, Mirabel,
Quebec J7J1R4; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax (450)
433-0272; or at http://www.bellcustomer.com/files/. You may review a
copy of the service information at the FAA, Office of the Regional
Counsel, Southwest Region, 10101 Hillwood Pkwy, Room 6N-321, Fort
Worth, TX 76177.
    (2) The subject of this AD is addressed in Transport Canada AD
No. CF-2014-28, dated August 19, 2014. You may view the Transport
Canada AD on the Internet at http://www.regulations.gov in Docket
No. FAA-2017-0174.

(h) Subject

    Joint Aircraft Service Component (JASC) Code: 3200, Landing Gear
System.

    Issued in Fort Worth, Texas, on July 18, 2017.
Scott A. Horn,
Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2017-15552 Filed 7-26-17; 8:45 am]
BILLING CODE 4910-13-P


7.3 Zero Values For each numeric field in each table, a count was made of the number of records containing a zero value. A record was inserted in a new table for each field which contained the table name, field name, and count of zero values. These records were reviewed to ensure that fields for which zero values were not expected were not included in the table. 7 2 7.4 Table Relationships For each field in each table with a Child to Parent relationship, a count was made of the number of records not having a matching parent record. A record was inserted in a new table for each field which contained table name, field name and count of records missing a parent record. These records were reviewed to ensure that tables for which missing parent records were not expected were not included in the table.

Likewise, for each field in each table with a Parent to Child relationship, a count was made of the number of records not having a matching child record. If this count was greater than zero, a record was inserted in a new table which contained the parent table name, child table name, field name, and the value of the field without a matching child record. These records were reviewed to ensure that tables for which missing child records were not expected were not included in the table. 8 1 8.0 REFERENCES AAMA, 1999. North American Gasoline and Diesel Fuel Survey. Alliance of Automobile Manufacturers.

Abt, 2003. Refinery Modeling: Legislative and Regulatory Developments   Effects on Gasoline Supply, Federal Oxygenate Case and Fuel Control Cases ( Benzene, Toxics and Sulfur Control). EPA Contract 68 C 01 164, Work Assignment 1 7 & 1 7.1, Sub Tasks 3.2, 4.1, and 4.2 for 2010. Prepared for U. S. Environmental Protection Agency by Abt Associates Inc., Bethesda, Maryland. January 14.

Federal Register, 2000. Control of Air Pollution From New Motor Vehicles: Tier 2 Motor Vehicle Emissions Standards and Gasoline Sulfur Control Requirements. Final Rule. 65 CFR 6698. February 10.

Federal Register, 2001. Control of Air Pollution From New Motor Vehicles; Amendment to the Tier 2/ Gasoline Sulfur Regulations. Direct Final Rule. 66 CFR 19296. April 13.

FHWA, 1999. Federal Highway Administration ( FHWA) website for oxygenated fuel sale percentage. Table MF 33E   Estimated Use of Gasohol and Table MF 21   Motor Fuel Use. Internet address: http:// www. fhwa. dot. gov/ ohim/ hs99/ mfpage. htm Manners, 2002. Personal communication between Mary Manners ( U. S. EPA, Ann Arbor, Michigan; 734 214 4873) and Marty Wolf ( ERG). August 23.

MathPro, 1998. Costs of Alternative Sulfur Content Standards for Gasoline in PADD IV. Final Report. Prepared for the National Petrochemical and Refiners Association by MathPro Inc., West Bethesda, Maryland. December 30.

MathPro, 1999a. Costs of Meeting 40 PPM Sulfur Content Standard for Gasoline in PADDS 1 3, Via Mobil and CD Tech Desulfurization Processes. Final Report. Prepared for the American Petroleum Institute by MathPro Inc., West Bethesda, Maryland. February 26.

MathPro, 1999b. Analysis of California Phase 3 RFG Standards. Prepared for the California Energy Commission by MathPro Inc., West Bethesda, Maryland. December 7.

TRW, 1999. National Institute of Petroleum and Energy Research ( NIPER or TRW) Fuel Survey.

U. S. EPA, 2000. Reformulated Gasoline Survey Data for 2000. U. S. Environmental Protection Agency, Office of Transportation and Air Quality, Ann Arbor, Michigan. Internet address: http:// www. epa. gov/ otaq/ consumer/ fuels/ mtbe/ oxy 95 00. pdf. 8 2 U. S. EPA, 2001. U. S. EPA Oxygenated Fuel Program Summary, State Winter Oxygenated Fuel Program Requirements for Attainment or Maintenance of CO NAAQS, U. S. Environmental Protection Agency, Office of Transportation and Air Quality, Ann Arbor, Michigan. October. Internet address: http:// www. epa. gov/ otaq/ regs/ fuels/ oxy area. pdf.

U. S. EPA, 2002a. Technical Description of the Toxics Module for MOBILE6.2 and Guidance on Its Use for Emission Inventory Preparation. EPA420 R 02 029. U. S. Environmental Protection Agency, Office of Transportation and Air Quality, Ann Arbor, Michigan. November.

U. S. EPA, 2002b. MOBILE6.2 User's Guide. EPA 420 R 02 028. U. S. Environmental Protection Agency, Office of Transportation and Air Quality, Ann Arbor, Michigan. October. A 1 APPENDIX A INDEX TO DATA FILES AVAILABLE ELECTRONICALLY NMIM Table Name File Name Description Reference Tables Folder HPMSRoadType vehicles2. xls The spreadsheet was taken from the June 2002 National Emissions Inventory ( NEI) update files.

M6VType Appendix B of MOBILE6 User's Guide The 16 vehicle classes were obtained from Table 2 of Appendix B ( pg 245) of the MOBILE6 User's Guide ( EPA420 R 02 028, October 2002).

M6VClass Appendix B of MOBILE6 User's Guide The 16 vehicle classes were obtained from Section 1.2.3 ( pg 14) of the MOBILE6 User's Guide ( EPA420 R 02 028, October 2002).

Fuel Tables Folder CountyYearMonth Gasoline Gasoline2 CYMMTBEPhsOut GasMTBEPhsOut Gas2MTBEPhsOut CYM_ Gas. mdb CYM_ GasMTBE. mdb 030425_ gasoline assignments and parameters. xls Final_ Fuel1999V3_ 032 703. xls RFG_ Fuel00_ v1. xls Access 97 databases which produces the CountyYearMonth, Gasoline, Gasoline2, CYMMTBEPhsOut, GasMTBEPhsOut, and Gas2MTBEPhsOut tables. The user can open the form frmExecFunctions in each database and click the buttons in order to re create the data. The queries with names beginning " Export_" should be imported into the County database. Gasoline assignments and factors for 1999 through 2050.

1999 seasonal gasoline parameters by county Updated seasonal gasoline parameters by county for year 2000.

Diesel sulfur. xls The spreadsheet contains the assumptions Pechan used for non road sulfur content of diesel and CNG fuels, forwarded by Dave Brzezinski, EPA. [ two additional records were added, where did they come from?]

NaturalGas sulfur. xls The spreadsheet contains the assumptions Pechan used for non road sulfur content of diesel and CNG fuels, forwarded by Dave Brzezinski, EPA.

I/ M Program Tables Folder NMIM Table Name File Name Description A 2 CountyYear stage2dat. xls 00tables. wpd trends99_ pointer. dbf trends99_ im. xls model. wpd counties. wpd IMFiles\*.* 1999 Updated M6 Input Files\*.* Fall 2001 update to the 1999 NEI files: Stage 2 refueling program efficiency ( stage2dat. xls, 00tables. wpd), Anti tampering program file name and files ( trends99_ pointer. dbf), I/ M program file name and files ( Trends99_ im. xls), OBD Schedules ( Model. wpd), other future programs ( Counties. wpd). Source of " cutpoint" file references in the I/ M files. Source for ATP Info.

Vehicle Tables Folder AverageSpeed vmt99_ f_ m6_ with_ 8Sta tesUpdate. DBF Modeling files for June 2002 update to the 1999 NEI, extracted from the VMT table.

BaseYearVMT vmt99_ f_ m6_ with_ 8Sta tesUpdate. DBF vmt99_ n_ m6. dbf Modeling files for June 2002 update to the 1999 NEI for the 50 state and Washington, DC, and Fall 2001 update to the 1999 NEI for Puerto Rico and the Virgin Islands.

VMTGrowth BaseYearVMT table V 2. xls V 3. xls V 4. xls VMT estimates for calendar year 2007, calendar year 2020, and calendar year 2030 provided by the EPA from appendix tables in the support documentation for the 2007 Heavy Duty Diesel Rule ( HD2007).

VMTMonthAllocation 1999 NEI document " Onroad Source Methodologies" dated 10/ 2001 Additional Tables Folder County EPA_ CHIEF_ county_ fips. xls The spreadsheet was retrieved from http:// www. epa. gov/ ttn/ chief/ codes/ index. html.

CountyMonth mxmntp99. dbf pr_ vi_ temps. xls Fall 2001 update to the 1999 NEI.

State trends99_ pointer. dbf June 2002 update to the 1999 NEI, and Fall 2001 update to the 1999 NEI. See 1999 Updated M6 Input Files\*.* under CountyYear for source for NLEV file references.

DB Documentation Folder Not applicable CountyDB. pdf CountyDB. rtf County database documentation SQLScripts Folder NMIM Table Name File Name Description A 3 All NMIM Tables Load_ Data_ Tables. sql Load_ Data_ BaseYearV MT. sql Load_ Data_ VMTGrowt h. sql QA_ Script_ 1. sql QA_ Script_ 2. sql QA_ Script_ 3. sql Data Loading Scripts Quality Assurance Scripts Data Files Folder Vehicle tables GenerateVMTMoAlloc. awk Code to Produce VMT Data County Rep_ County_ Mapping. s ql Representative County Mapping Code