[Federal Register Volume 80, Number 201 (Monday, October 19, 2015)]
[Proposed Rules]
[Pages 63153-63155]
[FR Doc No: 2015-26499]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 73

[Docket No. FAA-2015-3680; Airspace Docket No. 13-ASW-15]
RIN 2120-AA66

Proposed Establishment of and Modification to Restricted Areas;
Fort Sill, OK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to establish 2 new restricted areas (R-
5601G and R-5601H) to expand the special use airspace (SUA) complex
located at Fort Sill, OK, to provide additional maneuvering airspace
for current and planned training activities determined to be hazardous
to non-participating aircraft. Specifically, the proposed restricted
areas would provide participating fighter or bomber aircraft with
laser-firing and maneuvering airspace when training at the Falcon
Bombing Range contained in R-5601C, at the West Range Target Area
contained in R-5601B, or at the East Range Target Area contained in R-
5601A. In addition, the using agency for all Fort Sill restricted areas
would be updated to reflect the current organization tasked with that
responsibility. The U.S. Army requested that the FAA take this action
to allow realistic training on current tactics developed and refined
during recent combat operations for employing hazardous targeting laser
systems and weapons capabilities at longer ranges from the target area.

DATES: Comments must be received on or before December 3, 2015.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, M-30, 1200 New Jersey Avenue SE.,
West Building Ground Floor, Room W12-140, Washington, DC 20590-0001;
telephone:<PHONE_NUMBER>. You must identify FAA Docket No. FAA-2015-
3680 and Airspace Docket No. 13-ASW-15, at the beginning of your
comments. You may also submit comments through the Internet at http://www.regulations.gov. Comments on environmental and land use aspects to
should be directed to: Mr. Glen Wheat, U.S. Army Garrison, Directorate
of Public Works, IMWE-SIL-PWE, 5503 NW. Currie Road, Fort Sill, OK
73503-9051; email<EMAIL_ADDRESS>and telephone: (580) 442-
2715.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, Airspace Policy Group,
Office of Airspace Services, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of the
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would restructure the restricted airspace at Fort Sill, OK, to
enhance safety and accommodate essential military training.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2015-3680 and Airspace Docket No. 13-ASW-15) and be submitted in
triplicate to the Docket Management System (see ADDRESSES section for
address and phone number). You may also submit comments through the
internet at http://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to FAA Docket No. FAA-2015-3680 and Airspace Docket No. 13-ASW-15.''
The postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified closing date
for comments will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the closing date
for comments. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRM's

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person at the Dockets
Office (see ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
holidays. An informal docket may also be examined during normal
business hours at the office of the Operations Support Group, Central
Service Center, Federal Aviation Administration, 2601 Meacham Blvd.,
Fort Worth, TX 76137.
    Persons interested in being placed on a mailing list for future
NPRMs should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>,
for a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

Background

    Military use of the airspace at Fort Sill, OK, can be traced back
to 1949. Today, the Fort Sill SUA complex consists of six restricted
areas, designated R-5601A, R-5601B, R-5601C, R-5601D, R-5601E, and R-
5601F. The three ranges (Falcon Range, West Range, and East Range)
contained within the Fort Sill SUA complex are used for a wide variety
of military air and ground activities; including, but not limited to,
air-to-surface weapons delivery training, laser systems, artillery, and
joint air and ground forces exercises. Weapons events include high-,
medium-, and low-altitude bombing runs, to include level, climbing, and
diving deliveries. Today, real-world combat tactics for employing
targeting lasers and weapons systems at distances farther from the
target are driving the requirement for increased lateral dimensions of
the Fort Sill SUA complex to support aircrew training in laser
employment and weapons delivery tactics. Although the R-5601A, R-5601B,
R-5601C, and R-5601F airspace areas extend to a maximum altitude of
40,000 feet mean sea level (MSL), the relatively small north to south
dimensions of the restricted areas (approximately 9 nautical miles (NM)
at its widest point) is not sufficient to provide the required distance
from targets needed by aircrews employing current combat laser
targeting or weapons deliveries tactics. Since there is no alternative
SUA complex within 200 NM where combat lasers may be employed, aircrew
training is significantly restricted at the Fort Sill ranges.

The Proposal

    The FAA is proposing an amendment to 14 CFR part 73 to establish 2
new restricted areas (designated R-5601G and R-5601H) at Fort Sill, OK.
This action would establish restricted area R-5601G with a ceiling to,
but not including, 8,000 feet MSL under the Washita Military Operations
Area (MOA), and establish restricted area R-5601H with a ceiling of
Flight Level (FL) 400 to match the adjacent restricted areas; thus,
expanding the lateral limits of restricted area airspace at the Fort
Sill SUA complex. Restricted area R-5601G would abut the existing
restricted area complex to the north, underlying the Washita MOA, and
extend from 500 feet above ground level (AGL) to, but not including,
8,000 feet MSL. R-5601G would extend approximately three quarters of
the existing restricted area complex northward, between 5 NM to 11 NM,
to provide the required expanded lateral space from the current range
boundaries. Restricted area R-5601H would extend from the surface to
FL400. R-5601H would fill a small airspace area surrounded by two
continuously active restricted areas (R-5601A and R-5601B) extending
from the surface to FL400 and a MOA extending from 8,000 feet MSL to,
but not including, FL180. Additionally, when active, R-5601H would
overlay the Fort Sill post and a portion of the Class D airspace
supporting the non-joint use military airfield located at Fort Sill.
    The two new restricted areas would allow participating aircraft to
maneuver within the current Fort Sill Approach Control Airspace and
contain the hazardous combat laser energy (not eye-safe) within
restricted airspace. As proposed, R-5601G would only be used for
aircraft maneuvering and combat laser targeting employment and R-5601H
would only be used for aircraft conducting Close Air Support (CAS)
training. There would be no changes to

the existing pattern of firing, ordnance delivery runs, or weapons
impact areas and all weapons release would continue to occur in R-
5601A, R-5601B, or R-5601C, as they are now. Additionally, no
supersonic flight will occur.
    In addition to the proposed establishment of R-5601G and R-5601H,
the following minor changes to the descriptions of the six existing
Fort Sill restricted areas would be made. The using agency for R-5601A-
E would be changed from ``U.S. Army, Commanding General, Fort Sill,
OK,'' to ``U.S. Army, Commanding General, U.S. Army Fires Center of
Excellence (USAFCOE), Fort Sill, OK.'' The using agency for R-5601F
would be changed from ``Commanding General, United States Army Field
Artillery Center (USAFACFS), Fort Sill, OK,'' to ``U.S. Army,
Commanding General, U.S. Army Fires Center of Excellence (USAFCOE),
Fort Sill, OK.'' This change would reflect the current organizational
responsibilities. The new using agency would also apply to the proposed
R-5601G and R-5601H. The boundaries, designated altitudes, times of
designation, and controlling agency information for restricted areas R-
5601A-F would not be changed by this proposal.
    The FAA does not anticipate any aeronautical impacts as a result of
this proposed action since Fort Sill Approach Control has radar
coverage over the proposed restricted areas and already controls the
airspace from surface to 7,000 feet MSL. Procedures will be established
to continue allowing non-participating aircraft access to the airspace
even when the restricted areas are in use. Pilots seeking information
about the activity status of R-5601G and R-5601H should contact Fort
Sill Approach Control on the frequency listed in the ``Special Use
Airspace'' panel of the Dallas--Ft. Worth Sectional Aeronautical Chart.
Fort Sill Approach Control will continue to provide VFR traffic
advisories, as they do today, to non-participating aircraft requesting
them.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under
Department of Transportation (DOT) Regulatory Policies and Procedures
(44 FR 11034; February 26, 1979); and (3) does not warrant preparation
of a regulatory evaluation as the anticipated impact is so minimal.
    Since this is a routine matter that will only affect air traffic
procedures and air navigation, it is certified that this proposed rule,
when promulgated, will not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.

Environmental Review

    This proposal will be subjected to an environmental analysis in
accordance with FAA Order 1050.1E, ``Environmental Impacts: Policies
and Procedures,'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 73

    Airspace, Prohibited areas, Restricted areas.

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 73 as follows:

PART 73--SPECIAL USE AIRSPACE

0
1. The authority citation for part 73 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  73.56  (Amended)

0
2. Sec.  73.56 is amended as follows:

R-5601A Fort Sill, OK [Amended]

    By removing the current using agency and substituting the
following:
    Using agency. U.S. Army, Commanding General, U.S. Army Fires
Center of Excellence (USAFCOE), Fort Sill, OK.

R-5601B Fort Sill, OK [Amended]

    By removing the current using agency and substituting the
following:
    Using agency. U.S. Army, Commanding General, U.S. Army Fires
Center of Excellence (USAFCOE), Fort Sill, OK.

R-5601C Fort Sill, OK [Amended]

    By removing the current using agency and substituting the
following:
    Using agency. U.S. Army, Commanding General, U.S. Army Fires
Center of Excellence (USAFCOE), Fort Sill, OK.

R-5601D Fort Sill, OK [Amended]

    By removing the current using agency and substituting the
following:
    Using agency. U.S. Army, Commanding General, U.S. Army Fires
Center of Excellence (USAFCOE), Fort Sill, OK.

R-5601E Fort Sill, OK [Amended]

    By removing the current using agency and substituting the
following:
    Using agency. U.S. Army, Commanding General, U.S. Army Fires
Center of Excellence (USAFCOE), Fort Sill, OK.

R-5601F Fort Sill, OK [Amended]

    By removing the current using agency and substituting the
following:
    Using agency. U.S. Army, Commanding General, U.S. Army Fires
Center of Excellence (USAFCOE), Fort Sill, OK.

R-5601G Fort Sill, OK [New]

    Boundaries. Beginning at Lat. 34[deg]46'07'' N., long.
98[deg]25'50'' W.; to Lat. 34[deg]45'03'' N., long. 98[deg]29'46''
W.; thence counterclockwise via the 46 NM arc of SPS VORTAC to Lat.
34[deg]43'46'' N., long. 98[deg]49'55'' W.; to Lat. 34[deg]47'00''
N., long. 98[deg]51'00'' W.; to Lat. 34[deg]50'30'' N., long.
98[deg]46'02'' W.; to Lat. 34[deg]57'51'' N., long. 98[deg]25'47''
W.; to the point of beginning.
    Designated altitudes. 500 feet AGL to, but not including, 8,000
feet MSL.
    Time of designation. Sunrise to 2200 local time, Monday-Friday;
other times by NOTAM.
    Controlling agency. FAA, Fort Worth ARTCC.
    Using agency. U.S. Army, Commanding General, U.S. Army Fires
Center of Excellence (USAFCOE), Fort Sill, OK.

R-5601H Fort Sill, OK [New]

    Boundaries. Beginning at Lat. 34[deg]38'15'' N., long.
98[deg]20'56'' W.; to Lat. 34[deg]38'30'' N., long. 98[deg]21'41''
W.; to Lat. 34[deg]38'50'' N., long. 98[deg]22'06'' W.; to Lat.
34[deg]39'53'' N., long. 98[deg]22'16'' W.; to Lat. 34[deg]40'47''
N., long. 98[deg]23'09'' W.; thence counterclockwise along an arc,
3-mile radius centered at Lat. 34[deg]38'18'' N., long.
98[deg]24'07'' W.; to Lat. 34[deg]40'12'' N., long. 98[deg]26'18''
W.; to Lat. 34[deg]38'15'' N., long. 98[deg]26'19'' W.; to the point
of beginning.
    Designated altitudes. Surface to FL 400.
    Time of designation. By NOTAM.
    Controlling agency. FAA, Fort Worth Center.
    Using agency. U.S. Army, Commanding General, U.S. Army Fires
Center of Excellence (USAFCOE), Fort Sill, OK.

    Issued in Washington, DC on October 8, 2015.
Gary A. Norek,
Manager, Airspace Policy Group.
[FR Doc. 2015-26499 Filed 10-16-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 248 (Thursday, December 28, 2017)]
[Rules and Regulations]
[Pages 61443-61446]
[FR Doc No: 2017-27973]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16 and 511

[Docket No. FDA-2011-N-0079]
RIN 0910-AH64

New Animal Drugs for Investigational Use; Disqualification of a
Clinical Investigator

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
issuing a final rule amending 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. Under this final rule, 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 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 final rule will help ensure adequate
protection of animal research subjects and the quality and integrity of
data submitted to FDA.

DATES: This rule is effective January 29, 2018.

ADDRESSES: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number found in brackets in the heading of this final rule into
the ``Search'' box and follow the prompts,

and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Vernon Toelle, Center for Veterinary
Medicine (HFV-230), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Final Rule
    B. Summary of the Major Provisions of the Final Rule
    C. Legal Authority
    D. Costs and Benefits
II. Background
    A. Need for the Regulation
    B. Summary of Comments to the Proposed Rule
III. Legal Authority
IV. Comments on the Proposed Rule and FDA Response
V. Effective Date
VI. Economic Analysis of Impacts
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Federalism

I. Executive Summary

A. Purpose of the Final Rule

    The regulations in Sec.  511.1(c) (21 CFR 511.1(c)) provide 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. However, the animal
drug regulations permit the same clinical investigator to conduct both
nonclinical laboratory studies as well as clinical investigations. We
have proposed changes to these regulations (81 FR 57812, August 24,
2016) that would prevent disqualified clinical investigators from
conducting nonclinical laboratory studies intended to support an
application for a research or marketing permit for a new animal drug,
thus enhancing protection of animal research subjects and ensuring the
quality and integrity of data submitted to FDA in support of a new
animal drug approval.

B. Summary of the Major Provisions of the Final Rule

    This final rule expands the clinical investigator disqualification
regulations in Sec.  511.1(c) to include the ineligibility of a
disqualified investigator to conduct any nonclinical laboratory study
intended to support an application for a research or marketing permit
for a new animal drug. We received one comment, and it supported the
proposed amendment.

C. Legal Authority

    FDA is issuing these regulations based on its authority under the
new animal drug provisions in section 512 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 360b) and under section 701(a)
of the FD&C Act (21 U.S.C. 371(a)), which gives the Agency general
rulemaking authority to issue regulations for the efficient enforcement
of the FD&C Act.

D. Costs and Benefits

    FDA believes this final rule is not a significant regulatory action
as defined by Executive Order 12866 and certifies that it will not have
a significant economic impact on a substantial number of small
entities. FDA and applicants will not incur additional costs by
expanding the scope in part 511 for disqualification of a clinical
investigator. The benefit of preventing a disqualified clinical
investigator from performing both nonclinical laboratory studies as
well as clinical investigations will be enhanced protection of animal
research subjects and data integrity submitted to FDA in support of a
new animal drug approval.

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 or the Center) 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 (21 CFR
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, 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 clinical investigations and nonclinical laboratory
studies 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 clinical investigations and nonclinical
laboratory studies. 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 who 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, CVM
proposed (81 FR 57812) that it have authority to disqualify an
investigator from conducting nonclinical laboratory studies intended to
support an application for a research or marketing permit for a new
animal drug when that same investigator is disqualified from conducting
clinical investigations.

A. Need for the Regulation

    Expanding the regulations to include that a disqualified
investigator is ineligible to conduct any nonclinical laboratory study
intended to support an application for a research or marketing permit
for a new animal drug helps to ensure adequate protection of animal
research subjects and data integrity. This action also leads to
improved public confidence in the nonclinical and clinical data
supporting FDA decisions for new animal drug approvals.

B. Summary of Comments to the Proposed Rule

    We received one comment to the proposed rule. The comment supports
the proposal. Therefore, we are finalizing the proposal without
revision.

III. Legal Authority

    We are issuing this final rule under section 512(j) of the FD&C
Act, which 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, and section 701(a) of the FD&C Act, which authorizes FDA
to issue regulations for the efficient enforcement of the FD&C Act. An
investigator 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. FDA therefore concludes that
legal authority to promulgate this rule 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).

IV. Comments on the Proposed Rule and FDA Response

    We received no adverse or substantive comment and are finalizing
without change.

V. Effective Date

    This rule is effective January 29, 2018.

VI. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, Executive Order 13771, 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 us 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). Executive Order 13771
requires that the costs associated with significant new regulations
``shall, to the extent permitted by law, be offset by the elimination
of existing costs associated with at least two prior regulations.''
This final rule is not a significant regulatory action as defined by
Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because this rule does not impose new requirements on any
entity and therefore has no associated compliance costs, we certify
that the final rule will not have a significant economic impact on a
substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``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 $148
million, using the most current (2016) Implicit Price Deflator for the
Gross Domestic Product. This final rule will not result in an
expenditure in any year that meets or exceeds this amount.
    This rule expands the scope in part 511 of disqualification of a
clinical investigator to include ineligibility to conduct nonclinical
laboratory studies intended to support an application for a research or
marketing permit for a new animal drug. A final rule published on April
30, 2012 (77 FR 25353), prevents a disqualified investigator from
conducting any clinical investigation, and therefore applies explicitly
to clinical investigations. However, that rule was silent on
nonclinical laboratory studies. Thus, before this final rule, 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 for disqualification in part
511 is typically the repeated or deliberate submission of false
information to us or to sponsors 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.
    We will not incur additional costs by expanding the scope in part
511 for disqualification of a clinical investigator because we already
post the names of any disqualified investigator on FDA's internet site
at https://www.accessdata.fda.gov/scripts/SDA/sdNavigation.cfm?sd=clinicalinvestigatorsdisqualificationproceedings&previewMode=true&displayAll=true. Similarly, industry will not incur
additional costs because the rule does not require applicants to
perform additional tasks. For instance, upon disqualification, we post
the respective investigator's name on FDA's internet site, which helps
mitigate the employment of a disqualified investigator for clinical
investigations or nonclinical laboratory studies intended to support an
application for a research or marketing permit for a new animal drug.
The benefit of preventing a disqualified clinical investigator from
performing both nonclinical laboratory studies and clinical
investigations will be enhanced protection of animal research subjects
and data integrity.

VII. Analysis of 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.

VIII. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.

IX. Federalism

    We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that 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, we conclude that the 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, 21 CFR parts
16 and 511 are 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) * * *
    (c)(1), relating to whether an investigator is eligible to receive
test articles under part 511 of this chapter and eligible 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; and
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:
0
a. Revise the section heading;
0
b. Revise the last sentence in paragraph (c)(1);
0
c. Add paragraphs (c)(1)(i) and (ii);
0
d. Revise the last sentence in paragraph (c)(2);
0
e. Add paragraphs (c)(2)(i) and (ii); and
0
f. Revise paragraph (c)(6).
    The revisions and additions 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 test articles 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: December 21, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27973 Filed 12-27-17; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 121 (Friday, June 24, 2022)]
[Notices]
[Pages 37845-37846]
[FR Doc No: 2022-13465]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 15094-001]

Ohio Power and Light, LLC; Notice of Intent To File License
Application, Filing of Pre-Application Document, and Approving Use of
the Traditional Licensing Process

    a. Type of Application: Notice of Intent (NOI) to File License
Application and Request to Use the Traditional Licensing Process (TLP).
    b. Project No.: 15094-001.
    c. Date filed: April 22, 2022.
    d. Submitted by: Ohio Power and Light, LLC (Ohio Power and Light).
    e. Name of Project: Robert C. Byrd Hydroelectric Project.
    f. Location: The project would be located on the Ohio River, at the
existing U.S. Army Corps of Engineers' (Corps) Robert C. Byrd Locks and
Dam, near the Town of Gallipolis, in Gallia County, Ohio and the Town
of Gallipolis Ferry, Mason County, West Virginia. The project would
occupy 5 acres of federal land administered by the Corps.
    g. Filed Pursuant to: 18 CFR 5.3 of the Commission's regulations.
    h. Potential Applicant Contact: Mr. Roy Powers, Chief Operations
Officer, Current Hydro, LLC, Post Office Box 224, Rhinebeck, NY 12572.
Phone:<PHONE_NUMBER>, Email: [email protected].
    i. FERC Contact: Andy Bernick, Phone:<PHONE_NUMBER>, Email:
[email protected].
    j. Ohio Power and Light filed its request to use the TLP on April
22, 2022 and provided public notice of its request on April 30, 2022.
In a letter dated June 16, 2022, the Director of the Division of
Hydropower Licensing approved Ohio Power and Light's request to use the
TLP.
    k. With this notice, we are initiating informal consultation with
the U.S. Fish and Wildlife Service and/or NOAA Fisheries under section
7 of the Endangered Species Act and the joint agency regulations
thereunder at 50 CFR, Part 402; and NOAA Fisheries under section 305(b)
of the Magnuson-Stevens Fishery Conservation and Management Act and
implementing regulations at 50 CFR 600.920. We are also initiating
consultation with the West Virginia Historic Preservation Officer, as
required by section 106, National Historic Preservation Act, and the
implementing regulations of the Advisory Council on Historic
Preservation at 36 CFR 800.2.

    l. With this notice, we are designating Ohio Power and Light as the
Commission's non-federal representative for carrying out informal
consultation pursuant to section 7 of the Endangered Species Act; and
consultation pursuant to section 106 of the National Historic
Preservation Act.
    m. Ohio Power and Light filed a Pre-Application Document (PAD;
including a proposed process plan and schedule) with the Commission,
pursuant to 18 CFR 5.6 of the Commission's regulations.
    n. A copy of the PAD may be viewed on the Commission's website
(https://www.ferc.gov), using the ``eLibrary'' link. Enter the docket
number, excluding the last three digits in the docket number field, to
access the document. For assistance, contact FERC Online Support at
[email protected],<PHONE_NUMBER> (toll free), or (202) 502-
8659 (TTY).
    o. The applicant states its unequivocal intent to submit an
application for an original license for Project No. 15094.
    p. Register online at https://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filing and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.

    Dated: June 16, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-13465 Filed 6-23-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 157 (Monday, August 15, 2011)]
[Rules and Regulations]
[Pages 50405-50407]
[FR Doc No: 2011-20165]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-0530 Directorate Identifier 2011-CE-012-AD;
Amendment 39-16770; AD 2011-17-06]
RIN 2120-AA64

Airworthiness Directives; SOCATA Airplanes

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

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for SOCATA
Model TBM 700 airplanes. This AD results from mandatory continuing
airworthiness information (MCAI) issued by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    A TBM 700 operator reported a case of elevator trim tab actuator
jamming once the trim tab arrived to stop.
    The investigations conducted by the trim tab actuator
manufacturer have shown that there was a discrepancy with PRECILEC
manufacturing process of elevator trim tab actuator which caused
this event. It has been determined as well that this discrepancy is
limited to a batch of Serial Numbers (S/N).
    If not detected and corrected, a jammed trim tab could lead to
unusual control forces, resulting in lower controllability,
particularly if combined with adverse flight conditions at landing.

We are issuing this AD to require actions to correct the unsafe
condition on these products.

DATES: This AD becomes effective September 19, 2011.
    On September 19, 2011, the Director of the Federal Register
approved the incorporation by reference of certain publications listed
in this AD.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov or in person at Document Management Facility, U.S.
Department of Transportation, Docket Operations, M-30, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC
20590.
    For service information identified in this AD, contact SOCATA--
Direction des Services--65921 Tarbes Cedex 9--France; telephone +33 (0)
62 41 7300, fax +33 (0) 62 41 76 54, or for North America: SOCATA NORTH
AMERICA, 7501 South Airport Road, North Perry Airport (HWO), Pembroke
Pines, Florida 33023; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
e-mail<EMAIL_ADDRESS>Internet: http://mysocata.com. You
may review copies of the referenced service information at the FAA,
Small Airplane Directorate, 901 Locust, Kansas City, Missouri 64106.
For information on the availability of this material at the FAA, call
(816) 329-4148.

FOR FURTHER INFORMATION CONTACT: Albert Mercado, Aerospace Engineer,
FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on May 25, 2011 (76 FR
30295). That NPRM proposed to correct an unsafe condition for the
specified products. The MCAI states:

    A TBM 700 operator reported a case of elevator trim tab actuator
jamming once the trim tab arrived to stop.
    The investigations conducted by the trim tab actuator
manufacturer have shown that there was a discrepancy with PRECILEC
manufacturing process of elevator trim tab actuator which caused
this event. It has been determined as well that this discrepancy is
limited to a batch of Serial Numbers (S/N).
    If not detected and corrected, a jammed trim tab could lead to
unusual control forces, resulting in lower controllability,
particularly if combined with adverse flight conditions at landing.
    For the reasons described above, this AD requires the inspection
of the elevators trim tab actuator P/N<PHONE_NUMBER> for identification
of S/N and, in case of findings, the replacement of the affected
ones with serviceable units.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM or on the determination of
the cost to the public.

Conclusion

    We reviewed the available data and determined that air safety and
the public interest require adopting the AD as proposed.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a NOTE within the AD.

Costs of Compliance

    We estimate that this AD will affect 377 products of U.S. registry.
We also estimate that it would take about 1 work-hour per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour. Required parts would cost about $0 per product.
    Based on these figures, we estimate the cost of the AD on U.S.
operators to be $32,045, or $85 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 7 work-hours and require parts costing $0, for a cost of
$595 per product. We have no way of determining the number of products
that may need these actions.
    According to the manufacturer, some of the costs of this AD may be
covered under warranty, thereby reducing the cost impact on affected
individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

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 determined that 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 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); 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 AD and placed it in the AD Docket.

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 the NPRM, 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.

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 AD:

2011-17-06 SOCATA: Amendment 39-16770; Docket No. FAA-2011-0530;
Directorate Identifier 2011-CE-012-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective
September 19, 2011.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to SOCATA Model TBM 700 airplanes, serial
numbers 1 through 530, certificated in any category.

Subject

    (d) Air Transport Association of America (ATA) Code 27: Flight
Controls.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    A TBM 700 operator reported a case of elevator trim tab actuator
jamming once the trim tab arrived to stop.
    The investigations conducted by the trim tab actuator
manufacturer have shown that there was a discrepancy with PRECILEC
manufacturing process of elevator trim tab actuator which caused
this event. It has been determined as well that this discrepancy is
limited to a batch of Serial Numbers (S/N).
    If not detected and corrected, a jammed trim tab could lead to
unusual control forces, resulting in lower controllability,
particularly if combined with adverse flight conditions at landing.
    For the reasons described above, this AD requires the inspection
of the elevators trim tab actuator P/N<PHONE_NUMBER> for identification
of S/N and, in case of findings, the replacement of the affected
ones with serviceable units.

Actions and Compliance

    (f) Unless already done, do the following actions:
    (1) Within 12 months after September 19, 2011 (the effective
date of this AD), identify the serial number (S/N) of Left Hand and
Right Hand PRECILEC elevator trim tab actuators following DAHER-
SOCATA Mandatory Service Bulletin SB 70-190-27, dated January 2011.
    (2) If, as a result of the inspection required by paragraph
(f)(1) of this AD you find any affected elevator trim tab actuator
as listed in DAHER-SOCATA Mandatory Service Bulletin SB 70-190-27,
dated January 2011, installed on an airplane, before further flight,
replace it with a serviceable part following DAHER-SOCATA Mandatory
Service Bulletin SB 70-190-27, dated January 2011.
    (3) After September 19, 2011 (the effective date of this AD), do
not install on an airplane any PRECILEC elevator trim tab actuator
part number<PHONE_NUMBER> with an S/N listed in DAHER-SOCATA Mandatory
Service Bulletin SB 70-190-27, dated January 2011, unless it has
been repaired in accordance with DAHER-SOCATA Mandatory Service
Bulletin SB 70-190-27, dated January 2011.

    Note 1: Trim tab actuators repaired by a service center are
identified with screw green colored locking varnish as shown in
figure 2 of DAHER-SOCATA Mandatory Service Bulletin SB 70-190-27,
dated January 2011.

FAA AD Differences

    Note 2: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Albert Mercado, Aerospace Engineer, FAA, Small
Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; e-mail:
<EMAIL_ADDRESS>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.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, a federal agency may not conduct or sponsor, and a person
is not required to respond to, nor shall a person be subject to a
penalty for failure to comply with a collection of information
subject to the requirements of the Paperwork Reduction Act unless
that collection of information displays a current valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public reporting for this collection of information is
estimated to be approximately 5 minutes per response, including the
time for reviewing instructions, completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Comments concerning the accuracy of this
burden and suggestions for reducing the burden should be directed to
the FAA at: 800 Independence Ave., SW., Washington, DC 20591, Attn:
Information Collection Clearance Officer, AES-200.

Related Information

    (h) Refer to MCAI European Aviation Safety Agency (EASA) AD No.:
2011-0060, dated March 29, 2011 (Correction: March 30, 2011); and
DAHER-SOCATA Mandatory Service Bulletin SB 70-190-27, dated January
2011, for related information.

Material Incorporated by Reference

    (i) You must use DAHER-SOCATA Mandatory Service Bulletin SB 70-
190-27,

dated January 2011, to do the actions required by this AD, unless
the AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
SOCATA--Direction des Services--65921 Tarbes Cedex 9--France;
telephone +33 (0) 62 41 7300, fax +33 (0) 62 41 76 54, or for North
America: SOCATA NORTH AMERICA, 7501 South Airport Road, North Perry
Airport (HWO), Pembroke Pines, Florida 33023; telephone: (954) 893-
1400; fax:<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
Internet: http://mysocata.com.
    (3) You may review copies of the referenced service information
at the FAA, Small Airplane Directorate, 901 Locust, Kansas City,
Missouri 64106. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>.
    (4) You may also review copies of the service information
incorporated by reference for this AD at the National Archives and
Records Administration (NARA). For information on the availability
of this material at NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

    Issued in Kansas City, Missouri, on July 28, 2011.
Steven W. Thompson,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2011-20165 Filed 8-12-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 186 (Wednesday, September 29, 2021)]
[Notices]
[Pages 54005-54006]
[FR Doc No: 2021-21187]

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

SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 34381; 812-15250]

The Optima Dynamic Alternatives Fund, et al;

September 24, 2021.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION:  Notice.

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

    Notice of an application under section 6(c) of the Investment
Company Act of 1940 (the ``Act'') for an exemption from sections
18(a)(2), 18(c) and 18(i) of the Act and for an order pursuant to
section 17(d) of the Act and rule 17d-1 under the Act.
    Summary of Application: Applicants request an order to permit
certain registered closed end investment companies to issue multiple
classes of shares of beneficial interest with varying sales loads and
to impose asset-based distribution and/or service fees.
    Applicants: The Optima Dynamic Alternatives Fund (the ``Initial
Fund''), and Optima Asset Management LLC (the ``Adviser'').
    Filing Dates: The application was filed on July 23, 2021 and
amended on September 7, 2021.
    Hearing or Notification of Hearing: An order granting the requested
relief will be issued unless the Commission orders a hearing.
Interested persons may request a hearing on any application by emailing
the SEC's Secretary at<EMAIL_ADDRESS>and serving the
relevant applicant with a copy of the request by email, if an email
address is listed for the relevant applicant below, or personally or by
mail, if a physical address is listed for the relevant applicant below.
    Hearing requests should be received by the Commission by 5:30 p.m.
on October 19, 2021, and should be accompanied by proof of service on
applicants, in the form of an affidavit or, for lawyers, a certificate
of service. Pursuant to rule 0-5 under the Act, hearing requests should
state the nature of the writer's interest, any facts bearing upon the
desirability of a hearing on the matter, the reason for the request,
and the issues contested. Persons who wish to be notified of a hearing
may request notification by emailing the Commission's Secretary.

ADDRESSES<EMAIL_ADDRESS>and
<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT:  Lisa Reid Ragen, Branch Chief, at
(202) 551-6825 (Division of Investment Management, Chief Counsel's
Office).

SUPPLEMENTARY INFORMATION:  For Applicants' representations, legal
analysis, and condition, please refer to Applicants' application, dated
September 7, 2021, which may be obtained via the Commission's website
by searching for the file number, using the Company name box, at http://www.sec.gov/search/search.htm, or by calling<PHONE_NUMBER>.

    For the Commission, by the Division of Investment Management,
under delegated authority.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-21187 Filed 9-28-21; 8:45 am]
BILLING CODE 8011-01-P


Reader’s Guide to the Dikegulac Sodium RED and Supporting Documents:

Docket # EPA-HQ-OPP-2006-0954

	EPA has created this document to provide an organizational structure to
the dikegulac sodium docket.  The docket index lists the dikegulac
sodium items sequentially, while this document lists them by subject
matter.  The Agency is providing the “Reader’s Guide” to allow the
reader to more easily access and navigate the various items contained in
the dikegulac sodium docket.

Federal Register and Docket Organizational Documents:

Federal Register Notice: <Dikegulac Sodium Reregistration Eligibility
Decision; Notice of Availability>

Miscellaneous Documents

Reader’s Guide to the Dikegulac Sodium RED and Supporting Documents:

Docket # EPA-HQ-OPP-2006-0954

Permethrin Reregistration Eligibility Decision

Reregistration Eligibility Decision (RED) for Dikegulac Sodium

Technical Support Documents

Health Effects Documents

Dikegulac Sodium. Human Health Consideration for the Reregistration
Eligibility Decision.  October 31, 2006.

Dikegulac Sodium.  Addendum to the HED Risk Assessment.  February 6,
2007.

Ecological Fate and Effects Documents

EFED Risk Assessment for the Reregistration of Dikegulac Sodium.
October 6, 2006.

Drinking Water Assessment for Dikegulac-Sodium Reregistration
Eligibility Decision (RED).  February 9, 2007.


[Federal Register Volume 84, Number 74 (Wednesday, April 17, 2019)]
[Notices]
[Pages 16130-16132]
[FR Doc No: 2019-07618]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85624; File No. SR-C2-2019-008]

Self-Regulatory Organizations; Cboe C2 Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Extend
the Pilot for Certain Options Market Rules That Are Linked to the
Equity Market Plan To Address Extraordinary Market Volatility

April 11, 2019.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on April 9, 2019, Cboe C2 Exchange, Inc. (``Exchange'' or ``C2'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Cboe C2 Exchange, Inc. (``C2'' or the ``Exchange'') is filing with
the Securities and Exchange Commission (the ``Commission'') a proposed
rule change to extend the pilot to the close of business on October 18,
2019, for certain options market rules that are linked to the equity
market Plan to Address Extraordinary Market Volatility. The text of the
proposed rule change is attached as Exhibit 5 [sic].
    The text of the proposed rule change is also available on the
Exchange's website (http://markets.cboe.com/us/options/regulation/rule_filings/ctwo/), at the Exchange's Office of the Secretary, and at
the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of the proposed rule change is to extend the pilot to
the close of business on October 18, 2019, for certain options market
rules that are linked to the equity market Plan to Address
Extraordinary Market Volatility (the ``Limit Up-Limit Down Plan'' or
the ``Plan''). This change is being proposed in connection with a
proposed amendment to the Limit Up-Limit Down Plan that would allow the
Plan to continue to operate on a permanent basis (``Amendment 18'').
    In an attempt to address extraordinary market volatility in NMS
Stock, and, in particular, events like the severe volatility on May 6,
2010, U.S. national securities exchanges and the Financial Industry
Regulatory Authority, Inc. (collectively, ``Participants'') drafted the
Plan pursuant to Rule 608 of Regulation NMS and under the Act.\3\ On
May 31, 2012, the Commission approved the Plan, as amended, on a one-
year pilot basis.\4\ Though the Plan was primarily designed for equity
markets, the Exchange believed it would, indirectly, potentially impact
the options markets as well. Thus, the Exchange has previously amended
and adopted Interpretation and Policy .01 to Rule 6.29, Interpretation
and Policy .01 to Rule 6.32 and Rule 6.39 to ensure the option markets
were not harmed as a result of the Plan's implementation and has
implemented such rules on a pilot basis that has coincided with the
pilot period for the Plan (the ``Options Pilots'').\5\
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 64547 (May 25,
2011), 76 FR 31647 (June 1, 2011) (File No. 4-631).
    \4\ See Securities and Exchange Act Release No. 67091 (May 31,
2012) 77 FR 33498 (June 6, 2012).
    \5\ See Securities Exchange Act Release Nos. 69345 (April 8,
2013), 78 FR 21985 (April 12, 2013) (SR-C2-2013-013) (amending
certain options rules to coincide with the pilot period for the
Plan, including Rule 6.39 and Interpretation and Policy .08 to Rule
6.15, which was later renumbered to Interpretation and Policy .01 to
Rule 6.29); and 68769 (January 30, 2013), 78 FR 8213 (February 5,
2013) (amending Interpretation and Policy .03 to Rule 6.32, which
was later renumbered to Interpretation and Policy .01, to coincide
with the pilot period for the Plan).

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

    The Commission recently published an Amendment 18, which would
allow the Plan to operate on a permanent, rather than pilot, basis.\6\
In connection with this change, the Exchange proposes to amend the
Options Pilots to expire at the close of business on October 18, 2019--
i.e., six months after the expiration of the current pilot period for
the Plan. Specifically, the Exchange proposes to amend Interpretation
and Policy .01 to Rule 6.29, Interpretation and Policy .01 to Rule 6.32
and Rule 6.39 to untie the Options Pilot's effectiveness from that of
the Plan and to extend the Options Pilot's effectiveness to the close
of business on October 18, 2019. The Exchange understands that the
other national securities exchanges will also file similar proposals to
extend their respective pilot programs.
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release Nos. 84843 (December 18,
2018), 83 FR 66464 (December 26, 2018) (Amendment No. 18 Proposing
Release).
---------------------------------------------------------------------------

    The Exchange does not propose any additional changes to
Interpretation and Policy .01 to Rule 6.29, Interpretation and Policy
.01 to Rule 6.32 and Rule 6.39. The Exchange believes the benefits to
market participants from the Options Pilots should continue on a
limited six month pilot basis after Commission approves the Plan to
operate on a permanent basis. Assuming the Plan is approved by the
Commission to operate on a permanent, rather than pilot, basis the
Exchange intends to assess whether additional changes should also be
made to the Options Pilots. Extending the Options Pilots for an
additional six months should provide the Exchange and other national
securities exchanges additional time to consider further amendments to
their rules in light of proposed Amendment 18.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the requirements of Section 6(b) of the Act,\7\ in general, and Section
6(b)(5) of the Act,\8\ in particular, in that it is designed to remove
impediments to and perfect the mechanism of a free and open market and
a national market system, to promote just and equitable principles of
trade, and, in general, to protect investors and the public interest
and not to permit unfair discrimination between customers, issuers,
brokers, or dealers. The Exchange believes that the proposed rule
change promotes just and equitable principles of trade in that it
promotes transparency and uniformity across markets concerning rules
for options markets adopted to coincide with the Plan. The Exchange
believes that extending the Options Pilots for an additional six months
would help assure that the rules subject to such Pilots are either
similarly made permanent, amended or removed, following additional
discussion and analysis by the Exchange and other national securities
exchanges. The proposed rule change would also help assure that such
rules are not immediately eliminated, thus furthering fair and orderly
markets, the protection of investors and the public interest. Based on
the foregoing, the Exchange believes the Options Pilots should continue
to be in effect on a pilot basis while the Exchange and the other
national securities exchanges consider and develop a permanent proposal
for such rules.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change would
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposal would ensure
the continued, uninterrupted operation of the Options Pilots while the
Exchange and other national securities exchanges consider further
amendments to these rules in light of proposed Amendment 18. The
Exchange understands that the other national securities exchanges will
also file similar proposals to extend their respective pilot programs.
Thus, the proposed rule change will help to ensure consistency across
market centers without implicating any competitive issues.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No comments were solicited or received on the proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A)(iii) of the Act \9\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\10\
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \10\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \11\ normally
does not become operative prior to 30 days after the date of the
filing. However, Rule 19b-4(f)(6)(iii) \12\ permits the Commission to
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposed
rule change may become effective and operative immediately upon filing.
The Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest, as
it will allow the current Options Pilots to continue uninterrupted,
without any changes, while the Exchange and the other national
securities exchanges consider and develop a permanent proposal for
Options Pilots. For this reason, the Commission hereby waives the 30-
day operative delay and designates the proposed rule change as
operative upon filing.\13\
---------------------------------------------------------------------------

    \11\ 17 CFR 240.19b-4(f)(6).
    \12\ 17 CFR 240.19b-4(f)(6)(iii).
    \13\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act.

Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-C2-2019-008 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File Number SR-C2-2019-008. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-C2-2019-008 and should be submitted on
or before May 8, 2019.

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

    \14\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-07618 Filed 4-16-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: February 3, 2009 (Volume 74, Number 21)]
[Notices]
[Page 5928-5929]
[DOCID:fr03fe09-25]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13356-000]

Slatersville Hydro, LLC; Notice of Application Tendered for
Filing With the Commission, Soliciting Additional Study Requests, and
Establishing Procedural Schedule for Licensing and Deadline for
Submission of Final Amendments

January 27, 2009.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Exemption From Licensing.
    b. Project No.: P-13356-000.
    c. Date Filed: January 15, 2009.
    d. Applicant: Slatersville Hydro, LLC.
    e. Name of Project: Slatersville Hydroelectric Project.
    f. Location: On the Branch River in Providence County, Rhode
Island. The project would not occupy any land of the United States.
    g. Filed Pursuant to: Public Utilities Regulatory Policies Act of
1978, 16 U.S.C. 2705, 2708.
    h. Applicant Contact: Michael P. DeFrancesco, 87 Hall Road, Exeter,
RI 02822,<PHONE_NUMBER>.
    i. FERC Contact: Tom Dean,<PHONE_NUMBER>.
    j. Cooperating Agencies: We are asking Federal, state, and local
agencies and Indian tribes with jurisdiction and/or special expertise
with respect to environmental issues to cooperate with us in the
preparation of the environmental document. Agencies who would like to
request cooperating status should follow the instructions for filing
comments described in item l below.
    k. Pursuant to Section 4.32(b)(7) of 18 CFR of the Commission's
regulations, if any resource agency, Indian Tribe, or person believes
that an additional scientific study should be conducted in order to
form an adequate factual basis

for a complete analysis of the application on its merit, the resource
agency, Indian Tribe, or person must file a request for a study with
the Commission not later than 60 days from the date of filing of the
application, and serve a copy of the request on the applicant.
    l. Deadline for filing additional study requests and requests for
cooperating agency status: March 16, 2009.
    All documents (original and eight copies) should be filed with:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426.
    Additional study requests and requests for cooperating agency
status may be filed electronically via the internet in lieu of paper.
The Commission strongly encourages electronic filings. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
at (http://www.ferc.gov) under the ``eFiling'' link.
    m. This application is not ready for environmental analysis at this
time.
    n. Description of Project: The Slatersville Project would consist
of: (1) The existing upper 13-foot-high RI Dam No. 43 consisting of:
(a) An existing 175-foot-long spillway; and (b) a westerly abutment
equipped with two 3.5-foot-wide, 5.7-foot-high sluice gates impounding;
(2) an 172-reservoir with a normal water surface elevation of 250.7
feet National Geodetic Vertical Datum 1988 (NGVD) leading to; (3) two
new 150-foot-long, 4.5-foot-diameter penstocks connecting; (4) a new
powerhouse containing two generating units with a total installed
capacity of 360 kilowatts; (5) a new 25-foot-long tailrace discharging
water back into the Branch River; and (6) appurtenant facilities. The
project would have an average annual generation of about 1,250
megawatt-hours.
    In addition to a new powerhouse, penstocks, and tailrace, project
facilities would consist of: (1) New 1.5-foot-high flashboards on top
of RI Dam No. 43; and (2) a new 0.5-mile-long, 13.8 kilovolt
transmission line.
    Project facilities may also include: (1) The existing lower 6-foot-
high RI Dam No. 45 with a 105-foot-long spillway impounding; (2) the
existing 0.3-acre reservoir with a normal water surface elevation of
231.9 feet NGVD located in the bypassed reach between RI Dam No. 43 and
the new tailrace.
    o. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the three digits in the docket
number field to access the document. For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>or toll free at (866)
208-3676, or for TTY, contact<PHONE_NUMBER>. A copy is also available
for inspection and reproduction at the address in item h above.
    You may also register online at http://www.ferc.gov/docs-filing/
esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    p. With this notice, we are initiating consultation with the Rhode
Island State Historic Preservation Officer (SHPO), as required by
section 106, National Historic Preservation Act, and the regulations of
the Advisory Council on Historic Preservation, 36 CFR 800.4.
    q. Procedural schedule and final amendments: The application will
be processed according to the following Hydro Licensing Schedule.
Revisions to the schedule will be made as appropriate. The Commission
staff proposes to issue one environmental assessment rather than issue
a draft and final EA. Comments, terms and conditions, recommendations,
prescriptions, and reply comments, if any, will be addressed in an EA.
Staff intends to give at least 30 days for entities to comment on the
EA, and will take into consideration all comments received on the EA
before final action is taken on the license application.
    Issue Acceptance Letter or Deficiency Letter--April 2009.
    Issue Scoping Document--May 2009.
    Notice of application is ready for environmental analysis--June
2009.
    Notice of the availability of the EA--November 2009.
    Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of the notice
of ready for environmental analysis.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-2217 Filed 2-2-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 103 (Wednesday, May 29, 2019)]
[Rules and Regulations]
[Pages 24703-24705]
[FR Doc No: 2019-10773]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0726; Product Identifier 2017-SW-097-AD; Amendment
39-19638; AD 2019-09-04]
RIN 2120-AA64

Airworthiness Directives; Leonardo S.p.A. (Type Certificate
Previously Held by Finmeccanica S.p.A., AgustaWestland S.p.A)
Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Leonardo S.p.A. (Type Certificate previously held by Finmeccanica
S.p.A., AgustaWestland S.p.A.) Model AW109SP helicopters. This AD
requires inspecting and altering the rescue hoist. This AD was prompted
by a report of a damaged hoist cable that detached after load
application. The actions of this AD are intended to address an unsafe
condition on these products.

DATES: This AD is effective July 3, 2019.
    The Director of the Federal Register approved the incorporation by
reference of a certain document listed in this AD as of July 3, 2019.

ADDRESSES: For service information identified in this final rule,
contact Leonardo S.p.A. Helicopters, Matteo Ragazzi, Head of
Airworthiness, Viale G.Agusta 520, 21017 C.Costa di Samarate (Va)
Italy; telephone +39-0331-711756; fax +39-0331-229046; or at https://www.leonardocompany.com/en/home. 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. It is
also available on the internet at http://www.regulations.gov by
searching for and locating Docket No. FAA-2018-0726.

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-2018-
0726; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, the European Aviation Safety Agency (EASA) AD, any
incorporated-by-reference service information, the regulatory
evaluation, any comments received, and other information. The street
address for Docket Operations (phone:<PHONE_NUMBER>) is U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: David Hatfield, Aviation Safety
Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA,
10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain Leonardo S.p.A.
(formerly Finmeccanica S.p.A, AgustaWestland S.p.A.) Model AW109SP
helicopters. The NPRM published in the Federal Register on August 21,
2018 (83 FR 42230). The NPRM was prompted by a report of a damaged
hoist cable that detached after load application. The NPRM proposed to
require inspecting and altering the rescue hoist.
    We are issuing this AD to address chafing of a rescue hoist cable.
This condition could result in detachment of an external load and
subsequent injury to persons being lifted.
    EASA, which is the Technical Agent for the Member States of the
European Union, has issued AD No. 2017-0025, dated February 14, 2017,
to correct an unsafe condition for certain Leonardo S.p.A. (formerly
Finmeccanica S.p.A. and AgustaWestland S.p.A.) Model AW109SP
helicopters. EASA advises that a hoist cable became snagged behind a
hoist handle assembly nut and broke during a dummy load application.
EASA further advises that this condition could result in detachment of
an external load, and subsequent personal injury or injury to persons
on the ground. To address this unsafe condition, the EASA AD requires
inspecting the hoist cable, modifying the rescue hoist handle, and
amending the rescue hoist pre-flight inspection described in the
rotorcraft flight manual.

Comments

    We gave the public the opportunity to participate in developing
this final rule. We have considered the comment received. One commenter
commented in support of the NPRM.

FAA's Determination

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

Related Service Information Under 1 CFR Part 51

    Leonardo S.p.A. issued Leonardo Helicopters Bollettino Tecnico No.
109SP-110, dated February 13, 2017, which contains procedures for
inspecting the hoist handle, the passenger-side cabin doorframe, and
the hoist cable. This service information also specifies replacing the
attaching hardware on the rescue hoist handle and adding a temporary
pre-flight check of the hoist cable to the rotorcraft flight manual.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Differences Between This AD and the EASA AD

    The EASA AD requires amending the rotorcraft flight manual by
adding a daily rescue hoist cable preflight inspection, this AD does
not since the actions in this AD correct the unsafe condition.

Costs of Compliance

    We estimate that this AD affects 30 helicopters of U.S. Registry.
We estimate that operators may incur the following costs in order to
comply with this AD, based on an average labor rate of $85 per hour.
    Inspecting the hoist handle assembly, cabin doorframe, and hoist
cable requires about 2 hours, for a cost of $170 per helicopter and
$5,100 for the U.S. fleet. Replacing the hardware on the hoist handle
assembly requires about 1 hour and required parts costs are minimal,
for a cost of $85 per helicopter and $2,550 for the U.S. fleet.
    If required, replacing a hoist cable requires about 3 hours and
required parts cost $3,150, for a cost per helicopter of $3,405.
    According to Leonardo Helicopters' service information, some of the
costs of this AD may be covered under warranty, thereby reducing the
cost impact on affected individuals. We do not control warranty
coverage by Leonardo Helicopters. Accordingly, we have included all
costs in our cost estimate.

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

    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):

2019-09-04 Leonardo S.p.A. (Type Certificate Previously Held by
Finmeccanica S.p.A., AgustaWestland S.p.A.): Amendment 39-19638;
Docket No. FAA-2018-0726; Product Identifier 2017-SW-097-AD.

(a) Applicability

    This AD applies to Leonardo S.p.A. (Type Certificate previously
held by Finmeccanica S.p.A., AgustaWestland S.p.A.) Model AW109SP
helicopters, certificated in any category, with a rescue hoist part
number 109-B810-16-101 or 109-B810-16-201 installed.

(b) Unsafe Condition

    This AD defines the unsafe condition as chafing of a rescue
hoist cable. This condition could result in detachment of an
external load and subsequent injury to persons being lifted.

(c) Effective Date

    This AD is effective July 3, 2019.

(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

    (1) Within 10 hours time-in-service (TIS) or before the next
hoist operation, whichever occurs first, inspect the rescue hoist
handle assembly and the upper part of the cabin doorframe for
chafing. The inspection area of the cabin doorframe is depicted in
Figure 3 of Leonardo Helicopters Bollettino Tecnico No. 109SP-110,
dated February 13, 2017 (BT 109SP-110). Examples of chafing are
shown in Figures 10 and 11 of BT 109SP-110. If there is any chafing,
before further flight, repair the chafed areas and inspect the first
6 meters (20 feet) of the hoist cable as follows:
    (i) Measure the diameter of the hoist cable as described in the
Compliance Instructions, Part I, paragraphs 3.4.1 through 3.4.2 of
BT 109SP-110.

    (ii) Average the two measurements at each location. If at any
location the diameter of the hoist cable is less than 4.7 mm (0.185
inch), before the next hoist operation, remove the hoist cable from
service.
    (iii) Inspect the hoist cable for broken wires, kinks, bird
caging, flattened areas, abrasion, and necking, referencing the
examples shown and depicted in Figures 5 through 9 of BT 109SP-110.
If there are any broken wires, kinks, bird caging, flattened areas,
abrasion, or necking, before the next hoist operation, remove the
hoist cable from service.
    (2) Within 25 hours TIS, replace the rescue hoist handle
attaching hardware as described in the Compliance Instructions, Part
II, paragraphs 3 through 6, of BT 109SP-110.

(f) Special Flight Permits

    A one-time special flight permit may be granted provided that
the hoist is not used.

(g) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Section, Rotorcraft Standards
Branch, FAA, may approve AMOCs for this AD. Send your proposal to:
David Hatfield, Aviation Safety Engineer, Safety Management Section,
Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy., Fort Worth,
TX 76177; telephone<PHONE_NUMBER>; 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.

(h) Additional Information

    The subject of this AD is addressed in European Aviation Safety
Agency (EASA) AD No. 2017-0025, dated February 14, 2017. You may
view the EASA AD on the internet at http://www.regulations.gov in
Docket No. FAA-2018-0726.

(i) Subject

    Joint Aircraft Service Component (JASC) Code: 2500, Cabin
Equipment/Furnishings.

(j) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Leonardo Helicopters Bollettino Tecnico No. 109SP-110, dated
February 13, 2017.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact
Leonardo S.p.A. Helicopters, Matteo Ragazzi, Head of Airworthiness,
Viale G.Agusta 520, 21017 C.Costa di Samarate (Va) Italy; telephone
+39-0331-711756; fax +39-0331-229046; or at https://www.leonardocompany.com/en/home.
    (4) You may view this service information at FAA, Office of the
Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-
321, Fort Worth, TX 76177. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibrlocations.html.

    Issued in Fort Worth, Texas, on May 15, 2019.
Helene Gandy,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2019-10773 Filed 5-28-19; 8:45 am]
 BILLING CODE 4910-13-P