[Federal Register Volume 86, Number 125 (Friday, July 2, 2021)]
[Notices]
[Pages 35305-35307]
[FR Doc No: 2021-14194]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-0938]

Evaluating Cancer Drugs in Patients With Central Nervous System
Metastases; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Evaluating Cancer Drugs
in Patients with Central Nervous System Metastases; Guidance for
Industry.'' The guidance document provides recommendations regarding
the design of clinical trials of drugs and biological products
regulated by the Center for Drug Evaluation and Research (CDER) and the
Center for Biologics Evaluation and Research (CBER) that are intended
to support product labeling describing the antitumor activity in
patients with central nervous system (CNS) metastases from solid tumors
originating outside the CNS. The guidance includes study design
recommendations regarding the patient population, available therapy,
prior therapies, assessment of CNS disease, study endpoints, and
leptomeningeal disease. The guidance announced in this notice finalizes
the draft guidance of the same title dated August 2020.

DATES: The announcement of the guidance is published in the Federal
Register on July 2, 2021.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-D-0938 for ``Evaluating Cancer Drugs in Patients with Central
Nervous System Metastases.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist the office in processing
your requests. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Shanthi Marur, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2369, Silver Spring, MD 20993-0002, 240-
402-6373; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled
``Evaluating Cancer Drugs in Patients with Central Nervous System
Metastases.'' This guidance provides recommendations for sponsors
designing clinical trials of drugs and biological products regulated by
CDER and CBER that are intended to support product labeling describing
the antitumor activity in patients with CNS metastases from solid
tumors originating outside the CNS. Specifically, the guidance includes
recommendations regarding the patient population, available therapy,
prior therapies, assessment of CNS disease, study endpoints, and
leptomeningeal disease. The guidance describes that CNS metastases
should be evaluated in the context of the entire disease burden and
discusses how treatment effects may be described in drug labeling. The
recommendations pertain to clinical trials for systemic anticancer
drugs where patients with CNS metastases are included in the study
population. These recommendations are also applicable to

trials conducted exclusively in patients with CNS metastases.
    CNS metastases are associated with significant morbidity and
mortality and development of therapeutic products for patients with CNS
metastases is needed. FDA has participated in efforts to facilitate
drug development for patients with CNS metastases, including a March
2019 ``Workshop on Product Development for CNS Metastases.''
Stakeholders at this meeting stated there is a need for further FDA
guidance on specific topics, including identifying optimal study
endpoints. Study design challenges for CNS metastases include
uncertainty regarding optimal endpoints, lack of standardized response
assessments, understanding how CNS metastases are evaluated in the
context of the entire burden of metastatic disease to characterize a
drug's potential benefit (e.g., timing of CNS radiographic assessments
relative to other sites of metastases), and interpreting radiographic
response in the setting of recent radiation therapy or surgery. This
guidance is intended to provide recommendations on these study design
challenges.
    In the Federal Register of August 27, 2020 (85 FR 53007), FDA
announced the availability of the draft guidance ``Evaluating Cancer
Drugs in Patients with Central Nervous System Metastases'' dated August
2020. FDA received several comments on the draft guidance and those
comments were considered as the guidance was finalized. A summary of
changes includes: Clarification on the number of stratification factors
the protocol should specify in order to minimize bias, confirmation of
the version of Response Evaluation Criteria in Solid Tumours (RECIST)
that should be referred to when evaluating CNS disease, clarification
that both CNS and systematic duration of response should be captured
and the addition of a 6-month timepoint, and the addition of
progression-free survival in patients with brain metastasis as another
measurement to be reported when CNS is a common metastatic site. In
addition, editorial changes were made to improve clarity. The guidance
announced in this notice finalizes the draft guidance dated August 27,
2020.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Evaluating Cancer Drugs in Patients with
Central Nervous System Metastases.'' It does not establish any rights
for any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312 have been approved under OMB control
number 0910-0014; the collections of information in 21 CFR part 314
have been approved under OMB control number 0910-0001; the collections
of information in 21 CFR part 601 have been approved under 0910-0338;
and the collections of information in 21 CFR 201.56 and 201.57 have
been approved under OMB control number 0910-0572.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances or
https://www.regulations.gov.

    Dated: June 28, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-14194 Filed 7-1-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 118 (Thursday, June 19, 2014)]
[Rules and Regulations]
[Pages 35046-35048]
[FR Doc No: 2014-14412]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2014-0180]
RIN 1625-AA00

Safety Zone; Arts Project Cherry Grove Pride Week Fireworks
Display; Great South Bay, Cherry Grove, Fire Island, NY

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on the
navigable waters of Great South Bay near Cherry Grove, Fire Island, NY
for the Arts Project Cherry Grove Pride Week fireworks display. This
action is necessary to provide for the safety of life on navigable
waters during the event. The safety zone will facilitate public
notification of the event and provide protective measures for the
maritime public and event participants from the hazards associated with
the fireworks display. Entering into, transiting through, remaining,
anchoring or mooring within this regulated area would be prohibited
unless authorized by the Captain of the Port (COTP) Sector Long Island
Sound.

DATES: This rule is effective from June 21, 2014 to June 22, 2014. This
rule will be enforced from 8:30 p.m. until 10:30 p.m. on June 21, 2014.
If the event is cancelled due to inclement weather, then this
regulation will be enforced from 8:30 p.m. until 10:30 p.m. on June 22,
2014.

ADDRESSES: Documents mentioned in this preamble are part of docket
[USCG-2014-0180]. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking. You may also
visit the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Petty Officer Scott Baumgartner, Prevention Department,
Coast Guard Sector Long Island Sound,<PHONE_NUMBER>,
<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Cheryl Collins, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Regulatory History and Information

    On April 25, 2014 the Coast Guard published a notice of proposed
rulemaking (NPRM) entitled ``Safety Zone; Arts Project Cherry Grove
Pride Week Fireworks Display; Great South Bay; Cherry Grove, Fire
Island, NY'' in the Federal Register (79 FR 22916). No public comments
were received on the proposed rule. No public meeting was requested and
none was held.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. The Arts Project Cherry Grove
Pride Week fireworks display is scheduled for June 21, 2014. The
comment period for the NPRM associated with this event expired on May
27, 2014 providing insufficient time for a 30 day effective period. The
event sponsor is unwilling and unable to postpone the event because of
financial and logistical concerns. The fireworks display is scheduled
to coincide with the Arts Project Cherry Grove Pride Week. Delaying the
event does not align with that goal and the many sponsors helping to
fund this event would be impacted as they have done so with the
expectation that it will coincide with Pride Week activities.
Furthermore, the planning and coordination with local authorities to
support this event was based around a June 21, 2014 event date with a
June 22, 2014 rain date and any last minute changes would be difficult
to accommodate.
    A safety zone is needed to protect the safety of life and property
on navigable waters from the hazards associated with this event and it
would be contrary to public interest to delay promulgating this rule by
delaying the effective date.

B. Basis and Purpose

    The legal basis for this temporary rule is 33 U.S.C. 1231; 46
U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1,
6.04-1, 6.04-6, and 160.5; Public Law 107-295, 116 Stat. 2064;
Department of Homeland Security Delegation No. 0170.1 which
collectively authorize the Coast Guard to define regulatory safety
zones.
    This temporary rule is necessary to promote the safety of life on
navigable waterways during the Arts Project Cherry Grove Pride Week
fireworks display in Great South Bay near Cherry Grove, Fire Island,
NY.

C. Discussion of Comments, Changes and the Final Rule

    The effective dates of the temporary final rule are June 21 2014
through June 22, 2014. The effective dates of this regulation have
changed from those listed in the NPRM because the event sponsor used
the wrong dates, a June 28, 2014 event date with a June 29, 2014 rain
date, in their marine event application to the Coast Guard. The event
is scheduled as part of Pride Week activities in Cherry Grove, NY which
end on June 22, 2014. No comments were received on the proposed rule.

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses

based on these statutes and executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders.
    The Coast Guard determined that this rulemaking would not be a
significant regulatory action for the following reasons: The regulated
area will be of limited duration, the area covers only a small portion
of the navigable waterways and waterway users may transit around the
area. Also, mariners may request permission from the COTP Sector Long
Island Sound or the designated representative to transit the zone.
    Advanced public notifications will also be made to the local
maritime community through the Local Notice to Mariners as well as
Broadcast Notice to Mariners.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard received zero comments from the Small Business
Administration on this rule. The Coast Guard certifies under 5 U.S.C.
605(b) that this rule will not have a significant economic impact on a
substantial number of small entities.
    This rule will affect the following entities, some of which may be
small entities: the owners or operators of vessels intending to enter,
transit, anchor or moor within the regulated area during the effective
period. The temporary safety zone will not have a significant economic
impact on a substantial number of small entities for the following
reasons: The regulated area will be of limited size and of short
duration and mariners may request permission from the COTP Sector Long
Island Sound or the designated representative to transit the zone.
Notifications will be made to the maritime community through the Local
Notice to Mariners and Broadcast Notice to Mariners well in advance of
the event.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT,
above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

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

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and determined
that this rule does not have implications for federalism.

6. Protest Activities

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

7. Unfunded Mandates Reform Act

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

8. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference With Constitutionally Protected Property
Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children From Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination With Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

12. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security

Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves the establishment of a safety zone.
This rule is categorically excluded from further review under paragraph
34(g) of Figure 2-1 of the Commandant Instruction. An environmental
analysis checklist supporting this determination and a Categorical
Exclusion Determination are available in the docket where indicated
under ADDRESSES. We seek any comments or information that may lead to
the discovery of a significant environmental impact from this rule.

List of Subjects in 33 CFR Part 165

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

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREA AND LIMITED ACCESS AREAS

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

    Authority:  33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703;
50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add Sec.  165.T01-0180 to read as follows:

Sec.  165.T01-0180  Safety Zone; Arts Project Cherry Grove Pride Week
Fireworks Display; Great South Bay; Cherry Grove, Fire Island, NY.

    (a) Location. The following area is a safety zone: All waters of
Great South Bay within a 600-foot radius of the fireworks barge located
about 400 yards north of the main dock at Cherry Grove, Fire Island, NY
in approximate position 40[deg]39'49.06'' N, 073[deg]05'27.99'' W North
American Datum 1983.
    (b) Enforcement Period. This rule will be enforced on June 21, 2014
from 8:30 p.m. until 10:30 p.m. If the event is postponed due to
inclement weather, then this rule will be enforced on June 22, 2014
from 8:30 p.m. until 10:30 p.m.
    (c) Regulations. The general regulations contained in 33 CFR 165.23
apply. During the enforcement period, entering into, transiting
through, remaining, mooring or anchoring within this safety zone is
prohibited unless authorized by the Captain of the Port (COTP) or the
designated representatives.
    (1) Definitions. The following definitions apply to this section:
    (i) Designated Representative. A ``designated representative'' is
any Coast Guard commissioned, warrant or petty officer of the U.S.
Coast Guard who has been designated by the COTP, Sector Long Island
Sound, to act on his or her behalf. The designated representative may
be on an official patrol vessel or may be on shore and will communicate
with vessels via VHF-FM radio or loudhailer. In addition, members of
the Coast Guard Auxiliary may be present to inform vessel operators of
this regulation.
    (ii) Official Patrol Vessels. Official patrol vessels may consist
of any Coast Guard, Coast Guard Auxiliary, state, or local law
enforcement vessels assigned or approved by the COTP Sector Long Island
Sound.
    (iii) Spectators. All persons and vessels not registered with the
event sponsor as participants or official patrol vessels.
    (2) Spectators desiring to enter or operate within the regulated
area should contact the COTP Sector Long Island Sound at<PHONE_NUMBER>
(Sector Long Island Sound command center) or the designated
representative via VHF channel 16 to obtain permission to do so.
Spectators given permission to enter or operate in the regulated area
must comply with all directions given to them by the COTP Sector Long
Island Sound or the designated on-scene representative.
    (3) Upon being hailed by an official patrol vessel or the
designated representative, by siren, radio, flashing light or other
means, the operator of the vessel shall proceed as directed. Failure to
comply with a lawful direction may result in expulsion from the area,
citation for failure to comply, or both.
    (4) Fireworks barges used in this location will have a sign on
their port and starboard side labeled ``FIREWORKS--STAY AWAY''. This
sign will consist of 10 inch high by 1.5 inch wide red lettering on a
white background.

    Dated: June 6, 2014.
E.J. Cubanski, III,
Captain, U.S. Coast Guard, Captain of the Port Sector Long Island
Sound.
[FR Doc. 2014-14412 Filed 6-18-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 79, Number 175 (Wednesday, September 10, 2014)]
[Notices]
[Pages 53700-53701]
[FR Doc No: 2014-21543]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 2

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER12-348-001.
    Applicants: Mercuria Energy America, Inc.
    Description: Compliance filing per 35: MEAI Electric Tariff to be
effective 9/3/2014.
    Filed Date: 9/2/14.
    Accession Number: 20140902-5115.
    Comments Due: 5 p.m. ET 9/23/14.

    Docket Numbers: ER14-639-001.
    Applicants: California Independent System Operator Corporation.
    Description: Compliance filing per 35: 2014-09-
02Order784SecondCompliance to be effective 9/2/2014.
    Filed Date: 9/2/14.
    Accession Number: 20140902-5112.

    Comments Due: 5 p.m. ET 9/23/14.

    Docket Numbers: ER14-836-001.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Report Filing: 2014-09-02SA 2622 Courtenay-
OTP E&PJ262-J263Response to be effective N/A.
    Filed Date: 9/2/14.
    Accession Number: 20140902-5179.
    Comments Due: 5 p.m. ET 9/23/14.

    Docket Numbers: ER14-1243-004.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Protest of Integrys Energy Services, Inc.
    Filed Date: 9/2/14.
    Accession Number: 20140902-5117.
    Comments Due: 5 p.m. ET 9/23/14.

    Docket Numbers: ER14-2753-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): 2028R9
Sunflower Electric Power Corporation NITSA NOA to be effective 8/1/
2014.
    Filed Date: 9/2/14.
    Accession Number: 20140902-5111.
    Comments Due: 5 p.m. ET 9/23/14.

    Docket Numbers: ER14-2754-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): 2014-
09-02SA 2289 Ameren-Hoopeston Wind 4th Revised H094 GIA to be
effective 9/3/2014.
    Filed Date: 9/2/14.
    Accession Number: 20140902-5113.
    Comments Due: 5 p.m. ET 9/23/14.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: September 2, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-21543 Filed 9-9-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 184 (Monday, September 25, 2017)]
[Proposed Rules]
[Pages 44541-44542]
[FR Doc No: 2017-20329]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2017-0721; Airspace Docket No. 17-AGL-15]

Proposed Amendment of Class E Airspace; Charlotte, MI

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to modify Class E airspace extending
upward from 700 feet above the surface at Fitch H. Beach Airport,
Charlotte, MI. The FAA is proposing this action due to the
decommissioning of the Lansing VHF omnidirectional range (VOR) and
collocated tactical air navigation (TACAN), which provided navigation
guidance for the instrument procedures to this airport. The VOR/TACAN
is being decommissioned as part of the VOR Minimum Operational Network
(MON) Program. This action would enhance safety and management of
instrument flight rules (IFR) operations at this airport. Additionally,
the geographic coordinates of the airport would be adjusted to coincide
with the FAA's aeronautical database.

DATES: Comments must be received on or before November 9, 2017.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590; telephone
(202) 366-9826, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2017-0721; Airspace Docket No. 17-AGL-15, at the beginning of your
comments. You may also submit comments through the Internet at http://www.regulations.gov. You may review the public docket containing the
proposal, any comments received, and any final disposition in person in
the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through
Friday, except Federal holidays.
    FAA Order 7400.11B, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11B at NARA, call<PHONE_NUMBER>, or go
to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

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
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 amend Class E airspace extending upward from 700 feet above
the surface at Fitch H. Beach Airport, Charlotte, MI,

to support IFR operations for instrument approach procedures at the
airport.

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 and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2017-0721/
Airspace Docket No. 17-AGL-15.'' The postcard will be date/time stamped
and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    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/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the 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 Federal Aviation Administration, Air Traffic
Organization, Central Service Center, Operations Support Group, 10101
Hillwood Parkway, Fort Worth, TX 76177.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11B, Airspace
Designations and Reporting Points, dated August 3, 2017, and effective
September 15, 2017. FAA Order 7400.11B is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11B lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 by modifying Class E airspace area
extending upward from 700 feet above the surface within a 6.4-mile
radius (increased from a 6.3-mile radius) at Fitch H. Beach, Charlotte,
MI, and updating the geographic coordinates of the airport to coincide
with the FAA's aeronautical database. The exclusionary language
contained in the airspace description is being removed to comply with
FAA Order 7400.2L, Procedures for Handling Airspace Matters.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.11B, dated August 3, 2017, and effective September 15,
2017, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in the Order.

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, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (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) 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, would 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 subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 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.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11B,
Airspace Designations and Reporting Points, dated August 3, 2017, and
effective September 15, 2017, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

AGL MI E5 Charlotte, MI [Amended]

Charlotte, Fitch H. Beach Airport, MI
    (Lat. 42[deg]34'27'' N., long. 84[deg]48'44'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.4-mile radius of the Fitch H. Beach Airport.

    Issued in Fort Worth, Texas, on September 13, 2017.
Walter Tweedy,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2017-20329 Filed 9-22-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 28 (Thursday, February 10, 2022)]
[Notices]
[Pages 7843-7844]
[FR Doc No: 2022-02858]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0556]

Development of Non-Opioid Analgesics for Acute Pain; Draft
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Development of Non-Opioid Analgesics for Acute Pain.'' In connection
with the SUPPORT for Patients and Communities Act (SUPPORT Act), the
purpose of this guidance is to spur the development of alternatives to
opioids for the management of acute pain by providing information about
product development-related issues, ``opioid-sparing'' claims, and
expedited programs as they pertain to this purpose.

DATES: Submit either electronic or written comments on the draft
guidance by April 11, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-N-0556 for ``Development of Non-Opioid Analgesics for Acute
Pain.'' Received comments will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the

electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Theresa Wells, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5373, Silver Spring, MD 20993-0002, 703-
380-3900.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Development of Non-Opioid Analgesics for Acute Pain.'' This
draft guidance is written in connection with section 3001 of the
SUPPORT Act to provide information that will be useful in the
development of non-opioid analgesics for the management of acute pain
and, thereby, spur the development of such products.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Development
of Non-Opioid Analgesics for Acute Pain.'' It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 314 have been approved under OMB control
number 0910-0001; the collections of information in 21 CFR part 312 for
conducting clinical trials and collecting data for such trials have
been approved under OMB control number 0910-0014; the collections of
information pertaining to Electronic Records and Electronic Signatures
have been approved under OMB control number 0910-0303; the collections
of information pertaining to the Requirements on Content and Format of
Labeling for Human Prescriptions for ``opioid-sparing'' claims have
been approved under OMB control number 0910-0572; and the collections
of information found in the Guidance for Industry on Expedited Programs
for Serious Condition--Drugs and Biologics for expedited pathways to
support the development program for non-opioid analgesics have been
approved under OMB control number 0910-0765.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: February 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-02858 Filed 2-9-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 251 (Friday, December 30, 2016)]
[Notices]
[Pages 96537-96539]
[FR Doc No: 2016-31684]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 32401; 812-14690]

Northern Lights Fund Trust IV and Blue Sky Asset Management, LLC;
Notice of Application

December 23, 2016.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of an application for an order under section 6(c) of the
Investment Company Act of 1940 (the ``Act'') for an exemption from
sections 2(a)(32), 5(a)(1), 22(d), and 22(e) of the Act and rule 22c-1
under the Act, under sections 6(c) and 17(b) of the Act for an
exemption from sections 17(a)(1) and 17(a)(2) of the Act, and under
section 12(d)(1)(J) for an exemption from sections 12(d)(1)(A) and
12(d)(1)(B) of the Act. The requested order would permit (a) index-
based series of certain open-end management investment companies
(``Funds'') to issue shares

redeemable in large aggregations only (``Creation Units''); (b)
secondary market transactions in Fund shares to occur at negotiated
market prices rather than at net asset value (``NAV''); (c) certain
Funds to pay redemption proceeds, under certain circumstances, more
than seven days after the tender of shares for redemption; (d) certain
affiliated persons of a Fund to deposit securities into, and receive
securities from, the Fund in connection with the purchase and
redemption of Creation Units; (e) certain registered management
investment companies and unit investment trusts outside of the same
group of investment companies as the Funds (``Funds of Funds'') to
acquire shares of the Funds; and (f) certain Funds (``Feeder Funds'')
to create and redeem Creation Units in-kind in a master-feeder
structure.

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Applicants:  Northern Lights Fund Trust IV (the ``Trust''), a Delaware
statutory trust registered under the Act as an open-end management
investment company, and Blue Sky Asset Management, LLC (the ``Initial
Adviser''), a Colorado limited liability company registered as an
investment adviser under the Investment Advisers Act of 1940 (the
``Advisers Act'').

Filing Dates:  The application was filed on August 16, 2016, and
amended on November 21, 2016.

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 by writing to the Commission's
Secretary and serving applicants with a copy of the request, personally
or by mail. Hearing requests should be received by the Commission by
5:30 p.m. on January 17, 2017, 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 writing to the
Commission's Secretary.

ADDRESSES: Secretary, Securities and Exchange Commission, 100 F Street
NE., Washington, DC 20549-1090; Applicants: Northern Lights Fund Trust
IV, 17605 Wright Street, Omaha, NE 68130, and Blue Sky Asset
Management, LLC, 6400 S. Fiddlers Green Circle, Suite 350, Greenwood
Village, CO 80111.

FOR FURTHER INFORMATION CONTACT: Deepak T. Pai, Senior Counsel, at
(202) 551-6876, or Mary Kay Frech, Branch Chief, at<PHONE_NUMBER>
(Division of Investment Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained via the
Commission's Web site by searching for the file number, or for an
applicant using the Company name box, at http://www.sec.gov/search/search.htm or by calling<PHONE_NUMBER>.

Summary of the Application

    1. Applicants request an order that would allow Funds to operate as
index exchange traded funds (``ETFs'').\1\ Fund shares will be
purchased and redeemed at their NAV in Creation Units only. All orders
to purchase Creation Units and all redemption requests will be placed
by or through an ``Authorized Participant'', which will have signed a
participant agreement with a broker-dealer that will be registered
under the Securities Exchange Act of 1934 (``Exchange Act'') (the
``Distributor''). Shares will be listed and traded individually on a
national securities exchange, where share prices will be based on the
current bid/offer market. Certain Funds will operate as Feeder Funds in
a master-feeder structure. Any order granting the requested relief
would be subject to the terms and conditions stated in the application.
---------------------------------------------------------------------------

    \1\ Applicants request that the order apply to the existing
series of the Trust that are index ETFs and any additional series of
the Trust, and any other open-end management investment company or
series thereof, that may be created in the future (each, included in
the term ``Fund''), each of which will operate as an ETF and will
track a specified index comprised of domestic or foreign equity and/
or fixed income securities (each, an ``Underlying Index''). Any Fund
will (a) be advised by the Initial Adviser or an entity controlling,
controlled by, or under common control with the Initial Adviser
(each, an ``Adviser'') and (b) comply with the terms and conditions
of the application.
---------------------------------------------------------------------------

    2. Each Fund will hold investment positions selected to correspond
generally to the performance of an Underlying Index. In the case of
Self-Indexing Funds, an affiliated person, as defined in section
2(a)(3) of the Act (``Affiliated Person''), or an affiliated person of
an Affiliated Person (``Second-Tier Affiliate''), of the Trust or a
Fund, of the Adviser, of any sub-adviser to or promoter of a Fund, or
of the Distributor will compile, create, sponsor or maintain the
Underlying Index.\2\
---------------------------------------------------------------------------

    \2\ Each Self-Indexing Fund will post on its Web site the
identities and quantities of the investment positions that will form
the basis for the Fund's calculation of its NAV at the end of the
day. Applicants believe that requiring Self-Indexing Funds to
maintain full portfolio transparency will help address, together
with other protections, conflicts of interest with respect to such
Funds.
---------------------------------------------------------------------------

    3. Shares will be purchased and redeemed in Creation Units and
generally on an in-kind basis. Except where the purchase or redemption
will include cash under the limited circumstances specified in the
application, purchasers will be required to purchase Creation Units by
depositing specified instruments (``Deposit Instruments''), and
shareholders redeeming their shares will receive specified instruments
(``Redemption Instruments''). The Deposit Instruments and the
Redemption Instruments will each correspond pro rata to the positions
in the Fund's portfolio (including cash positions) except as specified
in the application.
    4. Because shares will not be individually redeemable, applicants
request an exemption from section 5(a)(1) and section 2(a)(32) of the
Act that would permit the Funds to register as open-end management
investment companies and issue shares that are redeemable in Creation
Units only.
    5. Applicants also request an exemption from section 22(d) of the
Act and rule 22c-1 under the Act as secondary market trading in shares
will take place at negotiated prices, not at a current offering price
described in a Fund's prospectus, and not at a price based on NAV.
Applicants state that (a) secondary market trading in shares does not
involve a Fund as a party and will not result in dilution of an
investment in shares, and (b) to the extent different prices exist
during a given trading day, or from day to day, such variances occur as
a result of third-party market forces, such as supply and demand.
Therefore, applicants assert that secondary market transactions in
shares will not lead to discrimination or preferential treatment among
purchasers. Finally, applicants represent that share market prices will
be disciplined by arbitrage opportunities, which should prevent shares
from trading at a material discount or premium from NAV.
    6. With respect to Funds that effect creations and redemptions of
Creation Units in kind and that are based on certain Underlying Indexes
that include foreign securities, applicants request relief from the
requirement imposed by section 22(e) in order to allow such Funds to
pay redemption proceeds within fifteen calendar days following the
tender of Creation Units for redemption. Applicants assert that the
requested relief would not be inconsistent with the spirit and intent
of

section 22(e) to prevent unreasonable, undisclosed or unforeseen delays
in the actual payment of redemption proceeds.
    7. Applicants request an exemption to permit Funds of Funds to
acquire Fund shares beyond the limits of section 12(d)(1)(A) of the
Act; and the Funds, and any principal underwriter for the Funds, and/or
any broker or dealer registered under the Exchange Act, to sell shares
to Funds of Funds beyond the limits of section 12(d)(1)(B) of the Act.
The application's terms and conditions are designed to, among other
things, help prevent any potential (i) undue influence over a Fund
through control or voting power, or in connection with certain
services, transactions, and underwritings, (ii) excessive layering of
fees, and (iii) overly complex fund structures, which are the concerns
underlying the limits in sections 12(d)(1)(A) and (B) of the Act.
    8. Applicants request an exemption from sections 17(a)(1) and
17(a)(2) of the Act to permit persons that are Affiliated Persons, or
Second Tier Affiliates, of the Funds, solely by virtue of certain
ownership interests, to effectuate purchases and redemptions in-kind.
The deposit procedures for in-kind purchases of Creation Units and the
redemption procedures for in-kind redemptions of Creation Units will be
the same for all purchases and redemptions and Deposit Instruments and
Redemption Instruments will be valued in the same manner as those
investment positions currently held by the Funds. Applicants also seek
relief from the prohibitions on affiliated transactions in section
17(a) to permit a Fund to sell its shares to and redeem its shares from
a Fund of Funds, and to engage in the accompanying in-kind transactions
with the Fund of Funds.\3\ The purchase of Creation Units by a Fund of
Funds directly from a Fund will be accomplished in accordance with the
policies of the Fund of Funds and will be based on the NAVs of the
Funds.
---------------------------------------------------------------------------

    \3\ The requested relief would apply to direct sales of shares
in Creation Units by a Fund to a Fund of Funds and redemptions of
those shares. Applicants, moreover, are not seeking relief from
section 17(a) for, and the requested relief will not apply to,
transactions where a Fund could be deemed an Affiliated Person, or a
Second-Tier Affiliate, of a Fund of Funds because an Adviser or an
entity controlling, controlled by or under common control with an
Adviser provides investment advisory services to that Fund of Funds.
---------------------------------------------------------------------------

    9. Applicants also request relief to permit a Feeder Fund to
acquire shares of another registered investment company managed by the
Adviser having substantially the same investment objectives as the
Feeder Fund (``Master Fund'') beyond the limitations in section
12(d)(1)(A) and permit the Master Fund, and any principal underwriter
for the Master Fund, to sell shares of the Master Fund to the Feeder
Fund beyond the limitations in section 12(d)(1)(B).
    10. Section 6(c) of the Act permits the Commission to exempt any
persons or transactions from any provision of the Act if such exemption
is necessary or appropriate in the public interest and consistent with
the protection of investors and the purposes fairly intended by the
policy and provisions of the Act. Section 12(d)(1)(J) of the Act
provides that the Commission may exempt any person, security, or
transaction, or any class or classes of persons, securities, or
transactions, from any provision of section 12(d)(1) if the exemption
is consistent with the public interest and the protection of investors.
Section 17(b) of the Act authorizes the Commission to grant an order
permitting a transaction otherwise prohibited by section 17(a) if it
finds that (a) the terms of the proposed transaction are fair and
reasonable and do not involve overreaching on the part of any person
concerned; (b) the proposed transaction is consistent with the policies
of each registered investment company involved; and (c) the proposed
transaction is consistent with the general purposes of the Act.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Brent J. Fields,
Secretary.
[FR Doc. 2016-31684 Filed 12-29-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 5 (Friday, January 8, 2021)]
[Notices]
[Pages 1495-1496]
[FR Doc No: 2021-00114]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2019-0238; FRL-10017-46]

1,4-Dioxane; Final Toxic Substances Control Act (TSCA) Risk
Evaluation; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is announcing the
availability of the final Toxic Substances Control Act (TSCA) risk
evaluation of 1, 4-dioxane. The purpose of conducting risk evaluations
under TSCA is to determine whether a chemical substance presents an
unreasonable risk of injury to health or the environment under the
conditions of use, including an unreasonable risk to a relevant
potentially exposed or susceptible subpopulation, without consideration
of costs or other nonrisk factors. EPA has determined that specific
conditions of use of 1, 4-dioxane present an unreasonable risk of
injury to health or the environment. For those conditions of use for
which EPA has found an unreasonable risk, EPA must take regulatory
action to address that unreasonable risk through risk management
measures enumerated in TSCA. EPA has also determined that specific
conditions of use do not present an unreasonable risk of injury to
health or the environment. For those conditions of use for which EPA
has found no unreasonable risk of injury to health or the environment,
the Agency's determination is a final Agency action and is issued via
order in the risk evaluation.

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2019-0238, is available online
at http://www.regulations.gov or in-person at the Office of Pollution
Prevention and Toxics Docket (OPPT Docket), Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. The Public Reading
Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone number for the Public Reading
Room is<PHONE_NUMBER>, and the telephone number for the OPPT Docket is
(202) 566-0280.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Public Reading Room are closed to visitors
with limited exceptions. The EPA/DC staff continue to provide remote
customer service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Yvette Selby-Mohamadu, Office of Pollution Prevention and Toxics
(7403M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. This action may
be of interest to persons who are or may be interested in risk
evaluations of chemical substances under TSCA, 15 U.S.C. 2601 et seq.
Since other entities may also be interested in this final risk
evaluation, the EPA has not attempted to describe all the specific
entities that may be affected by this action.

B. What is EPA's authority for taking this action?

    TSCA section 6, 15 U.S.C. 2605, requires EPA to conduct risk
evaluations to ``determine whether a chemical substance presents an
unreasonable risk of injury to health or the environment, without
consideration of costs or other nonrisk factors, including an
unreasonable risk to a potentially exposed or susceptible subpopulation
identified as relevant to the risk evaluation by the Administrator,
under the conditions of use.'' 15 U.S.C. 2605(b)(4)(A). TSCA sections
6(b)(4)(A) through (H) enumerate the deadlines and minimum requirements
applicable to this process, including provisions that provide
instruction on chemical substances that must undergo evaluation, the
minimum components of a TSCA risk evaluation, and the timelines for
public comment and completion of the risk evaluation. TSCA also
requires that EPA operate in a manner that is consistent with the best
available science, make decisions based on the weight of the scientific
evidence and consider the reasonably available information. 15 U.S.C.
2625(h), (i), and (k). TSCA section 6(i) directs that a determination
of ``no unreasonable risk'' shall be issued by order and considered to
be a final Agency action, while a determination of ``unreasonable
risk'' is not considered to be a final Agency action. 15 U.S.C.
2605(i).
    The statute identifies the minimum components for all chemical
substance risk evaluations. For each risk evaluation, EPA must publish
a document that outlines the scope of the risk evaluation to be
conducted, which includes the hazards, exposures, conditions of use,
and the potentially exposed or susceptible subpopulations that EPA
expects to consider. 15 U.S.C. 2605(b)(4)(D). The statute further
provides that each risk evaluation must also: (1) Integrate and assess
available information on hazards and exposures for the conditions of
use of the chemical substance, including information that is relevant
to specific risks of injury to health or the environment and
information on relevant potentially exposed or susceptible
subpopulations; (2) describe whether aggregate or sentinel exposures
were considered and the basis for that consideration; (3) take into
account, where relevant, the likely duration, intensity, frequency, and
number of exposures under the conditions of use; and (4) describe the
weight of the scientific evidence for the identified hazards and
exposures. 15 U.S.C. 2605(b)(4)(F)(i) through (ii) and (iv) through
(v). Each risk evaluation

must not consider costs or other nonrisk factors. 15 U.S.C.
2605(b)(4)(F)(iii).
    The statute requires that the risk evaluation process be completed
within a specified timeframe and provide an opportunity for public
comment on a draft risk evaluation prior to publishing a final risk
evaluation. 15 U.S.C. 2605(b)(4).
    Subsection 5.4.1 of the final risk evaluation for 1, 4-dioxane
constitutes the order required under TSCA section 6(i)(1), and the ``no
unreasonable risk'' determinations in that subsection are considered to
be a final Agency action effective on the date of issuance of the
order. In conducting risk evaluations, ``EPA will determine whether the
chemical substance presents an unreasonable risk of injury to health or
the environment under each condition of use within the scope of the
risk evaluation . . . .'' 40 CFR 702.47. Under EPA's implementing
regulations, ``[a] determination by EPA that the chemical substance,
under one or more of the conditions of use within the scope of the risk
evaluation, does not present an unreasonable risk of injury to health
or the environment will be issued by order and considered to be a final
Agency action, effective on the date of issuance of the order.'' 40 CFR
702.49(d). For purposes of TSCA section 19(a)(1)(A), the date of
issuance of the TSCA section 6(i)(1) order for 1, 4-dioxane shall be at
1:00 p.m. Eastern time (standard or daylight, as appropriate) on the
date that is two weeks after the date when this notice is published in
the Federal Register, which is in accordance with 40 CFR 23.5.

C. What action is EPA taking?

    EPA is announcing the availability of the risk evaluation of the
chemical substance identified in Unit II. In this risk evaluation, EPA
has made unreasonable risk determinations on some of the conditions of
use within the scope of the risk evaluation for this chemical. For
those conditions of use for which EPA has found an unreasonable risk of
injury to health or the environment, EPA must initiate regulatory
action to address those risks through risk management measures
enumerated in 15 U.S.C. 2605(a).
    EPA also is announcing the availability of the information required
to be provided publicly with each risk evaluation, which is available
online at http://www.regulations.gov in the dockets identified. 40 CFR
702.51. Specifically, EPA has provided:
     The scope document and problem formulation (in Docket ID
No. EPA-HQ-OPPT-2016-0723);
     Draft risk evaluation, supplemental analysis to the draft
risk evaluation, and final risk evaluation (in Docket ID No. EPA-HQ-
OPPT-2019-0238);
     All notices, determinations, findings, consent agreements,
and orders (in Docket ID No. EPA-HQ-OPPT-2019-0238);
     Any information required to be provided to the Agency
under 15 U.S.C. 2603 (in Docket ID No. EPA-HQ-OPPT-2016-0723 and Docket
ID No. EPA-HQ-OPPT-2019-0238);
     A nontechnical summary of the risk evaluation (in Docket
ID No. EPA-HQ-OPPT-2019-0238);
     A list of the studies, with the results of the studies,
considered in carrying out each risk evaluation (Risk Evaluation for 1,
4-dioxane) in Docket ID No. EPA-HQ-OPPT-2019-0238);
     The final peer review report, including the response to
peer review and public comments received during peer review (in Docket
ID No. EPA-HQ-OPPT-2019-0238); and
     Response to public comments received on the draft scope,
the draft risk evaluation and the supplemental analysis to the draft
risk evaluation (in Docket ID No. EPA-HQ-OPPT-2019-0238).

II. TSCA Risk Evaluation

A. What is EPA's risk evaluation process for existing chemicals under
TSCA?

    The risk evaluation process is the second step in EPA's existing
chemical review process under TSCA, following prioritization and before
risk management. As this chemical is one of the first ten chemical
substances undergoing risk evaluation, the chemical substance was not
required to go through prioritization (81 FR 91927, December 19, 2016)
(FRL-9956-47). The purpose of conducting risk evaluations is to
determine whether a chemical substance presents an unreasonable risk of
injury to health or the environment under the conditions of use,
including an unreasonable risk to a relevant potentially exposed or
susceptible subpopulation. As part of this process, EPA must evaluate
both hazard and exposure, not consider costs or other nonrisk factors,
use reasonably available information and approaches in a manner that is
consistent with the requirements in TSCA for the use of the best
available science, and ensure decisions are based on the weight of the
scientific evidence.
    The specific risk evaluation process that EPA has established by
rule to implement the statutory process is set out in 40 CFR part 702
and summarized on EPA's website at http://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluations-existing-chemicals-under-tsca. As explained in the preamble to EPA's final rule on
procedures for risk evaluation (82 FR 33726, July 20, 2017) (FRL-9964-
38), the specific regulatory process set out in 40 CFR part 702,
subpart B is being followed for the first ten chemical substances
undergoing risk evaluation to the maximum extent practicable.
    Prior to the publication of this final risk evaluation, a draft
risk evaluation was subject to peer review and public comment and a
supplemental analysis to the draft risk evaluation was subject to
public comment. EPA reviewed the report from the peer review committee
and public comments and has amended the risk evaluation in response to
these comments as appropriate. The public comments, peer review report,
and EPA's response to comments is in Docket ID No. EPA-HQ-OPPT-2019-
0238. Prior to the publication of the draft risk evaluation, EPA made
available the scope and problem formulation, and solicited public input
on uses and exposure. EPA's documents and the public comments are in
Docket ID No. EPA-HQ-OPPT-2016-0723. Additionally, information about
the scope, problem formulation, and draft risk evaluation phases of the
TSCA risk evaluation for this chemical is available at EPA's website at
https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluation-14-dioxane.

B. What is 1, 4-dioxane?

    1,4-dioxane is used primarily as a solvent in a variety of
commercial and industrial applications like in the manufacture of other
chemicals, as a processing aid, a laboratory chemical, and in adhesives
and sealants. 2016 CDR data shows that there were two manufacturers
producing or importing 1,059,980 pounds of 1,4-dioxane in the U.S. in
2015.

    Authority: 15 U.S.C. 2601 et seq.

Andrew Wheeler,
Administrator.
[FR Doc. 2021-00114 Filed 1-7-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: March 1, 2006 (Volume 71, Number 40)]
[Notices]
[Page 10498-10499]
[DOCID:fr01mr06-51]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM01-10-007]

Standards of Conduct for Transmission Providers; Notice of
Technical Conference and Workshop

February 23, 2006.
    The Federal Energy Regulatory Commission (Commission) will hold a
technical conference and workshop on Standards of Conduct for
Transmission

Providers and on April 7, 2006, in Phoenix/Scottsdale, Arizona. The
meeting is expected to begin at 9:30 a.m. (MT) and conclude late
afternoon. The details regarding the time and place will be provided in
the near future. All interested persons are invited to attend.
    The purpose of the conference and workshop is to discuss Standards
of Conduct for Transmission Providers under Order No. 2004.\1\ The
Commission is hosting this conference and workshop to help provide
guidance on complying with the Standards of Conduct that have been in
effect since September 2004. Interested persons are invited to submit
specific questions or issues that they would like to have addressed at
the conference and workshop or other suggestions for the content of the
program. Prospective attendees and participants are urged to watch for
further notices; a detailed agenda will be issued in advance of the
conference and workshop.
---------------------------------------------------------------------------

    \1\ Standards of Conduct for Transmission Providers, Order No.
2004, FERC Stats. & Regs., Regulations Preambles ] 31,155 (2003),
order on reh'g, Order No. 2004-A, III FERC Stats. & Regs. ] 31,161
(2004), 107 FERC ] 61,032 (2004), order on reh'g, Order No. 2004-B,
III FERC Stats. & Regs. ] 31,166 (2004), 108 FERC ] 61,118 (2004),
order on reh'g, Order No. 2004-C, 109 FERC ] 61,325 (2004), order on
reh'g, Order No. 2004-D, 110 FERC ] 61,320 (2005), National Fuel Gas
Supply Corp., et al. v. FERC, Nos. 04-1188, et al. (D.C. Cir. Filed
June 9, 2004).
---------------------------------------------------------------------------

    There is no registration fee to attend this conference. However, we
request that those planning to attend the conference register online on
the Commission's Web site at http://www.ferc.gov/whats-new/registration/sc-0407-form.asp
.

    Questions on complying with the regulations, suggestions of issues
to be addressed and requests to participate should be submitted by
March 15, 2006. Questions about the conference and workshop, including
requests to participate, should be directed to:

Demetra Anas, Office of Market Oversight and Investigations, Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426,<PHONE_NUMBER><EMAIL_ADDRESS>
Magalie R. Salas,
Secretary.
[FR Doc. E6-2873 Filed 2-28-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 218 (Thursday, November 10, 2016)]
[Proposed Rules]
[Pages 78947-78949]
[FR Doc No: 2016-27041]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-9382; Directorate Identifier 2016-CE-032-AD]
RIN 2120-AA64

Airworthiness Directives; Alexander Schleicher GmbH & Co. Gliders

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

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
Alexander Schleicher GmbH & Co. Model ASK 21 gliders. This proposed AD
results from mandatory continuing airworthiness information (MCAI)
originated 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 cable slack in gliders equipped with a rudder
hand control system leading to a short-term blockage of the rudder
control system and reduced control. We are issuing this proposed AD to
correct the unsafe condition on these products.

DATES: We must receive comments on this proposed AD by December 27,
2016.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Alexander Schleicher GmbH & Co., Segelflugzeugbau, Germany, Alexander
Schleicher Str. 1, D-36163 Poppenhausen (Wasserkuppe), telephone: +49
6658 89-0; fax: +49 6658 89-40; email<EMAIL_ADDRESS>
Internet: http://www.alexander-schleicher.de/en/flugzeuge/ask-21/. You
may review this 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.

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-2016-
9382; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Office (telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments
will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Jim Rutherford, Aerospace Engineer,
FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2016-9382;
Directorate Identifier 2016-CE-032-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
AD No.: 2016-0192, dated September 28, 2016 (referred to after this as
``the MCAI''), to correct an unsafe condition for the specified
products. The MCAI states:

    A temporary rudder control blockage was reported, involving an
ASK 21 sailplane equipped with a rudder hand control system.

The subsequent investigation revealed significant cable slack in the
rudder control system.
    This condition, if not detected and corrected, could lead to
reduced rudder control, possibly resulting in reduced
controllability of the sailplane.
    To address this potentially unsafe condition, Schleicher issued
ASK 21 Technical Note (TN) 38 to provide instructions to amend the
ASK 21 Aircraft Flight Manual (AFM), incorporating updated pre-
flight inspection instructions to check the rudder control system of
sailplanes modified in accordance with the instructions of
Schleicher ASK 21 TN 25 (rudder actuated by hand lever for the front
pilot seat) or TN 30 (rudder control by hand for the rear pilot
seat).
    For reasons described above, this AD requires amendment of the
applicable Schleicher ASK 21 AFM, revising pre-flight checks of the
rudder hand control system.

    You may examine the MCAI on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
9357.

Related Service Information Under 1 CFR Part 51

    Alexander Schleicher GmbH & Co. has issued ASK 21 Technical Note
No. 38, dated May 31, 2016, The service information describes
procedures for inspecting gliders equipped with a rudder hand control
system for proper tension and adjustment if necessary. 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 of this NPRM.

FAA's Determination and Requirements of the Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with this State of Design Authority, they
have notified us of the unsafe condition described in the MCAI and
service information referenced above. We are proposing this AD because
we evaluated all information and determined the unsafe condition exists
and is likely to exist or develop on other products of the same type
design.

Costs of Compliance

    We estimate that this proposed AD will affect 64 products of U.S.
registry. We also estimate that it would take about 2 work-hours per
product to comply with the basic requirements of this proposed AD. The
average labor rate is $85 per work-hour.
    Based on these figures, we estimate the cost of the proposed AD on
U.S. operators to be $10,880, or $170 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 1 work-hour for cost of $85 per product. We have no way of
determining the number of products that may need these actions.

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 proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, 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.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

Alexander Schleicher GmbH & Co.: Docket No. FAA-2016-9382;
Directorate Identifier 2016-CE-032-AD.

(a) Comments Due Date

    We must receive comments by December 27, 2016.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Alexander Schleicher GmbH & Co. ASK 21
gliders, all serial numbers, certificated in any category, that are
modified with a rudder hand control system using either ASK 21
Technical Note No. 25, dated February 16, 1993, or ASK 21 Technical
Note No. 30, dated January 22, 2007.

(d) Subject

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

(e) Reason

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated 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 cable slack in
gliders equipped with a rudder hand control system. We are issuing
this proposed AD to correct any excess slack in the rudder hand
control system, which could result in a short-term blockage of the
rudder control system causing reduced control.

(f) Actions and Compliance

    Unless already done, do the actions in paragraphs (f)(1) through
(3) of this AD:
    (1) If the glider is equipped with a rudder actuated by means of
a hand lever at the left cockpit wall in the front pilot seat by ASK
21 Technical Note (TN) No. 25, dated February 16, 1993, within the
next 60 days after the effective date of this AD, replace the flight
manual (FM) and maintenance manual (MM) pages with the following
pages in ASK 21 TN No. 38, dated May 31, 2016:
    (i) FM: Check List/1, 16a, 19.1a., and 21.
    (ii) MM: 13, 15.
    (2) If the glider is equipped with a rudder actuated by means of
a hand lever at the left cockpit wall in the rear pilot seat by ASK
21 TN No. 30, dated January 22, 2007, within the next 60 days after
the effective date of this AD, replace the FM and MM pages with the
following pages in ASK 21 TN No. 38, dated May 31, 2016:
    (i) FM: Check List/1, 16a, 18a, 19b, 19c, 19.1a, and 21.

    (ii) MM: 13, 15.
    (3) For all affected gliders, within the next 60 days after the
effective date of this AD and repetitively thereafter at intervals
not to exceed every 12 months, inspect the rudder cable tension and
make any necessary corrections following the instructions from FM
page 19.1a, Checking and Adjusting of the Cable Tension, as
specified in ASK 21 TN No. 38, dated May 31, 2016.
    (4) For all affected gliders, after the effective date of this
AD, any glider modified with a rudder hand control system in
accordance with ASK 21 TN No. 25 or TN No. 30 must also amend the FM
and MM following the instructions in ASK 21 TN No. 38, dated May 31,
2016.

(g) Pilot Authorization

    In addition to the provisions of 14 CFR 43.3 and 43.7, the
actions required by paragraph (f)(1) through (2) of this AD may be
performed by the owner/operator (pilot) holding at least a private
pilot certificate and must be entered into the glider records
showing compliance with this AD following 14 CFR 43.9 (a)(1) through
(4) and 14 CFR 91.417(a)(2)(v). The record must be maintained as
required by 14 CFR 91.417, 121.380, or 135.439.

(h) Other FAA AD Provisions

    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: Jim Rutherford, Aerospace Engineer, FAA, Small
Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<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.

(i) Related Information

    Refer to MCAI European Aviation Safety Agency (EASA) AD No.:
2016-0192, dated September 28, 2016, for related information. You
may examine the MCAI on the Internet at http://www.regulations.gov
by searching for and locating Docket No. FAA-2016-9382. For service
information related to this AD, contact Alexander Schleicher GmbH &
Co., Segelflugzeugbau, Germany, Alexander Schleicher Str. 1, D-36163
Poppenhausen (Wasserkuppe), telephone: +49 6658 89-0; fax: +49 6658
89-40; email<EMAIL_ADDRESS>Internet: http://www.alexander-schleicher.de/en/flugzeuge/ask-21/. You may review
this 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.

    Issued in Kansas City, Missouri, on November 2, 2016.
Pat Mullen,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-27041 Filed 11-9-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 109 (Monday, June 8, 2015)]
[Notices]
[Pages 32368-32369]
[FR Doc No: 2015-13902]

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DEPARTMENT OF ENERGY

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Federal Energy Regulatory Commission

[Project No. 14671-000]

Symphony Hydro, LLC; Notice of Preliminary Permit Application
Accepted for Filing and Soliciting Comments, Motions To Intervene, and
Competing Applications

    On March 23, 2015, Symphony Hydro, LLC filed an application for a
preliminary permit under section 4(f) of the Federal Power Act
proposing to study the feasibility of the proposed Symphony Hydro
Project No. 14671-000, to be located at the existing Upper St. Anthony
Lock and Dam on the Mississippi River, near the city of Minneapolis, in
Hennepin County,

Minnesota. The Upper St. Anthony Lock and Dam is owned and operated by
U.S. Army Corps of Engineers. The sole purpose of a preliminary permit,
if issued, is to grant the permit holder priority to file a license
application during the permit term. A preliminary permit does not
authorize the permit holder to perform any land-disturbing activities
or otherwise enter upon lands or waters owned by others without the
owners' express permission.
    The proposed project would be located completely within lands owned
by the United States and consist of: (1) The existing 400-foot-long by
56-foot-wide by 77-foot-high lock (2) two new 56-foot-wide by 70-foot
high vertical lift steel gates; (3) two new submersible 1700-kilowatt
axial flow Kaplan turbine-generator units having a combined capacity of
3.4 megawatts; (4) two new 6-foot-long by 6-foot-wide by 4-foot-high
pad mounted metal boxes containing plant controls, communications and
inverter equipment, and a step-up distribution transformer; (5) a new
400 to 500-foot-long, 13.8 kilovolt, underground transmission line that
would connect to Xcel Energy's distribution system; and (6) appurtenant
facilities. The project would have an estimated annual generation of
18,500 megawatt-hours.
    Applicant Contact: Robert H. Schulte, 2236 Coley Forest Place,
Raleigh, NC 27607,<PHONE_NUMBER>.
    FERC Contact: Tyrone A. Williams,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. The Commission strongly encourages electronic filing.
Please file comments, motions to intervene, notices of intent, and
competing applications using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You
must include your name and contact information at the end of your
comments. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426. The first page of any filing should include
docket number P-14671-000.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-14671) in the docket number field to access
the document. For assistance, contact FERC Online Support.

    Dated: June 2, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-13902 Filed 6-5-15; 8:45 am]
BILLING CODE 6717-01-P