[Federal Register Volume 81, Number 95 (Tuesday, May 17, 2016)]
[Notices]
[Pages 30572-30573]
[FR Doc No: 2016-11704]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a closed meeting on Thursday, May 19,
2016 at 2 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the closed meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or her designee, has
certified that, in her opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (a)(5), (a)(7), (a)(9)(ii) and (10), permit
consideration of the scheduled matter at the closed meeting.
    Commissioner Piwowar, as duty officer, voted to consider the items
listed for the closed meeting in closed session.
    The subject matter of the closed meeting will be:

Institution and settlement of injunctive actions;

Institution and settlement of administrative proceedings;
Resolution of litigation claims;
Formal orders of investigation; and
Other matters relating to enforcement proceedings.

    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact Brent J. Fields from
the Office of the Secretary at<PHONE_NUMBER>.

    Dated: May 12, 2016.
Brent J. Fields,
Secretary.
[FR Doc. 2016-11704 Filed 5-13-16; 4:15 pm]
BILLING CODE 8011-01-P


OECD phase 1A work on a non OECD phase 1A work on a non spawning fish assay spawning fish assay  draft results draft results

Hirofumi Yokota Chemicals Evaluation and Research Institute, Japan ( CERI) Non Non spawning fish assay spawning fish assay

To detect chemicals that affect androgenic or estrogenic activity in fish exposed during a limited part of their lifecycle not including reproduction.

Three core biological endpoints:

 Gross morphology 2nd sex characters and gonado somatic index ( GSI)

 Plasma or liver vitellogenin ( VTG) levels  Histopathology of excised gonads.

Test species  Fathead minnow ( Pimephales promelas)

 Medaka ( Oryzias latipes)

 Zebrafish ( Danio renio) Outline of non spawning fish assay 14 21 Days after initiation of the exposure 0 Daily observation on mortality and abnormal response Separate with mesh barrier Male × 5 Female × 5 Male × 5 Female × 5 Male × 5 Female × 5  Sexual characters  GSI  VTG level  Gonad histology Endpoints

To obtain initial information on:

i) the relevance of the endpoints used in terms of their sensitivity and ( species) specificity ii) the reproducibility of test results.

Participating laboratories  CERI ( Lead laboratory)

 Bayer CropScience AG. ( Germany)

 METOCEAN ENVIRONMENT INC. ( METO) ( Japan)

 National Institute for Environmental Studies ( NIES) ( Japan)

Test substance  17  Estradiol ( E2) ( estrogen)

 17  Trenbolone ( TB) ( androgen)

OECD phase 1A validation study Main endpoint Gross morphology VTG induction Gonad histology Test species Sex GSI 2nd sex characters Male       Fathead minnow Female × ×   Male ×     Medaka Female × ×   Male ×   Zebrafish Female × ND   NA   : Cleary detected in all studies,   : Detected in all studies,   : Detected in a few studies,

× : Not detected ND: Not determined, NA: Not available yet Draft results of the studies with E2 E2 exposure with fathead minnow

Laboratory in charge: CERI, NIES, Bayer

Nominal conc.: 100, 32, 10 ng/ L and control

Number of fish: 10   and 10   / treatment

Age of fish: 8 to 9 month old

Exposure system: flow through exposure

Stock solution: an aqueous solution

Test solution vol.: 10 or 15 L / vessel

Dilution water: dechlorinated tap water or reconstituted water

Test temperature: 25 ± 2

Food: brine shrimp

Chemical analysis: LC MC ( once a week)

VTG analysis: ELISA ( EnBio or Biosense) GSI of male fathead minnow : CERI : NIES : Bayer 0 0.5 1 1.5 2 2.5 3 3.5 Control 10 32 100 E2 nominal concentration ( ng/ L)

GSI (%) CERI NIES Bayer ** 0 0.5 1 1.5 2 2.5 3 3.5 Control 10 32 100 E2 nominal concentration ( ng/ L)

GSI (%) CERI NIES Bayer **

14 day 21 day 0 5 10 15 20 25 30 Control 10 32 100 E2 nominal concentration ( ng/ L)

Number of nuptial tubercles CERI NIES 0 5 10 15 20 25 30 Control 10 32 100 E2 nominal concentration ( ng/ L)

Number of nuptial tubercles CERI NIES * *

**

Secondary sexual characters of male fathead minnow : CERI : NIES 14 day 21 day 0.01 0.1 1 10 100 1000 10000 100000 1000000 Control 10 32 100 E2 nominal concentration ( ng/ L)

VTG conc.

(

 g/

mL blood or plasma) *

* * *

* * * * * *

VTG conc.

(

µ g/

mL)

0.01 0.1 1 10 100 1000 10000 100000 1000000 Control 10 32 100 E2 nominal concentration ( ng/ L)

VTG conc.

(

 g/

mL blood or plasma) * *

* * * * * *

VTG conc.

(

µ g/

mL) VTG of male fathead minnow 14 day 21 day : CERI/ EnBio : NIES/ EnBio : Bayer/ Biosense : NIES/ Biosense ( Blood) ( Blood) ( Blood) ( Plasma)

The plasma sample from several fish was not obtained due to the technical problem. E2 exposure with medaka

Laboratory in charge : CERI, NIES, METO

Nominal conc.: 100, 32, 10 ng/ L and control

Number of fish: 10   and 10   / treatment

Age of fish: 4 to 5 month old

Exposure system: flow through exposure

Stock solution: an aqueous solution

Test solution vol.: 1.8 to 5 L / vessel

Dilution water: dechlorinated tap water

Test temperature: 24 ± 2

Food: brine shrimp ( newly hatched larvae)

Chemical analysis: LC MC ( once a week)

VTG analysis: ELISA ( Transgenic, EnBio or Biosense) 0 0.2 0.4 0.6 0.8 1 1.2 1.4 1.6 Control 10 32 100 E2 nominal concentration ( ng/ L)

GSI (%) 0 0.2 0.4 0.6 0.8 1 1.2 1.4 1.6 Control 10 32 100 E2 nominal concentration ( ng/ L)

GSI (%)

GSI of male medaka 14 day 21 day : CERI : NIES : METO 0 50 100 150 Control 10 32 100 E2 nominal concentration ( ng/ L)

Number of papillary processes CERI NIES METO 0 50 100 150 Control 10 32 100 E2 nominal concentration ( ng/ L)

Number of papillary processes CERI NIES METO * * *

Secondary sexual characters of male medaka 14 day 21 day : CERI : NIES : METO Male Female VTG of male medaka 0.1 1 10 100 1000 10000 100000 Control 10 32 100 E2 nominal concentration ( ng/ L)

VTG conc.

(

ng/

mg liver) CERI/ Trans Genic NIES/ Biosense NIES/ Enbio METO/ Trans Genic * * *

* * *

* * *

* * 0.1 1 10 100 1000 10000 100000 Control 10 32 100 E2 nominal concentration ( ng/ L)

VTG conc.

(

ng/

mg liver) CERI/ Trans Genic NIES/ Biosense NIES/ Enbio METO/ Trans Genic * * * * * *

* *

* * *

: CERI/ Transgenic : NIES/ Biosense : METO/ Transgenic : NIES/ EnBio 14 day 21 day E2 exposure with zebrafish

Laboratory in charge: CERI, NIES, METO, Bayer

Nominal conc.: 100, 32, 10 ng/ L and control

Number of fish: 10   and 10   / treatment

Age of fish: 4 to 6 month old

Exposure system: flow through exposure

Stock solution: an aqueous solution

Test solution vol.: 4.5 to 15 L / vessel

Dilution water: dechlorinated tap water or reconstituted water

Test temperature: 26 ± 2

Food: brine shrimp

Chemical analysis: LC MC ( once a week)

VTG analysis: ELISA ( EnBio or Biosense) 0 0.5 1 1.5 2 2.5 3 3.5 Control 10 32 100 E2 nominal concentration ( ng/ L)

GSI (%) CERI NIES METO Bayer 0 0.5 1 1.5 2 2.5 3 3.5 Control 10 32 100 E2 nominal concentration ( ng/ L)

GSI (%) CERI NIES METO Bayer * *

*

GSI of male zebrafish 14 day 21 day : CERI : NIES : Bayer : METO One male fish in Bayer was identified as female fish after excision of gonads. 0.01 0.1 1 10 100 1000 10000 100000 Control 10 32 100 E2 nominal concentration ( ng/ L)

VTG conc.

(

 g/

mL blood or plasma) CERI/ Enbio NIES/ Enbio NIES/ Biosense METO/ Enbio Bayer/ Biosense * *

* * *

* *

VTG conc.

(

µ g/

mL) 0.01 0.1 1 10 100 1000 10000 100000 Control 10 32 100 E2 nominal concentration ( ng/ L)

VTG conc.

(

 g/

mL blood or plasma) CERI/ Enbio NIES/ Enbio NIES/ Biosense METO/ Enbio Bayer/ Biosense *

* *

* *

VTG conc.

(

µ g/

mL)

VTG of male zebrafish The data from Bayer is not submitted yet.

( Blood) ( Blood) ( Blood) ( Blood) ( Plasma)

: CERI/ EnBio : NIES/ EnBio : Bayer/ Biosense : NIES/ Biosense : METO/ EnBio 14 day 21 day Draft results of the studies with TB Main endpoint Gross morphology VTG reduction Gonad histology Test species Sex GSI 2nd sex characters Male × × × Fathead minnow Female       Male × × × Medaka Female       Male × × Zebrafish Female   ND   NA   : Cleary detected in all studies,   : Detected in all studies,   : Detected in a few studies,

× : Not detected ND: Not determined, NA: Not available yet TB exposure with fathead minnow

Laboratory in charge: CERI, NIES, Bayer

Nominal conc.: 5000, 500, 50 ng/ L and control

Number of fish: 10   and 10   / treatment

Age of fish: 8 to 9 month old

Exposure system: flow through exposure

Stock solution: an aqueous solution

Test solution vol.: 10 or 15 L / vessel

Dilution water: dechlorinated tap water or reconstituted water

Test temperature: 25 ± 2

Food: brine shrimp

Chemical analysis: GC MC ( once a week)

VTG analysis: ELISA ( EnBio or Biosense) : CERI : NIES : Bayer GSI of female fathead minnow 0 5 10 15 20 25 30 Control 50 500 5000 TB nominal concentration ( ng/ L)

GSI (%) 0 5 10 15 20 25 30 Control 50 500 5000 TB nominal concentration ( ng/ L)

GSI (%) *

14 day 21 day 0 2 4 6 8 10 12 14 16 Control 50 500 5000 TB nominal concentration ( ng/ L)

Number of nuptial tubercles 0 2 4 6 8 10 12 14 16 Control 50 500 5000 TB nominal concentration ( ng/ L)

Number of nuptial tubercles Secondary sexual characters of female fathead minnow : CERI : NIES 14 day 21 day VTG of female fathead minnow : CERI/ EnBio : NIES/ EnBio : Bayer/ Biosense : NIES/ Biosense ( Blood) ( Blood) ( Blood) ( Plasma)

14 day 21 day The plasma sample from one fish was not obtained due to the technical problem.

1 10 100 1000 10000 100000 Control 50 500 5000 TB nominal concentration ( ng/ L)

VTG conc.

(

 g/

mL blood or plasma) * * *

* * * *

VTG conc.

(

µ g/

mL) 1 10 100 1000 10000 100000 Control 50 500 5000 TB nominal concentration ( ng/ L)

VTG conc.

(

 g/

mL blood or plasma) *

* * *

* * *

* *

VTG conc.

(

µ g/

mL) TB exposure with medaka

Laboratory in charge : CERI, NIES, METO

Nominal conc.: 5000, 500, 50 ng/ L and control

Number of fish: 10   and 10   / treatment

Age of fish: 4 to 5 month old

Exposure system: flow through exposure

Stock solution: an aqueous solution

Test solution vol.: 1.8 to 5 L / vessel

Dilution water: dechlorinated tap water

Test temperature: 24 ± 2

Food: brine shrimp ( newly hatched larvae)

Chemical analysis: GC MC ( once a week)

VTG analysis: ELISA ( Transgenic, EnBio or Biosense) 0 5 10 15 20 25 Control 50 500 5000 TB nominal concentration ( ng/ L)

GSI (%) 0 5 10 15 20 25 Control 50 500 5000 TB nominal concentration ( ng/ L)

GSI (%) * *

: CERI : NIES : METO GSI of female medaka 14 day 21 day Some females in CERI and METO spawned during the exposure period. Secondary sexual characters of female medaka 0 50 100 150 Control 50 500 5000 TB nominal concentration ( ng/ L)

Number of papillary processes * *

* * * * 0 50 100 150 Control 50 500 5000 TB nominal concentration ( ng/ L)

Number of papillary processes * * * * * *

: CERI : NIES : METO 14 day 21 day 1 10 100 1000 10000 100000 Control 50 500 5000 TB nominal concentration ( ng/ L)

VTG conc.

(

ng/

mg liver) * *

* * 1 10 100 1000 10000 100000 Control 50 500 5000 TB nominal concentration ( ng/ L)

VTG conc.

(

ng/

mg liver) * * *

* *

* *

* * *

VTG of female medaka 14 day 21 day : CERI/ Transgenic : NIES/ Biosense : METO/ Transgenic : NIES/ EnBio TB exposure with zebrafish

Laboratory in charge: CERI, NIES, METO, Bayer

Nominal conc.: 5000, 500, 50 ng/ L and control

Number of fish: 10   and 10   / treatment

Age of fish: 4 to 6 month old

Exposure system: flow through exposure

Stock solution: an aqueous solution

Test solution vol.: 4.5 to 15 L / vessel

Dilution water: dechlorinated tap water or reconstituted water

Test temperature: 26 ± 2

Food: brine shrimp

Chemical analysis: LC MC ( once a week)

VTG analysis: ELISA ( EnBio or Biosense) GSI of female zebrafish 0 5 10 15 20 25 30 35 Control 50 500 5000 TB nominal concentration ( ng/ L)

GSI (%) 0 5 10 15 20 25 30 35 Control 50 500 5000 TB nominal concentration ( ng/ L)

GSI (%) *

14 day 21 day : CERI : NIES : Bayer : METO Each one male fish in CERI and Bayer was identified as female fish after excision of gonads. 0.01 0.1 1 10 100 1000 10000 100000 Control 50 500 5000 TB nominal concentration ( ng/ L)

VTG conc.

(

 g/

mL blood or plasma) * * * *

* *

VTG conc.

(

µ g/

mL)

0.01 0.1 1 10 100 1000 10000 100000 Control 50 500 5000 TB nominal concentration ( ng/ L)

VTG conc.

(

 g/

mL blood or plasma) * *

* *

* *

* *

VTG conc.

(

µ g/

mL) VTG of female zebrafish 14 day 21 day The data from Bayer is not submitted yet.

( Blood) ( Blood) ( Blood) ( Blood) ( Plasma)

: CERI/ EnBio : NIES/ EnBio : Bayer/ Biosense : NIES/ Biosense : METO/ EnBio Draft summary

GSI  Significant differences were not always observed in all studies.

 The values in both intra and inter laboratory varied considerably possibly due to difference in sexual maturity.

 Some female medaka and zebrafish spawned during exposure.

Secondary sexual characters ( fathead minnow and medaka)

 Significant differences were not always observed in all studies.

 The quantification method was not standardized between laboratory.

VTG  Significant differences were observed in all studies.

 The values in both the control and treatment groups differed with the ELISA kits.

 The preparation method of the samples was not standardized. Future plan

All data except for gonadal histology will be submitted to the lead laboratory by August 18th.

The round robin evaluation of gonadal histology will be conducted by several fish pathologists in September.

The draft report will be submitted to OECD by September 1st and then circulated to the members of the OECD FDG.

The final results will be discussed by the OECD FDG meeting which will be held on October 21st and 22nd. Acknowledgement

Bayer CropScience AG.

Chemicals Evaluation and Research Institute, Japan

METOCEAN ENVIRONMENT INC.

National Institute for Environmental Studies

Ms. Anne GOURMELON ( OECD)


[Federal Register Volume 75, Number 127 (Friday, July 2, 2010)]
[Notices]
[Pages 38519-38520]
[FR Doc No: 2010-16173]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9170-8]

Proposed Consent Decree, Clean Air Act Citizen Suit

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Proposed Consent Decree; Request for Public Comment.

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SUMMARY: In accordance with section 113(g) of the Clean Air Act, as
amended (CAA), 42 U.S.C. 7413(g), notice is hereby given of a proposed
consent decree, to address a lawsuit filed by Comite Civico Del Valle,
Inc. in the United States District Court for the Northern District of
California: Comite Civico Del Valle, Inc. v. Jackson, No. 10-cv-00946
PJH (N.D. C.A.). On March 5, 2010, Plaintiff filed a complaint to
compel the U. S. Environmental Protection Agency (EPA or Agency) to
take final action under section 110(k) of the CAA on the ``Imperial
County Air Pollution Control District Rule 420'' (Imperial Rule 420), a
State implementation plan (SIP) revision submitted by the State of
California to EPA on or about August 24, 2007, which pertains to
measures to control particulate matter emissions from beef feedlot
operations within the Imperial Valley. Under the terms of the proposed
consent decree, EPA has agreed to take final action no later than
November 15, 2010.

DATES: Written comments on the proposed consent decree must be received
by August 2, 2010.

ADDRESSES: Submit your comments, identified by Docket ID number EPA-HQ-
OGC-2010-0509, online at http://www.regulations.gov (EPA's preferred
method); by e-mail to<EMAIL_ADDRESS>mailed to EPA Docket Center,
Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001; or by hand delivery or courier to
EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave., NW.,
Washington, DC, between 8:30 a.m. and 4:30 p.m. Monday through Friday,
excluding legal holidays. Comments on a disk or CD-ROM should be
formatted in Word or ASCII file, avoiding the use of special characters
and any form of encryption, and may be mailed to the mailing address
above.

FOR FURTHER INFORMATION CONTACT: Geoffrey L. Wilcox, Air and Radiation
Law Office (2344A), Office of General Counsel, U.S. Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone:<PHONE_NUMBER>; fax number<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Additional Information About the Proposed Consent Decree

    The proposed consent decree establishes a deadline of November 15,
2010, for the Administrator to sign a notice or notices, pursuant to
section 110(k)(2) of the CAA, either approving, disapproving, or
approving in part and disapproving in part, Imperial Rule 420. In
addition, the proposed consent decree requires that following signature
on such notice or notices, EPA shall deliver such notice or notices to
the Office of the Federal Register for publication. The proposed
consent decree also provides that after EPA's completion of the
obligations under the decree, the parties will file a joint request to
the Court to dismiss the litigation with prejudice.
    For a period of thirty (30) days following the date of publication
of this notice, the Agency will accept written comments relating to the
proposed consent decree from persons who were not named as parties or
intervenors to the litigation in question. EPA or the Department of
Justice may withdraw or withhold consent to the proposed consent decree
if the comments disclose facts or considerations that indicate that
such consent is inappropriate, improper, inadequate, or inconsistent
with the requirements of the Act. Unless EPA or the Department of
Justice determines, based on any comment submitted, that consent to
this consent decree should be withdrawn, the terms of the decree will
be affirmed.

II. Additional Information About Commenting on the Proposed Consent
Decree

A. How can I get a copy of the consent decree?

    The official public docket for this action (identified by Docket ID
No. EPA-HQ-OGC-2010-0509) contains a copy of the proposed consent
decree. The official public docket is available for public viewing at
the Office of Environmental Information (OEI) Docket in the EPA Docket
Center, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington,
DC. The EPA Docket Center 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 OEI Docket is<PHONE_NUMBER>.
    An electronic version of the public docket is available through
http://www.regulations.gov. You may use http://www.regulations.gov to
submit or view public comments, access the index listing of the
contents of the official public docket, and to access those documents
in the public docket that are available electronically. Once in the
system, key in the appropriate docket identification number, then
select ``search''.
    It is important to note that EPA's policy is that public comments,
whether submitted electronically or on paper, will be made available
for public viewing online at http://www.regulations.gov without change,
unless the comment contains copyrighted material, CBI, or other
information whose disclosure is restricted by statute. Information
claimed as CBI and other information whose disclosure is restricted by
statute is not included in the official public docket or in the
electronic public docket. EPA's policy is that copyrighted material,
including copyrighted material contained in a public comment, will not
be placed in EPA's electronic public docket but will be available only
in printed, paper form in the official public docket. Although not all
docket materials may be available electronically, you may still access
any of the publicly available docket materials through the EPA Docket
Center.

B. How and to whom do I submit comments?

    You may submit comments as provided in the ADDRESSES section.
Please ensure that your comments are submitted within the specified
comment period. Comments received after the close of the comment period
will be marked ``late.'' EPA is not required to consider these late
comments.
    If you submit an electronic comment, EPA recommends that you
include your name, mailing address, and an e-mail address or other
contact information in the body of your comment and with any disk or
CD-ROM you submit. This ensures that you can be identified as the
submitter of the comment and allows EPA to contact you in case EPA
cannot read your comment due to technical difficulties or needs further
information on the substance of your comment. Any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification,

EPA may not be able to consider your comment.
    Use of the http://www.regulations.gov Web site to submit comments
to EPA electronically is EPA's preferred method for receiving comments.
The electronic public docket system is an ``anonymous access'' system,
which means EPA will not know your identity, e-mail address, or other
contact information unless you provide it in the body of your comment.
In contrast to EPA's electronic public docket, EPA's electronic mail
(e-mail) system is not an ``anonymous access'' system. If you send an
e-mail comment directly to the Docket without going through http://www.regulations.gov, your e-mail address is automatically captured and
included as part of the comment that is placed in the official public
docket, and made available in EPA's electronic public docket.

    Dated: June 28, 2010.
Kevin W. McLean,
Acting Associate General Counsel.
[FR Doc. 2010-16173 Filed 7-1-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 164 (Monday, August 24, 2020)]
[Rules and Regulations]
[Pages 52041-52043]
[FR Doc No: 2020-18614]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 33

[Docket No FAA-2020-0816; Special Conditions No. 33-20-01-SC]

Special Conditions: Safran Helicopter Engines, S.A., Arrano 1A
Turboshaft Engine Model; 30-Minute All Engines Operating Power Rating

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions; request for comments.

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

SUMMARY: These special conditions are issued for the Safran Helicopter
Engines, S.A. (Safran Helicopter Engines), Arrano 1A turboshaft engine
model. This engine model will have a novel or unusual design feature
when compared to the state of technology envisioned in the
airworthiness standards for aircraft engines. This design feature is a
30-minute All Engines Operating (AEO) power rating. The applicable
airworthiness regulations do not contain adequate or appropriate safety
standards for this design feature. These special conditions contain the
additional safety standards that the Administrator considers necessary
to establish a level of safety equivalent to that established by the
existing airworthiness standards.

DATES: This action is effective on Safran Helicopter Engines on August
24, 2020. Send comments on or before October 8, 2020.

ADDRESSES: Send comments identified by docket number FAA-2020-0816
using any of the following methods:
     Federal eRegulations Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30, U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE, Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE, Washington, DC, between 9 a.m., and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: The FAA will post all comments it receives, without
change, to http://regulations.gov/, including any personal information
the commenter provides. Using the search function of the docket
website, anyone can find and read the electronic form of all comments
received into any FAA docket, including the name of the individual
sending the comment (or signing the comment for an association,
business, labor union, etc.). DOT's complete Privacy Act Statement can
be found in the Federal Register published on April 11, 2000 (65 FR
19477-19478).
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE,
Washington, DC, between 9 a.m., and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Tara Fitzgerald, FAA, AIR-6A2, Engine
and Propeller Standards Branch, Aircraft Certification Service, 1200
District Avenue, Burlington, Massachusetts, 01803-5213; telephone (781)
238-7130; facsimile<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The FAA has determined, in accordance with 5
U.S. Code 553(b)(3)(B) and 553(d)(3), that notice and opportunity for
prior public comment are unnecessary because substantially identical
special conditions have been previously subject to the public comment
process in several prior instances such that the FAA is satisfied that
new comments are unlikely. For the same reason, the FAA finds that good
cause exists for adopting these special conditions upon issuance. The
FAA is requesting comments to allow interested persons to submit views
that may not have been submitted in response to the prior opportunities
for comment.

------------------------------------------------------------------------
      Special  conditions  number               Company and model
------------------------------------------------------------------------
No. 33-021-SC \1\.....................  Light Helicopter Turbine Engine
                                         Company CTS800-4AT Turboshaft
                                         Engine.
No. 33-010-SC \2\.....................  Pratt and Whitney Canada, Inc.
                                         PT6C-67E Turboshaft Engine.
No. 33-009-SC \3\.....................  Pratt and Whitney Canada Corp.
                                         PW210S Turboshaft Engine.
------------------------------------------------------------------------
\1\ 82 FR 60854, December 26, 2017.
\2\ 76 FR 56097, September 12, 2011.
\3\ 76 FR 40594, July 11, 2011.

Comments Invited

    The FAA invites interested people to take part in this rulemaking
by sending written comments, data, or views. The most helpful comments
reference a specific portion of the special conditions, explain the
reason for any recommended change, and include supporting data.
    The FAA will consider all comments received by the closing date for
comments. The FAA may change these special conditions based on the
comments received.

Background

    On August 30, 2019, Safran Helicopter Engines applied for a type
certificate for the Arrano 1A turboshaft engine model. The Arrano 1A
turboshaft engine model has an annular inlet integrating inlet guide
vanes, a two-stage centrifugal compressor driven by a single-stage high
pressure turbine, a reverse flow combustion chamber and a single-stage
low pressure turbine (power turbine) driving a reduction gearbox
located at the front of the engine and an exhaust pipe. The Arrano 1A
turboshaft engine model will incorporate a novel or unusual design
feature, which is a 30-minute AEO power rating. Regulations pertaining
to a 30-minute AEO power rating have not been incorporated into part
33. These special conditions provide the requirements for the 30-minute
AEO power rating for the Arrano 1A turboshaft engine model. Safran
Helicopter Engines has requested this 30-minute AEO power rating to
support helicopter search and rescue missions that require hover
operations at high power. The use of the 30-minute AEO power rating
will require special conditions to address the use of this 30-minute
AEO power rating and its effects on the Arrano 1A engine model.

Type Certification Basis

    Under the provisions of title 14, Code of Federal Regulations (14
CFR) 21.17, Safran Helicopter Engines must show that the Arrano 1A
turboshaft engine model meets the applicable provisions of 14 CFR part
33, dated February 1,

1965, as amended by amendments 33-1 through 33-34.
    If the Administrator finds that the applicable airworthiness
regulations (e.g., 14 CFR part 33) do not contain adequate or
appropriate safety standards for the Safran Helicopter Engines, Arrano
1A turboshaft engine model because of a novel or unusual design
feature, special conditions are prescribed under the provisions of
Sec.  21.16.
    Special conditions are initially applicable to the model for which
they are issued. Should the type certificate for that model be amended
later to include any other model that incorporates the same novel or
unusual design feature, these special conditions would also apply to
the other model under Sec.  21.101.
    The FAA issues special conditions, as defined in 14 CFR 11.19, in
accordance with Sec.  11.38, and they become part of the type
certification basis under Sec.  21.17(a)(2).

Novel or Unusual Design Features

    The Arrano 1A turboshaft engine model will incorporate a novel or
unusual design feature, which is a 30-minute AEO power rating. This
rating will be used to support helicopter search and rescue missions
that require hover operations at high power.

Discussion

    The type certification basis for the Arrano 1A turboshaft engine
model does not contain adequate airworthiness standards for a 30-minute
AEO power rating. Therefore, special conditions are necessary to
provide additional safety standards for rating definition, instructions
for continued airworthiness (ICA), and endurance testing.
    The 30-minute AEO power rating is generally intended to be used for
hovering at increased power for search and rescue missions at power
levels higher than the maximum continuous rating, up to rated takeoff
power. These special conditions address the effects on the engine
during the use of the 30-minute AEO power for up to 30 minutes. The 30-
minute AEO power rating time limitation applies to each instance the
30-minute AEO power rating is used. There is no limit to the number of
times the 30-minute AEO power rating can be used during any one flight
and there is no cumulative time limitation.
    In accordance with Sec.  33.4, the applicant must prepare ICAs.
Those ICAs must include instructions to address the unknown usage of
the 30-minute AEO power rating and its effect on engine deterioration
for the Arrano 1A turboshaft engine model. Safran Helicopter Engines
must assess the usage and publish ICAs with airworthiness limitations
section limits in accordance with the usage to prevent excessive engine
deterioration. Because the Arrano 1A turboshaft engine model has a
continuous one engine inoperative (OEI) rating and associated
limitations equal to or higher than the 30-minute AEO rating, the test
time performed at the continuous OEI rating may be credited toward the
25 hours of operation endurance test requirement set forth in these
SCs. However, test times spent at other rating elements of the Sec.
33.87 endurance test, such as takeoff or other OEI ratings (that may be
equal to or higher), may not be counted toward the required 25 hours
endurance test set forth in these SCs. Therefore, special conditions
are issued under the provisions of 14 CFR 11.19, 21.16, and 21.17.
Safran Helicopter Engines must demonstrate compliance to the safety
standards specified in the special conditions.
    These special conditions contain the additional safety standards
that the Administrator considers necessary to establish a level of
safety equivalent to that established by the existing airworthiness
standards.

Applicability

    As discussed above, these special conditions are applicable to the
Safran Helicopter Engines, Arrano 1A turboshaft engine model. Should
Safran Helicopter Engines apply at a later date for a change to the
type certificate to include another model incorporating the same novel
or unusual design feature, these special conditions would apply to that
model as well.

Conclusion

    This action affects only certain novel or unusual design features
on the Arrano 1A turboshaft engine model. It is not a rule of general
applicability.

List of Subjects in 14 CFR Part 33

    Aircraft, Engines, Aviation Safety, Reporting and recordkeeping
requirements.

Authority Citation

    The authority citation for these special conditions is as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type certification basis for the Safran Helicopter Engines, Arrano
1A turboshaft engine model.
    In addition to the general definitions in Sec.  1.1, the following
definition applies to these special conditions: ``Rated 30-minute All
Engines Operating (AEO) power'' means the approved brake horsepower
developed under static conditions at the specified altitude and
temperature, and within the operating limitations under part 33, and
limited in use to periods not exceeding 30 minutes.
    In addition to the airworthiness standards in 14 CFR part 33, the
following special conditions apply:
    (a) Section 33.1, Applicability, and Section 33.3, General. As
applicable, all documentation, testing and analysis required to comply
with the part 33 type certification basis must account for the 30-
minute AEO rating, limits, and usage.
    (b) Section 33.4, Instructions for Continued Airworthiness. In
addition to the requirements of Sec.  33.4, the instructions for
continued airworthiness must:
    (1) Include instructions to ensure that in-service engine
deterioration due to the rated 30-minute AEO power usage will not
exceed that assumed for establishing the engine maintenance program and
all other approved ratings, including one engine inoperative (OEI), are
available (within associated limits and assumed usage) for every
flight.
    (2) Validate the adequacy of the maintenance actions required under
paragraph (b)(1) of these special conditions.
    (3) Include in the airworthiness limitations section any mandatory
inspections and serviceability limits related to the use of the 30-
minute AEO power rating.
    (c) Section 33.7, Engine ratings and operating limitations. In
addition to the ratings and operating limitations required to be
established by Sec.  33.7(a) and (c), a rated 30-minute AEO power and
operating limitations must be established relating to the following:
    (1) Horsepower, torque, shaft speed (r.p.m.) and gas temperature.
    (2) The rated 30-minute AEO power and associated limitations must
not exceed the rated takeoff power and associated limitations.
    (d) Section 33.29, Instrument connection. If dependence is placed
on instrumentation needed to monitor the rating's use, the applicant
must make provision for the installation of that instrumentation,
specify the provisions for instrumentation in the engine installation
instructions, and declare them mandatory in the engine approval
documentation.

    (e) Section 33.87, Endurance Test. In addition to the requirements
of Sec.  33.87(a) and (d), the overall test run must include a minimum
of 25 hours of operation at rated 30-minute AEO power and limits,
divided into periods of not less than 30 minutes, but not more than 60
minutes at rated 30-minute AEO power, and alternate periods at maximum
continuous power or less.
    (1) Each Sec.  33.87(d) continuous OEI rating test period of 60
minutes duration, run at power and limits equal to or higher than the
30-minute AEO power rating, may be credited toward this requirement.
Note that the test time required for the takeoff or other OEI ratings
may not be counted toward the 25 hours of testing required at the 30-
minute AEO power rating.

    Issued in Burlington, Massachusetts, on August 20, 2020.
Robert J. Ganley,
Manager, Engine and Propeller Standards Branch, Aircraft Certification
Service.
[FR Doc. 2020-18614 Filed 8-20-20; 11:15 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 213 (Tuesday, November 3, 2020)]
[Notices]
[Pages 69620-69621]
[FR Doc No: 2020-24275]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL21-13-000]

Californians for Green Nuclear Power, Inc. v. North American
Electric Reliability Corporation, Western Electricity Coordinating
Council, California Independent System Operator Corporation, California
Public Utilities Commission, California State Water Resources Control
Board, and California State Lands Commission; Notice of Complaint

    Take notice that on October 26, 2020, pursuant to the Federal Power
Act, the Natural Gas Act of 1938, the Federal Pipeline Safety
Regulations,\1\ and section 206 of the Rules of Practice and Procedure
of the Federal Energy Regulatory Commission,\2\ Californians for Green
Nuclear Power, Inc. (Complainant) filed a formal complaint against
North American Electric Reliability Corporation, Western Electricity
Coordinating Council, California Independent System Operator
Corporation, California Public Utilities Commission, California State
Water Resources Control Board, and California State Lands Commission,
(Respondent) alleging that, Respondents failed to properly analyze the
bulk electric system and bulk natural gas system consequences in light
of certain California-specific hazards in connection with the approval
of the voluntary plan to close Diablo Canyon Power Plant in 2025, all
as more fully explained in the complaint.
---------------------------------------------------------------------------

    \1\ The Federal Power Act, 16 U.S.C. 791 et seq., the Energy
Policy Act of 2005, 42 U.S.C. 13201 et seq. (2005), the Natural Gas
Act of 1938 15 U.S.C. 717(b) et seq., and Federal Pipeline Safety
Regulations, 49 CFR 192 (2020).
    \2\ 18 CFR 385.206 (2020).
---------------------------------------------------------------------------

    The Complainant certifies that copies of the complaint were served
on the contacts listed for Respondents in the Commission's list of
Corporate Officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to

the proceeding. Any person wishing to become a party must file a notice
of intervention or motion to intervene, as appropriate. The
Respondent's answer and all interventions, or protests must be filed on
or before the comment date. The Respondent's answer, motions to
intervene, and protests must be served on the Complainants.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically may mail
similar pleadings to the Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426. Hand delivered submissions in
docketed proceedings should be delivered to Health and Human Services,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at<EMAIL_ADDRESS>or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on November 16, 2020.

    Dated: October 27, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-24275 Filed 11-2-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 109 (Tuesday, June 7, 2022)]
[Notices]
[Pages 34737-34740]
[FR Doc No: 2022-12171]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-95021; File No. SR-NSCC-2022-007]

Self-Regulatory Organizations; National Securities Clearing
Corporation; Notice of Filing and Immediate Effectiveness of a Proposed
Rule Change To Revise the Voluntary Termination Provisions of the NSCC
Rules for Limited Members

June 1, 2022.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on May 27, 2022, National Securities Clearing Corporation (``NSCC'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II and III below, which
Items have been prepared by the clearing agency. NSCC filed the
proposed rule change pursuant to Section 19(b)(3)(A) \3\ of the Act and
subparagraph (f)(6) \4\ of Rule 19b-4 thereunder. The Commission is
publishing this notice to solicit comments on the proposed rule change
from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    The proposed rule change of NSCC consists of modifications to
NSCC's Rules & Procedures (the ``Rules'') \5\ to revise the voluntary
termination provisions of the Rules in order to provide that a Limited
Member may be deemed to have voluntarily terminated its membership if
NSCC is unable to contact the Limited Member's authorized
representatives, and the Limited Member has not used NSCC's services
for at least 6 months. The proposed changes are described in greater
detail below.
---------------------------------------------------------------------------

    \5\ Capitalized terms not defined herein are defined in the
Rules, available at https://dtcc.com/~/media/Files/Downloads/legal/
rules/nscc_rules.pdf.
---------------------------------------------------------------------------

II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

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

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

1. Purpose
    The proposed rule change consists of modifications to the voluntary
termination provisions of the Rules in order to provide that a Limited
Member may be deemed to have voluntarily terminated its membership if
NSCC is unable to contact an authorized representative of the Limited
Member, as designated by the participant pursuant to Rule 5,\6\ and
there has been no activity in the account by the participant for at
least 6 months. The proposed changes are described in greater detail
below.
---------------------------------------------------------------------------

    \6\ See Rule 5, Section 2, supra note 5, which requires that a
Limited Member appoint a representative that is duly authorized in
the name and on behalf of the Limited Member to sign all
instruments, correct errors and to perform such other duties as may
be required under the Rules and the Procedures and to transact all
business requisite in connection with the operations of NSCC.
---------------------------------------------------------------------------

(i) NSCC Membership Types/Limited Members
    NSCC has several types of membership with different access levels
to services.\7\ Generally, such membership types can be categorized
into ``Members'' which are full-service participants that have access
to NSCC's central counterparty services and ``Limited Members'' whose
access to services is limited to certain services by membership type
specified by NSCC.\8\ The services available for Limited Members are
``non-guaranteed'' services--meaning that NSCC does not act as a
central counterparty or guarantee payments for transactions conducted
through these services.\9\ If a Limited Member using non-guaranteed
services fails to pay for a transaction at settlement, NSCC does not
guarantee the payment and may reverse in whole or in part any credit
previously given to the contra side.\10\ As a result, NSCC bears less
risk for payments relating to non-guaranteed services than it does for
payments relating to its guaranteed services.
---------------------------------------------------------------------------

    \7\ See Rule 2, supra note 5, which describes various NSCC
membership types.
    \8\ Id.
    \9\ See Addendum D of the Rules, supra note 5.
    \10\ See Addendum D of the Rules, supra note 5.
---------------------------------------------------------------------------

(ii) NSCC Termination Provisions
    NSCC has several Rules relating to the termination of a Limited
Member's membership. Those Rules include

provisions that allow NSCC to terminate the membership of a Limited
Member involuntarily (i.e., ``cease to act'') if the Limited Member
violates the Rules or in certain other circumstances listed in the
Rules (``Involuntary Termination Provisions'') \11\ and provisions that
provide that Limited Members can voluntarily terminate their membership
with NSCC. Section 5 of Rule 2B \12\ contains provisions relating to
the voluntary termination of a Limited Member's membership
(collectively, the ``Voluntary Termination Provisions'').\13\ The
Voluntary Termination Provisions generally state that a Limited Member
may terminate its membership by providing NSCC a voluntary termination
notice, and such termination will not be effective until NSCC has
accepted the termination notice. The Voluntary Termination Provisions
provide that NSCC's acceptance shall be evidenced by a notice to NSCC's
participants announcing the Limited Member's termination and the
effective date of the termination.
---------------------------------------------------------------------------

    \11\ See Rules 18 and 46, supra note 5.
    \12\ Section 5 of Rule 2B, supra note 5. Note that although
Settling Bank Only Members are listed as Limited Members (See Rule
2, Section 2(ii), supra note 5), Section 5 of Rule 2B does not apply
to Settling Bank Only Members. See also Rule 2, Section 2, supra
note 5 which states that when the Rules refer to ``Members and
Limited Members'', the reference includes all member types; when
reference is made to ``participants'' in the Rules (as in the
Voluntary Termination Provisions), the reference generally means all
participants other than Settling Bank Only Members, unless the
context makes clear it refers to one or more specific member types.
Section 5 of Rule 2B refers to all Limited Members except for
Settling Bank Only Members. Section 5 of Rule 2B, supra note 5.
    \13\ The Rules also contain voluntary termination provisions
related to a loss allocation withdrawal in Section 6 of Rule 4 that
would not be affected by this proposed rule change. See Section 6 of
Rule 4, supra note 5.
---------------------------------------------------------------------------

(iii) Abandoned/Dormant Accounts
    Neither the Involuntary Termination Provisions nor the Voluntary
Termination Provisions explicitly provide for a situation where a
Limited Member does not provide a voluntary termination notice, stops
using its account, and NSCC is unable to establish communications with
the Limited Member. This could occur for instance if the Limited Member
has gone out of business, merged into another entity and/or liquidated
without notifying NSCC. Although Limited Members are required to notify
NSCC of any material organizational changes and if they no longer meet
continuing membership standards,\14\ NSCC may not know if a Limited
Member has undergone such a change until NSCC has been notified, NSCC
discovers the circumstances due to its ongoing monitoring of its
Limited Members,\15\ or the Limited Member fails to deliver financial
statements or other reports required to be delivered to NSCC
periodically.\16\
---------------------------------------------------------------------------

    \14\ See Section 2.B of Rule 2B, supra note 5.
    \15\ See Section 4 of Rule 2B, supra note 5, which provides that
certain members will be monitored and reviewed on an ongoing and
periodic basis.
    \16\ For instance, Section 2.A of Rule 2B, supra note 5,
requires that a Limited Member provide a Cybersecurity Confirmation
to NSCC every two years. If a Limited Member has gone out of
business and/or liquidated, it would eventually fail to provide its
Cybersecurity Confirmation.
---------------------------------------------------------------------------

    It is likely in such a situation, that the Limited Member would
eventually violate a Rule, such as failing to provide a Cybersecurity
Confirmation \17\ or another ongoing membership requirement, and NSCC
would eventually become aware that the Limited Member has effectively
abandoned the account. For instance, as a result of following up with
Limited Members on the Cybersecurity Confirmation requirement, NSCC has
recently discovered that there are currently Limited Members that have
not used NSCC's services for over 6 months. In addition, NSCC has been
unable to contact the designated authorized representatives of such
Limited Members.
---------------------------------------------------------------------------

    \17\ See Section 2.A of Rule 2B, supra note 5.
---------------------------------------------------------------------------

    NSCC could formally cease to act for such a Limited Member pursuant
to the Involuntary Termination Provisions. If NSCC is unable to reach
the Limited Member, or if NSCC knows that the Limited Member is
unreachable because, for instance, it has gone out of business, NSCC
does not believe that going through the steps of a cease to act, such
as formally notifying the Limited Member with the grounds under
consideration and its right to request a hearing, would be necessary or
appropriate when NSCC has been unable to contact the Limited
Member.\18\ In addition, NSCC uses resources to maintain accounts, such
as monitoring for compliance of the Rules, conducting risk assessments
of Limited Members and updating account documentation. If a Limited
Member has ceased using an account, and NSCC cannot contact the Limited
Member, NSCC would like to avoid continuing to use resources to
maintain the account.
---------------------------------------------------------------------------

    \18\ See Rules 37, 45 and 46, which set forth certain steps to
be taken by the Limited Member and NSCC in a cease to act including
notification and hearing requirements. Rules 37, 45 and 46, supra
note 5.
---------------------------------------------------------------------------

    NSCC is proposing to expand the Voluntary Termination Provisions to
provide that a Limited Member would be deemed to have voluntarily
terminated its membership if NSCC is unable to contact an authorized
representative of the Limited Member, as designated by the Limited
Member pursuant to Rule 5, and there has been no activity in the
account by the Limited Member for at least 6 months. NSCC believes that
in such situations, the Limited Member is effectively abandoning the
account, which is equivalent to affirmatively taking action to close
the account.
(iv) Proposed Rule Changes
    NSCC is proposing to amend each of the Voluntary Termination
Provisions to provide that a Limited Member may be deemed to have
voluntarily terminated its membership if NSCC is unable to contact an
authorized representative of the Limited Member, as designated by the
Limited Member pursuant to Rule 5, and there has been no activity in
the account by the Limited Member for at least 6 months. In addition,
NSCC is proposing to add that any such deemed voluntary termination
shall be effective when NSCC determines that the criteria for a deemed
voluntary termination have been met (i.e., NSCC is unable to contact
the Limited Member and the Limited Member hasn't used its account for
at least 6 months) and that NSCC's determination shall be evidenced by
a notice to NSCC's participants announcing the Limited Member's
termination and the effective date of termination.
(v) Implementation Timeframe
    NSCC would implement the proposed changes no earlier than thirty
(30) days after the date of filing, or such shorter time as the
Commission may designate. As proposed, a legend would be added to Rule
2B stating there are changes that were effective upon filing but have
not yet been implemented. The legend would also state that NSCC would
implement the proposed changes no earlier than thirty (30) days after
the date of filing, or such shorter time as the Commission may
designate. The legend would state that the legend would automatically
be removed upon the implementation of the proposed changes. NSCC would
announce the implementation date of the proposed changes by Important
Notice posted to its website.
2. Statutory Basis
    NSCC believes that the proposal is consistent with the requirements
of the Act and the rules and regulations thereunder applicable to a
registered clearing agency. In particular, NSCC believes that the
proposed rule changes are consistent with Section 17A(b)(3)(F)

of the Act \19\ and Rules 17Ad-22(e)(18) and (e)(23)(i),\20\ each as
promulgated under the Act, for the reasons described below.
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78q-1(b)(3)(F).
    \20\ 17 CFR 240.17Ad-22(e)(18), (e)(23)(i).
---------------------------------------------------------------------------

    Section 17A(b)(3)(F) of the Act requires, in part, that the Rules
be designed to promote the prompt and accurate clearance and settlement
of securities transactions, to assure the safeguarding of securities
and funds which are in the custody or control of NSCC or for which it
is responsible and to remove impediments to and perfect the mechanism
of a national system for the prompt and accurate clearance and
settlement of securities transactions.\21\ The proposed revisions to
the Voluntary Termination Provisions are consistent with Section
17A(b)(3)(F) of the Act because they would provide a clear and
consistent standard relating to how NSCC would treat a Limited Member
that is no longer using the account and that NSCC is unable to contact.
Providing a clear and consistent standard would allow Limited Members
to better understand NSCC's and the Limited Members' rights and
obligations with respect to their membership. NSCC believes that when
Limited Members better understand their rights and obligations
regarding NSCC's clearance and settlement services, they can better act
in accordance with the Rules. NSCC believes that better enabling
Limited Members to comply with the Rules would promote the prompt and
accurate clearance and settlement of securities transactions by NSCC
consistent with Section 17A(b)(3)(F) of the Act.\22\
---------------------------------------------------------------------------

    \21\ Id.
    \22\ Id.
---------------------------------------------------------------------------

    In addition, NSCC believes that treating such a Limited Member as
having voluntarily terminated would make the membership maintenance
process more efficient by allowing NSCC to avoid wasting resources on
maintaining accounts that are no longer used and avoid having to cease
to act in cases where attempting to provide notice to the Limited
Member is pointless and unnecessary. Allowing NSCC to deem such a
Limited Member as having voluntarily terminated would increase
efficiency of the account maintenance process and would free up
resources at NSCC which would leave more resources to ensure the prompt
and accurate clearance and settlement of securities transactions. As
such, NSCC believes the proposed rule changes are consistent with
Section 17A(b)(3)(F) of the Act.\23\
---------------------------------------------------------------------------

    \23\ Id.
---------------------------------------------------------------------------

    Rule 17Ad-22(e)(18) under the Act requires that NSCC establish,
implement, maintain and enforce written policies and procedures
reasonably designed to establish objective, risk based, and publicly
disclosed criteria for participation, which permit fair and open access
by direct and, where relevant, indirect participants and other
financial market utilities, require participants to have sufficient
financial resources and robust operational capacity to meet obligations
arising from participation in the clearing agency, and monitor
compliance with such participation requirements on an ongoing
basis.\24\ NSCC believes that the proposed rule changes have been
designed to meet the applicable provisions of Rule 17Ad-22(e)(18)
because the proposed changes would provide publicly disclosed criteria
relating to how NSCC would treat a Limited Member that is no longer
using the account and that NSCC is unable to contact as having
voluntarily terminated its participation. The proposed rule change
would not adversely affect fair and open access because the deemed
voluntary termination provisions would only be applied to those Limited
Members that have not been using the service and that NSCC has been
unable to contact. Moreover, the deemed voluntary termination
provisions would constitute publicly disclosed requirements for
maintaining participation at NSCC. Therefore, NSCC believes that its
proposal to provide for a deemed voluntary termination is consistent
with Rule 17Ad-22(e)(18) under the Act.\25\
---------------------------------------------------------------------------

    \24\ 17 CFR 240.17Ad-22(e)(18).
    \25\ Id.
---------------------------------------------------------------------------

    Rule 17Ad-22(e)(23)(i) under the Act requires that NSCC establish,
implement, maintain and enforce written policies and procedures
reasonably designed to publicly disclose all relevant rules and
material procedures, including key aspects of its default rules and
procedures.\26\ NSCC believes that the proposed rule changes have been
designed to meet the applicable provisions of Rule 17Ad-22(e)(23)(i)
because the proposed changes would provide publicly disclosed criteria
relating to how NSCC would remove a Limited Member that is no longer
using the account and that NSCC is unable to contact as if such Limited
Member had voluntarily terminated its participation. Therefore, NSCC
believes that its proposal to provide for a deemed voluntary
termination is consistent with Rule 17Ad-22(e)(23)(i) under the
Act.\27\
---------------------------------------------------------------------------

    \26\ 17 CFR 240.17Ad-22(e)(23)(i).
    \27\ Id.
---------------------------------------------------------------------------

(B) Clearing Agency's Statement on Burden on Competition

    NSCC does not believe that the proposed changes relating to the
Voluntary Termination Provisions would have any impact on competition.
These changes would provide a clear and consistent standard for how
NSCC could treat all Limited Members that are no longer using an
account and that NSCC is unable to contact. The proposed changes would
not be adding any obligations on Limited Members that are using NSCC's
services. As such, NSCC believes the proposed rule changes would not
have any impact on competition.

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants, or Others

    NSCC has not received or solicited any written comments relating to
this proposal. If any written comments are received by NSCC, they will
be publicly filed as an Exhibit 2 to this filing, as required by Form
19b-4 and the General Instructions thereto.
    Persons submitting comments are cautioned that, according to
Section IV (Solicitation of Comments) of the Exhibit 1A in the General
Instructions to Form 19b-4, the Commission does not edit personal
identifying information from comment submissions. Commenters should
submit only information that they wish to make available publicly,
including their name, email address, and any other identifying
information.
    All prospective commenters should follow the Commission's
instructions on how to submit comments, available at https://www.sec.gov/regulatory-actions/how-to-submit-comments. General
questions regarding the rule filing process or logistical questions
regarding this filing should be directed to the Main Office of the
Commission's Division of Trading and Markets at
[email protected] or<PHONE_NUMBER>.
    NSCC reserves the right not to respond to any comments received.

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

    Because the foregoing proposed rule change does not:
    (i) significantly affect the protection of investors or the public
interest;

    (ii) impose any significant burden on competition; and
    (iii) become operative for 30 days from the date on which it was
filed, or such shorter time as the Commission may designate, it has
become effective pursuant to Section 19(b)(3)(A) \28\ of the Act and
paragraph (f) of Rule 19b-4(f)(6) thereunder.\29\
---------------------------------------------------------------------------

    \28\ 15 U.S.C 78s(b)(3)(A).
    \29\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-NSCC-2022-007 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NSCC-2022-007. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of NSCC and on DTCC's website
(https://dtcc.com/legal/sec-rule-filings.aspx). All comments received
will be posted without change; the Commission does not edit personal
identifying information from submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NSCC-2022-007 and should be submitted on
or before June 28, 2022.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\30\
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    \30\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-12171 Filed 6-6-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 93 (Friday, May 13, 2016)]
[Notices]
[Pages 29866-29867]
[FR Doc No: 2016-11268]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0880]

Frequently Asked Questions About Medical Foods; Second Edition;
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 we) is announcing the
availability of a guidance for industry entitled ``Frequently Asked
Questions About Medical Foods; Second Edition.'' FDA published earlier
versions of the guidance in May 1997 and May 2007. The second edition
of the guidance provides responses to additional questions regarding
the definition and labeling of medical foods and updates some prior
responses.

DATES: Submit either electronic or written comments on FDA guidances at
any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-D-0880 for ``Frequently Asked Questions About Medical Foods;
Second Edition.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at http://www.regulations.gov or at the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the guidance to Office
of Nutrition and Food Labeling, Center for Food Safety and Applied
Nutrition (HFS-850), Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740. Send two self-addressed adhesive labels
to assist that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Shawne Suggs-Anderson, Center for Food
Safety and Applied Nutrition (HFS-850), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry,
entitled ``Frequently Asked Questions About Medical Foods; Second
Edition.'' We are issuing this guidance consistent with our good
guidance practices regulation

(21 CFR 10.115). The guidance represents the current thinking of FDA on
this topic. 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.
    In the Federal Register of August 13, 2013 (78 FR 49271), we
announced the availability of a draft guidance for industry entitled
``Frequently Asked Questions About Medical Foods; Second Edition.'' We
invited comment on the draft guidance by October 15, 2013. On November
14, 2013, we reopened the comment period giving interested parties an
additional 30 days until December 16, 2013, to submit comments (78 FR
68460).
    This guidance is intended to provide industry with a convenient
place to find answers to frequently asked questions about medical
foods. FDA published earlier versions of the guidance in May 1997 and
May 2007. This guidance is a second edition of the May 2007 guidance
entitled ``Guidance for Industry: Frequently Asked Questions About
Medical Foods.'' The second edition of the guidance provides responses
to additional questions regarding the definition and labeling of
medical foods and updates some of the prior responses. The second
edition also provides FDA's thinking relating to the labeling of
medical foods to be used under supervision by a physician, whether
medical foods can be labeled with ``Rx Only,'' and types of diseases
and conditions that a medical food could be used to manage.
    We received numerous comments on the draft guidance and have
modified the final guidance where appropriate. In addition, we made
editorial changes to improve clarity. The guidance announced in this
notice finalizes the draft guidance dated August 2013.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 101.3, 101.4, 101.5, 101.15, and
101.105 have been approved under OMB control number 0910-0381. The
collection of information under 21 CFR 1, part 1 subpart H has been
approved under OMB control number 0910-0502. The collections of
information in 21 CFR 113.100 and 114.100 (a) through (d) have been
approved under OMB control number 0910-0037.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/FoodGuidances or http://www.regulations.gov.
Use the FDA Web site listed in the previous sentence to find the most
current version of the guidance.

    Dated: May 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-11268 Filed 5-12-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: February 10, 2009 (Volume 74, Number 26)]
[Notices]
[Page 6636-6637]
[DOCID:fr10fe09-79]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2005-E-0423] (formerly Docket No. 2005E-0255)

Determination of Regulatory Review Period for Purposes of Patent
Extension; LUNESTA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for LUNESTA and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims that human drug product.

ADDRESSES: Submit written comments and petitions to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 6222, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Public Law 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the human drug product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human drug product
and continues until FDA grants permission to market

the drug product. Although only a portion of a regulatory review period
may count toward the actual amount of extension that the Director of
Patents and Trademarks may award (for example, half the testing phase
must be subtracted as well as any time that may have occurred before
the patent was issued), FDA's determination of the length of a
regulatory review period for a human drug product will include all of
the testing phase and approval phase as specified in 35 U.S.C.
156(g)(1)(B).
    FDA recently approved for marketing the human drug product, LUNESTA
(eszopiclone). LUNESTA is indicated for the treatment of insomnia.
Subsequent to this approval, the Patent and Trademark Office received a
patent term restoration application for LUNESTA (U.S. Patent No.
6,444,673) from Sepracor, Inc., and the Patent and Trademark Office
requested FDA's assistance in determining this patent's eligibility for
patent term restoration. In a letter dated July 8, 2005, FDA advised
the Patent and Trademark Office that this human drug product had
undergone a regulatory review period and that the approval of LUNESTA
represented the first permitted commercial marketing or use of the
product. Shortly thereafter, the Patent and Trademark Office requested
that FDA determine the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for
LUNESTA is 1,941 days. Of this time, 1,256 days occurred during the
testing phase of the regulatory review period, while 685 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective:
August 25, 1999. The applicant claims August 21, 1999, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was August 25, 1999,
which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the act: January 31,
2003. The applicant claims January 30, 2003, as the date the new drug
application (NDA) for LUNESTA (NDA 21-476) was initially submitted.
However, FDA records indicate that NDA 21-476 was submitted on January
31, 2003.
    3. The date the application was approved: December 15, 2004. FDA
has verified the applicant's claim that NDA 21-476 was approved on
December 15, 2004.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 760 days of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) written or electronic comments and ask for a redetermination
by April 13, 2009. Furthermore, any interested person may petition FDA
for a determination regarding whether the applicant for extension acted
with due diligence during the regulatory review period by August 11,
2009. To meet its burden, the petition must contain sufficient facts to
merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d
sess., pp. 41-42, 1984.) Petitions should be in the format specified in
21 CFR 10.30.
    Comments and petitions should be submitted to the Division of
Dockets Management. Three copies of any mailed information are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Comments and petitions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

    Dated: January 16, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E9-2681 Filed 2-9-09; 8:45 am]

BILLING CODE 4160-01-S