[Federal Register Volume 76, Number 51 (Wednesday, March 16, 2011)]
[Rules and Regulations]
[Page 14279]
[FR Doc No: 2011-6072]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2011-0080]

Drawbridge Operation Regulation; Grassy Sound Channel, Middle
Township, NJ

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Commander, Fifth Coast Guard District, has issued a
temporary deviation from the regulations governing the operation of the
Grassy Sound Channel Bridge across the Grassy Sound Channel, mile 1.0,
at Middle Township, NJ. The deviation is necessary to facilitate the
cleaning and painting of the structure. This deviation allows the
bridge to remain closed for the entirety of the deviation period.

DATES: This deviation is effective from 5 a.m. on March 1, 2011 to 5
p.m. on April 30, 2011.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2011-0080 and are available online
by going to http://www.regulations.gov, inserting USCG-2011-0080 in the
``Keyword'' box and then clicking ``Search''. They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, 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 FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or e-mail Mr. Terrance A. Knowles, Environmental Protection
Specialist, Fifth District; Coast Guard; telephone<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>If you have questions on viewing the
docket, call Renee V. Wright, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Cape May County Bridge Commission
(CMCBC), who owns and operates this bascule drawbridge, has requested a
temporary deviation from the current operating schedule to facilitate
the cleaning and painting of the bridge structure. Under the regular
operating schedule required by 33 CFR 117.721, the draw of the bridge
shall open on signal from 6 a.m. to 8 p.m., from May 15 through
September 30. From 9:15 a.m. to 2:30 p.m. on the fourth Sunday in March
of every year, the draw need not open for vessels. If the fourth Sunday
falls on a religious holiday, the draw need not open from 9:15 a.m. to
2:30 p.m. on the third Sunday of March of every year. Two hours advance
notice is required for all other openings by calling<PHONE_NUMBER>.
    The Grassy Sound Channel Bridge, mile 1.0, in Middle Township NJ,
has a vertical clearance in the closed position of 15 feet above mean
high water. Vessels that can transit under the bridge without an
opening may do so at any time. Under this temporary deviation, CMCBC
will maintain the bridge in the closed position to vessels beginning at
5 a.m. on March 1, 2011 through 5 p.m. on April 30, 2011.
    Historically, in the last two years, the bridge has not opened
during the months of March and April.
    The Coast Guard will inform users of the waterway through our Local
and Broadcast Notices to Mariners of the closure periods for the bridge
so that vessels can arrange their transits to minimize any impact
caused by the temporary deviation.
    The drawbridge will open in the event of an emergency. Vessels that
can pass under the bridge without a bridge opening may do so at all
times. Vessels have an alternate route by transiting through the nearby
Great Channel drawbridge, a detour of approximately two miles.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: March 3, 2011.
Waverly W. Gregory, Jr.,
Chief, Bridge Administration Branch, Fifth Coast Guard District.
[FR Doc. 2011-6072 Filed 3-15-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 82, Number 67 (Monday, April 10, 2017)]
[Proposed Rules]
[Pages 17156-17158]
[FR Doc No: 2017-06961]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0142; Directorate Identifier 2016-SW-013-AD]
RIN 2120-AA64

Airworthiness Directives; Agusta S.p.A.

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
Agusta S.p.A. Model A109S helicopters. This proposed AD is prompted by
a report of a cabin liner detaching from the helicopter and hitting the
main rotor (M/R) blades during flight. This proposed AD would require
adding limitations to the rotorcraft flight manual (RFM). The proposed
actions are intended to prevent an unsafe condition on these products.

DATES: We must receive comments on this proposed AD by June 9, 2017.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0142; or in person at the Docket Operations Office between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the European Aviation Safety Agency (EASA)
AD, the economic evaluation, any comments received, and other
information. The street address for the Docket Operations Office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments will be
available in the AD docket shortly after receipt.
    For service information identified in this proposed rule, contact
AgustaWestland, Product Support Engineering, Via del Gregge, 100, 21015
Lonate Pozzolo (VA) Italy, ATTN: Maurizio D'Angelo; telephone 39-0331-
664757; fax 39 0331-664680; or at http://www.agustawestland.com/technical-bulletins. You may review the referenced service information
at the FAA, Office of the Regional Counsel, Southwest Region, 10101
Hillwood Pkwy, Room 6N-321, Fort Worth, TX 76177.

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

Comments Invited

    We invite you to participate in this rulemaking by submitting
written comments, data, or views. We also invite comments relating to
the economic, environmental, energy, or federalism impacts that might
result from adopting the proposals in this document. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should send only one copy of written comments, or if comments are filed
electronically, commenters should submit only one time.

    We will file in the docket all comments that we receive, as well as
a report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal, we
will consider all comments we receive on or before the closing date for
comments. We will consider comments filed after the comment period has
closed if it is possible to do so without incurring expense or delay.
We may change this proposal in light of the comments we receive.

Discussion

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD No. 2015-0227, dated November 19,
2015, to correct an unsafe condition for AgustaWestland S.p.A. Model
A109S helicopters. EASA advises of a report that the right-hand lower
cabin liner of Internal Arrangement part number (P/N) 109-0814-21-101
detached and hit three main rotor blades during a landing with the
right-hand door removed. EASA states that this condition, if not
corrected, could lead to further occurrences of in-flight lower cabin
liner detachment, possibly resulting in damage to or loss of control of
the helicopter. Therefore, the EASA AD requires revising the RFM to
provide limitations on flights with a passenger cabin sliding door
opened or removed. EASA considers its AD an interim action and states
further AD action may follow.

FAA's Determination

    This helicopter has been approved by the aviation authority of
Italy and is approved for operation in the United States. Pursuant to
our bilateral agreement with Italy, EASA, its technical representative,
has notified us of the unsafe condition described in its AD. We are
proposing this AD because we evaluated all known relevant information
and determined that an unsafe condition is likely to exist or develop
on other helicopters of the same type design.

Related Service Information

    We reviewed AgustaWestland A109S RFM, Document No. 109G0040A013,
Issue 2, Revision 3, dated April 23, 2015, which adds several
limitations regarding flight with a passenger cabin sliding door opened
or removed.

Proposed AD Requirements

    This proposed AD would require, within 15 hours time-in-service,
revising the Limitations section of the RFM by inserting a copy of this
AD or by making pen-and-ink changes to add several limitations:
Prohibiting flight with a passenger cabin sliding door opened or
removed for helicopters with Internal Arrangement P/N 109-0814-21-101
installed; prohibiting flight with a passenger cabin sliding door open
unless modification P/N 109-0814-35 is installed; prohibiting flight
with a passenger cabin sliding door open unless the doors are locked;
establishing a maximum VNE with a passenger cabin sliding
door opened or removed; establishing a maximum airspeed for opening or
closing a passenger cabin sliding door during flight; and prohibiting
instrument flight rule operation with any door opened or removed.

Interim Action

    We consider this proposed AD to be an interim action. The design
approval holder is currently developing a modification that will
address the unsafe condition identified in this AD. Once this
modification is developed, approved, and available, we might consider
additional rulemaking.

Costs of Compliance

    We estimate that this proposed AD would affect 19 helicopters of
U.S. Registry. We estimate that operators may incur the following costs
in order to comply with this AD. At an average labor rate of $85 per
work-hour, revising the RFM would take about 0.5 work-hour, for an
estimated cost of $43 per helicopter, or $817 for the U.S. fleet.

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, 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 to the extent that it justifies making a
regulatory distinction; and (4) Will not have a significant economic
impact, positive or negative, on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

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 airworthiness
directive (AD):

Agusta S.p.A.: Docket No. FAA-2017-0142; Directorate Identifier
2016-SW-013-AD.

(a) Applicability

    This AD applies to Model A109S helicopters, certificated in any
category.

(b) Unsafe Condition

    This AD defines the unsafe condition as detachment of an
internal arrangement lower cabin liner. This condition could result
in damage to a main rotor blade and subsequent loss of control of
the helicopter.

(c) Comments Due Date

    We must receive comments by June 9, 2017.

(d) Compliance

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

(e) Required Actions

    Within 15 hours time-in-service, revise Section 1 Limitations of
the AgustaWestland Model A109S Rotorcraft Flight Manual (RFM) by
inserting a copy of this AD into the RFM or by making pen-and-ink
changes to add the information in Figure 1 to paragraph (e) of this
AD.
[GRAPHIC] [TIFF OMITTED] TP10AP17.000

(f) Credit for Previous Actions

    Incorporating the changes contained in AgustaWestland A109S RFM,
Document No. 109G0040A013, Issue 2, Revision 3, dated April 23,
2015, into Section 1 of the RFM before the effective date of this AD
is considered acceptable for compliance with this AD.

(g) Special Flight Permits

    Special flight permits are prohibited.

(h) Alternative Methods of Compliance (AMOCs)

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

(i) Additional Information

    (1) AgustaWestland A109S RFM Document No. 109G0040A013, Issue 2,
Revision 3, dated April 23, 2015, which is not incorporated by
reference, contains additional information about the subject of this
AD. For service information identified in this AD, contact
AgustaWestland, Product Support Engineering, Via del Gregge, 100,
21015 Lonate Pozzolo (VA) Italy, ATTN: Maurizio D'Angelo; telephone
39-0331-664757; fax 39 0331-664680; or at http://www.agustawestland.com/technical-bulletins. You may review the
referenced service information at the FAA, Office of the Regional
Counsel, Southwest Region, 10101 Hillwood Pkwy, Room 6N-321, Fort
Worth, TX 76177.
    (2) The subject of this AD is addressed in European Aviation
Safety Agency (EASA) AD No. 2015-0227, dated November 19, 2015. You
may view the EASA AD on the Internet at http://www.regulations.gov
in the AD Docket.

(j) Subject

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

    Issued in Fort Worth, Texas, on March 31, 2017.
Scott A. Horn,
Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2017-06961 Filed 4-7-17; 8:45 am]
 BILLING CODE 4910-13-P


Ron Evans/RTP/USEPA/US

03/13/2008 01:19 PM

To

"King, Heidi R."<EMAIL_ADDRESS> cc

Lydia Wegman, Janet Cakir/RTP/USEPA/US@EPA, Tricia Crabtree/RTP/USEPA/US@EPA, darryl weatherhead

Subject

Fw: Chap 5 edits

Heidi, here are our suggested edits in response to your questions.   It seemed easiest to just limit "e" to the basics and send the reader to the appendix.  Please let  me know if this meets your needs.

Changed footnote to this.

"e These estimates do not reflect benefits or costs for the San Joaquin Valley or South Coast Air Basins. Please see Appendix 7b for analysis of these areas"

and made sure the f is next to the $1,900.

Ron Evans/RTP/USEPA/US

03/13/2008 12:51 PM

To

darryl weatherhead

cc

Janet Cakir/RTP/USEPA/US@EPA

Subject

Fw: Chap 5 edits

Can you address by 2:00?

----- Forwarded by Ron Evans/RTP/USEPA/US on 03/13/2008 12:50 PM -----

"King, Heidi R."<EMAIL_ADDRESS> 03/13/2008 12:37 PM

To

Ron Evans/RTP/USEPA/US@EPA, Janet Cakir/RTP/USEPA/US@EPA

cc

Subject

Chap 5 edits

Footnotes in Table 5-1.

Footnote f is there, but I didn't see where the EGU avg annual cost per ton of 1,900 displayed the f superscript to point a reader to the footnote

Footnote e:  Is there  a way to phrase this more clearly?  Second sentence in particular is misleading when it states "costs of these emissions reductions are not incurred as part of meetinga new o3 std"  Don't you mean to say those emissions reductions are not estimated here, rather than not inclurred?   Here is the full FN

"Sacramento Metro, CA geographic area also contains the South Coast and San Joaquin Valley Areas. These two areas will still be reducing emissions to meet the 0.08 ozone standard, and therefore the costs of these emission reductions are not incurred as part of meeting a new ozone standard. The difference between the emission reductions needed in Table 4.7a and this table are accounted for by the tons that South Coast and San Joaquin need to reduce to reach the current standard, and to help Sacramento attain a new ozone standard."


[Federal Register Volume 86, Number 131 (Tuesday, July 13, 2021)]
[Notices]
[Pages 36815-36822]
[FR Doc No: 2021-14791]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-92334; File No. SR-NSCC-2021-007]

Self-Regulatory Organizations; National Securities Clearing
Corporation; Notice of Filing of Proposed Rule Change Relating To
Confidential Information, Market Disruption Events, and Other Changes

July 7, 2021.
    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 June 25, 2021, 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. The Commission is
publishing this notice to solicit comments on the proposed rule change
from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    The proposed rule change consists of modifications to NSCC's Rules
& Procedures (``Rules'') \3\ to (i) revise certain provisions in the
Rules relating to the confidentiality of information furnished by
applicants, Members and Limited Members (collectively,

``participants'') to NSCC, (ii) require that each participant maintain
confidential information furnished by NSCC or its affiliates in
confidence and restrict use and disclosure of such information, (iii)
add certain officers who are allowed to determine that there is a
Market Disruption Event pursuant to Rule 60 and (iv) add a new Rule 60A
to address situations in which it is necessary to disconnect a Member,
Limited Member, third party service provider, or service bureau due to
an imminent threat of harm to NSCC, Members, Limited Members and/or
other market participants. Each of the proposed changes is described in
greater detail below.
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    \3\ Capitalized terms not defined herein are defined in the
Rules, available at https://dtcc.com/~/media/Files/Downloads/legal/
rules/nscc_rules.pdf.
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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 (i) revise
certain provisions in the Rules relating to the confidentiality of
information furnished by participants to NSCC, (ii) require that each
participant maintain confidential information furnished by NSCC or its
affiliates in confidence and restrict use and disclosure of such
information, (iii) add certain officers who are allowed to determine
that there is a Market Disruption Event pursuant to Rule 60 and (iv)
add a new Rule 60A to address situations in which it is necessary to
disconnect a Member, Limited Member, third party service provider, or
service bureau due to an imminent threat of harm to NSCC, Members,
Limited Members and/or other market participants. Each of the proposed
changes is described in greater detail below.
(i) NSCC Confidentiality Requirements
    Section 1.C. of Rule 2A \4\ and Section 3 of Rule 15 \5\ each
contain provisions relating to confidentiality of information furnished
by participants to NSCC (collectively, the ``NSCC Confidentiality
Requirements''). The NSCC Confidentiality Requirements provide that
such furnished information will be held by NSCC in the same degree of
confidence as may be required by law or the rules and regulations of
the appropriate regulatory body having jurisdiction over the
participant. NSCC is proposing to update the NSCC Confidentiality
Requirements because such provisions (i) may result in unequal
treatment of participants due to differing laws or regulations of
regulatory bodies, (ii) may result in a potential conflict of laws
where rules or regulations governing a regulatory body of a participant
differ from the laws applicable to NSCC, or a participant has multiple
regulatory bodies whose rules conflict, (iii) are burdensome as they
require NSCC to track the rules and regulations of each regulatory body
of its participants, and ensure that information provided by
participants to NSCC is held in confidence to the same degree as it is
held by such regulatory bodies and (iv) are unnecessary as NSCC has
sufficient protections in place relating to protection and
confidentiality of participant data.
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    \4\ Section 1.C. of Rule 2A, supra note 3. Rule 2A relates to
initial membership requirements including information that NSCC may
require applicants to furnish to become Members or Limited Members
of NSCC.
    \5\ Section 3 of Rule 15, supra note 3. Rule 15 relates to
assurances of financial responsibility and operational capability
including information that NSCC may require Members or applicants to
furnish.
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    The regulatory bodies that have jurisdiction over participants
differ by participant depending on certain criteria of each
participant, including the type of entity of the participant, where the
participant was organized, the types of businesses in which the
participant engages and where the participant is doing business. In
addition, many participants are regulated by more than one regulatory
body. As a result, a requirement to maintain confidentiality standards
for information provided by a participant based on the regulatory body
or bodies that regulate such participant result in varying standards of
confidentiality for participants that are regulated by different
regulatory bodies. Such varying standards may result in unequal
treatment of participants due to differing laws or regulations of the
regulatory body or bodies governing such participants. In addition,
such varying standards may result in a potential conflict of laws where
rules or regulations governing a regulatory body of a participant
differ from the laws applicable to NSCC or an entity that has multiple
regulatory bodies whose rules conflict.
    NSCC believes that it is unnecessarily burdensome to determine the
rules and regulations of each of the regulatory bodies that regulate
its participants. Such regulatory bodies include numerous U.S. federal
and state regulators as well as foreign national, state and local
regulators. NSCC proposes revising the language in the NSCC
Confidentiality Requirements to maintain one confidentiality standard
for all participants rather than maintaining potentially different
confidentiality standards for participants based on the various,
unrelated regulatory bodies regulating such participants. NSCC is
proposing to replace the existing language in the NSCC Confidentiality
Requirements with language that would provide that NSCC will hold non-
public information furnished pursuant to those Rules in confidence as
may be required under the law or the rules and regulations applicable
to NSCC that relate to the confidentiality of records. Such laws, rules
and regulations would include national, state and foreign laws
governing confidentiality of data that are applicable to NSCC in
connection with its collection and disclosure of data.
    NSCC believes that the rules and regulations applicable to NSCC
governing the use and disclosure of confidential information provide
standards that are representative of those of the various regulatory
bodies governing its participants. As a result, NSCC does not believe
that the proposed rule change relating to the NSCC Confidentiality
Requirements would result in any change to NSCC's practices relating to
data protection and confidentiality of information provided by
participants.
(ii) Participant Confidentiality Requirements
    Historically, NSCC has generally not provided, nor been requested
to provide, information that contains confidential or proprietary
information of NSCC or its affiliates to its participants except for
information necessary for participants and their service providers and
service bureaus to connect to NSCC and to participate in the services
that NSCC offers to its Members and Limited Members. While certain
information is protected by intellectual property rights of NSCC and

its affiliates under applicable intellectual property laws, such as
copyright laws and trademark laws, the Rules do not include any express
obligations for participants to protect confidential information
received by them from NSCC or its affiliates.
    In connection with the development of cyber and information
security programs pursuant to applicable regulatory requirements by
participants, NSCC and its parent company, The Depository Trust &
Clearing Corporation (``DTCC''), have received an increasing number of
requests from participants for confidential and proprietary information
of NSCC and DTCC.\6\ This includes, for example, information regarding
DTCC's network operations and data security practices, legal
settlements, and other information. Additionally, in the event there is
a cyber incident relating to a participant, NSCC or DTCC may be
requested to disclose confidential information regarding its cyber
threat indicators, sources of cyber threat information, or other
information and actions taken related to a cyber event.
---------------------------------------------------------------------------

    \6\ DTCC provides a set of core business processes for NSCC and
DTCC's other subsidiaries, including the technology systems and
networks that provide connectivity between NSCC and its participants
and that provide the ability of NSCC to provide the services as
required under its Rules. Most corporate functions are established
and managed on an enterprise-wide basis pursuant to intercompany
agreements under which it is generally DTCC that provides relevant
services to NSCC and DTCC's other subsidiaries.
---------------------------------------------------------------------------

    In order to provide for contractual protections for such
confidential information of DTCC, NSCC and DTCC's other subsidiaries,
NSCC is proposing to add provisions to the Rules that would require
participants to maintain confidential information of NSCC and its
affiliates that NSCC provides to such participants in confidence and
not to disclose such confidential information except as necessary to
perform such participant's obligations under NSCC's Rules or as
otherwise required by applicable law (``Participant Confidentiality
Requirements''). The Participant Confidentiality Requirements would
provide that in the event of a breach of the Participant
Confidentiality Requirements, NSCC or DTCC would be entitled to seek
any temporary or permanent injunctive or other equitable relief in
addition to any monetary damages under the Rules. In addition, as with
any failure to comply with its Rules, NSCC would have the ability to
impose other disciplinary proceedings or restrictions on access to
services as provided in the Rules for failure to comply with the
Participant Confidentiality Requirements.
(iii) Market Disruption Events
    Rule 60 (Market Disruption and Force Majeure) \7\ (the ``Force
Majeure Rule'') contains provisions that identify the events or
circumstances that would be considered a Market Disruption Event,
including, for example, events that lead to the suspension or
limitation of trading or banking in the markets in which NSCC operates,
or the unavailability or failure of any material payment, bank
transfer, wire or securities settlement systems.\8\ Under the Force
Majeure Rule, during the pendency of a Market Disruption Event, NSCC
would be entitled to (i) suspend the provision of any or all services
and (ii) take, or refrain from taking, or require Members and Limited
Members to take, or refrain from taking, any actions NSCC considers
appropriate to address, alleviate, or mitigate the event and facilitate
the continuation of NSCC's services as may be practicable.\9\
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    \7\ Rule 60, supra note 3.
    \8\ Id.
    \9\ Id.
---------------------------------------------------------------------------

    Section 2 of the Force Majeure Rule provides that the Board of
Directors may determine the existence of a Market Disruption Event and
the actions to be taken in response thereto.\10\ However, if the Board
of Directors is unable to convene, the Force Majeure Rule provides that
certain officers may make such determination, on an interim basis,
which determination is then ratified, modified or rescinded as soon as
practicable by the Board of Directors. The officers that may make such
determination are all senior executive officers of NSCC: Chief
Executive Officer, Chief Financial Officer, Group Chief Risk Officer
and General Counsel.
---------------------------------------------------------------------------

    \10\ Section 2 of Rule 60, id.
---------------------------------------------------------------------------

    The proposed rule change would add two senior executive officers of
NSCC, the Chief Information Officer and the Head of Clearing Agency
Services, to the list of officers that could make such determination if
the Board of Directors is unable to convene. These two officers, like
the other senior executive officers currently listed in the Rules,
maintain senior executive level positions at NSCC, oversee divisions of
NSCC, and hold positions at NSCC that would provide them a necessary
global view into NSCC's operations and systems to enable them to
determine the existence of a Market Disruption Event in the event that
the Board of Directors in unable to convene. Adding these two
additional officers would facilitate NSCC's ability to implement its
emergency procedures in the event of a Market Disruption Event.
(iv) Systems Disconnect: Threat of Significant Impact to NSCC's Systems
    The proposed rule change would add a new Rule 60A (Systems
Disconnect: Threat of Significant Impact to the Corporation's Systems)
(``Systems Disconnect Rule'') that would address situations in which
NSCC determines it is necessary for NSCC to disconnect a single or
limited number of Members, Limited Members, or third party service
providers or service bureaus used by Members or Limited Members to
connect to NSCC \11\ (collectively, ``DTCC Systems Participants'') from
NSCC's systems or network due to an imminent threat of harm to NSCC's
or DTCC's systems. The imminent threat could be the result of a system
disruption or cyber incident applicable to the DTCC Systems
Participants. This would allow DTCC to work with the affected
participants while protecting NSCC, its systems and its other
participants.
---------------------------------------------------------------------------

    \11\ Some Members and Limited Members use third parties to
connect to NSCC's systems and/or to send data to NSCC and receive
data from NSCC on the Member's or Limited Member's behalf. Such
third parties are referred to as ``service providers'' or ``service
bureaus'' herein.
---------------------------------------------------------------------------

    The proposed Systems Disconnect Rule would be structured similarly
to the Force Majeure Rule. The Systems Disconnect Rule would address
NSCC's authority to take certain actions upon the occurrence, and
during the pendency, of a Major Event. A ``Major Event'' would be
defined as the happening of one or more Systems Disruption(s) (as
defined below) that is reasonably likely to have a significant impact
on NSCC's operations, including the DTCC Systems (as defined below),
that affect the business, operations, safeguarding of securities or
funds, or physical functions of NSCC, Members, Limited Members, and/or
other market participants. ``Systems Disruption'' would be defined as
the unavailability, failure, malfunction, overload, or restriction
(whether partial or total) of a DTCC Systems Participant's systems that
disrupts or degrades the normal operation of such DTCC Systems
Participant's systems; or anything that impacts or alters the normal
communication or the files that are received, or information
transmitted, to or from the DTCC Systems. ``DTCC Systems'' would be
defined as the systems, equipment and technology networks of DTCC, NSCC
and/or their Affiliates,\12\ whether owned, leased, or licensed,
software, devices, IP addresses

or other addresses or accounts used in connection with providing the
services set forth in the Rules, or used to transact business or to
manage the connection with NSCC.
---------------------------------------------------------------------------

    \12\ Affiliate is defined in Rule 1 and is intended to cover
DTCC and DTCC's other subsidiaries that use shared systems with
NSCC. Rule 1, supra note 3. See description of the shared systems of
DTCC, NSCC and DTCC's other subsidiaries, supra note 6.
---------------------------------------------------------------------------

    The proposed Systems Disconnect Rule would allow NSCC to mitigate
the effect of such events by facilitating the continuity of services
(or, if deemed necessary, the temporary suspension of services). To
that end, under the proposed Systems Disconnect Rule, NSCC would be
entitled, during the pendency of a Major Event, to (1) disconnect a
DTCC Systems Participant's systems from the DTCC Systems, (2) suspend
the receipt and/or transmission of files or communications to or from
the DTCC Systems Participant to the DTCC Systems and/or (3) take, or
refrain from taking, or require a DTCC Systems Participant to take or
refrain from taking, any actions that NSCC considers appropriate to
prevent, address, correct, mitigate or alleviate the Major Event and
facilitate the continuation of services as may be practicable and, in
that context, issue instructions to the DTCC Systems Participant.
    The proposed Systems Disconnect Rule would define the governance
procedures for how NSCC would determine whether, and how, to implement
the provisions of the rule. A determination that a Major Event has
occurred could be made by the same officers with delegated authority
under the Force Majeure Rule as discussed above (an ``Officer Major
Event Action''). Following this determination, any management committee
on which all of the foregoing officers serve would convene, and NSCC
would convene a Board of Directors meeting as soon as practicable
thereafter, and in any event within five Business Days following such
determination, in each case, to ratify, modify, or rescind the Officer
Major Event Action. The proposed Systems Disconnect Rule would require
Members and Limited Members to notify NSCC immediately upon becoming
aware of a Major Event, and, likewise, would require NSCC to promptly
notify the DTCC Systems Participant(s) of any action NSCC takes or
intends to take with respect to such DTCC Systems Participant(s)
pursuant to the proposed rule.
    Finally, the Systems Disconnect Rule would address certain
miscellaneous matters including: (i) A limitation of liability for any
failure or delay in performance, in whole or in part of NSCC's
obligations under the Rules, arising out of or related to a Major
Event, (ii) a statement that the power of NSCC to take any action
pursuant to the Systems Disconnect Rule also includes the power to
repeal, rescind, revoke, amend or vary such action, (iii) a statement
that the powers of NSCC pursuant to the Systems Disconnect Rule shall
be in addition to and not in derogation of, authority granted elsewhere
in the Rules to take action as specified therein, (iv) a requirement
that Members and Limited Members shall keep any DTCC Confidential
Information (as defined below) provided to them by NSCC and/or in
connection with a Major Event confidential and (v) a statement that in
the event of any conflict between the provisions of the Systems
Disconnect Rule and any other Rules or Procedures, the provisions of
the Systems Disconnect Rule would prevail.
(v) Proposed Rule Changes
    The proposed rule change would amend the Rules to make the
following changes to implement the changes discussed above:
NSCC Confidentiality Requirements Changes
    The proposed rule change would amend the NSCC Confidentiality
Requirements in Section 1.C. of Rule 2A \13\ and Section 3 of Rule 15
\14\ to state as follows:

    \13\ Section 1.C. of Rule 2A, supra note 3.
    \14\ Section 3 of Rule 15, supra note 3.
---------------------------------------------------------------------------

    Any non-public information furnished to the Corporation pursuant to
this Rule shall be held in confidence as may be required under the
laws, rules and regulations applicable to the Corporation that relate
to the confidentiality of records.

    As discussed above, the proposed language is intended to provide
one standard that NSCC would apply uniformly to all participants, which
assures participants that such information would be held in confidence
with appropriate controls. NSCC would add ``non-public'' when
describing the information that is subject to the NSCC Confidentiality
Requirements to make it clear that such requirements would only apply
to information that is not public in both Section 1.C. of Rule 2A and
Section 3 of Rule 15. NSCC would also amend a sentence in Addendum L
that references the NSCC Confidentiality Requirements set forth in Rule
15 to reflect the proposed updated language.
    Section 1.C. of Rule 2A would also include language relating to
Participant Confidentiality Requirements as described below.
Participant Confidentiality Requirements
    In order to provide for Participant Confidentiality Requirements,
NSCC would add provisions in Section 1.C. of Rule 2A \15\ (with respect
to applicants) and a new Section 5 of Rule 2B \16\ (with respect to
Members and Limited Members) to state that each participant shall
maintain DTCC Confidential Information in confidence to the same extent
and using the same means it uses to protect its own confidential
information, but no less than a reasonable standard of care, and shall
not use DTCC Confidential Information or disclose DTCC Confidential
Information to any third party except as necessary to perform its
obligations under the Rules or as otherwise required by applicable law.
NSCC would add a new definition of DTCC Confidential Information in
Rule 1 \17\ to provide that ``DTCC Confidential Information'' would
mean all non-public information provided by DTCC and/or NSCC that (i)
is marked or otherwise identified in writing prior to disclosure to the
recipient as confidential, (ii) is designated by DTCC or NSCC as
confidential, or (iii) the recipient knows or, under the circumstances
surrounding disclosure, ought to reasonably know is confidential. NSCC
would also add a definition of DTCC in Rule 1 and remove a
corresponding definition in Rule 42 \18\ since it would be defined in
Rule 1.
---------------------------------------------------------------------------

    \15\ Section 1.C. of Rule 2A, supra note 3.
    \16\ Rule 2B, supra note 3.
    \17\ Rule 1, supra note 3.
    \18\ Rule 42, supra note 3.
---------------------------------------------------------------------------

    NSCC would also add a statement in each provision relating to
Participant Confidentiality Requirements that each participant
acknowledges that a breach of its confidentiality obligations under the
Rules may result in serious and irreparable harm to NSCC and/or DTCC
for which there is no adequate remedy at law. In the event of such a
breach by the participant, NSCC and/or DTCC would be entitled to seek
any temporary or permanent injunctive or other equitable relief in
addition to any monetary damages. In addition, NSCC would re-number the
existing Section 5 of Rule 2B to Section 6 to reflect the addition of
the new Section 5.
Force Majeure Rule Officer Additions
    The proposed rule change would add the Chief Information Officer
and the Head of Clearing Agency Services to the list of officers that
could make a determination of a Market Disruption

Event if the Board of Directors is unable to convene in Rule 60.\19\
---------------------------------------------------------------------------

    \19\ Rule 60, supra note 3.
---------------------------------------------------------------------------

Systems Disconnect Rule
    The proposed rule change would add a new Rule 60A entitled
``Systems Disconnect: Threat of Significant Impact to the Corporation's
Systems'' that would address situations in which NSCC determines it is
necessary for NSCC to disconnect a DTCC Systems Participant or DTCC
Systems Participants from NSCC's systems or network due to an imminent
threat of harm to NSCC's or DTCC's systems consistent with the
description above. The proposed Systems Disconnect Rule would include
new definitions for ``DTCC Systems,'' ``DTCC Systems Participant,''
``Major Event'' and ``Systems Disruption'' consistent with the
descriptions of the Systems Disconnect Rule above.
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 each of
the proposed rule changes is consistent with Section 17A(b)(3)(F) of
the Act,\20\ and Rules 17Ad-22(e)(1) and (e)(21) \21\ promulgated under
the Act. In addition, NSCC believes that the proposed changes to add
the two senior executive officers in the Force Majeure Rule and to add
the proposed Systems Disconnect Rule are consistent with Rules 17Ad-
22(e)(2) and (e)(17) under the Act.\22\
---------------------------------------------------------------------------

    \20\ 15 U.S.C. 78q-1(b)(3)(F).
    \21\ 17 CFR 240.17Ad-22(e)(1) and (e)(21).
    \22\ 17 CFR 240.17Ad-22(e)(2) and (e)(17).
---------------------------------------------------------------------------

Section 17A(b)(3)(F)
    Section 17A(b)(3)(F) of the Act \23\ 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.
---------------------------------------------------------------------------

    \23\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    NSCC believes that the proposed changes revising the NSCC
Confidentiality Requirements and adding the Participant Confidentiality
Requirements are each consistent with this provision of the Act. The
proposed revisions to the NSCC Confidentiality Requirements are
consistent with this provision because the proposed revisions would
provide a clear and consistent standard relating to how NSCC holds the
information furnished by participants pursuant to Rule 2A \24\ and Rule
15.\25\ The confidential information that NSCC receives pursuant to
Rule 2A and Rule 15 is used by NSCC to determine whether to admit a
participant as a Member or Limited Member, to continue to allow such
participant to be a Member or Limited Member, or to better understand
the risks relating to each participant. Providing a clear and
consistent standard would facilitate this process by allowing
participants to better understand NSCC's obligations with respect to
such information and providing a uniform obligation for NSCC with
respect to such information. NSCC believes that facilitating the
ability of NSCC to evaluate participants would promote the prompt and
accurate clearance and settlement of securities transactions by NSCC.
As such, NSCC believes the proposed rule changes are consistent with
Section 17A(b)(3)(F) of the Act.\26\
---------------------------------------------------------------------------

    \24\ Rule 2A, supra note 3.
    \25\ Rule 15, supra note 3.
    \26\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    NSCC also believes that the proposed rule change adding the
Participant Confidentiality Requirements is consistent with this
provision of the Act because the proposed revisions to the Participant
Confidentiality Requirements would provide a clear and consistent
contractual obligation for participants who are requesting confidential
information from NSCC. Having clear and consistent Rules would help
participants to better understand their rights and obligations
regarding NSCC's clearance and settlement services. The information
requested by participants that would be subject to the Participant
Confidentiality Requirements would be used by participants to determine
whether to participate in NSCC's services, NSCC system requirements and
NSCC system safeguards. NSCC believes that when Members and 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 Members and Limited
Members to comply with the Rules would promote the prompt and accurate
clearance and settlement of securities transactions by NSCC. As such,
NSCC believes the proposed rule changes are consistent with Section
17A(b)(3)(F) of the Act.\27\
---------------------------------------------------------------------------

    \27\ Id.
---------------------------------------------------------------------------

    NSCC believes that the proposed changes to add the two officers to
make a determination of a Market Disruption Event and to add the
Systems Disconnect Rule are also consistent with this provision of the
Act because those changes would enhance and streamline NSCC's ability
to take necessary actions in the event of a Market Disruption Event or
a Major Event. Improving the ability of NSCC to react to a Market
Disruption Event or a Major Event would allow NSCC to protect its
participants and their ability to promptly and accurately clear and
settle securities transactions, and allow NSCC to safeguard securities
and funds that are in its custody or control. In particular, allowing
two additional officers that are able to make an interim determination
of a Market Disruption Event in the event that the Board of Directors
is unable to convene would add additional flexibility and tools to NSCC
while maintaining proper risk controls and improve the ability of NSCC
to act in the event of a Market Disruption Event. Also, providing for
the ability of NSCC to disconnect DTCC Systems Participants, suspend
the receipt or transmission of files or communications to or from a
DTCC Systems Participant, and/or require the DTCC Systems Participant
to take such other actions as are necessary to protect NSCC and its
participants would, in each case, provide additional tools for NSCC in
the event of a Major Event.
    Improving the governance around the determination of a Market
Disruption Event, and the implementation of procedures allowing NSCC to
disconnect a DTCC Systems Participant or DTCC Systems Participants from
NSCC's systems or network due to an imminent threat of harm, would
improve NSCC's ability to address and minimize losses to NSCC and its
participants. Risks, threats and potential vulnerabilities due to a
Market Disruption Event or a Major Event could impact NSCC's ability to
clear and settle securities transactions, or to safeguard the
securities and funds which are in its custody or control or for which
it is responsible. In addition, providing governance around the ability
to disconnect a DTCC Systems Participant that is having a systems
disruption that could disrupt the ability of NSCC or other DTCC Systems
Participants from using NSCC's systems would remove impediments to and
perfect the mechanism of a national system for the prompt and accurate
clearance and settlement of securities transactions. Although
disconnecting or limiting the service of a DTCC Systems Participant

in the event of a Major Event would likely be an impediment to such
DTCC Systems Participant, improving NSCC's ability to address and
minimize losses to NSCC and its participants, and reducing risks,
threats and potential vulnerabilities due to a Major Event that could
impact NSCC's ability to clear and settle securities transactions, or
to safeguard the securities and funds which are in its custody or
control or for which it is responsible, would be consistent with
Section 17A(b)(3)(F) of the Act.\28\
---------------------------------------------------------------------------

    \28\ Id.
---------------------------------------------------------------------------

    Therefore, by implementing tools that would help to mitigate these
risks, NSCC believes that the proposed rule change would promote the
prompt and accurate clearance and settlement of securities
transactions, assure the safeguarding of securities and funds which are
in the custody or control of NSCC or for which it is responsible, and
remove impediments to and perfect the mechanism of a national system
for the prompt and accurate clearance and settlement of securities
transactions, consistent with the requirements of Section 17A(b)(3)(F)
of the Act.\29\
---------------------------------------------------------------------------

    \29\ Id.
---------------------------------------------------------------------------

Rule 17Ad-22(e)(1)
    In addition, the proposed rule change is designed to be consistent
with Rule 17Ad-22(e)(1) promulgated under the Act,\30\ which requires
NSCC to establish, implement, maintain and enforce written policies and
procedures reasonably designed to provide for a well-founded, clear,
transparent and enforceable legal basis for each aspect of its
activities in all relevant jurisdictions.
---------------------------------------------------------------------------

    \30\ 17 CFR 240.17Ad-22(e)(1).
---------------------------------------------------------------------------

    Establishing clear and consistent rules for each participant with
respect to the NSCC Confidentiality Requirements would allow NSCC to
maintain one confidentiality standard for all participants rather than
maintaining potentially different confidentiality standards for
participants based on the various, unrelated regulatory bodies
governing such participants. In addition, setting forth a clear
contractual obligation relating to Participant Confidentiality
Requirements would enhance the understanding of the participants
receiving information from NSCC and allow NSCC to treat participants
equally with respect to how the information furnished to participants
should be protected by the participants.
    Adding the two officers to make a determination of a Market
Disruption Event and adding the Systems Disconnect Rule are also
consistent with Rule 17Ad-22(e)(1) under the Act because those changes
would describe the circumstances under which NSCC could take actions in
the event of a Market Disruption Event or a Major Event that are
necessary to protect NSCC and its participants. Providing clear
guidelines with respect to Market Disruption Events and Major Events
would allow participants to understand the rights and obligations of
the participants in the event of a Market Disruption Event or a Major
Event.
    Therefore, by establishing uniform and clear standards with respect
to its receipt and furnishing of confidential information, and by
providing clear rights and obligations of NSCC and its participants
with respect to Market Disruption Events and Major Events, NSCC
believes that the proposed rule change is consistent with the
requirements of Rule 17Ad-22(e)(1) promulgated under the Act.\31\
---------------------------------------------------------------------------

    \31\ Id.
---------------------------------------------------------------------------

Rule 17Ad-22(e)(21)
    In addition, the proposed rule change is designed to be consistent
with Rule 17Ad-22(e)(21) promulgated under the Act,\32\ which requires
NSCC to, inter alia, establish, implement, maintain and enforce written
policies and procedures reasonably designed to be efficient and
effective in meeting the requirements of its participants and the
markets it serves. The proposed rule change would streamline the NSCC
Confidentiality Requirements by providing that NSCC would apply one
standard for all participants relating to confidential information sent
to NSCC by participants, which would enhance (i) efficiency by avoiding
applying varying standards of confidentiality based on the rules and
regulations of the varying regulatory bodies that regulate the
participants, and (ii) effectiveness by reducing potential conflicts of
laws and providing equal treatment to participants relating to such
confidential information.
---------------------------------------------------------------------------

    \32\ 17 CFR 240.17Ad-22(e)(21).
---------------------------------------------------------------------------

    The addition of the Participant Confidentiality Requirements would
also provide a uniform and easily discernable requirement for all
participants with respect to confidential information provided by NSCC
allowing NSCC to provide necessary information to such participants in
a safe and efficient manner. Adding two additional officers that are
able to make an interim determination of a Market Disruption Event in
the event that the Board of Directors is unable to convene would add
additional flexibility and tools to NSCC while maintaining proper risk
controls and improve the ability of NSCC to act quickly, efficiently
and effectively in a Market Disruption Event to address and minimize
losses. Also, providing for the ability of NSCC to disconnect DTCC
Systems Participants, suspend the receipt or transmission of files or
communications to or from a DTCC Systems Participant, and/or require
the DTCC Systems Participant to take such other actions as are
necessary to protect NSCC and its participants would, in each case,
provide additional tools for NSCC in the event of a Major Event and
improve NSCC's ability to act quickly, efficiently and effectively in
the event of a Major Event to address and minimize losses.
    Therefore, by establishing a more efficient and effective process
for the treatment of confidential language, and establishing procedures
designed to improve NSCC's ability to act quickly, efficiently and
effectively in the event of a Market Disruption Event and a Major
Event, NSCC believes that the proposed rule change is consistent with
the requirements of Rule 17Ad-22(e)(21) promulgated under the Act.\33\
---------------------------------------------------------------------------

    \33\ Id.
---------------------------------------------------------------------------

Rule 17Ad-22(e)(2)
    In addition, the proposed rule change is designed to be consistent
with Rule 17Ad-22(e)(2) promulgated under the Act,\34\ which requires
NSCC to, inter alia, establish, implement, maintain and enforce written
policies and procedures reasonably designed to provide for governance
arrangements that are clear and transparent and that specify clear and
direct lines of responsibility.
---------------------------------------------------------------------------

    \34\ 17 CFR 240.17Ad-22(e)(2).
---------------------------------------------------------------------------

    Adding two additional officers that are able to make an interim
determination of a Market Disruption Event in the event that the Board
of Directors is unable to convene would add additional flexibility and
tools to NSCC while maintaining proper risk controls, and improve the
ability of NSCC to act quickly, efficiently and effectively in a Market
Disruption Event and mitigate any impact from such Market Disruption
Event. Adding these officers to the governance procedures relating to a
determination of a Market Disruption Event would make such governance
procedures clear and transparent, and specify clear and direct lines of
responsibility with respect to the determination of a Market Disruption
Event, consistent with Rule 17Ad-22(e)(2) under the Act.\35\
---------------------------------------------------------------------------

    \35\ Id.
---------------------------------------------------------------------------

    Adding the governance procedures relating to making a determination
of a Major Event in the Systems Disconnect

Rule is also consistent with Rule 17Ad-22(e)(2) promulgated under the
Act.\36\ Identifying the officers that have the ability to determine if
there is a Major Event, and providing for the ability of any management
committee on which all of such officers serve and the Board of
Directors to ratify, modify or rescind any determination of a Major
Event by an officer would make such governance procedures clear and
transparent, and specify clear and direct lines of responsibility with
respect to the determination of a Major Event, consistent with Rule
17Ad-22(e)(2).\37\
---------------------------------------------------------------------------

    \36\ Id.
    \37\ Id.
---------------------------------------------------------------------------

Rule 17Ad-22(e)(17)
    In addition, the proposed rule change is designed to be consistent
with Rule 17Ad-22(e)(17)(i) promulgated under the Act,\38\ which
requires NSCC to establish, implement, maintain and enforce written
policies and procedures reasonably designed to manage the covered
clearing agency's operational risks by identifying the plausible
sources of operational risk, both internal and external, and mitigating
their impact through the use of appropriate systems, policies,
procedures, and controls.
---------------------------------------------------------------------------

    \38\ 17 CFR 240.17Ad-22(e)(17)(i).
---------------------------------------------------------------------------

    Adding two additional officers that are able to make an interim
determination of a Market Disruption Event in the event that the Board
of Directors is unable to convene would add additional flexibility and
tools to NSCC while maintaining proper risk controls and improve the
ability of NSCC to act quickly, efficiently and effectively in a Market
Disruption Event and mitigate any impact from such Market Disruption
Event. Also, providing for the ability of NSCC to disconnect DTCC
Systems Participants, suspend the receipt or transmission of files or
communications to or from a DTCC Systems Participant, and/or require
the DTCC Systems Participant to take such other actions as are
necessary to protect NSCC and its participants would, in each case,
provide additional tools for NSCC in the event of a Major Event and
improve NSCC's ability to act quickly, efficiently and effectively in
the event of a Major Event and mitigate any impact from such Major
Event.
    Therefore, by providing clear, efficient procedures of NSCC and its
participants with respect to Market Disruption Events and Major Events
that help identify and mitigate operational risks, NSCC believes that
the proposed rule change is consistent with the requirements of Rule
17Ad-22(e)(17)(i) promulgated under the Act.\39\
---------------------------------------------------------------------------

    \39\ Id.
---------------------------------------------------------------------------

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

    NSCC does not believe that the proposed changes relating to the
NSCC Confidentiality Requirements would have any impact on competition.
These changes would provide one standard for how NSCC treats
participant information furnished subject to the NSCC Confidentiality
Requirements but would not affect the information that the participants
are required to provide or affect the manner in which the participants
must provide the information. As such, NSCC believes these proposed
rule changes would not have any impact on competition.
    NSCC does not believe the proposed changes relating to adding
Participant Confidentiality Requirements would have any impact on
competition. Although the addition of the Participant Confidentiality
Requirements would be adding obligations on participants with respect
to how they treat confidential or proprietary information of NSCC or
its affiliates, such obligations would be minimal because NSCC would
only require that such participants hold such confidential information
using the same means they use to protect their own confidential
information but not less than a reasonable standard of care. The use of
this standard would protect NSCC by providing a clear legal obligation
to protect such information but would not be burdensome or expensive
for participants, and therefore NSCC believes that it would not have
any impact on competition.
    NSCC does not believe the changes relating to adding the two
officers to make a determination of a Market Disruption Event would
have any impact on competition. The proposed rule change would add two
senior executive officers of NSCC, the Chief Information Officer and
the Head of Clearing Agency Services, to the list of officers that
could make a determination of a Market Disruption Event if the Board of
Directors is unable to convene. Such addition would provide additional
officers who could determine whether there is a Market Disruption Event
but would not otherwise affect the rights of Members or Limited Members
or NSCC in the determination of a Market Disruption Event or if a
Market Disruption Event is declared. Therefore, NSCC does not believe
that the addition of the two officers would have any impact on
competition.
    NSCC does not believe that the changes relating to adding the
Systems Disconnect Rule would have any impact, or impose any burden, on
competition not necessary or appropriate in furtherance of the purposes
of the Act.\40\ To the extent that NSCC determines that there is a
Major Event, it could take or refrain from taking actions, or require
participants to take or refrain from taking actions, that could burden
competition because such requirements could cause participants to incur
additional costs, allow NSCC to suspend services or communications, or
disconnect a DTCC Systems Participant from the DTCC Systems. NSCC
believes such burden on competition could be significant but would be
both necessary and appropriate in furtherance of the purposes of the
Act, as permitted by Section 17A(b)(3)(I) of the Act,\41\ for the
reasons described below.
---------------------------------------------------------------------------

    \40\ 15 U.S.C. 78q-1(b)(3)(I).
    \41\ Id.
---------------------------------------------------------------------------

    NSCC believes that the proposed changes to add the Systems
Disconnect Rule are necessary in furtherance of the purposes of Section
17A(b)(3)(F) of the Act,\42\ and Rules 17Ad-22(e)(1), (e)(2), (e)(17)
and (e)(21) promulgated under the Act.\43\ The proposed changes to add
the Systems Disconnect Rule would (i) improve the ability of NSCC to
react to a Major Event allowing NSCC to protect itself and its
participants and their ability to promptly and accurately clear and
settle securities transactions, and allow NSCC to safeguard securities
and funds that are in its custody or control, consistent with the
requirements of Section 17A(b)(3)(F) of the Act,\44\ (ii) provide clear
guidelines with respect to Major Events that would allow participants
to understand the rights and obligations of the participants and NSCC
in the event of a Major Event, consistent with Rule 17Ad-22(e)(1)
promulgated under the Act,\45\ (iii) identify the officers that have
the ability to determine if there is a Major Event, and provide for the
ability of any management committee on which all of such officers
serve, and the Board of Directors, to ratify, modify or rescind any
determination of a Major Event by an officer, which would make such
governance procedures clear and transparent, and specify clear and
direct lines of responsibility with respect to the determination of a
Major Event, consistent with Rule 17Ad 22(e)(2)

promulgated under the Act,\46\ (iv) improve the ability of NSCC to act
quickly, efficiently and effectively in the event of a Major Event, and
mitigate any impact from such event by providing clear, efficient
procedures of NSCC and its participants with respect to such event,
consistent with the requirements of Rule 17Ad-22(e)(17)(i) promulgated
under the Act \47\ and (v) establish procedures designed to improve
NSCC's ability to act quickly, efficiently and effectively in the event
of a Major Event, consistent with the requirements of Rule 17Ad-
22(e)(21) promulgated under the Act.\48\
---------------------------------------------------------------------------

    \42\ 15 U.S.C. 78q-1(b)(3)(F).
    \43\ 17 CFR 240.17Ad-22(e)(1), (e)(2), (e)(17) and (e)(21).
    \44\ 15 U.S.C. 78q-1(b)(3)(F).
    \45\ 17 CFR 240.17Ad-22(e)(1).
    \46\ 17 CFR 240.17Ad-22(e)(2).
    \47\ 17 CFR 240.17Ad-22(e)(17)(i).
    \48\ 17 CFR 240.17Ad-22(e)(21).
---------------------------------------------------------------------------

    In addition, NSCC believes that the proposed changes to add the
Systems Disconnect Rule are appropriate in furtherance of the Act. Such
changes have been designed to improve the ability of NSCC to act
quickly, efficiently and effectively in the event of a Major Event, and
mitigate any impact from such event while also providing the Members
and Limited Members clear guidelines with respect to such event to
allow participants to understand their rights and obligations. Such
changes have also been designed to apply uniformly to all Members and
Limited Members in the event of a Major Event and should not affect
NSCC's day-to-day operations under normal circumstances, or in the
management of a typical Member or Limited Member default scenario or
non-default event.
    Therefore, NSCC does not believe that the proposed rule change
would impose any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act.\49\
---------------------------------------------------------------------------

    \49\ 15 U.S.C. 78q-1(b)(3)(I).
---------------------------------------------------------------------------

(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. NSCC will notify the Commission of any written comments
received by NSCC.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NSCC-2021-007 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-2021-007. 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
(http://dtcc.com/legal/sec-rule-filings.aspx). All comments received
will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NSCC-2021-007 and should be submitted on
or before August 3, 2021.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\50\
---------------------------------------------------------------------------

    \50\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-14791 Filed 7-12-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: April 30, 2010 (Volume 75, Number 83)]
[Notices]
[Page 22812]
[DOCID:fr30ap10-90]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0035]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
on How to Submit a Notice of Intent to Slaughter for Human Food
Purposes in Electronic Format to the Center for Veterinary Medicine

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by June 1,
2010.

ADDRESSES:  To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or e-mailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0450.
Also include the FDA docket number found in brackets in the heading of
this document

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Guidance for Industry on How to Submit a Notice of Intent to Slaughter
for Human Food Purposes in Electronic Format to The Center for
Veterinary Medicine--(OMB Control Number 0910-0450)--Extension

    Section 512(j) of the Federal Food, Drug, and Cosmetic Act (the
act), gives FDA the authority to set conditions under which animals
treated with investigational new animal drugs may be marketed for food
use. Under this authority, FDA's Center for Veterinary Medicine (CVM)
issues to a new animal drug sponsor (sponsor) a slaughter authorization
letter that sets the terms under which animals treated with
investigational new animal drugs may be slaughtered. The U.S.
Department of Agriculture (USDA), also monitors the slaughter of
animals treated with investigational new animal drugs under the
authority of the Meat Inspection Act (21 U.S.C. 601-95). Sponsors must
submit slaughter notices each time animals treated with investigational
new animal drugs are presented for slaughter, unless this requirement
is waived by an authorization letter (21 CFR 511.1(b)(5) and 9 CFR
309.17). These notifications assist CVM and USDA in monitoring the
safety of the food supply. Slaughter notices were previously submitted
to CVM and USDA in paper format. CVM's guidance on ``How to Submit a
Notice of Intent to Slaughter for Human Food Purposes in Electronic
Format to the Center for Veterinary Medicine'' provides sponsors with
the option of submitting a slaughter notice to CVM and USDA via the
Internet as an e-mail attachment. The electronic submission of
slaughter notices is part of CVM's ongoing initiative to provide a
method for paperless submission. The likely respondents are new animal
drug sponsors.
    In the Federal Register of February 5, 2010 (75 FR 6034), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
  Section of the
  act/  FDA Form       Number of       Annual Frequency     Total Annual        Hours per         Total Hours
      Number          Respondents        of Responses       Responses\2\         Response
----------------------------------------------------------------------------------------------------------------
512j/3488                         40                0.4                 16                .08                1.3
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Electronic submissions received between January 1, 2008, and December 31, 2008.

    The number of respondents in table 1 of this document is the number
of sponsors registered to make electronic submissions (40). The number
of total annual responses are based on a review of the actual number of
submissions made between January 1, 2008, and December 31, 2008.
Sixteen total annual responses times .08 hours per response = 1.3 total
hours.
    Submitting a slaughter notice electronically represents an
alternative to submitting a notice on paper of intent to slaughter. The
reporting burden for compilation and submission on paper of this
information is included in OMB clearance of the information collection
provisions of 21 CFR 511.1 (OMB number 0910-0450). The estimates in
table 1 of this document reflect the burden associated with putting the
same information on FDA Form 3488, and resulted from previous
discussions with sponsors about the time necessary to complete this
form.

    Dated: April 27, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-10084 Filed 4-29-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 86, Number 123 (Wednesday, June 30, 2021)]
[Notices]
[Pages 34767-34768]
[FR Doc No: 2021-13976]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-E-2192; FDA-2020-E-2194; FDA-2020-E-2195]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for OXBRYTA and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by August 30, 2021.
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 December 27, 2021. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before August 30, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 30, 2021. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

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 Nos.
FDA-2020-E-2192; FDA-2020-E-2194; and FDA-2020-E-2195, for
``Determination of Regulatory Review Period for Purposes of Patent
Extension; OXBRYTA.'' Received comments, those filed in a timely manner
(see ADDRESSES), 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 Sec.  10.20 (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>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 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 drug 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 USPTO 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 has approved for marketing the human drug product, OXBRYTA
(voxelotor) indicated for the treatment of sickle cell disease in
adults and pediatric patients 12 years of age and older. Subsequent to
this approval, the USPTO received patent term restoration applications
for OXBRYTA (U.S. Patent Nos. 9,018,210, 10,017,491, and 10,034,879)
from Global Blood Therapeutics, Inc., and the USPTO requested FDA's
assistance in determining the patents' eligibility for patent term
restoration. In a letter dated December 14, 2020, FDA advised the USPTO
that this human drug product had undergone a regulatory review period
and that the approval of OXBRYTA represented the first permitted
commercial marketing or use of the product. Thereafter, the USPTO
requested that FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
OXBRYTA is 1,847 days. Of this time, 1,694 days occurred during the
testing phase of the regulatory review period, while 153 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 (FD&C Act) (21 U.S.C. 355(i)) became effective:
November 6, 2014. FDA has verified the applicant's claims that the date
the investigational new drug application became effective was on
November 6, 2014.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: June 26,
2019. FDA has verified the applicant's claims that the new drug
application (NDA) for OXBRYTA (NDA 213137) was initially submitted on
June 26, 2019.
    3. The date the application was approved: November 25, 2019. FDA
has verified the applicant's claims that NDA 213137 was approved on
November 25, 2019.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 318 days, 329 days, or 332 days of patent term
extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (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.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: June 23, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13976 Filed 6-29-21; 8:45 am]
BILLING CODE 4164-01-P


Ron Evans/RTP/USEPA/US

09/26/2008 01:56 PM

To

"King, Heidi R."<EMAIL_ADDRESS> cc

Brian Heninger/DC/USEPA/US@epa, Charlotte Bertrand/DC/USEPA/US@epa, Charles Fulcher/RTP/USEPA/US@EPA, Darryl Weatherhead/RTP/USEPA/US@epa, Kathy Kaufman/RTP/USEPA/US@epa, <EMAIL_ADDRESS><EMAIL_ADDRESS>Al McGartland<EMAIL_ADDRESS>Tricia Crabtree/RTP/USEPA/US@EPA, Lydia Wegman, rosalina rodriguez, <EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS> Subject

Fw: cost per ton by measure - All Measures, no cut point

Here is the Excel spreadsheet with the cost per ton data per your request.   We are having server issues, let me know if this does not come thru with the attachment

----- Forwarded by Ron Evans/RTP/USEPA/US on 09/26/2008 01:52 PM -----

Darryl Weatherhead/RTP/USEPA/US

09/26/2008 12:59 PM

To

Evans.Ron@epamail.epa.gov@EPA

cc

Kathy Kaufman/RTP/USEPA/US@EPA, Tom Walton/RTP/USEPA/US@EPA, Fulcher.Charles@epamail.epa.gov@EPA

Subject

cost per ton by measure - All Measures, no cut point


[Federal Register Volume 77, Number 13 (Friday, January 20, 2012)]
[Notices]
[Pages 2974-2975]
[FR Doc No: 2012-1077]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2246-058]

Yuba County Water Agency; Notice of Proposed Restricted Service
List for a Programmatic Agreement for Managing Properties Included in
or Eligible for Inclusion in the National Register of Historic Places

    Rule 2010 of the Federal Energy Regulatory Commission's
(Commission) Rules of Practice and Procedure provides that, to
eliminate unnecessary expense or improve administrative efficiency, the
Secretary may establish a restricted service list for a particular
phase or issue in a proceeding.\1\ The restricted service list should
contain the names of persons on the service list who, in the judgment
of the decisional authority establishing the list, are active
participants with respect to the phase or issue in the proceeding for
which the list is established.
---------------------------------------------------------------------------

    \1\ 18 CFR section 385.2010.
---------------------------------------------------------------------------

    The Commission staff is consulting with the California State
Historic Preservation Officer (hereinafter, California SHPO), and the
Advisory Council on Historic Preservation (hereinafter, Council)
pursuant to the Council's regulations, 36 CFR part 800, implementing
section 106 of the National Historic Preservation Act, as amended, (16
U.S.C. section 470 f), to prepare and execute a programmatic agreement
for managing properties included in, or eligible for inclusion in, the
National Register of Historic Places at the Yuba River Project No.
2246.
    The programmatic agreement, when executed by the Commission and the
California SHPO, would satisfy the Commission's section 106
responsibilities for all individual undertakings carried out in
accordance with the license until the license expires or is terminated
(36 CFR 800.13[e]). The Commission's responsibilities pursuant to
section 106 for the Yuba River Project would be fulfilled through the
programmatic agreement, which the Commission proposes to draft in
consultation with certain parties listed below. The executed
programmatic agreement would be incorporated into any Order issuing a
license.
    Yuba County Water Agency, as licensee for the Yuba River Project
No. 2246, and the United Indian Auburn Indian Community, Nevada City
Rancheria, Strawberry Valley Rancheria, Enterprise Rancheria, Mooretown
Rancheria, Greenville Rancheria,

Washoe Tribe, Mechoopda Maidu Indians, Tsi-Akim Maidu Tribe, Tahoe and
Plumas National Forest have expressed an interest in this preceding and
are invited to participate in consultations to develop the programmatic
agreement.
    For purposes of commenting on the programmatic agreement, we
propose to restrict the service list for the aforementioned project as
follows:

John Eddins or Representative, Office of Planning and Review, Advisory
Council on Historic Preservation, 1100 Pennsylvania Ave. NW., Suite
809, Washington, DC 20004
Carrie Smith or Representative, Tahoe National Forest, 9646 Donner Pass
Road, Truckee, CA 96161
Cathy Bishop or Representative, Strawberry Valley Rancheria, 1540
Strader Avenue, Sacramento, CA 95815
Virginia Covert or Representative, Nevada City Rancheria, P.O. Box 825,
Nevada City, CA 95959
Guy Taylor or Representative, Mooretown Rancheria of Maidu Indians, 31
Alverde Drive, Oroville, CA 95966
Ren Reynolds or Representative, Butte Tribal Council, Enterprise
Rancheria, 1693 Mt. Ida Road, Oroville, CA 95966
Crista Steward or Representative, Greenville Rancheria, P.O. Box 279,
Greenville, CA 95947
Marcos Guerrero or Representative, United Auburn Indian Community of
the Auburn Rancheria, 10720 Indian Hill Road, Auburn, CA 95603
Darrel Cruz or Representative, Washoe Tribe of Nevada and California,
919 US Highway 395 South, Gardnerville, NV 89410
Dan Elliot or Representative, Plumas National Forest, 159 Lawrence
Street/P.O. Box 11500, Quincy, CA 95971
Grayson Coney or Representative, Tsi-Akim Maidu Tribe, P.O. Box 1316,
Colfax, CA 95713
Mike DeSpain or Representative, Mechoopda Maidu Indians, 125 Mission
Ranch Blvd., Chico, CA 95926
Amanda Blosser or Representative, Office of Historic Preservation,
Department of Parks and Recreation, 1725 23rd Street, Suite 100,
Sacramento, CA 95816-7100
Geoff Rabone or Representative, Yuba County Water Agency, 1220 F
Street, Marysville, CA 95901

    Any person on the official service list for the above-captioned
proceeding may request inclusion on the restricted service list, or may
request that a restricted service list not be established, by filing a
motion to that effect within 15 days of this notice date. In a request
for inclusion, please identify the reason(s) why there is an interest
to be included. Also please identify any concerns about historic
properties, including Traditional Cultural Properties. If historic
properties are to be identified within the motion, please use a
separate page, and label it NON-PUBLIC Information.
    Any such motions may be filed electronically via the Internet. See
18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site (http://www.ferc.gov/docs-filing/ferconline.asp) under the
``eFiling'' link. For a simpler method of submitting text only
comments, click on ``Quick Comment.'' For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>call toll-free at
(866) 208-3676; or, for TTY, contact<PHONE_NUMBER>. Although the
Commission strongly encourages electronic filing, documents may also be
paper-filed. To paper-file, mail an original and seven copies to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street NE., Washington, DC 20426. Please put the project number
(P-2246-005) on the first page of the filing.
    If no such motions are filed, the restricted service list will be
effective at the end of the 15 day period. Otherwise, a further notice
will be issued ruling on any motion or motions filed within the 15 day
period.

    Dated: January 12, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-1077 Filed 1-19-12; 8:45 am]
BILLING CODE 6717-01-P