[Federal Register: December 31, 2009 (Volume 74, Number 250)]
[Rules and Regulations]
[Page 69262-69264]
[DOCID:fr31de09-7]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-0412; Directorate Identifier 2009-NM-022-AD;
Amendment 39-16154; AD 2009-26-15]
RIN 2120-AA64

Airworthiness Directives; Empresa Brasileira de Aeronautica S.A.
(EMBRAER) Model ERJ 170 Airplanes, and Model ERJ 190-100 LR, -100 IGW,
-100 STD, -200 STD, -200 LR, and -200 IGW Airplanes

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

ACTION: Final rule.

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

    It has been found the possibility of some aluminum fasteners
having been installed instead of titanium ones at bulkhead 1 of the
LH (left-hand) and RH (right-hand) pylons of some [Embraer ERJ 170
and] Embraer ERJ 190 aircraft models. * * *
* * * * *
The unsafe condition for Model 170 airplanes is structural damage in
the case of bird impact in the region of bulkhead 1 of the pylons,
which could adversely affect continued safe flight and landing. The
unsafe condition for Model 190 airplanes is damage to the hydraulic
lines and electrical generator power cables in the case of bird impact
in the region of bulkhead 1 of the pylons, which might lead to presence
of fire without indication to the flightcrew. We are issuing this AD to
require actions to correct the unsafe condition on these products.

DATES: This AD becomes effective February 4, 2010.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of February 4,
2010.

ADDRESSES: You may examine the AD docket on the Internet at http://
www.regulations.gov or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Kenny Kaulia, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-2848; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on May 5, 2009 (74 FR
20659). That NPRM proposed to correct an unsafe condition for the
specified products. The mandatory continuing airworthiness information
(MCAI) 2008-10-04 states:

    It has been found the possibility of some aluminum fasteners
having been installed instead of titanium ones at bulkhead 1 of the
LH and RH pylons of some Embraer ERJ 170 aircraft models. The
structural integrity of the region where these fasteners are
installed may be affected in case of bird impact.
* * * * *
    MCAI 2008-09-02 states:
    It has been found the possibility of some aluminum fasteners
having been installed instead of titanium ones at bulkhead 1 of the
LH (left-hand) and RH (right-hand) pylons of some Embraer ERJ 190
aircraft models. In the case of a bird strike in the pylon bulkhead
1 equipped with aluminum fasteners there is the possibility where
the impact may affect some equipments installed in the region after
the bulkhead 1. Damages to the hydraulic lines and electrical
generator power cables may lead to presence of fire in the region,
without indication to the flight crew.
* * * * *
The unsafe condition for Model 170 airplanes is structural damage in
the case of bird impact in the region of bulkhead 1 of the pylons,
which could adversely affect continued safe flight and landing. The
unsafe condition for Model 190 airplanes is damage to the hydraulic
lines and electrical generator power cables in the case of bird impact
in the region of bulkhead 1 of the pylons, which might lead to presence
of fire without indication to the flightcrew. Corrective actions
include inspecting for the presence of aluminum fasteners at pylon
bulkhead 1, and replacing all aluminum fasteners with titanium
fasteners. You may obtain further information by examining the MCAI in
the AD docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comment received from Embraer, the
manufacturer.

Support for AD on Model ERJ 190 Airplanes

    Embraer supports the AD on Model ERJ 190 airplanes due to the
system design characteristics of that model. Embraer states that a bird
strike could lead to hydraulic fluid leakage associated with damage to
the electrical generator power cables, a situation that would be
favorable to fire in a section of the airplane that is not equipped
with fire detection or suppression systems.

Request To Exclude Model ERJ 170 Airplanes

    Embraer does not agree that an unsafe condition exists for Model
ERJ 170 airplanes. Embraer states that, unlike Model ERJ 190 airplanes,
Model ERJ 170 airplanes do not have hydraulic system or electrical
generator power cables passing through the pylon forward position,
where the aluminum fasteners were installed. The fuel system is
installed behind two reinforced structural frames. Embraer states that
in the event of a bird strike, the fuel system would unlikely be
reached by any part of a bird with sufficient energy to cause any
damage. Embraer states that this situation is extremely improbable.
    From this comment we infer that Embraer is requesting that we
remove Model ERJ 170 airplanes from the applicability of the NPRM. We
do not agree. The subject unsafe condition exists for the affected
Model ERJ 170 airplanes. We consulted with the issuer of the MCAI,
Ag[ecirc]ncia Nacional de Avia[ccedil][atilde]o Civil (ANAC). ANAC
states that the structure in this region does not have sufficient
residual strength for continued safe flight in case of bird impact. We
concur with ANAC that an unsafe condition exists for the affected ERJ
170 aircraft models due to the aluminum fasteners installed in the
subject area. The purpose of this AD is to ensure that the affected
structure has sufficient residual strength for continued safe flight
and landing of the airplane following a bird strike, which the
manufacturer has not demonstrated. We have not changed the AD in this
regard. However, we have clarified the unsafe condition for the Model
ERJ 170 airplanes in the Summary, Discussion, and paragraph (e) of this
AD.

Request To Exclude Model ERJ 190-ECJ Airplanes

    Embraer requests that we remove Model ERJ 190-ECJ airplanes from
the applicability of the NPRM because the model is not included in the
effectivity of Embraer Service Bulletin 190-54-0008, dated December 21,
2007.
    We agree to remove Model ERJ 190-ECJ from the applicability of this
AD. We have confirmed with the manufacturer that this model does not
have aluminum fasteners installed in the subject location. Therefore,
we have removed that model from paragraph (c) of this AD.

Conclusion

    We reviewed the available data, including the comment received, and
determined that air safety and the public interest require adopting the
AD with the change described previously. We determined that this change
will not increase the economic burden on any operator or increase the
scope of the AD.

Differences Between This AD and the MCAI or Service Information

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

Costs of Compliance

    We estimate that this AD will affect 20 products of U.S. registry.
We also estimate that it will take about 2 work-hours per product to
comply with the basic requirements of this AD. The average labor rate
is $80 per work-hour. Based on these figures, we estimate the cost of
this AD to the U.S. operators to be $3,200, or $160 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Operations office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2009-26-15 Empresa Brasileira de Aeronautica S.A. (EMBRAER):
Amendment 39-16154. Docket No. FAA-2009-0412; Directorate Identifier
2009-NM-022-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective February
4, 2010.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to EMBRAER Model ERJ 170-100 LR, -100 STD, -
100 SE, -100 SU, -200 LR, -200 STD, and -200 SU airplanes,
certificated in any category, serial numbers 17000156 through
17000169 inclusive; and Model ERJ 190-100 LR, -100 IGW, -100 STD, -
200 STD, -200 LR, and -200 IGW airplanes, certificated in any
category, serial numbers 19000047 through 19000089 inclusive.

Subject

    (d) Air Transport Association (ATA) of America Code 54:
Nacelles/Pylons.

Reason

    (e) Brazilian Airworthiness Directive 2008-09-02, effective
September 30, 2008, states:

    It has been found the possibility of some aluminum fasteners
having been installed instead of titanium ones at bulkhead 1 of the
LH (left-hand) and RH (right-hand) pylons of some Embraer ERJ 190
aircraft models. In the case of a bird strike in the pylon bulkhead
1 equipped with aluminum fasteners there is the possibility where
the impact may affect some equipments installed in the region after
the bulkhead 1. Damages to the hydraulic lines and electrical
generator power cables may lead to presence of fire in the region,
without indication to the flight crew.
* * * * *
Brazilian Airworthiness Directive 2008-10-04, effective November 10,
2008, states:

    It has been found the possibility of some aluminum fasteners
having been installed instead of titanium ones at bulkhead 1 of the
LH and RH pylons of some Embraer ERJ 170 aircraft models. The
structural integrity of the region where these fasteners are
installed may be affected in case of bird impact.
* * * * *
The unsafe condition for Model 170 airplanes is structural damage in
the case of bird impact in the region of bulkhead 1 of the pylons,
which could adversely affect continued safe flight and landing. The
unsafe condition for Model 190 airplanes is damage to the hydraulic
lines and electrical generator power cables in the case of bird
impact in the region of bulkhead 1 of the pylons, which might lead
to presence of fire without indication to the flight crew.
Corrective actions include inspecting for the presence of aluminum
fasteners at pylon bulkhead 1, and replacing all aluminum fasteners
with titanium fasteners.

Actions and Compliance

    (f) Unless already done, do the following actions.
    (1) Within 5,000 flight cycles after the effective date of this
AD: Inspect the fasteners in bulkhead 1 of the left- and right-hand
pylons for the presence of aluminum fasteners, in accordance with
Part I of the Accomplishment Instructions of Embraer Service
Bulletin 170-54-0007 or 190-54-0008, both dated December 21, 2007;
as applicable. If no aluminum fastener is found, this AD requires no
further action.
    (2) If any aluminum fastener is found, before further flight
after the inspection required by paragraph (f)(1) of this AD:
Replace any aluminum fastener with a titanium fastener in accordance
with Part II of the Accomplishment Instructions of Embraer Service
Bulletin 170-54-0007 or 190-54-0008, both dated December 21, 2007;
as applicable.

FAA AD Differences

    Note 1: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. Send information to ATTN:
Kenny Kaulia, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your principal maintenance inspector (PMI) or
principal avionics inspector (PAI), as appropriate, or lacking a
principal inspector, your local Flight Standards District Office.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.), the Office of Management and Budget (OMB) has
approved the information collection requirements and has assigned
OMB Control Number 2120-0056.

Related Information

    (h) Refer to MCAI Brazilian Airworthiness Directive 2008-09-02,
effective September 30, 2008; MCAI Brazilian Airworthiness Directive
2008-10-04, effective November 10, 2008; and Embraer Service
Bulletins 170-54-0007 and 190-54-0008, both dated December 21, 2007;
for related information.

Material Incorporated by Reference

    (i) You must use Embraer Service Bulletin 170-54-0007, dated
December 21, 2007; or Embraer Service Bulletin 190-54-0008, dated
December 21, 2007; as applicable; to do the actions required by this
AD, unless the AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Empresa Brasileira de Aeronautica S.A. (EMBRAER), Technical
Publications Section (PC 060), Av. Brigadeiro Faria Lima, 2170--
Putim--12227-901 S[atilde]o Jose dos Campos--SP--BRASIL; telephone:
+55 12 3927-5852 or +55 12 3309-0732; fax: +55 12 3927-7546; e-mail:
<EMAIL_ADDRESS>Internet: http://www.flyembraer.com.
    (3) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER> or<PHONE_NUMBER>.
    (4) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER>, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

    Issued in Renton, Washington, on December 16, 2009.
Stephen P. Boyd,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E9-30705 Filed 12-30-09; 8:45 am]

BILLING CODE 4910-13-P


CERTIFIED MAIL   Return Receipt Requested July 24, 2006 Document Control Office Office of Pollution Prevention and Toxics EPA East Room 6428 US Environmental Protection Agency 1200 Pennsylvania Avenue, NW Washington, DC 20460 Re: EPA   HQ   OPPT   2003  0012 DuPont Chambers Works NJPDES Permit No. NJ0005100 PFOA Data Submittal   Outfall DSN662 Weekly Grab Samples April 2006 Sample Data Dear Document Control Office,

As per Part IV, Section G. 5. a of the NJPDES permit, we are submitting a summary of PFOA analytical results for the weekly grab samples taken at internal outfall DSN662A to NJDEP on a monthly basis. Per your request, we are sending you a paper and electronic copy of the report for samples taken during April 2006. We will continue to send you the reports each month.

If you have any questions, please do not hesitate to call me at ( 856) 540 3105.

Sincerely,

Karen L. Coates SET Environmental Coordinator DuPont Chambers Works Enclosures Copies to:

Director, Chemical Control Division Office of Pollution Prevention and Toxics EPA East Room 4146 US Environmental Protection Agency 1201 Constitution Avenue, NW Washington, DE 20004 Ms. Susan Rosenwinkel ( cover letter only) Principal Environmental Engineer NJDEP Division of Water Quality Bureau of Point Source Permitting   Region 2 401 E. State Street P. O. Box 029 Trenton, NJ 08625 0029


[Federal Register Volume 87, Number 163 (Wednesday, August 24, 2022)]
[Notices]
[Pages 52018-52019]
[FR Doc No: 2022-18256]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2022-0024; OMB No. 1660-0085]

Agency Information Collection Activities: Proposed Collection;
Comment Request; Crisis Counseling Assistance and Training Program

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.

ACTION: 60-Day notice of revision and request for comments.

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SUMMARY: The Federal Emergency Management Agency (FEMA), as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public to take this opportunity to comment on a revision of
a currently approved information collection. In accordance with the
Paperwork Reduction Act of 1995, this notice seeks comments concerning
the Crisis Counseling Assistance and Training Program, which provides
federal funding in response to a State or Federally recognized Tribe's
request for Crisis Counseling services for a presidentially declared
major disaster.

DATES: Comments must be submitted on or before October 24, 2022.

ADDRESSES: To avoid duplicate submissions to the docket, please submit
comments at www.regulations.gov under Docket ID FEMA-2022-0024. Follow
the instructions for submitting comments.
    All submissions received must include the agency name and Docket
ID. Regardless of the method used for submitting comments or material,
all

submissions will be posted, without change, to the Federal eRulemaking
Portal at http://www.regulations.gov, and will include any personal
information you provide. Therefore, submitting this information makes
it public. You may wish to read the Privacy and Security Notice that is
available via a link on the homepage of www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Ani Brown, EM Specialist, Recovery/
Individual Assistance/Community Services at [email protected]
or<PHONE_NUMBER>. You may contact the Information Management Division
for copies of the proposed collection of information at email address:
[email protected].

SUPPLEMENTARY INFORMATION: Section 416 of the Robert T. Stafford
Disaster Relief and Emergency Assistance Act, (Pub. L. 93-288, as
amended and codified at 42 U.S.C. 5183) (``Act''), authorizes the
President to provide professional counseling services, including
financial assistance to States (which includes the fifty states, the
District of Columbia, and the U.S. territories), Federally recognized
Indian Tribal governments, local agencies or private mental health
organizations for professional counseling services, to survivors of
major disasters to relieve mental health problems caused or aggravated
by a major disaster or its aftermath. The implementing regulations for
Section 416 of the Stafford Act are at 44 CFR 206.171. Under 44 CFR
206.171 and by agreement, the U.S. Department of Health and Human
Services-Center for Mental Health Services (HHS-CMHS), which has
expertise in crisis counseling, coordinates with FEMA in administering
the Crisis Counseling Assistance and Training Program (CCP). FEMA and
HHS-CMHS provide program oversight, technical assistance, and training
to States and Federally recognized Tribes applying for CCP funding for
major disasters.
    FEMA is proposing to revise the collection by rewording the sub-
question from question 8 on the Crisis Counseling Assistance and
Training Program (CCP), Immediate Services Program (ISP) Application,
FEMA Form FF-104-FY-21-148 (formerly 003-0-1) and from question 12 on
the Crisis Counseling Assistance and Training Program, Regular Services
Program (RSP) Application, FEMA Form FF-104-FY-21-149 (formerly 003-0-
2). The rewording of these sub-questions will allow for greater
transparency of plans to ensure accessibility to all eligible
survivors.

Collection of Information

    Title: Crisis Counseling Assistance and Training Program.
    Type of Information Collection: Revision of a currently approved
information collection.
    OMB Number: 1660-0085.
    FEMA Forms: FEMA Form FF-104-FY-21-148 (formerly 003-0-1), Crisis
Counseling Assistance and Training Program, Immediate Services Program
Application; FEMA Form FF-104-FY-21-149 (formerly 003-0-2), Crisis
Counseling Assistance and Training Program, Regular Services Program
Application; ISP Final Report Narrative; Quarterly Report Narratives;
and Final RSP Report Narrative.
    Abstract: The CCP consists of two grant programs, the Immediate
Services Program (ISP) and the Regular Services Program (RSP). The ISP
and RSP provide supplemental funding to States and Federally recognized
Tribes following a Presidentially declared major disaster under the
Stafford Act. These grant programs provide funding for training and
services, including community outreach, public education, and
counseling techniques. States and Federally recognized Tribes are
required to submit an application that provides information on Needs
Assessment, Plan of Service, Program Management, and an accompanying
Budget.
    Affected Public: State, local or Tribal Government.
    Estimated Number of Respondents: 90.
    Estimated Number of Responses: 108.
    Estimated Total Annual Burden Hours: 1,728.
    Estimated Total Annual Respondent Cost: $141,334.
    Estimated Respondents' Operation and Maintenance Costs: $0.
    Estimated Respondents' Capital and Start-Up Costs: $0.
    Estimated Total Annual Cost to the Federal Government: $156,729.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.

Millicent Brown Wilson,
Records Management Branch Chief, Office of the Chief Administrative
Officer, Mission Support, Federal Emergency Management Agency,
Department of Homeland Security.
[FR Doc. 2022-18256 Filed 8-23-22; 8:45 am]
BILLING CODE 9111-24-P


[Federal Register: April 7, 2009 (Volume 74, Number 65)]
[Notices]
[Page 15741-15742]
[DOCID:fr07ap09-61]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0146]

Sodium Shale Oil Sulfonate Eligibility for Inclusion in
Monograph; Over-the-Counter Dandruff, Seborrheic Dermatitis, and
Psoriasis Drug Products for Human Use; Request for Safety and
Effectiveness Data

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of eligibility; request for data and information.

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SUMMARY: As part of our ongoing review of over-the-counter (OTC) drug
products, we (Food and Drug Administration (FDA)) are announcing a
call-for-data for safety and effectiveness information for sodium shale
oil sulfonate (SSOS), 0.5 to 2.0 percent, as a rinse-off treatment for
dandruff. We have reviewed a time and extent application (TEA) for SSOS
and determined that it is eligible for consideration in our OTC drug
monograph system. We will evaluate the submitted data and information
to determine whether SSOS can be generally recognized as safe and
effective (GRASE) as an OTC rinse-off treatment for dandruff.

DATES: Submit data, information, and general comments by July 6, 2009.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2009-
N-0146, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
    Submit written submissions in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (For paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, we are no longer
accepting

comments submitted to the agency by e-mail. We encourage you to
continue to submit electronic comments by using the Federal eRulemaking
Portal, as described previously, in the ADDRESSES portion of this
document under Electronic Submissions.
    Instructions: All submissions received must include the agency name
and Docket No. for this rulemaking. All comments received may be posted
without change to http://www.regulations.gov, including any personal
information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Michael L. Chasey, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, MS 5411, Silver Spring, MD 20993, 301-796-
2090.

SUPPLEMENTARY INFORMATION:

I. Eligibility of SSOS

    In November 2007, we received a TEA (Ref. 1) requesting that SSOS
be eligible for review under our OTC dandruff, seborrheic dermatitis,
and psoriasis monograph (21 CFR part 358 subpart H). In February 2008,
we received a supplement to the TEA, which included data and
information clarifying some points in the TEA (Ref. 2). After reviewing
the TEA and its supplement, we believe that it includes adequate data
demonstrating that SSOS has been marketed for a material time and to a
material extent as required by Sec.  330.14 (21 CFR 330.14) (Ref. 3).
SSOS-containing products have been marketed directly to consumers for
over 5 continuous years in 26 countries, with an estimated 21 million
dosage units marketed in 34 countries.
    The applicant requested that SSOS be indicated for use to treat
dandruff and psoriasis, in rinse-off and leave-on formulations.
However, nearly all of the submitted marketing data concerns SSOS in
rinse-off formulations for dandruff treatment. More marketing
experience of SSOS in leave-on formulations for dandruff treatment
would be necessary to find SSOS eligible in leave-on formulations. SSOS
in leave-on formulations does not meet the ``material extent''
requirement of Sec.  330.14(b)(2) and section 201 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321). Only 2 to 4 million dosage
units of SSOS in leave-on formulations have been sold, which is
inadequate compared to the number of dosage units sold for other
conditions found eligible for inclusion in the OTC drug monograph
system via the TEA process (tens of millions). Therefore, we conclude
that SSOS, 0.5 to 2.0 percent in rinse-off formulations for dandruff
treatment, is eligible for inclusion in the OTC dandruff, seborrheic
dermatitis, and psoriasis monograph.

II. Request for Data and Information

    We invite all interested persons to submit data and information on
the safety and effectiveness of SSOS in order for us to determine
whether it is GRASE and not misbranded under recommended conditions of
OTC use (see Sec.  330.14(f)). The data submitted should include animal
and human studies that meet current scientific standards. The TEA does
not include an official or proposed United States Pharmacopeia-National
Formulary (USP-NF) drug monograph. According to Sec.  330.14(i), an
official or proposed USP-NF monograph for each ingredient must also be
included as part of the safety and effectiveness data for this
ingredient.

III. Marketing Policy

    Under Sec.  330.14(h), any product containing SSOS may not be
marketed as an OTC drug in the United States at this time unless it is
the subject of an approved new drug application or abbreviated new drug
application.

IV. References

    The following references are on display in the Division of Dockets
Management (see ADDRESSES) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
    1. TEA for Sodium Shale Oil Sulfonate (SSOS) Submitted by DOW
Pharmaceutical Sciences, Inc., dated November 30, 2007.
    2. Supplement to the SSOS TEA Submitted by DOW Pharmaceutical
Sciences, Inc., dated February 1, 2008.
    3. FDA's evaluation of the TEA for SSOS.

    Dated: March 24, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-7766 Filed 4ndash;6-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 83, Number 249 (Monday, December 31, 2018)]
[Notices]
[Pages 67779-67785]
[FR Doc No: 2018-28378]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-84949; File Nos. SR-DTC-2018-012; SR-FICC-2018-014; SR-
NSCC-2018-013]

Self-Regulatory Organizations; The Depository Trust Company;
Fixed Income Clearing Corporation; National Securities Clearing
Corporation; Notice of Filing and Immediate Effectiveness of Proposed
Rule Changes To Revise the Clearing Agency Investment Policy

December 21, 2018.
    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 December 13, 2018, The Depository Trust Company (``DTC''), Fixed
Income Clearing Corporation (``FICC''), and National Securities
Clearing Corporation (``NSCC,'' and together with DTC and FICC, the
``Clearing Agencies'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule changes as described in
Items I, II and III below, which Items have been prepared primarily by
the Clearing Agencies. The Clearing Agencies filed the proposed rule
changes pursuant to Section 19(b)(3)(A) of the Act \3\ and Rule 19b-
4(f)(4) thereunder.\4\ The Commission is publishing this notice to
solicit comments on the proposed rule changes from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(4).
---------------------------------------------------------------------------

I. Clearing Agencies' Statement of the Terms of Substance of the
Proposed Rule Changes

    The proposed rule changes consists of amendments to the Clearing
Agency Investment Policy (``Investment Policy'') of the Clearing
Agencies in order to (1) update the governance for changes to the
Investment Policy and provide for annual approval of the Investment
Policy by the Board of Directors of each of the Clearing Agencies
(collectively, ``Boards''); (2) revise the process for identifying an
applicable external credit rating for a potential investment
counterparty when there are discrepancies between available external
credit ratings for that potential counterparty; (3) amend the authority
to approve (a) the establishment of an investment relationship with an
investment counterparty, (b) investment transactions that exceed
applicable investment limits, and (c) investment

transactions in high grade corporate debt and U.S. Treasury securities;
and (4) make technical corrections and revisions to clarify and
simplify statements in the Investment Policy; as described in greater
detail below.

II. Clearing Agencies' Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Changes

    In their filings with the Commission, the Clearing Agencies
included statements concerning the purpose of and basis for the
proposed rule changes and discussed any comments they received on the
proposed rule changes. The text of these statements may be examined at
the places specified in Item IV below. The Clearing Agencies have
prepared summaries, set forth in sections A, B, and C below, of the
most significant aspects of such statements.

(A) Clearing Agencies' Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Changes

1. Purpose
    The Clearing Agencies are proposing to revise the Investment
Policy, which was adopted in December 2016 \5\ and are maintained in
compliance with Rule 17Ad-22(e)(16) under the Act.\6\
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 79528 (December 12,
2016), 81 FR 91232 (December 16, 2016) (SR-DTC-2016-007, SR-FICC-
2016-005, SR-NSCC-2016-003).
    \6\ 17 CFR 240.17Ad-22(e)(16). As discussed in this filing, the
Investment Policy also addresses compliance with the requirements of
Rule 17Ad-22(e)(3). 17 CFR 240.17Ad-22(e)(3).
---------------------------------------------------------------------------

Overview of the Investment Policy
    The Investment Policy governs the management, custody and
investment of cash deposited to the respective NSCC and FICC Clearing
Funds, and the DTC Participants Fund,\7\ the proprietary liquid net
assets (cash and cash equivalents) of the Clearing Agencies, and other
funds held by the Clearing Agencies pursuant to their respective rules.
---------------------------------------------------------------------------

    \7\ The respective Clearing Funds of NSCC and FICC, and the DTC
Participants Fund are described further in the Rules & Procedures of
NSCC (``NSCC Rules''), the DTC Rules, By-laws and Organization
Certificate (``DTC Rules''), the Clearing Rules of the Mortgage-
Backed Securities Division of FICC (``MBSD Rules'') or the Rulebook
of the Government Securities Division of FICC (``GSD Rules''),
respectively, available at http://dtcc.com/legal/rules-and-procedures. See Rule 4 (Clearing Fund) of the NSCC Rules, Rule 4
(Participants Fund and Participants Investment) of the DTC Rules,
Rule 4 (Clearing Fund and Loss Allocation) of the GSD Rules and Rule
4 (Clearing Fund and Loss Allocation) of the MBSD Rules.
---------------------------------------------------------------------------

    The Investment Policy identifies the guiding principles for
investments and defines the roles and responsibilities of DTCC staff in
administering the Investment Policy pursuant to those principles. The
Investment Policy is co-owned by DTCC's Treasury group (``Treasury'')
\8\ and the Counterparty Credit Risk team (``CCR'') within DTCC's Group
Chief Risk Office (``GCRO'').\9\ Treasury is responsible for
identifying potential counterparties to investment transactions,
establishing and managing investment relationships with approved
investment counterparties, and making and monitoring all investment
transactions with respect to the Clearing Agencies. CCR is responsible
for conducting a credit review of any potential counterparty, updating
those reviews on a quarterly basis, and establishing an investment
limit for each counterparty.
---------------------------------------------------------------------------

    \8\ Treasury is a part of the DTCC Finance Department and is
responsible for the safeguarding, investment and disbursement of
funds on behalf of the Clearing Agencies and in accordance with the
principles outlined in the Investment Policy.
    \9\ Among other responsibilities, GCRO is generally responsible
for the systems and processes designed to identify and manage
credit, market and liquidity risks to the Clearing Agencies.
---------------------------------------------------------------------------

    The Investment Policy also identifies sources of funds that may be
invested, and the permitted investments of those funds, including the
authority required to make such investments and the parameters of, and
limitations on, each type of investment. Allowable investments include
bank deposits, reverse repurchase agreements, direct obligations of the
U.S. government, money market mutual funds, high-grade corporate debt,
and hedge transactions. Finally, the Investment Policy defines the
approval authority required to exceed established investment limits.
Proposed Revisions to the Investment Policy
    The Investment Policy is reviewed and approved by the Boards
annually. In connection with the most recent annual review of the
Investment Policy, the Clearing Agencies have decided to propose
certain revisions and updates. These proposed revisions, described in
greater detail below, are designed to update the Investment Policy and
help ensure that it continues to operate as intended.
1. Investment Policy Change Management and Annual Board Approval
    The Clearing Agencies are proposing revisions to two aspects of
governance in the Investment Policy: (1) Approving changes to the
Investment Policy and (2) annual approval by the Board, as described
below.
a. Governance for Approving Changes to Investment Policy
    Currently, the Investment Policy includes a statement that
``routine'' changes to the Investment Policy must be approved jointly
by an officer in Treasury and an officer in CCR, and that material
changes to the Investment Policy must be approved by the Boards, or
such committee as may be delegated authority by the Boards from time to
time.
    The Boards have delegated to the General Counsel and the Deputy
General Counsels of the Clearing Agencies the authority to approve
certain proposed rule changes of the Clearing Agencies and the filings
with respect to such proposed rule changes required by Rule 19b-4 under
the Act.\10\ Specifically, the Boards have delegated to the General
Counsel and Deputy General Counsels of the Clearing Agencies authority
to approve (1) proposed rule changes that may be filed pursuant to
Section 19(b)(3)(A) of the Act,\11\ (2) proposed rule changes that
constitute clarifications, corrections or minor changes in the rules of
the Clearing Agencies but that will not be filed pursuant to Section
19(b)(3)(A) of the Act,\12\ in each case, other than any rule change
where the aggregate annual fees generated as a result of such rule
change are anticipated to be more than $1,000,000 at the time of the
filing, and (3) all proposed changes that are subject to an advance
notice as required by Rule 19b-4(n) under the Act \13\ but do not
constitute a change to the rules of Clearing Agencies.
---------------------------------------------------------------------------

    \10\ 17 CFR 240.19b-4.
    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ Id.
    \13\ 17 CFR 240.19b-4(n).
---------------------------------------------------------------------------

    Therefore, the statement within the Investment Policy that
``routine'' changes to the Investment Policy must be approved jointly
by an officer in Treasury and an officer in CCR, and that material
changes to the Investment Policy must be approved by the Boards or
committees of the Boards is inconsistent with these existing
delegations of approval authority. As such, the Clearing Agencies are
proposing to amend the Investment Policy to clarify that changes to the
Investment Policy may be approved by either (1) the Boards, (2) such
Board committees as may be delegated authority by the Boards from time
to time pursuant to their charters, or (3), with respect to certain
changes, the General Counsel or Deputy General Counsels of the Clearing
Agencies, pursuant to authority delegated by the

Boards and with the advice and direction of Treasury and CCR.
    The proposed change would make the Investment Policy consistent
with existing internal delegations of authority and would also
facilitate expedited review and approval of changes that may not
require the review and approval of the Boards or committees of the
Boards.
b. Annual Approval of Investment Policy by Boards
    The Investment Policy currently states that the Boards or such
committees as may be delegated authority from time to time shall review
the Investment Policy on an annual basis.
    Rule 17Ad-22(e)(3) under the Act requires the Clearing Agencies to
maintain a sound risk management framework for comprehensively managing
the risks that arise in or are borne by the Clearing Agencies,
including investment and custody risks.\14\ Rule 17Ad-22(e)(3)(i) under
the Act requires that the risk management policies, procedures, and
systems that are maintained in compliance with Rule 17Ad-22(e)(3) be
subject to review on a specified periodic basis and be approved by the
Boards annually.\15\ As stated above, the Investment Policy governs the
management, custody and investment held by the Clearing Agencies, and
is maintained in order to manage the Clearing Agencies' investment and
custody risks, as required by Rule 17Ad-22(e)(3) under the Act.\16\
Therefore, the Investment Policy must be approved by the Boards
annually, as required by Rule 17Ad-22(e)(3)(i) under the Act.\17\
---------------------------------------------------------------------------

    \14\ 17 CFR 240.17Ad-22(e)(3).
    \15\ 17 CFR 240.17Ad-22(e)(3)(i).
    \16\ 17 CFR 240.17Ad-22(e)(3).
    \17\ 17 CFR 240.17Ad-22(e)(3)(i).
---------------------------------------------------------------------------

    The Clearing Agencies are proposing to amend the Investment Policy
to provide that the Investment Policy shall be approved annually by the
Boards or such committees as may be delegated authority from time to
time.\18\ The proposed change would align the governance of the
Investment Policy with the applicable requirements of Rule 17Ad-
22(e)(3)(i) under the Act.\19\
---------------------------------------------------------------------------

    \18\ Id.
    \19\ Id.
---------------------------------------------------------------------------

2. Process for Identifying External Credit Rating of Potential
Investment Counterparties
    One of the responsibilities of CCR under the Investment Policy is
to perform credit reviews of potential investment counterparties. The
credit review is used to determine if the Clearing Agencies should
establish an investment relationship with that entity, and what, if
any, limits should be placed on investments with that entity as an
investment counterparty. These credit reviews may include, for example,
a business description, identification of key risks and any mitigants
to those risks, a general financial analysis of the potential
counterparty, such counterparty's available external credit ratings,
and the recommended investment limit for such counterparty. The
Investment Policy sets a minimum external credit rating for potential
investment counterparties for specified types of investments. External
credit ratings may be assigned by either S&P Global Ratings, Moody's
Investors Service, Inc., or Fitch Ratings Inc.
    Currently, the Investment Policy states that if there is a single
notch discrepancy between available external credit ratings, CCR shall
use the more favorable rating available. The Investment Policy further
states that, if there is a multiple notch discrepancy between available
external credit ratings for a potential investment counterparty, CCR
may use its discretion, based on information available to it, in
determining the applicable credit rating for its credit review of that
counterparty.
    The Clearing Agencies are proposing to amend the Investment Policy
to remove CCR's discretion that may be used when there is a multiple
notch discrepancy between the external credit ratings, and instead
require that CCR shall use the rating that is one notch above the
lowest available external credit rating for that counterparty.
    The Clearing Agencies determined that this approach would be
appropriate because credit ratings may be obtained from one of the
three credit rating agencies identified above, so there could only be a
maximum of three available credit ratings for an entity. As such, under
this proposed approach, the middle available rating would be applied
where there is a multiple notch discrepancy between available credit
ratings.
    The Clearing Agencies believe the proposed change would improve the
process for applying an external credit rating in connection with
credit reviews because it would create a clear and objective approach
to identifying the applicable external credit rating in these
circumstances by removing CCR's discretion in determining which rating
to apply.
3. Approval Authority for Investments Relationships, Exceeding
Investment Limits and Certain Investment Transactions
    The Investment Policy identifies the groups of individuals who have
the authority to approve (1) the establishment of an investment
relationship with an investment counterparty, (2) investment
transactions that exceed applicable investment limits, and (3)
investment transactions in high grade corporate debt and U.S. Treasury
securities. The Clearing Agencies are proposing to revise the approval
authority in the Investments Policy, as described below.
a. Focus the Approval Authority for Investments Relationships and
Exceeding Investment Limits to Managing Director in CCR
    The Clearing Agencies are proposing to amend the authority for
approving the establishment of investment relationships and investment
transactions that exceed investment limits to restrict one of the
individuals authorized to provide such approvals to a Managing Director
in CCR, rather than any Managing Director in GCRO, for the reasons
described below.
    First, with respect to the authority to establish an investment
relationship with an investment counterparty, the Investment Policy
currently identifies two groups of authorized individuals--``Group A''
and ``Group B''--and provides that an investment relationship may be
approved by either two individuals from Group A acting jointly, or by
one individual from Group A and one individual from Group B acting
jointly. Currently, Group A includes the Group Chief Risk Officer or a
Managing Director in the Financial Risk Management group (the former
name of the GCRO).\20\
---------------------------------------------------------------------------

    \20\ As described below, the Clearing Agencies are proposing to
make a technical revision to the Investment Policy to update all
references to the Financial Risk Management group, or ``FRM,'' to
the Group Chief Risk Office, or ``GCRO.''
---------------------------------------------------------------------------

    Second, with respect to approving investment transactions that
exceed applicable investment limits, the Investment Policy currently
identifies three groups of individuals--``Group A,'' ``Group B,'' and
``Group C''--and provides that an investment transaction that exceeds
applicable investment limits may be approved by either one individual
in Group A and one individual from Group B acting jointly; or one
individual in Group A or one individual in Group B, and one individual
in Group C, acting jointly. Currently, Group B includes both a

Managing Director in GCRO and the Group Chief Risk Officer.
    The Clearing Agencies are proposing to limit the Managing Director
in GCRO who is authorized to provide these approvals to a Managing
Director in the CCR group within GCRO. As described above, CCR is
responsible for conducting the credit reviews of potential investment
counterparties, and for setting investment limits for investment
counterparties. Therefore, a Managing Director in CCR is more closely
involved in conducting credit reviews of potential investment
counterparties and setting investment limits that are appropriate based
on those reviews, where other Managing Directors within GCRO do not
have a role in the administration of the Investment Policy. Therefore,
the Clearing Agencies believe this proposed change is appropriate
because it would focus the authorization to an individual who may be
more capable of providing an informed authorization when necessary.
    The Clearing Agencies are also proposing to provide that a Managing
Director in CCR may assign a delegate within CCR with the title of
Executive Director or higher, to jointly approve investment
transactions that exceed applicable limits in the event a CCR Managing
Director is unavailable. The approval of these transactions may be
required in a short timeframe. Therefore, the proposed change would
allow the Clearing Agencies to obtain these joint approvals from an
officer within CCR, when necessary, without unnecessary delay in the
event a Managing Director in CCR is not available to provide the
requested authorization.
b. Revising Approval Authority for Certain Investment Transactions
    The Clearing Agencies are proposing to make two revisions to the
approval authority for investment transactions in high grade corporate
debt and U.S. Treasury securities, as described below.
    Currently, the Investment Policy provides that investment
transactions in high grade corporate debt and U.S. Treasury securities
where the remaining time to maturity is two years or less must be
approved by two individuals, acting jointly, who are identified in a
group of individuals that includes both senior level executives and
lower level officers. The value of investments that mature on a longer
timeframe are subject to greater uncertainty over that period and such
investments are generally viewed as posing greater risk. Therefore, the
Investment Policy provides that investment transactions in high grade
corporate debt and U.S. Treasury securities where the remaining time to
maturity is more than two years must be approved by two individuals,
acting jointly, from the same group of individuals who are authorized
to approve such investments that mature on a shorter timeframe, so long
as at least one of those individuals is a senior level executive.
    First, the Clearing Agencies are proposing to revise the scope of
investments that the two groups of individuals are authorized to
approve. The proposed change would provide the first group of
individuals with authority to approve investments, with two of them
acting jointly, for a time to maturity of one year or less, and would
provide the second group of individuals with authority to approve
investments with a time to maturity of greater than one year, and up to
a maximum of ten years for investments in U.S. Treasury securities and
up to a maximum of five years for investments in high grade corporate
debt. This proposed change would provide for a more conservative
approach to approving these investments by limiting the investments
that may be approved by the first group of authorized individuals to
only those that mature on a shorter timeframe, and pose less risk.
    Second, the Clearing Agencies are proposing to include an Executive
Director in Finance in the first group of individuals, who are
authorized to act jointly to approve investment transactions with a
remaining time to maturity of one year or less. This proposed change
would provide the Clearing Agencies with more flexibility to authorize
investment transactions where the time to maturity is one year or less
by authorizing an additional officer to approve this revised set of
investments. The Investment Policy would continue to require that at
least one of the individuals who approve investments that have a longer
time to maturity be a senior level executive.
4. Technical Revisions
    The Clearing Agencies are proposing to reorganize and reorder
certain sections of the Investment Policy, and make other updates,
corrections and clarifications, as described below.
a. Reordering and Reorganizing Certain Sections of the Investment
Policy
    First, the Clearing Agencies are proposing to remove Section 1.1,
titled ``Document Control Information,'' from the Investment Policy.
The information under this heading would be incorporated into the
Overview in Section 1, and this proposed change would simplify the
organization of this Section.
    Second, the Clearing Agencies are proposing to move the information
currently in Section 7 to other sections in the Investment Policy and
eliminate Section 7. Currently, Section 7.1 describes the
authorizations for establishing investment relationships, and Section
7.2 describes the authorizations for entering into investment
transactions. The information currently in Section 7.1 would be moved
to a new Section 4.3. This proposed change would revise the Investment
Policy so the authorizations for establishing investment relationships
appears directly after the description of credit reviews of potential
investment counterparties performed by CCR in Section 4.2.
    The information currently in Section 7.2 would be moved to Section
6.2. This proposed change would revise the Investment Policy so the
authorizations for investment transactions appear in the same Section
as the description of the applicable investment type. As such, Sections
6.2.1, 6.2.2, and 6.2.4, which describe investments in bank deposits,
reverse repurchase agreements, and money market mutual funds,
respectively, would include a statement that investment transactions in
these investment types are authorized pursuant to Section 4.1 of the
Investment Policy and no separate approvals for such investment
transactions are required. Sections 6.2.3 and 6.2.5, which describe
investments in U.S. treasury securities and high-grade corporate debt,
respectively, would include a table of the required authorizations for
investment transactions in these investment types. The authorizations
described in these tables would be amended as described above. The
Investment Policy would also be updated to make conforming changes to
update internal cross-references to these reorganized Sections.
    Third, the Clearing Agencies are proposing to revise Section 6.2.6,
which describes hedge transactions. The proposed change would move a
statement regarding factors that may be considered when authorizing a
hedge transaction to appear above the table of authorizations of those
transactions. This proposed change would align Section 6.2.6 to be
organized similarly to other subsections within Section 6.2, such that
the information regarding authorizations of those transactions appears
at the end of the subsection.
    The Clearing Agencies believe each of the proposed changes are
appropriate. By reorganization the Investment Policy such that sections
regarding similar

matters appear together, the proposed changes would improve the clarity
of the Investment Policy.
b. Other Updates and Technical Revisions
    The Clearing Agencies are also proposing to make other updates and
technical revisions to the Investment Policy. These technical revisions
would, for example, correct internal cross-references, revise the use
of defined terms, and clarify descriptions within the Investment
Policy, without changing the substantive statements being revised.
    For example, Section 6.2.1 would be revised to include term
deposits in a list of types of bank deposit investment transactions
that may be executed pursuant to the Investment Policy. While the
existing list was intended to be non-exhaustive, the proposed change
would clarify that term bank deposits are also permitted. As another
example, the Investment Policy would be revised to reflect a change to
the name of the DTCC's Financial Risk Management group, or ``FRM,'' to
the GCRO.
    The Clearing Agencies believe the proposed updates and technical
revisions would improve the clarity and accuracy of the Investment
Policy and, therefore, would facilitate the execution of the Investment
Policy.
2. Statutory Basis
    The Clearing Agencies believe that the proposed rule changes are
consistent with the requirements of the Act and the rules and
regulations thereunder applicable to a registered clearing agency. In
particular, the Clearing Agencies believe that the proposed
modifications to the Investment Policy are consistent with Section
17A(b)(3)(F) of the Act \21\ and Rules 17Ad-22(e)(3)(i) and (16) under
the Act,\22\ for the reasons described below.
---------------------------------------------------------------------------

    \21\ 15 U.S.C. 78q-1(b)(3)(F).
    \22\ 17 CFR 240.17Ad-22(e)(3)(i) and (16).
---------------------------------------------------------------------------

    Section 17A(b)(3)(F) of the Act requires, in part, that the rules
of each of the Clearing Agencies be designed to assure the safeguarding
of securities and funds which are in the custody or control of each of
the Clearing Agencies or for which they are responsible.\23\ The
investment guidelines and governance procedures set forth in the
Investment Policy are designed to safeguard funds which are in the
custody or control of the Clearing Agencies or for which they are
responsible. Such protections include, for example, following a prudent
and conservative investment philosophy that places the highest priority
on maximizing liquidity and risk avoidance. The Clearing Agencies
believe each of these proposed changes would help facilitate the
effective execution of the Investment Policy pursuant to the guiding
principle set forth therein. Therefore, the Clearing Agencies believe
the proposed changes would allow the Clearing Agencies to continue to
operate the Investment Policy pursuant to a prudent and conservative
investment philosophy that assures the safeguarding of securities and
funds which are in their custody and control, or for which they are
responsible.
---------------------------------------------------------------------------

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

    First, the Clearing Agencies believe the proposed changes to the
Investment Policy governance would improve the processes for
maintaining the Investment Policy and ensuring it continues to operate
as intended. The proposed changes to reflect the existing delegation of
authority to the General Counsel and Deputy General Counsels of the
Clearing Agencies to approve certain changes to the Investment Policy
would align this process to existing governance and delegations of
authority within the Clearing Agencies. This proposed change would
permit an expedited review and approval of changes that do not require
action by the Boards or Board committees. In this way, the Clearing
Agencies believe the proposed change would simplify the steps necessary
for the Clearing Agencies to make certain non-material changes to the
Investment Policy, subject to required regulatory review and approval
of such changes. Meanwhile, the Clearing Agencies believe that the
proposed change to require annual approval of the Investment Policy
would provide for stronger Board oversight and create an important
control over the Investment Policy's effectiveness.
    Second, the Clearing Agencies believe the proposed change to the
process for identifying an applicable external credit rating for
potential investment counterparties when there is a multiple notch
discrepancy between available ratings would improve the credit reviews
of those entities. The proposed change would improve credit reviews by
creating a more objective approach to this aspect of those reviews and
creating more consistency in the evaluation of these entities.
Understanding the risks that may be presented by an investment
counterparty is an important aspect of the Investment Policy's
guidelines and governance procedures that are designed to safeguard
funds which are in the custody or control of the Clearing Agencies or
for which they are responsible.
    Third, the Clearing Agencies believe the proposed change to certain
approval authority within the Investment Policy would both enable the
Clearing Agencies to authorize those individuals who are involved with
the matters that they may be asked to approve, and would facilitate
those approvals by authorizing additional individuals to approve lower
risk matters. The proposed change to the approval authority for
establishing investment relationships and entering investment
transactions that exceed applicable limits to include only Managing
Directors in CCR would refine this approval authority to individuals
who are involved in these matters, and may be better able to provide an
informed approval. The proposed change to the approval authority for
investment transactions with maturity time would shift that authority
to senior executives for investments that pose greater risk, creating a
more conservative approach to those approvals. The proposed change to
authorize Executive Directors in Finance to approve investment
transactions with remaining time to maturity of less than one year
would facilitate the approval of these transactions that pose less risk
to the Clearing Agencies.
    Finally, the Clearing Agencies believe the proposed changes to
reorganize certain sections within the Investment Policy and the
proposed updates and technical revisions to the Investment Policy would
improve the clarity and accuracy of the Investment Policy. By creating
clearer descriptions, the Clearing Agencies believe these proposed
changes would make the Investment Policy more effective in governing
the management, custody, and investment of funds of and held by the
Clearing Agencies.
    For the reasons described above, the Clearing Agencies believe the
proposed changes would improve the effectiveness of the Investment
Policy and allow the Investment Policy to continue to be administered
in alignment with the investment guidelines and governance procedures
set forth therein. Given that such guidelines and governance procedures
are designed to safeguard funds which are in the custody or control of
the Clearing Agencies or for which they are responsible, the Clearing
Agencies believe the proposed changes are consistent with the
requirements of Section 17A(b)(3)(F) of the Act.\24\
---------------------------------------------------------------------------

    \24\ Id.
---------------------------------------------------------------------------

    Rule 17Ad-22(e)(3)(i) requires, in part, that the Clearing Agencies
establish, implement, maintain and

enforce written policies and procedures reasonably designed to maintain
a sound risk management framework for comprehensively managing
investment and custody risks that arise in or are borne by the Clearing
Agencies, which includes risk management policies, procedures, and
systems designed to identify, measure, monitor, and manage the range of
risks that arise in or are borne by the Clearing Agencies, that are
subject to review on a specified periodic basis and approved by the
board of directors annually.\25\ The Clearing Agencies are proposing to
revise the Investment Policy to require that it be reviewed and
approved by the Boards, or an authorized Board Committee, at least
annually. The Boards, or an authorized Board Committee, will be
provided with a copy of the Investment Policy at a regularly scheduled
meeting, along with a memorandum describing any changes that had been
made to the Investment Policy since its last annual approval. This
proposed change would provide for important oversight of the operation
of the Investment Policy and its continued effectiveness in governing
the management, custody and investment of funds held by the Clearing
Agencies. The proposed change is also designed to align the governance
of the Investment Policy with the applicable requirements of Rule 17Ad-
22(e)(3)(i) under the Act.\26\
---------------------------------------------------------------------------

    \25\ 17 CFR 240.17Ad-22(e)(3)(i).
    \26\ Id.
---------------------------------------------------------------------------

    Rule 17Ad-22(e)(16) under the Act requires the Clearing Agencies to
establish, implement, maintain and enforce written policies and
procedures reasonably designed to safeguard the Clearing Agencies' own
and their participants' assets, minimize the risk of loss and delay in
access to these assets, and invest such assets in instruments with
minimal credit, market, and liquidity risks.\27\
---------------------------------------------------------------------------

    \27\ 17 CFR 240.17Ad-22(e)(16).
---------------------------------------------------------------------------

    The Clearing Agencies believe that the Investment Policy follows a
prudent and conservative investment philosophy, placing the highest
priority on maximizing liquidity and avoiding risk of loss, by
requiring the segregation of funds of each Clearing Agency and of types
of funds of each Clearing Agency, using external credit ratings in the
evaluation of counterparties, and establishing investment limits by
counterparty as well as investment type. As originally implemented, the
Investment Policy was designed to meet the requirements of Rule 17Ad-
22(e)(16) under the Act.\28\
---------------------------------------------------------------------------

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

    For the reasons stated above, the Clearing Agencies believe that
each of the proposed revisions would improve the administration of the
Investment Policy and would make the Investment Policy more effective
in governing the management, custody, and investment of funds of and
held by the Clearing Agencies. In this way, the proposed changes would
better allow the Clearing Agencies to maintain these documents in a way
that is designed to meet the requirements of Rule 17Ad-22(e)(16).
Therefore, the Clearing Agencies believe the proposed revisions would
be consistent with the requirements of Rule 17Ad-22(e)(16) under the
Act.\29\
---------------------------------------------------------------------------

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

(B) Clearing Agencies' Statement on Burden on Competition

    Each of the Clearing Agencies believes that none of the proposed
revisions to the Investment Policy would have any impact, or impose any
burden, on competition. The Investment Policy applies equally to the
Clearing Fund and Participants Fund deposits, as applicable, of each
member of the Clearing Agencies, and establishes a uniform policy at
the Clearing Agencies. The proposed changes to the Investment Policy
would not affect any changes on the fundamental purpose or operation of
this document and, as such, would also not have any impact, or impose
any burden, on competition.

(C) Clearing Agencies' Statement on Comments on the Proposed Rule
Changes Received From Members, Participants, or Others

    The Clearing Agencies have not solicited or received any written
comments relating to this proposal. The Clearing Agencies will notify
the Commission of any written comments received by the Clearing
Agencies.

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

    The foregoing rule changes have become effective pursuant to
Section 19(b)(3)(A) of the Act \30\ and paragraph (f) of Rule 19b-4
thereunder.\31\ At any time within 60 days of the filing of the
proposed rule change, the Commission summarily may temporarily suspend
such rule changes if it appears to the Commission that such action is
necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \30\ 15 U.S.C. 78s(b)(3)(A).
    \31\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
changes are 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-DTC-2018-012, SR-FICC-2018-014, or SR-NSCC-2018-013 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-DTC-2018-012, SR-FICC-
2018-014, or SR-NSCC-2018-013. One of these file numbers 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
submissions, all subsequent amendments, all written statements with
respect to the proposed rule changes that are filed with the
Commission, and all written communications relating to the proposed
rule changes 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 filings also will be available for inspection
and copying at the principal office of the Clearing Agencies 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-DTC-2018-012, SR-FICC-2018-
014, or SR-NSCC-2018-013 and should be submitted on or before January
22, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\32\
---------------------------------------------------------------------------

    \32\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2018-28378 Filed 12-28-18; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 182 (Wednesday, September 19, 2018)]
[Proposed Rules]
[Pages 47324-47325]
[FR Doc No: 2018-20335]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2018-0845]

Safety Zones; Spaceport Camden, Woodbine, GA

AGENCY: Coast Guard, DHS.

ACTION: Notice of public meeting; request for comments.

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

SUMMARY: The U.S. Coast Guard announces a public meeting to receive
comments on a Notice of Inquiry (NOI) involving a proposal to establish
safety zones on the navigable waterways in the vicinity of the proposed
Spaceport Camden, near Woodbine, Georgia, during rocket tests,
launches, and landing operations. The NOI was published in the Federal
Register on September 11, 2018. The purpose of this public meeting is
to receive comments regarding the proposed safety zones.

DATES: A public meeting will be held on September 27, 2018 from 5 p.m.
to 7 p.m. to provide an opportunity for oral comments. Written comments
and

related material may also be submitted to Coast Guard personnel
specified at that meeting. All comments and related material submitted
after the meeting must be received by the Coast Guard on or before
October 11, 2018.

ADDRESSES: The public meeting will be held at the Camden County Public
Service Authority Recreation Center, 1050 Wildcat Drive, Kingsland,
Georgia 31548. Parking is available at the Recreation Center.
    You may submit written comments identified by docket number USCG-
2018-0845 using the Federal eRulemaking Portal at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: If you have questions concerning the
meeting or NOI, please call or email LT Joseph Palmquist, Coast Guard;
telephone<PHONE_NUMBER> ext. 221, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Background and Purpose

    We are announcing a public meeting to receive comments regarding a
proposal to establish safety zones on the navigable waterways in the
vicinity of the proposed Spaceport Camden, near Woodbine, Georgia. We
published a Notice of Inquiry (NOI) in the Federal Register on
September 11, 2018 (83 FR 45864), entitled ``Safety Zone; Spaceport
Camden, Woodbine, GA.'' In it we stated our intention to hold a public
meeting, and to publish a notice announcing the location and date (83
FR 45866). This document is the notice of that meeting.
    In the NOI, we announced that the Board of County Commissioners of
Camden County, Georgia proposes to develop and operate a commercial
space launch site, called Spaceport Camden, in an unincorporated area
of Camden County, Georgia, approximately 11.5 miles due east of the
town of Woodbine, Georgia. The site, near Floyd Creek, is on the coast,
surrounded by salt marshes to the east and south, and the Satilla River
to the north. In support of Spaceport Camden, the Board of County
Commissioners of Camden County, Georgia requested that the Coast Guard
establish safety zones which would be effective during launch, landing,
and rocket test activities at the site.
    The Coast Guard establishes safety zones over areas of water and/or
shore for safety or environmental purposes pursuant to the authority
contained in 33 CFR part 165. A safety zone is a ``. . . water area,
shore area, or water and shore area to which, for safety or
environmental purposes, access is limited to authorized persons,
vehicles, or vessels.''
    The applicants for Spaceport Camden propose up to 12 annual
launches and landings during daylight hours, with one possible
nighttime launch per year, of liquid-fueled, small to medium-large
lift-class, orbital and suborbital vertical launch vehicles. In support
of the proposed launches, the applicants for Spaceport Camden propose
up to 12 engine tests per year. Launch trajectories would vary from 83
to 115 degrees for vehicles up to and including medium-large lift
class. Because the trajectory of these launches would take the rockets
over various navigable waterways, creeks and tributaries, sections of
land, and areas offshore, applicants are required to limit or restrict
access to certain areas surrounding a rocket test/launch site based on
specific hazard analysis. The applicant's request to establish safety
zones during rocket launches, landings, and various tests is one
element in meeting these safety requirements
    The range of potential safety zones for launch and landing
activities encompasses an area which accounts for safety concerns
associated with all potential launch trajectories. Individual launch
safety zones could be smaller and depend on several factors unique to
each event, such as actual trajectory, lift class, and payload. The
range of potential safety zones for rocket tests encompasses a smaller
area directly around the commercial space launch site. In all
instances, the potential safety zones would be necessary to safeguard
persons, property, and the marine environment during rocket launches,
landings, and rocket test activities.
    You may view the NOI in our online docket and comments submitted
thus far by going to http://www.regulations.gov. Once there, insert
``USCG-2018-0845'' in the ``Keyword'' box and click ``Search.''
    We encourage you to participate in this NOI by submitting comments
either orally at the meeting or in writing. If you bring written
comments to the meeting, you may submit them to Coast Guard personnel
specified at the meeting to receive written comments. These comments
will be submitted to our online public docket. All comments received
will be posted without change to http://www.regulations.gov and will
include any personal information you have provided.
    Comments submitted after the meeting must reach the Coast Guard on
or before October 11, 2018. We encourage you to submit comments through
the Federal eRulemaking Portal at http://www.regulations.gov. If your
material cannot be submitted using http://www.regulations.gov, contact
the person in the FOR FURTHER INFORMATION CONTACT section of this
document for alternate instructions.
    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the March 24, 2005, issue of the
Federal Register (70 FR 15086).

II. Information on Service for Individuals With Disabilities

    For information on facilities or services for individuals with
disabilities or to request special assistance at the public meeting,
contact LT Joseph Palmquist at the telephone number or email address
indicated under the FOR FURTHER INFORMATION CONTACT section of this
notice.

III. Public Meeting

    The Coast Guard will hold a public meeting to receive comments on
the proposal to establish safety zones on the navigable waterways in
and near the proposed Spaceport Camden, near Woodbine, GA. The meeting
will take place on September 27, 2018 from 5 p.m. to 7 p.m. at Camden
County Public Service Authority Recreation Center, 1050 Wildcat Drive,
Kingsland, Georgia 31548. Parking is available at the Recreation
Center.

    Dated: September 14, 2018.
N.C. Witt,
Commander, U.S. Coast Guard, Captain of the Port Savannah.
[FR Doc. 2018-20335 Filed 9-18-18; 8:45 am]
 BILLING CODE 9110-04-P


Comments Prepared for the EPA Pesticide Program Dialogue Subcommittee on Worker Safety March 21, 2006 The California Minor Crops Council ( CMCC) is a coalition of 18 commodity groups and includes tree fruit, vines, vegetables, berries, and root crops. Our commodities have taken a proactive approach to pest management in the last decade by establishing aggressive research and extension programs to increase adoption of reduced risk pest management practices that provide consistent, economical pest control, while being protective of consumers, workers, and the environment.

We have reviewed the materials presented on February 27 at the one day meeting and are providing the following comments. We look forward to working with the PPDC as it works through these issues over the next year and a half prior to rulemaking.

I ssues of concern that we believe warrant further discussion include the following:

  Training every 2 years instead of 5   We need to assess the practicality of this proposal along with costs associated with increased training intervals. This issue needs further input, clarification and justification.

  Hazard communication on all pesticides   According to the information discussed on February 27, it appears that the new rules would be expanded to include all pesticides, not just Restricted Use Pesticides. This issue needs further clarification, input and justification.

  Exemptions to Regulations   Activity Based REIs.   It is important that growers maintain the flexibility to enter fields as horticultural and pest management issues arise; these issues are especially critical for high value, specialty type crops which are much more labor intensive as compared to field crops. This is a critical issue for our farmers and workers. This issue needs further clarification, input and justification.

  Protecting Children from Treated Areas

  Cost analysis for training, including staffing in times of state cutbacks   how do we resolve this? Implementation plans for improved worker and applicator training, especially as new technologies are developed, is critically important yet budgets for these programs are being cut back in most states. This issue needs to be addressed in this process and the costs to agencies, educational institutions, cooperative extension, and growers need to be identified.

  Stakeholder involvement to this point: We are concerned that very few ag groups have participated in the development of this document; we request that sources of input to be expanded throughout this process. Currently, the following stakeholders are mentioned: CTAG, Administrative Law Judge, NAAA, National Assessment Group, OMB, Advocacy Groups, States. Input from Crop Advisor Associations and Agricultural Employers do not appear to be consistently engaged in these discussions. We wish for the level of input by these and individual commodity groups We support the Agency as it seeks to improve delivery of worker safety and programs to communicate hazards effectively to user groups. We fully support the use of stainable practices, integrated pest management ( IPM), and establishment of safety standards for workers.

Thank you for giving stakeholders the opportunity to provide input at this point in the process and we look forward to further discussions and exchange at future workgroup and public outreach meetings. It is our sincere desire to support the safe and effective management programs in both the agricultural and urban landscapes. If our organization and/ or specific commodities can be of service in this process, please do not hesitate to contact me.

Respectfully submitted,

Lori Berger, Ph. D. Director of Technical Affairs California Minor Crops Council 4500 S. Lapina Street Suite 214 Tulare, CA 93274 ( 559) 688 5700 lori@ minorcrops. org