[Federal Register Volume 79, Number 23 (Tuesday, February 4, 2014)]
[Notices]
[Pages 6596-6598]
[FR Doc No: 2014-02255]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0053]

Designation of High-Risk Foods for Tracing; Request for Comments
and for Scientific Data and Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments and for scientific data and
information.

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SUMMARY: The Food and Drug Administration (``FDA'' or ``we'') is
announcing the opening of a docket to obtain comments and scientific
data and information that will help us to implement the section of the
FDA Food Safety Modernization Act (FSMA) that requires FDA to designate
high-risk foods. We are providing an opportunity for interested parties
to submit comments and scientific data and information that will help
us develop our process for implementing this provision.

DATES: Submit electronic or written comments and scientific data and
information by April 7, 2014.

ADDRESSES: You may submit comments and scientific data and information,
identified by Docket No. FDA-2014-N-0053, by any of the following
methods:

Electronic Submissions

    Submit electronic comments and scientific data and information in
the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments and scientific data and
information.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2014-N-0053 for this notice. All comments and
scientific data and information received may be posted without change
to http://www.regulations.gov, including any personal information
provided. For additional information on submitting comments and
scientific data and information, see the ``Comments'' heading of the
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
comments and scientific data and information 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 (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Rm 1061, Rockville, MD
20852.

FOR FURTHER INFORMATION CONTACT: Sherri Dennis, Center for Food Safety
and Applied Nutrition (HFS-005), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

A. FDA Food Safety Modernization Act Provision Requiring Designation of
High-Risk Foods

    On January 4, 2011, the President signed the FDA Food Safety
Modernization Act (FSMA) (Pub. L. 111-353) into law. Section 204 of
FSMA requires, among other things, the designation of high-risk foods.
Specifically, section 204(d)(2)(A) of FSMA requires FDA to designate
high-risk foods for which additional recordkeeping requirements are
appropriate and necessary to protect the public health, and to do so
not later than 1 year after the date of enactment of FSMA (and
thereafter, if necessary). Section 204(d)(2)(B) requires FDA to publish
the list of high-risk foods on the Internet Web site of FDA at the time
when FDA issues final rules to establish the additional recordkeeping
requirements for high-risk foods.
    Section 204(d)(2)(A) of FSMA specifically states that the
designation of high-risk foods must be based on the: (1) Known safety
risks of a particular food, including the history and severity of
foodborne illness outbreaks attributed to such food, taking into
consideration foodborne illness data collected by the Centers for
Disease Control and Prevention; (2) likelihood that a particular food
has a high potential risk for microbiological or chemical contamination
or would support the growth of pathogenic microorganisms due to the
nature of the food or the processes used to produce such food; (3)
point in the manufacturing process of the food where contamination is
most likely to occur; (4) likelihood of contamination and steps taken
during the manufacturing process to reduce the possibility of
contamination; (5) likelihood that consuming a particular food will
result in a foodborne illness due to contamination of the food; and (6)
likely or known severity, including health and economic impacts, of a
foodborne illness attributed to a particular food.
    Through this notice, we are establishing a docket to provide an
opportunity for interested parties to provide comments and scientific
data and information that will help us refine our draft approach to
identifying high-risk foods, as required by section 204(d)(2) of FSMA.
Section I.B summarizes our tentative draft approach for the review and
evaluation of data to designate high-risk foods. Attached as a
reference to this notice is a draft approach document in which we
describe the process and methodology we are considering using for
designating high-risk foods. After reviewing comments received in
response to this notice on the draft approach described here, we plan
to further revise the approach as necessary. We also anticipate that
the approach will be reviewed by scientific experts (``peer
reviewed'').
    While section 204(d)(2)(A) of FSMA includes a statutory deadline
within 1 year of the enactment of FSMA, FDA is issuing this notice to
solicit comments and scientific data and information that will help us
refine our draft approach to identifying high-risk foods. In section
II.B, there are a number of specific

topics on which we think various stakeholders and the public at large
could provide valuable comments and scientific data and information to
assist us in implementing section 204 of FSMA. We anticipate that this
input will be critical to our effective implementation of section 204
of FSMA.

B. Draft Approach To Implement Section 204(d)(2) of FSMA--Designation
of High-Risk Foods

    Data and information developed to identify the most significant
foodborne contaminants, including data and information regarding the
number, severity, and related costs of illnesses, may be used as data
inputs for the high-risk foods approach, where applicable and
appropriate.
    The draft approach would use a multicriteria decision analysis
approach, similar to that of Anderson et al., 2011 (Ref. 1), to
identify those foods which should be designated as high-risk. This
approach would use the specific criteria identified in section
204(d)(2)(A) of FSMA and would implement those criteria within a risk
model. For each of the food and hazard pairs identified, we would
determine a total risk score by the weighted sum of the score for each
of the defined criteria. For foods that have multiple risk scores
because they appear in the list associated with more than one hazard,
we would determine the total score for that food using each of the
individual food-hazard pair total risk scores. Inclusion on the high-
risk food list would be based on the total risk score for foods or food
categories. We describe our draft approach, criteria, and scoring
system, and provide examples, in the document entitled ``FDA's Draft
Approach for Designating High-Risk Foods as Required by Section 204 of
FSMA'' (Ref. 2). Although the analysis would encompass food-hazard
pairs, we do not anticipate this to be a food-hazard list but rather a
food list. This draft approach may be further refined pending
stakeholder input in response to this notice.

II. Request for Comments and Scientific Data and Information

    We invite comments on the draft approach outlined in section I.B
and the submission of scientific data and information relevant to high-
risk food designation. We anticipate that this general input, along
with the more specific input we solicit below, will significantly
assist the Agency in fulfilling the requirements of section 204 of
FSMA. In particular, we invite comment, scientific data, and
information on the following topics:
     Considering available data, uncertainty with the data, and
the intended methods, what alternative approaches should we consider to
identify high-risk foods?
     What additional criteria should we consider, within the
bounds of the factors Congress mandated in section 204(d)(2)(A) of
FSMA, to develop the list of high-risk foods? For example, in addition
to the public health related economic impact of foodborne illnesses,
which the draft approach takes into account, should the approach
include nonpublic health economic impact factors, such as costs related
to disruption in the food supply following a foodborne illness
outbreak? If so, how should we determine these costs given the variety
of foods and different market values for various foods?
     What changes should we consider making to the scoring
system to ensure the range of possibilities for the foods and hazards
is comprehensive and to enhance the scoring?
     What changes should we consider making to the approach to
better evaluate risk associated with animal food?
     The draft approach would equally weight the criteria.
Should individual weights be assigned to each criterion? If so, which
criteria should receive more weight and how should those weights be
assigned?
     The draft approach would utilize the food categorization
scheme used for the Reportable Food Registry (Ref. 3). What other
practical alternatives to this food categorization scheme should we
consider in light of the practical constraints of evaluating individual
commodities?
     Adverse reactions may occur when allergic consumers are
exposed to foods that contain undeclared allergens. Undeclared
allergens may be present in a food through either mislabeling or cross-
contact during processing and handling. Both situations present a risk
to allergic consumers because they lead to incomplete or inaccurate
product labels. How should food allergens, including the major food
allergens defined in the Food Allergen Labeling and Consumer Protection
Act of 2004 (Pub. L. 108-282, Title II) (milk, eggs, fish, Crustacean
shellfish, tree nuts, peanuts, wheat, and soybeans), be considered in
the development of the high-risk food list?

C. Additional Information and Data Requested

    We also are interested in the following types of information and
data:
     Scientific data and methods that can be used to assess the
public health impact of acute or chronic exposures to pathogens and
chemical contaminants in human food or animal food. In particular,
scientific data and methods related to chronic exposures to chemical
contaminants in food.
     For representative foods in each food category or
commodity group to be evaluated:
    [cir] A list of the pathogens and chemical contaminants likely to
be found in the food;
    [cir] The percentage prevalence of contaminants in the food;
    [cir] The levels of contaminants in the food;
    [cir] The point in the manufacturing process where the contaminants
are likely to be introduced in the food; and
    [cir] The typical steps and control measures taken in the
manufacturing process to reduce the possibility of contamination of the
food with the pathogen or chemical contaminant.

III. Comments

    Interested persons may submit either electronic comments and
scientific data and information regarding this document to http://www.regulations.gov or written comments to the Division of Dockets
Management (see ADDRESSES). It is only necessary to send one set of
comments and scientific data and information. Identify comments and
scientific data and information with the docket number found in
brackets in the heading of this document. Received comments and
scientific data and information may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday, and will
be posted to the docket at http://www.regulations.gov.

IV. References

    The following references have been placed 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,
and are available electronically at http://www.regulations.gov. (FDA
has verified the Web site addresses in this reference section, but we
are not responsible for any subsequent changes to the Web sites after
this document publishes in the Federal Register).
    1. Anderson, M., Jaykus, L.-A., Beaulieu, S. et al. ``Pathogen-
produce pair attribution risk ranking tool to prioritize fresh
produce commodity and pathogen combinations for further evaluation
(P\3\ARRT).'' Food Control 22, (2011): 1865-1872. 10.1016/
j.foodcont.2011.04.028.
    2. Food and Drug Administration. ``FDA's Draft Approach for
Designating High-Risk Foods as Required by Section 204 of FSMA.''
2013. Available at http://www.fda.gov/

downloads/Food/GuidanceRegulation/FSMA/UCM380212.pdf.
    3. Food and Drug Administration. ``U.S. Food and Drug
Administration, Reportable Food Summary Report, Definitions.''
Available at http://www.fda.gov/downloads/Food/FoodSafety/FoodSafetyPrograms/RFR/UCM211534.pdf. Last Modified April 2012.

    Dated: January 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02255 Filed 2-3-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 86, Number 1 (Monday, January 4, 2021)]
[Notices]
[Pages 100-101]
[FR Doc No: 2020-29044]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1415]

Sunrise Lee: Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing an
order under the Federal Food, Drug, and Cosmetic Act (FD&C Act)
permanently debarring Sunrise Lee from providing services in any
capacity to a person that has an approved or pending drug product
application. FDA bases this order on a finding that Ms. Lee was
convicted of a felony under Federal law for conduct that relates to the
regulation of a drug product under the FD&C Act. Ms. Lee was given
notice of the proposed permanent debarment and an opportunity to
request a hearing to show why she should not be debarred. As of October
8, 2020 (30 days after receipt of the notice), Ms. Lee had not
responded. Ms. Lee's failure to respond and request a hearing
constitutes a waiver of her right to a hearing concerning this action.

DATES: This order is applicable January 4, 2021.

ADDRESSES: Submit applications for termination of debarment to the
Dockets Management Staff, Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>, or at https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, (ELEM-4029) Division
of Enforcement, Office of Strategic Planning and Operational Policy,
Office of Regulatory Affairs, Food and Drug Administration, 12420
Parklawn Dr., Rockville, MD 20857,<PHONE_NUMBER>, or at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B))
requires debarment of an individual from providing services in any
capacity to a person that has an approved or pending drug product
application if FDA finds that the individual has been convicted of a
felony under Federal law for conduct relating to the regulation of any
drug product under the FD&C Act. On January 22, 2020, Ms. Lee was
convicted as defined in section 306(l)(1) of the FD&C Act when judgment
was entered against her in the U.S. District Court for the District of
Massachusetts, after a jury verdict, on one count of Racketeering
Conspiracy in violation of 18 U.S.C. 1962(d). The pattern of
racketeering activity she was convicted of included engaging in
multiple acts of mail fraud (18 U.S.C. 1341) and wire fraud (18 U.S.C.
1343).
    The factual basis for this conviction is as follows: Ms. Lee held
executive management positions, to include Regional Sales Manager for
the Mid-Atlantic Region, Regional Director for the Central Region, and
Regional Director for the West Region, of Insys Therapeutics Inc.
(Insys), a Delaware Corporation, with headquarters in Chandler,
Arizona. Insys developed and owned a drug called SUBSYS, a liquid
formulation of fentanyl to be applied under the tongue. FDA approved
SUBSYS for the management of breakthrough pain in adult cancer patients
who are already receiving and are already tolerant to opioid therapy
for their underlying persistent cancer pain. From 2012 and continuing
through 2015, Ms. Lee participated in a conspiracy whereby employees of
Insys bribed medical practitioners in various states to get those
practitioners to increase prescribing SUBSYS to their patients, many of
whom did not have cancer. Ms. Lee, along with her co-conspirators,
measured the effect of these bribes on each practitioner's prescribing
habits and on the revenue that each bribed practitioner generated for
Insys. Ms. Lee, along with her co-conspirators, reduced or eliminated
bribes paid to those practitioners who failed to meet the minimum
prescription requirements or failed to generate enough revenue to
justify additional bribes. To further this conspiracy, Ms. Lee's co-
conspirators mislead and defrauded health insurance providers to ensure
those providers approved payment for SUBSYS. Insys achieved this goal
by establishing the ``Insys Reimbursement Center,'' which was designed
to shift the burden of seeking prior authorization for SUBSYS from
practitioners to Insys. This allowed Insys to determine what medical
information was presented to insurers. Ms. Lee's co-conspirators
directed Insys employees to mislead insurers to obtain payment
authorization.
    As a result of this conviction, FDA sent Ms. Lee by certified mail
on August 3, 2020, a notice proposing to permanently debar her from
providing services in any capacity to a person that has an approved or
pending drug product application. The proposal was based on a finding,
under section 306(a)(2)(B) of the FD&C Act, that Ms. Lee was convicted
of a felony under Federal law for conduct relating to the regulation of
a drug product under the FD&C Act. The proposal also offered Ms. Lee an
opportunity to request a hearing, providing her 30 days from the date
of receipt of the letter in which to file the request, and advised her
that failure to request a hearing constituted an election not to use
the opportunity for a hearing and a waiver of any contentions
concerning this action. Ms. Lee received the proposal on September 8,
2020. She did not request a hearing within the timeframe prescribed by
regulation and has, therefore, waived her opportunity for a hearing and
any contentions concerning her debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Assistant Commissioner, Office of Human and Animal
Food Operations, under section 306(a)(2)(B) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Ms.
Sunrise Lee has been convicted of a felony under Federal law for
conduct otherwise relating to the regulation of a drug product under
the FD&C Act.
    As a result of the foregoing finding, Ms. Lee is permanently
debarred from providing services in any capacity to a person with an
approved or pending drug product application, effective (see DATES)
(see sections 306(a)(2)(B) and (c)(2)(A)(ii) of the FD&C Act). Any
person with an approved or pending drug product application who
knowingly employs or retains as a consultant or contractor, or
otherwise uses the services of Ms. Lee in any capacity during her
debarment, will be subject to civil money penalties (section 307(a)(6)
of the FD&C Act (21 U.S.C. 335b(a)(6))). If Ms. Lee provides services
in any capacity to a person with an approved or pending drug product
application during her period of debarment, she will be subject to
civil money penalties (section 307(a)(7) of the FD&C Act). In addition,
FDA will not accept or review any abbreviated new drug application from
Ms. Lee during her period of debarment, other than in connection with
an audit under section

306 of the FD&C Act (section 306(c)(1)(B) of the FD&C Act). Note that,
for purposes of section 306 of the FD&C Act, a ``drug product'' is
defined as a drug subject to regulation under section 505, 512, or 802
of the FD&C Act (21 U.S.C. 355, 360b, or 382) or under section 351 of
the Public Health Service Act (42 U.S.C. 262) (section 201(dd) of the
FD&C Act (21 U.S.C. 321(dd))).
    Any application by Ms. Lee for special termination of debarment
under section 306(d)(4) of the FD&C Act should be identified with
Docket No. FDA-2020-N-1415 and sent to the Dockets Management Staff
(see ADDRESSES). The public availability of information in these
submissions is governed by 21 CFR 10.20.
    Publicly available submissions will be placed in the docket and
will be viewable at https://www.regulations.gov or at the Dockets
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday,<PHONE_NUMBER>.

    Dated: December 28, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-29044 Filed 12-31-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 169 (Thursday, September 1, 2022)]
[Rules and Regulations]
[Pages 53654-53656]
[FR Doc No: 2022-18774]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0290; Project Identifier AD-2021-01266-T;
Amendment 39-22109; AD 2022-14-04]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain The Boeing Company Model 787-8, 787-9, and 787-10 airplanes.
This AD was prompted by a report from Boeing that Rolls-Royce
Deutschland Ltd & Co KG (RRD) discovered a design issue in the engine
fuel feed system, which could result in fuel flow restrictions to both
engines when ice that has accumulated in the airplane fuel feed system
suddenly releases into the engines. This AD requires revising the
existing airplane flight manual (AFM) to update the limitations on
minimum fuel temperatures. The FAA is issuing this AD to address the
unsafe condition on these products.

DATES: This AD is effective October 6, 2022.

ADDRESSES:

Examining the AD Docket

    You may examine the AD docket at www.regulations.gov by searching
for and locating Docket No. FAA-2022-0290; or in person at Docket
Operations between 9 a.m. and 5 p.m., Monday through Friday, except
Federal holidays. The AD docket contains this final rule, any comments
received, and other information. The address for Docket Operations is
U.S. Department of Transportation, Docket Operations, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Tak Kobayashi, Aerospace Engineer,
Propulsion Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des
Moines, WA 98198; phone and fax:<PHONE_NUMBER>; email:
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain The Boeing
Company Model 787-8, 787-9, and 787-10 airplanes. The NPRM published in
the Federal Register on April 14, 2022 (87 FR 22158). The NPRM was
prompted by a report from Boeing that RRD discovered a design issue in
the engine fuel feed system, which could result in fuel flow
restrictions to both engines when ice that has accumulated in the
airplane fuel feed system suddenly releases into the engines. In the
NPRM, the FAA proposed to require revising the existing AFM to update
the limitations on minimum fuel temperatures. The FAA is issuing this
AD to address possible fuel flow restrictions to both engines, which
could result in loss of dual engine thrust control and reduced
controllability of the airplane.

Discussion of Final Airworthiness Directive

Comments

    The FAA received no comments on the NPRM or on the determination of
the cost to the public.

Conclusion

    The FAA reviewed the relevant data and determined that air safety
requires adopting this AD as proposed. Except for minor editorial
changes, this AD is adopted as proposed in the NPRM. None of the
changes will increase the economic burden on any operator.

Interim Action

    The FAA considers this AD interim action. Boeing is currently
working with RRD to develop updated electronic engine control (EEC)
software, which will change the engine oil temperature amber line
indicated in the engine indication and crew alerting system (EICAS).
This change will ensure that, before takeoff, the engine oil
temperature would be warm enough to operate the engine with cold fuel.
The updated EEC software combined with the action required by this AD
will address the unsafe condition identified in this AD. Once this
software is developed, approved, and available, the FAA might consider
additional rulemaking.

Costs of Compliance

    The FAA estimates that this AD affects 14 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Revising the existing AFM.............  1 work-hour x $85 per                 $0             $85          $1,190
                                         hour = $85.
----------------------------------------------------------------------------------------------------------------

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.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an

unsafe condition that is likely to exist or develop on products
identified in this rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, 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.

List of Subjects in 14 CFR Part 39

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

The Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

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

2022-14-04 The Boeing Company: Amendment 39-22109; Docket No. FAA-
2022-0290; Project Identifier AD-2021-01266-T.

(a) Effective Date

    This airworthiness directive (AD) is effective October 6, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 787-8, 787-9, and
787-10 airplanes, certificated in any category, with Rolls-Royce
Deutschland Ltd & Co KG Model Trent 1000-A (including -A/01 and -A/
01A), Trent 1000-A2, Trent 1000-AE (including -AE/01A), Trent 1000-
AE2, Trent 1000-AE3, Trent 1000-C (including -C/01 and -C/01A),
Trent 1000-C2, Trent 1000-CE (including -CE/01A), Trent 1000-CE2,
Trent 1000-CE3, Trent 1000-D (including -D/01 and -D/01A), Trent
1000-D2, Trent 1000-D3, Trent 1000-E (including -E/01 and -E/01A),
Trent 1000-E2, Trent 1000-G (including -G/01 and -G/01A), Trent
1000-G2, Trent 1000-G3, Trent 1000-H (including -H/01 and -H/01A),
Trent 1000-H2, Trent 1000-H3, Trent 1000-J2, Trent 1000-J3, Trent
1000-K2, Trent 1000-K3, Trent 1000-L2, Trent 1000-L3, Trent 1000-M3,
Trent 1000-N3, Trent 1000-P3, Trent 1000-Q3, or Trent 1000-R3
engines installed.

(d) Subject

    Air Transport Association (ATA) of America Code 28, Fuel.

(e) Unsafe Condition

    This AD was prompted by a report from Boeing that Rolls-Royce
Deutschland Ltd & Co KG discovered a design issue in the engine fuel
feed system, which could result in fuel flow restrictions to both
engines when ice that has accumulated in the airplane fuel feed
system suddenly releases into the engines. The sudden release of
accumulated ice into the engine fuel feed system, in combination
with low fuel temperatures, could cause freezing temperatures at the
inlet of certain engine fuel feed system components. The FAA is
issuing this AD to address possible fuel flow restrictions to both
engines, which could result in loss of dual engine thrust control
and reduced controllability of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Airplane Flight Manual (AFM) Revision

    Within 30 days after the effective date of this AD, revise the
existing AFM to incorporate the information specified in figure 1 to
paragraph (g) of this AD into the ``Certificate Limitations''
chapter of the applicable Engine Appendix of the existing AFM.
[GRAPHIC] [TIFF OMITTED] TR01SE22.014

(h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle ACO Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or responsible Flight Standards Office,
as appropriate. If sending information directly to the manager of
the certification office, send it to the attention of the person
identified in paragraph (i) of this AD. Information may be emailed
to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the responsible Flight Standards Office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by The Boeing Company Organization Designation
Authorization (ODA) that has been authorized by the

Manager, Seattle ACO Branch, FAA, to make those findings. To be
approved, the repair method, modification deviation, or alteration
deviation must meet the certification basis of the airplane, and the
approval must specifically refer to this AD.

(i) Related Information

    For more information about this AD, contact Tak Kobayashi,
Aerospace Engineer, Propulsion Section, FAA, Seattle ACO Branch,
2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-
3553; email: [email protected].

(j) Material Incorporated by Reference

    None.

    Issued on June 24, 2022.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2022-18774 Filed 8-31-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 124 (Monday, June 29, 2015)]
[Rules and Regulations]
[Page 36914]
[FR Doc No: 2015-15930]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2013-0327]

Regattas and Marine Parades in the COTP Lake Michigan Zone--
Chinatown Chamber of Commerce Dragon Boat Race, Chicago, IL

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce the special local regulation on
the South Branch of the Chicago River for the Chinatown Chamber of
Commerce Dragon Boat Race in Chicago, Illinois. This regulated area
will be enforced from 8 a.m. until 5 p.m. on June 27, 2015. This action
is necessary and intended to ensure safety of life and property on
navigable waters immediately prior to, during, and immediately after
the Dragon Boat race. During the aforementioned period, the Coast Guard
will enforce restrictions upon, and control movement of, vessels in a
portion of the Captain of the Port Lake Michigan Zone.

DATES: The regulations in 33 CFR 100.909 will be enforced from 8 a.m.
until 5 p.m. on June 27, 2015.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
document, call or email MST1 John Ng, Waterways Management Division,
Marine Safety Unit Chicago, at<PHONE_NUMBER>, email address
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the special
local regulation listed in 33 CFR 100.909, Chinatown Chamber of
Commerce Dragon Boat Race; Chicago, IL. This special local regulation
will encompass all waters of the South Branch of the Chicago River from
the West 18th Street Bridge at position 41[deg]51'28'' N.,
087[deg]38'06'' W. to the Amtrak Bridge at position 41[deg]51'20'' N.,
087[deg]38'13'' W. (NAD 83). This special local regulation will be
enforced from 8 a.m. until 5 p.m. on June 27, 2015.
    Vessels desiring to transit the regulated area may do so only with
prior approval of the Patrol Commander and when so directed by that
officer. Vessels will be operated at a no wake speed to reduce wake to
a minimum, and in a manner which will not endanger participants in the
event or any other craft. The rules contained in the above two
sentences shall not apply to participants in the event or vessels of
the patrol operating in the performance of their assigned duties. The
Patrol Commander may direct the anchoring, mooring, or movement of any
boat or vessel within the regatta area.
    This document is issued under authority of 33 CFR 100.909,
Chinatown Chamber of Commerce Dragon Boat Race; Chicago, IL, and 5
U.S.C. 552(a). In addition to this notification in the Federal
Register, the Coast Guard will provide the maritime community with
advance notification of the enforcement of this special local
regulation via Broadcast Notice to Mariners or Local Notice to
Mariners. The Captain of the Port Lake Michigan, or a designated on-
scene representative may be contacted via Channel 16, VHF-FM.

    Dated: June 11, 2015.
A.B. Cocanour,
Captain, U.S. Coast Guard, Captain of the Port, Lake Michigan.
[FR Doc. 2015-15930 Filed 6-26-15; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: November 9, 2009 (Volume 74, Number 215)]
[Notices]
[Page 57734-57735]
[DOCID:fr09no09-103]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2009-0169; Notice 1]

Receipt of Petition for Decision That Nonconforming 1994-1999
Bimota SB6 Motorcycles Are Eligible for Importation

AGENCY: National Highway Traffic Safety Administration, DOT.

ACTION: Notice of receipt of petition for decision that nonconforming
1994-1999 Bimota SB6 motorcycles are eligible for importation.

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

SUMMARY: This document announces receipt by the National Highway
Traffic Safety Administration (NHTSA) of a petition for a decision that
1994-1999 Bimota SB6 motorcycles that were not originally manufactured
to comply with all applicable Federal motor vehicle safety standards
(FMVSS) are eligible for importation into the United States because (1)
they are substantially similar to vehicles that were originally
manufactured for sale in the United States and that were certified by
their manufacturer as complying with the safety standards, and (2) they
are capable of being readily altered to conform to the standards.

DATE: The closing date for comments on the petition is December 9,
2009.

ADDRESSES: Comments should refer to the docket and notice numbers above
and be submitted by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility: U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., between 9 a.m. and 5 p.m. ET,
Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Instructions: Comments must be written in the English language, and
be no greater than 15 pages in length, although there is no limit to
the length of necessary attachments to the comments. If comments are
submitted in hard copy form, please ensure that two copies are
provided. If you wish to receive confirmation that your comments were
received, please enclose a stamped, self-addressed postcard with the
comments. Note that all comments received will be posted without change
to http://www.regulations.gov, including any personal information
provided. Please see the Privacy Act heading below.
    Privacy Act: Anyone is able to search the electronic form of all
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 DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    How to Read Comments submitted to the Docket: You may read the
comments received by Docket Management at the address and times given
above. You may also view the documents from the Internet at http://
www.regulations.gov. Follow the online instructions for accessing the
dockets. The docket ID number and title of this notice are shown at the
heading of this document notice. Please note that even after the
comment closing date, we will continue to file relevant information in
the Docket as it becomes available. Further, some people may submit
late comments. Accordingly, we recommend that you periodically search
the Docket for new material.

FOR FURTHER INFORMATION CONTACT: Coleman Sachs, Office of Vehicle
Safety Compliance, NHTSA<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 30141(a)(1)(A), a motor vehicle that was not
originally manufactured to conform to all applicable FMVSS shall be
refused admission into the United States unless NHTSA has decided that
the motor vehicle is substantially similar to a motor vehicle
originally manufactured for sale in the United States, certified under
49 U.S.C. 30115, and of the same model year as the model of the motor
vehicle to be compared, and is capable of being readily altered to
conform to all applicable FMVSS.
    Petitions for eligibility decisions may be submitted by either
manufacturers or importers who have registered with NHTSA pursuant to
49 CFR Part 592. As specified in 49 CFR 593.7, NHTSA publishes notice
in the Federal Register of each petition that it receives, and affords
interested persons an opportunity to comment on the petition. At the
close of the comment period, NHTSA decides, on the basis of the
petition and any comments that it has received, whether the vehicle is
eligible for importation. The agency then publishes this decision in
the Federal Register.
    US SPECS, LLC (``US SPECS''), of Havre de Grace, Maryland
(Registered Importer 03-321) has petitioned NHTSA to decide whether
non-U.S. certified 1994-1999 Bimota SB6 motorcycles are eligible for
importation into the United States. The vehicles that US SPECS believes
are substantially similar are 1994-1999 Bimota SB6 motorcycles that
were manufactured for sale in the United States and certified by their
manufacturer as conforming to all applicable FMVSS.
    The petitioner claims that it carefully compared non-U.S. certified
1994-1999 Bimota SB6 motorcycles to their U.S. certified counterparts,
and found the vehicles to be substantially similar with respect to
compliance with most FMVSS.
    US SPECS submitted information with its petition intended to
demonstrate that non-U.S. certified 1994-1999 Bimota SB6 motorcycles,
as originally manufactured, conform to many FMVSS in the same manner as
their U.S. certified counterparts, or are capable of being readily
altered to conform to those standards.
    Specifically, the petitioner claims that non-U.S. certified 1994-
1999 Bimota SB6 motorcycles are identical to their U.S. certified
counterparts with respect to compliance with Standard Nos. 116 Brake
Fluid, 119 New Pneumatic Tires for Vehicles other than Passenger Cars,
and 122 Motorcycle Brake Systems.
    The petitioner further contends that the vehicles are capable of
being readily altered to meet the following standards, in the manner
indicated below:
    Standard No. 106 Brake Hoses: inspection of all vehicles, and
replacement of noncompliant brake hoses with U.S.-certified components
on vehicles that are not already so equipped.
    Standard No. 108 Lamps, Reflective Devices and Associated
Equipment: Installation of the following U.S.-certified components on
vehicles not already so equipped: (a) Headlamp; (b) front and rear
side-mounted reflex reflectors; (c) rear-mounted reflex reflector; (d)
turn signal lamps; and (e) taillamp.
    Standard No. 111 Rearview Mirrors: Inspection of all vehicles, and
replacement of noncompliant mirrors with U.S.-conforming components on
vehicles that are not already so equipped.
    Standard No. 120 Tire Selection and Rims for Vehicles other than
Passenger Cars: Installation of a tire information placard.

    Standard No. 123 Motorcycle Controls and Displays: Installation of
a U.S.-model speedometer, or modification of the existing speedometer
to conforms with the requirements of this standard.
    Standard No. 205 Glazing Materials: Inspection of all vehicles, and
removal of noncompliant glazing or replacement of the glazing with
U.S.-certified components on vehicles that are not already so equipped.
    All comments received before the close of business on the closing
date indicated above will be considered, and will be available for
examination in the docket at the above addresses both before and after
that date. To the extent possible, comments filed after the closing
date will also be considered. Notice of final action on the petition
will be published in the Federal Register pursuant to the authority
indicated below.

    Authority: 49 U.S.C. 30141(a)(1)(A) and (b)(1); 49 CFR 593.8;
delegations of authority at 49 CFR 1.50 and 501.8.

    Issued on: November 3, 2009.
Claude H. Harris,
Director, Office of Vehicle Safety Compliance.
[FR Doc. E9-26965 Filed 11-6-09; 8:45 am]

BILLING CODE 4910-59-P


[Federal Register: December 13, 2007 (Volume 72, Number 239)]
[Notices]
[Page 70914-70915]
[DOCID:fr13de07-109]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56919; File No. SR-ISE-2007-114]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change Relating to Fee Changes

December 6, 2007.
    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 3, 2007, the International Securities Exchange, LLC
(``Exchange'' or ``ISE'') 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 substantially
prepared by the ISE. The ISE has designated this proposal as one
establishing or changing a due, fee, or other charge imposed by the
CBOE under section 19(b)(3)(A)(ii) of the Act,\3\ and Rule 19b-4(f)(2)
thereunder,\4\ which renders the proposal effective upon filing with
the Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    The ISE is proposing to amend its Schedule of Fees to establish
fees for transactions in options on 1 Premium Product.\5\ The text of
the proposed rule change is available on the ISE's Web site (http://www.ise.com
), at the principal office of the ISE, and at the

Commission's Public Reference Room.
---------------------------------------------------------------------------

    \5\ ``Premium Products'' is defined in the Schedule of Fees as
the products enumerated therein.
---------------------------------------------------------------------------

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

    In its filing with the Commission, the ISE 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 ISE has prepared summaries, set forth in sections A,
B, and C below, of the most significant aspects of such statements.

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

1. Purpose
    The Exchange is proposing to amend its Schedule of Fees to
establish fees for transactions in options on the PowerShares Golden
Dragon Halter USX China Portfolio (``PGJ'').\6\ The Exchange represents
that PGJ \7\ is eligible for options trading because it constitutes
``Fund Shares,'' as defined by ISE Rule 502(h).
---------------------------------------------------------------------------

    \6\ PowerSharesTM and PGJTM are trademarks
of PowerShares Capital Management LLC (``PowerShares'' or the
``Adviser''). Halter Financial Group, Inc. (``Halter Financial'') is
the index provider for the Golden Dragon Halter USX China Portfolio
(``PGJ''). The ``USX China Index'' is a trademark of Halter
Financial and has been licensed for use for certain purposes by the
Adviser. All other trademarks and service marks are the property of
their respective owners. PGJ is not sponsored, endorsed, sold or
promoted by Halter Financial, and Halter Financial makes no
representation regarding the advisability of investing in PGJ.
Halter Financial and PowerShares have not licensed or authorized ISE
to (i) engage in the creation, listing, provision of a market for
trading, marketing, and promotion of options on PGJ or (ii) to use
and refer to any of their trademarks or service marks in connection
with the listing, provision of a market for trading, marketing, and
promotion of options on PGJ or with making disclosures concerning
options on PGJ under any applicable federal or state laws, rules or
regulations. Halter Financial and PowerShares do not sponsor,
endorse, or promote such activity by ISE, and are not affiliated in
any manner with ISE.
    \7\ The Exchange inadvertently included a reference to ILF
options and requested that the Commission correct this error.
Telephone conversation between Samir Patel, Assistant General
Counsel, CBOE, and Sonia Trocchio, Special Counsel, Division of
Trading and Markets, Commission (December 6, 2007).
---------------------------------------------------------------------------

    All of the applicable fees covered by this filing are identical to
fees charged by the Exchange for all other Premium Products.
Specifically, the Exchange is proposing to adopt an execution fee and a
comparison fee for all transactions in options on PGJ.\8\ The amount of
the execution fee and comparison fee for products covered by this
filing shall be $0.15 and $0.03 per contract, respectively, for all
Public Customer Orders \9\ and Firm Proprietary orders. The amount of
the execution fee and comparison fee for all ISE Market Maker
transactions shall be equal to the execution fee and comparison fee

currently charged by the Exchange for ISE Market Maker transactions in
equity options.\10\ Finally, the amount of the execution fee and
comparison fee for all non-ISE Market Maker transactions shall be $0.37
and $0.03 per contract, respectively.\11\ Further, since options on PGJ
are multiply-listed, the Payment for Order Flow fee shall apply to this
product. The Exchange believes the proposed rule change will further
the Exchange's goal of introducing new products to the marketplace that
are competitively priced.
---------------------------------------------------------------------------

    \8\ These fees will be charged only to Exchange members. Under a
pilot program that is set to expire on July 31, 2008, these fees
will also be charged to Linkage Orders (as defined in ISE Rule
1900). See Securities Exchange Act Release No. 56128 (July 24,
2007), 72 FR 42161 (August 1, 2007) (SR-ISE-2007-55).
    \9\ ``Public Customer Order'' is defined in Exchange Rule
100(a)(39) as an order for the account of a Public Customer.
``Public Customer'' is defined in Exchange Rule 100(a)(38) as a
person that is not a broker or dealer in securities.
    \10\ The execution fee is currently between $.21 and $.12 per
contract side, depending on the Exchange Average Daily Volume, and
the comparison fee is currently $.03 per contract side.
    \11\ The amount of the execution and comparison fee for non-ISE
Market Maker transactions executed in the Exchange's Facilitation
and Solicitation Mechanisms is $0.16 and $0.03 per contract,
respectively.
---------------------------------------------------------------------------

2. Statutory Basis
    The basis under the Act for this proposed rule change is the
requirement under section 6(b)(4) of the Act \12\ that an exchange have
an equitable allocation of reasonable dues, fees and other charges
among its members and other persons using its facilities.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

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

    Because the foregoing rule change establishes or changes a due,
fee, or other charge imposed by the Exchange, it has become effective
pursuant to section 19(b)(3) of the Act \13\ and Rule 19b-4(f)(2) \14\
thereunder. At any time within 60 days of the filing of such proposed
rule change, the Commission may summarily abrogate such rule change if
it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 17 CFR 19b-4(f)(2).
---------------------------------------------------------------------------

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 E-mail to<EMAIL_ADDRESS>Please include

File No. SR-ISE-2007-114 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2007-114. This file
number should be included on the subject line if e-mail 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 Web site (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 inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the ISE. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-ISE-2007-114 and should be
submitted on or before January 3, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-24088 Filed 12-12-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 31 (Wednesday, February 14, 2018)]
[Notices]
[Pages 6624-6626]
[FR Doc No: 2018-02977]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82662; File No. SR-DTC-2017-024]

Self-Regulatory Organizations; The Depository Trust Company;
Order Approving Proposed Rule Change To Amend Procedures in the DTC
Settlement Service Guide Relating to the Intra-Month Collection of
Required Participants Fund Deposits

February 8, 2018.
    On December 22, 2017, the Depository Trust Corporation (``DTC'')
filed with the Securities and Exchange Commission (``Commission'')
proposed rule change SR-DTC-2017-024, pursuant to Section 19(b)(1) of
the Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder.\2\ The proposed rule change was published for comment in
the Federal Register on January 9, 2018.\3\ The Commission did not
receive any comment letters on the proposed rule change. For the
reasons discussed below, the Commission approves the proposed rule
change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 82434 (January 3, 2018),
83 FR 1046 (January 9, 2018) (SR-DTC-2017-024) (``Notice'').
---------------------------------------------------------------------------

I. Description of the Proposed Rule Change

    The proposed rule change would amend DTC's Settlement Service Guide
(``Guide'') \4\ to (1) codify more completely DTC's current practices
regarding when a DTC participant (``Participant'') \5\ must deposit
cash at DTC to satisfy an intra-month deficiency in the Participant's
required contribution to DTC's Participants Fund \6\ (``Deficiency''),
and (2) make technical and clarifying changes to the Guide, as more
fully described below.
---------------------------------------------------------------------------

    \4\ Available at https://www.dtcc.com/~/media/Files/Downloads/
legal/service-guides/Settlement.pdf.
    \5\ ``Participant'' is defined in the DTC Rules, Bylaws,
Organization Certificate (``Rules'') as an entity to which DTC
offers its services pursuant to the Rules, available at http://www.dtcc.com/legal/rules-and-procedures?pgs=1.
    \6\ The Participants Fund is the fund in which DTC collects and
holds cash from Participants in order to maintain sufficient
liquidity resources in the event of a Participant default. Notice,
83 FR at 1047.
---------------------------------------------------------------------------

A. Background

    DTC requires Participants to contribute an aggregate amount of
$1.15 billion to the Participants Fund.\7\ That amount is collected
through two components of the Participants Funds, the Core Fund and the
Liquidity Fund, to which Participants must contribute, as
applicable.\8\
---------------------------------------------------------------------------

    \7\ Guide, supra note 4 at 48; Notice, 83 FR at 1047.
    \8\ See Guide, supra note 4 at 48-50 (explaining the components
of the Participants Fund); see also Notice, 83 FR at 1047.
---------------------------------------------------------------------------

    DTC sets the total value of the Core Fund at $450 million, which is
collected through two underlying funds: The Base Fund and the
Incremental Fund.\9\ Each Participant is required to contribute a
minimum of $7,500 to the Base Fund.\10\ Meanwhile, the Incremental Fund
makes up the difference, if any, between the aggregate amount collected
in the Base Fund and the total $450 million of the Core Fund. If there
is a difference, DTC allocates the difference proportionally among all
Participants.\11\
---------------------------------------------------------------------------

    \9\ See Guide, supra note 4 at 48.
    \10\ Id.; Notice, 83 FR at 1047.
    \11\ Guide, supra note 4 at 48. A Participant's contribution to
the Incremental Fund is based on the average of the Participant's
six largest intra-day liquidity exposures at DTC, over a rolling 60-
business-day period. Id.; Notice, 83 FR at 1047.
---------------------------------------------------------------------------

    DTC sets the total value of the Liquidity Fund at $700 million.\12\
The Liquidity Fund is allocated proportionately among Participants with
affiliated families,\13\ where the affiliated families have been
authorized by DTC to have over $2.15 billion in intraday debits.\14\
---------------------------------------------------------------------------

    \12\ Guide, supra note 4 at 49.
    \13\ The Rules define an ``affiliated family'' as each
Participant that controls (or is controlled by another Participant
that has) direct or indirect ownership of more than 50 percent of
the voting securities (or voting interests) of another Participant,
and each such Participant is under the common control of the same
entity. Supra note 5 at 2.
    \14\ Guide, supra note 4 at 49; Notice, 83 FR at 1047.
---------------------------------------------------------------------------

    The aggregate amount that a Participant is required to contribute
to the Participants Fund is the Participant's Required Participants
Fund Deposit (hereinafter, ``Required Deposit'').\15\ In addition,
Participants may make voluntary deposits to the Participants Fund,
which DTC refers to as Voluntary Participants Fund Deposits
(hereinafter, ``Voluntary Deposit'').\16\ A Participant may choose to
make a Voluntary Deposit in anticipation of

potential increases to its Required Deposit.\17\
---------------------------------------------------------------------------

    \15\ Guide, supra note 4 at 47-48; Notice, 83 FR at 1047.
    \16\ Guide, supra note 4 at 47; Notice, 83 FR at 1047.
    \17\ Notice, 83 at 1047. A Participant's Required Deposit may
fluctuate based on the liquidity exposure associated with the
Participant's settlement activity. See Guide, supra note 4 at 51.
The Guide provides that when a Participant's Required Deposit has
decreased, the Participant may choose to leave excess cash in the
Participants Fund to reduce the level of administration that would
otherwise be necessary should the Participant's Required Deposit
later increase. Id. DTC also accepts Voluntary Deposits for such
administrative purposes. Id.
---------------------------------------------------------------------------

    A Participant's deposits to the Participants Fund, including both
Required Deposits and Voluntary Deposits, if any, are considered the
Participant's Actual Participants Fund Deposits (hereinafter, ``Actual
Deposits'').\18\ DTC can use a Participant's Actual Deposits to cover
losses associated with the Participant's default.\19\
---------------------------------------------------------------------------

    \18\ Notice, 83 FR at 1047.
    \19\ Id.
---------------------------------------------------------------------------

    DTC calculates the Required Deposit of each Participant on a daily
basis.\20\ However, DTC states that Required Deposits generally do not
materially change on a daily basis because the calculation uses a 60-
business-day rolling average.\21\ Therefore, DTC generally only
collects funds to cover a Deficiency, if any, on a monthly basis--
specifically, on the last business day of the month.\22\
---------------------------------------------------------------------------

    \20\ Id.
    \21\ Id.
    \22\ Id.
---------------------------------------------------------------------------

    Notwithstanding the above, DTC will require a Participant to
satisfy an intra-month Deficiency if, when considering the Reference
Amount, described below, the Deficiency meets or exceeds either the
Standard Threshold or the Watch List Threshold, also described below.
    The Reference Amount is the most recent Required Deposit amount
that the Participant deposited to the Participants Fund, as compared to
the Required Deposit amount that DTC calculates on a daily basis but
does not necessarily require an intra-month deposit.\23\ More
specifically, the Reference Amount is the amount that the Participant
deposited to the Participants Fund based upon a Required Deposit as
calculated on (1) the last business day of the prior month, (2) the
most recent intra-month business day when the Participant's Deficiency
met or exceeded the Standard Threshold or the Watch List Threshold, as
described below, or (3) the most recent intra-month business day when
DTC collected an ``adequate assurance'' charge under Rule 9(A) of the
Rules.\24\
---------------------------------------------------------------------------

    \23\ See Guide, supra note 4 at 50-51 (explaining daily
calculations of the Required Deposit); see also Notice, 83 FR at
1048.
    \24\ Notice, 83 FR at 1048. Pursuant to Rule 9(A) of the Rules,
if DTC is concerned with a Participant's operational or financial
soundness, DTC may require adequate assurances of financial or
operational capacity from the Participant. Id.; see also Rules,
supra note 5, Rule 9(A), Section 2 (stating ``At the request of
[DTC],'' a Participant ``shall immediately furnish [DTC] with such
assurances as [DTC] shall require of the financial ability of the
Participant . . . including deposits to the Participants Fund'').
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    The Standard Threshold for determining when a Participant must
satisfy an intra-month Deficiency is when (1) the difference between
the Participant's current Required Deposit calculation and the
Reference Amount equals or exceeds $500,000 and (2) the difference is
at least a 25 percent increase over the Reference Amount.\25\
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    \25\ Notice, 83 FR at 1048.
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    The Watch List Threshold for determining when a Participant must
satisfy an intra-month Deficiency is when (1) the Participant is on
DTC's ``Watch List'' \26\ and (2) the difference between the
Participant's current Required Deposit calculation and the Reference
Amount is at least a 10 percent increase over the Reference Amount.\27\
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    \26\ Notice, 83 FR at 1048. The Watch List is a list of
Participants with credit risk rating of ``5,'' ``6,'' or ``7,'' as
calculated by DTC's Credit Risk Rating Matrix, as well as
Participants that, based on DTC's consideration of relevant factors,
are deemed by DTC to pose a heightened risk to DTC and its
Participants. Id. at 1047. These factors include (i) quantitative
factors, such as capital, assets, earnings, and liquidity, and (ii)
qualitative factors, such as management quality, market position/
environment, and capital and liquidity risk management. Id.
    \27\ Id. at 1048-49.
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B. Proposed Changes to the Guide

    The Guide currently does not define the Reference Amount used for
the purpose of determining the Standard Threshold and Watch List
Threshold, nor does the Guide describe the Watch List Threshold.\28\ As
such, DTC proposes to codify in the Guide its current processes for (1)
determining the Reference Amount for each Participant and (2) applying
the Watch List Threshold, as described above.\29\
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    \28\ Id. at 1047.
    \29\ Id.
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    DTC also proposes to modify the Guide to (1) revise and re-order
text for enhanced readability and flow of content, (2) add subheadings,
(3) revise informal references to terms already defined in the Rules to
use the actual defined terms, and (4) make grammatical corrections.\30\
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    \30\ Id. at 1049.
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II. Discussion and Commission Findings

    Section 19(b)(2)(C) of the Act \31\ directs the Commission to
approve a proposed rule change of a self-regulatory organization if it
finds that such proposed rule change is consistent with the
requirements of the Act and rules and regulations thereunder applicable
to such organization. The Commission believes the proposal is
consistent with Act, specifically Section 17A(b)(3)(F) of the Act and
Rule 17Ad-22(e)(23)(ii) under the Act.\32\
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    \31\ 15 U.S.C. 78s(b)(2)(C).
    \32\ 15 U.S.C. 78q-1(b)(3)(F); 17 CFR 240.17Ad-22(e)(23)(ii).
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    Section 17A(b)(3)(F) of the Act requires, in part, that the rules
of the clearing agency be designed to assure the safeguarding of
securities and funds which are in the custody or control of the
clearing agency or for which it is responsible.\33\ As described above,
the proposed rule change would codify DTC's practices regarding the
Reference Amount and the Watch List Threshold. By adding these
provisions to the Guide, the Guide would provide greater transparency
to Participants regarding the criteria DTC uses to determine whether a
Participant must increase its Required Deposit on an intra-month basis
because of a Deficiency.
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    \33\ 15 U.S.C. 78q-1(b)(3)(F).
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    By providing Participants with such enhanced transparency, the
proposal is designed to enable Participants to better anticipate when
an intra-month deposit may be necessary. This increased foresight would
help improve the likelihood that Participants are ready and able to
make the deposit. As such, the proposal would help ensure that the
Participants Fund is adequately funded and, thus, the appropriate
amount of Actual Deposits is available to DTC, if it should need to
manage a Participant default. Therefore, the Commission finds that the
proposed rule change would help assure the safeguarding of securities
and funds which are in the custody or control of DTC or for which it is
responsible, consistent with Section 17A(b)(3)(F) of the Act.\34\
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    \34\ Id.
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    Section 17A(b)(3)(F) of the Act also requires, in part, that the
rules of the clearing agency be designed to promote the prompt and
accurate clearance and settlement of securities transactions.\35\ As
described above, the proposed rule change also includes technical and
clarifying changes to the text of the Guide that would enhance
readability, make grammatical corrections, and add new section
headings. These changes

would increase the precision and clarity of the Guide. This increased
precision and clarity would help facilitate Participants' ability to
better understand their respective rights and obligations regarding
DTC's clearance and settlement of securities transactions. Accordingly,
the Commission finds that the proposed changes would promote the prompt
and accurate clearance and settlement of securities transactions,
consistent with the requirements of Section 17A(b)(3)(F) of the
Act.\36\
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    \35\ Id.
    \36\ Id.
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    Rule 17Ad-22(e)(23)(ii) under the Act requires DTC to establish,
implement, maintain and enforce written policies and procedures
reasonably designed to provide sufficient information to enable
Participants to identify and evaluate the risks and material costs they
incur by participating in DTC.\37\ As described above, the proposed
rule change would (1) increase the Guide's transparency regarding DTC's
procedures for the intra-month calculation of Required Deposits and (2)
make other technical and clarifying changes to increase the Guide's
readability. Increased transparency around a Participant's required
intra-month deposit to the Participants Fund to satisfy a Deficiency,
as well as the increased clarity in the readability of the Guide, are
each changes that are designed to provide Participants with sufficient
information to identify and evaluate risks and material costs in
connection with their Required Deposit as participants of DTC.
Therefore, the Commission finds that the proposed rule change is
consistent with Rule 17Ad-22(e)(23)(ii).\38\
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    \37\ 17 CFR 240.17Ad-22(e)(23)(ii).
    \38\ Id.
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III. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposal is consistent with the requirements of the Act, in particular
the requirements of Section 17A of the Act \39\ and the rules and
regulations thereunder.
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    \39\ 15 U.S.C. 78q-1.
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    It is therefore ordered, pursuant to Section 19(b)(2) of the Act,
that proposed rule change SR-DTC-2017-024 be, and hereby is,
approved.\40\
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    \40\ In approving the proposed rule change, the Commission
considered the proposals' impact on efficiency, competition, and
capital formation. 15 U.S.C. 78c(f).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\41\
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    \41\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-02977 Filed 2-13-18; 8:45 am]
 BILLING CODE 8011-01-P