[Federal Register Volume 83, Number 131 (Monday, July 9, 2018)]
[Rules and Regulations]
[Page 31659]
[FR Doc No: 2018-14616]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2018-0639]

Drawbridge Operation Regulation; Black Narrows and Lewis Creek
Channel, Chincoteague Island, VA

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the SR 175 Bridge, which carries SR 175
across the Black Narrows and Lewis Creek Channel, mile 0.0, at
Chincoteague Island, VA. The deviation is necessary to facilitate the
2018 Annual Pony Run and Auction. This deviation allows the bridge to
remain in the closed-to-navigation position.

DATES: The deviation is effective from 6 a.m. on July 25, 2018, through
6 p.m. on July 26, 2018.

ADDRESSES: The docket for this deviation, USCG-2018-0639 is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH''. Click on Open Docket Folder on the line
associated with this deviation.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Mr. Michael Thorogood, Bridge
Administration Branch Fifth District, Coast Guard, telephone 757-398-
6557, email [email protected].

SUPPLEMENTARY INFORMATION: The Virginia Department of Transportation,
owner and operator of the SR 175 Bridge that carries SR 175 across the
Black Narrows and Lewis Creek Channel, mile 0.0, at Chincoteague
Island, VA, has requested a temporary deviation from the current
operating regulations to ensure the safety of the participants and
spectators associated with the 2018 Annual Pony Run and Auction on July
25, 2018, and July 26, 2018. This bridge is a single-span bascule
drawbridge, with a vertical clearance of 15 feet above mean high water
in the closed position and unlimited vertical clearance in the open
position.
    The current operating regulation is set out in 33 CFR 117.5. Under
this temporary deviation, the bridge will be maintained in the closed-
to-navigation position from 6 a.m. through 6 p.m. on July 25, 2018, and
July 26, 2018.
    The Black Narrows and Lewis Creek Channel is used by a variety of
vessels including recreational vessels. The Coast Guard has carefully
coordinated the restrictions with waterway users in publishing this
temporary deviation.
    Vessels able to pass through the bridge in the closed-to-navigation
position may do so at anytime. The bridge will not be able to open for
emergencies and there is no immediate alternative route for vessels
unable to pass through the bridge in the closed position. The Coast
Guard will also inform the users of the waterway through our Local and
Broadcast Notices to Mariners of the change in operating schedule for
the bridge so that vessel operators can arrange their transits to
minimize any impact caused by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: July 2, 2018.
Hal R. Pitts,
Bridge Program Manager, Fifth Coast Guard District.
[FR Doc. 2018-14616 Filed 7-6-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 87, Number 26 (Tuesday, February 8, 2022)]
[Notices]
[Pages 7186-7187]
[FR Doc No: 2022-02617]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2005-N-0101]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Prescription Drug
User Fee Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Submit written comments (including recommendations) on the
collection of information by March 10, 2022.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0297. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

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

Prescription Drug User Fee Program

OMB Control Number 0910-0297--Revision

    This information collection supports implementation of the Food and
Drug Administration Prescription Drug User Fee Act (PDUFA) program.
PDUFA was enacted in 1992 and authorizes FDA to collect fees from
companies that produce certain human drug and biological products.
Under the prescription drug user fee provisions of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (sections 735 and 736 (21 U.S.C. 379g
and 379h)), we have the authority to assess and collect user fees for
certain new drug applications (NDAs) and new biologics license
applications (BLAs). Under this authority, pharmaceutical companies pay
a fee for certain new NDAs and BLAs submitted to FDA for review. We
have established a PDUFA page on our website at https://www.fda.gov/forindustry/userfees/prescriptiondruguserfee/ that includes resources
and information regarding PDUFA topics at FDA.
    Because the submission of user fees concurrently with applications
is required, review of an application by FDA cannot begin until the fee
is submitted. To assist respondents in this regard, we developed Form
FDA 3397 entitled ``PDUFA Cover Sheet.'' Additional information and
associated instructions may be found on our website at https://www.fda.gov/industry/fda-user-fee-programs. The cover sheet (Form FDA
3397) need not be submitted for certain FDA-regulated products, e.g.,
generic drugs, and whole blood and blood components for transfusion.
The list of exempted products is included under the instructions to
Form FDA 3397. Relatedly, sections 735 and 736 of the FD&C Act also
provide for waiver, reduction, refund, and reconsideration requests. We
developed the guidance document entitled ``Guidance for Industry--
Prescription Drug User Fee Act Waivers, Reductions, and Refunds for
Drug and Biological Products,'' and Form FDA 3971 (Small Business
Waiver and Refund Request), which can be found on our website at
https://www.fda.gov/media/131797/download.
    We are revising the collection to include our current commitment
goals, as set forth in the document ``PDUFA Reauthorization Performance
Goals and Procedures Fiscal Years 2018 Through 2022,'' also found on
our website at https://www.fda.gov/media/99140/download. PDUFA is
currently authorized through September 30, 2022, with reauthorization
activities currently underway. The commitment goals represent the
product of FDA's discussions with the regulated industry and public
stakeholders, as mandated by Congress. FDA is committed to meeting
these goals and to continuous

operational improvements associated with PDUFA implementation. The
commitment goals provide for the development and issuance of topic-
specific guidance. We maintain a searchable guidance database on our
website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. In publishing the respective notices of
availability for each guidance document, we include an analysis under
the PRA and invite public comment on the associated information
collection recommendations. In addition, all Agency guidance documents
are issued in accordance with our good guidance practice regulations in
21 CFR 10.115, which provide for public comment at any time.
    In the Federal Register of November 30, 2021 (86 FR 67958), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    We estimate the burden of the collection of information as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
   Prescription drug user fee        Number of     responses per   Total annual   Average burden    Total hours
            activity                respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Sections 735 and 736 of the FD&C             112            1.68             189              17           3,213
 Act (PDUFA waivers, not
 including small business
 waivers).......................
Section 736(d)(1)(C) of the FD&C              37               1              37               2              74
 Act and Form FDA 3971 (small
 business waivers)..............
Reconsideration Requests........               6            1.67              10              24             240
Appeal Requests.................               1               1               1              12              12
User Fee Cover Sheet Form FDA                174               1             174         0.5 (30              87
 3397...........................                                                        minutes)
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............             411  ..............            3626
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on a review of Agency records, we estimate that the number of
initial waiver requests submitted annually (excluding small business
waiver requests under section 736(d)(1)(C)) of the FD&C Act) will be
189, submitted by 112 different applicants; and that 37 respondents
annually will each submit a small business waiver request. We have
included in the burden estimate the time for preparation and submission
of application fee waivers for small businesses, including completion
of Form FDA 3971. Small businesses requesting a waiver must submit
documentation to FDA, including the number of their employees, as well
as information that the application is the first human drug
application, within the meaning of the FD&C Act, to be submitted to the
Agency for approval.
    We estimate receiving 10 requests for reconsideration annually
(including small business waiver reconsiderations) and assume the
average burden for preparing and submitting each request is 24 hours.
In addition, we estimate receiving 1 request annually for appeal of
user fee waiver determination, and assume the time needed to prepare an
appeal is 12 hours. We have included in this estimate both the time
needed to prepare the request for appeal to the Chief Scientist and
User Fee Appeals Officer within the Office of the Commissioner, and the
time needed to create and send a copy of the request for an appeal to
the Director Division of User Fee Management within the Office of
Management at FDA's Center for Drug Evaluation and Research.
    We assume 87 hours of burden for completing and submitting Form FDA
3397 (Prescription Drug User Fee Coversheet) for submission of a new
drug application or biologics license application.
    The information collection reflects an overall increase since our
last request for OMB review and approval. We attribute this to expected
fluctuations in submissions to the Agency.

    Dated: February 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-02617 Filed 2-7-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 7 (Wednesday, January 11, 2012)]
[Notices]
[Pages 1677-1679]
[FR Doc No: 2012-336]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2011-1017; FRL-9331-6]

FIFRA Scientific Advisory Panel; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: There will be a 2-day meeting of the Federal Insecticide,
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to
consider and review Methods for Efficacy Testing of Bed Bug Pesticide
Products.

DATES: The meeting will be held on March 6-7, 2012, from approximately
8:30 a.m. to 5 p.m.
    Comments. The Agency encourages that written comments be submitted
by February 21, 2012, and requests for oral comments be submitted by
February 28, 2012. However, written comments and requests to make oral
comments may be submitted until the date of the meeting, but anyone
submitting written comments after February 21, 2012, should contact the
Designated Federal Official (DFO) listed under FOR FURTHER INFORMATION
CONTACT. For additional instructions, see Unit I.C. of the
SUPPLEMENTARY INFORMATION.
    Nominations. Nominations of candidates to serve as ad hoc members
of FIFRA SAP for this meeting should be provided on or before January
25, 2012.
    Webcast. This meeting may be Webcast. Please refer to the FIFRA
SAP's Web site, http://www.epa.gov/scipoly/SAP for information on how
to access the Webcast. Please note that the Webcast is a supplementary
public process provided only for convenience. If difficulties arise
resulting in Webcasting outages, the meeting will continue as planned.
    Special accommodations. For information on access or services for
individuals with disabilities, and to request accommodation of a
disability, please contact the DFO listed under FOR FURTHER INFORMATION
CONTACT at least 10 days prior to the meeting to give EPA as much time
as possible to process your request.

ADDRESSES: The meeting will be held at the Environmental Protection
Agency, Conference Center, Lobby Level, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA 22202.
    Comments. Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2011-1017, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2011-1017. If your comments contain any information that you consider
to be CBI or otherwise protected, please contact the DFO listed under
FOR FURTHER INFORMATION CONTACT to obtain special instructions before
submitting your comments. EPA's policy is that all comments received
will be included in the docket without change and may be made available
on-line at http://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through
regulations.gov or email. The regulations.gov Web site is an
``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an email comment directly to EPA without
going through regulations.gov, your email address will be automatically
captured and included as part of the comment that is placed in the
docket and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.
    Nominations, requests to present oral comments, and requests for
special accommodations. Submit nominations to serve as ad hoc members
of FIFRA SAP, requests for special seating accommodations, or requests
to present oral comments to the DFO listed under FOR FURTHER
INFORMATION CONTACT.

FOR FURTHER INFORMATION CONTACT: Joseph Bailey, DFO, Office of Science
Coordination and Policy (7201M), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:

(202) 564-2045; fax number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. This action may,
however, be of interest to persons who are or may be required to
conduct testing of chemical substances under the Federal Food, Drug,
and Cosmetic Act (FFDCA), FIFRA, and the Food Quality Protection Act of
1996 (FQPA). Since other entities may also be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the DFO
listed under FOR FURTHER INFORMATION CONTACT.

B. What should I consider as I prepare my comments for EPA?

    When submitting comments, remember to:
    1. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    2. Follow directions. The Agency may ask you to respond to specific
questions or organize comments by referencing a Code of Federal
Regulations (CFR) part or section number.
    3. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    4. Describe any assumptions and provide any technical information
and/or data that you used.
    5. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    6. Provide specific examples to illustrate your concerns and
suggest alternatives.
    7. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    8. Make sure to submit your comments by the comment period deadline
identified.

C. How may I participate in this meeting?

    You may participate in this meeting by following the instructions
in this unit. To ensure proper receipt by EPA, it is imperative that
you identify docket ID number EPA-HQ-OPP-2011-1017 in the subject line
on the first page of your request.
    1. Written comments. The Agency encourages that written comments be
submitted, using the instructions in ADDRESSES, no later than February
21, 2012, to provide FIFRA SAP the time necessary to consider and
review the written comments. Written comments are accepted until the
date of the meeting, but anyone submitting written comments after
February 21, 2012, should contact the DFO listed under FOR FURTHER
INFORMATION CONTACT. Anyone submitting written comments at the meeting
should bring 30 copies for distribution to FIFRA SAP. Written comments
received after the close of the meeting may not be considered by the
Panel.
    2. Oral comments. The Agency encourages that each individual or
group wishing to make brief oral comments to FIFRA SAP submit their
request to the DFO listed under FOR FURTHER INFORMATION CONTACT no
later than February 28, 2012, in order to be included on the meeting
agenda. Requests to present oral comments will be accepted until the
date of the meeting and, to the extent that time permits, the Chair of
the FIFRA SAP may permit the presentation of oral comments at the
meeting by interested persons who have not previously requested time.
The request should identify the name of the individual making the
presentation, the organization (if any) the individual will represent,
and any requirements for audiovisual equipment (e.g., overhead
projector, 35 mm projector, chalkboard). Oral comments before the FIFRA
SAP are limited to approximately 5 minutes unless prior arrangements
have been made. In addition, each speaker should bring 30 copies of his
or her comments and presentation slides for distribution to the FIFRA
SAP at the meeting.
    3. Seating at the meeting. Seating at the meeting will be open and
on a first-come basis.
    4. Request for nominations to serve as ad hoc members of the FIFRA
SAP for this meeting. As part of a broader process for developing a
pool of candidates for each meeting, the FIFRA SAP staff routinely
solicits the stakeholder community for nominations of prospective
candidates for service as ad hoc members of the FIFRA SAP. Any
interested person or organization may nominate qualified individuals to
be considered as prospective candidates for a specific meeting.
Individuals nominated for this meeting should have expertise in one or
more of the following areas: Insecticide testing/bioassay design and
evaluation, bed bug biology and statistical analysis and evaluation.
Nominees should be scientists who have sufficient professional
qualifications, including training and experience, to be capable of
providing expert comments on the scientific issues for this meeting.
Nominees should be identified by name, occupation, position, address,
and telephone number. Nominations should be provided to the DFO listed
under FOR FURTHER INFORMATION CONTACT on or before January 25, 2012.
The Agency will consider all nominations of prospective candidates for
this meeting that are received on or before this date. However, final
selection of ad hoc members for this meeting is a discretionary
function of the Agency.
    The selection of scientists to serve on the FIFRA SAP is based on
the function of the panel and the expertise needed to address the
Agency's charge to the panel. No interested scientists shall be
ineligible to serve by reason of their membership on any other advisory
committee to a Federal department or agency or their employment by a
Federal department or agency except the EPA. Other factors considered
during the selection process include availability of the potential
panel member to fully participate in the panel's reviews, absence of
any conflicts of interest or appearance of lack of impartiality,
independence with respect to the matters under review, and lack of
bias. Although financial conflicts of interest, the appearance of lack
of impartiality, lack of independence, and bias may result in
disqualification, the absence of such concerns does not assure that a
candidate will be selected to serve on the FIFRA SAP. Numerous
qualified candidates are identified for each panel. Therefore,
selection decisions involve carefully weighing a number of factors
including the candidates' areas of expertise and professional
qualifications and achieving an overall balance of different scientific
perspectives on the panel. In order to have the collective breadth of
experience needed to address the Agency's charge for this meeting, the
Agency anticipates selecting approximately 10 ad hoc scientists.
    FIFRA SAP members are subject to the provisions of 5 CFR part 2634,
Executive Branch Financial Disclosure, as supplemented by the EPA in 5
CFR part 6401. In anticipation of this requirement, prospective
candidates for service on the FIFRA SAP will be asked to submit
confidential financial information which shall fully disclose, among
other financial interests, the candidate's employment, stocks and
bonds, and where applicable, sources of research support. The EPA will
evaluate the candidates financial disclosure form to assess whether
there are financial conflicts of interest, appearance of a lack of
impartiality or any prior

involvement with the development of the documents under consideration
(including previous scientific peer review) before the candidate is
considered further for service on the FIFRA SAP. Those who are selected
from the pool of prospective candidates will be asked to attend the
public meetings and to participate in the discussion of key issues and
assumptions at these meetings. In addition, they will be asked to
review and to help finalize the meeting minutes. The list of FIFRA SAP
members participating at this meeting will be posted on the FIFRA SAP
Web site at http://www.epa.gov/scipoly/sap or may be obtained from the
OPP Regulatory Public Docket at http://www.regulations.gov.

II. Background

A. Purpose of FIFRA SAP

    The FIFRA SAP serves as the primary scientific peer review
mechanism of EPA's Office of Chemical Safety and Pollution Prevention
(OCSPP) and is structured to provide scientific advice, information and
recommendations to the EPA Administrator on pesticides and pesticide-
related issues as to the impact of regulatory actions on health and the
environment. The FIFRA SAP is a Federal advisory committee established
in 1975 under FIFRA that operates in accordance with requirements of
the Federal Advisory Committee Act. The FIFRA SAP is composed of a
permanent panel consisting of seven members who are appointed by the
EPA Administrator from nominees provided by the National Institutes of
Health and the National Science Foundation. FIFRA, as amended by FQPA,
established a Science Review Board consisting of at least 60 scientists
who are available to the SAP on an ad hoc basis to assist in reviews
conducted by the SAP. As a peer review mechanism, the FIFRA SAP
provides comments, evaluations and recommendations to improve the
effectiveness and quality of analyses made by Agency scientists.
Members of the FIFRA SAP are scientists who have sufficient
professional qualifications, including training and experience, to
provide expert advice and recommendation to the Agency.

B. Public Meeting

    The bed bug is an obligate blood-feeding pest that has been a
persistent pest to people throughout recorded history. Bed bugs have
lived in close proximity to humans in the United States but their
populations dropped dramatically during the mid-20th century. The
United States is one of many countries now experiencing a resurgence of
the population of bed bugs. Though the exact cause is not known,
experts suspect the resurgence is associated with increased resistance
of bed bugs to available pesticides, greater international and domestic
travel, lack of knowledge regarding control of bed bugs due to their
prolonged absence, and the continuing decline or elimination of
effective vector/pest control programs at state and local public health
agencies. In recent years, public health agencies across the country
have been overwhelmed by complaints about bed bugs. An integrated
approach to bed bug control involving Federal, state, tribal and local
public health professionals, together with pest management
professionals, housing authorities and private citizens, will promote
development and understanding of the best methods for managing and
controlling bed bugs and preventing future infestations. Research,
training and public education are critical to an effective strategy for
reducing public health issues associated with the resurgence of bed bug
populations.
    EPA-registered pesticide products are an important part of pest
management programs to accomplish bed bug control. In the past 5 years,
some product users have reported failures due to the lack of bed bug
susceptibility to pesticide products. Subsequently, resistance to
pyrethroid insecticides was documented although it has not been
directly linked to field application failures. Taken together, these
conditions have raised questions about the validity and value of
efficacy data submitted to EPA that are used to fulfill registration
requirements for bed bug pesticide products. In response, EPA has
evaluated the database for registered products and concluded that there
is a need to standardize approaches to bed bug product testing methods
in order to insure the efficacy of registered products. In order to
accomplish this, the Agency is developing a product performance
guideline for bed bug pesticide products. The Agency will be seeking
advice and recommendations from the SAP on scientific issues associated
with the proposed EPA Guideline ``Methods for Efficacy Testing of Bed
Bug Pesticide Products.''

C. FIFRA SAP Documents and Meeting Minutes

    EPA's background paper, related supporting materials, charge/
questions to the FIFRA SAP, FIFRA SAP composition (i.e., members and ad
hoc members for this meeting), and the meeting agenda will be available
by early February 2012. In addition, the Agency may provide additional
background documents as the materials become available. You may obtain
electronic copies of these documents, and certain other related
documents that might be available electronically, at http://www.regulations.gov and the FIFRA SAP homepage at http://www.epa.gov/
scipoly/sap.
    The FIFRA SAP will prepare meeting minutes summarizing its
recommendations to the Agency approximately 90 days after the meeting.
The meeting minutes will be posted on the FIFRA SAP Web site or may be
obtained from the OPP Regulatory Public Docket at http://www.regulations.gov.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: December 28, 2011.
Stephen M. Knott,
Acting Director, Office of Science Coordination and Policy.
[FR Doc. 2012-336 Filed 1-10-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 56 (Friday, March 24, 2017)]
[Notices]
[Pages 15081-15085]
[FR Doc No: 2017-05853]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-80280; File No. SR-DTC-2017-001]

Self-Regulatory Organizations; The Depository Trust Company;
Notice of Filing of Proposed Rule Change To Establish a Sub-Account for
Use With the DTCC Euroclear Global Collateral Ltd Collateral Management
Service and Provide for the Authorization of a Representative To
Receive Information About the Sub-Account

March 20, 2017.
    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 March 9, 2017, The Depository Trust Company (``DTC'') filed with the
Securities and Exchange Commission (``Commission'') the proposed rule
change as described in Items I, II and III below, which Items have been
prepared by DTC. 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.
---------------------------------------------------------------------------

I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    The proposed rule change consists of amendments to Rules, By-Laws
and Organization Certificate of The Depository Trust Company (the ``DTC
Rules'') \3\ in order to add new Rule 35 (CMS Reporting) which would
provide that any DTC Participant that is, or is acting on behalf of, a
user of certain collateral management services (``CMS'') \4\ of DTCC
Euroclear Global Collateral Ltd. (``DEGCL'') \5\ may establish one or
more sub-Accounts for use in connection with CMS (each, a ``CMS Sub-
Account''). A DTC Participant that establishes a CMS Sub-Account
pursuant to the proposed rule (a ``CMS Participant'') would thereby:
(i) Authorize DEGCL to receive account and transactional information
and reports with respect to the CMS Sub-Account, and (ii) direct DTC to
provide such information and reports to DEGCL, as described in detail
below.
---------------------------------------------------------------------------

    \3\ Each capitalized term not otherwise defined herein has its
respective meaning as set forth in the Rules, By-Laws and
Organization Certificate of The Depository Trust Company (the ``DTC
Rules''), available at http://www.dtcc.com/legal/rules-and-procedures.aspx.
    \4\ In particular, there will be a CMS option authorizing DEGCL,
on behalf of the CMS User, to propose collateral allocations to
satisfy counterparty obligations of the CMS User, referred to by
DEGCL as the ``Allocation Option'' and further explained below.
    \5\ DEGCL is a joint venture of The Depository Trust & Clearing
Corporation (``DTCC''), the corporate parent of DTC, and Euroclear
S.A./N.V. (``Euroclear''), the corporate parent of Euroclear Bank,
described further below. DTC understands that CMS will be operated
by Euroclear Bank and other entities in the Euroclear group, as
service providers to DEGCL, in accordance with appropriate
agreements between them.
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II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

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

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

1. Purpose
    The proposal would add new Rule 35 (CMS Reporting), which would
provide that any DTC Participant that is, or is acting on behalf of, a
user of DEGCL CMS may establish one or more CMS Sub-Accounts. A CMS
Participant would thereby: (i) Authorize DEGCL to receive account and
transactional information and reports with respect to the CMS Sub-
Account, and (ii) direct DTC to provide such information and reports to
DEGCL, as described below.
(i) Background
(a) DEGCL
    DEGCL was formed in the United Kingdom (``UK''), and is authorized
by the Financial Conduct Authority (``FCA'') \6\ in the UK as a
``service company'' in accordance with applicable law of the UK.\7\
DEGCL was formed for the purpose of offering global information, record
keeping, and processing services for derivatives collateral
transactions and other types of financing transactions. DEGCL seeks to
provide services to buy-side and sell-side financial institutions that
seek increased efficiency in the availability and deployment of
collateral and streamlined margin processing, in light

of new and enhanced regulatory requirements.\8\ These requirements have
resulted in increased capital requirements, mandatory central clearing
of more derivative transactions, and new margining rules for bilateral
trades, driving a significant increased demand for high quality
collateral, and for efficient and effective deployment of collateral.
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    \6\ The FCA is an independent public body that regulates 56,000
financial services firms and financial markets in the UK financial
services firms in the UK. It is accountable to the UK Treasury,
which is responsible for the UK's financial system, and to
Parliament.
    \7\ DEGCL was authorized as a ``service company'' by the FCA on
March 29, 2016. A ``service company,'' as defined in the FCA
Handbook, Glossary, is: ``[A] firm whose only permitted activities
are making arrangements with a view to transactions in investments,
and agreeing to carry on that regulated activity, and whose Part 4A
permission: (a) Incorporates a limitation substantially to the
effect that the firm carry on regulated activities only with market
counterparties or intermediate customers; and (b) includes
requirements substantially to the effect that the firm must not: (i)
Guarantee, or otherwise accept responsibility for, the performance,
by a participant in arrangements made by the firm in carrying on
regulated activities, of obligations undertaken by that participant
in connection with those arrangements; or (ii) approve any financial
promotion on behalf of any other person or any specified class of
persons; or (iii) in carrying on its regulated activities, provide
services otherwise than in accordance with documents (of a kind
specified in the requirement) provided by the firm to the FCA.'' FCA
Handbook, Glossary, available at https://www.handbook.fca.org.uk/handbook/glossary.
    \8\ See Basel III liquidity rules (Basel Committee on Banking
Supervision, Basel III: A global framework for more resilient banks
and the banking system, December 2010 and revised June 2011; Basel
Committee on Banking Supervision, Basel III: The Liquidity Coverage
Ratio and liquidity risk monitoring tools, January 2013; Basel
Committee on Banking Supervision, Basel III: The net stable funding
ratio, October 2014, available at www.bis.org/bcbs/basel3.htm), as
well as recent regulatory changes by the Commodity Futures Trading
Commission (Margin Requirements for Uncleared Swaps for Swap Dealers
and Major Swap Participants, 81 FR 635 (January 6, 2016); 17 CFR 23
and 140), the U.S. prudential regulators (Margin and Capital
Requirements for Covered Swap Entities, 80 FR 74840 (November 30,
2015); 12 CFR parts 45, 237, 349, 624 and 1221. The U.S. prudential
regulators include: Office of the Comptroller of the Currency--
Treasury, Board of Governors of the Federal Reserve System, Federal
Deposit Insurance Corporation, Farm Credit Administration, and the
Federal Housing Finance Agency), European Market Infrastructure
Regulation (European Supervisory Authorities' (ESAs) Final Draft
Regulatory Technical Standards on risk-mitigation techniques for
OTC-derivative contracts not cleared by a CCP under Article 11(15)
of Regulation (EU) No 648/2012 (EMIR), available at https://www.eba.europa.eu/documents/10180/1398349/RTS+on+Risk+Mitigation+Techniques+for+OTC+contracts+%28JC-2016-+18%29.pdf/fb0b3387-3366-4c56-9e25-74b2a4997e1d), and the Basel
Committee on Banking Supervision (``BCBS'') and the International
Organization of Securities Commissions (``IOSCO'') (BCBS-IOSCO,
Margin requirements for non-centrally cleared derivatives (March
2015), available at http://www.bis.org/bcbs/publ/d317.htm).
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(b) DEGCL CMS Options
    DEGCL performs information and record-keeping services for CMS
users who have entered into user agreements with DEGCL for this purpose
(``CMS Users''). CMS Users are financial institutions that are
counterparties to agreements establishing obligations between them to
provide securities collateral with respect to swaps or other types of
financing transactions. These bilateral swap or other financing
agreements are entered into by such counterparties outside, and
independently, of DEGCL or DTC.\9\
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    \9\ A CMS User will typically be a major financial institution
or buy-side investor that is a bank, broker dealer, or investment
company. CMS Users will enter into a Collateral Management Service
Agreement with DEGCL, which includes general terms of conditions and
operating procedures (``CMS Agreement'').
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    DEGCL will provide two CMS service options for the selection of
collateral to satisfy these external collateral obligations. For use of
these options at DEGCL, both counterparties must agree with DEGCL to
apply the same collateral selection option to a transaction between
them.
    The first option is referred to by DEGCL as the ``Standard Option''
(also referred to as ``self-select''). The Standard Option relates to
securities collateral at any U.S. settlement location and does not
depend on the proposed rule change. It is described in this rule filing
for informational purposes only.
    The second collateral selection option is referred to by DEGCL as
the ``Allocation Option'' (also referred to as ``auto-select''). This
option relates to securities collateral held at DTC; the offering of
this option by DEGCL depends on, and is subject to, approval of the
proposed rule change. The CMS User with the obligation to deliver
collateral must be a CMS Participant under the proposed rule change, or
the customer of a CMS Participant acting on its behalf.\10\ The CMS
User that is the counterparty receiving collateral must also be either
a DTC Participant or the customer of a DTC Participant acting on its
behalf.\11\
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    \10\ As further described below, a CMS Sub-Account is an account
from which securities collateral may be delivered by a CMS
Participant pursuant to the Allocation Option.
    \11\ The receiving DTC Participant is not a ``CMS Participant''
as defined in proposed Rule 35.
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(c) Standard Option, for Securities Collateral Held at Various
Settlement Locations
    CMS Users may elect the Standard Option for securities held at any
applicable settlement location, including custodial banks and DTC.
Under the Standard Option, a CMS User will have the option to specify
to DEGCL, obligation by obligation, what collateral to transfer with
respect to each counterparty collateral obligation and at what
settlement location, hence ``self-select.'' DEGCL will process the
information it receives from the CMS User and generate proposed
settlement instructions for the transfer of such collateral at the
applicable settlement location. DEGCL will send its proposed settlement
instructions to the CMS User and/or its agent, referred to by DEGCL as
a designated settlement service provider (``DSSP'').\12\ The DSSP will
determine whether to issue the proposed settlement instructions to the
applicable settlement location.
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    \12\ DSSP is a DEGCL concept, not a DTC defined term. DTC
understands that, pursuant to the CMS Agreement, a CMS User must
either appoint a DSSP or act as its own DSSP, and the DSSP, as agent
of the CMS User, is responsible for receiving the proposed
settlement instructions (and other information) from DEGCL, and
acting on such information in the manner agreed by the CMS User and
its DSSP. If the applicable settlement location is DTC, the DSSP
must be a DTC Participant that may instruct DTC in accordance with
DTC Rules and Procedures. Because the Standard Option does not
depend on a CMS Sub-Account, such DTC Participant is not a CMS
Participant for purposes of the proposed rule change.
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    For the Standard Option applied to securities collateral for which
DTC is the applicable settlement location, DEGCL will not receive any
information from DTC and, therefore, this option is not subject to the
proposed rule change. The CMS User will self-report information to
DEGCL.
(c) Allocation Option for Securities Collateral Held at DTC
    The Allocation Option would only be used in connection with
Eligible Securities held at DTC in a CMS Sub-Account by a CMS
Participant (``CMS Securities''). The CMS Participant may be a CMS User
acting for itself or a DTC Participant acting on behalf of a CMS User
as the CMS Participant.\13\ As described below, the Allocation Option
is dependent on DEGCL receiving certain information from DTC for the
applicable CMS Sub-Account of the applicable CMS Participant. The
proposed rule change provides a mechanism for a CMS Participant to
authorize DEGCL as its ``CMS Representative'' to receive the necessary
information from DTC, and to direct DTC to provide DEGCL with that
information, as described in detail below.
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    \13\ DTC understands that, for purposes of the Allocation
Option, DEGCL would consider the CMS Participant to be the DSSP.
---------------------------------------------------------------------------

(ii) Proposed Rule Change
(a) The Proposed Rule Change Would Establish Dedicated CMS Sub-Accounts
at DTC for CMS Participants and Provide That a CMS Participant
Authorizes DEGCL, as its CMS Representative, To Receive Certain
Information About its CMS Sub-Accounts and Directs DTC To Provide the
Information to DEGCL, as its CMS Representative
    The proposed rule change would allow a CMS Participant to establish
one or more CMS Sub-Accounts. A CMS Participant would, from time to
time, instruct DTC to transfer Securities from its Account to its CMS
Sub-Account, to be available for allocation by DEGCL to delivery or
pledge by book-entry at DTC in accordance with DTC Rules and Procedures
(including risk management controls),\14\ in satisfaction of the
various

collateral obligations of the CMS Participant or the CMS User on behalf
of which the CMS Participant is acting.
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    \14\ DTC risk management controls, including Collateral Monitor
and Net Debit Cap (as defined in Rule 1, Section 1 of the DTC
Rules), are designed so that DTC may complete system-wide settlement
notwithstanding the failure to settle of its largest Participant or
Affiliated Family of Participants. The Collateral Monitor tests
whether a Participant has sufficient collateral for DTC to pledge or
liquidate if that Participant were to fail to meet its settlement
obligation. Pursuant to these controls under applicable DTC Rules
and Procedures, any Delivery instruction order to a CMS Sub-Account
that would cause the CMS Participant to exceed its Net Debit Cap or
to have insufficient DTC Collateral to secure its obligations to
DTC, would not be processed by DTC. Deliveries would be processed in
the same order and with the same priority as otherwise provided in
the DTC Rules and Procedures, i.e., such Deliveries would not take
precedence over any other type of Delivery in the DTC system.
---------------------------------------------------------------------------

    By establishing a CMS Sub-Account, a CMS Participant would be: (a)
Authorizing DEGCL, as its CMS Representative, to receive the
information defined below regarding CMS Securities credited to the CMS
Sub-Account at the time of the report (``CMS Report''), and regarding
any Delivery or Pledge from, or Delivery or Release to, the CMS Sub-
Account (``CMS Delivery Information''); \15\ (b) representing and
warranting that it is duly authorized to instruct DTC to provide the
CMS Reports and CMS Delivery Information about such CMS Sub-Account to
the CMS Representative; (c) directing DTC to provide the CMS Reports
and CMS Delivery Information to DEGCL; \16\ and (d) representing and
warranting that it would conduct business in such CMS Sub-Account as
provided in proposed Rule 35, and otherwise pursuant to the DTC Rules
and Procedures, and in compliance with applicable law.
---------------------------------------------------------------------------

    \15\ Each CMS Participant would continue to be liable as
principal for the actions of its CMS Representative and would
indemnify DTC against any claim or loss arising from any act or
omission of its CMS Representative, or arising from DTC's provision
of the CMS Report and CMS Delivery Information to DEGCL or the
receipt and use thereof by DEGCL, except to the extent caused
directly by DTC's gross negligence or willful misconduct.
    \16\ The CMS Report and CMS Delivery Information would be
transmitted to DEGCL using DTCC's existing Common Data Transfer
Service (``CDTS'') over a dedicated BT Radianz link. CDTS is DTCC's
proprietary file input and output management system. It enables DTCC
to securely and reliably automate the exchange of files over a
network link with its Participants, Members, and third-parties. See
CDTS User Guide and Schemas, available at http://www.dtcc.com/~/
media/Files/Downloads/Settlement-Asset-Services/Underwriting/
CDTS.zip. BT Radianz is an existing DTCC network service provider.
---------------------------------------------------------------------------

    The CMS Report would include, with respect to the CMS Securities
credited to a CMS Sub-Account of such CMS Participant at the time of
such report, the following information: (a) The CUSIP, ISIN, or other
identification number of the CMS Securities and (b) the number of
shares or other units or principal amount of the CMS Securities. CMS
Delivery Information would be provided in real time, and would include,
with respect to (i) each Delivery or Pledge of CMS Securities from, or
(ii) Delivery or Release of CMS Securities to a CMS Sub-Account, a copy
of any Delivery, Pledge, or Release message with respect to the CMS
Sub-Account, including the following information: (x) The CUSIP, ISIN,
or other identification number of such CMS Securities and (y) the
number of shares or other units or principal amount of such CMS
Securities.
(b) The Proposed Rule Change Supports a CMS Participant's Use of the
DEGCL CMS Allocation Option
    As explained above, once the CMS Participant establishes a CMS Sub-
Account, DTC would send CMS Reports and CMS Delivery Information for
that CMS Sub-Account to DEGCL. The CMS Reports and CMS Delivery
Information would provide DEGCL with up-to-date snapshots of the
Securities credited to the CMS Sub-Account to identify to DEGCL the
available CMS Securities from which it could propose allocations for
Delivery or Pledge by book-entry at DTC in accordance with DTC Rules
and Procedures (including risk management controls) and for DEGCL to
maintain such information and records as it has agreed with CMS Users
that it will maintain.
    DEGCL would review the Securities credited to a CMS Sub-Account and
verify, through a series of algorithms, which CMS Securities in the CMS
Sub-Account meet the collateral obligations of the applicable CMS User
to its several counterparties that are CMS Users that have agreed to
the Allocation Option. Based on the results, DEGCL would formulate a
set of proposed settlement instructions for the Deliveries and/or
Pledges of the CMS Securities in accordance with the DTC Rules and
Procedures, including risk management controls.\17\ DEGCL would then
transmit the proposed settlement instructions to the CMS Participant,
acting on its own behalf or on behalf of a CMS User; the CMS
Participant would determine whether to submit the proposed settlement
instruction(s) to DTC. That is, the CMS Participant remains responsible
for deciding whether to submit the proposed settlement instructions.
Once the CMS Participant submits the settlement instruction to DTC,
DEGCL would receive the corresponding Delivery Information and update
its records accordingly.
---------------------------------------------------------------------------

    \17\ See supra note 12.
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(c) Proposed Rule
    The proposed rule change would add Rule 35 to the DTC Rules, to
provide for:
    i. The defined terms applicable to the proposed Rule 35,\18\
---------------------------------------------------------------------------

    \18\ The defined terms would be CMS, CMS Delivery Information,
CMS Participant, CMS Report, CMS Representative, CMS Securities, CMS
Sub-Account, DEGCL, and DTCC, as discussed above.
---------------------------------------------------------------------------

    ii. the establishment and maintenance of one or more CMS Sub-
Accounts for each CMS Participant;
    iii. each CMS Participant's authorization of DEGCL as its CMS
Representative;
    iv. each CMS Participant's representation and warranty that it is
duly authorized to instruct DTC to provide the CMS Reports and CMS
Delivery Information about such CMS Sub-Account to the CMS
Representative, and that it would conduct business in such CMS Sub-
Account as provided in proposed Rule 35 and otherwise pursuant to the
DTC Rules and Procedures, and in compliance with applicable law;
    v. information to be provided by DTC to the CMS Representative of
the CMS Participant, specifically, the CMS Report and CMS Delivery
Information;
    vi. Deliveries of Securities by a CMS Participant from an Account
of the CMS Participant to its CMS Sub-Account, and Deliveries and
Pledges from its CMS Sub-Account;
    vii. each CMS Participant's liability as principal for the actions
of its CMS Representative with respect to all matters provided under
proposed Rule 35 or otherwise;
    viii. DTC's disclaimer of liability to: (x) Any CMS Participant as
a result of providing the CMS Report and CMS Delivery Information to
its CMS Representative pursuant to proposed Rule 35; (y) the CMS
Representative or any CMS Participant as a result of (i) any loss
relating to proposed Rule 35, unless caused directly by DTC's gross
negligence, willful misconduct, or violation of federal securities laws
for which there is a private right of action or (ii) any force majeure,
market disruption, or technical malfunction, or (z) any third party for
any reason; and
    ix. indemnification of DTC by the CMS Participant for any loss
arising from any act or omission of its CMS Representative, or arising
from the provision of the CMS Report and CMS Delivery Information to
its CMS Representative or the receipt and use thereof by the CMS
Representative, except to the extent caused directly by DTC's gross
negligence or willful misconduct.

Implementation Timeframe
    DTC will implement the proposed rule change upon approval of this
filing by the Commission.
2. Statutory Basis
    DTC believes that the proposed rule change is consistent with the
requirements of the Act, and the rules and regulations thereunder
applicable to DTC, in particular Section 17A(b)(3)(F) of the Act,\19\
and Rule 17Ad-22(d)(7) promulgated thereunder.\20\
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78q-1(b)(3)(F).
    \20\ 17 CFR 240.17Ad-22(d)(7).
---------------------------------------------------------------------------

    Section 17A(b)(3)(F) of the Act \21\ requires, inter alia, that the
DTC Rules be designed to promote the prompt and accurate clearance and
settlement of securities transactions. By looking across transactions
of a CMS User with multiple counterparties, the Allocation Option would
offer efficiency by automating the selection of appropriate securities
collateral to satisfy applicable collateral obligations. Proposed Rule
35 would provide a mechanism for DTC to provide information on behalf
of CMS Participants to DEGCL, so that they may avail themselves of the
efficiency of the Allocation Option and would not need to transmit
delivery and position information to DEGCL. By supporting this
efficiency in the collateral sector, DTC is helping to streamline the
settlement of the increasing volume of collateral transactions, thereby
promoting the prompt and accurate clearance and settlement, consistent
with the requirements of the Act, in particular Section 17A(b)(3)(F),
cited above.
---------------------------------------------------------------------------

    \21\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    Rule 17Ad-22(d)(7) promulgated under the Act \22\ requires that a
registered clearing agency establish, implement, maintain and enforce
written policies and procedures reasonably designed to evaluate the
potential sources of risks that can arise when the clearing agency
establishes links either cross-border or domestically to clear or
settle trades, and ensure that the risks are managed prudently on an
ongoing basis. In developing this proposal, DTC evaluated the market,
liquidity, operational, and information security, technology, and
privacy risks that could arise in allowing CMS Participants to
establish a CMS Sub-Account and allow DTC to provide information to
DEGCL in support of the Allocation Option. Such risks include data
error from the communication link or the external communication of a
CMS Participant's proprietary information. DTC determined that the
identified risks are mitigated because (i) the Allocation Option would
not require any material change to DTC's settlement framework,
technology or operating procedures including existing settlement cycles
and risk management controls; (ii) DTCC's Technology Risk Management
existing control procedures will manage data integrity and
authorization provisioning to mitigate information and technology risk;
and (iii) DEGCL is only receiving CMS Reports and CMS Delivery
Information from a CMS Sub-Account specifically designated for this
purpose by a CMS Participant. As a result, the CMS Sub-Account activity
and reporting should be well monitored. Accordingly, DTC believes the
proposed Rule 35 is consistent with DTC's obligations under Rule 17Ad-
22(d)(7), cited above.
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    \22\ 17 CFR 240.17Ad-22(d)(7).
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(B) Clearing Agency's Statement on Burden on Competition

    DTC believes that the proposed rule change would not impose any
burden on competition with respect to fees charged by DTC for the CMS
Sub-Account and associated reporting because there would be no new or
increased fees imposed. For transactions into and out of the CMS Sub-
Account, standard, existing transaction fees would apply. In addition,
DTC believes that the proposed rule change would not impose any burden
on competition with respect to access to the proposed service. The
proposed service is optional and would be available to all DTC
Participants that choose to be CMS Users of the Allocation Option (or
DTC Participants' customers that choose to be CMS Users of the
Allocation Option and agree that such DTC Participants will act on
their behalf in respect of this activity). However, DTC recognizes that
the proposed rule is tailored to support a specialized service
available only to such CMS Users. DTC relies on the representations of
DEGCL that it provides open access to diverse CMS Users and thus,
indirectly, the benefits of the proposed rule change should be
available on a broad basis to industry members requiring such services,
not imposing a burden on competition in this respect.

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

    Written comments relating to the proposed rule change have not been
solicited or received. DTC will notify the Commission of any written
comments received by DTC.

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

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-DTC-2017-001 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-2017-001. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet 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 Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for

inspection and copying at the principal office of DTC and on DTCC's Web
site (http://dtcc.com/legal/sec-rule-filings.aspx). All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-DTC-2017-001 and should be
submitted on or before April 14, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\23\
---------------------------------------------------------------------------

    \23\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-05853 Filed 3-23-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 109 (Thursday, June 6, 2013)]
[Rules and Regulations]
[Pages 33971-33972]
[FR Doc No: 2013-13424]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2012-0911]

Drawbridge Operation Regulation; City Waterway Also Known as Thea
Foss Waterway, Tacoma, WA

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the South 11th Street (``Murray
Morgan'') Bridge across the City Waterway also known as the

Thea Foss Waterway, mile 0.6, at Tacoma, WA. The current test deviation
will expire 8 a.m. June 15, 2013. This deviation is necessary to
continue with the current operating schedule until the final rulemaking
changes permanently go into effect.

DATES: This deviation is effective from 8 a.m. on June 15, 2013 to 8
a.m. June 30, 2013.

ADDRESSES: The docket for this deviation, [USCG-2012-0911] is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this deviation. You may also visit the Docket
Management Facility in Room W12-140 on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Lieutenant Commander Steven Fischer,
Bridge Specialist, Coast Guard Thirteenth District; telephone 206-220-
7277, email<EMAIL_ADDRESS>If you have questions on
viewing the docket, call Barbara Hairston, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: On November 20, 2012, the Coast Guard
published a notice of proposed rulemaking (NPRM) entitled, ``Drawbridge
Operation Regulation; Thea Foss Waterway previously known as City
Waterway, Tacoma, WA'' in the Federal Register (77 FR 69576). This NPRM
proposed three changes to the operating schedule of the Murray Morgan
Bridge, also known as the South 11th Street Bridge, across Thea Foss
Waterway, previously known as City Waterway, mile 0.6, at Tacoma.
    The first change requires that for bridge openings needed between
10 p.m. and 8 a.m., notification be made no later than 8 p.m. prior to
the desired opening. This differs from the existing regulation in that
presently the bridge is required to open at all times (except during
authorized closure periods) provided two hours advance notice is given.
Over an 18 month period there were only 6 bridge openings requested
between 10 p.m. and 8 a.m. which averages one bridge opening request
per three month period. One of the unique features of the Murray Morgan
Bridge is its height above the waterway providing 60 feet of clearance
at mean high water (MHW) in the closed position. Because of this
vertical clearance the overwhelming majority of vessels which transit
this waterway do not require a bridge opening. The majority of bridge
openings are for locally moored and operated recreational sailboats
with mast heights over 60 feet. Almost all of these vessels are moored
at marinas in very close proximity of the bridge.
    The second change is removing the authorized bridge closure periods
in the morning and afternoon. The current regulation states that the
draw need not be opened from 6:30 a.m. to 8:30 a.m. and 3:30 p.m. to
5:30 p.m. Monday through Friday, for vessels of less than 1,000 gross
tons. This change requires the draw to open at all times with proper
advance notification. The morning and afternoon authorized closures of
the bridge outlined in the existing regulation were put into place when
the bridge was part of SR 509, a continuous route from Northeast Tacoma
to downtown, and traffic volumes were approximately 15,000 vehicles per
day. In 1997 a new SR 509 was constructed approximately 0.7 miles south
of the bridge and is now used as the main traffic corridor. After
completion of the new SR 509, the Murray Morgan Bridge connection
between Northeast Tacoma and downtown was severed due to roadway
reconfiguration, resulting in traffic volumes dropping dramatically;
therefore, the bridge no longer conveys high volumes of traffic during
the morning and afternoon rush hours.
    The third change is principally administrative and changes the
contact information for emergency bridge openings. The existing
regulation states ``In emergencies, openings shall be made as soon as
possible upon notification to the Washington State Department of
Transportation.'' The change requires notification for emergency
opening to be made to the City of Tacoma. The reason for this change is
because Washington State turned over ownership and responsibility of
the bridge to the City of Tacoma on January 6, 1998.
    In conjunction with the NPRM published on November 20, 2012, the
Coast Guard published a temporary deviation from regulations entitled,
``Drawbridge Operation Regulation; Thea Foss Waterway previously known
as City Waterway, Tacoma, WA'' in the Federal Register (77 FR 69562) to
test the operating schedule under the proposed regulations. Under this
temporary deviation the bridge operates as follows: The draw of the
Murray Morgan Bridge, also known as the South 11th Street Bridge,
across Thea Foss Waterway, previously known as City Waterway, mile 0.6,
at Tacoma, shall open on signal if at least two hours notice is given.
However, to obtain a bridge opening between 10 p.m. and 8 a.m.
notification must be made to the City of Tacoma by 8 p.m. In
emergencies, openings shall be made as soon as possible upon
notification to the City of Tacoma. The Murray Morgan Bridge is a
vertical lift bridge which provides a vertical clearance of 60 feet
above mean high water (MHW) while in the closed position and 135 feet
of vertical clearance in the open position. Vessels which do not
require a bridge opening may continue to transit beneath the bridge at
any time.
    This test deviation is set to expire at 8 a.m. June 15, 2013.
However, the final rule which will make these changes to the operating
schedule permanent will not be effective by the date in which the test
deviation expires. Therefore, to maintain safe and efficient transit
through the bridge, the Coast Guard has issued a temporary deviation
from regulations to continue the current operating schedule as laid out
above until June 30, 2013. The Coast Guard will also inform the users
of the waterways through our Local and Broadcast Notices to Mariners of
the closure periods for the bridge so that vessels can arrange their
transits to minimize any impact caused by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: May 23, 2013.
Daryl R. Peloquin,
Bridge Administrator, Thirteenth Coast Guard District.
[FR Doc. 2013-13424 Filed 6-5-13; 8:45 am]
BILLING CODE 9110-04-P


 								September 15, 2010

MEMORANDUM

SUBJECT: CASAC Review of Policy Assessment for the Review of the
Secondary National Ambient Air Quality Standards for NOx and SOx:
Second External Review Draft

FROM: Lydia N. Wegman, Director /s/

Health and Environmental Impacts Division (C504-02)

Office of Air Quality Planning and Standards

United States Environmental Protection Agency

TO: Angela Nugent

Designated Federal Officer

Clean Air Scientific Advisory Committee

EPA Science Advisory Board Staff Office

Attached is the draft document, Policy Assessment for the Review of the
Secondary National Ambient Air Quality Standards for NOx and SOx:
Second External Review Draft (September 2010), prepared by the
Environmental Protection Agency’s (EPA) Office of Air Quality Planning
and Standards (OAQPS) staff as part of EPA’s ongoing review of the
secondary (welfare-based) national ambient air quality standards (NAAQS)
for oxides of nitrogen (NOx) and sulfur (SOx). This document will be the
focus of a review by the Clean Air Scientific Advisory Committee (CASAC)
Oxides of Nitrogen (NOx) and Sulfur Oxides (SOx) Secondary Review Panel
(the CASAC NOx SOx Secondary Panel) at a public meeting to be held in
Durham NC on October 6-7, 2010.  I am requesting that you forward these
draft documents to the CASAC NOx SOx Secondary Panel to prepare for the
October meeting.

As part of the review of the current secondary (welfare-based) NAAQS for
NOx and SOx, EPA’s OAQPS staff has prepared a second draft Policy
Assessment.  This draft Policy Assessment evaluates the policy
implications of the key scientific information contained in the document
Integrated Science Assessment for Oxides of Nitrogen and
Sulfur-Ecological Criteria, prepared by EPA’s National Center for
Environmental Assessment (NCEA) and the results from the analyses
contained in the Risk and Exposure Assessment for Review of the
Secondary National Ambient Air Quality Standards for Oxides of Nitrogen
and Oxides of Sulfur.  These documents, along with EPA’s Integrated
Review Plan, can be found at   HYPERLINK
"http://www.epa.gov/ttn/naaqs/standards/no2so2sec/index.html"
http://www.epa.gov/ttn/naaqs/standards/no2so2sec/index.html .

The second draft Policy Assessment reflects consideration of comments
from the Panel, as well as public comments, on the first draft Policy
Assessment, which was reviewed by the Panel on April 1-2 and May 3,
2010. The main comments from the Panel on the first draft Policy
Assessment were provided to us in a June 22, 2010 letter (Russell and
Samet, 2010). These comments, and the changes made in the second draft
Policy Assessment in response to them, are summarized in Attachment 1.
Note that the structure of the Policy Assessment has changed somewhat
from the first draft.  While there are still 9 chapters, Chapters 5 and
6 in the first draft have been combined into Chapter 5 in the current
draft; Chapter 7 in the first draft is now Chapter 6 in the current
draft, Chapter 7 in the current draft is a new chapter on uncertainty,
variability and sensitivity analyses, and Chapter 8 in the current draft
is a new chapter on monitoring issues.

The current draft contains several placeholders indicating missing
tables or discussions.  We expect to provide the Panel with these tables
and discussions in a separate submission two weeks prior to the October
6-7 Panel meeting.  These will include a table in Chapter 9 summarizing
the options for elements of the standards, a table in Chapter 7
summarizing key uncertainties, and a discussion in Chapter 5 of the
implications of a range of choices of the target percent of lakes and
streams to protect for alternative target ANC levels.  This discussion
will also cover the various spatial aggregation choices and resulting
implications on the target percentages.  We recognize that there are
some formatting issues in several chapters, and these will be addressed
in the final PA.

The CASAC and public comments on the draft Policy Assessment will be
taken into consideration in making revisions to the draft document.  A
final Policy Assessment will be released in December of 2010.  Following
completion of the final Policy Assessment, EPA will conduct a rulemaking
with regard to its review of the secondary NOx and SOx NAAQS.
Consistent with the terms of a consent decree, the EPA Administrator
will sign a notice of proposed rulemaking by July 12, 2011 and a final
rulemaking notice by March 20, 2012.  Draft documents are being made
available to the CASAC NOx SOx Secondary Panel in the form of attached
electronic files. The documents are also available from the EPA website
at   HYPERLINK
"http://www.epa.gov/ttn/naaqs/standards/no2so2sec/index.html"
http://www.epa.gov/ttn/naaqs/standards/no2so2sec/index.html .  Printed
copies of these documents will be sent to CASAC NOx SOx Secondary Panel
members via UPS. A set of charge questions related to the draft Policy
Assessment will be submitted separately.

We look forward to discussing the second draft Policy Assessment with
the CASAC NOx SOx Secondary Panel at our upcoming meeting. Should you
have any questions regarding the first draft NOx SOx Secondary NAAQS
Policy Assessment, please contact me<PHONE_NUMBER>; email
<EMAIL_ADDRESS>or Dr. Bryan Hubbell<PHONE_NUMBER>; email
HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>).

Attachments

cc: 	Vanessa Vu, SAB, OA

John Vandenberg, ORD/NCEA-RTP

Mary Ross, ORD/NCEA-RTP

Ron Evans, OAQPS/HEID

Dale Evarts, OAQPS/HEID

Richard Haeuber,  OAP/CAMD

Karen Martin, OAQPS/HEID

Christine Davis, OAQPS/HEID

Tara Greaver, ORD/NCEA-RTP

Bryan Hubbell, OAQPS/HEID

Meredith Lassiter, OAQPS/HEID

Jason Lynch, OAP/CAMD

Norm Possiel, OAQPS/AQAD

Adam Reff, OAQPS/AQAD

Rich Scheffe, OAQPS/AQAD

Travis Smith, OAQPS/HEID

Ginger Tennant, OAQPS/HEID

Randy Waite, OAQPS/HEID

Nealson Watkins, OAQPS/AQAD

Attachment 1

CASAC comments on first draft PM Policy Assessment and responses to
those comments

The CASAC Panel’s comments and recommendations on the first draft of
the NOx and SOx Secondary NAAQS Policy Assessment, as well as changes
made in the second draft in response to those comments, are summarized
below. Overarching comments and recommendations are summarized below,
followed by comments and recommendations on chapters 2 through 9.

Overarching comments and recommendations

The Panel made several overarching comments and recommendations,
including:

The second draft should include in a separate chapter a more
comprehensive sensitivity and uncertainty analyses of the proposed
approach.  This chapter should provide more reasoning to support EPA’s
assessment of the relative values of the uncertainties.  The sensitivity
analyses should include the sensitivity of the AAPI to component terms.
The chapter should provide a more thorough evaluation of the ability of
CMAQ to simulate the ambient concentrations and wet and dry deposition
fluxes of the SOx, NOx and NHx species used in determining the AAPI.

The second draft should include a succinct discussion of other potential
impacts of NOx deposition to N-limited ecosystems, including potential
production increases that may be either beneficial or adverse depending
on the system and management goals.

The second draft should ensure the use of a consistent set of units in
its presentation of data, results and equations.

In response to these comments, we have made extensive edits throughout
the second draft Policy Assessment to ensure consistent units are used,
and have included a table in Chapter 1 which clearly identifies units
and conversions used in the document (Table 1-1, Section 1.1).   We have
added a new chapter (Chapter 7) which provides a more extensive
discussion of uncertainties and variability in the science, data, and
models which inform our considerations of the standards.  This chapter
also provides assessments of the sensitivity of models and the AAPI to
inputs.   We have added additional discussions of the broader set of
potential impacts of NOx deposition, while continuing to focus the
overall review on the effects of NOx and SOx deposition on sensitive
aquatic ecosystems, and protection against adverse effects of NOx
additions (ES-4, Section 1.6, Section 4.5.2, Section 2.2.2, and Section
3.4).

Chapter 2 (Known or Anticipated Ecological Effects)

The panel was generally supportive of the review of effects provided in
the chapter.  The panel asked primarily for clarifications of the text
and additional references.  The panel asked for a summary of the
assumptions and limitations of the steady-state models used in the
ecological effects studies.  The panel requested that we clarify that
ecological effects due to deposition of N and S occur in a relatively
small set of sensitive ecosystems, rather than throughout all
ecosystems.  The panel also asked for a more thorough discussion of
uncertainties, with justifications for rankings of uncertainties, and
sensitivity analyses for the different models used for aquatic
acidification.

Changes made in chapter 2 in the second draft Policy Assessment were
primarily focused on streamlining the chapter as well as on improving
and clarifying the approach for characterizing uncertainty.  In
addition, we included a new table (Table 2-2) that summarizes the
assumptions and limitations of the ecological effects models.

Chapter 3 (Considerations of Adversity to Public Welfare)

The panel asked for a more focused discussion on how and why the current
effects of SOx/NOy deposition on sensitive ecosystems matter in terms of
services and functions of ecosystems that are important to people,
emphasizing that effects occur only in a limited set of sensitive areas.
The panel asked for more explanation of the policy implications of the
monetary values of ecosystem services discussed in the chapter. The
panel also asked for a table summarizing the monetary valuation
associated with various ecosystem services estimates.  The panel asked
for more focus on the effects that are likely occurring due to NOx and
SOx deposition and less on those that potentially could be affected.
The panel also asked for greater acknowledgement of the potential
beneficial effects of nitrogen inputs to nutrient limited ecosystems.

Change made in chapter 3 in the second draft Policy Assessment were
focused on describing those ecosystem services that were likely impacted
by current NOx and SOx deposition.  In addition, we have expanded the
discussion of insights that can be gained by evaluating public
decisionmaking regarding protection of aquatic resources (Section
<IP_ADDRESS>.3), and through evaluation of programs in Europe that have
established targets for ecosystem protection as part of critical loads
policies (Section <IP_ADDRESS>.4).  We have modified Figures 3.4 and 3.5 to
include deposition levels in a wider range of public lands, including
Federal Class I Areas, as well as state and local parks and wilderness
areas.  We have added an additional assessment of the value of decreases
in acidification in the Adirondacks based on the Banzhaf et al (2006)
valuation survey of NY residents (Section 3.4.2).  We have added a
number of additional tables, including a summary of values of ecosystem
services affected by current N deposition (Table 3-7 and 3-8).  We have
included a discussion of the potential beneficial effects of N
deposition in nitrogen-limited areas in Chapter 4, and have added a
clarification to this chapter acknowledging these effects and
reiterating our focus on adverse effects (Section 3.4.5).

Chapter 4 (Addressing the Adequacy of the Current Standards)

The panel was generally supportive of the information provided
demonstrating that current NOx and SOx secondary standards are not
adequate to protect against effects of deposition of NOx and SOx to
sensitive ecosystems.  While the panel agreed that steady state models
are appropriate to evaluate the adequacy of the standards, they note
that approach could be enhanced by also applying dynamic acidification
modeling techniques to “hindcast”changes in ANC.  The panel
recommended that the evaluation of adequacy should consider the extent
to which and rates at which some less sensitive systems may continue to
recover at current S + N deposition, while other more sensitive systems
will not recover or may experience further deterioration.  The panel
also asked for additional plots showing the relationship of NOy to NOx,
compared with NO2 to NOx.  The panel also asked that a summary of the
performance assessment of CMAQ be included.

The performance assessment of CMAQ has been incorporated in the new
Chapter 7 addressing uncertainty, variability, and sensitivity.  Much of
the monitoring discussion has been moved to a separate Chapter 8 on
monitoring issues, and that chapter also provides more discussion on the
ambient concentration to deposition relationship of individual sulfur
and nitrogen species.   New plots of NOy to NOx and NO2 to NOx have been
added to chapter 4.

While the panel recognized that the current review was focused on
sensitive, non-managed ecosystems, the panel requested more discussion
of fertilization effects.  In response to these comments an additional
discussion has been added to Chapter 4 (Section 4.5.2) regarding
nutrient enrichment effects in both managed and non-managed systems.  In
addition, language has been added in several other chapters highlighting
the range of potential responses to nitrogen nutrient enrichment in
different types of ecosystems, especially in N-limited ecosystems.

Chapters 5 (Conceptual Design of an Ecologically Relevant
Multi-pollutant Standard) and 6 (Options for Elements of a Standard to
Protect Against Effects from Aquatic Acidification)

Note:  We have combined Chapters 5 and 6 from the first draft Policy
Assessment into a single Chapter 5 in the second draft Policy Assessment
to reduce redundancy and improve the flow of the document.

The panel was generally supportive of both the conceptual framework
developed to address effects associated with deposition of NOx and SOx,
and the Atmospheric Acidification Protection Index introduced as a new
form of the standards.  The panel agreed with selection of NOy and SOx
as atmospheric indicators, and with the selection of ANC as the
ecological indicator.  The panel agreed that a multi-year averaging time
from 3 to 5 years was appropriate.  The panel also agreed that a
multipollutant standard is appropriate to protect aquatic ecosystems
from acid deposition.

The panel asked that reduced nitrogen be treated as a variable component
of the AAPI standard that can be updated.  The panel asked that the
underlying assumption of steady state behavior should be evaluated with
a parallel effort using sensitivity analysis and dynamic modeling.  The
panel asked that the AAPI equation for the proposed standard should
include the geographical extent and numerical range of its
applicability.  The panel recommended that the mass balance approach to
determining Neco be used over the dynamic modeling approach.  The panel
recommended that in evaluating methods for aggregating catchment scale
critical loads, consideration be given to approaches by which the water
bodies within any specified area could be first stratified to include
only those which were considered potentially susceptible to
acidification, based on estimates of preindustrial ANC, or acid
sensitivity class.  The panel advised EPA to focus on an AAPI standard
driven by aquatic effects concerns, given both the availability of data,
and the likelihood that such a standard would decrease N and S inputs to
ecosystems, which would provide protection against additional effects.
The panel recommended that EPA conduct a sensitivity study to
characterize uncertainty associated with different components of the
conceptual framework and propagate the resulting uncertainty at every
step to arrive at an ensemble of SOx and NOy response surfaces to meet a
given standard.  The panel asked for inclusion of a separate conceptual
diagram which shows the important contributing factors for each term in
the AAPI equation.

The panel noted a number of challenges in specifying the AAPI form.  The
panel highlighted a number of areas of uncertainty, including

Uncertainty in pre-industrial levels of ANC

Uncertainty in the use of steady state models

Uncertainty in the atmospheric deposition transformation ratios

Uncertainty in modeled estimates of reduced nitrogen deposition

In addition, the panel recommended that close attention be given to the
issue of matching temporal and spatial scales in various components of
the AAPI.

The panel recommended disaggregating the g(·) term in the AAPI
equation, and include a term to account for naturally occurring organic
acids.  The panel recommends that consideration of chronically acidic or
highly acid sensitive surface waters that would not be recoverable at a
given ANC limit should be given.

The panel recommended that the CMAQ modeling that is used to develop the
atmospheric deposition transformation ratios be evaluated for
sensitivity to emissions and chemistry, and that characterization of the
uncertainties in precipitation and wet deposition be included.  The
panel recommended several specific evaluations of CMAQ, including:

Model performance for nitric oxide, nitrogen dioxide, sulfur dioxide,
nitrate, ammonium and aerosol nitrate, ammonium, and sulfate for
different networks for which the data are routinely available

Model performance for wet deposition of sulfate, nitrate, and ammonium
using the National Atmospheric Deposition Program (NADP) network

A regional model evaluation using the continuous measurements of nitric
oxide, nitrogen dioxide, nitric acid and NOY from the SEARCH network in
the southeastern U.S.

The panel expressed support for the use of NOx/SOx tradeoff curves, but
recommended that these curves include the impact of reduced nitrogen.

In response to the comments from the panel, Chapter 5 has been revised
in the following ways:

We have added a section comparing critical loads calculated using
steady-state versus dynamic modeling has been added (<IP_ADDRESS>).

The mass balance approach to determining Neco has been used (5.3.2).

The tradeoff curves now show the impact of NHx, based on a range of NHx
deposition values which are modeled to occur across the U.S. (5.3.9).

Criteria have been identified to only consider critical loads from
catchments that are susceptible to acidification from atmospheric
deposition, while excluding those catchments in which acidification
results from high organic acid content, acid mine drainage or naturally
low base cation weathering (<IP_ADDRESS>).

The focus of the conceptual design is on aquatic acidification (5.3.1)
with co-protection to other effects presented in Chapter 6.

A new conceptual diagram has been added that outlines each step to
develop the tradeoff curves and the AAPI (5.3.1)

The g(·) term from the first draft PA has been disaggregated so that
each component is represented in the AAPI equation (5.3.4).  As stated
above, the critical load dataset is screened to exclude those catchments
which would not be able to recover based on pre-industrial ANC values
(<IP_ADDRESS>).

Chapter 7 (Co-protection)

Note:  The chapter on co-protection is now Chapter 6.

The panel supported evaluation of co-protection provided by an aquatic
acidification based standard for terrestrial acidification endpoints and
terrestrial and aquatic nutrient enrichment endpoints.  The panel
recommended that the chapter be expanded to better explain the potential
interrelationships between aquatic and related terrestrial responses to
acidification.  The panel recommended that further consideration not be
given to developing a single standard addressing both acidification and
nutrient enrichment.

Chapter 9 (Conclusions)

The panel generally supported the preliminary staff conclusions
regarding the adequacy of existing standards, and options for the
indicators, averaging times, and form of additional standards to protect
against the effects of NOx and SOx deposition to sensitive aquatic
ecosystems.  The panel reiterated the request for a separate uncertainty
chapter.  They also asked that discussions of future research needs be
linked to the identification of critical uncertainties.

Chapter 9 has been expanded to include a discussion of staff conclusions
regarding the options for elements of the standard.  We have included
discussions of how critical uncertainties might influence the AAPI, with
references to the broader uncertainty discussions in Chapter 7.
Research needs are discussed briefly in the new Chapter 7, but will need
to be more fully developed in the final PA.

 Russell, A. and Samet, J. (2010). Letter from Clean Air Scientific
Advisory Committee to the Honorable Lisa P. Jackson, Administrator, US
EPA. Review of the Policy Assessment for the Review of the Secondary
National Ambient Air Quality Standards for NOx and SOx: First Draft
(March 2010).  June 22, 2010.