[Federal Register Volume 82, Number 114 (Thursday, June 15, 2017)]
[Notices]
[Pages 27492-27493]
[FR Doc No: 2017-12446]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2683]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Data To Support
Social and Behavioral Research as Used by the Food and Drug
Administration

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Fax written comments on the collection of information by July
17, 2017.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910--NEW and
``Data to Support Social and Behavioral Research as Used by the Food
and Drug Administration.'' 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, 10A63, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
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.

Data To Support Social and Behavioral Research as Used by the Food and
Drug Administration--OMB Control Number 0910--NEW

    Understanding patients, consumers, and health care professionals'
perceptions and behaviors plays an important role in improving FDA's
regulatory decisionmaking processes and communications impacting
various stakeholders. The methods to be employed to achieve these goals
include individual indepth interviews, general public focus group
interviews, intercept interviews, self-administered surveys, gatekeeper
surveys, and focus group interviews. The methods to be used serve the
narrowly defined need for direct and informal opinion on a specific
topic and as a qualitative and quantitative research tool, and have two
major purposes:
    (1) To obtain information that is useful for developing variables
and measures for formulating the basic objectives of social and
behavioral research; and
    (2) To assess the potential effectiveness of FDA communications,
behavioral interventions, and other materials in reaching and
successfully communicating and addressing behavioral change with their
intended audiences.
    FDA will use these methods to test and refine its ideas and to help
develop communication and behavioral strategies research, but will
generally conduct further research before making important decisions
such as adopting new policies and allocating or redirecting significant
resources to support these policies.
    FDA's Center for Drug Evaluation and Research, Center for Biologics
Evaluation and Research, Office of the Commissioner, and potentially
other Agency components will use this mechanism to test communications
and social and behavioral methods about regulated drug products on a
variety of subjects related to consumer, patient, or health care
professional perceptions, beliefs, attitudes, behaviors, and use of

drug and biological products and related materials, including, but not
limited to, social and behavioral research, decisionmaking processes,
and communication and behavioral change strategies.
    Annually, FDA estimates about 45 social and behavioral studies
using the variety of test methods listed in this document. FDA is
requesting this burden so as not to restrict the Agency's ability to
gather information on public sentiment for its proposals in its
regulatory and communications programs.
    In the Federal Register of September 19, 2016 (81 FR 64166), FDA
published a 60-day notice requesting public comment on the proposed
extension of this collection of information. No comments were received
in response to the notice.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                  Number of
                   Activity                       Number of     responses per   Total annual          Average burden per response           Total hours
                                                 respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Interviews/Surveys...........................           2,520            14.6          36,792  0.25 (15 minutes)........................           9,198
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: June 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12446 Filed 6-14-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 40 (Monday, March 2, 2015)]
[Notices]
[Pages 11246-11250]
[FR Doc No: 2015-04188]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74362; File No. SR-ICEEU-2015-005]

Self-Regulatory Organizations; ICE Clear Europe Limited; Notice
of Filing of a Proposed Rule Change Relating to CDS Procedures for CDX
North America Index CDS Contracts

February 24, 2015.
    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 February 12, 2015, ICE Clear Europe Limited (``ICE Clear Europe'')
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 primarily by ICE Clear Europe. The Commission
is publishing this notice to solicit comments on the proposed rule
change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The principal purpose of the proposed rule change is to amend the
ICE Clear Europe CDS Procedures (the ``CDS Procedures'') to incorporate
contract terms for the CDX North America index CDS contracts (the

``CDX.NA Contracts'') to be cleared by ICE Clear Europe.

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

    In its filing with the Commission, ICE Clear Europe included
statements concerning the purpose of and basis for the proposed rule
change. The text of these statements may be examined at the places
specified in Item IV below. ICE Clear Europe 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
    ICE Clear Europe submits proposed amendments to its CDS Procedures
to (i) revise the CDS Procedures to add a new section containing
contract terms applicable to the CDX.NA Contracts that ICE Clear Europe
proposes to accept for clearing; (ii) make conforming changes
throughout the CDS Procedures to reference the CDX.NA Contracts; and
(iii) make certain other clarifications, corrections and updates to the
CDS Procedures (including for iTraxx Contracts and Single Name
Contracts), as discussed in more detail herein. ICE Clear Europe also
proposes to make certain modifications to its CDS Risk Model
Description and CDS End-of-Day Price Discovery Policy (the ``CDS
Pricing Policy'') to accommodate clearing of CDX.NA Contracts, as
described herein.
    ICE Clear Europe proposes to amend Paragraphs 1, 4, 6, 9, 10 and 11
of the CDS Procedures. Each of these changes is described in detail as
follows. All capitalized terms not defined herein are defined in the
ICE Clear Europe Clearing Rules (the ``Rules'').
    In paragraph 1 of the CDS Procedures, references have been added to
the defined terms ``iTraxx Contract'' and ``CDX.NA Contract,'' as such
terms are set out in revised paragraphs 9 and 10 of the CDS Procedures,
respectively. The definition of ``Original Annex Date'' has been
modified to apply to CDX.NA Contracts in substantially the same manner
it applies to iTraxx Contracts. In addition, the definition of
``Protocol Excluded Reference Entity'' in former paragraph 10.3 has
been changed to ``Protocol Excluded Corporate Reference Entity'' and
moved to paragraph 1, to reflect that such term is only used in the
context of corporate reference entities. Accordingly, the definition
has been revised to mean an Eligible Single Name Reference Entity that
is a Standard European Corporate (as specified in the List of Eligible
Single Name Reference Entities) and is an Excluded Reference Entity (as
defined in the 2014 CDD Protocol). (Conforming changes have been made
to references to that definition throughout the CDS Procedures.) In
addition, a correction has been made to the cross-reference in
definition of ``New Trade'' to properly refer to the definition set out
in the applicable Contract Terms for the relevant contract.
    In addition, amendments were also made to use the defined terms
``Component Transaction'' and ``Clearing'' (each as defined in the ICE
Clear Europe Rules) throughout the Procedures in lieu of the undefined
terms. Finally, various conforming references to the new or revised
defined terms have been made throughout the CDS Procedures, various
provisions of the CDS Procedures have been renumbered, and certain
cross-references to prior paragraph 1.71 have been corrected.
    Various clarifications have been made in Paragraph 9 of the CDS
Procedures, which sets out the contract terms for iTraxx Contracts.
Specifically, paragraph 9.1 was modified to clarify that it specifies
the additional Contract Terms applicable to all iTraxx Contracts
cleared by the Clearing House. Paragraph 9.2(c)(i), which applies to
iTraxx Contracts which are governed by the Standard iTraxx 2014 CDS
Supplement, has been modified to make certain additional clarifications
relating to initial payments and spun-out trades. Paragraph
9.2(c)(i)(B) has been added to reflect current clearing house (and
market) practice that initial payments under cleared iTraxx Contracts
(other than those for which a bilateral transaction is already recorded
in Deriv/SERV) are made on the business day following the trade date
(or, if later, the business day following the date of acceptance for
clearing). New paragraph 9.2(c)(i)(D), which addresses the reference
obligation for a spun-out trade following a restructuring credit event,
is substantially the same as the corresponding language in paragraph
9.3(c)(i)(D) for contracts subject to the Standard iTraxx Legacy CDS
Supplement and was inadvertently omitted from prior amendments. A
cross-reference in paragraph 9.2(c)(i)(E) has been updated. New
paragraph 9.2(c)(i)(F) provides that paragraph 5.7 of the Standard
iTraxx 2014 CDS Supplement, which contains restrictions on delivery of
Credit Event Notices and Successor Notices, does not apply to iTraxx
Contracts (as the appropriate restrictions in the context of a cleared
transaction are already addressed in the Rules and CDS Procedures,
including Rule 1505).
    As set forth in paragraph 9.2(c)(ii), changes have also been made
to the terms of the iTraxx 2014 Confirmation with respect to iTraxx
Contracts that are governed by the Standard iTraxx 2014 CDS Supplement.
These amendments include a clarification that references to the 2014
Credit Derivatives Definitions in the standard supplement and
confirmation will be interpreted for cleared contracts as though they
have the meaning ascribed to that term in the Rules and Procedures. In
addition, a provision that there are no ``Omitted Reference Entities''
for purposes of the standard confirmation has been removed as that term
is not used in the standard supplement and confirmation and is
therefore unnecessary.
    Similar clarifications have been made in paragraph 9.3, which
relates to iTraxx Contracts which are governed by the Standard iTraxx
Legacy CDS Supplement. Specifically, new paragraph 9.3(c)(i)(B)
contains the same clarification discussed above with respect to the
initial payment date for a contract. Paragraph 9.3(c)(i)(D) contains a
correction that the treatment therein of reference obligations for
spun-out trades applies for reference entities subject to both Sections
A and B of the Standard iTraxx Legacy CDS Supplement (that is, both
protocol-excluded and non-excluded entities). Subparagraph (F) provides
that restrictions under the standard supplement as to delivery of
Credit Event Notices and Succession Event Notices do not apply, as the
issue is otherwise addressed under the Rules and CDS Procedures, as
discussed above. In paragraph 9.3(c)(ii)(E), a reference to there being
no ``Omitted Reference Entities'' has also been removed for the reasons
noted above.
    New paragraph 10 of the CDS Procedures has been added to set out
the contract terms for CDX.NA Contracts. Paragraph 10.1 provides that
different sub-provisions of paragraph 10 will apply to CDX.NA Contracts
depending on whether the Original Annex Date for the relevant index
series falls before or after the Protocol Effective Date.
    New paragraph 10.2 applies to CDX.NA Contracts with an Original
Annex Date on or after the Protocol Effective Date (i.e., for
transactions in the September 2014 or later versions of the index). New
definitions have been added to subparagraph (a), including definitions
for ``CDX.NA Contract'',

``CDX.NA Publisher'', ``CDX.NA Terms Supplement'', ``Eligible CDX.NA
Index'', ``List of Eligible CDX.NA Indices'', and ``Relevant CDX.NA
Terms Supplement'', which largely track the analogous definitions in
paragraph 9 with respect to iTraxx Europe Contracts. Paragraph 10.2(b)
incorporates defined terms from the Relevant CDX.NA Terms Supplement
and also contains an inconsistency provision which provides that
paragraph 10.2 governs over the CDX.NA 2014 CDS Supplement and CDX.NA
2014 Confirmation. Paragraph 10.2(c) contains certain amendments to the
Standard CDX.NA 2014 CDS Supplement and CDX.NA 2014 Confirmation, which
are generally consistent with the amendments to the iTraxx 2014 Terms
Supplement and iTraxx 2014 Confirmation in paragraph 9.2(c) and are
generally designed to accommodate the requirements of clearing and make
the standard contract terms consistent with the Rules and Procedures.
In addition, paragraph 10.2(c)(i)(E) addresses the application of the
defined term ``Index Party'' in the standard supplement in the context
of a cleared transaction, and paragraphs 10.2(c)(ii)(E)-(F) have been
added to refer to certain transaction terms specified in the List of
Eligible CDX.NA Indices for the relevant index and tenor. Paragraph
10.2(c)(i)(G) clarifies that as with iTraxx Contracts, de minimis cash
settlement under the standard supplement does not apply. Paragraph
10.2(c) also indicates the transaction terms that must be specified in
the submission of a trade for clearing.
    New paragraph 10.3 applies to CDX.NA Contracts with an Original
Annex Date before the Protocol Effective Date (i.e., for transactions
in older versions of the index). Paragraph 10.3 contains definitions
and provisions generally similar to those in paragraph 10.2, and makes
comparable amendments to the Standard CDX.NA Legacy CDS Supplement and
the CDX.NA Legacy Confirmation.
    New paragraph 10.4 contains procedures for updating the CDX.NA
index version following a Credit Event or Succession Event. These
provisions are generally consistent with the comparable provisions for
iTraxx contracts in paragraph 9.8. New paragraph 10.4(b) adds a similar
procedure for implementing a new version of the CDX.NA standard terms
supplement, if and when published, where contracts referencing the old
and new versions of the supplement are determined by the Clearing House
to be fungible.
    Existing paragraph 10, which contains contract terms for Single
Name Contracts, has been renumbered as paragraph 11 and cross
references have been updated accordingly. In addition, various
clarifying amendments have been made to this paragraph. The definitions
of ``STEC Contract'' and ``Non-STEC Single Name Contract'' have been
amended to clarify that the relevant Reference Entity type will be
specified in the List of Eligible Single Name Reference Entities. The
definition of ``Single Name Contract Reference Obligations'' has been
amended to clarify that the applicable reference obligation will be
specified in the List of Eligible Single Name Reference Entities and
may differ between 2003-type CDS Contracts and 2014-type CDS Contracts.
For 2014-type CDS Contracts, the reference obligation may be designated
as the Senior Level Standard Reference Obligation that is specified
from time to time on the SRO List published under the 2014 ISDA
Definitions.
    Paragraph 11.6(a)(i)(C) is amended by adding a subsection (2) that
makes a clarification as to the initial payment date for Single Name
Contracts that corresponds to the change in payment date discussed
above for iTraxx Contracts. A change is made in paragraph 11.6(a)(ii)
to conform to the changes made to the definition of Single Name
Contract Reference Obligation discussed above.
    In general, the Clearing House's existing risk methodology
applicable to index CDS will also apply to the CDX.NA Contracts.
However, ICE Clear Europe proposes to make certain amendments to its
CDS Risk Model Description and CDS Pricing Policy to address CDX.NA
Contracts.
    In the CDS Risk Model Description, the index decomposition offset
methodology, which is used to determine portfolio margin benefits from
correlated long and short positions, is proposed to be modified to
address multi-region risk factors. Under the revised methodology,
portfolio margin benefits are provided first for risk factors within
the same region. After the same-region risk analysis is completed, any
cross-region benefits for index risk factors are determined. Cross-
region benefits apply only to index risk factors. The revised
description thus addresses scenarios in which margin offsets may be
provided between appropriately correlated positions in iTraxx Contracts
and positions in CDX.NA Contracts. The revisions also provide that
where risk factor profits and losses are calculated in different
currencies, they will be converted into the same base currency (Euro)
for purposes of calculation of portfolio margin benefits.
    ICE Clear Europe also proposes to amend its CDS Pricing Policy to
cover the CDX.NA Contracts. The amendments include submission
requirements with respect to CDX.NA Contracts and changes to reflect
that certain determinations with respect to firm trades for CDX.NA
Contracts are made as of the North American end-of-day.
2. Statutory Basis
    ICE Clear Europe believes that the proposed rule change, and in
particular the proposed clearing of the proposed CDX.NA Contracts, is
consistent with the requirements of Section 17A of the Act \3\ and
regulations thereunder applicable to it, including the standards under
Rule 17Ad-22.\4\ The proposed change is principally designed to permit
the clearing of CDX.NA index CDS Contracts, as well as make certain
clarifications and other amendments to the CDS Procedures applicable to
other CDS Contracts. The CDX.NA Contract is a broad-based index CDS
contract generally similar to the iTraxx Contract currently cleared by
the Clearing House, with similar terms and conditions. The new index
CDS contracts will be cleared in the same manner as the iTraxx
Contracts, consistent with ICE Clear Europe's existing clearing
arrangements and related financial safeguards and protections. In ICE
Clear Europe's view, clearing of the CDX.NA Contracts, under such terms
and arrangements, is consistent with the prompt and accurate clearance
and settlement of securities transactions and derivative agreements,
contracts and transactions cleared by ICE Clear Europe, the
safeguarding of securities and funds in the custody or control of ICE
Clear Europe and the protection of investors and the public interest,
within the meaning of Section 17A(b)(3)(F) of the Act.\5\ The
additional changes set forth in the proposed amendments, which
generally make clarifications and corrections to the CDS Procedures for
existing iTraxx and Single Name Contracts, are also consistent with
this standard.
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    \3\ 15 U.S.C. 78q-1.
    \4\ 17 CFR 240.17Ad-22.
    \5\ 15 U.S.C. 78q-1(b)(3)(F).
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    The proposed amendments to the CDS Procedures, including clearing
of the CDX.NA Contracts, will also satisfy the relevant requirements of
Rule 17Ad-22,\6\ as discussed below.
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    \6\ 17 CFR 240.17Ad-22.
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    Financial Resources. ICE Clear Europe will apply its existing
margin methodology for index CDS contracts to

the CDX.NA Contracts, with the modifications described herein to the
CDS Risk Model Description. In ICE Clear Europe's view, the Clearing
House's margin requirements, as revised, will provide sufficient margin
to cover its credit exposure to its clearing members from clearing such
contracts, consistent with the requirements of Rule 17Ad-22(b)(2) and
Rule 17Ad-22(d)(14).\7\ In addition, ICE Clear Europe believes the CDS
Guaranty Fund, under its existing methodology, will, together with the
required margin, provide sufficient financial resources to support the
clearing of CDX.NA Contracts, consistent with the requirements of Rule
17Ad-22(b)(3).\8\
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    \7\ 17 CFR 240.17Ad-22(b)(2), (d)(14).
    \8\ 17 CFR 240.17Ad-22(b)(3).
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    Operational Resources. ICE Clear Europe will have the operational
and managerial capacity to clear the CDX.NA Contracts as of the
commencement of clearing, consistent with the requirements of Rule
17Ad-22(d)(4).\9\ ICE Clear Europe believes that its existing systems
used for index CDS contracts are appropriately scalable to handle the
clearing of the CDX.NA Contracts.
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    \9\ 17 CFR 240.17Ad-22(d)(4).
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    Settlement. ICE Clear Europe will use its existing settlement
procedures (including for physical settlements), account structures and
approved financial institutions as used in other index CDS for the
CDX.NA Contracts. Although CDX.NA Contracts will be denominated in US
dollars, ICE Clear Europe's existing settlement systems are sufficient
to handle such settlements in such currency. ICE Clear Europe believes
that clearing of such contracts will therefore be consistent with the
requirements of Rule 17Ad-22(d)(5), (12) and (15).\10\
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    \10\ 17 CFR 240.17Ad-22(d)(5), (12) and (15).
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    Default Procedures. ICE Clear Europe's existing Rules and default
management policies and procedures for CDS will apply to the CDX.NA
Contracts. ICE Clear Europe believes that the Rules and procedures
allow for it to take timely action to contain losses and liquidity
pressures and to continue meeting its obligations in the event of
clearing member insolvencies or defaults, including in respect of
CDX.NA Contracts, in accordance with Rule 17Ad-22(d)(11).\11\
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    \11\ 17 CFR 240.17Ad-22(d)(11).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    ICE Clear Europe does not believe the proposed rule change,
including the clearing of the CDX.NA Contracts, would have any impact,
or impose any burden, on competition not necessary or appropriate in
furtherance of the purpose of the Act. ICE Clear Europe does not
anticipate that its commencement of clearing for the CDX.NA Contracts,
or the other amendments with respect to its other CDS contracts, will
adversely affect the trading market for those contracts or for CDS more
generally. Specifically, allowing clearing of the CDX.NA Contracts will
provide market participants with the additional choice to have their
transactions in these types of contracts cleared, and should generally
promote the further development of the market for these contracts. ICE
Clear Europe does not believe that the other amendments will materially
affect the cost of clearing for the relevant contracts or adversely
affect access to clearing in those contracts for Clearing Members or
their customers. Moreover, ICE Clear Europe will apply its existing
fair and objective criteria for eligibility to clear CDS to clearing of
the CDX.NA Contracts. Accordingly ICE Clear Europe does not believe
that the amendments will impose any burden on competition 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

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

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 the 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-SR-ICEEU-2015-005 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
All submissions should refer to File Number SR-ICEEU-2015-005. 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 such filings will also be available
for inspection and copying at the principal office of ICE Clear Europe
and on ICE Clear Europe's Web site at https://www.theice.com/clear-europe/regulation.
    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-ICEEU-2015-005
and should be submitted on or before March 23, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
Jill M. Peterson,
Assistant Secretary.
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    \12\ 17 CFR 200.30-3(a)(12).
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[FR Doc. 2015-04188 Filed 2-27-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 238 (Wednesday, December 13, 2017)]
[Notices]
[Pages 58684-58686]
[FR Doc No: 2017-26867]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2017-0043]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to exempt 31 individuals from the
prohibition in the Federal Motor Carrier Safety Regulations (FMCSRs)
against persons with insulin-treated diabetes mellitus (ITDM) from
operating a commercial motor vehicle (CMV) in interstate commerce. The
exemptions enable these individuals with ITDM to operate CMVs in
interstate commerce.

DATES: The exemptions were applicable on October 20, 2017. The
exemptions expire on October 20, 2019.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER>, [email protected], FMCSA,
Department of Transportation, 1200

New Jersey Avenue SE, Room W64-224, Washington, DC 20590-0001. Office
hours are from 8:30 a.m. to 5 p.m., e.t., Monday through Friday, except
Federal holidays. If you have questions regarding viewing or submitting
material to the docket, contact Docket Services, telephone (202) 366-
9826.

SUPPLEMENTARY INFORMATION:

I. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE,
Washington, DC, between 9 a.m. and 5 p.m., e.t., Monday through Friday,
except Federal holidays.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to http://www.regulations.gov, as described in
the system of records notice (DOT/ALL-14 FDMS), which can be reviewed
at http://www.dot.gov/privacy.

II. Background

    On September 19, 2017, FMCSA published a notice announcing receipt
of applications from 31 individuals requesting an exemption from
diabetes requirement in 49 CFR 391.41(b)(3) and requested comments from
the public (82 FR 43810). The public comment period ended on October
19, 2017, and no comments were received.
    FMCSA has evaluated the eligibility of these applicants and
determined that granting the exemptions to these individuals would
achieve a level of safety equivalent to or greater than the level that
would be achieved by complying with the current regulation 49 CFR
391.41(b)(3).
    The physical qualification standard for drivers regarding diabetes
found in 49 CFR 391.41(b)(3) states that a person is physically
qualified to drive a CMV if that person has no established medical
history or clinical diagnosis of diabetes mellitus currently requiring
insulin for control.

III. Discussion of Comments

    FMCSA received no comments in this proceeding.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the diabetes standard in 49 CFR 391.41(b)(3) if the exemption is
likely to achieve an equivalent or greater level of safety than would
be achieved without the exemption. The exemption allows the applicants
to operate CMVs in interstate commerce.
    The Agency's decision regarding these exemption applications is
based on the program eligibility criteria and an individualized
assessment of information submitted by each applicant. The
qualifications, experience, and medical condition of each applicant
were stated and discussed in detail in the September 19, 2017 Federal
Register notice (82 FR 43810) and will not be repeated in this notice.
    These 31 applicants have had ITDM over a range of 1 to 30 years.
These applicants report no severe hypoglycemic reactions resulting in
loss of consciousness or seizure, requiring the assistance of another
person, or resulting in impaired cognitive function that occurred
without warning symptoms, in the past 12 months and no recurrent (two
or more) severe hypoglycemic episodes in the past five years. In each
case, an endocrinologist verified that the driver has demonstrated a
willingness to properly monitor and manage his/her diabetes mellitus,
received education related to diabetes management, and is on a stable
insulin regimen. These drivers report no other disqualifying
conditions, including diabetes related complications. Each meets the
vision requirement at 49 CFR 391.41(b)(10).
    Consequently, FMCSA finds that in each case exempting these
applicants from the diabetes requirement in 49 CFR 391.41(b)(3) is
likely to achieve a level of safety equal to that existing without the
exemption.

V. Conditions and Requirements

    The terms and conditions of the exemption are provided to the
applicants in the exemption document and includes the following: (1)
Each driver must submit a quarterly monitoring checklist completed by
the treating endocrinologist as well as an annual checklist with a
comprehensive medical evaluation; (2) each driver must report within
two business days of occurrence, all episodes of severe hypoglycemia,
significant complications, or inability to manage diabetes; also, any
involvement in an accident or any other adverse event in a CMV or
personal vehicle, whether or not it is related to an episode of
hypoglycemia; (3) each driver must provide a copy of the
ophthalmologist's or optometrist's report to the Medical Examiner at
the time of the annual medical examination; and (4) each driver must
provide a copy of the annual medical certification to the employer for
retention in the driver's qualification file, or keeping a copy in his/
her driver's qualification file if he/she is self-employed. The driver
must also have a copy of the exemption when driving, for presentation
to a duly authorized Federal, State, or local enforcement official.

VI. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VII. Conclusion

    Based upon its evaluation of the 31 exemption applications, FMCSA
exempts the following drivers from the diabetes requirement in 49 CFR
391.41(b)(10), subject to the requirements cited above:

Valerian J. Ahles (MN)
Gabriel P. Aranda (ID)
Herbert M. Boggs, Sr. (VA)
Samuel D. Chadwick (NY)
Michael J. Coopey (NJ)
David A. Dworak (WI)
Francis G. Gahr (PA)
Robert Giordano (NJ)
John W.E. Haddad (VA)
Anthony W. Hartley (ME)
Shay S. Hobbs (AL)
Jack T. Jaworski (NY)
Mark E. Jernstad (IL)
Kenneth F. Julius (MN)
Timothy D. Kinsey (SC)
Fred A. Klein (MT)
Kenneth C. Knighten (OR)
Thomas R. Ligman (PA)
Richard A. Miller (PA)
Thomas J. Miller, Jr. (NC)
Danny L. Nelson (MA)
James D. Northum (TX)
Everett M. Ortiz (OR)
Rodney D. Rexford (NH)
Michael K. Richardson (SC)
Daniel L. Richardson, Sr. (MD)
Eliezer Rivera-Nieves (CT)
Jacob D. Savage (TN)
Jamesha K. Thomas (SC)
Stephen M. Ward (MA)
Robert A. Young (TN)

    In accordance with 49 U.S.C. 31136(e) and 31315, each exemption
will be valid for two years from the effective date unless revoked
earlier by FMCSA. The exemption will be revoked if the following
occurs: (1) The person fails to

comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
prior to being granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136(e) and
31315.

    Issued on: December 6, 2017.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2017-26867 Filed 12-12-17; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register: June 20, 2008 (Volume 73, Number 120)]
[Notices]
[Page 35130-35131]
[DOCID:fr20jn08-45]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

June 16, 2008.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:
    Docket Numbers: RP96-200-192.
    Applicants: CenterPoint Energy Gas Transmission Co.
    Description: CenterPoint Energy Gas Transmission Co. submits two
negotiated rate agreements with Connect Energy Services, LLC.
    Filed Date: 06/13/2008.
    Accession Number: 20080613-0074.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 25, 2008.

    Docket Numbers: RP08-358-001.
    Applicants: CenterPoint Energy Gas Transmission Co.
    Description: CenterPoint Energy Gas Transmission Co. submits
Substitute Thirteenth Revised Sheet 32 et al. to FERC Gas Tariff, Sixth
Revised Volume 1 to comply with the Commission's Letter Order issued on
5/29/08, effective 6/1/08.
    Filed Date: 06/13/2008.
    Accession Number: 20080616-0001.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 25, 2008.

    Docket Numbers: RP08-360-001.
    Applicants: Northern Natural Gas Company.
    Description: Northern Natural Gas Co. submits supportive
information in compliance with FERC's 5/29/08 Order.
    Filed Date: 06/11/2008.
    Accession Number: 20080612-0201.
    Comment Date: 5 p.m. Eastern Time on Monday, June 23, 2008.

    Docket Numbers: RP08-340-001.
    Applicants: Cheyenne Plains Gas Pipeline Company LLC.
    Description: Cheyenne Plains Gas Pipeline Company, LLC's compliance
filing of workpapers in support of the fuel gas and lost and
unaccounted for gas reimbursement percentages.
    Filed Date: 06/12/2008.
    Accession Number: 20080613-0075.
    Comment Date: 5 p.m. Eastern Time on Tuesday, June 24, 2008.

    Docket Numbers: RP08-404-000.
    Applicants: Williston Basin Interstate Pipeline Co.
    Description: Williston Basin Interstate Pipeline Co. submits
Fourteenth Revised Sheet 376 and 376A to FERC Gas Tariff, Second
Revised Volume 1, to become effective 6/10/08.
    Filed Date: 06/10/2008.
    Accession Number: 20080611-0128.
    Comment Date: 5 p.m. Eastern Time on Monday, June 23, 2008.

    Docket Numbers: RP08-405-000.
    Applicants: National Fuel Gas Supply Corporation.
    Description: Petition of National Fuel Gas Supply Corp. for Waiver
of Tariff Provisions.
    Filed Date: 06/10/2008.
    Accession Number: 20080611-0129.
    Comment Date: 5 p.m. Eastern Time on Monday, June 23, 2008.

    Docket Numbers: RP08-406-000.
    Applicants: El Paso Natural Gas Company.
    Description: El Paso Natural Gas Co submits a request for waiver of
Section 5.1(a) of the General Terms and Conditions re FERC Gas Tariff,
Second Revised Volume 1A.
    Filed Date: 06/11/2008.
    Accession Number: 20080612-0202.
    Comment Date: 5 p.m. Eastern Time on Monday, June 23, 2008.

    Docket Numbers: RP08-407-000.
    Applicants: El Paso Natural Gas Company.
    Description: El Paso Natural Gas Co submits Fifth Revised Sheet 226
to FERC Gas Tariff, Second Revised Volume 1A, to become effective on 7/
14/08.
    Filed Date: 06/11/2008.
    Accession Number: 20080612-0203.
    Comment Date: 5 p.m. Eastern Time on Monday, June 23, 2008.

    Docket Numbers: RP08-408-000.
    Applicants: Saltville Gas Storage Company L.L.C.

    Description: Saltville Gas Storage Company, LLC submits First
Revised Sheet 3 to FERC Gas Tariff, Original Volume 1, to become
effective 7/12/08.
    Filed Date: 06/12/2008.
    Accession Number: 20080613-0007.
    Comment Date: 5 p.m. Eastern Time on Tuesday, June 24, 2008.

    Docket Numbers: RP08-358-001.
    Applicants: CenterPoint Energy Gas Transmission Co.
    Description: CenterPoint Energy Gas Transmission Co submits
Substitute Thirteenth Revised Sheet 32 et al to FERC Gas Tariff, Sixth
Revised Volume 1 to comply with the Commission's Letter Order issued on
5/29/08, effective 6/1/08.
    Filed Date: 06/13/2008.
    Accession Number: 20080616-0001.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 25, 2008.
    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
 [FR Doc. E8-13904 Filed 6-19-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: December 14, 2009 (Volume 74, Number 238)]
[Rules and Regulations]
[Page 66047-66048]
[DOCID:fr14de09-10]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2009-N-0665]

Implantation or Injectable Dosage Form New Animal Drugs; Insulin

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule.

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

SUMMARY:  The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of an original new animal drug
application (NADA) filed by Boehringer Ingelheim Vetmedica, Inc. The
NADA provides for veterinary prescription use of an injectable
suspension of protamine zinc recombinant human insulin for the
reduction of hyperglycemia and hyperglycemia-associated clinical signs
in cats with diabetes mellitus.

DATES:  This rule is effective December 14, 2009.

FOR FURTHER INFORMATION CONTACT:  Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Boehringer Ingelheim Vetmedica, Inc., 2621
North Belt Highway, St. Joseph, MO 64506-2002, filed NADA 141-297 that
provides for the veterinary prescription use of PROZINC (protamine zinc
recombinant human insulin), an injectable suspension for the reduction
of hyperglycemia and hyperglycemia-associated clinical signs in cats
with diabetes mellitus. The NADA is approved as of October 28, 2009,
and the regulations are amended in 21 CFR 522.1160 to reflect the
approval.
    In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support approval of
this application may be seen in the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.33 that this action is of
a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 522

    Animal drugs.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 522 continues to read as
follows:

    Authority:  21 U.S.C. 360b.

0
2. In Sec.  522.1160, revise paragraphs (a), (b), and (c)(2)(i) to read
as follows:

Sec.  522.1160   Insulin.

    (a) Specifications--(1) Each milliliter (mL) of porcine insulin
zinc suspension contains 40 international units (IU) of insulin.
    (2) Each mL of protamine zinc recombinant human insulin suspension
contains 40 IU of insulin.
    (b) Sponsors. See sponsors in Sec.  510.600 of this chapter for use
as in paragraph (c) of this section.
    (1) No. 000061 for use of product described in paragraph (a)(1) of
this section as in paragraphs (c)(1), (c)(2)(i)(A), (c)(2)(ii), and
(c)(2)(iii) of this section.
    (2) No. 000010 for use of product described in paragraph (a)(2) of
this section as in paragraphs (c)(2)(i)(B), (c)(2)(ii), and (c)(2)(iii)
of this section.
    (c) * * *
    (2) Cats--(i) Amount--(A) Porcine insulin zinc. Administer an
initial dose of 1 to 2 IU by subcutaneous injection. Injections should
be given twice daily at approximately 12-hour intervals. For cats fed
twice daily, the injections should be concurrent with or right after a
meal. For cats fed ad libitum, no change in feeding is needed. Adjust
the dose at appropriate intervals based on clinical signs, urinalysis
results, and glucose curve values until adequate glycemic control has
been attained.
    (B) Protamine zinc recombinant human insulin. Administer an initial
dose of 0.1 to 0.3 IU/pound of body weight (0.2 to 0.7 IU/kilogram)
every 12 hours. The dose should be given concurrently with or right
after a meal. Re-evaluate the cat at appropriate intervals and adjust
the dose based on both clinical signs and glucose nadirs until adequate
glycemic control has been attained.
* * * * *

    Dated: December 8, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-29583 Filed 12-11-09; 8:45 am]

BILLING CODE 4160-01-S


Steam Electric Data Request Follow-Up Questions

Project Name:  Steam Electric Detailed Study

	Project No.:  0<IP_ADDRESS>

Company Name:  Georgia Power

	Contact Name:  William R. Evans

Plant Name:  Plant Scherer	Contact Phone Number:<PHONE_NUMBER>

or Email Address<EMAIL_ADDRESS>
ERG Staff (or ERG Rep) Name: Sarah Holman

Company Affiliation: ERG	Date: 12/19/07

This document contains CBI:   ___  Yes      x     No

	Type of  Contact:     x      Email       x    Telephone

General Subject:  Data Request Assistance / Follow-Up

Follow-Up Question Number	CBI =

Yes (Y)

No (N)	Data Request Question Number	Data Request Page Number

Question/Answer

1	N	8	B-3	Q: There is no energy source indicated for Unit 2.  Please
confirm that this unit uses coal as its only energy source.

A:  Confirmed.

2	N	11	B-8	Q: Frequency of drainage from coal pile is given as 365 days.
 Does the plant have an estimation of the actual number of days of
drainage from the coal pile, or an estimation of the number of days of
rain in 2006?

A:  Mr. Evans believes that the coal pile is so large that there is
likely continuous drainage from the coal pile to the coal pile runoff
pond.  Water is pumped continuously from the coal pile runoff pond, and
the plant used that flow rate for the estimate of drainage into the
pond.

3	N	11	B-8	Q: At Plant Scherer, the amount of coal pile runoff is
significantly higher than at Plant Wansley (even after accounting for
the difference in coal burned in 2006).  What is the reason for this
difference?

A:  The main difference is likely that Plant Scherer has a larger area
from which coal pile runoff is collected.  Coal pile runoff drains from
areas adjacent to the coal pile, such as the truck areas.   This is
reflected in the Outfalls 03H and 03D.

4	N	16	B-10	Q: “Type of Fly Ash Collection System” is listed as both
ESP, cold side and Other, “Dry” for each of the four units.  Does
“Dry” refer to the method of handling the fly ash?  Do the four
units only use a cold-side ESP to collect fly ash?

A:  Yes.  Yes.

5	N	16	B-10	Q: “Type of Fly Ash Handling System” is listed as both
wet and dry.  What is the approximate percentage of the time that the
fly ash is handled in a dry fashion?

A:  85% of the fly is handled dry and sold.  The rest of the fly ash is
sluiced, and sluicing is continuous 24 hpd, 365 dpy.  The tpd of ash
provided in Table 5 includes the fly ash sold and sluiced.

6	N	16	B-10	Q: “Percent Contribution of Source to Sluice Water Flow”
is listed as 100% FAS for each of the four units.  Please confirm that
the FAS sluice system is entirely close-looped and does not require any
makeup water.

A:  Enough rain water enters the ash pond that the recycle water from
the ash pond is clean enough for ash sluicing, and makeup water is not
typically necessary.

7	N	18	B-12	Q: “Percent Contribution of Source to Sluice Water Flow”
is listed as 100% BAS for each of the four units.  Confirm that the BAS
sluice system is entirely close-looped and does not require any makeup
water.

A:  Enough rain water enters the ash pond that the recycle water from
the ash pond is clean enough for ash sluicing, and makeup water is not
typically necessary.

8	N	30	B-20	Q: The plant responded that it is currently
constructing/installing a wastewater treatment system to treat the
wastewater from the new FGD system; however, from the plant’s
description of the treatment system, it seems that the settling pond
under construction is just for solids removal of gypsum sluice (and
treatment of recycle bleed-off, defined in the data request as
“scrubber purge”, will occur in the existing ash pond).  Please
confirm that this is the case.

Additionally, the plant’s response to “Will the wastewater treatment
system treat FGD wastewater that is commingled with ash wastewater prior
to treatment” is no; however, from the plant’s explanation of the
wastewater treatment system, it seems that FGD wastewater and ash
wastewater will be commingled prior to treatment in the ash pond.
Please explain the response to this question.

A:  Confirmed.  Unlike at Plant Yates, at Plant Scherer, the chlorides
level will be of concern (because the scrubber is not constructed of
exotic materials like at Plant Yates), so there will be continuous
bleed-off from the scrubber recycle to the ash pond.

9	N	43	B-26	Q: Outfalls 01C - 01E, 02A, 02B, 03A – 03C, 03F – 03H,
and 04-14 are not listed in Table 14 or the process diagrams.  Did they
discharge in 2006?  Should the coal pile runoff stream be labeled as 03H
in Diagram 5-3 (currently no label)?

A:  See attached table.

Outfall 03H is effluent from the coal pile runoff pond and 03D is the
combination of 03H and other coal pile-related wastewaters, such as
water from belts and drains adjacent to the coal pile.

10	N	47	B-28	Q: For WWT-1 (Diagram 5-1), please confirm that pH
adjustment occurs within (as part of) the ash pond and not within a
separate tank/pond as indicated in the diagram.

A:  Confirmed.

11	N	47	B-28	Q: On Diagram 5-1, there is more wastewater shown entering
the ash pond than exiting.  Please confirm that the reason for this is
evaporation.

A:  The reason is a combination of evaporation and rain water entering
the pond.  The area around the pond is a large watershed area.

12	N	47	B-28	Q: On Diagram 5-1, the flow rate presented for FAS is
27,300 gpm, whereas in Question 16, the total FAS flow rate provided is
27,523 (and the FAS flow rate provided in Question 52 is 27,500 gpm).
Please explain the difference.  Which flow rate is more accurate?

A:  The response to Question 16 is most accurate.

13	N	47	B-28	Q: On Diagram 5-1, the flow rate presented for BAS is 4,800
gpm, whereas in Question 18, the total BAS flow rate provided is 3,885
gpm.  Please explain the difference.  Which flow rate is more accurate?

A:  The response to Question 18 is more accurate.

14	N	47	B-28	Q: On Diagram 5-1, the flow rate presented for PMRS is 900
gpm, whereas in Question 13, the PMRS flow rate provided is 971 gpm.
Please explain the difference.  Which flow rate is more accurate?

A:  The response to Question 13 is more accurate.

15	N	47	B-28	Q: Regarding Diagram 5-1, please confirm that no wastewater
treatment occurs in the Low Volume Waste Basin.

A:  Confirmed.

16	N	47	B-28	Q: For WWT-2 (Diagram 5-2), please confirm that pH
adjustment and chemical precipitation occur within the settling pond and
not within separate vessels as shown on the diagram?

What chemicals are typically added to the settling pond for chemical
precipitation?  Were any of these chemicals added in 2006 (none are
listed in Question 51)?

A:  Confirmed.  The plant has added “advanced chemicals” to the
settling pond in the past, but did not add any chemicals in 2006.

17	N	47	B-28	Q: What is the volume and frequency of CMCW entering the
Metal Cleaning Waste Basin (WWT-2)?

A:  No CMCW entered the WWT-2 basin in 2006.  The plant only pumped
water out of the basin for about four days in 2006.

18	N	49	B-32	Q: The “Residence Time of Wastewater in Unit” is listed
as “Indefinite – multiple years”.  Please explain this response.

A:  The best answer is “indefinite” because water is only pumped out
when necessary and there are often years inbetween pumping episodes.

19	N	51	B-33	Q: For WWT-1, the “Average Dose Concentration” of
sulfuric acid is listed as “Not measured – varies as necessary for
pH”.  As requested in EPA’s email to UWAG on 7/11/07, please provide
the concentration of the active ingredient added (i.e., the amount of
active ingredient contained in the chemical product).

A:  93% sulfuric acid.

20	N	52	B-34	Q: For WWT-1, [WWT-1-EFF to SW] is listed as 14,000 gpm in
Question 52, but is presented as 6,600 gpm in Diagram 5-1.  Please
confirm that the effluent from the WWT-1 settling pond is 6,660 gpm
(prior to the addition of cooling water blowdown).

A:  Confirmed.

21	N	52	B-34	Q: For WWT-1, did FAS, BAS, and PMRS enter the ash pond 24
hpd and 365 dpy?  Was the recycle from the ash pond used for RECYC-FAS,
RECYC-BAS, and RECYC-PMRS 24 hpd and 365 dpy?

A:  Yes.  Yes.

22	N	53	B-35	This information has been removed because it contains
confidential business information (CBI) per 40 CFR Part 2, Subpart B.
This information can be found in the confidential record.

23	N	53	B-35	This information has been removed because it contains
confidential business information (CBI) per 40 CFR Part 2, Subpart B.
This information can be found in the confidential record.

24	N	53	B-35	This information has been removed because it contains
confidential business information (CBI) per 40 CFR Part 2, Subpart B.
This information can be found in the confidential record.


[Federal Register Volume 80, Number 245 (Tuesday, December 22, 2015)]
[Notices]
[Pages 79644-79645]
[FR Doc No: 2015-32053]

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

SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE., Washington, DC
20549-2736.

Extension: Rule 17a-25,
    SEC File No. 270-482, OMB Control No. 3235-0540.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et. seq.) (``PRA''), the Securities and
Exchange Commission (``Commission'') is soliciting comments on the
existing collection of information provided for in Rule 17a-25 (17 CFR
204.17a-25) under the Securities Exchange Act of 1934 (15 U.S.C. 78a
et. seq.).
    Paragraph (a)(1) of Rule 17a-25 requires registered broker-dealers
to electronically submit securities transaction information, including
identifiers for prime brokerage

arrangements, average price accounts, and depository institutions, in a
standardized format when requested by the Commission staff. In
addition, Paragraph (a)(3)(c) of Rule 17a-25 requires broker-dealers to
submit, and keep current, contact person information for electronic
blue sheets (``EBS'') requests. The Commission uses the information for
enforcement inquiries or investigations and trading reconstructions, as
well as for inspections and examinations.
    The Commission estimates that it sends approximately 7,697
electronic blue sheet requests per year to clearing broker-dealers that
in turn submit an average 124,912 responses.\1\ It is estimated that
each broker-dealer that responds electronically will take 8 minutes,
and each broker-dealer that responds manually will take 1\1/2\ hours to
prepare and submit the securities trading data requested by the
Commission. The annual aggregate hour burden for electronic and manual
response firms is estimated to be 8,114 (59,958 x 8 / 60 = 7,994 hours)
+ (80 x 1.5 = 120 hours), respectively.\2\ In addition, the Commission
estimates that it will request 8 broker-dealers to supply the contact
information identified in Rule 17a-25(c) and estimates the total
aggregate burden hours to be 2. Thus, the annual aggregate burden for
all respondents to the collection of information requirements of Rule
17a-25 is estimated at 8,116 hours (7,994 + 120 + 2).
---------------------------------------------------------------------------

    \1\ A single EBS request has a unique number assigned to each
request (e.g. ``0900001''). However, the number of broker-dealer
responses generated from one EBS request can range from one to
several thousand. EBS requests are sent directly to clearing firms,
as the clearing firm is the repository for trading data for
securities transactions information provided by itself and
correspondent firms. Clearing brokers respond for themselves and
other firms they clear for. There were 124,912 responses during the
25 month period for an average of 4,996.5 responses per month or an
average of 59,958 annual responses.
    \2\ Few of respondents submit manual EBS responses. The small
percentage of respondents that submit manual responses do so by
hand, via email, spreadsheet, disk, or other electronic media. Thus,
the number of manual submissions (80) has minimal effect on the
total annual burden hours.
---------------------------------------------------------------------------

    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information shall
have practical utility; (b) the accuracy of the agency's estimate of
the burden of the proposed collection of information; (c) ways to
enhance the quality, utility, and clarity of the information to be
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    Please direct your written comments to: Pamela Dyson, Director/
Chief Information Office, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549 or send an email
to<EMAIL_ADDRESS>
    Dated: December 16, 2015.
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-32053 Filed 12-21-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 32 (Tuesday, February 18, 2014)]
[Notices]
[Pages 9302-9303]
[FR Doc No: 2014-03376]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-71520; File No. SR-Phlx-2014-09]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change to Amend the
Exchange's Pricing Schedule under Section VIII with Respect to
Execution and Routing of Orders in Securities Priced at $1 or More Per
Share

February 11, 2014.
    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 January 31, 2014, NASDAQ OMX PHLX LLC (``Phlx'' or ``Exchange'')
filed with the Securities and Exchange Commission (``SEC'' or
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange proposes to amend the Exchange's Pricing Schedule
under Section VIII, entitled ``NASDAQ OMX PSX FEES,'' with respect to
execution and routing of orders in securities priced at $1 or more per
share.
    While the changes proposed herein are effective upon filing, the
Exchange has designated that the amendments be operative on February 3,
2014.
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaqomxphlx.cchwallstreet.com/, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

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 Exchange 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 Exchange 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 purpose of the proposed rule change is to amend the [sic]
certain fees and credits for order execution and routing applicable to
the use of the order execution and routing services of the NASDAQ OMX
PSX System by member organizations for all securities traded at $1 or
more per share. Specifically, the Exchange is proposing to amend fees
and credits provided for the routing of orders in all securities.
    Currently, for PSTG, PSCN, PTFY, PCRT or XCST orders that execute
at NASDAQ OMX BX (``BX'') the Exchange provides a credit of $0.0011 per
share to the member organization. The Exchange proposes to no longer
offer this credit.
    Additionally, the Exchange currently charges a member organization
entering a PMOP order that executes at the New York Stock Exchange
(``NYSE'') $0.0030 per share. The Exchange is proposing to increase the
charge assessed for such orders executed at NYSE to $0.0035 per share.
    The Exchange also currently charges a member organization $0.0005
per share for entering a PTFY order that executes in a venue other than
the NASDAQ OMX PSX (``PSX), NYSE, The Nasdaq Stock Market LLC
(``Nasdaq'') or BX. The Exchange is proposing to increase the charge
assessed for such orders to $0.0007 per share.
    Finally, the Exchange will institute a $0.0007 per share charge for
XCST and XDRK orders for shares executed at a venue other than BX.
Currently, there is no charge for either XCST or XDRK.
2. Statutory Basis
    The Exchange believes that its proposal to amend its Pricing
Schedule is consistent with Section 6(b) of the Act \3\ in general, and
furthers the objectives of Section 6(b)(4) and (b)(5) of the Act \4\ in
particular, in that it provides for the equitable allocation of
reasonable dues, fees and other charges among members and other persons
using its facilities, and is not designed to permit unfair
discrimination between customers, issuers, brokers, or dealers. The
proposed changes are reasonable because they reflect a modest decrease
in the credits provided in the execution of certain orders and a modest
increase in the fees assessed for others, which will allow the Exchange
to reduce costs and increase revenue.
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    \3\ 15 U.S.C. 78f(b).
    \4\ 15 U.S.C. 78f(b)(4), (5).
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    The Exchange is proposing modest increase of only $0.0002 per
share, from $0.000t [sic] to $0.0007 per share, for a member
organization entering a PTFY order that executes in a venue other than
the PSX, NYSE, NASDAQ or BX. The Exchange proposes the same $0.0007 per
share charge for a member organization entering a XCST or XDRK order
that executes in a venue other than the PSX, NYSE, NASDAQ or BX.
Currently, there is no charge for such XCST and XDRK orders. These
changes are consistent with an equitable allocation of fees and not
unfairly discriminatory because it [sic] will eliminate an existing
disparity between the fees charged for a PTFY, XCST and XDRK orders
that execute in a venue other than the PSX, NYSE, NASDAQ or BX, thereby
making the applicable fees consistent. In addition, the change is
equitable and not unfairly discriminatory because it affects these
similarly situated member organizations in the same way.
    The Exchange is proposing a similarly modest increase of only
$0.0005 per share, from $0.0030 to $0.0035 per share, for a member
organization entering a PMOP order that executes in [sic] the NYSE.
This change is consistent with an equitable allocation of fees and not
unfairly discriminatory because it will eliminate an existing disparity
between the fees charged for a PTFY order executed at NYSE with PMOP
orders executed at venues other than NYSE, thereby making the
applicable fees consistent. In addition,

the change is equitable and not unfairly discriminatory because it
affects all similarly situated member organizations in the same way.
    The Exchange is also proposing to no longer provide a credit of
$0.0011 per share executed at BX to a member organization entering
PSTG, PSCN, PTFY, PCRT or XCST orders that execute at BX. These changes
are reasonable because the Exchange believes it is no longer necessary
to further incentivizes [sic] member organizations to provide displayed
quotes and orders on PSX. Additionally, the changes are equitable and
not unfairly discriminatory because they affect all similarly situated
member organizations in the same way.
    The changes with respect to the charges assessed and credits
provided for routing of orders in all securities are reasonable because
they represent a modest increases [sic] in charges assessed a member
organization for PTFY, XCST and XDRK orders that execute at a venue
other than BX and for PMOP orders that execute at NYSE, and a modest
decreases [sic] in the credits provided to member organizations for
PSTG, PSCN, PTFY, PCRT and XCST orders that execute at BX. The Exchange
notes that the increase in fees and decrease in credits are designed to
incentivize member organizations to provide orders and quotes that
execute on PSX. In addition, the change is equitable and not unfairly
discriminatory because it affects only those members that opt to use
the Exchange's optional routing services.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act, as amended.\5\ The Exchange
notes that it operates in a highly competitive market in which market
participants can readily favor competing venues if they deem fee levels
at a particular venue to be excessive, or rebate opportunities
available at other venues to be more favorable. In such an environment,
the Exchange must continually adjust its fees to remain competitive
with other exchanges and with alternative trading systems that have
been exempted from compliance with the statutory standards applicable
to exchanges. Because competitors are free to modify their own fees in
response, and because market participants may readily adjust their
order routing practices, the Exchange believes that the degree to which
fee changes in this market may impose any burden on competition is
extremely limited. In this instance, the decreased credits and
increased fees are intended to reduce the Exchange's costs, while still
continuing to provide an incentive for members to execute shares on PSX
and make use of its optional routing functionality. Because there are
numerous competitive alternatives to PSX, it is likely the Exchange
will lose market share as a result of the changes if they are
unattractive to market participants. Accordingly, the Exchange does not
believe the proposed changes will impair the ability of members or
competing order execution venues to maintain their competitive standing
in the financial markets.
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    \5\ 15 U.S.C. 78f(b)(8).
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C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received from Members, Participants, or Others

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\6\ At any time within 60 days of the filing
of the proposed rule change, the Commission summarily may temporarily
suspend such rule change if it appears to the Commission that such
action is necessary or appropriate in the public interest, for the
protection of investors, or otherwise in furtherance of the purposes of
the Act. If the Commission takes such action, the Commission shall
institute proceedings to determine whether the proposed rule should be
approved or disapproved.
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    \6\ 15 U.S.C. 78s(b)(3)(A)(ii).
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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-Phlx-2014-09 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.
    All submissions should refer to File Number SR-Phlx-2014-09. 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 such filing also will
be available for inspection and copying at the principal offices of the
Exchange. 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-
Phlx-2014-09, and should be submitted on or before March 11, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
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    \7\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-03376 Filed 2-14-14; 8:45 am]
BILLING CODE 8011-01-P