[Federal Register: November 6, 2009 (Volume 74, Number 214)]
[Notices]
[Page 57542-57544]
[DOCID:fr06no09-108]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-60907; File No. SR-NYSEAmex-2009-73]

Self-Regulatory Organizations; NYSE Amex LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Add Commentary
.04 to Rule 904C

October 30, 2009.

    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') and Rule 19b-4 thereunder,\2\ notice is hereby given
that, on October 19, 2009, NYSE Amex LLC (``NYSE Amex'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and
II, below, which Items have been prepared by the self-regulatory
organization. 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 Exchange proposes to add Commentary .04 to Rule 904C to clarify
position limits on reduced-value index options. The text of the
proposed rule change is attached as Exhibit 5 to the 19b-4 form. A copy
of this filing is available on the Exchange's Web site at http://
www.nyse.com, at the Exchange's principal office 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 self-regulatory organization
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 those 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 parts of such statements.

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

1. Purpose
    The Exchange proposes to define and clarify the treatment of
positions in reduced-value index options. NYSE Amex Rule 904C describes
Position Limits for both Broad Stock Index Groups and Stock Index
Industry Groups. Rule 904C does not describe aggregation requirements
for reduced-value index options, nor does it describe the relationship
of a position in a reduced-value index option to a position in a full-
value index option.
    Occasionally, when an index level is high it becomes less desirable
for trading options because of the large amount of capital involved in
maintaining margin. Additionally, because of the linear nature of
options premiums, the premium for an at-the-money call on an index
level of 500 will be ten times the premium for an at-the-money call at
an index level of 50, and thus more expensive to trade. To

address this situation, the Exchange may list options on a reduced-
value index, in which the full index value is divided by a set amount,
and the new, reduced-value index becomes the underlyer for a class of
options.
    NYSE Amex is proposing to add Commentary .04 to Rule 904C to
require positions in reduced-value index options to be aggregated with
any positions in options on the full-value of the same index.
Additionally, Commentary .04 will explicitly state that the positions
in reduced-value index options will be treated in the same ratio to a
full-value index option position as the ratio between the reduced value
index and the full value index. The Commentary is based on similar rule
provisions of the Chicago Board Options Exchange, Inc. (``CBOE''),
NASDAQ OMX PHLX (``PHLX''), and NYSE Arca, Inc.\3\
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    \3\ See CBOE Rule 24.4(d) and 24.4A(c); PHLX Rule 1001A (e); and
NYSE Arca Rule 5.15(c).
---------------------------------------------------------------------------

    As an example, suppose that the Exchange listed options on the XXX
narrow based index, and that the index had a position limit determined
by Rule 904C of 31,500 contracts. If the Exchange then listed options
on a one-fifth reduced-value of XXX, and designated it as XXR, then the
position of one contract in XXR would be treated as the equivalent to
one-fifth of a contract in XXX. The resultant position limit for XXR
would be 157,500 contracts (5 x 31,500).
    Positions in XXX and XXR would be aggregated such that the
combination of XXX contracts and one-fifth of XXR contracts could not
exceed 31,500.
    The Exchange believes that definition and clarification of the
requirements for the treatment of positions in reduced value index
options will reduce confusion regarding the application of the Rules
and ensure compliance with position limit requirements.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
Section 6(b) \4\ of the Securities Exchange Act of 1934 (the ``Act''),
in general, and furthers the objectives of Section 6(b)(5) \5\ in
particular in that it is designed to promote just and equitable
principles if trade, to prevent fraudulent and manipulative acts, to
remove impediments to and to perfect the mechanism for a free and open
market and a national market system and, in general, to protect
investors and the public interest, by requiring positions in reduced-
value index options to be aggregated with any positions in full-value
index options, and to clarify how contracts in reduced-value index
options are counted.
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    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(5).
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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 that is not necessary or appropriate
in furtherance of the purposes of the Act.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Because the foregoing rule change does not: (1) Significantly
affect the protection of investors or the public interest; (2) impose
any significant burden on competition; and (3) become operative for 30
days after the date of this filing, or such shorter time as the
Commission may designate, it has become effective pursuant to Section
19(b)(3)(A) of the Act \6\ and Rule 19b-4(f)(6) thereunder.\7\
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    \6\ 15 U.S.C. 78s(b)(3)(A).
    \7\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under 19b-4(f)(6) normally may not
become operative prior to 30 days after the date of filing.\8\ However,
Rule 19b-4(f)(6)(iii) \9\ permits the Commission to designate a shorter
time if such action is consistent with the protection of investors and
the public interest. The Exchange has requested that the Commission
waive the 30-day operative delay. The Exchange notes that the proposal
is substantially similar to the rules of other options exchanges \10\
and serves to treat NYSE Amex users with positions in reduced-value
index options in the same manner as they would be treated on the other
options exchanges. In addition, the Exchange notes that waiving the 30-
day operative delay will allow it to immediately offer market
participants options in reduced value index products on the same basis
as they are offered on other exchanges. Based on the foregoing, the
Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest and
hereby designates the proposal as operative upon filing with the
Commission.\11\
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    \8\ 17 CFR 240.19b-4(f)(6)(iii). In addition, Rule 19b-
4(f)(6)(iii) requires that a self-regulatory organization submit to
the Commission written notice of its intent to file the proposed
rule change, along with a brief description and text of the proposed
rule change, at least five business days prior to the date of filing
of the proposed rule change, or such shorter time as designated by
the Commission. The Exchange has satisfied this requirement.
    \9\ Id.
    \10\ See supra note 3.
    \11\ For the purposes only of waiving the 30-day operative
delay, the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors or otherwise in
furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSEAmex-2009-73 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-NYSEAmex-2009-73.
This file number should be included on the subject line if e-mail is
used. To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be

available for inspection and copying in the Commission's Public
Reference Room on official business days between the hours of 10 a.m.
and 3 p.m. Copies of such filing also will be available for inspection
and copying at the principal office of the 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-NYSEAmex-2009-73 and should
be submitted on or before November 27, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
Florence E. Harmon,
Deputy Secretary.
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    \12\ 17 CFR 200.30-3(a)(12).
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[FR Doc. E9-26749 Filed 11-5-09; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 228 (Wednesday, November 29, 2017)]
[Notices]
[Page 56594]
[FR Doc No: 2017-25726]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Electric Quarterly Report Users Group Meeting

------------------------------------------------------------------------
                                                   Docket Nos.
------------------------------------------------------------------------
Electric Quarterly Report User Group     AD18-4-000
 Meeting.
Filing Requirements for Electric         RM01-8-000
 Utility Service Agreements.
Electricity Market Transparency          RM10-12-000
 Provisions of Section 220 of the
 Federal Power Act.
Revisions to Electric Quarterly Report   RM12-3-000
 Filing Process.
Electric Quarterly Reports.............  ER02-2001-000
------------------------------------------------------------------------

    On October 17, 2017, the Federal Energy Regulatory Commission
(Commission) issued a notice that Commission staff will hold an
Electric Quarterly Report (EQR) Users Group meeting on December 5,
2017. The meeting will take place from 1:00 p.m. to 5:00 p.m. (EST) in
the Commission Meeting Room at 888 First Street NE., Washington, DC
20426. All interested persons are invited to attend. For those unable
to attend in person, access to the meeting will be available via
webcast.
    Staff is hereby supplementing the October 17, 2017, notice with the
agenda for discussion. During the meeting, Commission staff and the EQR
users will discuss potential improvements to the EQR program and EQR
filing process, including: (1) Progress since the last user group
meeting; (2) EQR resources and Web site updates; (3) EQR validations
and error messages; and (4) use of ``Other'' as a Product Name and
Product Type Name. Please note that matters pending before the
Commission and subject to ex parte limitations cannot be discussed at
this meeting. An agenda of the meeting is attached.
    Those interested in participating in the discussion are encouraged
to attend in person. All interested persons (whether attending in
person or via webcast) are asked to register online at http://www.ferc.gov/whats-new/registration/12-05-17-form.asp. There is no
registration fee. Anyone with Internet access can listen to the meeting
by navigating to https://www.ferc.gov/EventCalendar/EventsList.aspx?View=listview for FERC Calendar of Events, locating the
EQR Users Group Meeting on the Calendar, and clicking on the link to
the webcast.
    The webcast will allow persons to view and listen to the meeting.
Questions during the meeting can be sent to [email protected].
    Commission conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations, please
send an email to [email protected] or call toll free 1-866-208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a FAX to<PHONE_NUMBER> with
the required accommodations.
    To increase administrative efficiency, issuances related to future
EQR user group meetings will not be assigned to Docket Nos. RM01-8-000,
RM10-12-000, RM12-3-000 and ER02-2001-000. For more information about
the EQR Users Group meeting, please contact Jeff Sanders of the
Commission's Office of Enforcement at<PHONE_NUMBER>, or send an email
to [email protected].

    Dated: November 21, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-25726 Filed 11-28-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 136 (Wednesday, July 15, 2020)]
[Notices]
[Pages 42858-42860]
[FR Doc No: 2020-15263]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-2223]

Clinical Investigations for Prostate Tissue Ablation Devices;
Guidance for Industry and Food and Drug Administration Staff;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the availability of a final guidance entitled ``Clinical
Investigations for Prostate Tissue Ablation Devices.'' This guidance
provides recommendations for clinical investigations for high intensity
ultrasound systems for prostate tissue ablation and new types of
prostatic tissue ablation devices.

DATES: The announcement of the guidance is published in the Federal
Register on July 15, 2020.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-2223 for ``Clinical Investigations for Prostate Tissue
Ablation Devices.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9

a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Clinical Investigations for Prostate Tissue Ablation Devices'' to the
Office of Policy, Guidance and Policy Development, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your request.

FOR FURTHER INFORMATION CONTACT: John Baxley, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2626, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance provides draft recommendations for: (1) Complying
with the clinical testing special control under 21 CFR 876.4340(b)(8)
for premarket notifications (510(k)s) for high intensity ultrasound
systems for prostate tissue ablation and (2) collecting clinical data
to support marketing submissions for new types of prostatic tissue
ablation devices. High intensity ultrasound systems for prostate tissue
ablation transmit high intensity therapeutic ultrasound energy into the
prostate to thermally ablate a defined, targeted volume of tissue.
Other prostate ablation devices achieve the same clinical effect of
ablating targeted tissue volumes using different sources of energy.
    The scope of this guidance is limited to the clinical
investigations of prostate tissue ablation systems to support marketing
authorization for a general indication for ablation of prostatic
tissue. This guidance does not address the clinical investigations of
devices that are intended to treat specific prostatic diseases (e.g.,
prostate cancer or benign prostatic hyperplasia). Additionally, this
document does not address recommendations for non-clinical testing of
prostate tissue ablation systems.
    A notice of availability for the draft guidance appeared in the
Federal Register of June 26, 2019 (84 FR 30125). FDA considered
comments received and revised the guidance as appropriate in response
to the comments, including minor edits to clarify and better explain
FDA's recommendations for the clinical study design. This guidance is
being issued consistent with FDA's good guidance practices regulation
(21 CFR 10.115). The guidance represents the current thinking of FDA on
clinical investigations for prostate tissue ablation devices. It does
not establish any rights for any person and is not binding on FDA or
the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov. Persons unable to download an
electronic copy of ``Clinical Investigations for Prostate Tissue
Ablation Devices'' may send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document.
Please use the document number 16011 to identify the guidance you are
requesting.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3521). The collections of information in
the following FDA regulations and guidance have been approved by OMB as
listed in the following table:

------------------------------------------------------------------------
                                                            OMB control
      21 CFR part or guidance               Topic               No.
------------------------------------------------------------------------
807, subpart E....................  Premarket                  0910-0120
                                     notification.
812...............................  Investigational            0910-0078
                                     Device Exemption.
``De Novo Classification Process    De Novo                    0910-0844
 (Evaluation of Automatic Class      classification
 III Designation)''.                 process.
``Requests for Feedback and         Q-submissions.......       0910-0756
 Meetings for Medical Device
 Submissions: The Q-Submission
 Program''.
50, 56............................  Protection of Human        0910-0755
                                     Subjects: Informed
                                     Consent;
                                     Institutional
                                     Review Boards.
56................................  Institutional Review       0910-0130
                                     Boards.
------------------------------------------------------------------------

    Dated: July 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15263 Filed 7-14-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 243 (Tuesday, December 18, 2012)]
[Notices]
[Pages 74838-74839]
[FR Doc No: 2012-30396]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP13-23-000]

Perryville Gas Storage LLC; Notice of Amendment

    Take notice that on December 3, 2012, Perryville Gas Storage LLC
(Perryville), Three Riverway, Suite 1350, Houston, Texas 77056, filed
in the above referenced docket an application under section 7(c) of the
Natural Gas Act (NGA) and Part 157 of the Commission's regulations for
an order amending the certificate of public convenience and necessity
issued in Docket No. CP09-418-000, and amended in Docket Nos. CP11-159-
000 and CP12-460-000, to authorize Perryville to make certain changes
to its certificated project. Perryville proposes to move the surface
location of one of the approved storage cavern wells (Cavern Well PGS-
2) approximately 400 feet, all as more fully set forth in the
application which is on file with the Commission and open to public
inspection. The filing may also be viewed on the Web at http://www.ferc.gov using the ``eLibrary'' link. Enter the docket number
excluding the last three digits in the docket number field to access
the document. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or TTY,
contact<PHONE_NUMBER>.
    Any questions concerning this application may be directed to J.
Gordon

Pennington, Attorney at Law, 1101 30th Street NW., Suite 500,
Washington, DC 20007, at<PHONE_NUMBER>, or by email at
<EMAIL_ADDRESS>    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit seven copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 14 copies of the protest or intervention to the
Federal Energy regulatory Commission, 888 First Street NE., Washington,
DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is 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 email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on January 2, 2013.

    Dated: December 11, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-30396 Filed 12-17-12; 8:45 am]
BILLING CODE 6717-01-P


  SEQ CHAPTER \h \r 1 MEMORANDUM

DATE:	October 28, 2008

SUBJECT:	Model Plants for Paint and Allied Products Manufacturing Area
Sources

  SEQ CHAPTER \h \r 1

FROM:	Bradley Nelson, EC/R Inc.

TO:		Melissa Payne, EPA/OAQPS/RDPAG   SEQ CHAPTER \h \r 1

1.0	INTRODUCTION

This memorandum presents the model plants used in the development of
National Emission Standards for Hazardous Air Pollutants (NESHAP) for
the Paint and Allied Products Manufacturing area source category.  The
first section of this memorandum contains a brief background of the
Urban Air Toxics Area Source Program and the listing of the Paint and
Allied Products Manufacturing category.  The following sections discuss
the need for model plants for this source category, and the
characteristics and parameters used to develop the model plants.

2.0	BACKGROUND

Section 112(k) requires the development of standards for area sources
that account for 90% of the emissions of the 30 HAPs listed for urban
areas, as prescribed by the Integrated Urban Air Toxics Strategy (UATS).
 The Paint and Allied Products Manufacturing area source category was
added to the listed categories pursuant to section 112(c)(3) and
112(k)(3)(B)(ii) in November 2002 (67 FR 70427).  The UATS listed the
Paint and Allied Products Manufacturing category as one of the area
sources that accounts for a proportion of the 90% emissions for 6 of the
targeted 30 area source air toxic pollutants: benzene, cadmium,
chromium, lead, methylene chloride, and nickel.  The goals of the UATS
reflect both the statutory requirements stated in Section 112(k) and the
goals of EPA’s overall air toxics program.

3.0  	NEED FOR MODEL PLANTS

The paint and allied products manufacturing industry comprises of
establishments primarily engaged in the production of paints, inks,
adhesives, stains, varnishes, shellacs, putties, sealers, caulks, and
other coatings which leave a dried film of solid material on a
substrate.  The industry covers several North American Industry
Classification System (NAICS) codes.  These sectors include NAICS codes
325510 (Paint and Coating Manufacturing), 325520 (Adhesive
Manufacturing), 325910 (Printing Ink Manufacturing), and 325998 (All
Other Miscellaneous Chemical Product and Preparation Manufacturing -
Writing and Stamp Ink Manufacturing).  These sectors use similar
processes and raw materials to produce these products, although the size
and production capacity varies from facility to facility.  The 2002
NAICS inventory estimates just over 2,500 facilities nationwide, with
the majority of these facilities producing paints.  The large number of
facilities and the lack of facility-specific information resulted in the
need to develop model plants to represent the source category.  These
model plants will be used to develop facility emissions, which in turn
will be used to assess control options and regulatory alternatives
considered by EPA.

4.0	CHARACTERISTICS OF MODEL PLANTS

	The main characteristics used to define model plants for the Paint and
Allied Products Manufacturing source category include the production
capacity, number of process vessels, and the HAP emissions from the
facility.  The 2002 economic census for each of the sectors was used to
determine production capacity.  Information from the state permits was
used to estimate the number of process vessels at each facility, and
AP-42 emissions factors and data from the 2002 NEI database were used to
estimate HAP emissions from the facilities.  A discussion of the methods
and the specific data used to develop these model plants is presented in
the following sections.

4.1	Industry Census Data

	The inventory for the paint and allied products manufacturing industry
was obtained from the 2002 economic census for each of the NAICS
industries.  The census lists an inventory of 2,510 paint and allied
product manufacturing facilities.  Table 1 provides a breakdown of the
number of facilities, number of employees, and total value of shipments
for the paint and allied products manufacturing data from the 2002 U.S.
Economic Census.  As the table shows, 62.6% of the paint and allied
products manufacturing facilities have less than 20 employees, but these
facilities only contributed 10.4% of the total sales.  These small
facilities are typically regional paint companies that supply local
hardware stores or home repair centers, or provide specialty coatings to
local industries.  A graphical summary of the combined economic census
data is provided in Figure 1.  As the economic census data show, the
slope of the total value of shipments increases after the 10 to 19
employee range.  At this point the total value of shipments per employee
increases from approximately $300,000 per employee to $400,000 per
employee.

	This value of shipments per employee appears to be a natural division
which can be used to separate the facilities into two groups; facilities
with 19 employees or less, and facilities with 20 employees or greater
for the purpose of developing model plants.  Therefore, we designated
facilities with 19 employees or less as small model plants, and
facilities with 20 employees or more as large model plants.  Therefore,
the census data for 1 to 19 employees was used to represent small model
plants, and would account for 1,572 of the manufacturing facilities,
which are all assumed to be area sources.  For the large model plants,
we believe the value of shipments and production capacity of the 20 to
99 employee’s census data is more representative of area sources in
the large model plant category.  Therefore, the large model plants would
account for the other 618 area source facilities, and are assumed to
have 20 or more employees.  These small and large model plant groups
will be used to represent the area sources for the paint and allied
products manufacturing source category.  Since this rule covers only
area sources, there will be no model plant for the 320 major sources.

Table 1.  Summary of 2002 U.S. Census Data from Paint and Allied
Products Manufacturing Facilities1

Employment Size	Total Number of Facilities	Number of Employees	Total
Value of Shipments ($1,000)	Value of Shipments per Employee ($/employee)

1 to 4 employees	738	1,627	466,806	286,912

5 to 9 employees	387	2,650	929,154	350,624

10 to 19 employees	447	6,249	1,791,827	286,738

20 to 49 employees	522	16,526	5,281,405	319,582

50 to 99 employees	229	15,750	6,203,445	393,870

100 to 249 employees	157	24,164	10,675,531	441,795

250 to 499 employees	26	8,365	3,848,185	460,034

500 to 999 employees	3	2,250	1,134,083	504,037

1,000 to 2,499 employees	1	1,161	381,459	328,561

Total	2,510	78,702	30,701,138	390,093

1 to 19 employees	1,572	10,526	3,187,787	302,849

20 to 2,499 employees	938	68,216	27,524,108	403,484

1 Data Source: 2002 Economic Census for Paint and Coating Manufacturing,
Adhesive Manufacturing, Printing Ink Manufacturing, and All Other
Miscellaneous Chemical and Preparation Manufacturing.

Figure 1.  Graphical Representation of Economic Census Data

for the Paint and Allied Products Manufacturing Industry1

1 Data Source: 2002 Economic Census for Paint and Coating Manufacturing,
Adhesive Manufacturing, Printing Ink Manufacturing, and All Other
Miscellaneous Chemical and Preparation Manufacturing.

4.2	Production Capacity

	Data from the 2002 economic census for each of the NAICS sectors was
used to estimate the production capacity.  The economic census provides
information on the number of facilities, number of employees, and the
total value of shipments from the facility.  To determine the quantity
of paint produced by each facility, data from the Current Industrial
Report for the paint and allied products manufacturing category was
used.  The industrial report provides total quantity and total value of
shipments of paint and allied products.  The report states the total
quantity of paint and allied products produced in 2002 was 1,433,900,000
gallons at a total value of $17,465,800,000.  To estimate the total
value per gallon of paint, the total value was divided by the total
number of gallons.  This calculates to $12.18 per gallon of paint and
allied products produced.  Using this factor and the total value of
shipments listed in the U.S. Census, we can estimate the annual
production for each of the facility employee size categories using the
following equation;

Estimated Annual Production = [Value of Shipments $/year]/[$12.18/gal of
product]

	Where:

	Value of Shipments is the total value of shipments listed in the U.S.
Census for each of 	the employee size categories, and;

	$12.18 is the estimated value of the paint and allied products
calculated using data from 	the Current Industrial Report produced by
the U.S Census Bureau.

The following table provides a summary of the total value and estimated
production of paint and allied products.

Table 2.  Summary of 2002 U.S. Census Data and Estimated Production from
Paint and Allied Products Manufacturing Facilities1

Employment Size	Total Number of Facilities	Total Value of Shipments
($1,000)	Total Estimated Production (gal/yr)	Estimated Production Per
Facility (gal/yr)

1 to 4 employees	738	466,806	38,323,645	51,929

5 to 9 employees	387	929,154	76,281,299	197,109

10 to 19 employees	447	1,791,827	147,104,669	329,093

20 to 49 employees	522	5,281,405	433,590,596	830,633

50 to 99 employees	96	2,600,571	213,511,576	2,224,079

Small Model Plant

(1 to 19 employees)	1,572	3,187,787	261,709,613	166,482

Large Model Plant

(20  or more employees)	618	7,881,976	647,102,172	1,047,090

1 Data Source: 2002 Economic Census for Paint and Coating Manufacturing,
Adhesive Manufacturing, Printing Ink Manufacturing, and All Other
Miscellaneous Chemical and Preparation Manufacturing.

	Of the two model plants categories, the small model plant, with 19
employees or less, is the most common paint and allied products
manufacturing facility.  The small model plant is estimated to produce
almost 167,000 gallons of paint and allied products per year.  The large
model plants are facilities with 20 or more employees and are estimated
to produce about 1,050,000 gallons of coatings per year.  Facilities
with 100 or more employees are assumed to be major sources and are not
modeled in this memorandum.

4.3	HAP Emissions

	Emissions from the model plants were calculated using the small and
large model plant production estimate and AP-42 emissions factors.  The
AP-42 emission factors only provide emission estimates for volatile
organic compounds (VOC) and particulate matter (PM); therefore data from
the NEI database were used to develop factors to estimate the fraction
of VOC and PM that is HAP.  The AP-42 emission factor for VOC is listed
as 1.5 lbs/100 lbs of product.  A density of 12.5 lbs/gal of product was
used to convert the estimated volume production of the model plants to a
weight based production.  The calculated weight based production was
multiplied by the emission factor to determine the VOC emissions from
the model plant.  For the small model plant, the VOC emissions were
calculated to be 15.7 Tons/yr, and the VOC emissions for the large model
plant were calculated to be 98.4 Tons/yr.  A summary of the VOC
emissions is presented in Table 2.

	The fraction of HAP in the VOC emissions was calculated using the 2002
NEI data for sources that provided both VOC and HAP data.  The average
fraction of HAP in the VOC total was calculated to be 0.0989.  A summary
of the VOC and HAP emissions rates is presented in Table 3.  The HAP
emission totals from the 2002 NEI data were used to calculate the
fraction of HAP that is volatile and the fraction of HAP that is
particulate.  The fraction of volatile HAP in the total HAP was
calculated to be 0.9976, and the fraction of total HAP that is
particulate HAP was calculated to be 0.0024.  These fractions were used
to estimate the total, volatile, and particulate HAP emissions from the
model plants.  A summary of these HAP emissions are presented in Table
3.

	PM emissions were calculated using the model plant production data and
the AP-42 emissions factor for PM.  The AP-42 emission factor for PM is
listed as 20 lb/ton of pigment used.  To estimate the amount of pigment
used by the model plant, we looked at the densities of the raw materials
and the product to calculate the amount of pigment in the coating
product.  Using a coating density of 12.5 lb/gal (average density of
produced coating), a density of 33.4 lb/gal for titanium dioxide (a
common pigment), and a solvent density of 7.2 lb/gal for xylene ( a
common solvent), the fraction of pigment in the product coating was
calculated to be 0.20.   Using this fraction, a pigment density of 33.4
lb/gal, and model plant production, the annual pigment usage for the
small model plant was calculated to be 558 tons/yr, and the pigment
usage for the large model plant was estimated to be 3,507 tons/yr.  An
example of the PM emission calculation for the small model plants is as
follows;

Small Model Plant PM Emissions = [167,000 gal/yr]*[0.20]*[33.4
lb/gal]*[Ton/2000 lb]

*[20 lb/Ton of pigment]*[Ton/2000 lb]

Where:

167,000 gal/yr is the estimated production from the small model plant,

0.20 is the fraction of pigment in the paint or allied products,

33.4 lb/gal is the density of the pigment,

Ton/2000 lb is the conversion factor to convert pounds to tons,

20 lb/Ton if pigment is the AP-42 PM emission factor for paint and
allied products, and

Ton/2000 lb is the conversion factor to convert pounds to Tons.

	In addition to HAP, fine particulate matter that is 2.5 micrometers in
diameter and smaller (PM2.5) is also a concern to for both worker and
public health.  Emissions of PM2.5 were estimated using speciation data
provided in the EPA Emissions Modeling Clearinghouse.  Using the Source
Classification Codes (SCC) for paint, varnish, adhesive, and inks
manufacturing, the mass fraction of PM that is PM2.5 were determined for
each of these segments.  For paint and varnish manufacturing, the mass
fraction of PM that is PM2.5 is 0.3995, and for ink and adhesive
manufacturing the mass fraction of PM that is PM2.5 is 0.5624.  To
determine the PM2.5 emissions from the model plants, a facility weighted
average mass fraction was calculated using the total number of area
source facilities and the total number of the area source paint and
varnish and ink and adhesive facilities.  The facility weighted mass
fraction was calculated to be 0.474 and will be used to estimate the
PM2.5 emissions for the model plants.  A summary of the PM2.5 emissions
is shown in Table 3.

Table 3.  Summary of HAP, PM, and VOC Emissions from the

Paint and Allied Products Manufacturing Model Plants

Model Plant	Estimated Plant Production (Gal/yr)	Estimated Pigment Usage
(Tons/yr) 	PM Emissions

(Tons/yr)	PM2.5 Emissions

(Tons/yr)	VOC Emissions (Tons/yr)	HAP Emissions (Tons/yr)	Volatile HAP
Emissions (Tons/yr)	Particulate HAP Emissions (Tons/yr)

Small	167,000	558	5.58	2.64	15.7	1.549	1.545	0.004

Large	1,050,000	3,507	35.1	16.6	98.4	9.733	9.710	0.023

4.4	Process Vessels

For the paint and allied products manufacturing sector, process vessels
are used to combine the raw materials for mixing into the desired
coating.  These process vessels are the main source of HAP emissions
from the paint and allied products manufacturing facilities, which occur
during the addition of the raw materials, mixing of the raw materials
into the final product, and the evaporation of the volatile chemicals.
To determine the number of process vessels used at paint and allied
products manufacturing facilities, we looked at the State permit data.
The permits provided process vessel inventory data for 12 facilities; 5
area sources and 7 major sources.  The process vessels were divided into
two groups, storage vessels and mixing vessels.  Storage vessels are
used to store raw materials for use in the coating production process.
Mixing vessels are used to combine the raw materials into the coating
product.  The size of the process vessels range from 5 to 20,000 gallons
and can be stationary or portable. A summary of the average number of
process vessels per paint and allied products manufacturing facility is
presented in Table 4.

For purposes of estimating the number of process vessels used at the
model plants, we assumed that the small model plant would be similar to
the area source process vessel count described in the State permits.
Therefore, it was assumed that there are 17 process mixing vessels used
at small model plants.  Similarly, we believe that the average number of
process vessels from the major source facilities is comparable to the
number of process vessels at a large model plant.  While these process
vessel counts are from major source facilities, we believe this process
vessel count is representative of the number of process vessels at large
area sources. Therefore, the large model plants are assumed to have 129
process mixing vessels.

5.0	MODEL PLANT SUMMARY

	The model plants described in this memorandum will be used to estimate
facility emissions, develop control options, and calculate the cost of
regulatory alternatives for the Paint and Allied Products Manufacturing
area source sector.  A brief summary of the model plants are described
in the following sections.

5.1	Small Model Plants

	The small model plant developed in this memorandum describes the
majority of area source facilities in the Paint and Allied Products
Manufacturing category.  The small model plant will describe paint and
allied products manufacturing facilities with 19 employees or less.
This small model plant will describe the production of 1,572 of the
2,190 area source facilities.  This plant will be assumed to produce
167,000 gallons of coatings a year, with a pigment usage of 558 tons/yr.
 The small model plant is also assumed to use 17 process mixing vessels
in the production of the coatings.  The HAP emissions from the small
model plant facility are estimated to be 1.549 Tons/yr.

5.2	Large Model Plants

	The large model plant developed in this memorandum describes the
remaining area source facilities in the Paint and Allied Products
Manufacturing category.  The large model plant describes facilities with
20 to 99 employees and comprises of 618 of the 2,190 area source
facilities.  This large model plant will be assumed to produce 1,050,000
gallons of coatings a year, with a pigment usage of 3,507 tons/yr.  The
large model plant is also assumed to use 129 process mixing vessels in
the production of the coatings.  The HAP emissions from the large model
plant facility are estimated to be 9.733 Tons /yr.

Table 4.  Average Number of Process Vessels Used at Paint and Allied
Products Manufacturing Facilities1

Process Vessel Type

Process Vessel Size (gallons)

	50	51 - 100	101 - 200	201 - 500	501 - 1000	1001 - 2500	2501 - 5000	5001
– 10,000	10,001 – 20,000	>20,000	Total

Minor Sources

Storage	0	2	3	4	4	2	3	6	0	1	25

Mixing	1	1	1	2	5	6	1	0	0	0	17

Major Sources

Storage	1	0	1	1	8	14	13	6	6	1	51

Mixing	13	30	14	46	14	10	1	1	0	0	129

1 Data Source: State permits.

2 Average of data from 5 facility permits.

3 Average of data from 7 facility permits.

 The 2002 NAICS codes and industry descriptions were obtained from the
U.S. Census website, http://www.census.gov/epcd/www/naics.html.

 2002 Economic Census, Industry Series, US Department of Commerce, US
Census Bureau. http://www.census.gov/econ/census02/guide/INDRPT31.HTM

 Current Industrial Report, Paints and Allied Products: 2005, US
Department of Commerce, Economics and Statistics Administration, June
2006. http://www.census.gov/industry/1/ma325f05.pdf

 Emissions Modeling Clearinghouse, Speciation,
http://www.epa.gov/ttnchie1/emch/speciation/index.html.

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