[Federal Register Volume 80, Number 220 (Monday, November 16, 2015)]
[Notices]
[Page 70779]
[FR Doc No: 2015-29152]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ID-7757-000]

Drury, Scott D.; Notice of Filing

    Take notice that on November 6, 2015, Scott D. Drury filed an
application for authorization to hold interlocking positions, pursuant
to section 305(b) of the Federal Power Act, 16 U.S.C. 825d(b) and Part
45 of the Regulations of the Federal Energy Regulatory Commission
(Commission), 18 CFR part 45.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). 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. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of 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 5 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 electronic 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 p.m. Eastern Time on November 27, 2015.

    Dated: November 9, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-29152 Filed 11-13-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 127 (Wednesday, July 2, 2014)]
[Notices]
[Pages 37760-37761]
[FR Doc No: 2014-15490]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4173-DR; Docket ID FEMA-2014-0003]

Indiana; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Indiana (FEMA-4173-DR), dated April 22, 2014, and
related determinations.

DATES: Effective Date: May 23, 2014.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Indiana is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of April 22, 2014.

    Blackford, Clinton, Fulton, Hamilton, Johnson, LaGrange, Marion,
Montgomery, and Vanderburgh Counties for Public Assistance.
    Blackford, Clinton, Fulton, Hamilton, Johnson, LaGrange, Marion,
and Montgomery Counties for snow assistance under the Public
Assistance program for any continuous 48-hour period during or
proximate to the incident period.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050 Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2014-15490 Filed 7-1-14; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: September 11, 2006 (Volume 71, Number 175)]
[Notices]
[Page 53439]
[DOCID:fr11se06-66]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 11945-001--Oregon]

Dorena Lake Dam Hydroelectric Project; Notice of Availability of
Draft Environmental Assessment

September 1, 2006.
    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission's (Commission's)
regulations, 18 CFR part 380 (Order No. 486, 52 FR 47897), the Office
of Energy Projects has reviewed Symbiotics, LLC's application for
license for the proposed Dorena Lake Dam Project (or project), located
on the Row River near the city of Cottage Grove, Lane County, Oregon,
and has prepared a Draft Environmental Assessment (Draft EA) for the
project. The proposed project would occupy less than 0.13 acre (5,655
square feet) of federal land administered by the U.S. Army Corps of
Engineers and the U.S. Bureau of Land Management.
    The Draft EA contains the staff's analysis of the potential future
environmental effects of the project, and staff has concluded that
licensing the project, with appropriate environmental protective
measures, would not constitute a major federal action that would
significantly affect the quality of the human environment.
    A copy of the Draft EA is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's Web site
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, contact FERC Online Support at
<EMAIL_ADDRESS>or toll-free at 1-866-208-3676, or for TTY,

202-502-8659.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp
 to be notified via e-mail of new filings and

issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    Any comments (an original and 8 copies) should be filed within 30
days from the date of this notice and should be addressed to Magalie R.
Salas, Secretary, Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426. Please affix ``Dorena Lake Dam
Project No. 11945-001'' to all comments. Comments may be filed
electronically via the Internet in lieu of paper. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
at http://www.ferc.gov under the ``e-filing'' link. The Commission

strongly encourages electronic filings.
    For further information, contact Michael Henry by telephone at 503-
552-2762 or by e-mail at<EMAIL_ADDRESS>
Magalie R. Salas,
Secretary.
[FR Doc. E6-14959 Filed 9-8-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: March 15, 2010 (Volume 75, Number 49)]
[Notices]
[Page 12320-12321]
[DOCID:fr15mr10-98]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61673; File No. SR-OCC-2010-02]

Self-Regulatory Organization; The Options Clearing Corporation;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Relating to Adjustment Increments Applicable to Stock Futures

March 8, 2010.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of
1934,\1\ notice is hereby given that on February 26, 2010, The Options
Clearing Corporation (``OCC'') filed with the Securities and Exchange
Commission the proposed rule change as described in Items I, II, and
III below, which Items have been prepared primarily by OCC. OCC filed
the proposed rule change pursuant to section 19(b)(3)(A)(iii) of the
Act \2\ and Rule 19b-4(f)(4) thereunder \3\ so that the proposal was
effective upon filing with the Commission. 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\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \3\ 17 CFR 240.19b-4(f)(4).
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The proposed rule change will amend the definition of ``adjustment
increment'' applicable to stock futures.

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

    In its filing with the Commission, OCC 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. OCC 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

    The purpose of this rule change is to accommodate a request made by
OneChicago LLC (``ONE'') to refine the adjustment increment when stock
futures are adjusted in response to corporate actions. Currently, the
adjustment increment for stock futures is the minimum increment in
settlement prices, which is one cent ($.01). ONE desires to change the
adjustment increment for stock futures to one hundredth of a cent
($.0001). Daily settlement prices and trade prices would continue to be
expressed in pennies on a per-contract basis. This change would affect
any corporate action for which settlement prices are adjusted,
including cash distributions.\4\
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    \4\ See OCC Article XII, Section 3(a), for a description of the
general rules applicable to adjustments to stock futures.
---------------------------------------------------------------------------

    As an example of the intended change, suppose a futures contract
settlement price needs to be adjusted to reflect a $0.125 per share
cash dividend. If the per-share settlement price is $50.00, the
adjusted settlement price would be $50.00-$0.125 = $49.8750. If the
closing settlement price the following day is $50.05, a mark-to-market
of $50.05-$49.875 = $0.1750, or $17.50 per contract, would result.
Prior to the change, the adjusted settlement price of $49.875 would
have been rounded to $49.88. The resulting next day mark-to-market
would have been $50.05-$49.88 = $0.17, or $17.00 per contract. In that
case, $0.50 in mark-to-market value would not have been accounted for.
    OCC states that the proposed change is consistent with Section 17A
of the Act \5\ because it facilitates the clearance and settlement of
stock futures transactions by providing a more precise calculation of
the impact of certain adjustments. OCC also states that the proposed
rule change is not inconsistent with the existing rules of OCC
including any other rules proposed to be amended.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78q-1.
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B. Self-Regulatory Organization's Statement on Burden on Competition

    OCC does not believe that the proposed rule change would impose any
burden on competition.

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

    OCC has not solicited or received written comments relating to the
proposed rule change. OCC will notify the Commission of any written
comments it receives.

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)(iii) of the Act \6\ and Rule 19b-4(f)(4) \7\ thereunder
because it effects a change in an existing service of a registered
clearing agency that does not adversely affect the safeguarding of
securities or funds in the custody or control of the clearing agency or
for which it is responsible and does not significantly affect the
respective rights or obligations of the clearing agency or persons
using the service. At any time within 60 days of the filing of the
proposed rule change, the Commission may summarily abrogate such rule
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.
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    \6\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \7\ 17 CFR 240.19b-4(f)(4).
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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 e-mail to<EMAIL_ADDRESS>Please include
File No. SR-OCC-2010-02 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, Station Place, 100 F
Street, NE., Washington, DC 20549-1090.

All submissions should refer to File No. SR-OCC-2010-02. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C 552, will be available for inspection and copying
in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at OCC's principal office and on OCC's Web site
at http://www.theocc.com/publications/rules/proposed_changes/
proposed_changes.jspU. 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 submission should refer to File No. SR-
OCC-2010-02 and should be submitted on or before April 5, 2010.

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\8\
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    \8\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-5534 Filed 3-12-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: January 27, 2010 (Volume 75, Number 17)]
[Notices]
[Page 4402-4406]
[DOCID:fr27ja10-98]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0054]

Strengthening the Center for Devices and Radiological Health's
510(k) Review Process; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION:  Notice of public meeting; request for comments.

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    The Food and Drug Administration (FDA) is announcing a public
meeting entitled ``Strengthening the Center for Devices and
Radiological Health's 510(k) Review Process.'' The purpose of the
public meeting is to identify actions that the Center for Devices and
Radiological Health (CDRH) can consider taking to strengthen the
premarket notification process for review of medical devices, also
known as the 510(k) process. FDA is seeking input on a number of
identified challenges associated with the 510(k) process and is
requesting comments on this topic.
    Dates and Time: The public meeting will be held on February 18,
2010, from 8 a.m. to 5:30 p.m. Persons interested in attending and/or
participating in the meeting must register by 5 p.m. on

February 12, 2010. Submit electronic or written comments by March 5,
2010.
    Location: The public meeting will be held at the Hilton Washington
DC North/ Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877. A live
webcast of this meeting will be viewable on the day of the meeting at
http://www.ConnectLive.com/events/fda021810. Closed captioning for this
webcast will be available at http://www.speche.com/
sbload.aspx?Load=Web,All,New&Height=90%25&Width=100%25&ClientID=31213.
    Contact Person: James Swink, Food and Drug Administration, Center
for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg.
66, rm. 1609, Silver Spring, MD 20993,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>    Registration: If you wish to attend the public meeting, you must
register online at http://www.fda.gov/MedicalDevices/NewsEvents/
WorkshopsConferences/default.htm (select the appropriate meeting from
the list). Provide complete contact information for each attendee,
including: Name, title, affiliation, address, e-mail, and telephone
number. Registration requests should be received by February 12, 2010.
    If you wish to make an oral presentation during any of the open
comment sessions at the meeting (see section II of this document), you
must indicate this at the time of registration. FDA has included
general discussion topics and specific questions for comment in section
III of this document. You should also identify which discussion topic
you wish to address in your presentation. In order to keep each open
session focused on the discussion topic at hand, each oral presentation
should address only one discussion topic. FDA will do its best to
accommodate requests to speak. Individuals and organizations with
common interests are urged to consolidate or coordinate their
presentations, and to request time for a joint presentation. FDA will
determine the amount of time allotted to each presenter and the
approximate time that each oral presentation is to begin.
    If you would like to participate in the planned end-of-day round-
table discussion (see section II of this document), you must indicate
this at the time of registration, and also submit a brief statement
that describes your experience with the 510(k) program. FDA is seeking
participants interested in engaging in an end-of-day round-table
discussion reflecting on the presentations given earlier in the day.
The round-table discussion will include no more than 10 non-FDA
participants. Only one participant from an organization or company will
be assigned to the discussion group. FDA will attempt to have a range
of constituencies participate in the discussion group. Others in
attendance at the public meeting will have an opportunity to listen to
the discussion.
    Registration is free and will be on a first-come, first-served
basis. Early registration is recommended because seating is limited.
FDA may limit the number of participants from each organization based
on space limitations. Registrants will receive confirmation once they
have been accepted. Onsite registration on the day of the public
meeting will be provided on a space-available basis beginning at 7 a.m.
    If you need special accommodations due to a disability, please
contact James Swink at<PHONE_NUMBER><EMAIL_ADDRESS>at least 7
days in advance of the public meeting.
    Comments: FDA is holding this public meeting to obtain information
on a number of questions regarding the 510(k) process. The deadline for
submitting comments related to this public meeting is March 5, 2010.
    Regardless of attendance at the public meeting, interested persons
may submit electronic or written comments. Submit electronic comments
to http://www.regulations.gov. Submit a single copy of electronic
comments or two paper copies of any mailed comments, except that
individuals may submit one paper copy. Submit written comments to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Comments are to be
identified with the docket number found in brackets in the heading of
this document. In addition, when responding to specific questions as
outlined below, please identify the question you are addressing.
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

SUPPLEMENTARY INFORMATION:

I. Background

    The premarket notification (or 510(k)) process for the review of
medical devices was established under the Medical Device Amendments of
1976 (MDA) to the Federal Food, Drug, and Cosmetic Act (act). A post-
MDA device may be legally marketed without an approved premarket
approval application (PMA) if FDA concludes, through review of a 510(k)
submission (unless the device is exempt from this submission
requirement), that the device meets the comparative standard of
``substantial equivalence'' to a ``predicate'' device. By regulation,
substantial equivalence may be determined by a comparison to a device
that was legally marketed prior to May 28, 1976 (a pre-amendments
device), or a device which has been reclassified from class III to
class II or I (the predicate), or a device which has been found to be
substantially equivalent through the 510(k) premarket notification
process. (21 CFR 807.92(a)(3)).
    Congress enacted the Safe Medical Devices Act of 1990 (SMDA) to
define ``substantial equivalence'' consistent with the agency's
administration of the 510(k) program. ``Substantial equivalence''
means, with respect to a device being compared to a predicate device,
that the device has the same intended use as the predicate device and
that the FDA by order has found the device either has the same
technological characteristics as the predicate device, or has different
technological characteristics and the information submitted that the
device is substantially equivalent to the predicate device contains
information, including appropriate clinical or scientific data if
deemed necessary by the FDA, that demonstrates that the device is as
safe and effective as a legally marketed device and does not raise
different questions of safety and effectiveness than the predicate
device. (Section 513(i)(1)(A) of the act (21 U.S.C. 360c(i)(1)(A))).
    The current 510(k) program reflects the statutory framework and
FDA's implementation of that framework. It is intended to meet two
important public health goals: To make available to consumers devices
that are safe and effective, and to promote innovation in the medical
device industry. The 510(k) premarket notification process provides a
mechanism for the classification of a device that is found to be
substantially equivalent to a predicate device that does not require
premarket approval. Over the past several years, concerns have been
raised about whether the 510(k) program optimally achieves its intended
goals.
    In light of these concerns, FDA commissioned the Institute of
Medicine (IOM) to conduct an independent review of the program and, if
necessary, to recommend administrative, regulatory, and/or statutory
changes. Given that the IOM study is not expected to conclude until
March 2011, CDRH has also convened an internal 510(k) Working Group to
recommend possible actions that CDRH could take in the short term to
strengthen the program, and to identify longer term

options FDA could consider to strengthen the program.

II. Public Meeting

    The objective of this public meeting is to receive public input on
key challenges related to the 510(k) program, focusing on the following
four areas: (1) Issues related to predicate devices, (2) issues related
to new technologies and scientific evidence, (3) issues related to
practices CDRH has adopted in response to a high volume of
510(k)submissions, and (4) issues related to postmarket surveillance
and new information about marketed devices.
    During the meeting, FDA staff will present a brief overview of each
of the areas of challenge listed previously. Each of the four FDA
presentations will be followed by an open comment session, during which
members of the public may present oral comments related to the topic
under discussion. Specific questions related to each discussion topic
are listed below (see section III of this document). As described
previously, individuals who are interested in making an oral
presentation during any of the open comment sessions must indicate this
at the time of registration and must also identify which discussion
topic they intend to address (see the Registration section of this
document). In order to keep each open session focused on the discussion
topic at hand, each oral presentation should address only one
discussion topic. Commentators are free to submit written comments on
any discussion topic(s) to the open docket (see the Comment section of
this document). FDA will schedule speakers for each open session as
time permits.
    After the four open comment sessions, the meeting will close with a
round-table discussion between FDA staff and selected participants
representing a range of constituencies (for more information about
participating in the round-table discussion, see the Registration
section of this document). The participants in the round-table
discussion will reflect on the day's presentations, engage in a
dialogue with each other and FDA staff, and provide closing thoughts.
The participants will not be asked to develop consensus opinions during
the discussion, but rather to provide their individual perspectives.
Others in attendance at the meeting will have an opportunity to listen
to the round-table discussion.
    In advance of the meeting, additional information, including a
meeting agenda with a speakers' schedule for each open comment session,
will be made available on the Internet. This information will be placed
on file in the public docket (docket number found in brackets in the
heading of this document), which is available at http://
www.regulations.gov. This information will also be available at http://
www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm
(select the appropriate meeting from the list).

III. Issues for Discussion

    The discussion of the four general topics described in the
following section of this document should not be limited by current
statutes or regulations, as the recommendations the 510(k) Working
Group develops may include recommendations for changes to current law.

A. Issues Related to Predicate Devices

    1. FDA maintains a searchable online database to provide interested
parties, including prospective 510(k) submitters, with information
about devices that have been cleared for marketing through the 510(k)
process. Currently, if a device has been cleared, CDRH's Office of
Device Evaluation (ODE) and Office of In-Vitro Diagnostics (OIVD) post
online FDA's ``Substantially Equivalent'' (SE) letter to the 510(k)
submitter with the Indications for Use page for the device, as well as
the 510(k) Summary (written by the 510(k) submitter) or the 510(k)
Statement for the 510(k) (as specified by 21 CFR 807.93) (see 21 CFR
807.87(h)). OIVD also posts a ``decision summary'' (written by FDA
reviewers) which includes a summary of submitted data and a comparison
of the device to the predicate(s). With respect to the information
described previously, please comment on the following:
    a. How effective is the 510(k) database and search engine in
helping prospective submitters find and evaluate the adequacy of
predicate devices for 510(k) submissions, and write substantial
equivalency rationales? What aspects of the database and search engine
are useful? What could be improved? What, if anything, should be added
to the 510(k) database and search engine?
    b. How effectively do the publicly released documents listed
previously describe the cleared indications for use of each device, the
technological characteristics of the device, and the methods and type
of information that were used to determine substantial equivalence to
the device's predicate(s)? If these documents are not sufficient,
please describe what additional information or documentation would be
useful to interested parties.
    c. Should FDA require 510(k) holders who receive a substantial
equivalence decision for their device to submit a redacted version of
their 510(k) submission after clearance, for public release? Please
explain why or why not.
    2. Some 510(k) submitters do not accurately portray the
similarities and differences between the device under review and the
predicate device(s). It is unclear whether this problem is due to the
submitters' lacking complete information about devices that have been
cleared previously and may be used as predicates, or whether there are
other contributing factors. Please comment on this problem and what
steps FDA should take to address it.
    3. Generally, a device that has a clearance under the 510(k)
process may be used as a predicate, regardless of whether or not the
device is still in use, remains relevant to current standards of care,
or has been replaced by new technology. Please comment on the utility
of this generally inclusive strategy and its positive or negative
impact on achieving the two public health goals of the 510(k) program.
Should there be stricter criteria for what predicate devices are
eligible for use in new 510(k) submissions? If so, what criteria should
be used, and how should those criteria be defined so that they can be
consistently and effectively applied? Where possible, please also
provide specific examples of cases in which the use of an ``outdated''
predicate device may have been beneficial or problematic.
    4. Incremental device changes may seem innocuous individually
(i.e., in one 510(k) submission), but over time such changes may
accumulate to create a device that is significantly different from the
original device (referred to as ``predicate creep''). Similarly,
clinical non-inferiority studies may be submitted as evidence of
substantial equivalence between a device under review and a predicate.
When a series of such studies is conducted over time (i.e., device B is
non-inferior to A, device C is non-inferior to B, and device D is non-
inferior to C), the difference in effectiveness between device A and D
may approach clinical significance (referred to as ``non-inferiority
creep''). Please comment on what if any changes should be made to the
510(k) program based on the occurrence of predicate creep and non-
inferiority creep. Are there circumstances under which FDA should
consider a more thorough review of multiple incremental device changes
between 510(k) submissions, or a more thorough review of the
appropriateness of clinical non-inferiority studies when

assessing differences in device safety and effectiveness? Please
explain.
    5. In some cases, more than one predicate device has been submitted
by the 510(k) submitter in its evaluation of substantial equivalence.
For example, if there is not a single predicate device that has the
same indication for use and technological characteristics as the device
under review, a submitter may cite one predicate device in an effort to
demonstrate the same intended use, and a different predicate device in
an effort to demonstrate the same technological characteristics. The
use of more than one predicate in this manner, in an effort to
demonstrate substantial equivalence, has been referred to as using a
``split predicate.'' When a submitter uses a split predicate, the
``new'' device may be very different from any other device on the
market. In other instances, a submitter has used more than one
predicate device in the hope that each predicate individually (not
combined with the other predicate) supports substantial equivalence.
Please comment on whether the use of a split predicate or more than one
predicate serves the public health goals of the 510(k) program. If
possible, please include examples.
    6. To find that a device is substantially equivalent, FDA must
determine, among other things, whether or not a new device has the same
``intended use'' as the predicate device (Section 513(i) of the act).
FDA uses a standardized series of questions, organized into a flowchart
(available at http://www.fda.gov/downloads/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/UCM081395.pdf), to guide
all 510(k) reviews. Currently, the flowchart distinguishes between an
``indication for use'' and an ``intended use'': A device under review
may have a different ``indication for use'' than the predicate, yet
still be determined to have the same ``intended use'' and therefore may
be found substantially equivalent.
    a. Please describe your understanding of an ``indication for use''
as compared to an ``intended use.'' Please describe what criteria, if
any, FDA should use to determine whether or not to consider a different
``indication for use'' to be a different ``intended use.'' Please
provide examples of different ``indications for use'' that you believe
should or should not be considered different ``intended uses'' and
explain your reasoning.
    b. What are the advantages and disadvantages of distinguishing
between the terms ``indication for use'' and ``intended use'' during
the review process? What are the advantages and disadvantages of
combining these concepts into one term?

B. Issues Related to New Technologies and Scientific Evidence

    1. Section 513(i) of the act defines the term ``different
technological characteristics'' as ``a significant change in the
materials, design, energy source, or other features of the device from
those of the predicate device.'' Without regard to the statutory
definition, what ``other features'' should FDA consider (or not
consider) to be ``different technological characteristics''? If you do
not believe any other features should be considered different
technological characteristics, please state why.
    2. When a 510(k) submitter receives a Not Substantially Equivalent
(NSE) determination from FDA, the submitter may petition FDA, if this
type of device has not been approved through the PMA process, to
classify this new type of device through the Evaluation of Automatic
Class III Designation (or de novo) process. FDA may classify such a
device as Class I is if the device type is generally of low risk and
general controls are determined to be adequate to provide reasonable
assurance of safety and effectiveness, or as Class II if special
controls can be developed and are adequate, along with general
controls, to provide reasonable assurance of safety and effectiveness
for the device type. What criteria should FDA use to determine which
risks can be mitigated through general controls alone or with special
controls, and which risks are sufficient to make the device ineligible
for de novo classification?
    3. If a device under review has ``different technological
characteristics'' than the predicate(s), it may still be determined to
be substantially equivalent if ``the information submitted that the
device is substantially equivalent to the predicate contains
information, including appropriate clinical or scientific data if
deemed necessary by the [FDA] * * *, that demonstrates the device is as
safe and effective as a legally marketed device and (II) [the device
under review] does not raise different questions of safety and
effectiveness than the predicate device'' (section 513(i) of the act).
How should FDA identify and characterize the risks associated with a
new technology that do not raise ``different questions of safety and
effectiveness?'' Are there types of new technology that should not be
considered appropriate to be cleared for market through the 510(k)
process? Should FDA define ``different questions of safety and
effectiveness?'' If so, please provide suggestions for such a
definition.
    4. In some circumstances, FDA may consider data from one of the
following four types of comparison studies, or a combination of any of
them, to determine whether a new device is substantially equivalent to
a predicate device: (1) A comparison of specifications to an FDA-
recognized standard; (2) a comparison of specifications through bench
testing; (3) a comparison of specifications through bench and animal or
bench and clinical testing; or (4) a comparison of specifications
through bench, animal, and clinical testing.
    a. For each particular type of comparison, describe when the
comparison is appropriate for a new device.
    b. When clinical testing is deemed necessary, such testing is often
used to determine whether a device is at least as safe and effective as
the predicate (i.e., no worse than the predicate by a small, clinically
insignificant difference called the non-inferiority margin). If the
device is not expected to perform any better than the predicate, then a
large sample size may be necessary to show non-inferiority in
accordance with the small margin. By contrast, clinical studies
conducted to demonstrate superiority to a control, instead of non-
inferiority to a predicate, may require a relatively small sample size.
Considering that devices under the 510(k) program may represent
relatively minor changes compared with a predicate, are there
circumstances under which one could show that a device is at least as
safe and effective as the predicate without the need to conduct a large
non-inferiority study? Please explain.
    c. The previous comparisons in (2), (3), and (4) each require some
type of testing. Under what circumstances should such testing be
performed on the new device alone, and under what circumstances should
such testing be performed on the new device in addition to a predicate
device as a concurrent comparison? Are there circumstances when a
clinical study that does not use the predicate device as the comparator
(e.g., uses a standard of care or a reference method instead) would be
appropriate to evaluate substantial equivalence? Please explain.
    5. Some 510(k) submitters do not always initially provide
sufficient engineering and design information for their devices under
review, to enable FDA to have a sufficient understanding of how the
device operates, and whether there are any design issues that would
prevent it from operating as intended. Has FDA established sufficiently
clear

guidelines concerning the provision of such information in 510(k)
submissions? If not, what additional guidance might be helpful?
    6. Section 513(f)(5) of the act (21 U.S.C. 360c(f)(5)) states that
FDA may not withhold an initial classification determination based on
``a failure to comply with any provision of the act unrelated to a
substantial equivalence decision,'' including current good
manufacturing practice (cGMP) requirements, unless there is a
substantial likelihood that such failure will potentially present a
serious risk to human health. Would it be beneficial for FDA to have
greater authority to withhold an initial classification determination
based on a failure to comply with cGMP requirements or other provisions
of the act? Please explain.
    7. Currently, some 510(k) submissions include as the ``indication
for use'' a device function that is not associated with a specific
clinical utility (e.g., treatment or diagnosis of a specific
condition).
    a. For new devices, should a requirement of the 510(k) program be
that a device's ``indication for use'' be proven to FDA to provide
clinical utility?
    b. Please provide examples of devices whose ``indications for use''
statements do not describe a clinical utility, and whether this may be
beneficial, harmful, or neither. Examples may include devices that are
capable of monitoring or measuring a new physiologic parameter that has
no standard clinical context, or tool-type devices such as scalpels or
lasers that may be cleared to cut and coagulate tissue.
    8. How effective is FDA's current implementation of section
513(i)(1)(E) of the act with respect to curbing off-label use that
could cause harm? The current implementation is described in
``Determination of Intended Use for 510(k) Devices; Guidance for CDRH
Staff (Update to K98-1)'' which is available at http://www.fda.gov/
MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/
ucm082162htm. Without regard to current law, should FDA consider
modifying its approach? Please explain why or why not. If FDA should
consider modifying its approach, how should FDA modify it?

C. Issues Related to Practices CDRH has Adopted in Response to a High
Volume of 510(k) Submissions

    FDA receives a very large number of 510(k) submissions each year.
In response to this high volume of work, CDRH has adopted a number of
practices to allow for less resource-intensive reviews, including the
third party review program, the Special 510(k) under the 510(k)
Paradigm, bundling of devices in 510(k) submissions, and reliance on
510(k) submitters' assertions of conformance to recognized standards
(as in the Abbreviated 510(k) program). Due to resource constraints,
CDRH often must rely on a single reviewer to assess each 510(k)
submission. Please comment on the advantages and disadvantages of each
of these practices, as related to the quality and timeliness of 510(k)
reviews.

D. Issues Related to Postmarket Surveillance and New Information about
Marketed Devices

    1. FDA generally does not require postmarket surveillance studies
as a condition of medical device 510(k) clearance. Without regard to
current law, please comment on whether or not it might be beneficial
for FDA to impose such studies as a condition of medical device 510(k)
clearance.
    2. Without regard to current law, should FDA allow for the
rescission of 510(k) clearance decisions under a broad range of
circumstances? If so, what specific criteria might justify the
rescission of a 510(k) clearance decision?
    3. FDA obtains a significant amount of postmarket information for
510(k)-cleared devices, including adverse event reports, recalls, and
inspectional findings. Without regard to current law, should such
information influence the premarket 510(k) review of similar devices?
If so, how?
    4. FDA regulations require the submission of proposed labeling
(including indications for use, directions for use, precautions,
warnings, and contraindications) in a 510(k) prior to clearance of a
device. However, 510(k) holders sometimes alter the labeling after
clearance, so that the final printed labeling is different from that
submitted to FDA in the 510(k). Please comment on whether or not it
might be beneficial for FDA to review and clear the final printed
labeling for all 510(k) devices or for selected 510(k) devices prior to
marketing.
    5. FDA does not always know when there has been a purchase, sale,
or transfer of ownership of a 510(k) for a particular device. Even
though the new owner of the 510(k) is required to register and list,
FDA may not be aware that the ownership of the 510(k) for the device
has legally transferred. Should FDA exercise more authority in this
area? If so, how?

IV. Transcripts

    Transcripts of the public meeting may be requested in writing from
the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857,
approximately 15 working days after the public meeting at a cost of 10
cents per page. A transcript of the public meeting will be available on
the Internet at http://www.regulations.gov.

    Dated: January 22, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-1620 Filed 1-22-10; 4:15 pm]
BILLING CODE 4160-01-S


[Federal Register Volume 83, Number 207 (Thursday, October 25, 2018)]
[Notices]
[Pages 53869-53870]
[FR Doc No: 2018-23362]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-RO7-OW-2018-0678; FRL-9985-46-Region 7]

Notice of Approval of the Primacy Application for National
Primary Drinking Water Regulations for the State of Nebraska

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of approval and solicitation of requests for a public
hearing.

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SUMMARY: The Environmental Protection Agency (EPA) is hereby giving
notice that the State of Nebraska is revising its approved Public Water
System Supervision Program under the Nebraska Department of Health and
Human Services. EPA has determined that these revisions are no less
stringent than the corresponding Federal regulations. Therefore, the
EPA intends to approve these program revisions. Any interested person,
other than Federal Agencies, may request a public hearing. If a
substantial request for a public hearing is made within the requested
thirty-day time frame, a public hearing will be held and a notice will
be given in the Federal Register and a newspaper of general
circulation. Frivolous or insubstantial requests for a hearing may be
denied by the Regional Administrator.

DATES: This determination shall become final and effective on November
26, 2018, unless a timely and appropriate request for a public hearing
is received or the Regional Administrator elects to hold a public
hearing on his own motion. A request for a public hearing must be
submitted to the Regional Administrator at the address shown below by
November 26, 2018. If no timely and appropriate request for a hearing
is received, and the Regional Administrator does not elect to hold a
hearing on his own motion, this determination will become effective on
November 26, 2018.

ADDRESSES: Requests for Public Hearing shall be addressed to: Regional
Administrator, Environmental Protection Agency, Region 7, 11201 Renner
Blvd., Lenexa, Kansas 66219. Requests for a public hearing shall
include the following information: Name, address and telephone number
of the individual, organization or other entity requesting a hearing; a
brief statement of the requesting person's interest in the Regional
Administrator's determination and a brief statement on information that
the requesting person

intends to submit at such hearing; the signature of the individual
making the request or, if the request is made on behalf of an
organization or other entity, the signature of a responsible official
of the organization or other entity.

FOR FURTHER INFORMATION CONTACT: Kenneth L. Deason, Environmental
Protection Agency Region 7, Drinking Water Management Branch, (913)
551-7585, or by email at [email protected].

SUPPLEMENTARY INFORMATION: Notice is hereby given that the EPA has
determined to approve an application by the Nebraska Department of
Health and Human Services to incorporate the following EPA National
Primary Drinking Water Regulations: Revised Total Coliform Rule
(February 13, 2013, 78 FR 10270) and minor corrections (February 26,
2014, 79 FR 10665). This determination to approve the Nebraska program
revision is made pursuant to 40 CFR 142.12(d) (3).
    The application demonstrates that Nebraska has adopted drinking
water regulations which satisfy the National Primary Drinking Water
Regulations. EPA has determined that Nebraska's regulations are no less
stringent than the corresponding Federal regulations and that Nebraska
continues to meet all requirements for primary enforcement
responsibility as specified in 40 CFR 142.10.
    All documents relating to this determination are available for
inspection between the hours of 9:00 a.m. and 3:00 p.m., Monday through
Friday at the following offices: Nebraska Department of Health and
Human Services, Drinking Water Division, 1200 N Street, Suite 400,
Lincoln Nebraska 68509-8922. Environmental Protection Agency, Region 7,
Water Wetlands and Pesticides Division, Drinking Water Management
Branch, 11201 Renner Blvd. Lenexa, Kansas 66219.

(Authority: Section 1413 of the Safe Drinking Water Act, as amended,
and 40 CFR 142.10, 142.12(d) and 142.13)

    Dated: October 19, 2018.
Jim Gulliford,
Regional Administrator, Region 7.
[FR Doc. 2018-23362 Filed 10-24-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: August 10, 2009 (Volume 74, Number 152)]
[Notices]
[Page 39981-39983]
[DOCID:fr10au09-67]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-60416; File No. SR-BX-2009-045]

Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of
Filing and Order Granting Accelerated Approval of Proposed Rule Change
To Amend the Fee Schedule of the Boston Options Exchange Group, LLC

July 31, 2009.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby given
that on July 31, 2009, NASDAQ OMX BX, Inc. (``BX'' or ``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 and grant accelerated
approval of the proposed rule change.
---------------------------------------------------------------------------

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

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

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

    The Exchange is proposing an amendment to the Fee Schedule of the
Boston Options Exchange Group, LLC (``BOX''). The text of the proposed
rule change is available from the principal office of the Exchange, at
the Commission's Public Reference Room and also on the Exchange's
Internet Web site at http://nasdaqomxbx.cchwallstreet.com/NASDAQOMXBX/
Filings/.

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 these statements may be examined at
the places specified in Item III below, and the most significant
aspects of such statements are set forth in Sections A, B, and C below.

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

1. Purpose
    The Exchange recently submitted a proposed rule change \4\ with the
Commission which added the Non-Penny Pilot Class Pricing Structure as
Section 8 of the BOX Fee Schedule.\5\ Executions on BOX in these Non-
Penny Pilot Classes resulting from orders sent via the InterMarket
Linkage System (``Linkage Orders'') are currently subject to
``standard'' billing on BOX.
---------------------------------------------------------------------------

    \4\ See SR-BX-2009-044.
    \5\ The Non-Penny Pilot Class Pricing Structure applies to all
classes listed for trading on BOX that are not included in the Penny
Pilot Program, as referenced in Chapter V, Section 33 of the BOX
Rules (``Non-Penny Pilot Classes'').
---------------------------------------------------------------------------

    In conjunction with the above referenced rule change the Exchange
is now proposing to apply the Non-Penny Pilot Class Pricing Structure
to all Linkage Orders in Non-Penny Pilot Classes sent to and executed
on BOX. If approved, this proposal will conform Linkage Fees with the
fees charged to BOX Participants for transactions in the in [sic] same
Non-Penny Pilot Classes.
    For example, an inbound Linkage Order, whether a P or P/A Order,
routed to BOX from an away market executes against an order resting on
the BOX Book. The inbound Linkage Order is the remover of liquidity.
The inbound Linkage Order will receive a $0.30 credit according to the
Non-Penny Pilot Class pricing structure. The inbound Linkage Order will
ultimately receive a $0.10 credit in total (the $0.30 Non-Penny Pilot
Class Pricing Structure credit less the standard $0.20 inbound Linkage
Order transaction fee). Prior to this proposal the inbound Linkage
Order would be charged $0.20 in total.
    Alternatively, a Public Customer order is entered into the BOX
Trading Host and is routed to an away market as an outbound Linkage
Order. The Public Customer's Linkage Order is the remover of liquidity
from the BOX Book. The Public Customer will ultimately receive a $0.30
total credit according to the Non-Penny Pilot Class pricing structure
as the standard transaction fee for the routing of Linkage Orders by
BOX to away markets is free. Prior to this proposal the Public
Customer's routed order neither received a credit nor was charged a
fee.
2. Statutory Basis
    The Exchange believes that the proposal is consistent with the
requirements of Section 6(b) of the Act,\6\ in general, and Section
6(b)(4) of the Act,\7\ in particular, in that it provides for the
equitable allocation of reasonable dues, fees, and other charges among
its members and issuers and other persons using its facilities. In
particular, the proposed change will allow the fees charged on BOX to
remain competitive with other exchanges.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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.

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

    The Exchange has neither solicited nor received comments on the
proposed rule change.

III. 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-BX-2009-045 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-BX-2009-045. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of the 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-BX-2009-045 and should be
submitted on or before August 31, 2009.

IV. Commission's Findings and Order Granting Accelerated Approval of
the Proposed Rule Change

    After careful consideration, the Commission finds that the proposed
rule change is consistent with the requirements of the Act and the
rules and regulations thereunder applicable to a national securities
exchange.\8\ In

particular, the Commission finds that the proposed rule change is
consistent with Section 6(b)(4) of the Act,\9\ which requires that the
rules of an exchange to provide for the equitable allocation of
reasonable dues, fees and other charges among its members and other
persons using its facilities.
---------------------------------------------------------------------------

    \8\ In approving this rule change, the Commission notes that it
has considered the proposed rule's impact on efficiency,
competition, and capital formation. See 15 U.S.C. 78c(f).
    \9\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Commission finds good cause for approving this proposal before
the 30th day after the publication of notice thereof in the Federal
Register. The proposal seeks to conform the Exchange's fees charged for
linkage transactions in Non-Penny Pilot Classes with the fees charged
for transactions to BOX Participants in the same Non-Penny Pilot
Classes. The Commission notes that the proposal would reduce net costs
for both inbound and outbound Linkage Orders. The Exchange requests
that the effective date of the proposed rule change be August 3, 2009.
The Commission believes that accelerating approval of this proposal
would allow the Exchange to implement this new Linkage Fee in
conjunction with the implementation of other related transactions fees
on August 3, 2009 and would allow the fees/credits applicable to
Linkage Orders to conform to such other fees.

V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\10\ that the proposed rule change (SR-BX-2009-045) be, and it
hereby is, approved on an accelerated basis.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-19016 Filed 8-7-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: November 3, 2005 (Volume 70, Number 212)]
[Notices]
[Page 66827]
[DOCID:fr03no05-40]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-44-000]

Northwest Pipeline Corporation; Notice of Proposed Changes in
FERC Gas Tariff ND Filing of Non-Conforming Service Agreement

October 27, 2005.
    Take notice that on October 21, 2005, Northwest Pipeline
Corporation (Northwest) tendered for filing as part of its FERC Gas
Tariff, Third Revised Volume No. 1, Eighth Revised Sheet No. 371 to
become effective November 21, 2005. Northwest further states that it
also tendered for filing a Rate Schedule TF-1 non-conforming service
agreement.
    Any person desiring to intervene or to protest this filing 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). 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. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of 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 e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E5-6075 Filed 11-2-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 8 (Wednesday, January 12, 2011)]
[Proposed Rules]
[Pages 2066-2070]
[FR Doc No: 2011-343]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2009-0729; FRL-9250-7]

Approval and Promulgation of Implementation Plans; Indiana;
Removal of Vehicle Inspection and Maintenance Programs for Clark and
Floyd Counties

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve a State Implementation plan (SIP)
revision submitted by the State of Indiana to allow the State to
discontinue the vehicle inspection and maintenance (I/M) program in
Clark and Floyd Counties, IN, the Indiana portion of the Louisville
(IN-KY) 1997 8-hour ozone area. The revision specifically requests that
I/M program regulations be removed from the active control measures
portion of the SIP. The regulations will remain in the contingency
measures portion of the Clark and Floyd Counties ozone maintenance
plans. The Indiana Department of Environmental Management (IDEM)
submitted this request on October 10, 2006, and supplemented it on
November 15, 2006, November 29, 2007, November 25, 2008, April 23,
2010, and November 19, 2010. EPA is proposing to approve Indiana's
request because the State has demonstrated that discontinuing the I/M
program in Clark and Floyd Counties will not interfere with the
attainment and maintenance of the 8-hour ozone National Ambient Air
Quality Standard (NAAQS) or with the attainment and maintenance of
other air quality standards and requirements of the Clean Air Act
(CAA).

DATES: Comments must be received on or before February 11, 2011.

ADDRESSES: Submit comments, identified by Docket ID No. EPA-R05-OAR-
2009-0729, by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: Douglas Aburano, Chief, Control Strategies Section, (AR-
18J), U.S. Environmental Protection Agency, 77 West Jackson Boulevard,
Chicago, Illinois 60604.
    5. Hand Delivery: Douglas Aburano, Chief, Control Strategies
Section, (AR-18J), U.S. Environmental Protection Agency, 77 West
Jackson Boulevard, Chicago, Illinois 60604. Such deliveries are only
accepted during the Regional Office normal hours of operation, and
special arrangements should be made for deliveries of boxed
information. The Regional Office official hours of business are Monday
through Friday, 8:30 a.m. to 4:30 p.m., excluding Federal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R05-OAR-
2009-0729. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov website
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional instructions on submitting
comments, go to Section I of the SUPPLEMENTARY INFORMATION section of
this document.
    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Environmental
Protection Agency, Region 5, Air and Radiation Division, 77 West
Jackson Boulevard, Chicago, Illinois 60604. This Facility is open from
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal
holidays. We recommend that you telephone Francisco J. Acevedo at (312)
886-6061 before visiting the Region 5 office.

FOR FURTHER INFORMATION CONTACT: Francisco J. Acevedo, Environmental
Protection Specialist, Control Strategies Section, Air Programs Branch
(AR-18J), U.S. Environmental Protection Agency, Region 5, 77 West
Jackson Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This SUPPLEMENTARY INFORMATION
section is arranged as follows:

I. What should I consider as I prepare my comments for EPA?
    A. Submitting CBI
    B. Tips for Preparing Your Comments

II. What are EPA's proposed actions
III. What changes to the Indiana SIP have been submitted to support
the removal of the I/M program in Clark and Floyd Counties?
IV. What criteria apply to Indiana's request?
V. Has Indiana met the criteria for converting the I/M program in
Clark and Floyd Counties to contingency measures?
VI. What are our conclusions concerning the removal of the I/M
program in Clark and Floyd Counties?
VII. Statutory and Executive Order Reviews

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

A. Submitting CBI

    Do not submit this information to EPA through http://www.regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI). In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.

B. Tips for Preparing Your Comments

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

II. What are EPA's proposed actions?

    EPA is proposing to approve a SIP revision submitted by the State
of Indiana to modify the ozone SIP such that the I/M program in Clark
and Floyd Counties (the Indiana portion of the Louisville (IN-KY) 1997
8-hour ozone area) is no longer an active program in this area and
remains instead as a contingency measure in this area's maintenance
plan for 1997 8-hour ozone.

III. What changes to the Indiana SIP have been submitted to support the
removal of the I/M program in Clark and Floyd Counties?

    Indiana House Enrolled Act No. 1798, effective on July 1, 2003,
amended Indiana code 13-17-5 to eliminate the applicability of the
vehicle emissions testing rule to Clark and Floyd Counties after
December 31, 2006, at which time the program ceased operations. IDEM
submitted a revision to the Indiana SIP for Clark and Floyd Counties
(the Indiana portion of the Louisville (IN-KY) 1997 8-hour ozone
nonattainment area) on October 10, 2006, requesting that the Indiana I/
M program in Clark and Floyd Counties be moved from the active control
measures portion of the SIP to the contingency measures portion of the
Clark and Floyd Counties 1997 8-Hour Ozone Maintenance Plan.
    Clark and Floyd Counties were originally required to implement
``basic'' I/M programs under section 182(b)(4) of the CAA because they
had been designated as part of the Louisville moderate 1-hour ozone
nonattainment area. In order to maximize the emissions reductions from
the I/M program, IDEM chose to implement an ``enhanced'' program in
those areas and incorporated an on-board diagnostic (OBD) component
into the program. EPA fully approved Indiana's I/M program on March 19,
1996 (61 FR 11142). The enhanced I/M program component began operation
in 1997, to help meet nonattainment area requirements for the ozone
NAAQS effective at the time.\1\ The Louisville 1-hour ozone
nonattainment area was redesignated to attainment for that standard on
October 23, 2001 (66 FR 53665).
---------------------------------------------------------------------------

    \1\ Although the enhanced I/M program component began in 1997,
there was a vehicle I/M program operating in the Clark and Floyd
Counties prior to that date, and prior to November 15, 1990.
---------------------------------------------------------------------------

    Subsequently, Clark and Floyd Counties were designated as a portion
of the IN-KY Louisville nonattainment for the 1997 8-hour ozone NAAQS.
On November 15, 2006, IDEM submitted a request to redesignate the
Indiana portion of the Louisville nonattainment area to attainment for
the 8-hour NAAQS, and for EPA approval of a 14-year maintenance plan
for Clark and Floyd Counties. At the same time, IDEM requested EPA
approval to terminate the I/M program in these counties. EPA approved
the redesignation and maintenance plan for Clark and Floyd Counties on
July 19, 2007 (72 FR 39571). The approved maintenance plan demonstrated
that the area could maintain the standard without the need for emission
reductions from I/M. See 72 FR 26057, 26064-26065 (May 8, 2007).
    The Louisville 1997 8-hour ozone nonattainment area also includes
Jefferson County, Kentucky. EPA approved the discontinuation of the I/M
program in Jefferson County on May 18, 2005, at 70 FR 28429.

IV. What criteria apply to Indiana's request?

    Areas designated nonattainment for the ozone NAAQS and classified
``moderate'' are required by the CAA to implement vehicle I/M. See CAA
section 182(b)(4).\2\ The Louisville area was previously designated
moderate nonattainment for the 1-hour ozone standard, prompting the
requirement for I/M. However, as noted above, the Louisville area was
redesignated to attainment for the 1-hour standard, and the 1-hour
standard has been revoked. While Clark and Floyd Counties were
designated nonattainment for the 0.08 ppm 8-hour ozone standard, they
were not classified for that standard.\3\ Thus, these areas are not
currently required to have I/M programs under the CAA and the State may
move them to the contingency measures portion of the SIP,\4\ provided
the State can satisfy the anti-backsliding requirements of the CAA
(sections 110(l) and 193) and of EPA's ozone implementation rule, 40

CFR 51.905. As previously noted, EPA in approving the area's
maintenance plan for the 1997 8-hour ozone standard concluded that it
demonstrated maintenance without reliance on any emissions reductions
from the I/M program.
---------------------------------------------------------------------------

    \2\ Certain areas classified ``marginal'' are also required to
implement I/M. See CAA section 182(a)(2)(B).
    \3\ Clark and Floyd Counties were classified ``basic'' (i.e.,
subject to subpart 1) for the 0.08 parts per million (ppm) 8-hour
ozone standard but that classification was vacated by a decision of
the United States Court of Appeals for the D.C. Circuit. See South
Coast Air Quality Management Dist. v. EPA, 472 F.3d 882 (D.C. Cir.
2006). EPA is in the process of responding to that decision through
rulemaking. EPA promulgated a 0.075 ppm 8-hour ozone standard but
subsequently announced that it was reconsidering that standard and
in January 2010 proposed to change it. EPA has not designated areas
for the 0.075 ppm 8-hour ozone standard that is being reconsidered.
    \4\ As discussed below, the measures must be retained as
contingency measures because CAA section 175A(d) requires that the
contingency measures portion of the SIP include a requirement that
the State will implement all measures that were contained in the SIP
before the area was redesignated to attainment.
---------------------------------------------------------------------------

    CAA section 110(l) provides:

    The Administrator shall not approve a revision of a plan if the
revision would interfere with any applicable requirement concerning
attainment and reasonable further progress (as defined in section
171), or any other applicable requirement of this Act.

    In addition, EPA adopted anti-backsliding requirements as part of
the implementation rule for the 0.08 ppm 8-hour ozone standard. See 40
CFR 51.905. For areas such as these that were required under the CAA to
implement basic I/M, EPA applies the provisions of the implementation
rule in concert with the provisions of 40 CFR 51.372(c).
    The provisions of 40 CFR 51.372(c) allow certain areas seeking
redesignation to submit only the authority for an I/M program (together
with certain commitments), rather than an implemented program, in
satisfaction of the applicable I/M requirements. Under these I/M rule
provisions, a basic I/M area (i.e., an area that was required to adopt
a basic I/M program) which has been redesignated to attainment for the
1-hour ozone NAAQS can convert the I/M program to a contingency measure
as part of the area's 1-hour ozone maintenance plan, notwithstanding
the anti-backsliding provisions in EPA's 8-hour ozone implementation
rule published April 30, 2004 (69 FR 23858). A basic I/M area which is
designated nonattainment for the 8-hour ozone NAAQS, yet is not
required to have an I/M program based on its 8-hour ozone
classification, continues to have the option to move its I/M program to
a contingency measure pursuant to the provisions of 40 CFR 51.372(c),
provided the 8-hour ozone nonattainment area can demonstrate that doing
so will not interfere with its ability to comply with any NAAQS or any
other applicable CAA requirement pursuant to section 110(l) of the Act.
For further details on the application of 8-hour ozone anti-backsliding
provisions to basic I/M programs in 1-hour ozone maintenance areas,
please refer to the May 12, 2004, EPA Memorandum from Tom Helms, Group
Leader, Ozone Policy and Strategies Group, Office of Air Quality
Planning and Standards, and Leila H. Cook, Group Leader, State Measures
and Conformity Group, Office of Transportation and Air Quality, to the
Air Program Managers, the subject of which is ``1 Hour Ozone
Maintenance Plans Containing Basic I/M Programs.'' A copy of this
memorandum may be obtained at http://www.epa.gov/ttn/oarpg/t1pgm.html
under the file date ``5-12-04.''

V. Has Indiana met the criteria for converting the I/M program in Clark
and Floyd Counties to contingency measures?

    Clark and Floyd Counties were redesignated to attainment of the 1-
hour ozone NAAQS on October 23, 2001 (66 FR 53665). On July 19, 2007
(72 FR 39571), EPA approved the redesignation of Clark and Floyd
Counties to attainment with respect to the 8-hour ozone NAAQS. EPA
approved maintenance plans with respect to each of these standards in
connection with these redesignations. The approved maintenance plans
show that control measures in place in these areas are sufficient for
overall emissions to remain beneath the attainment level of emissions
until the end of the maintenance period, even without operation of I/M.
In both plans, the conformity budget in the maintenance plans reflects
mobile source emissions without I/M in future years, and the
maintenance plans demonstrate that the applicable standard will
continue to be met without I/M. In accordance with the Act and EPA
redesignation guidance, states are free to adjust control strategies in
the maintenance plan as long as they can satisfy section 110(l). With
such a demonstration of noninterference with attainment or other
applicable requirements, control programs may be discontinued and
removed from the SIP. However, section 175A(d) of the CAA requires that
contingency measures in the maintenance plan include all measures in
the SIP for the area before that area was redesignated to attainment.
Since the I/M program was in the SIP prior to redesignation to
attainment for ozone, the I/M program must be included in the
contingency portion of the ozone maintenance plan as required by
section 175A(d). As part of its submittal, IDEM provided a
demonstration showing continued maintenance of the 8-hour ozone
standard without taking credit for reductions from the Clark and Floyd
Counties I/M program after December 2006.
    As discussed above, EPA interprets its regulations as allowing
basic I/M areas such as these to have the option to move an I/M program
to a contingency measure pursuant to 40 CFR 51.372(c), provided that
moving I/M to contingency measures will not interfere with the area's
ability to comply with any NAAQS or any other applicable CAA
requirement (including section 193). Under 40 CFR 51.372(c), an area is
required to include in its submittal, with a request to place the I/M
program into the contingency measures: (1) Legal authority to implement
a basic I/M program; (2) a commitment by the Governor of the State, or
the Governor's designee, to adopt or consider adopting regulations to
implement an I/M program to correct a violation of the ozone or carbon
monoxide standard, in accordance with the maintenance plan; and (3) a
contingency commitment that includes an enforceable schedule, with
appropriate milestones, for adoption and implementation of an I/M
program.
    In the State's supplemental submittal of November 25, 2008, IDEM
reaffirms that Indiana has retained the necessary legal authority to
implement I/M under Indiana Code 13-17-5. EPA examined the applicable
Indiana statutory language and the State's subsequent legal review and
concurs with Indiana's finding that it has the necessary legal
authority to implement I/M if it becomes necessary under the CAA to
implement contingency measures. In addition, the State's supplemental
submittal includes a commitment by IDEM to consider the adoption of I/M
as a corrective measure should an ambient 8-hour ozone design value
trigger a contingency measure in Clark and Floyd Counties, and the
required program is determined by the State to be an I/M program. The
State's supplemental submittal of April 23, 2010, also contains an I/M
implementation schedule in the event that I/M is selected by the State
as a corrective measure, as required by 40 CFR 51372(c).
    As mentioned above, on July 19, 2007 (72 FR 39571), EPA concluded
that Clark and Floyd Counties met the 0.08 ppm ozone air quality
standard and redesignated this area to attainment for that standard.
The maintenance plan for this area shows that the area will continue to
attain the standard even with the discontinuation of I/M.
    As noted above, the 1997 8-hour maintenance plan estimated the
levels of volatile organic compounds (VOC) and oxides of nitrogen
(NOX) emissions in the area associated with attainment of
the respective ozone standards, and found that emissions would remain
below those quantities even with the discontinuation of I/M.
Furthermore, the maintenance plan demonstrates that current emissions
of VOC and NOX, without the I/M program, are lower than
emissions were in 2005, representing emissions when I/M was still
operating.

    EPA has also compared the expected reductions of VOC and
NOX from the I/M program with the reduction of emissions
that have resulted from the Federal Motor Vehicle Control Program and
other emission control programs since the I/M program ceased operation.
EPA concludes that the ongoing reductions from implementation of these
programs, particularly the Tier II standards for motor vehicles,\5\ are
greater than the emissions reductions that would have been achieved
from the I/M program.
---------------------------------------------------------------------------

    \5\ See 65 FR 6698 (February 10, 2000).
---------------------------------------------------------------------------

    On March 27, 2008 (73 FR 16436), EPA revised the ozone standard to
0.075 ppm as an 8-hour average.\6\ EPA therefore examined whether
discontinuation of the I/M program in Clark and Floyd Counties might
interfere with attainment and maintenance of this standard. The most
direct evidence regarding this issue is the most recent three years of
air quality data. Since the I/M program in Clark and Floyd Counties was
discontinued in 2006, the most recent three years have all reflected
emissions without operation of an I/M program in Clark and Floyd
Counties. All ozone monitoring sites in the Louisville area are meeting
the 0.075 ppm air quality standard, with the highest design value at
0.075 ppm, observed at the Watson Elementary site in Jefferson County,
Kentucky (site 21-111-0051). Ozone air quality in the 2007 to 2009
period, representing a period in which the I/M program was
discontinued, attains the ozone NAAQS and is better than ozone air
quality in the 2004 to 2006, representing the last three years in which
the program operated. Furthermore, Indiana's ozone maintenance plan for
this area shows a continuing decline in the emissions of ozone
precursors.
---------------------------------------------------------------------------

    \6\ As noted in footnote 3 above, EPA is in the process of
reconsidering this standard.
---------------------------------------------------------------------------

    On November 19, 2010, Indiana submitted modeling analyses that
further support the conclusion that the discontinuation of the I/M
program in Clark and Floyd Counties will not interfere with attainment
and maintenance of the 0.075 ppm ozone standard. This submittal reviews
analyses conducted by EPA and by the Lake Michigan Air Directors
Consortium (LADCO), in both cases reflecting no operation of an I/M
program in Clark and Floyd Counties. These analyses indicate that the
Louisville area can be expected to continue to attain the 0.075 ppm
ozone standard without I/M in Clark and Floyd Counties. Most notably,
Indiana reviews the modeling conducted by EPA in support of its
proposed transport rule, showing that the Louisville area can be
expected to continue to attain the 0.075 ppm ozone standard in 2012 not
only with the discontinuation of the I/M program in Clark and Floyd
Counties but also with the discontinuation of power plant emission
controls mandated by the Clean Air Interstate Rule. Thus, these
modeling analyses provide further evidence that the discontinuation of
the I/M program in Clark and Floyd Counties will not interfere with
attainment and maintenance of the 0.075 ozone standard in the
Louisville area.
    EPA also examined whether discontinuation of the I/M program might
interfere with attainment of the annual fine particulate matter
(PM2.5) standards. Since Indiana discontinued its I/M
program at the end of 2006, the PM2.5 air quality from 2007
to 2009 are indicative of whether the Louisville area can be expected
to attain the annual PM2.5 standard notwithstanding the
discontinuation of Indiana's I/M program. In a separate rulemaking
proceeding, published on September 14, 2010 (75 FR 55725), EPA has
proposed to determine that the Louisville area is now attaining the
annual PM2.5 standards.\7\ Furthermore, mobile source
emissions affecting PM2.5 concentrations are continuing to
decline, as a result of the Federal Motor Vehicle Control Program.\8\
---------------------------------------------------------------------------

    \7\ EPA received no comments on that proposal and will take
final action on that determination before taking final action on
Indiana's I/M shutdown request for Clark and Floyd Counties.
    \8\ As noted above, the Tier II standards are further reducing
emissions of new vehicles from the 2004 to the 2009 model years.
---------------------------------------------------------------------------

    EPA also examined whether cessation of the I/M program has
interfered with attainment of other air quality standards. The
Louisville area is designated attainment for the coarse particulate
matter (PM10) standard, for the 24-hour PM2.5
standards promulgated on July 18, 1997, and October 17, 2006, for
carbon monoxide, for sulfur dioxide, and for nitrogen dioxide. EPA has
no reason to believe that discontinuation of the I/M program in Clark
and Floyd Counties has caused or will cause the Louisville area to
become nonattainment for any of these pollutants. In addition, EPA
believes that the discontinuation of the I/M program in Clark and Floyd
Counties will not interfere with the area's ability to meet any other
CAA requirement.

VI. What are our conclusions concerning the removal of the I/M program
in Clark and Floyd Counties?

    For the reasons discussed above, EPA believes that Indiana has
satisfied currently applicable criteria for discontinuing I/M in Clark
and Floyd Counties. We are proposing to find that the State of Indiana
has demonstrated that eliminating the I/M program in Clark and Floyd
Counties is consistent with the requirements of sections 110(l) and 193
of the Clean Air Act. Accordingly, we are proposing to approve
Indiana's request to modify the SIP such that I/M is no longer an
active program in these areas and is instead a contingency measure in
this area's maintenance plan.

VII. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National

Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note)
because application of those requirements would be inconsistent with
the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Intergovernmental relations, Ozone, Particulate matter, Volatile
organic compounds.

    Dated: December 22, 2010.
Susan Hedman,
Regional Administrator, Region 5.
[FR Doc. 2011-343 Filed 1-11-11; 8:45 am]
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[Federal Register: July 10, 2008 (Volume 73, Number 133)]
[Notices]
[Page 39738-39739]
[DOCID:fr10jy08-102]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Rule 17Ad-3(b); SEC File No. 270-424; OMB Control No. 3235-0473.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
     Rule 17Ad-3(b) (17 CFR 240.17Ad-3(b)).
    Rule 17Ad-3(b) requires registered transfer agents that for each of
two consecutive months have failed to turnaround at least 75% of all
routine items in accordance with the requirements of Rule 17Ad-2(a) or
to

process at least 75% of all routine items in accordance with the
requirements of Rule 17Ad-2(a) to send to the chief executive officer
of each issuer for which such registered transfer agent acts a copy of
the written notice required under Rule 17Ad-2(c), (d), and (h). The
issuer may use the information contained in the notices in several
ways: (1) To provide an early warning to the issuer of the transfer
agent's non-compliance with the Commission's minimum performance
standards regarding registered transfer agents, and (2) to assure that
issuers are aware of certain problems and poor performances with
respect to the transfer agents that are servicing the issuer's
securities. If the issuer does not receive notice of a registered
transfer agent's failure to comply with the Commission's minimum
performance standards, then the issuer will be unable to take remedial
action to correct the problem or to find another registered transfer
agent. Pursuant to Rule 17Ad-3(b), a transfer agent that has already
filed a Notice of Non-Compliance with the Commission pursuant to Rule
17Ad-2 will only be required to send a copy of that notice to issuers
for which it acts when that transfer agent fails to turnaround 75% of
all routine items or to process 75% of all items.
    The Commission estimates that only two transfer agents will meet
the requirements of Rule 17Ad-3(b). If a transfer agent fails to meet
the minimum requirements under 17Ad-3(b), such transfer agent is simply
sending a copy of a form that had already been produced for the
Commission. The Commission estimates a requirement will take each
respondent approximately one hour to complete, for a total annual
estimate burden of two hours at cost of approximately $60.00 for each
hour.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
functions for 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.
    Please direct your written comments to Lewis W. Walker, Acting
Director/Chief Information Officer, Securities and Exchange Commission,
C/O Shirley Martinson, 6432 General Green Way, Alexandria, Virginia
22312; or send an e-mail to<EMAIL_ADDRESS>
    Dated: July 2, 2008.
Florence E. Harmon,
Acting Secretary.
 [FR Doc. E8-15642 Filed 7-9-08; 8:45 am]

BILLING CODE 8010-01-P