[Federal Register Volume 88, Number 60 (Wednesday, March 29, 2023)]
[Notices]
[Pages 18549-18550]
[FR Doc No: 2023-06482]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-0488]

Orthopedic Non-Spinal Bone Plates, Screws, and Washers--Premarket
Notification (510(k)) Submissions; Draft Guidance for Industry and Food
and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Orthopedic Non-Spinal
Bone Plates, Screws, and Washers--Premarket Notification (510(k))
Submissions.'' This draft guidance document provides recommendations
for information to include in 510(k) submissions for non-resorbable
bone plate, screw, and washer devices. The scope of this draft guidance
includes devices that are indicated for orthopedic bone fixation but
does not include devices indicated for spinal, mandibular,
maxillofacial, cranial, and orbital fracture fixation. This draft
guidance is not final nor is it for implementation at this time.

DATES: Submit either electronic or written comments on the draft
guidance by May 30, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-D-0488] for ``Orthopedic Non-Spinal Bone Plates, Screws, and
Washers--Premarket Notification (510(k)) Submissions.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this

information on the cover sheet and not in the body of your comments and
you must identify this information as ``confidential.'' Any information
marked as ``confidential'' will not be disclosed except in accordance
with 21 CFR 10.20 and other applicable disclosure law. For more
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Orthopedic Non-Spinal Bone Plates, Screws, and Washers--Premarket
Notification (510(k)) Submissions'' to the Office of Policy, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your request.

FOR FURTHER INFORMATION CONTACT: Mahlet Zinah, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4452, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Non-spinal, non-resorbable bone plates, screws, and washers are
implants intended for bone fixation. These are class II medical devices
for which the safety and effectiveness are well-established. This draft
guidance provides recommendations for the content and organization of
premarket notification (510(k)) submissions including the information
FDA recommends industry include in a 510(k) submission for these device
types (e.g., non-clinical testing, sterility, reprocessing,
biocompatibility). This draft guidance is intended to facilitate
consistency in information provided in submissions by addressing common
deficiencies related to device description and performance testing and
by identifying applicable cross-cutting guidances and consensus
standards.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Orthopedic
Non-Spinal Bone Plates, Screws, and Washers--Premarket Notification
(510(k)) Submissions.'' It does not establish any rights for any person
and is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov and https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to
download an electronic copy of ``Orthopedic Non-Spinal Bone Plates,
Screws, and Washers--Premarket Notification (510(k)) Submissions'' may
send an email request to [email protected] to receive an
electronic copy of the document. Please use the document number
GUI00019023 and complete title to identify the guidance you are
requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it
does refer to previously approved FDA collections of information.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in the following FDA regulations and guidance have been
approved by OMB as listed in the following table:

----------------------------------------------------------------------------------------------------------------
                 21 CFR part or guidance                                 Topic                  OMB control No.
----------------------------------------------------------------------------------------------------------------
807, subpart E..........................................  Premarket Notification.............          0910-0120
812.....................................................  Investigational Device Exemption...          0910-0078
``Requests for Feedback & Meetings for Medical Device     Q-submissions; Pre-submissions.....          0910-0756
 Submissions: The Q-Submission Program''.
800, 801, and 809.......................................  Medical Device Labeling Regulations          0910-0485
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    Dated: March 23, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-06482 Filed 3-28-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: January 3, 2008 (Volume 73, Number 2)]
[Notices]
[Page 523-524]
[DOCID:fr03ja08-58]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57052; File No. SR-Amex-2007-140]

Self-Regulatory Organizations; American Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
Relating to Options Licensing Fee Changes

December 27, 2007.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on December 21, 2007, the American Stock Exchange LLC (``Amex'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been substantially prepared by the Exchange.
The Exchange has designated this proposal as one establishing or
changing a due, fee, or other charge applicable only to a member,
pursuant to section 19(b)(3)(A)(ii) of the Act \3\ and Rule 19b-4(f)(2)
thereunder,\4\ which renders the proposal effective upon filing with
the Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Amex proposes to modify its Options Fee Schedule.
    The text of the proposed rule change is available at the Exchange,
on the Exchange's Web site at http://www.amex.com, and at the

Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange has entered into numerous agreements with index
providers for the purpose of trading index options. The requirement to
pay an index license fee to such third parties is a condition to the
listing and trading of these index options. In many cases, the Exchange
is required to pay a significant licensing fee to issuers or index
owners that may not be reimbursed. In an effort to recoup the costs
associated with index licenses, the Exchange has previously established
a per-contract licensing fee for firms, specialists, registered options
traders (``ROTs''), remote registered options traders (``RROTs''),
supplemental registered options traders (``SROTs''), non-member market
makers, and broker-dealers that is collected on every transaction in
designated products in which a firm, specialist, ROT, RROT, SROT, non-
member market maker, or broker-dealer is a party. The licensing fees
currently imposed are set forth in the Exchange's Options Fee Schedule.
    The Exchange is proposing to amend its Options Fee Schedule to
increase the licensing fees for options on the Nasdaq-100 Index (NDX)
and Mini-Nasdaq-100 Index (MNX). Currently, the licensing fees for
these index options are $0.15 per contract side. As a result of a
recent change to the licensing agreement for NDX and MNX, the Exchange
is now being charged a higher license fee. Accordingly, the Exchange
now proposes to charge $ 0.16 per contract side for NDX and MNX
options, effective January 2, 2008.
    The Exchange submits that the proposed license fee will provide the
Exchange with additional revenue and allow the Exchange to recoup its
costs associated with the trading of NDX and MNX options. Furthermore,
the Amex believes that this fee will help to allocate to those firms,
specialists, ROTs, RROTs, SROTs, non-member market makers, and broker-
dealers transacting in NDX and MNX options a fair share of the related
costs of offering such options. Accordingly, the Exchange believes that
the proposed fee is reasonable.
    The Exchange asserts that the proposal is equitable as required by
section 6(b)(4) of the Act.\5\
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    \5\ Section 6(b)(4) requires that the rules of a national
securities exchange provide for the equitable allocation of
reasonable dues, fees, and other charges among its members and
issuers and other persons using its facilities. 15 U.S.C. 78f(b)(4).

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2. Statutory Basis
    The proposed fee change is consistent with section 6(b)(4) of the
Act \6\ regarding the equitable allocation of reasonable dues, fees,
and other charges among exchange members and other persons using
exchange facilities.
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    \6\ 15 U.S.C. 78f(b)(4).
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B. Self-Regulatory Organization's Statement on Burden on Competition

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

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

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

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

    Because the foregoing rule change is establishing or changing a
due, fee, or other charge applicable only to a member, it has become
effective pursuant to section 19(b)(3)(A)(ii) of the Act \7\ and Rule
19b-4(f)(2) thereunder.\8\ At any time within 60 days of the filing of
such proposed rule change the Commission may summarily abrogate such
rule change if it appears to the Commission that such action is
necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act.
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    \7\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \8\ 17 CFR 240.19b-4(f)(2).
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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 Number SR-Amex-2007-140 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Amex-2007-140. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the 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-Amex-2007-140 and should be
submitted on or before January 24, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
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    \9\ 17 CFR 200.30-3(a)(12).
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Nancy M. Morris,
Secretary.
[FR Doc. E7-25569 Filed 1-2-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 76 (Wednesday, April 20, 2022)]
[Notices]
[Pages 23506-23507]
[FR Doc No: 2022-08369]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2232-828]

Duke Energy Carolinas, LLC; Notice of Application Accepted for
Filing and Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Request for a temporary amendment of the
reservoir elevation requirement at the Wateree development.

    b. Project No.: 2232-828.
    c. Date Filed: January 25, 2022.
    d. Applicant: Duke Energy Carolinas, LLC.
    e. Name of Project: Catawba-Wateree Hydroelectric Project.
    f. Location: The project is located on the Catawba-Wateree River in
Burke, McDowell, Caldwell, Catawba, Alexander, Iredell, Mecklenburg,
Lincoln, and Gaston counties, North Carolina, and York, Lancaster,
Chester, Fairfield, and Kershaw counties South Carolina.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Mr. Jeffrey G. Lineberger, Director of Water
Strategy and Hydro Licensing, Duke Energy, Mail Code EC-12Q, 526 South
Church Street, Charlotte, NC 28202,<PHONE_NUMBER>.
    i. FERC Contact: Mr. Steven Sachs,<PHONE_NUMBER>,
[email protected].
    j. Deadline for filing comments, motions to intervene, and protests
is 30 days from the issuance of this notice by the Commission. The
Commission strongly encourages electronic filing. Please file comments,
motions to intervene, and protests using the Commission's eFiling
system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/doc-sfiling/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at [email protected],<PHONE_NUMBER> (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, you may
submit a paper copy. Submissions sent via the U.S. Postal Service must
be addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Submissions sent via any other carrier must be addressed to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, MD 20852. The first page of any filing should
include docket number P-2232-828.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person on the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    k. Description of Request: The applicant requests a temporary
variance of its reservoir elevation requirement at the Wateree
development. The applicant intends to maintain the water surface
between 6 and 7 feet below the full pool elevation of 100 feet local
datum for 11 to 16 months beginning in the third quarter of 2022. This
differs from the normal target elevation which is 3 feet below full
pool (97 feet local datum) from March through November and 5 to 5.5
feet below full pool (95 to 94.5 feet local datum) at all other times,
and compares to the normal minimum elevation which is 6 feet below full
pool (94 feet local datum) from March through October, and 7 feet below
full pool (93 feet local datum) the reminder of the year. The applicant
states the low reservoir elevation would allow it to install pneumatic
crest gates on the Wateree dam.
    l. In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://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 at [email protected] or call toll-
free,<PHONE_NUMBER> or TYY,<PHONE_NUMBER>.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Motions to Intervene, or Protests: Anyone may submit
comments, a motion to intervene, or a protest in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, motions to
intervene, or protests must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents: Any filing must (1)
bear in all capital letters the title ``COMMENTS'', ``MOTION TO
INTERVENE'', or ``PROTEST'' as applicable; (2) set forth in the heading
the name of the applicant and the project number(s) of the application
to which the filing responds; (3) furnish the name, address, and
telephone number of the person intervening or protesting; and (4)
otherwise comply with the requirements of 18 CFR 385.2001 through
385.2005. All comments, motions to intervene, or protests must set
forth their evidentiary basis. A copy of all other filings in reference
to this application must be accompanied by proof of service on all
persons listed in the service list prepared by the Commission in this
proceeding, in accordance with 18 CFR 385.2010.

    Dated: April 13, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-08369 Filed 4-19-22; 8:45 am]
BILLING CODE 6717-01-P


Date: March 8, 2006 From: Thomas Holloway Subject: National Emission Standards for Magnetic Tape Manufacturing Operations  Summary of Public Comments and EPA Responses To: Lynn Dail ESD/ CCPG ( C539 03) U. S. Environmental Protection Agency ( EPA) Research Triangle Park, NC 27711 I. Introduction On October 24, 2005, the U. S. Environmental Protection Agency ( EPA) proposed taking no further action at this time to revise the national emission standards for hazardous air pollutants ( NESHAP) for magnetic tape manufacturing operations, based on findings from the residual risk review and technology review for the source category. In the proposed action, EPA requested public comment on the residual risk review and technology review and on issues of delisting the source category and conducting future technology reviews. The purpose of this memorandum is to present a summary of the public comments received and EPA's responses to the comments.

By the end of the public comment period, comments from five entities had been received. The commenters ( and the document numbers assigned to their comments) are listed below:

STAPPA/ ALAPCO ( EPA HQ OAR 2003 0161 0107) The American Chemistry Council ( EPA HQ OAR 2003 0161 0108) Residual Risk Coalition ( EPA HQ OAR 2003 0161 0109) Alliance of Automobile Manufacturers ( EPA HQ OAR 2003 0161 0110) The AN Group ( EPA HQ OAR 2003 0161 0111)

II. Summary of Comments and Responses A. Residual Risk Determination Comment: Commenters EPA HQ OAR 2003 0161 0108,  0109, and  0110 ( hereafter referred to as commenters 0108, 0109, and 0110) supported EPA's decisions for the magnetic tape source category. The commenters 0108, 0109, and 0110 supported EPA's conclusion that no changes to the existing NESHAP for magnetic tape manufacturing were required to satisfy the requirements of section 112( f). The commenters noted that EPA correctly reviewed the magnetic tape sources, followed the tiered risk assessment approach described in its Residual Risk Report to Congress, and, using a conservative methodology, determined that no source in the category had a maximum individual cancer risk exceeding the 1 in 1 million level for triggering promulgation of a residual risk standard under section 112( f). 2 Commenters 0108 and 0109 stated that EPA was correct to focus its section 112( f) residual risk analysis on the sources in the magnetic tape source category subject to section 112( d) requirements, and not consider risk from outside that source category. According to the commenters, the statutory language and construction of section 112( f) shows that Congress was directing EPA to perform residual risk analyses for individual source categories.

Response: We acknowledge the commenters' support for our health protective methodology and our conclusions in the proposed notice. Because risks from the magnetic tape source category did not exceed the statutory trigger of 1 in 1 million, we agree that it was appropriate to limit our analysis to the source category rather than also considering risks from other sources. However, we do not agree that our section 112( f) residual risk analyses must always focus only on the sources in the magnetic tape source category subject to section 112( d) requirements or that Congress intended to limit all residual risk analyses to the individual source categories in question. As we stated in the preamble to the Coke Ovens residual risk rule, " EPA disagrees that section 112( f) precludes EPA from considering emissions other than those from the source category or subcategory entirely." Rather, we have concluded that, when the statutory risk trigger is exceeded, the two step approach set forward in the Benzene NESHAP remains the approach that we should follow in determinations under section 112( f). At the first step, when determining " acceptable risk," we will consider risks that result from emissions from the source category only. However, during the second step, we must determine whether additional reductions should be required to protect public health with " an ample margin of safety." One of the factors that we can consider in this second step is environmental levels of hazardous air pollutants ( HAP) due to emissions from sources outside the source category being assessed. This could include ambient background concentrations of HAP, as well as co location of other emission sources that augment the identified risks from the source category.

B. Delisting the Source Category At proposal, we requested comment on whether it would be appropriate to delist the magnetic tape source category under section 112( c)( 9) based on the possibility that HAP emissions from the source category would be sufficiently low even in the absence of maximum achievable control technology ( MACT) standards.

Comment: Commenter EPA HQ OAR 2003 0161 0107 ( hereafter referred to as commenter 0107) opposed delisting the magnetic tape source category, stating that if the source category was delisted, there would be nothing to prevent sources from increasing their HAP emissions substantially or changing their processes to emit new HAP, resulting in HAP levels unacceptable to public health and the environment. The commenter indicated that such an approach ignores the possibility that HAP emissions were reduced to an acceptable level because of the MACT requirements and that emissions could increase again without the MACT standard in place. Furthermore, the commenter believed that Congress did not intend for the residual risk review to result in delisting of regulated source categories; if Congress had wanted to make delistings dependent on or linked to the outcome of the residual risk process, it would have specifically mandated this in the CAA, which it did not. 3 Commenters 0108 and 0109 argued that delisting a source category does not affect the applicability of an existing NESHAP and cited the delisting action following the Asbestos NESHAP as support for their argument. They also noted that EPA said in its proposal that no further section 112( d)( 6) reviews are required unless there is a significant change to the source category. Consequently, the commenters saw no benefit in delisting the magnetic tape source category. However, they were not opposed to such an action.

Commenter 0110 supported delisting the magnetic tape source category under the authority of section 112( c)( 9) based on EPA's finding of negligible risks ( 0.01 in 1 million). The commenter stated that EPA's request for comment implied that it interpreted the CAA to allow delisting on the basis of low risk only before a MACT standard is issued; however, section 112( c)( 9) provides EPA with the authority to delist a source category whenever the Administrator makes a determination that the risks are below the risk criteria in the CAA and does not limit this authority to sources not yet subject to a MACT standard or a generally available control technology ( GACT) standard. According to the commenter, limiting EPA's discretion to delist source categories prior to issuing MACT or GACT standards also conflicts with the required sequence of duties under section 112, which does not require EPA to conduct a risk analysis until a residual risk evaluation is required 8 years after MACT standards are issued; consequently, EPA is unlikely to have sufficient data on which to base a delisting decision until many years after MACT standards have been promulgated. Furthermore, the commenter stated it is possible that source categories found to be low risk after MACT standards were imposed may have been low risk before the standards were imposed, especially magnetic tape facilities, where the risk assessment showed risks two orders of magnitude below the statutory criteria for delisting under section 112( c)( 9). Finally, the commenter noted that if EPA was concerned that the source category would exceed risk levels if MACT controls were not applicable, it could use section 112( c)( 9) to keep in place those MACT requirements needed to sustain the low risk determination and delisting. According to the commenter, those requirements could be established as part of the delisting decision and maintained in the title V permit, as was done in the NESHAP for Plywood and Composite Wood Products.

Response: Based on our risk assessment of the magnetic tape source category, we have concluded that these sources are low risk and, therefore, that no further standards are required to protect public health with an ample margin of safety or to protect the environment. However, we agree with the commenter who argues that this conclusion is based, at least in part, on the fact that the MACT requirements for these sources limit HAP emissions. Further, we disagree with the comment that delisting will not affect the viability of the existing NESHAP. The commenter cited the delisting action following the Asbestos NESHAP as support for their argument, noting that the applicability of that rule was not affected by delisting. However, the Asbestos NESHAP was established under part 61, which is not directly relevant in this situation since the Magnetic Tape NESHAP is a part 63 rule. If we delist this source category, it is our conclusion that existing magnetic tape sources would no longer be subject to the NESHAP and, thus, HAP emissions would no longer be limited by this rule. If sources begin emitting HAP at levels exceeding those allowed under the NESHAP, risks could increase, and the basis for our finding that the source category is low risk could be compromised. We have already documented that emissions from magnetic tape manufacturing operations were substantially higher at promulgation, compared to more recent emissions estimates ( after the standards were 4 implemented). As noted in the October 24, 2005 proposal ( 70 FR 61419), HAP emissions at promulgation were estimated to be 4,060 megagrams per year ( Mg/ yr) ( 4,470 tons per year [ tpy]), while HAP emissions in 2000 were estimated to be 468 Mg/ yr ( 516 tpy)  a difference of almost 90 percent. ( These HAP emissions estimates include methyl ethyl ketone, which has since been delisted as a HAP.) Therefore, since compliance with the MACT standard is part of the basis for our low risk determination, we believe that it would be inappropriate to delist the magnetic tape source category.

Contrary to one commenter's contention, we did not intend to imply through our request for comments that we interpret section 112( c)( 9) of the CAA to apply only before a MACT standard has been promulgated. We were simply seeking comment on the use of section 112( c)( 9) after the MACT standard. However, as we argue above, use of section 112( c)( 9) to delist the magnetic tape source category is neither necessary nor appropriate, and we agree with the commenters who suggested that there would be no benefit to delisting this source category. Further, we do not agree that section 112( c)( 9) provides us the authority to impose requirements less stringent than MACT in order to sustain a low risk determination and delisting.

C. Future Technology Reviews At proposal, we requested comment on " the notion that, barring any unforeseeable circumstances which might substantially change this source category or its emissions, we would have no obligations to conduct future technology reviews under CAA section 112( d)( 6)." We suggested this approach because of the low risk finding for this source category under section 112( f).

Comment: Commenter 0107 disagreed that low risk from a source category at this time should absolve EPA of its obligation to conduct future technology reviews. The commenter stated that, without periodic reviews of source categories and technology in the future reviews, EPA would not be aware of any technologies that have been developed or any " unforeseeable circumstances" related to the source category to which EPA refers in the notice. Furthermore, the commenter believed that Congress did not intend for the residual risk review to result in the removal of EPA's obligation to conduct future technology reviews under section 112( d)( 6); if Congress had wanted to make technology reviews dependent on or linked to the outcome of the residual risk process, it would have specifically mandated this in the CAA, which it did not.

Commenters 0108, 0109, and 0110 stated that EPA has no obligation to conduct a technology review in the case of Magnetic Tape. According to the commenters, because the residual risk provisions of the CAA were not triggered by the magnetic tape source category's remaining low risk, even an initial technology review was unnecessary. The commenters noted that EPA only used the results of the section 112( f)( 2) residual risk analysis to conclude that future section 112( d)( 6) technology reviews would not be required. The commenters stated that EPA's use of a formal technology review as the basis for its conclusion under section 112( d)( 6) that the NESHAP did not need to be revised was inconsistent with EPA's prior stated position in the Coke Ovens residual risk rule ( 70 FR 20009) on determining the need for a technology review under section 112( d)( 6). Commenter 0109 stated that if the Coke Ovens criteria for when a technology review is not " necessary" under the CAA are sound for subsequent technology 5 reviews, then they are also sound for initial reviews, as in the case of Magnetic Tape. Commenter 0108 stated that, where the ample margin of safety set in the residual risk rule is largely based on cost or technical feasibility, then further future review under section 112( d)( 6) may remain viable, and additional controls may not be precluded if feasible, cost effective control measures are identified in the future.

Response: We stated in the preamble to the Coke Ovens residual risk rule that if the ample margin of safety analysis for the section 112( f) standard is not based at all on the availability or cost of particular control technologies, then advances in air pollution control technology should not justify revising the MACT standard pursuant to section 112( d)( 6) because the section 112( f) standard would continue to assure an adequate level of safety. We agree that a technology review is required every 8 years. However, if the ample margin of safety analysis for a section 112( f) standard shows that remaining risk for non threshold pollutants falls below 1 in 1 million and for threshold pollutants falls below a similar threshold of safety, then further revision should not be needed because an ample margin of safety has already been assured. In these situations, the development of new technology, or of inexpensive control strategies, would generally not cause us to require additional risk reductions for a source category. If the availability and/ or costs of technology are part of the rationale for the ample margin of safety determination, it is reasonable to conclude that changes in those costs or in the availability of technology could alter our conclusions regarding the ample margin of safety. For this reason, we agree with the comment that subsequent technology reviews would be appropriate and revisions may also be appropriate if the ample margin of safety established by the residual risk process considers cost or technical feasibility.

We disagree with the comment that we should not have conducted an initial technology review under section 112( d)( 6) for the magnetic tape source category. As we noted in the preamble to the Coke Ovens residual risk rule, we believe that the findings that underlie a section 112( f) determination should be key factors in making any subsequent section 112( d)( 6) determinations. As indicated by the inclusion of the word " subsequent" in this rationale, we believe that we are obligated to perform the initial section 112( d)( 6) analysis. The timing requirements for the initial section 112( d)( 6) analysis coincide with those for the residual risk analysis. Thus, it is appropriate for us to conduct both analyses at the same time and for the results of the risk analysis to impact future section 112( d)( 6) technology reviews, even though these results do not negate either the need to perform the initial review or the need to perform subsequent reviews under section 112( d)( 6).

D. General Approach to Technology Reviews Comment: Commenters 0108, 0109, and 0110 stated that action is not necessarily required under section 112( d)( 6) even if a residual risk rule does not reduce cancer risks for all persons to a level below 1 in 1 million. Commenters 0108 and 0109 noted that EPA had already rejected such a " bright line" approach under section 112( f) in the Coke Ovens residual risk rule; instead, it serves as a trigger point to evaluate whether additional reductions are necessary to provide an ample margin of safety. Commenter 0110 cited the legislative history of the 1990 amendments to the CAA as support that Congress had rejected provisions requiring sources to meet a 1 in 1 million standard. According to commenter 0110, EPA's proposed interpretation of 6 section 112( d)( 6) of requiring successive reviews unless sources achieve this risk level implies that sources must meet a 1 in 1 million standard to avoid future regulation, and if Congress had intended this " technology based" downward revision of the standard, there would have been no need for section 112( f).

Noting that EPA's risk estimates are upper bound estimates that likely overstate risks, commenters 0108 and 0109 stated that a " bright line" approach should not be employed under section 112( d)( 6) any more than it should be employed under section 112( f); instead, they stated that EPA should make determinations of whether a technology review is necessary on a case bycase basis for each category.

Commenter 0110 stated that section 112( d)( 6) should be more appropriately viewed as a regulatory backstop authority, similar to the case by case " MACT hammer" provisions of section 112( j), to ensure that available advances in technology will be applied in the event EPA fails to issue residual risk standards under section 112( f). The commenter stated that once EPA has established a residual risk standard under section 112( f) that is " acceptable" or " safe" and protective with an " ample margin of safety," then it must find that a separate revision of the MACT standard under section 112( d)( 6) is not necessary.

Response: We agree with the commenters who indicated that a revision is not necessarily required under section 112( d)( 6) even if cancer risks are greater than or equal to 1 in 1 million. For example, it may be the case that a technology review is performed, but no change in the standard results from that review. However, we disagree with the commenters' assertion that the 1 in 1 million risk level should not be used to determine the need for a subsequent technology review under section 112( d)( 6) of the CAA. Section 112( f)( 2) of the CAA sets a cancer risk cutoff of 1 in 1 million for determining whether residual risk standards must be promulgated. If individual cancer risks for the source category fall below 1 in 1 million, no further risk reductions are necessary regardless of the feasibility or costs of those further reductions. In the preamble to the residual risk rule for Coke Ovens, we have applied a similar logic to the need for subsequent technology reviews under section 112( d)( 6). As we stated in the Coke Ovens rule, if the ample margin of safety analysis for a section 112( f) standard shows that the remaining risk for non threshold pollutants falls below 1 in 1 million and for threshold pollutants falls below a similar threshold of safety, then no further revision would be needed, regardless of costs and feasibility, because an ample margin of safety has already been assured.

E. Context of the Residual Risk Program Comment: Commenter 0109 strongly recommended that EPA carefully lay out the context and framework of the residual risk program in the determination for each source category. The commenter stated that this was especially important because of the unique nature of the program compared to other EPA programs with which the public is familiar.

The commenter specifically recommended that EPA mention the two stage regulatory process ( MACT and residual risk) used to control HAP emissions from major stationary sources and to determine whether the MACT technology controls provide an ample margin of safety. The commenter noted that the residual risk program is different from other EPA programs, in 7 that additional controls will be necessary for only some of the listed categories of sources, because in some cases, the cancer risk will be less than the 1 in 1 million trigger, or, if it is greater, EPA may determine that the current emission level provides the public with an ample margin of safety.

The commenter also recommended that EPA put into the proper context the relatively small contribution of major stationary sources to the risks from air toxics about 11 percent in 1999 and expected to be even smaller as sources come into compliance with the latest MACT rules.

Finally, the commenter recommended that EPA present the risks from air toxics in context with the risks from ambient ( criteria) air pollutants to make clear to the public how the air toxics risk estimates are much more conservative and to avoid any misperceptions by the public that the risk estimates for ambient air pollutants are comparable to the risk estimates for air toxics. Without a program of public education on this issue, the commenter indicated the public may incorrectly believe that the ample margin of safety decisions in the residual risk rules are less stringent than EPA knows them to be, resulting in public lawsuits against EPA's decisions or overregulation by EPA to compensate for the gap in public knowledge. The commenter recommended that EPA include preamble language in future EPA decisions describing the criteria it used to determine the ample margin of safety and presenting the incremental risk/ incremental cost approach in the fuller context for the residual risk program.

Response: We agree that it is important to provide context for any residual risk rule. In the preamble of the current rule, we describe the MACT program and its impact on the magnetic tape source category. We also describe our statutory authority and our obligations to assess risks to human health and the environment under section 112( f) of the CAA, as well as the requirement to further regulate categories of sources if any of the estimated individual cancer risks exceed the statutory trigger level of 1 in 1 million.

However, while we agree that, on a national average basis, population risk levels are dominated by the impacts of mobile source emissions, we disagree with the commenter's contention that it is appropriate to draw the general conclusion that all major stationary sources make relatively small contributions to individual risk levels in their neighborhoods. Rather, the risks posed by any individual major stationary source depend upon a number of factors, including emission rates at the source, proximity of exposed populations to the emission source, the specific HAP emitted, local meteorological conditions, and terrain conditions surrounding the source. Therefore, the relative contribution of a particular major stationary source to overall individual risk levels in its vicinity will vary dramatically depending on the local conditions at and around that specific source. This variability is not captured by the national average contribution of major sources to population risk levels mentioned by the commenter.

We agree that our risk assessment for the magnetic tape source category appropriately contains a number of health protective assumptions, resulting in a screening assessment that is designed to overestimate, rather than underestimate, risks. The results demonstrate negligible risks for potential chronic cancer, chronic noncancer, and acute noncancer health endpoints. Also, no significant human health multipathway or ecological risks were identified. Had the 8 resulting risks been determined to be non negligible, a more refined analysis with site specific data would have been conducted. Such an assessment would be more data intensive; however, it would also present a more accurate estimate of risks which could then be used as the basis for regulatory action. However, since the findings of the screening risk assessment for the magnetic tape source category were negative ( i. e., the statutory cancer risk trigger level was not exceeded), it was not necessary to conduct a more refined risk assessment using more site specific data. Since these activities were not relevant to this action, a complete discussion of them in the context of a full discussion of the residual risk program was not deemed necessary or appropriate. The details of our risk assessment can be found in the docket in the memo titled, " Residual Risk Assessment for the Magnetic Tape Manufacturing Source Category."

F. IRIS Data for Acrylonitrile Comment: According to commenter EPA HQ OAR 2003 0161 0111 ( hereafter referred to as commenter 0111), EPA should not have relied on the outdated unit cancer risk value for acrylonitrile contained in EPA's Integrated Risk Information System ( IRIS) in conducting its residual risk assessment of the magnetic tape manufacturing industry. Although EPA concluded that there were no issues to be addressed regarding acrylonitrile because the facility emitting acrylonitrile presented a potential cancer risk of only 1 in 100 million, the commenter stated that it was inappropriate for EPA to use the acrylonitrile value in IRIS in its assessment because EPA was already aware the value was severely out of date. According to the commenter, the IRIS profile itself indicates that there are one or more significant new studies based on a screeninglevel review of the more recent toxicology literature. The commenter also noted that EPA was aware that numerous new studies had been conducted on assessing the cancer risk from acrylonitrile because its staff were briefed on an assessment of those new studies, received copies of the assessment report, and attended a peer review meeting on the report. The commenter also noted that a summary of the cancer assessment was published in October 2005.

Response: We agree that our IRIS assessment for acrylonitrile does not consider studies published after 1991, and we are currently developing an assessment that includes newer information. Our staff reviewed the assessment described ( and funded) by the commenter and concluded that it does not conform with EPA science policy, as per EPA's Guidelines for Carcinogen Risk Assessment ( EPA 630/ P 03 001F), in three ways. First, the assessment concludes that the mode of action is nonlinear, but is unable to identify a nonlinear mechanism. Second, the assessment provides a supplemental linear unit risk value but bases it upon animal data rather than human data. Third, the animal based linear value was not documented adequately for us to confirm the calculations. Therefore, we conclude that the current IRIS assessment represents the best available science at this time.


[Federal Register Volume 76, Number 20 (Monday, January 31, 2011)]
[Proposed Rules]
[Pages 5306-5307]
[FR Doc No: 2011-2069]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2010-1027; Airspace Docket No. 10-AGL-15]

Proposed Amendment of Class E Airspace; Indianapolis Executive
Airport, IN

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend Class E airspace for the
Indianapolis Executive Airport, Indianapolis, IN airspace area.
Controlled airspace is necessary to accommodate new Standard Instrument
Approach Procedures (SIAP) for the Clarian North Medical Center
Heliport, Carmel, IN, and the Methodist Hospital of Indiana Heliport,
Indianapolis, IN. The FAA is taking this action to enhance the safety
and management of Instrument Flight Rules (IFR) operations at the
airport.

DATES: 0901 UTC. Comments must be received on or before March 17, 2011.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue, SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590-0001. You
must identify the docket number FAA-2010-1027/Airspace Docket No. 10-
AGL-15, at the beginning of your comments. You may also submit comments
through the Internet at http://www.regulations.gov. You may review the
public docket containing the proposal, any comments received, and any
final disposition in person in the Dockets Office between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The Docket Office
(telephone 1-800-647-5527), is on the ground floor of the building at
the above address.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone: 817-321-
7716.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2010-1027/
Airspace Docket No. 10-AGL-15.'' The postcard will be date/time stamped
and returned to the commenter.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. An
informal docket may also be examined during normal business hours at
the office of the Central Service Center, 2601 Meacham Blvd., Fort
Worth, TX 76137.
    Persons interested in being placed on a mailing list for future
NPRMs should contact the FAA's Office of Rulemaking<PHONE_NUMBER>, to
request a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    This action proposes to amend Title 14, Code of Federal Regulations
(14 CFR), Part 71 by adding Class E airspace extending upward from 700
feet above the surface for new COPTER RNAV (POINT-IN-SPACE) standard
instrument approach procedures at Clarian North Medical Center
Heliport, Carmel, IN, and Methodist Hospital of Indiana Heliport,
Indianapolis, IN. Controlled airspace is needed for the safety and
management of IFR operations at the heliports.
    Class E airspace areas are published in Paragraph 6005 of FAA Order
7400.9U, dated August 18, 2010, and effective September 15, 2010, which
is incorporated by reference in 14 CFR 71.1. The Class E airspace
designation listed in this document would be published subsequently in
the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) Is not a ``significant regulatory action'' under
Executive

Order 12866; (2) is not a ``significant rule'' under DOT Regulatory
Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does
not warrant preparation of a Regulatory Evaluation as the anticipated
impact is so minimal. Since this is a routine matter that will only
affect air traffic procedures and air navigation, it is certified that
this rule, when promulgated, will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, section 106 describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
subtitle VII, part A, subpart I, section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would add controlled airspace at Clarian North Medical Center
Heliport, Carmel, IN, and Methodist Hospital of Indiana Heliport,
Indianapolis, IN.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

    1. The authority citation for part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of FAA Order
7400.9U, Airspace Designations and Reporting Points, dated August 18,
2010, and effective September 15, 2010, is amended as follows:

Paragraph 6005 Class E Airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

AGL IN E5 Indianapolis Executive Airport, IN [Amended]

Indianapolis, Indianapolis Executive Airport, IN
    (Lat. 40[deg]01'50'' N., long. 86[deg]15'05'' W.)
Carmel, Clarian North Medical Center Heliport, IN Point In Space
    (Lat. 38[deg]56'53'' N., long. 86[deg]09'20'' W.)
Indianapolis, Methodist Hospital of Indiana Heliport, IN Point In
Space
    (Lat. 39[deg]47'00'' N., long. 86[deg]10'27'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.5-mile radius of Indianapolis Executive Airport, and
within a 6-mile radius of the Clarian North Medical Center Heliport
point in space coordinates at lat. 38[deg]56'53'' N., long.
86[deg]09'20'' W., and within a 6-mile radius of the Methodist
Hospital of Indiana Heliport point in space coordinates at lat.
39[deg]47'00'' N., long. 86[deg]10'27'' W., excluding that airspace
within the Indianapolis, IN Class C airspace area.

    Issued in Fort Worth, TX, on January 14, 2011.
Richard J. Kervin, Jr.,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2011-2069 Filed 1-28-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: November 17, 2009 (Volume 74, Number 220)]
[Notices]
[Page 59162-59163]
[DOCID:fr17no09-52]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-SFUND-2004-0008; FRL-8981-7]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; Cooperative Agreements and
Superfund State Contracts for Superfund Response Actions (Renewal); EPA
ICR No. 1487.10, OMB Control No. 2050-0179

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that an Information
Collection Request (ICR) has been forwarded to the Office of Management
and Budget (OMB) for review and approval. This is a request to renew an
existing approved collection. The ICR, which is abstracted below,
describes the nature of the information collection and its estimated
burden and cost.

DATES: Additional comments may be submitted on or before December 17,
2009.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-
SFUND-2004-0008, to (1) EPA online using http://www.regulations.gov
(our preferred method), by email to<EMAIL_ADDRESS>or by
mail to: EPA Docket Center, Environmental Protection Agency, Superfund
Docket, Mailcode: 28221T, 1200 Pennsylvania Ave., NW., Washington, DC
20460, and (2) OMB by mail to: Office of Information and Regulatory
Affairs, Office of Management and Budget (OMB), Attention: Desk Officer
for EPA, 725 17th Street, NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: David Yogi, Office of Solid Waste and
Emergency Response, Assessment and Remediation Division, (5204 P),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(703) 603-9112; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On June 17, 2009 (74 FR 28693), EPA sought comments on this
ICR pursuant to 5 CFR 1320.8(d). EPA received no comments. Any
additional comments on this ICR should be submitted to EPA and OMB
within 30 days of this notice.
    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-SFUND-2004-0008, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the Superfund
Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301
Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room
is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number for the Reading Room is 202-566-
1744, and the telephone number for the Superfund Docket is 202-566-
9744.
    Use EPA's electronic docket and comment system at
www.regulations.gov, to submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov as EPA
receives them and without change, unless the comment contains
copyrighted material, confidential business information (CBI), or other
information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to http://
www.regulations.gov.
    Title: Cooperative Agreements and Superfund State Contracts for
Superfund Response Actions (Renewal).
    ICR numbers: EPA ICR No. 1487.10, OMB Control No. 2050-0179.
    ICR Status: This ICR is scheduled to expire on December 31, 2009.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
An Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information, unless it displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR part 9, are displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers in certain EPA regulations is
consolidated in 40 CFR part 9.
    Abstract: This ICR authorizes the collection of information under
40 CFR part 35, subpart O, which establishes the administrative
requirements for cooperative agreements funded under the Comprehensive
Environmental Response, Compensation, and Liability Act (CERCLA) for
State, federally-recognized Indian tribal governments, intertribal
consortiums, and political subdivision response actions. This
regulation also codifies the administrative requirements for Superfund
State Contracts for non-State lead remedial responses. This regulation
includes only those provisions mandated by CERCLA, required by OMB
Circulars, or added by EPA to ensure sound and effective financial
assistance management under this regulation. The information is
collected from applicants and/or recipients of EPA assistance and is
used to make awards, pay recipients, and collect information on how
federal funds are being utilized. EPA requires this information to meet
its federal stewardship responsibilities. Recipient responses are
required to obtain a benefit (federal funds) under 40 CFR part 31,
``Uniform Administrative Requirements for Grants and Cooperative
Agreements to State and Local Governments'' and under 40 CFR part 35,
``State and Local Assistance.''
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 7
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: State; Local; or Tribal governments.
    Estimated Number of Respondents: 568.
    Frequency of Response: On occasion.
    Estimated Total Annual Hour Burden: 4,189.
    Estimated Total Annual Cost: $128,466.67, includes no costs for
annualized capital or O&M costs.
    Changes in the Estimates: There is a decrease of 884 hours in the
total estimated burden currently identified in the OMB Inventory of
Approved ICR Burdens. This decrease reflects a decrease in the
estimated number of respondents from the previous ICR.

    Dated: November 9, 2009.
John Moses,
Director, Collection Strategies Division.
[FR Doc. E9-27618 Filed 11-16-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: December 8, 2008 (Volume 73, Number 236)]
[Proposed Rules]
[Page 74378-74380]
[DOCID:fr08de08-11]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2008-1162; Airspace Docket No. 08-AAL-33]

Proposed Revision of Class D and E Airspace; King Salmon, AK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking.

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SUMMARY: This action proposes to revise Class D and E airspace at King
Salmon, AK. Nine Standard Instrument Approach Procedures (SIAPs), and a
textual Obstacle Departure Procedure (ODP) are being amended for the
King Salmon Airport at King Salmon, AK. Adoption of this proposal would
result in revision of Class D and E airspace upward from the surface,
and from 700 feet (ft.) and 1,200 ft. above the surface at the King
Salmon Airport, King Salmon, AK.

DATES: Comments must be received on or before January 22, 2009.

ADDRESSES: Send comments on the proposal to the Docket Management
Facility, U.S. Department of Transportation, 1200 New Jersey Avenue,
SE., West Building Ground Floor, Room W12-140, Washington, DC 20590-
0001. You must identify the docket number FAA-2008-1162/Airspace Docket
No. 08-AAL-33, at the beginning of your comments. You may also submit
comments on the Internet at http://www.regulations.gov. You may review
the public docket containing the proposal, any comments received, and
any final disposition in person in the Dockets Office between 9 a.m.
and 5 p.m., Monday through Friday, except Federal holidays. The Docket
Office (telephone 1-800-647-5527) is on the plaza level of the
Department of Transportation NASSIF Building at the above address.
    An informal docket may also be examined during normal business
hours at the office of the Manager, Safety, Alaska Flight Service
Operations, Federal Aviation Administration, 222 West 7th Avenue, Box
14, Anchorage, AK 99513-7587.

FOR FURTHER INFORMATION CONTACT: Gary Rolf, Federal Aviation
Administration, 222 West 7th Avenue, Box 14, Anchorage, AK 99513-7587;
telephone number<PHONE_NUMBER>; fax:<PHONE_NUMBER>; e-mail:
<EMAIL_ADDRESS>Internet address: http://www.faa.gov/about/
office_org/headquarters_offices/ato/service_units/systemops/fs/
alaskan/rulemaking/.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2008-1162/
Airspace Docket No. 08-AAL-33.'' The postcard will be date/time stamped
and returned to the commenter.
    All communications received on or before the specified closing date
for comments will be considered before taking action on the proposed
rule. The proposal contained in this notice may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the closing date
for comments. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of Notice of Proposed Rulemakings (NPRMs)

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://
www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_
amendments/.
    Additionally, any person may obtain a copy of this notice by
submitting a request to the Federal Aviation Administration, Office of
Air Traffic Airspace Management, ATA-400, 800 Independence Avenue, SW.,
Washington, DC 20591 or by calling<PHONE_NUMBER>. Communications must
identify both docket numbers for this notice. Persons interested in
being placed on a mailing list for future NPRMs should contact the
FAA's Office of Rulemaking,<PHONE_NUMBER>, to request a copy of
Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution
System, which describes the application procedure.

The Proposal

    The FAA is considering an amendment to the Code of Federal
Regulations (14 CFR part 71), which would revise Class D and E airspace
at the King Salmon Airport, in King Salmon, AK. The intended effect of
this proposal is to revise Class D and E airspace upward from the
surface, and from 700 ft. and 1,200 ft. above the surface to contain
Instrument Flight Rules (IFR) operations at the King Salmon Airport,
King Salmon, AK.
    The FAA Instrument Flight Procedures Production and Maintenance
Branch has amended nine SIAPs and an ODP for the King Salmon Airport.
The approaches are (1) the Area Navigation (RNAV) Global Positioning
System (GPS) Runway (RWY) 12, Amendment (Amdt) 1; (2) the RNAV (GPS)
RWY 30, Amdt 1; (3) the Localizer (LOC)/Distance Measuring Equipment
(DME) Backcourse RWY 30, Amdt 4; (4) the Instrument Landing System
(ILS) or LOC/DME RWY 12, Amdt 17; (5) the HI ILS or LOC/DME RWY 12,
Amdt 6; (6) the Very High Frequency Omni-directional Range (VOR)/DME or
Tactical Air Navigation (TACAN) RWY 30, Amdt 10; (7) the VOR or TACAN
RWY 12, Amdt 13; (8) the HI VOR/DME or TACAN RWY 12, Amdt 4; and (9)
the HI VOR/DME or TACAN RWY 30, Amdt 4. The Textual ODP is unnamed and
will be published in the front of the U.S. Terminal Procedures for
Alaska. Class E controlled airspace extending upward from the surface,
and from 700 ft. and 1,200 ft. above the surface in the King Salmon
Airport area would be revised by this action. The proposed airspace is
sufficient in size to contain aircraft executing the instrument
procedures at the King Salmon Airport, King Salmon, AK.
    The area would be depicted on aeronautical charts for pilot
reference. The coordinates for this airspace docket are based on North
American Datum 83. The Class D airspace area designations are published
in paragraph 5000 in FAA Order 7400.9S, Airspace Designations and
Reporting Points, signed October 3, 2008, and effective October 31,
2008, which is incorporated by reference in 14 CFR 71.1. The Class E2
surface areas are published in paragraph 6002 in FAA Order 7400.9S,
Airspace Designations and Reporting Points, signed October 3, 2008, and
effective October 31, 2008, which is incorporated by reference in 14
CFR 71.1. The Class E4 surface areas designated as extensions to Class
D surface areas are published in paragraph 6004 in FAA Order 7400.9S,
Airspace Designations and Reporting Points, signed October 3, 2008, and
effective October 31, 2008, which is incorporated by reference in 14
CFR 71.1. The Class E airspace areas designated as 700/1200 foot
transition areas are published in paragraph 6005 in FAA Order 7400.9S,
Airspace Designations and Reporting Points, signed October 3, 2008, and
effective October 31, 2008, which is incorporated by reference in 14
CFR 71.1. The Class D and E airspace designations listed in this
document would be published subsequently in the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore --(1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Because this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle 1, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart 1, Section 40103, Sovereignty and use of
airspace. Under that section, the FAA is charged with prescribing
regulations to ensure the safe and efficient use of the navigable
airspace. This regulation is within the scope of that authority because
it proposes to create Class E airspace sufficient in size to contain
aircraft executing instrument procedures at the King Salmon Airport,

AK, and represents the FAA's continuing effort to safely and
efficiently use the navigable airspace.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, CLASS B, CLASS C, CLASS D, AND
CLASS E AIRSPACE AREAS; AIRWAYS; ROUTES; AND REPORTING POINTS

    1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of Federal
Aviation Administration Order 7400.9S, Airspace Designations and
Reporting Points, signed October 3, 2008, and effective October 31,
2008, is to be amended as follows:
* * * * *

Paragraph 5000 General.

* * * * *

AAL AK D King Salmon, AK [Revised]

King Salmon, King Salmon Airport, AK
    (Lat. 58[deg]40'37'' N., long. 156[deg]38'58'' W.)

    That airspace extending upward from the surface to and including
2,500 feet MSL within a 4.4-mile radius of the King Salmon Airport,
AK. This Class D airspace area is effective during the specific
dates and times established in advance by a Notice to Airmen. The
effective date and time will thereafter be continuously published in
the Airport/Facility Directory.
* * * * *

Paragraph 6002 Class E Airspace Designated as Surface Areas.

* * * * *

AAL AK E2 King Salmon, AK [Revised]

King Salmon, King Salmon Airport, AK
    (Lat. 58[deg]40'37'' N., long. 156[deg]38'58'' W.)

    Within a 4.4-mile radius of the King Salmon Airport, AK. This
Class E airspace area is effective during the specific dates and
times established in advance by a Notice to Airmen. The effective
date and time will thereafter be continuously published in the
Airport/Facility Directory.
* * * * *

Paragraph 6004 Class E Airspace Areas Designated as an Extension to
a Class D Surface Area.

* * * * *

AAL AK E4 King Salmon, AK [Revised]

King Salmon, King Salmon Airport, AK
    (Lat. 58[deg]40'37'' N., long. 156[deg]38'58'' W.)

    That airspace extending upward from the surface within 4 miles
either side of the 312[deg](T)/328[deg](M) bearing from the King
Salmon Airport, AK, to 10.7 miles northwest of the King Salmon
Airport, AK.
* * * * *

Paragraph 6005 Class E Airspace Extending Upward from 700 Feet or
More Above the Surface of the Earth.

* * * * *

AAL AK E5 King Salmon, AK [Revised]

King Salmon, King Salmon Airport, AK
    (Lat. 58[deg]40'37'' N., long. 156[deg]38'58'' W.)

King Salmon VORTAC
    (Lat. 58[deg]43'29'' N., long. 156[deg]45'08'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.9-mile radius of the King Salmon Airport, AK, and within
5 miles north and 9 miles south of the 132[deg](T)/148[deg](M)
radial of the King Salmon VORTAC, AK, extending from the King Salmon
VORTAC, AK, to 36 miles southeast of the King Salmon VORTAC, AK, and
within 3.9 miles either side of the 312[deg](T)/328[deg](M) radial
of the King Salmon VORTAC, AK, extending from the 6.9-mile radius to
13.9 miles northwest of the King Salmon VORTAC, AK; and that
airspace extending upward from 1,200 feet above the surface within a
73-mile radius of the King Salmon Airport, AK.
* * * * *

    Issued in Anchorage, AK, on November 21, 2008.
Marshall G. Severson,
Acting Manager, Alaska Flight Services Information Area Group.
[FR Doc. E8-28978 Filed 12-5-08; 8:45 am]

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[Federal Register Volume 79, Number 115 (Monday, June 16, 2014)]
[Proposed Rules]
[Page 34272]
[FR Doc No: 2014-13854]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 79, No. 115 / Monday, June 16, 2014 /
Proposed Rules

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2014-0413; FRL-9912-04-Region-9]

Revisions to the California State Implementation Plan, Great
Basin Unified Air Pollution Control District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a revision to the Great Basin Unified Air Pollution Control
District (GBUAPCD) portion of the California State Implementation Plan
(SIP). This revision concerns particulate matter (PM) emissions from
agriculture. We are proposing to approve a local rule to regulate this
emission source under the Clean Air Act (CAA or the Act).

DATES: Any comments on this proposal must arrive by July 16, 2014.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2014-0413, by one of the following methods:
    1. Federal eRulemaking Portal: www.regulations.gov. Follow the on-
line instructions.
    2. EMail<EMAIL_ADDRESS>    3. Mail or Deliver: Andrew Steckel (Air-4), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at www.regulations.gov,
including any personal information provided, unless the comment
includes Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Information that you
consider CBI or otherwise protected should be clearly identified as
such and should not be submitted through www.regulations.gov or email.
www.regulations.gov is an ``anonymous access'' system, and EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send email directly to EPA, your email
address will be automatically captured and included as part of the
public comment. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment. Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses.
    Docket: Generally, documents in the docket for this action are
available electronically at www.regulations.gov and in hard copy at EPA
Region IX, 75 Hawthorne Street, San Francisco, California 94105-3901.
While all documents in the docket are listed at www.regulations.gov,
some information may be publicly available only at the hard copy
location (e.g., copyrighted material, large maps), and some may not be
publicly available in either location (e.g., CBI). To inspect the hard
copy materials, please schedule an appointment during normal business
hours with the contact listed in the FOR FURTHER INFORMATION CONTACT
section.

FOR FURTHER INFORMATION CONTACT: Nancy Levin, EPA Region IX, (415) 972-
3848<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This proposal addresses the following local
rule: GBUAPCD Rule 502 Conservation Management Practices. In the Rules
and Regulations section of this Federal Register, we are approving this
local rule in a direct final action without prior proposal because we
believe these SIP revisions are not controversial. If we receive
adverse comments, however, we will publish a timely withdrawal of the
direct final rule and address the comments in subsequent action based
on this proposed rule.
    We do not plan to open a second comment period, so anyone
interested in commenting should do so at this time. If we do not
receive adverse comments, no further activity is planned. For further
information, please see the direct final action.

    Dated: May 30, 2014.
Jared Blumenfeld,
Regional Administrator, Region IX.
[FR Doc. 2014-13854 Filed 6-13-14; 8:45 am]
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