[Federal Register Volume 77, Number 78 (Monday, April 23, 2012)]
[Rules and Regulations]
[Pages 24148-24151]
[FR Doc No: 2012-9705]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2012-0213; FRL-9661-6]

Revision to the Hawaii State Implementation Plan, Minor New
Source Review Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking direct
final action to approve revisions to the Hawaii State Implementation
Plan (SIP). These revisions would update and replace the minor new
source review rules that EPA approved into the Hawaii SIP in 1983.

DATES: This rule is effective on June 22, 2012 without further notice,
unless EPA receives adverse comments by May 23, 2012. If we receive
such comments, we will publish a timely withdrawal in the Federal
Register to notify the public that this direct final rule will not take
effect.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2012-0213, 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: Gerardo Rios (Air-3), 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.
    Docket: The index to the docket for this action is available
electronically at www.regulations.gov and in hard copy at EPA Region
IX, 75 Hawthorne Street, San Francisco, California. While EPA generally
lists the documents in the docket in the index, some information may
not be specifically listed as a line item in the index or may be
publicly available only at the hard copy location (e.g., voluminous
records, copyrighted material), 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. The hard
copy materials constitute the docket.

FOR FURTHER INFORMATION CONTACT: Geoffrey Glass, EPA Region IX, (415)
972-3534<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us,''
and ``our'' refer to EPA.

Table of Contents

I. The State's Submittal
    A. What rules did the State submit?
    B. What rules are being removed from the SIP?
    C. What is the purpose of the submitted rule revisions?
II. EPA's Evaluation and Action
    A. How is EPA evaluating the rules?
    B. Do the rules meet the evaluation criteria?
    C. Public Comment and Final Action
III. Statutory and Executive Order Reviews

I. The State's Submittal

A. What rules did the State submit?

    Table 1 lists the rules we are approving with the dates that they
were adopted by the local air agency and submitted by the Hawaii
Department of Health (HDOH).

                                            Table 1--Submitted Rules
----------------------------------------------------------------------------------------------------------------
             Local agency                  Rule No.               Rule title              Revised     Submitted
----------------------------------------------------------------------------------------------------------------
HDOH..................................       11-60.1-3  General conditions for             11/14/03     12/14/11
                                                         considering applications.
HDOH..................................       11-60.1-5  Permit conditions.............     11/14/03     12/14/11
HDOH..................................       11-60.1-7  Transfer of permit............     11/14/03     12/14/11
HDOH..................................      11-60.1-12  Air quality models............     11/14/03     12/14/11
HDOH..................................      11-60.1-19  Penalties and remedies........     11/14/03     12/14/11
HDOH..................................      11-60.1-81  Definitions...................     11/14/03     12/14/11
HDOH..................................      11-60.1-82  Applicability.................     11/14/03     12/14/11
HDOH..................................      11-60.1-83  Initial covered source permit      11/14/03     12/14/11
                                                         application.
HDOH..................................      11-60.1-84  Duty to supplement or correct      11/14/03     12/14/11
                                                         permit applications.
HDOH..................................      11-60.1-91  Temporary covered source           11/14/03     12/14/11
                                                         permits.
HDOH..................................      11-60.1-92  Covered source general permits     11/14/03     12/14/11
HDOH..................................      11-60.1-93  Federally-enforceable permit       11/14/03     12/14/11
                                                         terms and conditions.
HDOH..................................      11-60.1-99  Public participation..........     11/14/03     12/14/11
HDOH..................................     11-60.1-103  Applications for minor             11/14/03     12/14/11
                                                         modifications.
HDOH..................................     11-60.1-104  Applications for significant       11/14/03     12/14/11
                                                         modifications.
----------------------------------------------------------------------------------------------------------------

    On January 27, 2012, EPA determined that the submittal for Hawaii
Department of Health Chapter 60.1 met the completeness criteria in 40
CFR Part 51 Appendix V, which must be met before formal EPA review.

B. What rules are being removed from the SIP?

    Table 2 lists rules that we had previously approved into the SIP
with the date of adoption by HDOH and the date of publication in the
Federal Register. These rules are superseded by the rules listed in
Table 1.

                                             Table 2--Deleted Rules
----------------------------------------------------------------------------------------------------------------
             Local agency                  Rule No.               Rule title              Adopted     Published
----------------------------------------------------------------------------------------------------------------
HDOH..................................        11-60-02  Permit system, applicability..     11/29/82      8/18/83
HDOH..................................        11-60-03  Permit system, applications...     11/29/82      8/18/83
HDOH..................................        11-60-04  Permit system, conditions for      11/29/82      8/18/83
                                                         considering applications.
HDOH..................................        11-60-05  Permit system, action on           11/29/82      8/18/83
                                                         applications.
HDOH..................................        11-60-07  Permit system, cancellation of     11/29/82      8/18/83
                                                         authority to construct.
HDOH..................................        11-60-08  Permit system, suspension or       11/29/82      8/18/83
                                                         revocation of permit to
                                                         operate.
HDOH..................................        11-60-09  Permit system, transfer of         11/29/82      8/18/83
                                                         permit to operate.
HDOH..................................        11-60-11  Permit system, posting of          11/29/82      8/18/83
                                                         permit to operate.
HDOH..................................        11-60-12  Permit system, fees...........     11/29/82      8/18/83
HDOH..................................        11-60-13  Permit system, fee schedule        11/29/82      8/18/83
                                                         for a permit to operate.
HDOH..................................        11-60-14  Permit system, period of           11/29/82      8/18/83
                                                         permit.
HDOH..................................        11-60-37  Penalties & remedies..........     11/29/82      8/18/83
----------------------------------------------------------------------------------------------------------------

C. What is the purpose of the submitted rule revisions?

    Section 110(a)(2)(C) of the Clean Air Act as amended in 1990 (CAA
or the Act) requires States to include in their SIPs programs that
regulate the construction and modification of stationary sources
adequate to ensure that the national ambient air quality standards are
achieved. The purpose of these revisions is to fulfill this requirement
of the CAA as it applies to minor stationary sources and minor
modifications made to major stationary sources.

II. EPA's Evaluation and Action

A. How is EPA evaluating the rules?

    Generally, SIP rules must be enforceable (see section 110(a) of the
Act), and must not relax existing requirements (see sections 110(l)).
    Specifically, EPA evaluates minor new source review programs
included as a SIP submittal based on the criteria in subpart I of 40
CFR 51, excluding 40 CFR 51.165 and 50.166, which relate to review of
new major sources and major modifications under part C or D of title I
of the CAA.

B. Do the rules meet the evaluation criteria?

    We believe these rules are consistent with the relevant policy and
guidance regarding enforceability and SIP relaxations and meet the
criteria in subpart I of 40 CFR part 51 sections 160-164. The technical
support document has more information on our evaluation.

C. Public Comment and Final Action

    As authorized in section 110(k)(3) of the Act, EPA is fully
approving the submitted rules because we believe they fulfill all
relevant requirements. We do not think anyone will object to this
approval, so we are finalizing it without proposing it in advance.
However, in the Proposed Rules section of this Federal Register, we are
simultaneously proposing approval of the same submitted rules. If we
receive adverse comments by May 23, 2012, we will publish a timely
withdrawal in the Federal Register to notify the public that the direct
final approval will not take effect and we will address the comments in
a subsequent final action based on the proposal. If we do not receive
timely adverse comments, the direct final approval will be effective
without further notice on June 22, 2012. This will incorporate these
rules into the federally enforceable SIP for Hawaii.
    Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment.

III. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act 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 Clean Air Act.
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 disproportionate human health or environmental effects with
practical, appropriate, 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.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a

copy of the rule, to each House of the Congress and to the Comptroller
General of the United States. EPA will submit a report containing this
action and other required information to the U.S. Senate, the U.S.
House of Representatives, and the Comptroller General of the United
States prior to publication of the rule in the Federal Register. A
major rule cannot take effect until 60 days after it is published in
the Federal Register. This action is not a ``major rule'' as defined by
5 U.S.C. 804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by June 22, 2012. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. Parties with objections to this direct final
rule are encouraged to file a comment in response to the parallel
notice of proposed rulemaking for this action published in the Proposed
Rules section of today's Federal Register, rather than file an
immediate petition for judicial review of this direct final rule, so
that EPA can withdraw this direct final rule and address the comment in
the proposed rulemaking. This action may not be challenged later in
proceedings to enforce its requirements (see section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, New source review,
Reporting and recordkeeping requirements.

    Dated: March 20, 2012.
Jared Blumenfeld,
Regional Administrator, Region IX.

    Part 52, Chapter I, Title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for Part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart M--Hawaii

0
2. In Sec.  52.620, the table in paragraph (c) is amended by:
0
a. Removing the following twelve entries under the category for Title
11, Chapter 60: 11-60-2, 11-60-3, 11-60-4, 11-60-5, 11-60-7, 11-60-8,
11-60-9, 11-60-11, 11-60-12, 11-60-13, 11-60-14, and 11-60-37.
0
b. Adding the following fifteen entries in numerical order under the
category for Chapter 60.1: Sections 11-60.1-3, 11-60.1-5, 11-60.1-7,
11-60.1-12, 11-60.1-19, 11-60.1-81, 11-60.1-82, 11-60.1-83, 11-60.1-84,
11-60.1-91, 11-60.1-92, 11-60.1-93, 11-60.1-99, 11-60.1-103, and 11-
60.1-104.
    The additions read as follows:

Sec.  52.620  Identification of plan.

* * * * *
    (c) * * *

                                    EPA-Approved State of Hawaii Regulations
----------------------------------------------------------------------------------------------------------------
         State citation              Title/subject       Effective date    EPA Approval date      Explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Department of Health, Title 11,   Hawaii
 Chapter 60.1, Air Pollution       Administrative
 Control.                          Rules.

                                                  * * * * * * *
11-60.1-3.......................  General conditions   .................  04/23/2012 [Insert  Supersedes 11-60-
                                   for considering                         page number where   04, 11-60-11, 11-
                                   applications.                           the document        60-13, 11-60-14.
                                                                           begins].

                                                  * * * * * * *
11-60.1-5.......................  Permit conditions..  .................  04/23/2012 [Insert  New regulation.
                                                                           page number where
                                                                           the document
                                                                           begins].
11-60.1-7.......................  Transfer of permit.  .................  04/23/2012 [Insert  Supersedes 11-60-
                                                                           page number where   09.
                                                                           the document
                                                                           begins].

                                                  * * * * * * *
11-60.1-12......................  Air quality models.  .................  04/23/2012 [Insert  New regulation.
                                                                           page number where
                                                                           the document
                                                                           begins].

                                                  * * * * * * *
11-60.1-19......................  Penalties and        .................  04/23/2012 [Insert  Supersedes
                                   remedies.                               page number where  11-60-37.
                                                                           the document
                                                                           begins].

                                                  * * * * * * *
11-60.1-81......................  Definitions........  .................  04/23/2012 [Insert  New regulation.
                                                                           page number where
                                                                           the document
                                                                           begins].
11-60.1-82......................  Applicability......  .................  04/23/2012 [Insert  Supersedes 11-60-
                                                                           page number where   02.
                                                                           the document
                                                                           begins].

11-60.1-83......................  Initial covered      .................  04/23/2012 [Insert  Supersedes 11-60-
                                   source permit                           page number where   03, 11-60-05, 11-
                                   application.                            the document        60-07, 11-60-08,
                                                                           begins].            11-60-12.
11-60.1-84......................  Duty to supplement   .................  04/23/2012 [Insert  New regulation.
                                   or correct permit                       page number where
                                   applications.                           the document
                                                                           begins].
11-60.1-91......................  Temporary covered    .................  04/23/2012 [Insert  New regulation.
                                   source permits.                         page number where
                                                                           the document
                                                                           begins].
11-60.1-92......................  Covered source       .................  04/23/2012 [Insert  New regulation.
                                   general permits.                        page number where
                                                                           the document
                                                                           begins].
11-60.1-93......................  Federally-           .................  04/23/2012 [Insert  New regulation.
                                   enforceable permit                      page number where
                                   terms and                               the document
                                   conditions.                             begins].
11-60.1-99......................  Public               .................  04/23/2012 [Insert  New regulation.
                                   participation.                          page number where
                                                                           the document
                                                                           begins].
11-60.1-103.....................  Applications for     .................  04/23/2012 [Insert  New regulation.
                                   minor                                   page number where
                                   modifications.                          the document
                                                                           begins].
11-60.1-104.....................  Applications for     .................  04/23/2012 [Insert  New regulation.
                                   significant                             page number where
                                   modifications.                          the document
                                                                           begins].
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2012-9705 Filed 4-20-12; 8:45 am]
BILLING CODE 6560-50-P


From:
Jones, DonnaLee<EMAIL_ADDRESS>Sent:
Tuesday, January 24, 2023 4:46 PM
To:
Dan Pearson<EMAIL_ADDRESS>Cc:
Tim Rodak<EMAIL_ADDRESS>Coke ICR2<EMAIL_ADDRESS>Subject:
RE: Question on Coke ICR submittal

Mr. Pearson  -  You can leave the TO-13A blanks out of the spreadsheet as long as you include the complete lab report.

Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D243-02)
Research Triangle Park, NC  27711  Tele:<PHONE_NUMBER>  Fax<PHONE_NUMBER>
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Reasonableness never fails to be appreciated."  - anon.

Pronouns - She/Her/Hers
Salutation - Dr./Ms.

From: Dan Pearson<EMAIL_ADDRESS>Sent: Tuesday, January 24, 2023 2:59 PM
To: Jones, DonnaLee<EMAIL_ADDRESS>Cc: Tim Rodak<EMAIL_ADDRESS>Subject: Re: Question on Coke ICR submittal

Hi Dr. Jones,

I have another question on the ICR submission packet.

Because there is no air sampling for the TO13A  blanks, there is no way to report a concentration in ug/m3. The results from the lab are reported as total mass.

Are we required to include TO13A blanks in this format? If so, how should these be reported/annotated?

Dan

On Thu, Jan 19, 2023 at 1:57 PM Dan Pearson<EMAIL_ADDRESS>wrote:
Thank you!

On Thu, Jan 19, 2023 at 1:36 PM Jones, DonnaLee<EMAIL_ADDRESS>wrote:
Hello. I've obtained the answers to your questions from our measurement experts at EPA. See below. Let me know if you have any more questions.
- Column K (Sampling period concentration) This should the as measured value, subject to use of the MDL for BDL values.
- Column M (Lab Reported Concentration for BDL sample) This may be left blank as long as the MDL is used for reporting BDL values, this column is an inadvertent redundant inclusion
From the example data in Row 3, it looks like we can have two different concentrations?  Concentration should not be different, this example was due to a slightly different reporting regimen for the refinery fenceline rule
Do you only need data in Column M for BDL samples? Yes, subject to above response

Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D243-02)
Research Triangle Park, NC  27711  Tele:<PHONE_NUMBER>  Fax<PHONE_NUMBER>
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Reasonableness never fails to be appreciated."  - anon.

Pronouns - She/Her/Hers
Salutation - Dr./Ms.

From: Dan Pearson<EMAIL_ADDRESS>Sent: Thursday, January 19, 2023 10:36 AM
To: Jones, DonnaLee<EMAIL_ADDRESS>Cc: Tim Rodak<EMAIL_ADDRESS>Subject: Question on Coke ICR submittal

Good morning, Dr. Jones.
CleanAir is performing fenceline testing for a few clients as part of the Coke ICR, and I have a question on the data submittal. This is the reporting template for the fenceline ICR data. Will you please clarify exactly what needs to be provided in these columns?
- Column K (Sampling period concentration)
- Column M (Lab Reported Concentration for BDL sample)
From the example data in Row 3, it looks like we can have two different concentrations? Do you only need data in Column M for BDL samples?

Dan
--

Dan Pearson
CleanAir Engineering
O:<PHONE_NUMBER>    M:<PHONE_NUMBER>
E<EMAIL_ADDRESS> W: https://www.cleanair.com/
A: 500 W Wood St, Palatine, IL 60067

<< ANSWER-FUGITIVE-Coke Enc2_Test Results_Company_Facility.xlsx >>


[Federal Register Volume 87, Number 231 (Friday, December 2, 2022)]
[Notices]
[Pages 74142-74143]
[FR Doc No: 2022-26266]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP23-16-000]

Columbia Gas Transmission, LLC; Notice of Request Under Blanket
Authorization and Establishing Intervention and Protest Deadline

    Take notice that on November 18, 2022, Columbia Gas Transmission,
LLC (Columbia), 700 Louisiana Street, Suite 1300, Houston, Texas 77002-
2700, filed in the above referenced docket a prior notice request
pursuant to sections 157.205 and 157.208 of the Federal Energy
Regulatory Commission's regulations under the Natural Gas Act (NGA) and
Transco's blanket certificate issued in Docket No. CP83-76-000.
Columbia is requesting authorization to perform installations and
modifications to enable the in-line inspection (ILI), or pigging, of
its 20-inch-diameter Line D100 (D100 ILI Make Piggable Project), at
various locations in Seneca, Sandusky, and Wood Counties, Ohio. The
estimated cost for the project is approximately $31 million, all as
more fully set forth in the request which is on file with the
Commission and open to public inspection.
    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 (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. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    Any questions concerning this application should be directed to
David A. Alonzo, Manager, Project Authorizations, Columbia Gas
Transmission, LLC, 700 Louisiana Street, Suite 1300, Houston, Texas
77002-2700, phone:<PHONE_NUMBER>, email: [email protected].

Public Participation

    There are three ways to become involved in the Commission's review
of this project: you can file a protest to the project, you can file a
motion to intervene in the proceeding, and you can file comments on the
project. There is no fee or cost for filing protests, motions to
intervene, or comments. The deadline for filing protests, motions to
intervene, and comments is 5:00 p.m. Eastern Time on January 27, 2023.
How to file protests, motions to intervene, and comments is explained
below.

Protests

    Pursuant to section 157.205 of the Commission's regulations under
the NGA,\1\ any person \2\ or the Commission's staff may file a protest
to the request. If no protest is filed within the time allowed or if a
protest is filed and then withdrawn within 30 days after the allowed
time for filing a protest, the proposed activity shall be deemed to be
authorized effective the day after the time allowed for protest. If a
protest is filed and not withdrawn within 30 days after the time
allowed for filing a protest, the instant request for authorization
will be considered by the Commission.
---------------------------------------------------------------------------

    \1\ 18 CFR 157.205.
    \2\ Persons include individuals, organizations, businesses,
municipalities, and other entities. 18 CFR 385.102(d).
---------------------------------------------------------------------------

    Protests must comply with the requirements specified in section
157.205(e) of the Commission's regulations,\3\ and must be submitted by
the protest deadline, which is January 27, 2023. A protest may also
serve as a motion to intervene so long as the protestor states it also
seeks to be an intervenor.
---------------------------------------------------------------------------

    \3\ 18 CFR 157.205(e).
---------------------------------------------------------------------------

Interventions

    Any person has the option to file a motion to intervene in this
proceeding. Only intervenors have the right to request rehearing of
Commission orders issued in this proceeding and to subsequently
challenge the Commission's orders in the U.S. Circuit Courts of Appeal.
    To intervene, you must submit a motion to intervene to the
Commission in accordance with Rule 214 of the Commission's Rules of
Practice and Procedure \4\ and the regulations under the NGA \5\ by the
intervention deadline for the project, which is January 27, 2023. As
described further in Rule 214, your motion to intervene must state, to
the extent known, your position regarding the proceeding, as well as
your interest in the proceeding. For an individual, this could include
your status as a landowner, ratepayer, resident of an impacted
community, or recreationist. You do not need to have property directly
impacted by the project in order to intervene. For more information
about motions to intervene, refer to the FERC website at https://www.ferc.gov/resources/guides/how-to/intervene.asp.
---------------------------------------------------------------------------

    \4\ 18 CFR 385.214.
    \5\ 18 CFR 157.10.
---------------------------------------------------------------------------

    All timely, unopposed motions to intervene are automatically
granted by operation of Rule 214(c)(1). Motions to intervene that are
filed after the intervention deadline are untimely and may be denied.
Any late-filed motion to intervene must show good cause for being late
and must explain why the time limitation should be waived and provide
justification by reference to factors set forth in Rule 214(d) of the
Commission's Rules and Regulations. A person obtaining party status
will be

placed on the service list maintained by the Secretary of the
Commission and will receive copies (paper or electronic) of all
documents filed by the applicant and by all other parties.

Comments

    Any person wishing to comment on the project may do so. The
Commission considers all comments received about the project in
determining the appropriate action to be taken. To ensure that your
comments are timely and properly recorded, please submit your comments
on or before January 27, 2023. The filing of a comment alone will not
serve to make the filer a party to the proceeding. To become a party,
you must intervene in the proceeding.

How To File Protests, Interventions, and Comments

    There are two ways to submit protests, motions to intervene, and
comments. In both instances, please reference the Project docket number
CP23-16-000 in your submission.
    (1) You may file your protest, motion to intervene, and comments by
using the Commission's eFiling feature, which is located on the
Commission's website (www.ferc.gov) under the link to Documents and
Filings. New eFiling users must first create an account by clicking on
``eRegister.'' You will be asked to select the type of filing you are
making; first select General'' and then select ``Protest'',
``Intervention'', or ``Comment on a Filing''; or \6\
---------------------------------------------------------------------------

    \6\ Additionally, you may file your comments electronically by
using the eComment feature, which is located on the Commission's
website at www.ferc.gov under the link to Documents and Filings.
Using eComment is an easy method for interested persons to submit
brief, text-only comments on a project.
---------------------------------------------------------------------------

    (2) You can file a paper copy of your submission by mailing it to
the address below. Your submission must reference the Project docket
number CP23-16-000.
    To file via USPS: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426.
    To file via any other method: Kimberly D. Bose, Secretary, Federal
Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland
20852.
    The Commission encourages electronic filing of submissions (option
1 above) and has eFiling staff available to assist you at (202) 502-
8258 or [email protected]
    Protests and motions to intervene must be served on the applicant
either by mail or email (with a link to the document) at: 700 Louisiana
Street, Suite 1300, Houston, Texas 77002-2700 or
[email protected]. Any subsequent submissions by an intervenor
must be served on the applicant and all other parties to the
proceeding. Contact information for parties can be downloaded from the
service list at the eService link on FERC Online.

Tracking the Proceeding

    Throughout the proceeding, additional information about the project
will be available from the Commission's Office of External Affairs, at
(866) 208-FERC, or on the FERC website at www.ferc.gov using the
``eLibrary'' link as described above. The eLibrary link also provides
access to the texts of all formal documents issued by the Commission,
such as orders, notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. For more information and to register, go to
www.ferc.gov/docs-filing/esubscription.asp.

    Dated: November 28, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-26266 Filed 12-1-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: May 21, 2008 (Volume 73, Number 99)]
[Notices]
[Page 29499-29500]
[DOCID:fr21my08-44]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12622-001]

Black River Felts Mills LLC; Notice of Intent To File License
Application, Filing of Pre-Application Document, and Approving Use of
the Traditional Licensing Process

May 14, 2008.
    a. Type of Filing: Notice of Intent to File License Application and
Request to Use the Traditional Licensing Process.
    b. Project No.: 12622-001.
    c. Date Filed: April 2, 2008.
    d. Submitted By: Black River Felts Mills LLC.
    e. Name of Project: Felts Mills Hydroelectric Project.
    f. Location: On the Black River, in Jefferson County, New York. No
federal lands would be occupied by the project works.
    g. Filed Pursuant to: 18 CFR 5.3 of the Commission's regulations.
    h. Potential Applicant Contact: Keith Silliman, Black River Felts
Mills, LLC, c/o Brookfield Power U.S. Holdings America Co., 225
Greenway Parkway, Suite 201, Liverpool, NY 13088;<PHONE_NUMBER>; e-
<EMAIL_ADDRESS>    i. FERC Contact: John Costello at<PHONE_NUMBER>; or e-mail at
<EMAIL_ADDRESS>    j. Black River Felts Mills LLC filed its request to use the
Traditional Licensing Process on April 2, 2008. Black River Felts Mills
LLC provided public notice of its request on April 8, 2008. In a letter
dated May 13, 2008, the Director of the Office of Energy Projects
approved Black River Felts Mills LLC request to use the Traditional
Licensing Process.
    k. With this notice, we are initiating informal consultation with:
(a) The U.S. Fish and Wildlife Service under section 7 of the
Endangered Species Act and the joint agency regulations thereunder at
50 CFR, part 402; (b) NOAA Fisheries under section 305(b) of the
Magnuson-Stevens Fishery Conservation and Management Act and
implementing regulations at 50 CFR 600.920; and (c) the New York State
Historic Preservation Officer, as required by Section 106, National
Historical Preservation Act, and the implementing regulations of the
Advisory Council on Historic Preservation at 36 CFR 800.2.
    l. With this notice, we are designating Black River Felts Mills LLC
as the Commission's non-federal representative for carrying out
informal consultation, pursuant to section 7 of the Endangered Species
Act, section 305

of the Magnuson-Stevens Fishery Conservation and Management Act, and
section 106 of the National Historic Preservation Act.
    m. Black River Felts Mills LLC filed a Pre-Application Document
(PAD; including a proposed process plan and schedule) with the
Commission, pursuant to 18 CFR 5.6 of the Commission's regulations.
    n. A copy of the PAD is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's Web site
(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. A copy is also available for inspection and
reproduction at the address in paragraph h.
    o. Register online at http://ferc.gov/esubscribenow.htm to be
notified via e-mail of new filing and issuances related to this or
other pending projects. For assistance, contact FERC Online Support.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-11333 Filed 5-20-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 22 (Wednesday, February 3, 2016)]
[Notices]
[Pages 5762-5763]
[FR Doc No: 2016-01887]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0469]

Applying Human Factors and Usability Engineering to Medical
Devices; Guidance for Industry and Food and Drug Administration Staff;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Applying Human Factors and
Usability Engineering to Medical Devices.'' FDA has developed this
guidance document to assist industry in following appropriate human
factors and usability engineering processes to maximize the likelihood
that new medical devices will be safe and effective for the intended
users, uses, and use environments. The recommendations in this guidance
document are intended to support manufacturers in improving the design
of medical devices to minimize potential use errors and resulting harm.
FDA believes that these recommendations will enable manufacturers to
assess and reduce risks associated with medical device use.

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2011-D-0469 for ``Applying Human Factors and Usability Engineering
to Medical Devices.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Applying Human Factors and Usability Engineering to Medical Devices''
to the Office of the Center Director, Guidance and Policy

Development, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Shannon Hoste, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2531, Silver Spring, MD 20993-0002,<PHONE_NUMBER> or
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    To understand use-related hazards, it is necessary to have an
accurate and complete understanding of how a device will be used.
Understanding and optimizing how people interact with technology is the
subject of human factors engineering (HFE) and usability engineering
(UE). HFE/UE considerations in the development of medical devices
include the three major components of the device user system: (1)
Device users; (2) device use environments; and (3) device user
interfaces.
    For safety-critical technologies such as medical devices, the
process of eliminating or reducing design-related use problems that
contribute to or cause unsafe or ineffective medical treatment is part
of a process for controlling overall risk. For devices where harm could
result from ``use errors,'' the dynamics of user interaction should be
included in risk analysis and risk management. By incorporating these
considerations into the device development process, manufacturers can
reduce the overall risk level posed by their devices, thus decreasing
adverse events associated with the device and avoiding potential device
recalls.
    In the Federal Register of June 22, 2011 (76 FR 36543), FDA
announced the availability of the draft guidance document. Interested
persons were invited to comment by September 19, 2011. FDA received
over 600 comments, which were generally supportive of the draft
guidance document, but requested clarification in a number of areas.
The most frequent types of comments requested revisions to the language
or structure of the document, or clarification on risk mitigation and
human factors testing methods, user populations for testing, training
of test participants, determining the appropriate sample size in human
factors testing, reporting of testing results in premarket submissions,
and collecting human factors data as part of a clinical study. In
response to these comments, FDA revised the guidance document to
clarify the points identified and restructured the information for
better readability and comprehension. This guidance supersedes the
guidance entitled ``Medical Device Use-Safety: Incorporating Human
Factors Engineering into Risk Management'' dated July 18, 2000, which
will be withdrawn.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Applying Human Factors and Usability
Engineering to Medical Devices.'' It does not establish any rights for
any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the Internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. Persons
unable to download an electronic copy of ``Applying Human Factors and
Usability Engineering to Medical Devices'' may send an email request to
<EMAIL_ADDRESS>to receive an electronic copy of the
document. Please use the document number 1747 to identify the guidance
you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations and guidance. These collections of
information are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 820 are approved
under OMB control number 0910-0073; the collections of information in
21 CFR part 812 are approved under OMB control number 0910-0078; the
collections of information in 21 CFR part 807, subpart E are approved
under OMB control number 0910-0120; the collections of information in
21 CFR part 814, subparts A through E are approved under OMB control
number 0910-0231; the collections of information in 21 CFR part 814,
subpart H are approved under OMB control number 0910-0332; the
collections of information in 21 CFR parts 801 and 809 are approved
under OMB control number 0910-0485; and the collections of information
in the guidance document entitled ``Requests for Feedback on Medical
Device Submissions: The Pre-Submission Program and Meetings with Food
and Drug Administration Staff'' are approved under OMB control number
0910-0756.

    Dated: January 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01887 Filed 2-2-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 5 (Monday, January 9, 2017)]
[Rules and Regulations]
[Page 2193]
[FR Doc No: C1-2016-28714]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Parts 1, 23, 25, 27, 29, 61, 91, 121, 125, and 135

[Docket No.: FAA-2013-0485; Amdt. Nos. 1-70, 23-63, 25-144, 27-48, 29-
56, 61-139, 91-345, 121-376, 125-66, and 135-135]
RIN 2120-AJ94

Revisions to Operational Requirements for the Use of Enhanced
Flight Vision Systems (EFVS) and to Pilot Compartment View Requirements
for Vision Systems

Correction

    In rule document 2016-28714 appearing on pages 90126-90177 in the
issue of Tuesday, December 13, 2016, make the following correction:

0
On page 90174, in the third column, in the 18th through 22nd line,
paragraph (iii) should read

Sec.  91.176(b)(3)(iii)  [Corrected]

    ``(iii) At 100 feet above the touchdown zone elevation of the
runway of intended landing and below that altitude, the flight
visibility must be sufficient for one of the following visual
references to be distinctly visible and identifiable to the pilot
without reliance on the EFVS--''

[FR Doc. C1-2016-28714 Filed 1-6-17; 8:45 am]
 BILLING CODE 1301-00-D