[Federal Register Volume 87, Number 245 (Thursday, December 22, 2022)]
[Notices]
[Page 78679]
[FR Doc No: 2022-27853]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER23-646-000]

Wagon Wheel Wind Project Holdings LLC; Supplemental Notice That
Initial Market-Based Rate Filing Includes Request for Blanket Section
204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
Wagon Wheel Wind Project Holdings LLC's application for market-based
rate authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is January 5, 2023.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    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://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>.

    Dated: December 16, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-27853 Filed 12-21-22; 8:45 am]
BILLING CODE 6717-01-P


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency s Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement, and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request 2. OMB control number b. X None EPA, Office of Air and Radiation, OAQPS a.   2 0 6 0 3. Type of information collection ( check one) 4. Type of review requested ( check one)

a. x New collection a. x Regular b. Revision of a currently approved collection b. Emergency  Approval requested by: / /

c. Extension of a currently approved collection c. Delegated d. Reinstatement, without change, of a previously 5. Small entities approved collection for which approval has expired Will this information collection have a significant economic impact on a e. Reinstatement, with change, of a previously substantial number of small entities? Yes x No approved collection for which approval has expired f. Existing collection in use without OMB control 6. Requested expiration date number a. x Three years from approval date For b   f, note Item A2 of Supporting Statement Instructions b. Other Specify: /

7. Title NESHAP for Coal and Oil Fired Electric Utility Steam Generating Units ( Proposed Rule) ( 40 CFR part 63, subpart UUUUU)

8. Agency form number( s) ( if applicable)

2137.01 9. Keywords Environmental protection, Air pollution control, Hazardous substances, Reporting and recordkeeping requirements, Electric utility steam generating units 10. Abstract Owners and operators performing certain types of site remediations would comply with the recordkeeping and reporting requirements of the NESHAP ( 40 CFR Part 63, Subpart A) and maintain records of specific information needed by EPA to determine if compliance has been achieved.

11. Affected public 12. Obligation to respond ( Mark primary with   P  and all others that apply with   X ) ( Mark primary with   P  and all others that apply with   X )

a. Individuals or households d. Farms a. Voluntary b. P Business or other for profit e. Federal Government b. Required to obtain or retain benefits c. Not for profit institutions f. State, Local or Tribal c. P Mandatory Government 13. Annual reporting and recordkeeping hour burden 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Number of respondents 1 a. Total annualized capital/ startup costs $ 1 b. Total annual responses 1 b. Total annual costs ( O& M) $ 1 1. Percentage of these responses c. Total annualized cost requested $ 2 collected electronically 0 % d. Current OMB inventory $ 0 c. Total annual hours requested 1 e. Difference $ 2 d. Current OMB inventory 0 f. Explanation of difference e. Difference 1 1. Program change $ 2 f. Explanation of difference 2. Adjustment $ 0 1. Program change 1 2. Adjustment 0 15. Purpose of information collection 16. Frequency of recordkeeping or reporting ( check all that apply)

( Mark primary with   P  and all others that apply with   X ) a. X Recordkeeping b. Third party disclosure a. Application for benefits e. Program planning or c. X Reporting b. Program evaluation management 1. X On occasion 2. Weekly c. General purpose statistics f. Research 3. X Monthly 4. Quarterly d. Audit g. P Regulatory or 5. X Semi annually 6. Annually compliance 7. Biennially 8. Other ( describe) daily 17. Statistical methods 18. Agency contact ( person who can best answer questions regarding the Does this information collection employ statistical methods? content of this submission)

Yes X No Name: Bill Maxwell, EPA/ OAR/ OAQPS/ ESD Phone: 919 541 5430 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers: ( a) It is necessary for the proper performance of agency functions; ( b) It avoids unnecessary duplication; ( c) It reduces burden on small entities; ( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents; ( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices; ( f) It indicates the retention periods for recordkeeping requirements; ( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( i) Why the information is being collected; ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number; ( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions); ( i) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Office Official Date Signature of Senior Official or designee Date Acting Director, Collection Strategies Division OMB 83 I 10/ 95 1


[Federal Register Volume 86, Number 77 (Friday, April 23, 2021)]
[Notices]
[Page 21730]
[FR Doc No: 2021-08491]

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ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9056-2]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or https://www.epa.gov/nepa.

Weekly receipt of Environmental Impact Statements (EIS)
Filed April 12, 2021 10 a.m. EST Through April 19, 2021 10 a.m. EST
Pursuant to 40 CFR 1506.9.

    Notice: Section 309(a) of the Clean Air Act requires that EPA make
public its comments on EISs issued by other Federal agencies. EPA's
comment letters on EISs are available at: https://cdxnodengn.epa.gov/cdx-enepa-public/action/eis/search.

EIS No. 20210041, Draft Supplement, CHSRA, CA, California High-Speed
Rail San Jose to Merced Project Section Revised Draft Environmental
Impact Report/Supplemental Draft Environmental Impact Statement,
Comment Period Ends: 06/07/2021, Contact: Scott Rothenberg 916-403-
6936.
EIS No. 20210042, Draft Supplement, FHWA, NH, Newington-Dover, General
Sullivan Bridge Spaulding Turnpike Improvements Project, Comment Period
Ends: 06/07/2021, Contact: Jamie Sikora<PHONE_NUMBER>.

Amended Notice

EIS No. 20210025, Draft, USACE, LA, Proposed Mid-Barataria Sediment
Diversion Project in Plaquemines Parish, Louisiana, Comment Period
Ends: 06/03/2021, Contact: Brad Laborde<PHONE_NUMBER>. Revision to FR
Notice Published 03/05/2021; Extending the Comment Period from 05/04/
2021 to 06/03/2021.

    Dated: April 19, 2021.
Cindy S. Barger,
Director, NEPA Compliance Division, Office of Federal Activities.
[FR Doc. 2021-08491 Filed 4-22-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 177 (Tuesday, September 13, 2016)]
[Rules and Regulations]
[Pages 62813-62817]
[FR Doc No: 2016-21326]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R02-OAR-2016-0060; FRL-9945-84-Region 2]

Approval of Air Quality Implementation Plans; Puerto Rico;
Infrastructure Requirements for the 1997 and 2008 Ozone, 1997 and 2006
Fine Particulate Matter and 2008 Lead NAAQS

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving most
elements of the five State Implementation Plan (SIP) revision
submittals from the Commonwealth of Puerto Rico to demonstrate that the
State meets the requirements of section 110(a)(1) and (2) of the Clean
Air Act (CAA) for the 1997 and 2008 ozone, 1997 and 2006 fine
particulate matter (PM2.5) and 2008 lead National Ambient
Air Quality Standards (NAAQS). The SIP is required to address basic
program elements, including, but not limited to: Regulatory structure,
monitoring, modeling, legal authority, and adequate resources necessary
to assure attainment and maintenance of the standards.

These elements are referred to as infrastructure requirements. In this
rulemaking action, EPA is approving, in accordance with the
requirements of the CAA, the infrastructure SIP submissions with the
exception of some portions of the submittals addressing Prevention of
Significant Deterioration (PSD).

DATES: This rule is effective on October 13, 2016.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R02-OAR-2016-0060. All documents in the docket are listed on
the www.regulations.gov Web site. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available electronically through www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Raymond K. Forde, Air Programs Branch,
Environmental Protection Agency, 290 Broadway, 25th Floor, New York,
New York 10007-1866,<PHONE_NUMBER>, or by email at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The SUPPLEMENTARY INFORMATION section is
arranged as follows:

Table of Contents

I. What is the background information?
II. What comments did EPA receive in response to its proposal?
III. What action is EPA taking?
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. What is the background information?

    On July 18, 1997, the Environmental Protection Agency (EPA)
promulgated a revised national ambient air quality standard (NAAQS or
standards) for ozone (62 FR 38856) and a new NAAQS for fine particle
matter (PM2.5) (62 FR 38652). The revised ozone NAAQS was
based on 8-hour average concentrations. The 8-hour averaging period
replaced the previous 1-hour averaging period, and the level of the
NAAQS was changed from 0.12 parts per million (ppm) to 0.08 ppm. The
new PM2.5 NAAQS established a health-based annual standard
of 15.0 micrograms per cubic meter ([mu]g/m\3\) based on a 3-year
average of annual mean PM2.5 concentrations, and a 24-hour
standard of 65 [mu]g/m\3\ based on a 3-year average of the 98th
percentile of 24-hour concentrations.
    On October 17, 2006 (71 FR 61144), effective December 18, 2006, EPA
revised the 24-hour average PM2.5 primary and secondary
NAAQS from 65 [mu]g/m\3\ to 35 [mu]g/m\3\. As required by section
110(a)(1) of the CAA, the 110(a)(2) submittals were due within three
years after promulgation of the revised standard.
    On March 27, 2008 (73 FR 16436) EPA strengthened its NAAQS for
ground-level ozone, revising the 8-hour primary ozone standard to 0.075
ppm. EPA also strengthened the secondary 8-hour ozone standard to the
level of 0.075 ppm making it identical to the revised primary standard.
    On November 12, 2008 (73 FR 66964), EPA promulgated a revised NAAQS
for lead. The Agency revised the level of the primary lead standard
from 1.5 [mu]g/m\3\ to 0.15 [mu]g/m\3\. The EPA also revised the
secondary NAAQS to 0.15 [mu]g/m\3\ and made it identical to the revised
primary standard.
    Pursuant to section 110(a)(1) of the CAA, states are required to
submit SIPs meeting the applicable requirements of section 110(a)(2)
within three years after promulgation of a new or revised NAAQS or
within such shorter period as EPA may prescribe. Section 110(a)(2)
requires states to address basic SIP elements such as requirements for
monitoring, basic program requirements, and legal authority that are
designed to assure attainment and maintenance of the NAAQS. Section
110(a) imposes the obligation upon states to make a SIP submission to
EPA for a new or revised NAAQS, but the contents of that submission may
vary depending upon the facts and circumstances. In particular, the
data and analytical tools available at the time the state develops and
submits the SIP for a new or revised NAAQS affect the content of the
submission. The content of such SIP submission may also vary depending
upon what provisions the state's existing SIP already contains.
    More specifically, section 110(a)(1) provides the procedural and
timing requirements for SIPs. Section 110(a)(2) lists specific elements
that states must meet for ``infrastructure'' SIP requirements related
to a newly established or revised NAAQS. As mentioned earlier, these
requirements include basic SIP elements such as requirements for
monitoring, basic program requirements, and legal authority that are
designed to assure attainment and maintenance of the NAAQS.
    EPA is acting on five SIP revision submittals from the Commonwealth
of Puerto Rico Environmental Quality Board (PREQB) to satisfy the
requirements of section 110(a)(2) of the CAA for the 1997 and 2008
ozone, 1997 and 2006 PM2.5 and 2008 lead NAAQS. On November
29, 2006, PREQB submitted SIP revisions addressing the infrastructure
requirements for the 1997 ozone and PM2.5 NAAQS. On January
22, 2013, PREQB submitted SIP revisions addressing the infrastructure
requirements for the 2006 PM2.5 and 2008 ozone NAAQS. On
January 31, 2013, PREQB submitted SIP revisions addressing the
infrastructure requirements for the 2008 lead NAAQS. On April 16, 2015,
PREQB supplemented the January 22, 2013 submittal for the 2006
PM2.5 NAAQS. On February 1, 2016, PREQB submitted additional
provisions for inclusion into the SIP which address infrastructure SIP
requirements for 1997 and 2008 ozone, 1997 and 2006 PM2.5
and 2008 lead NAAQS. Each of the infrastructure SIP submittals
addressed the following infrastructure elements for the applicable
NAAQS which EPA is approving pursuant to section 110(a)(2) of the CAA.
Specifically sections 110(a)(2)(A), (B), portions of (C), portions of
(D), (E), (F), (G), (H), portions of (J), (K), (L), and (M) for the
1997 and 2008 ozone, 1997 and 2006 PM2.5 and 2008 lead
NAAQS.

II. What comments did EPA receive in response to its proposal?

    In response to EPA's proposed approval of Puerto Rico's SIP
revision, a comment was received from one interested party. The comment
and EPA's response are as follows:

Comment

    The comment asserts that the proposed rule is confusing and hard to
follow. The comment states that PREQB made 5 revisions over the past 11
or so years and that the last public meetings were 5 years ago. The
comment states that this piecemeal approach is not useful for the
public to follow and that EPA's explanation about why it is justified
in accepting this approach is hard to understand. Commentor notes that
the examples of New Mexico and Tennessee cover much shorter timeframes.
Commentor states that the purpose of the current SIP is to show PREQB
can implement, enforce and maintain the NAAQS covered by the SIP and
asks how have they proven this. The comment references a newspaper
article and states that the Puerto Rico Electric Power Authority
(PREPA) is the main polluter on the island and that it is embroiled in
scandal related to burning substandard fuel that calls into question
the records submitted and the roles of PREQB and USEPA. Commentor

asserts that it is not clear the PREQB is capable of enforcing the SIP
and protecting our air and health of our citizens.

Response

    EPA disagrees that PREQB is taking a piecemeal approach to revising
the SIP. Under CAA sections 110(a)(1) and 110(a)(2), each state is
required to submit a SIP that provides for the implementation,
maintenance, and enforcement of each primary and secondary NAAQS.
Moreover, CAA sections 110(a)(1) and 110(a)(2) require each state to
make this new SIP submission within 3 years after promulgation of a new
or revised NAAQS. In addition, EPA is proposing action on these SIP
revisions simultaneously, and not separately, since each SIP revision
addresses the infrastructure requirements of the CAA. PREQB provided
the necessary public notice and public hearings for each SIP revision
as required by the CAA. Public hearings were held by PREQB for the lead
infrastructure SIP on October 10, 2011. Public hearings were held by
PREQB for the ozone and PM2.5 infrastructure SIPs on
December 19, 2011. With respect to public hearings, EPA's proposed
approval is not based on how many public meetings PREQB holds, or how
long ago the last one was held. Rather EPA's proposed approval is
based, in part, on PREQB's ability to hold a public hearing on each
revision to the SIP.
    The proposed timeframes for other state SIP actions have no bearing
on EPA's proposed approval of Puerto Rico's SIP submittal. Footnote 4
of the proposal cites New Mexico SIP actions as an example in support
of EPA's statement, in the proposal, ``If states elect to make such
multiple SIP submissions to meet the infrastructure SIP requirements,
EPA can elect to act on such submissions either individually or in a
larger combined action.'' 81 FR 8457. Similarly, footnote 5 of the
proposal cites Tennessee SIP actions as an example in support of EPA's
statement in the proposal that, ``EPA interprets the CAA to allow it to
take action on the individual parts of one larger, comprehensive
infrastructure SIP submission for a given NAAQS without concurrent
action on the entire submission. For example, EPA has sometimes elected
to act at different times on various elements and sub-elements of the
same infrastructure SIP submittal.'' 81 FR 8457.
    Commentor is referred to the technical support document (TSD) in
the docket for this matter which describes in detail PREQB's procedures
for implementing, enforcing and maintaining the NAAQS. EPA's proposed
approval is based on PREQB having these procedures in place. Finally,
EPA is not a party to and cannot comment on the ongoing litigation that
the Commentor cites with respect to PREPA.

III. What action is EPA taking?

    EPA is approving Puerto Rico's infrastructure submittals dated
November 29, 2006, January 22, 2013 and January 31, 2013, and
supplemented April 16, 2015 and February 1, 2016, for the 1997 ozone
and PM2.5, 2008 ozone and 2006 PM2.5, and 2008
lead NAAQS, respectively, as meeting the requirements of section
110(a)(2) of the CAA, including specifically section 110(a)(2)(A), (B),
(C)(with the exception of program requirements for PSD), (D)(i)(II)
(with the exception of program requirements related to PSD), (D)(ii)
(with the exception of program requirements related to PSD), (E), (F),
(G), (H), (J) (with the exception of program requirements related to
PSD), (K), (L), and (M).
    EPA is incorporating by reference Act 416 (Commonwealth of Puerto
Rico's ``Environmental Public Policy Act''), Title II, ``On the
Environmental Board,'' Section 7, ``Creating the Board; Members;
Terms,'' sections A. and D., approved September 22, 2004 and effective
six months after its approval and Act 1 (``Puerto Rico Government
Ethics Act of 2011''), Chapter V, ``Financial Reports,'' (approved
January 3, 2012 and effective January 1, 2012, except for Sections
5.5(a) and 5.8(a), which became effective 180 days after the effective
date), for inclusion into Puerto Rico's SIP. These provisions are
intended to apply to any person subject to CAA section 128, and are
included in the SIP to address the requirements of CAA sections
110(a)(2)(E)(ii) and 128 for the 1997 ozone, 1997 PM2.5,
2006 PM2.5, 2008 lead, and 2008 ozone NAAQS.
    EPA is disapproving the following infrastructure SIP requirements
as they relate to the PSD program because Puerto Rico lacks a State
adopted PSD rule to satisfy CAA sections 110(a)(2)(C), (D)(i)(II),
(D)(ii) and (J) for the 1997 and 2008 ozone NAAQS, 1997 and 2006
PM2.5 NAAQS, and 2008 lead NAAQS. It should be noted that a
Federal Implementation Plan (FIP) clock will not be started because a
PSD FIP is currently in place, and sanctions will not be triggered.
Since Puerto Rico is not required to address the visibility portion of
section 110(a)(2)(J) in the context of an infrastructure SIP, and
therefore did not make a submission, action on this sub-element is not
applicable.
    A detailed analysis of EPA's review and rationale for approving and
disapproving elements of the infrastructure SIP submittals as
addressing these CAA requirements may be found in the February 19, 2016
proposed rulemaking action (81 FR 8455) and Technical Support Document
(TSD) which are available on line at www.regulations.gov, Docket ID
Number EPA-R02-OAR-2016-0060.

IV. Incorporation by Reference

    In this rule, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, the EPA is finalizing the incorporation by reference of the
Commonwealth of Puerto Rico Statutes described in the proposed
amemdments to 40 CFR part 52 set forth below.
    EPA is incorporating by reference Act 416 (Commonwealth of Puerto
Rico's ``Environmental Public Policy Act''), Title II, ``On the
Environmental Board,'' Section 7, ``Creating the Board; Members;
Terms,'' sections A. and D., approved September 22, 2004, and Act 1
(``Puerto Rico Government Ethics Act of 2011''), Chapter V, ``Financial
Reports,'' approved January 3, 2012, for inclusion into Puerto Rico's
SIP to address the requirements of CAA sections 110(a)(2)(E)(ii) and
128.
    The EPA has made, and will continue to make, these documents
generally available electronically through http://www.regulations (see
the FOR FURTHER INFORMATION CONTACT section of this preamble for more
information).

V. Statutory and Executive Order Reviews

    Under the CAA, 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 CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    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 CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by November 14, 2016. 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. 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, Incorporation by
reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone,
Particulate matter, Reporting and recordkeeping requirements, Sulfur
oxides, Volatile organic compounds.

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

    Dated: May 2, 2016.
Judith A. Enck,
Regional Administrator, Region 2.

    Editorial Note: This document was received for publication by
the Office of the Federal Register on August 31, 2016.

    For the reasons set forth in the preamble, the Environmental
Protection Agency amends part 52 of chapter I, title 40 of the Code of
Federal Regulations as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart BBB--Puerto Rico

0
2. Section 52.2720 is amended by adding paragraph (c)(39) to read as
follows:

Sec.  52.2720  Identification of plan.

* * * * *
    (c) * * *
    (39) Revisions to the State Implementation Plan submitted by the
Puerto Rico Environmental Quality Board (EQB) on November 29, 2006, and
supplemented February 1, 2016 for the 1997 ozone and PM2.5
NAAQS; dated January 22, 2013, and supplemented April 16, 2015 and
February 1, 2016 for the 2006 PM2.5 and supplemented
February 1, 2016 for the 2008 ozone NAAQS; and dated January 31, 2013
and supplemented February 1, 2016 for the 2008 lead NAAQS.
    (i) Incorporation by reference. These provisions are intended to
apply to any person subject to CAA section 128, and are included in the
SIP to address the requirements of CAA sections 110(a)(2)(E)(ii) and
128.
    (A) Act 416 (Commonwealth of Puerto Rico's ``Environmental Public
Policy Act''), Title II, ``On the Environmental Board,'' Section 7,
``Creating the Board; Members; Terms,'' sections A. and D., approved
September 22, 2004;
    (B) Act 1 (``Puerto Rico Government Ethics Act of 2011''), Chapter
V, ``Financial Reports,'' approved January 3, 2012.

0
3. Amend Sec.  52.2723 by revising the section heading and the title of
the table and adding a heading and the entries ``Act 1'' and ``Act
416'' at the end of the table to read as follows:

Sec.  52.2723  EPA-approved Puerto Rico regulations and laws.

                    Regulation for the Control of Atmospheric Pollution and Puerto Rico Laws
----------------------------------------------------------------------------------------------------------------
     Puerto Rico regulation       Commonwealth effective date         EPA approval date             Comments
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                                PUERTO RICO LAWS
----------------------------------------------------------------------------------------------------------------
Act 1 (``Puerto Rico Government  January 3, 2012..............  September 13, 2016, [insert    These provisions
 Ethics Act of 2011''), Chapter                                  Federal Register citation].    are intended to
 V, ``Financial Reports''.                                                                      apply to any
                                                                                person subject
                                                                                to Clean Air Act
                                                                                section 128, and
                                                                                are included in
                                                                                the SIP for the
                                                                                limited purpose
                                                                                of satisfying
                                                                                the requirements
                                                                                of Clean Air Act
                                                                                sections
                                                                                110(a)(2)(E)(ii)
                                                                                and 128. January
                                                                                3, 2012 is the
                                                                                Commonwealth
                                                                                approval date.
Act 416 (Commonwealth of Puerto  September 22, 2004...........  September 13, 2016, [insert    These provisions
 Rico's ``Environmental Public                                   Federal Register citation].    are intended to
 Policy Act''), Title II, ``On                                                                  apply to any
 the Environmental Board,''                                                                     person subject
 Section 7, ``Creating the                                                                      to Clean Air Act
 Board; Members; Terms,''                                                                       section 128, and
 sections A. and D.                                                                             are included in
                                                                                the SIP for the
                                                                                limited purpose
                                                                                of satisfying
                                                                                the requirements
                                                                                of Clean Air Act
                                                                                sections
                                                                                110(a)(2)(E)(ii)
                                                                                and 128.
                                                                                September 22,
                                                                                2004 is the
                                                                                Commonwealth
                                                                                approval date.
----------------------------------------------------------------------------------------------------------------

0
4. Add Sec.  52.2730 to read as follows:

Sec.  52.2730   Section 110(a)(2) infrastructure requirements.

    (a) 1997 8-hour ozone and the 1997 PM2.5 NAAQS--(1)
Approval. Submittal from Puerto Rico dated November 29, 2006 and
supplemented February 1, 2016, to address the CAA infrastructure
requirements for the 1997 ozone and the 1997 PM2.5 NAAQS.
This submittal satisfies the 1997 ozone and the 1997 PM2.5
NAAQS requirements of the Clean Air Act (CAA) 110(a)(2)(A), (B), (C)
(with the exception of program requirements for PSD), (D)(i)(II) and
(ii) (with the exception of program requirements related to PSD), (E),
(F), (G), (H), (J) (with the exception of program requirements related
to PSD), (K), (L), and (M).
    (2) Disapproval. Submittal from Puerto Rico dated November 29, 2006
and supplemented February 1, 2016, to address the CAA infrastructure
requirements for the 1997 ozone and the 1997 PM2.5 NAAQS are
disapproved for the following sections: 110(a)(2)(C) (PSD program
only), (D)(i)(II), PSD program only), (D)(ii) (PSD program only) and
(J) (PSD program only). These requirements are being addressed by Sec.
52.2729 which has been delegated to Puerto Rico to implement.
    (b) 2008 ozone and the 2006 PM2.5 NAAQS--(1) Approval. Submittal
from Puerto Rico dated January 22, 2013, supplemented February 1, 2016
to address the CAA infrastructure requirements for the 2008 ozone NAAQS
and supplemented April 16, 2015 and February 1, 2016 to address the CAA
infrastructure requirements for the 2006 PM2.5 NAAQS. This
submittal satisfies the 2008 ozone and the 2006 PM2.5 NAAQS
requirements of the Clean Air Act (CAA) 110(a)(2)(A), (B), (C) (with
the exception of program requirements for PSD), (D)(i)(II) and (ii)
(with the exception of program requirements related to PSD), (E), (F),
(G), (H), (J) (with the exception of program requirements related to
PSD), (K), (L), and (M).
    (2) Disapproval. Submittal from Puerto Rico dated January 22, 2013
and supplemented April 16, 2015 and February 1, 2016, to address the
CAA infrastructure requirements for the 2008 ozone and the 2006
PM2.5 NAAQS are disapproved for the following sections:
110(a)(2)(C) (PSD program only), (D)(i)(II) (PSD program only), (D)(ii)
(PSD program only) and (J) (PSD program only). These requirements are
being addressed by Sec.  52.2729 which has been delegated to Puerto
Rico to implement.
    (c) 2008 lead NAAQS--(1) Approval. Submittal from Puerto Rico dated
January 31, 2013 and supplemented February 1, 2016, to address the CAA
infrastructure requirements for the 2008 lead NAAQS. This submittal
satisfies the 2008 lead NAAQS requirements of the Clean Air Act (CAA)
110(a)(2)(A), (B), (C) (with the exception of program requirements for
PSD), (D)(i)(II) and (ii) (with the exception of program requirements
related to PSD), (E), (F), (G), (H), (J) (with the exception of program
requirements related to PSD), (K), (L), and (M).
    (2) Disapproval. Submittal from Puerto Rico dated January 31, 2013
and supplemented February 1, 2016, to address the CAA infrastructure
requirements for the 2008 lead NAAQS are disapproved for the following
sections: 110(a)(2)(C) (PSD program only), (D)(i)(II) (PSD program
only), (D)(ii) (PSD program only) and (J) (PSD program only). These
requirements are being addressed by Sec.  52.2729 which has been
delegated to Puerto Rico to implement.

[FR Doc. 2016-21326 Filed 9-12-16; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 114 (Tuesday, June 14, 2011)]
[Notices]
[Pages 34783-34785]
[FR Doc No: 2011-14591]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64630; File No. SR-NASDAQ-2011-074]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend Rule 7034 Regarding Certain Co-Location Installation Fees

June 8, 2011.
    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 May 26, 2011, The NASDAQ Stock Market LLC (``NASDAQ'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to amend Rule 7034 regarding fees assessed
for the installation of certain co-location services. The Exchange will
implement the proposed change on June 1, 2011. The text of the proposed
rule change is available at http://nasdaq.cchwallstreet.com/, at the
Exchange's principal office, and at the Commission's Public Reference
Room.

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

    In its filing with the Commission, the 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 proposes to amend Rule 7034 regarding fees assessed
for the installation of certain co-location services to further
incentivize the use of the co-location services. The installation fees
for the following co-location services will be waived commencing June
1, 2011 and ending June 30, 2011(the ``designated period''). Beginning
July 1, 2011, the above-referenced waived fees will resume in full at
the amount prior to [sic] designated period. The Exchange proposes to
waive the following installation fees during the designated period:
    1. Rule 7034(a): Installation fees for new cabinets with power.
    2. Rule 7034(b): Installation fees for external telecommunication,
inter-cabinet connectivity, connectivity to NASDAQ and market data
connectivity related to an order for a new cabinet. However, the one-
time telecommunication connectivity expedite fee \3\ will not be waived
during the designated period.
---------------------------------------------------------------------------

    \3\ The one-time telecommunication connectivity expedite fee is
a fee for an optional request to complete the installation in a
shorter time period than the install timeframes.
---------------------------------------------------------------------------

    3. Rule 7034(c): Installation fees for cabinet power related to an
order for a new cabinet.
    4. Rule 7034(d): Installation fees for cooling fans, perforated
floor tiles and fiber downspouts, which are necessary items to support
a higher density cabinet and fiber cross connects, relating to an order
for a new cabinet placed during the designated period. Installation
fees for other items that are customized or options are not waived
during the time period.
    The following requirements must be met to receive the waiver of the
installation fee:
    1. the new cabinet order must be placed in the CoLo Console \4\
during the designated period; and
---------------------------------------------------------------------------

    \4\ The ``CoLo Console'' is Web-based ordering tool that is
utilized by NASDAQ to place co-location orders.
---------------------------------------------------------------------------

    2. the new cabinet must be live within 90 days of the date of the
order \5\.
---------------------------------------------------------------------------

    \5\ Exchange staff generally installs and makes operational a
new cabinet within 90 days of the date of the order (the ``live
date''). The estimated live date is communicated to the customer.
However, there may be instances where the customer desires the live
date to be later than the estimated live date provided by Exchange
staff. In such instances, the live date cannot extend beyond 90 days
of the date of the order.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Act,\6\ in general, and with
Section 6(b)(4) of the Act,\7\ in particular, in that it provides for
the equitable allocation of reasonable dues, fees and other charges
among members and issuers and other persons using any facility or
system which the Exchange operates or controls. The proposed
installation fees in [sic] which the Exchange seeks a temporary waiver
will be assessed equally to customers that place an order for a new
cabinet during the designated period. The proposed amendments will
provide an incentive for customers to avail themselves of the
designated co-location services. The proposal is similar to the waiver
of fees during an introductory period for a product, and is equitable
because all persons may avail themselves of the waiver during the
period of its availability.
---------------------------------------------------------------------------

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

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

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act, as amended. The
Exchange believes that the waiver of fees for certain co-location
services is equitable because all persons may avail themselves of the
waiver during the period of its availability.

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

    Written comments were neither solicited nor received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\8\ At any time within 60 days of the filing
of the proposed rule change, the Commission summarily may temporarily
suspend such rule change if it appears to the Commission that such
action is necessary or appropriate in the public interest, for the
protection of investors, or otherwise in furtherance of the purposes of
the Act. If the Commission takes such action, the Commission shall
institute proceedings to determine whether the proposed rule should be
approved or disapproved.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(a)(ii) [sic].
---------------------------------------------------------------------------

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-NASDAQ-2011-074 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2011-074. 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 Web site
viewing and printing in the Commission's Public Reference Room, 100 F
Street, NE., Washington, DC 20549, on official business days between
the hours of 10 a.m. and 3 p.m. Copies of such filing also will be
available for inspection and copying at the principal offices of the
Exchange. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly.
    All submissions should refer to File Number SR-NASDAQ-2011-074, and
should be submitted on or before July 5, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-14591 Filed 6-13-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 71 (Friday, April 12, 2013)]
[Notices]
[Page 22025]
[FR Doc No: 2013-08542]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Twenty First Meeting: RTCA Special Committee 224, Airport
Security Access Control Systems

AGENCY: Federal Aviation Administration (FAA), U.S. Department of
Transportation (DOT).

ACTION: Meeting Notice of RTCA Special Committee 224, Airport Security
Access Control Systems.

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

SUMMARY: The FAA is issuing this notice to advise the public of the
twenty first meeting of the RTCA Special Committee 224, Airport
Security Access Control Systems.

DATES: The meeting will be held April 9-10, 2013 from 9:00 a.m.-5:00
p.m.

ADDRESSES: The meeting will be held at RTCA, Inc., 1150 18th Street
NW., Suite 910, Washington, DC 20036.

FOR FURTHER INFORMATION CONTACT: The RTCA Secretariat, 1150 18th Street
NW., Suite 910, Washington, DC 20036, or by telephone at (202) 833-
9339, fax at<PHONE_NUMBER>, or Web site at http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for a meeting of Special Committee 224. The agenda will
include the following:

May 9-10, 2013

     Welcome, Introductions & Administrative Remarks
     Review and Approve Summary of Twentieth Meeting
     Updates from TSA (as required)
     Document Detailed Review
     Document Finalization Process
     Time and Place of Next Meeting
     Any Other Business
     Adjourn
    Attendance is open to the interested public but limited to space
availability. With the approval of the chairman, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on April 5, 2013.
Paige Williams,
Management Analyst, NextGen, Business Operations Group, Federal
Aviation Administration.
[FR Doc. 2013-08542 Filed 4-11-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 20 (Thursday, January 30, 2014)]
[Notices]
[Pages 4900-4901]
[FR Doc No: 2014-01869]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP14-45-000]

Dominion Transmission, Inc.; Notice of Request Under Blanket
Authorization

    Take notice that January 9, 2014, Dominion Transmission, Inc.
(Dominion), 701 East Cary Street, Richmond, Virginia 23219, filed a
prior notice application pursuant to sections 157.205 and 157.208 of
the Federal Energy Regulatory Commission's (Commission) regulations
under the Natural Gas Act (NGA), and Dominion's blanket certificate
issued in Docket No. CP82-537-000, for authorization to replace certain
pipeline facilities (Project) located in Westmoreland County,
Pennsylvania. Specifically, the Project consists of replacing 9.7 miles
of various diameter pipelines, all as more fully set forth in the
application, which is open to the public for inspection. The filing may
also be viewed on the web at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket

number excluding the last three digits in the docket number field to
access the document. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TTY,
(202) 502-8659.
    Any questions regarding this application should be directed to
Tiffany Werts, Regulatory and Certificates Analyst, Dominion
Transmission, Inc., 701 East Cary Street, Richmond, VA 23219, or
telephone<PHONE_NUMBER> or fax<PHONE_NUMBER> or by email
<EMAIL_ADDRESS>    Any person or the Commission's staff may, within 60 days after
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention and pursuant to Section 157.205 of
the regulations under the NGA (18 CFR 157.205), a protest to the
request. If no protest is filed within the time allowed therefor, the
proposed activity shall be deemed to be authorized effective the day
after the time allowed for filing a protest. If a protest is filed and
not withdrawn within 30 days after the allowed time for filing a
protest, the instant request shall be treated as an application for
authorization pursuant to section 7 of the NGA.
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding, or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenter's will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenter's will not be required to serve copies of filed
documents on all other parties. However, the non-party commentary, will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 5 copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426.

    Dated: January 23, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-01869 Filed 1-29-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 41 (Thursday, March 1, 2012)]
[Proposed Rules]
[Pages 12506-12508]
[FR Doc No: 2012-4931]

========================================================================
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. 77, No. 41 / Thursday, March 1, 2012 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0187; Directorate Identifier 2011-NM-094-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain The Boeing Company Model 757 airplanes. This proposed AD was
prompted by fuel system reviews conducted by the manufacturer. This
proposed AD would require modifying the fuel quantity indication system
(FQIS) wiring or fuel tank systems to prevent development of an
ignition source inside the center fuel tank. We are proposing this AD
to prevent ignition sources inside the center fuel tank, which, in
combination with flammable fuel vapors, could result in fuel tank
explosions and consequent loss of the airplane.

DATES: We must receive comments on this proposed AD by April 30, 2012.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (phone:<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

FOR FURTHER INFORMATION CONTACT: Tak Kobayashi, Aerospace Engineer,
Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification Office
(ACO), 1601 Lind Avenue SW., Renton, Washington 98057-3356; phone: 425-
917-6499; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2012-0187;
Directorate Identifier 2011-NM-094-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The FAA has examined the underlying safety issues involved in fuel
tank explosions on several large transport airplanes, including the
adequacy of existing regulations, the service history of airplanes
subject to those regulations, and existing maintenance practices for
fuel tank systems. As a result of those findings, we issued a
regulation titled ``Transport Airplane Fuel Tank System Design Review,
Flammability Reduction and Maintenance and Inspection Requirements''
(66 FR 23086, May 7, 2001). In addition to new airworthiness standards
for transport airplanes and new maintenance requirements, this rule
included Special Federal Aviation Regulation No. 88 (``SFAR 88,''
Amendment 21-78, and subsequent Amendments 21-82 and 21-83).
    Among other actions, SFAR 88 requires certain type design (i.e.,
type certificate (TC) and supplemental type certificate (STC)) holders
to substantiate that their fuel tank systems can prevent ignition
sources in the fuel tanks. This requirement applies to type design
holders for large turbine-powered transport airplanes and for
subsequent modifications to those airplanes. It requires them to
perform design reviews and to develop design changes and maintenance
procedures if their designs do not meet the new fuel tank safety
standards. As explained in the preamble to the rule, we intended to
adopt airworthiness directives to mandate any changes found necessary
to address unsafe conditions identified as a result of these reviews.
    In evaluating these design reviews, we have established four
criteria intended to define the unsafe conditions associated with fuel
tank systems that require corrective actions. The percentage of
operating time during which fuel tanks are exposed to flammable
conditions is one of these criteria. The other three criteria address
the failure types under evaluation: single failures, a combination of
failures, and unacceptable service (failure) experience. For all four
criteria, the evaluations included consideration of previous actions
taken that may mitigate the need for further action.
    We have determined that the actions identified in this proposed AD
are necessary to reduce the potential of ignition sources inside the
center fuel tank, which has been identified to have a high flammability
exposure. Ignition sources inside the center fuel tank, in combination
with flammable fuel vapors, could result in fuel tank explosions and
consequent loss of the airplane.
    The combination of a latent failure within the center fuel tank and
a subsequent single failure of the fuel quantity indicating system
(FQIS) wiring or components outside the fuel tank can cause development
of an

ignition source inside the center fuel tank. Latent in-tank failures,
including corrosion/deposits at wire terminals, conductive debris on
fuel system probes, wires or probes contacting the tank structure, and
wire faults, could create a conductive path inside the center fuel
tank. Out-tank single failures including hot shorts in airplane wiring
and/or the FQIS processor could result in electrical energy being
transmitted into the center fuel tank via the FQIS wiring. The
electrical energy, if combined with a latent in-tank failure, could be
sufficient to create an ignition source inside the center fuel tank,
which, combined with flammable fuel vapors could result in a
catastrophic fuel tank explosion.

SFAR 88 and Fuel Tank Flammability Reduction Rule

    The National Transportation Safety Board (NTSB) determined that the
combination of a latent failure inside the center fuel tank and a
subsequent single failure of the FQIS wiring or components outside the
fuel tank was the most likely ignition source inside the center fuel
tank that resulted in the TWA Flight 800 explosion. After the TWA 800
accident, we issued AD 99-03-04, Amendment 39-11018 (64 FR 4959,
February 2, 1999), and AD 98-20-40, Amendment 39-10808 (63 FR 52147,
September 30, 1998), mandating separation of the FQIS wiring that
penetrates the fuel tank from high power wires and circuits on the
classic Boeing 737 and 747 airplanes. Those ADs resulted in
installation of Transient Suppression Units (TSUs), Transient
Suppression Devices (TSDs), or Isolated Fuel Quantity Transmitter
(IFQT) as a method of compliance with the AD requirements.
    After we issued those ADs, the findings from the SFAR 88 review
showed that most transport category airplanes with high flammability
fuel tanks needed TSUs, TSDs, or IFQTs to prevent electrical energy
from entering the fuel tanks via the FQIS wiring in the event of a
latent failure in combination with a single failure.
    Installation of those FQIS protection devices, however, was
determined unnecessary on those airplanes that are required to comply
with the ``Reduction of Fuel Tank Flammability in Transport Category
Airplanes'' rule (73 FR 42444, July 21, 2008), referred to as the Fuel
Tank Flammability Reduction (FTFR) rule. The FTFR rule requires
incorporation of a flammability reduction means (FRM) that converts
high flammability fuel tanks into low flammability fuel tanks for
certain airplane models. Therefore, the unsafe condition identified by
SFAR 88 is mitigated by incorporation of an FRM, as discussed in the
FTFR rule.
    This proposed AD is intended to address the unsafe condition
associated with the FQIS wiring that penetrates the center fuel tank
for all Boeing Model 757 airplanes that are not subject to the
requirements of the FTFR rule. This proposed AD would apply to
airplanes operated in all-cargo service and airplanes operated under
Title 14 Code of Federal Regulations (CFR) part 91, since those
airplanes are not subject to the requirements of the FTFR rule. Also,
this proposed AD would apply to airplanes for which the State of
Manufacture issued the original certificate of airworthiness or export
airworthiness approval prior to January 1, 1992, since those airplanes
are also not subject to the requirements of the FTFR rule. However, as
explained in paragraph 2-5.a. of Advisory Circular 120-98, ``Operator
Requirements for Incorporation of Fuel Tank Flammability Reduction
Requirements,'' dated May 7, 2009, to operate a pre-1992 airplane in
passenger service after December 26, 2017, operators must incorporate
an FRM that meets the requirements of Sec.  26.33(c) before that date.
For such airplanes on which an FRM is incorporated, further compliance
with this proposed AD is not required.
    The nitrogen generating system (NGS) being developed by Boeing to
meet the FTFR rule addresses the unsafe condition of this AD, as well
as providing other safety improvements. Paragraph (h) of this proposed
AD provides that, for operators not required to comply with the FTFR
rule, electing to comply with the FTFR rule would be an acceptable
method of addressing the unsafe condition.
    As discussed in the FTFR rule, the FAA recognized that separate
airworthiness actions would be initiated to address the remaining fuel
system safety issues for airplanes for which an FRM is not required. We
have notified design approval holders that service instructions to
support introduction of FQIS protection are now necessary for fuel
tanks that are not required to be modified with an FRM by the FTFR
rule. To date we have not received any service information from Boeing
addressing this specific threat; therefore, we are proceeding with this
proposal, which would require modifications using methods approved by
the Manager of the Seattle Aircraft Certification Office.
    We plan similar actions for those Boeing and Airbus airplanes with
similar FQIS vulnerabilities that are not affected by the FTFR rule.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would require modifying the FQIS wiring or fuel
tank systems to prevent development of an ignition source inside the
center fuel tank.

Costs of Compliance

    We estimate that this proposed AD affects 352 airplanes of U.S.
registry. We have been advised that some of those airplanes are subject
to the requirements of the FTFR rule and therefore are excluded from
the requirements of this AD.
    Because the manufacturer has not yet developed a modification
commensurate with the actions specified by this proposed AD, we cannot
provide specific information regarding the required number of work
hours or the cost of parts to do the proposed modification. In
addition, modification costs will likely vary depending on the operator
and the airplane configuration. The proposed compliance time of 60
months should provide ample time for the development, approval, and
installation of an appropriate modification.
    Based on similar modifications, however, we can provide some
estimated costs for the proposed modification in this NPRM. The
modifications mandated by AD 99-03-04, Amendment 39-11018 (64 FR 4959,
February 2, 1999), and AD 98-20-40, Amendment 39-10808 (63 FR 52147,
September 30, 1998), for the classic Boeing Model 737 and 747 airplanes
(i.e., TSD, TSU, IFQT) are not available for Boeing Model 757
airplanes. But, based on the costs associated with those modifications,
we estimate the cost of this new proposed modification to be no more
than $100,000 per airplane. The Honeywell FQIS may need additional
modifications, which may cost as much as $100,000 per airplane. The
cost impact of the proposed AD therefore is estimated to be between
$100,000 and $200,000 per airplane.
    As indicated earlier in this preamble, we specifically invite the
submission of comments and other data regarding the costs of this
proposed AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
subtitle VII, part A, subpart III, section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

    1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new
airworthiness directive (AD):

The Boeing Company: Docket No. FAA-2012-0187; Directorate Identifier
2011-NM-094-AD.

(a) Comments Due Date

    We must receive comments by April 30, 2012.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 757-200, -200PF, -
200CB, and -300 series airplanes; certificated in any category; for
which compliance with 14 CFR 121.1117(d), 125.509(d), or 129.117(d)
is not required; regardless of the date of issuance of the original
certificate of airworthiness or export airworthiness approval.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 7397: Engine fuel system wiring.

(e) Unsafe Condition

    This AD was prompted by fuel system reviews conducted by the
manufacturer. We are issuing this AD to prevent development of an
ignition source inside the center fuel tank caused by a latent in-
tank failure combined with electrical energy transmitted into the
center fuel tank via the fuel quantity indicating system (FQIS)
wiring due to a single out-tank failure.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Modification

    Within 60 months after the effective date of this AD, modify the
FQIS wiring or fuel tank systems to prevent development of an
ignition source inside the center fuel tank, in accordance with a
method approved by the Manager, Seattle Aircraft Certification
Office (ACO), FAA.

    Note 1 to paragraph (g) of this AD: After accomplishment of the
actions required by paragraph (g) of this AD, maintenance and/or
preventive maintenance under 14 CFR part 43 is permitted provided
the maintenance does not result in changing the AD-mandated
configuration (reference 14 CFR 39.7).

(h) Optional Installation of Flammability Reduction Means

    As an alternative to the requirements of paragraph (g) of this
AD, operators may elect to comply with the requirements of 14 CFR
121.1117 or 14 CFR 125.509 or 14 CFR 129.117 (not including the
exclusion of cargo airplanes in Sections 121.1117(j), 129.117(j),
and 125.509(j)). Following this election, failure to comply with
Sections 121.1117, 129.117, and 125.509 is a violation of this AD.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle ACO, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the manager of the
ACO, send it to the attention of the person identified in the
Related Information section of this AD. Information may be emailed
to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(j) Related Information

    For more information about this AD, contact Tak Kobayashi,
Aerospace Engineer, Propulsion Branch, ANM-140S, FAA, Seattle
Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton,
Washington 98057-3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
    Issued in Renton, Washington, on February 21, 2012.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-4931 Filed 2-29-12; 8:45 am]
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[Federal Register Volume 80, Number 126 (Wednesday, July 1, 2015)]
[Notices]
[Page 37712]
[FR Doc No: 2015-16207]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Release From Federal Grant Assurance Obligations for
Elko Regional Airport (EKO), Elko, Nevada

AGENCY: Federal Aviation Administration, DOT.

ACTION: Notice of request to release airport land.

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

SUMMARY: The Federal Aviation Administration (FAA) proposes to rule and
invites public comment on the application for a release of
approximately 5,037 square feet of airport property at the Elko
Municipal Airport (Airport), City of Elko, Nevada. The City of Elko
proposes to release the airport land in order to acquire an equal 5,037
square feet parcel of privately-owned land. The land exchange was
proposed after a 2011 deed survey disclosed that the airport perimeter
fence encroached into private property abutting the airport. Relocation
of the fence is not practical due to the cost associated with moving
the fence and underground utilities. The parties concluded that the
encroachment problem could be resolved with an equitable land exchange.
Since the release land is not needed for airport purposes, the exchange
will not negatively impact the airport or civil aviation.

DATES: Comments must be received on or before July 31, 2015.

FOR FURTHER INFORMATION CONTACT: Comments on the request may be mailed
or delivered to the FAA at the following address Mike N. Williams,
Manager, Federal Aviation Administration, Phoenix Airports District
Office, Federal Register Comment, 3800 N. Central Avenue, Suite 1025,
10th Floor, Phoenix, Arizona 85012. In addition, one copy of the
comment submitted to the FAA must be mailed or delivered to Mr. Mark
Gibbs, Airport Director, Elko Regional Airport, 975 Terminal Way, Elko,
Nevada 89801.

SUPPLEMENTARY INFORMATION: In accordance with the Wendell H. Ford
Aviation Investment and Reform Act for the 21st Century (AIR 21),
Public Law 106-181 (Apr. 5, 2000; 114 Stat. 61), this notice must be
published in the Federal Register 30 days before the Secretary may
waive any condition imposed on a federally obligated airport by surplus
property conveyance deeds or grant agreements.
    The following is a brief overview of the request:
    The City of Elko, Nevada requested a release from sponsor grant
assurance obligations for approximately 5,037 square feet of airport
land to facilitate a land exchange so the airport can acquire an equal
5,037 square feet of privately-owned land. A land survey conducted in
2011 disclosed that the airport perimeter fence encroached into private
property abutting the airport. Relocating the fence line and
underground utilities would be costly for the Airport. The City offered
to trade a parcel of unused airport land that is not needed for airport
purposes for the portion of land into which the airport fence
encroaches. The land exchange would conform to Nevada Revised Statutes
for Boundary Line Adjustments. Appraisals concluded the two parcels
have equal values. As a result, the City and land owner concluded that
a land swap would represent an equitable and less expensive way to
resolve the encroachment problem. The release land is not needed for
airport purposes and land exchange will result in no net loss in value
or negative impact for the airport. The reuse of the released parcel
for commercial purposes represents a compatible land use that will not
interfere with the airport or its operation. The acquisition of the
privately owned parcel will obviate the need to relocate the perimeter
fence. Therefore, the exchange provides a benefit to the airport and
civil aviation.

    Issued in Phoenix, Arizona: June 26, 2015.
Mike N. Williams,
Manager, Phoenix Airports District Office, Western-Pacific Region.
[FR Doc. 2015-16207 Filed 6-30-15; 8:45 am]
BILLING CODE 4910-13-P


"King, Heidi R."<EMAIL_ADDRESS> 01/16/2008 03:23 PM

To

Lydia Wegman/RTP/USEPA/US@EPA

cc

Erika Sasser/RTP/USEPA/US@EPA, Tricia Crabtree/RTP/USEPA/US@EPA, Kathy Kaufman/RTP/USEPA/US@EPA

Subject

RE: Near Roadway information for Tom Grahame

Thank you; I'll share with the broader group, as I believe this is also

of interest to Dept of Transportation.

Thanks Lydia,

heidi

-----Original Message-----

From<EMAIL_ADDRESS><EMAIL_ADDRESS> Sent: Wednesday, January 16, 2008 3:22 PM

To: King, Heidi R.

Cc<EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS> Subject: Fw: Near Roadway information for Tom Grahame

Below is a note that provides a guide for Tom Grahame to information

that answers one of the questions he asked during our meeting today.

----- Forwarded by Lydia Wegman/RTP/USEPA/US on 01/16/2008 03:20 PM

-----

             Erika

             Sasser/RTP/USEPA

             /US                                                     To

                                      Lydia Wegman/RTP/USEPA/US@EPA

             01/16/2008 12:57                                        cc

             PM                       Kathy Kaufman/RTP/USEPA/US@EPA,

                                      Deirdre Murphy/RTP/USEPA/US@EPA

                                                                Subject

                                      Near Roadway information for Tom

                                      Grahame

Tom Grahame asked whether we had information regarding lead

concentrations near roadways (such as gradient studies).  Deirdre

identified 2 sections of the Criteria document and 1 appendix to the

Lead Risk Assessment that deal with lead in outdoor soil and dust near

roadways.  These are:

Criteria Document

   Chapter 2, section 2.3.3 "Resuspension of Lead Containing Dust and

   Soil"

   Chapter 3, section 3.2  "Exposure:  Soil and Dust"

Risk Assessment

   Appendix F:  "Lead in Outdoor Soil and Dust near Roadways"-- this

   appendix includes a table listing key studies and summarizing their

   design/findings in terms of lead concentrations

Perhaps we could send this to Heidi to forward on to Tom, along with the

links to CD, Staff Paper, and Risk Assessment?


[Federal Register Volume 83, Number 139 (Thursday, July 19, 2018)]
[Notices]
[Pages 34141-34142]
[FR Doc No: 2018-15391]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-0643]

Labeling for Biosimilar Products; Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Labeling
for Biosimilar Products.'' This guidance is intended to help applicants
develop draft labeling for proposed biosimilar products. The
recommendations for prescription drug labeling in this guidance pertain
only to the prescribing information (commonly referred to as the
package insert), except for certain recommendations pertaining to FDA-
approved patient labeling (e.g., Patient Information, Medication Guide,
and Instructions for Use). This guidance provides an overview of FDA's
recommendations for labeling for biosimilar products. This guidance
finalizes the draft guidance issued on April 4, 2016.

DATES: The announcement of the guidance is published in the Federal
Register on July 19, 2018.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-0643 for ``Labeling for Biosimilar Products; Guidance for
Industry; Availability.'' 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.
     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.gpo.gov/fdsys/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.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Sandra Benton, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 6522, Silver Spring, MD 20993, 301-796-
1042; or Stephen Ripley, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7268, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Labeling for Biosimilar Products.'' The Biologics Price
Competition and Innovation Act of 2009 (BPCI Act), enacted as part of
the Patient Protection and Affordable Care Act (Affordable Care Act)
(Pub. L. 111-148) on March 23, 2010, created an abbreviated licensure
pathway for biological products demonstrated to be biosimilar to or
interchangeable with an FDA-licensed reference product. Section 351(k)
of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)), added by
the BPCI Act, sets forth the requirements for an application for a
proposed biosimilar product and an application or supplement for a
proposed interchangeable product. Under section 351(k) of the PHS Act,
a

proposed biological product that is demonstrated to be biosimilar to a
reference product can rely on certain existing scientific knowledge
about the safety, purity, and potency of the reference product to
support licensure, and this is reflected in the approach to biosimilar
product labeling.
    In this guidance, FDA outlines its recommendations for biosimilar
product labeling. A demonstration of biosimilarity means, among other
things, that FDA has determined that there are no clinically meaningful
differences between the proposed product and the reference product in
terms of safety, purity, and potency. Accordingly, biosimilar
applicants should incorporate relevant data and information from the
reference product labeling, with appropriate modifications as
recommended in the guidance.
    This guidance finalizes the draft guidance issued on April 4, 2016.
Changes made to the guidance took into consideration the comments
received, as well as requests regarding the requirements for and/or
contents of biosimilar labeling made in the following citizen
petitions: FDA-2015-P-2000 (submitted by AbbVie, Inc.), FDA-2015-P-4529
(submitted by a group of institutional investors including the United
Auto Workers (UAW) Retiree Medical Benefits Trust), and FDA-2015-P-0776
(submitted by the Pharmaceutical Research and Manufacturers of America
and the Biotechnology Industry Organization) (these citizen petitions
are available at https://www.regulations.gov). Editorial changes were
made primarily for clarification.
    In the Federal Register of April 4, 2016 (81 FR 19194), FDA
announced the availability of the draft guidance for industry
``Labeling for Biosimilar Products.'' FDA requested comment on whether
FDA-approved patient labeling (e.g., Patient Information, Medication
Guide, and Instructions for Use) should include a biosimilarity
statement similar to the statement described in section IV.C.1 of the
draft guidance. Several comments agreed with inclusion of the
biosimilarity statement; one comment disagreed. FDA considered the
comments received, but decided not to recommend inclusion of a
biosimilarity statement in FDA-approved patient labeling at this time.
    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 ``Labeling for Biosimilar Products.'' 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. This guidance
is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. 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 for the submission of a biologics license
application under section 351(k) of the PHS Act have been approved
under OMB control number 0910-0719; the collections of information in
21 CFR 201.56 and 201.57 for the submission of labeling have been
approved under OMB control number 0910-0572; the collections of
information in 21 CFR part 208 for Medication Guides have been approved
under OMB control number 0910-0393; the collections of information in
21 CFR 312.47 for meetings with FDA have been approved under OMB
control number 0910-0014; the collections of information in 21 CFR part
600 for the submission of adverse experience reporting for licensed
biological products and general records have been approved under OMB
control number 0910-0308; and the collections of information in 21 CFR
part 601 for the submission of labeling in a biologics license
application or supplement to a biologics license application have been
approved under OMB control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.

    Dated: July 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-15391 Filed 7-18-18; 8:45 am]
BILLING CODE 4164-01-P