\115\ As shown, the tariff language to be used should reference
Version 001 of WEQ-006, as we are not incorporating by reference
Version 002.1 of WEQ-006 at this time.
---------------------------------------------------------------------------

     Open Access Same-Time Information Systems (OASIS), Version
1.5 (WEQ-001, Version 002.1, March 11, 2009, with minor corrections
applied May 29, 2009 and September 8, 2009), with the exception of
Standards 001-0.1, 001-0.9 through 001-0.13, 001-1.0, 001-9.7, 001-
14.1.3, and 001-15.1.2;
     Open Access Same-Time Information Systems (OASIS)
Standards & Communications Protocols, Version 1.5 (WEQ-002, Version
002.1, March 11, 2009, with minor corrections applied May 29, 2009 and
September 8, 2009);
     Open Access Same-Time Information Systems (OASIS) Data
Dictionary, Version 1.5 (WEQ-003, Version 002.1, March 11, 2009, with
minor corrections applied May 29, 2009 and September 8, 2009);
     Coordinate Interchange (WEQ-004, Version 002.1, March 11,
2009, with minor corrections applied May 29, 2009 and September 8,
2009);
     Area Control Error (ACE) Equation Special Cases (WEQ-005,
Version 002.1, March 11, 2009, with minor corrections applied May 29,
2009 and September 8, 2009);
     Manual Time Error Correction (WEQ-006, Version 001,
October 31, 2007, with minor corrections applied on Nov. 16, 2007);
     Inadvertent Interchange Payback (WEQ-007, Version 002.1,
March 11, 2009, with minor corrections applied May 29, 2009 and
September 8, 2009);
     Transmission Loading Relief--Eastern Interconnection (WEQ-
008, Version 002.1, March 11, 2009, with minor corrections applied May
29, 2009 and September 8, 2009);
     Gas/Electric Coordination (WEQ-011, Version 002.1, March
11, 2009, with minor corrections applied May 29, 2009 and September 8,
2009);
     Public Key Infrastructure (PKI) (WEQ-012, Version 002.1,
March 11, 2009, with minor corrections applied May 29, 2009 and
September 8, 2009); and
     Open Access Same-Time Information Systems (OASIS)
Implementation Guide, Version 1.5 (WEQ-013, Version 002.1, March 11,
2009, with minor corrections applied May 29, 2009 and September 8,
2009).
    130. If a public utility requests waiver of a standard, it will not
be required to comply with the standard until the Commission acts on
its waiver request. Therefore, if a public utility has obtained a
waiver or has a pending request for a waiver, its proposed revision to
its OATT should not include the standard number associated with the
standard for which it has obtained or seeks a waiver. Instead, the
public utility's OATT should specify those standards for which the
public utility has obtained a waiver or has pending a request for
waiver. Once a waiver request is denied, the public utility will be
required to include in its OATT the standard(s) for which waiver was
denied.

IV. Notice of Use of Voluntary Consensus Standards

    131. Office of Management and Budget Circular A-119 (section 11)
(February 10, 1998) provides that when a federal agency issues or
revises a regulation containing a standard, the agency should publish a
statement in the Final Rule stating whether the adopted standard is a
voluntary consensus standard or a government-unique standard. In this
rulemaking, the Commission is incorporating by reference voluntary
consensus standards developed by the WEQ.

V. Information Collection Statement

    132. OMB's regulations in 5 CFR 1320.11 (2005) require that it
approve certain reporting and recordkeeping requirements (collections
of information) imposed by an agency. Upon approval of a collection of
information, OMB assigns an OMB control number and an expiration date.
Respondents subject to the filing requirements of this Final Rule will
not be penalized for failing to respond to this collection of
information unless the collection of information displays a valid OMB
control number.
    133. This Final Rule will affect the following existing data
collections: Standards for Business Practices and Communication
Protocols for Public Utilities (FERC-717) and Electric Rate Schedule
Filings (FERC-516).
    134. The following burden estimate is based on the projected costs
for the industry to implement revisions to the WEQ Standards currently
incorporated by reference into the Commission's regulations at 18 CFR
38.2 and to implement the new standards adopted by NAESB that we are
incorporating by reference in this Final Rule.

----------------------------------------------------------------------------------------------------------------
                                                                Number of
             Data collection                  Number of       responses per       Hours per     Total number  of
                                             respondents       respondent         response            hours
----------------------------------------------------------------------------------------------------------------
FERC-516................................               176                 1                 6             1,056
FERC-717................................               176                 1                30             5,280
                                         -----------------------------------------------------------------------
    Totals..............................  ................  ................  ................             6,336
----------------------------------------------------------------------------------------------------------------

    Total Annual Hours for Collection:
    (Reporting and Recordkeeping, (if appropriate)) = 6336 hours.
    Information Collection Costs: The Commission projects the average
annualized cost for all respondents to be the following: \116\
---------------------------------------------------------------------------

    \116\ The total annualized cost for the information collections
is $2,344,320. This number is reached by multiplying the total hours
to prepare responses (6,336) by an hourly wage estimate of $370 (a
composite estimate that includes legal, technical and support staff
rates, $250 + $95 + $25 = $370), 6,336 hours x $370/hour =
$2,344,320.

------------------------------------------------------------------------
                                          FERC-516          FERC-717
------------------------------------------------------------------------
Annualized Capital/Startup Costs....          $390,720        $2,344,320
Annualized Costs (Operations &                     N/A  ................
 Maintenance).......................
                                     -----------------------------------
    Total Annualized Costs..........           390,720         2,344,320
------------------------------------------------------------------------

    135. The Commission sought comments on the burden of complying with
the requirements imposed by these requirements. No comments were filed
addressing the reporting burden.\117\
---------------------------------------------------------------------------

    \117\ We note, however, that two comments argued that it would
be too costly for small entities to obtain copies of the NAESB
Standards from NAESB. We addressed these comments in the preamble of
this Final Rule.
---------------------------------------------------------------------------

    136. The Commission's regulations adopted in this rule are
necessary to establish a more efficient and integrated wholesale
electric power grid. Requiring such information ensures both a common
means of communication and common business practices that provide
entities engaged in the wholesale transmission of electric power with
timely information and uniform business procedures across multiple
transmission providers. These requirements conform to the Commission's
goal for efficient information collection, communication, and
management within the electric power industry. The Commission has
assured itself, by means of its internal review, that there is
specific, objective support for the burden estimates associated with
the information requirements.
    137. OMB regulations \118\ require OMB to approve certain
information collection requirements imposed by agency rule. The
Commission is submitting notification of this proposed rule to OMB.
These information collections are mandatory requirements.
---------------------------------------------------------------------------

    \118\ 5 CFR 1320.11.
---------------------------------------------------------------------------

    Title: Standards for Business Practices and Communication Protocols
for Public Utilities (formerly Open Access Same Time Information
System) (FERC-717); Electric Rate Schedule Filings (FERC-516).
    Action: Final Rule.
    OMB Control No.: 1902-0096 (FERC-516); 1902-0173 (FERC-717).
    Respondents: Business or other for profit (Public Utilities--Not
applicable to small businesses).
    Frequency of Responses: One-time implementation (business
procedures, capital/start-up).
    Necessity of the Information: This rule will upgrade the
Commission's current business practice and communication standards to
comply with the Commission's determinations in Order Nos. 676-C, 890,
890-A, and 890-B, to explicitly include demand resources in the
definitions of certain ancillary services, to clarify parties' rollover
rights, to clarify the differences in timing requirements for the
Western Electricity Coordinating Council and all other interconnections
by modifying the Coordinate Interchange Timing Tables contained in
Appendix D of the Coordinate Interchange Standards (WEQ-004), and to
modify the Transmission Loading Relief--Eastern Interconnection
Standards (WEQ-008) to add clarity and ensure that the business
practice standards are consistent with NERC reliability standard IRO-
006.
    138. These changes will ensure that potential customers of open
access transmission service receive access to information that will
enable them to obtain transmission service on a non-discriminatory
basis, will assist the Commission in maintaining a safe and reliable
infrastructure and also will assure the reliability of the interstate
transmission grid. The implementation of these standards and
regulations is necessary to increase the efficiency of the wholesale
electric power grid.
    139. The information collection requirements of this Final Rule are
based on the transition from transactions being made under the
Commission's existing business practice standards to conducting such
transactions under the proposed revisions to these standards and to
account for the burden associated with the new standard(s) being
proposed here.
    140. Internal Review: The Commission has reviewed the revised
business practice standards and has made a determination that the
revisions adopted in this Final Rule are necessary to maintain
consistency between the business practice standards and reliability
standards on this subject. The Commission has assured itself, by means
of its internal review, that there is specific, objective support for
the burden estimate associated with the information requirements.
    141. Interested persons may obtain information on the reporting
requirements by contacting the following: Federal Energy Regulatory
Commission, Attn: Michael Miller, Office of the Executive Director, 888
First Street, NE., Washington, DC 20426, Tel:<PHONE_NUMBER>/Fax: (202)
273-0873, E-mail<EMAIL_ADDRESS>
VI. Environmental Analysis

    142. The Commission is required to prepare an Environmental
Assessment or an Environmental Impact Statement for any action that may
have a significant adverse effect on the human

environment.\119\ The Commission has categorically excluded certain
actions from these requirements as not having a significant effect on
the human environment.\120\
---------------------------------------------------------------------------

    \119\ Order No. 486, Regulations Implementing the National
Environmental Policy Act of 1969, 52 FR 47897 (Dec. 17, 1987), FERC
Stats. & Regs., Regs. Preambles ] 30,783 (1987).
    \120\ 18 CFR 380.4.
---------------------------------------------------------------------------

    143. The actions required by this Final Rule fall within
categorical exclusions in the Commission's regulations for rules that
are clarifying, corrective, or procedural, for information gathering,
analysis, and dissemination, and for sales, exchange, and
transportation of electric power that requires no construction of
facilities.\121\ Therefore, an environmental assessment is unnecessary
and has not been prepared in this Final Rule.
---------------------------------------------------------------------------

    \121\ See 18 CFR 380.4(a)(2)(ii), 380.4(a)(5), 380.4(a)(27).
---------------------------------------------------------------------------

VII. Regulatory Flexibility Act Certification

    144. The Regulatory Flexibility Act of 1980 (RFA)\122\ generally
requires a description and analysis of final rules that will have
significant economic impact on a substantial number of small entities.
The regulations adopted here impose requirements only on public
utilities, which are not small businesses, and, these requirements are,
in fact, designed to benefit all customers, including small businesses.
---------------------------------------------------------------------------

    \122\ 5 U.S.C. 601-612.
---------------------------------------------------------------------------

    145. The Commission has followed the provisions of both the RFA and
the Paperwork Reduction Act on potential impact on small business and
other small entities. Specifically, the RFA directs agencies to
consider four regulatory alternatives to be considered in a rulemaking
to lessen the impact on small entities: tiering or establishment of
different compliance or reporting requirements for small entities,
classification, consolidation, clarification or simplification of
compliance and reporting requirements, performance rather than design
standards, and exemptions. As the Commission originally stated in Order
No. 889, the OASIS regulations now known as Standards for Business
Practices and Communication Protocols for Public Utilities, apply only
to public utilities that own, operate, or control transmission
facilities subject to the Commission's jurisdiction and should a small
entity be subject to the Commission's jurisdiction, it may file for
waiver of the requirements.\123\ This is consistent with the exemption
provisions of the RFA. Accordingly, pursuant to section 605(b) of the
RFA,\124\ the Commission hereby certifies that the regulations proposed
herein will not have a significant adverse impact on a substantial
number of small entities.
---------------------------------------------------------------------------

    \123\ We also have provided for requests of waiver in instances
where compliance would be very burdensome and a waiver would not
diminish the overall benefits of the standards. See supra P 107,
130.
    \124\ 5 U.S.C. 605(b).
---------------------------------------------------------------------------

VIII. Document Availability

    146. 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 FERC's Home Page (http://www.ferc.gov) and in FERC's
Public Reference Room during normal business hours (8:30 a.m. to 5 p.m.
Eastern time) at 888 First Street, NE., Room 2A, Washington, DC 20426.
    147. From FERC's Home Page on the Internet, this information is
available in the eLibrary. The full text of this document is available
in the eLibrary both in PDF and Microsoft Word format for viewing,
printing, and/or downloading. To access this document in eLibrary, type
the docket number excluding the last three digits of this document in
the docket number field.\125\
---------------------------------------------------------------------------

    \125\ NAESB's Dec. 26, 2007 submittal is also available for
viewing in eLibrary. The link to this file is as follows: http://
elibrary.ferc.gov:0/idmws/doc_info.asp?document_id=13566661.
---------------------------------------------------------------------------

    148. User assistance is available for eLibrary and the FERC's
website during our normal business hours. For assistance contact FERC
Online Support at<EMAIL_ADDRESS>or toll-free at (866) 208-
3676, or for TTY, contact<PHONE_NUMBER>.

IX. Effective Date and Congressional Notification

    149. This Final Rule will become effective January 4, 2010. The
Commission has determined with the concurrence of the Administrator of
the Office of Information and Regulatory Affairs, Office of Management
and Budget, that this rule is not a major rule within the meaning of
section 251 of the Small Business Regulatory Enforcement Fairness Act
of 1996.\126\
---------------------------------------------------------------------------

    \126\ See 5 U.S.C. 804(2).
---------------------------------------------------------------------------

List of Subjects in 18 CFR Part 38

    Conflict of interests, Electric power plants, Electric utilities,
Incorporation by reference, Reporting and recordkeeping requirements.

    By the Commission.
Nathaniel J. Davis, Sr.,
Deputy Secretary.

0
In consideration of the foregoing, the Commission amends Chapter I,
Title 18, part 38 of the Code of Federal Regulations, as follows:

PART 38--BUSINESS PRACTICE STANDARDS AND COMMUNICATION PROTOCOLS
FOR PUBLIC UTILITIES

0
1. The authority citation for part 38 continues to read as follows:

    Authority: 16 U.S.C. 791-825r, 2601-2645; 31 U.S.C. 9701; 42
U.S.C. 7101-7352.

0
2. Amend Sec.  38.2 by:
0
a. Revising paragraphs (a)(1) through (a)(5) and (a)(7) through (a)(11)
as set forth below.
0
b. Amending paragraph (b) to add the phrase ``(713) 356-0060, http://
www.naesb.org'' after the phrase ``77002'' and adding ``(202) 502-
8371'' after the phrase ``20426.''

Sec.  38.2  Incorporation by reference of North American Energy
Standards Board Wholesale Electric Quadrant standards.

    (a) * * *
    (1) Open Access Same-Time Information Systems (OASIS), Version 1.5
(WEQ-001, Version 002.1, March 11, 2009, with minor corrections applied
May 29, 2009 and September 8, 2009, with the exception of Standards
001-0.1, 001-0.9 through 001-0.13, 001-1.0, 001-9.7, 001-14.1.3, and
001-15.1.2);
    (2) Open Access Same-Time Information Systems (OASIS) Standards &
Communication Protocols, Version 1.5 (WEQ-002, Version 002.1, March 11,
2009, with minor corrections applied May 29, 2009 and September 8,
2009);
    (3) Open Access Same-Time Information Systems (OASIS) Data
Dictionary, Version 1.5 (WEQ-003, Version 002.1, March 11, 2009, with
minor corrections applied May 29, 2009 and September 8, 2009);
    (4) Coordinate Interchange (WEQ-004, Version 002.1, March 11, 2009,
with minor corrections applied May 29, 2009 and September 8, 2009);
    (5) Area Control Error (ACE) Equation Special Cases (WEQ-005,
Version 002.1, March 11, 2009, with minor corrections applied May 29,
2009 and September 8, 2009);
* * * * *
    (7) Inadvertent Interchange Payback (WEQ-007, Version 002.1, March
11, 2009, with minor corrections applied May 29, 2009 and September 8,
2009);
    (8) Transmission Loading Relief--Eastern Interconnection (WEQ-008,
Version 002.1, March 11, 2009, with minor corrections applied May 29,
2009 and September 8, 2009);

    (9) Gas/Electric Coordination (WEQ-011, Version 002.1, March 11,
2009, with minor corrections applied May 29, 2009 and September 8,
2009);
    (10) Public Key Infrastructure (PKI) (WEQ-012, Version 002.1, March
11, 2009, with minor corrections applied May 29, 2009 and September 8,
2009); and
    (11) Open Access Same-Time Information Systems (OASIS)
Implementation Guide, Version 1.5 (WEQ-013, Version 002.1, March 11,
2009, with minor corrections applied May 29, 2009 and September 8,
2009).
* * * * *
[FR Doc. E9-28619 Filed 12-2-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 188 (Friday, October 1, 2021)]
[Rules and Regulations]
[Pages 54377-54379]
[FR Doc No: 2021-21346]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R02-OAR-2021-0263; FRL-8943-02-R2]

Approval of Air Quality Implementation Plans; New York; 2011
Periodic Emission Inventory SIP for the Ozone Nonattainment Areas

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is approving a State
Implementation Plan (SIP) revision submitted by the New York State
Department of Environmental Conservation (NYSDEC). The SIP revision
consists of the following: 2011 calendar year ozone precursor emission
inventory for volatile organic compounds (VOCs), oxides of nitrogen
(NOX), and carbon monoxide (CO) for the New York portion of
the New York-Northern New Jersey-Long Island, Connecticut NY-NJ-CT area
(New York Metropolitan Area, or NYMA) classified as serious ozone
nonattainment for the 2008 8-hour ozone National Ambient Air Quality
Standards (NAAQS or standard); and the Jamestown (Chautauqua County)
ozone nonattainment area classified as marginal for the 2008 8-hour
ozone standard. In addition, the SIP revision also consists of the 2011
calendar year statewide periodic emission inventory for volatile
organic compounds, oxides of nitrogen, and carbon monoxide. This action
is being taken in accordance with the Clean Air Act (CAA).

DATES: This final rule is effective on November 1, 2021.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R02-OAR-OAR-2021-0263. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g.,
confidential business information (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 through https://www.regulations.gov, or please
contact the person identified in the FOR FURTHER INFORMATION CONTACT
section for additional availability information.

FOR FURTHER INFORMATION CONTACT: Ysabel Banon, Air Programs Branch,
Environmental Protection Agency, Region 2 Office, 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. Background and Purpose
II. Response to Comments
III. Final Action
IV. Statutory and Executive Order Reviews

I. Background and Purpose

    On July 1, 2021 (86 FR 35030), the EPA published a notice of
proposed rulemaking (NPRM) for the New York State Implementation Plan
submitted on November 13, 2017. The NPRM proposed approval of the 2011
calendar year ozone season daily and annual ozone precursor emission
inventory for carbon monoxide (CO), oxides of nitrogen
(NOX), and volatile organic compounds (VOCs) for the New
York portion of New York-New Jersey-Long Island NY-NJ-CT (NYMA) serious

nonattainment area; and for the Jamestown, NY marginal nonattainment
area. In addition, the NPRM proposed approval of the 2011 calendar year
ozone emission inventory that was developed statewide for New York.
    The pollutants included in the inventory are annual emissions for
CO, NOX, and VOC. These submittals were made, in part to
meet requirements for serious areas for the 2008 ozone national ambient
air quality standard (NAAQS). Other specific requirements of New York's
SIP revisions for the 2008 ozone NAAQS and the rationale for the EPA's
proposed action are explained in the NPRM and will not be restated
here.

II. Response to Comments

    The EPA did not receive any comments on the July 1, 2021 NPRM.

III. Final Action

    The EPA is approving revisions to the New York SIP which pertains
to the following: 2011 calendar year ozone season daily and annual
ozone precursor emission inventories for CO, NOX, and VOC
for the NYMA portion of New York-New Jersey-Long Island NY-NJ-CT
serious nonattainment area, and for the Jamestown marginal
nonattainment area. In addition, the EPA is approving the 2011 calendar
year ozone emissions inventory that was developed statewide for New
York. The pollutants included in the inventory are annual emissions for
CO, NOX, and VOC.

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this proposed 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 proposed action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735 (October 4, 1993)) and 13563 (76 FR 3821 (January 21, 2011));
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255 (August 10, 1999));
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR 19885
(April 23, 1997));
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355 (May 22, 2001));
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide the 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, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249 (November 9,
2000)).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by November 30, 2021. 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, Carbon monoxide,
Incorporation by reference, Nitrogen dioxide, Ozone, Reporting and
recordkeeping requirements, Volatile organic compounds.

    Dated: September 27, 2021.
Walter Mugdan,
Acting Regional Administrator, EPA Region 2.
    Part 52 of chapter I, title 40 of the Code of Federal Regulations
is amended 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 HH--New York

0
2. Section 52.1670 is amended in paragraph (e) by adding the entries
``2011 base year emissions inventory,'' ``2011 VOC, NOX and
CO ozone summer season and annual emission inventory,'' and ``2011 VOC,
NOX and CO ozone summer season and annual emission
inventory'' to the end of the table to read as follows:

Sec.  52.1670   Identification of plan.

* * * * *
    (e) * * *

                      EPA--Approved New York Nonregulatory and Quasi-Regulatory Provisions
----------------------------------------------------------------------------------------------------------------
                                        Applicable         New York
        Action/SIP element             geographic or       submittal     EPA approval date       Explanation
                                    nonattainment area       date
----------------------------------------------------------------------------------------------------------------

                                                * * * ```* * * *
2011 base year emissions           State-wide..........   11/13/2017   10/1/2021, [insert     Full
 inventory.                                                             Federal Register      approval.
                                                                        citation].           The
                                                                                inventory contains
                                                                                point, nonpoint,
                                                                                nonroad, on-road
                                                                                and biogenic
                                                                                source data.
2011 VOC, NOX and CO ozone summer  New York portion of    11/13/2017   10/1/2021, [insert     Full
 season and annual emission         the New York-                       Federal Register      approval.
 inventory..                        Northern New Jersey-                citation].           The
                                    Long Island NY-NJ-                                        inventory contains
                                    CT 8-hour serious                                         point, nonpoint,
                                    ozone nonattainment                                       nonroad, on-road
                                    area.                                                     and biogenic
                                                                                source data.
2011 VOC, NOX and CO ozone summer  Jamestown 8-hour       11/13/2017   10/1/2021, [insert     Full
 season and annual emission         marginal ozone                      Federal Register      approval.
 inventory..                        nonattainment area.                 citation].           The
                                                                                inventory contains
                                                                                point, nonpoint,
                                                                                nonroad, on-road
                                                                                and biogenic
                                                                                source data.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2021-21346 Filed 9-30-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: August 30, 2006 (Volume 71, Number 168)]
[Notices]
[Page 51596]
[DOCID:fr30au06-79]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-200-010]

Rockies Express Pipeline LLC; Notice of Compliance Filing

August 22, 2006.
    Take notice that on August 16, 2006, Rockies Express Pipeline LLC
(REX) tendered for filing as part of its FERC Gas Tariff, First Revised
Volume No. 1, Sixth Revised Sheet No. 22 and First Revised Sheet No.
24, to be effective August 17, 2006.
    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing will be considered by the
Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding. Such protests
must be filed in accordance with the provisions of Section 154.210 of
the Commission's regulations (18 CFR 154.210). Anyone filing a protest
must serve a copy of that document on all the parties to the
proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons

unable to file electronically should submit an original and 14 copies
of the protest to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-14386 Filed 8-29-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 148 (Wednesday, August 1, 2012)]
[Notices]
[Pages 45621-45622]
[FR Doc No: 2012-18772]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0776]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Reclassification Petitions for
Medical Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Reclassification Petitions for
Medical Devices'' has been approved by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On March 29, 2012, the Agency submitted a
proposed collection of information entitled ``Reclassification
Petitions for Medical Devices'' to OMB for review

and clearance under 44 U.S.C. 3507. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
OMB has now approved the information collection and has assigned OMB
control number 0910-0138. The approval expires on June 30, 2015. A copy
of the supporting statement for this information collection is
available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: July 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18772 Filed 7-31-12; 8:45 am]
BILLING CODE 4160-01-P


MEMORANDUM

DATE:	November 20, 2014

TO:	Carbon Power Plan for Existing Power Plants; Docket ID: OAR-2013-0602

FROM:	Rob Lawrence EPA/Region 6/PD

SUBJECT:	June 27, 2014 Brief Remarks Regarding the Proposed Carbon Power Plan for Existing Power Plants at the meeting of the Environmental Section of the Dallas Bar Association

SUMMARY

Brief remarks (part of a larger priorities presentation) were made by EPA at the meeting of the Environmental Section of the Dallas Bar Association on the proposed Carbon Power Plan for Existing Power Plants, which was proposed on June 2, 2014.

ATTENDEES

Large group setting

EPA Participant:	Cheryl Seager (Deputy Regional Counsel)


[Federal Register Volume 77, Number 239 (Wednesday, December 12, 2012)]
[Notices]
[Pages 74004-74006]
[FR Doc No: 2012-29983]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2012-0892; FRL-9761-4]

Human Studies Review Board; Notification of a Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The EPA Office of the Science Advisor announces a public
meeting of the Human Studies Review Board to advise the Agency on the
EPA scientific and ethical reviews of research with human subjects.

DATES: This public meeting will be held on January 17, 2013, from
approximately 1:00 p.m. to approximately 4:30 p.m. Eastern Time.
Comments may be submitted on or before noon (Eastern Time) on Thursday,
January 10, 2013.

ADDRESSES: Submit your written comments, identified by Docket ID No.
EPA-HQ-ORD-2012-0892, by one of the following methods:
    Internet: http://www.regulations.gov: Follow the online
instructions for submitting comments.
    Email<EMAIL_ADDRESS>    Mail: The EPA Docket Center EPA/DC, ORD Docket, Mail code: 28221T,
1200 Pennsylvania Avenue NW., Washington, DC 20460.
    Hand Delivery: The EPA/DC Public Reading Room is located in the EPA
Headquarters Library, Room Number 3334 in the EPA West Building, at
1301 Constitution Avenue NW., Washington, DC 20460. The hours of
operation are 8:30 a.m. to 4:30 p.m. Eastern Time, Monday through
Friday, excluding federal holidays. Please call<PHONE_NUMBER> or email
the ORD Docket at<EMAIL_ADDRESS>for instructions. Updates to
Public Reading Room access are available on the Web site http://www.epa.gov/epahome/dockets.htm.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2012-0892. The Agency's policy is that all comments received will be
included in the public docket without change and may be made available
online at http://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be Confidential Business Information or other information the
disclosure of which is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through http://www.regulations.gov or email. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an email comment directly to the EPA without
going through http://www.regulations.gov, your email address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, the EPA recommends that you include your
name and other contact information in the body of your comment and with
any electronic storage media you submit. If the EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, the EPA may not be able to consider your comment.
Electronic files should avoid the use of special characters, any form
of encryption, and be free of any defects or viruses.

FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes to
receive further information should contact Jim Downing at telephone
number<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>or Lu-Ann Kleibacker on telephone number (202) 564-
7189; fax<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
mailing address Environmental Protection Agency, Office of the Science
Advisor, Mail code 8105R, 1200 Pennsylvania Avenue NW., Washington, DC
20460. General information concerning the EPA HSRB can be found on the
EPA Web site at http://www.epa.gov/osa/hsrb/.

SUPPLEMENTARY INFORMATION:
    Location: The meeting will be held at the EPA Conference Center--
Lobby Level, One Potomac Yard (South Building), 2777 S. Crystal Drive,
Arlington, VA 22202.
    Meeting access: Seating at the meeting will be on a first-come
basis. To request accommodation of a disability, please contact the
persons listed under FOR FURTHER INFORMATION CONTACT at least ten
business days prior to the meeting using the information under FOR
FURTHER INFORMATION CONTACT, so that appropriate arrangements can be
made.
    Procedures for providing public input: Interested members of the
public may submit relevant written or oral comments for the HSRB to
consider during the advisory process. Additional information concerning
submission of relevant written or oral comments is provided in Section
I, ``Public Meeting'' under subsection D. ``How May I Participate in
this Meeting?'' of this notice.

I. Public Meeting

A. Does this action apply to me?

    This action is directed to the public in general. This Notice may,
however, be of particular interest to persons who conduct or assess
human studies, especially studies on substances regulated by the EPA,
or to persons who are, or may be required to conduct testing of
chemical substances under the Federal Food, Drug, and Cosmetic Act

or the Federal Insecticide, Fungicide, and Rodenticide Act. This notice
might also be of special interest to participants of studies involving
human subjects, or representatives of study participants or experts on
community engagement. Since many entities may also be interested, the
Agency has not attempted to describe all the specific entities that may
be affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult Jim
Downing or Lu-Ann Kleibacker listed under FOR FURTHER INFORMATION
CONTACT.

B. How can I access electronic copies of this document and other
related information?

    In addition to using regulations.gov, you may access this Federal
Register document electronically through the EPA Internet under the
``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the ORD Docket, EPA/
DC, Public Reading Room. The EPA/DC Public Reading Room is located in
the EPA Headquarters Library, Room Number 3334 in the EPA West
Building, at 1301 Constitution Avenue NW., Washington, DC 20460. The
hours of operation are 8:30 a.m. to 4:30 p.m. Eastern Time, Monday
through Friday, excluding federal holidays. Please call<PHONE_NUMBER>
or email the ORD Docket at<EMAIL_ADDRESS>for instructions. Updates
to Public Reading Room access are available on the Web site (http://www.epa.gov/epahome/dockets.htm). The Agency's position paper(s),
charge/questions to the HSRB, and the meeting agenda will be available
by the last week of December 2012. In addition, the Agency may provide
additional background documents as the materials become available. You
may obtain electronic copies of these documents, and certain other
related documents that might be available electronically, from the
regulations.gov Web site and the EPA HSRB Web site at http://www.epa.gov/osa/hsrb/. For questions on document availability, or if
you do not have access to the Internet, consult either Jim Downing or
Lu-Ann Kleibacker listed under FOR FURTHER INFORMATION CONTACT.

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

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data that you
used to support your views.
    4. Provide specific examples to illustrate your concerns and
suggest alternatives.
    5. To ensure proper receipt by the EPA, be sure to identify the
Docket ID number assigned to this action in the subject line on the
first page of your response. You may also provide the name, date, and
Federal Register citation.

D. How may I participate in this meeting?

    You may participate in this meeting by following the instructions
in this section. To ensure proper receipt by the EPA, it is imperative
that you identify Docket ID number EPA-HQ-ORD-2012-0892 in the subject
line on the first page of your request.
    1. Oral comments. Requests to present oral comments will be
accepted up to Thursday, January 10, 2013. To the extent that time
permits, interested persons who have not pre-registered may be
permitted by the Chair of the HSRB to present oral comments at the
meeting. Each individual or group wishing to make brief oral comments
to the HSRB is strongly advised to submit their request (preferably via
email) to Jim Downing or Lu-Ann Kleibacker, under FOR FURTHER
INFORMATION CONTACT no later than noon, Eastern Time, Thursday, January
10, 2013, in order to be included on the meeting agenda and to provide
sufficient time for the HSRB Chair and HSRB Designated Federal Official
to review the meeting agenda to provide an appropriate public comment
period. The request should identify the name of the individual making
the presentation and the organization (if any) the individual will
represent. Oral comments before the HSRB are generally limited to five
minutes per individual or organization. Please note that this includes
all individuals appearing either as part of, or on behalf of, an
organization. While it is our intent to hear a full range of oral
comments on the science and ethics issues under discussion, it is not
our intent to permit organizations to expand the time limitations by
having numerous individuals sign up separately to speak on their
behalf. If additional time is available, further public comments may be
possible.
    2. Written comments. Submit your written comments prior to the
meeting. For the Board to have the best opportunity to review and
consider your comments as it deliberates on its report, you should
submit your comments at least five business days prior to the beginning
of this meeting. If you submit comments after this date, those comments
will be provided to the Board members, but you should recognize that
the HSRB members may not have adequate time to consider those comments
prior to making a decision. Thus, if you plan to submit written
comments, the agency strongly encourages you to submit such comments no
later than noon, Eastern Time, Thursday, January 10, 2013. You should
submit your comments using the instructions in Section I., under
subsection C., ``What Should I Consider as I Prepare My Comments for
the EPA?'' In addition, the agency also requests that persons
submitting comments directly to the docket also provide a copy of their
comments to Jim Downing or Lu-Ann Kleibacker listed under FOR FURTHER
INFORMATION CONTACT. There is no limit on the length of written
comments for consideration by the HSRB.

E. Background

    The HSRB is a Federal advisory committee operating in accordance
with the Federal Advisory Committee Act 5 U.S.C. App.2 Sec.  9. The
HSRB provides advice, information, and recommendations to the EPA on
issues related to scientific and ethical aspects of human subjects
research. The major objectives of the HSRB are to provide advice and
recommendations on: (1) Research proposals and protocols; (2) reports
of completed research with human subjects; and (3) how to strengthen
EPA's programs for protection of human subjects of research. The HSRB
reports to the EPA Administrator through the Agency's Science Advisor.
    1. Topic for discussion. At its meeting on January 17, 2013, EPA's
Human Studies Review Board will consider scientific and ethical issues
surrounding this topic:
    a. A completed study report from the Antimicrobial Exposure
Assessment Task Force II (AEATF) in which the dermal and inhalation
exposure of professional janitorial workers was

monitored as they poured liquid antimicrobial pesticide products from
conventional or reduced-splash containers into different sizes and
types of source containers. EPA seeks the advice of the HSRB on the
scientific soundness of this completed research and on its
appropriateness for use in estimating exposure that results from
pouring liquid antimicrobial pesticide products. EPA also seeks the
advice of the HSRB on whether available information supports a
determination that the study was conducted in substantial compliance
with subparts K and L of 40 CFR Part 26.
    2. Meeting minutes and reports. Minutes of the meeting, summarizing
the matters discussed and recommendations, if any, made by the advisory
committee regarding such matters, will be released within 90 calendar
days of the meeting. Such minutes will be available at http://www.epa.gov/osa/hsrb/ and http://www.regulations.gov. In addition,
information regarding the Board's final meeting report, will be found
at http://www.epa.gov/osa/hsrb/ or from the person listed under FOR
FURTHER INFORMATION CONTACT.

    Dated: December 3, 2012.
Glenn Paulson,
Science Advisor.
[FR Doc. 2012-29983 Filed 12-11-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 249 (Thursday, December 29, 2022)]
[Rules and Regulations]
[Pages 80040-80042]
[FR Doc No: 2022-28166]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 888

[Docket No. FDA-2022-N-3144]

Medical Devices; Orthopedic Devices; Classification of the
Resorbable Implant for Anterior Cruciate Ligament (ACL) Repair

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
classifying the resorbable implant for anterior cruciate ligament (ACL)
repair into class II (special controls). The special controls that
apply to the device type are identified in this order and will be part
of the codified language for the resorbable implant for ACL repair's
classification. We are taking this action because we have determined
that classifying the device into class II (special controls) will
provide a reasonable assurance of safety and effectiveness of the
device. We believe this action will also enhance patients' access to
beneficial innovative devices.

DATES: This order is effective December 29, 2022. The classification
was applicable on December 16, 2020.

FOR FURTHER INFORMATION CONTACT: Pooja Panigrahi, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4572, Silver Spring, MD 20993-0002, 240-
402-1090, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the resorbable implant for ACL
injuries as class II (special controls), which we have determined will
provide a reasonable assurance of safety and effectiveness. In
addition, we believe this action will enhance patients' access to
beneficial innovation, in part by placing the device into a lower
device class than the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device
that does not require premarket approval. We determine whether a new
device is substantially equivalent to a predicate device by means of
the procedures for premarket notification under section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act (21 U.S.C. 360c(f)(2)). Section 207 of the Food and Drug
Administration Modernization Act of 1997 (Pub. L. 105-115) established
the first procedure for De Novo classification. Section 607 of the Food
and Drug Administration Safety and Innovation Act (Pub. L. 112-144)
modified the De Novo application process by adding a second procedure.
A device sponsor may utilize either procedure for De Novo
classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    When FDA classifies a device into class I or II via the De Novo
process, the device can serve as a predicate for future devices of that
type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C
Act). As a result, other device sponsors do not have to submit a De
Novo request or premarket approval application in order to market a
substantially equivalent device (see 21 U.S.C. 360c(i), defining
``substantial equivalence''). Instead, sponsors can use the less-
burdensome 510(k) process, when necessary, to market their device.

II. De Novo Classification

    On June 4, 2020, FDA received Miach Orthopaedics, Inc.'s request
for De Novo classification of the BEAR[supreg] (Bridge-Enhanced ACL
Repair) Implant. FDA reviewed the request in order to classify the
device under the criteria for classification set forth in section
513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C.

360c(a)(1)(B)). After review of the information submitted in the
request, we determined that the device can be classified into class II
with the establishment of special controls. FDA has determined that
these special controls, in addition to the general controls, will
provide reasonable assurance of the safety and effectiveness of the
device.
    Therefore, on December 16, 2020, FDA issued an order to the
requester classifying the device into class II. In this final order,
FDA is codifying the classification of the device by adding 21 CFR
888.3044.\1\ We have named the generic type of device resorbable
implant for ACL repair, and it is identified as a degradable material
that allows for healing of a torn ACL that is biomechanically
stabilized by traditional suturing procedures. The device is intended
to protect the biological healing process from the surrounding
intraarticular environment and not intended to replace biomechanical
fixation via suturing. This classification includes devices that bridge
or surround the torn ends of a ruptured ACL.
---------------------------------------------------------------------------

    \1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
---------------------------------------------------------------------------

    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

 Table 1--Resorbable Implant for Anterior Cruciate Ligament (ACL) Repair
                      Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Repaired ACL has inadequate durability,  Animal testing, Clinical
 leading to re-tear.                      performance testing, and
                                          Labeling.
Repaired ACL is loose or functionally    Clinical performance testing.
 limited, leading to joint instability.
ACL does not heal due to inadequate      Non-clinical performance
 resorption or migration of implant.      testing and Animal testing.
Adverse tissue reaction................  Biocompatibility evaluation and
                                          Labeling.
Infection..............................  Sterilization validation, Shelf-
                                          life testing, and Labeling.
Febrile response due to endotoxins.....  Pyrogenicity testing.
Implant is incompatible with other ACL   Non-clinical performance
 repair instrumentation and sutures,      testing and Labeling.
 leading to inability to complete
 surgery.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. In order for a device to fall
within this classification, and thus avoid automatic classification in
class III, it would have to comply with the special controls named in
this final order. The necessary special controls appear in the
regulation codified by this order. We encourage sponsors to consult
with us if they wish to use a non-animal testing method they believe is
suitable, adequate, validated, and feasible. We will consider if such
an alternative method could be assessed for equivalency to an animal
test method. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections
of information in 21 CFR part 860, subpart D regarding De Novo
classification have been approved under OMB control number 0910-0844;
the collections of information in 21 CFR part 814, subparts A through
E, regarding premarket approval, have been approved under OMB control
number 0910-0231; the collections of information in part 807, subpart
E, regarding premarket notification submissions, have been approved
under OMB control number 0910-0120; the collections of information in
21 CFR part 820, regarding quality system regulation, have been
approved under OMB control number 0910-0073; and the collections of
information in 21 CFR part 801, regarding labeling, have been approved
under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 888

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
888 is amended as follows:

PART 888--ORTHOPEDIC DEVICES

0
1. The authority citation for part 888 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  888.3044 to subpart D to read as follows:

Sec.  888.3044  Resorbable implant for anterior cruciate ligament (ACL)
repair.

    (a) Identification. A resorbable implant for anterior cruciate
ligament (ACL) repair is a degradable material that allows for healing
of a torn ACL that is biomechanically stabilized by traditional
suturing procedures. The device is intended to protect the biological
healing process from the surrounding intraarticular environment and not
intended to replace biomechanical fixation via suturing. This
classification includes devices that bridge or surround the torn ends
of a ruptured ACL.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Clinical performance testing must demonstrate that the device
performs as intended under anticipated conditions of use and include
the following:
    (i) Post-operative evaluation of knee pain and function; and
    (ii) Durability as assessed by re-tear or re-operation rate.
    (2) Animal performance testing must demonstrate that the device
performs as intended under anticipated conditions of use and include
the following:
    (i) Device performance characteristics, including resorption and
ligament healing at repair site; and

    (ii) Adverse effects as assessed by gross necropsy and
histopathology.
    (3) Non-clinical testing must demonstrate that the device performs
as intended under anticipated conditions of use and include the
following:
    (i) Characterization of materials, including chemical composition,
resorption profile, and mechanical properties; and
    (ii) Simulated use testing, including device preparation, device
handling, compatibility with other ACL repair instrumentation, and user
interface.
    (4) The device must be demonstrated to be biocompatible.
    (5) Performance data must demonstrate the device to be sterile and
non-pyrogenic.
    (6) Performance data must support the shelf life of the device by
demonstrating continued sterility, package integrity, and device
functionality over the identified shelf life.
    (7) Labeling must include the following:
    (i) Identification of device materials and specifications;
    (ii) A summary of the clinical performance testing conducted with
the device;
    (iii) Instructions for use, including compatibility with other ACL
repair instrumentation or devices;
    (iv) Warnings regarding post-operative rehabilitation requirements;
and
    (v) A shelf life.

    Dated: December 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-28166 Filed 12-28-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 152 (Tuesday, August 7, 2012)]
[Rules and Regulations]
[Pages 46932-46935]
[FR Doc No: 2012-18578]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-1322; Directorate Identifier 2011-NM-211-AD;
Amendment 39-17141; AD 2012-15-12]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for all The
Boeing Company Model 767 airplanes. This AD was prompted by reports of
cracks of the underwing longeron fittings in the wing center section.
This AD requires repetitive inspections of the underwing longeron
fitting for cracking, and related investigative and corrective actions
if necessary. We are issuing this AD to detect and correct such
cracking, which could result in loss of the primary load path between
the fuselage and the wing box, and consequent catastrophic damage to
the wing box and failure of the wing.

DATES: This AD is effective September 11, 2012.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of September 11,
2012.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management, P.
O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; phone: 206-544-
5000, extension 1; fax:<PHONE_NUMBER>; Internet: https://www.myboeingfleet.com. You may review copies of the referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, Washington. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.

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 AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (phone:<PHONE_NUMBER>) is Document Management Facility,
U.S. Department of Transportation, Docket Operations, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Berhane Alazar, Aerospace Engineer,
Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office
(ACO), 1601 Lind Avenue SW., Renton, Washington 98057-3356; phone: 425-
917-6577; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM published in the Federal Register on December 19, 2011 (76 FR
78574). That NPRM proposed to require repetitive high frequency eddy
current (HFEC) inspections of the underwing longeron fitting for
cracking, and related investigative and corrective actions if
necessary.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the proposal
(76 FR 78574, December 19, 2011), and the FAA's response to each
comment.

Request To Use Revised Service Information

    Boeing, UPS, and United Airlines (United) requested that the NPRM
(76 FR 78574, December 19, 2011) use the revised service information,
which is Boeing Alert Service Bulletin 767-57A0126, Revision 2, dated
March 12, 2012. (The NPRM referred to Boeing Alert Service Bulletin
767-57A0126, dated August 12, 2011, as revised by Boeing Service
Bulletin 767-57A0126, Revision 1, dated November 9, 2011, as the
appropriate source of service information for accomplishing the
proposed requirements.) Boeing stated that the correction of the
airplane variable effectivity table does not change the intent of the
NPRM, because applicability paragraph (c) of the NPRM states that
``This AD applies to all The Boeing Company Model 767-200, -300, -300F
and -400ER series airplanes; certified in any category.'' Boeing also
stated that including Boeing Alert Service Bulletin 767-57A0126,
Revision 2, dated March 12, 2012, in the AD might prevent confusion for
operators of these airplanes.
    We agree with this request because Boeing Alert Service Bulletin
767-57A0126, Revision 2, dated March 12, 2012, clarifies inspection
areas and

corrects various typographical errors. Since the NPRM (76 FR 78574,
December 19, 2011) applied to all Model 767-200, -300, -300F and -400ER
series airplanes, the corrected effectivity in Boeing Alert Service
Bulletin 767-57A0126, Revision 2, dated March 12, 2012, does not affect
the applicability of this AD. We have changed the final rule to
reference Boeing Alert Service Bulletin 767-57A0126, Revision 2, dated
March 12, 2012. We have also added new paragraph (i) to the final rule
to give credit for actions accomplished before the effective date of
this AD using Boeing Alert Service Bulletin 767-57A0126, dated August
12, 2011, as revised by Boeing Service Bulletin 767-57A0126, Revision
1, dated November 9, 2011, and re-identified subsequent paragraphs
accordingly.

Request To Address Effects of NPRM (76 FR 78574, December 19, 2011) on
Winglets

    Aviation Partners Boeing (APB) commented that it has reviewed the
NPRM (76 FR 78574, December 19, 2011), and Boeing Alert Service
Bulletin 767-57A0126, dated August 12, 2011, and has determined that
the installation of winglets, per Supplemental Type Certificate (STC)
ST01920SE, ``does not affect them.'' We infer that APB means the
installation of these winglets does not affect accomplishing the NPRM.
    American Airlines (American) stated that the NPRM (76 FR 78574,
December 19, 2011) does not refer to any effects this inspection or
potential repair would have on aircraft equipped with APB winglets.
American stated that the NPRM should include a reference to procedures
or subsequent actions which may need to be taken over and above the
repair, if a repair was to be installed on an airplane with such
winglets.
    We agree that the AD should clarify procedures to address these APB
winglets. We have added new Note 1 to paragraph (c) of this AD to state
that installation of STC ST01920SE (http://rgl.faa.gov/Regulatory-and-
Guidance-Library/rgstc.nsf/0/082838ee177dbf62862576a4005cdfc0/$FILE/
ST01920SE.pdf) does not affect the ability to accomplish the actions
required by this AD. Therefore, for airplanes on which STC ST01920SE is
installed, a ''change in product'' AMOC approval request is not
necessary to comply with the requirements of 14 CFR 39.17. For all
other AMOC requests, the operator must request approval according to
paragraph (j) of this AD.

Request To Increase Compliance Times

    United suggested the initial inspection compliance time of within
3,000 flight cycles or 7,000 flight hours, whichever occurs first, for
airplanes that have accumulated over 70,000 total flight hours but less
than 20,000 total flight cycles, be to changed to within 6,000 flight
cycles or 14,000 flight hours, whichever occurs first. United also
stated that, as an alternative for any airplane with less than 20,000
total flight cycles and less than 90,000 total flight hours, the
initial inspection threshold of ``within 3,000 flight cycles'' be
imposed. United stated that imposing the 3,000-flight-cycle or 7,000-
flight-hour compliance times, whichever occurs first, might be more
suitable for those airplanes with very high flight cycles, such as over
30,000 or 35,000 total flight cycles.
    United stated it has reviewed its maintenance history and the most
recent inspection results of maintenance planning data (MPD) structural
tasks (53-622-00 and 53-632-00) on four of its high-time airplanes.
United stated it had no findings, and based on its maintenance history,
it considers the initial inspection threshold of 7,000 flight hours or
3,000 flight cycles, whichever occurs first, on any airplane with more
than 70,000 total flight hours to be overly aggressive for those
operators, like United, that fly airplanes on long routes with very few
flight cycles. With average flight hours of approximately 4,500 and
approximately 650 flight cycles per year, United stated that the 7,000-
flight-hour initial inspection threshold will provide only an
approximate 18-month window of opportunity to accomplish the initial
inspection on many of its airplanes. United asserts that the 18-month
threshold does not provide enough time to schedule this inspection on
this many airplanes at a heavy maintenance environment, which is when
it should be accomplished.
    We do not agree, because fatigue analysis is based on statistical
methods. Statistics from four airplanes using only the MPD general
visual inspections, without the benefit of an HFEC inspection, does not
provide sufficient statistical justification to increase the compliance
time. In developing an appropriate compliance time for this AD, we
considered the unsafe condition as well as the recommendations of the
manufacturer, and the practical aspect of accomplishing the required
inspection within an interval of time that corresponds to the normal
maintenance schedules of most affected operators. We have not changed
the final rule in this regard.

Request To Revise On-Condition Costs

    UPS stated that the estimated on-conditions parts cost specified in
the NPRM (76 FR 78574, December 19, 2011) only reflect the cost for one
wing.
    We agree. We have confirmed that one top-kit is required for each
wing, and that the parts costs for both wings ranges up to $14,290. We
have revised the estimated on-condition costs in the final rule to
include the cost required for both wings.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
the AD with the changes described previously and minor editorial
changes. We have determined that these minor changes:
     [Agr]re consistent with the intent that was proposed in
the NPRM (76 FR 78574, December 19, 2011) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (76 FR 78574, December 19, 2011).
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of the AD.

Interim Action

    We consider this AD interim action. The design approval holder is
currently developing a modification that will address the unsafe
condition identified in this AD. Once this modification is developed,
approved, and available, we might consider additional rulemaking.

Costs of Compliance

    We estimate that this AD affects 417 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
              Action                    Labor cost        Parts cost      Cost per product        operators
----------------------------------------------------------------------------------------------------------------
Repetitive HFEC inspection.......  3 work-hours x $85               $0  $255 per inspection  $106,335 per
                                    per hour = $255                      cycle.               inspection cycle.
                                    per inspection
                                    cycle.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary inspections and
replacements that would be required based on the results of the
inspection. We have no way of determining the number of aircraft that
might need these on-condition actions.

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
             Action                  Labor cost                Parts cost                 Cost per product
----------------------------------------------------------------------------------------------------------------
Tension bolt hole and front      104 work-hours x    Up to $14,290................  Up to $23,130.
 spar lower chord HFEC            $85 per hour =
 inspection and fitting           $8,840.
 replacement.
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that would enable us to provide
cost estimates for cracking repairs specified in this 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

    This AD will not have federalism implications under Executive Order
13132. This AD will 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 that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (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.

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

0
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]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2012-15-12 The Boeing Company: Amendment 39-17141; Docket No. FAA-
2011-1322; Directorate Identifier 2011-NM-211-AD.

(a) Effective Date

    This AD is effective September 11, 2012.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all The Boeing Company Model 767-200, -300, -
300F, and -400ER series airplanes, certificated in any category.

    Note 1 to paragraph (c) of this AD: Installation of Supplemental
Type Certificate (STC) ST01920SE (http://rgl.faa.gov/Regulatory--
and--Guidance--Library/rgstc.nsf/0/082838ee177dbf62862576a4005cdfc0/
$FILE/ST01920SE.pdf) does not affect the ability to accomplish the
actions required by this AD. Therefore, for airplanes on which STC
ST01920SE is installed, a ''change in product'' alternative method
of compliance (AMOC) approval request is not necessary to comply
with the requirements of 14 CFR 39.17.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 57, Wings.

(e) Unsafe Condition

    This AD was prompted by reports of cracks of the underwing
longeron fittings in the wing center section. We are issuing this AD
to detect and correct such cracking, which could result in loss of
the primary load path between the fuselage and the wing box, and
consequent catastrophic damage to the wing box and failure of the
wing.

(f) Compliance

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

(g) Inspections, Related Investigative Actions, and Corrective Actions

    Except as provided by paragraphs (h)(2) and (h)(3) of this AD,
at the applicable compliance time specified in paragraph 1.E.,
``Compliance,'' of Boeing Alert Service Bulletin 767-57A0126,
Revision 2, dated March 12, 2012: Do a high frequency eddy current
(HFEC) inspection to detect cracking of the underwing longeron
fitting; and do all applicable related investigative and corrective
actions; in accordance with the Accomplishment Instructions of
Boeing Alert Service Bulletin 767-57A0126, Revision 2, dated March
12, 2012, except as provided by paragraph (h)(1) of this AD. Do all
applicable related investigative and corrective actions before
further flight. Repeat the inspection of the underwing longeron
fitting thereafter at the applicable compliance time and intervals
specified in paragraph 1.E., ``Compliance,'' of Boeing Alert Service
Bulletin 767-57A0126, Revision 2, dated March 12, 2012.

(h) Exceptions to Paragraph (g) of This AD

    (1) If, during accomplishment of the related investigative
action required by this AD, any cracking is found and Boeing Alert
Service Bulletin 767-57A0126, Revision 2, dated March 12, 2012,
specifies to contact Boeing for repair instructions: Before further
flight, do the repair using a method approved in accordance with the
procedures specified in paragraph (j) of this AD.
    (2) Where Paragraph 1.E., ``Compliance,'' of Boeing Alert
Service Bulletin 767-57A0126, Revision 2, dated March 12, 2012,
specifies a compliance time ``after the original issue date of this
service bulletin,'' this AD requires compliance within the specified
compliance time ``after the effective date of this AD.''
    (3) The Condition column of Paragraph 1.E., ``Compliance,'' of
Boeing Alert Service Bulletin 767-57A0126, Revision 2, dated March
12, 2012, refers to total flight cycles and total flight hours ``as
of the original issue date of this service bulletin.'' However, this
AD applies to the airplanes with the specified total flight cycles
or total flight hours ``as of the effective date of this AD.''

(i) Credit for Previous Actions

    This paragraph provides credit for the actions required by
paragraph (g) of this AD, if those actions were performed before the
effective date of this AD using Boeing Alert Service Bulletin 767-
57A0126, dated August 12, 2011, as revised by Boeing Service
Bulletin 767-57A0126, Revision 1, dated November 9, 2011; both of
which are not incorporated by reference.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (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.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Seattle ACO to make
those findings. For a repair method to be approved, the repair must
meet the certification basis of the airplane, and the approval must
specifically refer to this AD.

(k) Related Information

    For more information about this AD, contact Berhane Alazar,
Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft
Certification Office (ACO), 1601 Lind Avenue SW., Renton, Washington
98057-3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the following service
information under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use the following service information to do the
actions required by this AD, unless the AD specifies otherwise.
    (i) Boeing Alert Service Bulletin 767-57A0126, Revision 2, dated
March 12, 2012.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; phone: 206-
544-5000, extension 1; fax:<PHONE_NUMBER>; Internet: https://www.myboeingfleet.com.
    (4) You may review copies of the referenced service information
at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW.,
Renton, Washington. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.
    (5) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on July 23, 2012.
Kalene C. Yanamura,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-18578 Filed 8-6-12; 8:45 am]
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