[Federal Register Volume 81, Number 132 (Monday, July 11, 2016)]
[Notices]
[Pages 44872-44873]
[FR Doc No: 2016-16353]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]

Controlling the Progression of Myopia: Contact Lenses and Future
Medical Devices; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

SUMMARY: The Food and Drug Administration (FDA), in cosponsorship with
the American Academy of Ophthalmology (AAO), American Academy of
Optometry (AAOpt), American Association for Pediatric Ophthalmology and
Strabismus (AAPOS), American Optometric Association (AOA), American
Society of Cataract and Refractive Surgery (ASCRS), and Contact Lens
Association of Ophthalmologists, Inc. (CLAO) is announcing a public
workshop entitled ``Controlling the Progression of Myopia: Contact
Lenses and Future Medical Devices.'' The purpose of this workshop is to
discuss the increasing prevalence of myopia, as well as suggested
clinical trial design attributes for studies using contact lenses or
other medical devices to control the progression of myopia.

DATES: The public workshop will be held on September 30, 2016, from 8
a.m. to 6 p.m. Pickup of materials will begin at 7:30 a.m.

ADDRESSES: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31, Conference Center, the
Great Room, (Rm. 1503), Silver Spring, MD, 20993. Entrance for the
public workshop participants (non-FDA employees) is through Building 1
where routine security check procedures will be performed. For parking
and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Michelle Tarver, Office of Device
Evaluation, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2504, Silver
Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The prevalence of myopia in the United States has increased over
the past decade with approximately 24 percent (over 30 million) of
adults over 40 years of age being affected. Recent studies have found
the overall prevalence of myopia to be 1.2 percent among non-Hispanic
White children, 6.6 percent in African Americans, 3.7 percent in
Hispanic, and 3.98 percent in Asian children. Pathologic myopia is the
third most frequent cause of blindness due to retinal detachments or
abnormal blood vessel growth. Given these potentially poor outcomes
with high myopia, researchers have sought ways to prevent its
development by starting interventions in childhood. The literature
suggests that myopia progression is most rapid between 6 and 11 years
of age and manipulating peripheral retinal image quality may be a
treatment strategy to control axial length and therefore the
progression of myopia. The results of studies conducted with
specialized contact lenses, both rigid and soft, have indicated that
this approach may reduce the rate of myopic progression in children. As
research into myopia control is continuing at a rapid pace,
accompanying potential safety and effectiveness questions also have
emerged. To ensure that the studies conducted provide information that
can adequately inform the regulatory review, we are conducting a
workshop to answer questions about the appropriate clinical trial
design and outcomes for these devices.

II. Topics for Discussion at the Public Workshop

    Topics to be discussed at the public workshop include, but are not
limited to the following topics:
     Myopia Demographics.
     Contact Lens Use and Safety in a Pediatric Population.
     Contact Lens Behaviors and Hygiene.
     Studies Conducted on Myopia Control Devices and Their
Challenges.
     Regulation of Contact Lenses (Ref. 1).
     Patient/Caregiver Perspectives and the Role in Trial
Design and Conduct (Refs. 2 and 3).
    We will also have a panel discussion to address questions related
to the design of these clinical trials.

    Registration: Registration is $250 for members of AAO, AAOpt,
AAPOS, AOA, ASCRS, or CLAO; and $400 for non-members and available on a
first-come, first-served basis. Persons interested in attending this
public workshop must register online. The deadline for online
registration is September 23, 2016, at 4 p.m. EDT. There will be no
onsite registration on the day of the public workshop. Early
registration is recommended because facilities are limited and,
therefore, FDA may limit the number of participants from each
organization.
    If you need special accommodations due to a disability, please
contact Ms. Susan Monahan at<EMAIL_ADDRESS>or<PHONE_NUMBER>
no later than September 16, 2016.
    To register for the public workshop, please visit http://www.cfom.info/meetings/myopia/. Please provide complete contact
information for each attendee, including name, title, affiliation,
address, email, telephone number, and membership in the cosponsoring
organizations. If there are any questions with registration, please
contact Mrs. Bobbi Hahn at<EMAIL_ADDRESS>Registrants will receive
confirmation after they have been accepted. You will be notified if you
are on a waiting list.
    Food may be purchased in advance for $45 on the registration Web
site (http://www.cfom.info/meetings/myopia/). Food and beverages will
also be available for purchase by participants during the workshop
breaks.
    For more information on the workshop, please see the FDA's Medical
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
(Select this public workshop from the posted events list.) Those
without Internet access should contact Bobbi Hahn to register at 651-
731-7257.
    Streaming Webcast of the Public Workshop: The public workshop will
also be Webcast. Persons interested in viewing the Webcast must
register online by September 23, 2016. Early registration is
recommended because Webcast connections are limited. Organizations are
requested to register all participants, but to view using one
connection per location. Webcast participants will be sent technical
system requirements after registration and will be sent connection
access information after September 23, 2016. If you have never attended
a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a
quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. FDA has verified the Web site addresses in this
document, as of the date this document publishes in the Federal
Register, but Web sites are subject to change over time.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management, Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. The Freedom of
Information office address is available on the Agency's Web site at
http://www.fda.gov. A link to the transcript will also be available
approximately 45 days after the public workshop on the Internet at
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list).

III. References

    The following references are on display in the Division of Dockets
Management (see Transcripts) and are available for viewing by
interested persons between 9 a.m. and 4 p.m., Monday through Friday;
they are also available electronically at http://www.regulations.gov.
FDA has verified the Web site addresses, as of the date this document
publishes in the Federal Register, but Web sites are subject to change
over time.

1. Premarket Notification [510(k)] Guidance Document for Class II
Daily Wear Contact Lenses. U.S. Department of Health and Human
Services, Food and Drug Administration. May 1994. http://www.fda.gov/RegulatoryInformation/Guidances/ucm080928.htm.
2. Guidance for Industry: Patient-Reported Outcome Measures: Use in
Medical Product Development to Support Labeling Claims. U.S.
Department of Health and Human Services, Food and Drug
Administration. December 2009. http://www.fda.gov/downloads/Drugs/.../Guidances/UCM193282.pdf.
3. Draft Guidance: Patient Preference Information--Submission,
Review in PMAs, HDE Applications, and De Novo Requests, and
Inclusion in Device Labeling. U.S. Department of Health and Human
Services, Food and Drug Administration. Posted March 2015. http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm446680.pdf.

    Dated: July 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16353 Filed 7-8-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: March 9, 2010 (Volume 75, Number 45)]
[Notices]
[Page 10846]
[DOCID:fr09mr10-98]

=======================================================================
-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

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

Extension: Rule 31; SEC File No. 270-537; OMB Control No. 3235-0597.
    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Section 31 of the Securities Exchange Act of 1934 (15 U.S.C. 78ee)
(``Exchange Act'') requires the Commission to collect fees and
assessments from national securities exchanges and national securities
associations (collectively, ``self-regulatory organizations'' or
``SROs'') based on the volume of their securities transactions. To
collect the proper amounts, the Commission adopted Rule 31 (17 CFR
240.31) and Form R31 (17 CFR 249.11) under the Exchange Act whereby the
SROs must report to the Commission the volume of their securities
transaction and the Commission, based on that data, calculates the
amount of fees and assessments that the SROs owe pursuant to Section
31. Rule 31 and Form R31 require the SROs to provide this data on a
monthly basis.
    The Commission estimates that each respondent makes 12 such filings
on an annual basis at an average hourly burden of approximately 1.47
hours per response. Currently, there are 16 respondents. However, based
on past experience, the Commission is estimating an increase to 18
respondents, including 13 national securities exchanges, two security
futures exchanges, and one national securities association subject to
the collection of information requirements of Rule 31 and two
registered clearing agencies are required to provide certain data in
their possession needed by the SROs to complete Form R31. The
Commission estimates that the total burden for all 18 respondents is
318 hours (12 filings/respondent per year x 1.47 hours/filing x 18
respondents = 317.52; rounded to 318 hours) per year.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimate of the burden of the proposed collection of information; (c)
ways to enhance the quality, utility, and clarity of the information to
be collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    Please direct your written comments to: Charles Boucher, Director/
Chief Information Officer, Securities and Exchange Commission, c/o
Shirley Martinson, 6432 General Green Way, Alexandria, Virginia, 22312
or by sending an email to<EMAIL_ADDRESS>
    Dated: March 2, 2010.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-4914 Filed 3-8-10; 8:45 am]
BILLING CODE 8011-01-P


throughout the world. As a result, engine manufacturers respond to this
market reality by designing and building engines that conform to ICAO
international standards and practices. This normal business practice
means that engine manufacturers are compelled to make the necessary
business decisions and investments to maximize their international
markets even in the absence of U.S. regulations that would otherwise
codify ICAO standards and practices. Indeed, engine manufacturers have
developed or are already developing improved technology in response to
ICAO standards that match the standards being promulgated in this final
rule. Also, the recommended practices, e.g., test procedures, needed to
demonstrate compliance are being adhered to by manufacturers during
current engine certification tests, or will be even in the absence this
final rule. Therefore, EPA believes that today's standards and
practices that conform with ICAO standards and practices will impose no
real additional burden on engine manufacturers. This finding regarding
no incremental burden, is also consistent with past EPA rulemakings
that adopted ICAO requirements. ((See 62 FR 25356 (May 8, 1997) and 70
FR 69664 (November 11, 2005).
    In fact, engine manufacturers have suggested that certain benefits
accrue for compliant products when the U.S. adopts ICAO standards and
practices, but have not provided detailed information regarding these
benefits. Primarily, such action makes FAA certification more
straightforward and transparent. That in turn is advantageous when
marketing their products to potential customers, because compliance
with ICAO standards is an important consideration in purchasing
decisions. It simply removes any question that their engines comply
with international requirements. There will be some cost, however,
associated with our annual reporting requirement for emission related
information. (See section III.D for a description of the reports.)
There are a total of 10 engine manufacturers that would be affected.
Eight of these produce turbofan engines with rated thrusts greater than
26.7 kN, which are already voluntarily reported to the ICAO-related
Emissions Databank (EDB).\107\ We expect the incremental reporting
burden for these manufacturers to be very small because we: (1) Have
significantly reduced the number of reporting elements from those
requested in the EDB, and (2) are adding only three basic reporting
categories to those already requested by the EDB. Also, four of the
eight manufacturers make smaller turbofan and turboprop engines that
will be reporting for the first time. This will add a small incremental
burden for these four manufacturers that otherwise already voluntarily
report to the EDB. There are also two engine manufacturers that only
produce turbofan engines with rated thrusts less than or equal to 26.7
kN and they will be reporting for the first time. For these two
manufacturers we believe that the reporting burden will be small
because all of the information we are requiring should be readily
available, and these manufacturers have a very limited number of engine
models.
---------------------------------------------------------------------------

    \107\ As discussed in section III.D, we are requiring a single
report that integrates the new reporting requirement contained in
this final rule with the existing mandatory greenhouse gas (GHG)
reporting of NOX and CO2 as already required
under Sec.  87.64. Combining the existing GHG report with the new
reporting requirement will not increase an engine manufacturer's
reporting burden. A single, integrated report may actually reduce a
manufacturer's total reporting burden somewhat because of the
efficiency inherent in reporting to EPA once instead of twice.
---------------------------------------------------------------------------

    We have estimated the annual burden and cost to be about six hours
and $365 per manufacturer. With 10 manufacturers submitting reports,
the total burden of this reporting requirement is estimated to be 60
hours, for a total cost of $3,646.

VII. Consultation With FAA

    The requirements contained in this action were developed in
consultation with the Federal Aviation Administration (FAA). Section
231(a)(2)(B)(i) of the CAA requires EPA to ``consult with the
Administrator of the [FAA] on aircraft engine emission standards'' 42
U.S.C. 7571(a)(2)(B)(i), and section 231(a)(2)(B)(ii) indicates that
EPA ``shall not change the aircraft engine emission standards if such
change would significantly increase noise. * * *'' 42 U.S.C.
7571(a)(2)(B)(ii). Section 231(b) of the CAA states that ``[a]ny
regulation prescribed under this section (and any revision thereof)
shall take effect after such period as the Administrator finds
necessary (after consultation with the Secretary of Transportation) to
permit the development and application of the requisite technology,
giving appropriate consideration to the cost of compliance within such
period.'' 42 U.S.C. 7571(b). Section 231(c) provides that any
regulation under section 231 ``shall not apply if disapproved by the
President * * * on the basis of a finding by the Secretary of
Transportation that any such regulation would create a hazard to
aircraft safety.'' 42 U.S.C. 7571(c). Under section 232 of the CAA, the
Department of Transportation (DOT) has the responsibility to enforce
the aircraft emission standards established by EPA

under section 231.\108\ As in past rulemakings and pursuant to the
above referenced sections of the CAA, EPA has coordinated with the FAA,
i.e., DOT, with respect to today's action.
---------------------------------------------------------------------------

    \108\ The functions of the Secretary of Transportation under
part B of title II of the Clean Air Act (Sec. Sec.  231-234, 42
U.S.C. 7571-7574) have been delegated to the Administrator of the
FAA. 49 CFR 1.47(g).
---------------------------------------------------------------------------

    Moreover, FAA is the official U.S. delegate to ICAO. FAA agreed to
the amendments at ICAO's Sixth and Eighth Meetings of the Committee on
Aviation Environmental Protection (CAEP/6) after advisement from
EPA.\109\ FAA and EPA were both members of the CAEP's Working Group 3
(among others), whose objective was to evaluate emissions technical
issues and develop recommendations on such issues for CAEP/6 and CAEP/
8. After assessing emissions test procedure amendments and new
NOX standards, Working Group 3 made recommendations to CAEP
on these elements. These recommendations were approved by CAEP/6
meetings prior to their adoption by ICAO in 2004. Similarly, the more
recent Working Group 3 recommendations were approved by CAEP/8 and have
been adopted ICAO.
---------------------------------------------------------------------------

    \109\ The Sixth Meeting of CAEP (CAEP/6) occurred in Montreal,
Quebec from February 2 through 12 in 2004.
---------------------------------------------------------------------------

    In addition, as discussed above, FAA will have the duty to enforce
today's requirements. As a part of these duties, the FAA witnesses the
emission tests or delegates aspects of that responsibility to the
engine manufacturer, which is then monitored by the FAA.

VIII. Public Participation

    We proposed this regulation on July 27, 2011 (76 FR 45012). A
public hearing was held on August 11, 2011 in Chicago, IL. The public
was invited to submit written comments on the proposal during the
formal comment period, which ended on September 26, 2011. We received
eight public comments from aircraft and aircraft engine manufacturers,
airline operators and an individual.
    The vast majority of commenters supported the central tenets of the
proposed regulations. That is, there was broad support for the adoption
of these standards and the alignment of U.S. and international
emissions regulations. We received specific comments on several aspects
of the proposal.
    Throughout this notice, we discussed the key issues arising from
the public comment and our responses. In addition, we have addressed
all of the public comments in the analysis of comments document
associated with this final action and located in the docket (Docket ID
EPA-HQ-OAR-2010-0687).

IX. Statutory Provisions and Legal Authority

    The statutory authority for today's proposal is provided by
sections 114, 231-234 and 301(a) of the Clean Air Act, as amended, 42
U.S.C. Sec. Sec.  7414, 7571-7574 and 7601(a). See section II of
today's rule for discussion of how EPA meets the CAA's statutory
requirements.

X. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review, and Executive
Order 13563: Improving Regulation and Regulatory Review

    Under Executive Order (EO) 12866 (58 FR 51735, October 4, 1993),
this action is a ``significant regulatory action.'' This action
promulgates new aircraft engine emissions regulations and as such,
requires consultation and coordination with the Federal Aviation
Administration (FAA). OMB has determined that this action raises ``* *
* novel legal or policy issues arising out of legal mandates, the
President's priorities, or the principles set forth in the EO.''
Accordingly, EPA submitted this action to the Office of Management and
Budget (OMB) for review under EO 12866 and 13563 (76 FR 3821, January
21, 2011) and any changes made in response to OMB recommendations have
been documented in the docket for this action.
    As discussed further in section V, we do not attribute any costs to
the compliance with today's regulations that conform to ICAO standards
and recommended practices. Aircraft turbofan engines are international
commodities. As a result, engine manufacturers respond to this market
reality by designing and building engines that conform to ICAO
international standards and practices. Therefore, engine manufacturers
are compelled to make the necessary business decisions and investments
to maximize their international markets even in the absence of U.S.
action. Indeed, engine manufacturers have or are already responding, or
will in the future, to ICAO requirements that match the standards and
practices adopted here. Therefore, EPA believes that today's
requirements that conform with ICAO standards and practices will impose
no real additional burden on engine manufacturers. This finding is also
consistent with past EPA rulemakings that adopted ICAO requirements.
    There is, nonetheless, a small burden associated with the reporting
requirements, as discussed in section IX.B.

B. Paperwork Reduction Act

    The information collection requirements in this rule have been
submitted for approval to the Office of Management and Budget (OMB)
under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. The
information collection requirements are not enforceable until OMB
approves them.
    Manufacturers keep substantial records to document their compliance
with emission standards. We need to be able to access this data to
conduct accurate emission inventories, understand how emission
standards affect the current fleet, and develop appropriate policy in
the form of future emission standards. Most manufacturers are already
accustomed to reporting much of this information to ICAO. However,
these reports are voluntary and aperiodic. As part of this action, we
are requiring that engine manufacturers send this information to EPA on
an annual basis. We are also requiring manufacturers to send us their
annual production volumes, which we would treat as confidential
business information. Under the Clean Air Act, we are authorized to
require manufacturers to establish and maintain necessary records, make
reports, and provide such other information as we may reasonably
require to execute our functions under the Act. See 42 U.S.C.
7414(a)(1). We will simply require manufacturers to add the required
information items to the annual report they are already required to
submit with information about NOX and CO2
emission levels. See section III.D for a more complete description of
the annual reporting requirement.
    We have estimated the total annual burden of the reporting
requirement to be 60 hours, and the total cost to be $3,646. The annual
burden and cost per respondent is estimated to be 6 hours and $365.
Burden is defined at 5 CFR 1320.3(b).
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in 40 CFR are listed in 40 CFR part 9. When this ICR is
approved by OMB, the Agency will publish a technical amendment to 40
CFR part 9 in the Federal Register to display the OMB control number
for the approved

information collection requirements contained in this final rule.

C. Regulatory Flexibility Analysis

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedure Act or any other statute unless the agency certifies that the
rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small organizations, and small governmental jurisdictions.
    For purposes of assessing the impacts of today's rule on small
entities, small entity is defined as: (1) A small business as defined
by SBA size standards; (2) a small governmental jurisdiction that is a
government of a city, county, town, school district or special district
with a population of less than 50,000; and (3) a small organization
that is any not-for-profit enterprise which is independently owned and
operated and is not dominant in its field. The following Table 4
provides an overview of the primary SBA small business categories
potentially affected by this regulation.

                       Table 4--Primary Potentially Affected SBA Small Business Categories
----------------------------------------------------------------------------------------------------------------
                    Industry                       NAICS a Codes      Defined by SBA as a small business if: b
----------------------------------------------------------------------------------------------------------------
Manufacturers of new aircraft engines..........             336412  <1,000 employees.
Manufacturers of new aircraft..................             336411  <1,500 employees.
----------------------------------------------------------------------------------------------------------------
a North American Industry Classification System (NAICS).
b According to SBA's regulations (13 CFR part 121), businesses with no more than the listed number of employees
  or dollars in annual receipts are considered ``small entities'' for purposes of a regulatory flexibility
  analysis.

    After considering the economic impacts of today's rule on small
entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. Small
governmental jurisdictions and small organizations as described above
will not be impacted. We have determined that the estimated effect of
the rule's reporting requirement is to affect one small entity turbofan
engine manufacturer with costs less than one percent of revenues. This
one company represents all of the small businesses affected by the
regulations. An analysis of the impacts of the proposed rule on small
businesses has been prepared and placed in the docket for this
rulemaking.\110\ Since this final rule is largely unchanged from the
proposal, that analysis remains valid for the final rule.
---------------------------------------------------------------------------

    \110\ ``Small Business Impact Memo, Proposed Aircraft Engine
Emission Standards--Determination of No SISNOSE,'' EPA memo from
Solveig Irvine to Alexander Cristofaro, November, 2010.
---------------------------------------------------------------------------

D. Unfunded Mandates Reform Act

    This rule does not contain a Federal mandate that may result in
expenditures of $100 million or more for State, local, and tribal
governments, in the aggregate, or the private sector in any one year.
As discussed in section III, today's action will establish consistency
between U.S. and existing international emission standards. The engine
manufacturers are already developing the technology to meet the
existing ICAO standards, and we do not believe it is appropriate to
attribute the costs of that technology to this action. Thus, this rule
is not subject to the requirements of sections 202 or 205 of UMRA.
    This rule is also not subject to the requirements of section 203 of
UMRA because it contains no regulatory requirements that might
significantly or uniquely affect small governments. The provisions of
this rule apply to the manufacturers of aircraft and aircraft engines,
and as such would not affect small governments.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects 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, as
specified in Executive Order 13132. As discussed earlier, section 233
of the CAA preempts states from adopting or enforcing aircraft engine
emission standards that are not identical to our standards. This rule
revises the Code of Federal Regulations to more accurately reflect the
statutory preemption established by the Clean Air Act. This rule does
not impose any new preemption of State and local law. Thus, Executive
Order 13132 does not apply to this action.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    These rules regulate aircraft manufacturers and aircraft engine
manufacturers. We do not believe that Tribes own any of these
businesses nor are there other implications for Tribes. Thus, Executive
Order 13175 does not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    This rule is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997) because it is not economically significant as defined
in EO 12866 and the Agency does not believe the environmental health
risks or safety risks addressed by this action present a
disproportionate risk to children. See section II.B.2 for a discussion
of the health impacts of NOX emissions.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355 (May 22, 2001)), because it is not
likely to have a significant adverse effect on the supply,
distribution, or use of energy. These aircraft engine emissions
regulations are not expected to result in any changes to aircraft fuel
consumption.

I. National Technology Transfer Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law 104-113 (15 U.S.C. 272 note)
directs EPA to use voluntary consensus standards in its regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures, and business practices) that are developed or adopted by
voluntary consensus standards bodies. NTTAA directs EPA to provide

Congress, through OMB, explanations when the Agency decides not to use
available and applicable voluntary consensus standards.
    This rulemaking involves technical standards for testing emissions
for aircraft gas turbine engines. EPA is using test procedures
contained in ICAO's International Standards and Recommended Practices
Environmental Protection, Annex 16, Volume II along with the
modifications contained in this rulemaking.\111\ These procedures are
currently used by all manufacturers of aircraft gas turbine engines
(with thrust greater than 26.7 kN) to demonstrate compliance with ICAO
emissions standards.
---------------------------------------------------------------------------

    \111\ ICAO International Standards and Recommended Practices
Environmental Protection, Annex 16, Volume II, ``Aircraft Engine
Emissions,'' Second Edition, July 1993--Amendment 3, March 20, 1997.
Copies of this document can be obtained from ICAO (www.icao.int).
---------------------------------------------------------------------------

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order (EO) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    EPA has determined that this rule will not have disproportionately
high and adverse human health or environmental effects on minority or
low-income populations because it increases the level of environmental
protection for all affected populations without having any
disproportionately high and adverse human health or environmental
effects on any population, including any minority or low-income
population.

K. Congressional Review Act

    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 rule 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). This rule will be effective July 18, 2012.

L. Executive Order 13609: Promoting International Regulatory
Cooperation

    Executive Order (EO) 13609 (77 FR 26413, May 4, 2012) promotes
international regulatory cooperation in order to identify approaches
that are at least as protective as those that are or would be adopted
in the absence of such cooperation in meeting shared challenges
involving health, safety, labor, security, environmental, and other
issues. International regulatory cooperation can also reduce,
eliminate, or prevent unnecessary differences in regulatory
requirements.
    These final standards are identical to the international standards
developed through EPA's active participation in the United Nation's
International Civil Aviation Organization (ICAO) activities. EPA has
historically been a principal participant in the development of U.S.
policy in various ICAO working groups and other international venues,
assisting and advising the Federal Aviation Administration on aviation
emissions, technology, and policy matters. These provisions provide a
means by which the United States can meet its obligations under the
Chicago Convention and ensure that engine manufacturers maintain
worldwide acceptability of their products.

List of Subjects

40 CFR Part 87

    Environmental protection, Air pollution control, Aircraft,
Incorporation by reference.

40 CFR Part 1068

    Environmental protection, Administrative practice and procedure,
Confidential business information, Imports, Motor vehicle pollution,
Penalties, Reporting and recordkeeping requirements, Warranties.

     Dated: June 1, 2012.
Lisa P. Jackson,
Administrator.

    For the reasons described in the preamble, title 40, chapter I, of
the Code of Federal Regulations is amended as set forth below.

PART 87--CONTROL OF AIR POLLUTION FROM AIRCRAFT AND AIRCRAFT
ENGINES

0
1. The authority citation for part 87 is revised to read as follows:

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

Subpart A--[Amended]

0
2. Revise Sec.  87.1 to read as follows:

Sec.  87.1  Definitions.

    The definitions in this section apply to this part. The definitions
apply to all subparts. Any terms not defined in this section have the
meaning given in the Clean Air Act. The definitions follow:
    Act means the Clean Air Act, as amended (42 U.S.C. 7401 et seq).
    Administrator means the Administrator of the Environmental
Protection Agency and any other officer or employee of the
Environmental Protection Agency to whom authority involved may be
delegated.
    Aircraft has the meaning given in 14 CFR 1.1, which defines
aircraft to mean a device used or intended to be used for flight in the
air. Note that under Sec.  87.3, the requirements of this part
generally apply only to propulsion engines used on certain airplanes
for which U.S. airworthiness certificates are required.
    Aircraft engine means a propulsion engine which is installed in or
which is manufactured for installation in an aircraft.
    Aircraft gas turbine engine means a turboprop, turbofan, or
turbojet aircraft engine.
    Characteristic level has the meaning given in Appendix 6 of ICAO
Annex 16 (as of July 2008). The characteristic level is a calculated
emission level for each pollutant based on a statistical assessment of
measured emissions from multiple tests.
    Class TP means all aircraft turboprop engines.
    Class TF means all turbofan or turbojet aircraft engines or
aircraft engines designed for applications that otherwise would have
been fulfilled by turbojet and turbofan engines except engines of class
T3, T8, and TSS.
    Class T3 means all aircraft gas turbine engines of the JT3D model
family.
    Class T8 means all aircraft gas turbine engines of the JT8D model
family.
    Class TSS means all aircraft gas turbine engines employed for
propulsion of aircraft designed to operate at supersonic flight speeds.
    Commercial aircraft engine means any aircraft engine used or
intended for use by an ``air carrier,'' (including those engaged in
``intrastate air transportation'') or a ``commercial

operator'' (including those engaged in ``intrastate air
transportation'') as these terms are defined in subtitle 7 of title 49
of the United States Code and title 14 of the Code of Federal
Regulations.
    Commercial aircraft gas turbine engine means a turboprop, turbofan,
or turbojet commercial aircraft engine.
    Date of introduction or introduction date means the date of
manufacture of the first individual production engine of a given engine
model or engine type certificate family to be certificated. This does
not include test engines or other engines not placed into service.
    Date of manufacture means the date on which a manufacturer is
issued documentation by FAA (or other competent authority for engines
certificated outside the United States) attesting that the given engine
conforms to all applicable requirements. This date may not be earlier
that the date on which assembly of the engine is complete. Where the
manufacturer does not obtain such documentation from FAA (or other
competent authority for engines certificated outside the United
States), date of manufacture means the date of final assembly of the
engine.
    Derivative engine for emissions certification purposes means an
engine that has the same or similar emissions characteristics as an
engine covered by a U.S. type certificate issued under 14 CFR part 33.
These characteristics are specified in Sec.  87.48.
    Designated EPA Program Officer means the Director of the Assessment
and Standards Division, 2000 Traverwood Drive, Ann Arbor, Michigan
48105.
    DOT Secretary means the Secretary of the Transportation and any
other officer or employee of the Department of Transportation to whom
the authority involved may be delegated.
    Engine means an individual engine. A group of identical engines
together make up an engine model or sub-model.
    Engine model means an engine manufacturer's designation for an
engine grouping of engines and/or engine sub-models within a single
engine type certificate family, where such engines have similar design,
including being similar with respect to the core engine and combustor
designs.
    Engine sub-model means a designation for a grouping of engines with
essentially identical design, especially with respect to the core
engine and combustor designs and other emission-related features.
Engines from an engine sub-model must be contained within a single
engine model. For purposes of this part, an original engine model
configuration is considered a sub-model. For example, if a manufacturer
initially produces an engine model designated ABC and later introduces
a new sub-model ABC-1, the engine model consists of two sub-models: ABC
and ABC-1.
    Engine type certificate family means a group of engines (comprising
one or more engine models, including sub-models and derivative engines
for emissions certification purposes of those engine models) determined
by FAA to have a sufficiently common design to be grouped together
under a type certificate.
    EPA means the U.S. Environmental Protection Agency.
    Except means to routinely allow engines to be produced and sold
that do not meet (or do not fully meet) otherwise applicable standards.
(Note that this definition applies only with respect to spare engines
and that the term ``except'' has its plain meaning in other contexts.)
Excepted engines must conform to regulatory conditions specified for an
exception in this part and other applicable regulations. Excepted
engines are deemed to be ``subject to'' the standards of this part even
though they are not required to comply with the otherwise applicable
requirements. Engines excepted with respect to certain standards must
comply with other standards from which they are not excepted.
    Exempt means to allow (through a formal case-by-case process)
engines to be produced and sold that do not meet (or do not fully meet)
otherwise applicable standards. Exempted engines must conform to
regulatory conditions specified for an exemption in this part and other
applicable regulations. Exempted engines are deemed to be ``subject
to'' the standards of this part even though they are not required to
comply with the otherwise applicable requirements. Engines exempted
with respect to certain standards must comply with other standards as a
condition of the exemption.
    Exhaust emissions means substances emitted to the atmosphere from
exhaust discharge nozzles, as measured by the test procedures specified
in subpart G of this part.
    FAA means the U.S. Department of Transportation, Federal Aviation
Administration.
    Fuel venting emissions means raw fuel, exclusive of hydrocarbons in
the exhaust emissions, discharged from aircraft gas turbine engines
during all normal ground and flight operations.
    Good engineering judgment involves making decisions consistent with
generally accepted scientific and engineering principles and all
relevant information, subject to the provisions of 40 CFR 1068.5.
    ICAO Annex 16 means Volume II of Annex 16 to the Convention on
International Civil Aviation (incorporated by reference in Sec.  87.8).
    In-use aircraft gas turbine engine means an aircraft gas turbine
engine which is in service.
    Military aircraft means aircraft owned by, operated by, or produced
for sale to the armed forces or other agency of the federal government
responsible for national security (including but not limited to the
Department of Defense) and other aircraft considered to be military
aircraft under international law and conventions.
    New means relating to an aircraft or aircraft engine that has never
been placed into service.
    Operator means any person or company that owns or operates an
aircraft.
    Production cutoff date or date of the production cutoff means the
date on which interim phase-out allowances end.
    Rated output (rO) means the maximum power/thrust available for
takeoff at standard day conditions as approved for the engine by FAA,
including reheat contribution where applicable, but excluding any
contribution due to water injection, expressed in kilowatts or
kilonewtons (as applicable) and rounded to at least three significant
figures.
    Rated pressure ratio (rPR) means the ratio between the combustor
inlet pressure and the engine inlet pressure achieved by an engine
operating at rated output, rounded to at least three significant
figures.
    Round has the meaning given in 40 CFR 1065.1001.
    Smoke means the matter in exhaust emissions that obscures the
transmission of light, as measured by the test procedures specified in
subpart G of this part.
    Smoke number means a dimensionless value quantifying smoke
emissions calculated in accordance with ICAO Annex 16.
    Spare engine means an engine installed (or intended to be
installed) on an in-service aircraft to replace an existing engine and
that is excepted as described in Sec.  87.50(c).
    Standard day conditions means the following ambient conditions:
temperature = 15 [deg]C, specific humidity = 0.00634 kg H2O/
kg dry air, and pressure = 101.325 kPa.
    Subsonic means relating to aircraft that are not supersonic
aircraft.

    Supersonic means relating to aircraft that are certificated to fly
faster than the speed of sound.
    Tier 0 means relating to an engine that is subject to the Tier 0
NOX standards specified in Sec.  87.21.
    Tier 2 means relating to an engine that is subject to the Tier 2
NOX standards specified in Sec.  87.21.
    Tier 4 means relating to an engine that is subject to the Tier 4
NOX standards specified in Sec.  87.21.
    Tier 6 means relating to an engine that is subject to the Tier 6
NOX standards specified in Sec.  87.23.
    Tier 8 means relating to an engine that is subject to the Tier 8
NOX standards specified in Sec.  87.23.
    Turbofan engine means a gas turbine engine designed to create its
propulsion from exhaust gases and from air that bypasses the combustion
process and is accelerated in a ducted space between the inner (core)
engine case and the outer engine fan casing.
    Turbojet engine means a gas turbine engine that is designed to
create all of its propulsion from exhaust gases.
    Turboprop engine means a gas turbine engine that is designed to
create most of its propulsion from a propeller driven by a turbine,
usually through a gearbox.
    Turboshaft engine means a gas turbine engine that is designed to
drive a rotor transmission system or a gas turbine engine not used for
propulsion.
    U.S.-registered aircraft means an aircraft that is on the U.S.
Registry.
    We (us, our) means the Administrator of the Environmental
Protection Agency and any authorized representatives.

0
3. Revise Sec.  87.2 to read as follows:

Sec.  87.2  Abbreviations.

    The abbreviations used in this part have the following meanings:

% percent
[deg] degree
CO carbon monoxide
CO2 carbon dioxide
g gram
HC hydrocarbon(s)
kN kilonewton
kW kilowatt
LTO landing and takeoff
NOX oxides of nitrogen
rO rated output
rPR rated pressure ratio
SN smoke number

0
4. Revise Sec.  87.3 to read as follows:

Sec.  87.3  General applicability and requirements.

    (a) The regulations of this part apply to engines on all aircraft
that are required to be certificated by FAA under 14 CFR part 33 except
as specified in this paragraph (a). These regulations do not apply to
the following aircraft engines:
    (1) Reciprocating engines (including engines used in ultralight
aircraft).
    (2) Turboshaft engines such as those used in helicopters.
    (3) Engines used only in aircraft that are not airplanes. For
purposes of this paragraph (a)(3), ``airplane'' means a fixed-wing
aircraft that is heavier than air.
    (4) Engines not used for propulsion.
    (b) Under section 232 of the Act, the Secretary of Transportation
issues regulations to ensure compliance with the standards and related
requirements of this part (42 U.S.C. 7572).
    (c) The Secretary of Transportation shall apply these regulations
to aircraft of foreign registry in a manner consistent with obligations
assumed by the United States in any treaty, convention or agreement
between the United States and any foreign country or foreign countries.
    (d) No State or political subdivision of a State may adopt or
attempt to enforce any aircraft or aircraft engine standard respecting
emissions unless the standard is identical to a standard applicable to
such aircraft under this part (including prior-tier standards
applicable to exempt engines).

Sec.  87.5  [Removed]

0
5. Remove Sec.  87.5.

0
6. Revise Sec.  87.6 to read as follows:

Sec.  87.6  Aircraft safety.

    The provisions of this part will be revised if at any time the DOT
Secretary determines that an emission standard cannot be met within the
specified time without creating a hazard to aircraft safety.

Sec.  87.7  [Removed]

0
7. Remove Sec.  87.7.

0
8. Revise Sec.  87.8 to read as follows:

Sec.  87.8  Incorporation by reference.

    (a) Certain material is incorporated by reference into this part
with the approval of the Director of the Federal Register under 5
U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other than that
specified in this section, the Environmental Protection Agency must
publish notice of change in the Federal Register and the material must
be available to the public. All approved material is available for
inspection at U.S. EPA, Air and Radiation Docket and Information
Center, 1301 Constitution Ave. NW., Room B102, EPA West Building,
Washington, DC 20460,<PHONE_NUMBER>, and is available from the sources
listed below. It is also available for inspection 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/code_of_federal_regulations/ibr_locations.html.
    (b) International Civil Aviation Organization, Document Sales Unit,
999 University Street, Montreal, Quebec, Canada H3C 5H7, (514) 954-
8022, www.icao.int, or<EMAIL_ADDRESS>    (1) Annex 16 to the Convention on International Civil Aviation,
Environmental Protection, Volume II--Aircraft Engine Emissions, Third
Edition, July 2008 (ICAO Annex 16). IBR approved for Sec. Sec.  87.1,
87.42(c), and 87.60(a) and (b).
    (2) [Reserved]

Subpart C--[Amended]

0
9. Amend Sec.  87.21 as follows:
0
a. By revising the section heading.
0
b. By adding introductory text.
0
c. By revising paragraphs (d)(1)(iii), (d)(1)(iv), (d)(1)(vi)
introductory text, (e)(1), and (f).

Sec.  87.21  Exhaust emission standards for Tier 4 and earlier engines.

    This section describes the emission standards that apply for Tier 4
and earlier engines that apply for aircraft engines manufactured before
July 18, 2012 and certain engines exempted under Sec.  87.50. Note that
the tier of standards identified for an engine relates to
NOX emissions and that the specified standards for HC, CO,
and smoke emissions apply independent of the changes to the
NOX emission standards.
    (d) * * *
    (1) * * *
    (iii) The following Tier 0 emission standard applies for engines of
a type or model of which the date of manufacture of the first
individual production model was on or before December 31, 1995 and for
which the date of manufacture of the individual engine was on or before
December 31, 1999.

Oxides of Nitrogen: (40 + 2(rPR)) grams/kilonewton rO.

    (iv) The following Tier 2 emission standard applies for engines of
a type or model of which the date of manufacture of the first
individual production model was after December 31, 1995 or for which
the date of manufacture of the individual engine was after December 31,
1999:

Oxides of Nitrogen: (32 + 1.6(rPR)) grams/kilonewton rO.
* * * * *

    (vi) The following Tier 4 emission standards apply for engines of a
type or model of which the date of manufacture of the first individual
production model was after December 31, 2003:
* * * * *
    (e) * * *
    (1) Class TF of rated output less than 26.7 kilonewtons
manufactured on or after August 9, 1985:

SN = 83.6(rO)-\0.274\ (rO is in kilonewtons) not to exceed a
maximum of SN = 50.
* * * * *
    (f) The standards in this section refer to a composite emission
sample measured and calculated in accordance with the procedures
described in subpart G of this part.

0
10. Add a new Sec.  87.23 to subpart C to read as follows:

Sec.  87.23  Exhaust emission standards for Tier 6 and Tier 8 engines.

    This section describes the emission standards that apply for Tier 6
and Tier 8 engines. The standards of this section apply for aircraft
engines manufactured on or after July 18, 2012, except where we specify
that they apply differently by year, or where the engine is exempt from
one or more standards of this section. Except as specified in paragraph
(d) of this section, these standards apply based on the date the engine
is manufactured. Where a gaseous emission standard is specified by a
formula, calculate and round the standard to three significant figures
or to the nearest 0.1 g/kN (for standards at or above 100 g/kN). Where
a smoke standard is specified by a formula, calculate and round the
standard to the nearest 0.1 SN. Engines comply with an applicable
standard if the testing results show that the engine type certificate
family's characteristic level does not exceed the numerical level of
that standard, as described in Sec.  87.60. The tier of standards
identified for an engine relates to NOX emissions and that
the specified standards for HC, CO, and smoke emissions apply
independent of the changes to the NOX emission standards.
    (a) New turboprop aircraft engines with rated output at or above
1,000 kilowatts must comply with a smoke standard of 187 [middot]
rO-0.168.
    (b) New supersonic engines must comply with the standards shown in
the following table:

                                Table 1 to Sec.   87.23--Smoke and Gaseous Emission Standards for New Supersonic Engines
--------------------------------------------------------------------------------------------------------------------------------------------------------
          Rated output                  Smoke number            HC (g/kN rated  output)        NOX (g/kN rated  output)       CO (g/kN rated  output)
--------------------------------------------------------------------------------------------------------------------------------------------------------
rO < 26.7 kN....................  ........................  140 [middot] 0.92rPR            36 + 2.42 [middot] rPR         4550 [middot] rPR-1.03
rO [gteqt] 26.7 kN..............  83.6 [middot] rO-0.274    140 [middot] 0.92rPR            36+2.42 [middot] rPR           4550 [middot] rPR-1.03
                                   or 50.0, whichever is
                                   smaller.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (c) New turbofan or turbojet aircraft engines that are installed in
subsonic aircraft must comply with the following standards:
    (1) The applicable smoke, HC, and CO standards are shown in the
following table:

       Table 2 to Sec.   87.23--Smoke, HC, and CO Standards for New Subsonic Turbofan or Turbojet Engines
----------------------------------------------------------------------------------------------------------------
                                                                               Gaseous emission standards (g/kN
                                                                                rated output)
            Rated output (kN)                        Smoke standard          -----------------------------------
                                                                                HC                CO
----------------------------------------------------------------------------------------------------------------
rO < 26.7 kN.............................  83.6 [middot] rO-0.274 or 50.0,    ................  ................
                                            whichever is smaller.
rO >= 26.7 kN............................  83.6 [middot] rO-0.274 or 50.0,                19.6               118
                                            whichever is smaller.
----------------------------------------------------------------------------------------------------------------

    (2) The Tier 6 NOX standards apply as described in this
paragraph (c)(2). See paragraph (d) of this section for provisions
related to models introduced before these standards started to apply
and engines determined to be derivative engines for emissions
certification purposes under the requirements of this part.

               Table 3 to Sec.   87.23--Tier 6 NOX Standards for New Subsonic Turbofan or Turbojet Engines With Rated Output Above 26.7 kN
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                           and the rated output (in kN)
   If the rated pressure ratio is . . .              is . . .                       The NOX emission standard (in g/kN rated output) is . . .
--------------------------------------------------------------------------------------------------------------------------------------------------------
rPR <= 30................................  26.7 < rO <= 89.............  38.5486 + 1.6823 [middot] PR-0.2453 [middot] rO-0.00308 [middot] rPR [middot]
                                                                          rO
                                           rO > 89.....................  16.72 + 1.4080 [middot] rPR
30 < rPR < 82.6..........................  26.7 < rO <= 89.............  46.1600 + 1.4286 [middot] rPR - 0.5303 [middot] rO + 0.00642 [middot] rPR
                                                                          [middot] rO
                                           rO > 89.....................  -1.04 + 2.0 [middot] rPR
rPR >= 82.6..............................  all.........................  32 + 1.6 [middot] rPR
--------------------------------------------------------------------------------------------------------------------------------------------------------

     (3) The Tier 8 NOX standards apply as described in this
paragraph (c)(3) beginning January 1, 2014. See paragraph (d) of this
section for provisions related to models introduced before January 1,
2014 apply and engines determined to be derivative engines for
emissions certification purposes under the requirements of this part.

 Table 4 to Sec.   87.23--Tier 8 NOX Standards for New Subsonic Turbofan
           or Turbojet Engines With Rated Output Above 26.7 kN
------------------------------------------------------------------------
                                                      The NOX emission
 If the rated pressure ratio  and the rated output    standard (in g/kN
          is . . .              (in kN) is . . .    rated output) is . .
                                                              .
------------------------------------------------------------------------
rPR <= 30...................  26.7 < rO <= 89.....  40.052 + 1.5681
                                                     [middot] rPR -
                                                     0.3615 [middot] rO
                                                      0.0018 [middot]
                                                     rPR [middot] rO
                              rO > 89.............  7.88 + 1.4080
                                                     [middot] rPR
30 < rPR < 104.7............  26.7 < rO <= 89.....  41.9435 + 1.505 rPR-
                                                     0.5823 [middot] rO
                                                     + 0.005562-rPR
                                                     [middot] rO
                              rO > 89.............  -9.88 + 2.0 [middot]
                                                     rPR
rPR >= 104.7................  all.................  32 + 1.6 [middot]
                                                     rPR
------------------------------------------------------------------------

     (d) This paragraph (d) specifies phase-in provisions that allow
continued production of certain engines after the Tier 6 and Tier 8
standards begin to apply.
    (1) Engine type certificate families certificated with
characteristic levels at or below the Tier 4 NOX standards
of Sec.  87.21 (as applicable based on rated output and rated pressure
ratio) and introduced before July 18, 2012 may be produced through
December 31, 2012 without meeting the Tier 6 NOX standards
of paragraph (c)(2) of this section. This also applies for engines that
are covered by the same type certificate and are determined to be
derivative engines for emissions certification purposes under the
requirements of this part. Note that after this production cutoff date
for the Tier 6 NOX standards, such engines may be produced
only if they are covered by an exemption under Sec.  87.50. This
production cutoff does not apply to engines installed (or delivered for
installation) on military aircraft.
    (2) Engine type certificate families certificated with
characteristic levels at or below the Tier 6 NOX standards
of paragraph (c)(2) of this section with an introduction date before
January 1, 2014 may continue to be produced. This also applies for
engines that are covered by the same type certificate and are
determined to be derivative engines for emissions certification
purposes under the requirements of this part.
    (3) An engine manufacturer may produce up to six newly manufactured
Tier 4 engines on or after July 18, 2012, subject to the provisions of
this paragraph (d)(3). Tier 4 engines meeting the criteria of this
paragraph (d)(3) are excepted without request from the otherwise
applicable Tier 6 NOX emission standard. To be eligible for
this exception the engines must have a date of manufacture prior to
August 31, 2013 and be fully compliant with all requirements applicable
to Tier 4 engines. The manufacturer must include these engines in the
report required by Sec.  87.50. This exception is void for any
manufacturer that produces more than six excepted engines under this
paragraph.

0
11. Add a new subpart E containing Sec. Sec.  87.40, 87.42, 87.46, and
87.48 to read as follows:
Subpart E--Certification Provisions
Sec.
87.40 General certification requirement.
87.42 Production report to EPA.
87.46 Recordkeeping.
87.48 Derivative engines for emissions certification purposes.

Subpart E--Certification Provisions

Sec.  87.40  General certification requirement.

    Manufacturers of engines subject to this part must meet the
requirements of title 14 of the Code of Federal Regulations as
applicable.

Sec.  87.42  Production report to EPA.

    Engine manufacturers must submit an annual production report as
specified in this section. This requirement applies for engines
produced on or after January 1, 2013.
    (a) You must submit the report for each calendar year in which you
produce any engines subject to emission standards under this part. The
report is due by February 28 of the following calendar year. Note that
Sec.  87.64 requires you to report CO2 emission rates to EPA
in addition to NOX. Include these data in the report
required by this section. If you produce exempted or excepted engines,
you may submit a single report with information on exempted/excepted
and normally certificated engines.
    (b) Send the report to the Designated EPA Program Officer.
    (c) In the report, specify your corporate name and the year for
which you are reporting. Include information as described in this
section for each engine sub-model subject to emission standards under
this part. List each engine sub-model produced or certificated during
the calendar year, including the following information for each sub-
model:
    (1) The type of engine (turbofan, turboprop, etc.) and complete
sub-model name, including any applicable model name, sub-model
identifier, and engine type certificate family identifier.
    (2) The certificate under which it was produced. Identify all the
following:
    (i) The type certificate number. Specify if the sub-model also has
a type certificate issued by a certificating authority other than FAA.
    (ii) Your corporate name as listed in the certificate.
    (iii) Emission standards to which the engine is certificated.
    (iv) Date of issue of type certificate (month and year).
    (v) Whether or not this is a derivative engine for emissions
certification purposes. If so, identify the original certificated
engine model.
    (vi) The engine sub-model that received the original type
certificate for an engine type certificate family.
    (3) Identify the combustor of the sub-model, where more than one
type of combustor is available.
    (4) The calendar-year production volume of engines from the sub-
model that are covered by an FAA type certificate. Record zero for sub-
models with no engines produced during the calendar year, or state that
the engine model is no longer in production and list the date of
manufacture (month and year) of the last engine produced. Specify the
number of these engines that are intended for use on new aircraft and
the number that are intended for use as non-exempt engines on in-use
aircraft. For engines delivered without a final sub-model status and
for which the manufacturer has not ascertained the engine's sub-model
when installed before submitting its production report, the
manufacturer may do any of the following in its initial report, and
amend it later:
    (i) List the sub-model that was shipped or the most probable sub-
model.
    (ii) List all potential sub-models.
    (iii) State ``Unknown Sub-Model.''
    (5) The number of engines tested and the number of test runs for
the applicable type certificate.

    (6) The applicable test data and related information specified in
Part III, Section 2.4 of ICAO Annex 16 (incorporated by reference in
Sec.  87.8), except as otherwise allowed by this paragraph. For
purposes of this paragraph (c)(6), applicable test data means data
required to certify the engine sub-model, which would typically include
NOX, HC, CO and smoke number. However, applicable test data
would not include NOX, HC, or CO emissions for engines
subject to only smoke standards. Note that Sec.  87.64 also requires
you to report CO2 emissions. Specify thrust in kW for
turboprop engines. You may omit the following items specified in Part
III, Section 2.4 of ICAO Annex 16:
    (i) Fuel specifications including fuel specification reference and
hydrogen/carbon ratio.
    (ii) Methods used for data acquisition, correcting for ambient
conditions, and data analysis.
    (iii) Intermediate emission indices and rates, however you may not
omit the final characteristic level for each regulated pollutant in
units of g/kN or g/kW.
    (d) Clearly show what information you consider confidential by
marking, circling, bracketing, stamping, or some other method. We will
store your confidential information as described in 40 CFR part 2.
Also, we will disclose it only as specified in 40 CFR part 2. If you
send us information without claiming it is confidential, we may make it
available to the public without further notice to you, as described in
40 CFR 2.204.
    (e) Include the following signed statement and endorsement by an
authorized representative of your company: ``We submit this report
under 40 CFR 87.42. All the information in this report is true and
accurate to the best of my knowledge.''
    (f) Where information provided for the previous year remains valid
and complete, you may report your production volumes and state that
there are no changes, without resubmitting the other information
specified in this section.

Sec.  87.46  Recordkeeping.

    (a) You must keep a copy of any reports or other information you
submit to us for at least three years.
    (b) Store these records in any format and on any media, as long as
you can promptly send us organized, written records in English if we
ask for them. You must keep these records readily available. We may
review them at any time.

Sec.  87.48  Derivative engines for emissions certification purposes.

    (a) General. A type certificate holder may request from the FAA a
determination that an engine configuration is considered a derivative
engine for emissions certification purposes. This would mean that the
engine configuration is determined to be similar in design to a
previously certificated engine (the ``original'' engine) for purposes
of compliance with exhaust emission standards (gaseous and smoke). In
order for the engine configuration to be considered a derivative engine
for emission purposes under this part, it must have been derived from
an original engine that was certificated to the requirements of 14 CFR
part 33, and one of the following conditions must be met:
    (1) The FAA determined that a safety issue exists that requires an
engine modification.
    (2) Emissions from the derivative engines are determined to be
similar. In general, this means the emissions must meet the criteria
specified in paragraph (b) of this section. FAA may adjust these
criteria in unusual circumstances, consistent with good engineering
judgment.
    (3) All of the regulated emissions from the derivative engine are
lower than the original engine.
    (b) Emissions similarity. (1) The type certificate holder must
demonstrate that the proposed derivative engine model's emissions meet
the applicable standards and differ from the original model's emission
rates only within the following ranges:
    (i) 3.0 g/kN for NOX.
    (ii) 1.0 g/kN for HC.
    (iii) 5.0 g/kN for CO.
    (iv) 2.0 SN for smoke.
    (2) If the characteristic level of the original certificated engine
model (or any other sub-models within the emission type certificate
family tested for certification) before modification is at or above 95%
of the applicable standard for any pollutant, you must measure the
proposed derivative engine model's emissions for all pollutants to
demonstrate that the derivative engine's resulting characteristic
levels will not exceed the applicable emission standards. If the
characteristic levels of the originally certificated engine model (and
all other sub-models within the emission type certificate family tested
for certification) are below 95% of the applicable standard for each
pollutant, then, you may use engineering analysis to demonstrate that
the derivative engine will not exceed the applicable emission
standards, consistent with good engineering judgment. The engineering
analysis must address all modifications from the original engine,
including those approved for previous derivative engines.
    (c) Continued production allowance. Where we allow continued
production of an engine model after new standards begin to apply, you
may also produce engine derivatives if they conform to the
specifications of this section.
    (d) Non-derivative engines. If the FAA determines that an engine
model does not meet the requirements for a derivative engine for
emissions certification purposes, the type certificate holder is
required to demonstrate that the engine complies with the emissions
standards applicable to a new engine type.

0
12. Add a new subpart F containing Sec.  87.50 to read as follows:

Subpart F--Exemptions and Exceptions

Sec.  87.50  Exemptions and exceptions.

    This section specifies provisions related to exempting/excepting
engines from some or all of the standards and requirements of this part
87. Exempted/excepted engines must conform to regulatory conditions
specified for an exemption in this section and other applicable
regulations. Exempted/excepted engines are deemed to be ``subject to''
the standards of this part even though they are not required to comply
with the otherwise applicable requirements. Engines exempted/excepted
with respect to certain standards must comply with other standards.
Exemption requests under paragraph (a) of this section must be approved
by the FAA, with the written concurrence of EPA, to be effective.
Exemption requests under paragraph (b) of this section must be approved
only by the FAA to be effective. Exceptions do not require a case-by-
case FAA approval.
    (a) Engines installed in new aircraft. Type certificate holders may
request an exemption to produce a limited number of newly manufactured
engines through December 31, 2016, to be installed in new aircraft as
specified in this paragraph (a). This exemption is limited to
NOX emissions from engines that are covered by a valid type
certificate issued by FAA.
    (1) Submit your request for an exemption to the FAA before
producing the engines to be exempted, who will provide a copy to the
Designated EPA Program Officer. Exemption by an authority outside the
United States does not satisfy this requirement. Unless EPA and FAA
allow otherwise, all requests must include the following:

    (i) Your corporate name and an authorized representative's contact
information.
    (ii) A description of the engines for which you are requesting the
exemption including the type certificate number and date it was issued
by the FAA. Include in your description the engine model and sub-model
names and the types of aircraft in which the engines are expected to be
installed. Specify the number of engines that you would produce under
the exemption and the period during which you would produce them.
    (iii) Information about the aircraft in which the engines will be
installed. Specify the airframe models and expected first purchasers/
users of the aircraft. Identify all countries in which you expect the
aircraft to be registered. Specify how many aircraft will be registered
in the United States and how many will be registered in other
countries; you may estimate this if it is not known.
    (iv) A justification of why the exemption is appropriate.
Justifications must include a description of the environmental impact
of granting the exemption. Include other relevant information such as
the following:
    (A) Technical issues, from an environmental and airworthiness
perspective, which may have caused a delay in compliance with a
production cutoff.
    (B) Economic impacts on the manufacturer, operator(s), and aviation
industry at large.
    (C) Environmental effects. This should consider the amount of
additional air pollutant emissions that will result from the exemption.
This could include consideration of items such as:
    (1) The amount that the engine model exceeds the standard, taking
into account any other engine models in the engine type certificate
family covered by the same type certificate and their relation to the
standard.
    (2) The amount of the applicable air pollutant that would be
emitted by an alternative engine for the same application.
    (3) The impact of changes to reduce the applicable air pollutant on
other environmental factors, including emission rates of other air
pollutants, community noise, and fuel consumption.
    (4) The degree to which the adverse impact would be offset by
cleaner engines produced in the same time period (unless we decide to
consider earlier engines).
    (D) Impact of unforeseen circumstances and hardship due to business
circumstances beyond your control (such as an employee strike, supplier
disruption, or calamitous events).
    (E) Projected future production volumes and plans for producing a
compliant version of the engine model in question.
    (F) Equity issues in administering the production cutoff among
economically competing parties.
    (G) List of other certificating authorities from which you have
requested (or expect to request) exemptions, and a summary of the
request.
    (H) Any other relevant factors.
    (v) A statement signed by your authorized representative attesting
that all information included in the request is accurate.
    (2) In consultation with the EPA, the FAA may specify additional
conditions for the exemption.
    (3) You must submit the annual report specified in paragraph (d) of
this section.
    (4) The permanent record for each engine exempted under this
paragraph (a) must indicate that the engine is an exempted new engine.
    (5) Engines exempted under this paragraph (a) must be labeled with
the following statement: ``EXEMPT NEW''.
    (6) You must notify the FAA if you determine after submitting your
request that the information is not accurate, either from an error or
from changing circumstances. If you believe the new or changed
information could have affected approval of your exemption (including
information that could have affected the number of engines we exempt),
you must notify the FAA promptly. The FAA will consult with EPA as
needed to address any concerns related to this new or corrected
information.
    (b) Temporary exemptions based on flights for short durations at
infrequent intervals. The emission standards of this part do not apply
to engines which power aircraft operated in the United States for short
durations at infrequent intervals. Such operations are limited to:
    (1) Flights of an aircraft for the purpose of export to a foreign
country, including any flights essential to demonstrate the integrity
of an aircraft prior to its flight to a point outside the United
States.
    (2) Flights to a base where repairs, alterations or maintenance are
to be performed, or to a point of storage, and flights for the purpose
of returning an aircraft to service.
    (3) Official visits by representatives of foreign governments.
    (4) Other flights the Secretary determines to be for short
durations at infrequent intervals. A request for such a determination
shall be made before the flight takes place.
    (c) Spare engines. Newly manufactured engines meeting the
definition of ``spare engine'' are excepted as follows:
    (1) This exception allows production of a newly manufactured engine
for installation on an in-service aircraft. It does not allow for
installation of a spare engine on a new aircraft.
    (2) Each spare engine must be identical to a sub-model previously
certificated to meet all requirements applicable to Tier 4 engines or
later requirements.
    (3) Spare engines excepted under this paragraph (c) may be used
only where the emissions of the spare engines are certificated to equal
to or lower emission standards than those of the engines they are
replacing, for all regulated pollutants.
    (4) No prior approval is required to produce spare engines. Engine
manufacturers must include information about their production of spare
engines in the annual report specified in paragraph (d) of this section
    (5) The permanent record for each engine excepted under this
paragraph (c) must indicate that the engine was produced as an excepted
spare engine.
    (6) Engines excepted under this paragraph (c) must be labeled with
the following statement: ``EXCEPTED SPARE''.
    (d) Annual reports. If you produce engines with an exemption/
exception under this section, you must submit an annual report with
respect to such engines.
    (1) You must send the Designated EPA Program Officer a report
describing your production of exempted/excepted engines for each
calendar year in which you produce such engines by February 28 of the
following calendar year. You may include this information in the
certification report described in Sec.  87.42. Confirm that the
information in your initial request is still accurate, or describe any
relevant changes.
    (2) Provide the information specified in this paragraph (d)(2). For
purposes of this paragraph (d), treat spare engine exceptions separate
from other new engine exemptions. Include the following for each
exemption/exception and each engine model and sub-model:
    (i) Engine model and sub-model names.
    (ii) Serial number of each engine.
    (iii) Use of each engine (for example, spare or new installation).

    (iv) Types of aircraft in which the engines were installed (or are
intended to be installed for spare engines).
    (v) Serial number of the new aircraft in which engines are
installed (if known), or the name of the air carriers (or other
operators) using spare engines.
    (3) Include information in the report only for engines having a
date of manufacture within the specific calendar year.

Subpart G--Test Procedures

0
13. The heading for subpart G is revised as set forth above.

0
14. Revise Sec.  87.60 to read as follows:

Sec.  87.60  Testing engines.

    (a) Use the equipment and procedures specified in Appendix 3,
Appendix 5, and Appendix 6 of ICAO Annex 16 (incorporated by reference
in Sec.  87.8), as applicable, to demonstrate whether engines meet the
gaseous emission standards specified in subpart C of this part. Measure
the emissions of all regulated gaseous pollutants. Similarly, use the
equipment and procedures specified in Appendix 2 and Appendix 6 of ICAO
Annex 16 to determine whether engines meet the smoke standard specified
in subpart C of this part. The compliance demonstration consists of
establishing a mean value from testing some number of engines, then
calculating a ``characteristic level'' by applying a set of statistical
factors that take into account the number of engines tested. Round each
characteristic level to the same number of decimal places as the
corresponding emission standard. For turboprop engines, use the
procedures specified for turbofan engines, consistent with good
engineering judgment.
    (b) Use a test fuel meeting the specifications described in
Appendix 4 of ICAO Annex 16 (incorporated by reference in Sec.  87.8).
The test fuel must not have additives whose purpose is to suppress
smoke, such as organometallic compounds.
    (c) Prepare test engines by including accessories that are
available with production engines if they can reasonably be expected to
influence emissions. The test engine may not extract shaft power or
bleed service air to provide power to auxiliary gearbox-mounted
components required to drive aircraft systems.
    (d) Test engines must reach a steady operating temperature before
the start of emission measurements.
    (e) In consultation with the EPA, the FAA may approve alternate
procedures for measuring emissions as specified in this paragraph (e).
This might include testing and sampling methods, analytical techniques,
and equipment specifications that differ from those specified in this
part. Manufacturers and operators may request this approval by sending
a written request with supporting justification to the FAA and to the
Designated EPA Program Officer. Such a request may be approved only if
one of the following conditions is met:
    (1) The engine cannot be tested using the specified procedures.
    (2) The alternate procedure is shown to be equivalent to or better
(e.g., more accurate or precise) than the specified procedure.
    (f) The following landing and take-off (LTO) cycles apply for
emission testing and calculating weighted LTO values:

                                                        Table 1 to Sec.   87.60--LTO Test Cycles
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Turboprop                   Subsonic turbofan              Supersonic turbofan
                                                        ------------------------------------------------------------------------------------------------
                          Mode                             Percent of     Time in mode     Percent of     Time in mode     Percent of      Time in mode
                                                          rated output      (minutes)     rated output      (minutes)     rated output      (minutes)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Take-off...............................................             100             0.5             100             0.7             100              1.2
Climb..................................................              90             2.5              85             2.2              65              2.0
Descent................................................  ..............  ..............  ..............  ..............              15              1.2
Approach...............................................              30             4.5              30             4.0              34              2.3
Taxi/ground idle.......................................               7            26.0               7            26.0             5.8             26.0
--------------------------------------------------------------------------------------------------------------------------------------------------------

     (g) Engines comply with an applicable standard if the testing
results show that the engine type certificate family's characteristic
level does not exceed the numerical level of that standard, as
described in Sec.  87.60.

Sec. Sec.  87.61-87.63  [Removed]

0
15. Remove Sec. Sec.  87.61-87.63.

Sec.  87.64  [Amended]

0
16. In Sec.  87.64, remove and reserve paragraph (a).

Sec. Sec.  87.65-87.71  [Removed]

0
17. Remove Sec. Sec.  87.65-87.71.

Subpart H--[Removed]

0
18. Remove subpart H.

PART 1068--GENERAL COMPLIANCE PROVISIONS FOR HIGHWAY, STATIONARY,
AND NONROAD PROGRAMS

0
19. The authority citation for part 1068 continues to read as follows:

    Authority:  42 U.S.C. 7401-7671q.

Subpart A--[Amended]

0
20. Amend Sec.  1068.1 by revising paragraph (b) to read as follows:

Sec.  1068.1  Does this part apply to me?

* * * * *
    (b) This part does not apply to any of the following engine or
vehicle categories:
    (1) Light-duty motor vehicles (see 40 CFR part 86).
    (2) Heavy-duty motor vehicles and motor vehicle engines, except as
specified in 40 CFR part 86.
    (3) Aircraft engines, except as specified in 40 CFR part 87.
    (4) Land-based nonroad compression-ignition engines we regulate
under 40 CFR part 89.
    (5) Small nonroad spark-ignition engines we regulate under 40 CFR
part 90.
    (6) Marine spark-ignition engines we regulate under 40 CFR part 91.
    (7) Locomotive engines we regulate under 40 CFR part 92.
    (8) Marine compression-ignition engines we regulate under 40 CFR
parts 89 or 94.
* * * * *
[FR Doc. 2012-13828 Filed 6-15-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 200 (Wednesday, October 16, 2019)]
[Notices]
[Page 55326]
[FR Doc No: 2019-22472]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2019-0001]

Notice of Adjustment of Disaster Grant Amounts

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: FEMA gives notice of an adjustment to the threshold for Small
Project subgrants made to state, tribal, and local governments and
private nonprofit facilities for disasters declared on or after October
1, 2019.

DATES: This adjustment applies to major disasters and emergencies
declared on or after October 1, 2019.

FOR FURTHER INFORMATION CONTACT: Tod Wells, Recovery Directorate,
Federal Emergency Management Agency, 500 C Street SW, Washington, DC
20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121-5207, as amended by the Sandy
Recovery Improvement Act, Public Law 113-2, provides that FEMA will
annually adjust the threshold for assistance provided under section
422, Simplified Procedures, relating to the Public Assistance program,
to reflect changes in the Consumer Price Index for All Urban Consumers
published by the Department of Labor.
    FEMA gives notice that $131,100 is the threshold for any Small
Project subgrant made to state, tribal, and local governments or to the
owner or operator of an eligible private nonprofit facility under
section 422 of the Stafford Act for all major disasters or emergencies
declared on or after October 1, 2019.
    FEMA bases the adjustment on an increase in the Consumer Price
Index for All Urban Consumers of 1.7 percent for the 12-month period
that ended in August 2019. This is based on information released by the
Bureau of Labor Statistics at the U.S. Department of Labor on September
12, 2019.

Catalog of Federal Domestic Assistance No. 97.036, Disaster Grants--
Public Assistance (Presidentially Declared Disasters).

Pete Gaynor,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. 2019-22472 Filed 10-15-19; 8:45 am]
 BILLING CODE 9111-11-P