[Federal Register Volume 82, Number 146 (Tuesday, August 1, 2017)]
[Rules and Regulations]
[Pages 35634-35636]
[FR Doc No: 2017-15476]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0331; Directorate Identifier 2016-NM-213-AD;
Amendment 39-18971; AD 2017-15-11]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc., Airplanes

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

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Bombardier, Inc., Model DHC-8-102, -103, -106, -201, -202, -301, -311,
and -315 airplanes. This AD was prompted by reports of undamped main
landing gear (MLG) extension in-service. This AD requires replacement
of the MLG retraction actuator rod-ends on both MLG assemblies. We are
issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective September 5, 2017.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of September 5,
2017.

ADDRESSES: For service information identified in this final rule,
contact Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt
Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>Internet
http://www.bombardier.com. You may view this referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available on the
Internet at http://www.regulations.gov by searching for and locating
Docket No. FAA-2017-0331.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0331; 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 street address for the Docket Office (telephone
800-647-5527) is Docket 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: Fabio Buttitta, Aerospace Engineer,
Airframe and Mechanical Systems Branch, ANE-171, FAA, New York Aircraft
Certification Office (ACO), 1600 Stewart Avenue, Suite 410, Westbury,
NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain Bombardier, Inc.,
Model DHC-8-102, -103, -106, -201, -202, -301, -311, and -315
airplanes. The NPRM published in the Federal Register on May 2, 2017
(82 FR 20453) (``the NPRM''). The NPRM was prompted by reports of
undamped MLG extension in-service. The NPRM proposed to require
replacement of the MLG retraction actuator rod-ends on both MLG
assemblies. We are issuing this AD to prevent MLG undamped extensions,
which could result in MLG structural failure, resulting in an unsafe
asymmetric landing gear configuration.
    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian Airworthiness Directive CF-
2016-36, dated November 22, 2016 (referred to after this as the
Mandatory Continuing Airworthiness Information, or ``the MCAI''), to
correct an unsafe condition

for certain Bombardier, Inc., Model DHC-8-102, -103, -106, -201, -202,
-301, -311, and -315 airplanes. The MCAI states:

    Two cases of undamped main landing gear (MLG) extension were
reported in-service. Investigation determined that the MLG
retraction actuator rod-ends failed as a result of non-conforming
threads. This condition, if not corrected, could lead to additional
MLG undamped extensions, which may result in MLG structural failure,
resulting in an unsafe asymmetric landing gear configuration.
    This [Canadian] AD mandates the replacement of the MLG
retraction actuator rod-end subassemblies manufactured with non-
conforming threads with units that fully conform to the design
requirements.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0331.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comment received. Air Line Pilots
Association, International supported the NPRM.

Conclusion

    We reviewed the relevant data, considered the comment received, and
determined that air safety and the public interest require adopting
this AD as proposed except for minor editorial changes. We have
determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    Bombardier, Inc., issued Service Bulletin 8-32-179, Revision A,
dated March 9, 2017. This service information describes procedures for
replacing the MLG retraction actuator rod-ends on both MLG assemblies
with units that fully conform to the design requirements. This service
information is reasonably available because the interested parties have
access to it through their normal course of business or by the means
identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 91 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
               Action                         Labor cost            Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Replacement........................  3 work-hours x $85 per hour          $2,078          $2,333        $212,303
                                      = $255.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this 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 the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

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):

2017-15-11 Bombardier, Inc.: Amendment 39-18971; Docket No. FAA-
2017-0331; Directorate Identifier 2016-NM-213-AD.

(a) Effective Date

    This AD is effective September 5, 2017.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Bombardier, Inc., Model DHC-8-102, -103, -
106, -201, -202, -301, -311, and -315 airplanes, certificated in any
category, serial numbers 003 through 672 inclusive, equipped with
main landing gear (MLG) retraction actuator assembly part number
10500-101, -103, -501, -551, or -553.

(d) Subject

    Air Transport Association (ATA) of America Code 32, Landing
Gear.

(e) Reason

    This AD was prompted by reports of undamped MLG extension in-
service. We are issuing this AD to prevent MLG undamped extensions,
which could result in MLG structural failure, resulting in an unsafe
asymmetric landing gear configuration.

(f) Compliance

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

(g) Replacement of MLG Retraction Actuator Rod-Ends

    At the applicable time specified in paragraph (g)(1) or (g)(2)
of this AD: Replace the MLG retraction actuator rod-ends on both MLG
assemblies, in accordance with the Accomplishment Instructions of
Bombardier Service Bulletin 8-32-179, Revision A, dated March 9,
2017.

    (1) For MLG retraction actuator assemblies with 37,000 total
flight cycles or more as of the effective date of this AD: Within 18
months or 2,700 flight cycles, whichever occurs first after the
effective date of this AD.
    (2) For MLG retraction actuator assemblies with fewer than
37,000 total flight cycles as of the effective date of this AD:
Within 24 months or 3,600 flight cycles, whichever occurs first
after the effective date of this AD.

(h) Alternative Installation of Part Number (P/N) 10500-105, -503, or -
555

    Installation of MLG retraction actuator assembly P/N 10500-105,
-503, or -555 on both MLGs is acceptable for compliance with the
replacement required by paragraph (g) of this AD.

(i) Credit for Previous Actions

    This paragraph provides credit for actions required by paragraph
(g) of this AD, if those actions were performed before the effective
date of this AD using Bombardier Service Bulletin 8-32-179, dated
July 10, 2015.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office (ACO), ANE-170, 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 ATTN: Program
Manager, Continuing Operational Safety, FAA, New York ACO, 1600
Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-
7300; fax<PHONE_NUMBER>. 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.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, New York ACO,
ANE-170, FAA; or Transport Canada Civil Aviation (TCCA); or
Bombardier, Inc.'s TCCA Design Approval Organization (DAO). If
approved by the DAO, the approval must include the DAO-authorized
signature.

(k) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) Canadian Airworthiness Directive CF-2016-36, dated November
22, 2016, for related information. This MCAI may be found in the AD
docket on the Internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2017-0331.
    (2) For more information about this AD, contact Fabio Buttitta,
Aerospace Engineer, Airframe and Mechanical Systems Branch, ANE-171,
FAA, New York ACO, 1600 Stewart Avenue, Suite 410, Westbury, NY
11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
    (3) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (l)(3) and (l)(4) of this AD.

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Bombardier Service Bulletin 8-32-179, Revision A, dated
March 9, 2017.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt
Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>Internet
http://www.bombardier.com.
    (4) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (5) You may view this 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 14, 2017.
Dionne Palermo,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2017-15476 Filed 7-31-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 48 (Friday, March 11, 2011)]
[Rules and Regulations]
[Page 13289]
[FR Doc No: 2011-5666]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[USCG-2011-0099]

Drawbridge Operation Regulations; Long Island, New York Inland
Waterway From East Rockaway Inlet to Shinnecock Canal, Hempstead, NY

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Commander, First Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
Meadowbrook State Parkway Bridge across the Sloop Channel, mile 12.8,
at Hempstead, New York. The deviation is necessary to install new link
arms at the bridge. This deviation allows the bridge to remain in the
closed position.

DATES: This deviation is effective from 7 a.m. on March 14, 2011
through 3 p.m. on March 25, 2011.

DATES: Documents mentioned in this preamble as being available in the
docket are part of docket USCG-2011-0099 and are available online at
http://www.regulations.gov, inserting USCG-2011-0099 in the ``Keyword''
and then clicking ``Search''. They are also available for inspection or
copying at the Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or e-mail Ms. Judy Leung-Yee, Project Officer, First Coast Guard
District<EMAIL_ADDRESS>telephone<PHONE_NUMBER>. If you
have questions on viewing the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    The Meadowbrook State Parkway Bridge has a vertical clearance in
the closed position of 22 feet at mean high water and 25 feet at mean
low water. The existing drawbridge operation regulations are listed at
33 CFR 117.799(h).
    The waterway has seasonal recreational vessels and fishing vessels
of various sizes. We contacted the commercial fishermen and no
objections were received.
    The New York Department of Transportation, requested a temporary
deviation to facilitate installation of new link arms.
    Under this temporary deviation the Meadowbrook State Parkway Bridge
at mile 12.8, across Sloop Channel, may remain in the closed position
between 7 a.m. and 3 p.m., Monday through Friday, from March 14, 2011
through March 25, 2011. Vessels that can pass under the bridge during
the closed periods without a bridge opening may do so at all times.
    In accordance with 33 CFR 117.35(e), the bridge must return to its
regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: February 28, 2011.
Gary Kassof,
Bridge Program Manager, First Coast Guard District.
[FR Doc. 2011-5666 Filed 3-10-11; 8:45 am]
BILLING CODE 9110-04-P


UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, D.C.

Issued by the Department of Transportation on January 30, 2004

NOTICE OF ACTION TAKEN -- DOCKET OST-2002-11725

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Application of    BRENDAN AIRWAYS, LLC d/b/a USA 3000 AIRLINES  filed
12/3/03 for:

XX  Renewal of exemption for two years under 49 U.S.C. §40109 to
provide the following service:

Scheduled foreign air transportation of persons, property, and mail
between the terminal point Philadelphia, Pennsylvania, and the terminal
point Cancun, Mexico.

Applicant rep:   Pierre Murphy<PHONE_NUMBER>    DOT Analyst:  Linda L.
Lundell<PHONE_NUMBER>

D I S P O S I T I O N

XX  Granted, subject to conditions (See below).

The action above was effective when taken:   January 30, 2004,  through
 January 30, 2006 .

Action taken by:   Paul L. Gretch, Director

		        Office of International Aviation

XX  Authority granted is consistent with the aviation agreement between
the United States and Mexico.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:

XX  Holder’s certificates of public convenience and necessity

XX  Standard Exemption Conditions (attached)

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

Special Conditions:  The U.S.-Mexico exemption authority granted is
subject to the dormancy notice requirements set forth in condition 7 of
Appendix A of Order 88-10-2.

________________________________________________________________________
_____________________________

On the basis of data officially noticeable under Rule 24(g) of the
Department’s regulations, we found the applicant qualified to provide
the services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the application was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
 To the extent not granted, we denied all requests in the referenced
Docket.  We may amend, modify, or revoke the authority granted in this
Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov/reports_aviation.asp

						APPENDIX

U.S. Carrier Standard Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with all applicable requirements of the Federal Aviation
Administration and with all applicable U.S. Government requirements
concerning security.  To assure compliance with all applicable U.S.
Government requirements concerning security, the holder shall, before
commencing any new service (including charter flights) to or from a
foreign airport, contact its Principal Security Inspector (PSI) to
advise the PSI of its plans and to find out whether the Transportation
Security Administration has determined that security is adequate to
allow such airport(s) to be served; and

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

											8/2003

   The carrier filed an Erratum on January 29, 2004, to reflect the
correct docket number in this matter.


[Federal Register Volume 78, Number 118 (Wednesday, June 19, 2013)]
[Notices]
[Pages 36786-36787]
[FR Doc No: 2013-14579]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0012]

Linking Marketplace Heparin Product Attributes and Manufacturing
Processes to Bioactivity and Immunogenicity

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of grant funds for the support of a sole source award to
the University of North Carolina. The goal of the award is to identify
what component(s) of the complex heparin mixtures have the propensity
to cause heparin induced thrombocytopenia (HIT) to improve the safety
of heparin drug products. The FDA seeks to identify the components of
the heparin mixture that are associated with HIT so that actions may be
taken to reduce these events and improve patient outcomes with this
widely used drug.

DATES: Important dates are as follows:
    1. The application due date is July 15, 2013.
    2. The anticipated start date is August, 2013.
    3. The opening date is the date this announcement is published in
the Federal Register.
    4. The expiration date is July 16, 2013.

ADDRESSES: Submit the paper application to: Gladys Melendez at the Food
and Drug Administration, Grants Management (HFA-500), 5630 Fishers
Lane, Rockville, MD 20857. For more information, see section III of the
SUPPLEMENTARY INFORMATION section of this notice.

FOR FURTHER INFORMATION CONTACT: David Keire, Center for Drug
Evaluation and Research, Food and Drug Administration, 1114 Market St.,
rm. 1002, St Louis, MO, 63130,<PHONE_NUMBER>; or Gladys Melendez, Office
of Acquisition Support and Grant Services, Food and Drug
Administration, 5630 Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>,
email<EMAIL_ADDRESS>    For more information on this funding opportunity announcement (FOA)
and to obtain detailed requirements, please contact<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

    Request for Application: FDA RFA-13-007
    [Catalog of Federal Domestic Assistance: 93.103]

A. Background

    The goal of this Research Project is to identify which components
of heparin drug mixtures have the propensity to cause heparin induced
thrombocytopenia (HIT) in order to improve the safety profile of this
widely used anticoagulant. Heparin is a heterogeneous mixture of
polysaccharides of varying length, sulfation pattern, acylation and
conformation that has been in clinical use since the 1930s. HIT is a
drug-dependent immune disorder caused by antibodies to complexes formed
between platelet factor 4 (PF4) and heparin which can occur in patients
who undergo major trauma (e.g. broken bones and cardiovascular surgery)
and receive heparin. The condition leads to formation of abnormal blood
clots and concomitant complications associated with clots. PF4-heparin
antibodies are observed in all patients with HIT. In addition, low
molecular weight heparins or the synthetic pentasaccharide
(fondaparinux) have also been shown to cause HIT antibody formation
although these smaller chain length heparins are much less likely to
lead to clinical HIT symptoms.
    The major limitation in the available reagents for studies aimed at
identifying the components of heparin that lead to the pathogenesis of
HIT is the lack of pure component heparin standards. Therefore, this
collaboration brings together the following capabilities and
laboratories: (1) Synthesis of heparin chains of the same length,
sulfation pattern and conformation (Dr. Liu at the University of North
Carolina and Dr. Linhardt at Rensselaer Polytechnical Institute), (2)
synthesis and physicochemical characterization of heparin and heparin-
PF4 complexes (Keire FDA/DPA St Louis) and (3) a HIT-immunogenicity
animal model (Dr. Arepally at Duke University). FDA believes that this
combination of skills and expertise has the potential to make pure
standards, fully characterize the standards, create and characterize
PF4-heparin standard aggregates and assess their propensity to elicit
an immune response in an animal model. This research is unique and not
otherwise available. The ability to make pure heparin standards in gram
quantities and fully characterize their properties is only available
from the Liu and Linhardt laboratories. Furthermore, Dr. Arepally's
mouse model of HIT immunogenicity is not available in any other
laboratory. When completed the study will identify heparin components
that enhance HIT propensity and which could potentially be minimized in
heparin manufacturing, leading to safer heparin drugs with better
patient outcomes.

B. Research Objectives

    The research objective is to identify the components of the heparin
mixture that have the propensity to lead to HIT pathogenesis.

C. Eligibility Information

    This is a sole source RFA because the investigators identified in
this document have unique skills and expertise necessary to perform the
proposed work.

II. Award Information/Funds Available

A. Award Amount

    Only one award will be available to the University of North
Carolina in the amount of $250,000 (Total Cost) in the first year.

B. Length of Support

    Depending on research progress and subject to the availability of
funds additional funds may be awarded under this grant for up to a five
year project period reflecting $250,000 Total Cost per year.

III. Paper Application, Registration, and Submission Information

    To submit a paper application in response to this FOA, applicants
should first review the full announcement. Persons interested in
applying for a grant may obtain an application at http://grants.nih.gov/grants/forms.htm.
    For all paper application submissions, the following steps are
required:
     Step 1: Obtain a Dun and Bradstreet (DUNS) Number
     Step 2: Register With Central Contractor Registration

     Step 3: Register With Electronic Research Administration
(eRA) Commons
    Steps 1 and 2, in detail, can be found at http://www07.grants.gov/applicants/organization_registration.jsp. Step 3, in detail, can be
found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed these steps,
submit paper applications to: Gladys Melendez; Grants Management, Food
and Drug Administration, 5630 Fishers Lane, rm. 2032; HFA-500;
Rockville, MD 20857.

    Dated: June 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-14579 Filed 6-18-13; 8:45 am]
BILLING CODE 4160-01-P


                    Supporting Statement for a Request for
                 OMB Review under the Paperwork Reduction Act

1	IDENTIFICATION OF THE INFORMATION COLLECTION

	1(a)	Title and Number of the Information Collection

            Title:	Health and Safety Data Reporting, Submission of Lists and Copies of Health and Safety Studies

            EPA ICR No.:   0575.16	OMB Control No.:   2070-0004

            Docket ID No.: EPA-HQ-OPPT-2017-0646

	1(b)	Short Characterization

      On September 2, 1982, EPA promulgated the final Section 8(d) Model Health and Safety Data Reporting Rule (40 CFR Part 716) pursuant to the Toxic Substances Control Act (TSCA) (15 U.S.C. 2607(d). This rule was revised by amendments on September 15, 1986 (51 FR 32720) and April 1, 1998 (63 FR 15765). The rule describes the requirements and procedures for submitting lists and copies of unpublished health and safety studies under section 8(d) of TSCA (40 CFR Part 716). The rule requires manufacturers (including importers) and (if specified) processors to submit lists and copies of health and safety studies relating to the health and/or environmental effects of the chemical substances and mixtures listed in the TSCA section 8(d) rule. The listed chemical substances and mixtures include chemicals recommended for testing under TSCA section 4 by the Interagency Testing Committee (ITC) and other chemical substances that EPA (particularly the Office of Pollution Prevention and Toxics (OPPT)), or other federal agencies, choose to assess for health or environmental effects. EPA amends the TSCA section 8(d) rule periodically to add chemical substances and mixtures. The Frank R. Lautenberg Chemical Safety for the 21[st] Century Act amending TSCA was enacted on June 22, 2016; however, Section 8(d) was not modified.

	To comply with the reporting requirements of the rule, the respondents (manufacturers and processors) must search their files to identify any health and safety studies in their possession, copy and process the relevant studies, make lists of studies that are currently in progress, and review the studies for confidential business information.

	All studies submitted to EPA will be verified and the contents of the submissions recorded and inspected for the inclusion of confidential business information. Copies of the documents will then be prepared and distributed, based on the associated chemical identity, to program offices at EPA and/or to other federal agencies for scientific analysis. A coding form will be completed to capture certain descriptive information such as identity, document control number, confidentiality indicator, document title, document date, receipt date and chemical identity. The document will be stored electronically for archival purposes. In addition, EPA will make non-confidential versions of the health and safety studies available via its ChemView database (www.epa.gov/chemview). EPA will use the studies to support its investigation of the risks posed by listed chemicals and, in particular, to support its decisions on whether to require industry to test chemicals under section 4 of TSCA.

      The total economic burden imposed by TSCA section 8(d) on the regulated community is estimated at 302 hours with an associated cost of $24,435 (21 respondents). The total estimated respondent burden is based on a rate of 13 chemical additions per year. The Agency has not used its authority under section 8(d) since 2008. As such, the estimate of 13 chemical additions per year appears high considering that no chemicals were added between 2009 and 2017. However, given the new requirement to prioritize chemicals under the Lautenberg Chemical Safety for the 21[st] Century Act, it is possible that the Agency may start requesting section 8(d) reporting more frequently.

2	NEED FOR AND USE OF THE COLLECTION

	2(a)	Need/Authority for the Collection

	TSCA section 8(d), 15 U.S.C. 2607(d), requires EPA to promulgate rules requiring persons who manufacture, process or distribute in commerce, or propose to manufacture, process or distribute in commerce chemical substances and mixtures, to submit to EPA lists and copies of health and safety studies in their possession with respect to such chemical substances and mixtures. EPA regulations implementing the statute are codified at 40 CFR Part 716. EPA/OPPT receives and reviews these studies to determine whether information gaps on hazard, health or environmental effects, or exposure of the listed chemicals exist and, if so, the kinds of testing needed to fill such information gaps; to assess risks; and for considering control actions. Collection of unpublished health and safety studies can reduce the need for testing. TSCA as amended by the Lautenberg Chemical Safety for the 21[st] Century Act requires EPA to develop a pipeline of chemicals for prioritization and risk evaluation. Information from section 8(d) health and safety studies could help to inform the Agency's prioritization and risk evaluation work. Additionally, other federal agencies use the studies when they are assessing a listed chemical substance for health or environmental effects.

	2(b)	Use/Users of the Data

	Studies submitted pursuant to TSCA section 8(d) rules will be evaluated in conjunction with other available data as EPA assesses risks of existing chemicals. EPA and other federal agencies will use the data to construct a complete picture of the known effects of the chemical substance. From this picture, OPPT will be able to determine what kinds of information gaps, if any, exist and whether testing may be needed. The TSCA section 8(d) studies will ensure that OPPT bases its testing decisions on the most complete information available and does not require unnecessary or duplicative testing, which is consistent with the requirements of TSCA section 4(h).

	In addition, EPA will require that copies of unpublished health and safety studies be submitted on chemicals that are being considered for prioritization under section 6 of TSCA or in the early stages of risk assessment or when action to control exposure is being considered by EPA or another federal agency. These chemicals may be ones for which persons have submitted a substantial risk notification under TSCA section 8(e), or other chemicals for which data are needed to support a control measure under sections 5 and 6 of TSCA or under other EPA-administered statutes. If this information collection did not exist, EPA would not be able to obtain the available information on a chemical and evaluate the need for testing or data development under section 4 of TSCA or controlling chemical substances under TSCA sections 5 and 6.

	 In the past, EPA's Office of Air and Radiation (OAR) has used the submitted studies for developing Tier II analyses and the EPA's Office of Research and Development (ORD) has used the information for developing extended risk assessments. In addition, other organizations have utilized the submitted studies: the Consumer Product Safety Commission (CPSC) for assessing the hazards of known consumer exposure; the American Council for Government Industrial Hygienists (ACGIH); and the National Institute for Occupational Safety and Health (NIOSH) for developing recommended occupational exposure levels.

3	NON-DUPLICATION, CONSULTATIONS AND OTHER COLLECTION
      CRITERIA

	3(a)	Non-Duplication

	In drafting a TSCA section 8(d) rule, EPA considers all available information, i.e., published and unpublished literature, databases, and all data available from EPA programs and offices and other federal entities. If existing data are sufficient for assessment or control purposes, EPA will not require TSCA section 8(d) reporting. However, if that information is not sufficient, or is obtained in a way that makes EPA doubt its validity, then the Agency must require the submission of non-published health and safety studies.

	The unpublished health and safety studies to be submitted under the TSCA section 8(d) rule are not available from any other source. The TSCA section 8(d) rule requires the listing and submission of studies that are conducted in-house by industry or by industry contractors and not published in the scientific literature. Under the revisions to the rule promulgated in September 1986, respondents do not have to list or submit any studies that have been published in the scientific literature, or submitted previously to OPPT on a non-confidential basis. Studies that respondents previously have submitted on a non-confidential basis to other EPA offices or programs need only be listed.

      3(b)	Public Notice Required Prior to ICR Submission to OMB

      Prior to submission to OMB, this ICR will be made available to the public for comment through a Federal Register notice. The public will have 60 days to provide comments. Any comments received will be given consideration when completing the supporting statement that is submitted to OMB.

	3(c)	Consultations

      Under 5 CFR 1320.8(d)(1) OMB requires agencies to consult with potential ICR respondents and data users about specific aspects of ICRs before submitting an original or renewal ICR to OMB for review and approval. In accordance with this regulation, EPA will pursue additional consultations with interested parties during the development of the renewal of this collection.

	3(d)	Effects of Less Frequent Collection

	In most instances, respondents will be required to make only initial submissions under the TSCA section 8(d) rule. However, after the initial submission of lists and studies, respondents are required to notify EPA when certain health and safety studies are initiated by submitting a list of newly initiated studies. Because the reporting frequency for the TSCA section 8(d) rule is generally only once, the reporting frequency cannot be reduced. If the information requirement were less frequent, EPA would not be able to obtain the necessary information for evaluating the need for additional information under section 4 of TSCA or evaluating and controlling chemical substances under sections 5 and 6 of TSCA.
	3(e)	General Guidelines

	This information collection activity is necessary to implement the statutory requirements of section 8(d) of TSCA and is consistent with the requirements of the PRA, OMB implementing regulations (5 CFR 1320.6), and OMB Guidance.

	3(f)	Confidentiality

	Submitters may designate information as confidential, trade secret, or proprietary. EPA has implemented procedures to protect any confidential, trade secret or proprietary information from disclosure. These procedures comply with TSCA section 14 and EPA's confidentiality regulation, 40 CFR Part 2, Subpart B.

	3(g)	Sensitive Questions

	This section is not applicable. The information requested is not sensitive in nature.

4	THE INFORMATION COLLECTED - AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT

	4(a)	Agency Activities

	The activities routinely conducted by EPA related to the rule development, processing, analysis and storage of the information collected under this rule include the following:

       Review and select chemicals;
       Develop and issue an amendment to the TSCA section 8(d) rule to add the substances or mixtures;
       Answer respondents' questions;
       Process and analyze rule submissions;
       Maintain and distribute the data; and
       Analyze submissions for confidentiality and analyze the information provided to substantiate the confidentiality claim.

	4(b)	Collection Methodology and Management

	EPA's current collection methodology and information management system is based on the current requirements in 40 CFR 716.30 and 716.35 for the submission of electronic copies, which was implemented by a rule published in the Federal Register on December 4, 2013 (78 FR 72818).

	To aid persons subject to this information collection, OPPT has set up a TSCA Hotline that provides information regarding TSCA section 8(d) reporting as well as other regulatory information. When Hotline staff are unable to answer questions regarding TSCA section 8(d), the questions are referred to OPPT staff for appropriate resolution.

	All Non-Confidential Business Information submitted under TSCA section 8(d) is placed in the OPPT public docket, indexed and available for public inspection. TSCA section 8(d) submissions are also being made available through the ChemView database (see https://java.epa.gov/chemview), a publicly available and searchable database.

	4(c)	Small Entity Flexibility

	The TSCA section 8(d) rule applies to all manufacturers and processors of chemicals and others in possession of studies, regardless of size. However, EPA does not anticipate that many small businesses possess health and safety studies because they are unlikely to have the financial resources to perform the studies on chemicals subject to the rule. Therefore, the burden on such companies should be minimal.

	4(d)	Collection Schedule

	The collection scheduled under this ICR is chemical-specific in nature and occurs once in an established time frame between 60 days and 2 years. Reporting of information is only required when the subject matter information (i.e., the lists of studies and final study reports) is available. Availability of study reports on the list may occur after the established reporting period for the list, and must still be submitted when they become available. Studies previously submitted to OPPT are exempt.

	Amendments adding substances can be made to the Health and Safety Data Reporting Rule subsequent to the ITC's semiannual addition of substances and categories of substances to the TSCA section 4(e) Priority List. Other substances can be added when there is a demonstrated need for the information.

5	THE RESPONDENTS AND THE INFORMATION REQUESTED

	5(a)	Respondents/NAICS Codes

	Respondents affected by this collection activity are identified mainly by North American Industry Classification System (NAICS) codes 325 (chemical manufacturing and allied products) and 32411 (petroleum refiners).

      5(b)	Information Requested

	(i)	Data Items

	Persons who manufacture (which includes import) chemical substances and mixtures, or propose to do so, and processors of such substances and mixtures (if specifically identified in a particular rule) must submit copies of the unpublished health and safety studies in their possession for the listed substances or mixtures. They must also submit lists of reportable studies that they initiate or, about which they know, for each of the listed substances or listed mixtures.

	All submitted studies must be accompanied by a cover letter that contains the following data (40 CFR 716.30):

 Name,
 Job title,
 Address, and
 Telephone numbers of the submitting official.
 Name and address of the manufacturing or processing establishment on whose behalf the submission was made.
 Identify any impurity or additive known to have been present in the substance or listed mixtures as studied, unless so noted in the study.
 Identify that the study is being submitted under Part 716.
	Respondents may voluntarily choose to develop and submit robust summaries of the full toxicological study reports in conjunction with the submitted full study reports. The robust summaries should contain technical information to adequately describe the study and results, and should be written such that the information provided is sufficient to allow a technically qualified person to evaluate study results. Typically, a robust summary would include a description of the test substance, methods, results, conclusions, data quality description, and references associated with the full study.

	List of studies shall include (40 CFR 716.35): (1) ongoing health and safety studies conducted by or initiated by respondents; (2) studies respondents know about but do not have copies of; and, (3) studies that have been sent to another federal agency with no claims of confidentiality.

      For ongoing health and safety studies conducted by or initiated for the respondent, the list should include the following data:

 Beginning date of the study
 Purpose of the study
 Types of data to be collected
 Anticipated date of completion
 Name and address of the laboratory conducting the study
      For studies known to the respondent but for which they do not possess copies, the list should include the following data:

 Name and address of a person known to them that possess a copy of the study.
      For studies previously sent to a federal agency with no claims of confidentiality, the list should include the following data:

 Title of the study
 Name and address of the person to whom the study was sent
 Month and year in which the study was submitted
	(ii)	Respondent Activities

      A representative respondent would engage in the following activities in order to produce the lists of studies and required data listed in section 5(b)(i) of this supporting statement:

 Determine whether the firm may be required to report. If so, review the rule in more detail;
 Conduct a corporate review to identify which firm sites must be searched to locate the appropriate health and safety studies;
 Search the files at appropriate sites to locate relevant studies;
 Compile and transcribe lists of studies being submitted, ongoing studies, newly initiated studies, studies known to exist but not known to be in the respondent's possession, and studies previously submitted to other federal agencies without confidentiality claims;
 Photocopy or prepare electronic versions of the studies;
 Voluntarily prepare robust summaries of the studies;
 Review the responses for possible confidential business information and prepare information to substantiate a claim of confidentiality; and
 Submit the studies to EPA electronically, and, after initial study submissions, notify EPA when other studies are initiated; submit studies completed after the reporting period.

6	ESTIMATING THE COST AND BURDEN OF THE COLLECTION

      The methodology used for estimating the burden and costs to industry resulting from the addition of chemicals to the TSCA section 8(d) rule over the next three years is derived from the previous information collection request (ICR). EPA has added chemicals to the TSCA section 8(d) list on an episodic basis. As shown in Table 1, chemicals have been added to the list four times since 1996 yielding a historical average of 13 chemicals per year for the years between 1996 and the present. As such, EPA uses a basis of 13 chemical additions per year for the 2018-2021 ICR period.

Table 1. Number of Chemicals Added to the TSCA Section 8(d) Reporting List.
                                     Year
                                     1996
                                   1997-2003
                                     2004
                                     2005
                                     2006*
                                     2007
                                    2008**
                                   2009-2017
                                 Average/Year

                             Number of Chemicals
                                      47
                                       0
                                      15
                                       0
                                      208
                                       0
                                      12
                                       0
                                      13

* EPA issued a TSCA section 8(d) rule (71 FR 47130) on August 16, 2006 for 243 HPV chemicals that were not sponsored in the voluntary portion of the HPV Challenge Program. EPA later withdrew 33 of these chemicals in a final rule issued on September 29, 2006 (71 FR 57439). In a subsequent direct final rule issued on April 30, 2007, EPA removed two additional chemicals (72 FR 21119), resulting in a total of 208 chemicals subject to Section 8(d) reporting.  (**) The TSCA Interagency Testing Committee added Lead and Lead Compounds to the Priority List as part of its 60[th] ITC Report. Based on this addition, EPA issued a final rule on January 20, 2008 (73 FR 5190) which added 12 Lead and Lead compounds to 40 CFR 716.120.

      Moreover, to characterize the reporting implications per chemical addition associated with Section 8(d) reporting, this analysis uses TSCA Inventory Update Rule data from the 1998, 2002, and 2006 reporting cycles, and Chemical Data Reporting Rule data from the 2012 reporting cycle. Table 2 summarizes the models and bases, as applied to the 2018-2021 ICR renewal.

Table 2:  Reporting Implications per Chemical Added

                                   Generic
                                    Model
                    ICR 2015-18               Model Sources
ICR                                                2015-2018                                        Detailed Model
                    ICR 2018-21               Model Sources
ICR                                                2018-2021                                        Detailed Model
                              BASIS ICR 2018-2021
Number of firms potentially impacted per chemical
TSCA IUR data, all manufacturers 1998, 2002, 2006: 344 firms associated with 208 chemicals

TSCA IUR/CDR data, all manufacturers 1998, 2002, 2006, 2012: 348 firms associated with 220 chemicals

                                      1.6
Sites per firm
TSCA IUR data, all manufacturers 1998, 2002, 2006: 344 firms associated with 208 chemicals; Sites per firm

TSCA IUR/CDR data, all manufacturers 1998, 2002, 2006, 2012: 348 firms associated with 220 chemicals; Sites per firm

                                      1.5
Fraction of firms potentially affected who submit reports of studies
TSCA IUR data, all manufacturers 1998, 2002, 2006: 59 firms submitted 527 studies associated with 208 chemicals

TSCA IUR/CDR data, all manufacturers 1998, 2002, 2006, 2012: 63 firms submitted 541 studies associated with 220 chemicals

                                     0.18
Number of studies per firm
TSCA IUR data, all manufacturers 1998, 2002, 2006: 59 firms submitted 527 studies associated with 208 chemicals

TSCA IUR/CDR data, all manufacturers 1998, 2002, 2006, 2012: 63 firms submitted 541 studies associated with 220 chemicals

                                       9
Average length of study, pages
TSCA IUR data, all manufacturers 1998, 2002, 2006: 59 firms submitted 527 studies associated with 208 chemicals
                                      20
TSCA IUR/CDR data, all manufacturers 1998, 2002, 2006, 2012: 63 firms submitted 541 studies associated with 220 chemicals
                                     same
                                      20
Percent studies with robust summaries;      number of firms affected
10% of total studies
10% of reports
10% of total studies
                               10% of reports
                           1 Robust Summary per Firm
Percent of affected firms submitting second responses
5% of affected firms
                                      5%
                                 5% affected
                                  5% affected
                                      5%

      6(a)	Estimating Respondent Burden

      Firms will undertake a number of actions in response to a TSCA section 8(d) listing and the unit burden associated with each of these tasks is discussed in detail below.

      Review the Rule. Firms in the relevant industries that may have unpublished health and safety studies will have to determine whether they manufacture (including import) a listed chemical and may thus be required to report. If so, they will have to review the rule in detail to understand its requirements, such as the types of health and safety studies EPA is asking for, the grade or purity of the test material, and the timeframe of the reporting period.

      Note that, unless EPA specifies otherwise, the coverage of section 8(d) rules is limited to chemical manufacturers and petroleum refineries. Most firms in these industries will not manufacture a listed chemical, and many will spend a de minimis amount of time making that determination. Those firms that manufacture a listed chemical must review the rule to understand its specific requirements. This is estimated to take an average of 2 hours of managerial time for each firm manufacturing a listed chemical.

      Conduct Corporate Review for Site Identification. Firms that manufacture a listed chemical will need to conduct a corporate review to identify which of the firm's sites must be searched for appropriate health and safety studies. This corporate review is estimated to require an average of 3 managerial hours per firm.

      Conduct Site File Search. Firms that manufacture a listed chemical must search the files at appropriate sites to look for studies that are responsive to the TSCA section 8(d) rule. It is estimated that the search will take an average of 3 hours of technical time per site. EPA estimates that each firm will have an average of 1.5 sites manufacturing a listed chemical. This yields an average burden of 4.5 technical hours per firm for site file searching (3 hours per site * 1.5 sites per firm).

      Provide Study Title Lists. Respondents are required to submit lists containing the titles of any studies being submitted, titles of studies that are initiated or ongoing during the reporting period but that have not yet been completed, titles of any unpublished studies that the respondent knows to exist but does not have in its possession, and titles of studies previously submitted to other federal agencies without confidentiality claims. EPA expects that the major burden of compiling this list was incurred during the file search and would already be available in electronic format; therefore, there is no additional burden associated with this activity.

      Prepare Robust Summaries. Respondents may choose to develop and submit robust summaries of the full toxicological study reports. The robust summaries should contain technical information to adequately describe the study and results, and should be written in such a way that the information provided is sufficient to allow a technically qualified person to evaluate study results. Typically, a robust summary would include a description of the test substance, methods, results, conclusions, data quality description, and references associated with the full study. It is estimated that 8 to 16 hours of technical time are needed to develop and review a robust summary, depending on the type of study conducted. This ICR assumes an average of 12 hours of technical time to prepare a robust summary. Because submission of robust summaries is voluntary, EPA does not expect that many companies will undertake this activity. EPA estimates that each firm will submit an average of 9 studies, with 10% of those studies including a robust summary; therefore, EPA expects to receive an average of 0.9 robust summaries per firm submitting studies, which we round up to 1 robust summary per firm submitting studies. The estimated average burden per robust summary is 12 hours of technical time.

      Review Responses for Confidential Business Information (CBI). Firms will need to review responses for possible CBI and delete any material that is considered by the firm to be CBI from one copy of the study. A separate copy of the study must be submitted without deletions of CBI. CBI review is estimated to take an average of 1 hour of managerial time for each study. Since each of the 21 firms is submitting an average of 9 studies, CBI review results in an estimated average of 9 hours of managerial time per firm.

      CBI Legal Review and Confidential Business Substantiation. Firms will need to gather and prepare information to substantiate a claim for confidentiality. This will also involve approximately 1.5 hours of managerial and attorney time.

      Post-Reporting Period:  Submit Ongoing or Newly-Initiated Studies. Firms that have an ongoing or newly-initiated study during the reporting period are required to provide EPA with a copy of the study once it is completed. CBI review and submission of ongoing or newly-initiated studies are estimated to require an average of 1 hour of managerial time.

Table 3. Unit Burden for TSCA Section 8(d) Reporting

                              Collection Activity
                        Affected Respondents (Weight)*
                        Average Burden per Firm (Hours)
                                Labor Category
1. Review of Rule
                                     1.000
                                       2
                                  Managerial
2. Site Identification
                                     1.000
                                       3
                                  Managerial
3. Site File Search**
                                     1.000
                                      4.5
                                   Technical
4. Robust Summaries
                                     0.008
                                      12
                                   Technical
5. CBI Review
                                     0.168
                                       9
                                  Managerial
6. CBI Legal Review and CBI Substantiation
                                     0.168
                                     0.75
                                  Managerial

                                     0.168
                                     0.75
                                   Attorney
7. Post-Reporting Period Submission
                                     0.008
                                       1
                                  Managerial
*Not all respondents perform all activities. This weight reflects that for every firm that has to check for reports:  18% will submit reports, of which 1 firm (about 5%) will provide robust summaries and 5% (about 1 firm) will provide a second response.
** Basis of 1.5 sites per firm

      These unit burden estimates are average values. Large multi-divisional, multi-departmental firms may require more than the average time to comply. However, there are smaller firms that are less complicated, and these firms may have a simpler process that requires less time.

      6(b)	Estimating the Respondent Universe

      The number of chemicals added to the section 8(d) list has varied significantly from year to year and has been zero for many years. EPA has added a total of 282 chemicals to the list since 1996 (47 in 1996, 15 in 2004, 208 in 2006, and 12 in 2008), which is an overall program historical average of approximately 13 chemicals per year. For estimates in this ICR, EPA assumes that the historical average of 13 chemicals per year will be added to the section 8(d) list from 2018 to 2021, for a total of 39 chemicals over the three-year ICR period. Assuming that each chemical that is added to the list impacts 1.6 firms, then EPA expects 21 chemical manufacturing firms to be affected per year by this ICR.

      Based on the reporting bases stated on Table 2, EPA assumes that 18% percent of the potentially affected manufacturers will submit studies each year, yielding 4 firms submitting studies (0.18 * 21 manufacturers). Each submitting firm is expected to submit a total of 9 studies, yielding an estimated total of 36 studies annually (4 firms * 9 studies per firm). A total of 10% of the studies are expected to contain robust summaries, yielding a total of 1 robust summary per firm (9 studies * 0.10, and rounding up to 1); and approximately 1 firm (5% of 4 firms) is estimated to submit a second response (for a newly initiated or ongoing study) after the reporting period ends.

      The number of firms estimated to engage in the various reporting activities is summarized in Table 4. Note that not all respondents incur every aspect of reporting burden. For this analysis, the conditions of the 2006 and 2008 section 8(d) rules and their reporting implications, along with the condition of 13 chemical additions per year, are assumed.

Table 4: Number of Firms Affected per Year, by Activity          (13 Chemicals Added Per Year)
                              Collection Activity
                                 No. of Firms
Review of Rule
                                      21
Site Identification
                                      21
Site File Search
                                      21
Robust Summaries
                                       4
CBI Review
                                       1
Post-Reporting Period Submission
                                       1

      The number of firms or studies described above is combined with the estimated average unit burden hours and wages from Tables 3 and 5 to estimate the total burden hours and cost per year based on three types of response activities:  searching files, submitting studies during the reporting period, and submitting studies after the reporting period. The results are shown in Table 6.

      6(c)	Estimating Respondent Cost

Unit labor costs are calculated by adding fringe benefits and overhead to the wage or salary to derive a fully loaded labor cost. Costs are calculated for managerial, professional/technical, and clerical workers. Wages and fringe benefits for managerial, professional/technical, and clerical labor are taken from the Bureau of Labor Statistics (BLS) Employer Costs for Employee Compensation (ECEC) manufacturing industry data from 2016. The cost of fringe benefits such as paid leave and insurance are taken from the same ECEC series for each labor category. Fringe benefits as a percent of wages are calculated separately for each labor category. Table 5 presents these results with fully loaded rates for attorney labor at $116.15, managerial labor at $83.15/hour; for technical labor at $78.08/hour; and for clerical labor at $34.29/hour.

Table 5: Loaded Hourly Wage Rates by Labor Category in 2016$
                                Labor Category

                                     Wage
                                Fringe Benefits
                             Fringes as % of Wage
                             Overhead % of Wage[3]
                           Fringe + Overhead Factor
                                 Loaded Wages

                                      (a)
                                      (b)
                                 (c) = (b)/(a)
                                      (d)
                                (e)=(1)+(c)+(d)
                                (f) = (a) x (e)
Attorney[1]
                                    $69.97
                                    $34.40
                                    49.17%
                                      17%
                                     1.66
                                    $116.15
Managerial[2]
                                    $50.09
                                    $24.63
                                    49.17%
                                      17%
                                     1.66
                                    $83.15
Technical[2]
                                    $45.66
                                    $24.98
                                    54.70%
                                      17%
                                     1.71
                                    $78.08
Clerical[2]
                                    $20.29
                                    $10.52
                                    51.848%
                                      17%
                                     1.69
                                    $34.29
Sources: [1] BLS Occupational Employment Statistics (OES) May 2016 National Industry-Specific Occupational Employment and Wage Estimates (BLS, 2016b) [2]Employer Costs for Employee Compensation Supplementary Tables: December 2006-December 2016, US Bureau of Labor Statistics (BLS, 2016a)
[3]An overhead rate of 17 percent was estimated based on industry data gathered for the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002a) and Wage Rates for Economic Analyses of the Toxics Release Inventory Program. (EPA, 2002b)

      6(d)	Estimating Reporting Burden and Costs

Table 6. Annual Respondent Cost and Burden Hour Estimates
                            Information Collections
                              Response Activities
                          Burden per Response (Hours)
                                Labor Category
                               Cost per Response
                              Number of Responses
                             Total Burden (Hours)
                                  Total Cost
Compliance determination and data search
Rule review
                                       2
                              Managerial ($83.5)
                                     $769
                                      21
                                      200
                                    $16,149

Site Identification
                                       3
                              Managerial ($83.5)

Site File Search
                                      4.5
                              Technical ($78.08)

Submission of health and safety studies during the reporting period and CBI Substantiation
Robust summaries
                                      12
                              Technical ($78.08)
                                    $1,838
                                       4
                                      90
                                    $7,352

CBI Review
                                       9
                              Management ($83.5)

CBI Legal Review and CBI Substantiation
                                     0.75
                              Managerial ($83.5)

                                     0.75
                              Attorney ($116.15)

Notification and submission of health and safety studies initiated and/or completed after the reporting period
Post-reporting period submission
                                      1.0
                                  Managerial
                                     $83.5
                                       1
                                       1
                                     $83.5
Total
                                      26
                                      291
                                    $23,584

      A typical firm submitting a response is conservatively estimated to engage in review of the rule, site identification, site file search, preparing study title lists, CBI review, CBI substantiation, and possibly submit a robust summary and/or a post-reporting period submission. Assuming that 13 chemicals per year are added to the TSCA section 8(d) list and that reporting is similar to the 2006 and 2008 section 8(d) reporting experiences, but considering that the CBI substantiation has been added, the average annual burden and cost per response is 11 hours and $907, respectively.

      6(e) 	CDX Registration Activities to Enable Electronic Reporting

      EPA estimates that respondents will incur a small amount of cost in carrying out the additional paperwork activities that were imposed by the Electronic Reporting under the Substances Control Act (TSCA) Final Rule. This includes the burden associated with activities that facilitate submission of an electronic report: CDX registration and CDX electronic signature. These activities occur only once for each submitter. Some submitters may already have registered to use the e-TSCA web reporting tool in CDX (and obtained an accompanying electronic signature) in order to comply with the mandatory electronic reporting requirements of EPA's e-PMN rule and/or IUR/CDR rule. Those submitters will not need to repeat the CDX registration and e-signature process in order to file their health and safety studies. While there may be some overlap in the specific individuals that have already completed CDX activities, EPA is using a conservative assumption that all submitters who will file electronically will need to register with CDX and, thus, incur associated burdens. This assumption may overestimate the burdens and costs actually experienced by respondents.

      The one-time CDX burden includes the following:

CDX Registration  -  Based on the CROMERR Cost Benefit Analysis, EPA assumed that companies would spend 11 minutes per employee to register with CDX (EPA, 2004). Furthermore, EPA assumed that an average of four technical staff members and one manager would need to register for each company, resulting in 55 minutes of burden per firm.

CDX electronic signature (labor burden)  -  Based on the CROMERR Cost Benefit Analysis, EPA assumed that firms would spend 15 minutes preparing, submitting, and filing an electronic signature agreement (Authentication of Identity) form to EPA per employee (EPA, 2004). One manager and four technical staff members per firm would incur this burden, totaling 75 minutes of burden per company. In addition, EPA estimates that a manager would spend an additional 30 minutes accessing, preparing, and submitting verification forms (Verification of Authorization) for all authorized submitters to EPA. The total burden incurred by firms submitting and then verifying electronic signature agreements would be 105 minutes. It should be noted that the burden associated with CDX Electronic Signatures does not include costs associated with contacting EPA's CDX help desk to notify a change of submitter status, should one occur.

Table 7. Estimated Burden Associated with New CDX Registration Activities
                            Information Collection
                    Estimated Number of Annual Respondents
                             Number of Responses/
                                  Respondent
                 Estimated Burden Hours and Cost per Response
                         Estimated Burden Hours /Year

                          Estimated Labor Cost /Year

                                  Managerial
                                   Technical

                                     Hours
                                   Wage Rate
                                     Hours
                                   Wage Rate

CDX Registration & E-signature
                                       4
                                       1
                                     0.93
                                    $83.15
                                     1.73
                                    $78.08
                                      11
                                     $851

      Non-labor costs include a $0.49- stamp and a $0.03 standard business envelope for each of five required electronic signature agreements. The total non-labor cost for electronic signature agreements equals $2.60. This amounts to $10.40 in non-labor costs per year.

      Conservatively assuming that all 4 firms submitting studies will need to register with CDX, the average burden and cost per CDX registration is 2.75 hours and $212.75, respectively.

      6(f)	Estimating Agency Cost

      The activities routinely conducted by EPA related to processing and storage of the information collected under this rule include processing and analyzing the materials submitted under the rule, including requests for confidentiality; and maintaining and distributing data.

      The activities associated with Agency responses to TSCA section 8(d) listings are assumed to be accomplished by a GS 13, Step 5 federal employee. The 2017 hourly wage rate for this level of employee in the Washington, D.C. locality is $51.48 per hour. Adding 60% for benefits and overhead yields a loaded annual wage rate of $82.36 per hour.

      The estimated annual cost to the federal government for TSCA section 8(d) data collection totals $4,813.94 for 58.45 hours, as presented in Table 8.

Table 8. Agency Annual Cost Estimates

                              Collection Activity
                                     FTEs
                                    Hours
                                  Annual Cost
Data processing and system support
                                     0.025
                                     41.75
                                  $3,438.53
Storage and distribution
                                     0.010
                                     16.70
                                   $1,375.41
                                    TOTALS
                                     0.035
                                     58.45
                                   $4,813.94
Source: OPM 2017 hourly rate table for the Washington-Baltimore-Northern Virginia Locality Pay Area, with 60% for benefits and overhead added.

      6(g)	Bottom Line Burden Hours and Cost

      As shown in Table 6, if EPA adds 13 chemicals per year to the TSCA section 8(d) list during the time period covered by this ICR, burden associated with section 8(d) review and reporting will be incurred by 4 firms. Note that not all these firms incur every aspect of reporting burden. Those firms that do ultimately submit studies incur a small amount of additional burden and cost associated with registering with CDX in order to comply with new electronic reporting requirements. The burden activities associated with CDX registration occur only once, during the first year of the ICR period.

      The average annual reporting burden and cost per response is estimated at 11 hours and $907, respectively, with overall estimated annual totals of 291 burden hours and $23,584. Conservatively assuming that all firms submitting studies will need to complete a one-time CDX registration, the average annual burden and cost per CDX registration is 2.75 hours and $212.75, respectively. This yields an estimated annual burden and cost per response for CDX-related activities of 11 hours and $851.

      As noted earlier, basing the future burden estimates on the reporting from the 2006 and 2008 section 8(d) rules may overestimate reporting burden and cost if number and characteristics of the chemicals that are added to the TSCA section 8(d) list during the next three years are less burdensome than the chemicals that were added in 2006 and 2008.

      The total annual respondent burden and cost for this collection (sum of Tables 6 and 7) is 302 hours and $24,435 respectively.

      6(h)	Reasons for Changes in Burden

      Although CBI substantiation has added 31.5 burden hours per year to the total estimated burden, there is an overall net decrease of 1,303 hours (from 1,605 to 302) in the total estimated respondent burden compared with that currently in the OMB inventory. This net decrease in burden is due to the following:
 This ICR assumes that a historical average (from 1996 to present) of 13 chemicals will be added to the section 8(d) list over the next three years.
 The previous ICR based the average number of chemicals to be added to the section 8(d) list on the period from 2006  -  2015.  In 2006, 208 chemicals were added to the list, the largest addition since 1996.
 The final section 8(d) rule issued on January 20, 2008 (73 FR 5190) added 12 Lead and Lead Compounds to 40 CFR 716 120 was included in this ICR.
 The number of chemicals added to the section 8(d) list has been zero since 2008.
 The methodology used in the previous ICR overestimated the burden resulting from the addition of chemicals to the TSCA section 8(d) rule.

      6(i)	Burden Statement

      The annual public burden for this collection of information, which is approved under OMB Control No. 2070-0004, is estimated to average about 11 hours per response. Burden is defined in 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 number for this information collection appears above. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9 and included on the related collection instrument or form, if applicable.

      The Agency has established a public docket for this ICR under Docket ID No. EPA-HQ-OPPT-2017-0646 which is available for online viewing at www.regulations.gov, or in-person viewing at the Pollution Prevention and Toxics Docket in the EPA Docket Center (EPA/DC). The EPA/DC Public Reading Room is located in the West William Jefferson Clinton Bldg., Room 3334, 1301 Constitution Ave., N.W., Washington, DC. The EPA/DC Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the EPA/DC Public Reading Room is<PHONE_NUMBER>, and the telephone number for the Pollution Prevention and Toxics Docket is<PHONE_NUMBER>.

      You may submit comments regarding the Agency's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden, including the use of automated collection techniques. Submit your comments, referencing Docket ID No. EPA-HQ-OPPT-2017-0646 and OMB Control No. 2070-0004, to (1) EPA online using www.regulations.gov (our preferred method), or by mail to: Pollution Prevention and Toxics Docket, Environmental Protection Agency Docket Center (EPA/DC), Mailcode: 28221T, 1200 Pennsylvania Ave., N.W., Washington, DC 20460, and (2) OMB by mail to: Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, N.W., Washington, DC 20503.

                    ATTACHMENTS TO THE SUPPORTING STATEMENT

	Attachments to the supporting statement are available in the public docket established for this ICR under docket identification number EPA-HQ-OPPT-2017-0646 These attachments are available for online viewing at www.regulations.gov or otherwise accessed as described in section 6(f) of the supporting statement.

Attachment 1:	15 U.S.C. 2607(d) - Section 8(d) of the Toxic Substances Control Act.
            	Also available online at the U.S. House of Representatives' U.S. Code website

Attachment 2:	40 C.F.R. part 716 - Health and Safety Data Reporting. Also available online at the National Archives and Records Administration's Electronic CFR website


   1) Please provide a detailed outline of the provisions of this rulemaking that deviate from the recommendations of ICAO and provide a detailed justification and policy rationale for why EPA is proposing to deviate from these recommended standards.  The United States has an obligation under the Article 2.4 TBT Agreement to follow international standards unless those standards would be ineffective and inappropriate.  Specifically, Article 2.4 states,
            "Where technical regulations are required and relevant international standards exist or their completion is imminent, Members shall use them, or the relevant parts of them, as a basis for their technical regulations except when such international standards or relevant parts would be an ineffective or inappropriate means for the fulfilment of the legitimate objectives pursued, for instance because of fundamental climatic or geographical factors or fundamental technological problems."

   2) How did EPA choose which non-attainment areas to display in Table 4 on page 25?  Why are areas that encompass some of the Nation's larger "hub" airports (such as Boston, New York and Dallas-Fort Worth) not included?

   3) It is acknowledged that section 233 of the Clean Air Act preempts States from adopting or enforcing any aircraft engine emissions standard unless such standard is identical to EPA's.  Nonetheless, because EPA is proposing to revise text in the Code of Federal Regulations with respect to this statutory preemption, additional discussion addressing EPA's argument that this rule will not have federalism implications under Executive Order 13132 would be helpful.   At a minimum, EPA should clarify the explanation provided on page 131 to remove some apparent inconsistencies in the text.  Suggested revisions are:
            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 proposes to revise 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 merely modifies existing EPA aircraft engine emission standards and test procedures and therefore will merely continue an existing preemption of State and local law.   Thus, Executive Order 13132 does not apply to this action.
   4) In the discussion in the preamble about military engines, EPA states that it is "not proposing any specific provisions with respect to engines installed on military aircraft," explaining that such aircraft fall outside the scope of the emissions rules by operation of the regulatory language that brings covered aircraft within the rules (because the FAA rules do not require the certification of military engines). In the table on page 114, however, EPA suggests that proposed § 87.1 ("Definitions") contains a definition of "military aircraft." In fact, consistent with the earlier discussion, there is no such definition in § 87.1.

   5) Recommend revising the table to cite § 87.3 ("General applicability and requirements"), since it really pertains to applicability and since it doesn't actually refer to any particular definition in § 87.1. For consistency with the statutory FAA provisions, EPA may also wish to use the terminology in 49 USC § 40125(c), i.e. "aircraft owned or operated by the armed forces." The note in the table on page 114 might be revised to say, for instance, "The regulations of this part do not apply to aircraft owned or operated by the Armed Forces, including aircraft owned by the U.S. Coast Guard, as well as some other aircraft not owned by DoD."

Whether or not EPA changes the cite or uses the terminology in 49 U.S.C., EPA's clarification in the preamble that military/armed forces aircraft are not covered by the rules and that such aircraft includes non-DoD aircraft is very helpful and much appreciated.

   6) Recommend adding the words "that are required to be" to § 87.3(a) to read: "The regulations of this part apply to engines on all aircraft that are required to be certificated by FAA under 14 CFR part 34 except as specified...."  In the preamble, EPA points out that manufacturers sometimes voluntarily certify engines that FAA does not require to be certificated and clarifies that it is EPA's intent to exclude engines which FAA does not require to be certificated, whether or not they are, in fact, certificated. The proposed language does not, however, say that and could be read that voluntary certification brings an engine within the purview of the regulations.

   7) Recommend checking the internal cross-reference in §87.1 to ensure it is the correct cite.

   8) The draft rule contains provisions that may exceed reasonable interpretations of the statutory phrase "standards applicable to the emission of any air pollutant" (standards).  If everything in the draft rule is considered a standard, an obligation would be created under CAA section 7572 for other agencies besides EPA to adopt and implement through their authorities.

   9) The EPA has proposed that a new annual report be submitted by engine manufacturers detailing the production of various engine models.  Much of this information is available elsewhere.  It is unclear whether the report can be viewed as a standard, and there does not appear to be a clear regulatory need for the report.  Can EPA provide a clear rationale for why this report would be required, or consider not requiring this report?  What specifically would the information be used for?  Would collecting this information require approval under the Paperwork Reduction Act?

   10) The EPA has proposed a new "exemption" process under which manufacturers could continue to produce certain engines after the standards have changed.  In general, industry usage of exemptions has remained low. The new process includes joint filings and unclear lines of authority and decision.  It appears inconsistent in its use of terms that are well known in the industry, and attaches new concepts to them.  No attempt has been made to detail the costs of the new process to other agencies, or to industry applicants.

   11) Similarly, the EPA proposes a new designation of "exempt-spare" engines that may be produced outside of production limits.  The draft rule does not account for how this would impact certification processes and regulations of other agencies.  The draft rule does not acknowledge the regulatory requirements or their costs that would fall on other agencies from adopting a new category of engine marking, and a new system by which the EPA expects them to be traceable. The concept of installing a "spare" engine presumes there is a system in place by which individual engines are tracked on individual aircraft by operations.  The reality is that there is no such system in place to track engines with this new designation. The rule contains no acknowledgement of the cost that could result from a full consideration of such a requirement, including the tremendous cost on the FAA to promulgate and implement such a system.

   12) EPA requests comment on a proposed "voluntary" emissions credit program.  EPA has not acknowledged the lack of regulatory infrastructure on which to overlay such a program, or the fact that they intend for other agencies to administer it under its own regulations.   Moreover, the offset program applies to engine manufacturers getting credit for producing a certain number of better engines in trade for ones that pollute more.  However, manufacturers do not know or control where their engines are operated, nor can the presumption be made that all are operated the same amount, producing a comparable amount of pollutant.   The idea is based on an unstated presumption that there will be some benefit in the United States, or even in certain domestic areas.  It is further tied into the unclear exemption process described previously.  The cost of such a system is not described, nor is the presumed benefit of its existence.

   13) It is unclear why EPA is proposing to include ICAO guidance material (known as the Environmental Technical Manual or ETM for emissions) in the regulatory text.  Adoption of international guidance material eliminates valid means of regulatory guidance already in place, changes it from advisory to mandatory (which was not ICAO's intent) and eliminates compliance flexibility.  A clear example is EPA's proposal regarding what constitutes a derivative engine, which was clearly intended as guidance.  No accounting for costs to other Agencies for implementing this requirement or industry compliance is accounted for.  From a broader governmental perspective, this is an issue that goes beyond emissions, and would set a dangerous precedent.  ICAO guidance material is not designed to function as mandatory regulation, and often embodies compromises that the U.S. agrees to only because it is adopted as guidance.  If the U.S. turns guidance into regulations, it could tempt others to adopt, as regulations, ICAO guidance material that we object to.  It would also undermine countries' willingness to adopt guidance material in the future.

   14) In discussing the inclusion of ICAO materials, the draft rule engages in a discussion of "commercial" and "non-commercial" aircraft engines.  The distinction between an engine used in commercial operation vs. non-commercial operation has no basis in the reality of regulated aircraft operations.  An individual aircraft, for example, can switch status between flights.  From a broader perspective, creating commercial and non-commercial definitions by classes of equipment rather than usage would also set a dangerous precedent, and would conflict with existing statutory and regulatory definitions.

   15) The draft rule includes the adoption of technical appendices to ICAO standards and recommended practices.  EPA's adoption of these standards through incorporation by reference (IBR) is inappropriate as there are legal implications of proper notice, the requirement to access a foreign publication to properly understand the requirements of a codified standard, and even language and format. There are also issues of cost in adopting the technical changes that the EPA does not acknowledge.

   16) In several places, the proposed rule discusses military aircraft engines.  While certain engine manufacturers certify engines that have both military and civilian applications, these are generally treated as civilian and under existing regulatory authorities.  If the EPA finds that their authority extends to engines produced only for installation on military airplanes, then that regulation should remain within their sole jurisdiction and not be considered a standard that other agencies will adopt or enforce.

   17) It is several reviewers' view that the EPA draft would require another federal agency to change its regulatory approach, add scope and costs to regulatory oversight with unclear benefits, incorporate practices not endorsed by aviation's international standard-setting body, and produce confusion and misunderstanding in a global industry.  There is no acknowledgment of the costs associated with such regulations, the changes to the current regulations, the burdens placed on other agencies for adoption and implementation, and no consideration of what benefits from the changes might accrue.  If the EPA chooses to adopt them as its regulations alone, the provisions would be at considerable odds with the current regulatory system of aircraft engine certification in place under existing regulations. One approach at least one reviewer recommends would be for EPA to limit its rulemaking proposal to adopting only the ICAO oxides of nitrogen (NOx) emissions standards agreed upon at the CAEP/6 and CAEP/8 meetings. This approach could be implemented similarly to other historical ICAO CAEP outcomes.

   18)  The proposed rule does not indicate the fact that this EPA CAA rulemaking is subject to CAA section 307(d), 42 USC 7607(d).

   19) "...§87.44 Reporting CO2 emissions. (a)(1) For any type certificates involving compliance with NOx emission standards that are issued on or after January 1, 2014, you must report CO2 emissions to the Designated EPA Program Officer. You may include this information in the certification report described in §87.42 or in a separate submission.
   (2) For any type certificates involving compliance with NOx emission standards that are issued before January 1, 2014, you must report CO2 emissions along with your emission levels of regulated NOx to the Designated EPA Program Officer.
   (b) Determine CO2 emission rates by direct measurement or by calculation from measured fuel mass flow rates for CO2 emissions from fossil and biogenic sources separately.  These methods are described in Appendices 3 and 5 to ICAO Annex 16 (incorporated by reference in §87.8).  Report CO2 emissions separately for each operating mode.  If you test more than one engine, report the average value of CO2 emissions for each operating mode.  Round CO2 emissions of CO2 emissions from fossil and biogenic sources to the nearest whole gram and gram/kilonewton..."
Typos
   Page 12:  Specifically, reports would be required for turbofan engines with rated thrusts greater than 26.7 kN , which are subject to gaseous emission and smoke standards.....
   Page 15:  States may ban the use of any aircraft within their airspace that does not meet ICAO standards.   Second, States are required to recognize the airworthiness certificates of any State whose standards are at least as stringent as ICAO's standards, thereby assuring that it's the aircraft of any member State will be permitted to operate in any other member State.
   Page 28:  The ICAO NOx standards that with which we propose are proposing to align with will help reduce ambient ozone and secondary PM levels and thus will help areas with airports achieve and/or maintain compliance with the National Ambient Air Quality Standards (NAAQS).