[Federal Register: August 12, 2009 (Volume 74, Number 154)]
[Proposed Rules]
[Page 40525-40527]
[DOCID:fr12au09-19]

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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-0685; Directorate Identifier 2009-NM-113-AD]
RIN 2120-AA64

Airworthiness Directives; McDonnell Douglas Model DC-9-30, DC-9-
40, and DC-9-50 Series Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain McDonnell Douglas Model DC-9-30, DC-9-40, and DC-9-50 series
airplanes. This proposed AD would require inspecting to determine the
part numbers of the forward and aft auxiliary tank fuel boost and
transfer pump conduit/conduit assembly and conduit assembly electrical
connector, as applicable, and corrective actions if necessary. This
proposed AD results from fuel system reviews conducted by the
manufacturer. We are proposing this AD to detect and correct the
potential for an arc/spark condition to occur within the fuel boost or
transfer pump conduit assembly connectors and propagate into the
forward and aft auxiliary fuel tanks, which could result in a fire or
explosion.

DATES: We must receive comments on this proposed AD by September 28,
2009.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, 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 service information identified in this proposed AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
3855 Lakewood Boulevard, MC D800-0019, Long Beach, California 90846-
0001; telephone<PHONE_NUMBER>, extension 2; fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>Internet https://www.myboeingfleet.com. You may
review copies of the referenced service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at the
FAA, call<PHONE_NUMBER> or<PHONE_NUMBER>.

Examining the AD Docket

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

FOR FURTHER INFORMATION CONTACT: William Bond, Aerospace Engineer,
Propulsion Branch, ANM-140L, FAA, Los Angeles Aircraft Certification
Office, 3960 Paramount Boulevard, Lakewood, California 90712-4137;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2009-0685;
Directorate Identifier 2009-NM-113-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The FAA has examined the underlying safety issues involved in fuel
tank explosions on several large transport airplanes, including the
adequacy of existing regulations, the service history of airplanes
subject to those regulations, and existing maintenance practices for
fuel tank systems. As a result of those findings, we issued a
regulation titled ``Transport Airplane Fuel Tank System Design Review,
Flammability Reduction and Maintenance and Inspection Requirements''
(66 FR 23086, May 7, 2001). In addition to new airworthiness standards
for transport airplanes and new maintenance requirements, this rule
included Special Federal Aviation Regulation No. 88 (``SFAR 88,''
Amendment 21-78, and subsequent Amendments 21-82 and 21-83).
    Among other actions, SFAR 88 requires certain type design (i.e.,
type certificate (TC) and supplemental type certificate (STC)) holders
to substantiate that their fuel tank systems can prevent ignition
sources in the fuel tanks. This requirement applies to type design
holders for large turbine-powered transport airplanes and for
subsequent modifications to those airplanes. It requires them to
perform design reviews and to develop design changes and maintenance
procedures if their designs do not meet the new fuel tank safety
standards. As explained in the preamble to the rule, we intended to
adopt airworthiness directives to mandate any changes found necessary
to address unsafe conditions identified as a result of these reviews.
    In evaluating these design reviews, we have established four
criteria intended to define the unsafe conditions associated with fuel
tank systems that require corrective actions. The percentage of
operating time during which fuel tanks are exposed to flammable
conditions is one of these criteria. The other three criteria address

the failure types under evaluation: single failures, single failures in
combination with a latent condition(s), and in-service failure
experience. For all four criteria, the evaluations included
consideration of previous actions taken that may mitigate the need for
further action.
    We have determined that the actions identified in this AD are
necessary to reduce the potential of ignition sources inside fuel
tanks, which, in combination with flammable fuel vapors, could result
in fuel tank explosions and consequent loss of the airplane.
    It was determined by the SFAR 88 review that failure could occur in
the forward and aft auxiliary tanks due to damage of the fuel boost or
transfer pump conduit assembly connectors. Damage has been attributed
to maintenance personnel loosening or tightening the conduit assembly
by turning the round or hex fitting part of the conduit instead of the
electrical connector square nut. Turning the round part of the conduit
can break the seal and permit fuel to enter the conduit and connector.
Fuel contacting the connector insert causes the insert material to
swell, allowing the socket to become loose, resulting in pin and socket
misalignment when reconnected to the pump. This condition, if not
corrected, could result in an arc/spark condition in the fuel boost or
transfer pump conduit assembly connectors, that could propagate into
the forward and aft auxiliary fuel tanks, which could result in a fire
or explosion.

Relevant Service Information

    We have reviewed Boeing Service Bulletin DC9-28-227, dated April
23, 2009. The service bulletin describes procedures for inspecting to
determine the part numbers of the forward and aft auxiliary tank fuel
boost or transfer pump conduit/conduit assembly and conduit assembly
electrical connector. Corrective actions include replacing or repairing
conduit assemblies and conduit assembly electrical connectors having
certain part numbers.

FAA's Determination and Requirements of This Proposed AD

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

Costs of Compliance

    We estimate that this proposed AD would affect 137 airplanes of
U.S. registry. We also estimate that it would take up to 8 work-hours
per product to comply with this proposed AD. The average labor rate is
$80 per work-hour. Based on these figures, we estimate the cost of this
proposed AD to the U.S. operators to be $87,680, or $640 per product.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866,
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979), and
    3. 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.
    You can find our regulatory evaluation and the estimated costs of
compliance in the AD Docket.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

McDonnell Douglas: Docket No. FAA-2009-0685; Directorate Identifier
2009-NM-113-AD.

Comments Due Date

    (a) We must receive comments by September 28, 2009.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Model DC-9-31, DC-9-32, DC-9-32 (VC-9C),
DC-9-32F, DC-9-33F, DC-9-34, DC-9-34F, and DC-9-32F (C-9A, C-9B),
DC-9-41, and DC-9-51 airplanes, certificated in any category, as
identified in Boeing Service Bulletin DC9-28-227, dated April 23,
2009.

Subject

    (d) Air Transport Association (ATA) of America Code 28: Fuel.

Unsafe Condition

    (e) This AD results from fuel system reviews conducted by the
manufacturer. The Federal Aviation Administration is issuing this AD
to detect and correct the potential for an arc/spark condition to
occur within the fuel boost or transfer pump conduit assembly
connectors and propagate into the forward and aft auxiliary fuel
tanks, which could result in a fire or explosion.

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Inspection

    (g) Within 60 months after the effective date of this AD,
inspect to determine the part numbers of the forward and aft
auxiliary fuel tank boost and transfer pumps conduit assembly and
conduit assembly electrical connector, as applicable, and do
applicable corrective actions, in accordance with the Accomplishment
Instructions of Boeing Service Bulletin DC9-28-227, dated April 23,
2009. Do the applicable corrective actions before further flight.

Alternative Methods of Compliance (AMOCs)

    (h)(1) The Manager, Los Angeles Aircraft Certification Office
(ACO), FAA, has the authority to approve AMOCs for this AD, if

requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: William Bond, Aerospace Engineer, Propulsion
Branch, ANM-140L, FAA, Los Angeles ACO, 3960 Paramount Boulevard,
Lakewood, California 90712-4137; telephone<PHONE_NUMBER>; fax (562)
627-5210.
    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your principal maintenance inspector (PMI) or
principal avionics inspector (PAI), as appropriate, or lacking a
principal inspector, your local Flight Standards District Office.
The AMOC approval letter must specifically reference this AD.

    Issued in Renton, Washington, on August 3, 2009.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E9-19265 Filed 8-11-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 181 (Monday, September 19, 2016)]
[Notices]
[Pages 64171-64175]
[FR Doc No: 2016-22442]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3326]

Biosimilar User Fee Act; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a public meeting to discuss proposed recommendations for the
reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years
(FYs) 2018 through 2022. BsUFA authorizes FDA to collect fees and use
them for the process for the review of biosimilar biological product
applications. The current legislative authority for BsUFA expires in
September 2017. At that time, new legislation will be required for FDA
to continue collecting biosimilar

biological product user fees in future fiscal years. Following an
initial consultation with public stakeholders and discussions with the
regulated industry, the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) directs FDA to publish the recommendations for the reauthorized
program in the Federal Register, hold a meeting at which the public may
present its views on such recommendations, and provide for a period of
30 days for the public to provide written comments on such
recommendations. FDA will then consider the public views and comments
and revise the recommendations as necessary.

DATES: The public meeting will be held on October 20, 2016, from 9 a.m.
to 2 p.m. Please register for the meeting by October 19, 2016, at
http://bsufapublicmeeting.eventbrite.com. Submit electronic or written
comments to the public docket by October 19, 2016.

ADDRESSES: The meeting will be held at the FDA White Oak Campus, 10903
New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (rm.
1503, Section A), Silver Spring, MD 20993-0002. Participants must enter
through Building 1 and undergo security screening. For more information
on parking and security procedures, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-N-3326 for ``Biosimilar User Fee Act; Public Meeting.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    FDA will post the agenda approximately 5 days before the meeting
at: http://www.fda.gov/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/ucm461774.htm.

FOR FURTHER INFORMATION CONTACT: Amanda Roache, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1176, Silver Spring, MD 20993, 301-796-
4548, FAX:<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Introduction

    FDA is announcing a public meeting to discuss proposed
recommendations for the reauthorization of BsUFA, the legislation that
authorizes FDA to collect user fees and use them for the process for
the review of biosimilar biological product applications. The current
authorization of the program (BsUFA I) expires in September 2017.
Without new legislation, FDA will no longer be able to collect user
fees for future fiscal years to fund the process for the review of
biosimilar biological product applications. Section 744I(e)(2) of the
FD&C Act (21 U.S.C. 379j-53(e)(2)) requires that after FDA holds
negotiations with regulated industry, we do the following: (1) Present
recommendations to the relevant Congressional committees, (2) publish
recommendations in the Federal Register, (3) provide a period of 30
days for the public to provide written comments on the recommendations,
(4) hold a meeting at which the public may present its views on the
recommendations, and (5) after consideration of public views and
comments, revise the recommendations as necessary.
    This notice, the 30-day comment period, and the public meeting will
satisfy some of these requirements.
    The purpose of the meeting is to hear the public's views on the
proposed recommendations for the reauthorization of BsUFA II. The
following information is provided to help potential meeting
participants

better understand the history and evolution of the BsUFA program and
the proposed BsUFA II recommendations.

II. What is BsUFA and what does it do?

    BsUFA is a law that authorizes FDA to collect fees from drug
companies that submit marketing applications for certain biosimilar
biological products. BsUFA was originally enacted in 2012 as the
Biosimilar User Fee Act (Pub. L. 112-144) for a period of 5 years.
    BsUFA's intent is to provide additional revenues so that FDA can
hire more staff, improve systems, and establish a better-managed
biosimilar biological product review process to make important
therapies available to patients sooner without compromising review
quality or FDA's high standards for safety, efficacy, and quality. As
part of FDA's agreement with industry during each reauthorization, the
Agency agrees to certain performance goals. These goals apply to the
process for the review of new biosimilar biological product
applications, resubmissions of original applications, and new and
resubmitted supplements to approved applications. Phased in over the 5
years of BsUFA I, the goals were to review and act on 90 percent of
original biosimilar biological product application submissions within
10 months of receipt and resubmitted original biosimilar biological
product applications within 6 months of receipt; to review and act on
90 percent of original supplements with clinical data within 10 months
of receipt and resubmitted supplements with clinical data within 6
months of receipt; and review and act on 90 percent of manufacturing
supplements within 6 months of receipt.

III. Proposed BsUFA II Recommendations

    In preparing the proposed recommendations to Congress for BsUFA
reauthorization, FDA conducted discussions with the regulated industry
and consulted with stakeholders, as required by the law. We began the
BsUFA reauthorization process by publishing a notice in the Federal
Register requesting public input on the reauthorization and announcing
a public meeting that was held on December 18, 2015. The meeting
included presentations by FDA and a series of panels with
representatives of different stakeholder groups, including patient
advocates, consumer groups, regulated industry, health professionals,
and academic researchers. The materials from the meeting, including a
transcript and Webcast recording, can be found at http://www.fda.gov/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/ucm461774.htm.
    Following the December 2015 public meeting, FDA conducted
negotiations with the regulated industry from March 2016 through May
2016. FDA posted minutes of these meetings on its Web site at http://www.fda.gov/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/ucm461774.htm.
    The proposed enhancements for BsUFA II address many of the top
priorities identified by public stakeholders, the regulated industry,
and FDA. While some of the proposed enhancements are new, many either
build on successful enhancements or refine elements from the existing
program. The enhancements are proposed in the following areas: Review
performance, meeting management, guidance development, and
administrative areas (hiring and financial management). The full text
of the proposed BsUFA II commitment letter can be found here at http://www.fda.gov/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/ucm461774.htm. Each significant new or modified enhancement is
described briefly in sections III.A through III.K.

A. The Review Cycle

    FDA and the regulated industry jointly identified an opportunity to
reduce multiple review cycles for biosimilar biological products by
increasing transparency and communication during the review process of
a 351(k) application. For BsUFA II, it is therefore proposed to
establish a model for the review of biosimilar biological products
similar to the Program for Enhanced Review Transparency and
Communication for New Molecular Entity New Drug Applications and
original Biologics License Applications (the Program) that was
established in the fifth authorization of the Prescription Drug User
Fee Act (PDUFA).
    The Program was first established for PDUFA in 2012. An interim
assessment of the Program suggested that it has created conditions that
enhance the ability of applicants and FDA reviewers to work toward
application approval in the first cycle (see http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm327030.htm). Likewise,
it is anticipated that the review model will promote efficiency and
effectiveness of the first cycle review process and minimize the number
of review cycles necessary for approval for 351(k) applications.
    The Program will allow for additional communication between FDA
review teams and the applicants of biosimilar biological products in
the form of pre-submission meetings, mid-cycle communications, and
late-cycle meetings, while also adding 60 days to the review timeframe
to accommodate this additional interaction.
    This enhancement is described in section I.B. of the proposed BsUFA
II commitment letter.

B. Review Goal Extension for Missing Manufacturing Facilities

    When manufacturing facilities are not adequately identified, this
may result in the need for FDA to conduct inspections late in the
review process. This can adversely impact FDA's ability to complete
application review within the performance goal timeframes. Accordingly,
FDA proposes to extend the goal date for an original application or a
supplement when FDA identifies a need to inspect a facility that was
not included in a comprehensive and readily located list of
manufacturing facilities. This enhancement is described in section
I.A.5.b of the proposed BsUFA II commitment letter.

C. Special Protocol Assessment and Agreement

    Further clarity is needed regarding the types of clinical study
protocols that may qualify for a Special Protocol Assessment and
Agreement under BsUFA. Pharmacokinetic (PK) and Pharmacodynamic (PD)
similarity studies should be added to the examples provided in the
goals letter. It is proposed that the language in the goals is revised
to include PK and PD similarity studies. This enhancement is described
in section I.H.1.c of the proposed BsUFA II commitment letter.

D. Prior Approval Manufacturing Supplements

    The review goal date for biosimilar prior approval manufacturing
supplements is currently 6 months under BsUFA I, compared to 4 months
for stand-alone biologics under PDUFA. Therefore, to increase
consistency among user fee programs, it is proposed that prior approval
manufacturing supplements are reviewed in 4 months, instead of 6
months, with a phased-in performance goal. The language for prior
approval supplements is included in section I.A.3 of the proposed BsUFA
II commitment letter.

E. Meeting Management

    The enhancements in this section focus on FDA's ability to better
manage meetings with sponsors of 351(k) applications. The details for
these enhancements can be found in section

I.I of the proposed BsUFA II commitment letter.
1. Addition of a Written Response Meeting Format for Biosimilar Initial
Advisory (BIA) and Biosimilar Program Development (BPD) Type 2 Meetings
    Currently, there is no mechanism to grant a meeting request and
provide a written response in place of a face-to-face meeting,
videoconference, or teleconference. From FY 2013 to FY2015, FDA
provided written responses to sponsors for 16 out of 22 meetings that
were denied or cancelled due to incomplete, premature, or unnecessary
requests in order to support biosimilar development programs. Such
responses are not on a user fee clock and are not tracked work. For
BsUFA II, it is proposed that for BIA and BPD Type 2 meetings, the
sponsor may request a written response to questions rather than a face-
to-face meeting, videoconference, or teleconference. If a written
response is deemed appropriate, FDA will notify the requester of the
date it intends to send the written response. This date will be
consistent with the timeframes specified for the specific meeting type.
2. Increase the Scheduling Timeframe for BPD Type 2 Meetings
    The FDA has had challenges scheduling BPD type 2 meetings within
the 75-day timeframe. Scheduling challenges occur due to an increasing
number of Type 2 meetings to discuss novel and complex aspects of
development that require extensive internal discussion. A review
committee must address many of these aspects to ensure implementation
of consistent scientific advice and policy concerning biosimilar
development. Consequently, FDA is unable to answer and provide
comprehensive responses to such questions at meetings within the 75-day
timeframe. This results in unresolved issues and additional followup
questions that ultimately leads to a delay in a sponsor's overall
development program. To provide the necessary time for FDA discussions
and to develop comprehensive responses, it is proposed that BPD Type 2
Meetings occur within 90 calendar days, instead of 75 days, from
receipt of the meeting request and meeting package with a phased in
performance goal. Additionally, it is proposed that the Agency will
send preliminary responses to the sponsor's questions contained in the
background package no later than five calendar days before the face-to-
face videoconference or teleconference meeting date for BPD Type 2 and
Type 3 meetings.
3. Reduce the Scheduling Timeframe for Biosimilar Initial Advisory
(BIA) Meetings
    On average, five BIA meetings were scheduled per fiscal year from
2013 to 2015. The content of a BIA meeting is limited to a general
discussion on whether a proposed product could be developed as a
biosimilar product and to provide high-level advice on the expected
content of the development program. Targeted advice on the adequacy of
any comparative data or extensive advice for any aspect of an ongoing
biosimilar development program is not expected to be provided in a BIA
meeting. The current 90-day scheduling timeframe may no longer be
appropriate and should be shortened. Therefore, it is proposed for BIA
meetings to occur within 75 calendar days, instead of 90 days, from
receipt of the meeting request and meeting package.

F. Guidance Development

    FDA has received feedback that additional clarity is needed on
regulatory processes and the scientific criteria for biosimilar
development and approval to provide certainty to industry and other
stakeholders related to Agency expectations. Therefore, it is proposed
that FDA revise its guidance entitled ``Formal Meetings Between the FDA
and Biosimilar Biological Product Sponsors or Applicants'' and update
the draft guidance entitled ``Best Practices for Communication Between
IND Sponsors and FDA During Drug Development'' to include
communications between IND sponsors and FDA during biosimilar
biological product development. Additionally, it is proposed that FDA
publish draft or final guidance on several issues related to biosimilar
biological product development including considerations in
demonstrating interchangeability with a reference product; statistical
considerations for analytic similarity for biosimilar biological
products; processes and further considerations related to post-approval
manufacturing changes for biosimilar biological products; clinical
pharmacology data to support a demonstration of biosimilarity to a
reference product; nonproprietary naming of biological products; and
labeling for biosimilar biological products. The proposed goals related
to guidance development are described in sections I.I.6 and II of the
proposed BsUFA II commitment letter.

G. Improving FDA Hiring and Retention of Review Staff

    To speed and improve development of safe and effective biosimilar
biological products for patients, FDA must hire and retain sufficient
numbers and types of technical and scientific experts to efficiently
conduct reviews of 351(k) applications. In order to strengthen this
core function during BsUFA II, FDA proposes to implement a full time
equivalent staff-based position management system capability and an
online position classification system. In addition, FDA will complete
implementation of corporate recruiting practices, augment hiring
capacity with expert contractor support, establish a dedicated function
for staffing of the human drug review program, establish clear goals
for biosimilar review program hiring, and conduct comprehensive and
continuous assessments of hiring and retention performance. These
enhancements are described in section V of the proposed BsUFA II
commitment letter.

H. Enhancing Capacity for Biosimilar Guidance Development, Reviewer
Training, and Timely Communication

    In order to accelerate patient access to safe and effective
biosimilar biological products and ensure accuracy, consistency, and
timeliness FDA needs a more focused and better resourced capacity to
coordinate key legal, scientific, review, and outreach functions in
FDA's development phase advice and premarket review. It is proposed
that FDA strengthen its staff capacity to: (1) Develop new regulations
and guidance to clarify scientific criteria for biosimilar development
and approval, and to provide certainty to industry and other
stakeholders on key regulatory issues including the scope of eligible
biosimilar biological products; (2) develop or revise manuals of policy
and procedures, standard operating procedures, and review templates to
facilitate rapid update and application of new policies and guidance by
review staff, and to develop and deliver timely, comprehensive training
to all Center for Drug Evaluation and Research and Center for Biologics
Evaluation and Research review staff and special government employees
involved in the review of 351(k) BLAs; (3) deliver timely information
to the public to improve public understanding of biosimilarity and
interchangeability; and (4) deliver information concerning the date of
first licensure and the reference product exclusivity expiry date, to
be included in the Purple

Book.\1\ The language for enhanced capacity is included in section III
of the proposed BsUFA II commitment letter.
---------------------------------------------------------------------------

    \1\ The ``Purple Book'' lists biological products, including any
interchangeable biological products, licensed by FDA under the
Public Health Service Act.
---------------------------------------------------------------------------

I. Enhancing Management of User Fee Resources

    FDA is committed to enhancing management of BsUFA resources and
ensuring BsUFA user fee resources are administered, allocated, and
reported in an efficient and transparent manner. In BsUFA II, FDA
proposes to establish a resource capacity planning function to improve
its ability to analyze current resource needs and project future
resource needs, to modernize its time reporting approach, to conduct an
evaluation of BsUFA program resource management, to publish a 5-year
BsUFA financial plan with annual updates, and to convene an annual
public meeting, beginning in FY 2019, to discuss the financial plan and
progress towards the financial management enhancements. FDA also
proposes to reduce the carryover balance to no greater than 21 weeks of
the FY 2022 target revenue by the end of FY 2022. These enhancements
are described in section IV of the proposed BsUFA II commitment letter.

J. Enhancements to Fee Structure and Related Mechanisms for Increased
Predictability, Stability, and Efficiency

    The current BsUFA fee structure references PDUFA fees each fiscal
year and calculates biosimilar biological product development program
(BPD) fees based on the PDUFA application fee. FDA and industry agreed
that the BsUFA II fee structure and the fee setting process could be
updated to enhance the predictability and stability of fee amounts and
revenues in a manner to improve FDA's ability to engage in long-term
financial planning. To address these issues, FDA proposes to
discontinue the reduction of the biosimilar biological product
application fee by the cumulative BPD fees paid by sponsors, to
discontinue the establishment and supplement fees, to rename the
product fee as the BsUFA Program fee, to modify the Program fee billing
date to minimize the need for multiple billing cycles, and to add a
limitation that a sponsor shall not be assessed more than five BsUFA
Program fees for a fiscal year for products identified in each distinct
approved biosimilar biological product application held by that
sponsor.

K. Enhancements to User Fee Revenue Amounts and Adjustments

    FDA and industry agreed that the BsUFA II user fee revenue amounts
and fee amounts should be independent of PDUFA and based on BsUFA
program costs. FDA proposes to establish fees to generate a total of
$45 million in user fee revenue for FY 2018. However, FDA also proposes
that it can adjust this amount when setting the user fee amounts
published in the FY 2018 Federal Register notice to reflect an updated
assessment of the BsUFA workload, with the limitation that this
adjustment cannot increase user fee revenue by more than $9 million
(i.e. relative to the $45 million specified for FY 2018 user fee
revenue). To enhance the predictability of user fee amounts, FDA
proposes that the amount for each BsUFA fee cannot increase more than
25 percent from the respective FY2018 fee amount until the capacity
planning adjustment is effective and that FDA can otherwise modify the
amount of the user fee revenue generated from each fee type each fiscal
year. FDA proposes to adjust the annual user fee revenue amount for
inflation, to develop a robust methodology for adjusting fees based on
the capacity needs of the program, and to introduce an annual operating
reserve adjustment to provide for adequate carryover resources.

IV. Purpose and Scope of the Meeting

    If you wish to attend this meeting, visit http://bsufapublicmeeting.eventbrite.com. Please register by October 19, 2016.
If you are unable to attend the meeting in person, you can register to
view a live Webcast of the meeting. You will be asked to indicate in
your registration if you plan to attend in person or via the Webcast.
Seating will be limited, so early registration is recommended.
Registration is free and will be on a first-come, first-served basis.
However, FDA may limit the number of participants from each
organization based on space limitations. Registrants will receive
confirmation once they have been accepted. Onsite registration on the
day of the meeting will be based on space availability. If you need
special accommodations because of a disability, please contact Amanda
Roache (see FOR FURTHER INFORMATION CONTACT) at least 7 days before the
meeting.
    The meeting will include a presentation by FDA and a series of
invited panels representing different stakeholder groups identified in
the statute (such as patient advocacy groups, consumer advocacy groups,
health professionals, and regulated industry). We will also provide an
opportunity for other organizations and individuals to make
presentations at the meeting or to submit written comments to the
docket before the meeting.
    FDA will also hold an open public comment period at the meeting to
give the public an opportunity to present their comments. Registration
for open public comment will occur at the registration desk on the day
of the meeting and workshop on a first-come, first-served basis.
    Transcripts: As soon as a transcript is available, FDA will post it
at http://www.fda.gov/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/ucm461774.htm.

    Dated: September 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22442 Filed 9-16-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 74 (Tuesday, April 18, 2023)]
[Rules and Regulations]
[Pages 23564-23565]
[FR Doc No: 2023-07888]

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

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2023-0061; Airspace Docket No. 22-ASO-10]
RIN 2120-AA66

Amendment and Revocation of Air Traffic Service (ATS) Routes in
the Eastern United States

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action amends Very High Frequency (VHF) Omnidirectional
Range (VOR) Federal Airways V-51, V-115, V-243, V-267, V-311, V-333,
and V-415; and removes V-463 in support of the FAA's VOR Minimum
Operational Network (MON) Program.

DATES: Effective date 0901 UTC, June 15, 2023. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order JO 7400.11
and publication of conforming amendments.

ADDRESSES: A copy of the Notice of Proposed Rulemaking (NPRM), all
comments received, this final rule, and all background material may be
viewed online at www.regulations.gov using the FAA Docket number.
Electronic retrieval help and guidelines are available on the website.
It is available 24 hours each day, 365 days each year.
    FAA Order JO 7400.11G, Airspace Designations and Reporting Points,
and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. You may also contact the Rules and
Regulations Group, Federal Aviation Administration, 800 Independence
Avenue SW, Washington, DC 20591; telephone:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Paul Gallant, Rules and Regulations
Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it modifies the route structure as necessary to preserve
the safe and efficient flow of air traffic within the National Airspace
System (NAS).

History

    The FAA published a notice of proposed rulemaking for Docket No.
FAA-2023-0061 in the Federal Register (88 FR 7897; February 7, 2023),
amending seven, and revoking one, VOR Federal airways in the eastern
United States. Interested parties were invited to participate in this
rulemaking effort by submitting written comments on the proposal. One
comment was received.
    An anonymous commenter wrote expressing strong support of the push
for satellite navigation, but stated they did not agree with the
removal of victor airways in the Chicago area. The only airway in this
rule that approaches the Chicago area is V-51 which ends at Chicago
Heights, IL. That segment of V-51 is not being removed, and it remains
available for navigation.

Incorporation by Reference

    Domestic VOR Federal airways are published in paragraph 6010(a) of
FAA Order JO 7400.11, Airspace Designations and Reporting Points, which
is incorporated by reference in 14 CFR 71.1 on an annual basis. This
document amends the current version of that order, FAA Order JO
7400.11G, dated August 19, 2022 and effective September 15, 2022. FAA
Order JO 7400.11G is publicly available as listed in the ADDRESSES
section of this document. These amendments will be published in the
next update to FAA Order JO 7400.11.
    FAA Order JO 7400.11G lists Class A, B, C, D, and E airspace areas,
air traffic service routes, and reporting points.

The Rule

    This action amends 14 CFR part 71 by modifying VOR Federal Airways
V-51, V-115, V-243, V-267, V-311, V-333, and V-415; and revoking V-463
in support of the FAA's VOR MON Program. This program aims to improve
the efficiency of the NAS by transitioning from ground-based navigation
systems to satellite based navigation. The changes are described as
follows:
    V-51: V-51 consists of two parts: From Pahokee, FL to Louisville,
KY; and from Shelbyville, IN, to Chicago Heights, IL. This action
removes Alma, GA; Athens, GA; and Harris, GA, from the route. As a
result, V-51 consists of three parts: From Pahokee, FL, to Craig, FL;
From Hinch Mountain, TN, to Louisville, KY; and From Shelbyville, TN to
Chicago Heights, IL.
    V-115: V-115 consists of two parts: From Crestview, FL, to
Volunteer, TN; and from Charleston, WV, to Parkersburg, WV. This action
removes the segment from the BOAZE, AL, Fix to the Choo Choo, TN (GQO),
VOR with Tactical Air Navigational System (VORTAC), to the DUBBS, TN,
Fix, which is dependent on the Choo Choo, TN, VORTAC. As amended, V-115
extends, in three parts: From Crestview, FL, to the intersection of the
of the Vulcan, AL 048[deg](T)/046[deg](M) and the Gadsden, AL
333[deg](T)/331[deg](M) radials (the charted BOAZE, AL) Fix; From the
Intersection of the Hinch Mountain, TN 160[deg](T)/162[deg](M) and the
Volunteer, TN 228[deg](T)/231[deg](M) radials to Volunteer; and From
Charleston, WV, to Parkersburg, WV.
    V-243: V-243 extends from Craig, FL, to Choo Choo, TN. This action
removes the segment from the intersection of the LaGrange, GA 342[deg]
and the Choo Choo, TN 189[deg] radials (the charted HEFIN, AL, Fix) to
Choo Choo due to the planned

decommissioning of the Choo Choo, TN (GQO), VORTAC. The HEFIN, AL, Fix
is redefined by replacing the Choo Choo radial with the Gadsden, AL,
Non-Directional Beacon/Distance Measuring Equipment (NDB/DME)
124[deg](T)/122[deg](M) radial. Because this is a new radial, both True
and Magnetic values were cited in the NPRM. As amended, V-243 extends
from Craig, FL, to the intersection of the LaGrange, GA 342[deg] and
the Gadsden, AL, 124[deg](T)/122[deg](M) radials (the HEFIN, AL, Fix).
    V-267: V-267 extends from Dolphin, FL, to Volunteer, TN. This
action removes the segments from Dolphin, FL, to Pahokee, FL. In
addition, the Harris, GA (HRS), VORTAC and the Volunteer, TN (VXV),
VORTAC are removed from the route. As amended, V-267 extends from
Orlando, FL, to the charted CORCE, GA, Fix. The CORCE, GA, Fix is
currently defined in the V-267 description as the intersection of the
Athens, GA, 340[deg] and the Harris, GA, 148[deg] radials. Due to the
removal of the Harris, GA (HRS), VORTAC, the Harris radial is replaced
in the description by the Rome, GA 077[deg](T)/076[deg](M) radial.
    V-311: V-311 extends from Hinch Mountain, TN, to Charleston, SC.
This action removes the segments from Electric City, SC, to Charleston,
SC. As amended, V-311 extends from Hinch Mountain, TN, to Electric
City, SC.
    V-333: V-333 extends from the intersection of the Rome, GA 133[deg]
and the Gadsden, AL 091[deg] radials to Lexington, KY. The action
removes the Choo Choo, TN (GQO), VORTAC from the route. As amended, V-
333 consists of two parts: From the intersection of the Rome, GA, and
Gadsden, AL, radials identified in the previous sentence to Rome, GA;
and From Hinch, Mountain, TN, to Lexington, KY.
    V-415: V-415 extends from Montgomery, AL, to the intersection of
the Spartanburg, SC, 101[deg] and the Charlotte, NC, 229[deg] radials.
This action removes the segments from the HEFIN, AL, Fix, to the NELLO,
GA, Fix. As amended, V-415 consists of two parts: From Montgomery, AL,
to the intersection of the Montgomery 029[deg](T)/026[deg](M) and the
Gadsden, AL, 124[deg](T)/122[deg](M) radials; and From the intersection
of the Rome, GA, 060[deg] and the Foothills, SC, 258[deg] radials, to
the intersection of the Spartanburg, SC, 101[deg] and the Charlotte,
NC, 229[deg] radials.
    V-463: V-463 is a 49 nautical mile long route that extends from the
intersection of the Harris, GA, 179[deg] and the Foothills, SC,
222[deg] radials, to Harris, GA. This action removes the entire route
to support the scheduled decommissioning of the Harris, GA (HRS),
VORTAC.
    Full descriptions of the above amended routes are listed in the
amendments to part 71 set forth below. Where new radials are used in a
route description, the preamble includes both True and Magnetic
degrees. However, only True degrees are stated in the regulatory text.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under
Department of Transportation (DOT) Regulatory Policies and Procedures
(44 FR 11034; February 26, 1979); and (3) does not warrant preparation
of a regulatory evaluation as the anticipated impact is so minimal.
Since this is a routine matter that only affects air traffic procedures
and air navigation, it is certified that this rule, when promulgated,
does not have a significant economic impact on a substantial number of
small entities under the criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5.a., and 5-6.5.b. This airspace action is
not expected to cause any potentially significant environmental
impacts, and no extraordinary circumstances exist that warrant
preparation of an environmental assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11G Airspace Designations and Reporting Points, dated August 19,
2022, and effective September 15, 2022, is amended as follows:

Paragraph 6010(a) Domestic VOR Federal Airways.

* * * * *

V-51 [Amended]

    From Pahokee, FL; INT Pahokee 010[deg]and Treasure, FL, 193[deg]
radials; Treasure; INT Treasure 330[deg] and Ormond Beach, FL,
183[deg] radials; Ormond Beach; to Craig, FL. From Hinch Mountain,
TN; Livingston, TN; to Louisville, KY. From Shelbyville, IN; INT
Shelbyville 313[deg] and Boiler, IN, 136[deg] radials; Boiler; to
Chicago Heights, IL.
* * * * *

V-115 [Amended]

    From Crestview, FL; INT Crestview 001[deg] and Montgomery, AL,
204[deg] radials; Montgomery; INT Montgomery 323[deg] and Vulcan,
AL, 177[deg] radials; Vulcan; to INT Vulcan 048[deg] and Gadsden, AL
333[deg] radials. From INT Hinch Mountain, TN, 160[deg] and
Volunteer, TN, 228[deg] radials; to Volunteer. From Charleston, WV;
to Parkersburg, WV.
* * * * *

V-243 [Amended]

    From Craig, FL; Waycross, GA; Vienna, GA; LaGrange, GA; to INT
LaGrange 342[deg] and Gadsden, AL, 124[deg] radials.
* * * * *

V-267 [Amended]

    From Orlando, FL; Craig, FL; Dublin, GA; Athens, GA; to INT
Athens 340[deg] and Rome, GA, 077[deg] radials.
* * * * *

V-311 [Amended]

    From Hinch Mountain, TN; INT Hinch Mountain 160[deg] and
Electric City, SC, 274[deg] radials; to Electric City.
* * * * *

V-333 [Amended]

    From INT Rome, GA, 133[deg] and Gadsden, AL, 091[deg] radials to
Rome. From Hinch Mountain, TN; to Lexington, KY.
* * * * *

V-415 [Amended]

    From Montgomery, AL, to INT Montgomery 029[deg]and Gadsden, AL,
124[deg] radials. From INT Rome 060[deg] and Foothills, SC, 258[deg]
radials; Foothills; Spartanburg, SC; to INT Spartanburg 101[deg] and
Charlotte, NC, 229[deg] radials.
* * * * *

V-463 [Removed]

* * * * *

    Issued in Washington, DC, on April 10, 2023.
Brian Konie,
Acting Manager, Airspace Rules and Regulations.
[FR Doc. 2023-07888 Filed 4-17-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 54 (Tuesday, March 20, 2012)]
[Rules and Regulations]
[Pages 16155-16157]
[FR Doc No: 2012-6447]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0191; Directorate Identifier 2012-NM-035-AD;
Amendment 39-16980; AD 2012-05-08]
RIN 2120-AA64

Airworthiness Directives; Empresa Brasileira de Aeronautica S.A.
(EMBRAER) Airplanes

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

ACTION: Final rule; request for comments.

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SUMMARY: We are adopting a new airworthiness directive (AD) for all
Empresa Brasileira de Aeronautica S.A. (EMBRAER) Model ERJ 170
airplanes. This AD requires repetitive inspections for fuel leakage and
cracks on the wing spar II, close to the rib 10 area, and repair if
necessary. This AD was prompted by reports of fuel seepage at the left-
hand wing, close to the rib 10 area in two airplanes. We are issuing
this AD to detect and correct cracking on the wing spar II, which could
result in a fuel leak, consequent reduced structural integrity of the
airplane, and possible fire.

DATES: This AD becomes effective April 4, 2012.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of April 4,
2012.
    We must receive comments on this AD by May 4, 2012.

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

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
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 Operations office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Cindy Ashforth, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone 425-227-
2768; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    The Ag[ecirc]ncia Nacional de Avia[ccedil][atilde]o Civil (ANAC),
which is the aviation authority for Brazil, has issued Brazilian
Airworthiness Directive 2012-02-01, dated February 22, 2012 (referred
to after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:

    It has been found cases of fuel seepage at the Left Hand (LH)
wing and close to the Rib 10 area in two different airplanes.
Further investigation revealed that the seepage was caused by a
crack at the LH wing spar II close to the Rib 10. The ANAC is
issuing this AD to detect and correct cracking in the wing spar II,
which could result in a fuel leak and reduced structural integrity
of the airplane.
* * * * *
    This AD requires repetitive general visual inspections for fuel
leakage on the wing spar II, close to the rib 10 area; repetitive
detailed inspections for cracks on the wing spar II, spar cap third,
and main box lower skins of the wings, close to the rib 10 area; an
eddy current inspection for cracks on the wing spar II if necessary;
and repair if necessary. You may obtain further information by
examining the MCAI in the AD docket.

Relevant Service Information

    EMBRAER has issued Alert Service Bulletin 170-57-A053, dated
February 13, 2012. The actions described in this service information
are intended to correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are issuing this AD because we
evaluated all pertinent information and determined the unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Interim Action

    This AD is considered interim action to address the unsafe
condition. If final action is later identified, we might consider
further rulemaking then.

Differences Between the AD and the MCAI or Service Information

    The MCAI requires actions only for airplanes that have exceeded
12,000 total flight cycles, but the requirements of this (FAA) AD apply
to all Model 170 airplanes.

    For airplanes with fuel leakage but no crack, this AD, in paragraph
(j)(2), requires repeating the general visual and detailed inspections.
The MCAI does not require that this inspection be repeated under those
conditions.
    We have coordinated these differences with ANAC.

FAA's Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD. The FAA has found that the risk to the flying public justifies
waiving notice and comment prior to adoption of this rule because of
fuel leaks caused by spar cracks, which could result in reduced
structural integrity of the wing, and possible fire. Therefore, we
determined that notice and opportunity for public comment before
issuing this AD are impracticable and that good cause exists for making
this amendment effective in fewer than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include ``Docket No. FAA-2012-0191; Directorate
Identifier 2012-NM-035-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this AD. We will consider all
comments received by the closing date and may amend this AD because of
those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this 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.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

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 AD:

2012-05-08 Empresa Brasileira de Aeronautica S.A. (EMBRAER):
Amendment 39-16980. Docket No. FAA-2012-0191; Directorate Identifier
2012-NM-035-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective April 4,
2012.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Empresa Brasileira de Aeronautica S.A.
(EMBRAER) Model ERJ 170-100 LR, -100 STD, -100 SE., and -100 SU
airplanes; and Model ERJ 170-200 LR, -200 SU, and -200 STD
airplanes; certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 57: Wings.

(e) Reason

    This AD was prompted by reports of fuel seepage at the left-hand
wing, close to the rib 10 area in two airplanes. We are issuing this
AD to detect and correct cracking on the wing spar II, which could
result in a fuel leak, consequent reduced structural integrity of
the airplane, and possible fire.

(f) Compliance

    You are responsible for having the actions required by this AD
performed within the compliance times specified, unless the actions
have already been done.

(g) General Visual Inspection for Fuel Leakage

    At the applicable time specified in paragraph (g)(1), (g)(2), or
(g)(3) of this AD: Do a general visual inspection for fuel leakage
on the wings, close to the rib 10 area, while both tanks are fully
fueled, in accordance with Part I of the Accomplishment Instructions
of EMBRAER Alert Service Bulletin 170-57-A053, dated February 13,
2012.

    Note 1 to paragraph (g) of this AD: Guidance on performing the
inspection for fuel leakage can be found in Task 28-11-00-790-801-A,
Wing Tank--Fueled Tank Leakage Check, of the EMBRAER 170/175
Aircraft Maintenance Manual.

    (1) For airplanes that have accumulated 11,999 or fewer total
flight cycles as of the effective date of this AD: Inspect before
the accumulation of 12,000 total flight cycles, or within 150 flight
cycles after the effective date of this AD, whichever occurs later.
    (2) For airplanes that have accumulated more than 11,999 total
flight cycles but fewer than 13,926 total flight cycles as of the
effective date of this AD: Inspect within 150 flight cycles after
the effective date of this AD.
    (3) For airplanes that have accumulated more than 13,925 total
flight cycles as of the effective date of this AD: Inspect before
the accumulation of 14,075 total flight cycles, or within 75 flight
cycles after the effective date of this AD, whichever occurs later.

(h) Detailed Inspection for Cracks (Leakage Found)

    If any sign of fuel leakage is found during any inspection
required by paragraph (g) of this AD, before further flight, do a
detailed inspection for cracks on spar II, spar cap third, and main
box lower skin of the wings, close to the rib 10, in accordance with
Part II or Part III, as applicable, of the Accomplishment
Instructions of EMBRAER Alert Service Bulletin 170-57-A053, dated
February 13, 2012. Repeat the inspection thereafter at intervals not
to exceed 50 flight

cycles until accomplishment of the requirements of paragraph (j) of
this AD.

(i) Detailed Inspection for Cracks (No Leakage Found)

    If no sign of fuel leakage is found during the most recent
inspection required by paragraph (g) of this AD, within 450 flight
cycles after accomplishing the inspection, repeat the general visual
inspection required by paragraph (g) of this AD and do a detailed
inspection for cracks on spar II, spar cap third, and main box lower
skin of the wings, close to the rib 10, in accordance with Part II
and Part III of the Accomplishment Instructions of EMBRAER Alert
Service Bulletin 170-57-A053, dated February 13, 2012. Repeat both
inspections thereafter at intervals not to exceed 450 flight cycles.

(j) Special Detailed Inspection (Leakage Found)

    If any fuel leakage is found during any inspection required by
paragraph (g) or (i) of this AD: Within 150 flight cycles after the
most recent inspection, do an eddy current special detailed
inspection for cracks on spar II of the wings, and a defueled tank
leak check for fuel leakage, in accordance with Part IV and Part V,
as applicable, of the Accomplishment Instructions of EMBRAER Alert
Service Bulletin 170-57-A053, dated February 13, 2012.
    (1) If any crack is found: Do the actions specified in paragraph
(k) of this AD.
    (2) If no crack is found: Repeat the general visual inspection
specified in paragraph (g) of this AD and the detailed inspection
specified in paragraph (i) of this AD at intervals not to exceed 450
flight cycles.

(k) Repair

    If any cracking or fuel leakage is found during any inspection
or check required by this AD: Before further flight, repair using a
method approved by either the Manager, International Branch, ANM-
116, Transport Airplane Directorate, FAA; or the Ag[ecirc]ncia
Nacional de Avia[ccedil][atilde]o Civil (ANAC) (or its delegated
agent). Repair of any crack terminates the repetitive inspection
requirements required by this AD for that side of the wing.

    Note 2 to paragraph (k) of this AD: Guidance on the
classification of ``fuel leakage'' and the disposition of fuel leaks
can be found in Task 28-11-00-790-801-A, Wing Tank--Fueled Tank
Leakage Check, of the EMBRAER 170/175 Aircraft Maintenance Manual.

(l) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, 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 International
Branch, ANM-116, send it to ATTN: Cindy Ashforth, Aerospace
Engineer, International Branch, ANM-116, Transport Airplane
Directorate, FAA, 1601 Lind Avenue SW., Renton, Washington 98057-
3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information may be
emailed to<EMAIL_ADDRESS>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. The
AMOC approval letter must specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(m) Special Flight Permits

    Special flight permits, as described in Section 21.197 and
Section 21.199 of the Federal Aviation Regulations (14 CFR 21.197
and 21.199), are not allowed.

(n) Related Information

    Refer to MCAI Brazilian Airworthiness Directive 2012-02-01,
dated February 22, 2012; and EMBRAER Alert Service Bulletin 170-57-
A053, dated February 13, 2012; for related information.

(o) Material Incorporated by Reference

    (1) You must use the following service information to do the
actions required by this AD, unless the AD specifies otherwise. The
Director of the Federal Register approved the incorporation by
reference (IBR) of the following service information under 5 U.S.C.
552(a) and 1 CFR part 51:
    (i) Embraer Alert Service Bulletin 170-57-A053, dated February
13, 2012.
    (2) For service information identified in this AD, contact
Empresa Brasileira de Aeronautica S.A. (EMBRAER), Technical
Publications Section (PC 060), Av. Brigadeiro Faria Lima, 2170-
Putim-12227-901 S[atilde]o Jose dos Campos--SP--BRASIL; telephone
+55 12 3927-5852 or +55 12 3309-0732; fax +55 12 3927-7546; email
<EMAIL_ADDRESS>Internet http://www.flyembraer.com.
    (3) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.
    (4) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at an NARA facility, call<PHONE_NUMBER>, or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

    Issued in Renton, Washington, on March 7, 2012.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-6447 Filed 3-19-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 46 (Wednesday, March 9, 2011)]
[Notices]
[Page 12960]
[FR Doc No: 2011-5069]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2011-0001; FRL-8866-3]

SFIREG Environmental Quality Issues Working Committee; Notice of
Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Association of American Pesticide Control Officials
(AAPCO)/State FIFRA Issues Research and Evaluation Group (SFIREG),
Environmental Quality Issues (EQI) Working Committee will hold a 2-day
meeting, beginning on April 18, 2011 and ending April 19, 2011. This
notice announces the location and times for the meeting and sets forth
the tentative agenda topics.

DATES: The meeting will be held on Monday, April 18, 2011 from 8:30
a.m. to 5 p.m. and 8:30 a.m. to 12 noon on Tuesday April 19, 2011.
    To request accommodation of a disability, please contact the person
listed under FOR FURTHER INFORMATON CONTACT, preferably at least 10
days prior to the meeting, to give EPA as much time as possible to
process your request.

ADDRESSES: The meeting will be held at EPA. One Potomac Yard (South
Bldg.), 2777 Crystal Dr., Arlington, VA. 1st Floor South Conference
Room.

FOR FURTHER INFORMATION CONTACT: Ron Kendall, Field and External
Affairs Division, (7506P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>or Grier Stayton, SFIREG Executive Secretary, P.O.
Box 466, Milford, DE 19963; telephone number<PHONE_NUMBER>; fax (302)
422-2435; e-mail address: Grier Stayton at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are
interested in SFIREG information exchange relationship with EPA
regarding important issues related to human health, environmental
exposure to pesticides, and insight into EPA's decision-making process.
You are invited and encouraged to attend the meetings and participate
as appropriate. Potentially affected entities may include, but are not
limited to:
    Those persons who are or may be required to conduct testing of
chemical substances under the Federal Food, Drug and Cosmetics Act
(FFDCA), or the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

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

    EPA has established a docket for this action under docket ID number
EPA-HQ-OPP-2011-0001. Publicly available docket materials are available
either in the electronic docket at http://www.regulations.gov, or, if
only available in hard copy, at the Office of Pesticide Programs (OPP)
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The hours of operation of this
Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

II. Tentative Agenda Topics

    Topics to be discussed may include, but are not limited to the
following:
    1. Bed Bugs: Issue Paper; Remediation Overview;
    2. Update: Aquatic Life Benchmarks;
    3. Common Aquatic Life Affects Assessment;
    4. USDA Drinking Water Monitoring;
    5. National Pollution Discharge Elimination System permit: Update,
feedback;
    6. Washington State White Paper on Endangered Species;
    7. Update: Endangered Species, Litigation, Biological Opinions;
    8. Chemigation: Recommendations, Follow-up;
    9. Driftwatch;
    10. National Water Quality Assessment (NAWQA) Briefing.

III. How can I request to participate in this meeting?

    This meeting is open for the public to attend. You may attend the
meeting without further notification.

List of Subjects

    Environmental protection.

    Dated: February 24, 2011.
Robert C. McNally,
Acting Director, Field and External Affairs Division, Office of
Pesticide Programs.
[FR Doc. 2011-5069 Filed 3-8-11; 8:45 am]
BILLING CODE 6560-50-P


Potential Small Entity Representative (SER)

Response to Initial Outreach Document:

Exhaust and Evaporative Emissions Control from Small SI Engines and
Equipment and Marine SI Engines and Vessels

Geoffrey T. Ward, Ph.D.

Engineering Manager

Agri-Industrial Plastics Company

Fairfield, Iowa

July 25, 2006

Executive Summary

Agri-Industrial Plastics Company (AIP) is a small custom blow molder,
who supplies fuel tanks for both the Small SI Engine and Marine SI
Engine markets.  Thus, the areas of concern for AIP are based on the
proposed standard for permeation from fuel tanks.  In response to the
EPA permeation standard for Recreation Vehicles, AIP purchased a
multi-layer fuel tank machine, and as such has good experience regarding
cost and lead time requirements for meeting such a standard.

The primary issue that will affect AIP is the proposed implementation
date of MY2009 for both engine categories.  While the technology exists
to meet this implementation date, the capacity does not.  We would
propose that a date of MY2011 would be a more realistic implementation
date, given an estimated publication date for the finalized rule of the
end of CY2007.

The proposed gap of two years between implementation of general fuel
tanks and rotational molded fuel tanks is considered to be unacceptable
by AIP.  This presents a potential loss of business issue, in that
existing customers using blow molded fuel tanks will most certainly
consider redesigning for rotational molding, simply because of the
benefit of delaying compliance for two years.

The estimated cost of implementation as presented is considered to be
extremely low, even by conservative standards.  Our experience to date
suggests that a typical monolayer fuel tank in these markets, currently
in the $10-$20 price range, will likely increase by about 40-50% when
moving to a multi-layer construction.

Additional details regarding these issues will be provided as responses
to the detailed questions presented in the Outreach Document.

Detailed Responses to Questions for Potential SERs

1A – How useful would each of the small flexibility ideas discussed be
for your business in meeting the applicable standards?

Broadening the definition of engine families for certification

This would be very useful in terms of reducing the number of different
sample fuel tanks required to be provided for certification testing.  We
would propose that for evaporative emission, families could be defined
by the technology used for certification.  For example, all multi-layer
fuel tanks manufactured at a specific supplier for a given OEM would be
considered a family.  Thus, a single tank could be tested, with the
emission level applied across the entire family.  This would minimize
the amount of available production capacity that would be used up to
produce sample tanks for testing.

Minimizing compliance testing requirements

Again, this would be very useful, based on the capacity reasons noted
above.

Design-based certification

This would also be very useful.  While the current Recreational Vehicle
standard allows for design-based certification of steel fuel tanks, the
CARB standard extends this to co-extruded multi-layer plastic fuel
tanks.  Given the extensive use of this proven technology in automobiles
at a much lower evaporative emissions limit, we would suggest that
substantial data exists to justify a design-based standard for this
technology.  This would further decrease the demand against the limited
production capacity that is available.  As an option, an OEM could still
choose to test a fuel tank in the multi-layer family for the potential
purpose of defining a Family Emission Limit to be used in an averaging
calculation with other technology families.

Use of emission credits

This would be extremely useful, in fact almost critical when considering
the options for providing service fuel tanks for obsolete products.  The
low number of service tank requirements makes it impractical to break
into normal production on a limited capacity multi-layer machine to
provide service parts.  The ability to apply credits from active
production years would allow for different options to provide these
service parts at a higher emission limit.

Delay of the implementation date of the standards

This is not only useful, it will be necessary if AIP is to be able to
continue to provide fuel tanks to these markets.  This also extends
beyond AIP, as it is questionable as to whether the necessary capacity
exists anywhere in the industry.  This point will be expanded in the
next question.

Hardship provisions

This is not likely to affect AIP, as this appears to be aimed primarily
to target small OEMs.  We do have some small customers with low EAU
products that we cannot serve with the multi-layer machine.  If these
companies were granted hardship provisions that would enable them to
continue to take monolayer product, this may prevent or delay a loss of
business with these customers.

Limited temporary exemptions for small boat builders

This would not affect AIP.

2A – Can you comment on the length of a potential delay option?

Based on our experience in working to comply with the Recreational
Vehicle standard, it was necessary to order a multi-layer machine in
May, 2004 in order to meet a MY2008 implementation date.  Based on
current orders to meet this standard, as well as the CARB Small SI
Engine standard, the capacity on this machine is full.  There is
currently not enough of this type of machine to meet the full capacity
requirements for these existing standards.  In addition, many of the
machines that are available are too large to produce the smaller fuel
tanks in the Small SI Engine market.

The current lead time for a new machine is at least 12 months for
delivery.  With machine assembly and break-in period, this lead time
increases to nearly 18 months, after which time sample tanks for
certification and qualification will need to be produced.  Given the
testing time, we estimate that a new machine would be ready for
production approximately 2 years after placing the order.

It would not be prudent to order a machine to meet a standard until that
standard is finalized.  With an estimated publication date for the final
rule approaching the end of CY2007, this leads to a production start-up
date at the end of CY2009.  For some models, this would be sufficient to
meet MY2010 production.  However, some OEMs begin their model year much
earlier, thus a practical implementation date would be MY2011 for Small
SI Engine fuel tanks.

Regarding Marine SI fuel tanks, the numbers published in the
supplementary reports show a range of approximately 80,000-90,000 PWC
vehicles sold domestically per year.  Each of the fuel tanks in this
market is currently blow molded.  It would take this entire market worth
of fuel tanks to come close to filling a multi-layer machine, although
there would still be some remaining capacity.  It is not a practical
business case to purchase a dedicated machine of this type in
anticipation of serving an entire market segment.  The timeline given
above would suggest that capacity could be available by MY2011, however
the lack of a business case suggests that it would be risky to assume
that this capacity will be purchased solely for that purpose.  Thus,
machine capacity currently earmarked for other markets will need to be
utilized, or different technologies will likely need to be employed.

Other technologies, such as thermoforming, may be able to assist in the
capacity, however not many of these machines exist, either.  In
addition, this would result in a loss of business for AIP if our current
customers were forced to find an alternate technology.

3A – Do your answers to these questions differ based on the level of
the standard and/or timing of the program implementation date?

They may.  If the standard was relaxed initially with time for
multi-layer capacity to become available, it may be possible to
introduce a different technology, such as fluorination with some level
of confidence.  Even so, the shear numbers of fuel tanks in the Small SI
Engine market may overwhelm the ability of fluorination capacity to
become available by MY2009 production.  Even this may require a delay to
at least MY2010.

4A – Do you have suggestions for other potential small entity
flexibility options, or any additional suggestions on the flexibility
options discussed?

We would strongly endorse an averaging program to allow OEMs to take
advantage of low emissions levels from a strong technology such as
multi-layer construction, and average these results with other tanks
made with a barrier that may not meet the standard.  This would benefit
AIP from the sense that we could continue to provide low EAU tanks for
our existing customers without using up valuable multi-layer machine
capacity that is required to meet their higher volume orders.
Understanding that this averaging approach is included in the
Recreational Vehicle standard, this may already be under consideration
for the proposed standard.

1B – 3B:  Level of Exhaust Standards questions -  Not applicable to
AIP

1C – Can you comment on the evaporative emission standards under
consideration for Small SI engines and equipment or Marine SI engines
and vessels?

From a technology standpoint, the technology certainly exists to meet
this level of standard for currently blow molded tanks.  However, the
primary concern is that the capacity does not exist to fulfill the
entire market, nor will it exist in time to meet an implementation date
of MY2009, as noted above.  While the CARB standard for the Small SI
engines begins in MY2008, many of our customers are not planning on
transitioning their entire fleet of engines to comply with this standard
at that time.  Thus, it is not a matter of recertifying existing barrier
fuel tanks to a different standard.

2C – Specifically, how would this affect your businesses?

Based on our research in response to the Recreational Vehicle standard,
the most reliable and cost effective way to meet this proposed
evaporative standard is to begin supplying multi-layer co-extruded fuel
tanks.  This would require at least one additional multi-layer blow
molding machine at a large capital expense, with a long lead time before
a payback period would begin.  This machine could likely be justified
for the Small SI Engine market, however as noted above, the business
case is much more difficult to justify for the Marine SI market.

For the Marine SI market, the basic options for AIP would be:  a)
Purchase yet another machine, anticipating that enough additional
business from the Recreational Vehicle and/or Small SI Engine markets
would fill the excess capacity, b) Attempt to fit as much of the
existing Marine SI business into the current machine and the potentially
purchased Small SI machine, or c) Inform our existing Marine SI
customers that we will not be able to supply multi-layer tanks for this
market.  The first option comes with a very high financial risk for a
small company.  The second option comes with a risk of overselling the
available capacity or a potential loss of business for the products that
would not fit in the existing capacity.  The last option would result in
a potential loss of business situation, if we could not provide them
with monolayer tanks that were subsequently treated in some manner.
Thus, all likely scenarios resulting from a Marine SI Engine standard
contain a potential level of risk that would normally be considered
unacceptable from a business standpoint.

3C – Would the new standards require changes to your engine,
equipment, vessel, or fuel system components?

As a fuel tank supplier, the direct answer from our perspective is no.
However, it should be noted that for much of the Small SI Engine market,
and possibly all of the PWC market, current fuel tanks are supplied in a
natural resin color to allow for translucency.  Most, if not all, of the
viable barrier solutions for blow molded fuel tanks will result in
opaque fuel tanks, which in many cases will result in the need for some
type of fuel level gauge or sensor.  Many OEMs are either not aware of
this or are fighting it.

1D – What do you estimate would be the per unit variable and/or fixed
costs for your businesses to meet the standards EPA is considering?

Raw material cost increase from a monolayer HDPE resin to a multi-layer
recipe is currently estimated to be in the $0.25 - $0.40 range on a per
pound basis, depending on the HDPE resin price at the time and the
acceptable regrind contribution.  In addition to the base material
price, variable scrap costs may also incur based on the amount of excess
material required as a function of tank design.

Given the above material cost in addition to increased overhead rates
for multi-layer equipment, our experience in the Recreational Vehicle
market suggests a per unit sell price will increase in the range of
40-50% over the cost of an equivalent monolayer fuel tank.  Thus,
current fuel tanks selling in the $10-$20 range will increase to $15-$30
on the average.  This price will increase further if some type of fuel
gauge or sensor will need to be added to the tank design to move from a
natural color to a black multi-layer tank.

In addition to these direct costs, it is important to consider that with
a single machine available to meet all demands, typical lean
manufacturing principles designed to minimize run lengths and increase
inventory turns do not apply very well.  In fact, we anticipate the need
to potentially hold finished inventory for up to several months for low
EAU applications.

Our cost studies conducted when researching 5-15 gallon fuel tanks in
the Recreational Vehicle market showed that the markup for a multi-layer
fuel tank was at the low end when compared to other viable options.  As
some Small SI fuel tanks are smaller than this, other options may become
more cost competitive as the more costly monolayer materials make up
less of the total cost, and the batch process of fluorination can treat
more tanks at the same price.

The cost of a blow mold designed for a multi-layer fuel tank may add up
to a few thousand dollars to add certain recommended design features to
ensure integrity of the fuel tanks made with this process.  In addition,
a common approach for molding fuel tanks is to utilize an injection
molded fill neck and/or other components.  These components are commonly
insert-molded into the blow mold and captured during the molding
process.  Due to differences with the multi-layer extrusion process, for
certain applications it may be necessary to add a secondary welding
operation to the overall process.  The tooling cost for welding these
features can easily reach up to tens of thousands of dollars, depending
on the application and welding approach employed.

In the case of fluorinated fuel tanks, the logistical costs associated
with additional shipping, and multiple handling of the tanks, as well as
the transfer of assembly operations that may otherwise be completed
in-line during the molding cycle have not yet been estimated by AIP.
These costs have been cited by many customers when concluding that the
overall cost of fluorination is not competitive with the multi-layer
option, despite a lower price estimate when only considering the direct
cost of fluorination added to the price of a monolayer tank.

Much of the R&D costs at AIP have already been absorbed during the
process of evaluating different options to meet the Recreational Vehicle
standard.  However, as recent advancements in monolayer barrier
solutions become increasingly viable, additional R&D expenses will be
required to evaluate these options in order to provide the necessary
flexibility to meet the needs of the entire industry.  The level of R&D
costs associated with this is difficult to predict at this time.  In
addition, with the current certification testing requirement in the
proposed standard, the cost to provide each set of sample fuel tanks for
testing can reach up to $5000.

Additional confidential details outlining the potential per unit price
increase are provided in the Appendix of this response report.

2D – If applicable, what types of hardware, capital equipment and/or
operational changes would you potentially require?

The capital cost for a new multi-layer machine of the size required for
much of the Small SI Engine fuel tanks currently produced at AIP is
likely to approach $3 million, including auxiliary equipment to support
the production line.  For a larger machine to support the PWC market,
this would increase to about $4 million.  This capital cost is magnified
when considering the cost of money required to purchase a machine that
would not produce production fuel tanks for up two years after placing
the order.  In addition, it may become necessary to purchase secondary
equipment to support any welding operations that are not currently
performed, as discussed above.

3D – How long would these operational changes take (i.e. from initial
planning to construction and start-up)?

As stated above, we anticipate a lead time to production of up to two
years.  Barring any reason to purchase additional equipment based on
existing demand, this timeline would not begin until the final rule is
published.

4D – How useful would delays for small businesses be and how long
would such delays need to be to be beneficial?

These delays would be very useful, as discussed earlier.

5D – Would a phase-in, perhaps based on percent of total per unit
sales, be helpful?

Yes, extremely helpful.

6D – Based on your experience with earlier EPA standards, does the
expectation of manufacturers to pass on the added costs to consumers
seem reasonable?

Whether it is reasonable or not, this will be a necessary condition for
us to be able to supply fuel tanks.  We simply cannot afford to absorb
these costs.

[The appendix was marked confidential and has been deleted from this
document.  This appendix was titled “Detailed Cost Assumptions.”]