[Federal Register: May 8, 2009 (Volume 74, Number 88)]
[Notices]
[Page 21696-21697]
[DOCID:fr08my09-87]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-E-0048] (formerly Docket No. 2007E-0445)

Determination of Regulatory Review Period for Purposes of Patent
Extension; NEUPRO TRANSDERMAL SYSTEM

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) has determined the
regulatory review period for NEUPRO TRANSDERMAL SYSTEM and is
publishing this notice of that determination as required by law. FDA
has made the determination because of the submission of an application
to the Director of Patents and Trademarks, Department of Commerce, for
the extension of a patent which claims that human drug product.

ADDRESSES:  Submit written comments and petitions to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:  Beverly Friedman, Office of
Regulatory Policy, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 6222, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Public Law 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the human drug product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human drug product
and continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of Patents and
Trademarks may award (for example, half the testing phase must be
subtracted as well as any time that may have occurred before the patent
was issued), FDA's determination of the length of a regulatory review
period for a human drug product will include all of the testing phase
and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA recently approved for marketing the human drug product NEUPRO
TRANSDERMAL SYSTEM (rotigotine). NEUPRO TRANSDERMAL SYSTEM is indicated
for the treatment of the signs and symptoms of early-stage idiopathic
Parkinson's disease. Subsequent to this approval, the Patent and
Trademark Office received a patent term restoration application for
NEUPRO TRANSDERMAL SYSTEM (U.S. Patent No. 6,884,434) from Schwarz
Pharma Limited, and the Patent and Trademark Office requested FDA's
assistance in determining this patent's eligibility for patent term
restoration. In a letter dated April 28, 2008, FDA advised the Patent
and Trademark Office that this human drug product had undergone a
regulatory review period and that the approval of NEUPRO TRANSDERMAL
SYSTEM represented the first permitted commercial marketing or use of
the product. Shortly thereafter, the Patent and Trademark Office
requested that FDA determine the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for
NEUPRO TRANSDERMAL SYSTEM is 4,367 days. Of this time, 3,535 days
occurred during the testing phase of the regulatory review period,
while 832 days occurred during the approval phase. These periods of
time were derived from the following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective:
May 27, 1995. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on May 27,
1995.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the act: January 28,
2005. The applicant claims January 19, 2005, as the date the new drug
application (NDA) for NEUPRO TRANSDERMAL SYSTEM (NDA 21-829) was
initially submitted. However, FDA records indicate that NDA 21-829 was
initially submitted on January 28, 2005, the date of receipt by the
Agency of a resubmission following a refusal to file.
    3. The date the application was approved: May 9, 2007. FDA has
verified the applicant's claim that NDA 21-829 was approved on May 9,
2007.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 744 days of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) written or electronic comments and ask for a redetermination
by July 7, 2009. Furthermore, any interested person may petition FDA
for a determination regarding whether the applicant for extension acted
with due diligence during the regulatory review period by November 4,
2009. To meet its burden, the petition must contain sufficient facts to
merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d
sess., pp. 41-42, 1984.) Petitions should be in the format specified in
21 CFR 10.30.
    Comments and petitions should be submitted to the Division of
Dockets Management. Three copies of any mailed information are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Comments and petitions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: April 6, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E9-10818 Filed 5-7-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 76, Number 154 (Wednesday, August 10, 2011)]
[Notices]
[Pages 49533-49536]
[FR Doc No: 2011-20283]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2011-0114]

Spyker Automobielen B.V.; Receipt of Application for Temporary
Exemption from FMVSS No. 126

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Notice of receipt of petition for a temporary exemption from
Federal Motor Vehicle Safety Standard (FMVSS) No. 126, Electronic
Stability Control Systems.

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SUMMARY: In accordance with the procedures in 49 CFR Part 555, Spyker
Automobielen B.V. (Spyker) has applied for a temporary exemption for
its C line of vehicles from the requirements of FMVSS No. 126, the
standard for electronic stability control systems. The basis of the
application is that compliance would cause substantial economic
hardship to a manufacturer that has tried in good faith to comply with
the standard.
    NHTSA is publishing this notice of receipt of the application in
accordance with the requirements of 49 U.S.C. 30113(b)(2), and has made
no judgment on the merits of the application.

DATES: You should submit your comments not later than August 25, 2011.

FOR FURTHER INFORMATION CONTACT: Thomas Healy, Office of the Chief
Counsel, NCC-112, National Highway Traffic Safety Administration, 1200
New Jersey Avenue, SE., West Building 4th Floor, Room W41-212,
Washington, DC 20590. Telephone:<PHONE_NUMBER>; Fax:<PHONE_NUMBER>.
    Comments: We invite you to submit comments on the application
described above. You may submit comments identified by the docket
number at the heading of this notice by any of the following methods:
     Web Site: http://www.regulations.gov. Follow the
instructions for submitting comments on the electronic docket site by
clicking on ``Help and Information'' or ``Help/Info.''
     Fax: 1-202-493-2251.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, Room W12-140, 1200 New Jersey Avenue, SE.,
Washington, DC 20590.
     Hand Delivery: 1200 New Jersey Avenue, SE., West Building
Ground Floor, Room W12-140, Washington, DC, between 9 am and 5 pm,
Monday through Friday, except Federal holidays.

     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
    Instructions: All submissions must include the agency name and
docket number. Note that all comments received will be posted without
change to http://www.regulations.gov, including any personal
information provided. Please see the Privacy Act discussion below. We
will consider all comments received before the close of business on the
comment closing date indicated above. To the extent possible, we will
also consider comments filed after the closing date.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov at any time or to
1200 New Jersey Avenue, SE., West Building Ground Floor, Room W12-140,
Washington, DC 20590, between 9 am and 5 pm, Monday through Friday,
except Federal holidays. Telephone:<PHONE_NUMBER>.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit
http://www.dot.gov/privacy.html.
    Confidential Business Information: If you wish to submit any
information under a claim of confidentiality, you should submit three
copies of your complete submission, including the information you claim
to be confidential business information, to the Chief Counsel, NHTSA,
at the address given under FOR FURTHER INFORMATION CONTACT. In
addition, you should submit two copies, from which you have deleted the
claimed confidential business information, to Docket Management at the
address given above. When you send a comment containing information
claimed to be confidential business information, you should include a
cover letter setting forth the information specified in our
confidential business information regulation (49 CFR Part 512).

SUPPLEMENTARY INFORMATION:

I. Overview of Petition for Economic Hardship Exemption

    In accordance with 49 U.S.C. 30113 and the procedures in 49 CFR
Part 555, Temporary Exemption from Motor Vehicle Safety and Bumper
Standards, Spyker has submitted a petition (dated November 19, 2010)
asking the agency for a temporary exemption from the requirements of
FMVSS No. 126, Electronic Stability Control Systems, for its C line of
vehicles. The basis for the application is that compliance would cause
substantial economic hardship to a manufacturer that has tried in good
faith to comply with the standard.
    NHTSA established part 555 to implement the statutory provisions
concerning temporary exemptions. Vehicle manufacturers may apply for
temporary exemptions from Federal motor vehicle safety standards on
several bases, one of which is that compliance would cause substantial
economic hardship to a manufacturer that has tried in good faith to
comply with the standard.
    A manufacturer is eligible to apply for a hardship exemption if its
total motor vehicle production in its most recent year of production
did not exceed 10,000 vehicles, as determined by the NHTSA
Administrator (49 U.S.C. 30113).
    A petitioner must provide specified information in submitting a
petition for exemption. Foremost among these requirements are that the
petitioner must set forth the basis of the application under 49 CFR
555.6, and the reasons why the exemption would be in the public
interest and, as applicable, consistent with the objectives of the
National Traffic and Motor Vehicle Safety Act (Safety Act), 49 U.S.C.
Chapter 301. In a petition for economic hardship, the petitioner must
explain in detail ``how compliance or failure to obtain an exemption
would cause substantial economic hardship.'' 49 CFR 555.6(a)(1). The
petition must also describe the efforts of the petitioner to comply
with the standard at issue.
    The agency closely examines and considers the information provided
by manufacturers in support of these factors, and, in addition,
pursuant to 49 U.S.C. 30113(b)(3)(A), determines whether an exemption
is in the public interest and consistent with the Safety Act. Spyker
requests a temporary exemption until September 1, 2013. Copies of
Spyker's petition \1\ are available for review and have been placed in
the docket for this notice.
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    \1\ Spyker has requested confidential treatment under 49 CFR
Part 512 for certain business and financial information submitted as
part of its petition for temporary exemption. Accordingly, the
information placed in the docket does not contain the information
that is the subject of this request.
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II. Electronic Stability Control Systems Requirements

    NHTSA published a final rule requiring that vehicles with a gross
vehicle weight rating of 4,536 kilograms (kg) (10,000 pounds) and less
be equipped with electronic stability control (ESC) in April of 2007.
The rule seeks to reduce the risk of rollover crashes by assisting the
driver in maintaining control of his or her vehicle in situations in
which the vehicle begins to lose directional stability at the rear
wheels (spin out) or directional control at the front wheels (plow
out).
    Preventing single-vehicle loss-of control crashes is the most
effective way to reduce deaths resulting from rollover crashes. NHTSA's
crash data study shows that ESC systems reduce fatal single-vehicle
crashes of passenger cars by 36 percent and fatal single-vehicle
crashes of LTVs (light trucks and vans, including pickup trucks, SUVs,
minivans, and full-size vans) by 63 percent.\2\ The agency further
estimates that ESC has the potential to prevent 70 percent of the fatal
passenger car rollovers and 88 percent of the fatal LTV rollovers that
would otherwise occur in single-vehicle crashes.\3\
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    \2\ Dang, J., Statistical Analysis of the Effectiveness of
Electronic Stability Control (ESC) Systems--Final Report, DOT HS 810
794, U.S. Department of Transportation, Washington, DC (July 2007).
Available at Docket No. NHTSA-2007-28629, item 2.
    \3\ Id.
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    ESC utilizes automatic computer-controlled braking of the
individual wheels of the vehicle in order to assist the driver in
maintaining vehicle control. An anti-lock brake system (ABS) is a
prerequisite for an ESC system because ESC uses many of the same
components as ABS. Thus, the cost of complying with FMVSS No. 126 is
less for vehicle models already equipped with ABS. The ESC requirement
becomes effective as to Spyker September 1, 2011.

III. Spyker's Petition

    Spyker bases its request for exemption on the argument that
compliance with FMVSS No. 126 ``would cause substantial economic
hardship to a manufacturer that has tried to comply with the standard
in good faith.'' 49 U.S.C. 30113(b)(3)(B)(i). Spyker requests that the
exemption period begin on September 1, 2011 and extend 24 months until
September 1, 2013.

A. Eligibility

    A manufacturer is eligible to apply for a hardship exemption if its
total motor vehicle production in its most recent year of production
did not exceed

10,000 vehicles, as determined by the NHTSA Administrator (49 U.S.C.
30113(d)). In determining whether a manufacturer of a vehicle meets
that criterion, NHTSA considers whether a second vehicle manufacturer
also might be deemed the manufacturer of that vehicle. The statutory
provisions governing motor vehicle safety (49 U.S.C. Chapter 301) do
not state that a manufacturer has substantial responsibility as
manufacturer of a vehicle simply because it owns or controls a second
manufacturer that assembled that vehicle. However, the agency considers
the statutory definition of ``manufacturer'' (49 U.S.C. 30102) to be
sufficiently broad to include sponsors, depending on the circumstances.
NHTSA has stated that a manufacturer may be deemed to be a sponsor and
thus a manufacturer of a vehicle assembled by a second manufacturer if
the first manufacturer had a substantial role in the development and
manufacturing process of that vehicle.
    Spyker Automobielen B.V. is a small volume manufacturer of luxury
sports cars. Since 2005, Spyker Automobielen B.V. has manufactured less
than 100 vehicles annually worldwide, and the company projects that it
will manufacture 103 vehicles in 2011. However, the petition states
that Spyker Automobielen B.V. is a wholly owned subsidiary of Spyker
Cars NV, a publicly traded Netherlands corporation. Spyker Cars NV also
owns Saab Automobile AG, a large Swedish car manufacturer. Spyker
asserts that Spyker Automobielen B.V. is financially and operationally
independent from Saab Automobile AG and that, based on past NHTSA
determinations regarding the issue of sponsorship, Spyker Automobielen
B.V. remains eligible for a temporary exemption based on economic
hardship.
    Since filing its petition, Spyker has informed the agency that
Spyker Cars NV plans to sell Spyker Automobielen B.V. to CPP Global
Holdings, a private holding company in the United Kingdom. Because of
the relationship between Spyker Automobielen B.V., Spyker Cars NV, and
Saab Automobile AG, and, in light of the plans to sell Spyker
Automobielen B.V. to CPP Global Holdings, NHTSA will closely examine
whether Spyker is eligible for a financial hardship exemption. NHTSA
specifically requests comments on the issue of Spyker's eligibility.

B. Substantial Economic Hardship

    Spyker states that it is suffering financial hardship because of
lower than anticipated sales volumes due to the recent world wide
economic recession. Specifically, Spyker suffered a net operating loss
of approximately 132,000,000 Euros ($171,600,000) \4\ from 2004 to
2009. Spyker projected a further loss in 2010 of 12,000,000 Euros
($15,600,000). Based on 2011-2013 financial projections, Spyker
estimates that, if its petition were denied, it would bear a loss over
three years of more than 41,000,000 Euros ($53,300,000) as opposed to
an 8,000,000 Euros ($10,400,000) loss should the petition be granted,
representing a difference of 33,000,000 Euros ($42,900,000). Spyker
also states that the loss of sales in the U.S. that would result if the
exemption petition were denied could not be made up in the rest of the
world because the U.S. is the largest and most important market for the
vehicle. Spyker argues that such consequences demonstrate ``substantial
economic hardship'' within the meaning of 49 U.S.C. 30113(b)(3)(B)(i).
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    \4\ All dollar values are based on an exchange rate of 1 Euro =
$1.30.
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C. Good Faith Efforts To Comply

    Spyker states that in 2008 it began working with Bosch Engineering,
GmbH (Bosch) to develop an ESC system for the Spyker C line and D line
models. Spyker states that in order to develop an ESC system, it first
had to develop a new ABS system. In an effort to achieve compliance
with FMVSS No. 126, Spyker has developed a vehicle to test its new ABS
system and created a new ABS software package. Under its original
testing schedule, Spyker planned to complete development of the ABS/ESC
system before the September 1, 2011 compliance date of FMVSS No. 126.
However, due to the drop in sales resulting from the global economic
recession, Spyker did not have funds available to continue ESC
development as planned.
    Spyker states that its inability to commence testing in 2010
delayed its development schedule for ESC because it will have to wait
an additional year for winter conditions necessary to test ESC.\5\
Spyker states that it has spent 781,000 Euros ($1,015,300) developing
an ESC system thus far. Spyker states that it will likely not have
sufficient funds to continue work on its ESC system until the end of
2011. Spyker states that it will be able to have a test vehicle
completed by the end of 2012 and an ESC system fully developed by 2013.
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    \5\ Spyker states that it does not have the available financial
resources to travel to other parts of the world to conduct winter
testing and thus must wait for winter in Europe to complete ESC
testing.
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D. Public Interest

    The petitioner put forth several arguments in favor of a finding
that the requested exemption is consistent with the public interest and
would not have a significant adverse impact on safety. Specifically:
    1. Spyker states that the exempted vehicles will comply with all
FMVSSs other than the advanced airbag requirements of FMVSS No. 208,
Occupant crash protection, and the standard that is the subject of this
exemption request.\6\
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    \6\ Spyker also submitted a request for an extension of its
previously granted exemption from compliance with the advanced air
bag requirements of FMVSS No. 208 on October 13, 2010.
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    2. The petitioner states that an exemption will benefit U.S.
employment and U.S. companies because Spyker vehicles are distributed
by a U.S. company, Spyker of North America, and are sold and serviced
in the U.S. through a network of 18 dealers. Spyker argues that the
denial of this exemption will negatively impact these companies.
    3. Spyker argues that if the exemption is not granted, U.S.
consumer choice would be harmed and that the agency has long maintained
that the Safety Act seeks, if possible, to avoid limiting consumer
choice.
    4. The petitioner argues that given their exotic design and high-
performance nature, the C line vehicles are not expected to be used
extensively, nor are they expected to carry children with any
significant frequency.

IV. Issuance of Notice of Final Action

    Upon receiving a petition, NHTSA conducts an initial review of the
petition with respect to whether the petition is complete and whether
the petitioner appears to be eligible to apply for the requested
petition. The agency has tentatively concluded that the petition is
complete and that the petitioner is eligible to apply for the requested
exemption. The agency has not made any judgment on the merits of the
application and is placing a non-confidential copy of the petition in
the docket.
    We are providing a 15-day comment period in an effort to provide a
decision with respect to the petition before the September 1, 2011
compliance date for FMVSS No. 126. After considering public comments
and other available information, we will publish a notice of final
action on the application in the Federal Register.

    Issued on: August 5, 2011.
Christopher J. Bonanti,
Associate Administrator for Rulemaking.
[FR Doc. 2011-20283 Filed 8-9-11; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 81, Number 58 (Friday, March 25, 2016)]
[Notices]
[Pages 16270-16275]
[FR Doc No: 2016-06759]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2016-0039]

NHTSA Enforcement Guidance Bulletin 2016-01; Guidance on
Submission and Treatment of Manufacturer Communications to Dealers,
Owners, or Purchasers About a Defect or Noncompliance

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation.

ACTION: Notice.

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SUMMARY: The National Highway Traffic Safety Administration (NHTSA) is
issuing this notice to make manufacturers aware of the statutory
requirement to index their communications to dealers, owners, or
purchasers about a defect or noncompliance, and to provide
recommendations for complying with the index requirement. Additionally,
a change in the law requires NHTSA to publicly post all such
communications on its Web site and it is therefore providing notice of
its intention to do so. NHTSA will also publicly post on its Web site
the manufacturers' indexes to their communications as they are
received.

FOR FURTHER INFORMATION CONTACT: For legal issues: Kerry Kolodziej,
Office of the Chief Counsel, NCC-100, National Highway Traffic Safety
Administration, 1200 New Jersey Avenue SE., Washington, DC 20590
(telephone:<PHONE_NUMBER>).
    For submission of documents pursuant to 49 CFR 579.5<EMAIL_ADDRESS>    For submission of documents pursuant to 49 CFR 573.6(c)(10):
Recalls Portal Help Desk, 1-888-719-9220<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The National Highway Traffic Safety
Administration (NHTSA or Agency) is issuing this notice of its intent
to enforce and implement the requirements of 49 U.S.C. 30166(f), as
amended by the Moving Ahead for Progress in the 21st Century Act (MAP-
21).

I. Legal and Policy Background

A. Manufacturers Are Required To Submit Copies to NHTSA of
Communications to Their Dealers, Owners, or Purchasers About a Defect
or Noncompliance

    The National Traffic and Motor Vehicle Safety Act (Safety Act), as
amended, requires motor vehicle and

motor vehicle equipment manufacturers to provide NHTSA with copies of
communications they send to their dealers, owners, or purchasers.
Specifically, the Safety Act requires manufacturers to submit ``a true
or representative copy of each communication to the manufacturer's
dealers or to owners or purchasers of a motor vehicle or replacement
equipment produced by the manufacturer about a defect or noncompliance
with a motor vehicle safety standard prescribed under this chapter in a
vehicle or equipment that is sold or serviced.'' 49 U.S.C. 30166(f).
This is a long-standing requirement. See Motor Vehicle and Schoolbus
Safety Amendments of 1974, Public Law 93-492, 158(a)(1), 88 Stat. 1470,
1475 (1974).
1. Scope of Submission Requirement
    The requirement for manufacturers to submit copies of their
communications to the Agency is broad and requires not only submission
of manufacturers' communications to dealers,\1\ owners, or purchasers
about vehicle and equipment recalls, but all communications ``about a
defect or noncompliance.'' 49 U.S.C. 30166(f)(1). With regard to
defects, the statutory submission requirement is not limited to
communications about safety-related defects. ``Defect'' is a
statutorily defined term meaning ``any defect in performance,
construction, a component, or material of a motor vehicle or motor
vehicle equipment.'' 49 U.S.C. 30102(a)(2). The plain language of the
provision requiring submission of copies of manufacturer communications
to the Agency does not condition use of the word ``defect'' to ``defect
related to motor vehicle safety,'' as is the case with other provisions
of the Safety Act. Compare 49 U.S.C. 30166(f), with 49 U.S.C.
30112(a)(3), 30118(a).
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    \1\ The Safety Act defines ``dealer'' as ``a person selling and
distributing new motor vehicles or motor vehicle equipment primarily
to purchasers that in good faith purchase the vehicles or equipment
other the for resale.'' 49 U.S.C. 30102(a)(1). Therefore the
requirement to submit communications to the Agency captures
communications including both those between a motor vehicle
manufacturer and its dealers and equipment suppliers and their motor
vehicle manufacturer customers. See 49 CFR 579.5.
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    Moreover, the Agency has long interpreted the requirement that
manufacturers submit copies of their communications to dealers, owners,
or purchasers as capturing all defect-related communications. See 49
CFR 579.5. In 1975, the Agency explained that the statute
``specifically authorizes the agency to require the submission'' of
communications about a defect, whether or not safety related. Proposed
Amendment, 49 FR 43227, 43228 (Sept. 19, 1975). The Agency explained
that this was important because ``[i]t is the responsibility of the
NHTSA, not the manufacturers, to make a final determination as to
whether or not a given defect is safety-related.'' Id. In 1978, the
Agency reiterated that the law ``specifically grants the agency [ ]
authority'' to collect all communications about a defect and rejected
the call from some commenters to limit the submissions to only
manufacturer communications about ``safety-related defects.'' Final
Rule, 43 FR 60165, 60168-69 (Dec. 28, 1978).
2. Implementing Regulations
    NHTSA implements the statutory requirement that manufacturers
submit representative copies of their communications to dealers,
owners, or purchasers through two regulations: One specifically
addressing recall communications, 49 CFR 573.6(c)(10), and the other
addressing manufacturer communications more broadly, 49 CFR 579.5.
    Many communications about a defect or noncompliance are
communications manufacturers make to their dealers, owners, or
purchasers about recalls. Some examples of these communications are
letters to dealers and vehicle owners informing them about a recall and
service bulletins (also known as technical service bulletins or TSBs)
that provide repair instructions for trained technicians performing the
recall remedy. NHTSA requires manufacturers to submit a representative
copy to NHTSA of recall communications ``not later than 5 days after
they are initially sent to manufacturers, distributors, dealers, or
purchasers.'' 49 CFR 573.6(c)(10). This applies to ``all notices,
bulletins, and other communications that relate directly to the defect
or noncompliance [that is the subject of a recall] and are sent to more
than one manufacturer, distributor, dealer or purchaser.'' Id.
    The second regulation that implements the requirement for
manufacturers to submit communications about a defect or noncompliance
to the Agency is 49 CFR 579.5. That requires manufacturers to submit
``a copy of all notices, bulletins, and other communications (including
those transmitted by computer, telefax, or other electronic means and
including warranty and policy extension communiqu[eacute]s and product
improvement bulletins) other than those required to be submitted
pursuant to Sec.  573.6(c)(10) of this chapter, sent to more than one
manufacturer, distributor, dealer, lessor, lessee, owner, or purchaser,
in the United States, regarding any defect in its vehicles or items of
equipment (including any failure or malfunction beyond normal
deterioration in use, or any failure of performance, or any flaw or
unintended deviation from design specifications), whether or not such
defect is safety-related.'' 49 CFR 579.5(a). It also requires that
``[e]ach manufacturer shall furnish to NHTSA a copy of each
communication relating to a customer satisfaction campaign, consumer
advisory, recall, or other safety activity involving the repair or
replacement of motor vehicles or equipment, that the manufacturer
issued to, or made available to, more than one dealer, distributor,
lessor, lessee, other manufacturer, owner, or purchaser, in the United
States.'' 49 CFR 579.5(b). Manufacturer communications required by 49
CFR 579.5 are due to the Agency ``not later than five working days
after the end of the month'' in which they were issued. 49 CFR
579.5(d).

B. NHTSA's Current Treatment of Manufacturer Communications Submitted
to the Agency

    It is important that manufacturers fully comply with the
requirement to submit copies of communications to their dealers,
owners, or purchasers about a defect or noncompliance so that the
Agency can effectively carry out its mission. Among other things, the
Agency reviews these communications to evaluate whether a safety issue
is involved, to engage in proactive communications with manufacturers
where there may be a misunderstanding or misidentification of the risk
of a particular issue that a manufacturer has decided to control and
remedy via a field action that is less than a recall, and to ensure
that recalls are carried out effectively.
    NHTSA posts a great deal of information on its Web site,
www.safercar.gov, including copies of many manufacturer communications.
NHTSA's Web site has a search tool that allows a user to search for
available documents and information by make, model, and model year of a
vehicle, or by brand name and other identifying information for motor
vehicle equipment.\2\ When a user performs a search, NHTSA's Web site
currently displays available documents and information in four
categories: (1) Recalls, (2) Defect Investigations, (3)

Complaints, and (4) Service Bulletins.\3\ NHTSA plans to rename the
``Service Bulletins'' category as ``Manufacturer Communications'' to
more fully reflect the available content. Each of these four categories
except ``Complaints,'' which are complaints submitted to the Agency
primarily by vehicle owners, may contain copies of manufacturer
communications submitted to the Agency.
---------------------------------------------------------------------------

    \2\ The search tool is currently available at http://www-odi.nhtsa.dot.gov/owners/SearchSafetyIssues.
    \3\ NHTSA presently provides summary information, but does not
post copies of service bulletins under the currently named ``Service
Bulletin'' portion of its Web site.
---------------------------------------------------------------------------

    Where manufacturer communications involve a recall (i.e., concern a
safety-related defect or noncompliance), the Agency makes them
available along with other recall-related documents under the
``Recalls'' section of its Web site. Other manufacturer communications
that relate to an Agency defect investigation (i.e., concern a
potential safety-related defect) are also available under the ``Defect
Investigations'' section of the Web site. Additionally, NHTSA posts
manufacturer communications about customer satisfaction campaigns
(i.e., concerning defects that have not been determined to pose an
unreasonable risk to motor vehicle safety) on the currently named
``Service Bulletins'' portion of its Web site. NHTSA also posts
information about service bulletins (i.e., repair instructions for
trained technicians) for issues that have not been determined to be a
safety-related defect or noncompliance on its Web site under the
currently named ``Service Bulletin'' section of its Web site. NHTSA
summarizes service bulletins and makes the summary available, along
with an option to request a copy of the documents.\4\
---------------------------------------------------------------------------

    \4\ NHTSA's Web site does not currently include summary
information on all service bulletins generated by a manufacturer.
Service bulletins for safety recalls in general are not included,
and also service bulletins which do not pertain to a safety issue
may not be included in the summaries provided.
---------------------------------------------------------------------------

II. New MAP-21 Requirements Regarding Manufacturer Communications
Submitted to the Agency

    MAP-21 amended the Safety Act to require manufacturers to submit
additional information to the Agency along with copies of their
communications and to require the Agency to make that additional
information and the communications themselves available on the Agency's
Web site.
    MAP-21 required manufacturers to accompany their submissions of
communications to the Agency with an index to each communication. MAP-
21, Public Law 112-141, Sec.  31303(a)(2), 126 Stat. 405, 764 (2012)
(codified at 49 U.S.C. 30166(f)(2)). Specifically, communications
manufacturers are required to submit to NHTSA under 49 U.S.C. 30166(f)
``shall be accompanied by an index to each communication, that--(A)
identifies the make, model, and model year of the affected vehicles;
[and] (B) includes a concise summary of the subject matter of the
communication.'' Id.
    While NHTSA already proactively made a substantial number of
manufacturer communications available to the public on its Web site,
MAP-21 also changed the law to make it mandatory for the Agency to post
all manufacturer communications to dealers, owners, or purchasers about
a defect or noncompliance on its Web site. See 49 U.S.C. 30166(f)(1).
Additionally, NHTSA must post the manufacturers' indexes to their
communications on its Web site in a searchable format. 49 U.S.C.
30166(f)(2).
    To implement these changes in the law, NHTSA is providing guidance
to manufacturers on the index requirement. This guidance is warranted
because manufacturers have not been submitting compliant indexes to the
Agency since the MAP-21 changes became effective on October 1, 2012.
See MAP-21, Public Law 112-141, Sec.  3, 126 Stat. 405, 413 (2012). In
addition to putting manufacturers on notice of this index requirement
and the Agency's intention to enforce it, providing guidance will also
help to ensure consistency in the format and content of manufacturer
indexes, thereby enabling the Agency to readily make the indexes
publicly available in a searchable format on its Web site.
    NHTSA is also providing notice of its intention to publicly post
all manufacturer communications submitted to the Agency pursuant to 49
U.S.C. 30166(f) on its Web site. MAP-21 requires NHTSA to post all
manufacturer communications to dealers, owners, or purchasers about a
defect or noncompliance. Prior to MAP-21, the Agency did not post
certain manufacturer communications (specifically, certain service
bulletins) on its Web site, which some manufacturers claimed to be
copyrighted documents. Congress in MAP-21's explicit requirement that
the Agency post ``each communication to the manufacturer's dealers or
to owners'' about a defect or noncompliance, has now made clear that
copyright law is not a restriction on NHTSA action.

III. Guidance Regarding Index Requirement

    The law now requires manufacturers to submit to NHTSA copies of
their communications to dealers, owners, or purchasers about a defect
or noncompliance and requires that such communications ``shall be
accompanied by an index to each communication.'' 49 U.S.C. 30166(f).
The index must identify the make, model, and model year of the affected
vehicles and include a concise summary of the subject matter of the
communication. 49 U.S.C. 30166(f)(2). This requirement has been in
effect since October 1, 2012. See MAP-21, Public Law 112-141, 3, 126
Stat. 405, 413 (2012).
    Most manufacturers comply with the long-standing requirement to
submit copies to the Agency of their communications to dealers, owners,
or purchasers about a defect or noncompliance.\5\ However,
manufacturers have not complied with the change in law requiring them
to accompany their communications to the Agency with indexes to those
communications.
---------------------------------------------------------------------------

    \5\ Where manufacturers have failed to comply with this
requirement, the Agency has taken enforcement action. See August 28,
2015 Consent Order, In re: AQ15-001, Triumph Motorcycles (America),
Ltd.; July 8, 2015 Consent Order, In re: AQ14-001, Forest River,
Inc.; July 8, 2015 Consent Order, In re: TQ14-003, Spartan Motors,
Inc. The Agency has also has and continues to take steps to educate
the industry about the communication submission requirement so that
the Agency receives this critical information.
---------------------------------------------------------------------------

    We are providing this guidance to make manufacturers aware of their
legal obligation to index their communications. The Agency expects all
manufacturers to expeditiously come into full compliance with the law
and will take additional action to enforce the index requirement as
necessary. The index requirement is subject to daily civil penalties.
See 49 U.S.C. 30165(a)(3).
    We are also providing this guidance to communicate to manufacturers
the content requirements for the index. We are providing
recommendations for preparing and submitting the index to help ensure
consistency across manufacturers and to enable the Agency to readily
make the indexes publicly available in a searchable format on its Web
site.

A. Which manufacturers must submit indexed communications to the
Agency?

    Every manufacturer of motor vehicles or motor vehicle equipment is
responsible both for submitting copies of communications to dealers,
owners, or purchasers and to provide an

accompanying index of those communications to the Agency. 49 U.S.C.
30166(f). The Safety Act defines ``manufacturer'' broadly to mean ``a
person--(A) manufacturing or assembling motor vehicles or motor vehicle
equipment; or (B) importing motor vehicles or motor vehicle equipment
for resale.'' 49 U.S.C. 30102(a)(5).

B. What types of communications must a manufacturer index going
forward?

    As discussed in this notice, NHTSA implemented the requirement to
submit copies of communications to dealers, owners, or purchasers about
a defect or noncompliance through regulations at 49 CFR 573.6(c)(10)
and 49 CFR 579.5. Therefore, a manufacturer must accompany its future
submissions of all communications pursuant to these provisions with an
index that meets the statutory requirements.

C. How does a manufacturer come into compliance with the index
requirement for prior submissions?

    The index requirement became effective as of October 1, 2012. See
MAP-21, Public Law 112-141, 3, 126 Stat. 405, 413 (2012). No
manufacturer to date has submitted compliant indexes. Some
manufacturers have submitted incomplete indexes to their communications
that do not satisfy the statutory requirements. To come into full
compliance with the law, a manufacturer must submit complete indexes to
the communications it previously submitted to the Agency pursuant to 49
CFR 579.5 between October 1, 2012 and the present, along with copies of
all communications listed in the index.
    A compliant submission requires both a complete index and copies of
the indexed communications. See 49 U.S.C. 30166(f). A manufacturer may
not supplement its earlier submission of communications pursuant to 49
CFR 579.5 by providing an index only. While we understand that this may
necessitate, in many cases, manufacturers to resubmit a large quantity
of communications to the Agency, this is what the law requires. The
Agency must receive a full and complete submission of communications
accompanied by an index so that it may fulfill its statutory obligation
to make the communications and index available on its Web site.\6\
---------------------------------------------------------------------------

    \6\ An index must enable a user to locate the indexed
communications. NHTSA will provide each communication with a unique
identifier, linked to the manufacturer-provided index. NHTSA will
provide instructions on its Web site for using the unique identifier
to search for and retrieve the communication.
---------------------------------------------------------------------------

    While a manufacturer must accompany future submissions of
communications pursuant to 49 CFR 573.6(c)(10) (i.e., recall
communications) with an index, we are exercising our enforcement
discretion to deem prior submissions of these communications compliant
with this requirement. These are recall communications, such as letters
to owners or dealers informing them of the recall and service bulletins
regarding the recall repair. Manufacturers need not resubmit copies of
recall communications or an accompanying index.\7\
---------------------------------------------------------------------------

    \7\ This is not intended to limit the Agency's authority to make
future requests for documents or information. See 49 CFR 30166(b),
(e), (g).
---------------------------------------------------------------------------

    The Agency has long had a practice of posting recall communications
on its Web site along with a great deal of information about the
recall. As safety critical information, the Agency wants to avoid any
disruption that could occur by making changes to the recall portion of
its Web site. Moreover, changes are unnecessary. Recall communications
are already indexed and available on the Agency's Web site. Recall
communications are readily accessible through a searchable interface
that is familiar to public users of the Agency's Web site.

D. When are indexed communications due to the Agency?

    The law requires that communications submitted to the Agency
``shall be accompanied by an index.'' 49 U.S.C. 30166(f)(2). Therefore,
manufacturers should submit an index at the same time as they submit
communications to the Agency. As discussed above, 49 CFR 573.6(c)(10)
requires submission of recall communications ``not later than 5 days
after they are initially sent to manufacturers, distributors, dealers,
or purchasers.'' Manufacturer communications required by 49 CFR 579.5
are due to the Agency ``not later than five working days after the end
of the month'' in which they were issued. 49 CFR 579.5(d).
1. Current and Prospective Submissions of Communications
    The Agency expects manufacturers to make a good faith effort to
expeditiously comply with the requirement to provide an index to
accompany the communications they submit to the Agency. However, the
Agency recognizes that manufacturers will need to educate staff and may
need to change internal policies and procedures to begin complying with
this requirement. While the Agency is not excusing noncompliance with
the law, the Agency recognizes that the entire industry has been out of
compliance with the index requirement and intends to exercise its
enforcement discretion to allow manufacturers a reasonable period of
time from the date of this notice to come into compliance with the
index requirement on a going forward basis. However, manufacturers
should not delay providing communications to the Agency.
2. Retroactive Resubmissions of Indexed Communications
    The Agency will not excuse manufacturers from providing indexes for
communications submitted to the Agency pursuant to 49 CFR 579.5 on or
after October 1, 2012. For any communications previously submitted to
the Agency pursuant to 49 CFR 579.5 that were not accompanied by a
fully compliant index at the time of submission, manufacturers must
submit indexed communications to the Agency. As discussed above, this
requires an index along with resubmission of all communications listed
in the index. This is necessary to allow the Agency to fulfill its
statutory obligations.
    The Agency intends to exercise enforcement discretion to allow
manufacturers a reasonable period of time to resubmit indexed
communications required by 49 CFR 579.5. The Agency recognizes that, in
many cases, the volume of communications submitted to the Agency since
October 1, 2012 is significant. The Agency will take the volume of
communications into account in considering what constitutes a
reasonable period of time for a given manufacturer. In general, we
expect that a manufacturer will resubmit indexed communications on a
rolling basis until it achieves full compliance.
    In sum, the Agency is not specifying a deadline for compliance with
the index requirement before it expects to take enforcement action. All
manufacturers must begin immediately making a reasonable good faith
effort to take steps to comply expeditiously for both retroactive and
future submissions. The Agency will take any such actions into account
in evaluating whether a given manufacturer came into compliance with
the law within a reasonable period of time.

E. What are the penalties for not complying with the index requirement?

    Indexes are required by 49 U.S.C. 30166(f), therefore, failure to
provide indexes, or failure to provide timely or complete indexes, is
subject to civil

penalties under current law of up to $21,000 per violation per day and
up to a maximum penalty of $105 million for a related series of daily
violations. 49 U.S.C. 30165(a)(3); see Civil Penalty Factors, 81 FR
10520 (Mar. 1, 2016) (issuing final rule).

F. What information must the index contain?

    At a minimum, an index must identify the make, model, and model
year of the affected vehicles and must include a concise summary of the
subject matter of the communication. These are statutory requirements.
49 U.S.C. 30166(f)(2). This is mandatory information when applicable.
    However, the Agency recognizes that for communications submitted by
motor vehicle equipment manufacturers, in many cases, there are no
specific affected vehicles. This is also true for a limited number of
generalized communications by motor vehicle manufacturers. In such
cases, the manufacturer should include other identifying information
for the affected motor vehicles or motor vehicle equipment in lieu of
make, model, and model year information for specific affected
vehicles.\8\
---------------------------------------------------------------------------

    \8\ This does not excuse a motor vehicle manufacturer from
providing make, model, and model year information for affected
vehicles when that information is reasonably available. For example,
it is not sufficient for a motor vehicle manufacturer to include
vehicle platform information in its index instead of make and model.
---------------------------------------------------------------------------

    To help ensure consistency across manufacturers, the Agency is also
providing recommendations on the specific format and content of the
indexes. In addition to the recommendations provided in this notice,
the Agency may provide more detailed recommendations on a forthcoming
Web page at http://www-odi.nhtsa.dot.gov/mc/. The Agency will make
available a template index for download and will provide examples of
completed index entries on its Web site. The Agency encourages
manufacturers to continue to visit this Web page as the Agency may
refine its recommendations over time as it evaluates manufacturers'
index submissions. While we are providing guidance and recommendations
at this time, the Agency will evaluate the content and consistency of
index submissions across manufacturers to determine whether a future
rulemaking is warranted.
1. Recommended Format for Index
    NHTSA strongly recommends that manufacturers submit their indexes
as word searchable electronic files. While the Agency is not requiring
use of any particular software, to ensure compatibility, the Agency
requests that manufacturers submit indexes as searchable Microsoft
Excel files.
    The Agency recommends that a manufacturer list each communication
on a separate row in its index and include separate columns for each
item of discrete information included. For example, the index should
include separate columns for make, of the affected vehicles, model of
the affected vehicles, and model year of the affected vehicles. We
recommend including a separate row for each make, model, or model year
of vehicle affected by a single communication. In other words, a single
communication may populate multiple rows on an index. We also recommend
including a column for manufacturer communication identifier number, if
one is used.
    The Agency's Web site and template index available for download
will provide more specific recommendations and information on the
Agency's preferred format for manufacturer indexes. See http://www-odi.nhtsa.dot.gov/mc/ (forthcoming).
2. Recommendations for Preparing the Concise Summary
    At a minimum, NHTSA recommends that a concise summary of the
subject matter of a manufacturer's communication should identify the
defect or noncompliance, describe the effect of the defect or
noncompliance, and describe the purpose or type of the communication.
In many cases, simply repeating the subject line or title of a
communication will be insufficient. Likewise, a generic description
that does not actually summarize the communication or describes
multiple communications with minimal changes, such as ``service
bulletin number 123'' does not meet the statutory requirements. The
Agency will post examples of concise summaries on its Web site.

G. Recommended Method of Submitting the Indexed Communications to the
Agency

    NHTSA requests that manufacturers submit their indexed
communications to the Agency electronically. Electronic submission will
best enable the Agency to make the manufacturer communications and
searchable index available to the public on the Internet as the law
requires.
    As discussed above, manufacturers must index recall communications
that they submit to the Agency pursuant to 49 CFR 573.6(c)(10) and
communications that they submit pursuant to 49 CFR 579.5. Manufacturers
are required to submit recall communications through NHTSA's recalls
portal and should also submit their recall communication indexes
through the portal. See 49 CFR 573.9. For communications required by 49
CFR 579.5, NHTSA strongly recommends that manufacturers submit their
indexed communications electronically to<EMAIL_ADDRESS>See 49 CFR
579.6(a).
    We note that some manufacturers have had a past practice of
submitting multiple communications under 49 CFR 579.5 in a consolidated
format, such as a single large .pdf file. We strongly recommend that
manufacturers discontinue this practice, in order to ensure that each
communication listed in the manufacturer's index is a readily
identifiable separate document. The Agency would prefer to receive each
communication as a separate .pdf file.

IV. Notice of Intention to Publicly Post All Manufacturer
Communications About a Defect or Noncompliance on NHTSA's Web Site

    NHTSA has reevaluated the information that the law permits it to
make publicly available on its Web site in light of the changes made by
MAP-21. As a result, NHTSA is providing this notice of its intent to
publicly post all manufacturer communications submitted to it pursuant
to 49 U.S.C. 30166(f).
    The law now affirmatively requires NHTSA to ``make available on a
publicly accessible Internet Web site'' copies of communications to
manufacturers' dealers, owners, or purchasers about a defect or
noncompliance that manufacturers submit to the Agency.
    Prior to enactment of MAP-21, the Agency did not publicly post
copies of all service bulletins that it received.\9\ Some manufacturers
copyright their service bulletins. Service bulletins are a
manufacturer's repair instructions, and repair shops or other
interested individuals may purchase them from a commercial source.
---------------------------------------------------------------------------

    \9\ Although the law also limits the Agency's ability to
disclose confidential information, 49 U.S.C. 30167, manufacturers do
not treat these documents as confidential and, in the case of
service bulletins, make them available to the public through
commercial providers. See 49 CFR part 512.
---------------------------------------------------------------------------

    Pursuant to the fair use limitation on copyright, to date NHTSA has
posted on its Web site copies of service bulletins for recall repairs
and service bulletins related to its defect investigations. See 17
U.S.C. 107; see also 49 U.S.C. 30167(b). NHTSA also has made a paper
copy of other service bulletins available

to the public pursuant to the library provision of copyright law. See
17 U.S.C. 108.
    Congress necessarily made the decision in enacting MAP-21, that
copyright law does not restrict NHTSA from publicly posting copies of
all manufacturer communications received by the Agency pursuant to 49
U.S.C. 30166(f) on its Web site. Indeed, 49 U.S.C. 30166(f) expressly
requires the Agency to do so.
    MAP-21 trumps the limited waiver of sovereign immunity for
copyright infringement claims. See 28 U.S.C. 1498(b). Congress could
not have intended to allow manufacturers to assert copyright
infringement against the federal government based on the Agency's
publication of service bulletins and other manufacturer communications
on its Web site in light of the express statutory requirement that the
Agency do so. See Food & Drug Admin. v. Brown & Williamson Tobacco
Corp., 529 U.S. 120, 143 (2000) (``The classic judicial task of
reconciling many laws enacted over time, and getting them to `make
sense' in combination, necessarily assumes that the implications of a
statute may be altered by the implications of a later statute. This is
particularly so where the scope of the earlier statute is broad but the
subsequent statutes more specifically address the topic at hand . . . .
[A] specific policy embodied in a later federal statute should control
our construction of the earlier statute, even though it has not been
expressly amended.'') (internal quotation marks, brackets, and
citations omitted).
    Because the law directs the Agency to make manufacturer
communications publicly available on its Web site, the Agency is acting
to effectuate the law. The Agency will post on its Web site those
manufacturer communications submitted to the Agency on or after the
October 1, 2012 effective date of MAP-21 that are not already available
on the Agency's Web site. Going forward, the Agency intends to post to
its public Web site all manufacturer communications submitted pursuant
to 49 U.S.C. 30166(f), including documents submitted pursuant to 49 CFR
573.6(c)(10) or 579.5. The Agency will also post manufacturer indexes
for communications submitted to the Agency on or after October 1, 2012
on a rolling basis as compliant indexes are received. The Agency
intends to make manufacturer indexes available in a searchable format.
    Applicability/Legal Statement: This Enforcement Guidance Bulletin
sets forth NHTSA's current interpretation and thinking on this topic
and guiding principles and best practices to be utilized in complying
with the legal requirements of 49 U.S.C. 30166(f). This Bulletin is not
a final agency action and is intended as guidance only. This Bulletin
is not intended, nor can it be relied upon, to create any rights
enforceable by any party against NHTSA, the Department of
Transportation, or the United States. Moreover, these recommended
practices to not establish any defense to any violations of the
statutes and regulations that NHTSA administers. This Bulletin may be
revised without notice to reflect changes in NHTSA's evaluation and
analysis, or to clarify and update text.

    Authority: 49 U.S.C. 30101, et seq.; 49 U.S.C. 30165(a)(3),
30166(f); delegations of authority at 49 CFR 1.95(a), 501.2(a)(1),
501.5.

    Issued on: March 21, 2016.
Paul A. Hemmersbaugh,
Chief Counsel.
[FR Doc. 2016-06759 Filed 3-24-16; 8:45 am]
 BILLING CODE 4910-59-P


0.516129032258065	6.61	6.504	6.282	5.608	5.398	4.189

0.548387096774194	6.473	6.41	6.085	5.605	5.359	4.187

0.580645161290323	6.45	6.356	6.001	5.559	5.231	4.135

0.612903225806452	6.391	6.294	5.914	5.534	5.23	3.943

0.645161290322581	6.179	6.09	5.833	5.444	5.2	3.915

0.67741935483871	6.17	6.087	5.803	5.271	5.142	3.736

0.709677419354839	5.958	5.866	5.509	5.019	4.959	3.717

0.741935483870968	5.824	5.735	5.415	4.998	4.852	3.683

0.774193548387097	5.676	5.611	5.408	4.958	4.763	3.348

0.806451612903226	5.676	5.586	5.231	4.626	4.317	3.288

0.838709677419355	5.395	5.314	4.993	4.425	4.168	3.167

0.870967741935484	4.994	4.915	4.604	4.152	4.15	2.938

0.903225806451613	4.973	4.894	4.597	4.144	3.904	2.931

0.935483870967742	4.921	4.845	4.547	4.055	3.837	2.899

0.967741935483871	4.712	4.633	4.322	4.04	3.791	2.84

0.1	10.761	10.564	9.9418	8.8613	8.2842	5.0376

					Average of yearly averages:	4.13786666666667

Inputs generated by pe4.pl - 8-August-2003

Data used for this run:

Output File: FPATuA

Metfile:	w14737.dvf

PRZM scenario:	PAturfC.txt

EXAMS environment file:	ir298.exv

Chemical Name:	Fluopicolide

Description	Variable Name	Value	Units	Comments

Molecular weight	mwt	383.59	g/mol

Henry's Law Const.	henry	4.11e-10	atm-m^3/mol

Vapor Pressure	vapr	2.28e-9	torr

Solubility	sol	3.02	mg/L

Kd	Kd		mg/L

Koc	Koc	340	mg/L

Photolysis half-life	kdp	170	days	Half-life

Aerobic Aquatic Metabolism	kbacw	146.4	days	Halfife

Anaerobic Aquatic Metabolism	kbacs	2162	days	Halfife

Aerobic Soil Metabolism	asm	454.5	days	Halfife

Hydrolysis:	pH 7	0	days	Half-life

Method:	CAM	2	integer	See PRZM manual

Incorporation Depth:	DEPI	0	cm

Application Rate:	TAPP	0.3024	kg/ha

Application Efficiency:	APPEFF	0.95	fraction

Spray Drift	DRFT	0.16	fraction of application rate applied to pond

Application Date	Date	01-07	dd/mm or dd/mmm or dd-mm or dd-mmm

Interval 1	interval	14	days	Set to 0 or delete line for single app.

Record 17:	FILTRA

	IPSCND	1

	UPTKF

Record 18:	PLVKRT

	PLDKRT	0.0198

	FEXTRC	0.5

Flag for Index Res. Run	IR	IR

Flag for runoff calc.	RUNOFF	total	none, monthly or total(average of entire run)

stored as FPATuG.out

Chemical: Fluopicolide

PRZM environment: PAturfC.txt	modified Satday, 12 October 2002 at 15:27:02

EXAMS environment: ir298.exv	modified Thuday, 29 August 2002 at 14:34:12

Metfile: w14737.dvf	modified Wedday, 3 July 2002 at 08:06:12

Water segment concentrations (ppb)

Year	Peak	96 hr	21 Day	60 Day	90 Day	Yearly

1961	9.29	9.119	8.462	7.592	6.904	2.686

1962	4.603	4.57	4.355	3.934	3.69	3.177

1963	4.093	4.043	3.913	3.617	3.447	2.569

1964	2.825	2.786	2.715	2.587	2.494	2.111

1965	2.306	2.272	2.14	2.043	1.978	1.619

1966	2.804	2.77	2.68	2.515	2.457	1.663

1967	3.37	3.319	3.123	2.938	2.826	2.001

1968	2.351	2.315	2.177	1.94	1.828	1.536

1969	10.56	10.38	9.679	8.385	7.683	3.469

1970	5.498	5.419	5.254	4.82	4.519	3.862

1971	7.723	7.607	7.238	6.888	6.536	3.974

1972	6.245	6.18	5.892	5.289	4.927	3.95

1973	4.18	4.128	3.923	3.592	3.408	2.976

1974	4.543	4.475	4.223	3.857	3.665	2.696

1975	4.158	4.093	3.953	3.528	3.335	2.475

1976	8.496	8.381	7.852	7.184	6.842	3.587

1977	4.841	4.814	4.704	4.476	4.307	3.438

1978	6.815	6.702	6.271	5.588	5.197	3.113

1979	5.028	4.968	4.78	4.559	4.57	3.44

1980	3.415	3.398	3.328	3.18	3.072	2.489

1981	2.417	2.381	2.254	2.018	1.94	1.702

1982	10.2	10.03	9.373	8.224	7.566	3.435

1983	4.816	4.79	4.684	4.463	4.3	3.403

1984	5.893	5.797	5.639	5.113	4.769	3

1985	7.436	7.314	7.036	6.214	6.042	3.703

1986	4.279	4.257	4.165	3.971	3.829	3.169

1987	7.429	7.321	6.925	6.684	6.377	3.511

1988	5.398	5.312	5.012	4.625	4.362	3.667

1989	3.78	3.735	3.567	3.297	3.284	2.723

1990	8.588	8.446	7.89	6.928	6.404	3.668

Sorted results

Prob.	Peak	96 hr	21 Day	60 Day	90 Day	Yearly

0.032258064516129	10.56	10.38	9.679	8.385	7.683	3.974

0.0645161290322581	10.2	10.03	9.373	8.224	7.566	3.95

0.0967741935483871	9.29	9.119	8.462	7.592	6.904	3.862

0.129032258064516	8.588	8.446	7.89	7.184	6.842	3.703

0.161290322580645	8.496	8.381	7.852	6.928	6.536	3.668

0.193548387096774	7.723	7.607	7.238	6.888	6.404	3.667

0.225806451612903	7.436	7.321	7.036	6.684	6.377	3.587

0.258064516129032	7.429	7.314	6.925	6.214	6.042	3.511

0.290322580645161	6.815	6.702	6.271	5.588	5.197	3.469

0.32258064516129	6.245	6.18	5.892	5.289	4.927	3.44

0.354838709677419	5.893	5.797	5.639	5.113	4.769	3.438

0.387096774193548	5.498	5.419	5.254	4.82	4.57	3.435

0.419354838709677	5.398	5.312	5.012	4.625	4.519	3.403

0.451612903225806	5.028	4.968	4.78	4.559	4.362	3.177

0.483870967741936	4.841	4.814	4.704	4.476	4.307	3.169

0.516129032258065	4.816	4.79	4.684	4.463	4.3	3.113

0.548387096774194	4.603	4.57	4.355	3.971	3.829	3

0.580645161290323	4.543	4.475	4.223	3.934	3.69	2.976

0.612903225806452	4.279	4.257	4.165	3.857	3.665	2.723

0.645161290322581	4.18	4.128	3.953	3.617	3.447	2.696

0.67741935483871	4.158	4.093	3.923	3.592	3.408	2.686

0.709677419354839	4.093	4.043	3.913	3.528	3.335	2.569

0.741935483870968	3.78	3.735	3.567	3.297	3.284	2.489

0.774193548387097	3.415	3.398	3.328	3.18	3.072	2.475

0.806451612903226	3.37	3.319	3.123	2.938	2.826	2.111

0.838709677419355	2.825	2.786	2.715	2.587	2.494	2.001

0.870967741935484	2.804	2.77	2.68	2.515	2.457	1.702

0.903225806451613	2.417	2.381	2.254	2.043	1.978	1.663

0.935483870967742	2.351	2.315	2.177	2.018	1.94	1.619

0.967741935483871	2.306	2.272	2.14	1.94	1.828	1.536

0.1	9.2198	9.0517	8.4048	7.5512	6.8978	3.8461

					Average of yearly averages:	2.9604

Inputs generated by pe4.pl - 8-August-2003

Data used for this run:

Output File: FPATuG

Metfile:	w14737.dvf

PRZM scenario:	PAturfC.txt

EXAMS environment file:	ir298.exv

Chemical Name:	Fluopicolide

Description	Variable Name	Value	Units	Comments

Molecular weight	mwt	383.59	g/mol

Henry's Law Const.	henry	4.11e-10	atm-m^3/mol

Vapor Pressure	vapr	2.28e-9	torr

Solubility	sol	3.02	mg/L

Kd	Kd		mg/L

Koc	Koc	340	mg/L

Photolysis half-life	kdp	170	days	Half-life

Aerobic Aquatic Metabolism	kbacw	146.4	days	Halfife

Anaerobic Aquatic Metabolism	kbacs	2162	days	Halfife

Aerobic Soil Metabolism	asm	454.5	days	Halfife

Hydrolysis:	pH 7	0	days	Half-life

Method:	CAM	2	integer	See PRZM manual

Incorporation Depth:	DEPI	0	cm

Application Rate:	TAPP	0.3024	kg/ha

Application Efficiency:	APPEFF	0.99	fraction

Spray Drift	DRFT	0.064	fraction of application rate applied to pond

Application Date	Date	01-07	dd/mm or dd/mmm or dd-mm or dd-mmm

Interval 1	interval	14	days	Set to 0 or delete line for single app.

Record 17:	FILTRA

	IPSCND	1

	UPTKF

Record 18:	PLVKRT

	PLDKRT	0.0198

	FEXTRC	0.5

Flag for Index Res. Run	IR	IR

Flag for runoff calc.	RUNOFF	total	none, monthly or total(average of entire run)

Appendix B – SCI-GROW outputs

For leafy vegetables, fruiting vegetables, cucurbit vegetables, potatoes, and grapes

(4 applications of 0.125 lb ai/ac)

SciGrow version 2.3

chemical:Fluopicolide

time is  2/ 9/2007  12: 5: 3

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

  Application      Number of       Total Use    Koc      Soil Aerobic

  rate (lb/acre)  applications   (lb/acre/yr)  (ml/g)   metabolism (days)

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

      0.125           4.0           0.500      3.49E+02      413.0

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

 groundwater screening cond (ppb) =   5.87E-01

 *********************************************************************** *

For turf (2 applications of 0.270 lb ai/ac)

                           SCIGROW

                          VERSION 2.3

            ENVIRONMENTAL FATE AND EFFECTS DIVISION

                 OFFICE OF PESTICIDE PROGRAMS

             U.S. ENVIRONMENTAL PROTECTION AGENCY

                        SCREENING MODEL

                FOR AQUATIC PESTICIDE EXPOSURE

 SciGrow version 2.3

 chemical:Fluopicolide

 time is  2/ 9/〲㜰†㈱›㨵㘱‍ⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭ ⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭ‍䄠灰 楬慣楴湯†††畎扭牥漠†††潔慴獕†䬠捯† ††潓汩䄠牥扯捩‍爠瑡氨⽢捡敲
愠灰楬慣楴湯⁳ †氨⽢捡敲礯⥲†洨⽬⥧†洠瑥扡汯獩搨祡⥳

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      0.270           2.0           0.540      3.49E+02      413.0

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

 groundwater screening cond (ppb) =   6.34E-01

 *********************************************************************** *

 PAGE

 PAGE   4


[Federal Register Volume 87, Number 66 (Wednesday, April 6, 2022)]
[Notices]
[Pages 19965-19967]
[FR Doc No: 2022-07296]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2022-0002]

Final Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.

ACTION: Notice.

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

SUMMARY: Flood hazard determinations, which may include additions or
modifications of Base Flood Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA) boundaries or zone designations, or
regulatory floodways on the Flood Insurance Rate Maps (FIRMs) and where
applicable, in the supporting Flood Insurance Study (FIS) reports have
been made final for the communities listed in the table below. The FIRM
and FIS report are the basis of the floodplain management measures that
a community is required either to adopt or to show evidence of having
in effect in order to qualify or remain qualified for participation in
the Federal Emergency Management Agency's (FEMA's) National Flood
Insurance Program (NFIP).

DATES: The date of July 19, 2022 has been established for the FIRM and,
where applicable, the supporting FIS report showing the new or modified
flood hazard information for each community.

ADDRESSES: The FIRM, and if applicable, the FIS report containing the
final flood hazard information for each community is available for
inspection at the respective Community Map Repository address listed in
the tables below and will be available online through the FEMA Map
Service Center at https://msc.fema.gov by the date indicated above.

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
[email protected]; or visit the FEMA Mapping and Insurance
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) makes the final determinations listed below for the new or
modified flood hazard information for each community listed.
Notification of these changes has been published in newspapers of local
circulation and 90 days have elapsed since that publication. The Deputy
Associate Administrator for Insurance and Mitigation has resolved any
appeals resulting from this notification.
    This final notice is issued in accordance with section 110 of the
Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part
67. FEMA has developed criteria for floodplain management in floodprone
areas in accordance with 44 CFR part 60.
    Interested lessees and owners of real property are encouraged to
review the

new or revised FIRM and FIS report available at the address cited below
for each community or online through the FEMA Map Service Center at
https://msc.fema.gov.
    The flood hazard determinations are made final in the watersheds
and/or communities listed in the table below.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
             Coconino County, Arizona and Incorporated Areas
                         Docket No.: FEMA-B-2113
------------------------------------------------------------------------
Unincorporated Areas of Coconino County  Community Development
                                          Department, 2500 North Fort
                                          Valley Road, Building 1,
                                          Flagstaff, AZ 86001.
------------------------------------------------------------------------
            Woodruff County, Arkansas and Incorporated Areas
                         Docket No.: FEMA-B-2115
------------------------------------------------------------------------
City of Augusta........................  City Hall, 210 Main Street,
                                          Augusta, AR 72006.
City of Cotton Plant...................  City Hall, 110 Central Avenue,
                                          Cotton Plant, AR 72036.
City of McCrory........................  City Hall, 109 North Jackson
                                          Street, McCrory, AR 72101.
City of Patterson......................  City Hall, 123 South Main
                                          Street, Patterson, AR 72123.
Town of Hunter.........................  Woodruff County Courthouse, 500
                                          North 3rd Street, Augusta, AR
                                          72006.
Unincorporated Areas of Woodruff County  Woodruff County Courthouse, 500
                                          North 3rd Street, Augusta, AR
                                          72006.
------------------------------------------------------------------------
            Sonoma County, California and Incorporated Areas
                         Docket No.: FEMA-B-2058
------------------------------------------------------------------------
City of Rohnert Park...................  Development Services
                                          Department, City Hall, 130
                                          Avram Avenue, Rohnert Park, CA
                                          94928.
Unincorporated Areas of Sonoma County..  Sonoma County Permit and
                                          Resource Management, 2550
                                          Ventura Avenue, Santa Rosa, CA
                                          95403.
------------------------------------------------------------------------
              Morris County, Kansas and Incorporated Areas
                         Docket No.: FEMA-B-2135
------------------------------------------------------------------------
City of Council Grove..................  City Hall, 205 Union Street,
                                          Council Grove, KS 66846.
City of Dunlap.........................  Morris County Courthouse, 501
                                          West Main Street, Council
                                          Grove, KS 66846.
City of Parkerville....................  Morris County Courthouse, 501
                                          West Main Street, Council
                                          Grove, KS 66846.
Unincorporated Areas of Morris County..  Morris County Courthouse, 501
                                          West Main Street, Council
                                          Grove, KS 66846.
------------------------------------------------------------------------
             Cheboygan County, Michigan (All Jurisdictions)
                         Docket No.: FEMA-B-2114
------------------------------------------------------------------------
City of Cheboygan......................  City Hall, 403 North Huron
                                          Street, Cheboygan, MI 49721.
Township of Beaugrand..................  Beaugrand Township Hall, 1999
                                          Old Mackinaw Road, Cheboygan,
                                          MI 49721.
Township of Benton.....................  Benton Township Hall, 5012
                                          Orchard Beach Road, Cheboygan,
                                          MI 49721.
Township of Mackinaw...................  Mackinaw Township Hall, 10595
                                          Wallick Road, Mackinaw City,
                                          MI 49701.
Village of Mackinaw City...............  Village Hall, 102 South Huron
                                          Avenue, Mackinaw City, MI
                                          49701.
------------------------------------------------------------------------
             St. Clair County, Michigan (All Jurisdictions)
                         Docket No.: FEMA-B-1933
------------------------------------------------------------------------
Township of Clay.......................  Clay Township Offices, 4710
                                          Pointe Tremble Road, Algonac,
                                          MI 48001.
Township of Cottrellville..............  Township Hall, 7008 Marsh Road,
                                          Cottrellville, MI 48039.
Township of Ira........................  Ira Township Hall, 7085 Meldrum
                                          Road, Fair Haven, MI 48023.
------------------------------------------------------------------------
             St. Clair County, Michigan (All Jurisdictions)
                         Docket No.: FEMA-B-2104
------------------------------------------------------------------------
Charter Township of Fort Gratiot.......  Municipal Center, 3720
                                          Keewahdin Road, Fort Gratiot,
                                          MI 48059.
City of Port Huron.....................  Municipal Office Center, 100
                                          McMorran Boulevard, Port
                                          Huron, MI 48060.
Township of Burtchville................  Township Hall, 4000 Burtch
                                          Road, Burtchville, MI 48059.
Charter Township of Port Huron.........  Township Office, 3800 Lapeer
                                          Road, Port Huron, MI 48060.
------------------------------------------------------------------------

          Chatham County, North Carolina and Incorporated Areas
                         Docket No.: FEMA-B-1616
------------------------------------------------------------------------
Unincorporated Areas of Chatham County.  Chatham County Planning
                                          Department, 80-A East Street,
                                          Pittsboro, NC 27312.
------------------------------------------------------------------------
          Durham County, North Carolina and Incorporated Areas
                         Docket No.: FEMA-B-1616
------------------------------------------------------------------------
City of Durham.........................  City-County Inspections
                                          Department, 101 City Hall
                                          Plaza, Durham, NC 27701.
City of Raleigh........................  Engineering Services
                                          Department, One Exchange
                                          Plaza, Suite 706, Raleigh, NC
                                          27601.
Town of Morrisville....................  Town Hall, 100 Town Hall Drive,
                                          Morrisville, NC 27560.
Unincorporated Areas of Durham County..  Durham County, City-County
                                          Inspections Department, 101
                                          City Hall Plaza, Durham, NC
                                          27701.
------------------------------------------------------------------------
         Franklin County, North Carolina and Incorporated Areas
                         Docket No.: FEMA-B-1616
------------------------------------------------------------------------
Unincorporated Areas of Franklin County  Franklin County Planning and
                                          Inspections, 215 East Nash
                                          Street, Louisburg, NC 27549.
------------------------------------------------------------------------
         Johnston County, North Carolina and Incorporated Areas
                 Docket No.: FEMA-B-1445 and FEMA-B-1616
------------------------------------------------------------------------
Town of Clayton........................  Town Hall, 111 East 2nd Street,
                                          Clayton, NC 27520.
Unincorporated Areas of Johnston County  Johnston County Planning
                                          Department, 309 East Market
                                          Street, Smithfield, NC 27577.
------------------------------------------------------------------------
           Wake County, North Carolina and Incorporated Areas
                 Docket No.: FEMA-B-1616 and FEMA-B-2102
------------------------------------------------------------------------
City of Raleigh........................  Engineering Services
                                          Department, One Exchange
                                          Plaza, Suite 706, Raleigh, NC
                                          27601.
Town of Apex...........................  Engineering Department, 73
                                          Hunter Street, Apex, NC 27502.
Town of Cary...........................  Stormwater Services Division,
                                          316 North Academy Street,
                                          Cary, NC 27513.
Town of Fuquay-Varina..................  Engineering Department, 134
                                          North Main Street, Fuquay-
                                          Varina, NC 27526.
Town of Garner.........................  Engineering Department, 900 7th
                                          Avenue, Garner, NC 27529.
Town of Holly Springs..................  Engineering Department, 128
                                          South Main Street, Holly
                                          Springs, NC 27540.
Town of Knightdale.....................  Town Hall, 950 Steeple Square
                                          Court, Knightdale, NC 27545.
Town of Morrisville....................  Town Hall, 100 Town Hall Drive,
                                          Morrisville, NC 27560.
Town of Rolesville.....................  Planning Department, 502
                                          Southtown Circle, Rolesville,
                                          NC 27571.
Town of Wake Forest....................  Planning Department, 301 South
                                          Brooks Street, 3rd Floor, Wake
                                          Forest, NC 27587.
Town of Wendell........................  Planning Department, 15 East
                                          4th Street, Wendell, NC 27591.
Town of Zebulon........................  Planning Department, 1003 North
                                          Arendell Avenue, Zebulon, NC
                                          27597.
Unincorporated Areas of Wake County....  Wake County Environmental
                                          Services Department, Waverly
                                          F. Atkins Office Building, 337
                                          South Salisbury Street,
                                          Raleigh, NC 27601.
------------------------------------------------------------------------

[FR Doc. 2022-07296 Filed 4-5-22; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 79, Number 158 (Friday, August 15, 2014)]
[Rules and Regulations]
[Pages 48028-48030]
[FR Doc No: 2014-19228]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0219; Directorate Identifier 2014-NE-04-AD;
Amendment 39-17939; AD 2014-16-15]
RIN 2120-AA64

Airworthiness Directives; Turbomeca S.A. Turboshaft Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Turbomeca S.A. Makila 2A and Makila 2A1 turboshaft engines. This AD
requires initial and repetitive visual inspections, and replacement of
the splines of the high-pressure (HP) fuel pump/metering valve and the
module M01 drive gear, if necessary. This AD was prompted by the
failure of two HP fuel pumps that resulted in engine in-flight
shutdowns. We are issuing this AD to prevent failure of the HP fuel
pump, which could lead to an in-flight shutdown, damage to the engine,
and forced landing or accident.

DATES: This AD becomes effective September 19, 2014.

ADDRESSES: For service information identified in this AD, contact
Turbomeca, S.A., 40220 Tarnos, France; phone: 33 (0)5 59 74 40 00;
telex: 570 042; fax: 33 (0)5 59 74 45 15. You may view this service
information at the FAA, Engine & Propeller Directorate, 12 New England
Executive Park, Burlington, MA. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0219; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the mandatory continuing airworthiness information
(MCAI), the regulatory evaluation, any comments received, and other
information. The address for the Docket Office (phone:<PHONE_NUMBER>) is
Document Management Facility, U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Katheryn Malatek, Aerospace Engineer,
Engine Certification Office, FAA, Engine & Propeller Directorate, 12
New England Executive Park, Burlington, MA 01803; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to the specified products. The
NPRM was published in the Federal Register on May 12, 2014 (79 FR
26905). The NPRM proposed to correct an unsafe condition for the
specified products. The MCAI states:

    Two uncommanded in-flight shutdowns on Makila 2A/2A1 engines
have been reported. The results of the technical investigations
concluded that these events were caused by deterioration of the
splines on the high-pressure (HP) fuel pump drive link, which
eventually interrupted the fuel supply to the engine.
    This condition, if not detected and corrected, could lead to
further cases of uncommanded engine in-flight shutdown, and may
ultimately lead to an emergency landing.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (79 FR 26905, May 12,
2014).

Conclusion

    We reviewed the available data and determined that air safety and
the public interest require adopting this AD as proposed.

Costs of Compliance

    We estimate that this AD affects 8 engines installed on helicopters
of U.S. registry. We also estimate that it will take about 2 hours per
engine to comply with this AD. The average labor rate is $85 per hour.
Required parts cost about $750 per engine. Based on these figures, we
estimate the cost of this AD on U.S. operators to be $1,360.

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 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 to the extent
that it justifies making a regulatory distinction, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

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

Sec.  39.13  [Amended]

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

2014-16-15 Turbomeca S.A.: Amendment 39-17939; Docket No. FAA-2014-
0219; Directorate Identifier 2014-NE-04-AD.

(a) Effective Date

    This AD becomes effective September 19, 2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Turbomeca S.A. Makila 2A and Makila 2A1
turboshaft engines with a high-pressure (HP) fuel pump, part number
(P/N) 0 298 91 806 0 or P/N 0 298 91 805 0, installed, that have not
incorporated Turbomeca modification TU 59.

(d) Reason

    This AD was prompted by the failure of two HP fuel pumps that
resulted in engine in-flight shutdowns. We are issuing this AD to
prevent failure of the HP fuel pump, which could lead to an in-
flight shutdown, damage to the engine, and forced landing or
accident.

(e) Actions and Compliance

    Comply with this AD within the compliance times specified,
unless already done.
    (1) Within 25 flight hours (FHs) or 6 months after the effective
date of this AD, whichever occurs earlier, clean and visually
inspect the splines of the HP fuel pump/metering valve and the
module M01 drive gear for wear, corrosion, scaling, pitting, and
chafing.
    (2) Thereafter, reinspect every 100 FHs since-last-inspection.
    (3) If the HP fuel pump/metering valve or the module M01 drive
gear fails the inspection required by this AD, replace it with a
part eligible for installation before further flight.
    (4) After the effective date of this AD, do not install any HP
fuel pump, HP fuel pump drive shaft, module M01 drive gear, or
module M01 77-tooth gear onto any engine, or install any engine onto
any helicopter, unless the HP fuel pump/metering valve and the
module M01 drive gear passed the inspection required by paragraph
(e) of this AD.

(f) Alternative Methods of Compliance (AMOCs)

    The Manager, Engine Certification Office, FAA, may approve AMOCs
to this AD. Use the procedures found in 14 CFR 39.19 to make your
request.

(g) Related Information

    (1) For more information about this AD, contact Katheryn
Malatek, Aerospace Engineer, Engine Certification Office, FAA,
Engine & Propeller Directorate, 12 New England Executive Park,
Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) Refer to MCAI European Aviation Safety Agency (EASA) AD
2014-0059, dated March 10, 2014, and EASA AD 2014-0059R1, dated
April 15, 2014, for more information. You may examine the MCAIs in
the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2014-0219-0003.
    (3) Turbomeca S.A. Mandatory Service Bulletin No. 298 73 2818,
Version F, dated March 5, 2014, which is not incorporated by
reference in this AD, can be obtained from Turbomeca S.A., using the
contact information in paragraph (g)(4) of this AD.
    (4) For service information identified in this AD, contact
Turbomeca, S.A., 40220 Tarnos, France; phone: 33 (0)5 59 74 40 00;
telex: 570 042; fax: 33 (0)5 59 74 45 15.

    (5) You may view this service information at the FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington,
MA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

(h) Material Incorporated by Reference

    None.

    Issued in Burlington, Massachusetts, on August 6, 2014.
Colleen M. D'Alessandro,
Assistant Directorate Manager, Engine & Propeller Directorate, Aircraft
Certification Service.
[FR Doc. 2014-19228 Filed 8-14-14; 8:45 am]
BILLING CODE 4910-13-P