[Federal Register Volume 81, Number 131 (Friday, July 8, 2016)]
[Rules and Regulations]
[Pages 44489-44492]
[FR Doc No: 2016-15902]

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Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

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Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Rules
and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-4202; Directorate Identifier 2014-NM-016-AD;
Amendment 39-18583; AD 2016-14-02]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

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

ACTION: Final rule.

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SUMMARY: We are superseding Airworthiness Directive (AD) 2012-18-12 for
certain Airbus Model A318, A319, and A320 series airplanes. AD 2012-18-
12 required modifying the off-wing escape slide (OWS) enclosures on the
left-hand (LH) side and right-hand (RH) side of the fuselage. This new
AD retains the requirements of AD 2012-18-12 and expands the
applicability to all Airbus Model A318, A319, and A320 series
airplanes. This AD was prompted by reports that additional OWS part
numbers have been affected. We are issuing this AD to prevent off-wing
exits on the LH and RH sides of the fuselage from becoming inoperative.
During an emergency, inoperative off-wing exits could impair the safe
evacuation of occupants, possibly resulting in personal injuries.

DATES: This AD becomes effective August 12, 2016.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of August 12,
2016.
    The Director of the Federal Register approved the incorporation by
reference of a certain other publication listed in this AD as of
October 22, 2012 (77 FR 57003, September 17, 2012).

ADDRESSES: For Airbus service information identified in this final
rule, contact Airbus, Airworthiness Office--EIAS, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax
+33 5 61 93 44 51; email<EMAIL_ADDRESS>Internet
http://www.airbus.com.
    For Air Cruisers service information identified in this final rule,
contact Air Cruisers Company, Cage Code 70167, 1747 State Route 34,
Wall Township, NJ 07727-3935; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>;
Internet http://www.zodiacaerospace.com/en/our-activities/aerosafety/zodiac-evacuation-systems.
    For information on the availability of this material at the FAA,
call<PHONE_NUMBER>. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
4202.

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-2015-
4202; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The address for the Docket Office (telephone 800-
647-5527) is Docket Management Facility, U.S. Department of
Transportation, Docket Operations, M 30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to supersede AD 2012-18-12, Amendment 39-17189 (77 FR 57003,
September 17, 2012) (``AD 2012-18-12''). AD 2012-18-12 applied to
certain Airbus Model A318, A319, and A320 series airplanes. The NPRM
published in the Federal Register on October 23, 2015 (80 FR 64375)
(``the NPRM''). The NPRM was prompted by reports that additional OWS
part numbers have been affected. The NPRM proposed to retain the
requirements of AD 2012-18-12, and to expand the applicability to all
Airbus Model A318, A319, and A320 series airplanes. We are issuing this
AD to prevent off-wing exits on the LH and RH sides of the fuselage
from becoming inoperative. During an emergency, inoperative off-wing
exits could impair the safe evacuation of occupants, possibly resulting
in personal injuries.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive 2014-0025R1, dated May 26, 2014 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition on all Airbus Model A318,
A319, and A320 series airplanes. The MCAI states:

    One operator reported a torn out aspirator during scheduled
deployment (for on ground testing purposes) of the Left Hand (LH)
off-wing [escape] slide (OWS). Investigation results revealed that
the aspirator of the OWS system interfered with the extrusion lip of
the OWS enclosure during the initial stage of the deployment
sequence.
    This condition, if not corrected, could lead to an off-wing
exit, either LH or Right Hand (RH), becoming unserviceable, which,
during an emergency situation, could impair the safe evacuation of
occupants, possibly resulting in personal injuries.
    To address this potential unsafe condition, Airbus issued
Service Bulletin (SB) A320-25-1649 containing modification
instructions for certain part number (P/N) OWS enclosures.
Consequently, EASA issued [EASA] AD 2010-0210 [http://ad.easa.europa.eu/ad/2010-0210, which corresponds to FAA AD 2012-18-
12] to require modification of the affected OWS enclosures.
    Since that [EASA] AD was issued, several other OWS P/N[s] have
been identified as potentially impacted.
    For the reason described above, this [EASA] AD retains the
requirements of EASA AD 2010-0210, which is superseded, expands the
Applicability to all A318, A319 and A320 aeroplanes, and expands the
batch of affected P/N[s] prohibited to be installed on an aeroplane.
    For the reason described above, EASA issued AD 2014-0025,
retaining the requirements of EASA AD 2010-0210, which was
superseded, expanding the Applicability to all A318, A319 and A320
aeroplanes, and expanding the batch of affected P/N[s]

prohibited to be installed on an aeroplane. That [EASA] AD also
retained the requirements of * * * [an AD, which was superseded],
which required modification of the OWS and its aspirator.
    This [EASA] AD is revised to amend paragraphs (1) and (3) to
restore the original applicability of [a Direction
G[eacute]n[eacute]rale de l'Aviation Civile] DGAC France AD and EASA
AD 2010-0210, respectively, and to correct paragraph (2) to give
credit for certain production modifications that were equivalent for
the in-service actions previously required by [a] DGAC France AD.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
4202.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comment received on the NPRM and
the FAA's response to the comment.

Request To Change Parts Installation Prohibitions

    United Airlines (United) asked for clarification of the language in
paragraph (k) of the proposed AD, which would prohibit the installation
of OWS part numbers (P/Ns) including D31865-109, D31865-110, D31865-
209, and D31865-210, as identified in paragraph (h)(2) of the proposed
AD, but also specifies accomplishing the modification required by
paragraph (g) of the proposed AD. United stated that the modification
converts those part numbers into D31865-309, D31865-311, D31865-310,
and D31865-312, respectively. Therefore, United suggested we remove any
language allowing installation of P/Ns D31865-109, D31865-110, D31865-
209, and D31865-210 from the proposed AD.
    We agree that clarification is necessary. We have moved the
language in paragraph (h)(1) of the proposed AD into paragraph (h) of
this AD and removed paragraph (h)(2) from this AD. We have also removed
the language in paragraph (k) of the proposed AD which specified
``except as required by paragraph (h)(2) of this AD for the OWS
enclosures identified in paragraph (h) of this AD.'' And where
paragraph (l)(2) of the proposed AD referred to ``paragraph (h)(2),''
we have changed this reference to paragraph (h) of this AD.

Conclusion

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

Related Service Information Under 1 CFR Part 51

    Airbus has issued the following service information.
     Airbus Service Bulletin A320-25-1156, Revision 03, dated
December 5, 2001. This service information describes procedures for
modifying OWS enclosures having P/Ns D31865-101, D31865-102, D31865-
103, D31865-104, D31865-105, D31865-106, D31865-107, or D31865-108 of
certain Airbus Model A319 and A320 series airplanes.
     Airbus Service Bulletin A320-25-1649, dated February 16,
2010. This service information describes procedures for modifying and
installing OWS enclosures having P/Ns D31865-109, D31865-110, D31865-
209, or D31865-210, on the LH and RH sides of the fuselage on certain
Airbus Model A318, A319, and A320 series airplanes.
    Air Cruisers has issued Service Bulletin A320 004-25-84, Revision
4, dated November 9, 2012. This service information describes
procedures for modifying the LH and RH OWS.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 851 airplanes of U.S. registry.
    The actions required by AD 2012-18-12 and retained in this AD take
about 14 work-hours per product, at an average labor rate of $85 per
work-hour. Required parts will cost $0 per product. Based on these
figures, the estimated cost of the actions that are required by AD
2012-18-12 is $1,190 per product.
    We also estimate that it takes about 48 work-hours per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour. Required parts will cost $0 per product. Based on
these figures, we estimate the cost of this AD on U.S. operators to be
$3,472,080, or $4,080 per product.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2012-18-12, Amendment 39-17189 (77 FR 57003, September 17, 2012), and
adding the following new AD:

2016-14-02 Airbus: Amendment 39-18583. Docket No. FAA-2015-4202;
Directorate Identifier 2014-NM-016-AD.

(a) Effective Date

    This AD becomes effective August 12, 2016.

(b) Affected ADs

    This AD replaces (AD) 2012-18-12, Amendment 39-17189 (77 FR
57003, September 17, 2012) (``AD 2012-18-12'').

(c) Applicability

    This AD applies to the Airbus airplanes identified in paragraphs
(c)(1), (c)(2), and (c)(3) of this AD, certificated in any category,
all manufacturer serial numbers.
    (1) Model A318-111, -112, -121, and -122 airplanes.
    (2) Model A319-111, -112, -113, -114, -115, -131, -132, and -133
airplanes.
    (3) Model 320-211, -212, -214, -231, -232, and -233 airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 25, Equipment/
furnishings.

(e) Reason

    This AD was prompted by reports that additional OWS part numbers
have been affected. We are issuing this AD to prevent off-wing exits
on the left-hand (LH) and right-hand (RH) sides of the fuselage from
becoming inoperative. During an emergency, inoperative off-wing
exits could impair the safe evacuation of occupants, possibly
resulting in personal injuries.

(f) Compliance

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

(g) Retained Modification

    This paragraph restates the requirements of paragraph (g) of AD
2012-18-12, with no changes. For airplanes equipped with OWS
enclosures having part number (P/N) D31865-109, D31865-110, D31865-
209, or D31865-210, except as provided by paragraph (i)(1) of this
AD: Within 36 months after October 22, 2012 (the effective date of
AD 2012-18-12), modify the OWS enclosures and install an OWS
enclosure having P/N D31865-309, D31865-311, D31865-310, or D31865-
312 on the LH side and RH side of the fuselage, in accordance with
the Accomplishment Instructions of Airbus Service Bulletin A320-25-
1649, dated February 16, 2010.

(h) New Modification of Affected OWS Enclosures and Aspirators

    For airplanes equipped with an OWS enclosure having P/N D31865-
101, D31865-102, D31865-103, D31865-104, D31865-105, D31865-106,
D31865-107, or D31865-108, except as provided by paragraph (i)(2) of
this AD: Within 36 months after the effective date of this AD,
modify the OWS enclosures and their aspirators in accordance with
the Accomplishment Instructions of Airbus Service Bulletin A320-25-
1156, Revision 03, dated December 5, 2001.

(i) Exceptions to the Requirements of Paragraphs (g) and (h) of This AD

    (1) Airplanes having Airbus Modification 30088 embodied in
production using an OWS enclosure having P/N D31865-111 or D31865-
112 are not affected by the requirements of paragraph (g) of this
AD, unless a replacement OWS enclosure, having a part number listed
in paragraphs (k)(9) through (k)(12) of this AD, has been installed
on that airplane since first flight.
    (2) Airplanes on which Airbus Modifications 24850, 25844, and
27275 have been embodied in production, or on which modifications of
the LH and RH OWS enclosures and their aspirators have been
accomplished using Airbus Service Bulletin A320-25-1156, Revision
01, dated February 2, 1999; or Revision 02, dated October 26, 1999;
and Airbus Service Bulletin A320-25-1265, dated June 6, 2001, are
compliant with the modification requirement of paragraph (h) of this
AD.

(j) Optional Method of Compliance for Paragraph (g) of This AD

    Installing both LH and RH OWS that have been modified in
accordance with the Accomplishment Instructions of Air Cruisers
Service Bulletin A320 004-25-84, Revision 4, dated November 9, 2012,
is an acceptable method of compliance with the modification required
by paragraph (g) of this AD.

(k) Part Installation Prohibition

    As of the effective date of this AD, do not install on any
airplane an OWS enclosure having a part number listed in paragraphs
(k)(1) through (k)(12) of this AD.
    (1) D31865-101.
    (2) D31865-102.
    (3) D31865-103.
    (4) D31865-104.
    (5) D31865-105.
    (6) D31865-106.
    (7) D31865-107.
    (8) D31865-108.
    (9) D31865-109.
    (10) D31865-110.
    (11) D31865-209.
    (12) D31865-210.

(l) Credit for Previous Actions

    (1) This paragraph provides credit for the actions specified in
paragraph (h) of this AD, if those actions were performed before the
effective date of this AD using the service information identified
in paragraph (l)(1)(i) or (l)(1)(ii) of this AD, which is not
incorporated by reference in this AD.
    (i) Airbus Service Bulletin A320-25-1156, Revision 01, dated
February 2, 1999.
    (ii) Airbus Service Bulletin A320-25-1156, Revision 02, dated
October 26, 1999.
    (2) This paragraph provides credit for the actions specified in
paragraph (h) of this AD, if those actions were performed before the
effective date of this AD using Airbus Service Bulletin A320-25-
1265, dated June 6, 2001, which is not incorporated by reference in
this AD.
    (3) This paragraph provides credit for the actions specified in
paragraph (j) of this AD, if those actions were performed before the
effective date of this AD using the service information identified
in paragraph (l)(3)(i), (l)(3)(ii), (l)(3)(iii), or (l)(3)(iv) of
this AD, which is not incorporated by reference in this AD.
    (i) Air Cruisers Service Bulletin A320 004-25-84, dated February
5, 2010.
    (ii) Air Cruisers Service Bulletin A320 004-25-84, Revision 1,
dated April 9, 2010.
    (iii) Air Cruisers Service Bulletin A320 004-25-84, Revision 2,
dated February 11, 2011.
    (iv) Air Cruisers Service Bulletin A320 004-25-84, Revision 3,
dated October 28, 2011.

(m) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Sanjay
Ralhan, Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-
3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information may be
emailed to<EMAIL_ADDRESS>    (i) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office. The AMOC approval letter must specifically
reference this AD.
    (ii) AMOCs approved previously for AD 2012-18-12 are approved as
AMOCs for the corresponding provisions of paragraph (g) of this AD.
    (2) Contacting the Manufacturer: As of the effective date of
this AD, for any requirement in this AD to obtain corrective actions
from a manufacturer, the action must be accomplished using a method
approved by the Manager, International Branch, ANM-116, Transport
Airplane Directorate, FAA; or the European Aviation Safety Agency
(EASA); or Airbus's EASA Design Organization Approval (DOA). If
approved by the DOA, the approval must include the DOA-authorized
signature.

(n) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA Airworthiness Directive 2014-0025R1, dated May 26, 2014,
for related information. This MCAI may be found in the AD docket on
the Internet at http://www.regulations.gov by searching for and
locating Docket No. FAA-2015-4202.
    (2) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (o)(5), (o)(6), and (o)(7) of this AD.

(o) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this

paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (3) The following service information was approved for IBR on
August 12, 2016.
    (i) Airbus Service Bulletin A320-25-1156, Revision 03, dated
December 5, 2001.
    (ii) Air Cruisers Service Bulletin A320 004-25-84, Revision 4,
dated November 9, 2012.
    (4) The following service information was approved for IBR on
October 22, 2012 (77 FR 57003, September 17, 2012).
    (i) Airbus Service Bulletin A320-25-1649, dated February 16,
2010.
    (ii) Reserved.
    (5) For Airbus service information identified in this AD,
contact Airbus, Airworthiness Office--EIAS, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 44 51; email<EMAIL_ADDRESS>
Internet http://www.airbus.com.
    (6) For Air Cruisers service information identified in this AD,
contact Air Cruisers Company, Cage Code 70167, 1747 State Route 34,
Wall Township, NJ 07727-3935; telephone<PHONE_NUMBER>; fax 732-681-
9163; Internet http://www.zodiacaerospace.com/en/our-activities/aerosafety/zodiac-evacuation-systems.
    (7) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (8) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on June 23, 2016.
Dorr M. Anderson,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-15902 Filed 7-7-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)]
[Notices]
[Pages 5776-5778]
[FR Doc No: 2018-02588]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-2390]

Determination of Regulatory Review Period for Purposes of Patent
Extension; STRENSIQ

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for STRENSIQ 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 the U.S. Patent and

Trademark Office (USPTO), Department of Commerce, for the extension of
a patent which claims that human biological product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
10, 2018. 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 August 8, 2018.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 10, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 10, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-E-2390 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; STRENSIQ.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 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 biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological 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 biological
product and continues until FDA grants permission to market the
biological product. Although only a portion of a regulatory review
period may count toward the actual amount of extension that the
Director of USPTO 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 biological product will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(1)(B).
    FDA has approved for marketing the human biologic product STRENSIQ
(asfotase alfa). STRENSIQ is indicated for the treatment of patients
with perinatal/infantile- and juvenile-onset hypophosphatasia.
Subsequent to this approval, the USPTO received a patent term
restoration application for STRENSIQ (U.S. Patent No. 7,763,712) from
Alexion Pharmaceuticals, Inc., and the USPTO requested FDA's assistance
in determining this patent's eligibility

for patent term restoration. In a letter dated August 31, 2016, FDA
advised the USPTO that this human biological product had undergone a
regulatory review period and that the approval of STRENSIQ represented
the first permitted commercial marketing or use of the product.
Thereafter, the USPTO requested that FDA determine the product's
regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
STRENSIQ is 2,670 days. Of this time, 2,365 days occurred during the
testing phase of the regulatory review period, while 305 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 (21 U.S.C. 355(i)) became effective: July 3,
2008. The applicant claims July 4, 2008, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was July 3, 2008,
which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): December 23, 2014. FDA has verified the
applicant's claim that the biologics license application (BLA) for
STRENSIQ (BLA 125513) was initially submitted on December 23, 2014.
    3. The date the application was approved: October 23, 2015. FDA has
verified the applicant's claim that BLA 125513 was approved on October
23, 2015.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,109 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (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.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: February 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02588 Filed 2-8-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 101 (Thursday, May 24, 2012)]
[Proposed Rules]
[Pages 30926-30928]
[FR Doc No: 2012-12414]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0217; Directorate Identifier 2009-NE-23-AD]
RIN 2120-AA64

Airworthiness Directives; Pratt & Whitney Division Turbofan
Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to supersede an existing airworthiness directive
(AD) that applies to all Pratt & Whitney Division (Pratt & Whitney)
PW4052, PW4056, PW4060, PW4062, PW4062A, PW4074, PW4077, PW4077D,
PW4084D, PW4090, PW4090-3, PW4152, PW4156A, PW4158, PW4164, PW4168,
PW4168A, PW4460, and PW4462 turbofan engines. The existing AD currently
requires initial and repetitive fluorescent penetrant inspections (FPI)
for cracks in the blade locking and loading slots of the high-pressure
compressor (HPC) drum rotor disk assembly rear drum. Since we issued
that AD, Pratt & Whitney has developed a redesigned HPC drum rotor disk
assembly for certain affected engine models. This proposed AD would
also require replacement of the 13th, 14th, and 15th stage HPC seals as
an additional action and would add an optional terminating action to
the repetitive inspection requirements by allowing replacement of the
entire HPC drum rotor disk assembly. We are proposing this AD to
prevent failure of the HPC drum rotor disk assembly, which could lead
to an uncontained engine failure, and damage to the airplane.

DATES: We must receive comments on this proposed AD by July 23, 2012.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Pratt &
Whitney, 400 Main St., East Hartford, CT 06108; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>. You may review copies of the referenced 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; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (phone:<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

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

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2010-0217;
Directorate Identifier 2009-NE-23-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    On August 26, 2010, we issued AD 2010-18-13, Amendment 39-16427 (75
FR 55459, September 13, 2010), for all Pratt & Whitney PW4052, PW4056,
PW4060, PW4062, PW4062A, PW4074, PW4077, PW4077D, PW4084D, PW4090,
PW4090-3, PW4152, PW4156A, PW4158, PW4164, PW4168, PW4168A, PW4460, and
PW4462 turbofan engines. That AD requires initial and repetitive FPI
for cracks in the blade locking and loading slots of the HPC rear drum.
That AD resulted from reports of cracked locking and loading slots in
the HPC rear drum. We issued that AD to prevent failure of the HPC drum
rotor disk assembly, which could lead to an uncontained engine failure,
and damage to the airplane.

Actions Since Existing AD Was Issued

    Since we issued AD 2010-18-13 (75 FR 55459, September 13, 2010),
Pratt & Whitney has developed a redesigned HPC drum rotor disk assembly
for PW4000-94'' and PW4000-100'' engine models. The redesign includes
new 13th, 14th, and 15th stage HPC seals that lower the temperature in
the loading and locking slots and decrease the likelihood of cracking.
Based on the risk analysis, it was determined that installing the
redesigned 13th, 14th, and 15th stage HPC seals on the original design
HPC drum rotor disk assembly is an additional required action to
maintain an acceptable level of safety and prevent cracking in the
loading and locking slots while the redesigned HPC drum rotor disk
assembly is being implemented. The option of installing a redesigned
HPC drum rotor disk assembly is considered final corrective action to
the repetitive inspections required by this AD.

Relevant Service Information

    Prior to publishing AD 2010-18-13 (75 FR 55459, September 13,
2010), we reviewed the technical contents of Pratt & Whitney Service
Bulletin (SB) No. PW4ENG 72-796, dated June 11, 2009, SB No. PW4G-100-
72-186, Revision 1, dated September 2, 2004, and SB No. PW4G-112-72-
264, Revision 2, dated February 23, 2010. Those three SBs describe
procedures for performing a local FPI of the HPC rear drum blade
locking and loading slots for cracks.
    During the development of this proposed AD, we reviewed Pratt &
Whitney SB No. PW4ENG 72-816, dated December 2, 2011, and SB No. PW4G-
100-72-240, dated November 15, 2011. Those two SBs describe procedures
for replacing the 13th, 14th, and 15th stage HPC seals in PW4000-94''
and PW4000-100'' engine models, with redesigned seals. We also reviewed
Pratt & Whitney SB No. PW4ENG 72-817, dated December 7, 2011, and SB
No. PW4G-100-72-241, dated November 15, 2011. Those two SBs describe
procedures for replacing the HPC drum rotor disk assemblies in PW4000-
94'' and PW4000-100'' engine models, with redesigned HPC drum rotor
disk assemblies.

FAA's Determination

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

Proposed AD Requirements

    This proposed AD would retain all of the requirements of AD 2010-
18-13 (75 FR 55459, September 13, 2010). This proposed AD would also
require replacement of the 13th, 14th, and 15th stage HPC seals with
redesigned seals, and would add an optional terminating action to the
repetitive inspection requirements by allowing replacement of the HPC
drum rotor disk assembly with a redesigned HPC drum rotor disk
assembly.

Costs of Compliance

    We estimate that this proposed AD would affect 911 engines
installed on airplanes of U.S. registry. We also estimate that it would
take about 1 work-hour per engine to perform an inspection using an
average labor rate of $85 per work-hour. We estimate that there are 770
PW4000-94'' and PW4000-100'' engines that would require replacement of
13th, 14th, and 15th stage HPC seals, at a parts cost of $3,000 per
engine. No additional labor is assumed when the replacement is done at
piece-part exposure of the HPC drum rotor disk assembly. The
replacement parts cost of the redesigned HPC drum rotor disk assembly
is $630,000. Based on these figures, we estimate that the total cost of
the proposed AD to U.S. operators will be $2,387,435.

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 have determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that the proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by removing airworthiness directive
(AD) 2010-18-13, Amendment 39-16427 (75 FR 55459, September 13, 2010),
and adding the following new AD:

Pratt & Whitney Division: Docket No. FAA-2010-0217; Directorate
Identifier 2009-NE-23-AD.

(a) Comments Due Date

    The FAA must receive comments on this AD action by July 23,
2012.

(b) Affected ADs

    This AD supersedes AD 2010-18-13, Amendment 39-16427 (75 FR
55459, September 13, 2010).

(c) Applicability

    This AD applies to the following Pratt & Whitney Division (Pratt
& Whitney) turbofan engines:
    (1) PW4000-94'' engine models PW4052, PW4056, PW4060, PW4062,
PW4062A, PW4152, PW4156A, PW4158, PW4460, and PW4462, including
those models with any dash number suffix, with a high-pressure
compressor (HPC) drum rotor disk assembly listed in Table 1 of this
AD.
    (2) PW4000-100'' engine models PW4164, PW4168, and PW4168A, with
a HPC drum rotor disk assembly listed in Table 1 of this AD.
    (3) PW4000-112'' engine models PW4074, PW4077, PW4077D, PW4084D,
PW4090, and PW4090-3, with a HPC drum rotor disk assembly listed in
Table 1 of this AD.

            Table 1--Affected HPC Drum Rotor Disk Assemblies
------------------------------------------------------------------------
                                 Affected HPC drum rotor disk assembly
        Engine models                         part numbers
------------------------------------------------------------------------
PW4000-94''..................  50H936; 50H936-002; 53H923-01; 53H923-
                                001; 53H973-01; 53H973-001; 54H803-01;
                                54H803-001; 54H803-002; 56H013-01;
                                56H013-001; 58H236-01.
PW4000-100''.................  53H973-01; 53H973-001; 54H803-01; 54H803-
                                001; 54H803-002; 56H013-01; 56H013-001;
                                58H236-01.
PW4000-112''.................  55H722-01; 55H410-01; 57H010-01; 57H210-
                                01; 57H610-01; 57H910-01.
------------------------------------------------------------------------

(d) Unsafe Condition

    This AD was prompted by Pratt & Whitney developing a redesigned
HPC drum rotor disk assembly for certain affected engine models. We
are issuing this AD to prevent failure of the HPC drum rotor disk
assembly, which could lead to an uncontained engine failure, and
damage to the airplane.

(e) Compliance

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

(f) Local Fluorescent Penetrant Inspection

    (1) Perform a local fluorescent penetrant inspection for cracks
in the HPC drum rotor disk assembly rear drum blade locking and
loading slots of the specific stages of the HPC drum rotor disk
assemblies from which any

of the blades are removed as specified in Table 2 of this AD.

                         Table 2--Compliance Times and Service Bulletins by Engine Model
----------------------------------------------------------------------------------------------------------------
           For engine model                   Inspect whenever--                    To inspect, use--
----------------------------------------------------------------------------------------------------------------
PW4074, PW4077, PW4077D, PW4084D,       Any of the HPC 13thor           Paragraphs 1.A. through 1.B. of the
 PW4090, and PW4090-3.                   14thstage blades are removed    Accomplishment Instructions of PW4G-112-
                                         during a shop visit.            72-264, Revision 2, dated February 23,
                                                                         2010.
PW4164, PW4168, and PW4168A...........  Any of the HPC 13th, 14th, or   Paragraphs 1.A. through 1.C of the
                                         15th stage blades are removed   Accomplishment Instructions of PW4G-100-
                                         during a shop visit.            72-186, Revision 1, dated September 2,
                                                                         2004.
PW4052, PW4056, PW4060, PW4062,         Any of the HPC 13th, 14th, or   Paragraphs 1.A. through 1.C. of the
 PW4062A, PW4152, PW4156A, PW4158,       15th stage blades are removed   Accomplishment Instructions of PW4ENG
 PW4460, and PW4462.                     during a shop visit.            72-796, dated June 11, 2009.
----------------------------------------------------------------------------------------------------------------

     (2) Remove from service any HPC drum rotor disk assembly rear
drum found with a crack in any of the blade loading and locking
slots.

(g) Replacement of 13th, 14th, and 15th HPC Seals

    At the next piece-part exposure of the HPC drum rotor disk
assembly after the effective date of this AD:
    (1) Replace the 13th, 14th, and 15th stage HPC seals of engines
listed in paragraph (c)(1) of this AD in accordance with the
Accomplishment Instructions of Pratt & Whitney Service Bulletin (SB)
No. PW4ENG 72-816, dated December 2, 2011.
    (2) Replace the 13th, 14th, and 15th stage HPC seals of engines
listed in paragraph (c)(2) of this AD in accordance with the
Accomplishment Instructions of Pratt & Whitney SB No. PW4G-100-72-
240, dated November 15, 2011.

(h) Optional Terminating Action

    As optional terminating action to the repetitive inspection
requirements of this AD:
    (1) Replace the HPC drum rotor disk assembly of engines listed
in paragraph (c)(1) of this AD with a redesigned HPC drum rotor disk
assembly in accordance with the Accomplishment Instructions of Pratt
& Whitney SB No. PW4ENG 72-817, dated December 7, 2011.
    (2) Replace the HPC drum rotor disk assembly of engines listed
in paragraph (c)(2) of this AD with a redesigned HPC drum rotor disk
assembly in accordance with the Accomplishment Instructions of Pratt
& Whitney SB No. PW4G-100-72-241, dated November 15, 2011.

(i) Definition

    For the purpose of this AD, piece-part exposure means that the
HPC drum rotor disk assembly is removed from the engine and
completely disassembled.

(j) Alternative Methods of Compliance (AMOCs)

    The Manager, Engine Certification Office, may approve AMOCs for
this AD. Use the procedures found in 14 CFR 39.19 to make your
request. AMOCs approved previously in accordance with AD 2010-18-13,
Amendment 39-16427 (75 FR 55459, September 13, 2010) are approved as
AMOCs for the corresponding requirements in paragraph (f) of this
AD.

(k) Related Information

    (1) For more information about this AD, contact James Gray,
Aerospace Engineer, Engine & Propeller Directorate, FAA, 12 New
England Executive Park, Burlington, MA 01803; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact Pratt
& Whitney, 400 Main St., East Hartford, CT 06108; phone: 860-565-
7700; fax:<PHONE_NUMBER>. You may review copies of the referenced
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>.

    Issued in Burlington, Massachusetts, on May 16, 2012.
Peter A. White,
Manager, Engine & Propeller Directorate, Aircraft Certification
Service.
[FR Doc. 2012-12414 Filed 5-23-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: December 22, 2008 (Volume 73, Number 246)]
[Notices]
[Page 78422-78424]
[DOCID:fr22de08-151]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-00-7918; FMCSA-00-8398; FMCSA-06-26066]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of renewal of exemptions; request for comments.

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

SUMMARY: FMCSA announces its decision to renew the exemptions from the
vision requirement in the Federal Motor Carrier Safety Regulations for
44 individuals. FMCSA has statutory

authority to exempt individuals from the vision requirement if the
exemptions granted will not compromise safety. The Agency has concluded
that granting these exemption renewals will provide a level of safety
that is equivalent to, or greater than, the level of safety maintained
without the exemptions for these commercial motor vehicle (CMV)
drivers.

DATES: This decision is effective January 9, 2009. Comments must be
received on or before January 21, 2009.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket ID FMCSA-00-7918; FMCSA-00-8398; FMCSA-
06-26066, using any of the following methods.
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m.
and 5 p.m., Monday through Friday, except Federal holidays.
     Fax: 1-202-493-2251.
    Each submission must include the Agency name and the docket number
for this Notice. Note that DOT posts all comments received without
change to http://www.regulations.gov, including any personal
information included in a comment. Please see the Privacy Act heading
below.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review the DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (65 FR 19476). This information is
also available at http://DocketInfo.dot.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Mary D. Gunnels, Director, Medical
Programs,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA, Department of
Transportation, 1200 New Jersey Avenue, SE., Room W64-224, Washington,
DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m. Monday through
Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may renew an exemption
from the vision requirements in 49 CFR 391.41(b)(10), which applies to
drivers of CMVs in interstate commerce, for a two-year period if it
finds ``such exemption would likely achieve a level of safety that is
equivalent to, or greater than, the level that would be achieved absent
such exemption.'' The procedures for requesting an exemption (including
renewals) are set out in 49 CFR part 381.

Exemption Decision

    This notice addresses 44 individuals who have requested a renewal
of their exemption in accordance with FMCSA procedures. FMCSA has
evaluated these 44 applications for renewal on their merits and decided
to extend each exemption for a renewable two-year period. They are:
Michael L. Allen
Felipe Bayron
Dennis M. Boggs
Roy L. Brown
David L. Cattoor
Roger E. Clark
Gary C. Cone
Cesar A. Cruz
Arthur Dolengewicz
Wayne A. Elkins, II
Bruce A. Walker
Leon C. Flynn
David G. Guldan
Larry W. Hancock
Guadalupe J. Hernandez
James L. Houser
Richard G. Isenhart
Ricky G. Jacks
Joe E. Jones
Damir Kocijan
Robert T. Lantry
John W. Laskey
Kenneth Liuzza
Samson B. Margison
Michael W. McClain
Terrence L. McKinney
Dennis N. McQuiston
Garth R. Mero
Ronald C. Morris
Kenneth E. Parrott
Charles R. Patten
Raymond E. Royer
Randal C. Schmude
Steven M. Scholfield
Dennis J. Smith
David C. Stitt
Kevin L. Truxell
Earl M. Vaughan
Bruce A. Walker
Harold R. Wallace
Lee A. Wiltjer
John H. Wisner
Theron L. Wood

    These exemptions are extended subject to the following conditions:
(1) That each individual have a physical examination every year (a) by
an ophthalmologist or optometrist who attests that the vision in the
better eye continues to meet the standard in 49 CFR 391.41(b)(10), and
(b) by a medical examiner who attests that the individual is otherwise
physically qualified under 49 CFR 391.41; (2) that each individual
provide a copy of the ophthalmologist's or optometrist's report to the
medical examiner at the time of the annual medical examination; and (3)
that each individual provide a copy of the annual medical certification
to the employer for retention in the driver's qualification file and
retain a copy of the certification on his/her person while driving for
presentation to a duly authorized Federal, State, or local enforcement
official. Each exemption will be valid for two years unless rescinded
earlier by FMCSA. The exemption will be rescinded if: (1) The person
fails to comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
before it was granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136(e) and
31315.

Basis for Renewing Exemptions

    Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no
longer than two years from its approval date and may be renewed upon
application for additional two year periods. In accordance with 49
U.S.C. 31136(e) and 31315, each of the 44 applicants has satisfied the
entry conditions for obtaining an exemption from the vision
requirements (65 FR 66286; 66 FR 13825; 65 FR 78256; 66 FR 1631; 71 FR
63379; 72 FR 1050). Each of these 44 applicants has requested renewal
of the exemption and has submitted evidence showing that the vision in
the better eye continues to meet the standard specified at 49 CFR
391.41(b)(10) and that the

vision impairment is stable. In addition, a review of each record of
safety while driving with the respective vision deficiencies over the
past two years indicates each applicant continues to meet the vision
exemption standards. These factors provide an adequate basis for
predicting each driver's ability to continue to drive safely in
interstate commerce. Therefore, FMCSA concludes that extending the
exemption for each renewal applicant for a period of two years is
likely to achieve a level of safety equal to that existing without the
exemption.

Request for Comments

    FMCSA will review comments received at any time concerning a
particular driver's safety record and determine if the continuation of
the exemption is consistent with the requirements at 49 U.S.C. 31136(e)
and 31315. However, FMCSA requests that interested parties with
specific data concerning the safety records of these drivers submit
comments by January 21, 2009.
    FMCSA believes that the requirements for a renewal of an exemption
under 49 U.S.C. 31136(e) and 31315 can be satisfied by initially
granting the renewal and then requesting and evaluating, if needed,
subsequent comments submitted by interested parties. As indicated
above, the Agency previously published notices of final disposition
announcing its decision to exempt these 44 individuals from the vision
requirement in 49 CFR 391.41(b)(10). The final decision to grant an
exemption to each of these individuals was based on the merits of each
case and only after careful consideration of the comments received to
its notices of applications. The notices of applications stated in
detail the qualifications, experience, and medical condition of each
applicant for an exemption from the vision requirements. That
information is available by consulting the above cited Federal Register
publications.
    Interested parties or organizations possessing information that
would otherwise show that any, or all of these drivers, are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is being compromised or if continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315, FMCSA will take immediate steps to revoke the
exemption of a driver.

    Issued on: December 12, 2008.
Larry W. Minor,
Associate Administrator for Policy and Program Development.
 [FR Doc. E8-30389 Filed 12-19-08; 8:45 am]

BILLING CODE 4910-EX-P