MEMORANDUM

DATE:08/14/2014
FROM: 		Laura Farris/EPA Region 8
TO:CLEAN Power Plan for Existing Power Plants; Docket Id: OAR - 2013-0602
SUBJECT:	American Lung Association Luncheon held on 08/14/2014

SUMMARY:

Carl Daly, EPA Region 8 Air Program Director, attended an American Lung Association Luncheon featuring Dr. Jonathan Buonocore from Harvard University School of Public Health, who spoke about their recent study on the co-benefits of reducing carbon pollution. Mr. Daly encouraged attendees to submit comments to the Clean Power Plan docket. This Plan was proposed on June 2, 2014.
ATTENDEES:
EPA REGION 8:
CARL DALY, AIR PROGRAM DIRECTOR
OTHER GUESTS:
JONATHAN Buonocore, the Harvard Researcher
   * Cindy, Liverance, ALA-Colorado
   * Christian Stumpf, ALA-Southwest region Director of Public Policy
   * John Streit, RT, ALA-Colorado
   * Sandy Stenmark, Kaiser
   * Michelle Irwin, Channel 7
   * Rohit Katial, MD, National Jewish Health
   * Dale Varner, MD, Kaiser
   * Beth Chacon, Xcel
   * Rob Mansheim, International Association for the Study of Lung Cancer
   * Natalia Swalnick, BCS, Incorporated
   * Justin Wilson, Western Conversation Foundation
   * Frank Swain, Colorado Conservation
   * Ivor Douglas, MD, American Thoracic Society
   * Cindy Bosco, Denver Mayor's Office
   * Tyler Svitak, Clean Cities Coalition
   * Tom Schuck, Southern Region Clean Cities Coalition
   * Steve McCannon, Regional Air Quality Council
   * Julie Moyle, Healthier Hospitals Initiative

DOCUMENTS EXCHANGED:
Copy of May 27, 2014, paper: Co-Benefits of Carbon Standards, which can be found here:
http://eng-cs.syr.edu/our-departments/civil-and-environmental-engineering/research/carbon-co-benefits-research/


[Federal Register Volume 79, Number 208 (Tuesday, October 28, 2014)]
[Rules and Regulations]
[Pages 64114-64117]
[FR Doc No: 2014-25588]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, and 556

[Docket No. FDA-2014-N-0002]

New Animal Drugs; Alfaxalone; Dinoprost; Ivermectin and
Clorsulon; Nitrofurazone; Trenbolone and Estradiol Benzoate;
Trimethoprim and Sulfadiazine; Tylosin; Change of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule, technical amendment.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval actions for new animal drug
applications (NADAs) and abbreviated new animal drug applications
(ANADAs) during August 2014. FDA is also informing the public of the
availability of summaries of the basis of approval and of environmental
review documents, where applicable. The animal drug regulations are
also being amended to reflect a change of sponsorship of two NADAs and
one ANADA, and to reflect a revised food safety warning.

DATES: This rule is effective October 28, 2014.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations
to reflect approval actions for NADAs and ANADAs during August 2014, as
listed in table 1. In addition, FDA is informing the public of the
availability, where applicable, of documentation of environmental
review required under the National Environmental Policy Act (NEPA) and,
for actions requiring review of safety or effectiveness data, summaries
of the basis of approval (FOI Summaries) under the Freedom of
Information Act (FOIA). These public documents may be seen in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4
p.m., Monday through Friday. Persons with access to the Internet may
obtain these documents at the CVM FOIA Electronic Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing exclusivity and
patent information may be accessed in FDA's publication, Approved
Animal Drug Products Online (Green Book) at: http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.
    In addition, Macleod Pharmaceuticals, Inc., 2600 Canton Ct., Fort
Collins, CO 80525 has transferred ownership of, and all rights and
interest in ANADA 200-033 for UNIPRIM (trimethoprim and sulfadiazine)
Powder to Neogen Corp. (Neogen), 944 Nandino Blvd., Lexington, KY
40511. In 2004, Hess & Clark, Inc., transferred ownership of, and all
rights and interest in NADA 011-154 for NFZ Puffer (nitrofurazone
soluble powder) and NADA 140-851 for NFZ Wound Dressing (nitrofurazone
ointment) to Neogen. At this time, the regulations are being amended to
reflect these transfers.
    Following these changes of sponsorship, Macleod Pharmaceuticals,
Inc., and Hess & Clark, Inc., will no longer be the sponsor of an
approved application. Accordingly, 21 CFR 510.600(c) is being amended
to remove the entries for these firms.
    Also, the animal drug regulations are being amended in 21 CFR
522.690 to revise a human food safety warning for dinoprost
tromethamine injectable solution. This amendment is being made to
improve the accuracy of the regulations.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

                                     Table 1--Original and Supplemental NADAs and ANADAs Approved During August 2014
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                              New animal drug
    NADA/ANADA             Sponsor              product name              Action           21 CFR  Sections        FOIA  Summary         NEPA Review
--------------------------------------------------------------------------------------------------------------------------------------------------------
140-833...........  Merial Ltd., 3239      IVOMEC Plus            Supplemental approval  522.1193............  yes.................  CE.1 2
                     Satellite Blvd.,       (ivermectin and        reducing the          556.344.............
                     Bldg. 500, Duluth,     clorsulon) Injection   preslaughter
                     GA 30096-4640.         for Cattle.            withdrawal period
                                                                   from 49 days to 21
                                                                   days.
141-043...........  Zoetis Inc., 333       SYNOVEX CHOICE         Supplemental approval  522.2478............  yes.................  EA/FONSI.\3\
                     Portage St.,           (trenbolone and        for increased rate
                     Kalamazoo, MI 49007.   estradiol implant).    of weight gain and
                                                                   improved feed
                                                                   efficiency in
                                                                   heifers fed in
                                                                   confinement for
                                                                   slaughter.
141-342...........  Jurox Pty. Ltd., 85    ALFAXAN (alfaxalone)   Supplemental approval  522.52..............  no..................  CE.1 4
                     Gardiner Rd.,          Injectable             adding a label
                     Rutherford, NSW        Anesthetic for Dogs    statement that
                     2320, Australia.       and Cats.              alfaxalone is a
                                                                   Class IV controlled
                                                                   substance.

141-348...........  Zoetis Inc., 333       SYNOVEX ONE FEEDLOT    Original approval for  522.2478............  yes.................  EA/FONSI.1 3
                     Portage St.,           (trenbolone and        increased rate of
                     Kalamazoo, MI 49007.   estradiol extended     weight gain and
                                            release implant).      improved feed
                                           SYNOVEX ONE GRASS       efficiency for up to
                                            (trenbolone and        200 days in steers
                                            estradiol extended     and heifers fed in
                                            release implant).      confinement for
                                                                   slaughter.
                                                                  Original approval for
                                                                   increased rate of
                                                                   weight gain for up
                                                                   to 200 days in
                                                                   pasture steers and
                                                                   heifers (slaughter,
                                                                   stocker, and feeder).
200-455 \5\.......  Cross Vetpharm Group   TYLOMED-WS (tylosin    Supplemental approval  520.2640............  no..................  CE.1 6
                     Ltd. Broomhill Rd.,    tartrate) Soluble      of a change to
                     Tallaght,.             Powder.                veterinary
                    Dublin 24, Ireland...                          prescription (Rx)
                                                                   marketing status to
                                                                   conform with
                                                                   reference (pioneer)
                                                                   product.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The Agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the requirement to submit an environmental
  assessment or an environmental impact statement because it is of a type that does not individually or cumulatively have a significant effect on the
  human environment.
\2\ CE granted under 21 CFR 25.33(a).
\3\ The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a finding of
  no significant impact (FONSI).
\4\ CE granted under 21 CFR 25.33(d)(1).
\5\ This application was listed as being affected by guidance for industry (GFI) #213, ``New Animal Drugs and New Animal Drug Combination Products
  Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product
  Use Conditions with GFI #209'', December 2013.
\6\ CE granted under 21 CFR 25.33(a)(1).

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.

21 CFR Parts 520, 522, and 524

    Animal drugs.

21 CFR Part 556

    Animal drugs, Foods.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510,
520, 522, 524, and 556 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

0
2. In Sec.  510.600, in the table in paragraph (c)(1), remove the
entries for ``Macleod Pharmaceuticals, Inc.'' and ``Hess & Clark,
Inc.'' and alphabetically add an entry for ``Neogen Corp.''; and in the
table in paragraph (c)(2), remove the entries for ``058711'' and
``050749'' and numerically add an entry for ``059051'' to read as
follows:

Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------

                              * * * * * * *
Neogen Corp., 944 Nandino Blvd., Lexington, KY 40511....          059051

                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
 Drug labeler
     code                         Firm name and address
------------------------------------------------------------------------

                              * * * * * * *
        059051  Neogen Corp., 944 Nandino Blvd., Lexington, KY 40511

                              * * * * * * *
------------------------------------------------------------------------

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 520 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

Sec.  520.2613  [Amended]

0
4. In paragraph (b) of Sec.  520.2613, remove ``058711'' and in its
place add ``059051''.
0
5. In Sec.  520.2640, revise paragraphs (b), (d), and (e)(2)(ii) to
read as follows:

Sec.  520.2640  Tylosin.

* * * * *
    (b) Sponsors--(1) No. 000986 for use as in paragraph (e) of this
section.
    (2) Nos. 016592 and 061623 for use as in paragraphs (e)(1)(i)(A),
(e)(1)(ii), (e)(2), (e)(3), and (e)(4) of this section.
* * * * *
    (d) Special considerations. Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
    (e) * * *
    (2) * * *
    (ii) Indications for use. For the reduction in severity of effects
of infectious sinusitis associated with Mycoplasma gallisepticum.
* * * * *

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
6. The authority citation for 21 CFR part 522 continues to read as
follows:

    Authority: 21 U.S.C. 360b.
0
7. In Sec.  522.52, in paragraph (c)(3), add a second sentence to read
as follows:

Sec.  522.52  Alfaxalone.

* * * * *
    (c) * * *
    (3) * * * Alfaxalone is a Class IV controlled substance.

0
8. In Sec.  522.690, revise paragraph (d)(1)(iii) to read as follows:

Sec.  522.690  Dinoprost.

* * * * *
    (d) * * *
    (1) * * *
    (iii) Limitations. Do not use in horses intended for human
consumption.
* * * * *

0
9. In Sec.  522.1193, revise paragraph (e)(3) to read as follows:

Sec.  522.1193  Ivermectin and clorsulon.

* * * * *
    (e) * * *
    (3) Limitations. For No. 050604: Do not treat cattle within 21 days
of slaughter. For Nos. 055529 and 058005: Do not treat cattle within 49
days of slaughter. Because a withdrawal time in milk has not been
established, do not use in female dairy cattle of breeding age. A
withdrawal period has not been established for preruminating calves. Do
not use in calves to be processed for veal.

0
10. In Sec.  522.2478, revise paragraphs (a), (d)(1)(i) introductory
text, (d)(1)(ii) introductory text, and (d)(2); and add paragraphs
(d)(1)(iii) and (d)(3) to read as follows:

Sec.  522.2478  Trenbolone acetate and estradiol benzoate.

    (a) Specifications--(1) Each implant consists of:
    (i) 8 pellets, each pellet containing 25 milligrams (mg) trenbolone
acetate and 3.5 mg estradiol benzoate.
    (ii) 4 pellets, each pellet containing 25 mg trenbolone acetate and
3.5 mg estradiol benzoate.
    (2) Each extended release implant consists of:
    (i) 8 pellets with a porous polymer film coating, each pellet
containing 25 mg trenbolone acetate and 3.5 mg estradiol benzoate.
    (ii) 6 pellets with a porous polymer film coating, each pellet
containing 25 mg trenbolone acetate and 3.5 mg estradiol benzoate.
* * * * *
    (d) * * *
    (1) * * *
    (i) For an implant as described in paragraph (a)(1)(i) of this
section:
* * * * *
    (ii) For an implant as described in paragraph (a)(1)(ii) of this
section:
* * * * *
    (iii) For an implant as described in paragraph (a)(2)(i) of this
section:
    (A) Amount. 200 mg trenbolone acetate and 28 mg estradiol benzoate
in an extended release implant.
    (B) Indications for use. For increased rate of weight gain and
improved feed efficiency for up to 200 days.
    (C) Limitations. Implant subcutaneously in ear only. Safety and
effectiveness have not been established in veal calves. A withdrawal
period has not been established for this product in preruminating
calves. Do not use in calves to be processed for veal.
    (2) Heifers fed in confinement for slaughter--(i) For an implant as
described in paragraph (a)(1)(i) of this section:
    (A) Amount. 200 mg trenbolone acetate and 28 mg estradiol benzoate.
    (B) Indications for use. For increased rate of weight gain.
    (C) Limitations. Implant subcutaneously in ear only. Not for use in
dairy or beef replacement heifers. Safety and effectiveness have not
been established in veal calves. A withdrawal period has not been
established for this product in preruminating calves. Do not use in
calves to be processed for veal.
    (ii) For an implant as described in paragraph (a)(1)(ii) of this
section:
    (A) Amount. 100 mg trenbolone acetate and 14 mg estradiol benzoate.
    (B) Indications for use. For increased rate of weight gain and
improved feed efficiency.
    (C) Limitations. Implant subcutaneously in ear only. Not for use in
dairy or beef replacement heifers. Safety and effectiveness have not
been established in veal calves. A withdrawal period has not been
established for this product in preruminating calves. Do not use in
calves to be processed for veal.
    (iii) For an implant as described in paragraph (a)(2)(i) of this
section:
    (A) Amount. 200 mg trenbolone acetate and 28 mg estradiol benzoate
in an extended release implant.
    (B) Indications for use. For increased rate of weight gain and
improved feed efficiency for up to 200 days.
    (C) Limitations. Implant subcutaneously in ear only. Not for use in
dairy or beef replacement heifers. Safety and effectiveness have not
been established in veal calves. A withdrawal period has not been
established for this product in preruminating calves. Do not use in
calves to be processed for veal.
    (3) Pasture steers and heifers (slaughter, stocker, and feeder)--
(i) For an implant as described in paragraph (a)(2)(ii) of this
section:
    (A) Amount. 150 mg trenbolone acetate and 21 mg estradiol benzoate
in an extended release implant.
    (B) Indications for use. For increased rate of weight gain for up
to 200 days.
    (C) Limitations. Implant subcutaneously in ear only. Not for use in
dairy or beef replacement heifers.

Safety and effectiveness have not been established in veal calves. A
withdrawal period has not been established for this product in
preruminating calves. Do not use in calves to be processed for veal.
    (ii) [Reserved]

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
11. The authority citation for 21 CFR part 524 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

Sec.  524.1580a  [Amended]

0
12. In paragraph (b)(1) of Sec.  524.1580a, remove ``Nos. 050749,
054628, 054925, 058005, and 061623'' and add in its place ``Nos.
054628, 054925, 058005, 059051, and 061623''.

Sec.  524.1580b  [Amended]

0
13. In paragraph (b) of Sec.  524.1580b, remove ``No. 054628'' and in
its place add ``Nos. 054628 and 059051''.

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

0
14. The authority citation for 21 CFR part 556 continues to read as
follows:

    Authority: 21 U.S.C. 342, 360b, 371.

0
15. In Sec.  556.344, revise paragraphs (a), (b)(1)(i), and (b)(2)(ii);
and add paragraph (c) to read as follows:

Sec.  556.344  Ivermectin.

    (a) Acceptable Daily Intake (ADI). The ADI for total residues of
ivermectin is 5 micrograms per kilogram of body weight per day.
    (b) * * *
    (1) * * *
    (i) Cattle. 1.6 parts per million.
    (2) * * *
    (ii) Cattle. 650 parts per billion.
    (c) Related conditions of use. See Sec. Sec.  520.1192, 520.1195,
520.1197, 522.1192, 522.1193, 524.1193, and 558.300 of this chapter.

    Dated: October 23, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-25588 Filed 10-27-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 25 (Wednesday, February 6, 2013)]
[Notices]
[Pages 8543-8544]
[FR Doc No: 2013-02613]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0536]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Device User
Fee Cover Sheet, Form FDA 3601

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by March
8, 2013.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0511.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Medical Device User Fee Cover Sheet, Form FDA 3601--(OMB Control Number
0910-0511)--Extension

    The Federal Food, Drug, and Cosmetic Act, as amended by the Medical
Device User Fee and Modernization Act of 2002 (MDUFMA) (Pub. L. 107-
250), and the Medical Device User Fee Amendments of 2007 (Title II of
the Food and Drug Administration Amendments Act of 2007), authorizes
FDA to collect user fees for certain medical device applications. Under
this authority, companies pay a fee for certain new medical device
applications or supplements submitted to the Agency for review. Because
the submission of user fees concurrently with applications and
supplements is required, the review of an application cannot begin
until the fee is submitted. Form FDA 3601, the ``Medical Device User
Fee Cover Sheet,'' is designed to provide the minimum necessary
information to determine whether a fee is required for review of an
application, to determine the amount of the fee required, and to
account for and track user fees. The form provides a cross-reference
between the fees submitted for an application with the actual submitted
application by using a unique number tracking system. The information
collected is used by FDA's Center for Devices and Radiological Health
and the Center for Biologics Evaluation and Research to initiate the
administrative screening of new medical device applications and
supplemental applications.
    The total number of annual responses is based on the number of
cover sheet submissions received by FDA in fiscal years 2009 through
2011. FDA received cover sheets for the following medical device
submissions (average annual): 38 premarket approval applications
(premarket approval application (PMA), product development protocol
(PDP), postmarketng requirement (PMR), biologics license application
(BLA)), 3,561 premarket notifications, 12 panel track supplements, 180
real-time supplements, 127 180-day supplements, 749 30-day notices, 84
513(g) requests, and 463 annual fees for periodic reporting. The number
of received annual responses included the cover sheets for applications
that were qualified for small businesses and fee waivers or reductions.
The estimated hours per response are based on past FDA experience with
the various cover sheet submissions, and range from 5 to 30 minutes.
The hours per response are based on the average of these estimates (18
minutes).
    In the Federal Register of June 6, 2012 (77 FR 33469), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one PRA related comment.
    The comment states that the cover sheet ``can be obtained prior to
payment of the fee and should not be available until payment of the fee
has been confirmed.'' It is unclear whether the comment addresses the
topics on which the 60-day notice invited comment. As stated earlier in
this document, the User Fee Cover Sheet is designed to provide the
minimum necessary information to determine whether a fee is required
for review of an application, to determine the amount of the fee
required, and to

account for and track user fees. MDUFMA requires the submission of the
user fees concurrently with applications (21 U.S.C. 379j(a)(2)(C)). If
the required fees are not submitted, the review of the application will
not begin. The User Fee Cover Sheet provides the information necessary
to either initiate or defer the application review.
    FDA estimates the burden of this collection of information as
follows:

                                   Table 1--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                      No. of                          Average
          Form FDA No.                No. of       Responses per   Total Annual     Burden per      Total Hours
                                    Respondents     Respondent       Responses       Response
----------------------------------------------------------------------------------------------------------------
3601............................           5,214               1           5,214            0.30           1,564
----------------------------------------------------------------------------------------------------------------

    Dated: February 1, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-02613 Filed 2-5-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 83, Number 85 (Wednesday, May 2, 2018)]
[Notices]
[Page 19367]
[FR Doc No: 2018-09264]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83119; File No. SR-ISE-2018-16]

Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of
Designation of Longer Period for Commission Action on Proposed Rule
Change To Introduce the ATR Protection for Orders that are Routed to
Away Markets

April 26, 2018.
    On February 23, 2018, Nasdaq ISE, LLC (``Exchange'') filed with the
Securities and Exchange Commission (``Commission''), pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder,\2\ a proposed rule change to amend Exchange
Rule 714 regarding the Acceptable Trade Range protection for orders and
quotes. The proposed rule change was published for comment in the
Federal Register on March 14, 2018.\3\ On April 20, 2018, the Exchange
submitted Amendment No. 1 to the proposed rule change.\4\ The
Commission received no comments on the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 82846 (March 9,
2018), 83 FR 11254 (``Notice'').
    \4\ See Letter to Brent J. Fields, Secretary, Commission, from
Adrian Griffiths, Senior Associate General Counsel, Nasdaq, Inc.,
dated April 20, 2018. Amendment No. 1 revises the proposed rule
change to: (i) Provide further discussion of the current application
of the ATR to orders routed away; (ii) modify the proposed rule text
regarding the recalculation of the ATR for orders routed away
pursuant to Supplementary Material to Exchange Rule 1901, if the
applicable National Best Bid or the National Best Offer price is
improved at the time of routing; (iii) expand the discussion and
justification for recalculating the ATR for such orders; and (iv)
make other amendments to the proposed rule text to improve the
understandability of the current ATR calculation. Amendment No. 1 is
available at: https://www.sec.gov/comments/sr-ise-2018-16/ise201816-3483594-162248.pdf.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \5\ provides that within 45 days of the
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether these proposed rule changes should be disapproved.
The 45th day for this filing is April 28, 2018.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission is extending the 45-day time period for Commission
action on the proposed rule change. The Commission finds that it is
appropriate to designate a longer period within which to take action on
the proposed rule change so that it has sufficient time to consider and
take action on the Exchange's proposed rule change.
    Accordingly, pursuant to Section 19(b)(2)(A)(ii)(I) of the Act \6\
and for the reasons stated above, the Commission designates June 12,
2018 as the date by which the Commission should either approve or
disapprove, or institute proceedings to determine whether to
disapprove, the proposed rule change (File No. SR-ISE-2018-16).
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(2)(A)(ii)(I).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(31).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-09264 Filed 5-1-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 148 (Wednesday, August 1, 2012)]
[Proposed Rules]
[Pages 45518-45520]
[FR Doc No: 2012-18622]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0727; Directorate Identifier 2012-NM-012-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain The Boeing Company Model DC-9-81 (MD-81), DC-9-82 (MD-82), DC-
9-83 (MD-83), DC-9-87 (MD-87), and MD-88 airplanes. This proposed AD
was prompted by reports of fatigue cracks found in Stringer 11 at the
outboard flap, inboard drive hinge at Station Xrs=164.000. This
proposed AD would require repetitive inspections for cracks in Stringer
11, and a splice repair if necessary; and repetitive post-repair
inspections, and repair if necessary. We are proposing this AD to
detect and correct such cracking, which could result in the wing
structure not supporting the limit load condition, which could lead to
loss of structural integrity of the wing.

DATES: We must receive comments on this proposed AD by September 17,
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 proposed AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
3855 Lakewood Boulevard, MC D800-0019, Long Beach, California 90846-
0001; telephone<PHONE_NUMBER>, extension 2; fax<PHONE_NUMBER>; Internet
https://www.myboeingfleet.com. You may review copies of the referenced
service information at the FAA, Transport Airplane Directorate, 1601
Lind Avenue SW., Renton, Washington. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

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: Roger Durbin, Airframe Branch, ANM-
120L, FAA, Los Angeles Aircraft Certification Office (ACO), 3960
Paramount Boulevard, Lakewood, California 90712-4137; phone: (562) 627-
5233; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2012-0727;
Directorate Identifier 2012-NM-012-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

    We received reports of fatigue cracks found in Stringer 11 at the
outboard flap, inboard drive hinge at Station Xrs=164.000. The cracking
occurred at the end fastener of the wing bulkhead clip attachment to
the stringer. If undetected, a crack in the stringer may grow until the
stringer severs, initiating a crack in the wing lower skin. This
condition, if not corrected, could result in the wing structure not
supporting the limit load condition, which could lead to loss of the
structural integrity of the wing.

Relevant Service Information

    We reviewed Boeing Alert Service Bulletin MD80-57A243, dated
December 20, 2011. The service information describes procedures for
repetitive in-tank eddy current high frequency (ETHF) inspections for
cracks in Stringer 11 at the outboard flap, inboard drive hinge at
Station Xrs=164.000, and a splice repair if necessary; and repetitive
post-repair inspections, and repair if necessary.

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 these same type
designs.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in the service information described previously, except as discussed
under ``Differences Between the Proposed AD and the Service
Information.''

Differences Between the Proposed AD and the Service Information

    The service bulletin specifies to contact the manufacturer for
instructions on how to repair certain conditions, but this proposed AD
would require repairing those conditions in one of the following ways:
     In accordance with a method that we approve; or
     Using data that meet the certification basis of the
airplane, and that have been approved by the Boeing Commercial
Airplanes Organization Designation Authorization (ODA) whom we have
authorized to make those findings.

Costs of Compliance

    We estimate that this proposed AD affects 502 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
              Action                    Labor cost         Parts cost     Cost per product        operators
----------------------------------------------------------------------------------------------------------------
Inspection.......................  13 work-hours x $85   None.........  $1,105 per           $554,710 per
                                    per hour = $1,105                    inspection cycle.    inspection cycle.
                                    per inspection
                                    cycle.
Post-repair inspection...........  13 work-hours x $85   None.........  1,105..............  554,710
                                    per hour = $1,105.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary repairs that
would be required based on the results of the proposed inspection. We
have no way of determining the number of aircraft that might need this
repair:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                 Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Splice repair per wing........................  93 work-hours x $85 per hour =           $17,759         $25,664
                                                 $7,905.
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions of the post-repair
inspection specified in this proposed AD.

Authority for This Rulemaking

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

Regulatory Findings

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

The Boeing Company: Docket No. FAA-2012-0727; Directorate Identifier
2012-NM-012-AD.

(a) Comments Due Date

    We must receive comments by September 17, 2012.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model DC-9-81 (MD-81), DC-
9-82 (MD-82), DC-9-83 (MD-83), and DC-9-87 (MD-87), and MD-88
airplanes, certificated in any category, as identified in Boeing
Alert Service Bulletin MD80-57A243, dated December 20, 2011.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 57, Wings.

(e) Unsafe Condition

    This AD was prompted by reports of fatigue cracks found in
Stringer 11 at the outboard flap, inboard drive hinge at Station
Xrs=164.000. We are issuing this AD to detect and correct such
cracking, which could result in the wing structure not supporting
the limit load condition, which could lead to loss of structural
integrity of the wing.

(f) Compliance

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

(g) Repetitive Inspections

    Before the accumulation of 19,000 total flight cycles, or within
8,710 flight cycles after the effective date of this AD, whichever
occurs later: Do an in-tank eddy current high frequency (ETHF)
inspection for cracks in Stringer 11 at the outboard flap, inboard
drive hinge at Station Xrs=164.000, in accordance with the
Accomplishment Instructions of Boeing Alert Service Bulletin MD80-
57A243, dated December 20, 2011. If no cracking is found, repeat the
inspection thereafter at intervals not to exceed 29,000 flight
cycles.

(h) Splice Repair

    If any cracking is found during the inspection required by
paragraph (g) of this AD: Before further flight, do a splice repair,
in accordance with the Accomplishment Instructions of Boeing Alert
Service Bulletin MD80-57A243, dated December 20, 2011.

(i) Post-Repair Inspection

    Within 60,000 flight cycles after doing the splice repair
specified in paragraph (h) of this AD: Do an ETHF inspection for
cracks in Stringer 11 at the outboard flap, inboard drive hinge at
Station Xrs=164.000, in accordance with the Accomplishment
Instructions of Boeing Alert Service Bulletin MD80-57A243, dated
December 20, 2011. Repeat the inspection thereafter at intervals

not to exceed 29,000 flight cycles. If any crack is found: Before
further flight, repair the crack using a method approved in
accordance with the procedures specified in paragraph (j) of this
AD.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles Aircraft Certification Office
(ACO), FAA, has the authority to approve AMOCs for this AD, if
requested using the procedures found in 14 CFR 39.19. In accordance
with 14 CFR 39.19, send your request to your principal inspector or
local Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in the Related Information
section of this AD.
    (2) 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.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by The
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Los Angeles ACO to
make those findings. For a repair method to be approved, the repair
must meet the certification basis of the airplane, and 14 CFR
25.571, Amendment 45, and the approval must specifically refer to
this AD.

(k) Related Information

    (1) For more information about this AD, contact Roger Durbin,
Airframe Branch, ANM-120L, FAA, Los Angeles Aircraft Certification
Office (ACO), 3960 Paramount Boulevard, Lakewood, California 90712-
4137; phone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
3855 Lakewood Boulevard, MC D800-0019, Long Beach, California 90846-
0001; telephone<PHONE_NUMBER>, extension 2; fax<PHONE_NUMBER>;
Internet https://www.myboeingfleet.com. You may review copies of the
referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue SW., Renton, Washington. For
information on the availability of this material at the FAA, call
425-227-1221.

    Issued in Renton, Washington on July 23, 2012.
Kalene C. Yanamura,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-18622 Filed 7-31-12; 8:45 am]
BILLING CODE 4910-13-P


2007 NAAQS for Ozone RIA

Federal Highway Administration

Received 6/13/07

                    Chapter 2, page 1, second paragraph under “2.1
Ozone Chemistry,” next to last sentence.  “In urban areas with a
high population concentration, ozone is often VOC-limited due to the
high density of traffic with NOx emissions.”  What is the basis for
this statement?  Many inventories also show a high percentage of NOx
emissions from other sources such as off-road engines and power plants,
especially in the future.
†撓敵琠桴楨桧搠湥楳祴漠牴晡楦楷桴丠硏攠
業獳潩獮ₔ桳畯摬戠敤敬整⹤

                    Chapter 2, page 2, first paragraph.  “and at X
latitude.”  What does “X” stand for?  How does this relate to the
previous sentence that states that the effect of latitude is strongest
in the winter?

                    Chapter 2, page 3, first paragraph.  “Solvent
use and highway vehicles are the two main sources of VOCs, with roughly
equal contributions to total emissions.   Emissions of VOCs from highway
vechicles account for roughly two-thirds of the transportation-related
emissions.”  Why is this placing such a strong emphasis on highway
vehicles, which were only 27% of emissions nonanthropogenic emissions in
2002.  Industrial processes were greater at 46%.  The list of sources of
VOC emissions should be complete and subjective terms should not be
used, and the year of data should be cited.  Instead a data driven
description should be given such as “in 2002, solvents were XX% of VOC
emissions, on-road vehicles were XX%, nonroad vehicles were XX%.”

                    Chapter 2, page 3, second paragraph.  “The two
largest sources of NOx are electric power generation plants and motor
vehicles.  Emissions of NOx therefore are highest in areas having a high
density of power plants and in urban regions having high traffic
density.  Once again, why is this placing such a strong emphasis on
highway vehicles?  What is the basis for this statement?  In 2002,
nonroad vehicles were 20% of emissions.   The list of sources of NOx
emissions should be complete and subjective terms should not be used,
and the year of data should be cited.  Instead a data driven description
should be given such as “in 2002, solvents were XX% of VOC emissions,
on-road vehicles were XX%, nonroad vehicles were XX%.”

                    Chapter 3, page 2, first paragraph under “3.1
Establishing the Baseline.”  “However, in developing the baseline it
was important to recognize that there are several areas that are not
required to meet the current standard by 2020.”  This is not correct.
Currently, only the South Coast area in California has a maximum
attainment date past 2020.  If this is the only area, then terms such as
“several” and “some” should not be used in this section.  If
this section is anticipating that areas will be bumped-up to higher
classifications, then this should be discussed, or the discussion in
Chapter 4, pages 8-9 for the two California areas referenced.  However,
this should also be consistent with Chapter 4, page 8, second paragraph
which states “The analysis assumes that all but one
Californ慩愠敲楷汬洠敥⁴桴畣牲湥⁴瑳湡慤摲⠠晥
敦瑣癩汥⁹⸰㠰‴灰⥭戠⁹〲〲鐮

                    Chapter 3, page 3, table 3.1.  It is recommended
that this table be divided to differentiate between national rules and
the less certain strategies presented in the PM NAAQS RIA.  We have
expressed several concerns regarding the strategies in the PM RIA, and
those strategies should be clearly separated from national rules both in
the title of the table(s) and in the body.

                    Chapter 3, page 7, first paragraph.  This
paragraph details that on-road controls are assumed to be applied
statewide for several states.  Is this reasonable to assume?  In
addition, it assumes a 75% penetration for diesel retrofits and idling
elimination in California, and a 25% penetration elsewhere.  What is the
basis for this assumption?  How is this reasonable, especially in
California?

                    Chapter 3, page 11, first paragraph.  “The
baseline predicted that 10 counties would not meet the current ozone
standard in 2020, even after inclusion of all known controls.”  As
currently designated and classified, all counties except for the 4 in
the South Coast are supposed to demonstrate attainment by at the latest
2013.  How do these counties relate to current classifications and SIPs
for the current standard that are due by June 15, 2007?  Are any of
these 10 counties in areas with submitted SIPs that show attainment
prior to 2020?

                     Chapter 3, page13, Table 3.4.  This table
details increased penetration of on-road SCR and DPF from 25% to 75%,
and continuous Inspection and Maintenance (OBD).  What is the basis for
these assumptions?  How are they reasonable?

                    Chapter 3, pages 21-23.  What are the time frames
(years) of these reductions?

¼

¾

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 nonroad rules, and the residual tons.

                    Chapter 5, page 4, section <IP_ADDRESS>.  “Cost
information for mobile source controls was taken from studies conducted
by EPA…”  These studies should be specifically referenced and cited.
 Also, it appears that “Appendix 6?” should be “Appendix 5.”

                    Chapter 6, incomplete.  This Chapter,
“Incremental Benefits of Attaining Alternative Ozone Standards
Relative to the Current 8-hour Standard,” is missing.

                    Chapter 8, incomplete.  “This chapter will
explain the results and the limitations of the analysis.”  However,
only four tables and no text are included.

                    Chapter 9.  This file is titled Chapter 9, but
the text is titled and numbered as Chapter 8.  The outline for the RIA
shows that the “Statutory and Executive Order Impact Analyses” are
Chapter 9.

                    Appendix 3, page 11, section 3.2.1, second
paragraph.  States, “We looked at options of applying this measure to
50% and 100% of the fleet…”  However, this does not seem to be
consistent with Chapter 3, which discusses 25% and 75% market
penetration.

                    Appendix 3, page 12, last paragraph.  Where are
the “interviews with component manufacturers” documented?  There
should be a specific reference to which manufacturers were interviewed,
when, and the topic of discussion.

                    Appendix 5, pages 4-5.  There seems to be a fault
in the logic applied in the development of continuous I/M costs.  The
cost comparison seems to compare the same fleet of vehicles, i.e., it
assumes that the same number of vehicle will be subject to continuous
I/M that are subject to remote I/M.  However, this logic appears flawed
in that the RIA seems to apply continuous I/M over entire States.  This
application is much wider than current I/M programs.  To have a fair
discussion of costs, the RIA needs to include an analysis of the number
of vehicle that would be subject to the continuous I/M, compared to the
remote I/M.

                    Appendix 5, page 5-6.  As we commented on the PM
NAAQS RIA, this RIA also identifies anti-idling measures as a "no cost"
strategy.  This seems overly simplistic.  Although fuel savings could
offset capital costs, it does not reflect how control measures could be
adopted to actually achieve these reductions.  This may be more true for
MIRTs, but what reasonable control measures could force the installation
of MIRTs?  Capital costs, especially in the case of TSEs, would most
likely be placed upon public entities that would not recoup the fuel
savings.

                    Appendix 5, page 7.  “Reduce Gasoline RVP from
7.8 to 7.0 in Remaining Nonattainment Areas.  Cost-Effectiveness of
Measure:  Cost per ton will be $5,700 to $36,000/ton VOC.”  What is
the basis of this estimate?  What is the source of the data?  This needs
to be discussed and referenced.


[Federal Register: July 21, 2008 (Volume 73, Number 140)]
[Rules and Regulations]
[Page 42259-42262]
[DOCID:fr21jy08-2]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0733; Directorate Identifier 2008-NM-114-AD;
Amendment 39-15617; AD 2008-15-05]
RIN 2120-AA64

Airworthiness Directives; Boeing Model 737-300, -400, and -500
Series Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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SUMMARY: We are adopting a new airworthiness directive (AD) for all
Boeing Model 737-300, -400, and -500 series airplanes. This AD requires
inspecting to determine if certain carriage spindles are installed,
repetitive inspections for corrosion and indications of corrosion on
affected carriage spindles, and if necessary, related investigative
action and corrective action. This AD also provides optional
terminating action. This AD results from a report of corrosion found on
carriage spindles that are located on the outboard trailing edge flaps.
We are issuing this AD to detect and correct corrosion of the carriage
spindle, which could result in fracture. Fracture of both the inboard
and outboard carriage spindles, in the forward ends through

the large diameters, on a flap, could adversely affect the airplane's
continued safe flight and landing.

DATES: This AD is effective August 5, 2008.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of August 5,
2008.
    We must receive comments on this AD by September 19, 2008.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Boeing
Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-2207.

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 AD, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Office (telephone<PHONE_NUMBER>) is in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Nancy Marsh, Aerospace Engineer,
Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
917-6440; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We received a report of corrosion found on carriage spindles that
are located on the outboard trailing edge flaps. The affected carriages
were overhauled after February 2006. The carriage sub-assembly had been
replaced with a new carriage sub-assembly that had a high velocity oxy-
fuel (HVOF) thermal coating applied to the spindle. The HVOF thermal
coating had flaked off, exposing the base metal and allowing corrosion
on the spindle. Boeing is examining parts returned from operators to
find the cause of the coating flaking off. Corrosion of the carriage
spindle, if not detected and corrected, could result in fracture of the
spindle. One fractured carriage spindle on a flap can be compensated
for with pilot inputs to the aileron or rudder, which increases pilot
workload. Fracture of both the inboard and outboard carriage spindles,
in the forward ends through the large diameters, on a single flap,
could adversely affect the airplane's continued safe flight and
landing.

Relevant Service Information

    We reviewed Boeing Alert Service Bulletin 737-57A1304, dated June
2, 2008. The service bulletin describes procedures for:
     An inspection or maintenance records check to determine if
a suspect carriage spindle with HVOF thermal coating is installed;
     Repetitive detailed inspections for corrosion and for
potential indications of corrosion such as flaking metallic particles,
disbonded sealant, or cracked paint or primer of the forward and aft
ends of the affected carriage spindle (with the option to do a
borescope inspection instead on the forward end only);
     Related investigative actions if potential or no
indications of corrosion are found; and
     Corrective action if a corroded, cracked, or severed
spindle is found.
    The related investigative actions involve (1) removing the carriage
to do a detailed inspection of the entire surface of the spindle for
corrosion if potential indications of corrosion were found or (2) for
airplanes on which no corrosion indications were found during the
detailed or optional borescope inspection, doing repetitive gap checks
for differential movement (with an option to do a non-destructive test
(NDT) ultrasonic inspection) for cracking that could indicate a severed
spindle. The corrective action involves replacing a corroded, cracked,
or severed carriage spindle with a new or serviceable carriage spindle.
The service bulletin also provides for an optional terminating action
that involves replacing an HVOF-coated carriage spindle with a non-HVOF
coated carriage spindle.
    The service bulletin specifies a repetitive interval of 90 days for
the detailed inspections (including optional borescope inspection) and
a repetitive interval of 15 days or 150 flight cycles for the gap
checks (including optional NDT ultrasonic inspections).

FAA's Determination and Requirements of This AD

    We are issuing 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(se) same type
design(s). This AD requires accomplishing the actions specified in the
service information described previously, except as discussed under
``Difference Between the AD and the Service Information.''

Interim Action

    This is considered to be interim action. The inspection reports
that are required by this AD will enable the manufacturer to obtain
better insight into the nature, cause, and extent of the discrepant
HVOF coating, and eventually to develop final action to address the
unsafe condition. Once final action has been identified, the FAA might
consider further rulemaking.

FAA's Justification and Determination of the Effective Date

    We received a report of corrosion found on carriage spindles that
are located on the outboard trailing edge flaps. The HVOF coating on
the affected carriage spindle had flaked off, exposing the base metal.
Corrosion occurring on the exposed base metal can quickly lead to
cracking and full fracture of the carriage spindle. Fracture of both
the inboard and outboard carriage spindles, in the forward ends through
the large diameters, on a single flap, could adversely affect the
airplane's continued safe flight and landing. Because of our
requirement to promote safe flight of civil aircraft and thus, the
critical need to assure the structural integrity of the carriage
spindle and the short compliance time involved with this action, this
AD must be issued immediately.
    Because an unsafe condition exists that requires the immediate
adoption of this AD, we find that notice and opportunity for prior
public comment hereon are impracticable and that good cause exists for
making this amendment effective in less than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not provide you with notice and an opportunity to
provide your comments before it becomes effective. However, we invite
you to send any written data, views, or arguments about this AD. Send
your comments to an address listed under the ADDRESSES section. Include
``Docket No. FAA-2008-0733; Directorate Identifier 2008-

NM-114-AD'' at the beginning of your comments. We specifically invite
comments on the overall regulatory, economic, environmental, and energy
aspects of this AD. We will consider all comments received by the
closing date and may amend this AD because of those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Authority for This Rulemaking

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

Regulatory Findings

    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 DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979), and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    You can find our regulatory evaluation and the estimated costs of
compliance in the AD Docket.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2008-15-05 Boeing: Amendment 39-15617. Docket No. FAA-2008-0733;
Directorate Identifier 2008-NM-114-AD.

Effective Date

    (a) This airworthiness directive (AD) is effective August 5,
2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to all Boeing Model 737-300, -400, and -500
series airplanes, certificated in any category.

Unsafe Condition

    (d) This AD results from a report of corrosion found on carriage
spindles that are located on the outboard trailing edge flaps. We
are issuing this AD to detect and correct corrosion of the carriage
spindle, which could result in fracture. Fracture of both the
inboard and outboard carriage spindles, in the forward ends through
the large diameters, on a single flap, could adversely affect the
airplane's continued safe flight and landing.

Compliance

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

Inspection To Determine Affected Carriage Spindle

    (f) Within 30 days after the effective date of this AD, inspect
the carriage sub-assembly to determine whether an affected carriage
spindle with a high velocity oxy-fuel (HVOF) thermal coating is
installed, in accordance with the Accomplishment Instructions of
Boeing Alert Service Bulletin 737-57A1304, dated June 2, 2008. A
review of airplane maintenance records is acceptable in lieu of this
inspection if the part number and/or serial number of the carriage
can be conclusively determined from that review. If no affected
carriage spindle is installed, no further action is required by this
paragraph.

Repetitive Inspections, Related Investigative Actions, and Corrective
Action

    (g) For airplanes on which any affected carriage spindle is
installed: At the later of the times specified in paragraphs (g)(1)
and (g)(2) of this AD, do a detailed inspection (or, as an option
for the forward end of the spindle only, a borescope inspection
technique may be used) of the spindle for corrosion and potential
indications of corrosion of the carriage spindle, and do all
applicable related investigative and corrective actions, in
accordance with the Accomplishment Instructions of Boeing Alert
Service Bulletin 737-57A1304, dated June 2, 2008. Do all applicable
related investigative actions and corrective actions before further
flight. Repeat the detailed inspection (or, as an option for the
forward end of the spindle only, the borescope inspection) and
certain related investigative actions (i.e., the gap-check or
optional non-destructive test (NDT) ultrasonic inspection) at the
applicable compliance times specified in the service bulletin.
    (1) Within 30 days after the effective date of this AD.
    (2) Within 90 days after the installation of a new HVOF-coated
spindle.

    Note 1: Boeing Alert Service Bulletin 737-57A1304, dated June 2,
2008, references Boeing Alert Service Bulletin 737-57A1277, Revision
1, dated November 25, 2003, for further information on accomplishing
the related investigative actions.

Inspection Report

    (h) If any corrosion, cracking, or severed spindle is found
during any inspection required by paragraph (g) of this AD: Within
10 days after the inspection, or within 10 days after the effective
date of this AD, whichever occurs later, submit a report of the
inspection results to the Manager, Airline Support, Boeing
Commercial Airlines Group, as specified in Note 2 of paragraph 1.D.,
``Description,'' of Boeing Alert Service Bulletin 737-57A1304, dated
June 2, 2008. Information collection requirements contained in this
AD have been approved by the Office of Management and Budget (OMB)
under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
et seq.) and have been assigned OMB Control Number 2120-0056.

Optional Terminating Action

    (i) Replacement of an HVOF-coated carriage spindle with a non-
HVOF coated carriage spindle in accordance with Boeing Alert Service
Bulletin 737-57A1304, dated June 2, 2008, terminates the
requirements of this AD for that carriage spindle only.

Parts Installation

    (j) As of the effective date of this AD, an HVOF-coated spindle
may be installed on an airplane provided the actions required by
paragraph (g) of this AD are done on that spindle.

Alternative Methods of Compliance (AMOCs)

    (k)(1) The Manager, Seattle ACO, FAA, ATTN: Nancy Marsh,
Aerospace Engineer, Airframe Branch, ANM-120S, 1601 Lind Avenue,
SW., Renton, Washington 98057-3356; telephone<PHONE_NUMBER>; fax
(425) 917-6590; has the authority to approve AMOCs for this AD, if
requested, using the procedures found in 14 CFR 39.19.

    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD, if it is approved by an
Authorized Representative for the Boeing Commercial Airplanes
Delegation Option Authorization Organization who has been authorized
by the Manager, Seattle ACO, to make those findings. For a repair
method to be approved, the repair must meet the certification basis
of the airplane, and the approval must specifically refer to this
AD.

Material Incorporated by Reference

    (l) You must use Boeing Alert Service Bulletin 737-57A1304,
dated June 2, 2008, to do the actions required by this AD, unless
the AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington
98124-2207.
    (3) You may review copies of the service information
incorporated by reference at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington; or at the
National Archives and Records Administration (NARA). For information
on the availability of this material at NARA, call<PHONE_NUMBER>, or
go to: http://www.archives.gov/federal_register/code_of_federal_
regulations/ibr_locations.html.

    Issued in Renton, Washington, on July 10, 2008.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E8-16483 Filed 7-18-08; 8:45 am]

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