[Federal Register Volume 79, Number 174 (Tuesday, September 9, 2014)]
[Notices]
[Pages 53500-53503]
[FR Doc No: 2014-21356]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72961; File No. SR-NASDAQ-2014-081]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing of Proposed Rule Change Relating to Proposed Changes
to NASDAQ Rule 4120(c) To Modify the Parameters for Releasing
Securities for Trading Upon the Termination of a Trading Halt in a
Security That is the Subject of an Initial Public Offering

September 3, 2014.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on August 20, 2014, The NASDAQ Stock Market LLC (``NASDAQ'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in in Items I,
II, and III below, which Items have been prepared by NASDAQ. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    NASDAQ proposes to amend NASDAQ Rule 4120(c) to modify the
parameters for releasing securities for trading upon the termination of
a trading halt in a security that is the subject of an initial public
offering.
    The text of the proposed rule change is available at http://nasdaq.cchwallstreet.com/, at NASDAQ's principal office, and at the
Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, NASDAQ included statements
concerning the purpose of, and basis for, the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. NASDAQ has prepared summaries, set forth in Sections A,
B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend Rule 4120(c) to strengthen
safeguards against unexpected volatility with respect to the price
established by the NASDAQ Halt Cross for a security that is the subject
of an IPO (the ``IPO Halt Cross'' or the ``Cross''). In 2013, NASDAQ
adopted a new process for releasing IPO securities.\3\ The changes were
adopted to improve the IPO release process by increasing NASDAQ's
flexibility to commence trading when appropriate. To this end, NASDAQ
eliminated the former rule requirement that limited the number of
extensions of the period prior to launch--the Display Only Period--to
six five-minute periods. NASDAQ instead adopted a two-phase process
under which the initial 15-minute Display Only Period is followed by a
``Pre-Launch Period'' that is not of a fixed duration. Under the
current rule, the Pre-Launch Period will continue until (1) NASDAQ
receives notice from the underwriter of the IPO that the security is
ready to trade and there is no ``order imbalance'' in the security, in
which case the security is released for trading; or (2) the
underwriter, with concurrence of NASDAQ, determines to postpone and
reschedule the IPO. Every five seconds during the Display Only Period
and the Pre-Launch Period, NASDAQ disseminates the Current Reference
Price, an indication of the price at which the IPO Halt Cross would
execute if it occurred at that time.
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    \3\ Securities Exchange Act Release No. 69897 (July 1, 2013), 78
FR 40782 (July 8, 2013) (SR-NASDAQ-2013-092). See also Securities
Exchange Act Release No. 70911 (November 21, 2013), 78 FR 71011
(November 27, 2013) (SR-NASDAQ-2013-143) (adopting additional
refinements to process for IPO securities).
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    The requirement regarding the absence of an order imbalance was
designed to ensure that the expected price of the security is
reasonably stable and that trading interest is balanced at the time
trading commences. There are currently several conditions under which
an order imbalance in an IPO security will be considered to exist:
     The Current Reference Price disseminated immediately prior
to commencing the release of the IPO for trading during the Pre-Launch
Period and any of the three preceding Current Reference Prices differ
by more than the greater of 5 percent or 50 cents;
     upon completion of the Cross calculation, the calculated
price at which the security would be released for trading and any of
the three preceding Current Reference Prices disseminated immediately
prior to the initiation of the Cross calculation differ by more than
the greater of 5 percent or 50 cents; or
     all market orders will not be executed in the Cross.
    These restrictions are designed to prevent circumstances where a
misunderstanding by the underwriter as to the state of the order book
risks launching trading at a time of material volatility in the book
for the security. Order imbalances are calculated by the IPO Halt Cross
system, which automatically prevents launch of a halted security when
an order imbalance exists.
    NASDAQ is proposing to enable the underwriter to provide even
greater protection against volatility in an IPO security by replacing
the current system for comparing against prior Current Reference Prices
with a system under which the expected price of the IPO Halt Cross will
be displayed to the underwriter, who will then select price bands to
ensure that the actual calculated price at which the IPO Halt Cross
would occur does not deviate from the expected price by more than the
selected amounts. Such price deviations are possible because market
participants may continue to enter and cancel orders during the period
between the display of the expected price to the underwriter and the
commencement of the Cross calculation, a period of up to five seconds
in duration.\4\ Although the current system has generally done a good
job of protecting against unexpected changes in the pricing of an IPO
Halt Cross by ensuring that the Current Reference Price has been stable
and the final calculated price is not significantly different from
preceding Current Reference Prices, the proposed change would introduce
the opportunity for underwriters to set tighter limits at their
discretion based on the characteristics of and expectations for each
IPO.
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    \4\ Cancellations received following the commencement of the
Cross calculation are blocked, and orders received thereafter are
not Cross-eligible. See In the Matter of The NASDAQ Stock Market LLC
and NASDAQ Execution Services, LLC, Securities Exchange Act Release
No. 69655 (May 29, 2013), at ]65.
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    Under the proposed modified system, the Pre-Launch Period will end
and the security will be released for trading when the following
conditions are all met:
     NASDAQ receives notice from the underwriter of the IPO
that the security is ready to trade. The NASDAQ system will calculate
the Current Reference Price at that time (the ``Expected Price'') and
display it to the underwriter. If the underwriter then approves
proceeding, the NASDAQ system will conduct the following validation
checks:
     The NASDAQ system must determine that all market orders
will be executed in the cross; \5\
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    \5\ This requirement is not being modified from the requirement
of the current rule with respect to market orders, but the wording
is being modified to make it clearer. The intent of the restriction
is to ensure that if a market participant enters an order offering
to buy or sell in the IPO Halt Cross at any price, the Cross should
not occur unless all such orders can be executed.
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     the security passes a new price validation test, which
will replace the current system for comparison against recent Current
Reference Prices.
    For purposes of applying the price validation test, the underwriter
must select price bands prior to the conclusion of the Pre-Launch
Period.\6\ The System will then compare the Expected Price with the
actual price calculated by the Cross. If the actual price calculated by
the Cross differs from the Expected Price by an amount in excess of the
price band selected by the underwriter, the security will not be
released for trading and the Pre-Launch Period will continue. The
underwriter must select an upper price band (i.e., an amount by which
the actual price may not exceed the Expected Price) and a lower price
band (i.e., an amount by which the actual price may not be lower than
the Expected Price). If a security does not pass the price validation
test, the underwriter may, but is not required to, select different
price bands before recommencing the process to release the security for
trading.
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    \6\ The underwriter can select the price bands at any time
during the Display Only Period or Pre-Launch Period, and can modify
them at any time prior to the conclusion of the Pre-Launch Period.
---------------------------------------------------------------------------

    For example, assume that the Expected Price for the IPO Halt Cross
shown to the underwriter was $32 per share, and the underwriter
selected an upper price band of $0.10 and a lower price band of $0.05.
In that case, the actual price calculated by the system for the Cross
could not be higher than $32.10 nor lower than $31.95.
    As is currently the case, the failure to satisfy any of the
conditions for completion of the IPO Cross results in a delay of the
release for trading of the IPO, and a continuation of the Pre-Launch
Period, until all conditions have been satisfied. Thus, if the price
validation is not satisfied, the Pre-Launch Period would continue
seamlessly, with members able to continue to enter or cancel orders.
The security would then repeat the process for release until such time
as the

conditions required for launch were satisfied. Thus, the underwriter
would again have to determine that it believes the security is ready to
trade, the underwriter would be shown the applicable Expected Price,
and the security would launch if all market orders would be executed
and the price validation was satisfied. As noted above, the underwriter
would be able to select different price bands for each attempt to
launch the security. Thus, an underwriter might select an upper and a
lower band of $0 initially, such that the security would not launch
unless the calculated price equaled the Expected Price. If the security
did not pass the validation check, however, the underwriter could
subsequently choose to widen the price bands to allow the IPO to
proceed at a price that might vary from the Expected Price. As is also
currently the case, the underwriter, with concurrence of NASDAQ, may
determine at any point during the IPO Halt Cross process up through the
conclusion of the Pre-Launch Period to postpone and reschedule the
IPO.\7\
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    \7\ NASDAQ is modifying the applicable language slightly to make
it clear that the authority to cancel and reschedule extends to the
conclusion of the Pre-Launch Period.
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    The price bands available for selection shall be in such
increments, and at such price points, as may be established from time
to time by NASDAQ. The initial available price bands will range from $0
to $0.50, with increments of $0.01. Thus, the underwriter may select a
price band of $0 (i.e., no change from the Expected Price is
permitted), $0.01, $0.02, or any other $0.01 increment up to $0.50. The
underwriter may select different price bands above and below the
Expected Price. NASDAQ reserves the right to stipulate wider increments
(such as $0.05) or price bands that include certain price points but
exclude others (for example, increments of $0.01 up to $0.10, and
increments of $0.05 thereafter). In selecting available price bands and
increments, NASDAQ will consider input from underwriters and other
market participants and the results of past usage of price bands to
adopt price bands and increments that promote efficiency in the
initiation of trading and protect investors and the public interest.
NASDAQ will notify member organizations and the public of changes in
available price band or increments through a notice that is widely
disseminated at least one week in advance of the change. However,
NASDAQ will not (in the absence of the submission of a proposed rule
change) allow bands wider than $0.50. Thus, bands will not be wider
than the bands that currently govern the comparison between the Cross
price and previous Current Reference Prices.
    In addition to the foregoing changes, NASDAQ is also proposing to
reorganize provisions of Rule 4120 relating to the process for ending a
trading halt of securities other than IPO securities. NASDAQ is not
making substantive modifications to these rules, however.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Act,\8\ in general, and with
Section 6(b)(5) of the Act,\9\ in particular, in that it is designed to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitating
transaction in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system and,
in general, to protect investors and the public interest. The proposed
rule change promotes these goals by strengthening protection against
unexpected volatility in the pricing of an IPO security. While the
current rule provides protection against volatility by providing that
the final price of an IPO security calculated by the IPO Halt Cross may
not deviate from the most recent three indicative prices by more than
five percent or $0.50, there nevertheless exists the possibility that
deviations within these bands will occur. The proposed change is
designed to protect the underwriter and other market participants from
the IPO Halt Cross occurring at a price that deviates unexpectedly from
the prices previously disclosed through the Current Reference Price by
providing the underwriter the authority to set tighter limits based on
the characteristics of and expectations for each IPO. NASDAQ believes
that enhancing and strengthening the process in this manner will
protect investors as it will serve to minimize unexpected price
deviations and avoid confusion among market participants.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f.
    \9\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act, as amended.
Specifically, the change will not affect the ability of market
participants to participate fully in the IPO Halt Crosses. Rather, the
change is designed to promote stability and reduce volatility in the
pricing of the IPO Halt Cross, and therefore does not impose any
restriction on competition.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission shall: (a) by order approve
or disapprove such proposed rule change, or (b) institute proceedings
to determine whether the proposed rule change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2014-081 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-NASDAQ-2014-081. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written

communications relating to the proposed rule change between the
Commission and any person, other than those that may be withheld from
the public in accordance with the provisions of 5 U.S.C. 552, will be
available for Web site viewing and printing in the Commission's Public
Reference Room, 100 F Street NE., Washington, DC 20549, on official
business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of
such filing also will be available for inspection and copying at the
principal offices of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NASDAQ-2014-081, and should be submitted on or before
September 30, 2014.
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    \10\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-21356 Filed 9-8-14; 8:45 am]
BILLING CODE 8011-01-P


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[Federal Register Volume 80, Number 115 (Tuesday, June 16, 2015)]
[Rules and Regulations]
[Pages 34276-34279]
[FR Doc No: 2015-14734]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 526, and 528

[Docket No. FDA-2015-N-0002]

New Animal Drugs; Approval of New Animal Drug Applications;
Change of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect application-related actions for new animal
drug applications (NADAs) and

abbreviated new animal drug applications (ANADAs) during March and
April 2015. 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 several nonsubstantive changes. These technical
amendments are being made to improve the accuracy of the regulations.

DATES: This rule is effective June 16, 2015.

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 March and April
2015, 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.

                                Table 1--Original and Supplemental NADAs and ANADAs Approved During March and April 2015
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                New animal drug product                               21 CFR
    NADA/ANADA               Sponsor                     name                     Action             sections       FOIA summary         NEPA review
--------------------------------------------------------------------------------------------------------------------------------------------------------
200-557...........  Putney, Inc., One          Tiletamine-Zolazepam      Original approval as a       522.2470  yes................  CE \1\ \2\.
                     Monument Sq., suite 400,   Injectable Solution       generic copy of NADA
                     Portland, ME 04101.        (tiletamine HCl and       106-111.
                                                zolazepam HCl).
200-578...........  Belcher Pharmaceuticals,   Carprofen Flavored        Original approval as a        520.304  yes................  CE \1\ \2\.
                     LLC, 6911 Bryan Dairy      Tablets (carprofen).      generic copy of NADA
                     Rd., Largo, FL 33777.                                141-053.
200-579...........  Ceva Sant[eacute]          Altrenogest Solution      Original approval as a         520.48  yes................  CE \1\ \2\.
                     Animale, 10 Avenue de la   (altrenogest).            generic copy of NADA
                     Ballasti[egrave]re,                                  141-222.
                     33500 Libourne, France.
141-238...........  Zoetis Inc., 333 Portage   SPECTRAMAST LC            Supplemental approval         526.313  yes................  CE \1\ \3\.
                     St., Kalamazoo, MI 49007.  (ceftiofur intramammary   for treatment of
                                                suspension) Sterile       diagnosed subclinical
                                                Suspension.               mastitis associated
                                                                          with coagulase-negative
                                                                          staphylococci and
                                                                          Streptococcus
                                                                          dysgalactiae in
                                                                          lactating dairy cattle.
200-134...........  Intervet, Inc., 2 Giralda  FERTAGYL (gonadorelin)    Supplemental approval        522.1077  yes................  EA/FONSI \4\.
                     Farms, Madison, NJ 07940.  Sterile Solution.         under section 512(b)(1)
                                                                          of the FD&C Act for use
                                                                          with cloprostenol
                                                                          injection to
                                                                          synchronize estrous
                                                                          cycles to allow for
                                                                          fixed time artificial
                                                                          insemination (FTAI) in
                                                                          lactating dairy cows.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The Agency has determined 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 have a significant effect on the human environment.
\2\ CE granted under 21 CFR 25.33(a)(1).
\3\ CE granted under 21 CFR 25.33(d)(5).
\4\ 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).

    In addition during March and April 2015, ownership of, and all
rights and interest in, the following approved applications have been
transferred as follows:

----------------------------------------------------------------------------------------------------------------
                                                New animal drug product                                 21 CFR
    NADA/ANADA           Previous sponsor                 name                   New sponsor           section
----------------------------------------------------------------------------------------------------------------
140-883...........  Bayer HealthCare LLC,      LEGEND (hyaluronate        Merial, Inc., 3239            522.1145
                     Animal Health Division,    sodium) Injectable         Satellite Blvd., Bldg.
                     P.O. Box 390, Shawnee,     Solution.                  500, Duluth, GA 30096.
                     Mission, KS 66201.
141-188...........  Bayer HealthCare LLC,      MARQUIS (ponazuril)        Merial, Inc., 3239            520.1855
                     Animal Health Division,    Antiprotozoal Oral Paste.  Satellite Blvd., Bldg.
                     P.O. Box 390, Shawnee,                                500, Duluth, GA 30096.
                     Mission, KS 66201.
141-294...........  rEVO Biologics, 175        Bc6 rDNA construct in GTC  LFB USA, Inc.,<PHONE_NUMBER>
                     Crossing Blvd.,            155-92 goats.              Crossing Blvd.,
                     Framingham, MA 01702.                                 Framingham, MA 01702.
----------------------------------------------------------------------------------------------------------------

At this time, the regulations are being amended to reflect these
changes of sponsorship.
    Following these changes of sponsorship, LFB USA, Inc., is now the
sponsor of an approved application. Accordingly, Sec.  510.600 (21 CFR
510.600) is being amended to add this

firm to the list of sponsors of approved applications.
    The animal drug regulations are also being amended to reflect
several non-substantive changes. These technical amendments are 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.

List of Subjects

21 CFR Part 510

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

21 CFR Parts 520, 522, 526, and 528

    Animal drugs.

    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, 526, and 528 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 entry
for ``Abbott Laboratories'' and add in alphabetical order an entry for
``LFB USA, Inc.''; and in the table in paragraph (c)(2), remove the
entry for 000044 and add in numerical order an entry for ``086047'' 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
------------------------------------------------------------------------

                                * * * * *
LFB USA, Inc., 175 Crossing Blvd., Framingham, MA 01702.          086047

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

    (2) * * *

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

                                * * * * *
086047.................................  LFB USA, Inc., 175 Crossing
                                          Blvd., Framingham, MA 01702

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

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.

0
4. In Sec.  520.48, revise paragraph (b) to read as follows:

Sec.  520.48  Altrenogest.

* * * * *
    (b) Sponsors. See Nos. 000061 and 013744 in Sec.  510.600(c) of
this chapter.
* * * * *

Sec.  520.88g  [Amended]

0
5. In Sec.  520.88g, in paragraph (c)(2)(i), remove ``(1 milliliter)''.
0
6. In Sec.  520.154a:
0
a. Revise the section heading;
0
b. In paragraphs (d)(1)(ii), (d)(2)(i)(A), (d)(2)(ii)(A), and
(d)(4)(ii), remove ``bacitracin methylene disalicylate'' and in its
place add ``bacitracin methylenedisalicylate''; and
0
c. In paragraph (d)(3)(ii), remove ``Treponema hyodysenteriae'' and in
its place add ``Brachyspira hyodysenteriae''.
    The revision reads as follows:

Sec.  520.154a  Bacitracin methylenedisalicylate.

* * * * *

Sec.  520.304  [Amended]

0
7. In Sec.  520.304, in paragraph (b)(3), remove ``No. 026637'' and in
its place add ``Nos. 026637 and 062250''.

Sec.  520.804  [Amended]

0
8. In Sec.  520.804, redesignate paragraphs (c)(i), (c)(ii), and
(c)(iii), as paragraphs (c)(1), (c)(2), and (c)(3).

0
9. In Sec.  520.1660d, revise paragraph (a)(4) to read as follows:

Sec.  520.1660d  Oxytetracycline powder.

    (a) * * *
    (4) Each 2.73 grams of powder contains 1 gram of OTC HCl (packets:
2.46 and 9.87 oz, 3.09 and 3.91 lb; pail: 3.09 lb).
* * * * *

Sec.  520.1855  [Amended]

0
10. In Sec.  520.1855, in paragraph (b), remove ``000859'' and in its
place add ``050604''.

0
11. In Sec.  520.2218, revise paragraphs (d)(1)(i)(A) and (B), and
paragraphs (d)(2)(i)(A) and (B) to read as follows:

Sec.  520.2218  Sulfamerazine, sulfamethazine, and sulfaquinoxaline
powder.

* * * * *
    (d) * * *
    (1) * * *
    (i) * * *
    (A) As an aid in the control of coccidiosis caused by Eimeria
tenella and E. necatrix susceptible to sulfamerazine, sulfamethazine,
and sulfaquinoxaline: Provide medicated water (0.04 percent solution)
for 2 to 3 days, then plain water for 3 days, then medicated water
(0.025 percent solution) for 2 days. If bloody droppings appear, repeat
at 0.025 percent level for 2 more days. Do not change litter.
    (B) As an aid in the control of acute fowl cholera caused by
Pasteurella multocida susceptible to sulfamerazine, sulfamethazine, and
sulfaquinoxaline: Provide medicated water (0.04 percent solution) for 2
to 3 days. If disease recurs, repeat treatment.
* * * * *
    (2) * * *
    (i) * * *
    (A) As an aid in the control of coccidiosis caused by Eimeria
meleagrimitis and E. adenoeides susceptible to sulfamerazine,
sulfamethazine, and sulfaquinoxaline: Provide medicated water (0.025
percent solution) for 2 days, then plain water for 3 days, then
medicated water (0.025 percent solution) for 2 days, then plain water
for 3 days, then medicated water (0.025 percent solution) for 2 days.
Repeat if necessary. Do not change litter.
    (B) As an aid in the control of acute fowl cholera caused by
Pasteurella multocida susceptible to sulfamerazine, sulfamethazine, and
sulfaquinoxaline: Provide medicated water (0.04 percent solution) for 2
to 3 days. If disease recurs, repeat treatment.
* * * * *

Sec.  520.2640  [Amended]

0
12. In Sec.  520.2640, in paragraphs (e)(2)(iii) and (e)(3)(iii),
remove the first sentence.

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

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

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

Sec. Sec.  522.1073 and 522.1075  [Removed]

0
14. Remove Sec. Sec.  522.1073 and 522.1075.

0
15. Revise Sec.  522.1077 to read as follows:

Sec.  522.1077  Gonadorelin.

    (a) Specifications. Each milliliter (mL) of solution contains:
    (1) 43 micrograms ([micro]g) of gonadorelin as gonadorelin acetate;
    (2) 100 [micro]g of gonadorelin as gonadorelin acetate;
    (3) 50 [micro]g of gonadorelin as gonadorelin diacetate
tetrahydrate; or
    (4) 50 [micro]g of gonadorelin as gonadorelin hydrochloride.
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this
chapter.
    (1) No. 000061 for use of the 43-[micro]g/mL product described in
paragraph (a)(1) as in paragraphs (d)(1)(i), (d)(1)(iv), and (d)(2) of
this section.
    (2) No. 068504 for use of the 100-[micro]g/mL product described in
paragraph (a)(2) as in paragraphs (d)(1)(ii), (d)(1)(v), and (d)(2) of
this section.
    (3) Nos. 000859 and 050604 for use of the 50-[micro]g/mL product
described in paragraph (a)(3) as in paragraphs (d)(1)(ii) and (d)(2) of
this section.
    (4) No. 054771 for use of the 50-[micro]g/mL product described in
paragraph (a)(4) as in paragraphs (d)(1)(iii), (d)(1)(vi), and (d)(2)
of this section.
    (c) Special considerations. Concurrent luteolytic drug use is
approved as follows:
    (1) Cloprostenol injection for use as in paragraph (d)(1)(iv) of
this section as provided by No. 000061 in Sec.  510.600(c) of this
chapter.
    (2) Cloprostenol injection for use as in paragraph (d)(1)(v) of
this section as provided by No. 000061 or No. 068504 in Sec.
510.600(c) of this chapter.
    (3) Dinoprost injection for use as in paragraph (d)(1)(vi) of this
section as provided by No. 054771 in Sec.  510.600(c) of this chapter.
    (d) Conditions of use in cattle--(1) Indications for use and
amounts--(i) For the treatment of ovarian follicular cysts in dairy
cattle: Administer 86 [mu]g gonadorelin by intramuscular or intravenous
injection.
    (ii) For the treatment of ovarian follicular cysts in dairy cattle:
Administer 100 [mu]g gonadorelin by intramuscular or intravenous
injection.
    (iii) For the treatment of ovarian follicular cysts in cattle:
Administer 100 [mu]g gonadorelin by intramuscular injection.
    (iv) For use with cloprostenol injection to synchronize estrous
cycles to allow for fixed-time artificial insemination (FTAI) in
lactating dairy cows: Administer to each cow 86 [mu]g gonadorelin by
intramuscular injection, followed 6 to 8 days later by 500 [mu]g
cloprostenol by intramuscular injection, followed 30 to 72 hours later
by 86 [mu]g gonadorelin by intramuscular injection.
    (v) For use with cloprostenol injection to synchronize estrous
cycles to allow for fixed-time artificial insemination (FTAI) in
lactating dairy cows and beef cows: Administer to each cow 100 [mu]g
gonadorelin by intramuscular injection, followed 6 to 8 days later by
500 [mu]g cloprostenol by intramuscular injection, followed 30 to 72
hours later by 100 [mu]g gonadorelin by intramuscular injection.
    (vi) For use with dinoprost injection to synchronize estrous cycles
to allow fixed-time artificial insemination (FTAI) in lactating dairy
cows: Administer to each cow 100 to 200 [mu]g gonadorelin by
intramuscular injection, followed 6 to 8 days later by 25 mg dinoprost
by intramuscular injection, followed 30 to 72 hours later by 100 to 200
[mu]g gonadorelin by intramuscular injection.
    (2) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.

Sec.  522.1145  [Amended]

0
16. In Sec.  520.1145, in paragraph (e)(2)(i), remove ``000859'' and in
its place add ``050604''.

0
17. In Sec.  522.2470, revise paragraph (b) to read as follows:

Sec.  522.2470  Tiletamine and zolazepam for injection.

* * * * *
    (b) Sponsors. See Nos. 026637 and 054771 in Sec.  510.600(c) of
this chapter.
* * * * *

0
18. In Sec.  522.2483, revise paragraph (b) to read as follows:

Sec.  522.2483  Triamcinolone.

* * * * *
    (b) Sponsors. See Nos. 000010 and 054628 in Sec.  510.600(c) of
this chapter.
* * * * *

PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

0
19. The authority citation for 21 CFR part 526 continues to read as
follows:

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

0
20. In Sec.  526.313, revise paragraph (d)(1)(ii) to read as follows:

Sec.  526.313  Ceftiofur.

* * * * *
    (d) * * *
    (1) * * *
    (ii) Indications for use. For use in lactating dairy cattle:
    (A) For the treatment of clinical mastitis associated with
coagulase-negative staphylococci, Streptococcus dysgalactiae, and
Escherichia coli; and
    (B) For the treatment of diagnosed subclinical mastitis associated
with coagulase-negative staphylococci and S. dysgalactiae.
* * * * *

PART 528--NEW ANIMAL DRUGS IN GENETICALLY ENGINEERED ANIMALS

0
21. The authority citation for 21 CFR part 528 continues to read as
follows:

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

Sec.  528.1070  [Amended]

0
22. In Sec.  528.1070, in paragraph (b), remove ``042976'' and in its
place add ``086047''.

    Dated: June 11, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015-14734 Filed 6-15-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 107 (Friday, June 3, 2022)]
[Proposed Rules]
[Pages 33697-33699]
[FR Doc No: 2022-11971]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2022-0439; FRL-9870-01-R9]

Air Plan Approval; California; San Diego County Air Pollution
Control District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a revision to the San Diego County Air Pollution Control
District's (SDCAPCD or District) portion of the California State
Implementation Plan (SIP). This revision concerns a volatile organic
compound (VOC) rule covering transfer of organic compounds into mobile
transport trucks and a negative declaration for non-Control Techniques
Guidelines (CTG) major VOC sources. We are proposing to approve the
local rule to regulate these emission sources under the Clean Air Act
(CAA or the Act) and the negative declaration. We are taking comments
on this proposal and plan to follow with a final action. Elsewhere in
this Federal Register, we are making an interim final determination to
defer CAA sanctions associated with our previous disapproval action
concerning the CTG categories addressed by the rule and negative
declaration.

DATES: Comments must be received on or before July 5, 2022.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2022-0439 at https://www.regulations.gov. For comments submitted at
Regulations.gov, follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or removed from
Regulations.gov. The EPA may publish any comment received to its public
docket. Do not submit electronically any information you consider to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Multimedia submissions (audio,
video, etc.) must be accompanied by a written comment. The written
comment is considered the official comment and should include
discussion of all points you wish to make. The EPA will generally not
consider comments or comment contents located outside of the primary
submission (i.e., on the web, cloud, or other file sharing system). For
additional submission methods, please contact the person identified in
the FOR FURTHER INFORMATION CONTACT section. For the full EPA public
comment policy, information about CBI or multimedia submissions, and
general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets. If you need assistance in a
language other than English or if you are a person with disabilities
who needs a reasonable accommodation at no cost to you, please contact
the person identified in the FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Donnique Sherman, EPA Region IX, 75
Hawthorne St., San Francisco, CA 94105. By phone:<PHONE_NUMBER> or by
email at [email protected].

SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA.

Table of Contents

I. The State's Submittal
    A. What documents did the State submit?
    B. Are there other versions of these documents?
    C. What is the purpose of the submitted documents?
II. The EPA's Evaluation and Action
    A. How is the EPA evaluating the submitted documents?
    B. Do the documents meet the evaluation criteria?
    C. The EPA's Recommendations To Further Improve the Submitted
Rules
    D. Public Comment and Proposed Action
III. Incorporation by Reference
IV. Statutory and Executive Order Reviews

I. The State's Submittal

A. What documents did the State submit?

    Table 1 lists the submissions addressed by this proposal with the
dates they were adopted or amended by the local air agency and
submitted by the California Air Resources Board (CARB) to the EPA.

                                               Table 1--Submittals
----------------------------------------------------------------------------------------------------------------
                                                                                Adopted/
                Local agency                            Document title                amended        Submitted
----------------------------------------------------------------------------------------------------------------
SDCAPCD....................................  Rule 61.2 Transfer of Organic            02/10/2021      04/20/2021
                                              Compounds into Mobile Transport
                                              Tanks.
SDCAPCD....................................  2020 Reasonably Available Control        10/14/2020      12/29/2020
                                              Technology (RACT) Demonstration
                                              for the National Ambient Air
                                              Quality Standards for Ozone in San
                                              Diego County, October 2020--
                                              Negative Declaration for Non-CTG
                                              Major VOC Sources.
----------------------------------------------------------------------------------------------------------------

    Under CAA section 110(k)(1), the EPA must determine whether a SIP
submittal meets the minimum completeness criteria established in 40 CFR
part 51, appendix V for an official SIP submittal on which the EPA is
obligated to take action. If the EPA does not make an affirmative
determination of completeness or incompleteness within six months of
receipt of a SIP submittal, the submittal is deemed to be complete by
operation of law. The submittals listed in Table 1 were deemed complete
by operation of law on October 20, 2021 (Rule 61.2) and June 29, 2021
(SDCAPCD's negative declaration).

B. Are there other versions of these documents?

    We approved a previous version of Rule 61.2 (locally amended on
July 26, 2000) into the California SIP on August 26, 2003 (68 FR
51186). The SDCAPCD adopted revisions to the SIP-approved version on
February 10, 2021, and CARB submitted them to us on April 20, 2021. If
we take final action to approve the February 10, 2021 version of Rule
61.2, this version will replace the previously approved version of this
rule in the SIP.
    We approved portions of the RACT SIP and negative declarations on
December 3, 2020 (85 FR 77996), not including the negative declaration
for non-CTG major VOC sources because the SDCAPCD had not formally
adopted it. The SDCAPCD formally adopted the negative declaration for
non-CTG major VOC sources on October 14, 2020, and CARB submitted it to
us on December 29, 2020.

C. What is the purpose of the submitted documents?

    Emissions of VOCs contribute to the production of ground-level
ozone, smog and particulate matter, which harm human health and the
environment. Section 110(a) of the CAA requires states to submit
regulations that control VOC emissions. Sections 182(b)(2) and (f)
require that SIPs for ozone nonattainment areas classified as Moderate
or above implement RACT for any source covered by Control Techniques
Guidelines (CTG). The SDCAPCD is subject to this requirement as it
regulates an ozone nonattainment area that, at the time it prepared the
original submittal for the negative declaration and Rule 61.2, was
designated and classified as a Moderate nonattainment area for the 2008
8-hour ozone NAAQS. Therefore, the SDCAPCD must, at a minimum, adopt
RACT-level controls for all sources covered by a CTG document and for
all major non-CTG sources of VOCs within the ozone nonattainment area
that it regulates. Any stationary source that emits or has the
potential to emit at least 100 tons per year (tpy) of VOCs or
NOX is a major stationary source in a Moderate ozone
nonattainment area (CAA section 182(b)(2), (f) and 302(j)).
    On December 3, 2020 (85 FR 77996), the EPA partially disapproved
the SDCAPCD's 2008 RACT SIP demonstration for the source category
covering the CTG for ``Control of Hydrocarbon from Tank Truck Gasoline
Loading Terminals'' (EPA 450/2-77-026) (Tank Truck Gasoline Loading
CTG). The EPA's technical support document (TSD) for the proposal
(August 10, 2020, 85 FR 48127) states that, ``. . . Rule 61.2 sets a
limit of 0.29 lb/1,000 gallons for transfers at bulk terminals. We
determined that Rule 61.2 did not meet current RACT for tank truck
loading at bulk terminals. This limit is higher than the emissions
limit in nearly every nonattainment area in California, and in a number
of nonattainment areas outside California.'' In addition, our partial
disapproval of SDCAPCD's 2008 RACT SIP also included a disapproval of
the District's RACT demonstration for non-CTG major sources of VOCs.
The District had not formally adopted a negative declaration for non-
CTG major VOC sources.
    On December 29, 2020, CARB submitted to the EPA the SDCAPCD's 2015
RACT SIP, which includes a negative declaration adopted for non-CTG
major VOC sources for the 2008 RACT SIP which corrects the deficiency
in EPA's 2020 disapproval action for the non-CTG major VOC source
category. On April 20, 2021, CARB submitted to the EPA amended Rule
61.2 that included a decrease in emission limit for bulk terminals to
0.08 pound per 1,000 gallons, which corrects the deficiency in EPA's
2020 disapproval action for the Tank Truck Gasoline Loading CTG
category. The EPA's TSD has more information.

II. The EPA's Evaluation and Action

A. How is the EPA evaluating the submitted documents?

    Rules in the SIP must be enforceable (see CAA section 110(a)(2)),
must not interfere with applicable requirements concerning attainment
and reasonable further progress or other CAA requirements (see CAA
section 110(l)), and must not modify certain SIP control requirements
in nonattainment areas without ensuring equivalent or greater emissions
reductions (see CAA section 193).
    Generally, SIP rules must require reasonably available control
technology (RACT) for each category of sources covered by a CTG
document as well as each major source of VOCs in ozone nonattainment
areas classified as Moderate or above (see CAA section 182(b)(2)). The
SDCAPCD regulates an ozone nonattainment area that is currently
classified as a ``Severe'' nonattainment area for the 2008 8-hour ozone
National Ambient Air Quality Standard (NAAQS).\1\ Therefore, this rule
must implement RACT. Our action evaluates whether Rule 61.2 implements
RACT for the Tank Truck Gasoline Loading CTG source category.
---------------------------------------------------------------------------

    \1\ 86 FR 29522 (June 2, 2021).
---------------------------------------------------------------------------

    States must submit for SIP approval negative declarations for those
source categories for which they have not adopted CTG-based regulations
(because they have no sources above the CTG-recommended applicability
threshold) regardless of whether such negative declarations were made
for an earlier SIP.\2\ The submittal should provide reasonable
assurance that no sources subject to the CTG requirements currently
exist in the portion of the ozone nonattainment area that is regulated
by the SDCAPCD. Our action evaluates the negative declaration for non-
CTG major VOC sources.
---------------------------------------------------------------------------

    \2\ 57 FR 13498, 13512 (April 16, 1992).
---------------------------------------------------------------------------

    Guidance and policy documents that we used to evaluate
enforceability, revision/relaxation and rule stringency requirements
for the applicable criteria pollutants include the following:

    1. ``State Implementation Plans; General Preamble for the
Implementation of Title I of the Clean Air Act Amendments of 1990,''
57 FR 13498 (April 16, 1992); 57 FR 18070 (April 28, 1992).
    2. ``Issues Relating to VOC Regulation Cutpoints, Deficiencies,
and Deviations,'' EPA, May 25, 1988 (the Bluebook, revised January
11, 1990).
    3. ``Guidance Document for Correcting Common VOC & Other Rule
Deficiencies,'' EPA Region 9, August 21, 2001 (the Little Bluebook).
    4. ``Control of Hydrocarbons from Tank Truck Gasoline Loading
Terminals,'' EPA-450/2-77-026, October 1977.
    5. ``Control of Volatile Organic Emissions from Bulk Gasoline
Plants,'' EPA-450/2-77-035, December 1977.
    6. ``Control of Volatile Organic Compound Leaks from Gasoline
Tank Trucks and Vapor Collection Systems,'' EPA-450/2-78-051,
December 1978.

B. Do the documents meet the evaluation criteria?

    This rule and negative declaration are consistent with CAA
requirements and relevant guidance regarding enforceability, RACT, and
SIP revisions. Specifically, the rule requirements sufficiently ensure
that affected sources

and regulators can consistently evaluate and determine compliance.
Additionally, our analysis finds that Rule 61.2 represents current RACT
for the Tank Truck Gasoline Loading CTG because the rule is as
stringent as the CTG and is generally consistent with requirements in
other air districts for tank truck gasoline loading at bulk terminals.
In addition, our analysis of the District's negative declaration
determined that there are no non-CTG VOC sources that exceed the 100
tpy VOC threshold for Moderate ozone nonattainment areas. The Technical
Support Document (TSD) has more information on our evaluation.

C. The EPA's Recommendations To Further Improve the Submitted Rule

    The TSD includes a recommendation for the next time the local
agency modifies the Rule 61.2.

D. Public Comment and Proposed Action

    As authorized in section 110(k)(3) of the Act, the EPA proposes to
fully approve the submitted Rule 61.2 because it fulfills all relevant
requirements. In addition, the EPA proposes approval of the submitted
negative declaration for non-CTG major VOC sources for 2008 RACT SIP
Moderate area requirements. We will accept comments from the public on
this proposal until July 5, 2022. If we take final action to approve
the submitted rule and negative declaration, our final action will
incorporate this rule into the federally enforceable SIP and stop the
sanctions and FIP clocks that are associated with our previous
disapproval.

III. Incorporation by Reference

    In this rule, the EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by
reference SDCAPCD Rule 61.2, ``Transfer of Organic Compounds into
Mobile Transport Tanks'' as amended on February 10, 2021. The EPA has
made, and will continue to make, these materials available through
https://www.regulations.gov and at the EPA Region IX Office (please
contact the person identified in the FOR FURTHER INFORMATION CONTACT
section of this preamble for more information).

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
proposed action merely proposes to approve state law as meeting federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide the EPA with the discretionary authority
to address disproportionate human health or environmental effects with
practical, appropriate, and legally permissible methods under Executive
Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Reporting and
recordkeeping requirements, Volatile organic compounds.

    Authority:  42 U.S.C. 7401 et seq.

    Dated: May 31, 2022.
Martha Guzman Aceves,
Regional Administrator, Region IX.
[FR Doc. 2022-11971 Filed 6-2-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 72 (Friday, April 13, 2018)]
[Notices]
[Pages 16106-16108]
[FR Doc No: 2018-07687]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1270]

Considerations for Design, Development, and Analytical Validation
of Next Generation Sequencing-Based In Vitro Diagnostics Intended To
Aid in the Diagnosis of Suspected Germline Diseases; Guidance for
Stakeholders and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the final guidance entitled ``Considerations for
Design, Development, and Analytical Validation of Next Generation
Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Intended to Aid in
the Diagnosis of Suspected Germline Diseases; Guidance for Stakeholders
and Food and Drug Administration Staff.'' FDA's vision is that NGS-
based tests can be developed, validated, and offered for clinical use
through a process that leverages appropriate standards, quality systems
controls, and community assessment of clinical validity to streamline
the premarket review process. This guidance provides recommendations
for designing, developing, and establishing analytical performance for
NGS-based tests used for whole exome human DNA sequencing (WES) or
targeted human DNA sequencing intended to aid in the diagnosis of
symptomatic individuals with suspected germline diseases or other
conditions. These recommendations are based on FDA's understanding of
the tools and processes needed to run an NGS-based test along with the
design and analytical validation considerations appropriate for such
tests.

DATES: The announcement of the guidance is published in the Federal
Register on April 13, 2018.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

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-D-1270 for ``Considerations for Design, Development, and
Analytical Validation of Next Generation Sequencing (NGS)-Based In
Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected
Germline Diseases; Guidance for Stakeholders and Food and Drug
Administration Staff.'' Received comments 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 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.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Considerations for Design, Development, and Analytical Validation of
Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs)
Intended to Aid in the Diagnosis of Suspected Germline Diseases;
Guidance for Stakeholders and Food and Drug Administration Staff'' to
the Office of the Center Director, Guidance and Policy Development,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002, or the Office of Communication, Outreach, and
Development, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Zivana Tezak, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4544, Silver Spring, MD 20993-0002,<PHONE_NUMBER>;
or [email protected]; or Adam Berger, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4547, Silver Spring, MD 20993-0002,<PHONE_NUMBER>;
or [email protected]; or Stephen Ripley, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is committed to implementing a flexible and adaptive regulatory
approach to the oversight of NGS-based tests, which will foster
innovation and simultaneously assure that patients have access to
accurate and meaningful test results. FDA held two public workshops on
this issue: ``Optimizing FDA's Regulatory Oversight of Next Generation
Sequencing Diagnostic Tests Public Workshop'' held on February 20,
2015, and ``Standards Based Approach to Analytical Performance
Evaluation of Next Generation Sequencing In Vitro Diagnostic Tests''
held on November 12, 2016.
    This guidance document provides recommendations for designing,
developing, and establishing analytical validity of NGS-based tests
used for WES or targeted human DNA sequencing intended to aid in the
diagnosis of individuals with suspected germline diseases or other
conditions (hereinafter referred to as ``NGS-based tests for germline
diseases'' or ``NGS-based tests''). It also outlines considerations for
possibly classifying certain NGS-based tests for germline diseases in
class II and exempting them from premarket notification requirements.
These recommendations should be used as guidelines for test developers
for premarket submissions. However, the longer term goal is for these
recommendations to form the basis for standards that FDA could
recognize or for special controls and/or conditions for premarket
notification (510(k)) exemption. FDA is also issuing a guidance
entitled ``Use of Public Human Genetic Variant Databases to Support
Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics''
which is being issued concurrently elsewhere in this issue of the
Federal Register.
    On July 8, 2016, FDA announced a draft guidance in the Federal
Register (81 FR 44614) and made available for public comment. The
comment period closed on October 6, 2016. FDA reviewed and considered
all public comments received and revised the guidance, as appropriate.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on considerations for design, development, and
analytical validation of NGS-based IVDs used to aid in the diagnosis of
suspected germline diseases. It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations. This guidance is not subject to Executive
Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov.
Persons unable to download an electronic copy of ``Considerations for
Design, Development, and Analytical Validation of Next Generation
Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Intended to Aid in
the Diagnosis of Suspected Germline Diseases; Guidance for Stakeholders
and Food and Drug Administration Staff'' may send an email request to
[email protected] to receive an electronic copy of the
document. Please use the document number 16009 to identify the guidance
you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 807, subpart E, regarding
premarket notification submissions, have been approved under OMB
control number 0910-0120; the collections of information in 21 CFR part
801 and 21 CFR 809.10, regarding labeling, have been approved under OMB
control

number 0910-0485; the collections of information in 21 CFR part 814,
subparts A through E, regarding premarket approval, have been approved
under OMB control number 0910-0231; the collections of information in
21 CFR part 820, regarding the quality system regulation, have been
approved under OMB control number 0910-0073; and the collections of
information in the guidance document ``Requests for Feedback on Medical
Device Submissions: The Pre-Submission Program and Meetings with Food
and Drug Administration Staff'' have been approved under OMB control
number 0910-0756.

    Dated: April 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07687 Filed 4-12-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 190 (Monday, October 1, 2018)]
[Proposed Rules]
[Pages 49317-49322]
[FR Doc No: 2018-20950]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0801; Product Identifier 2017-NM-147-AD]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc., Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to supersede Airworthiness Directive (AD) 2008-24-
14, which applies to all Bombardier, Inc., Model CL-600-2B19 (Regional
Jet Series 100 & 440) airplanes. AD 2008-24-14 requires revising the
instructions for continued airworthiness to incorporate certain
airworthiness limitations for the main landing gear (MLG) trunnion
fitting assembly. Since we issued AD 2008-24-14, new airworthiness
limitation (AWL) tasks have been introduced with revised inspection,
modification, and safe-life requirements. This proposed AD would
require revising the maintenance or inspection program, as applicable,
to incorporate certain AWLs. It would also require reworking the
trunnion fitting in order to meet new structural safe-life limits. We
are proposing this AD to address the unsafe condition on these
products.

DATES: We must receive comments on this proposed AD by November 15,
2018.

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 NPRM, contact
Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval, Qu[eacute]bec
H4S 1Y9, Canada; Widebody Customer Response Center North America toll-
free telephone 1-866-538-1247 or direct-dial telephone 1-514-855-2999;
fax<PHONE_NUMBER>; email [email protected]; internet http://www.bombardier.com. You may view this referenced service information at
the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines,
WA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0801; 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 NPRM, the regulatory evaluation, any comments received,
and other information. The street address for the Docket Operations
office (telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments
will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Aziz Ahmed, Aerospace Engineer,
Airframe and Mechanical Systems Section, FAA, New York ACO Branch, 1600
Stewart Avenue, Suite 410, Westbury, NY 11590; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

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-2018-0801;
Product Identifier 2017-NM-147-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 based on 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 issued AD 2008-24-14, Amendment 39-15758 (73 FR 73785, December
4, 2008) (``AD 2008-24-14''), for all Bombardier, Inc., Model CL-600-
2B19 (Regional Jet Series 100 & 440) airplanes. AD 2008-24-14 requires
revising the Airworthiness Limitations Section (ALS) of the
Instructions for Continued Airworthiness to incorporate new structural
inspection requirements. AD 2008-24-14 resulted from reports of the
discovery of cracks on the MLG trunnion fitting web during fatigue
testing. We issued AD 2008-24-14 to detect and correct fatigue cracking
of the MLG trunnion fitting web.

Actions Since AD 2008-24-14 Was Issued

    Since we issued AD 2008-24-14, new AWL tasks have been introduced
with revised inspection, modification, and safe-life requirements, and
we have determined that the trunnion fitting lower flange and both
forward and aft bore holes are also subject to fatigue cracking.
    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian Airworthiness Directive CF-
2017-27, dated August 2, 2017 (referred to after this as the Mandatory
Continuing Airworthiness Information, or ``the MCAI''), to correct an
unsafe condition for certain Bombardier, Inc., Model CL-600-2B19
(Regional Jet Series 100 & 440) airplanes. The MCAI states:

    Cracks on the main landing gear (MLG) trunnion fitting web
discovered during fatigue testing led to the issuance of [Canadian]
AD CF-2008-21 [which corresponds to FAA AD 2008-24-14], which
mandated new inspection requirements to ensure that fatigue cracking
of the trunnion web would be detected and corrected.
    Additional fatigue test article findings and in-service findings
have shown that the trunnion fitting lower flange and both forward
and aft bore holes are also subject to fatigue cracking. Failure of
the main landing gear trunnion fitting could result in the collapse
of the main landing gear. Bombardier Inc. has decided to implement a
series of design changes to improve the fatigue life of the trunnion
fitting that is now a safe-life assembly.
    New and revised Airworthiness Limitation (AWL) tasks for the MLG
trunnion fitting assembly have been introduced in order to require
new inspection, modification, and safe-life requirements. This
[Canadian] AD mandates the incorporation of these new and revised
AWL tasks, and removal of the AWL tasks they replace, to ensure that
fatigue cracking of the MLG trunnion fitting is detected and
corrected. This [Canadian] AD also requires rework of the trunnion
fitting in order to meet new structural safe-life limits.

    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-2018-
0801.

Related Service Information Under 1 CFR Part 51

    Bombardier has issued the following service information.
     Bombardier Service Bulletin 601R-57-046, Revision C, dated
December 20, 2012, describes the cold working of fastener holes in the
MLG trunnion fitting, and related investigative and corrective actions.
     Bombardier Service Bulletin 601R-57-047, Revision B, dated
October 2, 2012, describes the installation of forcemate bushings in
the MLG trunnion, and related investigative and corrective actions.
     Bombardier Service Bulletin 601R-57-048, Revision C, dated
June 6, 2013, describes the cold working of holes on the web of the MLG
trunnion, and related investigative and corrective actions.
    These documents are distinct because they apply to different parts
of the airplane.
    The following service information describes certain AWL tasks for
the MLG trunnion fitting assembly.
     Bombardier Maintenance Requirements Manual Temporary
Revision (TR) 2B-2237, dated June 19, 2014.
     Bombardier Maintenance Requirements Manual Temporary
Revision (TR) 2B-2238, dated June 19, 2014.
     Bombardier Maintenance Requirements Manual Temporary
Revision (TR) 2B-2239, dated June 19, 2014.
     Bombardier Maintenance Requirements Manual Temporary
Revision (TR) 2B-2241, dated June 19, 2014.
     Bombardier Maintenance Requirements Manual Temporary
Revision (TR) 2B-2242, dated June 19, 2014.
     Bombardier Maintenance Requirements Manual Temporary
Revision (TR) 2B-2246, dated November 7, 2014.
    These documents are distinct because they describe different
actions. 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.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.
    This proposed AD would require revisions to certain operator
maintenance documents to include new actions (e.g., inspections).
Compliance with these actions is required by 14 CFR 91.403(c). For
airplanes that have been previously modified, altered, or repaired in
the areas addressed by this proposed AD, the operator may not be able
to accomplish the actions described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must request
approval for an alternative method of compliance according to paragraph
(p)(1) of this proposed AD. The request should include a description of
changes to the required actions that will ensure the continued
operational safety of the airplane.

Differences Between This Proposed AD and the Service Information

    The MCAI includes the following statement: ``If it is not possible
to complete all of the instructions in the SBs . . . due to the
configuration of the aircraft, contact Bombardier Inc. for approved
instructions.'' This issue is addressed in 14 CFR 39.17, which states
that ``If a change in a product affects your ability to accomplish the
actions required by the AD in any way, you must request FAA approval of
an AMOC [alternative method of compliance]. . . .'' Since we do not
currently have the authority to delegate AMOC approvals to foreign
civil aviation authorities, the FAA is responsible for these approvals.

Costs of Compliance

    We estimate that this proposed AD affects 460 airplanes of U.S.
registry. We estimate the following costs to comply with this proposed
AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
            Action                 Labor cost       Parts cost    Cost per product     Cost on U.S. operators
----------------------------------------------------------------------------------------------------------------
Retained actions..............  1 work-hour x                 $0  >$85              $39,100.
                                 $85 per hour =
                                 $85.
Rework trunnion bearings (new   Up to 178 work-           38,928  Up to $54,058...  Up to $24,866,680.
 proposed actions).              hours x $85 per
                                 hour = Up to
                                 $15,130.
----------------------------------------------------------------------------------------------------------------

    We have determined that revising the maintenance or inspection
program takes an average of 90 work-hours per operator, although we
recognize that this number may vary from operator to operator. In the
past, we have estimated that this action takes 1 work-hour per
airplane. Since operators incorporate maintenance or inspection program
changes for their affected fleet(s), we have determined that a per-
operator estimate is more accurate than a per-airplane estimate.
Therefore, we estimate the total cost per operator to be $7,650 (90
work-hours x $85 per work-hour).
    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions specified in this proposed
AD.
    According to the manufacturer, some or all of the costs of this AD
may be covered under warranty, thereby reducing the cost impact on
affected individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

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.
    This proposed AD is issued in accordance with authority delegated
by the Executive Director, Aircraft Certification Service, as
authorized by FAA Order 8000.51C. In accordance with that order,
issuance of ADs is normally a function of the Compliance and
Airworthiness Division, but during this transition period, the
Executive Director has delegated the authority to issue ADs applicable
to transport category airplanes to the Director of the System Oversight
Division.

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

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)
2008-24-14, Amendment 39-15758 (73 FR 73785, December 4, 2008), and
adding the following new AD:

Bombardier, Inc.: Docket No. FAA-2018-0801; Product Identifier 2017-
NM-147-AD.

(a) Comments Due Date

    We must receive comments by November 15, 2018.

(b) Affected ADs

    This AD replaces AD 2008-24-14, Amendment 39-15758 (73 FR 73785,
December 4, 2008) (``AD 2008-24-14'').

(c) Applicability

    This AD applies to Bombardier, Inc., Model CL-600-2B19 (Regional
Jet Series 100 & 440) airplanes, certificated in any category,
serial numbers 7002 and subsequent.

(d) Subject

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

(e) Reason

    This AD was prompted by reports of cracks on the main landing
gear trunnion (MLG) fitting during fatigue testing, the introduction
of new airworthiness limitation (AWL) tasks with revised inspection,
modification, and safe-life requirements, and a determination that
the trunnion fitting lower flange and both forward and aft bore
holes are also subject to fatigue cracking. We are issuing this AD
to detect and correct fatigue cracking of the MLG trunnion fitting.
Failure of the MLG trunnion fitting web could compromise the
structural integrity of the trunnion fitting and result in MLG
collapse.

(f) Compliance

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

(g) Retained Revision of Airworthiness Limitation Section With No
Changes

    This paragraph restates the requirements of paragraph (f)(1) of
AD 2008-24-14, with no changes. Within 30 days after December 19,
2008 (the effective date of AD 2008-24-14), revise the Airworthiness
Limitations Section (ALS) of the Instructions for Continued
Airworthiness to incorporate AWL 57-21-161, as identified in
Bombardier Temporary Revision 2B-2136, dated May 1, 2008, to the
Bombardier CL-600-2B19 Maintenance Requirements Manual, Part 2,
Appendix B--Airworthiness Limitations. The initial compliance time
for the task starts from the applicable time specified in table 1 or
table 2 to paragraphs (g) and (j) of this AD, as applicable. Repeat
the inspection thereafter at the applicable interval specified in
Bombardier Temporary Revision 2B-2136, dated May 1, 2008.

[GRAPHIC] [TIFF OMITTED] TP01OC18.000

(h) Retained No Alternative Actions or Intervals With New Exception

    This paragraph restates the requirements of paragraph (f)(2) of
AD 2008-24-14, with a new exception: Except as required by paragraph
(i) of this AD, after accomplishing the actions specified in
paragraph (g) of this AD, no alternative inspections or inspection
intervals may be used unless the inspection or inspection interval
is approved as an alternative method of compliance (AMOC) in
accordance with the procedures specified in paragraph (p)(1) of this
AD.

(i) New Requirement of This AD: Revision of Maintenance or Inspection
Program

    (1) Within 60 days after the effective date of this AD: Revise
the maintenance or inspection program, as applicable, by
incorporating the AWL tasks specified in figure 1 to paragraphs (i)
and (o) of this AD. Except as specified in paragraph (j) of this AD,
the initial compliance times for the tasks are at the applicable
times specified in the temporary revisions (TRs) identified in
figure 1 to paragraph (i) and (o) of this AD, or within 60 days
after the effective date of this AD, whichever occurs later. When
the information in AWL tasks identified in the TRs specified in
figure 1 to paragraphs (i) and (o) of this AD has been included in
the general revisions of Bombardier Maintenance Requirements Manual
(MRM), CSP A-053, Part 2, Appendix B, the general revisions may be
inserted in the MRM, and the TRs may be removed.

[GRAPHIC] [TIFF OMITTED] TP01OC18.001

    (2) Within 60 days after the effective date of this AD: Revise
the maintenance or inspection program, as applicable, by removing
the AWL tasks specified in figure 2 to paragraph (i) of this AD.
[GRAPHIC] [TIFF OMITTED] TP01OC18.002

(j) New Requirement of This AD: Initial Compliance Times for AWL Tasks

    (1) For AWL 57-21-161, the compliance time for the initial
inspection of AWL 57-21-161 is as specified in tables 1 or 2 to
paragraphs (g) and (j) of this AD, as applicable; or within 60 days
after the effective date of this AD, whichever occurs later.
    (2) For AWL 57-21-161, the compliance time for the limitation
section is at the applicable time specified in AWL 57-21-161 or
within 2,000 flight cycles after the effective date of this AD,
whichever occurs later.
    (3) For AWL 57-21-145 and AWL 57-21-155, the compliance times
for the initial inspections are at the applicable times specified in
AWL 57-21-145 and AWL 57-21-155 or within 2,000 flight cycles after
the effective date of this AD, whichever occurs later.

(k) New Requirement of This AD: No Alternative Actions or Intervals

    After the maintenance or inspection program has been revised as
required by paragraph (i) of this AD, no alternative actions (e.g.,
inspections) or intervals may be used unless the actions or
intervals are approved as an alternative method of compliance (AMOC)
in accordance with the procedures specified in paragraph (p)(1) of
this AD.

(l) New Requirement of This AD: Rework of MLG Trunnion To Meet
Structural Safe-Life Limits

    Except as specified in paragraphs (m)(1) and (m)(2) of this AD:
Within the phase-in times specified in paragraphs (j)(2) and (j)(3)
of this AD, rework the MLG trunnion in accordance with the
Accomplishment Instructions of the service information identified in
paragraphs (l)(1) through (l)(3) of this AD, as applicable.
    (1) Bombardier Service Bulletin 601R-57-046, Revision C, dated
December 20, 2012, for the cold working of fastener holes in the MLG
trunnion fitting, and related investigative and corrective actions.
    (2) Bombardier Service Bulletin 601R-57-047, Revision B, dated
October 2, 2012, for the installation of forcemate bushings in the
MLG trunnion, and related investigative and corrective actions.
    (3) Bombardier Service Bulletin 601R-57-048, Revision C, dated
June 6, 2013, for the cold work of holes on the web of the MLG
trunnion, and related investigative and corrective actions.

(m) Exceptions to Rework Requirements

    (1) For airplanes on which Bombardier Service Bulletin 601R-57-
046, Revision A, dated December 21, 2009; or Bombardier Service
Bulletin 601R-57-046, Initial Issue, dated July 17, 2009; was
accomplished prior to the effective date of this AD: Within 6 months
after the effective date of this AD, do Part G of the Accomplishment
Instructions of Bombardier Service Bulletin 601R-57-046, Revision C,
dated December 20, 2012.
    (2) For airplanes on which Bombardier Service Bulletin 601R-57-
048, Revision A, dated November 24, 2009; or Bombardier Service
Bulletin 601R-57-048, Initial Issue, dated July 17, 2009; was
accomplished prior to the effective date of this AD: Within 6 months
after the effective date of this AD, do Part C of the Accomplishment
Instructions of Bombardier Service Bulletin 601R-57-048, Revision C,
dated June 6, 2013.

(n) Credit for Previous Actions

    (1) This paragraph provides credit for actions required by
paragraph (l)(1) of this AD, if those actions were performed before
the effective date of this AD, using Bombardier Service Bulletin
601R-57-046, Revision B, dated August 24, 2012.
    (2) This paragraph provides credit for actions required by
paragraph (l)(2) of this AD, if those actions were performed before
the effective date of this AD, using the service information
specified in paragraph (n)(2)(i) or (n)(2)(ii) of this AD.
    (i) Bombardier Service Bulletin 601R-57-047, Revision A, dated
February 1, 2012.
    (ii) Bombardier Service Bulletin 601R-57-047, Initial Issue,
dated June 29, 2011.
    (3) This paragraph provides credit for actions required by
paragraph (l)(3) of this

AD, if those actions were performed before the effective date of
this AD, using Bombardier Service Bulletin 601R-57-048, Revision B,
dated August 24, 2012.
    (4) This paragraph provides credit for actions required by
paragraph (m)(1) of this AD, if those actions were performed before
the effective date of this AD, using Part G of the Accomplishment
Instructions of Bombardier Service Bulletin 601R-57-046, Revision B,
dated August 24, 2012.
    (5) This paragraph provides credit for actions required by
paragraph (m)(2) of this AD, if those actions were performed before
the effective date of this AD, using Part C of the Accomplishment
Instructions of Bombardier Service Bulletin 601R-57-048, Revision B,
dated August 24, 2012.

(o) Repairs and Alternative Actions or Intervals

    (1) If any damage is found during an inspection required by the
AWLs identified in figure 1 to paragraphs (i) and (o) of this AD,
repair before further flight using a method approved by the Manager,
New York ACO Branch, FAA; or Transport Canada Civil Aviation (TCCA);
or Bombardier, Inc.'s TCCA Design Approval Organization (DAO). If
approved by the DAO, the approval must include the DAO-authorized
signature. The approved repair instructions must specifically refer
to this AD or Canadian AD CF-2017-27, dated August 2, 2017.
    (2) Repairs approved by Bombardier, Inc., that deviate from the
AWLs identified in figure 1 to paragraphs (i) and (o) of this AD are
acceptable methods of compliance if approved by the Manager, New
York ACO Branch, FAA; or TCCA; or Bombardier, Inc.'s TCCA DAO. If
approved by the DAO, the approval must include the DAO-authorized
signature. The approved repair instructions must specifically refer
to this AD or Canadian AD CF-2017-27, dated August 2, 2017.
    (3) For repairs approved before the effective date of this AD
that affect the AWLs identified in figure 1 to paragraphs (i) and
(o) of this AD and the approved repair instructions do not
specifically refer to Canadian AD CF-2017-27, dated August 2, 2017:
Within 6 months of the effective date of this AD, contact the
Manager, New York ACO Branch, FAA; or TCCA; or Bombardier, Inc.'s
TCCA DAO Inc., for new or revised limitations or inspection
requirements on the repair area and comply with the revised
limitations or inspections requirements. The new or revised
limitations or inspection requirements must specifically refer to
this AD or Canadian AD CF-2017-27, dated August 2, 2017.
    (4) Canadian AMOC No. AARDG-2018/A21, dated May 1, 2018, which
was approved before the effective date of this AD by TCCA, is an
acceptable method of compliance to the corresponding requirements of
this AD.

(p) Other FAA AD Provisions

    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York ACO Branch, 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 certification
office, send it to ATTN: Program Manager, Continuing Operational
Safety, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Before
using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
local flight standards district office/certificate holding district
office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, New York ACO
Branch, FAA; or TCCA; or Bombardier, Inc.'s TCCA DAO. If approved by
the DAO, the approval must include the DAO-authorized signature. The
approved corrective action instructions must specifically refer to
this AD or Canadian AD CF-2017-27, dated August 2, 2017.

(q) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) Canadian Airworthiness Directive CF-2017-27, dated August 2,
2017, 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-2018-0801.
    (2) For more information about this AD, contact Aziz Ahmed,
Aerospace Engineer, Airframe and Mechanical Systems Section, FAA,
New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY
11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
    (3) For service information identified in this AD, contact
Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval,
Qu[eacute]bec H4S 1Y9, Canada; Widebody Customer Response Center
North America toll-free telephone 1-866-538-1247 or direct-dial
telephone 1-514-855-2999; fax<PHONE_NUMBER>; email
[email protected]; internet http://www.bombardier.com. You
may view this service information at the FAA, Transport Standards
Branch, 2200 South 216th St., Des Moines, WA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued in Des Moines, Washington, on September 11, 2018.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2018-20950 Filed 9-28-18; 8:45 am]
 BILLING CODE 4910-13-P