[Federal Register Volume 79, Number 205 (Thursday, October 23, 2014)]
[Rules and Regulations]
[Pages 63307-63311]
[FR Doc No: 2014-24697]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-28413; Directorate Identifier 2007-NE-25-AD;
Amendment 39-17993; AD 2014-21-01]
RIN 2120-AA64

Airworthiness Directives; General Electric Company Turbofan
Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are superseding airworthiness directives (ADs) 90-26-01,
91-20-02, and 2009-05-02 for all General Electric Company (GE) CF6-80C2
and CF6-80E1 series turbofan engines. This AD retains the requirements
of those ADs and requires removal of additional fuel manifold part
numbers (P/Ns), additional repetitive inspections, replacement as
required of certain fuel manifold P/Ns and tube (block) clamps, and
replacement of loop clamps. This AD was prompted by a report of an
under-cowl fire caused by a manifold high-pressure fuel leak, and
several additional reports of fuel leaks. We are issuing this AD to
prevent failure of the fuel manifold, which could lead to uncontrolled
engine fire, engine damage, and damage to the airplane.

DATES: This AD is effective November 28, 2014.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of November 28,
2014.

ADDRESSES: For service information identified in this AD, contact
General Electric Company, GE Aviation, Room 285, 1 Neumann Way,
Cincinnati, OH 45215; phone:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
You may view this service information at the FAA, Engine & Propeller
Directorate, 12 New England Executive Park, Burlington, MA. For
information on the availability of this material at the FAA, call (781)
238-7125.

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-2007-
28413; or in person at the Docket Management Facility between 9 a.m.
and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this AD, the regulatory evaluation, any comments
received, and other information. The address for the Docket Office
(phone:<PHONE_NUMBER>) is Document Management Facility, U.S.
Department of Transportation, Docket Operations, M-30, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC
20590.

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

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to supersede AD 90-26-01, Amendment 39-6810 (55 FR 49611,
November 30, 1990), (``AD 90-26-01''), and AD 91-20-02, Amendment 39-
8036 (56 FR 55231, October 25, 1991), (``AD 91-20-02''), and AD 2009-
05-02, Amendment 39-15826 (74 FR 8161, February 24, 2009), (``AD 2009-
05-02''). AD 90-26-01 and AD 91-20-02 applied to all GE CF6-80C2 series
turbofan engines. AD 2009-05-02 applied to all GE CF6-80C2 and CF6-80E1
series turbofan engines. The NPRM published in the Federal Register on
January 17, 2014 (79 FR 3139). The NPRM was prompted by a report of an
under-cowl fire caused by a manifold high-pressure fuel leak and
several additional reports of fuel leaks. The NPRM proposed to retain
the requirements of the superseded ADs: AD 90-26-01 and AD 91-20-02
required removal of certain fuel manifold P/Ns; AD 2009-05-02 required
inspection of certain fuel manifold P/Ns and replacement of certain
consumable components. The NPRM also proposed to require removal of
additional fuel manifold P/Ns, performance of additional initial and
repetitive inspections, replacement as required of certain fuel
manifold P/Ns and tube (block) clamps, and replacement of loop clamps
at each fuel manifold inspection opportunity. We are issuing this AD to
prevent failure of the fuel manifold, which could lead to uncontrolled
engine fire, engine damage, and damage to the airplane.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the NPRM (79
FR 3139, January 17, 2014) and the FAA's response to each comment.

Request To Replace Two Incorrect Part Numbers

    Several commenters requested that we replace two incorrect fuel
manifold P/Ns with the correct P/Ns.
    We agree. We corrected the P/Ns in paragraph (c) of this AD from P/
Ns 1308M31G12 and 1308M32G12 to P/Ns 1303M31G12 and 1303M32G12.

Request To Change and Clarify Compliance Information

    Several commenters requested that we make changes to Table 1 to
paragraph (e) in the NPRM (79 FR 3139, January 17, 2014). Three
commenters requested that we remove the compliance time of six months
because this requirement is unjustified. Two commenters requested that
we remove one row of information due to redundancy. One commenter
requested that we reorder the rows to make the table easier to follow.
    We partially agree. We agree that the table is problematic. A six-
month compliance time was meant to be a ``grace period'' for products
that might have already exceeded the threshold. But, including a
``grace period'' is unnecessary, since AD 2009-05-02, which we are
superseding with this AD, mandates the same requirement. We removed the
six-month compliance time period.
    We disagree with making the other changes as suggested, but did
reword paragraph (e) to this AD to eliminate the tables and clarify the
AD.

Request To Change Definition of Shop Visit

    Several commenters requested that we change the definition of shop
visit to exclude certain maintenance visits because the current
definition forces the replacement of the fuel manifold at the majority
of shop visits.
    We agree. We changed the definition of shop visit for the purposes
of this AD to exclude shop visits for specified types of maintenance.

Request To Allow Reinstallation of Certain P/N Fuel Manifolds During
On-Wing Maintenance

    Virgin Atlantic Airways, Delta Air Lines, AIRDO, and GE requested
that we allow reinstallation of fuel manifolds, P/Ns 1303M31G12,
1303M32G12, 2420M70G01, and 2420M71G01, during on-wing maintenance, and
only mandate removal of these P/Ns during shop visits. The commenters
state that modification of the fuel manifold configuration during on-
wing maintenance is not practicable due to complexity, potential for
maintenance error, and cost compared to replacement during shop visit.
    We agree. The intent of this AD is to require removal of fuel
manifolds, P/Ns 1303M31G12, 1303M32G12, 2420M70G01, and 2420M71G01,
during shop visit, not during on-wing maintenance. We removed the
installation prohibition statement that included these P/Ns.

Request To Exclude Certain Engine Models From Applicability

    Lufthansa Cargo requested that we exclude from the applicability of
this AD certain CF6-80C2 engine models.
    We disagree. All CF6-80C2 engine models are affected by the same
unsafe condition. We did not change this AD.

Request To Change the Focus of This AD, and To Retain and Supersede
Different ADs

    KLM Royal Dutch Airlines (KLM) requested that we address pigtail
cracking in this AD, instead of tube (block) clamp and loop clamp
chafing, by retaining AD 2009-05-02, Amendment 39-15826 (74 FR 8161,
February 24, 2009), AD 91-20-02, Amendment 39-8036 (56 FR 55231,
October 25, 1991), and AD 90-26-01, Amendment 39-6810 (55 FR 49611,
November 30, 1990), and by superseding AD 2007-11-20, Amendment 39-
15077 (72 FR 30956, June 5, 2007). KLM states that the recent under-
cowl fire event was related to pigtail cracking, which the FAA has not
addressed, and not to tube (block) and loop clamp chafing.
    We disagree. Pigtail cracking, tube (block) clamp chafing, and loop
clamp chafing can all be caused by resonant vibration within the engine
operation range. This AD requires removal of fuel manifolds susceptible
to resonant vibration, which addresses pigtail cracking, tube (block)
clamp chafing, and loop clamp chafing leading to fuel manifold leaks.
We did not change this AD.

Request To Remove From Paragraph (e)(2) Reference to ``Tube (Block)
Clamp''

    KLM requested that we delete reference to the ``Tube (Block)
Clamp'' from paragraph (e)(2) of this AD because instructions regarding
inspection and replacement of the tube (block) clamp are not addressed
in that paragraph.

    We partially agree. The reference to the ``Tube (Block) Clamp'' in
paragraph (e)(2) is inaccurate. We restructured the compliance
paragraphs. Paragraphs (e)(2)(ii) and (e)(2)(iii) of this AD now
reference ``Tube (Block) Clamp.''

Request To Provide More Information Regarding the Unsafe Condition

    Lufthansa Technik AG and Deutsche Lufthansa AG requested that we
provide additional details concerning the unsafe condition.
    We partially agree. Although the AD Discussion section provides
sufficient information regarding the fuel manifold leaks, we included a
reference to additional information in the Related Information
paragraph of this AD.

Request To Expand Compliance To Address Other Unsafe Conditions

    One commenter requested that we expand the compliance requirements
of this AD to address other possible unsafe conditions in the designs
of the accessory gearbox, spray shield, and fuel nozzle, and made
reference to National Transportation Safety Board (NTSB) safety
recommendations (SRs) A-13-022 and A-12-047.
    We disagree. Unsafe conditions in the engine caused by designs of
the accessory gearbox and spray shield are not the subjects of this AD.
Fire caused by fuel manifold leak is the subject of this AD. SRs A-13-
022 and A-12-047 do not address fire caused by fuel manifold leaks. We
did not change this AD.

Request To Allow Use of Future Revisions of Referenced Service
Bulletins (SBs)

    Delta Air Lines requested that we allow use of future revisions of
the SBs referenced in compliance paragraphs because this would
eliminate the need to request an alternative method of compliance
(AMOC) if the SBs are revised.
    We disagree. We are authorized to mandate use of procedures in SBs
that are published and which we have reviewed. Since future revisions
of SBs are not yet published, we are not authorized to mandate their
use in advance. We did not change this AD.

Request To Address Repetitive Inspections of Fuel Manifolds Repaired
With PTFE-Coated Para-Aramid Tape

    Japan Airlines requested that we allow repetitive inspections of
fuel manifolds that have PTFE-coated para-aramid tape at the tube
(block) clamp locations. The NPRM (79 FR 3139, January 17, 2014)
addressed initial inspections, but did not address repetitive
inspections of fuel manifolds repaired with PTFE-coated para-aramid
tape.
    We agree. We changed the references to SBs in this AD to more
recent versions that allow repetitive inspections of fuel manifolds
that have PTFE-coated para-aramid tape at the tube (block) clamp
locations.

Request To Require the Use of GE Method To Replace Fuel Manifolds

    Boeing Commercial Airplanes and another commenter requested that we
require that manifolds be replaced using the method stated in the GE
SBs. To substantiate the request, the second commenter referred to NTSB
SR A-13-028.
    We disagree. The regulations require that operators use acceptable
methods, techniques, and practices to replace the fuel manifolds. The
GE SBs contain one acceptable method to replace the fuel manifolds, but
not the only acceptable method of doing so. We did not change this AD.

Request To Clarify Certain Preamble and Compliance Paragraphs

    GE requested that we clarify, in the ``Proposed AD Requirements''
paragraph, the additional P/Ns of fuel manifolds to be inspected and
replaced. GE also requested that we make clear, in the ``Summary''
paragraph, that on-wing replacement of tube (block) clamps and fuel
manifolds is based on inspection results. GE also requested that we use
alternative wording in paragraph (e) and Table 2 to paragraph (e) of
this AD.
    We partially agree. We agree that we needed to clarify the P/Ns to
be removed before further flight, and those to be inspected until
removed. We changed this AD to clearly identify both groups. We also
agree that paragraph (e) of this AD required clarification. We reworded
paragraph (e) of this AD to clearly identify the requirements to
correct the unsafe condition.

Request To Allow Installation of Certain Prohibited P/Ns

    Asiana Airlines, EVA Airways, Thai Airways, AIRDO, and Japan
Airlines requested that for fuel manifold, P/Ns 1303M31G12, 1303M32G12,
2420M70G01, and 2420M71G01, we reduce the inspection interval or
require non-destructive inspection at shop visits rather than require
removal and prohibit installation. The operators state that their
records do not indicate that these parts cause leaks or experience wear
that would cause their replacement, and they expressed concerns that
the reliability of the replacement fuel manifolds is lower than that of
the prohibited fuel manifolds.
    We disagree. A reduced inspection interval does not prevent pigtail
cracking between shop visits. Our data does not justify a reduced
inspection interval to prevent fuel leak events, or indicate that the
new fuel manifold design has lower reliability. We did not change this
AD.

Request To Allow Use of Certain P/Ns for Drained Engine Configurations

    Lufthansa Technik AG requested that we allow the use of fuel
manifold, P/Ns 2420M70G01, 2420M71G01, 1303M31G12, and 1303M32G12, as
replacement parts for drained (pre SB 73-0253) engine configurations.
The commenter states that GE's service information allows use of fuel
manifold, P/Ns 1303M31G12 and 1303M32G12, on engines with drain system
installed, and this AD does not prohibit installation of fuel manifold,
P/Ns 1303M31G10 and 1303M32G10.
    We disagree. We have no data showing that drainless fuel manifolds
installed in engines with a drain system are more reliable than when
installed in engines with a drainless system. We did not change this
AD.

Request To Remove Certain Fuel Manifolds From Applicability

    Lufthansa Cargo requested that we remove from the applicability of
this AD drainless fuel manifolds to which PTFE-coated para-aramid tape
was applied and the loop and tube (block) clamps were inspected.
    We disagree. We received several reports of fuel leaks and a report
of under-cowl fire. The inspections alone required by this AD do not
address pigtail cracking leading to fuel leaks, and therefore do not
provide an acceptable level of safety. We did not change this AD.

Request To Remove the Word ``Uncontrolled'' From the Description of
Fire

    Boeing Commercial Airplanes requested that we remove from the
preamble the word ``uncontrolled'' from the description of fire caused
by a fuel manifold leak because an uncontrolled fire in this scenario
could only occur with a significant failure of the engine nacelle fire
protection system.
    We disagree. The data upon which we relied, including the Continued
Airworthiness Assessment Methodologies (CAAM) database for transport
category airplanes, includes data showing flammable fluid leaks leading
to uncontrolled fires. We did not change this AD.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this AD with the changes described previously and editorial changes to
improve clarity. We have determined that these changes:
     Are consistent with the intent that was proposed in the
NPRM (79 FR 3139, January 17, 2014) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (79 FR 3139, January 17, 2014).
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of this AD.

Costs of Compliance

    We estimate that this AD would affect 1,126 engines installed on
airplanes of U.S. registry. We also estimate that required parts cost
about $34,894 per engine. We also estimate that it will take about 6
hours to accomplish the actions required by this AD. The average labor
rate is $85 per hour. Based on these figures, we estimate the total
cost of this AD to U.S. operators to be $39,864,904.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by:
0
a. Removing airworthiness directive (AD) 90-26-01, Amendment 39-6810
(55 FR 49611, November 30, 1990); AD 91-20-02, Amendment 39-8036 (56 FR
55231, October 25, 1991); and AD 2009-05-02, Amendment 39-15826 (74 FR
8161, February 24, 2009); and
0
b. Adding the following new AD:

2014-21-01 General Electric Company: Amendment 39-17993; Docket No.
FAA-2007-28413; Directorate Identifier 2007-NE-25-AD.

(a) Effective Date

    This AD is effective November 28, 2014.

(b) Affected ADs

    This AD supersedes AD 90-26-01, Amendment 39-6810 (55 FR 49611,
November 30, 1990); AD 91-20-02, Amendment 39-8036 (56 FR 55231,
October 25, 1991); and AD 2009-05-02, Amendment 39-15826, (74 FR
8161, February 24, 2009).

(c) Applicability

    This AD applies to all General Electric Company (GE) CF6-80C2
and CF6-80E1 series turbofan engines with fuel manifold, part number
(P/N) 1303M31G04, 1303M32G04, 1303M31G06, 1303M32G06, 1303M31G07,
1303M32G07, 1303M31G08, 1303M32G08, 1303M31G12, 1303M32G12,
2420M70G01, or 2420M71G01, installed.

(d) Unsafe Condition

    This AD was prompted by a report of an under-cowl fire caused by
a fuel manifold high-pressure fuel leak, and several additional
reports of fuel leaks. We are issuing this AD to prevent failure of
the fuel manifold, which could lead to uncontrolled engine fire,
engine damage, and damage to the airplane.

(e) Compliance

    Comply with this AD within the compliance times specified,
unless already done.
    (1) Fuel Manifold Removal.
    (i) After the effective date of this AD, do not return to
service any CF6-80C2 or CF6-80E1 series engine with fuel manifold P/
N 1303M31G04, 1303M32G04, 1303M31G06, 1303M32G06, 1303M31G07,
1303M32G07, 1303M31G08, or 1303M32G08, installed.
    (ii) At the next engine shop visit after the effective date of
this AD, remove from service fuel manifold P/Ns 1303M31G12,
1303M32G12, 2420M70G01, and 2420M71G01.
    (2) Fuel Manifold, Loop Clamp, and Tube (Block) Clamp Initial
and Repetitive Inspection and Replacement.
    (i) For CF6-80C2 and CF680E1 series engines, with fuel manifold,
P/N 1303M31G12, 1303M32G12, 2420M70G01, or 2420M71G01 installed,
inspect the fuel manifold and replace if required by inspection
results, and replace the loop clamps as follows:
    (A) For CF6-80C2 series engines, use paragraphs 3.A, 3.C, and
3.D of GE CF6-80C2 Service Bulletin (SB) No. S/B 73-0326 R04,
Revision 4, dated December 23, 2009, to do the inspection and
replacements.
    (B) For CF6-80E1 series engines, use paragraphs 3.A, 3.B, and
3.C of GE CF6-80E1 SB No. S/B 73-0061 R04, Revision 4, dated
December 23, 2009, to do the inspection and replacements.
    (C) Compliance time for fuel manifold inspection and loop clamp
replacement:
    (1) If the engine is a first-run engine, inspect the fuel
manifold and replace the loop clamps within 7,500 flight hours (FH)
time-since-new (TSN).
    (2) If the engine's fuel manifold was ever inspected and new
loop clamps were previously installed, inspect the fuel manifold and
replace the loop clamps within 7,500 FH time-since-last-inspection
(TSLI).
    (3) If the engine's fuel manifold was not inspected, new loop
clamps were not installed, or it is unknown when the loop clamps
were installed, inspect the fuel manifold and replace the loop
clamps within 1,750 FH time-since-last-shop-visit or within 4 months
after the effective date of this AD, whichever occurs later.
    (ii) For CF6-80C2 and CF6-80E1 series engines, with fuel
manifold, P/N 1303M31G12, 1303M32G12, 2420M70G01, or 2420M71G01,
with tube (block) clamp, P/N 1153M26G15, installed, inspect fuel
manifold and tube (block) clamps, and replace if required by
inspection results, as follows:
    (A) For CF6-80C2 series engines, use paragraphs 3.A.(1) through
3.A.(8) and 3.C.(1) through 3.C.(2) of GE CF6-80C2 SB No. S/B 73-
0414, Revision 1, dated May 29, 2014, to do the inspection.
    (B) For CF6-80E1 series engines, use paragraphs 3.A.(1) through
3.A.(6) and 3.C.(1)

through 3.C.(2) of GE CF6-80E1 SB No. S/B 73-0121, Revision 1, dated
May 29, 2014, to do the inspection.
    (C) Compliance time for fuel manifold and tube (block) clamp
inspection:
    (1) If the engine is a first-run engine, inspect the fuel
manifold and tube (block) clamps within 7,500 FH TSN or within 3
months after the effective date of this AD, whichever occurs later.
    (2) If the engine was previously inspected using either of GE
CF6-80C2 SB No. S/B 73-0414, Revision 1, dated May 29, 2014, or GE
CF6-80E1 SB No. S/B 73-0121, Revision 1, dated May 29, 2014, or
earlier versions, then inspect the fuel manifold and tube (block)
clamps within 7,500 FH TSLI or within 3 months after the effective
date of this AD, whichever occurs later.
    (3) If the engine is not a first-run engine and was not
previously inspected using GE CF6-80C2 SB No. S/B 73-0414, Revision
1, dated May 29, 2014, or GE CF6-80E1 SB No. S/B 73-0121, Revision
1, dated May 29, 2014, or earlier versions, then inspect the fuel
manifold and tube (block) clamps within 7,500 FH TSN or within 3
months after the effective date of this AD, whichever occurs later.
    (iii) Thereafter, inspect fuel manifold, P/Ns 1303M31G12,
1303M32G12, 2420M70G01, and 2420M71G01, and tube (block) clamps,
replace if required by inspection results, and replace the loop
clamps within every 7,500 FH TSLI, using paragraphs (e)(2)(i)(A),
(e)(2)(i)(B), (e)(2)(ii)(A), and (e)(2)(ii)(B) of this AD, as
applicable.

(f) Definition

    (1) For the purposes of this AD, an engine shop visit is the
induction of an engine into the shop where the separation of a major
engine flange occurs, except that induction into the shop for any of
the reasons in paragraphs (f)(i) through (f)(iv) of this AD is not
an engine shop visit:
    (i) Induction of an engine into a shop solely for removal of the
compressor top or bottom case for airfoil maintenance, or for
variable stator vane bushing replacement;
    (ii) Induction of an engine into a shop solely for replacement
of the turbine rear frame;
    (iii) Induction of an engine into a shop solely for replacement
of the accessory gearbox or transfer gearbox, or both; or
    (iv) Induction of an engine into a shop solely for core
vibration trim balance procedure that requires separation of a major
engine flange.
    (2) For the purposes of this AD, a first-run engine is an engine
that has not had a shop visit since entering service.

(g) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Engine Certification Office, FAA, may approve
AMOCs for this AD. Use the procedures found in 14 CFR 39.19 to make
your request.
    (2) Previously approved AMOCs for AD 2009-05-02 (74 FR 8161,
February 24, 2009) remain approved for the corresponding
requirements of paragraphs (e)(1) and (e)(2) of this AD.

(h) Related Information

    (1) For more information about this AD, contact Kasra Sharifi,
Aerospace Engineer, Engine Certification Office, FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington,
MA. 01803; phone<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) For additional details of the under cowl fire that prompted
this AD, refer to National Transportation Safety Board (NTSB) safety
recommendation (SR) A-13-028. The NTSB SR is available on the
Internet at http://www.ntsb.gov/doclib/recletters/2013/A-13-028.pdf.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) General Electric Company (GE) CF6-80C2 Service Bulletin (SB)
No. 73-0326 R04, Revision 4, dated December 23, 2009.
    (ii) GE CF6-80C2 SB No. S/B 73-0414, Revision 1, dated May 29,
2014.
    (iii) GE CF6-80E1 SB No. 73-0061 R04, Revision 4, dated December
23, 2009.
    (iv) GE CF6-80E1 SB No. S/B 73-0121, Revision 1, dated May 29,
2014.
    (3) For GE service information identified in this AD, contact
General Electric Company, GE Aviation, Room 285, 1 Neumann Way,
Cincinnati, OH 45215; phone:<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (4) You may view this service information at the FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington,
MA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.
    (5) You may view this service information at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call<PHONE_NUMBER>, or go
to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Burlington, Massachusetts, on October 7, 2014.
Kim Smith,
Acting Directorate Manager, Engine & Propeller Directorate, Aircraft
Certification Service.
[FR Doc. 2014-24697 Filed 10-22-14; 8:45 am]
BILLING CODE 4910-13-P


MEMORANDUM DATE: December, 2005 SUBJECT: Discussions Regarding Secondary Air System Usage at 20 ° F with European Automotive Manufacturers and Suppliers of Secondary Air Systems FROM: Antonio Fernandez, Engineer Assessment and Standards Division TO: Docket EPA HQ OAR 2005 0036 We contacted representatives of several European automotive manufacturers to obtain additional information on the feasibility of utilizing these systems at temperatures below freezing. The automotive manufacturers have indicated that many of their vehicles sold in the United States ( US) that are equipped with secondary air systems do in fact operate at 20 ° F due to the existing European  6 ° C ( 20 ° F) emission requirements. The engineering staff at these companies is familiar with the operational requirements of the secondary air injection system at temperatures below freezing. While the vehicles may have originally been equipped with a secondary air system to comply with emissions at 75 ° F, the systems have been adapted for use at other cold start temperatures including 20 ° F. European manufacturers indicated that not all of their vehicles have required secondary air injection systems to comply with current US and or European emission standards including the  6 ° C ( 20 ° F) European requirement. These manufacturers indicated that with proper secondary air system design and integration into the vehicle emission control system, no operational issues have been observed in the field attributed to the use of secondary air injection at 20 ° F.

We also contacted sales and applications engineering representatives from the major manufacturers of the secondary air injection systems and individual components of these systems. These manufactures supply the majority of secondary air systems or individual components of these systems to automotive manufacturers for vehicles sold throughout the world. The manufacturers included:

 Borg Warner  Bosch  Denso  Pierburg In discussions with these suppliers about the operational capabilities of the secondary air systems or components of these systems at cold starts below freezing, no manufacturer stated that their systems or components lacked the ability to operate at temperatures below freezing. In fact, some mentioned that they test and perform durability at temperatures well below freezing in addition to supplying secondary air systems or components to European market sold vehicles that currently operate these systems at  7 ° C ( 20 ° F) to meet the European cold emission requirements. Consistent with comments from the European automotive manufacturers, these suppliers indicated that proper secondary air system design and implementation is a requirement for proper system operation and durability. Issues such as water condensation resulting in ice formation in the secondary air system have been addressed through proper secondary air injection system integration into the vehicle such as:

 Providing clean dry air feed to the pump from the air cleaner assembly.  Locating and routing of the pump and air lines to prevent water traps.  Properly selecting and locating the air control valve to prevent exhaust condensation issues.

The careful consideration of these design criteria when implementing a secondary air system has resulted in robust operation of the systems at start temperatures including 20 ° F as demonstrated by the European manufacturers.


[Federal Register Volume 81, Number 189 (Thursday, September 29, 2016)]
[Notices]
[Page 66951]
[FR Doc No: 2016-23543]

=======================================================================
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL16-110-000]

Southwest Power Pool, Inc.; Notice of Institution of Section 206
Proceeding and Refund Effective Date

    On September 23, 2016, the Commission issued an order in Docket No.
EL16-110-000, pursuant to section 206 of the Federal Power Act (FPA),
16 U.S.C. 824e (2012), instituting an investigation into whether
section 34.6 of the Open Access Transmission Tariff of Southwest Power
Pool, Inc. may be unjust, unreasonable, unduly discriminatory or
preferential. Southwest Power Pool, Inc., 156 FERC ] 61,217 (2016).
    The refund effective date in Docket No. EL16-110-000, established
pursuant to section 206(b) of the FPA, will be the date of publication
of this notice in the Federal Register.
    Any interested person desiring to be heard in Docket No. EL16-110-
000 must file a notice of intervention or motion to intervene, as
appropriate, with the Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426, in accordance with Rule 214 of the
Commission's Rules of Practice and Procedure, 18 CFR 385.214, within 21
days of the date of issuance of the order.

    Dated: September 23, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-23543 Filed 9-28-16; 8:45 am]
BILLING CODE 6717-01-P


MEMORANDUM

To:	Margaret Sheppard, U.S. EPA

CC:	Bella Maranion, Melissa Fiffer, and Carolyn Hayek, U.S. EPA

From:	Rebecca Ferenchiak, Jenny Tanphanich, Neha Mukhi, and Mark Wagner,
ICF International

Date:	August 1, 2011

Re:	Additional End-Use Modeling for Household Refrigerators and Freezers

(EPA Contract Number EP-W-10-031 Task Order 005, Task 01)

ICF has reviewed the public comment submitted by Honeywell
(EPA-HQ-OAR-2009-0286-0170.1) in response to EPA’s proposed SNAP
ruling which approves the use of hydrocarbon refrigerants in
refrigerators ([EPA-HQ-OAR-2009-0286; FRL-9147-9] RIN 2060-AP54). In the
comment, Honeywell specifically notes that in EPA’s risk screen for
isobutane in household refrigerators and freezers, the flammability risk
for isobutane is underestimated. To support this notion, Honeywell
performed leak testing of an isobutane refrigerator and provided the
test results in their comment. In this memorandum, ICF examines the
impact of using more conservative assumptions in the flammability
assessment for isobutane and R-441A to determine whether a flammability
risk exists.

Please contact Mark Wagner at<PHONE_NUMBER> with any questions or
comments.

Background

In Comment EPA-HQ-OAR-2009-0286-0170.1(FRL-9147-9, RIN 2060-AP54),
Honeywell states that EPA underestimated the flammability risks
associated with the use of isobutane as a refrigerant in household
refrigerators and freezers. Consequently, ICF, at the request of EPA,
has revisited the end-use modeling performed for both substitutes
proposed for use in household refrigeration, isobutane and R-441A, and
performed an additional flammability analysis and threshold analysis.

Discussion of End-Use Scenarios Modeled

ICF reviewed the assumptions made in the original risk screens for
isobutane and R-441A (formerly known as HCR-188C1), dated May 22, 2009
and November 6, 2009 respectively, to determine whether they were
sufficiently conservative to represent a reasonable worst-case scenario.
 The assumptions used in the original risk screens for worst-case
scenario modeling are summarized in Table 1.

Table 1. Worst-Case Scenario Model Assumptions in Risk Screen

Parameter	Risk Screen Assumptions: Isobutane	Risk Screen Assumptions:

R-441A

Appliance	Household Refrigerator	Household Refrigerator

Room	Household Kitchen	Household Kitchen

Charge size (g)	50	40

Percentage of Charge Leaked 	100%	100%

Length of release (minutes)	1	1

Room size (volume - m3)	18	18

Room ventilation (air changes per hour)	2.5	2.5

Horizontal stratification	95% in bottom 0.4 m (~16 in) of room	95% in
bottom 0.4 m (~16 in) of room

Charge Size

The charge sizes originally modeled for isobutane and R-441A were 50g
and 40g, respectively.  These values were chosen for modeling based on
statements in the SNAP submissions for these substitutes that indicated
the intended charge sizes to be used in appliances.

There is the potential to be more conservative in the setting of this
parameter for additional flammability analysis, since EPA’s proposed
rule allows a household refrigerator to have a charge size of up to 57g.
 The proposed rule also effectively requires that the charge size be
consistent with the standard UL 250 Supplement SA, which calls for a
maximum leak amount of 50 grams for refrigerants with flammability
limits and a heat of combustion greater than 19,000 kJ/kg, such as
isobutane or R-441A. However, the test to determine leak amounts is not
documented in the UL 250 Standard and could potentially be administered
incorrectly.  As a result, in the additional flammability analysis
(described in the following section) ICF uses a leak amount of 57g as a
more conservative assumption for purposes of additional flammability
analysis.

Room Size

In the original risk screen analysis, a kitchen with a floor area of 7.4
m2 and a ceiling height of 2.4 m was assumed (EPA, 1994).  This is
equivalent to a volume of 18 m3. Although very limited data are
available regarding the distribution of kitchen volumes in the United
States, an analysis by Murray (1997) which aggregated data from over 60
different projects reported the minimum kitchen volume encountered as 31
m3.  Further, only one percent of houses sampled had a kitchen smaller
than 53 m3.  Therefore, ICF does not believe there is a need to be more
conservative in the setting of this parameter for the purpose of the
additional flammability analysis.

Room ventilation

The range of potential flow rates for a residential kitchen is believed
to be 2.5 to 4.5 air changes per hour (ACH) (Sheldon 1989).  The more
conservative rate of 2.5 ACH was used in the analyses, and ICF does not
believe there is a need to be more conservative in the setting of this
parameter for the purpose of additional flammability analysis.

Horizontal Stratification

In the original risk screen, it was assumed that horizontal
stratification will occur since both isobutane and R-441A are denser
than air and as a result, settle in higher concentrations closer to the
ground.  In order to simulate the horizontal concentration gradient that
will occur because of the weight differential between the refrigerant
and air, ICF assumed that 95 percent of the leaked refrigerant mixes
evenly into the bottom 0.4 meters of the room, and the remainder of the
refrigerant mixes evenly in the remaining volume (Kataoka 1999).

There is the potential to be more conservative in the setting of this
parameter for additional flammability analysis, since the release point
for a refrigerant may vary with the type of appliance in use.  To
capture the scenario of a bottom-freezer refrigerator, which would
likely have the lowest release point, this flammability analysis will
assume that 95 percent of the leaked refrigerant mixes evenly into the
bottom 0.22 meters (~ 9 inches) of the room, and the remainder of the
refrigerant mixes evenly in the remaining volume.

Additional Flammability Analysis and Results

Table 2 details the assumptions that will be used for the additional
analyses of flammability risks associated with the use of isobutane or
R-441A in the household refrigeration end-use.

Table 2. Assumptions for the Additional Worst-Case Scenario Flammability
Analysis

Parameter	New Assumption

Refrigeration Unit	Household Refrigerator

Room	Household Kitchen

Leak Amount (g)	57*

Length of release (minutes)	1

Room size (volume - m3)	18

Room ventilation (air changes per hour)	2.5

Horizontal stratification	95% in bottom 0.22 m (~9 in) of room*

*More conservative than the assumption used in the original risk
screens.

Based on the re-analysis, assumptions are the same as those modeled in
the original risk screen, with the exception of the charge size
(increased to 57g) and the stratification level assumptions (95% of the
refrigerant will settle into the bottom 0.22 m [~9 in.] of the room).
The results of this secondary analysis for isobutane and R-441A compared
to the results of the original analysis are shown in Table 3.

Table 3. Maximum Concentrations in Lower Compartment of Kitchen

Proposed Substitute	Maximim Concentration: Original Assumptionsa (ppm)
Maximum Concentration:

 Conservative Assumptionsb (ppm)

Isobutanec	6,647	13,778

R-441Ad	6,236	16,153

a See Table 1

b See Table 2

c Isobutane LFL is 18,000 ppm

d R-441A LFL is 16,800 ppm

Although the concentrations in the lower compartment of the kitchen
increased for both isobutane and R-441A after using more conservative
charge size and stratification assumptions, the maximum concentrations
remained below the LFL for both compounds. The maximum concentration for
R-441A is within 95% of the LFL (16,800 ppm); however, it is unlikely
that concentrations would reach these levels using either refrigerant in
a real-life leak situation, due to the conservative nature of the
assumptions. As noted previously, it is unlikely that a kitchen size
would be 18 m3 and that the entire 57 gram charge would leak.

Threshold Analysis and Results

A threshold analysis was also performed to assess the impact of
differences in room volume and leak amount and to determine the needed
parameter values for leaked concentrations to reach the LFL for
isobutane and R-441A.  One of the two assumptions in the revised
flammability analysis (i.e., room size and leak amount) was changed
while the other assumptions remained constant (see Table 2) to determine
the value at which concentrations in the lower compartment of the
kitchen would reach the LFL for isobutane and R-441A.  The results of
the threshold analysis are shown in Table 4.

Table 4.  Room volumes and leak amounts necessary to reach LFL

Refrigerant a,b	Room Size (Volume)	Leak Amount

Isobutane	18 m3	75 g

Isobutane	13.8 m3	57g

R-441A	18 m3	59 g

R-441A	17.3 m3	57g

a Lower Flammability Limit of isobutane is equal to 18,000 ppm.

b Lower Flammability Limit of R-441A is equal to 16,800 ppm..

Assuming a room volume of 18 m3, the charge sizes required for the
concentration in the lower compartment of the kitchen to reach the LFL
for isobutane and R-441A were 75 grams and 59 grams, respectively. Based
on the proposed SNAP ruling, the charge sizes required to reach the LFL
would not be allowed for household refrigerators. Further, although a
charge size of 59 grams for R-441A is close to the allowable 57 gram
charge size, the UL Standard 250 requires that if a charge size of 57
grams is used, engineering controls must be in place to ensure that only
50 grams (or approximately 88%) can leak from the system.

If the charge size of 57 grams was held constant, kitchen volumes of
13.8 m3 (487 ft3) and 17.3 m3 (611 ft3) would be necessary for isobutane
and R-441A concentrations, respectively, in the lower compartment of the
kitchen to reach the LFL. Both threshold kitchen volumes are lower than
the original assumed kitchen volume of 18 m3. However, as noted
previously, it is highly unlikely that a kitchen would exist at such
small volumes—only one percent of houses sampled in more than 60
different projects had a kitchen smaller than 53 m3 (Murray 1997).

Additional Discussion

Depending on the mixing conditions, it is still possible that in certain
locations at floor-level, or in restricted areas such as a space between
a refrigerator and a wall, the concentrations of isobutane or R-441A
could reach their LFLs for a few minutes, posing a threat in the
presence of a spark. However, the annual probability of an external leak
occurring over the course of minutes and an ignition source being
present simultaneously is approximately 5.0 x 10-7 (i.e., 0.5 in one
million) (A.D. Little 1991).

To avoid the risk of fire and explosion, it is recommended that
refrigerators containing isobutane or R-441A not be installed in small,
poorly ventilated spaces such as very small enclosed ‘galley’
kitchens or storage closets (especially as other equipment or appliances
in the space would reduce the effective volume of the room).  For
full-sized kitchens and for kitchens with typical ventilation levels,
the risk of fire and explosion is minimal.

References

A.D. Little 1991.  Risk Assessment of Flammable Refrigerants for Use in
Home Appliances. Arthur D. Little, Inc. for EPA, Climate Change
Division.  September 10, 1991.  Docket item EPA-HQ-OAR-2009-0286-0023.

EPA 1994.  Significant New Alternatives Policy Technical Background
Document:  Risk Screen on the Use of Substitutes for Class I
Ozone-depleting Substances: Refrigeration and Air Conditioning.
Stratospheric Protection Division.  March, 1994.

EPA 2009. Risk Screen on Substitutes for CFC-12 in Household
Refrigerators and Freezers: Isobutane. Stratospheric Protection
Division. Prepared by ICF International. March 2009.

Honeywell 2010. Honeywell International, Inc. Comment on EPA Proposed
Rule. Protection of Stratospheric Ozone: Listing of Substitutes for
Ozone-Depleting Substances-Hydrocarbon Refrigerants.
EPA-HQ-OAR-2009-0286; FRL-9147-9. July, 2010.

Kataoka.  1999.  “Allowable Charge Limit of Flammable Refrigerants and
Ventilation Requirements.”  Draft Proposal.  O. Kataoka/Daikin/Japan,
June, 1999.

Murray, D.M.  1997.  “Residential House and Zone Volumes in the United
States: Empirical and Estimated Parametric Distributions.”  Risk
Analysis.  17(4): 439-446.

Sheldon, L.S., et al.  1989. "An Investigation of Infiltration and
Indoor Air Quality."  New York State Energy Research & Development
Authority, Report 90-11.

UL. 2000. UL 250: Standard for Household Refrigerators and Freezers.
Underwriters Laboratory.

 Murray (1997) uses data from the Brookhaven National Laboratory PFT
database.  Data regarding kitchen volumes were only available for the
Los Angeles area and the kitchen volumes are for a “kitchen zone”
which may include associated areas, such as utility rooms, dining rooms,
living rooms, and family room.  The inclusion of these other spaces in
the “kitchen zone” volume is realistic, as the presence of adjoining
rooms would increase the volume into which the refrigerant could leak.

 This value is consistent with the location for a potential leak from
the condenser-compressor department for a bottom freezer depicted in
comment EPA-HQ-OAR-2009-0286-0170.1.

 Enclosed galley kitchens are kitchens that are not open to the rest of
the dwelling, generally have two (or occasionally three) sides, and have
a pass way or doorway entrance, but no door.

-  PAGE  2 -


[Federal Register Volume 87, Number 126 (Friday, July 1, 2022)]
[Notices]
[Pages 39573-39575]
[FR Doc No: 2022-14066]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-95165; File No. SR-FINRA-2022-017]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing of a Proposed Rule Change To Amend
FINRA Rule 6750 Regarding the Publication of Aggregated Transaction
Information on U.S. Treasury Securities

June 27, 2022.
    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 June 23, 2022, the Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by FINRA. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    FINRA is proposing to amend FINRA Rule 6750 to provide that FINRA
may publish or distribute aggregated transaction information and
statistics on U.S. Treasury Securities on a more frequent basis.
    The text of the proposed rule change is available on FINRA's
website at http://www.finra.org, at the principal office of FINRA 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, FINRA included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. FINRA 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
    On July 10, 2017,\3\ FINRA members began reporting information on
transactions in U.S. Treasury Securities \4\ to the Trade Reporting And
Compliance Engine (TRACE).\5\ Information reported to TRACE regarding
individual transactions in U.S. Treasury Securities is used for
regulatory and other official sector purposes and is not published or
disseminated.\6\ On December 20, 2019, the SEC approved amendments to
Rule 6750 (Dissemination of Transaction Information) to allow FINRA to
publish weekly aggregated transaction information and statistics on
U.S. Treasury Securities at no charge (unless FINRA submits a rule
filing imposing a fee for such data).\7\ Pursuant to amended Rule
6750.01(b), on March 10, 2020 FINRA began posting on its website
weekly, aggregate data on the trading volume of U.S. Treasury
Securities reported to TRACE.\8\
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    \3\ See Regulatory Notice 16-39 (October 2016) (SEC Approves
Rule Change to Require Reporting of Transactions in U.S. Treasury
Securities to the Trade Reporting and Compliance Engine (TRACE));
see also Securities Exchange Act Release No. 79116 (October 18,
2016), 81 FR 73167 (October 24, 2016) (Order Granting Accelerated
Approval of File No. SR-FINRA-2016-027).
    \4\ Under Rule 6710(p), a ``U.S. Treasury Security'' means a
security, other than a savings bond, issued by the U.S. Department
of the Treasury (the ``Treasury Department'') to fund the operations
of the federal government or to retire such outstanding securities.
The term ``U.S. Treasury Security'' also includes separate principal
and interest components of a U.S. Treasury Security that has been
separated pursuant to the Separate Trading of Registered Interest
and Principal of Securities (STRIPS) program operated by the
Treasury Department.
    \5\ FINRA's TRACE rules apply only to FINRA members. However,
FINRA notes that certain banks that are not FINRA members will begin
reporting information on transactions in specified fixed income
securities to TRACE starting on September 1, 2022 pursuant to
requirements adopted by the Board of Governors of the Federal
Reserve System. See Agency Information Collection Activities:
Announcement of Board Approval Under Delegated Authority and
Submission to OMB, 86 FR 59716 (October 28, 2021) (Federal Reserve
approval to implement the Treasury Securities and Agency Debt and
Mortgage-Backed Securities Reporting Requirements (FR 2956; OMB No.
7100-NEW)).
    \6\ Rule 6750(c)(5) provides that FINRA will not disseminate
information on U.S. Treasury Securities.
    \7\ See Securities Exchange Act Release No. 87837 (December 20,
2019), 84 FR 71986 (December 30, 2019) (Order Approving File No. SR-
FINRA-2019-028).
    \8\ See FINRA Press Release, FINRA Launches New Data on Treasury
Securities Trading Volume, available at https://www.finra.org/media-center/newsreleases/2020/finra-launches-new-data-treasury-securities-trading-volume.
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    FINRA has received favorable feedback on the weekly aggregated
trading volume data for U.S. Treasury Securities that is currently made
available on its website and, in consultation with the Treasury
Department, now believes it would be appropriate to increase the
cadence of this aggregated data. Accordingly, FINRA is proposing to
amend paragraph (b) of Supplementary Material .01 to Rule 6750 to
delete the word ``weekly'' so as to permit more frequent publication of
aggregated U.S. Treasury Security transaction information and
statistics, such as on a daily basis.\9\
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    \9\ As it has done previously, FINRA may also continue to modify
and enhance the format and content of the aggregate U.S. Treasury
Security data (e.g., by adding aggregate trade count and pricing
information). For example, in 2021, FINRA enhanced the format of the
weekly aggregate data to include a new maturity category for nominal
coupons: ``Greater than 10 years and less than or equal to 20
years.'' This category was intended to highlight the on-the-run 20-
year bond and provide volume information for off-the-run Treasury
bonds whose remaining maturity fall within the maturity band. See
Technical Notice (April 29, 2021) (Enhancements to Weekly Aggregated
Reports and Statistics for U.S. Treasury Securities).
---------------------------------------------------------------------------

    FINRA notes that the more frequent aggregated U.S. Treasury
Security data would continue to not identify individual market
participants or transactions, and FINRA would continue to not publish
aggregated transaction information and statistics by individual U.S.
Treasury Security (except for the category of on-the-run

U.S. Treasury Securities because there is only one on-the-run security
at a time for each subtype and maturity).\10\ The aggregate U.S.
Treasury Security data would also continue to be provided at no charge
(unless FINRA submits a rule filing to impose a fee for this data).
FINRA believes that the proposed rule change will benefit investors and
market participants by providing timelier insight into U.S. Treasury
market activity, while maintaining the confidentiality of individual
market participants and transactions.
---------------------------------------------------------------------------

    \10\ See Rule 6750.01(b), which currently provides that
aggregated transaction information and statistics on U.S. Treasury
Securities will not be published or distributed by individual
security (except for aggregated data that includes on-the-run U.S.
Treasury Securities that may have had only one on-the-run security
during the aggregated period), and will not identify individual
market participants or transactions.
---------------------------------------------------------------------------

    If the Commission approves the proposed rule change, the effective
date of the proposed rule change will be the date of Commission
approval.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\11\ which requires, among
other things, that FINRA rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest, and Section 15A(b)(9) of the Act,\12\ which requires
that FINRA rules not impose any burden on competition that is not
necessary or appropriate.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78o-3(b)(6).
    \12\ 15 U.S.C. 78o-3(b)(9).
---------------------------------------------------------------------------

    FINRA believes that the proposed rule change will benefit investors
and market participants by providing additional insights into U.S.
Treasury Security transaction volume, while maintaining the
confidentiality of individual market participants and transactions.
Accordingly, FINRA believes the proposed rule change is in the public
interest and will help provide greater transparency in U.S. Treasury
Securities.

B. Self-Regulatory Organization's Statement on Burden on Competition

    FINRA 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.
Economic Impact Assessment
    FINRA has undertaken an economic impact assessment, as set forth
below, to analyze the regulatory need for the proposed rule change, its
potential economic impacts, including anticipated costs and benefits,
and any alternatives considered in assessing how to best meet the
proposal's regulatory objectives.
Regulatory Need
    The purpose of the proposal is described above and is consistent
with TRACE transparency initiatives.
Economic Baseline
    As mentioned above, in July 2017, FINRA member firms began
reporting transactions in U.S. Treasury Securities to TRACE.\13\
Currently, there is no dissemination of transactions to the public,
either real-time or on a delayed basis, as member firms report trade
activity in U.S. Treasury Securities to TRACE for regulatory purposes
only.
---------------------------------------------------------------------------

    \13\ See supra note 3.
---------------------------------------------------------------------------

    There is currently limited publicly available information on U.S.
Treasury Security transaction volume. The Federal Reserve Bank of New
York publishes average daily trading volume and end-of-the-week
positions of primary dealers in U.S. Treasury Securities on a weekly
basis.\14\ As noted above, in March 2020, FINRA began publishing weekly
aggregate volume data in Treasury Securities.\15\
---------------------------------------------------------------------------

    \14\ See https://www.newyorkfed.org/markets/primarydealers for
the definition of ``primary dealers'' and the weekly statistics.
    \15\ See supra note 8.
---------------------------------------------------------------------------

Economic Impacts
    The proposed dissemination of more frequent aggregate volume data
in U.S. Treasury Securities would not impose any additional
requirements on firms. The aggregate volume data published by FINRA
will continue to be derived from trade reports already required to be
submitted to TRACE. In addition, because the data would be available
free of charge, FINRA does not believe that there would be any direct
costs associated with the proposal for firms, investors or data
consumers.
    FINRA expects that the proposed rule change would help market
participants better understand the overall trading of U.S. Treasury
Securities by providing more timely information that could be utilized
in assessing where liquidity is concentrated by security characteristic
and market segment. FINRA believes that publishing more frequent
aggregated data on U.S. Treasury Securities transactions would further
benefit market participants and the investor community by enhancing
overall transparency.
    FINRA also considered information leakage concerns, i.e., whether
market participants' proprietary trading strategy could be discerned
from the published data. FINRA believes that the aggregated framework
mitigates these concerns. As is the case under the current rule,
aggregated transaction information and statistics on U.S. Treasury
Securities will not be published or distributed by individual security
(except for aggregated data that includes on-the-run U.S. Treasury
Securities that may have had only one on-the-run security during the
aggregated period) and will not identify individual market participants
or transactions.
Alternatives Considered
    No other alternatives were considered for the proposed
dissemination framework.

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 self-regulatory organization consents, the Commission will:
    (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 protected]. Please include
File Number SR-FINRA-2022-017 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-FINRA-2022-017. 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 website (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 website 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 a.m. and 3
p.m. Copies of such filing also will be available for inspection and
copying at the principal office of FINRA. All comments received will be
posted without change. Persons submitting comments are cautioned that
we do not redact or edit personal identifying information from comment
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
FINRA-2022-017 and should be submitted on or before July 22, 2022.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2022-14066 Filed 6-30-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: May 19, 2009 (Volume 74, Number 95)]
[Notices]
[Page 23407-23412]
[DOCID:fr19my09-56]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0211]

Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval of
92 New Drug Applications and 49 Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 92 new drug applications (NDAs) and 49 abbreviated new drug
applications (ANDAs) from multiple applicants. The holders of the
applications notified the agency in writing that the drug products were
no longer marketed and requested that the approval of the applications
be withdrawn.

Dates: Effective: June 18, 2009.

FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6366, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: The holders of the applications listed in
the table in this document have informed FDA that these drug products
are no longer marketed and have requested that FDA withdraw approval of
the applications. The applicants have also, by their requests, waived
their opportunity for a hearing.

------------------------------------------------------------------------
 Application No.             Drug                      Applicant
------------------------------------------------------------------------
NDA 6-403         Priscoline (tolazoline      Novartis Pharmaceuticals
                   hydrochloride (HCl)         Corp., One Health Plaza,
                                               East Hanover, NJ 07936-
                                               1080
------------------------------------------------------------------------
NDA 8-303         Apresoline (hydralazine     Do.
                   HCl)
------------------------------------------------------------------------
NDA 9-087         Hydergine (ergoloid         Do.
                   mesylates) Sublingual
                   Tablets
------------------------------------------------------------------------
NDA 9-509         Aramine (metaraminol        Merck & Co., Inc., UG2C-
                   bitartrate) Injection, 10   50, P.O. Box 1000, North
                   milligrams (mg)/            Wales, PA 19454-1099
                   milliliter (mL)
------------------------------------------------------------------------
NDA 9-987         Delta-Cortef                Pharmacia & Upjohn Co., c/
                   (prednisolone) Tablets      o Pfizer, Inc., 235 East
                                               42d St., New York, NY
                                               10017
------------------------------------------------------------------------
NDA 10-060        Florinef (fludrocortisone   King Pharmaceuticals,
                   acetate) Tablets            Inc., 501 5th St.,
                                               Bristol, TN 37620
------------------------------------------------------------------------
NDA 10-392        Atarax (hydroxyzine HCl)    Pfizer, Inc., 235 East 42d
                   Tablets                     St., New York, NY 10017
------------------------------------------------------------------------
NDA 10-485        Atarax (hydroxyzine HCl)    Roerig Pharmaceuticals, c/
                   Syrup                       o Pfizer, Inc.
------------------------------------------------------------------------
NDA 10-571        Compazine                   GlaxoSmithKline, 1250
                   (prochlorperazine           South Collegeville Rd.,
                   maleate) Tablets            UP4110, Collegeville, PA
                                               19426
------------------------------------------------------------------------
NDA 10-611        Halotestin                  Pharmacia & Upjohn Co., c/
                   (fluoxymesterone)           o Pfizer, Inc.
                   Tablets, 2 mg, 5 mg, and
                   10 mg
------------------------------------------------------------------------
NDA 10-686        Moderil (rescinnamine)      Pfizer, Inc.
                   Tablets, 0.25 mg and 0.5
                   mg
------------------------------------------------------------------------
NDA 10-742        Compazine                   GlaxoSmithKline
                   (prochlorperazine
                   edisylate) Injection
------------------------------------------------------------------------
NDA 10-976        Enovid/Enovid-E/Enovid-E    G.D. Searle LLC, c/o
                   21 (norethynodrel and       Pfizer, Inc.
                   mestranol) Tablets
------------------------------------------------------------------------
NDA 11-000        Compazine                   GlaxoSmithKline
                   (prochlorperazine
                   maleate) Extended-Release
                   Capsules
------------------------------------------------------------------------
NDA 11-111        Vistaril (hydroyzine HCl)   Pfizer, Inc.
                   Injection
------------------------------------------------------------------------
NDA 11-127        Compazine                   GlaxoSmithKline
                   (prochlorperazine)
                   Suppositories
------------------------------------------------------------------------
NDA 11-188        Compazine                   Do.
                   (prochlorperazine
                   edisylate) Syrup
------------------------------------------------------------------------
NDA 11-556        Anturane (sulfinpyrazone)   Novartis Pharmaceuticals
                   Tablets and Capsules        Corp.
------------------------------------------------------------------------
NDA 11-635        Diupres (chlorothiazide     Merck & Co., Inc.
                   and reserpine) Tablets
------------------------------------------------------------------------
NDA 11-793        Esidrix                     Novartis Pharmaceuticals
                   (hydrochlorothiazide)       Corp.
                   Tablets
------------------------------------------------------------------------
NDA 11-838        Tofranil (imipramine HCl)   Do.
                   Injection
------------------------------------------------------------------------
NDA 12-193        Ser-Ap-Es (reserpine,       Do.
                   hydralazine HCl, and
                   hydrochlorothiazide)
                   Tablets
------------------------------------------------------------------------
NDA 12-329        Ismelin (guanethidine       Do.
                   monosulfate) Tablets
------------------------------------------------------------------------
NDA 12-753        Torecan (thiethylperazine   Do.
                   maleate) Tablets, 10 mg
------------------------------------------------------------------------
NDA 12-754        Torecan (thiethylperazine   Do.
                   maleate) Injection, 5 mg/
                   mL
------------------------------------------------------------------------
NDA 12-791        Hypertensin (angiotensin    Do.
                   amide) Injection
------------------------------------------------------------------------
NDA 12-845        Renese (polythiazide)       Pfizer, Inc.
                   Tablets, 1 mg, 2 mg, and
                   4 mg
------------------------------------------------------------------------
NDA 13-636        Renese-R (polythiazide and  Do.
                   reserpine) Tablets, 2 mg/
                   0.25 mg
------------------------------------------------------------------------
NDA 15-500        Tolinase (tolazamide)       Pharmacia & Upjohn Co., c/
                   Tablets                     o Pfizer, Inc.
------------------------------------------------------------------------
NDA 16-029        Ovulen (ethynodiol          G.D. Searle LLC, c/o
                   diacetate and mestranol)    Pfizer, Inc.
                   Tablets
------------------------------------------------------------------------
NDA 16-126        Primatene (epinephrine      Wyeth Consumer Healthcare,
                   bitartrate) Mist, 0.2 mg,   Five Giralda Farms,
                   and Bronitin (epinephrine   Madison, NJ 07940
                   bitartrate) Mist, 0.3 mg
------------------------------------------------------------------------
NDA 16-635        Cyanocobalamin CO-57        Mallinckrodt Medical, c/o
                   Schilling Test Kit          Mallinckrodt, Inc., 675
                                               McDonnell Blvd.,
                                               Hazelwood, MO 63042
------------------------------------------------------------------------

NDA 16-705        Ovulen-28 (ethynodiol       G.D. Searle LLC, c/o
                   diacetate and mestranol)    Pfizer, Inc.
                   Tablets
------------------------------------------------------------------------
NDA 16-709        Ortho-Novum 1/50-28         Ortho-McNeil-Janssen
                   (norethindrone and          Pharmaceutical, Inc., c/o
                   mestranol) Tablets          Johnson & Johnson
                                               Pharmaceutical Research &
                                               Development, LLC, 920 Rt.
                                               202, P.O. Box 300,
                                               Raritan, NJ 08869
------------------------------------------------------------------------
NDA 16-758        Navane (thiothixene HCl)    Pfizer, Inc.
                   Oral Concentrate
------------------------------------------------------------------------
NDA 16-834        Lithane (lithium            Do.
                   carbonate) Tablets
------------------------------------------------------------------------
NDA 16-904        Navane (thiothixene HCl)    Do.
                   Injection
------------------------------------------------------------------------
NDA 17-059        TechneColl (technetium Tc-  Mallinckrodt Medical, c/o
                   99m sulfur colloid kit)     Mallinckrodt, Inc.
------------------------------------------------------------------------
NDA 17-247        Sanorex (mazindol) Tablets  Novartis Pharmaceuticals
                                               Corp.
------------------------------------------------------------------------
NDA 17-476        Slow-K (potassium           Do.
                   chloride) Extended-
                   Release Tablets
------------------------------------------------------------------------
NDA 17-543        Ludiomil (maprotiline HCl)  Novartis Pharmaceuticals
                   Tablets, 25 mg, 50 mg,      Corp.
                   and 75 mg
------------------------------------------------------------------------
NDA 17-551        Perchloracap (potassium     Mallinckrodt Medical, c/o
                   perchlorate) Capsules       Mallinckrodt, Inc.
------------------------------------------------------------------------
NDA 17-842        TechneScan MAA (technetium  Do.
                   Tc-99m albumin aggregate
                   kit)
------------------------------------------------------------------------
NDA 17-844        Radioiodinated Serum        Do.
                   Albumin (Human) IHSA I-
                   125 (iodinated I-125
                   albumin injection)
------------------------------------------------------------------------
NDA 17-851        Lioresal (baclofen)         Novartis Pharmaceuticals
                   Tablets, 10 mg and 20 mg    Corp.
------------------------------------------------------------------------
NDA 17-971        Eskalith (lithium           JDS Pharmaceuticals, LLC,
                   carbonate) Tablets, 300     c/o Noven
                   mg                          Pharmaceuticals, Inc.,
                                               11960 SW. 44th St.,
                                               Miami, FL 33186
------------------------------------------------------------------------
NDA 17-986        Minizide (prazosin HCl and  Pfizer, Inc.
                   polythiazide) Capsules, 1
                   mg, 2 mg, and 5 mg
------------------------------------------------------------------------
NDA 18-006        Meclomen (meclofenamate     Parke-Davis, a subsidiary
                   sodium) Capsules, 50 mg     of Pfizer, Inc.
                   and 100 mg
------------------------------------------------------------------------
NDA 18-152        Eskalith CR (lithium        JDS Pharmaceuticals, LLC,
                   carbonate) Controlled-      c/o Noven
                   Release Tablets, 450 mg     Pharmaceuticals, Inc.
------------------------------------------------------------------------
NDA 18-202        Cytadren                    Novartis Pharmaceuticals
                   (aminoglutethimide)         Corp.
                   Tablets
------------------------------------------------------------------------
NDA 18-245        Syntocinon (oxytocin)       Do.
                   Injection
------------------------------------------------------------------------
NDA 18-249        Sodium Lactate Injection    Hospira, Inc., 275 North
                   USP                         Field Dr., Lake Forest,
                                               IL 60045-5046
------------------------------------------------------------------------
NDA 18-272        Technescan Gluceptate       Draximage, a division of
                   (technetium Tc-99m          DRAXIS Specialty
                   gluceptate kit)             Pharmaceuticals, Inc.,
                                               16751 Autoroute
                                               TransCanada Highway,
                                               Kirkland, Qu. Canada H9H
                                               4J4
------------------------------------------------------------------------
NDA 18-285        Visken (prindolol) Tablets  Novartis Pharmaceuticals
                                               Corp.
------------------------------------------------------------------------
NDA 18-535        Diulo (metolazone)          G.D. Searle LLC, c/o
                   Tablets, 2.5 mg, 5 mg,      Pfizer, Inc.
                   and 10 mg
------------------------------------------------------------------------
NDA 18-536        Xenon Xe-127 Gas            Mallinckrodt, Inc.
------------------------------------------------------------------------
NDA 18-904        Urologic G (citric acid,    Hospira, Inc.
                   sodium carbonate, and
                   magnesium oxide)
                   Irrigation in Plastic
                   Containers
------------------------------------------------------------------------
NDA 19-650        Flumadine (rimantadine      Forest Laboratories, Inc.,
                   HCl) Syrup                  Harborside Financial
                                               Center III, suite 602,
                                               Jersey City, NJ 07311
------------------------------------------------------------------------
NDA 19-672        Efidac 24 Pseudoephedrine/  Alza Corp., 1900
                   Brompheniramine             Charleston Rd., P.O. Box
                   (pseudoephedrine HCl and    7210, Mountain View, CA
                   brompheniramine maleate)    94039-7210
                   Extended-Release Tablets
------------------------------------------------------------------------
NDA 19-721        Norditropin (somatropin     Novo Nordisk Inc., 100
                   recombinant) for            College Rd. West,
                   Injection                   Princeton, NJ 08540
------------------------------------------------------------------------
NDA 19-746        Efidac 24 Chlorpheniramine  Alza Corp.
                   (chlorpheniramine
                   maleate) Extended-Release
                   Tablets
------------------------------------------------------------------------

NDA 19-753        Ethmozine (moricizine HCl)  Shire Development, Inc.,
                   Tablets                     725 Chesterbrook Blvd.,
                                               Wayne, PA 19087
------------------------------------------------------------------------
NDA 19-762        Testoderm (testosterone)    Alza Corp.
                   and Testoderm with
                   Adhesive
------------------------------------------------------------------------
NDA 19-775        Minipress XL (prazosin      Pfizer, Inc.
                   HCl) Extended-Release
                   Tablets
------------------------------------------------------------------------
NDA 19-794        Depakote CP (divalproex     Abbott Laboratories, 200
                   sodium) Delayed-Release     Abbott Park Rd., Abbott
                   Tablets                     Park, IL 60664-6157
------------------------------------------------------------------------
NDA 19-863        Geref Diagnostic            EMD Serono, Inc., One
                   (sermorelin acetate) for    Technology Dr., Rockland,
                   Injection                   MA 02370
------------------------------------------------------------------------
NDA 19-983        Prostep (nicotine)          Aveva Drug Delivery
                   Transdermal System, 11 mg/  Systems, Inc., 3250
                   24 hour (h) and 22 mg/24    Commerce Pkwy., Miramar,
                   h                           FL 33025
------------------------------------------------------------------------
NDA 20-013        Maxaquin (lomefloxacin      Pharmacia & Upjohn Co., c/
                   HCl) Tablets                o Pfizer, Inc.
------------------------------------------------------------------------
NDA 20-044        Exosurf Neonatal            GlaxoSmithKline, P.O. Box
                   (colfosceril palmitate,     13398, Five Moore Dr.,
                   cetyl alcohol, and          Research Triangle Park,
                   tyloxapol) Powder for       NC 27709-3398
                   Suspension
------------------------------------------------------------------------
NDA 20-087        Floxin (ofloxacin)          Ortho-McNeil
                   Solution for Injection      Pharmaceutical, Inc., c/o
                                               Johnson & Johnson
                                               Pharmaceutical Research &
                                               Development, LLC
------------------------------------------------------------------------
NDA 20-137        Demadex (torsemide)         Hoffman-La Roche, Inc.,
                   Injection                   340 Kingsland St.,
                                               Nutley, NJ 07110-1199
------------------------------------------------------------------------
NDA 20-144        Transderm-Nitro             Novartis Pharmaceuticals
                   (nitroglycerin)             Corp.
------------------------------------------------------------------------
NDA 20-154        Videx (didanosine)          Bristol-Meyers Squibb, 5
                   Chewable Tablets            Research Pkwy., Signature
                                               91 Bldg., Wallingford, CA
                                               06492
------------------------------------------------------------------------
NDA 20-155        Videx (didanosine)          Do.
                   Buffered Powder for Oral
                   Solution
------------------------------------------------------------------------
NDA 20-199        Hivid (zalcitabine)         Hoffman-La Roche, Inc.
                   Tablets
------------------------------------------------------------------------
NDA 20-250        Halfan (halofantrine HCl)   GlaxoSmithKline, One
                   Tablets                     Franklin Plaza, P.O. Box
                                               7929, Philadelphia, PA
                                               19101-7929
------------------------------------------------------------------------
NDA 20-306        Fludeoxyglucose F-18        Downstate Clinical PET
                   Injection                   Center--Methodist Medical
                                               Center of Illinois, 221
                                               NE. Glen Oak Ave.,
                                               Peoria, IL 61636-0002
------------------------------------------------------------------------
NDA 20-443        Geref (sermorelin acetate)  EMD Serono, Inc.
                   for Injection
------------------------------------------------------------------------
NDA 20-545        Procanbid (procainamide     King Pharmaceuticals, Inc.
                   HCl) Extended-Release
                   Tablets, 500 mg and 1,000
                   mg
------------------------------------------------------------------------
NDA 20-686        LumenHance (manganese       Bracco Diagnostics Inc.,
                   chloride tetrahydrate)      107 College Rd. East,
                   for Solution                Princeton, NJ 08540
------------------------------------------------------------------------
NDA 20-773        SonoRX (simethicone coated  Do.
                   cellulose) Suspension
------------------------------------------------------------------------
NDA 20-791        Testoderm TTS               Alza Corp.
                   (testosterone transdermal
                   system), 5 mg/24 h
------------------------------------------------------------------------
NDA 21-019        Compazine                   GlaxoSmithKline,
                   (prochlorperazine           Collegeville, PA 19426
                   maleate) Extended-Release
                   Capsules
------------------------------------------------------------------------
NDA 21-868        Exubera (insulin            Pfizer, Inc.
                   recombinant human)
                   Inhalation Powder, 1 mg
                   and 3 mg
------------------------------------------------------------------------
ANDA 40-092       Digoxin Injection USP, 0.1  Hospira, Inc.
                   mg/mL
------------------------------------------------------------------------
NDA 50-109        Mithracin (plicamycin)      Pfizer, Inc.
                   Injection, 2.5 mg
------------------------------------------------------------------------
NDA 50-286        Terramycin                  Do.
                   (oxytetracycline HCl)
                   Capsules
------------------------------------------------------------------------
NDA 50-316        Lincocin (lincomycin HCl)   Pharmacia & Upjohn Co., c/
                   Capsules, 250 mg and 500    o Pfizer, Inc.
                   mg
------------------------------------------------------------------------
NDA 50-461        Ancef (cefazolin) for       SmithKline Beecham, d/b/a
                   Injection                   GlaxoSmithKline,
                                               Philadelphia, PA 19101-
                                               7929
------------------------------------------------------------------------
NDA 50-529        Pediazole (erythromycin     Ross Products Division,
                   ethylsuccinate and          Abbott Laboratories, 3300
                   sulfisoxazole acetyl) for   Stelzer Rd., Columbus, OH
                   Oral Suspension             43219-3034
------------------------------------------------------------------------

NDA 50-613        Cefobid (cefoperazone       Pfizer, Inc.
                   sodium) Injection
------------------------------------------------------------------------
NDA 50-667        Lorabid (loracarbef for     King Pharmaceuticals, Inc.
                   oral suspension USP), 100
                   mg/5 mL and 200 mg/5 mL
------------------------------------------------------------------------
NDA 50-763        Mitozytrex (mitomycin) for  SuperGen, Inc., 4140
                   Injection, 5 mg/vial        Dublin Blvd., suite 200,
                                               Dublin, CA 94568
------------------------------------------------------------------------
ANDA 61-014       Terramycin                  Pfizer, Inc.
                   (oxytetracycline HCl)
                   Ophthalmic Solution
------------------------------------------------------------------------
ANDA 61-229       Polysporin Ophthalmic       Monarch Pharmaceuticals,
                   Ointment (bacitracin zinc   Inc. (a wholly-owned
                   and polymyxin B sulfate     subsidiary of King
                   ophthalmic ointment)        Pharmaceuticals, Inc.),
                                               501 5th St., Bristol, TN
                                               37620
------------------------------------------------------------------------
ANDA 64-099       Amikacin Sulfate Injection  Hospira, Inc.
                   USP, 250 mg/mL
------------------------------------------------------------------------
ANDA 70-252       Naloxone HCl Injection      Do.
                   USP, 0.02 mg/mL
------------------------------------------------------------------------
ANDA 70-253       Naloxone HCl Injection      Do.
                   USP, 0.02 mg/mL
------------------------------------------------------------------------
ANDA 71-166       Bupivacaine HCl and         Do.
                   Epinephrine Injection USP
------------------------------------------------------------------------
ANDA 71-169       Bupivacaine HCl and         Do.
                   Epinephrine Injection USP
------------------------------------------------------------------------
ANDA 71-171       Bupivacaine HCl and         Do.
                   Epinephrine Injection USP
------------------------------------------------------------------------
ANDA 73-685       Acilac (lactulose solution  Nostrum Laboratories,
                   USP), 10 grams (g)/15 mL    Inc., 1800 North Topping
                                               Ave., Kansas City, MO
                                               64120
------------------------------------------------------------------------
ANDA 73-686       Laxilose (lactulose         Do.
                   solution USP), 10 g/15 mL
------------------------------------------------------------------------
ANDA 74-083       Nitroglycerin in 5%         Hospira, Inc.
                   Dextrose Injection, 0.1
                   mg/mL
------------------------------------------------------------------------
ANDA 74-127       Atenolol Tablets USP, 50    Nostrum Laboratories, Inc.
                   mg and 100 mg
------------------------------------------------------------------------
ANDA 74-337       Furosemide Injection USP,   Hospira, Inc.
                   10 mg/mL
------------------------------------------------------------------------
ANDA 74-391       Diclofenac Sodium Delayed-  Roxane Laboratories, Inc.,
                   Release Tablets USP, 25     1809 Wilson Rd., P.O. Box
                   mg, 50 mg, and 75 mg        16532, Columbus, OH 43216-
                                               6532
------------------------------------------------------------------------
ANDA 74-403       Dopamine HCl Injection      Hospira, Inc.
                   USP, 40 mg/mL
------------------------------------------------------------------------
ANDA 74-404       Atenolol and                Nostrum Laboratories, Inc.
                   Chlorthalidone Tablets
                   USP, 50 mg/25 mg and 100
                   mg/25 mg
------------------------------------------------------------------------
ANDA 74-474       Pindolol Tablets USP, 5 mg  Do.
                   and 10 mg
------------------------------------------------------------------------
ANDA 74-740       Atracurium Besylate         Hospira, Inc.
                   Injection USP, 10 mg/mL
------------------------------------------------------------------------
ANDA 74-741       Atracurium Besylate         Do.
                   Injection USP, 10 mg/mL
------------------------------------------------------------------------
ANDA 75-088       Cromoptic (cromolyn         King Pharmaceuticals, Inc.
                   sodium) Ophthalmic
                   Solution, 4%
------------------------------------------------------------------------
ANDA 75-162       Clozapine Tablets USP, 25   Par Pharmaceutical, Inc.,
                   mg and 100 mg               One Ram Ridge Rd., Spring
                                               Valley, NY 10977
------------------------------------------------------------------------
ANDA 75-466       Doxazosin Mesylate          Genpharm Inc., c/o Mylan
                   Tablets, 1 mg, 2 mg, 4      Pharmaceuticals, Inc.,
                   mg, and 8 mg                781 Chestnut Ridge Rd.,
                                               P.O. Box 4310,
                                               Morgantown, WV 26504-4310
------------------------------------------------------------------------
ANDA 75-558       Vecuronium Bromide for      Hospira, Inc.
                   Injection, 4 mg/Ampul
------------------------------------------------------------------------
ANDA 75-762       Ofloxacin Injection, 40 mg/ Bedford Laboratories,
                   mL                          Division of Ben Venue
                                               Laboratories, Inc., 300
                                               Northfield Rd., Bedford,
                                               OH 44146
------------------------------------------------------------------------
ANDA 75-899       Fluvoxamine Maleate         Synthon Pharmaceuticals,
                   Tablets, 25 mg, 50 mg,      Inc., 9000 Development
                   and 100 mg                  Dr., P.O. Box 110487,
                                               Research Triangle Park,
                                               NC 27709
------------------------------------------------------------------------
ANDA 76-138       Ciprofloxacin HCl Tablets   Nostrum Laboratories, Inc.
                   USP, 250 mg, 500 mg, and
                   750 mg
------------------------------------------------------------------------
ANDA 76-213       Fluconazole Tablets, 50     Roxane Laboratories, Inc.
                   mg, 100 mg, 150 mg, and
                   200 mg
------------------------------------------------------------------------
ANDA 76-270       Mirtazapine Tablets USP,    Do.
                   15 mg, 30 mg, and 45 mg
------------------------------------------------------------------------

ANDA 76-476       Benazepril HCl Tablets, 5   Mylan Pharmaceuticals,
                   mg, 10 mg, 20 mg, and 40    Inc.
                   mg
------------------------------------------------------------------------
ANDA 76-489       Anagrelide HCl Capsules,    Roxane Laboratories, Inc.
                   0.5 mg and 1 mg
------------------------------------------------------------------------
ANDA 77-249       Oxandrolone Tablets USP,    Do.
                   2.5 mg and 10 mg
------------------------------------------------------------------------
ANDA 77-445       Polyethylene Glycol 3350    Teva Pharmaceuticals USA,
                   Powder for Oral Solution    1090 Horsham Rd., P.O.
                                               Box 1090, North Wales, PA
                                               19454
------------------------------------------------------------------------
ANDA 77-648       Zonisamide Capsules, 25     Roxane Laboratories, Inc.
                   mg, 50 mg, and 100 mg
------------------------------------------------------------------------
ANDA 78-026       Paroxetine Tablets USP, 10  Do.
                   mg, 20 mg, 30 mg, and 40
                   mg
------------------------------------------------------------------------
ANDA 81-008       Strifon Forte DSC           Ferndale Laboratories, 780
                   (chlorzoxazone tablets      West 8th Mile Rd.,
                   USP), 500 mg                Ferndale, MI 48220
------------------------------------------------------------------------
ANDA 81-095       Acetaminophen, Aspirin,     Mikart, Inc., 1750
                   and Codeine Phosphate       Chattahoochee Ave.,
                   Capsules, 150 mg/180 mg/    Atlanta, GA 30318
                   15 mg
------------------------------------------------------------------------
ANDA 83-283       Isoproterenol HCl           Hospira, Inc.
                   Injection USP, 0.02 mg/mL
------------------------------------------------------------------------
ANDA 83-838       Promethazine HCl Injection  Do.
                   USP
------------------------------------------------------------------------
ANDA 84-074       Bethanechol Chloride        Lannett Co., Inc., 9000
                   Tablets USP, 25 mg          State Rd., Philadelphia,
                                               PA 19136
------------------------------------------------------------------------
ANDA 84-702       Bethanechol Chloride        Do.
                   Tablets USP, 5 mg
------------------------------------------------------------------------
ANDA 84-712       Bethanechol Chloride        Do.
                   Tablets USP, 10 mg
------------------------------------------------------------------------
ANDA 84-735       Apresazide (hydralazine     Novartis Pharmaceuticals
                   HCl and                     Corp.
                   hydrochlorothiazide)
                   Capsules, 25 mg/25 mg
------------------------------------------------------------------------
ANDA 84-810       Apresazide (hydralazine     Do.
                   HCl and
                   hydrochlorothiazide)
                   Capsules, 50 mg/50 mg
------------------------------------------------------------------------
ANDA 86-366       Acetaminophen and Codeine   Roxane Laboratories, Inc.
                   Phosphate Oral Solution
                   USP, 120 mg/12 mg per 5
                   mL
------------------------------------------------------------------------
ANDA 87-563       Quibron-T/SR                Monarch Pharmaceuticals,
                   (theophylline) Extended-    Inc.
                   Release Tablets, 300 mg
------------------------------------------------------------------------
ANDA 88-126       Aminophylline Oral          Roxane Laboratories, Inc.
                   Solution USP, 105 mg/5 mL
------------------------------------------------------------------------
ANDA 88-656       Quibron-T (theophylline)    Monarch Pharmaceuticals,
                   Tablets, 300 mg             Inc.
------------------------------------------------------------------------
ANDA 89-650       Lidocaine HCl and           Hospira, Inc.
                   Epinephrine Injection USP
------------------------------------------------------------------------

    Therefore, under section 505(e) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(e)) and under authority delegated to the
Director, Center for Drug Evaluation and Research, by the Commissioner
of Food and Drugs, approval of the applications listed in the table in
this document, and all amendments and supplements thereto, is hereby
withdrawn, effective June 18, 2009.

    Dated: April 30, 2009.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. E9-11628 Filed 5-18-09; 8:45 am]

BILLING CODE 4160-01-S