[Federal Register: April 17, 2009 (Volume 74, Number 73)]
[Proposed Rules]
[Page 17799-17802]
[DOCID:fr17ap09-13]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-27687; Directorate Identifier 2000-NE-42-AD]
RIN 2120-AA64

Airworthiness Directives; General Electric Company CF34-1A, -3A,
-3A1, -3A2, -3B, and -3B1 Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Supplemental Notice of proposed rulemaking (NPRM); reopening of
comment period.

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SUMMARY: This notice revises an earlier proposed airworthiness
directive (AD), and supersedes an existing AD applicable to General
Electric Company (GE) CF34-1A, -3A, -3A1, -3A2, -3B, and -3B1 turbofan
engines. This proposed AD reopens the comment period, since we added
additional requirements based on responses we received. This proposed
AD would now require:
     Inspecting certain fan disks for electrical arc-out
indications,
     Removing from service fan disks with electrical arc-out
indications,
     Performing tactile and enhanced visual (TEV) inspections,
fluorescent penetrant inspections (FPI), and eddy current inspections
(ECI) on certain disks that have already had a shop-level inspection,
and
     Repetitive FPI and ECI on certain fan disks.
    This proposed AD results from an updated risk analysis by GE that
shows we need to take corrective action that is more stringent. We are
proposing this AD to prevent an uncontained failure of the fan disk,
which could result in damage to the airplane.

DATES: We must receive any comments on this proposed AD by June 16,
2009.

ADDRESSES: Use one of the following addresses to comment on this
proposed AD.
     Federal eRulemaking Portal: Go to http://
www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Contact General Electric Company via Lockheed Martin Technology
Services, 10525 Chester Road, Suite C, Cincinnati, Ohio 45215;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>, for the service
information identified in this proposed AD.

FOR FURTHER INFORMATION CONTACT: Tara Chaidez, Aerospace Engineer,
Engine Certification Office, FAA, Engine and Propeller Directorate, 12
New England Executive Park, Burlington, MA 01803; e-mail:
<EMAIL_ADDRESS>telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send us any written relevant data, views, or
arguments regarding this proposal. Send your comments to an address
listed under ADDRESSES. Include ``Docket No. FAA-2007-27687;
Directorate Identifier 2000-NE-42-AD'' in the subject line of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of the proposed AD. We will
consider all comments received by the closing date and may amend the
proposed AD in light of those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact
with FAA personnel concerning this proposed AD. Using the search
function of the Web site, anyone can find and read the comments in any
of our dockets, including, if provided, the name of the individual who
sent the comment (or signed the comment on behalf of an association,
business, labor union, etc.). You may review the DOT's complete Privacy
Act Statement in the Federal Register published on April 11, 2000 (65
FR 19477-78).

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
the same as the Mail address provided in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

Discussion

    We proposed to amend 14 CFR part 39 by superseding AD 2007-07-07R1,
Amendment 39-15179 (72 FR 49183, August 28, 2007). That AD requires a
onetime inspection of certain fan disks for electrical arc-out
indications, replacing fan disks with electrical arc-out indications,
and reducing the life limit of certain fan disks. That NPRM was
prompted by us determining that we inadvertently left out an inspection
requirement in Table C of AD 2007-07-07R1 to perform a shop inspection
on disks that have greater than 6,000 flight hours and have already
undergone a shop inspection. That condition, if not corrected, could
result in an uncontained fan disk failure and airplane damage. On
January 18, 2008, we published that proposal as an NPRM in the Federal
Register (73 FR 3425). That NPRM would have required:
     Replacing certain fan disks installed on regional jets
within 15 days after the effective date of the proposed AD, and
     On-wing and shop-level inspections of fan disks for
electrical arc-out defects on fan disks installed on regional jets, and
     Shop-level inspections of fan disks for electrical arc-out
defects on fan disks installed on business jets.
    Since we issued that NPRM, GE performed an updated risk analysis
that shows we need to take corrective action that is more stringent
than that proposed in the NPRM. We also propose to amend 14 CFR part 39
by superseding AD 2007-05-16, Amendment 39-14977 (72 FR 10054, March 7,
2007). That AD requires a onetime visual and tactile inspection of
certain areas of certain P/N and SN fan disks for an arc-out defect,
within 20 engine flight hours after the effective date of that AD.
Since we issued that AD, GE has added those SN fan disks to the
applicable service bulletins for the repetitive inspection requirements
of this proposed AD.
    Since these changes expand the scope of the originally proposed
rule, we have determined that it is necessary to reopen the comment
period to provide additional opportunity for public comment. This
condition, if not corrected, could result in an uncontained failure of
the fan disk and damage to the airplane.

Relevant Service Information

    We have reviewed and approved the technical contents of GE Alert
Service Bulletins (ASBs) No. CF34-BJ S/B 72-A0212, Revision 04, dated
October 27, 2008; CF34-BJ S/B 72-A0234, dated October 27, 2008; CF34-BJ
S/B 72-A0235, dated October 27, 2008; CF34-AL S/B 72-A0233, Revision
04, dated October 27, 2008; CF34-AL S/B 72-A0252, dated October 27,
2008; and CF34-AL S/B 72-A0253, dated October 27, 2008. These ASBs list
the affected fan disks by serial number, part number, and tier, and
describe procedures for performing TEV inspections, FPI, and ECI for
cracks and electrical arc-out defects.

FAA's Determination and Requirements of the Proposed AD

    We have evaluated all pertinent information and identified an
unsafe condition that is likely to exist or develop on other products
of this same type design. We are proposing this AD, which would require
initial and repetitive FPI, ECI, and TEV inspections. The proposed AD
would require you to use the service information described previously
to perform these actions.

Costs of Compliance

    We estimate that this proposed AD would affect 1,531 engines
installed on airplanes of U.S. registry. We also estimate that it would
take about 2 work-hours per engine to perform the proposed on-wing
inspection on 300 engines, and 4 work-hours per engine to perform the
proposed shop inspection on 1,531 engines. The average labor rate is
$80 per work-hour. There are no required parts. Based on these figures,
we estimate the total cost of the proposed AD to U.S. operators to be
$537,920.

Authority for This Rulemaking

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

Regulatory Findings

    We have determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that the proposed AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD. You may get a copy of this summary at the
address listed under ADDRESSES.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

    Under the authority delegated to me by the Administrator, the
Federal Aviation Administration proposes to amend 14 CFR part 39 as
follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by removing Amendment 39-14977 (72 FR
10054, March 7, 2007) and Amendment 39-15179 (72 FR 49183, August 28,
2007), and by adding a new airworthiness directive to read as follows:

General Electric Company: Docket No. FAA-2007-27687; Directorate
Identifier 2000-NE-42-AD.

Comments Due Date

    (a) The Federal Aviation Administration (FAA) must receive
comments on this airworthiness directive (AD) action by June 16,
2009.
    (b) This AD supersedes AD 2007-05-16, Amendment 39-14977 and AD
2007-07-07R1, Amendment 39-15179.

Applicability

    (c) This AD applies to General Electric Company (GE) CF34-1A, -
3A, -3A1, -3A2, -3B, and -3B1 turbofan engines, with fan disks part
numbers (P/Ns) 5921T18G01, 5921T18G09, 5921T18G10, 5921T54G01,
5922T01G02, 5922T01G04, 5922T01G05, 6020T62G04, 6020T62G05,
6078T00G01, 6078T57G01, 6078T57G02, 6078T57G03, 6078T57G04,
6078T57G05, and 6078T57G06 installed. These engines are installed
on, but not limited to, Bombardier Canadair airplane models CL-600-
2A12, -2B16, and -2B19.

Unsafe Condition

    (d) This AD results from an updated risk analysis by GE that
shows we need to take corrective action that is more stringent. We
are issuing this AD to prevent an uncontained failure of the fan
disk, which could result in damage to the airplane.

Compliance

    (e) You are responsible for having the actions required by this
AD performed within the compliance times specified unless the
actions have already been done.

Removing Certain Fan Disks from Service

    (f) For fan disks listed by P/N and serial number (SN) in Table
2 of GE Alert Service Bulletin (ASB) CF34-BJ S/B 72-A0212, Revision
04, dated October 27, 2008; or in Table 2 of GE ASB CF34-AL S/B 72-
A0233, Revision 04, dated October 27, 2008 that have 8,000 CSN or
more on the effective date of this AD, remove fan disks from service
within 15 days after the effective date of this AD.
    (g) For fan disks listed by P/N and serial number (SN) in Table
2 of GE Alert Service Bulletin (ASB) CF34-BJ S/B 72-A0212, Revision
04, dated October 27, 2008; or in Table 2 of GE ASB CF34-AL S/B 72-
A0233, Revision 04, dated October 27, 2008, that have fewer than
8,000 CSN on the effective date of this AD, remove fan disks from
service before accumulating 8,000 CSN.

Inspections of Tier 1 Fan Disks

    (h) For CF34-3A1 engines with fan drive shaft, P/N 6036T78P02,
and airworthiness limitation section life limit of 22,000 CSN, and
CF34-3B1 turbofan engines with Tier 1 fan disks listed by P/N, SN,
and Tier in Table 1 of GE ASB No. CF34-AL S/B 72-A0233, Revision 04,
dated October 27, 2008, do the following:

Tactile and Enhanced Visual (TEV) Inspections, Fluorescent Penetrant
Inspections (FPI), and Eddy Current Inspections (ECI)

    (1) For Tier 1 fan disks not already inspected using GE ASB No.
CF34-AL S/B 72-A0233, Revision 03, dated June 27, 2007, or earlier
issue, do the following:
    (i) Perform a TEV inspection, an FPI, and an ECI on the Tier 1
fan disks within 650 cycles-in-service (CIS) after the effective
date of this AD. Use paragraph 3.A of the Accomplishment
Instructions of GE ASB CF34-AL S/B 72-A0233, Revision 04, dated

October 27, 2008, to perform the TEV inspection, FPI, and ECI.
    (ii) Thereafter, perform repetitive ECI on the Tier 1 fan disks
within intervals of 3,000 cycles-since-last inspection (CSLI). Use
paragraph 3.A of the Accomplishment Instructions of GE ASB CF34-AL
S/B 72-A0252, dated October 27, 2008, to perform the repetitive ECI.
    (2) For Tier 1 fan disks, listed by P/N, SN, and Tier in Table 1
of GE ASB No. CF34-AL S/B 72-A0233, Revision 04, dated October 27,
2008; already inspected using GE ASB No. CF34-AL S/B 72-A0233,
Revision 03, dated June 27, 2007, or earlier issue, do the
following:
    (i) For Tier 1 fan disks with 2,500 or more CSLI on the
effective date of this AD, perform an ECI on the Tier 1 fan disks
within 500 CIS after the effective date of this AD. Use paragraph
3.A of the Accomplishment Instructions of GE ASB CF34-AL S/B 72-
A0252, dated October 27, 2008, to perform the ECI.
    (ii) For Tier 1 fan disks with fewer than 2,500 CSLI on the
effective date of this AD, perform an ECI on the Tier 1 fan disks
within 3,000 CSLI. Use paragraph 3.A of the Accomplishment
Instructions of GE ASB CF34-AL S/B 72-A0252, dated October 27, 2008,
to perform the ECI.
    (iii) Thereafter, perform repetitive ECI on the Tier 1 fan disks
within intervals of 3,000 CSLI. Use paragraph 3.A of the
Accomplishment Instructions of GE ASB CF34-AL S/B 72-A0252, dated
October 27, 2008, to perform the repetitive ECI.

Inspections of Tier 2 Fan Disks

    (i) For CF34-3A1 engines with fan drive shaft, P/N 6036T78P02,
and airworthiness limitation section life limit of 22,000 CSN, and
CF34-3B1 turbofan engines with Tier 2 fan disks listed by P/N, SN,
and Tier in Table 1 of GE ASB No. CF34-AL S/B 72-A0233, Revision 04,
dated October 27, 2008, do the following:

TEV Inspections, FPI, and ECI

    (1) For Tier 2 fan disks not already inspected using GE ASB No.
CF34-AL S/B 72-A0233, Revision 03, dated June 27, 2007, or earlier
issue, do the following:
    (i) Perform a TEV inspection, an FPI, and an ECI on the Tier 2
fan disks within 2,000 CIS after the effective date of this AD, or
within 5,000 CIS after September 12, 2007, or by March 19, 2012,
whichever occurs first. Use paragraph 3.A of the Accomplishment
Instructions of GE ASB CF34-AL S/B 72-A0233, Revision 04, dated
October 27, 2008, to perform the TEV inspection, FPI, and ECI.
    (ii) Thereafter, perform repetitive eddy current inspections on
the Tier 2 fan disks within intervals of 3,000 CSLI. Use paragraph
3.A of the Accomplishment Instructions of GE ASB CF34-AL S/B 72-
A0252, dated October 27, 2008, to perform the repetitive ECI.
    (2) For Tier 2 fan disks, listed by P/N, SN, and Tier in Table 1
of GE ASB No. CF34-AL S/B 72-A0233, Revision 04, dated October 27,
2008; already inspected using GE ASB No. CF34-AL S/B 72-A0233,
Revision 03, dated June 27, 2007, or earlier issue, do the
following:
    (i) For Tier 2 fan disks with 2,500 or more CSLI on the
effective date of this AD, perform an ECI on the Tier 2 fan disks
within 500 CIS after the effective date of this AD. Use paragraph
3.A of the Accomplishment Instructions of GE ASB CF34-AL S/B 72-
A0252, dated October 27, 2008, to perform the ECI.
    (ii) For Tier 2 fan disks with fewer than 2,500 CSLI on the
effective date of this AD, perform an ECI on the Tier 2 fan disks
within 3,000 CSLI. Use paragraph 3.A of the Accomplishment
Instructions of GE ASB CF34-AL S/B 72-A0252, dated October 27, 2008,
to perform the ECI.
    (iii) Thereafter, perform repetitive ECI on the Tier 2 fan disks
within intervals of 3,000 CSLI. Use paragraph 3.A of the
Accomplishment Instructions of GE ASB CF34-AL S/B 72-A0252, dated
October 27, 2008, to perform the repetitive ECI.

Inspections of Tier 3 Fan Disks

    (j) For CF34-3A1 engines with fan drive shaft, P/N 6036T78P02,
and airworthiness limitation section life limit of 22,000 CSN, and
CF34-3B1 turbofan engines with Tier 3 fan disks, listed by P/N, SN,
and Tier in Table 1 of GE ASB No. CF34-AL S/B 72-A0233, Revision 04,
dated October 27, 2008, do the following:

TEV Inspections, FPI, and ECI

    (1) For Tier 3 fan disks not already inspected using GE ASB No.
CF34-AL S/B 72-A0233, Revision 03, dated June 27, 2007, or earlier
issue, perform a TEV inspection, an FPI, and an ECI on the Tier 3
fan disks within 5,000 CIS after September 12, 2007, or by March 19,
2012, whichever is earlier. Use paragraph 3.A of the Accomplishment
Instructions of GE ASB CF34-AL S/B 72-A0253, Revision 04, dated
October 27, 2008, to perform the TEV inspection, FPI, and ECI.
    (2) For Tier 3 fan disks, listed by P/N, SN, and Tier in Table 1
of GE ASB No. CF34-AL S/B 72-A0233, Revision 04, dated October 27,
2008; already inspected using GE ASB No. CF34-AL S/B 72-A0233,
Revision 03, dated June 27, 2007, or earlier issue, perform a TEV
inspection and an ECI on the Tier 3 fan disks at the next shop
visit. Use paragraph 3.A of the Accomplishment Instructions of GE
ASB CF34-AL S/B 72-A0253, dated October 27, 2008, to perform the TEV
inspection and ECI.
    (3) Repetitive ECI on the Tier 3 fan disks are not required.

Inspections of Tier 1 Fan Disks

    (k) For CF34-1A turbofan engines with fan drive shaft, P/N
6036T78P02, and airworthiness limitation section life limit of
15,000 CSN, CF34-3A, CF34-3A2, and CF34-3B turbofan engines with
Tier 1 fan disks listed by P/N, SN, and Tier in Table 1 of GE ASB
No. CF34-BJ S/B 72-A0212, Revision 04, dated October 27, 2008, do
the following:

TEV Inspections, FPI, and ECI

    (1) For Tier 1 fan disks not already inspected using GE ASB No.
CF34-BJ S/B 72-A0212, Revision 03, dated June 27, 2007, or earlier
issue:
    (i) Perform a TEV inspection, FPI, and ECI on the Tier 1 fan
disks within 350 CIS after the effective date of this AD. Use
paragraph 3.A of the Accomplishment Instructions of GE ASB CF34-BJ
S/B 72-A0212, Revision 04, dated October 27, 2008, to perform the
TEV inspection.
    (ii) Thereafter, perform repetitive ECI on the Tier 1 fan disks
within intervals of 3,000 CSLI. Use paragraph 3.A of the
Accomplishment Instructions of GE ASB CF34-BJ S/B 72-A0235, dated
October 27, 2008, to perform the repetitive ECI.
    (2) For Tier 1 fan disks, listed by P/N, SN, and Tier in Table 1
of GE ASB No. CF34-BJ S/B 72-A0212, Revision 04, dated October 27,
2008; already inspected using GE ASB No. CF34-BJ S/B 72-A0212,
Revision 03, dated June 27, 2007, or earlier issue, do the
following:
    (i) For Tier 1 fan disks with 2,500 or more CSLI on the
effective date of this AD, perform an ECI on the Tier 1 fan disks
within 500 CIS after the effective date of this AD. Use paragraph
3.A of the Accomplishment Instructions of GE ASB CF34-BJ S/B 72-
A0235, dated October 27, 2008, to perform the ECI.
    (ii) For Tier 1 fan disks with fewer than 2,500 CSLI on the
effective date of this AD, perform an ECI on the Tier 1 fan disks
within 3,000 CSLI after the effective date of this AD. Use paragraph
3.A of the Accomplishment Instructions of GE ASB CF34-BJ S/B 72-
A0235, dated October 27, 2008, to perform the ECI.
    (iii) Thereafter, perform repetitive ECI on the Tier 1 fan disks
within intervals of 3,000 CSLI. Use paragraph 3.A of the
Accomplishment Instructions of GE ASB CF34-AL S/B 72-A0235, dated
October 27, 2008, to perform the repetitive ECI.

Inspections of Tier 2 Fan Disks

    (l) For CF34-1A turbofan engines with fan drive shaft, P/N
6036T78P02, and airworthiness limitation section life limit of
15,000 CSN, CF34-3A, CF34-3A2, and CF34-3B turbofan engines with
Tier 2 fan disks listed by P/N, SN, and Tier in Table 1 of GE ASB
No. CF34-AL S/B 72-A0212, Revision 04, dated October 27, 2008, do
the following:

TEV Inspections, FPI, and ECI

    (1) For Tier 2 fan disks not already inspected using GE ASB No.
CF34-AL S/B 72-A0212, Revision 03, dated June 27, 2007, or earlier
issue, do the following:
    (i) Perform a TEV inspection, FPI, and ECI on the Tier 2 fan
disks within 2,000 CIS after the effective date of this AD, or
within 3,500 CIS after September 12, 2007, or by March 19, 2012,
whichever occurs first. Use paragraph 3.A of the Accomplishment
Instructions of GE ASB CF34-BJ S/B 72-A0212, Revision 04, dated
October 27, 2008, to perform the TEV inspection, FPI, and ECI.
    (ii) Thereafter, perform repetitive ECI on the Tier 2 fan disks
within intervals of 3,000 CSLI. Use paragraph 3.A of the
Accomplishment Instructions of GE ASB CF34-BJ S/B 72-A0235, dated
October 27, 2008, to perform the repetitive ECI.
    (2) For Tier 2 fan disks, listed by P/N, SN, and Tier in Table 1
of GE ASB No. CF34-BJ S/B 72-A0212, Revision 04, dated October 27,
2008; already inspected using GE ASB

No. CF34-BJ S/B 72-A0212, Revision 03, dated June 27, 2007, or
earlier issue, do the following:
    (i) For Tier 2 fan disks with 2,500 or more CSLI on the
effective date of this AD, perform an ECI on the Tier 2 fan disks
within 500 CIS after the effective date of this AD. Use paragraph
3.A of the Accomplishment Instructions of GE ASB CF34-BJ S/B 72-
A0235, dated October 27, 2008, to perform the ECI.
    (ii) For Tier 2 fan disks with fewer than 2,500 CSLI on the
effective date of this AD, perform an ECI on the Tier 2 fan disks
within 3,000 CSLI. Use paragraph 3.A of the Accomplishment
Instructions of GE ASB CF34-BJ S/B 72-A0235, dated October 27, 2008,
to perform the ECI.
    (iii) Thereafter, perform repetitive ECI on the Tier 2 fan disks
within intervals of 3,000 CSLI. Use paragraph 3.A of the
Accomplishment Instructions of GE ASB CF34-BJ S/B 72-A0235, dated
October 27, 2008, to perform the repetitive ECI.

Inspections of Tier 3 Fan Disks

    (m) For CF34-1A turbofan engines with fan drive shaft, P/N
6036T78P02, and airworthiness limitation section life limit of
15,000 CSN, CF34-3A, CF34-3A2, and CF34-3B turbofan engines with
Tier 3 fan disks listed by P/N, SN, and Tier in Table 1 of GE ASB
No. CF34-BJ S/B 72-A0212, Revision 04, dated October 27, 2008, do
the following:

TEV Inspections, FPI, and ECI

    (1) For Tier 3 fan disks not already inspected using GE ASB No.
CF34-AL S/B 72-A0212, Revision 03, dated June 27, 2007, or earlier
issue, perform a TEV inspection, FPI, and ECI on the Tier 3 fan
disks within 3,500 CIS after September 12, 2007, or by March 19,
2012, whichever is earlier. Use paragraph 3.A of the Accomplishment
Instructions of GE ASB CF34-AL S/B 72-A0234, dated October 27, 2008,
to perform the TEV inspection, FPI, and ECI.
    (2) For Tier 3 fan disks, listed by P/N, SN, and Tier in Table 1
of GE ASB No. CF34-BJ S/B 72-A0212, Revision 04, dated October 27,
2008; already inspected using GE ASB No. CF34-BJ S/B 72-A0212,
Revision 03, dated June 27, 2007, or earlier issue, perform a TEV
inspection and an ECI on the Tier 3 fan disks within 3,500 CSLI, but
no later than March 19, 2012. Use paragraph 3.A of the
Accomplishment Instructions of GE ASB CF34-BJ S/B 72-A0234, dated
October 27, 2008, to perform the TEV inspection and ECI.
    (3) Repetitive ECI on the Tier 3 fan disks are not required.

Alternative Methods of Compliance

    (n) The Manager, Engine Certification Office, has the authority
to approve alternative methods of compliance for this AD if
requested using the procedures found in 14 CFR 39.19.

Mandatory Terminating Action

    (o) Remove from service, Tier 1 and Tier 2 fan disks listed by
P/N, SN, and Tier in Table 1 of GE ASB No. CF34-AL S/B 72-A0233,
Revision 04, dated October 27, 2008; or CF34-BJ S/B 72-0212,
Revision 04, dated October 27, 2008, before they exceed their
limited life cycles or September 30, 2018, whichever occurs first.

Related Information

    (p) Contact Tara Chaidez, Aerospace Engineer, Engine
Certification Office, FAA, Engine and Propeller Directorate, 12 New
England Executive Park, Burlington, MA 01803; e-mail:
<EMAIL_ADDRESS>telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>,
for more information about this AD.
    (q) The following GE Alert Service Bulletins pertain to the
subject of this AD:
     CF34-AL S/B 72-A0233, Revision 04, dated October 27,
2008,
     CF34-AL S/B 72-A0252, dated October 27, 2008,
     CF34-AL S/B 72-A0253, dated October 27, 2008,
     CF34-BJ S/B 72-A0212, Revision 04, dated October 27,
2008,
     CF34-BJ S/B 72-A0234, dated October 27, 2008, and
     CF34-BJ S/B 72-A0235, dated October 27, 2008.
    Contact General Electric Company via Lockheed Martin Technology
Services, 10525 Chester Road, Suite C, Cincinnati, Ohio 45215;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>, for a copy of this
service information.

    Issued in Burlington, Massachusetts, on April 9, 2009.
Peter A. White,
Assistant Manager, Engine and Propeller Directorate, Aircraft
Certification Service.
[FR Doc. E9-8787 Filed 4-16-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register: September 14, 2010 (Volume 75, Number 177)]
[Notices]
[Page 55810]
[DOCID:fr14se10-93]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0425]

Withdrawal of Approval of New Animal Drug Applications;
Chloramphenicol, Lincomycin, Pyrantel Tartrate, and Tylosin Phosphate
and Sulfamethazine

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of four new animal drug applications (NADAs). In a final rule published
elsewhere in this issue of the Federal Register, FDA is amending the
regulations to remove portions reflecting approval of these NADAs.

DATES:  Withdrawal of approval is effective September 24, 2010.

FOR FURTHER INFORMATION CONTACT: John Bartkowiak, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: John J. Ferrante, 11 Fairway Lane, Trumbull,
CT 06611; International Nutrition, Inc., 7706 ``I'' Plaza, Omaha, NE
68127; and Feed Service Co., Inc., 303 Lundin Blvd., P.O. Box 698,
Mankato, MN 56001 have requested that FDA withdraw approval of the four
NADAs listed in table 1 because they are no longer manufactured or
marketed:

                                Table 1.
------------------------------------------------------------------------
                           NADA Number Product          21 CFR Cite
        Sponsor            (Established Name of       (Sponsor's Drug
                                  Drug)                Labeler Code)
------------------------------------------------------------------------
John J. Ferrante, 11    NADA 65-137 AMPHICOL-V     Sec.   520.390b
 Fairway Lane,           Capsules                   (058034)
 Trumbull, CT 06611      (chloramphenicol)
------------------------------------------------------------------------
International           NADA 121-337 INI Swine     Sec.   558.485
 Nutrition, Inc., 7706   Ban-Wormer B-9.6 BA.       (043733)
 ``I'' Plaza, Omaha,     (pyrantel tartrate)
 NE 68127
------------------------------------------------------------------------
International           NADA 132-923 LINCO 8/      Sec.   558.325
 Nutrition, Inc., 7706   LINCO 20 (lincomycin)      (043733)
 ``I'' Plaza, Omaha,
 NE 68127
------------------------------------------------------------------------
Feed Service Co.,       NADA 138-342 TYLAN 5       Sec.   558.630
 Inc., 303 Lundin        Sulfa-G Premix (tylosin    (030841)
 Blvd., P.O. Box 698,    and sulfamethazine)
 Mankato, MN 56001
------------------------------------------------------------------------

    Therefore, under authority delegated to the Commissioner of Food
and Drugs and redelegated to the Center for Veterinary Medicine, and in
accordance with Sec.  514.116 Notice of withdrawal of approval of
application (21 CFR 514.116), notice is given that approval of NADAs
65-137, 121-337, 132-923, and 138-342, and all supplements and
amendments thereto, is hereby withdrawn, effective September 24, 2010.
    In a final rule published elsewhere in this issue of the Federal
Register, FDA is amending the animal drug regulations to reflect the
withdrawal of approval of these NADAs.

    Dated: September 1, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-22809 Filed 9-13-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register: November 29, 2010 (Volume 75, Number 228)]
[Notices]
[Page 73107-73108]
[DOCID:fr29no10-105]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0590]

Guidance for Industry and Food and Drug Administration Staff;
Blood Lancet Labeling; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Guidance for Industry and Food
and Drug Administration Staff; Blood Lancet Labeling.'' FDA is issuing
this guidance with labeling recommendations because of concerns that
both healthcare providers and patients may be unaware of the serious
adverse health risks associated with using the same blood lancet device
for assisted withdrawal of blood from more than one patient, even when
the lancet blade is changed for each blood draw. FDA recommends that
all blood lancet devices be labeled for use only on a single patient. A
statement limiting use to a single patient should also appear on the
label attached to the device, if possible. The guidance document is
immediately in effect, but it remains subject to comment in

accordance with the Agency's good guidance practices.

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.

ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Guidance for Industry and Food and Drug
Administration Staff; Blood Lancet Labeling'' to the Division of Small
Manufacturers, International, and Consumer Assistance, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your request, or fax your request to<PHONE_NUMBER>. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance.
    Submit electronic comments on the guidance to http://
www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Shelia Murphey, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2510, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On August 26, 2010, the FDA and Centers for Disease Control and
Prevention (CDC) issued a joint Initial Communications warning that the
use of fingerstick devices (blood lancets) to obtain blood from more
than one patient poses a risk of transmitting bloodborne pathogens. The
Agencies recommended that blood lancet devices should never be used to
obtain blood samples from more than one person.
    CDC has noted a progressive increase in reports of bloodborne
pathogen transmission (primarily hepatitis B) resulting from the use of
a blood lancet in multiple patients in various healthcare provision
settings. These settings include acute care hospitals, long term care
facilities and assisted living facilities as well as non-residential
care settings.
    Blood lancet devices may be unsafe when used to draw blood from
more than one patient for several reasons. Improper device design,
device malfunction, or user error may leave the blood from one patient
on the reusable lancet device base and in a position to contaminate a
new lancet blade. Healthcare users of blood lancets may have difficulty
ensuring that all blood contamination has been successfully removed
from a reusable lancet base device. The cleaning and disinfection
instructions provided with reusable lancet devices may not be
adequately validated for efficacy or followed in their entirety. FDA
recommends that all blood lancet devices be labeled for use only on a
single patient. A statement limiting use to a single patient should
also appear on the label attached to the device, if possible.
    FDA is making this guidance document immediately available because
prior public participation is not appropriate. Due to the urgent public
health need to support the joint Initial Communications issued by CDC
and FDA concerning the risk of hepatitis transmission caused by the use
of blood lancets on more than one patient, FDA believes that current
lancet labeling which does not restrict the use of lancets to a single
patient must be corrected as quickly as possible. FDA believes that
this guidance will provide significant assistance to lancet
manufacturers as they work to improve their labeling as recommended.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on blood lancet labeling. It does not create
or confer any rights for or on any person and does not operate to bind
FDA or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
using the Internet. A search capability for all CDRH guidance documents
is available at http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. To receive
``Guidance for Industry and Food and Drug Administration Staff; Blood
Lancet Labeling,'' you may either send an e-mail request to
<EMAIL_ADDRESS>to receive an electronic copy of the document or
send a fax request to<PHONE_NUMBER> to receive a hard copy. Please use
the document number 1732 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collection of information in this guidance was approved under OMB
control number 0910-0485.

V. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: November 22, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-29795 Filed 11-26-10; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: November 6, 2007 (Volume 72, Number 214)]
[Rules and Regulations]
[Page 62566-62568]
[DOCID:fr06no07-5]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-28925; Directorate Identifier 2007-NM-123-AD;
Amendment 39-15248; AD 2007-23-02]
RIN 2120-AA64

Airworthiness Directives; Airbus Model A330-200 and -300 Series
Airplanes, and Model A340-200 and -300 Series Airplanes

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

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing
airworthiness information (MCAI) originated by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    During ground inspection of an A340-311 aircraft, it has been
discovered that 5 fasteners were missing between Frame (FR) 18 and
FR19 on longitudinal joint at stringer 28RH (right hand).

    Further investigations have revealed that the missing fasteners
have not been installed in production due to incorrect production
instructions.

    If not corrected, this situation could affect the structural
integrity of the aircraft in the area of stringer 28 between FR18
and FR19 at longitudinal joint.

We are issuing this AD to require actions to correct the unsafe
condition on these products.

DATES: This AD becomes effective December 11, 2007.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of December 11,
2007.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov
 or in person at the U.S. Department of

Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Tim Backman, Aerospace Engineer,
International Branch, ANM-116, FAA, Transport Airplane Directorate,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-2797; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on August 16, 2007 (72
FR 45970). That NPRM proposed to correct an unsafe condition for the
specified products. The MCAI states:

    During ground inspection of an A340-311 aircraft, it has been
discovered that 5 fasteners were missing between Frame (FR) 18 and
FR19 on longitudinal joint at stringer 28RH (right hand).

    Further investigations have revealed that the missing fasteners
have not been installed in production due to incorrect production
instructions.

    If not corrected, this situation could affect the structural
integrity of the aircraft in the area of stringer 28 between FR18
and FR19 at longitudinal joint.

    In order to re-establish the structural strength of the
aircraft, this Airworthiness Directive (AD) renders mandatory the
inspection of the longitudinal joint at stringer 28 RH between FR18
and FR19 [for missing fasteners].

For airplanes on which any fastener is missing, the corrective actions
include doing a detailed visual inspection for cracking of the adjacent
fastener area from the outside, without removing the fasteners; and if
no crack is found, doing a rotating probe inspection for cracks of the
adjacent fastener holes after removing the fasteners, and replacing any
missing fastener. The corrective actions also include contacting Airbus
for repair instructions and repair if fasteners are not at nominal
diameter or if any crack is found. You may obtain further information
by examining the MCAI in the AD docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM or on the determination of
the cost to the public.

Conclusion

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

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow our FAA policies. Any such differences
are highlighted in a NOTE within the AD.

Costs of Compliance

    We estimate that this AD will affect about 9 products of U.S.
registry. We also estimate that it will take about 4 work-hours per
product to comply with the basic requirements of this AD. The average
labor rate is $80 per work-hour. Based on these figures, we estimate
the cost of this AD to the U.S. operators to be $2,880, or $320 per
product.

Authority for This Rulemaking

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

Regulatory Findings

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

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov
; or in person at the Docket Operations office

between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Operations office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2007-23-02 Airbus: Amendment 39-15248. Docket No. FAA-2007-28925;
Directorate Identifier 2007-NM-123-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective December
11, 2007.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Airbus Model A330-200 and -300 series
airplanes and Model A340-200 and -300 series airplanes; certificated
in any category; all manufacturer's serial numbers (MSN) up to MSN
0402 included, except MSN 051.

Subject

    (d) Air Transport Association (ATA) of America Code 53:
Fuselage.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    During ground inspection of an A340-311 aircraft, it has been
discovered that 5 fasteners were missing between Frame (FR) 18 and
FR19 on longitudinal joint at stringer 28RH (right hand).

    Further investigations have revealed that the missing fasteners
have not been installed in production due to incorrect production
instructions.

    If not corrected, this situation could affect the structural
integrity of the aircraft in the area of stringer 28 between FR18
and FR19 at longitudinal joint.

    In order to re-establish the structural strength of the
aircraft, this Airworthiness Directive (AD) renders mandatory the
inspection of the longitudinal joint at stringer 28 RH between FR18
and FR19 [for missing fasteners].

For airplanes on which any fastener is missing, the corrective
actions include doing a detailed visual inspection for cracking of
the adjacent fastener area from the outside, without removing the
fasteners; and if no crack is found, doing a rotating probe
inspection for cracks of the adjacent fastener holes after removing
the fasteners, and replacing any missing fastener. The corrective
actions also include contacting Airbus for repair instructions and
repair if fasteners are not at nominal diameter or if any crack is
found.

Actions and Compliance

    (f) Before the accumulation of 14,000 flight cycles from the
first flight of the aircraft, or within 1,500 flight cycles
following the effective date of this AD, whichever occurs later,
unless already done, do the following actions: Perform a detailed
visual inspection of the longitudinal joint at stringer 28 RH
between FR18 and FR19 for missing fasteners, and do all applicable
corrective actions before further flight, in accordance with the
instructions defined in Airbus Service Bulletin A330-53-3170 or
A340-53-4175, both dated March 27, 2007.

FAA AD Differences

    Note: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. Send information to ATTN: Tim Backman, Aerospace Engineer,
International Branch, ANM-116, FAA, Transport Airplane Directorate,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425) 227-2797; fax<PHONE_NUMBER>. Before using any approved AMOC
on any airplane to which the AMOC applies, notify your appropriate
principal inspector (PI) in the FAA Flight Standards District Office
(FSDO), or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act, the
Office of Management and Budget (OMB) has approved the information
collection requirements and has assigned OMB Control Number 2120-
0056.

Related Information

    (h) Refer to MCAI European Aviation Safety Agency Airworthiness
Directive 2007-0125, dated May 4, 2007, and Airbus Service Bulletins
A330-53-3170 and A340-53-4175, both dated March 27, 2007, for
related information.

Material Incorporated by Reference

    (i) You must use the service information specified in Table 1 of
this AD to do the actions required by this AD, unless the AD
specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Airbus, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France.
    (3) You may review copies at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington; or at the
National Archives and Records Administration (NARA). For information
on the availability of this material at NARA, call<PHONE_NUMBER>,
or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html
.

              Table 1.--Material Incorporated by Reference
------------------------------------------------------------------------
               Airbus Service Bulletin                       Date
------------------------------------------------------------------------
A330-53-3170, excluding Appendix 01.................     March 27, 2007.
A340-53-4175, excluding Appendix 01.................     March 27, 2007.
------------------------------------------------------------------------

    Issued in Renton, Washington, on October 27, 2007.
Stephen P. Boyd,
Assistant Manager, Transport Airplane Directorate, Aircraft
Certification Service.
 [FR Doc. E7-21686 Filed 11-5-07; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 78 (Friday, April 22, 2022)]
[Notices]
[Page 24174]
[FR Doc No: 2022-08587]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-0957]

Compliance Policy Guides Sec. 335.500; Sec. 310.200; Sec.
393.100; Sec. 398.425; Sec. 394.500; Sec. 300.750; Withdrawal of
Guidance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the withdrawal of six compliance policy guides (CPG). The Agency is
taking this action because the CPGs identified in this notice contain
information that is either duplicative of other information the Agency
has published or no longer reflects the Agency's current thinking.

DATES: The withdrawal is effective April 22, 2022.

FOR FURTHER INFORMATION CONTACT: Erica Takai, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5456, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    After careful review of CPGs related to device products, FDA has
identified the following six CPGs, that contain information that is
either duplicative or no longer reflects the Agency's current thinking.
    FDA originally issued CPG Sec. 335.500, ``Razor Blades, Manicuring
Instruments--Not Considered Devices Under 201(h)'' (CPG Sec. 335.500)
in April 1976. The CPG was revised periodically but has not been
revised since March 1995. Given the time that has passed since the last
revision of CPG Sec. 335.500, upon further review, FDA has determined
that while the CPG still reflects the Agency's current thinking, it is
no longer needed because it appears to be seldomly accessed.
    CPG Sec. 310.200, ``Sphygmomanometers--Rx Legend'' (CPG Sec.
310.200) was originally issued in January 1973. The CPG was revised
periodically but has not been revised since September 1987. Since CPG
Sec. 310.200 was last updated, many of these products have been cleared
to be sold over the counter and therefore, the policy contained in this
CPG is obsolete and no longer needed.
    CPG Sec. 393.100, ``Enforcement Policy for Certain Laser Light
Shows, Displays, and/or Devices. (21 CFR 1040.10 and 1040.11)'' (CPG
Sec 393.100) was originally issued in October 1980. The CPG was revised
periodically but has not been revised since March 2005. Since CPG Sec.
393.100 was last revised, the policies regarding these products have
been updated and additional resources have been made available to the
public regarding these products, including in four laser notice
guidance documents.\1\ The change in policies and the availability of
additional resources has resulted in the information contained within
CPG Sec. 393.100 to be duplicative and outdated.
---------------------------------------------------------------------------

    \1\ See https://www.fda.gov/radiation-emitting-products/home-business-and-entertainment-products/laser-light-shows.
---------------------------------------------------------------------------

    CPG Sec. 398.425, ``Override of Positive Beam Limitation--21 CFR
1020.31(g)(5)'' (CPG Sec. 398.425) was originally issued in October
1980. The CPG was revised periodically but has not been revised since
March 2005. Given the time that has passed since the last revision of
CPG Sec. 398.425, upon further review, FDA has determined that the CPG
provides duplicative information to what is provided in 21 CFR
1020.31(g)(5).
    CPG Sec. 394.500, ``Importation of Television Products, Microwave
Ovens, and Inherent Class I Laser Products for Investigation and
Evaluation during Design Development'' (CPG Sec. 394.500) was
originally issued in March 1984. The CPG was revised periodically but
has not been revised since July 2004. Given the time that has passed
since the last revision of CPG Sec. 394.500, upon further review, FDA
has determined that the CPG contains outdated information and
references.
    Finally, CPG Sec. 300.750, ``Class III Devices Subject to 515(b)
Requirements'' (CPG Sec. 300.750) was originally issued in October
1990. The CPG was revised periodically but has not been revised since
July 2005. Since CPG Sec. 300.750 was last revised, FDA has completed
the actions for the preamendment class III devices discussed in the CPG
to either reclassify them into class I, or II, or, if retaining the
device in class III, calling for PMAs; \2\ as such, the CPG is
obsolete.
---------------------------------------------------------------------------

    \2\ See https://www.fda.gov/about-fda/cdrh-transparency/515-program-initiative and https://www.fda.gov/about-fda/cdrh-transparency/515-project-status.
---------------------------------------------------------------------------

    Therefore, after careful review, FDA is withdrawing CPG Sec.
335.500, CPG Sec. 310.200, 393.100, CPG Sec. 398.425, CPG Sec. 394.500,
and CPG Sec. 300.750 in their entirety because the CPGs are either
obsolete or contain duplicative information.

    Dated: April 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-08587 Filed 4-21-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 184 (Thursday, September 22, 2016)]
[Notices]
[Pages 65462-65463]
[FR Doc No: 2016-22826]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Twentieth RTCA SC-223 Aeronautical Mobile Airport Communication
System Plenary Calling Notice

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

ACTION: Twentieth RTCA SC-223 Aeronautical Mobile Airport Communication
System Plenary Calling Notice.

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

SUMMARY: The FAA is issuing this notice to advise the public of a
meeting of Twentieth RTCA SC-223 Aeronautical Mobile Airport
Communication System Plenary Calling Notice.

DATES: The meeting will be held November 08-09, 2016, 09:00 a.m.-05:00
p.m. and November 10, 2016 09:00 a.m.-12:00 p.m.

ADDRESSES: The meeting will be held at: RTCA Headquarters, 1150 18th
Street NW., Suite 910, Washington, DC 20036.

FOR FURTHER INFORMATION CONTACT: Rebecca Morrison at<EMAIL_ADDRESS>or<PHONE_NUMBER>, or The RTCA Secretariat, 1150 18th Street NW., Suite
910, Washington, DC 20036, or by telephone at<PHONE_NUMBER>, fax at
(202) 833-9434, or Web site at http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for a meeting of the Twentieth RTCA SC-223 Aeronautical
Mobile Airport Communication System Plenary Calling Notice. The agenda
will include the following:

November 8 & 9, 9:00 a.m. to 5:00 p.m., November 10, 9:00 a.m. to 12:00
p.m.

1. Welcome, Introductions, Administrative Remarks
2. Review of Previous Meeting Notes and Action Items
3. Review of Current State of Industry Standards
    a. ICAO WG-I
    b. AEEC IPS Sub Committee
4. Current State of Industry Activities
    a. SESAR Programs
    b. ESA IRIS Precursor
    c. Any Other Activities
5. IPS Technical Discussions
    a. Review of Profiling Report on IPv6 Functions and Corresponding
RFCs
    b. Review of IPS RFC Profiles
    c. Prioritization of Additional IETF RFCs for Profiling
6. Any Other Topics of Interest
7. Plans for Next Meetings
8. Review of Action Items and Meeting Summary

9. Adjourn

    Attendance is open to the interested public but limited to space
availability. With the approval of the chairman, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on September 19, 2016.
Mohannad Dawoud,
Management & Program Analyst, Partnership Contracts Branch, ANG-A17
NextGen, Procurement Services Division, Federal Aviation
Administration.
[FR Doc. 2016-22826 Filed 9-21-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 151 (Tuesday, August 8, 2023)]
[Notices]
[Pages 53580-53581]
[FR Doc No: 2023-16950]

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

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2023-0051]

Petition for Waiver of Compliance

    Under part 211 of title 49 Code of Federal Regulations (CFR), this
document provides the public notice that on July 7, 2023,
TransitAmerica Services, Inc. (TASI), the operations contractor to
Metrolink Arrow SCAX, petitioned the Federal Railroad Administration
(FRA) for a waiver of

compliance from certain provisions of the Federal railroad safety
regulations contained at 49 CFR part 240 (Qualification and
Certification of Locomotive Engineers) and part 242 (Qualification and
Certification of Conductors). FRA assigned the petition Docket Number
FRA-2023-0051.
    Specifically, TASI requests relief required to participate in FRA's
Confidential Close Call Reporting System (C\3\RS) Program. TASI seeks
to shield reporting employees from mandatory punitive sanctions that
would otherwise arise as provided in Sec. Sec.  240.117(e)(1)-(4);
240.305(a)(1)-(4) and (a)(6); 240.307; 242.403(b), (c), (e)(1)-(4),
(e)(6)-(11), (f)(1)-(2); and 242.407. The C\3\RS Program encourages
certified operating crew members to report close calls and protects the
employees and the railroad from discipline or sanctions arising from
the incidents reported per the C\3\RS Implementing Memorandum of
Understanding.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested parties
desire an opportunity for oral comment and a public hearing, they
should notify FRA, in writing, before the end of the comment period and
specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted at http://www.regulations.gov. Follow the online instructions for submitting
comments.
    Communications received by October 10, 2023 will be considered by
FRA before final action is taken. Comments received after that date
will be considered if practicable.
    Anyone can search the electronic form of any written communications
and comments received into any of our dockets by the name of the
individual submitting the comment (or signing the document, if
submitted on behalf of an association, business, labor union, etc.).
Under 5 U.S.C. 553(c), DOT solicits comments from the public to better
inform its processes. DOT posts these comments, without edit, including
any personal information the commenter provides, to
www.regulations.gov, as described in the system of records notice (DOT/
ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacy-notice for the
privacy notice of regulations.gov.

    Issued in Washington, DC.
John Karl Alexy,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2023-16950 Filed 8-7-23; 8:45 am]
BILLING CODE P


Uncertainty FactorsIRationale: Total uncertainty application of 10. The interspecies uncertainty factor was limited to 3 because of the concordance of the animal data with the human experience and because the most sensitive species tested (guinea pig) was only about 2 fold more sensitive. The intraspecies uncertainty factor was limited to 3 because primary effects of phosphorus trichloride (irritation and subsequent tissue damage) appear to be due, in part, to hydrogen chloride and phosphonic acid resulting from chemical dissociation. Furthermore, the AEGL 1 is based upon a conservative assumption and additional reduction of the AEGL 1 values would be inconsistent with available human and animal data.

Modifying Factor: Not applicable Animal to Human Dosimetric Adjustments: Not applicable Data Quality and Support of the AEGL Values: Neither human nor animal quantitative exposure response data are available regarding effects consistent with AEGL 1 definition.. The 3.4 ppm exposure of rats over 4 weeks was selected as a NOAEL for AEGL 1. Although likely to be a conservative basis for developing AEGL 1 values, it may be justified due to the relative paucity of data on the toxic response to this chemical. PHOSPHORUS TRICHLORIDE 1 26 PROPOSED 1: 05/ 2002 000274 1 2 3 4 5 6 7 8 9 10 1 1 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 10 minutes PHOSPHORUS TRICHLORIDE PROPOSED 1: 05/ 2002 ACUTE EXPOSURE GUIDELINES FOR PHOSPHORUS TRICHLORIDE (CAS NO. 7719 12 2)

30 minutes I 1 hour I 4 hours I 8 hours 2.5 ppm 2.5 ppm 2.0 ppm 1.3 ppm 0.83 ppm I I I ~

Test Species/ Strain/ Number: Sprague Dawley rats; 1 5/ sex/ group Exposure Route/ Concentrations/ Durations: Inhalation exposure (whole body) to 0,0.5,3.0, or 10.0 ppm (nominal) for 6 hrsfday, 5 daydweek for 4 weeks Toxicity Endpoint: Histopathologic alterations in respiratory tract in rats exposed to 11 ppm (analytical), 6 hrs/ day, 5 daysfweek for 4 weeks. There were no concurrent hematologic or biochemical alterations indicative of a toxic response, and there were no ophthalmologic effects.

Time Scaling: The concentration time relationship for may irritant and systemically acting vapors and gases may be described by C" x t = k , where the exponent n ranges from 0.8 to 3.5. Due to the limited toxicity data for this chemical, an empirical derivation of n was not possible. In the absence of an empirically derived exponent (n), and to obtain conservative and protective AEGL values, temporal scaling was performed using n = 3 when extrapolating to shorter time points and n = 1 when extrapolating to longer time points using the C" x t = k equation. For 10 minute AEGL 2, values were set at equivalence to the 30 minute values due to uncertainties in extrapolating from the experimental exposure durations of 4 hours or greater.

Concentration/ Time SelectiodRationale: The multiple exposure of rats to 11 ppm over 4 weeks was considered a conservative estimate and NOAEL for AEGL 2 effects (i. e., the effects were neither disabling nor irreversible).

Uncertainty Factors/ Rationale: Total uncertainty application of 10. The interspecies uncertainty factor was limited to 3 because of the concordance of the animal data with the human experience and because the most sensitive species tested (guinea pig) was only about 2 fold more sensitive. The intraspecies uncertainty factor was limited to 3 because primary effects of phosphorus trichloride (irritation and subsequent tissue damage) appear to be due, in part, to hydrogen chloride and phosphonic acid resulting from chemical dissociation. Furthermore, the AEGL 2 is based upon a histopathologic changes in the respiratory tract which were not necessarily irreversible or disabling. Additional reduction of the AEGL 2 values would be inconsistent with available human and animal data.

Modifying Factor: Not Applicable Animal to Human Dosimetric Adjustments: Not applicable 27 000275 6 PHOSPHORUS TRICHLORIDE PROPOSED 1: 092002 Data Quality and Support of the AEGL Values: Limited information regarding the human experience indicated that 2 to 6 hour exposures to 1.8 3.6 ppm were without effect and that exposure to 14 27 ppm irritation of the eyes and upper respiratory tract, photophobia, chest tightness, and bronchitis. Because the effects were neither disabling nor irreversible, the endpoint used for AEGL 2 development is considered a NOAEL for AEGL 2 effects.

28 000276 PHOSPHORUS TRICHLORIDE PROPOSED 1: 092002 1 2 3 4 5 6 7 S 9 10 11 12 13 14 15 16 17 `1 s 19 20 21 22 23 24 25 26 27 2s 29 30 31 32 33 34 35 36 37 3s 39 40 ACUTE EXPOSURE GUIDELINES FOR PHOSPHORUS TRICHLORIDE (CAS NO. 7719 12 2)

AEGL 3 VALUES 10 minutes 30 minutes 1 hour 4 hours 8 hours 3.3 ppm 3.3 ppm 2.7 ppm 1.7 ppm 0.84 ppm Reference: Weeks, M. H., Mussleman, N. P., Yevich, P. P., Jacobson, K. H., Oberst, F. W. 1964. Acute vapor toxicity of phosphorus oxychloride, phosphorus trichloride and methyl phosphonic dichloride. Amer. Ind. Hyg. J. 25: 470 475.

Test Species/ Strain/ Number: female rats and guinea pigdstrain not specified20 per group Exposure Route/ Concentrations/ Durations: inhalatiordmedian lethal concentrations derived but exposure concentrations not specified4 hrs Toxicity Endpoint: guinea pig 4 hr LC,, of 50.1 ppm Time Scaling: The concentration time relationship for may irritant and systemically acting vapors and gases may be described by C` x t = k , where the exponent n ranges from 0.8 to 3.5. Due to the limited toxicity data for this chemical, an empirical derivation of n was not possible. In the absence of an empirically derived exponent (n), and to obtain conservative and protective AEGL values, temporal scaling was performed using n = 3 when extrapolating to shorter time points and n = 1 when extrapolating to longer time points using the C` x t = k equation. (16.7 ppm) ' x 4 hrs = 66.8 ppm hrs (n = 1 ) (16.7 ~p m )~ x 4 hrs = 18,629.85 ppm3 hrs (n = 3)

ConcentratiordTime SelectiodRationale: a 3 fold reduction of the guinea pig 4 hr LC,, (50.1 ppm/ 3 = 16.7 ppm) was used as an estimate of the lethality threshold.

Uncertainty FactodRationale: Total Uncertainty: 10 Interspecies UF = 3 Data for humans and animals indicate some variability in the toxic response to phosphorus trichloride but guinea pigs appear to be the more sensitive among the species tested. The uncertainty for intraspecies variability was limited to 3 because primary effects of phosphorus trichloride (irritation and subsequent tissue damage) appear to be due, in part, to hydrogen chloride and phosphonic acid resulting from chemical dissociation and the direct corrosive action of these on epithelial tissue. The overall uncertainty factor adjustment of 10 may be justified by limited human exposure data suggesting that humans could experience exposures of up to 27 ppm without life threatening consequences. Furthermore, the results of a study in rats exposed to 11 ppm 6 hrs/ day, 5 daystweek for 4 weeks showed only histologic changes in the upper respiratory tract and no overt signs of toxicity. Intraspecies UF = 3 Modifying Factor: none applied Animal to Human Dosimetric Adjustments: insufficient data 29 000277 PHOSPHORUS TRICHLORIDE PROPOSED 1: 05/ 2002 It II Data Quality and Support for the AEGL Values: Lethality data are limited to two species and quantitative data for humans are limited. However, comparison of the AEGL 3 values with available data do not support application of uncertainty adjustment greater than that currently applied. Data suitable for determining exposure time relationships are also lacking and impact on temporal extrapolation efforts. A delayed response is possible as demonstrated in the Weeks et al. (1964) study in which deaths of guinea pigs occurred up to 10 days post exposure.

I' SI 30


[Federal Register Volume 76, Number 227 (Friday, November 25, 2011)]
[Notices]
[Pages 72736-72738]
[FR Doc No: 2011-30284]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65791; File No. SR-FINRA-2011-053]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Order Granting Approval of Proposed Rule Change to
Amend Certain TRACE Rules

November 18, 2011.

I. Introduction

    On September 22, 2011, the Financial Industry Regulatory Authority,
Inc. (``FINRA'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission''), pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934 (the ``Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to consolidate all TRACE-Eligible
Securities transaction processing and data management on a single
technology platform, the Multi Product Platform (``MPP''), and make
various changes to the rules governing how TRACE-Eligible Securities
other than Asset-Backed Securities are required to be reported. The
proposed rule change was published for comment in the Federal Register
on October 6, 2011.\3\ The Commission received two comments in response
to the proposal.\4\ On November 10, 2011, FINRA responded to the
comments.\5\ This order grants approval of the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 65459 (September 30,
2011), 76 FR 62128 (``Notice'').
    \4\ See letter from Suzanne H. Shatto, dated October 20, 2011
(``Shatto Letter''); letter from Christopher Killian, Vice
President, Securities Industry and Financial Markets Association
(``SIFMA''), to Elizabeth M. Murphy, Secretary, Commission, dated
October 27, 2011 (``SIFMA Letter'').
    \5\ See letter from Sharon Zackula, Associate Vice President and
Associate General Counsel, FINRA, to Elizabeth M. Murphy, Secretary,
Commission, dated November 10, 2011 (``FINRA Letter'').
---------------------------------------------------------------------------

II. Description of the Proposal

    Currently, transactions only in TRACE-Eligible Securities that are
Asset-Backed Securities are processed on the MPP.\6\ The proposed rule
change would make certain amendments to the reporting requirements of
Rule 6730 that would permit FINRA to migrate all other TRACE-Eligible
Securities to the MPP. These new requirements are substantially similar
to those that currently apply to transactions in Asset-Backed
Securities and are described below.
---------------------------------------------------------------------------

    \6\ ``TRACE-Eligible Security'' and ``Asset-Backed Security''
are defined in, respectively, Rule 6710(a) and Rule 6710(m).
---------------------------------------------------------------------------

TRACE-Eligible Securities Transactions Executed on a Non-Business Day

    Currently, as set forth in Rules 6730(a)(1)(D) and 6730(a)(2)(B),
transactions in TRACE-Eligible Securities, except Asset-Backed
Securities, that are executed on a weekend, holiday, or other day when
the TRACE system is not open must be reported the next business day (T
+ 1), designated ``as/of,'' and are subject to two unique requirements.
First, the date of execution (``Trade Date'') reported to TRACE is not
the actual date the trade was executed; instead, a member must report
as the Trade Date the day (i.e., T + 1) that the report must be timely
submitted. Second, the execution time reported must be ``12:01 a.m.
Eastern Time'' (``00:01:00''), instead of the actual Time of
Execution.\7\ As described in the Notice, the two requirements were
established at the inception of TRACE because, at that time, the TRACE
system did not recognize any day on which the TRACE system is closed as
a valid Trade Date, and the two current required elements allow FINRA
to distinguish transactions in TRACE-Eligible Securities executed on
non-business days from all other reported transactions.
---------------------------------------------------------------------------

    \7\ ``Time of Execution'' is defined in Rule 6710(d). Also, when
the reporting method used includes a ``special price memo'' field,
the member must enter the actual date of execution and Time of
Execution in such field.
---------------------------------------------------------------------------

    FINRA has enhanced the TRACE system to recognize, for all types of
TRACE-Eligible Securities, any calendar date as a valid Trade Date.
Accordingly, the proposed rule change would amend Rules 6730(a)(1)(D)
and 6730(a)(2)(B) to delete in both provisions the two data elements
described above, and instead require members to report transactions
executed on non-business days in the same manner that transactions
executed after or before TRACE System Hours on business days are
reported currently.\8\ The proposal also would combine and renumber
certain rules and incorporate minor technical changes.
---------------------------------------------------------------------------

    \8\ ``TRACE System Hours'' is defined in Rule 6710(t).
---------------------------------------------------------------------------

Size (Volume), Commission, and Settlement Terms

    In addition, the proposed rule change would amend the technical
requirements for reporting the size (volume) of a transaction, the
commission (if any), and the settlement of transactions in TRACE-
Eligible Securities, other than Asset-Backed Securities.
    Currently, FINRA requires members to report the size (volume) of a
transaction in a TRACE-Eligible Security, other than an Asset-Backed
Security, by reporting the number of bonds transacted.\9\ For example,
a sale of corporate bonds having a par or principal value of $10,000 is
reported as a sale of ten bonds. The proposal would amend Rules
6730(c)(2) and 6730(d)(2) to require a member to report the size of
such transactions using the total par value or principal value traded,
rather than the number of bonds.\10\
---------------------------------------------------------------------------

    \9\ See Rules 6730(c)(2) and 6730(d)(2).
    \10\ Previously, FINRA adopted similar provisions for reporting
the size (volume) of transactions in Asset-Backed Securities that do
not amortize. See Securities Exchange Act Release No. 61566
(February 22, 2010), 75 FR 9262 (March 1, 2010) (order approving
File No. SR-FINRA-2009-065).
---------------------------------------------------------------------------

    The proposed rule change would make similar change to the reporting
of commissions. Under current Rules 6730(c)(11) and 6730(d)(1), in
cases where a commission is charged in a transaction in a TRACE-
Eligible Security, the commission must be reported ``stated in points
per bond (e.g., for corporate bonds, 1 point equals $10.00 per bond).''
\11\ As amended by the proposal, Rules 6730(c)(11) and 6730(d)(1) would
require members to report the total dollar amount of the

commission, rather than the points per bond.\12\
---------------------------------------------------------------------------

    \11\ Rule 6730(d)(1).
    \12\ Previously, FINRA adopted similar provisions for reporting
a commission in a transaction in an Asset-Backed Security. See
Securities Exchange Act Release No. 61566 (February 22, 2010), 75 FR
9262 (March 1, 2010) (order approving File No. SR-FINRA-2009-065).
---------------------------------------------------------------------------

    The proposed rule change also would simplify the requirements for
reporting the settlement of a transaction in a TRACE-Eligible Security.
Currently, as provided in Rule 6730(d)(4)(B)(i), if a transaction,
other than a transaction in an Asset-Backed Security, will not settle
on T + 3, a member must report the settlement using one of three
modifiers.\13\ To streamline the requirements regarding settlement, new
Rule 6730(c)(12) would require a member simply to report the date of
settlement.\14\ In addition, the proposal would delete Rule
6730(d)(4)(B), which sets forth the three settlement modifiers that
will no longer be used in TRACE reporting, delete certain obsolete
references, and renumber certain related rules.
---------------------------------------------------------------------------

    \13\ Current Rule 6730(c)(12) will be renumbered as Rule
6730(c)(13). If a trade will not settle on T + 3, the three
modifiers that are used to indicate the day the transaction will be
settled are ``.c'' (date of execution), ``.nd'' (T + 1), or ``.sNN''
(settlement on a date other than the date of execution, T + 1 or T +
3).
    \14\ Previously, FINRA adopted a similar requirement in
connection with transactions in Asset-Backed Securities. See
Securities Exchange Act Release No. 61566 (February 22, 2010), 75 FR
9262 (March 1, 2010) (order approving File No. SR-FINRA-2009-065);
Securities Exchange Act Release No. 64364 (April 28, 2011), 76 FR
25385 (May 4, 2011) (order approving File No. SR-FINRA-2011-012).
---------------------------------------------------------------------------

    Finally, the proposed rule change would make minor technical
amendments to Rule 6730(a) through (d).
    In the Notice, FINRA stated that it would announce the effective
date of the proposed rule change in a Regulatory Notice to be published
no later than 60 days following Commission approval, and that the
effective date would be no later than 180 days following publication of
that Regulatory Notice. In its response to comments, FINRA stated that
it had several communications with its members about the migration to
the MPP.\15\ In connection with these communications, FINRA noted that,
although subject to Commission approval of the proposed rule change,
FINRA anticipates that the MPP migration would occur on February 6,
2012.\16\
---------------------------------------------------------------------------

    \15\ See FINRA Letter at note 3.
    \16\ See id.
---------------------------------------------------------------------------

III. Summary of Comments and FINRA's Response

    The Commission received two comments on the proposed rule
change.\17\
---------------------------------------------------------------------------

    \17\ See supra note 4.
---------------------------------------------------------------------------

    One commenter was generally supportive of the proposed rule change,
but raised concerns that FINRA's anticipated implementation date of
February 6, 2012 would not provide firms adequate time to develop new
systems and processes.\18\ According to the commenter, many firms have
internal information technology policies that include a year-end ``code
freeze,'' which would make it difficult to engage in development or
testing for some portion of December 2011 and/or January 2012.\19\ The
commenter requested that the MPP migration and the proposed rule
changes be implemented not earlier than the end of the first quarter of
2012.\20\
---------------------------------------------------------------------------

    \18\ See SIFMA Letter.
    \19\ See id. at 1-2.
    \20\ See id. at 2. The commenter also made minor comments
inquiring about: (1) whether both current and future reporting
systems protocols could be used simultaneously during the
transition; and (2) how certain transactions involving ``sinking
bonds'' should be reported. See id. at 2-3.
---------------------------------------------------------------------------

    In response, FINRA stated that it believed the February 6, 2012
implementation date for the proposed rule change and the MPP migration
``provides firms sufficient time to take the steps necessary to make
system and procedural changes, test and successfully convert to MPP for
reporting corporate bonds and Agency Debt Securities to TRACE.'' \21\
In support of its assertion, FINRA noted that MPP is already part of
some firms' interface with TRACE with regard to Asset-Backed Securities
reporting.\22\ Further, FINRA stated that it has provided and will
continue to provide the technical specifications that members need to
prepare for MPP migration and the implementation of the proposed rule
change.\23\
---------------------------------------------------------------------------

    \21\ See FINRA Letter at 3.
    \22\ See id.
    \23\ See id.
---------------------------------------------------------------------------

    FINRA also stated that it will continue to give guidance and
assistance to members to prepare for the MPP migration and ``will
continue to work with members to provide sufficient opportunities to
test systems'' before implementation.\24\ Finally, in arguing that the
migration of corporate bonds and Agency Debt Securities to MPP should
not be delayed, FINRA highlighted the ``significant benefits that MPP
offers regarding the processing of transactions and the management of
important TRACE data.'' \25\ FINRA responded to the commenter's request
that FINRA permit the legacy TRACE system to run in parallel with the
FIX protocols and revised CTCI protocols (used in connection with MPP)
by explaining that FINRA is not able to support these two reporting
formats simultaneously, but that if a firm has a system-related issue
during the MPP migration, the firm should contact the appropriate
department in FINRA.\26\
---------------------------------------------------------------------------

    \24\ Id. at 4.
    \25\ Id.
    \26\ See id. at 5.
---------------------------------------------------------------------------

    FINRA also clarified, in response the commenter's request for
guidance regarding the reporting of certain bonds with sinking funds,
that ``FINRA is engaged in an ongoing review of issues raised by the
MPP migration, and will address this and other specific trade reporting
questions prior to the MPP migration in its usual and periodic
communications with members.'' \27\
---------------------------------------------------------------------------

    \27\ See id.
---------------------------------------------------------------------------

    Another commenter raised issues not germane to the proposed rule
change and to which FINRA did not respond.\28\
---------------------------------------------------------------------------

    \28\ See Shatto Letter.
---------------------------------------------------------------------------

IV. Discussion

    After carefully considering the proposal, the comments submitted,
and FINRA's response to those comments, the Commission finds that the
proposed rule change is consistent with the requirements of the Act and
the rules and regulations thereunder applicable to a national
securities association.\29\ In particular, the Commission finds that
the proposed rule change is consistent with Section 15A(b)(6) of the
Act,\30\ which requires, among other things, that FINRA rules 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.
---------------------------------------------------------------------------

    \29\ In approving this proposal, the Commission has considered
the proposed rule's impact on efficiency, competition, and capital
formation. See 15 U.S.C. 78c(f).
    \30\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

    Transactions in TRACE-Eligible Securities that are Asset-Backed
Securities already are processed on the MPP. FINRA now proposes to
migrate all other TRACE-Eligible Securities to the MPP and consolidate
the reporting of TRACE-Eligible Securities on a single technology
platform using common reporting formats. The Commission believes that
this change will support more timely and accurate reporting of all
transactions in TRACE-Eligible Securities and enhance FINRA's ability
to surveil the debt markets for the protection of investors and in
furtherance of the public interest. The

Commission notes that the proposed changes being approved today are
substantially similar to requirements that already apply to
transactions in Asset-Backed Securities that previously have been
approved by the Commission.\31\ The Commission believes, therefore,
that it is reasonable and consistent with the Act for FINRA to modify
the TRACE reporting rules to facilitate MPP migration for corporate
bond and Agency Debt Securities in the manner set forth in the
proposal.
---------------------------------------------------------------------------

    \31\ See Securities Exchange Act Release No. 61566 (February 22,
2010), 75 FR 9262 (March 1, 2010) (order approving File No. SR-
FINRA-2009-065); Securities Exchange Act Release No. 64364 (April
28, 2011), 76 FR 25385 (May 4, 2011) (order approving File No. SR-
FINRA-2011-012).
---------------------------------------------------------------------------

    The Commission does not believe that the commenters raise any issue
that would preclude approval of the proposal. The Commission
acknowledges the potential for firms covered by these new reporting
requirements to incur certain compliance burdens and notes one
commenter's objection to FINRA's suggested implementation date of
February 6, 2012. The Commission notes that FINRA has indicated a
willingness to continue to provide guidance and assistance to market
participants throughout the implementation process, including providing
ample testing opportunities.

V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\32\ that the proposed rule change (SR-FINRA-2011-053) be, and
hereby is, approved.
---------------------------------------------------------------------------

    \32\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
---------------------------------------------------------------------------
pursuant to delegated authority.\33\

    \33\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2011-30284 Filed 11-23-11; 8:45 am]
BILLING CODE 8011-01-P


                          Notes from Meeting with CVS

Attended by:
CVS Staff:		Pat Perry

Troutman Sanders:	Greg Blount and John Johnson

EPA Staff:	Kristin Fitzgerald

Date:			September 18, 2013

EPA met with a representative of CVS and their outside legal counsel from Troutman Sanders.

CVS inquired about the progress of the pharmaceuticals proposed rule.  They reiterated the following high priority concerns that they hope the proposed rule will address:

      1.  Nicotine gum, patches and lozenges causing their retail stores to notify and operate as LQGs (approximately 3300 stores), stores that otherwise would be CESQGs

      2. National consistency among the state programs for pharmaceutical management; even recognizing that the only way to achieve national consistency is to propose a rule that is considered more stringent rule than current regulations.

CVS also inquired about the status of the Retail NODA.  They indicated that they have already prepared data that they are looking forward to submitting the data when the NODA is published.  They indicated that their peer institutions also have prepared data to submit in response to the NODA.