[Federal Register Volume 87, Number 224 (Tuesday, November 22, 2022)]
[Notices]
[Page 71398]
[FR Doc No: 2022-25322]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2008-0028]

Petition for Extension of Waiver of Compliance

    Under part 211 of title 49 Code of Federal Regulations (CFR), this
document provides the public notice that on October 31, 2022, Riverport
Railroad, LLC (RVPR) petitioned the Federal Railroad Administration
(FRA) for an extension of a waiver of compliance from certain
provisions of the Federal railroad safety regulations contained at 49
CFR part 223 (Safety Glazing Standards--Locomotives, Passenger Cars and
Cabooses). The relevant FRA Docket Number is FRA-2008-0028.
    Specifically, RVPR requests relief from Sec.  223.11(a),
Requirements for Existing Locomotives, for one locomotive, RVPR 4029,
for operations not exceeding 10 miles per hour over a section of track
on the former Department of Defense Savanna Army Depot. The
installation is located in rural northwestern Illinois, with 80 percent
of the adjoining land owned by RVPR and partially under private
ownership. In support of its petition, RVPR states that the subject
trackage is enclosed and there are no overhead structures or bridges
from which objects could be thrown.
    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 party
desires 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 https://www.regulations.gov. Follow the online instructions for submitting
comments.
    Communications received by January 23, 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), the U.S.
Department of Transportation (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. 2022-25322 Filed 11-21-22; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 77, Number 239 (Wednesday, December 12, 2012)]
[Rules and Regulations]
[Pages 73902-73906]
[FR Doc No: 2012-29708]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0496; Directorate Identifier 2011-NM-263-AD;
Amendment 39-17283; AD 2012-25-02]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc. Airplanes

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

ACTION: Final rule.

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SUMMARY: We are superseding an existing airworthiness directive (AD)
for certain Bombardier, Inc. Model CL-600-2B19 (Regional Jet Series 100
& 440) airplanes. That AD currently requires revising the airworthiness
limitations section (AWL) of the Instructions for Continued
Airworthiness (ICA) of the Canadair Regional Jet Maintenance
Requirements Manual (MRM) by incorporating new procedures for
repetitive detailed and special detailed inspections for cracking of
the aft pressure bulkhead. This new AD requires revising the
maintenance program to incorporate a revised task specified in a
certain temporary revision, which requires an improved non-destructive
inspection procedure; and adds airplanes to the applicability. This AD
was prompted by multiple reports of cracks on the forward face of the
rear pressure bulkhead (RPB) web. We are issuing this AD to detect and
correct cracking in the RPB, which could result in reduced structural
integrity and rapid decompression of the airplane.

DATES: This AD becomes effective January 16, 2013.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of January 16,
2013.
    The Director of the Federal Register approved the incorporation by
reference of a certain other publication listed in this AD as of
November 29, 2005 (70 FR 69073, November 14, 2005).

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: Jeffrey Zimmer, Aerospace Engineer,
Airframe and Mechanical Systems Branch, ANE-171, FAA, New York Aircraft
Certification Office, 1600 Stewart Avenue, Suite 410, Westbury, New
York 11590; telephone<PHONE_NUMBER>; 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 June 1, 2012 (77 FR
32439), and proposed to supersede AD 2005-23-01, Amendment 39-14359 (70
FR 69073, November 14, 2005). That NPRM proposed to correct an unsafe
condition for the specified products. Transport Canada Civil Aviation
(TCCA) Mandatory Continuing Airworthiness Information (MCAI) states:

    Cracks on the forward face of the Rear Pressure Bulkhead (RPB)
web have been discovered on three CL-600-2B19 aeroplanes in-service.
This indicates that the existing inspection requirements of
Airworthiness Limitation (AWL) task 53-61-153 mandated by [TCCA] AD
CF-2005-13R1 are not adequate. Failure of the RPB could result in
rapid decompression of the aeroplane.
    A Temporary Revision (TR) has been made to Part 2 of the
Maintenance Requirements Manual (MRM) to revise the existing AWL
task by introducing an improved Non-Destructive Inspection (NDI)
procedure to ensure that fatigue cracking of the RPB is detected and
corrected.
    This [TCCA] directive mandates the incorporation of a new NDI
procedure for AWL task number 53-61-153.

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 have considered the comments received.

Request To Remove Certain Paragraphs of the NPRM (77 FR 32439, June 1,
2012)

    Air Wisconsin requested that we remove paragraphs (g) and (h) from
the NPRM (77 FR 32439, June 1, 2012) because paragraph (i) of the NPRM
supersedes those paragraphs. Air Wisconsin stated several examples of
how paragraphs (g) and (h) are superseded by paragraph (i) of the NPRM.
    We disagree with the commenter's request to remove paragraphs (g)
and (h) from this final rule. We find it necessary to restate those
paragraphs in this final rule to ensure the existing inspections are
done until the required maintenance program revision specified in
paragraph (i) of this AD is accomplished. In addition, if an airplane
is imported into the United States, it is necessary to accomplish the
requirements of paragraph (g) of this AD before the airplane may be
operated in this country.
    However, we find that clarification of paragraph (i) of this AD is
necessary. Once the maintenance program revision is accomplished, the
restated requirements of paragraph (g) of this AD are terminated.
Therefore, we have revised the last sentence of paragraph (i) of this
AD to specify that doing the revision required by paragraph (i) of this
AD terminates the requirements of paragraph (g) of this AD.
    In addition, we have retained paragraph (h) in this final rule
because it is necessary to allow Canadair Regional Jet Temporary
Revision TR 2B-2109, dated October 13, 2005, to be removed from the
maintenance requirements manual once a general revision is done.
Further, we have determined that it is necessary to add a paragraph
similar to paragraph (h) of this AD to allow removal of the temporary
revision specified in paragraph (i) of this AD. Accordingly, we have
revised this final rule to add new paragraph (k) to this AD to specify
that information. Subsequent paragraphs have been reidentified.

Request To Revise Serial Numbers

    Air Wisconsin requested that we correct the serial numbers in
paragraph (c) or (g) of the NPRM (77 FR 32439, June 1, 2012) for
consistency.
    We disagree with the request. The serial numbers specified in
paragraph (g) of this AD are only those that were part of the
applicability of AD 2005-23-01, Amendment 39-14359 (70 FR 69073,
November 14, 2005). Paragraph (c) of this AD lists all serial numbers
that are affected by this new AD.

Requests To Clarify Compliance Time

    In regard to paragraph (i)(2) of the NPRM (77 FR 32439, June 1,
2012), Air Wisconsin requested we clarify that, if the last inspection
performed met the requirements of AWL 53-61-153 specified in Bombardier
TR 2B-2187, dated June 22, 2011, to Appendix B--Airworthiness
Limitations, of Part 2 of the Bombardier CL-600-2B19 MRM, the next
inspection cycle as specified in that TR is acceptable provided that
interval is not greater than that specified in Bombardier TR 2B-2187,
dated June 22, 2011.
    In addition, Comair requested that we provide credit for paragraph
(i) of the NPRM (77 FR 32439, June 1, 2012) for operators that
performed previous inspections using the special detailed inspection
option specified in AWL 53-61-153 of the Canadair Regional Jet TR 2B-
2109, dated October 13, 2005, to Appendix B, ``Airworthiness
Limitations,'' of Part 2 of the Canadair Regional Jet MRM. Comair
stated that it requested this credit so that operators would not be
subject to the initial compliance time specified in paragraph (i)(1) or
(i)(2) of the NPRM (77 FR 32439, June 1, 2012).
    We agree to clarify the inspection compliance time. We agree that,
if the last special detailed inspection (not the detailed visual
inspection) performed met the requirements of AWL 53-61-153 specified
in Bombardier TR 2B-2187, dated June 22, 2011; or Canadair Regional Jet
TR 2B-2109, dated October

13, 2005; to Appendix B--Airworthiness Limitations, of Part 2 of the
Bombardier CL-600-2B19 MRM; the next inspection should be at the next
compliance time specified in AWL 53-61-153 of Bombardier TR 2B-2187,
dated June 22, 2011 (i.e., within 4,360 landings since the last
inspection). We have changed paragraph (i) of this AD to state that for
airplanes that have already complied with AWL 53-61-153 of Bombardier
TR 2B-2187, dated June 22, 2011, or the special detailed inspection
option specified in Canadair Regional Jet TR 2B-2109, dated October 13,
2005, the initial compliance time for AWL 53-61-153 is within 4,360
flight cycles after accomplishing the most recent special detailed
inspection, or within 1,500 flight cycles after accomplishing the most
recent detailed inspection as specified in AWL 53-61-153 of Canadair
Regional Jet TR 2B-2109, dated October 13, 2005, whichever occurs
later.

Request To Approve Previous Alternative Methods of Compliance (AMOC)

    Air Wisconsin requested that a statement be added to paragraph (k)
of the NPRM (77 FR 32439, June 1, 2012) approving use of existing AMOCs
that were approved previously in accordance with AD 2005-23-01,
Amendment 39-14359 (70 FR 69073, November 14, 2005).
    We agree to allow existing AMOCs approved in accordance with AD
2005-23-01, Amendment 39-14359 (70 FR 69073, November 14, 2005), as
AMOCs for the corresponding requirements of paragraphs (g) and (h) of
this AD only. We have revised paragraph (l)(1) of this AD (referred to
as paragraph (k)(1) of the NPRM (77 FR 32439, June 1, 2012))
accordingly.

Request To Remove Reference to a Certain TR

    Air Wisconsin requested that we remove the reference to Canadair
Regional Jet TR 2B-2109, dated October 13, 2005, to Appendix B--
Airworthiness Limitations, of Part 2 of the Bombardier CL-600-2B19 MRM
from paragraph (j) of the NPRM (77 FR 32439, June 1, 2012). Air
Wisconsin noted that Canadair Regional Jet TR 2B-2109, dated October
13, 2005, conflicts with Bombardier TR 2B-2187, dated June 22, 2011,
and stated that Bombardier TR 2B-2187, dated June 22, 2011,
specifically removed the ``visual inspection'' option that was in
Canadair Regional Jet TR 2B-2109, dated October 13, 2005.
    We agree with the request for the reasons stated by the commenter.
We have removed the reference to Canadair Regional Jet TR 2B-2109,
dated October 13, 2005, to Appendix B--Airworthiness Limitations, of
Part 2 of the Bombardier CL-600-2B19 MRM, from paragraph (j) of this
AD. Paragraph (i) of this AD requires that the maintenance program be
revised to incorporate Bombardier TR 2B-2187, dated June 22, 2011.
Paragraph (i) of this AD also specifies that once the revision is done,
the requirements of paragraph (g) of this AD are terminated (paragraph
(g) of the AD incorporated Bombardier TR 2B-2109, dated October 13,
2005).

Conclusion

    We reviewed the available data, including the comments received,
and determined that air safety and the public interest require adopting
the AD with the changes described previously and minor editorial
changes. We have determined that these changes:
     Are consistent with the intent that was proposed in the
NPRM (77 FR 32439, June 1, 2012) for correcting the unsafe condition;
and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (77 FR 32439, June 1, 2012).

Costs of Compliance

    We estimate that this AD will affect about 586 products of U.S.
registry.
    The actions that are required by AD 2005-23-01, Amendment 39-14359
(70 FR 69073, November 14, 2005), and retained in this AD take about 2
work-hours per product, at an average labor rate of $85 per work hour.
Based on these figures, the estimated cost of the currently required
actions is $170 per product.
    We estimate that it will take about 1 work-hour per product to
comply with the new basic requirements of this AD. The average labor
rate is $85 per work-hour. Based on these figures, we estimate the cost
of this AD to the U.S. operators to be $49,810, or $85 per product.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    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 (77 FR 32439, June 1, 2012),
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

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing airworthiness directive (AD)
2005-23-01, Amendment 39-14359 (70 FR 69073, November 14, 2005), and
adding the following new AD:

2012-25-02 Bombardier, Inc.: Amendment 39-17283. Docket No. FAA-
2012-0496; Directorate Identifier 2011-NM-263-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective January 16,
2013.

(b) Affected ADs

    This AD supersedes AD 2005-23-01, Amendment 39-14359 (70 FR
69073, November 14, 2005).

(c) Applicability

    (1) This AD applies to Bombardier, Inc. Model CL-600-2B19
(Regional Jet Series 100 & 440) airplanes, certificated in any
category, serial numbers 7003 and subsequent.
    (2) This AD requires revisions to certain operator maintenance
documents to include new inspections. Compliance with these
inspections is required by 14 CFR 91.403(c). For airplanes that have
been previously modified, altered, or repaired in the areas
addressed by these inspections, the operator may not be able to
accomplish the inspections described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must
request approval for an alternative method of compliance according
to paragraph (l)(1) of this AD. The request should include a
description of changes to the required inspections that will ensure
the continued damage tolerance of the affected structure. The FAA
has provided guidance for this determination in FAA Advisory
Circular (AC) 25.1529-1A, dated November 20, 2007 (http://
rgl.faa.gov/Regulatory--and--Guidance--Library/
rgAdvisoryCircular.nsf/list/AC%2025.1529-1A/$FILE/AC%2025.1529-
1A.pdf).

(d) Subject

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

(e) Reason

    This AD was prompted by multiple reports of cracks on the
forward face of the rear pressure bulkhead (RPB) web. We are issuing
this AD to detect and correct cracking in the RPB, which could
result in reduced structural integrity and rapid decompression of
the airplane.

(f) Compliance

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

(g) Retained Revision to the Airworthiness Limitations (AWL) Section

    This paragraph restates the requirements of paragraph (f) of AD
2005-23-01, Amendment 39-14359 (70 FR 69073, November 14, 2005). For
airplanes having serial numbers 7003 through 8025 inclusive, 8030,
and 8034: Within 30 days after November 29, 2005 (the effective date
of AD 2005-23-01), revise the AWL section of the Instructions for
Continued Airworthiness of the Canadair Regional Jet Maintenance
Requirements Manual (MRM), Part 2, Appendix B, ``Airworthiness
Limitations,'' by incorporating the information specified in AWL 53-
61-153 of the Canadair Regional Jet Temporary Revision (TR) 2B-2109,
dated October 13, 2005, into the AWL section. Perform the applicable
detailed and special detailed inspections for cracking of the aft
pressure bulkhead, as specified in that TR, at the applicable
compliance time specified in table 1 to paragraph (g) of this AD.
Repeat the detailed inspection thereafter at intervals not to exceed
1,085 flight cycles, and repeat the special detailed inspection
thereafter at intervals not to exceed 4,360 flight cycles, in
accordance with the procedures specified in AWL 53-61-153, as
introduced by Canadair Regional Jet TR 2B-2109, dated October 13,
2005, to Appendix B, ``Airworthiness Limitations, of Part 2 of the
Canadair Regional Jet MRM. Accomplishing the revision required by
paragraph (i) of this AD terminates the requirements of this
paragraph.

    Table 1 to Paragraph (g) of This AD--Compliance Times for Initial
                               Inspections
------------------------------------------------------------------------
 As of November 29, 2005 (the effective
  date of AD 2005-23-01, Amendment 39-
    14359 (70 FR 69073, November 14,       Inspect before the airplane
   2005)): If the total flight cycles             accumulates--
   accumulated on the airplane are--
------------------------------------------------------------------------
8,000 or fewer.........................  12,000 total flight cycles.
More than 8,000 but fewer than 12,000..  15,000 total flight cycles or
                                          within 4,000 flight cycles
                                          after November 29, 2005 (the
                                          effective date of AD 2005-23-
                                          01, Amendment 39-14359 (70 FR
                                          69073, November 14, 2005)),
                                          whichever is first.
12,000 or more but fewer than 15,000...  17,000 total flight cycles or
                                          within 3,000 flight cycles
                                          after November 29, 2005 (the
                                          effective date of AD 2005-23-
                                          01 Amendment 39-14359 (70 FR
                                          69073, November 14, 2005)),
                                          whichever is first.
15,000 or more but fewer than 17,000...  18,500 total flight cycles or
                                          within 2,000 flight cycles
                                          after November 29, 2005 (the
                                          effective date of AD 2005-23-
                                          01 Amendment 39-14359 (70 FR
                                          69073, November 14, 2005)),
                                          whichever is first.
17,000 or more but fewer than 18,500...  19,500 total flight cycles or
                                          within 1,500 flight cycles
                                          after November 29, 2005 (the
                                          effective date of AD 2005-23-
                                          01, Amendment 39-14359 (70 FR
                                          69073, November 14, 2005)),
                                          whichever is first.
18,500 or more but fewer than 19,500...  20,000 total flight cycles or
                                          within 1,000 flight cycles
                                          after November 29, 2005 (the
                                          effective date of AD 2005-23-
                                          01, Amendment 39-14359 (70 FR
                                          69073, November 14, 2005)),
                                          whichever is first.
19,500 or more.........................  500 flight cycles after
                                          November 29, 2005 (the
                                          effective date of AD 2005-23-
                                          01, Amendment 39-14359 (70 FR
                                          69073, November 14, 2005)).
------------------------------------------------------------------------

(h) Retained General Revision of the MRM

    This paragraph restates the requirements of paragraph (g) of AD
2005-23-01, Amendment 39-14359 (70 FR 69073, November 14, 2005). For
airplanes having serial numbers 7003 through 8025 inclusive, 8030,
and 8034: When the information in AWL 53-61-153 of the Canadair
Regional Jet TR 2B-2109, dated October 13, 2005, to Appendix B,
``Airworthiness Limitations,'' of Part 2 of the Canadair Regional
Jet MRM, is included in the general revisions of the MRM, the
general revisions may be inserted into the AWL section of the
Instructions for Continued Airworthiness, and this information may
be removed from the MRM.

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

    Within 60 days after the effective date of this AD: Revise the
maintenance program by incorporating the revised inspection
requirements specified in AWL 53-61-153 of Bombardier TR 2B-2187,
dated June 22, 2011, to Appendix B--Airworthiness Limitations, of
Part 2 of the Bombardier CL-600-2B19 MRM. The initial compliance
times for the task are at the applicable time specified in paragraph
(i)(1) or (i)(2) of this AD. Doing the revision required by
paragraph (i) of this AD terminates the requirements of paragraph
(g) of this AD.

    (1) For airplanes on which the special detailed inspection
specified in AWL 53-61-153 of Bombardier TR 2B-2187, dated June 22,
2011; or Canadair Regional Jet TR 2B-2109, dated October 13, 2005;
has not been done as of the effective date of this AD: The initial
compliance time for AWL 53-61-153 is at the applicable time
specified in paragraph (i)(1)(i) or (i)(1)(ii) of this AD.
    (i) For airplanes that have accumulated 10,500 total flight
cycles or less as of the effective date of this AD: Before the
accumulation of 12,000 total flight cycles.
    (ii) For airplanes that have accumulated more than 10,500 total
flight cycles as of the effective date of this AD: Within 1,500
flight cycles after the effective date of this AD.
    (2) For airplanes on which the special detailed inspection
specified in AWL 53-61-153 of Bombardier TR 2B-2187, dated June 22,
2011; or Canadair Regional Jet TR 2B-2109, dated October 13, 2005;
has been done as of the effective date of this AD: The initial
compliance time for AWL 53-61-153 is within 4,360 flight cycles
after accomplishing the most recent special detailed inspection, or
within 1,500 flight cycles after accomplishing the most recent
detailed inspection as specified in AWL 53-61-153 of Canadair
Regional Jet TR 2B-2109, dated October 13, 2005, whichever occurs
later.

(j) No Alternative Actions or Intervals

    After accomplishing the revisions required by paragraph (i) of
this AD, no alternative actions (e.g., inspections) or intervals may
be used other than those specified in Bombardier TR 2B-2187, dated
June 22, 2011, to Appendix B--Airworthiness Limitations, of Part 2
of the Bombardier CL-600-2B19 MRM, unless the actions and intervals
are approved as an AMOC in accordance with the procedures specified
in paragraph (l)(1) of this AD.

(k) New Action of This AD: General Revision of the MRM

    The maintenance program revision required by paragraph (i) of
this AD may be done by inserting a copy of Bombardier TR 2B-2187,
dated June 22, 2011, into Appendix B--Airworthiness Limitations, of
Part 2 of the Bombardier CL-600-2B19 MRM. When this TR has been
included in general revisions of the MRM, the general revisions may
be inserted in the MRM, provided the relevant information in the
general revision is identical to that in this TR.

(l) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office (ACO), ANE-170, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the ACO, send it to ATTN: Program
Manager, Continuing Operational Safety, FAA, New York ACO, 1600
Stewart Avenue Suite 410, Westbury, New York 11590; telephone (516)
228-7300; fax<PHONE_NUMBER>. Before using any approved AMOC, notify
your appropriate principal inspector, or lacking a principal
inspector, the manager of the local flight standards district
office/certificate holding district office. The AMOC approval letter
must specifically reference this AD. AMOCs approved previously in
accordance with AD 2005-23-01, Amendment 39-14359 (70 FR 69073,
November 14, 2005), are approved as AMOCs with the corresponding
requirements of paragraphs (g) and (h) of this AD only.
    (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.

(m) 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.
    (3) The following service information was approved for IBR on
January 16, 2013.
    (i) Bombardier TR 2B-2187, dated June 22, 2011, to Appendix B--
Airworthiness Limitations, of Part 2 of the Bombardier CL-600-2B19
MRM.
    (ii) Reserved.
    (4) The following service information was approved for IBR on
November 29, 2005 (70 FR 69073, November 14, 2005).
    (i) Canadair Regional Jet Temporary Revision 2B-2109, dated
October 13, 2005, to the Canadair Regional Jet Maintenance
Requirements Manual, Part 2, Appendix B, ``Airworthiness
Limitations.''
    (ii) Reserved.
    (5) For service information identified in this AD, contact
Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval,
Qu[eacute]bec H4S 1Y9, Canada; telephone<PHONE_NUMBER>; fax 514-855-
7401; email<EMAIL_ADDRESS>Internet http://www.bombardier.com.
    (6) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA.
For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.
    (7) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on November 30, 2012.
Kalene C. Yanamura,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-29708 Filed 12-11-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 73 (Monday, April 16, 2018)]
[Notices]
[Pages 16420-16421]
[FR Doc No: 2018-07786]

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

SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

Extension:
    Regulation G, SEC File No. 270-518, OMB Control No. 3235-0576

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Regulation G (17 CFR 244.100-244.102) under the Securities Exchange
Act of 1934 (the ``Exchange Act'') (15 U.S.C. 78a et seq.) requires
publicly reporting companies that disclose or releases financial
information in a manner that is calculated or presented other than in
accordance with generally accepted accounting principles (``GAAP'') to
provide a reconciliation of the non-GAAP financial information to the
most directly comparable GAAP financial measure. Regulation G
implemented the requirements of Section 401 of the Sarbanes-Oxley Act
of 2002 (15 U.S.C. 7261). We estimate that approximately 14,000 public
companies must comply with Regulation G approximately six times a year
for a total of 84,000 responses annually. We estimated that it takes
approximately 0.5 hours per response (84,000 x 0.5 hours) for a total
reporting burden of 42,000 hours annually.
    Written comments are invited on: (a) Whether this collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information will have practical
utility; (b) the accuracy of the agency's estimate of the burden
imposed by the collections of information; (c) ways to enhance the
quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.

    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    Please direct your written comments to Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE, Washington, DC 20549; or send an email
to: [email protected].

    Dated: April 9, 2018.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-07786 Filed 4-13-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 13 (Friday, January 19, 2018)]
[Notices]
[Pages 2790-2792]
[FR Doc No: 2018-00915]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1309]

Compounded Drug Products That Are Essentially Copies of a
Commercially Available Drug Product Under Section 503A of the Federal
Food, Drug, and Cosmetic Act; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``Compounded Drug
Products That Are Essentially Copies of a Commercially Available Drug
Product Under Section 503A of the Federal Food, Drug, and Cosmetic
Act.'' One of the conditions to qualify for exemptions under section
503A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), is
that a drug product must be compounded by a licensed pharmacist or
physician who does not compound regularly or in inordinate amounts any
drug products that are essentially copies of a commercially available
drug product. This guidance sets forth FDA policies regarding this
provision of section 503A, including the terms ``commercially
available,'' ``essentially a copy of a commercially available drug

product,'' and ``regularly or in inordinate amounts.''

DATES: The announcement of the guidance is published in the Federal
Register on January 19, 2018.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-1309 for ``Compounded Drug Products That Are Essentially
Copies of a Commercially Available Drug Product Under Section 503A of
the Federal Food, Drug, and Cosmetic Act.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Sara Rothman, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20993, 301-796-
3110.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry
entitled ``Compounded Drug Products That Are Essentially Copies of a
Commercially Available Drug Product Under Section 503A of the Federal
Food, Drug, and Cosmetic Act.'' Section 503A (21 U.S.C. 353a), added to
the FD&C Act by the Food and Drug Administration Modernization Act of
1997, describes the conditions that must be satisfied for human drug
products compounded by a licensed pharmacist in a State-licensed
pharmacy or Federal facility, or by a licensed physician, to be exempt
from the following three sections of the FD&C Act:
     Section 501(a)(2)(B) (21 U.S.C. 351 (a)(2)(B)) (concerning
current good manufacturing practice requirements);
     Section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the
labeling of drugs with adequate directions for use); and
     Section 505 (21 U.S.C. 355) (concerning the approval of
drugs under new drug applications (NDAs) or abbreviated new drug
applications (ANDAs)).
    One of the conditions that must be met for a compounded drug
product to qualify for the exemptions under section 503A of the FD&C
Act is that it must be compounded by a licensed pharmacist or a
licensed physician that does not compound regularly or in inordinate
amounts (as defined by the Secretary of Health and Human Services) any
drug products that are essentially copies of a commercially available
drug product (section 503A(b)(1)(D)).
    The statute further states that the term ``essentially a copy of a
commercially available drug product'' does not include a drug product
in which there is a change, made for an identified individual patient,
which produces for that patient a significant difference, as determined
by the prescribing practitioner, between the compounded drug and the
comparable commercially available drug product (section 503A(b)(2) of
the FD&C Act).
    This guidance sets forth FDA's policies concerning the
``essentially a copy'' provision under section 503A of the FD&C Act,
including the terms ``commercially available,'' ``essentially a copy of
a commercially available drug product,'' and ``regularly or in
inordinate amounts.''

    In the Federal Register of July 11, 2016 (81 FR 44881), FDA issued
a notice announcing the availability of the draft version of this
guidance. The comment period on the draft guidance ended on October 11,
2016. FDA received approximately 88 comments on the draft guidance. In
response to received comments or on its own initiative, FDA made
several changes. For example, in response to requests in comments for
direction on records retention, FDA added a recommendation that
compounders maintain the records described in the guidance for a period
of at least 3 years. In addition, to address questions raised in
comments, FDA clarified that the policies in this guidance apply to a
compounded drug product without regard to the source(s) of the active
pharmaceutical ingredient (API) in that product, for example, the
policies would apply regardless of whether the compounder used an API
that was purchased as an isolate, or if the compounder modified a
finished drug product containing an API.
    FDA received comments on the draft guidance from hospital
organizations regarding the potential implications of the proposed
policies in the draft guidance for the preparation of compounded drugs
used in in-patient settings. The final guidance notes that FDA is
considering the applicability of the policies described in this
guidance to hospitals and health systems. We recognize that this issue
is of interest to many stakeholders and will convey our further
thinking on the applicability of these policies to hospitals and health
systems publicly with an opportunity for comment.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). This guidance represents the
current thinking of FDA on ``Compounded Drug Products That Are
Essentially Copies of a Commercially Available Drug Product Under
Section 503A of the Federal Food, Drug, and Cosmetic Act.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance contains collections of information that are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520). Under the
PRA, Federal Agencies must obtain approval from OMB for each collection
of information they conduct or sponsor. ``Collection of information''
is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3 and includes Agency
requests or requirements that members of the public submit reports,
keep records, or provide information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in the Federal Register concerning
each proposed collection of information before submitting the
collection to OMB for approval. To comply with this requirement, in the
Federal Register of July 11, 2016, we gave interested persons 60 days
to comment on the information collection provisions in the draft
guidance (81 FR 44881).
    The information collection provisions in this guidance have been
submitted to OMB for review as required by section 3507(d) of the PRA.
These provisions are not in effect until they display a currently valid
OMB control number. FDA will publish a notice in the Federal Register
announcing OMB's decision regarding the information collection
provisions in this guidance.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: January 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00915 Filed 1-18-18; 8:45 am]
 BILLING CODE 4164-01-P


E C/R Incorporated	          Providing Environmental Technical Support
Since 1989

MEMORANDUM  SEQ CHAPTER \h \r 1

TO:		Melanie King, EPA OAQPS/SPPD/ESG

FROM:	Tanya Parise, EC/R, Inc.

SUBJECT:	Summary of the September 3, 2010 Teleconference with Exterran
Regarding the Proposed Amendments to the NSPS for Stationary Engines

INTRODUCTION

Exterran requested this teleconference with EPA to discuss the proposed
amendments to the new source performance standards (NSPS) for stationary
engines, specifically issues related to the definition of reconstruction
and the date of manufacture.  The proposed NSPS amendments were
published in the Federal Register on June 8, 2010 (75 FR 32612).

ATTENDEES

Melanie King, EPA	Gerald Meinecke, Exterran

Michael Horowitz, EPA	Mike Wasson, Exterran

Alan Stout, EPA	Bill Bowes, Exterran

Tanya Parise, EC/R Inc.	James Harrison, Exterran

Jeff Holmstead, Bracewell & Giuliani	Kyle Jantzen, Exterran

Rebecca Rentz, Bracewell & Giuliani

SUMMARY OF TELECONFERENCE

	Exterran indicated that it had concerns with certain provisions in the
proposed amendments to NSPS for stationary engines.  Exterran’s main
issue with the proposed amendments was the addition of the definitions
of “reconstruct” and “date of manufacture.”

In terms of the reconstruction provisions, Exterran noted that the
proposal represents a departure from other 40 CFR part 60 regulations
and expressed particular concern with triggering NSPS with the 75
percent capital cost threshold.  Exterran asked what EPA’s intentions
are with the proposed amendments.  EPA indicated that the proposed
amendments are not entirely different from other regulations; in fact,
something similar is being done with reconstruction of combustion
turbines.  EPA indicated that the purpose of the proposed amendments was
to minimize attempts to circumvent the requirements where an engine
should be regulated as a new engine.  Also, EPA indicated that the
language with respect to reconstructing, rebuilding, or refurbishing an
engine previously made it seem as if only owners and operators would be
subject to the requirements.  EPA intended to clarify that with the
proposed amended language and to generally minimize relying on the
language in the General Provisions by being more specific in the
proposed amendments.  EPA indicated that it is open to ideas from
industry and would like information on how the proposed amendments could
cause problems for owners and operators.

In Exterran’s opinion, EPA needs to look at the additional costs
associated with reconstructing an engine and not only consider the costs
directly associated with the engine itself.  For example, engineering,
installation and other equipment costs need to be included in
determining a “comparable new facility.”  According to Exterran,
stationary engines are regularly updated and during an overhaul the
engine is unbolted from the support system and dropped back into place
after the necessary components (exhaust system, cooling system, inlet
air system, etc.) have been inspected and replaced, as necessary.  To
find a new engine to fit in the same location having the same design,
would be difficult, e.g., the mounting arrangement could change, and
according to Exterran, a new engine could not just be “dropped-in”
with the existing auxiliary system.  Such replacement would at least
have to be re-evaluated and Exterran asked that EPA look at and allow
the use of other costs as well like the install and engineering costs
that would occur during such a determination.  EPA indicated that it
would consider Exterran’s comments and discuss this issue with the
Office of Enforcement and Compliance Assurance.  EPA indicated that it
was not intending on changing the definition of “fixed capital
costs” in 40 CFR 60.15(c).

Exterran indicated that the nitrogen oxides (NOx) emissions from
4-stroke lean burn engines (4SLB) are less than 3 grams per
horsepower-hour (g/HP-hr).  According to Exterran, 4SLB engines can
easily meet the first tier of standards in the spark ignited NSPS.
However, Exterran believed that it would not make sense to control 4SLB
engines to 1 g/HP-hr of NOx if these engines received a new date of
manufacture and subsequently would be subject to the second tier of
standards.  In Exterran’s opinion, this would be getting rid of an
efficient engine and this does not seem to be EPA’s intent.  Exterran
recommended that if a source meets the 75 percent reconstruction
criteria, the engine should be subject to the standards applicable to
reconstructed engines, not the standards applicable to new engines.

Where EPA proposed to add the definition of “date of manufacture” to
40 CFR §§60.4219 and 60.4248, Exterran disagrees that the removal of
the crankshaft during reconstruction should a determining factor.
According to Exterran, the crankshaft is removed with every maintenance
event and the removal of this part does not seem to fit with EPA’s
intent.  EPA indicated that it would look at this issue.  Exterran
indicated that it would provide additional and more extensive discussion
and rationale supporting its position in the comments that it intends on
submitting to EPA on the proposed rule amendments.

  PAGE   \* MERGEFORMAT  1


[Federal Register Volume 76, Number 135 (Thursday, July 14, 2011)]
[Notices]
[Pages 41507-41508]
[FR Doc No: 2011-17695]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Obstetrics and Gynecology Devices Panel of the Medical Devices
Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Obstetrics and Gynecology Devices Panel of the
Medical Devices Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on September 8 and 9, 2011,
from 8 a.m. to 6 p.m.
    Location: Holiday Inn, Ballroom, 2 Montgomery Village Ave.,
Gaithersburg, MD 20879.
    Contact Person: Shanika Craig, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm. 1613,<PHONE_NUMBER>, or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area), and follow the prompts to the desired center or
product area. Please call the Information Line for up-to-date
information on this meeting. A notice in the Federal Register about
last minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the Agency's Web site
and call the appropriate advisory committee hot line/phone line to
learn about possible modifications before coming to the meeting.
    Agenda: On September 8 and 9, 2011, the committee will discuss and
make recommendations regarding the safety and effectiveness of
transvaginal surgical mesh used for repair of pelvic organ prolapse.
FDA is convening this meeting to seek expert opinion on the risks and
benefits of these devices in light of adverse events, e.g., vaginal
erosion leading to pelvic pain and dyspareunia, and available
information on clinical benefit. The committee will be asked to provide
scientific and clinical input on the Agency's proposed premarket and
postmarket regulatory strategies for these devices, including

reclassification into Class III (premarket approval), labeling
improvements and postmarket surveillance studies. The committee will
also consider surgical mesh used to treat stress urinary incontinence.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
August 30, 2011. Oral presentations from the public will be scheduled
between approximately 10 a.m. and 11 a.m. on September 8 and 9, 2011.
Those individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
August 22, 2011. Time allotted for each presentation may be limited. If
the number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by August 23, 2011.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact AnnMarie Williams,
Committee Management Staff,<PHONE_NUMBER> at least 7 days in advance of
the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: June 30, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-17695 Filed 7-13-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: June 2, 2009 (Volume 74, Number 104)]
[Notices]
[Page 26407-26408]
[DOCID:fr02jn09-70]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0232]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Interstate Shellfish Dealers Certificate

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
provisions of the Interstate Shellfish Dealers Certificate.

DATES:  Submit written or electronic comments on the collection of
information by August 3, 2009.

ADDRESSES:  Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Jonna Capezzuto, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Interstate Shellfish Dealers Certificate (OMB Control Number 0910-
0021)--Extension

    Under 42 U.S.C. 243, FDA is required to cooperate with and aid
State and local authorities in the enforcement of their health
regulations and is authorized to assist States in the prevention and
suppression of communicable diseases. Under this authority, FDA
participates with State regulatory agencies, some foreign nations, and
the molluscan shellfish industry in the National Shellfish Sanitation
Program (NSSP).
    NSSP is a voluntary, cooperative program to promote the safety of
molluscan shellfish by providing for the classification and patrol of
shellfish growing waters and for the inspection and certification of
shellfish processors. Each participating State and foreign nation
monitors its molluscan shellfish processors and issues certificates for
those that meet the State or foreign shellfish control authority's
criteria. Each participating State and nation provides a certificate of
its certified shellfish processors to FDA on Form FDA 3038,
``Interstate Shellfish Dealer's Certificate.'' FDA uses this
information to publish the ``Interstate Certified Shellfish Shippers
List,'' a monthly comprehensive listing of all molluscan shellfish
processors certified under the cooperative program. If FDA did not
collect the information necessary to compile this list, participating
States would not be able to identify and keep out shellfish processed
by uncertified processors in other States and foreign nations.
Consequently, NSSP would not be able to control the distribution of
uncertified and possibly unsafe shellfish in interstate commerce, and
its effectiveness would be nullified.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                               Annual Frequency     Total Annual        Hours per
              Activity                  FDA Form No.     No. of Respondents      per Response        Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission of Interstate Shellfish               3,038                    40                 57              2,280               0.10               228
 Dealer's Certificate
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA estimates that 40 respondents will submit 2,280 Interstate
Shellfish Dealer's Certificates annually, for a total burden of 228
hours (2,280 submissions x 0.10 hours = 228 hours). This estimate is
based on FDA's experience and the number of certificates received in
the past 3 years.

    Dated: May 27, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-12796 Filed 6-1-09; 8:45 am]

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[Federal Register Volume 80, Number 116 (Wednesday, June 17, 2015)]
[Notices]
[Page 34672]
[FR Doc No: 2015-14879]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-2347]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Food and Cosmetic Export Certificate
Applications Process

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled, ``Food and Cosmetic Export
Certificate Applications Process'' has been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On April 23, 2015, the Agency submitted a
proposed collection of information entitled, ``Food and Cosmetic Export
Certificate Applications Process'' to OMB for review and clearance
under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a
person is not required to respond to, a collection of information
unless it displays a currently valid OMB control number. OMB has now
approved the information collection and has assigned OMB control number
0910-0793. The approval expires on May 31, 2018. A copy of the
supporting statement for this information collection is available on
the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: June 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14879 Filed 6-16-15; 8:45 am]
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[Federal Register Volume 79, Number 128 (Thursday, July 3, 2014)]
[Proposed Rules]
[Pages 37965-37967]
[FR Doc No: 2014-15620]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0363; Directorate Identifier 2014-NE-08-AD]
RIN 2120-AA64

Airworthiness Directives; Rolls-Royce plc Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
Rolls-Royce plc (RR) RB211 Trent 768-60, 772-60, and 772B-60 turbofan
engines. This proposed AD was prompted by fuel leaks caused by damage
to the fan case low-pressure (LP) fuel tube. This proposed AD would
require inspection of the fan case LP fuel tubes and associated clips
and the fuel oil heat exchanger (FOHE) mounts and associated hardware.
We are proposing this AD to prevent failure of the fan case LP fuel
tube, which could lead to an in-flight shutdown of one or more engines
due to fuel starvation, loss of thrust control, and damage to the
airplane.

DATES: We must receive comments on this proposed AD by September 2,
2014.

ADDRESSES: You may send comments by any of the following methods:
     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>.
    For service information identified in this proposed AD, contact
Rolls-Royce plc, Corporate Communications, P.O. Box 31, Derby, England,
DE248BJ; phone: 011-44-1332-242424; fax: 011-44-1332-249936; email:
http://www.rolls-royce.com/contact/civil_team.jsp; Web site: https://www.aeromanager.com. 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>.

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-2014-
0363; 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 mandatory continuing airworthiness
information (MCAI), the regulatory evaluation, any comments received,
and other information. The address for the Docket Office (phone: 800-
647-5527) is in the ADDRESSES section. Comments will be available in
the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Wego Wang, Aerospace Engineer, Engine
Certification Office, FAA, Engine & Propeller Directorate, 12 New
England Executive Park, Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:
781-238-7199; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2014-0363;
Directorate Identifier 2014-NE-08-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact
with FAA personnel concerning this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
AD 2014-0089, dated April 15, 2014 (referred to hereinafter as ``the
MCAI''), to correct an unsafe condition for the specified products. The
MCAI states:

    Fuel leaks from the engine have occurred in-service due to
damage to sections of the fan case low-pressure (LP) fuel tube which
runs between the fuel oil heat exchanger (FOHE) and the high
pressure fuel pump. Frettage damage between the securing clips and
the tube outer surface has been caused by excessive movement within
the system that resulted from deterioration of the FOHE mounting
hardware. The thinning of the tube wall causes the tube to fracture
and fuel loss to occur.
    This condition, if not detected and corrected, could lead to a
critical fuel imbalance or in-flight fuel starvation, possibly
resulting engine in-flight shut-down and, consequently, reduced
control of the aeroplane.
    For the reasons described above, this AD requires repetitive on-
wing and in-shop inspections and, depending on findings, replacement
of fan case LP fuel tubes, clips and FOHE mounting hardware.

    You may obtain further information by examining the MCAI in the AD
docket on the Internet at http://www.regulations.gov by searching for
and locating Docket No. FAA-2014-0363.

Relevant Service Information

    RR has issued Alert Non-Modification Service Bulletin (NMSB) No.
RB.211-73-AH522, Revision 1, dated March 18, 2014. The Alert NMSB
describes procedures for on-wing and in-shop inspection and replacement
if necessary, of the LP fuel tubes and FOHE mounts and associated
hardware.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of the
United Kingdom and is approved for operation in the United States.
Pursuant to our bilateral agreement with the European Community, EASA
has notified us of the unsafe condition described in the MCAI and
service information referenced above. We are proposing this AD because
we evaluated all information provided by EASA and determined the unsafe
condition exists and is likely to exist or develop on other products of
the same type design. This proposed AD would require inspection of
affected LP fuel tubes and FOHE mounts and associated hardware and, if
necessary, replacement with a part eligible for installation.

Costs of Compliance

    We estimate that this proposed AD would affect about 50 engines
installed on airplanes of U.S. registry. We also estimate that it would
take about 6 hours per engine to comply with this proposed AD. The
average labor rate is $85 per hour. Based on these figures, we

estimate the cost of this proposed AD on U.S. operators to be $25,500.

Authority for This Rulemaking

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

Regulatory Findings

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

Rolls-Royce plc: Docket No. FAA-2014-0363; Directorate Identifier
2014-NE-08-AD.

(a) Comments Due Date

    We must receive comments by September 2, 2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Rolls-Royce plc (RR) RB211 Trent 768-60,
772-60, and 772B-60 turbofan engines.

(d) Reason

    This AD was prompted by fuel leaks caused by damage to the fan
case low-pressure (LP) fuel tube. We are issuing this AD to prevent
failure of the fan case LP fuel tube, which could lead to an in-
flight shutdown of one or more engines due to fuel starvation, loss
of thrust control, and damage to the airplane.

(e) Actions and Compliance

    Comply with this AD within the compliance times specified,
unless already done.
    (1) For engines that have 3,200 or more flight hours since new
(FHSN) on the effective date of this AD, within 800 flight hours
(FHs) after the effective date of this AD, accomplish an on-wing
inspection of fan case LP fuel tubes, part number (P/N) FW53576, and
associated clips, and the fuel oil heat exchanger (FOHE) mounts and
associated hardware. Use paragraph 3.A. of RR Alert Non-Modification
Service Bulletin (NMSB) No. RB.211-73-AH522, Revision 1, dated March
18, 2014, to do the inspection. Thereafter, inspect at intervals not
to exceed 4,000 FHs.
    (2) For engines that have less than 3,200 FHSN on the effective
date of this AD, before exceeding 4,000 FHSN, accomplish an on-wing
inspection of fan case LP fuel tubes, P/N FW53576, and associated
clips, and the FOHE mounts and associated hardware. Use paragraph
3.A. of RR Alert NMSB No. RB.211-73-AH522, Revision 1, dated March
18, 2014, to do the inspection. Thereafter, inspect at intervals not
to exceed 4,000 FHs.
    (3) After the effective date of this AD, during each engine shop
visit, inspect the fan case LP fuel tubes, P/Ns FW26589, FW36335,
FW26587, FW535776, and FW53577, and associated clips, and the FOHE
mounts and associated hardware. Use paragraph 3.B. of RR Alert NMSB
No. RB.211-73-AH522, Revision 1, dated March 18, 2014, to do the
inspection.
    (4) If any inspection required by paragraphs (e)(1), (e)(2), or
(e)(3) of this AD fails, replace the affected part with a part
eligible for installation.

(f) Credit for Previous Actions

    (1) If, before the effective date of this AD, you performed the
inspections and corrective actions required by paragraphs (e)(1),
(e)(2), or (e)(3) of this AD using RR Alert NMSB No. RB.211-72-
AH522, dated September 20, 2013, you met the initial inspection
requirements of paragraphs (e)(1), (e)(2), or (e)(3) of this AD.
    (2) Any inspections and corrective actions performed before the
effective date of this AD are not terminating action for the
repetitive inspections required by paragraphs (e)(1), (e)(2), and
(e)(3) of this AD.

(g) Definitions

    For the purposes of this AD:
    (1) An ``engine shop visit'' is the induction of an engine into
the shop for maintenance involving the separation of pairs of major
mating engine flanges, except that the separation of engine flanges
solely for the purposes of transportation without subsequent engine
maintenance is not an engine shop visit.
    (2) The fan case LP fuel tubes and associated clips, and the
FOHE mounts and associated hardware are eligible for installation if
they have passed the inspection requirements of paragraphs (e)(1),
(e)(2), and (e)(3) of this AD.

(h) Alternative Methods of Compliance (AMOCs)

    The Manager, Engine Certification Office, FAA, may approve AMOCs
to this AD. Use the procedures found in 14 CFR 39.19 to make your
request.

(i) Related Information

    (1) For more information about this AD, contact Wego Wang,
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) Refer to MCAI European Aviation Safety Agency AD 2014-0089,
dated April 15, 2014, for more information. You may examine the MCAI
in the AD docket on the Internet at http://www.regulations.gov by
searching for and locating it in Docket No. FAA-2014-0363.
    (3) RR Alert NMSB No. RB.211-73-AH522, Revision 1, dated March
18, 2014, which is not incorporated by reference in this AD, can be
obtained from Rolls-Royce plc using the contact information in
paragraph (i)(4) of this AD.
    (4) For service information identified in this AD, contact
Rolls-Royce plc, Corporate Communications, P.O. Box 31, Derby,
England, DE248BJ; phone: 011-44-1332-242424; fax: 011-44-1332-
249936; email: http://www.rolls-royce.com/contact/civil_team.jsp;
Web site: https://www.aeromanager.com.
    (5) 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>.

    Issued in Burlington, Massachusetts, on June 27, 2014.
Colleen M. D'Alessandro,
Assistant Directorate Manager, Engine & Propeller Directorate, Aircraft
Certification Service.
[FR Doc. 2014-15620 Filed 7-2-14; 8:45 am]
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