[Federal Register Volume 87, Number 200 (Tuesday, October 18, 2022)]
[Notices]
[Pages 63079-63080]
[FR Doc No: 2022-22616]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0286]

Tissue Agnostic Drug Development in Oncology; Draft Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Tissue
Agnostic Drug Development in Oncology.'' For the purpose of this
guidance, the term ``tissue agnostic oncology drug'' refers to a drug
that targets a specific molecular alteration(s) (a kind of biomarker)
across multiple cancer types as defined, for example by organ, tissue,
or tumor type. This draft guidance describes the development of tissue
agnostic drugs, scientific considerations in determining when tissue
agnostic oncology drug development may be appropriate, and, if
appropriate, issues to be addressed during such development. Tissue
agnostic drug development may expedite or enable the development of new
therapies for patients with rare cancer types.

DATES: Submit either electronic or written comments on the draft
guidance by December 19, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-2022-D-0286 for ``Tissue Agnostic Drug Development in Oncology.''
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,<PHONE_NUMBER>.
     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.govinfo.gov/content/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,<PHONE_NUMBER>.
    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 draft 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; or the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. The draft guidance may also be obtained by mail by
calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.

FOR FURTHER INFORMATION CONTACT: Steven Lemery, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2374, Silver Spring, MD 20993-0002, 301-
796-2276; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Tissue Agnostic Drug Development in Oncology.'' This draft
guidance provides recommendations to sponsors regarding considerations
for tissue agnostic drug development in oncology. For the purpose of
this guidance, the term ``tissue agnostic oncology drug'' refers to a
drug that targets a specific molecular alteration(s) (a kind of
biomarker) across multiple cancer types as defined, for example by
organ, tissue, or tumor type. A tissue agnostic oncology drug can
therefore be used to treat multiple types of cancer (e.g., colorectal,
thyroid, and breast cancers) with the targeted molecular alteration
(e.g., either the same targeted molecular alteration or targeted
molecular alterations affecting a single pathway). The guidance
discusses the need in tissue agnostic drug development to generalize
treatment effects based on data observed in some cancer types to other
cancer types with the same targeted molecular alteration, when no
subjects (or a limited number of subjects) with the other cancer types
were included in the clinical trial(s). Such an approach may expedite
or enable the development of new therapies for patients with rare
cancer types when it may not be feasible to test the drug in an
adequate number of subjects for every cancer type.
    The draft guidance describes factors that sponsors should consider
when determining whether a tissue agnostic oncology drug development
program may be scientifically and clinically appropriate, such as
biology, subject population, clinical pharmacology, and clinical safety
and efficacy. In addition, the draft guidance describes issues to be
addressed in a tissue agnostic drug development program, such as
nonclinical assessment, subject selection, study designs, statistical
considerations, endpoints, pediatrics, diagnostic considerations,
postapproval data and information, and labeling.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Tissue
Agnostic Drug Development in Oncology.'' 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.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312 have been approved under OMB control
number 0910-0014. The collections of information in 21 CFR part 314
have been approved under OMB control number 0910-0001. The collections
of information in 21 CFR part 601 have been approved under OMB control
number 0910-0338. The collections of information in 21 CFR 201.56 and
201.57 have been approved under OMB control number 0910-0572.

III. Electronic Access

    Persons with access to the internet may obtain an electronic
version of the draft guidance at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: October 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22616 Filed 10-17-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 82 (Friday, April 27, 2012)]
[Rules and Regulations]
[Pages 25087-25088]
[FR Doc No: 2012-10098]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 60

[EPA-HQ-OAR-2009-0559; FRL-9664-9]
RIN 2060-AP90

Denial of Reconsideration Petitions on Standards of Performance
for New Stationary Sources and Emission Guidelines for Existing
Sources: Sewage Sludge Incineration Units

AGENCY: Environmental Protection Agency (EPA).

ACTION: Denial of petitions for reconsideration.

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SUMMARY: The EPA is providing notice that it has denied two petitions
for reconsideration of a final rule published in the Federal Register
on March 21, 2011. The rule established new source performance
standards and emission guidelines for sewage sludge incineration units
located at wastewater treatment facilities designed to treat domestic
sewage sludge, and was issued pursuant to the EPA's authority under
Clean Air Act section 129 to regulate solid waste incineration units.
After publication of the rule, the EPA received petitions for
reconsideration of the final rule from the National Association of
Clean Water Agencies (NACWA) (dated May 24, 2011) and the Sierra Club
(dated May 20, 2011). After carefully considering the petitions and
supporting information, in reaching a decision on the petitions, EPA
Administrator Lisa P. Jackson denied the petitions for reconsideration
on April 6, 2012, in separate letters to the petitioners. EPA denied
the petitions because they fail to meet the procedural test for
reconsideration under CAA section 307(d)(7)(B), and/or are not of
central relevance to the outcome of the rule, both of which are
necessary conditions precedent to granting reconsideration. The letters
explain in detail EPA's reasons for the denials.

FOR FURTHER INFORMATION CONTACT: Ms. Amy Hambrick, Sector Policies and
Programs Division (E143-03), Office of Air Quality Planning and
Standards, Environmental Protection Agency, Research Triangle Park,
North Carolina 27711; telephone number:<PHONE_NUMBER>; fax number:
(919) 541-3470; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. How can I get copies of this document and other related information?

    This Federal Register notice, the petitions for reconsideration,
and the letters denying the petitions for reconsideration are available
in the docket that the EPA established for the ``Standards of
Performance for New Stationary Sources and Emission Guidelines for
Existing Sources: Sewage Sludge Incineration Units'' under Docket ID
No. EPA-HQ-OAR-2009-0559. The document identification numbers for the
petitions for reconsideration are: Sierra Club, EPA-HQ-OAR-2009-0559-
0173; and NACWA, EPA-HQ-OAR-2009-0559-0174 (petition). The document
identification number for EPA's response letters are EPA-HQ-OAR-2009-
0559-0181. All documents in the docket are listed on the
www.regulations.gov Web site. Although listed in the index, some
information is not publicly available, e.g., confidential business
information or other information whose disclosure is restricted by
statute. Certain other material, such as copyrighted material, is not
placed on the Internet and will be publicly available only in hard copy
form. Publicly available docket materials are available either
electronically through www.regulations.gov or in hard copy at the EPA
Docket Center (Air Docket), EPA/DC, EPA West, Room 3334, 1301
Constitution Ave. NW., Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744 and the telephone number for the Air Docket is<PHONE_NUMBER>.
    This Federal Register notice, the petitions for reconsideration and
the letters denying the petitions can also be found on the EPA's Web
site at http://www.epa.gov/ttn/atw/129/ssi/ssipg.html. The ``Standards
of Performance for New Stationary Sources and Emission Guidelines for
Existing Sources: Sewage Sludge Incineration Units'' rules were
published in the Federal Register on March 21, 2011, at 76 FR 15372.

II. Judicial Review

    Any petitions for review of the letters denying the petitions for

reconsideration described in this Notice must be filed in the Court of
Appeals for the District of Columbia Circuit by June 26, 2012.

List of Subjects in 40 CFR Part 60

    Environmental protection, Administrative practice and procedure,
Air pollution control, Intergovernmental relations, Reporting and
recordkeeping requirements.

    Dated: April 18, 2012.
Lisa P. Jackson,
Administrator.
[FR Doc. 2012-10098 Filed 4-26-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: January 31, 2008 (Volume 73, Number 21)]
[Proposed Rules]
[Page 5773-5775]
[DOCID:fr31ja08-21]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0090; Directorate Identifier 2007-NM-312-AD]
RIN 2120-AA64

Airworthiness Directives; Boeing Model 747 Airplanes

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
certain Boeing Model 747 airplanes. This proposed AD would require
measuring the electrical bond resistance between the motor operated
valve (MOV) actuators and airplane structure for the main, center,
auxiliary, and horizontal stabilizer fuel tanks as applicable, and
corrective action if necessary. This proposed AD would also require a
revision to the FAA-approved maintenance program to incorporate
airworthiness limitation (AWL) No. 28-AWL-21 or AWL No. 28-AWL-27, as
applicable. This proposed AD results from fuel system reviews conducted
by the manufacturer. We are proposing this AD to prevent electrical
current from flowing through a MOV actuator into a fuel tank, which
could create a potential ignition source inside the fuel tank. This
condition, in combination with flammable fuel vapors, could result in a
fuel tank explosion and consequent loss of the airplane.

DATES: We must receive comments on this proposed AD by March 17, 2008.

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

Examining the AD Docket

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

FOR FURTHER INFORMATION CONTACT: Sulmo Mariano, Aerospace Engineer,
Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification
Office, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425) 917-6501; fax<PHONE_NUMBER>.

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-2008-0090;
Directorate Identifier 2007-NM-312-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The FAA has examined the underlying safety issues involved in fuel
tank explosions on several large transport airplanes, including the
adequacy of existing regulations, the service history of airplanes
subject to those regulations, and existing maintenance practices for
fuel tank systems. As a result of those findings, we issued a
regulation titled ``Transport Airplane Fuel Tank System Design Review,
Flammability Reduction and Maintenance and Inspection Requirements''
(66 FR 23086, May 7, 2001). In addition to new airworthiness standards
for transport airplanes and new maintenance requirements, this rule
included Special Federal Aviation Regulation No. 88 (``SFAR 88,''
Amendment 21-78, and subsequent Amendments 21-82 and 21-83).
    Among other actions, SFAR 88 requires certain type design (i.e.,
type certificate (TC) and supplemental type certificate (STC)) holders
to substantiate that their fuel tank systems can prevent ignition
sources in the fuel tanks. This requirement applies to type design
holders for large turbine-powered transport airplanes and for
subsequent modifications to those airplanes. It requires them to
perform design reviews and to develop design changes and maintenance
procedures if their designs do not meet the new fuel tank safety
standards. As explained in the preamble to the rule, we intended to
adopt airworthiness directives to mandate any changes found necessary
to address unsafe conditions identified as a result of these reviews.
    In evaluating these design reviews, we have established four
criteria intended to define the unsafe conditions associated with fuel
tank systems that require corrective actions. The percentage of
operating time during which fuel tanks are exposed to flammable
conditions is one of these criteria. The other three criteria address
the failure types under evaluation: Single failures, single failures in
combination with a latent condition(s), and in-service failure
experience. For all four criteria, the evaluations included
consideration of previous actions taken that may mitigate the need for
further action.
    We have determined that the actions identified in this AD are
necessary to reduce the potential of ignition sources inside fuel
tanks, which, in combination

with flammable fuel vapors, could result in fuel tank explosions and
consequent loss of the airplane.
    Boeing has found that, under specific conditions, it is possible
for electrical current to flow through a motor operated valve (MOV)
actuator into a fuel tank, which could create a potential ignition
source inside the fuel tank. This condition, if not corrected, in
combination with flammable fuel vapors could result in a fuel tank
explosion and consequent loss of the airplane.

Relevant Service Information

    We have reviewed Boeing Alert Service Bulletin 747-28A2292, dated
September 14, 2007, for Model 747-100, 747-100B, 747-100B SUD, 747-
200B, 747-200C, 747-200F, 747-300, 747-400, 747-400D, 747-400F, 747SR,
and 747SP series airplanes. The service bulletin describes procedures
for measuring the electrical bond resistance between the MOV actuators
and airplane structure for the main, center, and auxiliary fuel tanks,
and corrective action if necessary. The corrective action includes
reworking the index plate and cleaning the surface of the adapter plate
and airplane structure as necessary.
    We have also reviewed Boeing Alert Service Bulletin 747-28A2294,
dated September 21, 2007, for Model 747-400 series airplanes equipped
with an active horizontal stabilizer fuel tank. The service bulletin
describes procedures for measuring the electrical bond resistance
between the MOV actuators and airplane structure for the horizontal
stabilizer fuel tank, and corrective action if necessary. The
corrective action includes reworking the index plate and cleaning the
surface of the adapter plate and airplane structure as necessary.
    We have also reviewed the Boeing 747-100/200/300/SP Airworthiness
Limitations (AWLs) and Certification Maintenance Requirements (CMRs),
D6-13747-CMR, Revision January 2007 (hereafter referred to as
``Document D6-13747-CMR''). (For the purposes of Document D6-13747-CMR,
the Model 747SR series airplane is basically a Model 747-100 series
airplane with certain modifications to improve fatigue life.) Section D
of Document D6-13747-CMR describes new AWLs for fuel tank systems. The
AWLs include:
     AWL inspections, which are periodic inspections of certain
features for latent failures that could contribute to an ignition
source.
     Critical design configuration control limitations
(CDCCLs), which are limitation requirements to preserve a critical
ignition source prevention feature of the fuel tank system design that
is necessary to prevent the occurrence of an unsafe condition. The
purpose of a CDCCL is to provide instruction to retain the critical
ignition source prevention feature during configuration change that may
be caused by alterations, repairs, or maintenance actions. A CDCCL is
not a periodic inspection.
    Section D of Document D6-13747-CMR adds new fuel system AWL No. 28-
AWL-21, which is a CDCCL to maintain the design features of the MOV
actuator.
    We have also reviewed the Boeing 747-400 Maintenance Planning Data
(MPD) Document, D621U400-9, Section 9, Revision December 2006 R1
(hereafter referred to as the ``Boeing 747-400 MPD''). Subsection D of
the Boeing 747-400 MPD adds new fuel system AWL No. 28-AWL-27, which is
a CDCCL to maintain the design features of the MOV actuator.

FAA's Determination and Requirements of This Proposed AD

    We are proposing this AD because we evaluated all relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the(se) same type
design(s). This proposed AD would require the following actions:
     Measuring the electrical bond resistance between the MOV
actuators and airplane structure for the main, center, auxiliary, and
horizontal stabilizer fuel tanks as applicable, and corrective action
if necessary.
     Revising the FAA-approved maintenance program to
incorporate AWL No. 28-AWL-21, which would require maintaining the
design features of the MOV actuator on Model 747-100, 747-100B, 747-
100B SUD, 747-200B, 747-200C, 747-200F, 747-300, 747SR, and 747SP
series airplanes.
     Revising the FAA-approved maintenance program to
incorporate AWL No. 28-AWL-27, which would require maintaining the
design features of the MOV actuator on Model 747-400, 747-400D, and
747-400F series airplanes.

Costs of Compliance

    We estimate that this proposed AD would affect 300 airplanes of
U.S. registry. The following table provides the estimated costs, at an
average labor rate of $80 per hour, for U.S. operators to comply with
this proposed AD.

                                                                     Estimated Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
             Action                        Work hours                       Parts                   Cost per product                 Fleet cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
Measurements....................  Up to 447...................  Up to $350..................  Up to $36,110...............  Up to $10,833,000.
Maintenance program revision....  1...........................  None........................  $80.........................  $24,000.
--------------------------------------------------------------------------------------------------------------------------------------------------------

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), and
    3. Will not have a significant economic impact, positive or
negative,

on a substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
    You can find our regulatory evaluation and the estimated costs of
compliance in the AD Docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

Boeing: Docket No. FAA-2008-0090; Directorate Identifier 2007-NM-
312-AD.

Comments Due Date

    (a) We must receive comments by March 17, 2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Boeing Model 747-100, 747-100B, 747-100B
SUD, 747-200B, 747-200C, 747-200F, 747-300, 747-400, 747-400D, 747-
400F, 747SR, and 747SP series airplanes, certificated in any category;
as identified in Boeing Alert Service Bulletin 747-28A2292, dated
September 14, 2007.

    Note 1: 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 (j) of this AD. The request should include a
description of changes to the required inspections that will ensure
the continued operational safety of the airplane.

Unsafe Condition

    (d) This AD results from fuel system reviews conducted by the
manufacturer. We are issuing this AD to prevent electrical current from
flowing through a motor operated valve (MOV) actuator into a fuel tank,
which could create a potential ignition source inside the fuel tank.
This condition, in combination with flammable fuel vapors, could result
in a fuel tank explosion and consequent loss of the airplane.

Compliance

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

Measurement and Corrective Action

    (f) For all airplanes: Within 60 months after the effective date of
this AD, measure the electrical bond resistance between the MOV
actuators and airplane structure for the main, center, and auxiliary
fuel tanks as applicable, and do all the applicable corrective actions,
by accomplishing all of the applicable actions specified in the
Accomplishment Instructions of Boeing Alert Service Bulletin 747-
28A2292, dated September 14, 2007. The corrective actions must be
accomplished before further flight.
    (g) For Model 747-400 series airplanes identified in paragraph 1.A
of Boeing Alert Service Bulletin 747-28A2294, dated September 21, 2007:
Within 60 months after the effective date of this AD, measure the
electrical bond resistance between the MOV actuators and airplane
structure for the horizontal stabilizer fuel tanks, and do all the
applicable corrective actions, by accomplishing all of the applicable
actions specified in the Accomplishment Instructions of the service
bulletin. The corrective actions must be accomplished before further
flight.

Maintenance Program Revision

    (h) For Model 747-100, 747-100B, 747-100B SUD, 747-200B, 747-200C,
747-200F, 747-300, 747SR, and 747SP series airplanes: Concurrently with
accomplishing the actions required by paragraph (f) of this AD, revise
the FAA-approved maintenance program by incorporating AWL No. 28-AWL-21
of Section D of the Boeing 747-100/200/300/SP Airworthiness Limitations
(AWLs) and Certification Maintenance Requirements (CMRs), D6-13747-CMR,
Revision January 2007. Accomplishing the revision in accordance with a
later revision of Document D6-13747-CMR is an acceptable method of
compliance if the revision is approved by the Manager, Seattle Aircraft
Certification Office (ACO), FAA.
    (i) For Model 747-400, 747-400D, and 747-400F series airplanes:
Concurrently with accomplishing the applicable actions required by
paragraph (f) and (g) of this AD, revise the FAA-approved maintenance
program by incorporating AWL No. 28-AWL-27 of Subsection D of the
Boeing 747-400 Maintenance Planning Data (MPD) Document, D621U400-9,
Section 9, Revision December 2006 R1. Accomplishing the revision in
accordance with a later revision of the MPD is an acceptable method of
compliance if the revision is approved by the Manager, Seattle ACO,
FAA.

Alternative Methods of Compliance (AMOCs)

    (j)(1) The Manager, Seattle ACO, FAA, ATTN: Sulmo Mariano,
Aerospace Engineer, Propulsion Branch, ANM-140S, 1601 Lind Avenue, SW.,
Renton, Washington 98057-3356; telephone<PHONE_NUMBER>; fax (425) 917-
6590; has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19.
    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.

    Issued in Renton, Washington, on January 14, 2008.
Stephen P. Boyd,
Assistant Manager, Transport Airplane Directorate, Aircraft
Certification Service.
 [FR Doc. E8-1705 Filed 1-30-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 42 (Friday, March 2, 2012)]
[Notices]
[Pages 12896-12897]
[FR Doc No: 2012-5055]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66459; File No. 600-11]

Self-Regulatory Organizations; Pacific Clearing Corporation;
Order Cancelling Clearing Agency Registration

 February 24, 2012.

I. Background

    On December 1, 1975, pursuant to Sections 17A(b) and 19(a)(1) of
the Securities Exchange Act of 1934 (``Act'') \1\ and Rule 17Ab2-1
thereunder,\2\ the Securities and Exchange Commission (``Commission'')
approved on a temporary basis the application for registration as a
clearing agency filed by the Pacific Clearing Corporation (``PCC'').\3\
By subsequent orders, the Commission extended PCC's temporary
registration.\4\ On September 23, 1983, pursuant to Section 17A and
Rule 17Ab2-1 thereunder,\5\ the Commission approved on a permanent
basis PCC's registration as a clearing agency.\6\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78q-1(b) and 78s(a)(1).
    \2\ 17 CFR 240.17Ab2-1.
    \3\ Release No. 34-11875 (Nov. 26, 1975), 40 FR 55910 (Dec. 2,
1975).
    \4\ Release Nos. 34-13584 (June 1, 1977), 42 FR 30066 (Jun. 10,
1977); 34-13911 (Aug. 31, 1977), 1977 WL 190688; 34-14531, 43 FR
10288 (Mar. 10, 1978); and 34-18584 (Mar. 22, 1982), 47 FR 13266
(Mar. 29, 1982).
    \5\ 15 U.S.C. 78q-1 and 17 CFR 240.17Ab2-1.
    \6\ Release No. 34-20221 (Sept. 23, 1983), 48 FR 45167 (Oct. 3,
1983).
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    PCC was a subsidiary of PCX Equities, Inc. (``PCXE'') (now NYSE
Arca Equities, Inc.), which was a wholly owned subsidiary of the
Pacific

Exchange, Inc. (``PCX'') \7\ (now NYSE Arca, Inc. [``NYSE Arca'']).\8\
Prior to the transaction described below, PCC offered various clearance
and settlement services, such as trade recording for PCX-listed and
over-the-counter securities transactions, trade comparison, continuous
net settlement, and book-entry depository services.\9\
---------------------------------------------------------------------------

    \7\ Letter from Kathryn L. Beck, Senior Vice President, General
Counsel and Corporate Secretary, Pacific Stock Exchange, to Jerry W.
Carpenter, Assistant Director, Division of Market Regulation,
Commission (April 11, 2005) (``April 2005 Letter'').
    \8\ PCXE and PCC had previously been wholly owned subsidiaries
of Archipelago Holdings, Inc. Following the merger on March 6, 2006,
of New York Stock Exchange, Inc. with Archipelago Holdings, Inc.,
the PCX filed with the Securities and Exchange Commission a proposed
rule change, which was effective upon filing, that amended its rules
to reflect these name changes: From PCX to NYSE Arca; from PCX
Equities, Inc. to NYSE Arca Equities, Inc.; from PCX Holdings, Inc.,
to NYSE Arca Holdings, Inc.; and from the Archipelago Exchange,
L.L.C. to NYSE Arca, L.L.C. Release No. 34-53615, 71 FR 19226 (Apr.
13, 2006).
    \9\ Release No. 34-20221, supra note 6.
---------------------------------------------------------------------------

II. Cancellation of PCC's Registration as a Clearing Agency

    In an April 2005 Letter, PCX stated that on or about April 15,
1987, it had ``transferred substantially all of its principal
settlement and clearance activities to the National Security [sic]
Clearing Corporation (`NSCC').'' \10\ PCX further stated that on
September 13, 2003, the PCX Board of Governors and PCXE Board of
Directors voted to take all necessary steps to dissolve PCC.\11\
Finally, PCX represented, among other things, that pursuant to Rule
17a-1,\12\ PCX would retain at least one copy of all documents,
including all correspondence, memoranda, papers, books, notices,
accounts, and other such records of PCC in PCX's or PCXE's possession
for at least 5 years from the date of dissolution of PCC.\13\
---------------------------------------------------------------------------

    \10\ Letter from Kathryn L. Beck, Senior Vice President, General
Counsel and Corporate Secretary, Pacific Stock Exchange, to Jerry W.
Carpenter, Assistant Director, Division of Market Regulation,
Commission (April 11, 2005) (``April 2005 Letter'').
    \11\ Id. PCC was incorporated in California on April 28, 1955,
and was dissolved on August 7, 2007. LexisNexis, Public Records,
Corporate Filings search, http://www.lexis.com.
    \12\ 17 CFR 240.17a-1.
    \13\ April 2005 Letter. In addition, NYSE Euronext represented
to the Commission that as of August 26, 2011, it had not received
any requests over the last two years for documents relating to PCC
and that no claims relating to the operations of PCC had been made.
Email from Janet McGinness, Senior Vice President, Legal and
Corporate Secretary, NYSE Euronext, to David Karasik, Division of
Trading and Markets, Commission (Aug. 26, 2011).
     As a result of the business combination of NYSE Group, Inc. and
Euronext N.V., the businesses of NYSE Group, including that of the
NYSE LLC and NYSE Arca, and Euronext are now held under a single,
publicly traded holding company named NYSE Euronext. Release Nos.
34-55293 (Feb. 14, 2007), 72 FR 8033 (Feb. 22, 2007) and 34-55026
(Dec. 29, 2006), 72 FR 814 (Jan. 8, 2007).
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    Section 19(a)(3) of the Act \14\ provides that in the event any
self-regulatory organization is no longer in existence or has ceased to
do business in the capacity specified in its application for
registration, ``the Commission, by order, shall cancel its
registration.''
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(a)(3).
---------------------------------------------------------------------------

    Based upon the representations and undertakings made by PCX to the
Commission and because PCC is no longer in existence and has ceased to
do business in the capacity specified in its registration application,
the Commission is canceling its registration effective February 24,
2012.
    It is therefore ordered that:
    Effective February 24, 2012, based on the facts and representations
noted above, PCC's registration as a clearing agency under Section 17A
of the Exchange Act and Rule 17Ab2-1 thereunder is cancelled.

    By the Commission.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-5055 Filed 3-1-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 42 (Monday, March 6, 2017)]
[Notices]
[Page 12588]
[FR Doc No: 2017-04210]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG17-69-000.
    Applicants: Paulding Wind Farm IV LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Paulding Wind Farm IV LLC.
    Filed Date: 2/21/17.
    Accession Number: 20170221-5251.
    Comments Due: 5 p.m. ET 3/14/17.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER13-2483-002.
    Applicants: Old Dominion Electric Cooperative.
    Description: Compliance filing: Opinion No. 553 Compliance Filing
to be effective 1/1/2014.
    Filed Date: 2/21/17.
    Accession Number: 20170221-5274.
    Comments Due: 5 p.m. ET 3/14/17.

    Docket Numbers: ER16-791-001.
    Applicants: Southwest Power Pool, Inc.
    Description: Compliance filing: Compliance Filing in ER16-791--
Settlement Revenue Distribution Mechanism to be effective 2/1/2016.
    Filed Date: 2/22/17.
    Accession Number: 20170222-5054.
    Comments Due: 5 p.m. ET 3/15/17.

    Docket Numbers: ER16-2561-001.
    Applicants: Sunflower Wind Project, LLC.
    Description: Notice of Non-Material Change in Status of Sunflower
Wind Project, LLC.
    Filed Date: 2/21/17.
    Accession Number: 20170221-5294.
    Comments Due: 5 p.m. ET 3/14/17.

    Docket Numbers: ER17-1006-000.
    Applicants: AEP Generating Company.
    Description: Notice of Termination of Unit Power Sales Agreement
for Lawrenceburg Facility of AEP Generating Company.
    Filed Date: 2/21/17.
    Accession Number: 20170221-5292.
    Comments Due: 5 p.m. ET 3/14/17.

    Docket Numbers: ER17-1007-000.
    Applicants: Duke Energy Florida, LLC.
    Description: Tariff Cancellation: Termination of RS No. 217 DEF-
Phillips Plant Operating Agreement to be effective 2/23/2017.
    Filed Date: 2/22/17.
    Accession Number: 20170222-5053.
    Comments Due: 5 p.m. ET 3/15/17.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: February 22, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-04210 Filed 3-3-17; 8:45 am]
 BILLING CODE 6717-01-P