[Federal Register: April 1, 2010 (Volume 75, Number 62)]
[Rules and Regulations]
[Page 16347-16351]
[DOCID:fr01ap10-13]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 814

[Docket No. FDA-2009-N-0458]
RIN 0910-AG29

Medical Devices; Pediatric Uses of Devices; Requirement for
Submission of Information on Pediatric Subpopulations That Suffer From
a Disease or Condition That a Device Is Intended to Treat, Diagnose, or
Cure; Direct Final Rule

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Direct final rule.

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SUMMARY:  The Food and Drug Administration (FDA) is amending the
regulations on premarket approval of medical devices to include
requirements relating to the submission of information on pediatric
subpopulations that suffer from the disease or condition that a device
is intended to treat, diagnose, or cure. Elsewhere in this issue of the
Federal Register, we are publishing a companion proposed rule under
FDA's usual procedure for notice and comment to provide a procedural
framework to finalize the rule in the event we receive significant
adverse comment and withdraw this direct final rule.

DATES:  This rule is effective August 16, 2010. Submit electronic or
written comments on the direct final rule by June 15, 2010. Submit
electronic or written comments on the information collection
requirements by June 1, 2010. If we receive no significant adverse
comments within the specified comment period, we intend to publish a
document confirming the effective date of the final rule in the Federal
Register within 30 days after the comment period on this direct final
rule ends. If we receive any timely significant adverse comment, we
will withdraw this final rule in part or in whole by publication of a
document in the Federal Register within 30 days after the comment
period ends.

ADDRESSES:  You may submit comments, identified by Docket No. FDA-2009-
N-0458, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
    Submit written submissions in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the agency name
and docket number and regulatory information number (RIN) for this
rulemaking. All comments received may be posted without change to
http://www.regulations.gov, including any personal information
provided. For additional information on submitting comments, see the
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this
document.
    Docket: For access to the docket to read background documents or
comments received, go to http://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 Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Robert Gatling, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 1640, Silver Spring, MD 20993, 301-796-
6560.

SUPPLEMENTARY INFORMATION:

I. What Is the Background of This Rule?

    On September 27, 2007, the Food and Drug Administration Amendments
Act of 2007 (FDAAA)\1\ (Public Law 110-85) amended the Federal Food,
Drug, and Cosmetic Act (the act) by adding, among other things, a new
section 515A of the act (21 U.S.C. 360e-1). Section 515A(a) of the act
requires persons who submit certain medical device applications to
include readily available information providing a description of any
pediatric subpopulations that suffer from the disease or condition that
the device is intended to treat, diagnose, or cure, and the number of
affected pediatric patients. This rule amends FDA's regulations to
implement the requirements of section 515A(a) of the act.
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    \1\ Title III of FDAAA, which includes new section 515A, is also
known as the Pediatric Medical Device Safety and Improvement Act of
2007.
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    Section 515A(c) of the act states that, for the purposes of that
section, the term ``pediatric subpopulation'' has the meaning given the
term in section 520(m)(6)(E)(ii) of the act (21 U.S.C.
360j(m)(6)(E)(ii)). Section 520(m)(6)(E)(ii) of the act defines the
term ``pediatric subpopulation'' to mean one of the following
populations:
     Neonates;
     Infants;
     Children; or
     Adolescents.
    We have previously issued guidance recommending the age range for
each of the populations included in the term ``pediatric
subpopulation.'' See Premarket Assessment of Pediatric Medical Devices
(May 14, 2004); (http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/ucm089740.htm).
    The term ``pediatric patient'' is defined, for purposes of section
520(m)(6)(E)(i) of the act as patients who are 21 years of age or
younger at the time of the diagnosis or treatment. Because no other
definition of ``pediatric patient'' is included in the Pediatric
Medical Device Safety and Improvement Act of 2007, and because the
definition in section 520(m)(6)(E)(i) of the act is consistent with the
definition of pediatric subpopulations in section 520(m)(6)(E)(ii), FDA
has concluded that the term ``pediatric patient'' in section 515A of
the act refers to patients who are 21 years of age or younger at the
time of the diagnosis or treatment.
    The information submitted under section 515A(a) of the act will
help FDA track the following information that it is required to report
annually to Congress, in accordance with section 515A(a)(3) of the act:
     The number of approved devices for which there is a
pediatric subpopulation that suffers from the disease or condition that
the device is intended to treat, diagnose, or cure;
     The number of approved devices labeled for use in
pediatric patients;
     The number of approved pediatric devices that were
exempted from a review fee under section 738(a)(2)(B)(v) of the act (21
U.S.C. 379j(a)(2)(B)(v)); and
     The review time for each such device.

II. What Applications Are Subject to This Rule?

    In accordance with the act, these requirements apply to the
following applications when submitted on or after the effective date of
this rule:
     Any request for a humanitarian device exemption (HDE)
submitted under section 520(m) of the act;
     Any premarket approval application (PMA) or supplement to
a PMA submitted under section 515 of the act; and
     Any product development protocol (PDP) submitted under
section 515 of the act.
    If the applicant of a supplement to a PMA has previously submitted
information satisfying these requirements, the applicant may
incorporate that information by reference rather than resubmitting the
same information. However, if additional information has become readily
available to the applicant since the previous submission, the applicant
must submit that information as part of the supplement.
    Many PMAs begin with the submission of one or more PMA modules; see
Premarket Approval Application Modular Review--Guidance for Industry
and FDA Staff, available at http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/ucm089764.htm. Applicants
who choose to use the modular approach should submit the information
required by section 515A(a) of the act in the final PMA module (i.e.,
the module that includes final clinical data, proposed labeling, and
the summary of safety and effectiveness).

III. What Does This Direct Final Rule Do?

    This direct final rule implements new section 515A(a) of the act by
amending 21 CFR Part 814, Premarket Approval of Medical Devices, to
include requirements relating to the submission of information on
pediatric subpopulations that suffer from the disease or condition that
a device is intended to treat, diagnose, or cure.

A. What Information Must Be Provided?

    This rule requires each applicant who submits an HDE, PMA,
supplement to a PMA, or PDP to include, if ``readily available,'' a
description of any pediatric subpopulations that suffer from the
disease or condition that the device is intended to treat, diagnose, or
cure, and the number of affected pediatric patients.

B. What Are the Consequences of Not Submitting ``Readily Available''
Information?

    If you do not submit the information required by section 515A(a) of
the act, FDA may not approve your application until you provide the
required information. We intend to contact you during the normal course
of our review to inform you that your submission lacks the information
required by section 515A(a) of the act and by this rule, and to ask you
to amend your application to provide the required information. If your
application has no other deficiencies and otherwise meets applicable
statutory and regulatory requirements for approval, but still lacks
information required by section 515A(a) of the act, we intend to send
you an ``approvable'' letter informing you that we will approve your
application after you provide the information required by section
515A(a). If your application has other deficiencies or does not meet
all applicable statutory and regulatory requirements for approval, we
intend to send you a ``not approvable'' letter or a ``major
deficiency'' letter describing what information or data you need to
provide before FDA can approve your application; the ``not approvable''
or ``major deficiency'' letter may cite the absence of 515A(a)
information in the section listing minor deficiencies. For additional
information concerning the interactive process we will use during our
review, see Guidance for Industry and FDA Staff: Interactive Review for
Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements,
Original BLAs, and BLA Supplements, available at http://www.fda.gov/
MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/
ucm089402.htm. For additional information concerning ``approvable,''
``not approvable,'' and ``major deficiency'' letters, see FDA and
Industry Actions on Premarket Approval Applications (PMAs): Effect on
FDA Review Clock and Goals, available at http://www.fda.gov/
MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/
ucm089733.htm.

IV. What Are the Procedures for Issuing a Direct Final Rule?

    In the Federal Register of November 21, 1997 (62 FR 62466), FDA
announced the availability of the guidance document entitled ``Guidance
for FDA and Industry: Direct Final Rule Procedures'' that described
when and how we will employ direct final rulemaking. We believe that
this rule is appropriate for direct final rulemaking because it is
intended to make noncontroversial amendments and minor corrections to
existing regulations. We anticipate no significant adverse comment.
    Consistent with FDA's procedures on direct final rulemaking, we are
publishing elsewhere in this issue of the Federal Register a companion
proposed rule that is identical in substance to this direct final rule.
The companion proposed rule provides a procedural framework within
which the rule may be finalized in the event the direct final rule is
withdrawn because of any significant adverse comment. The comment
period for this direct final rule runs concurrently with the comment
period of the companion proposed rule. Any comments received in
response to the companion proposed rule will also be considered as
comments regarding this direct final rule.
    If we receive any significant adverse comment, we intend to
withdraw this final rule before its effective date by publishing a
notice in the Federal Register within 30 days after the comment period
ends. A significant adverse comment is defined as a comment that
explains why the rule would be inappropriate, including challenges to
the rule's underlying premise or approach, or would be ineffective or
unacceptable without change. In determining whether an adverse comment
is significant and warrants withdrawing a direct final rulemaking, we
will consider whether the comment raises an issue serious enough to
warrant a substantive response in a notice-and-comment process in
accordance with section 553 of the Administrative Procedure Act (APA)
(5 U.S.C. 553). Comments that are frivolous, insubstantial, or outside
the scope of the rule will not be considered a significant adverse
comment, unless the comment states why the rule would be ineffective
without the additional change. In addition, if a significant adverse
comment applies to part of a rule and that part can be severed from the
remainder of the rule, we may adopt as final those parts of the rule
that are not the subject of a significant adverse comment.
    If we withdraw the direct final rule, all comments received will be
considered under the companion proposed rule in developing a final rule
under the usual notice-and-comment procedures under the APA (5 U.S.C.
552a et seq.). If we receive no significant adverse comment during the
specified comment period, we intend to publish a confirmation document
in the Federal Register within 30 days after the comment period ends.

V. What Is the Legal Authority for This Rule?

    This rule, if finalized, would amend Sec. Sec.  814.1, 814.2,
814.20, 814.37, 814.39, 814.44, 814.100, 814.104, and 814.116. FDA's
legal authority to modify 814.1, 814.2, 814.20, 814.37, 814.39, 814.44,
814.100, 814.104 and 814.116 arises from the same authority under which
FDA initially issued these regulations, the device and general
administrative provisions of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321, 331, 351, 352, 360e, 360e-1, 360j, and 371).

VI. What Is the Environmental Impact of This Rule?

    FDA has determined under 21 CFR 25.30(h) and 25.34(a) that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.

VII. What Is the Economic Impact of This Rule?

    We have examined the impacts of this rule under Executive Order
12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the
Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). We believe that this
direct final rule is not a significant regulatory action as defined by
the Executive order.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this regulation only requires that some
submissions include a small amount of readily available information,
creating little additional burden, the agency certifies that the direct
final rule will not have a significant economic impact on a substantial
number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $133 million, using the most current (2008) Implicit
Price Deflator for the Gross Domestic Product. We do not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.
    We believe that the only costs to industry are those that we
account for in our Paperwork Reduction Act analysis, which immediately
follows this section. The rule does not require additional clinical
research or other costly efforts, and simply requires the applicant to
briefly summarize readily available information that will have been
reviewed by the applicant during the course of its development of the
device and preparation of its application to FDA. We have also limited
the rule to exclude supplements that do not involve a new intended use;
if a supplement does not involve a new intended use, we do not expect
the applicant will have new information pertinent to the requirement of
section 515A(a) of the act and this rule, and the limitation avoids the
needless submission of duplicate information to FDA. We expect FDA's
additional costs will be inconsequential, as the information required
here will be filed and managed as an integral part of each submission,
using existing filing, storage, and data management systems and
processes.

VIII. How Does the Paperwork Reduction Act of 1995 Apply to This Rule?

    This direct final rule contains information collection requirements
that are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
title, description, and respondent description of the information
collection provisions are shown below with an estimate of the annual
reporting burden. Included in the estimate is the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing each
collection of information. FDA invites comments on: (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 techniques, when
appropriate, and other forms of information technology.
    Title: Medical Devices; Pediatric Uses of Devices; Requirement for
Submission of Information on Pediatric Subpopulations That Suffer From
a Disease or Condition That a Device Is Intended to Treat, Diagnose, or
Cure.
    Description: Section 515A(a) of FDAAA requires applicants who
submit certain medical device applications to include readily available
information providing a description of any pediatric subpopulations
that suffer from the disease or condition that the device is intended
to treat, diagnose, or cure, and the number of affected pediatric
patients. The information submitted will allow FDA to track the number
of approved devices for which there is a pediatric subpopulation that
suffers from the disease or condition that the device is intended to
treat, diagnose, or cure; the number of approved devices labeled for
use in pediatric patients; the number of approved pediatric devices
that were exempted from a review fee under section 738(a)(2)(B)(v) of
the act; and the review time for each such device.
    Description of Respondents: These requirements apply to applicants
who submit the following applications when submitted on or after the
effective date of this rule:
     Any request for an HDE submitted under section 520(m) of
the act;
     Any PMA submitted under section 515 of the act;
     Any PDP submitted under section 515 of the act; and
     Any supplement to an HDE, PMA, or PDP that proposes a new
intended use, whether for an adult population or a pediatric
population.
    Burden: FDA estimates the burden of this collection of information
as follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                              No. of         Annual Frequency       Total Annual        Hours per
                    21 CFR Section                         Respondents         per Response          Responses           Response         Total Hours
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814.20(b)(3)(i)                                                        25                     1                 25                  4                100
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814.37(b)(2)                                                           10                     1                 10                  4                 40
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814.39(h)                                                              10                     1                 10                  4                 40
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814.104(b)(6)                                                           5                     1                  5                  4                 20
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Totals                                                                                200
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    All that is required is to access, organize, and submit information
that is readily available, using any approach that meets the
requirements of section 515A(a) of the act and this rule. FDA expects
to receive approximately 40 original PMA/PDP/HDE applications each
year, 5 of which FDA expects to be HDEs. This estimate is based on the
actual average of FDA's receipt of new PMA applications in FY 2007
through FY 2008. The agency estimates that 10 of those 40 original PMA
submissions will fail to provide the required pediatric use information
and their sponsors will therefore be required to submit PMA amendments.
The agency also expects to receive 10 supplements that describe a new
indication for use and will include the pediatric use information
required by 515A(a) of the act and this rule. We believe that because
the rule requires that the applicant organize and submit only readily
available information or a description of the methodology employed to
determine whether information required is readily available, no more
than 4 hours will be required to comply with section 515A(a) of the act
and this rule. FDA estimates that the total burden created by this rule
is 200 hours.
    We based this estimate on our experience with similar information
collection requirements and on consultations with the Interagency
Pediatric Devices Working Group which includes the Agency for
Healthcare Research and Quality, FDA, National Institutes of Health,
members of the Pediatric Advisory Committee, researchers, healthcare
practitioners, medical device trade associations, and medical device
manufacturers.
    As provided in 5 CFR 1320.5(c)(1), collections of information in a
direct final rule are subject to the procedures set forth in 5 CFR
1320.10. Interested persons and organizations may submit comments on
the information collection requirements of this direct final rule (see
DATES), to the Division of Dockets Management (see ADDRESSES).
    At the close of the 60-day comment period, FDA will review the
comments received, revise the information collection provisions as
necessary, and submit these provisions to OMB for review. FDA will
publish a notice in the Federal Register when the information
collection provisions are submitted to OMB, and an opportunity for
public comment to OMB will be provided at that time. Prior to the
effective date of the direct final rule, FDA will publish a notice in
the Federal Register of OMB's decision to approve, modify, or
disapprove the information collection provisions. 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.

IX. What Are the Federalism Impacts of This Rule?

    FDA has analyzed this direct final rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
the rule does not contain policies that have substantial direct effects
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. Accordingly, we have concluded that
the rule does not contain policies that have federalism implications as
defined in the Executive order and, consequently, a federalism summary
impact statement is not required.

X. How Do You Submit Comments on This Rule?

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments regarding this direct
final rule. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Comments are to be identified with the docket number found
in brackets in the heading of this document. Received comments may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.

List of Subjects in 21 CFR Part 814

    Administrative practice and procedure, Confidential business
information, Medical devices, Medical research, Reporting and
recordkeeping requirements.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
814 is amended as follows:

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

0
1. The authority citation for 21 CFR part 814 continues to read as
follows:

    Authority:  21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372,
373, 374, 375, 379, 379e, 381.

0
2. In Sec.  814.1, revise paragraph (a) to read as follows:

Sec.  814.1   Scope.

    (a) This section implements sections 515 and 515A of the act by
providing procedures for the premarket approval of medical devices
intended for human use.
* * * * *

0
3. Revise Sec.  814.2 to read as follows:

Sec.  814.2   Purpose.

    The purpose of this part is to establish an efficient and thorough
device review process--
    (a) To facilitate the approval of PMAs for devices that have been
shown to be safe and effective and that otherwise meet the statutory
criteria for approval;
    (b) To ensure the disapproval of PMAs that have not been shown to
be safe and effective or that do not otherwise meet the statutory
criteria for approval; and

    (c) To ensure PMAs include readily available information concerning
actual and potential pediatric uses of medical devices.

0
4. In Sec.  814.20, revise paragraph (b)(3)(i) to read as follows:

Sec.  814.20   Application.

* * * * *
    (b) * * *
    (3) * * *
    (i) Indications for use. (A) A general description of the disease
or condition the device will diagnose, treat, prevent, cure, or
mitigate, including a description of the patient population for which
the device is intended.
    (B) Information concerning uses in pediatric patients who are 21
years of age or younger: The application must include the following
information, if readily available:
    (1) A description of any pediatric subpopulations (neonates,
infants, children, adolescents) that suffer from the disease or
condition that the device is intended to treat, diagnose, or cure; and
    (2) The number of affected pediatric patients.
* * * * *

0
5. In Sec.  814.37, revise the section heading and paragraph (b) to
read as follows:

Sec.  814.37   PMA amendments and resubmitted PMAs.

* * * * *
    (b)(1) FDA may request the applicant to amend a PMA or PMA
supplement with any information regarding the device that is necessary
for FDA or the appropriate advisory committee to complete the review of
the PMA or PMA supplement.
    (2) FDA may request the applicant to amend a PMA or PMA supplement
with information concerning pediatric uses as required under Sec.
814.20(b)(3)(i).
* * * * *

0
6. In Sec.  814.39, add paragraph (h) to read as follows:

Sec.  814.39   PMA supplements.

* * * * *
    (h) The application must include the following information, if
readily available:
    (1) A description of any pediatric subpopulations (neonates,
infants, children, adolescents) that suffer from the disease or
condition that the device is intended to treat, diagnose, or cure; and
    (2) The number of affected pediatric patients who are 21 years of
age or younger.
    (3) If information concerning the device that is the subject of the
supplement was previously submitted under Sec.  814.20(b)(3)(i), that
information may be incorporated by reference to the application or
submission that contains the information. However, if additional
information required under Sec.  814.20(b)(3)(i) has become readily
available to the applicant since the previous submission, the applicant
must submit that information as part of the supplement.

0
7. In Sec.  814.44, redesignate paragraphs (e)(1)(ii) through
(e)(1)(iv) as paragraphs (e)(1)(iii) through (e)(1)(v), respectively,
and add new paragraph (e)(1)(ii) to read as follows:

Sec.  814.44  Procedures for review of a PMA.

* * * * *
    (e) * * *
    (1) * * *
    (ii) The submission of additional information concerning potential
pediatric uses required by Sec.  814.20(b)(3)(i) that is readily
available to the applicant;
* * * * *

0
8. Amend Sec.  814.100 as follows:
0
a. Redesignate paragraphs (b) through (e) as paragraphs (d) through
(g), respectively;
0
b. Redesignate paragraph (a) as paragraph (b), and remove the first
sentence of newly redesignated paragraph (b); and
0
c. Add new paragraphs (a) and (c) to read as follows:

Sec.  814.100   Purpose and scope.

    (a) This subpart H implements sections 515A and 520(m) of the act.
* * * * *
    (c) Section 515A of the act is intended to ensure the submission of
readily available information concerning actual and potential pediatric
uses of medical devices.
* * * * *

0
9. Amend Sec.  814.104 as follows:
0
a. Revise the last sentence of paragraph (b)(4)(ii);
0
b. Revise the last sentence of paragraph (b)(5); and
0
c. Add paragraph (b)(6) to read as follows:

Sec.  814.104   Original applications.

* * * * *
    (b) * * *
    (4) * * *
    (ii) * * * The effectiveness of this device for this use has not
been demonstrated.
    (5) * * * If the amount charged is $250 or less, the requirement
for a report by an independent certified public accountant or an
attestation by a responsible individual of the organization is waived;
and
    (6) Readily available information concerning actual and potential
pediatric uses of the device, as required by Sec.  814.20(b)(3)(i).
* * * * *

0
10. In Sec.  814.116, redesignate paragraphs (c)(2) through (c)(4) as
paragraphs (c)(3) through (c)(5), respectively, and add new paragraph
(c)(2) to read as follows:

Sec.  814.116   Procedures for review of an HDE.

* * * * *
    (c) * * *
    (2) The submission of additional information concerning potential
pediatric uses required by Sec.  814.20(b)(3)(i) that is readily
available to the applicant;
* * * * *

    Dated: March 17, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-7193 Filed 3-31-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 78, Number 238 (Wednesday, December 11, 2013)]
[Notices]
[Pages 75343-75344]
[FR Doc No: 2013-29592]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2013-0026; FRL-9903-52]

Pesticide Products; Registration Applications for New Active
Ingredients

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has received several applications to register pesticide
products containing active ingredients not included in any currently
registered pesticide products. Pursuant to the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), EPA is hereby providing notice
of receipt and opportunity to comment on these applications.

DATES: Comments must be received on or before January 10, 2014.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number and the EPA File Symbol of interest as shown in the body of
this document, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Robert McNally, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>, email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in

accordance with procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Registration Applications

    EPA has received several applications to register pesticide
products containing active ingredients not included in any currently
registered pesticide products. Pursuant to the provisions of FIFRA
section 3(c)(4), EPA is hereby providing notice of receipt and
opportunity to comment on these applications. Notice of receipt of
these applications does not imply a decision by the Agency on these
applications. For actions being evaluated under the Agency's public
participation process for registration actions, there will generally be
an additional opportunity for a public comment period on the proposed
decision. Please see the Agency's public participation Web site for
additional information on this process (http://www.epa.gov/pesticides/regulating/registration-public-involvement.html). EPA received the
following applications to register pesticide products containing an
active ingredient not included in any currently registered products:
    1. EPA File Symbols: 73314-O (technical product) and 73314-RN (end-
use product). Docket ID number: EPA-HQ-OPP-2013-0665. Applicant:
Novozymes BioAg, Inc., 13100 W. Lisbon Road, Suite 600, Brookfield, WI
53005. Active ingredient: Chromobacterium subtsugae strain SB3872.
Product type: Microbial insecticide. Proposed uses: Commercial ground
and aerial applications to food and non-food crops, lawns, golf
courses; seed treatments; residential home and garden uses.
    2. EPA File Symbols: 89600-E and 89600-R. Docket ID number: EPA-HQ-
OPP-2013-0718. Applicant: Anatis Bioprotection, Inc., 278, rang Saint-
Andr[eacute], St-Jacques-le-Mineur, Quebec JOJ 1Z0, Canada (represented
by Technology Sciences Group, Inc., 712 Fifth St., Suite A, Davis CA
95616). Active ingredient: Beauveria bassiana strain ANT-03. Product
type: Microbial insecticide. Proposed uses: Foliar-applied insecticide
to protect turf, horticultural or agricultural plants in the field or
greenhouse.

List of Subjects

    Environmental protection, Pesticides and pest.

    Dated: December 2, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2013-29592 Filed 12-10-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 76 (Monday, April 20, 2020)]
[Notices]
[Pages 21910-21911]
[FR Doc No: 2020-08337]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; 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:
    Rule 102; SEC File No. 270-409, OMB Control No. 3235-0467
    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget (``OMB'') a request for approval of extension of the
previously approved collection of information provided for in Rule 102
of Regulation M (17 CFR 242.102), under the Securities Exchange Act of
1934 (15 U.S.C. 78a et seq.).
    Rule 102 prohibits distribution participants, issuers, and selling
security holders from purchasing activities at specified times during a
distribution of securities. Persons otherwise covered by this rule may
seek to use several applicable exceptions such as an exclusion for
actively traded reference securities and the maintenance of policies
regarding information barriers between their affiliates.
    There are approximately 955 respondents per year that require an
aggregate total of 1,855 hours to comply with this rule. Each
respondent makes an estimated 1 annual response. Each response takes on
average approximately 1.942 hours to complete. Thus, the total
compliance burden per year is 1,855 burden hours. The total internal
compliance cost for all respondents is approximately $129,850.00,
resulting in an internal cost of compliance per respondent of
approximately $135.97 (i.e., $129,850.00/955 respondents).
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    The public may view background documentation for this information

collection at the following website: www.reginfo.gov. Find this
particular information collection by selecting ``Currently under 30-day
Review--Open for Public Comments'' or by using the search function.
Written comments and recommendations for the proposed information
collection should be sent within 30 days of publication of this notice
to (i) www.reginfo.gov/public/do/PRAMain and (ii) David Bottom,
Director/Chief Information Officer, Securities and Exchange Commission,
c/o Cynthia Roscoe, 100 F Street NE, Washington, DC 20549, or by
sending an email to<EMAIL_ADDRESS>
    Dated: April 15, 2020.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-08337 Filed 4-17-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 237 (Monday, December 12, 2022)]
[Proposed Rules]
[Pages 75973-75974]
[FR Doc No: 2022-26910]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

Proposed Modification of Class C Airspace at Luis Munoz Marin
International Airport, San Juan, PR; Informal Airspace Meeting

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

ACTION: Notice of meeting.

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

SUMMARY: This notice announces a fact-finding informal airspace meeting
regarding a plan to modify the Class C Airspace at Luis Munoz Marin
International Airport (TJSJ), San Juan, PR. The meeting will be a
virtual format via the Zoom platform. The purpose of the meeting is to
solicit aeronautical comments on the proposal's effects on local
aviation operations. All comments received during the meeting, and the
subsequent comment period, will be considered prior to the issuance of
a notice of proposed rulemaking.

DATES: The meeting will be held on Tuesday, February 28, 2023, from 5
to 7 p.m. Atlantic Standard Time (4 to 6 p.m. Eastern Standard Time).
Comments must be received on or before March 28, 2023.

ADDRESSES: Send comments on the proposal, in triplicate, to: Matthew
Cathcart, Acting Manager, Operations Support Group, Eastern Service
Area, Air Traffic Organization, Federal Aviation Administration, 1701
Columbia Avenue, College Park, Georgia 30337 or via email to: [email protected].

FOR FURTHER INFORMATION CONTACT: John Melecio, Air Traffic Manager, San
Juan CERAP, 5000 Carretera 190, Carolina, Puerto Rico 00979. Telephone
Number<PHONE_NUMBER>. Email: [email protected].

SUPPLEMENTARY INFORMATION:

Meeting Procedures

    (a) Registration: To attend the meeting, the public can register
here: https://us06web.zoom.us/webinar/register/WN_dX3NizSvQV-ab1vzFbxn-Q.
    (b) The meeting will be open to all persons on a space-available
basis. There is no admission fee or other charge to attend and
participate. The meeting will be informal in nature and will be
conducted by one or more representatives of the FAA Eastern Service
Area.
    (c) Each participant will be given an opportunity to deliver
comments or make a presentation, although a time limit may be imposed.
Only comments concerning the plan to modify the San Juan Class C
airspace area will be accepted.
    (d) Each person wishing to make a presentation will be asked to
note their intent when registering for the meeting so those time frames
can be established. This meeting will not be adjourned until everyone
registered to speak has had an opportunity to address the panel. This
meeting may be adjourned at any time if all persons present have had an
opportunity to speak.
    (e) Position papers or other handout material relating to the
substance of the meeting will be accepted. Participants submitting
papers or handout materials should send them to the mail or email
address noted in the COMMENTS section, above.
    (f) The meeting will be available on the FAA YouTube channel. A
summary of the comments made at the meeting will be filed in the
rulemaking docket.

    Information gathered through this meeting will assist the FAA in
drafting a notice of proposed rulemaking (NPRM) that would be published
in the Federal Register. The public will be afforded the opportunity to
comment on any NPRM published on this matter.
    A graphic depiction of the proposed airspace modifications may be
viewed at the following URL: www.faa.gov/air_traffic/community_engagement/sju.

Agenda for the Meeting

--Presentation of Meeting Procedures
--Informal Presentation of the Planned Class C Airspace Area
Modification
--Public Presentations
--Discussion and Questions
--Closing Comments

    Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

    Issued in Washington DC, on December 6, 2022.
Scott M. Rosenbloom,
Manager, Airspace Rules and Regulations.
[FR Doc. 2022-26910 Filed 12-9-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: July 16, 2009 (Volume 74, Number 135)]
[Proposed Rules]
[Page 34520-34522]
[DOCID:fr16jy09-10]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-0611; Directorate Identifier 2008-NM-165-AD]
RIN 2120-AA64

Airworthiness Directives; Construcciones Aeronauticas, S.A.
(CASA), Model C-212-CB, C-212-CC, C-212-CD, and C-212-CE Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

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

    Honeywell International, the manufacturer of the SPZ200
autopilot system installed on the EADS-CASA C-212 series aircraft,
has identified a series of servo-motors * * * designed for use in
the SPZ200 autopilot system, whose failure can lead to a potential
unsafe flight condition. * * *

* * * * *
The unsafe condition is failure of the servo-motors, which could result
in roll oscillations or possible hard-over failures when the autopilot
is engaged. The proposed AD would require actions that are intended to
address the unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by August 17, 2009.

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 W12-40, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
EADS-CASA, Military Transport Aircraft Division (MTAD), Integrated
Customer Services (ICS), Technical Services, Avenida de Arag[oacute]n
404, 28022 Madrid, Spain; telephone +34 91 585 55 84; fax +34 91 585 55
05; e-mail<EMAIL_ADDRESS>Internet http://
www.eads.net. You may review copies of the referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue, SW., Renton, Washington. For information on the availability of
this material at the FAA, call<PHONE_NUMBER> or<PHONE_NUMBER>.

Examining the AD Docket

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

FOR FURTHER INFORMATION CONTACT: Shahram Daneshmandi, Aerospace
Engineer, International Branch, ANM-116, Transport Airplane
Directorate, FAA, 1601 Lind Avenue, SW., Renton, Washington 98057-3356;
telephone<PHONE_NUMBER>; 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-2009-0611;
Directorate Identifier 2008-NM-165-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2008-0144, dated August 1, 2008 (referred to
after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:

    Honeywell International, the manufacturer of the SPZ200
autopilot system installed on the EADS-CASA C-212 series aircraft,
has identified a series of servo-motors, P/N [part number] 4006719-
904 and P/N 4006719-913, designed for use in the SPZ200 autopilot
system, whose failure can lead to a potential unsafe flight
condition. To address and correct this situation, Honeywell
International has published Alert Service Bulletin (ASB) 4006719-22-
A0016 (Revised) dated 1 November 2004, that identifies the affected
servo-motors by serial number, recommending the removal of these
units from the aircraft and including modification instructions to
be accomplished prior to reinstallation.
    EADS-CASA has determined that the flight safety of the C-212
aircraft is at risk. Consequently, Boletin de Servicio (Service
Bulletin) SB-212-22-16 has been published to advise C-212 operators
of this condition and to recommend that the affected servo-motors
are modified or replaced with modified units.
    For the reasons described above, this EASA AD requires the
identification of the affected servo-motors and modification or
replacement with modified units.

The unsafe condition is failure of the servo-motors, which could result
in roll oscillations or possible hard-over failures when the autopilot
is engaged. You may obtain further information by examining the MCAI in
the AD docket.

Relevant Service Information

    CASA has issued Service Bulletin SB-212-22-16, dated March 13,
2006. The actions described in this service information are intended to
correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Differences Between This AD and the MCAI or Service Information

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

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 26 products of U.S. registry. We also estimate that
it would take about 5 work-hours per product to comply with the basic
requirements of this proposed AD. The average labor rate is $80 per
work-hour. Based on these figures, we estimate the cost of the proposed
AD on U.S. operators to be $10,400, or $400 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 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.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

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

    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:

Construcciones Aeronauticas, S.A. (CASA): Docket No. FAA-2009-0611;
Directorate Identifier 2008-NM-165-AD.

Comments Due Date

    (a) We must receive comments by August 17, 2009.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to CASA Model C-212-CB, C-212-CC, C-212-CD
and C-212-CE airplanes, all serial numbers; certificated in any
category; on which autopilot servo-drive actuators (servo-motors)
having part number (P/N) 4006719-904 or 4006719-913 are installed.

Subject

    (d) Air Transport Association (ATA) of America Code 22: Auto
flight.

Reason

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

    Honeywell International, the manufacturer of the SPZ200
autopilot system installed on the EADS-CASA C-212 series aircraft,
has identified a series of servo-motors, P/N [part number] 4006719-
904 and P/N 4006719-913, designed for use in the SPZ200 autopilot
system, whose failure can lead to a potential unsafe flight
condition. To address and correct this situation, Honeywell
International has published Alert Service Bulletin (ASB) 4006719-22-
A0016 (Revised) dated 1 November 2004, that identifies the affected
servo-motors by serial number, recommending the removal of these
units from the aircraft and including modification instructions to
be accomplished prior to reinstallation.
    EADS-CASA has determined that the flight safety of the C-212
aircraft is at risk. Consequently, Boletin de Servicio (Service
Bulletin) SB-212-22-16 has been published to advise C-212 operators
of this condition and to recommend that the affected servo-motors
are modified or replaced with modified units.
    For the reasons described above, this EASA AD requires the
identification of the affected servo-motors and modification or
replacement with modified units.

The unsafe condition is failure of the servo-motors, which could
result in roll oscillations or possible hard-over failures when the
autopilot is engaged.

Actions and Compliance

    (f) Unless already done, do the following actions.
    (1) Within 2 months after the effective date of this AD:
Identify affected servo-motors having P/N 4006719-904 and P/N
4006719-913 and modify each unit or replace with a modified unit, in
accordance with the instructions of CASA Service Bulletin SB-212-22-
16, dated March 13, 2006.
    (2) As of the effective date of this AD, no person may install,
on any airplane, a servo-motor having P/N 4006719-904 or 4006719-
913, and any affected serial number identified in Honeywell Alert
Service Bulletin 4006719-22-A0016, dated November 1, 2004
(referenced in CASA Service Bulletin SB-212-22-16, dated March 13,
2006, as the source of service information for accomplishing the
modification), unless it has been modified in accordance with
paragraph (f)(1) of this AD.

    Note 1: The 8 digit serial number specified in Honeywell Service
Bulletin 4006719-22-A0016, dated November 1, 2004, is a combination
date code and serial number. The format is as follows: YYMMXXXX--YY
is the year; MM is the month, and XXXX is a sequential manufacturing
serial number (e.g., a unit with number 0111XXXX was manufactured in
November 2001).

FAA AD Differences

    Note 2: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. Send information to ATTN: Shahram Daneshmandi, Aerospace
Engineer, International Branch, ANM-116, Transport Airplane
Directorate, FAA, 1601 Lind Avenue, SW., Renton, Washington 98057-
3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Before using any
approved AMOC on any airplane to which the AMOC applies, notify your
principal maintenance inspector (PMI) or principal avionics
inspector (PAI), as appropriate, or lacking a principal inspector,
your local Flight Standards District Office.
    (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 ensure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act, the
Office of Management and Budget (OMB) has approved the information
collection requirements and has assigned OMB Control Number 2120-
0056.

Related Information

    (h) Refer to MCAI European Aviation Safety Agency Airworthiness
Directive 2008-0144, dated August 1, 2008, and CASA Service Bulletin
SB-212-22-16, dated March 13, 2006, for related information.

    Issued in Renton, Washington, on July 2, 2009.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E9-16941 Filed 7-15-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register: April 29, 2008 (Volume 73, Number 83)]
[Rules and Regulations]
[Page 23101-23103]
[DOCID:fr29ap08-7]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2007-1188; FRL-8559-5]

Approval and Promulgation of Air Quality Implementation Plans;
Delaware; Control of Stationary Generator Emissions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is approving a State Implementation Plan (SIP) revision
submitted by the State of Delaware. This SIP revision contains
provisions to control emissions from stationary generators. EPA is
approving this SIP revision in accordance with the Clean Air Act (CAA).

DATES: Effective Date: This final rule is effective on May 29, 2008.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2007-1188. All documents in the docket are listed in
the http://www.regulations.gov Web site. Although listed in the
electronic docket, some information is not publicly

available, i.e., confidential business information (CBI) 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
http://www.regulations.gov or in hard copy for public inspection during
normal business hours at the Air Protection Division, U.S.
Environmental Protection Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103. Copies of the State submittal are
available at the Delaware Department of Natural Resources &
Environmental Control, 89 Kings Highway, P.O. Box 1401, Dover, Delaware
19903.

FOR FURTHER INFORMATION CONTACT: Rose Quinto,<PHONE_NUMBER>, or by e-
mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On March 5, 2008 (73 FR 11845), EPA published a notice of proposed
rulemaking (NPR) for the State of Delaware. The NPR proposed approval
of the provisions to control emissions from stationary generators. The
formal SIP revision was submitted by the State of Delaware on November
1, 2007. Specific requirements of Delaware's regulation to control
emissions from stationary generators and the rationale for EPA's
proposed action are explained in the NPR and will not be restated here.
No public comments were received on the NPR.

II. Final Action

    EPA is approving Regulation No. 1144--Control of Stationary
Generator Emissions, as a revision to the Delaware SIP. This regulation
will help ensure that the air emissions from new and existing
generators do not cause or contribute to the existing air quality
problems with regard to ground-level ozone and fine particulate matter,
thereby adversely impacting public health, safety, and welfare.

III. Statutory and Executive Order Reviews

A. General Requirements

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

B. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by June 30, 2008. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this rule for the purposes of judicial review nor does
it extend the time within which a petition for judicial review may be
filed, and shall not postpone the effectiveness of such rule or action.
This action, pertaining to Delaware's regulation to control emissions
from stationary generators, may not be challenged later in proceedings
to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Nitrogen dioxide, Ozone, Particulate
matter, Reporting and recordkeeping requirements, Sulfur oxides.

    Dated: April 15, 2008.
William T. Wisniewski,
Acting Regional Administrator, Region III.
    40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

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

Subpart I--Delaware

0
2. In Sec.  52.420, the table in paragraph (c) is amended by adding
entries for Regulation No. 1144--Control of Stationary Generators
Emissions at the end of the table to read as follows:

Sec.  52.420  Identification of plan.

* * * * *
    (c) * * *

                                  EPA-Approved Regulations in the Delaware SIP
----------------------------------------------------------------------------------------------------------------
                                                State
      State citation         Title/subject    effective        EPA approval date        Additional explanation
                                                 date
----------------------------------------------------------------------------------------------------------------

                                                 * * * * * * *
                          Regulation No. 1144 Control of Stationary Generator Emissions
----------------------------------------------------------------------------------------------------------------
Section 1.0...............  General........     01/11/06  4/29/08 [Insert page
                                                           number where the document
                                                           begins].
Section 2.0...............  Definitions....     01/11/06  4/29/08 [Insert page
                                                           number where the document
                                                           begins].
Section 3.0...............  Emissions......     01/11/06  4/29/08 [Insert page
                                                           number where the document
                                                           begins].
Section 4.0...............  Operating           01/11/06  4/29/08 [Insert page
                             Requirements.                 number where the document
                                                           begins].
Section 5.0...............  Fuel                01/11/06  4/29/08 [Insert page
                             Requirements.                 number where the document
                                                           begins].
Section 6.0...............  Record Keeping      01/11/06  4/29/08 [Insert page
                             and Reporting.                number where the document
                                                           begins].
Section 7.0...............  Emissions           01/11/06  4/29/08 [Insert page
                             Certification,                number where the document
                             Compliance,                   begins].
                             and
                             Enforcement.
Section 8.0...............  Credit for          01/11/06  4/29/08 [Insert page
                             Concurrent                    number where the document
                             Emissions                     begins].
                             Reductions.
Section 9.0...............  DVFA Member         01/11/06  4/29/08 [Insert page
                             Companies.                    number where the document
                                                           begins].
----------------------------------------------------------------------------------------------------------------

* * * * *
 [FR Doc. E8-9262 Filed 4-28-08; 8:45 am]

BILLING CODE 6560-50-P


MEMORANDUM

DATE:		September 16, 2014

TO:		Carbon Power Plan for Existing Power Plants; Docket Id: OAR - 2013-0602

FROM:	Gavin Lau, EPA Region 2/CASD-APB

SUBJECT:	July 16, 2014 Meeting Regarding Proposed Carbon Power Plan for Existing Power Plants
--------------------------------------------------------------------------------

SUMMARY

      A meeting was held between EPA and the attendees listed below on July 16, 2014 to discuss the proposed Carbon Power Plan for Existing Power Plants. The Carbon Power Plan for Existing Power Plants was proposed on June 2, 2014.

ATTENDEES

New Jersey Department of Environmental Protection:

Mr. William O'Sullivan, Director, Division of Air Quality
Mr. Robert Marshall, Assistant Commissioner, Sustainability and Green Energy
Mr. Kenneth Frank
Ms. Sarah Gentile
Mr. John Gorgol
Mr. Michael Hogan
Mr. Steven Jenks

New Jersey Board of Public Utilities:

Ms. Anne Marie McShea
Mr. Michael Winka

Questions Submitted for July 16, 2014 call

Attachment 1
NJ question/discussion topics regarding Clean Power Plan Proposal.
Set #1
From Email WOS-NJDEP to John F.  - EPA 6/5 7:53 PM
Questions
   * How is performance determined with the numerical emission goals set for 2020 and 2030?
   * The logical  compliance determination method is to sum up all the CO2 emitted from all the power plants in a state in a year and then divide by the sum of all the MWhrs of electricity produced in that state in the same year.   Is there a different formula in the proposal?
   * Are there any adjustments to this basic equation to determine performance, and if so, where in EPA proposal documents can this be found?
   * One logical adjustment is to give a state credit for renewables funded in another state.  Does the proposal address that circumstance?
   * For a nuclear power plant that is scheduled to shut down before 2020, because of adverse environmental impacts, does EPA assume continued operation in 2020 and 2030, in setting a state's goals?  If so, why?
   * For states with few coal EGUs and much combined cycle gas EGUs does EPA's goal setting procedure assume there will be no coal use in 2020 or 2030, if the coal provided electricity can be provided by the combined cycle gas units?  Might this result in some states having no coal and all the coal use further concentrating in the states with the most coal use now?
   * For coal units, did EPA determine which units already have been rebuilt and/or modified to improve efficiency?  Or was the 6% efficiency improvement assumption made for all coal units, regardless of age and current efficiency?
   * Why do states that have already reduced GHG emissions substantially have greater % reduction goals than states that have made little progress?
   * If State 1 installed 20% renewables before 2012, does this generate credits to meet the performance goal?  If state 2, with no renewables today, installs 20% renewables after 2012, does this generate credit towards the goal?  If the amount of credits are different, why?
   * Is NJ limited to the facilities that EPA used to derive NJ's proposed goal in calculating whether goals are met?
Set #2
From Email WOS-NJDEP to John F.  - EPA 6/12 2:05 PM
John - I missed some of the EPA calls to answer questions, so don't know which of these have been answered already.  Any specific feedback on these?   [This question references set #1 questions above, actual question next paragraph-GL]
I did get an opportunity to ask a question on the ECOS call last week, which Joe G answered.   My question was whether a state can include other EGU's in the calculation of whether the goal is met, or whether we were limited to the 21 facilities in NJ that EPA used to derive the NJ proposed goal.    Joe explained that other EGUs can and should be included in the compliance determination.  That is what I expected, but I'm still unclear as to whether EPA expects to limit what units a state can include in the compliance calculation.   I believe that the proposed rule text enables states to have the flexibility to include all their EGUs, for both CO2 emissions and MWhrs, in determining conformity with the goal, but the preamble language is unclear in this regard.  I'd like clarification that states can include all it's EGUs, and are not limited to including only certain EGUs in the numerator and denominator, when calculating lb CO2/MWhr.  (My thought is EPA should encourage this, for various reasons, and need to know whether EPA's intent is different, so we can determine if this is an area we should focus on in our comments.)
Set #3
From Email WOS-NJDEP to John F.  - EPA 6/18 4:21 PM
AA Janet said EPA staff could sit down with each state and review in detail how their goals were derived.   We would like to do that for NJ, perhaps in mid-July.  We understand in general the intent of the building blocks and goal calculation.  We want to review the technical detail for each EGU included.   Also, we want to discuss the consequences of at least the following EPA assumptions in calculating NJ goal.  We will refine, correct and supplement this list as we learn more.   Please let me know when would be good for meeting with EPA experts.

1.     Assumption - Nucs can be uprated after 2012
Start of discussion - NJ nucs (except Oyster Creek) were uprated about 2008.   This is a baseline issue.  EPA's stated flexibility to use 2005 as baseline where justified might address.
2.       Assumption - Oyster Creek is an at risk nuc, which can have its shutdown date extended.
Start of Discussion - Oyster Creek in NJ is the oldest nuclear plant in the nation.   There is a consent decree to shut down in 2019, because of thermal impacts on Barnegat Bay.  Consequently, the NJ goal should be adjusted to delete a presumed lifecycle extension for this nuc.
3.      Assumption - All coal and oil use in NJ can be replaced by increased use of natural gas.
Start of Discussion - Does the NJ goal actually assume this?  Is there a minimum percentage of coal capacity that the EPA building block does not convert to CC gas?     Does conversion of coal and oil to CC gas consider annual or daily capacity needs?  Annual capacity calculations miss daily needs.  For example, oil and coal units are needed during the cold winter days, to keep the lights on when gas is being used to heat homes.   Also, 4 coal plants have billions in modern air pollution control and already meet MAT and NOx RACT.    These are the type of coal units which should continue to operate for their useful life, not units without good NOx control.   Coal use at 2 small NJ plants did cease in 2010, because of NJ's criteria pollutant requirements.   A change in baseline date would provide credit for these.
4.      Assumption  -  All coal units can achieve a 6% increase in heat rate.
Start of Discussion -   4 NJ coal fired power plants (6 units) are relatively new or rebuilt.  For these 6 units have they already undergone energy efficiency improvement?   Is there any further ee improvement reasonably feasible?  Can the NJ goal be adjusted to reflect the actual ee feasible, rather than the assumed 6% improvement in heat rate?
5.      Assumption - A significant amount of existing gas fired "affected units" in NJ can be replaced with nuclear, energy efficiency or RE?
Start of Discussion - Given the difficulties of 1, 2, 3, and 4; the NJ goal if not adjusted might this result in the shutdown of some existing combined cycle units in NJ.   Can the goal not include combined cycle units, especially those that meet 111(b).  Our NOx rules will result in the shutdown of about 3700 MW of gas and oil peakers in 2015, which are not "affected units".  How can we get credit for the CO2 reductions?  (not large because these are peakers)
6.       Comparison  -  NJ with Kentucky.  Does Kentucky get credit for new CC gas and NJ does not?   Are the surviving Kentucky coal plants less efficient than the at risk, and probably better controlled for criteria pollutants, NJ coal plants?

Set #4
From Email B. Marshall-NJ to G. Lau-EPA 7/14 5:46 PM
Please explain the mutual benefits or disadvantages that might be realized if a multi-state approach were taken by NJ and select states within the PJM region.  For example, what specific advantages and disadvantages might be realized for NJ, Pennsylvania, Delaware, Illinois, Indiana, Kentucky, Maryland, Michigan, North Carolina, Ohio, Tennessee, Virginia, West Virginia and the District of Columbia to have a common plan for the entire PJM electric grid?


[Federal Register Volume 88, Number 55 (Wednesday, March 22, 2023)]
[Notices]
[Pages 17213-17214]
[FR Doc No: 2023-05890]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP22-43-000]

Texas Eastern Transmission, LP; Notice of Request for Extension
of Time

    Take notice that on March 7, 2023, Texas Eastern Transmission, LP
(Texas Eastern) requested that Federal Energy Regulatory Commission
(Commission) grant an extension of time, until April 7, 2024, to
complete its Gator Express Meter Station Project (Project). Texas
Eastern received a prior notice authorization for the Project on
February 7, 2022, which authorized: Texas Eastern to construct and
operate interconnection facilities between Texas Eastern and Venture
Global Gator Express, LLC (Gator Express) in Plaquemines Parish,
Louisiana. Specifically, Texas Eastern proposed to construct a new
metering and regulating facilities (M&R Facilities) which will be
installed on a platform owned by Gator Express with approximately 0.2
mile of 30-inch-diameter interconnecting piping and a riser to connect
Texas Eastern's Line to M&R Facilities on the Gator Express platform.
The Commission's prior notice regulations require Texas Eastern to
complete the construction of the Project and make it available for
service within one year from issuance, or by April 8, 2023.\1\
---------------------------------------------------------------------------

    \1\ 18 CFR 157.207(c).
---------------------------------------------------------------------------

    In Texas Eastern's request for an extension of time, Texas Eastern
stated that during construction Gator Express was unable to provide
Texas Eastern with access to the platform, as Gator Express experienced
its own extenuating circumstances that caused its delay in constructing
the platform, including severe weather. Due to the extenuating
circumstances Texas Eastern requests an extension of time which to
complete the Project from the one-year date of April 8, 2023, to the
new projected completion date of April 8, 2024.
    This notice establishes a 15-calendar day intervention and comment
period deadline. Any person wishing to comment on SNG's request for an
extension of time may do so. No reply comments or answers will be
considered. If you wish to obtain legal status by becoming a party to
the proceedings for this request, you should, on or before the comment
date stated below, file a motion to intervene in accordance with the
requirements of the Commission's Rules of Practice and Procedure (18
CFR 385.214 or 385.211) and the Regulations under the Natural Gas Act
(18 CFR 157.10).\2\
---------------------------------------------------------------------------

    \2\ Only motions to intervene from entities that were party to
the underlying proceeding will be accepted. Algonquin Gas
Transmission, LLC, 170 FERC ] 61,144, at P 39 (2020).
---------------------------------------------------------------------------

    As a matter of practice, the Commission itself generally acts on
requests for extensions of time to complete construction for Natural
Gas Act facilities when such requests are contested before order
issuance. For those extension requests that are contested,\3\ the
Commission will aim to issue an order acting on the request within 45
days.\4\ The Commission will address all arguments relating to whether
the applicant has demonstrated there is good cause to grant the
extension.\5\ The Commission will not consider arguments that re-
litigate the issuance of the Certificate Order, including whether the
Commission properly found the project to be in the public convenience
and necessity and whether the Commission's environmental analysis for
the certificate complied with the National Environmental Policy Act.\6\
At the time

a pipeline requests an extension of time, orders on certificates of
public convenience and necessity are final and the Commission will not
re-litigate their issuance.\7\ The OEP Director, or his or her
designee, will act on those extension requests that are uncontested.
---------------------------------------------------------------------------

    \3\ Contested proceedings are those where an intervenor disputes
any material issue of the filing. 18 CFR 385.2201(c)(1) (2020).
    \4\ Algonquin Gas Transmission, LLC, 170 FERC ] 61,144, at P 40
(2020).
    \5\ Id. P 40.
    \6\ Similarly, the Commission will not re-litigate the issuance
of an NGA section 3 authorization, including whether a proposed
project is not inconsistent with the public interest and whether the
Commission's environmental analysis for the permit order complied
with NEPA.
    \7\ Algonquin Gas Transmission, LLC, 170 FERC ] 61,144, at P 40
(2020).
---------------------------------------------------------------------------

    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning COVID-19, issued by the President on March 13, 2020. For
assistance, contact FERC at [email protected] or call toll-
free,<PHONE_NUMBER> or TTY,<PHONE_NUMBER>.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFile'' link at
http://www.ferc.gov. Persons unable to file electronically should
submit an original copy of the protest or intervention by U.S. mail to
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street NE, Room 1A, Washington, DC 20426. Submissions by any
other courier in docketed proceedings should be delivered to, Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852.
    Comment Date: 5:00 p.m. Eastern Time on March 31, 2023.

    Dated: March 16, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-05890 Filed 3-21-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: May 5, 2006 (Volume 71, Number 87)]
[Notices]
[Page 26572-26573]
[DOCID:fr05my06-136]

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

SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon written request, copies available from: Securities and Exchange
Commission, Office of Filings and Information Services, Washington, DC
20549.

Extension: Rule 489 and Form F-N; SEC File No. 270-361; OMB Control
No. 3235-0411.

    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 these
existing collections of information to the Office of Management and
Budget for extension and approval:
     Rule 489 (17 CFR 230.489) under the Securities Act of 1933
(15 U.S.C. 77a

et seq.), Filing of Form by Foreign Banks and Insurance Companies and
Certain of Their Holding Companies and Finance Subsidiaries; and Form
F-N (17 CFR 239.43), Appointment of Agent for Service of Process by
Foreign Banks and Foreign Insurance Companies and Certain of Their
Holding Companies and Finance Subsidiaries Making Public Offerings of
Securities in the United States.
    Rule 489 (17 CFR 230.489) under the Securities Act of 1933 (15
U.S.C. 77a et seq.) requires foreign banks and foreign insurance
companies and holding companies and finance subsidiaries of foreign
banks and foreign insurance companies that are exempted from the
definition of ``investment company'' by virtue of Rules 3a-1, 3a-5, and
3a-6 under the Investment Company Act of 1940 (15 U.S.C. 80a-1 et seq.)
to file Form F-N under the Securities Act of 1933 to appoint an agent
for service of process when making a public offering of securities in
the United States. Approximately seven entities are required by Rule
489 to file Form F-N, which is estimated to require an average of one
hour to complete. The estimated annual burden of complying with the
rule's filing requirement is approximately eleven hours, as some of the
entities submitted multiple filings.
    The estimates of average burden hours are made solely for the
purposes of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et
seq.) and are not derived from a comprehensive or even representative
survey or study of the cost of Commission rules and forms.
    Written comments are invited on: (a) Whether the proposed
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 of the collection 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.
    Please direct your written comments to R. Corey Booth, Director/
Chief Information Officer, Securities and Exchange Commission, C/O
Shirley Martinson, 6432 General Green Way, Alexandria, Virginia 22312,
or send an e-mail to<EMAIL_ADDRESS>
    April 25, 2006.
Nancy M. Morris,
Secretary.
[FR Doc. E6-6779 Filed 5-4-06; 8:45 am]

BILLING CODE 8010-01-P