[Federal Register Volume 88, Number 29 (Monday, February 13, 2023)]
[Notices]
[Page 9311]
[FR Doc No: 2023-03096]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

TIME AND DATE: 2:00 p.m. on Thursday, February 16, 2023.

PLACE: The meeting will be held via remote means and/or at the
Commission's headquarters, 100 F Street NE, Washington, DC 20549.

STATUS: This meeting will be closed to the public.

MATTERS TO BE CONSIDERED: Commissioners, Counsel to the Commissioners,
the Secretary to the Commission, and recording secretaries will attend
the closed meeting. Certain staff members who have an interest in the
matters also may be present.
    In the event that the time, date, or location of this meeting
changes, an announcement of the change, along with the new time, date,
and/or place of the meeting will be posted on the Commission's website
at https://www.sec.gov.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (6), (7), (8), 9(B) and (10) and 17 CFR
200.402(a)(3), (a)(5), (a)(6), (a)(7), (a)(8), (a)(9)(ii) and (a)(10),
permit consideration of the scheduled matters at the closed meeting.
    The subject matter of the closed meeting will consist of the
following topics:
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings;
    Resolution of litigation claims; and
    Other matters relating to examinations and enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting agenda items that may consist of
adjudicatory, examination, litigation, or regulatory matters.

CONTACT PERSON FOR MORE INFORMATION: For further information; please
contact Vanessa A. Countryman from the Office of the Secretary at (202)
551-5400.
    Authority: 5 U.S.C. 552b.

    Dated: February 9, 2023.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2023-03096 Filed 2-9-23; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 134 (Friday, July 12, 2019)]
[Notices]
[Pages 33267-33268]
[FR Doc No: 2019-14856]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-2398]

Population Pharmacokinetics; Revised Draft Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a revised draft guidance for industry entitled
``Population Pharmacokinetics.'' This revised draft guidance assists
sponsors in the application of population pharmacokinetics (population
PK) during the drug development process to inform drug use and includes
FDA's current thinking on the data and model requirements for
population PK analyses submitted as part of new drug applications
(NDAs) and biologic license applications (BLAs). The revised draft
guidance also provides expectations regarding the format and content of
the population PK report as well as any labeling recommendations
resulting from such analyses.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 10, 2019.

ADDRESSES: You may submit comments 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 2019-D-2398 for ``Population Pharmacokinetics.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked

as ``confidential'' will not be disclosed except in accordance with 21
CFR 10.20 and other applicable disclosure law. For more information
about FDA's posting of comments to public dockets, see 80 FR 56469,
September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the 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 to 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. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Hao Zhu, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 3132, Silver Spring, MD 20993,<PHONE_NUMBER> 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,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised draft guidance for
industry entitled ``Population Pharmacokinetics.'' Population PK
analyses can quantify the impact of intrinsic and extrinsic patient
factors on the exposure of a drug. In conjunction with supporting
exposure-response data, population PK data can be used to identify
patient factors that result in a clinically significant change in drug
exposure and inform the proper use of drugs. Since FDA announced the
publication of the original population PK guidance in 1999, the number
of applications relevant for population PK analysis has increased, and
the sophistication and reliability of population PK analysis methods
have improved. This revised draft guidance will replace the 1999 FDA
guidance for industry of the same name.
    This revised draft guidance assists sponsors of NDAs and BLAs in
the conduct of population PK analysis. Specifically, the revised draft
guidance includes a description of the types of scientific and
regulatory questions appropriate for population PK analysis and
outlines FDA's recommendations for data analysis and modeling.
Recommendations on the format and content of population PK reports
submitted to FDA as well as any labeling statements informed by the
results of these analyses are also provided.
    This revised 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
``Population Pharmacokinetics.'' It does not establish any rights for
any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations. This guidance is not subject to Executive
Order 12866.

II. Paperwork Reduction Act of 1995

    This revised draft guidance refers to previously approved
collections of information 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 collections of information in 21 CFR parts
312 and 314 have been approved under OMB control numbers 0910-0014 and
0910-0001, respectively. The collection of information in 21 CFR 201.56
and 201.57 has been approved under OMB control number 0910-0572.

III. Electronic Access

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

    Dated: July 8, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-14856 Filed 7-11-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 119 (Wednesday, June 20, 2012)]
[Proposed Rules]
[Pages 36948-36950]
[FR Doc No: 2012-15063]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 77, No. 119 / Wednesday, June 20, 2012 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0639; Directorate Identifier 2012-NM-005-AD]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc. 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 all
Bombardier, Inc. Model CL-600-2B19 (Regional Jet Series 100 & 440)
airplanes. This proposed AD was prompted by a report that the safe life
limit and inspection requirements for the horizontal stabilizer trim
actuator (HSTA) attachment pins and trunnions were not listed in the
Airworthiness Limitations Section of the maintenance program. This
proposed AD would require inspecting the trunnions and upper and lower
pins for gouges, scratches, and corrosion, and replacing if necessary;
and adding serial numbers and new part numbers to certain trunnions,
and upper and lower pins. This proposed AD would also require revising
the maintenance program to incorporate the information specified in
certain temporary revisions of the limitations section. We are
proposing this AD to detect and correct cracking, gouges, scratches,
and corrosion of the HSTA attachment pins and trunnions, which could
result in failure of these pins and trunnions and consequent
disconnection of the horizontal stabilizer and subsequent loss of
controllability of the airplane.

DATES: We must receive comments on this proposed AD by August 6, 2012.

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, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval, Qu[eacute]bec
H4S 1Y9, Canada; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>Internet http://www.bombardier.com. 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>.

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: Cesar Gomez, Aerospace Engineer,
Airframe and Mechanical Systems Branch, ANE-171, FAA, New York Aircraft
Certification Office, 1600 Stewart Avenue, Suite 410, Westbury, New
York 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

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-2012-0639;
Directorate Identifier 2012-NM-005-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

    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian Airworthiness Directive CF-
2011-45, dated December 19, 2011 (referred to after this as ``the
MCAI''), to correct an unsafe condition for the specified products. The
MCAI states:

    During a review of the Horizontal Stabilizer Trim Actuator
(HSTA) system, it was discovered that the safe life limits and the
inspection requirements for the HSTA attachment pins and trunnions
were not listed in the Airworthiness Limitations Section of the
Instructions for Continued Airworthiness. Also, the HSTA attachment
pins and trunnions were not serialized making it impossible to keep
accurate records of the life of these parts. Failure of these pins
and trunnions will lead to a disconnect of the horizontal stabilizer
and subsequent loss of the aeroplane.
    This [TCCA] Airworthiness Directive (AD) mandates the
serialization of the HSTA attachment pins and trunnions.

    The required actions include a detailed inspection of the trunnions
and upper and lower pins for gouges, scratches, and corrosion, and
replacing if necessary; and adding serial numbers and new part numbers
to certain trunnions, and upper and lower pins. This proposed AD would
also require revising the maintenance program to incorporate the
information specified in certain temporary revisions of the limitations
section. You may obtain further information by examining the MCAI in
the AD docket.

Relevant Service Information

    Bombardier, Inc. has issued the following service information. The
actions described in this service information are intended to correct
the unsafe condition identified in the MCAI.

     Bombardier Service Bulletin 601R-27-160, dated September
29, 2011.
     Bombardier Temporary Revision 2B-2180, dated August 8,
2011, to Appendix B--Airworthiness Limitations, of Part 2,
Airworthiness Requirements, of the Bombardier CL-600-2B19 Maintenance
Requirements Manual.
     Bombardier Temporary Revision 2B-2186, dated August 8,
2011, to Appendix B--Airworthiness Limitations, of Part 2,
Airworthiness Requirements, of the Bombardier CL-600-2B19 Maintenance
Requirements Manual.

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.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 586 products of U.S. registry. We also estimate that
it would take about 20 work-hours per product to comply with the basic
requirements of this proposed AD. The average labor rate is $85 per
work-hour. Required parts would cost about $162 per product. Where the
service information lists required parts costs that are covered under
warranty, we have assumed that there will be no charge for these parts.
As we do not control warranty coverage for affected parties, some
parties may incur costs higher than estimated here. Based on these
figures, we estimate the cost of the proposed AD on U.S. operators to
be $1,091,132, or $1,862 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 20 work-hours and require parts costing $4,391, for a cost
of $6,091 per product. We have no way of determining the number of
products that may need these actions.

Authority for This Rulemaking

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

Regulatory Findings

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

Bombardier, Inc.: Docket No. FAA-2012-0639; Directorate Identifier
2012-NM-005-AD.

(a) Comments Due Date

    We must receive comments by August 6, 2012.

(b) Affected ADs

    None.

(c) Applicability

    (1) This AD applies to Bombardier, Inc. Model CL-600-2B19
(Regional Jet Series 100 & 440) airplanes, certificated in any
category, all serial numbers.
    (2) This AD requires revisions to certain operator maintenance
documents to include new actions (e.g., inspections) and/or Critical
Design Configuration Control Limitations (CDCCLs). Compliance with
these actions and/or CDCCLs is required by 14 CFR 91.403(c). For
airplanes that have been previously modified, altered, or repaired
in the areas addressed by this AD, the operator may not be able to
accomplish the actions described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must
request approval for an alternative method of compliance according
to paragraph (l)(1) of this AD. The request should include a
description of changes to the required actions that will ensure the
continued operational safety of the airplane.

(d) Subject

    Air Transport Association (ATA) of America Code 27: Flight
controls.

(e) Reason

    This AD was prompted by a report that the safe life limit and
inspection requirements for the horizontal stabilizer trim actuator
(HSTA) attachment pins and trunnions were not listed in the
Airworthiness Limitations Section of the maintenance program. We are
issuing this AD to detect and correct cracking, gouges, scratches,
and corrosion of the HSTA attachment pins and trunnions, which could
result in failure of these pins and trunnions and consequent
disconnection of the horizontal stabilizer and subsequent loss of
controllability of the airplane.

(f) Compliance

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

(g) Inspection

    At the earliest of the times specified in paragraphs (g)(1),
(g)(2), and (g)(3) of this AD: Do a detailed inspection of the
trunnions, upper pins, and lower pins identified in table 1 of this
AD, for gouges, scratches, and corrosion, in accordance with the
Accomplishment Instructions of Bombardier Service Bulletin 601R-27-
160, dated September 29, 2011.
    (1) Within 5,000 flight hours after the effective date of this
AD.
    (2) Within 60 months after the effective date of this AD.
    (3) Before the accumulation of 40,000 total flight cycles, or
within 60 days after the effective date of this AD, whichever occurs
later.

                         Table 1--Affected Parts
------------------------------------------------------------------------
                      Part name                             Part No.
------------------------------------------------------------------------
Upper Pin............................................        600-92384-5
Upper Pin............................................        600-92384-7
Upper Pin............................................        601R92310-1
Lower Pin............................................        600-92383-5
Lower Pin............................................        600-92383-7
Lower Pin............................................        601R92309-1
Trunnion.............................................        601R92386-1
------------------------------------------------------------------------

(h) Replacement

    If, during any inspection required by paragraph (g) of this AD,
any gouges, scratches, or corrosion are found: Before further
flight, replace the affected part with a part other than one
identified in table 1 of this AD, in accordance with the
Accomplishment Instructions of Bombardier Service Bulletin 601R-27-
160, dated September 29, 2011.

(i) Re-Identification

    If, during any inspection required by paragraph (g) of this AD,
no gouges, scratches or corrosion are found: Before further flight,
add serial numbers and new part numbers to the trunnions, upper
pins, and lower pins, in accordance with the Accomplishment
Instructions of Bombardier Service Bulletin 601R-27-160, dated
September 29, 2011.

(j) Revise Maintenance Program

    Within 30 days after the effective date of this AD, revise the
maintenance program to incorporate the information specified in
Bombardier Temporary Revisions 2B-2180, dated August 8, 2011; and
2B-2186, dated August 8, 2011; to Appendix B--Airworthiness
Limitations, of Part 2, Airworthiness Requirements, of the
Bombardier CL-600-2B19 Maintenance Requirements Manual (MRM). The
compliance time for doing the initial replacement for the HSTA
trunnion support and attaching hardware is before the accumulation
of 80,000 landings or within 60 days after the effective date of
this AD, whichever occurs later. The compliance time for doing the
initial inspection of the upper and lower installation pins of the
horizontal stabilizer pitch trim actuator is before the accumulation
of 40,000 landings or within 60 days after the effective date of
this AD, whichever occurs later.

(k) No Alternative Actions or Intervals

    After accomplishing the revision required by paragraph (j) of
this AD, no alternative actions (e.g., inspections) or intervals may
be used unless the actions or intervals are approved as an
alternative method of compliance (AMOC) in accordance with the
procedures specified in paragraph (l)(1) of this AD.

(l) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office, ANE-170, FAA, has the authority
to approve AMOCs for this AD, if requested using the procedures
found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your
request to your principal inspector or local Flight Standards
District Office, as appropriate. If sending information directly to
the ACO, send it to ATTN: Program Manager, Continuing Operational
Safety, FAA, New York ACO, 1600 Stewart Avenue, Suite 410, Westbury,
New York 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Before
using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
local flight standards district office/certificate holding district
office. The AMOC approval letter must specifically reference this
AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(m) Related Information

    (1) Refer to MCAI Canadian Airworthiness Directive CF-2011-45,
dated December 19, 2011, and the service information specified in
paragraphs (m)(1)(i), (m)(1)(ii), and (m)(1)(iii) of this AD, for
related information.
    (i) Bombardier Service Bulletin 601R-27-160, dated September 29,
2011.
    (ii) Bombardier Temporary Revision 2B-2180, dated August 8,
2011, to Appendix B--Airworthiness Limitations, of Part 2,
Airworthiness Requirements, of the Bombardier CL-600-2B19
Maintenance Requirements Manual.
    (iii) Bombardier Temporary Revision 2B-2186, dated August 8,
2011, to Appendix B--Airworthiness Limitations, of Part 2,
Airworthiness Requirements, of the Bombardier CL-600-2B19
Maintenance Requirements Manual.
    (2) For service information identified in this AD, contact
Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval,
Qu[eacute]bec H4S 1Y9, Canada; telephone<PHONE_NUMBER>; fax 514-855-
7401; email<EMAIL_ADDRESS>Internet http://www.bombardier.com. 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>.

    Issued in Renton, Washington, on June 11, 2012.
Kalene C. Yanamura,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-15063 Filed 6-19-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: October 28, 2005 (Volume 70, Number 208)]
[Notices]
[Page 62127-62128]
[DOCID:fr28oc05-53]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

Agency Information Collection Activities: Proposed Collection;
Comment Request

AGENCY: Federal Emergency Management Agency, Emergency Preparedness and
Response Directorate, U.S. Department of Homeland Security.

ACTION: Notice and request for comments.

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

SUMMARY: The Federal Emergency Management Agency, as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public and other Federal agencies to take this opportunity
to comment on a proposed continuing information collection. In
accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3506(c)(2)(A)), this notice seeks comments on the Exemption of State-
Owned Properties Under Self-Insurance Plan.

SUPPLEMENTARY INFORMATION: 44 CFR part 75 establishes standards with
respect to the Federal Insurance Administrator's (FIA) determinations,
that a State's plan of self-insurance is adequate and satisfactory for
the purposes of the Act, from the requirement of purchasing flood
insurance coverage for State-owned structures and their contents in
areas identified by the Administrator as A, AO, AH, A1-A30, AE, A99, M,
V, VO, V1-V30 and E zones, in which the sale of insurance has been made
available. It also establishes the procedures by

which a State may request exemption under Section 102 C of the Act.

Collection of Information

    Title: Exemption of State-Owned Properties Under Self-Insurance
Plan.
    Type of Information Collection: Extension of a currently approved
collection.
    OMB Number: 1660-0013.
    Form Numbers: None.
    Abstract: The application for exemption is made to the Federal
Insurance Administration by the Governor or other duly authorized
official of the State accompanied by sufficient supporting
documentation which certifies that the plan of self-insurance upon
which the application for exemption is based meets or exceeds the
standards set forth in 44 CFR section 75.11. Upon determining that the
State's plan of self-insurance equals or exceeds the standards, the
Administrator then certifies that the State is exempt from the
requirements for the purchase of flood insurance for State-owned
structures and their contents.
    Affected Public: Individuals or households; Business or other for-
profit; Not-for-profit institutions; Farms; Federal Government: State,
Local or Tribal Government.
    Estimated Total Annual Burden Hours: 100.

----------------------------------------------------------------------------------------------------------------
                                      No. of       Frequency of    Burden hours       Annual       Total annual
           FEMA forms               respondents      response      per response      responses     burden hours
                                             (A)             (B)             (C)           (AxB)         (AxBxC)
---------------------------------
Letter application..............              20               1               5              20             100
---------------------------------
    Total.......................              20               1               5              20             100
----------------------------------------------------------------------------------------------------------------

    Estimated Cost: Combined cost all respondents is $15,500 or $155.00
per respondent.

Comments

    Written comments are solicited to (a) evaluate whether the proposed
data collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.
Comments should be received within 60 days of the date of this notice.

ADDRESSES: Interested persons should submit written comments to Chief,
Records Management Section, Information Resources Management Branch,
Information Technology Services Division, Federal Emergency Management
Agency, Emergency Preparedness and Response Directorate, Department of
Homeland Security, 500 C Street, SW., Room 316, Washington, DC 20472.

FOR FURTHER INFORMATION CONTACT: You may contact Ms. Mary Ann Chang,
Insurance Examiner, Federal Insurance Administration,<PHONE_NUMBER>.
For copies of the proposed collection of information contact the
Records Management Section at<PHONE_NUMBER> or e-mail address:
<EMAIL_ADDRESS>

    Dated: October 20, 2005.
George S. Trotter,
Acting Branch Chief, Information Resources Management Branch,
Information Technology Services Division.
[FR Doc. 05-21508 Filed 10-27-05; 8:45 am]

BILLING CODE 9110-11-P