[Federal Register Volume 80, Number 147 (Friday, July 31, 2015)]
[Notices]
[Pages 45660-45661]
[FR Doc No: 2015-18796]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0309]

International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products;
Bracketing and Matrixing Designs for Stability Testing of New
Veterinary Drug Substances and Medicinal Products; Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry (GFI) #198 entitled
``Bracketing and Matrixing Designs for Stability Testing of New
Veterinary Drug Substances and Medicinal Products'' (VICH GL45). This
guidance has been developed for veterinary use by the International
Cooperation on Harmonisation of Technical Requirements for Registration
of Veterinary Medicinal Products (VICH). This VICH guidance is an annex
to a VICH guidance GFI #73 entitled ``Stability Testing of New
Veterinary Drug Substances and Medicinal Products (Revision)'' VICH
GL3(R). This VICH guidance document is intended to provide guidance on
the application of reduced designs (i.e., bracketing and matrixing) for
stability studies conducted in accordance with the principles outlined
in VICH GL3(R).

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of this guidance
to the Policy and Regulations Staff (HFV-6), Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville,
MD 20855. Send one self-addressed adhesive label to assist that office
in processing your request. See the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Mai Huynh, Center for Veterinary
Medicine (HFV-142), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote the
international harmonization of regulatory requirements. FDA has
participated in efforts to enhance harmonization and has expressed its
commitment to seek scientifically based harmonized technical procedures
for the development of pharmaceutical products. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for drug development among regulatory agencies in
different countries.
    FDA has actively participated in the International Conference on
Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use for several years to develop harmonized
technical requirements for the approval of human pharmaceutical and
biological products among the European Union, Japan, and the United
States. The VICH is a parallel initiative for veterinary medicinal
products. The VICH is concerned with developing harmonized technical
requirements for the approval of veterinary medicinal products in the
European Union, Japan, and the United States, and includes input from
both regulatory and industry representatives.
    The VICH Steering Committee is composed of member representatives
from the European Commission; European Medicines Evaluation Agency;
European Federation of Animal Health; Committee on Veterinary Medicinal
Products; FDA; the U.S. Department of Agriculture; the Animal Health
Institute; the Japanese Veterinary Pharmaceutical Association; the
Japanese Association of Veterinary Biologics; and the Japanese Ministry
of Agriculture, Forestry, and Fisheries.
    Six observers are eligible to participate in the VICH Steering
Committee: One representative from the government of Australia/New
Zealand, one representative from the industry in Australia/New Zealand,
one representative from the government of Canada, one representative
from the industry of Canada, one representative from the government of
South Africa, and one representative from the industry of South Africa.
The VICH Secretariat, which coordinates the preparation of
documentation, is provided by the International Federation for Animal
Health (IFAH). An IFAH representative also participates in the VICH
Steering Committee meetings.

II. Guidance on Bracketing and Matrixing Designs for Stability Testing
of New Veterinary Drug Substances and Medicinal Products

    In the Federal Register of July 21, 2009 (74 FR 35875), FDA
published a notice of availability for a draft guidance entitled
``Bracketing and Matrixing Designs for Stability Testing of New
Veterinary Drug Substances and Medicinal Products'' (VICH GL45) giving
interested persons until August 20, 2009, to comment on the draft
guidance. FDA did not receive comments on the draft guidance. Comments
received by other VICH member regulatory agencies were considered as
the guidance was finalized. The guidance announced in this notice
finalizes the draft guidance dated July 20, 2009. The final guidance is
a product of the Expert Quality Working Group of the VICH.
    This VICH guidance document provides guidance on bracketing and
matrixing study designs. Specific principles are defined in this
guidance for situations in which bracketing or matrixing can be
applied. This VICH guidance document is intended to address
recommendations on the application of bracketing and matrixing to
stability studies conducted in accordance with principles outlined in
the VICH guidance GFI #73 entitled ``Stability Testing of New
Veterinary Drug Substances and Medicinal Products (Revision) VICH
GL3(R)'' that published in the Federal Register of November 23, 2007
(72 FR 65751).

III. Significance of Guidance

    This guidance, developed under the VICH process, has been revised
to conform with FDA's good guidance practices regulation (21 CFR
10.115). For example, the document has been designated ``guidance''
rather ``guideline.'' In addition, guidance documents must not include
mandatory language such as ``shall,'' ``must,'' ``require,'' or
``requirements,'' unless FDA is using these words to describe a
statutory or regulatory requirement. The guidance represents the
current thinking of FDA on Bracketing and Matrixing Designs for
Stability Testing of New Veterinary Drug Substances and Medicinal
Products. 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 applicable statutes and regulations.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
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 part 514 have been approved under
OMB control number 0910-0032.

V. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

VI. Electronic Access

    Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/cvm or http://www.regulations.gov.

    Dated: July 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18796 Filed 7-30-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 114 (Tuesday, June 14, 2022)]
[Rules and Regulations]
[Pages 35896-35897]
[FR Doc No: 2022-12694]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2022-0311; Airspace Docket No. 22-ASW-7]
RIN 2120-AA66

Amendment of Class E Airspace; Graham, TX

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends the Class E airspace at Graham, TX. The FAA
is finalizing this action due to an airspace review conducted as part
of the decommissioning of the Graham non-directional beacon (NDB). The
geographic coordinates of the airport are also being updated to
coincide with the FAA's aeronautical database.

DATES: Effective 0901 UTC, September 8, 2022. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order JO 7400.11
and publication of conforming amendments.

ADDRESSES: FAA Order JO 7400.11F, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends the Class E airspace extending upward from 700 feet above
the surface at Graham Municipal Airport, Graham, TX, to support
instrument flight rule operations at this airport.

History

    The FAA published a notice of proposed rulemaking in the Federal
Register (87 FR 21066; April 11, 2022) for Docket No. FAA-2022-0311 to
amend the Class E airspace at Graham, TX. Interested parties were
invited to participate in this rulemaking effort by submitting written
comments on the

proposal to the FAA. No comments were received.
    Class E airspace designations are published in paragraph 6005 of
FAA Order JO 7400.11F, dated August 10, 2021, and effective September
15, 2021, which is incorporated by reference in 14 CFR 71.1. The Class
E airspace designations listed in this document will be published
subsequently in FAA Order JO 7400.11F.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order JO 7400.11F, Airspace Designations
and Reporting Points, dated August 10, 2021, and effective September
15, 2021. FAA Order JO 7400.11F is publicly available as listed in the
ADDRESSES section of this document. FAA Order JO 7400.11F lists Class
A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This amendment to 14 CFR 71 amends the Class E airspace extending
upward from 700 feet above the surface to within a 6.5-mile (increased
from a 6.4-mile) radius of Graham Municipal Airport, Graham, TX;
removes the Graham RBN and the associated extension from the airspace
legal description; and updates the geographic coordinates of the
airport to coincide with the FAA's aeronautical database.
    This action is the result of an airspace review conducted as part
of the decommissioning of the Graham NDB which provided navigation
information for the instrument procedures at this airport.
    FAA Order JO 7400.11, Airspace Designations and Reporting Points,
is published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, Environmental Impacts: Policies and Procedures,
paragraph 5-6.5.a. This airspace action is not expected to cause any
potentially significant environmental impacts, and no extraordinary
circumstances exist that warrant preparation of an environmental
assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    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.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11F, Airspace Designations and Reporting Points, dated August 10,
2021, and effective September 15, 2021, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ASW TX E5 Graham, TX [Amended]

Graham Municipal Airport, TX
    (Lat. 33[deg]06'39'' N, long. 98[deg]33'17'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.5-mile radius of Graham Municipal Airport.

    Issued in Fort Worth, Texas, on June 8, 2022.
Martin A. Skinner,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2022-12694 Filed 6-13-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 150 (Monday, August 7, 2017)]
[Notices]
[Pages 36792-36794]
[FR Doc No: 2017-16581]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]

Product-Specific Guidances; Final Guidances for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of final product-specific guidances. The guidances
provide product-specific recommendations on, among other things, the
design of bioequivalence (BE) studies to support abbreviated new drug
applications (ANDAs). In the Federal Register of June 11, 2010, FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products'' that explained
the process that would be used to make product-specific BE
recommendations available to the public on FDA's Web site. The product-
specific guidances identified in this notice were developed using the
process described in that guidance.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

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-2007-D-0369 for ``Product-Specific

Guidances; Final Guidances for Industry.'' 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 a final guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to a final guidance document.

FOR FURTHER INFORMATION CONTACT: Xiaoqiu Tang, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301-
796-5850.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products'' that explained
the process that would be used to make product-specific guidances
available to the public on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
    As described in that guidance, FDA adopted this process as a means
to develop and disseminate product-specific guidances and provide a
meaningful opportunity for the public to consider and comment on those
guidances. Under that process, draft guidances are posted on FDA's Web
site and announced periodically in the Federal Register. The public is
encouraged to submit comments on those recommendations within 60 days
of their announcement in the Federal Register. FDA considers any
comments received and either publishes final guidances or publishes
revised draft guidances for comment. Final product-specific guidances
were last announced in the Federal Register on September 21, 2015 (80
FR 57000). This notice announces final product-specific guidances that
are posted on FDA's Web site.

II. Drug Products For Which Final Product-Specific Guidances Are
Available

    FDA is announcing the availability of final product-specific
guidances for industry for drug products containing the following
active ingredients:

       Table 1--Final Product-Specific Guidances for Drug Products
------------------------------------------------------------------------

-------------------------------------------------------------------------
Acarbose.
Acetaminophen; Aspirin, Caffeine.
Acetaminophen; Butalbital; Caffeine; Codeine phosphate.
Acitretin.
Amoxicillin (multiple reference listed drugs).
Amoxicillin; Clavulanate potassium.
Aspirin; Butalbital; Caffeine (multiple reference listed drugs).
Aspirin; Butalbital; Caffeine; Codeine Phosphate.
Atenolol.
Atenolol and Chlorthalidone.
Cetirizine HCl.
Chlorthalidone.
Citalopram HBr.
Citalopram hydrobromide.
Clarithromycin.
Clindamycin HCl.
Clomiphene Citrate.
Clonazepam.
Clozapine.
Cyclobenzaprine HCL.
Cycloserine.
Dapsone.
Desipramine HCl.
Desmopressin Acetate.
Diflunisal.
Diphenhydramine HCl.
Dipyridamole.
Disulfiram.
Donepezil HCl.
Doxazosin mesylate.
Doxepin HCl.
Doxercalciferol.
Eprosartan Mesylate.
Ethambutol HCl.
Hydrochlorothiazide; Losartan Potassium.
Hydrochlorothiazide; Triamterene.
Hydrochlorothiazide; Valsartan.
Hydrocodone bitartrate; Ibuprofen.
Hydrocortisone.
Hydromorphone HCl.
Selegiline hydrochloride.
Sotalol HCl.
Tenofovir Disoproxil Fumarate.
Tiagabine HCl.
Valproic acid.
Verapamil HCl.
------------------------------------------------------------------------

    For a complete history of previously published Federal Register
notices related to product-specific guidances, go to https://www.regulations.gov and enter Docket No. FDA-2007-D-0369.
    These final guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). These guidances
represent the current thinking of FDA on, among other things, the
product-specific design of BE studies to support ANDAs. They do not
establish any rights for any person and are not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

III. Electronic Access

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

    Dated: August 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-16581 Filed 8-4-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 148 (Friday, August 1, 2014)]
[Rules and Regulations]
[Pages 44666-44669]
[FR Doc No: 2014-17467]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0196; Directorate Identifier 2014-NM-015-AD;
Amendment 39-17913; AD 2014-15-11]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc. Airplanes

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

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Bombardier, Inc. Model CL-600-2C10 (Regional Jet Series 700, 701, &
702) airplanes, Model CL-600-2D15 (Regional Jet Series 705) airplanes,
Model CL-600-2D24 (Regional Jet Series 900) airplanes, and Model CL-
600-2E25 (Regional Jet Series 1000) airplanes. This AD was prompted by
two in-service reports of fracture of the rudder pedal tubes installed
on the pilot-side rudder bar assembly. This AD requires repetitive
inspections for cracking and damage of the pilot-side rudder pedal
tubes, and corrective action if necessary. This AD also provides
optional terminating action for the repetitive inspections. We are
issuing this AD to detect and correct cracked and damaged pilot-side
rudder pedal tubes, which could result in loss of function of the
pilot's rudder pedal during flight, takeoff, or landing, and could
result in reduced controllability of the airplane.

DATES: This AD becomes effective September 5, 2014.
    The Director of the Federal Register approved the incorporation by
reference

of a certain publication listed in this AD as of September 5, 2014.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2014-0196 or in person at the
Docket Management Facility, U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC.
    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<PHONE_NUMBER>; email
<EMAIL_ADDRESS>Internet http://www.bombardier.com. You
may view this referenced service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.

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, NY
11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain Bombardier, Inc.
Model CL-600-2C10 (Regional Jet Series 700, 701, & 702) airplanes,
Model CL-600-2D15 (Regional Jet Series 705) airplanes, Model CL-600-
2D24 (Regional Jet Series 900) airplanes, and Model CL-600-2E25
(Regional Jet Series 1000) airplanes. The NPRM published in the Federal
Register on April 14, 2014 (79 FR 20829).
    Transport Canada Civil Aviation (TCCA), which is the airworthiness
authority for Canada, has issued Canadian Airworthiness Directive CF-
2014-02, dated January 8, 2014 (referred to after this as the Mandatory
Continuing Airworthiness Information, or ``the MCAI''). The MCAI
states:

    There have been two in-service reports of fracture of the rudder
pedal tubes installed on the pilot-side rudder bar assembly on CL-
600-2B19 model aeroplanes.
    Laboratory examination of the fractured rudder pedal tubes found
that in both cases, the fatigue cracks initiated at the aft taper
pin holes where the connecting rod fitting is attached. Fatigue
testing of the rudder pedal tubes confirmed that the fatigue
cracking is due to loads induced during parking brake application.
Therefore, only the rudder pedal tubes on the pilot's side are
vulnerable to fatigue cracking as the parking brake is primarily
applied by the pilot.
    Loss of pilot rudder pedal input during flight would result in
reduced yaw controllability of the aeroplane. Loss of pilot rudder
pedal input during takeoff or landing may lead to a runway
excursion.
    Although there have been no reported failures to date on any CL-
600-2C10, -2D15, -2D24, and -2D25 model aeroplanes, the same torque
tubes part number (P/N) 600-90204-3 are installed, which may be
prone to premature fatigue cracking.
    This [Canadian] AD mandates initial and repetitive [detailed and
eddy current] inspections [for cracking and damage] of the pilot-
side rudder pedal tubes, P/N 600-90204-3, until the terminating
action [replacement of both pilot-side rudder bar assemblies] is
accomplished [and corrective actions if necessary].

Corrective actions include replacement of the rudder bar assembly and
repair. You may examine the MCAI in the AD docket on the Internet at
http://www.regulations.gov/#!documentDetail;D=FAA-2014-0196-0002.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (79 FR 20829, April 14,
2014) or on the determination of the cost to the public.

``Contacting the Manufacturer'' Paragraph in This AD

    Since late 2006, we have included a standard paragraph titled
``Airworthy Product'' in all MCAI ADs in which the FAA develops an AD
based on a foreign authority's AD.
    The MCAI or referenced service information in an FAA AD often
directs the owner/operator to contact the manufacturer for corrective
actions, such as a repair. Briefly, the Airworthy Product paragraph
allowed owners/operators to use corrective actions provided by the
manufacturer if those actions were FAA-approved. In addition, the
paragraph stated that any actions approved by the State of Design
Authority (or its delegated agent) are considered to be FAA-approved.
    In the NPRM (79 FR 20829, April 14, 2014), we proposed to prevent
the use of repairs that were not specifically developed to correct the
unsafe condition, by requiring that the repair approval provided by the
State of Design Authority or its delegated agent specifically refer to
this FAA AD. This change was intended to clarify the method of
compliance and to provide operators with better visibility of repairs
that are specifically developed and approved to correct the unsafe
condition. In addition, we proposed to change the phrase ``its
delegated agent'' to include a design approval holder (DAH) with State
of Design Authority design organization approval (DOA), as applicable,
to refer to a DAH authorized to approve required repairs for the
proposed AD.
    No comments were provided to the NPRM (79 FR 20829, April 14, 2014)
about these proposed changes. However, a comment was provided for a
similar NPRM, Directorate Identifier 2012-NM-101-AD (78 FR 78285,
December 26, 2013). The commenter stated the following: ``The proposed
wording, being specific to repairs, eliminates the interpretation that
Airbus messages are acceptable for approving minor deviations
(corrective actions) needed during accomplishment of an AD mandated
Airbus service bulletin.''
    This comment has made the FAA aware that some operators have
misunderstood or misinterpreted the Airworthy Product paragraph to
allow the owner/operator to use messages provided by the manufacturer
as approval of deviations during the accomplishment of an AD-mandated
action. The Airworthy Product paragraph does not approve messages or
other information provided by the manufacturer for deviations to the
requirements of the AD-mandated actions. The Airworthy Product
paragraph only addresses the requirement to contact the manufacturer
for corrective actions for the identified unsafe condition and does not
cover deviations from other AD requirements. However, deviations to AD-
required actions are addressed in 14 CFR 39.17, and anyone may request
the approval for an alternative method of compliance to the AD-required
actions using the procedures found in 14 CFR 39.19.
    To address this misunderstanding and misinterpretation of the
Airworthy Product paragraph, we have changed that paragraph and
retitled it ``Contacting the Manufacturer.'' This paragraph now
clarifies that for any requirement in this AD to obtain corrective
actions from a manufacturer, the action must be accomplished using a
method approved by the FAA, TCCA, or Bombardier, Inc.'s TCCA Design
Approval Organization (DAO).
    The Contacting the Manufacturer paragraph also clarifies that, if
approved by the DAO, the approval must include the DAO-authorized
signature. The DAO signature indicates that the data and information
contained in the document are TCCA-approved, which is also FAA-
approved. Messages and other information provided by the manufacturer
that do not contain the DAO-authorized signature approval are

not TCCA-approved, unless TCCA directly approves the manufacturer's
message or other information.
    This clarification does not remove flexibility previously afforded
by the Airworthy Product paragraph. Consistent with long-standing FAA
policy, such flexibility was never intended for required actions. This
is also consistent with the recommendation of the Airworthiness
Directive Implementation Aviation Rulemaking Committee to increase
flexibility in complying with ADs by identifying those actions in
manufacturers' service instructions that are ``Required for
Compliance'' with ADs. We continue to work with manufacturers to
implement this recommendation. But once we determine that an action is
required, any deviation from the requirement must be approved as an
alternative method of compliance.
    Other commenters to the NPRM discussed previously, Directorate
Identifier 2012-NM-101-AD (78 FR 78285, December 26, 2013), pointed out
that in many cases the foreign manufacturer's service bulletin and the
foreign authority's MCAI might have been issued some time before the
FAA AD. Therefore, the DOA might have provided U.S. operators with an
approved repair, developed with full awareness of the unsafe condition,
before the FAA AD is issued. Under these circumstances, to comply with
the FAA AD, the operator would be required to go back to the
manufacturer's DOA and obtain a new approval document, adding time and
expense to the compliance process with no safety benefit.
    Based on these comments, we removed the requirement that the DAH-
provided repair specifically refer to this AD. Before adopting such a
requirement, the FAA will coordinate with affected DAHs and verify they
are prepared to implement means to ensure that their repair approvals
consider the unsafe condition addressed in this AD. Any such
requirements will be adopted through the normal AD rulemaking process,
including notice-and-comment procedures, when appropriate.
    We also have decided not to include a generic reference to either
the ``delegated agent'' or ``DAH with State of Design Authority design
organization approval,'' but instead we have provided the specific
delegation approval granted by the State of Design Authority for the
DAH throughout this AD.

Conclusion

    We reviewed the relevant data and determined that air safety and
the public interest require adopting this AD with the changes described
previously and minor editorial changes. We have determined that these
minor changes:
     Are consistent with the intent that was proposed in the
NPRM (79 FR 20829, April 14, 2014) for correcting the unsafe condition;
and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (79 FR 20829, April 14, 2014).
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of this AD.

Costs of Compliance

    We estimate that this AD affects 400 airplanes of U.S. registry.
    We also estimate that it takes about 3 work-hours per product to
comply with the basic inspection requirements of this AD. The average
labor rate is $85 per work-hour. Based on these figures, we estimate
the cost of this AD on U.S. operators to be $102,000, or $255 per
airplane, per inspection cycle.
    In addition, we estimate that any necessary replacement of the
rudder pedal tubes takes about 6 work-hours and require parts costing
$2,850, for a cost of $3,360 per product. We have no way of determining
the number of aircraft that might need this action.
    We have received no definitive data that would enable us to provide
cost estimates for the on-condition repairs specified in this AD.

Authority for This Rulemaking

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

Regulatory Findings

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

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2014-0196; or in person at the
Docket Management Facility between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays. The AD docket contains this AD, the
regulatory evaluation, any comments received, and other information.
The street address for the Docket Operations office (telephone 800-647-
5527) is in the ADDRESSES section.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2014-15-11 Bombardier, Inc.: Amendment 39-17913. Docket No. FAA-
2014-0196; Directorate Identifier 2014-NM-015-AD.

(a) Effective Date

    This AD becomes effective September 5, 2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the airplanes identified in paragraphs
(c)(1), (c)(2), and (c)(3) of this AD, certificated in any category.
    (1) Bombardier, Inc. Model CL-600-2C10 (Regional Jet Series 700,
701, & 702) airplanes, serial numbers 10002 through 10342 inclusive.
    (2) Bombardier, Inc. Model CL-600-2D15 (Regional Jet Series
705), and Model CL-600-2D24 (Regional Jet Series 900) airplanes,
serial numbers 15001 through 15337 inclusive.
    (3) Bombardier, Inc. Model CL-600-2E25 (Regional Jet Series
1000) airplanes, serial numbers 19001 through 19040 inclusive.

(d) Subject

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

(e) Reason

    This AD was prompted by two in-service reports of fracture of
the rudder pedal tubes installed on the pilot-side rudder bar
assembly. We are issuing this AD to detect and correct cracked and
damaged pilot-side rudder pedal tubes, which could result in loss of
function of the pilot's rudder pedal during flight, takeoff, or
landing, and could result in reduced controllability of the
airplane.

(f) Compliance

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

(g) Repetitive Inspections

    Before the accumulation of 26,000 total flight cycles or within
3 months after the effective date of this AD, whichever occurs
later: Perform a detailed or eddy current inspection for cracking
around the aft tapered holes of both pilot-side rudder pedal tubes,
and for damage of the rudder pedal tubes in locations other than
around the aft tapered holes, in accordance with Part A of the
Accomplishment Instructions of Bombardier Service Bulletin 670BA-27-
065, including Appendix A, dated November 15, 2013. Repeat the
inspection thereafter at the applicable intervals specified in
paragraph (g)(1) or (g)(2) of this AD, until the terminating action
specified in paragraph (i) of this AD is done.
    (1) If the most recent inspection was a detailed inspection:
Within 750 flight cycles after doing the detailed inspection.
    (2) If the most recent inspection was an eddy current
inspection: Within 1,250 flight cycles after doing the eddy current
inspection.

(h) Corrective Actions

    (1) If any crack is found around the aft tapered holes during
any inspection required by paragraph (g) of this AD, before further
flight, replace the rudder bar assembly, in accordance with Part B
of the Accomplishment Instructions of Bombardier Service Bulletin
670BA-27-065, including Appendix A, dated November 15, 2013.
    (2) If any damage is found during any inspection required by
paragraph (g) of this AD in a location other than around the aft
tapered holes: Before further flight, repair using a method approved
by the Manager, New York ACO, ANE-170, Engine and Propeller
Directorate, FAA; or Transport Canada Civil Aviation (TCCA); or
Bombardier, Inc.'s TCCA Design Approval Organization (DAO). If
approved by the DAO, the approval must include the DAO-authorized
signature.

(i) Optional Terminating Action

    Replacement of both pilot-side rudder bar assemblies, in
accordance with Part B of the Accomplishment Instructions of
Bombardier Service Bulletin 670BA-27-065, including Appendix A,
dated November 15, 2013, constitutes terminating action for the
repetitive inspections required by paragraph (g) of this AD.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office (ACO), ANE-170, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. Send information to ATTN: Program
Manager, Continuing Operational Safety, FAA, New York ACO, 1600
Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-
7300; fax<PHONE_NUMBER>. Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office/
certificate holding district office. The AMOC approval letter must
specifically reference this AD.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, New York ACO,
ANE-170, Engine and Propeller Directorate, FAA; or TCCA; or
Bombardier, Inc.'s TCCA Design Approval Organization (DAO). If
approved by the DAO, the approval must include the DAO-authorized
signature.

(k) Related Information

    Refer to Mandatory Continuing Airworthiness Information (MCAI)
Canadian Airworthiness Directive CF-2014-02, dated January 8, 2014,
for related information. This MCAI may be found in the AD docket on
the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-
2014-0196-0002.

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Bombardier Service Bulletin 670BA-27-065, including Appendix
A, dated November 15, 2013.
    (ii) Reserved.
    (3) 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.
    (4) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on July 17, 2014.
John P. Piccola,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-17467 Filed 7-31-14; 8:45 am]
BILLING CODE 4910-13-P