[Federal Register: June 9, 2009 (Volume 74, Number 109)]
[Notices]
[Page 27325-27326]
[DOCID:fr09jn09-67]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0148] (formerly Docket No. 2007D-0493)

International Conference on Harmonisation; Guidance on Q8(R1)
Pharmaceutical Development; Addition of Annex; 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 entitled ``Q8(R1) Pharmaceutical
Development.'' The guidance was prepared under the auspices of the
International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH). The ICH Q8(R1)
guidance includes the previously published parent guidance entitled
``Q8 Pharmaceutical Development'' (Q8 parent guidance) (71 FR 29344;
May 22, 2006) and a newly added annex. The annex provides

further clarification of key concepts outlined in the Q8 parent
guidance and describes the principles of quality by design (QbD). The
annex is intended to show how concepts and tools (e.g., design space)
outlined in the Q8 parent guidance could be put into practice by the
applicant for all dosage forms.

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

ADDRESSES: Submit written requests for single copies of the guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 2201, Silver Spring, MD 20993-0002, or the Office of
Communication, Outreach and Development (HFM-40), Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852-1448. The guidance may
also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-
1800. Send two self-addressed adhesive labels to assist the office in
processing your requests. Submit written comments on the guidance to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to http://www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for electronic access to the guidance
document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Moheb Nasr, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
21, rm. 2630, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or
    Christopher Joneckis, Center for Biologics Evaluation and Research
(HFM-25), Food and Drug Administration, 1401 Rockville Pike, suite 200,
Rockville, MD 20852-1448,<PHONE_NUMBER>.
    Regarding the ICH: Michelle Limoli, Office of International
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for drug development among regulatory agencies.
    ICH was organized to provide an opportunity for tripartite
harmonization initiatives to be developed with input from both
regulatory and industry representatives. FDA also seeks input from
consumer representatives and others. ICH is concerned with
harmonization of technical requirements for the registration of
pharmaceutical products among three regions: The European Union, Japan,
and the United States. The six ICH sponsors are the European
Commission; the European Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of Health, Labour, and Welfare; the
Japanese Pharmaceutical Manufacturers Association; the Centers for Drug
Evaluation and Research and Biologics Evaluation and Research, FDA; and
the Pharmaceutical Research and Manufacturers of America. The ICH
Secretariat, which coordinates the preparation of documentation, is
provided by the International Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
    The ICH Steering Committee includes representatives from each of
the ICH sponsors and the IFPMA, as well as observers from the World
Health Organization, Health Canada, and the European Free Trade Area.
    In the Federal Register of January 10, 2008 (73 FR 1890), FDA
published a notice announcing the availability of a draft guidance
entitled ``Q8(R1) Pharmaceutical Development Revision 1.'' The notice
gave interested persons an opportunity to submit comments by April 9,
2008.
    After consideration of the comments received and revisions to the
guidance, a final draft of the guidance was submitted to the ICH
Steering Committee and endorsed by the three participating regulatory
agencies in November 2008. Revisions were made in response to comments
received by the three ICH regions to better express the original intent
of the draft.
    The annex added to the Q8 parent guidance provides further
clarification of key concepts outlined in the Q8 parent guidance and
describes the principles of QbD. The annex is not intended to establish
new standards or increase regulatory expectations. It is intended to
show how concepts and tools (e.g., design space) outlined in the Q8
parent guidance could be put into practice by the applicant for all
dosage forms. Following the addition of the annex to the Q8 parent
guidance, ICH recoded the parent guidance Q8(R1).
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on this topic. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written comments on the guidance. 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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.regulations.gov, http://www.fda.gov/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
http://www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatoryInformation/default.htm.

    Dated: May 27, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-13374 Filed 6-8-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 83, Number 177 (Wednesday, September 12, 2018)]
[Notices]
[Pages 46170-46172]
[FR Doc No: 2018-19816]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3010]

Evidence-Based Treatment Decision in Transplantation: Patient
Individualized Treatment; Choosing the Right Regimen for the Right
Patient; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public workshop entitled ``Evidence-Based
Treatment Decision in Transplantation: Patient Individualized
Treatment; Choosing the Right Regimen for the Right Patient.'' This
public workshop is intended to discuss potential candidate biomarkers
to determine organ transplant patients' immunologic risk for organ
rejection or tolerance. The public workshop will include discussion of
the biomarker qualification process and how it could be used to develop
biomarkers for use in clinical trials in transplantation, to develop
new drugs to address unmet needs, and in clinical practice to guide
patient treatment selection. Speakers will be patients who will provide
perspective on the challenges of living with a transplant, managing
immunosuppression and perspectives on tolerability, adherence, and risk
that may inform patient-reported outcome (PRO) and patient-focused drug
development.

DATES: The public workshop will be held on September 27, 2018, from
8:30 a.m. to 6 p.m. and September 28, 2018, from 8 a.m. to 12:30 p.m.
Submit either electronic or written comments on this public workshop by
November 19, 2018. See the SUPPLEMENTARY INFORMATION section for
registration date and information.

ADDRESSES: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great
Room (Rm. 1503, sections B and C), Silver Spring, MD 20993. Entrance
for the public workshop participants (non-FDA employees) is through
Building 1 where routine security check procedures will be performed.
For parking and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before November 19, 2018. The

https://www.regulations.gov electronic filing system will accept
comments until midnight Eastern Time at the end of November 19, 2018.
Comments received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are postmarked or the
delivery service acceptance receipt is on or before that date.

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-2018-N-3010 for ``Evidence-Based Treatment Decision in
Transplantation: Patient Individualized Treatment; Choosing the Right
Regimen for the Right Patient.'' Received comments, those filed in a
timely manner (see ADDRESSES), 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.

FOR FURTHER INFORMATION CONTACT: Derek Alberding or Ramou Pratt, Food
and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD
20993,<PHONE_NUMBER>, [email protected], or<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing a public workshop entitled ``Evidence-Based
Treatment Decision in Transplantation: Patient Individualized
Treatment; Choosing the Right Regimen for the Right Patient.'' This
public workshop is intended for academic experts, industry, healthcare
providers, patients, other U.S. Government Agencies, and other
stakeholders.

II. Topics for Discussion at the Public Workshop

    Presentations and discussions will cover identifying potential
candidate biomarkers that could:
     Be considered for the biomarker qualification process
     be used in identifying patients at high immunologic risk
or low immunologic risk
     be used in clinical trials to develop drugs to address
unmet individual needs in transplantation
     be used to make appropriate immunosuppressive regimen
treatment decisions
    In addition, patient speakers will provide perspectives on:
     Challenges of living with a transplant,
     managing immunosuppression, and
     tolerability, adherence, and risk of therapy.
    The goal of these presentations is to inform PRO and patient-
focused drug development.

III. Participating in the Public Workshop

    Registration: Registration is free and based on space availability,
with priority given to early registrants. Persons interested in
attending this public workshop must register by September 14, 2018,
midnight Eastern Time. To register, please provide complete contact
information for each attendee, including name, title, affiliation,
address, email, and telephone to
[email protected].
    Early registration is recommended because seating is limited;
therefore, FDA may limit the number of participants from each
organization. Registrants will receive confirmation when they have been
accepted. If time and space permit, onsite registration on the day of
the public workshop will be provided beginning at 7:30 a.m. We will let
registrants know if registration closes before the day of the public
workshop.
    If you need special accommodations due to a disability, please
contact Derek Alberding or Ramou Pratt (see FOR FURTHER INFORMATION
CONTACT) no later than September 13, 2018.
    Requests for Oral Presentations: During online registration you may
indicate if you wish to present during a public comment session and
which topic(s) you wish to address. We will do our best to accommodate
requests to make public comments. Individuals and

organizations with common interests are urged to consolidate or
coordinate their presentations, and request time for a joint
presentation, or submit requests for designated representatives to
participate in the focused sessions. Following the close of
registration, we will determine the amount of time allotted to each
presenter and the approximate time each oral presentation is to begin,
and will select and notify participants by September 14, 2018. All
requests to make oral presentations must be received by September 10,
2018. If selected for presentation, any presentation materials must be
emailed to [email protected] (see FOR FURTHER
INFORMATION CONTACT) no later than September 19, 2018. No commercial or
promotional material will be permitted to be presented or distributed
at the public workshop.
    Streaming Webcast of the Public Workshop: This public workshop will
also be webcast at https://collaboration.fda.gov/ebtd092018/.
    If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program,
visit https://www.adobe.com/go/connectpro_overview. FDA has verified
the website addresses in this document, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.
    Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at https://www.fda.gov/Drugs/NewsEvents/ucm605761.htm.

    Dated: September 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19816 Filed 9-11-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: September 29, 2006 (Volume 71, Number 189)]
[Notices]
[Page 57509-57510]
[DOCID:fr29se06-80]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0291; FRL-8097-2]

Pesticides; Draft Guidance for Pesticide Registrants on Small-
Scale Field Testing and Low-level Intermittent Presence in Food of
Plant-Incorporated Protectants (PIPs)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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SUMMARY:  The Agency is announcing the availability of and seeking
public comment on a draft Pesticide Registration Notice (PRN) entitled
``Guidance on Small-Scale Field Testing and Low-level Intermittent
Presence in Food of Plant-Incorporated Protectants (PIPs).'' PRNs are
issued by the Office of Pesticide Programs (OPP) to inform pesticide
registrants and other interested persons about important policies,
procedures, and registration related decisions, and serve to provide
guidance to pesticide registrants and OPP personnel. This particular
draft PRN provides guidance to the registrant concerning clarification
on the process by which EPA reviews and ensures the safety of low-level
intermittently-present residues of plant-incorporated protectants
(PIPs) in food or feed, and the conditions under which a tolerance or
exemption from the requirement of a tolerance would be required for
field tests for biotechnology-derived food and feed crop plants
containing plant-incorporated protectants.

DATES: Comments must be received on or before November 28, 2006.

ADDRESSES:  Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0291, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0291. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The Federal regulations.gov Web site is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
regulations.gov, your e-mail address will be automatically captured and
included as part of the comment that is placed in the docket and made
available on the Internet. If you submit an electronic comment, EPA
recommends that you include your name and other contact information in
the body of your comment and with any disk or CD-ROM you submit. If EPA
cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index.
Although listed in the index, some information is not publicly
available, e.g., 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 in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the OPP

Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. The hours of operation
of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The Docket telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Patricia Moe, 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>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me

    This action is directed to the public in general. Although this
action may be of particular interest to those persons who are involved
in plant breeding using plant-incorporated protectants including but
not limited to academic researchers, seed companies, and PIP
registrants. Since other entities may also be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
information in this notice, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

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 e-mail. 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.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established a docket for this action under
docket identification (ID) number EPA-HQ-OPP-2006-0291. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard

copy, at the Office of Pesticide Programs (OPP) Regulatory Public
Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S.
Crystal Drive Arlington, VA. The hours of operation of this Docket
Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding
legal holidays. The Docket telephone number is<PHONE_NUMBER>.
    2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr.

II. What Guidance Does this PRN Provide?

    This draft PRN provides guidance to the registrant concerning the
policies described in the August 2, 2002 Federal Register (67 FR 50578)
Notice on ``Proposed Federal Actions to Update Field Test Requirements
for Biotechnology Derived Plants and to Establish Early Food Safety
Assessments for New Proteins Produced by Such Plants'' issued under the
auspices of the Office of Science and Technology Policy (OSTP). The
OSTP notice was issued to outline what measures federal agencies would
take to prevent low levels of biotechnology derived genes and gene
products from being found in commercial food and feed. The OSTP notice
stated that EPA would rely on existing processes and publish guidance
for individuals and organizations conducting field testing of Plant-
Incorporated Protectants (PIPs). The proposed PRN describes those
existing rules along with the existing procedures related to them.
Additionally, the PRN provides guidance on residue containment in
small-scale field testing and the kinds of information that EPA has
received to support the PIP tolerances issued thus far.
    No actions are required of registrants or other individuals
involved in small scale field testing of PIPs as a result of this PRN.
The PRN provides guidance and helps explain the existing rules and
regulations pertinent to this topic and provides a point of contact for
those wishing to discuss the issue or ask questions related to specific
test parameters. The PRN is also intended to reinforce coordination of
EPA regulatory efforts related to biotechnology products with those of
the Food and Drug Administration (FDA) and of the U.S. Department of
Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS),
as outlined under the Coordinated Framework for the Regulation of the
Products of Biotechnology.

III. Do PRNs Contain Binding Requirements?

    The PRN discussed in this document is intended to provide guidance
to EPA personnel and decision makers and to pesticide registrants.
While the requirements in the statutes and Agency regulations are
binding on EPA and the applicants, this PRN is not binding on either
EPA or pesticide registrants, and EPA may depart from the guidance
where circumstances warrant and without prior notice. Likewise,
pesticide registrants may assert that the guidance is not appropriate
generally or not applicable to a specific pesticide or situation.

List of Subjects

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests.

    Dated: September 22, 2006.
James Jones,
Director, Office of Pesticide Programs.
[FR Doc. E6-16072 Filed 9-28-06; 8:45 am]

BILLING CODE 6560-50-S


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer and on behalf of my family to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to my family and me, as consumers of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I believe e-cigarettes are a great alternative to other tobacco products. They have helped me personally quit dipping and other memebers of my family to quit smoking. Quite simply, I firmly believe that they saved my life and other friends and family. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.

Sincerely, Troy Tuttle


[Federal Register Volume 81, Number 96 (Wednesday, May 18, 2016)]
[Notices]
[Pages 31234-31236]
[FR Doc No: 2016-11749]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2013-0290 and EPA-HQ-OAR-2013-0291; FRL-9946-63-OAR]

NESHAP for Brick and Structural Clay Products Manufacturing; and
NESHAP for Clay Ceramics Manufacturing

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of action denying in part and granting in part petitions
for reconsideration.

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SUMMARY: This action provides notice that the U.S. Environmental
Protection Agency (EPA) Administrator, Gina McCarthy, denied in part
and granted in part petitions for reconsideration of the final National
Emission Standards for Hazardous Air Pollutants (NESHAP) for Brick and
Structural Clay Products (BSCP) Manufacturing and the final NESHAP for
Clay Ceramics Manufacturing published in the Federal Register on
October 26, 2015.

DATES: This action is effective on May 18, 2016.

FOR FURTHER INFORMATION CONTACT: Ms. Sharon Nizich, Minerals and

Manufacturing Group, Sector Policies and Programs Division (D243-04),
Office of Air Quality Planning and Standards, U.S. Environmental
Protection Agency, Research Triangle Park, North Carolina 27711;
telephone number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

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

    This Federal Register notice, the petitions for reconsideration,
and the letters and accompanying enclosures addressing the petitions
for reconsideration are available in the dockets the EPA established
under Docket ID No. EPA-HQ-OAR-2013-0291 for BSCP Manufacturing and
Docket ID No. EPA-HQ-OAR-2013-0290 for Clay Ceramics Manufacturing.
    All documents in the dockets are listed on the http://www.regulations.gov Web site. Although listed in the index, some
information is not publicly available, e.g., confidential business
information or other information whose disclosure is restricted by
statute. Certain other material, such as copyrighted material, is not
placed on the Internet and will be publicly available only in hard copy
form. Publicly available docket materials are available either
electronically through http://www.regulations.gov or in hard copy at
the EPA Docket Center (EPA/DC), EPA WJC West Building, Room 3334, 1301
Constitution Ave. NW., Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744 and the telephone number for the Air Docket is<PHONE_NUMBER>.
This Federal Register document, the petitions for reconsideration, and
the letters with the accompanying enclosure addressing the petitions
can also be found on the EPA's Web site at http://www.epa.gov/ttn/oarpg.

II. Judicial Review

    Section 307(b)(1) of the Clean Air Act (CAA) indicates which
Federal Courts of Appeals have venue for petitions for review of final
EPA actions. This section provides, in part, that the petitions for
review must be filed in the Court of Appeals for the District of
Columbia Circuit if: (i) The agency action consists of ``nationally
applicable regulations promulgated, or final action taken, by the
Administrator,'' or (ii) such actions are locally or regionally
applicable, if ``such action is based on a determination of nationwide
scope or effect and if in taking such action the Administrator finds
and publishes that such action is based on such a determination.''
    The EPA has determined that its denial of the petitions for
reconsideration is nationally applicable for purposes of CAA section
307(b)(1) because the actions directly affect the BSCP Manufacturing
NESHAP and Clay Ceramics Manufacturing NESHAP, which are nationally
applicable regulations. Thus, any petitions for review of the letters
and enclosures denying the petitions for reconsideration described in
this document must be filed in the United States Court of Appeals for
the District of Columbia Circuit by July 18, 2016.
    To the extent that EPA is granting the petitions for
reconsideration with respect to certain issues, such grant is not final
agency action, but only begins an agency process to consider whether
the rule should be revised. If EPA in the future takes final agency
action to revise the rule, notice of such action will be published in
the Federal Register and judicial review will be available at that
time.

III. Description of Action

    The initial NESHAP for BSCP Manufacturing and initial NESHAP for
Clay Ceramics Manufacturing were published in the Federal Register on
May 16, 2003 (68 FR 26690), and codified at 40 CFR part 63, subparts
JJJJJ and KKKKK, respectively, pursuant to section 112 of the CAA.
Those standards were challenged and subsequently vacated by the United
States Court of Appeals for the District of Columbia Circuit in 2007.
See Sierra Club v. EPA, 479 F.3d 875, 876 (D.C. Cir. 2007). Following
the 2007 vacatur of the 2003 rule, the EPA collected additional data
and information to support new standards for the BSCP and clay ceramics
industries. This information is contained in the dockets for both
rules, which are available at http://www.regulations.gov. On December
18, 2014, the EPA proposed new NESHAP for BSCP Manufacturing and for
Clay Ceramics Manufacturing (79 FR 75622). The EPA received additional
data and comments during the public comment period. These data and
comments were considered and analyzed and, where appropriate, revisions
to the two NESHAP were made. The NESHAP for BSCP Manufacturing and
NESHAP for Clay Ceramics Manufacturing were finalized on October 26,
2015 (80 FR 65470).
    On December 23, 2015, Kohler Company submitted a petition for
reconsideration of the final rule for Clay Ceramics Manufacturing (80
FR 65470). In support of its petition, Kohler Company claimed that: (1)
The final rule introduced new stack temperature monitoring requirements
for demonstrating compliance with the dioxin/furan emission limits
without an opportunity for comment by the petitioner; (2) the EPA
failed to adequately respond to the petitioner's public comments
regarding visible emissions monitoring in the response to comments and
final rule; (3) the EPA should reconsider its exclusion of emissions
averaging from the final rule as a compliance option for clay ceramics
manufacturing; (4) the EPA should reconsider its improper use of
scrubber emissions data from the petitioner's South Carolina Kiln 10
for determining the maximum achievable control technology (MACT) floor;
(5) the EPA should reconsider the frequency of onerous and unnecessary
visual inspection requirements for system ductwork and control device
equipment for water curtain spray booths; and (6) the EPA should
clarify the testing threshold for cooling stacks to be tested to limit
it to those stacks with an oxygen content at or below 20.4 percent.
    Also on December 23, 2015, the Brick Industry Association (BIA)
submitted a petition for reconsideration of the final rule for BSCP
Manufacturing (80 FR 65470). In support of its petition, the BIA
claimed that: (1) The EPA failed to give notice that it would change
its method for calculating the existing source MACT floor for emissions
of non-mercury (Hg) hazardous air pollutant (HAP) metals; (2) the EPA
incorrectly used tests conducted below capacity in its revised MACT
floor approach; (3) the EPA failed to give notice that it would include
a variability calculation in its determination of the MACT floor for Hg
or how it would make this variability calculation; (4) it was
impracticable for the petitioner to request a variability factor for
non-Hg metal emission limits for the final rule; and (5) the EPA failed
to give notice that it would include opacity as a compliance method for
the non-Hg HAP metals standard.
    On December 24, 2015, the Tile Council of North America, Inc.
(TCNA) and its members submitted a petition for reconsideration of the
final rule for Clay Ceramics Manufacturing (80 FR 65470). In support of
its petition, the TCNA claimed that: (1) In promulgating the final
rule, the EPA relied on legal positions/rationales for regulating
ceramic tile that were advanced for the first time in the preamble to
the final rule; (2) for the final rule, the EPA introduced for the
first time the technical rationale that Method 23 field

blank spike recoveries self-validate the dioxin/furan emissions data
used to set dioxin/furan standards; and (3) the EPA failed to respond
to public comments regarding the cost of the final rule to those
sources that the EPA postulates might at some time in the future become
subject to the rule.
    Section 307(d)(7)(B) of the CAA sets forth the criteria for
reconsideration. That section states that ``(o)nly an objection to a
rule or procedure which was raised with reasonable specificity during
the period for public comment (including any public hearing) may be
raised during judicial review. If the person raising an objection can
demonstrate to the Administrator that it was impractical to raise such
objection within such time or if the grounds for such objection arose
after the period for public comment (but within the time specified for
judicial review) and if such objection is of central relevance to the
outcome of the rule, the Administrator shall convene a proceeding for
reconsideration of the rule and provide the same procedural rights as
would have been afforded had the information been available at the time
the rule was proposed.''
    The EPA has carefully considered the petitions and supporting
information. In separate letters to the petitioners, the EPA
Administrator, Gina McCarthy, denied in part and granted in part the
Kohler Company petition, denied the BIA and TCNA petitions, and
explained the reasons for the denials. These letters and the
accompanying enclosures are available in the dockets for this action.

IV. Conclusion

    For the reasons discussed in the letters and accompanying enclosure
to the petitioners, the petitions to reconsider the final NESHAP for
BSCP Manufacturing and final NESHAP for Clay Ceramics Manufacturing are
denied in part and granted in part.

    Dated: May 12, 2016.
Gina McCarthy,
Administrator.
[FR Doc. 2016-11749 Filed 5-17-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 23 (Wednesday, February 4, 2015)]
[Rules and Regulations]
[Pages 5900-5902]
[FR Doc No: 2015-01196]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-0099; Directorate Identifier 2014-CE-039-AD;
Amendment 39-18082; AD 2015-02-15]
RIN 2120-AA64

Airworthiness Directives; Quest Aircraft Design, LLC Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for all
Quest Aircraft Design, LLC Model KODIAK 100 airplanes. This AD requires
inspecting the inboard upper and lower elevator skins for cracking,
repairing cracks, and installing doublers. This AD was prompted by a
report that fatigue cracks were found in the lower elevator skins. We
are issuing this AD to correct the unsafe condition on these products.

DATES: This AD is effective February 19, 2015.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of February 19,
2015.
    We must receive comments on this AD by March 23, 2015.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Quest
Aircraft Design, LLC, 1200 Turbine Drive, Sandpoint, Idaho 83864;
telephone:<PHONE_NUMBER>; toll free:<PHONE_NUMBER>; fax: (208) 263-
1511<EMAIL_ADDRESS>www.questaircraft.com. You may
review copies of the referenced service information at the FAA, Small
Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call (816)
329-4148.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
0099; 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 Office (phone:
800-647-5527) is in the ADDRESSES section. Comments will be available
in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Jason Deutschman, Aerospace Engineer,
Seattle Aircraft Certification Office, FAA, 1601 Lind Avenue SW.,
Renton, Washington 98057; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We received a report that an operator found two cracks in the lower
elevator skin, one per elevator, while performing a preflight walk-
around inspection on a Quest Aircraft Design, LLC Model KODIAK 100
airplane.
    The trailing edge skin has a built-in joggle to maintain the
aerodynamic profile of the surface in the presence of a skin lap. The
joggle causes the skin to straighten under tension loads and buckle
under compression loads. We have determined that secondary bending
stresses at the joggle are the direct cause of the cracking.
    This condition, if not corrected, could cause failure of the
elevator skins to sustain limit load, which could result in loss of
elevator control, elevator flutter, or loss of elevator. We are issuing
this AD to correct the unsafe condition on these products.

Relevant Service Information

    We reviewed Quest Aircraft KODIAK Mandatory Service Bulletin SB 14-
09,

Revision 1, dated December 11, 2014, and Quest Aircraft Field Service
Instruction, Elevator Doubler Installation, Elevator Serial Numbers
0001 through 0149, Report No. FSI-106, Revision 02, not dated. The
service information describes procedures for inspecting the inboard
upper and lower skins of the elevator cracking, repairing cracks, and
installing doublers to prevent cracking from occuring. You can find
this information at http://www.regulations.gov by searching for and
locating Docket No. FAA-2015-0099.

FAA's Determination

    We are issuing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

AD Requirements

    This AD requires accomplishing the actions specified in the service
information described previously.

FAA's Justification and Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD. The FAA has found that the risk to the flying public justifies
waiving notice and comment prior to adoption of this rule because
failure of the elevator skins to sustain limit load could result in
loss of elevator control, elevator flutter, or loss of elevator.
Therefore, we find that notice and opportunity for prior public comment
are impracticable and that good cause exists for making this amendment
effective in less than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety and was not preceded by notice and an opportunity for public
comment. However, we invite you to send any written data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include the docket number FAA-2015-0099 and
Directorate Identifier 2014-CE-039-AD at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this AD. We will
consider all comments received by the closing date and may amend this
AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Costs of Compliance

    We estimate that this AD affects 57 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
              Action                      Labor cost             Parts cost           product        operators
----------------------------------------------------------------------------------------------------------------
Inspect the inboard upper and       .5 work-hour x $85     Not applicable.......          $42.50       $2,422.50
 lower skins of the elevator for     per hour = $42.50.
 cracking.
Install doublers..................  4 work-hours x $85     Not applicable.......             340          19,380
                                     per hour = $340.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary repairs that
would be required based on the results of the inspection. We have no
way of determining the number of aircraft that might need this repair:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                 Action                           Labor cost                  Parts cost              product
----------------------------------------------------------------------------------------------------------------
Repair cracks to the inboard upper and    .5 work-hour x $85 per      Not applicable............          $42.50
 lower skins of the elevator.              hour = $42.50.
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some of the costs of this AD may be
covered under warranty, thereby reducing the cost impact on affected
individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

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

    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 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.

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):

2015-02-15 Quest Aircraft Design, LLC: Amendment 39-18082; Docket
No. FAA-2015-0099; Directorate Identifier 2014-CE-039-AD.

(a) Effective Date

    This AD is effective February 19, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Quest Aircraft Design, LLC Model KODIAK 100
airplanes, all serial numbers, that are:
    (1) Equipped with elevators with serial numbers 0001 through
0149; and
    (2) certificated in any category.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 5522; Elevator Skins.

(e) Unsafe Condition

    This AD was prompted by a report that fatigue cracks were found
in the lower elevator skins. We are issuing this AD to correct the
unsafe condition on these products.

(f) Compliance

    Comply with this AD within the compliance times specified in
paragraphs (g) through (j) of this AD, unless already done.

(g) Inspect the Elevator Skins for Cracking

    At or before reaching 1,500 hours time in service (TIS) on the
elevator or within the next 25 hours TIS after February 19, 2015
(the effective date of this AD), whichever occurs later, inspect the
top and bottom of the elevator for cracking in the forward inboard
end of the trailing edge skin, aft of the spar. Do the inspection
following section 4. of Quest Aircraft Field Service Instruction,
Elevator Doubler Installation, Elevator Serial Numbers 0001 through
0149, Report No. FSI-106, Revision 02, not dated, as specified in
Quest Aircraft KODIAK Mandatory Service Bulletin SB 14-09, Revision
1, dated December 11, 2014.

    Note 1 to paragraph (g) of this AD: Quest Aircraft Field Service
Instruction, Elevator Doubler Installation, Elevator Serial Numbers
0001 through 0149, Report No. FSI-106, Revision 02, not dated,
references Advisory Circular 43.13-1B, Section 2. The reference
should state Advisory Circular 43.13-1B, chapter 5, section 2. You
may find Advisory Circular 43.13-1B on the Internet at http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgAdvisoryCircular.nsf/0/99C827DB9BAAC81B86256B4500596C4E?OpenDocument&Highlight=43.13-1b.

(h) Install Doublers

    If no cracking was found during the inspection required in
paragraph (g) of this AD, before further flight after the
inspection, install doublers. Do the installation following section
5.1 of Quest Aircraft Field Service Instruction, Elevator Doubler
Installation, Elevator Serial Numbers 0001 through 0149, Report No.
FSI-106, Revision 02, not dated, as specified in Quest Aircraft
KODIAK Mandatory Service Bulletin SB 14-09, Revision 1, dated
December 11, 2014.

(i) Repair Cracked Elevator Skins and Install Doublers

    If cracking was found during the inspection required in
paragraph (g) of this AD, before further flight after the
inspection, repair the cracks and install doublers, except as
specified in paragraph (j). Do the repair and installation following
section 5.2 of Quest Aircraft Field Service Instruction, Elevator
Doubler Installation, Elevator Serial Numbers 0001 through 0149,
Report No. FSI-106, Revision 02, not dated, as specified in Quest
Aircraft KODIAK Mandatory Service Bulletin SB 14-09, Revision 1,
dated December 11, 2014.

(j) Cracked Elevator Skins That Exceed Service Bulletin Repair Limits

    If the cracking found during the inspection required in
paragraph (g) of this AD exceeds the repair specified in paragraph
(i) of this AD, before further flight, obtain an FAA-approved repair
method from Quest Aircraft by contacting the Manager, Seattle
Aircraft Certification Office (ACO), FAA, as specified in paragraph
(k) of this AD. To use a repair method approved by the Manager of
the Seattle ACO, the approval letter must specifically reference
this AD.

(k) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle ACO, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the manager of the
ACO, send it to the attention of the person identified in paragraph
(m) of this AD.
    (2) 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.

(l) Related Information

    For more information about this AD, contact Jason Deutschman,
Aerospace Engineer, Seattle Aircraft Certification Office, FAA, 1601
Lind Avenue SW., Renton, Washington 98057; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
(m) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Quest Aircraft KODIAK Mandatory Service Bulletin SB 14-09,
Revision 1, dated December 11, 2014.
    (ii) Quest Aircraft Field Service Instruction, Elevator Doubler
Installation, Elevator Serial Numbers 0001 through 0149, Report No.
FSI-106, Revision 02, not dated.
    (3) For Quest Aircraft service information identified in this
AD, contact Quest Aircraft Design, LLC, 1200 Turbine Drive,
Sandpoint, Idaho 83864; telephone:<PHONE_NUMBER>; toll free: (866)
263-1112; fax:<PHONE_NUMBER><EMAIL_ADDRESS>
www.questaircraft.com.
    (4) You may view this service information at FAA, Small Airplane
Directorate, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call
(816) 329-4148.
    (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 Kansas City, Missouri, on January 16, 2015.
Kelly A. Broadway,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-01196 Filed 2-3-15; 8:45 am]
BILLING CODE 4910-13-P