[Federal Register: February 8, 2007 (Volume 72, Number 26)]
[Rules and Regulations]
[Page 5932-5936]
[DOCID:fr08fe07-10]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2006-0915; FRL-8276-3]

Approval and Promulgation of Air Quality Implementation Plans;
West Virginia; Amendments to the Minor New Source Review Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is taking direct final action to approve revisions to the
West Virginia State Implementation Plan (SIP). The revisions set forth
the procedures for stationary source reporting and the criteria for
obtaining a permit to construct and operate a new stationary source
which is not a major stationary source. The rule establishes the
requirements for obtaining an administrative update to an existing
permit, temporary permit or a general permit, and for filling
notifications and maintaining records of changes not otherwise subject
to the permit requirements of this rule. The rule establishes public
participation requirements as well as procedures for the transfer,
suspension and revocation of permits. EPA is approving these revisions
to West Virginia's SIP in accordance with the requirements of the Clean
Air Act.

DATES: This rule is effective on April 9, 2007 without further notice,
unless EPA receives adverse written comment by March 12, 2007. If EPA
receives such comments, it will publish a timely withdrawal of the
direct final rule in the Federal Register and inform the public that
the rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2006-0915 by one of the following methods:
    A. http://www.regulations.gov. Follow the on-line instructions for

submitting comments.
    B. E-mail<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2006-0915, David Campbell, Chief, Permits and
Technical Assessment Branch, Mailcode 3AP11, U.S. Environmental
Protection Agency, Region III, 1650 Arch Street, Philadelphia,
Pennsylvania 19103.
    D. Hand Delivery: At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R03-OAR-
2006-0915. EPA's policy is that all comments received will be included
in the public docket without change, and may be made available online
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 http://www.regulations.gov or e-mail.

The http://www.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 http://www.regulations.gov,

your e-mail address will be automatically captured and included as part
of the comment that is placed in the public 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 electronic docket are listed in the
http://www.regulations.gov index. Although listed in the index, some

information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in http://www.regulations.gov or

in hard copy during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal
are available at the West Virginia Department of Environmental
Protection, Division of Air Quality, 601 57th Street SE, Charleston, WV
25304.

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

I. Background

    On September 10, 2003, the West Virginia Department of the
Environmental Protection (WVDEP) submitted a formal revision to its
State Implementation Plan (SIP). The SIP revision consists of
amendments to West Virginia Legislative Rule 45 CSR 13 issued by the
State of West Virginia on March 6, 2003, and effective June 1, 2003.
The State amended the regulations in order to (1) set forth the
procedures for stationary source reporting and the criteria for
obtaining a permit to construct and operate a new stationary source
which is not a major stationary source and to modify a non-major
stationary source; (2) establishes the requirements for obtaining an
administrative update to an existing permit, temporary permit or a
general permit, and for filling notification and maintaining records of
changes not otherwise subject to the permit requirements of this rule;
and (3) establishes public participation requirements as well as
procedures for the transfer, suspension and revocation of permits. West
Virginia is seeking approval of these amendments to this rule pursuant
to Sections 110(a)(2)(C) and 112(l) of the Clean Air Act, and 40 CFR
51.160 through 51.164.

II. Summary of SIP Revision and Program Review

A. What is being addressed in this document?

    West Virginia Legislative Rule 45 CSR 13 is part of the West
Virginia SIP approved by the USEPA to assure attainment and maintenance
of attainment with the national ambient air quality standards (NAAQS).
The proposed revision were initiated by the West Virginia Department of
the Environment Protection (WVDEP) as part of an effort to streamline
the permitting program by eliminating unnecessary permitting
requirements for insignificant sources, broadening the general permit
mechanism, reducing agency review timeframes for permit action,
modifying applicability thresholds and reducing application fees for
general permits.

B. What are the program changes that EPA is approving?

    The amendments are summarized as follows:
    1. Permitting thresholds for modification and stationary sources
have been revised from six (6) pounds per hour (pph) or more or ten
(10) tons per year (tpy) or more to six (6) pph and ten (10) tpy or
more, or more than 144 pounds per calendar day (ppd) in any regulated
air pollutant (Section 2.17.a) and (Section 2.24.b). WVDEP recognizes
that both thresholds, the 6 pph and 10 tpy and the 144 ppd have the
potential to allow some sources to emit up to 26 tons a year without
obtaining a permit, but WVDEP believes the 144 ppd threshold and the
Department's authority to prevent ``statutory air pollution'' will
serve as useful backstops in those relatively uncommon situations.
    2. The de minimis list in Table 45-13B has been expanded to include
additional commercial and residential maintenance and upkeep
activities. (Table 45-13B, Nos. 39 and 40).
    3. WVDEP review times have been shortened from 180 day to 90 days
for Class II general permit registrations; 180 days to 60 days for
temporary permits; and, 180 days to 45 days for Class I general permits
(Section 5.7). WVDEP will be able to meet the deadlines in this rule.
    4. Revisions to general permit language to expand authority by
removing ``facility-wide'' restriction. Also, a provision for simpler
general permits (Class I) has been added which does not require public
notice for each Class I registration and requires a smaller fee. WVDEP
has added general permit requirements to Section 5.12.
    5. A revision to provide authority to revise general permit
registrations through administrative updates. (Section 4.)
    6. A revision to public notice requirements, from a 45-day notice
at draft permit stage, to a 30-day notice and restored 30-day notice by
applicant at application stage. (Section 8.4.)
    7. A reduction of registration application fees for general permits
from $1,000 to $250 for Class I and $500 for Class II general permits,
with an exception for ``small businesses'' applying for Class I general
permits. Also, an exemption for Class I general permits from the
additional fees for NSPS, NESHAPs, etc. (Section 12.1.)
    8. Revised language which clarifies that commercial display ad and
sign requirements occur contemporaneously with the WVDEP's legal ad (at
draft permit stage), unless the applicant wishes to place the ad/sign
earlier. (Section 8.4.a and 8.5.a.)
    9. Various technical revisions to the rule, i.e., changed Director
to Secretary.

III. Final Action

    EPA is approving these amendments to West Virginia 45 CSR 13--
Permits for Construction, Modification, Relocation and Operation of
Stationary sources of Air Pollutants, Notification Requirements,
Administrative Updates, Temporary Permits, General Permits and
Procedures for Evaluation as a revision to the state's minor new source
review program. The amendments are consistent with 40 CFR 51.160
through 51.164 and sections 110 and 112(l) of the Clean Air Act. EPA is
publishing this rule without prior proposal because the Agency views
this as a noncontroversial amendment and anticipates no adverse
comment. However, in the ``Proposed Rules'' section of today's Federal
Register, EPA is publishing a separate document that will serve as the
proposal to approve the SIP revision if adverse comments are filed.
This rule will be effective on April 9, 2007 without further notice
unless EPA receives adverse comment by March 12, 2007. If EPA receives
adverse comment, EPA will publish a timely withdrawal in the Federal
Register informing the public that the rule will not take effect. EPA
will address all public comments in a subsequent final rule based on
the proposed rule. EPA will not institute a second comment period on
this action. Any parties interested in commenting must do so at this
time. Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule,

EPA may adopt as final those provisions of the rule that are not the
subject of an adverse comment.

IV. Statutory and Executive Order Reviews

A. General Requirements

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This action
merely approves state law as meeting Federal requirements and imposes
no additional requirements beyond those imposed by state law.
Accordingly, the Administrator certifies that this rule will not have a
significant economic impact on a substantial number of small entities
under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because
this rule approves pre-existing requirements under state law and does
not impose any additional enforceable duty beyond that required by
state law, it does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4). This rule also does not
have tribal implications because it will not have a substantial direct
effect on one or more Indian tribes, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes,
as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
This action also does not have Federalism implications because it does
not have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government,
as specified in Executive Order 13132 (64 FR 43255, August 10, 1999).
This action merely approves a state rule implementing a Federal
requirement, and does not alter the relationship or the distribution of
power and responsibilities established in the Clean Air Act. This rule
also is not subject to Executive Order 13045 ``Protection of Children
from Environmental Health Risks and Safety Risks'' (62 FR 19885, April
23, 1997), because it approves a state rule implementing a Federal
standard.
    In reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act. In
this context, in the absence of a prior existing requirement for the
State to use voluntary consensus standards (VCS), EPA has no authority
to disapprove a SIP submission for failure to use VCS. It would thus be
inconsistent with applicable law for EPA, when it reviews a SIP
submission, to use VCS in place of a SIP submission that otherwise
satisfies the provisions of the Clean Air Act. Thus, the requirements
of section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not
impose an information collection burden under the provisions of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

B. Submission to Congress and the Comptroller General

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

C. Petitions for Judicial Review

    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by April 9, 2007. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action. This action may not be challenged later in proceedings
to enforce its requirements. (See section 307(b)(2).) EPA is approving
these amendments to West Virginia 45 CSR 13--Permits for Construction,
Modification, Relocation and Operation of Stationary sources of Air
Pollutants, Notification Requirements, Administrative Updates,
Temporary Permits, General Permits and Procedures for Evaluation as a
revision to the state's minor new source review program.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Nitrogen dioxide, Ozone, Particulate matter, Reporting and
recordkeeping requirements, Sulfur oxides, Volatile organic compounds.

     Dated: January 31, 2007.
James W. Newsom,
Acting Regional Administrator, Region III.

0
40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for 40 CFR part 52 continues to read as
follows:

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

Subpart XX--West Virginia

0
2. In Sec.  52.2520, the table in paragraph (c) is amended by revising
the entry 45 CSR 13 to read as follows:

Sec.  52.2520  Identification of plan.

* * * * *
    (c) * * *

                                                    EPA-Approved Regulations in the West Virginia SIP
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                State
State citation [Chapter 16-20 or                 Title/subject                  effective         EPA approval date           Additional explanation/
             45 CSR]                                                               date                                      citation at 40 CFR 52.2565
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     45 CSR 13 Permits for Construction, Modification, Relocation and Operation of Stationary Sources of Air Pollutants, Notification Requirements,
                               Administrative Updates, Temporary Permits, General Permits, and Procedures for Evaluation

                                                                      * * * * * * *
Section 45-13-1.................  General....................................      6/01/03  2/08/07 [Insert page number
                                                                                where the document begins]
Section 45-13-2.................  Definitions................................      6/01/03  2/08/07 [Insert page number
                                                                                where the document begins]
Section 45-13-3.................  Reporting Requirements for Stationary            6/01/03  2/08/07 [Insert page number
                                   Sources.                                                  where the document begins]
Section 45-13-4.................  Administrative Updates to Existing Permits       6/01/03  2/08/07 [Insert page number    Section Title Changed.
                                   and General Permit Registrations.                         where the document begins]
Section 45-13-5.................  Permit Application and Reporting                 6/01/03  2/08/07 [Insert page number
                                   Requirements for Construction of and                      where the document begins]
                                   Modifications to Stationary Sources.
Section 45-13-6.................  Determination of Compliance of Stationary        6/01/03  2/08/07 Insert page number
                                   Sources.                                                  where the document begins]
Section 45-13-7.................  Modeling...................................      6/01/03  2/08/07 Insert page number
                                                                                where the document begins]
Section 45-13-8.................  Public Review Procedures...................      6/01/03  2/08/07 Insert page number
                                                                                where the document begins]
Section 45-13-9.................  Public Meetings............................      6/01/03  2/08/07 [Insert page number
                                                                                where the document begins]
Section 45-13-10................  Permit Transfer, Suspension, Revocation and      6/01/03  2/08/07 [Insert page number
                                   Responsibility.                                           where the document begins]
Section 45-13-11................  Temporary Construction or Modification           6/01/03  2/08/07 [Insert page number
                                   Permits.                                                  where the document begins]
Section 45-13-12................  Permit Application Fees....................      6/01/03  2/08/07 [Insert page number
                                                                                where the document begins]
Section 45-13-13................  Inconsistency Between Rules................      6/01/03  2/08/07 [Insert page number
                                                                                where the document begins]
Section 45-13-14................  Statutory Air Pollution....................      6/01/03  2/08/07 [Insert page number
                                                                                where the document begins]
Section 45-13-15................  Hazardous Air Pollutants...................      6/01/03  2/08/07 [Insert page number
                                                                                where the document begins]
Table 45-13A....................  Potential Emission Rate....................      6/01/00  2/28/03, 68 FR 9559            (c)(52).
Table 45-13B....................  De Minimis Sources.........................      6/01/03  2/08/07 [Insert page number    Table Title Change.
                                                                                where the document begins]

                                                                      * * * * * * *
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* * * * *
[FR Doc. E7-2126 Filed 2-7-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 3 (Wednesday, January 6, 2016)]
[Notices]
[Pages 489-491]
[FR Doc No: 2015-33261]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-4952]

Food and Drug Administration Safety and Innovation Act 907 Public
Meeting: Progress on Enhancing the Collection, Analysis, and
Availability of Demographic Subgroup Data; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration's (FDA or Agency) Office of
Minority Health (OMH), Office of Women's Health (OWH), the Center for
Biologics Evaluation and Research (CBER), the Center for Drug
Evaluation and Research (CDER), and the Center for Devices and
Radiological Health (CDRH)

are announcing a public meeting seeking feedback and recommendations
from patient groups, consumer groups, regulated industry, academia, and
other interested parties on FDA's progress in implementing the ``Action
Plan to Enhance the Collection and Availability of Demographic Subgroup
Data,'' required under the Food and Drug Administration Safety and
Innovation Act (FDASIA).

DATES: The public meeting will be held on February 29, 2016, from 9
a.m. to 4 p.m. The deadline for submitting comments regarding this
meeting is April 29, 2016.

ADDRESSES: The public meeting will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Building 31 Conference Center, the Great Room
(B & C), Silver Spring, MD 20993-0002. Entrance for the public meeting
participants (non-FDA employees) is through Building 1 where routine
security check procedures will be performed. For parking and security
information, please refer to: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2015-N-4952 for ``FDASIA 907 Public Meeting: Progress on Enhancing
the Collection, Analysis, and Availability of Demographic Subgroup
Data; Request for Comments.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management 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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    FDA will post the full agenda approximately 5 days before the
meeting at: http://www.fda.gov/ForHealthProfessionals/LearningActivities/ucm470074.htm.

FOR FURTHER INFORMATION CONTACT: Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD 20993-0002, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On July 9, 2012, the President signed FDASIA (Pub. L. 112-144) into
law. Section 907 of FDASIA directed FDA to publish and provide to
Congress a report ``addressing the extent to which clinical trial
participation and the inclusion of safety and effectiveness data by
demographic subgroups, including sex, age, race, and ethnicity, is
included in applications submitted to the Food and Drug
Administration.'' Section 907 of FDASIA also directed that 1 year after
the publication of the report FDA publish and provide to Congress an
action plan outlining ``recommendations for improving the completeness
and quality of analyses of data on demographic subgroups in summaries
of product safety and effectiveness data and in labeling; on the
inclusion of such data, or the lack of availability of such data, in
labeling; and on improving the public availability of such data to
patients, healthcare providers, and researchers'' and to indicate the
applicability of these recommendations to the types of medical products
addressed in section 907. To fulfill these directives, an FDA-wide
steering committee with representatives from CBER, CDER, CDRH, and the
Office of the Commissioner (OC) conducted a detailed assessment of the
72 new drug, biologic, and medical device applications the Agency
approved in 2011. In August 2013, FDA issued a report on the group's
findings entitled ``Collection, Analysis, and Availability of
Demographic Subgroup Data for FDA-Approved Medical Products.'' In
August 2014, FDA followed up with a report entitled ``FDA Action Plan
to Enhance the Collection and Availability of Demographic Subgroup
Data,'' which contained 27 action items divided up into three
overriding priorities: Data quality, subgroup participation, and data
transparency.

    The purpose of the public meeting is to report on FDA's progress
implementing the Action Plan, to discuss how stakeholders have been
affected by these changes, and to solicit feedback and recommendations
for further implementation from interested parties and stakeholders.
    Some questions we would like the public to comment on during the
meeting include:
    1. What approaches have been successful in addressing key barriers
to recruiting diverse clinical trial populations?
    2. What are your key limitations to conducting meaningful data
analysis of underrepresented groups?
    3. What have you learned about best practices for recruiting a
broad representation of subjects for clinical trials? Which practices
have been successful and why? Which have not and why?
    4. What communication strategies have you successfully used that
were also sensitive to the needs of underrepresented populations?
    5. What are potential methods FDA should consider using to
effectively communicate meaningful information on demographic analyses
to a diverse public?
    6. What are some of the actual or potential unintended consequences
of data transparency you have encountered related to reporting
demographic subgroup analysis?
    Stakeholders are invited to provide brief comments on these topics
during the public comment portion of the meeting, but are not limited
to discussing only the previous topics. Since the day-long meeting may
not provide enough time to fully address all of these issues, we
encourage interested groups to submit longer explanations and comments
to the docket.

II. Registration and Request for Oral Presentations

    FDA will try to accommodate all participant requests to speak;
however, the duration of comments may be limited by time constraints.
Those wishing to make oral presentations will be asked to send a brief
summary of their comments and registration information (including name,
title, firm name, address, telephone, email address, and fax number),
and should register by February 1, 2016, by emailing
<EMAIL_ADDRESS>    All other participants are asked to register online at: http://www.fda.gov/ForHealthProfessionals/LearningActivities/ucm470074.htm by
February 13, 2016, whether they plan to attend in person or listen to
the meeting on a live Webcast. Registration is free and will be on a
first-come, first-served basis. Onsite registration on the day of the
meeting will be based on space availability. Information on how to
access the Webcast will be posted approximately 5 days before the
meeting at: http://www.fda.gov/ForHealthProfessionals/LearningActivities/ucm470074.htm.
    If you need special accommodations due to a disability, please
contact<EMAIL_ADDRESS>at least 7 days in advance. Persons
attending the public meeting are advised that FDA is not responsible
for providing access to electrical outlets.

    Dated: December 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-33261 Filed 1-5-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 194 (Tuesday, October 10, 2023)]
[Proposed Rules]
[Pages 69891-69893]
[FR Doc No: 2023-22352]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2023-1990; Project Identifier AD-2023-00734-A]
RIN 2120-AA64

Airworthiness Directives; Various Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for various airplanes modified with a certain configuration of the
Garmin GFC 500 Autopilot System installed per Supplemental Type
Certificate (STC) No. SA01866WI. This proposed AD was prompted by a
report of an un-commanded automatic pitch trim runaway when the
autopilot was first engaged. This proposed AD would require updating
the applicable Garmin GFC 500 Autopilot System software for your
airplane and would prohibit installing earlier versions of that
software. The FAA is proposing this AD to address the unsafe condition
on these products.

DATES: The FAA must receive comments on this proposed AD by November
24, 2023.

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 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: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    AD Docket: You may examine the AD docket at regulations.gov by
searching for and locating Docket No. FAA-2023-1990; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this NPRM, any comments
received, and other information. The street address for Docket
Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Christopher Withers, Aviation Safety
Engineer, FAA, 1801 S Airport Road, Wichita, KS 67209; phone: (316)
946-4190; email: [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2023-1990; Project Identifier
AD-2023-00734-A'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
regulations.gov, including any personal information you provide. The
agency will also post a report summarizing each substantive verbal
contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to
Christopher Withers, Aviation Safety Engineer, FAA, 1801 S Airport
Road, Wichita, KS 67209. Any commentary that the FAA receives which is
not specifically designated as CBI will be placed in the public docket
for this rulemaking.

Background

    The FAA received a report of an incident involving a Textron
Aviation Inc. (type certificate previously held by Beech Aircraft
Corporation, Raytheon Aircraft Company, Hawker Beechcraft Corporation,
and Beechcraft Corporation) Model F33A Bonanza airplane having an un-
commanded automatic pitch trim runaway when the autopilot was first
engaged. The airplane was equipped with a Garmin GFC 500 Autopilot
System that included an optional GSA 28 pitch trim servo. The affected
Garmin GFC 500 Autopilot System includes G5, G3X Touch, or GI 275
software and was installed per STC No. SA01866WI using Master Drawing
List 005-01264-00, Revisions 1 through 76.
    The affected autopilot system software does not properly handle
certain hardware failures of the pitch trim servo. This could result in
an automatic un-commanded pitch trim runaway, and loss of control of
the airplane.
    An investigation by Garmin International and the National
Transportation Safety Board (NTSB) determined this condition could
exist on various Textron Aviation, Inc., Piper Aircraft, Inc.,
Commander Aircraft Corporation, Mooney International Corporation, and
DAHER AEROSPACE airplane models equipped with a Garmin GFC 500
Autopilot System that includes an optional GSA 28 pitch trim servo.

FAA's Determination

    The FAA is issuing this NPRM after determining that the unsafe
condition described previously is likely to exist or develop on other
products of the same type design.

Proposed AD Requirements in This NPRM

    This proposed AD would require updating the applicable Garmin GFC
500 Autopilot System software for your airplane and would prohibit
installing earlier versions of that software.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 5,900 airplanes of U.S. registry.
    The FAA estimates the following costs to comply with this proposed
AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
               Action                        Labor cost           Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
Update autopilot software...........  1 work-hour x $85 per                $0              $85         $501,500
                                       hour = $85.
----------------------------------------------------------------------------------------------------------------

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.
    The FAA is 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

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would 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.

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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:

Various Airplanes: Docket No. FAA-2023-1990; Project Identifier AD-
2023-00734-A.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by November 24, 2023.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all airplane models specified in Table 1 to
paragraph (c) of this AD, certificated in any category, having a
Garmin GFC 500 Autopilot System that includes an optional GSA 28
pitch trim servo installed per Supplemental Type Certificate No.
SA01866WI using Master Drawing List 005-01264-00, Revisions 1
through 76.

          Table 1 to Paragraph (c)--Applicable Airplane Models
------------------------------------------------------------------------
        Type certificate holder                   Airplane model
------------------------------------------------------------------------
Commander Aircraft Corporation.........  112 and 114.
DAHER AEROSPACE........................  TB 20 and TB 21.
Mooney International Corporation.......  M20.
Piper Aircraft, Inc....................  PA-24.
Piper Aircraft, Inc....................  PA-28-150, PA-28-151, PA-28-
                                          160, PA-28-161, PA-28-235, PA-
                                          28R-180, PA-28R-200, PA-28R-
                                          201, PA-28R-201T, PA-28RT-201,
                                          and PA-28RT-201T.
Piper Aircraft, Inc....................  PA-32-260, PA-32-300, PA-32-
                                          301, PA-32-301FT, PA-32-301T,
                                          PA-32-301XTC, PA-32R-300, PA-
                                          32RT-300, PA-32RT-300T, PA-32R-
                                          301 (HP), PA-32R-301 (SP), and
                                          PA-32R-301T.
Textron Aviation Inc. (type certificate  B19, B23, and B24R.
 previously held by Beech Aircraft
 Corporation, Raytheon Aircraft
 Company, Hawker Beechcraft
 Corporation, and Beechcraft
 Corporation).
Textron Aviation Inc. (type certificate  C35, D35, E35, F35, and G35.
 previously held by Beech Aircraft
 Corporation, Raytheon Aircraft
 Company, Hawker Beechcraft
 Corporation, and Beechcraft
 Corporation).
Textron Aviation Inc. (type certificate  F33A, H35, J35, K35, M35, N35,
 previously held by Beech Aircraft        P35, S35, V35, 36, A36, and
 Corporation, Raytheon Aircraft           B36TC.
 Company, Hawker Beechcraft
 Corporation, and Beechcraft
 Corporation).
Textron Aviation Inc. (type certificate  172.
 previously held by Cessna Aircraft
 Company).
Textron Aviation Inc. (type certificate  172RG.
 previously held by Cessna Aircraft
 Company).
Textron Aviation Inc. (type certificate  177.
 previously held by Cessna Aircraft
 Company).
Textron Aviation Inc. (type certificate  182, 182G, and 182R.
 previously held by Cessna Aircraft
 Company).

Textron Aviation Inc. (type certificate  206.
 previously held by Cessna Aircraft
 Company).
Textron Aviation Inc. (type certificate  210.
 previously held by Cessna Aircraft
 Company).
------------------------------------------------------------------------

(d) Subject

    Joint Aircraft System Component (JASC) Code 2210, Autopilot
System.

(e) Unsafe Condition

    This AD was prompted by a report of an un-commanded automatic
pitch trim runaway when the autopilot was first engaged. The FAA is
issuing this AD to address autopilot software that does not properly
handle certain hardware failures of the pitch trim servo. The unsafe
condition, if not addressed, could result in un-commanded automatic
pitch trim runaway and loss of control of the airplane.

(f) Compliance

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

(g) Required Action

    Within 12 months after the effective date of this AD, update the
Garmin GFC 500 Autopilot System software applicable to your airplane
to a version that is not 8.01 or earlier for the G5, not version
9.01 or earlier for the G3X Touch, and not version 2.59 or earlier
for the GI 275.

(h) Installation Prohibition

    As of the effective date of this AD, do not install Garmin GFC
500 Autopilot System Software that is version 8.01 or earlier for
the G5, version 9.01 or earlier for the G3X Touch, or version 2.59
or earlier for the GI 275, on any airplane.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Central Certification Branch, 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 Central Certification Branch, send it
to the attention of the person identified in paragraph (j) of this
AD. Information may be emailed to [email protected].
    (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.

(j) Related Information

    For more information about this AD, contact Christopher Withers,
Aviation Safety Engineer, FAA, 1801 S Airport Road, Wichita, KS
67209; phone:<PHONE_NUMBER>; email: [email protected].

(k) Material Incorporated by Reference

    None.

    Issued on October 3, 2023.
Victor Wicklund,
Deputy Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-22352 Filed 10-6-23; 8:45 am]
BILLING CODE 4910-13-P