[Federal Register Volume 83, Number 150 (Friday, August 3, 2018)]
[Proposed Rules]
[Pages 38086-38088]
[FR Doc No: 2018-16515]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0633; Product Identifier 2018-NE-22-AD]
RIN 2120-AA64

Airworthiness Directives; General Electric Company Turbofan
Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain General Electric Company (GE) GEnx-2B67, -2B67B, and -2B67/P
turbofan engines. This proposed AD was prompted by low-cycle fatigue
(LCF) cracking of the fuel manifold leading to an engine fire. This
proposed AD would require removal from service of certain fuel
manifolds at the next engine shop visit and their replacement with
parts eligible for installation. We are proposing this AD to address
the unsafe condition on these products.

DATES: We must receive comments on this proposed AD by September 17,
2018.

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: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact General
Electric Company, GE Aviation, Room 285, 1 Neumann Way, Cincinnati, OH
45215; phone:<PHONE_NUMBER>; email: [email protected]. You may view this
service information at the FAA, Engine and Propeller Standards Branch,
1200 District Avenue, Burlington, MA 01803. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0633; 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, the regulatory evaluation, any comments received, and other
information. The street address for Docket Operations (phone: 800-647-
5527) is listed above. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Herman Mak, Aerospace Engineer, ECO
Branch, FAA, 1200 District Ave., Burlington, MA 01803; phone: 781-238-
7147; fax:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2018-0633;
Product Identifier 2018-NE-22-AD'' at the beginning of your comments.
We specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this NPRM. We will consider all
comments received by the closing date and may amend this NPRM 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 NPRM.

Discussion

    We received information concerning a fire in the under-cowl
compartment of a GE GEnx-2B turbofan engine. Insufficient bushing
clearance in the fuel manifold bracket resulted in additional fuel
manifold loads, premature manifold cracking, fuel leakage, and fuel
ignition. Twelve fuel manifolds were found to have LCF cracks. Three of
these twelve cracked fuel manifolds resulted in a fire. This condition,
if not addressed, could result in failure of the fuel manifold, engine
fire, and damage to the airplane.

Related Service Information

    We reviewed GE GEnx-2B Service Bulletin (SB) 73-0038 R02, dated
November 19, 2015. The SB describes procedures for removing and
replacing the fuel manifold system with parts eligible for
installation.

FAA's Determination

    We are proposing 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.

Proposed AD Requirements

    This proposed AD would require removal from service of certain fuel
manifolds at the next engine shop visit and their replacement with
parts eligible for installation.

Costs of Compliance

    We estimate that this proposed AD affects two engines installed on
airplanes of U.S. registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
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                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Replace fuel manifolds................  220 work-hours x $85 per        $119,485        $138,185        $276,370
                                         hour = $18,700.
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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.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to engines, propellers, and
associated appliances to the Manager, Engine and Propeller Standards
Branch, Policy and Innovation Division.

Regulatory Findings

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

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 (AD):

General Electric Company: Docket No. FAA-2018-0633; Product
Identifier 2018-NE-22-AD.

(a) Comments Due Date

    We must receive comments by September 17, 2018.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to General Electric Company (GE) GEnx-2B67, -
2B67B, and -2B67/P turbofan engines with top main fuel manifolds,
part numbers (P/Ns) 2419M11G01, 2561M11G01, or 2546M11G01, or lower
fuel manifolds, P/Ns 2419M12G01, 2561M12G01, or 2546M12G01,
installed.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7310, Engine Fuel
Distribution.

(e) Unsafe Condition

    This AD was prompted by low-cycle fatigue cracking of the fuel
manifold leading to an engine fire. We are issuing this AD to
prevent the failure of the fuel manifold. The unsafe condition, if
not addressed, could result in failure of the fuel manifold, engine
fire, and damage to the airplane.

(f) Compliance

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

(g) Required Actions

    At the next engine shop visit, remove the applicable fuel
manifolds from service and replace with parts eligible for
installation.

(h) Installation Prohibition

    After the effective date of this AD, do not install top main
fuel manifolds, P/Ns 2419M11G01, 2561M11G01, or 2546M11G01, or lower
fuel manifolds, P/Ns 2419M12G01, 2561M12G01, or 2546M12G01.

(i) Definition

    For the purpose of this AD, an ``engine shop visit'' is the
induction of an engine into the shop for maintenance involving the
separation of pairs of major mating engine case flanges, except for
the following situations, which do not constitute an engine shop
visit:
    (1) Separation of engine flanges solely for the purposes of
transportation of the engine without subsequent maintenance.
    (2) Separation of engine flanges solely for the purposes of
replacing the fan or propulsor without subsequent maintenance.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, ECO 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
certification office, send it to the attention of the person
identified in paragraph (k)(1) 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.

(k) Related Information

    (1) For more information about this AD, contact Herman Mak,
Aerospace Engineer, ECO Branch, FAA, 1200 District Ave., Burlington,
MA 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
[email protected].
    (2) For service information identified in this AD, contact
General Electric Company, GE Aviation, Room 285, 1 Neumann Way,
Cincinnati, OH 45215; phone:<PHONE_NUMBER>; email: [email protected].
You may view this referenced service information at the FAA, Engine
and Propeller Standards Branch, 1200 District Avenue, Burlington, MA
01803. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

    Issued in Burlington, Massachusetts, on July 27, 2018.
Karen M. Grant,
Acting Manager, Engine and Propeller Standards Branch, Aircraft
Certification Service.
[FR Doc. 2018-16515 Filed 8-2-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 243 (Monday, December 19, 2016)]
[Proposed Rules]
[Pages 91895-91898]
[FR Doc No: 2016-30327]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2015-0621; FRL-9956-96-Region 9]

Revisions to the California State Implementation Plan; Imperial
County Air Pollution Control District; Stationary Sources Permits

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing action
on revisions to the Imperial County Air Pollution Control District
(ICAPCD or District) portion of the California State Implementation
Plan (SIP). We are proposing full approval of two rules and a limited
approval and limited disapproval of one rule. All three rules update
and revise the District's New Source Review (NSR) permitting program
for new and modified sources of air pollution. We are taking comments
on this proposal and plan to follow with a final action.

DATES: Any comments must arrive by January 18, 2017.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2015-0621 at http://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov, follow
the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, the EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. The EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Laura Yannayon, EPA Region IX, (415)
972-3534<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA.

Table of Contents

Definitions
I. The State's Submittal
    A. What rules did the State submit?
    B. Are there other versions of these rules?
    C. What is the purpose of the submitted rules?
II. EPA's Evaluation and Action
    A. How is EPA evaluating the rules?
    B. Do the rules meet the evaluation criteria?
    C. Public Comment and Proposed Action
III. Incorporation by Reference
IV. Statutory and Executive Order Reviews

Definitions

    For the purpose of this document, we are giving meaning to certain
words or initials as follows:
    (i) The word or initials Act or CAA mean or refer to the Clean Air
Act, unless the context indicates otherwise.
    (ii) The initials CARB mean or refer to the California Air
Resources Board.
    (iii) The initials CFR mean or refer to Code of Federal
Regulations.
    (iv) The initials or words EPA, we, us or our mean or refer to the
United States Environmental Protection Agency.
    (v) The initials FR mean or refer to Federal Register.
    (vi) The word or initials ICAPCD or District mean or refer to the
Imperial County Air Pollution Control District, the agency with
jurisdiction over stationary sources within Imperial County.

    (vii) The initials NAAQS mean or refer to National Ambient Air
Quality Standards.
    (viii) The initials NSR mean or refer to New Source Review.
    (ix) The initials PM10 mean or refer to particulate
matter with an aerodynamic diameter of less than or equal to 10
micrometers (coarse particulate matter).
    (x) The initials PM2.5 mean or refer to particulate
matter with an aerodynamic diameter of less than or equal to 2.5
micrometers (fine particulate matter).
    (xi) The initials SIP mean or refer to State Implementation Plan.
    (xii) The initials TSD mean or refer to the technical support
document for this action.

I. The State's Submittal

A. What rules did the State submit?

    Table 1 lists the rules addressed by this proposal, including the
dates they were adopted by ICAPCD and submitted by CARB, which is the
governor's designee for California SIP submittals.

                                            Table 1--Submitted Rules
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            Local agency                 Rule No.            Rule title        Adopted/revised      Submitted
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ICAPCD.............................               204  Applications.........           9/14/99          05/26/00
ICAPCD.............................               206  Processing of                  10/22/13          02/10/14
                                                        Applications.
ICAPCD.............................               207  New and Modified               10/22/13           1/21/14
                                                        Stationary Source
                                                        Review.
----------------------------------------------------------------------------------------------------------------

    On April 9, 2014 and March 7, 2014, EPA determined that the
submittals for ICAPCD Rules 206 and 207, respectively, met the
completeness criteria in 40 CFR part 51 Appendix V. The submittal for
ICAPCD Rule 204 was deemed by operation of law to meet the completeness
criteria in 40 CFR part 51 Appendix V as of October 6, 2000. The
completeness criteria in 40 CFR part 51, Appendix V must be met before
formal EPA review.

B. Are there other versions of these rules?

    There is no previous version of Rule 204 in the SIP; EPA approved
previous versions of Rules 206 and 207 into the SIP on January 3, 2007
(72 FR 9) and November 10, 1980 (45 FR 74480), respectively.\1\ Section
D.1.a of submitted Rule 207 is contained in SIP-approved Rule 209
(Implementation Plans), which was also approved on November 10,
1980.\2\
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    \1\ EPA disapproved subparagraph C.5 of SIP-approved Rule 207
because it exempted some sources from the requirement to apply LAER.
See 40 CFR 52.233(a)(1).
    \2\ EPA's approval of Rule 206 would supersede our prior
approval of Rule 206 in the SIP. Likewise, approval of Rule 207
would supersede our prior approval of SIP-approved Rules 207 and 209
and will supersede our prior disapproval of Rule 207, subparagraph
C.5 and our Part D conditional approval. We intend to make
conforming changes to the regulatory text codified in 40 CFR 52.220,
40 CFR 52.232 and 40 CFR 52.233.
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C. What is the purpose of the submitted rules?

    Section 110(a) of the CAA requires states to submit regulations
that include a pre-construction permit program for certain new or
modified stationary sources of pollutants, including a permit program
as required by Part D of Title I of the CAA.
    The purpose of District Rule 204 (Applications), Rule 206
(Processing of Applications) and Rule 207 (New and Modified Stationary
Source Review) is to implement a federal preconstruction permit program
for new and modified minor sources of criteria pollutants and new and
modified major sources of criteria pollutants for which the area is
designated nonattainment. Imperial County is currently designated as a
moderate nonattainment area for the 2008 8-hr ozone NAAQS.\3\ Portions
of the county are designated as a serious nonattainment area for the
1987 24-hr PM10 NAAQS, as a moderate nonattainment area for
the 2006 24-hr PM2.5 NAAQS and as a moderate nonattainment
area for the 2012 annual PM2.5 NAAQS. We present our
evaluation under the CAA and EPA's regulations of the amended NSR rules
submitted by CARB, as identified in Table 1 and provide our reasoning
in general terms below and a more detailed analysis in our TSD, which
is available in the docket for this proposed rulemaking.
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    \3\ Effective March 14, 2008 (73 FR 8209, February 13, 2008),
the EPA reclassified Imperial County to a moderate ozone
nonattainment area for the 1997 ozone NAAQS. In 2012, EPA designated
Imperial County as a nonattainment area for the 2008 ozone NAAQS and
classified the area as marginal. 77 FR 30088 (May 21, 2012). The SIP
submittal that EPA is now evaluating via this proposal addresses the
NNSR requirement for the Imperial County ozone nonattainment area
for a moderate classification under the 1997 ozone NAAQS as well as
a marginal classification under the 2008 ozone NAAQS.
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II. EPA's Evaluation and Action

A. How is EPA evaluating the rules?

    The submitted rules must meet the CAA's general requirements for
SIPs and SIP revisions in CAA sections 110(a)(2), 110(l), and 193, as
well as the applicable requirements contained in part D of title I of
the Act (sections 172, and 173) for a nonattainment NSR permit program.
In addition, the submitted rules must contain the applicable regulatory
provisions of 40 CFR 51.160-51.165 and 40 CFR 51.307.
    Among other things, section 110 of the Act requires that SIP rules
be enforceable and provides that EPA may not approve a SIP revision if
it would interfere with any applicable requirements concerning
attainment and reasonable further progress or any other requirement of
the CAA. In addition, section 110(a)(2) and section 110(l) of the Act
require that each SIP or revision to a SIP submitted by a state must be
adopted after reasonable notice and public hearing.
    Section 110(a)(2)(c) of the Act requires each SIP to include a
permit program to regulate the modification and construction of any
stationary source within the areas covered by the SIP as necessary to
assure attainment and maintenance of the NAAQS. EPA's regulations at 40
CFR 51.160-51.164 provide general programmatic requirements to
implement this statutory mandate commonly referred to as the ``minor
NSR'' or ``general NSR'' permit program. These NSR program regulations
impose requirements for SIP approval of state and local programs that
are more general in nature as compared to the specific statutory and
regulatory requirements for nonattainment NSR permitting programs under
Part D of title I of the Act.
    Part D of title I of the Act contains the general requirements for
areas designated nonattainment for a NAAQS (section 172), including
preconstruction permit requirements for new major sources and major
modifications proposing to construct in nonattainment areas (section
173).
    Part D of title I of the Act also includes section 182(b), which
contains the additional requirements for areas designated as a moderate
ozone nonattainment area, and section 189(e), which requires the
control of major stationary sources of PM10 precursors (and
hence PM2.5 precursors) ``except

where the Administrator determines that such sources do not contribute
significantly to PM10 [and PM2.5] levels which
exceed the standard in the area.'' Additionally, 40 CFR 51.165 sets
forth EPA's regulatory requirements for SIP-approval of a nonattainment
NSR permit program.
    The protection of visibility requirements that apply to New Source
Review programs are contained in 40 CFR 51.307. This provision requires
that certain actions be taken in consultation with the local Federal
Land Manager if a new major source or major modification may have an
impact on visibility in any mandatory Class I Federal Area.
    Section 110(l) of the Act prohibits EPA from approving any SIP
revisions that would interfere with any applicable requirement
concerning attainment and reasonable further progress (RFP) or any
other applicable requirement of the CAA. Section 193 of the Act, which
only applies in nonattainment areas, prohibits the modification of a
SIP-approved control requirement in effect before November 15, 1990, in
any manner unless the modification insures equivalent or greater
emission reductions of such air pollutant.
    Our TSD, which can be found in the docket for this rule, contains a
more detailed discussion of the approval criteria.

B. Do the rules meet the evaluation criteria?

    EPA has reviewed the submitted rules in accordance with the rule
evaluation criteria described above. With respect to procedures, based
on our review of the public process documentation included in the May
26, 2000, January 21, 2014, and February 10, 2014 submittals, we are
proposing to approve the submitted rules in part because we have
determined that ICAPCD has provided sufficient evidence of public
notice and opportunity for comment and public hearings prior to
adoption and submittal of these rules, in accordance with the
requirements of CAA sections 110(a)(2) and 110(l).
    With respect to substantive requirements, we have reviewed the
submitted rules in accordance with evaluation criteria discussed above.
We are proposing to approve Rules 204 and 206 as part of ICAPCD's
general NSR permitting program because we have determined that these
rules, together with Rule 207, satisfy the substantive statutory and
regulatory requirements for a general NSR permit program as contained
in CAA section 110(a)(2)(c) and 40 CFR 51.160-51.164.
    In addition, we are proposing a limited approval/limited
disapproval of Rule 207. We are proposing a limited approval because we
have determined that Rule 207 (i) satisfies the statutory and
regulatory requirements for a general NSR permit program as set forth
in CAA section 110(a)(2)(c) and 40 CFR 51.160-51.164; and (ii) mostly
satisfies the statutory and regulatory requirements for a nonattainment
NSR permit program for moderate ozone, serious PM10, and
moderate PM2.5 nonattainment areas as set forth in the
applicable provisions of part D of title I of the Act (sections 172 and
173) and in 40 CFR 51.165 and 40 CFR 51.307. We are also proposing a
limited disapproval of Rule 207 because we have determined that the
rule does not regulate ammonia as a PM2.5 precursor
consistent with the requirements of 40 CFR 51.165(a)(13). While the
District provided a demonstration to support their contention that
ammonia is a not a significant contributor to the areas
PM2.5 nonattainment status, the demonstration was not
consistent with EPA's newly promulgated nonattainment NSR precursor
demonstration requirements as set forth in 40 CFR 51.1006(a)(3). Our
TSD contains a more detailed discussion of this disapproval issue.
    EPA is also proposing to find that it is acceptable for ICAPCD to
not incorporate the NSR Reform provisions of 40 CFR 51.165 into its NSR
permit program because ICAPCD's permitting program will not be any less
stringent than the federal permitting program.
    In addition, EPA is proposing to find that Rules 204, 206 and 207
meet the statutory requirements for SIP revisions as specified in
sections 110(l) and 193 of the CAA.
    Please see our TSD for more information regarding our evaluation of
Rules 204, 206 and 207.

C. Public Comment and Proposed Action

    As authorized by CAA section 110(k)(3) and 301(a), we are proposing
approval of Rule 204 (Applications) and Rule 206 (Processing of
Applications), and we are proposing limited approval of Rule 207 (New
and Modified Stationary Source Review) into the ICAPCD portion of the
California SIP. If finalized, this action would incorporate the
submitted rules into the SIP, including those provisions identified as
deficient. The approval of Rule 207 is limited because EPA is
simultaneously proposing a limited disapproval of Rule 207 under
section 110(k)(3). If finalized, this disapproval would trigger the
two-year clock for the federal implementation plan (FIP) requirement
under section 110(c). In addition, final disapproval would trigger
sanctions under CAA section 179 and 40 CFR 52.31 unless the EPA
approves subsequent SIP revisions that correct the rule deficiencies
within 18 months of the effective date of the final action.
    We will accept comments from the public on the proposed approvals
of Rules 204 and 206 and the proposed limited approval and limited
disapproval of Rule 207 for the next 30 days.
    In today's action we are also notifying the public that we intend
to make a technical correction to our previous action approving Rule
202--Exemptions into the ICAPCD portion of the California SIP.\4\ In
that action we stated that approval of Rule 202 into the SIP would
supersede and remove Rule 103--Exemptions, which EPA has previously
approved on May 31, 1972 (37 FR 10832), but we failed to include the
necessary regulatory text to effect this change. Our final rulemaking
for our action on Rules 204, 206 and 207 will include the necessary
regulatory text to remove Rule 103 from the California SIP. We are not
seeking public comment on this technical correction because public
participation requirements were satisfied as part of our action
approving Rule 202 into the SIP.
---------------------------------------------------------------------------

    \4\ 76 FR 26615 (May 9, 2011).
---------------------------------------------------------------------------

III. Incorporation by Reference

    In this rule, the EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by
reference the ICAPCD rules listed in Table 1 of this notice. The EPA
has made, and will continue to make, these documents generally
available electronically through www.regulations.gov and in hard copy
at the appropriate EPA office (see the ADDRESSES section of this
preamble for more information).

IV. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was
therefore not

submitted to the Office of Management and Budget (OMB) for review.

B. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under
the PRA because this action does not impose additional requirements
beyond those imposed by state law.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. This
action will not impose any requirements on small entities beyond those
imposed by state law.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. This action does not impose additional requirements
beyond those imposed by state law. Accordingly, no additional costs to
State, local, or tribal governments, or to the private sector, will
result from this action.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will 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.

F. Executive Order 13175: Coordination With Indian Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175, because the SIP is not approved to apply on any
Indian reservation land or in any other area where the EPA or an Indian
tribe has demonstrated that a tribe has jurisdiction, and will not
impose substantial direct costs on tribal governments or preempt tribal
law. Thus, Executive Order 13175 does not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that the EPA has reason to believe may disproportionately affect
children, per the definition of ``covered regulatory action'' in
section 2-202 of the Executive Order. This action is not subject to
Executive Order 13045 because it does not impose additional
requirements beyond those imposed by state law.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This action is not subject to Executive Order 13211, because it is
not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    Section 12(d) of the NTTAA directs the EPA to use voluntary
consensus standards in its regulatory activities unless to do so would
be inconsistent with applicable law or otherwise impractical. The EPA
believes that this action is not subject to the requirements of section
12(d) of the NTTAA because application of those requirements would be
inconsistent with the CAA.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Population

    The EPA lacks the discretionary authority to address environmental
justice in this rulemaking.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, New Source Review, Ozone,
Particulate matter, Reporting and recordkeeping requirements, Volatile
organic compounds.

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

    Dated: December 8, 2016.
Alexis Strauss,
Acting Regional Administrator, Region IX.
[FR Doc. 2016-30327 Filed 12-16-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: March 25, 2010 (Volume 75, Number 57)]
[Proposed Rules]
[Page 14385-14386]
[DOCID:fr25mr10-20]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2010-0001; Airspace Docket No. 10-ASO-10]

Revocation of Class D and E Airspace; Panama City, FL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action would remove Class D and Class E airspace areas at
Panama City-Bay County Airport, Panama City, FL, as the old airport and
control tower is scheduled to be closed. Controlled airspace will be
established for the new airport under separate rulemaking.

DATES: Comments must be received on or before May 10, 2010.

ADDRESSES: Send comments on this rule to: U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590-0001;
Telephone: 1-800-647-5527; Fax:<PHONE_NUMBER>. You must identify the
Docket Number FAA-2010-0001; Airspace Docket No. 10-ASO-10, at the
beginning of your comments. You may also submit and review received
comments through the Internet at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Melinda Giddens, Airspace Specialist,
Operations Support Group, Eastern Service Center, Air Traffic
Organization, Federal Aviation Administration, P.O. Box 20636, Atlanta,
Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested persons are invited to comment on this rule by
submitting such written data, views, or arguments, as they may desire.
Comments that provide the factual basis supporting the views and
suggestions presented are particularly helpful in developing reasoned
regulatory decisions on the proposal. Comments are specifically invited
on the overall regulatory, aeronautical, economic, environmental, and
energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2010-0001 and Airspace Docket No. 10-ASO-10) and be submitted in
triplicate to the Docket Management System (see ADDRESSES section for
address and phone number). You may also submit comments through the
Internet at http://222.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to Docket
No. FAA-2010-0001; Airspace Docket No. 10-ASO-10.'' The postcard will
be date/time stamped and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded from and
comments submitted through http://www.regulations.gov. Recently
published rulemaking documents can also be accessed through the FAA's
web page at http://www.faa.gov/airports_airtraffic/air_traffic/
publications/airspace_amendments/.
    You may review the public docket containing the rule, any comments
received, and any final disposition in person in the Dockets Office
(see ADDRESSES section for address and phone number) between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. An informal
docket may also be examined during normal business hours at the office
of the Eastern Service Center, Federal Aviation Administration, Room
210, 1701 Columbia Avenue, College Park, Georgia 30337.
    Persons interested in being placed on a mailing list for future
NPRM's should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>,
to request a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    The FAA is considering an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 to remove Class D and E airspace at Panama
City-Bay County Airport, Panama City, FL. Panama City-Bay County
Airport is closing to allow establishment of controlled airspace at the
new airport, which is being proposed under separate rulemaking. Also,
Class E airspace for Tyndall AFB would be re-established under separate
rulemaking.
    Class D airspace designations, Class E airspace designations as
extensions to a Class D surface area (E4), and Class E5 designations
are published in Paragraphs 5000, 6004 and 6005, respectively, of FAA
Order 7400.9T, signed August 27, 2009, and effective September 15,
2009, which is incorporated by reference in 14 CFR 71.1. The Class D
and E airspace designations listed in this document would be published
subsequently in the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This proposed rulemaking is promulgated under the authority
described in Subtitle VII, Part, A, Subpart I, Section 40103. Under
that section, the FAA is charged with

prescribing regulations to assign the use of airspace necessary to
ensure the safety of aircraft and the efficient use of airspace. This
proposed regulation is within the scope of that authority as it
proposes to remove Class D and E airspace at Panama City-Bay County
Airport, Panama City, FL.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR Part 71 as follows:

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

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

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

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of Federal
Aviation Administration Order 7400.9T, Airspace Designations and
Reporting Points, signed August 27, 2009, and effective September 15,
2009, is amended as follows:

Paragraph 5000 Class D Airspace.

* * * * *

ASO FL D Panama City, FL [Removed]

* * * * *

Paragraph 6004 Class E Airspace Designated as an Extension to a
Class D Surface Area.

* * * * *

ASO FL E4 Panama City, FL [Removed]

* * * * *

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

* * * * *

ASO FL E5 Panama City, FL [Removed]

    Issued in College Park, Georgia, on March 17, 2010.
Michael Vermuth,
Acting Manager, Operations Support Group, Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2010-6665 Filed 3-24-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 95 (Thursday, May 18, 2017)]
[Rules and Regulations]
[Pages 22741-22742]
[FR Doc No: 2017-10036]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201, 801, and 1100

[Docket No. FDA-2015-N-2002]
RIN 0910-AH19

Clarification of When Products Made or Derived From Tobacco Are
Regulated as Drugs, Devices, or Combination Products; Amendments to
Regulations Regarding ``Intended Uses''; Further Delayed Effective
Date; Request for Comments; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; extension of comment period.

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

SUMMARY: In the Federal Register of January 9, 2017, the Food and Drug
Administration (FDA or the Agency) issued a final rule entitled
``Clarification of When Products Made or Derived From Tobacco Are
Regulated as Drugs, Devices, or Combination Products; Amendments to
Regulations Regarding `Intended Uses' '' (Final Rule). On March 20,
2017, FDA published a document in the Federal Register (Final Rule
Extension) to delay the effective date of the Final Rule until March
19, 2018, and requested comments on particular issues raised in a
petition for reconsideration and stay of action of the Final Rule. The
petition for reconsideration raised questions about the amendments to
the regulations regarding ``intended uses'' that are set forth in the
Final Rule. In the Final Rule Extension FDA also requested comments
regarding any aspect of the Final Rule, or with respect to issues
relating to ``intended uses'' generally, and on whether the delay in
the effective date should be modified or revoked. FDA is now issuing
this document to extend the comment period. The Agency is taking this
action in response to requests for an extension to allow interested
persons additional time to submit comments.

DATES: FDA is extending the comment period on the document delaying the
effective date and seeking comment on the final rule published March
20, 2017 (82 FR 14319). Submit either electronic or written comments by
July 18, 2017. For additional information on the comment date, see
ADDRESSES and SUPPLEMENTARY INFORMATION.

ADDRESSES: 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 July 18, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of July 18, 2017. 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): 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-2002 for ``Clarification of When Products Made or Derived
From Tobacco Are Regulated as Drugs, Devices, or Combination Products;
Amendments to Regulations Regarding `Intended Uses'; Further Delayed
Effective Date; Request for Comments; Extension of Comment Period.''
Received comments, those filed in a timely manner (see DATES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://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 https://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: 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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Robert Berlin, Office of Policy, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4238,
Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of March 20, 2017,
FDA published a document delaying the effective date of the January 9,
2017 (82 FR 2193), final rule entitled ``Clarification of When Products
Made or Derived From Tobacco Are Regulated as Drugs, Devices, or
Combination Products; Amendments to Regulations Regarding `Intended
Uses' '' until March 19, 2018, with a 60-day comment period. FDA
requested comments on particular issues raised in a petition for
reconsideration and stay of action of the Final Rule, as well as
regarding any aspect of the Final Rule, or with respect to issues
relating to ``intended uses'' generally. FDA also requested comments on
whether the delay in the effective date of the Final Rule should be
modified or revoked. Comments on these issues will inform FDA's
thinking and next steps on these issues.
    The Agency has received a request for a 30-day extension and
another request for a 90-day extension of the comment period for the
Final Rule Extension. The requests conveyed concern that the current
60-day comment period does not allow sufficient time to develop a
meaningful or thoughtful response to issues FDA raised in the Final
Rule Extension.
    FDA has considered the requests and is extending the comment period
for 60 days, until July 18, 2017. The Agency believes that a 60-day
extension allows additional time for interested persons to submit
comments on these important issues.

    Dated: May 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-10036 Filed 5-17-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 91 (Monday, May 12, 2014)]
[Notices]
[Pages 26974-26975]
[FR Doc No: 2014-10787]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0505]

Proteomics in the Clinic; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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

    The Food and Drug Administration (FDA) is announcing the following
public workshop entitled ``Proteomics in the Clinic.'' FDA seeks input
from interested stakeholders on how best to develop a regulatory
framework targeted toward the complex issues involved in transforming
research-level assays into validated in vitro diagnostics (IVDs) that
can be used with patients. The topic to be discussed is the state of
the art and challenges surrounding validation of proteomic
methodologies for IVD tests.

Date and Time: The public workshop will be held on June 13, 2014, from
8:30 a.m. to 5 p.m.
    Location: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the
Great Room (Rm. 1503), Silver Spring, MD 20993-0002. 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 http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Contact Person: Julia Tait Lathrop, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5564, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
email<EMAIL_ADDRESS>    Registration: Registration is free and available on a first-come,
first-served basis. Persons interested in attending this public
workshop must register online by 4 p.m. on June 4, 2014. Early
registration is recommended because facilities are limited and,
therefore, FDA may limit the number of participants from each
organization. If time and space permits, onsite registration on the day
of the public workshop will be provided beginning at 7:30 a.m.
    If you need special accommodations due to a disability, please
contact Susan Monahan, Center for Devices for Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, Rm. 4321,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>no later than 4 p.m. on May 30, 2014.
    To register for the public workshop, please visit FDA's Medical
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
(Select this public workshop from the posted events list.) Please
provide complete contact information for each attendee, including name,
title, affiliation, email, and telephone number. Those without Internet
access should contact Julia Tait Lathrop to register (see Contact
Person). Registrants will receive confirmation after they have been
accepted. You will be notified if you are on a waiting list.
    Streaming Webcast of the Public Workshop: This public workshop will
also be Webcast. Persons interested in viewing the Webcast must
register online by 4 p.m. on June 4, 2014. Early registration is
recommended because Webcast connections are limited. Organizations are
requested to register all participants, but to view using one
connection per location. Webcast participants will be sent technical
system requirements after registration and will be sent connection
access information after June 9, 2014. 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 http://www.adobe.com/go/connectpro_overview. (FDA has verified the Web site
addresses in this document, but FDA is not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)
    Comments: FDA is holding this public workshop to discuss with
interested stakeholders the issues surrounding validation of proteomic
methodologies for IVD tests. In order to permit the widest possible
opportunity to obtain public comment, FDA is soliciting either
electronic or written comments on all aspects of the workshop topics.
The deadline for submitting comments related to this public workshop is
July 11, 2014.
    Regardless of attendance at the public workshop, interested persons
may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. It is only necessary to send one set of
comments. Identify comments with the docket number found in brackets in
the heading of this document. In addition, when responding to specific
questions as outlined in section II of this document, please identify
the question you are addressing. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at http://www.regulations.gov.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management (see Comments). A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to the Division of Freedom of Information (ELEM-1029),
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857. A link to the transcripts will also be available
approximately 45 days after the public workshop on the Internet at
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list).

SUPPLEMENTARY INFORMATION:

I. Background

    Basic research in proteomics, the study of all of the proteins and
their interactions in an individual, has led to new understanding of
proteins' contributions to health and disease. It has also driven the
advancement of powerful analytical technologies used to explore these
contributions. Translating these discoveries and technologies into IVD
tests presents expanded opportunities to improve patient care; however,
the complexity of these technologies raises challenging questions on
how to evaluate the safety and effectiveness of these tests. FDA is
holding this public workshop to invite discussion with industry,
academia, government, and the public on how best to adapt current
regulatory strategies to the challenges presented by proteomic
approaches to IVDs, while still accelerating and supporting the
introduction of innovative diagnostic tests into the clinic.
    Over the past 20 years, basic proteomic research has spurred
intense innovation in biochemical analytic technologies (e.g., mass
spectrometry, multiplex arrays, bioinformatics). This research has led
to new insights into how proteins interact to maintain health and to
cause disease; however, it is only recently that these technologies
have

matured to the point that their introduction into the clinic appears
practical and useful. Fundamental to using IVDs in the clinic is the
need to demonstrate that the tests are safe and effective--that the
results claimed are accurate and precise and that the interpretation of
the results are supported by science. FDA's regulatory process is
designed to ensure that intended use claims are supported with
appropriate data. However, the range of variables that can be included
in proteomic IVDs such as technological approaches, variety of sample
types and preparation methods, data capture, and analysis algorithms,
poses unique regulatory challenges, as more complex the information
gathered, more challenging is the validation of results. At this point,
what we need is a regulatory framework, tuned to proteomic
technologies, which will facilitate the introduction of validated IVDs
into the clinic.
    The intent of this workshop is not to discuss the limitations and
strengths of the proteomic discovery process. The theoretical
analytical performance of proteomic technologies have been well
demonstrated, and in the past few years a number of initiatives have
been launched to bring standardization and quality control to the
discovery and pre-clinical development of proteomic-based assays.
However, this level of quality control does not ensure that these
assays have been validated for their intended use as IVDs tests that
are used for diagnosis of disease and clinical management of patients;
e.g., assessment of risk, monitoring of disease, prediction of response
to therapy, and selection of treatment.
    Strategies are needed that will guide the successful transfer of
research and discovery-level assays into the clinic. This includes
their use in clinical trials, so that the analytical and clinical
validity of the test procedure and outcome are assured. As a general
rule, the requirements for analytical and clinical validation of IVDs
are much greater than the studies that are commonly performed in a
research and development setting. To support the least burdensome
approach to assay development, FDA is willing to discuss unconventional
approaches to IVD validation driven by, for example, the theoretical
precision of multiple reaction monitoring assays. However, theoretical
performance must be balanced by the recognition that there are few, if
any, recognized reference standards for the analytes or the assays with
which to assess the performance of proteomic IVDs. The impact of the
lack of standards may be substantial: Assays that combine the
measurements of several, if not dozens, of individual analytes into a
single, actionable ``score'' may require validation of each individual
analyte separately and in combination. Thus, the objective of this
public workshop is to obtain feedback from academia, government,
industry, clinical laboratories, and other stakeholders on the
development of a regulatory approach that may reduce the burden of
assay validation while assuring that the assays are safe and effective.

II. Topics for Discussion at the Public Workshop

    We plan to include the following topics at the public workshop.
     State of the art: Current state of proteomic IVD landscape
and FDA's perspectives;
     Community initiatives: Overview of community (governmental
and non-governmental) initiatives to help standardize proteomic
technologies and provide quality control to discovery;
     Success stories: Description of FDA experience in the
clearance of IVDs that use proteomic technologies, with lessons learned
and challenges discovered in bringing proteomic-based assays to the
clinic; and
     Case study open discussion: In an open discussion, FDA
will present a hypothetical case study that includes assay design and
validation issues with which FDA has experience. The goal is to
stimulate discussion with attendees regarding what expectations from
FDA are reasonable, what validation by manufacturers is possible and
other challenges inherent in bringing these tests to the clinic and the
Agency. Possible points of discussion will be solicited from the
attendees, and may include:
    [cir] How can or should the FDA use community-developed reference
standards/assays to assess IVD validity?
    [cir] How can manufacturers assess accuracy in a multiplex/
multipeak assay without a reference standard for the analytes?
    [cir] Are there general rules for assay validation that cannot or
should not be applied to different platforms?
    [cir] How can or should late-stage validation considerations be
incorporated into early-stage assay development?

    Dated: May 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-10787 Filed 5-9-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: March 17, 2006 (Volume 71, Number 52)]
[Notices]
[Page 13824]
[DOCID:fr17mr06-52]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP99-176-114]

Natural Gas Pipeline Company of America; Notice of Negotiated
Rates

March 10, 2006.
    Take notice that on February 22, 2006, Natural Gas Pipeline Company
of America (Natural) tendered for filing as part of its FERC Gas
Tariff, Sixth Revised Volume No. 1, the following tariff sheets, to
become effective April 1, 2006:

Third Revised Sheet No. 26D
First Revised Sheet No. 26D.01
First Revised Sheet No. 26D.02
First Revised Sheet No. 414A

    Natural states that the purpose of this filing is to implement an
extension to an existing negotiated rate transaction. Also, Natural
states that it tenders for filing copies of the Firm Transportation and
Storage Negotiated Rate Agreement between Natural and Northern Illinois
Gas Company, d/b/a Nicor Gas.
    Natural states that copies of the filing are being mailed to all
parties set out on the Commission's official service list in Docket No.
RP99-176.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Sec.  154.210 of the Commission's regulations (18 CFR 154.210). Anyone
filing an intervention or protest must serve a copy of that document on
the Applicant. Anyone filing an intervention or protest on or before
the intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible online at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-3888 Filed 3-16-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 37 (Tuesday, February 25, 2020)]
[Notices]
[Pages 10727-10728]
[FR Doc No: 2020-03665]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2020-0003]

Advisory Committee on Construction Safety and Health (ACCSH):
Notice of ACCSH Workgroup Meetings

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Announcement of teleconference meetings of ACCSH workgroups.

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SUMMARY: ACCSH will hold teleconference meetings of the Education,
Training and Outreach workgroup and the Emerging and Current Issues
workgroup on March 5, 2020.

DATES: The Education, Training and Outreach workgroup will meet from
10:00 a.m. to 12:00 p.m., ET, and the Emerging and Current Issues
workgroup will meet from 1:00 p.m. to 3:00 p.m., ET, Thursday, March 5,
2020, by teleconference.

ADDRESSES:
    Submission of comments and requests to speak: Submit comments and
requests to speak at the ACCSH workgroup meetings by February 28, 2020,
identified by the docket number for this Federal Register notice
(Docket No. OSHA-2020-0003), using one of the following methods:
    Electronically: You may submit comments, including attachments,
electronically at: http://www.regulations.gov, the Federal eRulemaking
Portal. Follow the online instructions for submitting comments.
    Facsimile: If your comments, including attachments, do not exceed
10 pages, you may fax them to the OSHA Docket Office at<PHONE_NUMBER>.
    Regular mail, express mail, hand delivery, and messenger or courier
service: You may submit comments and attachments to the OSHA Docket
Office, Docket No. OSHA-2020-0003, Occupational Safety and Health
Administration, U.S. Department of Labor, Room N-3653, 200 Constitution
Avenue NW, Washington, DC 20210. Deliveries (express mail, hand
(courier) delivery, and messenger service) are accepted during the OSHA
Docket Office's normal business hours, Monday-Friday, 10:00 a.m. to
3:00 p.m., ET.
    Instructions: All submissions must include the agency name and the
OSHA docket number for this Federal Register notice (Docket No. OSHA-
2020-0003). Because of security-related procedures, submissions by
regular mail may result in a significant delay in receipt. Please
contact the OSHA Docket Office for information about security
procedures for making submissions by express mail, hand (courier)
delivery, and messenger service.
    Requests for special accommodations: Please submit requests for
special accommodations for this ACCSH meeting by February 28, 2020, to
Ms. Gretta Jameson, OSHA, Directorate of Construction, Room N-3476,
U.S. Department of Labor, telephone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT:
    For press inquiries: Mr. Frank Meilinger, Director, OSHA Office of
Communications, U.S. Department of Labor; telephone<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    For general information about ACCSH: Mr. Damon Bonneau, OSHA,
Directorate of Construction, U.S. Department of Labor; telephone (202)
693-2183; email<EMAIL_ADDRESS>    For copies of this Federal Register Notice: Electronic copies of
this Federal Register notice are available at: http://www.regulations.gov. This notice, as well as news releases and other
relevant information, are also available at OSHA's web page at:
www.osha.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    ACCSH advises the Secretary of Labor and the Assistant Secretary of
Labor for Occupational Safety and Health (Assistant Secretary) in the
formulation of standards affecting the construction industry, and on
policy matters arising in the administration of the safety and health
provisions under the Contract Work Hours and Safety Standards Act
(Construction Safety Act (CSA)) (40 U.S.C. 3701 et seq.) and the
Occupational Safety and Health Act of 1970 (OSH Act) (29 U.S.C. 651 et
seq.) (see also 29 CFR 1911.10 and 1912.3). In addition, the OSH Act
and CSA require the Assistant Secretary to consult with ACCSH before
the agency proposes any occupational safety and health standard
affecting construction activities (29 CFR 1911.10; 40 U.S.C. 3704).
    ACCSH operates in accordance with the CSA, the OSH Act, the Federal
Advisory Committee Act (FACA) (5 U.S.C. App. 2), and regulations issued
pursuant to those statutes (29 CFR part 1912, 41 CFR part 102-3). ACCSH
generally meets two times a year.

II. Meeting Information

    Attending the meeting: Attendance at this ACCSH meeting will be by
teleconference only. The dial-in number and passcode for the meeting
are as follows: Dial-in number: 1-888-658-5408; Passcode: 7001480. For
additional information about the telecommunication requirements for the
meeting, please contact Ms. Veneta Chatmon, OSHA, Directorate of
Construction, Room N-3468, U.S. Department of Labor, telephone (202)
693-2020; email<EMAIL_ADDRESS>    Meeting agenda: The tentative agendas for the workgroup meetings
include:

     Education, Training and Outreach workgroup:
    1. Trench Safety.
    2. Fall Prevention.
     Emerging and Current Issues workgroup:
    1. Opioids.
    2. Suicides in construction.
    Requests to speak at ACCSH meeting: Attendees who want to address
the workgroups must submit a request to speak, as well as any written
or electronic presentation, by February 28, 2020, using one of the
methods listed in the ADDRESSES section. The request must state:
     The amount of time requested to speak;
     The interest you represent (e.g., business, organization,
affiliation), if any; and
     A brief outline of your presentation.
    OSHA will place comments and requests to speak, including personal
information, in the public docket, which will be available online.
Therefore, OSHA cautions interested parties about submitting personal
information such as Social Security Numbers and birthdates.
    Docket: To read or download documents in the public docket for this
ACCSH meeting, go to http://www.regulations.gov. All documents in the
public docket are listed in the index; however, some documents (e.g.,
copyrighted material) are not publicly available to read or download
through http://www.regulations.gov. All submissions are available for
inspection and, when permitted, copying at the OSHA Docket Office at
the above address. For information on using http://www.regulations.gov
to make submissions or to access the docket, click on the ``Help'' tab
at the top of the homepage. Contact the OSHA Docket Office for
information about materials not available through that website and for
assistance in using the internet to locate submissions and other
documents in the docket.

Authority and Signature

    Loren Sweatt, Principal Deputy Assistant Secretary of Labor for
Occupational Safety and Health, authorized the preparation of this
notice under the authority granted by 29 U.S.C. 655(b)(1) and 656(b), 5
U.S.C. App. 2, Secretary of Labor's Order No. 1-2012 (77 FR 3912), and
29 CFR part 1912.

    Signed at Washington, DC, on February 13, 2020.
Loren Sweatt,
Principal Deputy Assistant Secretary of Labor for Occupational Safety
and Health.
[FR Doc. 2020-03665 Filed 2-24-20; 8:45 am]
 BILLING CODE 4510-26-P


[Federal Register Volume 86, Number 160 (Monday, August 23, 2021)]
[Rules and Regulations]
[Pages 46966-46968]
[FR Doc No: 2021-18063]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2020-0647]
RIN 1625-AA09

Drawbridge Operation Regulation; New Jersey Intracoastal
Waterway, Point Pleasant, NJ

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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SUMMARY: The Coast Guard is changing the regulation that governs the
Route 88 (Veterans Memorial) Bridge and Route 13 (Lovelandtown) Bridge
across the NJICW at Point Pleasant Canal, mile 3.0 and 3.9,
respectively at Point Pleasant, NJ. The final rule allows the
drawbridges to be maintained in the closed position overnight.

DATES: The rule is effective September 22, 2021.

ADDRESSES:  To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2020-0647. In the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call or email Mr. Mickey Sanders, Bridge Administration Branch,
Fifth District, U.S. Coast Guard, telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
OMB Office of Management and Budget
NPRM Notice of Proposed Rulemaking (Advance, Supplemental)
Sec.  Section
U.S.C. United States Code
NJICW New Jersey Intracoastal Waterway

II. Background, Purpose and Legal Basis

    On March 26, 2021, we published a noticed of proposed rulemaking
(NPRM) entitled Drawbridge Operation Regulation; New Jersey
Intracoastal Waterway, Point Pleasant, NJ in the Federal Register (86
FR 16153). We received no comments on this rule. The Route 88 (Veterans
Memorial) Bridge across the NJICW at Point Pleasant Canal, mile 3.0, at
Point Pleasant, NJ, has a vertical clearance of 10 feet above mean high
water in the closed-to-navigation position. The bridge currently
operates under 33 CFR 117.5.
    The Route 13 (Lovelandtown) Bridge across the NJICW at Point
Pleasant Canal, mile 3.9, at Point Pleasant, NJ, has a vertical
clearance of 30 feet above mean high water in the closed-to-navigation
position. The bridge currently operates under 33 CFR 117.5.
    The Point Pleasant Canal is used predominately by recreational
vessels and pleasure craft. The three-year average number of bridge
openings, maximum number of bridge openings, and bridge openings
between 11 p.m. to 7 a.m., by month and overall for August 2017,
through August 2020, as drawn from the data contained in the bridge
tender logs, is presented below. There is a monthly average of two
bridge openings for each bridge, from 11 p.m. to 7 a.m., from August
2017 to August 2020.

------------------------------------------------------------------------
                                                             Average
            Month               Average      Maximum      openings  11
                                openings     openings      p.m.-7 a.m.
------------------------------------------------------------------------
January.....................            4           14                 0
February....................            2            7                 0
March.......................            7           21                 0
April.......................           24           72                 2
May.........................           51          154                 6
June........................           74          223                18
July........................          125          376                20
August......................          101          407                20
September...................           63          190                 8
October.....................           51          155                 6
November....................           29           89                 7
December....................           16           49                 1
------------------------------------------------------------------------

III. Discussion of Final Rule

    The bridge owner requested to modify the operating regulation for
the bridges, due to the limited number of requested openings of the
bridges from 11 p.m. to 7 a.m., over a period of approximately three
years. The data presented in the table above demonstrates that the
requested modification may be implemented with de minimis impact to
navigation. The modification will allow the drawbridges to be
maintained in the closed position from 11:01 p.m. to 6:59 a.m. and
shall open on signal, if at least four hours advance notice is given.

IV. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive Orders related to rulemaking. Below we summarize our analyses
based on these statutes and Executive Orders and we discuss First
Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13563 emphasizes the importance of
quantifying both costs and benefits, of reducing costs, of harmonizing
rules, and of promoting flexibility. This rule has not been designated
a ``significant regulatory action,'' under Executive Order 12866.
Accordingly, it has not been reviewed by the Office of Management and
Budget. This regulatory action determination is based on the fact that
an average of only two bridge openings occurred per month from 11 p.m.
to 7 a.m., from August 2017 through August 2020.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard received no comments from the Small Business
Administration on this rule. The Coast Guard certifies under 5 U.S.C.
605(b) that this rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit the
bridges may be small entities, for the reasons stated in section IV.A
above this proposed rule would not have a significant economic impact
on any vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section. The Coast Guard will not retaliate against small entities that
question or complain about this rule or any policy or action of the
Coast Guard.

C. Collection of Information

    This rule would call for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
(Federalism), if it has 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. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, (Consultation and Coordination with Indian Tribal
Governments), because it would 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.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01, Rev.1, associated implementing
instructions, and Environmental Planning Policy COMDTINST 5090.1
(series), which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f). The
Coast Guard has determined that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This rule promulgates the operating
regulations or procedures for drawbridges. Normally such actions are
categorically excluded from further review, under paragraph L49, of
Chapter 3, Table 3-1 of the U.S. Coast Guard Environmental Planning
Implementation Procedures.
    Neither a Record of Environmental Consideration nor a Memorandum
for the Record are required for this rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 117

    Bridges.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
1. The authority citation for part 117 continues to read as follows:

    Authority:  33 U.S.C. 499; 33 CFR 1.05-1; DHS Delegation No.
0170.1.

0
2. Revise Sec.  117.733 as follows:
0
a. Remove paragraphs (i) and (k);
0
b. Redesignate paragraph (j) as paragraph (k);
0
c. Redesignate paragraphs (b) through (h) as (d) through (i), and;
0
d. Add new paragraphs (b) and (c).
    The additions read as follows:

Sec.  117.733   New Jersey Intracoastal Waterway.

* * * * *
    (b) The draw of the Route 88 Bridge, mile 3.0, across Point
Pleasant Canal at Point Pleasant, shall operate as follows:
    (1) From 7 a.m. to 11 p.m. the draw shall open on signal.

    (2) From 11:01 p.m. to 6:59 a.m. the draw shall open on signal, if
at least four hours advance notice is given.
    (c) The draw of the Route 13 Bridge, mile 3.9, across Point
Pleasant Canal at Point Pleasant, shall operate as follows:
    (1) From 7 a.m. to 11 p.m. the draw shall open on signal.
    (2) From 11:01 p.m. to 6:59 a.m. the draw shall open on signal, if
at least four hours advance notice is given.
* * * * *

    Dated: August 9, 2021.
L.M. Dickey,
Rear Admiral, U.S. Coast Guard, Commander, Fifth Coast Guard District.
[FR Doc. 2021-18063 Filed 8-20-21; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 88, Number 36 (Thursday, February 23, 2023)]
[Notices]
[Pages 11505-11506]
[FR Doc No: 2023-03688]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2022-0199]

Hours of Service of Drivers: Application for Exemption; Wayne
Moore, Jr.

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition; denial of application for
exemption.

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SUMMARY: FMCSA announces its decision to deny the application from
Wayne Moore, Jr. for an exemption from four provisions of the Federal
hours-of-service (HOS) regulations. FMCSA analyzed the application and
public comments and determined that the exemption would not achieve a
level of safety that is equivalent to, or greater than, the level that
would be achieved absent such exemption.

FOR FURTHER INFORMATION CONTACT: Mr. Richard Clemente, FMCSA Driver and
Carrier Operations Division; Office of Carrier, Driver and Vehicle
Safety Standards;<PHONE_NUMBER> or [email protected]. If you have
questions on viewing or submitting material to the docket, contact
Docket Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

Viewing Comments and Documents

    To view comments, go to www.regulations.gov, insert the docket
number ``FMCSA-2022-0199'' in the keyword box, and click ``Search.''
Next, sort the results by ``Posted (Newer-Older),'' choose the first
notice listed, and click ``View Related Comments.''
    To view documents mentioned in this notice as being available in
the docket, go to www.regulations.gov, insert the docket number
``FMCSA-2022-0199'' in the keyword box, click ``Search,'' and chose the
document to review.
    If you do not have access to the internet, you may view the docket
by visiting Dockets Operations in Room W12-140 on the ground floor of
the DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590,
between 9 a.m. and 5 p.m., ET, Monday through Friday, except Federal
holidays. To be sure someone is there to help you, please call (202)
366-9317 or<PHONE_NUMBER> before visiting Dockets Operations.

II. Legal Basis

    FMCSA has authority under 49 U.S.C. 31136(e) and 31315(b) to grant
exemptions from certain Federal Motor Carrier Safety Regulations
(FMCSRs). FMCSA must publish a notice of each exemption request in the
Federal Register (49 CFR 381.315(a)). The Agency must provide the
public an opportunity to inspect the information relevant to the
application, including any safety analyses that have been conducted.
The Agency must also provide an opportunity for public comment on the
request.
    The Agency reviews safety analyses and public comments submitted
and determines whether granting the exemption would likely achieve a
level of safety equivalent to, or greater than, the level that would be
achieved by the current regulation (49 CFR 381.305). The decision of
the Agency must be published in the Federal Register (49 CFR
381.315(b)) with the reasons for denying or granting the application
and, if granted, the name of the person or class of persons receiving
the exemption, and the regulatory provision from which the exemption is
granted. The notice must also specify the effective period (up to 5
years) and explain the terms and conditions of the exemption. The
exemption may be renewed (49 CFR 381.300(b)).

III. Background

Current Regulatory Requirements

    To reduce the possibility of driver fatigue, FMCSA's HOS
regulations in 49 CFR part 395 limit the time drivers of commercial
motor vehicles (CMVs) may drive. The HOS regulations in 49 CFR
395.3(a)(1) prohibit driving after 11 hours driving or 14 consecutive
hours on duty until the driver has been off duty for a minimum of 10
consecutive hours, or the equivalent of at least 10 consecutive hours.
Under 49 CFR 395.3(a)(2), commonly referred to as the 14-hour ``driving
window,'' a driver has 14 consecutive hours in which to drive up to 11
hours after being off duty for 10 or more consecutive hours. Section
395.3(a)(3)(ii) requires drivers to take a 30-minute break when they
have driven

for a period of 8 cumulative hours without at least a 30-minute
interruption. The break may be satisfied by 30 consecutive minutes of
on-duty not driving, off duty, or sleeper berth time, or any
combination of these taken consecutively. Section 395.3(b)(2) prohibits
drivers for a motor carrier that operates CMVs every day of the week
from driving a CMV after being on duty for 70 hours in any 8
consecutive days.

Applicant's Request

    Mr. Moore requests a five-year exemption from 49 CFR 395.3(a)(1)
and (2), 395.3(a)(3)(ii), and 395.3(b)(2). Mr. Moore is a CMV operator
who has driven for over 25 years, and currently works for a large
transportation company in Indiana. He states that he would like the
ability to split off-duty time into periods that are more conducive to
proper rest and sleep without having to comply with the HOS
regulations. He also states that he has the ability to decide whether
he is sufficiently rested to drive.

IV. Method To Ensure an Equivalent or Greater Level of Safety

    The applicant believes that his level of safety under the
exemption, if granted, would be better than he could achieve by
complying with the HOS regulations because he would be able to get the
proper rest when needed. He states that he can safely drive and knows
when he is tired and has an excellent driving record, with no accidents
or incidents and has never had any HOS violations.

V. Public Comments

    On December 1, 2022, FMCSA published Mr. Moore's application and
requested public comment (87 FR 73804). The Agency received 79 total
comments, the majority from individual drivers and owner-operators.
Thirty supported the request, 30 opposed it, and 18 commenters offered
no position either for or against the request. The Truck Safety
Coalition, Citizens for Reliable and Safe Highways, and Parents Against
Tired Truckers made the following joint comment: ``[we] request this
inadequately justified exemption to HOS requirements be denied in full.
Large truck crash fatalities continue to increase at an alarming pace,
and it is incumbent on the Department of Transportation and FMCSA to
take every measure possible to reverse this trend and affirm life
safety as its top priority by denying the request.'' General themes
from other opposing comments included: (1) HOS rules do save lives and
are there for everyone's safety; (2) the Agency cannot grant this
request for individuals; and (3) there is no scientific data to support
the HOS claims.
    Commenters supporting the exemption suggested a graduated program
that allowed more driving hours for drivers with more driving
experience. One commenter said: ``I feel that the FMCSA should take a
3-step approach to the hours-of-service requirements and implement
rules for 5-10-15 year drivers who have demonstrated a level of safety
equal to or greater than what was achieved with the hours of service.''
None of the commenters who supported the exemption request presented
relevant data or reasoning to demonstrate how an equivalent level of
safety would be met if the exemption were granted. Those taking no
position either for or against Mr. Moore's application provided general
comments and complaints about the HOS and the Electronic Logging Device
regulations and suggested that the Agency needs to revise them.

VI. FMCSA Safety Analysis and Decision

    After evaluating Mr. Moore's application and the public comments,
FMCSA denies the exemption request. Under 49 U.S.C. 31315(b)(1), to
grant an exemption, FMCSA must ``find that the exemption would likely
achieve a level of safety that is equivalent to, or greater than, the
level that would be achieved absent such exemption.'' Among other
requirements, 49 CFR 381.310(c)(5) requires a person seeking an
exemption to explain how it would ensure that it could achieve an
equivalent level of safety. Mr. Moore failed to explain how he would
maintain a level of safety equivalent to, or greater than, the level
achieved without the exemption. Although Mr. Moore stated that he would
be responsible for ensuring that he has adequate rest and that he has
an excellent driving record and no HOS violations, those
representations do not provide a basis from which the Agency could
conclude that the proposed exemption would provide an equivalent level
of safety.
    The Agency's HOS regulations are designed to prevent fatigued
drivers from operating by imposing limits on when and how long an
individual may drive, to ensure that drivers stay awake and alert, and
to reduce the possibility of cumulative fatigue (85 FR 33396, Sept. 29,
2020). A fatigued driver is more prone to perform poorly on tasks
requiring the vigilance and decision-making needed to operate a CMV
safely than a person who is alert. The Agency also agrees with
commenters who argued that exempting one individual from the HOS
regulations could open the door for a huge number of similar exemption
requests. Such a result would be inconsistent with a primary goal of
the HOS regulations.

    For the reasons stated, FMCSA denies Wayne Moore, Jr.'s
exemption application.
Robin Hutcheson,
Administrator.
[FR Doc. 2023-03688 Filed 2-22-23; 8:45 am]
BILLING CODE 4910-EX-P