               UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                                ANN ARBOR, MI 48105

September 23, 2010
                                                         OFFICE OF
                                                      AIR AND RADIATION

MEMORANDUM

SUBJECT:	BASELINE FLEET FILE IN SUPPORT OF THE NOTICE OF INTENT

FROM:	A. Neam, Assessment and Standards Division

--------------------------------------------------------------------------------
TO:		EPA/NHTSA Joint Rulemaking to Establish Light-duty Vehicle GHG Emissions Standards and CAFE Standards for Model Year 2017 and Later; Docket Number EPA-HQ-OAR-2010-0799

This memo was created to document the submission of the baseline fleet file into the docket.  The file name to the baseline fleet file is "2010_09_23 2008_2020 AND 2025 Prod Sum Median Fuel Price For Docket.xls".


[Federal Register Volume 84, Number 39 (Wednesday, February 27, 2019)]
[Rules and Regulations]
[Pages 6315-6317]
[FR Doc No: 2019-03268]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0554; Product Identifier 2018-NM-064-AD; Amendment
39-19569; AD 2019-03-17]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

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

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Airbus SAS Model A318 series airplanes; Model A319 series airplanes;
Model A320 series airplanes; and Model A321 series airplanes. This AD
was prompted by a revision of an airworthiness limitation item (ALI)
document, which requires more restrictive maintenance requirements and
airworthiness limitations. This AD requires revising the operator's
maintenance or inspection program, as applicable, to incorporate new
maintenance requirements and airworthiness limitations. We are issuing
this AD to address the unsafe condition on these products.

DATES: This AD is effective April 3, 2019.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of April 3,
2019.

ADDRESSES: For service information identified in this final rule,
contact Airbus SAS, Airworthiness Office--EIAS, Rond-Point Emile
Dewoitine No: 2, 31700 Blagnac Cedex, France; telephone +33 5 61 93 36
96; fax +33 5 61 93 44 51; email<EMAIL_ADDRESS>
internet http://www.airbus.com. You may view this service information
at the FAA, Transport Standards Branch, 2200 South 216th St., Des
Moines, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0554.

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-
0554; 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 final rule, the regulatory evaluation, any comments received, and
other information. The address for Docket Operations (phone: 800-647-
5527) is U.S. Department of Transportation, Docket Operations, M-30,
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
International Section, Transport Standards Branch, FAA, 2200 South
216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain Airbus SAS Model
A318 series airplanes; Model A319 series airplanes; Model A320 series
airplanes; and Model A321-111, -112, -131, -211, -212, -213, -231, -
232, -251N, -253N, and -271N airplanes. The NPRM published in the
Federal Register on July 17, 2018 (83 FR 33159). The NPRM was prompted
by a revision of an ALI document, which requires more restrictive
maintenance requirements and airworthiness limitations. The NPRM
proposed to require revising the operator's maintenance or inspection
program, as applicable, to incorporate new maintenance requirements and
airworthiness limitations.
    We issued a supplemental NPRM (SNPRM) to amend 14 CFR part 39 by
adding an AD that would apply to certain Airbus SAS Model A318 series
airplanes; Model A319 series airplanes; Model A320 series airplanes;
and Model A321 series airplanes. The SNPRM published in the Federal
Register on November 8, 2018 (83 FR 55830). We issued the SNPRM to
include revised restrictive requirements and add airplanes to the
applicability.
    We are issuing this AD to address a safety-significant latent
failure (that is not annunciated), which, in combination with one or
more other specific failures or events, could result in a hazardous or
catastrophic failure condition.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA AD
2018-0180, dated August 27, 2018 (referred to after this as the
Mandatory Continuing Airworthiness Information, or ``the MCAI''), to
correct an unsafe condition for certain Airbus SAS Model A318 series
airplanes; Model A319 series airplanes; Model A320 series airplanes;
and Model A321 series airplanes. The MCAI states:

    The airworthiness limitations for the Airbus A320 family
aeroplanes, which are approved by EASA, are currently defined and
published in the A318/A319/A320/A321 ALS [Airworthiness Limitations
Section] document(s). The airworthiness limitations applicable to
the Certification Maintenance Requirements (CMR), which are approved
by EASA, are published in ALS Part 3.
    Failure to accomplish these instructions could result in an
unsafe condition.
    Previously, EASA issued AD 2017-0168 to require accomplishment
of all maintenance tasks as described in ALS Part 3 at Revision 05.

    Since that [EASA] AD was issued, Airbus published the ALS,
including new and/or more restrictive requirements, and new A321
models were certified and added to the Applicability of the ALS.
    For the reason described above, this [EASA] AD retains the
requirements of EASA AD 2017-0168, which is superseded, expands the
Applicability and requires accomplishment of the actions specified
in the ALS.

    You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0554.

Comments

    We gave the public the opportunity to participate in developing
this final rule. We have considered the comment received. United
Airlines indicated its support for the SNPRM.

Conclusion

    We reviewed the relevant data, considered the comment received, and
determined that air safety and the public interest require adopting
this final rule as proposed, except for minor editorial changes. We
have determined that these minor changes:
     Are consistent with the intent that was proposed in the
SNPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the SNPRM.

Related Service Information Under 1 CFR Part 51

    Airbus has issued Airbus A318/A319/A320/A321 Airworthiness
Limitations Section (ALS) Part 3, Certification Maintenance
Requirements (CMR), Revision 06, dated June 13, 2018. The service
information describes maintenance instructions and airworthiness
limitations, including updated inspections and intervals, to be
incorporated into the operator's maintenance or inspection program.
This service information is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 1,250 airplanes of U.S. registry.
We estimate the following costs to comply with this AD:
    We have determined that revising the operator's maintenance or
inspection program takes an average of 90 work-hours per operator,
although we recognize that this number may vary from operator to
operator. In the past, we have estimated that this action takes 1 work-
hour per airplane. Since operators incorporate maintenance or
inspection program changes for their affected fleet(s), we have
determined that a per-operator estimate is more accurate than a per-
airplane estimate. Therefore, we estimate the total cost per operator
to be $7,650 (90 work-hours x $85 per work-hour)

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 transport category airplanes and
associated appliances to the Director of the System Oversight Division.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under 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.

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2019-03-17 Airbus SAS: Amendment 39-19569; Docket No. FAA-2018-0554;
Product Identifier 2018-NM-064-AD.

(a) Effective Date

    This AD is effective April 3, 2019.

(b) Affected ADs

    This AD affects AD 2017-25-04, Amendment 39-19118 (82 FR 58098,
December 11, 2017) (``AD 2017-25-04'').

(c) Applicability

    This AD applies to the Airbus SAS airplanes identified in
paragraphs (c)(1), (c)(2), (c)(3), and (c)(4) of this AD,
certificated in any category, with an original certificate of
airworthiness or original export certificate of airworthiness issued
on or before June 13, 2018.
    (1) Model A318-111, -112, -121, and -122 airplanes.
    (2) Model A319-111, -112, -113, -114, -115, -131, -132, and -133
airplanes.
    (3) Model A320-211, -212, -214, -216, -231, -232, -233, -251N,
and -271N airplanes.
    (4) Model A321-111, -112, -131, -211, -212, -213, -231, -232, -
251N, -251NX, -252N, -252NX, -253N, -253NX, -271N, -271NX, -272N,
and -272NX airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 05, Time Limits/
Maintenance Checks.

(e) Reason

    This AD was prompted by a revision of an airworthiness
limitation item (ALI) document, which requires more restrictive
maintenance requirements and airworthiness limitations. We are
issuing this AD to address a safety-significant latent failure (that
is not annunciated), which, in combination with one or more other
specific failures or events,

could result in a hazardous or catastrophic failure condition.

(f) Compliance

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

(g) Revision of Maintenance or Inspection Program

    Within 90 days after the effective date of this AD, revise the
operator's maintenance or inspection program, as applicable, to
incorporate the information specified in Airbus A318/A319/A320/A321
Airworthiness Limitations Section (ALS) Part 3, Certification
Maintenance Requirements (CMR), Revision 06, dated June 13, 2018
(``ALS Part 3, CMR, R6''). The initial compliance time for
accomplishing the tasks specified in ALS Part 3, CMR, R6, is at the
applicable time specified in ALS Part 3, CMR, R6, or within 90 days
after the effective date of this AD, whichever occurs later.

(h) Terminating Actions for AD 2017-25-04

    Accomplishing the actions required by paragraph (g) of this AD
terminates all of the requirements of AD 2017-25-04.

(i) No Alternative Actions or Intervals

    After the operator's maintenance or inspection program, as
applicable, has been revised as required by paragraph (g) of this
AD, no alternative actions (e.g., inspections) or intervals may be
used unless the actions and intervals are approved as an alternative
method of compliance (AMOC) in accordance with the procedures
specified in paragraph (j)(1) of this AD.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards 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 International Section, send it to the attention of
the person identified in paragraph (k)(2) of this AD. Information
may be emailed to<EMAIL_ADDRESS>    (i) 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.
    (ii) AMOCs approved previously for AD 2017-25-04, or AD 2014-22-
08, Amendment 39-18013 (79 FR 67042, November 12, 2014), that allow
incorporation of ALS Part 3, CMR, R6, are considered approved as
AMOCs for the corresponding provisions of this AD.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Section, Transport Standards Branch, FAA; or the European Aviation
Safety Agency (EASA); or Airbus SAS's EASA Design Organization
Approval (DOA). If approved by the DOA, the approval must include
the DOA-authorized signature.
    (3) Required for Compliance (RC): If any service information
contains procedures or tests that are identified as RC, those
procedures and tests must be done to comply with this AD; any
procedures or tests that are not identified as RC are recommended.
Those procedures and tests that are not identified as RC may be
deviated from using accepted methods in accordance with the
operator's maintenance or inspection program without obtaining
approval of an AMOC, provided the procedures and tests identified as
RC can be done and the airplane can be put back in an airworthy
condition. Any substitutions or changes to procedures or tests
identified as RC require approval of an AMOC.

(k) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA AD 2018-0180, dated August 27, 2018, for related
information. This MCAI may be found in the AD docket on the internet
at http://www.regulations.gov by searching for and locating Docket
No. FAA-2018-0554.
    (2) For more information about this AD, contact Sanjay Ralhan,
Aerospace Engineer, International Section, Transport Standards
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>.

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Airbus A318/A319/A320/A321 Airworthiness Limitations Section
(ALS) Part 3, Certification Maintenance Requirements (CMR), Revision
06, dated June 13, 2018.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact
Airbus SAS, Airworthiness Office--EIAS, Rond-Point Emile Dewoitine
No: 2, 31700 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax
+33 5 61 93 44 51; email<EMAIL_ADDRESS>internet
http://www.airbus.com.
    (4) You may view this service information at the FAA, Transport
Standards Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Des Moines, Washington, on February 14, 2019.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2019-03268 Filed 2-26-19; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 162 (Monday, August 22, 2016)]
[Notices]
[Pages 56745-56750]
[FR Doc No: 2016-19948]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2016-0069]

Commercial Driver's Licenses; Proposed Pilot Program To Allow
Persons Between the Ages of 18 and 21 With Military Driving Experience
To Operate Commercial Motor Vehicles in Interstate Commerce

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

ACTION: Notice of proposed pilot program; request for comments.

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SUMMARY: As required by section 5404 of the Fixing America's Surface
Transportation (FAST) Act, FMCSA proposes a pilot program to allow a
limited number of individuals between the ages of 18 and 21 to operate
commercial motor vehicles (CMVs) in interstate commerce if they have
received specified heavy-vehicle driver training while in military
service and are sponsored by a participating motor carrier. During the
3-year pilot program, the safety records of these younger drivers (the
study group) would be compared to the records of a control group of
comparable size, comprised of drivers who are 21 years of age or older
and who have comparable training and experience in driving vehicles
requiring a commercial driver's license (CDL). The control group would
consist of volunteer drivers who meet specified criteria and are
employed by a participating carrier. The comparison of the two groups'
performance would help to determine whether age is a critical safety
factor. FMCSA also proposes criteria for a working group to consult
with the Agency in conducting, monitoring, and evaluating the pilot
program. Further, the Agency outlines procedural steps and a data
collection plan, and requests comments on these elements.

DATES: Comments must be received on or before September 21, 2016.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket ID FMCSA-2016-0069 using any of the
following methods:
     Federal eRulemaking Portal: www.regulations.gov. Follow
the online instructions for submitting comments.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building, Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building, Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: 1-202-493-2251
    Each submission must include the Agency name and the docket number
for this notice. Note that DOT posts all comments received without
change to www.regulations.gov, including any personal information
included in a comment. Please see the Privacy Act heading below.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: Mr. Selden Fritschner, CDL Division,
Federal Motor Carrier Safety Administration, 1200 New Jersey Avenue
SE., Washington, DC 20590-0001, by email at<EMAIL_ADDRESS>
or by telephone at<PHONE_NUMBER>. If you have questions on viewing or
submitting material to the docket, contact Docket Services, telephone
(202) 366-9826.

SUPPLEMENTARY INFORMATION:

I. Public Participation and Request for Comments

    FMCSA encourages you to participate by submitting comments and
related materials. In this notice, FMCSA requests certain information,
but comments are not limited to responses to those requests.

Submitting Comments

    If you submit a comment, please include the docket number for this
notice (FMCSA-2016-0069), indicate the specific section of this
document to which the comment applies, and provide a reason for
suggestions or recommendations. You may submit your comments and
material online, by fax, mail, or hand delivery, but please use only
one of these means. FMCSA recommends that you include your name and a
mailing address, an email address, or a phone number in the body of
your document so the Agency can contact you if it has questions
regarding your submission.
    To submit your comment online, go to www.regulations.gov, put the
docket number, ``FMCSA-2016-0069'' in the ``Keyword'' box, and click
``Search.'' When the new screen appears, click on the ``Comment Now!''
button and type your comment into the text box in the following screen.
Choose whether you are submitting your comment as an individual or on
behalf of a third party and then submit. If you submit your comments by
mail or hand delivery, submit them in an unbound format, no larger than
8\1/2\ by 11 inches, suitable for copying and electronic filing. If you
submit comments by mail and would like to know that they reached the
facility, please enclose a stamped, self-addressed postcard or
envelope. FMCSA will consider all comments and material received during
the comment period.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this notice as
being available in the docket, go to www.regulations.gov and insert the
docket number, ``FMCSA-2016-0069'' in the ``Keyword'' box and click
``Search.'' Next, click the ``Open Docket Folder'' button and choose
the document listed to review. If you do not have access to the
Internet, you may view the docket online by visiting the Docket
Management Facility 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., e.t., Monday through Friday, except Federal holidays.

II. Legal Basis

    On June 9, 1998, the President signed the Transportation Equity Act
for the 21st Century (TEA-21) (Pub. L. 105-178, 112 Stat. 107). Section
4007 of TEA-21 amended 49 U.S.C. 31315 and 31136(e) to give the
Secretary of Transportation (the Secretary) authority to grant waivers
and exemptions from the Federal Motor Carrier Safety Regulations
(FMCSRs) and to conduct pilot programs. A waiver is limited to a period
of 3 months and may be granted without requesting public comment. By
contrast, an exemption may remain in effect for up to 5 years \1\ and
may be renewed. The Secretary must provide the public with an
opportunity to

comment on each exemption request prior to granting or denying it.
---------------------------------------------------------------------------

    \1\ Section 5206 of the Fixing America's Surface Transportation
(FAST) Act amended 49 U.S.C. 31315(b)(2) to extend the maximum
duration of an exemption from 2 years to 5 years, effective October
1, 2015.
---------------------------------------------------------------------------

    Section 4007 also authorizes pilot programs in which one or more
exemptions are granted to allow for the testing of innovative
alternatives to certain FMCSRs. FMCSA must publish in the Federal
Register a detailed description of each pilot program, including the
exemptions being considered, and provide notice and an opportunity for
public comment before the effective date of the program. The Agency is
required to ensure that the safety measures in the pilot programs are
designed to achieve a level of safety that is equivalent to, or greater
than, the level of safety that would be achieved through compliance
with the safety regulations. The maximum duration of pilot programs is
3 years from the starting date.
    At the conclusion of each pilot program, FMCSA must report to
Congress its findings, conclusions, and recommendations, including
suggested amendments to laws and regulations that would enhance motor
carrier, CMV, and driver safety, and improve compliance with the
FMCSRs.
    Section 4007 was implemented through an interim final rule (IFR) on
December 8, 1998 (63 FR 67600) and codified at 49 CFR part 381. The IFR
was finalized on August 20, 2004 (69 FR 51589). The final rule
established procedures applicants must follow to request waivers and
apply for exemptions from the FMCSRs and procedures to propose and
manage pilot programs.
    Section 5404 of the FAST Act (Pub. L. 114-94, 129 Stat. 1312, 1549,
Dec. 4, 2015) requires the Secretary of Transportation to conduct a
commercial driver pilot program to ``. . . study the feasibility,
benefits, and safety impacts of allowing a covered driver to operate a
commercial motor vehicle in interstate commerce.'' A ``covered driver''
is defined as a member or former member of the armed forces or reserve
and national guard components between the ages of 18 and 21, who is
qualified in a Military Occupational Specialty to operate a CMV or
similar vehicle. A driver participating in the program may not
transport passengers or hazardous cargo, or operate a vehicle in a
``special configuration.''
    Section 5404 requires the pilot program to collect and analyze data
regarding crashes involving covered drivers participating in the
program, and drivers under the age of 21 operating CMVs in intrastate
commerce. (See Section VIII of this notice.)
    Section 5404 also requires the Secretary to ``. . . conduct,
monitor, and evaluate . . .'' the pilot program in consultation with a
working group consisting of representatives of the armed forces,
industry, drivers, safety advocacy organizations, and State licensing
and enforcement officials. The working group must review the data
collected and make recommendations to the Secretary regarding the
feasibility, benefits, and safety impacts of allowing a covered driver
to operate in interstate commerce. (See Section V of this notice.)
III. Background

Applicable Regulations

    Drivers of CMVs engaged in interstate commerce must be at least 21
years of age (49 CFR 391.11(b)(1)). This includes CMVs for which CDLs
are required, as well as certain other CMVs for which a CDL is not
required.
    In the May 9, 2011, final rule on ``Commercial Driver's License
Testing and Commercial Learner's Permit Standards'' (76 FR 26854), the
Agency set a minimum age of 18 for an individual to obtain a commercial
learner's permit (CLP) prior to obtaining a CDL. An 18-year-old CLP
holder is allowed to drive in intrastate commerce only. Therefore, the
proposed pilot program requires that participating drivers be provided
relief from sections of 49 CFR parts 383 and 391 concerning minimum age
requirements.

Prior Younger Driver Pilot Program Efforts

    In the early 1970s, the Federal Highway Administration (FHWA),
FMCSA's predecessor agency, examined the subject of the minimum age of
CMV drivers as part of a comprehensive overhaul of the driver
qualification requirements. FHWA conducted a literature review and
analyzed crash statistics and psychological data. The result was a 1975
report titled ``Minimum Age Requirements of the Federal Motor Carrier
Safety Regulations.'' A copy of the report is filed in the docket
identified at the beginning of this notice. The Agency found that most
drivers under the age of 21 ``lack the general maturity, skill and
judgment that is necessary in handling commercial motor vehicles.'' The
report concluded that there was no support for lowering the age limit
of 21.
    Subsequently, on October 2, 2000, the Truckload Carriers
Association (TCA) petitioned FMCSA to conduct a younger driver pilot
program. Motor carriers, truck driver training schools, a trade
association, and an insurance company joined in the petition asking
FMCSA to authorize a pilot program to determine if CMV drivers under
age 21 could operate CMVs safely in interstate commerce. Petitioners
stated that this pilot would address the shortage of CMV drivers in the
trucking industry. Petitioners also asserted that recruiting young
persons as truck drivers would be easier if they could be approached
immediately after graduation from high school.
    The pilot program proposed by TCA would have involved a minimum of
48 weeks of intensive classroom and driving instruction and supervision
that was designed to lead to full-time employment as an interstate CMV
driver. Each younger driver (18 to 21 years of age) would attend a
truck driver training school approved by the Professional Truck Driver
Institute for a minimum of 22 weeks and receive 8 weeks of training in
a motor carrier's ``driver finishing'' program. This would be followed
by 18 weeks of team driving with an older, more experienced driver.
Younger drivers would be required to pass the performance standards of
the entire 48-week program and reach the age of 19 to begin solo
driving.
    On February 20, 2001, FMCSA published a notice asking six questions
about the proposed pilot program and requesting public comment on the
TCA petition (66 FR 10935). FMCSA received more than 1,600 comments.
Very few commenters presented data either for or against the program.
More than 90 percent of the commenters were opposed, most on the basis
that individuals under the age of 21 lacked the maturity and judgment
to operate a CMV. None explained how interstate drivers under 21 would
diminish safety when most States have concluded that intrastate drivers
under 21 do not do so. Very few truck drivers and motor carriers
commented, but most of them also opposed the pilot program.
    The following language appeared in the Senate Report accompanying
the Fiscal Year (FY) 2003 Department of Transportation Appropriations
bill: ``Given the fact that young drivers are overrepresented in motor
vehicle crashes, the Committee is not convinced of the merits of this
proposal. Prior to the approval of such a pilot program, the Committee
directs the FMCSA Administrator to conduct a thorough analysis of the
safety ramifications and whether there's a genuine shortage of truck
drivers to warrant such a waiver of the Federal safety regulations.''
[Senate Report No. 107-224, July 26, 2002].
    On June 9, 2003 (68 FR 34467, 34468), FMCSA denied the TCA petition
stating that ``the Agency does not have sufficient information at this
time to

make a determination that the safety measures in the pilot program are
designed to achieve a level of safety equivalent to, or greater than,
the level of safety provided by complying with the minimum 21-year age
requirement to operate a CMV.''

IV. Structure of the Proposed Pilot Program

    The purpose of this proposed 3-year pilot program is to determine
whether persons under the age of 21 can safely operate CMVs in
interstate commerce, and to enhance opportunities for persons with
relevant military training to enter the CMV industry. While many
intrastate CMV drivers are already in this age group, the Agency is not
aware of any studies or published reports comparing their safety
performance with that of drivers over 21, either interstate or
intrastate. This pilot program proposes to utilize a study group of
drivers under the age of 21, who have trained on and operated heavy
vehicles while in military service. Because many service personnel
leave active duty while close to or over the age of 21, it is likely
that most study group members would be reservists or National Guard
members. Persons who meet the qualifications described later in this
notice may apply to a participating motor carrier for study group
sponsorship, which, if approved, would allow the individual to operate
a CMV in interstate commerce for that carrier before age 21. To have a
statistically valid sample of drivers under the age of 21,
approximately 200 study group participants are desired. When these
individuals reach the age of 21, they would no longer participate in
the pilot program and would be replaced by new study group members
meeting the eligibility requirements. The length of time during which
replacement study group members will be added will be determined by
FMCSA based on the statistical and administrative needs of the pilot
data collection plan.
    Participating carriers that meet the qualifications described later
in this notice would sponsor study group members and perform other
duties related to the pilot, such as filing certain reports and
recruiting existing drivers to participate as control group members. To
reduce the administrative effort involved, FMCSA anticipates that a
fairly small number of carriers would be selected to participate.
    The control group of older drivers would be needed to form a
baseline of comparison for the safety records of the younger study
group drivers. The control group participants would be 21 years of age
and older, would have received formal CMV driving training comparable
to that of the study group members, and would have similar lengths of
driving experience. These control group members working for the same
participating carriers would volunteer as the study group members. As a
participating carrier receives approval from FMCSA for a qualifying
younger employee to be in the study group, the carrier would then
submit a qualifying, existing employee for inclusion in the control
group. In this manner, an approximately equal number of drivers would
be accepted by FMCSA for each group.
    Carriers would be required to install and operate electronic
logging devices (ELDs) on all vehicles operated by study and control
group drivers. Data from these devices, such as vehicle miles traveled
(VMT), is essential to analyze driving safety records.
    In addition to identification data for all participants, FMCSA
would gather safety data for all study and control group drivers during
the pilot, such as crashes and driving and inspection violations.
Because the amount of data of this nature that can be collected in 3
years may be comparatively small, FMCSA would also consider requesting
participating carriers that have onboard monitoring systems (OBMSs) to
share that data. The safety-critical events (SCEs) \2\ recorded by
OBMSs may provide valuable information on drivers' operating
performance. The use of OBMSs would be based on the willingness of
carriers and drivers to participate and the existing equipment in the
carrier's cabs. FMCSA specifically seeks comments on this option.
---------------------------------------------------------------------------

    \2\ Safety-critical events include crashes, near-crashes, and
crash-relevant conflicts.
---------------------------------------------------------------------------

    FMCSA would reserve the right to select the carriers to participate
and continue in the pilot, as well as to approve the members of the
study and control groups.

V. Management of the Proposed Pilot Program; the Working Group

    Section 5404 of the FAST Act requires the Secretary to ``. . .
conduct, monitor, and evaluate . . .'' the pilot program in
consultation with a working group consisting of representatives of the
armed forces, industry, drivers, safety advocacy organizations, and
State licensing and enforcement officials. The organization and
appointment of this working group would take place under existing
Departmental policies and procedures.
    FMCSA would designate a project manager for the pilot program and
review applications for this program. Approved participating carriers
would be publicly announced on the Agency's Web site to encourage
potential study group members (i.e., drivers) to apply through the
identified carriers for participation. Approved carriers would be able
to assist potential study group drivers (whom they sponsor) with
completion of the application and participation agreement. When a
carrier receives notification that a qualifying study group member has
been approved by FMCSA, the carrier would then submit a form and
agreement for a control group driver. In this manner, the number of
drivers in each group would be similar; i.e., about 200 in the study
group and 200 in the control group. FMCSA would develop the
applications, agreements, and forms to be used by interested carriers
and potential study and control group members.
    Eligibility requirements and procedural matters are discussed later
in this notice.

VI. Proposed Eligibility Criteria To Participate

A. Motor Carriers
    Details of each requirement for motor carriers summarized below
would be published if the pilot program is approved. Interested motor
carriers would be required to:
     Volunteer during the announced application period.
     Be able to supply control group drivers in numbers
matching the study group drivers to be employed.
     Agree to comply with all pilot program procedures.
     Agree to submit required pilot program data and reports.
     Purchase, install and operate an ELD in each truck used in
the pilot program study.
     Monitor and report safety records of study and control
group members as required by FMCSA.
     Have a good safety record, to include appropriate Safety
Measurement System (SMS) status, registration, operating authority,
financial responsibility, and other Agency records.
B. Under-21 Applicants (Study Group Drivers)
    Details of each requirement for study group applicants summarized
below would be published if the pilot program is approved. Interested
drivers would be required to:
     Volunteer.
     Be 18, 19, or 20 years of age as of the date they are
approved by FMCSA for participation.

     Have certification from a military service of training and
experience in driving heavy vehicles while in military service, as
described in Section IX of this notice.
     Agree to the release of specific information to FMCSA for
purposes of the pilot.
     Agree to the use of ELDs.
     Have no disqualifications, suspensions, or license
revocations within past 3 years; or be under any out-of-service order.
     Meet all FMCSR requirements (except age) for operating a
CMV in interstate commerce.
     Operate primarily in interstate commerce if selected.
     Not transport passengers or hazardous materials, or
operate double- or triple-trailer combinations or cargo tank vehicles
while participating in the pilot, regardless of any license
endorsements held.
C. Control Group Drivers
    Details of each requirement for control group drivers summarized
below would be published if the pilot program is approved. Control
group drivers would be required to:
     Volunteer.
     Possess a valid CDL.
     Be a full-time driver for participating motor carrier.
     Have no disqualifications, suspensions, or license
revocations within past 3 years; or be under any out-of-service order.
     Agree to the use of ELDs.
     Agree to release of specified information for pilot
program.
     Have training and experience comparable to study group
drivers, regardless of the source.
     Be 21 to 26 years old at time of acceptance into the
pilot.

VII. Application Process

A. Motor Carriers
     Contact the pilot project manager to arrange a brief no-
obligation preliminary interview via telephone.
     Complete and file with FMCSA the application for
participation that is proposed to include identification information on
the carrier; number of study/control group participants the carrier is
willing to sponsor; nature of duties of study and control group
drivers, to include reporting typical hours worked and miles traveled.
     Designate a pilot program coordinator.
B. Under-21 Applicants (Study Group Drivers)
     Obtain from commanding officer, or his or her official
designee, a certification \3\ that the applicant had formal training
and experience in the operation of heavy motor vehicles while in
military service.
---------------------------------------------------------------------------

    \3\ Form to be developed.
---------------------------------------------------------------------------

     Contact approved participating carrier(s) to determine the
availability of positions and their qualification requirements.
     Complete any documents prescribed by FMCSA for
participation.
C. Control Group Drivers
     Participating carriers would solicit qualifying volunteer
drivers from among existing employees in numbers equal to study group
participants; and
     Complete any documents prescribed by FMCSA for
participation.

VIII. Data Collection Plan

    Details of the data collection plan for this proposed pilot program
would be developed based on comments to the docket and further review
by analysts. The factors to be collected from each participating driver
before and during the pilot program may include, but are not limited
to, (1) details of any past CMV driving experience and demographic
information, to assess qualification for participation in the study
and/or control groups; (2) crashes (to be specified); (3) any traffic
citations or warnings received while driving a CMV; (4) any violations
or warnings listed on a CMV inspection report when the participating
driver was operating the vehicle, and (5) detailed 24-hour records of
activity to include CMV hours-of-service logs or electronic records.
Some of this information normally should be automatically reported to
FMCSA; however, due to possibility of delays in reporting and
inaccurate data in some instances, the participating carrier would be
asked to collect the information from all participating drivers and
report it to FMCSA in a designated format. Other information that may
be needed, such as VMT, would also be collected through the
participating carrier. Every effort would be made to minimize the
burden on the carrier in collecting and reporting this data.

IX. Armed Forces Heavy-Vehicle Driver Training Programs

    Four branches of the Department of Defense--the Army, Air Force,
Navy, and Marine Corps--provide specific training dedicated to
operating heavy-duty vehicles. There are three basic job training
classifications with additional training for other types of heavy-duty
specialty vehicles (e.g., gasoline haulers, construction vehicles, and
military equipment transport oversize/overweight [non-track vehicles]).
    There are four core training programs for heavy vehicle operations,
based on the occupational specialty code of the service member:
     Army--88M--Motor Transport Operator.
     Air Force--2T1--Vehicle Operations.
     Marine Corps--3531--Motor Vehicle Operator.
     Navy--EO--Equipment Operator.
    These four are not the only occupational specialty codes that the
Agency may designate to participate in the pilot. Comments and data are
requested for additional military occupational specialty codes or
equivalent that should be included.
Army--88M Training
    The 88M Instructor Training Manual is 142 pages long. The student
manual--STP 55-88M14-SM-TG Soldier's Manual and Trainer's Guide 88M,
Motor Transport Operator--is 229 pages long and includes 4 levels of
training. The 6-week core curriculum of the Army 88M course contains a
total of 221 hours of training, including:
     Lecture--32 classroom hours.
     Practical application--road driving--189 hours.
    Motor Transport Operators are primarily responsible for operating
wheeled vehicles to transport personnel and cargo. Motor Transport
Operator duties include: Interior components/controls and indicators;
basic vehicle control; driving vehicles over all types of roads and
terrain, traveling alone or in convoys; braking, coupling, backing, and
alley docking; adverse/tactical driving operations; pre-trip
inspections; reading load plans; checking oil, fuel and other fluid
levels, as well as tire pressure; operations in automatic and manual
modes; crash prevention; safety check procedures; basic vehicle
maintenance and repairs; transporting hazardous materials; and keeping
mileage records.
Air Force--2T1--Vehicle Operations
    The Air Force Tractor Trailer Plan of Instruction (POI) is 226
pages long. The minimum length of instruction for the basic school is
84 hours, including 22 hours of classroom and 62 hours of hands-on
activity, both alone on a training pad and on the road with an
instructor. The core curriculum is based on the material in the
American Association of Motor Vehicle Administrators (AAMVA) CDL
Manual--2005 edition (2014 revised). Students participating in the
basic 2T1 curriculum learn general principles in

the classroom. Specialized training occurs at the installation using
the Tractor Trailer Plan of Instruction. A minimum of 40 hours over-
the-road time is expected on each vehicle/trailer type.
    Topics covered in the Air Force Vehicle Operations course include:
Overview of training and Federal requirements; Federal motor vehicle
safety standards; tractor/trailer design; hazards and human factors
relative to the environment where used; safety clothing and equipment;
driving safely; pre- and post-trip vehicle inspection; basic vehicle
control; shifting gears; managing space and speed; driving in
mountains, fog, winter, very hot weather, and at night; railroad
crossings; defensive awareness to avoid hazards and emergencies; skid
control and recovery; what to do in case of a crash; fires; staying
alert and fit to drive; hazardous materials--rules for all commercial
drivers; preparing, inspecting, and transporting cargo safely;
inspecting and driving with air brakes; driving combination vehicles
safely; and coupling and uncoupling.
Marine Corps--3531--Motor Vehicle Operator
    The core curriculum of the Marine Corps 3531 course--TM 11240-15/3G
contains three training areas:
     Lecture--24 classroom hours.
     Demonstration--classroom/training pad--35 hours.
     Practical application--road driving--198 hours.
    Instructional breakout includes:
     Demonstration: 35 hours.
     Guided discussion: 1.5 hours.
     Lecture: 24 hours.
     Performance examination: 62 hours.
     Practical application (individual): 198 hours.
     Written examination: 7 hours.
    Classroom instruction includes lectures, demonstration, and
practice time for the specific tasks identified. Each classroom session
includes written and performance evaluations to ensure students have
mastered all of the learning objectives for the specialty proficiency.
Training includes both simulators and actual vehicle operation.
Practical training includes on-the-road and skills operations, ground
guide procedures, and operating a vehicle with a towed load. Students
practice their driving and backing, with and without a trailer.
Instructors ride with the students as they operate on approved road
routes. Specific training areas (pads) are set aside for the students
to practice their backing skills and ground guide procedures safely.
    The Marine Corps training curriculum also includes emergency
procedures and cargo loading.
Navy--EO--Equipment Operator
    The core curriculum of the USN Heavy Vehicle Operator (Truck
Driver) (EO) course (53-3032.00) is designed to train Navy personnel
how to operate passenger and cargo vehicles to rated capacity. They
palletize, containerize, load and safely transport various types of
cargo and demonstrate knowledge and skills for qualifying as a driver
journeyman. The complete program covers topics including:

 Hazardous materials transportation
 Line haul planning
 Manual tractor-truck operations
 Vehicle Recovery Operations

    The course is taught over 160 hours including 30 hours classroom
and 130 hours lab (behind the wheel). By completing this course, the
Navy driver will be able to:
    1. Perform the duties of normal, non-combat conditions driving in
accordance with the local state driver licensing agency's CDL driver
handbook;
    2. Manage hazardous petroleum, oils and lubricants (POL) material
required during line haul and worksite activities, to support normal,
non-combat operations;
    3. Perform preventive maintenance on a non- or up-armored manual
truck tractor with drop-neck trailer, consisting of pre-start, during-
operations, and after-operations equipment checks, to support normal,
non-combat operations, in accordance with local State Driver License
Agency CDL handbooks;
    4. Operate vehicle controls of a non- or up-armored manual truck-
tractor, to support normal, non-combat operations; and
    5. Be proficient with the components and controls of a drop-neck
trailer relative to a detached/attached gooseneck and a coupled/
uncoupled trailer.
    Other topics covered within the Navy EO training program include:

 Development and maintenance of operational records
 Operation of high mobility multi-purpose wheeled vehicles
 Weight distribution and load securement
 Loading bulk and container cargo
 Preventive maintenance
 Pre- and post- trip vehicle safety inspections

X. Paperwork Reduction Act

    The proposed pilot program would require participating motor
carriers to collect, maintain, and report to FMCSA certain information
about their employed/sponsored drivers who are participating in the
pilot program. This would include identifying information and safety
performance data for use in analyzing the drivers' safety history. The
Agency would develop forms to promote uniformity in the data collected
by the pilot carriers.
    The Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520)
prohibits agencies from conducting information collection (IC)
activities until they analyze the need for the collection of
information and how the collected data would be managed. Agencies must
also analyze whether technology could be used to reduce the burden
imposed on those providing the data. The Agency must estimate the time
burden required to respond to the IC requirements, such as the time
required to complete a particular form. The Agency submits its IC
analysis and burden estimate to the Office of Management and Budget
(OMB) as a formal information collection request (ICR); the Agency
cannot conduct the information collection until OMB approves the ICR.
    FMCSA asks for comment on the IC requirements of this proposal. The
Agency's analysis of these comments would be used in devising the
Agency's estimate of the IC burden of the pilot program. Comments can
be submitted to the docket as outlined under ADDRESSES at the beginning
of this notice. Specifically, the Agency asks for comment on: (1) How
useful the information is and whether it can help FMCSA perform its
functions better; (2) how the Agency can improve the quality of the
information being collected; (3) the accuracy of FMCSA's estimate of
the burden of this IC; and (4) how the Agency can minimize the burden
of collection.
    Because this is a proposed pilot program in which certain aspects--
such as the content of forms and reports--have not been finalized, the
Agency is not posting possible IC burden data at this time. If the
pilot program is to be implemented, this information would be posted at
a later date and additional comments would be taken.

XI. Removal From the Program

    FMCSA reserves the right to remove any motor carrier or driver from
the pilot program for reasons including, but not limited to, failing to
meet any of the requirements of the program.

XII. Request for Public Comments

    The following questions identify input desired by FMCSA.
Instructions

for filing comments to the public docket are included earlier in this
notice. Persons are encouraged to respond wherever possible, but
comments are not limited to replies to these questions:
    1. Are any additional safeguards needed to ensure that the pilot
program provides a level of safety equivalent to that without the age
exemption?
    2. Would carriers be able to obtain enough volunteer drivers to
serve in the control group?
    3. Do ``comparable levels of training and experience'' need to be
defined more precisely? If so, what levels would you suggest?
    4. Are traffic violations, crashes, and inspection violations
adequate to allow a comparison of safety records? If not, what other
safety performance measures should be included?
    5. If drivers reach age 21 while in the study group, should they be
removed from the pilot and replaced with a different driver meeting the
eligibility criteria?
    6. Are the data collection efforts proposed so burdensome for
carriers as to discourage their participation?
    7. Are there carriers currently using onboard monitoring on all
their CMVs that are willing to participate in the study? Is onboard
monitoring of pilot program drivers needed to assess their safety
performance?

    Issued on: August 11, 2016.
T.F. Scott Darling, III,
Administrator.
[FR Doc. 2016-19948 Filed 8-19-16; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 75, Number 239 (Tuesday, December 14, 2010)]
[Proposed Rules]
[Pages 77799-77801]
[FR Doc No: 2010-31330]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[EPA-HQ-OAR-2008-0334; FRL-9238-6]

National Emission Standards for Hazardous Air Pollutants for
Chemical Manufacturing Area Sources

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: On June 15, 2010, EPA notified Petitioners that the Agency
intended to initiate the reconsideration process in response to their
request for reconsideration of certain provisions in the National
Emission Standards for Hazardous Air Pollutants for Chemical
Manufacturing Area Sources. Among the provisions that EPA is
reconsidering is a requirement that certain affected sources obtain a
permit. In a separate rule published today, EPA is taking final action
to stay for 90 days, the requirement for certain affected sources to
comply with the title V permit program. Because we believe the
reconsideration process may not be completed within 90 days, we are
proposing to stay the provision requiring certain sources to obtain a
permit until the final reconsideration rule is published in the Federal
Register. EPA is requesting public comment on this proposed stay.

DATES: Comments. Comments must be received on or before January 28,
2011.
    Public Hearing. If anyone contacts EPA requesting to speak at a
public hearing by December 27, 2010, a public hearing will be held on
December 29, 2010. For further information on the public hearing and
requests to speak, see the ADDRESSES section of this preamble.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2008-0334, by one of the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>Attention Docket ID No.
EPA-HQ-OAR-2008-0334.
     Fax:<PHONE_NUMBER>, Attention Docket ID No. EPA-HQ-OAR-
2008-0334.
     Mail: U.S. Postal Service, send comments to: Air and
Radiation Docket and Information Center, Environmental Protection
Agency, Mailcode: 2822T, 1200 Pennsylvania Ave., NW., Washington, DC
20460, Attention Docket ID No. EPA-HQ-OAR-2008-0334.

     Hand Delivery: In person or by courier, deliver comments
to: EPA Docket Center (2822T), Room 3334, 1301 Constitution Ave., NW.,
Washington, DC 20004. Such deliveries are only accepted during the
Docket's normal hours of operation, and special arrangements should be
made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2008-0334. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
confidential business information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket, visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the EPA Docket Center,
EPA West Building, Room 3334, 1301 Constitution Ave., NW., Washington,
DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Public Reading Room is<PHONE_NUMBER>, and the telephone number for the
Docket Center is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Mr. Randy McDonald, Office of Air
Quality Planning and Standards, Sector Policies and Programs Division,
Coatings and Chemicals Group (E143-01), Environmental Protection
Agency, Research Triangle Park, NC 27711, telephone number: (919) 541-
5402; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The EPA published final National Emission Standards for Hazardous
Air Pollutants for Chemical Manufacturing Area Sources on October 29,
2009. 40 CFR part 63, subpart VVVVVV (74 FR 56008). Included in the
final rule was a new provision requiring any major source that had
installed a control device on a chemical manufacturing process unit
after November 15, 1990, and, as a result, became an area source under
CFR 40 part 63 to obtain a title V permit under 40 CFR part 70 or 40
CFR part 71. See 40 CFR 63.11494(e).
    On February 12, 2010, the American Chemistry Council and the
Society of Chemical Manufacturers and Affiliates (collectively referred
to as ``Petitioners'') sought reconsideration of six provisions in the
final rule, including the provision requiring certain sources to obtain
a title V permit. On June 15, 2010, EPA notified Petitioners that the
Agency intended to initiate the reconsideration process. EPA also
separately notified Petitioners that the provision requiring certain
sources to obtain a title V permit was among the provisions for which
EPA would grant reconsideration.
    By letter dated October 28, 2010, Petitioners requested a stay of
the requirement to comply with the title V permit program, specifically
the requirement to submit a title V permit application, pending
completion of the reconsideration process. Petitioners stated in their
letter that they were requesting the stay because EPA has yet to
initiate the reconsideration process and, ``under one interpretation of
EPA's [40 CFR part 70 and 40 CFR part 71] regulations, existing sources
must file Title V permit applications [by] October 29, 2010.''
Petitioners maintained that it would be unreasonable and inequitable to
require facilities to prepare and submit title V applications at the
same time that EPA is reconsidering the requirement to obtain a title V
permit. As explained below, EPA believes that it is appropriate to stay
the effectiveness of the requirement in 40 CFR 63.11494(e) for certain
sources to obtain a title V permit during the pendency of the
reconsideration process.
    EPA is proposing to stay the provision in 40 CFR 63.11494(e) that
requires ``[a]ny source that was a major source and installed a control
device on a CMPU \1\ after November 15, 1990, and, as a result, became
an area source under 40 CFR part 63 is required to obtain a permit
under 40 CFR part 70 or 40 CFR part 71.'' We are proposing to stay the
provision until after the final reconsideration rule is published in
the Federal Register. This provision was first introduced in the final
rule and represented a significant change from the proposal. Facilities
had no chance to comment on this new requirement in the final rule. We
are proposing to stay this provision because both the affected universe
of sources and the substantive requirement could change as a result of
this reconsideration process. Specifically, we will be reconsidering
whether the affected sources noted above should be subject to title V,
or whether they should be exempt from title V requirements. Because we
cannot pre-judge the outcome of the reconsideration process, we think a
limited stay during the duration of the administrative reconsideration
process is appropriate so that sources are not incurring the cost
associated with applying for a title V permit in advance of our final
decision on the issue.
---------------------------------------------------------------------------

    \1\ Chemical manufacturing process unit.
---------------------------------------------------------------------------

II. Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action,'' and, therefore, is
not subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). In
addition, this action does not impose any enforceable duty or contain
any unfunded mandate as described in the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104-4), or require prior consultation with State
officials, as specified by Executive Order 12875 (58 FR 58093, October
28, 1993), or involve special consideration of environmental justice
related issues, as required by Executive Order 12898 (59 FR 7629,
February 16, 1994). Pursuant to the Regulatory Flexibility

Act, I certify that this action will not have a significant economic
impact on a substantial number of small entities. This proposed rule
will not impose any new requirements on any entities because it does
not impose any additional regulatory requirements. This action also
does not have Tribal implications because it will not have a
substantial direct effect on one or more Indian Tribes, on the
relationship between the Federal government and Indian Tribes, or on
the distribution of power and responsibilities between the Federal
government and Indian Tribes, as specified by Executive Order 13175 (65
FR 67249, November 9, 2000). This action also does not have Federalism
implications because it does not have substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132 (64
FR 43255, August 10, 1999). This action also is not subject to
Executive Order 13045 ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997). The
requirements of section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This action
does not impose an information collection burden under the provisions
of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501, et seq.). EPA's
compliance with these statutes and Executive Orders for the underlying
rule is discussed in the October 29, 2009, Federal Register document.

List of Subjects in 40 CFR Part 63

    Environmental protection, Administrative practice and procedure,
Air pollution control, Monitoring, Reporting and recordkeeping.

    Dated: December 7, 2010.
Lisa P. Jackson,
Administrator.
[FR Doc. 2010-31330 Filed 12-13-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 190 (Monday, October 1, 2018)]
[Notices]
[Pages 49407-49408]
[FR Doc No: 2018-21321]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2018-0014; OMB No. 1660-0073]

Agency Information Collection Activities: Proposed Collection;
Comment Request; National Urban Search and Rescue Response System

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Correction notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, this
notice seeks comments concerning the Urban Search and Rescue Response
System information collection. A notice for this collection was
previously published as an extension, without change, of a currently
approved collection. However, a change has since been made, and this
collection is now being submitted to the Office of Management and
Budget for review and

clearance as a revision of a currently approved collection. The Federal
Emergency Management Agency, as part of its continuing effort to reduce
paperwork and respondent burden, invites the general public to take
this opportunity to comment on a revision of a currently approved
information collection.

DATES: Comments must be submitted on or before November 30, 2018.

ADDRESSES: To avoid duplicate submissions to the docket, please use
only one of the following means to submit comments:
    (1) Online. Submit comments at www.regulations.gov under Docket ID
FEMA-2018-0014. Follow the instructions for submitting comments.
    (2) Mail. Submit written comments to Docket Manager, Office of
Chief Counsel, DHS/FEMA, 500 C Street SW, 8NE, Washington, DC 20472-
3100.
    All submissions received must include the agency name and Docket
ID. Regardless of the method used for submitting comments or material,
all submissions will be posted, without change, to the Federal
eRulemaking Portal at http://www.regulations.gov, and will include any
personal information you provide. Therefore, submitting this
information makes it public. You may wish to read the Privacy Act
notice that is available via the link in the footer of
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Wanda Casey, Chief, Program Management
Section, US&R Branch, FEMA, Response Directorate, Operations Division,
at<PHONE_NUMBER>. You may contact the Information Management Division
for copies of the proposed collection of information at email address:
[email protected].

SUPPLEMENTARY INFORMATION: Section 303 of the Robert T. Stafford
Disaster Relief and Emergency Assistance Act (Stafford Act), 42 U.S.C.
5144, authorizes the President of the United States to form emergency
support teams of Federal personnel to be deployed to an area affected
by major disaster or emergency. Section 403(a)(3)(B) of the Stafford
Act provides that the President may authorize Federal Agencies to
perform work on public or private lands essential to save lives and
protect property, including search and rescue and emergency medical
care, and other essential needs. Section 327 of the Stafford Act
further authorizes the National US&R Response System (``the System'')
and outlines the Administrator's authorization to designate teams as
well as outlines specific protections for System members.
    The information collection activity is authorized under the OMB
circular, 2 CFR part 200, ``Uniform Administrative Requirements, Cost
Principles, and Audit Requirements for Federal Awards.'' The collection
contains information from the programmatic and administrative
activities of the US&R Sponsoring Agencies relating to the readiness
and response cooperative agreement awards. FEMA proposes to update FEMA
Form 089-0-10 to remove all instances requesting ``name.''

Collection of Information

    Title: National Urban Search and Rescue Response System.
    Type of Information Collection: Revision of a currently approved
information collection.
    OMB Number: 1660-0073.
    FEMA Forms: FEMA Form 089-0-10, Urban Search Rescue Response System
Narrative Statement Workbook; FEMA Form 089-0-11, Urban Search Rescue
Response System Semi-Annual Performance Report; FEMA Form 089-0-12,
Urban Search Rescue Response System Amendment Form; FEMA Form 089-0-14,
Urban Search Rescue Response System Task Force Self-Evaluation
Scoresheet; FEMA Form 089-0-15, Urban Search Rescue Response System
Task Force Deployment Data; FEMA Form 089-0-26, Vehicle Support Unit
Purchase/Replacement/Disposal Justification.
    Abstract: The information collection activity is the collection of
financial, program, and administrative information for US&R Sponsoring
Agencies relating to readiness and response for Cooperative Agreement
awards.
    Affected Public: State, Local, or Tribal Government.
    Estimated Number of Respondents: 154.
    Estimated Number of Responses: 210.
    Estimated Total Annual Burden Hours: 392.
    Estimated Total Annual Respondent Cost: $20,654.48.
    Estimated Respondents' Operation and Maintenance Costs: $0.
    Estimated Respondents' Capital and Start-Up Costs: $0.
    Estimated Total Annual Cost to the Federal Government: $121,403.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.

William H. Holzerland,
Sr. Director, Information Management Division, Mission Support, Federal
Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2018-21321 Filed 9-28-18; 8:45 am]
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[Federal Register Volume 82, Number 229 (Thursday, November 30, 2017)]
[Notices]
[Pages 56828-56829]
[FR Doc No: 2017-25780]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2015-E-3316 and FDA-2015-E-3315]

Determination of Regulatory Review Period for Purposes of Patent
Extension; ADVANTAME

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for ADVANTAME and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that food
additive.

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by January
29, 2018. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by May 29, 2018. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
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 January 29, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of January 29, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos.
FDA-2015-E-3316 and FDA-2015-E-3315 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; ADVANTAME.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, human biologic product,

animal drug product, medical device, food additive, or color additive)
was subject to regulatory review by FDA before the item was marketed.
Under these acts, a product's regulatory review period forms the basis
for determining the amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For food and color additive
products, the testing phase begins on the date a major health or
environmental effects test is begun and runs until the approval phase
begins. The approval phase begins on the date a petition relying on the
major health or environmental effects test and requesting the issuance
of a regulation for use of the additive under section 409 or 721 of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) is initially
submitted to FDA and ends upon whichever of the following occurs last:
(i) The regulation for the additive becomes effective; or (ii)
objections filed against the regulation that result in a stay of
effectiveness are resolved and commercial marketing is permitted; or
(iii) proceedings resulting from objections to the regulation, after
commercial marketing has been permitted and later stayed pending
resolution of the proceedings, are finally resolved and commercial
marketing is permitted.
    Although only a portion of a regulatory review period may count
toward the actual amount of extension that the Director of USPTO may
award (for example, half the testing phase must be subtracted as well
as any time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a food
and color additive will include all of the testing phase and approval
phase as specified in 35 U.S.C. 156(g)(2)(B).
    FDA has approved for marketing the food additive ADVANTAME.
ADVANTAME may be safely used as a sweetening agent and flavor enhancer
in foods generally, except in meat and poultry, in accordance with
current good manufacturing practice, in an amount not to exceed that
reasonably required to achieve the intended technical effect, in foods
for which standards of identity established under section 401 of the
FD&C Act do not preclude such use. Subsequent to this approval, the
USPTO received patent term restoration applications for ADVANTAME (U.S.
Patent Nos. 6,548,096 and 7,141,263) from Ajinomoto Co., Inc., and the
USPTO requested FDA's assistance in determining the patents'
eligibility for patent term restoration. In a letter dated October 30,
2015, FDA advised the USPTO that this food and color additive had
undergone a regulatory review period and that the approval of ADVANTAME
represented the first permitted commercial marketing or use of the
product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
ADVANTAME is 4,967 days. Of this time, 3,091 days occurred during the
testing phase of the regulatory review period, while 1,876 days
occurred during the approval phase. These periods of time were derived
from the following dates:
    1. The date a major health or environmental effects test on the
food additive was initiated: October 16, 2000. FDA has verified the
Ajinomoto Co., Inc. claim that October 16, 2000, is the date the major
health or environmental effects test was begun.
    2. The date a petition relying on the major health or environmental
effects test and requesting the issuance of a regulation for use of the
additive under section 409 or 721 of the Federal Food Drug, and
Cosmetic Act is initially submitted to FDA: April 2, 2009. The
applicant claims that the food additive petition (FAP) for ADVANTAME
(FAP 9A4778) was submitted on March 30, 2009. However, according to FDA
records, FAP 9A4778 was submitted on April 2, 2009, when a complete
application was received.
    3. The date the regulation for the additive becomes effective or
the date objections filed against the regulation that result in a stay
of effectiveness are resolved and commercial marketing is permitted, or
the date proceedings resulting from objections to the regulation after
commercial marketing has been permitted and later stayed pending
resolution of the proceedings, are finally resolved and commercial
marketing is permitted: May 21, 2014.
    FDA has verified the applicant's claim that FAP 9A4778 became
effective on May 21, 2014.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 5 years of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition comply with all the requirements of
Sec.  60.30, including but not limited to: must be timely (see DATES),
must be filed in accordance with Sec.  10.20, must contain sufficient
facts to merit an FDA investigation, and must certify that a true and
complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: November 22, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25780 Filed 11-29-17; 8:45 am]
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[Federal Register Volume 82, Number 160 (Monday, August 21, 2017)]
[Notices]
[Page 39589]
[FR Doc No: 2017-17567]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-2363]

Electronic Study Data Submission; Data Standards; Support for
Standard for Exchange of Nonclinical Data Implementation Guide Version
3.1

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for
Drug Evaluation and Research (CDER) is announcing support for the 3.1
version of Clinical Data Interchange Standards Consortium (CDISC)
Standard for Exchange of Nonclinical Data (SEND IG 3.1), the end of
support for the 3.0 version of SEND IG, and an update to the FDA Data
Standards Catalog (Catalog). (See http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm.) SEND IG 3.1 has been
available from CDISC (www.cdisc.org) since July 2016. FDA is
encouraging sponsors and applicants to use SEND IG 3.1 in
investigational study data provided in regulatory submissions to CDER.

FOR FURTHER INFORMATION CONTACT: Ron Fitzmartin, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1115, Silver Spring, MD 20993-0002, 301-
796-5333, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On December 17, 2014, FDA published final guidance for industry
entitled ``Providing Regulatory Submissions in Electronic Format--
Standardized Study Data'' (eStudy Data), posted on FDA's Study Data
Standards Resources Web page at https://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm. The eStudy Data guidance
implements the electronic submission requirements of section 745A(a) of
the Food, Drug and Cosmetic Act (21 U.S.C. 379k-1(a)) for study data
contained in new drug applications (NDAs), abbreviated new drug
applications (ANDAs), biologics license applications (BLAs), and
investigational new drug applications (INDs) to FDA's Center for
Biologics Evaluation and Research or CDER by specifying the format for
electronic submissions. The initial timetable for implementing
electronic submission requirements for study data was December 17, 2016
(24 months after issuance of final guidance for NDAs, BLAs, ANDAs, and
36 months for INDs). The eStudy Data guidance states that a Federal
Register notice will specify the transition date for all version
updates (with the month and day for the transition date corresponding
to March 15).
    The transition date for support of version 3.1 of CDISC SEND IG is
March 15, 2018. Although SEND IG version 3.1 is supported as of this
Federal Register notice and sponsors or applicants are encouraged to
begin using it, the new version will only be required in submissions
for studies that start after March 15, 2019. The Catalog will list
March 15, 2019, as the ``date requirement begins.'' When multiple
versions of an FDA-supported standard are listed in the Catalog,
sponsors or applicants can select a version to use.
    The transition date for the end of FDA support for SEND IG 3.0 is
March 15, 2018. Therefore, FDA support for SEND IG 3.0 will end for
studies that start after March 15, 2019. The Catalog will be updated to
list March 15, 2019, as the ``date support ends.''

II. Electronic Access

    Persons with access to the Internet may obtain the referenced
material at https://www.fda.gov/ectd.

    Dated: August 15, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-17567 Filed 8-18-17; 8:45 am]
 BILLING CODE 4164-01-P