[Federal Register: April 11, 2008 (Volume 73, Number 71)]
[Notices]
[Page 19934-19936]
[DOCID:fr11ap08-138]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2008-22720 (Notice No. 08-04)]

Hazardous Materials Instructor Training Grants Program;
Availability of Funds

AGENCY: Pipeline and Hazardous Materials Safety Administration, DOT.

ACTION: Notice.

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SUMMARY: The Pipeline and Hazardous Materials Safety Administration
(PHMSA) announces the availability of funds and solicitation of
applications for grants to be awarded under the Hazardous Materials
Instructor Training (HMIT) Grants Program for fiscal year 2009. The
HMIT Grants Program is open to non-profit hazardous materials (hazmat)
employee organizations demonstrating expertise in conducting a training
program for hazmat employees, and the ability to reach a target
population of hazmat employees. For the purposes of the HMIT Grants
program, an ``employee organization'' is a labor union, association,
group, or similar organization the members of which are hazmat
employees and the stated purpose of which is to represent hazmat
employees.

DATES: Application packages will be available April 15, 2008. Completed
applications must be submitted by July 15, 2008. Grants will be awarded
in September 2008.

ADDRESSES: Applications may be submitted electronically at http://
www.grants.gov or mailed to Charles G. Rogoff, HMIT Grants Manager,
Office of Hazardous Materials Planning and Analysis; Pipeline and
Hazardous Materials Safety Administration; U.S. Department of
Transportation; Room E23-301; East Building 1200 New Jersey Ave., SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Charles G. Rogoff, HMIT Grants
Manager; Office of Hazardous Materials Planning and Analysis; Pipeline
and Hazardous Materials Safety Administration; U.S. Department of
Transportation; Room E23-301; East Building 1200 New Jersey Ave., SE.,
Washington, DC 20590; Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Availability of Funds. The Hazardous Materials Transportation
Safety and Security Reauthorization Act of 2005 (the Act; Title VII of
Pub. L. 109-59, 119 Stat. 1144 (August 10, 2005)) provides for the
Secretary of Transportation, subject to the availability of funds, to
make grants for training instructors to train hazardous materials
employees (hazmat employees) and, to the extent determined appropriate,
for such instructors to train hazmat employees. The Hazardous Materials
Instructor Training (HMIT) Grants Program is funded by registration
fees collected from certain hazardous materials shippers and carriers
in accordance with 49 CFR Part 107, Subpart G. Approximately $4,000,000
will be awarded in September 2008 for the HMIT Grants Program. These
awards are available for use during a twelve-month budget period
[October 1, 2008 to September 30, 2009]. We expect grant awards to
range from $250,000 to $500,000 depending upon the number and quality
of applications received. We encourage the addition of non-Federal
funds to support the training program, but cost-sharing or matching
funding is not required.
    Objective of the HMIT Grants Program. The objective of the HMIT
Grants Program is to ``train the trainer''--that is, to train hazmat

instructors who will then train hazmat employees in the proper handling
of hazardous materials. Properly planned and maintained training
programs are essential to ensuring that hazmat employees receive an
initial and continuing understanding of the risks involved in
transporting hazardous materials, the relevant requirements that have
to be met, and the need for performing their duties in a way that will
ensure their safety and the safety of others. Experience shows that
effective training of employees can effectively reduce risk and the
likelihood of hazmat incidents. Effective training of employees is key
to ensuring that hazardous materials are transported safely.
    Due to budget and other limitations, many hazmat employees cannot
leave their employment locations for extended periods of time to attend
training courses. Instructors trained under this grant program can
offer training to a large number of hazmat employees at locations
within close proximity to the hazmat employees' places of employment,
thereby significantly minimizing employee travel cost and training
time.
    As provided by the Act, funds awarded to an organization in
accordance with the HMIT Grants Program may be used to train hazmat
instructors and, to the extent determined to be appropriate, for such
instructors to train hazmat employees. PHMSA has determined that,
because we have limited funding available, grants awarded for FY 2009
(October 1, 2008-September 30, 2009) must be used exclusively for
``train the trainer'' programs. Grant funds are not authorized to be
used to fund an organization's existing hazmat training program.
    Eligibility. The HMIT Grants Program is open to non-profit
hazardous materials employee organizations demonstrating: (1) Expertise
in conducting a training program for hazmat employees, and (2) the
ability to reach a target population of hazmat employees. For the
purposes of the HMIT Grants program, an ``employee organization'' is a
labor union, association, group, or similar organization the members of
which are hazardous materials employees and the stated purpose of which
is to represent hazmat employees.
    Two or more non-profit hazmat employee organizations may team
together to submit a joint grant application. A hazmat employee, as
defined under the Hazardous Materials Regulations (HMR; 49 CFR Parts
171-180), is a person who, in the course of full time, part time, or
temporary employment, directly affects hazardous materials
transportation safety. Hazmat employees include self-employed persons,
including owner-operators of motor vehicles, vessel, or aircraft
crewmembers and employees, and railroad signalmen and maintenance-of-
way employees. The term includes a person who:
    (1) Loads, unloads, or handles hazardous materials;
    (2) Designs, manufactures, fabricates, inspects, marks, maintains,
reconditions, repairs, or tests a package, container or packaging
component that is represented, marked, certified, or sold as qualified
for use in transporting hazardous material in commerce.
    (3) Prepares hazardous materials for transportation;
    (4) Is responsible for safety of transporting hazardous materials;
or
    (5) Operates a vehicle used to transport hazardous materials.
    In accordance with Sec.  172.704 of the HMR hazmat employees must
be trained in four areas:
    (1) General awareness/familiarization training providing
familiarity with the requirements of the HMR and enabling the hazmat
employee to recognize and identify hazardous materials consistent with
the hazard communication requirements of the HMR,
    (2) Function-specific training concerning the requirements of the
HMR specifically applicable to the functions performed by the hazmat
employee,
    (3) Safety training including measures to protect the employee from
the hazards associated with the hazardous materials to which he or she
may be exposed in the workplace, and
    (4) Security awareness training providing an awareness of the
security risks associated with hazardous materials transportation and
measures to enhance transportation security.
    For example, function-specific training would include training for
persons who are responsible for preparing shipments for transportation,
including selecting an appropriate packaging, filling the packaging,
applying applicable package marks and labels, and preparing shipping
documentation. Function-specific training would also include training
for persons responsible for performing transportation functions, such
as loading or unloading of containers and transport conveyances. Safety
training would address training related to the specific hazards
associated with the materials to which a hazmat employee may be exposed
and protective measures in the event of an emergency, such as hazards
and protective measures associated with ethanol fuel blends.
    Application requirements. The requirements in 49 CFR Part 19,
``Uniform Administrative Requirements for Grants and Agreements with
Institutions of Higher Education, Hospitals, and other Non-Profit
Organizations'' apply to the HMIT grant program.
    An applicant must address the following factors:
    (1) Qualification as a non-profit hazmat employee organization,
including the type or types of hazmat employees represented and the
number of employees represented.
    (2) Expertise and experience in conducting hazmat employee trainer
education programs.
    (3) Ability to train hazmat instructors to reach and involve a
target population of hazmat employees.
    (4) Training needs assessment for the target population of hazmat
instructors and employees. The purpose of a needs assessment is to
assess the level of understanding held by students and compare this
with the desired level of understanding at the completion of training.
Also required is an estimate of the numbers of instructors and
employees requiring training. The training curriculum and delivery
methods must be flexible enough to address the needs of the students as
determined by the needs assessment.
    (5) Prioritization of training needs based on the needs assessment.
    (6) A training curriculum for the instructors to be trained in the
program and an explanation of how the training will be provided (e.g.,
classroom instruction, self-directed training using booklets, CD or DVD
modules, or computer-based programs). The training curriculum must
include details on the specific HMR training requirements that will be
covered.
    (7) A process for assessing the effectiveness of the training
program(s) and evaluating students. This process will involve a
continuous system for evaluating and monitoring employee competencies
including changes in regulatory requirements, business or operational
practices, introduction of new equipment or procedures or any change in
business processes that require revised or new competencies on the part
of hazmat employees. Course evaluation involves the evaluation of
student performance as well the evaluation of the trainer, and the
training program.
    (8) A process to validate that the training program accomplished
its intended purpose and its objectives were achieved in the most cost
effective

manner. Validation involves the hazmat employer, the hazmat employee
and the trainer and the training organization.
    (9) A statement-of-work describing the amount of funding requested
and the activities for which the funding will be used.
    Review and selection process. A committee of Federal agency
representatives with expertise in hazmat instructor training programs
will evaluate the grant applications. Each grant application will be
evaluated in accordance with the following criteria:
    (1) Organization demonstrates quantified need for training (15%).
    (2) Degree to which the proposed training program meets the
identified training needs (15%).
    (3) Number of instructors to be trained (15%).
    (4) Projected number of hazmat employees each instructor is
expected to train (10%).
    (5) Projected impact of the training in reducing risk and enhancing
hazmat transportation safety (15%).
    (6) Organization's prior experience in providing hazmat instructor
and employee training and the facilities/mechanisms in place to conduct
the training (10%).
    (7) Efficiency and cost associated with conducting the training
(10%)
    (8) Ability to account for program expenditures and program
outcomes (10%).
    The PHMSA Administrator will have the final approval to evaluate
and select applicants and award financial assistance. The agency may
ask an applicant to modify its objectives, work plan, or budget and
provide supplemental information prior to award. The Administrator's
decision is final.

    Issued in Washington, DC on April 7, 2008.
Theodore L. Willke,
Associate Administrator for Hazardous Materials Safety.
 [FR Doc. E8-7703 Filed 4-10-08; 8:45 am]

BILLING CODE 4910-60-P


[Federal Register Volume 78, Number 99 (Wednesday, May 22, 2013)]
[Notices]
[Pages 30297-30298]
[FR Doc No: 2013-12126]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2146-139]

Alabama Power Company; Notice of Application Accepted for Filing
and Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Non-project use of project lands and waters.
    b. Project No: 2146-139.
    c. Date Filed: March 19, 2013.
    d. Applicant: Alabama Power Company.
    e. Name of Project: Coosa River Hydroelectric Project.
    f. Location: Lake Logan Martin in Talladega County, Alabama.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Amy Stewart, Alabama Power Company, 600 18th
Street North, Birmingham, AL, 35203-8180,<PHONE_NUMBER>.
    i. FERC Contact: Mark Carter,<PHONE_NUMBER><EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and
protests: June 14, 2013.
    All documents may be filed electronically via the Internet. See, 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>or toll free at 1-866-208-3676,
or for TTY,<PHONE_NUMBER>. Although the Commission strongly encourages
electronic filing, documents may also be paper-filed. To paper-file,
mail an original and seven copies to: Secretary, Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
Please include the project number (P-2146-139) on any comments or
motions filed.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervenor files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency.
    k. Description of Application: Alabama Power Company (licensee)
requests Commission approval to permit existing and proposed facilities
associated with a recreational vehicle (RV) park operated by Clear
Creek Cove, LLC (permittee) on Lake Logan Martin. The RV park consists
of approximately 15.5 acres of land owned by the permittee, 6.7 acres
of which is located inside the project boundary on lands over which the
licensee holds flowage rights. The licensee previously permitted the
construction of 5 docks with associated concrete access pads and a
playground inside the project boundary. Inside the project boundary,
the permittee also has constructed 11 RV pads with utility connections
(81 additional pads are located outside of the project boundary), a
swimming beach, and portions of an on-site sewage disposal system. The
licensee proposes to permit the above improvements, as well as allow
the permittee to make the following additional improvements: (1)
Install four boat docks measuring 8 feet by 150 feet; (2) re-configure
an existing boat dock; (3) re-purpose an existing boat dock into a
floating pavilion; (4) install a boat ramp; (5) construct a parking
area and access road; (6) install two additional covered pavilions and
a playground on land; and (7) install a walking and cart path. After
the proposed improvements, the RV park could accommodate a total of 88
watercraft.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at http://www.ferc.gov using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field (P-2146) to access the document. You
may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, call 1-866-
208-3676 or email<EMAIL_ADDRESS>for TTY, call (202) 502-
8659. A copy is also available for inspection and reproduction at the
address in item (h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214, respectively. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Documents: Any filing must (1) bear in all
capital letters the title ``COMMENTS'', ``PROTEST'', or ``MOTION TO
INTERVENE'' as applicable; (2) set forth in the heading the name of the
applicant and the project number of the application to which the filing
responds; (3) furnish the name, address, and telephone number of the
person commenting, protesting or intervening; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis. Any filing made by an intervenor must be accompanied
by proof of service on all persons listed in the service list prepared
by the Commission in this proceeding, in accordance with 18 CFR
385.2010.

    Dated: May 15, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-12126 Filed 5-21-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 24 (Wednesday, February 5, 2014)]
[Notices]
[Page 6900]
[FR Doc No: 2014-02475]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL 9905-51-Region 9]

Notice of Proposed Administrative Order on Consent for Waipahu
Ash Landfill, Pearl Harbor Naval Complex Superfund Site (partial),
Oahu, Hawaii

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; request for public comment.

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SUMMARY: In accordance with Section 122(i) of the Comprehensive
Environmental Response, Compensation and Liability Act of 1980, as
amended (``CERCLA''), notice is hereby given of a proposed settlement,
embodied in an Administrative Order on Consent (``Consent Order''),
with the City and County of Honolulu (``CCH''), under Sections 104, 107
and 122 of CERCLA. The Consent Order concerns work to be done by CCH in
connection with the Waipahu Ash Landfill, located in part on the Pearl
Harbor Naval Complex Superfund Site, Joint Base Pearl Harbor-Hickam,
Oahu, Hawaii and on land owned by the State of Hawaii and CCH. Parties
to the Consent Order include the U.S. Environmental Protection Agency
(``EPA''), the Department of the Navy (``Navy''), Hawaii Department
Health (``DOH''), Hawaii Department of Land and Natural Resources and
CCH. The property (the ``Site'') that is the subject of this Consent
Order includes all areas to which hazardous substances from or related
to the now closed Waipahu Ash Landfill have come to be located. Under
this Consent Order, CCH agrees to carry out a remedial investigation
and feasibility study of the Site under CERCLA. The performance of this
work shall be approved and monitored by EPA in Consultation with the
Navy and DOH. The settlement includes a covenant not to sue CCH
pursuant to Sections 106 or 107(a) of CERCLA. Under the Consent Order,
CCH also agrees to pay the Navy $63,062.00 in past response costs and,
to EPA, $25,000 in prepayment of anticipated annual EPA future response
costs.

DATES: Comments must be received on or before March 7, 2014. For thirty
(30) days following the date of publication of this notice, EPA will
consider all comments received on the Consent Order and may modify or
withdraw its consent to the Consent Order if comments received disclose
facts or considerations that indicate that the settlement is
inappropriate, improper, or inadequate.

ADDRESSES: The Consent Order is available for public inspection at the
United States Environmental Protection Agency, Superfund Records
Center, 95 Hawthorne Street, Suite 403S, San Francisco, California
94105. Telephone:<PHONE_NUMBER>. EPA's response to any comments received
will be available for public inspection at the same address.

FOR FURTHER INFORMATION CONTACT: Larry Bradfish, Assistant Regional
Counsel (ORC-3), Office of Regional Counsel, U.S. EPA Region IX, 75
Hawthorne Street, San Francisco, CA 94105; Email:
<EMAIL_ADDRESS>Phone<PHONE_NUMBER>.

    Dated: January 27, 2014.
Enrique Manzanilla,
Director, Superfund Division, EPA Region 9.
[FR Doc. 2014-02475 Filed 2-4-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 118 (Wednesday, June 19, 2019)]
[Notices]
[Pages 28621-28623]
[FR Doc No: 2019-13016]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2019-0093]

Hours of Service of Drivers: Turfgrass Producers International;
Application for Exemption

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

ACTION: Notice of application for exemption; request for comments.

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SUMMARY: FMCSA has received an application from Turfgrass Producers
International (TPI) asking the agency to extend the hours-of-service
(HOS) exemption for agricultural operations to drivers transporting
turfgrass sod for its business operations. FMCSA requests public
comment on TPI's application for exemption.

DATES: Comments must be received on or before July 19, 2019.

ADDRESSES: You may submit comments identified by Federal Docket
Management System Number FMCSA-2019-0093 by any of the following
methods:
     Federal eRulemaking Portal: www.regulations.gov. See the
Public Participation and Request for Comments section below for further
information.
     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.
E.T., 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.
    Docket: For access to the docket to read background documents or
comments, go to www.regulations.gov at any time or visit Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE,
Washington, DC, between 9 a.m. and 5 p.m., ET,

Monday through Friday, except Federal holidays. The on-line FDMS is
available 24 hours each day, 365 days each year.
    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: Ms. Pearlie Robinson, FMCSA Driver and
Carrier Operations Division; Office of Carrier, Driver and Vehicle
Safety Standards; Telephone:<PHONE_NUMBER>; Email<EMAIL_ADDRESS>If
you have questions on viewing or submitting material to the docket,
contact Docket Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation and Request for Comments

    FMCSA encourages you to participate by submitting comments and
related materials.

Submitting Comments

    If you submit a comment, please include the docket number for this
notice (FMCSA-2019-0093), 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 or 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 and put
the docket number, ``FMCSA-2019-0093'' in the ``Keyword'' box, and
click ``Search.'' When the new screen appears, click on ``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.

II. Legal Basis

    FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant
exemptions from certain Federal Motor Carrier Safety Regulations. 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 and provide an opportunity for
public comment on the request.
    The Agency preforms a review of 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
Agency will publish its decision 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 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. Request for Exemption

    Turfgrass Producers International (TPI) represents natural grass
seed and sod farmers throughout the United States and abroad. TPI has
promoted the benefits of natural grass for 51 years and has members in
over 46 States and 25 nations who produce natural grass seed and sod to
service customers and consumers in the green industry. The natural
grass product that farming members produce is delivered to urban and
suburban areas where it is used for landscape services, home
construction, and recreational industries, among others.
    TPI requests that all transporters of turfgrass sod be eligible for
the HOS exception for agricultural commodities provided in 49 CFR
395.1(k)(1). TPI asserts that sod producing members are concerned that
sod is not included in the definition of an agricultural commodity in
49 CFR 395.2. TPI believes that the failure to define sod as an
agricultural commodity is inconsistent with other Federal and State
regulations and creates an unnecessary economic burden for sod farmers
when transporting their product to market.
    According to TPI's application, turfgrass sod is a perishable
agricultural commodity that is recognized by the U.S. Department of
Agriculture and, like many other agricultural commodities, is planted
and harvested annually. Sod is cultivated and managed with techniques
and equipment similar to those used for other crops and is subject to
the same impacts of weather, weed infestations, insect pests, and plant
disease factors that impact other agricultural crops. Similarly, once
harvested for sale it is also subject to perishing in transport.
Specifically, sod often loses its color, moisture, and vigor due to
transplant shock and can die if palleted too long. Sod's perishability
depends on many of the same factors that impact the transportation of
other agricultural commodities including temperature, desiccation,
oxygen and light deprivation, increased respiration, carbon starvation,
etc., all of which negatively impact the quality of turfgrass sod.
    TPI asserts that the lack of an HOS exemption granted to other
agricultural commodities by 49 CFR 395.1(k)(1) will impact sod haulers'
business heavily. Their inability to deliver their perishable product
to market in a timely manner will result in a decrease in the amount of
product they can ship and an increase in the amount of product that
either perishes in transport or is damaged in transport, resulting in
customers who refuse delivery or are otherwise not satisfied with sod
quality at delivery. If granted, TPI estimates that the exemption would
cover between 2,400 drivers (400 farm baseline) and 10,428 drivers
(1,738 farm maximum).

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

    TPI essentially argues that the exemption would achieve a level of
safety equivalent to that of others transporting agricultural
commodities within 150 air miles of the source of the agricultural
commodity. TPI is requesting that the Agency exercise its statutory
authority to extend to the transporters of turfgrass sod the same HOS
relief provided by Congress to transporters of specified agricultural
commodities. TPI states that it will work with natural grass sod
haulers to ensure they understand existing safety regulations regarding
the operation of commercial motor vehicles. TPI contends that nothing
about weight, stacking configuration, etc., makes natural grass sod any
less safe to haul than other agricultural commodities, as demonstrated
by the proven track record that natural grass sod farmers have had for
many years while hauling sod as an agricultural commodity.

    A copy of TPI's application for exemption is available for review
in the docket for this notice.

    Issued on: June 12, 2019.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2019-13016 Filed 6-18-19; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 75, Number 1 (Monday, January 4, 2010)]
[Notices]
[Pages 144-145]
[FR Doc No: E9-31148]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2009-0536; FRL-9100-2]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; Emission Guidelines and
Compliance Times for Municipal Solid Waste Landfills (Renewal); EPA ICR
No. 1893.05, OMB Control No. 2060-0430

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that an Information
Collection Request (ICR) has been forwarded to the Office of Management
and Budget (OMB) for review and approval. This is a request to renew an
existing approved collection. The ICR, which is abstracted below,
describes the nature of the information collection and its estimated
burden and cost.

DATES: Additional comments may be submitted on or before February 3,
2010.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OECA-
2009-0536, to (1) EPA online using http://www.regulations.gov (our
preferred method) or by mail to: EPA Docket Center, Environmental
Protection Agency, Mail Code: 28221T, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460, and (2) OMB by mail to: Office of Information and
Regulatory Affairs, Office of Management and Budget (OMB), Attention:
Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Hillary Ward, Office of Air Quality
Planning and Standards, MC E143-01, Environmental Protection Agency,
109 T.W. Alexander Drive, Research Triangle Park, NC 27711; telephone
number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On July 30, 2009 (74 FR 38004), EPA sought comments on this
ICR pursuant to 5 CFR 1320.8(d). EPA received no comments. Any
additional comments on this ICR should be submitted to EPA and OMB
within 30 days of this notice.
    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OAR-2009-0536, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the OECA Docket
Center, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington,
DC. The EPA/DC 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 Reading Room is<PHONE_NUMBER>, and the telephone number for the
OECA Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://www.regulations.gov to submit or view public comments, access the index
listing of the contents of the docket, and to access those documents in
the docket that are available electronically. Once in the system,
select ``docket search,'' then key in the docket ID number identified
above. Please note that EPA's policy is that public comments, whether
submitted electronically or in paper, will be made available for public
viewing at http://www.regulations.gov as EPA receives them and without
change, unless the comment contains copyrighted material, confidential
business information (CBI), or other information whose public
disclosure is restricted by statute. For further information about the
electronic docket, go to http://www.regulations.gov.
    Title: Emission Guidelines and Compliance Times for Municipal Solid
Waste Landfills (Renewal).
    ICR Status: This ICR is scheduled to expire on January 31, 2010.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
An Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information, unless it displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR part 9 and displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers in certain EPA regulations is
consolidated in 40 CFR part 9.
    Abstract: This ICR is a renewal of current data collection and
reporting requirements for Municipal Solid Waste Landfills subject to
40 CFR part 60, subpart Cc emission guidelines. The subpart Cc
guidelines are implemented through either State plans or the Federal
plan (40 CFR part 62, subpart GGG) that EPA developed for landfills
located in States and Indian country that did not

develop a State or Tribal plan. State plans were due to EPA by December
12, 1996 and the Federal plan was promulgated on November 8, 1999. The
data collection is a mandatory requirement (Clean Air Act section
114(a)(1)).
    The information generated by the monitoring, recordkeeping, and
reporting requirements described in this ICR is used by the Agency to
ensure that facilities affected by the emission guidelines continue to
operate the control equipment and achieve compliance with the
regulation. The emission guidelines require affected facilities to
maintain all records, including the submitted reports and notifications
for at least 5 years.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 15
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: Municipal Solid Waste Landfills.
    Estimated Number of Respondents: 559.
    Frequency of Response: Annual.
    Estimated Total Annual Hour Burden: 46,146.
    Estimated Total Annual Cost: $3,956,321, which includes labor costs
of $3,229,721 and operation and maintenance costs of $726,600.
    Changes in the Estimates: There is an increase of 33,690 hours in
the total estimated burden currently identified in the OMB Inventory of
Approved ICR Burdens. This increase reflects the recordkeeping and
reporting burden for entities under State plans and the Federal plan.
The original ICR included only the burden for municipal solid waste
landfills subject to the Federal plan for municipal solid waste
landfills. This ICR renewal adds the burden imposed by State plans to
the burden imposed by the Federal plan.

    Dated: December 24, 2009.
Richard T. Westlund,
Acting Director, Collection Strategies Division.
[FR Doc. E9-31148 Filed 12-31-09; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 109 (Tuesday, June 7, 2022)]
[Rules and Regulations]
[Pages 34577-34579]
[FR Doc No: 2022-12065]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2021-0188; FRL-9775-02-R4]

Air Plan Approval; Kentucky; Source Specific Changes for
Jefferson County

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving changes
to the Kentucky State Implementation Plan (SIP), submitted by the
Commonwealth of Kentucky, through the Energy and Environment Cabinet
(Cabinet), on March 4, 2020, and supplemented on January 28, 2022. The
changes were submitted on behalf of the Louisville Metro Air Pollution
Control District (District), which has jurisdiction over Jefferson
County, Kentucky, and make changes to a Reasonably Available Control
Technology (RACT) determination for a specific major source of nitrogen
oxides (NOX) and volatile organic compound (VOC) emissions.
EPA is approving these changes as they are consistent with the Clean
Air Act (CAA or Act).

DATES: This rule is effective July 7, 2022.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2021-0188. All documents in the docket
are listed on the www.regulations.gov website. Although listed in the
index, some information may not be publicly available, i.e.,
Confidential Business Information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy at the Air Regulatory Management Section, Air Planning and
Implementation Branch, Air and Radiation Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia
30303-8960. EPA requests that if at all possible, you contact the
person listed in the FOR FURTHER INFORMATION CONTACT section to
schedule your inspection. The Regional Office's official hours of
business are Monday through Friday 8:30 a.m. to 4:30 p.m., excluding
Federal holidays.

FOR FURTHER INFORMATION CONTACT: Sarah LaRocca, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air and
Radiation Division, Region 4, U.S. Environmental Protection Agency, 61
Forsyth Street SW, Atlanta, Georgia 30303-8960. The telephone number is
(404) 562-8994. Ms. LaRocca can also be reached via electronic mail at
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    EPA is approving changes to the Kentucky SIP that were received by
EPA on March 4, 2020, and supplemented on January 28, 2022. Approval of
this submission incorporates Board Order--Amendment 2, issued by the
Air Pollution Control Board of Jefferson County (Board) for American
Synthetic Rubber Company (ASRC), into the SIP. This amended Board Order
\1\ replaces in the SIP the existing Board Order issued by the Board
for ASRC.
---------------------------------------------------------------------------

    \1\ A Board Order issued by the Board is a regulatory instrument
which specifies air pollution control limits or requirements for a
specific source or company. See 66 FR 53665, 53671 (October 23,
2001) (Response 2I).
---------------------------------------------------------------------------

II. Analysis of State Submission

    Three counties in the Louisville area (Jefferson County in Kentucky
and Clark and Floyd Counties in Indiana) were designated as
nonattainment for ozone on March 3, 1978 (43 FR 8962). On November 6,
1991 (56 FR 56694), after the CAA Amendments of 1990 were enacted,
Jefferson County and portions of Bullitt and Oldham Counties in
Kentucky and the Indiana Counties of Clark and Floyd were designated as
the Louisville Moderate ozone nonattainment area (Louisville Area)
under section 107(d)(4)(A) as a result of monitored violations of the
1979 1-hour ozone national ambient air quality standards (NAAQS) during
1987-1989.\2\
---------------------------------------------------------------------------

    \2\ The Louisville Area was subsequently redesignated to
attainment for the 1979 1-hour ozone NAAQS. See 66 FR 53665 (October
23, 2001). More recently, the Louisville Area was designated as
Marginal nonattainment for the 2015 ozone NAAQS. See 83 FR 25776
(June 4, 2018).
---------------------------------------------------------------------------

    Section 182(b)(2) of the CAA requires states to adopt RACT for all
major stationary sources of VOC in Moderate and above ozone
nonattainment areas. Section 182(f) of the CAA requires that the same
provisions for major stationary sources of VOC shall also apply to
major stationary sources of NOX. Therefore, pursuant to
section 182(f), RACT is a requirement, with certain exceptions
described therein, for major sources of NOX in ozone
nonattainment areas where VOC RACT applies.
    To comply with the NOX RACT requirement, which was a
result of the Moderate nonattainment area designation for the 1-hour
ozone NAAQS, the District submitted Jefferson County Air Quality
Regulation 6.42, Reasonably Available Control Technology Requirements
for Major Volatile Organic Compound- and Nitrogen Oxides-Emitting
Facilities, to EPA approval.\3\ Regulation 6.42 requires the
establishment and implementation of RACT, including the determination
and demonstration of compliance with RACT, for certain emission units
located at a major stationary source of NOX or VOC emissions
and requires that each determination of RACT approved by the District
be submitted to EPA as a source-specific revision to the Kentucky SIP.
RACT is defined at paragraph 1.66 of District Regulation 1.02 as
meaning ``devices, systems, process modifications, or other apparatus
or techniques, including pollution prevention approaches, that are
reasonably available taking into account the necessity of imposing
those controls in order to attain and maintain a national ambient air
quality standard and the social, environmental, and economic impact of
those controls.''
---------------------------------------------------------------------------

    \3\ EPA incorporated Regulation 6.42 into the Jefferson County
portion of the Kentucky SIP on October 23, 2001. See 66 FR 53658.
---------------------------------------------------------------------------

    As discussed in EPA's June 22, 2001 (66 FR 33505), proposal to
redesignate the Louisville Area to attainment for the 1979 1-hour ozone
NAAQS, Regulation 6.42 has been implemented in part by means of Board
Orders adopted by the Air Pollution Control Board of Jefferson County.
Such Board Orders contain NOX RACT and VOC RACT plans, which
set forth RACT requirements for the source, including monitoring,
recordkeeping, and reporting requirements, as attachments.
    On August 1, 2019, ASRC submitted a proposed RACT plan to the
District for three new boilers, referred to as Boilers B5, B6, and B7,
that are planned to be constructed to replace the facility's existing
Boiler Nos. 1, 2, 3, and 4. The Board approved Board Order--

Amendment 1 on November 20, 2019. Board Order--Amendment 1 includes as
an attachment a revised RACT plan that addresses RACT for both
NOX and VOC emissions.\4\ On March 4, 2020, the District,
through the Cabinet, submitted a SIP revision to EPA to replace the
existing Board Order for ASRC with Board Order--Amendment 1. On
November 17, 2021, the Board approved Board Order--Amendment 2, which
includes an updated RACT plan.\5\ On January 28, 2022, the District,
through the Cabinet, submitted to EPA a supplement to the March 4,
2020, SIP revision to replace Board Order--Amendment 1 with Board
Order--Amendment 2.
---------------------------------------------------------------------------

    \4\ The existing SIP-approved Board Order does not include VOC
RACT requirements.
    \5\ Specifically, the RACT plan was updated to include revised
NOX monitoring requirements that are better suited to the
30-day rolling average NOX limit for the new boilers.
---------------------------------------------------------------------------

    In a notice of proposed rulemaking (NPRM) published on April 26,
2022, see 87 FR 24510, EPA proposed to approve changes to the Jefferson
County portion of the Kentucky SIP provided on March 4, 2020, and
supplemented on January 28, 2022. The April 26, 2022, NPRM provides
additional detail regarding the background and rationale for EPA's
action. Comments on the NPRM were due on or before May 26, 2022. No
comments were received on this action.

III. Incorporation by Reference

    In this document, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing the incorporation by reference of Board Order--
Amendment 2, including the attached VOC/NOX RACT Plan, for
ASRC, effective November 17, 2021, as discussed in Section II of this
preamble. Also in this document, EPA is finalizing the removal of the
Board Order for ASRC effective January 1, 2001, from the Kentucky SIP,
which is incorporated by reference in accordance with the requirements
of 1 CFR part 51. EPA has made, and will continue to make, the SIP
generally available at the EPA Region 4 Office (please contact the
person identified in the FOR FURTHER INFORMATION CONTACT section of
this preamble for more information) section of this preamble for more
information). Therefore, these materials have been approved by EPA for
inclusion in the SIP, have been incorporated by reference by EPA into
that plan, are fully federally enforceable under sections 110 and 113
of the CAA as of the effective date of the final rulemaking of EPA's
approval, and will be incorporated by reference in the next update to
the SIP compilation.\6\
---------------------------------------------------------------------------

    \6\ See 62 FR 27968 (May 22, 1997).
---------------------------------------------------------------------------

IV. Final Action

    EPA is approving the replacement of the existing Board Order in the
Kentucky SIP for ASRC with Board Order--Amendment 2, including the
attached VOC/NOX RACT Plan, for ASRC, effective November 17,
2021, because it achieves at least the same level of NOX
emission reductions as the previously SIP-approved Board Order and
meets the VOC RACT requirements of Regulation 6.42. ASRC's replacement
of two existing coal-fired boilers and two existing natural gas-fired
boilers with three new natural gas-fired boilers will achieve
NOX and VOC emission reductions at the facility, and there
are no potential air pollutant emission increases associated with this
proposed SIP revision. EPA is approving these changes because they are
consistent with SIP-approved Jefferson County Air Quality Regulation
6.42 and with the CAA.

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. This action merely
approves state law as meeting Federal requirements and does not impose
additional requirements beyond those imposed by state law. For that
reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by August 8, 2022. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of

such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. See section 307(b)(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Incorporation by reference, Nitrogen
oxides, Ozone, Reposting and recordkeeping requirements, Volatile
organic compounds.

    Dated: May 31, 2022.
Daniel Blackman,
Regional Administrator, Region 4.

    For the reasons stated in the preamble, the EPA amends 40 CFR part
52 as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart S--Kentucky

0
2. In Sec.  52.920(d), amend the table by:
0
a. Removing the entry for ``Board Order American Synthetic Rubber
Company''; and
0
b. Adding an entry at the end of the table for ``Board Order for the
American Synthetic Rubber Company--Amendment 2''.
    The addition reads as follows:

Sec.  52.920   Identification of plan.

* * * * *
    (d) * * *

                               EPA-Approved Kentucky Source-Specific Requirements
----------------------------------------------------------------------------------------------------------------
                                                       State
           Name of Source              Permit No.    effective      EPA approval date          Explanations
                                                       date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Board Order for the American                  N/A   11/17/2021   6/7, 2022, [Insert       Including the attached
 Synthetic Rubber Company--Amendment                              citation of              VOC/NOX RACT Plan.
 2.                                                               publication].
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2022-12065 Filed 6-6-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 41 (Thursday, March 1, 2018)]
[Notices]
[Pages 8883-8885]
[FR Doc No: 2018-04175]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-5925]

Susceptibility Test Interpretive Criteria Recognized and Listed
on the Susceptibility Test Interpretive Web Page; Reopening of a Public
Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of a public docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
reopening a docket for public comment on the susceptibility test
interpretive criteria for antibacterial and antifungal drugs provided
by FDA on its Susceptibility Test Interpretive Criteria web page
(Interpretive Criteria web page) established on December 13, 2017. On
the Interpretive Criteria web page, FDA recognizes, in whole or in
part, susceptibility test interpretive criteria standards established
by Standard Development Organizations (SDOs) and lists other
susceptibility test interpretive criteria identified by FDA outside of
the SDO process.

DATES: This notice is published in the Federal Register on March 1,
2018.

ADDRESSES: You may submit either electronic or written comments and
information as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-N-5925 for ``Susceptibility Test Interpretive Criteria
Recognized and Listed on the Susceptibility Test Interpretive web page;
Request for Comments.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments to the docket at any time.

FOR FURTHER INFORMATION CONTACT: Katherine Schumann, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6242, Silver Spring, MD 20993-0002, 301-
796-1182, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On December 13, 2017, FDA established the Interpretive Criteria web
page (https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm410971.htm) that contains a list of FDA-
recognized susceptibility test interpretive criteria standards,
established by an SDO that fulfills the requirements under section
511A(b)(2)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 360a-2(b)(2)(A)); identifies when FDA does not recognize, in
whole or in part, susceptibility test interpretive criteria established
by an SDO; and lists susceptibility test interpretive criteria
identified by FDA outside the SDO process. The susceptibility test
interpretive criteria standards recognized by FDA on the Interpretive
Criteria web page are deemed to be recognized as a standard under
section 514(c)(1) of the FD&C Act (21 U.S.C. 360d(c)(1)).
    At least every 6 months after the establishment of the Interpretive
Criteria web page, FDA will publish on the Interpretive Criteria web
page a notice recognizing new or updated susceptibility test
interpretive criteria standards, or parts of standards; withdrawing
recognition of susceptibility test interpretive criteria standards, or
parts of standards; and making any other necessary updates to the lists
published on the Interpretive Criteria web page. Once a year FDA will
compile the notices from that year and publish them in the Federal
Register and provide for public comment. If comments are received, FDA
will review those comments and make any updates to the recognized
standards or susceptibility test interpretive criteria as needed.

II. Recommendation of New or Updated Susceptibility Test Interpretive
Criteria for Listing by FDA

    This Federal Register notice is a request for comments by
interested third parties on FDA's initial susceptibility test
interpretive criteria recognition and listing determinations on the
Interpretive Criteria web page. FDA may consider information provided
by interested third parties as a basis for updating interpretive
criteria standards. This notice allows interested third parties the
opportunity to comment on FDA's recognition and listing determinations
before the annual compilation of notices of susceptibility test
interpretive criteria changes made that year.
    Interested third parties or drug sponsors may provide information
that FDA could use as a basis for listing new or for updating
susceptibility interpretive criteria. This information should be
submitted to Docket No. FDA-2017-N-5925. If comments are received, FDA
will review those comments and will make, as necessary, updates to the
recognized standards or susceptibility test interpretive criteria.
    If preferred, application holders may submit data supporting
changes to FDA's susceptibility test interpretive criteria recognition
or listing determinations through the application holder's annual
report under the new drug application. If submitting this data,
application holders are encouraged to identify in the cover letter of
the annual report that the enclosed submission includes data supporting
changes to FDA's susceptibility test interpretive criteria recognition
or listing determinations. FDA will review these annual report
submissions and

determine whether changes or updates to the currently recognized
susceptibility test interpretive criteria are appropriate. FDA will
then update the Interpretive Criteria web page to reflect these
changes, as needed.

    Dated: February 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04175 Filed 2-28-18; 8:45 am]
 BILLING CODE 4164-01-P