[Federal Register Volume 81, Number 26 (Tuesday, February 9, 2016)]
[Notices]
[Page 6848]
[FR Doc No: 2016-02504]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER16-861-000]

Iron Springs Solar, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Iron Springs Solar, LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is February 23, 2016.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the Web site that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: February 3, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-02504 Filed 2-8-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 74, Number 110 (Wednesday, June 10, 2009)]
[Notices]
[Pages 27562-27570]
[FR Doc No: E9-13516]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

Susan Harwood Training Grant Program, FY 2009

AGENCY: Occupational Safety and Health Administration, Labor.

ACTION: Initial announcement of availability of funds and solicitation
for grant applications (SGA).

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    Funding Opportunity No.: SHTG-FY-09-02.
    Catalog of Federal Domestic Assistance No.: 17.502.
SUMMARY: The U.S. Department of Labor, Occupational Safety and Health
Administration (OSHA) awards funds to nonprofit organizations to
provide training and educational programs for employers and workers
about safety and health topics selected by OSHA. Nonprofit
organizations, including qualifying labor unions and community-based
and faith-based organizations that are not an agency of a State or
local government are eligible to apply. Additionally, State or local
government-supported institutions of higher education are eligible to
apply in accordance with 29 CFR part 95. This notice announces grant
availability for Susan Harwood Training Program grants. All information
and forms needed to apply for this funding opportunity are published as
part of this SGA or are available on the Grants.gov site.

DATES: Grant applications must be received electronically by the
Grants.gov system no later than 4:30 p.m., E.T., on Friday, July 24,
2009, the application deadline date.

ADDRESSES: Applications for grants submitted under this competition
must be submitted electronically using the government-wide Grants.gov
Apply site at: http://www.grants.gov. If applying online poses a
hardship to any applicant, the OSHA Directorate of Training and
Education will provide assistance to ensure that applications are
submitted online by the closing date. Applicants must contact the OSHA
Directorate of Training and Education office listed on the announcement
at least one week prior to the application deadline date (or no later
than 4:30 p.m., E.T., on July 17, 2009) to speak to a representative
who can provide assistance to ensure that applications are submitted
online by the closing date. Requests for extensions to this deadline
will not be granted. Further information regarding submitting your
grant application electronically is listed in Section IV, Item 3,
Submission Date, Times, and Addresses.

FOR FURTHER INFORMATION CONTACT: Any questions regarding this SGA
should be directed to Cynthia Bencheck, Program Analyst, e-mail
address<EMAIL_ADDRESS>tel:<PHONE_NUMBER> (note that this is
not a toll-free number), or Jim Barnes, Director, Office of Training
and Educational Programs, e-mail address<EMAIL_ADDRESS>tel: 847-
297-4810 (note that this is not a toll-free number). To obtain further
information on the Susan Harwood Training Grant Program of the U.S.
Department of Labor, visit the OSHA Web site at: http://www.osha.gov.

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

Overview of the Susan Harwood Training Grant Program

    The Susan Harwood Training Grant Program provides funds for
programs to train workers and employers to recognize, avoid, and
prevent safety and health hazards in their workplaces. The program
emphasizes four areas:
     Educating workers and employers in small businesses. For
purposes of this grant program, a small business is one with 250 or
fewer employees.
     Training workers and employers about new OSHA standards.
     Training at-risk worker and employer populations.
     Training workers and employers about high risk activities
or hazards identified by OSHA through the Department of Labor's
Strategic Plan, or as part of an OSHA special emphasis program.

Grant Category Being Announced

    Under this solicitation for grant applications, OSHA will accept
applications for the Targeted Topic training grant category. The
emphasis for applications submitted for the Target Topic training grant
category should be on conducting training for multiple employers and
their workers addressing safety and health hazards associated with one
of the selected training topic areas listed below.

Topics for the Targeted Topic Training Category

    Organizations funded for Targeted Topic training category grants
are expected to develop and provide occupational safety and health
training and/or educational programs addressing one of the topics
selected by OSHA; recruit workers and employers for the training; and
conduct and evaluate the training. Grantees are also expected to
conduct follow-up evaluations with individuals trained by their program
to determine what, if any, changes were made to reduce hazards in their
workplaces as a result of the training. If your organization plans to
train workers or employers in any of the 26 states operating OSHA-
approved State Plans, State OSHA requirements for that state must be
included in the training.
    Twenty-four different training topics were selected for this grant
announcement. OSHA may award grants for some or all of the listed
Targeted Topic training topics.
    Applicants are required to focus their grant application proposal
to address only one of the training topics from the list of 24 training
topics OSHA has selected for this grant solicitation. Applicants
wishing to address more than one of the announced grant training topics
must submit a separate grant application for each topic. Each
application must propose a plan for developing and conducting training
programs addressing the recognition and prevention of safety and health
hazards that focuses on one of the training topics listed below.
Training Topics That Address Construction Industry Hazards
    Programs that train workers and employers in the recognition and
prevention of safety and health hazards addressing one of the following
training topic areas.
1. Crane Safety, including but not limited to the following subtopics:
safety hazards relating to Derricks, Overhead Hazards, and Tower Cranes
2. Fall Protection, including but not limited to the following
subtopics:

Ladders, Roofs, Scaffolds, and Steel Erection
3. Construction Focus Four hazards, integrating all four elements in
training programs: Falls, Electrocution, Caught-in and Struck-by
4. Health Hazards in Construction, including but not limited to the
following subtopics: Hexavalent Chromium, Lead, Noise, Silica with a
special emphasis on training non-English speaking/limited-English-
proficient workers
5. Safety Hazards related to Mechanized, Over-the-Road and Heavy
Construction Equipment, including but not limited to the following
subtopic: Compactor Rollovers
6. Work Zone Safety
Training Topics That Address General Industry Hazards
    Programs that train workers and employers in the recognition and
prevention of safety and health hazards addressing one of the following
training topic areas.
7. Combustible Dust, including but not limited to the following
subtopics: Controlling Ignition Sources, Controlling Dust
Accumulations, Grain Handling Operations
8. Emergency Preparedness and Response, including but not limited to
the following subtopics: Pandemic Flu and Continuity of Operations
9. Falls in General Industry
10. Materials Handling, including but not limited to the following
subtopics: Cranes, Hazardous Materials, and Slings
11. Health Hazards in General Industry, including but not limited to
the following subtopics: Isocyanates, and Metal Working Fluids
12. Landscaping and Tree Service Safety, including but not limited to
the following subtopic: Hearing Conservation with a special emphasis on
training non-English speaking/limited-English-proficient workers
13. Night time Sanitation, Maintenance and Cleanup Crews working the
Third Shift in Food Processing Industries such as red meat, poultry,
and fish, including but not limited to the following subtopics:
Lockout/Tagout, Confined Spaces, Carbon Monoxide Hazards
14. Powered Industrial Trucks
15. Process Safety Management, including but not limited to the
following subtopics: Chemical Plants, Ethanol Plants, Refineries, and
Anhydrous Ammonia
16. Safety and Health Management Systems for Small and Medium-Sized
Businesses
Training Topics That Address Other Safety and Health Topic Areas
    Programs that train workers and employers in the recognition and
prevention of safety and health hazards addressing one of the following
training topic areas.
17. Alternative Energy Industry Hazards, including but not limited to
the following subtopics: Biofuels, Elevated Tower Work, Hydrogen
Production and Distribution, Solar Farming, and Wind Farming
18. Electrical Safety, including but not limited to the following
subtopics: Arc Flash and Personal Protective Equipment (PPE) for Arc
Flash, Proper Grounding Techniques, and Electrical Transmission and
Distribution
19. Ergonomics, including but not limited to the following subtopics:
Nursing Homes, Poultry Processing, Retail Grocery Stores, Masonry
Construction, and Solid Waste Removal
20. Heat Stress Exposure, including but not limited to migrant workers
21. Maritime, including but not limited to the following subtopics:
Maritime Standards, Longshoring, Marine Terminals, Shipbreaking,
Shipyard Safety Hazards including Electrical Hazards and Arc Flash,
Ergonomics, Personal Protective Equipment (PPE) including Flotation
Devices, and Emergency Procedures
22. Native American Tribal Safety and Health Issues, including but not
limited to the following subtopics: Confined Space, Bloodborne
Pathogens, Construction Safety, Health and Safety in Waste Water
Treatment Facilities, and in the Health Care Industry
23. Oil and Gas, including but not limited to the following subtopics:
Exploration, Production, and Well Development
24. OSHA Recordkeeping Process. Develop materials and conduct training
to train workers and employers in the recognition and compliance
requirements of the Recordkeeping system to accurately record cases and
respond to injury or illness information appropriately in the following
sections contained under Part 1904: General Recording Criteria
(1904.7), Covered Employees (1904.31), Employee Involvement (1904.35),
and Prohibition Against Discrimination (1904.36)

II. Award Information

    Targeted Topic training grants will be awarded for a 24-month
project performance period. The 24-month project period for these
grants begins no later than September 30, 2009. There is approximately
$6.9 million available for the Targeted Topic grant category in 2009.
The average Federal award will be approximately $250,000. Historically,
the Harwood Grant Program has been reauthorized from year to year. The
Department of Labor expects, but cannot guarantee, that this will be so
in the future. If Congress appropriates the necessary funds, the
Department of Labor will award second year grants to eligible
applicants.

III. Eligibility Information

1. Eligible Applicants

    Nonprofit organizations, including qualifying labor unions and
community-based and faith-based organizations that are not an agency of
a State or local government are eligible to apply. Additionally, State
or local government-supported institutions of higher education are
eligible to apply in accordance with 29 CFR part 95. Eligible
organizations can apply independently for funding or in partnership
with other eligible organizations, but in such a case, the lead
organization must be identified. Sub-grants are not authorized.
Subcontracts, if any, must be awarded in accordance with 29 CFR 95.40-
48, including OMB circulars requiring full and open competition for
procurement transactions, to the maximum extent practicable.
    A 501(c)(4) nonprofit organization, as described in 26 U.S.C.
501(c)(4), that engages in lobbying activities will not be eligible for
the receipt of Federal funds constituting an award, grant or loan. See
1 U.S.C. 1611.
    Applicants other than State or local government supported
institutions of higher education will be required to submit evidence of
nonprofit status from the Internal Revenue Service (IRS).

2. Cost Sharing or Matching

    Applicants are not required to contribute non-Federal resources.

3. Other Eligibility Requirements

    Legal rules pertaining to inherently religious activities by
organizations that receive Federal financial assistance.
    The U. S. Government is generally prohibited from providing
``direct''

financial assistance for inherently religious activities.\1\
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    \1\ In this context, the term direct financial assistance means
financial assistance that is provided directly by a government
entity or an intermediate organization, as opposed to financial
assistance that an organization receives as the result of the
genuine and independent private choice of a beneficiary. In other
contexts, the term ``direct'' financial assistance may be used to
refer to financial assistance that an organization receives directly
from the Federal government (also known as ``discretionary''
assistance), as opposed to assistance that it receives from a State
or Local government (also known as ``indirect'' or ``block'' grant
assistance). The term ``direct'' has the former meaning throughout
this solicitation for grant applications (SGA).
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    The Grantee may be a faith-based organization or work with and
partner with religious institutions; however, ``direct'' federal
assistance provided under grants with the U.S. Department of Labor may
not be used for religious instruction, worship, prayer, proselytizing
or other inherently religious practices. 29 CFR Part 2, Subpart D
governs the treatment in Department of Labor government programs of
religious organizations and religious activities; the Grantee and sub-
contractors are expected to be aware of and observe the regulations in
this subpart.

IV. Application and Submission Information

1. Application Package

    All information and forms needed to apply for this funding
opportunity are published as part of this SGA or are available on the
Grants.gov site. For informational purposes, the complete Federal
Register notice is also posted on the OSHA Susan Harwood Training Grant
Program Web site at: http://www.osha.gov/dcsp/ote/sharwood.html.

2. Content and Form of Application Submission

    Each grant application must address only one of the 24 announced
training topics. Organizations interested in applying for grants for
more than one of the announced grant training topics must submit a
separate application for each grant training topic.
A. Required Contents
    A complete application will contain the following mandatory forms,
mandatory document attachments and optional attachments.
    (1) Application for Federal Assistance form (SF 424). The
individual signing the SF 424 form on behalf of the applicant must be
authorized to bind the applicant.
    Your organization is required to have a Data Universal Number
System (DUNS) number from Dun and Bradstreet to complete this form.
Information about ``Obtaining a DUNS Number--A Guide for Federal Grant
and Cooperative Agreement Applicants'' is available at: http://www.whitehouse.gov/omb/grants/duns_num_guide. pdf.
    (2) Survey on Ensuring Equal Opportunity for Applicants (Faith-
Based EEO Survey) form OMB No. 1890-0014.
    (3) Program Summary (described further in subsection B below). The
program summary is a short one-to-two page single-sided abstract that
succinctly summarizes the proposed project and provides information
about the applicant organization.
    (4) Budget Information form (SF 424A).
    (5) Detailed Project Budget Backup. The detailed budget backup will
provide a detailed breakout of the costs that are listed in Section B
of the SF 424A Budget Information form. If applicable, provide a copy
of approved indirect cost rate agreement and statement of program
income. Indirect costs may only be requested if your organization
already has a current approved indirect cost rate agreement.
    (6) A description of any voluntary non-federal resource
contribution to be provided by the applicant, including source of funds
and estimated amount.
    (7) Technical Proposal program narrative (described further in
subsection B below), not to exceed 30 single-sided pages, double-
spaced, 12-point font, containing: Problem Statement/Need for Funds;
Administrative and Program Capability; and Work Plan.
    (8) Assurances form (SF 424B).
    (9) Combined Assurances form (ED 80-0013).
    (10) Organizational Chart.
    (11) Evidence of Non-Profit status from the Internal Revenue
Service (IRS), if applicable. (Does not apply to State and local
government-supported institutions of higher education.)
    (12) Accounting System Certification, if applicable. Organizations
that receive less than $1 million annually in Federal grants must
attach a certification signed by your certifying official stating that
your organization has a functioning accounting system that meets the
criteria below. Your organization may also designate a qualified entity
(include the name and address in the documentation) to maintain a
functioning accounting system that meets the criteria below. The
certification should attest that your organization's accounting system
provides for the following:
    (a) Accurate, current and complete disclosure of the financial
results of each Federally sponsored project.
    (b) Records that identify adequately the source and application of
funds for Federally sponsored activities.
    (c) Effective control over and accountability for all funds,
property and other assets.
    (d) Comparison of outlays with budget amounts.
    (e) Written procedures to minimize the time elapsing between the
transfer of funds.
    (f) Written procedures for determining the reasonableness,
allocability and allowability of costs.
    (g) Accounting records, including cost accounting records that are
supported by source documentation.
    (13) Any attachments such as resumes of key personnel or position
descriptions, exhibits, information on prior government grants, and
signed letters of commitment to the project. Please limit the number of
attachments to essential documents only.
    To be considered responsive to this solicitation, the application
must consist of the above mentioned separate parts. Major sections and
sub-sections of the application should be divided and clearly
identified, and all pages shall be numbered. Standard forms,
attachments, exhibits and the Program Summary abstract are not counted
toward the page limit.
    The forms listed above are available through the www.Grants.gov
site and must be submitted electronically as a part of your grant
application. In the Grants.gov system, there is a window containing a
menu of ``Mandatory Documents'' which must be completed and submitted
online within the system. For all other attachments such as the Program
Summary, Detailed Budget Backup, Technical Proposal, etc., please scan
these documents into a single Adobe Acrobat file and attach the
document in the area for attachments.
B. Budget Information
    Applicants must include the following required grant project budget
information.
    (1) Budget Information form (SF 424A).
    (2) A Detailed Project Budget that clearly details the costs of
performing all of the requirements presented in this solicitation. The
detailed budget will break out the costs that are listed in Section B
of the SF 424A Budget Information form. Applicants are asked to plan
for a funding level based on funds needed to perform work plan and
administrative activities for the grant project performance period.

    Applicants are reminded to budget for compliance with the
administrative requirements set forth. (Copies of all regulations that
are referenced in this solicitation for grant applications (SGA) are
available on-line at no cost at: http://www.osha.gov/dcsp/ote/sharwood.html.) This includes the costs of performing activities such
as travel for two staff members, one program and one financial, to the
Washington, DC, area to attend a new grantee orientation meeting;
financial audit, if required; project closeout; document preparation
(e.g., quarterly progress reports, project documents); and ensuring
compliance with procurement and property standards.
    The Detailed Project Budget should break out administrative costs
separately from programmatic costs for both federal and non-federal
funds. Administrative costs include indirect costs from the costs pool
and the cost of activities, materials, meeting close-out requirements
as described in Section VI, and personnel (e.g., administrative
assistants) who support the management and administration of the
project but do not provide direct services to project beneficiaries.
Indirect cost charges, which are considered administrative costs, must
be supported with a copy of a current approved Indirect Cost Rate
Agreement form. Administrative costs cannot exceed 25% of the total
grant budget. The project budget should clearly demonstrate that the
total amount and distribution of funds are sufficient to cover the cost
of all major project activities identified by the applicant in its
proposal, and must comply with Federal cost principles (which can be
found in the applicable OMB Circulars).
    (3) A description of any voluntary non-federal resource
contribution to be provided by the applicant, including source of funds
and estimated amount.
C. Program Summary and Technical Proposal
    The Program Summary and the Technical Proposal will contain the
narrative segments of the application. The Program Summary abstract is
not to exceed two single-sided, 12-point font, typed pages. The
Technical Proposal program narrative section is not to exceed 30
single-sided (8\1/2\'' x 11'' or A4), double-spaced, 12-point font,
typed pages, consisting of the Problem Statement/Need for Funds,
Administrative and Program Capability, and Work Plan. Reviewers will
only consider Technical Proposal information up to the 30-page limit.
The Technical Proposal must demonstrate the capability to successfully
administer the grant and to meet the objectives of this solicitation.
The Technical Proposal will be rated in accordance with the selection
criteria specified in Section V.
    The Program Summary and Technical Proposal must include the
following sections.
    (1) Program Summary. An abstract of the application, not to exceed
two single-sided pages, that must include the following information.
     Applicant organization's full legal name.
     Project Director's name, title, street address for
overnight delivery service, and mailing address if it is different from
the street address, telephone and fax numbers, and e-mail address. The
Project Director is the person who will be responsible for the day-to-
day operation and administration of the program. The Project Director's
name should also be the same name you list on the Application for
Federal Assistance form (SF-424) in section f. Name and contact
information of person to be contacted on matters involving this
application.
     Authorized Representative/Certifying Representative's
name, title, street address for overnight delivery service, and mailing
address if it is different from the street address, telephone and fax
numbers, and e-mail address. The Authorized Representative/Certifying
Representative is the official in your organization who is authorized
to enter into grant agreements. The Authorized Representative/
Certifying Representative's name should also be same name you list on
the Application for Federal Assistance form (SF-424) in section 21 for
Authorized Representative.
     If someone other than the Authorized Representative/
Certifying Representative described above will be authorized by your
organization to submit and sign off on quarterly financial reports (SF
269 forms) for OSHA, provide their name, title, street address for
overnight delivery service, and mailing address if it is different from
the street address, telephone and fax numbers, and e-mail address.
     Funding Amount. List the amount of Federal funding you are
requesting to perform work plan and administrative activities for the
grant project performance period. If your organization is contributing
non-Federal resources, also list the amount of non-Federal resources
and the source of those funds.
     Grant Topic. List the one grant training topic and
industry your organization has selected to target in its application.
     Summary of the Proposed Project. Write a brief program
summary of your proposed grant project.
     Applicant Background. Describe your applicant
organization, including its mission, identify the type of non-profit
organization it is, and provide a description of your membership, if
any. Your description should indicate how many full-time and part-time
employees your organization employs.
    (2) The Technical Proposal program narrative segment, which is not
to exceed 30 single-sided, double-spaced, 12-point font pages in
length, must address each section listed below.
     Problem Statement/Need for Funds. Describe the hazards
that will be addressed in your program, the target population(s) that
will benefit from your training and educational program, and the
barriers that have prevented this population from receiving adequate
training. When you discuss target populations, include geographic
location(s) to be served, and the number of workers and employers to be
reached.
     Administrative and Program Capability. Briefly describe
your organization's functions and activities. Relate this description
of functions to your organizational chart that you will include in the
application. If your organization is conducting, or has conducted
within the last five years, any other government (Federal, State, or
local) grant programs, the application must include an attachment
(which will not count towards the page limit) providing information
regarding previous grants including a) the organization for which the
work was done, and b) the dollar value of the grant. If your
organization has not had previous grant experience, you may partner
with an organization that has grant experience to manage the grant. If
you use this approach, the management organization must be identified
and its grant program experience discussed.
     Program Experience. Describe your organization's
experience conducting the type of program that you are proposing.
Include program specifics such as program titles, numbers trained and
duration of training. Experience includes safety and health experience,
training experience with adults, and programs operated specifically for
the selected target population(s). Nonprofit organizations, including
community-based and faith-based organizations, that do not have prior
experience in safety and health may partner with an established safety
and health organization to acquire safety and health expertise.
     Staff Experience. Describe the qualifications of the
professional staff

you will assign to the program. Include resumes of staff already on
board. If some positions are vacant, include position descriptions/
minimum hiring qualifications instead of resumes. Qualified staff is
generally defined as persons with safety and health experience and a)
training experience with adults or b) experience working with the
target population.
     Work Plan. Develop a 24-month work plan that is broken out
by calendar year quarters. An outline of specific items required in
your work plan follows.
     Each educational institution that receives Federal funds
for a fiscal year shall hold an educational program on the United
States Constitution on September 17 of such year for the students
served by the educational institution. Per Section 111 of Division J of
Public Law 108-447, the ``Consolidated Appropriations Act, 2005,''
December 8, 2004; 118 Stat. 2809, 3344-45, requires ``educational
institutions'' that receive Federal funds to hold an educational
program on the United States Constitution on September 17
(``Constitution Day and Citizenship Day'') of each year. The Office of
Personnel Management has placed relevant materials on its Web site at
the following address: http://opm.gov/constitution_initiative. Also,
the U.S. Department of Education's Federal Register Notice of the
Implementation of Constitution Day and Citizenship Day on September 17
of Each Year, published on May 24, 2005, can be found at: http://edocket.access.gpo.gov/2005/05-10355.htm. Please note that this site
primarily addresses educational institutions that receive funds from
the U.S. Department of Education. However, it also discusses other
materials that may be helpful to your organization.
     Work Plan Overview. Describe your plan for grant
activities and the anticipated outcomes. The overall plan will describe
such things as the development of training materials or the plan to use
existing training materials, the training content, recruiting of
trainees, where or how training will take place, and the anticipated
benefits to workers and employers receiving the training.
     Work Plan Activities. Break your overall plan down into
activities or tasks. For each activity, explain what will be done, who
will do it, when it will be done, and the results of the activity. When
you discuss training, include the subjects to be taught, the length of
the training sessions, and training location (classroom, worksites).
Describe how you will recruit trainees for the training. If your
organization is an educational institution, also describe the
educational activities your organization will conduct on Constitution
Day, September 17.
     Work Plan Quarterly Projections. For training and other
quantifiable activities, estimate how many (e.g., number of advisory
committee meetings, classes to be conducted, workers and employers to
be trained, etc.) you will accomplish each quarter of the grant (grant
quarters match calendar quarters, i.e., January to March, April to
June) and provide the training number totals for the grant.
Substantiate the methodology used to develop your projections. Grantees
are accountable for accomplishing the activities listed in their work
plans and meeting quarterly projections. Quarterly projections are used
to measure your actual performance against your plans. If you plan to
conduct a train-the-trainer program, estimate the number of individuals
you expect to be trained during the grant period by those who received
the train-the-trainer training. These second tier training numbers
should only be included if your organization is planning to formally
follow up with the trainers to obtain this data during the grant
project performance period.
     Materials. Describe each training material you will
produce under the grant, if not treated as a separate activity under
Activities above. Provide a timetable for developing and producing the
material. OSHA must review and approve training materials for technical
accuracy and suitability of content before the materials may be used in
your grant program. Therefore, your timetable must include provisions
for an OSHA review of draft and camera-ready products. Acceptable
formats for training materials include Microsoft Office 2003 or 2007
and Adobe Reader version 9.0, 8.1.3 and 8.1.2. Any previously developed
training materials you are proposing to utilize in your grant training
must also go through an OSHA review before being used.
     Evaluations. There are three types of evaluations that
should be conducted. First, describe plans to evaluate the training
sessions. Second, describe your plans to evaluate your progress in
accomplishing the grant work activities listed in your application.
This includes comparing planned vs. actual accomplishments. Discuss who
is responsible for taking corrective action if plans are not being met.
Third, describe your plans to assess the effectiveness of the training
your organization is conducting. This will involve following-up, by
survey or on-site review, if feasible, with individuals who attended
the training to find out what changes were made to abate hazards in
their workplaces. Include timetables for follow-up and for submitting a
summary of the assessment results to OSHA.
    (3) An organizational chart of the staff that will be working on
this grant and their location within the applicant organization.
    Attachments: Summaries of other relevant organizational
experiences; information on prior government grants;
r[eacute]sum[eacute]s of key personnel and/or position descriptions;
and signed letters of commitment to the project. Please limit the
number of attachments to essential documents only.
    Acceptable formats for document attachments submitted as a part of
a Grants.gov grant application include Microsoft Office 2003 or 2007
and Adobe Reader version 9.0, 8.1.3 and 8.1.2.

3. Submission Date, Times, and Addresses

    Date: The deadline date for receipt of applications is Friday, July
24, 2009. Applications must be received by 4:30 p.m., E.T., on the
closing date at:  http://www.grants.gov. Any application received after
the deadline will not be accepted.
    Electronic Submission of Applications: Applications for Susan
Harwood grants under this competition must be submitted electronically
using the government-wide Grants.gov Apply site at: http://www.grants.gov. Through this site you will be able to download a copy
of the application package, complete it offline, and then upload and
submit your full application. Acceptable formats for document
attachments submitted as a part of a Grants.gov grant application
include Microsoft Office 2003 or 2007 and Adobe Reader version 9.0,
8.1.3 and 8.1.2. In the Grants.gov system, there is a window containing
a menu of ``Mandatory Documents'' which must be completed and submitted
online within the system. For all other attachments such as the Program
Summary, Detailed Budget Backup, Technical Proposal, etc., please scan
these documents into a single Adobe Acrobat file and attach the
document in the area for attachments. Applications sent by mail or
other delivery services, e-mail, telegram, or facsimile (FAX) will not
be accepted. Applications that do not meet the conditions set forth in
this notice will not be honored.
    For applicants using Grants.gov for the first time, it is strongly
recommended that they immediately

initiate and complete the ``Get Registered'' steps to register with
Grants.gov at: http://www.grants.gov/applicants/get_registered.jsp.
These steps will probably take multiple days to complete, which should
be factored into an applicant's plans for electronic application
submission in order to avoid unexpected delays that could result in the
rejection of the application.
    If your organization is already registered with Grants.gov and
there have been any changes to your organization users, such as the E-
Business Point of Contact or Authorized Organization Representatives,
please be sure that the necessary updates are made with Grants.gov to
prevent delay in submission of the electronic application. Please note
that registered organizations must also renew their Central Contractor
Registration (CCR) registration once a year. This process takes five
days to complete, so it should be factored into an applicant's plans
for electronic application submission in order to avoid unexpected
delays that could result in the rejection of the application.
    If you have questions regarding the process for updating your
organization users or submitting your application through Grants.gov,
or are experiencing problems with electronic submissions, you may
contact the Grants Program Management Office via one of the methods
below:
     E-mail at<EMAIL_ADDRESS>     Telephone the Grants.gov Contact Center Phone: 1-800-518-
4726. The Contact Center hours of operation are Monday-Friday, 7 a.m.
to 9 p.m., Eastern Time; closed on Federal holidays.
     When contacting the Grants Program Management Office, the
following information will help expedite your inquiry.
    [cir] Funding Opportunity Number (FON).
    [cir] Name of Agency You Are Applying To.
    [cir] Specific Area of Concern.
    If applying online poses a hardship to any applicant, the OSHA
Directorate of Training and Education will provide assistance to ensure
that applications are submitted online by the closing date. Applicants
must contact the OSHA Directorate of Training and Education office
listed on the announcement at least one week prior to the application
deadline date (or not later than 4:30 p.m., E.T., on July 17, 2009) to
speak to a representative who can provide assistance to ensure that
applications are submitted online by the closing date. Requests for
extensions to this application deadline will not be granted.

4. Intergovernmental Review

    The Harwood Training Grant Program is not subject to Executive
Order 12372 Intergovernmental Review of Federal Programs.

5. Funding Restrictions

    Grant funds may be spent on the following.
    (a) Conducting training.
    (b) Conducting other activities that reach and inform workers and
employers about workplace occupational safety and health hazards and
hazard abatement.
    (c) Conducting outreach and recruiting activities to increase the
number of workers and employers participating in the program.
    (d) Developing and/or purchasing training materials for use in
training.
    Grant funds may not be used for the following activities under the
terms of the grant program.
    (a) Any activity that is inconsistent with the goals and objectives
of the Occupational Safety and Health Act of 1970.
    (b) Training individuals not covered by the Occupational Safety and
Health Act.
    (c) Training workers or employers from workplaces not covered by
the Occupational Safety and Health Act. Examples include: State and
local government employees in non-State Plan States, and employees
referenced in section 4 (b)(1) of the Act.
    (d) Training on topics that do not cover the recognition,
avoidance, and prevention of unsafe or unhealthy working conditions.
Examples of unallowable topics include: workers' compensation, first
aid, and publication of materials prejudicial to labor or management.
    (e) Assisting workers in arbitration cases or other actions against
employers, or assisting employers and workers in the prosecution of
claims against Federal, State or local governments.
    (f) Duplicating services offered by OSHA, a State under an OSHA-
approved State Plan, or consultation programs provided by State
designated agencies under section 21(d) of the Occupational Safety and
Health Act.
    Grant applicants cannot propose to conduct 10-hour and 30-hour OSHA
Construction Outreach Program courses or 10-hour and 30-hour OSHA
General Industry Outreach courses as a part of their grant activities.
Applicants also cannot propose to conduct the courses presented by the
OSHA Training Institute or its OSHA Training Institute Education
Centers.
    (g) Generating membership in the grantee's organization. This
includes activities to acquaint nonmembers with the benefits of
membership, inclusion of membership appeals in materials produced with
grant funds, and membership drives.
    (h) The cost of lost-time wages paid by you or other organizations
to students while attending grant-funded training.
    (i) Administrative costs cannot exceed 25% of the total grant
budget.
    While the activities described above may be part of an
organization's regular programs, the costs of these activities cannot
be paid for by grant funds, whether the funds are from non-Federal
matching resources or from the Federally funded portion of the grant.
    Determinations of allowable costs will be made in accordance with
the applicable Federal cost principles, e.g., Nonprofit Organizations--
2 CFR Part 230, formerly OMB Circular A-122; Educational Institutions--
2 CFR Part 220, formerly OMB Circular A-21. Disallowed costs are those
charges to a grant that the grantor agency or its representative
determines to not be allowed in accordance with the applicable Federal
cost principles or other conditions contained in the grant.
    No applicant at any time will be entitled to reimbursement of pre-
award costs.

V. Application Review Information

    Grant applications will be reviewed by technical panels comprised
of OSHA staff. The results of the grant reviews will be presented to
the Assistant Secretary of OSHA, who will make the selection of
organizations to be awarded grants. OSHA may award grants for some or
all of the listed topic areas. It is anticipated that the grant awards
will be announced no later than September 2009.

1. Evaluation Criteria

    The technical panels will review grant applications against the
criteria listed below on the basis of 100 maximum points. Targeted
Topic training grant category applications will be reviewed and rated
as follows.
A. Technical Approach, Program Design--50 points total
    Program Design
    (1) The proposed training and educational program must address the
recognition and prevention of safety and health hazards for one of the
Targeted Topic subject areas identified in Section I of this SGA. (1
point)
    (2) The proposal plans to train workers and/or employers, clearly

estimates the numbers to be trained, and clearly identifies the types
of workers and employers to be trained. The training will reach workers
and employers from multiple employers who are covered by the OSH Act.
Substantiate the methodology used to develop your projections. Grantees
are accountable for accomplishing the activities listed in their work
plans and meeting quarterly projections. (4 points)
    (3) If the proposal contains a train-the-trainer program, the
following information must be provided. (4 points)
     What ongoing support the grantee will provide to new
trainers;
     The number of individuals to be trained as trainers during
the grant period;
     The estimated number of courses to be conducted by the new
trainers during the grant period;
     The estimated number of students to be trained by these
new trainers during the grant period; and
     A description of how the grantee will obtain data via a
reporting system from the new trainers to document their classes and
student numbers.
    (4) There is a well-developed work plan, and activities and
training are adequately described. The planned activities and training
are appropriately tailored to the needs and levels of the workers and
employers to be trained. The target audience to be served through the
grant program is described. (20 points)
    (5) The training materials and training programs are tailored to
the training needs of one or more of the following target audiences;
and the need for training is established: small businesses; new
businesses; non-English speaking/limited English proficient, non-
literate and low literacy workers; youth; immigrant and minority
workers, and other hard-to-reach workers; and workers in high-hazard
industries and industries with high fatality rates.
    Grant proposals which include training programs and training
materials for hard-to-reach and non-English speaking/limited English
proficient workers will receive special consideration.
    Organizations proposing to develop Spanish-language training
materials must utilize the OSHA Dictionaries (English-to-Spanish and
Spanish-to-English) for terminology. The dictionaries are available on
the OSHA Web site at: http://www.osha.gov/dcsp/compliance_assistance/spanish_dictionaries.html. Organizations proposing to develop
materials in languages other than English will also be required to
provide an English version of the materials. (10 points)
    (6) There is a sound plan to recruit trainees for the program. (4
points)
    (7) If the proposal includes developing training materials for use
in the training program, there is a plan for OSHA to review the
training materials for technical accuracy and suitability of content
during development. If previously-developed training products will be
used for the Targeted Topic training program, applicants have a plan
for OSHA to review the materials before using the products in their
grant program. (1 point)
    (8) There are plans for three different types of evaluation. The
plans include evaluating your organization's progress in accomplishing
the grant work activities and accomplishments, evaluating your training
sessions, and evaluating the program's effectiveness and impact to
determine if the safety and health training and services provided
resulted in workplace change. This includes a description of the
evaluation plan to follow up with trainees to determine the impact the
program has had in abating hazards and reducing worker injuries. (5
points)
    (9) The application is complete, including forms, budget detail,
narrative and work plan, and required attachments. (1 point)
B. Budget--20 points total
    (1) The budgeted costs are reasonable. No more than 25% of the
total budget is for administration. (12 points)
    (2) The budget complies with federal cost principles (which can be
found in the applicable OMB Circulars) and with OSHA budget
requirements contained in the grant application instructions. (3
points)
    (3) The cost per trainee is less than $500 and the cost per
training hour is reasonable. (5 points)
C. Experience of Organization--15 points total
    (1) The organization applying for the grant demonstrates experience
with occupational safety and health. Applicants that do not have prior
experience in providing safety and health training to workers or
employers may partner with an established safety and health
organization to acquire safety and health expertise. (4 points)
    (2) The organization applying for the grant demonstrates experience
training adults in work-related subjects or in recruiting, training and
working with the target audience for this grant. (4 points)
    (3) The application organization demonstrates that the applicant
has strong financial management and internal control systems. (4
points)
    (4) The applicant organization has administered, or will work with
an organization that has administered, a number of different Federal
and/or State grants over the past five years. (3 points)
D. Experience and Qualification of Personnel--15 points total
    (1) The staff to be assigned to the project has experience in
occupational safety and health, the specific topic chosen, and in
training adults. (10 points)
    (2) Project staff has experience in recruiting, training, and
working with the target population your organization proposes to serve
under the grant. (5 points)
2. Review and Selection Process
    OSHA will screen all applications to determine whether all required
proposal elements are present and clearly identifiable. Incomplete
applications may be deemed non-responsive and may not be evaluated. A
technical panel will objectively rate each complete application against
the criteria described in this announcement. The panel recommendations
to the Assistant Secretary are advisory in nature. The Assistant
Secretary may establish a minimally acceptable rating range for the
purpose of selecting qualified applicants. The Assistant Secretary will
make a final selection determination based on what is most advantageous
to the government, considering factors such as panel findings,
geographic presence of the applicants, Agency priorities, the best
value to the government, cost, and other factors. The Assistant
Secretary's determination for award under this solicitation for grant
applications (SGA) is final.
3. Anticipated Announcement and Award Dates
    Announcement of these awards is expected to occur no later than
September 30, 2009.
    The grant agreements will be awarded by no later than September
2009.

VI. Award Administration Information

1. Award Process

    Organizations selected as grant recipients will be notified by a
representative of the Assistant Secretary. An applicant whose proposal
is not selected will be notified in writing.
    Notice that an organization has been selected as a grant recipient
does not constitute approval of the grant application as submitted.
Before the actual grant award, OSHA will enter

into negotiations concerning such items as program components, staffing
and funding levels, and administrative systems. If the negotiations do
not result in an acceptable submittal, the Assistant Secretary reserves
the right to terminate the negotiation and decline to fund the
proposal.

    Note: Except as specifically provided, OSHA's acceptance of a
proposal and an award of Federal funds to sponsor any program(s)
does not provide a waiver of any grant requirement or procedures.
For example, if an application identifies a specific sub-contractor
to provide services, the USDOL OSHA award does not provide the
justification or basis to sole-source the procurement, i.e., to
avoid competition.

2. Administrative and National Policy Requirements

    All grantees, including faith-based organizations, will be subject
to applicable federal laws and regulations (including provisions of
appropriations law) and the applicable Office of Management and Budget
(OMB) Circulars. The grant award(s) awarded under this SGA will be
subject to the following administrative standards and provisions, as
applicable to the particular grantee:
    29 CFR Part 2, Subpart D, new equal treatment regulations.
    29 CFR Parts 31, 32, 35 and 36 as applicable.
    29 CFR Part 93, new restrictions on lobbying.
    29 CFR Part 95, which covers grant requirements for nonprofit
organizations, including universities and hospitals. These are the
Department of Labor regulations implementing 2 CFR Part 215, formerly
OMB Circular A-110.
    29 CFR Part 98, government-wide debarment and suspension
(nonprocurement) and government-wide requirements for drug-free
workplace (grants).
    2 CFR Part 220, formerly OMB Circular A-21, which describes
allowable and unallowable costs for educational institutions.
    2 CFR Part 230, formerly OMB circular A-122, which describes
allowable and unallowable costs for other nonprofit organizations.
    OMB Circular A-133, 29 CFR parts 96 and 99, which provide
information about audit requirements.
    Certifications. All applicants are required to certify to a drug-
free workplace in accordance with 29 CFR part 98, to comply with the
New Restrictions on Lobbying published at 29 CFR part 93, to make a
certification regarding the debarment rules at 29 CFR part 98, and to
complete a special lobbying certification.
    Training Audience. Grant-funded training programs must serve
multiple employers and their workers. Grant-funded training programs
must serve individuals covered by the Occupational Safety and Health
Act of 1970. Grant-funded training and services cannot serve employees
of other federal agencies or OSHA employees. As a part of the grant
close-out process, grantees must self-certify that their grant-funded
programs and materials were not provided to ineligible audiences.
    Other. In keeping with the policies outlined in Executive Orders
13256, 12928, 13230, and 13021 as amended, the grantee is strongly
encouraged to provide subcontracting opportunities to Historically
Black Colleges and Universities, Hispanic Serving Institutions, and
Tribal Colleges and Universities.
    Freedom of Information Act (FOIA). Submission of the grant
application information is required in order for the applicant to be
considered for a grant award. Information submitted in the respondent's
application is not considered confidential. Awarded grant application
packages are releasable under the Freedom of Information Act. However,
information protected from disclosure under the Privacy Act will be
withheld.

3. Special Program Requirements

    OSHA review of training materials. OSHA will review all educational
materials produced by the grantee for technical accuracy and
suitability of content during development and before final publication.
OSHA will also review previously-developed training curricula and
purchased training materials for technical accuracy and suitability of
content before the materials are used. Grantees developing training
materials must follow all copyright laws and provide written
certification that their materials are free from copyright
infringements.
    When grant recipients produce training materials, they must provide
copies of completed final-product materials to OSHA before the end of
the grant period. OSHA has a lending program that circulates grant-
produced audiovisual materials. Audiovisual materials produced by the
grantee as a part of its grant program may be included in this lending
program. In addition, all materials produced by grantees must be
provided to OSHA in hard copy as well as in a digital format (CD Rom/
DVD) for possible publication on the Internet by OSHA. Two copies of
the materials must be provided to OSHA. Acceptable formats for training
materials include Microsoft Office 2003 or 2007 and Adobe Reader
version 9.0, 8.1.3 and 8.1.2.
    As stated in 29 CFR 95.36, the Department of Labor reserves a
royalty-free, nonexclusive and irrevocable right to reproduce, publish,
or otherwise use for federal purposes any work produced under a grant,
and to authorize others to do so. Applicants should note that grantees
must agree to provide the Department of Labor a paid-up, nonexclusive
and irrevocable license to reproduce, publish, or otherwise use for
federal purposes all products developed, or for which ownership was
purchased, under an award including, but not limited to, curricula,
training models, technical assistance products, and any related
materials, and to authorize the Department of Labor to do so. Such uses
include, but are not limited to, the right to modify and distribute
such products worldwide by any means, electronic or otherwise.
    Acknowledgment of USDOL Funding. In all circumstances, all approved
grant-funded materials developed by a grantee shall contain the
following disclaimer:
    This material was produced under grant number -------- from the
Occupational Safety and Health Administration, U.S. Department of
Labor. It does not necessarily reflect the views or policies of the
U.S. Department of Labor, nor does mention of trade names, commercial
products, or organizations imply endorsement by the U.S. Government.
    Public reference to grant: When issuing statements, press releases,
requests for proposals, bid solicitations, and other documents
describing projects or programs funded in whole or in part with federal
money, all grantees receiving federal funds must clearly state:
     The percentage of the total costs of the program or
project that will be financed with federal money;
     The dollar amount of federal financial assistance for the
project or program; and
     The percentage and dollar amount of the total costs of the
project or program that will be financed by non-governmental sources.
    Use of U.S. Department of Labor (USDOL) OSHA Logo: The USDOL-OSHA
logo may not be applied to any grant products developed with grant
funds.

4. Reporting

    Grantees are required by Departmental regulations to submit program
and financial reports each

calendar quarter. All reports are due no later than 30 days after the
end of the fiscal quarter. Program reports shall be submitted to the
appropriate OSHA Regional Office. Financial reports shall be submitted
via the DOL E-Grants system. The Grantee(s) shall submit financial
reports on a quarterly basis. The first reporting period shall end on
the last day of the fiscal quarter (December 31, March 31, June 30, or
September 30) during which the grant was signed. Financial reports are
due within 30 days of the end of the reporting period (i.e., by January
30, April 30, July 30, and October 30).
    The Grantee(s) shall use Standard Form (SF) 269, Financial Status
Report, to report the status of funds, at the project level, during the
grant period. A final SF269 shall be submitted no later than 90 days
following completion of the grant period. The SF269 reports will be
submitted electronically through the Department of Labor (DOL) E-Grants
system. It is expected that the Federal Financial Report (FFR) will
replace the SF269 by October 1, 2009, as mandated by the Office of
Management and Budget. When available, the FFR will replace the SF269
in DOL E-Grants. The quarterly and final reporting requirements will
not change.
    Technical Progress Reports: After signing the agreement, the
Grantee(s) shall submit technical progress reports to USDOL/OSHA
Regional Offices at the end of each fiscal quarter. Technical progress
reports provide both quantitative and qualitative information and a
narrative assessment of performance for the preceding three-month
period. OSHA Form 171 shall be used for reporting training numbers. In
addition, a narrative report shall be provided that details grant
activities conducted during the quarter, provides an assessment of how
the project is progressing in achieving its stated objectives, and
notes any problems or delays along with corrective actions proposed.
The first reporting period shall end on the last day of the fiscal
quarter (December 31, March 31, June 30, or September 30) during which
the grant was signed. Quarterly progress reports are due within 30 days
of the end of the report period (i.e., by January 30, April 30, July
30, and October 30.) Between reporting dates, the Grantees(s) shall
also immediately inform USDOL/OSHA of significant developments and/or
problems affecting the organization's ability to accomplish planned
grant activities.

    Authority:  The Occupational Safety and Health Act of 1970, (29
U.S.C. 670), Public Law 111-8, and the Omnibus Appropriations Act,
2009.

    Signed at Washington, DC, this 4th day of June, 2009.
Jordan Barab,
Acting Assistant Secretary of Labor for Occupational Safety and Health.

Application Document Checklist

Application for Federal Assistance (SF 424 form)
Budget Information (SF 424A form)
Assurances (SF 424B form)
Combined Assurances for (ED 80-0013 form)
Survey on Ensuring Equal Opportunity for Applicants (Faith-Based EEO
Survey), (OMB No. 1890-0014 form)
Attachments (Please attach in the following order):
Program Summary (not to exceed two single-sided pages)
Detailed Project Budget Backup
    If applicable: provide a copy of approved indirect cost rate
agreement, statement of program income, and a description of any
voluntary non-federal resource contribution to be provided by the
applicant, including source of funds and estimated amount.
    Technical Proposal, program narrative, not to exceed 30 single-
sided pages, double-spaced, 12-point font, containing: Problem
Statement/Need for Funds; Administrative and Program Capability; and
Work plan.
    Organizational Chart Evidence of Nonprofit status, (letter from the
IRS), if applicable Accounting System Certification, if applicable;
Other Attachments such as: Resumes of key personnel or position
descriptions, exhibits, information on prior government grants, and
signed letters of commitment to the project.

    Note:  In the Grants.gov system, there is a window containing a
menu of ``Mandatory Documents'' which must be completed and
submitted online within the system. For all other attachments such
as the Program Summary, Detailed Budget Backup, Technical Proposal,
etc., please scan these documents into a single Adobe Acrobat file
and attach the document in the area for attachments.

[FR Doc. E9-13516 Filed 6-9-09; 8:45 am]
BILLING CODE P


[Federal Register Volume 83, Number 106 (Friday, June 1, 2018)]
[Notices]
[Pages 25465-25466]
[FR Doc No: 2018-11784]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1043]

Waivers of the Single, Shared System Risk Evaluation and
Mitigation Strategy Requirement; Draft Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Waivers of
the Single, Shared System REMS Requirement.'' This guidance describes
how FDA intends to consider granting a waiver of the requirement in the
Federal Food, Drug, and Cosmetic Act (FD&C Act) that the applicant for
an abbreviated new drug application (ANDA) and its reference listed
drug (RLD) use a single, shared system (SSS) for a required risk
evaluation and mitigation strategy (REMS) with elements to assure safe
use (ETASU).

DATES: Submit either electronic or written comments on the draft
guidance by August 30, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time 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-2018-D-1043 for ``Waivers of the Single, Shared System Risk
Evaluation and Mitigation Strategy Requirement; Draft Guidance for
Industry; Availability.'' 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 on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Elaine Lippmann, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6238, Silver Spring, MD 20993, 301-796-

3600, [email protected]; or Stephen Ripley, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Waivers of the Single, Shared System REMS Requirement.''
This guidance describes how the Agency intends to consider granting a
waiver of the requirement in section 505-1(i) of the FD&C Act (21
U.S.C. 355-1(i)) that the applicant for an ANDA and its RLD use a SSS
for a required REMS with ETASU.
    Section 505-l(i)(l)(B) of the FD&C Act requires that a holder of an
ANDA under section 505(j) use a ``single, shared system'' with the RLD
for any ETASU, unless FDA waives this requirement. The statute permits
a waiver of the SSS requirement if FDA finds that (1) ``the burden of
creating a [SSS] outweighs the benefit of a single, system, taking into
consideration the impact on health care providers, patients, the
applicant for the [ANDA], and the holder of the reference drug
product,'' or (2) an aspect of the ETASU for the applicable listed drug
is claimed by an unexpired patent or trade secret and the ANDA
applicant certifies that it sought a license for use of the aspect, but
was unable to obtain one. If a waiver of the SSS requirement is
granted, the ANDA may use ``a different, comparable aspect of the
[ETASU],'' instead of participating in a SSS with the RLD.
    This guidance is intended to explain the factors FDA will consider
in evaluating a request for waiver of the SSS requirement and provide
recommendations to ANDA applicants regarding the submission and content
of waiver requests. The guidance also addresses FDA's interpretation of
what constitutes a different, comparable aspect of the ETASU as
described in section 505-1(i)(1)(B).
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Waivers of
the Single, Shared System REMS Requirement.'' It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. This guidance is not subject to
Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to collections of information that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). The
preparation and submission of waiver requests (as described in 21 CFR
314.90 for new drug application applicants and 314.99(b) for ANDA
applicants) has been approved under OMB control number 0910-0001. In
accordance with the PRA, before publication of the final guidance
document, FDA intends to solicit public comment and obtain OMB approval
for any information collections recommended in this guidance that are
new or that would represent material modifications to previously
approved collections of information found in FDA regulations.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.

    Dated: May 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-11784 Filed 5-31-18; 8:45 am]
BILLING CODE 4164-01-P


----- Forwarded by Melanie King/RTP/USEPA/US on 08/05/2010 04:41 PM
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| From:      |
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  |"Bromberg, Kevin L."<EMAIL_ADDRESS>
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| To:        |
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  |Melanie King/RTP/USEPA/US@EPA, RobertJ Wayland/RTP/USEPA/US@EPA
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  >---------------------------------------------------------------------------
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|------------>
| Cc:        |
|------------>
  >---------------------------------------------------------------------------
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  |"Higgins, Cortney"<EMAIL_ADDRESS>"Kymn, Christine J."
<EMAIL_ADDRESS>Michael Horowitz/DC/USEPA/US@EPA, |
  |Fred Talcott/DC/USEPA/US@EPA
|
  >---------------------------------------------------------------------------
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|------------>
| Date:      |
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  |08/03/2010 05:15 PM
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| Subject:   |
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  |FW: NOx Reductions vs. HCHO Reductions - More Technical Information - can
be shared with EPA                                              |
  >---------------------------------------------------------------------------
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I told Peter that I would share this with EPA so we can get its comments in a
timely manner.  This affects the NOx benefits from 4SRB engines.

Cortney – I’m working on a consolidated document to share with EPA.
This has more details on the NOx issue than that document will have.

Kevin

From: Bromberg, Kevin L.
Sent: Monday, August 02, 2010 1:31 PM
To: 'Higgins, Cortney'; 'Kymn, Christine J.'
Cc: 'Lee, Amanda I.'<EMAIL_ADDRESS>'Zwicke, Greg - Portland,
OR'
Subject: NOx Reductions vs. HCHO Reductions - More Technical Information
- can be shared with EPA

If you get NOx reduction with NSCR it is usually relatively high – e.g., 90%
or more.  The problem is that the NOx performance is very sensitive to the air
to fuel ratio (AFR) and the stream needs to be “more rich” (i.e., more fuel
rich or air deficient).  A lesser NOx reduction (e.g., 20 – 60% NOx reduction)
with NSCR is typically not seen, because the performance curve (versus AFR) is
very steep – meaning that you go from no NOx reduction to relatively high NOx
reduction (e.g., 80% or
more) with very small changes to AFR.  Similarly, if set for “richer”
operation with NOx reduction, relatively small changes in AFR can move the AFR
more lean and significantly impact NOx performance.  Thus, if an operator
installs NSCR to meet a NOx limit, the set to provide a better assurance of
emission performance is often accomplished by establishing a “richer” set
point (which can result in significant ammonia emissions).  In this scenario,
there is more of an operating window before minor AFR changes can move “too
lean” and significantly compromise NOx performance.  Those richer set point
also result in lower efficiency / higher fuel use, more hydrocarbon (HC)
emissions, and hotter operation – and these conditions affect maintenance
requirements because the HC and higher temps impact performance and increase
maintenance frequency (and related costs).

An example of NOx (post NSCR catalyst) versus AFR for a RB with NSCR is
provided here. Note the “stoichiometric ratio” (SR) is the theoretical amount
of air relative to the amount required to burn all of the fuel – i.e., at 1.00
there is just enough air to burn all the fuel.  From the scale on the x-axis,
a change in the amount of air by 1 or 2% dramatically changes the NOx
emissions (and ammonia and CO emissions).
This level of AFR control is difficult to maintain on a continuous basis. It’s
also not reasonable to operate in a region of the “NOx curve” that provides
intermediate levels of NOx reduction so in general NOx reduction with NSCR
close to an all or nothing proposition. Also – as a reminder, the definition
of “rich burn” is an engine with a stoichiometric ratio up to 1.10 (beyond the
scale of this graph).  As you can see from the graph, the NOx emissions on the
right side of the graph (from SR of about 0.99 or higher) have high NOx
indicative of very little or no NOx reduction.  This relates to our discussion
that NOx reductions cannot be presumed with NSCR – and operators can achieve
better efficiency, lower fuel use, and lower greenhouse gas emissions by
running leaner where NSCR will not reduce NOx.

Also for the NOx data – the marginal relative change in the 3 data points to
the right (from about 2100 to about 2650 ppmv) is due to changes in the inlet
NOx and not from NSCR reduction – i.e., the inlet NOx versus AFR is also
dependent on AFR at this operating threshold where you cross from “rich” to
“lean”, and the NOx reduction across the catalyst is insignificant.  Note that
the one NOx point at about 850 ppmv is 58% reduction and the three low NOx
points on the left are about 98% reduction for these tests.

(Embedded image moved to file: pic09770.gif) Since facilities will be
attempting to meet a HCHO standard in the neighborhood of 3.7 ppm, the
preferred operation will use a stoichiometric ratio of 0.99 or more, which
would be on the “fuel lean”
side (right hand side) of the graph.  However, the NOx reductions will only
occur on the rich side (left hand side) of the graph – in this case
approximately 0.98 or less.  In addition to good HCHO emissions performance,
there are additional reasons for being on the lean side of the curve – reduced
fuel consumption, associated reductions in greenhouse gas emissions (i.e.,
lower CO2 and methane), reduced maintenance, and avoidance of ammonia and CO
emissions.  The NOx reductions go very quickly from roughly 98% to 0% once you
move from
richer settings to leaner operation above about 0.98.   Also, the air to
fuel ratio differences are very small and given some instability of the
settings of these engines, maintaining a precise setpoint is difficult and you
will need to set an even leaner setting optimize engine operability and
effieciency – or, conversely, set a richer setting to
ensure NOx reductions.   The above graph is from a rich burn engine
tested by Colorado State University. Unless EPA is also setting a NOx limit
with the HCHO limit, these desired NOx reductions are unlikely to occur.

EPA may wish to review additional data to see how under what AFR ratios, both
the HCHO number and the desired NOx reductions can occur (by how much and
whether these overlap), although I don’t know how this result can be achieved
under the current standard.

This argues that our NOx reductions will be lower for the 300-500 HP major
sources and the >500 HP area sources, and reinforces our argument to drop the
NSCR for sources <750 HP and in rural America.


[Federal Register Volume 86, Number 160 (Monday, August 23, 2021)]
[Rules and Regulations]
[Pages 46989-46992]
[FR Doc No: 2021-17292]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 62

[EPA-R02-OAR-2020-0431, FRL-8851-02-Region 2]

Approval and Promulgation of State Plans for Designated
Facilities; New York; Revision to Section 111(d) State Plan for MSW
Landfills

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is approving a
revision to New York's section 111(d) state plan (the ``State Plan'')
for Municipal Solid Waste (MSW) landfills, pursuant to the Clean Air
Act (``CAA'' or the ``Act''). The State Plan revision consists of
amendments to ``Landfill Gas Collection and Control Systems for Certain
Municipal Solid Waste Landfills,'' as well as attendant revisions to
the ``General Provisions.'' New York has implemented this regulation to
incorporate by reference the revised Emission Guideline (EG)
promulgated by the EPA for existing MSW landfills on August 29, 2016.
The purpose of the revised Emission Guideline is to reduce emissions of
landfill gas containing Non-methane Organic Compounds (NMOC) and
methane by lowering the emission threshold at which an existing MSW
landfill must install and operate a Gas Collection and Control System
(GCCS). The emissions threshold reduction will address air emissions
from all affected MSW landfills, including NMOC and methane. The
reduction of emissions will improve air quality and protect the public
health from exposure to landfill gas emissions.

DATES: This final rule is effective on September 22, 2021. The
incorporation by reference of certain material listed in the rule is
approved by the Director of the Federal Register September 22, 2021.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R02-OAR-2020-0431. All documents in the docket are
listed on the http://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g.,
confidential business information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available through www.regulations.gov, or please contact the person
identified in the For Further Information Contact section for
additional available information.

FOR FURTHER INFORMATION CONTACT:
    Fausto Taveras, Environmental Protection Agency, Region 2, 290
Broadway, New York, New York 10007-1866, at<PHONE_NUMBER>, or by email
at<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: The Supplementary Information section is
arranged as follows:

I. What action is the EPA taking today?
II. What are the details of the EPA's action?
III. What comments were received in response to the EPA's proposed
action?
IV. What action is the EPA taking?
V. Incorporation by Reference
VI. Statutory and Executive Order Reviews

I. What action is the EPA taking today?

    The EPA is approving the State of New York's revised section 111(d)
state plan for MSW landfills, for the purpose of incorporating the
adoption of Title 6 of the New York Codes, Rules, and Regulations
(NYCRR) Part 208. In a letter dated December 11, 2019, the New York
State Department of Environmental Conservation (NYSDEC), on behalf of
the State of New York, submitted to the EPA a state plan entitled,
``Landfill Gas Collection and Control Systems for Certain Municipal
Solid Waste Landfills,'' which contains a New York State-approved
regulation for the purpose of lowering the emissions threshold within
MSW landfills through the installation of Gas Collection and Control
Systems (GCCS). The State Plan incorporates by reference the revised
Emission Guidelines (EG) codified at 40 CFR part 60 subpart Cf, which
applies to MSW landfills that have accepted waste at any time since
November 8, 1987, and commenced construction, reconstruction, or
modification on or before July 17, 2014.
    In accordance with the CAA, New York previously submitted a state
plan on October 8, 1998, which was approved by the EPA on July 19,
1999. See 64 FR 38582 (Jul. 19, 1999). New York submitted a revised
State Plan dated December 11, 2019 to fulfill the requirements of
section 111(d) of the Act. The EPA is approving New York's State Plan
revision since it applies to major sources of NMOC and methane
emissions. This approval, once finalized and effective, will render New
York's revised MSW rule federally enforceable.

II. What are the details of the EPA's action?

    On March 12, 1996, the EPA promulgated federal Emission Guidelines
(1996 EG), codified at 40 CFR part 60 subpart Cc, ``Standards of
Performance for New Stationary Sources and Guidelines for Control of
Existing Sources: Municipal Solid Waste Landfills.'' See 61 FR 9905
(Mar. 12, 1996). Under the 1996 EG, a state plan must include the
installation of a gas collection and control system at each MSW
landfill that accepted waste after November 8, 1987, has a design
capacity greater than or equal to 2.5 million Megagrams (Mg) and 2.5
million cubic meters, and that emits NMOC at a rate of 50 Mg per year
or more. See 40 CFR 60.33c(b). In accordance with section 111 of the
CAA, on September 24, 2001, the NYSDEC promulgated 6 NYCRR Part 208,
``Landfill Gas Collection and Control Systems for Certain Municipal
Solid Waste Landfills,'' in compliance with the EPA's federal EG for
MSW landfills, codified at 40 CFR part 60 subpart Cc.
    Due to significant changes within the landfill industry, such as
increased scientific understanding of landfill gas emissions, changes
in operation practices, and an increase in the average size and age of
landfills, the EPA determined that it was appropriate to update the
1996 EG. As a result, on August 29, 2016, the EPA promulgated a revised
EG, codified at 40 CFR part 60 subpart Cf, entitled, ``Emission
Guidelines and Compliance Times for Municipal Solid Waste Landfills.''
See 81 FR 59275 (Aug. 29, 2016). The revised EG updated the control
requirements, monitoring, reporting, and recordkeeping provisions for
existing MSW landfill sources. The revised EG is designed to
significantly reduce emissions of landfill gas containing NMOC and
methane by further reducing the emissions threshold at which a landfill
must install and operate a GCCS. In contrast to the 1996 EG, the
revised EG reduces the threshold for installing a GCCS to 34 Mg/year of
NMOC for active MSW landfills. Meanwhile, closed MSW landfills will
retain the threshold of 50 Mg/year of NMOC for installing a GCCS. In
order to continue complying with the Act and the newly adopted EG, on
August 5, 2019, New York adopted its revised 6 NYCRR Part 208,
``Landfill Gas Collection and Control Systems for Certain Municipal
Solid Waste Landfills,'' and amended Part 200, ``General Provisions,''
with an effective date of September 4, 2019. The purpose of the
revisions was to incorporate by reference the revised EG for MSW
landfills promulgated at 40 CFR part 60 subpart Cf.
    In its proposal (see 86 FR 11485 (Feb. 25, 2021)), the EPA
evaluated New York's State Plan for compliance with regulations at 40
CFR part 60 subpart Ba governing the timing and completeness
requirements for the submission of state plans. See 40 CFR 60.23a and
60.27a. On August 26, 2019, the EPA finalized a rule (referred to as
the ``Ba Rule'') that amended the EG codified at 40 CFR part 60 subpart
Cf to incorporate these subpart Ba timing and completeness
requirements. See 84 FR 44547 (Aug. 26, 2019); 40 CFR 60.30f. However,
on January 19, 2021, the D.C. Circuit issued a decision vacating these
requirements of subpart Ba, see Am. Lung Ass'n v. EPA, 985 F.3d 914,
991-95, and the court subsequently also vacated the Ba Rule in an April
5, 2021 order, see Environmental Defense Fund v. EPA, No. 19-1222, Dkt.
1893133. Accordingly, the review of New York's State Plan is no longer
subject to the timing and completeness requirements of the Ba Rule, and
the requirements of 40 CFR part 60 subpart B (sections 60.23 and 60.27)
now apply instead.
    The court's vacatur of the Ba Rule does not affect the
approvability of New York's State Plan. First, the completeness
requirements of subpart Ba evaluated at proposal no longer apply, and
New York's State Plan meets the applicable requirements of 40 CFR 60.23
and 60.27. Further, the vacatur did not affect the substantive
requirements of the EG at 40 CFR part 60 subpart Cf.

III. What comments were received in response to the EPA's proposed
action?

    The EPA received four comments during the 30-day public comment
period in response to its February 25, 2021 proposed approval of New
York's State Plan revision. The specific comments may be viewed under
Docket ID Number EPA-R02-OAR-2020-0431 on the http://www.regulations.gov website. Two public comments, posted on March 2,
2021 and March 26, 2021, support the EPA's proposed rulemaking to
approve New York's revised State Plan.
    Two public comments, received on March 28, 2021 and March 29, 2021,
were submitted by the New York Chapter of the Solid Waste Association
of North America (SWANA-NY) and the National Waste & Recycling
Association (NWRA). Both comments are substantially similar and
acknowledge that New York's State Plan was submitted to the EPA on
December 11, 2019. However, on March 26, 2020, the EPA promulgated the
National Emission Standards for Hazardous Air Pollutants: Municipal
Solid Waste Landfills Residual Risk and Technology Review (NESHAP MSW
RTTR) (85 FR 17244). This final rule revised the most recent MSW
Landfill New Source Performance Standards (NSPS) (see 40 CFR part 60
subpart XXX) and EG (subpart Cf) in order to allow affected MSW
landfills to demonstrate compliance with the ``major compliance
provisions'' of the NESHAP (40 CFR part 63 subpart AAAA) in lieu of
complying with analogous provisions in the NSPS and EG. This revision
permits affected MSW

landfills to follow one set of operational, compliance, monitoring, and
reporting provisions for pressure and temperature measurements. The
commenters state that since New York's State Plan submittal predates
the NESHAP MSW RTTR, it does not incorporate the NESHAP MSW RTTR. Both
commenters recommend that the approval of New York's State Plan be
contingent on including these changes.
    The NESHAP MSW RTTR does not require affected MSW landfills to
demonstrate compliance with the ``major compliance provisions'' of the
NESHAP AAAA in lieu of complying with the NSPS (subpart XXX) and the EG
(subpart Cf). Instead, sources can, depending on the circumstances,
demonstrate compliance through either the NESHAP AAAA, the NSPS, or the
EG. With respect to the EG, the March 26, 2020 revisions to subpart Cf
permitted, but did not require, states to adopt the updates provided in
the rule into their section 111(d) state plans. Accordingly, New York's
State Plan is approvable as submitted, despite the fact that it
predates the promulgation of the NESHAP MSW RTTR, because it meets all
of the requirements of 40 CFR part 60 subpart Cf.
    This concludes our response to the comments received. No changes
have been made to the proposed rule as a result of the comments.

IV. What is the EPA's conclusion?

    The EPA has determined that New York's revised State Plan meets all
the applicable approval criteria as discussed above and, therefore, the
EPA is approving New York State's CAA section 111(d) revised State Plan
for existing municipal solid waste landfills.

V. Incorporation by Reference

    In this document, the EPA is finalizing regulatory text that
includes incorporation by reference. In accordance with the
requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by
reference of the 6 NYCRR Part 208, ``Landfill Gas Collection and
Control Systems for Certain Municipal Solid Waste Landfills,''
regulation described in the amendments to 40 CFR part 62 set forth
below. The EPA has made, and will continue to make, these materials
generally available through www.regulations.gov, Docket No. EPA-R02-
OAR-2020-0431 and in hard copy at the EPA Region 2 Office (please
contact the person identified in the For Further Information Contact
section of this preamble for more information).

VI. Statutory and Executive Order Reviews

    Pursuant to EPA regulations, the Administrator may approve a plan
or any portion thereof upon a determination that it meets sections
111(d) and 129 of the Act and applicable regulations. See 40 CFR 62.02.
    Accordingly, this action, once finalized, would merely approve
state law that meets federal requirements, and would not impose
additional requirements beyond those imposed by state law. For that
reason, this action, once finalized:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735 (Oct. 4, 1993)); and Executive Order 13563 (76 FR
3821 (Jan. 21, 2011));
     Is not an Executive Order 13771 (82 FR 9339 (Feb. 3,
2017)) regulatory action because section 111(d) plan 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 (Aug. 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 the 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 (Feb. 16, 1994)).
    In addition, this rule is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications, and will
not impose substantial direct compliance costs on tribal governments,
or preempt tribal law, as specified by Executive Order 13175 (65 FR
67249 (Nov. 9, 2000)).

List of Subjects in 40 CFR Part 62

    Environmental protection, Administrative practice and procedure,
Air pollution control, Incorporation by reference, Intergovernmental
relations, Landfills, Reporting and recordkeeping requirements, Waste
treatment and disposal.

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

    Dated: August 6, 2021.
Walter Mugdan,
Acting Regional Administrator, Region 2.

    For the reasons stated in the preamble, the Environmental
Protection Agency amends 40 CFR part 62 as set forth below:

PART 62--APPROVAL AND PROMULGATION OF STATE PLANS FOR DESIGNATED
FACILITIES AND POLLUTANTS

0
1. The authority citation for part 62 continues to read as follows:

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

Subpart HH--New York

0
2. Section 62.8104 is revised to read as follows:

Sec.  62.8104   Identification of plan.

    (a) Identification of plan. On December 11, 2019, the New York
State Department of Environmental Conservation (NYSDEC) submitted to
the Environmental Protection Agency (EPA) a Clean Air Act revised
section 111(d) state plan, to incorporate revisions to Title 6 NYCRR
Parts 208 and 200 for the implementation of 40 CFR part 60, subpart Cf,
``Emissions Guidelines for Municipal Solid Waste Landfills.''
    (b) Identification of sources. The plan applies to all existing
municipal solid waste landfills under the jurisdiction of the New York
State Department of Environmental Conservation that have accepted waste
after November 8, 1987, and began construction, reconstruction, or
modification on or prior to July 17, 2014, and have a design capacity
threshold of 2.5 million megagrams (Mg) and 2.5 million cubic meters,
as described in 40 CFR 60 subpart Cf.
    (c) Effective date. The effective date of the plan for September
22, 2021.
    (d) Incorporation by reference. (1) The material incorporated by
reference in

this section was approved by the Director of the Federal Register
Office in accordance with U.S.C. 552(a)(1) and 1 CFR part 51. The
material is available from the sources identified elsewhere in this
paragraph. It may be inspected or obtained from the EPA Region 2
Office, 290 Broadway, 25th Floor, New York, New York 10007-1866, 212-
637-3378. Copies may be inspected at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, email<EMAIL_ADDRESS>or go to:
www.archives.gov/federal-register/cfr/ibr-locations.html.
    (2) State of New York, Department of State, Albany, New York 12231;
https://dos.ny.gov/state-register.
    (i) 6 NYCRR Part 208: Official Compilation of (New York) Codes,
Rules and Regulations; Title 6--Environmental Conservation; Part 208--
Landfill Gas Collection and Control Systems for Certain Municipal Solid
Waste Landfills, effective September 4, 2019.
    (ii) [Reserved]

[FR Doc. 2021-17292 Filed 8-20-21; 8:45 am]
BILLING CODE 6560-50-P