[Federal Register: June 29, 2006 (Volume 71, Number 125)]
[Notices]
[Page 37099-37120]
[DOCID:fr29jn06-79]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration (OSHA)

Susan Harwood Training Grant Program, FY 2006 Budget

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

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Funding Opportunity No.: SHTG-FY-06-01
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 education programs for employers and workers about
safety and

health topics selected by OSHA. Nonprofit organizations, including
community-based and faith-based organizations, that are not an agency
of a State or local government, are eligible to apply. 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. This notice
contains all of the necessary information and forms needed to apply for
grant funding.

DATES: Grant applications must be received by the OSHA Office of
Training and Education in Arlington Heights, Illinois, by 4:30 p.m.
(central time) on Friday, July 21, 2006.

ADDRESSES: Grant applications must be sent to the attention of: Grants
Officer, U.S. Department of Labor, OSHA Office of Training and
Education, 2020 S. Arlington Heights Road, Arlington Heights, Illinois
60005-4102.

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 three areas:
     Educating workers and employers in small businesses. A
small business has 250 or fewer workers.
     Training workers and employers about new OSHA standards.
     Training workers and employers about high risk activities
or hazards identified by OSHA through its Strategic Management Plan, or
as part of an OSHA special emphasis program.

Grant Category Being Announced

    OSHA will accept applications for the Targeted Topic training grant
category in FY 2006.

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 people 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 must be included in the
training.
    Ten 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 wishing to address more than
one of the announced grant 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 for one of the topics
listed below.
    Construction Industry Hazards. Programs that train workers and
employers in the recognition and prevention of safety and health
hazards on one of the following topics:
     Falls in construction, including residential construction.
Applicants must propose to conduct this training in English and
Spanish. Additional languages may also be proposed.
     Focus Four construction hazards (falls, electrocution,
caught-in and struck-by). Proposed training programs must include all
four hazards.
     Work zone safety, including highway construction work zone
safety and disaster site cleanup and recovery work zones.
    General Industry Hazards. Programs that train workers and employers
in the recognition and prevention of safety and health hazards on one
of the following topics:
     Amputation hazards, including lockout/tagout hazards
     Landscaping and Horticulture (NAICS 56173/SIC 078)
     Oil and gas field services (NAICS 21311-12/SIC 138)
    Other Safety and Health Topic Areas. Programs that train workers
and employers in the recognition and prevention of safety and health
hazards on one of the following topics:
     Disaster response and recovery
     Hexavalent chromium
     Workplace emergency planning, including the healthcare
industry
     Overview of OSHA safety and health requirements for Tribal
organizations and affected workers

II. Award Information

    Targeted Topic grants will be awarded for a 12-month period. The
project period for these grants begins September 30, 2006, and ends
September 30, 2007. There is approximately $6.8 million available for
this grant category. The average Federal award will be $175,000.

III. Eligibility Information

1. Eligible Applicants

    Nonprofit organizations, including community-based and faith-based
organizations, that are not an agency of a State or local government
are eligible to apply. 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, a
lead organization must be identified. Sub-contracts must be awarded in
accordance with 29 CFR 95.40-48, including OMB circulars requiring free
and open competition for procurement transactions.
    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, preferably from the Internal Revenue Service (IRS).

    Authority:  The Occupational Safety and Health Act of 1970 and
the Consolidated Appropriations Act, 2006, Pub. L. 109-149,
authorize this program.

2. Cost Sharing or Matching

    Applicants are not required to contribute non-Federal resources.

3. Other Eligibility Requirements

A. 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 know as ``discretionary''
assistance), as opposed to assistance that it receives from a State
or Local government (also know 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. Address To Request Application Forms

1. Application Forms

    Application forms are published as part of this Federal Register
notice and in the Federal Register, which may be obtained from your
nearest Federal depository library or online at http://www.archives.gov/federal-register/index.html.
 The complete Federal

Register notice and application forms may also be downloaded from 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 announced
topics. Organizations interested in applying for grants for more than
one of the announced topics must submit separate applications for each
topic.
A. Required Contents
    To be considered for a Harwood grant, an applicant must submit one
(1) blue-ink signed original complete application in English plus two
(2) copies that includes all of the information listed below. A
complete application will contain the following forms and narrative
sections. The parts are listed in the order in which they should appear
in the application.
    (a) 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.
    (b) Survey on Ensuring Equal Opportunity for Applicants form (OMB
No. 1890-0014).
    (c) Program Summary (described further in subsection B below). The
program summary is a short one-to-two page abstract that succinctly
summarizes the proposed project and provides information about the
applicant organization.
    (d) Budget Information form (SF 424A).
    (e) Detailed Project Budget Backup. The detailed budget backup will
provide a detailed break out 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.
    (f) A description of any voluntary non-Federal resource
contribution to be provided by the applicant, including source of funds
and estimated amount.
    (g) 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 Workplan.
    (h) Assurances form (SF 424B).
    (i) Certifications form (OSHA 189).
    (j) Supplemental Certification Regarding Lobbying Activities form.
    (k) Organizational Chart.
    (l) Evidence of Non-Profit status, preferably from the Internal
Revenue Service (IRS), if applicable. (Does not apply to State and
local government-supported institutions of higher education.)
    (m) 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:
    1. Accurate, current and complete disclosure of the financial
results of each Federally sponsored project.
    2. Records that identify adequately the source and application of
funds for Federally sponsored activities.
    3. Effective control over and accountability for all funds,
property and other assets.
    4. Comparison of outlays with budget amounts.
    5. Written procedures to minimize the time elapsing between the
transfer of funds.
    6. Written procedures for determining the reasonableness,
allocability and allowability of costs.
    7. Accounting records, including cost accounting records that are
supported by source documentation.
    (n) 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.
    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 (e.g., with tab dividers), 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 included as a part of this Federal
Register notice. The forms are also available on the OSHA grant web
page at http://www.osha.gov/dcsp/ote/sharwood.html.

B. Budget Information
    Applicants must include the following grant project budget
information.
    (a) Budget Information form (SF 424A).
    (b) 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 reminded to budget for compliance with the
administrative requirements set forth. (Copies of all regulations that
are referenced in this 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 Chicago area to attend a new grantee
orientation meeting; financial audit, if required; project closeout;
document preparation (e.g., quarterly progress reports, project
document); and ensuring compliance with procurement and property
standards. The Detailed Project Budget should identify 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 an 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 is
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).
    (c) 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 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
Workplan. 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.
    (a) Program Summary. An abstract of the application, not to exceed
two pages, that must include the following information.
     Applicant organization's full legal name.
     Project director's name, title, street address, 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.
     Certifying Representative's name, title, street address,
and mailing address if it is different from the street address,
telephone and fax numbers, and e-mail address. The Certifying
Representative is the official in your organization who is authorized
to enter into grant agreements.
     Funding requested. List how much Federal funding you are
requesting. If your organization is contributing non-Federal resources,
also list the amount of non-Federal resources and the source of the
funds.
     Grant Topic. List the grant topic and industry or subject
area your organization has selected to target in its application.
     Summary of the Proposed Project. Write a brief program
summary of your proposed project.
     Applicant Background. Describe your applicant
organization, including its mission and a description of your
membership, if any.
    (b) 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 education program, and the barriers
that have prevented this population from receiving adequate training.
When you discuss target populations, include geographic location(s),
and the number of workers and employers.
     Administrative and Program Capability. Briefly describe
your organization's functions and activities. Relate this description
of functions to your organizational chart that is included 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 title, 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 are
those with safety and health experience, training experience, or
experience working with the target population.
     Workplan. The 12-month workplan should correlate with the
grant project period that will begin September 30, 2006, and end
September 30, 2007. An outline of specific items required in your
workplan follows.
    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, the training content, recruiting of
trainees, where or how training will take place, and the anticipated
benefits to workers and employers receiving the training.
    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.
    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 do 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. 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
follow up with the trainers to obtain this data during the grant
period.
    Materials. Describe each educational 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. For Targeted Topic
training grants, any commercially-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 and 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 people 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.
    (c) 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; resumes of key
personnel and/or position descriptions; and signed letters of
commitment to the project.

3. Submission Date, Times, and Addresses

    Date: The closing date for receipt of applications is Friday, July
21, 2006. Applications must be received by 4:30 p.m. (central time) at
the address below. Applications sent by e-mail, telegram, or facsimile
(FAX) will not be accepted. Applications sent by other delivery
services, such as Federal Express, UPS, etc., will be accepted; the
applicant, however, bears the responsibility for timely submission.
Applications that do not meet the conditions set forth in this notice
will not be honored. No exceptions to the mailing and delivery
requirements set forth in this notice will be granted.
    Applications must be delivered to: Grants Officer, U.S. Department
of Labor, OSHA Office of Training and Education, 2020 S. Arlington
Heights Road, Arlington Heights, Illinois 60005-4102.
    One (1) blue ink-signed original complete application in English
plus two (2) copies of each application must be received at the
designated place by the date and time specified or it will not be
considered unless:
    (a) It was sent by registered or certified mail no later than the
fifth calendar day before the closing date; or
    (b) It was sent by U.S. Postal Service Express Mail/Next Day
Service from the post office to the addressee no later than 4:45 p.m.
at the place of mailing two (2) working days (excluding weekends and
Federal holidays and days when the Federal government is closed), prior
to the closing date; or
    (c) It is determined by the Government that the late receipt was
due solely to mishandling by the Government after receipt at the U.S.
Department of Labor at the address indicated.
    The only acceptable evidence to establish the date of mailing of a
late application sent by registered or certified mail is the U.S.
Postal Service postmark on the envelope or wrapper and on the original
receipt from the U.S. Postal Service. If the postmark is not legible,
an application received after the above closing time and date shall be
processed as if mailed late. ``Postmark'' means a printed, stamped, or
otherwise placed impression (not a postage meter machine impression)
that is readily identifiable without further action as having been
applied and affixed by an employee of the U.S. Postal Service on the
date of mailing. Therefore, applicants should request that the postal
clerk place a legible hand cancellation ``bulls-eye'' postmark on both
the receipt and the envelope or wrapper. The only acceptable evidence
to establish the date of mailing of a late application sent by U.S.
Postal Service Express Mail/Next Day Service from the Post Office to
the addressee is the date entered by the Post Office receiving clerk on
the ``Express Mail/Next Day Service--Post Office to Addressee'' label
and the postmark on the envelope or wrapper on the original receipt
from the U.S. Postal Service. ``Postmark'' has the same meaning as
defined above.

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 educational 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 workers in non-State Plan States, and workers
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.
    (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) 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 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 in September 2006.

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--45 Points Total
Program Design
    (1) The proposed training and education program must address the
recognition and prevention of safety and health hazards for one of the
Targeted Topic subject areas. (3 points)
    Construction Industry Hazards. Programs that train workers and
employers in the recognition and prevention of safety and health
hazards on one of the following topics:
     Falls in construction, including residential construction.
Applicants must propose to conduct this training in English and
Spanish. Additional languages may also be proposed.
     Focus Four construction hazards (falls, electrocution,
caught-in and struck-by). Proposed training programs must include all
four hazards.
     Work zone safety, including highway construction work zone
safety and disaster site cleanup and recovery work zones.
    General Industry Hazards. Programs that train workers and employers
in the recognition and prevention of safety and health hazards on one
of the following topics:
     Amputation hazards, including lockout/tagout.
     Landscaping and Horticulture (NAICS 56173/SIC 078)
     Oil and gas field services (NAICS 21311-12/SIC 138)
    Other Safety and Health Topics Areas. Programs that train workers
and employers in the recognition and prevention of safety and health
hazards on one of the following topics:
     Disaster response and recovery
     Hexavalent chromium
     Workplace emergency planning, including the healthcare
industry
     Overview of OSHA safety and health requirements for Tribal
organizations and affected workers
    (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. (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;
     The estimated number of courses to be conducted by the new
trainers;
     The estimated number of students to be trained by these
new trainers; and
     A description of how the grantee will obtain data from the
new trainers documenting their classes and student numbers.
    (4) The workplan activities and training are described. The planned
activities and training are 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. The training materials and
training programs are tailored to the training needs of one or more of
the following target audiences: small businesses; new businesses;
limited English proficiency, 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. Organizations proposing to develop Spanish-language training
materials should 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. (20 points)
    (5) There is a plan to recruit trainees for the program. (3 points)
    (6) If the proposal includes developing educational materials for
use in the training program, there is a plan for OSHA to review the
educational materials for technical accuracy and suitability of content
during development. If commercially-developed training products will be
used for the Targeted Topic training program, applicants should also
plan for OSHA to review the materials before using the products in
their grant program. (3 points)
    (7) 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)
    (8) The application is complete, including forms, budget detail,
narrative and workplan, and required attachments. (3 points)
B. Budget--20 Points Total
    (1) The budgeted costs are reasonable. No more than 25% of the
total budget is for administration. (10 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. (5
points)
    (3) The cost per trainee is less than $500 and the cost per
training hour is reasonable. (5 points)
C. Past Performance--18 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. (5 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. (5 points)
    (3) The application organization demonstrates that the applicant
has strong financial management and internal control systems. (5
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--17 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 population your organization proposes to serve under
the grant. (7 points)

2. Review and Selection Process

    OSHA will screen all applications to determine whether all required
proposal elements are present and clearly identifiable. Those that do
not 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 by September 30,
2006. The grant agreement will be awarded by no later than September
30, 2006.

VI. Award Administration Information

1. Award Process

    Organizations selected as grant recipients will be notified by a
representative of the Assistant Secretary, usually from an OSHA
Regional Office. 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 the 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, if
applicable.
    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.
    Students. Grant-funded training programs must serve multiple
employers and their employees. Grant-funded training programs must
serve individuals covered by the Occupational Safety and Health Act of
1970. 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 subgranting opportunities to Historically Black
Colleges and Universities, Hispanic Serving Institutions, and Tribal
Colleges and Universities.

3. Special Program Requirements

    OSHA review of educational 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 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 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 XP Word and PowerPoint.
    As listed in 29 CFR 95.36, the Department of Labor reserves a
royalty-free, nonexclusive and irrevocable right to reproduce, publish,
or otherwise use any work produced under a grant, for Federal purposes,
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 them 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: In consultation
with USDOL--OSHA, the Grantee(s) must acknowledge USDOL's role as
described below:
     The USDOL-OSHA logo may be applied to USDOL-funded
material prepared for world-wide distribution, including posters,
videos, pamphlets, research documents, national survey results, impact
evaluations, best practice reports, and other publications of global
interest. The Grantee(s) must consult with USDOL-OSHA on whether the
logo may be used on any such items prior to final draft or final
preparation for distribution. In no event shall the USDOL-OSHA logo be
placed on any item until USDOL-OSHA has given the Grantee written
permission to use the logo on the item.
     All documents must include the following notice: ``This
document 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.

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 and shall be
submitted to the appropriate OSHA Regional Office.
    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) 269A, Financial Status
Report, to report the status of the funds, at the project level, during
the grant period. A final SF269A shall be submitted no later than 90
days following completion of the grant period.
    If the Grantee(s) uses the U.S. Department of Health and Human
Services Payment Management System (HHS PMS), it must also send USDOL
copies of the PSC 272 that it submits to HHS, on the same schedule.
Otherwise, the Grantee(s) shall submit Standard Form (SF) 272, Federal
Cash Transactions Report, on the same schedule as the SF269A.
    Technical Program: 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 and a narrative
report shall be provided that details grant activities conducted during
the quarter, information on 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 work.

VII. Agency Contacts

    Any questions regarding this SGA should be directed to Cynthia
Bencheck, e-mail address<EMAIL_ADDRESS>tel:<PHONE_NUMBER>
(note that this is not a toll-free number), or Ernest Thompson,
<EMAIL_ADDRESS>tel:<PHONE_NUMBER>. To obtain further

information on the Susan Harwood Training Grant Program of the U.S.
Department of Labor, visit the OSHA Web site of the Occupational Safety
and Health Administration at http://www.osha.gov.

    Signed at Washington, DC, this 23rd day of June, 2006.
Edwin G. Foulke, Jr.,
Assistant Secretary of Labor.

Project Document Format

SF 424, Application for Federal Assistance form

    Your organization is required to have a Data Universal Number
System (DUNS) number (received 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.

Survey on Ensuring Equal Opportunity for Applicants form, OMB No. 1890-
0014
Program Summary (not to exceed two pages)
Budget Information, SF 424A form
Detailed Project Budget Backup

    If applicable: provide a copy of approved indirect cost rate
agreement, and statement of program income.
    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
Workplan
Assurances (SF 424B)
Certifications form (OSHA 189)
Supplemental Certification Regarding Lobbying Activities
Organizational Chart
Evidence of Nonprofit status, (letter from the IRS) if applicable
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:

    1. Accurate, current and complete disclosure of the financial
results of each Federally sponsored project.
    2. Records that identify adequately the source and application of
funds for Federally sponsored activities.
    3. Effective control over and accountability for all funds,
property and other assets.
    4. Comparison of outlays with budget amounts.
    5. Written procedures to minimize the time elapsing between the
transfer of funds.
    6. Written procedures for determining the reasonableness,
allocability and allowability of costs.
    7. Accounting records, including cost accounting records, that are
supported by source documentation.
    Attachments such as:
    Summaries of other relevant organizational experience; information
on prior government grants; resumes of key personnel or position
descriptions; signed letters of commitment to the project.

Attachments (Forms)

SF-424, Application for Federal Assistance.
Survey on Ensuring Equal Opportunity for Applicants form, OMB No. 1890-
0014.
SF-424A, Budget Information form.
SF 424B, Assurances.
OSHA 189 form, Certification.
Supplemental Certification Regarding Lobbying Activities.
    The forms are also available at: http://www.osha.gov/dcsp/ote/sharwood.htmlBILLING
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[FR Doc. 06-5790 Filed 6-28-06; 8:45 am]

BILLING CODE 4510-26-C


[Federal Register Volume 78, Number 179 (Monday, September 16, 2013)]
[Rules and Regulations]
[Pages 56829-56830]
[FR Doc No: 2013-21895]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 30919; Amdt. No. 3554]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This rule establishes, amends, suspends, or revokes Standard
Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums
and Obstacle Departure Procedures for operations at certain airports.
These regulatory actions are needed because of the adoption of new or
revised criteria, or because of changes occurring in the National
Airspace System, such as the commissioning of new navigational
facilities, adding new obstacles, or changing air traffic requirements.
These changes are designed to provide safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective September 16, 2013. The compliance date
for each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of September 16, 2013.

ADDRESSES: Availability of matter incorporated by reference in the
amendment is as follows:
    For Examination--
    1. FAA Rules Docket, FAA Headquarters Building, 800 Independence
Avenue SW., Washington, DC 20591;
    2. The FAA Regional Office of the region in which the affected
airport is located;
    3. The National Flight Procedures Office, 6500 South MacArthur
Blvd., Oklahoma City, OK 73169 or,
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    Availability_All SIAPs are available online free of charge. Visit
nfdc.faa.gov to register. Additionally, individual SIAP and Takeoff
Minimums and ODP copies may be obtained from:
    1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building,
800 Independence Avenue SW., Washington, DC 20591; or
    2. The FAA Regional Office of the region in which the affected
airport is located.

FOR FURTHER INFORMATION CONTACT: Richard A. Dunham III, Flight
Procedure Standards Branch (AFS-420) Flight Technologies and Programs
Division, Flight Standards Service, Federal Aviation Administration,
Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma
City, OK 73169 (Mail Address: P.O. Box 25082 Oklahoma City, OK 73125),
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14, Code of Federal
Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs.
The complete regulatory description of each SIAP is listed on the
appropriate FAA Form 8260, as modified by the National Flight Data
Center (FDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated
by reference in the amendment under 5 U.S.C. 552(a), 1 CFR part 51, and
Sec.  97.20 of Title 14 of the Code of Federal Regulations.
    The large number of SIAPs, their complex nature, and the need for a
special format make their verbatim publication in the Federal Register
expensive and impractical. Further, airmen do not use the regulatory
text of the SIAPs, but refer to their graphic depiction on charts
printed by publishers of aeronautical materials. Thus, the advantages
of incorporation by reference are realized and publication of the
complete description of each SIAP contained in FAA form documents is
unnecessary. This amendment provides the affected CFR sections and
specifies the types of SIAP and the corresponding effective dates. This
amendment also identifies the airport and its location, the procedure
and the amendment number.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP as amended in the transmittal. For safety and
timeliness of change considerations, this amendment incorporates only
specific changes contained for each SIAP as modified by FDC/P-NOTAMs.
    The SIAPs, as modified by FDC P-NOTAM, and contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these changes to
SIAPs, the TERPS criteria were applied only to specific conditions
existing at the affected airports. All SIAP amendments in this rule
have been previously issued by the FAA in a FDC NOTAM as an emergency
action of immediate flight safety relating directly to published
aeronautical charts. The circumstances which created the need for all
these SIAP amendments requires making them effective in less than 30
days.
    Because of the close and immediate relationship between these SIAPs
and safety in air commerce, I find that notice and public procedure
before adopting these SIAPs are impracticable and contrary to the
public interest and, where applicable, that good cause exists for
making these SIAPs effective in less than 30 days.

Conclusion

    The FAA has determined that this regulation only involves an
established

body of technical regulations for which frequent and routine amendments
are necessary to keep them operationally current. It, therefore--(1) is
not a ``significant regulatory action'' under Executive Order 12866;
(2) is not a ``significant rule'' under DOT regulatory Policies and
Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant
preparation of a regulatory evaluation as the anticipated impact is so
minimal. For the same reason, the FAA certifies that this amendment
will not have a significant economic impact on a substantial number of
small entities under the criteria of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

    Air traffic control, Airports, Incorporation by reference, and
Navigation (air).

    Issued in Washington, DC, on August 30, 2013.
John Duncan,
Deputy Director, Flight Standards Service.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14,
Code of Federal regulations, Part 97, 14 CFR part 97, is amended by
amending Standard Instrument Approach Procedures, effective at 0901 UTC
on the dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120,
44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:

Sec. Sec.  97.23, 97.25, 97.27, 97.29, 97.31, 97.33, 97.35  [AMENDED]

    By amending: Sec.  97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or
TACAN; Sec.  97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Sec.
97.27 NDB, NDB/DME; Sec.  97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV;
Sec.  97.31 RADAR SIAPs; Sec.  97.33 RNAV SIAPs; and Sec.  97.35 COPTER
SIAPs, Identified as follows:

* * * Effective Upon Publication

--------------------------------------------------------------------------------------------------------------------------------------------------------
     AIRAC Date         State            City               Airport         FDC No.    FDC Date                          Subject
--------------------------------------------------------------------------------------------------------------------------------------------------------
10/17/13............  CA         Beckwourth.........  Nervino............     3/0171    8/22/13  Takeoff Minimums and (Obstacle) DP, Orig
10/17/13............  MN         Grand Marais.......  Grand Marais/Cook       3/0179    8/22/13  NDB RWY 27, Orig-C
                                                       County.
10/17/13............  MT         Libby..............  Libby..............     3/0982    8/22/13  GPS A, Orig-B
10/17/13............  IL         Lawrenceville......  Lawrenceville-          3/1650    8/22/13  RNAV (GPS) RWY 18, Amdt 1
                                                       Vincennes Intl.
10/17/13............  IL         Lawrenceville......  Lawrenceville-          3/1653    8/22/13  VOR RWY 18, Amdt 1
                                                       Vincennes Intl.
10/17/13............  IL         Lawrenceville......  Lawrenceville-          3/1654    8/22/13  RNAV (GPS) RWY 9, Amdt 1
                                                       Vincennes Intl.
10/17/13............  IL         Lawrenceville......  Lawrenceville-          3/1657    8/22/13  RNAV (GPS) RWY 36, Amdt 1
                                                       Vincennes Intl.
10/17/13............  IL         Lawrenceville......  Lawrenceville-          3/1658    8/22/13  RNAV (GPS) RWY 27, Amdt 1
                                                       Vincennes Intl.
10/17/13............  AK         Huslia.............  Huslia.............     3/5257    8/22/13  RNAV (GPS) RWY 3, Amdt 2
10/17/13............  OR         Scappoose..........  Scappoose               3/5978    8/22/13  VOR/DME A, Amdt 3
                                                       Industrial Airpark.
10/17/13............  IA         Creston............  Creston Muni.......     3/6601    8/22/13  RNAV (GPS) RWY 16, Amdt 1
10/17/13............  WA         Ellensburg.........  Bowers Field.......     3/7408    8/22/13  RNAV (GPS) C Orig
10/17/13............  IL         Lawrenceville......  Lawrenceville-          3/7901    8/22/13  VOR RWY 36, Amdt 1A
                                                       Vincennes Intl.
10/17/13............  MA         Lawrence...........  Lawrence Muni......     3/9394    8/22/13  RNAV (GPS) RWY 23, Orig
10/17/13............  MA         Lawrence...........  Lawrence Muni......     3/9395    8/22/13  VOR RWY 23, Amdt 11
10/17/13............  MA         Lawrence...........  Lawrence Muni......     3/9396    8/22/13  RNAV (GPS) RWY 5, Orig
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2013-21895 Filed 9-13-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 149 (Thursday, August 2, 2018)]
[Notices]
[Pages 37816-37817]
[FR Doc No: 2018-16524]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2657]

Advancing the Development of Pediatric Therapeutics 5: Advancing
Pediatric Pharmacovigilance; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Division of Pediatric and Maternal Health, Office of
Surveillance and Epidemiology, and Office of Pediatric Therapeutics,
Food and Drug Administration (FDA or the Agency) are announcing a
public workshop entitled ``Advancing the Development of Pediatric
Therapeutics 5: Advancing Pediatric Pharmacovigilance.'' The purpose of
this 1-day workshop is to provide a forum to gather information on the
latest developments in pediatric pharmacovigilance from the perspective
of various stakeholders and to expand the conversation to include the
utility and challenges of emerging pharmacovigilance tools, including
specific challenges associated with pediatric data tools.

DATES: The public workshop will be held on Friday, September 14, 2018,
from 8 a.m. to 5 p.m. See the SUPPLEMENTARY INFORMATION section for
registration date and information.

ADDRESSES: The public workshop will be held at FDAWhite Oak Campus,
10903 New Hampshire Ave. Bldg. 31 Conference Center, the Great Room
(Rm. 1503A), Silver Spring, MD 20993. Entrance for the public workshop
participants (non-FDA employees) is through Building 1 where routine
security check procedures will be performed. For parking and security
information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: For questions regarding the workshop,
contact Denise Pica-Branco, Center for Drug Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring,
MD 20993-0002,<PHONE_NUMBER>, [email protected]; or Meshaun
Payne, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-6668, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Drugs and biologics (products) receive marketing approval only
after undergoing premarket review and upon establishment of safety and
efficacy through adequate and well-controlled clinical trials. Because
all safety issues related to a product may not be detected in the
premarket phase, FDA receives and analyzes postmarket safety
information to determine if events reported in the postmarketing period
are likely to be related to exposure to a product. When FDA determines
that reported postmarketing events are likely related to a product, FDA
can introduce labeling changes and other activities to inform the
professional and lay public.

    FDA receives reports through the MedWatch website (https://www.fda.gov/Safety/MedWatch/HowToReport/default.htm), which are then
entered into the FDA Adverse Event Reporting System for subsequent
analysis. Because the volume of reports is large and because reporting
entities (product manufacturers and the professional or lay public)
need only suspect a possible link between product exposure and an
adverse event, FDA employs specific tools and strategies to assess
postmarket safety reports and potential signals that arise from review
of these reports. The process for receipt and assessment of such
postmarket safety information is referred to as pharmacovigilance.
    FDA has a specific regulatory mandate to perform pediatric
pharmacovigilance and to present or make available the results of such
pediatric pharmacovigilance to the Pediatric Advisory Committee.

II. Topics for Discussion at the Public Workshop

    In this workshop, FDA will gather information on the latest
developments in pediatric pharmacovigilance from the perspective of
various stakeholders and expand the conversation to include the utility
and challenges of emerging pharmacovigilance tools, including specific
challenges associated with pediatric data tools.

III. Participation in the Public Workshop

    Registration: Persons interested in attending this public workshop
must register online at https://www.eventbrite.com/e/advancing-the-development-of-pediatric-therapeutics-5-adept5-tickets-46654530958 by
Thursday, September 6, 2018, midnight Eastern Time. Please provide
complete contact information for each attendee, including name, title,
affiliation, address, email, and telephone. Onsite registration will
not be available.
    Registration for onsite participation or via webcast is free and
based on space availability, with priority given to early registrants.
Early registration is recommended because seating is limited;
therefore, FDA may limit the number of participants from each
organization. Registrants will receive confirmation when they have been
accepted.
    If you need special accommodations due to a disability, please
contact Denise Pica-Branco ([email protected]) or Meshaun
Payne ([email protected]) no later than Thursday, September 6,
2018.
    Streaming Webcast of the Public Workshop: Webcast information will
be provided after participants have registered for the workshop. If you
have never attended a Connect Pro event before, test your connection at
https://collaboration.fda.gov/common/help/en/support/meeting_test.htm.
To get a quick overview of the Connect Pro program, visit https://www.adobe.com/go/connectpro_overview.
    FDA has verified the website addresses in this document, as of the
date this document publishes in the Federal Register, but websites are
subject to change over time.

    Dated: July 27, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16524 Filed 8-1-18; 8:45 am]
 BILLING CODE 4164-01-P


Memorandum

To:	The Record

From:	Susan Parker Bodine

	Assistant Administrator

	Office of Solid Waste and Emergency Response

Re:	Meeting with National Mining Association representatives.

On June 4, 2008, Susan Bodine and Marcus Peacock met with the following
individuals regarding EPA’s proposed rule on the Definition of Solid
Waste:

Hal Quinn, NMA

Mike Wood, Freeport McMoran

Dave Kimball, Gallagher Kennedy

John Howard, Vinson & Elkins

The NMA representatives raised concerns about the potential regulation
under the proposed rule of a land based production process: leaching.
They were concerned that ambiguity of the term “contained” and the
term “significant release,” would be exploited later to try to
regulate this process as a waste management process.  They said a 1998
rule had made clear that this process was a production process, not
waste management.

I spoke about the proposal and the concept in the proposal that material
that has been released into the environment is discarded, and therefore
could be regulated.  The NMA representatives did not dispute that and
stated that the fact pattern they were describing did not involve any
release into the environment.  Instead, materials may move from one unit
into another unit.

I acknowledged that we had received comments requested clarification of
what “contained” and “significant release” means in the proposed
rule.