and Human Services (HHS)
EXPIRED
MINING SAFETY AND HEALTH TRAINING AND TRANSLATION CENTER
RELEASE DATE: February 9, 2004
RFA Number: RFA-OH-04-006
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
Centers for Disease Control and Prevention (CDC)
(http://www.cdc.gov)
COMPONENT OF PARTICIPATING ORGANIZATION:
National Institute for Occupational Safety and Health (NIOSH)
(http://www.cdc.gov/niosh/homepage.html)
NOTE: THE POLICIES, GUIDELINES, TERMS, AND CONDITIONS STATED IN THIS
ANNOUNCEMENT MAY DIFFER FROM THOSE USED BY THE NIH.
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): CFDA 93.262
LETTER OF INTENT RECEIPT DATE: March 18, 2004
APPLICATION RECEIPT DATE: April 16, 2004
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the RFA
o Research Objectives
o Mechanism(s)of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
National Institute for Occupational Safety and Health (NIOSH), Centers for
Disease Control and Prevention (CDC), announces the availability of fiscal
year (FY) 2004 funds for grant applications for mining safety and health
training and translation research to address mining operations in the Western
United States. Applications are sought that provide an integrated approach
for training mine workers and for translational research in order to improve
safety and health of the mining environment. Research projects that are
focused on topics other than translational research are not responsive to
this RFA.
PROGRAM OBJECTIVES
Background
Despite many technological and work environment advances, mining remains one
of the most dangerous occupations in the United States. The fatality rate in
mining is six times higher than the national average for other industries.
Additionally, the severity of injuries for mining exceeds all other
industries with the highest percentage of lost work days per incident.
Between 1987 and 1996, black lung disease caused the deaths of over 18,000
U.S. coal miners. In addition, more than 65 percent of miners experience
occupational hearing loss by the time they retire. With the increased demand
for coal to meet the nation’s energy needs, many of the health and safety
problems associated with mining will be increased such as noise levels,
methane gas levels, respirable dust levels etc. As a result, mining training
and translation research interests span a wide range of disciplines. In
addition, the objective of any translation project must explicitly address a
mining issue and not be a project that would only contribute to mining safety
and health as a secondary outcome.
Goals
This grant will support mining occupational health and safety education and
translational research projects that are developed to enhance the training of
mine workers and to foster the transfer of research findings to the mining
environment.
Objectives
The goal of this grant is to reduce the number of injuries to workers who are
involved in mining operations through an integrated program of training and
translational research. This grant is intended to support a Western United
States (referred to as Western in this document) program that 1) identifies
the training needs of mining personnel, 2) develops and conducts a Western
training program, 3) provides qualified instructors and faculty to train
mining personnel, 4)evaluates the effectiveness and impact of the training
program on reducing injuries to mining personnel, and 5) conducts
translational projects that convert mining occupational health research into
information, resources or tools. The training provided by this program
should satisfy current Occupational Safety and Health Administration (OSHA)
and Mine Safety and Health Administration (MSHA) recommendations and
guidelines.
See Useful References After AUTHORITY AND REGULATIONS (Below).
MECHANISM OF SUPPORT
This RFA will use the education project grant (R25) award mechanism. As an
applicant you will be solely responsible for planning, directing, and
executing the proposed project. This RFA is a one-time solicitation. Future
unsolicited, competing-continuation applications based on this project will
compete with all investigator-initiated applications and will be reviewed
according to the customary peer review procedures. The anticipated award
date is September 1, 2004. Applications that are not funded in the
competition described in this RFA may NOT be resubmitted as NEW investigator-
initiated applications as this is a not a recurring NIOSH program.
For this RFA, the Facilities and Administration (F&A) Costs are limited to
eight percent (8%) of the direct cost for the training activities. For the
translation projects, the established institutional rate will be used.
Approximately $450,000 of the direct costs for each year of the project must
be used for the training activities.
This RFA uses just-in-time concepts. It does not use the modular budgeting
formats. Follow the instructions for a detailed budget research grant
application. This program does not require cost sharing as defined in the
current NIH Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.
FUNDS AVAILABLE
NIOSH intends to commit approximately $1,000,000 in fiscal year (FY) 2004 to
fund one new and/or competitive continuation grant in response to this RFA.
An applicant may request a project period of up to five years and a budget
for total costs (direct costs, and facilities and administration (F&A)) of up
to $1,000,000 in the first year. In the second through fifth years, the
total costs that may be requested may not exceed $800,000. Applications
exceeding $1,000,000 in total costs in the first year or $800,000 in the
subsequent years will be considered unresponsive and returned without further
consideration. The F&A for the administrative and training components is
limited to an eight percent (8%) rate. The F&A rate for the translation
projects will be based on the established institution rate at the time of
award.
Although the financial plans of NIOSH provide support for this program,
awards pursuant to this RFA are contingent upon the availability of funds and
the receipt of a sufficient number of meritorious applications. At this time,
it is not known if this RFA will be reissued.
ELIGIBLE INSTITUTIONS
You may submit (an) application (s) if your institution is a domestic
organization and has any of the following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals,
and laboratories.
o Units of State and local governments
o Eligible agencies of the Federal government
o Faith-based organizations
o Federally recognized Indian Tribes, Tribal Governments, Colleges, and/or
Organizations
Because the focus of this training is on western mining operations, ease of
access is a significant consideration. Therefore, eligibility is limited to
institutions whose principal location is west of the Mississippi River.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Individuals with the skills, knowledge, and resources necessary to carry out
the proposed research are invited to work with their institutions to develop
an application for support. Individuals from underrepresented racial and
ethnic groups as well as individuals with disabilities are always encouraged
to apply for NIOSH programs.
Note: Title 2 United States Code section 1611 states that an organization
described in section 501(c)(4) of the Internal Revenue Code that engages in
lobbying activities is not eligible to receive Federal funds constituting an
award, grant, or loan.
SPECIAL REQUIREMENTS
The essential characteristics of a Mining Safety and Health Training and
Translations Research Center are:
1. Administrative, Planning and Outreach Core.
2. Training Projects.
3. Translation Projects
ESSENTIAL ELEMENTS OF A WESTERN TRAINING AND TRANSLATION CENTER
ADMINISTRATIVE AND PLANNING CORE
The Administrative, Planning and Outreach Core must have a leader who is
capable of providing training and translation research leadership for the
administration and integration of the program. Assessment of the ability of
the program’s principal investigator to lead a highly integrated program of
training and translation projects will be a significant consideration in the
evaluation of the application.
The Administrative, Planning and Outreach Core is intended to support the
administrative infrastructure for the entire program and should not be
duplicated within any other components. The responsibilities and activities
for this core include:
o Appropriate and adequate organization and facilities for activities such
as seminars, workshops, reference collection, computer support, etc. The
principal investigator should provide a minimum of 10% time commitment
(direct and in-kind) for the Mining Center’s administration and coordination.
o An External Advisory Committee, comprised of at least three members who
are recognized leaders in mining health and safety and regional mining
experts, will provide overall guidance and advice to the principal
investigator on program direction.
o Outreach Activities: Essential functions of the outreach core include but
are not limited to, coordinating and collaborating with mining researchers
and industry stakeholders to identify key issues and needs. The principal
investigator may also include ongoing mining communication efforts and
convening consensus-development sessions to address complex and/or
controversial issues with the aim of preventing mining injuries and illness.
o First year funds for program initiation. NIOSH recognizes that there may
be significant costs associated with the initiation of a Western States
Training Program. Therefore, in the first year of the project an
investigator may include up to $200,000 in direct costs for startup expenses.
Items that may be appropriate for these funds include computer work stations,
classroom modifications/supplies, web site development, distance learning
equipment, etc. The request for these funds must be well justified in the
application.
TRAINING PROJECTS
This should be the major focus of the program. These projects should focus
on the training of Western miners. The activities should be well described
and sufficient details provided to enable a peer review panel to assess the
quality of the proposed training. A well defined evaluation component is
considered an essential element for the training projects.
The recipient should coordinate project activities, academically,
scientifically and administratively, at the awarded institution and at the
other sites that may be supported by sub-contractors to this award. The
applicant will have primary authority and responsibility to define objectives
and approaches; to identify and train the target populations; to plan and
conduct a Western program for mine safety and health training, to analyze and
evaluate the training impact; and to publish results, interpretations, and
conclusions of activities conducted.
TRANSLATION PROJECTS
(These projects CANNOT exceed $250,000 in direct cost in the first year, and
$200,000 in direct costs in the out years. Applications exceeding $250,000 in
direct costs for translation projects in the first year or $200,000 in the
subsequent years will be considered unresponsive and returned without further
consideration.)
These are projects that focus on the translation of extant knowledge (e.g.
peer reviewed articles) into products or practices that meet mining
customer needs so as to maximize the impact on industry practices. The
Principal Investigator (Center Director) should view these projects as the
tool to move results from the research environment into the mining industry.
As the goal for these projects is the adoption of new/improved knowledge in
the mining sector, the principal investigator must include in the project
plan how the study will accomplish this goal.
Translation projects may include but are not limited to technology transfer
projects or demonstration projects that expand the use of effective
interventions by a mining trade or industry group. Projects may address
research issues that affect the diffusion of results to the work setting.
Such research could include projects to improve understanding of what
influences mining industry decision-makers, workers, contractors, or others
to adopt new practices, tools, and methods to improve safety and health
performance.
PROJECT PLANS
Special instructions for defining project plans are included in the public
health service grant guidelines (PHS 398, page 15) and should address the
following questions 1) What do you intend to do to address the problem, 2)
Why is the work important, 3)What has already been done to address this need,
and 4)How are you going to do the work to address the needs of the program.
Items a-d should be organized to address these questions in detail.
a. Specific Aims: Identify the broad, long-term objectives of the proposed
training and translation projects and expected accomplishments.
b. Background and Significance: Briefly provide relevant background
information related to the project; include a critique of existing training
programs for mining workers. Identify training gaps that the proposed project
will address. Describe the need for a comprehensive Western United States
Mining training program and how this project will satisfy this need.
Describe the needs for translational projects.
c. Preliminary Studies: Preliminary studies/activities conducted by the
principal investigator/program director should be included to establish past
experience and competence in the project area. Include a list of appropriate
publications and training materials.
d. Project Design and Methods: Describe in detail the project design and
methods that will be used to achieve the objectives of the project, the steps
to be undertaken in planning, implementing and evaluating this project, and
the respective responsibilities of the applicant and other personnel for
carrying out those steps. The project design and methods should specifically
address how the goals of the program will be met to include 1) assessing the
needs for the Western training program, 2) developing and conducting a five
year training and translation project plan to meet those needs, 3) providing
qualified instructors and faculty to train mining personnel, 4) evaluating
the training program and the impact on mining safety and health, and 5) fully
describing the translation project.
A schedule for accomplishing each of the tasks to be carried out during the
project period (include a time-line for activities) and a method for
evaluating the accomplishments should be provided. In addition, describe the
names and qualifications of the proposed staff and time allocated for them to
accomplish program activities; the support staff available for the project;
the instructors for the program; and audio-visual support, the facilities,
space, and equipment available for the project.
Letters of support from professional/community organizations, agencies and
worker groups whose participation is essential for program success (such as
mining groups, potential trainees, etc.) should be included. Submit a plan
for evaluating the Western training program and its impact on mining safety
and health, including tracking trainee activities.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants management
issues. This RFA and other CDC Announcements can be found on the CDC
HomePage at http://www.cdc.gov, under the Funding Section (see Grants and
Cooperative Agreements, scroll down to Occupational Safety and Health). This
RFA can also be found on the NIOSH HomePage
http://www.cdc.gov/niosh/homepage.html, under Funding Opportunities.
Direct your questions about scientific/research issues to:
Michael J. Galvin Jr., Ph.D.
Scientific Program Administrator
Office of Extramural Programs
Centers for Disease Control and Prevention
National Institute for Occupational Safety and Health
1600 Clifton Road, N.E.
Building 24, Room 1536, MS E-74
Atlanta, GA 30333
Telephone: (404) 498-2524
FAX: (404) 498-2571
Email: [email protected]
Direct your questions about peer review issues to:
Pervis C. Major, Ph.D.
Scientific Review Administrator
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention (CDC)
1095 Willowdale Rd
Morgantown, WV 26505
Telephone 304-285-5979
Fax 304-285-6147
Email: [email protected]
Direct inquiries about financial or grants management matters to:
Mr. John Columbia, Contract Specialist
Acquisition and Assistance Field Branch
Centers for Disease Control and Prevention
626 Cochrans Mill Road
Pittsburgh, Pennsylvania 15236-0070
Telephone: (412) 386-4458
Email: [email protected]
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does not
enter into the review of an application, the information that it contains is
used to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed at the beginning of
this document and should be sent to:
Pervis C. Major, Ph.D.
Scientific Review Administrator
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention (CDC)
1095 Willowdale Rd
Morgantown, WV 26505
Telephone 304-285-5979
Fax 304-285-6147
Email: [email protected]
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). Applications must have a DUN and
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the
Universal Identifier when applying for Federal grants or cooperative
agreements. The DUNS number can be obtained by calling (866) 705-5711 or
through the web site at http://www.dunandbradstreet.com/. The DUNS number
should be entered on line 11 of the face page of the PHS 398 form. The PHS
398 document is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: [email protected].
SUPPLEMENTARY INSTRUCTIONS:
All projects (education or translation), should be consistent with the
competitive/peer-reviewed applications that are typically awarded by NIOSH
and NIH and adhere to the submission guidelines for a R01/R21/R03 application
following the PHS 398 application instructions. The R01 is an investigator
initiated project that can request up to 5 years of support. The R21 and R03
is for projects that are short-term in nature or for pilot projects.
PHS 398 form page 3 contains the section entitled Research Plan and
although some projects are not hypothesis based research, this section should
be used to describe the specific aims, background and significance,
preliminary information or data, the project approach, for each project
(education or translation). This section should contain sufficient
information to address the project’s goals and plan to achieve those goals,
and should answer the following questions; 1) What do you intend to do?, 2)
Why is the work important?, 3) What has already been done?, and 4) How are
you going to do the work (see page 15 of the 398 instructions for additional
guidance).
Each project type section should begin with a cover sheet that identifies it
as the beginning of the project section (administrative core, education
project, translation project). The name of a project investigator who will be
a member of the internal advisory committee should be listed. This page is
then followed by as many subsections as there are projects under that type.
Each subsection begins with a header page that identifies the project
investigator and title of the project. The next page is the form page 2 of
the PHS 398 which provides the description, performance sites, and key
personnel. For further instructions refer to Table of Contents for a Mining
Center Application , provided below.
For each R01-type project, the project application should not exceed 25 pages
for items d - g for education or translation project (see the, Table of
Contents for a Mining Center Application). For short term (two years in
duration, R21/03-type) projects, follow the instructions for a NIOSH
Exploratory/Developmental grant (R21), see NIH guide:
http://grants.nih.gov/grants/guide/pa-files/PA-04-030.html or for a R03 type
project see NIH guide:
http://grants.nih.gov/grants/guide/pa-files/PA-04-021.html .
The page limits for items d - g should be followed for the R21 (15
pages) and R03 type projects (10 pages). Refer to Table of Contents for a
Mining Center Application , provided below.
The budget information, other support, etc. should be included in the
appropriate sections of the application.
NOTE: NIOSH will inform successful applicants of the procedures for
translation and education projects in future years of support. Thus, the
application should contain only projects for which funds are requested for
support during year one.
TABLE OF CONTENTS FOR A MINING CENTER APPLICATION
In order to facilitate the preparation and review of the Mining Center
application, the following Table of Contents should be used. It is a minor
modification of the PHS 398 Table of Contents which should be followed as a
guide.
o Face Page
o Mining Center Description, Performance Sites, and Personnel, Form page
2(use additional continuation pages as needed)
o Table of Contents
o Detailed Budget for the Initial Budget Period for the entire Mining Center
o Budget for the Entire Proposed Period of Support for the Entire Mining
Center
o Detailed Budget for each Project for the Initial Budget Period Organized by
category: Administrative Core, Education and Translation Projects
o Budget for the Entire Proposed Period for each Project Organized by
Category
o Biographical Sketch-Principal Investigator/Program Director
o Other Biographical Sketches
o Other Support
o Overall Description of the Mining Center (2 page maximum)
o Past Performance/Accomplishments in Last Project Period (existing Mining
Center)
o Past Performance/Accomplishments Relevant to Mining Center goals (new
applicants)
o Statement on the Institutional Commitment to the Mining Center (1 page
maximum)
o Human Subjects summary table that lists all the projects and human subjects
information (title, performance sites, FWAs, IRB approval date/status)
o Administrative and Planning Core Cover Sheet
o Administrative and Planning Core
o Education Project Cover Sheet
o Education Project A (use as many headings as there are projects)
o Translation Project Cover Sheet
o Translation Project Plan A (use as many headings as there are projects)
Note: each project plan should use the following outline
a. Header Page with Title, Principal Investigator's name, and type of
project (comprehensive or pilot)
b. Description, Performance Sites, and Personnel (form page 2)
c. Highlights of Accomplishments for Past Project Period if it was part of
an existing Mining Center (1 page maximum)
d. Specific Aims
e. Background and Significance
f. Preliminary Studies/Progress Report
g. Project Design and Methods
Items d-g cannot exceed 25 pages (except R03/R21 type projects which cannot
exceed 10/15 pages respectively)
h. Human Subjects
i. Vertebrate Animals
j. Literature Cited
k. Consortium/Contractual Arrangements
l. Consultants and Collaborators, including NIOSH/CDC
If the proposed project involves organizations or persons other than those
affiliated with the applicant organization, letters of support and/or
cooperation must be included.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001)
application form must be affixed to the bottom of the face page of the
application. Type the RFA number on the label. Failure to use this label
could result in delayed processing of the application such that it may not
reach the review committee in time for review. In addition, the RFA title
and number must be typed on line 2 of the face page of the application form
and the YES box must be marked. The RFA label is also available at:
http://grants.nih.gov/grants/funding/phs398/labels.pdf
SENDING AN APPLICATION TO THE NIOSH: Submit a signed, typewritten original of
the application, including the Checklist, and three signed photocopies, in
one package to:
Center for Scientific Review (CSR)
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application and all
copies of appendix material must also be sent to:
Price Connor, Ph.D.
Lead Scientific Review Administrator
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road, N.E.
Building 24, Room 1618, MS E-74
Atlanta, GA 30333
Telephone (404) 498-2511
Fax (404) 498-2571
Email: [email protected]
APPLICATION PROCESSING: Applications must be received by the application
receipt date listed in the heading of the RFA. If an application is received
after that date, it will be returned to the applicant without review.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and funding
assignment within eight weeks.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by CSR and
responsiveness by NIOSH. Incomplete and/or nornresponsive applications will
be returned to the applicant without further consideration.
Applications that are complete and responsive to the RFA will be evaluated
for scientific and technical merit by a scientific review group convened by
NIOSH in accordance with the review criteria stated below. As part of the
initial merit review, all applications will:
o Undergo a process in which only those applicants deemed to have the highest
scientific or technical merit, generally the top half of the applications
under review, will be discussed and assigned a priority score
o Receive a written critique.
o Receive a second level of review by the NIOSH Secondary Review Committee.
REVIEW CRITERIA
The criteria that NIOSH will use to review applications for scientific merit
and for meeting program objectives are provided below. In the written
comments, reviewers will be asked to discuss the following aspects of the
application in order to judge the likelihood that the proposed research will
have a substantial impact on the pursuit of these goals. The scientific
review group will address and consider each of these criteria in assigning
the application’s overall score, weighting them as appropriate for each
application.
o Significance
o Approach
o Innovation
o Investigator
o Environment
The application does not need to be strong in all categories to be judged
likely to have major scientific impact and thus deserve a high priority
score. For example it may propose to carry out important work that by its
nature is not innovative but essential to move a field forward.
SIGNIFICANCE:
If the aims of the application are achieved, how will knowledge be advanced?
Will the proposed project contribute to the overall aims of improving mine
safety and health?
o Did the applicant communicate the needs and objectives of providing a
comprehensive Western United States training program for miners?
o Is the application responsive and relevant to the objectives outlined in
the RFA? Have the broad, long-term objectives of the project and expected
accomplishments been defined?
o Did the applicant provide a needs assessment for training for Western
United States miners to identify specific areas of training needed?
o Did the applicant provide a strong rationale for the translation
project(s)?
APPROACH:
o Does the project identify and target necessary personnel to be trained,
including the types of trainees, amount of training, and specific levels of
training?
o Does the applicant provide a detailed and well conceived plan for the
translation project(s)?
o Does the application provide a detailed plan (project design and methods)
and a proposed schedule for accomplishing each of the activities to be
carried out in this project?
o Does the project provide a plan to conduct training programs for mine
workers?
o Does the project meet current OSHA or MSHA guidelines and other
recommendations for training mine workers?
o Does the application clearly define the strengths, limitations, and
comprehensiveness of the Western training program plan to address the
distinct characteristics and needs of the target audience, including the
essential program elements for planning, conducting, and evaluating training
programs?
o Does the project provide a mechanism to evaluate the knowledge and skills
of miners before and after training in order to ensure consistency in
delivering training programs for target worker populations?
o Are the proposed training materials and personnel adequate for
accomplishing the proposed activities?
o Is the time-line proposed for the project suitable?
o Is there a method for evaluating the knowledge, the effectiveness of
training, and impact of the training on mine workers?
INNOVATION:
o Does the applicant propose innovative concepts, approaches, or methods for
training mine workers?
o Does the applicant propose innovative concepts, approaches, methods for
establishing a five year Western training program, including collaboration
with the mining communities?
INVESTIGATOR:
o Does the training and experience of the Program Director and staff meet the
needs of the proposed project?
o Does the training personnel have appropriate expertise in the mining field
and experience in developing curricula?
o Is the investigator(s) for the translation project(s) qualified and
appropriate?
o Are the proposed course materials current?
o Does the project provide a method for selecting and training faculty to
conduct training classes?
ENVIRONMENT:
o Are the applicant’s facilities, equipment, and other resources adequate for
the performance of this project?
o Is there evidence of institutional support or other documentation that
demonstrated the applicant’s ability to work with diverse groups, establish
collaborations, and facilitate emergency response information?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following
items will be considered in the determination of scientific merit and the
priority score:
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human
subjects and protections from research risk relating to their participation
in the proposed research will be assessed. (See criteria included in the
section on Federal Citations, below).
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of
plans to include subjects from both genders, all racial and ethnic groups
(and subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria in the sections on
Federal Citations, below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to
be used in the project, the five items described under Section f of the PHS
398 research grant application instructions (rev. 5/2001) will be assessed.
ADDITIONAL REVIEW CONSIDERATIONS
o BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
PROGRAMMATIC REVIEW CRITERIA
o Number of mining personnel to be trained.
o Appropriateness of the target population.
o The likelihood of mining personnel and trainees developing technical
knowledge for the prevention of injury or disease from mining operations.
o The likelihood of the translation projects impacting the mining
environment.
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit
o Availability of funds
o Programmatic priorities
o Population studied
REQUIRED FEDERAL CITATIONS
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and
others, and the importance of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II), efficacy,
effectiveness and comparative trials (phase III). The establishment of data
and safety monitoring boards (DSMBs) is required for multi-site clinical
trials involving interventions that entail potential risk to the
participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for
Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date,
investigators submitting an NIOSH application will follow the NIH policy.
Applicants seeking $500,000 or more in direct costs in any single year are
expected to include a plan for data sharing or state why this is not
possible. http://grants.nih.gov/grants/policy/data_sharing
Investigators should seek guidance from their institutions, on issues related
to institutional policies, local IRB rules, as well as local, state and
Federal laws and regulations, including the Privacy Rule. Reviewers will
consider the data sharing plan but will not factor the plan into the
determination of the scientific merit or the priority score.
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of
the NIOSH and NIH that women and members of minority groups and their sub-
populations must be included in all NIOSH-supported clinical research
projects unless a clear and compelling justification is provided indicating
that inclusion is inappropriate with respect to the health of the subjects or
the purpose of the research. This policy results from the NIH Revitalization
Act of 1993 (Section 492B of Public Law 103-43).
All investigators proposing clinical research should read the "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research -
Amended, October, 2001," published in the NIH Guide for Grants and Contracts
on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable;
and b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all human subjects research, conducted or supported
by the NIH, unless there are scientific and ethical reasons not to include
them. This policy applies to all initial (Type 1) applications submitted for
receipt dates after October 1, 1998. NIOSH has adopted this policy
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as participants in
research involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH proposals for research involving human
subjects. You will find this policy announcement in the NIH Guide for Grants
and Contracts Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. NIOSH
has adopted this policy.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2)
cited publicly and officially by a Federal agency in support of an action
that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this PA/RFA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the
application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The
Department of Health and Human Services (DHHS) issued final modification to
the Standards for Privacy of Individually Identifiable Health Information ,
the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal
regulation under the Health Insurance Portability and Accountability Act
(HIPAA) of 1996 that governs the protection of individually identifiable
health information, and is administered and enforced by the DHHS Office for
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified
under the Rule as covered entities ) must do so by April 14, 2003 (with the
exception of small health plans which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule reside
with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including
a complete Regulation Text and a set of decision tools on Am I a covered
entity? Information on the impact of the HIPAA Privacy Rule on NIH
processes involving the review, funding, and progress monitoring of grants,
cooperative agreements, and research contracts can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs IN NIOSH GRANT APPLICATIONS OR APPENDICES: All applications and
proposals for NIOSH funding must be self-contained within specified page
limitations. Unless otherwise specified in an NIOSH solicitation, Internet
addresses (URLs) should not be used to provide information necessary to the
review because reviewers are under no obligation to view the Internet sites.
Furthermore, we caution reviewers that their anonymity may be compromised
when they directly access an Internet site.
LOBBYING RESTRICTIONS: Applicants should be aware of restrictions on the use
of Health and Human Services (DHHS) funds for lobbying of Federal or State
legislative bodies. Under the provisions of 31 U.S.C. Section 1352,
recipients (and their subtier contractors) are prohibited from using
appropriated Federal funds (other than profits from a Federal contract) for
lobbying congress or any Federal agency in connection with the award of a
particular contract, grant, cooperative agreement, or loan. This includes
grants/cooperative agreements that, in whole or in part, involve conferences
for which Federal funds cannot be used directly or indirectly to encourage
participants to lobby or to instruct participants on how to lobby.
In addition, no part of the Centers for Disease Control and Prevention (CDC)
appropriated funds shall be used, other than for normal and recognized
executive-legislative relationships, for publicity or propaganda purposes,
for the preparation, distribution, or use of any kit, pamphlet, booklet,
publication, radio, television, or video presentation designed to support or
defeat legislation pending before the Congress or any State or local
legislature, except in presentation to the Congress or any State or local
legislature itself. No part of the appropriated funds shall be used to pay
the salary or expenses of any grant or contract recipient, or agent acting
for such recipient, related to any activity designed to influence legislation
or appropriations pending before the Congress or any State or local
legislature.
Any activity designed to influence action in regard to a particular piece of
pending legislation would be considered lobbying. That is lobbying for or
against pending legislation, as well as indirect or grass roots: lobbying
efforts by award recipients that are directed at inducing members of the
public to contact their elected representatives at the Federal or State
levels to urge support of, or opposition to, pending legislative proposals is
prohibited. As a matter of policy, CDC extends the prohibitions to lobbying
with respect to local legislation and local legislative bodies.
The provisions are not intended to prohibit all interaction with the
legislative branch, or to prohibit educational efforts pertaining to public
health. Clearly there are circumstances when it is advisable and permissible
to provide information to the legislative branch in order to foster
implementation of prevention strategies to promote public health. However,
it would not be permissible to influence, directly or indirectly, a specific
piece of pending legislation.
It remains permissible to use CDC funds to engage in activity to enhance
prevention; collect and analyze data; publish and disseminate results of
research and surveillance data; implement prevention strategies; conduct
community outreach services; provide leadership and training; and foster safe
and healthful environments.
Recipients of CDC grants and cooperative agreements need to be careful to
prevent CDC funds from being used to influence or promote pending
legislation. With respect to conferences, public events, publication, and
grassroots activities that relate to specific legislation, recipients of
CDC funds should give attention to isolating and separating the appropriate
use of CDC funds from non-CDC funds. CDC also cautions recipients of CDC
funds to be careful not to give the appearance that CDC funds are being used
to carry out activities in a manner that is prohibited under Federal law.
HEALTHY PEOPLE 2010: The CDC is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2010," a national
activity for reducing morbidity and mortality and improving the quality of
life. This RFA is related to one or more focus areas. Potential applicants
may obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under the authorization of Sections
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284)
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All
awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The NIH Grants
Policy Statement can be found at
http://grants.nih.gov/grants/policy/policy.htm.
SMOKE FREE WORKPLACE: The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco
products. In addition, Public Law 103-227, the Pro-Children Act of 1994,
prohibits smoking in certain facilities (or in some cases, any portion of a
facility) in which regular or routine education, library, day care, health
care, or early childhood development services are provided to children. This
is consistent with the PHS mission to protect and advance the physical and
mental health of the American people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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