MINING SAFETY AND HEALTH TRAINING AND TRANSLATION CENTER

RELEASE DATE:  November 20, 2003

RFA Number:  RFA-OH-04-005 

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATIONS:  
Centers for Disease Control and Prevention (CDC)

PARTICIPATING INSTITUTES AND CENTERS: 
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:  December 18, 2003
APPLICATION RECEIPT DATE:  January 23, 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 July 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 $600,000.  Applications 
exceeding $1,000,000 in total costs in the first year or $600,000 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 Core.  
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 $200,000 in direct cost in the first year, and 
$100,000 in direct costs in the out years. Applications exceeding $200,000 in 
direct costs for translation projects in the first year or $100,000 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: mtg3@cdc.gov

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: pmajor@cdc.gov 

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: JColumbia@cdc.gov

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: pmajor@cdc.gov 

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) 435-0714, 
Email: GrantsInfo@nih.gov.

SUPPLEMENTARY INSTRUCTIONS:

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:

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: pmajor@cdc.gov 

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 nonresponsive 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:

o Significance
o Approach
o Innovation
o Investigator
o Environment

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.  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.


Return to Volume Index

Return to NIH Guide Main Index


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.