COLLABORATIVE PROGRAM FOR THE IDENTIFICATION AND PREVENTION OF WORK-RELATED 
MUSCULOSKELETAL DISORDERS

RELEASE DATE:  April 7, 2003

RFA: OH-03-006

Department of Health and Human Services, 
Centers for Disease Control and Prevention (CDC), 
National Institute for Occupational Safety and Health (NIOSH)
 (http://www.cdc.gov/niosh/homepage.html)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.262 

LETTER OF INTENT RECEIPT DATE: May 20, 2003 
APPLICATION RECEIPT DATE: June 12, 2003

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 Special Requirements
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

The National Institute for Occupational Safety and Health (NIOSH) invites 
applications for a Cooperative Agreement (U01) from single institutions or 
consortia of institutions which are capable of, and interested in, 
participating in a Musculoskeletal Disorders Consortium (MSDC).  The goal of 
the MSDC is to coordinate a prospective cohort study to quantify the risk of 
upper limb and low back musculoskeletal disorders at varying levels of 
exposure to physical job stressors (repetitive motion, forceful exertions, 
awkward postures, manual handling, etc.).  This research will involve multiple 
work sites from the service and manufacturing industries with job tasks that 
represent a range of exposures to physical job stressors that can result in 
musculoskeletal disorders.  Under this RFA, one new extramural partner that 
demonstrates expertise in the evaluation of exposure response between low back 
disorders and the physical demands of lifting and manual handling tasks will 
be awarded a cooperative agreement and will participate in the MSDC.  

RESEARCH OBJECTIVES

Background

Work-related Musculoskeletal Disorders (MSDs) remain a large and costly 
disease to our society even though there have been many advances in 
understanding the ergonomics of work.  For 1996, the Bureau of Labor 
Statistics (BLS) reported that a total of 600,390 work-related musculoskeletal 
injury cases resulting in work absence or restriction were caused by 
overexertion and repetitive motion.  Because the BLS annual survey does not 
cover approximately one-third of workers, this figure significantly 
underestimates the overall incidence of MSDs in the American workforce.  Of 
all MSD cases, sixty-nine percent were low back or distal upper limb 
disorders.  The magnitude of the problem in today's workforce is confirmed by 
workers' compensation data.  For instance, in Washington State between 1990 
and 1997, 27 percent of all workers' compensation claims and 46 percent of the 
cost of all claims resulted from non-traumatic musculoskeletal disorders of 
the neck, upper extremity or back.  The results from this research program 
will provide practitioners in occupational health critical data that will 
facilitate their identification of job tasks that represent low, moderate and 
high risk for MSDs and that will provide a knowledge base for effective job 
design changes or interventions.  Because of the limitations of cross-
sectional and retrospective studies, it is widely agreed that a prospective 
cohort study design is the best approach for this problem.

This RFA builds on an initial effort in 2000 to begin a Collaborative Program 
for the Identification and Prevention of Work-related Musculoskeletal 
Disorders (see http://grants.nih.gov/grants/guide/rfa-files/rfa-OH-00-
003.html).  As a result of the initial RFA, awards were made to evaluate 
exposure response relationships between physical stressors and upper extremity 
and low back musculoskeletal disorders.  A second RFA in 2002 expanded this 
program by awarding an additional cooperative agreement to evaluate upper 
extremity disorders (see http://grants.nih.gov/grants/guide/rfa-files/RFA-OH
-02-010.html).  The current RFA is focused on providing an additional award 
to expand the research effort on low back disorders in relation to varying 
levels of physical demand due to lifting and manual material handling.  An 
integral part of this initiative is participation in a Musculoskeletal Disorders 
Consortium (MSDC).  In order to achieve the goals of this program, it is 
important to have shared data elements among awardees that are managed in a 
uniform and compatible format.  In addition, because much of the shared data 
elements are centered on job tasks and workers, a critical role of the MSDC is 
to assure that job tasks are studied using uniform exposure assessment methods 
and health assessment methods to identify MSDs.  In order to accomplish that 
goal, the initial awardees established a Coordination Committee (CC), to serve 
as the main governing board for the conduct of this research program.  The CC 
is comprised of one voting representative from each member of the consortium. 
The new awardee under this current RFA will also be a voting member on the CC. 
The CC will continue to serve as an advisory body for the common or shared 
protocols to be used in the studies.  NIOSH staff serves as non-voting members 
of the CC.

Goals

An important goal of this research program is to better define exposure-
response relationships between job physical stressors and musculoskeletal 
disorders across manufacturing and service industries.  Information regarding 
the utility of practical methods that could be readily employed by 
occupational safety and health practitioners, such as the NIOSH Lifting 
Equation and the American Conference of Governmental Industrial Hygienists 
Threshold Limit Value for Hand Activity, is another anticipated outcome.  In 
addition, it is anticipated that practitioners in occupational health will be 
able to use the results from this study to more quickly and reliably 
discriminate job tasks that represent low, moderate and high risk for 
musculoskeletal disorders.  With such knowledge effective job design changes 
or interventions can be developed that reduce the burden of work-related 
musculoskeletal disorders.  

In summary, the intent of the initial RFA (RFA: OH-00-003) was to assemble a 
cross-disciplinary, multi-institutional consortium to define exposure response 
relationships among physical job stressors and upper limb and low back MSDs.  
Three Cooperative agreements were awarded, one focused on upper extremity 
disorders, one focused on low back disorders and the third focused on hand-arm 
vibration.  As a result of a second RFA (RFA: OH-02-010), one cooperative 
agreement was awarded that focused on upper extremity disorders.  The intent 
of the current RFA is to support additional research that is focused on low 
back disorders in relation to multiple levels of physical demands related to 
lifting and manual handling tasks in the manufacturing or service industry.

USEFUL REFERENCES

National Institute for Occupational Safety and Health.  National Occupational 
Research Agenda. Cincinnati, OH: U.S. Department of Health and Human Services, 
Public Health Service, Centers for Disease Control and Prevention, National 
Institute for Occupational Safety and Health, DHHS (NIOSH) Publication 
No.96-115 (http://www.cdc.gov/niosh/nora.html). 

MECHANISM OF SUPPORT

This RFA will use NIH U01 award mechanism(s).  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 30, 
2003.  Applications that are not funded in the competition described in this 
RFA may be resubmitted as NEW investigator-initiated applications using the 
standard receipt dates for NEW applications described in the instructions to 
the PHS 398 application.  

This RFA uses just-in-time concepts.  It also uses the modular as well as the 
non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  Specifically, if 
you are submitting an application with direct costs in each year of $250,000 
or less, use the modular format.  Otherwise follow the instructions for non-
modular research grant applications.  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. 

The NIH (U01) is a cooperative agreement award mechanism in which the 
Principal Investigator retains the primary responsibility and dominant role 
for planning, directing, and executing the proposed project, with NIH staff 
being substantially involved as a partner with the Principal Investigator, as 
described under the section "Cooperative Agreement Terms and Conditions of 
Award".

FUNDS AVAILABLE

NIOSH intends to commit approximately $500,000 in FY 2003 to fund one new 
cooperative agreement award in response to this RFA.  If additional monies 
become available, an additional award may be made. An applicant may request a 
project period of up to three years and a budget for total costs (direct and 
indirect) up to $500,000 per year. Because the nature and scope of the 
proposed research will vary from application to application, it is anticipated 
that the size and duration of each award will also vary. 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. 

Applicants should allocate funds for travel for two project staff to attend 
two CC meetings held during each project year.

ELIGIBLE INSTITUTIONS

You may submit (an) application (s) if your institution 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 Domestic or foreign
o Faith-based or community-based organizations

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.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed program is invited to work with their institution 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/CDC programs.

SPECIAL REQUIREMENTS

Applicants with established resources and facilities to recruit study sites 
and to enroll workers willing to participate in the study in a cost effective 
manner are encouraged.

The following should be addressed in a clear and organized manner (see also 
peer review criteria section):

o Timeline: a detailed timeline for the proposed study must be included in the 
application.

o In a separate section labeled ,"Participant Notification of Study Results", 
the applicant should describe plans for notifying participants about their 
individual results and the overall results of the study. 

o Plan for sharing data with other members of the MSDC and using uniform 
exposure assessment methods and health assessment methods to identify MSDs.

Applicants should highlight unique expertise and/or unusual opportunities as 
related to the purpose of this RFA.  Examples include, but are not limited to: 

o Expertise in specialized areas with potential applications to the 
issues/questions considered in this RFA, conducting epidemiologic field 
studies of working populations, experience in exposure assessment using 
practical field methods such as the NIOSH lifting equation; and collection of 
health outcome data at the workplace;

o Access to specific work sites and working populations that are willing to 
participate in studies of work-related low back disorders;

o Expertise in assessing work situations and individual job tasks in relation 
to the development of work-related low back disorders; and/or

o Expertise in negotiating with work site management in field settings.

Coordination Committee and Annual MSDC Meetings

Applicants should include in their budget support for themselves and for at 
least one other person from their institutions integrally involved in the 
project to attend two Coordination Committee (CC) meetings of the MSDC each 
year.  For budget preparation and project planning purposes, it should be 
assumed that these meetings will be of one or two days duration and will be 
held in Cincinnati, Ohio.  The CC will determine later where and when 
recurring CC meetings will be held.  The CC chair will coordinate the meetings 
to review and assess overall progress and provide the opportunity for 
investigators to exchange information and discuss research issues.

Cooperative Agreement Terms and Conditions of Award

The Terms and Conditions of Award, below, will be incorporated in the award 
issued as a result of this RFA.  It is critical that each applicant include 
specific plans for responding to these terms.  These special Terms of Award 
are in addition to and not in lieu of otherwise applicable OMB administrative 
guidelines and HHS Grant Administration Regulations at 45 CFR Parts 74 and 92. 
The administrative and funding instrument used for this program is a 
cooperative agreement (U01), an "assistance" mechanism (rather than an 
"acquisition" mechanism) in which substantial NIOSH scientific and/or 
programmatic involvement with the awardee is anticipated during performance of 
the activity.

Under the cooperative agreement, the NIOSH purpose is to support and/or 
stimulate the recipient's activity by involvement in and otherwise working 
jointly with the award recipient in a partner role, but it is not to assume 
direction, prime responsibility, or a dominant role in the activity.  
Consistent with this concept, the dominant role and prime responsibility for 
the activity resides with the awardee(s) for the project as a whole, although 
specific tasks and activities in carrying out the studies will be shared among 
the awardees and the NIOSH collaborators where appropriate, including the 
following:

1.  Recipient Responsibilities
The recipient will coordinate project activities, scientifically and 
administratively at the awardee 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 plan, 
conduct, and analyze data; and to publish results, interpretations, and 
conclusions of studies conducted under the terms and conditions of the 
cooperative agreement award.  In addition, the applicant is responsible for 
coordination of the individual study with the CC.  It is anticipated that 
recipients will utilize common approaches as agreed upon by the CC so that 
data can be combined.  Recipient will:

a.  Enroll and follow the study participants and establish and maintain 
mechanisms to ensure that data collection and management procedures have 
necessary quality control and assure confidentiality of data.

b. Serve as a permanent member of the CC. 

c. Develop and submit semiannual progress reports in a standard format that is 
agreed upon after an award is made. 

d. Provide program management oversight for the project. 

e. Notify study participants of the overall study results. 

2.  NIOSH Staff Responsibilities

NIOSH will have substantial scientific programmatic involvement during conduct 
of this activity, through technical assistance, advice, and coordination.

a. Serve as a scientific liaison between the awardee and other program staff 
at NIOSH with experience in the occupational health issues of MSDs and 
epidemiology.

b. Provide expert consultation in the area of occupational epidemiology.

c. Provide technical advice on monitoring of field data collection, developing 
operating guidelines, quality control procedures, and developing 
policies/protocols for dealing with recurrent situations. 

d. Facilitate collaborative efforts to compile and disseminate program results 
through presentations and publications.

e. Assist in the development of human subjects protocols for the CDC 
Institutional Review Board (if required) and in the preparation of OMB (and 
other) clearances that may be required during the conduct of the study. 

3.  Collaborative Responsibilities

The Coordination Committee will serve as the main governing board for the 
cooperative agreements making up the MSDC.  NIOSH scientists and one external 
scientist from each award will have membership on the Coordination Committee.
One critical role of the CC is to ensure that the study designs and data 
collection protocols are uniform and compatible across the MSDC.   

The Coordination Committee may invite, when it deems it to be necessary, 
additional, non-voting scientific advisors to the meetings at which research 
priorities and opportunities are discussed.

It is anticipated that there will be two Coordination Committee meetings each 
year.  Locations of the meetings will be determined by the CC.  The committee 
chair (NIOSH representatives will not serve in this position) will schedule 
the meetings and will be responsible for developing the meeting agenda, 
chairing the meetings, and producing CC reports. 

At the Coordination Committee meetings, the Coordination Committee will: 1) 
make recommendations on the study protocols and data collection approaches, 2) 
discuss the study populations that have been/will be recruited, 3) identify 
and recommend solutions to unexpected study problems and 4) discuss ways to 
efficiently coordinate and combine common study activities.  These 
recommendations will be of direct benefit to the awardees by improving the 
scientific quality and comparability of their research.

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into two 
areas: scientific/research, peer review and financial or grants management 
issues.  This RFA and other CDC Announcements can be found on the CDC HomePage 
(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) under 
"Extramural Programs", "Current Funding Opportunities".

Direct inquiries regarding programmatic issues to:

Lee M. Sanderson, Ph.D.
Scientific Program Administrator
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road, N.E.
Executive Park Building 24, Room 1429, MS E-74
Atlanta, GA  30333
Telephone: (404) 498-2546
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
1095 Willowdale Road
Morgantown, WV 26505
Telephone: 304-285-5979
Fax: 304-285-6147
Email:  [email protected]

Direct inquiries regarding grants management business matters to:

Larry Guess
Acting Chief
Acquisition and Assistance Field Branch
Centers for Disease Control and Prevention 
626 Cochrans Mill Road
Pittsburgh, Pennsylvania 15236-0070
Announcement Number OH-03-006
Telephone: (412) 386-6826
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 should be sent to by the date listed at the beginning of 
the document. The letter of intent 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
1095 Willowdale Road
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).  The PHS 398 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]. Information to prepare a detailed budget is 
provided in the 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.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting 
up to $250,000 per year in direct costs must be submitted in a modular grant 
format.  The modular grant format simplifies the preparation of the budget in 
these applications by limiting the level of budgetary detail.  Applicants 
request direct costs in $25,000 modules.  Section C of the research grant 
application instructions for the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular grants.  Additional information on modular 
grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

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 NIH: 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 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
1095 Willowdale Road
Morgantown, WV 26505
Telephone 304-285-5979
Fax 304-285-6147              
Email: [email protected]

APPLICATION PROCESSING: Applications must be received on or before the 
application receipt date listed in the heading of this 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 8 weeks. 

The Center for Scientific Review (CSR) and NIOSH will not accept any 
application in response to this RFA that is essentially the same as one 
currently pending initial review, unless the applicant withdraws the pending 
application.  However, when a previously unfunded application, originally 
submitted as an investigator-initiated application, is to be submitted in 
response to an RFA, it is to be prepared as a NEW application.  That is the 
application for the RFA must not include an Introduction describing the 
changes and improvements made, and the text must not be marked to indicate the 
changes.  While the investigator may still benefit from the previous review, 
the RFA application is not to state explicitly how.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by CSR and 
responsiveness by NIOSH.  Incomplete applications will be returned to the 
applicant without further consideration.

Incomplete 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 Receive a written critique
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 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 your 
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 your application=s overall score, weighting them as appropriate 
for each application.  Your 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 you may propose to carry out 
important work that by its nature is not innovative but essential to move a 
field forward.

SIGNIFICANCE:  Does this study address an important problem in the area of 
work-related musculoskeletal disorders?  If the aims of the applications are 
achieved, how will scientific knowledge be advanced?  What will be the effect 
of these studies on the concepts or methods that drive this field?  Will the 
proposed research contribute to the overall aim of better defining the 
exposure-response relationships between varying levels of job physical 
stressors and low back disorders?

APPROACH: Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas and consider 
alternatives?  Does the recruitment plan address the need to enroll workers 
with a range of exposure to the physical demands of lifting and manual 
material handling (high, medium and low) to have sufficient exposure contrast 
to assess exposure response?  Is the plan for assembling work sites and 
participants suitable for this study? Will these worksites provide 
participants who will be representative of the US workforce? Does the project 
employ standardized, comparable approaches for exposure assessment such as the 
NIOSH Lifting Equation?  Is the time line for the studies appropriate and well 
described?  Are the methods for assuring privacy and maintaining 
confidentiality of participant records, including specific protections for 
computerized data systems adequate?  Is there adequate consideration of follow 
up of study participants to assess changes in exposure and health outcomes?  
Does the proposed project provide an appropriate approach for maintaining 
participation over the study time period?  Is there adequate consideration of 
data design and analysis issues related to prospective studies of 
musculoskeletal disorders, such as sample size, drop outs, multiple 
comparisons, and recurrent and episodic health outcomes? 

INNOVATION:  Does the project employ novel concepts, approaches, or methods? 
Are the aims original and innovative?  Does the project challenge existing 
paradigms or develop new methodologies or technologies?  Are the investigators 
open to coordinating methods of data collection and analysis with other MSDC 
consortium members?

INVESTIGATORS:  Are the Principal Investigator, Co-Principal Investigators and 
their teams appropriately trained and have adequate experience to conduct both 
exposure and health assessments in order to evaluate exposure response?  Does 
the team have a multidisciplinary background to design and conduct a 
prospective epidemiologic field study? Is the work proposed appropriate to the 
experience level of the principal investigator and his/her collaborators?

ENVIRONMENT:  Does the scientific environment in which the work will be done 
significantly contribute to the probability of success?  Do the proposed 
experiments take advantage of unique features of the scientific environment or 
employ useful collaborative arrangements?  Is there evidence of institutional 
support to facilitate and maintain a high response rate?  Does the proposed 
project utilize an existing resource or constitute a new one?

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).
 
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.  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 CONSIDERATIONS 

DATA SHARING:  The adequacy of the proposed plan to share data. 

BUDGET:  The reasonableness of the proposed budget and the requested period of 
support in relation to the proposed research.

PROGRAMMATIC REVIEW CRITERIA

(1)  Magnitude and severity of the condition (problem) in the worker 
population.
(2)  Likelihood of developing applied technical knowledge for the prevention 
of occupational safety and health hazards on a national or regional basis.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date: May 20, 2003
Application Receipt Date: June 12, 2003
Earliest Anticipated Award Date: September 30, 2003

AWARD CRITERIA

Award criteria that will be used to make award decisions include:
o Scientific and technical merit
o Availability of funds 
o Programmatic priorities

REQUIRED FEDERAL CITATIONS

OFFICE OF MANAGEMENT AND BUDGET CLEARANCE: Projects that involve the 
collection of information from ten or more individuals and are funded by this 
cooperative agreement will be subject to review by the Office of Management 
and Budget (OMB) under the Paperwork Reduction Act.

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.

All awardees of CDC grants and cooperative agreements and their performances 
sites engaged in human subjects research must file an assurance of compliance 
with the regulations and have continuing reviews of the research protocol by 
appropriate institutional review boards.

In order to obtain a federal-wide Assurance (FWA) of Protection for Human 
Subjects, the applicant must complete an on-line application at the Office for 
Human Research Protections (OHRP) website or write to the OHRP for an 
application.  OHRP will verify that the signatory official and the Human 
Subjects Protections Administrator have completed the OHRP Assurance 
Training/Education Module before approving the FWA.  Existing Multiple Project 
Assurances (MPAs), Cooperative Project Assurances (CPAs), and Single Project 
Assurances (SPAs) remain in full effect until they expire or until December 
31, 2003, whichever comes first.

To obtain a FWA contact the OHRP at: http://www.hhs.gov/ohrp/assurances/assurances_index.html 
or write to:
Office for Human Research Protections (OHRP)
Department of Health and Human Services
6100 Executive Boulevard, Suite 3B01, MSC 7501
Rockville, Maryland 20892-7507
(Note: For Express or Hand Delivered Mail, Use Zip Code 20852)

Note: In addition to other applicable committees, Indian Health Service (IHS) 
institutional review committees must also review the project if any component 
of IHS will be involved with or will support the research.  If any American 
Indian community is involved, its tribal government must also approve the 
applicable portion of that project.

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-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.

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:  tc 
"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. 
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 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 NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals 
for NIH funding must be self-contained within specified page limitations. 
Unless otherwise specified in an NIH 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 Center 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, NIOSH/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 NIOSH/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 NIOSH/CDC grants and cooperative agreements need to be careful 
to prevent NIOSH/CDC funds from being used to influence or promote pending 
legislation.  With respect to conferences, public events, publication, and 
"grass roots" activities that relate to specific legislation, recipients of 
NIOSH/CDC funds should give attention to isolating and separating the 
appropriate use of NIOSH/CDC funds from non-NIOSH/CDC funds.  NIOSH/CDC also 
cautions recipients of NISOH/CDC funds to be careful not to give the 
appearance that NIOSH/CDC funds are being used to carry out activities in a 
manner that is prohibited under Federal law.

SMALL, MINORITY, AND WOMEN-OWNED BUSINESS: It is a national policy to place a 
fair share of purchases with small, minority and women-owned business firms. 
The Department of Health and Human Services is strongly committed to the 
objective of this policy and encourages all recipients of its grants and 
cooperative agreements to take affirmative steps to ensure such fairness. In 
particular, recipients should:

1. Place small, minority, women-owned business firms on bidders mailing lists.

2. Solicit these firms whenever they are potential sources of supplies, 
equipment, construction, or services.

3. Where feasible, divide total requirements into smaller needs, and set 
delivery schedules that will encourage participation by these firms.

4. Use the assistance of the Minority Business Development Agency of the 
Department of Commerce, the Office of Small and Disadvantaged Business 
Utilization, DHHS, and similar state and local offices.

RESEARCH INTEGRITY: The signature of the institution official on the face page 
of the application submitted under this Program Announcement is certifying 
compliance with the Department of Health and Human Services (DHHS) regulations 
in Title 42 Part 50, Subpart A, entitled "Responsibility of PHS Awardee and 
Applicant Institutions for Dealing with and Reporting Possible Misconduct in 
Science."
The regulation places several requirements on institutions receiving or 
applying for funds under the PHS Act that are monitored by the DHHS Office of 
Research Integrity's (ORI) Assurance Program. 
For examples:
Section 50.103(a) of the regulation states: "Each institution that applies for 
or receives assistance under the Act for any project or program which involves 
the conduct of biomedical or behavioral research must have an assurance 
satisfactory to the Secretary (DHHS) that the applicant: (1) Has established 
an administrative process, that meets the requirements of this subpart, for 
reviewing, investigating, and reporting allegations of misconduct in science 
in connection with PHS-sponsored biomedical and behavioral research conducted 
at the applicant institution or sponsored by the applicant; and (2) Will 
comply with its own administrative process and the requirements of this 
Subpart."
Section 50.103(b) of the regulation states that: "an applicant or recipient 
institution shall make an annual submission to the [ORI] as follows: (1) The 
institution's assurance shall be submitted to the [ORI], on a form prescribed 
by the Secretary,...and updated annually thereafter...(2) An institution shall 
submit, along with its annual assurance, such aggregate information on 
allegations, inquiries, and investigations as the Secretary may prescribe." 

HEALTHY PEOPLE 2010: CDC is committed to achieving the health promotion and 
disease prevention objectives of "Healthy People 2010," a national activity to 
reduce morbidity and mortality and improve 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 under 93.262: Occupational Safety and Health Research 
Grants at http://www.cfda.gov/ and is not subject to the intergovernmental 
review requirements of Executive Order 12372 or Health Systems Agency review. 
This program is authorized under the Public Health Service Act, as amended, 
Section 301(a)[42 U.S.C. 2419a)], and the Occupational Safety and Health Act 
of 1970, Section 20(a) {29 U.S.C. 669(a)}. The applicable program regulation 
is 42 CFR Part 52. The NIH Grants Policy Statement can be found at 
http://grants.nih.gov/grants/policy/policy.htm 

SMOKE-FREE WORKPLACE: The PHS/CDC/NIOSH 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.

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