MUSCULOSKELETAL DISORDERS:  PREVENTION AND TREATMENT

Release Date:  October 22, 2001

RFA:  RFA-OH-02-004

National Institute for Occupational Safety and Health, (NIOSH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases,(NIAMS)

Letter of Intent Receipt Date:  December 4, 2001
Application Receipt Date:       January 15, 2002

THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  
MODULAR INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS 
REQUESTING LESS THAN $250,000 PER YEAR IN ALL YEARS. MODULAR 
BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 
(REVISION 5/2001) AVAILABLE AT 
http://grants.nih.gov/grants/funding/phs398/phs398.html.

PURPOSE

This initiative marks the continued collaborative efforts of the 
National Institute of Occupational Safety and Health (NIOSH) and 
the National Institute of Arthritis and Musculoskeletal and Skin 
Diseases (NIAMS) to support research focused on the prevention and 
treatment of musculoskeletal disorders (MSDs).  The intent of this 
Request for Applications (RFA) is to support research in the areas 
of health and hazard surveillance, basic etiologic and medical 
evaluation, biomechanical and mechanobiological studies, diagnosis 
and treatment of MSDs, and the development and evaluation of new 
and existing interventions aimed at prevention.  In particular, 
applications are solicited that are aimed at research topics 
involving the highest levels of risk, the most severe exposures, 
those with the most frequent occurrence, or those with the 
greatest opportunity for prevention or treatment of MSDs.  

The research needs identified in this announcement are consistent 
with the National Occupational Research Agenda (NORA) developed by 
NIOSH and partners in the public and private sectors to provide a 
framework to guide occupational safety and health research in the 
new millennium towards topics which are most pressing and most 
likely to yield gains to the worker and the nation.  The agenda 
identifies 21 research priorities.  NORA priorities with specific 
relevance to this announcement are: traumatic injuries; 
intervention effectiveness research; and control technology and 
personal protective equipment.  Information about NORA is 
available through the NIOSH Home Page;  
http://www.cdc.gov/niosh/norhmpg.html. You may also refer to   
http://www.cdc.gov/funding.htm.

HEALTHY PEOPLE 2010


CDC and the NIH are 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 announcement is related to the focus 
area of Occupational Safety and Health.  For a copy of AHealthy 
People 2010" (Full Report: Stock No. 017-001-00547-9), write or 
call: Superintendent of Documents, Government Printing Office, 
Washington D.C. 20402-9325, telephone (202) 512-1800 or visit the 
internet site:  http://www.health.gov/healthypeople/.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign, public and 
private nonprofit and for-profit organizations and by governments 
and their agencies; that is, universities, colleges, research 
institutions, hospitals, other public and private nonprofit and 
for-profit organizations, State and local governments or their 
bona fide agents, including the District of Columbia, the 
Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth 
of the Northern Mariana Islands, American Samoa, Guam, the 
Federated States of Micronesia, the Republic of the Marshall 
Islands, and the Republic of Palau, federally recognized Indian 
tribal governments, Indian tribes, or Indian tribal organizations, 
and small, minority, and women-owned businesses that meet the 
above criteria.  Racial/ethnic minority individuals, women, and 
persons with disabilities are encouraged to apply as 
Principal Investigators.

Note: Title 2 of the 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.

MECHANISM OF SUPPORT

The mechanism of support will be the individual research project 
grant (R01).  Responsibility for the planning, direction, and 
execution of the proposed project will be solely that of the 
applicant.  The total requested project period for an application 
submitted in response to this RFA may not exceed four years.  
Foreign grants are limited to 3 years.  This RFA is a one-time 
solicitation.

FUNDS AVAILABLE

The National Institute of Occupational Safety and Health (NIOSH) 
intends to commit approximately $1.0 million total direct costs in 
FY 2002 to fund up to 5 new grants and the National Institute of 
Arthritis and Musculoskeletal and Skin Diseases (NIAMS) intends to 
commit approximately $1.0 million total direct costs in FY 2003 to 
fund up to 5 new grants in response to this RFA.  The maximum 
amount that may be requested is $250,000 direct cost per year for 
laboratory-based studies and $500,000 direct cost for population-
based studies.  Although the financial plans of the NIOSH and 
NIAMS 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.

Awards will be made for a 12-month budget period within a project 
period up to four years.  Continuation awards within the project 
period will be made on the basis of satisfactory progress and 
availability of funds in future years.

Use of Funds

Applicants should include in their budgets funds for one trip per 
year for an annual meeting of grantees to be held in Washington, 
D.C.  The purpose of this meeting is to provide an opportunity for 
the exchange and dissemination of scientific information.

RESEARCH  OBJECTIVES

Background

Musculoskeletal disorders (MSDs) involving the upper extremities, 
lower extremities and the back are an important national health 
problem.  MSDs are one of the leading categories of injuries and 
illnesses in the work place, resulting in high levels of pain, 
discomfort, lost work time, and disability.  MSDs account for the 
largest fraction of temporary and permanent disability, and as the 
population ages and physical capabilities decline, more Americans 
will develop MSDs than ever before.  Many will require extensive 
adaptation of their work and home environment in order to maintain 
full functional capability.  Additionally, compensation costs for 
disability are also likely to continue to increase.  Fortunately, 
interventions have been shown to be effective in eliminating or 
reducing the frequency and severity of these disorders, and 
treatments have been shown to be effective in improving functional 
ability for injured individuals.  Additional research is needed, 
however, to increase the effectiveness of these prevention and 
treatment methods.

National Institute for Occupational Safety and Health,  National 
Occupational Research Agenda for Musculoskeletal Disorders: 
Research Topics for the Next Decade, DHHS(NIOSH) publication 
number 2001-117, NIOSH, Cincinnati, Ohio  45226.

National Research Council and Institute of Medicine, 
Musculoskeletal Disorders and the Workplace: Low Back and Upper 
Extremities, National Academy Press, Washington, D.C.

Objectives

Applications are requested from any discipline to examine a wide 
range of factors in a variety of settings.  The study of the 
combined or interactive effects of physical and non-physical 
factors is of special interest.  This RFA is requesting proposals 
to conduct studies aimed at the ongoing systematic collection, 
analysis, interpretation, and dissemination of MSD health and 
hazard information in order to identify trends, develop prevention 
strategies, and evaluate the effectiveness of those strategies.  
Examples of topic areas of interest include, but are not limited to:

Epidemiological Research - Studies designed to improve 
epidemiologic research tools and studies examining the dose-
response relationship between exposure to risk factors and the 
health outcomes are needed.  Specific topics include:

o  Quantifying the relationship between exposures and MSD outcomes 
in both cross-sectional and prospective study designs

o  Development of improved tools for measuring exposures (dose) 
and health outcomes (response), such as force, posture, motion, 
and vibration; tools should be practical, consistent, precise, 
accurate, and easy to use.

o  Development/refinement of epidemiologic tools with adequate 
sensitivity and specificity for epidemiologic study in work and 
non-work environments.  Studies should address tools or criteria 
that focus on physical examination and sensory discrimination 
criteria to identify MSD outcomes, epidemiologic case definitions 
for MSDs, standardized survey instruments to identify symptomatic 
MSD outcomes, and physiological measures appropriate for measuring 
relevant features of MSDs.

Etiological and Medical Research - Research is needed to better 
describe the relationship between exposure to risk factors, both 
singly and in combination, and the development of disease and 
disability.  Specific examples of topics of interest include:

o  Refining instruments to detect and quantify the contribution of 
risk factors to the disease process.

o  Studies aimed at clearly defining stages of the MSD process and 
delineating the natural history of MSD (pathogenesis and recovery). 

o  Studies focusing on clarifying the interaction of factors at 
different stages of causation, development, and treatment of MSD 
and measurement of those risk factors.

o  Investigations focusing on determining the impact of personal 
factors on risk of MSD, including studies investigating the 
relative effects of differences in age, gender, physical 
conditioning, biological characteristics, cultural differences, 
diurnal variations, genetics, and history of previous 
injury/illnesses (acute, cumulative, or chronic) is needed.

Psychosocial and Work Organization Research - Studies aimed at 
determining the effects of psychological, psychosocial, and work 
organizational factors on the occurrence of MSD are needed.  
Specifically, investigations are needed to determine the 
mechanisms through which psychosocial and work organizational 
stressors contribute to or impact development of MSDs.  Specific 
examples of topics of interest include studies directed at 
determining the effects of the following factors on development of MSDs:

o  Stressful working conditions, such as hectic or routine tasks 
and unrealistic deadlines.

o  Individual and situational non-work factors, such as balance 
between work and family or personal life, social support network, 
personality, and coping skills.

o  Poor interpersonal relationships, indefinite work roles, and 
lack of worker involvement in decision making.

o  Work schedules, including extended hours of work, shift work, 
and mandatory overtime.

o  Specific types of work, such as paced work, piecework, and teamwork.

o  Non-stereotypical work arrangements and management style, such 
as telecommuting, temporary work assignments, and other 
supervisory or management staffing arrangements.

o  Down-sizing and labor surpluses and shortages

Biomechanical and Mechanobiology Research - Laboratory and field 
studies examining the impact of biomechanical risk factors 
including exposures to excessive force, awkward posture, rapid 
movement, and vibration in human and animal studies.  These can be 
characterized in terms of their magnitude and temporal factors, 
such as frequency, repetition, duty cycle, and duration of 
exposure.  Specific topics of interest include:

o  Characterizing ultrastructural and cellular responses to 
cyclical physical loading exposure for vertebrae/disc, upper 
extremity tendon and muscle, articular cartilage, and peripheral 
nerve using in vivo animal models.

o  Investigating how risk factors affect tissue loading patterns 
and tolerance limits for joints and soft tissues in humans, 
including quantifying the relationship between loading and the 
pain process, as well as exploring the influence of psychological 
stress on the function of the musculoskeletal system and the 
resulting mechanical loading of the joints.

Intervention Research - Research is also needed to develop and 
evaluate new and existing intervention strategies for preventing 
or reducing the incidence, severity, and disability associated 
with MSDs.  A large amount of research has been conducted over the 
past few decades, but because of the wide variability between 
individuals and the complexity of causal and contextual factors 
and their interactions, there is a need for more research to 
evaluate which interventions are the most effective.  Because 
intervention research is difficult to conduct and adequate 
comparison controls are often not available, very large sample 
sizes may be needed to show that an intervention is effective in 
reducing health outcomes.  Therefore, studies aimed at 
demonstrating reduced exposure may be equally useful in evaluating 
the effectiveness of interventions.  Specific examples of topics 
of interest include:

o  Determining the effectiveness of alternative (product and/or 
tool) design criteria (force, spatial requirements of work).

o  Determining the effectiveness of reducing or optimizing the 
mechanical work demands (force, movement, and posture) and 
temporal patterns of exposure.

o  Determining the effectiveness of training and education programs.

o  Determining the effectiveness of exercise and stretching programs.

o  Development and evaluation of methods for determining the costs 
and benefits of ergonomic interventions.

o  Determining the effectiveness of worker selection/placement and 
job assignment on prevention of MSDs.

o  Determining the effectiveness of emerging prevention technologies.

o  Conducting rigorous evaluation of workplace interventions 
including but not limited to randomized controlled trials or other 
scientifically valid approaches.

o  Promoting investigation of multifactoral interventions.

Special Populations - Studies focusing on the impact of MSDs on 
selected sub-groups of the population are needed, such as 
children, older individuals, minorities, women, and other 
understudied populations.  Examples of specific topics of interest include:

o  Identify and evaluate unique MSD risks for children and women.

o  Evaluate how changes in tolerance due to aging impacts upon risk for MSDs.   
o  Determine the impact of aging on the healing and recovery process. 

o  Collect anthropometric and work capacity data for older 
individuals to determine how anthropometric variables change with age.

o  Evaluate whether individuals with pre-existing conditions, such 
as diabetes, cancer, neurological disorders, etc., are at 
increased risk for development of MSDs.

o  Evaluate the impact of occupational and non-occupational 
exposures to children on future development of MSDs.

Diagnosis and Treatment - Research efforts are needed to improve 
and standardize methods of identification and evaluation of MSD 
outcomes.  Studies aimed at evaluating the efficacy of various 
forms of treatment are needed.  Specific topics of interest include:

o  Develop standard definitions for work-related MSD, risk 
factors, and for terms, such as discomfort, pain, injury, disease, 
disability, and recovery.  Establish endpoints that are clear, 
definitive, valid, and reliable. 

o  Development of  precise diagnostic tools that are effective in 
early identification of MSDs.

o  Development of guidelines for effective treatment and return to work.

o  Establish approved methods and objective tests to diagnose and 
evaluate whether an injury is physical, psychological, or psychosocial.  

o  Standardize diagnostic physical examinations.  

o  Evaluate available high-technology imaging tools, such as 
microsensors and magnetic resonance imaging (MRI), for the 
diagnosis of MSD, and design new diagnostic tools specifically for 
musculoskeletal injury research.  

o  Develop and validate biochemical markers to identify injured individuals

o  Conduct research (clinical trials) to evaluate the efficacy of 
various forms of treatment for MSD, including surgery and 
rehabilitation.  Evaluate the impact of workers compensation and 
disability benefit availability and other factors on treatment 
and outcome.

Useful References

National Institute for Occupational Safety and Health. 
Musculoskeletal Disorders and Workplace Factors. A Critical Review 
of Epidemiological Evidence for Work-Related Musculoskeletal 
Disorders of the Neck, Upper Extremities, and Low Back. 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.97-
141 (http://www.cdc.gov/niosh/nora.html).

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the CDC and the NIH to ensure that individuals 
of both sexes and the various racial and ethnic groups will be 
included in CDC and NIH-supported research projects involving 
human subjects, whenever feasible and appropriate. Racial and 
ethnic groups are those defined in OMB Directive No. 15 and 
include American Indian or Alaska Native, Asian, Black or African 
American, Hispanic or Latino, Native Hawaiian or other Pacific 
Islander.  Applicants shall ensure that women, racial and ethnic 
minority populations are appropriately represented in applications 
for research involving human subjects.  Where clear and compelling 
rationale exist that inclusion is inappropriate or not feasible, 
this situation must be explained as part of the application.  This 
policy does not apply to research studies when the investigator 
cannot control the race, ethnicity, and/or sex of subjects.  
Further guidance to this policy is contained in the Federal 
Register, Vol. 60, No. 179, pages 47947-47951, and dated Friday, 
September 15, 1995.

All investigators proposing research involving human subjects 
should read the "NIH Guidelines For Inclusion of Women and 
Minorities as Subjects in Clinical Research," published in the NIH 
Guide for Grants and Contracts on August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); 
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of CDC and the NIH 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.  This policy will be followed 
by NIOSH for this announcement. 

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 was published in the NIH Guide for Grants and Contracts, 
March 6, 1998, and is available at the following URL address: 
http://grants.nih.gov/grants/funding/children/children.htm.
Investigators also may obtain copies of these policies from the 
program staff listed under INQUIRIES. Program staff may also 
provide additional relevant information concerning the policy.

HUMAN SUBJECTS REQUIREMENTS

If the proposed project involves research on human subjects, the 
applicant must comply with the Department of Health and Human 
Services (DHHS) Regulations (Title 45 Code of Federal Regulations 
Part 46) regarding the protection of human research subjects.  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.

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.  This policy announcement is 
found in the NIH Guide for Grants and Contracts Announcement dated 
June 5, 2000, at the following website:  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

ANIMAL SUBJECTS REQUIREMENTS

If the proposed project involves research on animal subjects, 
compliance with the "PHS Policy on Humane Care and Use of 
Laboratory Animals by Awardee Institutions" is required.  An 
applicant (as well as each subcontractor or cooperating 
institution that has immediate responsibility for animal subjects) 
proposing to use vertebrate animals in CDC-supported activities 
must file (or have on file) the Animal Welfare Assurance with the 
Office of Laboratory Animal Welfare (OLAW) at the National 
Institutes of Health. The applicant must provide in the 
application the assurance of compliance number and evidence of 
review and approval (including the date of the most recent 
approval) by the Institutional Care and Use Committee (IACUC).  
Web page http://grants.nih.gov/grants/olaw/references/phspol.htm.

URLS IN NIOSH and NIH GRANT APPLICATIONS OR APPENDICES

All applications must be self-contained within specified page 
limitations.  Unless otherwise specified, 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.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an internet site.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT  

By regulation (45 CFR 74.36), grantees that are institutions of 
higher education, hospitals, or non-profit organizations are 
required to provide public access to research data through the 
Freedom of Information Act (FOIA) under some circumstances (OMB 
Circular A-110).  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.  For further 
information on this policy refer to page 52 in the PHS 398 grant 
application or access the NIH Guide for Grants and Contracts 
Announcement at:  
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this 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.  

LETTER OF INTENT

Prospective applicants are asked to submit, by December 4, 2001, a 
letter of intent that includes the number and title of the RFA, a 
descriptive title of the proposed research, the name, address, and 
telephone number of the Principal Investigator, and the identities 
of other key personnel and participating institutions.  Although a 
letter of intent is not required, is not binding, and is not used 
in 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 submitted to:

Pervis C. Major, Ph.D.
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 PROCEDURES  

The PHS 398 research grant application instructions and forms 
(rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.pdf must be 
used in applying for these grants. This version of PHS 398 is 
available in an interactive, searchable format. For further 
assistance contact GrantsInfo, Telephone 301/435-0714, Email: 
GrantsInfo@nih.gov.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS  

The modular grant concept establishes specific modules in which 
direct costs may be requested as well as a maximum level for 
requested budgets. Only limited budgetary information is required 
under this approach.  The just-in-time concept allows applicants 
to submit certain information only when there is a possibility for 
an award. It is anticipated that these changes will reduce the 
administrative burden for the applicants, reviewers and NIH staff. 
The research grant application form PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html is to be 
used in applying for these grants, with modular budget 
instructions provided in Section C of the application instructions. 

The RFA label available in the PHS 398 (rev. 5/2001) application 
form (http://grants.nih.gov/grants/funding/phs398/labels.pdf) 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.  

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.
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 

Applications must be received by January 15, 2002.  If an 
application is received after that date, it will be returned to 
the applicant without 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.  CSR and NIOSH will not accept 
any application that is essentially the same as one already 
reviewed.  This does not preclude the submission of a substantial 
revision of an application already reviewed, but such an 
application must follow the guidance in the PHS Form 398 
application instructions for the preparation of revised 
applications, including an Introduction addressing the previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by 
CSR and responsiveness by NIOSH. Applications determined to be 
incomplete or unresponsive to this RFA will be returned to the 
applicant without further consideration.  Applications that are 
complete and responsive to the RFA will be reviewed for technical 
merit by a scientific review group convened by NIOSH.

All applications will be judged on the basis of the scientific 
merit of the proposed project and the documented ability of the 
investigators to meet the RESEARCH OBJECTIVES of the RFA.  As part 
of the scientific merit review, all applications will receive a 
written critique and undergo a process in which only those 
applications deemed to have the highest scientific merit, 
generally the top half of applications under review, will be 
discussed and assigned a priority score.

The criteria that NIOSH will use to review applications for 
scientific merit and for meeting program objectives are provided below.

Scientific Review Criteria

o  Significance - Does this study address an important problem 
related to the topical research issues outlined in this 
announcement?  If the aims of the application 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?

o  Approach - Are the conceptual framework, design (including 
composition of study population), methods, and analyses adequately 
developed, well-integrated and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas 
and consider alternative tactics?

o  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?

o  Investigator - Is the investigator appropriately trained and 
well-suited to carry out this work?  Is the work proposed 
appropriate to the experience level of the principal investigator 
and other researchers, if any?

o  Environment - Does the scientific environment in which the work 
will be done 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 documentation of cooperation from 
industry, unions, communities, or other participants in the 
project, where applicable?  Is there evidence of institutional 
support and availability of resources necessary to perform the project?

o  Adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of 
the research.  Plans for the recruitment and retention of subjects 
will also be evaluated.  

o  The adequacy of the proposed protection of humans, animals, or 
the environment, to the extent that they may be adversely affected 
by the project proposed in the application.  

o  Availability of special opportunities for furthering research 
programs through the use of unusual talent resources, populations, 
or environmental conditions in other countries which are not 
readily available in the United States or which provide 
augmentation of existing U.S. resources.  

Programmatic Review Criteria

o  Magnitude of the problem in terms of numbers of workers affected.

o  Severity of the disease or injury in the worker population.

o  Likelihood of developing applied technical knowledge for the 
prevention of occupational safety and health hazards on a national 
or regional basis.

SCHEDULE

Letter of Intent Receipt Date:    December 4, 2001
Application Receipt Date:         January 15, 2002
Earliest Anticipated Award Date:  August 1, 2002 (NIOSH)/October 1, 2002 (NIAMS)

AWARD CONSIDERATIONS

Applications will be considered for award based upon (a) 
scientific merit, (b) program importance, (c) program balance of 
research areas, and (d) availability of funds.  

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to 
clarify any issues or questions from potential applicants is 
welcome.  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" and on the NIAMS Homepage (http://www.nih.gov/niams) 
under "Grants & Contracts", "Requests for Applications", "Currently Active RFAs".

Direct inquiries regarding NIOSH programmatic issues to:

Michael Galvin, Ph.D.
Office of Extramural Programs
National Institute for Occupational Safety and Health
1600 Clifton Road, N.E.
Building 1, Room 3053, MS D-30
Atlanta, GA  30333
Telephone:  (404) 639-3343
FAX:  (404) 639-4616
Email:  mgalvin@cdc.gov

Direct inquiries regarding NIAMS programmatic issues to:

James S. Panagis, MD, MPH
Director, Orthopaedics Program
National Institute of Arthritis and Musculoskeletal and Skin Diseases
45 Center Drive, Room 5AS-37K, MSC 6500
Bethesda, MD  20892-6500
Telephone:  (301) 594-5055
FAX:  (301) 480-4543
E-mail:  jp149d@nih.gov

Direct inquiries regarding grants management business matters to:

Joanne Wojcik
Grants Management Branch
Procurement and Grants Office
CDC Announcement Number CDC 02015
Centers for Disease Control and Prevention
2920 Brandywine Road, Suite 3000
Atlanta, GA  30341-4146
Telephone:  770/488-2717
Email:  jcw6@cdc.gov

Ms. Melinda Nelson
Grants Management Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
45 Center Drive, Room 5AS-37K, MSC 6500
Bethesda, MD  20892-6500
Telephone:  (301) 594-3535
FAX:  (301) 480-5450
E-mail:  mn23Z@nih.gov

AUTHORITY AND REGULATIONS

The Catalog of Federal Domestic Assistance number is: 93.262 for 
the National Institute for Occupational Safety and Health 
(NIOSH)and 93.846 for the National Institute of Arthritis and 
Musculoskeletal and Skin Diseases (NIAMS).  This program is 
authorized under the Public Health Service Act, as amended, 
Section 301(a) [42 U.S.C. 241(a)], 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.  This program is 
not subject to the intergovernmental review requirements of 
executive order 12372 or Health Systems Agency Review.

LOBBYING RESTRICTIONS

Applicants should be aware of restrictions on the use of Health 
and Human Services (HHS) 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, 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.

SMOKE-FREE WORKPLACE

CDC strongly encourages all grant recipients to provide a 
smoke-free workplace and promote the non-use of all tobacco 
products, and Public Law 103-227, the Pro-Children Act of 1994, 
prohibits smoking in certain facilities that receive Federal funds 
in which education, library, day care, health care, and early 
childhood development services are provided to children.

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:

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

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

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

o  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."


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