Collaborative Program for the Identification and Prevention of 
Work-related Musculoskeletal Disorders

RELEASE DATE:  May 2, 2002

RFA: OH-02-010

PARTICIPATING INSTITUTES AND CENTERS (ICs): 

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

LETTER OF INTENT RECEIPT DATE: June 11, 2002
  
APPLICATION RECEIPT DATE: July 11, 2002

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the RFA
o Research Objectives
o Mechanism(s)of Support
o Funds Available
o Use of Funds
o Eligibility Considerations and Requirements
o Special Requirements
o Terms and Conditions of Award
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 invites 
applications for Cooperative Agreements (U01s) from single 
institutions or consortia of institutions who are capable of, and 
interested in, conducting research to quantify the risk for upper 
limb and low back musculoskeletal disorders at varying levels of 
exposure to physical job stressors (repetitive motion, forceful 
exertion, awkward postures, manual handling, etc.).

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.  In 1996, a 
total of 600,390 work-related musculoskeletal injury cases 
resulting in work absence or restriction were reported to be 
caused by overexertion and repetitive motion by the Bureau of 
Labor Statistics (BLS).  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% of 
all workers= compensation claims and 46% 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.  Past studies primarily have been cross sectional 
or retrospective, the limitations of these approaches for 
determining exposure response relationships have been widely 
discussed in the scientific literature. 

This RFA builds on an initial effort (see 
http://grants.nih.gov/grants/guide/rfa-files/RFA-OH-00-003.html)
in 2000 to begin a Collaborative Program for the Identification 
and Prevention of Work-related Musculoskeletal Disorders.  The 
current RFA expands this program by making available additional 
funds to meet the objective of collecting sufficient data to 
better understand exposure response relationships between physical 
stressors and MSDs.   An integral part of this initiative is 
participation in a Work-related Musculoskeletal Disorders 
Consortium (MSDC).  In order to achieve the goals of this program, 
it is important to have common data elements shared 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 
that workers undergo standard health tests to identify MSDs. 
Etiology is a critical element in meeting the RFA objective of 
studying MSD. 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 MSDC.  New awardees under this current RFA will also have 
one 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.   The NIOSH liaison serves as a non-voting member of the 
CC.

Research Goals  

An anticipated outcome of this research program will be better 
defined exposure-response relationships between job physical 
stressors and musculoskeletal disorders across industries.  
Information regarding the utility of practical methods that could 
be readily employed by occupational safety and health 
practitioners, such as the American Conference of Governmental 
Industrial Hygienists Threshold Limit Value for Hand Activity and 
the NIOSH Lifting Equation, is another anticipated outcome.  With 
such knowledge, effective job design changes or interventions can 
be developed that reduce the burden of work-related MSDs.  

The MSDC will combine the expertise and resources of NIOSH 
research staff with those of external collaborators.  It is 
anticipated that up to four new extramural partners that 
demonstrate expertise in 1) upper limb MSDs (CTS, hand-wrist 
tendinitis, epicondylitis) at varying levels of hand activity, 
exertion, and other physical stressors in job tasks, and/or 2) low 
back pain in relation to physical demands of lifting and manual 
handling tasks will be awarded cooperative agreements and will 
participate in the MSDC.  Individual investigators will be free to 
analyze and publish data from the work sites they study.  In 
addition, each investigator will be responsible for providing data 
to a data coordinating center in a uniform fashion. 

The intent of this initiative is to assemble a cross-disciplinary, 
multi-institutional consortium to define exposure response 
relationships among physical job stressors and upper limb and low 
back MSDs.  To accomplish this objective, it is envisioned that 
the following research areas be examined: 1) upper limb MSDs at 
varying levels of hand activity, exertion, and other physical 
stressors in job tasks, and 2) low back pain in relation to 
physical demands of lifting and manual handling tasks.  

USEFUL REFERENCE
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

The administrative and funding instrument to be used for this 
program will be a cooperative agreement (U01).  Details of the 
responsibilities, relationships and governance of the study to be 
funded under cooperative agreement(s) are discussed later in this 
document under the section Terms and Conditions of Award.

The total project period for an application submitted in response 
to this present RFA may not exceed four (4) years.  The 
anticipated award date is September 30, 2002.  The award and level 
of support depends on receipt of applications of high scientific 
merit.  The award pursuant to this RFA is contingent upon the 
availability of funds.  

An applicant may only submit applications that are limited in 
scope to one of the two research areas defined in this RFA.  On 
the face page of the application, line two, the applicant must 
indicate the proposed research, either 1)  upper limb MSDs (CTS, 
hand-wrist tendinitis, epicondylitis) at varying levels of hand 
activity, exertion, and other physical stressors in job tasks, or 
2) low back pain in relation to varying levels of physical demand 
due to lifting and manual handling tasks.  If an applicant wishes 
to apply for more than one research area, you must submit a 
separate and independent application.  Applications which address 
more than one of the RFA topics will be returned as non-
responsive.   

This RFA is a one time announcement.  If by the end of the fourth 
year of the award NIOSH has not determined whether or how this 
program will be continued, awardees should contact NIOSH program 
staff and consider submitting investigator-initiated (R01) 
application which will compete with all investigator-initiated 
applications and be reviewed according to the customary peer 
review procedures. 

FUNDS AVAILABLE

Approximately $1,000,000 is available in FY 2002 to fund two to 
four awards.  The maximum amount that may be requested is $500,000 
total cost (direct and indirect) per year.  

Awards will be made for a 12-month budget period within a project 
period up to four(4) years.

Continuation awards within an approved project period will be made 
on the basis of satisfactory progress as evidenced by required 
reports and the availability of funds.

USE OF FUNDS

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

ELIGIBILITY REQUIREMENTS

Applications may be submitted by 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 
small, minority and/or women-owned businesses.  Applications from 
minority and women investigators are encouraged.

SPECIAL CONSIDERATIONS AND 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  Time line: a detailed time line 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. 

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, such as health 
effects assessment for the upper extremities, field studies of 
working populations experiencing work-related MSDs and experience 
utilizing the NIOSH lifting equation,

o  Access to specific work sites and working populations that are 
willing to participate in studies of work-related MSDs,

o  Expertise in assessing work situations and individual job tasks 
in relation to the development of work-related MSDs, and/or

o  Expertise in interviewing workers and 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.

TERMS AND CONDITIONS OF AWARD

The Terms and Conditions of Award, below, will be incorporated in 
all awards 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, HHS 
Grant Administration Regulations in 45 CFR Parts 74 and 92, and 
PHS Grants Policy Statement.  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.  develop an appropriate data collection instrument,

b.  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,

c.  provide study participants with individual notification 
letters when medical tests are performed, 

d.  serve as a permanent member of the CC,  

e.  develop and submit semiannual progress reports in a standard 
format that is agreed upon after an award is made, 

f.  collaborate in the scientific reporting of findings, 

g.  provide program management oversight for the project, and 

h.  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.  NIOSH staff will:

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.  One external 
scientist from each award will have membership on the Coordination 
Committee, the NIOSH liaison will be a non-voting member.

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 CC may, when necessary, invite additional, non-voting 
scientific advisors to the meetings at which research priorities 
and opportunities are discussed.

It is anticipated that there will be two CC 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. 

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 and 
financial or grants management issues.  This RFA and other CDC 
Announcements can be found on the CDC HomePage (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  (www.cdc.gov/niosh) under Funding 
Opportunities.

Direct inquiries regarding programmatic issues to:

Lee M. Sanderson, Ph.D.
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 inquiries regarding grants management business matters to:

Mildred Garner or Robert Williams
Announcement Number OH-02-010
Grants Management Branch, Procurement and Grants Office
Centers for Disease Control and Prevention (CDC)
2920 Brandywine Road, Suite 3000
Atlanta, Georgia 30341
Telephone: 770-488-2745 or 770-488-2656
Email: [email protected] or [email protected]

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent by 
June 11, 2002, 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: 

Price Connor, Ph.D.
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 1423, MS E-74
Atlanta, GA  30333
Telephone 404-498-2511
Fax 404-498-2569
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. 

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:

Price Connor, Ph.D.
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 1423, MS E-74
Atlanta, GA  30333
Telephone 404-498-2511
Fax 404-498-2569
Email:  [email protected]

APPLICATION PROCESSING: Applications must be received by July 11, 
2002.  If an application is received after that date, it will be 
returned to the applicant without review.  

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.  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 include an introduction addressing the previous 
critique.

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.  

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.

(1) 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 job physical stressors and 
musculoskeletal disorders?

(2) 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?  Are the plans for the 
recruitment and retention of subjects adequate?  Is there adequate 
consideration of follow up of study participants?  For example, is 
the plan for follow up of participants adequate? Is the plan for 
tracking drop outs adequate?  Is the plan for assembling work 
sites and participants suitable for this study?  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?  Does the project employ 
standardized, comparable approaches for exposure assessment such 
as the American Conference of Governmental Industrial Hygienists 
Threshold Limit Value for Hand Activity and the NIOSH Lifting 
Equation.  

(3) 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?

(4) INVESTIGATORS:  Are the Principal Investigator, Co-Principal 
Investigators and their teams appropriately trained and have 
adequate experience to carry out this work?  Is the work proposed 
appropriate to the experience level of the principal investigator 
and his/her collaborators?

(5) 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?  Does the proposed project utilize an existing resource 
or constitute a new one?

(6) OTHER:  In addition to the above criteria, all applications 
will also be reviewed with respect to the following.  The 
reasonableness of the proposed budget and duration in relation to 
the proposed research.  The adequacy of plans to include both 
genders, minorities and their subgroups, for the scientific goals 
of the research.  The adequacy of the proposed protection for 
humans, animals, or the environment, to the extent they may be 
adversely affected by the project proposed in the application.

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: June 11, 2002
Application Receipt Date: July 11, 2002
Anticipated Award Date: September 30, 2002

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
o Program balance for the two study areas (priority for funding at 
least one for each area, low back and upper limb) provided 
applications are of sufficient scientific merit. 

REQUIRED FEDERAL CITATIONS

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN 
SUBJECTS:  It is the policy of the CDC to ensure that individuals 
of both sexes and the various racial and ethnic groups will be 
included in CDC-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-Amended, October 9, 
2001, published in the NIH Guide for Grants and Contracts on 
October 9, 2001, 
http://grants.nih.gov/grants/funding/women_min/women_min.htm.,a 
complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN 
SUBJECTS: It is the policy of 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 is available at 
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.  

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT 
PARTICIPANTS:  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 performance 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.  

Note: Investigators in states with existing statutes covering 
guidance for the protection of humans, will be asked to submit 
documentation detailing fully the state authority.  If a state 
does not have statutory authority for all the human subjects 
activities proposed in the application, the awardee must obtain 
human subject clearances as described above.  The project plan in 
the application must fully describe the involvement of human 
subjects and protections.  This information should be included in 
the Human Subjects Research Section of PHS 398.

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-(45 CFR 74.36) 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.  Guidance is 
provided 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. 

URLS IN NIOSH GRANT APPLICATIONS OR APPENDICES: All applications 
and proposals 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.

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, 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:

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.  For a copy of Healthy People 2010, 
visit the internet site:  
http://www.health.gov/healthypeople/default.htm

AUTHORITY AND REGULATIONS:  This program is described in the 
Catalog of Federal Domestic Assistance Number 93.262 for the 
National Institute for Occupational Safety and Health (NIOSH).  
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.

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