RELEASE DATE:  November 12, 2003
RFA Number:  RFA-OH-04-004 (see addendum NOT-OH-04-001)

Department of Health and Human Services (DHHS)

Centers for Disease Control and Prevention (CDC) 

National Institute for Occupational Safety and Health (NIOSH) 





o Purpose of this 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 Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations


The National Institute for Occupational Safety and Health (NIOSH), Centers for 
Disease Control and Prevention (CDC), invites applications for cooperative 
agreements from single institutions or consortia of institutions to 
investigate the health status of responders (workers and volunteers) involved 
in the World Trade Center (WTC) response. The targeted study population 
includes all responders including the Fire Department of New York City (FDNY) 
responders, who provided rescue, recovery, clean-up and restoration of 
essential services at the WTC disaster site following the September 11, 2001 



Following the collapse of the WTC on September 11, 2001, thousands of workers 
and volunteers (responders) provided rescue, recovery, clean-up and 
restoration of essential services.  In 2002, the Centers for Disease Control 
and Prevention funded two medical screening programs for these responders.  It 
is anticipated that when the baseline screening programs are complete in the 
winter of 2004, over 12,000 FDNY responders and over 12,000 other responders 
will have been evaluated. 

Results from these screening programs have found elevated rates of persistent 
upper and lower respiratory and mental health conditions. Exposure 
measurements from the WTC site confirm elevated levels of exposure to 
combustion products and other particulate matter in the period following 
September 11, 2001. Long-term follow-up of the exposed responders who have 
participated in the baseline screening program will provide important 
information regarding the long-term effects of these exposures and will 
provide an efficient method for early determination of the need for additional 
medical testing and notification of exposed responders.

Program Objectives

This RFA builds on the results of previous projects which focused on the 
establishment of the patient cohort and the initial health screening.  This 
patient cohort has been divided into the FDNY responders and other responders 
because of the unique health and exposure characteristics of the two groups.  
The goal for this initiative is to establish four to eight (4-8) Clinical 
Centers (CC) that will provide the follow-up health assessments for the 
responders.  One CC will be responsible for the FDNY responders, and a group 
of CCs will be responsible for the other responder cohort. It is anticipated 
that a CC would have adequate facilities to provide patient tracking, clinical 
screening, basic mental health assessment, patient data management, and 
referral to physicians for patients requiring follow-up care. The CC should be 
able to assist both insured and uninsured responders. Data from this patient 
group will help define the long term health care needs for the responder 
population, and also provide important information on the consequences of air 
pollutants, physical stressors, emotional stress, musculoskeletal exertions, 
and other occupational and environmental measures. Each CC will be responsible 
for providing data electronically to a data center (see below) in a uniform 

There will be two Data and Coordination Centers (DCC) that will provide data 
management and coordination.  It is envisioned that the clinical center for 
the FDNY responders will be served by one DCC and the clinical centers for the 
other responders will be served by the other DCC.  The two Data and 
Coordination Centers (DCCs) will be established to provide study coordination 
functions, data management support and other services.  One DCC will be 
responsible for the FDNY responder data and the other DCC will be responsible 
for the other responder data.  The applicants selected as the data center will 
be responsible for basic statistical analysis, outreach coordination, outlier 
follow-up, data monitoring, quality assurance and other coordinating 
functions. The DCCs will serve as a data collection resource, enabling the 
consortium investigator to analyze data from the CCs.  Because of the unique 
characteristics of the two responder cohorts maintained by the two DCCs, a 
merged data set of all responders is not part of this initiative.  The two 
DCCs will work together, and the Scientific Program Administrator will resolve 
differences between the DCCs if any arise.  

All of the CCs and the two DCCs will be coordinated through a World Trade 
Center Responder Health Consortium (WTCRHC), which is to provide a 
comprehensive and integrated program for the conduct of the follow-up studies 
of the current responder population as well as other responders who may be 
identified.  It is important that data elements which will be shared between 
awardees are managed in a uniform and compatible format.  In addition, because 
many of the shared data elements are based on clinical diagnosis, a critical 
role of the WTCRHC will be to assure that clinical diagnosis are conducted and 
interpreted in a uniform manner across the CCs.  In order to accomplish this 
goal, the WTCRHC will establish a Steering Committee (SC) which is described 
under the PROGRAM ORGANIZATION section of this announcement.

Project Organization

The WTCRHC will consist of the following components: four to eight (4-8) 
Clinical Centers, two Data and Coordinating Centers, NIOSH, a Steering 
Committee (SC), a Data Safety and Monitoring Board (DSMB), and an External 
Advisory Panel.  

The Principal Investigator at each CC will have primary responsibility to 
participate in the standardized study design and implementation to be used at 
all clinical locations, including subject recruitment and safety.  With the 
assistance of Co-Investigators as appropriate, the Principal Investigator will 
hire and supervise relevant personnel, obtain Institutional Review Board (IRB) 
approval for WTCRHC protocols, oversee data collection and adherence to 
quality assurance measures, and prepare budgets and annual reports.  The 
Principal Investigator (or designated alternate) will serve as a voting member 
of the SC.  A Clinical Coordinator at each CC will set up training systems, 
certify personnel, and establish procedures to ensure adherence to protocols, 
collection of high quality data, and accurate transmission of data to the DCC.

The application for a CC will be supported in two levels and should consist of 
the following:

a. Administrative and Planning Core
An administrative and Planning Core will provide the basic organizational 
structure for the clinical work. It will be responsible for tracking patient’s 
contact information, verifying eligibility for examinations, benefits 
information/patient referral, maintaining patient records, transferring core 
data to DCC, informed consent, Health Insurance Portability and Accountability 
Act (HIPAA) compliance, and participation in a quality assurance program.  The 
estimated direct cost for this component is $50-300K per year. 

The Administrative and Planning Core must have a leader who is capable of 
providing clinical and scientific leadership and who is willing to accept 
responsibility for the administration and integration of the health assessment 
program.  Assessment of the ability of the program principal investigator to 
lead a tightly integrated clinical program will be a significant consideration 
in the evaluation of the application.  

b. Clinical Services Core
The Clinical Services Core will be funded on a per patient basis (capitation), 
and the current plan is for an examination of the cohort approximately every 
18 months (a minimum of three examinations per patient) over the five-year 
project period. Based on the fees for similar services, NIOSH anticipates a 
capitation rate of $300-$800 depending on the final protocol approved by the 
SC and NIOSH.  Due to the unique characteristics of the fire fighter and other 
responder cohorts, the capitation rates, frequency of examinations and core 
elements may be different. The NIOSH Scientific Program Administrator will 
establish the capitation rate and resolve any differences in the protocols for 
the FDNY responders and other responders.  Applicants should provide in their 
application the capitation rate that their CC would require for the health 
screening model described below and fully describe a patient protocol based on 
this model. 

The current clinical protocol model consists of four components: core medical 
exam; basic mental health screening; patient referral; and data entry. The 
core medical exam consists of an updating of the exposure and medical history, 
a complete physical examination with emphasis on the upper and low respiratory 
tract, routine blood and urine screening, a standard chest x-ray (if 
indicated), and pulmonary function testing.  The basic mental health screening 
designed to identify those patients at risk for WTC-related mental health 
disorders such as anxiety disorders, depression and post traumatic stress 
disorders. Patients presenting with conditions that require medical follow-up 
are to be referred to an appropriate health care provider.  A CC should have 
in place a system for the referral of patients whether they have insurance or 
not. The data is to be stored in a standardized format that is established by 
the SC, and transmitted electronically to the DCCs.  The data management 
system must be Health Insurance Portability and Accountability Act (HIPAA) 

Data and Coordinating Centers 
A DCC will provide statistical support, a web-based or other electronic data 
entry site for the clinical data, quality assurance, follow-up for patients 
that do not self identify a clinical site, and coordination of follow-up for 
patients outside the geographical service areas of the CCs.  In general, a DCC 
will operate under the guidance of the SC.  It is envisioned that the clinical 
centers for the FDNY responders will be served by one DCC and the other 
clinical centers will be served by the other DCC.  The two DCCs will work 
together, and the Scientific Program Administrator will resolve differences 
between the DCCs if any arise.  Because of the unique characteristics of the 
two responder cohorts maintained by the two DCCs, a merged data set of all 
responders is not part of this initiative.

With SC guidance, the DCCs will develop data collection forms and operation 
manuals; assist in defining outcomes; and develop procedures for quality 
control, training, and data management. They will monitor the quality and 
quantity of data received from the CCs; provide relevant reports to the NIOSH, 
the CCs, and the Steering Committee; and serve as a central repository for 
study data, with the exception of any individual research projects. The DCC in 
consultation with the SC, will determine the appropriate capitation rates and 
will arrange contracts to provide services for examinations being provided 
outside of the geographic area of the CCs. The DCCs will prepare confidential 
data analyses and reports for the DSMB.  They will support manuscript 
preparation through data analysis, statistical consultation, editorial 
support, and meeting coordination.  The DCCs will schedule and make 
arrangements for all meetings of World Trade Center Responder Health Study’s 
committees and boards.  The DCCs will be subject to annual administrative 
review by NIOSH.

Specifically, the DCCs will work in collaboration with the WTCRHC members and 
NIOSH program staff to:

1. Coordinate with the SC on the selection of the common data collection 
protocols, and standardized forms, and the data entry system for the creation 
and maintenance of the Common Data Sets for measurements to be done in common 
by the CCs. The two DCCs will maintain separate Common Data Sets which due to 
unique characteristics of each cohort would not necessarily need to be 
identical.   Prepare, disseminate, and update the WTCRHC Common Data Sets, 
maintain a Manual of Procedures (MOP), data collection forms, databases, and 
results reporting summaries for the CC sites, and maintain and verify for 
correctness the resulting Common Data Sets.

2. Provide or arrange for training to all CC site personnel as needed on data 
management and analysis, HIPAA, and quality control and quality assurance.

3. Collaborate with the CC sites (conditional on approval by the Steering 
Committee and the NIOSH Scientific Program Administrator) in the analysis of 
common data both for internal use by the study sites and for publications. 

4. Provide the NIOSH Scientific Program Administrator, the DSMB, and the 
Steering Committee with reports based on statistical and other analyses of 
issues related to the two core data sets (FDNY and Other responders), or other 
needs arising during the course of studies.

5. Prepare detailed reports in standardized formats on progress of study-
specific recruitment, patient screenings, compliance, and adverse events, for 
use by the Steering Committee and DSMB. 

6. Prepare a list of all CC site-specific data items that are used. 

7. Maintain a database on adverse events and responses to them. 

8. Support the activities of the CC sites, the SC, and the DSMB through 
provision of materials, documentation support, meeting planning and logistics, 
and conference call coordination. This includes attendance at Steering 
Committee, subcommittee, and DSMB meetings to perform the functions listed 

9. Prepare and distribute the minutes and action items from the SC and DSMB 
meetings and conference calls, CC Site visits, and SC Subcommittee meetings, 
and provide timelines for the completion of actions items and updates on the 
status of action items as required. 

10. Assist the NIOSH Scientific Program Administrator in written, telephone, 
and electronic communications with the CC sites and with various committees as 

11. Establish databases that catalogue and disseminate information about all 
WTCRHC publications. 

12. Develop and maintain a public and private (secured, password-protected) 
WTCRHC Web page.

13. Translate written materials into Spanish, Polish and other required 

14. Develop, maintain, and coordinate the dissemination of information on 
benefits, occupational safety and health related to WTC and referrals. 

The Scientific Program Administrator will monitor subject recruitment and 
study progress, ensure disclosure of conflicts of interest and adherence to 
award policies. The NIOSH Scientific Program Administrator and CDC Grants 
Management Specialist will be responsible for fiscal management of the 
network, including calculation of capitation budget rates and awards.  NIOSH 
will appoint the Chairperson of the Steering Committee and the external 
advisory committee members with advice from the SC.  NIOSH will provide 
technical assistance as requested. 

Steering Committee
Voting members of the Steering Committee will include the Principal 
Investigator from each CC (or designated alternate), the Principal 
Investigator from each DCC (or designated alternate), representative for the 
external advisory committee (selected by NIOSH), and a Chairperson appointed 
by NIOSH. The Chairperson of the Steering Committee (who may or may not be a 
Principal Investigator of a participating CC) will oversee its functions and 
conduct the Steering Committee meetings. The NIOSH, National Cancer Institute 
and other National Institutes of Health Components Scientific Program 
Administrators will be non-voting members of this committee.   
The Steering Committee will develop and ensure compliance with 
clinical policies and procedures, identify and prioritize topics for 
investigation, and evaluate protocols proposed by the CCs. The Steering 
Committee will ensure that studies are properly conducted and monitored, that 
data are appropriately analyzed and interpreted, and that study results are 
reported in the scientific literature in a timely manner and disseminated to 
physicians involved in the care of WTCRHC participants.  Subcommittees, 
consisting of qualified individuals from the CCs, the DCC, and NIOSH, may be 
established by the Steering Committee to perform specific functions such as 
publications and presentations or quality control. The DCC supporting the 
other responder CCs will provide support for this committee.  An executive 
committee consisting of one FDNY CC representative, one other responder CC 
representative (selected by NIOSH with advice from the SC) and the NIOSH 
Scientific Program Administrator will resolve differences in the health 
assessment protocols for the two cohorts and other issues that cannot be 
resolved by the SC.  

Data and Safety Monitoring Board.  An independent group of experts in areas 
such as lung disease, mental health, biostatistics, clinical trials and 
ethics, who are not otherwise involved in the study, as well as lay persons, 
will be selected to evaluate the protocol prior to implementation, to 
review periodically the progress of the health assessments, and to ensure 
patient safety.  The DCC supporting the other responder CCs will provide 
support for this committee.  

External Advisory Committee
An external advisory committee of 10-20 members will be established for this 
program.  The members will be appointed by the Director, NIOSH with the advice 
of the SC.  The DCC supporting the other responder CCs will provide support 
for this committee.  

Research Projects

The clinical and analytical activities supported by this RFA may be 
complemented by research projects at the clinical sites that are funded 
through individual research projects submitted to the NIH or NIOSH.  These 
projects would be conducted by the individual CCs, and the data would be 
housed at the project site.  These projects will be approved by the SC with 
advice from the external advisory committee.  


The mechanism of support for this RFA is the NIOSH U10 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 NIOSH staff being substantially involved as a partner 
with the Principal Investigator.  This relationship is described under the 
section "Cooperative Agreement Terms and Conditions of Award", below.  The 
project period for studies supported through this RFA will be 5 years.  The 
anticipated award date is March 15, 2004.

This RFA uses just-in-time concepts.  It does not use the modular budgeting 
formats.  Follow the instructions for a detailed budget research grant 
application.  This program does not require cost sharing as defined in the 
current NIH Grants Policy Statement at  
NIOSH intends to commit approximately $15 million annually over a 5-year 
period to the support of the World Trade Center Worker Health Study, (Total 
Costs include Direct Costs and Facility & Administrative Costs, also called 
indirect costs or overhead).  It is anticipated that four to eight CCs and two 
DCCs will be established under this program.  Approximately $5 million each 
year will be committed to the fire fighter CC and DCC and $10 million to the 
other responder CCs and DCC. The proposed direct cost budget of a CC should 
not exceed $300,000 plus capitation. As the number of patients to be seen is 
uncertain, an applicant should only state a proposed capitation rate and 
number of patients projected.  NIOSH and the CDC Procurement and Grants Office 
will determine the amount for capitation. The proposed budget of a DCC 
applicant may not exceed $1,000,000 Direct Costs in the first year, and 
$750,000 in the subsequent years.  Applications exceeding the funding limits 
detailed above in any year will be considered unresponsive and returned 
without further consideration. Specific instructions for budget preparation 
are in the SUPPLEMENTAL INSTRUCTIONS, below.  Designated funding levels are 
subject to change at any time prior to award due to unforeseen budgetary, 
administrative, or scientific developments.  At this time, NIOSH does not plan 
to reissue this RFA.

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 institutions/organizations
o Faith-based and community based organizations 
o Indian Tribes, Tribal Government, College and/or Organizations

Foreign institutions are not eligible to apply.  An institution may apply for 
both a CC and the DCC, but there must be minimal overlap of key personnel to 
ensure that data acquisition is independent of data quality assurance and 
analysis.  Therefore, the principal investigators for a CC and DCC must be 
different.  The application for the DCC must be separate and independent from 
the CC application.  

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to develop 
an application for support.  Women, individuals in underrepresented racial and 
ethnic groups, and individuals with disabilities are always encouraged to 
apply for NIOSH programs.  

The WTCRHC will be a collaborative effort that will require frequent 
interactions of awardees among themselves and with NIOSH.  Applicants should 
explicitly indicate their willingness to 

o  Participate in Steering Committee meetings (expected to occur approximately 
three to six times per year in or near New York, NY), site visits required by 
NIOSH, and regular telephone conference calls,
o  Cooperate with the Clinical Coordinators in the development and design of 
health assessment protocols (however, it is anticipated that there may be some 
differences between the firefighter responder and other responder protocols),
o  Abide by common definitions; common methods for patient selection 
and enrollment; and common protocols (as appropriate), procedures, tests, and 
reporting forms as chosen by majority vote of the Steering Committee or 
Executive Committee (however, it is anticipated that there may be some 
differences between the firefighter responder and other responder protocols), 
o  Actively seek to implement approved protocols,
o  Comply with study policies and quality assurance measures,
o  Agree to the oversight of the study in collaboration with the NIOSH 
Scientific Program Administrator,
o  Accept awards for the support of clinical assessments based on per-patient 
(capitated) rates and the actual numbers of patients served. (CCs only),
o  Transmit study data to a DCC in a timely and accurate manner (CCs only),
o  Report all adverse events in accordance with procedures established 
by the Steering Committee and NIOSH policies to the DSMB,
o  Cooperate with other awardees in the publication of study results 
and the eventual release to the scientific community of study 
procedures and other resources, 
o  Develop and implement plans for the dissemination of study results 
to physicians involved in the care of World Trade Center workers and 
volunteers from the September 11, 2003 event, and
o  Accept the Cooperative Agreement Terms and Conditions of Award given 

Cooperative Agreement Terms and Conditions of Award

The cooperative agreement is an award instrument establishing an "assistance" 
relationship (in contrast to an "acquisition" relationship) between NIOSH and 
a recipient, in which substantial NIOSH scientific and/or programmatic 
involvement with the recipient is anticipated during performance of the 
activity.  The purpose of NIOSH involvement is to support and/or stimulate the 
recipient's activity by acting as a "partner", while avoiding a dominant role, 
direction, or prime responsibility.  The terms and conditions below, elaborate 
on these actions and responsibilities, and the awardee agrees to these 
collaborative actions with the NIOSH Scientific Program Administrator to 
achieve the project objectives.  It is anticipated that these terms and 
conditions will enhance the relationship between the NIOSH staff and the 
principal investigator(s), and will facilitate the successful conduct and 
completion of the study.  These agreements will be in addition to, and not in 
lieu of, the relevant NIOSH procedures for grants administration. 

The terms will be as follows:
1.  The awardee(s) will have lead responsibilities in all aspects of the 
study, including any modification of study design, conduct of the study, 
quality control, data analysis and interpretation, preparation of 
publications, and collaboration with other investigators, unless otherwise 
provided for in these terms or by action of the Steering Committee.
2.  The NIOSH Scientific Program Administrator will serve on the Steering 
Committee as non-voting members; he/she or other NIOSH scientists may serve on 
other study committees, when appropriate, but if other NIOSH scientists are 
identified, they will also be non-voting members. The NIOSH Scientific 
Program Administrator (and other NIOSH scientists) may work with 
awardees on issues coming before the Steering Committee and, as appropriate, 
other committees, e.g., recruitment, intervention, follow-up, quality control, 
adherence to protocol, assessment of problems affecting the study and possible 
changes in protocol, interim data and safety monitoring, final data analysis 
and interpretation, preparation of publications, and development of solutions 
to major problems such as insufficient participant enrollment.
3.  Awardee(s) agree to the governance of the study through a Steering 
Committee.  Steering Committee voting membership shall consist of the 
Principal Investigators (i.e., cooperative agreement awardees), and the 
Chairperson.  Meetings of the Steering Committee will ordinarily be held by 
telephone conference call or in the metropolitan New York Area.
4.  Awardees will retain custody of and have primary rights to their data     
consistent with current HHS, PHS, and NIOSH policies.  The collaborative 
protocol and governance policies will call for the continued submission of 
data centrally to the coordinating centers for collaborative databases, one 
for the firefighter and one for the other responder cohort; the submittal of 
copies of the collaborative datasets to each principal investigator upon 
completion of the study; procedures for data analysis, reporting and 
publication; and procedures to protect and ensure the privacy of medical and 
genetic data and records of individuals.  The NIOSH Scientific Program 
Administrator on behalf of NIOSH, will have the same access, privileges and 
responsibilities regarding the collaborative data as the other members of the 
Steering Committee.
5.  Awardees are encouraged to publish and to publicly release and disseminate 
results, data and other products of the study, concordant with study protocols 
and governance, and the approved plan for making data and materials available 
to the scientific community and to NIOSH.  
6.  The NIOSH reserves the right to terminate or curtail the study (or an 
individual award) in the event of (a) failure to develop or implement a 
mutually agreeable collaborative protocol, (b) substantial shortfall in 
participant recruitment, follow-up, data reporting, or quality control, (c) 
major breach of the protocol or substantive changes in the agreed-upon 
protocol with which NIOSH cannot concur, or (d) human subject ethical issues 
that may dictate a premature termination.
7.  These special terms of award are in addition to and not in lieu of 
otherwise applicable OMB administrative guidelines, HHS Grant 
Administration Regulations at 45 CFR part 74 and 92, and other HHS, PHS, CDC 
NIOSH grant administration policy statements.


We encourage inquiries concerning this RFA and welcome the opportunity to 
answer questions from potential applicants. Inquiries may fall into three 
areas: scientific/research, peer review, and financial or grants management 

o Direct your questions about scientific/health assessment issues to:

Michael J. Galvin Jr., Ph.D.
Scientific Program Administrator
Office of Extramural Programs
Centers for Disease Control and Prevention
National Institute for Occupational Safety and Health
1600 Clifton Road, N.E.
Building 24, Room 1537, MS E-74
Atlanta, GA  30333
Telephone:  (404) 498-2524
FAX:  (404) 498-2571

o Direct your questions about peer review issues to:

Pervis C. Major, Ph.D.
Scientific Review Administrator
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention (CDC)
1095 Willowdale Rd
Morgantown, WV 26505
Telephone 304-285-5979
Fax 304-285-6147

o Direct inquiries about financial or grants management matters to:

Mr. John Columbia, Contract Specialist
Acquisition and Assistance Field Branch
Centers for Disease Control and Prevention 
626 Cochrans Mill Road
Pittsburgh, Pennsylvania 15236-0070
Announcement Number OH-04-001
Telephone:  (412) 386-4458


Prospective applicants are asked to submit a letter of intent that includes 
the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA

Although a letter of intent is not required, is not binding, and does not 
enter into the review of an application, the information that it contains is 
used to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this 
document and should be sent to: 

Pervis C. Major, Ph.D.
Scientific Review Administrator
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention (CDC)
1095 Willowdale Rd
Morgantown, WV 26505
Telephone 304-285-5979
Fax 304-285-6147


Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001). Applications must have a DUN and 
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the 
Universal Identifier when applying for Federal grants or cooperative 
agreements. The DUNS number can be obtained by calling (866) 705-5711 or 
through the web site at The DUNS number 
should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 
document is available at in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 710-0267, 


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. 

Supplemental Instructions for the Data and Coordinating Center:

Applicants for the Data and Coordinating Center should address the potential 
requirements of the CCs, and how they would be satisfied by the DCC.

Plans for collection and handling of data consistent with the projected needs 
of the study sites should be discussed.  Plans for ensuring data integrity and 
quality control should be discussed.

Personnel: The application for a DCC must describe the expertise of key 
scientific, technical and administrative personnel and include a mechanism for 
replacing key professional or technical personnel should the need arise. The 
Principal Investigator of the DCC should be a professional with experience in 
directing a coordinating center for large-scale collaborative multi-site 
clinical studies or other large-scale epidemiological research project 
involving multiple institutions. Staff needs may be modified as the WTCRHC 
studies progress; however, adequate support staff should be designated to 
manage routine tasks:

o PI of the DCC should provide overall scientific and biostatistical guidance.

o Project Manager to attend to day-to-day details and communicate necessary 
information to study sites and/or to the other WTCRHC organizational 
components. Staff training is also a responsibility of the Project Manager.

o Statisticians to help in data analysis.

o System analysts to help with developing and managing the database programs.

o Computer programmers to develop computer database.

o Clerks and administrative assistants to help in administrative work 
and data entry.

Budget:  The budgets for the DCC application should be based 
on the applicant's best judgment of activities likely to be involved during 
the different Phases of the WTCRHC studies. 

The Phase 1 budget (Year 1) should include costs of establishing the 
DCC staff, as required to carry out the DCC functions (including costs of 
training personnel of CC sites for management and analyses, and quality 
control and quality assurance of common data).  Phase 1 also will involve 
development of the protocols and manuals of operations by the CC sites, in 
conjunction with the Steering Committee for the CC studies and creation of a 
database for the common measures between the CC sites. 

During Phase 2, the budgets should include projected data handling costs, 
reporting functions, meetings and other communications costs, and the 
projected expense of performing any interim analyses that may be requested by 
the DSMB.  Budgets should also include costs of organizing three joint 
meetings of the Steering and External Advisory Committees per year and 
providing for attendance of necessary Data and Coordinating Center staff.  For 
planning purposes, the applicant should assume no travel expenses for the 
Steering committee, and $5,000 per meeting for the External Advisory Committee 
travel expenses.

The Phase 3 (Year 5) budget should be concerned with study closeout, analysis 
of study data, and reporting of results in collaboration with the study sites. 
Budgets should also include costs of organizing three joint meetings of the 
Steering and External Advisory Committees

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:

SENDING AN APPLICATION TO NIOSH: Submit a signed, typewritten original of the 
application, including the Checklist, and three signed photocopies, in one 
package to:  

Center for Scientific Review (CSR)
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

At the time of submission, two additional copies of the application and all 
copies of appendix material must also be sent to:

Pervis C. Major, Ph.D.
Scientific Review Administrator
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention (CDC)
1095 Willowdale Rd
Morgantown, WV 26505
Telephone 304-285-5979
Fax 304-285-6147

APPLICATION PROCESSING: Applications must be received by the application 
receipt date listed in the heading of the RFA.  If an application is received 
after that date, it will be returned to the applicant without review.  

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.

The Center for Scientific Review (CSR) 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 from the 
previous unfunded version of the application.  


Upon receipt, applications will be reviewed for completeness by CSR and 
responsiveness by NIOSH.  Incomplete applications will not be reviewed.

If the application is not responsive to the RFA, NIOSH staff may contact the 
applicant to determine whether to return the application to the applicant or 
submit it for review in competition with unsolicited applications at the next 
appropriate NIH review cycle.

Applications that are complete and responsive to the RFA will be evaluated for 
scientific and technical merit by a scientific review group convened by NIOSH 
in accordance with the review criteria stated below.  As part of the initial 
merit review, all applications will:

o Undergo a process in which only those applicants deemed to have the highest 
scientific or technical merit, generally the top half of the applications 
under review, will be discussed and assigned a priority score.
o Receive a written critique.
o Receive a second level of review by the NIOSH Secondary Review Committee.


The goals of NIOSH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to evaluate the application in 
order to judge the likelihood that the proposed research will have a 
substantial impact on the pursuit of these goals. The scientific review group 
will address and consider each of the following criteria in assigning the 
application’s overall score, weighting them as appropriate for each 

o Significance
o Approach
o Innovation
o Investigator
o Environment

The application does not need to be strong in all categories to be judged 
likely to have major scientific impact and thus deserve a high priority score. 
For example it may propose to carry out important work that by its nature is 
not innovative but essential to move a field forward.

Clinical Center
Review Criteria for the Administrative Core/overall program are:

o  Responsiveness to the objectives of the cooperative agreement program, 
including the applicant's understanding of the objectives of the proposed 
cooperative agreement and the relevance of the proposal to the objectives. 

o  Feasibility of meeting the proposed goals of the cooperative agreement 

o  Degree to which the program design addresses the distinct characteristics, 
specific populations, and needs of the target population. 

o  Leadership ability and scientific stature of the Clinical Center Director 
and his/her ability to meet the program's demands of time and effort.

o  Effectiveness of the Center in establishing or continuing a health 
screening program for WTC responders. 

o  Institutional commitment to the Center.

Review Criteria for the Clinical Core are:

SIGNIFICANCE:  Does your study address an important problem? If the aims of 
your application are achieved, how do they advance scientific knowledge?  
What will be the effect of these studies on the concepts or methods that drive 
this field?

The final design of the protocols (site-specific and common) will be developed 
collaboratively by the CC sites and the Steering Committee. In assessing 
applications for the Clinical Center, the scientific review group will focus 
on whether the applicant recognizes the significance of the issues involved 
and has the knowledge necessary to contribute meaningfully to the final 
design, including understanding of the scientific, ethical, and practical 
issues underlying the studies.

APPROACH:  Does the applicant provide evidence of cooperation with the target 
population?  Does the applicant have demonstrated support from and experience 
with the target population? Are the conceptual framework, design, methods, and 
analyses adequately developed, well integrated, and appropriate to the aims of 
the project?  Do you acknowledge potential problem areas and consider 
alternative tactics? Did the applicant fully describe the health screening 
model and provide the capitation rate that their CC would require their model? 
Does the applicant have an appropriate patient referral program for patients 
who require medical follow-up? Does the applicant describe a reasonable health 
screening model for the target population?  Does the applicant address patient 
confidentiality and data security?  Does the applicant propose appropriate 
health screening approaches?  

INNOVATION:  Does your project employ novel concepts, approaches or methods? 
Is the health screening design innovative and efficient?  Does the project 
challenge existing paradigms or develop new methodologies or technologies?  
Does the proposal address problems that may arise during the study and provide 
innovative solutions to such problems?  

INVESTIGATOR: Is the principal investigator appropriately trained and well 
suited to carry out this work?  Does the investigator team have experience 
working with World Trade Center Responders? Is the work proposed appropriate 
to the experience level of the principal investigator and to that of other 
researchers?  Does the application provide evidence of specific competence and 
relevant experience of professional, technical, and administrative staff 
pertinent to the operation of a Clinical Center for multi-site studies?  Prior 
experience collecting patient data and should be demonstrated. Does the PI 
have appropriate clinical experience to conduct the study? Is there evidence 
of experience in and willingness to participate appropriately in a 
collaborative study as described in this RFA? Are there adequate assurances 
that the Clinical Center personnel have experience in utilizing procedures 
that insure the safety and confidentiality of medical records?  

ENVIRONMENT:  Does the scientific environment in which the work will be done 
contribute to the probability of success? Do the proposed protocols take 
advantage of unique features of the scientific environment or employ useful 
collaborative arrangements? Is there evidence of institutional support? Has 
the application documented the adequacy of the proposed facility, technical 
hardware, and working relationship with a DCC?  Evidence of institutional 
support and commitment for the proposed program should be provided.

RECRUITMENT EXPERIENCE AND CAPABILITIES:  What is the likelihood, based on 
experience and patient base, that the PI will be successful in recruiting an 
adequate number of responders with the desired clinical characteristics and 
with an acceptable level of participation by women and individuals from racial 
and ethnic minority populations?  Does the CC have experience with the target 

Review Criteria for the Data and Coordination Center are:
SIGNIFICANCE:  Does the study address an important problem? If the aims of 
your application are achieved, how do they advance scientific knowledge?  What 
will be the effect of these studies on the concepts or methods that drive this 

APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project?  Did the investigator acknowledge potential problem areas and 
consider alternative tactics? Does the proposed approach in managing the 
logistical and data coordination have scientific and technical merit? Are the 
proposed plans and experience relating to data collection, management, 
editing, processing, analysis, and reporting adequate? Are the plans for 
coordination with the study site investigators adequate? Is the approach to 
developing a cooperative relationship among the study sites and between the 
various WTCRHC organizational components adequate? Are the plans for 
exercising appropriate leadership in matters of study design, data 
acquisition, data management, and data analysis demonstrated?

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 for health data 
management?  Does the applicant for the DCC Center offer innovative ideas on 
how to achieve the goals of the WTCRHC studies with regard to its design and 

INVESTIGATORS:  Is the principal investigator appropriately trained and well 
suited to carry out this work?  Does the principal investigator have 
experience in directing a DCC for large-scale collaborative multi-site 
clinical studies or other large-scale epidemiological research project 
involving multiple institutions?  Are the other members of the DCC appropriate 
for the scope of work proposed?

ENVIRONMENT:  Does the scientific environment in which your work will be done 
contribute to the probability of success?  Do the proposed protocols take 
advantage of unique features of the scientific environment or employ useful 
collaborative arrangements?  Is there an appropriate organizational and 
administrative structure to the proposed DCC?  Is there evidence of 
institutional support?

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:

Scientific Review Criteria

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).

to include subjects from all genders, all racial and ethnic groups (and 
subgroups), and children as appropriate for the scientific goals of the 
research will be assessed.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the sections on 
Federal Citations, below).
(CCs only)

DATA SHARING:  The adequacy of the proposed plans to share data and 
disseminate study results. 

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

Programmatic Review Criteria

o Experience with the target population.
o Size of target population likely to be captured.
o Geographic area and target population served.

Letter of Intent Receipt Date: December 22, 2003
Application Receipt Date: January 23, 2004
Earliest Anticipated Start Date: March 15, 2004


Award criteria that will be used to make award decisions include:

o Scientific merit
o Availability of funds
o Programmatic priorities
o Geographic balance


HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks of 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.

DATA AND SAFETY MONITORING PLAN:  Data and safety monitoring is required for 
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I), efficacy studies (phase II), efficacy, 
effectiveness and comparative trials (phase III). The establishment of data 
and safety monitoring boards (DSMBs) is required for multi-site clinical 
trials involving interventions that entail potential risk to the participants. 
NIOSH follows the NIH Policy for Data Safety and Monitoring, NIH Guide for 
Grants and Contracts, June 12, 1998:  

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, and NIOSH adheres to this policy.

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 
a complete copy of the updated Guidelines are available at

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 

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.  For this announcement NIOSH follows this policy. 

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 

policy requires education on the protection of human subject participants for 
al investigators submitting NIOSH 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

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

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.

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 
( 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

for NIOSH 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 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 HHS 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.

HEALTHY PEOPLE 2010: CDC is committed to achieving the health promotion and 
disease prevention objectives of "Healthy People 2010," a national activity 
for reducing morbidity and mortality and 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"

AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal 
Domestic Assistance at and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. And under 
the Occupational Safety and Health Act of 1970, Section 20(a) (29 USC 669(a)).

All awards are subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement.  The NIH Grants 
Policy Statement can be found at 

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the use of all tobacco products.  In addition, Public 
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain 
facilities (or in some cases, any portion of a facility) in which regular or 
routine education, library, day care, health care, or early childhood 
development services are provided to children.  This is consistent with the 
PHS mission to protect and advance the physical and mental health of the 
American people.

Return to Volume Index

Return to NIH Guide Main Index

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

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