RELEASE DATE:  September 30, 2003

PA NUMBER:  PA-03-178 (This PA has been suspended, see NOT-LM-05-016)
                      (Peer Review contact change, see NOT-LM-05-007)

EXPIRATION DATE:  November 30, 2005

Department of Health and Human Services (DHHS)


National Institutes of Health (NIH)


National Library of Medicine (NLM)
National Institute of Mental Health (NIMH)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)

(NIMH); 93.286 (NIBIB)


o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

The National Library of Medicine, the National Institute of Mental 
Health, and the National Institute of Biomedical Imaging and 
Bioengineering wish to support informatics research that addresses 
biomedical information management problems relevant to management of 
disasters. Disasters can be caused by nature or by man, through 
accident or by malice. Terrorism, particularly bioterrorism, is now an 
important focus of federal activity, but terrorism is only one of a 
number of threats to public safety classified as disasters. Disaster 
management is heavily dependent on efficient flow of information and 
extraction of critical knowledge. How best to utilize information 
technology in a disaster situation poses a number of problems for which 
relevant informatics research is necessary. This PA replaces PAR-02-137 
Informatics For Disaster Management, which utilized the R01 mechanism 
rather than the R21 mechanism in effect in this PA.      


The Federal Emergency Management Agency (FEMA) classifies disasters as 
Natural (e.g. earthquakes, hurricanes, floods, wildlife fires etc.) or 
Technological (e.g. terrorism, nuclear power plant emergencies, 
hazardous materials etc.). Other classification schemes exist, but 
whatever the cause, certain features are desirable for management of  
almost all disasters:

o Prevention 
o Advance warning 
o Early detection 
o Analysis of the problem, and assessment of scope
o Notification of the public and appropriate authorities
o Mobilization of a response
o Containment of damage
o Relief and medical care for those affected

Because efficient realization of these elements is heavily dependent on 
adequate and timely flow of information and knowledge, appropriate use 
of modern information technology can be of enormous help to those 
responsible for disaster management. How best to use the information 
systems in place, and how to improve their contribution to disaster 
management are the concerns of this PA.

Some informatics issues relevant for disaster management include, among 

o Standards to permit collection of data from diverse sources
o Coordination of disparate information systems across jurisdictional 
boundaries, and among system owners
o Design and deployment of appropriate databases for assessment of 
impact pre- and post-disaster 
o Current, accurate information for clinicians and public
o Decision support systems for diagnosis and treatment
o Pattern recognition, data mining, and knowledge extraction algorithms
o Preserving privacy while protecting the public
o Pre- and post-disaster tracking systems for response personnel, 
disaster victims, and other resources
o Timely mobilization (including prior or standing IRB approval)

For the most part these are the same issues that have interested 
informaticians during the past decade with considerable success for 
clinical information systems. However, specific solutions are needed 
within the context of disaster management.  Universal installation of 
electronic medical record systems and physician order entry would 
doubtless provide multiple benefits; however, such systems are not 
likely to be widely in place in the near future. Solutions are needed 
that can utilize or incrementally improve the health care information 
systems of today. This PA is intended to encourage applications that 
seek such solutions.

Within this area, NIMH is particularly interested in encouraging 
researchers to develop and test data collection technologies and 
procedures that will speed and coordinate the process of acquiring and 
utilizing new information about mental health consequences of 
disasters.   The development and testing of approaches for computerized 
patient triage and tracking systems, coordination of databases and 
survivor registries, data storage and confidentiality procedures, and 
environmental stress/damage assessments are examples of the types of 
projects that can help to gather, manage, and disseminate mental health 
relevant information in a disaster situation.   Such information may: 
improve long-term survival, help prepare for subsequent incidents, aid 
in assessing the physical and emotional needs of a population, impact 
on planning and provision of mental health services for victims and 
other disaster-affected persons, and increase understanding of the 
human response to trauma more broadly.

The NIBIB supports hypothesis-, design-, technology- or problem-driven 
research relating to the discovery, design, development, translation, 
application, and assessment of new knowledge in biomedical imaging and 
bioengineering.  In the context of disaster management NIBIB is 
interested in (i) technologies related to data reduction, data mining, 
and knowledge extraction; (ii) the enhancement of the utility of 
existing databases by development of tools for meta-databases and 
integrative services; and (iii) methods for timely, appropriate 
communication of pertinent knowledge to cognizant bodies.


This PA will use the NIH R21 award mechanism 
(  As an 
applicant, you will be solely responsible for planning, directing, and 
executing the proposed project. 

The evolution and vitality of informatics for disaster management 
requires a constant infusion of new ideas, techniques, and points of 
view.  These may differ substantially from current thinking or practice 
and may not yet be supported by substantial preliminary data.  By using 
the R21 mechanism, NLM, NIMH, and NIBIB seek to foster the introduction 
of novel scientific ideas, model systems, tools, agents, targets, and 
technologies that have the potential to substantially advance research 
in this area.

The R21 mechanism is intended to encourage new exploratory and 
developmental research projects.  For example, such projects could 
assess the feasibility of a novel area of investigation or a new 
experimental system that has the potential to enhance health-related 
research.  Another example is a project that could include the unique 
and innovative use of an existing methodology to explore a new 
scientific area. These studies may involve considerable risk but may 
lead to a breakthrough in a particular area, or to the development of 
novel techniques, agents, methodologies, models or applications that 
could have major impact on a field of biomedical, behavioral, or 
clinical research.

Applications for R21 awards should describe projects distinct from 
those supported through the traditional R01 mechanism.  For example, 
long-term projects, or projects designed to increase knowledge in a 
well-established area will not be considered for R21 awards.  
Applications submitted under this mechanism should be exploratory and 
novel.  These studies should break new ground or extend previous 
discoveries toward new directions or applications.   

The applicant may request a project period of up to 2 years with a 
combined budget for direct costs of up to $275,000 for the two year 
period. The request should be tailored to the needs of the project.  
Normally, no more than $200,000 may be requested in any single year.  

This PA uses just-in-time concepts.  It also uses the modular budgeting 
format. (see   
All applications submitted in response to this announcement must use 
the modular budget format.  This program does not require cost sharing 
as defined in the current NIH Grants Policy Statement at  

Exploratory/developmental grant support is for new projects only; 
competing continuation applications will not be accepted.   Two 
revisions of a previously reviewed exploratory/developmental grant 
application may be submitted as defined in NIH Policy at


Applications may be submitted by institution with any of the following 
o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, 
hospitals, and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic or foreign institutions/organizations
o Faith-based or community-based organizations 


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.  Individuals from 
underrepresented racial and ethnic groups as well as individuals with 
disabilities are always encouraged to apply for NIH programs.   


We encourage your inquiries concerning this PA and welcome the 
opportunity to answer questions from potential applicants.  Inquiries 
may fall into two areas:  scientific/research and financial or grants 
management issues:

o Direct your questions about NLM scientific/research interests to:

Valerie Florance, PhD
Extramural Programs
National Library of Medicine
6705 Rockledge Drive, Suite 301 
Bethesda, MD  20892
Telephone:  (301) 594-4882
FAX:  301 402-2952

o Direct your questions about NIMH scientific/research issues:

Farris Tuma, Sc.D.
Traumatic Stress Research Program 
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6197, MSC 9617
Bethesda, MD  20892-9617
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 443-5944
FAX:  (301) 480-5514

O Direct your questions about NIBIB scientific/research issues:

Peter M. Lyster, PhD
Program Director
Division of Discovery Science & Technology
National Institute of Biomedical Imaging and Bioengineering
National Institutes of Health, DHHS
6707 Democracy Bvd. Suite 200
Bethesda, MD  20892-5469
(301)480-1614 FAX

o Direct your questions about NLM financial or grants management 
matters to:

Dwight Mowery
Extramural Programs
National Library of Medicine
Rockledge 1, Suite 301, 6705 Rockledge Drive
Bethesda, MD  20892
Telephone:  (301) 496-4221
FAX:  (301) 402-0421

Direct your questions about NIMH financial or grants management matters 

Brian Albertini 
Grants Management Branch
National Institute of Mental Health 
6001 Executive Boulevard, Room 6115, MSC 9605 
Bethesda, MD  20892-9605 
Telephone:  (301) 443-0004 
FAX:  (301) 443-0219 

Direct your questions about NIBIB financial or grants management 
matters to:
Ms. Nancy Curling
Division of Extramural Activities
National Institute of Biomedical Imaging and Bioengineering
Suite 900
6707 Democracy Blvd. 
Bethesda, MD  20892
Telephone:  (301) 451-4782
Fax:  301-480-4974


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 is available 
at in an 
interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 710-0267, Email:

APPLICATION RECEIPT DATES: Applications submitted in response to this 
program announcement will be accepted at the standard application 
deadlines, which are available at  Application deadlines are also 
indicated in the PHS 398 application kit.

SUPPLEMENTARY INSTRUCTIONS:  All instructions for the PHS 398 (rev. 
5/2001) must be followed, with these exceptions:

Research Plan. Items a - d of the Research Plan (Specific Aims, 
Background and Significance, Preliminary Studies, and Research Design 
and Methods) may not exceed a total of 15 pages.  No preliminary data 
are required but may be included if available.  

Appendix.  Use the instructions for the appendix detailed in the PHS 
398 except that no more than 5 publications or manuscripts accepted for 
publication may be included. 

initiated R21 applications must be submitted in a modular grant format.  
The modular grant format simplifies the preparation of the budget in 
these applications by limiting the level of budgetary detail.  
Applicants request direct costs in $25,000 modules.  Section C of the 
research grant application instructions for the PHS 398 (rev. 5/2001) 
at includes 
step-by-step guidance for preparing modular grants.  Additional 
information on modular grants is available at

For the NIH Exploratory/Developmental Grant (R21), applicants may 
request direct costs in $25,000 modules, up to a total direct cost of 
$275,000 for the combined two year award period.      

SENDING AN APPLICATION TO THE NIH:  Submit a signed, typewritten 
original of the application, including the checklist, and five signed 
photocopies in one package to:

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

APPLICATION PROCESSING: Applications must be mailed on or before the 
receipt dates described at  The CSR 
will not accept any application in response to this PA that is 
essentially the same as one currently pending initial review unless the 
applicant withdraws the pending application.  The CSR 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 
R21 application already reviewed, but such application must include an 
Introduction addressing the previous critique.

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.


Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  Appropriate scientific review 
groups convened in accordance with the standard NIH peer review 
procedures ( will evaluate 
applications for scientific and technical merit.  

As part of the initial merit review, all applications will:

o Undergo a selection process in which only those applications deemed 
to have the highest scientific merit, generally the top half of 
applications under review, will be discussed and assigned a priority 
o Receive a written critique
o Receive a second level review by the appropriate national advisory 
council or board        


The goals of NIH-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 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.  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.    

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, you may propose to carry out important 
work that by its nature is not innovative but is essential to move a 
field forward.

(1) SIGNIFICANCE:  Does the study address an important problem? If the 
aims of the 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?

(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 alternative tactics?

(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 

(4) INVESTIGATOR: Is the investigator appropriately trained and well 
suited to carry out this work? Is the work proposed appropriate to the 
experience level of the principal investigator and other researchers 
(if any)?

(5) ENVIRONMENT:  Does the scientific environment in which your work 
will be done contribute to the probability of success? Do the proposed 
experiments take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements?  Is there 
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:

The NIH R21 exploratory/developmental grant is a mechanism for 
supporting novel scientific ideas or new model systems, tools or 
technologies that have the potential to significantly advance our 
knowledge or the status of health- related research.  Because the 
research plan is limited to 15 pages, an exploratory/developmental 
grant application need not have extensive background material or 
preliminary information as one might normally expect in an R01 
application.  Accordingly, reviewers will focus their evaluation on the 
conceptual framework, the level of innovation, and the potential to 
significantly advance our knowledge or understanding.  Reviewers will 
place less emphasis on methodological details and certain indicators 
traditionally used in evaluating the scientific merit of R01 
applications including supportive preliminary data. Appropriate 
justification for the proposed work can be provided through literature 
citations, data from other sources, or, when available, from 
investigator-generated data.  Preliminary data are not required for R21 

human subjects and protections from research risk relating to their 
participation in the proposed research will be assessed. (See criteria 
included in the section on Federal Citations, below).
of plans to include subjects from both genders, all racial and ethnic 
groups (and subgroups), and children as appropriate for the scientific 
goals of the research will be assessed.  Plans for the recruitment and 
retention of subjects will also be evaluated. (See Inclusion Criteria 
in the sections on Federal Citations, below).


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


Applications submitted in response to a PA will compete for available 
funds with all other recommended applications.  The following will be 
considered in making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities


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

policy of the NIH that women and members of minority groups and their 
sub-populations must be included in all NIH-supported clinical research 
projects unless a clear and compelling justification is provided 
indicating that inclusion is inappropriate with respect to the health 
of the subjects or the purpose of the research. This policy results 
from the NIH Revitalization Act of 1993 (Section 492B of Public Law 

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 differences.

SUBJECTS: The NIH maintains a policy that children (i.e., individuals 
under the age of 21) must be included in all human subjects research, 
conducted or supported by the NIH, unless there are scientific and 
ethical reasons not to include them. This policy applies to all initial 
(Type 1) applications submitted for receipt dates after October 1, 

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 all investigators submitting NIH proposals for 
research involving human subjects.  You will find this policy 
announcement in the NIH Guide for Grants and Contracts Announcement, 
dated June 5, 2000, at 

The Office of Management and Budget (OMB) Circular A-110 has been 
revised to provide public access to research data through the Freedom 
of Information Act (FOIA) under some circumstances.  Data that are (1) 
first produced in a project that is supported in whole or in part with 
Federal funds and (2) cited publicly and officially by a Federal agency 
in support of an action that has the force and effect of law (i.e., a 
regulation) may be accessed through FOIA.  It is important for 
applicants to understand the basic scope of this amendment.  NIH has 
provided guidance at

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.

proposals for NIH funding must be self-contained within specified page 
limitations. Unless otherwise specified in an NIH solicitation, 
Internet addresses (URLs) should not be used to provide information 
necessary to the review because reviewers are under no obligation to 
view the Internet sites.   Furthermore, we caution reviewers that their 
anonymity may be compromised when they directly access an Internet 

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of 
"Healthy People 2010," a PHS-led national activity for setting priority 
areas. This PA is related to one or more of the priority areas. 
Potential applicants may obtain a copy of "Healthy People 2010" at

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at at No. 93.879  and 
is not subject to the intergovernmental review requirements of 
Executive Order 12372 or Health Systems Agency review.  Awards are made 
under authorization of Sections 301 and 405 of the Public Health 
Service Act as amended (42 USC 241 and 284) and administered under NIH 
grants policies described at and under Federal 
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  

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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

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
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