INNOVATIONS IN BIOMEDICAL COMPUTATIONAL SCIENCE AND TECHNOLOGY

RELEASE DATE:  April 17, 2003

PA NUMBER:   PAR-03-106 

EXPIRATION DATE: March 01, 2006 unless reissued. 

March 2, 2006 (NOT-OD-06-046) – Effective with the June 1, 2006 submission date, 
all R03, R21, R33 and R34 applications must be submitted through Grants.gov using 
the electronic SF424 (R&R) application. A replacement R21 (PAR-06-411) funding 
opportunity announcement have been issued for the submission date 
of June 1, 2006 and submission dates thereafter.

Additional updates:
-The R01 portion of this PA has been reissued, see PAR-06-410
-Correction of dates, see NOT-OD-03-044
-Contact change for programmatic issues, see NOT-GM-05-102
-See addendum NOT-RR-04-007 and NOT-GM-05-101


National Institute of General Medical Sciences (NIGMS)  (http://www.nigms.nih.gov/) 
National Cancer Institute (NCI)
 (http://www.nci.nih.gov/)
National Center for Research Resources (NCRR)
 (http://www.ncrr.nih.gov/)
National Eye Institute (NEI)
 (http://www.nei.nih.gov/)
National Human Genome Research Institute (NHGRI)
 (http://www.genome.gov/)
National Heart, Lung, and Blood Institute (NHLBI)
 (http://www.nhlbi.nih.gov/index.htm)
National Institute on Aging (NIA)
 (http://www.nia.nih.gov/)
National Institute of Alcohol Abuse and Alcoholism (NIAAA)
 (http://www.niaaa.nih.gov/)
National Institute of Allergy and Infectious Diseases (NIAID)
 (http://www.niaid.nih.gov/default.htm)
National Institute of Child Health and Human Development (NICHD)
 (http://www.nichd.nih.gov/)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
 (http://www.nibib.nih.gov/)
National Institute on Drug Abuse (NIDA)
 (http://www.nida.nih.gov/)
National Institute of Dental and Craniofacial Research (NIDCR)
 (http://www.nidr.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS)
 (http://www.niehs.nih.gov/)
National Institute of Mental Health (NIMH)
 (http://www.nimh.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS)
 (http://www.ninds.nih.gov/)
National Library of Medicine (NLM)
 (http://www.nlm.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 (http://www.niddk.nih.gov)  

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS 
93.394, 93.849

LETTER OF INTENT RECEIPT DATES: (See revised dates in NOT-OD-03-044)
May 24, 2003; September 24, 2003
January 24, 2004; May 24, 2004; September 24, 2004
January 24, 2005; May 24, 2005; September 24, 2005
January 24, 2006

APPLICATION RECEIPT DATES: (See revised dates in NOT-OD-03-044)
June 24, 2003; October 24, 2003
February 24, 2004; June 24, 2004; October 24, 2004
February 24, 2005; June 24, 2005; October 24, 2005
February 26, 2006

THIS PA CONTAINS THE FOLLOWING INFORMATION

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

PURPOSE OF THIS PA  

Participating Institutes and Centers of the National Institutes of Health 
(NIH) invite applications for innovative research in biomedical computational 
science and technology to promote the progress of biomedical research. 

There exists an expanding need to speed the progress of biomedical research 
through the power of computing to manage and analyze data and to model 
biological processes.  The NIH is interested in promoting research and 
developments in computational science and technology that will support rapid 
progress in areas of scientific opportunity in biomedical research.  As 
defined here, biomedical computing or biomedical information science and 
technology includes database design, graphical interfaces, querying 
approaches, data retrieval, data visualization and manipulation, data 
integration through the development of integrated analytical tools, and tools 
for electronic collaboration, as well as computational and mathematical 
research including the development of structural, functional, integrative, 
and analytical models and simulations. 

RESEARCH OBJECTIVES

Computing and computational tools have become increasingly important in 
enabling progress in biomedical research.  In recognition of the critical 
role computing and computer science will play in biomedical research, the NIH 
Director commissioned a Working Group on Biomedical Computing in June 1999.  
The result of the deliberations of the Working Group on Biomedical Computing 
was a report entitled "The Biomedical Information Science and Technology 
Initiative (BISTI)" which can be accessed at the following site: 
http://www.nih.gov/welcome/director/060399.htm.  A major recommendation of 
the BISTI is that the NIH should provide additional resources and incentives 
for basic research to provide adequate support for those who are inventing, 
refining, and applying the tools of biomedical computing.  The promotion of 
the interface of biomedical information science and technology with 
biomedical research should result in new digital and electronic tools that 
will have substantial impact on broad areas of biomedical research.

The Institutes and Centers of the NIH acknowledge the wisdom of this 
recommendation and are offering support through the current solicitation for 
fundamental research in biomedical information science and technology as well 
as for the development of new informatics, computational and mathematical 
tools and technologies. 

This solicitation targets support for fundamental research in biomedical 
computing science and technology as well as the development and application 
of new biocomputing tools or technologies for a particular area(s) of 
scientific opportunity in biomedical research. Programs may target one or 
multiple areas of biomedical computing that will enable progress in 
biomedical research.  Examples of data types that could be considered include 
but are not limited to genomic sequences, biomedical images, qualitative 
descriptors for health and social science, remote sensing and geospatial 
images, and chemical formulae.  Specific research areas solicited in 
informatics or computational science include but are not limited to:
o  Tools for data acquisition, archiving, querying, retrieval, visualization, 
integration and management
o  Platform-independent translational tools for data exchange and for 
promoting interoperability
o  Analytical and statistical tools for interpretation of large data sets
o  New models or simulations of complex biological processes (and the 
development of mathematical tools for these processes)

Areas of biomedical research likely to be critically dependent on 
biocomputing advances include but are not limited to:
o  Behavioral science
o  Biological rhythms
o  Biomedical imaging 
o  Cell biology
o  Demographic and social science
o  Developmental biology
o  Drug design at the molecular and cellular levels
o  Dynamic modeling of health, chronic disease, and disablement
o  Environmental science
o  Epidemiology
o  Genetics
o  Genomics
o  Immunology/inflammation
o  Medical genetics
o  Morphology
o  Neurobiology and cognitive science
o  Pharmacology
o  Physiology
o  Population biology
o  Structural biology
o  Substance abuse research
o  Surgery and virtual tools

Projects must span the interface of biomedical research and biomedical 
computational science and technology. Applicants will be expected to 
demonstrate fundamental understanding and adequate expertise in both the 
relevant areas of computational science and technology and biomedical 
research.  Cross-disciplinary collaborations are strongly encouraged.  Given 
the expanding needs in biomedical research for advances in a variety of areas 
of information science and technology, the approaches and technologies 
proposed under this announcement should ultimately be generalizable, 
scalable, extensible, and interoperable.  The projects should take into 
account the needs of the biomedical research community that will be the 
ultimate end users of the products of the research.  The projects should also 
address plans for ensuring the dissemination of useful products of the 
research, including approaches, technologies and tools, to the relevant 
research and user communities.  The informatics and computational research 
proposed should be future-oriented, fill an area of need or projected need, 
and seek to exceed the current state-of-the-art. 

MECHANISM(S) OF SUPPORT 

This PA will use the NIH Phased Innovation Award (R21/R33) and R01 award 
mechanisms.  The R21/R33 mechanism is designed specifically for those 
projects which lack sufficient preliminary results to demonstrate 
feasibility.  Applicants can also submit an R01 application, if feasibility 
can be documented, as described in the APPLICATION PROCEDURES section of this 
program announcement.  Applications for R21 support alone will not be 
accepted.  The R33 grant mechanism provides a second phase for the support of 
innovative exploratory research initiated under the R21 mechanism.  

The combined R21/R33 application offers two advantages over the regular 
application process:

1.  Single submission and evaluation of both the R21 and the R33 as one 
application.

2.  Minimal or no funding gap between R21 and R33.  The award of R33 funds 
will be based on program priorities, on the availability of funds and on 
successful completion of negotiated scientific milestones as determined by 
institute staff in the context of peer review recommendations.

To be eligible for the Phased Innovation Award, the R21 phase must include 
well-defined quantifiable milestones that will be used to judge the success 
of the proposed research, as well as a credible plan for the development of 
tools or technology for the R33 phase. The Phased Innovation Award must have 
a section labeled "Milestones" at the end of the Research Plan of the R21 
application.  This section must include well-defined quantifiable milestones 
for completion of the R21 part of the application, a discussion of the 
suitability of the proposed milestones for assessing the success in the R21 
phase, and a discussion of the implications of successful completion of these 
milestones for the proposed R33 study.

The total project period for an application in response to this PA may not 
exceed two years for the R21 phase of a combined application, three years for 
the R33 phase, and five years for a combined R21/R33 proposal.  R01 proposals 
may request up to five years. For combined R21/R33 applications, the R21 
phase may not exceed $100,000 direct costs per year.  R21 budgets can exceed 
this cap to accommodate F&A costs to subcontracts to the project.  Although 
the R33 phase of the R21/R33 application and R01 application have no official 
budgetary limit, applications requesting in excess of $500,000 direct costs 
in any single year of the grant period require prior approval before 
submission.  It is strongly recommended that applicants contact institute 
staff at an early stage of application development to convey critical 
information, such as potentially large budget requests or to discuss 
programmatic responsiveness of the proposed project.  Refer to the INQUIRIES 
sections of this program announcement for institute staff contacts.

This PA uses just-in-time concepts.  It also uses the modular as well as the 
non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  Specifically, if 
you are submitting an application with direct costs in each year of $250,000 
or less, use the modular format.  Otherwise follow the instructions for non-
modular research grant applications.  For R21/R33 applications which exceed 
$250,000 in any given year of the R33 phase, the R21 portion should be 
submitted with a modular budget and the R33 phase with a detailed budget.

Some NIH institutes and centers may have other grant mechanisms that could 
apply to biomedical computing projects.  Interested participants should 
contact the institute or center technical contact indicated in the "List of 
BISTI Contacts" located at the URL given in the INQUIRIES section of the 
announcement.

Through a separate program announcement, the participating Institutes and 
Centers of the NIH are inviting applications for SBIR and STTR support, 
focusing on the identical research areas as described in the RESEARCH 
OBJECTIVES section of this solicitation.  For the SBIR/STTR solicitation, the 
expedited NIH review and cost allowance policies and procedures will be 
identical to this PA.  Qualified applicants are strongly encouraged to 
consider responding to the SBIR/STTR program announcement.  SBIR and STTR 
application information is available on the Internet at: 
http://grants.nih.gov/grants/funding/sbir.htm.

Potential applicants who believe that they may be eligible for the SBIR/STTR 
award should consult the PHS SBIR; and STTR Omnibus Solicitation prior to 
discussions of their eligibility with NIH staff listed under INQUIRIES.

This PA will expire on the date indicated on the front of this solicitation.  
Awards will be administered under NIH grants policy as stated in the NIH 
Grants Policy Statement dated March 2001, 
http://grants.nih.gov/grants/policy/nihgps_2001/.

ELIGIBLE INSTITUTIONS 

You may submit (an) application(s) if your institution has any of the 
following characteristics: 

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic or foreign

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

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. 

SPECIAL REQUIREMENTS

DATA AND SOFTWARE SHARING:  Applicants should detail their plans for sharing 
data and distributing software developed under this initiative.

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity to 
answer questions from potential applicants.  

Inquiries or contacts concerning institute-specific should be directed to the 
NIH BISTI technical or financial contacts listed at the following Web site: 
http://www.bisti.nih.gov/phased-innovation-contacts.cfm.

These scientific contacts must also be used to obtain permission to submit 
applications that request more the $500,000 of direct costs in any year.

Direct more general questions regarding programmatic issues, and email letters
of intent, to:

Peter Lyster, Ph.D.
NIGMS 
45 Center Drive, Room 2AS.55k, MSC 6200 
Bethesda, MD 20892-6200 
TEL: 301-451-6446 
Email: lysterp@mail.nih.gov

Direct your questions about peer review issues to: 

Donald Schneider, Ph.D.
CSR
Rockledge 2/Room 4172, MSC 7806
6701 Rockledge Drive
Bethesda, MD  20892
Tel:  301-435-1727
Fax:  301-480-2327
Email:  ds39x@nih.gov

Direct your questions about scientific/research issues to:

Christian Ketchum, Ph.D. 
Program Director, Renal Physiology 
Division of Kidney, Urologic, and Hematologic Diseases 
National Institutes of Diabetes and Digestive and Kidney Diseases 
National Institutes of Health 
6707 Democracy Boulevard, Room 647 
Bethesda, MD 20892-5458 
Phone: 301-402-1411 
Fax: 301-480-3510 
E-mail: ck228s@nih.gov

Direct your questions about financial or grants management issues to:

Ms. Helen Y S Ling, Grants Management Specialist 
Grants Management Branch
Division of Extramural Activities
National Institutes of Diabetes, Digestive and Kidney Diseases
National Institutes of Health
6707 Democracy Boulevard, Room 732 
Bethesda, MD 20892
Phone: 301-594-8857 
Fax: 301-480-3504 
E-mail: hl12d@nih.gov 

LETTER OF INTENT

Prospective applicants are asked to submit by the dates listed at the 
beginning of this program announcement a letter of intent that includes a 
descriptive title of the proposed research, the name, address, and telephone 
number of the Principal Investigator, the identities of other key personnel 
and participating institutions, and the number and title of the PA in 
response to which the application may be submitted.  Although a letter of 
intent is not required, is not binding, and does not enter into the review of 
a subsequent application, the information that it contains allows NIH staff 
to estimate the potential review workload and avoid conflict of interest in 
the review.  The letter of intent is to be sent to the program contact listed 
under INQUIRIES.

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  They must be received by the dates 
given on the first page of this announcement.  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) 435-0714, 
Email: GrantsInfo@nih.gov.

SPECIFIC INSTRUCTIONS FOR PREPARING THE COMBINED R21/R33 PHASED INNOVATION 
AWARD APPLICATION

The R21/R33 Phased Innovation Award application must be submitted as a single 
application, with one face page.  Although it is submitted as a single 
application, it should be clearly organized into two phases.  To accomplish a 
clear distinction between the two phases, applicants are directed to complete 
Sections a, c and d of the Research Plan twice: one write-up of Sections a-d 
and milestones for the R21 phase and sections a, c and d again for the R33 
phase.  Section b, the significance section, need not be repeated if there is 
no change going from the R21 phase to the R33 phase.  The Form 398 Table of 
Contents should be modified to show sections a-d for each phase as well as 
the milestones.  There is a page limit of 25 pages for the composite a-d text 
(i.e., section a-d and milestones for the R21 and sections a-d for the R33 
phase must be all contained within the 25 page limit).

In preparing the R21/R33 application, investigators should consider the fact 
that applications will be assigned a single priority score.  Thus, clarity 
and completeness of the R21/R33 application with regard to specific goals and 
feasibility milestones for each phase are critical. The presentation of 
milestones that are not sufficiently scientifically rigorous to be valid for 
assessing progress in the R21 phase will reflect upon the scientific judgment 
of the applicant. 

1.  Face Page of the application

Item 2.  Check the box marked "YES" and type the number and title of this 
program announcement.  Also indicate if the application is a R21/33 or R01.

Item 7a. Direct Costs Requested for Initial Period of Support

For the R21 phase of the combined R21/R33 application, direct costs are 
limited to a maximum of $100,000 per year for a maximum of two years and the 
award may not be used to supplement an ongoing project.  The requested 
budgets can exceed this cap to accommodate for F&A costs to subcontracts to 
the project.  Insert the first year of R21 support in item 7a, DIRECT COSTS 
REQUESTED FOR PROPOSED PERIOD OF SUPPORT.

For the R21 phase, direct costs requested for the proposed period may not 
exceed $200,000 for two years of support.  The statement in item 7a above 
pertaining to subcontract costs also applies here.  Insert the sum of all 
years of requested support in item 8a.

2.  Page 2 - Description

As part of the description, identify concisely the fundamental research 
and/or technology or tool to be developed, its innovative nature, its 
relationship to presently available capabilities, and its expected impact on 
biomedical information science and technology and biomedical research.

3.  Research Plan

For applications submitted for the R21/R33 mechanism the following should be 
included:

Item a: Specific Aims

This section should answer the question, "what specifically will be done 
during the proposed funding period?"  The applicant must present specific 
aims that he/she considers to be scientifically appropriate for the relevant 
phases of the project.

For applications that are submitted in response to this PA, research that 
develops new fundamental understanding, technologies, or tools is likely to 
require the application of principles of fields such as computer science, 
mathematics, and engineering.  Clear statements of these underlying 
principles within this section are essential.

Item b: Background and Significance

This section should answer the question, "why is the proposed research 
important?"  Elaborate on the innovative nature of the proposed research.  
Clarify how the fundamental research or tools or technologies to be developed 
as proposed in this project will result in a significant improvement over 
existing approaches.  Explain the potential of the proposed technology for 
having a broad impact on a compelling area of biomedical research.  Clearly 
identify how the project, if successful, would result in new capabilities for 
research, the immediacy of the opportunity, and how any proposed technologies 
or tools would differ from existing technologies or tools.

Item c: Preliminary Studies/Progress Report

This section should answer the question, "what have you done to demonstrate 
the feasibility of the proposed research?"  While preliminary data are not 
required or expected for submission of the R21 phase, this section should 
provide current thinking or evidence in the field to substantiate feasibility 
of the R21 phase.  The R33 need not repeat information already provided in 
the R21.  

Item d: Research Design and Methods

This section should answer the question, "how will the specific aims be 
accomplished?"  Follow the instructions in the PHS 398 booklet.  For this 
particular program, the applicant should also address plans to make the 
products, tools, or technologies forthcoming from this research available to 
the relevant biomedical research user community.  In addition, for the R21 
phase only, the following information must be included as a final section of 
Item d:

Applications must include a specific section labeled Milestones following the 
Research Design and Methods of the R21 phase.  Milestones should be well 
described, quantifiable, and scientifically justified and not be simply a 
restatement of the specific aims.  A discussion of the milestones relative to 
the success of the R21 phase, as well as the implications of successful 
completion of the milestones for the R33 phase and the page number of the 
milestones section should be listed.  This section should be indicated in the 
Table of Contents. 

Applications lacking this information as determined by the Institute program 
staff, will be returned to the applicant without review.  For funded 
applications, completion of the R21 milestones will elicit an Institute 
expedited review that will determine whether or not the R33 should be 
awarded. The release of R33 funds will be based on successful completion of 
milestones, program priorities and on the availability of funds.  The 
expedited review may result in additional negotiations of award.

SPECIFIC INSTRUCTIONS FOR PREPARATION OF THE R01 

Applications for R01 grants are to be submitted on the grant application form 
PHS 398 (rev. 5/2001) and prepared according to the instructions provided 
unless specified otherwise within items 1-5 below.  Application kits are 
available at most institutional offices of sponsored research and may be 
obtained from the Division of Extramural Outreach and Information Resources, 
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-
0714, email:grantsinfo@nih.gov.

1.  Face Page of the application

Item 2.  Check the box marked "YES" and type the number and title of this 
program announcement and indicate R01.

2.  Page 2 - Description

As part of the description, identify concisely the fundamental research 
and/or technology or tool to be developed, its innovative nature, its 
relationship to presently available capabilities, and its expected impact on 
biomedical information science and technology and biomedical research.

3.  Research Plan

Item a: Specific Aims

This section should answer the question, "what specifically will be done 
during the proposed funding period?"  The applicant must present specific 
aims that he/she considers to be scientifically appropriate for the relevant 
phases of the project.

For applications that are submitted in response to this PA, research that 
develops new fundamental understanding, technologies, or tools is likely to 
require the application of principles of fields such as computer science, 
mathematics, and engineering.  Clear statements of these underlying 
principles within this section are essential.

Item b: Background and Significance

This section should answer the question, "why is the proposed research 
important?"  Elaborate on the innovative nature of the proposed research. 
Clarify how the fundamental research or tools or technologies to be developed 
as proposed in this project will result in a significant improvement over 
existing approaches.  Explain the potential of the proposed technology for 
having a broad impact on a compelling area of biomedical research.  Clearly 
identify how the project, if successful, would result in new capabilities for 
research, the immediacy of the opportunity and how any proposed technologies 
or tools would differ from existing technologies or tools.

Item c: Preliminary Studies/Progress Report

This section should answer the question, "what have you done to demonstrate 
the feasibility of the proposed research?"

Item d: Research Design and Methods

This section should answer the question, "how will the specific aims be 
accomplished?"  Follow the instructions in the PHS 398 booklet.  For this 
particular program, the applicant should also address plans to make the 
products, tools, or technologies forthcoming from this research available to 
the relevant biomedical research user community.

FOR ALL APPLICATIONS

Appendix:  All instructions in the Form 398 application kit apply.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS:  Applications 
requesting up to $250,000 per year in direct costs must be submitted in a 
modular grant format.  The modular grant format simplifies the preparation of 
the budget in these applications by limiting the level of budgetary detail.  
Applicants request direct costs in $25,000 modules.  Section C of the 
research grant application instructions for the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular grants.  Additional information on modular 
grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.  For R21/R33 
applications that request more than $250,000 in any year in the R33 phase, a 
modular budget for the R21 phase and a detailed budget for the R33 phase 
should be submitted.

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: 
Applications requesting $500,000 or more in direct costs for any year must 
include a cover letter identifying the NIH staff member within one of NIH 
institutes or centers who has agreed to accept assignment of the application.  
More specifically, applicants requesting more than $500,000 must carry out 
the following steps:

1)  Contact the IC program staff at least 6 weeks before submitting the 
application, i.e., as you are developing plans for the study; 

2)  Obtain agreement from the IC staff that the IC will accept your 
application for consideration for award; and,

3)  Identify, in a cover letter sent with the application, the staff member 
and IC who agreed to accept assignment of the application.  

This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended or revised 
version of these grant application types.  Additional information on this 
policy is available in the NIH Guide for Grants and Contracts, October 19, 
2001 at http://grants.nih.gov/grants/guide/notice-files/
NOT-OD-02-004.html. 

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:  The application must be received by the date listed 
on the first page.  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 
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.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review group 
convened in accordance with the standard NIH peer review procedures 
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific 
and technical merit.  

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

o Receive a written critique
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 score
o Receive a second level review by the appropriate national advisory council 
or board

REVIEW CRITERIA 

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  The 
reviewers will comment on the following aspects of the application in their 
written critiques 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

Each of these criteria will be addressed and considered by the reviewers in 
assigning the overall score weighting them as appropriate for each 
application.  Note that the application does not need to be strong in all 
categories to be judged likely to have a major scientific impact and thus 
deserve a high priority score.  For example, an investigator may propose to 
carry out important work that by its nature is not innovative but is 
essential to move a technology forward.

1.  SIGNIFICANCE  
o  Does this study address an important problem?
o  Are the results of the study likely to enable a compelling area of 
biomedical research? 
o  If the aims of the application are achieved, how will scientific knowledge 
be advanced?  
o  What will be the effect of these studies on the concepts or methods that 
drive this field?  
o  To what degree does the research or development of technologies or tools 
support the needs of the targeted biomedical research community?  
o  For systems intended for clinical research or use the additional criteria 
will be considered: 
? to what degree is the approach, technology or tool appropriate for clinical 
research and likely to have utility in a clinical setting? 
? do applicants adequately address such issues as the protection of patient 
information and confidentiality? 

2.  APPROACH  
o  Are the conceptual framework, design, methods, and analyses adequately 
developed, well-integrated, and appropriate to the aims of the project?  
o  Does the applicant acknowledge potential problem areas and consider 
alternative tactics? 
o  What is the time frame for developing the proposed approaches, tools, or 
technologies and is it suitable of this time frame for meeting the needs of 
the relevant biomedical research community's needs?  
o  How easy will it be to use the proposed approach, tool, or technology? 
o  Are the plans for dissemination of the proposed endpoints, tools or 
technologies of the project adequate?

3.  INNOVATION  
o  Does the project employ novel concepts, approaches or method?
o  Are the aims original and innovative? 
o  Does the project challenge existing paradigms or develop new methodologies 
or technologies? 
o  Does the project adequately address end user needs? 
o  Will there be additional application opportunities for the approach, 
technology or tool proposed? 
o  Does the project use high-end computing?

4. INVESTIGATOR  
o  Is the investigator appropriately trained and well suited to carry out 
this work?  
o  Does the project team have adequate expertise in both the areas of 
biomedical information science and technology and biomedical research?
o  Is the work proposed appropriate to the experience level of the principal 
investigator and other researchers (if any)?

5. ENVIRONMENT  
o  Does the scientific environment in which the work will be done contribute 
to the probability of success? 
o  Do the proposed experiments take advantage of unique features of the 
scientific environment or employ useful collaborative arrangements? 
o  Is there evidence of institutional support?
  
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

MILESTONES:  For the R21/R33 Phased Innovation Award Application, the initial 
review group will evaluate the specific goals for each phase and the 
feasibility of milestones that would justify expansion to the R33 phase. A 
single priority score will be assigned to each scored application.  As with 
any grant application, the initial review group has the option of 
recommending support for a shorter duration than that requested by the 
applicant, and basing the final merit rating on the recommended portion of 
the application.

PROTECTIONS:  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.

INCLUSION:  The adequacy of plans to include subjects from both genders, all 
racial and ethnic groups (and subgroups), and children as appropriate for the 
scientific goals of the research.  Plans for the recruitment and retention of 
subjects will also be evaluated.  (See Inclusion Criteria included in the 
section on Federal Citations, below.)

DATA AND SOFTWARE SHARING:  The adequacy of the proposed plan to share data 
and distribute software. 

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

AWARD CRITERIA

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

REQUIRED FEDERAL CITATIONS 

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of the 
research. This policy results from the NIH Revitalization Act of 1993 (Section 
492B of Public Law 103-43).

All investigators proposing clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-
files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are 
available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable; 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS 
(if applicable):  The NIH maintains a policy that children (i.e., individuals 
under the age of 21) must be included in all human subjects research, 
conducted or supported by the NIH, unless there are scientific and ethical 
reasons not to include them. This policy applies to all initial (Type 1) 
applications submitted for receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm. 

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on 
hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).   
It is the responsibility of the applicant to provide the official NIH 
identifier(s)for the hESC line(s)to be used in the proposed research.  
Applications that do not provide this information will be returned without 
review. 

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application. In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The 
Department of Health and Human Services (DHHS) issued final modification to 
the "Standards for Privacy of Individually Identifiable Health Information", 
the "Privacy Rule," on August 14, 2002.  The Privacy Rule is a federal 
regulation under the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 that governs the protection of individually identifiable 
health information, and is administered and enforced by the DHHS Office for 
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified 
under the Rule as "covered entities") must do so by April 14, 2003  (with the 
exception of small health plans which have an extra year to comply).  

Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including 
a complete Regulation Text and a set of decision tools on "Am I a covered 
entity?"  Information on the impact of the HIPAA Privacy Rule on NIH 
processes involving the review, funding, and progress monitoring of grants, 
cooperative agreements, and research contracts can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals 
for NIH funding must be self-contained within specified page limitations. 
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) 
should not be used to provide information necessary to the review because 
reviewers are under no obligation to view the Internet sites.   Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

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 
http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance No. 93.394, Cancer Detection and Diagnosis 
Research.  Awards are made under authorization of the Sections 301 and 405 of 
the Public Health Service Act as amended (42 USC 241 and 284) and 
administered under PHS grants policies and Federal Regulations 42 CFR 52 and 
45 CFR Part 74 and part 92.  This program 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 
http://grants.nih.gov/grants/policy/policy.htm 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)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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