Release Date:  July 12, 2001

RFA:  RFA-HL-01-016

National Heart, Lung, and Blood Institute

Letter of Intent Receipt Dates:  One month prior to application receipt
Application Receipt Dates:  Applications will be accepted every four (4) months 
during fiscal year 2002 on the following receipt dates:  October 18, 2001; 
February 15, 2002; June 18, 2002.

AVAILABLE AT https://grants.nih.gov/grants/funding/phs398/phs398.pdf.  THE 


The purpose of this Request for Applications is to provide limited support, 
not to exceed $100,000 in direct costs per year for up to two years, for 
innovative research activities to test imaginative ideas and explore new 
approaches to heart, lung, and blood diseases and sleep disorders that utilize 
existing data sets or existing biological specimen collections whether 
obtained through NHLBI support or not.  Meritorious studies will be supported 
that are designed to provide preliminary results to demonstrate feasibility of 
novel approaches.  These grant applications should focus on new research that 
is particularly innovative, potentially of high impact and require the use of 
existing data sets or existing biological specimen collections.  Studies are 
limited only to those involving human subjects; however, funds may be used to 
supplement existing data sets and specimen collections to the extent feasible 
within the time and dollar limits of the RFA.  The establishment of new 
collaborations is strongly encouraged.  To simplify the application submission 
process, a shortened research plan format will be used as described in the 
"Special Instructions for Completion" section.  To facilitate the timely 
conduct of the studies approved for support, the Institute will use procedures 
that enable successful applicants to receive funds, to the extent possible, in 
approximately four to six months following application receipt.


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 Request for Applications (RFA), the 
NHLBI Innovative Research Grant Program, 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/.


Applications may be submitted by domestic and foreign, for-profit and 
non-profit organizations, public and private, such as universities, colleges, 
hospitals, laboratories, units of State and local governments, and eligible 
agencies of the Federal government.  Racial/ethnic minority individuals, 
women, and persons with disabilities are encouraged to apply as Principal 


This RFA will use the National Institutes of Health (NIH) research grant (R01) 
award mechanism.  Responsibility for the planning, direction, and execution of 
the proposed project will be solely that of the applicant.  The total project 
period for an application submitted in response to this RFA may not exceed two 
years.  The goal is to have highly meritorious applications that are selected 
for funding under this RFA receive their awards insofar as possible 
approximately four months to six months after the application receipt date.  
The ability to achieve this goal will be significantly influenced by the 
number of applications received for a given submission date, the applicant's 
submission of a complete application, and the ability of a recipient's 
institution to respond quickly with the necessary JUST-IN-TIME information 
when it is requested by NHLBI staff.

Specific application instructions have been modified to reflect "MODULAR 
GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the 
NIH. Complete and detailed instructions and information on Modular Grant 
applications have been incorporated into the PHS 398 (rev. 5/2001).  
Additional information on Modular Grants can be found at 


The NHLBI intends to commit $3 million total costs in FY2002, and an 
additional $1.5 million in total costs in FY2003, to award up to 10 new grants 
following each of the three application receipt dates (October 18, 2001; 
February 15, 2002; June 18, 2002).  An applicant may request a project period 
of up to two years and a budget for direct costs of up to $100,000 (4 modules) 
per year, including facilities and administrative (F&A) costs on consortium 
arrangements.  Although the financial plans of the National Heart, Lung, and 
Blood Institute provide support for this program, awards pursuant to this RFA 
are contingent upon the availability of funds in each fiscal year, and receipt 
of a sufficient number of meritorious applications.



The NHLBI supports laboratory and clinical research to provide better 
understanding of the development and progression of cardiovascular, 
respiratory, blood, and sleep disorders through a variety of research support 
mechanisms.  The goal of this NHLBI program is to facilitate performance of 
short term projects that explore innovative approaches that are not readily 
supported by other funding mechanisms and that require the use of existing 
data sets or existing biological specimen collections.  The program is 
intended to allow exciting new ideas to be investigated in an expeditious 
fashion by relaxing the stringent need for preliminary data and demonstration 
of concept feasibility required by standard NIH research project (R01) 
reviews.  The NHLBI Innovative Research Grant Program encourages both new and 
experienced investigators to explore new collaborations and approaches that 
address promising, yet underdeveloped, research topics and therapeutic 
approaches while employing existing data sets or existing biological specimen 

Considerable time often is required before promising, innovative grant 
applications are developed, reviewed, and funded.  In part, this limitation is 
because the time from submission to award of NIH investigator-initiated 
research proposals is traditionally greater than 9-10 months and frequently 
requires one, or more, revisions for investigators to obtain compelling enough 
preliminary data to merit support.  This program attempts to overcome this 
difficulty by providing a simplified, one-time only submission with a review 
procedure which, to the extent possible, is aimed at enabling successful 
applicants to receive funds in approximately four to six months following 
application receipt.  This will depend on the number of applications received 
on each receipt date, the receipt of complete applications, and the submission 
from applicant institutions of all required information [e.g., for studies 
involving human subjects 
(http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm), IRB approval 
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-031.html) and 
documentation of education in the protection of human subjects 
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html)] in a 
timely manner prior to award.

Research Scope

The NHLBI Innovative Research Grant Program focuses on support of research 
activities that are not easily, or currently, supported by other NIH funding 
mechanisms and that require use of existing data sets or existing biological 
specimen collections.  Activities that promote the formation of new research 
collaborations and explore new approaches and test imaginative new ideas while 
providing preliminary data to demonstrate concept feasibility are especially 

For the purposes of this RFA, grant applications will be allowed in either of 
the two areas defined below as they relate to heart, lung, blood, and sleep 

o  Studies to analyze existing data sets to explore new hypotheses.

o  Studies employing existing biological specimens to test new hypotheses.  As 
one example, investigators could propose collaborative feasibility studies 
between NHLBI-funded epidemiologic studies and investigators expert in genetic 
approaches to examine hypotheses significantly different from those of the 
original study.  The NHLBI Stored Genetics Sample Inventory Database 
(http://webapp.nhlbi.nih.gov/Genetics/) should help identify possible areas of 
new collaborative investigations.  The NHLBI Population Studies Database 
(http://apps.nhlbi.nih.gov/popstudies/) may also be useful in identifying 
sources of existing data sets or existing biological specimen collections.


As stated, applications will be accepted only in the two areas defined above. 
 For example, applications to develop technology or for tissuegenesis would 
not be responsive.  To simplify the request process applications will be 
limited to 10 pages (as described in the "Special Instructions for Completion" 
section).  An applicant may not submit more than one application per receipt 
date, and a Principal Investigator can not have more than one concurrent grant 
award under the aegis of this RFA.  Replacement of the Principal Investigator 
on this award is not permitted.  Revisions of applications previously reviewed 
under this initiative but unfunded are not permitted.  A new application must 
be substantially different from one previously reviewed and have a different 
title in order to be accepted for review.  The application must focus on one 
of the topics in the announcement when the new application is submitted.  All 
applications will be reviewed as new applications. 

Establishment of new collaborations is an important goal of this program.  A 
letter indicating that the investigators from the original study intend to 
cooperate and are willing to share samples and data, and have approved the 
proposed study must be included with the application.


It is the policy of the NIH that women and members of minority groups and 
their subpopulations must be included in all NIH supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification is provided 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 research involving human subjects should read the 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a 
complete copy of the updated Guidelines are available at 
https://grants.nih.gov/grants/funding/women_min/guidelines_update.htm.  The 
revisions relate to NIH defined Phase III clinical trials and require: a) all 
applications or proposals and/or protocols to 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) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.


It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted or supported by the 
NIH, unless there are clear and compelling 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 was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL: 


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.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site. 


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


Prospective applicants are asked to submit one month prior to the application 
receipt dates 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 this RFA.  Although the letter of 
intent is not required, is not binding, does not commit the sender to submit 
an application, and does not enter into the review of subsequent applications, 
the information that it contains allows review to estimate the potential 
review workload and to plan the review.  IT IS HIGHLY RECOMMENDED THAT THE 
LETTER OF INTENT BE SUBMITTED, and it should be sent to Dr. Beebe at the 
address listed under INQUIRIES.


Applicants are strongly encouraged to call program staff listed in INQUIRES 
below with any questions regarding the responsiveness of their proposed 
project to the goals of this RFA. 

The modular grant concept establishes specific modules in which direct costs 
may be requested as well as a maximum level for requested budgets. Only 
limited budgetary information is required under this approach.  The 
just-in-time concept allows applicants to submit certain information only when 
there is a possibility for an award. It is anticipated that these changes will 
reduce the administrative burden for the applicants, reviewers and NIH staff. 
The research grant application form PHS 398 (rev. 5/2001) at 
https://grants.nih.gov/grants/funding/phs398/phs398.pdf is to be used in 
applying for these grants, with the modifications noted below.  Applicants are 
permitted, however, to use the 4/1998 revision of the PHS 398 for scheduled 
application receipt dates until January 9, 2002.  If you are preparing an 
application using the 4/1998 version, please refer to the step-by-step 
instructions for Modular Grants available at 


The research plan in the application should be limited to 10 pages, excluding 
references.  The research plan includes specific aims, background and 
significance, preliminary studies, and research design and methods (Sections A 
to D).  Following the submission of the application and appendix material, no 
additional supplementary material is to be submitted.

To facilitate the accelerated award schedule, applicants will be notified of 
the need to submit JUST-IN-TIME information when there is the potential for an 

Amended applications will NOT be accepted.

Applicants from institutions that have a General Clinical Research Center 
(GCRC) funded by the NIH National Center for Research Resources may wish to 
identify the GCRC as a resource for conducting the proposed research.  If so, 
a letter of agreement from either the GCRC Program Director or Principal 
Investigator should be included with the application. 


The modular grant concept establishes specific modules in which direct costs 
may be requested as well as a maximum level for requested budgets.  Only 
limited budgetary information is required under this approach.  The 
just-in-time concept allows applicants to submit certain information only when 
there is a possibility for an award.  It is anticipated that these changes 
will reduce the administrative burden for the applicants, reviewers and 
Institute staff.  The research grant application form PHS 398 (rev. 5/01) at 
https://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in 
applying for these grants, with the modifications noted below.


Modular Grant applications will request direct costs in $25,000 modules, up to 
a total direct cost request of $250,000 per year. (Applications that request 
more than $250,000 direct costs in any year must follow the traditional PHS 
398 application instructions.)  The total direct costs must be requested in 
accordance with the program guidelines and the modifications made to the 
standard PHS 398 application instructions described below:

PHS 398

o  FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in 
$25,000 increments up to a maximum of $100,000) and Total Costs [Modular Total 
Direct plus F&A costs] for the initial budget period.  Items 8a and 8b should 
be completed indicating the Direct and Total Costs for the entire proposed 
period of support.

of the PHS 398.  It is not required and will not be accepted with the 

categorical budget table on Form Page 5 of the PHS 398.  It is not required 
and will not be accepted with the application.

o  NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative 
page.  (See https://grants.nih.gov/grants/funding/modular/modular.htm for 
sample pages.) At the top of the page, enter the total direct costs requested 
for each year.  This is not a Form page.

o  Under Personnel, list key project personnel, including their names, percent 
of effort, and roles on the project.  No individual salary information should 
be provided.  However, the applicant should use the NIH appropriation language 
salary cap and the NIH policy for graduate student compensation in developing 
the budget request.

For Consortium/Contractual costs, provide an estimate of total costs (direct 
plus F&A costs) for each year, each rounded to the nearest $1,000.  List the 
individuals/organizations with whom consortium or contractual arrangements 
have been made, the percent effort of all personnel, and the role on the 
project.  Indicate whether the collaborating institution is foreign or 
domestic.  The total cost for a consortium/contractual arrangement is included 
in the overall requested modular direct cost amount.  Include the letter of 
intent to establish a consortium.

o  BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by 
reviewers in the assessment of each individual's qualifications for a specific 
role in the proposed project, as well as to evaluate the overall 
qualifications of the research team.  A biographical sketch is required for 
all key personnel, following the instructions below.  No more than three pages 
may be used for each person.  A sample biographical sketch may be viewed at: 

-  Complete the educational block at the top of the form page;
-  List position(s) and any honors;
-  Provide information, including overall goals and responsibilities, on 
research projects
   ongoing or completed during the last three years.
-  List selected peer-reviewed publications, with full citations;

o  CHECKLIST - This page should be completed and submitted with the 
application.  If the F&A rate agreement has been established, indicate the 
type of agreement and the date.  All appropriate exclusions must be applied in 
the calculation of the F&A costs for the initial budget period and all future 
budget years.

o  The applicant should provide the name and phone number of the individual to 
contact concerning fiscal and administrative issues if additional information 
is necessary following the initial review. 

The RFA label available in the PHS 398 (rev. 4/98) 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 

The sample RFA label available at: 
https://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to 
allow for this change.  Please note this is in pdf format.

Please note that color figures or photos present in the body of the grant 
application should also be present in the appendix, or high-quality 
reproductions of the pages containing color or half-tone figures should be 
included in the appendix.  The reviewers will receive a black-and-white copy 
of the grant application together with the appendix.

Submit a signed, typewritten original of the application, including the 
Checklist, and three signed, photocopies, in one package to:

BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

At the time of submission, two additional copies of the application as well as 
all five collated sets of Appendix material must be sent to Dr. Deborah Beebe 
at the address listed under Inquiries.

Applications must be received by the application receipt date listed in the 
heading of this RFA.   The receipt dates are October 18, 2001; February 15, 
2002; and June 18, 2002.  If an application is received after the receipt 
date, it will be returned to the applicant without review.
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.  The 
CSR will not accept any application that is essentially the same as one 
already reviewed.

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NHLBI.  Incomplete and/or non-responsive applications 
will be returned to the applicant without further consideration.

Applications that are complete and responsive to the RFA will be evaluated for 
scientific and technical merit by a review process convened by the NHLBI in 
accordance with the review criteria stated below.  As part of the initial 
merit review, all applications will receive a written critique and undergo a 
process in which only those applications deemed to have the highest scientific 
merit, generally the top half of the applications under review, will be 
discussed, assigned a priority score, and receive a second level review by the 
National Heart, Lung, and Blood Advisory Council.

Review Criteria

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
their written comments reviewers will be asked to discuss the following 
aspects of the application in order to judge the likelihood that the proposed 
research will have a substantial impact on the pursuit of these goals.  Each 
of these criteria will be addressed and considered in assigning the overall 
score.  Because of the nature of this RFA, and application must be judged to 
be innovative to deserve a high priority score.

(1) Significance: Does this study address an important problem? If the aims of 
the application are achieved, how will scientific knowledge be advanced? What 
will be the effect of these studies on the concepts or methods that drive this 

(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 method? 
Are the aims original and innovative? Does the project challenge existing 
paradigms or develop new methodologies or technologies?

(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 the work will be 
done contribute to the probability of success? Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements? Is there evidence of institutional support?

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

o The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research.  If the proposed research includes studies in human subjects, plans 
for the recruitment and retention of subjects will also be evaluated.

o The reasonableness of the proposed budget and duration in relation to the 
proposed research

o 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.


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

o  scientific merit (as determined by peer review)
o  availability of funds
o  program priorities.


Inquiries concerning this RFA are encouraged.  The opportunity to clarify any 
issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

David A. Lathrop, Ph.D.
Division of Heart And Vascular Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 9186 (MSC 7940)
Bethesda, MD 20892-7940 (20817 for Courier)
Telephone:  (301) 435-0504
FAX:  (301) 480-1454
Email:  LathropD@nhlbi.nih.gov

Darrell L. Ellsworth, Ph.D.
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 8166 (MSC 7934)
Bethesda, MD 20892-7934 (20817 for Courier)
Telephone:  (301) 435-0444
FAX:  (301) 480-1455
Email:  EllsworD@nhlbi.nih.gov

John W. Thomas, Ph.D.
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 10154 (MSC 7950)
Bethesda, MD 20892-7950 (20817 for Courier)
Telephone:  (301) 435-0050
FAX:  (301) 451-5453
Email: ThomasJ@nhlbi.nih.gov 

Carol E. Vreim, Ph.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 10120 (MSC 7952)
Bethesda, MD 20892-7952 (20817 for Courier)
Telephone:  (301) 435-0233
FAX:  (301) 480-3547
Email: VreimC@nhlbi.nih.gov

Send letter of intent and 2 copies of application and direct inquiries 
regarding review matters to:

Deborah P. Beebe, Ph.D.
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Dr., Room 7178 (MSC 7924)
Bethesda, MD 20892-7924 (20817 for Courier)
Telephone:  (301) 435-0270
Fax:  (301) 480-3541
Email:  BeebeD@nhlbi.nih.gov

Direct inquiries regarding fiscal matters to:

Robert Vinson
Grants Operations Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7156, MSC 7926
Bethesda, Maryland  20892-7926
Telephone: (301) 435-0171
FAX:  (301) 480-3310
E-mail:  VinsonR@nhlbi.nih.gov 


This program is described in the Catalog of Federal Domestic Assistance No. 
93.837, 93.838, 93.839.  Awards are made under authorization of the Public 
Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public 
Law 99-158, 42 USC 241 and 285) and administered under NIH grants policies and 
Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  This program is not 
subject to the intergovernmental review requirements of Executive Order 12372 
or Health Systems Agency review.  

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and promote the non-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.

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