RELEASE DATE:  March 02, 2004
RFA Number:  RFA-HL-04-018
EXPIRATION DATE: September 22, 2004

Department of Health and Human Services (DHHS)
National Institutes of Health (NIH)

National Heart, Lung, and Blood Institute (NHLBI)


APPLICATION RECEIPT DATE: September 21, 2004  


o Purpose of this RFA
o Research Objectives
o Mechanism of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations


The primary objective of the Specialized Centers of Clinically Oriented Research 
(SCCOR) programs is to foster multidisciplinary research on clinically relevant 
questions enabling basic science findings to be more rapidly applied to clinical 
problems. The clinical and basic research supported through this RFA program in 
transfusion biology and medicine is to support the development and application of new 
knowledge essential for improved safety, efficacy, and availability of blood, blood 
components, and plasma derivatives, and to transfer these research findings into 
clinical evaluation and application.  


The National Heart, Lung, and Blood Institute (NHLBI) revised the Specialized Centers 
of Research (SCOR) program, based primarily on recommendations from the National 
Heart, Lung, and Blood Advisory Council. The new program is called the Specialized 
Centers of Clinically Oriented Research (SCCOR) program. The original SCOR program 
required both basic and clinical research, but the preponderance of funded projects 
were in the basic science arena. The new title and the revisions to the program 
reflect the Institute's desire to capitalize on basic research advances by encouraging 
their translation to the clinical arena. The guiding principle of the new SCCOR 
program is the central focus on clinically relevant research, and the key change to 
achieve this goal is the requirement that at least one-half of funded projects be 
clinical. The specific components of the new SCCOR program are detailed in this RFA. 
Special instructions for preparing a SCCOR application are available from the program 
contact listed under WHERE TO SEND INQUIRIES or at 

Opportunities for research in transfusion medicine are increasing and have expanded to 
include any blood component or bone marrow derived cell. There continues to be a 
substantial need for performing evidence-based studies to evaluate the best approaches 
to provide blood and bone marrow derived components to patients. Listed below are four 
general areas of emphasis and specific examples are outlined for which studies would 
be considered to be responsive to this RFA announcement.  The different research 
topics and approaches described below in the four areas of emphasis provide potential 
applicants with examples of topics that interest the NHLBI. These examples, however, 
are not meant to be all inclusive. Investigators are encouraged to consider pursuing 
other important and innovative research topics as well. It should be emphasized, 
however, that the topics chosen must relate directly to the four areas of emphasis 
identified in this initiative. Furthermore, topics may address more than one area of 
emphasis. For example, it would be appropriate for an application to propose projects 
that address research issues pertaining to one area of interest such as immunologic 
responses to blood components or platelet storage or a combination such as immunologic 
responses to blood components and platelet substitutes. It should be noted, however, 
that SCCOR investigations which focus exclusively on cellular therapy will not be 
considered responsive to this RFA.


Maintaining an adequate supply of blood components to meet patient needs for 
transfusion involves many factors including a broad donor base, methods of storing 
blood components, and determining appropriate indications for their use to avoid 
unnecessary and/or ineffective transfusions. Areas for research questions include:

o   Determine the benefits of iron supplementation to donors;
o   Evaluate donor safety issues such as: frequency of donations, quantity of blood 
components removed, and effects of cytokines given to donors to enhance the 
collection of blood components;
o   Recruitment and retention of donors.

o   Storage and Utilization of Blood Components
o   Determine optimal transfusion triggers for cellular and plasma blood components 
to reduce ineffective use;
o   Assess the appropriate transfusion dose for each blood component;
o   Evaluate methods of extending the storage time for cellular components, 
particularly platelets;
o   Determine how to judge the safety and efficacy of blood component therapy.


Substantial progress has been made over the last several years in the identification 
of and testing for viruses that are capable of being transmitted by transfusion.  The 
following areas of blood transfusion safety have received little emphasis and now 
represent the biggest transfusion risks for patients:

Safety of blood products

o   Develop methods of blood product and recipient identification to ensure the 
correct product is given to the designated recipient;
o   Identify processes to either detect bacterial contamination or inhibit the 
growth of bacteria in transfused blood products B particularly platelets;
o   Identify ligands and/or receptors on erythrocytes for microbe binding.

Blood Group Incompatibility

o   Develop improved methods of antigen typing to insure a compatible transfusion;
o   Identify systems to reduce alloimmunization in transfusion dependent patients;  
o   Determine the pathophysiological events in Hemolytic Disease of the Newborn and 
identify preventative clinical intervention.

There are both desirable and undesirable immunologic consequences of the transfusion 
of blood components or marrow derived cells. For all of these transfusion related 
effects, additional studies are needed to understand the factors associated with their 
development. These factors include the influence of the type, amount, and timing of 
transfusions on their occurrence, ways that desirable effects can be enhanced while 
undesirable effects are eliminated, and the pathophysiologic events associated with 
these conditions. Topics include:

Desirable Effects

o   Graft vs. Leukemia;
o   Induction of tolerance to organ grafts.

 Undesirable Effects

o   Alloimmunization and refractoriness to platelet transfusions;
o   Alloimmunization to red cells with reduction in the available compatible donor 
o   Transfusion associated acute lung injury (TRALI);
o   Immunomodulatory effects of transfusion such as infection and tumor 
o   GVHD


Transfusion medicine has traditionally been involved in the production and storage of 
red cells, platelets, granulocytes, and plasma components. Another topic of interest 
has been the evaluation of their use in transfusions. However, it has become clear 
that there are many other types of blood and bone marrow derived cells that have 
important biologic functions. Therefore, of substantial interest are studies on the 
characterization of these cell types by exploring their role in the pathophysiology of 
human diseases, and methods for the manipulation and transfusion of these cells to 
provide a therapeutic benefit to patients. Examples of these therapies are listed 

Mononuclear Cell Fractions

o   Identify and characterize the stem cells that are associated with rapid and long 
term engraftment;
o   Develop methods for proliferation of stem cells in vitro;
o   Characterize the cells associated with GVHD and determine how this adverse 
effect can be eliminated/modified;
o   Identify factors associated with the development of peripheral blood stem cells 
as well as other blood cells.

Pluripotent Stem Cells

o   How can the use of marrow derived cells in organogenesis be potentiated;
o   What factors are associated with the development of "plasticity" and how can this 
be facilitated;
o   What governs the trafficking of cells to desired locations.

Cellular Engineering of New Blood Components

o   Develop blood "substitutes" which can take the place of "classic" blood component 

Modification of Leukocytes to Act as Vaccines for the Treatment of Malignancies or 
Infectious Diseases

o   What are the best cells to use for targeted vaccine therapy;
o   What are the best ways to develop "vaccinated cells";
o   How should they be used, and how is their effectiveness determined.

Gene Therapy

o   Use cells to "cure" genetic diseases by inserting into cells the genetic material 
of interest; 
o   Identify the most appropriate cells to use as the hosts for genetic material;
o   Determine how should the genetic material be inserted;
o   Determine how should genetically modified cells be infused (locally or 
systemically), the frequency of administration;
o   Establish ways to monitor the effectiveness of this therapy.

Treatment of Autoimmune Diseases by Cellular Therapy

 Adoptive Immunotherapy

o   Peripheral blood mononuclear cells can be manipulated ex vivo and transfused to 
decrease or enhance immune function.

Clinical Research Skills Development Core

The newly developed Specialized Centers of Clinically Oriented Research (SCCOR) 
program mechanism requires clinical and basic scientists with a broad range of skills 
to work together on a unified theme. It, therefore, presents a rich environment for 
young clinical investigators to be exposed to and develop additional research skills. 
The individual centers can be expected to include among their research staffs clinical 
personnel who are newly trained and relatively inexperienced in research. To assist 
the SCCOR grants in enhancing the developmental environment for their new clinical 
investigators, the NHLBI will permit applicants for a new SCCOR to request up to 
$100,000 in direct costs per year for a Clinical Research Skills Development Core. The 
objective of the Core is to support activities to assist new clinical investigators in 
progressing to more senior status by enhancing their research skills. This support is 
in addition to the usual cap on the SCCOR mechanism that is updated annually. A 
Clinical Research Skills Development Core is not required, however, and its absence 
will not disadvantage an applicant. The quality of the Clinical Research Skills 
Development Core, if proposed, will be evaluated based on the specific components 
listed below. The priority score on the Core will have no effect on the overall score 
of an application. 

Developmental opportunities that provide experience with new technologies and skills 
are encouraged for inclusion in the Core. Innovative strategies should be proposed for 
cross-disciplinary career development to achieve the goal of exposing new clinical 
investigators to additional research techniques and opportunities. Examples include a 
program of seminars focusing on scientific topics that include an integration of basic 
and clinical studies or an "exchange" program wherein clinical investigators spend 
time in basic science laboratories. In addition to developing the research skills of 
new clinical investigators, the Cores must ensure that the participating new clinical 
investigators receive the mentoring they need to foster their research careers. The 
Clinical Research Skills Development Core is intended for staff investigators with 
limited clinical research experience, including fellows and junior faculty members. 
Investigators who have had a previous K series award are not eligible to participate 
as new investigators under this program.  Individuals with an active K grant can 
participate until the end of the award period for the K grant, but may not receive 
salary on the Skills Development Core. The Core should also address other skills 
necessary for a successful research career, such as grant writing, ethical conduct of 
research, and clinical trial design. 

If a Clinical Research Skills Development Core is proposed, it must be directed by an 
investigator with strong educational and mentoring credentials who will devote a 
minimum of 5 percent effort as its Leader. To facilitate mentoring and 
multidisciplinary developmental activities, active involvement by the principal 
investigator and other senior investigators within the SCCOR is strongly encouraged. 
An application for a Clinical Research Skills Development Core will be evaluated in 
terms of its potential effectiveness in developing the skills and research 
capabilities of new clinical investigators as reflected in the following required 
elements of the application: 

o   A summary of the types of skills that would be developed and a description of 
proposed project-specific activities; 

o   A detailed discussion of how mentoring and the professional development of the 
new clinical investigators will be achieved, including their progression to more 
independent status;  

o   The credentials and track records of the Clinical Research Skills Development 
Core Leader, the Principal Investigator, and other participating senior staff in 
developing new investigators;  

o   A plan for coordinating the activities of participating senior investigators;  

o   A plan for monitoring the progress of the new clinical investigators;  

o   A description of existing opportunities within the applicant's institution for 
supporting investigator development and steps taken to avoid overlap with or 
duplication of these efforts; 

o   A detailed development plan for each proposed new investigator (or a 
representative plan and proposals for tailoring it to needs of multiple new 
investigators) including required course work and scientific enrichment 
activities such as special lectures, visiting scientist symposia, seminars, and 

Costs allowable for inclusion within the $100,000 direct costs per year limit for the 
Clinical Research Skills Development Core include salary support for the Core Leader 
and other participating senior investigators and staff, travel costs for new 
investigators, supplies and equipment to be used in support of developmental 
activities, and costs for courses, seminars, workshops, and other activities directly 
related to the development plan. All costs requested in this Core must be justified 
with respect to developmental activities and may not be used to supplement the costs 
of research proposed in the rest of the SCCOR.

Since the Core is intended to serve new clinical investigators who occupy positions 
and receive salary support from the SCCOR grant, salary support for the new 
investigators is neither needed nor allowable as a Core cost. All new clinical 
investigators supported by the SCCOR grant should be eligible to participate in Core-
sponsored activities so long as they have not attained independent status. However, 
attaining independent status should be an objective of the Core activities so 
participating new investigators should be encouraged to apply for either a Career 
Development Award, a patient-oriented regular research grant, or any other source of 
independent research or career development support. Although the participating new 
investigators will be expected to devote essentially full-time effort to research 
during this period, they may devote an appropriate percentage of their time to 
maintaining clinical skills.

An application for a Clinical Research Skills Development Core will be evaluated in 
terms of its potential effectiveness in developing the skills and research 
capabilities of new clinical investigators as reflected in the required application 
components identified above.

This RFA will use the NIH P50 award mechanism. All applications received in response 
to the Transufsion Biology and Medicine Diseases SCCOR program will be considered as 
new applications and must meet the requirements for the new SCCOR program. As an 
applicant you will be solely responsible for planning, directing, and executing the 
proposed project. The anticipated award date is February 1, 2006.

Each NHLBI SCCOR program is limited to 10 years of support. Exceptions to this policy 
will be made only if a thorough evaluation of needs and opportunities, conducted by a 
committee composed of non-federal experts, determines that there are extraordinarily 
important reasons to continue a specific SCCOR program. Under this policy, a given 
SCCOR grant is awarded for a 5-year project period following an open competition. Only 
one 5-year competing renewal is permitted, for a total of 10 years of support, unless 
the SCCOR program is recommended for extension.

The NHLBI comprehensive evaluation of the Transfusion Biology and Medicine SCCOR 
program will be conducted during the second project period according to the following 

Program Announced:                    FY 2004

Project Period (First Competition):   FY 2006 through FY 2011

Program Reannounced:                  FY 2009

Project Period (Second Competition):  FY 2011 through FY 2016

Letter to Principal Investigators 
Regarding SCCOR Evaluation Plans:     FY 2012 (mid-way through year 02
                                               of 2nd project period)

SCCOR Evaluation Meeting:             FY 2013 (late in year 02 of 2nd
                                               project period) 

The NHLBI does not limit the number of applications for a given SCCOR program from one 
institution. However, each SCCOR application from the institution must have a 
different principal investigator and must be self-contained and independent of other 
SCCOR applications from the same institution. Institutions envisioning more than one 
application are encouraged to discuss their plans with the program contact listed 
under Where to Send Inquiries.

The NHLBI intends to commit approximately $4.0 million in FY 2006 to fund 2 to 3 new 
grants in response to this RFA. An applicant may request a project period of up to 5 
years and a budget for direct costs up to $2.0 million not including Facilities and 
Administrative (F&A) costs for collaborating institutions, in the first year. In 
addition, applicants for a new SCCOR may request up to $100,000 in direct costs per 
year above the usual cap ($2.0 million direct costs) for a Clinical Research Skills 
Development Core. All applications will be considered as new applications. An increase 
of no more than 3 percent may be requested in each additional year. Because the nature 
and scope of the proposed research will vary from application to application, it is 
anticipated that the size and duration of each award will also vary. Although the 
financial plans of the NHLBI provide support for this program, awards pursuant to this 
RFA are contingent upon the availability of funds and the receipt of a sufficient 
number of meritorious applications.

Consortium Arrangements
If a grant application includes research activities that involve institutions other 
than the grantee institution, the application will be considered a consortium effort. 
Such applications are permitted, but it is imperative that the application be prepared 
so that programmatic, fiscal, and administrative considerations are explained fully. 
At least 50 percent of projects (including at least one clinical project) and 50 
percent of the cores must be located at the applicant institution. The NIH published 
policy governing consortia is available in the business offices of institutions that 
are eligible to receive Federal grants-in-aid and should be consulted before 
developing the application. For clarification of the policy, contact Mr. Anthony 
Agresti, Grants Operation Branch, NHLBI, (301) 435-0171. Applicants for SCCOR grants 
should exercise great care in preserving the interactions of the participants and the 
integration of the consortium project (s) with those of parent institution, because 
synergism and cohesiveness can be diminished when projects are located outside the 
group at the parent institution. Indirect costs paid as part of a consortium agreement 
are excluded from the limit on the amount of direct costs that can be requested.

You may submit (an) application(s) if your institution has any of the following 
o   For-profit or non-profit organizations 
o   Public or private institutions, such as universities, colleges, hospitals, and 
o   Units of State and local governments
o   Eligible agencies of the Federal government 
o   Foreign institutions are not eligible to apply. 

Individuals with the skills, knowledge, and resources necessary to carry out the 
proposed research are 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.  
1. The overall concept of a SCCOR program focuses on clinical and basic scientific 
issues related to diseases and disorders relevant to the mission of the NHLBI. To be 
considered responsive to this announcement, all applications must include both 
clinical and basic research. In addition, interactions between clinical and basic 
scientists are expected to strengthen the research, enhance the translation of 
fundamental research findings to the clinical setting, and identify new research 
directions. Translation of findings from basic to clinical studies is an important 
focus of the SCCOR program. 
2. The number of clinical research projects in each NHLBI SCCOR must be equal to or 
greater than the number of basic science projects, at the time of submission, award, 
and throughout the 5-year project period. For example, if an application has a total 
of three projects, two of the projects must be clinical research projects. Neither a 
clinical component in a basic science project nor a clinical core fulfills the 
requirement for a clinical project. However, a single project can integrate basic and 
clinical research. If the majority of the research within a project is clinical, it 
will be considered a clinical project; if the majority of the research within a 
project is basic, it will be considered a basic project. Because a SCCOR grant is a 5-
year program, an applicant should submit a 5-year plan for all the projects. 

3. In order for a project to be considered clinical research for the purposes of 
responsiveness to this RFA, the research must be patient-oriented research. Patient-
oriented research is research in which an investigator (or colleague) directly 
interacts with patients having a disease or condition of interest. Normal healthy 
subjects may be included, but only in combination with studies involving patients. In 
studies involving the use of human specimens, the investigators must have direct 
interaction with the patient from whom the specimen is obtained and relate the 
research results to the patient status or outcome for this to be considered a clinical 
project. It is intended that the requirement for investigator interaction with the 
study participants will eliminate research involving archived tissue.

Applicants are encouraged to pursue patient-oriented research on topics related to 
health disparities and the translation of this research to clinical practice for 
affected minority populations. At a minimum, clinical research projects must include 
women and minorities in the study population in representative numbers, unless such 
inclusion can be demonstrated to be inappropriate. Clinical studies involving 
interventions or treatments must give consideration to including sufficient numbers of 
women and minorities to conduct valid analyses of subgroup effects. Epidemiologic 
studies or Phase III clinical trials will be considered unresponsive to this RFA.

4. Each awarded SCCOR must consist of three or more projects, all of which are 
directly related to the overall clinical focus of the SCCOR. At least 50 percent of 
the projects and 50 percent of the cores must be located at the applicant institution 
and at least one of the clinical projects must be at the applicant institution. 
Component projects not located at the applicant institution may be at a foreign 
institution, but must conform to NIH policy regarding the protection of human 
subjects. Each component project, whether clinical or basic, requires a well-described 
clinically relevant hypothesis, preliminary data, and a time-table for conducting the 
proposed investigations.

5. The relationship of each core to each component project should be described. A core 
must provide services to two or more projects. 

6. Each SCCOR must have a well-delineated organizational structure and administrative 
mechanism that foster interactions between investigators, accelerate the pace of 
research, enable translation of basic research findings to clinical applications, and 
ensure a productive research effort.

7. Applicants should provide a detailed data and safety monitoring plan for the 
clinical research proposed; the monitoring plan will be considered as part of peer 
review of the application. This plan should address informed consent, recruitment, 
reporting of adverse events, patient safety, oversight of clinical issues in the 
protocols, storage and analysis of confidential data, and dissemination of any 
research results. After a decision has been made regarding SCCOR awards, the Institute 
will determine whether to convene a Data and Safety Monitoring Board to oversee one or 
more clinical projects in a SCCOR program. 

8. The principal investigator should be an established research scientist with the 
ability to ensure quality control and the experience to administer both clinical and 
basic research effectively and integrate all components of the program. A minimum time 
commitment of 25 percent is required for this individual. The principal investigator 
must be the project leader of one of the component research projects. If this project 
is not recommended by peer review, the overall SCCOR application will not be 
considered further. If this project is judged by peer review to be of low scientific 
merit, this will markedly reduce the overall scientific merit ranking assigned to the 
entire application. 

9. Project leaders should have significant research experience and must agree to 
commit at least 20 percent effort to each project for which they are responsible. 
Leaders of clinical projects should have experience in clinical research as defined in 
Item 2, above. Investigators with minimal research experience, but promising 
credentials, may participate; however, it is expected that most of the project leaders 
will be investigators with significant research experience.

10. Applicants are encouraged to establish links and utilize existing resources, 
including the NHLBI Program in Genomic Applications, NHLBI clinical research networks, 
and General Clinical Research Centers, as feasible and appropriate. If applicants 
propose to utilize such resources, a letter of agreement from the program director or 
principal investigator of the resource should be included with the application.


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

o Direct your questions about scientific/research issues to:

Dr. Luiz H. Barbosa
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
Building Two Rockledge Center, Room 10140
Bethesda, MD 20892
Telephone: (301) 435-0075
FAX: (301) 480-1060
Email: BarbosaL@nhlbi.nih.gov

o Direct your questions about peer review issues to:

Dr. Anne P. Clark
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214, MSC 7924
Bethesda, MD 20892-7924
Telephone: (301) 435-0270
Fax:  (301) 480-0730
Email: ac42y@nih.gov 

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

Ms. Shelia L. Ortiz
Division of Extramural Affairs
National Heart, Lung & Blood Institute
6701 Rockledge Drive, Suite 7044
Bethesda, MD 20892-7926
(301)435-0166  FAX (301)480-3310
Prospective applicants are asked to submit a letter of intent that includes the 
following information:

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

Although a letter of intent is not required, is not binding, and does not enter into 
the review of a subsequent application, the information that it contains allows IC 
staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed at the beginning of this 
document. The letter of intent should be sent by mail or email to Dr. Anne Clark at 
the address listed under “Where to Send Inquiries”.


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 http://www.dunandbradstreet.com/. 
The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The 
PHS 398 document is available at 
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format.  For 
further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: 

SUPPLEMENTARY INSTRUCTIONS: Because of the size and complexity of a SCCOR, prospective 
applicants are urged to consult with the staff of the Division of Blood Diseases and 
Resources early in the preparation of the application (see INQUIRIES Section). Special 
instructions are needed for preparing a SCCOR application and are available from the 
program contact listed under WHERE TO SEND INQUIRIES, or at 

Each NHLBI SCCOR program is limited to 10 years of support.  Exceptions to 
this policy will be made only if a thorough evaluation of needs and 
opportunities, conducted by a committee composed of non-federal experts, 
determines that there are extraordinarily important reasons to continue a 
specific SCCOR program.  Under this policy, a given SCCOR grant is awarded for 
a 5-year project period following an open competition.  Only one 5-year 
competing renewal is permitted, for a total of 10 years of support, unless the 
SCCOR program is recommended for 

The NHLBI does not limit the number of applications for a given SCCOR program 
from one institution. However, each SCCOR application from the institution 
must have a different principal investigator and must be self-contained and 
independent of other SCCOR applications from the same institution. 
Institutions envisioning more than one application are encouraged to discuss 
their plans with the program contact listed under Where to Send Inquiries.

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application 
form must be affixed to the bottom of the face page of the application. Type the RFA 
number on the label. Failure to use this label could result in delayed processing of 
the application such that it may not reach the review committee in time for review. In 
addition, the RFA title and number must be typed on line 2 of the face page of the 
application form and the YES box must be marked. The RFA label is also available at: 
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the 
application, including the Checklist, and three signed, photocopies, in one package 
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)
At the time of submission, two additional copies of the application and all copies of 
the appendix material must be sent to:

Anne P. Clark, Ph.D.
Chief, Review Branch
Division of Extramural Affairs 
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214, MSC 7924
Bethesda, MD 20892-7924
Bethesda, MD 20817 (for express/courier service)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: ac42y@nih.gov

Applications must be received on or before the application receipt date listed in the 
heading of this RFA. If an application is received after that 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.  
However, when a previously unfunded application, originally submitted as an 
investigator-initiated application, is to be submitted in response to an RFA, 
it is to be prepared as a NEW application.  That is, the application for the 
RFA must not include an Introduction describing the changes and improvements 
made, and the text must not be marked to indicate the changes from the 
previous unfunded version of the application.  
Principal investigators should not send supplementary material without first 
contacting the Scientific Review Administrator (SRA). The SRA will be identified in 
the letter sent to you indicating that your application has been received. If you have 
not received such a letter within three weeks after submitting the application, 
contact Dr. Anne Clark at the address listed under “Where to Send Inquiries”. 

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 an appropriate peer review group convened by the 
NHLBI in accordance with the review criteria stated below. As part of the initial 
merit review, all applications will:

o Undergo a process in which only those applications deemed to have the highest 
scientific merit, generally the top half of the applications under review, will be 
discussed and assigned a priority score 
o Receive a written critique 
o Receive a second level review by the National Heart, Lung, and Blood Advisory 


The goals of NIH-supported research are to advance our understanding of biological 
systems, improve the control of disease, and enhance health. Factors to be considered 
in the evaluation of each application will be similar to those used in the review of 
traditional clinical and basic research grant applications and, in addition, will 
include overall proposed interactions between clinical and basic research projects. 
The review panel will include a majority of clinical researchers who will receive 
special instructions to place emphasis on strong clinical components. Major factors to 
be considered in the evaluation of applications include: 

o   Scientific merit of the proposed clinical and basic research projects including 
significance, importance, clinical relevance and appropriateness of the theme; 
innovation, originality, and feasibility of the approach; and adequacy of the 
experimental design.

o   Leadership, scientific expertise, experience, and commitment of the principal 
investigator; competence of the investigators to accomplish the proposed 
research goals and their time commitment to the program; clinical research 
experience among the investigators; and the feasibility and strength of 
consortium arrangements.

o   Collaborative interaction between clinical and basic research components and the 
adequacy of plans for transfer of potential findings from basic to clinical 

o   Adequacy of the environment for performance of the proposed research including 
clinical populations and/or specimens; laboratory facilities; quality of the 
support cores; proposed instrumentation; quality controls; administrative 
structure; institutional commitment; and, when needed, data management systems. 

o   Adequacy of the data and safety monitoring plan for the clinical research 

Each project will receive a priority score. Each core (except the Clinical Research 
Skills Development Core) will be Recommended or Not Recommended based on whether the 
core is essential for the proposed research and has the capability to fulfill the 
proposed function. Reviewers will evaluate the number of projects serviced by the 
core; strengths and weaknesses of the proposed approaches, resources, and 
interactions; whether the investigators are qualified for their role(s) in the core; 
and whether the proposed budget for the core is appropriate. Each application will 
receive an overall priority score based on the review criteria listed above.  

The Clinical Research Skills Development Core will receive a priority score based on 
the review criteria below, but the priority score will not enter into the overall 
priority score.  

Review Criteria for Clinical Research Skills Development Core 

The Clinical Research Skills Development Core will be evaluated for its effectiveness 
in developing the skills and clinical research capabilities of new investigators. This 
will include an evaluation of:  

o   Credentials and track record of the Principal Investigator, Clinical Research 
Skills Development Core Project Leader, and other participating senior 

o   Methods by which new investigators are to be recruited and selected including 
plans to recruit women and minority individuals.  

o   Plans for developing the skills of new investigators; the types of skill and 
technologic development proposed. 

o   Means by which the new investigators' professional development will be achieved. 
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will 
also be reviewed with respect to the following:

o   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.

o   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)

o   DATA SHARING: The adequacy of the proposed plan to share data.

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


Letter of Intent Receipt Date: August 17, 2004
Application Receipt Date: September 21 , 2004
Peer Review Date: January / February 1, 2005          
Council Review: May/September, 2005
Earliest Anticipated Start Date: January 1, 2006


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

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.

Phase I and II clinical trials must include provisions for assessment of patient 
eligibility and status, rigorous data management, quality assurance, and auditing 
procedures. In addition, it is NIH policy that all clinical trials require data and 
safety monitoring, with the method and degree of monitoring being commensurate with 
the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and 
Contracts, June 12, 1998: 

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 
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, 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 

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 

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs 
can be found at http://stemcells.nih.gov/index.asp and at 
https://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, in the project description and elsewhere 
in the application as appropriate, 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.

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 

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.

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 RFA 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 No. 93.837, 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 
https://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.

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