SPECIALIZED CENTERS OF RESEARCH (SCOR) IN NEUROBIOLOGY OF SLEEP AND SLEEP APNEA 
AND AIRWAY BIOLOGY AND PATHOGENESIS OF CYSTIC FIBROSIS

Release Date:  December 11, 2001

RFA:  RFA-HL-02-013

National Heart, Lung, and Blood Institute
 (http://www.nhlbi.nih.gov)

Letter of Intent Receipt Date:  September 11, 2002
Application Receipt Date:       October 11, 2002

PURPOSE

The primary objective of the Specialized Centers of Research (SCOR) programs 
is to foster multidisciplinary basic and clinical research enabling basic 
science findings to be more rapidly applied to clinical problems.  The basic 
and clinical research to be supported through this RFA will be related to one 
of the above two categories.  It is expected that results from these SCOR 
grants will have an impact on the prevention, diagnosis, and treatment of 
disorders of sleep and cystic fibrosis.  This is the second and final 5-year 
solicitation for these two SCOR programs. 

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 Request for Applications (RFA), 
Specialized Centers of Clinical Research, 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/.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by for-profit and nonprofit domestic 
institutions, public and private, such as universities, colleges, hospitals, 
and laboratories.  Awards will not be made to foreign institutions.  However, 
under exceptional circumstances, a foreign component critical to a project may 
be included as a part of that project.  Women and minority investigators are 
encouraged to apply. 

This RFA is intended to support SCOR grants for basic and clinical 
investigations.  Applications that include only basic or only clinical 
research will not be responsive to this announcement.  Each awarded SCOR must 
consist of three or more projects, all of which are directly related to the 
SCOR program topic. 

MECHANISM OF SUPPORT

This RFA will use the NHLBI SCOR (P50) grant to support this research program. 
 Applications received in response to the Neurobiology of Sleep and Sleep 
Apnea and Airway Biology and Pathogenesis of Cystic Fibrosis programs may be 
either new or renewal applications.  

Responsibility for the planning, direction, and execution of the proposed 
project will be solely that of the applicant.  All current policies and 
requirements that govern the research grant programs of the NIH will apply to 
grants awarded under the RFA.

Basic and Clinical Research

The overall concept of a SCOR program focuses on scientific issues related to 
diseases and disorders relevant to the mission of the NHLBI.  It is essential, 
therefore, that all applications include both basic and clinical research 
projects.  Interactions between basic and clinical scientists are expected to 
strengthen the research, enhance transfer of fundamental research findings to 
the clinical setting, and identify new research directions.  Plans for 
transfer of findings from basic to clinical studies should be described.

In order for a project to be considered clinical for the purposes of 
responsiveness to this RFA, the research must fit the definition of clinical 
research in the PHS 398 
(http://grants.nih.gov/grants/funding/phs398/phs398.html, parts 1 and 2, but 
not part 3).  That is, the research must be either patient-oriented research, 
or an epidemiologic or behavioral study.

For patient-oriented research, this is "research conducted with human subjects 
(or material of human origin such as tissues, specimens and cognitive 
phenomena) for which an investigator (or colleague) directly interacts with 
human subjects."  To be responsive, clinical investigations may include 
studies of subjects with the disease of interest as well as normal healthy 
subjects.  In studies involving the use of human specimens, e.g., blood, 
bronchoalveolar lavage, or biopsy, the investigators must have direct 
interaction with the subject or patient 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.

Human biomedical and behavioral studies of etiology, pathogenesis, prevention 
and prevention strategies, diagnostic approaches, and treatment of diseases, 
disorders or conditions are also responsive.  Small population-based 
epidemiologic studies, where the research can be completed within 5 years, may 
also be proposed.  However, clinical research projects focused on large 
epidemiologic studies or Phase III clinical trials will be considered 
unresponsive to this RFA. 

In addition, basic research projects must be included that relate to the 
clinical focus.  A SCOR may also contain one or more core units that support 
the research projects.  A core cannot be counted as a clinical project.

Applicants should provide a detailed data and safety monitoring plan for the 
clinical research proposed; the monitoring plan will be considered as part of 
the 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.  The NIH Policy for Data and 
Safety Monitoring can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html.  
There may be isolated cases when the Institute may 
wish to convene a DSMB to oversee the clinical projects in a SCOR program.  
This will be determined after review and selection of the SCOR centers. 

Principal Investigator (SCOR Director) and Project Leaders

The principal investigator should be an established research scientist with 
the ability to ensure quality control and the experience to administer both 
basic and clinical 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 SCOR 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.  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. 

Length of SCOR Programs

Each NHLBI SCOR 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 SCOR 
program.

Under this policy, a given SCOR 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 SCOR program is 
recommended for extension. 

The NHLBI comprehensive evaluation of the Neurobiology of Sleep and Sleep 
Apnea and Airway Biology and Pathogenesis of Cystic Fibrosis SCOR programs 
will be conducted during the second project period according to the following 
timetable:  

Program Announced:                    FY 1996
Project Period (First Competition):   FY 1998 through FY 2003
Program Reannounced:                  FY 2002
Project Period (Second Competition):  FY 2003 through FY 2008
Letter to SCOR Directors Regarding 
SCOR Evaluation Plans:                FY 2005 (mid-way through year 02 of 2nd 
                                        project period)
SCOR Evaluation Meeting:              FY 2005 (late in year 02 of 2nd 
                                        project period)

The NHLBI does not limit the number of SCOR applications in a given SCOR 
program from one institution nor does it limit the number of applications in 
the two SCOR programs described in this announcement from one institution.  
However, there must be a different SCOR principal investigator for each 
application and each application must be self-contained and independent of the 
other(s).  This does not preclude cooperation planned or possible among 
participants of SCORs after awards are made.  Scientific overlap among 
applications will not be accepted.  If more than one application in a given 
program is envisioned from an institution, the institution is encouraged to 
discuss its plans with the NHLBI SCOR program administrator. 

FUNDS AVAILABLE

For new applications, the applicants may request up to $1,420,000 direct 
costs, not including   facilities and administrative costs for collaborating 
institutions, in the first year, and for renewal applications, the applicants 
may request a ten (10) percent increase over the last year of the preceding 
project period or a total of $1,420,000, whichever is less.  An increase of no 
more than 3 percent may be requested in each additional year.  Award of grants 
pursuant to this RFA is contingent upon availability of funds for this 
purpose.  It is estimated that a total of $11,600,000 will be available for 
the first year of support for the two programs and it is anticipated a total 
of up to seven awards will be made.

Equipment is included in the budget limitation.  However, requests for 
expensive special equipment that cause an application to exceed this limit may 
be permitted on a case-by-case basis following staff consultation.  Such 
equipment requests require in-depth justification. Final decisions will depend 
on the nature of the justification and the Institute's fiscal situation. 

Consortium Arrangements

If a grant application includes research activities that involve institutions 
other than the grantee institution, the program is considered a consortium 
effort.  Such applications are permitted, but it is imperative that a 
consortium application be prepared so that the programmatic, fiscal, and 
administrative considerations are explained fully.  The published policy 
governing consortia is available in the business offices of institutions that 
are eligible to receive Federal grants-in-aid.  Consult the latest published 
policy governing consortia before developing the application.  For 
clarification of the policy, contact Mr. Ray Zimmerman, Grants Operations 
Branch, NHLBI, 301-435-0171.  Applicants of SCOR grants should exercise great 
diligence in preserving the interactions of the participants and the 
integration of the consortium project(s) with those of the 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. 

RESEARCH OBJECTIVES

Background

The SCOR program was initiated within the Division of Lung Diseases in 1971 as 
a Pulmonary SCOR.  Since then, several modifications and changes in program 
direction have been made and new SCOR programs have been implemented.  As a 
result of a congressional mandate, two new SCOR programs, Cardiopulmonary 
Disorders During Sleep and Cystic Fibrosis, were announced in 1988, resulting 
in a total of five awards. In 1991 renewal programs in Cardiopulmonary 
Disorders of Sleep and Cystic Fibrosis were announced.  In FY 1993, a total of 
four awards were made for centers in Cardiopulmonary Disorders of Sleep and 
three in Cystic Fibrosis.

In response to the new Institute policy that each SCOR program is limited to 
10 years of support, unless a programmatic evaluation indicates that further 
support is warranted, the Division convened an evaluation committee in 1995 to 
review the SCOR programs in Cardiopulmonary Disorders of Sleep and Cystic 
Fibrosis.  They recommended that new SCOR programs be announced in 
Neurobiology of Sleep and Sleep Apnea and in Airway Biology and Pathogenesis 
of Cystic Fibrosis.  In fiscal year 1998 three awards were made for centers in 
Neurobiology of Sleep and Sleep Apnea and four awards in Airway Biology and 
Pathogenesis of Cystic Fibrosis.  This is the reannouncement for these two 
SCOR programs for the second 5 year period of funding. 

Justification for announcing a competition in the SCOR programs in 
Neurobiology of Sleep and Sleep Apnea and Airway Biology and in Pathogenesis 
of Cystic Fibrosis are based on the recommendations from the SCOR evaluation, 
on past accomplishments, which have been provided in reports from the Division 
and the Institute, and on opportunities for new research directions.  Funding 
for these two SCOR programs expires on August 31, 2003.  

Proposed Research 

Applications must be addressed to only one of the two categories identified in 
this announcement to be acceptable for this competition.  A SCOR grant is a 5-
year program, therefore, an applicant should submit a 5-year plan for all the 
projects.  If a project can be completed in less than 5 years, it should not 
be included in the application.  

Examples of research topics of interest for each SCOR program under 
competition are listed below.  These research topics are intended to provide a 
perspective of the scope of research that would meet the objectives of this 
program.  It is not required that all or any of these topics be included; 
investigators are encouraged to consider other topics that are relevant to the 
goals of these programs.   

Neurobiology of Sleep and Sleep Apnea  

The objective of this SCOR program is to integrate clinical research on the 
etiology and pathogenesis of sleep disorders, particularly sleep apnea, with 
molecular, cellular, and genetic approaches to the study of sleep.  
Neurobiological mechanisms underlying the relationship of sleep apnea to 
cardiovascular, pulmonary, hematological, endocrine, immunological, and other 
health consequences are also of interest.  The scope of the program includes 
repetitive episodes of complete or partial obstruction of the upper airway 
during sleep (sleep-disordered breathing).  The research topics identified 
below are offered as examples that would be responsive to this announcement.  

Sleep disordered breathing and snoring have been implicated as risk factors 
for the development of hypertension, ischemic heart disease, and cerebral 
infarction.  Research is needed to examine the pathophysiologic role of the 
nervous system in the association of sleep disordered breathing with heart, 
lung, and blood diseases.  Studies are also needed to elucidate neural 
mechanisms underlying the influence of sleep on cardiovascular, vascular, and 
immunological function.   

Since excessive daytime sleepiness is a major clinical consequence of sleep 
apnea, another important focus is to identify factors that can be quantified 
with minimally invasive procedures to assess sleep status, the sleep 
requirements of individuals, and the consequences of excessive daytime 
sleepiness on normal health and development.  The neurobiological basis of 
impaired daytime performance due to sleep disordered breathing also needs to 
be elucidated.  The development of new therapeutic strategies for the 
treatment of sleep disordered breathing and associated health consequences, 
particularly pharmacologic approaches, remains an important goal of this SCOR 
program.

Epidemiologic studies have provided new insights into the risks associated 
with sleep disordered breathing.  Studies are needed to better define the 
clinical threshold at which sleep disordered breathing presents significant 
health risks, and determine its predictors and antecedents, particularly in 
its early phases.  Evidence now suggests that the nature of sleep disturbances 
associated with sleep apnea in children may be different than in adults.  
Attention should be given to the relationship between pathologic and 
physiologic abnormalities, gender specific factors, and age.  Better objective 
measures and standardized criteria for sleep apnea, including associated 
morbidity and mortality also need to be investigated.  

Recent findings indicate that sleep disordered breathing and several other 
sleep disorders exhibit patterns of familial aggregation and suspected genetic 
predisposition.  Studies are needed to elucidate the genetic programs 
regulating normal human sleep and phenotypic variations in the amount, timing, 
architecture, and electrophysiologic characteristics of sleep.  Polymorphisms 
at multiple loci are likely to be involved, but very few studies have 
attempted to identify the underlying genetic factors or estimate the role of 
inheritance in human sleep disorders.  Mammalian genes with strong effects on 
endogenous circadian rhythmicity such as Clock have been identified in various 
tissues including brain, heart, and lung.  Genes encoding receptors and 
metabolic enzymes for neurotransmitters critically involved in the regulation 
of sleep (and in functions related to sleep disorders such as breathing and  
neuroendocrine/immune function) have been cloned and mapped.  Some of these 
genes are polymorphic, but whether these polymorphisms influence 
sleep/circadian rhythms in human populations, are associated with disorders 
such as sleep disordered breathing, or contribute to disease development or 
progression in other physiologic systems needs to be determined.  

The elucidation of neural pathways and the molecular processes regulating 
normal sleep and sleep disordered breathing continues to be an area of 
interest.  For example, molecular neurobiologic approaches should be applied 
to determine what neurons express sleep regulating factors, whether sleep 
disordered breathing changes the expression of sleep regulating factors, and 
to elucidate the regulatory signals involved in these events.  It is also 
important to determine how the levels of endogenous sleep regulating compounds 
vary with the sleep/wake cycle.  Studies are needed to investigate the 
neurobiologic significance of sleep disorders, particularly sleep apnea, in 
the maintenance of brain functions such as learning, and to characterize its 
role in neurologic disease processes.  Integrating clinical research on sleep 
apnea with the neurobiology of sleep will advance our understanding of major 
clinical consequences of sleep apnea, including excessive daytime sleepiness 
and increased risk of cardiovascular disease.    

Airway Biology and Pathogenesis of Cystic Fibrosis (CF)  

The Airway Biology and Pathogenesis of CF SCOR program seeks to develop 
multidisciplinary collaborations focused on fostering the translation of basic 
research to clinical applications.  Current knowledge of CFTR will be utilized 
to promote research advances on the pathogenesis of CF, the role of CFTR in 
airway biology, and the development of new prevention and treatment 
strategies.  Information on how CF begins and progresses in the airway with 
respect to inflammation and/or infection, and their inter-relationship, is 
particularly important as is understanding the role of host defense mechanisms 
and inflammatory mediators in preventing or contributing to pathogenesis.  
Novel therapeutic approaches directed at controlling these processes need to 
be developed and tested.  Understanding the nature of the vulnerability of CF 
patients to infection and excessive inflammation is critical for planning 
therapeutic strategies for CF patients at all stages of disease.  Further 
investigation is essential into the mechanisms generating and controlling the 
airway surface fluid (ASF), which may be critical to pulmonary homeostasis and 
lung defense, and how normal and mutant CFTR affect it.  Pertinent clinical 
data relevant to these responses need to be generated.  The contribution of 
the submucosal glands versus the surface epithelium to normal fluid and 
electrolyte balance and to the pathogenesis of CF needs to be determined.  
Information on stem or progenitor cells in the airways is critical to our 
understanding of basic aspects of lung biology and would be helpful for 
therapeutic approaches.  Our knowledge of the biology, structure and function 
of normal and mutant CFTR remains superficial.  The interaction of CFTR with 
other membrane and cellular proteins needs to be defined, as well as its 
functional consequences.  Factors other than the primary defect in CFTR govern 
the fate of patients with CF such as environmental factors, the acquisition of 
certain infections, bacterial gene products, and genetic modifiers of the CF 
phenotype.  These factors need to be identified and characterized.    

New therapies are needed which correct the primary defect or activate 
alternative pathways to prevent airway disease.  Thus, there is a critical 
need to translate the new knowledge regarding the pathogenesis of CF and the 
function of CFTR into new treatment strategies.  The development of novel 
pharmacologic and gene therapies are important, such as the development of 
agents which correct defective CFTR, enhance expression or activity of CFTR, 
facilitate trafficking of CFTR to the apical cell membrane, or interfere with 
bacterial colonization.  Barriers to persistent correction of defective CFTR 
function such as vector-induced inflammatory and immune responses and low 
efficiency of airway cell transduction should be eliminated.  Identification 
of appropriate lung cell targets for gene transfer such as progenitor, surface 
and submucosal gland cells is important.  Translational research is essential 
for potential treatment modalities resulting from ongoing pathophysiologic 
analyses of cytokines, chemoattracants, adhesion molecules and other potential 
immunotherapies; gene therapy; mucus production and composition; natural 
peptide antibiotics (e.g., defensins); and alternative ion channels.   

A better understanding would be helpful of the processes of protein processing 
and degradation operative in CF airways and pharmacologic interventions to 
disrupt downstream pathology.  As potential sites of therapeutic targets 
designed to provide alternate pathways for fluid production in CF airways, it 
would be important to study alternate ion channels, uncover new receptors 
which control lung function and develop methods of overcoming aberrant 
processing of mutant CFTR.  The molecular and physiologic defects in CF need 
to be linked with the clinical aspects of CF lung disease.   

SPECIAL REQUIREMENTS

Special features of SCOR grants are:

o  They provide opportunities for investigators with mutual or complementary 
interests to engage in multidisciplinary research focusing on a specific 
respiratory disorder.

o  Inherent in the SCOR program is a special interaction among the principal 
investigator, the grantee institution and the Division of Lung Diseases.  
Funds are specifically allocated in a SCOR grant for investigators from 
different SCORs to meet and discuss problems of mutual  interest and to 
participate in workshops addressing common research areas.

o  The Division's SCOR programs undergo periodic evaluations.

Requirements of SCOR grants:

1.  Research conducted at the individual centers must include both basic and 
clinical research to ensure that advances in the basic sciences are translated 
rapidly into clinical applications and that clinical needs will provide a 
direction for the basic research.  Therefore, each SCOR grant application and 
award must include one or more clinical research project(s) as specified under 
the section "Basic and Clinical Research."  The basic research projects should 
clearly relate to the disease focus and contribute to elucidation of 
mechanisms underlying the disease, or to improved diagnosis or management of 
the disease.

2.  Each component project whether basic or clinical requires a well-described 
clinically relevant hypothesis, preliminary data and a time-table for 
conducting the proposed investigations.  

3.  The relationship of each core to the research projects should be 
described.  A core cannot be counted as a clinical project.

4.  The principal investigator (SCOR director) should be an established 
scientist with the ability to ensure quality control and the experience to 
administer basic and clinical 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 also be the 
project leader of one of the component research projects.  If this project is 
not recommended by peer review, the overall SCOR application will not be 
considered further.  If this project is judged by peer review to be of low 
scientific merit, it will markedly reduce the overall scientific merit ranking 
assigned to the entire application by the review committee.  

5.  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.  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.

6.  Each SCOR must have a well-delineated organizational structure and 
administrative mechanism that foster interactions between investigators, 
accelerate the pace of research, and ensure a productive research effort.  

7.  If a project leader transfers to another institution, support for the 
project will normally not be continued as a consortium.

Because of the size and complexity of a SCOR, prospective applicants are urged 
to consult with the staff of the Division of Lung Diseases early in the 
preparation of the application (see INQUIRIES Section).  To provide 
opportunity for such interactions, the time frame for implementation of this 
program includes an ample interval between the release of this RFA, and the 
receipt date for applications.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

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.

NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN 
RESEARCH INVOLVING HUMAN SUBJECTS

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 and Type 2) 
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 
address:  http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

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.  This policy announcement is found in the NIH Guide for Grants and 
Contracts Announcement dated June 5, 2000, at the following website:  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.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. Reviewers are cautioned that their anonymity may be compromised when 
they directly access an Internet site. 

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 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. 

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes a 
descriptive title of the proposed research, the name, address, and telephone 
number of the principal investigator, the names of participating institutions, 
the identities of other key personnel, and the number and title of the RFA 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 subsequent applications, it assists the NHLBI staff 
to estimate the potential review workload and plan the review.

The letter of intent is to be sent to the Chief, Review Branch, listed under 
Inquiries no later than September 11, 2002.

APPLICATION PROCEDURES

The PHS 398 research grant application instructions and forms (rev. 5/2001) 
available at http://grants.nih.gov/grants/funding/phs398/phs398.html must be 
used in applying for these grants. This version of the PHS 398 is available in 
an interactive, searchable format.  For further assistance contact GrantsInfo, 
Telephone 301-435-0714, Email:  GrantsInfo@nih.gov.  Special instructions are 
needed for preparing a SCOR application and are available from the program 
contact listed under Inquiries or at 
http://www.nhlbi.nih.gov/funding/inits/dldscor.htm.

Plans for data safety monitoring must be included for the clinical research 
proposed.  Applicants should describe the organizational structures and 
procedures they will employ to ensure the safety of participants and the 
validity and integrity of the data; for a statement of issues and concerns, 
see NIH Policy for Data and Safety Monitoring, NIH guide to Grants and 
Contracts, Release Date:  June 10, 1998, 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html.  At the time 
of the award, applicants should be prepared to make adjustments to their 
procedures based upon NHLBI policy.  

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:  
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

Submit a signed, typewritten original of the application, including the 
Checklist, and three 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)

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 Chief, Review 
Branch, at the address listed under Inquiries.  Applications must be received 
by 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.  The 
CSR also will not accept any application that is essentially the same as one 
already reviewed.  This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must include 
an Introduction addressing the previous critique.

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 do not receive such a letter within three weeks after 
submitting the application, contact Dr. Deborah Beebe at the address listed 
under Inquiries.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by CSR and 
responsiveness by the NHLBI staff.  Incomplete applications or applications 
deemed not responsive to the RFA will be returned to the applicant without 
further consideration.  Applications that are submitted with only basic or 
only clinical research will be considered nonresponsive. 

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.  APPLICANTS 
SHOULD SUBMIT THE HIGHEST QUALITY APPLICATIONS POSSIBLE TO CSR AS NO SITE 
VISITS NOR REVERSE SITE VISITS WILL BE HELD.  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.  

Factors to be considered in the evaluation of each application will be similar 
to those used in review of traditional research grant applications and, in 
addition, will include overall proposed interactions among basic and clinical 
research projects.  Major factors to be considered in the evaluation of 
applications include:  

1.  Scientific merit of the proposed basic and clinical 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.

2.  Leadership, scientific stature, 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.

3.  Collaborative interaction among basic and clinical research components, 
the required clinical research component, and plans for transfer of potential 
findings from basic to clinical studies.

4.  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. 

5.  Adequacy of the data and safety monitoring plan for the clinical research 
proposed.

Each project will receive a priority score.  Each 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.

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.  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.

o  The adequacy of the proposed plan to share data.  

AWARD CRITERIA

The anticipated date of award is September 30, 2003 (FY2003) for these two 
SCOR programs. A major factor guiding the Institute in selecting which 
applications to fund will be the strength of the clinical research and its 
integration with the basic research.  Applications with weak clinical research 
will unlikely be funded, regardless of the overall priority score.   
Availability of funds and programmatic priorities will also be factored into 
funding decisions.

INQUIRIES

Written and telephone inquiries concerning the RFA are encouraged.  The 
opportunity to clarify any issues or questions from potential applicants is 
welcome.  Special supplemental instructions for the preparation of grant 
applications for SCORs may be obtained by contacting program staff at the 
Division of Lung Diseases, as indicated below.

Direct inquiries regarding programmatic issues to:

Neurobiology of Sleep and Sleep Apnea

Michael Twery, Ph.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, MSC 7952
Bethesda, Maryland  20892-7952
Telephone:  (301) 435-0202
Fax:  (301) 480-3557
Email:  Twerym@nhlbi.nih.gov

Airway Biology and Pathogenesis of Cystic Fibrosis

Susan Banks-Schlegel, Ph.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, MSC 7952
Bethesda, Maryland  20892-7952
Telephone:  (301) 435-0202
Fax:  (301) 480-3557
Email:  Schleges@nhlbi.nih.gov

Direct inquiries regarding review issues, send letter of intent, and two 
copies of the application to:

Chief, Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7178(MSC 7924)
Bethesda, Maryland  20892-7924
Telephone:  (301) 435-0270
Fax:  (301) 480-3541
Email:  Db57j@nih.gov

Direct inquiries regarding fiscal matters to:
Raymond Zimmerman
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, MSC 7926
Bethesda, Maryland  20892-7926
Telephone:  (301) 435-0171
Fax:  (301) 480-3310
Email:  rv7g@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.838.  Awards are made under authorization of Sections 301 and 405 of the 
Public Health Service Act as amended by Public Health Service Act (42 USC 241 
and 284) 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 Public Health Service (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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