RESEARCH ON STEM CELL BIOLOGY AND CELL-BASED THERAPIES FOR HEART, LUNG, 
BLOOD, AND SLEEP DISORDERS
 
RELEASE DATE:  March 18, 2002
 
RFA:  HL-02-019
 
National Heart, Lung and Blood Institute (NHLBI) 
 (http://www.nhlbi.nih.gov)
 
LETTER OF INTENT RECEIPT DATE: August 20, 2002
APPLICATION RECEIPT DATE: September 20, 2002
 
THIS RFA CONTAINS THE FOLLOWING INFORMATION

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:

PURPOSE OF THIS RFA 

The National Heart, Lung, and Blood Institute invites research grant 
applications to conduct research on stem cell biology and cell-based 
therapies for the treatment of cardiovascular, lung, blood, and sleep 
disorders and diseases.  This initiative is intended to provide the 
scientific basis needed to accelerate translational research efforts 
leading to the use of cellular therapies for regenerative and 
reparative medicine.
 
RESEARCH OBJECTIVES

Background

There are no effective therapies for many acquired and congenital 
cardiovascular, pulmonary, hematologic, and sleep disorders and 
diseases.  Recent discoveries in stem cell biology present new 
opportunities for the use of cell-based therapies in disease areas with 
critical, unmet medical needs.  Adult, cord blood, embryonic and fetal 
stem cells hold great potential for use in new strategies aimed at the 
regeneration and repair of damaged or diseased cardiovascular, lung, 
and blood tissues and may have potential value for improving treatment 
of sleep disorders.

The plasticity of adult stem cells offers great promise as cell-based 
therapies. Hematopoietic stem cells give rise to all blood cells and 
have been used to treat serious blood disorders, malignant disease, and 
inherited diseases.  It has been demonstrated that hematopoietic stem 
cells can differentiate into cardiac muscle cells, vascular cells, lung 
epithelium, neural cells, glial cells and other cell lineages.  
Recently the ability of transplanted or mobilized hematopoietic stem 
cells to engraft and repair heart muscle and vascular tissue damaged by 
ischemia has been demonstrated in animal models.  In addition, bone 
marrow derived cells have been demonstrated to engraft as alveolar type 
1 epithelial cells and as bronchial epithelial cells.  Although 
hematopoietic and neuronal stem cell transplantation has not yet been 
applied to correcting central nervous system abnormalities associated 
with sleep disorders, such strategies potentially may have efficacy.  

Cardiovascular and lung tissues may also contain progenitor or stem 
cells that under the correct conditions could be induced to proliferate 
and repair cellular damage.  For instance, recent findings suggest a 
sub-population of fetal proliferative alveolar epithelial stem cells is 
present in adult lung.  In addition, other tissues such as skin, liver, 
brain, and muscle have progenitor or stem cell populations that may 
provide additional sources of cells for cellular therapies.  

The derivation of human embryonic stem (ES)cells has opened new avenues 
for using these cells for cellular therapies.  The National Institutes 
of Health has recently outlined the implementation of federal funding 
for human ES cell research.  ES cells are thought to be a truly 
pluripotent stem cell capable of self-renewal, can differentiate into 
all three germ cell layers, and have been shown to form hematopoietic 
cells and cardiomyocytes. Cells with these properties hold the promise 
of being able to repair or replace cells or tissues that are damaged or 
destroyed by many of the most devastating diseases and disabilities.
 
One of the current advantages of using ES cells, as compared to adult 
stem cells, is that ES cells will proliferate in vitro, and have been 
used to generate a broad range of cell types through directed 
differentiation.  It will be necessary to both identify the optimal 
stage(s) of differentiation for transplant, and demonstrate that the 
transplanted ES cell derived cells can survive, integrate, and function 
in the recipient.  Currently, a major research goal is the control of 
the differentiation of human ES cell lines into specific kinds of 
cells, an objective that must be met if the cells are to be used as the 
basis for therapeutic transplantation, testing drugs, or screening 
potential toxins. 

Research Scope

Clearly, the potential benefits of ES and adult stem cells to human 
health are immense.  Combinations of blood cell lineages could be 
engineered to address specific patient needs and stem cells could be 
expanded to provide a crucial supply of universally matched, pathogen-
free blood for transfusion.  Since differentiated derivatives of stem 
cells could provide a unique supply of cells for transplantation, 
research to elucidate and understand the differentiation of these cells 
into specific cell types is critical.  For tissue engineering 
applications, stem cells could be grown as biological substitutes for 
damaged and diseased cardiovascular, lung, or neural tissue, but 
understanding how to manipulate stem cells in order to grow biological 
substitutes is far from complete.  If a patient's own cells can be used 
to repair or regenerate damaged tissue, then understanding how to 
direct their stem cells or progenitors to the necessary cell lineages 
and tissue sites may be of key importance to the success of 
regenerative medicine.  If the patient is to receive allogeneic stem 
cells, the questions of HLA-matching, immunosuppression, transplant 
rejection must be addressed.  The number of stem cells available could 
limit clinical transplant applications and methods of obtaining, 
expanding and mobilizing stem cells need to be addressed.  The 
durability of stem cell grafts also needs to be addressed to determine 
the length of time a cell-based therapy could benefit a patient.

At a more fundamental level, stem cell differentiation could aid in the 
understanding of human cardiovascular, lung, blood, or neural 
development and lead to the identification of new cell differentiation 
factors. The regulation of hematopoietic stem cells may be mediated by 
different neurotransmitter mechanisms under conditions of sleep 
deprivation.  Some serious cardiovascular and lung conditions, such as 
congenital heart defects and bronchopulmonary dysplasia, result from 
abnormal cell differentiation or arrested growth.  A better 
understanding of the process of normal cell differentiation will allow 
further delineation of the fundamental errors that cause these 
diseases.

It is anticipated that this initiative will focus on fundamental 
research on cell-based therapies directed at regenerative and 
reparative medicine for heart, lung, blood and sleep disorders and 
diseases.  It is envisioned that areas of research supported under this 
initiative would include studies of the biology and characterization of 
embryonic, fetal and adult stem cells and progenitor cells important 
for heart, lung, blood and sleep disorders; studies of the use and 
differentiation of stem and progenitor cells for cell transplantation; 
and studies of stem cell homing to sites of tissue injury or specific 
tissue or organ sites, including the mechanisms underlying the homing 
process.

Projects must focus on studies which could lead to cell-based therapies 
for heart, lung, blood, or sleep disorders or diseases.  The potential 
relevance to specific diseases or disorders should be presented, and 
should be a consideration in the design of the research plan.  Within 
this context, projects may include, but are not limited to, research in 
the following areas:

o Stem and progenitor cell biology, evaluating and comparing a variety 
of cell sources and addressing their potential, frequency, 
availability, compatibility, trafficking or homing, and engraftment.  
This includes, but is not limited to, stem cells, progenitor cells, and 
embryonic stem cells.  Studies could include gene expression profiling 
for a variety of cell types.

o Determination of the best source of stem cells for cell-based 
therapies such as comparison of somatic (adult) stem cells and ES 
cells.

o Issues affecting the utility of various stem cells for cellular 
therapy, such as the rarity of adult stem cells, presence of infectious 
agents in stem cell populations, and the tumorigenic potential of ES 
cells.

o Stem cell identification, isolation, purification, in vitro (ex vivo) 
expansion, and immortalization.

o Manipulation of stem cell self-renewal and commitment.

o Role of growth factors, cytokines, receptors, transmembrane 
signaling, marrow stroma and microenvironment, and adhesive proteins in 
stem cell interactions and hematopoiesis.

o Stem cell transplantation, stem cell mobilization, and in situ 
activation of resident tissue stem cells.

o Enhancing stem cell engraftment through manipulation of stem and 
progenitor cell homing receptors in the target organ and on the stem 
cell surface.

o Development of animal models for cell-based therapy using stem cells.

o Histocompatibility and allo-interactions, mechanism of induction of 
transplant tolerance, minimizing the graft vs. host effect and graft 
rejection.

Projects may not include research in the following areas:

o Applications including research on somatic cell nuclear transfer, 
also known as nuclear transfer, will not be eligible for consideration 
and will be returned to the applicant.
 
MECHANISM OF SUPPORT
 
This RFA will use NIH individual research project grants (R01) award 
mechanism.  As an applicant you will be solely responsible for 
planning, directing, and executing the proposed project.  This RFA is a 
one-time solicitation.  Future unsolicited, competing-continuation 
applications based on this project will compete with all investigator-
initiated applications and will be reviewed according to the customary 
peer review procedures.  The anticipated award date is July 1, 2003.

This RFA uses just-in-time concepts.  It also uses the modular as well 
as the non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  
Specifically, if you are submitting an application with direct costs in 
each year of $250,000 or less, use the modular format.  Otherwise 
follow the instructions for non-modular research grant applications.

FUNDS AVAILABLE

The National Heart, Lung, and Blood Institute (NHLBI) intends to commit 
approximately $8 million in FY 2003 to fund 12 to 15 new and/or 
competitive continuation grants in response to this RFA. An applicant 
may request a project period of up to four years and a budget for 
direct costs of up to $350,000 per 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. At this time, it is not known if this RFA 
will be reissued.
 
ELIGIBLE INSTITUTIONS
 
You may submit (an) application(s) if your institution has any of the 
following characteristics:
	
o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, 
hospitals, and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic or foreign
 
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS   

Any individual with the skills, knowledge, and resources necessary to 
carry out the proposed research is invited to work with their 
institution to develop an application for support.  Individuals from 
underrepresented racial and ethnic groups as well as individuals with 
disabilities are always encouraged to apply for NIH programs.   
 
SPECIAL REQUIREMENTS
 
In order to be responsive to this RFA, applications must focus on 
studies which could lead to cell-based therapies for heart, lung, 
blood, or sleep disorders or diseases.  The potential relevance to 
specific diseases or disorders must be presented, and should be a 
consideration in the design of the research plan. In addition, 
applications including research on somatic cell nuclear transfer, also 
known as nuclear transfer, will not be eligible for consideration and 
will be returned to the applicant.
 
Upon initiation of the program, the NHLBI will sponsor annual meetings 
to encourage the exchange of information among investigators who 
participate in this program, perhaps in conjunction with other 
Institute sponsored cell-based therapy or stem cell programs.  In the 
preparation of the budget for the grant application, applicants should 
include travel funds for the one meeting each year to be held in 
Bethesda, Maryland.  Applicants should also include a statement in the 
applications indicating their willingness to participate in such 
meetings.

WHERE TO SEND INQUIRIES

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

o Direct your questions about scientific/research issues to:

Dr. John W. Thomas
Division of Blood Diseases and Resources / NHLBI
6701 Rockledge Drive /Room 10154 / Mail Stop 7952
Bethesda, MD  20892-7950
Telephone:  (301) 435-0050
FAX:  (301) 451-5453
Email:  ThomasJ@nhlbi.nih.gov

Dr. Mary Ann Berberich 					
Division of Lung Diseases / NHLBI							
6701 Rockledge Drive /Room 10102 / Mail Stop 7952
Bethesda, MD  20892-7952
Telephone:  (301) 435-0222
FAX:  (301) 480–3557
E-mail:  BerberiM@nhlbi.nih.gov 

Dr. John Fakunding 					
Division of Heart and Vascular Diseases / NHLBI							
6701 Rockledge Drive /Room 9170 / Mail Stop 7940
Bethesda, MD  20892-7940
Telephone:  (301) 435-0494
FAX:  (301) 480–1336
E-mail:  FakundiJ@nhlbi.nih.gov

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

Marsha Mathis
National Heart, Lung, and Blood Institute
6701 Rockledge Drive / Room 7158 / Mail Stop 7926
Bethesda, MD  20817-7926
Telephone:  (301) 435-0170
FAX:  (301) 480-3310
Email:  MathisM@nhlbi.nih.gov 
 
LETTER OF INTENT
 
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 NHLBI 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 to:

Anne P. Clark, Ph.D.
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7178 (MSC 7924)
Bethesda, MD  20892-7924 (20817 for Courier)
Telephone:  (301) 435-0270
Fax:  (301) 480-0730
Email:  ClarkA@nhlbi.nih.gov 

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001).  The PHS 398 is 
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in 
an interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.
 
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications 
requesting up to $250,000 per year in direct costs must be submitted in 
a modular grant format.  The modular grant format simplifies the 
preparation of the budget in these applications by limiting the level 
of budgetary detail.  Applicants request direct costs in $25,000 
modules.  Section C of the research grant application instructions for 
the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-
by-step guidance for preparing modular grants.  Additional information 
on modular grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

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: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
 
SENDING AN APPLICATION TO THE NIH: 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 sets of the appendix material must be sent to:
 
Anne P. Clark, Ph.D.
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7178 (MSC 7924)
Bethesda, MD  20892-7924 (20817 for Courier)
Telephone:  (301) 435-0270
Fax:  (301) 480-0730
Email:  ClarkA@nhlbi.nih.gov 
 
APPLICATION PROCESSING: 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 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 sent 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 Submitting an Application.

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the (IC). 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 (IC) in accordance with the review 
criteria stated below.  As part of the initial merit review, all 
applications will:

o Receive a written critique
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 second level review by the Heart, Lung and Blood National 
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 the written comments, reviewers will be asked to discuss the 
following aspects of your application in order to judge the likelihood 
that the proposed research will have a substantial impact on the 
pursuit of these goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The scientific review group will address and consider each of these 
criteria in assigning your application's overall score, weighting them 
as appropriate for each application.  Your application does not need to 
be strong in all categories to be judged likely to have major 
scientific impact and thus deserve a high priority score.  For example, 
you may propose to carry out important work that by its nature is not 
innovative but is essential to move a field forward.

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

(2) APPROACH:  Are the conceptual framework, design, methods, and 
analyses adequately developed, well integrated, and appropriate to the 
aims of the project?  Do you acknowledge potential problem areas and 
consider alternative tactics?

(3) INNOVATION:  Does your project employ novel concepts, approaches or 
methods? Are the aims original and innovative?  Does your project 
challenge existing paradigms or develop new methodologies or 
technologies?

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

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

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, 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 BUDGET:  The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  August 20, 2002.
Application Receipt Date:  September 20, 2002.
Peer Review Date:  February/March 2003.
Council Review:  May 29-30, 2003.
Earliest Anticipated Start Date:  July 1, 2003.

AWARD CRITERIA

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.
 
REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD:  Research 
components involving 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: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

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

All investigators proposing clinical research should read the AMENDMENT 
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research - Amended, October, 2001," published in the NIH Guide 
for Grants and Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a 
complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2
001.htm.  The amended policy incorporates: the use of an NIH 
definition of clinical research; updated racial and ethnic categories 
in compliance with the new OMB standards; clarification of language 
governing NIH-defined Phase III clinical trials consistent with the new 
PHS Form 398; and updated roles and responsibilities of NIH staff and 
the extramural community.  The policy continues to require for all NIH-
defined Phase III clinical trials that: a) all applications or 
proposals and/or protocols must provide a description of plans to 
conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups if applicable; and b) 
investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

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

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

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

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

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

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

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

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance No. 93.839, 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 http://grants.nih.gov/grants/policy/policy.htm and under Federal 
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 

The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and discourage the use of all tobacco products.  In 
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits 
smoking in certain facilities (or in some cases, any portion of a 
facility) in which regular or routine education, library, day care, 
health care, or early childhood development services are provided to 
children.  This is consistent with the PHS mission to protect and 
advance the physical and mental health of the American people.

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