ASTHMA AND ALLERGIC DISEASES RESEARCH CENTERS

RELEASE DATE:  April 11, 2002

RFA: AI-02-007 (This RFA has been reissued, see RFA-AI-05-027)

National Institute of Allergy and Infectious Diseases (NIAID) 
 (http://www.niaid.nih.gov)

LETTER OF INTENT RECEIPT DATE: October 11, 2002
APPLICATION RECEIPT DATE: November 13, 2002

APPLICATIONS IN RESPONSE TO THIS REQUEST FOR APPLICATIONS (RFA) MUST BE 
PREPARED USING A MULTI-PROJECT GRANT APPLICATION FORMAT; SPECIFIC INSTRUCTIONS 
FOR COMPLETING THE APPLICATION ARE IN THE NIAID BROCHURE ENTITLED 
"INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS" WHICH IS AVAILABLE AT 
THE FOLLOWING LINK:  http://www.niaid.nih.gov/ncn/grants/multibron.htm

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism(s) 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 NIAID Asthma and Allergic Diseases Research Centers (AADRC) program was 
established nearly three decades ago to promote innovative, multidisciplinary 
basic and clinical research on asthma and allergic diseases.  NIAID currently 
supports 13 extramural AADRCs, two of which are co-funded by the National 
Institute of Environmental Health Sciences.  Four of the NIAID centers will 
expire in FY 2003, and the purpose of this RFA is to solicit new and 
competitive continuation applications for AADRCs.  The program is intended to 
provide support for integrated basic and clinical research centers to conduct 
studies on the mechanisms underlying the onset and progression of asthma and 
allergic diseases.  The overarching goal of the program is to improve the 
diagnosis and treatment of asthma and allergic diseases and to provide a 
rational foundation for the development of effective prevention strategies. 
Applications must be structured around a central scientific theme that is 
clearly relevant to asthma and/or allergic diseases.  A minimum of three 
research projects must be recommended for funding by the Internal Review Group 
(IRG), and at least one of those recommended projects must focus on 
immunologic aspects of asthma and/or allergic diseases in humans.  All 
applicants must comply with this stipulation and the others described in the 
section of this RFA entitled "SPECIAL REQUIREMENTS."

RESEARCH OBJECTIVES

Background

Asthma affects more than 11 million Americans, resulting in more than 130 
million days of restricted activity, approximately 500,000 hospitalizations 
and over 5000 deaths each year.  Allergic rhinitis and chronic sinusitis, two 
of the most commonly reported chronic diseases, together affect approximately 
75 million Americans, and chronic sinus disease is frequently associated with 
asthma.  The morbidity and mortality associated with asthma are 
disproportionately high among children, particularly those who reside in the 
inner city. African Americans are hospitalized for asthma three times more 
often than other Americans, and African Americans and Hispanic Americans 
living in inner cities are two to six times more likely to die from asthma.  
Although the mortality associated with asthma and allergic diseases is low, 
the economic burden is high, with an estimated cost for asthma in the United 
States of $12.7 billion in 1998 and more than $5.8 billion for sinusitis in 
1996.  In spite of recent advances in understanding the mechanisms underlying 
asthma and allergic diseases, and improvements in medications used to treat 
these diseases, the adverse impact on public health continues to grow.  For 
example, the prevalence of asthma has increased by more than 80% in all age 
and ethnic groups over the past two decades.  In order to reverse this trend, 
it will be necessary to continue to improve our understanding of the cellular 
and molecular events that lead to the onset of asthma and allergic diseases 
and the mechanisms involved in disease progression.   This new knowledge is 
required for the development of novel approaches to treat and, eventually, 
prevent these diseases.

Research during the past two decades has led to significant advances in 
understanding the mechanisms involved in the pathogenesis of asthma and 
allergic diseases but has had only a modest impact on therapy.  Currently, the 
management of asthma is complex and treatment regimens for rhinitis and 
sinusitis are aimed at controlling inflammation and alleviating symptoms.  
Effective control of asthma is difficult to maintain because patients are 
required to comply with daily, multi-drug regimens, and severe asthma is often 
difficult to control, even with an optimal management plan. In addition, most 
of the drugs currently used to treat asthma have a number of undesirable side 
effects and, in some cases, overuse can actually lead to worsening of the 
disease.  A growing body of evidence suggests that abnormal function of the 
immune system is central to the pathogenesis of asthma, as is the case with 
allergic diseases.  Recent studies have suggested that perturbations of immune 
function during gestation and infancy "prime" for the development of asthma 
and allergy, and that expression of the diseases occurs as a result of 
exposure to environmental factors, including airborne allergens.

Basic research in this area has largely focused on chronic respiratory tract 
inflammation, which is an important clinical feature of asthma and allergic 
rhinitis; however, much of this work has been limited to studies involving 
animal models.  This body of research has begun to reveal the complex cellular 
and molecular interactions that contribute to inflammation in these diseases 
and has led to the identification of several promising targets for 
intervention, including IgE antibody and the pro-inflammatory cytokines IL-4, 
IL-5 and IL-13. In fact, clinical trials are now being conducted to evaluate 
the efficacy of anti- IgE in asthma and allergen-conjugated immunostimulatory 
DNA sequences in allergic rhinitis. Many of these clinical leads are the 
direct result of research funded through the AADRC program. Such therapeutic 
approaches that target discrete molecules or pathways promise to be effective 
and specific, without the side effects and limitations of current treatments.

Nevertheless, significant gaps in knowledge persist.  For example, little is 
known about the cellular and molecular immune mechanisms that contribute to 
the acute airway obstruction characteristic of an asthma exacerbation, which 
requires patients to use beta-adrenergic rescue medications and/or seek 
emergency medical treatment.  Although it is likely that the contraction of 
airway smooth muscle is involved, the specific immune pathways, chemical 
mediators and/or neuroimmune mechanisms that trigger and regulate the process 
in humans are poorly understood.  Furthermore, airway obstruction may be 
complicated by mucus hypersecretion, airway wall edema and changes in the 
mechanical properties of the airways, and research in these areas is in the 
early stages of development.  Finally, a plethora of recent discoveries 
concerning the role of immune mechanisms in asthma and allergic diseases have 
originated in animal models or in vitro systems.  These must be confirmed in 
human studies, which will require a coordinated multidisciplinary effort 
involving basic scientists and clinical researchers.  Recent advances in 
technology, ranging from genomic and proteomic tools to high-resolution 
imaging, are available to support such studies.  Innovative research in these 
important areas is essential to further elucidate the molecular and cellular 
immune mechanisms involved in the pathogenesis of asthma and allergic diseases 
and will lead to the development of the next generation of therapeutic agents 
and prevention strategies.

Research Objectives and Scope

The purpose of the AADRC program is to accelerate the development and 
application of fundamental knowledge of the immune system to investigations of 
asthma and allergic diseases.  The AADRCs provide an infrastructure and a 
collaborative environment that make it possible to investigate complex 
clinical problems.  The major goals of the program are to: 1) advance 
understanding of the etiology and pathogenic mechanisms of asthma and allergic 
diseases, and 2) apply an expanded knowledge base to the development of 
improved methods of diagnosis, treatment, and prevention of asthma and 
allergic diseases.

Examples of research areas to be supported under this RFA include, but are not 
limited to:  

o   the natural history of asthma and allergic diseases, including the 
identification of genetic and environmental risk factors for the development 
of these diseases; 

o   studies of pre- and postnatal alterations in immune function that 
contribute to the onset or progression of asthma and allergic diseases; 

o   studies of cellular and molecular mechanisms that contribute to airway 
inflammation and acute airway obstruction and their role in the 
pathophysiology of asthma; 

o   identification of asthma phenotypes and the characterization of asthma 
expression in relation to underlying mechanisms that distinguish distinct 
subsets of asthma patients; 

o   the role of the innate immune system in the pathogenesis of asthma and 
allergic diseases;
 
o   characterization of the pulmonary and systemic immune response to 
aeroallergens, including mechanisms that result in immune tolerance; 

o   cellular and molecular mechanisms involved in food allergy and other 
severe allergic reactions, with an emphasis on novel therapeutic or prevention 
strategies such as DNA vaccines; 

o   translational research, from animal models or in vitro systems to humans, 
particularly focused on new immune therapies for asthma and allergic diseases, 
including proof of concept studies in humans.  

Autoimmunity, immune deficiency, and Demonstration and Education Research 
Projects are not within the scope of this RFA.

MECHANISM OF SUPPORT

This RFA will use the NIH program project (P01) award mechanism. As an 
applicant you will be solely responsible for planning, directing, and 
executing the proposed project. This type of award supports broadly based 
multidisciplinary research programs that have a well-defined central research 
focus or objective.  An important feature is that the interrelationships among 
the individual scientifically meritorious projects will result in a greater 
contribution to the overall program goals than if each project was pursued 
individually.  The program project grant consists of a minimum of three 
interrelated individual research projects that contribute to the program 
objective.  The award also can provide support for certain common resources 
termed cores.  Such resources should be utilized by two or more projects 
within the award.

Applications may include investigators from more than one institution, if that 
enhances the scientific strength of the application.  In addition, applicants 
are strongly encouraged to include one or more investigators who are not 
currently involved in studies of asthma and allergic diseases.

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.

FUNDS AVAILABLE
 
The NIAID intends to commit approximately $4.8 million in FY 2003 to fund 
approximately 4 new and/or competitive continuation grants in response to this 
RFA. An applicant may request a project period of up to 5 years and a budget 
for total costs (direct and facility and administrative) of up to $1.2 million 
per year.  Under exceptional circumstances applicants may propose budgets that 
exceed this amount, but will require prior approval of the project officer.  
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 NIAID 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 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  

Foreign organizations are not eligible to apply.

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

The goal of this RFA is to support multidisciplinary research programs focused 
on studies of immunologic and other mechanisms underlying human asthma and 
allergic diseases. The AADRCs provide an infrastructure and a collaborative 
environment that make it possible to investigate complex clinical problems. 
Applications must propose a minimum of three research projects organized 
around a central scientific theme.  The application should include an 
appropriate balance of basic and clinical research but with a significant 
emphasis on human studies.  Among the projects recommended for funding: 

o A minimum of one project must focus on immunologic aspects of asthma and/or 
allergic diseases in humans, including advancing our understanding of the 
etiology and pathogenic mechanisms of asthma and allergic diseases and/or 
applying the expanded knowledge base to the development of improved methods of 
diagnosis, treatment, and prevention.  This project may involve clinical 
studies of patients with asthma and/or other allergic diseases or in vitro 
investigations of patients' blood, fluid and/or tissue samples, immune cells 
and DNA/RNA. 

o Studies of relevant animal models may be included in the other research 
projects.

When clinical studies or trials are a component of the research proposed, 
NIAID policy requires that studies be monitored commensurate with the degree 
of potential risk to study subjects and the complexity of the study.  Terms 
and Conditions of Award will be included with awards.  NIAID policy was 
announced in the NIH Guide on February 24, 2000 and is available at: 
http://grants.nih.gov/grants/guide/notice-files/NOT-AI-00-003.html.  The full 
policy including terms and conditions of award are available at: 
http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf.

WHERE TO SEND INQUIRIES

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:

Direct your questions about scientific/research issues to:

Ken Adams, Ph.D. 
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases  
Room 5147, MSC-7640
6700-B Rockledge Drive
Bethesda, MD  20892-7640
Telephone:  (301) 402-8179
FAX:        (301) 402-0175
E-Mail:     [email protected]
  
Direct your questions about peer review issues; address the letter of intent; 
mail two copies of the application and all five sets of appendices to:
  
Edward W. Schroder, Ph.D.  
Division of Extramural Activities  
National Institute of Allergy and Infectious Diseases  
Room 2156, MSC-7616
6700-B Rockledge Drive  
Bethesda, MD  20892-7616
Telephone:  (301) 435-8537
FAX:        (301) 402-2638
E-Mail:    [email protected]

Direct your questions about financial or grants management matters to:

Jaqueline Johnson 
Division of Extramural Activities  
National Institute of Allergy and Infectious Diseases  
Room 2127, MSC-7614
6700-B Rockledge Drive  
Bethesda, MD  20892-7614  
Telephone:  (301) 402-5936
Fax:        (301) 480-3780
E-mail:    [email protected] 
 
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 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 to:

Edward W. Schroder, Ph.D.  
Division of Extramural Activities  
National Institute of Allergy and Infectious Diseases  
Room 2156, MSC-7616
6700-B Rockledge Drive  
Bethesda, MD  20892-7616
Telephone:  (301) 435-8537
FAX:        (301) 402-2638
E-Mail:    [email protected]

SUBMITTING AN APPLICATION

APPLICANTS FOR P01 GRANTS MUST FOLLOW SPECIAL APPLICATION GUIDELINES IN THE 
NIAID BROCHURE ENTITLED INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT 
AWARDS; THIS BROCHURE IS AVAILABLE VIA THE WWW AT: 
http://www.niaid.nih.gov/ncn/grants/multibron.htm

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) 710-0267, 
Email: [email protected].
 
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 exact copies of the grant 
application and all five sets of any appendix material must be sent to:

Edward W. Schroder, Ph.D.  
Division of Extramural Activities  
National Institute of Allergy and Infectious Diseases  
Room 2156, MSC-7616
6700-B Rockledge Drive  
Bethesda, MD  20892-7616
BETHESDA, MD  20817 (for express mail or courier service)

Applications must be received by November 13, 2002. Applications that are not 
received as a single package on the receipt date or that do not conform to the 
instructions contained in PHS 398 (rev. 5/01) Application Kit (as modified in, 
and superseded by, the NIAID BROCHURE ENTITLED "INSTRUCTIONS FOR APPLICATIONS 
FOR MULTI-PROJECT AWARDS"), will be judged non-responsive and will be returned 
to the applicant.  

It is highly recommended that the appropriate NIAID program contact be 
consulted before submitting the letter of intent and during the early stages 
of preparation of the application.  (See program contact under INQUIRIES).

SPECIAL INSTRUCTIONS FOR COMPLETION OF APPLICATIONS IN RESPONSE TO THIS RFA:  

APPLICANTS FOR P01 GRANTS MUST FOLLOW SPECIAL APPLICATION GUIDELINES IN THE 
NIAID BROCHURE ENTITLED INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT 
AWARDS; THIS BROCHURE IS AVAILABLE VIA THE WWW AT: 
http://www.niaid.nih.gov/ncn/grants/multibron.htm

The brochure presents specific instructions for sections of the PHS 398 (rev. 
5/01) application form that should be completed differently than usual.  For 
all other items in the application, follow the usual instructions in the PHS 
398.

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.

Concurrent submission of an R01 and a Component Project of a Multi-project 
Application:  Current NIH policy permits a component research project of a 
multi-project grant application to be concurrently submitted as a traditional 
individual research project (R01) application.  If, following review, both the 
multi-project application and the R01 application are found to be in the 
fundable range, the investigator must relinquish the R01 and will not have the 
option to withdraw from the multi-project grant.  This is an NIH policy 
intended to preserve the scientific integrity of a multi-project grant, which 
may be seriously compromised if a strong component project(s) is removed from 
the program.  Investigators wishing to participate in a multi-project grant 
must be aware of this policy before making a commitment to the Principal 
Investigator and awarding institution.

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NIAID. 

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 NIAID 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 selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a second level review by the National Institute of Allergy and 
Infectious Diseases Council

REVIEW CRITERIA

The general review criteria for P01 grant applications are presented in the 
NIAID brochure entitled "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT 
AWARDS" at http://www.niaid.nih.gov/ncn/grants/multibron.htm
 
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:      October 11, 2002
Application Receipt Date:           November 13, 2002
Scientific Peer Review Date:        March 15, 2003
Advisory Council Review:            June 2, 2003
Earliest Anticipated Start Date:    September 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_2001.htm. 
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable; and 
b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
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 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.

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 Catalogue of Federal Domestic Assistance in 
the following citations: No. 93.855, Immunology, Allergy, and Transplantation 
Research and No. 93.856, Microbiology and Infectious Diseases Research. 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 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 NIH Grants Policy Statement is available at 
http://grants.nih.gov/grants/policy/policy.htm.  This document includes 
general information about the grant application and review process; 
information on the terms and conditions that apply to NIH Grants and 
cooperative agreements; and a listing of pertinent offices and officials at 
the NIH.

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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