CAUSES AND MECHANISMS OF COPD EXACERBATIONS
 
RELEASE DATE:  September 16, 2004
 
RFA Number:  RFA-HL-04-036

EXPIRATION DATE:  January 12, 2005

Department of Health and Human Services (DHHS)
 
PARTICIPATING ORGANIZATION: 
National Institutes of Health (NIH)
  (http://www.nih.gov) 

COMPONENT OF PARTICIPATING ORGANIZATION:
National Heart, Lung, and Blood Institute (NHLBI) 
  (http://www.nhlbi.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER
No. 93.838, Lung Diseases Research
 
LETTER OF INTENT RECEIPT DATE:  December 13, 2004
APPLICATION RECEIPT DATE:  January 11, 2005
 
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 Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA 

The NHLBI invites applications for research projects that will 
investigate the causes of and molecular pathways involved in acute 
exacerbations of chronic obstructive pulmonary disease (COPD).  
Clinical and basic research supported through this program must seek 
new knowledge that may lead to the development of more effective 
approaches to the prevention and treatment of exacerbations in COPD.  
While the studies may be descriptive in part, all research projects 
supported through this RFA must include hypothesis-based, mechanistic 
investigations that lead toward the identification of molecular targets 
for therapeutic intervention.
 
RESEARCH OBJECTIVES

Moderate-to-severe COPD is characterized by periods of profound 
worsening of respiratory symptoms that may occur up to several times 
per year.  Most exacerbations are idiopathic, though some are due to 
viral or bacterial infections.  Some exacerbations are mild and may not 
be reported by the patient, but others produce striking clinical 
deterioration and require hospitalization.  While recovery is 
essentially complete in most cases, treatment failures account for many 
of the 120,000 COPD deaths in this country each year.  Approximately 
$10 billion per year, or nearly two thirds of the total direct costs of 
medical care in the U.S. related to COPD, is expended for the treatment 
of exacerbations.  Despite this, medical interventions appear to have 
only a modest effect on the intensity, duration, and mortality of COPD 
exacerbations.  Hence, new approaches for preventing and treating 
exacerbations are urgently needed to increase the quality and length of 
life for COPD patients and possibly reduce the overall cost of their 
care.

Little is known about what causes COPD exacerbations, what individual 
factors determine risk or susceptibility, what cellular and molecular 
mechanisms are involved, what mechanisms contribute to remission, or 
how exacerbations may hasten the progressive loss of pulmonary function 
seen in COPD.  Better understanding of why exacerbations develop and 
what pathways mediate their manifestations is needed to identify 
targets for prevention strategies and more effective therapies.  This 
initiative will support a variety of studies related to the causes of 
and pathways contributing to exacerbations of COPD.  All research 
projects supported through this RFA will include mechanistic studies of 
molecular hypotheses.  By improving understanding of the molecular 
events involved in the initiation, development, and resolution of 
exacerbations, these studies will aid in identifying specific targets 
for more effective preventive and therapeutic interventions. 

Anticipated approaches include development of novel methods for 
detection and grading of exacerbations; clinical investigations of 
instigating factors, manifestations, outcomes, and effects of 
treatments; correlation of microbiological and biomarker measures with 
clinical course; characterization of inflammatory cells and mediators; 
assessments of host defense mechanisms before, during, and after an 
exacerbation; testing of genotype associations; and in vitro and animal 
studies of the molecular pathways involved.  Research goals that are 
relevant to this solicitation include, but are not limited to, the 
following:

o Evaluate methods for detection and measurement of exacerbations; 
possibly involving pulmonary mechanics, microphonic monitoring of cough 
frequency, biomarkers in exhaled breath, and patient scoring of dyspnea 
and sputum volume and color.

o Identify predisposing factors (e.g., immune dysfunction, comorbidity, 
airway bacterial colonization) and triggers (e.g., upper respiratory 
tract infection, exposure to airborne pollutants or allergens, improper 
use of medications, or stress) of exacerbations.

o Study molecular pathways through which airway inflammation produces 
worsening of respiratory symptoms during an exacerbation.

o Examine the involvement of specific molecules and pathways in the 
onset, perpetuation, and remission of exacerbations.

o Perform genomic and proteomic surveys of molecular events that occur 
in airways during the course of an exacerbation.

o Conduct genetic association studies of susceptibility to frequent 
exacerbations.

o Test the contributions of specific viral proteins, bacterial 
products, inflammatory cells and cytokines, proteases, mediators of 
mucous secretions, endogenous bronchoconstrictors (e.g., endothelin-1), 
or systemic mediators (e.g., tumor necrosis factor ?, fibrinogen) to 
the progression and clinical manifestations of exacerbations.

o Carry out animal studies of the regulation and pathophysiological 
effects of molecular pathways that are activated during a COPD 
exacerbation.

MECHANISM OF SUPPORT
 
This RFA will use the NIH 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 September 30, 2005.  Applications that are 
not funded in the competition described in this RFA may be resubmitted 
as NEW investigator-initiated applications using the standard receipt 
dates for NEW applications described in the instructions to the PHS 398 
application. 

This RFA uses just-in-time concepts.  It also uses the modular 
budgeting 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 budget format.  
Otherwise follow the instructions for non-modular budget research grant 
applications.  This program does not require cost sharing as defined in 
the current NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm.

FUNDS AVAILABLE
 
The NHLBI intends to commit approximately $2,500,000 in FY 2005 to fund 
5 to 7 new grants in response to this RFA. An applicant may request a 
project period of up to 5 years and a budget for direct costs of up to 
$275,000 in the first year, $500,000 in years 02-04, and $275,000 in 
the fifth 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.  Applications 
requesting 5 years of support must provide a specific justification for 
that project duration.  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.  
 
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 institutions/organizations
o Foreign institutions that offer unusual talent, resources, 
populations, or environmental conditions that are not readily available 
in the United States or that augment existing U.S. resources.
o Faith-based or community-based organizations
 
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

Applicants must propose an operational definition of COPD exacerbations 
and a system for grading the severity of exacerbations.  The NHLBI will 
coordinate discussions among investigators and convene a meeting during 
the first year of the program to encourage the development of a 
consensus definition and grading system for use in all clinical studies 
of this program.

The proposed research plan may include the validation of methods for 
detecting and grading COPD exacerbations and descriptive studies that 
seek to demonstrate associations between exacerbations and predisposing 
or aggravating factors.  However, the research projects supported 
through this solicitation may not be entirely methodological and 
descriptive in nature.  All applications must include studies that are 
based on stated hypotheses that involve particular molecular pathways 
or events.

All studies must be relevant to COPD exacerbations in humans.  The new 
knowledge to be gained must serve to enable the development of better 
approaches for the prevention and/or clinical management of COPD 
exacerbations.  Studies of animal models or in vitro systems will be 
allowed only if their relevance to human COPD exacerbations is 
established.  

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:

o Direct your questions about scientific/research issues to:

Tom Croxton, Ph.D., M.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
Rockledge II, Room 10208
6701 Rockledge Drive
Bethesda, MD  20892-7952
Telephone:  (301) 435-0202
FAX:  (301) 480-3557
Email:  croxtont@nhlbi.nih.gov

o Direct your questions about peer review issues to:

Valerie Prenger, Ph.D.
Chief Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Rockledge II, Room 7194
6701 Rockledge Drive
Bethesda, MD  20892-7924
Telephone:  (301) 435-0288
FAX:  (301) 480-4755
Email:  prengerv@nhlbi.nih.gov

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

Mr. John Diggs
Grants Management Specialist
Grants Operations Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Rockledge II, Room 7155
6701 Rockledge Drive
Bethesda, MD  20892-7926
Telephone:  (301) 435-0159
FAX:  (301) 480-0422
Email:  diggsj@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:

Valerie Prenger, Ph.D.
Chief Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Rockledge II, Room 7194
6701 Rockledge Drive
Bethesda, MD  20892-7924
Telephone:  (301) 435-0288
FAX:  (301) 480-4755
Email:  prengerv@nhlbi.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001). Applications must 
have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) 
number as the Universal Identifier when applying for Federal grants or 
cooperative agreements. The DUNS number can be obtained by calling 
(866) 705-5711 or through the web site at 
http://www.dunandbradstreet.com/. The DUNS number should be entered on 
line 11 of the face page of the PHS 398 form. The PHS 398 document is 
available at 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.
 
SUPPLEMENTARY INSTRUCTIONS:
 
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/labels.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 and 
all copies of the appendix material must be sent to:
 
Valerie Prenger, Ph.D.
Chief Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Rockledge II, Room 7194
6701 Rockledge Drive
Bethesda, MD  20892-7924
 
APPLICATION PROCESSING: Applications must be received on or before the 
application receipt date listed in the heading of this RFA.  If an 
application is received after that date, it will be returned to the 
applicant without review. 

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and 
funding assignment within 8 weeks.
 
The Center for Scientific Review (CSR) will not accept any application 
in response to this RFA that is essentially the same as one currently 
pending initial review, unless the applicant withdraws the pending 
application.  However, when a previously unfunded application, 
originally submitted as an investigator-initiated application, is to be 
submitted in response to an RFA, it is to be prepared as a NEW 
application.  That is, the application for the RFA must not include an 
Introduction describing the changes and improvements made, and the text 
must not be marked to indicate the changes from the previous unfunded 
version of the application.

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the NHLBI. Incomplete applications will not be 
reviewed.  If the application is not responsive to the RFA, NIH staff 
may contact the applicant to determine whether to return the 
application to the applicant or submit it for review in competition 
with unsolicited applications at the next appropriate NIH review cycle.

Applications that are complete and responsive to the RFA will be 
evaluated for scientific and technical merit by an appropriate peer 
review group convened by the NHLBI in accordance with the review 
criteria stated below.  As part of the initial merit review, all 
applications will:

o Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications 
under review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the National Heart, Lung, and Blood 
Advisory 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 evaluate the 
application in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals. The 
scientific review group will address and consider each of the following 
criteria in assigning the application’s overall score, weighting them 
as appropriate for each application. 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The 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, an investigator may propose to carry out 
important work that by its nature is not innovative but is essential to 
move a field forward.

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

APPROACH: Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of 
the project? Does the applicant acknowledge potential problem areas and 
consider alternative tactics?

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

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

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

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the 
following items will be considered in the determination of scientific 
merit and the priority score:

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of 
human subjects and protections from research risk relating to their 
participation in the proposed research will be assessed. (See criteria 
included in the section on Federal Citations, below).
 
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 in the 
sections on Federal Citations, below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals 
are to be used in the project, the five items described under Section f 
of the PHS 398 research grant application instructions (rev. 5/2001) 
will be assessed. 
 
ADDITIONAL REVIEW CONSIDERATIONS

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:  December 13, 2004
Application Receipt Date:  January 11, 2005
Peer Review Date:  May-June 2005
Council Review:  September 1, 2005
Earliest Anticipated Start Date:  September 30, 2005

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 

HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated 
with reference to the risks to the subjects, the adequacy of protection 
against these risks, the potential benefits of the research to the 
subjects and others, and the importance of the knowledge gained or to 
be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

DATA AND SAFETY MONITORING PLAN:  Data and safety monitoring is 
required for all types of clinical trials, including physiologic, 
toxicity, and dose-finding studies (phase I); efficacy studies (phase 
II); efficacy, effectiveness and comparative trials (phase III).  The 
establishment of data and safety monitoring boards (DSMBs) is required 
for multi-site clinical trials involving interventions that entail 
potential risk to the participants.  (NIH Policy for Data and Safety 
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 "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.  Because COPD is a disease of 
adults, it is anticipated that studies supported through this program 
will not include children as research participants.  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://stemcells.nih.gov/index.asp 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, in the project description and elsewhere in the application as 
appropriate, the official NIH identifier(s) for the hESC line(s)to be 
used in the proposed research.  Applications that do not provide this 
information will be returned without review. 

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.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  
The Department of Health and Human Services (DHHS) issued final 
modification to the “Standards for Privacy of Individually Identifiable 
Health Information”, the “Privacy Rule,” on August 14, 2002.  The 
Privacy Rule is a federal regulation under the Health Insurance 
Portability and Accountability Act (HIPAA) of 1996 that governs the 
protection of individually identifiable health information, and is 
administered and enforced by the DHHS Office for Civil Rights (OCR).  

Decisions about applicability and implementation of the Privacy Rule 
reside with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, 
including a complete Regulation Text and a set of decision tools on “Am 
I a covered entity?”  Information on the impact of the HIPAA Privacy 
Rule on NIH processes involving the review, funding, and progress 
monitoring of grants, cooperative agreements, and research contracts 
can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.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.  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.healthypeople.gov/.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject 
to the intergovernmental review requirements of Executive Order 12372 
or Health Systems Agency review.  Awards are made under the 
authorization of Sections 301 and 405 of the Public Health Service Act 
as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 
and 45 CFR Parts 74 and 92.  All awards are subject to the terms and 
conditions, cost principles, and other considerations described in the 
NIH Grants Policy Statement.  The NIH Grants Policy Statement can be 
found at http://grants.nih.gov/grants/policy/policy.htm.

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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