ASTHMA EXACERBATIONS: BIOLOGY AND DISEASE PROGRESSION
RELEASE DATE: February 27, 2004
RFA Number: RFA-HL-04-029
EXPIRATION DATE: June 19, 2004
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)
National Institute of Allergy and Infectious Diseases (NIAID)
(http://www.niaid.nih.gov
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S)
No. 93.838, Lung Diseases Research
No. 93.855, Immunology, Allergy and Transplantation Research
No. 93.856, Microbiology and Infectious Diseases Research
LETTER OF INTENT RECEIPT DATE: May 18, 2004
APPLICATION RECEIPT DATE: June 18, 2004
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
Asthma exacerbations are a major cause of morbidity and mortality in
asthma and a significant concern for the clinical management of the
disease. The National Heart, Lung and Blood Institute (NHLBI) and the
National Institute of Allergy and Infectious Diseases (NIAID) invite
applications, in clinical and basic research, that will elucidate the
biologic mechanisms of asthma exacerbation pathobiology and resolution
and their impact on lung function, physiology and disease state.
RESEARCH OBJECTIVES
Background
Over the past two decades, the prevalence of asthma in the United
States has more than doubled with over 14 million people now afflicted
with this disease. Asthma exacerbations are a major cause of lost days
from work and school, sleep disruption, restricted activities,
physician and emergency room visits and asthma-related mortality.
Additionally, management of disease exacerbations consumes a large
proportion of the estimated annual 20 billion dollars that asthma costs
the U.S. economy. Currently, we have little understanding of the
pathophysiologic processes that occur during an exacerbation, how
exacerbations resolve, the impact of exacerbations on future
exacerbation severity and frequency, and what the long term impact of
exacerbations is on lung physiology, function and disease progression.
This information is critical for the development of more effective
treatment modalities that will control symptoms and exacerbations while
maintaining or improving lung function.
In contrast to our understanding of the basic underlying inflammatory
mechanisms of asthma pathogenesis, the mechanisms and consequences of
exacerbations have not been well-studied and are poorly understood.
The potential relationship between exacerbations and progressive loss
of lung function needs to be explored and defined. Since exacerbations
often occur while the patient is receiving treatment, it is likely that
the mechanisms of these reactions are distinct from the processes in
more stable disease. Many patients with asthma experience
exacerbations which seem to resolve completely with periods of normal
lung function in between each exacerbation. However, it is unclear
whether changes in lung structure, function and immune response remain
following exacerbations, setting the stage for future episodes,
ultimately contributing to disease chronicity and persistence.
Knowledge regarding resolution of exacerbations is particularly
lacking.
Research is needed which will define the pathways by which the immune
response and subsequent inflammation are altered during resolution.
Limited knowledge exists regarding: the initial signals that down
regulate inflammation; regulatory cells, mediators and the mechanisms
that effect down regulation; characterization of crosstalk between
pathways responsible for immune response activation and termination;
and termination of mechanisms which result in altered lung physiology
and function such as mucus metaplasia, airway smooth muscle
hypertrophy, damage to the bronchial epithelium, sub-epithelial
collagen deposition and altered immune responsiveness.
While current asthma treatments are effective at controlling initial
inflammation, accumulating evidence suggests that certain aspects of
the disease process are ongoing despite therapy. Additionally, there
is an increasing awareness of subsets of asthma patients whose disease
is not well-controlled with the use of currently available treatments.
Elucidation of the mechanisms of the pathophysiology and resolution of
exacerbations will provide the basis for development of interventions
which will be able to target ongoing, downstream processes that result
in altered immune response and airways physiology and function.
Research Scope
The objective of this RFA is to explore the underlying pathobiology and
mechanisms of resolution of exacerbations; how these processes impact
lung function and physiology during and after the exacerbation; and the
relation of exacerbations to future frequency and severity of
exacerbation and disease progression. Applicants are expected to
define their exacerbation model and discuss the implications of the
initiating trigger and how it relates to pathophysiology of
exacerbation, if relevant. Studies may be conducted in either humans
or animals; however, studies in human subjects are strongly encouraged.
Basic studies must be able to relate proposed research directly to the
questions posed above, in a relevant model. Programs that combine
basic and clinical studies are desired. Intervention-based clinical
trials and long-term epidemiology studies and studies focusing on
exacerbation triggers are not appropriate for this RFA.
Some examples of research areas appropriate for this RFA include, but
are not limited to the following:
o Identification of immune regulatory and effector cells and
molecules which control inflammation during the active and
resolution phases of exacerbations.
o Characterization of interactions among immune cells, mediators
and lung cells responsible for immune response activation and
termination.
o Characterization of the role of the innate immune system and
interactions between innate and adaptive immune mechanisms during
exacerbations.
o Characterization of the role of apoptosis in termination of the
pulmonary immune response during exacerbation resolution.
o Delineation of alterations in lung function, airway structure and
cellular composition, and neural control during exacerbation and
resolution.
o Characterization of genetic factors associated with frequency
and/or severity of exacerbation.
o Utilization of state-of-the-art imaging techniques to gain
knowledge regarding effector pathways and cells involved in
exacerbation and resolution and assessment of airway physiology
and function during the active and resolution phases of
exacerbation.
o Assessment of lung structure, function and pulmonary immune
responsiveness between exacerbations and the relationship between
these parameters and future exacerbation frequency and severity.
o Characterization of experimental interventional models (e.g.
immunization, vaccination) for the protection of exacerbations.
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 April 1, 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 format. (see
http://grants.nih.gov/grants/funding/modular/modular.htm). This
program does not require cost sharing as defined in the current NIH
Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm
FUNDS AVAILABLE
The NHLBI and the NIAID intend to commit approximately $5.7 million in
FY 04 to fund 8 to 12 new and/or competitive continuation grants in
response to this RFA. An applicant may request a project period of up
to 4 years and a budget for direct costs of up to $350,000 per year.
Since the total costs for a subcontract or consortium are included in
the direct cost request, one additional module of $25,000 above the cap
may be requested for the facilities and administrative costs associated
with third party agreements. A module requested for this purpose must
be clearly identified in the budget justification section of the
application, and will be restricted for this purpose only at the time
of award. 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 and 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.
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 institutions/organizations
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
The intent of this program is to fund clinical and basic research
related to the pathobiology of asthma exacerbations. Research
involving human subjects is strongly encouraged. Programs that combine
basic and clinical studies are desired. Studies that confine
themselves to basic research must be able to relate proposed research
directly to the questions posed above, in a relevant model.
Intervention-based clinical trials and long-term epidemiology studies
and studies focusing on exacerbation triggers are not appropriate for
this RFA.
Applicants are expected to include sufficient travel funds for one RFA
meeting per year to be held in Bethesda, MD. At these meetings,
Principal Investigators are expected to share data and ideas with other
participants in order to facilitate sharing of knowledge and
collaboration in this specific area.
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:
Patricia Noel, Ph.D.
Division of Lung Diseases
National Heart, Lung and Blood Institute
Rockledge II, Room 10222
Bethesda, MD 20892
Telephone: (301) 435-0202
FAX: (301) 480-3557
Email: noelp@nih.gov
Or
Hector Ortega, M.D., Sc.D.
Division of Lung Diseases
National Heart, Lung and Blood Institue,
Rockledge II, Room 10218
Bethesda, MD 20892
Telephone: (301) 435-0202
FAX: 301-480-3557
Email: ortegah@nhlbi.nih.gov
Or
Ken Adams, Ph.D.
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
Room3103, MSC-6601
6610 Rockledge Drive
Bethesda, MD 20892-6601
Telephone: (301) 496-8973
FAX: (301) 402-0175
Email: kadams@niaid.nih.gov
o Direct your questions about peer review issues to:
Anne P. Clark, Ph.D.
Chief Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214, MSC 7924
Bethesda, MD 20892-7924
Bethesda, MD 20817 (for express/courier service)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email:clarka@nhlbi.nih.gov
o Direct your questions about financial or grants management matters
to:
Mr. Ephraim Johnson
Grants Management Specialist
Grants Operation Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7150
Bethesda, MD 20892-7926
Phone: (301) 594-9529
FAX: (301) 480-3310
Email: Johnsone@nhlbi.nih.gov
Or
Ken Adams, Ph.D.
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
Room3103, MSC-6601
6610 Rockledge Drive
Bethesda, MD 20892-6601
Telephone: (301) 496-8973
FAX: (301) 402-0175
Email: kadams@niaid.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 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 to Dr. Anne Clark at the address listed under the
WHERE TO SEND INQUIRES.
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) 710-0267, Email: GrantsInfo@nih.gov.
SUPPLEMENTARY INSTRUCTIONS:
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications 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. For this announcement the
modular ceiling has been increased to $350,000 direct costs. 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 Dr. Anne Clark at
the address listed under WHERE TO SEND INQUIRES.
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 and/or nonresponsive
applications will not be reviewed.
Not appropriate; budget limits, unusual use of modular.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 NHLBI or the NIAID National
Advisory Council or Board.
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: May 18, 2004
Application Receipt Date: June 18, 2004
Peer Review Date: October 2004
Council Review: February 10, 2005
Earliest Anticipated Start Date: April 1, 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: (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. 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://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).
Those who must comply with the Privacy Rule (classified under the Rule
as covered entities ) must do so by April 14, 2003 (with the exception
of small health plans which have an extra year to comply).
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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