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/archive/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

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) 435-0714, 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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