PILOT CLINICAL TRIALS IN THE EPIDEMIOLOGY, PREVENTION AND TREATMENT OF 
RESPIRATORY FAILURE IN CHILDREN
 
RELEASE DATE:  July 26, 2002
 
RFA:  HD-02-027
 
National Institute of Child Health and Human Development (NICHD) 
 (http://www.nichd.nih.gov/)
 
National Institute of Nursing Research (NINR) 
 (http://www.ninr.nih.gov)

LETTER OF INTENT RECEIPT DATE:  October 31, 2002

APPLICATION RECEIPT DATE:  November 26, 2002

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA 

The National Institute of Child Health and Human Development (NICHD) and the 
National Institute of Nursing Research (NINR) solicit applications for 
clinical studies designed to enhance understanding and prevention and 
treatment of respiratory failure in children.  The present clinical 
literature documents the efficacy of various treatment modalities, including 
mechanical ventilation strategies employing conventional and innovative 
techniques, over a wide range of parameters, manipulated with both invasive 
and non-invasive maneuvers.  Survival of children mechanically ventilated for 
a wide variety of indications is now the rule.  

This RFA solicits clinical studies to 1) define and characterize acute and 
chronic respiratory failure of various etiologies in children, 2) develop new 
approaches to prevent the development of chronic functional disability in 
children who have been mechanically ventilated for any cause, and 3) 
ameliorate the effects of mechanical ventilation on child development 
(cognitive and interpersonal), cardiovascular stability, pulmonary function,   
and integration into school and home care.

A separate RFA solicits basic and clinical research specifically addressing 
the problem of improving outcomes after childhood cardiopulmonary arrest, 
specifically, the effects of choice, timing and duration and intensity of 
therapies on functional outcomes. 

RESEARCH OBJECTIVES

Background

The ARDSnet trial, in adults, and other smaller, more descriptive studies in 
children, have underscored with empiric data the importance of carefully 
chosen mechanical ventilation strategies in order to minimize, prevent, and 
control the devastating complications that result from acute respiratory 
failure. However, innovative  ventilatory modalities (equipment and 
strategies), are evolving rapidly.  As more children survive mechanical 
ventilation in the pediatric intensive care unit, data that evaluate the 
incidence of long-term complications are needed. Whether the incidence of 
such complications is related to mechanical ventilatory (equipment and 
strategy) modalities remains unknown.  Long term oxygen and diuretic 
dependence, sleep hypoventilation, the need for persistent tracheostomy, and  
the emerging use of less invasive technologies have not been linked to child 
health  outcomes in the literature in sufficiently powered studies. 

Similarly, children with special needs and complex medical disorders 
represent an increasing proportion of the pediatric critical care patient 
population. Special needs children may need pediatric surgical intervention 
to correct congenital anomalies, or ameliorate the course of disabilities 
that are traumatically sustained.  The effects of such intervention on child 
health parameters remain understudied. This contributes to the increase in 
the number of children with suboptimal respiratory function at the time of 
discharge from the critical care unit, and into the  chronic care and 
outpatient setting.

Acute and chronic ventilatory modalities (strategies and equipment) that 
produce optimal outcomes for special needs children are reported only 
anecdotally in the literature.   Exercise tolerance, vital capacity, chronic 
fibrotic or reactive airway disease, as sequelae of mechanical ventilation 
outside the neonatal age group remain understudied.  To achieve and maintain  
independence from invasive mechanical ventilation, patients and their 
caregivers (physicians,  nurses, respiratory therapists) must walk a tight 
rope, balancing reduction of support against the danger of hypoxia. 
 
Another facet of this balance is evident when the effect of increased 
respiratory work is considered in the disabled child,  however, these 
considerations also apply to children who were physically and functionally 
normal before critical illness, but are left with decreased pulmonary 
reserve. Integration into educational programs, and the ability to live in 
the family unit must be balanced with the need to provide oxygenation and 
mechanical support which will optimize growth and development, cognition, 
emotional health, normal sleep patterns. Indeed, for many children with 
respiratory compromise and their families, the need for prolonged ventilatory 
support is the major obstacle to maximizing child health outcomes in this 
setting. 

The potential of failure of mechanical ventilation and oxygenation systems is 
frightening to children, their families, and schools.   In fact, for some 
children and families, fear of abrupt respiratory failure may outweigh 
motivation to maximize developmental outcome.  Children are then deprived of 
their full potential for development, maturation and successful integration 
into adult society. 
  
Fear of hypoxia and ventilatory failure is well founded, as both confer 
significant morbidity and mortality acutely. Acutely, diminished brain 
function during a hypoxemic episode poses potential dangers to children with 
already diminished functional abilities and reserves. In addition, recurrent 
hypoxemia may impose long-lasting damaging effects on the brain, resulting in 
impairment of memory or other cognitive functions. This is especially a 
concern in the early childhood years when the nervous system is still 
developing, and children are adapting to their disability. 

Recurrent hypoxemia and hypercarbia may eventually also impair the body"s 
defense mechanisms against hypoventilation and hypoxia, creating a vicious 
cycle for the patient. The progressive decline in effective physiologic 
responses to hypoventilation and hypoxia may precipitate or substantially 
worsen chronic disability. Young children cannot reliably report or interpret 
symptoms of hypoxemia and hypoventilation. Chronic use of inhaled beta 
agonists is common in such children and complicates assessment by children 
and their parents and clinicians. Unrecognized decline in respiratory 
sufficiency over time may contribute to catastrophic outcomes in otherwise 
treatable respiratory infections, a too-frequent outcome in special needs 
children.

To address this critical problem for children, the National Center for 
Medical Rehabilitation Research (NCMRR), NICHD, and National Institute of 
Nursing Research (NINR), cosponsored a workshop on mechanical ventilation in 
the disabled, prior to founding the new program in pediatric critical care 
and rehabilitation research.  Most recently, a planning conference of 
subspecialists (May 3-4, 2002) identified the need to study critical care 
interventions and long-term outcomes in children.

Basic research is needed to enhance understanding of the central and 
peripheral control mechanisms that counteract acute and chronic respiratory 
failure, and the pathogenic mechanisms involved in loss of counter-regulatory 
control. In addition, clinical studies are needed to better define the scope 
of the problem and develop new prevention and therapeutic approaches to 
maximize outcomes for childhood survivors of mechanical ventilation.  As a 
first step toward addressing the problem of respiratory failure in children, 
the NICHD has issued this RFA as part of the new program at the NCMRR in 
pediatric critical care and rehabilitation research.  The National Heart, 
Lung, and Blood Institute (NHLBI) has interest in research related to acute 
lung injury and critical care.  Therefore, applications that are of mutual 
interest may be given a secondary assignment to NHLBI in accordance with the 
NIH referral guidelines.

Scope and Objectives

This RFA solicits clinical studies to 1) define the scope and nature of 
respiratory failure in children, especially those with special needs, and 2) 
develop and evaluate acute and chronic  management strategies to prevent or 
minimize the development of chronic respiratory failure in children or to 
ameliorate its effects. Recent scientific and engineering  advances, 
including the availability of innovative approaches and techniques that 
potentially open up new avenues of exploration, might be utilized to enhance 
management and quality of life for children with respiratory failure. 

While this RFA focuses on clinical studies of respiratory failure, basic 
research to evaluate cellular and tissue mechanisms of respiratory 
insufficiency in children is also of interest, particularly as it relates to 
long term adaptation in survival from critical illness in young animals.
 
Appropriate topics for investigation under this RFA would include, but are 
not limited to: 

o Studies to determine the prevalence of respiratory insufficiency in 
children with special needs, with a focus on delineating differences among 
various age groups (e.g., infants, children and adolescents).

o Studies to delineate the role of age, gender, race/ethnicity, socioeconomic 
status and other factors in the risk of respiratory insufficiency, and the 
adaptation to home ventilatory support.

o Studies to identify factors, including acute and chronic modes and 
strategies of ventilatory support, which optimize child health outcomes.

o Studies to establish normative data for respiratory parameters (pulmonary 
function, oxygen saturation levels and indices of ventilation)particularly in 
special needs children requiring ventilatory support, throughout a 24-hour 
period.

o Studies to determine whether there are changes in respiratory regulatory 
mechanisms with age.

o Studies to determine whether novel strategies that minimize the need for 
obtrusive and invasive mechanical ventilatory support  result in more optimal 
short and long-term outcomes in children.

o Studies to assess the reliability and utility of continuous 
oximeters/sensors in detecting hypoxia during sleep, or in situations where 
it may be less apparent in children, particularly those with special needs.

o Studies to determine whether the occurrence of hypoxemia and 
hypoventilation, as well as the need for ongoing ventilatory support, can be 
minimized by altering the choice of drugs, or timing of drug administration, 
or drugs with altered kinetics.

o Studies to determine whether different therapeutic modalities (strategies 
and equipment) regimens for respiratory failure in childhood affect central 
and peripheral regulatory mechanisms.

o Studies to develop and test strategies for minimizing the risk of 
impairment due to subtle alterations in oxygenation and ventilation in 
survivors of critical illness in childhood.
 
MECHANISM OF SUPPORT
 
This RFA will use the NIH Exploratory/Developmental Research Grant (R21) 
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.  The anticipated award date is July 1, 2003. 

The R21 awards are intended to demonstrate feasibility and to obtain 
preliminary data testing innovative ideas that represent clear departure from 
ongoing research interests.  These grants are intended to 1) provide initial 
support for new investigators, 2) allow exploration of possible new 
directions for established investigators, and 3) stimulate investigators from 
other areas to lend their expertise to research within the scope of this 
solicitation.  These R21 grants will not be renewable, continuation of 
projects developed under this program will be through the regular research 
grant (R01) program. 

Applicants from institutions which have a General Clinical Research Center 
(GCRC) funded by the NIH National Center for Research Resources may wish to 
identify the GCRC as a resource for conducting the proposed research.   In 
such a case, a letter of agreement from either the GCRC program director or 
Principal Investigator should be included with the 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).  
Specifically, if you are submitting an application with direct costs in each 
year of $250,000 or less, use the modular format.  

FUNDS AVAILABLE
 
The NICHD and NINR intend to commit approximately $1.15 million in total 
costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2003 to 
fund four to six new grants in response to this RFA.  NINR intends to commit 
funds for one project by a nurse researcher.  An applicant may request a 
project period of up to two years and a budget for direct costs of up to 
$125,000 per year.  Because the nature and scope of the proposed research 
will vary from application to application, it is anticipated that the size 
and duration of each award will also vary.  Although the financial plans of 
the NICHD and NINR 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 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
o Faith-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.   

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:

Carol Nicholson, M.S., M.D.
Program Director, Pediatric Critical Care and Rehabilitation Research
National Institute of Child Health and Human Development 
National Center for Medical Rehabilitation Research
6100 Executive Boulevard, Room 2A03, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301)435-6843
Email:  nicholca@mail.nih.gov

Hilary D. Sigmon Ph.D., R.N.
Program Director
National Institute of Nursing Research
6701 Democracy Boulevard, Room 710, MSC 4870
Bethesda, MD 20892-4870
Telephone:  (301) 480-8260
FAX:  (301) 480-8260
Email:  hilary.sigmon@nih.gov 

o Direct your questions about peer review issues to:

Robert H. Stretch, Ph.D.
Director, Division of Scientific Review 
National Institute of Child Health and Human Development
Building 6100 Room 5B01, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1485 
FAX:  (301) 402-4104
Email:  STRETCH@NIH.GOV

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

Christopher Myers
Grants Management Branch
National Institute of Child Health and Human Development
Building 6100 Room 8A14H, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6996 
FAX:  (301) 480-4783
Email:  cm143g@nih.gov

Tara Mowery
Grants Management Specialist
National Institute of Nursing Research
45 Center Drive MSC 6300
Bethesda, MD 20892-6300
Telephone:  (301) 594-5979
FAX:  (301) 480-8260
Email:  tara-mowery@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 NICHD 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:

Carol Nicholson, M.S., M.D.
Program Director, Pediatric Critical Care and Rehabilitation Research
National Institute of Child Health and Human Development 
6100 Executive Boulevard, Room 2A03, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301)435-6843
Email:  nicholca@mail.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 710-0267, 
Email: GrantsInfo@nih.gov.
 
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS:  Applications 
requesting up to $250,000 per year in direct costs must be submitted in a 
modular grant format.  The modular grant format simplifies the preparation of 
the budget in these applications by limiting the level of budgetary detail.  
Applicants request direct costs in $25,000 modules.  Section C of the 
research grant application instructions for the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular grants.  Additional information on modular 
grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

USING THE RFA LABEL:  The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  Failure to use this label 
could result in delayed processing of the application such that it may not 
reach the review committee in time for review.  In addition, the RFA title 
and number must be typed on line 2 of the face page of the application form 
and the YES box must be marked. The RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
 
SENDING AN APPLICATION TO THE NIH:  Submit a signed, typewritten original of 
the application, including the Checklist, and three signed, photocopies, in 
one package to:
 
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)
 
At the time of submission, two additional copies of the application must be 
sent to:

Robert H. Stretch, Ph.D.
Director, Division of Scientific Review (DSR)
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD  20892-7510
Rockville, MD 20852  (for courier/express service)
 
APPLICATION PROCESSING:  Applications must be received by the application 
receipt date listed in the heading of this RFA.  If an application is 
received after that date, it will be returned to the applicant without 
review.
 
The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  The 
CSR will not accept any application that is essentially the same as one 
already reviewed.  This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must 
include an Introduction addressing the previous critique.

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NICHD and NINR.  Incomplete and/or non-responsive 
applications will be returned to the applicant without further consideration.

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

o Receive a written critique
o Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications under 
review, will be discussed and assigned a priority score
o Receive a second level review by the National Advisory Child Health and 
Human Development Council. 
 
REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to discuss the following 
aspects of your application in order to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of these 
goals: 

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

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

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

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

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

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

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

o PROTECTIONS:  The adequacy of the proposed protection for humans, animals, 
or the environment, to the extent they may be adversely affected by the 
project proposed in the application.

o INCLUSION:  The adequacy of plans to include subjects from both genders, 
all racial and ethnic groups (and subgroups), and children as appropriate for 
the scientific goals of the research.  Plans for the recruitment and 
retention of subjects will also be evaluated. (See Inclusion Criteria 
included in the section on Federal Citations, below)

o BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  October 31, 2002
Application Receipt Date:  November 26, 2002
Peer Review Date:  February/March 2003
Council Review:  June 2003
Earliest Anticipated Start Date:  July 1, 2003

AWARD CRITERIA

Criteria that will be used to make award decisions include:

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
 
REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD:  Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

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

All investigators proposing clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete 
copy of the updated Guidelines is 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.

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

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

URLs IN NIH GRANT APPLICATIONS OR APPENDICES:  All applications and proposals 
for NIH funding must be self-contained within specified page limitations. 
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) 
should not be used to provide information necessary to the review because 
reviewers are under no obligation to view the Internet sites.  Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

HEALTHY PEOPLE 2010:  The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of "Healthy 
People 2010," a PHS-led national activity for setting priority areas.  This 
RFA is related to one or more of the priority areas.  Potential applicants 
may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance No. 93.929 (NICHD) and 93.361 (NINR), and is not 
subject to the intergovernmental review requirements of Executive Order 12372 
or Health Systems Agency review.  Awards are made under authorization of 
Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 
and 284) and administered under NIH grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92.

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

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