INNOVATIVE TECHNOLOGIES FOR PEDIATRIC CRITICAL CARE AND REHABILITATION 
(SBIR/STTR)

RELEASE DATE:  July 29, 2003

RFA NUMBER:  RFA-HD-03-014  

National Institute of Child Health and Human Development (NICHD)       
 (http://www.nichd.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.929

LETTER OF INTENT RECEIPT DATE:  September 15, 2003

APPLICATION RECEIPT DATE:  October 15, 2003

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 Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

NOTICE:  This Request for Application (RFA) must be read in conjunction with 
the current OMNIBUS SOLICITATION OF THE NATIONAL INSTITUTES OF HEALTH, 
CENTERS FOR DISEASE CONTROL AND PREVENTION, and FOOD AND DRUG ADMINISTRATION 
FOR SMALL BUSINESS INNOVATION RESEARCH (SBIR) AND SMALL BUSINESS TECHNOLOGY 
TRANSFER (STTR) GRANT APPLICATIONS.  The solicitation (see 
http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf) contains 
information about the SBIR and STTR programs, regulations governing the 
programs, and instructional information for submission. All of the 
instructions within the SBIR/STTR Omnibus Solicitation apply with the 
following exceptions:

o  Special Receipt Date

PURPOSE OF THIS RFA

This announcement is designed to encourage small businesses to participate in 
research on innovative technology that facilitates the recovery and 
rehabilitation of children from critical illness.  The goals of this program 
are, in the broadest possible context, to enable rapid recovery and 
adaptation of children with and without special needs who have sustained 
critical illness.  This may involve improving or enhancing cardiopulmonary 
function, integrating technologies that support children with long-term 
special needs into chronic care, home, and school settings, as well as the 
development of new devices, technologies, delivery systems, and environmental 
modifications, behavioral interventions, and/or training techniques.  This 
initiative is designed to expedite the transition of innovative technology 
and development into practical applications.

The development of new technologies and the modifications of existing 
technologies may require a multidisciplinary approach.  Therefore, 
investigators responding to this initiative may be drawn from such fields as 
neuroscience, critical care, pulmonology, biology, chemistry, engineering, 
psychology, education, rehabilitation, and health services research.

RESEARCH OBJECTIVES

Background

For the purposes of this RFA, critical illness is defined as any life 
threatening process that compromises the normal growth and development of the 
child, and is not transitory in duration.  Major pediatric critical care 
centers regularly report that large proportions (about half) of the children 
in pediatric intensive care units (PICUs) have special needs and 
disabilities.  Such children are at high risk for conditions that precipitate 
critical illness, such as infection and respiratory failure.  Additionally, 
special needs children are likely to need surgical intervention to correct a 
variety of anatomic and functional defects associated with their condition.  
About 18 percent of the child population is identified as having a chronic 
health condition; using available census data results in an estimate of about 
13.6 million children with chronic health conditions that place them at 
increased risk for critical illness. 

These children have a greater than three-fold likelihood of critical illness, 
when compared to their healthy peers.  That is, compared with previously 
healthy children, these children are more than three times more likely to 
need critical care during an episode of acute illness.  This excess risk in 
chronically ill children was found to decrease with age, with younger 
children (zero to two years) having a 6.7 times greater relative risk of 
critical illness.  Critical illness in this developmentally critical age 
group is especially disruptive, as it interrupts educational plans and peer 
interactions, and places considerable stress on the families.  It is likely 
that the potential for developmental achievement is permanently constrained 
by multiple critical illnesses. 
  
All of these factors underscore the importance of research designed to 
address the care of critically ill children and their ability to transition 
to maximal function outside the intensive care unit, in chronic care 
facilities, schools, and at home with their families and peers.  In the past 
decade, increased scientific discovery in the biomedical and engineering 
sciences has provided an opportunity for developing a wide range of new 
technologies, with the potential to enhance survival and quality of life 
after critical illness in childhood and to decrease morbidity and functional 
disability. 

The pediatric critical care unit is an arena in which state-of-the-art 
technology and problem solving have evolved to decrease mortality.  Such care 
is labor intensive and expensive, and the environment, while conducive to the 
formulation of ideas for technological innovation, is not one in which time 
and resources are set aside for the study and implementation of new ideas. 
While mortality has drastically decreased in the last 15 years in pediatric 
intensive care units, more children survive with disabling outcomes.  
Innovative technologies to make state-of-the-art pediatric critical care less 
invasive, more cost-effective, and thereby less disabling are urgently 
needed.  This RFA seeks to expedite the utilization of small business 
innovation in problem solving in pediatric critical care and rehabilitation 
practice.

Research Scope

This RFA encourages applicants to take advantage of the SBIR/STTR program for 
multidisciplinary research projects that develop technology to enhance the 
function of children with critical illness and residual disabilities.  The 
initiative is intended to be broad, and open to all relevant research ideas.  
Understanding the effects of critical illness and disability on growth, and 
development, morbidity and risk, as well as adaptation to school and home, 
requires consideration of diverse pathophysiological processes, as well as an 
understanding of developmental medicine, critical care, and rehabilitation. 
Proposals to develop technologies and devices, as well as assessment tools 
and strategies to minimize functional disability after critical illness of 
childhood, are within the scope of this initiative.

The increasing population of children with special needs, many of them 
survivors of pediatric critical care, have many adaptive needs in 
reintegration into home, school and community.  Impaired mobility, altered 
airway anatomy and physiology, altered pulmonary compliance and resistance, 
musculoskeletal deformities, and impaired neurodevelopment status make such 
children especially vulnerable.  

The effects of these conditions include (but are not limited to) obesity, 
obstructive sleep apnea, hypoxia, altered exercise tolerance, poor peer 
relationships and school integration, frequent serious infections, and the 
need for repetitive critical care admissions and interventions.  Even 
children without pre-morbid underlying special needs may need assistance with 
reintegration into family life following critical illness.  This RFA solicits 
applications to address these needs in the pediatric critical care unit and 
beyond, in the rehabilitation setting, in schools, and in homes and families.

Development and testing of innovative critical care and rehabilitation 
technologies of many types would be responsive to this solicitation.  For 
example, avoiding invasive, expensive mechanical ventilation, by aggressive 
application of less invasive technologies, might decrease the morbidity, 
mortality, and expense of the care of children with known underlying 
susceptibility to respiratory failure.  More accurate, less invasive 
monitoring of oxygenation, ventilation, and cardio-pulmonary function and 
airway patency would contribute substantially to the health of children who 
are critically ill or are at risk for critical illness due to underlying 
medical fragility.

Examples of research that would be considered responsive to this solicitation 
are listed below.  This is not meant to be a delimiting, exhaustive, or 
exclusionary list:

o  Develop innovative assistive devices and techniques to minimize residual 
disability and the impact of critical illness on physical, behavioral, and 
cognitive development in childhood.

o  Develop innovative technologies to enable children normally confined to 
settings where intensive care is available to participate more fully in 
community, family, and school life outside the intensive care unit.

o  Develop technologies to extend the ability to assess medically fragile 
children without interrupting schooling, community activities or family life.

o  Develop technologies and strategies that will minimize the need for 
outpatient visits or hospitalization and the risk that minor childhood 
illnesses will become life threatening.

o  Develop environmental designs and modifications that enhance and improve 
functional adaptations and outcomes for critically ill children.

o  Develop assessment tools that allow clinicians to properly identify and 
evaluate problems and changes in the health of children at risk for critical 
illness.

o  Develop improved assessment measures that link pediatric critical care and 
rehabilitation interventions and outcomes.

o  Develop improved training strategies and curricula for pediatric critical 
care professionals on the appropriate selection and use of assistive 
technologies.
 
MECHANISM OF SUPPORT

This RFA uses the SBIR and STTR mechanisms, which are set-aside programs. As 
an applicant, you will be solely responsible for planning, directing, and 
executing the proposed project.  Future unsolicited, competing continuation 
applications based on this project will compete with all SBIR/STTR 
applications and will be reviewed according to the customary peer review 
procedures.  The anticipated award date is July 1 1, 2004.  Applications that 
are not funded in the competition described in this RFA may be resubmitted as 
NEW SBIR/STTR applications using the standard receipt dates for NEW 
applications described in the current SBIR/STTR Omnibus Solicitation.  

This RFA uses just-in-time concepts.  It also uses the modular budgeting 
format.  Specifically, if you are submitting an application budget of 
$100,000 total costs (direct, F&A and fee) or less, use the modular format 
and instructions as described in the current SBIR/STTR Omnibus Solicitation.  
Otherwise follow the instructions for non-modular research grant 
applications.  This program does not require cost sharing as defined in the 
current NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.

Except as otherwise stated in this RFA, awards will be administered under NIH 
grants policy as stated in the NIH Grants Policy Statement, March 2001, 
available at http://grants.nih.gov/grants/policy/nihgps_2001.  

Applications may be submitted for support as Phase I STTR (R41) or Phase I 
SBIR (R43) grants.  

PROJECT PERIOD AND AMOUNT OF AWARD

The SBIR/STTR Omnibus Solicitation indicates the statutory guidelines of 
funding support and project duration periods for SBIR and STTR Phase I and 
Phase II awards.  For this RFA, budgets up to $125,000 total costs per year 
and time periods up to two years for Phase I may be requested.  Total costs 
include direct costs, F&A, and fee/profit.  

FUNDS AVAILABLE

The NICHD intends to commit approximately $750,000 in total costs [Direct 
plus Facilities and Administrative (F & A) costs plus fee] in FY 2004 to 
support four to six Phase I grants in response to this RFA.  Although the 
financial plans of the NICHD 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

Eligibility requirements are described in the SBIR/STTR Omnibus Solicitation.  
Only small business concerns are eligible to submit SBIR/STTR applications.  
A small business concern is one that, on the date of award for both Phase I 
and Phase II agreements, meets ALL of the criteria as described in the 
current SBIR/STTR Omnibus Solicitation.

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.  On an SBIR application, the principal 
investigator must have his/her primary employment (more than 50%) with the 
small business at the time of award and for the duration of the project. The 
PI on an STTR application may be employed with the small business concern or 
the participating non-profit research institution as long as s/he has a 
formal appointment with or commitment to the applicant small business 
concern, which is characterized by an official relationship between the small 
business concern and that individual. 

SPECIAL REQUIREMENTS

In order to ensure maximum progress in the projects funded by this RFA and to 
realize the maximum benefit for the research community, all funded 
investigators will be invited to an annual meeting.  The annual meeting will 
facilitate sharing of progress and research insights with other 
investigators.  In the preparation of the budget for the grant application, 
applicants should request travel funds for the Principal Investigator and one 
additional senior investigator to attend this annual meeting.

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into two 
areas:  scientific/research and financial or grants management issues:  

o Direct your questions about scientific/research issues to:  

Carol E. Nicholson, M.D., M.S.
Pediatric Critical Care and Rehabilitation Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, 2A03, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6843
FAX:  (301) 402-0832
Email:  cn103e@nih.gov 

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

Kathy Hancock
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-5482
FAX:  (301) 402-0915
Email:  kh246t@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 NIH 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 E. Nicholson, M.D., M.S.
Pediatric Critical Care and Rehabilitation Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, 2A03, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6843
FAX:  (301) 402-0832
Email:  cn103e@nih.gov

SUBMITTING AN APPLICATION

The PHS 398 research grant application must be used for all SBIR/STTR Phase 
I, Phase II and Fast-Track applications (new and revised.)  The PHS 398 is 
available at http://grants.nih.gov/grants/funding/phs398/phs398.html.  
Prepare your application in accordance with the SBIR/STTR Omnibus 
Solicitation and the PHS 398.  Helpful information for advice and preparation 
of the application can be obtained at: 
http://grants.nih.gov/grants/funding/sbirgrantsmanship.pdf.  The NIH will 
return applications that are not submitted on the 5/2001 version of the PHS 
398.  For further assistance contact GrantsInfo, Telephone: (301) 435-0714, 
Email: GrantsInfo@nih.gov. 

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS:  This RFA uses the 
modular budgeting format. Specifically, if you are submitting an application 
budget of $100,000 total costs (direct, F&A and fee) or less, use the modular 
format and instructions as described in the SBIR/STTR Omnibus Solicitation.

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 five 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)

RECEIPT OF APPLICATIONS:  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 eight 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.  While the 
investigator may still benefit from the previous review, the RFA application 
is not to state explicitly how.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NICHD.  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 CSR 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 the application in order to judge the likelihood that the proposed 
research will have a substantial impact on the pursuit of these goals within 
the context of the SBIR/STTR Program: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment

o  ALL SBIR/STTR APPLICATIONS:

(1)  Significance:  Does the proposed project have commercial potential to 
lead to a marketable product or process? Does this study address an important 
problem?  What may be the anticipated commercial and societal benefits of the 
proposed activity?  If the aims of the application are achieved, how will 
scientific knowledge be advanced?  Does the proposal lead to enabling 
technologies (e.g., instrumentation, software) for further discoveries?  Will 
the technology have a competitive advantage over existing/alternate 
technologies that can meet the market needs? 

(2)  Approach:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project?  Is the proposed plan a sound approach for establishing technical 
and commercial feasibility?  Does the applicant acknowledge potential problem 
areas and consider alternative strategies?  Are the milestones and evaluation 
procedures appropriate? 

(3)  Innovation:  Does the project challenge existing paradigms or employ 
novel technologies, approaches or methodologies?  Are the aims original and 
innovative? 

(4)  Investigators: Is the Principal Investigator capable of coordinating and 
managing the proposed SBIR/STTR?  Is the work proposed appropriate to the 
experience level of the Principal Investigator and other researchers, 
including consultants and subcontractors (if any)? Are the relationships of 
the key personnel to the small business and to other institutions appropriate 
for the work proposed? 

(5)  Environment:  Is there sufficient access to resources (e.g., equipment, 
facilities)?  Does the scientific and technological 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? 

o  AMENDED APPLICATIONS:

In addition to the above criteria, the following criteria will be applied to 
revised applications.

(1)  Are the responses to comments from the previous SRG review adequate? 

(2)  Are the improvements in the revised application appropriate? 

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 additional information and 
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 additional information and Inclusion Criteria in the sections 
on Federal Citations, below).

DATA SHARING:  The adequacy of the proposed plan to share data. 

ADDITIONAL CONSIDERATIONS:  The following items may be also be considered by 
reviewers but will not be included in the determination of scientific merit.

BUDGET:  The reasonableness of the proposed budget may be considered.
For all applications, is the percent effort listed for the PI appropriate for 
the work proposed?  On applications requesting up to $100,000 total costs, is 
the overall budget realistic and justified in terms of the aims and methods 
proposed?  On applications requesting over $100,000 in total costs, is each 
budget category realistic and justified in terms of the aims and methods? 

PERIOD OF SUPPORT:  The appropriateness of the requested period of support in 
relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  September 15, 2003
Application Receipt Date:  October 15, 2003
Peer Review Date:  March 2004
Council Review:  May 2004
Earliest Anticipated Start Date:  July  01, 2004

AWARD CRITERIA

Applications submitted in response to an RFA will compete for available funds 
with all other recommended SBIR and STTR applications.  The following will be 
considered in making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program 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 

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 "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.

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).  

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 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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