ACCESSIBLE HEALTH PROMOTION AND FITNESS FOR PERSONS WITH DISABILITIES:  
SBIR/STTR 

RELEASE DATE:  October 30, 2003

RFA Number:  RFA-HD-03-013

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION:  
National Institutes of Health (NIH) 
 (http://www.nih.gov)
 
COMPONENTS OF PARTICIPATING ORGANIZATION:  
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:  March 17, 2004
APPLICATION RECEIPT DATE:  April 16, 2004

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanisms 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

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

The purpose of this initiative is to promote innovative design modifications 
of diagnostic medical devices and fitness equipment that will be suitable for 
facilities and/or for home in order to increase accessibility for persons with 
disabilities, improve their health and wellness, and reduce the occurrence of 
secondary conditions.  This initiative encourages the use of universal design 
principles for 1) diagnostic medical devices in healthcare facilities (but not 
modification of the facilities themselves), or 2) fitness and health promoting 
equipment in fitness centers or home settings.  Applicants should identify a 
potential barrier unique to persons with physical disabilities and propose new 
designs or substantial modifications of existing devices or equipment.  This 
initiative primarily focuses on improving access to biomedical and fitness 
equipment, but does not extend to architectural modifications, improving 
mobility in general (e.g., prosthetics, orthotics or wheelchair design) or 
adaptations to equipment and devices that primarily function in a vocational, 
educational or outside recreational setting.

RESEARCH OBJECTIVES

Background

An estimated 54 million persons in the United States, or nearly 20 percent of 
the population, currently live with disabilities, and this population appears 
to be increasing.  Medical care expenditures for persons with disabilities are 
rising as well.  The health promotion and disease prevention needs of people 
with disabilities are important regardless of the presence of any disease, 
condition or injury that has long-term consequences.  People with disabilities 
actually have increased health concerns, particularly because they are 
susceptible to the identical health concerns as able-bodied individuals and 
have increased susceptibility to other conditions because of inactivity due to 
their disability.  Unfortunately, many people with disabilities are denied 
access to preventive and diagnostic healthcare due to barriers related to 
medical devices in physician's offices, diagnostic centers, and clinics, or 
are limited in their health promotion activities due to lack of appropriate 
equipment designed to promote physical health in fitness centers or at home. 
The objectives of this initiative are pertinent to the Healthy People 2010 
effort (http://www.healthypeople.gov/) to increase the quality and years of a 
healthy life and to eliminate disparities among people.  It is also very 
relevant to the President's New Freedom Initiative 
(http://www.hhs.gov/newfreedom/init.html). 

Scope of Research

The objective of this initiative is to design and validate alterations to 
medical diagnostic devices or exercise equipment that improve access for 
persons with physical disabilities in order to improve health and reduce the 
occurrence of secondary complications.  Insufficient data exist from 
adequately powered descriptive studies to provide quantitative and qualitative 
standards of desirable fitness levels in persons with disabilities.  It is 
likely that improvement in medical diagnostic and fitness devices will include 
a process to acquire information that could lead to such standards.  For 
example, the development of standards of age-appropriate resting and training 
heart rates in individuals with specific disabilities is well within the scope 
of this initiative.

Responsive grant applications will clearly and carefully identify, describe, 
and justify in detail the targeted accessibility or barrier, wellness, and 
disability issues and considerations of the proposed project.  Proposed 
projects involving equipment or devices will thoroughly consider the potential 
device-user interaction, device design and safety, as well as device 
usability, validity, and reliability.  All projects should address milestones, 
assessment criteria, and outcome measures and include a demonstration of 
improved accessibility.  The Phase II objectives should include thorough 
validation testing and measurement.  Proposals that target fitness should 
include a goal of demonstrating that the proposed design modifications can 
lead to not only better accessibility, but also improved function or reduced 
disability.  Adequate standard physiological data may not exist for many 
populations of people with specific disabilities.  It is expected that a 
proposal on fitness will address the resting and exercise physiology of the 
targeted population in order to demonstrate the effectiveness of the proposed 
device or equipment.  When human subjects research is proposed, the 
application must thoroughly and completely address all of the pertinent issues 
described in the application instructions.  An adequately focused project will 
have an expected scope and completion time that will be compatible with the 
NIH SBIR/STTR program.

The following provides examples of modifications that could improve health 
outcomes for persons with disabilities.  This is not meant to be a 
comprehensive or restrictive list of appropriate responses to this RFA, but 
merely examples of research needs:

o Development or modification of fitness equipment for individuals with 
disabilities (e.g., musculoskeletal abnormalities and reduced strength or 
musculoskeletal function, amputations, partial paralysis, stroke, etc.) to 
improve or maintain cardiovascular conditioning, pulmonary function, balance, 
coordination, muscle tone and strength, and ultimately improve function and 
reduce disability;

o Modifications in medical equipment or fitness devices to accommodate 
individuals with spasticity, tremors, musculoskeletal deformities or other 
physical impairments;

o Specialized devices to dynamically monitor general fitness activity, 
cardiovascular function, metabolism, muscle physiology or other aspects of 
health status for individuals with disabilities;

o Modifications in the design of examination tables and chairs, and other 
large medical equipment, that improve access and proper positioning of 
patients with physical disabilities; 

o Modifications in the design of imaging equipment (e.g., fMRI, X-ray), 
stress-testing devices, electrocardiogram, bone density, mammography or other 
diagnostic equipment to accommodate persons with disabilities;

o Specific modifications to improve access for women with disabilities to 
gynecological and obstetric exams and procedures, or other specialized medical 
needs and health support; 

o Specific modifications to improve access for children with disabilities to 
standard pediatric and adolescent biomedical devices and exercise equipment.

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 September 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 budget format and 
instructions as described in the current SBIR/STTR Omnibus Solicitation.  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; Phase II STTR (R42) or Phase II SBIR (R44) grants; or the 
SBIR/STTR FAST-TRACK option as described in the SBIR/STTR Omnibus 
Solicitation.  Phase II applications in response to this RFA will only be 
accepted as competing continuations of previously funded NIH Phase I SBIR/STTR 
awards.  The Phase II application must be a logical extension of the Phase I 
research but not necessarily a Phase I project supported in response to this 
RFA.  Fast Track applications will benefit from expedited evaluation of 
progress following the Phase I feasibility study for transition to Phase II 
funding for expanded developmental work. 

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 $100,000 direct costs per year 
and time periods up to three 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 $600,000 in total costs [Direct plus 
Facilities and Administrative (F & A) costs plus fee/profit] in FY 2004 to 
support four to six Phase I and/or Phase II applications under the SBIR/STTR 
set-aside funding mechanism.  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. At this time, it is not known if this RFA will be 
reissued. 

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 percent) 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. 

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:  

Nancy L. Shinowara, Ph.D.
National Center for Medical Rehabilitation Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 2A03, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 402-2242
FAX:  (301) 402-0832
Email:  shinowara@nih.gov

o Direct your questions about peer review issues to:  

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

Nancy L. Shinowara, Ph.D.
National Center for Medical Rehabilitation Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 2A03, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 402-2242
FAX:  (301) 402-0832
Email:  shinowara@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.)  Effective October 1, 
2003, 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 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. 

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 (for USPS EXPRESS or REGULAR MAIL)
Bethesda, MD  20817 (for EXPRESS/COURIER NON-USPS SERVICE)

To expedite the review process, at the time of submission, send two additional 
copies of the application to:  

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD  20892-7510
Rockville, MD  20852 (for express/courier service)

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 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 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 NICHD.  Incomplete applications will not be reviewed.  
If the application is not responsive to the RFA, NIH staff may contact the 
applicant to determine whether to return the application to the applicant or 
submit it for review in competition with unsolicited applications at the next 
appropriate NIH review cycle.  

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

o Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications under 
review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the National 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 evaluate 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.  The scientific review group will address and consider each 
of the following criteria in assigning the application’s overall score:

o Significance 
o Approach 
o Innovation
o Investigator
o Environment

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? 

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).

ADDITIONAL REVIEW 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.

PHASE II APPLICATIONS:  In addition to the above review criteria, reviewers 
will consider:

(1) How well did the applicant demonstrate progress toward meeting the Phase I 
objectives, demonstrating feasibility, and providing a solid foundation for 
the proposed Phase II activity? 

(2) Did the applicant submit a concise Commercialization Plan (formerly 
Product Development Plan) that adequately addresses the seven areas described 
in the Research Plan item J? 

(3) Does the project carry a high degree of commercial potential, as described 
in the Commercialization Plan? 

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? 

PHASE I/PHASE II FAST-TRACK APPLICATION REVIEW CRITERIA:

For Phase I/Phase II Fast Track applications, the following criteria also will 
be applied:

(1) Does the Phase I application specify clear, appropriate, measurable goals 
(milestones) that should be achieved prior to initiating Phase II? 

(2) Did the applicant submit a concise Commercialization Plan (formerly 
Product Development Plan) that adequately addresses the seven areas described 
in the Research Plan, item J? 

(3) To what extent was the applicant able to obtain letters of interest, 
additional funding commitments, and/or resources from the private sector or 
non-SBIR/ STTR funding sources that would enhance the likelihood for 
commercialization? 

(4) Does the project carry a high degree of commercial potential, as described 
in the Commercialization Plan? 

Phase I and Phase II Fast-Track applications that satisfy all of the review 
criteria will receive a single rating.  Failure to provide clear, measurable 
goals may be sufficient reason for the scientific review group to exclude the 
Phase II application from Fast-Track review.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  March 17, 2004
Application Receipt Date:  April 16, 2004
Peer Review Date:  February/March 2004
Council Review:  September 2004
Earliest Anticipated Start Date:  September 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

For FAST-TRACK applications, the Phase II portion may not be funded until a 
Phase I final report and other documents necessary for continuation have been 
received and assessed by program staff that the Phase I milestones have been 
successfully achieved. 

REQUIRED FEDERAL CITATIONS

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

DATA AND SAFETY MONITORING PLAN:  Data and safety monitoring is required for 
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II); efficacy, 
effectiveness and comparative trials (phase III).  The establishment of data 
and safety monitoring boards (DSMBs) is required for multi-site clinical 
trials involving interventions that entail potential risk to the participants  
(NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and 
Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

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

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

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.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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