TRAINING MATERIALS ON SURGICAL AMPUTATIONS, PROSTHETICS AND ORTHOTICS 
(SBIR/STTR)  

RELEASE DATE:  August 13, 2003

RFA Number:  RFA-HD-03-019  

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:  October 20, 2003

APPLICATION RECEIPT DATE:  November 18, 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 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 exception: 

o Special receipt date    

PURPOSE OF THIS RFA

The purpose of this RFA is to support the development of high-quality, 
innovative educational materials for a curriculum designed for training 
orthopedic and general surgical residents in surgical amputation techniques 
with regard to the interfacing and maintenance of a residual limb with 
prosthetics and orthotic devices.  The educational materials will include 
video, CD-ROM, and/or DVD technology that can be used in training programs 
throughout the country.  These materials could also be used in continuing 
medical education curricula.  Applications should clearly indicate the 
significance of the proposed training curriculum and its target audience, 
include scientifically sound research plans for development of the set of 
courses and its evaluation and validation, and an appropriate team of 
investigators with the adequate resources and environment. 

RESEARCH OBJECTIVES

Background

Medical training for surgeons on surgical amputation, prosthetics and 
orthotics across the country is highly variable and has led to very 
inconsistent and uneven practices.  Surgical and rehabilitation practices 
have advanced considerably and many more prosthetic and orthotic options for 
patients are currently available than in previous years.  Best surgical 
outcome practices depend on up-to-date awareness of the appropriate criteria 
for careful selection of a prosthetic or orthotic device with regard to the 
preparation of the residual limb and the specific needs and conditions of the 
patient.  Choosing these options requires an understanding of the benefits 
and costs of these alternatives.  Very few training curricula in orthopedics 
and general surgery are available for the acquisition of both state-of-the 
art surgical expertise and rehabilitation/prosthetics expertise.  The 
development of high-quality training materials will lead to more uniform 
training in surgical programs. 

Research Scope

This SBIR/STTR solicitation is to develop training programs that can be 
delivered via videotapes, CD ROMs, and/or DVDs with appropriate printed 
materials.  The training syllabus will be primarily directed toward surgical 
residency education, but may also include appropriate components for other 
members of the team, such as surgical nurses, therapists, bioengineers, 
prosthetists, etc.  The research approach for developing a functional 
training curriculum should include evaluation and validation methods with 
outcome measures. 

The proposed training curriculum may focus on pre- to post-surgical aspects 
of upper and/or lower limb amputation techniques for preparatory and/or final 
prosthetic or orthotic devices that will better enable the rehabilitation 
process of the patient.  The training curriculum will be comprehensive and 
may include considerations of cosmesis and quality of life issues, 
alternatives for design, materials, and manufacturing processes, residual 
limb and materials interface issues, immunological, pain, and safety 
problems, the proper fitting and care of prostheses and orthotics, new 
technology developments for improved functional outcomes, use of terminal 
devices, short-term and long-term medical management of patients with 
residual limbs and potential need for replacements, etc.  

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.  The anticipated award date is July 01, 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.  
Phase II applicants must 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 of up to $100,000 total costs per 
year and time periods of up to one year for Phase I may be requested.  

FUNDS AVAILABLE

The NICHD intends to commit approximately $400,000 in total costs [Direct 
plus Facilities and Administrative (F & A) costs plus fee/profit] in FY 2004 
to support one to four Phase I 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 competing renewal 
applications will be accepted and/or 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 Shinowara, Ph.D.
National Center for Medical Rehabilitation Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, 2A-03, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6838
FAX:  (301) 402-0832 
Email:  shinowan@mail.nih.gov 

o Direct your questions about peer review issues to:  

Daniel McDonald, Ph.D.
Chief, MOSS IRG
Center for Scientific Review
6701 Rockledge Boulevard, Room 4214, MSC 7814
Bethesda, MD  20892-7814
Telephone:  (301) 435-1215
Email:  mcdonald@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 IC staff to estimate the potential review workload and plan 
the review.

The letter of intent is to be sent by the date listed at the beginning of 
this document.  The letter of intent should be sent to:  

Nancy Shinowara, Ph.D.
National Center for Medical Rehabilitation Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, 2A-03, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6838
FAX:  (301) 402-0832
Email:  shinowan@mail.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) 710-0267, 
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 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:

Daniel McDonald, Ph.D.
Chief, MOSS IRG
Center for Scientific Review
6701 Rockledge Boulevard, Room 4214, MSC 7814
Bethesda, MD  20892-7814
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.    
Incomplete 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 Center for Scientific Review 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? 

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:

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:  October 20, 2003
Application Receipt Date:  November 18, 2003
Peer Review Date:  February/March 2004
Council Review:  June 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

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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