INNOVATIONS IN POWERED MOBILITY DEVICES: SBIR/STTR
RELEASE DATE: June 30, 2003
RFA: HD-03-023
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 23, 2003
APPLICATION RECEIPT DATE: October 23, 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
https://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 National Center for Medical Rehabilitation Research (NCMRR) at the
National Institute of Child Health and Human Development (NICHD) invites
applications from small businesses for research and development of powered
mobility devices for individuals with disabilities. A key aspect of this RFA
is to encourage applicants to consider paradigm shifts to improve transport
devices such as wheelchairs and scooters through improved design, use of
materials and state-of-the-art technology. Research areas appropriate for
this include, but are not limited to: reducing the weight, improving the
power supply, and designs to improve portability.
RESEARCH OBJECTIVES
Background
This RFA solicits applications to address the development of a new generation
of powered mobility devices that are safe, stable, comfortable, and
affordable. Approximately 14 percent of the American population has a
disability. A growing number of these children and adults have mobility
limitations requiring a powered mobility device for local transport.
Existing powered mobility devices are rather heavy and bulky, limiting the
interaction with the environment and independence of the user. This
restricts the individual's and personal assistant's ability to physically
move or lift the mobility device for transport in automobiles, taxis, and in
luggage racks of public transportation such as trains, buses, and airplanes.
One of the major contributors to the weight is the battery needed to power
the device. Other factors contributing weight are the frame and materials
used in the construction of current powered mobility devices.
Research Scope
New designs for powered mobility devices incorporating lightweight materials
and including features such as folding would be responsive to this
solicitation. In addition, the development of new lightweight power supplies
would also be responsive to this solicitation.
Applicants are encouraged to team with other organizations to obtain needed
expertise to create unique systems enhancing the capability and safety of
mobility devices. The following research topics are provided as examples;
they are not listed in any priority order and are not intended to be all-
inclusive or restrictive. Applications will be considered responsive
addressing topics such as:
o Lightweight, more efficient power sources for transport vehicles;
o More efficient motors and enhanced drive mechanisms;
o Improved wheel design, size, and placement;
o Improved seating and postural support systems;
o Control systems for powered mobility devices; and
o Improved frame material and design features enhancing compatibility with
the user environment as well as increasing strength and reducing weight.
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, 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
https://grants.nih.gov/archive/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 https://grants.nih.gov/grants/policy/nihgps_2001.
Applications may be submitted for support as Phase I STTR (R41), Phase I SBIR
(R43) grants or the SBIR/STTR FAST-TRACK option as described in the SBIR/STTR
Omnibus Solicitation. 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 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 $400,000 in total costs [Direct
plus Facilities and Administrative (F & A) costs plus fee] in FY 2004 to
support up to six Phase I grants or one Fast Track grant 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 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 two
areas: scientific/research and financial or grants management issues:
o Direct your questions about scientific/research issues to:
Louis Quatrano, Ph.D.
National Center for Medical Rehabilitation Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, 2A03, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 402-4221
FAX: (301) 402-0832
Email: quatranl@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:
Louis Quatrano, Ph.D.
National Center for Medical Rehabilitation
National Institute of Child Health and Human Development
6100 Executive Boulevard, 2A03, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 402-4221
FAX: (301) 402-0832
Email: quatranl@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 https://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:
https://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:
https://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?
o PHASE I/PHASE II FAST-TRACK APPLICATIONS:
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.
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 23, 2003
Application Receipt Date: October 23, 2003
Peer Review Date: 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
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
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
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at
https://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
https://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
https://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
https://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
https://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.