Full Text RR-94-005

BIOENGINEERING FOR DISEASE PREVENTION AND CONTROL

NIH GUIDE, Volume 23, Number 33, September 16, 1994

RFA:  RR-94-005

P.T. 34

Keywords: 
  BIOMEDICAL ENGINEERING 
  Disease Prevention+ 
  Disease Control+ 


National Center for Research Resources
The Whitaker Foundation

Application Receipt Date:  December 9, 1994

PURPOSE

The National Center for Research Resources (NCRR) and The Whitaker
Foundation invite investigator-initiated research project grant
applications for the research and development of devices, instruments,
and methodologies for the prevention and control of disease and
disabling conditions, and the reduction of health care costs and risks.
This solicitation is limited to novel, cost-effective bioengineering
approaches in the following areas: (1) microsensors, (2) physiological
monitoring, and (3) drug delivery systems.

The Whitaker Foundation (Whitaker) is a private, non-profit foundation
that encourages and supports biomedical engineering research and
training.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This Request
for Applications (RFA), Bioengineering for Disease Prevention and
Control, is related to the priority area of disease prevention.
Potential applicants may obtain a copy of "Healthy People 2000" (Full
Report:  Stock No. 017-001-00474-0, or "Healthy People 2000" Summary
Report:  Stock No. 017-001-00473-1) through the Superintendent of
Documents, Government Printing Office, Washington, DC 20402-9325
(telephone 202-783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by foreign and domestic, public and
private, non-profit and for-profit organizations such as universities,
colleges, hospitals, laboratories, units of State and local
governments, and eligible agencies of the Federal government.  Women
and minority investigators are encouraged to apply.

MECHANISM OF SUPPORT

The mechanism of NCRR support for this program will be the individual
research project grant (R01) and the total project period may not
exceed four years (three years for foreign applicants).  Responsibility
for the planning, direction, and execution of the proposed project will
be solely that of the applicant.  The NCRR and Whitaker plan to make
several awards each in Fiscal Year 1995.  The earliest possible award
date is July 1, 1995.

Because the nature and scope of the research proposed in response to
this RFA will vary, it is anticipated that the size of an award will
vary also.

This RFA is a one-time solicitation.  Future unsolicited competing
continuation applications will compete with all investigator-initiated
applications and be reviewed according to the customary peer review
procedures.

FUNDS AVAILABLE

The NCRR and Whitaker anticipate making a total of six to eight awards
for project periods of up to four years and anticipate that each will
set aside $1 million for the initial funding period.  Funding in
response to this RFA is dependent on the receipt of a sufficient number
of applications of high scientific merit.  Although this program is
provided for in the financial plans of the NCRR, the award of research
grants pursuant to this RFA by NCRR is contingent on the availability
of funds appropriated for Fiscal Year 1995.

RESEARCH OBJECTIVES

Background

The recent explosion of new knowledge in both the physical and
biological sciences offers unprecedented opportunities to develop
devices, sensors, instruments, and novel methods for use in basic
research and clinical care.  Many of these technologies, if used
appropriately, also should reduce health care costs.

The overall goal of this program, jointly announced and sponsored by
the NCRR and Whitaker, is to stimulate the development of new or
improved technologies that (1) have the potential to prevent or detect
disease and/or disabling conditions in the early stages, when often
they can be most efficiently and effectively treated; (2) will reduce
the length of hospital stay or eliminate the need for in-patient care
altogether; (3) will transfer health care procedures from the hospital
to the home or an ambulatory environment; and (4) will provide acute
and/or rehabilitation therapy based upon the specific physiological or
functional need of the patient.

Objectives and Scope

The objective of this program is to stimulate technological research
and development of novel, cost effective bioengineering approaches to
the prevention, treatment, or rehabilitation of disease or disabling
conditions. Applications need to be based on sound scientific,
engineering, and medical rationale.  There must be a clearly identified
target patient population to which the research is addressed. Since
work in technological innovation typically involves many disciplines
(e.g., physics, chemistry, biology, engineering), applicants should
consider using appropriate multidisciplinary teams in many cases.

Research supported under this program is restricted to the following
areas:

o  Microsensors.  The emphasis is on devices that are non-invasive,
minimally invasive, miniature, stable, and durable.

o  Physiological monitoring.  The emphasis is on innovative detection
and accurate readout.  The monitoring must be a cost effective
alternative to current practices.

o  Drug delivery systems.  The emphasis is on automating the delivery
of the accurate amount of medication when needed by the patient.

STUDY POPULATIONS

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results from
the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43)
and supersedes and strengthens the previous policies (Concerning the
Inclusion of Women in Study Populations, and Concerning the Inclusion
of Minorities in Study Populations) which have been in effect since
1990.  The new policy contains some new provisions that are
substantially different from the 1990 policies.

All investigators proposing research involving humans subjects should
read the "NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 28, 1994 (59 FR 14508-14513), and reprinted
in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23,
Number 11.

Investigators may obtain copies from these sources or from the NIH
program staff or contact person listed below.  Program staff may also
provide additional relevant information concerning the policy.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398
(rev. 9/91).  These forms are available at most institutional offices
of sponsored research and may be obtained from the Office of Grants
Information, Division of Research Grants, National Institutes of
Health, Westwood Building, Room 240, Bethesda, MD 20892, telephone
(301) 435-0714.

Instructions relating to the preparation of investigator-initiated R01
grant applications are provided with the PHS 398 form.

The RFA label available in the PHS 398 (rev. 9/91) application form
must be affixed to the bottom of the face page of the application.
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 2a
of the face page of the application form and the YES box must be
marked.

The completed original and three permanent, legible copies of the PHS
398 including the Checklist and appendix material must be delivered by
December 9, 1994, in one package to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At the time of submission, two additional copies of the complete
application including Checklist and appendix material must be sent to:

Dr. Chhanda Ganguly
Office of Review
National Center for Research Resources
Westwood Building, Room 10A15
Bethesda, MD  20892

Applications must be received by December 9, 1994.  Any application
received after this date will be returned to the applicant without
review.  The Division of Research Grants (DRG) will not accept any
application in response to this RFA that is essentially the same as one
currently pending initial review, unless the applicant withdraws the
pending application.  The DRG will not accept any application that is
essentially the same as one already reviewed.  This does not preclude
the submission of substantial revisions of applications already
reviewed, but such applications must include an introduction addressing
the previous critique.

Timetable

Application Receipt Date:   December 9, 1994
Initial Review:             February/March 1995
Council Review:             June 1995
Earliest Award Start Date:  July 1, 1995

Applicants are requested to submit a brief letter with their
application, co-signed by the institutional official, authorizing that
their application and summary statement be made available to Whitaker.
The absence of this authorization letter will preclude the possibility
of funding by Whitaker.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by DRG and
responsiveness by NCRR.  Incomplete applications will be returned to
the applicant without further consideration.  If NCRR staff find that
the application is not responsive to this RFA, it will be returned
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 NCRR in accordance with the peer review
criteria stated below.  As part of the initial merit review, a process
(triage) may be used by the initial review group in which applications
will be determined to be competitive or non-competitive based on their
scientific merit relative to other applications received in response to
this RFA.  Applications judged to be competitive will be discussed and
be assigned a priority score. Applications determined to be
non-competitive will be withdrawn from further consideration and the
principal investigator and the official signing for the applicant
organization will be promptly notified.

The following review criteria will be used by the Office of Review,
NCRR to evaluate the scientific and technical merit of each
application:

o  Originality or uniqueness of the approach(es) proposed.

o  Merit of the research plan for developing and testing the proposed
device or method.

o  Appropriateness of the target patient population that will be
addressed.

o  Project staffing with appropriate disciplines and training/prior
experience, and adequate facilities and equipment to successfully
achieve the stated goals.

o  Rational assessment of the anticipated health care cost reduction
resulting from the application of the proposed technological
innovation.

A second level of review will be provided by the National Advisory
Research Resources Council (NARRC), whose review may be based on policy
considerations as well as scientific merit.  Only applications
recommended by NARRC may be considered for funding by the NCRR.  Grants
made by Whitaker need to be approved by its Foundation Governing
Committee.

AWARD CRITERIA

The anticipated earliest award date is July 1, 1995.

Applications judged meritorious may be eligible for funding by either
the NCRR or by Whitaker.  Whitaker is not required to base its funding
solely on the priority assigned by the NCRR peer review group, and may
use its own peer review process to determine which projects it will
fund.  Factors to be considered by both sponsors include scientific and
technical merit, project content, and program relevance.  The NCRR will
administer grants funded by NIH in accordance with PHS policies.
Grants funded by Whitaker will be subject to that foundation's
policies, except that the indirect cost allowance of NIH will apply.

INQUIRIES

Written and telephone inquiries are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Richard DuBois, Ph.D
Biomedical Research Technology Program
National Center for Research Resources
5333 Westbard Avenue, Room 8A-15
Bethesda, MD  20892
Telephone:  (301) 594-7934

Peter Katona, Sc.D.
Biomedical Engineering Programs
The Whitaker Foundation
901 15th Street, N.W.
Washington, DC  20005
Telephone:  (202) 408-1505

Direct inquiries regarding fiscal matters to:

Mr. Paul Karadbil
Office of Grants and Contracts Management
National Center for Research Resources
5333 Westbard Avenue, Room 849
Bethesda, MD  20892
Telephone:  (301) 594-7955

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance
No. 93.371, Biomedical Research Technology.  Awards will be made under
authorization of the Public Health Service Act, Title III, Part A
(Public Law 78-410, as amended, 42 USC 241) and administered under PHS
grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74
and 92.  This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency review.

The Public Health Service (PHS) strongly encourages all grant
recipients to provide a smoke-free workplace and promote the non-use of
all tobacco products.  This is consistent with the PHS mission to
protect and advance the physical and mental health of the American
people.

.

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