Full Text PAR-97-014
 
INNOVATIVE APPROACHES TO DEVELOPING NEW TECHNOLOGIES
 
NIH GUIDE, Volume 25, Number 42, December 6, 1996
 
PA NUMBER:  PAR-97-014
 
P.T. 34

Keywords: 
  BIOMEDICAL ENGINEERING 
  INSTRUMENTS/INSTRUMENTATION/DEVICE 

 
National Center for Research Resources
 
Application Receipt Date:  February 13, 1997
 
PURPOSE
 
The mission of the Biomedical Technology area of the NCRR is to
support research to identify, create and develop innovative
technologies and to provide these technologies for biomedical
research.  Areas of emphasis are biomedical engineering, biomedical
computing, and technologies for the study of structure and function
at all levels of living systems.
 
The purpose of this program announcement (PA) is to encourage
submission of new Exploratory/Developmental Grant (R21) applications
to explore new research paradigms in engineering, instrumentation,
physics, mathematics or computer science as applied to biomedical
research.  The projects should provide the opportunity to develop new
technologies, methods, devices, and materials that provide greater
understanding of fundamental elements of biological phenomena.  These
efforts should lead to new approaches to the solution of basic
research questions in order to prevent, diagnose, and treat disease
and disability and ultimately to improve human health.
 
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 PA is
related to several of the priority areas.  Potential applicants may
obtain a copy of "Healthy People 2000" (Full Report:  Stock No. 017-
001-00474-0 or Summary Report:  Stock No.017-001-00473-1) through the
Superintendent of Documents, Government Printing Office, Washington,
D.C. 20402-9325  (telephone 202/512-1800).
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by foreign and domestic nonprofit and
for-profit organizations, public and private, such as universities,
colleges, hospitals, laboratories, units of state and local
governments, and eligible agencies of the Federal government.
Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply.
 
MECHANISM OF SUPPORT
 
Support of this activity will be through the National Institutes of
Health (NIH) exploratory grants (R21) mechanism, with direct costs
limited to $75,000 per year for up to two years.  Indirect costs will
be provided.  Although these grants are not renewable, they are
expected to provide the opportunity to collect sufficient preliminary
data to apply for future support from either the NCRR or other NIH
Institutes and Centers.  These funds may not be used to supplement
projects currently supported by Federal or non-Federal funds, nor to
provide interim support for projects under review by the Public
Health Service, nor to support thesis or dissertation research.
Following completion of the exploratory (R21) grant, investigators
are encouraged to seek continuing support for research through other
NIH grant mechanisms.
 
RESEARCH OBJECTIVES
 
The purpose of this PA is to provide the opportunity to:
 
o  explore new approaches, test imaginative new ideas or to challenge
existing paradigms in technologies related to biomedical research;
 
o  develop significant changes in an existing high technology
important to biomedical research; or
 
o  translate a scientific concept into the basis for a future
technology that leads to the solution of important biomedical
research problems.
 
The research must be unusually imaginative or drastically different
from past paradigms with the potential to lead to a significant
expansion of biomedical research horizons.  The proposal should
contain an element of risk as it must encompass work at the frontiers
or the limits of understanding of a problem.
 
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 are
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
provisions that are substantially different from the 1990 policies.
 
All investigators proposing research involving human 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 (FR 59 14508-14513) and reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.
 
Investigators also may obtain copies of the policy from the program
staff listed under INQUIRIES.  Program staff also may provide
additional relevant information concerning the policy.
 
APPLICATION PROCEDURES
 
Applications are to be submitted on the grant application form PHS
398 (rev. 5/95) and prepared according to the instructions provided
except for the following related to "C. SPECIFIC INSTRUCTIONS."
Application kits are available at most institutional offices of
sponsored research and may be obtained from the Office of Extramural
Outreach and Information Resources, 6701 Rockledge Drive, MSC 7910,
Bethesda, MD 20892-7910, telephone 301/710-0267, email:
asknih@odrockm1.od.nih.gov.
 
C. SPECIFIC INSTRUCTIONS
 
1.  Face Page of the application:
 
Item 2.  Check the box marked "YES" and type the number and title of
this program announcement.
 
Item 7a and 8a, DIRECT COSTS REQUESTED FOR INITIAL BUDGET PERIOD; and
DIRECT COSTS REQUESTED FOR PROPOSED PERIOD OF SUPPORT:
 
Direct costs are limited to a maximum of $75,000 per year for a
maximum of two years. The award may not be used to supplement an
ongoing project, and, because of the feasibility-testing nature of
the work, the support of salaries for student employees conducting
dissertation-related research is discouraged.
 
9.  Research Plan:
 
Item a., Specific Aims.  The instructions for this section suggest
that the applicant state "the hypotheses to be tested."  Since the
goal of this program announcement is to develop innovative
technologies, hypothesis testing per se may not be the driving force
in developing such a proposal and, therefore, may not be applicable.
Importantly, however, research that develops new technologies does
require the application of principles of the fields such as
engineering, materials science, physics, mathematics and computer
science.  Clear statements of these underlying principles within this
section are essential.
 
Items a-d:
 
Do not exceed a total of ten pages for items a-d in the Research
Plan. Tables and figures are included in the ten page limitation.
Applications that exceed the page limitation or NIH requirements for
type size and margins (refer to PHS 398 application for details) will
be returned to the applicant without further consideration.
 
The ten page limitation does not include items (e)-(i) (Human
Subjects, Vertebrate Animals, Literature Cited, Consortia,
Consultants).
 
10, Appendix: Appendix materials are not allowed.
 
Applications not following the above instructions will be returned to
the applicant without review.
 
Use the mailing label in the application kit to mail the original and
three copies of the application to:
 
DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, SUITE 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)
 
At the time of submission send two additional copies of the
application to:
 
Office of Review
National Center for Research Resources
6705 Rockledge Drive, Room 6018 - MSC 7965
Bethesda, MD  20892-7965
Bethesda, MD  20817 (for express/courier service)
 
The submission, review, and award schedule for this Program
Announcement for FY 1997 is:
 
The single application receipt date is February 13, 1997.
NCRR Committee Review:     June/July 1997
Council Review:            September 1997
Earliest Funding:          September 1997
 
Only one grant application may be submitted by a principal
investigator for this receipt date.  Applicants may not submit R01 or
R29 applications on the same topic concurrently with the submission
of this exploratory grant application.
 
REVIEW CONSIDERATIONS
 
Applications not adhering to application instructions described above
and those applications that are incomplete or nonresponsive to this
program announcement will be returned to the applicant without
review.
 
Applications that are responsive to the program announcement will be
evaluated for scientific and technical merit by a review committee
convened by the NCRR in accordance with NIH peer review procedures.
As part of the initial merit review, all applications will receive a
written critique and may undergo a process in which only those
applications deemed to have the highest scientific merit, generally
the top half of the applications, will be discussed, assigned a
priority score, and receive a second level review by the National
Advisory Research Resources Council, NCRR.
 
Review Criteria
 
o  degree of innovation of the proposed research;
 
o  presence of an element of risk because no historical basis exists
for the proposed approach;
 
o  potential of the investigation to lead to significant expansion of
biomedical research horizons.
 
o  appropriateness and adequacy of the approach, and methodology
proposed to carry out the research;
 
o  adequacy of proposed experimental equipment or materials;
 
o  adequacy of the investigator's background and training;
 
o  adequacy of the available and requested facilities;
 
In addition to review of the merit of the application, the review
committee will also examine the appropriateness of the requested
budget.
 
Investigators should be aware that NIH urges applicants to give added
attention, where feasible and appropriate, to the inclusion of
minorities and women in study populations.  If minorities and/or
women are not included in a given study involving human subjects, a
clear rationale for their exclusion should be provided.
 
The initial review group will also examine the adequacy of the
proposed means for protecting against or minimizing potential adverse
effects upon humans, animals or the environment.
 
AWARD CRITERIA
 
The award of grants is contingent on the receipt of applications of
high scientific merit; relevance to the mission of the Biomedical
Technology area of the NCRR; and the availability of appropriated
funds.
 
INQUIRIES
 
Inquiries are encouraged.  The opportunity to clarify any issues or
questions from potential applicants is welcome.
 
Direct inquiries regarding programmatic issues to:
 
Dr. Dov Jaron
Biomedical Technology
National Center for Research Resources
6705 Rockledge Drive Room 6160, MSC 7965
Bethesda, MD  20892-7965
Telephone:  (301) 435-0755
FAX:  (301) 480-3659
Email:  dov.jaron@nih.gov
 
Direct inquiries regarding fiscal matters to:
 
Mr. Paul Karadbil
Office of Grants and Contracts Management
National Center for Research Resources
6705 Rockledge Drive, Room 6205, MSC 7965
Bethesda, MD  20892-7965
Telephone:  (301) 435-0844
Email:  Paulk@ep.ncrr.nih.gov
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.371.  Awards are made under authorization of the
Public Health Service Act, Title III, Part A (Public Law 78-410), as
amended by Public Law 99-158, 42 USC 241 and 285) and administered
under PHS grants policies and Federal Regulations 42 CFR 52.  This
program is not subject to the intergovernmental review requirements
of Executive Order 12372 or Health Systems Agency review.
 
The PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-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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