Full Text PAR-97-074
NIH GUIDE, Volume 26, Number 23, July 18, 1997
PA NUMBER:  PAR-97-074
P.T. 34

  Instrumentation, Biological 
  Instrumentation, Scientific 

National Center for Research Resources
Application Receipt Date: October 17, 1997
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,
physical sciences, 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 improved human
The technologies/instruments/methodologies to be developed under this
program must be applicable to a variety of NIH research areas.
Applications to develop technologies that apply only to one
categorical NIH institute or a specific disease, generally do not
meet the guidelines for this program. Such applications will be
considered only if the applicant clearly demonstrates the long-term
potential of the technology for having a broad impact on biomedical
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).
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.
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 or
supplant projects currently supported by Federal or non-Federal
funds, nor to provide interim support for projects under review.
Following completion of the exploratory (R21) grant, investigators
are encouraged to seek continuing support for research through other
NIH grant mechanisms.
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 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 innovative, unusually imaginative or drastically
different from past paradigms with the potential to have a broad
impact on biomedical research or on improved health care. The
proposal is likely to contain an element of risk as it must encompass
work at the frontiers or the limits of understanding of a problem or
because no historical basis exists for the proposed approach.
Applications submitted for new assays, such as for enzymes or
macromolecules, meet the definition of technology development for
this program only when the proposed new assays involve the use of a
fundamental new principle or paradigm in engineering,
instrumentation,  physical sciences, mathematics or computer science,
not previously demonstrated.
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.
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:
1.  Face Page of the application:
Item 2.  Check the box marked "YES" and type the number and title of
this program announcement.
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.
Direct costs requested for the proposed period may not exceed
2. Description:
As part of the description, identify concisely the technology or
methodology to be developed; its innovative nature; its relationship
to presently available capabilities and its expected impact on
biomedical research.
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.
Furthermore, preliminary data are not required, but when available,
should be included. 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.
Item b:
Under Background Significance, elaborate on the innovative nature of
the proposed research. Clarify how this project is a significant
departure from ongoing work. Explain the potential of the proposed
technology for having a broad impact on biomedical research or on
improved human health. Clearly identify how the project, if
successful, would result in new capabilities for research, and how
these capabilities would differ from existing technologies.
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,
10. Appendix:
Color illustrations or original photographs may be included in an
Appendix. These are allowed only if they are copies of black and
white figures appearing in the body of the application. No other
appendix material is permitted.
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, including four original copies of
appendix material, to:
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)
At the time of submission send two additional copies of the
application with two original copies of the appendix material
(original illustrations and photographs), 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 is:
Application receipt date: October 17, 1997
NCRR Committee Review: January/February
Council Review: May
Earliest Funding: July
Only one R21 grant application may be submitted by a principal
investigator in response to this program announcement.  Applicants
may not submit a research project grant application to PHS on the
same topic concurrently with the submission of this exploratory grant
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
Applications that are responsive to the program announcement will be
evaluated for scientific and technical merit by an initial review
group 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  Does the proposed project have potential for developing ground-
breaking technology or methodology that may lead to significant
expansion of biomedical research horizons or a paradigm shift in
research or improved human health?
o  Degree of innovation; does the project challenge existing
paradigms or develop new methodologies or technologies?
o  Does the project have potential for broad impact on biomedical
o  Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of
the project? Does the applicant acknowledge potential problem areas
and consider alternative tactics?
o  Is the investigator appropriately trained and well suited to carry
out this work?
o  Are the available and requested resources adequate to conduct the
proposed work?
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 must 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.
In addition to review of the merit of the application, the review
committee will also examine the appropriateness of the requested
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
Inquiries are encouraged.  The opportunity to clarify any issues or
questions from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
Subject areas: bioengineering, biomedical computing
Dr. Richard Dubois
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
Subject areas: imaging, molecular structure and function
Dr. Abraham Levy
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
Subject areas: electron microscopy, mass spectrometry
Dr. Mary Ann Markwell
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
Subject areas: all other
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
Or send an email inquiry to:
Direct inquiries regarding fiscal matters to:
Ms. Louise Amburgey
Office of Grants and Contracts Management
National Center for Research Resources
6705 Rockledge Drive, Room 6086, MSC 7965
Bethesda, MD  20892-7965
Telephone:  (301) 435-0844
Email:  louisem@ep.ncrr.nih.gov
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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