INNOVATIVE APPROACHES TO DEVELOPING NEW TECHNOLOGIES

Release Date:  March 25, 1998

PA NUMBER: PAR-98-047

P.T.

National Center for Research Resources

Application Receipt Dates:  June 1 and October 1

PURPOSE

The purpose of this Program Announcement (PA) from the Biomedical Technology area
of the National Center for Research Resources (NCRR) is to encourage submission
of new Exploratory/Developmental Grant (R21) applications to support innovative
approaches to the development of technologies exploring new research paradigms
in engineering, instrumentation, physical sciences, mathematics or computer
science applicable to all areas of biomedical research.  The projects should
provide the opportunity to develop new technologies, methods, devices, and
materials that can be used in research aimed at gaining a greater understanding
of fundamental elements of biological phenomena as well as potentially providing
a basis for the development of new products useful in all aspects of biomedical
research and health care.  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 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, DC 20402-9325 (telephone 202/512-1800).

ELIGIBILITY REQUIREMENTS

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 research.

Applications that represent incremental changes in already established research
programs will not be considered.

Applications may be submitted by foreign and domestic, non-profit 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 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.

All applications responsive to this Program Announcement will be assigned to the
National Center for Research Resources for initial review and administration. 
Following review NCRR routinely communicates the results to NIH institutes and
centers to permit them to consider support of meritorious applications in areas
relevant to their specific interest.

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 substantial and meaningful 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 proposed research must be innovative, unusually imaginative or drastically
different from past paradigms and must have the potential for 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 areas such as epidemiology or behavioral research or
for new assays, such as for enzymes or macromolecules, meet the definition of
technology development for this program only if the proposed research involves
the use of a fundamental new principle or paradigm in engineering,
instrumentation, physical sciences, mathematics or computer science, not
previously demonstrated.  Validation or testing of an existing technique will not
be considered responsive to this PA.

Applications involving computational approaches to such areas as imaging, data
analysis, modeling, etc. must emphasize algorithm development.  Computational
approaches applied to drug discovery are appropriate to this announcement only
if they clearly move beyond currently utilized computational, structure-based,
and combinatorial approaches.

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
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public
Law 103-43).

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 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 Division of Extramural Outreach and
Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC
7910, Bethesda, MD 20892-7910, telephone 301/710-0267, Email: [email protected].

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, DIRECT COSTS REQUESTED FOR INITIAL BUDGET PERIOD:

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.  R21 awards
cannot be renewed beyond two years.

Item 8a, DIRECT COSTS REQUESTED FOR PROPOSED PERIOD OF SUPPORT:

Direct costs requested for the proposed period may not exceed $150,000.

2. Description:

As part of the description, identify concisely what new engineering, scientific,
or physical principle is to be employed and 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 from fields such as engineering, materials science,
physics, mathematics and computer science.  Clear statements within this section,
of these underlying principles, and the nature of the innovation involved, are
essential.

Item b., 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, Consultants/Collaborators).

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 to:

CENTER FOR SCIENTIFIC REVIEW
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 and all
five sets 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:  June 1 and October 1
NCRR Committee Review:     September/October and January/February
Council Review:            January and May
Earliest Funding:          March and 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 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 an initial review group convened by the
NCRR in accordance with NIH peer review procedures. The review will be conducted
by a multidisciplinary special emphasis panel. 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.

Since the intention of the R21 is to encourage development of new technologies
with the capability of stimulating new approaches to biomedical research or
leading to paradigm shifts, review criteria reflect this emphasis.

Review Criteria

The proposed project must have the potential for developing ground-breaking
technology or methodology that may lead to significant expansion of biomedical
research horizons, precipitate a paradigm shift in research, or lead to
substantial improvements in human health.

Other aspects of the proposed project that will be addressed by the initial
review group include:

The degree of innovation.  Does the project challenge existing paradigms or
develop new methodologies or technologies?

Impact.  Does the project have the potential for broad impact on biomedical
research?

Organization.  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?  Although preliminary data and biological hypotheses are not
required in R21 proposals, have the investigators made a plausible scientific
case for the project?

Ability of investigator(s) to carry out the proposed project.  Is the
investigator appropriately trained and well-suited to carry out this work?  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 budget.

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/or individual NIH institutes; and the availability of appropriated
funds.

INQUIRIES

Inquiries are encouraged early in the application development process.  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. Karl A. Koehler
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:  [email protected]

Direct inquiries regarding fiscal matters to:

Ms. Judith Musgrave
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: [email protected]

Applicants also may benefit from contacting staff of individual institutes early
in the application development process to determine interest and/or needs in
development of a particular technology/instrument/method.  Names and telephone
numbers of individuals are available electronically through the NIH Home Page
(www.nih.gov) as well as through individual institute home pages (www.institute
abbreviation.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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