TECHNOLOGIES TO IMPROVE THE UTILITY OF ANIMAL MODELS

Release Date:  January 22, 1999

PA NUMBER:  PA-99-048

P.T.

National Center for Research Resources
National Cancer Institute
National Heart, Lung and Blood Institute
National Institute of Dental and Craniofacial Research
National Institute for Environmental Health Sciences

PURPOSE

This Program Announcement (PA) encourages the small business community to develop
technologies, reagents and equipment to improve the utility of animal models for
biomedical research.  The results of projects supported under this PA are
expected to be improvement of laboratory animal welfare, improved long-term
maintenance and preservation of laboratory animal models, and improved
technologies for generation of animal models of human diseases.

This PA must be read in conjunction with the OMNIBUS SOLICITATION OF THE PUBLIC
HEALTH SERVICE FOR SMALL BUSINESS INNOVATION RESEARCH GRANT (SBIR) APPLICATIONS
(PHS 98-2 or latest version) AND THE OMNIBUS SOLICITATION OF THE NATIONAL
INSTITUTES OF HEALTH FOR SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) GRANT
APPLICATIONS (PHS 98-3 or latest version).  All of the instructions within the
omnibus solicitation apply.

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, Technologies to Improve the
Utility of Animal Models, is related to several priority areas, including cancer,
heart disease and stroke, diabetes and chronic disability conditions, maternal
and infant health, and others.  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

Eligibility requirements are described in the OMNIBUS SOLICITATIONS.  Any small
business, independently owned by United States citizens and located in the United
States, may apply.

MECHANISM OF SUPPORT

Support for the PA is through the SBIR and STTR mechanisms, which are set-aside
programs.

Applications can be submitted for support as Phase I STTR (R41 mechanism) or
Phase I SBIR (R43 mechanism) grants, Phase II STTR (R42 mechanism) or Phase II
SBIR (R44 mechanism) grants, or under the SBIR/STTR FAST-TRACK option as
described in the OMNIBUS SOLICITATIONS.  Phase II applications in response to
this PA will only be accepted as competing continuations of previously funded NIH
Phase I SBIR/STTR awards.  The Phase II proposal must be a logical extension of
the Phase I research.

Information on the FAST-TRACK process and the OMNIBUS SOLICITATION are available
at:  http://www.nih.gov/grants/funding/sbir.htm  Unless otherwise noted, all PHS
grants policies apply.

RESEARCH OBJECTIVES

A large variety of animal models, both mammalian and nonmammalian, is currently
used in research to improve human health.  Cost-effective methods, reagents and
equipment to improve animal health and to characterize, culture and preserve
biomedically important organisms are critical needs for biomedical research. 
Reagents to diagnose and control laboratory animal diseases, including those of
aquatic animals, are needed.  Equipment and techniques for cost-effective
husbandry of animal models in controlled environments are needed for a variety
of aquatic and non-aquatic laboratory animals.  Furthermore, as new animal models
are developed for the study of human diseases, long-term culture methods and/or
germ-line preservation of these models becomes critical.  Improved technologies
for the cryopreservation of embryos and gametes are needed for several scientific
and economic reasons.  Projects supported under the PA are to be directed along
one or more of these objectives.

The National Center for Research Resources (NCRR) supports model systems that are
important to a broad base of research areas that include the research interests
of more than one NIH categorical or disease-based Institute or Center.  Projects
to meet the objectives stated above and that are to be accomplished for such
broadly-based animal models are appropriate to NCRR interests.  Further
information concerning NCRR interests can be accessed at the following URL: 
http://www.ncrr.nih.gov

The National Cancer Institute (NCI) is particularly interested in technologies
that support the development of pre-clinical models for cancer-related research. 
Information concerning the NCI"s interests are detailed at the following URL:
http://wwwosp.nci.nih.gov/bypass99/opportunities/index.html.  A number of the
planned activities that relate to models are the result of recommendations from
the NCI Director"s Pre-Clinical Models Working Group, which are found at the
following URL: 
http://deainfo.nci.nih.gov/ADVISORY/pog/directors/preclin_model/premod_rec.htm

The National Heart, Lung, and Blood Institute (NHLBI) has an interest in the
generation of new animal models of cardiovascular diseases, that more closely
recapitulate human cardiovascular diseases, in order to investigate the molecular
mechanisms underlying normal and abnormal development, physiology, and
pathophysiology of the cardiovascular system.  In addition, the development of
new methods to measure essential cardiovascular performance parameters, such as
heart wall motion and coronary blood flow, especially in small animal models such
as mice, is desired.  Further information concerning NHLBI interests can be
accessed at the NHLBI web site.

The National Institute of Dental and Craniofacial Research (NIDCR) is
particularly interested in the development of new animal models that address the
etiology, pathogenesis, prevention, diagnosis and treatment of oral, craniofacial
and dental diseases and conditions. Some examples include but are not limited to:

o  Development of animal models possessing specific genetic craniofacial
anomalies for use in studies on the etiology of disease, gene regulation,
gene/environment analysis, and gene-product function and development of treatment
protocols.

o  Development of improved animal or in vitro models of oral infectious diseases
to enable evaluation of pathogenesis and therapies.

o  Development of animal models of localized and metastatic oral squamous cell
carcinomas.

o  Development of improved in vitro or animal models for evaluating biomechanical 
wear or systemic responses associated with TMJ devices or engineered tissues.

o  Development of animal models for assessing pathobiological changes in the TMJ
or masticatory muscles, improved biochemical markers of joint degradation.
Additional information concerning NIDCR interests can be accessed at the
following URL: http://www.nidcr.nih.gov.

The National Institute for Environmental Health Sciences (NIEHS) is the lead NIH
Institute for the development of alternative designs/methods for
toxicity/carcinogenicity assessment.  As such, NIEHS is committed to providing
support for the development of innovative services or products that are
responsive to this goal.  Companies should address in an application their
approach for the regulatory acceptance of a new or revised test and the impact
it would have on the prediction of human and ecological effects of environmental
agents.  The NIEHS is particularly interested in mechanism-based approaches that
may improve toxicity characterization, increase savings in time and cost, or
otherwise improve the utilization of animals.  Some of the methods/services that
have been identified include but are not limited to the following.

o  Alternative designs of the standard cancer bioassay to make the end results
more amenable to low-dose extrapolation and risk estimation.

o  Laboratory or clinical tests that aid in the detection and measurement of
toxicity from chemical exposure at levels which do not produce acute symptoms but
which may produce detectable damage years later.

o  Development of toxicological methods which use alternative species such as non
mammals or invertebrates, which reduce the number of animals required, or which
refine a procedure in such a way as to eliminate or minimize pain or distress in
animals.

o  Development of methods or procedures which better predict the toxicity of
environmental pollutants on humans particularly reproductive, developmental and
neural effects.

o  Development of transgenic animal approaches for predicting toxicity.

Additional information concerning the NIEHS interests can be accessed at the
following URL:  http://www.niehs.nih.gov/

APPLICATION PROCEDURES

OMNIBUS SOLICITATIONS for both the SBIR and STTR programs are available
electronically through the NIH Office of Extramural Research "Small Business
Funding Opportunities" web site:  http://www.nih.gov/grants/funding/sbir.htm. 
Hard copies may be obtained from the PHS SBIR/STTR Solicitation Office, phone
(301) 206-9385, subject to availability.  Information for preparation of the
application can be obtained at: 
http://www.nih.gov/grants/funding/sbirsttradvice.htm.

Applications in response to the PA are to be submitted on the grant application
form PHS 6246-1 for SBIR Phase I, PHS 6246-3 for STTR Phase I, PHS 6246-2 (latest
revision) for SBIR Phase II, and PHS 6246-4 for STTR Phase II.  The application
forms can be found at the Small Business Funding Opportunities web site at
http://www.nih.gov/grants/funding/sbir.htm.  Phase I applications are provided
as part of the OMNIBUS SOLICITATIONS both at the web site, and in hard copy.  The
title and number of this PA must be typed on line 2 of the face page of the
application for Phase I SBIR and STTR applications.

Beginning with the April 15, 1999 receipt date, applications are to follow
Modular Grant Application and Award procedures, as outlined in the OMNIBUS
SOLICITATIONS for SBIR and STTR grants.

Potential applicants are encouraged to contact program staff for guidance,
however the responsibility for planning, direction and execution of the proposed
research will be solely that of the applicant.  Application instructions
specified in the OMNIBUS SOLICITATIONS for each mechanism must be followed.  A
model Phase I application can be viewed at
http://www.nhlbi.nih.gov/nhlbi/sbir/modelsbi.htm

The normal award for Phase I SBIR is six months and $100,000 for directs costs,
indirect costs and fixed fee.  The normal award for Phase II SBIR is for two
years and $750,000.  For STTR, the normal award for Phase I is for one year and
$100,000, for Phase II it is two years and $500,000.  As stated in the OMNIBUS
SOLICITATIONS, these are guidelines, and applicants may propose longer periods
of time or larger amounts of funding.  However, applicants who plan to submit
applications requesting $500,000 or more per year are advised that it is
important to contact program staff listed in the OMNIBUS SOLICITATIONS prior to
submitting the application (see NIH GUIDE FOR GRANTS AND CONTRACTS, March 20,
1998, accessed through http://www.nih.gov/grants/guide/).

Phase I applications must specify clear, measurable goals that should be achieved
prior to Phase II funding.

The completed original application and two exact, single sided copies must be
sent or delivered 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)

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS referral
guidelines.  Upon receipt, applications will be reviewed for completeness by the
NIH Center for Scientific Review.  Incomplete applications will be returned to
the applicant without further consideration.

Applications will be reviewed for scientific and technical merit by an initial
review group convened by the Center for Scientific Review, in accordance with the
standard NIH peer review procedures.  As part of the initial merit review, all
applications will receive a written critique and undergo a process in which only
those applications deemed to have the highest scientific merit will be discussed
and assigned a priority score.

Review Criteria

Review criteria are as described in the OMNIBUS SOLICITATIONS:

o  The soundness and technical merit of the proposed approach.  (Preliminary data
are not required for Phase I proposals).

o  The qualifications of the proposed Principal Investigator, supporting staff,
and consultants.

o  The scientific, technical, or technological innovation of the proposed
research.

o  The potential of the proposed research for commercial application or societal
impact.

o  The adequacy and suitability of the facilities and research environment.

In addition to the above criteria, in accordance with NIH policy, all
applications will be reviewed with respect to the appropriateness of the proposed
budget and duration in relation to the proposed project.  Where applicable, the
adequacy of assurances detailing the proposed means for (a) safeguarding human
or animal subjects and/or (b) protecting against or minimizing any adverse effect
on the environment will be evaluated.

The goals specified in the Phase I application should be achieved prior to
initiating Phase II.  Failure to provide clear, measurable goals in Phase I may
be sufficient reason for the initial review group to judge the application non-
competitive.

AWARD CRITERIA

Applications will compete for available funds with all other  SBIR and STTR
applications assigned to the awarding Institute or Center.  The following will
be considered when making funding decisions:

o  Quality of the proposed project as determined by peer review
o  Availability of funds
o  Program balance among research areas of the announcement

FAST-TRACK, Phase II applications may be funded following submission of the Phase
I progress report and other documents necessary for continuation.  Phase II
applications will be selected or funding based on the initial priority score, the
awarding Institute or Center"s assessment of the Phase I progress and
determination that Phase I goals were achieved, the project"s potential for
commercial success, and the availability of funds.

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:

Director, Comparative Medicine
National Center for Research Resources
6705 Rockledge Drive, Room 5158
Bethesda, MD   20892
Telephone: (301) 435-0744
FAX:  (301) 480-3819
Email:  johns@ncrr.nih.gov

Jo Anne Goodnight
Division of Cancer Biology
National Cancer Institute
Executive Plaza North, Room 500
Bethesda, MD   20892-7380
Telephone:  (301) 496-5307
FAX:  (301) 496-8656
Email:  jg128w@nih.gov

Christine A. Kelley, Ph.D.
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
Two Rockledge Center, Suite 10193
Bethesda, MD  20892-7956
Telephone:  (301) 435-0565
FAX:  (301) 480-2849
Email:  ck53r@nih.gov

Joyce A. Reese, D.D.S., M.P.H.
Division of Extramural Research
National Institute of Dental and Craniofacial Research
Building 45, Room 4AN-24K
Bethesda, MD  20892-6402
Telephone:  (301) 594-2088
FAX:  (301) 480-8318
Email:  Joyce.Reese@nih.gov

Michael J. Galvin Jr., Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, EC-23
111 T.W. Alexander Drive, EC-23 (for express/courier service)
Research Triangle Park, NC  27709
Telephone:  (910) 541-7825
FAX:  (919) 541-5064
Email:  galvin@niehs.nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Joellen Harper
Office of Grants Management
National Center for Research Resources
6705 Rockledge Drive, Room 6086
Bethesda, MD  20892
Telephone:  (301) 435-0844
FAX:  (301) 480-3777
Email:  jh41m@nih.gov

Kathleen J. Shino
Grants Management Branch
National Cancer Institute
6120 Executive Boulevard, Room 243
Bethesda, MD  20982-7150
Telephone:  (301) 496-7800 ext 248
FAX:  (301) 496-8601
Email:  shinok@gab.nci.nih.gov

Mr. Bruce Butrum
Grants Operations Branch
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7142
Bethesda, MD   20892-7128
Telephone:  (301) 435-0177
FAX:  (301) 480-0422
Email:  butrumb@gwgate.nhlbi.nih.gov

Mr. Daniel Milstead
Division of Extramural Research
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN-44K, MSC 6402
Bethesda, MD  20892-6402
Telephone:  (301) 594-4800
FAX:  (301) 480-8301
Email:  Daniel.Milstead@nih.gov

Mr. David L. Mineo
Chief, Grants Management Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD 2-01
104 T.W. Alexander Drive
Building 2, Room 203B
Research Triangle Park, NC  27709
Telephone:  (919) 541-7628
FAX:  (919) 541-2860
Email:  mineo@niehs.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.849 (NCRR), 93.396 (NCI), 93.837 (NHLBI), 93.113, 93.115 (NIEHS), and 93.121
(NIDCD).  Awards are made under authorization of the Public Health Service Act,
Title IV, 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 and 45 CFR Part 74.  This program is not subject to the intergovernmental
review requirement 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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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