DEVELOPMENT OF NONMAMMALIAN MODELS AND RELATED BIOLOGICAL MATERIALS FOR RESEARCH

Release Date:  June 17, 1999

PA NUMBER:  PAR-99-115 (Reissued as PA-06-498)

National Center for Research Resources

SOME APPLICATIONS UNDER THIS PA USE THE "MODULAR GRANT" AND "JUST-IN-TIME"
CONCEPTS.  THE PA INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION
INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO 
THIS PA.

This PA replaces PA-93-109, which was published in the NIH Guide, Vol. 22, No.
33, September 17, 1993.

PURPOSE

The Comparative Medicine area, National Center for Research Resources (NCRR)
is issuing this program announcement to encourage the submission of
applications for the development of nonmammalian models and associated
biological materials for biomedical research.  Models to be considered must be
applicable to the research interests of two or more categorical disease
institutes of the NIH.  The overall goal of these studies is to develop new
nonmammalian research models of broad interest and expand on the usefulness of
existing nonmammalian model systems.  Accordingly, the mechanisms for Research
Projects (R01), Exploratory/Developmental (R21) and Resource-Related Research
Projects (R24) grants 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, Development of Nonmammalian
Models and Related Biological Materials for Research, 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

Applications may be submitted by foreign and domestic, for-profit and non-
profit organizations, public and private, such as universities, college,
hospitals, laboratories, units of State or local governments, and eligible
agencies of the Federal government.  Racial/ethnic minority individuals,
women, and persons with disabilities are encouraged to apply as principal
investigators.

MECHANISM OF SUPPORT

The support mechanisms for this program will be the individual investigator-
initiated Research Project (R01), Exploratory/Developmental (R21) or Resource-
Related Research Projects (R24) grants, as applicable.  Under these
mechanisms, the applicant will plan, direct, and carry out the research
program.  The proposed project period during which the research will be
conducted should adequately reflect the time required to accomplish the stated
goals and be consistent with the policy for grant support.  Because the nature
and scope of the research proposed in response to the PA may vary, it is
anticipated that the size of an award will vary, as well.  However, because
the purpose of R21 grants is to help applicants acquire preliminary data for
use in preparing R01 or R24 applications, support for the R21 grants is
limited to two years with a maximum of $100,000 direct costs requested per
year.  In addition, for R01 and R24 applications, in accordance with NIH
policy, applicants planning to submit an investigator-initiated new (type 1),
competing continuation (type 2), competing supplement, or any amended/revised
version requesting $500,000 or more in direct costs for any year are advised
that they must contact Comparative Medicine, NCRR, program staff before
submitting the application, i.e., as plans for the study are being developed. 
Furthermore, the applicant must obtain agreement from staff that the NCRR will
accept the application for consideration for award.  Finally, the applicant
must identify, in a cover letter sent with the application, the staff member
at the NCRR who agreed to accept assignment of the application.  This policy
requires an applicant to obtain agreement for acceptance of both any such
application and any such subsequent amendment.  Refer to the NIH Guide for
Grants and Contracts, March 20, 1998 at
https://grants.nih.gov/grants/guide/notice-files/not98-030.html

Applications requesting $250,000 or less in direct costs should conform to
modular grant application procedures as outlined below under the section
APPLICATION PROCEDURES.

For applications requesting $250,000 or less in direct costs, specific
application instructions have been modified to reflect "MODULAR GRANT" and
"JUST-IN-TIME" streamlining efforts being examined by the NIH.  Complete and
detailed instructions and information on Modular Grants can be found at
https://grants.nih.gov/grants/funding/modular/modular.htm.

RESEARCH OBJECTIVES

Strength in biomedical research relates to the development of new model
systems and continued development of tools related to existing model systems
which make those models more useful or more widely applicable.  Some
biological characteristics may be revealed more readily in less complex, more
tractable species because of structural simplicity, especially at the genetic
or cellular levels.  The objective of this announcement is to stimulate
research on the development of nonmammalian models and related research
materials for biomedical research.

Examples of types of models which will be considered include nonmammalian
species such as fishes, amphibians, reptiles, invertebrates, and
microorganisms, and in vitro systems, such as cell lines (including embryonic
stem cells).

Preferred models are those which can be extensively studied from a number of
perspectives and which have the potential to provide well-understood
principles that can be described in detail in terms of genetics, biochemistry,
physiology, or other aspects.  For purposes of this PA, models must be of
interest to at least two categorical/disease Institutes of the National
Institutes of Health.  Research materials which are closely related to
nonmammalian models and which, when made available, will broaden the utility
of the models for research of interest to at least two categorical/disease
Institutes of the National Institutes of Health may be considered.  Examples
of such models and related materials of interest include, but are not limited
to:

o  viable, preserved germ cells
o  cell lines and cell culture models for nonmammalian animals where culture
systems are not well developed but would be widely used
o  collections of stocks of animals with transposable element insertions
o  collections of stocks of transgenic animals with Green Fluorescent Protein
fusions in the genome
o  efficient methods of gene knockout or targeted gene replacement in animals
o  research tools for proteome analysis

For R24 applications, the applicant must demonstrate a need for the resource
in the biomedical community.  This information should be included in the
Significance section of the application and, where appropriate, may include
letters of support from potential beneficiaries of the resource to be
developed.

It is recommended that potential applicants contact Comparative Medicine
program staff, as indicated below before submitting the application.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev.
4/98) and will be accepted at the standard application deadlines as indicated
in the application kit.  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].  Forms are on-line at
https://grants.nih.gov/grants/funding/phs398/phs398.html.

The program announcement title and number must be typed on line 2 of the face
page of the application form and the YES box must be marked.

Applications requesting $250,000 or less in direct costs per year should
conform to modular grant application procedures as announced in the NIH Guide,
December 15, 1998.  The modular grant concept establishes specific modules in
which direct costs may be requested as well as a maximum level for requested
budgets.  Only limited budgetary information is required under this approach. 
The just-in-time concept allows applicants to submit certain information only
when there is a possibility for an award.  It is anticipated that these
changes will reduce the administrative burden for the applicants, reviewers
and Institute staff.  Instructions for the PHS 398 form should be followed
except, for applications under modular grant procedures, the following special
instructions apply:

o  FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in
$25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total
Direct plus Facilities and Administrative (F&A) costs] for the initial budget
period.  Items 8a and 8b should be completed indicating the Direct and Total
Costs for the entire proposed period of support.

o  DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4
of the PHS 398.  It is not required and will not be accepted with the
application.

o  BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the
categorical budget table on Form Page 5 of the PHS 398.  It is not required
and will not be accepted with the application.

o  NARRATIVE BUDGET JUSTIFICATION - Use a Modular Grant Budget Narrative page.
(See https://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) 
At the top of the page, enter the total direct costs requested for each year.

o  Under Personnel, List key project personnel, including their names, percent
of effort, and roles on the project. No individual salary information should
be provided.

o  For Consortium/Contractual costs, provide an estimate of total costs
(direct plus facilities and administrative) for each year, each rounded to the
nearest $1,000.  List the individuals/organizations with whom consortium or
contractual arrangements have been made, the percent effort of key personnel,
and the role on the project.  Indicate whether the collaborating institution
is foreign or domestic.  The total cost for a consortium/ contractual
arrangement is included in the overall requested modular direct cost amount.

o  Provide an additional narrative budget justification for any variation in
the number of modules requested.

o  BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by
reviewers in the assessment of each individual"s qualifications for a specific
role in the proposed project, as well as to evaluate the overall
qualifications of the research team.  A biographical sketch is required for
all key personnel, following the instructions below. No more than three pages
may be used for each person.  A sample biographical sketch may be viewed at:
https://grants.nih.gov/grants/funding/modular/modular.htm

-Complete the educational block at the top of the form page,
-List position(s) and any honors
-Provide information, including overall goals and responsibilities, on
research projects ongoing or completed during the last three years.
-List selected peer-reviewed publications, with full citations,

o  CHECKLIST - This page should be completed and submitted with the
application.  If the F&A rate agreement has been established, indicate the
type of agreement and the date. It is important to identify all exclusions
that were used in the calculation of the F&A costs for the initial budget
period and all future budget years.

o  The applicant should provide the name and phone number of the individual to
contact concerning fiscal and administrative issues if additional information
is needed following the initial review.

Submit the signed, original, single-sided application, along with five exact,
single-sided copies and five collated sets of appendix materials 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 reviewed for completeness by the Center for Scientific
Review and for responsiveness to this program announcement by the NCRR staff. 
Incomplete and/or non-responsive applications will be returned to the
applicant without further consideration.  Applications that are complete and
responsive will be evaluated for scientific and technical merit by an
appropriate peer 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
one half of applications under review, will be discussed, assigned a priority
score, and receive a second level review by the National Advisory Research
Resources Council, NCRR.

Review Criteria for R01 and R24 Applications

The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.  In
the written comments, reviewers will be asked to discuss the following aspects
of the application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals.  Each of these
criteria will be addressed and considered in assigning the overall score,
weighting them as appropriate for each application.  Note that the application
does not need to be strong in all categories to be judged likely to have major
scientific impact and thus deserve a high priority score.  For example, an
investigator may propose to carry out important work that by its nature is not
innovative but is essential to move a field forward.

o  Significance:  Does this study address an important problem?  If the aims
of the application are achieved, how will scientific knowledge be advanced? 
What will be the effect of these studies on the concepts or methods that drive
this field?

o  Approach:  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  Innovation:  Does the project employ novel concepts, approaches or methods? 
Are the aims original and innovative?  Does the project challenge existing
paradigms or develop new methodologies or technologies?

o  Investigator:  Is the investigator appropriately trained and well suited to
carry out this work?  Is the work proposed appropriate to the experience level
of the principal investigator and other researchers (if any)?

o  Environment:  Does the scientific environment in which the work will be
done contribute to the probability of success?  Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements?  Is there evidence of institutional
support?

Review Criteria for R21 Applications

The review of R21 application will include the same criteria as applied to R01
and R24 applications.  However, this grant mechanism is designed to emphasize
exploratory/developmental research and to provide the opportunity to collect
sufficient preliminary data to demonstrate study feasibility in order to apply
for further support through other mechanisms.  Therefore, review of R21
applications will emphasize 1) the potential to provide a significant advance
in biomedical research and 2) the originality of the project.

All Applications:

In addition to the above criteria, in accordance with NIH policy, all
applications will be reviewed with respect to the following:

o  Appropriateness of the proposed budget and duration in relation to the
proposed research.

o  The adequacy of the proposed protection for humans, animals or the
environment, to the extent they may be adversely affected by the project
proposed in the application.

AWARD CRITERIA

Applications will compete for available funds with all other recommended
applications assigned to the NCRR.  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

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:

Michael C. Chang, Ph.D.
Division of Comparative Medicine
National Center for Research Resources
6705 Rockledge Drive, Room 6172
Bethesda, MD  20892
Telephone:  (301) 435-0744
FAX:  (301) 480-3819
E-mail:  [email protected]

Direct inquiries regarding fiscal matters to:

Ms. Irene Grissom
Office of Grants Management
National Center for Research Resources
6705 Rockledge Drive, Room 6212
Bethesda, MD  20892
Telephone:  (301) 435-0844
E-mail:  [email protected]

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.849.  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 NIH grants policies and Federal
Regulations 42 CFR 52 and 45 CFR Part 74 and 92.  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)