LARGE-SCALE COLLABORATIVE PROJECT AWARDS

Release Date:  May 26, 1999

RFA:  GM-99-007

National Institute of General Medical Sciences

Public Briefing Date:  July 12, 1999
Phase I Application Receipt Date:  August 27, 1999
Phase II Application Receipt Date: January 21, 2000

PURPOSE

The purpose of this request for applications is to enable the solution of
major problems in biomedical research and to facilitate the next evolutionary
stage of integrative biomedical science.  The intention is to make resources
available for independently funded scientists to form research teams to solve
a complex biological problem that would be beyond the means of any one
research group, and that is of central importance to biomedical science and to
the mission of the National Institute of General Medical Sciences (NIGMS).  It
is expected that the participating investigators will already hold externally
peer reviewed and funded research grants in the area of the proposal, and in
general, support of new individual research projects will not be a part of
these large scale project awards.  A high level of resources may be requested
to allow participating investigators to extend their research efforts to form
a consortium to approach a research problem of overarching importance in a
comprehensive and highly integrated fashion.

Grants for this initiative will be awarded in two phases.  The purpose of the
Phase I award is to provide resources for detailed planning to applicants who
have demonstrated the selection of an appropriate complex biological problem,
an innovative plan, and appropriate commitments to its solution from
participating investigators and institutions.  Phase I applicants will submit
an overview of the proposed large scale project for peer review.  Successful
Phase I applicants will receive a $25,000 (direct costs) planning grant, and
those applicants who receive awards will be eligible to submit a more
extensively planned and detailed application for a Phase II award to support
the large scale project itself.

This RFA is one of a pair of new initiatives to increase support opportunities
for collaborative ventures.  A companion program announcement, "Integrative
and Collaborative Approaches to Research," will be published shortly in the
NIH Guide; it is intended to support collaborative activities that are smaller
in scale and scope than those requested in response to this RFA.  The NIGMS
also advises that collaborations can be supported by most of the Institute's
existing support mechanisms and strongly encourages potential applicants to
talk with program directors in NIGMS to determine the most appropriate support
mechanism for their collaborative work.

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 Request for Applications (RFA),
Large Scale Collaborative Projects, is related to one or more of the priority
areas.  Potential applicants may obtain a copy of "Healthy People 2000" at
http://www.crisny.org/health/us/health7.html.

ELIGIBILITY REQUIREMENTS

Applications must fall directly into the areas of research supported by the
National Institute of General Medical Sciences.  Applicants are advised to
visit the Institute website at http://www.nih.gov/nigms for information on
NIGMS areas of interest. The projects must support the NIGMS mission as
detailed in the publication, "Divisions and Grant Award Mechanisms," available
from the NIGMS Public Information Office (301/496-7301).  Potential applicants
may wish to visit the NIGMS website created for this RFA and the PA referred
to above at http://www.nih.gov/nigms/funding/gluegrants.html . Applicants are
also strongly advised to contact the NIGMS staff listed below to discuss the
eligibility of a proposed project.

The major research activity of the principal investigator must be in the
research area of the collaborative project application, and the principal
investigator is expected to make a major commitment of effort to directing and
managing the operation of the project; a substantial level of effort will be
necessary to manage a project of this magnitude. NIGMS anticipates that each
collaborative project will include a substantial number of participating
investigators.  For example, a modest size large scale collaborative project
might contain fifteen or more participating investigators, who in the
aggregate, hold independent peer-reviewed grants in the proposed research area
in excess of  $2.0 million (annual direct costs) at the time of application,
and who will be actively involved in and committed to the goals of the
consortium.  However, minimum and maximum numbers of participating
investigators have not been set.

Applications may be submitted by domestic, non-profit organizations, public
and private, such as universities, colleges, hospitals, laboratories, units of
State and local governments, and eligible agencies of the Federal government.

Multi-institutional applications are encouraged.  A collaborative project may
include participating investigators from foreign and/or for-profit
organizations.  Participation by industry is also encouraged as appropriate. 
Racial/ethnic minority individuals, women, and persons with disabilities are
encouraged to apply as Principal Investigators.

MECHANISM OF SUPPORT

Phase I Applications

For Phase I applications, this RFA will use the National Institutes of Health
(NIH) R24 grant mechanism.  A Phase I award will be made for three months at a
level of $25,000 in direct costs to provide for costs associated with planning
the large scale collaborative project.  Appropriate expenses for a planning
award include, but are not limited to, salary for release time for the
principal investigator to commit a significant percentage of effort to
planning the Phase II application, meetings of the steering committee and
participating investigators, and consultant costs for initial design and cost
estimates for proposed core resources.  The anticipated award date for Phase I
awards is November 1, 1999.

Phase II Applications

Only applicants who receive a Phase I award will be eligible to submit a Phase
II application, which will be a new (Type 1) award.  For Phase II
applications, this RFA will use the NIH Specialized Center (Cooperative
Agreements) mechanism, U54.  The total project period for an application
submitted in response to this RFA may not exceed five years. The anticipated
award date for Phase II awards is September 2000.  Phase II awards will be
considered for one five-year renewal period following the initial award.

Funding for Phase II applications will be provided by means of cooperative
agreements.  A cooperative agreement is an "assistance" mechanism in which
substantial NIH scientific and/or programmatic involvement with the awardee is
anticipated during the performance of the activities conducted by the awardee. 
Under a cooperative agreement, the NIH purpose is to support, stimulate, and
expedite the recipients' activities by jointly being involved with them. NIGMS
staff will work cooperatively with the award recipients in a partner role, but
will not assume direction, prime responsibility, or a dominant role in the
activity.  Details of the responsibilities, relationships, and governance of
the activities to be funded under the cooperative agreements awarded for this
Program are discussed later in this document under the section "Terms and
Conditions."

This RFA is a one-time solicitation, although NIGMS presently anticipates re-
announcing the solicitation, depending on the availability of funds.  Both new
and revised Phase I applications, and revised applications for unsuccessful
Phase II proposals, would be accepted if the solicitation is re-announced
within a two-year period;

FUNDS AVAILABLE

NIGMS intends to commit up to $20 million in total costs in FY2000 to fund
both Phase I and Phase II awards.  NIGMS anticipates funding up to ten Phase I
awards; each Phase I award will be for $25,000 in direct costs. Up to five
Phase II grants will be awarded.  Because the nature and scope of the proposed
research will vary, it is anticipated that the size of the Phase II awards
also will vary, and the upper limit for a Phase II award will be $5 million
per year in annual direct costs.

RESEARCH GOALS, SCOPE, AND ORGANIZATION

Background:

NIGMS' external advisors, who met in May and November 1998, urged the
Institute to support new mechanisms for collaboration on complex systems in
biomedical science.  For most of the last thirty years the main approach used
in biomedical science has been to focus attention on understanding the
individual steps in biological processes at the subcellular and molecular
level. Although much still needs to be done in defining and analyzing
molecular events, it appears that enough of the pieces have been characterized
to begin to put them together to solve problems of the global control and
integration of biological processes.  These efforts will require the
cooperation of many groups of scientists and many types of science.

The mainstay for support of biomedical science has been the traditional
research project grant, the NIH R01 grant.  While this grant mechanism remains
the backbone of NIH support for biomedical science, it may not be sufficient
in and of itself to support the solution of complex problems of the type
described above.  Many scientists are now expressing a strong need for a new
type of support that will encourage scientific collaboration and provide for a
higher level of coordination to solve problems requiring multifaceted
approaches.  These scientists are able to secure research support for their
own efforts but seek a means to encourage and facilitate the development of an
interactive research network around a complex biological problem.

The purpose of this request for applications is to address the need to
coalesce and coordinate efforts on a larger central problem in biomedical
science and to make collaborations and resources available to a group of
independently funded investigators.  Biomedical science has entered a new era
where these collaborations are becoming critical to rapid progress.  This is
the result of several factors. First, not every laboratory has the breadth to
pursue problems which increasingly must be solved through the application of a
multitude of approaches.  These include the involvement of fields, such as
physics, engineering, mathematics, and computer science, that were previously
considered peripheral to mainstream biomedical science.  Second, the ability
to attack large projects that involve considerable data collection and
technology development require the collaboration of many groups and
laboratories.  Finally, large-scale, expensive technologies such as
combinatorial chemistry, DNA chips, high throughput mass spectrometric
analysis, etc., are not readily available to all laboratories that could
benefit from their use.  These technologies require specialized expertise, but
could lend themselves to management by specialists who collaborate or offer
services to others.

Research Objectives:

The primary research objectives are to solve complex biological problems of
great significance through large scale collaborative projects that integrate
broad and diverse areas of science by bringing together independently funded
investigators who share a connection to a central problem and to facilitate
the development of integrative biomedical science.  The intention is to
provide the framework and incentives to foster the development of integrative
research teams and to provide considerable flexibility for participants to
request and employ the specific resources necessary to accomplish the job. 
Part of the challenge of each large scale collaborative project will be to
devise the organizational structure that best facilitates accomplishment of
the specific scientific goals of that collaborative project.  The main outcome
expected is the solution of a complex, multifaceted research problem of
overarching significance, where such a solution could not be achieved in a
reasonable time frame by separate efforts. An additional expected outcome is
that collaboration and integration in the biomedical sciences will be
enhanced.

The research scope for this RFA includes all areas of science that are of
direct relevance to the National Institute of General Medical Sciences
(http://www.nih.gov/nigms/about_nigms/overview.html). Participation by
investigators doing mechanistic clinical science is welcomed as well as by
investigators doing basic laboratory science.  It is recognized that data
collection and technology development may be logical and necessary parts for
some or all large scale collaborative projects.

Possible examples of scientific problems that could be addressed by large-
scale collaborative teams might be:

working out all facets of particular cellular processes, both for the process
itself and for its integration into and control of cellular function

determining structures and distilling global structure-function principles for
organelles

quantitatively modeling interacting metabolic pathways in a model organism

determining the multi-level control mechanisms and their integration into the
biological response to traumatic injury

Whether projects such as these illustrative examples are sufficiently
important to be funded as large scale collaborative project awards will be
determined by peer review and relevance to current areas of interest to the
Institute.

It will not be sufficient to organize a research network simply to promote
access of individual investigators to research resources.  There must be
intense and meaningful interaction proposed around a central biological
problem among the participating scientists, so that progress achieved is
substantially greater than the sum of the participants' individual
achievements.  Each large scale collaborative project, as in the examples
above, could require considerable new resources, but would also require a
synthesis of information from individual laboratories in order to solve the
biological problem being addressed.

The Phase I application should provide an overview of the proposed
collaborative project, including the goals for the project, the reasons for
using this mechanism, and the approach to the expected elements of a Phase II
proposal.

The Phase II application should provide a more detailed explanation of the
proposed project, including specific intermediate goals (milestones) and a
timeline for their accomplishment.

Elements of a Large-Scale Collaborative Project:

PRINCIPAL INVESTIGATOR:  Each collaborative project will be headed by a
principal investigator (PI) who will chair and be assisted in governing the
project by a steering committee. Although a substantial level of effort is
expected for the PI, minimum levels of effort have not been set for the PI;
however, the level of effort of the PI will be a factor in the assessment of
scientific merit and in the Institute's funding selections.

STEERING COMMITTEE:  The steering committee is responsible for governance of
the large scale collaborative project, and its membership, chosen from
participating investigators and project staff, should be representative of the
scope and membership of the proposed collaborative project.  The level of
effort and commitment to the collaborative project of the members of the
steering committee will also factor into the assessment of scientific merit as
well as the Institute's funding selections.  It is expected that the principal
investigator, the steering committee, and the participating investigators will
work together to develop reasonable and sound goals and operating procedures
for the collaborative project.  An NIGMS program director will serve as a
member of the steering committee and attend its meetings.

PARTICIPATING INVESTIGATORS:  In addition to the PI and members of the
steering committee, each collaborative project will include a team of
investigators who will contribute to and benefit from participation in the
project.  The members of the collaborative project will be referred to
collectively as participating investigators.  It is expected that each of the
participating investigators will hold an externally peer reviewed and funded
research grant in the area of the project.  It is expected that the majority
will be funded through regular research grants supported by NIGMS, other NIH
institutes and centers, and other governmental and private agencies. 
Exceptions to the rule of external funding may include participating
investigators from industry, foreign institutions or allied fields not
traditionally supported by the NIH (e.g., physics and mathematics). However,
they must provide evidence of their commitment to the project and a listing of
organizational resources that will be committed to the project.  Principal
investigators of pilot projects (see below under COLLABORATIVE PROJECT
RESOURCES) will also be considered participating investigators.  Participating
investigators will work with the other members of the team to develop workable
guidelines for the collaborative project.  Participating investigators must
agree to abide by the policies and rules set up for the collaborative project
and to the terms and conditions herein to be eligible to participate.  During
the period of the award, a participating investigator whose independent
research support terminates may continue as a participating investigator at
the discretion of the steering committee and with the approval of the NIGMS
program director.  However, funds from this award are not to be used to
support the independent project of such an investigator.  It is expected that
new participating investigators will be added to the collaborative project
over the period of the award as deemed appropriate by the principal
investigator and steering committee and with the approval of the NIGMS program
director; these additions will be reported in the annual progress report.

ADVISORY COMMITTEE:  Each large-scale collaborative project will include an
external advisory committee whose purpose is to meet annually with the
principal investigator and the steering committee to assess progress and
provide feedback on proposed goals for the next year of support.  The members
will be appointed by the principal investigator in consultation with the
steering committee and with the approval of the NIGMS program director, after
the Phase II award has been made, and will be drawn from research scientists
not involved in the project. The members of the advisory committee should not
be selected until an award has been made.  The NIGMS program director
responsible for the award will attend the meeting of the advisory committee as
a member of the steering committee, but will not be a member of the advisory
committee.  The advisory committee will meet at least once a year immediately
prior to the submission of the annual progress report.

COLLABORATIVE PROJECT RESOURCES:  The organizational structure of the
collaborative project may have a variety of forms depending on the needs of
the research problem being addressed.  For example, the large scale
collaborative project could consist entirely of a research and administrative
structure, including a data coordinating and information dissemination center,
independent of supporting additional activities in any of the laboratories of
the participating investigators.  In addition, the large-scale collaborative
project may request the following types of resources:

Bridging projects may be requested for collaboration enhancement activities
(essentially supplements to the ongoing independent work) in the laboratories
of the participating investigators. These bridging projects to the
laboratories of participating investigators are to add to or bridge the
intellectual and technological approaches of the collaborative project.  They
are not meant to be stand-alone research efforts but are to be subprojects
that tie (or enhance the contribution of) the independent work of the
participating investigator to the large scale collaborative project.

Pilot projects may be requested for investigators without current independent
support in the area of the collaborative project to add elements where gaps
exist, or to add investigators with critical knowledge or expertise but
without a research background in the area of the collaborative project.  These
pilot projects must not exceed $75,000 in annual direct costs and must be
limited to no more than three pilot projects per large-scale collaborative
project. The pilot project should be of sufficient scope to qualify as a stand
alone research effort.  It is primarily intended to allow the collaborative
project to add investigators outside the scientific mainstream of the project
area in a mode that will allow them to develop independent research in the
area of the collaborative project. While funding for a pilot project may run
for five years, at the discretion of the steering committee, it is expected
that the principal investigator of a pilot project will seek R01 funding
during the period of the collaborative project, based on the results obtained
from the pilot project.

Core resources may be requested to speed progress on the scientific goals of
the project or add additional capability to the collaborative project by
adding new or improved technology or by standardizing data among different
research teams.  An example of new technology might be  gene chip microarray
technology; an example of standardizing results might be establishment of a
model organism core.  It is expected that each large-scale collaborative
project will request core resources for information collection, coordination,
and dissemination.  Other types of resources might be for instrumentation,
genomics, proteomics, high-throughput assays, or
computational/bioinformatics/modeling cores.  Requests for core resources must
be strongly justified in terms of value to achieving the goals of the project,
value to increasing the synergy of the collaborative project, and cost
effectiveness.

ADMINISTRATIVE MANAGEMENT PLAN:  Each large-scale collaborative project award
must include an administrative management plan that outlines the policies and
procedures for access of participating and non-participating investigators to
the collaborative project resources.  The application should address the flow
of information within the project, and plans for how the information will be
integrated into the solution of the biological problem being addressed. The
mechanism to add new participating investigators and delete members whose
association with the project has not been productive should be documented in
the proposal.  The plan should also include proposed methods for information
dissemination both within the collaborative project and to the scientific
community.  Furthermore, each large-scale collaborative project will include a
mechanism to consider and respond to concerns of the scientific community
directly affected by the project about the operation and impact of the
project. A discussion of scientific community views will be part of the agenda
for annual meetings of the steering committee with the advisory committee.

PROJECT MANAGEMENT PLAN:  Each large scale-collaborative project application
must include a project management plan, including an ongoing evaluation plan,
to ensure consistent forward progress of the project.  Each collaborative
project will define, at a minimum, yearly milestones, and those receiving
awards will have the opportunity to modify these milestones at the time of
their awards, with the concurrence of NIGMS.  It is expected that the
milestones will be adjusted annually at the award anniversary dates, both to
incorporate a team's scientific accomplishments and progress in the field in
general, as well as to reflect the recommendations of the advisory committee.
The NIGMS program director responsible for the large-scale collaborative
project may include outside consultants in the annual progress review and may
recommend reducing or withholding funds, or termination of the award, for
failure to meet milestones. A report by the NIGMS program director of each
collaborative project's progress and any recommendations to modify funding
will be made annually to the National Advisory General Medical Sciences
Council.

PLAN FOR DATA SHARING AND INTELLECTUAL PROPERTY:  To address the interests of
the government in the availability of, and access to, the results of publicly
funded research, NIH requires applicants who respond to this RFA to develop
and propose specific plans for sharing the data and materials generated
through the large-scale collaborative project.  The initial review group will
comment on the proposed plans. The adequacy of the plans will also be
considered by NIH staff as one of the criteria for award.  Because
dissemination is a critical aspect and fundamental purpose of this RFA, the
proposed sharing and data release plans, after negotiation with the applicant
when necessary, will be made a condition of the award. Evaluation of renewal
applications will include assessment of the effectiveness of data and material
release.  It is further suggested that the members of the large-scale
collaborative project disclose to the steering committee their ties to profit-
making organizations to aid the project in avoiding conflict of interest
situations. Applicants are also reminded that the grantee institution is
required to disclose each subject invention to the Federal Agency providing
research funds within two months after the inventor discloses it in writing to
grantee institution personnel responsible for patent matters.

SPECIAL REQUIREMENTS FOR COOPERATIVE AGREEMENTS

Terms and Conditions of Award

The following Terms and Conditions will be incorporated into the award
statement and will be provided to the Principal Investigator as well as to the
appropriate institutional official, at the time of award.  The following
special terms of award are in addition to, and not in lieu of, otherwise
applicable OMB administrative guidelines, HHS grant administration regulations
at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local
Governments are eligible to apply), and other HHS, PHS, and NIH grant
administration policies:

The administrative and funding instrument used for this program will be the
cooperative agreement, an "assistance" mechanism (rather than an "acquisition"
mechanism), in which substantial NIH programmatic involvement with the
awardees is anticipated during performance of the activities.  Under the
cooperative agreement, the NIH purpose is to support and stimulate the
recipients' activities by involvement in and otherwise working jointly with
the award recipients in a partnership role; it is not to assume direction,
prime responsibility, or a dominant role in the activities.  Consistent with
this concept, the dominant role and prime responsibility resides with the
awardees for the project as a whole.

Awardees will retain custody of and have primary rights to the data developed
under these awards, subject to Government rights of access consistent with
current HHS, PHS, and NIH policies.  Awardees should comply with their
institutional intellectual property policies and practices as approved in the
award.  However, awardees will be expected to share (make available) this data
openly with the scientific community.

Principal Investigator Responsibilities:

The principal investigator is the scientist who assembles the large scale
collaborative project and is responsible for submitting the application in
response to this RFA and for performance of the project.  The PI will
coordinate project activities scientifically and administratively at the
awardee institution.  The PI will have the overall responsibility for the
scientific and technical direction and the administration and overall
operation of the large scale collaborative project.  To assist the PI with the
governing of the project, a steering committee will be established from among
the participating investigators and project staff.  The principal investigator
will chair the steering committee. The membership will be representative of
the scope of the project. As for all participating investigators, the PI must
abide by the operating rules and guidelines developed by the steering
committee.  The Principal Investigator will agree to accept participation of
NIGMS staff in those aspects of management of the project described under
"NIGMS Program Director Responsibilities".  He/she will also ensure the timely
dissemination of information generated by the large-scale collaborative
project to both the project members and the scientific public.

Participating Investigator Responsibilities:

The participating investigators are those scientists holding externally peer
reviewed grant support in the area of the project and who are involved with
and committed to the goals of the project. Exceptions to the rule of external
funding may include participating investigators from industry, foreign
institutions or allied fields not traditionally supported by the NIH (e.g.,
physics and mathematics); PIs of pilot project are also included. 
Participating investigators will work with the principal investigator, the
steering committee, and the other members of the large scale collaborative
project to set goals and develop working procedures; they must agree to
support the goals of the project and to abide by the operating guidelines and
procedures established for the project.  Participating investigators will be
actively involved project and interactive with the other members of the
project.

NIGMS Program Director Responsibilities:

The NIGMS program director will serve as a voting member of the steering
committee and will attend all meetings.  In addition to having all of the
duties and responsibilities of a steering committee member, the NIGMS program
director will facilitate interactions among the steering committee and the
advisory committee and NIGMS and provide advice and guidance to assure that
the large scale-collaborative project adheres to the NIH and NIGMS rules and
regulations.  The NIGMS program director will facilitate communication with
the scientific community directly affected by the collaborative project and
will assure that the steering committee and the advisory committee address
issues and concerns raised by the community.  Additional responsibilities may
be negotiated at the time of award depending on the individual characteristics
of the awards to be made.

Steering Committee Responsibilities

A steering committee will serve as the governing board of each large scale
collaborative project and will participate in setting direction, policies and
operating procedures.  Membership will include the principal investigator, as
well as other scientists and administrators drawn from the staff and
participating investigators of the project, sufficient in breadth and balance
to be representative of the overall project.  The NIGMS program director will
serve as a member of the steering committee.  The original members will be
selected by the principal investigator from among the participating
investigators and staff to be representative of the scope of the project. 
Additional or replacement members will be selected by the steering committee. 
The steering committee will work with the principal investigator to establish
the scientific and technical direction of the project, develop common
guidelines and procedures, establish rules for access to resources of the
project and for dealing with intellectual property issues, and participate in
the process of developing a cohesive group.  The steering committee will
develop a policy regarding disclosure of ties between scientists and profit-
making organizations to aid the project in avoiding conflict of interest
situations. The steering committee will monitor bridging projects, core
resources, and pilot projects for progress and efficiency, and recommend
modification of support and addition/deletion of these activities as needed to
facilitate progress on the goals of the large-scale collaborative project.

Advisory Committee Responsibilities:

The advisory committee will be composed of a panel of a minimum of three
scientists not otherwise associated with the large scale collaborative project
or affiliated with any of the participating institutions.  The NIGMS program
director will attend the meetings of the advisory committee as a member of the
steering committee.  The advisory committee will meet at least yearly to
advise the steering committee of the large scale collaborative project in
meeting its goals and to comment on plans for future directions.  The advisory
committee will raise issues for consideration by the principal investigator
and the steering committee and will comment on the appropriateness of the
level of NIGMS support to achieve the goals of the project. The advisory
committee will also comment on the impact of the collaborative project on the
relevant scientific communities.

Milestones and Evaluations

It is expected that milestones will be adjusted annually at the award
anniversary dates, both to incorporate a group's scientific accomplishments
and progress in the field in general, as well as to reflect the
recommendations of the advisory committee.  In accordance with the procedure
described above, the NIGMS program director may recommend to the Director,
NIGMS, augmenting any subproject or core facility, or reducing or withholding
funds for any subproject or core facility that substantially fails to meet its
milestones or to remain state-of-the-art.

The Director, NIGMS, retains the right to call a meeting of advisors, most
likely members of the National Advisory General Medical Sciences Council or
their designee(s), at any time to provide advice on the scientific progress of
a large-scale collaborative project.  It is anticipated that such a group of
advisors may want to attend a meeting of the project advisory committee as
part of its fact-finding mission.

Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within
the scope of the award) between award recipients and the NIGMS may be brought
to arbitration.  An arbitration panel will be convened.  It will be composed
of three members: a designee of the principal investigator, one NIGMS
designee, and a third designee with expertise in the relevant area who is
chosen by the other two; in the case of an individual disagreement, the first
member may be chosen by the individual awardee.  This special arbitration
procedure in no way affects the awardee's right to appeal an adverse action
that is otherwise appealable in accordance with PHS regulations 42 CFR Part
50, Subpart D and HHS regulation at 45 CFR Part 16.

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 is 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 was published in the Federal Register of March 28, 1994 (FR
59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No.
11, March 18, 1994, available on the web at:
https://grants.nih.gov/grants/guide/notice-files/not94-100.html.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research conducted or supported by the
NIH, unless there are scientific and ethical reasons not to include them. 
This policy applies to all initial (Type 1) applications submitted for receipt
dates after October 1, 1998.

All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the Inclusion of Children as Participants in
Research Involving Human Subjects that was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address:
https://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators also may obtain copies of these policies from the program staff
listed under INQUIRIES.  Program staff may also provide additional relevant
information concerning the policy.

PUBLIC BRIEFING

Prospective applicants are invited to attend a public briefing on large-scale
collaborative project awards on July 12, 1999, in Bethesda, MD.  NIH staff
will explain the purpose of this RFA, provide instructions regarding the
application process, and answer questions.  Potential applicant institutions
are urged to send representatives to this briefing, both to gather information
and to exchange ideas with other potential applicants.  Upon request, anyone
who cannot attend the pre-application meeting will be provided with any
distributed materials and a summary of the discussion.  For further
information about this meeting, contact the NIGMS Program Staff listed under
INQUIRIES.

PHASE I APPLICATION PROCEDURES

Phase I awards are intended to support planning activities in order to
structure and organize the large scale collaborative project for submission as
a Phase II application.  In general, the Phase I application will be used to
gauge the merit of the basic idea and the conceptual framework for the
collaborative project; specific review criteria are discussed below. 
Prospective applicants must submit, by August 27, 1999, a Phase I application
that contains an overview of the proposed large scale collaborative project. 
Phase I applications will be evaluated by an appropriately constituted peer
review group.  Phase I applicants will be advised by October 15, 1999 whether
their applications will be funded.  Only Phase I awardees may submit Phase II
applications for scientific merit review.

Contents of Applications

Phase I and Phase II applications are to be submitted on the standard research
grant application form PHS 398 (rev. 4/98).  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] and on the Internet at
https://grants.nih.gov/grants/funding/phs398/phs398.html.

A Phase I response to this RFA should follow the PHS 398 instructions with the
following modifications:

Application face page. Complete all items.  This is page 1; number succeeding
pages consecutively. The RFA label found in the PHS-398 (rev. 4/98)
application form must be affixed to the bottom of the face page of the
application.  Failure to use this label could result in delayed processing of
the application such that it may not reach the review committee in time for
review. On line 2, the number and title of this RFA: GM-99-007, "Large-Scale
Collaborative Project Awards," must be entered and the YES box must be marked.

The Research Plan should be replaced with the following:

A statement (two page limit) by the principal investigator describing his/her
commitment, including percent effort, to the large-scale collaborative project
and identifying the members and percent effort of the steering committee.

A project summary (ten page limit) describing the scientific goals and
operation of the large scale collaborative project.  It is important to make
clear the significance of the biological problem chosen and what the value
added benefit will be from pursuing the problem with a collaborative project,
rather than individual grants. Approaches envisioned to the key elements of a
large-scale collaborative project should be described.  The roles that
bridging projects, pilot projects, and/or core resources will play in the
collaborative project should be described. The project summary will serve as
the research plan for the Phase I application.

Biographical sketches and letters of commitment from each of the participating
investigators that indicate their interest in joining the collaborative
project.

Other support pages should include only the grants of each participating
investigator that are in the area of the large-scale collaborative project.

Letters signed by the authorized business official of each of the
participating investigators' institutions committing support to the
collaborative project. Arrangements for the participation of investigators
from industry and foreign sites and resources they may bring to the
collaborative project should be documented.

A statement of institutional and other resources available to the consortium
(three pages).

A references section is permissible, but appendices will not be allowed as
part of a Phase I application since a detailed plan is not requested at this
stage.

A description of the proposed budget allocation (one page, in lieu of the PHS
398 budget section).  All Phase I awards will be for up to $25,000 for the
period November 1, 1999 to January 31, 2000.

Review Considerations

Upon receipt, Phase I applications will be reviewed for completeness by CSR
and responsiveness by the NIGMS.  Incomplete and/or non-responsive
applications will be returned to the applicant without further consideration. 
Phase I applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer review
group convened by the NIGMS in accordance with the review criteria stated
below.

As part of the initial merit review, a process may be used by the initial
review group in which Phase I applications receive a written critique and
undergo a process in which only those applications deemed to have the highest
scientific merit, generally the top half of the applications under review,
will be discussed and assigned a priority score.

Review Criteria:

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
consortium 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.

Significance.  Does this project address a complex biological problem of
overarching significance to biomedical science that would be difficult to
address by separate grants?  If the aims of the application are achieved, how
will the field of biomedical science be advanced?

Approach.  Is the conceptual framework appropriate to achieve the scientific
aims of the large scale collaborative project?

Innovation.  Are the project's structure and goals novel? Are the aims
original and innovative? Will the project attack a problem in a significantly
new way?  What will be the value added over individual grants?

Investigators.  Is the principal investigator's major research activity within
the research area of the collaborative project?  Is the principal investigator
well suited to the scientific and administrative leadership required to carry
out this work? Are the research grants of the participating investigators
within the area of the project?  Are the participating investigators well
chosen for their roles in the project? Do the commitments of the principal
investigator, steering committee members, and participating investigators
appear reasonable for the scope of the planned activities?

Environment.  Do the scientific environments in which the work will be done
contribute to the probability of success? Is the level of institutional
support adequate?

Additional review criteria for Phase I awards that will also be considered
include the commitment to the project by the principal investigator, the
members of the steering committee, and the participating investigators; the
commitment of the host university to supporting the consortium, reflected, for
example, in the willingness to work out potential intellectual property issues
prior to submission of the Phase II application and to remove any
institutional barriers to the establishment and healthy maintenance of the
large scale collaborative project.

Award Criteria

Award criteria that will be used to make funding decisions include:

o scientific merit (as determined by peer review)
o program priorities
o program balance
o availability of funds

PHASE II APPLICATION PROCEDURES

Phase I awardees may submit a Phase II application by January 21, 2000 for
peer review.  Phase II applications are to be submitted on the standard
research grant application form PHS 398 (rev. 4/98).  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] and on the
internet at https://grants.nih.gov/grants/funding/phs398/phs398.html.

The Phase II application should include detailed plans for the large-scale
collaborative project.  In addition to an assessment of the merit of the basic
idea and the conceptual framework, an assessment of the specific plans will be
conducted.

Contents of Applications

A Phase II response to this RFA should consist of an application that, in
addition to or in lieu of part of the items requested in the PHS 398,
includes:

Application face page. Complete all items.  This is page 1; number succeeding
pages consecutively. The RFA label found in the PHS-398 (rev. 4/98)
application form must be affixed to the bottom of the face page of the
application.  Failure to use this label could result in delayed processing of
the application such that it may not reach the review committee in time for
review. On line 2, the number and title of this RFA: GM-99-007, "Large Scale
Collaborative Project Awards," must be entered and the YES box must be marked.

Abstract of Research Plan.  On page 2, describe briefly the proposed large
scale-collaborative research project.  List all key personnel involved in the
collaborative project; use a continuation page if needed.

Table of Contents.  Prepare a Table of Contents that includes the items listed
below. The major areas to be listed in the Table of Contents appear here in
capital letters.

BUDGET ESTIMATES: Specific examples of allowable costs that may be requested
include:

Salaries for the principal investigator, members of the steering committee,
participating investigators, technical, and support personnel commensurate
with their level of effort in the large-scale collaborative project.

Bridging projects to the laboratories of participating
investigators.  Pilot projects to investigators without current independent
research support in the area.  These subprojects must not exceed $75,000 in
annual direct costs and must be limited to no more than three such projects
per application Travel of personnel, which may include technicians,
predoctoral students, postdoctoral trainees, and investigators, to different
laboratories to gain specialized expertise.

Travel to and conduct of regular meetings of the steering committee and
regular meetings of the participating investigators.

Core facilities (examples: instrumentation, genomics, proteomics, model
organism, high-throughput assay, or computational/bioinformatic cores).

Electronic media cores to allow participation of off-site laboratories and/or
the means necessary to establish collaboratory capabilities and for
information dissemination.  Travel to and conduct of regular meetings of an
advisory committee.

In addition to the overall budget, include a separate budget for each bridging
project and pilot project and each core resource.  Phase II applications for
large-scale collaborative project awards may not request more than $5 million
in annual direct costs (exclusive of subcontract indirect costs requested as a
direct cost by the applicant organization) for any year of the award. Salaries
for support personnel required for coordination and maintenance of the
project, such as secretaries, may also be included as necessary in an
administrative core.

Composite budget.  Use Form Page 4, "DETAILED BUDGET FOR INITIAL BUDGET
PERIOD," of Form PHS-398 to present the total budget for all requested support
for the first year.  For each category such as "Personnel," Equipment," etc.,
give the amount requested for each core unit and each component project, with
subtotals. For consortium arrangements involving other institutions or
organizations, include total (direct and facilities and administration) costs
associated with such third-party participation in the "Consortium/Contractual
Costs" category.  Costs for purchased services should be itemized under "Other
Expenses."

Use Form Page 5, "BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD," of Form PHS-398
to prepare a budget, by category, that provides totals for each year of
requested support.  Requests for any increases in succeeding years must be
justified in the individual component subprojects (bridging projects and pilot
projects) and core unit budgets.

Individual component core and research budgets.  For the first year budgets of
each of the cores and projects, use Form Page 4 of the PHS-398.  Use Form Page
5 of the PHS-398 to report the budgets of each of the projects and cores for
total project period (years 02-05).

Budget justifications and explanations.  Describe the specific functions of
all key personnel, including consultants, collaborators, and technical staff. 
Provide justifications for requested equipment.  For years 02-05 of the
application, justify any significant increases or decreases in any category
over the first year budget.

BIOGRAPHICAL SKETCHES AND LETTERS OF COMMITMENT: Biographical sketches and one
page letters of commitment must be included from all participating
investigators indicating their willingness to follow guidelines and procedures
established for the large-scale collaborative project.

RESOURCES AND ENVIRONMENT.  Complete the "Resources" page of PHS-398 for the
overall large-scale collaborative project, including both the host institution
and any participating institutions.  Briefly describe the features of the
institutional environment(s) that are relevant to the effective implementation
of the proposed program.  As appropriate, describe available resources, such
as clinical and laboratory facilities, participating and affiliated units,
patient populations, geographical distribution of space and personnel, and
consultative resources.

ANIMAL AND HUMAN SUBJECT ASSURANCES:  Because of the relatively short
turnaround time for review of Phase II applications, all IRB and IACUC
assurances must be completed (and not pending) at the time of submission of
the Phase II application.

RESEARCH PLAN

Include a detailed Table of Contents with pagination (numeric only) at the
beginning of the Research Plan.  Identify each component core with a capital
letter (A,B,C), as well as title, that reflects the order in which the core
units are presented in the application research plan.  For each core, provide
the name of the core director.

Page limitations: The lengths of the sections devoted to the project summary,
the cores, and the scientific projects must not exceed those specified below. 
Investigators should endeavor to be
concise.

PROGRAM SUMMARY (ten page limit): A project summary describing the goals and
operation of the project. Explain what complex biological problem will be
solved and how the approach of using a large-scale collaborative agreement is
critical to its solution.  Discuss the range of scientific expertise to be
brought to bear on the research problem.  Explain the interactions that will
occur between investigators at the host site and at the participating sites. 
Explain how each element of the large-scale collaborative project will
contribute to successful attainment of its goals. Explain the programmatic
value of the core resources, bridging projects, and pilot projects. Explain
how the information coming from the collaborative project and the laboratories
of the participating investigators will be integrated into comprehensive
whole.  Discuss how information generated by the collaborative project will be
disseminated to the scientific public.

ADMINISTRATIVE MANAGEMENT PLAN (five page limit): Describe the structure,
organization, and operation of the project. Describe the organizational
framework and provide an organizational chart and the flow of information
within the collaborative project. Discuss arrangements between the
collaborating institutions that are important to effective operation of the
large-scale collaborative project.  Detail the usage of the core resources by
the participating investigators.  Include any outreach efforts to provide
access to the core resources to investigators outside the collaborative
project.  Explain how decisions will be made to add/delete participating
investigators and to respond to changes in short term goals that research
findings will make necessary.  Discuss how the views of the scientific
community impacted by the collaborative project will be considered.

PROJECT MANAGEMENT PLAN (three page limit): Define, at a minimum, yearly
milestones. Present a project management plan, including milestones, to keep
the collaborative project moving forward and on track.  Explain how progress
in the bridging projects and pilot projects and efficiency of the core
resources will be tracked.  Include an evaluation plan to determine how the
collaborative project is progressing.  Discuss the plan for evolving
milestones. Explain how the advisory committee will be used in updating the
project management plan.

PLAN FOR DATA SHARING AND INTELLECTUAL PROPERTY (two page limit): The
principal investigator and steering committee should (1) propose a plan for
providing access to the data and information generated by the large-scale
collaborative project to the members of the project and the scientific public;
(2) address if or how intellectual property rights will be exercised; (3)
discuss guidelines for licensing of joint inventions; (4) discuss
procedures for settling of intellectual property disputes; (5) discuss the
existence of any pre-existing intellectual property rights, including options
to for-profit research sponsors; and (6) propose a plan for disseminating the
technologies, assays, and associated reagents developed under this RFA

CORE RESOURCE DESCRIPTIONS

CORE RESOURCE A.  ADMINISTRATIVE CORE (five page limit): This Core must be
directed by the principal investigator.  Include the objectives of the core, a
description of its staffing and services to be provided to other core
resources and to the participating investigators.  Communicating the
objectives of the collaborative project and fostering opportunities for
collaboration are encouraged.  Expenses associated with the operation of the
steering committee, meetings of all or subgroups of the participating
investigators, and meetings and operation of the advisory committee would fall
under the administrative core.

CORE RESOURCE B.  INFORMATION DISSEMINATION AND DATA COORDINATING CORE (three
page limit): Dissemination of information on techniques, scientific findings,
and methodologies is a vital component of each large-scale collaborative
project.  Computer technology, print media, and telecommunications are
relevant.  Describe the staffing (including a Core Director, as well as any
professional or technical personnel and their duties), facilities, and
resources that will be devoted to this goal.  Indicate plans to make results
of research or other unique features of the collaborative project available
for as wide an audience as possible.  Describe how data generated by the core
resources and the participating investigators will be processed into the
information to be disseminated.  Discuss plans for dissemination of published
and unpublished data.

CORE C (and others).  SCIENTIFIC RESOURCE CORE (S) (five page limit per core):
Provide specific titles for any proposed scientific resource cores (e.g.,
instrumentation; genomics; proteomics; model organism; high-throughput assay;
or computational, modeling, or bioinformatics), along with a designated Core
Director who possesses expertise in the area of each core.  Describe the
professional and technical staff to be involved in the core(s), and their
duties.  Include plans to utilize the core(s), including services that will be
provided, and to whom, and their bearing on productivity and quality of the
collaborative research effort.

PROJECTS

BRIDGING PROJECTS (five page limit for each bridging project for the research
plan: specific aims, background and significance, preliminary studies, and
research design and methods): Bridging projects will support work in the
laboratories of the participating investigators; these are essentially
supplements to their ongoing work.  For all proposed projects, the underlying
rationale and potential impact of the studies should be specifically
addressed. The need for the bridging project to tie (or enhance) the
independent work of the participating investigator to the goals of the
collaborative project must be described.  Projects must be described in
sufficient detail to permit evaluation through the competitive peer-review
process.  For each bridging project undertaken as part of the collaborative
project, include the following sections: Abstract (one paragraph), Specific
Aims, Background and Significance, Preliminary Studies, Research Design and
Methods, Children as Research Subjects, Human Subjects including gender and
minority considerations, Vertebrate Animals, and Literature Cited.

PILOT PROJECTS (ten page limit for each pilot project for the research plan:
specific aims, background and significance, preliminary studies, and research
design and methods; maximum of three pilot projects per large scale
collaborative project): Pilot projects will support the work of investigators
not already supported in the area of the collaborative project who have unique
skills or expertise to add to the collaborative project effort.  For all
proposed projects, the underlying rationale and potential impact of the
studies should be specifically addressed. How the pilot project will add new
elements essential to achieving the goals of the collaborative project must be
described.  Projects must be described in sufficient detail to permit
evaluation through the competitive peer-review process.  For each pilot
project undertaken as part of the collaborative project, include the following
sections: Abstract (one paragraph), Specific Aims, Background and
Significance, Preliminary Studies, Research Design and Methods, Children as
Research Subjects, Human Subjects including gender and minority
considerations, Vertebrate Animals, and Literature Cited.

INSTITUTIONAL COMMITMENTS: Letters signed by authorized business officials of
each of the participating investigators' institutions committing support to
the large-scale collaborative project must be included.  Applicants for Phase
II proposals that include consortium arrangements should refer to the NIH
Grants Policy Statement appendix on consortium arrangements at
https://grants.nih.gov/archive/grants/policy/nihgps/part_iii_5.htm#Consortium.

REVIEW CONSIDERATIONS

Upon receipt, Phase II applications will be reviewed for completeness by CSR
and responsiveness by the NIGMS.  Incomplete and/or non-responsive
applications will be returned to the applicant without further consideration. 
Applications that are complete and responsive to the RFA will be evaluated for
scientific and technical merit by an appropriate peer review group convened by
the NIGMS in accordance with the review criteria stated below.

As part of the initial merit review, a process may be used by the initial
review group in which applications receive a written critique and undergo a
process in which only those applications deemed to have the highest scientific
merit, generally the top half of the applications under review, will be
discussed, assigned a priority score, and receive a second level review by the
National Advisory General Medical Sciences Council.

Review Criteria for the Overall Large Scale Collaborative Project

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 large-
scale collaborative project 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.

1.  Significance.  Does this large-scale collaborative project address a
complex biological problem of overarching significance to biomedical science
that would be difficult to address by separate grants?  If the aims of the
application are achieved, how will the field of biomedical science be
advanced?  What will be the effect of these studies on the concepts or methods
that drive this field? Do the arrangements for data sharing maximize the
impact of the collaborative project?

2.  Approach.  Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the scientific aims
of the collaborative project?  Does the applicant acknowledge potential
problem areas and consider alternative tactics? Is the project management plan
adequate?  Is the administrative framework appropriate?  Do milestones
articulate key indicators set for appropriate times that will demonstrate
significant forward progress for the collaborative project?  Are the plans to
monitor and evaluate progress of the collaborative project adequate? Are the
plans to share the data and findings with the larger community adequate? How
will the group take the views of the scientific community impacted by the
large-scale collaborative project into consideration?

3.  Innovation.  Are the large-scale collaborative project's structure and
goals novel? Are the aims original and innovative? Will the collaborative
project challenge existing paradigms or develop new methodologies or
technologies?  Will the collaborative project attack a problem in a
significantly new way?  What will be the value added over individual grants?

4.  Investigators.  Is the principal investigator's major research activity
within the research area of the collaborative project?  Is the principal
investigator well suited to the scientific and administrative leadership
required to carry out this work?  Is the level of effort proposed for the
principal investigator and the members of the steering committee appropriate? 
Is the work proposed appropriate to the experience level of the collaborative
project's research and technical staff?  Are the research grants of the
participating investigators within the area of the collaborative project?  Are
the participating investigators well chosen for their roles in the
collaborative project?  Is the plan to add and delete participating
investigators to and from the collaborative project satisfactory?

Environment.  Do the scientific environments in which the work will be done
contribute to the probability of success?  Are support personnel and resources
in place to advance the work?  Will the proposed collaborative project take
advantage of unique features of the scientific environments of the component
projects?  Is the level of institutional support adequate?  Are the requested
core facilities critical to achieving the scientific goals of the
collaborative project; are they cost effective?  Is access to the core
facilities appropriate?

In addition, the following criteria will be considered for merit review: The
commitment to the project by the principal investigator and the members of the
steering committee will be a consideration.  For applications that are multi-
institutional or that involve industry, the adequacy of plans to resolve
intellectual property issues will be a consideration.  The commitment of the
host and participating universities to supporting the large scale
collaborative project will also be considered: this would be reflected in
efforts to work out ahead of time potential intellectual property issues and
to remove any institutional barriers to the establishment and healthy
maintenance of the collaborative project.

In accordance with NIH policy, all Phase II applications will be reviewed with
respect to the following:

o The adequacy of plans to include both genders, minorities and their
subgroups, and children, as appropriate for the scientific goals of the
research.  Plans for the recruitment and retention of subjects will also be
evaluated.

o The reasonableness 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.

Review Criteria for Core Resources.

Consideration of the technical merit of the core units will include:

(1) Facilities within the core compared to the state of the art.  The
contributions of the cores to fulfilling the goals of collaborative project.

(2) The extent to which core units promote greater collaboration and
cohesiveness among the participating investigators.

(3) Qualifications, experience, and commitment to the large-scale
collaborative project mission of the investigators responsible for the core
resources and their abilities to devote the required time and effort to the
program.

(4) Appropriateness of the budgetary requests.

Review Criteria for Bridging Projects and Pilot Projects

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 each project in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals. Each of the
criteria listed below will be addressed and considered in assigning the score
for a research project, weighting them as appropriate for each project.  Note
that the project 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.  In
their evaluations, reviewers will comment on:

(1) 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 achieving the goals of the
collaborative project?  Will the bridging project tie or enhance the
independent work of the participating investigator to the collaborative
project, or will the pilot project add an essential missing aspect to the
collaborative project?

(2) 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?

(3) Innovation.  Does the project employ novel concepts, approaches or method? 
Are the aims original and innovative?  Does the project challenge existing
paradigms or develop new methodologies or technologies?

(4) 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)?

(5) 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?

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

o The adequacy of plans to include both genders, minorities and their
subgroups, and children as appropriate for the scientific goals of the
research.  Plans for the recruitment and retention of subjects will also be
evaluated.

o The reasonableness 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.

The scientific review group will also examine the provisions for the
protection of human subjects and the safety of the research environment.

Award Criteria

Award criteria that will be used to make funding decisions include:

o scientific merit (as determined by peer review)
o program priorities
o program balance
o availability of funds

SUBMISSION PROCEDURES FOR PHASE I AND PHASE II APPLICATIONS

The RFA label available in the PHS 398 (rev. 4/98) application form must be
affixed to the bottom of the face page of Phase I and Phase II applications. 
Failure to use this label could result in delayed processing of the
application such that it may not reach the review committee in time for
review.  In addition, the RFA title and number must be typed on line 2 of the
face page of the application form and the YES box must be marked.

Submit a signed, typewritten original of the application (Phase I or Phase
II), including the Checklist, and three signed, exact photocopies, in one
package 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)

At the time of submission, two additional copies of the application (Phase I
or Phase II) and all five sets of any appendix material must be sent to:

Helen R. Sunshine, Ph.D., Chief
Office of Scientific Review
National Institute of General Medical Sciences
Building 45, Room Number 1As.13
Bethesda, MD  20892

Applications for Phase I must be received by August 27, 1999.  Applications
for Phase II applications must be received by January 21, 2000.  If an
application is received after the due date, it will be returned to the
applicant without review.  The Center for Scientific Review (CSR) will not
accept any application in response to this RFA that is essentially the same as
one currently pending initial review, unless the applicant withdraws the
pending application.  The CSR will not accept any application that is
essentially the same as one already reviewed.  This does not preclude the
submission of substantial revisions of applications already reviewed, but such
applications must include an introduction addressing the previous critique.

Schedule:

Public Briefing:                           July 12, 1999
Phase I Application Receipt Date:          August 27, 1999
Phase I Peer Review Date:                  October 1999
Phase I Award Date:                        November 1, 1999
Phase II Application Receipt Date:         January 21, 2000
Phase II Peer Review Date:                 March/April 2000
Advisory Council Date:                     May 2000
Earliest Anticipated Phase II Award Date:  September 2000

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to clarify any
issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Dr. Michael E. Rogers
Division of Pharmacology, Physiology and Biological Chemistry
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Bethesda, MD  20892-6200
Telephone:  (301) 594-3827
FAX:  (301) 480-2802
Email:  [email protected]

Dr. James C. Cassatt
Division of Cell Biology and Biophysics
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Bethesda, MD  20892-6200
Telephone:  (301) 594-0828
FAX:  (301) 480-2004
Email:  [email protected]

Dr. Judith H. Greenberg
Division of Genetics and Developmental Biology
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Bethesda, MD  20892-6200
Telephone:  (301) 594-0943
FAX:  (301) 480-2228
Email:  [email protected]

Direct inquiries regarding fiscal matters to:

Ms. Carol Tippery
Chief, Grants Management Office
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Bethesda, MD  20892-6200
Telephone:  (301) 594-5135
FAX:  (301) 480-1969
Email: [email protected]

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.821, 93.859, 93.862.  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 the NIH Grants Policy
Statement (10-1-98) and Federal Regulations 42 CFR 52 and 45 CFR Part 74. 
This program is not subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency review.

The Public Health Service (PHS) strongly encourages all award 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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