LARGE-SCALE COLLABORATIVE PROJECT AWARDS

RELEASE DATE:  March 21, 2002

RFA:  GM-02-007

National Institute of General Medical Sciences (NIGMS)
 (www.nigms.nih.gov)

APPLICATION RECEIPT DATE:  Phase I Applications, June 18, 2002
                           Phase II Applications, January 15, 2003

THIS APPLICATION CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanisms of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements for Cooperative Agreements
o Where to Send Inquiries
o Submission Procedures for Phase I Applications
o Peer Review Process for Phase I Applications
o Review Criteria for Phase I Applications
o Award Criteria for Phase I Applications
o Submission Procedures for Phase II Applications
o Peer Review Process for Phase II Applications
o Review Criteria for Phase II Applications
o Award Criteria for Phase II Applications
o Required Federal Citations

PURPOSE OF THIS RFA

The purpose of this RFA is to re-announce the National Institute of General 
Medical Sciences (NIGMS) program of "Large-Scale Collaborative Project 
Awards," (commonly called Large Glue Grants) last issued as GM-01-004 in 
February 2001.  This new announcement includes updates and modifications, and 
should be used in lieu of any previous announcements.

The goal of this program 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 is of central importance to biomedical science and to 
the mission of the NIGMS, and that would be beyond the means of any one 
research group.  It is expected that the participating investigators will 
already hold externally peer-reviewed and funded research grants in the area 
of the proposal.  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.  Phase I applicants 
will submit an overview of the proposed large-scale project for peer review.  
The purpose of the Phase I award is to provide resources for assembling a 
more fully developed proposal to applicants who have demonstrated the 
selection of an appropriate complex biological problem, an innovative 
approach to its solution, and appropriate commitments from participating 
investigators and institutions.  Successful Phase I applicants will receive a 
$25,000 (direct costs) planning grant. Those applicants, and only 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 initiatives to increase support opportunities 
for collaborative ventures.  A companion program, "Integrative and 
Collaborative Approaches to Research," 
(http://grants.nih.gov/grants/guide/pa-files/PA-00-099.html and 
http://grants.nih.gov/grants/guide/notice-files/NOT-GM-01-001.html), commonly 
called Small Glue Grants, is intended to support collaborative activities 
that are smaller in scale and scope than those requested in response to this 
RFA.  Small Glue Grants are for applications requesting up to $300,000 in 
direct costs per year.  Large Glue Grants are for applications requesting 
from $300,000 up to $5,000,000 in direct costs per year.  

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.

RESEARCH OBJECTIVES

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.  The first Large-Scale Collaborative Award announcement 
appeared in May 1999 and has been reissued in each subsequent year.  One 
award was made in FY 2000 and three awards were made in FY 2001 
(http://www.nigms.nih.gov/funding/gluegrants.html).

For most of the last 30 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 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 they also seek a means to encourage and 
facilitate the development of an interactive research network around a 
complex biological problem.

The purpose of this RFA 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 have become 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 requires the collaboration of many groups and 
laboratories.  Finally, large-scale, expensive technologies such as 
combinatorial chemistry, DNA microarrays, 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.nigms.nih.gov/about_nigms/overview.html). Participation by 
investigators doing mechanistic clinical science, as well as by investigators 
doing basic laboratory science, is welcomed.  It is also recognized that data 
collection and technology development may be logical and necessary parts for 
some or all large-scale collaborative projects.

Whether projects 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.  For examples of successful 
applications and results of previous competitions, visit the NIGMS glue grant 
website at http://www.nigms.nih.gov/funding/gluegrants.html.

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 would 
be substantially greater than the sum of the participants" individual 
achievements.  Each large-scale collaborative project could require 
considerable new resources, such as for a centralized core facility, but 
would also require a synthesis of information from participating 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 
application.

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 and Organization 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 appropriateness of 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.  The members should be chosen from 
participating investigators and project staff, and the membership should be 
representative of the scope 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 decision.  It is expected that the PI, 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 voting 
member of the steering committee and attend its meetings.  The steering 
committee will meet annually with the Advisory Committee, as described below.

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 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 PI 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, of at least three members, whose purpose is to 
meet annually with the PI 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 PI 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 and the names of prospective members should not be 
included in the application.  The NIGMS program director, responsible for the 
award, will attend the advisory committee meeting as a member of the steering 
committee but will not actually 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 ORGANIZATION AND 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 an information dissemination and data 
coordinating core.  Alternatively, the large-scale collaborative project may 
involve additional activities and may request the following types of 
resources, either as distinct entities or in integrated combinations.

Support to Individual Laboratories

Investigators are expected to bring their own support for their individual 
laboratories to the collaborative project.  The large-scale collaborative 
project award mechanism is not meant to support R01-type projects.  It is 
recognized, however, that in some cases, there may be a need for special 
efforts in the individual laboratories of the participating investigators to 
enhance the efforts of the consortium or to integrate the individual work of 
a participating investigator with the consortium.  Two mechanisms have been 
designated for this purpose:

Bridging projects may be used to support work in the laboratories of the 
individual participating investigators when that work is intended to provide 
either a bridging function to more fully integrate the individual work with 
the collaborative project or a service function to develop data or resources 
or technology to benefit the overall glue project. For example, support to 
allow a participating investigator to employ a standardized model system so 
that his/her results can be compared with results from other project members 
is appropriate. Another example is exchanging personnel among laboratories of 
different investigators to transfer technology between glue grant 
laboratories or for other purposes that would help in coordinating and 
integrating programmatic goals. Another might be to develop an assay to be 
used by consortium members.  These bridging projects to the laboratories of 
individual participating investigators should 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 and expertise 
of the participating investigator to the large-scale collaborative project. A 
bridging project should extend the participating investigator"s independent 
work in a new direction(s).  A bridging project to do more of what the 
investigator is already doing should be considered only if there are 
extraordinary circumstances that make it essential for the effective 
functioning of the large-scale project.  If the participating investigator"s 
work is already closely tied to the large-scale project, a bridging project 
should not be needed.  Stand-alone new research projects should not be 
submitted for bridging projects.  If a bridging project could be submitted as 
a regular R01 application, it should not be requested as a bridging project, 
even if it adds value to the large-scale project.  Judgment will be required 
on the part of applicants and reviewers alike to distinguish between projects 
that are appropriate for support by consortium resources and those that 
should be submitted and reviewed as regular research grants (R01s).

Pilot projects may be requested in this application for investigators without 
current independent support in the area of the collaborative project in order 
to add elements where gaps exist, or to add investigators with critical 
knowledge or expertise but who do not have 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 year 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. Applicants must explain why the principal 
investigator"s expertise is needed for the large-scale project and how the 
pilot project will contribute directly to accomplishing the aims of the 
large-scale project.  While funding for a pilot project may run for five 
years, at the discretion of the steering committee, it is expected that the 
PI of a pilot project will seek R01 funding during the period of the 
collaborative project, based on the results obtained from the pilot project.

Cores

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.  A bioinformatics core to include assemblage and 
organization of data for querying, developing tools for its querying, 
computation, and modeling may be requested as a separate core or be combined 
with the information dissemination core.  Other types of resources might be 
for instrumentation, genomics, proteomics, or high-throughput assay cores.  
Requests for core resources must be strongly justified in terms of value to 
achieve the goals of the project, value to increase 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 describes the 
organization of the project and outlines the policies and procedures whereby 
participating and non-participating investigators can have access to the 
collaborative project resources.  The application should address the flow of 
information within the project and plans as to how the information will be 
integrated into the solution of the biological problem being addressed. The 
application should address the mechanism that will be followed to add new 
participating investigators and delete members whose association with the 
project has not been productive.  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 should discuss the mechanism whereby concerns of the scientific 
community directly affected by the project will be considered and responded 
to.  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 and 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 the 
collaborative project"s progress and any recommendations to modify funding 
will be made annually to the National Advisory General Medical Sciences 
Council.

PLAN FOR HANDLING INTELLECTUAL PROPERTY AND SHARING OF RESEARCH RESOURCES:  
The nature of large-scale collaborative projects is to move entire fields 
forward.  NIGMS intends that, to the extent possible, all investigators 
within a field have equal access to research resources generated by these 
collaborative projects.  To address this interest in assuring that research 
resources are accessible, NIH requires applicants who respond to this RFA to 
(1) submit a plan for sharing the research resources generated through the 
award, and (2) address how they will exercise intellectual property rights, 
should any be generated through this award, while making such research 
resources available to the broader scientific community. It is expected that 
resources to be shared will include, among others, data and information, 
materials such as cell lines and mutant animals, and novel reagents and 
techniques.

The sharing of research resources plan and intellectual property plan must 
make unique research resources readily available for research purposes to 
qualified individuals within the scientific community in accordance with the 
NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps/) and 
the Principles and Guidelines for Recipients of NIH Research Grants and 
Contracts on Obtaining and Disseminating Biomedical Research Resources: Final 
Notice, December 1999 (http://www.ott.nih.gov/policy/rt_guide_final.html and 
http://ott.od.nih.gov/NewPages/64FR72090.pdf).  These documents also define 
terms, parties, responsibilities, prescribe the order of disposition of 
rights, prescribe a chronology of reporting requirements, and delineate the 
basis for and extent of government actions to retain rights.  Patent rights 
clauses may be found at 37 CFR Part 401.14 and are accessible from the 
Interagency Edison web page, http://www.iedison.gov.

As noted below (see Peer Review Process and Review Criteria), the scientific 
review group will comment, as appropriate, on the adequacy and feasibility of 
the sharing of research resources plan and the intellectual property plan. 
The review group will describe the adequacy of the plans in an administrative 
note and the evaluation of the plans per se will not affect the priority 
score.  However, because dissemination is a critical aspect and fundamental 
purpose of this RFA, evidence of the commitment of the large-scale project 
leadership to the sharing or research resources and to effective management 
of intellectual property issues will be part of the scientific merit review.  
The adequacy of the proposed sharing plans will be an important factor in the 
institute"s decision to make an award.  Furthermore, the proposed sharing 
plans, after negotiation with the applicant when necessary, will be made a 
condition of the award.  Evaluation of annual progress reports and of 
subsequent renewal applications will include an assessment of the 
effectiveness of the sharing of research resources.

DISCLOSURES: It is 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.

MECHANISMS 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 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 PI 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 September, 2002.  
The length of the Phase I awards may be for up to one year and do not count 
against the time limit for Phase II awards.

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 2003.  Phase II awards will be 
considered for one five-year renewal period following the initial award.

The NIH U54 is a cooperative agreement award mechanism in which the Principal 
Investigator retains the primary responsibility and dominant role for 
planning, directing, and executing the proposed project, with the NIH staff 
being substantially involved as a partner with the Principal Investigator, as 
described under the section "Special Requirements for Cooperative Agreements, 
Terms and Conditions of Award."

This RFA is a one-time solicitation.  In addition to new applications, both 
revised Phase I applications and revised Phase II applications from the 
previous two announcements (RFA GM-01-004 and Notice GM-00-001) will be 
accepted.  However, NIGMS will accept for consideration only one revision of 
a previously submitted, unfunded Phase I or Phase II application.  Twice-
amended applications will not be accepted.  If the solicitation is re-
announced within a two-year period of this announcement, revised Phase I and 
Phase II applications from this announcement will again be accepted.  

FUNDS AVAILABLE

NIGMS intends to commit approximately $10-15 million in total costs in FY2003 
to fund Phase II awards.  NIGMS anticipates making up to ten Phase I awards 
from FY2002 funds, Phase I awards will be for $25,000 in direct costs.  
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 from NIGMS funds will be $5 million in 
annual direct costs in any given year.  Applications of different scales and 
scope are encouraged. Applications requesting direct costs between $300,000 
and $5,000,000 per year will be considered responsive to this announcement.  
Although the financial plans of NIGMS provide support for this program, 
awards pursuant to this RFA are contingent upon the availability of funds and 
the receipt of a sufficient number of meritorious applications.  NIGMS 
anticipates re-announcing the solicitation for the next fiscal year, 
depending on the availability of funds.  

ELIGIBLE INSTITUTIONS

You may submit (an) application(s) if your institution has any of the 
following characteristics:

o Non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government

For-profit and foreign institutions are not eligible to submit an application 
as the lead institution.  However, a collaborative project may include 
participating investigators from foreign and/or for-profit organizations.  
Multi-institutional applications are encouraged.  

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Applications must fall directly into the areas of research supported by the 
National Institute of General Medical Sciences.  Applicants may visit the 
Institute website at http://www.nigms.nih.gov for information on NIGMS areas 
of interest.  Applicants may also wish to visit the NIGMS website created for 
this RFA and the PA (referred to in the Purpose of this RFA section) at 
http://www.nigms.nih.gov/funding/gluegrants.html.  Applicants are strongly 
advised to contact the NIGMS staff listed below to discuss NIGMS areas of 
interest and the eligibility of a proposed project.

The major research activity of the PI must be in the research area of the 
collaborative project application, and the PI is expected to make an 
appropriate level of commitment of effort to directing and managing the 
operation of the project, a substantial level of effort will be necessary to 
manage projects of largest magnitude.  While NIGMS expects that the 
applications will be multi-institutional with more than one participating 
investigator, minimum and maximum numbers of participating investigators or 
institutions have not been set.  Individuals from underrepresented racial and 
ethnic groups, as well as individuals with disabilities, are encouraged to 
apply for NIH programs.

SPECIAL REQUIREMENTS FOR COOPERATIVE AGREEMENTS

TERMS AND CONDITIONS OF AWARD: The following section is repetitive of 
previous sections but represents Terms and Conditions that will be 
incorporated into the award statement and will be provided to the PI, 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.

Principal Investigator Responsibilities:

The PI 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 PI 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 PI 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 projects are also included.  
Participating investigators will work with the PI, 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 in 
the 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 PI, 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 PI 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 PI 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 for-profit 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.  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 provide advice to the steering committee of the 
large-scale collaborative project about meeting its goals and to comment on 
plans for future directions.  The advisory committee will raise issues for 
consideration by the PI 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.

Handling Intellectual Property and Sharing of Research Resources:

Awardees will retain custody of and have primary rights to the research 
resources developed under these awards, subject to Government rights of 
access consistent with current DHHS, PHS, and NIH policies.  Awardees should 
comply with their institutional intellectual property policies and practices 
as described in the application and approved in this award. Consistent with 
the objectives of this award, awardees will be expected to share (make 
available) these research resources openly with the scientific community.
 
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 steering committee without NIH 
staff voting, 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.

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into three 
areas: scientific/research, peer review, and financial or grants management 
issues:

o Direct your questions about scientific/research 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:  rogersm@nigms.nih.gov

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:  cassattj@nigms.nih.gov

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:  greenbej@nigms.nih.gov

Direct your questions about peer review issues to:

Dr. Helen R. Sunshine
Office of Scientific Review
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Bethesda, MD  20892-6200
Telephone: (301) 594-2881
FAX: (301) 480-8506
Email:  sunshinh@nigms.nih.gov

Direct inquiries regarding fiscal matters to:

Mr. Joseph Ellis
Chief, Grants Management Office
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Bethesda, MD  20892-6200
Telephone:  (301) 594-5510
FAX:  (301) 480-1969
Email: ellisj@nigms.nih.gov

SUBMISSION PROCEDURES FOR A PHASE I APPLICATION

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 June 18, 2002, 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 September 2002 whether 
their applications will be funded.  Only Phase I awardees may submit Phase II 
applications for scientific merit review.

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.

SUPPLEMENTAL INSTRUCTIONS: A Phase I response to this RFA should follow the 
PHS 398 instructions, with the following modifications, and the parts should 
be assembled in the order prescribed by the PHS 398:

Application face page. Complete all items.  This is page one, number 
succeeding pages consecutively.

For listing of personnel on page two, it is important that 1) all 
participants, including consultants and private sector alliances, 2) all the 
institutional affiliations for each participant, and 3) their roles on the 
project, be included.  

Include 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 a six-month period of support.

Biographical sketches and letters of commitment from each of the 
participating investigators who indicate their interest in joining the 
collaborative project should be included.  Biographical sketches should 
include a listing of other support that includes only the grants of each 
participating investigator that are in the area of the large-scale 
collaborative project.

The statement of institutional and other resources available to the 
consortium should be limited to three pages.

The Research Plan should be replaced with the following:

A statement (two-page limit) by the PI describing his/her commitment to the 
large-scale collaborative project and identifying the members and the 
commitment of the steering committee. This section should also include a 
statement of commitment to developing a plan for handling intellectual 
property and the sharing of research resources.

A project summary (ten page limit) describing the scientific goals and 
operation of the large-scale collaborative project.  Explain what complex 
biological problem will be solved. Describe in adequate detail and explain 
the scientific approach to this problem. Explain why a large-scale 
collaborative project is critical to its solution.  Describe the range of 
scientific expertise to be brought to bear on the problem.  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.

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.

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

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  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. The RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
 
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the Checklist, and three signed, 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 Phase I application 
and all five sets of any appendix material must be sent to: 

Helen R. Sunshine, Ph.D.
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 June 18, 2002. If an application 
is received after the due date, it will be returned to the applicant without 
review.  The 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.

RECEIPT AND REVIEW SCHEDULE:

Phase I Application Receipt Date:         June 18, 2002
Phase I Peer Review Date:                 August 2002
Phase I Award Date:                       September 2002
Phase II Application Receipt Date:        January 15, 2003
Phase II Peer Review Date:                March/April 2003
Advisory Council Date:                    May 2003
Earliest Anticipated Phase II Award Date: September 2003

PEER REVIEW PROCESS FOR PHASE I APPLICATIONS

Upon receipt, Phase I applications will be reviewed for completeness by the 
Center for Scientific Review (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 scientific review group convened by the 
NIGMS in accordance with the review criteria stated below.  As part of the 
initial merit review, all applications will:

o Receive a written critique,

and may:

o 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 FOR PHASE I 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 your application in order to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of these 
goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The scientific review group will address and consider each of these criteria 
in assigning your application"s overall score, weighting them as appropriate 
for each application. 

(1)  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, 
will the field of biomedical science be advanced?

(2)  APPROACH:  Is the conceptual framework appropriate to achieve the 
scientific aims of the large-scale collaborative project?

(3)  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?

(4)  INVESTIGATORS:  Is the PI"s major research activity within the research 
area of the collaborative project?  Is the PI 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 PI, steering committee members, and 
participating investigators appear reasonable for the scope of the planned 
activities?

(5)  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:  In addition to the above criteria, Phase I 
applications will be reviewed with respect to the following:

o commitment to the project by the PI, the members of the steering committee, 
and the participating investigators.
o commitment to the sharing of research resources with the broader scientific 
community.
o 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 FOR PHASE I APPLICATIONS

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

o scientific merit (as determined by peer review)
o adequacy of plans for handling of intellectual property and sharing of 
research resources
o program priorities
o program balance
o availability of funds

SUBMISSION PROCEDURES FOR A PHASE II APPLICATION

Phase I awardees may submit a Phase II application by January 15, 2003 for 
peer review.  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.

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.

SUPPLEMENTAL INSTRUCTIONS:  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. 

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 detailed Table of Contents that includes all 
elements of the application.  Use numeric pagination only.  The major areas 
to be listed in the Table of Contents appear here in capital letters.  Units 
should be presented in the order in which they appear in the application.  
Under Research Plan, identify each component core with a capital letter (A, 
B, C), as well as title, and provide the name of the core director.  

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

Salaries for the PI, members of the steering committee, participating 
investigators, and 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 fellows, 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, or high-throughput assay cores).

Electronic media cores to allow participation of off-site laboratories and/or 
the means necessary to establish collaboratory capabilities and to 
disseminate information.  

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, but 
including all equipment) 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 01-05).

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 must 
be included from all participating investigators along with one page letters 
of commitment indicating their willingness to follow guidelines and 
procedures established for the large-scale collaborative project. For all 
participating investigators, including the PI, and heads of core resources, 
provide a listing of all other support, support for other investigators such 
as postdoctoral students should not be listed.  Include the relevant grant 
support that allows participating investigators to be part of the large-scale 
collaborative project.  Provide the specific aims of the project and describe 
in sufficient detail for evaluation of the relationship of the funded grant 
to the goals of the proposed large-scale project.

RESEARCH 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, IACUC assurances must be 
completed (and not pending) at the time of submission of the Phase II 
application.  However, IRB approval is no longer required prior to review, 
but only prior to funding (http://grants.nih.gov/grants/guide/notice-
files/NOT-OD-00-031.html).

PARTICIPANT AFFILIATIONS:  Applications should include a separate cover sheet 
that lists 1) all participants, including consultants and private sector 
alliances, 3) all the institutional affiliations for each participant, 3) 
their roles on the project, and 4) the percent effort for each role.  This 
added requirement will facilitate the review of applications.

Research Plan

Instructions for organization of the large-scale project research plan:

The NIGMS wishes to provide applicants with the flexibility to organize 
large-scale collaborative projects in the manner which best facilitates 
progress on the project being pursued.  Therefore, applicants may organize 
and present their large-scale collaborative project applications using the 
straightforward format that follows, or alternate formats for some parts of 
the application.  Required components of all applications are the program 
summary, including administrative and program management plans, a plan for 
data sharing and intellectual property, and Cores A (administrative) and B 
(information dissemination and data coordinating).  If desired, Core B may be 
may be combined with an optional bioinformatics core (the page limit for the 
combined unit will be 20 pages).   

The remainder of the Research Plan may be organized as deemed appropriate, 
keeping in mind that the major purpose of a large-scale collaborative project 
award is to provide resources to enable collaboration rather than primary 
research support.  For example, the scientific cores and bridging projects 
may be presented in a combined or more integrated fashion.  When this, or a 
different alternate format is used, applicants should explain, in the program 
summary, why a different organizational structure is proposed.  Any combined 
unit may not exceed the sum of the page limits that would have been allowed 
for the individual pieces of the unit. For example, if two bridging projects 
were submitted as a combined unit, the page limit for the combined unit would 
be twice that for one bridging project.  In all cases, the Research Plan, 
including the required components, may not exceed 160 pages.  The Research 
Plan includes the program summary, the administrative management plan, the 
project management plan, the plan for handling intellectual property and 
sharing of research resources, the administrative and information 
dissemination cores, as well as any optional cores, bridging projects, and 
pilot projects.  

PROGRAM SUMMARY: Describe the goals and operation of the large-scale 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 used to address 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: Describe the structure, organization, and 
operation of the project. Describe the organizational framework and provide 
an organizational chart.  Also describe how information will flow 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 necessitated by research 
findings.  Discuss how the views of the scientific community that are 
impacted by the collaborative project will be considered. 

PROJECT MANAGEMENT PLAN: 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.

PAGE LIMITS: The program summary, administrative management plan and the 
project management plan sections when combined have an aggregate page limit 
of 30 pages.  Page limits for other sections are given within each section 
and a summary follows at the end.  Investigators should endeavor to be clear 
and concise.

PLAN FOR HANDLING INTELLECTUAL PROPERTY AND SHARING OF RESEARCH RESOURCES 
(three-page limit): The PI and steering committee should (1) propose a plan 
for providing access to the research resources generated by the large-scale 
collaborative project to the members of the project and the scientific 
public, research resources include, among others, data and information, 
materials such as cell lines and mutant animals, and novel reagents and 
techniques,  (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 research resources developed under this RFA.

Core Resource Descriptions

CORE RESOURCE A.  ADMINISTRATIVE CORE (five-page limit): This core must be 
directed by the PI.  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 (five-
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 
to 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 RESOURCE C. BIOINFORMATICS CORE (OPTIONAL AND MAY BE COMBINED WITH CORE 
B.) (15 page limit):  A bioinformatics core to include assembly and 
organization of data for querying, developing tools for its querying, 
computation, and modeling may be requested as a separate core or be combined 
with the information dissemination core (combining the page limits).  The 
core description must include answers to the following bioinformatics 
queries, whether a separate core or combined with the information 
dissemination and data coordinating core.  The answers to the questions 
should both facilitate the planning for bioinformatics needs as well as 
provide important information for the peer review of the application. 

o What are the data release policies and what are the associated intellectual 
property issues?
o How will the data be available to the scientific community?   Will there be 
browser access, formats for downloading complete data sets, on-line 
computational aids, etc.?
o What is the nature and structure of the data?  Present the plans to date 
for ontologies, schema, or other data models. 
o What is the underlying structure of the database, e.g., relational, object-
oriented, etc.?
o What is the mechanism for communication (both computational and human) 
between the distributed sites and the database managers?  Will there be data 
liaisons?
o What are the key interacting databases?  How will the data be linked?
o How will progress be available to the public, e.g., will lists of the 
systems being analyzed be available?
o What experience in bioinformatics is available in the group, and what 
resources can the consortium draw on?

CORE D.  SCIENTIFIC RESOURCE CORE (S) (ten-page limit per core): Provide 
specific titles for any proposed scientific resource cores (e.g., 
instrumentation, genomics, proteomics, model organism, or high-throughput 
assay), 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, i.e., specific aims, background and significance, preliminary studies, 
and research design and methods): Bridging projects will support work in the 
laboratories of the participating investigators.  Describe the new research 
proposed in the bridging project and explain how this work more fully 
integrates the participating investigator"s independently-supported work into 
the large-scale collaborative project or provides a necessary service 
function or technology to the collaborative project.  For all proposed 
projects, the underlying rationale and potential impact of the studies should 
be specifically addressed. 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 a 
combined summary of the specific aims, background and significance, 
preliminary results, and research design and methods.  Also include, as 
applicable, the following sections, which do not count against the page 
limitations: Abstract (one paragraph), Human Subjects Research (also see 
special requirements in the Federal citations below), Vertebrate Animals, and 
Literature Cited.

PILOT PROJECTS (ten page limit for each pilot project for the research plan, 
i.e., 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, and Research Design and Methods.  As 
applicable, include sections on Human Subjects Research (also see special 
requirements in the Federal citations below), Vertebrate Animals, and 
Literature Cited.

SUMMARY OF PAGE LIMITS:

o Combined length of the project summary, administrative management plan, and 
the project management plan – 30 pages
o Plan for handling intellectual property and sharing research resources – 3 
pages
o Administrative core – 5 pages
o Information dissemination and data coordinating core – 5 pages
o Bioinformatics core (optional) – 15 pages
o Scientific cores (optional) – 10 pages each
o Bridging projects (optional) – 5 pages each
o Pilot projects (optional) – 10 pages each
o Combined units (optional) – pages equal to combined total for individual 
elements
o Overall limit for the Research Plan – 160 pages  

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 applications that include consortium arrangements should refer to 
the NIH Grants Policy Statement appendix on consortium arrangements at 
http://grants.nih.gov/grants/policy/nihgps/part_iii_5.htm#Consortium.

APPENDICES: Appendices are allowed for the Phase II applications, but they 
should follow the rules for appendices in the PHS 398 instructions.

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  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. The RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
 
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the Checklist, and three signed, 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 Phase II application 
and all five sets of any appendix material must be sent to: 

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

Applications for Phase II applications must be received by January 15, 2003.  
If an application is received after the due date, it will be returned to the 
applicant without review.  The 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.

RECEIPT AND REVIEW SCHEDULE:

Phase I Application Receipt Date:         June 18, 2002
Phase I Peer Review Date:                 August 2002
Phase I Award Date:                       September 2002
Phase II Application Receipt Date:        January 15, 2003
Phase II Peer Review Date:                March/April 2003
Advisory Council Date:                    May 2003
Earliest Anticipated Phase II Award Date: September 2003

PEER REVIEW PROCESS FOR PHASE II APPLICATIONS

Upon receipt, Phase II applications will be reviewed for completeness by the 
Center for Scientific Review (CSR) and responsiveness by the NIGMS.  
Incomplete and/or non-responsive applications will be returned to the 
applicant without further consideration.  Phase II applications that are 
complete and responsive to the RFA will be evaluated for scientific and 
technical merit by an appropriate scientific review group convened by the 
NIGMS in accordance with the review criteria stated below.  As part of the 
initial merit review, all applications will:

o Receive a written critique,
o Receive a second level review by the National Advisory General Medical 
Sciences Council,

and may:

o 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 FOR PHASE II APPLICATIONS

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 your application in order to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of these 
goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The scientific review group will address and consider each of these criteria 
in assigning your application"s overall score, weighting them as appropriate 
for each application.  Your 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, you may propose to carry out 
important work that by its nature is not innovative but is essential to move 
a field forward.

(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, will the field of biomedical science be advanced?  
Will these studies affect, in a meaningful and important way, the concepts or 
methods that drive this field?  Is there a commitment to maximize the impact 
of the collaborative project through the sharing of research resources 
generated by the large-scale 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? Will the 
research resources generated by the large-scale project be shared with the 
larger community? 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?  Will there be value added over individual grants?

(4)  INVESTIGATORS:  Is the PI"s major research activity within the research 
area of the collaborative project?  Is the PI well suited to the scientific 
and administrative leadership required to carry out this work?  Is the level 
of effort proposed for the PI 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?

(5)  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 and are they cost effective?  Is access to the core 
facilities appropriate?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

o PROTECTIONS:  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 adequacy of the data and safety 
monitoring plans (required for clinical trials).

o INCLUSION:  The adequacy of plans to include subjects from both genders, 
all racial and ethnic groups (and subgroups), and children as appropriate for 
the scientific goals of the research.  Plans for the recruitment and 
retention of subjects will also be evaluated. (See Inclusion Criteria 
included in the section on Federal Citations, below.)  

o BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

In addition, the following criteria will be considered: 

o Commitment to the project by the PI and the members of the steering 
committee.
o Commitment of the host and participating universities to supporting the 
large-scale collaborative project, e.g., 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.
o Commitment of the leadership to the sharing of research resources generated 
by the large-scale project with the broader scientific community.

In an administrative note, the reviewers will comment on the adequacy of the 
proposed plans to deal with intellectual property issues for the 
collaborative project and the adequacy of the plans to share research 
resources (including data and information, materials such as cell lines and 
mutant animals, and novel reagents and techniques).  

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 your application in order to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of these 
goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The scientific review group will address and consider each of these criteria 
in assigning your application"s overall score, weighting them as appropriate 
for each application.  Your 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, you may propose to carry out 
important work that by its nature is not innovative but is essential to move 
a field forward.

(1) SIGNIFICANCE:  Does this study address an important problem? If the aims 
of the application are achieved, how will scientific knowledge be advanced?  
Will these studies be effective in 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?  Is the proposed work appropriate for support by the 
large-scale collaborative project or would it be more appropriate for support 
by a regular research grant?

(3) 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?

(4) INVESTIGATORS:  Is the investigator appropriately trained and well suited 
to carry out this work?  Is the work proposed appropriate to the experience 
level of the PI 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?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

o PROTECTIONS:  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.

o INCLUSION:  The adequacy of plans to include subjects from both genders, 
all racial and ethnic groups (and subgroups), and children as appropriate for 
the scientific goals of the research.  Plans for the recruitment and 
retention of subjects will also be evaluated. (See Inclusion Criteria 
included in the section on Federal Citations, below.)

o BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

AWARD CRITERIA FOR PHASE II APPLICATIONS

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

o scientific merit (as determined by peer review)
o adequacy of plans for handling of intellectual property and sharing of 
research resources
o program priorities
o program balance
o availability of funds

REQUIRED FEDERAL CITATIONS

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH:  It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating 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 clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-
files/NOT-OD-02-001.html), a complete copy of the updated Guidelines are 
available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.ht
m.  The amended policy incorporates: the use of an NIH definition of 
clinical research, updated racial and ethnic categories in compliance with 
the new OMB standards, clarification of language governing NIH-defined Phase 
III clinical trials consistent with the new PHS Form 398, and updated roles 
and responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable, 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy 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 is available at 
http://grants.nih.gov/grants/funding/children/children.htm. 

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy 
requires education on the protection of human subject participants for all 
investigators submitting NIH proposals for research involving human subjects.  
You will find this policy announcement in the NIH Guide for Grants and 
Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on 
hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).   
It is the responsibility of the applicant to provide the official NIH 
identifier(s)for the hESC line(s)to be used in the proposed research.  
Applications that do not provide this information will be returned without 
review. 

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) cited 
publicly and officially by a Federal agency in support of an action that has 
the force and effect of law (i.e., a regulation) may be accessed through FOIA.  
It is important for applicants to understand the basic scope of this 
amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application. In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals 
for NIH funding must be self-contained within specified page limitations. 
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) 
should not be used to provide information necessary to the review because 
reviewers are under no obligation to view the Internet sites.   Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving 
the health promotion and disease prevention objectives of "Healthy People 
2010," a PHS-led national activity for setting priority areas. This RFA is 
related to one or more of the priority areas. Potential applicants may obtain 
a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance No. 93.821, 93.859, and 93.862 and is not subject 
to the intergovernmental review requirements of Executive Order 12372 or 
Health Systems Agency review.  Awards are made under authorization of 
Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 
and 284) and administered under NIH grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm  and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92. 

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the use of all tobacco products.  In addition, 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care, or early 
childhood development services are provided to children.  This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

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