LARGE-SCALE COLLABORATIVE PROJECT AWARD RENEWALS
 
RELEASE DATE:  December 17, 2003
 
RFA Number:  RFA-GM-04-001

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
 (http://www.nih.gov)
 
COMPONENT OF PARTICIPATING ORGANIZATION:  
National Institute of General Medical Sciences (NIGMS) 
 (http://www.nigms.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.859
 
APPLICATION RECEIPT DATES:  October 19, 2004 for FY 2005 Awards
                            October 19, 2005 for FY 2006 Awards
                            October 19, 2007 for FY 2008 Awards
 
THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to become Principal Investigators
o Special Requirements
o Where to send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria for the Overall Project
o Review Criteria for Core Resources
o Review Criteria for Bridging and Pilot Projects
o Additional Review Criteria for All Components
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA 

The purpose of this solicitation is to invite the submission of renewal 
applications and to describe application, review, and award procedures 
for the renewal of large-scale collaborative project awards (commonly 
called “glue grants”, 
http://www.nigms.nih.gov/funding/gluegrants.html).  This announcement 
applies to awards whose support from the National Institute of General 
Medical Sciences (NIGMS) for the Phase II application began in FY 2000, 
FY 2001, and FY 2003 (no awards were made in FY 2002).  [New 
applications for large-scale collaborative project awards are not 
currently being accepted by NIGMS and are not part of this request for 
applications (RFA).  NIGMS may consider re-opening this program for new 
awards at a future date.]

NIGMS issued the first RFA for large-scale collaborative project awards 
in 1999, and the program was reannounced in each of the next three 
years.  One award was made in FY 2000, three awards were made in FY 
2001, and one award was made in FY 2003.  Each of these awards was made 
for five years.  Currently active large-scale collaborative project 
awards are eligible to compete for one renewal period of up to five 
additional years of support.  

Critical elements of these renewal applications will include evidence 
that a highly integrated and functioning team has been established; 
that good progress is being made; that the progress makes feasible 
accomplishment of the final goals in the next time period; that results 
have been achieved that could not have been accomplished by individual 
efforts alone; that plans for the next project period are compelling; 
and that plans have been made to accommodate the termination of NIGMS 
support at the end of that period.  Overall, the applications should 
describe the proposed and unanticipated challenges that were met, how 
the project has evolved, where it stands currently, and how the final 
phase will be achieved.
 
RESEARCH OBJECTIVES

The NIGMS held several meetings with members of the scientific 
community in FY 1998 and 1999 to assess the needs and opportunities for 
future research in areas supported by NIGMS.  A common theme that 
emerged from these meetings was the strongly felt need of the academic 
community to have an award mechanism that facilitated the interaction 
of independently funded scientists from the same and different 
disciplines to work together as teams on common problems in biomedical 
science.  

It appeared that a new direction in the conduct of science was emerging 
and the large-scale collaborative project awards were originated as a 
new mechanism to meet this need.  The suggestion was made to call these 
new awards “glue grants” because they were meant to glue together 
independently funded scientists.  The general parameters for these 
awards were as follows and remain applicable to the applications: the 
solution of a major question in biomedical science where a synthesis of 
information from participating laboratories is necessary; each of the 
participating investigators has to hold competitive independent support 
in the area of the glue grant; the funds are meant to support only 
collaborative and integrative activities; and the biological question 
has to fall within the mission of NIGMS (see 
http://www.nigms.nih.gov/about/overview.html for scope of NIGMS 
interests). 

The goals of this program remain the same: to enable the solution of 
major problems in biomedical research and to facilitate the next 
evolutionary stage of integrative biomedical science.  It is expected 
that the research problem selected for the originally funded 
application will remain the focus of the renewal application.  

The renewal application should provide a detailed explanation of the 
proposed project.  It should explain how the project has evolved over 
time and where it stands on the path to achieving its final goals.  It 
should also include specific intermediate goals (milestones) for the 
next period of support and a timeline for their accomplishment.  
Progress made on the overall goals of the collaborative projects and on 
the individual elements will be a major factor in the assessment of the 
renewal applications, and future plans should build on the progress to 
date.  Not only must adequate progress be demonstrated, but advances 
that could not have been achieved with purely individual efforts must 
be clearly articulated.  The effective functioning of the collaborative 
project team must be made clear.  One assessment of the team’s 
functioning will be the challenges met, the decisions made, and changes 
in direction implemented.

A special feature of the renewal applications will be the plans for 
these consortia beyond the renewal funding period.  Large-scale 
collaborative project awards have a maximum limit of ten years of 
support (five years for the original award and five years for the 
renewal period).  The renewal application must describe plans for 
bringing this activity to an orderly conclusion or for continuation 
through other sources of support.  In addition, these awards may have 
generated research resources that need to be continued beyond the life 
of the large-scale project.  Plans for long-term maintenance and 
management of such resources must be included.  Thus, the plans beyond 
year ten of these collaborative projects will receive close scrutiny by 
the scientific review group, by the advisory council, and by institute 
staff in reaching their recommendations.

MECHANISM OF SUPPORT
 
This RFA will use the NIH Specialized Center (U54, Cooperative 
Agreements) award mechanism.  As an applicant you will be responsible 
for planning, directing, and executing the proposed project.  This RFA 
is a one-time solicitation.  The anticipated award dates are September 
2005, September 2006, and September 2008, as appropriate. 

Amended renewal applications will not be accepted.  

This RFA uses just-in-time concepts.  Follow the instructions for non-
modular budget research grant applications.  This program does not 
require cost sharing as defined in the current NIH Grants Policy 
Statement at 
http://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm.  

The NIH U54 is a cooperative agreement award mechanism.  In the 
cooperative agreement mechanism, the Principal Investigator retains the 
primary responsibility and dominant role for planning, directing, and 
executing the proposed project, with NIH staff being substantially 
involved as a partner with the Principal Investigator, as described 
under the section "Cooperative Agreement Terms and Conditions of 
Award."  NIGMS does not plan to continue large-scale cooperative 
project awards beyond one renewal period.  However, the institute will 
consider applications for our usual award mechanisms, such as R01 
applications, to continue research resources generated by these 
consortia beyond the lifetime of the large-scale award.  

FUNDS AVAILABLE
 
NIGMS intends to commit the funds necessary for the competing 
continuation of all ongoing large-scale collaborative project awards.  
An applicant may request a project period of up to five years and a 
budget for direct costs of up to $5M per year.  Because the nature and 
scope of the proposed research will vary from application to 
application, the size and duration of each award may also vary.  
Although the financial plans of the NIGMS provide support for this 
program, awards pursuant to this RFA are contingent upon the 
availability of funds and the receipt of highly meritorious 
applications.  
 
ELIGIBLE INSTITUTIONS
 
You may submit a competing-continuation application in response to this 
RFA if your institution was awarded a large-scale collaborative project 
award from NIGMS in FY 2000, FY 2001, or FY 2003, or if, with the 
approval of NIGMS, an awarded large-scale collaborative project award 
was or will be transferred to your institution due to a change in 
Principal Investigator or change in institution for the Principal 
Investigator.  
 
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS   

The major research activity of the Principal Investigator (PI) must be 
in the research area of the collaborative project application, and the 
PI is expected to commit an appropriate level of effort to directing 
and managing the operation of the project; a substantial level of 
effort will be necessary to manage projects of the largest magnitude.  
Changes in PI or in lead institution for a large-scale collaborative 
project award must be approved by the NIGMS program director for the 
award in advance.

SPECIAL REQUIREMENTS

COLLABORATIVE PROJECT ORGANIZATION AND RESOURCES:  The elements and 
organization of a large-scale collaborative project remain the same.  
The organizational structure of the collaborative project may have a 
variety of forms depending on the needs of the research problem being 
addressed.  

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 requiring additional funding to enhance the 
efforts of the consortium or to integrate the individual work of a 
participating investigator with the consortium.  Two mechanisms, 
bridging projects and pilot projects, have been designated for this 
purpose.

Bridging Projects

Applications may propose new or continuations of existing bridging 
projects 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.  Requests 
for continuation of existing bridging projects must be justified in 
terms of progress to date as well as future plans.  Bridging projects 
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 efforts that tie, or enhance the 
contribution of, the independent work and expertise of the 
participating investigator to the large-scale collaborative project.  A 
new bridging project should extend the participating investigator’s 
independent work in a new direction(s).  A new 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

New pilot projects may be requested in the renewal application, but 
require strong justification keeping in mind that the award will be in 
a final renewal period.  Pilot projects are intended for investigators 
who do not hold 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 
expertise of the PI of the pilot project 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 to add additional capability to the 
collaborative project by adding new or improved technology or by 
standardizing data among different research teams.  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.  Requests for continuing 
existing core resources must also be justified in terms of progress and 
results achieved to date.  It is expected that each large-scale 
collaborative project will request core resources for continuing 
information collection, coordination, and dissemination.  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.  

Administrative Management Plan

Each large-scale collaborative project award application must provide 
an administrative management plan that includes: an overall description 
of the organization of the large-scale project, the make up and 
responsibilities of the steering committee (including how often and by 
what means they will meet), and how information will flow within the 
project and how it will be integrated into the solution of the 
biological problem being addressed.  It should outline the policies and 
procedures whereby participating and non-participating investigators 
can have access to the collaborative project resources.  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 include 
proposed methods for information dissemination to the scientific 
community, as well as to consortium members.  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 award 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, developed by the 
PI in consultation with the steering committee.  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 on 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, NIGMS requires 
applicants who respond to this RFA to (1) submit a plan for sharing the 
research resources generated through the award and list the 
collaborative project’s record to date on the timing of release of 
shared research resources; and (2) address how they have exercised 
intellectual property rights and describe plans for the future, should 
any be generated through this award, while making such research 
resources available to the broader scientific community.  It is 
expected that resources 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, and 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, as well as the consortium’s record to date.  
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 of research resources and to effective 
management of intellectual property issues will be part of the 
scientific merit review.  The adequacy and record to date 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:

Members of the large-scale collaborative project must disclose in the 
application their ties to profit-making organizations to aid the 
administration of the collaborative project and to assist the NIH 
review process 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.

COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD:  

The following section 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 mechanism, the NIH’s 
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 primary responsibility resides with 
the awardees for the project as a whole.

1. 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 originating from 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.  The PI will chair 
the steering committee. 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. 

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, and also 
subject to the approved sharing of research resources plan and 
intellectual property plan to 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).

2. 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.  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).  Principal Investigators of pilot projects are also 
included as participating investigators.  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.  They must provide a listing of organizational resources that 
will be committed to the project.  Participating investigators will be 
actively involved in the project and interactive with the other members 
of the project.  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 research 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.

3. NIGMS Program Director Responsibilities:  The NIGMS program director 
will be responsible for the normal stewardship of the award.  In 
addition, s/he will serve as a voting member of the steering committee, 
attending all meetings, and will have substantial programmatic 
involvement.  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 will 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.

4. Steering Committee Responsibilities:  A steering committee will 
continue to serve as the governing board of each large-scale 
collaborative project and 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.  Current members 
may continue and additional or replacement members will be selected by 
the PI in consultation with the steering committee and with the 
approval of the NIGMS program director.  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, deal 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.  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.  

5. Advisory Committee Responsibilities:  The advisory committee will 
continue in its role of advising the PI and steering committee.  It 
will be composed of a panel of a minimum of three scientists not 
otherwise associated with the large-scale collaborative project.  The 
members will be appointed by the PI in consultation with the steering 
committee, and with the approval of the NIGMS program director.  The 
NIGMS program director will attend the meetings of the advisory 
committee 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 to provide advice to the PI and 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.

5. 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.

6. 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 by NIH.  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.  The decision of the arbitration panel, by 
majority vote, will be binding.  This special arbitration procedure in 
no way affects the right of an awardee to appeal an adverse action 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

SUBMITTING AN APPLICATION

Applications must be prepared using the most recent PHS 398 research 
grant application instructions and forms (currently rev. 5/2001). 
Applications must have a DUN and Bradstreet (D&B) Data Universal 
Numbering System (DUNS) number as the Universal Identifier when 
applying for Federal grants or cooperative agreements.  The DUNS number 
can be obtained by calling (866) 705-5711 or through the web site at 
http://www.dunandbradstreet.com/ .  The DUNS number should be entered 
on line 11 of the face page of the PHS 398 form. The PHS 398 document 
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.
 
SUPPLEMENTARY INSTRUCTIONS:  Applications in 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 as 
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 below 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. 
Although a substantial level of effort is expected for the PI, NIGMS 
has not set minimum levels of effort; 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.  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.  

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.  
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.  
Note: each participating consortium/contractual organization must 
submit a separate composite budget for both the initial budget period 
(using Form Page 4) and the entire proposed project period (using Form 
page 5).  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, which 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.  Place the budgets for 
consortium components, cores, bridging projects, and pilot projects 
immediately prior to the description of the relevant individual 
component.  For the 06 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 entire project 
period (years 06-10).

Budget justifications and explanations.  Describe the specific 
functions, including the level of effort, of all key personnel, 
including consultants, collaborators, and technical staff.  Provide 
justifications for requested equipment.  For years 07-10 of the 
project, justify any significant increases or decreases in any category 
over the 06 year budget.

BIOGRAPHICAL SKETCHES AND LETTERS OF COMMITMENT:  Biographical sketches 
must be included for 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 participating investigators who are continuing from the 
original funding period, include a paragraph concisely stating the role 
and interaction of the investigator with the large-scale project during 
the original period.  For all participating investigators, including 
the PI, heads of core resources, and Principal Investigators of 
bridging and pilot projects, provide a listing of all other support; 
support for other investigators such as postdoctoral students should 
not be listed.  Highlight 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.

PARTICIPANT AFFILIATIONS:  Applications should include a separate cover 
sheet that lists 1) all participants, including consultants and private 
sector alliances, 2) all the institutional affiliations for each 
participant, 3) their roles on the project and whether new or 
continuing, and 4) the percent effort listed separately for each role.  
This added requirement will facilitate the review of applications.

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 strictly using the straightforward 
format that follows, or may use alternate combined formats for some 
parts of the application, as described below.  Required components of 
all applications are the program summary; progress report; 
administrative and program management plans; a plan for data sharing 
and intellectual property; Cores A (administrative) and B (information 
dissemination and data coordinating); and responses to the 
bioinformatics questions listed below (see Core Resource C – 
Bioinformatics Core) if the optional bioinformatics core is utilized.  
If desired, Core B may be may be combined with an optional 
bioinformatics core.  The program summary and the progress report may 
be combined. The Progress Report section must include the overall 
progress report as well as summary progress reports for the individual 
elements and discussion of how progress on the individual elements have 
contributed to the success of the overall collaborative project.

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 
from that outlined below 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 180 pages.

Program Summary (Required)

Describe the goals and operation of the large-scale project.  Explain 
what major biological problem is being solved and how the approach of 
using a large-scale collaborative agreement is critical to its 
solution.  Explain how progress made and lessons learned have affected 
your choices of approaches selected for the next and final period of 
support.  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 a cohesive overall program. 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 a comprehensive whole.  Discuss how and when information and other 
research resources generated by the collaborative projects will be 
disseminated to the scientific public.  Explain why the ultimate goals 
of this collaborative project could not be achieved simply by support 
of individual investigators.

Progress Report (Required)

Present an overall summary of progress since the inception of the 
collaborative project that has been made on the goals of the large-
scale collaborative project award and overall summaries of progress for 
each of the individual elements, including original elements that are 
not included for the renewal period.  Describe both the accomplishments 
of the large-scale project and the impact they have had within the 
consortium and on the larger relevant scientific community.  Explain 
how progress made thus far has moved the field forward and has brought 
the ultimate goal of the consortium within reach.  Highlight progress 
that could not have been achieved by individual investigator efforts 
alone.  Delineate new research resources produced by the consortium 
that are now available to the research community.  Provide measures of 
the impact of those resources.  For the individual element progress 
reports, list the major accomplishments of each project element and 
indicate its impact on the progress and cohesiveness of the overall 
effort.

Include web hyperlinks to web sites and databases that are products of 
research.  These will be treated like publications.  Reviewers may 
access these sites to assess their quality and impact.  Sufficient 
description of these research resources and their content should be 
included in the application text for a summary evaluation.

Administrative Management Plan (Required)

Describe the structure, organization, and operation of the project and 
explain why and how this plan has evolved over the period of support.  
Discuss changes that have been made during the course of the project, 
including what elements have been dropped and what elements have been 
added.  Describe the organizational framework and provide an 
organizational chart.  Also describe how information will flow within 
the collaborative project.  Explain the role of the steering committee 
in making administrative management decisions.  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 (Required)

Present a project management plan, including milestones, to keep the 
collaborative project moving forward and on track.  Define both yearly 
milestones and what you expect to have been accomplished at the end of 
the last period of support.  Explain the past and planned role of the 
steering committee in project management.  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.  Any new members of the 
advisory committee for the renewal period should not be contacted or 
selected until an award has been made and the names of prospective new 
members should not be included in the application.)

Plan for Termination after Final Period of Support (Required)

Describe how the NIGMS ten-year limit on funding for a large-scale 
collaborative award will affect conduct of the award during the final 
period of support.  Present the plan for an orderly termination of the 
project and how support will be sought if the project or some part of 
it is intended for continuation.  Delineate research resources 
generated by the large-scale project that would be valuable to continue 
beyond the life of the large-scale award and the plan for support of 
these resources.

The program summary, progress report, administrative management plan, 
project management plan, and the plan for termination sections have an 
aggregate page limit of 50 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 (Required – three-page limit)

List and comment on how the sharing of research resources and 
intellectual property issues has been handled in the first period of 
support, specifically indicating the resources that have been shared 
and the timing of their release.  For each element below, indicate if 
this is a change from the initial period of support.  The PI and 
steering committee should (1) present their 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 A: Administrative Core (Required – 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.  Describe 
any changes that were made during the first period of support and their 
rationale.  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 and Dissemination and Data Coordinating 
Core (Required – 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.  Describe any changes 
that were made during the first period of support and their rationale.  
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 and timing 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 and 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 of each for a 
maximum of 20 pages).  

The policies with respect to future dissemination of data and 
computational tools should be explained in the proposal and it is 
recommended, though not required for the renewal applications, that 
they conform to the following principles:

It is recommended that: computational tools developed for analysis, 
visualization, or modeling the data should be freely shared with the 
scientific community as well as the annotated source code; others 
should be free to modify the source code and share the modifications 
with each other; and that the code should be made available to be 
incorporated into commercial products.

The core description must include answers to the following queries, 
whether a separate core or combined with the information dissemination 
and data coordinating core.  For each, describe any changes that were 
made during the first period.

o What are the data release policies and what are the associated 
intellectual property issues?

o How have the data been made available to the scientific community?  
Is there browser access, formats for downloading complete data sets, 
on-line computational aids, etc.?  Will this change for the next phase 
of the project?

o What is the nature and structure of the data?  Describe the work to 
date and the projected plans for ontologies, schema, or other data 
models. 

o What is the underlying structure of the database, e.g., relational, 
object-oriented, etc.?  Will this be continued?

o What is the mechanism to date and the projected mechanism for 
communication (both computational and human) between the distributed 
sites and the database managers?  Are there data liaisons?

o What are the key interacting databases?  How are the data be linked?  
What are the plans for modifying or enhancing those linkages?

o How is progress made available to the public, e.g., are lists of the 
systems being analyzed made available?  Will the same arrangement 
continue or be modified during the next phase of the project?

o What experience in bioinformatics is available in the group and what 
resources can the consortium draw on?  Compare the qualifications and 
experience of the bioinformatics team you expect to have in the next 
phase with the team that you started the project with.

o How has the bioinformatics plan changed and evolved over the initial 
period of support?

Core D:  Scientific Resource Core(s) (Optional - 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), such as services that will be 
provided and to whom and their bearing on productivity and quality of 
the collaborative research effort.  For continuing cores, discuss how 
the direction, management and use of the core has changed and evolved 
over the initial period of support.

Bridging Projects (Optional – five-page limit for each)

Bridging projects will support work in the laboratories of the 
participating investigators.  Indicate whether this is a new or 
continuing bridging project. For continuing projects, report progress 
that has been made and discuss how the project has changed from and 
builds on the initial period of support.  For new and continuing 
projects, describe the 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 for the specific 
aims, background and significance, preliminary studies/progress, and 
research design and methods.  Also include, as applicable, the 
following sections, which do not count against the page limitations for 
the section or the overall page limit: Abstract (one paragraph), Human 
Subjects Research (also see special requirements in the Federal 
citations below), Vertebrate Animals, and Literature Cited.

Pilot Projects (Optional – ten-page limit for each)

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.  It is necessary to justify 
well the use of a pilot project taking into account that the 
collaborative project is entering its final period of support.  
Projects must be described in sufficient detail to permit evaluation 
through the 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; these sections do not count against the page 
limitations for the section or the overall page limit.  There is a 
maximum of three pilot projects allowed per large-scale collaborative 
project.

Summary of Page Limits

o Combined length of the project summary, progress report, 
administrative management plan, the project management plan, and plan 
for termination of funding – 50 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 – 180 pages  

See also the SPECIAL REQUIREMENTS section above for additional 
application guidance and instructions.

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

APPENDICES: Appendices are allowed for the 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/labels.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 application and 
all copies of the 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 3An.12, MSC 6200
Bethesda, MD  20892-6200
 
APPLICATION PROCESSING:  Applications must be received on or before the 
application receipt date listed in the heading of this RFA.  If an 
application is received after that date, it will be returned to the 
applicant without review. 

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and 
funding assignment within 8 weeks.

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the NIGMS.  Incomplete or non-responsive 
applications will not be reviewed.  

Applications that are complete and responsive to the RFA will be 
evaluated for scientific and technical merit by an appropriate peer 
review group convened by the NIGMS in accordance with the review 
criteria stated below.  As part of the initial merit review, all 
applications will:

o Receive a written critique
o Receive a second level review by the National General Medical 
Sciences Advisory Council
 
REVIEW CRITERIA FOR THE OVERALL 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 evaluate the 
application in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals.  The 
scientific review group will address and consider each of the following 
criteria in assigning the application’s overall score, weighting them 
as appropriate for each application. 

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?  Has 
progress been achieved that has moved its field of research forward?  
If the aims of the renewal application are achieved, will the field of 
biomedical science be advanced to a new level at the end of the next 
period of support?  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?

APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the 
scientific aims of the collaborative project?  Do the plans for future 
studies build logically on the progress made to date?  Does the 
applicant acknowledge potential problem areas and consider alternative 
tactics? Is the project management plan adequate?  Is the 
administrative framework appropriate?  Are the requested components, 
such as core facilities, critical to achieving the scientific goals of 
the collaborative project and are they cost effective?  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? 

INNOVATION:  Are the large-scale collaborative project's structure and 
goals novel? Has the work to date been characterized by innovation?  
Are the proposed 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?

INVESTIGATORS:  Is the PI’s major research activity within the research 
area of the collaborative project?  Has the PI proven to be well suited 
for 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 participating investigators well 
chosen for their roles in the collaborative project?  Are the research 
grants of the participating investigators within the area of the 
collaborative project?  Have the investigators functioned effectively 
as a team?  Is the plan to add and delete participating investigators 
to and from the collaborative project satisfactory?  

ENVIRONMENT:  Do the scientific environments in which the work will be 
done contribute to the probability of success?  Are support personnel 
and resources in place to advance the work?  Will the proposed 
collaborative project take advantage of unique features of the 
scientific environments of the component projects?  Is the level of 
institutional support adequate?  Is access to the core facilities 
appropriate?

ADDITIONAL REVIEW CRITERIA FOR THE OVERALL PROJECT: In addition to the 
above criteria, the following items will be considered in the 
determination of scientific merit and the priority score:

o Demonstrated and planned commitment to the project by the PI and the 
members of the steering committee.

o Commitment of the host and participating institutions 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 and record of the leadership to the sharing of research 
resources (including data and information, materials such as cell lines 
and mutant animals, and novel reagents and techniques) generated by the 
large-scale project with the broader scientific community.

O Adequacy of the plans to deal with the intellectual property issues 
for the collaborative project.

o Quality and accessibility of websites and databases available to the 
broader scientific community.

o Adequacy of plans for the termination of the large-scale 
collaborative project award or continuation with other support at the 
end of the final period of support.

REVIEW CRITERIA FOR THE 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.

REVIEW CRITERIA FOR BRIDGING PROJECTS AND PILOT PROJECTS

Reviewers will be asked to discuss the following aspects of each 
bridging and pilot project. 
  
SIGNIFICANCE:  Does this study address an important problem? For 
continuing bridging projects, has the progress to date added 
significantly to the field and served to increase the cohesiveness of 
the large-scale project?  If the aims of the application are achieved, 
how will scientific knowledge be advanced?  Will the proposed studies 
contribute to achieving the goals of the collaborative project?  
Will/does the bridging project tie or enhance the independent work of 
the participating investigator to the collaborative project, or 
will/does the pilot project add an essential missing aspect to the 
collaborative project?

APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of 
the project?  For continuing bridging projects, has the project evolved 
in a logical and compelling fashion? 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?

INNOVATION:  Does the project employ novel concepts, approaches, or 
methods?  For continuing bridging projects, have innovative results 
been achieved to date?  Are the aims original and innovative?  Does the 
project challenge existing paradigms or develop new methodologies or 
technologies?

INVESTIGATOR(S):  Is the investigator appropriately trained and well 
suited to carry out this work?  Is the work proposed appropriate to the 
experience level of the Principal Investigator and other researchers 
(if any)?  For continuing bridging projects, has the Principal 
Investigator proved to be an effective contributor to the overall 
project?

ENVIRONMENT:  Does the scientific environment in which the work 
will/has been 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 CONSIDERATIONS FOR THE OVERALL PROJECT AND ALL 
COMPONENTS

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK:  The involvement of 
human subjects and protections from research risk relating to their 
participation in the proposed research will be assessed.  (See criteria 
included in the section on Federal Citations, below.)
 
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH:  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 in the 
sections on Federal Citations, below.)

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH:  If vertebrate animals 
are to be used in the project, the five items described under Section f 
of the PHS 398 research grant application instructions (rev. 5/2001) 
will be assessed.  

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

RECEIPT AND REVIEW SCHEDULE

Application Receipt Date:         October 19, 2004/October 19, 2005/
                                  October 19, 2007
Peer Review Date:                 February/March 2005/2006/2008
Advisory Council Date:            May 2005/2006/2008
Award Date:                       September 2005/2006/2008

AWARD CRITERIA

Award criteria that will be used to make award 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 impact on the broader scientific community
o adequacy of plans for termination of NIGMS support
o program priorities
o program balance
o availability of funds

REQUIRED FEDERAL CITATIONS 

HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated 
with reference to the risks to the subjects, the adequacy of protection 
against these risks, the potential benefits of the research to the 
subjects and others, and the importance of the knowledge gained or to 
be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 

DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required 
for all types of clinical trials, including physiologic, toxicity, and 
dose-finding studies (phase I); efficacy studies (phase II); efficacy, 
effectiveness and comparative trials (phase III).  The establishment of 
data and safety monitoring boards (DSMBs) is required for multi-site 
clinical trials involving interventions that entail potential risk to 
the participants.   (NIH Policy for Data and Safety Monitoring, NIH 
Guide for Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

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 "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.htm.
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://stemcells.nih.gov/index.asp 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, in the project description and elsewhere in the application as 
appropriate, 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.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:   
The Department of Health and Human Services (DHHS) issued final 
modification to the “Standards for Privacy of Individually Identifiable 
Health Information”, the “Privacy Rule,” on August 14, 2002.  The 
Privacy Rule is a federal regulation under the Health Insurance 
Portability and Accountability Act (HIPAA) of 1996 that governs the 
protection of individually identifiable health information, and is 
administered and enforced by the DHHS Office for Civil Rights (OCR). 
Those who must comply with the Privacy Rule (classified under the Rule 
as “covered entities”) must do so by April 14, 2003 (with the exception 
of small health plans which have an extra year to comply).  

Decisions about applicability and implementation of the Privacy Rule 
reside with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, 
including a complete Regulation Text and a set of decision tools on “Am 
I a covered entity?”  Information on the impact of the HIPAA Privacy 
Rule on NIH processes involving the review, funding, and progress 
monitoring of grants, cooperative agreements, and research contracts 
can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

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 at http://www.cfda.gov/ and is not subject 
to the intergovernmental review requirements of Executive Order 12372 
or Health Systems Agency review.  Awards are made under the 
authorization of Sections 301 and 405 of the Public Health Service Act 
as amended (42 USC 241 and 284)and under Federal Regulations 42 CFR 52 
and 45 CFR Parts 74 and 92. All awards are subject to the terms and 
conditions, cost principles, and other considerations described in the 
NIH Grants Policy Statement.  The NIH Grants Policy Statement can be 
found at http://grants.nih.gov/grants/policy/policy.htm.

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) - Home Page Office of Extramural
Research (OER)
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Bethesda, Maryland 20892
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and Human Services (HHS)
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