SUPPORT OF NIGMS PROGRAM PROJECT GRANTS

Release Date:  July 9, 2001

PA NUMBER:  PA-01-116 (Reissued as PA-07-030)
National Institute of General Medical Sciences

PURPOSE

The program project grant mechanism is designed to support research in which the 
funding of several interdependent projects as a group offers significant 
scientific advantages over support of these same projects as individual regular 
research grants.  The purpose of this announcement is to update and clarify the 
policy of the National Institute of General Medical Sciences (NIGMS) regarding 
program project grants and to announce new limits on budgets relevant to future 
submissions of applications.  NIGMS supports research in the broad areas of its 
Divisions: Cell Biology and Biophysics, Genetics and Developmental Biology, and 
Pharmacology, Physiology, and Biological Chemistry.  Program project grants are 
investigator-initiated, but are restricted to areas of special interest to the 
individual divisions within NIGMS (see 
http://www.nigms.nih.gov/about_nigms/about.html for scientific areas of 
interests). Potential applicants are strongly encouraged to contact the NIGMS 
program staff listed at the end of this announcement for guidance about the 
areas appropriate for program project grant applications and the preparation of 
the application itself.  Potential applicants must obtain prior approval for the 
submission of applications that intend to request in excess of $500,000 (direct 
costs) in any project year, in accordance with NIH policy 
(http://grants.nih.gov/grants/guide/notice-files/not98-030.html).  NIGMS will not 
accept applications for which prior approval has not been obtained.  For areas 
not supported by NIGMS, potential applicants are encouraged to contact staff in 
other Institutes.

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 Program Announcement (PA),  Support of 
NIGMS Program Project Grants,  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/.

ELIGIBILITY REQUIREMENTS

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

MECHANISM OF SUPPORT

This PA will use the National Institutes of Health (NIH) P01 award mechanism.  
Responsibility for the planning, direction, and execution of the proposed 
project will be solely that of the applicant.  The total project period for an 
application submitted in response to this PA may not exceed five years.

RESEARCH OBJECTIVES

The program project mechanism is designed to support research in which the 
funding of several interdependent projects as a group offers significant 
scientific advantages over support of these same projects as individual regular 
research grants. Successful program projects generally bring together scientists 
in diverse fields, who would not otherwise collaborate, to apply complementary 
approaches to work on an important well-defined problem.  Since it is not 
unusual for principal investigators of individual research grants to share 
techniques, information, and methods, it is not sufficient that the projects are 
unified by a common theme.  In this regard the burden of proof is on the 
principal investigator, and on each individual project leader, to demonstrate in 
the written application that the program would be much less effective if 
parceled out as a set of independent research grants.  In addition, the program 
project can facilitate the support of essential shared core facilities, e.g., 
major equipment, although the need of a group of investigators for a major piece 
of equipment or a core facility does not in itself justify a program project 
grant.  Administrative cores, except in special, well-justified circumstances, 
will not be allowed.  Further, it is expected that successful program projects 
will establish effective collaborations, particularly in emerging areas of 
research, that extend beyond the life of the program project grant itself.  
Hence, a program project generally has a finite lifetime. 

Normally, a program project consists of three to five individual interdependent 
projects from different investigators.  The scientist designated by the 
applicant institution as the principal investigator bears responsibility for the 
overall scientific leadership and fiscal management of the program project 
grant.  It is expected that each of the collaborating scientists responsible for 
the individual projects will be independent investigators.  Investigators from 
more than one department, administrative unit, or institution (through a 
subcontract mechanism) are commonly included.  The program project grant is not 
intended to be a vehicle for departmental support, nor is the research support 
of a single senior investigator and several postdoctoral and research associate-
level scientists appropriate under this mechanism.  In addition, the program 
project and each individual project must represent a significant effort on the 
part of the participating scientists and be distinct from their other funded 
efforts.  If individuals have substantial support in areas closely related to 
the program project, their support should be folded into the program project.  
If their support cannot be folded in, they may participate as associate members.  
Associate members have full use of, for example, core facilities, and contribute 
to the overall collegiality of the project, but derive no financial support from 
it.  

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and their 
sub-populations must be included in all NIH-supported biomedical and behavioral 
research projects involving human subjects, unless a clear and compelling 
rationale and justification are 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 research involving human subjects should read the 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), 
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm.  The 
revisions relate to NIH defined Phase III clinical trials and require: a) all 
applications or proposals and/or protocols to 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) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

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

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

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

REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS

All investigators proposing research involving human subjects should read the 
NIH policy on education in the protection of human research participants now 
required for all investigators, which is published in the NIH Guide for Grants 
and Contracts, June 5, 2000 (Revised August 25, 2000), available at the 
following URL address:  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.  
A continuing education program in the protection of human 
participants in research is now available online at http://cme.nci.nih.gov/.

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.  
Reviewers are cautioned that their anonymity may be compromised when they 
directly access an Internet site.

APPLICATION PROCEDURES

For applications seeking initial funding in FY 2002, there is an upper limit of 
$5,500,000 direct costs (exclusive of subcontractual indirect costs) for the 
entire five year project period that may be requested in a competing program 
project grant application to the National Institute of General Medical Sciences.  
If fewer than five years are requested, the limit is prorated accordingly.  
Applications that exceed this limit will be returned without review.  For 
program project grants that would be initially funded in the following fiscal 
years, the limits for direct costs are:

FY 2002     $5,500,000
FY 2003     $5,650,000
FY 2004     $5,800,000
FY 2005     $5,950,000
FY 2006     $6,100,000

Under certain circumstances, with the concurrence of NIGMS, staff additional 
funds may be requested and provided for major pieces of equipment.

Applications are to be submitted on the grant application form PHS 398 (rev. 
4/98) and will be accepted at the standard application deadlines as indicated in 
the application kit.  Application kits are available at most institutional 
offices of sponsored research and may be obtained from the Division of 
Extramural Outreach and Information Resources, National Institutes of Health, 
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, 
email: [email protected].

The receipt dates for new, revised, supplemental, and renewal program project 
grant applications are February 1, June 1, and October 1.  The earliest possible 
award dates will be approximately nine months after the receipt date. 
Applications received too late for one cycle of review will be held for the 
next.  

The program project grant application should be structured as a series of 
separate but interrelated project proposals. The following format should be 
used:  

Overall Proposal

An introductory section must contain justification for the program project grant 
mechanism and describe those goals that are not readily attainable through 
individual research project grants.  This section should include: the face page, 
an abstract, a description of the objectives of the program as a whole, which 
describes the relationship of the individual research projects to the entire 
program project, and the special benefits to be achieved by funding as a program 
project grant rather than as a series of individual research grants, a list of 
participating personnel, the consolidated budget for the program project grant 
(summarizing budgets for the component parts and core), a description of 
facilities available, including major instruments and special program resources, 
administrative arrangements for overall scientific leadership, quality control, 
and management of the program project grant, and  a separate, overall listing of 
the proposed percent effort on the program project grant and actual and pending 
research support from all sources for each participating investigator (including 
percent effort devoted to each project). This section must also detail the 
relationship of existing support to the proposed program project and describe 
planned modifications to that support in the event of funding, for example, 
folding in support for related funded research. 

Component Projects

Each individual project of a program project grant should represent both an 
independent and an interdependent research effort, and should be prepared in the 
format of an individual research grant application. The cover page, abstract, 
budget pages, biographical information, a detailed description of the research 
to be conducted, and any justification for human and animal experimentation, if 
applicable, should be included as noted below. The special benefits associated 
with being part of the program project must also be addressed. If support of 
core resources is requested, a separate component describing and justifying 
these should be included.  The page limits for individual R01 research grant 
applications applies to the individual projects.

Applicants planning to submit an investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended/revised version of 
the preceding grant application types requesting $500,000 or more in direct 
costs for any year are advised that he or she must contact the Institute or 
Center (IC) program staff before submitting the application, i.e., as plans for 
the study are being developed.  Furthermore, the application must obtain 
agreement from the IC staff that the IC will accept the application for 
consideration for award.  Finally, the applicant must identify, in a cover 
letter sent with the application, the staff member and Institute or Center who 
agreed to accept assignment of the application.

This policy requires an applicant to obtain agreement for acceptance of both any 
such application and any such subsequent amendment.  Refer to the NIH Guide for 
Grants and Contracts, March 20, 1998 at 
http://grants.nih.gov/grants/guide/notice-files/not98-030.html.

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

Submit a signed, typewritten original of the application, including the 
Checklist, and five 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)

REVIEW CONSIDERATIONS

The initial review of program project grant applications for scientific merit is 
conducted by either the Center for Scientific Review or the NIGMS Office of 
Scientific Review, depending on the subject. Subsequent to the initial review, 
program project grant applications are reviewed by the National Advisory General 
Medical Sciences Council. The applicant should not assume that a site visit or 
applicant interview will accompany the review of a program project grant 
application. Therefore, the application must be sufficiently complete so that it 
can be reviewed without a site visit.  

The individual projects within a program project grant, as well as the program 
project grant as a whole, must meet the same standards of scientific merit as 
those required of regular research project grants. The scientific merit of the 
entire program project grant application, as well as its coherence as a program, 
will be assessed on the basis of the criteria outlined below.

Applications will be assigned on the basis of established PHS referral 
guidelines.  Applications will be evaluated for scientific and technical merit 
by an appropriate scientific review group convened in accordance with the 
standard NIH peer review procedures.  As part of the initial merit review, all 
applications will receive a written critique and undergo a process in which only 
those applications deemed to have the highest scientific merit, generally the 
top half of applications under review, will be discussed, assigned a priority 
score, and receive a second level review by the appropriate national advisory 
council or board.

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

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

(2)  Approach:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project as a whole?  What are the advantages of the program project mechanism 
over a collection of regular research grants (R01s)?  Does the applicant 
acknowledge potential problem areas and consider alternative tactics? 

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

(4)  Investigator:  Is the principal investigator appropriately trained and well 
suited to carry out this work and provide the leadership necessary to ensure 
success of the entire program? Is the work proposed appropriate to the 
experience level of the principal investigator and other researchers?

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

In addition, the scientific merit of each individual project will be assessed 
and a priority score assigned.  This assessment will be based on the scientific 
merit of the individual project based on the published criteria for regular 
research grants 
(http://grants.nih.gov/grants/guide/notice-files/not97-010.html), 
taking into account the additional strength the project gains from 
interactions with other components of the proposed program project grant and its 
potential importance to the success of the total effort.  In this context, it 
may be the case that an individual project may be highly meritorious in the 
context of the entire program project, but not make sense as a stand-alone 
research grant.

AWARD CRITERIA

For those applications assigned to NIGMS, final review and recommendations by 
the National Advisory General Medical Sciences Council and NIGMS program staff 
will take into account the scientific merit of both the individual projects and 
the program project as a whole and the relevance of the project to the interests 
and mission of NIGMS.  It is possible that funding for some of the individual 
projects or core components favorably recommended by the initial review group 
may be deleted by NIGMS staff prior to award of a grant, based on the scientific 
merit of these components or the lack of coherence with the rest of the program 
project. In judging the appropriateness of the application to the mission of the 
programs within NIGMS, Council and staff will consider the budgetary situation 
at the time of funding. In addition, the total support of the principal 
investigator, the group of investigators as a whole, or any individual 
investigator will be considered in funding the entire program project or any 
part thereof.  

INQUIRIES

For further information, applicants are urged to contact the NIGMS program staff 
listed below:

Cell Biology and Biophysics:
Dr. James Cassatt
NIGMS
Natcher Building, Rm. 2AS.19C
Bethesda, MD 20892-6200
(301) 594-0828
[email protected]

Genetics and Developmental Biology: 
Dr. Judith H. Greenberg 
NIGMS
Natcher Building, Rm. 2AS.25
Bethesda, MD 20892-6200
(301) 594-0943
[email protected]

Pharmacology, Physiology and Biological Chemistry
Dr. Michael Rogers 
NIGMS
Natcher Building, Rm. 2AS.49C
Bethesda, MD 20892-6200
(301) 594-3827
[email protected]

For general information, applicants should contact:
Dr. Ann A. Hagan
NIGMS
Natcher Building, Rm. 2AN.24G
Bethesda, MD 20892-6200
(301) 594-3910
[email protected]  

For fiscal matters, applicants should contact:
Mr. Joe Ellis
NIGMS
Natcher Building, Rm. 2AN.32C
Bethesda, MD 20892-6200
(301) 594-5135   
[email protected] 

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance Nos. 
93.862, 93.821, and 93.859. 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 and Federal Regulations 42 CFR 52 and 45 
CFR Parts 74 and 92.  This program is not subject to the intergovernmental 
review requirements of Executive Order 12372 or Health Systems Agency review.

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

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