and Human Services (HHS)
EXPIRED
Department of Health and
Human Services
Participating
Organizations
National Institutes of Health (NIH) (http://www.nih.gov)
Components of
Participating Organizations
National Institute of General Medical Sciences (NIGMS) (http://www.nigms.nih.gov)
Title: Program
Projects for Basic Research on Human Embryonic Stem Cells (P01)
Announcement Type
This
is a reissue of RFA-GM-07-002 which was previously released March 22, 2006.
Request For Applications
(RFA) Number: RFA-GM-08-003
Catalog of Federal
Domestic Assistance Number(s)
93.859
Key Dates
Release Date: May
30, 2007
Letters of Intent Receipt Date(s): September 23, 2007
Application Receipt Date(s): October 23, 2007
Peer Review Date(s): March to April 2008
Council Review Date(s): May 2008
Earliest Anticipated Start Date(s): August 1, 2008
Additional Information To Be
Available Date (Url Activation Date): N/A
Expiration Date: October 24,2007
Due Dates for E.O. 12372
Not
Applicable
Additional
Overview Content
Executive Summary
Table of Contents
Part
I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Address to Request Application
Information
2. Content and Form of Application
Submission
3. Submission Dates and Times
A. Receipt and Review and
Anticipated Start Dates
1. Letter of
Intent
B. Sending an Application to
the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review
Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award
Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy
Requirements
A. Cooperative Agreement Terms
and Conditions of Award
1. Principal
Investigator Rights and Responsibilities
2. NIH
Responsibilities
3. Collaborative
Responsibilities
4. Arbitration Process
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research
Objectives
The field of hESC research is in its early stages; the first hESC line was
derived in 1998. While hESC offer a unique opportunity to study human
development and differentiation in vitro, as well as many fundamental questions
in biomedical research, few investigators are trained to use hESC, and the
basic understanding of the molecular and genetic characteristics of hESC
remains limited. Although hESC have tremendous potential for use in
regenerative medicine, clinical applications await a fuller understanding of
hESC biology.
The purpose of this funding opportunity is to stimulate research on the most basic aspects of hESC biology that will lead to a better understanding of the unique properties of hESC, i.e., the ability to self renew and to differentiate into any cell type. NIGMS also seeks to facilitate the use of hESC as a novel human model system to study fundamental research problems within the scope of the mission of NIGMS. While the focus of this initiative is on hESC, comparisons to other pluripotent stem cells (e.g., embryonic germ cells, adult stem cells, or animal embryonic stem cells) may be included. Applicants should visit the NIGMS website at http://www.nigms.nih.gov/ for detailed information on NIGMS areas of research interest. NIGMS does not support research that is targeted to specific organ systems or diseases. The source of hESC that may be used in these studies will be limited to federally approved stem cell lines listed on the Human Embryonic Stem Cell Registry, which can be found at http://stemcells.nih.gov/research/registry/.
This RFA has two main objectives. The first objective is to establish, via core facilities, a research infrastructure to enable and promote research with federally approved hESC lines. The core(s) should also provide resources and expertise necessary to support the R01-like research projects in the program project. An administrative core is not required but may be included. Examples of activities that may be supported by the core(s) include:
1) Studies on improved conditions for the maintenance of hESC in an undifferentiated state and for the differentiation of hESC to other cell types.
2) Characterization of the unique molecular properties of hESC that distinguish them from other stem cell populations (e.g., embryonic germ cells, adult stem cells) and from more differentiated cells.
3) Development of reagents, approaches and tools that will enhance the use of hESC as a model system.
4) Bioinformatics capability for high-throughput data analysis.
5) Training of investigators at the grantee institution to work with hESC and to use them in pilot experiments.
6) Pilot projects using hESC to address a basic biomedical problem.
The second objective is to support a minimum of three related R01-like research projects that focus on a fundamental scientific problem. Examples of research topics within the scope of this RFA include, but are not limited to:
1) The use of hESC as a model system to address basic research problems, such as:
2) The use of hESC as a primary human cell type for evaluating new pharmacologic agents.
See Section
VIII, Other Information - Required Federal Citations, for policies related
to this announcement.
Section II. Award Information
1. Mechanism(s) of
Support
This funding opportunity
will use the P01 Program Project award mechanism.
As an applicant, you will be solely responsible for planning, directing and executing the proposed project.
This
funding opportunity uses the just-in-time budget concepts. It also uses the
non-modular budget format described in the PHS 398 application instructions
(see http://grants.nih.gov/grants/funding/phs398/phs398.html).
A detailed categorical budget for the "Initial Budget Period" and the
"Entire Proposed Period of Support" is to be submitted with the
application.
2. Funds
Available
NIGMS has set aside $6 million in FY2008 to support the total cost of up to three awards. The earliest anticipated start date is August 1, 2008.
The total project period for an application submitted in response to this RFA may not exceed five years. An upper limit of $6.1 million direct costs for the entire five-year period may be requested. Under certain circumstances, with the concurrence of NIGMS staff, additional funds may be requested for major pieces of equipment.
Because the nature and
scope of the proposed research will vary from application to application, it is
anticipated that the size and duration of each award may also vary. Although
the financial plans of NIGMS provide support for this program, awards pursuant
to this funding opportunity are contingent upon the availability of funds and
the receipt of a sufficient number of meritorious applications.
Facilities
and administrative costs requested by consortium participants are not included
in the direct cost limitation, see NOT-OD-05-004.
Section III. Eligibility Information
1. Eligible Applicants
1.A.
Eligible Institutions
You may submit
(an) application(s) if your organization has any of the following
characteristics:
Applicant organizations may submit more than one application as long as they are scientifically distinct.
Foreign institutions are not eligible. However, participating collaborators at foreign institutions may be included through sub-contracts.
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
Previous applicants to RFA GM-07-002 may submit revised applications.
The Principal Investigator will be expected to commit a minimum effort of 20%. Individuals from other institutions are welcome to participate in the P01.
Foreign investigators cannot apply for funds but can collaborate with eligible US applicants if their research is restricted to the use of hESC lines listed on the NIH Human Embryonic Stem Cell Registry at http://stemcells.nih.gov/research/registry/.
2. Cost Sharing or Matching
Not applicable.
The
most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing
3. Other-Special
Eligibility Criteria
Applications must use only hESC lines
listed on the NIH Human Embryonic Stem Cell Registry http://stemcells.nih.gov/research/registry/ in order to be considered for Federal funding. Applicants must check use of
hESC on page 3 of the application and indicate the line(s) to be used and the
NIH identification number. Awards will not be made until access to eligible
hESC is documented.
Section IV. Application and Submission Information
1. Address to Request Application Information
The PHS 398
application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone (301)
710-0267, Email: [email protected].
Telecommunications
for the hearing impaired: TTY 301-451-5936.
2. Content and Form of
Application Submission
Applications
must be prepared using the most current PHS 398 research grant application
instructions and forms. Applications must have a D &B Data Universal
Numbering System (DUNS) number as the universal identifier when applying for
Federal grants or cooperative agreements. The D&B number can be obtained by
calling (866) 705-5711 or through the web site at http://www.dnb.com/us/.
The D&B number should be entered on line 11 of the face page of the PHS 398
form.
The title and number of this funding opportunity must be typed on line 2 of the
face page of the application form and the YES box must be checked.
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 overview section must contain justification for the program project grant mechanism. This section should include a description of the objectives of the program as a whole that 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. This section should specify the administrative and organizational structure(s) that will be used to support and oversee the research and core activities, including arrangements, where needed, to acquire expertise in growing and maintaining hESC and mechanisms to insure that participating investigators meet on a regular basis to exchange information. This section also should include: the face page, an abstract; 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 person months on the program project grant and actual and pending research support from all sources for each project leader (including percent effort devoted to each project). Since NIGMS expects to bring Program Project awardees to the NIH every 1-2 years during the term of these awards to discuss progress and exchange information, travel funds should be budgeted for this purpose. 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. The length of this section should be no more than 25 pages, exclusive of budget and biosketches.
Core(s)
Plans and facilities for a core to grow and maintain approved hESC lines must
be described, along with any proposed efforts for improving growth and culture
conditions of hESC, further characterizing hESC lines, and developing reagents
and tools to enhance the use of hESC as an experimental model system. In
addition, plans to train investigators at the grantee institution to work with
hESC and to use them in pilot experiments should be provided. If pilot projects
are to be included within this core, such plans should be described. Additional
specialized core(s) to support the R01-like component projects may be included.
The description of each core, exclusive of pilot projects, should not exceed 15
pages. Descriptions of Individual pilot projects should be no more than 5 pages.
An administrative core is not required but may be included.
Component Projects
A minimum of three component projects is required. Each individual project
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. The page limit for the research plan for each of the
component projects is 25 pages, the same as the page limit for individual R01
research grant applications. Please note that there is no requirement to submit
this maximum number of pages; concise, articulate applications are encouraged.
3. Submission Dates and Times
Applications must be received on or before the receipt date described below (Section
IV.3.A). Submission times N/A.
3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt
Date(s): September 23, 2007
Application Receipt
Date(s): October 23, 2007
Peer Review Date(s): March to
April, 2008
Council Review Date(s):
May, 2008
Earliest Anticipated
Start Date(s): August 1, 2008
3.A.1.
Letter of Intent
Prospective applicants
are asked to submit a letter of intent that includes the following information:
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
The letter of intent is to be
sent by the date listed at the beginning of this document.
The letter of intent
should be sent to:
Marion M. Zatz, Ph.D.
Division of Genetics and Developmental Biology
NIGMS
45 Center Drive MSC 6200
Building 45, Room Number 2AS-25E
Bethesda, MD 20892-6200
Telephone: (301) 594-0943
Email: [email protected]
3.B.
Sending an Application to the NIH
Applications must be prepared
using the PHS 398 instructions for preparing a research grant application.
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
(U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for
express/courier service; non-USPS service)
Personal deliveries of
applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At the time of submission, two
additional copies of the application and five collated copies of the appendix
material must be sent to:
Helen R. Sunshine, Ph.D.
Chief, Office of Scientific Review
NIGMS
45 Center Drive, Room 3AN.12F, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-2881
Email: [email protected]
Using the RFA Label: The RFA label available in the PHS 398 application
instructions 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.
3.C. Application Processing
Applications
must be received on or before the application receipt date(s) described
above (Section
IV.3.A.). If an application is received after that date, it will be
returned to the applicant without review. Upon receipt, applications will be
evaluated for completeness by the CSR and responsiveness by the NIGMS. Incomplete and
non-responsive applications will not be reviewed.
The
NIH will not accept any application in response to this funding opportunity
that is essentially the same as one currently pending initial review, unless
the applicant withdraws the pending application. However, when a previously
unfunded application, originally submitted as an investigator-initiated
application, is to be submitted in response to a funding opportunity, it is to
be prepared as a NEW application. That is, the application for the funding
opportunity must not include an Introduction describing the changes and
improvements made, and the text must not be marked to indicate the changes from
the previous unfunded version of the application.
The
exception is previous applicants to RFA GM-07-002 who may submit resubmission
applications in response to this announcement. Resubmission
applications must include an Introduction (3 pages) describing the changes and
improvements made, and the text must be marked to indicate the changes from the
previous unfunded version of the application. All instructions in this
announcement must be followed.
Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
This initiative is not subject
to intergovernmental
review.
5.
Funding Restrictions
All NIH
awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The Grants Policy
Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
Only research using hESC lines
that are registered in the NIH Human Embryonic Stem Cell Registry will be
eligible for Federal funding (http://escr.nih.gov).
Pre-award costs
are allowable. A grantee may, at its own risk and without NIH prior approval,
incur obligations and expenditures to cover costs up to 90 days before the
beginning date of the initial budget period of a new or competing continuation
award if such costs: are necessary to conduct the project, and would be
allowable under the grant, if awarded, without NIH prior approval. If specific
expenditures would otherwise require prior approval, the grantee must obtain
NIH approval before incurring the cost. NIH prior approval is required for any
costs to be incurred more than 90 days before the beginning date of the initial
budget period of a new or competing continuation award.
The
incurrence of pre-award costs in anticipation of a competing or non-competing
award imposes no obligation on NIH either to make the award or to increase the
amount of the approved budget if an award is made for less than the amount
anticipated and is inadequate to cover the pre-award costs incurred. NIH
expects the grantee to be fully aware that pre-award costs result in borrowing
against future support and that such borrowing must not impair the grantee's
ability to accomplish the project objectives in the approved time frame or in
any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements
Applicants should budget
for travel of key personnel to scientific meetings sponsored by NIGMS for hESC
P01 grantees. NIGMS expects to hold annual or biennial meetings at the NIH
during the five year award period.
Plan
for Sharing Research Data
The precise content of
the data-sharing plan will vary, depending on the data being collected and how
the investigator is planning to share the data. Applicants who are planning to
share data may wish to describe briefly the expected schedule for data sharing,
the format of the final dataset, the documentation to be provided, whether or
not any analytic tools also will be provided, whether or not a data-sharing
agreement will be required and, if so, a brief description of such an agreement
(including the criteria for deciding who can receive the data and whether or
not any conditions will be placed on their use), and the mode of data sharing
(e.g., under their own auspices by mailing a disk or posting data on their
institutional or personal website, through a data archive or enclave).
Investigators choosing to share under their own auspices may wish to enter into
a data-sharing agreement. References to data sharing may also be appropriate in
other sections of the application.
All
applicants must include a plan for sharing research data in their application.
The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing.
All investigators responding to this funding opportunity should include a
description of how final research data will be shared, or explain why data
sharing is not possible. The reasonableness of the data sharing plan will be
evaluated by reviewers. However, reviewers will not factor the proposed
data sharing plan into the determination of scientific merit or the priority
score.
Sharing Research Resources
NIH policy expects
that grant recipients make unique research resources readily available for
research purposes to qualified individuals within the scientific community
after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan for
sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.
The adequacy
of the resources sharing plan and any related data sharing plans will be
considered by Program staff of the funding organization when making
recommendations about funding applications. The effectiveness of the resource
sharing will be evaluated as part of the administrative review of each
non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm).
See Section
VI.3. Reporting.
Section V. Application Review Information
1. Criteria
Only the review criteria described below will be considered in the review
process. These criteria apply, as appropriate, to the overall program project,
to the core(s), and to the individual component projects.
The following will be considered in making funding decisions:
The overall Program Project, the research core(s), and each subproject will be assigned a priority score. NIGMS may eliminate one or more subprojects that have weak scientific merit and/or are not essential to the integrity of the Program Project. However, a minimum of three subprojects will be required for funding of a Program Project.
2. Review and
Selection Process
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
NIGMS in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
The goals of NIH
supported research are to advance our understanding of biological systems, to
improve the control of disease, and to enhance health. In their written
critiques, reviewers will be asked to comment on each of the following criteria
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 an 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.
Significance: Do the studies in this
Program Project address an important research problem? If the aims of the
application are achieved, how will scientific knowledge or clinical practice be
advanced? What will be the effect of these studies on the concepts, methods and
technologies, treatments, services, or preventative interventions that drive
this field? Will the proposed studies
move the field of hESC research forward?
Approach: Are the conceptual or
clinical framework, design, methods, and analyses adequately developed, well
integrated, well reasoned, and appropriate to the aims of the overall program
project and its component parts? Does the applicant acknowledge potential
problem areas and consider alternative tactics? Do the proposed studies take
advantage of the unique characteristics of hESC?
Innovation: Is the program project
original and innovative? For example: Do the projects challenge existing
paradigms or clinical practice; address an innovative hypothesis or critical
barrier to progress in the field? Do the core(s) or projects develop or employ
novel concepts, approaches, methodologies, tools, or technologies for this
area?
Investigators: Are the investigators
appropriately trained and well suited to carry out this work? Is the work
proposed in the cores and component projects appropriate to the experience
level of the principal investigator and other researchers? Does the
investigative team bring complementary and integrated expertise to the project? Does the PI have the necessary experience,
judgment and expertise to lead and manage the Program Project? Do the investigators have
adequate expertise in the use of hESC? If not, have they identified appropriate
collaborators or described plans to acquire such expertise?
Environment: Does the scientific
environment in which the work will be done contribute to the probability of
success? Do the core(s) and proposed projects benefit from unique features of
the scientific environment, or subject populations, or employ useful
collaborative arrangements? Is there evidence of institutional support?
2.A. Additional Review Criteria:
The scientific merit of the program project grant application as a whole as
well as the synergy of its components and its overall coherence as a program
will be assessed as part of the overall score.
The balance of hypothesis-driven research versus discovery-driven science, as appropriate to the current level of understanding of the basic biology of hESC, will be considered.
In addition to the above
criteria, the following items will continue to be considered in the
determination of scientific merit and the priority score:
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 the Research Plan,
Section E on Human Subjects in the PHS Form 398).
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 will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated (see the Research Plan, Section E on Human Subjects in
the PHS Form 398).
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 Form 398 research grant application instructions will be assessed.
Biohazards: If materials or procedures are
proposed that are potentially hazardous to research personnel and/or the
environment, determine if the proposed protection is adequate.
2.B.
Additional Review Considerations
Budget: The reasonableness of the proposed
budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.
2.C. Sharing
Research Data
Data
Sharing Plan: The reasonableness of the data sharing plan or the rationale for
not sharing research data will be assessed by the reviewers. However, reviewers
will not factor the proposed data sharing plan into the determination of
scientific merit or the priority score. The funding organization will be
responsible for monitoring the data sharing policy.
2.D.
Sharing Research Resources
NIH policy expects that
grant recipients make unique research resources readily available for research
purposes to qualified individuals within the scientific community after
publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
Program staff will be responsible for the
administrative review of the plan for sharing research resources.
The adequacy of the
resources sharing plan will be considered by Program staff of the funding
organization when making recommendations about funding applications. Program
staff may negotiate modifications of the data and resource sharing plans with
the awardee before recommending funding of an application. The final version of
the data and resource sharing plans negotiated by both will become a condition
of the award of the grant. The effectiveness of the resource sharing will be
evaluated as part of the administrative review of each non-competing Grant Progress
Report (PHS 2590). See Section
VI.3. Reporting.
3. Anticipated
Announcement and Award Dates
N/A
Section VI. Award Administration Information
1. Award
Notices
After the peer review of the application is completed, the PD/PI will be able
to access his or her Summary Statement (written critique) via the eRA Commons.
If the application is under consideration for funding, NIH will request
"just-in-time" information from the applicant. For details,
applicants may refer to the NIH Grants Policy Statement Part II: Terms and
Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
A formal notification in the form of a Notice of Award (NoA) will be
provided to the applicant organization. The NoA signed by the grants management
officer is the authorizing document. Once all administrative and programmatic
issues have been resolved, the NoA will be generated via email notification
from the awarding component to the grantee business official (designated in
item 12 on the Application Face Page). If a grantee is not email enabled, a
hard copy of the NoA will be mailed to the business official.
Selection of an application for award is not an authorization to begin
performance. Any costs incurred before receipt of the NoA are at the
recipient's risk. These costs may be reimbursed only to the extent considered
allowable pre-award costs. See Also Section
IV.5. Funding Restrictions.
Prior to award the applicant must demonstrate that appropriate arrangements have been made to obtain federally approved hESC lines.
2.
Administrative and National Policy Requirements
All NIH grant and
cooperative agreement awards include the NIH Grants Policy Statement as part of
the NoA. For these terms of award, see the NIH Grants Policy Statement Part II:
Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
3.
Reporting
Awardees will be required
to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm)
and financial statements as required in the NIH Grants Policy Statement.
We encourage
your inquiries concerning this funding opportunity 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:
1. Scientific/Research
Contacts:
Marion M. Zatz, Ph.D.
Program Official, Genetics and Developmental Biology Division
NIGMS
45 Center
Drive Room
2AS-25E, MSC 6200
Bethesda , MD 20892-6200
Telephone:
(301) 594-0943
Email: [email protected]
2. Peer Review Contacts:
Helen R. Sunshine, Ph.D.
Chief, Office of Scientific Review
NIGMS
45 Center Drive, Room 3AN.12F, MSC 6200
Bethesda, MD 20892-6200
Telephone:
(301) 594-2881
Email: [email protected]
3. Financial or Grants
Management Contacts:
Marcia Cohn
Grants Management Officer
NIGMS
45 Center Drive, Room 2AN.44E, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-3918
Email: [email protected]
Section VIII. Other Information
Required Federal
Citations
Use of Animals
in Research:
Recipients of PHS
support for activities involving live, vertebrate animals must comply with PHS
Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
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).
Sharing
Research Data:
Investigators
submitting an NIH application seeking $500,000 or more in direct costs in any
single year are expected to include a plan for data sharing or state why this
is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their
institutions, on issues related to institutional policies and local IRB rules,
as well as local, State and Federal laws and regulations, including the Privacy
Rule. Reviewers will consider the data sharing plan but will not factor the
plan into the determination of the scientific merit or the priority score.
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 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 funding opportunity 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.
Sharing of
Model Organisms:
NIH is committed
to support efforts that encourage sharing of important research resources
including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.
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 applications for research involving human subjects
and individuals designated as key personnel. The policy is available 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 (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.
NIH Public
Access Policy:
NIH-funded
investigators are requested to submit to the NIH manuscript submission (NIHMS)
system (http://www.nihms.nih.gov) at
PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole or
in part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.
NIH is requesting
that authors submit manuscripts resulting from 1) currently funded NIH research
projects or 2) previously supported NIH research projects if they are accepted
for publication on or after May 2, 2005. The NIH Public Access Policy applies
to all research grant and career development award mechanisms, cooperative
agreements, contracts, Institutional and Individual Ruth L. Kirschstein
National Research Service Awards, as well as NIH intramural research studies.
The Policy applies to peer-reviewed, original research publications that have
been supported in whole or in part with direct costs from NIH, but it does not
apply to book chapters, editorials, reviews, or conference proceedings.
Publications resulting from non-NIH-supported research projects should not be
submitted.
For more
information about the Policy or the submission process please visit the NIH
Public Access Policy Web site at http://publicaccess.nih.gov/ and
view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).
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).
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. For publications listed in the appendix and/or Progress report,
internet addresses (URLs) must be used for publicly accessible
on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for 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
|
| ||||||
|
|
|
Department of Health and Human Services (HHS) |
|
|||
|
NIH... Turning Discovery Into Health® |
||||||