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 on Drug Abuse (NIDA), (http://www.nida.nih.gov)
National Human Genome Research Institute (NHGRI), (http://www.nhgri.nih.gov)
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov)
National Institute of Deafness and Other Communication Disorders (NIDCD), (http://www.nidcd.nih.gov)
National Center for Research Resources (NCRR), (http://www.ncrr.nih.gov)
National Institute of Neurological Disorder and Stroke (NINDS), (http://www.ninds.nih.gov)
National Institute of Dental and Craniofacial Research (NIDCR), (http://www.nidcr.nih.gov)
National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK), (http://www.niddk.nih.gov)
National Institute on Aging (NIA), (http://www.nia.nih.gov)
National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov)
National Institute of Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov)
Title: Development and Improvement of Inbred ES Cell Lines for Use in Generation of Mouse Mutants
Announcement Type
New
Update: The following update relating to this announcement has been issued:
Request For Applications (RFA) Number: RFA-DA-06-009
Catalog of Federal Domestic Assistance Number(s)
93.279, 93.172, 93.242, 93.173, 93.389, 93.853, 93.121, 93.847, 93.848, 93.849, 93.273, 93.865, and 93.866
Key Dates
Release Date: September 16, 2005
Letters of Intent Receipt Date(s): October 20, 2005
Application Receipt Dates(s): November 22 2005
Peer Review Date(s): January-March, 2006
Council Review Date(s): May 17, 2006
Earliest Anticipated Start Date: July 1, 2006
Additional Information To Be Available Date (Url Activation Date):
Expiration Date: November 23, 2005
Applicant Information Meeting:
October 6th, 2005, 2-4 p.m.
NIH main Campus, Bldg 50
1st Floor Conference Center
National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
Due Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive Summary
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 Announcement1. Research Objectives
The purpose of this RFA is to develop C57BL/6 ES cell lines that are efficient for high-throughput gene targeting and in successfully generating mice that can transmit the targeted mutation through the germline, both steps being necessary to create knockout mice on a C57BL/6 background. This RFA is a companion to two other RFAs (HG-05-007 and HG-05-008), all three of which are part of the NIH Knockout Mouse Project (KOMP).
The long-range goal of KOMP is to generate a public resource composed of null mutations, each marked with a useful reporter, in every gene in the mouse genome in the C57BL/6 genetic background. At present, however, it is not clear whether the most efficient strategy to reach this goal is to generate the knockout mutations using gene targeting in the well-tested 129 strain ES cell lines and then breeding the mutation onto the C57BL/6 background or to generate the mutations directly in the C57BL/6 background using either gene targeting in ES cells or gene trapping or transposon-mutagenesis in C57BL/6 mice. RFA-HG-05-007, Completion of a Comprehensive Mouse Knockout Resource is a companion to the present RFA in which NIH is soliciting proposals for large-scale, high-throughput, cost-efficient construction of a comprehensive set of knockout mutations in the mouse genome. The present RFA solicits technology development proposals to improve the C57BL/6 ES cell system to the point at which it can be used in such a high-throughput mutation construction effort. The funding of applications submitted in response to the two RFAs will be dependent on the assessment of the state of the art for knockout construction that is made during the review process. If there are applications submitted in response to RFA-HG-05-007 that propose sufficiently robust and cost-effective plans to make null mutations in C57BL/6 , the need for development of an improved C57BL/6 ES cell system will not be as high as is currently anticipated. On the other hand, if such further technology development is needed, it will be important to the achievement of KOMP's goals to do so rapidly enough to allow the improved C57BL/6 system to be introduced as soon as possible into any high-throughput efforts funded in response to the companion RFA-HG-05-007.
Mouse genetics is a powerful and important tool in the study of human disease. For many years, mouse mutations that mimic human traits have served as a research tool in understanding the genetics underlying human disease or gene function. For this reason, the mouse was designated as a model organism in the initial plan to map and sequence the human genome. That plan noted the value of studying the mouse genome in order to annotate and explore functional genomics in human. In the course of the human genome project, the genetic and physical maps of the mouse were constructed and a high quality sequence of the C57BL/6 genome is now scheduled for completion by the end of 2005. Additionally, the mammalian gene collection (MGC) project (http://mgc.nci.nih.gov/) has produced a total of 15,325 full length cDNA clones, representing 11,501 individual mouse genes. The goal of the MGC mouse cDNA program is to produce, by 2007, at least one full length cDNA clone for each of the ~18,000 currently well defined mouse genes.
With the planned completion of the genome sequence and the full length cDNA collection for mouse, the next high utility genomic resource needed by the mouse research community is a genetic resource that can be used to elucidate gene function in the mouse. To begin planning for such a resource, a meeting was convened at the Banbury Center of the Cold Spring Harbor Laboratory in the fall of 2003, to discuss construction of a publicly available, comprehensive collection of mouse knockouts, i.e. a null mutation in every gene in the mouse genome. The meeting strongly supported the value of a knockout mouse project to generate a library of ES cells comprising a null allele, ideally conditional, for each gene in the genome (Austin, C.P., et al. Nature Genetics 36, 921-924 (2004)). To date, construction of conditional nulls has not been validated in mice in a high throughput procedure. A graduated scheme, represented as a pyramid with three additional tiers, was recommended for the subsequent phenotyping phase of the project. It was envisioned that the project would be international in scope
Since the Banbury meeting, there has been a significant international effort to produce a large number of gene trapped null mutants and to organize efforts to deliver the resource recommended at the Banbury meeting. In March 2005, the NIH held a workshop to assess the status of the field (http://www.genome.gov/15014549). The NIH workshop endorsed the recommendations from the earlier Banbury workshop, that a null mutant resource is a critical tool in dissecting gene function in the mouse and a required complement to the conditional mutant resource being constructed elsewhere. An RFA to implement this recommendation, HG-05-007, is being published simultaneously with this RFA. Additionally, the workshop attendees endorsed the use of C57BL/6 as the strain for development of a null mutation resource because of its wide use in the research community. However, the majority of mutant ES cell lines both previously and currently used to generate knockout ES cells and mice are derived from 129 strains of mice, which are not as commonly used in research for a variety of reasons. This results in an expensive and time consuming process, which exceeds the cost of the knockout production, of backcrossing to another inbred line for experimentation. There have been several reports of using C57BL/6 ES lines for knockout production and germline transmission with success but it is not yet regarded to be as robust and facile as utilizing 129 strains.
The research objectives for this RFA are to develop one or more C57BL/6 ES cell line(s) that can be used efficiently in gene targeting and in generating mice that can efficiently transmit introduced mutations through the germline. The desired cell line(s) should have the following characteristics:
As part of the Knockout Mouse Project (KOMP) Research Network, efforts funded under this RFA will be coordinated with the efforts funded under RFA-HG-05-007, Completion of a Comprehensive Mouse Knockout Resource. NIH anticipates that if one or more robust C57BL/6 ES cell line is developed by a funded project, it (they) can be rapidly introduced into the production lines of the knockout projects so that as much of the new resource as possible will be made on the C57BL/6 background. Thus, it is hoped that the successful applicant(s) will be able to create at least one useful C57BL/6 ES cell line within approximately 2 years, so that the knockout production effort can use it for as long as possible. If the awardee achieves this goal, s/he will be encouraged to use the remaining project funds for further development work, such as obtaining further improvements in the C57BL/6 system or developing other similarly useful ES cells for efficient production of widely used knockout mice on other genetic backgrounds. Determination of future directions for a successful awardee will be done in consultation with the KOMP Research Network.
Timelines and milestones. NIH anticipates that the development of technologies needed to meet this goal will require approximately 2years. A detailed timeline for the project should be presented culminating in the demonstration that the cell line has the characteristics listed above. This detailed timeline should be accompanied by quantitative milestones that address the key scientific and technical challenges central to the effort and are essential for the development of a realistic research plan. They provide a basis for project leaders to make decisions, assess their own progress, set priorities, and redistribute resources when needed. Elaboration of timelines and milestones is primarily the responsibility of applicant, and the quality and utility of the proposed timelines and milestones will be a review criterion, because they reflect the insights and judgment of the applicant concerning key challenges and how best to conduct the research. The timeline and milestones will be essential for use by both the grantee and the NIH for coordinating with the other KOMP initiatives and for assessment of progress toward goals, and by the reviewers for evaluating the proposal.
Data and resource sharing. The successful applicant will be required to transfer all data and resources pertaining to ES cells and mice generated by this initiative to the centers involved with the efforts funded under RFA-HG-05-007, Completion of a Comprehensive Mouse Knockout Resource , to an NIH-funded central repository or an NIH-funded central data base, whichever applies. Therefore, responses to this RFA should propose a specific and comprehensive plan for the rapid release of data and materials resulting from research to develop improved C57BL/6 ES cell lines to the appropriate databases and repositories, respectively. The quality of this plan will be an important criterion in the review of the application, and an appropriate plan for release of data and materials will be made a condition of the awards made as a result of this RFA.
In presenting the data release plan, the release of data to the project's public tracking website must be discussed and should include information for any ES cells or mice that contain gene targeted mutations made during the developmental effort including, but not limited to, information identifying the genes that have been mutated, verification that the construct sequence has been sent to dbGSS, data that confirm a null mutant has been successfully made, information that the ES cell has been deposited in a public resource designated by NIH and its repository location, and finally that a mouse has been made from the mutant ES cell line and its repository location (for the small number that will be made under this RFA as a quality control measure). The materials release plan should account for the release of materials generated as part of the developmental activities and include the release of BAC targeting vectors, mutant ES cells, and any knockout mice, including frozen embryos and sperm samples, derived in the course of the supported work.
Intellectual Property. If, in the course of constructing the desired mouse knockouts, the applicant proposes to use technology covered by third party patent claims, then the applicant must provide evidence that s/he will be able to freely practice the technology. The applicant must also demonstrate that s/he will be free to distribute the knockout ES cells, embryos and mice to the repositories and, ultimately, end-users without any restriction on the repositories' ability to transfer the materials to end-users or end-users' ability to use the materials for research purposes. This plan must include users in both the public and private sectors, although it is recognized that there may be different approaches to the issue of use in the two sectors. A uniform MTA such as the SLA (http://ott.od.nih.gov/NewPages/SimplLtrAgr.pdf) or the UBMTA (http://ott.od.nih.gov/NewPages/ubmta.pdf) will be used for all repositories which receive resources made by this effort to ensure that the resources made by this initiative are available in a manner consistent with the goals of this RFA and with no additional reach through rights to inventions[/discoveries] made by the end users. (See additional information section for issues regarding the intellectual property plan that must be addressed). Applicants with insufficient plans to deal with the intellectual property will not be funded. Applicants are free to patent their discoveries so long as the ES cells, embryos and mice are made available for research purposes in a manner consistent with the goals of this RFA.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Section II. Award Information1. Mechanism(s) of Support
This funding opportunity will use the NIH U01 cooperative agreement award mechanism.
As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.
The NIH U01 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 VI.2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award. Plans for continuation of this program beyond this current funding opportunity are not definite.
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. Plans for funding this initiative beyond the current three year solicitation are indefinite.
2. Funds Available
Up to $1.6 million per year for three years is to be awarded through this RFA.
The participating IC(s) NIDA, NHGRI, NIDCR, NIMH, NCDC, NICHD, NINDS, NCRR, NIDDK, NIAAA, and NIA intend to commit approximately $4.8 million in new grants over three years in response to this RFA. An applicant may request a project period of up to three years and a budget for direct costs up to $1 million dollars per year.
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 will also vary. Although the financial plans of the IC(s) 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 participants are not included in the direct cost limitation, see NOT-OD-05-004.
Section III. Eligibility Information1. Eligible Applicants
1.A. Eligible Institutions
You may submit (an) application(s) if your organization has any of the following characteristics:
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 programs.
2. Cost Sharing or Matching
Cost sharing in not required.
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
Applicants for this RFA must have a proven track record of producing or developing existing ES lines, preferably from C57BL/6 mice and have themselves or collaborators used such lines to create mutant (targeted or gene trapped) germline competent ES cells. Experience must support the proposed goals to develop a robust ES cell line. Documentation of this track record must be included.
Section IV. Application and Submission Information1. 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.
Foreign Organizations
Several special provisions apply to applications submitted by foreign organizations:
Proposed research should provide a unique research opportunity not available in the U.S. NIH policy requires that awards to foreign institutions be made only for unique resources or contributions to research. Therefore, the applicant must provide justification as to the unique contribution an international site will provide for the application (see Section VI.2 below).
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
Letter of Intent Receipt Date: October 20, 2005
Application Receipt Date(s): November 22, 2005
Peer Review Date: January-March, 2006
Council Review Date: May 17, 2006
Earliest Anticipated Start Date: July 1, 2006
Applicant Information Meeting:
October 6, 2005, 2-4:00 p.m.
NIH main Campus, Bldg 50
1st Floor Conference Center
National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
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:
Jonathan D. Pollock, Ph.D.
Genetics and Molecular Neurobiology Research Branch
Division of Basic Neuroscience and Behavioral Research
National Institute of Drug Abuse/NIH/DHHS
6001 Executive Blvd., Rm. 4282, MSC 9555
Bethesda, MD 20892-9555
Telephone: (301) 435-1309
Email: [email protected]
3.B. Sending an Application to the NIH
Applications must be prepared using the research grant applications found in 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 all copies of the appendix material must be sent to:
Rudy Pozzatti, Ph.D . Office of Scientific Review
National Human Genome Research Institute /NIHDHHS
5635 Fisher Lane, Suite 4076
Bethesda, MD 20892
Telephone: (301) 496-7531
FAX: (301) 480-2770
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 NIDA and NHGRI. 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.
Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.
4. Intergovernmental Review
This initiative is not subject to intergovernmental review.
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.
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
Plan for Sharing Research Data
The intent of the Knockout Mouse Project (KOMP) is to produce a publicly available resource of mice carrying null mutations marked with a useful reporter for all mouse genes, eventually in the C57BL/6 genetic background. As part of this goal, data describing the mutant ES cells or mice made as part of the proof of concept for this RFA must be available to all users of the resource. The general NIH data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. However, this policy is insufficient for KOMP as it does not require sufficiently rapid data release. Thus, all investigators responding to this funding opportunity must include a specific and comprehensive plan for the rapid release of data resulting from developmental efforts funded by this RFA. Section I. Research Objectives contains a section entitled Data and Materials Release that addresses the issues that must be addressed in a data sharing plan.
The reasonableness of the data sharing plan will be assessed by the reviewers, who will include this assessment in their determination of scientific merit or the priority score. In addition, the adequacy of the data sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the data sharing activities will be subsequently 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.
Sharing Research Resources
In general, NIH policy requires that grant awardee 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). As the purpose of the Knockout Mouse Project (KOMP) is to generate a comprehensive, publicly available resource for the scientific community, investigators responding to this funding opportunity must include a plan for sharing any research materials generated as proof of concept during the development of improved ES cell lines including plans to deposit them in a repository that will be designated by KOMP specifically for this purpose by the time of funding of these awards. Section I. Research Objectives contains a section entitled Data and Materials Release that addresses the issues that must be addressed in a materials sharing plan for a KOMP component.
The reasonableness of the research materials sharing plan will be assessed by the reviewers, who will include this assessment in their determination of scientific merit or the priority score. In addition, the adequacy of the materials sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the materials sharing will subsequently 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.
Intellectual Property. If, in the course of constructing the proposed mouse knockouts, the applicant intends to use technology covered by third party patent claims, then the applicant must provide evidence that s/he will be able practice such technology. Furthermore, the applicant must also propose a plan that would enable an end user of the ES cells and embryos (and eventually mice) to use the resources in light of any such applicable patents. This plan must include end users in both the public and private sectors, although it is recognized that there may be different approaches to the issue of use in the two sectors. A uniform MTA such as the SLA (http://ott.od.nih.gov/NewPages/SimplLtrAgr.pdf) or the UBMTA (http://ott.od.nih.gov/NewPages/ubmta.pdf) will be used for all repositories which receive resources made by KOMP to ensure that the resources generated by the program will be available in a manner consistent with its goals as described in this RFA and with no additional reach-through rights to inventions/discoveries made by the end users. (See additional information section for issues that must be addressed regarding the intellectual property plan). Applications with unacceptable plans to address intellectual property issues will not be funded. Awardees will be free to patent any inventions, but funding of an award will be dependent upon an acceptable plan to ensure that the ES cells, embryos, mice and other resources generated under this award will be available for research purposes in a manner consistent with the goals of KOMP as described in this RFA. Such a plan will be will be made a condition of the awards made as a result of this RFA.
Section V. Application Review Information1. Criteria
Only the review criteria described below will be considered in the review process.
The following will be considered in making funding decisions:
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 NHGRI 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: Does this study address an important 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, technologies, treatments, services, or preventative interventions that drive this field?
Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?
Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project 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 appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?
Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies 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:
In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:
In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:
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.
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 will be assessed by the reviewers, who will include this assessment in their determination of scientific merit or the priority score. In addition, the adequacy of the data sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. The presence of a data sharing plan will be part of the terms and conditions of the award. NIDA will be responsible for monitoring the data sharing policy. The effectiveness of the data sharing activities will be subsequently 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.
2.D. Sharing Research Resources
In general, NIH policy requires that grant awardee 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). As the purpose of the Knockout Mouse Project (KOMP) is to generate a comprehensive, publicly available resource for the scientific community, investigators responding to this funding opportunity must include a plan for sharing the research materials generated by depositing them in a repository that will be designated by KOMP specifically for this purpose by the time of funding of these awards. Section I. Research Objectives contains a section entitled Data and Materials Release that addresses the issues that must be addressed in a materials sharing plan for a KOMP component.
The reasonableness of the research materials sharing plan will be assessed by the reviewers, who will include this assessment in their determination of scientific merit or the priority score. In addition, the adequacy of the materials sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the materials sharing will subsequently 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
3. Anticipated Announcement and Award Dates
Not applicable
1. Award Notices
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 14 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.
2. Administrative and National Policy Requirements
NIH policy requires that awards to foreign institutions be made only for unique resources or contributions to research. Therefore, the applicant must provide justification as to the unique contribution an international site will provide for the application (see Section IV.2 above).
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. 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).
The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.
Terms and Condition for DA-06-009
2.A. Cooperative Agreement Terms and Conditions 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 UO1, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined above.
The KOMP Research Network will involve four distinct activities (this RFA, further development of the C57BL/6 ES cell system; generation of the knockout mouse resource; a data coordination center; and KOMP repositories); funding of these activities will be solicited by a set of set of four RFAs (DA-06-009; HG-05-007; HG-05-008; and an as-yet unpublished RFA for the KOMP repositories that will be published by NCRR). All components of the KOMP program will be funded by cooperative agreements and a single Steering Committee (section 2.A.3) and a single Panel of Scientific Consultants (section 2.A.4) will serve for all of the KOMP activities. The Terms and Conditions described below are specific for this RFA (DA-06-009), but have been coordinated and made consistent with those described in the other RFAs soliciting components of the KOMP Research Network.
2.A.1. Principal Investigator Rights and Responsibilities
The Principal Investigator will have the primary responsibility for:
The P.I. will have the primary responsibility for defining the details for the ES cell development within the guidelines of RFA DA-06-009 and for performing the scientific activities. The P.I. will agree to accept close coordination, cooperation, and participation of NIDA staff in those aspects of scientific and technical management of the project as described under "NIH Responsibilities . In Section 2.A.2 The P.I. will:Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.
NIH Project Scientists will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. For the KOMP Research Network, a Project Scientist will be appointed from each of the Institutes that is responsible for the participating cooperative agreements, that is, NIDA (RFA DA-06-009), NHGRI (RFA HG-05-007 and RFA-HG-05-008), and NCRR (NIH-funded, KOMP repositories).
For RFA-DA-06-009 (this RFA), the NIDA Project Scientist will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice and coordination. However, the role of the NIDA Project Scientist will be to facilitate and not to direct the activities. It is anticipated that decisions in all collaborative activities will be reached by consensus of the KOMP Steering Committee, of which the PI is a member, and that the NIDA Project Scientist will participate in this process. The NIDA Project Scientist shall participate as a member of the Steering Committee and will have one vote.
The Project Scientist will:
A NIDA Program Director will be responsible for the normal stewardship of this award; this same Program Director may, in addition, be substantially involved as the NIH Project Scientist, as described above.
2.A.3. Collaborative Responsibilities
The Steering Committee will serve as the main governing board of the KOMP Research Network. The Steering Committee membership will include a NIDA appointed Project Scientist administering this RFA, as well as NHGRI and NCRR appointed Project Scientists involved in other RFAs that are considered integral to KOMP. These initiatives include but are not limited to the NIDA RFA DA-06-009, NHGRI RFA-HG-05-007, HG-05-008 and an NCRR initiative for KOMP repositories. The P.I. of each awarded cooperative agreement will also serve on the Steering Committee, as well as additional members that may be added by action of the Steering Committee. Members of the KOMP Working Group will attend the Steering Committee meetings. Government employees outside of KOMP Working Group members may attend, if their expertise is required for specific discussions. The Steering Committee will:
Each full member will have one vote; the total votes of the NIH Project Scientist-members of the Steering Committee will constitute a minority of the votes. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee
2.A.4. Panel of Scientific Consultants
The Panel of Scientific Consultants (PSC) will be responsible for reviewing and evaluating the progress of the members of the KOMP Research Network toward meeting their individual and collective goals. The PSC will provide recommendations to the KOMP Working Group, the Directors of NIDA, NHGRI and NCRR, as well as the Directors of the all other participating institutes, about continued support of the components of the KOMP Research Network. The Panel will be composed of four to six senior scientists with relevant expertise who are not P.I.s of a cooperative agreement involved in the KOMP Research Network. The Panel of Scientific Consultants will be appointed by the Directors of NIDA, NHGRI, and NCRR, with concurrence from the Directors of all other participating Institutes. The membership of the Panel of Scientific Consultants may be enlarged permanently, or on an ad hoc basis, as needed. The Panel of Scientific Consultants will meet at least once a year and by conference call 2 to 3 times per year. During part of this meeting, there will be a joint meeting with the Steering Committee to allow the PSC members to interact directly with the awardees. Annually, the PSC will make recommendations to the NIH regarding progress of the KOMP Research Network and present advice about changes, if any, which may be necessary in the KOMP Research Network program to the Directors of NIDA, NHGRI and NCRR and the Directors of the other participating institutes.
2.A.5. KOMP Working Group
The KOMP Working Group consists of program staff from the each of the NIH institutes supporting the KOMP. The purpose of the KOMP Working Group will be to disseminate information about the progress of the KOMP Research Network to the participating institutes and to provide a forum for the participating institutes to discuss issues related to KOMP. The KOMP Working Group members will report to the Director of their respective IC. The KOMP Working Group will be chaired by the NHGRI Project Scientist for the knockout mouse resource component of the KOMP.
2.A.6. Arbitration Process
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.
2.A.7. Yearly Milestones
Each awardee will be asked to define a set of yearly milestones at the time of the award and to update these milestones annually at the anniversary date. These will be made a condition of the award. In accord with the procedures described above, NIDA may withhold or reduce funds for a project that substantially fails to meet its milestones or to maintain the state of the art in the field.
Each awardee will be asked to define a set of yearly milestones at the time of the award and to update these milestones annually at the anniversary date. These will be made a condition of the award. In accord with the procedures described above, NIDA may withhold or reduce funds for a project that substantially fails to meet its milestones.
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. Awardees will be required to submit periodic (at least every six months) progress reports in a standard format, as agreed upon by the Steering Committee and the Scientific Advisory Panel.
Section VII. Agency ContactsWe 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:
Jonathan Pollock, Ph.D.
Division of Basic Neuroscience and Behavioral Research
Genetics and Molecular Neurobiology Research Branch
National Institute of Drug Abuse/NIH/DHHS
6001 Executive Blvd., Rm. 4282, MSC 9555
Bethesda, MD 20892-9555
Telephone: (301) 435-1309
Email: [email protected]
2. Peer Review Contacts:
Rudy Pozzatti, Ph.D.
Office of Scientific Review
National Human Genome Research Institute/NIH/DHHS
5635 Fisher Lane
Suite 4076
Bethesda, MD 20892
Telephone: (301) 496-7531
FAX: (301) 435-1580
Email: [email protected]
3. Financial or Grants Management Contacts:
Gary Fleming, J.D.
Chief, Grants Management Branch/OPRM
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Room 270
Bethesda, MD 20892
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: [email protected]
Cheryl Chick
Grants Management Officer
Grants Administration Branch
National Human Genome Research Institute/NIH/DHHS
5635 Fisher Lane
Suite 4076
Bethesda, MD 20892
Telephone: (301) 496-7531
FAX: (301) 402-1951
Email: [email protected]
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.
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.
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://www.nih.gov/about/publicaccess/ and view the Policy or other Resources and Tools including the Authors' Manual (http://www.nih.gov/about/publicaccess/publicaccess_Manual.htm).
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 PA 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
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