and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Issuing Organization
National
Center for Research Resources (NCRR), (http//www.ncrr.nih.gov)
Participating Organizations
National
Institutes of Health (NIH), (http://www.nih.gov)
Announcement Type
This is a reissue of RFA-RR-99-001.
Update: The following update relating to this announcement has been issued:
Request For Applications (RFA) Number: RFA-RR-09-002
Catalog of Federal Domestic Assistance Number(s)
93.389
Key Dates
Release Date: November 25,
2008
Letters of Intent Receipt
Date: N/A
Application
Receipt Date: March 3,
2009 (New Date March 17, 2009 per NOT-RR-09-006)
Peer Review Date: June 2009
Council Review Date: October 2009
Earliest Anticipated Start
Date: December 2009
Additional
Information To Be Available Date (Url Activation Date): N/A
Expiration Date: New Date March 18, 2009 (per issuance of NOT-RR-09-006) (Original Expiration Date: March 4, 2009)
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, Review and Anticipated Start Dates
1. Letter of Intent
B.
Sending an Application to the NIH
C.
Application Processing
D. Application
Assignment
4.
Intergovernmental Review
5.
Funding Restrictions
6.
Other Submission Requirements and Information
Section V. Application Review Information
1.
Criteria
2.
Review and Selection Process
A.
Additional Review Criteria
B.
Additional Review Considerations
C.
Resource Sharing Plan(s)
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 National Center for Research Resources solicits new applications from
institutions/organizations to further advance the Mutant Mouse Regional
Resource Center (MMRRC) program. The MMRRC project consists of three centers
that collectively operate to serve the needs of the biomedical research
community for high-quality mutant mice for research in diverse areas of
biomedical research.
Background information:
The MMRRC program was established in 1999 in response to recommendations of the 1998 NIH meeting on Priority Setting for the Mouse Genomics and Genetics Resources (http//www.nih.gov/about/director/reports/mgenom3.htm) and the need to establish repositories to acquire genetically modified mice, establish banks of cryopreserved germplasm, and distribute mutant mice and germplasm to the scientific community.
The MMRRC program cooperatively identifies, solicits and reviews requests from donating investigators for possible acquisition and distribution to qualified biomedical investigators. Once accepted, the mutant mouse strain is assigned to a MMRRC Center. That center obtains mice or germplasm from the donating investigator and the mouse/germplasm is tested for the presence of pathogens and rederived if necessary. Genetic quality control is used to confirm the correct genotype. All strains are cryopreserved using state-of-the-art methods at no cost to the donating investigator. Mutant mice and associated biological materials are distributed to requesting investigators for a small fee. Investigators interested in donating mutant mouse strains or searching for available mutant mice should visit: http://www.mmrrc.org for more information. All mutant mice strains remain the property of the donating investigator.
The MMRRC program collectively has a current census of approximately 1,600 mutant mouse strains maintained as either active breeding colonies, or cryopreserved germplasm in the forms of embryos and sperm. In addition, 27,389 mouse ES cell lines are available for distribution.
Each MMRRC Center serves as a center of excellence in multiple areas, such as mouse husbandry, genetic and genotyping services, mouse genomic manipulation, mouse germplasm preservation, strain rescue, pathology and clinical pathology, or infectious disease diagnostics. Cost effective services in these and others areas are available to the biomedical research community on a collaborative or fee-for-service basis.
The successful applicant who will join the MMRRC program will demonstrate a successful track record of running an established mouse repository that includes expertise with mouse strains and mutant mice in four key areas: 1) Ability to identify, acquire, and evaluate mutant mice for utility in diverse areas of biomedical research; 2) Ability to provide state-of-the-art cryopreservation methods to establish frozen banks of mutant mice and germplasm (i.e., sperm, and embryos); 3) Ability to distribute cryopreserved mutant mice and germplasm upon the request of qualified investigators; and 4) Ability to establish multiple living colonies of mutant mice and distribute the mutant mice to investigators.
The successful new MMRRC Center will serve the local, regional, and national needs of qualified investigators for genetically modified mutant mice. The new Center will be capable of adopting new technologies to increase efficiency and efficacy of repository operations that may include, but are not limited to, the distribution of dried sperm or application of novel or improved assisted reproduction technologies.
Background on Customer Service and Public Relations: The applicant for the new MMRRC Center must describe plans for a user-friendly customer service interface. This plan must provide access for scientists who search for specific mutant mouse lines for research, who have technical questions regarding the search, identification, or specification of a mouse line, or who need assistance with decisions on ordering living mutant mice, or cryopreserved materials (mice, embryos, and sperm), or obtaining live mice from a repository s reanimation service. Moreover, the applicant must also outline plans for developing and enhancing awareness of the MMRRC project using public relations techniques to advertise mice and promote research services that are available from the MMRRC Centers.
Background on Storage: The applicant for the new MMRRC Center must describe plans for state-of-the-art cryopreservation for all imported mutant mouse lines, embryos, and sperm to ensure the highest quality and most secure archive. Describe the storage facilities, current and future capacities of the repository, current expertise for rederivation of mice from cryopreserved sperm and embryos, and the plans for future development.
Background on Quality Control: The applicant for the new MMRRC Center must describe protocols for state-of-the-art quality control measures. Examples of appropriate quality control procedures include accuracy of material tracking, testing of pathogen status, and validation of mutant alleles by genotyping, confirmation of genetic background strain, and monitoring the success of rederivation of mice from embryos and sperm. Evidence of past experience with, and the effectiveness of, the proposed quality control programs should be included. The applicant should describe the steps that will be taken to ensure that the activities of the repository are in compliance with standards for international repositories.
Timelines and Milestones: The applicant for the new MMRRC Center should propose specific milestones that will need to be met in order to accomplish the work set out above in a five-year time frame. Actual milestones for the funded effort will be negotiated before an award is made.
Management Plan: The effective management of a repository project requires a significant commitment by the Principal Investigator (PI). The PI of a large-scale resource project funded under this FOA is expected to devote at least 10% effort to the project. The applicant should have direct experience, knowledge, and hands-on involvement in daily operations. It is expected that this individual will be an established scientist with the appropriate levels of seniority within the applicant institution, and with appropriate authority. The applicant should describe the management plan for the proposed project, and how it will support achievement of the proposed goals and milestones. The application should describe the organization of the proposed repository effort and its management structure, including integration of the separate components to develop an efficient operation, key personnel, section leaders, and reporting relationships. Recruitment, training and retention of personnel should be discussed. The plan should also describe how the various components of the proposed repository effort will be integrated, and how collaborations or subcontracts, if proposed, will be managed. Coordination of the awardee’s activities with other regional, national and international programs aimed at archiving and distributing mutant mice must be described.
Bioinformatics and Database Information: The applicant for the new MMRRC Center must provide a detailed plan describing the bioinformatics tools required for the MMRRC. These include, but are not limited to, the informatics infrastructure, such as the basic Information Technology infrastructure and system administration, the laboratory information management system, and the system for data handling and deposition, plus any informatics that will be used to provide a public interface for describing the nature and status of all repository materials. In all cases, any needed software development should be described in detail, including how it will be made publicly accessible. Additionally, a plan as to how repository data at a MMRRC Center will be transferred to and from the Informatics, Coordination and Service Center (ICSC) is needed. Finally, a description of bioinformatics tools for customer service operations, and linkage to local, regional, and national electronic networks, (e.g., FIMRe - www.fimre.org) will be needed.
Background on Informatics Systems: The ICSC develops, implements, and operates the informatics infrastructure for the MMRRC project. This includes MMRRC central databases, search tools, a free public website (http//www.mmrrc.org/index.html), and customer service to qualified biomedical researchers. The ICSC follows the policy guidelines of the MMRRC Research Consortium (MRC) which serves as the governing board for the group of awards.
The Principal Investigator (PI) of each center is required to develop a high risk, high return, research pilot project that complements the goals and needs of the MMRRC Research Consortium. Examples of projects include, but are not limited to mouse cloning, novel methods of germplasm preservation, health monitoring using biosensors, and assisted reproduction technologies.
See Section VIII,
Other Information - Required Federal Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism of Support
This funding opportunity will use the cooperative agreement (U42) award mechanism.
The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) 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 beyond the current funding opportunity are indefinite.
2. Funds Available
The estimated amount of funds available for support of one project awarded as a result of this announcement is $750,000 direct costs for fiscal year 2010. Future year amounts will depend on annual appropriations.
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 consortium participants are not included
in the direct cost limitation, see NOT-OD-05-004.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
The
following organizations/institutions are eligible to apply:
Applications will be accepted only from institutions that can demonstrate their prior experience in acquisition, cryopreservation and distribution of mutant mice, with a combined inventory of at least 100 mouse strains in the formats of living mice and cryopreserved sperm and embryos. Specifically, new applications must document and demonstrate a past and current track-record of archiving mouse strains, operating a user-friendly database, managing an efficient, high quality customer service operation, and distributing high-quality sperm, embryos and live mice. The application should also describe past activities and future plans related to community outreach, training, and advertising the resource. Finally, competitive applications must discuss the general approach and strategies to be used to achieve the proposed repository and distribution goals of the MMRRC Research Network.
If an institution with substantial repository expertise and infrastructure lacks one or more of the required skills or capabilities listed, collaboration with a partner institution may provide the necessary expertise for a successful and fully responsive proposal to this FOA. A single institution may not submit more than one application.
However, Institutions with a current MMRRC U42 award are not eligible to apply for this FOA.
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her 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.
More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
2. Cost Sharing or Matching
This program does not require cost sharing as defined in the current NIH Grants Policy Statement.
3. Other-Special Eligibility Criteria
Applicants are not
permitted to submit a resubmission application in response to this FOA.
Applicants are not permitted to submit renewal applications in response to this FOA.
Applicants may not submit more than one application.
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 in item (box) 2 only
of the face page of the application form and the YES box must be checked.
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a 3h for all PD/PIs. NIH requires one PD/PI be designated as the contact PD/PI for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the Contact PD/PI, et. al. The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.
All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
Additional information is available in the PHS 398 grant application instructions.
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: N/A
Application Receipt Date: March 3, 2009 (New Date March 17, 2009 per NOT-RR-09-006)
Peer
Review Date: June 2009
Council
Review Date: October 2009
Earliest Anticipated Start Date): December
2009
3.A.1.
Letter of Intent
A letter of intent is not required for the
funding opportunity.
3.B. Sending an
Application to the NIH
Applications
must be prepared using the forms 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:
Dr. John Glowa, Ph.D.
Office of Review
National Center for Research Resources
One Democracy Plaza, Room 1078
6701 Democracy Boulevard, MSC 4874
Bethesda, MD 20892-4874 (U.S. Postal Service Express or
regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Telephone: (301) 435-0807
FAX: (301) 480-3660
Email: [email protected]
3.C. Application
Processing
Applications
must be received on or before the application
receipt date described above (Section IV.3.A.). If an application is received after
that date, the application may be delayed in the review process or not
reviewed. Upon receipt, applications will be evaluated for completeness
by the CSR and for responsiveness by the reviewing Institute. Incomplete
and/or 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.
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 NIH Grants
Policy Statement.
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 award if such
costs: 1) are necessary to conduct the project, and 2) 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 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 and Information
Applicants are advised to include the costs of an Annual Meeting of the MMRRC to be held in Bethesda, Maryland in their budget.
Technology Transfer
The MMRRC has worked with the community to develop several template Material Transfer Agreements (MTAs) that are used for both transferring mouse stocks in and out of the MMRRC repository. These MTAs can be found on the following web link http://www.mmrrc.org/about/mtaBkgrnd.html. These MMRRC MTAs have also been developed with MMRRC institutional officials as well as with the NIH technology transfer community. The provisions of these MMRRC MTAs are modeled after the language found in the NIH Simple Letter Agreement, thus making the language widely accepted by MMRRC users. The MMRRC is also moving towards a more paperless MTA processing system by adopting the use of a click-on Conditions of Use Statement, currently found on the MMRRC web site: http://www.mmrrc.org/cou/MMRRC_cou_standard.html. Beginning soon, the MMRRC will begin distribution of allowable mouse lines to for-profit institutions. Each MMRRC institution is strongly encouraged to consult with their respective technology transfer office or appropriate office for their institution to determine the intellectual property licenses that may be necessary to carry out the goals of the MMRRC.
Authorization and Consent"
(a) The Government authorizes and consents to all use and manufacture of any invention described in and covered by a United States patent in the performance of this Cooperative Agreement at all tiers.
Notice and Assistance Regarding Patent and Copyright Infringement.
(a) The Grantee shall report to the Program Director, promptly and in reasonable written detail, each notice or claim of patent or copyright infringement based on the performance of this Cooperative Agreement of which the Grantee has knowledge.
(b) In the event of any claim or suit against the Government on account of any alleged patent or copyright infringement arising out of the performance of this Cooperative Agreement or out of the use of any supplies furnished or work or services performed under this Cooperative Agreement, the Grantee shall furnish to the Government, when requested by the Program Director, all evidence and information in possession of the Grantee pertaining to such suit or claim. Such evidence and information shall be furnished at the expense of the Government except where the Grantee has agreed to indemnify the Government.
(c) The Grantee agrees to include, and require inclusion of, this clause in all sub-awards and subcontracts at any tier for supplies or services (including construction and architect-engineer sub-awards and subcontracts and those for material, supplies, models, samples, or design or testing services).
Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information".
Research Plan Page Limitations
25 page Research Plan limit
Appendix Materials
All paper PHS 398 applications must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Resource Sharing Plan(s)NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.
Section V. Application Review Information
1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
Only
the review criteria described below will be considered in the review process.
2. Review and Selection Process
Applications
that are complete and responsive
to the FOA will be evaluated for scientific and technical merit by an appropriate peer review
group convened by The National Center for Research
Resources and in accordance with NIH peer review
procedures (http://grants1.nih.gov/grants/peer/),
using the review criteria stated below.
As part of the scientific peer review, all applications will:
The following will be considered in making funding decisions:
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, and weighted 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 meritorious 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?
Does the proposed high risk, high return, pilot project complement the needs of the MMRRC consortium?
Will the proposed plan to enhance awareness of the MMRRC project promote the availability of mutant mice, specialized services, and research tools?
Do the proposed interactions and coordination with the other MMRRC Centers promote sharing, reduce overlap, and increase access to existing mutant mice?
Will the proposed effort significantly increase the availability of mutant mice to the scientific community?
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? For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs?
Will the proposed plan and reasonableness of the time lines for the MMRRC Repository achieve the following goals?
Establish a functional mouse repository during the first year of funding that is capable of:
1. Acquiring a minimum of 100 mutant mouse strains.
2. Establishing banks of cryopreserved sperm and embryos for 100 mutant mouse strains.
3. Distributing 100 strains of living mutant mice, 25 strains of cryopreserved sperm and embryos to qualified investigators.
4. Establishing a high quality customer service function that assists investigators in their search for mutant mice, including technical advice on the appropriate germplasm format, and ordering instructions.
5. Coordinating activities with the
other MMRRC Centers and other mouse projects with a goal of increasing the
availability of mutant mice for research on the genetic basis of human disease
and diverse other disciplines.
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?
Does the proposal include innovative elements beyond the requested elements? Examples include but are not limited to assisted reproductive technologies (ARTS) for mice, mouse sperm preservation using evaporative drying, intracytoplasmic sperm injection, artificial insemination, and other technologies that might increase the likelihood of innovativeness and success of the MMRRC project?
Does the proposed high risk, high return, pilot project complement the needs of the MMRRC consortium?
Investigators: Are the PD/PI(s) and other key personnel 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 PD/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)?
Do the track records for the proposed PI and other key personnel indicate a high level of experience and expertise in establishing and operating a state-of-the-art repository for acquisition, cryopreservation and distribution of mutant mice and associated biological materials?
Environment: Do(es) the scientific environment(s) 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?
In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the priority score.
Center Grants: Note that the review criteria must be modified to reflect the Regulations at 42 CFR PART 52a.5 NATIONAL INSTITUTES OF HEALTH CENTER GRANTS). Please include the following information.
NIH considers the following in evaluating Center grant applications:
Other factors which the awarding IC considers appropriate in light of its particular statutory mission
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 rating:
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 on Human Subjects in the PHS 398 instructions).
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 on Human
Subjects in the PHS 398 instructions).
Care and Use of Vertebrate Animals in Research: If
vertebrate animals are to be used in the project, the five points described in
the Vertebrate Animals section of the Research Plan 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. Resource Sharing Plan(s)
When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.
3. Anticipated Announcement and Award
Dates
January 2010
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.
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.
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).
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.
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 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 below.
2. A.1. Principal Investigator Rights and
Responsibilities
The
Principal Investigators will have primary and lead responsibilities for the
project as a whole, and agree to accept close assistance, advice, coordination,
and collaborate with the NCRR Project Scientist and other awardees. The
responsibility for planning, direction, and execution of the proposed project
will be solely that of the Principal Investigators. The PIs will be responsible
for defining the details for acquiring, collection, archiving and dissemination
of mutant mice, animal germplasm, and related biological materials.
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.
2. A.2. NIH Responsibilities
The
NIH NCRR Project Scientist will have substantial programmatic involvement that
is above and beyond the normal stewardship role in awards. He/She provides
technical assistance, advice, coordination, and/or other functions above and
beyond the usual level of program stewardship of the award. He/She participates
in all meetings of the MRC as a voting member of the MRC, attends major
meetings of the subcommittees, and should be informed on all major
interactions.
Additionally, a NIH NCRR Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
2.A.3. Collaborative Responsibilities
The
NCRR Project Scientist and awardees are responsible for forming the MMRRC
Research Consortium (MRC), which serves as the governing board for the group of
awards, as defined below. The MRC members are responsible for reviewing the
plans for development and operation of the MMRRCs as proposed in the individual
applications of awardees. The MRC members will develop and use uniform
procedures for quality control, acquisition of mutant mice, mouse husbandry,
maintenance of animal facilities, shipping and receiving animals, germplasm
cryopreservation, reconstitution of embryos and gametes by rederivation, phenotypic
characterization, embryo and gamete quality control, maintenance of local
electronic databases, administrative direction, and reporting procedures. The
MRC will also review and approve the operating procedures proposed by
individual awardee organizations, to ensure they are compatible with the
overall goals of the RFA. The MRC is also responsible for selecting members of
the External Steering Committee (SC) to the Mutant Mouse Regional Resource
Centers (see below).
The MRC voting members will consist of the Principal Investigator (PI) of each MMRRC, and the NCRR Project Scientist. Additional members can be added by consensus of the MRC. The structure of the MRC should be established at the first meeting as noted below. The Chair of the MRC will be responsible for coordinating MRC activities. The NCRR Project Scientist will be responsible for approving the agenda and minutes. Subcommittees will be established by the MRC, as it deems appropriate. The NCRR Project Scientist will serve on subcommittees as he/she deems appropriate.
At its initial meeting, the MRC will elect a chairperson, who must not be the NCRR Program Official or NCRR Project Scientist. The MRC will determine whether additional MRC representation is required, or if standing or temporary committees are needed. Depending on availability of appropriate expertise, the Steering Committee could be constituted as a sub-committee of the MRC.
The MRC will meet at least three times in the first year to plan strategies, develop and approve operating procedures, and to evaluate progress. The initial meeting will be held as soon as possible after funding. Meetings may be held via teleconference, video conference, or in person at convenient locations. These meetings will focus on coordinating the activities of the participating centers, reviewing established and new policies and priorities. The NCRR Program Officer will participate in discussions at these meetings.
The NCRR Program Official will assure that operating policies are acceptable to the NCRR. An arbitration system, as detailed below, will be available to resolve disagreements between awardees and NCRR staff. Decisions such as whether to accept live animals, cryopreserved gametes, embryos and/or other germplasm formats, or to distribute live animals or only cryopreserved germplasm will be determined by the MRC.
Steering Committee members may include expert researchers
with broad expertise in key disciplines needed for successful operations, such
as mouse biologists, pathobiologists, molecular geneticists, and
cryobiologists. When and if additional expertise is needed, experts can be
recruited with the concurrence of the MRC and NCRR Program Official.
Each full member will have one vote.
Awardee members of the Steering Committee will be required to accept and
implement policies approved by the Steering Committee.
2.A.4. 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.
3. Reporting
Awardees
will be required to submit the Non-Competing
Continuation Grant Progress Report (PHS 2590) annually and financial
statements as required in the NIH Grants
Policy Statement.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
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:
William F. Rall,
Ph.D.
Division of Comparative Medicine
National Center for Research Resources
6701 Democracy Blvd, Room 946
Bethesda, MD 20892-4874
Telephone: (301) 435-0744
FAX: (301) 480-3819
Email: [email protected]
2. Peer Review Contacts:
Dr. John Glowa,
Ph.D.
Office of Review
National Center for Research Resources
One Democracy Plaza, Room 1078
6701 Democracy Boulevard, MSC 4874
Bethesda, MD 20892-4874 (U.S. Postal Service Express or
regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Telephone: (301) 435-0807
FAX: (301) 480-3660
Email: [email protected]
3. Financial or Grants Management Contacts:
Leslie Le
Grants
Management Officer
National Center for Research Resources
Office of
Grants Management
6701
Democracy Boulevard
Room
1051-MSC 4874
Bethesda, MD 20892-4874
Phone:
301-435-0856
Fax:
301-480-3777
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).
Data and Safety Monitoring Plan:
Data
and safety monitoring is required for all types of clinical trials, including
physiologic toxicity and dose-finding studies (phase I); efficacy studies
(Phase II); efficacy, effectiveness and comparative trials (Phase III).
Monitoring should be commensurate with risk. The establishment of data and
safety monitoring boards (DSMBs) is required for multi-site clinical trials
involving interventions that entail potential risks to the participants (NIH
Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
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.
Policy for Genome-Wide Association Studies
(GWAS):
NIH is interested
in advancing genome-wide association studies (GWAS) to identify common genetic
factors that influence health and disease through a centralized GWAS data
repository. For the purposes of this policy, a genome-wide association study is
defined as any study of genetic variation across the entire human genome that
is designed to identify genetic associations with observable traits (such as
blood pressure or weight), or the presence or absence of a disease or
condition. All applications, regardless of the amount requested, proposing a
genome-wide association study are expected to provide a plan for submission of
GWAS data to the NIH-designated GWAS data repository, or provide an appropriate
explanation why submission to the repository is not possible. Data repository
management (submission and access) is governed by the Policy for Sharing of
Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/
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.
Inclusion of Women And Minorities in Clinical Research:
It
is the policy of the NIH that women and members of minority groups and their
sub-populations must be included in all NIH-supported clinical research projects
unless a clear and compelling justification is provided indicating that
inclusion is inappropriate with respect to the health of the subjects or the
purpose of the research. This policy results from the NIH Revitalization Act of
1993 (Section 492B of Public Law 103-43). All investigators proposing clinical
research should read the "NIH Guidelines for Inclusion of Women and
Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical
Research:
The
NIH maintains a policy that children (i.e., individuals under the age of 21)
must be included in all clinical research, conducted or supported by the NIH,
unless there are scientific and ethical reasons not to include them.
All
investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as
participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject
Participants:
NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH 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 Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them
their final, peer-reviewed manuscripts that arise from NIH funds and are
accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/),
to be made publicly available no later than 12 months after publication. As of
May 27, 2008, investigators must include the PubMed Central reference number
when citing an article in NIH applications, proposals, and progress reports
that fall under the policy, and was authored or co-authored by the investigator
or arose from the investigator’s NIH award. For more information,
see the Public Access webpage at http://publicaccess.nih.gov/.
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 FOA 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. 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.
Loan Repayment Programs:
NIH
encourages applications for educational loan repayment from qualified health
professionals who have made a commitment to pursue a research career involving
clinical, pediatric, contraception, infertility, and health disparities related
areas. The LRP is an important component of NIH's efforts to recruit and retain
the next generation of researchers by providing the means for developing a
research career unfettered by the burden of student loan debt. Note that an NIH
grant is not required for eligibility and concurrent career award and LRP
applications are encouraged. The periods of career award and LRP award may
overlap providing the LRP recipient with the required commitment of time and
effort, as LRP awardees must commit at least 50% of their time (at least 20
hours per week based on a 40 hour week) for two years to the research. For
further information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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