Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
National Center for Research Resources (NCRR), (http://www.ncrr.nih.gov)

Title: Mutant Mouse Regional Resource Centers (Limited Competition U42)

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-09-003

Catalog of Federal Domestic Assistance Number(s)
93.389  

Key Dates
Release Date: November 18, 2008
Letters of Intent Receipt Date: N/A
Application Receipt Date: New Date March 18, 2009 (per issuance of NOT-RR-09-007) Original Date: March 3, 2009
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): Not Applicable
Expiration Date: New Date March 19, 2009 (per issuance of NOT-RR-09-007) Original Date: March 4, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Purpose. The National Center for Research Resources (NCRR) invites applications for a limited competition Funding Opportunity Announcement  (FOA)  for the continued support and advancement of the Mutant Mouse Regional Resource Centers (MMRRC). The MMRRC project is expected to facilitate research by identifying, acquiring, evaluating, characterizing, cryopreserving, and distributing mutant mouse strains to qualified biomedical investigators. A regional network of three repositories collectively operates, using a mutually agreed upon, defined set of standard operating procedures to serve the needs of the biomedical research community for transgenic, knockout and other genetically-induced mutant mice. Each center is responsible for importing mice from assigned donating investigators, and establishing banks of cryopreserved sperm, embryos, and related materials for distribution to research investigators. The PI of each MMRRC Center is required to develop a high risk, high return, research pilot 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 reproductive technologies.  The overall objective of this limited competition FOA is to support the continued availability of mutant mice to biomedical researchers in the United States (US). This limited competition FOA will use the U42 cooperative agreement mechanism to continue support for the resource.

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 (NCRR) requests a limited competition to provide continued support for the Mutant Mouse Regional Resource Centers (MMRRCs). The overarching purpose of the research funded by the NCRR is to reduce the societal burden of morbidity and mortality from diverse conditions and diseases, and better understand normal and abnormal biological factors. The resources described by this FOA focus on access to, and providing research resources for, biomedical research. The MMRRC repositories are currently funded as a cooperative agreement (U42), to acquire, and provide mutant mice, sperm, embryos, and embryonic stem cells lines (ES cells lines) to qualified biomedical researchers at research centers, academic institutions, the NIH, and other federal agencies.

The PI of each MMRRC Center is required to develop a high risk, high return, research pilot 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 reproductive 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 three projects awarded as a result of this announcement is $3M 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 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.

Renewal applications will be permitted for 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) 435-0714, Email: GrantsInfo@nih.gov.

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.

The application format is to be that of the PHS 398 as customized for the NIH multi-component cooperative agreement U42 mechanism. A complete application must be received by the NIH Center for Scientific Review (CSR) no later than March 3, 2009. If an application is received after that date, it will be returned to the applicant without review. CSR will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. CSR will not accept any application that is essentially the same as one already reviewed. This rule does not preclude the submission of a substantial revision of an application already reviewed, but such an application must include an introduction addressing the previous critique.   

Supplementary Instructions

Face page. Name of Principal Investigator (PI)

The PI(s) is (are) the individual(s) designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the grant. The applicant organization may designate multiple individuals as PIs who share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PI is responsible and accountable to the grantee organization or, as appropriate, to a collaborating institution, for the proper conduct of the project or program, including submission of all required reports.

When multiple PIs are proposed, use the Face Page (Continued) page to provide items 3a-3h for all PIs. NIH requires one PI to be designated as the “Contact PI” for all communications between the PIs and the agency. The Contact PI must meet the eligibility requirements for PI status in the same way as other PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The Contact PI may be changed during the project period. The Contact PI should be listed in block 3 of Form Page 1 (the Face Page), with additional PIs listed on the Face Page (Continued). All PIs must be registered in the eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

Format Page 2. Key Personnel

List all Key Personnel, giving name, title, and organizational affiliation.

The Research Plan must be organized in the following sections:

A.       Overall Aims, Background, and Significance

B.       Administrative Structure

C.       Research Resource Design and Plan

D.       Research Resource Infrastructure

E.        Literature Cited

F.       Consortium/Contractual Arrangements

G.       Budget and Supplementary Documentation

Sections A-D must not exceed 25 pages.

A.     Overall Aims, Background, and Significance

This application must describe how the overall goals of the program are advanced by the structure of the,MMRRC, the living and cryopreserved mutant mouse strains, cryopreserved sperm and embryos, and the topics of research. The plan must discuss the need to establish an External Advisory Board, and an Internal Advisory Panel that include external and internal advisors, and discuss the following key areas:

i. Enhancing the capacity and evaluating the processes of the MMRRC to engage biomedical researchers and encourage requests for living and cryopreserved, mutant mouse strains, sperm and embryos.

ii. Evaluating and continually improving service delivery and communication with the biomedical research community.

iii. Enhancing the capacity to utilize technologies and improving the quality of the resource’s acquisition, evaluation, characterization, cryopreservation, storage, and distribution of mutant mouse strains, sperm and embryos.

iv. Evaluating and continually maintaining biohazard safety.

v. Evaluating and maintaining adherence to Health and Human Services and NIH guidelines and regulations.

vi. Communicating with the public on recent biomedical research advancements, and providing updates to the research community it serves.

Briefly describe the purpose and history of the,MMRRC and the research communities that they serve.

A progress report summarizing the previous 5-year funding cycle must be included in this section as background to document the development and progress of the MMRRC,including a description of the interactions that occurred with other public and NIH supported mouse repositories, and with the researchers served.

B. Administrative Structure. This section should describe the proposed administrative structure of the project, e.g., PI(s), co-investigators, the proposed Steering Committee(s), other functional committees or special interest groups, other collaborating research support resources, and how these units/components function to support and maintain the research resource plan of the MMRRC, and to maintain communication with other mouse research projects, such as the Knockout Mouse Repository, other NCRR and NIH supported projects and the biomedical research community. Provide the names of key personnel and their functional title. Identify who will be responsible for overseeing the acquisition, evaluation, characterization, cryopreservation, storage, and distribution of mutant mice and cryopreserved germplasm, (i.e., sperm and embryos). Methods used for quality control of specimens should be described. Also, the MMRRC operating protocols should be described. 

C.       Research Resource Design and Plan.

i.        Structure and Approach:

The applicant must propose detailed plans describing the design and development of the MMRRC, to include current and future capacities of the research resource, procedures for acquisition, evaluation, characterization, cryopreservation, and distribution of mutant mice, sperm, and embryos and pathogen screening. The applicant must describe the design of the quality control procedures, data collection, analysis, and diagnostic verification. The design and development of the database and free public homepage should be such that they provide a user-friendly accounting of the resource’s holdings.

ii.      Customer Service

The applicant must describe the current status and future plans of the customer service and public relations. The applicant must describe the two current customer service interfaces of the MMRRC project: the first one is located at each regional center, and the second one, the Informatics, Coordination and Service Center at the Jackson Laboratory funded by a contract. The future plan needs to provide access for biomedical researchers who have technical questions regarding the search or specification of mutant mouse strains, or need assistance with decisions on ordering living mice, or cryopreserved sperm and embryos.  Moreover, the applicant must outline current status and plans on communication, and enhancement of public relations of the research resource with government, private research facilities, and promote services available from the research resource.

iii.     Milestones

The application must present specific milestones that will need to be met in order to accomplish the work set out above in a five-year time frame.

iv.    Principal Investigator

The effective management of a research resource requires a significant commitment by the PI.  The PI of a research resource under this FOA must 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 a fitting level of seniority within the applicant organization, and with appropriate authority.

v.    Management of Integration plans

The applicant must 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 research resource effort, and its management structure, including the integration of the separate components to form an efficient pipeline from a request from a donating investigator to submit a mutant mouse strain to the MMRRC consortium, through the processes of acquiring, evaluating, characterizing, cryopreserving, and distributing high-quality mutant mice to a requesting investigator. The plan should include reporting relationships, and the roles of the key personnel. The plan should also describe how the various components of the proposed research resource effort will be integrated, and how collaborations or subcontracts, if proposed, will be managed.  Coordination of the awardee’s activities with those of the other components of the research resources, as well as with other national and international programs aimed at providing mutant mouse strains, must be described. The recruitment and training of personnel should be discussed.

D.       Evaluation

Procedures should be described for the evaluation of core functioning (e.g., by external and internal advisory boards) and for implementing recommendations resulting from such evaluations. The applicant must describe and propose external evaluation review procedures by external advisors, and internal evaluation review procedures by internal evaluators, and the strategies and processes of implementing action plans upon mutual agreement. [NOTE: To avoid reducing the pool of potential reviewers, applicants should NOT identify prospective board members in the application, or contact them before a funding decision is made.]

E.       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.

F.       Literature Cited

While this section is not included in the page limitation, it is important to be concise and to select only those literature references pertinent to the research resource. List complete literature citations as directed in the PHS 398 Instructions.

G.      Budget and Consortium/Contractual Arrangements

Costs should be budgeted for attendance at an annual meeting to be located in Bethesda, Maryland, scientific meetings, and other key administrative functions.  The applicant must outline an overall cost-recovery program that provides a stepwise plan for a charge-back fee for procurement, distribution and restocking.  All proposed costs and projected cost reductions asked for above must be given in terms of the direct, indirect, and total costs, i.e., the fully loaded costs (including overhead).  The calculated costs must take into account all of the expenses associated with each component activity including those attributable to informatics infrastructure, quality control, management, and data release. The applicant must present a fully justified budget for the work described above.

If multiple institutions are involved, the project will be administered through a traditional consortium/contractual arrangement, and the usual documentation is required.

H.     Supplementary Documentation

Only statements of Institutional Commitment, Letters of Support, letters of collaborations, and other similar documents, if appropriate, should be included in this section.    

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
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:

Barbara J Nelson , Ph.D.
Scientific Review Administrator
Office of Review
National Center for Research Resources
6701 Democracy Boulevard, MSC 4874
Bethesda, MD 20892-4874 (20817 for express mail)
Tel: 301 435 0806
Fax: 301 480 3660
E-Mail: nelsonbj@mail.nih.gov

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 or renewal 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 or renewal 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/archive/grants/policy/nihgps_2003/index.htm.)

6. Other Submission Requirements and Information

Cost Recovery Program

The applicant must outline an overall cost-recovery program that provides a stepwise plan for a charge-back fee for procurement, distribution and restocking.  All proposed costs and projected cost reductions asked for above must be given in terms of the direct, indirect, and total costs, i.e. the fully loaded costs (including overhead).  The calculated costs must take into account all of the expenses associated with each component activity including those attributable to informatics infrastructure, quality control, management, and data release. The applicant must present a fully justified budget for the work described above.

Applicants are advised to include the costs of a two day Annual Meeting of the MMRRC to be held in Bethesda, Maryland in their budget.

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 submitted 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 the 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/.

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 what intellectual property licenses 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). 

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?

Approach: Are the conceptual 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?

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 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)? 

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.

Peer review will emphasize a synthesis of two major aspects of the U42 application: review of the merit of each of the individual research resource centers, and research resource progress compared to a standard of quality in existing broad mouse research resources.

 A.       Review Criteria for the Overall Program

In their written critiques, reviewers will be asked to comment on each of the following criteria and 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 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 resource address an important problem?  If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of this resource on the concepts, methods, technologies, treatments, services, or preventative interventions that drive biomedical research?  Will the overall program have the potential to advance research in a variety of broad scientific areas and fields?                                      

Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the research resource? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Does the overall quality of research services, and adequacy of the proposed resource approaches enhance the overall design of the U42?                                

Innovation:

Does the overall program apply novel concepts and innovative approaches?                                  

Investigator:

Are experienced senior experts and other qualified scientists available to lead the U42 scientifically and coordinate all activities? These may include: tion of the U42,inistrative ir qualified scientists available to lead the U42 scinetifically and coordinate all activities                            

Environment: Does the scientific, organizational, and administrative environment in which the work will be done contribute to the probability of success?

Integration: Is there evidence of Scientific and Administrative integration of the U42?

For Renewal Applications:

B.      Additional Criteria for Renewal Applications

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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.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 U42, 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

An NIH Project Scientist [or “Project Coordinator,” or “Project Collaborator,” or “Intramural Scientist”] will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

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 MMRRC (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.

Section VII. Agency Contacts


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: rallw@mail.nih.gov

2. Peer Review Contacts:

Barbara J Nelson, Ph.D.
Scientific Review Administrator
Office of Review
National Center for Research Resources
6701 Democracy Boulevard, MSC 4874
Bethesda, MD 20892-4874 (20817 for express mail)
Tel: 301 435 0806
Fax: 301 480 3660
E-Mail: nelsonbj@mail.nih.gov

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:Leleslie@mail.nih.gov

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/archive/archive/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.


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