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:  Informatics, Coordination and Service Center for the Mutant Mouse Regional Resource Centers (U42)

Announcement Type
New

Update: The following update relating to this announcement has been issued:

Request For Applications (RFA) Number: RFA-RR-10-006

Catalog of Federal Domestic Assistance Number(s)
93.389

Key Dates
Release Date: July 15, 2010
Letters of Intent Receipt Date(s): Not Applicable  
Application Receipt Dates(s): October 7, 2010 
Peer Review Date(s): December 2010 
Council Review Date(s): May 2011 
Earliest Anticipated Start Date: July 2011
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: October 8, 2010

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
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. Dispute Resolution 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 MMRRC consortium consists of four repositories (University of North Carolina, University of California, Davis, University of Missouri and The Jackson Laboratory) that collectively operate to serve the needs of the biomedical research community for high-quality mutant mouse strains for research in diverse areas of biomedical research.  The MMRRC consortium’s mission is to acquire, preserve, characterize, and distribute genetically-altered mice, and information describing their characteristics, utility and other features to qualified biomedical scientists and organizations for the purpose of supporting biomedical research. Biomedical investigators and institutions are encouraged to donate mutant mouse strains to the MMRRC. Strains are distributed to qualified biomedical investigators in the forms of frozen embryos, spermatozoa, embryonic stem (ES) cell lines, or as living mice for noncommercial, academic research purposes only. The MMRRC program collectively has a current census of approximately 2,300 mutant mouse strains maintained as either active breeding colonies, or cryopreserved germplasm in the forms of embryos and sperm. In addition, more than 29,000 mouse ES cell lines are available for distribution.

The MMRRC consortium repositories are currently funded as cooperative agreements (U42), to acquire, and provide mutant mice, sperm, embryos, and ES to qualified biomedical researchers at research centers, academic institutions, the NIH, and other federal agencies.  In addition to the four regional repository facilities, the MMRRC has an information coordinating center which provides essential informatics and coordinating services to the MMRRCs and allows the consortium to function as a single resource to the biomedical research community. The functions of the information coordinating center include a public website portal and customer service center to facilitate interactions with biomedical investigators, informatics services, database activities, an archive of MMRRC documents and files, and coordination of requests to donate a mouse strains to the MMRRC or order mouse strains from the MMRRC. Currently the MMRRC information coordinating center is supported under a contract, at the JAX.  As the contract ends August 31, 2011, NCRR is planning to replace the functions of the JAX mutant mouse informatics coordinating center with an entity supported through a U42 cooperative agreement mechanism. As such, the NCRR is soliciting applications from institutions/organizations to continue the operation of and to further develop and implement the ICSC component of the MMRRC consortium.

The successful applicant will acquire all of the existing data from the current holder of the MMRRC informatics coordinating center, replacing and restructuring it with an improved foundation that is able to effectively assume the responsibilities of the ICSC and successfully fulfill its role in the MMRRC program.  As such, the successful applicant must have a demonstrated track record of running an established rodent informatics coordinating and service center that includes recognized expertise with rodent strains and knowledge of managing a national animal resource facility, including a customer service component. The current holder of the MMRRC informatics coordinating center is eligible to apply.

The newly established ICSC is expected to provide essential informatics and coordinating services to the centers of the MMRRC and to biomedical researchers by providing the following:

1)     Acquiring all data from the currently existing NCRR-supported MMRRC informatics coordinating center. Applicants should present plans to acquire all data, information and electronic files from the current holder of the mutant mouse informatics coordinating center and transfer to the grantee's state-of-the-art website, database, and informatics systems.  These data should include copies of existing databases, database schemas, websites, and style sheets developed for the MMRRC.  A transition plan should describe the project schedule from the current holder to the new ICSC system.

2)     Provide and manage a free, public MMRRC website. The ICSC is expected to provide the following capabilities and information:

a)     State-of-the-art search function that allows investigators to query the catalog of MMRRC mutant mouse strains, and view, select, and order mice, cryopreserved germplasm, and/or embryonic stem cell lines.

b)    Provide investigators a link to the detailed information for each MMRRC strain, including origin, utility, genotypic and phenotypic characteristics, strain background, colony and husbandry management, genotyping, publications in the scientific literature, licensing, availability, pricing, and links to the Mouse Genome Informatics (MGI) database and other public databases providing information of each strain.

c)     The website should provide up-to-date information and press releases on the latest proceedings at MMRRC. New strains should be marketed on the front page and should be labeled with NEW in the catalog.  Similarly, lines that are to be discontinued as live colonies will be marketed on the front page to notify investigators of the upcoming change in availability status in case they would like to order mice while the live colony still exists.

d)    On-line application form accessible from the public MMRRC website that allows Donating Investigators to input information on the genetic, phenotypic and other characteristics of a strain proposed for acquisition by the MMRRC.

e)     Background information on the MMRRC program and links to other relevant public mouse strain databases.

3)     Establish, maintain, and regularly update a central database. The ICSC is expected to  provide the following capabilities, information and features:

a)     A list of every strain accepted by the MMRRC repositories. The grantee is expected to use standard scientific nomenclature for all MMRRC strains and must register strains in the MGI database at JAX (http://www.informatics.jax.org/).  The catalog of the MMRRC strains must contain information on the mutated genes, the origin of the mouse strains, the genetic background, the genotypic and phenotypic information available on the strains, the list of publications on the particular strain, and the licensing, availability, and pricing as well as colony and husbandry management of the strain, etc.

b)    Track strains assigned to each MMRRC repository and the completion of each step of acquisition process. When all steps are completed, the grantee is expected to authorize the MMRRC repository to begin distributing the strain to Requesting Investigators.

c)     Curation of strain information for all of the accepted MMRRC strains in the repository.

d)    Provide a means and appropriate security for each MMRRC to update information in the central database, and track who and when the update was made.

e)     Provide a means for an investigator to register interest in a strain that has been accepted by the MMRRC, but is not yet available for distribution.

4)     Establish and manage a Customer Service Center and Public Relations Activities. The grantee must provide a technical service function that can answer questions from investigators regarding the availability and ordering of strains, submission of strains, and other information in a timely manner. Access by e-mail, telephone, facsimile, and mail should be provided.  The ICSC is required to establish an effective marketing program as part of its Customer Service Office aimed at increasing the awareness of the scientific community regarding the MMRRC, and generating a plan to identify and recruit into the MMRRC newly-generated mutant mouse lines that are valuable to the scientific community.

5)     Processing of orders for MMRRC strains. The ICSC is expected to be the initial contact for all orders from Requesting Investigators. Upon receiving an order for a strain, the grantee is required to request a signed Material Transfer Agreement (MTA) and Conditions of Use (COU) from the Requesting Investigator and transmit the MTA, COU and order to the Center holding the strain. If necessary, the ICSC must send weekly e-mail reminders to the Requesting Investigator to ensure timely fulfillment of orders. Additionally, the ICSC is required to maintain a file of the final signed MTAs and COUs received from Donating Investigators and Requesting Investigators.

6)     Review applications from Donating Investigators of strains proposed for acquisition by the MMRRC. The ICSC is required to review applications for completeness, determine if the strain has been deposited in another public repository, prepare a file containing detailed information of the characteristics and utility of the strain; and assign scientific review of the application to one of the MMRRC Centers at least 2 weeks prior to the next scheduled teleconference. That Center will present and lead the scientific discussion of the application at the next teleconference. The ICSC must notify the Donating Investigator of acceptance or denial. If accepted, the ICSC is expected to request a signed Material Transfer Agreement and the protocols required to verify the genotype of each submitted strain from the Donating Investigator.

7)     Establish and maintain a password-protected, central electronic archive of MMRRC documents, and other files. The ICSC is required to provide access via the Internet to MMRRC Centers, NCRR Program staff, and other individuals authorized by the Program Official.

8)     The ICSC will follow the policy guidelines developed by the MMRRC Coordinating Committee (CC) and by the MMRRC Steering Committee (SC). Upon request, the ICSC will report to the CC or the SC on the details of policy implementation, and will aid these groups in their decision making.

9)     Participate in the monthly teleconference of the MMRRC. The ICSC is expected to  solicit input from the Centers and the Program Official for agenda items, e-mail a draft agenda to the Program Official for approval five (5) days prior to the teleconference, revise and e-mail the approved agenda to teleconference participants one day prior to the teleconference, record the minutes of teleconference, submit minutes to Program Official for approval one week after each teleconference, and revise and e-mail the approved minutes to Centers five days prior to next teleconference.

10)  Participate in and contribute to the MMRRC Committees, Subcommittees, and the MMRRC Annual Meeting. The Principal Investigator of the ICSC is expected to serve as a regular member of the Informatics Subcommittee and Public Relations Subcommittee, and serve as a nonvoting member of the Coordinating Committee. The Principal Investigator and other key personnel are required to attend the Annual Meeting of the MMRRC.

11)  Develop summary statistics of the progress of the MMRRC project. The ICSC is required to compile and update monthly summaries of the numbers of mouse strain submissions (total and accepted); status of strain acquisitions; strain importation progress (by Center and overall); number of customer service contacts (total and type of inquiry); distributions of frozen embryos, spermatozoa, ES cell lines, and living mice (by Center, germplasm category, and overall); and a list of institutions that have sent or received strains from the MMRRC and the number of strains in each category.

Timelines and Milestones:  The applicant for the new MMRRC Informatics, Coordination and Service 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 the ICSC 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 1.2 person months 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 (e.g., Animal/Genetic Resource Associate Director or Associate Dean/senior level faculty/Program Director at a University).  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 informatics coordinating center 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 informatics, coordination and service center effort will be integrated, and how collaborations or subcontracts, if proposed, will be managed.  As the Informatics, Coordination and Service Center is to provide centralized processing and infrastructure for the individual MMRRC facilities, coordination of the activities with the MMRRC repositories, as well as with the activities of other national mouse programs must be described.

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(s).
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".

2. Funds Available

The estimated amount of funds available for support of one project awarded as a result of this announcement is between $500,000-$650,000 direct costs for fiscal year 2011. 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. 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

Number of Applications. Applicants may not submit more than one application, provided they are scientifically distinct.

Resubmissions.  Resubmission applications are not permitted in response to this FOA. 

Renewals. Renewal applications are not permitted in response to this FOA.

Section IV. Application and Submission Information


1. Address to Request Application Information

The current 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

Prepare all applications using the PHS 398 application forms and in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html).

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.

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.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the 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
Letter of Intent Receipt Date: Not Applicable
Application Receipt Date: October 7, 2010
Peer Review Date: December 2010
Council Review Date: May 2011
Earliest Anticipated Start Date: July 2011

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:

Mohan Viswanathan, Ph.D.
Office of Review
National Center for Research Resources
One Democracy Plaza, Room 1084
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) 435-435-0811
FAX: (301) 435-480-3660
Email: viswanam@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 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/archive/grants/policy/nihgps_2003/index.htm.)

6. Other Submission Requirements

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

PHS398 Research Plan Sections

All application instructions outlined in the SF424 (R&R) Application  Instructions are to be followed, with the following additional requirements:

Budget

This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

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. Applications that do not adhere to the policy on what is allowed in the appendix will not be reviewed. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

Do not use the Appendix to circumvent the page limitations. 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 should 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/.

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

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Review 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 mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability.  As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system. 

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed). 

Scored Review Criteria

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each.  An application does not need to be strong in all categories to be judged likely to have major scientific impact.  For example, a project that by its nature is not innovative may be essential to advance a field.

Significance. Does the project address an important problem or a critical barrier to progress in the field?  If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?  How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  Will the proposed center be able to effectively interact with the MMRRC repositories and track the progress of their activities?

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project?  If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training?  If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?  If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?  Have the Principal Investigator and other key personnel demonstrated a record of directing informatics activities related to an Informatics, Coordination and Service Center?

Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?  Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?  Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?   If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?  To assure continuous operations of the MMRRC, are there appropriate plans to acquire and transfer all data, information, and electronic files from the current holder of the mutant mouse informatics coordinating center? Are there well-reasoned and appropriate plans to establish and manage a customer service center and public relations activities, including the performance of customer service satisfaction surveys and the development of action plans to improve operations? How feasible are the plans to integrate or link to data from other mouse resource efforts in the U.S.? Do plans for the Informatics, Coordination and Service Center include reasonable milestones, timelines, and goals?

Environment. Will the scientific environment in which the work will be done contribute to the probability of success?  Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?  Will the project benefit from unique features of the scientific environment, subproject populations, or collaborative arrangements?  Are the database and informatics systems state of the art? Are there suitable plans to store and disseminate the relevant MMRRC data?

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects.  For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects  and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children.  When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals.  The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

Biohazards.  Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmission Applications.   Resubmissions are not allowed for this FOA.

Renewal Applications Renewals are not allowed for this FOA.

Revision Applications.  Revisions are not allowed for this FOA.

Additional Review Considerations

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations.   Foreign applications are not allowed for this FOA.

Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans.  Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:  1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

Budget and Period Support.  Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Selection Process

The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

Not Applicable

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 No A will be generated via email notification from the awarding component to the grantee 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 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 Investigator will have the primary responsibility 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 Investigator(s). The PI(s) will be responsible for defining the details for providing essential informatics and coordinating services to the centers of the MMRRC and biomedical researchers by providing the following.

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 will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.  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 MMRRC Consortium; and as a voting member of the MMRRC Consortium, attends major meetings of the subcommittees, and should be informed on all major interactions.

Additionally, an agency program official or IC program director 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 ICSC awardee will be members on the MMRRC Consortium, which serves as the governing board for the group of awards, as defined below. The MMRRC Consortium members are responsible for reviewing the plans for development and operation of the MMRRCs as proposed in the individual applications of awardees. The MMRRC Consortium 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 MMRRC Consortium 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 MMRRC Consortium is also responsible for selecting members of the External Steering Committee (SC) to the Mutant Mouse Regional Resource Centers (see below).

The MMRRC Consortium 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 MMRRC Consortium. The structure of the MMRRC Consortium should be established at the first meeting as noted below. The Chair of the MMRRC Consortium will be responsible for coordinating MMRRC Consortium activities. The NCRR Project Scientist will be responsible for approving the agenda and minutes.  Subcommittees will be established by the MMRRC Consortium, as it deems appropriate.

The NCRR Project Scientist will serve on subcommittees as he/she deems appropriate. At its initial meeting, the MMRRC Consortium will elect a chairperson, who must not be the NCRR Program Official or NCRR Project Scientist. The MMRRC Consortium will determine whether additional MMRRC Consortium 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 MMRRC Consortium.

The MMRRC Consortium 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 MMRRC Consortium.

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 MMRRC Consortium 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. Dispute Resolution 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 Dispute Resolution. A Dispute Resolution 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 dispute resolution procedure does not alter 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:

Michael C. Chang, Ph.D.
Division of Comparative Medicine
National Center for Research Resources
6701 Democracy Boulevard
Bethesda, MD  20892-4874
Telephone:  (301) 435-0744
FAX:  (301) 480-3819
Email: changmic@mail.nih.gov

2. Peer Review Contacts:

Mohan Viswanathan, Ph.D.
Office of Review
National Center for Research Resources
6701 Democracy Boulevard
Bethesda, MD  20892-4874
Telephone:  (301) 301-435-0811
FAX:  (301) 301-480-3660
Email: viswanam@mail.nih.gov

3. Financial or Grants Management Contacts:

Leslie Le
Grants Management Specialist
National Center for Research Resources
6701 Democracy Boulevard, Room 1043
Bethesda, MD  20892-4874
Telephone:  (301) 435-0844
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.

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-09-116.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.

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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