Part I Overview Information


Department of Health and Human Services

Issuing Organization
National Center for Research Resources (NCRR), (http://www.ncrr.nih.gov)

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

Components of Participating Organizations
National Center for Research Resources (NCRR), (http://www.ncrr.nih.gov)
National Human Genome Research Institute (NHGRI), (http://www.genome.gov
National Institute of Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov)
National Institute of Allergy and Infectious Disease (NIAID), (http://www.niaid.nih.gov)
National Institute on Aging (NIA), (http://www.nia.nih.gov)
National Heart, Lung and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/)
National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov)
National Institute of Dental and Craniofacial Research (NIDCR), (http://www.nidcr.nih.gov)
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov)
National Institute of Environmental Health Sciences (NIEHS), (http://www.niehs.nih.gov)
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov)

National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov)

Title: Knockout Mouse Project (KOMP) Repository (U42)

Announcement Type
New

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

Request For Applications (RFA) Number: RFA-RR-06-005

Catalog of Federal Domestic Assistance Number(s)
93.389  

Key Dates
Release Date: September 20, 2006
Letters of Intent Receipt Date(s): October 30, 2006
Application Receipt Date(s): November 30, 2006   
Peer Review Date(s): January/February 2007
Council Review Date(s): May 2007
Earliest Anticipated Start Date: July 2007
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: December 1, 2006

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
  1. Research Objectives

Section II. Award Information
  1. Mechanism(s) of Support
  2. Funds Available

Section III. Eligibility Information
  1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
  2.Cost Sharing or Matching
  3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
  1. Address to Request Application Information
  2. Content and Form of Application Submission
  3. Submission Dates and Times
    A. Receipt and Review and Anticipated Start Dates
      1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
  4. Intergovernmental Review
  5. Funding Restrictions
  6. Other Submission Requirements

Section V. Application Review Information
  1. Criteria
  2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
  3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
  1. Award Notices
  2. Administrative and National Policy Requirements
    A. Cooperative Agreement Terms and Conditions of Award
      1. Principal Investigator Rights and Responsibilities
      2. NIH Responsibilities
      3. Collaborative Responsibilities
      4. Arbitration Process
      5.  Panel of Scientific Consultants
      6. KOMP Working Group
      7. Yearly Milestones
  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

This FOA is being issued as part of the NIH Knockout Mouse Project (KOMP) which has as its goal the generation of a comprehensive resource of mutant alleles that will be a powerful and important tool in the study of human disease.  For many years, mouse mutations that cause phenotypes that mimic human traits or diseases have served as critical research tools in understanding the genetics underlying mammalian biology.  The importance of the mouse as a model organism was indicated by the inclusion of a plan to construct genetic and physical maps of the mouse genome and to produce a high quality, finished sequence of the mouse genome (strain C57BL/6J) in the goals of the Human Genome Project. 

To complement the mouse genome sequence and the full-length cDNA collection currently under construction, a defined genetic resource that can be used to elucidate gene function is needed.  To this end, the attendees at an international meeting convened in the Fall of 2003 strongly supported the establishment of a focused, large-scale international effort to produce a publicly available, comprehensive collection of mouse knockout alleles, i.e., a library containing a null mutation in every gene in the mouse genome (Austin, C.P, et al. Nature 36, 921-924, 2004).  The meeting attendees also recommended a phased production approach, beginning with the construction of a resource of ES cells comprising a comprehensive collection of null alleles, followed by the construction of mice from the ES cells, and then pheno-typing the mice with an increasingly sophisticated set of tests. 

There has subsequently been a significant set of international efforts to further define and deliver these mutant mouse resources to the scientific research community.  Several international groups have planned, or have been funded for, efforts to create conditional mouse knockouts (e.g., the European Conditional Mouse Mutagenesis Program (EUCOMM) and a complementary project in Canada).  To date, mouse gene mutations, primarily nulls, have been constructed in at least 10,000 unique mouse genes by either gene-trap or targeted knockout methods.  Many of these are still unavailable to the scientific public, and cannot be considered as part of the proposed effort until they are deposited in public repositories.

A 2005 NIH workshop (http://www.genome.gov/15014549 ) endorsed the following points:  (1)  researchers would prefer a resource based on the C57BL/6 strain, if technology were available to do that, (2) given that 10,000 of the approximately 20-25,000 genes in the mouse genome have been knocked out, isolation of mutations in a minimum of 10,000 remaining mouse genes is needed to complete the current resource, and (3) given that of the estimated 10,000 genes that have already been knocked out, only 3 to 4,000 are represented by existing knockout mice residing only in research laboratories around the world, an effort to collect and preserve as many as possible of these existing mutants as embryos is a high priority.

The NIH established the KOMP program to encompass these recommendations.  KOMP consists of four components, one of which is being solicited by this FOA.  The three other components of the KOMP have previously been funded (http://www.genome.gov/19517927); awardees from all four components of KOMP will work together as the KOMP Research Network.  (http://grants2.nih.gov/grants/guide/rfa-files/RFA-HG-05-007.html; http://grants2.nih.gov/grants/guide/rfa-files/RFA-HG-05-008.html; http://grants2.nih.gov/grants/guide/rfa-files/RFA-DA-06-009.html).  

The three funded components the KOMP will support the following research:  1) large-scale gene targeting efforts to generate up to 10,000 null mutants that, in combination with the results of other directed mutagenesis efforts, will provide a complete knockout mouse resource to the research community; 2) technology development efforts to generate C57BL/6 ES cell lines that are efficient in germ line transmission; and 3) a Data Coordination Center that will provide a public interface for all of the data generated by the KOMP Research Network. 

The purpose of this FOA is to solicit applications to develop a repository that will play an integral role in the KOMP Research Network by serving to collect and distribute resources generated through the KOMP initiative.  Specifically, the goals of the repository will be to: 1) establish archives of resources generated by the other components of the KOMP Research Network, namely, ES cells, frozen embryos, DNA constructs, and live mice; and 2) distribute mutants as cryo-preserved ES cells, frozen embryos, or live mice.  The successful repository will use state-of-the-art methods to establish banks of cryo-preserved ES cells, embryos, and DNA constructs, distribute cryo-preserved materials to qualified investigators, and distribute live mice that have been reanimated from cryo-preserved material.  The successful repository should be flexible enough to adjust in response to any changed needs of the KOMP.  For example, if, in the future, technology is developed to successfully cryo-preserve C57BL/6 sperm, the repository may be asked to adjust its archiving plans. 

The successful repository, in addition to providing the services listed above, must also be cost-effective. Thus, applicants must demonstrate prior experience and expertise in four required elements to be responsive: 1) the ability to acquire, bank, and distribute cryo-preserved ES cells and embryos,  2) the ability to acquire live mice from the KOMP Research Network, create banks of cryo-preserved mouse embryos from them, and then distribute these cryo-preserved materials, 3) the ability to reanimate live mice from frozen ES cells and embryos, and to distribute live mice, and 4) the ability to replenish ES cells and convert frozen banks of ES cells, or embryos, by reanimation of mice and cryo-preservation of embryos. Applications will be accepted only from institutions that can demonstrate that they have prior experience in collecting, archiving, and distributing mutant mice or ES cells, with a combined inventory of at least 100 mouse lines as frozen ES cells or embryos. Specifically, competitive applications must document and demonstrate a past and current track-record of archiving mouse strains and ES cells, operating a user-friendly database, managing an efficient, high quality customer service operation, and distributing high-quality ES cells, embryos, and live mice. The application should also describe past activities and future plans related to community outreach, training, and advertising the resource.  Finally, competitive applications must discuss the general approach and strategies to be used to achieve the proposed repository and distribution goals of the KOMP Research Network, keeping in mind that the goal of the KOMP repository is to develop, over time, into a self-supporting operation.

If an institution with substantial repository expertise and infrastructure lacks one or more of the required skills or capabilities listed, collaboration with a partner institution may provide the necessary expertise for a successful and fully responsive proposal to this FOA. A single institution may not submit more than one application nor, can it submit an application and also act as a subcontractor in another institution’s application.

Foreign institutions and foreign components of applications are not eligible to apply for NIH-supported resources.  Applications from ineligible institutions will be returned without review, and if reviewed, will be precluded from receiving an award. 

In summary, the purpose of this FOA is to solicit applications that propose to build upon demonstrated expertise and experience to expand existing repository capacity to both archive and distribute the ES cells, embryos, sperm DNA constructs, and live mice that will be generated by the KOMP Research Network; to ensure safe storage conditions; to provide user-friendly access to the database inventory; to operate a customer service center, and in the long term, become self sufficient. 

Scope of resources to be generated by the KOMP Research Network:  The funded KOMP Research Network proposes to generate the following resources that the successful KOMP repository will collect and distribute: 

DNA constructs:    8,000-13,500

Mutant ES cell lines with 2-5 mutant ES cell samples per line:  8,000-8,500

Live mice from mutant ES cell lines:  up to 500 mutant mice

C57BL/6 ES cell lines: up to five ES cell lines

The estimated year-by-year schedule for acquiring resources from the production centers for distribution:

   Year 1    Year 2   Year 3 Year 4 Grand Total
DNA Constructs:   2,910   3,235  3,677   3,678   8,000-13,500
Mutant ES cell lines: 1,660     1,985  2,427 2,428   8,000-8,500
Live mice from          
mutant ES cell lines:       100  150  125  125 500

Because the production components of the KOMP Research Network were funded before the KOMP repository will be, the initial distribution of any KOMP resources before the Repository is established will be done individually by the KOMP grantees.  The KOMP repository will, however, need to import any resources made during this interim period from the KOMP grantees.  Applicants for the KOMP repository under the current FOA must include a plan for incorporating these KOMP products into the repository. 

The following paragraphs describe, in more detail, the information required in a competitive KOMP repository application.

Repository functions:  The applicant must document a successful track record of running an established mouse repository or equivalent.  This must include a description of the animal facility as well as the methods used for cryo-preservation, health status assessment, and genetic quality control.  The applicant must further document past experience with the following activities: 1) acquisition and cryo-preservation of ES cells, embryos, and live mice  (the number of total samples in the collection and the number acquired during the 12 months prior to submission of the application should be numerated), 2) distribution of mouse lines as live mice and cryo-preserved material to requesting scientists (the total numbers of samples distributed since inception, and the number distributed during the 12 months prior to the submission of the application should be numerated), 3) provision and maintenance of a repository website with an online catalog of strains and reagents, 4) operation of a tracking database for the repository, including records of mouse lines and related biomaterial, as well as electronic connectivity and interaction with local, regional, and national networks (e.g., FIMRe - www.fimre.org), 5) operation of a customer service center, and 6) administrative controls relevant to the activities of the repository.  This track record needs to be well established and described in sufficient detail for the application to be considered responsive. 

The applicant must propose detailed plans describing the design and development of a mutant mouse repository for the KOMP Research Network. First, the applicant must propose detailed plans and procedures for the acquisition and storage of all resources that will be produced by the KOMP Research Network.  See “Scope of resources to be generated by the KOMP Research Network” listed above.  Second the applicant must describe the design of all required bioinformatics needs, including software and electronic network links between the KOMP repository and the KOMP Data Coordination Center. The design and development of the database should be such that it provides a user-friendly accounting of the repository’s holdings, including all cryo-preserved materials and live mouse lines.  Third, the applicant must describe how requests for ES cells, embryos, DNA constructs, or mice generated by the KOMP Research Network will be handled, including how mice will be generated from ES cells or embryos.  Fourth, in anticipation that not all requestors can handle cryo-preserved material, the applicant must describe the fee-for-service charges that will cover the expense of generating mice from ES cell lines or embryos. Fifth, as a significant fraction of the resource is likely to be ES cells, and many will be made into mice outside of the repository, the applicant should propose a plan of how to maximize the return of these mutant mice or embryos to the repository for preservation and distribution.  Sixth, a strategy and rationale for keeping “high demand” lines as live colonies should be described.  The application should describe a plan for making live mice from at least 250 archived ES cell lines over four years in response to requests from the scientific community.  Seventh, the strategy and rationale for replenishing cryo-preserved material, or converting stocks from, for example, ES cells to embryos, should be described. Eighth, the applicant must outline a plan for a phased increase for the cryo-preservation of embryos from live mutant mice from the KOMP Research Network collaborators.  The plan should anticipate receiving 100, 150, 125, and 125 mouse lines in, respectively, years 1, 2, 3, and 4 of the funding period; the application plan needs to describe how these mouse lines will be acquired, stored and made available for distribution to scientists.  The applicant should describe an expense recovery plan for these activities, such that costs are fairly distributed among all users of the repository. Finally, the applicant must outline an overall cost-recovery program that will, at the end of four years of NIH funding, establish a self-sufficient KOMP repository.

Background on customer service and public relations – The applicant must describe plans for a user-friendly customer service interface.  This plan needs to provide access for scientists who search for specific mouse lines for non-commercial research, who have technical questions regarding the search, identification, or specification of a mouse line, or who need assistance with decisions on ordering cryo-preserved materials (ES cells or embryos) or obtaining live mice through the repository’s reanimation service.  Moreover, the applicant must also outline plans for the development of advertisement and enhancement of public relations of the KOMP repository. 

Background on storage – The applicant must describe plans for state-of-the-art cryo-preservation of all imported mutant ES cell lines, embryos and mouse lines, which will yield the highest quality and most secure archive.  Specifically, storage facilities, current technologies and plans for future developments, existing expertise for the reconstitution of cryo-preserved embryos, among other issues, need to be described.  Current and future capacities of the repository must be described. 

Background on quality control – The applicant must describe protocols for state-of-the-art quality control measures. Examples of appropriate quality control procedures include evaluation of the accuracy of material tracking, testing of pathogen status, validation of the mutant allele and strain background of mouse strains by genotyping, and monitoring success in embryo or sperm cryo-preservation and subsequent reanimation. Evidence of past experience with and effectiveness of the proposed quality control programs should be included. The applicant should describe the steps that will be taken to ensure that the activities of the repository are in compliance with the standards for international repositories.

Milestones:  The application should present specific milestones that will need to be met in order to accomplish the work set out above in a four-year time frame.  Actual milestones for the funded effort will be negotiated before an award is made.  

Management Plan: The effective management of a repository project requires a significant commitment by the Principal Investigator (P.I.).  The P.I. of a large-scale resource project funded under this FOA is expected to devote at least 10% effort to the project.  The applicant should have direct experience, knowledge, and hands-on involvement in daily operations.  It is expected that this individual will be an established scientist with a fitting level of seniority within the applicant institution, and with appropriate authority.  The applicant should describe the management plan for the proposed project, and how it will support achievement of the proposed goals and milestones.  The application should describe the organization of the proposed repository effort and its management structure, including integration of the separate components to form an efficient pipeline, key personnel, section leaders, and reporting relationships.  Recruitment and training of personnel should be discussed.  The plan should also describe how the various components of the proposed repository effort will be integrated, and how collaborations or subcontracts, if proposed, will be managed.  Coordination of the awardee’s activities with those of the other components of the KOMP, as well as with other national and international programs aimed at producing and archiving mouse knockouts, must be described. 

Bioinformatics and Database information:  The applicant must provide a detailed plan describing the bioinformatics tools required for the KOMP repository.  These include, but are not limited to, the informatics infrastructure of the production system, such as the basic Information Technology infrastructure/system administration, the laboratory information management system, and the system for data handling and deposition, plus any informatics that will be used to provide a public interface for describing the nature and status of all repository materials.  In all cases, any needed software development should be described in detail, including how it will be made publicly accessible.  Additionally, a plan as to how the repository data will be provided to the KOMP Data Coordination Center is needed.  Finally, a description of bioinformatics tools for customer service operations, and linkage to local electronic networks to regional and national networks (e.g., FIMRe - www.fimre.org) will be needed.  

Intellectual Property 

“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). 

Data and resource release/Sharing policy:  NIH strongly endorses rapid release of genomic data and materials as a general practice.  NIH has also identified the goal of the KOMP Research Network as the production of a “community resource” as described in the proceedings of the Meeting on Sharing Data from Large-Scale Biological Research Projects (http://www.wellcome.ac.uk/doc_wtd003208.html).  Applicants should also be familiar with the NIH statements regarding sharing of resources developed with Federal funds (http://www.ott.nih.gov/policy/rt_guide_final.html).  Responses to this FOA should propose specific and comprehensive plans for data and resource release for non-commercial research, as the quality of this plan will be an important criterion in the review of the application.  Appropriate data and resource release plans will be made a condition of the awards made as a result of this FOA.  The release of data to the project’s public tracking website at the Data Coordination Center must be discussed and include all elements outlined above.

Costs:  The applicant must provide a plan for a charge-back fee for reanimation, distribution and restocking that will result in self-sufficiency of the repository no later than the end of the 4-year funding period.  All proposed costs and projected cost reductions asked for above must be given in terms of the 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.

Budget 

The applicant must present a fully justified budget for the work described above.

Non-U.S. applicants 

Under this FOA, NIH will not award grants to non-U.S. applicants nor will awards be made to applicants that have a non-U.S. component. 

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the U42 cooperative agreement award mechanism(s).

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

The NIH U42 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award". Plans for continuation of this program beyond this current funding opportunity are not definite.

2. Funds Available

The participating IC(s) NHGRI, NCRR, NHLBI, NIA, NIAAA, NIAID, NICHD, NIDA, NIEHS, NIDCR, NINDS and NIMH intend to commit approximately 4.8M dollars over FY 2007-2010 to fund 1 new cooperative agreement in response to this FOA. An applicant may request a project period of up to 4 years and a budget for direct costs up to 4.8M dollars over 4 years.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

Foreign institutions and foreign components of applications are not eligible to apply for NIH-supported resources.

1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.  

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

As described in the Research Objectives section (above), applicants must be able to provide existing infrastructure and demonstrate a track record for management of a mouse repository, the distribution of mice, cryo-preserved germplasm and reagents in order to apply.

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 on line 2 of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Letters of Intent Receipt Date(s): October 30, 2006
Application Receipt Date(s): November 30, 2006
Peer Review Date(s): January/February 2007
Council Review Date(s): May 2007
Earliest Anticipated Start Date(s): July 2007

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Franziska Grieder, DVM, PhD
Division of Comparative Medicine
National Center for Research Resources
6701 Democracy Blvd, Room 948
Bethesda, MD  20892-4874
Telephone:  (301) 435-0744
FAX:  (301) 480-3819
Email:  Griederf@ncrr.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Ken Nakamura, Ph.D.
Office of Scientific Review
National Human Genome Research Institute
5635 Fisher Lane
Suite 4076
Bethesda, MD 20892
Telephone: (301) 496-7531
FAX: (301) 480-2770
Email: nakamurk@mail.nih.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NHGRI. Incomplete and non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

6. Other Submission Requirements

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

See Section V. 2.C. Sharing Research Data

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

See Section V. 2.D. Sharing Research Resources

Section V. Application Review Information


1. Criteria

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

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NHGRI in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

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

Will the proposed plan and reasonableness of the timelines for the KOMP repository provide for the attainment of the following goals:

Do the track records of the Principal Investigator and other Key Personnel provide indicate a high level of experience and expertise in applying state-of-the-art methods for the acquisition, cryo-preservation, and distribution of mouse strains?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

All applications must include a plan for sharing research data. The standard NIH data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible. However, rapid release of the data would be of benefit to the scientific user community because of the scope of this community resource project as described in this FOA and because of the national and scientific investment that the NIH will make in the KOMP program. Accordingly, applicants should not feel constrained by the standard approach to data sharing but should display and promote innovative methods for achieving the maximum use of the KOMP Research Network resources.

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy. The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. Section I. “Research Objectives” contains a section entitled “Data and Materials Release” that addresses the issues that can be used in a data sharing plan for a KOMP component.
 
2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.  However, as indicated in the previous section with respect to the data sharing plan, applicants should not feel constrained to propose a standard plan for sharing materials, given the scope of the KOMP Research Network as defined by the FOA and the NIH's investment in this project. Widespread dissemination and access to the materials generated through this program to the public and private research sectors are an aim of this FOA and will require innovative methods for achieving the maximum use of the resource to be produced under this project.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates
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 (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

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.

The KOMP Research Network will involve four distinct activities -- generation of the knockout mouse resource, a data coordination center, further development of the C57BL/6 ES cell system, and a KOMP Repository. The first three activities listed have been funded http://www.genome.gov/19517927 and the fourth (KOMP Repository) is funded through RFA RR-06-005.  All components of the KOMP Research Network will be funded by cooperative agreements, and a single Steering Committee (section 2.A.3) and a single Panel of Scientific Consultants (section 2.A.4) will serve for all of the KOMP activities. The Terms and Conditions described below are specific for this FOA (RR-06-005), but have been coordinated and made consistent with those described in the other FOAs that solicited components of the KOMP Research network.

2.A.1. Principal Investigator Rights and Responsibilities
The Principal Investigator will have the primary responsibility for: defining the details for collection, archiving and dissemination of the KOMP resources for the KOMP Repository, as well as the other activities outlined within the guidelines of RFA RR-06-005, and for performing the scientific activities.  The P.I. will agree to collaborate with the other members of the KOMP Research Network and to accept close coordination, cooperation, and participation of NIH staff and advisors in those aspects of scientific and technical management of the project as described under 2.A.2. NIH Responsibilities.

The awardee will have primary and lead responsibility for the project as a whole, including mouse husbandry, gamete and embryo cryo-preservation and revitalization, microbiological and genetic monitoring, data quality control and reporting to the Panel of Scientific Consultants (PSC), research to enhance the resource, preparation of publications, and collaborating with the other awardees, with assistance from the NCRR Project Scientist.

The P.I. will:

Attend a yearly meeting with the Panel of Scientific Consultants. 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.

For the KOMP Research Network, a Project Scientist will be appointed from each of the Institutes that is responsible for the participating cooperative agreements, that is, NHGRI (for the awards for the large-scale mutant mouse production and the Data Coordination Center), NIDA (for the awards for ES cell development and production) and NCRR (for the KOMP Repository ).

For the KOMP Repository award,  the NCRR Project Scientist will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice and coordination. However, the role of the NCRR Project Scientist will be to facilitate and not to direct the activities. It is anticipated that decisions in all collaborative activities will be reached by consensus of the KOMP Steering Committee, of which the PI is a member, and that the NCRR Project Scientist will participate in this process. The NCRR Project Scientist shall participate as a member of the Steering Committee and will have one vote.

The Project Scientist will:

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 Steering Committee will serve as the main governing board of the KOMP Research Network. The Steering Committee membership will include the P.I. of each awarded cooperative agreement and the NIH Project Scientist of each of the four components of the KOMP Research Network. Additional members may be added by action of the Steering Committee. Members of the NIH KOMP Working Group may attend the Steering Committee meetings. Government employees outside of NIH KOMP Working Group members may also attend, if their expertise is required for specific discussions.

The Steering Committee will:

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 NCRR may be brought to arbitration. An Arbitration Panel composed of three members will be convened: a designee of the Steering Committee chosen without NCRR staff voting, one NHGRI 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.  The Arbitration Panel will help resolve both scientific and programmatic issues that develop during the course of work and that restrict progress. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

2.A.5. Panel of Scientific Consultants

The Panel of Scientific Consultants (PSC) will be responsible for reviewing and evaluating the progress of the members of the KOMP Research Network toward meeting their individual and collective goals. The PSC will provide recommendations to the NIH KOMP Working Group, the Directors of NCRR, NHGRI and NIDA, as well as the Directors of the all other participating institutes, about continued support of the components of the KOMP Research Network. The Panel will be composed of four to six senior scientists with relevant expertise who are not P.I.s of a cooperative agreement involved in the KOMP Research Network. The Panel of Scientific Consultants will be appointed by the Directors of NCRR, NHGRI and NIDA, with concurrence from the Directors of all other participating Institutes. The membership of the Panel of Scientific Consultants may be enlarged permanently, or on an ad hoc basis, as needed.

The Panel of Scientific Consultants will meet at least once a year in person and by conference call 2 to 3 times per year. During part of the yearly meeting, there will be a joint meeting with the Steering Committee to allow the PSC members to interact directly with the awardees. Annually, the PSC will make recommendations to the NIH regarding progress of the KOMP Research Network and present advice about changes, if any, which may be necessary in the KOMP Research Network program to the Directors of NCRR, NHGRI and NIDA and the Directors of the other participating institutes.

Awards funded under this FOA will have a second, repository-specific advisory panel (AP) that will be a subcommittee of the PSC.  It will oversee the repository of the NIH-funded KOMP Research Network.  This AP will be composed of three animal or biological materials resource scientists and at least one database or informatics expert.  The NIH Project Scientists responsible for the KOMP Repository and the Data Coordination Center will participate in the AP.  The advisory panel will meet by teleconference twice a year or as frequently as needed; the panel will meet at least once per year with the overall KOMP advisory group and with the Principal Investigator(s) funded under this KOMP FOA.  The purpose of the AP is to discuss accomplishments, encountered road blocks and how they are being resolved, as well as future directions and report back to the Panel of Scientific Consultants.

2.A.6. NIH KOMP Working Group

The NIH KOMP Working Group consists of program staff from the each of the NIH institutes supporting the KOMP initiative. The purpose of the NIH KOMP Working Group will be to disseminate information about the progress of the KOMP Research Network to the participating institutes and to provide a forum for the participating institutes to discuss issues related to KOMP. The  NIH KOMP Working Group members will report to the Director of their respective IC. The NIH KOMP Working Group will be chaired by the NHGRI Project Scientist for the knockout mouse resource component of the KOMP.

2.A.7. Yearly Milestones

The awardee will be asked to define a set of yearly milestones at the time of the award and to update these milestones annually at the anniversary date. These will be made a condition of the award. In accord with the procedures described above, NCRR may withhold or reduce funds for a project that substantially fails to meet its milestones or to maintain the state of the art in the field.

3. Reporting

The awardee will be required to submit periodic semi-annual progress reports in a standard format, as agreed upon by the Steering Committee and the Scientific Advisory Panel.
 
Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

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:

Franziska Grieder, DVM, PhD
Comparative Medicine
National Center for Research Resources
6701 Democracy Blvd, Room 948
Bethesda, MD  20892-4874
Telephone:  (301) 435-0744
FAX:  (301) 480-3819
Email:  Griederf@ncrr.nih.gov

2. Peer Review Contacts:
 
Ken Nakamura, Ph.D.
Office of Scientific Review
National Human Genome Research Institute
5635 Fisher Lane
Suite 4076
Bethesda, MD 20892
Telephone: (301) 496-7531
FAX: (301) 435-1580
Email: nakamurk@mail.nih.gov

3. Financial or Grants Management Contacts:

Ms. Irene Grissom
Office of Grants Management
Comparative Medicine
National Center for Research Resources
6701 Democracy Blvd, Room 1036
Bethesda, MD  20892-4874
Telephone:  (301) 435-0844
FAX:  (301) 480-3777
Email:  Grissomi@ncrr.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.

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/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.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_manual.htm).

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 PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:

This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.