Part I Overview Information


Department of Health and Human Services

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

Components of Participating Organizations
National Institute of General Medical Sciences (NIGMS) (http://www.nigms.nih)

Title: Modeling of Infectious Disease Agent Study Centers of Excellence (U54)

Announcement Type
New

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

Request For Applications (RFA) Number: RFA-GM-09-003

Catalog of Federal Domestic Assistance Number(s)
93.859

Key Dates
Release Date: July 15, 2008
Letters of Intent Receipt Date: September 24, 2008
Application Receipt Date: October 24, 2008
Peer Review Date(s): February – March 2009
Council Review Date: May 2009
Earliest Anticipated Start Date: July 1, 2009 
Expiration Date: October 25, 2008

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
     A. Cooperative Agreement Terms and Conditions of Award
         1. Principal Investigator Rights and Responsibilities
         2. NIH Responsibilities
         3. Collaborative Responsibilities
         4. Arbitration Process
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Background

The threat of emergence or re-emergence of infectious disease epidemics continues to be a concern of policymakers and the public health services.  Better resources, knowledge, and tools are needed to improve our knowledge of the dynamics of emergence, surveillance and detection of events, and the effectiveness and implications of prevention and mitigation efforts.  The variety of possible scenarios complicates the challenge of confronting these threats. An important role of science is to create a rational picture of the alternatives by collecting, analyzing, and interpreting relevant data and by developing models. The models themselves can guide the collection of further data. In addition, good models can reveal important patterns in the data, allow investigators to examine scenarios, and facilitate understanding of likely consequences of interventions.  These capabilities can help responsible parties plan for and respond to an emerging epidemic or a bioterrorist threat.

The existing MIDAS network began in May 2004 with the funding of three research groups and one informatics group.  Subsequently, four additional research groups were funded.  As a result of a formal formative evaluation and a white paper developed by the infectious disease modeling community, NIGMS initiated a change in the structure of MIDAS, which this FOA reflects.  The new MIDAS Network will be composed of research groups, an information technology resource, and Centers of Excellence as described in this announcement.  The Network will continue to be a multidisciplinary, multicomponent effort, comprising an important component of an overall public health strategy for managing emerging infectious diseases.

Information on current and previous MIDAS activities, publications, and reports can be found on the MIDAS website at https://www.epimodels.org or http://www.nigms.nih.gov/Initiatives/MIDAS/.

The Centers funded as a result of this FOA will be fully integrated into the MIDAS Network. The MIDAS Network will focus on developing scientific knowledge of computational and mathematical models of infectious diseases and providing that knowledge to the scientific, public health, and policy communities. Successful Center applications will address four major thematic areas – infectious disease research; computational, statistical, and mathematical research; education and outreach; and public health policy.  Centers will build outstanding research programs in infectious disease modeling by providing opportunities for multidisciplinary conversation and collaboration, by providing national and international leadership, and by training the leaders of tomorrow.  Over a period of time, Centers should evolve into foci of highly integrated and trans-disciplinary research, training, and knowledge related to modeling of infectious diseases.

Thematic Areas

Areas of research could include, but are not limited to, the following:

Infectious Disease Research

Surveillance and Detection. A critical step in responding to an event is correctly identifying and characterizing it.  In some cases, the speed and accuracy of a response (e.g., antimicrobials, vaccines, isolation, or community containment measures) may determine whether an outbreak will be contained or a crisis averted.  Technological advances in disease detection, including bioinformatics and syndromic surveillance, will continue to provide considerable data, and statistical and modeling methods are needed to search for and characterize signals in the presence of highly variable background information.  In addition, models may contribute to recognizing, identifying, and responding to intentionally released and/or engineered pathogens. These issues are relevant at many levels of organization from individual hospitals to communities, metropolitan areas, and countries.

Dynamics of Infectious Diseases. Infectious diseases are dynamic across temporal, spatial, and biological dimensions.  Many pathogens operate in short time scales and small geographic areas, allowing for modeling studies of ecological and evolutionary dynamics.  Infectious disease systems provide an opportunity for modeling host / parasite coevolution, microbial population structure, and natural history relevant to the spread of infectious diseases.  Epidemiological modeling has provided, and will continue to provide insights into how infectious diseases spread geospatially, temporally, and through social networks.  Combined with structural biology, phylogenetic modeling can shed light on how new disease variants emerge and spread.

Response Strategies. A critical component of MIDAS is using modeling approaches to study the implications of various response strategies.  For example, MIDAS has studied the spatial and temporal deployment of antivirals and vaccines in response to an influenza outbreak and contributed to assessing the impact of community containment on the spread of pandemic influenza in the U.S.  In addition to national response strategies, local, community, regional, and global strategies should be considered.

Antimicrobial Resistance. Antimicrobial resistance is of great concern, and modeling may contribute to understanding the evolution, sources, and spread of resistance in microbial populations.  The subject is relevant at many levels of organization (e.g., individuals, hospitals, public health systems, communities).

Behavior. Individual and social behavior contributes greatly to the dynamics of infectious disease emergence and spread and to compliance with public health policies.  Issues include, for example, implications of social organization, migrations, decision making, beliefs, norms, health practices, and trust.  Research could address, for example, the impact of behavioral changes on the course of an outbreak (and vice versa), how to measure behavior, heterogeneity in behavioral response, and representation of complex behaviors.

Domestic, Agricultural, and Wild Animals. Although the major focus of this announcement is on human disease, one cannot ignore the relevance of animals as hosts and vectors of infectious agents.  For example, bird movements via migration or illegal trafficking may facilitate the spread of avian influenza.  Population dynamics of mosquitoes are highly relevant to the spread of malaria.  Population dynamics of deer and rodents influence tick populations and the spread of Lyme disease.  Studies of animal populations should focus on issues or modeling approaches relevant to human health.

Computational, Mathematical, and Statistical Model Research

One of MIDAS’s central goals is to develop and improve mathematical, computational, and statistical methods for studying infectious diseases and to develop tools that will assist public health decision makers.  Applicants should take account of the needs of the public health and research communities in designing and producing models.  The following areas should be addressed:

Conceptual development of the model.  Underlying theories, including assumptions and approaches, strengths and weaknesses should be clearly explained. The projects should take into account the needs of the communities (i.e., public health, policy and decision making) that will be end users of the products of the research.  The projects should also address plans for ensuring the dissemination of useful products of the research, including approaches, technologies and tools, to the relevant research and user communities.  Other potential areas of research include (1) tools for archiving, managing, integrating, querying, retrieving, and visualizing model results; (2) analytical and statistical tools for interpreting and using large data sets or model results; and/or (3) platform-independent translational tools for data exchange, interoperability, and exchange of models, tools, and results.  Computational, mathematical, and statistical research proposed should be future-oriented, fill an area of need or projected need, and exceed the current state of the art.

Model verification and validation. The applicant must propose steps to verify that methods employed behave as expected, that is, that the software or equations have been reviewed, tested, and documented.  Validation is an important goal but may or may not be possible, depending on the nature of the model.  Applicants should explain how they will approach validation of software.

Dissemination. One output of MIDAS Centers should be software tools that are of value to the public health, research, and policy and decision making communities. Software tools developed with MIDAS support will be freely available to researchers, educators, the public health community, and government organizations.  Software tools should be designed and developed in collaboration with the user communities and with the MIDAS information technology resource, which is charged with hardening software tools.

Education and Outreach

The NIGMS MIDAS Centers are expected to provide national leadership in training a new generation of infectious disease modelers through a variety of approaches including, for example, support for visiting investigators, fellowships, workshops, summer courses, internships, symposia, curricula development, and/or other means.  Centers’ education and outreach programs should serve a variety of communities, including public health, policy and decision makers.

Education. Centers may conduct training at multiple levels, from undergraduate education to professional career development, as appropriate to their institutions and to the goal of developing the field of infectious disease modeling.  Applicants are expected to identify current educational needs and to propose well-reasoned and well-justified responses. 

Career Development. Applicants should propose plans to support and nurture junior and new investigators, for example, by incorporating developmental research projects led by new investigators and/or by instituting career developmental programs.  Outreach to individuals underrepresented in biomedical research is required (see Special Requirements below).

Website. Centers should serve scientific communities beyond the participating investigators and institutions, including end users of the knowledge and tools generated.  Applicants should have a plan to construct a Center website for the dissemination of research data, software, and other resources of the project.  To the extent that established public databases have the capability for collecting and disseminating the data that would be collected under the grant, it is NIGMS' strong preference that a plan for the rapid deposition of data into such public databases is included in the application.  Funded Centers and projects may, in the future, decide on a MIDAS-wide plan for acquisition, storage, management, and dissemination of data, results, and tools.

Policy Studies

MIDAS interfaces with policy and decision making when its work is used as a tool for decision making in public health.   The issues of how, when, and by whom models are used underlies MIDAS’s mission and credibility.  MIDAS Center applicants must propose programs focused on narrowing the gap between science and policy related to infectious disease modeling.  Centers are expected to provide national and international leadership on the appropriate use of modeling tools in public health.  Examples of policy research topics could include:

The role of modeling in public health decision making. MIDAS modeling results, analyses, and tools have been used to study specific policy options. Center applicants might develop projects on the scholarly study of such questions as the following:  What is the appropriate role of modeling in public health decision making? How should models be constructed to address users’ questions?  What factors facilitate useful discussion among various communities providing and using modeling results?  Under what circumstances is it appropriate to use modeling approaches?

Fostering discussion among modelers, public health communities, and decision makers. Trans-domain conversation about the role of modeling and modeling results is critical.  Center applicants may choose to sponsor workshops, conferences, and meetings to explore interfaces of modeling and policy, particularly related to public health.

Identifying and addressing public health the needs of decision makers for modeling results and tools. Center applicants should present a clear plan for collaborating with end users and addressing their needs for computational, statistical, and analytical tools.

Ethical considerations in modeling infectious disease policies and practices. Center applicants should address ethical, legal, and social implications of modeling, particularly related to policy decisions.   Work could address (1) construction of modeling assumptions and scenarios; (2) the impact of modeling on policy development and implementation; (3) ethical boundaries of detailed demographic, geographic, behavioral, or cultural data; (4) release of detailed results of modeling simulations; and (5) release of model software, results, and conclusions.

The Centers are expected to work with NIGMS staff to link MIDAS with ongoing and emerging modeling efforts such as those at the Centers for Disease Control and Prevention and at DHHS/Office of the Secretary.

Special Requirements

Recruitment and Retention Plan to Enhance Diversity

The NIH recognizes a compelling need to promote diversity in the biomedical, behavioral, clinical, and social sciences workforce. The NIH expects that efforts to diversify the scientific workforce will lead to the recruitment of the most talented researchers, improve the quality of the educational and training environment, balance and broaden the perspective in setting research priorities, improve the ability to recruit subjects from diverse backgrounds into clinical research protocols, and improve the Nation’s capacity to address and eliminate health disparities.

Accordingly, the NIH continues to encourage institutions to diversify their trainee and faculty populations and to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as individuals from underrepresented racial and ethnic groups; individuals with disabilities; and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis. The NIH is particularly interested in encouraging the recruitment and retention of the following groups of candidates:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see http://www.nsf.gov/statistics/).  Nationally, groups found to be underrepresented in biomedical and behavioral research include, but are not limited to, African Americans, Hispanic Americans, Native Americans (including Alaska Natives), and natives of the U.S. Pacific Islands.  In addition, it is recognized that under-representation can vary from setting to setting and individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program.

B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

C. Individuals from disadvantaged backgrounds who are defined as:

1. Individuals who come from families with an annual income below established low-income thresholds. These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml. For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professional Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2. Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career. Recruitment and retention plans related to a disadvantaged background are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement.

The scope and nature of MIDAS provides an excellent opportunity to enhance diversity of the biomedical research workforce.  Proposed activities must be integrated in the ongoing research and educational activities of the Center.  Applicants must describe their specific plans for and recent experience with the recruitment and selection process.  Furthermore, Center applicants must establish a position for an outreach coordinator who will be responsible for, among other tasks, leading the recruitment effort, overseeing selection and placement of trainees, assessing academic and research progress of students, etc.  Center applicants may wish to develop partnerships with minority and minority-serving institutions and organizations.  Information on relevant minority-serving institutions may be obtained by consultation with staff of the NIGMS Division of Minority Opportunities in Research (http://www.nigms.nih.gov/Minority/).  This FOA requires all applicants to submit a recruitment and retention plan to enhance diversity, which will be evaluated by reviewers and included in the determination of scientific merit and priority score of the application. 

Other NIH funding opportunities exist that can be utilized by funded projects to obtain supplemental support to promote diversity in biomedical research.  Those are described in a separate announcement (http://grants.nih.gov/grants/guide/pa-files/PA-05-015.html).

Project Director/Principal Investigator Effort

The Project Director/Principal Investigator of a Center grant must commit a minimum effort of 30% or 3.6 months per year to the project.

Organizational Structure of the MIDAS Network

The reorganized MIDAS Network will have five components: a steering committee, an executive committee, Centers of Excellence, an information technology resource, and research groups.

The steering committee is the main oversight body for MIDAS and makes recommendations to NIGMS regarding scientific direction, resources, concerns and issues, evaluation, and similar topics.  The committee includes representation from user groups such as public health officials, representatives of the research community, and NIH scientist administrators with relevant expertise. Outside expertise ensures sufficient breadth and balance on the committee. NIH scientist administrators will not comprise more than 40% of the voting members of the steering committee.

The executive committee coordinates and manages the MIDAS Network, including coordination of multi-group projects.  It is made up of the principal investigators of grants funded through the MIDAS program and will meet monthly by videoconference or conference call.

The research groups are teams of multidisciplinary, collaborating scientists from one or more institutions who have expertise in fields relevant to MIDAS. Research groups conduct research in computational, mathematical, and engineering approaches to modeling data on emerging infectious diseases.

The Centers of Excellence will provide national and international leadership in four major thematic areas – infectious disease research; computational, statistical, and mathematical research; education and outreach; and public health policy. 

The information technology resource will support and extend the work of the MIDAS Centers of Excellence and research groups by providing the infrastructure and resources for hardening and testing software; collecting, managing, and generating data relevant to the systems they are studying; providing support for dissemination of information and for outreach; and providing logistical support for MIDAS activities.  The resource is expected to act in partnership with the MIDAS Centers of Excellence and research groups.  

Each funded project must make a commitment to focus MIDAS research on specific tasks of national importance and to participate fully in collaborative Network research. The MIDAS Network requires a commitment to cooperative interactions that must be detailed in the application.  Specific domains of interaction can be found in Section IV.6.

Projects funded through MIDAS use existing sequence, genetic, epidemiological, clinical, climate, etc. information to conduct research.  They will not generate primary data, with the exception of synthesized data.    

See Section VI. 2. Administrative and National Policy Requirements, for additional terms and conditions that will be incorporated into the award statement.

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

Section II. Award Information


1. Mechanism of Support

This FOA will use the Cooperative Agreement U54 award mechanism. The Project Director/Principal Investigator (PD/PI) will have primary responsibility 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 and National Policy Requirements, "Cooperative Agreement Terms and Conditions of Award”.  Awards made under this program will continue as Cooperative Agreements throughout the term of award.

2. Funds Available

The estimated amount of funds available for support of three projects awarded as a result of this announcement is 9 million dollars for fiscal year 2009. Future-year amounts will depend on annual appropriations.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

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

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III.  Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions
 
The following organizations/institutions are eligible to apply:

Foreign Institutions are not eligible to apply.  Foreign components are allowable, which is defined as performance of any significant element or segment of the project outside the United States by a researcher employed by a foreign institution.

1.B. Eligible Individuals

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

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Applicants are not permitted to submit a resubmission application in response to this FOA.

Renewal applications are not permitted in response to this FOA.

Applicants may submit more than one application, provided each application is scientifically distinct.

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

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: September 24, 2008
Application Receipt Date: October 24, 2008
Peer Review Date(s): February – March 2009
Council Review Date: May 2009
Earliest Anticipated Start Date: July 1, 2009  

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 in Section IV.3.A.

The letter of intent should be sent to:

James J. Anderson, Ph.D.
Center for Bioinformatics and Computational Biology
NIGMS
45 Center Drive, Room 2AS.25A, MSC6200
Bethesda, MD 20892-6200
Telephone: (301) 594-0943
FAX: (301) 480-2228
Email: andersj@mail.nih.gov

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:

Helen R. Sunshine, Ph.D.
Office of Scientific Review
NIGMS
45 Center Drive, Room 3AN.12F, MSC6200
Bethesda, MD 20892-6200
Telephone: (301) 594-2881
FAX: (301) 594-8506
Email: sunshinh@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/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

6. Other Submission Requirements and Information

NIGMS has adopted several policies that are applicable to the MIDAS Network. Applicants must present plans to adhere to the policies, where appropriate.

Data Sources. Centers and research groups will use existing or simulated datasets, as well as real-time information, to build computational models relevant to the goals of MIDAS. Centers and research groups will not generate primary data, except in the case of simulations.

Relationship to the MIDAS Information Technology Resource. Each Center and research group must identify a data liaison person to interact with the information technology resource. This basic or bioinformatics scientist will advise the information technology resource on the management and display of data generated or used by the Center or research group, and will coordinate any joint software development. 

Databases.  Centers and research groups may develop their own (local) databases to meet their computational needs. They may request funds to support the design, testing, and validation of bioinformatics tools and the storage of data needed to accomplish their research objectives. If necessary and appropriate, each Center and research group will be required to use the standard data exchange format established by the information technology resource for transmitting information among MIDAS projects.

Data, Software, and Intellectual Property. Each Center and research group must propose a data and software release policy (see IV.6. Resource Sharing Plan(s) section (a), Data Sharing Plan, and section (d), Software Development). Each Center and research group must also provide a separate plan that addresses intellectual property rights.  These plans may be further negotiated prior to funding.

Meetings and Reports.  The Principal Investigator of each Center and research group serves as a member of the MIDAS executive committee and will participate in monthly videoconferences or conference calls.  In addition, each Center and research group will present its research findings at annual meetings of the steering committee and at no more than three Network meetings per year.  Funds for travel of the Principal Investigator(s) and relevant staff to these meetings should be included in the proposed budget.  

National Emergencies. In the event of an attack or the emergence of an infectious disease, NIGMS may ask the principal investigators of MIDAS centers and research groups, in concert with the MIDAS information technology resource, to apply their expertise to the public health emergency. Should this occur, NIGMS will be flexible in allowing the Principal Investigator to reorganize and reorient specific project goals and to renegotiate the scope of the grant to include new objectives. The awardee may also be able to request additional funding to cover costs that were not included in the initial application.

Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information".

Research Plan Page Limitations

The page limit for the Research Plan section of the application is 80 pages.  Please note that there is no requirement to submit the maximum number of pages; instead, concise, articulate applications are desired.

Project Plan:

The Center proposal should be organized to include the following components in this order:

1.   Program Summary (include mission, specific aims, and milestones of the Center)

2.   Organizational Structure and Management Plan

3.   Research Projects and Preliminary Studies

4.   Core Facilities, if relevant

5.   Policy Studies 

6.   Training and Education Plan

7.   Outreach and Dissemination Plan

8.   Recruitment and Retention Plan to Enhance Diversity

9.   Plans for Intellectual Property Handling and Data/Resource/Software Sharing

10.  A timeline for the project.  This timeline should outline how the project's goals can be met within the time frame of the grant. The timeline also will assist the investigators, the NIGMS, and its advisors in evaluating progress toward the project's goals.

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. (See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research-findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in 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 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/.

(d) Software Development: Applications must include a statement that software developed through MIDAS funding will be deposited, in a timely manner, in the MIDAS repository maintained by the information technology resource; this repository will have restricted access to MIDAS grantees and Federal agencies.  And, if the MIDAS steering committee recommends that a particular software application should be made available for public use, the applicant will cooperate with the information technology resource in producing and maintaining a user-friendly version.

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

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 NIGMS and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

The following will be considered in making funding decisions:

NIH considers the following in evaluating Center grant applications:

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 meritorious priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will they advance scientific knowledge or clinical practice? 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?  Are policy studies well integrated with the research components?  Is the problem of model validation adequately addressed?   

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?

Cooperation: Does the Center team demonstrate a willingness and capability to work with other members of the MIDAS Network to enhance the MIDAS program’s productivity?

Recruitment and Retention Plan to Enhance Diversity: Does the proposal offer a credible and compelling plan? 

2.A. Additional Review Criteria:

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

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five points described in the Vertebrate Animals section of the Research Plan will be assessed.

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

2.B. Additional Review Considerations

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

2.C. Resource Sharing Plan(s)   

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score. Program staff within the IC will be responsible for monitoring resource sharing.

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 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

Certain policies that pertain to the MIDAS Network will be required. These are listed in Section IV.6, “Other Submission Requirements”.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

2. A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for (a) determining and coordinating research approaches and procedures; (b) setting project milestones for the research group; (c) participating actively in MIDAS meetings, including the executive committee meetings; (d) implementing policies and guidelines approved by the MIDAS steering committee; (e) submitting data and software to the MIDAS repository through the information technology resource according to policies established by the steering committee; (f) attending steering committee meetings; and (g) contributing to the cooperative nature of the effort.  The Project Director/Principal Investigator of the center grant must commit a minimum effort of 30% or 3.6 months per year to the project.

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.

NIGMS Project Scientists with expertise in relevant areas will (a) serve as voting members of the steering committee as representatives of the NIH extramural staff; (b) help guide the development of the MIDAS Network by providing overall advice and coordination; (c) facilitate a partnership among NIH, the Centers of Excellence, research groups, and the information technology resource; (d) ensure that the directions taken by MIDAS are consistent with NIH missions and goals; (e) make recommendations regarding support, to maintain a scientific balance between accomplishing the goal and objectives of MIDAS and addressing emerging research opportunities; and (f) facilitate, not direct, activities.  Decisions will be reached, where possible, through consensus with the principal investigators and the MIDAS steering committee 

Additionally, an agency program official or NIGMS program officer will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

The Program Director is a central contact for all scientific and fiscal issues and serves as a resource to the project regarding DHHS, NIH, and NIGMS recommendations and policies. The Program Director or designate will attend all steering committee meetings but is not a voting member of the steering committee.

2.A.3. Collaborative Responsibilities
 
The MIDAS Network steering committee is the oversight body for MIDAS.  Members, who are appointed by the Director, NIGMS, will include representation from user groups such as public health officials, representatives of the research community, and NIH scientist administrators with relevant expertise. Outside expertise ensures sufficient breadth and balance on the committee. NIH scientist administrators will not comprise more than 40% of the voting members of the steering committee, and may not serve as Chair.

The steering committee decides on the schedule of meetings, once each year, usually in Bethesda, MD. The steering committee may also call meetings to address urgent national needs, and will participate in Network meetings and teleconferences as needed.  The steering committee may establish subcommittees as necessary. The steering committee also may add members, with the approval of the NIGMS Director.

Specifically, the steering committee will (a) serve as the main oversight board of the MIDAS Network; (b) communicate the views and needs of the scientific and public health communities; (c) recommend refinements of software developed by MIDAS researchers to meet public health needs; (d) set overall milestones for MIDAS; (e) assess progress within the MIDAS Network; (f) develop guidelines and policies for data and software sharing and release to public domains; (g) reflect the views of other researchers; (h) contribute to the development of a cohesive effort; and (i) alert NIH to scientific opportunities, emerging needs, and impediments.

2.A.4. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

James J. Anderson, Ph.D. 
Center for Bioinformatics and Computational Biology
NIGMS
45 Center Drive, Room 2AS.25A, MSC6200
Bethesda, MD 20892-6200
Telephone: (301) 594-0943
Fax: (301) 480-2228
Email: andersj@mail.nih.gov

2. Peer Review Contacts:

Helen R. Sunshine, Ph.D.
Office of Scientific Review
NIGMS
45 Center Drive, Room 3AN.12F, MSC6200
Bethesda, MD 20892-6200
Telephone: (301) 594-2881
Fax: (301) 480-8506
Email:sunshinh@mail.nih.gov

3. Financial or Grants Management Contacts:

Ms. Grace Olascoaga
Grants Administration Branch
NIGMS
45 Center Drive, Room 2AN.32C, MSC6200
Bethesda, MD 20892-6200
Telephone: (301) 594-5520
FAX: (301) 480-2554
Email: olascoag@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

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

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

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

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

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

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

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

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


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