Part I Overview Information

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Department of Health and Human Services

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

Components of Participating Organizations
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov/)
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov)
National Institute of Nursing Research (NINR), (http://www.ninr.nih.gov/)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov/)

Title: Prevention Research with HIV Positive Individuals (R01)

Announcement Type
New

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

• November 27, 2009 - See Notice NOT-MH-10-006 NIMH Announces Changes in NIMH Participation, As of January 8, 2010, NIMH will terminate or withdraw its participation from this FOA.
• May 14, 2008 - See Notice (NOT-NR-08-002) Change in Scientific Contact.
• April 23, 2008 - See Notice (NOT-DA-08-013) Announcing the participation of NIDA.

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Program Announcement (PA) Number: PA-08-107

Catalog of Federal Domestic Assistance Number(s)
93.242, 93.361, 93.865

Key Dates
Release/Posted Date: March 18, 2008
Opening Date: April 7, 2008 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not applicable
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Submission/Receipt Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission/Receipt Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: (New Expiration Date January 8, 2010 per NOT-MH-10-006) Original: January 8, 2011

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

• Purpose. This Funding Opportunity Announcement (FOA) issued by the National Institute Mental Health (NIMH), National Institute of Nursing Research(NINR), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) invites interdisciplinary studies addressing the psychosocial and behavioral consequences of HIV disease. Over the past decade, secondary prevention in HIV disease, or positive prevention , has received a much needed increase in attention. Gains have been made toward the aim of decreasing HIV transmission behaviors and improving quality of life among individuals living with HIV/AIDS, as well as understanding factors that are important to healthy coping. In this program announcement, further opportunities for innovation in this field are indicated.
• Mechanism of Support. This FOA will utilize the NIH Research Project Grant (R01) award mechanism and runs in parallel with FOAs of similar scientific scope, PA-08-108, which solicits applications under the Small Research Grant (R03) mechanism; PA-08-109, which solicits applications under the Exploratory/Developmental (R21) mechanism; and PA-06-248, which solicits applications under the Exploratory Grants for Mental Health Interventions and Services (R34) mechanism. Please note that the participating organizations vary across this set of FOAs.
• Funds Available and Anticipated Number of Awards. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.
• Application Research Plan Component Length: The R01 application Research Plan component of the PHS398 (Items 2-5) may not exceed 25 pages, including tables, graphs, figures, diagrams, and charts. For information on NIH Research Project Grant Award (R01) see: http://grants1.nih.gov/grants/funding/funding_program.htm
• Eligible Institutions/Organizations. Institutions/organizations listed in Section III.1.A are eligible to apply.
• Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization 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.
• Number of PDs/PIs. More than one PD/PI, or multiple PDs/PIs, may be designated on the application.
• Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct.
• Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement).
• Renewals. Applications can be renewed by competing for additional project periods.
• Application Materials. See Section IV.1 for application materials.
• General Information. For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites:
  • SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm
  • General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/
• Hearing Impaired. Telecommunications for the hearing impaired is available at: TTY 301-451-5936.

Table of Contents

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Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism 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. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically to the NIH
C. Application Processing
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
3. Reporting

Section VII. Agency Contacts
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

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Section I. Funding Opportunity Description

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1. Research Objectives

Purpose

This funding opportunity announcement (FOA) calls for research to advance the scientific understanding of secondary HIV prevention, which includes behavioral risk reduction to prevent the further transmission of HIV and prevention of the potentially serious negative psychological consequences of receiving a diagnosis of HIV and living with HIV disease. Thus, research is being solicited to enhance and expand available intervention strategies to promote, improve, and sustain positive adjustment and health outcomes for people living with HIV/AIDS (PLWHA). The overarching emphasis is on the development of innovative behavioral and structural interventions that advance the science for issues such as disclosure of one’s HIV status, HIV stigma reduction, and co-morbid mental and physical disorders for PLWHA. Additional areas that are encouraged include interventions that consider lifetime developmental changes for PLWHA, research in international settings, as well as investigations that capitalize on new opportunities emerging from the Center for Disease Control and Prevention’s (CDC) revised guidelines for HIV testing in the United States. Studies are also needed that will advance knowledge of effective approaches for promoting the dissemination, adoption, and sound implementation of efficacious secondary HIV prevention interventions in real-world community and clinical settings. A well-articulated and empirically based conceptual framework is essential in applications solicited under this announcement. Approaches based on basic behavioral and social scientific principles such as cognition, emotion, decision-making, motivation, social interaction, structural factors, and cultural context are invited. Applications for interdisciplinary and community-collaborative research addressing secondary HIV prevention are also particularly encouraged.

Background

Since the advent of effective antiretroviral therapy (ART) for HIV/AIDS, biomedical and behavioral science advances have contributed to: longer lives for people living with HIV/AIDS (PLWHA); enhanced coping and quality of life; and reducing HIV transmission behaviors. However, new challenges and opportunities have emerged. For example, upon learning their HIV status, many PLWHA reduce their risk behaviors; yet, a significant minority still report unprotected behaviors and need additional help to sustain risk reduction over their lifetime (Marks et al., 1999, Kalichman, 2000).

Over the past decade, advances have been made in the development of efficacious interventions that help PLWHA initiate and sustain risk reduction behaviors. Currently, for PLWHA, there are interventions with demonstrated efficacy for individuals who self-identify as heterosexual, bisexual, gay, men who have sex with men (MSM), youth, and families infected and affected by HIV (for example, see http://www.effectiveinterventions.org). Efficacious intervention modalities include individual and group format, and have differing levels of intensity in terms of number and duration of sessions. Several of these interventions are being distributed through the CDC Disseminating Evidence Based Interventions (DEBI) project. This funding announcement also encourages research to translate, enhance and/or extend these findings.

Although there is a growing set of risk reduction interventions for PLWHA with proven efficacy, the current menu of interventions does not address all needs nor reach all those who require risk-reduction assistance (Crepaz et al., 2006). For example, the segments of the population in the United States demonstrating the greatest increase in new cases of HIV include African-Americans; however, there are few interventions with demonstrated efficacy specifically tailored to the needs of PLWHA from this demographic group.

In addition, as living with HIV has become more akin to living with a chronic illness, research is needed that include factors associated with improved physical and psychological functioning of PLWHA while continuing to attend to those factors that help PLWHA initiate and maintain risk reduction behaviors. As the social context of risk and coping change over time, advances in the science of secondary HIV prevention have shed light on factors that may pose challenges to the continued effectiveness of behavioral interventions and present new opportunities for research.

For example, the next generation of intervention research tools may need to better address the shifts in risk-reduction behavior that are occurring among PLWHA. Strategies that are increasingly reported involve identification of same serostatus partners (serosorting) for partner selection, and using information about level of viral load and treatment status for self and partner(s) to inform the use or nonuse of barrier protection (Catz et al., 2001; Elford, 2006; Kalichman et al., 2006). Even among couples in which one or both partners are known to be HIV positive, the desire for parenthood is often strong. There are no currently accepted methods for achieving pregnancy while eliminating the risk of HIV transmission. Thus, individuals and couples desires to be parents remain a critical context for HIV prevention efforts. It will be important to more fully understand these cognitions and behaviors, and whether they are appropriate targets for intervention; their validity as intervention trial outcomes; as well as their impact on HIV transmission rates.

In addition to interventions aimed at reduction of risk behavior, the efficacy of and access to ART has produced dramatic declines in HIV/AIDS-related mortality in nations where ART is widely available. In turn, this means PLWHA are living longer and a shift has been made from sustaining life to providing quality of life. Co-morbid conditions, both psychological and physical, have received relatively less attention in this scientific arena and may impact the efficacy and effectiveness of prevention interventions. For example, psychosocial (e.g., depression, substance use) and physical (opportunistic infections, cancer, heart disease) illnesses may differentially impact PLWHA. Research is needed that targets individuals with co-morbid conditions to address such factors as behavioral risk reduction, coping with multiple disorders, and linkages to care.

Another understudied area of research includes the potential benefits (e.g., increased social support, increase in risk reduction behavior) and risks (e.g., violence, discrimination, and social isolation) associated with disclosure of HIV status, particularly among vulnerable subpopulations (e.g., adolescents, young adults, minority individuals) of PLWHA. Despite widespread agreement in the scientific and clinical community of the importance and challenges of disclosure, numerous descriptive studies of the perceptions and experiences of PLWHA on this topic, and some understanding of the factors that affect HIV serostatus disclosure, the research conducted to date in this area remains limited in significant ways. There have been anecdotal reports from the field of an association between non-disclosure of HIV status and non-adherence to ART, particularly in international settings; however, this remains an understudied area. Furthermore, although serostatus disclosure and fears of HIV stigma may have conceptual and practical overlap, there are understudied aspects of disclosure that warrant further investigation.

Although HIV stigma (or perceived stigma) may play a role in delays in treatment seeking, lack of social support, and increased social isolation for PLWHA, few efficacious interventions to reduce HIV stigma have been developed and tested. Given the potential impact of HIV stigma on a multitude of factors, ranging from health related (e.g., connections to care) to social (e.g., housing stability, social isolation), research addressing HIV stigma from multiple levels (e.g., individual, familial, community, society) is warranted.

Including the research opportunities identified above, there are some additional overarching considerations that reflect the changing landscape of secondary HIV prevention. These issues include understanding the impact of HIV over the lifespan for PLWHA, fostering additional international research to inform, extend and enhance the current state of secondary prevention science, and changes in health policy (particularly with regard to HIV testing). First, the fact that individuals are living longer with HIV disease due to advancements in treatment has lead to a greater need for understanding prevention over the lifespan. Second, in international settings the research to date is even more limited regarding the issues of co-morbid conditions, disclosure, and stigma. Finally, in terms of policy, the revised guidelines for HIV testing recommend routine opt-out testing in all health care settings where a significant number of new cases of HIV might be identified (which would include many emergency rooms, hospitals, correctional health care settings, primary care clinics). If implemented as recommended, this policy change could increase the numbers of individuals who get tested for HIV, which may serve to identify new cases of HIV, and link those individuals who test positive to care more rapidly.

Research Scope

This FOA calls for a broad range of research that will help PLWHA achieve and maintain HIV risk-reduction behaviors, psychological well-being, and physical health. A set of key challenges and opportunities are outlined below. It is likely that the new generation of research addressing the needs of PLWHA will include the development of new interventions, tailoring of already established interventions and the dissemination of efficacious interventions to ensure wide-spread use in real-world settings. These themes are included in all of the priorities outlined in this program announcement. Although each area is discussed independently, research on the efficacy of integrating interventions targeting multiple factors is also encouraged. This list of priority areas is neither comprehensive nor restrictive; it is offered to stimulate critical thinking and innovative approaches in the area of secondary HIV prevention.

REDUCING HIV TRANSMISSION BEHAVIORS

• Research that develops and evaluates novel preventive interventions that target HIV-positive individuals and/or communities that have been previously understudied (e.g., minority, rural, prison populations).

• Research that develops and evaluates recruitment strategies and interventions for PLWHA who do not meet clinical criteria for initiation of ART and thus may appear in treatment settings infrequently.

• Research on partner selection and relationship dynamics, including partner choice (e.g., serosorting), relationship formation and development, partner stability over time, and the impact of these factors on risk behavior. In addition, examination of how time since diagnosis and the introduction of ART impacts partner dynamics and HIV risk behavior.

• Within the context of health care provision for PLWHA, opportunities exist to integrate prevention and treatment efforts. Studies are encouraged to examine integration of prevention into treatment settings, or integration of treatment services into venues providing preventive interventions.

• Develop and test interventions at the provider level, to modify the practice behaviors and decision-making process of health care providers to improve the quality of screening, counseling, and treatment services for HIV positive persons.

• Research on ways to increase the potency and sustainability of intervention effects. For example, interventions that include a menu of options that allow for tailoring of the intervention to the intensity level needed by different participants.

• Research investigating ways to increase retention in behavioral intervention trials. For example, assessment and intervention strategies to increase the readiness of participants to engage in interventions and enhance their participation once enrolled.

• Behavioral intervention studies that include HIV seroincidence or STD incidence data and/or other biologic markers as outcome measures, where appropriate and feasible.

DISCLOSURE OF HIV SEROSTATUS

• Studies examining the impact of disclosure and potential positive and negative outcomes among PLWHA, including, but not limited to risk behavior, intimate partner violence, mental health and self- care (e.g., health care utilization, employment, social support seeking).

• Develop and test interventions for appropriate HIV status disclosure to partners, family members, supportive others, and health care providers which optimizes the likelihood of positive outcomes.

• Innovative approaches to understand the role of disclosure in recruitment for clinical trials research, and the potential of disclosure interventions to enhance participation in clinical research.

HIV STIGMA

• Research to develop and test interventions to reduce HIV stigma at multiple levels: individual, community, society, in a variety of settings including health care, educational, and religious.

• Studies investigating the impact of stigma interventions on HIV testing, risk reduction, adherence behavior and mental health.

• Studies of the impact of stigma reduction on housing instability, employment, family functioning and utilization of health care and social services for PLWHA and their families.

• Studies that seek to understand the intersection or combination of different types of stigma (racism, homophobia, economic and gender inequity) with HIV stigma.

CO-MORBID CONDITIONS IN PLWHA

• Innovative approaches to reach, engage and retain PLWHA and to provide tailored interventions to address co-morbid conditions in settings that have received less attention (e.g., mental health clinics, substance use treatment clinics, primary care settings).

• Studies to adapt and tailor efficacious prevention interventions for PLWHA who are multiply-diagnosed, particularly persons with psychiatric diagnoses (e.g., severe mental illness, depression, trauma, substance abuse disorders) and/or physical disorders (e.g., STIs, sickle cell, cancer, cardiovascular disease).

• Studies that design and test approaches to prevent the onset or exacerbation of co-morbid conditions (e.g., mental disorders, physical disorders) that have been found to disproportionately impact PLWHA.

• Research to understand and develop strategies to improve linkages, coordination, and integration of the following services with primary medial care; drug, alcohol and mental health treatments; STI treatments; reproductive health and family planning services, and other social services for PLWHA.

DEVELOPMENTAL CONSIDERATIONS

• Interventions for PLWHA that address developmental characteristics such as age, time since diagnosis, disclosure of sexual orientation, and other contextual factors (e.g., living arrangements) that may change over time.

• Studies that investigate transition periods in human development, as they relate to risk reduction, health related quality of life, disclosure, stigma and reproductive health. These periods would include, but are not limited to, transition from adolescence to young adulthood and adulthood to older adulthood.

INTERNATIONAL SETTINGS

• Studies that leverage the infrastructure created by the roll-out of ART, PMCT programs and HIV testing to investigate organizational and socio-political processes by which these programs are scaled up and identify, develop and test approaches to integrated interventions that will benefit PLWHA.

• Studies that integrate assessment of co-morbid conditions (psychiatric or physical) and HIV and develop culturally congruent interventions to address risk reduction, coping and quality of life among PLWHA internationally.

• Studies that address issues of serostatus disclosure and seek to reduce stigma on the individual, provider, and community levels to increase service uptake.

• Opportunities exist to study interventions developed in the U.S. in other countries through dissemination, implementation, and operational research. As well, the international context provides unique opportunities to study interventions developed in those settings that could inform prevention efforts for PLWHA domestically. Such studies would capitalize on lessons learned from intervention tailoring, cultural considerations, rapid scale-up, and sustainability issues.

RESEARCH ADDRESSING CHANGES IN U.S. HIV-TESTING POLICY

• In the context of HIV testing expansion, understanding the cognitive, emotional and behavioral factors that are associated with longitudinal risk behavior reduction, from receipt of HIV diagnosis over extended periods of time.

• Studies of patient responses (e.g., psychological, behavioral) to learning serostatus in the context of opt-out testing protocols.

• Research on health care provider responses to opt-out testing and potential ways opt-out testing influences the providers practices of delivery of HIV diagnoses and providing linkages to HIV treatment.

• Interventions to address disclosure issues when HIV diagnosis occurs in non-HIV health care settings.

• Studies investigating the effects of repeat HIV testing on HIV risk behavior.

• Research utilizing Health Information Technology systems to reduce risk behavior, increase positive adjustment, or increase disclosure to partners, and to enhance, sustain or better integrate services and care for PLWHA.

DISSEMINATION, ADAPTATION, IMPLEMENTATION, AND OPERATIONAL SECONDARY PREVENTION RESEARCH

• Development and testing of different modes for transferring efficacious interventions into community and clinic-based settings, especially for service delivery systems targeting rural, minority, and/or other underserved populations.
  
  
• Studies of systemic interventions to influence organizational structure, climate, and culture, in order to promote organizational readiness and capacity for intervention dissemination and adoption.

• Studies to enhance understanding and measurement of fidelity to efficacious behavioral interventions.

• Assessment of changes in organizational leadership, staff turnover, agency instability, and organizational size and how these factors affect implementation, effectiveness, and sustainability of new interventions.

• Studies linking organizational factors (e.g., staff retention and satisfaction) to individual outcomes (e.g., service utilization, HIV testing uptake, reduced risk behavior) using multi-level, multi-method approaches.

• Understanding and intervening on factors that affect agency capacity to sustain an intervention (e.g., intervention complexity, cost and other service-related issues, personnel).

• Study of organizational factors that may be related to an organization’s capacity to conduct ongoing outcomes assessment of an intervention, and adjust practice according to these outcomes.

REFERENCES

Marks, G; Burris, S; Peterman, TA. Reducing sexual transmission of HIV from those who know they are infected: the need for personal and collective responsibility. AIDS 1999, 13:297-306

Kalichman, SC. HIV transmission risk behaviors of men and women living with HIV-AIDS: prevalence, predictors, and emerging clinical interventions. Clinical Psychology: Science and Practice, 2000, 7:32-47.

Crepaz, N; Lyles, CM; Wolitski, RJ; Passin, WF; Rama, SM; Herbst, JH; Purcell, DW; Malow, RM; Stall, R and the HIV/AIDS Prevention Research Synthesis (PRS) Team. Do prevention interventions reduce HIV risk behaviours among people living with HIV? A meta-analytic review of controlled trials. AIDS 2006: 20:143-157.

Elford, J. Changing patters of sexual behavior in the era of highly active antiretroviral therapy. Current Option in Infectious Diseases 2006: 19: 26-32.

Kalichman, SC; Eaton, L; Cain, D; Cherry, C; Pope, H; Kalichman, M. HIV treatment beliefs and sexual transmission risk behaviors among HIV positive men and women. Journal of Behavioral Medicine 2006, 29:401-410.

Catz, SL; Meredith, KL; Mundy, LM. Women’s HIV transmission risk perceptions and behaviors in the era of potent antiretroviral therapies. AIDS Education and Prevention 2001, 13:239-251.

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

Section II. Award Information

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1. Mechanism of Support

This Funding Opportunity Announcement (FOA) will use the NIH Research Project Grant (R01) award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses Just-in-Time information concepts (see SF424 (R&R) Application Guide). It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, a U.S. organization submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs) should use the PHS398 Modular Budget component.

U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component.

2. Funds Available

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 Institutes and Centers (ICs) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

F&A 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

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1. Eligible Applicants

1.A. Eligible Institutions

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

• Public/State Controlled Institution of Higher Education
• Private Institution of Higher Education
• Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
• Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education)
• Small Business
• For-Profit Organization (Other than Small Business)
• State Government
• U.S. Territory or Possession
• Indian/Native American Tribal Government (Federally Recognized)
• Indian/Native American Tribal Government (Other than Federally Recognized)
• Indian/Native American Tribally Designated Organization
• Non-domestic (non-U.S.) Entity (Foreign Organization)
• Hispanic-serving Institution
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Regional Organization

1.B. Eligible Individuals

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

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach that clearly does not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for multiple PD/PI grants will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PD/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Competitive supplements and renewals of grants awarded under this FOA are allowed.

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

Section IV. Application and Submission Information

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To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/applicants/apply_for_grants.jsp and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

• Grants.gov (http://www.grants.gov/applicants/get_registered.jsp) and
• eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm)

PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Registered

• Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
• If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
• The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
• Direct questions regarding Grants.gov registration to:
  Grants.gov Customer Support
  Contact Center Phone: 800-518-4726
  Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
  Email [email protected]

2) Organizational/Institutional Registration in the eRA Commons

• To find out if an organization is already Commons-registered, see the "List of Grantee Organizations Registered in NIH eRA Commons.
• Direct questions regarding the Commons registration to:
  eRA Commons Help Desk
  Phone: 301-402-7469 or 866-504-9552 (Toll Free)
  TTY: 301-451-5939
  Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
  Email [email protected]

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

• The individual(s) designated as PDs/PIs on the application must also be registered in the NIH eRA Commons. In the case of multiple PDs/PIs, all PDs/PIs must be registered in the eRA Commons prior to the submission of the application.
• Each PD/PI must hold a PD/PI account in the Commons. Applicants should not share a Commons account for both an Authorized Organization Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have both a PD/PI role and an Internet Assisted Review (IAR) role, both roles should exist under one Commons account.
• When multiple PDs/PIs are proposed, all PDs/PIs at the applicant organization must be affiliated with that organization. PDs/PIs located at another institution need not be affiliated with the applicant organization, but must be affiliated with their own organization to be able to access the Commons.
• This registration/affiliation must be done by the AOR/SO or their designee who is already registered in the Commons.

Both the PD/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo: Telephone 301-710-0267, Email: [email protected].

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

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget or Research & Related Budget, as appropriate (See Section IV.6., Special Instructions, regarding appropriate required budget component.)
Research & Related Budget (required for foreign applications)

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

Foreign Organizations (Non-domestic (non-U.S.) Entity)

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.

Applications from foreign organizations must:

• Request budgets in U.S. dollars.
• Prepare detailed budgets for all applications (that is, complete the Research & Related Budget component of the SF424 (R&R) application forms not the PHS398 Modular Budget component). See NOT-OD-06-096.
• Charge back of customs and import fees is not allowed.
• Format: Every effort should be made to comply with the format specifications, which are based upon a standard U.S. paper size of 8.5 x 11 within each PDF.
• Funds for up to 8% administrative costs (excluding equipment) may be requested. See NOT-OD-01-028, March 29, 2001.
• Organizations must comply with Federal/NIH policies on human subjects, animals, and biohazards.
• Organizations must comply with Federal/NIH biosafety and biosecurity regulations. See Section VI.2., Administrative and National Policy Requirements.

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs

When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the Contact PD/PI should be entered in item 15 of the SF424(R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan (section 14 of the Research Plan Component in the SF424 (R&R) or Section I of the Research Plan in the PHS 398), must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Applications Involving a Single Institution

When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.

When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are note required when using the Modular budget format. See Section 5.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: April 7, 2008 (Earliest date an application may be submitted to Grants.gov)
Application Submission/Receipt Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission/Receipt Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.

• If everything is acceptable, no further action is necessary. The application will automatically move forward for processing by the Division of Receipt and Referral, Center for Scientific Review, NIH, after two business days.
• Prior to the submission deadline, the AOR/SO can Reject the assembled application and submit a changed/corrected application within the two-day viewing window. This option should be used if the AOR/SO determines that warnings should be addressed or if information was lost or compromised during transmission. Reminder: warnings do not stop further application processing. If an application submission results in warnings (but no errors), it will automatically move forward after two business days if no action is taken. Please remember that some warnings may not be applicable or may need to be addressed after application submission.
• If the two-day window falls after the submission deadline, the AOR/SO will have the option to Reject the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn t transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue.
• If the AOR/SO chooses to Reject the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted, but it will be subject to the NIH late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment.
• Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two days.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR receives the Grants.gov acknowledgments. The AOR and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.

The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the previous critique.

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.

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 renewal (formerly 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 renewal award.

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

6. Other Submission Requirements

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD/PI(s) to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

PHS398 Research Plan Component Sections

Page limitations of the PHS398 Research Plan component must be followed as outlined in the SF424 (R&R) Application Guide. While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

Specific Instructions for Applications Requesting $500,000 (direct costs) or More Per Year

Applicants requesting $500,000 or more in direct costs for any year (excluding consortium F&A costs) must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study;

2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and,

3) Include the PHS398 Cover Letter component with the application to identify the staff member and IC who agreed to accept assignment of the application.

This policy applies to all new, renewal, revision, or resubmission applications. See NOT-OD-02-004, October 16, 2001.

Appendix Materials

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

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

Foreign Applications (Non-domestic (non-U.S.) Entity)

Indicate how the proposed project has specific relevance to the mission and objectives of the IC and has the potential for significantly advancing the health sciences in the United States.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.)

(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact (see Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.)

(b) Sharing Model Organisms: Regardless of the amount requested, all applications in which 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 (e.g., 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 (NOT-OD-07-088) and http://grants.nih.gov/grants/gwas/.

Section V. Application Review Information

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1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

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

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to the ICs on the basis of established PHS referral guidelines.

Applications that are complete will be evaluated for scientific and technical merit by (an) appropriate scientific review group(s) in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.

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

• Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.
• Receive a written critique.
• Receive a second level of review by the appropriate national advisory council or board.

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:

• Scientific merit of the proposed project as determined by peer review.
• Availability of funds.
• Relevance of program priorities.

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? For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs??

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

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

Environment: Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment(s), 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:

Resubmission Applications: Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

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 Human Subjects Sections of the PHS398 Research Plan component of the SF424 (R&R).

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 Human Subjects Sections of the PHS398 Research Plan component of the SF424 (R&R).

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 and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. The priority score should not be affected by the evaluation of the budget.

Applications from Foreign Organizations: Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed.

2.C. Resource Sharing Plan(s)

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

• Data Sharing Plan. [http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm]
• Sharing Model Organisms. [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html]
• Genome Wide Association Studies (GWAS). [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html]

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information

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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 NIH 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.

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 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 and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

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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 Contact(s):

Cynthia I. Grossman, Ph.D.
Center for Mental Health Research on AIDS
Division of AIDS and Health and Behavior Research
National Institute of Mental Health
6001 Executive Boulevard, Room 6199, MSC-9619
Bethesda, MD 20892-9619
Telephone: (301) 443-8962
Fax: (301) 443-9719
Email: [email protected]

Jeanette Hosseini, PhD
Program Director, Office of Extramural Activities
National Institute of Nursing Research, NIH
6701 Democracy Blvd., Suite 710
One Democracy Plaza
Bethesda, MD 20892-4870
Telephone: (301) 594-5972
Fax: 301-480-8260
Email: [email protected]

Susan Newcomer, Ph.D.
Demographic and Behavioral Sciences Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Blvd., Rm. 8B07G
Bethesda, MD 20892-7510
Telephone: (301) 435-6981
Email: [email protected]

2. Peer Review Contact(s):

Not Applicable

3. Financial/Grants Management Contact(s):

Rita Sisco
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2805
FAX: (310) 443-6885
Email: [email protected]

Kelli Oster
National Institute of Nursing Research
6701 Democracy Boulevard, Room 710, MSC 4870
Bethesda, MD 20892-4870
Telephone: (301) 594-2177
FAX: (301) 451-5651
Email: [email protected]

Christy Leake
Grants Management Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Blvd., Rm. 8A17O
Bethesda, MD 20892-7510
Telephone: (301) 496-1305
Email: [email protected]

Section VIII. Other Information

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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 (45 CFR 46) 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 institutional review board (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/.

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. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal 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.

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.

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 SF424 (R&R) application; 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, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). 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 (HHS) 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 HHS 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) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

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 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 Part 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 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/.