Part I Overview Information


Department of Health and Human Services

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

Components of Participating Organizations
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov)

Title:  Non-Injection Drug Abuse and HIV/AIDS (R21)

Announcement Type

This is a new FOA but is a companion R21 to PAS-06-054, which was previously released November 2, 2005.

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

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: PAS-07-262

Catalog of Federal Domestic Assistance Number(s)
93.279   

Key Dates
Release/Posted Date: December 21, 2006
Opening Date: January 5, 2007  (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://grants1.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: January 3, 2009 (now January 8, 2009 per NOT-OD-07-093)

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 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

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

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
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

Purpose

This FOA seeks to understand the contribution of non-injection drug abuse to the acquisition and/or transmission and/or disease progression of HIV/AIDS through use of the R21 mechanism to support new exploratory and developmental research projects.  For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research or the innovative use of an existing methodology to explore a new scientific area.   Specifically, it seeks to: 1) investigate how, where, why, and among whom HIV/AIDS spreads through high-risk sexual behavior associated with non-injection drug use; 2) develop effective prevention interventions and treatment for non-injection drug users at risk for or infected with HIV; and 3) improve accessibility and utilization of evidence-based, integrated care for non-injection drug abuse, risky sexual behavior, and HIV/AIDS and other infectious diseases.  The FOA will support research employing a range of methodological approaches including basic, clinical, epidemiological, prevention, and treatment studies as well as multidisciplinary research in the biomedical, behavioral, and social sciences to contribute to knowledge in these areas.

Background and Significance

Since HIV/AIDS was first identified in the early 1980s, knowledge and understanding about the disease have grown rapidly.  NIH research initiatives contributed to the reduction in the annual number of new HIV infections in the United States from its peak of 160,000 in the mid-1980s to approximately 40,000 new infections by 1990.  However, this annual rate of 40,000 new infections has been relatively stable to the present, which indicates that new research initiatives are needed to improve the effectiveness of HIV prevention and AIDS treatment programs.  Such improvement can only be accomplished by expanding our current knowledge base to be responsive to the dynamic nature of the epidemic.

Early in the epidemic, it became clear that injection drug use (IDU) was a major factor in HIV transmission as reflected by the decision of the US Centers for Disease Control and Prevention (CDC) to include IDU as a main exposure category in its HIV/AIDS Surveillance Reports.  Early in the epidemic, IDU, directly or indirectly (sex with IDU, IDU/MSM, children of IDUs), was associated with over a third of AIDS cases in the United States.  NIDA research explored the risks for HIV and other blood-borne infections associated with syringe and paraphernalia sharing by IDUs and contributed to the development of interventions targeting IDUs.  The success of these efforts is evidenced by the significant decline in the proportion of AIDS cases attributable to IDU over the past several years.

Recent CDC HIV/AIDS surveillance data has revealed shifts in the demographics of populations at risk, with substantial increases in the proportion of new HIV/AIDS diagnoses among women, racial/ethnic minorities, lower income groups, and young men who have sex with men (MSM).  There is, therefore, reason for concern that a resurgence of HIV may be occurring, especially among young MSM and MSM of color. Recent reports indicate that the incidence of HIV in young black MSM is among the highest of all risk groups in the United States.  Although up to 57% of the cumulative AIDS cases among women were previously attributed to injection drug use or sex with partners who inject drugs, heterosexual contact has now become the leading cause of new HIV infections among women, especially within minority communities.  There are many plausible ways that non-injection drug abuse may be contributing to new infections.  Substance abuse may affect judgment and decision-making and lead to high-risk sexual encounters.  High-risk sex increases the prevalence of sexually transmitted diseases such as herpes simplex virus 2, chlamydia, gonorrhea, and syphilis, which are prevalent among sexually active drug users and increase the transmission rates of HIV. The exchange of sex for crack is well documented, and abusers of other non-injection drugs may also engage in risky sex in order to obtain their preferred drug(s).  Furthermore, physiological or immunological effects of non-injection drugs of abuse may alter risks of HIV transmission and/or disease progression.

Given the growing importance of sexual transmission in new HIV infections, it is imperative that research efforts be devoted to disentangling the dynamic behavioral, biological, and environmental processes implicated in the sexual transmission of HIV among drug users. For example, although it is known that among adolescents drug use is preponderantly non-injection drug use and is associated with high-risk sexual behavior, the factors underlying this association have not been fully characterized.  These may include factors such as: 1) interactions of drugs of abuse with the developing brain and the structures responsible for self-regulatory behavior; 2) interactions between drugs of abuse and personality traits such as sensation-seeking; and cognitive processes such as impulsivity; 3) the effect of drugs of abuse on sensitivity to reward and reinforcement, especially those associated with high risk sexual behaviors; 4) social modeling; 5) substance use and high-risk sexual behavior associated with particular settings; and 6) co-morbid adjustment, major affective, or other psychiatric disorders.

An individual’s peers, relationships, social networks, and environment influence both drug abuse and sexual risk taking.  Turnover in relationships and social mixing patterns can create multiple opportunities for the introduction and transmission of infections and for diffusion of new types of drugs, drug use practices, and HIV risk behaviors. For example, young drug users who initiate use of heroin and cocaine with older drug users are at greater risk for sexually transmitted infections; and drug using men on the “down low” (i.e., men who have sex with men and women but do not identify as gay or bisexual or disclose same sex behavior) may transmit HIV and/or STI to their female partners.

Elucidating the extent to which drug use is contributing to new cases of HIV infection will be a complex undertaking.  For example, while numerous studies have linked methamphetamine use in MSM to high-risk sexual behavior, it has only recently been demonstrated that methamphetamine use in MSM is associated with an increased incidence of HIV infection.  Further complicating the establishment of the relationship(s) between non-injection drug use and HIV/AIDS are the multiplicity of non-injection drugs, including club drugs such as MDMA, GHB, ketamine, and methamphetamine, and other non-injection drugs of abuse such as cocaine, opioids, inhalants, and marijuana; and the widespread use of drug combinations. Also, polydrug use (use of multiple drugs but not necessarily in combination) is common.  In addition, drugs are taken via various routes of administration, e.g., smoking, snorting, which produce different pharmacokinetic profiles that may impact risk behavior and/or host factors such susceptibility to infection.  Moreover, the degree of drug use involvement (i.e., use, abuse, or dependence) may affect the nature and magnitude of the role of non-injection drug use in facilitating HIV transmission and/or acquisition or affect a drug user’s ability to adhere to HIV therapy.

Research Scope

The following are examples of broad research topics that are of interest to this FOA, but these topics are not meant to be exclusive of other topics. 

Basic and Clinical Research

Basic and clinical research can facilitate disentangling the relative contribution of drug intoxication and/or the role of various patterns of drug abuse (e.g., class of abused drug, route of administration, chronic versus acute or intermittent use, including effects of withdrawal) on HIV risk behaviors or ability to adhere to HIV treatment regimens.  It is anticipated that basic and clinical neurobiological laboratory studies will enhance our understanding of the complex interrelationships between drug abuse, gender, age, cognitive processes such as impulsivity, personality variables such as sensation-seeking and coping strategies that can lead individuals to engage in risk behaviors associated with HIV transmission.  Basic behavioral, cognitive science, and neurobiological research studies using either animal models or involving laboratory-based research with human volunteers are encouraged to better understand drug abuse effects on the valence of positive and negative reinforcement and punishment, and how these may influence HIV risk behaviors or adherence to HIV treatment.   Neurobehavioral studies may also investigate how drug intoxication or withdrawal states affect impulsivity and decision making, and the processing of rewarding and aversive stimuli that may be associated with high risk sexual behavior. Because of the scarcity of data on the influences of drugs of abuse on sexual arousal or inhibition of sexual arousal, behavioral and neurobiological laboratory studies on these topics are encouraged. 

Moreover, there is growing evidence that in addition to risky behavior, there may be biological interactions between non-injection drugs of abuse and either HIV or host responses to HIV.  For example, studies using cell culture and animal models of both AIDS and neuroAIDS have shown enhanced virus replication and altered host susceptibility to infection following exposure to drugs of abuse including methamphetamine and cocaine, as well as after exposure to dopamine.  Recent human studies suggest that non-injection drug use may accelerate HIV progression and exacerbate neuropathology associated with AIDS, and imaging studies suggest combined effects of HIV infection and non-injection drug use on specific brain regions associated with addiction.  Basic and clinical neuroscience research to identify neurobiological interactions between non-injection drugs of abuse and HIV or host responses to HIV is encouraged.  Such studies may utilize structural or functional brain imaging, genetic analysis of neurobiological systems, and neuropsychological/cognitive performance measures to index the integrity of specific brain systems.  Laboratory studies exploring the mechanisms of biologic interactions, including the involvement of oxidative stress and inflammatory processes in the brain and in the immune system, are also of interest.  Examples include studies of the effects of drugs on viral replication, cell entry, or spread to specific reservoirs including the brain; interactions of drugs and either HIV or HIV-induced cellular responses on cell function including structural and functional adaptive changes of neurons/glial cells/neural networks associated with the progression of HIV encephalopathy; and studies of potential interactions of anti-retroviral therapeutics with any of the above topics.

Research on HIV and Development

Studies are encouraged to examine the effects of exposure to non-injection drugs of abuse (prenatal exposure, passive exposure during childhood, drug use during adolescence and young adulthood) on the development of neural structures, mechanism, circuits, and systems and associated cognitive and emotional processes that are related to HIV risk behaviors.  Research is also needed on neurobiological, cognitive, and behavioral outcomes of youth who have been exposed to non-injection drugs and to HIV/AIDS and/or to antiretroviral therapy (HAART). Exposure to HIV/AIDS includes youth infected with HIV/AIDS and youth exposed in utero to HIV but not infected.  Research is encouraged to characterize non-injection drug use among youth living with and youth affected by HIV/AIDS (that is, youth living with family members, caregivers, peers, or communities with HIV/AIDS).  Studies that examine the role of non-injection drug use on HIV transmission, interaction with HAART therapies, maintenance of health status, and brain and behavioral development for HIV+ youth are also encouraged.

Adolescence is a period of development associated with perceptions of invulnerability and increased experimentation.  These behaviors occur in the context of still-developing biological, cognitive, emotional, and social capacities.  It is important to remember that behaviors that emerge during adolescence as part of normal development, such as an increased likelihood of risk taking and sensation seeking, and the increased prominence of peer relationships and a reduction in parental involvement, can put young people at risk for drug use and its consequences including HIV/AIDS.  The consequences of drug use and HIV/AIDS may in turn affect the developing brain and behavioral systems.  Research is needed to better understand the development of brain and behavioral processes associated with HIV risk behaviors including decision making, self-regulation, impulsivity, and social influence and the effects of non-injection drug use on these brain and behavioral processes.

Epidemiological Research

Studies are encouraged to characterize: 1) the scope and magnitude of HIV/AIDS and other sexually transmitted infections (STDs) among non-injection drug users, sexual partners of drug users, and their peers and social networks; and 2) the influence of specific drug types and/or routes of administration on HIV risk behaviors and relationships within social, drug, and sexual networks, as well as on HIV and STD infection rates.  This includes plans to: (1) identify social, cultural, and community factors and norms that influence the dynamics of risk partnerships, the mixing patterns of network members, and the diffusion and adoption of drug use and sexual risk behaviors associated with HIV and other STDs; (2) advance knowledge of new patterns of non-injection drug use, including predictors of use, the extent of use, and the effects that these drugs may have, singly or in combination with other drugs, on HIV transmission risks; (3) clarify Internet-mediated changes in drug use patterns and sexual encounters, and what these mean for public health and HIV prevention science; and (4) characterize how antiretroviral therapy for HIV-positive non-injection drug users may interact with drugs of abuse, affect willingness to engage in sexual risk behaviors, and change perceptions of risk and vulnerability.

Prevention Research

Studies are encouraged to develop new, theory-based interventions responsive to changing interactions between non-injection drug abuse, sexual risk behaviors, and the spread of HIV and other infectious diseases. Such changes are most evident among high-risk groups and networks, where rapid diffusion of new types and routes of drug use can influence sexual risk behavior and sexual partnerships.  However, the interaction of mental health and substance use disorders in dually-diagnosed youth has also been associated with elevated levels of HIV risk behavior, and suggests the need for research to develop interventions tailored to this unique need.  HIV prevention intervention strategies are encouraged to engage young people vulnerable to HIV, including young MSM, who attend raves or circuit parties, rural heterosexuals with limited resources and access to health care, and those with substance use and mental health co-morbidities.  Research is needed to: 1) develop and test new HIV behavioral prevention interventions to mitigate drug use and the spread of STDs and HIV; 2) improve peer outreach and engagement in HIV prevention interventions; and 3) engage high-risk youth in HIV prevention programs.  For example, the Internet, as an agent of change, may provide an effective mechanism for reaching hard-to-reach drug users and engaging them to participate in HIV prevention interventions as well as drug treatment.  The changing epidemiology of HIV/AIDS risks associated with non-injection drug use requires innovative HIV prevention approaches that are able to address multiple and changing levels of risks with attention to life course (e.g., adolescence, young adulthood), co-occurring health conditions (e.g., mental health disorders) and contexts (e.g., social network, dyadic, family, community, structural). 

Health Services Research

Studies are encouraged to improve the transfer, adoption, and integration of science-based prevention and treatment services for non-injection drug abuse and HIV/AIDS in healthcare and social service settings.  Such services should be coordinated and integrated in order to better respond to changing interactions among non-injection drug abuse, sexual risk behavior, and the spread of HIV and other infectious diseases. A cross-disciplinary research approach may be necessary to better understand the complex ways in which social factors, personal behaviors, financing systems, organizational structures and processes, management practices, and health technologies affect the accessibility, utilization, quality, effectiveness, and cost of integrated care for preventing and treating non-injection drug abuse, risky sexual behavior, and HIV/AIDS and other infectious diseases.  Novel research on the transfer, adoption, and integration of science-based care for these public health problems may address the multidirectional and iterative nature of innovation and practice improvement as well as knowledge transfer, organizational change, and innovative financing strategies.  Examples of such research include:  the identification of models for rapid introduction of science-based integrated care models into existing therapeutic and business practices; the development of alternative strategies for systematic organizational change within healthcare and social service agencies serving non-injection drug users; the identification of improved staff recruitment, training, and supervision procedures for organizations involved in adopting integrated care models or other innovations; the definition of effective decision making processes by payers regarding new models of care for reimbursement;  examination of the impact of managed care on the adoption of integrated models of care for drug abuse and HIV/AIDS; and analyses of the accessibility and costs of alternative integrated intervention materials and associated training and support.

Medical Consequences of Drug Abuse and Co-Occurring Infections

Studies are encouraged on the medical/clinical consequences of non-injection use/abuse of legal (alcohol, tobacco) and illegal drugs (e.g., methamphetamine, MDMA, cocaine, inhalants) and HIV and co-occurring infections including hepatitis, tuberculosis, and sexually transmitted diseases. Research may include studies of: 1) the impact of non-injection substance abuse on medical/health conditions and physiological or biochemical conditions, e.g., nutrition, that might impact the pathogenesis HIV/AIDS; 2) factors that affect resistance and susceptibility to infection; e.g., effects of non-injection drug abuse on mucosal barriers; 3) medical interventions for drug abuse, psychiatric illness,  and HIV and associated clinical conditions; 4) interactions between drugs of abuse and medications to treat drug abuse and pharmacotherapies for HIV/AIDS and comorbid conditions; and 5) pharmacological, physiological, genetic, and clinical factors in progression of infectious diseases in vulnerable and underserved minority populations of non-injection drug users/abusers.

Behavioral Treatment Research

The following Stage I, II, and III Behavioral Treatment Research areas of interest can be viewed within the context of Program Announcement PA-06-486, at http://grants.nih.gov/grants/guide/pa-files/PA-06-486.html.

Stage I Behavioral Treatment Research:

•           Developing, modifying, refining, and improving behavioral interventions, for use within drug abuse treatment, to reduce non-injection HIV risk behavior and improve adherence to HIV therapy.  This includes pilot testing these interventions, and assessing their mechanism(s) of action.

•           Translational research that utilizes basic science findings to develop more potent behavioral interventions, for use within drug abuse treatment, to reduce non-injection HIV risk behavior.

•           Modifying or refining behavioral interventions to reduce non-injection drug abuse risk behavior, within drug abuse treatment, to make them more “community-friendly” (e.g., more accessible, less costly, less intensive, easier to administer, etc.) but similarly or even more potent.

Stage II Behavioral Treatment Research:

•           Testing the efficacy of promising behavioral interventions to reduce non-injection drug abuse risk behavior, within drug abuse treatment, and assessing their mechanism(s) of action, in various populations.

•           Stage III Behavioral Treatment Research:

•           Testing, in community settings, behavioral interventions to reduce non-injection drug abuse risk behavior, within drug abuse treatment, in various populations.

•           Developing methods to train community practitioners to administer efficacious behavioral interventions to reduce non-injection drug abuse risk behavior, within drug abuse treatment.

The evolution and vitality of the biomedical sciences require a constant infusion of new ideas, techniques, and points of view.0 These may differ substantially from current thinking or practice and may not yet be supported by substantial preliminary data. By using the R21 mechanism, the NIH seeks to foster the introduction of novel scientific ideas, model systems, tools, agents, targets, and technologies that have the potential to substantially advance biomedical research.

The R21 mechanism is intended to encourage new exploratory and developmental research projects.  For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research.  Another example could include the unique and innovative use of an existing methodology to explore a new scientific area. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research.

Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism. For example, long-term projects, or projects designed to increase knowledge in a well-established area, will not be considered for R21 awards. Applications submitted under this mechanism should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications. Projects of limited cost or scope that use widely accepted approaches and methods within well established fields are better suited for the R03 small grant mechanism.  Information on the R03 program can be found at http://grants.nih.gov/grants/funding/r03.htm.

Special Considerations

HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse:  Researchers funded by NIDA who are conducting research in community outreach settings, clinical, hospital settings, or clinical laboratories and have ongoing contact with clients at risk for HIV infection, are strongly encouraged to provide HIV risk reduction education and counseling.  HIV counseling should include offering HIV testing available on-site or by referral to other HIV testing service for persons at risk for HIV infection including injecting drug users, crack cocaine users, and sexually active drug users and their sexual partners.  For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html.

National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects:  The National Advisory Council on Drug Abuse recognizes the importance of research involving the administration of drugs to human subjects and has developed guidelines relevant to such research.   Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects.  The guidelines are available on NIDA's Home Page at www.nida.nih.gov under the Funding, or may be obtained by calling (301) 443-2755.

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 NIH Exploratory/Developmental Research Grant (R21) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.  

This FOA uses “Just-in-Time” information concepts. It also uses the modular as well as the non-modular budget formats (see the “Modular Applications and Awards” section of the NIH Grants Policy Statement. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, “Modular Budget Component,” of the Application Guide).

All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.

Exploratory/developmental grant support is for new projects only; competing renewal (formerly “competing continuation”) applications will not be accepted. Up to two resubmissions (formerly “revisions/amendments") of a previously reviewed exploratory/developmental grant application may be submitted. See NOT-OD-03-041, May 7, 2003.  

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.

The total project period for an application submitted in response to this funding opportunity may not exceed 2 years. Although the size of award may vary with the scope of research proposed, it is expected that applications will stay within the budgetary guidelines for an exploratory/developmental project; direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year award period. 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.

F&A costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November 2, 2004.  

All awards are subject to the availability of funds. The estimated amount of funds available for support of 3-7 projects awarded as a result of this announcement is $20,000,000 for fiscal year 2007 for this FOA and its companion R01 and R03. Future year amounts will depend on annual appropriations.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

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

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (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.

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

Section IV. Application and Submission Information


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/Apply/ and follow the directions provided on that Web site.

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

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 Started

2) Organizational/Institutional Registration in the eRA Commons

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

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 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 301-435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).

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 is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include 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: Select one, as appropriate. (See Section IV.6., “Special Instructions,” regarding appropriate required budget component. Research & Related Budget is 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:

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)), 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 not 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: January 5, 2007 (Earliest date an application may be submitted to Grants.gov)

Letters of Intent Receipt Date(s): Not applicable.
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/Apply 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.

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. 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. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an “Introduction” addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).

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 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 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 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. 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 “Registration FAQs – Important Tips -- Electronic Submission of Grant Applications.”

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

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 (MS Word or PDF) are to be followed, incorporating "Just-in-Time" information concepts, and with the following requirements for R21 applications:

Appendix Materials

R21 Appendix materials should be limited, as is consistent with the exploratory nature of the R21 mechanism. The following materials may be included in the Appendix.

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

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

Plan for Sharing Research Data

Not applicable.

Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement  http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., “Reporting.”

Section V. Application Review Information


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

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

2. Review and Selection Process

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

Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://cms.csr.nih.gov/ResourcesforApplicants/) will evaluate applications for scientific and technical merit.

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

The NIH R21 exploratory/developmental grant is a mechanism for supporting novel scientific ideas or new model systems, tools, or technologies that have the potential to significantly advance our knowledge or the status of health-related research.  Because the Research Plan component is limited to 15 pages, an exploratory/developmental grant application need not have extensive background material or preliminary information as one might normally expect in an R01 application.  Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding.  Reviewers will place less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data.  Preliminary data are not required for R21 applications; however, they may be included if available.   

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?

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

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

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

2.A. Additional Review Criteria:

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

Resubmission Applications (formerly “revised/amended” 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 item 6 of the 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 item 7 of the Research Plan component of the SF424 (R&R).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under item 11 of the Research Plan component of the SF424 (R&R) 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.

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. Sharing Research Data

Not Applicable.

2.D. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement  http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

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

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590), See Section VI.3., “Reporting.”

Model Organism Sharing Plan:  Reviewers are asked to assess the sharing plan in an administrative note. The sharing plan itself should be discussed after the application is scored. Whether a sharing plan is reasonable can be determined by the reviewers on a case-by-case basis, taking into consideration the organism, the timeline, the applicant's decision to distribute the resource or deposit it in a repository, and other relevant considerations. For the R21 mechanism, the presence or adequacy of a plan should not enter into the scoring of the application.

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/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


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:

Lynda Erinoff, Ph.D.
AIDS Research Program
National Institute on Drug Abuse
Room 5274, MSC 9581
6001 Executive Blvd.
Bethesda, MD 20892-9581
Telephone: (301) 402-1972
Fax: 301-594-5610
Email: le30q@nih.gov

2. Peer Review Contacts:

Not applicable.

3. Financial or Grants Management Contacts:

Christine Kidd
Grants Management Branch
National Institution on Drug Abuse
6101 Executive Blvd., Suite 270
Bethesda, MD 20892-8403
Telephone: (301) 443-6710
Fax: 301-594-6847
Email: ckidd@ngmsmtp.nida.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 (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 IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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

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

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

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

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

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) 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 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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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