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)
National Institute of Nursing Research (NINR) (http://www.ninr.nih.gov)

Title: HIV/AIDS, Drug Use, and Vulnerable Populations in the US (R01)

Announcement Type
New

Update: The following updates relating to this announcement have been issued:

• September 10, 2012 - This PA has been reissued as PA-12-281.
• September 29, 2010 (NOT-OD-11-007) - NIH to Require Use of Updated Electronic Application Forms in 2011. Adobe B1 forms are required for due dates on or after May 8, 2011.
• November 23, 2009 - This FOA has been updated to reflect the new requirements from NIH’s Enhancing Peer Review Initiative. The new requirements are effective for submissions intended for due dates January 25, 2010 and beyond. If submitting an application intended for a due date of January 25, 2010 and beyond, follow the guidance below and be sure to use the Adobe-Forms-B version of the application forms and instructions. If applying for a due date before January 25, 2010, follow the guidance in the archived version of this FOA and be sure to use the Adobe-Forms-A version of the application forms and instructions.

Program Announcement (PA) Number: PA-09-236

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 (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.279, 93.361

Key Dates
Release/Posted Date: July 22, 2009
Opening Date: August 7, 2009 (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 Due Date(s): Standard dates apply, please seehttp://grants1.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due 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: September 8, 2012

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

• Purpose. This FOA issued by the National institute on Drug Abuse and the National Institute of Nursing Research, National Institutes of Health, encourages Research Project Grant (R01) applications to identify the role(s) that drug abuse plays in fueling the HIV/AIDS epidemic in vulnerable groups (racial/ethnic minorities, men who have sex with men, youth) in the United States and to develop effective interventions to prevent new infections and to improve the health and well-being of those living with HIV/AIDS. It is essential to understand the factors (biological, behavioral, psychosocial, environmental, institutional, etc.) responsible for the profoundly disproportionate burden of HIV/AIDS among vulnerable groups. This FOA will support studies to: 1) understand the contribution of drug abuse (both injection and non-injection) to the acquisition and/or transmission of HIV; 2) study disease progression and disease outcomes; 3) develop and/or improve prevention and treatment interventions; 4) address organizational, structural, and/or community level factors including social, drug-using, and sexual networks.
• Mechanism of Support. This FOA will utilize the R01 grant mechanism and runs in parallel with a FOA of identical scientific scope, PA-09-237, that encourages applications under the R21 mechanism.
  
• 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.
• Budget and Project Period. The total project period for an application submitted in response to this funding opportunity may not exceed 5 years. Applicants for an R01 award are not limited in dollars but need to reflect the actual needs of the proposed project.
• Application Research Strategy Length: The (R01) application Research Plan component of the PHS398 may not exceed 12 pages, including tables, graphs, figures, diagrams, and charts. 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). Include 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 (i.e., multiple PDs/PIs), may be designated on the application.
• Number of Applications. Applicants may submit more than one application, provided that 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). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).
• Renewals. Applicants may submit a renewal application under this FOA.
• Application Materials. See Section IV.1 for application materials.
  All applications, including resubmission, revision and renewal, submitted for due dates January 25, 2010 and beyond, must utilize the current forms and instructions.
• 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 are available at: TTY: (301) 451-5936

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. 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

Section I. Funding Opportunity Description

1. Research Objectives

Purpose

After nearly three decades, the HIV/AIDS epidemic in the U.S. continues to evolve, and the role of drug abuse in fueling the epidemic has also evolved. Despite progress in HIV/AIDS treatment and prevention and reductions in HIV/morbidity and mortality, HIV/AIDS health disparities remain a challenge that must be addressed. This announcement encourages research to identify the role(s) that drug abuse plays in fueling the epidemic in vulnerable groups and to develop effective interventions to prevent new infections and to improve the health and well-being of those living with HIV/AIDS. To do this, it is essential that research be directed toward understanding the factors (biological, behavioral, psychosocial, environmental, institutional, etc.) responsible for the profoundly disproportionate burden of HIV/AIDS among vulnerable groups (racial/ethnic minorities, men who have sex with men, youth) in the United States.

This Funding Opportunity Announcement (FOA) will support studies in vulnerable populations to: 1) understand the contribution of drug abuse (both injection and non-injection) to the acquisition and/or transmission of HIV; 2) study disease progression and disease outcomes; 3) develop and/or improve prevention and treatment interventions; 4) address organizational, structural, and/or community level factors including social, drug-using, and sexual networks.

Background

CDC has recently developed more precise estimates of the number of new HIV infections. These new estimates highlight the disproportionate rates of new infections among racial/ethnic and sexual minorities. Unfortunately, some of the most vulnerable populations for HIV infection do not see themselves as being at risk. For example, African American men who have sex with men (MSM) have similar, sometimes lower levels of risk behavior than their white counterparts, yet much higher rates of infection. Similarly, African American women typically do not engage in high levels of risk behavior but are more often exposed to risky partners than women in other ethnic/racial groups. The high prevalence of HIV/AIDS in minority communities increases the risk of transmission because transmission depends on the reservoir of infection (i.e., HIV prevalence) as well as the levels of risk behaviors that transmit infection. HIV/AIDS risk behaviors, in turn, are influenced by economic, social, and political systems that reinforce socioeconomic disparities.

While HIV incidence is down from its high point in the 1980s; the number of new infections remains unacceptably high. Since the 1990s, the number of new infections has remained relatively stable, but there have been changes in the number of new infections associated with each transmission category. There has been a large reduction in the number of new infections attributable to injection drug use. Between 1988-90 and 2003-06 infections in IDUs declined 80%. In 2006, IDUs accounted for only 12% of new HIV infections; attesting to the effectiveness of ongoing prevention efforts among IDU. In 2006, MSM accounted for 53% of new infections. HIV incidence in MSM has increased steadily since 1990.

Young minority MSM are at especially high risk. In 2006, MSM aged 13-29 accounted for 38% of new infections among all MSM; 25% of new infections among white MSM, 52% among black MSM, and 43% among Latino MSM. New infections in white MSM occurred at later ages, the largest number (35%) of new infections among white MSM occurred among 30-39 year olds, followed by those 40-49 years old.

High risk heterosexual contact accounted for 31% of new infections in 2006 and is the principal transmission category for women. Heterosexual transmission accounted for 80% of new infections overall in women, 70% among white women, 83% among African American women, and 83% among Latinas.

The rate of new infections among non-Hispanic blacks was 7 times the rate among whites (83.7 versus 11.5 new infections per 100,000). Blacks accounted for 45% of new infections. The rate of new HIV infections among Hispanics was 3 times the rate among whites (29.3 versus 11.5 per 100,000), and Hispanics accounted for 17% of new infections. While the absolute numbers of infections are small, data suggest that Asians/Pacific Islanders accounted for roughly 2% of new infections, and American Indians/Alaska Natives accounted for roughly 1% of new infections. More new infections (34%) occurred in people under age 30 (ages 13-29) than any other age group; the next highest group (31%) was the 30-39 age group.

Many HIV positive individuals are unaware of their serostatus because they have not been tested for HIV recently. CDC estimates that 21% of those infected with HIV are unaware of their serostatus. These individuals may continue to engage in high risk behavior and unknowingly transmit HIV to others. In addition, those with undiagnosed infection are unlikely to receive treatment early in their disease; indeed, many do not learn their serostatus until they receive a diagnosis of AIDS. Blacks account for nearly half (48.6%) of HIV+ persons unaware of their serostatus; whites account for 30.9%, and Hispanics account for 18.0 % of individuals living with undiagnosed HIV. MSM represent more than half (53.7%) of undiagnosed infections.

Those who are diagnosed with AIDS within one year of testing positive for HIV are referred to as late testers. Thirty-five per cent of African Americans, 41% of Hispanics, and 34% of whites were late testers. Although IDUs were more likely to have been diagnosed than those in other transmission categories, a significantly larger proportion of IDU were late testers compared to other transmission categories. Late diagnosis and entry to care is associated with poorer survival.

There are often stark disparities in death rates from HIV disease. For example, death rates for HIV disease in white women (25-54 years of age) are one tenth those seen in African American women. Part of this is accounted for by African Americans taking longer to seek medical care and having lower CD4+ cell counts at the time of diagnosis. Furthermore, even minorities in care are less likely to receive highly active antiretroviral therapy (HAART) and less likely to adhere to HAART. Increased non-adherence to HAART is strongly associated with increased mortality. Active drug use is contributes to non-adherence. In addition, differences in comorbid medical conditions and pharmacogenomic differences in medication efficacy or toxicity may all contribute to disparate outcomes.

Research Scope

A range of methodological approaches including basic, clinical, epidemiological, prevention, and treatment research as well as multidisciplinary studies are needed to address the complex interplay of biomedical, behavioral, and social factors that lead to HIV/AIDS disparities among vulnerable populations.

This FOA includes, but is not limited to, the types of studies described below:

Epidemiological Research

Studies are encouraged, but not limited to:

• Characterizing the scope and magnitude of HIV/AIDS and other sexually transmitted infections (STDs) among both injection and non-injection drug users, their sexual partners, peers, and social networks;
• Understanding how specific drug types, drug combinations, and/or routes of drug administration influence vulnerabilities for HIV and other STDs;
• Assessing the contributions and interactions of social, cultural, economic, and community factors, norms, and attitudes to the development and/or perpetuation of fears of discrimination and stigma related to ones ethnic/racial identity, sexual identity, friends and partners, substance abuse, physical and mental health, and HIV serostatus;
• Characterizing changing patterns of drug use, including predictors of use, the extent of use, and transitions between non-injection and injection drug use, as well as the association between changing patterns of drug use and HIV risk;
• Examining the role of the Internet and social networking websites on attitudes, perceptions, and norms related to drug use, sexual behavior, partnership formation, and social networking;
• Exploring how advances in and availability of antiretroviral therapies for HIV/AIDS, including pre- and post-exposure prophylaxis, influence attitudes and perceptions about HIV disease, willingness to discount the risks of becoming infected, or perceptions about the risks and vulnerabilities for HIV among social networks;
• Characterizing disparities in the incidence, prevalence, and correlates of HIV and other STDs, including those that result from and/or influence an individuals social mixing patterns; choice of friends, peers and networks; vulnerabilities to acquire and use drugs; psychosocial stress and mental health; sexual partnerships and familial relationships; and access to/use of community-based health and social service programs;
• Disentangling social, cultural, geographic, and environmental factors associated with the disproportionate rates of HIV incidence and prevalence among U.S. ethnic/racial minority groups to facilitate the development of community-based participatory research, to create new outreach, prevention, and HIV/AIDS and drug abuse treatment interventions;
• Examining the role that stigma, including perceived stigma, fear of discrimination, and fear of retribution from ones family, church, and community may have on decisions about self-disclosure regarding ones sexual identity, sexual risk behaviors and partnerships, use of drugs, and willingness to practice safer sex, access HIV testing services, and seek out health and medical care; and
• Identifying salient social and environmental risk factors (i.e., changes in risk vulnerabilities associated with gentrification and the relocation of neighborhoods, dislocations linked to economic conditions and unemployment rates, new drug trafficking and distribution routes, gang formation and criminal activity, and local law enforcement practices) that impact drug abuse, unsafe sex, and HIV/AIDS to inform new HIV prevention interventions to reach and engage vulnerable groups before drug use and HIV infection and STDs are endemic.

Prevention Research

Prevention efforts should target the most at-risk populations, with consideration of the role of non-injection drug use as well as injection drug use and co-morbidities (mental health, infectious disease, etc.). Many conditions associated with HIV infection suggest the need to intervene at organizational, structural, or community levels, as well as providing constructive attention to social, drug, using, and sexual networks. Studies may include:

• Development and evaluation of HIV/AIDS interventions that build community capacity for addressing risk and protective factors to reduce HIV/AIDS acquisition/transmission;
• Development and evaluation of HIV/AIDS prevention interventions for African-American and Latino MSM which address the elevated community risks for these populations, such as late diagnosis and elevated prevalence in partner populations;
• Efforts to integrate HIV/AIDS prevention and drug use prevention into settings that routinely serve adolescents and youth (including non-clinic settings) particularly MSM youth and members of ethnic/racial minorities;
• Efforts to integrate reduction of drug-use and other HIV risks into settings that routinely see persons with significant levels of substance use (e.g., STI clinics, mental health centers);
• Development and evaluation of HIV/AIDS interventions that address persistent risks such as continued sexual and drug use risk despite frequent HIV testing, or frequent episodic use of drugs in conjunction with risky sexual behavior;
• Translation of interventions with demonstrated efficacy for HIV/AIDS prevention into new settings and populations, particularly those where HIV/AIDS risk includes non-injection drug use;
• Use of effective intervention settings such as needle exchanges as hubs for interventions that more fully address HIV risk reduction;
• Development and evaluation of HIV/AIDS prevention interventions which make use of new technologies to identify recent infection, assess community-level risk for transmission, or identify co-factors for HIV transmission;
• Development and evaluation of culturally competent interventions that integrate HIV/AIDS prevention with drug use treatment or prevention in the criminal justice system; and
• Development and evaluation of HIV/AIDS prevention interventions that incorporate reduction in stigma toward persons living with HIV/AIDS and persons at elevated risk.

Health Services Research

Health services research is encouraged to improve the quality, efficiency, and effectiveness of prevention and treatment services for vulnerable populations with drug use disorders who may be infected with and/or affected by HIV/AIDS. A continuum of care and services is needed that encompasses HIV screening and counseling, and ensures that those infected receive appropriate, quality health care and other needed services. Research studies may range from the interaction of treatment or prevention services and individual-level behaviors and attributes to how financing systems, organizational structures and processes, management practices, and health technologies affect the accessibility, utilization, effectiveness, cost and quality of drug abuse and HIV/AIDS treatment and prevention services. Also of interest is research on ways stakeholders (providers, payers, school administrators, corrections officials, governmental regulators, etc.) can improve standards of care for HIV+ drug users to improve services to prevent initiation and progression from use to abuse. New study designs, measurement instruments, and data analytic methods to facilitate a new generation of health services research are needed. Studies may include but are not limited to:

• Addressing integrated universal HIV testing and counseling among high risk vulnerable drug abusing groups (e.g., racial/ethnic and gender minorities) both in and outside of the drug abuse treatment system;
• Identifying and assessing programs that provide integrated and holistic approaches to service delivery to HIV+ persons with comorbid substance abuse and/or mental health disorders (such as depression, PTSD, schizophrenia, and other disorders);
• Improving access and quality of prevention or treatment services for HIV+ drug users from vulnerable populations, including women, adolescents, racial/ethnic minorities, MSM, and those with other co-occurring disorders (such as mental health, HBV, HCV);
• Assessing the delivery of substance abuse treatment services for vulnerable populations in non-traditional settings such as schools, criminal justice facilities and primary care settings for those with HIV or at risk for HIV;
• Conducting implementation and dissemination research and developing innovative implementation models of treatment and care for vulnerable HIV+ persons within the drug abuse treatment and general health care system serving drug abusers;
• Identifying organizational characteristics (e.g., climate, culture, age, and size), financing, and managerial approaches to providing the most accessible and effective treatment for HIV, comorbid conditions, and substance use disorders among vulnerable populations;
• Examining business practice innovations intended to increase service efficiency, including workforce training and human resource management initiatives, for programs serving vulnerable populations with HIV and substance use disorders; and
• Analyzing the clinical effectiveness, cost-effectiveness, comparative effectiveness or cost-of-illness of various strategies, approaches, guidelines and protocols for the treatment of vulnerable populations with HIV and co-occurring substance use disorders.

Medical Consequences of Drug Abuse, HIV, and Co-Occurring Infections

Research is needed on the medical/clinical consequences of licit and illicit drugs of abuse, HIV, and co-occurring bacterial and viral infections such as hepatitis B, C, and D, tuberculosis (TB), sexually transmitted infections/diseases (STIs/STDs). Studies may include:

• The effects of substance abuse, HIV, and associated comorbidity on physiological or biochemical systems (e.g., cardiovascular, hepatic, respiratory-pulmonary, endocrine, immune, metabolic, oro-maxillary, and others);
• Natural history of HIV and co-occurring infectious diseases in drug abusers, disease progression and underlying pathophysiology; and role of nutrition in pathogenesis of infection;
• Impact of substance abuse on drug resistance and susceptibility to infection and mucosal integrity;
• Developing innovative non-invasive techniques/methodologies for diagnosis and assessment of drug abuse and HIV associated medical disorders/conditions;
• Developing biomarkers for the assessment of immune reconstitution, inflammatory syndrome, infectious diseases; and programmed cell death (apoptosis);
• Pharmacologic interventions for drug abuse and HIV-associated medical/clinical conditions;
• Interactions between drugs of abuse and medications used for the treatment of drug addiction (e.g., methadone, buprenorphine), HIV and co-infections (e.g., ARVs), and mental disorders (e.g., benzodiazepines); and other comorbid conditions; and
• Pharmacological, physiological, genetic, and clinical factors in progression of HIV and co-infections in vulnerable populations.

Clinical Neuroscience Research

Identifying vulnerable individuals with a higher propensity of engaging in HIV risk behavior and/or non-adherence to HIV treatment/prevention interventions is critical to HIV prevention and intervention. Translational studies are encouraged to better understand human neurocognitive and neurobiological factors that could influence disease progression and disease outcomes and could facilitate the development and/or improvement of prevention and treatment interventions in vulnerable populations. Studies may include:

• Impact of neurocognitive changes on treatment adherence and prevention in those comorbid for HIV and drug abuse;
• Characterization of biomarkers of disease progression and outcome;
• Brain correlates of risky decision processes;
• Studies of the impact of treatment non-adherence on the decline in daily living function and overall health;
• Behavioral paradigms and self-report as probes for detecting neurocognitive function;
• Vulnerability of HIV+ individuals to initiation and relapse to use of psychoactive agents including cigarette smoking;
• Consideration of emotional and motivational dysfunction and deficits in prospective memory and attention as factors in risky decision-making and as predictors of adherence to intervention/medication;
• Interactive outcomes of HIV and addictive substances effects across multiple domains of functioning; and
• Comorbidity of HIV/hepatitis virus coinfections on CNS function.

Developmental Research

Research topics include but are not limited to:

• Research on the neurobiological, neurodevelopmental, cognitive, behavioral and health sequelae of intrauterine exposure to drugs of abuse, HIV/AIDS and/or to antiretroviral therapy;
• Studies to examine the health and development of children and youth affected by HIV/AIDS and drugs of abuse. Affected children and youth include those with a caregiver or other family member with HIV/AIDS and children orphaned by AIDS;
• Research to understand the development of risk and protective factors associated with drug use and abuse and other HIV risk behaviors among vulnerable youth including youth living with and/or youth affected by HIV/AIDS, homeless youth, and young MSM;
• Research on 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 drug use and abuse on these brain and behavioral processes;
• Research on family and developmental processes which may impact risk behaviors, decision making and intervention efficacy and effectiveness of interventions;
• Interventions to ameliorate the negative behavioral and neurodevelopmental consequences for children exposed to drugs of abuse, HIV/AIDS, and/or antiretroviral therapy in utero; and
• Interventions to maintain and improve the health and development of youth living with and/or children and youth affected by HIV/AIDS and substance abuse.

Treatment and Adherence Research

Given the high rates of co-occurring substance abuse and HIV (and related risk behaviors), integrated treatment approaches that promote the prevention of HIV (and related risk behaviors) in the context of substance abuse treatment are critical. Relatedly, the intersection of substance abuse and mental health comorbidities (e.g., anxiety, depression) and stressful and adverse life events (e.g., child sexual abuse) may have profound or cumulative effects for increasing HIV risk behaviors, further highlighting the need for multi-pronged and integrated behavioral interventions. Development and improvement of behavioral interventions to promote compliance with drug abuse and HIV/AIDS treatments are essential. Finding the optimal combination of therapies to promote long term abstinence outcomes and long term adherence to AIDS medications and to promote skills to decrease sexual and other risk taking behaviors is a priority. Behavioral interventions that can foster adherence to HIV treatment regimens are needed because high rates of adherence are needed long-term to achieve and maintain viral suppression, and continued adherence to treatment regimens is clearly significant to reducing morbidity and mortality. However, substance abuse often impairs the ability and willingness of individuals to avail themselves of clinical care, including HIV testing and/or care, particularly if they are not yet HIV symptomatic. Interventions that can simultaneously reduce substance abuse and promote HIV testing and compliance with HIV care would have significant public health importance.

Examples of studies sought include but are not limited to:

• Clinical trials of integrated drug abuse treatments and HIV prevention interventions that address risky sexual behavior, risky injection practices, and overall risk reduction behaviors for adolescent and adult vulnerable populations (e.g., minorities, criminal justice populations, MSM, dually diagnosed individuals, etc.)
• Clinical trials of HIV risk reduction interventions for use during treatment, including those that target stress responses or other mental health variables likely to affect HIV risk behavior and which examine the mechanism of action of the intervention
• Studies on integrating behavioral and/or alternative and complementary approaches for HIV risk reduction with behavioral treatments or pharmacotherapies to optimize HIV risk reduction and treatment outcomes.

In general R01 projects will likely involve Stage II or III intervention research (see the Behavioral and Integrative Treatment Program Announcement for a further description of the Stage Model http://grants.nih.gov/grants/guide/pa-files/PA-06-486.html). However, Stage I projects to develop novel therapies or adherence methods may also be acceptable for the R01 mechanism when they involve substantial initial developmental cost and there is sufficient preliminary data in related or otherwise relevant domains.

Clinical Trials Network Research

The Clinical Trials Network (CTN) involves academic and treatment researchers and community-based service providers in cooperatively developing, validating, refining, and delivering new treatment options. CTN conducts rigorous, multi-site studies of behavioral and pharmacological interventions to determine efficacy and/or effectiveness across a broad range of community-based treatment settings (CTPs) and diverse patient populations. The ultimate goal is to ensure the transfer of research results to physicians, clinicians, providers, and patients. The CTN, with its core of CTPs engaging diverse populations, is also designed to provide a platform for studies which would be funded under separate research grants. Three important ways to use the CTN are: to conduct ancillary studies in connection with CTN protocols; to utilize CTN Node facilities as a platform for investigations; and for Nodes to serve as home bases for NIH Training Centers and individual researchers who have NIH fellowships or career development awards. www.nida.nih.gov/ctn/home.html

Examples of potential studies using the CTN include:

• Prevalence, incidence, treatment, or outcome studies of HIV/HCV in African American women in community drug treatment facilities. Incidence of HCV/HIV infection among African American youth in community drug treatment facilities;
• Differential rates of HIV testing among vulnerable populations;
• Risk behavior assessments and interventions in women vs. men and in African Americans vs. Caucasians and other groups;
• Outreach options for HIV prevention aimed at African American women, youth in community treatment facilities; and/or
• Conducting secondary data analyses on completed HIV Clinical Trials Network protocols www.ctndatashare.org .

Basic Neuroscience and Behavior Research

Studies may include but are not limited to:

• Studies to explore the effects of drug abuse and HIV on physiological or biochemical systems; including the CNS, PNS, cardiovascular, hepatic, respiratory-pulmonary, endocrine, and immune system as they relate to disease transmission and progression in vulnerable populations;
• Development of model systems that investigate the cognitive and behavioral differences that can lead vulnerable individuals to engage in risky behaviors associated with HIV and drug abuse;
• Comprehensive approaches to identify genetic variants in multiple ethnicities that contribute to HIV-1 vulnerability, AIDS progression, and/or susceptibility to coinfections or opportunistic infections in drug abusing individuals;
• Identification of specific genetic, epigenetic, or proteomic signatures that impact initial immune or inflammatory responses to HIV infection, HAART-induced reconstitution of immune responses, inflammation resulting from immune reconstitution, or HIV-1-induced neuroinflammation and oxidative stress in the presence of drugs of abuse;
• Studies to explore the role of epigenetics in HIV-1 infection and drug abuse; examination of changes in epigenetic host response to HIV infection through DNA methylation, chromatin modification, and/or non-coding RNAs;
• Studies that address characteristics of placental, mucosal, and blood brain barriers associated with increased vulnerability to HIV infection and progression in the presence of drugs of abuse;
• Biomarkers to assess the impact of acute and chronic stress on vulnerability to HIV infection, as well as immune function and host responses to HIV infection;
• Human or animal studies to explore the pharmacogenetic or pharmacodynamic interactions between HIV-1-related therapies and either drugs of abuse or medications for treatment of drug abuse, as well as treatments for other co-occurring conditions including infections common in drug users;
• Studies to explore gender differences in susceptibility to HIV infection and disease progression;
• Development of a model system to study various behavioral and biological aspects of HIV susceptibility and transmission in adolescents; and
• Characterize the differences that may lead to increased progression of HIV cognitive impairment or neuropathogenesis in various populations.

Special Considerations

HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse: In light of recent significant advances in rapid testing for HIV and in effective treatments for HIV, NIDA has revised its 2001 policy on HIV counseling and testing. NIDA-funded researchers are strongly encouraged to provide and/or refer research subjects to HIV risk reduction education and education about the benefits of HIV treatment, counseling and testing, referral to treatment, and other appropriate interventions to prevent acquisition and transmission of HIV. This policy applies to all NIDA funded research conducted domestically or internationally. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-07-013.html.

National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects: The National Advisory Council on Drug Abuse (NACDA) recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects. 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 Web site at http://www.nida.nih.gov/about/organization/nacda/CouncilStatement.html.

Networking Website for Consultation and Collaboration

NIDA has established a web-based Networking Project (NNP) to encourage investigators to collaborate with other scientists to gain access to specialized expertise, unique research resources, diverse populations, or geographic locations not otherwise available. For applicants interested in identifying potential collaborators, the NNP website is available at http://nnp.drugabuse.gov, as a source of information on the mission, focus, and leadership of NIDAs research networks. The website features an interactive map with more than 300 local network sites, a directory of close to 400 addiction researchers and practitioners, and the extensive resources of 14 NIDA-supported research networks located across the country. If appropriate for the proposed research, NIDA encourages grant applicants to use the resources of the NNP and make reference in the grant application when they are utilized.

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 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 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 IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

The total project period for an application submitted in response to this funding opportunity may not exceed 5 years. Applicants for an R01 award are not limited in dollars but need to reflect the actual needs of the proposed project.

Facilities and Administrative (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

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education
• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Small Businesses
• For-Profit Organizations (Other than Small Businesses)
• State Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribally Designated Organizations
• County Governments
• City or Township Governments
• Special District Governments
• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• U.S. Territory or Possession
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Regional Organizations
• Other(s):
  • Eligible Agencies of the Federal Government
  • Faith-based or Community-based Organizations.

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 (i.e., multiple PDs/PIs), may be designated on the application for projects that require a team science approach and therefore clearly do 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 electronic Research Administration (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 grant with a single PD/PI or multiple PDs/PIs grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit more than one application, provided that 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). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications will be permitted only a single amendment (A1). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Original new and competing renewal applications that were submitted prior to January 25, 2009 will be permitted two amendments (A1 and A2). For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.

Renewals. Renewal applications may be submitted in response to this FOA.

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, use the Apply for Grant Electronically button in this FOA or 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:

• 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 NIH eRA Commons.

Several additional separate actions are required before an applicant 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 be registered also in the NIH eRA Commons. In the case of multiple PDs/PIs, all PDs/PIs must be registered and be assigned the PI role 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 his/her designee who is already registered in the Commons.

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

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. Some fields within the SF424 (R&R) application components, 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/PIs 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.)

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

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 13 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 plan approach for the proposed 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, must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

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

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 3.4 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: (Earliest date an application may be submitted to Grants.gov) August 7, 2009
Application Due Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due 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 due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due 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 weekdays (Monday Friday, excluding Federal holidays) to view the application image to determine if any further action is necessary.

• If everything is acceptable, no further action is necessary. The application will automatically move forward to the Division of Receipt and Referral in the Center for Scientific Review for processing after two weekdays, excluding Federal holidays.
• 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 it is determined that some part of the application was lost or did not transfer correctly during the submission process, the AOR/SO will have the option to Reject the application and submit a Changed/Corrected application. In these cases, please contact the eRA Help Desk to ensure that the issues are addressed and corrected. Once rejected, applicants should follow the instructions for correcting errors in Section 2.12, including the requirement for cover letters on late applications. The Reject feature should also be used if you determine that warnings are applicable to your application and need to be addressed now. Remember, warnings do not stop further application processing. If an application submission results in warnings (but no errors), it will automatically move forward after two weekdays if no action is taken. Some warnings may need to be addressed later in the process.
• 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 didnt 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/SO receives the Grants.gov acknowledgments. The AOR/SO 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 critique from the previous review.

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 renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or 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 NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements.

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

The NIH requires the PD(s)/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

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts.

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 plans are being developed for the study;

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

3) Include a cover letter with the application that identifies 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. An application that does not comply with the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value 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

1. Criteria

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 on the basis of established PHS referral guidelines to the ICs for funding consideration.

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 scientific peer review, all applications will:

• Undergo a selection process in which only those applications deemed to have the highest scientific and technical merit, generally the top half of applications under review, will be discussed and assigned an impact/priority score;
• Receive a written critique; and
• 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 and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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

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

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

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

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

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

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) Protections for Human Subjects, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria

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

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

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

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

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

Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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

Additional Review Considerations

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

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

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

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

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

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the 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 Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

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

Section VII. Agency Contacts

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

1. Scientific/Research Contact(s):

National Institute on Drug Abuse:

Albert Avila, Ph.D.
Division of Basic Neuroscience and Behavioral Research
National Institute on Drug Abuse
Neuroscience Center, Room 4279
6001 Executive Boulevard
Bethesda, MD 20892-9555
Telephone: (301) 496-8804
Fax: (301) 594-6043
Email: [email protected]

Richard A. Jenkins, Ph.D.
Prevention Research Branch
Division of Epidemiology, Services & Prevention Research
National Institute on Drug Abuse
6001 Executive Blvd.
Rm. 5185 MSC 9589
Bethesda, MD 20892-9589
Telephone: (301) 443-1923
Fax (301) 480-2542
E-mail: [email protected]

Will Aklin, Ph.D.
Behavioral and Integrative Treatment Branch
Division of Clinical Neuroscience and Behavioral Research
National Institute on Drug Abuse
6001 Executive Blvd., Rm. 3150, MSC 9593
Bethesda, MD 20892-9593
Phone: (301) 443-3207
Fax: (301) 443-6814
E-mail: [email protected]

Jag H. Khalsa, Ph.D.
Medical Consequences Branch
Division of Pharmacotherapies and Medical
Consequences of Drug Abuse (DPMC)
National Institute on Drug Abuse, NIH
6001 Executive Blvd., Room 4137, MSC 9551
Bethesda, MD 20892-9551
Telephone: (301) 443-2159
Fax: (301) 443-2599
E-mail: [email protected]

Elizabeth Lambert, M.Sc.
Epidemiology Research Branch
Division of Epidemiology, Services, and Prevention Research
National Institute on Drug Abuse
6001 Executive Blvd.
Room 5147, MSC9589
Bethesda, MD 20892-9589
301-402-1933
301-443-2636 (FAX)
E-mail: [email protected]

National Institute of Nursing Research:

Jeanette M. Hosseini, Ph.D.
Program Director, Office of Extramural Programs
National Institute of Nursing Research, NIH
6701 Democracy Blvd., Suite 710
Bethesda, MD 20892-4870
Telephone: 301-594-5972
Fax: 301-480-8260
Email : [email protected]

2. Peer Review Contact(s):

Not Applicable

3. Financial/Grants Management Contact(s):

National Institute on Drug Abuse:

Pam Fleming
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Blvd., MSC 9541
Rockville, MD 20892-9541
Telephone: 301-435-1369
Fax: 301-594-6849
Email: [email protected]

National Institute of Nursing Research:

Kelly Oster
Grants Management Specialist
National Institute of Nursing Research
6701 Democracy Blvd., Suite 710
Bethesda, MD 20892-4870
Telephone: (301) 594-2177
Fax: (301) 451-5651
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

Vertebrate Animals:
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 impact/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, Minorities, and Children:
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-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicines 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. 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/.