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 Mental Health (NIMH), (http://www.nimh.nih.gov)

Title: Non-injection Drug Abuse and HIV/AIDS (R01)

Announcement Type
New

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

Looking Ahead: As part of the Department of Health and Human Services' implementation of e-Government, during FY 2006 the NIH will gradually transition each grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications electronically using Grants.gov.. For more information and an initial timeline, see http://era.nih.gov/ElectronicReceipt/. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html). Specific funding opportunity announcements will also clearly indicate if Grants.gov submission and the use of the SF424 (R&R) is required. Investigators should consult the NIH Forms and Applications Web site (http://grants.nih.gov/grants/forms.htm) for the most current information when preparing a grant application.

Program Announcement (PA) Number: PAS-06-054

Catalog of Federal Domestic Assistance Number(s)
93.279, 93.242

Key Dates
Release Date: November 2, 2005
Letter of Intent Receipt Date(s):  Not applicable
Application Submission Dates(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
AIDS Application Receipt Dates(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm#AIDS for guidance on dates
Peer Review Date(s): see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for guidance on dates.
Council Review Date(s): see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for guidance on dates.
Earliest Anticipated Start Date: see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for guidance on dates.
Additional Information To Be Available Date (Url Activation Date): Not applicable.
Expiration Date for R01 Non-AIDS Applications: November 2, 2006
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
  1. Research Objectives

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

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

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

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

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Purpose

This PA seeks to understand the contribution of non-injection drug abuse to the acquisition and/or transmission and/or disease progression of HIV/AIDS.  Specifically, it seeks to: 1) investigate how, where, why, and among whom HIV/AIDS spreads through high-risk sexual behavior associated with non-injection drug use; 2) develop effective prevention interventions and treatment for non-injection drug users at risk for or infected with HIV; and 3) improve accessibility and utilization of evidence-based, integrated care for non-injection drug abuse, risky sexual behavior, and HIV/AIDS and other infectious diseases.  The PA will support research employing a range of methodological approaches including basic, clinical, epidemiological, prevention, and treatment studies as well as multidisciplinary research in the biomedical, behavioral, and social sciences to contribute to knowledge in these areas.

Background and Significance

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

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

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

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

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

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

Research Scope

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

Basic and Clinical Research

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

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

Research on HIV and Development

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

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

Epidemiological Research

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

Prevention Research

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

Health Services Research

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

Medical Consequences of Drug Abuse and Co-Occurring Infections

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

Behavioral Treatment Research

The following Stage I, II, and III Behavioral Treatment Research areas of interest can be viewed within the context of Program Announcement PA-03-126, at http://grants.nih.gov/grants/guide/pa-files/PA-03-126.html.:

Stage I Behavioral Treatment Research:

Stage II Behavioral Treatment Research:

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

Section II. Award Information

1. Mechanism(s) of Support

National Institutes of Health (NIH) research project (R01) award mechanism. The total project years for an application submitted in response to this PA may not exceed five years for the R01. Information on the Research Project Grant (R01) mechanism is available at: http://grants.nih.gov/grants/funding/r01.htm.

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

This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format described in the PHS 398 application instructions. Otherwise follow the instructions for non-modular research grant applications.

2. Funds Available

To support this initiative, in each of fiscal years 2006, 2007, and 2008, NIDA has set aside $3,000,000 total costs to support applications of high scientific merit that are responsive to this PA and that do not get selected for payment with regular research project grant funds.   The amount and timing of awards paid from set aside funds will depend on the overall scientific merit of the applications and the availability of funds throughout the duration of this solicitation (3 years).  Although the financial plan of the IC provides support for this program, awards pursuant to this PAS are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications  While NIMH is participating in this Program Announcement, NIMH has not set funds aside specifically for this program.

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

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

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

1.B. Eligible Individuals

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

2. Cost Sharing or Matching

Cost sharing is not required.

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

3. Other-Special Eligibility Criteria
Not applicable

Section IV. Application and Submission Information

1. Address to Request Application Information

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

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

2. Content and Form of Application Submission

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

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

Charge back of customs and import fees is not allowed.

Format: every effort should be made to comply with the format specifications, which are based upon a standard US paper size of 8.5" x 11."

Funds for up to 8% administrative costs (excluding equipment) can now be requested (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html)

Organizations must comply with federal/NIH policies on human subjects, animals, and biohazards.

Organizations must comply with federal/NIH biosafety and biosecurity regulations. See Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

Proposed research should provide a unique research opportunity not available in the U.S.

3. Submission Dates and Times
See Section IV.3.A for details.

3.A. Submission, Review and Anticipated Start Dates

Letter of Intent Receipt Date(s): Not applicable
Application Submission Dates(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
AIDS Application Receipt Dates(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm#AIDS for guidance on dates
Peer Review Date(s): see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for guidance on dates.
Council Review Date(s):  see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for guidance on dates.
Earliest Anticipated Start Date: see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for guidance on dates.

3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.

3.B. Sending an Application to the NIH

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

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

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

3.C. Application Processing

Applications must be submitted on or before the application receipt/submission dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.

Upon receipt applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

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

6. Other Submission Requirements

Specific Instructions for Modular Grant applications

Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

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 must carry out the following steps:

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

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

3) Include 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 investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.

Plan for Sharing Research Data

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

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

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

Sharing Research Resources

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

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

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 to the ICs on the basis of established PHS referral guidelines.

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

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

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

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

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

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

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

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

2.A. Additional Review Criteria:

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

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

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

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

2.B. Additional Review Considerations

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

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

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

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

3. Anticipated Announcement and Award Dates
Not applicable

Section VI. Award Administration Information

1. Award Notices

 If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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

2. Administrative and National Policy Requirements

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

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

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

1. Scientific/Research Contacts:

NIDA Contact

Lynda Erinoff, Ph.D.
AIDS Research
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Blvd.
Room 5274 MSC 9581
Bethesda, MD 20892-9581
Telephone: (301) 402-1972
FAX: (301) 443-9127
Email:
le30q@nih.gov

NIMH Contact   

Andrew D. Forsyth, Ph.D.
Chief, Primary HIV Prevention & Behavior Change Program
Center for Mental Health Research on AIDS
National Institute of Mental Health
6001 Executive Boulevard, RM 6201, MSC 9619
Bethesda, MD USA 20892-9619
Telephone: 301/443-8403
FAX: 301/443-9719
E-mail: aforsyth@mail.nih.gov

2. Peer Review Contacts:
Not applicable

3. Financial or Grants Management Contacts:

NIDA Contact

Gary Fleming, J.D.
Chief, Grants Management Branch/OPRM
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Room 270
Bethesda, MD 20892
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: gfleming@nida.nih.gov

NIMH Contact

Rita V. Sisco
Supervisory Grants Management Specialist
National Institute of Mental Health/NIH/DHHS
6001 Executive Blvd., Room 6120
Rockville, MD 20892
Tel: (301) 443-2805
Fax: (301) 443-6885
Email: rr46w@nih.gov

Section VIII. Other Information

Required Federal Citations

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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

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

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

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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