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 Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov)

Title:  International Research on Venue-Based Interventions for HIV/AIDS and Alcohol Use (R01)

Announcement Type
New

Request For Applications (RFA) Number: RFA–AA-08-011

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

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

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

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

Catalog of Federal Domestic Assistance Number(s)
93.273

Key Dates
Release/Posted Date:  February 26, 2008
Opening Date:  April 9, 2008 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): April 9, 2008
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). 
Application Submission/Receipt Date(s):  May 9, 2008
Peer Review Date(s): June/July 2008 
Council Review Date(s): August 2008
Earliest Anticipated Start Date(s): September 1, 2008
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: May 10, 2008

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism 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 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

The intent of this FOA issued by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) is to stimulate research, particularly collaborative efforts between US and foreign investigators, to investigate alcohol-related aspects of risks for HIV transmission and infection. The primary focus of this announcement is to develop and test new interventions, which may also include exploratory descriptive studies that lead to the development of venue-based interventions.  There is considerable epidemiological evidence linking alcohol-related high risk sexual behavior with HIV and other sexually transmitted infections. Ethnographic research has provided rich descriptions of social, cultural, and economic contexts in which people engage in alcohol-related sexual risk behaviors.  More specifically, alcohol use characteristics (e.g., binge drinking, episodic drinking, etc.) have been linked with sexual risk-taking that occurs in a range of high risk environments. Recent reviews of the epidemiological literature from studies done in Africa have shown that heavy alcohol users were more likely to be HIV+. Problem drinkers were twice as likely to be HIV+ when compared with non-problem drinkers. Yet few interventions explicitly address the contribution of alcohol use to co-occurring high risk sexual or drug use behavior.  Instead, alcohol consumption often is subsumed under the category of a generic “trigger” for behavioral risk, while limited attention is given to the unique contextual or motivational aspects of alcohol use which may influence sexual and drug use HIV risk behavior. 

This FOA seeks to explore alternative strategies for developing and testing interventions that are ecologically sound and address the role of alcohol in increasing HIV risk behaviors in geographically identified contexts. Alcohol use settings and aggregate risks found within these settings have been implicated as a focus for converging social, substance abuse, and sexual networks. There is a need for further research to further extend the understanding of environmental facilitators of risk for HIV infection within these settings and locations, which are often in urban areas which draw men and women for employment.  Populations engaging in high risk sexual behaviors consequent to alcohol use, particularly heavy episodic or binge drinking, can include, but are not limited to, male bar patrons and their sex partners; male and female commercial sex workers and clients; transport corridor workers (e.g., long distance truck drivers, merchant marines, etc.); fishermen; and employed military personnel, among others.

Recent reviews of the literature from research conducted in Africa, Russia and India have described the strong relationship between alcohol use, sexual risk taking, and the risk for HIV infection, focusing on behaviors such as having multiple, concurrent sex partners and having unprotected sex.  In wine shop settings in India it was observed that over 50% of patrons reported 3 or more partners in the last 3 months and 71% reported a history of exchanging sex for money and low rates of condom use. In addition, the lowest use of condoms was among those who reported drinking to feel disinhibited and those having expectancies that alcohol use would enhance sexual activity. These findings and other similar findings suggest that certain specific settings may be appropriate targets for interventions which incorporate knowledge of alcohol use effects within these contexts. Interventions targeting the unique contextual cues that impel or inhibit drinking and unsafe sex may be of particular interest.

Settings

Locations where high risk sexual behaviors are initiated (high risk venues) include formal and informal drinking establishments in both urban and rural areas.  They often exist along frequently traveled routes or near borders where populations mix.  These locations may include bars, “shabeens” (home-brew or unlicensed sales points); migrant worker settlements; commercial sex establishments such as brothels or massage parlors; circuit parties; bathhouses (the latter two venues are increasingly common in SE Asia and are contributing to the growing epidemic among MSM there); truck stops; bus terminals or ports; border towns; and high risk work settings, in particular those which involve alcohol production (e.g., shabeens).  Bars and other drinking venues where alcohol is consumed and sexual mixing occurs are ideal settings in which to implement HIV prevention programs. Such programs may deliver a range of evidence-based, low-cost, feasible, public health interventions that can reach persons and social networks engaged in high risk sexual behaviors.

Other formal or informal health care venues (e.g., STI clinics and substance abuse treatment programs, emergency rooms, and indigenous health care provider practice settings, etc.) may also provide critical opportunities to identify individuals who engage in both at-risk drinking and high risk sexual and drug use behaviors. These individuals may be highly receptive to advice regarding alcohol use and sexual risk behavior during “teachable moments” (e.g., advice regarding ways to reduce risk of re-infection with sexually transmitted pathogens, including reducing visits to high risk venues such as circuit parties, etc.).

Additional Issues: Limitations of Past Interventions

In the past randomized controlled trials based on Information Motivational Behavioral (IMB) models have dominated community-based interventions targeting individuals who engage in HIV risk behaviors, and, to a lesser extent, those with alcohol use disorders. These rational cognitively-focused models have also dominated addiction treatment in clinical contexts. However, recent research on these interventions has defined the limits of these intense client-centered approaches to changing behavior, often finding only a modest treatment effect.  While Motivational Interviewing, Cognitive Behavioral Therapy, Behavioral Couples’ Therapy, and Twelve Step-oriented treatments have been applied in both HIV and alcohol abuse areas, reviews of the research on these interventions have suggested that more impelling situational cues, particularly in the context of substance use, and situational control factors often undermine intended long-term behavior change and prevention practices.  These factors may be particularly important determinants of the level of negotiated risk among women, since women are often unable to control male condom use.   This solicitation strongly encourages research on novel interventions that incorporate knowledge of venue-specific factors that may influence sex and drug-related decision-making in the targeted population.

A specific focus of this research should be on how specific environmental contexts (bars, etc.) affect intervention targets such as cognitions or implementation of behavior skills.  Creative use of a wide range of research methodologies is encouraged, including combining qualitative and quantitative methods.  In addition, investigators are encouraged to consider how theories of behavior change can be applied to the unique contexts described above.  A number of setting-specific strategies to promote behavior change that reduces the risk of HIV infection among individuals with alcohol use disorders have been suggested. These contextualized interventions broadly distributed in the environment may prove to be a more comprehensive and effective approach that begins to acknowledge the important impact that specific venues may have on high risk sexual and alcohol use behavior.

It is important to note that prior research has demonstrated the limited effectiveness of modest modifications of interventions for a single behavior to address co-occurring drinking and unsafe sex.  It seems likely, therefore, that modest adaptations of existing interventions will have only a limited public health impact.  Exploratory efforts are needed to understand the specific contextual cues and sequence of causal pathways that link alcohol use to HIV risk behavior, as well as to identify which of those pathways can be effectively changed using innovative counseling techniques or other interventions.  Accordingly, one purpose of the R21 is to provide investigators with an opportunity to conduct theory-driven formative research that moves beyond technical modifications of existing strategies to fully developed, novel interventions.

New Approaches to Developing and Testing Interventions

Different community- and individual-level approaches to developing interventions for people with alcohol use disorders have at times acknowledged the importance of physical or venue-based interventions, but have not in general incorporated more comprehensive, integrated or multilevel strategies (e.g.,  an approach that simultaneously targets individual bar patrons, alcohol servers, and alcohol policy-makers, etc.).  It is important that addiction and HIV researchers explore new ways to examine and impact the full range of settings where substances, in particular alcohol, may influence HIV transmission, particularly in international settings where intensive psychotherapy and other individual-level approaches are not feasible or are unlikely to be effective.

Venue-based research draws on the increased ability to map the larger physical environment, social networks, and HIV-risk behaviors of individuals who engage in problem drinking within these environments.  Developing complete community-level maps of risk and potential intervention venues such as bars and night clubs could lead to an “ecological understanding” of risk and how it is distributed in time and space. It may thus both increase the ability to predict the rate of spread of HIV and suggest critical intervention points in this larger context.

The use of the R01 Research Project mechanism will provided  an opportunity for investigators to develop new collaborations or build upon existing collaborations to conduct innovative studies addressing any of a number of research questions.  (See below.) It is anticipated that the data collected and knowledge gained will lay the foundation for the development of future regional research networks.

Areas of Interest

The purpose of this NIH research program is to increase research on alcohol-related HIV risk that will inform interventions to reduce sexual risk-taking among patrons of formal or informal drinking establishments and among patients in a variety of alcohol treatment settings, including but not limited to emergency rooms and alcohol treatment programs.   It is ultimately intended to provide the scientific foundation upon which governments may build effective and far-reaching HIV prevention programs that will stem the tide of the epidemic. The program expands and enhances past NIAAA activities in the area of alcohol and HIV/AIDS prevention and other related areas, including research on server training, safe rides programs, brief interventions in a variety of contexts, and social/structural interventions shown to be effective in reducing alcohol-related morbidity and mortality.

In addition, NIAAA recognizes that there are ongoing alcohol and HIV/AIDS interventions that may benefit from increased research capacity. The proposed research-tested interventions will be designed to strengthen the capacity of public health agencies, non-government (NGO), and community-based (CBO) organizations to: 1) engage bar owners, operators of informal drinking establishments, and other personnel associated with drinking venues, who will be instrumental in providing access and a supportive environment in which to carry out interventions; and 2) develop and implement venue-based, appropriately tailored public health interventions targeting specific populations or sub-populations at increased risk of HIV infection because of their drinking and sexual risk behaviors; and 3) measure structural, behavioral, and biological outcomes (e.g., adoption of programs, norm changes, and HIV/STD incidence).

Potential Partners

NIAAA recognizes that there may be special opportunities in different regions of the world to address particular questions of interest.  The questions below are examples of universal and region-specific research questions that are of interest. The inclusion of region-specific areas of interest is meant to encourage research that has the potential to ultimately lead to regional research networks that address HIV/AIDS. 

Venue-based interventions may be carried out in collaboration with existing intervention sites such as those supported by the Centers for Disease Control and the Office of the Global AIDS Coordinator – President’s Emergency Plan for AIDS Relief (OGAC-PEPFAR).  Such programs may already include interventions based on delivery of informational materials; outreach and delivery of risk reduction messages to patrons; scheduled “events” such as skills-based training (e.g. condom use); condom distribution; on-site HIV counseling and testing; referral to HIV/AIDS care and treatment services; STI testing for commercial sex workers; services targeting pregnant women for the prevention of mother to child transmission; and peer-educator interventions. However, adequate research measurement to assess a variety of outcomes and to assure fidelity of approach and quality of the data must be included.

Specific outcomes of interest include but are not limited to:

1.         Increased knowledge and awareness of the strong relationship between alcohol use, sexual risk taking, and the risk for HIV infection among patrons, owners, managers, and other persons who frequent alcohol establishments.  Identification of effective approaches to reducing high risk sexual behaviors associated with these venues.

2.      Increased knowledge and awareness of the strong relationship between alcohol use, sexual risk taking, and the risk for HIV infection in medical and other clinical settings, including but not limited to STI clinics, emergency rooms, and other formal and informal health care delivery settings.  Identification of effective approaches to delivering alcohol and HIV/AIDS interventions in these settings.

3.      Increased knowledge and awareness of the strong relationship between alcohol use, sexual risk taking, and the risk for HIV infection in other high risk community settings (e.g., truck stops, brothels, bathhouses, etc.), including development of measures that address use of alcohol in partner selection and involvement in high risk sexual behavior.  Identification of effective approaches to reducing high risk sexual behaviors associated with these settings.

4.      Determination of best approaches to using rapid HIV testing methodology supported by the CDC to determine HIV status, or other appropriate biological outcomes where possible, and to carrying out cross-sectional sampling of  regional populations.  Determine feasibility of HIV testing among alcohol users and their partners in identified settings like bars, bathhouses, and circuit parties. (There already have been efforts in Asia to do testing in circuit party settings, and bathhouse-based testing is very common in the US.)

5.      Development of new measurement methodologies, including adequate tests of intervention “stopping points” at which sufficient data has been collected to support modifying or discontinuing strategic interventions. Measurement of implementation impact. Examples of innovative methodologies might include but not be limited to small sample designs that would enable detailed exploration of intervention uptake and outcome under different scenarios of dosage, modality, etc. Another example would be the development of new approaches to measuring alcohol use and HIV risk behavior in situ or at other points where recall will be most reliable. This will be more practical in countries where new alcohol use indicators (transdermal patch) are widely available and easily adopted. Simpler methods like counting patrons, collecting beer bottles, and collecting used condoms in a brothel setting could be done in reduced resource settings.

6.      Development of new theoretical and modeling approaches that are based on person x environment interactions, including models that map physical, social, and temporal dimensions of risks distributed within the environment as a result of alcohol use (e.g., liquor outlets). This modeling may be approached in several different ways; e.g., the modeling could be non-quantitative and based more on obtaining scripts or ethnographic observations of settings; or it could be based on asset (social capital) mapping or mapping daily routes and activities of individuals to form comprehensive risk profiles (e.g., mapping as part of a rapid policy assessment after implementation of a structural intervention, etc.).

7.      We encourage applications that are adjuncts to existing trials to address measurement and assessment issues, as well as novel evaluation methods. The goal is to promote descriptive research that may inform the development of effective interventions.

Global/Universal Questions:

•        How can alcohol risk reduction interventions better address situations where alcohol use contributes to HIV sexual risk behavior among HIV+ individuals?  How can alcohol treatment and outreach programs be adapted and improved to reduce alcohol-related high risk sexual behaviors?

•        How can interventions to identify alcohol use disorders or reduce problem drinking be integrated into STD clinic environments?

•        How can practitioners in settings that see problem drinkers (e.g., primary care clinics, STD clinics, etc.) be trained to provide alcohol assessment, referral for treatment, and brief interventions to reduce alcohol consumption?

•        How can interventions for problem drinking be effectively implemented in settings where alcohol is served or consumed and where people seek sexual partners? The business practices and potential roles of staff in these establishments (e.g., bartenders, sex workers, etc.) should be considered.

•        How can media-based interventions to reduce alcohol-related HIV risk behaviors be implemented in settings where alcohol is served or consumed and where people seek sexual partners, including small media, interactive video, role model stories delivered by various media, etc.?

•        What measurement methodologies and paradigms from the study of environments can be applied to HIV prevention in alcohol-related venues (e.g., behavior setting measurement, rapid ethnographic assessment, etc.) and used for outcome and process evaluation in intervention studies?

•        How can behavioral assessment methodologies (e.g., diary methods, applied behavior analysis, etc.) be adapted for evaluation of HIV risk and alcohol use in interventions conducted in alcohol-related venues?

•        How can HIV testing/counseling/prevention/referral for care take advantage of the unique features of alcohol treatment settings, including both inpatient and outpatient settings?

•        How can HIV testing and counseling be promoted in settings where alcohol use and HIV sexual risk behavior are common, such as bathhouses and circuit parties?

•        How may we better understand the intersection between alcohol use and abuse and commercial and transactional sex?  “Transactional sex” refers to less overtly commercial transactions where exchanges of money, goods, and services for sex occurs. How may enhanced information about the role of alcohol in commercial and transactional sex be used to develop effective HIV preventive interventions?

•        How can messages about individual survival and the effects of viral resistance factors on disease progression, complications (such as liver damage), and response to antiretroviral treatment be framed in the context of alcohol abuse/HIV risk reduction efforts in clinical and high risk community settings (e.g., studies examining approaches to integrating such messages into alcohol treatment programs or HIV treatment and service settings, etc.)?

•        How can messages about alcohol use disorders and comorbid psychiatric illnesses be framed to improve clinical management of HIV/AIDS and co-morbid psychiatric conditions such as depression in the setting of continued alcohol use and abuse.  How can such messages be integrated into risk reduction strategies in mental health or substance use case management, HIV treatment settings, and AIDS service organizations?

•        What interventions for alcohol misuse and alcohol use disorders (including both behavioral and pharmacological interventions) can be effectively employed in international settings to reduce HIV acquisition and transmission among chronic and acute alcohol users?

•        What interventions to reduce HIV acquisition and transmission (e.g., testing and counseling, structural, outreach, etc.) can be effectively employed in international settings to reduce HIV transmission among chronic and acute alcohol users, especially given that these individuals often have poor access to VCT and treatment and/or fail medication regimens prematurely?

•        What is the cost-effectiveness of interventions that may be implemented in alcohol-related venues to reduce HIV/AIDS morbidity and mortality?

•        What are the best approaches to integrating HAART and interventions for problem drinking in specific venues?

•        How do policies established by commercial sex establishment owners or regulatory bodies involved with alcohol affect alcohol consumption, HIV risk behavior, and the ways in which alcohol is used in conjunction with sexual risk behavior?

•        How can HIV-related services, including strategies to improve adherence to HAART, be adapted to address the needs of drinkers in specific alcohol-related venues (e.g., bars, etc.)?

•        How can effective HIV prevention interventions be developed for sex workers who engage in at-risk drinking?

•        How does culture influence the interaction between alcohol and HIV risk behavior in specific venues?

•        How can prevention and treatment interventions for problem drinking be integrated with established venue-based HIV prevention approaches to optimize their combined effectiveness? What institutional changes would need to take place to allow for this integration?

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

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

2. Funds Available

The participating organization, NIAAA, intends to commit approximately 3 million dollars in FY2008 to fund 10-12 applications. It is anticipated that interventions will be identified within 5 to 7 different countries. These activities may be coordinated by NIAAA through a variety of cooperative mechanisms in order to assure comparable outcome measures for interventions. Costs may include: (1) development of specific intervention materials; (2) travel and consultation fees for experts conducting research and follow-up measurement; (3) participant travel to study sites; (4) program support to add the intervention component to existing programs; and (5) translation, monitoring, and evaluation of outcome measures.

Budget: The total projected 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. U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit detailed budget requests using the Research & Related Budget component found in the application package.

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

NIH grants policies as described in the NOT-OD-05-004, November 2, 2004.  

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

1.B. Eligible Individuals

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

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

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

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

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

Renewal applications are not permitted in response to this FOA.

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

Section IV. Application and Submission Information


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:

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

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 support@grants.gov     

2) Organizational/Institutional Registration in the eRA Commons

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 commons@od.nih.gov

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

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

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

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

1. Request Application Information

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

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

For further assistance, contact GrantsInfo: Telephone 301-435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

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

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

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist 
PHS398 Modular Budget or Research & Related Budget, 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

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

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

Applications from foreign organizations must:

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

The intent of this FOA is to encourage collaborative research proposals.  Consequently, investigators are encouraged to submit applications with Multiple PDs/PIs.

SPECIAL INSTRUCTIONS  

Applications with Multiple PDs/PIs

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

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

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

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

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

Applications Involving a Single Institution

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

Applications Involving Multiple Institutions 

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

When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 5.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date:  April 9, 2008 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): April 9, 2008
Application Submission/Receipt Date(s): May 9, 2008
Peer Review Date(s): June/July 2008
Council Review Date(s): August,2008
Earliest Anticipated Start Date(s): September 1, 2008

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Abraham Bautista, Ph.D.
Chief, Extramural Project Review Branch
Office of Extramural Activities
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3039
Bethesda, MD 20892-9304
Telephone: 301-443-9737
Fax:   301-443-6077
Email:  bautista@mail.nih.gov

3.B. Submitting an Application Electronically to the NIH

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

In order to expedite the review, applicants are requested to notify the NIAAA Referral Office by email at bautista@mail.nih.gov when the application has been submitted.  Please include the FOA number and title, PD/PI name, and title of the application.

3.C. Application Processing

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

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

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

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons. 

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

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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

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

6. Other Submission Requirements

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

The NIH requires the PD/PI to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Registration FAQs – Important Tips -- Electronic Submission of Grant Applications.”

Organizational DUNS

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

PHS398 Research Plan Component Sections

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

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

Appendix Materials

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

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

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/.

Foreign Applications (Non-Domestic [non-U.S.] Entities)

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

Section V. Application Review Information


1. Criteria 

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

2. Review and Selection Process

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

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

Applications submitted in response to this FOA will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:

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, and weighted as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

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

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs?

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

Investigators: Are the PD(s)/PI(s) and other key personnel 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? Do(es) the PD(s)/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment:  Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, 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 “Human Subjects Sections” of the PHS398 Research Plan component of the SF424 (R&R).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See the “Human Subjects Sections” of the PHS398 Research Plan component of the SF424 (R&R)
 
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the adequacy of the plans for their care and use will be assessed. See the “Other Research Plan Sections” of the PHS398 Research Plan component of the SF424 (R&R). 

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

2.B. Additional Review Considerations

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

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

2.C. Resource Sharing Plan(s)

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

3. Anticipated Announcement and Award Dates

Not Applicable.

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his/her Summary Statement (written critique) via the NIH eRA Commons

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.

3. Reporting

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

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

Section VII. Agency Contacts


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

1. Scientific/Research Contacts:

Kendall Bryant, PhD
Coordinator, HIV/AIDS Research
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health
5635 Fishers Lane
Rockville MD 20892-9304
Phone 301-402-9389
Fax   301-443-8614
email  kbryant@mail.nih.gov

2. Peer Review Contacts:

Abraham Bautista, Ph.D.
Chief, Extramural Project Review Branch
Office of Extramural Activities
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3039
Bethesda, MD 20892-9304
Telephone:   301-443-9737
Fax:   301-443-6077
Email:  bautista@mail.nih.gov

3. Financial or Grants Management Contacts:

Judy Fox, Chief
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism 
5635 Fishers Lane, Room 3023
Bethesda, MD 20892-9304
Telephone: (301) 443-4704
Fax: (301) 443-3891  
Email:   jfox@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

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

Human Subjects Protection:
Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

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

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

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

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

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

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

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

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

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

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

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

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

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

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

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

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

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


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NIH Funding Opportunities and Notices


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