Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
V.A. Office of Research and Development (http://www.research.va.gov/)

Components of Participating Organizations
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov)
National Institute on Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov)
National Cancer Institute (NCI), (http://www.cancer.gov)

Title: Substance Use and Abuse among U.S. Military Personnel, Veterans and their Families (R01)

Announcement Type
New

Request for Applications (RFA) Number: RFA-DA-10-001

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

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

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

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.279, 93.273, 93.399

Key Dates
Release/Posted Date: July 29, 2009
Opening Date:  November 22, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s):  November 23, 2009
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). 
Application Due Date(s):  December 22, 2009
Peer Review Date(s): February/March 2010 
Council Review Date(s): May 2010
Earliest Anticipated Start Date(s): July 2010 
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: December 23, 2009

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. Receipt, Review, and Anticipated Start Dates
          1. Letter of Intent
    B. Submitting an Application Electronically to the NIH
    C. Application Processing   
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices

2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contacts
1. Scientific/Research Contact(s)

2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

This Funding Opportunity Announcement (FOA) seeks research applications focused on the epidemiology/etiology, screening and identification, prevention and treatment of substance use and abuse (including alcohol, tobacco and illicit and prescription  drugs) and associated problems (e.g., post-traumatic stress disorder (PTSD), traumatic brain injury (TBI), depression, anxiety, sleep disturbances, chronic pain, interpersonal violence) among  U.S. military personnel, Veterans and their families.  This RFA is specific to research related to individuals who are serving or have served in Operation Enduring Freedom (Afghanistan) and/or Operation Iraqi Freedom (Iraq) (OEF/OIF).  In addition, research related to all phases of the deployment cycle, (i.e., pre-deployment, deployment, re-integration, and separation) and all branches of the military (e.g., Army, Navy, Marines, Air Force, Coast Guard, U.S. Military Reserves, National Guard) and Veterans are of interest.  National Guard and Reserve service members, Individual Augmentees and Families have been identified as special needs populations that are of particular interest due to limitations in support related to not being attached to a military installation, among other factors.   An Individual Augmentee is a United States military member assigned to a unit for the purpose of filling in for, or augmenting, members of that unit.

Although not participating in this FOA, the National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/) shares an interest in some areas of research described in this FOA.  These interests are reflected in recent FOAs focused on the Study of Suicidality and Mental Health in the U.S. Army, the Mental Health Needs of Returning Combat Veterans in the Community, Prevention of Trauma Related Adjustment and Mental Disorders in High-Risk Occupations, Developing PTSD Risk Assessment Tools, Clinical Pharmacotherapy for PTSD, Intervention and Practice Research for Combat Related Mental Disorders and Stress Reactions. 

For additional information on NIMH interests, opportunities, and contacts see PA-07-313, PA-07-314, PAR-07-315 , PA-07-312, http://www.nimh.nih.gov/about/organization/nimh-extramural-research-programs.shtml and http://www.nimh.nih.gov/about/organization/extramural-programs-and-contacts-listed-by-division.shtml\

Background

U.S. military personnel and their Families have endured many challenges since September 11, 2001.  In 2006, there were approximately 2.5 million non-civilian military personnel serving our country; of which 1.6 million are or have been deployed in support of the war efforts in Afghanistan (Operation Enduring Freedom) and Iraq (Operation Iraqi Freedom) (OEF/OIF).  These sustained combat operations have resulted in military personnel experiencing increased numbers and lengths of deployments and greater exposure to stressors, including exposure to death, risk to life, sustained threat of injury or actual injury, and the day-to-day and family stress inherent in all phases of the deployment cycle and post-deployment adjustment.  Negative life stress has been shown to be a major contributor to both the onset and exacerbation of substance abuse and mental health problems. 

Effective prevention and treatment efforts for active duty personnel, Veterans and their Families are needed to address a large public health gap.  Given the numbers of service members, Veterans and their Families who are likely to need prevention and treatment interventions for substance use disorders (SUD) in coming years, researchers are encouraged to develop new prevention and treatment interventions or adapt, test and disseminate existing evidence-based interventions that are likely to improve outcomes for populations with substance abuse alone or in combination with comorbid conditions.  In addition, health care efficiencies may be gained by leveraging technological developments (e.g, internet or telephone monitoring of interventions, web-based screening).

This FOA seeks research focused on the identification of risk and protective factors, screening for problems, the development and testing of prevention and treatment interventions, including effective policies for  reducing substance use and abuse, and testing the exportability and feasibility of existing evidence-based prevention interventions and services for substance use and abuse alone or with comorbid conditions across the Deployment Cycle (DC) for military personnel, Veterans and their Families.

The DC consists of seven stages: Train-up / Preparation, Mobilization, Deployment, Employment, Redeployment, Post-deployment and Reconstitution (e.g., Pincus, House, Christensen & Adler, 2005, Morris, 2006).  During the train-up/preparation stage individuals and units receive training and readiness activities to ensure that military personnel and their Families are prepared for extended deployments. At mobilization, units or individuals and their Families are alerted to the possibility of deployment and undergo preparation consisting of administrative actions, briefings, training, counseling, and medical evaluations.  Deployment refers to the actual move to and installation of the military personnel into the designated theater.  During the employment stage personnel perform their assigned mission. The redeployment stage involves preparations for returning personnel, equipment, and materiel to the home station and begins the process of reintegrating personnel into their pre-deployment environments.  The post-deployment stage consists of administrative actions, briefings, training, counseling, and medical evaluations to facilitate the continued successful reintegration of military personnel into their Families and communities.  The reconstitution stage begins after completing post-deployment recovery and includes briefings, training, counseling, and medical evaluations aimed at continuing the process of reintegrating into family, community, and where applicable, civilian jobs.

For the purpose of this RFA these stages have been condensed into three stages and one stage has been added to provide focus on the family component.  The revised four stages are called: 1. Pre-deployment which combines train-up/preparation and mobilization; 2. Deployment which combines deployment and employment; 3. Re-integration which includes redeployment, post-deployment and reconstitution; and 4. Separation and post-separation, which refers to leaving the service. 

Pre-deployment

It should be noted that during this stage the functional health of service members compares favorably with other civilian and military populations (Smith et al., 2007).    Battlemind training is an example of a pre-deployment universal prevention intervention developed by Army researchers and is designed to help foster resiliency and reduce stigma associated with help seeking behavior among Soldiers.  Military personnel receiving pre-deployment Battlemind training reported fewer mental health problems during deployment (MHATV, 2008). 

Deployment

Deployment is a major transition for the military member and family, during which the military member must accommodate to the new environment, routines, tasks and the threat of physical harm or death.  Several epidemiologic studies examined the well-being of deployed service members and suggested negative outcomes for substance abuse and mental health. With regard to substance use and abuse, 2007 data showed that 8% reported using alcohol in theater and 1.4% reported using illegal drugs/substances (MHAT V, 2008).  Inhalants were also a problem with 3.8% of soldiers having reported they huffed. Younger service members with combat exposures had increased rates of new-onset heavy weekly drinking, binge drinking, alcohol-related problems and increases in smoking initiation and relapse (Jacobson et al., 2008; Smith et al., 2008). Additionally, there was a multiple deployment effect associated with using alcohol, such that personnel were significantly more likely to report using alcohol in their second deployment as compared to their first deployment.  In addition to the effects of deployment on the military member, there is emerging evidence of the effects on the family.  For example, Gibbs et al. (2007) reported the rate of child maltreatment in Families of U.S. Army enlisted personnel was 42% higher during combat than in non-deployment.  In sum, there are serious and adverse consequences of deployment on health, suggesting a window of opportunity for prevention interventions before SUD and or comorbid conditions become entrenched

Re-integration

The Department of Defense (DOD) mandates post-deployment screening to identify individual health care needs to include servicemembers at risk for behavioral health problems, including alcohol related-related problems.  Screening is not routinely conducted for tobacco use at this time.  Those screened three to six months after their return were referred for further assessment and care at significantly higher rates compared to the initial post-deployment screening (Milliken, Auchterlonie, & Hoge, 2007).  Clinicians identified 20% of active and 42% of reserve component military personnel required mental health referrals when both screenings were combined. Alcohol problems were frequently reported; however, very few were referred to alcohol treatment (Miliken, Auchterlonie, & Hoge, 2007).  It is worth highlighting that post-deployment screening does not include questions about most illicit drug use or prescription drug misuse.  As such, the rates of illicit or prescription drug misuse among returning troops with drug use disorders is unclear. Additionally, military regulations regarding substance use in some cases may deter people from seeking treatment for fear of jeopardizing their careers.  Guard, Reservists and family members not living within close proximity to a Veterans Administration (VA) or military medical facility may also have difficulty accessing substance abuse treatment programs and services. 

Separation and Post-Separation

Those who separate from the service experience similar problems to those who return and stay in the service.  Of the first 299,585 OEF/OIF Veterans accessing the VA healthcare, the top two reasons for presentation were various types of somatic pain (primarily joint and back pain) and mental health problems. Within the mental health problem category the top three complaints in order were PTSD, Abuse of Drugs, and Depression (VHA Office of Public Health and Environmental Hazards, 2008).   Interventions that target and treat SUDs and mental health problems may reduce symptoms and prevent disorders.  These findings clearly highlight the need for evidence-based interventions targeting SUDs and comorbid mental health problems for Veterans.

Comorbidity

Another issue to consider is the high rates of comorbidity between SUDs and psychological disorders, such as PTSD, depression, anxiety, chronic pain, etc.  Prevention interventions and treatments that target both SUDs and comorbid disorders are often clinically warranted.  The data are equivocal as to whether the presence of a comorbid disorder alters or attenuates treatment responses within substance abuse treatments (Ford et al., 2007; McNamara et al., 2001; Trafton et al., 2006).  Drug abuse prevention interventions have shown to prevent or decrease severity of mental health problems (e.g., Connell & Dishion, 2008; Mason et al., 2007).  In addition, research suggests that certain addiction treatments which do not specifically target PTSD symptoms can produce significant improvements in both SUDs and PTSD (McNamara et al., 2001, Hien, et al., 2004).  However, other data suggest that integrated treatments can successfully decrease rates of both SUD and PTSD. 

Stigma

Stigma associated with divulging mental health problems and treatment in the military and VA health system is widely assumed, but not well documented (e.g., Hoge et al., 2004).  There is equal, if not greater stigma attached to divulging drug use and abuse problems.  This may reflect the low tolerance policies of the military regarding illegal drug use and abuse, placing military personnel seeking treatment for drug abuse at risk of being discharged and losing benefits.  These constraints make drug abuse in the military a difficult topic to study. 

National Guard and Reserves: A special population

Military operations have been described as particularly difficult for reserve and National Guard families who have less access to military support systems and fewer connections to other military families.  In addition, deployed Reserve and National Guard personnel with reported combat exposures are at increased risk of new-onset heavy weekly drinking, binge drinking, and alcohol-related problems (Jacobson et al., 2008).  It has already been noted that reserve component military personnel required more mental health treatment upon their return in comparison to active duty personnel (Miliken et al., 2007). 

In sum, the purpose of this FOA is to fund research on epidemiology/etiology, screening and identification, development and testing of prevention and treatment interventions, including policy interventions, and the adaptation and testing of efficacious substance use and abuse prevention interventions for those serving or who have served in OEF and/or OIF and their Families. All arms of the military are of interest, and Reserves, National Guard, and Veterans are of particular interest.  Research should consider the deployment cycle, from pre-deployment through separation, as this knowledge helps to define the nature and scope of the challenges these populations are likely to experience as well as the interventional approach.  Applications are required to propose theory-based research on the epidemiology/etiology, screening, development and testing of prevention interventions, adaptation and testing of efficacious prevention interventions for drug use and abuse (drug use and abuse may include alcohol, tobacco, illegal drugs, and misuse of prescription drugs) alone or in combination with associated comorbidites and the development or testing of treatment interventions for substance use disorders with or without associated comorbid conditions (e.g., PTSD, TBI, depression, anxiety, etc.) in military personnel or Veterans to be considered responsive to this FOA.

Study Topics:

Limits related to confidentiality concerning research data that involves reporting of illegal behavior by active duty military personnel has the potential to impact the generalizability of data collected from these individuals. Therefore, it is expected that studies using active duty populations will mainly focus on collection of outcomes of legal substances and prescription drug abuse. Studies conducted with family members or Veterans may target illicit, legal, and prescription drug use disorders. 

Epidemiology and Etiology

One primary objective of this FOA is to stimulate research on epidemiology/etiology of drug use and drug use disorders and prescription drug misuse among recently deployed military service members, recent veterans, and their family members.

Potential topics for epidemiology/etiology applications under this FOA include but are not limited to: 

Prevention

A second primary objective of this FOA is to stimulate research on universal approaches for the prevention of drug use onset and progression to drug abuse and dependence, drug related problems (e.g., interpersonal and familial violence, and lost productivity), and drug related mental health problems and disorders among OEF/OIF military personnel, Veterans and their Family members. Prevention interventions for substance use and abuse and associated difficulties can include universal, selective, indicated and tiered interventions.  Please see PA-08-217:  Drug abuse Prevention Intervention Research and PA-08-217:  Drug Abuse Prevention Intervention Research (R21) for a description of the levels of prevention intervention.  Applications may include: 1) trials of interventions already being utilized with OEF/OIF military members, Veterans or their Families that have not been evaluated, 2) development and testing of interventions, or 3) adaptations of interventions shown to be efficacious with civilian populations for use with military personnel, Veterans, and their Families. Prevention interventions should focus on increasing resilience and intrapersonal, interpersonal and familial functioning in order to prevent drug use and abuse and associated adjustment problems.  Additionally, data suggests that some military members initiate tobacco use after entering military service (Nelson, 2008);  interventions may also target environmental policies that have the potential to promote or impede tobacco use by military members. One major consideration is the military/Veteran context including the infrastructure and policies related to the provision of intervention services (e.g., Army Regulation 600-85: The Army Substance Abuse Program; http: //www.army.mil/USAPA/epubs/pdf/r600_85.pdf).  Potential study topics for prevention interventions include but are not limited to:

Treatment

A third primary objective of this FOA is to stimulate research on behavioral or  behavioral and integrative treatment of substance use disorders (SUD) to improve existing SUD and dual disorder treatments for any of the following groups: 1. Service members actively involved in or supporting OEF/OIF,  2. Veterans of these wars, and/or 3. Family members of active service personnel or Veteran populations who have SUD diagnoses.

Efficacious behavioral and pharmacotherapy substance use disorder (SUD) treatments have been developed for treating use/abuse in civilian populations, but it is not clear to what extent these may be applicable for military or veteran populations or their family members.  Usual care for SUD in the VA appears to be efficacious (Moos et al., 1999), but programs have undergone shifts from inpatient to outpatient models and many veterans are likely to be seen in their communities by non-VA providers (for example, those residing in rural communities). Additionally, some SUD treatments have not worked when tried in VA settings. For example, in VAs Cooperative Study #425, a trial of naltrexone for alcohol use in over 600 veterans failed to outperform placebo although previous trials in civilian populations found beneficial effects (Krystal et al., 2001). There are effective treatments for tobacco dependence, however, as with the civilian population, military and veteran populations and their families, may experience difficulty accessing them.

Because veteran populations may differ in many respects from community drug abuse treatment populations, it is not clear if, or the extent to which the research findings derived from civilian populations will generalize to active duty or veteran populations. Furthermore, it remains an empirical question as to whether introducing efficacious treatments for SUD might improve care or to what extent delivery of alternative approaches through non-traditional means (for example, computerized Cognitive Behavioral Skills training) might improve results from usual care.

Applications concerning treatment are expected to be consistent with the Stage Model of Behavioral Therapy Development. Please see PA-07-111: Behavioral & Integrative Treatment Development Program (R01) (http://grants.nih.gov/grants/guide/pa-files/PA-07-111.html ) and PA-06-487 Behavioral and Integrative Treatment Development Program (R21)  (http://grants.nih.gov/grants/guide/pa-files/PA-06-487.html ) for a complete description of the Stage Model of Behavioral Therapy Development including Stage I, II, and III treatment development and testing requested in this FOA.   Fully powered randomized controlled clinical trials are appropriate in cases where pilot data suggests feasibility and preliminary evidence of efficacy. In other cases, pilot studies are encouraged. To be responsive to this FOA, applications testing treatments must measure changes in substance use outcomes (for example, abstinence as measured by drug free urine sample submission or number of relapses as measured by either days with self reported use or drug positive urine samples). As appropriate, investigators are encouraged to measure outcomes associated with substance use such as HIV risk behavior and changes in co-morbid disorder symptoms. It is expected that applications for treatments of dual disorders measure changes in the substance use and comorbidity outcomes as primary outcomes.    

This FOA particularly encourages behavioral and integrative treatment studies that address the need for and benefits of integrated treatments for substance use and comorbid conditions (PTSD, anxiety, depression, sleep disorders, chronic pain, TBI), as well as the sequencing of treatments for dual disordered populations as it relates to SUD treatment outcomes. 

Other potential study topics for applications on drug abuse treatment include but are not limited to development and/or testing of:

Research to assess and/or adapt effective  tobacco dependence treatments, (behavioral and pharmacological) used in the civilian populations to the context of the military.  Many military personnel report using tobacco to relieve stress; interventions are especially needed that address this factor, in the context of deployment and combat. Development and testing of preventive interventions designed to address relapse to smoking and/or smokeless tobacco use during or after deployment.

Special Considerations

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

National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects:  The National Advisory Council on Drug Abuse (NACDA) recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects.   Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects.  The guidelines are available on NIDA's Web site at http://www.nida.nih.gov/about/organization/nacda/CouncilStatement.html.

Networking Website for Consultation and Collaboration

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

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

Section II. Award Information


1. Mechanism of Support

This FOA will use R01award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.  

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

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

2. Funds Available

For this FOA combined with the parallel R21 FOA (RFA-DA-10-002), the participating organizations intend to commit approximately $7.0 million (total costs) in Fiscal Year 2010 with which it is expected that 11 to 21 new grants will be funded across the two FOAs.  Specifically, in Fiscal Year 2010, NIDA intends to commit approximately $2.0 million (total costs), NIAAA intends to commit approximately $2.0 million (total costs), and NCI intends to commit approximately $1.0 million (total costs).  In addition, the VA Clinical Science Research and Development Service (CSRD) estimates committing up to $2.0 million (total costs) for this FOA (VA encourages applications to the R21 but will not participate in funding the R21 proposals).

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.

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions


The following organizations/institutions are eligible to apply:

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. In order to be eligible for VA funding,  all VA eligibility criteria must be met by applicants.    (See http://www.research.va.gov and VHA Handbook 1200.15 ).

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

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

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

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

Consideration of Applications. Applicants agree that applications submitted will be considered for funding by NIDA, NIAAA, NCI or the VA, and that the applications and all related materials will be shared.

Resubmissions.  Resubmission applications are not permitted in response to this FOA.

Renewals. Renewal applications are not permitted in response to this FOA

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the “Apply for Grant Electronically” button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

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

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

2) Organizational/Institutional Registration in the eRA Commons

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

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.

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

1. Request Application Information

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

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

For further assistance, contact GrantsInfo -- Telephone 301-435-0714; 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. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

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

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

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

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

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

Applications from Foreign organizations must:

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

SPECIAL INSTRUCTIONS  

Applications with Multiple PDs/PIs

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

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

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

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled “Multiple PD/PI Leadership Plan” [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, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

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

Applications Involving a Single Institution

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

Applications Involving Multiple Institutions 

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

When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 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: November 22, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): November 23, 2009  
Application Due Date(s): December 22, 2009
Peer Review Date(s): February/March 2010
Council Review Date(s): Mayy 2010
Earliest Anticipated Start Date(s): July 2010

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: NIDALetterofIntent@mail.nih.gov

Applicants are encouraged to send the letter of intent by email to the email address above but as an alternative the letter may also be sent to:

Director - DA-10-001
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD  20892-8401
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-2755
FAX:  (301) 443-0538

3.B. Submitting an Application Electronically to the NIH

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

3.C. Application Processing

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

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday – Friday, excluding Federal holidays) to view the application image to determine if any further action is necessary.

Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the IC. Incomplete and non-responsive applications will not be reviewed.

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

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the 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. All VA awards must meet all VA eligibility criteria.  (See http://www.research.va.gov and VHA Handbook 1200.15 )

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

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

6. Other Submission Requirements

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

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

Organizational DUNS

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

PHS398 Research Plan Component Sections

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

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

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 where 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 (go to 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 the National Institute on Drug Abuse and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below. Representatives of NIAAA and VA CSRD may attend the reviews. 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information


1. Award Notices

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

If the application is under consideration for funding, NIH or the VA 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.  For VA awardees, the CSRD will provide notification of approval to the PI’s VA Medical Center.

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

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

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

Section VII. Agency Contacts


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

1. Scientific/Research Contact(s):

Eve E. Reider, Ph.D.
Acting Branch Chief
Prevention Research Branch
National Institute on Drug Abuse
6001 Executive Blvd.
Rm. 5185 MSC 9589
Bethesda, MD  20892-9589
Telephone:  (301) 402-1719
E-mail:  ereider@mail.nih.gov

Cecelia McNamara Spitznas, Ph.D.
Program Official
Behavioral and Integrative Treatment Branch
National Institute on Drug Abuse
6001 Executive Blvd.
Rm. 3156 MSC 9553
Bethesda, MD  20892-9553
Telephone:  (301) 402-1488
E-mail:  spitznasc@mail.nih.gov

Angela M. Martinelli, PhD, RN, CNOR
CAPT, U.S. Public Health Service
Health Science Administrator 
Division of Treatment and Recovery Research
National Institute on Alcohol Abuse and Alcoholism
Room 2038, 5635 Fishers Lane, Rockville, MD 20852
Phone: 301.451.8507. Fax 301.443.8774
Email angela.martinelli@nih.gov

Michele Bloch, MD, PhD
Medical Officer, Tobacco Control Research Branch
Behavioral Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute 6130 Executive Blvd., MSC 7337
Executive Plaza North Room 4036
Bethesda, MD 20892-7337
Phone: 301-402-5284
Fax:     301-496-8675
Email:  blochm@mail.nih.gov

Terri Gleason, Ph.D.
Clinical Science R&D Service (121E)
Department of Veterans Affairs
810 Vermont Avenue NW
Washington, DC 20420
Telephone:  (202) 461-1689
Email:  Theresa.gleason@va.gov

2. Peer Review Contact(s):

Teresa Levitin, Ph.D.
Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD 20892-8401
Telephone: (301) 443-2755
Fax: (301) 443-0538
Email:
tlevitin@mail.nih.gov

3. Financial/Grants Management Contact(s):

Debra Dudley
Grants Management Branch
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Blvd., MSC 9541
Rockville, MD 20892-9541
Telephone: (301) 443-6710
Fax: (301) 594-6849
Email:
ddudley@nida.nih.gov

Judy S. Fox
Chief, Grants Management Branch
Chief Grants Management Officer
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3023, MSC 9304
Bethesda, MD  20892-9304
FOR EXPRESS MAIL:  Rockville, MD  20852-1705
Phone:  301-443-4704
FAX:  301-443-3891
Email:  jfox@mail.nih.gov

Crystal Wolfrey
Chief, Grants Branch D
Office of Grants Administration
National Cancer Institute
National Institutes of Health
6120 Executive Blvd., Suite 243
Bethesda, MD 20892 (for regular mail)
Rockville, MD 20852 (for hand delivered mail)
Phone:(301) 496-8634

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 institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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

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

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

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

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

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.

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. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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