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Part I Overview Information

Department of Health and Human Services

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

Components of Participating Organizations
National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov/)
National Institute on Alcoholism and Alcohol Abuse (NIAAA) (http://www.niaaa.nih.gov)
National Center for Complementary and Alternative Medicine (NCCAM) (http://www.nccam.nih.gov)

Title: Behavioral & Integrative Treatment Development Program (R01)

Announcement Type
This is a reissue of PA-06-486, which was previously released July 14, 2006.

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

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

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

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

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

Program Announcement (PA) Number: PA-07-111

Catalog of Federal Domestic Assistance Number(s)
93.279, 93.272, 93.213

Key Dates
Release/Posted Date: December 7, 2006
Opening Date: January 5, 2007 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not Applicable
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization).
Application Submission/Receipt Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission/Receipt Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: New Date September 8, 2009 per NOT-DA-09-008, Original Date: May 2, 2009 (Changed to May 8, 2009 per NOT-OD-07-093)

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

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

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

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Purpose

The National Institute on Drug Abuse (NIDA), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), and the National Center for Complementary and Alternative Medicine (NCCAM), National Institutes of Health (NIH), are seeking research grant applications on the development and testing of behavioral and integrative treatments for drug and alcohol abuse and dependence. This Funding Opportunity Announcement (FOA) reaffirms NIDA's, NIAAA's, and NCCAM’s continued and ongoing commitment to major programs of research on behavioral and integrative treatments. The term "behavioral treatments" is used here in a broad sense and includes various forms of psychotherapy, behavior therapy, cognitive therapy, family therapy, couples and marital therapy, group therapy, skills training, meditation, yoga, tai chi (taiji), guided imagery, counseling, and rehabilitative therapies. The term, Integrative treatments refers to treatments that combine behavioral interventions with other treatments, including other behavioral therapies, medications, and/or complementary/alternative therapies. Behavioral and integrative treatment research has been conceptualized, for the purpose of this initiative, to consist of three stages. Stage I, or early treatment development, involves research on the development, refinement, and pilot testing of behavioral and integrative interventions. Stage I may include translational research that incorporates concepts, methods or findings from other disciplines (e.g., neuroscience, cognitive science, etc.) into the development of behavioral and integrative treatments. Stage I may also include research to develop or adapt treatments to become more community-friendly. Stage II includes testing treatments that show promise and testing the dose-response of treatments. Stage III is research aimed at determining if and how efficacious behavioral treatments may be transported to community settings. Stage III may include studies that test treatments in community settings, with community therapists. Stage III may also include studies that develop or test methods of training treatment providers to administer treatments. Determination of mechanism of action of treatment is relevant to all three stages. This funding opportunity announcement (FOA) replaces in its entirety PA-03-126, published in the NIH Guide, May 19, 2003 at http://grants.nih.gov/grants/guide/pa-files/PA-03-126.html.

Applicants interested in the organization, management, and economics of drug abuse treatment services, and the effects of these factors on the quality, cost, access to, effectiveness, and outcomes of care for drug abuse and addictive disorders are referred to the FOA "Drug Abuse Health Services Research" http://grants.nih.gov/grants/guide/pa-files/PA-05-139.html.

NIMH also encourages research examining innovative approaches to behavioral and integrative treatment aimed at combining and sequencing Mental Health treatment (to individualize and optimize care). NIMH supports pilot interventions research via the R34 mechanism (http://grants2.nih.gov/grants/guide/pa-files/PAR-06-248.html). This NIMH FOA encourages research in what is described in this announcement as Stage Ia and Ib (but uses different designations of these Stages).

Background and Rationale

Behavioral treatments play a critical role in most evidence-based drug abuse treatments, and often constitute the entire treatment. This FOA is intended to promote all of the necessary stages of behavioral and integrative treatment research so that better treatments are developed as advancements in science are made, and so that evidence-based treatments may be readily transported to the community. Over the past two decades, numerous evidence-based behavioral and integrative treatments for drug abuse and addiction have been created. With recent advances in science, particularly in neuroscience, it is evident that more can be done to incorporate new scientific discoveries into behavioral treatment development, in order to improve treatment effects. In addition, as more is known about mechanism of action of treatment, and as new technologies are developed, it is clear that more can be done to make treatments more easily transportable to community settings. To achieve these goals, NIDA, in partnership with NIAAA and NCCAM, is continuing the Behavioral Therapies Development Program with the release of this announcement, renamed the Behavioral and Integrative Treatment Development Program.

For alcohol abuse and dependence, most of the treatments available in the U.S. also have been behavioral in nature. A large number of clinical trials conducted over the past 15 years have demonstrated effectiveness for several types of behavioral therapies, including cognitive behavioral therapy, motivational enhancement therapy, marital family therapy, brief interventions, and the community reinforcement approach. Although progress has been made in a broad range of behavioral interventions to treat alcohol abuse and dependence, many alcoholics do not respond adequately to currently available behavioral therapies. For alcohol abuse and dependence, this FOA supports research to develop new innovative behavioral therapies or modify existing treatments to improve their effectiveness and devise ways to improve the engagement, retention, adherence, and outcome of alcoholism treatment across various populations of alcohol dependent and abuse subjects.

Behavioral and integrative treatment research has been conceptualized within a Stage Model having three stages.

Stage I. Stage I, early treatment development, is viewed as an iterative process involving: (1) identifying promising basic or clinical concepts, methods or findings relevant to treatment; (2) generating and formulating new behavioral and integrative treatments or modifying existing treatments; (3) operationally defining and standardizing principles and techniques of the treatments; and (4) pilot testing and, if necessary, refining the treatments. Stage I also involves testing the theory upon which a treatment is based to understand the mechanisms and principles of behavior change.

Although one goal of a Stage I project is to proceed to Stage II, another goal is to obtain scientific knowledge of behavioral processes that lead to behavior change. Early Stage I, or "Stage Ia" can be viewed as the most exploratory part of the treatment development process, in which theories of behavior change are tested, and the critical therapy development groundwork is laid. Late Stage I or "Stage Ib," although still exploratory, can be viewed as the phase of Stage I in which theory-relevant data continues to be obtained, and the treatment undergoes pilot testing (type of methodology is not mandated) to determine whether or not a Stage II (or Stage III) study is warranted.

When evidence-based treatments need to be adapted to be delivered by community treatment providers, that adaptation is considered to be early treatment development, a Stage I activity. Such Stage I research may be conducted with research therapists or community treatment providers. If Stage I research is conducted in this way, there may be immediate progression to Stage III.

Research on the development or modification, and pilot-testing of training procedures for treatment providers is considered a Stage I activity. After pilot testing, research on the full-scale testing of these procedures is considered to be a Stage III activity.

Stage II. Stage II research consists of testing of promising treatments. Stage II does not specify a particular research design. Testing treatments may refer to randomized clinical trials, but also may refer to other methodologies (e.g., single-case designs, A-B-A designs, etc.). Stage II studies may include examinations of the components of treatments, dose-response, and individual differences in treatment response. Stage II provides unique opportunities to further test the principles and mechanisms underlying behavioral change associated with treatment.

Proceeding to Stage II presumes that promising pilot data exist. If evidence of promise does not exist, or such evidence is not strong enough to warrant progression to Stage II, applicants are encouraged to reconsider a Stage II submission.

If results are robust, Stage II studies may progress to Stage III. However, information obtained from Stage II studies may also be used to inform future Stage I studies. For example, if it is shown that a treatment works for some people, but not for others, a Stage II study may lay the groundwork for a Stage I proposal aimed at developing a treatment (or modifying the treatment) so that it works on the patients who were unresponsive to the initial treatment.

Stage III. The ultimate goal of treatment development is to produce treatments that work, and continue to work when used in the community. Stage III research is aimed at obtaining knowledge and methods to ensure that an evidence-based treatment will retain its potency when delivered by community treatment providers. One question relevant to Stage III research is, Does this treatment work when administered by community treatment providers? Another question relevant to Stage III research is, How can this treatment be made to work when administered by community treatment providers? Stage III research does not require a particular research methodology, and may involve randomized clinical trials (of evidence-based treatments or of clinical training procedures), or a variety of other methodologies. Examination of the mechanism of action of treatments and/or training procedures is considered to be an integral part of Stage III.

Research on the development or modification of a treatment for use in a community setting is considered to be Stage I research, as is research on the development or modification of a training procedure for treatment providers.

As is the case for Stage II, information obtained from Stage III studies may also be used to inform future Stage I studies. For example, if it is shown in Stage III that a treatment works for some people, but not for others, a Stage III study may lay the groundwork for a Stage I proposal aimed at developing a treatment (or modifying the treatment) so that it works on the patients who were unresponsive to the initial treatment.

It is NIDA's, NIAAA's, and NCCAM’s objective to ensure sufficient emphasis and support for all stages of behavioral and integrative treatment research, so that scientific knowledge can readily be incorporated into newer and better behavioral and CAM interventions and treatments, and so that treatments can be effectively transported from research to the community. This PA is intended to promote this objective by encouraging research grant applications in any one of the three Stages of behavioral or integrative treatment research.

Areas Of Interest

This FOA solicits research targeting Stage I, II, and III behavioral and integrative treatment of any drug- or alcohol-abusing population, including but are not limited to women, minorities, families, couples, specific cultural groups, adolescents, the elderly, and persons with disabilities, such as the deaf. This includes research targeting the behavioral and integrative treatment of any drug of abuse, including marijuana, methamphetamine, MDMA and other club drugs, prescription drugs, inhalants, sedative-hypnotics, hallucinogens, appetite suppressants and other supplements, heroin, cocaine, nicotine, and alcohol.

It should be noted that if a subject is identified as being at risk for HIV acquisition and/or transmission, HIV testing and counseling should be offered to the subject in accordance with current guidelines. Wherever possible and appropriate, investigators are encouraged to collect data on the effect of treatment on AIDS risk behaviors, including data on the route of drug administration and sexual behaviors that may place individuals at risk for HIV transmission. Also, as appropriate, investigators should offer risk-reduction counseling and collect data on the effect of treatment on the acquisition/transmission of HIV/AIDS and other infectious diseases, such as Hepatitis C, associated with drug use.

Applicants are encouraged to include, and if necessary develop, measures of mediators of behavior change and mechanism of action of behavioral and integrative treatment in all three Stages. This may include research on the neurobiological, behavioral, cognitive, social, affective, etc. mechanism of action, and may involve any number of methodologies. If focus on mechanisms of action is not appropriate for a particular application, applicants are encouraged to address and justify why this will not be done.

Specific areas of interest include, but are not limited to:

Translational Research:

Major advances have been made in understanding how drugs of abuse alter various brain processes and systems, both structurally and functionally. Further advances in understanding the neurobiology of drug abuse, neurobiological and genetic predictors of response to behavioral treatment, and the neurobiology of the effects of behavioral treatment are imminent. Translational research linking neuroscience and/or genetics to behavioral treatment development is encouraged. Examples include, but are not limited to:

o Stage I studies developing or improving behavioral treatments and/or HIV risk reduction interventions by incorporating findings, methods, or principles from basic, clinical, cognitive, affective or social neuroscience (e.g., exercises to improve brain function).

o Stage I, II, or III translational research to develop and test components to boost treatment effects (e.g., sleep hygiene modules).

o Stage I, II, or III research linking behavioral constructs (e.g., affect regulation, attention, learning, memory, self-monitoring, craving, delay discounting, impulsivity, etc.) associated with drug abuse with their neurobiological underpinnings and behavioral treatment development.

o Stage I, II, or III research identifying neurobiological or genetic predictors of behavioral treatment response and/or developing methods for assessing these predictors.

Community-friendly treatment: For treatments to be used in community settings, they must not only work, but also must be workable in those settings. For instance, one setting may necessitate group treatment (e.g., community mental health settings with limited resources), but another setting may call for an individual-based, brief screening and treatment (e.g., in a primary care or dental office). The complexity and/or intensity of the treatment, training or additional staff requirements, fit with existing treatment programs, and of course cost can all be factors determining whether a treatment is community friendly.

Where appropriate and potentially feasible, Stage I research is needed to modify evidence-based treatments into community-friendly formats (e.g., individual to group, briefer formats, computer-assisted delivery, etc.), and to test these community-friendly treatments to determine if potency is diminished, retained, or improved. In addition, promising existing treatments, already being utilized in the community, may be the basis for a Stage I proposal, and such treatments may be operationally defined, modified, pilot tested (in Stage I), and ultimately tested in Stage III (possibly but not necessarily by-passing Stage II).

Understanding how and why a treatment works and for whom a treatment works may be critical to paring it down to its most essential elements, ultimately making it not only more streamlined and less costly, but also easier to administer and more principle-driven. Therefore, most community-friendly behavioral treatment research is inextricably linked to understanding mechanism of action. Behavioral and integrative treatment research, particularly in Stage I and Stage III, is encouraged that is aimed at determining mechanism of action while developing or adapting treatments to be community-friendly, including, but not limited to, the following:

o Group therapy Evidence-based individual treatments sometimes cannot be readily incorporated into community treatment programs. Where appropriate and potentially feasible, research is needed to modify evidence-based individual treatments into group formats, and to test these group treatments to determine if potency is diminished, retained, or improved. In addition, promising existing community-based group treatments may form the basis for a Stage I proposal, and such treatments may be operationally defined, modified, pilot tested, and ultimately tested. Research aimed at understanding the mechanism(s) of action of group treatment, e.g., research that links group treatment development to social neuroscience, basic social science, clinical science, etc., is particularly encouraged.

o Setting-specific treatment: Research is sought for behavioral and integrative treatments for use in medical and dental settings, mental health settings, the criminal and juvenile justice systems, the welfare system, workplace settings, school settings, faith-based settings, etc.

o Technology-assisted treatment and training: Research is sought at all three Stages on treatments, treatment add-ons or components, and therapist training modules, administered or assisted by technological devices and software applications such as computers, virtual reality software, the Internet, expert systems models, telephone, pagers, or hand-held computers.

o More brief, less complex, and/or less intensive treatment. Research that attempts to gain and use knowledge about how and why a treatment exerts its effects, to make that treatment briefer, less complex and/or less intensive while retaining its effectiveness-is encouraged.

o Extended behavioral and integrative treatment. It is understood that drug addiction is a chronic, relapsing disorder, and that treatment and continuing care may be required over an extended period of time. Research is needed to determine when continued treatment is necessary, how to administer extended behavioral and integrative treatments in the most community-friendly ways.

o Therapist training research. Research on how to best train treatment providers to administer specific interventions is sought.

Combined behavioral and medication treatment research: Stage I - III studies are solicited in areas such as:

o Behavioral treatment to complement and/or potentiate the effects of medications. Therapies to be utilized in conjunction with medications, to optimize the efficacy of drug/alcohol addiction treatment.

o Behavioral treatment integrated with medications for drug abusers with comorbid disorders.

o Optimal combinations and sequencing of behavioral and pharmacological treatments.

o Adherence to drug and alcohol abuse treatment medications.

Adherence to HIV and other infectious disease treatment: Stage I, II, and III studies on adherence to treatment regimens for drug abusers with infectious disease, such as HIV, Hepatitis C, etc. are needed. This includes research on drug abusers with comorbid psychiatric disorders.

HIV prevention in drug abuse treatment: Many types of drug abuse are associated with increased HIV risk. Although drug abuse treatment in and of itself may reduce HIV risk, behavioral interventions to specifically reduce HIV risk may decrease risk further. Examples of research are supported under this FOA include, but are not limited to:

o Stage I projects to develop and pilot test HIV risk reduction modules to be used in conjunction with evidence-based behavioral and integrative treatments, and Stage II or Stage III projects on these modules.

o Research aimed at decreasing sexual risk behavior in drug abuse treatment populations.

o Research aimed at decreasing HIV risk behavior in HIV+ drug abuse treatment populations.

Behavioral and brain development: As the brain develops, different treatment approaches may be necessary. Understanding the developing brain and the mechanism of action of behavioral treatments in the developing brain is critical to producing the best treatment. Behavioral and integrative treatment research is needed in, but are not limited to the following areas:

o Stage I projects linking brain development to behavioral and integrative treatment research

o Stage I research linking adolescent social behavior, family process, social neuroscience, and behavioral treatment approaches

o Stage II and III projects testing the efficacy/effectiveness of promising treatments for adolescents alone or in combination with pharmacotherapies.

Comorbidity: Substance abusers often have psychiatric and medical problems. These problems may be related to the onset and/or maintenance of drug abuse, and may affect treatment. In addition, the neurobiology of comorbid disorders may be related to the neurobiology of the addictive disorder, and may help inform treatment development. Examples of Stage I, II and III comorbidity-related behavioral and integrative research areas included in this PA are:

o Borderline personality disorder, suicide, affect regulation, neurobiology, and treatment mechanisms.

o Anxiety disorders, distress tolerance, and mechanisms of treatment.

o Translational research linking behavioral and integrative treatment development to serious mental illness, drug abuse, family and group dynamics (e.g., expressed emotion) and neurobiology.

o Obesity (or other eating disorders) and behavioral treatment development and mechanisms.

o Behavioral and integrative treatment of substance abusing patients with HIV/AIDS, hepatitis, or other infectious diseases.

Therapies to manage precipitants of relapse: Relapse to drinking or drug use is common after treatment. Patients have identified multiple precipitants of relapse including negative affect, stress, insomnia, anger, depression, anxiety, and social and environmental cues associated with prior drinking or substance use experiences. Behavioral and integrative treatments to enable patients to manage these precipitants without resorting to drinking or drug use are needed. Research on the long term maintenance of behavior change is encouraged.

Treatment engagement and retention: Stage I, II and III research is needed on behavioral interventions to enhance motivation, and to facilitate treatment engagement and retention, including outreach and engagement approaches in community and specialty clinic settings. For example, engagement and retention strategies may be informed by advances in neuroscience relating brain systems associated with trust, cooperation, empathy, and other social behaviors.

Complementary and alternative medicine treatment: To treat drug abuse, behavioral treatments are sometimes combined with complementary and alternative treatments. Research on complementary and alternative treatments is included under this program announcement, as sole treatments or as adjunctive strategies to enhance the therapeutic potency of existing drug and alcohol abuse treatments. For a detailed description of complementary and alternative treatments for alcohol and drug abuse, see Program Announcement: http://grants.nih.gov/grants/guide/pa-files/PA-05-097.html.

Special Considerations:

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

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

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

Section II. Award Information

1. Mechanism of Support

This FOA will use the NIH Research Project Grant (R01) award mechanism.

The applicant 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 http://grants.nih.gov/grants/funding/modular/modular.htm).

Specifically, if you are a U.S. organization and 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 found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.

2. Funds Available

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

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

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

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

1.B. Eligible Individuals

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

More than one PD/PI, 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 may submit more than one application, provided each application is scientifically distinct.

Section IV. Application and Submission Information

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/applicants/apply_for_grants.jsp and follow the directions provided on that Web site.

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

PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get 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 PD/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 the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

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

For further assistance, contact GrantsInfo: Telephone 301-710-0267, Email: [email protected].

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

2. Content and Form of Application Submission

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

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. 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 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.)
Research & Related Budget (required for foreign applications)

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

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

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

Applications from foreign organizations must:

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

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs

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

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

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

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

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

Applications Involving a Single Institution

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

Applications Involving Multiple Institutions

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

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

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates

Opening Date: January 5, 2007 (Earliest date an application may be submitted to Grants.gov)
Application Submission/Receipt Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission/Receipt Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/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 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. The submitting AOR receives the Grants.gov acknowledgments. The AOR and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

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

The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

Items 2-5 of the PHS398 Research Plan component are limited to 25 pages. 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 additional requirements:

Special Instructions for Modular Grant applications

R01 applications from U.S. institutions/organizations requesting up to $250,000 per year in direct costs (excluding consortium F&A costs) must be submitted in a modular budget format. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm. When submitting a modular budget, the applicant organization will include only the PHS398 Modular Budget component. See Section 5.4 of the SF424 (R&R) Application Guide for further instructions regarding the use of the PHS398 Modular Budget component.

Foreign organizations may not submit modular budgets. See NOT-OD-06-096.

Special Instructions for Applications Requesting $500,000 (direct costs) or More Per Year

Applicants requesting $500,000 or more in direct costs for any year (excluding consortium F&A costs) must carry out the following steps:

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

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

3) Include the PHS398 Cover Letter component with the application to identify the staff member and IC who agreed to accept assignment of the application.

This policy applies to all new applications, competing renewal (formerly competing continuation ) applications, resubmission (formerly revised/amended ) applications, and revision (formerly competing supplemental ) applications. See NOT-OD-02-004, October 16, 2001.

APPENDIX MATERIALS

Stop SignIMPORTANT NOTE: NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review.

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 observe the required page limitations may be delayed in the review process.

Note: While each section of the PHS398 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 monitor better 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.

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

Plan for Sharing Research Data

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

Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

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

Sharing Research Resources

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

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

Section V. Application Review Information

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

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

2. Review and Selection Process

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

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

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

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

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.

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

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

Approach: : Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? 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/PIs and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level(s) of the principal investigator(s) and other researchers? Do the PD/PIs 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:

Resubmission Applications (formerly revised/amended applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See 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. Sharing Research Data

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

2.D. Sharing Research Resources

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

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

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

Model Organism Sharing Plan: Reviewers are asked to assess the sharing plan in an administrative note. The sharing plan itself should be discussed after the application is scored. Whether a sharing plan is reasonable can be determined by the reviewers on a case-by-case basis, taking into consideration the organism, the timeline, the applicant's decision to distribute the resource or deposit it in a repository, and other relevant considerations.

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

3. Reporting

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

Section VII. Agency Contacts

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

Lisa Onken, Ph.D.
Division of Clinical Neuroscience and Behavioral Research
National Institute on Drug Abuse
6001 Executive Blvd., MSC 9551
Bethesda, MD 20892-9551
Telephone: (301) 443-2235
Fax: (301) 443-8694
E-mail: [email protected]

Robert B. Huebner, Ph.D.
Deputy Director
Division of Treatment and Recovery Research
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, MSC 9304, Room 2049
Bethesda, MD 20892-9304
Telephone: (301) 443-4344
Fax: (301) 443-8774
E-mail: [email protected]

Catherine M. Stoney, Ph.D.
Division of Extramural Research and Training
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892-5475
Telephone: (301) 402-1272
Fax: (301) 480-3621
E-mail: [email protected]

2. Peer Review Contact(s):

Not Applicable

3. Financial/Grants Management Contact(s):

Edith Davis
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Blvd., MSC 9541
Rockville, MD 20892-9541
Telephone: (301) 443-6710
Fax: (301) 594-6849
E-mail: [email protected]

Judy Fox
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Blvd., MSC 7003
Bethesda, MD 20892-7003
Telephone: (301) 443-4704
Email: [email protected]

George Tucker
Grants Management Branch
National Center for Complementary and Alternative Medicine
6707 Democracy Boulevard, Suite 401
Bethesda, MD 20892-5475 (for express/courier service use 20817)
Telephone: (301) 594-9102
Fax: (301) 480-2419
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) 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 PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 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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