Expired PA-06-308: Health Services Research on the Prevention and Treatment of Drug and Alcohol Abuse (R03)

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

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

Title: Health Services Research on the Prevention and Treatment of Drug and Alcohol Abuse (R03)

Announcement Type

This is a modification of PA-05-139, which was previously released July 14, 2005, and is now divided into separate Funding Opportunity Announcements (FOAs) for the R03, R21, and R01 grant mechanisms.

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

October 6, 2008 - This PA has been reissued as (PA-08-265).
October 4, 2007 - Expiration Date adjusted to accommodate recent changes to standing submission deadlines, per NOT-OD-07-093.

NOTICE: Applications submitted in response to this 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.

Two steps are required for on time submission:

1) The application must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the submission/receipt date (see Key Dates below).

2) Applicants must complete a verification step in the eRA Commons within two business days of notification from NIH. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the Commons.

Program Announcement (PA) Number: PA-06-308

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

Key Dates
Release/Posted Date: March 31, 2006
Opening Date: May 2, 2006 (Earliest date an application may be submitted to Grants.gov
Letters of Intent Receipt Date(s): Not Applicable
Application Submission/Receipt Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm.
AIDS Application Submission/Receipt Date(s): Please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): Please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Council Review Date(s): Please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Earliest Anticipated Start Date: See http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: September 2, 2008 (now September 8, 2008 per NOT-OD-07-093)

Due Dates for E.O. 12372
Not Applicable.

Additional Overview Content

Executive Summary
This Funding Opportunity Announcement (FOA) solicits health services research on the prevention and treatment of drug and alcohol abuse. Proposed research might emphasize any of the following subjects: (1) Factors that affect the delivery of drug and alcohol abuse intervention and related services, such as social factors, personal behaviors and attributes, financing, organization, management, and health technologies; (2) Dimensions of drug and alcohol abuse intervention and related services, such as accessibility, utilization, quality, effectiveness, and costs; (3) Processes of blending science-based practices into community-based provision of drug and alcohol abuse prevention services; and (4) Research tools to facilitate higher quality health services research on drug and alcohol abuse.

The goals of the health services research programs at both the National Institute on Drug Abuse (NIDA) and the National Institute on Alcohol Abuse and Alcoholism (NIAAA) are to answer questions central to the delivery of prevention and treatment services for all substances of abuse: What works? Under what circumstances? For which conditions? and, At what cost? These questions may be studied from multiple perspectives, including those of the individual drug user or drinker; the individual's family, friends, and employer; the treatment provider and the provider's organization; of other organizations affected by problems of drug and alcohol abuse (e.g., criminal justice, social service, public health); and of purchasers of drug and alcohol abuse prevention and treatment services.

In past decades, health services research sought to improve health outcomes by improving overall care and individual components of care. More recently, researchers have begun to focus on understanding outcomes in the context of a system of care that interacts over time with those who have drug and/or alcohol problems, and that also interacts with other health and social systems in ways that affect the long-term health of individuals with, or at risk for developing, drug and/or alcohol use disorders. An important aspect of both NIDA's and NIAAA's health services research programs is to improve the transfer and adoption of science-based prevention and treatment practices into healthcare and social service settings. A cross-disciplinary research approach may be required to understand how social factors, personal behaviors and attributes, financing systems, organizational structures and processes, management practices, and health technologies affect the accessibility, utilization, quality, effectiveness, and cost of drug and/or alcohol abuse prevention and treatment, particularly when the disorder is a chronic or persistent condition.

NIDA and NIAAA seek to stimulate research that will improve the accessibility, utilization, quality, effectiveness, and costs of prevention and treatment of drug use disorders and/or alcohol-related problems , and ultimately to reduce the consequences of drug and/or alcohol use and co-occurring medical, psychiatric, and behavioral problems. Equally important is production of new knowledge to help blend evidence-based drug and/or alcohol abuse prevention and treatment strategies into community practice (also known as Type II translational or implementation research). To that end, this PA encourages investigators to design research that will advance the delivery of drug and/or alcohol abuse care so that science-based prevention and treatment services are adopted in diverse settings, effectively implemented by a range of providers, and produce sustainable effects at reasonable cost for all those who need intervention. NIDA and NIAAA also encourage investigators to develop new study designs, measurement instruments, and data analytic methods that will facilitate a new generation of health services research.

Investigators should use the most rigorous research designs and data analytic procedures possible, given the purposes of their research. Proposed research should be hypothesis driven and theory-based. In designing research, investigators, should be fully aware of the complex social and psychological processes that lead to drug or alcohol use initiation, progression, and escalation to abuse. Investigators should also be aware of other important service delivery considerations, including developmental appropriateness for clients of different ages; gender sensitivity; cultural relevance; health disparities; co-occurring mental, social, and medical conditions; and links between drug and/or alcohol abuse and sexually transmitted and other infectious diseases. NIDA and NIAAA are especially interested in health services research that builds on the investments of other entities that address drug abuse, including but not limited to NIDA's Clinical Trials Network (CTN), NIDA's Criminal Justice Drug Abuse Treatment Studies (CJ-DATS), the Substance Abuse and Mental Health Services Administration (SAMHSA), state agencies, and private foundations. NIDA and NIAAA also welcome research proposals to conduct analysis or meta-analysis of existing data sets, or of diverse data sets that can be integrated to generate new knowledge. NIDA and NIAAA encourage timely reporting of findings, facilitation of practitioner access to and use of findings, and braiding of research questions with the information needs of service providers through collaborative partnerships.

A report issued by the Blue Ribbon Task Force on Health Services Research at NIDA describes the current state of health services research at NIDA and offers recommendations for boosting the relevance and use of drug abuse research in practice and policy (See full report at http://www.drugabuse.gov/about/organization/nacda/HSRReport.pdf). The Task Force prefaced their recommendations with acknowledgement of several unique policy, financing, and service delivery aspects of the drug abuse field that influence the nature of intervention services and the adoption (or not) of science-based interventions in real-world settings. Among these unique aspects are the following:

The Task Force noted that safe and efficacious interventions are available to help prevent and reduce drug use and related criminal activity, interpersonal problems, and other risky behaviors, and also to help improve school, social, and job functioning. Yet, few communities provide sufficient intervention services to meet local needs, and improvements in prevention and treatment services in non-research settings have been limited. Moreover, investigator-initiated research rarely has examined or refined interventions that are widely practiced and relevant to clinicians.

To address these gaps, research is needed to examine the healthcare services, service delivery systems, technology transfer processes, and policies that affect provision of effective substance abuse prevention and treatment in real world settings (e.g., community clinics, primary care clinics, hospitals, prisons, schools, social service agencies, faith-based organizations). Findings from such research should have practical implications for the range of individuals and groups affected by or at risk for substance use problems, including individuals and their families, clinicians, healthcare administrators, policymakers, purchasers, and insurers.

Appropriate and fundable research under this PA falls into the following four related and overlapping areas:

Examples given below further clarify these four areas. These examples are illustrative, not exhaustive, and topics not mentioned should not be considered excluded under this Funding Opportunity Announcement (FOA).

Social Factors and Personal Behaviors and Attributes. Research on the personal and social factors that can affect accessibility, utilization, quality, effectiveness, and costs of drug and/or alcohol abuse prevention and treatment services largely is concerned with underserved populations. These populations are defined by many dimensions, including age; gender; sexual orientation; race/ethnicity; socioeconomic status; geographic location of residence; presence of co-occurring medical, psychiatric, or behavioral conditions; and participation in criminal activity; among others. Prevention and treatment services may need to be tailored for specific populations in order to address their unique needs, but little is known about how to assess client needs and target services based on these various factors. NIDA and NIAAA are especially interested in research on health disparities associated with these and other factors, including studies of service distribution and the concept of health equity. Areas of research interest include the following:

Financing. Research on financing drug and/or alcohol abuse prevention and treatment examines health insurance and/or payment mechanisms, alternative delivery systems and managed care, alternative payment systems, public and private financing systems, and the design of insurance. For those interested in doing finance studies, a separate FOA is available at PA-05-111, Economics of Prevention and Treatment Services for Drug and Alcohol Abuse, released May 18, 2005.

Organization. Organizational research is concerned with examining structural (e.g., size, shape, charter, staffing) and environmental (e.g., climate, culture) factors that can affect service efficiency and effectiveness. NIDA and NIAAA are particularly interested in organizational change processes associated with improvements in therapeutic and business practices. On a micro level, research is needed to improve the environment in which care is delivered, from the perspective of both client and provider. On a macro level, research is needed on how provider organizations structure and coordinate prevention and treatment services, and on how they interact with other health, psychiatric, and social service delivery agencies to meet the needs of at-risk or substance using populations. Given the chronic relapsing nature of drug and alcohol dependence for many individuals, organizational research should incorporate such issues as continuity of care, availability and quality of services, service utilization patterns, and their relationship to overall health outcomes. Areas of research interest include the following:

Management. Management research is concerned with improving the effectiveness and efficiency of work practices, including practices related to delivering therapeutic services (e.g., medications, individual/group counseling) and to conducting the day-to-day business operations that sustain services (e.g., client screening; case management; quality control; staff recruitment, training, supervision, and retention). The synergy between business and therapeutic practices has received little attention in health services research on drug and/or alcohol abuse prevention and treatment. Areas of research interest include the following:

Health Technologies. Research on health technologies involves studies to understand how the introduction and implementation of new business and intervention technologies affect accessibility, utilization, quality, effectiveness, and costs of drug and/or alcohol abuse prevention and treatment services in all community care settings. For example, new health technologies may have direct and indirect effects on client identification and diagnosis, service delivery, data collection, information sharing, and management of substance abuse and related medical conditions (e.g. brain imaging, saliva testing for HIV, web-based service delivery, multi-agency management information systems). Areas of research interest include the following:

Accessibility and Utilization. Research on the accessibility and utilization of prevention and treatment services deals with demand and availability of services and the factors that facilitate or hinder service access and use. A focus on health disparities is warranted because of the difficulty special populations often have in accessing and using drug abuse prevention or treatment services. Areas of research interest include the following:

Quality. Research on the quality of drug and alcohol abuse prevention and treatment services is concerned with optimizing the content, intensity, pace, modality, and timing of prevention and treatment interventions in order to maximize effectiveness. Once these optimal characteristics are identified and defined, standards of care and performance indicators can be established to guide providers in delivering high-quality services, help users select high-quality services, and assist funders and policymakers in monitoring service quality. Areas of research interest include the following:

Effectiveness. New research on the effectiveness of drug and/or alcohol abuse prevention and treatment services should extend beyond the question of whether services and service systems work in real-world settings to uncover how and why they work, for which individuals, under what circumstances, and at what cost? Areas of research interest include the following:

Costs. Economic research informs decisions related to the allocation of resources and the improvement of service efficiency and equity. Studies are sought on the economics of drug and/or alcohol abuse services for prevention and treatment, especially for research on alternative payment systems, public and private financing systems, and the design of insurance. For those interested in doing cost studies, a separate FOA is available at PA-05-111, Economics of Prevention and Treatment Services for Drug and Alcohol Abuse, released May 18, 2005. Investigators of cost evaluations may wish to develop their own studies or collaborate with other studies that are either ongoing or in the planning stage.

Research to translate evidence-based drug and/or alcohol abuse treatment interventions into community practice and to prompt wider use of new prevention strategies focuses on knowledge transfer, organizational change, and innovative financing strategies. NIDA and NIAAA view this type of translational science as a complex multidirectional blending process that involves the interaction of multiple individual- and systems-level factors. The process often involves providers recognizing a problem; finding information about science-based innovations that may address the problem; searching for a solution by assessing available innovations, often in comparison with usual practice; adopting an innovation that appears promising for some clients; and then implementing, reconsidering, adapting, and, sustaining use of the innovation over time. This view, although complex, acknowledges the multidirectional and iterative nature of innovation and practice improvement.

State, county, and municipal Alcohol and Drug Abuse Agencies have a unique and powerful role in bridging the gap between science and services. As administrators of publicly supported substance abuse service delivery, public health agencies are well positioned to bring synergy, coherence, accountability, and long-term success to practice improvement in drug and/or alcohol abuse prevention and treatment services. Because they set policy and allocate service resources, public health agencies can influence the nature and pace of innovation adoption. NIDA and NIAAA encourage these agencies to conduct the research they need to develop, implement, and sustain statewide adoption of meritorious science-based policies and therapeutic and business practices. Moreover, NIDA and NIAAA encourage research grant applicants to incorporate in their projects SAMHSA-supported activities designed to foster adoption of science-based practices, including State Incentive Grants (SIGs), and other service infrastructure development and block grants.

Research on methods and instruments involves the development, refinement, and validation of new tools for examining how social factors, financing systems, organizational structures and processes, management practices, health technologies, and personal beliefs and behaviors affect the demand for and delivery of drug and/or alcohol abuse healthcare and related services specifically the accessibility and utilization, quality, effectiveness, and costs of healthcare and related services for the prevention and treatment of drug and/or alcohol abuse and the medical consequences of such abuse. Areas of research interest include the following:

1. Mechanism of Support

This funding opportunity will use the NIH Small Research Grant (R03) award mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses just-in-time concepts. It also uses the modular budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement. All applications submitted in response to this FOA must use the modular budget format. Specifically, since you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, Modular Budget Component, of the Application Guide).

Competing renewal (formerly competing continuation ) applications will not be accepted for the R03 grant mechanism. Small grant support may not be used for thesis or dissertation research. Up to two resubmissions (formerly revisions/amendments") of a previously reviewed small grant application may be submitted. See NOT-OD-05-046, April 25, 2005.

2. Funds Available

Although the financial plans of the NIH 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.

A project period of up to two years and a budget for direct costs of up to two $25,000 modules, or $50,000 per year, may be requested (i.e., a maximum of $100,000 over two years in four modules of $25,000 each). Commensurate F&A costs are allowed.

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

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

1.B. Eligible Individuals

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

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.

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/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 eRA Commons.

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

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

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

1. Request Application Information

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

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

For further assistance contact GrantsInfo, Telephone 301-710-0267, 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 (MS Word or PDF).

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 Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.

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

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

Optional Components:

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

Note: While both budget components are included in the SF424 (R&R) forms package, the NIH R03 uses ONLY the PHS 398 Modular Budget. (Do not use the detailed Research & Related Budget.)

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

3.B. Sending an Application to the NIH

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

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.

Upon receipt, applications will be transferred from Grants.gov to the NIH Electronic Research Administration process for validation. Both the PD/PI and the Signing Official for the organization must verify the submission via Commons within two (2) business days of notification of the NIH validation.

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

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

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

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

6. Other Submission Requirements

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

Renewal (formerly competing continuation or Type 2 ) applications are not permitted.

All application instructions outlined in the SF424 (R&R) Application Guide (MS Word or PDF) are to be followed, with the following requirements for R03 applications:

Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan 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.

Plan for Sharing Research Data

Not Applicable.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/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.

1. Criteria

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

2. Review and Selection Process

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

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

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 NIH R03 small grant is a mechanism for supporting discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the research plan is restricted to 10 pages, a small grant application will not have the same level of detail or extensive discussion found in an R01 application. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem, placing less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.

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 comments, 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. The scientific review group will address and consider each of these criteria in assigning the application's 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 scientific health problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

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

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

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

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

2.A. Additional Review Criteria

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

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See item 6 of the 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 item 7 of the 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 five items described under item 11 of the Research Plan component of the SF424 (R&R) will be assessed.

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. Is the percent effort listed for the PD/PI appropriate for the work proposed? Is each budget category realistic and justified in terms of the aims and methods?

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/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 will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., Reporting.

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. For the R03 mechanism, the presence or adequacy of a plan should not enter into the scoring of the application.

1. Award Notices

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

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

1. Scientific/Research Contacts:

Direct inquiries regarding programmatic issues about drug abuse treatment services to:

Redonna K. Chandler, Ph.D.
Division of Epidemiology, Services, and Prevention Research
National Institute on Drug Abuse
6001 Executive Blvd.
Room 5177, MSC 9589
Bethesda, MD 20892-9589
Rockville, MD 20852 (for express/courier service)
Phone: (301) 443-6504
Fax: (301) 443-6815
E-mail: [email protected]

Direct inquiries regarding programmatic issues about drug abuse prevention services to:

Elizabeth Robertson, Ph.D.
Chief, Prevention Research Branch
Division of Epidemiology, Services, and Prevention Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5154, MSC 9589
Bethesda, MD 20892-9589
Telephone: (301) 443-1514
Fax: (301) 480-2542
E-mail: [email protected]

Direct inquiries regarding programmatic issues about alcohol-related services to:

Peter J. Delany, DSW
Division of Treatment & Recovery Research
National Institute on Alcohol Abuse & Alcoholism
National Institutes of Health
5635 Fishers Lane, Room 2039, MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 443-0788
Fax: (301)443-8774
E-mail: [email protected]

2. Financial or Grants Management Contacts:

Gary Fleming, J.D.
Chief, Grants Management Branch/OPRM
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Room 270
Bethesda, MD 20892-8403
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: [email protected]

Judy Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3023, MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 443-4704
Email: [email protected]

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

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

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

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

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

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

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R); 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 (http://publicaccess.nih.gov/publicaccess_manual.htm).

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

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

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

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

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

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

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

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

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