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 of Mental Health (NIMH), (http://www.nimh.nih.gov/)
National Cancer Institute (NCI), (http://cancer.gov)
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD), (https://www.nidcd.nih.gov/)
Office of Behavioral and Social Science Research (OBSSR), (http://obssr.od.nih.gov/)
National Institute of Nursing Research (NINR), (http://ninr.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov/)
National Institute of Dental and Craniofacial Research (NIDCR), (http://www.nidcr.nih.gov/)
National Heart, Lung, and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov/)
Office of Dietary Supplements (ODS), (http://dietary-supplements.info.nih.gov)

Title: Dissemination and Implementation Research in Health (R01)

Announcement Type
This is a reissue of PA-02-131, which was previously released July 19, 2002.

Updates: The following updates relating to this announcement have been issued:

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

Program Announcement (PA) Number: PAR-06-039

Catalog of Federal Domestic Assistance Number(s) 
 93.242, 93.393, 93.361, 93.173, 93.279, 93.837, 93.273, 93.121

Key Dates
Release Date: October 25, 2005
Letters of Intent Receipt Date(s): 12/26/2005, 08/22/2006, 04/24/2007, 12/26/2008, 08/25/2008, 04/22/2009 
Application Receipt Dates(s): 01/24/2006, 09/22/2006, 05/24/2007, 01/24/2008, 09/24/2008, 05/22/2009
AIDS Application Receipt Dates(s):  05/01/2006, 01/02/2007, 09/01/2007, 05/01/2008, 01/02/2009, 09/01/2009
Peer Review Date(s): 06/2006, 02/2007, 10/2007, 06/2008, 02/2009, 10/2009
Council Review Date(s): 09/2006, 05/2007, 1/2008, 09/2008, 05/2009, 01/2010
Earliest Anticipated Start Date: 12/2006, 07/2007, 04/2008, 12/2008, 07/2009, 04/2010  
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date for R01 Non-AIDS Applications: September 23, 2006
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary  

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
  1. Research Objectives

Section II. Award Information
  1. Mechanism 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. Sending an Application to the NIH
    C. Application Processing
  4. Intergovernmental Review
  5. Funding Restrictions
  6. Other Submission Requirements

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

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Each year, billions of U.S. tax dollars are spent on research and hundreds of billions are spent on service delivery programs.  However, relatively little is spent on, or known about, how best to ensure that the lessons learned from research inform and improve the quality of health and human services and the availability and utilization of evidence-based approaches.  The National Institutes of Health have recognized that closing the gap between research discovery and program delivery is both a complex challenge and an absolute necessity if we are to ensure that all populations benefit from the Nation’s investments in new scientific discoveries.

The National Institute of Mental Health (NIMH), the National Cancer Institute (NCI), the National Institute on Drug Abuse (NIDA), the National Institute on Deafness and Other Communication Disorders (NIDCD), the Office of Behavioral and Social Science Research (OBSSR), the National Institute of Nursing Research (NINR), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institute of Dental and Craniofacial Research (NIDCR), the National Heart, Lung, and Blood Institute (NHLBI), and the Office of Dietary Supplements (ODS) invite grant applications for research that will identify, develop, and refine effective and efficient  methods, structures, and strategies that test models to disseminate and implement research-tested health behavior change interventions and evidence-based prevention, early detection, diagnostic, treatment, and quality of life improvement  services into public health and clinical practice settings. The purpose of this dissemination and implementation research program announcement (PAR) is to support innovative approaches to identifying, understanding, and overcoming barriers to the adoption of evidence-based interventions that previous efficacy or effectiveness research has shown to be effective, but where adoption to date has been limited or significantly delayed.    

Most researchers who propose to develop and test disease control interventions either explicitly or implicitly intend to promote efficacious interventions to the broader population from which the efficacy study sample was drawn or the public health or clinical practice settings in which the intervention was originally tested. Thus, for many years, health researchers may have assumed that an intervention deemed efficacious within clinical or community-based trials would be easily transmitted to the field; evidence suggests that this has not been the case. Moreover, little is known about effective approaches to overcome barriers to adoption of evidence-based interventions.

Recent literature has underscored the importance of understanding the many factors that affect whether the public health or clinical practice communities will use a given intervention.  Invited research on dissemination will address how information about health promotion and care interventions are created, packaged, transmitted, and interpreted among a variety of important stakeholder groups.  Research on implementation will address the level to which health interventions can fit within real-world public health and clinical service systems. 

The goals of this PAR are to encourage trans-disciplinary teams of scientists and practice stakeholders to work together to develop and/or test conceptual models of dissemination and implementation that may be applicable across diverse practice settings, and design studies that will accurately assess the outcomes of dissemination and implementation efforts.

This PAR addresses priorities laid out in a number of reports including: Bridging Science and Service: A Report by the National Advisory Mental Health Council's Clinical Treatment and Services Research Workgroup (http://www.nimh.nih.gov/publicat/nimhbridge.pdf) ; Translating Behavioral Science into Action: A Report of the National Advisory Mental Health Council's Behavioral Science Workgroup (http://www.nimh.nih.gov/publicat/nimhtranslating.pdf); Designing for Dissemination Conference Summary Report (http://cancercontrol.cancer.gov/d4d/info.html#conferences); Diffusion and Dissemination of Evidence-based Cancer Control Interventions (http://www.ahcpr.gov/clinic/epcsums/canconsum.htm);

National Institute on Drug Abuse Blue Ribbon Task Force Report on Services Research
(http://www.drugabuse.gov/about/organization/nacda/HSRReport.pdf).

For additional resources on dissemination research please visit http://cancercontrol.cancer.gov/d4d.

For additional information on dissemination and implementation research in blood diseases, http://www.nhlbi.nih.gov/resources/docs/index.htm#blood, and for the reports on sickle cell disease, http://www.nhlbi.nih.gov/meetings/scdmtg/execsum.htm and http://www.nhlbi.nih.gov/meetings/workshops/conscd.htm, may be useful.

RESEARCH OBJECTIVES

Dissemination and implementation research intends to bridge the gap between public health, clinical research, and everyday practice by building a knowledge base about how health information, interventions, and new clinical practices are transmitted and translated for public health and health care service use in specific settings.  Unfortunately, there continues to be great variation in how these terms are used.  Dissemination and implementation have both been used to represent the complete process of bringing "evidence" into practice, originally defined as "diffusion."  While using the terms dissemination and implementation to cover such a wide area can be very helpful in facilitating discussion, it does not allow for the division of this very complex diffusion process into smaller, more easily addressed research questions that can develop a robust knowledge base.  We are inviting applications that will begin to break down the complexity of bridging research and practice.

For the purpose of this PAR, we make a distinction between "dissemination" and "implementation."

This distinction needs to be made because interventions developed in the context of efficacy and effectiveness trials are rarely transferable without adaptations to specific settings.  Therefore, research is needed to examine the process of transferring interventions into local settings, settings that may be similar to but also somewhat different from the ones in which the intervention was developed and tested.

Dissemination Research

We are currently missing critical information about how, when, by whom, and under what circumstances research evidence spreads throughout the agencies, organizations, and front line workers providing public health and clinical services.  As a necessary prerequisite for unpacking how information can lead to treatment or service changes, we need to understand how and why information on mental health, drug abuse, and other disease treatments may or may not reach many different stakeholders.  We need to understand what underlies the creation, transmission, and reception of information on evidence-based psychopharmacological, behavioral, and psychosocial interventions.  Successful dissemination of health information (including information about underutilized interventions) may occur quite differently depending on whether the audience consists of consumers, caregivers, practitioners, policymakers, employers, administrators, or other stakeholder groups.  Moving the field forward will require studies identifying mechanisms and approaches to package and convey the evidence-based information necessary to improve public health and clinical care services.

Implementation Research

Previous efforts in dissemination research have often assumed that interventions can be transferred into any service setting without modification and that a unidirectional flow of information (e.g., publishing a guideline) is sufficient to achieve practice change.  "Success" of the transfer has been largely assessed based on structural measures (such as counts of personnel or contacts) or patient outcome measures that do not specifically assess how the intervention was implemented or whether the implementation remained faithful to the original conceptualization and intent of the intervention.  We need the field to develop a knowledge base about "how" interventions are transported to real-world practice settings, which is likely to require more than the dissemination of information about the interventions.  This research announcement encourages theory-driven studies to test conceptual frameworks around the implementation process that move away from an exclusively "top-down" approach to a greater emphasis on the resources of local care settings and the needs of multiple stakeholders.

Dissemination and Implementation research need to involve both interdisciplinary cooperation and trans-disciplinary collaboration, utilizing theories, empirical findings, and methods from a variety of fields not traditionally associated with health research.  Relevant fields include:  information science, clinical decision-making, organizational and management theory, finance, individual and systems-level behavioral change, anthropology, learning theory, and marketing. Meaningful research will include collaboration with stakeholders from multiple public health and/or clinical practice settings as well as consumers of services and their families/social networks.

Research Issues:  Listed below are examples of topics supported by this program announcement for dissemination and implementation research.  The list is illustrative, not exhaustive.  It is expected that investigators responding to this PAR will identify other important research areas.

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

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the R01 award mechanism.

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

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

2. Funds Available

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

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

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

1.B. Eligible Individuals

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

2. Cost Sharing or Matching
 
Cost sharing is not required.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria
Not applicable

Section IV. Application and Submission Information

1. Address to Request Application Information

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

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

2. Content and Form of Application Submission

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

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

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

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

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

3.A. Receipt, Review and Anticipated Start Dates

Letters of Intent Receipt Date(s): 12/26/2005, 08/22/2006, 04/24/2007, 12/26/2008, 08/25/2008, 04/22/2009
Application Receipt Dates(s): 01/24/2006, 09/22/2006, 05/24/2007, 01/24/2008, 09/24/2008, 05/22/2009
Peer Review Date(s): 06/2006, 02/2007, 10/2007, 06/2008, 02/2009, 10/2009
Council Review Date(s): 09/2006, 05/2007, 1/2008, 09/2008, 05/2009, 01/2010
Earliest Anticipated Start Date: 12/2006, 07/2007, 04/2008, 12/2008, 07/2009, 04/2010  

3.A.1. Letter of Intent

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

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

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:
 
David Chambers, Ph.D.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Blvd., Room 7133
Bethesda, MD 20892-9631
Telephone: (301) 443-3747
Fax: (301) 443-3747
Email: dchamber@mail.nih.gov

3.B. Sending an Application to the NIH

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

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

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

3.C. Application Processing

Applications must be received on or before the application receipt/submission date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review.

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

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

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

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

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
 
Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
 
6. Other Submission Requirements

Specific Instructions for Modular Grant applications.

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

Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year.

Applicants requesting $500,000 or more in direct costs for any year must carry out the following steps:

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

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

3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.

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

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

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

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

Section V. Application Review Information

1. Criteria
Only the review criteria described below will be considered in the review process.
 
2. Review and Selection Process
 
Applications submitted for this funding opportunity will be assigned to the ICs on the basis of established PHS referral guidelines.

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

The 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, public health 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?  Do the intervention efficacy data justify dissemination and implementation? If the aims of the proposed project are achieved, how will dissemination and implementation knowledge be advanced? What will be the effect on the concepts or methods that drive this field?  Will the study have a clear positive impact on public health and community as well as clinical contexts? How broad a reach (to the population that will benefit from the knowledge/intervention) will be achieved by the dissemination and implementation of the intervention through the knowledge/service delivery contexts selected?

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?   Has the applicant made appropriate changes in the intervention design based on the current state-of-the-art and or contextual factors relevant to dissemination and/or implementation? Does the applicant demonstrate an understanding of dissemination and implementation research principles? Is the dissemination or implementation approach appropriate to the problem and population? Are the procedures to assess the dissemination or implementation program appropriate? Is the evaluation plan linked to the dissemination or implementation plan and does the evaluation incorporate the best available data to track dissemination or implementation process and impact? How appropriate are the plans to sustain effective dissemination and implementation approaches once the research-funding period has ended?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms, public health 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?  Does the proposed dissemination or implementation research contribute new and innovative design approaches to the study of dissemination or implementation process and/or outcomes?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? Does the investigator team include specific dissemination and implementation expertise? Relevant letters of support from key partner dissemination and implementation organizations, which plan to adopt the intervention, are expected.

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? Do the proposed approaches take advantage of unique features of the intervention delivery environment or employ useful, collaborative arrangements? Is there evidence of institutional support to sustain dissemination or implementation interventions once the research funding ends?

2.A. Additional Review Criteria:

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

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

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

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

2.B. Additional Review Considerations

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

2.C. Sharing Research Data
 
Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data 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 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/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

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

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

3. Anticipated Announcement and Award Dates
Not applicable

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

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

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

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of Award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

3. Reporting

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

Section VII. Agency Contacts

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

1. Scientific/Research Contacts:

David A. Chambers, Ph.D.
Division of Services and Intervention Research
National Institute of Mental Health
Neuroscience Center, Room 7133 MSC-9631
Bethesda, MD  20892-9631
Telephone: (301) 443-3747
FAX: (301) 443-4045
Email: dchamber@mail.nih.gov

Chris Gordon, Ph.D.
Division of AIDS and Health and Behavior Research
National Institute of Mental Health
Neuroscience Center, Room 6199 MSC-9619
Bethesda, MD  20892-9619
Telephone:  (301) 443-1613
FAX:  (301) 443-9719
Email:  cgordon1@mail.nih.gov

Jon F. Kerner, Ph.D.
Division of Cancer Control & Population Sciences
National Cancer Institute
EPN 6144
6130 Executive Blvd.
Bethesda, MD 20892
Telephone: (301) 594-7294
FAX: (301) 443-4505
Email: kernerj@mail.nih.gov

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: rchandle@nida.nih.gov

Amy Donahue, Ph.D.
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 400C-10
Bethesda, MD 20892
Telephone: (301) 402-3458
Fax:  (301) 402-6251
Email: donahuea@nidcd.nih.gov

Susan D. Solomon, Ph.D.
Senior Advisor
Office of Behavioral and Social Sciences Research
National Institutes of Health, Office of the Director
Building One, Room 256, NIH
One Center Drive
Bethesda, MD 20892-0183
Telephone: (301) 496-0979
Fax: (301) 402-1150
E-mail: SSolomon@NIH.Gov

Martha L. Hare, Ph.D., R.N
Program Director
NIH/National Institute of Nursing Research
6701 Democracy Boulevard
One Democracy Plaza, Room 710
Bethesda, MD  20892-4870 Courier: 20817
Telephone: (301) 451-3874
Fax: (301) 480-8260
Email: Martha.hare@nih.gov

Peter J. Delany, Ph.D.
Program Director for Health Services Research
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health
5635 Fishers Lane, Rm 2039
Bethesda, MD 20892-9304
Telephone: (301) 443-0788
Fax: (301) 443-8774
Email: delanyp@mail.nih.gov

Patricia Bryant, Ph.D.
Division of Extramural Research
National Institute of Dental and Craniofacial Research
Building 45, Room 4AN-24E
Telephone:  301/594-2095
Fax:  301/480-8318
E-mail:  bryantp@de45.nidr.nih.gov

Lawrence J. Fine M.D., Dr.P.H.
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
6701 Rockledge Dr. , Room 8138, MSC-7936
Bethesda MD 20892-7936
Telephone: (301) 435-0305
Fax: (301) 480-1669
Email: Finel@nhlbi.nih.gov

Elizabeth A. Yetley, Ph.D.
Senior Nutrition Research Scientist
Office of Dietary Supplements
National Institutes of Health
6100 Executive Boulevard, Suite 3B01
Bethesda MD 20892-7517Telephone:  (301) 496-0217
Fax:  (301) 480-1845
Email: yetleye@od.nih.gov

2. Peer Review Contacts:

Steven H. Krosnick, M.D.
SRA, Health of the Population (HOP) Integrated Review Group
Center for Scientific Review (CSR), NIH
6701 Rockledge Drive, Room 3028A, MSC 7770
Bethesda, MD 20892 (20817 for overnight mail)
301-435-1712
301-480-1056 (fax)
Email: Krosnics@mail.nih.gov

3. Financial or Grants Management Contacts:

Joy R. Knipple
Grants Management Branch
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6131 MSC 9605
Bethesda, MD  20892-9605
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 443-8811
FAX:  (301) 443-6885
Email: jk173r@nih.gov

Crystal Wolfrey
Grants Management Branch
Division of Extramural Activities
National Cancer Institute
6120 Executive Blvd, EPS 243
Bethesda, MD, @0892
Telephone: (301) 496-8634
FAX: (301) 496-8601
Email: wolfreyc@mail.nih.gov

Gary Fleming, J.D., M.A.
National Institute on Drug Abuse
Office of Planning and Resource Management
Grants Management Branch
6001 Executive Boulevard, Room 3131 MSC 9541
Bethesda, MD 20892-9541
Phone: 301-443-6710
Fax: 301-594-6847
E-mail: gfleming@mail.nih.gov

Christopher Myers
National Institute on Deafness and Other Communication Disorders
Grants Management Branch
6120 Executive Blvd., EPS Room 400B
Bethesda, MD 20892
Phone: 301 435 0713 
Fax: 301 402 1758
Email: Myersc@mail.nih.gov

Brian Albertini
Chief, Office of Grants and Contracts Management
National Institute of Nursing Research
National Institutes of Health
6701 Democracy Blvd, Room 710
One Democracy Plaza
Bethesda, MD 20892-4870 (Courier use 20817)
Telephone: (301) 594-6869
Fax: (301) 402-4502
Email: Albertib2@nih.mail.gov

Judy S. Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3021
Bethesda, MD 20892-9304
Telephone: (301) 443-4704
FAX: 301-443-3891
Email: jfox@mail.nih.gov

Mary E. Daley
National Institute of Dental and Craniofacial Research
45 Center Dr MSC 6402
Bethesda, MD 20892-6402
Phone: 301-594-4800
Fax: 301-480-8303
E-mail: md74u@nih.gov

Teresa Farris Marquette
Section Chief
Grants Operations Branch
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7152 , MSC 7926
Bethesda, MD  20892-7926
Telephone: (301) 435-0172
Fax:  (301) 480-3310
Email: tm275a@nih.gov

Section VIII. Other Information

Required Federal Citations

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

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

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

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

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.
 
Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

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

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

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
 
NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

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

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

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

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

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

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

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

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

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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