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 Cancer Institute (NCI) (http://www.cancer.gov)

Title: State and Community Tobacco Control Policy and Media Research (U01)

Announcement Type
New

Request For Applications (RFA) Number: RFA-CA-10-008

Catalog of Federal Domestic Assistance Number(s)
93.393, 93.399

Key Dates
Release Date:  November 6, 2009
Letters of Intent Receipt Date: December 22, 2009
Application Receipt Date: January 22, 2010
Peer Review Date: March/April 2010
Council Review Date: August 2010
Earliest Anticipated Start Date: September 2010
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: January 23, 2010

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(s) 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. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt, Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
    D. Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

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

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
     A. Cooperative Agreement Terms and Conditions of Award
         1. Principal Investigator Rights and Responsibilities
         2. NIH Responsibilities
         3. Collaborative Responsibilities
         4. Arbitration Process
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

Purpose

This funding opportunity announcement (FOA) solicits applications for research projects that address important under-studied aspects of State and community tobacco control policy and media interventions. Focal areas include secondhand smoke policies, tax and pricing policies, tobacco industry marketing and promotion, mass media countermeasures, and community and social norms. NCI expects to support both observational and intervention studies that address tobacco use and exposure in any form in the United States (U.S.).

This FOA also solicits applications for a cooperative agreement to establish a Coordinating Center for this program. The primary mission of the Coordinating Center will be to provide the necessary scientific leadership and organizational and administrative structure to facilitate interactive and integrative collaboration and communication among the awardees of individual research projects funded by this initiative as well as between the awardees and the NCI.

Background

Although significant progress has been made in reducing tobacco use in the U.S., many challenges remain. Approximately one in five adults (21%) - 45 million Americans, are current cigarette smokers. Significant disparities in smoking prevalence exist, based on income, education, race/ethnicity and other factors. Recent data indicate that progress in reducing smoking prevalence among youth and adults may have stalled. Additionally, exposure to secondhand smoke is still common risk, particularly in certain subpopulations, including, children, non-Hispanic Blacks, and people with low income. Anti-tobacco community and social norms against smoking are not equally distributed across populations. There are significant knowledge gaps about how best to strengthen and reinforce anti-tobacco social norms across diverse communities, and counteract competing pro-tobacco social norms. The environment also features a changing landscape of tobacco products, evolving tobacco industry marketing and promotion strategies, and new and emerging technologies and media channels. To ensure that tobacco use in the U.S. continues to decline, innovative research at the State and community levels is needed to identify the most effective tobacco control policies and media interventions for diverse populations, and to better understand the tobacco companies’ continuing efforts to promote tobacco use.

Historically, States and communities have played an important role in implementing tobacco prevention and control policies and programs, and designing and implementing mass media campaigns. States and communities are ideal laboratories to: test policies; identify the policies or combination of policies, programs, and media messages that most affect tobacco prevalence and consumption; and disseminate research findings among diverse populations. Research funded through this FOA is expected to have immediate utility for State and community tobacco control programs and practitioners.

NCI seeks to fund observational and intervention studies that examine one or more of the following research areas: (1) secondhand smoke policies; (2) tobacco excise tax and pricing policies; (3) mass media countermeasures and community and social norms; and (4) tobacco industry practices as they relate to these other three areas.

Secondhand Smoke Policies

Smoke-free policies have been shown to reduce nonsmokers’ exposure to secondhand smoke, to promote a non-smoking norm, and to assist smokers to successfully quit. However, many adults remain exposed to secondhand smoke in workplaces, homes, and public places. Children are especially likely to be exposed to secondhand smoke in private locations such as homes (including multi-unit housing complexes) and cars. Research is needed to explore the effects of expanding, implementing, and enforcing smoke-free policies in private settings such as cars and homes, including multi-unit housing and outdoor public venues such as concerts, sporting events, and outdoor seating areas of restaurants.

Research is needed, for example, to understand:

Tobacco Excise Tax and Pricing Policies

Increasing tobacco excise taxes and, thus, tobacco product cost, is an effective strategy for reducing smoking prevalence and consumption. However, little is known about unintended consequences (helpful and harmful) and threshold effects of price increases, and how tobacco company discounts and promotions and illegal sales impact prevalence and consumption rates among various populations.

Research is needed, for example, to understand:

Other research needs include examining the duration of effects of a tax increase, factors that most contribute to the erosion of tax increases, and possible threshold effects in tax increases.

Mass Media

Tobacco industry mass media advertising and promotion have played a significant role in increasing tobacco use rates and smoking-related morbidity and mortality. Adolescents are increasingly exposed to movie images of smoking. Older, male, and Black children are significantly more likely to be exposed to movie images of smoking than other children.

However, media campaigns designed to counter tobacco use and restrictions on tobacco advertising and promotion have also contributed to substantial declines in smoking rates. Effective media campaigns that reach those most at risk for initiating or continuing tobacco use must be designed and conducted.

Research is needed, for example, to understand:

Tobacco company practices in relationship to secondhand smoke policies, tobacco excise tax and pricing policies, and mass media.

Historically, the tobacco industry has worked in opposition to evidence-based tobacco prevention and control policies, including secondhand smoke, and tobacco excise tax and pricing policies. Additionally, cigarettes are one of the most heavily marketed products in the U.S., depictions of cigarette smoking in the movies are pervasive, and causal relationships exist between tobacco advertising and promotion and increased tobacco use, and exposure to depictions of smoking in movies and youth smoking initiation. As new public health focused programs and policies are developed in the areas of secondhand smoke policies, and tobacco excise tax and pricing policies, one may reasonably expect that the tobacco industry will evolve strategies in opposition. Similarly, as research determines new mass media strategies to promote nonsmoking norms in diverse communities, these may be countered by tobacco industry efforts. Therefore, research is needed to elucidate the nature of tobacco company strategies and behaviors particularly as they relate to the areas of secondhand smoke, tax and pricing policies, and mass media.

Additionally, tobacco companies have sponsored sports, arts, and entertainment events and contributed to community organizations and social causes. Research is needed to determine how tobacco company sponsorship policies and practices affect the discrete aspects related to tobacco use (initiation, consumption, cessation, and relapse) and corresponding prevalence rates among various populations. The impact of the public relations efforts and social responsibility programs sponsored by the tobacco industry also needs to be studied, as well as evidence-based strategies to counteract these efforts.

Specific Requirements and Research Objectives of this FOA

Part A. Objectives and Requirements for Research Project Applications

Research Projects applications proposed in response to this FOA must address high priority questions regarding tobacco control policy and media interventions. Plans to facilitate swift adoption and implementation of the anticipated research findings must also be described. For these overall goals, Research Project applicants are strongly encouraged to work collaboratively with state and/or local public health and tobacco control programs. As appropriate for specific projects, applicants are expected to form partnerships with community-based organizations and agencies to facilitate their research. These partnerships and collaborations should begin very early in the process of developing grant applications to increase the likelihood of true dialogue occurring and ensure that community-based organizations and agencies have input into the specific research aims. The goal of this type of proactive collaboration is to facilitate the design of research projects that address the needs of their States and communities in ways that have the greatest likelihood of improving the public’s health.

Each application should include a comprehensive proposal articulating the applicant’s or applicants’ plans to proactively disseminate research findings broadly to all interested parties in a timely fashion.

Potential research topics include, but are not limited to, the following:

JOINT RESEARCH PROJECTS. In addition to conducting individual projects, each Research Project awardee will be expected to participate in collaborative pilot, exploratory projects conducted jointly by several (or all) program awardees. Applicants should not propose specific pilot projects but are encouraged to describe their vision how such projects may be solicited, assessed, and prioritized.

RESULTS DISSEMINATION. For this research initiative to be fully successful, research findings must be translated and disseminated to a wide array of audiences, including tobacco control programs; public health practitioners; researchers; parents and teachers; youth and youth-serving organizations; Federal, State, and local policy makers; and the general public. For this reason, applicants must propose plans for dissemination of the anticipated research findings and identify how any proposed interventions will be proactively disseminated.

NON-RESPONSIVE: Animal studies and any other non-human laboratory studies are not responsive to this FOA (human laboratory studies are responsive).

Part B. Objectives and Requirements for Coordinating Center Applications

The primary mission of the Coordinating Center will be to provide scientific and organizational leadership necessary to facilitate interactive and integrative collaboration and communication of the research projects funded by this initiative. The Coordinating Center will help facilitate all scientific and research coordination, evaluation, dissemination, and research project coordination and communications among the four to six research projects and NCI staff.

The specific responsibilities of the Coordinating Center for the State and Community Tobacco Control Policy and Media Research FOA are listed. These tasks will be completed in close coordination and communication with the Steering Committee, the NCI Scientific Coordinator and the NCI Project Scientists. See Section VI.2.A. Cooperative Agreement Terms and Conditions of Award for a more information about these roles.

Coordinating Center applicants must describe their plans for various specific aspects outlined below:

Scientific and Research Coordination

Evaluation

Dissemination

Research Project Coordination and Communication

Coordinating Center Budget/Considerations:

Total costs will not exceed $2,000,000 per year for the Coordinating Center.

Part C. Administrative Structure of the Program and Integration of Research Projects.

The Steering Committee will be the governing body for all awardees funded under this FOA. The Steering Committee will include representatives of individual Research Project, Coordinating Center, and the NCI. The Steering Committee will also facilitate close interactions among individual Research Project awardees and the overall coordination of the program efforts by the Coordinating Center.

For specific rights and responsibilities of the awardees and the details on the Steering Committee, see Section VI. 2.A. Cooperative Agreement Terms and Conditions of Award.

Investigator Meetings. Investigator meetings will be convened twice a year throughout the project period to consider, as appropriate, common data elements, cross-site projects, developmental projects, and dissemination of research findings. The meetings will also provide the opportunity for the investigators to share scientific information and data, assess scientific progress, identify new research opportunities, and foster interactions between new and established tobacco control researchers.

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

Section II. Award Information


1. Mechanism of Support

This funding opportunity will have two specific components that will each use the U01 award mechanism. NCI staff anticipates funding one U01 award to a Coordinating Center and four to six individual U01 Research Projects.

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

This funding opportunity will use a cooperative agreement award mechanism (U01). In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award."  

2. Funds Available

The NCI expects to commit approximately $12 million in Fiscal Year 2010 to fund approximately four to six Research Projects and one Coordinating Center. Future year amounts will depend on annual appropriations.

Research Project applicants may request a project period of up to 5 years at budget of up to $1.6 million (total costs) for the first year. A 3% escalation for cost of living on future year budgets is allowed. On the top of that, applicants must budget $200,000 in total costs per year beginning in the second budget year for cross-site collaborative developmental or exploratory projects, including projects that take advantage of emerging tobacco control issues.  These projects will be decided by the Steering Committee in consultation with NCI staff members. NCI staff will retain ultimate authority over decisions allocating these funds.

Coordinating Center applicants may request a project period of up to 5 years at a budget of up to $2 million (total costs) for the first year. A 3% escalation for cost of living on future year budgets is allowed.

Because the nature and scope of the proposed research will vary from application to application, NCI staff members anticipate that the size and duration of each award will also vary. Although the financial plans of the NCI 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.

NIH grants policies as described in the http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

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

Individual institutions are eligible to apply for both the Coordinating Center and the individual Research Projects. However, PDs/PIs who apply for the Coordinating Center award may NOT also apply as PDs/Ps for a Research Project award. Similarly, PDs/PIs and research teams who apply for a Research Project award may not also apply as PDs/PIs for the Coordinating Center award.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

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

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

Number of Applications. Applicant institutions may submit more than one application for individual research project awards, provided each application is scientifically distinct and submitted by different teams (as defined under Section 1.B. Eligible Individuals above).

Only one application per institution is allowed in case of applications for coordinating center award. Such application may be in addition to an application(s) for research project awards from the same institution (but must be submitted by different PDs/PIs and research teams.

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 in Item (box) 2 only of the face page of the application form and the YES box must be checked.

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

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

Applications from foreign organizations must:

In addition, for applications from foreign organizations:

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

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs  

When multiple PD/PIs are proposed, use the Face Page-Continued page to provide Items 3a – 3h for all PD/PIs. NIH requires one PD/PI be designated as the “contact PD/PI” for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the “Contact PD/PI, et. al.”  The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as the Signing Official [SO] or Peer Reviewer in the NIH Internet-Assisted Review [IAR] will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

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

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

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

Additional information is available in the PHS 398 grant application instructions.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times: Not Applicable.

3.A. Receipt, Review, and Anticipated Start Dates
Letters of Intent Receipt Date: December 22, 2009
Application Receipt Date: January 22, 2010
Peer Review Date: March/April 2010
Council Review Date: August 2010
Earliest Anticipated Start Date: September 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 NCI staff to estimate the potential review workload and better plan the review.

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

The letter of intent should be sent to:

Yvonne Grant
Program Director
Behavioral Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Boulevard, MSC 7337
Executive Plaza North, Room 4056
Bethesda, Maryland 20892‑7337 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
(301) 435-2838
(301) 435-7547 (FAX)
Email: granty@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the 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 three 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 (for U.S. Postal Service express or regular mail)
Bethesda, MD 20817 (for non-USPS delivery)

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

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: ncirefof@dea.nci.nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the NIH Center for Scientific Review staff and for responsiveness by the NCI. Incomplete and/or non-responsive 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 review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at https://commons.era.nih.gov/commons/.

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 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: 1) are necessary to conduct the project; and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new 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 at http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

6. Other Submission Requirements

Special Instructions for Preparation of Research Projects and Coordinating Center Applications

Part A. Instructions for the Preparation of RESEARCH PLAN for Research Project Applications

The standard PHS398 instructions for Research Plan are altered as follows:

Applicants will specifically address how they will fulfill the responsibilities articulated in the Rights and Responsibilities of the Research Project Awardees Section of this FOA.

Section A1 - Collaborations

Applicants must identify their plans to collaborate with state or local tobacco control programs or other public health organizations as identified in this FOA. The collaborative requirements are integral to this initiative.  Therefore, applicants must highlight, whenever possible, the collaborative component in the study with justifications as to why collaboration is needed and how working with other tobacco control programs or public health organizations would add value to their proposed study. Applicants should describe their plans for any future collaboration, including which organizations with whom they will collaborate and the nature of these activities.

It is anticipated that efforts will be made to foster collaborative research among the recipients of grants under this FOA. For example, awardees that are testing the impact of similar interventions, or focusing on similar populations, will be encouraged to undertake collaborative research activities. Potential collaborations may include examining measurement issues, assessing complex interventions through different designs, assessing the impact of “contamination,” or monitoring the responses of the tobacco industry to new interventions. Investigators will also be asked to consider the collection of common data elements.

Section A2 - Dissemination

Applicants must clearly articulate their plans to proactively disseminate their research findings to a broad range of interested parties to ensure maximum public health impact.

Section A3 - Compliance with terms and conditions of award for Cooperative Agreement

Applicants must include their specific plans for meeting the requirements defined by the "Cooperative Agreement Terms and Conditions of Award" section of this FOA. In particular:

a)     Applicants must plan for collaborating and sharing data freely with the other initiative components, participating in planning and attending workshops and symposia, serving on the Steering Committee and abiding by Steering Committee decisions. Applicants are expected to participate in collaborative projects within their research project and across projects.

b)    Applicants must be able and willing to share data and research resources with each other and the NCI.

Part B. Instructions for the Preparation of RESEARCH PLAN for Coordinating Center Applications

The standard PHS398  instructions for Research Plan are altered as follows:

Applicants will specifically address how they will fulfill the responsibilities articulated in the Rights and Responsibilities of the Research Project Awardees Section of this FOA.

Coordinating Center applicants should demonstrate their innovative ideas to significantly advance the field through working with new partners to proactively implement evidence-based behavior change strategies and policies that support these strategies.  Overall, the proposed Coordinating Center must have a clear focus on the main goal of the initiative and aims to maximize its public health impact by significantly reducing tobacco use.

Section A1 –Coordination

Coordinating Center applicants need to identify the specific methods they propose to use to coordinate the funded Research Projects. The plans should include emphasis on synergy and opportunities for collaborative research projects.

The coordination requirements are integral to this initiative. Applications will be judged for their scientific merit as well as the innovativeness and feasibility of their plans to coordinate among Research Projects.

Section A2 - Dissemination

Applicants must clearly articulate their plans to proactively disseminate their research findings to a broad range of interested parties to ensure maximum public health impact. Coordinating Center applicants should address how they will coordinate dissemination efforts for the entire initiative and propose innovative opportunities for proactive dissemination, including potential organizations with whom to collaborate.

Section A3 - Compliance with terms and conditions of award for Cooperative Agreement

Applicants must include their specific plans for meeting the requirements defined by the "Cooperative Agreement Terms and Conditions of Award" section. In particular, applicants must confirm their willingness and ability to:

a)     collaborate and share data freely with the other initiative components

b)    participate in planning and attending workshops and symposia;

c)     serve on the Steering Committee and be bound by its decisions;

d)    participate in collaborative projects within their research project and across projects; and

e)     share data and research resources with each other and the NCI.

Section A4 - Organization of Coordinating Center tasks and interactions with Steering Committee.

Applicants must include their specific plans to fulfill the responsibilities of the Coordinating Center as outlined in this FOA. In addition, they should identify how they: will interact with the Steering Committee; and how they propose to communicate with the Steering Committee and NCI staff; and will facilitate and coordinate communication across the initiative.

Additional budget-related Information

Beginning in the second budget year, each research project application must include $200,000 in total costs per year for cross-site collaborative developmental or exploratory projects, including projects that take advantage of emerging tobacco control issues. These projects will be decided by the Steering Committee in consultation with NCI staff members. NCI staff will retain ultimate authority over decisions allocating these funds.

Both Research Project applicants and Coordinating Center applicants must budget appropriate funds to support travel of up to three investigators (e.g., PD/PI and two senior investigators) to the Investigator Meetings. Investigator meetings will be convened twice per year throughout the project to consider, as appropriate, common data elements, cross-site projects, developmental projects, and dissemination of research findings. The meetings will also provide the opportunity to share scientific information and data, assess scientific progress, identify new research opportunities and foster interaction between new and established tobacco control researchers. Support for travel by the Principal Investigator and two co‑investigators should be included in the proposed budget. For purposes of budget planning, two 2-day meetings each year are anticipated, one to be held in the Washington, DC, area and one on the West Coast of the U.S. The first meeting will occur in the Washington, DC, area within 6 months from making the awards.

Appendix Materials

All paper PHS 398 applications must provide appendix material on CD only, and include five identical CDs in the same package with the application (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html).

Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information, see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Specific Instructions for Foreign Applications

All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.

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

Review Process

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

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

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

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

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

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

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

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

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

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

In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the impact/priority score.

A. Additional Criteria for Research Projects Applications

Collaboration

Dissemination

B. Additional Criteria for Coordinating Center Applications

Coordination

Dissemination

Additional Review Criteria 

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

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

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

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

Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

Additional Review Considerations

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

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

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

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

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

Selection Process

The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

Not applicable

Section VI. Award Administration Information


1. Award Notices

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

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (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 NoA. 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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

These Terms and Conditions of Award apply to the organizational structure to be funded through this FOA and which will be composed of the Coordinating Center and individual Research Projects awards. All the awardee institutions agree to collaborate on the research goals of this Program as defined in the FOA.

2. A.1. Awardee and Principal Investigator Rights and Responsibilities

Rights and Responsibilities of the Research Project Awardees and PDs/PIs

The PDs/PIs of individual research project awards will have the primary authority and responsibility for:

Rights and Responsibilities of the Coordinating Center Awardee and PD(s)/PI(s)

The PD(s)/PI(s) of the Coordinating Center will have the primary responsibility for:

2. A.2. NIH Responsibilities

Several NCI staff members will have substantial programmatic involvement that is above and beyond the normal stewardship role in the cooperative agreements resulting from this initiative. The designated NCI Program Directors will serve as Project Coordinator and Project Scientist(s). The Project Coordinator will have primary responsibility for coordinating the overall program. The Project Scientists will be the primary NCI resource for the Awardees in terms of all scientific issues related to individual research projects and the Coordinating Center. Project Coordinator may also serve as a Project Scientist.

The NCI Tobacco Control Research Branch Chief may serve as needed as a Project Coordinator.

Specific responsibilities of substantially involved NCI Program Staff Members will include the following:

NCI Program Coordinator will have the following responsibilities reflecting substantial scientific-programmatic involvement:

NCI Project Scientists will have the following responsibilities reflecting substantial scientific-programmatic involvement::

The NCI Project Coordinator, Project Scientists as well as other substantially involved NCI staff members will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications. If such participation is essential, the substantially involved individuals will seek NCI waiver according to NCI procedures for management of conflict of interest.

Additionally, an NCI Program Director, acting as Program Official, will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The Program Official will be the primary NCI point-of-contact with all the Awardees on numerous administrative matters pertaining to these awards. If the NCI Program Official serves also as a Project Scientist/Coordinator, the individual involved will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications or will seek NCI waiver as stated above.

2.A.3. Collaborative Responsibilities

Steering Committee

Roles. The Steering Committee will be the main governing body for this initiative and will provide input on scientific matters. The Steering Committee members will provide scientific, statistical, and technical input into discussions of pooled and collaborative research projects where relevant.

The Steering Committee, in partnership with NCI Program Staff members, will monitor the progress of these projects, facilitate common data sharing, evaluation, and group publications. The Steering Committee will evaluate the merit of all proposed cross-site developmental projects and identify common resources to support such efforts.

Composition. The Steering Committee for this initiative will consist of the following voting members:

A Chairperson of the Steering Committee must be either Coordinating Center PD/PI or a Research Project PD/PI.

All Awardees will be required to accept and implement policies approved by the Steering Committee to the extent of corresponding grant regulations.

NCI staff will maintain authority on all matters regarding funding or expenditure of funds.

Subcommittees. The Steering Committee may establish subcommittees or task forces to provide input on specific matters as needed. The NCI Project Scientists/Coordinators will serve on subcommittees or task forces, as they deem appropriate. Subcommittees or task forces may also include other representatives from NCI as non-voting members of the Steering Committee. The Steering Committee may invite additional, non-voting scientific advisors to the meetings. The NCI reserves the right to augment the scientific or consumer expertise of the Steering Committee as it deems necessary.

Meetings. The Steering Committee will meet in person twice each year at locations selected by the Steering Committee in consultation with the NCI as part of the semi-annual Investigators Meetings. In addition, the Steering Committee will meet regularly by conference call. The PD/PI of the Coordinating Center, and the PD/PI, and a senior investigator from each Research Project must attend every in-person meeting of the Steering Committee, and the PD/PI or a senior investigator from each research project award must participate in all conference calls as appropriate. Centers may budget travel support for the PD/PI and up to two project co-investigators to attend the biannual grantee meetings. The Steering Committee may invite additional individuals to participate at the semi-annual Investigators Meetings.

2.A.4. Dispute Resolution

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. A Dispute Resolution Panel will be convened, having three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

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

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

Section VII. Agency Contacts


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

1. Scientific/Research Contacts:

Bob Vollinger, M.S.P.H.
Tobacco Control Research Branch
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Boulevard, MSC 7337
Executive Plaza North, Room 4030
Bethesda, Maryland 20892‑7337 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Phone:  301‑496‑8584
Fax:  301‑496‑8675
E‑mail:  Bob.Vollinger@nih.gov

2. Peer Review Contacts:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: ncirefof@dea.nci.nih.gov

3. Financial or Grants Management Contacts:

Crystal Wolfrey
Team Leader, Biology & Population Sciences Section
Office of Grants Administration
National Cancer Institute
National Institutes of Health
6120 Executive Blvd., Suite 243
Bethesda, MD 20892 (for regular mail)
Rockville, MD 20852 (for hand delivered mail)
Phone:  (301) 496-8634
Fax:  (301) 496-8601

Section VIII. Other Information


Required Federal Citations

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

Human Subjects Protection:
Federal regulations (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.

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

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/archive/archive/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 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.

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-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award. For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (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. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for 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 FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

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


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