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 Heart, Lung, and Blood Institute (NHLBI), (http:/www.nhlbi.nih.gov)  
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov)
National Cancer Institute (NCI), (http://www.nci.nih.gov)

Title:  Effectiveness Research on Smoking Cessation in Hospitalized Patients (U01)

Announcement Type
New

Request for Applications (RFA) Number: RFA-HL-10-020

Catalog of Federal Domestic Assistance Number(s)
93.837, 93.838, 93.279, 93.399

Key Dates
Release/Posted Date: November 16, 2009
Letters of Intent Receipt Date: December 18, 2009
Application Due Date:  January 19, 2010
Peer Review Date: June 2010
Council Review Date: August 2010
Earliest Anticipated Start Date: January 2011
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: January 20, 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 of Support

2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants

    A. Eligible Institutions
    B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information

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

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

Section VI. Award Administration Information
1. Award Notices

2. Administrative and National Policy Requirements
     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 Contacts
1. Scientific/Research Contact(s)

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Background

Despite considerable advances in tobacco control, smoking remains the leading preventable cause of premature death in the United States. Nearly one-third of all cancer deaths are caused by smoking, including 87% of lung cancer deaths and most cancers of the larynx, oral cavity and pharynx, esophagus and bladder.  Smoking greatly accelerates lung function decline, significantly increases the risk of coronary artery disease, accelerates the development of atherosclerotic vascular diseases, and increases the risk of acute coronary events, including sudden cardiac death. Smoking increases the risk of acute myocardial infarction (MI) threefold across all age groups, and fivefold in those under 50 years of age.  Fortunately, smoking cessation, even in patients already diagnosed with smoking-attributable illnesses, reduces the risk of medical complications and premature death.  Cancer survivors who smoke may have more progressive disease, increased morbidity and treatment complications, and lower treatment survival rates. Among smokers with coronary heart disease, those who quit smoking reduce their relative risk of mortality by over a third, and reduce their risk of sudden cardiac death to the risk of those who never smoke. Patients with mild to moderate lung function impairment who quit smoking for five years reduce the decline in lung function comparable to those who never smoked.       

Hospitalization provides unique cessation opportunities for patients who smokeSmoking-related illnesses often contribute to the reason for hospitalization, providing a salient motivation to quit.  Hospitalization also provides a trial of abstinence removed from most environmental smoking cues, and the availability of a healthcare team that can assist in cessation efforts.  In part because of the opportunity that hospitalization provides for smoking cessation efforts, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and the Centers for Medicare and Medicaid (CMS) now require reporting on the proportion of current or past year smokers who receive counseling or medications for smoking cessation during a hospitalization for acute myocardial infarction (MI), congestive heart failure (CHF), or pneumonia.  A recent Cochrane review showed that smoking cessation counseling during hospitalization that includes supportive contacts for at least one month post-discharge increases the odds of quitting by 65% compared to hospitalization alone.  This review also illustrated the wide range of patients and cessation interventions studied (type, intensity, provider) which may contribute to a lack of clarity on how best to implement effective cessation programs for hospitalized smokers. 

Purpose

This FOA seeks to encourage research that (a) determines how to translate efficacious smoking cessation programs into effective programs for hospitalized smokers that can be widely implemented in routine clinical practice, and (b) assesses the cost-effectiveness of these interventions.  It is anticipated that the results of the projects supported by this FOA will provide hospital administrators, health policy makers, and healthcare providers with the scientific basis to implement effective smoking cessation programs initiated during hospitalization.  This scientific basis includes the identification and comparative effectiveness of interventions to optimize long-term cessation rates among hospitalized smokers, the efficacy of dissemination and implementation strategies that encourage wide adoption while maintaining treatment fidelity, and the generation of cost-effectiveness data to determine the financial value of these cessation interventions to the patient, healthcare system, and society.   

Applications in response to this FOA may utilize a variety of randomized controlled trial designs including randomization by patient, ward, or hospital or a variety of rigorous quasi-experimental or large distributive data network designs that address the impact of smoking cessation programs initiated during hospitalization.  Regardless of design, obtaining cost-effectiveness data is requiredQuality of care standards currently focus on those admitted for acute MI, CHF, or pneumonia, and cessation outcomes for those admitted with cardiovascular disease appear to be better than those admitted for other diseases, so studies are required to include patients admitted for cardiovascular and pulmonary conditions in sufficient numbers to perform subsample analyses comparing patients admitted for these conditions versus those admitted for other reasons. Widespread adoption of hospital-based cessation programs, however, will necessitate applicability across a range of admission diagnoses.  Therefore, target populations for projects responding to this FOA should include smokers hospitalized for any cause.  Projects with sufficient power to detect possible moderator effects of demographics and admission diagnoses on smoking cessation are encouraged. 

Smoking cessation interventions considered may include the range of efficacious pharmacologic and behavioral smoking cessation interventions and/or combinations of these interventions.  In addition to content, the intensity, timing, and duration of these interventions also may be evaluated, particularly during the post-discharge period of the intervention.  In determining the interventions to be evaluated, applicants are strongly encouraged to consider not only the theoretical and empirical bases for the interventions proposed but also how these interventions will be disseminated, implemented, and sustained in the healthcare delivery system.  Studies addressing the mode of intervention delivery are also encouraged, including evaluation of the qualifications of the clinical staff, the training/supervision required to deliver the intervention with fidelity, and in- person vs. remote support utilizing communications technologies, particularly post-discharge.  Regardless of mode of delivery, applicants are required to use existing healthcare staff as interventionists, not research staff added to the healthcare delivery system to deliver these interventions.  Biochemically-validated smoking abstinence of one year or more is expected to be the primary outcome measure in the proposed projects, but assessment of additional outcomes, particularly those related to cost-effectiveness such as rates of hospital readmission, medical care post-discharge, and other medical outcome measures should also be included

Research topics responsive to this FOA include but are not limited to those listed below:

Awardees of this FOA are expected to collaborate with other awardees and with the RCU on dissemination of study findings and on facilitating implementation of study findings in clinical practice.  In addition to publishing study specific findings in scientific peer-review journals and presenting these findings at national and international scientific conferences, awardees are expected to collaborate with other PRS awardees and the RCU on presenting and publishing aggregated data from all of the PRSs in the network.  Awardees are also expected to make their individual datasets and aggregated datasets available for data sharing to other investigators when appropriate.  Awardees are expected to coordinate efforts with each other and the RCU to collaborate with NHLBI, other participating NIH institutes, professional associations, and other agencies to promote the dissemination and implementation of successful research outcomes into clinical practice.

Program Organization and Coordination

Awardees are expected to plan, direct, and execute their own studies and conduct their own data management and statistical analyses, but should indicate their willingness to collaborate with the other awardees of this FOA on the development and use of standardized measures, methods, and data management whenever feasible.  To facilitate coordination of research activities between awardees of this cooperative agreement, a companion FOA (RFA-HL-10-025) solicits applications for a Research Coordinating Unit (RCU).  Cross-study coordination will be governed by a steering committee consisting of the principal investigators of this FOA, the principal investigator of the RCU, and the Program Scientists from NHLBI, NIDA, and NCI, each of whom will have one vote.  The NIH Project Scientists will constitute no more than one third of the voting membership.  In consultation with other NIH program scientists, the NHLBI program scientist will appoint the chair of the steering committee.  The steering committee will meet by teleconference on at least a quarterly basis and annually in person.

The NHLBI and other participating NIH Institutes will be substantially involved with the PRS and RCU awardees in a partnership role.  The NIH Program Scientists will collaborate on developing common measures, procedures and data management protocols, monitor study progress, insure disclosure of conflicts of interest and   adherence to NHLBI and NIH policies, and participate in data analysis and manuscript preparation as appropriate.   

A DSMB will be established to monitor and oversee participant safety in all of the studies supported by this initiative.  The NHLBI, in consultation from the other participating NIH institutes, will appoint the DSMB members, and the DSMB will report to the Director of the NHLBI.  Therefore, applicants should not appoint or inquire about interest in serving as a member of the DSMB because anyone so contacted would be ineligible to serve as a member of the peer review committee that will evaluate the applications for scientific merit.  Once constituted by the NHLBI, the DSMB will review the protocols of the FOA grantees at the initial meeting.  Subsequent semiannual meetings will monitor and review recruitment, adverse events, data quality, outcome data, and overall awardee performance.  The DSMB will be responsible for reviewing interim and final data, and recommend whether the study should be continued, modified, or terminated.   

Applicants to this FOA (HL-10-020) who are also interested in performing the RCU functions of this cooperative agreement should apply to the companion FOA soliciting applications for the RCU (RFA-HL-10-025).

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

Section II. Award Information


1. Mechanism of Support

This FOA will use the U01 award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.  

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

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

This funding opportunity will use an NIH cooperative agreement award mechanism. In the cooperative agreement mechanism, the PD(s)/PI(s) retain(s) 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 PD(s)/PI(s), as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award."

2. Funds Available

The NHLBI expects to award $13.5 million in total costs over four years to fund three to four awards through this announcement. NIDA and NCI each expect to award $3.8 million in total costs over four years to fund approximately one award each.  Together, NHLBI, NIDA, and NCI expect to award $21.1 million over four years to fund five to six awards through this announcement.  Budgets for direct costs up to $600,000 each year may be requested for a maximum of $2.4 million direct costs over the four-year period.  All applicants are expected to include in their budgets expenses for one face-to-face meeting per year in the Washington, DC area to coordinate measurement and data management efforts for data aggregation and sharing between grantees under this FOA.   

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

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

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

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

The PD/PI for the PRS must not be the same PD/PI for a RCU application. However, the PD/PI for the PRS can be from the same institution as the PD/PI for a RCU.

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

Milestones.  All applications must include a specific section labeled “Milestones” for each year.  Milestones should be annual, well described, quantitative, and scientifically justified; not simply a restatement of specific aims.  Rather, the milestones should offer a timeline and a “pathway” for the development and implementation of the proposed project.  These milestones will be used to judge the success of the proposed research on an individual project basis.  It is anticipated that these milestones will be adjusted annually to incorporate the network’s progress and accomplishments, and any steering committee recommendations.

Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct. Institutions are encouraged to submit an application for both a PRS and a RCU, but each must have a different PI/PD.

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

Renewals.  Renewal applications will not be permitted for this FOA.

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.

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 SO or 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 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.

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

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Letters of Intent Receipt Date: December 18, 2009
Application Due Date: January 19, 2010
Peer Review Date: June 2010
Council Review Date: August 2010
Earliest Anticipated Start Date: January 2011

3.A.1. Letter of Intent

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

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

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

The letter of intent should be sent to:

Director, Office of Scientific Review
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7214
Bethesda, MD  20892-7924
Bethesda, MD  20817 (express/courier service)
Telephone:  301-435-0270
FAX:  301-480-0730
Email: nhlbichiefreviewbranch@nhlbi.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 (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).

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

Director, Office of Scientific Review
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7214
Bethesda, MD  20892-7924
Bethesda, MD  20817 (express/courier service)
Telephone:  301-435-0270
FAX:  301-480-0730
Email: nhlbichiefreviewbranch@nhlbi.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 CSR and for responsiveness by the reviewing Institute.  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.

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).

6. Other Submission Requirements and Information

Applicants should indicate their willingness to collaborate with the other awardees of this FOA on the development and use of standardized measures, methods, and data management whenever feasible.  Applicants should include the costs of travel to annual steering committee meetings (PI plus one additional investigator) in the Washington, DC area.

To be considered responsive to this FOA, applicants also must: (a) include sufficient numbers of patients admitted for acute MI, CHF, and pneumonia to allow for subgroup analyses of these patients, (b) include cost-effectiveness analyses in the statistical plan, and (c) utilize existing healthcare staff, not research staff, to deliver any of the smoking cessation interventions that require staff involvement.      

Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information."

Research Plan Page Limitations

The U01 application Research Plan component of the PHS398 may not exceed 12 pages, including tables, graphs, figures, diagrams, and charts.

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. 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 of the Research Plan component. 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 and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).

(a) Data Sharing Plan: 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 NOT-OD-04-042).

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

The data sharing plan noted above is expected to include a description of how research data will be shared among those awarded grants under this FOA to optimize the potential for data aggregation efforts.  Investigators awarded under this FOA are expected to meet early in the first year of the project to coordinate measurement, data collection, and data management efforts to facilitate data aggregation and sharing. 

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 this FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NHLBI 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? Does the applicant indicate willingness to collaborate with other awardees on common measures and data sharing?

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? Does the project include analyses of cost-effectiveness and are these analyses appropriate and feasible? Are existing healthcare staff, not research staff, used to deliver any of the smoking cessation interventions that require staff involvement? Are sufficient numbers of acute MI, CHF, and pneumonia patients included to allow for subgroup analyses of patients admitted for these conditions vs other conditions? 

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

Additional Review Criteria

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

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

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

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

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.

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

Additional Review Considerations

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

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

Select 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).

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

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

3. Anticipated Announcement and Award Dates

Not applicable 

Section VI. Award Administration Information


1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

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 U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) 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.

2. A.1. Principal Investigator Rights and Responsibilities

The PD(s)/PI(s) will have the primary responsibility for planning, directing, and executing all aspects of the proposed study, including any modifications to study design, conduct of the study, quality control, data analysis, preparation of publications, and collaboration with other investigators, unless otherwise provided for in these terms or by recommendation of the Steering Committee.   

PRS investigators with assistance of the RCU are encouraged to publish and to release publicly and disseminate results and other products of the study, in accordance with study protocols and governance.  Within three years of the end of the period of NHLBI support for the project, data not previously released and other study materials or products not previously distributed are to be made available to individuals who are not study investigators, provided such release is consistent with the study protocol and governance and with 2.A.2, paragraph 2.  In addition, study investigators must establish a plan for making data sets and materials available to the scientific community and to the NHLBI immediately upon completion of the three year period following the end of the period of NHLBI support.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

2. A.2. NIH Responsibilities

NIH Project Scientists will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

NIH Project Scientists will serve on the Steering Committee, and may serve on other study committees as appropriate.  NIH Project Scientists (and other NIH scientists involved with the project) may work with awardees on issues coming before the Steering Committee, and other committees as appropriate including recruitment, intervention, follow-up, quality control, adherence to protocol, assessment of problems encountered during study implementation, interim data and safety monitoring, final data analysis and interpretation, and preparation of publications.

The NIH reserves the right to phase out  curtail or end the study (or an individual award) in the event of: (a) failure to develop and implement a mutually agreeable collaborative protocol, (b) substantial shortfall in participant recruitment, follow-up, data reporting, or quality control, (c) major breach of protocol or substantive changes in the agreed-upon protocol with which NIH did not concur, or (d) human subject ethical issues that may dictate premature termination. 

Support or other involvement of industry or any other third party in the study may be advantageous and appropriate.  However, except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification of and concurrence by NIH. 

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

The assigned program director may also serve as an NIH Project Scientist.

2.A.3. Collaborative Responsibilities

Awardees agree to the governance of the study through a Steering committee. Steering Committee voting membership shall consist of the principal investigators (i.e. cooperative agreement awardees), the RCU Principal Investigator awarded under the complementary FOA (HL-10-025) if not one of the principal investigators awarded under this FOA, and specified NIH Project Scientists who will not exceed one third of the total voting membership.  The NHLBI Project Scientist will appoint the chair of the steering committee.  Meetings of the Steering Committee will typically be held by teleconference or in-person meetings in the Washington, DC area. 

A Data and Safety Monitoring Board (DSMB) will be appointed by the NHLBI Director to provide overall monitoring of interim data and safety issues.  The Steering Committee will nominate members of this board.  Meetings of the DSMB will typically be held by teleconference or in-person meetings in the Washington, DC area.  An NIH scientist other than the NIH Project Scientists shall serve as the Executive Secretary to the DMSB.  Because the DSMB serves as an independent group advisory to the NIH, study investigators will not communicate with Board members regarding specific study issues except as authorized by the Board’s Executive Secretary. 

The collaborative protocol and governance policies will call for the regular sharing of data collected to the RCU for data aggregation, the submittal of copies of the final aggregated datasets to each PI upon completion of the study, procedures for data analysis, reporting and publication, and procedures to insure the privacy of the medical and genetic data and records of the individuals.  The NIH Project Scientists, on behalf of NIH, will have the same access, privileges, and responsibilities regarding the aggregated or collaborative data as the other members of the Steering Committee. 

Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

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 composed of three members will be convened. It will have 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 regulation 42 CFR Part 50, Subpart D and DHHS regulation 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 (program), peer review, and financial or grants management issues:

1. Scientific/Research Contact(s):

William Riley, Ph.D.
Division of Prevention and Population Sciences
National Heart, Lung, and Blood Institute
Rockledge 2, Room 10224
6701 Rockedge Dr.
Bethesda, MD 20892-7936

Telephone: (301) 435-0407
Fax: 301-480-1455
Email: wiriley@mail.nih.gov

Debra Grossman, M.A.
Division of Clinical Neuroscience and Behavioral Research
National Institute on Drug Abuse
6001 Executive Blvd., Room 3153
MSC 9551
Bethesda, MD 20892-9551
Telephone: (301) 443-0107
Fax: 301-443-6814
Email: dgrossma@mail.nih.gov

Michele Bloch, M.D., Ph.D. 
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Blvd., Room 4038
MSC 7337
Bethesda, MD 20892-7337
Telephone: (301) 402-5284
Fax: 301-496-8675
Email: blochm@mail.nih.gov

2. Peer Review Contact(s):

Director, Office of Scientific Review
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7214
Bethesda, MD  20892-7924
Bethesda, MD  20817 (express/courier service)
Telephone:  301-435-0270
FAX:  301-480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

3. Financial/Grants Management Contact(s):

Ms. Tawana McKeither
National Heart, Lung, and Blood Institute
Division of Extramural Research Administration
Office of Grants Mangement
6701 Rockledge Drive, Suite 700
Bethesda, MD 20892-7924
Telephone 301-435-0166
FAX: 301 451-5642
Email: mckeitherta@nhlbi.nih.gov

Section VIII. Other Information


Required Federal Citations

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

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

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

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies and local institutional review board (IRB) rules, as well as local, state and federal laws and regulations, including the Privacy Rule.

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

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

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

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

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

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, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

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

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

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

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

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

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

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.