and Human Services (HHS)
EXPIRED
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 smoke. Smoking-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 required. Quality 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 NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
1.A.
Eligible Institutions
The following
organizations/institutions are eligible to apply:
1.B. Eligible Individuals
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a 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) 710-0267, Email: [email protected].
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: [email protected]
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: [email protected]
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.
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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
Section VIII. Other Information
Required Federal Citations
Use of Animals
in Research:
Recipients of PHS support for activities involving
live, vertebrate animals must comply with PHS Policy on Humane Care and Use of
Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects
Protection:
Federal regulations (45 CFR 46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety
Monitoring Plan:
Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative
trials (Phase III). Monitoring should be commensurate with risk. The
establishment of data and safety monitoring boards (DSMBs) is required for
multi-site clinical trials involving interventions that entail potential risks to
the participants ( NIH Policy for Data and Safety Monitoring, NIH Guide for
Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their
institutions, on issues related to institutional policies and local
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
|
| ||||||
|
|
|
Department of Health and Human Services (HHS) |
|
|||
|
NIH... Turning Discovery Into Health® |
||||||