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)
Title: Cross
Organ Mechanism-Associated Phenotypes for Genetic Analyses of Heart, Lung,
Blood, and Sleep Diseases (MAPGen for HLBS) Research Centers (U01)
Announcement Type
New
Request For Applications (RFA) Number: RFA-HL-11-005
Catalog of Federal Domestic Assistance Number(s)
93.838,
93.233, 93.837, 93.839
Key Dates
Release Date: February 24, 2010
Letters of Intent Receipt Date: August 2, 2010
Application Receipt
Date: September
1, 2010
Peer Review Date: February 2011
Council Review Date: May 2011
Earliest Anticipated Start Date: July 1, 2011
Additional Information To Be Available Date (Url
Activation Date): Not
applicable.
Expiration Date: September 2, 2010
Due Dates
for E.O. 12372
Not
Applicable
Additional
Overview Content
Executive Summary
Table of Contents
Part
I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review and
Anticipated Start Dates
1.
Letter of Intent
B. Sending an Application to
the NIH
C. Application Processing
D. Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
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. Dispute
Resolution Process
3.
Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II
- Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
The traditional clinical/organ system orientation of
disease definitions groups patients with similar presentations, often ignoring
differences in environmental exposures, clinical courses, and underlying
pathobiology. Thus, patients with essentially different underlying
pathologies will be grouped together under a common disease. This becomes
problematic when patients with different underlying pathologies, but similar
disease diagnoses, respond differentially to treatment. The focus on a
subset of clinical manifestations leads to an oversimplified approach to
disease definition and treatment and obscures possible pathogenetic overlaps
among diseases as well as weakening genotype-phenotype correlations.
A new paradigm needs to be developed for characterizing research subjects, which will focus on phenotypic traits chosen to reflect fundamental biological processes, instead of the clinical symptoms of a traditionally defined organ system disease. Medicine has long recognized that diseases co-exist, one disease may have manifestations in multiple organs, or that one medication may affect multiple organ systems. Now there is increasing appreciation of the interconnectedness of traditionally defined diseases. Research discovery shows that many genes contribute to the manifestations of one traditionally defined disease, a single gene may be associated with more than one traditionally defined disease, and there are many connections among biological pathways.
Measures that define phenotype by mechanism across a wide range of study populations will yield a more integrated understanding of pathobiology across pre-disease and disease states, recognition of subpopulations within heterogeneous diseases, more precise use of molecular target-direct therapies, and, ultimately, stronger associations with genetic variants than have typically been found using disease-related phenotypes. The ultimate goal is to achieve effective, personalized medical care through more precise identification of populations that will benefit from mechanism-based interventions for prevention and treatment.
This consortium seeks to identify and characterize common pathobiologic traits and/or mechanisms that cross organ systems and diseases with the ultimate goal of redefining heart, lung, blood, and sleep disorders based on new found knowledge of the underlying molecular and/or cellular pathobiology. This will provide the basis for the rational, mechanism-based development of new diagnostic, prognostic and therapeutic strategies for heart, lung, blood and sleep disorders.
In order to achieve this goal, prospective applicants are expected to identify and define alterations in fundamental processes that can be found in at least two traditionally defined organ systems and at least two disorders (one of which is required to be of the heart, lung, blood or sleep). Proposed research should seek to illuminate the commonality of altered biologic processes and how these alterations manifest, according to local milieu, into organ specific disorders. Research utilizing organ systems and disorders seemingly unrelated to heart, lung, blood and sleep is allowed, however, findings must be translated to fulfill the programmatic goal of providing insight specifically into heart, lung, blood, and sleep disorders and identifying markers that can be used for diagnosis, prognosis or treatment response. Prospective applicants are strongly encouraged to establish transdisciplinary teams as needed to attain this goal and may use the multiple principal investigators (PI) option (see http://grants.nih.gov/grants/multi_pi/index.htm). Hypotheses may be tested or developed regarding shared underlying mechanisms through the analysis of existing information or laboratory or clinic-based research projects. Investigators may begin with genes now found to be common to disparate diseases and identify a function and associated marker or investigators may begin with proposed mechanism(s) and test its commonality across diseases. The use of animal models is permitted, but they cannot be used solely for discovery and cannot exceed 20% of the total research effort.
Proposed research is expected to focus on cross-organ mechanisms and contribute to the identification and validation of markers of common biological processes. Markers may be cellular, biochemical, or molecular and should be applicable as practical measures in clinical studies and trials of characterized subjects. Applicants may propose new analyses of existing samples from characterized subjects or assemble new cohorts Behavioral approaches can be a component of the study but not the sole component or outcome. Applications may propose studies using methods not currently adapted for widespread application but must provide a plan and milestones for translation and validation of the discovery for future use in large human cohorts or population based studies to improve diagnosis, prognosis and the ability to predict therapeutic response.
Research Topics
The following are examples of research topics responsive to this FOA. These are only examples; applicants should not feel limited to the subjects mentioned and are encouraged to submit other topics pertinent to the objectives of this FOA.
Research projects that are not responsive to this FOA are:
Organization of MAPGen
MAPGen will be a cooperative consortium of up to 8 Research Centers, one MAPGen Knowledge Base and Coordinating Center (MAPGenKB), and the NHLBI.
NHLBI will award funds to the MAPGenKB in years 3 and 4 that will be restricted for execution of newly developed research protocols developed collaboratively by the members of the SC. After approval by the SC, protocols will be reviewed by the external consultants (with added ad hoc expertise, as necessary) to the SC. The consultants will make recommendations to the NHLBI regarding merit and prioritization of additional protocols. Other major scientific decisions will be determined by majority vote of the SC. Each Research Center, the MAPGenKB, and the NHLBI will have one vote; the Study Chair will have a vote in case of a tie vote among the other SC members. Note that if a Research Center has multiple PIs, all PIs are expected to participate in all SC meetings, but each Research Center has one vote. It is anticipated that the SC will meet two times a year by in-person meetings. The SC will have primary responsibility for the general organization of MAPGen, sharing and extending original research hypotheses and findings, prioritizing proposed topics for investigations, finalizing research protocols, facilitating the conduct and monitoring of the studies, reporting study results in a timely manner, and working with the NHLBI to promote dissemination of the findings. Topics for the research protocols will be proposed and prioritized by the SC. For each protocol, one Research Center will take the lead responsibility for drafting the protocol and budget. The SC has final responsibility for approving research protocols, protocol budgets, and protocol revisions, before review by the external consultants or NHLBI. Subcommittees of the SC will be established to perform specific functions such as Group Publications and Presentations and Quality Control. Oversight committees, such as a DSMB or OSMB, may be appointed at the discretion of the NHLBI. Awardee members of the SC will be required to accept and implement policies approved by the SC.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism of Support
This funding
opportunity will use the Cooperative Agreement (U01) award mechanism(s).
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. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award."
2. Funds Available
The
total amount of funding that the NHLBI expects to award for MAPGen (for up to 8
Research Centers and 1 MAPGenKB) is $25 million for a project period of up 4
years for the Research Centers and 5 years for the MAPGenKB. Designated
funding levels are subject to change at any time prior to award, due to
unforeseen budgetary, administrative or scientific developments.
The NHLBI anticipates awarding up to 8 Research Centers in response to this FOA, and 1 MAPGen Knowledge Base and Coordinating Center in response to a separate FOA (see HL-11-004). Out of the total funds for MAPGen and in response to this FOA, the NHLBI expects to award approximately $20 million total costs over 4 years for up to 8 Research Centers. RCs may request direct costs of up to $400,000 per year (exclusive of indirect costs associated with consortia) and a project duration of up to 4 years for a maximum of $1,600,000 direct costs over a 4-year project period.
Because
the nature and scope of the proposed research will vary from application to
application, it is anticipated that the size and duration of each award will
also vary. Although the financial plans of the IC(s) provide support for this
program, awards pursuant to this funding opportunity are contingent upon the
availability of funds and the receipt of a sufficient number of meritorious
applications.
Facilities and
administrative costs requested by consortium participants are not included in
the direct cost limitation, see NOT-OD-05-004.
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 with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH program support.
More than one PD/PI, or 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, 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 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 is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
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
Number of
Applications. Applicants may submit more than one application, provided they are
scientifically distinct.
Resubmissions. Resubmission applications are not permitted in response to this FOA.
Renewals. Renewal applications are not permitted in response to this FOA.
Section IV. Application and Submission Information
1. Address to
Request Application Information
The current 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
Prepare all applications using the PHS 398 application forms and in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html).
Applications must have a D&B Data Universal
Numbering System (DUNS) number as the universal identifier when applying for
Federal grants or cooperative agreements. The D&B number can be obtained by
calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number
should be entered on line 11 of the face page of the PHS 398 form.
The title and
number of this funding opportunity must be typed in item (box) 2 only of the
face page of the application form, and the YES box must be checked.
Foreign
Organizations (Non-domestic
(non-U.S.) Entity)
NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from foreign organizations must:
In addition, for applications from foreign organizations:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
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.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the Research Plan section and the 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
Applications must be
received on or before the receipt date described below (Section
IV.3.A). Submission times N/A.
3.A. Receipt, Review and Anticipated Start Dates
Letters
of Intent Receipt Date: August
2, 2010
Application Receipt Date: September 1, 2010
Peer Review Date: February 2011
Council Review Date): May
2011
Earliest
Anticipated Start Date: July
1, 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
Division of
Extramural Research Activities
National
Heart, Lung, and Blood Institute
6701
Rockledge Drive, Room 7214
Bethesda,
MD 20892-7924 (Express Mail Zip: 20817)
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
Division of
Extramural Research Activities
National
Heart, Lung, and Blood Institute
6701
Rockledge Drive, Room 7214
Bethesda,
MD 20892-7924 (Express Mail Zip: 20817)
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. The Grants Policy Statement can
be found at NIH Grants
Policy Statement.
Pre-award costs are allowable. A grantee may, at its
own risk and without NIH prior approval, incur obligations and expenditures to
cover costs up to 90 days before the beginning date of the initial budget
period of a new award if such costs: (1) are necessary to conduct the project,
and (2) would be allowable under the grant, if awarded, without NIH prior approval.
If specific expenditures would otherwise require prior approval, the grantee
must obtain NIH approval before incurring the cost. NIH prior approval is
required for any costs to be incurred more than 90 days before the beginning
date of the initial budget period of a new award.
The incurrence
of pre-award costs in anticipation of a competing or non-competing award
imposes no obligation on NIH either to make the award or to increase the amount
of the approved budget if an award is made for less than the amount anticipated
and is inadequate to cover the pre-award costs incurred. NIH expects the
grantee to be fully aware that pre-award costs result in borrowing against
future support and that such borrowing must not impair the grantee's ability to
accomplish the project objectives in the approved time frame or in any way
adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)
6. Other Submission Requirements
Qualifications and Experience.
Applicants should describe qualifications and experience in the appropriate
narrative sections of the application and in biosketches. Participation
in MapGen will be a complex and time-consuming undertaking. Applicants
for Research Centers must have the necessary experience and expertise.
Applicants should have an established research program and demonstrated
leadership. An appropriate time commitment is expected from the principal
investigators and any co-investigators at each Research Center. If the
multiple PI option is used, a Leadership Plan must be included in the research
plan section of the application.
Collaboration. Applicants should state their general support of
collaborative research and their willingness to participate in a collaborative
and interactive manner with other Research Centers, the MAPGen Knowledge Base
and Coordinating Center, and the NHLBI in all aspects of the MAPGen consortium.
Applicants should indicate willingness to participate in data and model sharing
with other MAPGen RCs and the MAPGenKB as well as contribute to an eventual
publicly accessible database. Applications should a include a resource plan for
data and/or model organisms, as appropriate. Applicants are encouraged to
describe any special expertise or unique strengths they can offer to the
collaborative effort (e.g., genetics/genomics/proteomics, bioinformatics, team
leadership and training, dissemination activities).
Applicants must agree, if awarded, to accept the “Cooperative Agreement
Terms and Conditions of Award” in Section VI. 2. A. “Award
Administration Information.”
Applicants should indicate their willingness to attend all Steering Committee
meetings in the greater Washington D.C. area, which may include conference
calls up to two times a month and in-person meetings up to four times a year,
particularly in the first year. Applicants must budget travel funds for
the PI, at a minimum, to attend all SC meetings. , Research Center applicants should be able to interact with the MAPGen Knowledge Base and Coordinating Center to transmit and edit data and within the 12 page Research Strategy
section of the application, Research Center applicants should
discuss their capability to participate in a distributed data entry system.
PHS398 Research Plan Component Sections
All application instructions outlined in the PHS 398 Application Guide are to be followed, with the following additional requirements:
Budget Component
This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096.
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. An application that does not observe the required page limitations may be delayed in the review process.
Resource Sharing Plan(s)NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.
Specific Instructions for Foreign Applications
All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096.
Section V. Application Review Information
1. Criteria
Only the review
criteria described below will be considered in the review process.
2. Review and Selection Process
Review Process
Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by 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 scored review criteria, and additional review criteria (as applicable for the project proposed).
Scored 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, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach. Are the overall strategy, methodology, and analyses well-reasoned
and appropriate to accomplish the specific aims of the project? Are
potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development,
will the strategy establish feasibility and will particularly risky aspects be
managed?
If the project involves clinical research, are the plans for (1) protection of
human subjects from research risks, and (2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?
Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
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. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.
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.
Resubmission Applications. Resubmission applications are not permitted in response to this FOA.
Renewal Applications. Renewal applications are not permitted in response to this FOA.
Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
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.
Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
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).
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.
Selection Process
The following will be considered in making funding decisions:
3. Anticipated Announcement and Award
Dates
Not Applicable
Section
VI. Award Administration Information
1. Award Notices
After the peer review
of the application is completed, the PD/PI will be able to access his or her
Summary Statement (written critique) via the eRA Commons.
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General.
A
formal notification in the form of a Notice of Award (NoA) will be
provided to the applicant organization. The NoA signed by the grants management
officer is the authorizing document. Once all administrative and programmatic
issues have been resolved, the NoA will be generated via email notification
from the awarding component to the grantee business official.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Also Section
IV.5. Funding Restrictions.
2. Administrative and National
Policy Requirements
All NIH grant and cooperative
agreement awards include the NIH Grants Policy Statement as part of the NoA.
For these terms of award, see the NIH Grants Policy Statement Part II: Terms
and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.
2.A. Cooperative Agreement Terms
and Conditions of Award
The following special
terms of award are in addition to, and not in lieu of, otherwise applicable OMB
administrative guidelines, HHS grant administration regulations at 45 CFR Parts
74 and 92 (Part 92 is applicable when State and local Governments are eligible
to apply), and other HHS, PHS, and NIH grant administration policies.
The administrative and funding
instrument used for this program will be the cooperative agreement, an
"assistance" mechanism (rather than an "acquisition"
mechanism), in which substantial NIH programmatic involvement with the awardees
is anticipated during the performance of the activities. Under the cooperative
agreement, the NIH purpose is to support and stimulate the recipients'
activities by involvement in and otherwise working jointly with the award
recipients in a partnership role; it is not to assume direction, prime responsibility,
or a dominant role in the activities. Consistent with this concept, the
dominant role and prime responsibility resides with the awardees for the
project as a whole, although specific tasks and activities may be shared among
the awardees and the NIH as defined below.
2.
A.1. Principal Investigator Rights and Responsibilities
The
Principal Investigator will have the primary responsibility for all aspects of
the MAPGen studies, including conducting the research, collaborative
development of additional group protocols, and timely transmission of data
collected in conjunction with the MAPGenKB, analyzing and interpreting data,
preparing publications, and working with the MAPGenKB and NHLBI to disseminate
research findings. Research Center PIs will also be responsible for
working with the MAPGenKB to develop common definitions and standardization
across protocols, if appropriate.
The MAPGen Knowledge Base and Coordinating Center Principal Investigator will be responsible for the overall function of the MAPGenKB, which is to coordinate, administer, and support all collaborative MAPGen research activities. The MAPGenKB PI will be responsible for oversight of aspects of data collection, data safety and confidentiality, quality assurance, data analysis, coordination of data distribution, and implementation of all data sharing plans. The MAPGenKB PI will be responsible for the distribution of protocol funds to the Research Centers (see “Funds Available” in Section II. The MAPGenKB PI will be responsible for the editorial and meeting coordination for manuscript preparation, coordination of the activities of the Steering Committee and other committees and/or advisory boards, as needed.
It is possible that some MAPGen studies will
involve support or other involvement of industry or other third parties.
However, except for licensing of patents or copyrights, support or involvement
of any third party will occur only following notification of and concurrence by
NHLBI. Awardees must follow NHLBI policy concerning third party
agreements.
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
HHS, PHS, and NIH policies.
2.
A.2. NIH Responsibilities
MAPGen
will have one or more NIH Project Scientists who will also serve as program
directors; they will share participation in overall Steering Committee
activities. Several procedures are in place to manage potential conflict of
interest by project scientists (PS) administering the cooperative agreement.
These include: the project scientists adhere to stringent NIH
ethics rules and financial disclosure reporting to eliminate overt and
perceived conflict of interest; PS are prohibited from observing scientific
review of competing applications from an investigator with whom they have
published in the last three years; recommendations from PS about budgetary
requests (e.g., carryover, administrative supplements, no-cost extensions) are
reviewed and approved by supervisors (e.g., Branch Chiefs, Division Director,
and, Institute Director); recruitment progress is reviewed by study independent
staff (quarterly within the Division; semi-annually or quarterly by the DSMB/OSMB
and supervisory staff; PS may be asked to leave the room during DSMB/OSMB
reviews of studies; recommendations made by PS in annual progress reports are
reviewed by grant specialists with a separate Division (Office of Grants
Management); PS will not seek lead authorship of primary publications and will
obtain approval by Branch Chief to participate in secondary publications.
The NHLBI Project Scientists may work with
awardees on issues coming before the Steering Committee and, as appropriate,
other committees (e.g., assessment of problems affecting the study and
potential changes in the protocol, interim data and safety monitoring, final
data analysis and interpretation, preparation of publications, and development
of solutions to major problems). The NHLBI Project Scientists, on behalf
of the NHLBI, will have the same access, privileges, and responsibilities
regarding the collaborative data as the other members of the Steering
Committee.
The NHLBI reserves the right to terminate or curtail the MAPGen consortium (or
an individual award) in the event of (1) major breach of a protocol or
substantive changes in the agreed-upon protocol with which NHLBI cannot concur
or (2) human subject ethical issues that may dictate a premature termination.
Annual continuation and level of funding for
each Research Center will be based on NHLBI review of actual recruitment, if
applicable, and overall performance, determined as part of the NHLBI review of
the annual non-competing continuation grant progress reports submitted by
awardees.
2.A.3. Collaborative Responsibilities
Awardees agree to the governance of the study
through a Steering Committee (SC). All Principal Investigators and a
Chairperson, to be appointed by the NHLBI, will comprise the SC. All
major, collaborative scientific decisions will be determined by majority vote
of the SC. Each Research Center, the Data Information and Coordinating Center, and the NHLBI Project Office will have one vote; the Chair will have
one vote in case of a tie. If a Research Center, chooses to have multiple
PIs, the Center in question will still have one vote. It is anticipated
that SC meetings will be held twice a month by conference call and up to two
times a year (may be up to four times during the first year) in person in the
greater Washington, D.C area. At a minimum, PI(s) must attend each SC meeting
and each RC must budget travel funds for this purpose.
Awardee Members of the Steering Committee
will be required to accept and implement policies approved by the Steering
Committee.
2.A.4.
Dispute Resolution Process
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 Dispute Resolution. 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 regulations 42 CFR Part 50,
Subpart D and HHS regulations 45 CFR Part 16.
3. Reporting
Awardees will be
required to submit the Non-Competing
Continuation Grant Progress Report (PHS 2590) annually and financial
statements as required in the NIH Grants
Policy Statement.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
We encourage your inquiries concerning this funding
opportunity and welcome the opportunity to answer questions from potential
applicants. Inquiries may fall into three areas: scientific/research, peer
review, and financial or grants management issues:
1. Scientific/Research Contacts:
Patricia
Noel, Ph.D.
Division of
Lung Diseases
National
Heart, Lung, and Blood Institute
6701
Rockledge Drive, Room 10042
Bethesda,
MD 20892-7952
Telephone:
(301) 435-0202
FAX: (301)
480-3557
Email: [email protected]
Jennie Larkin, Ph.D.
Division of
Cardiovascular Diseases
National
Heart, Lung, and Blood Institute
Rockledge
2, Room 8200
6701 Rockledge Dr.
Bethesda, MD 20892-7940
Telephone:
(301) 435-0513
Fax: (301)
480-1454
Email: [email protected]
Pankaj Qasba, Ph.D.
Division of
Blood Diseases and Resource
National
Heart, Lung, and Blood Institute
6701
Rockledge Drive, Room 9030
Bethesda, MD 20892-7950
Telephone:
(301) 435-0050
FAX: (301)
480-0868
Email: [email protected]
2. Peer Review Contacts:
Director,
Office of Scientific Review
Division of
Extramural Research Activities
National Heart, Lung,
and Blood Institute
6701 Rockledge Drive,
Room 7214
Bethesda, MD 20892-7924 (Express Mail Zip: 20817)
Telephone: (301) 435-0270
FAX: 301-480-0730
Email: [email protected]
3. Financial or Grants Management Contacts:
Mr.
John Diggs
Office of Grants Management
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive,
Room 7128
Bethesda, MD 20816-7926
Telephone: 301-435-0166
FAX: 301-451-5462
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 (45CFR46) require that applications and proposals involving human
subjects must be evaluated with reference to the risks to the subjects, the
adequacy of protection against these risks, the potential benefits of the
research to the subjects and others, and the importance of the knowledge gained
or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and
Safety Monitoring Plan:
Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative
trials (Phase III). Monitoring should be commensurate with risk. The
establishment of data and safety monitoring boards (DSMBs) is required for
multi-site clinical trials involving interventions that entail potential risks
to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their
institutions, on issues related to institutional policies and local IRB rules,
as well as local, state and federal laws and regulations, including the Privacy
Rule.
Policy
for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/
Access
to Research Data through the Freedom of Information Act:
The Office of
Management and Budget (OMB) Circular A-110 has been revised to provide access
to research data through the Freedom of Information Act (FOIA) under some
circumstances. Data that are (1) first produced in a project that is supported
in whole or in part with Federal funds and (2) cited publicly and officially by
a Federal agency in support of an action that has the force and effect of law
(i.e., a regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has provided
guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
Sharing of Model
Organisms:
NIH is committed to
support efforts that encourage sharing of important research resources
including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004, receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.
Inclusion of Women
And Minorities in Clinical Research:
It is the policy of the
NIH that women and members of minority groups and their sub-populations must be
included in all NIH-supported clinical research projects unless a clear and
compelling justification is provided indicating that inclusion is inappropriate
with respect to the health of the subjects or the purpose of the research. This
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public
Law 103-43). All investigators proposing clinical research should read the
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: (a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and (b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of
Children as Participants in Clinical Research:
The NIH maintains a
policy that children (i.e., individuals under the age of 21) must be included
in all clinical research, conducted or supported by the NIH, unless there are
scientific and ethical reasons not to include them.
All investigators
proposing research involving human subjects should read the "NIH Policy
and Guidelines" on the inclusion of children as participants in research
involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education
on the Protection of Human Subject Participants:
NIH policy requires
education on the protection of human subject participants for all investigators
submitting NIH applications for research involving human subjects and
individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human
Embryonic Stem Cells (hESC):
Criteria for
federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research.
NIH Public Access Policy Requirement:
In
accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html)
investigators must submit or have submitted for them their final, peer-reviewed
manuscripts that arise from NIH funds and are accepted for publication as of
April 7, 2008, to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly
available no later than 12 months after publication. As of May 27, 2008, investigators
must include the PubMed Central reference number when citing an article in NIH
applications, proposals, and progress reports that fall under the policy, and
was authored or co-authored by the investigator or arose from the
investigator’s NIH award. For more information, see the Public
Access webpage at http://publicaccess.nih.gov/.
Standards
for Privacy of Individually Identifiable Health Information:
The Department
of Health and Human Services (DHHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health Information,"
the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal
regulation under the Health Insurance Portability and Accountability Act (HIPAA)
of 1996 that governs the protection of individually identifiable health
information, and is administered and enforced by the DHHS Office for Civil
Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH
Grant Applications or Appendices:
All
applications and proposals for NIH funding must be self-contained within
specified page limitations. For publications listed in the appendix and/or
Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for the review because reviewers are
under no obligation to view the Internet sites. Furthermore, we caution
reviewers that their anonymity may be compromised when they directly access an
Internet site.
Healthy
People 2010:
The Public Health
Service (PHS) is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This FOA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.
Authority and
Regulations:
This
program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive
Order 12372. Awards are made under the authorization of Sections 301 and 405 of
the Public Health Service Act as amended (42 USC 241 and 284) and under Federal
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the
terms and conditions, cost principles, and other considerations described in
the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
Loan
Repayment Programs:
NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40-hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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