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
Office of Behavioral and Social Sciences Research (OBSSR) http://obssr.od.nih.gov
National Center for Complementary
and Alternative Medicine (NCCAM) http://nccam.nih.gov
National Institute of Aging (NIA) http://www.nia.nih.gov
National Institute of Alcohol Abuse and Alcoholism (NIAAA) http://www.niaaa.nih.gov
National Institute of Arthritis and Musculoskeletal
and Skin Diseases (NIAMS) http://www/niams.nih.gov/
National Institute of Child Health and Human
Development (NICHD) http://www.nichd.nih.gov
National Institute of Dental and Craniofacial
Research (NIDCR) http://www.nidcr.nih.gov
National Institute of Diabetes and Digestive and
Kidney Diseases (NIDDK) http://www.niddk.nih.gov
National
Institute for Drug Abuse (NIDA) http://www.nida.nih.gov
National Human
Genome Research Institute (NHGRI) http://www.genome.gov
National Institute of Mental Health (NIMH) http://www.nimh.nih.gov
National Institute of Neurological Disorders and
Stroke (NINDS) http://www.ninds.nih.gov
Title: NIH
Revision Awards for Studying Interactions Among Social, Behavioral, and Genetic
Factors in Health (P01, P20, P50, P60, U01, U10,
U54)
Announcement Type
New
Program Announcement (PA) Number: PAR-08-067
Catalog of Federal
Domestic Assistance Number(s)
93,213, 93.847, 93.848, 93.849, 93.837, 93.838,
93.866, 93.273, 93,865, 93.279, 93.172, 93.242, 93.853
Key Dates
Release Date: January 8, 2008
Letters of Intent
Receipt Date(s): April 13, 2008
Application Submission/Receipt Date(s): May 13, 2008
Peer Review Date(s): October/November 2008
Council Review Date(s): January 2009
Earliest Anticipated Start Date(s): April 2009
Additional Information To
Be Available Date (Activation Date): Not Applicable
Expiration Date: May 14, 2008
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. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II
- Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Nature of the Research Opportunity
The National Institutes of Health (NIH) issues this Funding Opportunity Announcement (FOA) to invite applications from currently NIH-funded investigators to supplement their currently funded research to study how interactions among genetic and behavioral/social factors influence health and disease. The knowledge gained by such research will improve our understanding of the determinants of disease as well as inform efforts to reduce health risks and provide treatment. This FOA solicits for human and non-human studies to advance our understanding of the interactions among genetic, social and behavioral factors that influence the processes affecting variability in disease and health progression and outcomes. This program is focused on questions concerning the effects of (1) the interaction of genetic and social and/or behavioral factors (2) gene-environment-behavioral interactions; and (3) how the interaction of behaviors and social environmental factors affect gene expression, disease and behavior phenotypes and health outcomes.
Currently, powerful genetic methods are being used for identifying common genomic factors that influence health and disease-related phenotypes and outcomes. These studies are designed to identify relationships between genes with observable traits such as body weight or the presence or absence of a disease or condition. Within this context, the Institute of Medicine Report, Genes, Behavior and the Social Environment: Moving Beyond the Nature-Nurture Debate suggests that examining the interactions among genetic, social environments, and behavioral factors could greatly enhance the understanding of health and illness. This report, which can be found at http://www.iom.edu/CMS/3740/24591/36574.aspx also recommends ways to foster transdisciplinary research teams necessary to more fully examine the questions raised by these research gaps. The NIH’s Office of Behavioral and Social Sciences Research (OBSSR), located in the Office of the Director, is leading the implementation of the recommendations produced by this report.
How genetic, behavioral, and social factors interact in human physiological processes and differentially influence disease expression and health outcomes remains understudied. A number of research gaps have been identified including the following: (1) genetic studies that explore the relationship between genotypes and quantitative traits often do not include social and behavioral factors, and (2) social and behavioral research studies rarely include consideration of genetic factors and related mechanisms when studying social and/.or behavioral phenomena.
To bridge these gaps, this announcement is intended to stimulate theoretically and methodologically rigorous research that integrates genetics, behavioral, and social sciences research efforts to specifically address questions of gene-environment-behavior interactions. This announcement provides the opportunity for current NIH-funded grantees whose research is either (1) social and/or behavioral science-oriented to add a genetic/genomic component or (2) genetic-focused to add social and behavioral factors into their research plan. In either case, the proposed research must be designed to elucidate how genetic and social or behavioral factors and their interactions contribute to health and disease. The proposed research can expand the scope of the original project and should be a logical extension of the goals and objectives of the parent grant
To be considered responsive to this announcement, (1) the proposed research must include unambiguous, interdisciplinary perspectives, (2) the hypothesis(es) of the relationship(s) between the genetics, behaviors, social environment, and/or social processes must be clearly stated, (3) hypothesis about the proposed study should investigate how the interactions (not associations) among these variables influence the outcomes under study, and (4) the proposed study should be embedded in a well articulated set of research questions or hypothesis generated from genetic, social and/or behavioral sciences research.
Background
Phenotype and disease variations among individuals within and between populations arise as a function of interactions between genetic, environmental, behavioral, and social factors that vary over the course of a person’s lifespan. Family, twin, adoption, and association studies have established the importance of genetic, environmental, and behavioral factors in influencing variation across a large array of disease and behavioral phenotypes related to personality, functional abilities, and health and disease status. Genetic linkage and association studies in humans and animals, as well as genetic manipulation of animals, have identified specific genes influencing some of these phenotypes. To further understanding of the mechanisms of action of these genes, innovative projects are needed that investigate the interactions between genetic effects and the environmental, behavioral, and social contexts in which they are expressed. These efforts will involve approaches that (1) integrate molecular and quantitative methods, (2) when possible, focus on behavioral systems for which known or candidate genes are identified, (3) measure biological intermediaries and endophenotypes of the behaviors, and (4) use analytic approaches with adequate statistical power to study the interaction of genes and their products, social and exposure environments, and behavioral factors.
There have been dramatic advances in identifying genes influencing complex diseases, assessing aggregate effects and associations of genetic and environmental factors, and in identifying biological mediators of complex social and behavioral phenotypes. The need to examine the interaction among genetic, behavioral and social factors in the context of health and disease systems is increasingly important. Scientific advances across many disciplines are now making studying the interaction of these factors possible. Understanding the interaction of genetic, environmental and behavioral factors will require integrating theoretical models and methodological approaches and harnessing the powerful research tools of multiple disciplines.
This Program Announcement encourages a wide range of research designs with an emphasis on supplementing data collection and/or analyses that will allow new hypotheses to be tested at the intersection of genetics, behavioral and social sciences research. Major methodological and analytic considerations need to be well articulated including the following: (1) interpretations of the significance of the genetic, environmental, behavioral, and social factors and their interactions; (2) documentation of rigorous research design and robust measurement characteristics; (3) power analyses to prove the sample sizes are sufficient for analysis of the interactions being studied, and; (4) clear descriptions of the analytic procedures being proposed. The research team must at a minimum include expertise in genetics (molecular and/or quantitative) and the social and/or behavioral sciences.
Scientific Knowledge to be Achieved:
The goal of this FOA is to generate additional human and non-human data or perform novel and cutting-edge analyses of existing data sets to better understand how the interaction of genetic, environmental, behavioral, and social factors influence health and disease outcomes and phenotype variation. This announcement identifies genetic, and behavioral and/or social factors and their interactions as a research area needing special attention and encouragement since these interactions are understudied and important when understanding disease processes, variations, and health outcomes.
Objectives:
This objective of this Program Announcement is to bridge disciplinary boundaries to study how the interactions of genetic, environmental, behavioral and social factors influence health and disease phenotype variations and outcomes. Progress in understanding gene-environment-behavior interactions must rely on integrating the theoretical and methodological approaches. Improved strategies now exist to identify genes, map quantitative trait loci (QTL), and assess specific genetic and behavioral/social sources of disease variation.
Program priority will be given to gene-environment-behavior interaction (not association) studies where 1) social and/or behavior science oriented studies add consideration of genetic factors, (2) genetics focused studies add social and/or behavioral factors, or (3) new data analyses of existing data sets contribute to better understanding of how gene X social X behavioral interactions influence health and disease outcomes and phenotype variation. The proposed research can expand the scope of the original project and be a logical extension of the goals and objectives of the parent grant.
A wide range of research designs is relevant to this program announcement. Examples of the research areas pertinent to this FOA include, but are not limited to:
Reference Report
The Institute of Medicine’s report, Genes, Behavior, and the Social Environment: Moving Beyond the Nature/Nurture Debate (2006) reviews a body of knowledge about genetics, behavior, and social environments. Potential applicants are encouraged to consult this report as a general reference http://www.iom.edu/CMS/3740/24591/36574.aspx.
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 NIH revision (formerly named competitive supplement) award to an existing NIH P01, P20, P50, P60, U01, U10, or U54 award. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This funding opportunity uses Just-in-Time information concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm).
Specifically, if you are a U.S. organization, use the PHS398 Modular Budget component
All foreign applicants must complete and submit budget requests using the Research & Related Budget component.
At this time, it is not known if this FOA will be reissued.
2.
Funds Available
The Office of Behavioral and Social
Sciences Research (OBSSR) of the Office of the Director intends to commit approximately $3 million dollars in FY2009 to fund 10 to 20 projects. Specifically, OBSSR intends to commit a total of
up to $ 3 million dollars in FY2009 spread across all three Program
Announcements. The financial plan of OBSSR provides support for this
program. Awards pursuant to this announcement are contingent upon the
availability of funds and the submission of a
sufficient number of meritorious applications. 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. The total amount awarded and the number of awards will depend
upon the mechanism numbers, quality, duration, and costs of the applications
received.
The project period and requested funding for the application submitted in response to this funding opportunity can be up to four (4) years and cannot extend beyond the project end date of the parent grant. Direct costs are limited to no more than $250,000 in any single year. Facilities and administrative costs requested by consortium participants are included in the direct cost limitation.
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
You may submit an application(s) if your
institution/organization has any of the following characteristics:
1.B. Eligible Individuals
Any individual who is an existing NIH-funded investigator who has the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. The PD/PI must be the same as the parent grant. 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, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach that clearly does 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. In the case of a multiPI revision application, the contact PD/PI must be the same as the contact PD/PI of the parent award.
The decision of whether to apply for a single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for multiple PD/PI grants will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. 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 PD/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
The
applicant must be the Principal Investigator of an existing NIH-funded Research
Project. Revision awards can only be awarded for research that is within the
scope of an eligible parent grant mechanism including
Investigator Initiated Projects (U01), Program Projects (P01, P20), or
Specialized Center (P50, P60, U10, or U54) awards.
The Principal Investigator must be the same person as is
the current Principal Investigator on the original application. A new or
additional co-investigator (i.e., multiple-PIs) may be designated for the
revision application. In such a case, one of the PIs or co-PIs must be the PI
of the exisiting award. A revision
application will not be accepted until after the original application has been awarded and may not extend beyond the
term of the current grant. The parent grant must have at least two years
remaining at application to be eligible. In all cases, a careful explanation
and justification for the revision as a logical extension
of the ongoing research must be included. The investigators should demonstrate
that their team has the appropriate (e.g., genomic, epidemiology, social
science, or behavioral science) expertise for the project proposed.
Applicants may submit more than
one application, provided each application is scientifically distinct.
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 on line 2 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.
Several special provisions apply to applications submitted by foreign organizations. Applications from foreign organizations must:
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
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the 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, including 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.
SPECIAL INSTRUCTIONS
Applications Involving Multiple Institutions
When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.
When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 5.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.
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(s): April 13, 2008
Application Submission/Receipt Date(s): May 13, 2008
Peer Review Date(s): October/November 2008
Council Review Date(s): January 2009
Earliest Anticipated Start Date(s): April 2009
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.
The letter of intent is to be sent by the date listed
at the beginning of this document in Section IV.3.A.
The letter of intent should be sent to:
Ronald P. Abeles, Ph.D.
Special
Assistant to the Director
Office
of Behavioral and Social Sciences Research
Office of the Director National
Institutes of Health
Bldg. 31C, Rm. B1C19, MSC 2027
31
Center Drive
Bethesda, MD 20892-2027 (Courier Services Zip Code 20814)
Phone:
301-496-7859
Fax:
301-435-8779
Email:
[email protected][email protected]
3.B. Sending an Application to the NIH
Applications must be prepared using the research grant
applications found in the PHS 398 instructions for preparing a research grant
application. Submit a signed, original of the application, including the
checklist, and five signed
photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service
Express or regular mail)
Bethesda, MD 20817 (for express/courier
service; non-USPS service)
Personal deliveries of applications are no longer
permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf..
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 to this FOA. Incomplete and 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 http://grants1.nih.gov/grants/policy/nihgps_2003/index.htm.)
Pre-award costs are allowable. A grantee may, at
its own risk and without NIH prior approval, incur obligations and expenditures
to cover costs up to 90 days before the beginning date of the initial budget
period of the revision award if such costs: are necessary to conduct the
project, and would be allowable under the grant, if awarded, without NIH prior
approval. If specific expenditures would otherwise require prior approval, the
grantee must obtain NIH approval before incurring the cost. NIH prior approval
is required for any costs to be incurred more than 90 days before the
beginning date of the initial budget period of a new 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 http://grants1.nih.gov/grants/policy/nihgps_2003/index.htm.
6. Other Submission
Requirements
OVERVIEW
A revision application may be submitted to request support for an expansion of a project’s scope or research protocol. The Principal Investigator must be the same person as is the current Principal Investigator on the original application. A co-investigator may be designated as well. Applications for revision awards are not appropriate when the sole purpose is to restore awards, administratively reduced by the funding agency, to the full SRG-recommended level. A revision application will not be accepted until after the original application has been awarded, and may not extend beyond the term of the current grant. An Introduction is required to indicate how the revision is related to but also expands upon the original application.
Research Plan
The body of the application should contain sufficient information from the original grant application to allow evaluation of the proposal in relation to the goals of the original application. The regular Research Plan format should be followed but is limited to 10 pages. The research plan includes specific aims, background and significance, preliminary studies, and research designs and methods.
Also included within the 10 page limit, the research plan should cover the following items: These points should be included above where the Research Plan Is discussed.
Progress Report
A short progress report is required for revision applications and should be included in the 10 page limit. Provide the beginning and ending dates for the period covered since the project was last competitively reviewed. Summarize the previous application’s specific aims and the importance of the findings. Discuss any changes in the specific aims as a result of budget reductions for the current grant.
Appendix Materials
NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe these limitations may be delayed in the review process.
Foreign Applications (Non-domestic (non-U.S.) Entity)
Indicate how the proposed project has specific relevance to the mission and objectives of the IC and has the potential for significantly advancing the health sciences in the United States.
All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006
Plan for Sharing Research Data
While a plan for Sharing Research Data is not required, NIH encourages
applicants to consider the suitability of their research for data sharing. (http://grants.nih.gov/grants/policy/data_sharing).
The reasonableness of the data sharing plan or
the rationale for not sharing research data may be assessed by the reviewers.
However, reviewers will not factor the proposed data sharing plan into the
determination of scientific merit or the priority score.
Sharing Research Resources
NIH
policy expects that grant recipients make unique research resources readily
available for research purposes to qualified individuals within the scientific
community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each Non-Competing Grant
Progress Report (PHS 2590). See Section VI.3.,
Reporting.
Section V. Application Review Information
1. Criteria
Only the review criteria described below will be
considered in the review process.
2. Review and
Selection Process
Applications submitted for this funding opportunity
will be assigned to the IC of the parent grant on the basis of established Public Health Service (PHS) referral
guidelines.
Applications that are complete and responsive to the
FOA will be evaluated for scientific and technical merit by an appropriate peer
review group convened by the Center for Scientific Review in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.
Note that an application does not need to be strong in all
categories to be judged likely to have major scientific impact and thus deserve
a high priority score. For example, an investigator may propose to carry out
important work that by its nature is not innovative but is essential to move a
field forward.
Significance: Does this study address an
important problem? If the aims of the application are achieved, how will
scientific knowledge or clinical practice be advanced? What will be the effect
of these studies on the concepts, methods, technologies, treatments, services,
or preventative interventions that drive this field?
Approach: Are the conceptual or clinical
framework, design, methods, and analyses adequately developed, well integrated,
well reasoned, and appropriate to the aims of the project? Does the applicant
acknowledge potential problem areas and consider alternative tactics? For applications designating multiple PDs/PIs, does the Leadership Plan ensure that there will be sufficient
coordination and communication among the PDs/PIs? Are the administrative plans
for the management of the research project appropriate, including plans for
resolving conflicts?
Innovation: Is the project original and innovative? For example: Does
the project challenge existing paradigms or clinical practice; address an
innovative hypothesis or critical barrier to progress in the field? Does the
project develop or employ novel concepts, approaches, methodologies, tools, or
technologies for this area?
Investigators: Are the PD/PI(s)
and other key personnel appropriately trained
and well suited to carry out this work? Is the work proposed appropriate to the
experience level of the principal investigator and other researchers? Does the
PD/PI(s) and investigative team bring complementary and integrated expertise to
the project (if applicable)?
Environment: Do(es) the scientific environment(s) in which the work will
be done contribute to the probability of success? Do the proposed studies
benefit from unique features of the scientific environment, or subject
populations, or employ useful collaborative arrangements? Is there evidence of
institutional support?
2.A.
Additional Review Criteria:
In addition to the above criteria, the following items
will continue to be considered in the determination of scientific merit and the
priority score:
Protection
of Human Subjects from Research Risk: The involvement of human subjects and
protections from research risk relating to their participation in the proposed
research will be assessed. See the Human Subjects Sections of the PHS398
Research Plan component of the SF424 (R&R).
Inclusion of Women, Minorities and Children in Research: The adequacy of
plans to include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated. See the Human Subjects Sections of the PHS398
Research Plan component of the SF424 (R&R)
Care and Use of Vertebrate Animals in Research: If vertebrate animals
are to be used in the project, the adequacy of the plans for their care and use
will be assessed. See the Other Research Plan Sections of the PHS398 Research
Plan component of the SF424 (R&R).
Biohazards: If materials or procedures are proposed that are potentially
hazardous to research personnel and/or the environment, determine if the
proposed protection is adequate.
2.B. Additional Review Considerations
Budget and Period of Support: The reasonableness of the proposed budget and the
appropriateness of the requested period of support in relation to the proposed
research may be assessed by the reviewers. The priority score should not be
affected by the evaluation of the budget.
Applications from Foreign Organizations: Whether the project presents 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 will be assessed.
2.C.
Sharing Research Data
Not applicable.
2.D. Sharing Research
Resources
Program staff will be responsible for the
administrative review of the plan for sharing research resources.
The adequacy of the resources
sharing plan and any related data sharing plans will be considered by Program
staff of the funding organization when making recommendations about funding
applications. The effectiveness of the resource sharing will be evaluated as
part of the administrative review of each Non-Competing Grant
Progress Report (PHS 2590), See Section VI.3.,
Reporting.
Model Organism
Sharing Plan: Reviewers are
asked to assess the sharing plan in an administrative note. The sharing plan
itself should be discussed after the application is scored. Whether a sharing
plan is reasonable can be determined by the reviewers on a case-by-case basis,
taking into consideration the organism, the timeline, the applicant's decision
to distribute the resource or deposit it in a repository, and other relevant
considerations
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/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
Notice of Award (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 NoA and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of the award.
3. Reporting
When multiple years are involved,
awardees will be required to submit the Non-Competing Grant
Progress Report (PHS 2590) annually and financial statements as required in
the NIH
Grants Policy Statement..
Section
VII. Agency Contacts
We encourage your inquiries
concerning this funding opportunity and welcome the opportunity to answer
questions from potential applicants. Inquiries may fall into three areas:
scientific/research, peer review, and financial or grants management issues:
1. Scientific/Research
Contacts:
For general
information:
Ronald
P. Abeles, Ph.D.
Special
Assistant to the Director
Office
of Behavioral and Social Sciences Research
Office of the Director National Institutes of Health
Bldg. 31C, Rm. B1C19, MSC 2027
31
Center Drive
Bethesda, MD 20892-2027 (Courier Services Zip Code 20814)
Telephone:
301-496-7859
Fax:
301-435-8779
Email: [email protected]
Participating Components:
National Center for Complementary and Alternative Medicine (NCCAM) http://nccam.nih.gov/
Catherine
M. Stoney, Ph.D.
Health Scientist Administrator
National Center for Complementary
& Alternative Medicine
National Institutes of Health
6707 Democracy Blvd, Suite 401, MSC 5475
Bethesda, Maryland 20892-5475 (for express mail, use 20817)
Telephone.:(301) 402.1272
Fax:: (301) 480.3621
Email: [email protected]
National Institute of Child Health and Human Development (NICHD) http://www.nichd.nih.gov
Lisa
Freund, Ph.D.
Program Director, Developmental Cognitive Psychology, Behavioral Neuroscience,
and Psychobiology
Child Development and Behavior Branch
National Institute of Child Health and Human Development
6100 Executive Blvd
7510
Rockville, MD 20892-7510
Telephone: (301) 435-6879
Fax: (301) 480-0230
Email: [email protected]
National Institute of Dental and Craniofacial Research (NIDCR) http://www.nidcr.nih.gov
Ruth
Nowjack-Raymer, MPH, Ph.D
Director, Health Disparities Research Program
National Institute of Dental and Craniofacial Research
45 Center Drive, Building 45, Room 4AS-43F
Bethesda, MD 20892-6401
Tel.: (301) 594.5394
FAX: (301) 480.8322
Email: [email protected]
National Institute on Aging (NIA) http://www.nia.nih.gov
Erica
Spotts, Ph.D
Health
Scientist Administrator
Behavioral and Social Research Program
National Institute on Aging
7201 Wisconsin Avenue, Gateway 533
Bethesda, MD 20892
Telephone: (301) 496.3131
Fax: (301) 402.0051
Email: [email protected]
National
Institute on Alcohol Abuse and Alcoholism (NIAAA) http://www.niaaa.nih.gov/
Zhaoxia
Ren, MD, Ph.D.
Program
Director, Genetics
Genetics,
Division of Neuroscience and Behavior
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2063
Bethesda, MD 20892-9034
Telephone: (301) 443.5733
Fax: 301-443-1650
Email: [email protected]
National Institute of Dental and Craniofacial Research (NIDCR) http://www.nidcr.nih.gov
Ruth
Nowjack-Raymer, MPH, Ph.D
Director, Health Disparities Research Program
National Institute of Dental and Craniofacial Research
45 Center Drive, Building 45, Room 4AS-43F
Bethesda, MD 20892-6401
Telephone: (301) 594.5394
Fax: (301) 480-8322
Email: [email protected]
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) http://www.niddk.nih.gov/
Robert
Karp, Ph.D.
Program
Director, Genetics and Genomics
National Institute of Diabetes and Digestive and
Kidney Diseases
6706 Democracy Blvd., MSC 5450
Bethesda, MD 20892-5450
Telephone: (301) 451.8875
Fax: (301) 480.8300
Email: [email protected]
National Institute on Drug Abuse (NIDA) http://www.nida.nih.gov/
Kevin
Conway, Ph.D
Associate
Director
Division
of Clinical Neuroscience and Behavioral Research (DCNBR)
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5185, MSC 9589
Bethesda, MD 20892-9589
Telephone.:
(301) 402.1817
Email: [email protected]
National Institute of Mental Health (NIMH) http://www.nimh.nih.gov
Eve
K. Moscicki, Sc.D., MPH
Division of Pediatric Translation Research and
Treatment Development
National Institute of Mental Health
6001 Executive Boulevard, Room 6183, MSC 9617
Bethesda, MD 20892-9617
Telephone: (301) 443.5944
Fax: (301) 480.4415
Email: [email protected]
National Institute of Neurological Disorders and Stroke (NINDS) http://www.ninds.nih.gov
Margaret
Sutherland, Ph.D.
Program
Director
National Institute of Neurological Disorders and Stroke
Neuroscience Center, Room 2203
6001 Executive Blvd.
Bethesda, MD 20892
Telephone.:
(301) 496.5680
Fax: (301) 480.1080
Email: [email protected]
National Human Genome Research Institute (NHGRI) http://www.genome.gov
Jean
McEwen, JD, Ph.D.
Program Director, Ethical, Legal and Social Implications Research Program
National
Human Genome Research Institute
Division of Extramural Research
5635 Fishers Lane, Suite 4076 MSC 9305
Bethesda, MD 20892-9305
Telephone: (301)435.5585
Fax: (301) 480.2770
Email: [email protected]
2. Peer Review Contact(s):
Bob
Weller, Ph.D., Chief
Health of the Population (HOP) Integrated Review Group
Center for Scientific Review, NIH
6701 Rockledge Drive, Room 3136, MSC 7770
Bethesda, MD 20892 (20817 for overnight mail)
301-435-0694
301-480-1056
3. Financial/Grants Management Contact(s):
National Center for Complementary and Alternative Medicine (NCCAM) http://nccam.nih.gov/
George
Tucker
Grants Management Officer
National Center for Complementary and Alternative
Medicine
National Institutes of Health
6707 Democracy Blvd., Room 401, MSC 5475
Bethesda, MD 20892-5475
Telephone: (301) 594-9102
Fax:
(301) 480-3504
Email: [email protected]
National Institute on Aging (NIA) http://www.nia.nih.gov
John
Bladen
Grants Management Specialist
The National Institute on Aging
Grants and Contracts Management Office
Gateway Blvd., Suite. 2N212
7201 Wisconsin Avenue
Bethesda, MD 20902
Telephone: (301) 496.1472
Fax: (301) 402.3672
Email: [email protected]
National Institute on Alcohol Abuse and Alcoholism (NIAAA) http://www.niaaa.nih.gov/
Judy
Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3023
Bethesda, MD 20892-9034
Telephone: (301) 443.4704
Fax: (301) 443.3891
Email: [email protected]
National Institute of Child Health and Humand Development (NICHD) http://www.nichd.nih.gov
Bryan S.
Clark, M.B.A.
Chief Grants Management Officer
National Institute of Child Health and Human Development
6100 Executive Boulevard, 8A01, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-6975
Email: [email protected]
National Institute of Dental and Craniofacial Research (NIDCR) http://www.nidcr.nih.gov
Mary Daley
Chief Grants Management Officer
National Institute of Dental and Craniofacial Research
45 Center Drive, Building 45, Room 4AN-44B
Bethesda, MD 20892-6402
Telephone: (301) 594.4808
Fax: (301) 480.3562
Email: [email protected]
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) http://www.niddk.nih.gov
Robert
Pike
Chief, Grants Management Officer
National Institute of Diabetes & Digestive &
Kidney Diseases
National Institutes of Health
2 Democracy Plaza, MSC 5450
6707 Democracy Blvd., Room 731
Bethesda, MD 20892-5450
Telephone: (301) 594.8854
Fax: (301) 594.9523
Email: [email protected]
National Institute on Drug Abuse (NIDA) http://www.nida.nih.gov
Edith
Davis
Grants Management Branch
National Institute on Drug Abuse,
6101 Executive Boulevard, Room 270, MSC 8403
Rockville, MD 20852
Telephone: (301) 443.6710
Fax: (301) 594.6849
Email: [email protected]
National Institute of Mental Health (NIMH) http://www.nimh.nih.gov
Rebecca
Claycamp, CRA
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6122, MSC 9605
Bethesda, MD 20892-9605
Telephone:
(301) 443.2811
Fax:
(301) 443.6885
Email: [email protected]
National Institute of Neurological Disorders and Stroke (NINDS) http://www.ninds.nih.gov
Gavin
Wilkom
Grants Management Specialist
National Institute of Neurological Disorders and
Stroke
6001 Executive Blvd., MSC 9537
Bethesda, MD 20892-9537
Telephone.: (301) 496.7480
Fax: (301) 451.5635
Email: [email protected]
National Human Genome Research Institute (NHGRI) http://www.genome.gov
Cheryl
Chick
Scientific Review Branch/Grants Administration Branch
National Human Genome Research Institute, NIH
5632 Fishers Lane, Suite 4076, MSC 9306
Bethesda, MD 20892-9306
Telephone: (30) 435.7858
Fax: (301) 402.1951
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 IRB rules,
as well as local, State and Federal laws and regulations, including the Privacy
Rule. Reviewers will consider the data sharing plan but will not factor the
plan into the determination of the scientific merit or the priority score.
Access to Research Data through the Freedom of
Information Act:
The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide 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.
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.
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-02-005.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. Applications that do
not provide this information will be returned without review.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to
the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at
PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole or
in part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.
NIH is requesting that authors submit manuscripts
resulting from 1) currently funded NIH research projects or 2) previously
supported NIH research projects if they are accepted for publication on or
after May 2, 2005. The NIH Public Access Policy applies to all research grant
and career development award mechanisms, cooperative agreements, contracts,
Institutional and Individual Ruth L. Kirschstein National Research Service
Awards, as well as NIH intramural research studies. The Policy applies to
peer-reviewed, original research publications that have been supported in whole
or in part with direct costs from NIH, but it does not apply to book chapters,
editorials, reviews, or conference proceedings. Publications resulting from
non-NIH-supported research projects should not be submitted.
For more information about the Policy or the
submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/
and view the Policy or other Resources and Tools, including the Authors' Manual.
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 or Health
Systems Agency review. Awards are made under the authorization of Sections 301
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 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
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