Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
National Institute of Environmental Health Sciences (NIEHS), (http://www.niehs.nih.gov)
Fogarty International Center (FIC), (http://www.fic.nih.gov)
National Heart, Lung, and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov)
National Cancer Institute (NCI), (http://www.nci.nih.gov)
National Center on Minority Health and Health Disparities (NCMHD), (http://www.ncmhd.nih.gov)
National Institute on Aging (NIA), (http://www.nia.nih.gov)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov)
National Institute of Biomedical Imaging and Bioengineering (NIBIB), (http://www.nibib.nih.gov)
National Institute of General Medical Sciences (NIGMS), (http://www.nigms.nih.gov)
National Library of Medicine (NLM), (http://www.nlm.nih.gov)
Office of Behavioral and Social Sciences Research (OBSSR), (http://obssr.od.nih.gov)

Title: Climate Change and Health: Assessing and Modeling Population Vulnerability to Climate Change (R21)

Announcement Type
New

Update: The following updates relating to this announcement have been issued:

• August 16, 2010 - IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.
• September 29, 2010 (NOT-OD-11-007) - NIH to Require Use of Updated Electronic Application Forms in 2011.  Adobe B1 forms are required for due dates on or after May 8, 2011.
• August 3, 2010 - See Notice NOT-GM-10-107 This Notice is to inform potential applicants that the National Institute of General Medical Sciences (NIGMS) announces its participation in this FOA.

Program Announcement (PA) Number: PAR-10-235

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.113, 93.307, 93.399, 93.865, 93.866, 93.879, 93.989, 93.286, 93.837, 93.838

Key Dates
Release/Posted Date: July 21, 2010
Opening Date: August 28, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): August 28, 2010; April 24, 2011; April 24, 2012
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date(s): September 28, 2010; May 24, 2011; May 24, 2012
Peer Review Date(s): February 2011; October 2011, October 2012
Council Review Date(s): May 2011; January 2012; January 2013
Earliest Anticipated Start Date(s): July 1, 2011
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: May 25, 2012

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

• Purpose. This Funding Opportunity Announcement (FOA) is being issued by the National Institute of Environmental Health Sciences (NIEHS) of the National Institutes of Health (NIH) with participation from the following NIH components: FIC, NCI, NCMHD NHLBI, NIA, NIBIB, NICHD, NLM and OBSSR. This FOA encourages research applications to examine the differential risk factors of populations that lead to or are associated with increased vulnerability to exposures, diseases and other adverse health outcomes related to climate change. Applications may involve either applied research studies that address specific hypotheses about risk factors or population characteristics associated with increased vulnerability, or research projects to develop general models or methods for identifying and characterizing population vulnerability to climate change. The ultimate goal of this research program is to help inform climate change adaptation and public health interventions to reduce current and future vulnerability of various populations to the health effects of climate change. Applications are anticipated to involve a multidisciplinary research team, including experts in health sciences and climatology as well as geography, modeling, statistics, demography, and social and behavioral sciences as appropriate. In addition, partnerships with community-based or advocacy organizations, public health officials, urban planners and others are encouraged.
• Mechanism of Support. This FOA will use the NIH Exploratory/Developmental (R21) award mechanism.
• Funds Available and Anticipated Number of Awards. 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.
• Budget and Project Period. The total project period for an application submitted in response to this funding opportunity may not exceed 2 years. Direct costs are limited to $275,000 over an R21 2-year period, with no more than $200,000 in direct costs allowed in any single year.
• Application Research Strategy Length: The R21 Research Strategy section may not exceed 6 pages, including tables, graphs, figures, diagrams, and charts. See. See Table of Page Limits
• Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.
• Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
• Number of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application.
• Number of Applications. Applicants may submit more than one application, provided that each application is scientifically distinct.
• Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).
• Renewals. Exploratory/developmental grant support is for new projects only; competing renewal (formerly competing continuation ) applications will not be accepted.
• Special Date(s). This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates.
• Application Materials. See Section IV.1 for application materials.
• General Information. For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites:
  • SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm
  • General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/
• Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: (301) 451-5936

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
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 Contacts
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Purpose

This Funding Opportunity Announcement (FOA) is intended to support small research grants to examine the differential risk factors of populations that lead to, or are associated with increased vulnerability to exposures, diseases and other adverse health outcomes that are linked to or likely to result from climate change. The ultimate goal of the program is to identify specific characteristics of populations associated with vulnerability that can then be used to more effectively target and implement climate change responses and public health interventions. It is anticipated that the research projects will involve either 1) an applied study focused on specific populations, diseases, health outcomes, environmental exposures or events (e.g., extreme weather events) likely to be impacted by climate change; or 2) development of general methods or models to assess and characterize population variability to climate change that can be adapted to multiple population, health outcome/disease, or exposure scenarios.

Background

Global climate change is one of the most pressing environmental and public health concerns of the 21st century. Major human health impacts of climate change are anticipated to occur due to associated changes in the environment, such as direct effects from heat, sea level rise, changes in precipitation resulting in flooding and drought, more intense hurricanes and storms, degraded air quality and increased exposure to toxic environmental pollutants including persistent organic pollutants, metals, and pesticides. Strategies for mitigating and adapting to climate change also may have associated human health consequences, both beneficial and adverse. Therefore, a better understanding of how climate change will directly and indirectly alter human health risks in the United States and globally, and in particular, identification of those who will be most vulnerable to adverse health effects, is critical to reduce or prevent illness and death.

As the initial manifestations of global climate change have become more apparent, the federal government is accordingly expanding the focus of its research and development activities to include an increased emphasis on understanding, predicting, and responding to climate change impacts. Over the past year, several NIH Institutes, Centers and Offices (henceforth referred to as NIH Components ) have been involved in multiple activities to identify research needs on the human health impacts of climate change. In December 2009, a workshop was sponsored by the Trans-NIH Working Group on Climate Change and Health that brought leaders in the field together to help begin identifying priorities for NIH research in the context of climate change. The NIH also led an ad hoc Interagency Working Group on Climate Change and Health (IWGCCH) in developing a white paper that outlines research needs for eleven categories of consequences of climate change for human health, including asthma and respiratory disease, cancer, cardiovascular disease and stroke, foodborne diseases and nutrition, human developmental effects, mental health and stress-related disorders, neurological diseases, vectorborne and zoonotic diseases, waterborne diseases, and weather-related morbidity and mortality. This report is available online at: www.niehs.nih.gov/climatereport. Research to assess and characterize population vulnerability to adverse health impacts due to climate change was identified as a significant need and opportunity at the December 2009 workshop and as a crosscutting theme in the IWGCCH white paper.

Understanding the different risks experienced by affected populations is key to effectively targeting and implementing climate change adaptation and public health intervention efforts. Adaptation is needed now to reduce current vulnerability to climate change as well as to address the potential health risks projected to occur over the coming decades. A number of populations may be at particular risk. These include children, pregnant women, the elderly, individuals from low socio-economic backgrounds, and individuals living in urban or coastal areas and storm centers. However, data and models to support even these broad predictions are generally lacking at this time. In particular, there are significant gaps in understanding of vulnerabilities among populations residing in low and middle-income countries (LMICs).

For purposes of this FOA, vulnerability is broadly defined to include intrinsic biological factors that can increase the health risk of an individual at a given exposure level, as well as environmental, behavioral, social or personal factors that increase climate sensitivity. Intrinsic biological factors include characteristics such as life-stage (infancy, childhood, elderly), pregnancy, and underlying disease status. Environmental or personal factors that may increase sensitivity include poverty, substance abuse, geographic location, population displacement, and disproportionate exposure to environmental contaminants likely to be exacerbated by climate change (e.g., air pollution). Vulnerable populations and regions generally have less ability to respond to stresses imposed by climate variability and change and are more likely to suffer harm.

Objectives and Scope

The overall objective of this FOA is to promote protection of populations at greatest risk of climate-related health impacts by identifying the factors that convey vulnerability and informing the implementation of adaptive strategies in health care, emergency services, land use, urban design and settlement patterns. Research projects will fall into one of two major categories:

1) Applied studies (e.g., demographic and observational epidemiological studies using existing data, applied predicative modeling projects, projects utilizing system science approaches, etc.) that are focused on specific populations, diseases, outcomes, or environmental exposures or events (e.g., extreme weather events) likely to be impacted by climate change.

2) General methods and model development that can be adapted to multiple population, health, disease, or exposure scenarios.

The scope of applications submitted under these two categories is discussed in more detail below. Under both categories, applications that take into consideration not only current impacts of climate and weather variability on health but also consider projected health impacts and associated vulnerabilities under future scenarios (including both changes in climatic and non-climatic parameters, such as population age structure, population density, and population distribution) are particularly encouraged. All applications should include health scientist(s) and climatologist(s) on the research team; however, it also is anticipated that competitive applications will include a more diverse multidisciplinary team, to include expertise in areas such as geography, mathematical modeling, economics, demography, and social and behavioral sciences, as appropriate for the scope of the application. In addition, because the ultimate goal of this research is to identify vulnerable populations and inform climate change interventions, applicants are encouraged to partner with community-based or advocacy organizations, public health officials, health professionals, policy-makers, urban planners, and others as appropriate to help inform the development of research questions and translation and dissemination of research findings.

Applied Modeling Studies of Population Vulnerability

Data to support a broad understanding of how climate change affects populations and which populations are most vulnerable to negative health outcomes affected by climate change are generally lacking at this time. Grant applications submitted under this category must directly address specific hypotheses about risk factors or characteristics of a population associated with increased vulnerability to health impacts due to global climate change. Such projects may be focused around a variety of topics, including, but is not limited to:

• Vulnerability to a range of health impacts of specific populations defined by characteristics such as age, sex, reproductive status, health status, socio-economic status, or geographic region (e.g., children, pregnant women, the elderly; individuals with other underlying diseases; individuals from low socio-economic backgrounds; individuals living in vulnerable urban or coastal areas; individuals that engage in risky behaviors like drug use or subsistence fishing, etc.).
• Specific health outcomes of interest (e.g., respiratory illnesses, heat-related morbidity, human developmental outcomes, vector borne and zoonotic diseases, mental health outcomes, etc.) as well as specific demographic outcomes, such as mortality, morbidity and fertility.
• Specific exposures directly or indirectly impacted by climate change that are also likely to be associated with human health (e.g., heat; air quality; extreme weather events; exposure to toxic environmental pollutants including persistent organic pollutants, metals, and pesticides; etc.).

Given the limited scope of the R21 mechanism, it is anticipated that most applications will rely mainly on using existing data sources to address research questions as opposed to collection of primary data. However, a small amount of primary data collection, for example to validate existing data sources, is allowable as long as such activity can be contained within the time and cost limitations of this FOA. It is also anticipated that most proposals will focus on local-to-regional scale data, as demography, climate vulnerability, and adaptation strategies will differ between cities and regions. However, there may be value in defining common principles that are valid on a larger scale (e.g., national or international) and for multiple populations as well. Applicants should justify the spatial scale (local, regional, national, international) as well as the temporal scale of the proposed project according to the specific hypothesis to be addressed. In addition, applicants should include a description of how the proposed project will help inform possible interventions or responses to health impacts of climate change.

General Methods and Model Development Projects

Identification and collection of integrated and appropriately scaled climate/weather data with demographic, social, economic, ecological, geographic and epidemiological data is needed for effective modeling of the human health impacts of climate change, including factors that influence population vulnerability. However, at present, methods for integrating such datasets with weather and climate information are not well established. Grant applications submitted under this category are anticipated to propose the development of generic methods, models or tools for identifying and characterizing population vulnerability to global climate change. Rather than focus on specific hypotheses, such projects will aim to develop general strategies that could be applied to multiple populations, diseases/health outcomes, environmental exposures or events relevant to climate change. Projects may be focused on the local, regional, national, or international level, but should not be targeted to a select population. In addition, applicants should provide a description of how the proposed new method, model or tool can be used by relevant stakeholders to inform possible interventions or responses to health impacts of climate change.

Specific Research Interests and Expectations of NIH Components

Specific examples of research topics of interest of participating NIH Components are outlined below.

National Institute of Environmental Health Sciences:

NIEHS encourages applications focused on assessing and characterizing population vulnerability linked to environmental health issues associated with climate change. Climate change is likely to affect human exposure to a number of known and suspected environmental hazards, leading to downstream health impacts that are likely to have a greater impact on some populations than others. For example, changes in air quality associated with climate change (e.g., increases in exposure to air pollutants including toxic chemicals, fungi, and aeroallergens) are likely to result in increases in asthma, cardiovascular disease, and other respiratory illnesses. Certain populations (e.g., those residing in urban locations, individuals with underlying chronic disease, children, and the elderly) may be more vulnerable to these health impacts than others. Climate change may lead to increased pesticide and herbicide exposure due to the need to combat climate-induced increases in pests, combined with increases in precipitation intensity resulting in toxic runoff and subsequent water contamination. At the same time, changes in rainfall and other precipitation, extreme weather events, and melting of polar ice caps also may result in increased exposure to toxic environmental pollutants such as persistent organic pollutants and metals. Many of these chemicals are known or suspected carcinogens and can also cause a variety of developmental or neurological effects. This has implications for identifying those populations that may be at greatest risk and informing potential environmental health interventions. Specific examples of research projects of interest to NIEHS under this FOA include, but are not limited to:

• Research to identify and map populations and communities at increased risk of specific climate-related diseases (e.g., heat-related morbidity and mortality, respiratory illness, etc.) in relation to climate-related changes in air quality and other social stressors that may influence risk of such health outcomes.
• Research to examine the impacts of climate change (e.g., heavy precipitation, flooding, and coastal inundation) on the risk of toxic contamination of the environment (e.g., from storage facilities, indoor mold growth associated with flooding/moisture, inundation of hazardous waste sites, or runoff from land containing toxic chemicals) to identify populations most likely to be impacted and potential health effects.
• Research to better understand how anticipated changes in nutritional status associated with climate change will coincide with possible changes in environmental exposures and may increase individual susceptibility to the adverse health impacts of concomitant changes in exposure to environmental toxicants (e.g., increased exposure to pesticides and heavy metals).
• Research to better understand the environmental conditions and concomitant behaviors (recreational water use, consumption of seafood) that may increase individual risk to climate change-related increases in exposure to harmful algal blooms.
• Community-based research involving community organizations, environmental health scientists, climatologists, geographers, and community planners to determine and prioritize the greatest climate-related risk for a given community, with a particular focus on anticipated environmental changes, to facilitate allocation of resources for adapting to and mitigating climate change.
• Research to develop general methods or models for identifying and understanding local vulnerabilities and needs for anticipated climate-related changes in the environment and associated health effects that can be applied across multiple populations.

Applications submitted under this FOA focusing on vector-borne zoonotic diseases or waterborne pathogens alone (i.e., outside the context of interactive effects with environmental toxins) will not be considered high priority for NIEHS.

Fogarty International Center:

The Fogarty International Center encourages applications that focus on vulnerable populations in low- and middle-income countries, especially in Africa. Disease areas of interest include those that present the greatest burden of disease today and/or in the future and likely to have the greatest sensitivity to climate. Projects that address multiple interacting influences on population health including, not only biology and climate, but also features of socioeconomic status, public health infrastructure and/or access to healthcare are a high priority for FIC.

FIC encourages all applicants for research grants in global health to collaborate actively with host country partners and include research capacity enhancement in the design and conduct of proposed research.

National Cancer Institute:

NCI encourages applications with the ability to incorporate long time spans to assess the impact of climate changes on cancer incidence through established physical, chemical, or infectious agents that may differentially impact populations due to their geographic location, genotype, and/or developmental windows of susceptibility. Specific examples of research projects of interest to NCI under this FOA include, but are not limited to:

• Vulnerability due to geographic location. Research using agent-based modeling to identify populations living in certain geographic locations for increased cancer incidence due to climate-induced changes in exposure to ultraviolet (UV) radiation, Helicobacter Pylori infections, or behavioral risk factors.
• Vulnerability due to genotype. Research modeling prevalence of C-C chemokine receptor type 5 (CCR5) variants and risk of HIV infection with subsequent Kaposi’s sarcoma.
• Vulnerability due to developmental windows of susceptibility. Research estimating climate-change-induced increases in endocrine disruptor exposures among pubertal females and subsequent breast and reproductive cancers.

National Center on Minority Health and Health Disparities:

NCMHD encourages applications that propose to expand and/or enhance research innovation critical for understanding the impact of climate change on human health and development, in order to assist health disparity populations mitigate and adapt to the environmental effects in the most competent and healthiest way.

• NCMHD encourages applications that propose transdisciplinary approaches, and where possible, involve vulnerable communities in all aspects of the planning, design, development and implementation. In doing so, the research needs to consider the host of factors that come into play in determining vulnerability, such as social, economic, behavioral and cultural determinants, geographic factors, public policies, biological susceptibility and the built environment.
• NCMHD will also support relevant cross-cutting research such as health communication and information dissemination research needed to effectively implement climate change responses and interventions within health disparity populations. Partnerships with community and faith-based organizations are encouraged.

National Institute on Aging:

NIA encourages applications using the methods of the behavioral and social sciences, such as epidemiology, economics, social demography, and agent-based modeling; for applied modeling studies of effects of climate change on health of age-structured populations, with particular interests in effects of heat and extreme weather events.

National Institute of Biomedical Imaging and Bioengineering:

NIBIB is interested in supporting the development of novel modeling, analysis, and simulation technology for identifying and characterizing population vulnerability to climate change. In particular NIBIB is interested in promoting the development of predictive multiscale models in this area. Interested investigators are encouraged to participate in the Interagency Modeling and Analysis Group (IMAG) Multiscale Modeling (MSM) Consortium, www.imagwiki.org/mediawiki.

Eunice Kennedy Shriver National Institute of Child Health and Human Development:

NICHD interests include, but are not limited to:

• Research on the effects of climate change on population dynamics such as fertility, mortality and morbidity, and population movement, distribution, and composition.
• Research on identifying sub-populations that are especially vulnerable to the effects of global warming that takes a population-based demographic or economic approach, using scientifically valid probability samples.
• Research on the effects of climate change on reproduction; infertility; and maternal, prenatal, and child health; child development; and disability.
• Research on the effects of climate change on the incidence and prevalence of HIV/AIDS, tuberculosis, malaria, and other infectious diseases.
• Research on interactions between climate change and land use and their effects on population dynamics and population health.
• Research on the effects of climate change on the ecology of consumable food products and their influence on childhood diseases such as asthma, food allergy, and changes in the developmental immune system.
• Research on the effects of climate change on bacterial genome and the potential impact of changes in the bacterial genome on infectious conditions in immune compromised hosts.

National Library of Medicine:

The National Library of Medicine (NLM) is interested in novel informatics approaches that support the goal of assessing and modeling population vulnerability to climate change. Examples include, but are not limited to:

• Approaches to merging data from disparate sources (e.g., satellite imagery with genomic or phenomic data) to provide a more complete picture of the relationships between climate and disease for a specific population, location or health condition.
• Novel data mining approaches for discovering, visualizing and testing hypotheses about climate effects on particular diseases or population groups.
• Advanced applications of computational intelligence to support information integration, minimizing the human intervention needed to map and standardize data elements in large health, demographic or climate data sets.
• Analysis of the role access to timely, relevant information plays in a population s vulnerability to climate change.
• Informatics for bio- surveillance and dynamic mapping of diseases sensitive to climate change.

Administrative Requirements

To encourage applicants to share information gained via these grants, at least one member of each awarded project may be asked to attend an annual meeting in the Washington, DC area. Applicants should include such travel in their budget requests. In addition, applicants may be asked to participate in periodic webinars and conference calls to facilitate grantee interaction and exchange of knowledge.

The R21 mechanism is intended to encourage new exploratory and developmental research projects. By using the R21 mechanism, the NIH seeks to foster the introduction of novel scientific ideas, model systems, tools, and technologies that have the potential to substantially advance biomedical, behavioral, clinical, or public health research. These studies should break new ground or extend previous discoveries toward new directions or applications. In particular, this FOA encourages research projects that will produce new information, models and analytic approaches to help inform climate change intervention and adaption strategies to reduce current vulnerability to the climate change as well as address the potential health risks projected to occur over the coming decades.

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

Section II. Award Information

1. Mechanism of Support

This FOA will use the NIH Exploratory/Developmental Research Grant (R21) award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses Just-in-Time information concepts see SF424 (R&R) Application Guide). It also uses modular as well as non-modular budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, Modular Budget Component, of the Application Guide).

All foreign applicants must complete and submit budget requests using the Research & Related Budget component.

2. Funds Available

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 Institutes and Centers (ICs) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

The total project period for an application submitted in response to this funding opportunity may not exceed 2 years. Although the size of award may vary with the scope of research proposed, it is expected that applications will stay within the budgetary guidelines for an exploratory/developmental project; direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year award period. 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.

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

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education
• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Small Businesses
• For-Profit Organizations (Other than Small Businesses)
• State Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribally Designated Organizations
• County Governments
• City or Township Governments
• Special District Governments
• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• U.S. Territory or Possession
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Organizations)
  • Other(s): Eligible Agencies of the Federal Government
  • Faith-based or Community-based Organizations.

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://grants.nih.gov/grants/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 the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

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 that each application is scientifically distinct.

Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and renewal applications are permitted only a single amendment (A1). See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and NOT-OD-09-016. Original new and renewal applications that were submitted prior to January 25, 2009 are permitted two amendments (A1 and A2). For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.

Renewals. Exploratory/developmental grant support is for new projects only; renewal (formerly competing continuation ) applications will not be accepted.

Section IV. Application and Submission Information

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the Apply for Grant Electronically button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered on-time (see 3.C.1 for more information about on-time submission).

A one-time registration is required for institutions/organizations at both:

• Grants.gov (http://www.grants.gov/applicants/get_registered.jsp) and
• eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm)

PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.

Several additional separate actions are required before an applicant can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Registered.

• Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
• If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
• The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
• Direct questions regarding Grants.gov registration to:
  Grants.gov Customer Support
  Contact Center Phone: 800-518-4726
  Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
  Email [email protected]

2) Organizational/Institutional Registration in the eRA Commons

• To find out if an organization is already Commons-registered, see the "List of Grantee Organizations Registered in NIH eRA Commons.
• Direct questions regarding the Commons registration to:
  eRA Commons Help Desk
  Phone: 301-402-7469 or 866-504-9552 (Toll Free)
  TTY: 301-451-5939
  Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
  Email [email protected]

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

• The individual designated as the PD/PI on the application must also be registered in the NIH eRA Commons. It is not necessary for PDs/PIs to register with Grants.gov.
• The PD/PI must hold a PD/PI account in the Commons and must be affiliated with the applicant organization. This account cannot have any other role attached to it other than the PD/PI.
• This registration/affiliation must be done by the Authorized Organization Representative/Signing Official (AOR/SO) or their designee who is already registered in the Commons.
• Both the PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

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 SF424 (R&R) application forms for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget or Research & Related Budget, as appropriate (See Section IV.6. regarding appropriate required budget component.)

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

Foreign Organizations (Non-domestic [non-U.S.] Entities)

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:

• Request budgets in U.S. dollars;
• Prepare detailed budgets for all applications (that is, complete the Research & Related Budget component of the SF424 (R&R) application forms not the PHS398 Modular Budget component)(see NOT-OD-06-096);
• Not include any charge-back of customs and import fees;
• Comply with the format specifications, which are based upon a standard U.S. paper size of 8.5 x 11 within each PDF;
• If appropriate, request funds for up to 8% Facilities and Administrative (F&A) costs (excluding equipment) ( see NOT-OD-01-028, March 29, 2001);
• Comply with Federal/NIH policies on human subjects, animals, and biohazards; and
• Comply with Federal/NIH biosafety and biosecurity regulations (see Section VI.2., Administrative and National Policy Requirements )

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 (U.S.) or that augment existing U.S. resources.

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs

When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the Contact PD/PI should be entered on the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

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

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

Applications Involving a Single Institution

When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

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
Opening Date: August 28, 2010 (Earliest date an application may be submitted to Grants.gov)
Letter of Intent Receipt Date(s): August 28, 2010; April 24, 2011; April 24, 2012
Application Due Date(s): September 28, 2010; May 24, 2011; May 24, 2012
Peer Review Date(s): February 2011; October 2011, October 2012
Council Review Date(s): May 2011; January 2012; January 2013
Earliest Anticipated Start Date(s): July 1, 2011

3.A.1. Letter of Intent

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

• Descriptive title of proposed research.
• Name, address, and telephone number of the PD(s)/PI(s).
• Names of other key personnel.
• Participating institutions.
• Number and title of this funding opportunity.

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:

Caroline H. Dilworth, PhD
Susceptibility and Population Health Branch
Division of Extramural Research and Training
Nation Institute of Environmental Health Sciences
P.O. Box 12233, K3-12
111 T.W. Alexander Drive
Research Triangle Park, NC 27709-2233
Telephone: (919) 541-7727
FAX: (919) 316-4606
Email: [email protected]

Please note that electronic submission via email is preferred.

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow Steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

3.C. Application Processing

3.C.1 Submitting On-Time

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered on-time :

• All registrations must be complete prior to the submission deadline
• The application must receive a Grants.gov tracking number and timestamp (or eRA help desk ticket confirming a system issue preventing submission) by 5:00 p.m. local time on the submission deadline date.
• Any system identified errors/warnings must be corrected and the submission process completed within the error correction window.

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.

Please note that the following caveats apply:

• Initial application submission must be on-time.
• The AOR/institutions is expected to enforce that application changes made within the error correction window are restricted to those necessary to address system-identified errors/warnings. NIH may reject any application that includes additional changes.
• Proof of on-time submission (e.g., Grants.gov timestamp and tracking number) and description of all changes made within the window must be documented in the PHS 398 Cover Letter component of the application.

3.C.3 Viewing an Application in the eRA Commons

Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.

• If everything is acceptable, no further action is necessary. The application will automatically move forward to the Division of Receipt and Referral in the Center for Scientific Review for processing after two weekdays, excluding Federal holidays.
• Prior to the submission deadline, the AOR/SO can Reject the assembled application and submit a changed/corrected application within the two-day viewing window. This option should be used if it is determined that some part of the application was lost or did not transfer correctly during the submission process, the AOR/SO will have the option to Reject the application and submit a Changed/Corrected application. In these cases, please contact the eRA Help Desk to ensure that the issues are addressed and corrected. Once rejected, applicants should follow the instructions for correcting errors in Section 2.12 of the SF 424 (R&R) application guide, including the requirement for cover letters on late applications. The Reject feature should also be used if you determine that warnings are applicable to your application and need to be addressed now. Remember, warnings do not stop further application processing. If an application submission results in warnings (but no errors), it will automatically move forward after two weekdays if no action is taken. Some warnings may need to be addressed later in the process.
• If the two-day window falls after the submission deadline, the AOR/SO will have the option to Reject the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn t transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue.
• If the AOR/SO chooses to Reject the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted, but it will be subject to the NIH late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment.
• Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two weekdays.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.

The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: 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.

6. Other Submission Requirements

Administrative Requirements

To encourage applicants to share information gained via these grants, at least one member of each awarded project may be asked to attend an annual meeting in the Washington, DC area. Applicants should include such travel in their budget requests. In addition, applicants may be asked to participate in periodic webinars and conference calls to facilitate grantee interaction and exchange of knowledge.

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD/PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Registration FAQs Important Tips -- Electronic Submission of Grant Applications.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

PHS398 Research Plan Component Sections

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following requirements for R21 applications:

• Introduction (required for a resubmission) is limited to 1 page.
• Specific Aims is limited to 1 page.
• Research Strategy, including tables, graphs, figures, diagrams, and charts, is limited to 6 pages. See Table of Page Limits.
• Preliminary data are not required but may be included if available.

Budget Component

U.S. applicants submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs) must use the PHS398 Modular Budget component.

All foreign applicants must complete and submit budget requests using the Research & Related Budget component.

R21 applications will use the modular as well as non-modular budget formats and "Just-in-Time" information concepts, with direct costs requested in $25,000 modules, up to the total direct costs limitation of $275,000 over an R21 two-year period. No more than $200,000 in direct costs will be allowed in any single year. All foreign applicants must complete and submit requests using the Research & Related Budget component.

Appendix Materials

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm). Also see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.

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

Resource Sharing Plan(s)

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

(a) Data Sharing Plan: Not Applicable

(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 (e.g., blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (go to NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.)

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

Indicate how the proposed project has specific relevance to the mission and objectives of the NIH/IC and has the potential for significantly advancing the health sciences in the United States.

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 submitted for this funding opportunity will be assigned on the basis of established PHS referral guidelines to the ICs for funding consideration.

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

As part of the initial merit review, all applications will:

• Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned an overall impact/priority score;
• Receive a written critique; and
• Receive a second level of review by an appropriate advisory council or board.

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

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? Will research findings or products from the project help inform climate change adaptation and intervention activities to reduce current and future vulnerability of specific populations to climate change? Does the project address an issue currently associated with high burden of disease or likely to be associated with high burden of disease in the future?

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? Does the research team include expertise in health sciences and climatology? Do the research team include other relevant expertise appropriate for the scope of the applications, such as geography, mathematical modeling, economics, demography, and social and behavioral sciences?

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? Will the project produce new research findings or new methods/models/tools that will provide information or enable analysis that will help fill existing gaps in our understanding of the different risks experienced by various exposed or affected populations in relation to climate change?

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?

For methods, models or tool development projects, is it likely that new strategies proposed can be adapted to multiple population, disease, or exposure scenarios?

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. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewal Applications. Renewal applications will not be accepted under this FOA.

Revision Applications. Revision applications will not be accepted under this FOA.

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. As applicable for the FOA or submitted application, 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 (Not Applicable); 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

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

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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 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.

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.

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

Section VII. Agency Contacts

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

1. Scientific/Research Contacts:

National Institute of Environmental Health Sciences (NIEHS)

Caroline H. Dilworth, PhD
Program Administrator
Susceptibility and Population Health Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, K3-12
111 T.W. Alexander Drive
Research Triangle Park, NC 27709-2233
Telephone: (919) 541-7727
FAX: (919) 316-4606
Email: [email protected]

Fogarty International Center (FIC)

Joshua Rosenthal, Ph.D.
Deputy Director
Division of International Training and Research
Fogarty International Center
31 Center Drive, Room B2C39
Bethesda, MD 20892-2220
Telephone: (301)496-1653
Fax: (301)402-0779
Email: [email protected]

National Cancer Institute (NCI)

Britt C. Reid, DDS, PhD
Chief
Modifiable Risk Factors Branch
Epidemiology and Genetics Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
Executive Plaza North, Room 5134
6130 Executive Blvd, MSC 7324
Bethesda, MD 20892-7324
Telephone: (301)435-4914
FAX: (301)402-4279
Email: [email protected]

National Center on Minority Health and Health Disparities (NCMHD)

Irene Dankwa-Mullan, MD, MPH.
Director
Office of Innovation and Program Coordination
National Center on Minority Health and Health Disparities
6707 Democracy Blvd. Suite 800
Bethesda, MD 20892-5465
Telephone: (301) 594-8758
FAX: (301) 480-4049
Email: [email protected]

National Heart, Lung, and Blood Institute (NHLBI)

Lawrence Fine, PhD, MD
Division of Cardiovascular Sciences
National Heart Lung and Blood Institute
6701 Rockledge Drive
Bethesda, MD 20892-7936
TelepPhone: (301) 435-0305
Fax: (301) 480-1455
Email: [email protected]

National Institute on Aging (NIA)

John G. Haaga, PhD
Deputy Director
Division of Behavioral and Social Research
National Institute on Aging
Gateway Building, Suite 533
7201 Wisconsin Avenue
Bethesda, MD 20892
Telephone: (301) 496-3131
FAX: (301) 402-0051
Email: [email protected]

National Institute of Biomedical Imaging and Bioengineering:

Grace C.Y. Peng, Ph.D.
Interagency Modeling and Analysis Group (IMAG) http://www.nibib.nih.gov/Research/MultiScaleModeling/IMAG
Program Director
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Boulevard, Suite 200, MSC 5477
Bethesda, MD 20892-5477
Telephone: (301) 451-4778
Fax: (301) 480-1614
Email: [email protected]

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Rebecca L. Clark, Ph.D.
Acting Chief
Demographic and Behavioral Sciences Branch
Center for Population Research
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Blvd
Room 8B07, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-1175
Fax: (301) 496-0962
E-mail: [email protected]

National Library of Medicine (NLM)

Jane Ye, Ph.D.
Program Officer,
NLM Extramural Programs
National Library of Medicine
6705 Rockledge Drive
Rockledge 1, Suite 301
Bethesda, MD 20892
Telephone: (301) 594-4927
FAX: (301) 402-2952
Email: [email protected]

2. Peer Review Contacts:

Katherine N. Bent, R.N., Ph.D., C.N.S.
Chief
Healthcare Delivery and Methodologies Integrated Review Group
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, MSC 7770
Bethesda, MD 20892
Telephone: (301) 435-0695
FAX: (301) 408-1056
Email: [email protected]

3. Financial or Grants Management Contacts:

National Institute of Environmental Health Sciences (NIEHS)

Barbara Gittleman
Grants Management Specialist
Grants Management Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
111 T.W. Alexander Drive, MSC K3-11
Research Triangle Park, NC 27709-2233
Telephone: (919) 541-0585
Fax: (919) 541-2860
Email: [email protected]

Fogarty International Center (FIC)

Elizabeth Cleveland
Grants Management Specialist
Fogarty International Center
National Institute of Health
Building 31, Room B2C29
Bethesda, MD 20892-2220
Telephone: (301) 496-5710
Fax: (301) 451-6830
Email: [email protected]

National Cancer Institute (NCI)

Carol Perry
Branch Chief
Office of Grants Management
National Cancer Institute
6120 Executive Boulevard, Suite 243
Bethesda, MD 20892
Telephone: (301) 496-7205
Fax: (301) 496-8601
Email: [email protected]

National Center on Minority Health and Health Disparities (NCMHD)

Priscilla Grant, J.D., C.R.A.
Chief
Grants Management Officer
National Center on Minority Health and Health Disparities
National Institutes of Health
6707 Democracy Boulevard, Suite 800
Bethesda, Maryland 20892-5465
Telephone: (301) 594-8412
Fax: (301) 480-4049
Email: [email protected]

National Heart Lung and Blood Institute (NHLBI)

Denise Payne
Grants Management Specialist
Office of Grants Management
National Heart Lung and Blood Institute
6701 Rockledge Drive
Bethesda, MD 20892-7926
Phone: (301) 594-9529
Fax: (301) 451-5462
Email: [email protected]

National Institute on Aging (NIA)

John Bladen
Grants Management Specialist
The National Institute on Aging
Grants and Contracts Management Office
Gateway Bld., Ste. 2N212
7201 Wisconsin Avenue
Bethesda, MD 20902
FedEx use 20814
Telephhone: (301) 402-7730
Fax: (301) 402-3672
Email: [email protected]

National Institute of Biomedical Imaging and Bioengineering:

Nancy Curling
Chief Grants Management Officer
National Institute of Biomedical Imaging and Bioengineering, NIH
6707 Democracy Blvd., MSC 5469
Suite 900, Democracy II
Bethesda, MD 20892-5469
Telephone: (301) 451-4782
Fax: (301) 480-4974
Email: [email protected]

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Bryan S. Clark, M.B.A.
Chief Grants Management Officer
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 8A01, MSC 7510
Bethesda, MD 20892
Telephone: (301) 435-6975
FAX: (301) 402-0915
Email: [email protected]

National Library of Medicine (NLM)

Dwight Mowery
Grants Management Officer
NLM Extramural Programs
6705 Rockledge Drive
Rockledge 1, Suite 301
Bethesda, MD 20892
Telephone: (301) 496-4221
FAX: (301) 402-0421
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

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

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

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

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

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

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

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

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

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

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

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

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

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

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

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

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

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