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     
Office of Behavioral and Social Sciences Research (OBSSR) (http://obssr.od.nih.gov)
National Cancer Institute (NCI) (http://www.nci.nih.gov)
National Center for Complementary and Alternative Medicine (NCCAM) (http://www.nccam.nih.gov)
National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov)
National Human Genome Research Institute (NHGRI) (http://www.genome.gov)
National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov)
National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov)
National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov)
National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov)
National Institute of Nursing Research (NINR) (http://www.ninr.nih.gov/)
National Institute on Aging (NIA) (http://www.nia.nih.gov)
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov)
National Institute on Arthritis, Musculoskeletal, and Skin Diseases (NIAMS) (http://www.niams.nih.gov)
National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov)
National Institute on Deafness and Other Communications Disorders (NIDCD) (http://www.nidcd.nih.gov)  

Title:  Social and Cultural Dimensions of Health (R01)

Announcement Type
This is a conversion for electronic submission of PA-05-029, which was previously released on December 17, 2004.

Update: The following update relating to this announcement has been issued:

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 weeks prior to the grant submission date. See Section IV.

Program Announcement (PA) Number: PA-07-045

Catalog of Federal Domestic Assistance Number(s)
93.399, 93.213, 93.397, 93.172, 93.866, 93.273, 93.846, 93.929, 93.121, 93.279, 93.847, 93.848, 93.849, 93.113, 93.114, 93.115, 93.242, 93.361, 93.173  

Key Dates:
Release/Posted Date: November 21, 2006
Opening Date:  January 5, 2007 (Earliest date an application may be submitted to Grants.gov).
Letters of Intent Receipt Date(s):Not applicable
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 Submission/Receipt Date(s):  Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm  
AIDS Application Submission/Receipt Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward 
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: January 3, 2008 (now January 8, 2008 per NOT-OD-07-093) .

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives


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

Section III. Eligibility Information
1. Eligible Applicants

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

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. 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
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices

2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency 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

The ultimate goal of this program announcement is to encourage the development of health research that integrates knowledge from the biomedical and social sciences. This involves the further development of health-related social science research relevant to the missions of the NIH Institutes and Centers (ICs) and the development of multi- or inter-disciplinary research that blends the theories and approaches of the social and biomedical sciences. Within the broad spectrum of research identified in this announcement, applicants are encouraged (but are not required) to employ multiple (i.e., biological, behavioral, and/or social) levels of analysis.

This announcement invites applications to (a) elucidate basic social and cultural constructs and processes used in health research (b) clarify social and cultural factors in the etiology and consequences of health and illness (c) link basic research to practice for improving prevention, treatment, health services, and dissemination, and (d) explore ethical issues in social and cultural research related to health.

This program announcement is a conversion and revision of PA-02-043 and is based upon recommendations submitted to the NIH in conjunction with the conference entitled Toward Higher Levels of Analysis: Progress and Promise in Research on Social and Cultural Dimensions of Health , June 27-28, 2000, Bethesda, MD. For a summary of the conference, see http://obssr.od.nih.gov/Documents/Conferences_And_Workshops/HigherLevels_Final.PDF. Also see “Social Science and Health Research: Growth at the NIH,” American Journal of Public Health, 94, 1, Jan. 2004: 22-28.You may request these publications from the Office of Behavioral and Social Sciences Research, Office of the Director, National Institutes of Health, Bethesda, MD 20892.

Social scientists have made significant strides in shedding light on the basic social and cultural structures and processes that influence health. Social and cultural factors influence health by affecting exposure and vulnerability to disease, risk-taking behaviors, the effectiveness of health promotion efforts, and access to, availability of, and quality of health care. Social and cultural factors also play a role in shaping perceptions of and responses to health problems and the impact of poor health on individuals' lives and well-being. In addition, such factors contribute to understanding societal and population processes such as current and changing rates of morbidity, survival, and mortality.

Numerous reports from the Institute of Medicine and National Research Council have pointed to the importance of social and cultural factors for health and the opportunities for improving health through a better understanding of mechanisms linking the social and cultural environment to specific health outcomes. To realize these opportunities, social science research related to health must be further developed and ultimately integrated into interdisciplinary, multi-level studies of health. Linking research from the macro-societal levels, through behavioral and psychological levels, to the biology of disease will provide the integrative health research necessary to fully understand health and illness.

This program announcement invites applications for research on the social and cultural dimensions of health in five areas:

1. Basic social and cultural constructs and processes used in health research.

2. Etiology of health and illness

3. Consequences of poor health for individuals and social groups.

4. Linking science to practice to improve prevention, treatment, health services, and dissemination.

5. Ethical issues in social and cultural research.

The goal of this announcement is to encourage further development of health-related social sciences research relevant to the missions of the ICs. These missions encompass a broad range of scientific questions related to the health and well-being of our nation's people. Information about the specific missions of the ICs participating in this program announcement is posted at http://www.nih.gov/icd/.

1. Basic Constructs and Processes

Advances in social science research on health depend on a foundation of basic theory and knowledge that describes social structures, the dynamics of social and cultural processes, and the ways in which individuals are located in and interact with the environment, social structures, and cultural factors. Several key sociodemographic constructs, including race, ethnicity, gender, age, and socioeconomic status, are widely used in studies of the etiology of health and disease and in research that describes and monitors the distribution of disease across social categories, geographic areas, and time. However, the meanings of such constructs depend on their cultural, geographical, and historical context, and their utility in health research depends on their use in ways that are theoretically and historically grounded. In addition, the concept of culture requires careful theoretical grounding in health studies. Most social scientists agree that the concept of culture is complex and implies a dynamic and ever-changing process.

This program announcement encourages research on basic social and cultural constructs and processes in the following areas:

Social Stratification and Inequalities

Research is needed to explore the implications of different conceptualizations and measurements of social stratification systems and processes, such as socioeconomic status (SES) and social class, age, gender, and race/ethnicity for understanding health at the individual and higher levels of aggregation (e.g., community). Research to improve the monitoring and understanding of inequalities in health and disease among diverse groups, and the implications for monitoring of strategies used to measure basic constructs such as socioeconomic status and social class, age, gender, race, and ethnicity.

The National Research Council‘s study of Critical Perspectives on Racial and Ethnic Differences in Health and Late Life discusses several issues related to racial and ethnic inequalities in health, including the nature of racial and ethnic differences, an outline of causal pathways implicated in health disparities, and a research agenda in the field of racial and ethnic differences in health. (See N. B. Anderson, R. A. Bulatao, and B. Cohen, Editors, Panel on Race, Ethnicity, and Health in Later Life, National Research Council, Critical Perspectives on Racial and Ethnic Differences in Health in Late Life, The National Academies Press, Washington, DC, 2004.)

Social Integration

Research is required to clarify the social, cultural, and economic factors that influence the social integration of individuals and the social cohesion of groups, including the causal dynamics of social networks.

Culture

Studies are necessary to improve the conceptualization and operationalization of culture as well as of social and cultural change in health research. Efforts are needed to identify those definitions and dimensions of cultural phenomena and intra-cultural and inter-cultural variation and change that are most useful in understanding health, and the mechanisms through which cultural phenomena influence health.

2. Etiology

Social science research on the etiology of health and illness recognizes that health may be affected by a diverse set of mechanisms operating among and within social structures existing at different levels. At the highest levels are structures and processes that involve and affect populations broadly: government, media, economic systems, social stratification, political processes and policy-making, and broadly-held cultural values and practices. Some of these processes also operate in communities and neighborhoods, in social institutions (e.g., schools, churches, and businesses), and in social or professional organizations. However, at these levels processes contributing to social cohesion, social support, social control, social and cultural conflict, and the development and enforcement of social and cultural norms play a larger role. In families and small groups, interpersonal processes such as conflict and support, socialization, and sharing of resources play a dominant role.

A valuable contribution of the social sciences is to understand health and disease not solely as an individual biological problem, but as a social phenomenon associated with social ties and other forms of social influences. From this perspective, research must address how mechanisms that link social and cultural phenomena to health operate within and emerge from specific social contexts. Social contexts provide the stage for social and cultural factors to influence health, and the characteristics of social context directly affect social and cultural processes.

This Program announcement encourages research on topics and questions such as the following:

Overarching Issues

Research is needed to improve understanding of how macro-level (societal) factors, such as social policies, structures, and cultural norms, are linked to micro-level (individual) factors, such as a person's behaviors, and ultimately to health. What are the causal pathways that lead from the sociocultural environment to general vulnerability to disease and disease-specific outcomes? Research that integrates theories and methods from the social and biomedical sciences is particularly encouraged to address these questions.

Interpersonal, Social, and Cultural Factors

Essential are studies of the implications for health of the characteristics and content of network ties and of how individuals and groups organize themselves into networks and other social arrangements, including the mechanisms through which social integration/cohesion, social influence, and other social processes affect the health of individuals and contribute to health disparities. More research is needed on cultural processes and belief systems (such as religion or the nature of health/disease), at the individual, family, community, and institutional levels, and their relationships to health, including recovery from disease and addiction, with particular attention to potential mediating mechanisms (e.g., socially-determined patterns of stress and coping with stress).

Social Contexts

Research is considered necessary on the role of social contexts (e.g., family and households, religious institutions, work places, schools, health-care organizations and systems, neighborhoods, and communities, geographic location, residential segregation, legal and administrative policies, communication environments) in mediating or moderating sociocultural influences on health of individuals. Studies are required to conceptualize and measure social contexts in order to specify which particular aspects of social context are relevant to health and the mechanisms through which they operate. This includes research on how health policies impact on diverse populations, such as those defined by immigration status, gender, race/ethnicity, sexual orientation, or age, and on the pathways through which social policies (such as gun control, urban renewal, welfare reform, and taxes on alcohol and tobacco products) affect the health of diverse populations.

3. Consequences of Poor Health

Connections among health, functional capacity, and productivity are complex and difficult to disentangle, but empirical research is emerging that addresses the consequences of poor health for economic well-being at the individual, family, and population levels. Understanding the consequences of health and illness is important to the mission of the NIH. First, health disparities among groups varying in socioeconomic status result in part from the reciprocal influence of SES on health and health on SES. The nature of these feedbacks needs to be fully understood if we are to understand the mechanisms underlying health disparities. Second, the value of investment in improving health can be only partially understood by focusing on health outcomes alone. For example, improvements in quality of life resulting from social, economic, and cultural change at both the individual and societal level are an important part of the picture.

This program announcement encourages research on the consequences of poor health, such as the following:

Self Care

Research is desired on self-care or self-regulation (including the choice of complementary or alternative medical practices) as a response to illness and in the management of health conditions, considering the influence of social, cultural, and economic factors on the adoption and consequences of this strategy.

Coping Strategies

Required are investigations of the coping strategies people use to adapt to illness and disability, the influence of social, cultural, and economic factors on these strategies, and the impact of these strategies on health and well-being at the individual, family, and community level. Research on the consequences of death and dying for the health and well-being of the deceased's relatives and friends as well as on the coping strategies people use to adapt to illness, disability, and death of a relative or close friend.

Social Stigma

Needed are studies of stigma across physical and mental health conditions (including addictions), care settings, outcomes and groups, including research on the social and cultural origins of stigmatization of illnesses. What are the implications of stigma for access to care and treatment? How does stigma affect outcomes across health conditions?

Impact of Health on Society

Research is necessary to examine how the health of individuals impacts upon macro-level processes and systems is also needed. How does the health of individual members of a group (e.g., family, household, firm) affect the composition and functioning of the group? Also of interest is research on the influence of poor health on economic performance of organizations and societies. (For example, see International Studies of Health and Economic Development, NIH Guide to Grants and Contracts, May 30, 2000; http://grants.nih.gov/grants/guide/rfa-files/RFA-TW-01-001.html)

4. Linking Science to Practice to Improve Prevention, Treatment, Health Services, and Dissemination

The social sciences are important in efforts to prevent and treat illness and to promote health. Research in the social sciences can pinpoint environmental contexts, social relationships, interpersonal processes, and cultural factors that lead people to engage in healthy behaviors, seek health services before disease symptoms worsen, and participate with medical professionals in treating illness. The incorporation of social science research and theory into prevention, treatment, service, and health-promotion programs is likely to result in more effective interventions. In addition, research on the dissemination and translation of social science research findings can ensure that investments in basic research have their maximum impact on health.

This program announcement encourages social sciences research on prevention, treatment, health services, health promotion, and information and program dissemination in the following areas:

Prevention

Greater theoretical development and conceptual work is needed in the field of prevention, including clarifying the concepts of risk and protection and their meanings within distinct populations, defining the distinctions between health promotion and disease prevention, and promoting generalizability of theoretical frameworks. Research is desirable to design, implement, and evaluate interventions based upon the theories, concepts, and methods identified earlier in this announcement (e.g., social networks, social contexts, cultural beliefs).

Treatment and Management of Disease

Research is needed on cultural competence at multiple levels, including health systems, agencies and providers, with an emphasis on primary care and mental health settings. Also, research is essential to define what constitutes “culturally competent care”, develop and test different models (best practices) of culturally competent care, and test models in randomized controlled trials. Research is desired that explores the interface between traditional/alternative and allopathic/western medicine and health maintenance practices and identifies the circumstances under which either or both function more effectively.

Services

Research on the development, dissemination, and accessibility of new therapies, technologies and services, such as retrovirals and anti-psychotics. How do social and cultural factors affect these processes and what impact do they have on services and treatment? How do social, cultural, economic, and policy mechanisms influence equitable access to health care and the quality of care received?

Dissemination and Adoption

Research is essential on the processes through which social and behavioral interventions are incorporated into general practice. What accounts for success or failure (i.e., adoption vs. non-adoption)? How does this differ from the adoption of biomedical treatments and interventions? Systematic research is required on methods to increase the adoption of tested and effective preventive interventions, treatment models, and service delivery strategies. Also increased research is needed that will allow rigorous comparisons of the effects of alternative methods of diffusion and dissemination.

5. Ethical Issues in Social and Cultural Research

The development of new and more complex research methods in the social sciences, combined with dramatic advances in computing power, complicates standard ethical concerns of confidentiality, privacy, and consent. Higher levels of analysis imply analysis of data at the group, institution, or community level, raising the prospects of consent at these levels and how such consent might be obtained. Sensitivity exists not only at the individual level but also for the groups and institutions with which individuals affiliate.

This program announcement encourages social sciences research on ethical issues in the following areas:

Ethical issues arising from research that links the individual to groups, organizations, neighborhoods or communities.

Threats to confidentiality of data collected in multi-level studies by advancing statistical methods for masking or altering individual data and studying how such procedures impinge on the ability to conduct valid analyses.

Unintended consequences of research aimed at understanding variation among individuals and among groups. How to avoid overemphasizing individual and group differences and thereby reinforcing existing patterns of stratification in health care or other areas.

Community consultation in research projects involving identified population groups. How can individual informed consent best be accomplished in this setting?

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

Section II. Award Information


1. Mechanism of Support

This Funding Opportunity Announcement (FOA) will use the Research Project Grant (R01) award mechanism.   

The applicant will be solely responsible for planning, directing, and executing the proposed project.  

This FOA uses “Just-in-Time” information concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm).

Specifically, if you are a U.S. organization and 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). 

U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096   

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 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.

NIH grants policies as described in the NOT-OD-05-004, November 2, 2004.  

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

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, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach that clearly does not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

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

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Applications can be renewed by competing for additional project periods.

Applicants may submit more than one application, provided each application is scientifically distinct. 

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, link to http://www.grants.gov/applicants/apply_for_grants.jsp and follow the directions provided on that Web site.

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

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

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

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

2) Organizational/Institutional Registration in the eRA Commons

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

Both the PD/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

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 in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the 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 301-435-0714, Email: GrantsInfo@nih.gov.

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 and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

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 has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in 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., “Special Instructions,” regarding appropriate required budget component.)
Research & Related Budget (required for foreign applications)
 
Optional Components:

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

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

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600260.

Applications from foreign organizations must:

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

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 in item 15 of 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.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled “Multiple PD/PI Leadership Plan” (section 14 of the Research Plan Component in the SF424 (R&R) or Section I of the Research Plan in the PHS 398), must be included. A rationale for choosing a multiple PD/PI approach should be described.  The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators. 

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

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 note 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

Applications must be mailed on or before the receipt date described at http://grants.nih.gov/grants/funding/submissionschedule.htm. Submission times N/A.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: January 5, 2007  (Earliest date an application may be submitted to Grants.gov).
Letters of Intent Receipt Date(s): Not applicable.
Application Submission/Receipt Date(s):  Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission/Receipt Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward  

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

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/applicants/apply_for_grants.jsp and follow steps 1-4. Note:  Applications must only be submitted electronically.  PAPER APPLICATIONS WILL NOT BE ACCEPTED. 

3.C. Application Processing

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 submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any 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 business days to view the application image.

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 receives the Grants.gov acknowledgments. The AOR 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 their 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. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an “Introduction” (3 pages maximum) addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).

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 or competing renewal (formerly “competing continuation”) 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 or competing renewal 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

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

The NIH requires the PD/PI(s) 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.

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

Items 2-5 of the PHS398 Research Plan component are limited to 25-pages. While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. 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.

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 additional requirements:

Special Instructions for Modular Grant applications

R01 applications from U.S. institutions/organizations requesting up to $250,000 per year in direct costs (excluding consortium F&A costs) must be submitted in a modular budget format. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm. When submitting a modular budget, the applicant organization will include only the PHS398 Modular Budget component. See Section 5.4 of the SF424 (R&R) Application Guide for further instructions regarding the use of the PHS398 Modular Budget component.

Foreign organizations may not submit modular budgets. See NOT-OD-06-096

Special Instructions for Applications Requesting $500,000 (direct costs) or More Per Year

Applicants requesting $500,000 or more in direct costs for any year (excluding consortium F&A costs) must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study;

2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and,

3) Include the PHS398 Cover Letter component with the application to identify the staff member and IC who agreed to accept assignment of the application.

This policy applies to all new applications, competing renewal (formerly “competing continuation”) applications, resubmission (formerly “revised/amended”) applications, and revision (formerly “competing supplemental”) applications. See NOT-OD-02-004, October 16, 2001. 

 APPENDIX MATERIALS

Stop SignIMPORTANT NOTE: NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review.

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).

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Note: While each section of the PHS398 Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to monitor better formatting requirements such as page limits. 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.  

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

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal Web site, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy expects that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement  http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., “Reporting.”

Section V. Application Review Information


1. Criteria
 
Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

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

Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.

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

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

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? 

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?  For applications designating multiple PIs, does the Leadership Plan ensure that there will be sufficient coordination and communication among the PD/PIs?  Are the administrative plans for the management of the research project appropriate, including plans for resolving conflicts?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches or methodologies, tools, or technologies for this area?

Investigators: Are the PD/PIs and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level(s) of the principal investigator(s) and other researchers? Do the PD/PIs and investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment(s), or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? 

2.A. Additional Review Criteria

In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See the “Human Subjects Sections” of the PHS398 Research Plan component of the SF424 (R&R).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See the “Human Subjects Sections” of the PHS398 Research Plan component of the SF424 (R&R).
 
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, t
he adequacy of the plans for their care and use will be assessed. See the “Other Research Plan Sections” of the PHS398 Research Plan component of the SF424 (R&R).  

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. The priority score should not be affected by the evaluation of the budget.

Applications from Foreign Organizations: Does the project present special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed.

Resubmission Applications (formerly “revised/amended” applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing.

2.D. Sharing Research Resources

NIH policy expects that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement  http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590), See Section VI.3., “Reporting.”
 
3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information


1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts


GENERAL INQUIRIES regarding the scope and content of this program announcement should be directed to:

Ronald P. Abeles, Ph.D.
Special Assistant to the Director
Office of Behavioral and Social Sciences Research
National Institutes of Health
Gateway Building, Room 2C234, MSC 9205
7201 Wisconsin Avenue
Bethesda, MD 20892-9205
Telephone: 301-496-7859
Fax: 301-435-8779
E-mail: abeles@nih.gov

Direct inquiries regarding PROGRAMMATIC ISSUES, including questions of research areas of particular interest to and of possible funding mechanisms in addition to R01s at each IC, to the staff of the appropriate IC:

Catherine Stoney, Ph.D.
National Center for Complementary and Alternative Medicine
6701 Democracy Blvd., Suite 401
Bethesda, MD 20892-5475
Telephone: 301-402-1272
Fax: 301-480-3621
E-mail: stoneyc@mail.nih.gov

Julaine M. King, M.P.H.
Research Program Analyst
Rheumatic Diseases Branch
Extramural Program
National Institute of Arthritis and Musculoskeletal and Skin Diseases
6701 Democracy Boulevard, Suite 800
Bethesda, Maryland 20892
Telephone: 301-594-5592
Fax: 301-480-1284
E-mail: kingju@mail.nih.gov

Ruth Nowjack.Raymer, MPH, Ph.D.
Center for Clinical Research
National Institute of Dental and Craniofacial Research
Building 45, Room 4AS.43D
45 Center Drive MSC 6401
Bethesda, Maryland 20892
Telephone: 301.594.5394
Fax: 301.480.8322
E-mail: Ruth.Nowjack-Raymer@nih.gov

Christine A. Bachrach, Ph.D.
Center for Population Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, Rm. 8B07, MSC 7510
Bethesda, MD 20892-7510
Telephone: 301-496-1174
Fax: 301-496-0962
E-mail: Cbachrach@nih.gov

Jared B. Jobe, Ph.D.
National Heart, Lung, and Blood Institute
6702 Rockledge Drive, Room 8120
Bethesda, MD 20892
Telephone: 301-435-0407
Fax: 301- 480-1773
E-mail: JobeJ@nhlbi.nih.gov

Sabra Woolley, Ph.D.
Division of Cancer Control and Population Sciences
National Cancer Institute
EPN 4078
6130 Executive Boulevard
Rockville, MD 20852
Telephone: 301-435-4589
Fax: 301-480-2087
E-mail: woolleys@mail.nih.gov

Vivian Ota Wang, Ph.D.
National Human Genome Research Institute
Division of Extramural Research
5635 Fishers Lane, Suite 4076 MSC 9305
Bethesda, MD 20892-9305
Telephone: 301-496-7531
Fax: 301-480-2770
E-mail: otawangv@mail.nih.gov

Marcia S. Scott, Ph.D.
Division of Epidemiology and Prevention Research
National Institute of Alcohol Abuse and Alcoholism
DHHS/National Institutes of Health
5635 Fishers Lane, Suite 2085
Rockville, MD 20892-9304
Telephone: 301-402-6328
Fax: 301-443-8614
E-mail: mscott@mail.nih.gov

Yonette F. Thomas, Ph.D.
Chief, Epidemiology Research Branch
Division of Epidemiology, Prevention, and Services Research
National Institute on Drug Abuse/National Institutes of Health
6001 Executive Boulevard, Rm 5169, MSC 9589
Bethesda, MD 20892-2589
Telephone: 301-402-1910
Fax: 301-480-2543
E-mail: ythomas@mail.nih.gov

Sanford A. Garfield, Ph.D.
Division of Endocrinology and Metabolic Diseases
National Institute on Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 685
Bethesda, MD 20892-5452
Telephone: 301-594-8803
E-mail: garfields@extra.niddk.nih.gov

Emeline Otey, Ph.D.
Division of AIDS and Health Behavior Research
National Institute of Mental Health
National Institutes of Health
6001 Executive Blvd, Room 6227
Bethesda, MD 20892-9615
Telephone: 301-443-9284
Fax: 301-480-2920
E-mail: eotey@mail.nih.gov

Martha L. Hare, Ph.D., R.N
NIH/National Institute of Nursing Research
6701 Democracy Boulevard
One Democracy Plaza, Room 710
Bethesda, MD 20892-4870
Telephone: 301-451-3874
Fax: 301-480-8260
E-mail: Martha.hare@nih.gov

Sidney Stahl, Ph.D.
Behavioral and Social Research Program
National Institute on Aging
Gateway Building, Room 525 MSC 9205
7201 Wisconsin Avenue
Bethesda, MD 20892-9205
Telephone: 301-402-4156
Fax: 301-402-0051
E-mail: stahls@mail.nih.gov

Kimberly Gray, Ph.D.
Chemical Exposures and Molecular Biology Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-3445
111 T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: 919-541-0293
Fax: 919316-4606
E-mail: gray6@mail.nih.gov

Lana Shekim, Ph.D.
Director, Voice & Speech Programs
Division of Scientific Programs
National Institute on Deafness and Other Communication Disorders
6120 Executive Blvd., EPS Room 400C MSC 7180
Bethesda, MD 20892
Telephone: 301-496-5061
Fax: 301-402-6251
E-mail: shekiml@nidcd.nih.gov

2. Peer Review Contacts:

Not applicable.

3. Financial or Grants Management Contacts:

Ms. Judy Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3023, MSC 9304
Bethesda, MD 20892-9304
FOR EXPRESS MAIL: Rockville, MD 20852-1705
Telephone: 301-443-4704
Fax: 301-443-3891
E-mail: jfox@mail.nih.gov

Mr. Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD 20892-9541
Telephone: 301-443-6710
Fax: 301-594-6849
E-mail: gfleming@nida.nih.gov

Ms. Cecilia E. Bruce
Supervisory Grants Management Specialist (Team Leader)
National Institute of Child Health and Human Development
6100 Executive Blvd - Room 8A17L
Rockville, Maryland 20852
Telephone: 301-496-1304
Fax: 301-480-4782
E-mail: brucec@mail.nih.gov

Ms. Melinda B. Nelson
Chief Grants Management Officer
National Institute of Arthritis and Musculoskeletal and Skin Diseases
45 Center Drive, Room 5AS49
Bethesda, MD 20892
Telephone: 301-435-5278
Fax: 301-480-4543
E-mail: nelsonm@mail.nih.gov

Ms. Mary E. Daley
Office of Grants Management
National Institute of Dental and Craniofacial Research
45 Center Dr MSC 6402
Bethesda, MD 20892-6402
Phone: 301-594-4800
Fax: 301-480-8303
E-mail: md74u@nih.gov

Mr. David L. Mineo
Chief Grants Management Officer
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Two Democracy Plaza, Room 731
6707 Democracy Blvd., MSC 5456
Bethesda, Md. 20892-5456
Telephone: 301-594-885
E-mail: mineod@extra.niddk.nih.gov

Ms. Rebecca Claycamp, CRA
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard
Room 6122, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2811
E-mail: rclaycamp@mail.nih.gov

Ms. Teresa Farris Marquette
Section Chief
Office of Grants Management
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Suite 700
Bethesda, Maryland 20892-7936
Telephone: 301-435-0171
Fax: 301-435-3310
Email: tm275a@nih.gov

Ms. Kelli Oster
Grants Management Specialist
Office of Grants and Contracts Management
National Institute of Nursing Research, NIH
6701 Democracy Blvd, Room 710
One Democracy Plaza
Bethesda, MD 20892-4870 (courier use 20817)
Telephone: 301-594-2177
Fax: 301-402-4502
E-mail: osterk@mail.nih.gov

Ms. Cheryl Chick
Scientific Review Branch/Grants Administration Branch
National Human Genome Research Institute, NIH
5632 Fishers Lane, Suite 4076, MSC 9306
Bethesda, MD 20892-9306
TEL: 301-435-7858
Fax: 301-402-1951
E-mail: ChickC@mail.nih.gov

Mr. George Tucker
Grants Management Branch
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892-5475
Telephone: 301-594-9102
E-mail: george.tucker@nih.hhs.gov

Ms. Crystal Wolfrey
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
6120 Executive Boulevard, MSC 7150
Bethesda, MD 20892-7150
Telephone: 301-496-8634
Fax: 301-496-8601
E-mail: wolfreyc@mail.nih.gov

Mr. Richard Proper
Grants and Contracts Management Office
National Institute on Aging
Gateway Building, Room 2N212, MSC 2292
7201 Wisconsin Avenue
Bethesda, MD 20892-2292
Telephone: 301-496-1472
Fax: 301-402-3672
E-mail: properr@mail.nih.gov

Ms. Carolyn Winters
Grants Management Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-24
111 T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: 919-541-7823
Fax: 919-541-2860
E-mail: winters@niehs.nih.gov

Mr. Christopher Myers
Chief Grants Management Officer
National Institute on Deafness and Other Communication Disorders
6120 Executive Blvd., EPS Room 400B MSC 7180
Bethesda, MD 20892-7180
Telephone: 301-402-0909
Fax: 301-402-1758
Email: myersc@mail.nih.gov

Ms. Melinda Nelson
Grants Management Officer
National Institute on Arthritis, Musculoskeletal, and Skin Diseases
6701 Democracy Blvd., Suite 800
Bethesda. MD 20892
Telephone: 301-594-3535
Fax: 301-480-5450
Email: nelsonm@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

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

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

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

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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

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

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

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

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

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov// and view the Policy or other Resources and Tools, including the Authors' Manual.

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

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

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

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

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

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

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


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