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 Research on Women’s Health (ORWH) http://orwh.od.nih.gov
National Cancer Institute (NCI) www.cancer.gov
National Human Genome Research Institute (NHGRI) http://www.genome.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 of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) http://www.niams.nih.gov/
National Institute of Biomedical Imaging and Bioengineering (NIBIB) http://www.nibib1.nih.gov/
National Institute of Child Health and Human Development (NICHD) http://www.nichd.nih.gov/
National Institute of Dental and Craniofacial Research (NIDCR) http://www.nidcr.nih.gov/
National Institute on Drug Abuse (NIDA) http://www.nida.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 Neurological Disorders and Stroke (NINDS) http://www.ninds.nih.gov/
National Library of Medicine (NLM) http://www.nlm.nih.gov/
Fogarty International Center (FIC) http://www.fic.nih.gov/
National Center for Complementary and Alternative Medicine (NCCAM) http://www.nccam.nih.gov/
Office of Dietary Supplements (ODS) http://ods.od.nih.gov
Office of Behavioral and Social Science Research (OBSSR) http://obssr.od.nih.gov/

Title: Advancing Novel Science in Women’s Health Research (ANSWHR)(R03)

Announcement Type
New

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: PAS-07-382

Catalog of Federal Domestic Assistance Number(s)
93.393 93.394 93.395 93.396 93.399 93.172 93.866 93.273 93.846 93.286  93.865 93.121 93.279 93.113 93.242 93.853 93.361 93.879 93.989 93.213

Key Dates
Release/Posted Date: June 11, 2007
Opening Date: August 16, 2007 (Earliest date an application may be submitted to Grants.gov)

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):  October 16, 2007; October 16, 2008; October 16, 2009; for new applications November 16, 2007; November 16 2008; November 16, 2009 for resubmission applications
AIDS Application Submission/Receipt Dates:  January 7, 2008; January 7, 2009; January 7, 2010
Peer Review Date(s): February/March 2008; February/March 2009; February/March 2010
Council Review Date(s): May 2008; May 2009; May 2010.
Earliest Anticipated Start Date(s):
July 1, 2008; July 1, 2009; July 1, 2010.
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: January 8, 2010

Due Dates for E.O. 12372

Not Applicable.

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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


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


Section IV. Application and Submission Information
1. Request Application Information

2. Content and Form of Application Submission
3. Submission Dates and Times
    A. 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 Contact(s)

1. Scientific/Research Contact(s)
2. Peer Review Contact(s)

3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Purpose

The Office of Research on Women’s Health (ORWH), established in 1990 within the Office of the Director, NIH, (a) advises the NIH Director and staff on matters relating to research on women’s health; (b) strengthens and enhances research related to diseases, disorders, and conditions that affect women; (c) ensures that research conducted and supported by NIH adequately addresses issues regarding women’s health; (d) ensures that women are appropriately represented in biomedical and biobehavioral research studies supported by NIH; (e) develops opportunities for and supports recruitment, retention, reentry, and advancement of women in biomedical careers; and (f) supports research on women’s health issues. ORWH works in partnership with the NIH institutes and centers to ensure that women’s health research is part of the scientific framework at NIH and throughout the scientific community.

The ORWH announces the publication of an investigator-initiated small grants program, using the R03 grant mechanism.  This trans-NIH research program funding opportunity is called ANSWHR, Advancing Novel Science in Women’s Health Research. Using the R03 grant mechanism, ORWH will fund meritorious women’s health research and sex/gender research in scientific partnership with the NIH institutes and centers.

The overall purpose of ANSWHR is to stimulate and support innovative research that will advance new concepts in women’s health research and the study of sex/gender differences.  ORWH and its scientific partners across the NIH are interested particularly in encouraging extramural investigators to undertake new interdisciplinary research to advance studies on how sex and gender factors affect women's health. 

During the past several years, research reports clearly established the importance of studying issues specific to women and female-male differences in all areas of science from basic science studies of molecular genetics to studies of epidemiology, etiology, and prevention/treatment interventions. The scientific and clinical importance of analyzing data separately for females and males is becoming more and more evident.

The common characteristic of the small grant is provision of limited funding for a short period of time. Examples of the types of projects that ORWH and its IC scientific partners support with the R03 include the following:

Because ORWH is an office within the Office of the NIH Director and does not have “grant-making authority”, the partnership between ORWH and the NIH institutes and centers will be operationalized as follows:

Applications submitted to this PAS will be directed to the most appropriate NIH institute or center (called primary IC), based on scientific focus, by CSR. 

Applications will then undergo standard NIH scientific review, using established IRG groups. After scientific review and institute/center council review/approval, ORWH will provide funding for those grants selected for award. All pre-award requirements and the grant award notice will be handled by the primary IC.  Scientific and grants management oversight will reside in the primary NIH institute or center for the duration of funding, with ORWH remaining actively involved in this PAS. 

Scientific Scope of the ANSWHR Program

The scientific basis for the ANSWHR program derives from three main sources:

(A). The NIH Research Priorities for Women’s Health which are reviewed and published annually on the ORWH website, http://orwh.od.nih.gov/research/priorities.html.

(B). The report, Agenda for Research on Women's Health for the 21st Century, which was developed in collaboration with the NIH and the extramural scientific and public advocacy communities; and

(C). The Institute of Medicine Report, "Exploring the Biological Contributions to Human Health, Does Sex Matter?" Detailed discussion of these sources follows.

A.  FY 2007 NIH Research Priorities for Women’s Health

Each year, the ad hoc Research Subcommittee of the Coordinating Committee on Research on Women’s Health (CCRWH), composed of representatives from the NIH institutes and centers, considers continuing gaps in knowledge, and emerging scientific opportunities for current research priorities in women’s health. The Subcommittee’s recommendations are reviewed and approved by the CCRWH and the Advisory Committee on Research on Women's Health (ACRWH), and posted on the ORWH website, at http://orwh.od.nih.gov/research/priorities.html.

The FY 2007 NIH Research Priorities for Women’s Health are described in terms of overarching themes, areas of research interest, and special emphasis areas.  The priorities signify approaches and areas for which there is a need to stimulate and encourage research on women’s health, or sex/gender factors, and the advancement of women in biomedical research careers.  These research priorities are not an exclusive list of research areas important to women’s health, therefore other innovative or significant research areas also should be considered.

Overarching Themes

The following four overarching themes are important for addressing research on women’s health: Lifespan, Sex/Gender Determinants, Health Disparities/Differences and Diversity, and Interdisciplinary Research.

Lifespan: The health of girls and women is affected by developmental, physiological, and psychological age.  Women’s lives are marked by a continuum from intrauterine life to the elderly years: infancy, childhood and adolescence, menarche, reproductive life, the menopausal transition, postmenopausal years, the elderly, and the frail elderly.  The lives and health status of women are influenced by many factors such as work inside and outside the home, care-giving, especially to children and elder care responsibilities, reproductive status, marital status, and chronic illness.  Each of these factors may influence health, disease, lifestyle, treatment choices, and response to therapy.  Researchers should consider these variables in designing studies related to women’s health.

Sex/Gender Determinants: Women are characterized by both sex and gender as highlighted in the Agenda for Research in Women’s Health for the 21st Century and the Institute of Medicine report, entitled Exploring the Biological Contributions to Human Health: Does Sex Matter?  In this context, the term sex refers to identification as male or female according to reproductive organs and functions assigned by chromosomal complement.  Sex factors that contribute to the biological differences include chromosomes, reproduction, and hormones.  Gender refers to socially defined and derived expectations and roles rooted in biology and shaped by environment and experience.  Gender and sex are important considerations in most areas of research, including basic biological, psychological, social, and behavioral studies.  Consideration of these variables is critical to the accurate interpretation and validation of research affecting women’s health.  These variables determine how health or disease processes may differ among women or between men and women.

Health Disparities/Differences and Diversity: Women are disproportionately affected by some conditions and diseases in terms of incidence, diagnosis, course, and response to treatment.  Some populations of women may be at higher risk for adverse disease outcomes because of factors such as: biology, genes, culture, education, effects of poverty, access to care, quality of care, and access to opportunities for inclusion as research subjects in clinical trials and studies.  Thus, clinical research should include, but not be limited to, population-specific characteristics such as cultural diversity, race/ethnicity, immigrant status, rural or inner city residency status, effects of poverty or low socioeconomic status, sexual orientation, and physical or mental disabilities.

Interdisciplinary Research: With increasing understanding of the inter-relatedness and complexity of disease, the nature of scientific investigation is shifting to an interdisciplinary collaborative approach.  Advances in women’s health can be better achieved by promoting partnerships across disciplines.  Interdisciplinary approaches can integrate knowledge from multiple specialties and disciplines, thus enhancing the likelihood of defining underlying pathologic processes.  Collaborations among researchers in academia, private industry, and federal settings can provide access to the latest scientific tools and technologies and expertise for women’s health research.

Areas for Women’s Health Research    

Basic, clinical and translational research should be considered in addressing priority areas in women’s health research. Some examples may include, but are not limited to:

Special Emphasis Areas

The NIH is interested especially in fostering research in women’s health in the high priority areas of prevention and treatment, and the biological and behavioral basis of sex and gender differences.

Prevention, Treatment and Treatment Outcomes. Increased investigation into methods to prevent conditions and diseases, or to optimize treatment, can result in significant improvements in the quality and length of women’s lives.  Prevention research spans the continuum from the most basic biological studies to understanding the bases and effects of risk behaviors across the lifespan and the interventions to change them, including a focus on wellness and healthy behaviors.  Examples of needed prevention and treatment research studies in women’s health include, but are not limited to:

Biological and Behavioral Basis of Sex and Gender Differences. Whereas there has been much research to identify the function of cellular pathways and genes, research on the effects of sex as a modifier of cellular and gene function is under-investigated.  Systemic and cellular modeling of the influence of sex differences in biological pathways and systems is needed, including, but not limited to:

B. an Agenda for Research on Women’s Health for the 21st Century

The ORWH has published "An Agenda for Research on Women's Health for the 21st Century", A Report of the Task Force on the NIH Women’s Health Research Agenda for the 21st Century, based on a series of four scientific workshops.  This outline represents the recommendations from these national meetings examining research needs for women's health: (1) Scientific Areas, (2) Sex and Gender Perspectives throughout the Life Cycle; and (3) Differences among Populations of Women throughout the Life Cycle.  The executive summary of these outcomes is available at the following URL:  http://orwh.od.nih.gov/research/resagenda.html.

C. The Institute of Medicine Report, "Exploring the Biological Contributions to Human Health, Does Sex Matter?" 

This report, published in 2001, includes three overarching conclusions. (1) Sex matters. Sex, that is, being female or male, is an important basic human variable that should be considered when designing and analyzing studies in al areas and at all levels of biomedical and health-related research. (2) The study of sex differences is evolving into a mature science. There is now sufficient knowledge of the biological basis of sex differences to validate the scientific study of sex differences, and to allow the generation of hypotheses. (3) Barriers to the advancement of knowledge about sex differences in health and illness exist and must be eliminated. The report states that the question of sex needs to be routinely asked in research studies, and the results, positive or negative, need to be routinely reported in order to advance our understanding of the pathogenesis of disease.

This report also discusses the terms ‘sex’ and ‘gender’, and how they are sometimes used interchangeably in research literature.  The report defines sex as “the classification of living things, generally as male or female according to their reproductive organs and functions assigned by their chromosomal complement, and gender as a person’s self-representation as male or female, or how that person is responded to by social institutions on the basis of the individual’s gender presentation.  Gender is shaped by environment and experience.”  Thus, sex is a biological construct whereas gender is a psychosocial construct.  This distinction notwithstanding, epigenetic research reveals that biological factors often unfold in ways that are influenced by the environment and thus can obviate this distinction between sex and gender. 

Therefore, because it is often not known a priori whether a female-male difference is sex-based, gender-based or both, in this program announcement ‘sex/gender difference’ will be used generically to refer to female-male differences regardless the origins of the differences, although a search for those origins is a major focus of this announcement.

In non-human animal research, however, the term ‘sex difference’ is the preferred term.  Additionally, researchers are encouraged to recognize that a sex/gender difference is sometimes only a proxy for an unidentified independent variable(s).  Thus, finding a sex/gender difference typically should be regarded as a first step in a search for such variables as their identification will shed light on the phenomenon under study.   For review of the entire report, please see http://www.nap.edu and http://www.iom.edu/CMS/3740/5437.aspx. (http://lab.nap.edu/openbook/0309072816/html/1.html

In addition to the three main resources presented above, other examples of areas of interest are offered as a guide to interested investigators.

 Sex and Gender Differences 

Cross-cutting Issues

Institute/Center-Specific Research Interests and Requests

In addition to the research guidelines stated above, the following NIH institutes and centers state the following:

Secondary Data Analyses

Under this PAS, investigators may request funds to perform secondary data analyses of either their own data sets or other data sets that are publicly available.

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

Section II. Award Information


1. Mechanism(s) of Support

This Funding Opportunity Announcement (FOA) will use the NIH Small Research Grant (R03) 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 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 found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006. 

Competing renewal (formerly “competing continuation”) applications will not be accepted for the R03 grant mechanism. Small grant support may not be used for thesis or dissertation research. Up to two resubmissions (formerly “revisions/amendments") of a previously reviewed small grant application may be submitted. See NOT-OD-05-046, April 29, 2005.  

For specific information about the R03 programs, see: http://grants.nih.gov/grants/funding/r03.htm

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

A project period of up to two years and a budget for direct costs of up to two $25,000 modules, or $50,000 per year, may be requested (i.e., a maximum of $100,000 over two years in four modules of $25,000 each). Commensurate Facilities and Administrative (F&A) costs are allowed.

F&A costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November 2, 2004.

All awards are subject to the availability of funds. The estimated amount of funds available for support of projects awarded as a result of this announcement is $1 to 1.5 million dollars for fiscal year 2008.  Future year amounts will depend on annual appropriations.

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 with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH 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
 
Foreign Entities. Research applications involving non-US or cross-national data or settings, whether submitted by US-or non-US organizations must inform the causes of or the potential gain for women’s health research in the US. Responsive applications must justify conducting such foreign data collections or their analysis based on their applicability to identified women’s health issues in the US.

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/Apply/ 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 Started

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 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 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 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.

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 Modular Budget
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

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)), 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 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: July 17, 2007 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not applicable.
Application Submission/Receipt Date(s):October 16, 2007; October 16, 2008, October 16, 2009 for new applications
November 16, 2007; November 16 2008; November 16, 2009 for resubmission applications
AIDS Application Submission/Receipt Dates:  January 7, 2008; January 7, 2009; January 7, 2010
Peer Review Date(s): February/March 2008; February/March 2009; February/March 2010
Council Review Date(s): May 2008; May 2009; May 2010
Earliest Anticipated Start Date(s):  July 1, 2008; July 1, 2009; July 1, 2010
Additional Information To Be Available Date (URL Activation Date): Not Applicable

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/Apply and follow steps 1-4. Note:  Applications must only be submitted electronicallyPAPER 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. 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” addressing the previous critique. Note that 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 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

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.”

Renewal (formerly “competing continuation” or “Type 2”) applications are not permitted.  

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, with the following requirements for R03 applications:

Appendix Materials

NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.

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.

Warning: Please be sure that you observe the direct cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.

Note: 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.    

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

Plan for Sharing Research Data

N/A

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 (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

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 Public Health Service (PHS) referral guidelines.

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

Applications that are complete will be evaluated for scientific and technical merit by an appropriate review group convened by CSR, in accordance with the review criteria stated below.
 
As part of the initial merit review, all applications will:

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

The NIH R03 small grant is a mechanism for supporting discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding.  Because the Research Plan component is restricted to 10 pages, a small grant application will not have the same level of detail or extensive discussion found in an R01 application. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem, placing less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.

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 comments, 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. The scientific review group will address and consider each of these criteria in assigning the application's 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?

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

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

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?   
 
2.A. Additional Review Criteria

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

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?

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 item 6 of the 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 item 7 of the Research Plan component of the SF424 (R&R).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under item 11 of the Research Plan component of the SF424 (R&R) will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

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

Applications from Foreign Organizations: Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed.  Does the use of non-US data or settings inform efforts to understand Women’s Health Research in US populations? Are the analyses relevant to identified Women’s Health issues in the US?

2.C. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement  http://grants.nih.gov/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.”
 
Model Organism Sharing Plan:  Reviewers are asked to assess the sharing plan in an administrative note. The sharing plan itself should be discussed after the application is scored. Whether a sharing plan is reasonable can be determined by the reviewers on a case-by-case basis, taking into consideration the organism, the timeline, the applicant's decision to distribute the resource or deposit it in a repository, and other relevant considerations. For the R03 mechanism, the presence or adequacy of a plan should not enter into the scoring of the application.

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.

Section VII. Agency Contacts


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

1. Scientific/Research Contacts:

From the Office of Research on Women’s Health:

Lisa Begg, Dr.P.H., R.N.
Office of Research on Women’s Health
Office of the NIH Director
6707 Democracy Blvd., Suite 400
MSC 5484
Bethesda, MD 20892-5484
Telephone: (301) 496-7853
Email:  beggl@od.nih.gov

National Cancer Institute (NCI) www.cancer.gov

Anna Levy, M.S.
Director
Office of Women’s Health
Office of Science Planning and Assessments
National Cancer Institute
6116 Executive Blvd, MSC 8320
Bethesda, MD 20892-8320 (For overnight mail only, please use Bethesda, MD. 20817) 
Phone:  (301) 301 435 3860
E-mail:  levya@mail.nih.gov

National Human Genome Research Insitute (NHGRI) www.genome.gov

Jean McEwen, J.D.; Ph.D.
Division of Extramural Programs
Room 4076
5635 Fishers Lane
Rockville, MD 20852
Tel: 301-496-7531
E
-mail: jean.mcewen@nih.dhhs.gov

National Institute on Aging (NIA) www.nia.nih.gov

Sherry Sherman, Ph.D.
Geriatrics and Clinical Gerontology Program
National Institute on Aging
Gateway Building, 3C307
7201 Wisconsin Avenue
Bethesda, MD 20810
Tel: 301 435 3048
Email: shermans@nia.nih.gov

National Institute on Alcohol Abuse and Alcoholism (NIAAA) www.niaa.nih.gov

Svetlana Radaeva, Ph.D.
Division of Metabolism and Health Effects
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health/HHS
5635 Fishers Lane
Rockville, MD 20852
Tel: 301 443 1189
Email: sradaeva@mail.nih.gov

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) www.niams.nih.gov

Madeline K. Turkeltaub, PhD, RN
Deputy Director, Extramural Program
National Institute of Arthritis and Musculoskeletal and Skin Diseases
One Democracy Plaza, 892
6701 Democracy Boulevard
Bethesda, MD 20892
Tel : 301 594 2463
Email : turkeltaubm@mai.nih.gov

National Institute of Biomedical Imaging and Bioengineering (NIBIB) www.nibib.nih.gov

Valery Gordon, Ph.D., M.P.H.
Two Democracy Plaza
6707 Democracy Boulevard, Suite 900
Bethesda, MD, 20892
Tel : (301) 451-0161
Fax : 301-480-4973
E-mail: gordonv@mail.nih.gov

National Institute of Child Health and Human Development (NICHD) www.nichd.nih.gov

Estella C Parrott, M.D., M.P.H.
Program Director, Reproductive Medicine Gynecology Program
National Institute of Child Health and Human Development
Exec Building, 8B01
6100 Exec Boulevard
Rockville, MD
Tel : 301-435-6971
E-mail:
parrotte@mail.nih.gov

National Institute of Dental and Craniofacial Research (NICDR) www.nicdr.nih.gov

Maria Teresa Canto, D.D.S., M.S,. M.PH.
Director, Health Promotion and Community Based Research Program
Center for Clinical Research
National Institute of Dental and Craniofacial Research 
Building 45, Room 4AS43D
45 Center Drive
Bethesda, MD 20892
Phone: 301-594-5497
Fax: 301- 480-8322
E-mail: maria.canto@nih.gov

National Institute on Drug Abuse (NIDA) www.nida.nih.gov

Cora Lee Wetherington, PhD
Women's Health Coordinator and Health Scientist Administrator
Behavioral and Cognitive Science Research Branch
National Institute on Drug Abuse
Neuro Science Center, 4245
6001 Executive Boulevard
Rockville, MD
Tel: 301 435 1319
Email: cwetheri@nida.nih.gov

National Institute of Environmental Health Sciences (NIEHS) www.niehs.nih.gov

Jerrold J. Heindel, Ph.D.
Division of Extramural Research and Training
Cellular, Organ & Systems Pathobiology
National Institute of Environmental Health Sciences
4401 Building (East Campus), 3413
79 TW Alexander Drive
Research Triangle Park , NC 27709
Tel: 919 541 0781
Email: heindelj@niehs.nih.gov

National Institute of Mental Health (NIMH) www.mentalhealth.gov

Catherine Roca, M.D.
Director, Office of Women's Mental Health
Office for Special Populations
National Institute of Mental Health
6001 Executive Boulevard, Room 8130
Rockville MD 20852
Tel: 301 443 2847
Email: Croca@mail.nih.gov

National Institute of Neurological Disorders and Stroke (NINDS) www.ninds.nih.gov

Linda Porter, Ph.D.
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard
Bethesda, MD 20892-5484
Tel:  (301) 496-9964
Fax:  (301) 480-2424
E-mail:  porterl@ninds.nih.gov

National Library of Medicine (NLM) www.nlm.nih.gov

Valerie Florance, Ph.D.
Deputy Director, NLM Extramural Programs
National Library of Medicine
Rockledge One
6705 Rockledge Drive, Suite 301
Bethesda, MD 20892
Tel: 301 594 4882
Email: florancev@mail.nih.gov

Fogarty International Center (FIC) www.fic.nih.gov

Aron Primack, MD
Division of International Training and Research
Fogarty International Center
31 Center Drive, Building 31
Room B2C39, MSC 2220
Bethesda, MD 20892
Tel : 301 496 4596
Email : primacka@mail.nih.gov

National Center for Complementary and Alternative Medicine (NCCAM) www.nccam.nih.gov

Catherine Stoney, Ph.D.
Divsion of Extramural Research and Training
National Center for Complementary and Alternative Medicine
6707 Democracy Boulevard, Suite 401
Bethesda, MD 20892
Tel : 301 402 1272
Email : stoneyc@mail.nih.gov

Office of Behavioral and Social Sciences Research (OD/OBSSR) obssr.od.nih.gov

Patricia Mabry, Ph.D.
Office of Behavioral and Social Sciences Research
Office of the Director
National Institutes of Health
31 Center Drive, Building 31,Room B1C19
Bethesda, MD 20892
Tel: 301.402.1146
Email: mabryp@mail.nih.gov

Office of Dietary Supplements (OD/ODS) ods.od.nih.gov

Mary Frances Picciano, Ph.D
Senior Nutrition Specialist
Office of Dietary Supplements
Office of the Director
6100 Executive Blvd., Room 3B01, MSC 7517
Bethesda, MD 20892-7517
Tel: 301 435 3608
Email: Piccianm@od.nih.gov

2. Peer Review Contacts:

N/A

3. Financial or Grants Management Contacts:

From the Office of Research on Women’s Health:

Lisa Begg, Dr.P.H., R.N.
Office of Research on Women’s Health
Office of the NIH Director
6707 Democracy Blvd., Suite 400
MSC 5484
Bethesda, MD 20892-5484
Telephone: (301) 496-7853
Email:  beggl@od.nih.gov

National Cancer Institute (NCI) www.cancer.gov

Crystal Wolfrey
Office of Grants Administration
National Cancer Institute
6120 Executive Boulevard
EPS Suite 243, MSC 7150
Bethesda, MD 20892-7150 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Tel: (301) 496-8634
Fax: (301) 496-8601
E-mail: wolfreyc@mail.nih.gov

National Human Genome Research Insitute (NHGRI) www.genome.gov

Ms. Cheryl Chick
Grants Administration Branch
National Human Genome Research Institute
Suite 4076 - MSC 9306
5635 Fishers Lane
Bethesda, MD 20892-9306
Tel: (301) 435-7858
Fax: (301) 402-1951
Email: ChickC@mail.nih.gov

National Institute on Aging (NIA) www.nia.nih.gov

Richard E. Proper
Grants Management Specialist
Gateway Building
Room 2N212
7201 Wisconsin Avenue
Bethesda, MD, 20892-9205
Tel: 301-402-7735
Fax : 301-402-3672
Email: properr@nia.nih.gov

National Institute on Alcohol Abuse and Alcoholism (NIAAA) www.niaa.nih.gov

Ms. Judy Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3023
Bethesda, MD 20892-9304
Tel:  (301) 443-4704
Fax: (301) 443-3891
Email: jfox@mail.nih.gov

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) www.niams.nih.gov

Melinda B. Nelson
National Institute of Arthritis and Musculoskeletal and Skin Diseases
One Democracy Plaza
Suite 838
6701 Democracy Boulevard
Bethesda, MD 20892
Tel : 301 594 2463
Email : turkeltaubm@mai.nih.gov

National Institute of Biomedical Imaging and Bioengineering (NIBIB) www.nibib.nih.gov

Nancy Curling
Chief, Grants Management Office
Two Democracy Plaza
Suite 900
6707 Democracy Boulevard
Bethesda , MD, 20892
Tel: 301-451-4782
Fax: 301-480-4974
Email:curlingn@mail.nih.gov

National Institute of Child Health and Human Development (NICHD) www.nichd.nih.gov

Cecilia E. Bruce
Supervisory Grants Management Specialist (Team Leader)
National Institute of Child Health and Human Development
6100 Executive Boulevard
Room 8A17L
Rockville, Maryland 20852
Tel: (301) 496-1304
Fax: (301) 480-4782
E-Fax: (301) 451-5510
E-mail: brucec@mail.nih.gov

National Institute of Dental and Craniofacial Research (NICDR) www.nicdr.nih.gov

Mary Daley
Chief
Grants Management Branch
National Institute of Dental and Craniofacial Research
Building 45, Room 4AN 44B
45 Center Drive
Bethesda, MD 20892-6402
Tel: (301) 594-4808
Fax: (301) 480-3562
Email: Daleym@mail.nih.gov

National Institute on Drug Abuse (NIDA) www.nida.nih.gov

Yinka Abu
Grants Management Branch
National Institute on Drug Abuse
6101 Executive Blvd., Suite 270
Bethesda, MD 20892-8403
Tel: (301) 443-6710
Fax: 301-594-6847
Email: abuy@nida.nih.gov

National Institute of Environmental Health Sciences (NIEHS) www.niehs.nih.gov

Susan Ricci
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
79 TW Alexander Drive
Building 4401, Room 3408
Research Triangle Park, NC 27709
Tel:  (919) 316-4666
FAX:  (919) 541-2860
Email: ricci@niehs.nih.gov

National Institute of Mental Health (NIMH) www.mentalhealth.gov

Joy Knipple
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard
Room 6115
Bethesda, MD 20892-9659
Tel: (301) 443-8811

National Institute of Neurological Disorders and Stroke (NINDS) www.ninds.nih.gov

Tijuanna Decoster
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard
Bethesda, MD 20892-5484
Tel:  (301) 496-923
Fax:  (301) 402-021
E-mail:  decoster@ninds.nih.gov

National Library of Medicine (NLM) www.nlm.nih.gov

Ebony Simmons
Grants Management Specialist
NLM Extramural Programs
National Library of Medicine
Rockledge 1, Suite 301
6705 Rockledge Drive
Bethesda, MD 20892
Tel: 301-496-4221
Email: simmone1@mail.nih.gov

Fogarty International Center (FIC) www.fic.nih.gov

Elizabeth C. Cleveland
Grants Management Specialist
Fogarty International Center
Building 31, Room B2C29
31 Center Drive
Bethesda, MD 20892-2220
Tel: 301-451-6830
Fax: 301-594-1211
E-mail:clevelande@mail.nih.gov

National Center for Complementary and Alternative Medicine (NCCAM) www.nccam.nih.gov

George Tucker, MBA
Grants Management Office
National Center for Complementary and Alternative Medicine
6707 Democracy Boulevard, Suite 401
Bethesda, MD  20892-5475
Telephone: 301-594-8853
Fax: 301-480-2419
Email: gt35v@nih.gov

Office of Behavioral and Social Science Research (OD/OBSSR) Obssr.od.nih.gov

Patricia Mabry, Ph.D.
Office of Behavioral and Social Sciences Research
Office of the Director
National Institutes of Health
31 Center Drive,Building 31,Room B1C19
Bethesda, MD 20892
Tel: 301.402.1146
Email: mabryp@mail.nih.gov

Office of Dietary Supplements (OD/ODS) ods.od.nih.gov

Mary Frances Picciano, Ph.D
Senior Nutrition Specialist
Office of Dietary Supplements
Office of the Director
6100 Executive Boulevard
Room 3B01, MSC 7517
Bethesda, MD 20892-7517
Tel: 301 435 3608
Email: Piccianm@od.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 (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

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

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

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. 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) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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

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

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

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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