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), (http://www.cancer.gov/)
National Eye Institute (NEI), (http://www.nei.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 on Aging (NIA), (http://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov/)
National Institute of Allergy and Infectious Diseases (NIAID),(http://www.niaid.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.nibib.nih.gov)
Eunice Kennedy Shriver National Institute of Child Health  and Human Development (NICHD), (http://www.nichd.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD), (http://www.nidcd.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://www2.niddk.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 General Medical Sciences (NIGMS), (http://www.nigms.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 Institute of Nursing Research (NINR), (http://www.ninr.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/)
National Center on Minority Health and Health Disparities (NCMHD) (http://www.ncmhd.nih.gov)
Office of Behavioral and Social Science Research (OBSSR), (http://obssr.od.nih.gov/)
Office of Dietary Supplements (ODS), (http://ods.od.nih.gov/)

Title:  Advancing Novel Science in Women’s Health Research (ANSWHR) (R21)

Announcement Type
This Funding Opportunity Announcement (FOA) is a reissue of PAS-07-381.

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

Program Announcement (PA) Number: PAS-10-226

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

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

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

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

Catalog of Federal Domestic Assistance Number(s)
93.113, 93.121, 93.172, 93.173, 93.213, 93.242, 93.273, 93.279, 93.286, 93.307, 93.361, 93.393,  93.394,  93.395,  93.396,  93.399, 93.837, 93.846, 93.847, 93.853, 93.855, 93.856, 93.859, 93.866, 93.865, 93.867, 93.879, 93.989 

Key Dates
Release/Posted Date: July 1, 2010
Opening Date:  September 16, 2010 (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 Due Date(s): October 16, 2010; October 16, 2011, October 16, 2012 for new applications; November 16, 2010; November 16, 2011; November 16, 2012 for resubmission applications   
AIDS Application Due Date(s):  January 7, 2011; January 7, 2012; January 7, 2013
Peer Review Date(s): February/March 2011; February/March 2012; February/March 2013
Council Review Date(s): May 2011; May 2012; May 2013
Earliest Anticipated Start Date(s): July 1, 2011; July 1, 2012; July 1, 2013
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: January 8, 2013

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
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contacts
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Purpose

The purpose of this R21 funding opportunity announcement (FOA) 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 the scientific partnering Institutes and Centers across the NIH are interested particularly in encouraging investigators to undertake new interdisciplinary research to advance studies on the differential affects of sex and gender upon women's health. 

Background

The ORWH  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 that examined research needs for women's health.  The recommendations from these national meetings indicated a need for research on certain scientific areas, sex and gender perspectives throughout the life span, and differences among populations of women.  The executive summary of these outcomes is available at the following URL:  http://orwh.od.nih.gov/research/resagenda.html.

The  2001 Institute of Medicine (IOM) report "Exploring the Biological Contributions to Human Health, Does Sex Matter?" highlighted that:

This IOM report also discussed 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 encouraged.

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

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 increasingly scientifically convincing.  Basic, clinical and translational research must be considered in addressing priority areas in women’s health research.

Research Objectives and Scope

The ORWH establishes areas of emphasis based on ORWH and IOM reports (see above), input from periodic strategic planning workshops and recommendations from the Coordinating Committee on Research on Women's Health (CCRWH), composed of representatives from the NIH Institutes and Centers (http://orwh.od.nih.gov/research/priorities.html).  Since these areas of emphasis may change during the course of this FOA, applicants are encouraged to review the ORWH website and discuss the proposed research with NIH Program staff well in advance of responding to this FOA.  Priority areas for ANSWHR represent approaches and specific topics for which there is a need to stimulate and encourage research on women’s health, or sex/gender factors. 

Areas of interest include, but are not limited to the following: 

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:  Sex and gender 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, proposed basic and 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.

Diseases and Conditions that Affect Women:  Investigate the pathogenesis and develop preventive and therapeutic interventions for acute and chronic diseases and disorders that affect women including, but not limited to, metabolic, inflammatory, endocrine, autoimmune, gastrointestinal, liver, urologic, ophthalmic, oral, reproductive, musculoskeletal, neurological, psychiatric, and cardiovascular diseases.

Methodological Advances: Develop clinical trial methodology, including novel recruitment strategies, standardized outcome strategies, and statistical analyses that address ethical and study design issues specific to studies of women.  Develop new methodologies for animal model studies of the normal development of women, and their health and diseases, including female animal models.  Methodological studies related to the conceptualization, distinction and detection of sex and gender differences in basic and clinical biomedical research.

Quality of Life:  Elucidate the unique sex and gender factors affecting women’s quality of life.  Develop approaches to management of disease and promotion of wellness that are directed at women and their unique issues. 

Prevention, Treatment and Treatment Outcomes:  The NIH is interested 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.  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. 

Biological and Behavioral Basis of Sex and Gender Differences:   While 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.  In this regard, studies on the role of sex in areas such as pharmacogenomics, epigenetics and stem cells/tissue regeneration are encouraged.  Systemic and cellular modeling of the influence of sex differences in biological pathways and systems is needed. 

Institute/Center-Specific Research Interests and Requests

In addition to the research objectives listed above, the following NIH Institutes and Centers include the following guidance:

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.

The R21 Award Mechanism

The evolution and vitality of the biomedical sciences require a constant infusion of new ideas, techniques, and points of view. These may differ substantially from current thinking or practice and may not yet be supported by substantial preliminary data. By using the R21 mechanism, the NIH seeks to foster the introduction of novel scientific ideas, model systems, tools, agents, targets, and technologies that have the potential to substantially advance biomedical research. 

The R21 mechanism is intended to encourage new exploratory and developmental research projects. For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research. Another example could include the unique and innovative use of an existing methodology to explore a new scientific area. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research.

Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism. For example, long-term projects, or projects designed to increase knowledge in a well-established area, will not be considered for R21 awards. Applications submitted under this mechanism should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications. 

Note about Review and Administration of this PAS

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 the Center for Scientific Review.  Applications will then undergo standard NIH scientific review using established IRG groups. After scientific review and institute/center council review/approval, ORWH will transfer funds to the primary IC 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.

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

Section II. Award Information


1. Mechanism of Support

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

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

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.

2. Funds Available

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the Institutes and Centers (ICs) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

The total project period for an application submitted in response to this funding opportunity may not exceed 2 years. Although the size of award may vary with the scope of research proposed, it is expected that applications will stay within the budgetary guidelines for an exploratory/developmental project; direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year award period. NIH grants policies as described in the NOT-OD-05-004.

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 $4 million for fiscal year 2011. Future year amounts will depend on annual appropriations.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

1.B. Eligible Individuals

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

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

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

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit more than one application, provided that each application is scientifically distinct.  

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

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

Section IV. Application and Submission Information


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

Registration:

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

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

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

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

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

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.

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

1. Request Application Information

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

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

For further assistance, contact GrantsInfo -- Telephone 301-435-0714, 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 for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).

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

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

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

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

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

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/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 (U.S.) or that augment existing U.S. resources.

SPECIAL INSTRUCTIONS  

Applications with Multiple PDs/PIs

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

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

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

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

Applications Involving a Single Institution

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

Applications Involving Multiple Institutions 

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form. 

When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 5.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review and Anticipated Start Dates
Opening Date:  September 16, 2010 (Earliest date an application may be submitted to Grants.gov)
Application Due Date(s): October 16, 2010; October 16, 2011, October 16, 2012 for new applications; November 16, 2010; November 16, 2011; November 16, 2012 for resubmission applications   
AIDS Application Due Date(s):  January 7, 2011; January 7, 2012; January 7, 2013
Peer Review Date(s): ): February/March 2011; February/March 2012; February/March 2013
Council Review Date(s): May 2011; May 2012; May 2013
Earliest Anticipated Start Date(s): July 1, 2011; July 1, 2012; July 1, 2013

3.A.1. Letter of Intent

A letter of intent is not required for this 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 electronically.  PAPER APPLICATIONS WILL NOT BE ACCEPTED.  All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
 
3.C. Application Processing

3.C.1 Submitting On-Time

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

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

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

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

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

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

Please note that the following caveats apply:

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

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

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

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

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions


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

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See the NIH Grants Policy Statement.

6. Other Submission Requirements

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

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

Organizational DUNS

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

PHS398 Research Plan Component Sections

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

Budget Component          

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

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.

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

Appendix Materials 

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

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

Resource Sharing Plan(s)

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

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact (see Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.)

 (b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition.  For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (go to NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.)

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

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

Section V. Application Review Information


1. Criteria 

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

2. Review and Selection Process

Review Process

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

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

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

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

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability.  As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system. 

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed). 

Scored Review Criteria

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each.  An application does not need to be strong in all categories to be judged likely to have major scientific impact.  For example, a project that by its nature is not innovative may be essential to advance a field.

Significance.  Does the project address an important problem or a critical barrier to progress in the field?  If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?  How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s).  Are the PD/PIs, collaborators, and other researchers well suited to the project?  If Early Stage Investigators or New Investigators, do they have appropriate experience and training?  If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?  If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation.  Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?  Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?  Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach.  Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?   If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment.  Will the scientific environment in which the work will be done contribute to the probability of success?  Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?  Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? 

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects.  For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects  and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children.  When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals.  The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.  For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

Biohazards.  Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

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

Renewal Applications.  Renewals are not allowed for this FOA.

Revision Applications.  Revisions are not allowed for this FOA.

Additional Review Considerations

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations.  As applicable for the FOA or submitted application, reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans.  Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

Budget and Period Support.  Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Selection Process

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

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 E-mail notification from the awarding component to the grantee business official.

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

2. Administrative and National Policy Requirements

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

3. Reporting

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

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

Section VII. Agency Contacts


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

1. Scientific/Research Contacts:

Office of Research on Women’s Health (ORWH) orwh.od.nih.gov

Lisa Begg, Dr.P.H., R.N.
Director of Research Programs
Office of Research on Women’s Health/OD/NIH
6707 Democracy Boulevard, Suite 400
Bethesda, MD 20892-5484 (For overnight mail, please use Bethesda, MD. 20817) 
Phone:  301-496-7853 (direct) ;  301-402-1770 (ORWH phone number)
E-mail: 
beggl@od.nih.gov

Dennis Mangan, Ph.D.
Senior Research Advisor
Office of Research on Women’s Health/OD/NIH
6707 Democracy Boulevard, Suite 400
Bethesda, MD 20892-5484 (For overnight mail, please use Bethesda, MD. 20817) 
Phone:  301-496-9006 (direct) ; 301-402-1770 (ORWH phone number)
E-mail: 
Dennis.Mangan@nih.gov

National Cancer Institute (NCI) www.cancer.gov

Karen Parker, Ph.D.
Women’s Health Officer
Office of Science Planning and Assessment/NCI
6116 Executive Boulevard, Suite 205
Rockville, MD 20892
Phone:  301-451-9462
E-mail:  klparker@mail.nih.gov

National Eye Institute (NEI)  www.nei.nih.gov

Lisa A. Neuhold, Ph.D.
Division of Extramural Research/NEI
5635 Fishers Lane, Suite 1300
Bethesda, MD 20892-9300
Phone: 301-451-2020
FAX: 301-402-0528
E-mail: lneuhold@mail.nih.gov

National Heart Lung and Blood Institute (NHLBI) www.nhlbi.nih.gov

Shari Eason Ludlam, MPH
Two Rockledge Center, Room 9188/NHLBI
6701 Rockledge Drive
Bethesda, MD 20892
Phone: 301-435-6667  
E-mail :
ludlams@nhlbi.nih.gov

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

Bettie J.Graham, Ph.D.
Program Director/NHGRI
5635 Fishers Lane, Suite 4076
Bethesda, MD 20892-9306
Phone:  301-496-7531
E-mail:
bettie_graham@nih.gov

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

Sherry Sherman, Ph.D.
Geriatrics and Clinical Gerontology Program/NIA
Gateway Building, 3C307
7201 Wisconsin Avenue
Bethesda, MD  20892-9205
Phone: 301-435-3048
E-mail: shermans@nia.nih.gov

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

Svetlana Radaeva, Ph.D.
Division of Metabolism and Health Effects/NIAAA
5635 Fishers Lane
Rockville, MD 20852
Phone: 301-443-1189
E-mail: sradaeva@mail.nih.gov

National Institute of Allergy and Infectious Diseases (NIAID) www.niaid.nih.gov

Tamara Lewis-Johnson
Office of Special Populations and Research Training/NIAID
6700B Rockledge Drive, Suite 2104
Bethesda, MD 20852
Phone: 301-451-7942
E-mail: lewisjohnsont@niaidi.nih.gov

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

Bernadette Tyree, Ph.D.
Director, Cartilage and Connective Tissue Program/NIAMS
6701 Democracy Blvd., Suite 800
Bethesda, MD 20892-4872
Phone: 301-594-5055

FAX:  301-480-1284
E-mail: tyreeb@mail.nih.gov

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

Rosemarie Hunziker, PhD
Program Director, Tissue Engineering and Regenerative Medicine/NIBIB
6707 Democracy Boulevard, Room 235 
Bethesda, MD  20892-5477
Phone:  301-451-1609
E-mail:  hunzikerr@mail.nih.gov

Eunice Kennedy Shriver 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/NICHD
6100 Executive Blvd, Executive Bldg, 8B01
Bethesda, MD  20892-7510
Phone:  301-435-6971
E-mail:
parrotte@mail.nih.gov

National Institute on Deafness and Other Communication Disorders (NIDCD) www.nidcd.nih.gov

Lana Shekim, Ph.D.
Division of Scientific Programs/NIDCD
Executive Plaza South, 400-C
6120 Executive Boulevard
Rockville, MD 20852
Phone : 301-496-5061
E-mail:
shekiml@nidcd.nih.gov

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

Jane Atkinson, D.D.S.
Director, Center for Clinical Research/NIDCR
6701 Democracy Blvd, Room 634
Bethesda, MD 20892-4878
Phone: 301-435-7908
FAX: 301-480-8322
E-mail: jatkinso@mail.nih.gov

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) www2.niddk.nih.gov/

Mary E. Evans, Ph.D.
Director, Special Projects in Nutrition, Obesity, and Digestive Diseases
Division of Digestive Diseases and Nutrition/NIDDK
6707 Democracy Blvd, Room 681
Bethesda, Maryland 20892-5450  (For UPS, FedEx: use 20817)
Phone: 301-594-4578
FAX: 301-480-8300
E-mail: evansmary@niddk.nih.gov

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

Cora Lee Wetherington, PhD
Women & Sex/Gender Differences Research Coordinator/NIDA
6001 Executive Boulevard, Rm 4282
Bethesda, MD 20892-9555 (For deliveries:  Rockville, MD 20852)
Phone: 301-435-1319
E-mail: cwetheri@nida.nih.gov

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

Jerrold (Jerry) Heindel, Ph.D.
Chief, Cellular, Organs and Systems Pathobiology Branch
Division of Extramural Research and Training/NIEHS
POB 12233  MD K3-15
Research Triangle Park, NC, 27709; For express mail: 530 Davis Drive MD K3-15, Morrisville, NC  27560
Phone: 919-541-0781
FAX:  919-541-5064
Email: heindelj@niehs.nih.gov

National Institute of General Medical Sciences (NIGMS) www.nigms.nih.gov 

Paula Flicker, Ph.D.
45 Center Drive, 2AS-13H
Bethesda, MD, 20892-6200
Phone: 301-594-0828
FAX: 301-480-2004
E-mail:
flickerp@nigms.nih.gov

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

Kathleen O’Leary, M.S.W.
Acting Chief, Women's Program
Office for Research on Disparities and Global Mental Health/NIMH
6001 Executive Boulevard, Room 8125
Rockville MD 20892-9659
Phone: 301-443-3945
FAX:  301-443-8552
E-mail: Olearyk@mail.nih.gov

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

Linda Porter, Ph.D.
6001 Executive Boulevard/NINDS
Bethesda, MD 20892-5484
Phone:  301-496-9964
FAX: 
 301 402 2656
E-mail: 
porterl@ninds.nih.gov

National Institute of Nursing Research (NINR) www.ninr.nih.gov

Xenia T. Tigno, Ph.D., M.S. (Physio), M.S.(Epi)
Program Director
Office of Extramural Programs/NINR
6701 Democracy Blvd., Suite 710
Bethesda, MD 20892-4870
Phone: 301- 594-2775
FAX: 301-480-8260
E-mail: tignoxt@mail.nih.gov

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

Dr. Hua-Chuan Sim
NLM Extramural Programs/NLM
Rockledge One, Suite 301
6705 Rockledge Drive
Bethesda, MD 20892-7968
Phone: 301-594-4882
E-mail: simh@mail.nih.gov

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

Kathleen Michels, Ph.D.
Program Director
Division of International Training and Research/FIC
Building 31, Room B2C39r
31 Center Drive
Bethesda, MD 20892-2220
Phone: 301-496-1653
FAX: 301-402-0779
E-mail: michelsk@nih.gov

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

Shiela A. Caldwell, Ph.D.
Program Director
Special Populations
Division of Extramural Research/NCCAM
6707 Democracy Boulevard, Suite 401
Bethesda, MD 20892-5475
Phone: 301-594-3396

FAX: 301-480-3621 
E-mail :
caldwells@mail.nih.gov

National Center on Minority Health and Health Disparities (NCMHD) http://www.ncmhd.nih.gov

Derrick C. Tabor, Ph.D.
Program Director, Center of Excellence Program
Office of Scientific Programs, DEASP
Suite 800, 6707 Democracy Blvd.
Bethesda, MD 20892-5465
Phone: 301-594-8950
Fax: 301-480-4840
E-mail: tabord@mail.nih.gov 

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

Lisa Begg, Dr.P.H., R.N. (accepting calls for OBSSR)
Director of Research Programs
Office of Research on Women’s Health/OD/NIH
6707 Democracy Boulevard, Suite 400
Bethesda, MD 20892-5484 (For overnight mail, please use Bethesda, MD. 20817) 
Phone:  301-496-7853 (direct) ;  301-402-1770 (ORWH phone number)
E-mail: 
beggl@od.nih.gov

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

Rebecca B. Costello, Ph.D., F.A.C.N.
Director, Grants and Extramural Programs
Office of Dietary Supplements/OD/NIH
6100 Executive Blvd., Room 3B01
Bethesda, Maryland 20892-7517
Phone: 301-435-2920
FAX: 301-480-1845
CostellB@od.nih.gov

2. Peer Review Contacts:

Not Applicable

3. Financial or Grants Management Contacts:

Office of Research on Women’s Health (ORWH) orwh.od.nih.gov/

Lisa Begg, Dr.P.H., R.N.
Director of Research Programs
Office of Research on Women’s Health/OD/NIH
6707 Democracy Boulevard, Suite 400
Bethesda, MD 20892-5484 (For overnight mail, please use Bethesda, MD. 20817) 
Phone:  301-496-7853 (direct) ;  301-402-1770 (ORWH phone number)
E-mail: 
beggl@od.nih.gov

National Cancer Institute (NCI) www.cancer.gov

Crystal Wolfrey
Office of Grants Administration/NCI
6120 Executive Boulevard
Executive Plaza South, Suite 243
Bethesda, MD 20892-7150 (For U.S. Postal Service express or
regular mail)
Rockville, MD 20852 (for express/courier delivery)
Phone: 301-496-8634
FAX: 301-496-8601
E-mail:
wolfreyc@mail.nih.gov

National Eye Institute (NEI)  www.nei.nih.gov

Mr. William W. Darby
Division of Extramural Research/NEI
5635 Fishers Lane; Suite 1300
Bethesda, MD 20892-9300
Phone: 301-451-2020
FAX: 301-496-9997
E-mail: wwd@nei.nih.gov

National Heart Lung and Blood Institute (NHLBI) www.nhlbi.nih.gov

Kimberly O.Stanton
Grants Management Specialist
Office of Grants Management/NHLBI
Rockledge II Center
6701 Rockledge Drive, Suite 7167
Bethesda, MD 20892 (express zip 20817)
Phone:  301-435-0159 (Direct)
FAX:  301-451-5462
E-mail:  stantonk@mail.nih.gov

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

Cheryl Chick
Grants Administration Branch/NHGRI
Suite 4076
5635 Fishers Lane
Bethesda, MD 20892-9306
Phone:  301-435-7858
FAX:  301-402-1951
E-mail:
ChickC@mail.nih.gov

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

Richard E. Proper
Grants Management Specialist/NIA
Gateway Building, Room 2N212
7201 Wisconsin Avenue
Bethesda, MD, 20892-9205
Phone: 301-402-7735
FAX : 301-402-3672
E-mail:
properr@nia.nih.gov

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

Judy Fox
Chief, Grants Management Branch/NIAAA
5635 Fishers Lane, Room 3023
Bethesda, MD 20892-9304
Phone:  301-443-4704
FAX: 301-443-3891
E-mail: 
jfox@mail.nih.gov

National Institute of Allergy and Infectious Diseases (NIAID) www.niaid.nih.gov

Lesia A. Norwood
Deputy Chief, Grants Management Program/NIAID
6700B Rockledge Drive, Room 2116
Bethesda, MD  20892-7614
Phone:  301-402-7146
eFAX:  301-493-0597
E-mail: 
ln5t@nih.gov

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

Andrew Jones
Deputy Grants Management Officer/NIAMS
6701 Democracy Boulevard, Suite 834
Bethesda, MD 20892-4872
Phone: 301-435-0610
FAX: 301-480-5450
E-mail:  jonesan@mail.nih.gov

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

Nancy Curling
Chief, Grants Management Office
Two Democracy Plaza
6707 Democracy Boulevard, Suite 900
Bethesda , MD, 20892-5469
Phone: 301-451-4782
FAX: 301-480-4974
E-mail:
curlingn@mail.nih.gov

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

Bryan S. Clark, MBA
Chief, Grants Management Officer/NICHD
6100 Executive Boulevard, Room 8A01A
Rockville, Maryland 20852
Phone: 301-435-6975
E-FAX: 301-451-5510
E-mail:
clarkb1@mail.nih.gov

National Institute on Deafness and Other Communication Disorders (NIDCD) www.nidcd.nih.gov

Christopher Myers
Division of Extramural Activities/NIDCD
6120 Executive Boulevard, EPS 400C
Bethesda, MD 20892-7180
Phone:  301-402-0909
FAX: 301-402-1758
E-mail:
Myersc@mail.nih.gov

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

Mary Greenwood
Chief, Grants Management Branch/NIDCR
6701 Democracy Blvd, Room 658
Bethesda, MD 20892-4878
Phone:  301-594-4808
FAX: 301-480-3562
E-mail: d
aleym@mail.nih.gov

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK/NIH), www2.niddk.nih.gov

Desiree Tubb
Grants Management Branch/NIDDK
2 Democracy Plaza
6707 Democracy Boulevard, Room #712B
Bethesda, MD 20892
Phone: 301-402-9285
FAX: 301-594-9523
E-mail: tubbda@mail.nih.gov

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

Yinka Abu
Grants Management
Branch/NIDA
6001 Executive Blvd,
Rockville, MD 20852
Phone number: 301-595-0572
E-mail: abuy@nida.nih.gov

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

Wanda Boggs
Grants Management Specialist
Grants Management Branch/NIEHS
530 Davis Drive
Keystone Building, Room 3063, MD  K3-11
Research Triangle Park, NC 27709-2233
Phone:  919-316-4638
FAX:  301-451-5334
E-mail: boggsw@niehs.nih.gov

National Institute of General Medical Sciences (NIGMS) www.nigms.nih.gov

Lisa Moeller
45 Center Drive, Room 2AN-50C
Bethesda, MD, 20892-6200
Phone: 301-594-3914
FAX: 301-451-5601
E-mail:
moellerl@mail.nih.gov

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

Joy R. Knipple
Division of Extramural Activities/NIMH
6001 Executive Boulevard, Room 6131
Bethesda, MD  20892-9605
Rockville, MD 20852 (For express/courier service)
Phone:  301-443-8811
FAX:  301-443-6885
E-mail:  jk173r@nih.gov

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

Tijuanna Decoster
6001 Executive Boulevard/NINDS
Bethesda, MD 20892-5484
Phone:  301-
496 9231
FAX:  301-
402 0219
E-mail: 
decoster@ninds.nih.gov

National Institute of Nursing Research (NINR) www.ninr.nih.gov

Brian Albertini
Office of Grants and Contract Management/NINR
One Democracy Plaza
6701 Democracy Blvd, Room 710
Bethesda, MD 20892-4870
Phone: 301-594-6869
E-mail:
Albertib@mail.nih.gov

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

Ebony Simmons
Grants Management Specialist

Extramural Programs/NLM
Rockledge 1, Suite 301
6705 Rockledge Drive
Bethesda, MD 20892-7968
Phone: 301-496-4221
E-mail:
simmone1@mail.nih.gov

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

Elizabeth C. Cleveland
Grants Management Specialist/FIC
Building 31, Room B2C29
31 Center Drive
Bethesda, MD  20892-2220
Phone: 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/NCCAM
6707 Democracy Boulevard, Suite 401
Bethesda, MD  20892-5475
Phone: 301-594-8853
FAX: 301-480-2419
E-mail:
gt35v@nih.gov

National Center on Minority Health and Health Disparities (NCMHD) http://www.ncmhd.nih.gov

Priscilla Grant, J.D., C.R.A.
Chief Grants Management Officer
6707 Democracy Boulevard, Suite 800
Bethesda, Maryland 20892-5465
Phone: 301-594-8412
Fax:  301-480-4049
E-mail:  pg38h@nih.gov

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

Lisa Begg, Dr.P.H., R.N. (accepting calls for OBSSR)
Director of Research Programs
Office of Research on Women’s Health/OD/NIH
6707 Democracy Boulevard, Suite 400
Bethesda, MD 20892-5484 (For overnight mail, please use Bethesda, MD. 20817) 
Phone:  301-496-7853 (direct) ;  301-402-1770 (ORWH phone number)
E-mail: 
beggl@od.nih.gov

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

Rebecca B. Costello, Ph.D., F.A.C.N.
Director, Grants and Extramural Programs/ODS/OD
6100 Executive Blvd., Room 3B01
Bethesda, Maryland 20892-7517
Phone: 301-435-2920
FAX: 301-480-1845
CostellB@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 (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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