and Human Services (HHS)
EXPIRED
Department
of Health and Human Services
Participating Organizations
National
Institutes of Health (NIH) (http://www.nih.gov)
Components of
Participating Organizations
Office of 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/default.htm
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 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 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/
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
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-07-381
Catalog of Federal
Domestic Assistance Number(s)
93.393, 93.394, 93.395, 93.396, 93.399, 93.867, 93.233, 93.837, 93.838, 93.839,
93.172, 93.866, 93.273, 93.856, 93.846, 93.286, 93.865, 93.173, 93.121, 93.279, 93.113,
93.859, 93.242, 93.361, 93.879, 93.989, 93.213, 93.226
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).
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
Expiration Date: January 8, 2010
Due Dates for E.O. 12372
Not
Applicable
Additional
Overview Content
Executive Summary
Purpose. The purpose of this Funding Opportunity Announcement (FOA), issued by the Office of Research on Women s Health (ORWH) and co-sponsoring NIH institutes and centers (ICs), is to promote innovative, interdisciplinary research that will advance new concepts in women’s health research and the study of sex/gender differences. Recent research reports have established the importance of studying issues specific to women, including the scientific and clinical importance of analyzing data separately for females and males. ORWH is particularly interested in encouraging extramural investigators to undertake new interdisciplinary research to advance studies on how sex and gender factors affect women's health; however, applications in all areas of women’s health and/or sex/gender research are invited.
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 exploratory developmental program, using the R21 grant mechanism. This trans-NIH research program funding opportunity is called ANSWHR, Advancing Novel Science in Women’s Health Research. Using the R21 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.
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.
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 ResearchBasic, 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:
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 of Support
This FOA will use the NIH
Exploratory/Developmental Research Grant (R21) award
mechanism. As an applicant, you 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.
Exploratory/developmental grant support is for new projects only; competing renewal (formerly competing continuation ) applications will not be accepted. Up to two resubmissions (formerly revisions/amendments") of a previously reviewed exploratory/developmental grant application may be submitted. See NOT-OD-03-041, May 7, 2003.
2. Funds Available
During the first year of this announcement, ORWH and its IC scientific partners
anticipates having $2 to $2.5 million available for this PAS. 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. Awards pursuant to this funding opportunity are contingent upon the
availability of funds and the submission of a sufficient number of meritorious
applications.
The total project period for an application submitted in response to this funding opportunity may not exceed 2 years. Although the size of award may vary with the scope of research proposed, it is expected that applications will stay within the budgetary guidelines for an exploratory/developmental project; direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year award period. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
F&A costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November 2, 2004.
Section III. Eligibility Information
1.
Eligible Applicants
1.A. Eligible
Institutions
You may submit an application(s) if your institution/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 organization to develop an application for support.
Individuals from underrepresented racial and ethnic groups as well as
individuals with disabilities are always encouraged to apply for NIH support.
More than one PD/PI, or multiple PDs/PIs, may be
designated on the application for projects that require a team science approach
that clearly does not fit the single-PD/PI model. Additional
information on the implementation plans and policies and procedures to formally
allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA
Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The
decision of whether to apply for a single PD/PI or multiple PD/PI grant is the
responsibility of the investigators and applicant organizations and should be
determined by the scientific goals of the project. Applications for multiple
PD/PI grants will require additional information, as outlined in the
instructions below. The NIH review criteria for approach, investigators, and
environment have been modified to accommodate applications involving either a
single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be
aware that the structure and governance of the PD/PI leadership team as well as
the knowledge, skills and experience of the individual PD/PIs will be factored
into the assessment of the overall scientific merit of the application.
Multiple PDs/PIs on a project share the authority and responsibility for
leading and directing the project, intellectually and logistically. Each
PD/PI is responsible and accountable to the grantee organization, or, as
appropriate, to a collaborating organization, for the proper conduct of the
project or program, including the submission of required reports. For further
information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
2.
Cost Sharing or Matching
This program does not require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special
Eligibility Criteria
Applicants may submit more than one
application, provided each application is scientifically distinct.
Section IV. Application and Submission Information
To download a SF424 (R&R) Application Package and
SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for
this FOA, link to http://www.grants.gov/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 organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application Information
Applicants must download the SF424 (R&R)
application forms and 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: [email protected].
Telecommunications for the hearing impaired: TTY
301-451-5936.
2. Content and Form of Application Submission
Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).
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
Research & Related Subaward Budget Attachment(s)
Form
Foreign Organizations (Non-domestic
(non-U.S.) Entity)
NIH policies concerning grants to foreign (non-U.S.) organizations can be found
in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.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
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
electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.
3.C. Application
Processing
Applications may be submitted on or after
the opening date and must be successfully received by Grants.gov no
later than 5:00 p.m. local time (of the
applicant institution/organization) on the
application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s)
and time, the application may be delayed in the review process or not reviewed.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.
Upon receipt, applications will
be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete
applications will not be reviewed.
There will be an acknowledgement of receipt of
applications from Grants.gov and the Commons. 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 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.
PHS398 Research Plan Component Sections
While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
All application instructions outlined in the SF424 (R&R) Application Guide (MS Word or PDF) are to be followed, incorporating "Just-in-Time" information concepts, and with the following requirements for R21 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.
Note: While each section of the PHS398 Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to monitor better formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
Foreign Applications (Non-domestic (non-U.S.) Entity)
Plan for Sharing Research Data
N/A
Sharing Research Resources
NIH
policy expects that grant recipients make unique research resources readily
available for research purposes to qualified individuals within the scientific
community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each Non-Competing Grant
Progress Report (PHS 2590). See Section VI.3.,
Reporting.
Section V. Application Review Information
1. Criteria (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.
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 R21 exploratory/developmental grant is a mechanism for supporting novel scientific ideas or new model systems, tools, or technologies that have the potential to significantly advance our knowledge or the status of health-related research. Because the Research Plan component is limited to 15 pages, an exploratory/developmental grant application need not have extensive background material or preliminary information as one might normally expect in an R01 application. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will place 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, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.
The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.
Note that an application does not
need to be strong in all categories to be judged likely to have major
scientific impact and thus deserve a high priority score. For example, an
investigator may propose to carry out important work that by its nature is not
innovative but is essential to move a field forward.
Significance: Does this study address an
important problem? If the aims of the application are achieved, how will
scientific knowledge or clinical practice be advanced? What will be the effect
of these studies on the concepts, methods, technologies, treatments, services,
or preventative interventions that drive this field?
Approach: Are the conceptual or clinical framework, design, methods, and
analyses adequately developed, well integrated, well reasoned, and appropriate
to the aims of the project? Does the applicant acknowledge potential problem
areas and consider alternative tactics?
Innovation: Is the project original and innovative? For example: Does
the project challenge existing paradigms or clinical practice; address an
innovative hypothesis or critical barrier to progress in the field? Does the
project develop or employ novel concepts, approaches, methodologies, tools, or
technologies for this area?
Investigators: Are the PD/PIs 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/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
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 R21
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.
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:
Lisa Begg, Dr.P.H., R.N.
Director of
Research Programs
Office of
Research on Women’s Health/OD
National
Insitutes of Health
6707 Democracy Boulevard, Suite 400, MSC 5484
Bethesda, MD 20892-5484 (For overnight mail only,
please use Bethesda, MD. 20817)
Phone:
(301) 496-7853 (direct)
General ORWH phone
Number : (301) 402-1770
E-mail: [email protected]
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: [email protected]
National Eye Institute
(NEI) www.nei.nih.gov
Jerome
R. Wujek, Ph.D.Research Resource Officer
Division of Extramural
Research
Vision Research Program
National Eye Institute
5635 Fishers Lane, Suite 1300
Rockville, MD 20852
Tel :
301 451 2020
Email : [email protected]
National Heart Lung and Blood Institute (NHLBI) www.nhlbi.nih.gov
Jacques E. Rossouw, MD
Chief, Women's Health Initiative Branch
Division of Prevention and Population Sciences, NHLBI
6701 Rockledge Drive, Suite 8204, MSC 7935
Bethesda, MD 20892-7935
Phone: (301) 402-2900
Fax: (301) 480-5158
Email: [email protected]
National Human Genome Research Institute (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:
[email protected]
National Institute on Aging (NIH/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: [email protected]
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: [email protected]
National Institute of Allergy and Infectious Diseases (NIAID) www.niaid.nih.gov
Tamara Lewis-Johnson
National Institute of Allergy and Infectious Diseases
Office of Special
Populations and Research Training
6700B Rockledge Drive
Suite 2104
Bethesda,
MD 20852
Tel: 301 451 7942
E-mail:[email protected]
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 : [email protected]
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:
[email protected]
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: [email protected]
National Institute on Deafness and Other Communication Disorders (NIDCD) www.nidcd.nih.gov
Lana Shekim, Ph.D.
Scientific Programs Division
National Institute on
Deafness and Other Communication Disorders
Executive Plaza South,
400C
6120 Executive Boulevard
Rockville, MD 20852
Tel : 301 496
5061
Email: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
National Institute of General Medical Sciences (NIGMS) www.nigms.nih.gov
Rochelle
M. Long, Ph.D.
National
Institute of General Medical Sciences
45
Center Drive
Room
2AS-49G
Bethesda, MD 20892-6200
Tel:
(301) 594-3827
Fax:
(301) 480-2802
E e-mail: [email protected]
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: [email protected]
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: [email protected]
National Institute of Nursing Research (NINR) www.ninr.nih.gov
Dr. Linda S. Weglicki, PhD, RN, MSN
Program Director, Office of Extramural Activities
National Institute of Nursing Research, NIH
6701 Democracy Blvd., Suite 710
One Democracy Plaza
Bethesda, MD 20892-4870
Telephone: (301) 594-6908
Fax: (301) 480-8260
Email: [email protected]
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:
[email protected]
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 : [email protected]
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 : [email protected]
Office of Behavioral and Social Sciences Research (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:
[email protected]
Office of Dietary Supplements (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: [email protected]
2. Peer Review Contacts:
NA
3. Financial or Grants
Management Contacts:
Lisa Begg, Dr.P.H., R.N.
Director of
Research Programs
Office of
Research on Women’s Health/OD
National
Insitutes of Health
6707 Democracy
Boulevard, Suite 400, MSC 5484
Bethesda, MD 20892-5484 (For overnight mail only,
please use Bethesda, MD. 20817)
Phone:
(301) 496-7853 (direct)
General ORWH phone
Number : (301) 402-1770
E-mail: [email protected]
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:
[email protected]
National Eye Institute (NEI) www.nei.nih.gov
Mr.
William Darby
Chief,
Grants Management Branch
National
Eye Institute
5635
Fishers Lane
Suite 1300
Bethesda, MD 20892-9300
Tel: 301-451-2020
Fax: 301-496-9997
Email: [email protected]
National Heart Lung and Blood Institute (NHLBI) www.nhlbi.nih.gov
Ryan C. Lombardi
Grants Management Specialist
National Heart Lung and
Blood Institute
Two Rockledge Center,
Room 7162
6701 Rockledge Drive
Bethesda, MD 20892
Tel :
301 435 0141
Email :
[email protected]
National Human Genome Research Institute (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:
[email protected]
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:
[email protected]
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: [email protected]
National Institute of Allergy and Infectious Diseases (NIAID) www.niaid.nih.gov
Lesia
A. Norwood
Deputy
Chief, Grants Management Program
Room
2116
6700B
Rockledge Drive, MSC 7614
Bethesda, MD 20892-7614
Phone:
301-402-7146
eFax:
301-493-0597
email: [email protected]
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 : [email protected]
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:[email protected]
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:
[email protected]
National Institute on Deafness and Other Communication Disorders (NIH/NIDCD) www.nidcd.nih.gov
Christopher Myers
Division of Extramural
Activities
National Institute on
Deafness and Other Communication Disorders
6120 Executive Boulevard,
EPS 400C ,MSC 7180
Bethesda, MD 20892-7180
Tel: (301) 402-0909
Fax: 301 402 1758
Email: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
National Institute of General Medical Sciences (NIGMS) www.nigms.nih.gov
Lisa
Moeller
MSC
6200
45
Center Drive
Bethesda, MD, 20892-6200
tel:
301.594.3914
fax:
301.451.5601
email:
[email protected]
National Institute of Mental Health (NIH/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: [email protected]
National Institute of Nursing Research (NINR) www.ninr.nih.gov
Brian
Albertini
Office of Grants and
Contract Management
National Institute
of Nursing Research
One Democracy Plaza, 710
6701 Democracy Blvd
Bethesda,
MD 20892
Tel :
301-594-6869
Email :
[email protected]
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: [email protected]
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:[email protected]
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: [email protected]
Office of Behavioral and Social Sciences Research (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: [email protected]
Office of Dietary Supplements (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: [email protected]
Section VIII. Other Information
Required Federal Citations
Use of Animals in
Research:
Recipients of PHS support for activities involving
live, vertebrate animals must comply with PHS Policy on Humane Care and Use of
Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects Protection:
Federal regulations (45 CFR 46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative
trials (Phase III). Monitoring should be commensurate with risk. The
establishment of data and safety monitoring boards (DSMBs) is required for
multi-site clinical trials involving interventions that entail potential risks
to the participants ( NIH Policy for Data and Safety Monitoring, NIH Guide
for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators 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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