EXPIRED
Office of Research on Women’s Health (ORWH)
National Cancer Institute (NCI)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute ( NHLBI )
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human
Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Mental Health (NIMH)
National Institute of Nursing Research (NINR)
National Library of Medicine (NLM)
National Institute on Minority Health and Health Disparities (NIMHD)
National Institute of Neurological Disorders and Stroke (NINDS)
Division of Program Coordination, Planning and Strategic
Initiatives, Office of Research Infrastructure Programs (ORIP)
National Center for Complementary and Integrative Health ( NCCIH )
Administrative Supplement for Research on Sex/Gender Influences (Admin Supp Clinical Trial Optional)
Administrative Supplement
Additional funds may be awarded as supplements to parent awards using the following Activity Code(s):
Administrative supplement requests must be submitted on paper for the following activity codes:
P01 Research Program Projects
P20 Exploratory Grants
P30 Center Core Grants
P40 Animal (Mammalian and Nonmammalian) Model, and Animal and Biological Material
Resource Grants
P41 Biotechnology Resource Grants
P50 Specialized Center
P51 Primate Research Center Grants
P60 Comprehensive Center
PM1 Program Project or Center with Complex Structure
U10 Cooperative Clinical Research Cooperative Agreements
U19 Research Program Cooperative Agreements
U54 Specialized Center- Cooperative Agreements
U56 Exploratory Grants Cooperative Agreements
UM2 Program Project or Center with Complex Structure Cooperative Agreement
Administrative supplement requests may be submitted electronically for the following activity codes:
DP1 NIH Director’s Pioneer Award (NDPA)
DP2 NIH Director’s New Innovator Awards
DP4 NIH Director’s Pathfinder Award- Multi-Yr Funding
DP5 Early Independence Award
K08 Clinical Investigator Award (CIA)
K23 Mentored Patient-Oriented Research Career Development Award
K76 Emerging Leaders Career Development Award
RM1 Research Project with Complex Structure
R01 Research Project Grant
R03 Small Grant Program
R21 Exploratory/Developmental Research Grant Award
R21/R33 Phased Innovation Award
R24 Resource-Related Research Projects
R37 Method to Extend Research in Time (MERIT) Award
R41 Small Business Technology Transfer (STTR) Grant - Phase I only
R41/R42 Small Business Technology Transfer (STTR) Grant - Phase I, Phase II, and
Fast-Track
R41/R42 Small Business Technology Transfer (STTR) Grant - Phase I and Phase II
R42 Small Business Technology Transfer (STTR) Grant - Phase II only
R43 Small Business Innovation Research (SBIR) Grant - Phase I only
R43/R44 Small Business Innovation Research (SBIR) Grant - Phase I, Phase II, and
Fast-Track
R43/R44 Small Business Innovation Research (SBIR) Grant - Phase I and Phase II
R44 Small Business Innovation Research (SBIR) Grant - Phase II only
U01 Research Project Cooperative Agreements
U44 Small Business Innovation Research (SBIR) Cooperative Agreements - Phase II
UG1 Clinical Research Cooperative Agreements - Single Project
UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreement
UH2 Exploratory/Developmental Cooperative Agreement Phase I
UH2/UH3 Phase Innovation Awards Cooperative Agreement
UH3 Exploratory/Developmental Cooperative Agreement Phase II
UM1 Multi-Component Research Project Cooperative Agreements
Reissue of PA-18-658
PA-19-165
None
93.313; 93.393; 93.394; 93.395; 93.396; 93.399; 93.867; 93.866;93.273; 93.855; 93.846; 93.286; 93.865; 93.279; 93.121; 93.847; 93.113; 93.242; 93.361; 93.879; 93.351; 93.853, 93.233, 93.837, 93.938, 93.939, 93.840, 93.173, 93.307, 93.213
The Office of Research on Women's Health (ORWH) announces the availability of administrative supplements to support research highlighting the impact of sex/gender influences in human health and illness, including basic, preclinical, clinical, translational, and behavioral studies. Of special interest are studies relevant to understanding the significance of biological sex on cells and tissue explants; comparative studies of male and female tissues, organ systems and physiological systems; sex-based comparisons of pathophysiology, biomarkers, gene expression, clinical presentation and prevention and treatment of diseases. The most robust experimental designs include consideration of both sex and gender; therefore, applications proposing to investigate the influence of both sex and gender factors are highly encouraged. The proposed research must address at least one of the five strategic goals of the new 2019-2023 Trans-NIH Strategic Plan for Women's Health Research "Advancing Science for the Health of Women".
January 17, 2019
January 20, 2019
Not Applicable
February 20, 2019, by 5:00 PM local time of applicant organization.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
Not Applicable
Not Applicable
July/August 2019
February 21, 2019
Not Applicable
It is critical that applicants follow the instructions in the Application Guide (SF424 (R&R) Application Guide, eRA Commons Administrative Supplement User Guide or PHS 398 Application Guide, as appropriate) except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The mission of the NIH is to seek fundamental knowledge about the nature and behavior of living systems, and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. The Office of Research on Women's Health (ORWH) works in partnership with the NIH institutes, centers, and offices to ensure that research on sex/gender factors in health and illness is an integral part of the scientific framework.
This Funding Opportunity Announcement (FOA) requests applications for one year of funding for the fiscal year (FY) 2019 Administrative Supplements for Research on Sex/Gender Influences. This program is designed to provide supplemental funding to NIH-funded researchers to encourage the consideration of sex/gender factors in their ongoing research. The proposed research must address at least one of the five strategic goals of the new 2019-2023 Trans-NIH Strategic Plan for the Health of Women "Advancing Science for the Health of Women".
Women and men are characterized by both sex and gender, as highlighted in the Institute of Medicine (IOM) report, "Exploring the Biological Contributions to Human Health: Does Sex Matter?" (IOM Report, 2001). For administrative supplement application, ORWH will use IOM definitions to describe sex and gender-based studies:
Sex and gender are important considerations in many areas of research, including basic biological, psychological, social, and behavioral studies. With continuous interaction between sex and gender, human health is determined by both biology and expression of gender.
Consideration of these variables and comparisons of males and females may be critical to the accurate interpretation, validation, and generalization of research findings. Sex and gender may also determine how health and disease processes differ among women, or between women and men, and inform the development and testing of preventive and therapeutic interventions in both sexes. Sex-based comparisons in research may also ensure that findings are applicable to both women and men.
In a 2014 Nature commentary, NIH leadership called attention to a lack of knowledge about the influence of biological sex in preclinical research. Overreliance on male animals and cells in basic and preclinical research may obscure key sex differences that could guide clinical studies. Inadequate specification of the sex of cells, inadequate inclusion of female animals in experiments, and inadequate analysis and reporting of data by sex, may also contribute to irreproducibility of preclinical biomedical research. Additional information can be found in the article "Studying both sexes: a guiding principle for biomedicine" published by Dr. Clayton in FASEB J, 2016.
As of January 2016, the NIH expects that sex as a biological variable (SABV) will be factored into research design, analyses, and reporting in vertebrate animals and human subjects. This new policy is part of NIH's efforts to enhance rigor and reproducibility, and transparency. In parent awards, appropriate consideration of SABV depends on the context of the research question, existing knowledge about male and female biology and behavior, and other factors.
The current ORWH Administrative Supplement FOA is designed to enhance the ability of currently funded researchers to incorporate and/or enhance the influence of sex as a primary or key research outcome. For further information on NIH's expectations about consideration of sex as a biological variable, and NIH's initiative to improve reproducibility through rigor and transparency, please see the following documents: NOT-OD-15-102, NOT-OD-15-103, NOT-OD-16-011, NOT-OD-16-012.
All applicants must demonstrate that their supplement applications specially address at least one of the five strategic goals of the new 2019-2023 Trans-NIH Strategic Plan for Women's Health Research "Advancing Science for the Health of Women":
A broad range of research fitting under these goals may be appropriate for an administrative supplement application. Of special interest would be studies to understand the influence of biological sex on cells, primary cell cultures, immortalized cell lines, transformed cells, and tissue explants. For example, the following topics would be considered of interest, but are not limited to those listed below:
Other areas of interest include the study of both male and female subjects, and the comparison of their outcomes in the following general areas:
Finally, ORWH is specifically interested in supporting studies related to the influence of gender on human health. Topics of interest include, but are not limited to:
For this administrative supplement, the following study types are considered responsive, if they are within the scope of the currently funded peer-reviewed parent applications. In order to be responsive to the FOA, each application must address at least one of the following study types:
For this administrative supplement, the following approaches are considered responsive, if they are within the scope of the currently funded peer-reviewed parent applications. In order to be responsive to the FOA, each application must address at least one of the following research approaches:
See Section VIII. Other Information for award authorities and regulations.
The funding instrument will be the same as the parent award.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
Non-competing Administrative Supplements
Optional: Accepting applications that either propose or do not propose clinical trial(s)
Need help determining whether you are doing a clinical trial?
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
The Office of Research on Women's Health (ORWH) intends to commit $3 million in FY 2019 to award 20 admin supp applications.
The Administrative Supplement application budget is limited to one year only.
Application budgets are limited to no more than the amount of the current parent award and must reflect the actual needs of the proposed project.
Application budget cannot exceed a maximum direct cost of $100,000 excluding consortium F&A costs. In addition to the direct cost, applicable F&A (indirect) cost can also be requested.
Supplements may provide support above the dollar limits of the funding opportunity announcement of the parent grant award.
The funding mechanism being used to support this program, administrative supplements, can be used to cover cost increases that are associated with achieving certain new research objectives, as long as the research objectives are within the original scope of the peer reviewed and approved project, or the cost increases are for unanticipated expenses within the original scope of the project. Any cost increases need to result from making modifications to the project that would increase or preserve the overall impact of the project consistent with its originally approved objectives and purposes.
The project and budget periods must be within the currently approved project period for the existing parent award.
The award project period is limited to one year. Also, the parent grant must have at least 16 months of active grant support remaining from the administrative supplement application due date.
Only one administrative supplement award is permitted to a peer-reviewed NIH funded grant in one grant cycle.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
All organizations administering an eligible parent award may apply for a supplement under this announcement.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
o Hispanic-serving Institutions
o Historically Black Colleges and Universities (HBCUs)
o Tribally Controlled Colleges and Universities (TCCUs)
o Alaska Native and Native Hawaiian Serving Institutions
o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Other
This announcement is for supplements to existing projects. To be eligible, the parent award must be active and the research proposed in the supplement must be accomplished within the competitive segment. The proposed supplement must be to provide for an increase in costs due to unforeseen circumstances. All additional costs must be within the scope of the peer reviewed and approved project.
IMPORTANT: The research proposed by the NIH grantee in the supplement application must be within the original scope of the NIH-supported grant project.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Since administrative supplements are made against active grants and cooperative agreements, many of these registrations may already be in place. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Individual(s) must hold an active grant or cooperative
agreement, and the research proposed in the supplement must be accomplished
within the competitive segment of the active award. Individuals are encouraged to
work with their organizations to develop applications for support.
For supplements to parent awards that include multiple PDs/PIs, the supplement
may be requested by any or all of the PDs/PIs (in accordance with the existing
leadership plan) and submitted by the awardee institution of the parent award. Do
not use this administrative supplement application to add, delete, or change
the PDs/PIs listed on the parent award. Visit the Multiple Program
Director/Principal Investigator Policy in the SF424 (R&R) Application Guide
for more information.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is sufficiently distinct from any other administrative supplement application currently under consideration by the awarding NIH Institute or Center.
In order for an administrative supplement application to be responsive to the FOA:
1. The parent peer-reviewed NIH funded grant must have at least 16 months of active grant support remaining from the administrative supplement application due date. No cost extension does not count as eligible time period.
2. Only one administrative supplement award is permitted to a peer-reviewed NIH funded grant in one grant cycle.
3. And the application must address:
Applicants must prepare applications using current forms in accordance with the Application Guide.
Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
All forms must be completed for the supplemental activities only and must not reflect funding or activities for the previously awarded parent award.
It is critical that applicants follow the instructions for their submission option (SF424 (R&R) Application Guide, eRA Commons Administrative Supplement User Guide or PHS 398 Application Guide, as appropriate) including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to documented requirements is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
All page limitations applicable to the parent award as described in the Application Guide and the Table of Page Limits must be followed.
Administrative supplement requests for most single-project activity codes can be submitted using either paper or electronic submission processes. Administrative supplement requests for multi-project activity codes must be submitted using the paper submission process. See Activity Code section in Part 1 to determine if electronic submission is an option for your activity code.
Applicants submitting paper applications must use the PHS 398 Application Forms and the PHS 398 Application Guide.
Instructions for Electronic Application Submission through Grants.gov
Use the Apply button(s) in Part I of this announcement to access the application forms package posted at Grants.gov. If presented with more than one form package, use the Competition ID and Competition Titles provided to determine the most appropriate application forms package for your situation.
Prepare applications using the SF424 (R&R) forms associated with the chosen package. Please note that some forms marked optional in the application package are required for submission of applications for this announcement. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate required and optional forms, with the following additional guidance:
Special Instructions for Streamlined Submissions using the eRA Commons for electronic-based submissions
NIH offers a streamlined system through the eRA Commons for submitting administrative supplements. Login to the eRA Commons, identify the parent award, and prepare an administrative supplement request. A User s Guide for submitting through this system is available, with the following additional guidance:
Instructions for Paper-based Submissions using the PHS 398 Application Forms
Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application, with the following additional guidance:
The grantee institution, on behalf of the PD/PI of the parent award, must submit the request for supplemental funds directly to the awarding component that supports the parent award. Submit a signed, typewritten original of the application, including the checklist, to:
Rajeev K. Agarwal, Ph.D.
Senior Research Program Officer
Office of Research on Women's Health
National Institutes of Health
6707 Democracy Boulevard, Suite 400
Bethesda, MD 20892-5484
Telephone: 301-402-1770
Email: Rajeev.Agarwal@NIH.Gov
When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).
All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.
Part I. Overview Information contains information about Key Dates and Times. Applicants are encouraged to submit electronic applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Applicants are responsible for viewing their electronic application before the due date in the eRA Commons to ensure accurate and successful submission.
For electronic application submission, information on the submission process and a definition of on-time submission are provided in the SF424(R&R) Application Guide.
For paper-based application submission, information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS 398 Application Guide.
This initiative is not subject to intergovernmental review.
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 only as described in the NIH Grants Policy Statement.
Applications must be submitted using the instructions specified above.
Applicants must complete all required registrations prior to submission. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission contact the Application Submission Contacts in Section VII.
Important
reminders:
For applications submitted electronically on the SF424
(R&R) Application forms, all PD(s)/PI(s) must include their eRA Commons ID
in the Credential field of the Senior/Key Person Profile form of the SF
424(R&R) Application Package. Failure to register in the Commons and to
include a valid PD/PI Commons ID in the credential field will prevent the successful
submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the (SAM). Additional information may be found in the Application Guide.
See more tips for avoiding common errors.
Not Applicable
Administrative Supplements do not receive peer review. Instead, the administrative criteria described below will be considered in the administrative evaluation process.
The staff of the NIH awarding component will evaluate requests for a supplement to determine its overall merit. The following general criteria will be used:
Budget and Period of Support
NIH staff will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Overall Impact
NIH staff will consider the ability of the proposed supplement activities to increase or preserve the parent award’s overall impact within the original scope of award:
In addition, each of the following criteria will be evaluated as applicable for the proposed supplement.
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, NIH staff 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 categories of research that are exempt under 45 CFR Part 46, NIH staff will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults)to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
NIH staff will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
NIH staff 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.
Administrative supplement requests will undergo an
administrative evaluation by NIH staff, but not a full peer review. Applications
submitted for this funding opportunity will be assigned to the awarding
component for the parent award and will be administratively evaluated using the
criteria shown above.
Not Applicable
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. This may be as an NoA for the supplemental activities only; alternatively, it may be as either a revision to the current year NoA or included as part of a future year NoA. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website. When calculating the award for additional funds, NIH will 1) prorate funding if the requested budget period is adjusted at the time of award, and 2) use the institution’s current F&A rate; i.e., the rate in effect when the new funding is provided.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety
Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
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. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
Cooperative Agreement Terms and Conditions of Award
Any supplements to Cooperative Agreements will be subject to the same Cooperative Agreement terms and conditions as the parent award.
Reporting requirements will be specified in the terms and conditions of award as applicable to the supplemental activities. In most non-competing continuation applications, the progress report and budget for the supplement must be included with, but clearly delineated from, the progress report and budget for the parent award. The progress report must include information about the activities supported by the supplement even if support for future years is not requested. Continuation of support for the supplement activities in the remaining years of the competitive segment of the grant will depend upon satisfactory review by the NIH awarding component of progress for both the parent award and the supplement project, the research proposed for the next budget period, and the appropriateness of the proposed budget for the proposed effort. This information is submitted with the Research Performance Progress Report (RPPR) and financial statements as required in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred
method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
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method of contact)
Telephone: 301-945-7573
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Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Merav Sabri, Ph.D.,
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-496-2583
Email: merav.sabri@nih.gov
Rajeev K. Agarwal, Ph.D.
Office of Research on Women's Health (ORWH)
Telephone: 301-402-1770
Email: Rajeev.Agarwal@NIH.Gov
Diane Palmieri, Ph.D.
National Cancer Institute (NCI)
Telephone: 301-496-0030
Email: palmierd@mail.nih.gov
Lisa A. Neuhold, Ph.D.
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: lneuhold@mail.nih.gov
Xenia Tigno, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0202
Email: xenia.tigno@nih.gov
Kate Nagy
National Institute on Aging (NIA)
Telephone: 301-496-3121
Email: nagyk@mail.nih.gov
Ivana Grakalic, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-7600
Email: igrakalic@mail.nih.gov
Juliane Caviston, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-5094
Email: Juliane.Caviston@niaid.nih.gov
Su-Yau Mao
National Institute of Arthritis and Musculoskeletal and Skin
Diseases (NIAMS)
Telephone: 301-594-5032
Email: su-yau.mao@nih.gov
Steven Zullo, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 240-271-9007
Email: Steven.Zullo@nih.gov
Candace M. Tingen, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development
(NICHD)
Telephone: 301-435-6971
Email: TingenCM@mail.nih.gov
Cora Lee Wetherington, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-1319
Email: cwetheri@nida.nih.gov
Dena Fischer, D.D.S., M.D.S., M.S.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4876
Email: dena.fischer@nih.gov
Chris Mullins, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-451-3447
Email: mullinsc@extra.niddk.nih.gov
Thaddeus T. Schug
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-9469
Email: schugt2@niehs.nih.gov
Tamara Lewis Johnson, MPH, MBA
National Institute of Mental Health (NIMH)
Telephone: 301-594-7963
Email: tamara.lewisjohnson@nih.gov
Sung Sug (Sarah) Yoon, RN, Ph.D.
National Institute of Nursing Research (NINR)
Telephone: 301-402-6959
Email: sungsug.yoon@nih.gov
Hua-Chuan Sim, M.D.
National Library of Medicine (NLM)
Telephone: 301-594-4882
Email: simh@mail.nlm.nih.gov
Sheri Hild, Ph.D.
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-594-8937
Email: hildsa@mail.nih.gov
Jim Koenig, Ph.D.
National Institute of Neurological Disorders and Stroke
(NINDS)
Telephone: 301-496-1431
Email: jim.koenig@nih.gov
Trinh T. Ly, M.D.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-496-5061
Email:trinh.ly@nih.gov
Lanay M. Mudd, Ph.D., FACSM
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-9346
Email: lanay.mudd@nih.gov
Beda Jean-Francois, Ph.D.
National Institute of Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-9764
Email: beda.jean-francois@nih.gov
Not Applicable
Shelley Carow
National Center for Complementary and Integrative Health (NCCIH)
Telephone:301-594-3788
Email: carows@mail.nih.gov
Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: wolfreyc@mail.nih.gov
Karen Robinson-Smith
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: Karen.Robinson.Smith@nei.nih.gov
Taryn Cobb
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8025
Email: taryn.cobb@nih.gov
Traci Lafferty
National Institute on Aging (NIA)
Telephone: 301-496-8987
Email: laffertt@nia.nih.gov
Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: jfox@mail.nih.gov
Donna R. Sullivan
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2979
Email: dsullivan@niaid.nih.gov
Leslie Littlejohn
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-2545
Email: littlele@mail.nih.gov
Katie Ellis
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4791
Email: kellis@mail.nih.gov
Bryan S. Clark
Eunice Kennedy Shriver National Institute of Child Health and Human Development
(NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov
Pamela Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-6710
Email: pfleming@nida.nih.gov
Diana Rutberg, M.B.A.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: rutbergd@mail.nih.gov
Tommy Gunter
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-451-3447
Email: gunterto@mail.nih.gov
Aaron Nicholas
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-7823
Email: nicholaa@niehs.nih.gov
Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: tamara.kees@nih.gov
Kelli Oster
National Institute of Nursing Research (NINR)
Telephone: 301-594-2177
Email: osterk@mail.nih.gov
Samantha Tempchin
National Library of Medicine (NLM)
Telephone: 301-496-4222
Email: samantha.tempchin@nih.gov
Gavin Wilkom
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0964
Email: wilkomg@mail.nih.gov
Tijuana Decoster, PhD
National Institute of Neurological Disorders & Stroke
(NINDS)
Telephone: 301-496-9531
Email: decostert@mail.nih.gov
Christopher Myers
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-435-0713
Email: myersc@mail.nih.gov
Shelley Carow
National Center for Complementary and Integrative Health (NCCIH)
Telephone:301-594-3788
Email: carows@mail.nih.gov
Priscilla Grant, J.D.
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: grantp@mail.nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
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 Part 75.