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

Background

Ethical considerations are intrinsic to the responsible conduct of biomedical research and the translation of scientific and technological advances into practice. Research into bioethical issues can provide an evidentiary basis to guide conduct, content, and/or application of the biomedical and behavioral sciences and their associated policies, which becomes of increasing importance as science and societal views continue to evolve. Ethical questions and challenges are interlinked with many of NIH s general areas of scientific priority, such as responding to public health needs (e.g., the opioid crisis, desire for precision medicine interventions) and emerging scientific opportunities (e.g., new data sharing infrastructure, innovative technologies). The investment in and the integration of bioethics-related research and policy demonstrates NIH’s commitment to safeguarding the integrity of the research that it conducts and supports, which, in turn, facilitates public participation and trust in the research enterprise. This administrative supplement funding opportunity announcement will provide an opportunity for NIH-supported researchers to support research on bioethical issues to develop an evidence base that may inform future policy directions. Applicants may propose to supplement parent awards focused on bioethics or to add a component related to bioethics to a parent award in which bioethics was not the focus.

Areas of Research Interest for the Administrative Supplement

The NIH seeks to fund research on ethical considerations related to biomedical research. The issues fall within the scope of research and policy activities of the NIH but may be beyond the focus of any one Institute or Center. Overarching areas of research interest may include but are not limited to:

• New and emerging technology development and use, such as: gene editing; organoids; artificial intelligence; machine learning; brain implants and modulation; digital health; consumer-generated data
• Clinical and non-clinical data sharing; big data and data science analytics; integration of data for research, including clinical, research, environment, social media, participant/patient provided, and other
• Precision and personalized medicine
• Personal, institutional, and research privacy and security
• Learning Healthcare System; interface of clinical research and clinical care; pragmatic trials
• Crowdsourcing, citizen science, and DIY biomedical research
• Participant driven, directed, or sponsored clinical research
• Patient/participant representation in research oversight, including appropriate return of research results and incidental findings
• Special and vulnerable population research, including pediatric, palliative care, emergency, disaster, and pandemic research
• Individual or community health, treatment, and/or research disparities; accessing and sharing benefits of research; post-study obligations
• Issues related to the inclusion of Tribal and American Indian/Alaska Native populations
• Issues related to the inclusion of populations underrepresented in research
• Current and emerging regulatory environments
• Innovative study design, conduct, management, and oversight, including methods for obtaining and documenting informed consent; virtual clinical trials
• International research including research in resource-constrained settings, transnational research, and research in low and middle income countries
• Research on stigmatized conditions
• Historical analyses of bioethics issues
• Novel approaches for enhancing bioethics infrastructure and training

In addition to overarching areas of interest, individual Institutes and Centers have indicated the following specific areas of research interest:

NCI

The National Cancer Institute (NCI) is interested in bioethics issues relevant to cancer research and care, such as issues raised in cancer clinical trials, cancer cohorts, cancer prevention studies, cancer centers, prospective biobanking, or projects using existing samples/tissues. Bioethical issues of interest include but are not limited to issues raised by new therapies/technologies; patient and participant perception and comprehension; patient, participant, and community engagement; return of results; and new methods for recruitment/retention of hard to reach participants. Additional issues may be found here: https://epi.grants.cancer.gov/bioethics-cancer-research.html.

NHGRI

The National Human Genome Research Institute (NHGRI) is interested in applications which investigate and address bioethical issues related to the use of genetics and genomics in research, clinical medicine and healthcare, and society. NHGRI supports studies into specific conditions or diseases only if the proposed work will produce knowledge that is generalizable or transferable to other genetic conditions.

NIA

The National Institute on Aging (NIA) is interested in applications that address topics relevant to its core mission. For more information, please see: https://www.nia.nih.gov/about/mission

FIC

The Fogarty International Center (FIC) is interested in research on ethical issues relevant to low- and middle-income countries, in particular, studies conducted by investigators in these countries.

NINDS

The National Institute of Neurological Disorders and Stroke (NINDS) is interested in research on bioethical and neuroethical questions relevant to its mission to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease. In addition to the general areas of interest listed above, areas of interest specific to NINDS include but are not limited to the ethical implications of: aspects of neuroscience research with human participants, such as differing stakeholder views on trial design, return of research results to participants, patient consent-related issues, or therapeutic misconception (including for rare diseases); research with brain organoids or ex vivo human brain tissue; collecting and sharing human brain data, such as de-identification, privacy, and re-use practices; the development and use of neuromodulation and neuroimaging technologies, such as device maintenance, data security, and intended and unintended uses of these technologies; predictive/diagnostic research related to brain disorders; and advances in neural recording and/or neuromodulation specifically for use in children. Additional information about the NINDS mission may be found here: http://www.ninds.nih.gov/about_ninds/mission.htm. Note that applications must consider bioethical and/or neuroethical questions and be within the general scope of the parent award. Also, NINDS will not consider applications that include basic research activities or research with vertebrate animals.

NCATS

The National Center for Advancing Translational Sciences (NCATS) is interested in research on ethical issues that cross disease domains and span the translational research spectrum. NCATS encourages collaboration between translational researchers and bioethics researchers on projects addressing ethical challenges in moving discoveries from laboratory, clinic, and community into interventions that improve health.

NIMHD

The National Institute on Minority Health and Health Disparities (NIMHD) is interested in supporting research projects on the ethical, legal, and social implications of research participation and/or health care for racial/ethnic minority or other health disparity populations. Areas of interest to NIMHD include but are not limited to studies that seek to understand or address cultural preferences; values and norms to ensure ethical and equitable conduct of research and delivery of health care; ethical integration of social and biomedical sciences (e.g., social epigenomics and incorporation of social determinants into the health care system); and mitigating stigmatization, group harms, and unintended social implications of research.

NICHD

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is interested in bioethical issues relevant to research involving children, pregnant women, and people with disabilities. Research in the fields of developmental biology, reproductive health, pediatrics, population health, and medical rehabilitation, research that addresses health disparities and improves prevention efforts among the populations served by NICHD, as well as areas identified as high-priority research areas to the institute are of particular interest. See and https://www.nichd.nih.gov/grants-contracts/research-areas/priorities for the current research priorities for the institute and in https://www.nichd.nih.gov/about/org/strategicplan regarding future themes for the Institute.

NHLBI

The National Heart, Lung, and Blood Institute (NHLBI) is interested in research on bioethics issues relevant to its Strategic Vision (https://www.nhlbi.nih.gov/about/strategic-vision), and its focus on heart, lung, blood, and sleep conditions. Specific examples include, but are not limited to:

• The return of research results (e.g., genomic, omic, environmental) to participants and communities, such as environmental toxins that may impact community health, the handoff between research and clinical care, and providing genetic counseling at large scales
• Waivers of informed consent or obtaining consent from surrogates
• Ethics of cardiopulmonary support
• Novel and emerging technologies, such as machine learning bias or algorithm overreach and physician autonomy
• Privacy and confidentiality (especially in large datasets), such as artificial intelligence applied to imaging data or concerns that may arise from multi-omics profiles
• The impact of NIH policy changes, such as updates to the management of genomic summary results
• Issues related to working with understudied or vulnerable populations (e.g., pregnant women, pediatric or perinatal patients, Indigenous groups), such as community engagement or ensuring equal access to research advances

Investigators are encouraged to contact NHLBI staff to discuss their ideas.

Investigators interested in developing applications for this funding opportunity announcement are strongly encouraged to discuss their ideas with specific IC contacts listed below prior to submission as ICs have varying levels of interest in high priority areas.

NIAAA

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is interested in bioethics applications that address topics relevant to its mission and research priorities as provided in its strategic plan. For information, please see: https://www.niaaa.nih.gov/strategic-plan

NIAMS

The mission of The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases; the training of basic and clinical scientists to carry out this research; and the dissemination of information on research progress in these diseases. NIAMS also conducts and supports basic research on the normal structure and function of bones, joints, muscles, and skin. Basic research involves a wide variety of scientific disciplines, including immunology, genetics, molecular biology, structural biology, biochemistry, physiology, virology, and pharmacology. Clinical research areas include rheumatology, orthopedics, dermatology, metabolic bone diseases, heritable disorders of bone and cartilage, inherited and inflammatory muscle diseases, and sports and rehabilitation medicine. NIAMS is interested in bioethics topics relevant to its core mission.

NIBIB

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) is interested in applications that address topics relevant to its core mission. For more information, please see: https://www.nibib.nih.gov/research-funding.

NIDCD

The National Institute on Deafness and Other Communications Disorders (NIDCD) is interested in applications that address topics in the areas of hearing, balance, taste, smell, voice, speech, and language. For more information, please see: NIDCD Strategic Plan.

NIDCR

The National Institute of Dental and Craniofacial Research (NIDCR) is interested in applications that propose bioethics research relevant to dental, oral, and craniofacial health. For more information, please see: https://www.nidcr.nih.gov/about-us/mission.

NIDDK

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is interested in applications that address topics relevant to its core mission. For more information, please see: NIDDK Research Areas.

NIMH

Priority areas for research include but are not limited to bioethical considerations around privacy issues; consent capacity, agency, and autonomy; use of predictive analytics; safety monitoring; participant, provider, and community perceptions and comprehension of research; issues related to the engagement and recruitment of understudied groups; and additional safety and ethical considerations necessary for conducting research in populations at risk for suicide (https://www.nimh.nih.gov/funding/clinical-research/conducting-research-with-participants-at-elevated-risk-for-suicide-considerations-for-researchers.shtml). In addition, the bioethics of new interventions and technologies, biobanking approaches, and use of biospecimens and biopreparations are of interest.

NINR

NINR is interested in studies examining the bioethical issues related to end of life and palliative care (EOLPC) research that consider (including but not limited to):

• The EOLPC needs of individuals with serious, advanced illness, particularly in vulnerable populations such as: children, frail elderly, and individuals with limited decision-making capacity.
• Prioritization of patient preferences, beliefs, and values with respect to treatment and/or end of life decision making.
• The needs/challenges of families, caregivers, and proxy decision makers of individuals with serious, advanced illness.
• Disparities in access to EOLPC for individuals across settings (urban, rural, remote), including differences among socioeconomic, racial/ethnic and geographic sub-populations.

Because of the complex, multi-factorial nature of this issue, multi-disciplinary teams are highly encouraged.

NIAID

NIAID is particularly interested in supporting supplemental projects that focus on ethical issues relevant to domestic and international collaborative research on HIV/AIDS or its co-morbidities (TB, malaria, hepatitis, sexually transmitted infections), and other infectious diseases; ethics of clinical trials and implementation science; other ethical issues relevant to NIAID's scientific mission. Applications may include conceptual work in bioethics, or empirical work gathering and analyzing data relevant to ethical issues in research, or a combination of the two. For empirical projects, data collection may include quantitative or qualitative methods, or both. Although not intended to be an exhaustive list, of particular interest are projects on:

• Ethical issues in research involving adolescents and young adults
• Ethical issues in research on curing HIV
• Ethical, legal and policy issues in research with big data
• Ethics of research involving child-bearing age and pregnant women

Applications addressing empirical research on informed consent are not of interest.

Common Fund

Office of Strategic Coordination (Common Fund) -supported projects that propose to include relevant investigations of Research on Bioethical Issues are eligible to apply.

See Section VIII. Other Information for award authorities and regulations.

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

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

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 eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are 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.

Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration. Grants.gov registration is only required if you plan to submit using the 'Electronic Application Submission through Grants.gov' option.

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 is sufficiently distinct from any other administrative supplement currently under consideration by the awarding NIH Institute or Center. Only one application per parent award may be submitted.

Applicants must prepare applications using current forms in accordance with the Application Guide.

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace 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) 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.

All page limitations applicable to the parent award as described in the Application Guide and the Table of Page Limits for the activity code of the parent award must be followed, with the following exceptions or additional requirements:

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:

• R&R Cover form: Select Revision in the Type of Application field.
• Research Plan form: At a minimum, the Research Strategy section should be completed and must include a summary or abstract of the funded parent award or project. Other sections should also be included if they are being changed by the proposed supplement activities.
• Project/Performance Site Location form: Include the primary site where the proposed supplement activities will be performed. If a portion of the proposed supplement activities will be performed at any other site(s), identify the locations in the fields provided.
• Sr/Key Personnel form: List the PD/PI as the first person (regardless of their role on the supplement activities). List any other Senior/Key Personnel who are being added through this supplement, or for whom additional funds are being requested through this supplement; include a biographical sketch for each.
• Budget forms (e.g., R&R Budget, PHS 398 Training Budget): Only include funds requested for the additional supplement activities.
• R&R Other Project Information form: If applicable, attach PDF documents in the Other Attachments field indicating that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Name the documents IACUC Documentation.pdf and/or IRB Documentation.pdf . Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects involvement is planned for the supplement.

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:

• Budget information should be entered for the grantee institution in the tabs provided for each selected budget period.
• Since there is no template or form available for subaward budget information, all subaward information must be included as a PDF attachment in the Subrecipient Budgets section showing the funds requested (by budget period) and using the same categories provided for the grantee institution. The attachment must also include any related budget justification information.
• Use the Add Other Attachments function to include the following PDF documents:
• Research Strategy including a summary or abstract of the funded parent award or project.
• If applicable, attach documents indicating that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects involvement is planned for the supplement component.

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:

• Checklist: Select Revision in the Type of Application field.
• Face Page (Form Page 1): On the face page of the application form, note that your application is in response to a specific program announcement, and enter the title and number of this announcement.
• Research Plan: At a minimum, the Research Strategy section should be completed and must include a summary or abstract of the funded parent award or project. Other sections should also be included if they are being changed by the proposed supplement activities.
• Project/Performance Sites section (Form Page 2): Include the primary site where the proposed supplement activities will be performed. If a portion of the proposed supplement activities will be performed at any other site(s), identify the locations in the fields provided.
• Sr/Key Personnel section (Form Page 2): List the PD/PI as the first person (regardless of their role on the supplement activities). List any other Senior/Key Personnel who are being added through this supplement, or for whom additional funds are being requested through this supplement; include a biographical sketch for each.
• Budget for Entire Proposed Project Period (Form Page 5): A proposed budget should be submitted using the PHS 398 budget forms and should only include funds requested for the additional supplement activities.
• If applicable, attach documentation in the Appendix section indicating that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects involvement is planned for the supplement component.

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:

Jennifer Plank-Bazinet, Ph.D.
Lead Scientific Policy Analyst
Office of Science Policy
National Institutes of Health
6705 Rockledge Blvd., Suite 750
Bethesda, MD 20892
Telephone: 301-435-8342
Email: jennifer.bazinet@nih.gov

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the Application Guide.

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 How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. 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.

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:

• Will the administrative supplement increase or preserve the likelihood for the project to exert an influence on the bioethics-related policy of the research field(s) involved?
• Will the administrative supplement add value to our understanding of bioethics?
• Does the administrative supplement address a bioethical issue that is pressing, recurring, and/or emerging in biomedical research?
• Are the overall strategy, methodology, and analyses proposed in the supplement application well-reasoned and appropriate to accomplish the proposed research in a one-year period?

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.

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.

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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.htmll 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 submission by the due date, 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)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Jennifer Plank-Bazinet, Ph.D.
Office of Science Policy/Office of the Director (OSP/OD)
Telephone: 301-435-8342
Email: jennifer.bazinet@nih.gov

Nicole Lockhart
National Human Genome Research Institute (NHGRI)
Telephone: 301-480-2493
Email: lockhani@mail.nih.gov

Tammara Jenkins, MSN, RN, PCNS-BC
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6837
Email: tjenkins@mail.nih.gov

Mollie Minear, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0448
Email: mollie.minear@nih.gov

Aynur Unalp-Arida, MD, MSc, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8879
Email: aynur.unalp-arida@nih.gov

Khara Ramos, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-594-2614
Email: khara.ramos@nih.gov

Barbara Sina, Ph.D.
Fogarty International Center (FIC)
Telephone: 301-402-9467
Email: sinab@mail.nih.gov

Elaine Collier, M.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0794
Email: colliere@mail.nih.gov

Emilie Caga-Anan, J.D.
National Cancer Institute (NCI)
Telephone: 240-276-6738
Email: charlisse.caga-anan@nih.gov

Kristina McLinden, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-827-2563
Email: kristina.mclinden@nih.gov

Pamela Wernett, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-827-5391
Email: wernettpj@mail.nih.gov

Robyn Bent, M.S.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-827-2272
Email: robyn.bent@nih.gov

Todd Merchak
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-496-8592
Email: merchakt@mail.nih.gov

Trinh Ly, M.D.
National Institute of Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-496-5061
Email: trinh.ly@nih.gov

Leslie Frieden, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-496-4263
Email: leslie.frieden@nih.gov

Andrea Beckel-Mitchener, Ph.D
National Institute of Mental Health (NIMH)
Telephone: 301-443-2847
Email: amitchen@mail.nih.gov

Nancy Jones, Ph.D., M.A.
National Institute on Minority and Health Disparities (NIMHD)
Telephone: 301-594-8945
Email: jonesna@nimhd.nih.gov

Lynn Adams, Ph.D.
National Institute of Nursing Research (NINR)
Telephone: 301-594-8911
Email: adamsls@mail.nih.gov

Leslie K. Derr, Ph.D.
Office of Strategic Coordination (Common Fund)
Telephone: 301-594-8174
Email: derrl@mail.nih.gov

Joana Roe
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3213
Email: Joana.Roe@nih.gov

Not Applicable

Bryan Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov

Eunica Haynes

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Telephone: 301-827-4018

Email: Haynese@niddk.nih.gov

Tawana McKeither
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-9238
Email: tawana.mckeither@nih.gov

Tijuana Decoster, Ph.D.
National Institute Neurological Disorders Stroke (NINDS)
Telephone 301-496-9531
Email: decostert@mail.nih.gov

Monique Day, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4797
Email: Monique.day@nih.gov

Bruce Butrum
Fogarty International Center (FIC)
Telephone: 301-496-2075
Email: butrumb@mail.nih.gov

Harvey Kincaid
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0850
Email: harvey.kincaid@nih.gov

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: wolfreyc@gab.nci.nih.gov

Deanna Ingersoll
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-7858
Email: Deanna.Ingersoll@nih.gov

Traci Lafferty
National Institute on Aging (NIA)
Phone: 301-496-8987
Email: laffertt@mail.nih.gov

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: jfox@mail.nih.gov

Leslie Littlejohn
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-5055
Email: Leslie.Littlejohn@nih.gov

Christopher Myers
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-435-0713
Email: myersc@mail.nih.gov

Diana Rutberg, M.B.A.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: rutbergd@mail.nih.gov

Terri Jarosik
National Institute of Mental Health (NIMH)
Telephone: 301-443-3858
Email: theresa.jarosik@nih.gov

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: pg38h@nih.gov

Ronald Wertz
National Institute of Nursing Research (NINR)
Telephone: (301) 594-2807
Email: wertzr@mail.nih.gov

Chris Darby
Office of Strategic Coordination (Common Fund)
Telephone: 301-480-1059
Email: DarbyCh@mail.nih.gov

Dhana Khurana
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2966
Email: Vandhana.Khurana@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.