Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)

Funding Opportunity Title

Fostering Research Training and Education Programs for High School and Undergraduate Students at NCI-designated Cancer Centers (Admin Supp)

Activity Code

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:

P30 Center Core Grants

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

PA-17-241

Companion Funding Opportunity

None

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.397

Funding Opportunity Purpose

The National Cancer Institute (NCI) is committed to reducing cancer related health disparities that affect all health disparity and underserved populations in the United States and to supporting research education, training and capacity building within, and near these communities.  The NCI established the Center to Reduce Cancer Health Disparities (CRCHD) to strengthen cancer research by: addressing cancer health disparities; advising on strategic priorities, program direction, and scientific policy to strengthen cancer disparities research and training; and leading NCI’s efforts to enhance scientific workforce diversity through the training of students and investigators from underrepresented backgrounds.

Through this funding opportunity announcement (FOA), the NCI proposes to award one-time 1-year administrative supplements to existing P30 Cancer Center Support Grants at NCI-designated Cancer Centers (CCs) to support the planning of cancer research training and education programs placing special emphasis on the cancer disparities afflicting AI/AN populations.  An NCI-designated Cancer Center (CC) may work with institutions that have a demonstrated interest in AI/AN education and health-research.  For example, such institutions may include, but are not limited to, Tribal Colleges and Universities (TCUs) and organizations dedicated to addressing the unique health needs of AI/AN.  By involving these institutions, a better understanding of both community health concerns and needs regarding health research may be attained.  The approach in which the community is empowered in community-based participatory research (CBPR) is beneficial in both designing research relevant to the health needs of the communities and providing sustainability of addressing these needs with culturally competent trained researchers.

Key Dates

 

Posted Date

March 30, 2017

Open Date (Earliest Submission Date)

March 30, 2017

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

April 28, 2017, by 5:00 PM local time of the applicant institution.

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.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

Not Applicable

Advisory Council Review

Not Applicable

Earliest Start Date

 June 2017

Expiration Date

 April 29, 2017  

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Application Guide (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.


Table of Contents

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


Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
 Purpose

The National Cancer Institute (NCI) is committed to reducing cancer related health disparities that affect all health disparity and underserved populations in the United States and to supporting research education, training and capacity building within, and near these communities.  The NCI established the Center to Reduce Cancer Health Disparities (CRCHD) to strengthen cancer research by: addressing cancer health disparities; advising on strategic priorities, program direction, and scientific policy to strengthen cancer disparities research and training; and leading NCI’s efforts to enhance scientific workforce diversity through the training of students and investigators from underrepresented backgrounds.

American Indians and Alaska Natives (AIs/ANs) include people having origins in any of the original peoples of North, South America, and Central America, who maintain tribal affiliation or community attachment.  As of 2012, there were an estimated 5.2 million people who were classified as American Indian and Alaska Native (AI/AN) alone or AI/AN in combination with one or more other races.  This racial group comprises 2 percent of the total U.S. population.  The AI/AN communities have long experienced health disparities compared with other Americans.  Health disparities of AIs/ANs may be related to a complex set of factors, including the paucity of health research on these populations, remote or isolated geographic locations and a lack of investigators able to navigate cultural barriers.

Twenty-two percent of AIs/ANs live on reservations or other trust lands.  Sixty percent of AIs/ANs live in metropolitan areas, which is the lowest metropolitan percentage of any racial group.  1.5 million AIs/ANs are under the age of 18, which comprises 30 percent of this racial group.  The 2010 Census reveals that 78 percent of AIs/ANs live outside of tribal statistical areas.  The AI/AN populations frequently face issues that prevent them from receiving quality medical care.  These issues include cultural barriers, geographic isolation, inadequate sewage disposal, and low income (see https://www.minorityhealth.hhs.gov/omh/browse.aspx?lvl=3&lvlid=62).  These factors may also contribute to health disparities, and low rates of participation in cancer research.

Opportunities are needed to address health disparities and educate the next generation of students who are interested in health research, and available in the future to conduct biomedical, clinical, behavioral, and health services research that is culturally competent and responsive to the needs of members of the AI/AN community.  The NCI has been a leader in cancer research training, and enhancing the participation of individuals from underrepresented and underserved backgrounds through its Continuing Umbrella of Research Experiences (CURE).  The NCI's Center for Cancer Training also provides support for the training of a diverse cadre of investigators; however, despite these efforts, the participation of AI/AN students and investigators remains consistently low.  The low representation of AIs/ANs in the biomedical, clinical, and behavioral research workforce may be due in part to the lack of programs located near AI/AN tribes and families.

Through this funding opportunity announcement (FOA), the NCI proposes to award one-time 1-year administrative supplements to existing P30 Cancer Center Support Grants at NCI-designated Cancer Centers (CCs) to support the planning of cancer research training and education programs placing special emphasis on the cancer disparities afflicting AI/AN populations.  An NCI-designated Cancer Center (CC) may work with institutions that have a demonstrated interest in AI/AN education and health-research.  For example, such institutions may include, but are not limited to, Tribal Colleges and Universities (TCUs) and organizations dedicated to addressing the unique health needs of AI/AN  By involving these institutions, a better understanding of both community health concerns and needs regarding health research may be attained.  The approach in which the community is empowered in community-based participatory research (CBPR) is beneficial in both designing research relevant to the health needs of the communities and providing sustainability of addressing these needs with culturally competent trained researchers. 

These one-time supplements will capitalize on the rich research resources and infrastructure available at CCs, and support the critical and necessary establishment of rapport with AI/AN communities.  This would be an initial step towards the long-term objective of increasing and strengthening the participation of students and trainees with a demonstrated interest in scientific research, and the cancer research enterprise in AI/AN communities.

Supplements may be requested solely for the planning of research training and educational programs that will provide research education for students located in geographical proximity to eligible CCs and AI/AN communities, particularly those most likely to conduct research aimed at addressing the cancer burden among AI/AN populations.

As part of the supplement request, information should be included about the CC’s connection and relationship to AI/AN communities as well as relationships with organizations dedicated to addressing the unique health needs of AI/AN.  Such entities may include, but are not limited to area Indian health boards, TCUs, and other organizations with a demonstrated interest in AI/AN health disparities research, and access to AI/AN communities.  To give background and rationale for the proposed planning effort within the scope of effort of the parent award, see PAR-17-095, Section IV, PHS Research Plan (Cancer Research Career Enhancement and Related Activities), Research Strategy, which includes efforts for "The inclusion of special or unusual areas of cancer research education (health disparities, global health, etc.)."

At the end of the 1-year administrative supplement offered through this FOA, it is expected that each participating CC will seek additional funding by developing and submitting an application to sustain the program.  For example, the CC could seek additional support through the following three current NCI FOAs for R25 applications or any other suitable funding mechanism:

  • Research Experiences: PAR-16-138, Cancer Research Education Grants Program to Promote Diversity - Research Experiences (R25).
  • Courses for Skills Development: PAR-16-139, Cancer Research Education Grants Program to Promote Diversity - Courses for Skills Development (R25).
  • NCI Youth Enjoy Science (YES) Research Education Program, which provides research experiences for K-12 teachers and undergraduate faculty members as well as for students: PAR-17-059, National Cancer Institute Youth Enjoy Science Research Education Program (R25).
Background

The National Institutes of Health (NIH) and the National Cancer Institute (NCI) are vested in working toward eliminating health disparities while supporting an understanding of elements that contribute to health and well-being.  Specifically, the mission of NIH is to acquire new knowledge that will lead to better health by understanding the processes underlying health and disease that in turn will help prevent, detect, diagnose, and treat disease and disability.  However, NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission.

There are many benefits that flow from a diverse NIH-supported scientific workforce, including improving the quality of the researchers, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.  For relevant information, see NOT-OD-15-053, NIH Notice of Interest in Diversity, NOT-OD-15-089, Definitions for NIH Diversity Programs and for Other Reporting Purposes.  Despite this focus, opportunities to address cancer health disparities by exposing students from underrepresented and underserved populations to cutting-edge research near AI/AN communities are limited.

It is expected that the research training and educational programs that will result from the planning activities supported by this FOA will facilitate the attainment of NIH's and NCI’s goal of increased diversity of the biomedical research workforce by providing opportunities for research training and education of the next generation of talented scientists from diverse backgrounds.

Allowable costs: Costs are limited to the planning activities for the identification, recruitment, training, and research skills development of eligible high school and undergraduate students with a demonstrated interest in cancer health disparities among AI/AN communities.  Allowable planning-related activities include travel reimbursement for non-CC staff, cost of meeting supplies, and incidentals.  Prior approval by the NCI Program Official may be required for other costs.  Payment of personnel salaries is not allowed with the supplemental funds.

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

Section II. Award Information
Funding Instrument

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.

Application Types Allowed

Non-competing Administrative Supplements

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

The NCI intends to commit $300,000 to support up to four administrative supplements in FY 2017.

Award Budget

The total cost of each award cannot exceed $75,000 (including $50,000 in direct costs). The awards are restricted as follows:

Allowable costs

Costs are limited to the planning activities for the identification, recruitment, training, and research skills development of eligible Native American (AI/AN) high school and undergraduate students.  Allowable planning related activities include travel reimbursement for non-Cancer Center staff, cost of meeting supplies, and incidentals.  Prior approval by the NCI Program Official may be required for other costs.  Payment of personnel salaries is not allowed with the supplemental funds.

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.

Award Project Period

The project and budget periods must be within the currently approved project period for the existing parent award. The maximum period of administrative supplement support that an NCI-designated Cancer Center may request for its P30 award is 1 year.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

All organizations administering an eligible parent award may apply for a supplement under this announcement.

Only the current awardees (with active awards for the next 2 years) from the NCI Cancer Center Support Grant (P30) program are eligible to apply for these supplements.

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.  In PAR-17-095, Section IV, Research Plan (Cancer Research Career Enhancement and Related Activities), it is stated that, as part of the Research Strategy, "The inclusion of special or unusual areas of cancer research education [health disparities, global health, etc.)" should be described; this part of the original scope of eligible awards is what can be supplemented in connection with this funding opportunity announcement.

Foreign Institutions

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 not allowed.

Required Registrations

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) (formerly CCR) – 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 and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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.

Eligible Individuals (Program Director/Principal Investigator)

Individual(s) must hold an active grant or cooperative agreement, and the planning activities 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.

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

Applicant organizations may submit more than one administrative supplement request/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 is allowed.

 
Section IV. Application and Submission Information
1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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 (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.

Page Limitations

All page limitations applicable to the parent award as described in the Application Guide and the Table of Page Limits must be followed.,  

Application Submission

 Applicants submitting paper applications must use the PHS 398 Application Forms and the PHS 398 Application Guide.

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:

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.

In addition to the above requirements, all applications should also include information as follows:

1. On the completed face page (with appropriate signatures) using Form Page 1 of PHS Form 398 (Rev. 3/16, include the title and grant number of the P30 parent grant on line 1 and in line 2 write “P30 Administrative Supplement.” 

2. A brief narrative overview of the planning activities, for example include how students will be identified, recruited, or how the cancer center relates to institutions where AI/AN students are educated, any formal agreements?  As part of the supplement request, information should be included about the CC’s connection and relationship to AI/AN communities as well as relationships with organizations dedicated to addressing the unique health needs of AI/AN.  These entities may include, but are not limited to area Indian health boards, TCUs, and other organizations with a demonstrated interest in AI/AN health disparities research, and access to AI/AN communities.  Discuss briefly how this supplement will contribute to the preparation of an R25 grant application or request for other funding.  Include a list of all key personnel and their role in the planning process.

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:

Emmanuel A. Taylor, Dr.P.H.
Center to Reduce Cancer Health Disparities
National Cancer Institute
9609 Medical Center Drive, Room 6W242
Rockville, MD 20850
Telephone: 240-276-6159
Email: taylorem@mail.nih.gov

3. Unique Entity Identifier and System for Award Management (SAM)

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.

4. Submission Dates and Times

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.

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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

 The awards are restricted as follows:

Allowable costs: Costs are limited to the planning activities for the identification, recruitment, training, and research skills development of eligible AI/AN high school and undergraduate students.  Allowable planning related activities include travel reimbursement for non-Cancer Center staff, cost of meeting supplies, and incidentals.  Prior approval by the NCI Program Official may be required for other costs.  Payment of personnel salaries is not allowed with the supplemental funds.

7. Other Submission Requirements and Information

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.

Post Submission Materials

Not Applicable

Section V. Application Review Information
1. Criteria

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

 The staff of the Center to Reduce Cancer Health Disparities (CRCHD) and the Office of Cancer Centers (OCC), will evaluate requests for a supplement to determine its overall merit. The following general criteria will be used:

  • Feasibility and innovation in approach of the planning process.
  • Qualifications of key personnel and their roles in the planning process.
  • The strength of Cancer Center’s relationship with organizations dedicated to addressing the unique health needs of American Indians and Alaska Natives.
  • The potential of the planned activities to lead to the development of a long-term program for educating, training, and engaging students in cancer biomedical research.

In addition, each of the following criteria will be evaluated as applicable for the proposed supplement.

Protections for Human Subjects:

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, 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 six 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.

Inclusion of Women, Minorities, and Children

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 children 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.

Vertebrate Animals

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.

Biohazards

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.

2. Review and Selection Process

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.

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information
1. Award Notices

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.

2. Administrative and National Policy Requirements

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

3. Reporting

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. At the end of the 1-year supplemental period, a final report should be submitted as part of the RPPR submitted for the P30 and should include detailed descriptions and results of the planning activities initiated during the funding period as well as strategies developed for a proposed R25 grant application. The detailed description of the planning process should include identification/ list of key personnel and their roles in the planning process. 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.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)

Telephone: 301-945-7573

Scientific/Research Contact(s)

Emmanuel A. Taylor, Dr.P.H.
 National Cancer Institute (NCI)
Telephone: 240-276-6159
Email: taylorem@mail.nih.gov

Peer Review Contact(s)

Not Applicable

Financial/Grants Management Contact(s)

Carol Perry
National Cancer Institute
Telephone: 240-276-6282
Email: perryc@mail.nih.gov

Section VIII. Other Information

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.

Authority and Regulations

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.

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