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

Supplements to Promote Clinical Research Studies on Pediatric Burkitt Lymphoma in Low- and Middle-Income Countries (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
  • NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015)
Funding Opportunity Announcement (FOA) Number

PA-16-086

Companion Funding Opportunity

None

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

93.397, 93.395, 93.394  

Funding Opportunity Purpose

The Center for Global Health (CGH) at the National Cancer Institute (NCI) seeks to promote clinical research studies on pediatric Burkitt Lymphoma (BL) in low- and middle-income countries (LMICs) through collaborations and research partnerships between NCI-designated Cancer Centers and partner institutions in LMICs.

Through this funding opportunity announcement (FOA), the NCI will provide administrative supplement awards to currently funded P30 NCI-designated Cancer Center grants to support pilot research projects on pediatric BL. These partnerships between NCI-designated Cancer Centers and institutions in LMICs are expected to improve diagnosis and treatment strategies to alleviate pediatric BL burden in LMICs. It is expected that the pilot research projects funded by these administrative supplements would support the clinical research needs  for treatment of BL in the region.

Key Dates
Posted Date

January 15, 2016

Open Date (Earliest Submission Date)

March 15, 2016

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

April 15, 2016

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

Not Applicable

Advisory Council Review

Not Applicable

Earliest Start Date

July 2016

Expiration Date

April 16, 2016

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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.


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

The Center for Global Health (CGH) at the National Cancer Institute (NCI) seeks to promote clinical research studies on pediatric Burkitt Lymphoma (BL) in low- and middle-income countries (LMICs). This administrative supplement funding opportunity announcement (FOA) uses the World Bank's definition of LMIC, which provides relevant definitions for low, lower-middle, and upper-middle income countries. Through this FOA, the NCI will provide administrative supplements to selected P30 grants for NCI-designated Cancer Centers. These supplements are expected to augment Cancer Center research by supporting pilot research projects on pediatric BL relevant to specific needs of the respective LMICs. These pilot projects must involve collaborations between Cancer Centers and appropriate institutions in LMICs. The collaborations will leverage the scientific expertise of the Cancer Centers and help develop diagnosis and treatment strategies to alleviate pediatric BL burden in LMICs.

Background

Infectious agents cause approximately 20% of all cancers worldwide and are responsible for adding two million new cancer cases per year. The burden of cancers caused by infectious agents is nearly three times higher in LMICs compared to developed countries. The outcomes for many of these cancers in LMICs can be improved by implementing standardized diagnosis and treatment protocols, integrated patient care, and supportive follow-up care.

Burkitt Lymphoma, a highly aggressive B cell lymphoma, was the first human cancer linked to an oncogenic virus, EBV, and to the activation of a specific cellular oncogene, c-myc. The cure rate for persons with pediatric BL is about 90 percent in developed countries and ranges from 30 percent to 50 percent in developing LMICs. This presents a unique research opportunity to improve the outcomes and survival rates for pediatric BL patients in LMICs. One strategy to improve outcomes for pediatric BL patient in LMICs is to develop new, or strengthen existing partnerships between BL researchers at NCI-designated Cancer Centers and BL researchers in LMIC institutions. These collaborative pilot research projects will improve our collective understanding of infectious etiology of cancers and significantly improve patient outcomes for pediatric BL patients living in LMICs.

General Scientific Priorities

Pilot projects supported through these administrative supplements are expected to improve diagnosis and treatment strategies to alleviate pediatric BL burden in LMICs.


Research of particular interest includes projects focused on:

1) Optimizing standard anatomy, pathology, and other methods for accurate diagnosis and staging of pediatric BL patients in LMIC settings;

2) Designing and testing rigorous, standardized chemotherapy regimens that are resource-appropriate for treating pediatric BL patients in LMIC settings; and/or

3) Developing evidence-based methods for delivering resource-appropriate supportive care for pediatric BL patients in LMIC settings.

As appropriate, the pilot projects can augment existing BL research programs in the Cancer Centers. Cancer Centers applying for these supplements are expected to leverage existing BL research capacity in the partnering LMIC institution.

All pilot project administrative supplement applications must meet the following requirements:

  • All applications must be based on an established or newly formed partnership between NCI-designated Cancer Center and clinical LMIC institution(s). 
  • The applicant institution (i.e., NCI-designated Cancer Center) must have appropriate scientific expertise to conduct pediatric BL research relevant to the needs of the LMIC communities.
  • NCI-designated Cancer Center applicants should also have a record of conducting international clinical research studies in LMICs.
  • The partnering LMIC institution is expected to have strong clinical capabilities, including the access to pediatric BL patients (and their treatment) in numbers that are commensurate with the scope and goals of the project proposed.
  • The LMIC site should also have experience in participating in clinical research projects, including understanding of regulations pertaining to human subject research, ethics for conducting clinical research, etc.

It is expected that by the end of the project phase, the participating LMIC institutions will develop clinical research capabilities to participate in multi-national clinical research projects highlighted in the research strategy section. Additionally, these collaborative pilot research projects must contribute to the collective understanding of infectious etiology of cancers and significantly improve outcomes for pediatric BL patients living in LMICs.

Note: Applicants must be able to properly document the capabilities/resources outlined above (for details, see Section IV, under "Letters of Support" and "Resources".)

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.

NCI intends to commit up to $1,000,000 in direct costs in FY 2016 to fund 5 - 10 administrative supplements.

Award Budget

The combined direct cost budget for the 2-year project period may not exceed $200,000. Application budgets are limited to no more than $100,000 in direct costs in any single year.  These caps are exclusive of consortium/contractual Facilities and Administrative (F&A) costs.

At least 60% of the proposed budget must be for costs at the LMIC institution.

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 project period of the supplement may not include any anticipated period of no-cost extension of the parent grant.

The proposed project period for Administrative Supplement must not exceed 24 months and may be shorter.

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.

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:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • 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)

Governments

  • State Governments
  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Regional Organizations

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.

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 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.
  • 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 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.

These supplements to the parent P30 Cancer Center grants must be requested by the PD/PI of the parent P30 grant, i.e., the Director of the NCI-designated Cancer Center. 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

A Cancer Center may submit more than one application provided that these applications are based on partnerships with different LMIC institutions.

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

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

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 (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, with the following exceptions or additional requirements:

The Research Strategy is limited to 3 pages.

Application Submission

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

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:

Introduction: Describe how the proposed supplemental activities relate to the parent award.

Specific Aims: Include a brief statement of expected impact and scientific relevance of the pilot research project in improving pediatric BL outcomes in LMICs. Specify the General Scientific Priority listed in the Funding Opportunity Description section of this FOA. Indicate whether this is an established or new collaboration.

Research Strategy: Describe the planned research and explain how it relates to the General Scientific Priorities defined in this Administrative Supplements Program. Explain how the proposed supplemental activities will enhance the existing BL research activities conducted under the parent award. Proposed research should be culturally and resource appropriate.

Applications should address and describe the following points:

1. How the proposed pilot project serves the pediatric BL clinical research needs of the region.

2. What the roles, responsibilities, and division of labor are among all project staff and each partner institution contribute to the success of the research project.

3. What is the feasibility of the proposed pilot project?

4. What are the anticipated short-term and mid-term outcomes of the research program?

5. How the institutional support contributes to the success of the proposed clinical research study.

6. How the NCI-designated Cancer Center will conduct an internal audit to monitor data quality and compliance to research protocols in the partnering LMICs sites.

7. What are the detailed project evaluation protocol and evaluation metrics for expected outcomes?

Timeline: Include a timeline showing the planned research milestones for the project period.

Expected Outcomes:

It is expected that upon completion of these pilot research projects, the LMIC institution will demonstrate an improvement in the pediatric BL outcomes within the LMIC communities using one or more of the criteria below:

1) Improved standard diagnostic accuracy.

2) Improved treatment outcomes by improved supportive care.

3) Reduced treatment abandonment by improving follow-up of patients.

Additionally, it is expected that by the end of the pilot project period the grantees will develop clinical research capabilities to participate in multi-national clinical research projects. These capabilities include:

1) Ability to standardize, share and implement protocols for accurate diagnosis, staging, treatment, and care of pediatric BL patients;

2) Ability to follow standard protocols to collect, process, store, and transfer biospecimens in compliance with material transfer agreements of the LMIC government;

3) Ability to collect, enter and share clinical research data in compliance with ethical and regulatory requirements of partnering LMIC sites; and

4) Ability to periodically report progress and share insights gained during the pilot project period via meetings and teleconference calls organized by CGH.

Letters of Support: Applicants must provide letters of support signed by the LMIC institution(s) clearly and specifically documenting their commitments to research funding, space allocation, faculty positions, salary for staff, protected time for research, purchase of equipment, etc. for this award period.

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):

All instructions in the Application Guide must be followed, with the following additional instructions:

  • 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.

Under Key Personnel, designate a Cancer Center investigator, who will serve as project leader and a LMIC institution investigator, who will serve as project co-leader. An additional investigator from the Cancer Center may be designated as a project co-leader.

Additionally, cancer centers may elect to include, as appropriate, consultants from other scientific organizations; for example, investigators in the NIH intramural program or at the Veterans Administration.

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.

Provide appropriate budget forms for Consortium/Contractual Arrangements with the LMIC institutions. Note that least 60% of the proposed direct costs must be for costs at the LMIC institution.

In Budget Justification, explain the division of responsibilities among all U.S. and LMIC project staff  that should reflect budgetary requests.

Allowable costs are limited to:

1: Salary support for personnel involved

(The Cancer Center Director is not required to provide effort to this supplement.)

2: Limited travel (up to $10,000/ year) for the LMIC co-leader to present the research at conferences. In the budget justification, include the destination, dates or duration of stay for all anticipated travel. It is important that the application clearly explains how the travel is directly related to the intent of this award.

3: Costs for procuring specialized materials/ resources/ reagents that cannot be accommodated by the Cancer Center shared resources.

Resources:

Describe the research environment at both the United States (U.S.) institution and the LMIC. Address specifically the requirements stated in Section I by documenting sufficient access to pediatric BL patients, ability to meet the regulatory and administrative requirements associated with clinical research projects, as well as other relevant resources.

Appendix:

All instructions in the Application Guide must be followed, with the following additional instructions for 
IACUC Documentation and IRB Documentation. If applicable, include documentation 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, preferably via e-mail in an attached pdf, to:

Vidya Vedham, Ph.D.
National Cancer Institute
Telephone: 240-276-7272
Fax: 240-276-5820
Email: NCIBLFOA@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.

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.

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.

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

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:

1) Will the administrative supplement increase or preserve the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved?

2) Will the pilot research project help identify and standardize accurate, safe, ethical, and effective diagnosis and treatment protocols for improving pediatric BL patient outcomes in LMICs?

3) Will the administrative supplement leverage the scientific expertise at NCI-designated Cancer Centers to respond to the research needs for improving pediatric BL patient outcomes in the LMIC communities?

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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

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. 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.

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
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-435-0714

Scientific/Research Contact(s)

Vidya Vedham, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7272
Email: NCIBLFOA@mail.nih.gov

Shannon L. Silkensen, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5809
Email: NCIBLFOA@mail.nih.gov

Peer Review Contact(s)

Not Applicable

Financial/Grants Management Contact(s)

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: wolfreyc@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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