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

NCI Community Oncology Research Program (NCORP) Research Bases (UG1 Clinical Trial Required)

Activity Code

UG1 Clinical Research Cooperative Agreements - Single Project

Announcement Type

Reissue of RFA-CA-13-012

Related Notices
Funding Opportunity Announcement (FOA) Number

RFA-CA-18-015

Companion Funding Opportunity

RFA-CA-18-016 , UG1 Clinical Research Cooperative Agreements - Single Project

RFA-CA-18-017 , UG1 Clinical Research Cooperative Agreements - Single Project 

Number of Applications

Each applicant organization may submit only one application as defined in Section III. 3. Additional Information on Eligibility.

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

93.393, 93.394, 93.395, 93.399

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) solicits applications from institutions/organizations to participate as "Research Bases" for the National Cancer Institute (NCI)-supported Community Oncology Research Program (NCORP). NCORP is a community-based research network that:

  • Designs and conducts clinical trials and other human subject studies for adults and children in cancer prevention, control, screening, and care delivery, as well as quality-of-life studies embedded within treatment trials;
  • Incorporates unique research needs of diverse populations such as, adolescents and young adults (AYAs), and the elderly; racial and ethnic minorities; sexual and gender minorities; and rural residents into studies and takes steps to enhance participation of these groups;
  • Enhances patient and provider access to treatment and imaging trials conducted under the National Clinical Trials Network (NCTN);
  • Integrates cancer disparities research within the community network.

NCORP consists of three components each with its own FOA:  NCORP Research Bases (covered by this FOA); NCORP Community Sites; and NCORP Minority/Underserved Community Sites.

The NCORP Research Bases will design and conduct cancer clinical trials and care delivery research studies as well as manage and analyze the data and report the research results.

Key Dates
Posted Date

June 13, 2018

Open Date (Earliest Submission Date)

July 31, 2018

Letter of Intent Due Date(s)

 July 31, 2018

Application Due Date(s)

August 31, 2018, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date. 

No late applications will be accepted for this FOA.

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

February - March 2019

Advisory Council Review

May 2019

Earliest Start Date

August 2019

Expiration Date

September 1, 2018  

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, 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

This Funding Opportunity Announcement (FOA) is one of three FOAs for the National Cancer Institute (NCI) Community Oncology Research Program (NCORP).  NCORP is designed to take advantage of large and diverse patient populations receiving care in a variety of community oncology settings. The purpose of this Program is to engage these cancer patient populations in rigorous studies focused on cancer control, prevention, and care delivery.

NCORP will support the following components that will be individually awarded through the respective FOAs indicated below:

  • NCORP Research Bases (this FOA)
  • NCORP Community Sites (see RFA-CA-18-016); and
  • NCORP Minority/Underserved Community Sites (see RFA-CA-18-017)

NCORP Research Bases will serve as research hubs for the NCORP network.  Research Bases are expected to:

  • Provide an established organizational structure, with scientific and statistical leadership for developing, implementing, and analyzing multi-institutional cancer control, prevention, and care delivery (CCP&CD) clinical research, as well as quality-of-life studies embedded within treatment and imaging studies.
  • Assume responsibility for study operations and data management, including efficient protocol development, compliance with Food and Drug Administration (FDA) and Office of Human Research Protections (OHRP) regulatory and participant protection requirements, audits, training, quality assurance, and support to Community Sites and Minority/Underserved Community Sites. 
  • Conduct their research activities at an institution with comprehensive expertise in cancer clinical research, such as a cancer foundation, healthcare research organization (including NCI's National Clinical Trials Network Group Operations Centers), or NCI-designated Cancer Center.
  • Integrate health disparities across all focus areas as appropriate.

NCORP Community Sites are a consortia of community hospitals and/or oncology practices, which may or may not be formally affiliated in a healthcare system, that accrues participants to cancer control, prevention, treatment and care delivery clinical trials and other human subjects research.

NCORP Minority/Underserved Community Sites are a consortia of community hospitals and/or oncology practices, a public hospital, or academic medical center that has a patient population comprising at least 30% racial/ethnic minorities or rural residents and accrues participants to cancer control, prevention, treatment and care delivery clinical trials and other human subjects research.

Key Definitions for the context of this FOA:

The terms “Clinical Research” and “Clinical Trials” in this FOA follow the NIH definitions (https://grants.nih.gov/policy/clinical-trials/glossary-ct.htm#ClinicalResearch)

NCI Central Institutional Review Board (Central IRB, https://www.ncicirb.org/about-cirb/):  is a centralized approach to human subject protection through a process that streamlines local IRB review of selected NCI-sponsored trials for institutions across the country by relying on national experts to ensure trials are reviewed efficiently and with the highest ethical and quality standards.

Community Site Primary Affiliate:  In the context of the NCORP community-based structure, a "primary affiliate" refers to a hospital, cancer center, physician practice, or other institution where patients/participants are enrolled on a regular and ongoing basis to the menu of NCI-approved clinical trials available to the NCORP Community Site or Minority/Underserved Community Site.

Community Site Sub-Affiliate:  In the context of NCORP community-based structure, a "sub-affiliate" refers to a practice or organization that contributes to the overall accrual of a primary affiliate site but is located in a separate geographic location(s), is part of the primary affiliate’s business entity, is managed by the primary affiliate, and is under the primary affiliate site’s Federal Wide Assurance (FWA).

Research Base Member Sites: Members sites affiliated with a given Research Base may include NCORP Community and Minority Underserved Community Sites, Main members, affiliates, and Lead Academic Participating sites.

Background

Whereas various academic medical centers play a crucial role in cancer clinical research, the bulk of cancer care takes place in community settings.  Expanding clinical research into community settings allows access to a larger and more diverse patient population treated in a variety of healthcare delivery settings, which can accelerate accrual to cancer clinical trials and increase the generalizability and relevance of study findings.  In addition, research in community settings reflects the complexity of cancer care delivery and engages community oncologists in efforts to develop care delivery approaches that can be implemented within usual clinical workflow.

The NCI has supported cancer clinical research within community settings for over three decades.   The participation of community oncologists, non-oncology specialists, and primary care physicians in cancer clinical trials has facilitated the introduction of research advances into practices throughout the country.  The era of genomics and molecularly-targeted therapy necessitates shifts in the delivery of cancer-related care.

The foundation of the NCORP network is the conduct of multi-site cancer clinical trials in primary focus areas of cancer control, prevention and care delivery.  In addition, NCORP plays an important role in the National Clinical Trials Network (NCTN), a major NCI-supported infrastructure for cancer clinical trials. Approximately 30 -35% of the patients enrolled on NCTN treatment clinical trials, including precision medicine studies, are from NCORP sites.

The NCORP Community Sites and Minority/Underserved Community Sites have responded to many of the challenges associated with implementation of precision medicine by providing quality specimens for genomic sequencing and establishing the multidisciplinary teams to support the new generation of clinical research. Recent advances in technology are providing new opportunities to characterize premalignancies in ways that will enhance the development of cancer prevention interventions, and biomarkers of response to those interventions, and biomarkers of risk.  NCORP’s access to diverse populations in terms of age, race/ethnicity, as well as partnerships with non-oncology practices provides a natural laboratory for the efficient development of strategies for precision prevention and a robust assessment of the risks and benefits tested. Similarly, knowledge of the role of the immune response is increasingly incorporated in cancer prevention research.  Cancer screening research is being developed and conducted in the community setting to reduce aggressive cancer incidence, identify over-diagnosis, and determine risk-based screening in the general population.  Community research organizations have proven to be well positioned to promote the science in symptom management, cancer prevention, and post-treatment surveillance. 

NCORP has streamlined its scientific and operational processes and expanded its review structure with three NCI Coordinating Center for Clinical Trials (CCCT) dedicated scientific Steering Committees, (Symptom Management & Quality of Life, Cancer Care Delivery, and Cancer Prevention) that provide peer-review for scientific concepts. Access to the Clinical Trials Support Unit (CTSU) allows sites access to all current study materials and the Central Investigational Review Board (CIRB) provides human subjects review, all of which increase efficiency and reduce redundancy.  In addition, an infrastructure for cancer care delivery research studies has been built in which both interventional and observational care delivery research studies are being conducted.

Overall Goals of NCORP and Scope of this FOA

The overall goal of NCORP is to bring cancer clinical research studies to individuals in their own communities, thereby generating a broadly applicable evidence base that contributes to improved patient outcomes and a reduction in cancer disparities.  

The roles of NCORP Community Sites and Minority/Underserved Community Sites are to provide access to a diverse patient population from varied delivery settings, allowing enhanced accrual of underrepresented populations such as racial/ethnic minorities, adolescent and young adult (AYA) and elderly, sexual and gender minorities, and rural residents to clinical trials and other human subject studies.

The role of NCORP Research Bases is to serve as a main research infrastructure for NCORP Community Sites and Minority/Underserved Community Sites.  Therefore, Research Base awardees will be expected to contribute to and focus on the following activities:

  • Interacting with NCORP Community Sites and Minority Underserved Community Sites in the development and conduct of cancer control, prevention, and care delivery clinical trials and other human subject studies.
  • Developing studies and aims that seek to identify and address determinants of cancer disparities in the context of clinical studies, including efforts to enhance research participation in underserved populations
  • Providing oversight of the conduct of clinical trials in NCORP Community Sites and Minority/Underserved Community Sites, including the responsibility for data management, reporting, and required regulatory compliance.
  • Integrating into the cancer research agenda, the expertise of primary healthcare providers, other non-oncology specialists, researchers focused on disparities, health services and behavioral studies, and patient advocates.
  • Accelerating the translation of knowledge gained from cancer research into clinical practice in diverse healthcare settings.
  • Using NCORP biospecimen banks as a scientific resource to inform future research directions.

Scope of Activities for Research Bases

The scope of research activities for the proposed NCORP Research Bases encompasses three major areas delineated below:

Area 1: Cancer Control Research; and/or

Area 2: Cancer Prevention Research; and

Area 3: Cancer Care Delivery Research.

Research Bases must cover either Area 1, or Area 2, or both. All Research Bases must cover Area 3.  

If the proposed Research Base chooses to conduct research in both Cancer Prevention (Area 1) and Cancer Control (Area 2), concept development should be reasonably balanced between the two areas.

Additional details and examples of research appropriate for Areas 1-3 are provided below.

Area 1: Cancer Control Research. Efforts in this area should be aimed to reduce the morbidities associated with cancer and its treatment, as well as improving the quality of life of individuals undergoing cancer treatment or with a history of cancer.  Studies can include, but are not limited to:

  • Elucidating the mechanisms of cancer symptoms and treatment-related toxicities.
  • Testing molecularly targeted agents to reduce toxicities.
  • Conducting observational or longitudinal studies to understand the natural history of cancer symptoms.
  • Identifying and testing biomarkers to identify predictors of risks and response to interventions in symptom management.
  • Testing interventions to improve the quality of life of patients with advanced disease and at the end of life.

Area 2: Cancer Prevention Research. Efforts in this area should be aimed at reducing cancer risk, incidence and mortality. Studies can include but are not limited to:

  • Testing chemopreventive agents.
  • Modifying lifestyle behaviors.
  • Testing new screening technologies.
  • Identifying and testing biomarkers to identify predictors of cancer risk.
  • Examining optimal time periods for detecting tumor response and recurrence during and following curative treatment (surveillance).
  • Testing different methods of diagnosis to better understand under- and over-diagnosis
  • Examining different approaches to managing precancerous lesions.

Area 3: Cancer Care Delivery Research. Efforts in this area should seek to improve clinical outcomes and patient well-being by intervening on patient, clinician, and organizational factors that influence care delivery with an emphasis on diagnosis, treatment, survivorship, and end-of-life care.   The most desirable studies will be those that undertake one or more of the following:

  • Identify modifiable factors, particularly at the clinician and organization level, that can be the target of interventions to improve care delivery.
  • Conduct pragmatic trials to assess the efficacy of interventions aimed at improving evidence-based clinical practice.
  • Test the effectiveness in community settings of interventions shown to be efficacious in academic settings.
  • Assess facilitators of and barriers to implementation and de-implementation of effective interventions in community settings.

Integrating Health Disparities Research. Research seeking to understand and address health disparities should be incorporated into each of the areas referenced above, including both studies focused exclusively on disparities and the inclusion of disparities-related aims in studies with a broad focus.  Populations of specific interest include AYA and the elderly; racial and ethnic minorities; sexual and gender minorities; and rural residents.

NCORP Trans-network Interactions

All NCORP participants will be expected to work jointly towards the NCORP network goals by using the following general strategies:

  • A coordinated and collaborative process involving broad representation from the oncology community, including academic and community clinical investigators responsible for generating cancer clinical research concepts.
  • Incorporation of innovative science into cancer clinical research through collaboration with institutions and investigators conducting research relevant to cancer control, prevention, and care delivery.
  • Evaluation of research concepts for scientific merit by nationally-recognized experts serving on NCI-managed Steering Committees.
  • Efficient and timely activation, conduct, and completion of studies, through the effective integration of scientific expertise with operational management capabilities.

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

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed

New

Renewal (but only for the awards supported under RFA-CA-13-012)

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Clinical Trial?

Required - Only accepting applications that propose clinical trial(s)

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The National Cancer Institute intends to commit $74.5 million in FY 2019 for up to seven awards. 

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project.

Award Project Period

  All applicants should request a 6-year project period.

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

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

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)

For-Profit Organizations

  • For-Profit Organizations (Other than Small Businesses)

Governments

  • State 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

  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations

The following additional provisos apply:

  • New Applications: An application must be submitted by an NCI Clinical Trials Network (NCTN) Group, cancer foundation, NCI-designated Cancer Center, or healthcare research organization with comprehensive expertise in cancer clinical research.
  • Renewal Applications: NCORP Research Base awardees seeking renewal of their current awards may submit renewal applications regardless of whether the applicant institutions have maintained their NCI-designated Cancer Center status or NCTN Group status.
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. 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.

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)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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

Only one application per institution is allowed in response to this FOA .The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).
Section IV. Application and Submission Information
1. Requesting an Application Package

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

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide 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.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Worta McCaskill-Stevens, M.D.
Telephone: 240-276-7050
Fax: 240-276-7847
Email: mccaskiw@mail.nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed with the following exception:

  • Research Strategy Section is limited to 30 pages
Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Facilities & Other Resources:  In addition to standard items for this attachment, the applicants should provide the following information/documentation.

Summary of Collective Bodies/Committees for Research Base Core Functions (use filename: Core Functions).

Provide information on committee memberships held by key investigators that will contribute to the core functions of the proposed Research Base.  Memberships may include committees such as Executive and Oversight Committees (all members should be listed); Data Safety and Monitoring Board (all members should be listed); Scientific Committees (list only Chair and Vice-Chair positions - do not include subcommittee heads); Community investigators for each Scientific Committee should be listed; and Administrative Committees (list only Chair and Vice-Chair positions - do not include subcommittee heads). Please Note: A table can be used to show this information with column headings for the Staffing Category for the Research Base (i.e., type of committee), Member status (i.e., Chair, Vice-Chair, Member) general category of Research Base or Network Group/NCI Steering Committee/NCI Initiative, specific category or activity; Member Name, Member Title, Member Institution, and Length of Service in the Position.  The date the table was prepared should be provided as a sub-heading (e.g., Information Current as of MM, DD, YY).

Constitution and By-Laws for Site & Investigator Membership in the proposed Research Base (use filename: Membership Constitution By-Laws).

Provide a summary of the Constitution & By-Laws for the proposed Research Base related to both site and investigator membership to illustrate how both sites and investigators are recruited and evaluated.

Other Attachments:  Applicants must provide the following additional material specified below.  Each attachment should be uploaded as a separate PDF using the indicated filenames (which will serve as application bookmarks).

Attachment 1.  Summary of Important Primary Scientific Achievements (use filename: Primary Achievements)

  • For Renewal applications: In this attachment, document important primary scientific achievements of the Research Base that were accomplished during the current funding period. "Important primary scientific achievements" refer to the Primary Endpoint(s) for an NCORP clinical study (or legacy NCORP study from the prior NCI-sponsored Community Clinical Oncology Program Program) specified in the protocol document.  A table can be used to show this information with column headings for the study category, i.e., CCP&CD, study design (i.e., clinical trial phase, longitudinal/cohort), year of publication of study primary outcome or other significant impact, NCORP Research Base or Network Group protocol number and brief title, experimental agent/regimen, primary endpoint result/indication, manuscript or abstract reference, brief description of the importance of the primary scientific achievement (incorporated into practice guideline), date trial activated, date trial closed to accrual, total number of patients enrolled on the trial. The timeframe for the table should be provided as a sub-heading (provide the date range encompassed).
  • For New applications: In this attachment document "important primary scientific achievements" in terms of clinical studies designed and conducted by the applicant group over the past 5 years.  Include details and formats analogous to those requested above for Renewal applications.

Attachment 2:  Summary of Other Important Achievements (use filename: Other Achievements).

  • Renewal applications:  Provide information on other important achievements associated with studies that were reported out for the last five (5) years.  Other important achievements refer to important information from secondary endpoints of NCORP clinical studies (or legacy NCORP clinical studies from the prior NCI-sponsored Community Clinical Oncology Program) specified in the protocol such as validation of an integrated biomarker or other important analyses (e.g., meta-analyses; special population analyses).  If applicable, Health Related Quality of Life (HRQOL) sub-studies in NCTN trials funded by DCP NCORP Research Base grants should be included in this table.  A table can be used to show the information such as the general cancer site category (i.e. CCP&CD), trial phase, year of publication of study primary outcome or other significant impact,  Research Base or Network Group Protocol number and brief title, experimental agent/regimen, description of secondary endpoint or sub-study result, manuscript or abstract reference, brief description of the importance of the secondary endpoint or sub-study result, date trial activated, date trial closed to accrual, and total accrual (i.e., total number of patients enrolled on the trial). The timeframe for the table should be provided (provide the date range encompassed).
  • New Applicants:  Provide information on other important achievements on clinical studies designed and conducted by the applicant group over the past 5 years.  Provide details as requested above for Renewal applications in terms of the information to include in a table format.

Attachment 3:  Summary Accrual for All Clinical Trials and Related Studies by CCP&CD Category by Members of the Research Base (use filename:  Member Accruals).

  • For Renewal applications:  Provide documentation of patient accrual on NCORP clinical studies during the current funding period by members of the Research Base. Accrual figures should include the unique number of patients enrolled on each NCORP study. Separate accrual numbers should be reported for quality of life accruals.  Include the following information: major CPC&CD categories (cancer control, prevention, care delivery) all clinical trial phases, as well as longitudinal/cohort/descriptive studies and total column summing accrual across study designs. The table should have three rows with the first row representing the number of patients enrolled by Research Base members on studies Lead by the Research Base, the second row representing the number of patients enrolled by Research Base members on studies led by other Research Bases, and the third row being the total of rows #1 and #2. The timeframe for the period of accrual should be provided as a sub-heading for each table.
  • For New applications:  Provide documentation of patient accrual to clinical studies designed and conducted by the applicant group over the past 5 years. Accrual figures should include the unique number of patients enrolled on each study.   Using preferably tabular format, summarize this information for major CPC&CD categories (cancer control, prevention, care delivery), all clinical trial phases, as well as longitudinal/cohort/descriptive studies.  Include appropriate total values reflecting summing accrual across study designs.

Attachment 4:  Conflict of Interest Policy (use filename: COI).

Provide documentation of the Conflict of Interest Policy used by the proposed Research Base to ensure that staff and investigators working on the design, monitoring, and analysis of specific studies do not have any conflicts of interest with respect to the studies. Include policies to maintain study blinding.

Attachment 5:  Model Statistical Analysis Template (use filename: Statistical Template).

Provide documentation/example of the proposed Research Base’s standard template used for generating statistical analysis plans for clinical studies as well as the proposed Research Base’s standard "Report of Studies" template for providing information related to ongoing and recently closed studies to its members.

Attachment 6Audit Policy and On-Site Auditing Summary (use filename:  Audit Policy and Auditing Summary).

  • For Renewal applications:  Provide documentation of the auditing policy for the Research Base for NCORP studies, including how patient cases are selected for auditing and how data are validated at site and in associated study databases.  Provide information on the number of audits performed by the Research Base for its member institutions since during the current funding period. In general, the NCI Clinical Trials Monitoring Branch (CTMB) Guidelines for Auditing NCTN and NCORP clinical studies require all participating sites to be audited at least once every 36 months. On-site auditing information for Research Base members should be provided in a table by member site category only (not by individual sites).
  • Include major site categories (e.g., main members, affiliates of main members, NCORP Sites),
  • Number of active sites during reporting period,
  • Number of sites terminated during reporting period, number of sites withdrawn during reporting period,
  • Number of routine audits performed and percent of those audits with specific ratings (acceptable, acceptable with follow-up, unacceptable) by audit category (Institutional Review Board/Informed Consent Content, Pharmacy, and Patient Cases) during the reporting period), and
  • Number of re-audits and off-cycle audits performed and percent of those audits with specific ratings (acceptable, acceptable with follow-up, unacceptable) by audit category (Institutional Review Board/Informed Consent Content, Pharmacy, and Patient Cases) during the reporting period).
  • Note:  Sites that are terminated or withdrawn within the reporting period and later re-activated should still be counted in the columns of the report if they were audited.
  • New Applicants:  Provide documentation of the auditing policy for the proposed Research Base for clinical studies, including how patient cases will be selected for auditing and how data will be validated at site and in associated study databases.

Attachment 7:  Operational Timelines for Development of Clinical Trials and Related Studies (use filename: Study Timelines).

  • For Renewal applications:  Provide information on the timeline for the development and activation/opening of NCORP studies. This information should be provided only for NCORP studies that activated during the current funding period. This information should be provided in a series of tables so that the data can be provided separately by scientific area (cancer control, prevention, and care delivery) and study design (clinical trial, longitudinal/cohort, observational, descriptive).

For New applications:    Provide information on the timeline for the development and activation/opening of clinical studies designed and conducted by the applicant group. This information should be provided only for clinical studies activated in the past 5 years. This information should be provided in a series of tables so that the data can be provided separately by scientific area (cancer control, prevention, and care delivery) and study design (clinical trial, longitudinal/cohort, observational, descriptive).

Attachment 8:  Data Management and Monitoring Policies & Procedures for Clinical Studies (use filename: Data Management and Monitoring).

  • Provide documentation of key procedures for data management and monitoring policies for clinical studies, including risk-based central monitoring.

Attachment 9:  Key Procedures to Ensure Security and Confidentiality of Patient Data (use filename: Securing Patient Confidentiality).

  • Provide documentation of key procedures for ensuring the security and confidentiality of patient data, including protected health information.
SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed. 

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed. The following additional instructions apply.

A minimal effort level of 1.2 person-months is required for each PD/PI regardless of whether that individual is designated as contact PD/PI or not.  (This commitment cannot be reduced below that level during the projects period).

In the Budget Justification attachment, in addition to standard items for this attachment, provide a breakdown of the direct costs to show separate dollar amounts for both Control/Prevention and Cancer Care Delivery research activities. Do this for each budget period requested. Provide such information for each budget category where funds are requested.

The following costs are not supported under this FOA;

  • Costs associated with routine patient care.
  • Funds for tumor banks, correlative science research and/or reference laboratories.
  • Funds for integral and/or integrated laboratory and/or biomarker studies
  • Costs for alterations and renovations.
R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.  

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims:  Describe the overall Specific Aims for the proposed Research Base addressing the development and conduct of cancer prevention, control, and care delivery (CPC&CCD) research.  The study design, methods, and/or interventions for these areas of research may not by themselves be innovative but address important questions or unmet needs.  Explain how the completion of these Aims is expected to advance oncology care and reduce disparities in cancer care and outcomes.

Research Strategy:  Organize the Research Strategy section with sub-sections in the specified order and follow the instructions provided below. Start each subsection with the appropriate subsection heading.

Subsection A. Developing and Implementing the Scientific Agenda - Address the following areas:

Overview

Outline the overall strategy and approaches that the applicant team will use to develop and implement its research agenda.

  • For new applications:  Identify the specific areas of research that the applicant team plans to pursue from the three (3) Areas referenced under the "Scope of Activities for Research Base" and explain how the proposed research agenda will benefit the NCORP Program.
  • For renewal applications:  Identify the specific areas of research that the Research Base will continue to pursue from the three (3) Areas referenced under the "Scope of Activities for Research Base" and/or any new directions planned. Explain how the research priorities will benefit the NCORP Program.
  • For new and renewal applications:  Explain how the proposed research agenda will improve scientific knowledge and/or clinical practice.

Progress Report

For Renewal applicants:

  • Highlight the most significant achievements in terms of clinical studies designed, activated, and analyzed during the recent project period as well as patient enrollment by its Research Base Members to studies (led by the applicant Research Base and other Network Groups).  Provide this information by scientific area, i.e., cancer control, prevention, care delivery.
  • Describe how the applicant has integrated and centralized functions to form an efficient operational organization for its Research Base Members that participate in NCORP research.
  • Highlight the Research Base's major contributions to the overall infrastructure of the NCORP Network and significant collaborations with other NCI-sponsored programs.

For New applicants:

  • Provide the highlights of major contributions to cancer-related clinical research, including NCI-supported clinical trials through the venues in which the applicant organization has had access over the last 5 years.

Research Priorities

  • Explain the strategies that will set or sets priorities and timelines for development of clinical studies for the NCORP network.
  • Describe any novel (or refinements/improvements) concepts, approaches, or methods that are being developed or used and any advantage that they may have over existing methods with respect to the development, design, and conduct of clinical studies.
  • Explain how the applicant proposes to integrate cancer disparities research into human subject studies to improve cancer care and outcomes for diverse populations.
  • Explain how the applicant will incorporate translational science (including integral and integrated biomarkers) into its clinical trials.
  • Describe how the applicant will use the NCORP biospecimen banks as a scientific resource to inform future research studies.
  • Describe how the applicant will use the NCORP Imaging and Radiation Oncology Core resources, if applicable, to integrate advanced technology into research studies. 

Statistics and Data Management

  • Describe the role of the statisticians and community representatives and at what point in the process their input is incorporated into trial development.
  • Describe how the statistician interacts with the study chair. 
  • From the statistics perspective, describe the general strategy and approaches to study design and analysis plans for multi-institutional clinical studies, including guidelines for interim monitoring and general procedures for sample size estimation and choice of testing and estimation procedures.
  • Describe how the senior statisticians of the proposed Research Base provide leadership in study design and analysis
  • Describe what policies the applicant has in place to ensure that final study analyses are performed in a manner to provide timely publication of study results and results reporting per NIH/NCI, NCORP, and federal regulations.

Accruals

  • Explain how the proposed Research Base will ensure the appropriate enrollment of patients across the cancer trajectory and in diverse populations, e.g., racial/ethnic minorities, those of varied sexual and gender identities, AYA and the elderly, and other underserved or underrepresented populations.
  • Describe what resources and tools (NCI or others) will inform plans to ensure enrollment, e.g., screening log, administrative and PI webinars.
  • Describe how the proposed Research Base will strategically engage NCORP sites to create recruitment plans to achieve proposed accrual goals.

Investigator Participation throughout the NCORP Network

  • Characterize the extent to which individuals playing distinct roles (such as investigators, patient advocates, and other members of the oncology and non-oncology community) participate in the design, conduct, and monitoring of clinical studies.
  • Outline how the affiliated NCORP Community Sites, NCORP Minority/Underserved Community Sites and other institutional members will be involved in Research Base activities (e.g., committee memberships, study chair roles, training programs, anticipated scientific collaborations, etc.).
  • Explain how the proposed Research Base and its committee structure will promote interdisciplinary exchange in the development and conduct of CPC&CD research.
  • Explain how the proposed Research Base will contribute to the overall infrastructure of the NCORP Program through examples of participation in the Scientific Steering Committees under the NCI Coordinating Center for Clinical Trials (https://www.cancer.gov/about-nci/organization/ccct/about )and associated Task Forces and Working Groups, the NCI Central IRB, and other NCI/NCORP initiatives.
  • For renewal applications:  Describe the Research Base’s current collaborations and plans for new collaborations with other NCORP Research Bases on clinical studies as well as other aspects of study design and conduct.
  • For new applications:  Describe the applicants past and proposed collaborations and other future plans for research activities with other NCORP Research Bases on clinical studies.

Subsection B. Organizational Leadership, Structure and Operational Management - Address the following areas:

Administrative Leadership

  • Describe the senior administrative leadership team and the organizational structure of the proposed Research Base and its key governance policies. The applicant should also provide a diagram illustrating the organizational structure of the proposed Research Base.
  • Describe the chain of responsibility for decision making and conflict resolution at the proposed Research Base as well as succession planning for senior leadership positions.
  • Describe the communication process within the organizational structure, e.g., to Committees and to community investigators.
  • Describe how administrative functions are centralized for efficiency.

Operational Capacity/Oversight

  • Describe the proposed Research Base’s capability to develop, activate, conduct, and monitor clinical studies in a timely manner.
  • Describe how the proposed Research Base provides oversight and coordination of study development, patient accrual, study conduct (e.g., at community sites enrolling both children and adults), and on-site auditing for NCORP studies. 
  • The applicant should describe the data management systems employed and how the proposed Research Base will use standard NCI tools including the Common Data Management System (CDMS), the Regulatory Support System (RSS), the Oncology Patient Enrollment Network (OPEN), the  Clinical Data Update Systems (CDUS/CDS) or the new CTEP AERS System, the NCI Common Terminology Criteria for Adverse Events (CTCAE) for data management, and trial registration in the NCI National Clinical Trials Reporting Program (CTRP) and in the U.S. National Library of Medicine (NLM) (www.clinicaltrials.gov) along with results reporting, as applicable.
  • Describe how the information technology (IT) support for central storage, security, analysis and retrieval of clinical data for the Data Safety and Monitoring Committees will adequately support clinical trial and other human subjects research.
  • Describe the applicant's methods and procedures for biospecimen collection tracking; assessing case eligibility and evaluability; and, ensuring timely medical review and assessment of patient data.
  • Explain the proposed Research Base’s guidelines for Community and Minority/Underserved Community Site data submission, including a summary of data quality.

Scientific Leadership

  • Define lines of responsibilities in terms of pursuing the goals and research agenda of the proposed Research Base.
  • Describe the applicant’s senior research teams (e.g., scientific research committees and administrative committees) and the processes these teams follow to develop the research agenda of the proposed Research Base.
  • Summarize the collective capabilities and experience of the proposed Research Base’s development team in successfully developing, organizing, and coordinating research studies within the NCORP scope as well as experience in leveraging resources from multiple funding sources for the conduct of ancillary studies (e.g., correlative science studies) associated with clinical studies.
  • Describe how the proposed Research Base will provide appropriate orientation for:
  • Scientific Committee Chairs;
  • Research Base member sites [e.g., for protocol chairs, institutional site PD(s)/PI(s), and clinical research associates (CRAs)].
  • Outline the general strategies anticipated by the team leadership for other relevant research-enhancing activities (such as mentoring new/junior investigators, promoting diversity among Research Base investigators, etc.).

Subsection C. Challenges to Concept Development of Clinical Studies for NCORP Community Investigators -Address the following areas:

For Renewal applicants:

  • Explain the importance of the proposed Research Base’s objectives, including overarching problems or critical barriers to developing scientifically important and relevant studies and ensuring the appropriate enrollment of patients across the cancer trajectory and in special populations (including minority and underserved populations, AYAs, and the elderly).

For New applicants provide:

  • Describe research activities within the applicant's organization that may contribute to the goals and success of the proposed Research Base.
  • Explain how the applicant organization is positioned to address known barriers to clinical trial enrollment and related studies.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Given that applicants should not propose any specific clinical trials at the time of application, Study Record should NOT be completed.

Delayed Onset Study

All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:

Both Renewal and New Applications must add and complete the Delayed Onset Study record and must check box "Anticipated Clinical Trial?".

Study Title-- use:  "Multiple Delayed Onset Studies"

Justification Attachment:  Indicate that the clinical trials will be designed and conducted by the NCORP Research Base during the Project Period. Each clinical trial protocol developed will be subject to approval through the standard NCI procedure that involves an initial concept submission and subsequent review.  If the concept receives approval, the next stage will be development of the protocol, which also must undergo review and approval by one of the three NCI Coordinating Center for Clinical Trials (CCCT) dedicated scientific Steering Committees (Symptom Management & Quality of Life, Cancer Care Delivery, and Cancer Prevention) prior to activation through the NCORP network. Indicate areas of oversight, regulatory compliance monitoring, etc. that will be the responsibility of the proposed Research Base. Indicate aspects of study development and implementation in which Research Base will work jointly with affiliated Community Sites.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must be followed. 

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 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.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) 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 electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. 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:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(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. See Section III of this FOA for information on registration requirements.

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 System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NCI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information
1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

As this FOA is to support the essential NCORP clinical trials infrastructure, reviewers will assess to what degree the proposed Research Base will be able to fulfill all the required functions, including rigorous study design, focus on interventions that address clinically important questions or unmet needs, as well as optimal interactions with NCI and the member sites enrolling patients to clinical trials. 

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy?  For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?   

In addition, specific for this FOA: Is there a strong scientific premise for the Research Base proposed priorities and menu of clinical trials and other human subject studies in cancer control, prevention, and care delivery for the NCORP network?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? 

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

In addition, specific for this FOA: How well does the proposed leadership for the Research Base have the expertise and the ability to organize, manage, and implement the comprehensive clinical trials and other human subject studies menu proposed for the NCORP network?

How well does the organizational structure support the administrative leadership for the proposed Research Base?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? 

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? 

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Does the application adequately address the following, if applicable?

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? 

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Study Timeline

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

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, the committee 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, the committee 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

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (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

Reviewers 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.

Resubmissions

Not Applicable.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NCI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

  • Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned  to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.
3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information
1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. 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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA. 

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/ 

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.  Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

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 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 http://www.hhs.gov/ocr/civilrights/understanding/section1557/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 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 https://www.hhs.gov/ocr/about-us/contact-us/index.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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement - an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities.  Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibilities for:

  • Development of research strategy for clinical trials and related studies for cancer prevention, control, screening and care delivery across a range of cancer types and appropriate conduct, monitoring, and results reporting of NCI-approved trials.
  • Development of an overall strategy to provide statistical expertise for effective scientific design, conduct, and data management of clinical trials and other human subjects research led by the associated NCORP Research Base(s).
  • Recruitment of Research Base member sites for diverse patient enrollment to NCORP trials and oversight of member sites for the conduct of trials they participate in across the NCORP, including evaluation of member site performance and auditing per NCTN Program Clinical Trials Monitoring Branch (CTMB) Guidelines.
  • Provision of clinical trial data for NCI/DCP-approved correlative science studies using banked bio-specimens from NCORP trials.
  • Use of NCTN Program's common data management system including use of NCTN reporting tools for adverse event reporting and risk-based central monitoring.
  • Mentoring of new/junior investigators as well as patient advocates in clinical trials research/activities.
  • Ensuring that all U.S. member sites are members of the NCI CIRBs and use the NCI CIRB for all NCORP multi-site clinical trials and eligible related studies. 
  • Provision of standard operating procedures covering all aspects of clinical trial design, trial conduct (including compliance with Good Clinical Practice (GCP) guidelines and risk-based central monitoring for applicable NCORP trials), development and compliance with data safety/monitoring plans and Data Safety Monitoring Board policy for applicable trials, and training for Clinical Research Associates (CRAs) at member participating sites and Study Chairs/Teams about their responsibilities for study monitoring and data management.
  • Participation in the collective management of the NCORP, including participation in appropriate NCORP/NCTN Program activities and initiatives (e.g., NCI Scientific Steering Committees, Correlative Science Committee).
  • Providing oversight of the conduct of clinical trials in NCORP Community Sites and Minority/Underserved Community Sites, including the responsibility for data management, reporting, and required regulatory compliance
  • Compliance with NCORP/NCTN Program/NCI/NIH timelines and policies for registration of clinical trials in clinicaltrials.gov and NCI's Clinical Trials Reporting Program (CTRP), publication, and trial data deposit in the NCTN/NCORP Data Archive and NCTN Navigator System.
  • Compliance with Part 1 of the NCI Community Oncology Research Program Guidelines dated May 2018 and any subsequent updated versions of the Guidelines (https://ncorp.cancer.gov/resources/applicants/guidelines.pdf).
  • Awardees will comply with the Handbook for Clinical Investigators Conducting Therapeutic Clinical Trials Supported by CTEP, DCTD, NCI at (https://ctep.cancer.gov/investigatorResources/investigators_handbook.htm), the (https://ctep.cancer.gov/branches/ctmb/clinicalTrials/monitoring_coop_ccop_ctsu.htm), and the NCI/DCTD CRADA agreements, and the Intellectual Property Option to Collaborators at (https://ctep.cancer.gov/branches/rab/intellectual_property_option_to_collaborators.htm) for NCTN trials and other clinical trials conducted under a NCI/DCTD Investigational New Drug (IND) Application and/or Investigational Device Exemption (IDE).

In addition:

  • Program Directors/Principal Investigators may be expected to supply additional progress-related information, in addition to the standard annual Research Performance Progress Report (RPPR) submission.
  • Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

Designated NCI Program Director(s) will have substantial involvement as a Project Scientist(s).

Additionally, an NCI Program Director, acting as Program Official will be responsible for the normal,

scientific and programmatic stewardship of the award and will be named in the award notice.

A Program Official may also have substantial programmatic involvement (as a Project Scientist).

Activities of substantially involved NIH staff members will include:

  • Ensuring that clinical trials proposed are within the research scope of the NCORP Program.
  • Set priorities for prevention, control and care delivery research trials/studies based on the state of the science, Research Base resources and availability of funding.
  • Finalizing reviews of clinical trial concepts after evaluation by NCI Scientific Steering Committees or DCP as well as review of final protocols and subsequent amendments for all NCORP trials.
  • Serve as a resource for scientific information on trial/study design.
  • Approval of foreign sites, if applicable, as a member(s) to the Research Base.
  • Evaluation and approval of clinical trial collaborations with non-NCORP, non-U.S. trial sites and organizations including review of any agreements/MOUs for compliance with NIH/NCI, federal, and NCORP policies. Review and approval of agreements/MOUs between the U.S. Groups and other entities related to NCORP trials for compliance with NCI/NIH, federal, and NCORP policies.
  • Serving as scientific liaisons to all NCORP awardees of the NCORP Program and participation in scientific meetings of this key component as well as informing Network investigators of scientific opportunities resulting from NCI-supported clinical research programs.
  • Sponsor strategy sessions, when indicated, to discuss specific research initiatives.
  • Oversight of data management and monitoring programs for NCORP trials as well as onsite auditing programs and quality assurance programs.
  • Facilitating coordination of the clinical trial activities and collaborations between the NCORP Network and other NCI-sponsored programs and investigators.
  • Approve the final dollar amounts that are paid to sites for all approved element(s) of NCI NCORP protocols made available to sites from the NCORP Research Bases.
  • Final review and approval of requests for use of any bio-specimens collected per the approved protocol for NCORP trials.
  • Ensuring compliance with FDA for investigational agents and ensuring compliance with OHRP and other federal regulations for research involving human research subjects including compliance with Good Clinical Practice (GCP) guidelines:  http://www.fda.gov/oc/gcp/default.htm and https://ctep.cancer.gov/branches/ctmb/clinicalTrials/docs/good_clinical_practices.pdf  for applicable NCORP trials.
  • Monitoring the progress and performance of the Research Base as a key component of the NCORP Program.
  • Oversight of data and safety monitoring plans and boards for NCORP clinical trials.
  • Participate in on-site audits of NCORP Community Sites and/or Minority/Underserved Community Sites conducted by Research Bases, when appropriate.
  • The NCI will have access to all data (including imaging data) collected and/or generated under this Cooperative Agreement and may periodically review the data.

Areas of Joint Responsibility include:

  • General aspects of collaboration on study development and conduct especially with respect to compliance with federal regulations for clinical trial research, conduct of Data and Safety Monitoring Boards (DSMBs) for phase 3 trials and randomized phase 2 trials.
  • Review of recommendations from the NCI Clinical Trials and Translational Research Advisory Committee (CTAC) on strategic directions for the NCORP Program.
3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described 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)

Worta McCaskill-Stevens, M.D.
National Cancer Institute (NCI)
Telephone: 240-276-7050
Email: mccaskiw@mail.nih.gov

Peer Review Contact(s)

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: ncirefof@dea.nci.nih.gov

Financial/Grants Management Contact(s)

Sean Hine
National Cancer Institute (NCI)
Telephone: 240-276-6291
Email: hines@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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