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Cooperative Agreements to USA Nonprofits, For-Profits, IHEs, and Agencies for Eligible Cancer Research Clinical Trials

NCI Cancer Screening Research Network: ACCrual, Enrollment, and Screening Sites (ACCESS) Hub (UG1 Clinical Trial Required)


GrantWatch ID# 207843
Agency: Federal

Funding Source
U.S. Department of Health and Human Services (HHS) - National Cancer Institute (NCI)
CFDA Number: 93.393, 93.394, 93.399
Funding or PIN Number: RFA-CA-23-020
Array ( [0] => American Samoa (USA); [1] => Guam (USA); [2] => Puerto Rico (USA); [3] => Virgin Islands (USA); [4] => Northern Mariana Islands (USA); )

Geographic Focus
All USA
USA Territories: American Samoa (USA);   Guam (USA);   Puerto Rico (USA);   Virgin Islands (USA);   Northern Mariana Islands (USA);

Important Dates
LOI Date: 01/28/23
Deadline: 02/28/23 5:00 PM Applicant's Local Time Save

Grant Description
Cooperative agreements to USA and territories entities that provide healthcare, including nonprofit and for-profit organizations, IHEs, Tribes, and agencies, for eligible cancer research clinical trials. Applicants are advised that required registrations may take several weeks to complete.

The primary goal of the Cancer Screening Research Network (CSRN) is the conduct of multi-center cancer screening trials and studies. This Network is designed to take advantage of large and diverse populations receiving routine care in a variety of healthcare settings. The CSRN will engage these populations in rigorous studies focused on cancer screening to improve early cancer detection and evaluate emerging cancer screening modalities with the ultimate goal of reducing cancer incidence, and cancer-related morbidity and mortality.

CSRN ACCESS Hubs will establish multi-disciplinary teams to recruit participants to CSRN trials and studies, conduct the screening protocols, and participate in the scientific development and implementation of those trials and studies.

To support the CSRN goal, ACCESS Hubs will be expected to possess the capacity to contribute the following:

  • A multidisciplinary team of investigators that, together, have expertise in cancer screening and/or other disease screening with a history of successful recruitment and retention of participants to cancer screening and prevention trials or other disease screening trials or studies with the demonstrated collection of high-quality data for those trials or studies.
  • Investigators who will participate in the scientific development of the trials and studies. The principal investigators will participate in the CSRN Steering Committee and other investigators may participate in a variety of working groups or committees.
  • Research staff who will be responsible for entering and ensuring quality control of data from enrollment through study completion including long-term follow-up.
  • Research staff who will ensure regulatory compliance, participant protection requirements, and compliance with the CCC and SDMC’s policies for auditing, training, and quality assurance.
  • Institutions that will be responsible for recruiting, consenting, and registering participants from diverse populations for cancer screening trials and studies.
  • Institutions that will be responsible for performing cancer screening and any diagnostic workup as prescribed by a CSRN-approved protocol or for clinical follow-up.
  • Institutions that will be responsible for research oversight and data monitoring at each of their affiliate organizations.
  • Institutions that will work collaboratively with the CCC and the SDMC. They will ensure trial and study data is securely transferred to the SDMC. ACCESS Hubs will coordinate with the CCC and the SDMC on efforts for long-term data collection through linkages with existing state registries and other entities, such as the virtual pooled registry and the National Death Index.
  • Institutions that will be responsible for specimen collection and will also work with the CCC to coordinate the processing and shipping of all biological samples collected from trial participants to be stored at Frederick National Laboratory for future research, as well as coordinating with the CCC as needed to facilitate the shipment of specimens for protocol testing.
  • A large potential participant population including individuals who are not living with cancer and who are representative demographically of the greater community.


Recipient

Eligibility
  • City or township governments
  • County governments
  • For profit organizations other than small businesses
  • Independent school districts
  • Native American tribal governments (Federally recognized)
  • Native American tribal organizations (other than Federally recognized tribal governments)
  • Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
  • Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
  • Private institutions of higher education
  • Public and State controlled institutions of higher education
  • Public housing authorities/Indian housing authorities
  • Others (see text field entitled "Additional Eligibility Criteria" for clarification)
  • Small businesses
  • Special district governments
  • State governments

Additional Eligibility Criteria
Eligible Organizations:
- Public/State Controlled Institutions of Higher Education
- Private 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)
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations

An eligible institution/organization for the purposes of this application is defined as a healthcare providing entity including, but not limited to, a consortium of academic and community institutions, a healthcare system, practice-based research network, or other institution providing direct medical care to patients that are considered one integral organizational entity under a single financial management system and governance structure.

Applicants that contain multiple types of eligible institutions are welcome to apply.

Only one application per institution is allowed.

Ineligible
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.

The following types of activities remain outside the scope of this FOA, and applications proposing them are non-responsive to this FOA and will not be reviewed:
- Evaluating technology for the purpose of detecting the recurrence of previously treated cancers.
- Applications that do not address NCI’s scientific mission.

Pre-Application Information
Timeline:
- Letter of Intent Due Date: January 28, 2023
- Application Due Date: February 28, 2023
- Scientific Merit Review: July 2023
- Advisory Council Review: October 2023

All applications are due by 5:00 PM local time of applicant organization.

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.

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.

Applicants may submit applications via the NIH ASSIST system or via Grants.gov Workspace.

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.
- System for Award Management (SAM)
- eRA Commons
- Grants.gov

View this opportunity on Grants.gov: https://www.grants.gov/web/grants/view-opportunity.html?oppId=344535

For a list of relevant application documents, go to the Package tab (press Preview) on the Grants.gov link above.

Additional Funding Information

Estimated Total Program Funding:

$8,000,000

Number of Grants
10-15

Estimated Size of Grant
The requested budget must not exceed $750,000 in direct costs per year.

Term of Contract
The maximum project period is 4 years.

Earliest Start Date: December 2023

Contact Information
The letter of intent should be sent to:
Paul Pinsky, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7014
Email: CSRN@nih.gov

ASSIST online application platform: https://public.era.nih.gov/assist/public/login.era?TARGET=https%3A%2F%2Fpublic.era.nih.gov%3A443%2Fassist%2F

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

Scientific/Research Contact(s):

Paul Pinsky, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7014
Email: CSRN@nih.gov

Elyse LeeVan, M.D.
National Cancer Institute (NCI)
Telephone: 240-276-7314
Email: CSRN@nih.gov

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