Cooperative Agreements to USA, Canada, and International Agencies, IHEs, Nonprofits, and Businesses for Research Related to Biomarkers

Clinical and Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders

Agency

Federal

GrantWatch ID#

195205

Funding Source

National Institute of Health (NIH) - National Institute of Neurological Disorders and Stroke (NINDS)

CFDA Number: 93.853

Funding or PIN Number: PAR-21-056; PAR-21-057; PAR-21-058; PAR-21-059

Geographic Focus

All USA
USA Territories: American Samoa (USA); Guam (USA); Puerto Rico (USA); Virgin Islands (USA); Northern Mariana Islands (USA);
USA Compact Free Associations:The Federated States of Micronesia (USA) Marshall Islands (USA) Republic of Palau (USA)
International, Israel and Canada.

Important Dates

LOI Date: 05/23/23
Deadline: 06/22/23 5:00 PM

Grant Description

Cooperative agreements to USA, Canada, and International government agencies, IHEs, nonprofit and for-profit organizations, and small businesses for research related to neuromuscular and neurological conditions and disorders. Required registrations may take 6 weeks or more to complete.

PAR-21-056 and PAR-21-057: Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders:

The purpose of these Program Announcements (PAR) is to enable analytical validation of strong candidate biomarkers for neurological and neuromuscular disorders and conditions. Specifically, the goal of these PARs is to enable the rigorous validation of analytical methods for biomarker measurements, which should include evaluation of the detection method, its performance characteristics, and the optimal conditions that will generate reproducibility and accuracy consistent with FDA guidelines. These PARs assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed, and 3) the research and/or clinical need and potential context of use has been identified.

Applicants with a detection method that has already been analytically validated for its intended Context of Use may apply directly to the companion PAR, Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 - Clinical Trial Optional)" which addresses retrospective and/or prospective clinical validation of candidate biomarkers for use in clinical trials and/or clinical practice.

Research Objectives: Applications to these PARs must propose to conduct analytical validation of a biomarker or biomarker signature that already has a well-defined proof of concept and biological rationale. Premise and proof of concept must include evidence that the biomarker/biomarker signature has been tested in an appropriate clinical population, using either prospective or retrospective data or samples and shows sufficient sensitivity and specificity to warrant additional investment. In addition, applications to these PARs must include evidence that the detection method for the biomarker has been developed and subjected to initial evaluation of precision and analytical sensitivity. The application should clearly describe how the proposed study plans to optimize and standardize the detection method, as well as clearly define and rigorously test the analytic and pre-analytic variables to ensure broad and reliable clinical use across multiple sites.

PAR-21-058 and PAR-21-059: Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders:

The purpose of these Program Announcements (PAR) is to enable clinical validation of strong candidate biomarkers for neurological and neuromuscular disorders and conditions. Specifically, the goal of these PARs is to enable the rigorous clinical validation of biomarker measurements within the clinical population of interest to establish the clinical sensitivity and specificity of the biomarker consistent with FDA guidelines. These PARs assume that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed and analytically validated, and 3) the research and/or clinical need and potential context of use has been identified.

If analytical validation of the detection method is still needed, applicants are encouraged to apply for the companion PAR, “Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 - Clinical Trial Optional)”.

Research Objectives: Applications to these PARs must propose to conduct clinical validation of a biomarker or biomarker signature that already has strong proof of concept and biological rationale with evidence that the biomarker measures the concept of interest. Premise and proof of concept must include preliminary evidence that the biomarker/biomarker signature has been tested in an appropriate clinical population, using either prospective or retrospective data or samples and shows sufficient sensitivity and specificity to warrant additional investment. In addition, applications to these PARs must include evidence that the detection method for the biomarker has been analytically validated, with known performance parameters and evidence that the it can be reliably used in multiple sites using a standardized protocol.

Recipient

Eligibility

City or township governments
County governments
For profit organizations other than small businesses
Independent school districts
Indian housing authorities
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 applicants for PAR-21-056 and PAR-21-058:
a) 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)
2) 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)
3) For-Profit Organizations
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
4) Local Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
5) Federal Governments
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession
6) Other
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations

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.
- PAR-21-056: Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
- PAR-21-058: Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Eligible applicants for PAR-21-057 and PAR-21-059:
1) Only United States small business concerns (SBCs) are eligible to submit applications for these opportunities.

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, may be allowed.

Small business concerns that are more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these are NOT eligible to apply to the NIH STTR program.

Pre-Application Information

Key Dates:
- Posted Date: November 19, 2020
- Open Date (Earliest Submission Date): January 22, 2021
- Letter of Intent Due Date(s): 30 days prior to the application due date.
- Application Due Date(s) for PAR-21-056, PAR-21-057, and PAR-21-058: February 22, 2021, June 22, 2021, February 22, 2022, June 22, 2022, February 22, 2023, and June 22, 2023.
- Application Due Date(s) for PAR-21-059: (New Date) March 15, 2021, June 22, 2021, February 22, 2022, June 22, 2022, February 22, 2023, and June 22, 2023
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
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): May 4, 2021, September 7, 2021, May 7, 2022, September 7, 2022, May 7, 2023, September 7, 2023. All applications are due by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on the listed date(s).
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.
- Scientific Merit Review: June 2021, October 2021, June 2022, October 2022, June 2023, October 2023
- Advisory Council Review: October 2021, January 2022, October 2022, January 2023, October 2023, January 2024
- Earliest Start Date: November 2021, February 2022, November 2022, February 2023, November 2023, February 2024
- Expiration Date: September 08, 2023

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.

For more information, see the Program Announcements at:
- PAR-21-056 - Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional): https://grants.nih.gov/grants/guide/pa-files/PAR-21-056.html
- PAR-21-057- Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional): https://grants.nih.gov/grants/guide/pa-files/PAR-21-057.html
- PAR-21-058 - Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional): https://grants.nih.gov/grants/guide/pa-files/PAR-21-058.html
- PAR-21-059 - Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional): https://grants.nih.gov/grants/guide/pa-files/PAR-21-059.html

Required Registrations:
Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible.
- Dun and Bradstreet Universal Numbering System (DUNS) - http://fedgov.dnb.com/webform
- System for Award Management (SAM) – https://www.sam.gov/portal/public/SAM/
- (PAR-21-057 and PAR-21-059) SBA Company Registry – http://sbir.gov/registration
- eRA Commons - https://grants.nih.gov/grants/guide/url_redirect.htm?id=11123
- (PAR-21-057 and PAR-21-059) Grants.gov – https://grants.nih.gov/grants/guide/url_redirect.htm?id=82300

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
1) Use the NIH ASSIST system to prepare, submit and track your application online.
2) Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons (http://public.era.nih.gov/commons/) to track your application. Check with your institutional officials regarding availability.
3) Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.

View these opportunities on Grants.gov:
- PAR-21-056: https://www.grants.gov/web/grants/view-opportunity.html?oppId=329894
- PAR-21-057: https://www.grants.gov/web/grants/view-opportunity.html?oppId=329916
- PAR-21-058: https://www.grants.gov/web/grants/view-opportunity.html?oppId=329936
- PAR-21-059: https://www.grants.gov/web/grants/view-opportunity.html?oppId=329917

Number of Grants

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

Estimated Size of Grant

- PAR-21-056: Application budgets are not limited but should to reflect the actual needs of the proposed project.
- PAR-21-057: Budgets up to $700,000 total costs per year for Phase I and up to $1,500,000 total costs per year for Phase II may be requested.
- PAR-21-058: Application budgets are not limited but need to reflect the actual needs of the proposed project.
- PAR-21-059: Budgets up to $700,000 total costs per year for Phase I and up to $1,500,000 total costs per year for Phase II may be requested.

Term of Contract

- PAR-21-056 and PAR-21-058: The scope of the proposed project should determine the project period. The maximum project period is 5 years.
- PAR-21-057 and PAR-21-059: According to statutory guidelines, award periods normally may not exceed 6 months for Phase I and 2 years for Phase II. Applicants are encouraged to propose a project duration period that is reasonable and appropriate for completion of the research project. Durations up to 2 years for Phase I and up to 3 years for Phase II may be requested.

Contact Information

Apply Online Using ASSIST: https://public.era.nih.gov/assist/public/login.era?

Send Letters of Intent to:
Carol Taylor-Burds, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1779
Email: carol.taylor-burds@nih.gov

Application Submission Contacts:
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015

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

SBA Company Registry (Questions regarding required registration at the SBA Company Registry and for technical questions or issues)
Website to Email: http://sbir.gov/feedback?type=reg

For Scientific Research Contacts, Peer Review Contacts, and Financial/Grants Management Contacts, see Program Announcement websites in Pre-Application Information above.

Cooperative Agreements to USA, Canada, and International Agencies, IHEs, Nonprofits, and Businesses for Research Related to Biomarkers

Clinical and Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders

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