Rare Disease Clinical Outcome Assessment Consortium (U01 Clinical Trial Not Allowed)

The summary for the Rare Disease Clinical Outcome Assessment Consortium (U01 Clinical Trial Not Allowed) grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Food and Drug Administration, which is the U.S. government agency offering this grant.
Rare Disease Clinical Outcome Assessment Consortium (U01 Clinical Trial Not Allowed): A rare disease is defined by the Orphan Drug Act as a disease that affects less than 200,000 people in the US. As described in FDA draft Guidance, "Rare Diseases: Common Issues in Drug Development Guidance for Industry" (https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm458485.pdf ), fit-for-purpose clinical endpoints for many rare diseases are not available. Selection or development of clinical outcome assessments for use to support efficacy of a treatment in a rare disease can be challenging due to the small sample size of possible participants for participation in instrument development and clinical trials and heterogeneity of the target patient population (e.g., phenotypic or genotypic variations, age, clinical manifestations, variations in patient experience, and rate of disease progression). However, many rare diseases share similar clinical characteristics such as decline in cognition and physical function, which offers an opportunity to explore clinical outcome assessments that may cover a spectrum of rare diseases. This cooperative agreement will provide funding to establish a rare disease consortium focusing on clinical outcome assessments appropriate for use in drug development to demonstrate clinical benefit. Many rare diseases include neurodegenerative decline resulting in loss of ability to perform daily activities. Therefore, domains of interest include, but are not limited to, cognition, adaptive behavior, physical function (e.g., fine motor function, ambulation, speech, swallowing) and assessments of patients' ability to perform activities of daily living. Special considerations that should be addressed include the fact that many rare diseases affect children as well as adults and trials are often multiregional, which necessitates attention to cross-cultural considerations. The final outcome would be the creation of a common resource describing publicly available fit-for-purpose clinical outcome assessments as well as accompanying information, such as the populations for use and the strengths and limitations of each tool. Work in the pre-competitive setting of a consortium where data is shared can enhance the development of this resource and, thus would help to address unmet measurement needs in rare disease drug development.
Federal Grant Title: Rare Disease Clinical Outcome Assessment Consortium (U01 Clinical Trial Not Allowed)
Federal Agency Name: Food and Drug Administration (HHS-FDA)
Grant Categories: Agriculture Consumer Protection Food and Nutrition
Type of Opportunity: Discretionary
Funding Opportunity Number: RFA-FD-19-029
Type of Funding: Cooperative Agreement
CFDA Numbers: 93.103
CFDA Descriptions: Information not provided
Current Application Deadline: July 29th, 2019
Original Application Deadline: July 29th, 2019
Posted Date: June 4th, 2019
Creation Date: June 4th, 2019
Archive Date: August 28th, 2019
Total Program Funding: $300,000
Maximum Federal Grant Award: $300,000
Minimum Federal Grant Award:
Expected Number of Awards: 1
Cost Sharing or Matching: No
Last Updated: June 4th, 2019
Applicants Eligible for this Grant
State governments - County governments - City or township governments - Special district governments - Public and State controlled institutions of higher education - 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 - Individuals - For-profit organizations other than small businesses - Small businesses
Link to Full Grant Announcement
Information not provided
Grant Announcement Contact
Shashi Malhotra
Grants Management Specialist
Phone 2404027592
shashi.malhotra@fda.hhs.gov
Similar Government Grants
FDA Support for Conferences and Scientific Meetings (R13 Clinical Trial Not Allowed)
Drug Development Tools Research Grants (U01 Clinical Trial Not Allowed)
Cigar Tobacco Reference Products Program (UC2) Clinical Trials Not Allowed
Implementation of U.S. Food Safety Modernization Act - Identifying, Researching, and Imple...
Renewal Application: Critical Path Public Private Partnerships (U18) Clinical Trials Optio...
Support for Small Scientific Conference Grant Program
Cooperative Agreement to Support the World Health Organization (WHO) International Program...
Clinical Studies of Safety and Effectiveness of Orphan Products
More Grants from the Food and Drug Administration
FDA Support for Conferences and Scientific Meetings (R13 Clinical Trial Not Allowed)
Drug Development Tools Research Grants (U01 Clinical Trial Not Allowed)
Cigar Tobacco Reference Products Program (UC2) Clinical Trials Not Allowed

FederalGrants.com is not endorsed by, or affiliated with, any government agency. Copyright ©2019 FederalGrants.com