Developing Biomarkers for Trastuzumab-induced Cardiotoxicity

The summary for the Developing Biomarkers for Trastuzumab-induced Cardiotoxicity 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.

Developing Biomarkers for Trastuzumab-induced Cardiotoxicity: This award is intended to provide support to conduct clinical studies at a clinical site with capability and patients samples to investigate potential biomarker (cMLC1) for trastuzumab-induced cardiotoxicity. 1) There will be an establishment of the assay to quantitatively measure cMLC-1 in humans. 2) Investigations will be conducted to determine the value of cMLC-1 in humans as an early predictor of cardiotoxicity in a pilot study. A comparison will be done of the level of cMLC-1 in 5 patients who subsequently developed cardiotoxicity and 5 patients who did not. Patients will be matched for age. Cardiotoxicity was defined using the Cardiac Review and Evaluation Committee for Trastuzumab (CREC) criteria as a decrease of more than 10% in the echocardiographic left ventricular ejection fraction to a value of less than 55%. 3) Women were monitored every 3 months for 15 months. 4) The archived plasma samples collected at multiple time points indicated below schematically will be tested for the biomarker cMLC-1 and for troponin I, an established marker for heart muscle damage as a control.

Federal Grant Title:	Developing Biomarkers for Trastuzumab-induced Cardiotoxicity
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-17-006
Type of Funding:	Grant
CFDA Numbers:	93.103
CFDA Descriptions:	Information not provided
Current Application Deadline:	July 10th, 2017
Original Application Deadline:	July 10th, 2017
Posted Date:	May 23rd, 2017
Creation Date:	May 23rd, 2017
Archive Date:	August 23rd, 2017
Total Program Funding:	$140,000
Maximum Federal Grant Award:	$140,000
Minimum Federal Grant Award:	$140,000
Expected Number of Awards:	1
Cost Sharing or Matching:	No
Last Updated:	May 22nd, 2017

Applicants Eligible for this Grant: Others (see text field entitled "Additional Information on Eligibility" for clarification.)
Additional Information on Eligibility: 1. Eligible ApplicantsEligible OrganizationsHigher 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 FDA support as Public or Private Institutions of Higher Education: o Hispanic-serving Institutionso Historically Black Colleges and Universities (HBCUs)o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutionso 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• Small Businesses• For-Profit Organizations (Other than Small Businesses)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)• Eligible Agencies of the Federal Government• U.S. Territory or PossessionOther• 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• Non-domestic (non-U.S.) Entities (Foreign Institutions) Foreign InstitutionsNon-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 HHS Grants Policy Statement, are not allowed.
Link to Full Grant Announcement: FOA
Grant Announcement Contact: Shashi Malhotra
Grants Management Specialist
Phone( 240)402-7592
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