Collection of Dose Adjustment and Therapeutic Monitoring Data to Aid Narrow Therapeutic Index Drug Classification (U01)

The summary for the Collection of Dose Adjustment and Therapeutic Monitoring Data to Aid Narrow Therapeutic Index Drug Classification (U01) 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.
Collection of Dose Adjustment and Therapeutic Monitoring Data to Aid Narrow Therapeutic Index Drug Classification (U01): Narrow therapeutic index (NTI) drugs are those drugs where small differences in dose or blood concentration may cause serious adverse events or therapeutic failure. In 2011, FDA proposed tighter quality and bioequivalence (BE) standards for NTI drugs. These new standards will further enhance the quality and therapeutic equivalence of generic NTI drugs. One challenge in implementing tighter quality and bioequivalence (BE) standards for NTI drugs is to identify drugs that can be classified as NTI drugs. It is believed that dose adjustment and therapeutic monitoring data in clinical practice can provide insight about the drug dose/concentration and response relationship which may help determine which drug falls into NTI category and may need tighter review criteria. The objective of this application is to collect drug dose adjustment and therapeutic monitoring data in patients to aid NTI classification. The outcome of this study can help FDA develop a NTI drug list and implement the NTI policy.
Federal Grant Title: Collection of Dose Adjustment and Therapeutic Monitoring Data to Aid Narrow Therapeutic Index Drug Classification (U01)
Federal Agency Name: Food and Drug Administration
Grant Categories: Consumer Protection Food and Nutrition Health
Type of Opportunity: Discretionary
Funding Opportunity Number: RFA-FD-13-020
Type of Funding: Cooperative Agreement
CFDA Numbers: 93.103
CFDA Descriptions: Food and Drug Administration_Research
Current Application Deadline: May 17, 2013
Original Application Deadline: May 17, 2013
Posted Date: Apr 02, 2013
Creation Date: Apr 02, 2013
Archive Date: Jun 16, 2013
Total Program Funding: $250,000
Maximum Federal Grant Award: $250,000
Minimum Federal Grant Award:
Expected Number of Awards: 1
Cost Sharing or Matching: No
Applicants Eligible for this Grant
State governments - County governments - City or township governments - Special district governments - Independent school districts - Public and State controlled institutions of higher education - Native American tribal governments (Federally recognized) - Public housing authorities/Indian housing authorities - 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 - For profit organizations other than small businesses - Small businesses - Others (see text field entitled "Additional Information on Eligibility" for clarification)
Additional Information on Eligibility
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the HHS Grants Policy Statement, are allowed.
Grant Announcement Contact
Lisa Ko Grants Management Specialist

[email protected] [[email protected]]
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