FDA Grant: Data Collection for NTI Drug Classification (U01)

The FDA is offering a grant to collect dose adjustment and therapeutic monitoring data to aid in the classification of Narrow Therapeutic Index (NTI) drugs. This data will help determine which drugs fall into the NTI category and require tighter review criteria, ultimately assisting the FDA in developing a list of NTI drugs and implementing relevant policies. Researchers are encouraged to submit proposals before the closing date on May 17, 2013.

Opportunity ID: 228882

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General Information

Document Type::	Grants Notice
Funding Opportunity Number::	RFA-FD-13-020
Funding Opportunity Title::	Collection of Dose Adjustment and Therapeutic Monitoring Data to Aid Narrow Therapeutic Index Drug Classification (U01)
Opportunity Category::	Discretionary
Opportunity Category Explanation::
Funding Instrument Type::
Category of Funding Activity::	Consumer Protection
Category Explanation::
Expected Number of Awards::	2
Assistance Listings Number(s)::	93.103 — Food and Drug Administration_Research
Cost Sharing or Matching Requirement::	No
Version::	Synopsis 2
Posted Date::	Apr 02, 2013
Last Updated Date::	May 17, 2013
Original Closing Date for Applications::	May 17, 2013
Current Closing Date for Applications::	May 17, 2013
Archive Date::	Jun 16, 2013
Estimated Total Program Funding::	$ 500,000
Award Ceiling::	$250,000
Award Floor::	$

Eligibility

Eligible Applicants::

Public and State controlled institutions of higher education

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.

Additional Information

Agency Name::	Food and Drug Administration
Description::	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.
Link to Additional Information::
Grantor Contact Information::	If you have difficulty accessing the full announcement electronically, please contact:

Version History

Version	Modification Description	Updated Date
Synopsis 2	Updated anticipated number of awards and total program funding.	May 17, 2013
Synopsis 1

Package Status

Below are CLOSED Opportunity Package(s) no longer available for this Funding Opportunity:

Package No: 1

Assistance Listings:	93.103
Competition ID:
Competition Title:
Opportunity Package ID:	PKG00172099
Opening Date:	Apr 15, 2013
Closing Date:	May 17, 2013
Agency Contact Information::	Lisa Ko
Who Can Apply::	Organization Applicants
mendatory_forms	SF424 (R & R) [V1.2] Project/Performance Site Location(s) [V1.4] Research And Related Other Project Information [V1.3] Research And Related Senior/Key Person Profile (Expanded) [V1.2] Research & Related Budget [V1.1] PHS 398 Cover Page Supplement [V1.4] PHS 398 Research Plan [V1.3] PHS 398 Checklist [V1.3]
optional_forms	R & R Subaward Budget Attachment(s) Form 5 YR 30 ATT [V1.2] PHS Cover Letter [V1.2]