Harmonization of Technical Requirements for Pharmaceuticals for Human Use (U01)

The summary for the Harmonization of Technical Requirements for Pharmaceuticals for Human Use (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 Drug Administration, which is the U.S. government agency offering this grant.
Harmonization of Technical Requirements for Pharmaceuticals for Human Use (U01): The Food and Drug Administration announces its intention to consider and accept a single source application for award to the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). The purpose of this program is to provide support in convening leading global drug regulatory agencies and pharmaceutical manufacturer associations to achieve greater harmonization of technical standards to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. The outcome of this effort will be a series of guidelines internationally recognized and categorized into four main topics:

1. Quality Guidelines: Harmonization achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.

2. Safety Guidelines: A comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity.

3. Efficacy Guidelines: The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety, and reporting of clinical trials. It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics/ pharmacogenomics techniques to produce better targeted medicines.

4. Multidisciplinary Guidelines: These are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories. It includes the Common Technical Document (CTD), and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI).
Federal Grant Title: Harmonization of Technical Requirements for Pharmaceuticals for Human Use (U01)
Federal Agency Name: Food Drug Administration
Grant Categories: Consumer Protection Food and Nutrition Health
Type of Opportunity: Discretionary
Funding Opportunity Number: RFA-FD-15-014
Type of Funding: Cooperative Agreement
CFDA Numbers: 93.103
CFDA Descriptions: Food and Drug Administration_Research
Current Application Deadline: Sep 30, 2015
Original Application Deadline: Sep 30, 2015
Posted Date: May 18, 2015
Creation Date: May 18, 2015
Archive Date: Oct 30, 2015
Total Program Funding: $500,000
Maximum Federal Grant Award: $500,000
Minimum Federal Grant Award: none
Expected Number of Awards: 1
Cost Sharing or Matching: No
Applicants Eligible for this Grant
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Additional Information on Eligibility
Only the following organization is eligible to apply: International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).

Link to Full Grant Announcement
Federal Register Notice of RFA-FD-15-014
Grant Announcement Contact
Lisa Ko Grants Management Specialist
[email protected]

Food & Drug Administration 301-443-5869
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