Dissolution Methods for Long-acting Levonorgestrel Intrauterine System (U01)

The summary for the Dissolution Methods for Long-acting Levonorgestrel Intrauterine System (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.
Dissolution Methods for Long-acting Levonorgestrel Intrauterine System (U01): There is a lack of compendial or biorelevant in vitro drug release assays for long-acting contraceptive intrauterine systems. The objective of this study is to investigate dissolution methods, both real time and accelerated conditions, for levonorgestrel intrauterine system (5-year application) and to analyze their capability of detecting manufacturing differences, predicting in vivo performance, and to evaluate method robustness. The results from this study will help the FDA in developing recommendations to determine bioequivalence of generic intrauterine systems.
Federal Grant Title: Dissolution Methods for Long-acting Levonorgestrel Intrauterine System (U01)
Federal Agency Name: Food Drug Administration
Grant Categories: Consumer Protection Food and Nutrition Health
Type of Opportunity: Discretionary
Funding Opportunity Number: RFA-FD-15-006
Type of Funding: Cooperative Agreement
CFDA Numbers: 93.103
CFDA Descriptions: Food and Drug Administration_Research
Current Application Deadline: Apr 27, 2015
Original Application Deadline: Apr 27, 2015
Posted Date: Feb 17, 2015
Creation Date: Feb 17, 2015
Archive Date: May 27, 2015
Total Program Funding: $125,000
Maximum Federal Grant Award: $125,000
Minimum Federal Grant Award: none
Expected Number of Awards: 1
Cost Sharing or Matching: No
Applicants Eligible for this Grant
County governments
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Small businesses
Native American tribal governments (Federally recognized)
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
State governments
Public housing authorities/Indian housing authorities
Independent school districts
City or township governments
Public and State controlled institutions of higher education
For profit organizations other than small businesses
Native American tribal organizations (other than Federally recognized tribal governments)
Private institutions of higher education
Special district governments
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. - See more at: http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-15-006.html#sthash.60X4gtYR.dpuf
Link to Full Grant Announcement
Full Announcement of RFA-FD-15-006 on NIH Guide for Grants and Contracts
Grant Announcement Contact
Lisa Ko Grants Management Specialist
lisa.ko@fda.hhs.gov

Food & Drug Administration 301-443-5869
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