Advancing Regulatory Science Through Development of Innovative Methodologies in the area of Antimicrobial Development (U01)

The summary for the Advancing Regulatory Science Through Development of Innovative Methodologies in the area of Antimicrobial Development (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.
Advancing Regulatory Science Through Development of Innovative Methodologies in the area of Antimicrobial Development (U01): PLEASE NOTE: The correct contact information for the project officer is as follows: Nancy Masiello Telephone: 301-796-8498 and FAX: 301-847-8614. FDA is announcing an FOA for research into innovative methodologies in the area of antimicrobial development that can have an impact on the selection of the appropriate dosing and/or combination regimens to prevent emergence of antimicrobial resistance.This FOA is part of the Critical Path Initiative's (CPI's) long-term strategic effort to drive innovation in medical product development. CPI forms a key component of a broader FDA initiative, Advancing Regulatory Science, which focuses on developing new tools, standards, and approaches to assess the safety, efficacy, quality and performance of all FDA-regulated products.There is growing concern over the development of antimicrobial resistance. Even newer antimicrobials such as fluoroquinolones which formerly showed excellent broad spectrum activity are losing their value as the prevalence of resistant organisms continues to increase. Strategies have been explored to curtail the development of resistance. These range from restricting the use of certain antimicrobials, to elaborate infection control measures to prevent the spread of these organisms, to programs for antimicrobial stewardship.Mounting evidence suggests that combinations of antimicrobials and/or high dose and short duration therapy are promising strategies to combat the emergence of resistance. High drug exposure is often necessary to suppress the emergence of resistance and can involve increase in dose, or dosing frequency, or changes in the method of dose administration (e.g., extending infusion time). Combination antimicrobial therapy might prevent emergence of resistance by acting on multiple bacterial targets while simultaneously reducing the effective dose of individual drugs.The use of combination antimicrobials to prevent emergence of resistance and improve patient outcomes is standard practice in the treatment of tuberculosis, H. pylori, HIV, and currently malaria.The development of new antibacterial agents typically focuses on primary efficacy and the generation of resistance has not been a major consideration. This approach carries a legacy of failure with widespread resistance to almost all available agents.The purpose of this FOA is to investigate the potential value of novel PK/PD-based dosing and combination therapy approaches in preventing the development of antimicrobial resistance.[4] New modeling systems, such as in vitro hollow fiber systems, may be helpful in clarifying the potential value of these approaches. Areas of primary concern are Gram-negative pathogens that are frequent in health care settings as well as in the community, and are commonly treated with single agents, e.g. pathogens responsible for uncomplicated urinary tract infections. Many of these organisms, including E. coli, K. pneumoniae, Serratia, Acinetobacter, Proteus, P. aeruginosa, and Enterobacter spp., exhibit growing resistance to multiple antimicrobial agents.
Federal Grant Title: Advancing Regulatory Science Through Development of Innovative Methodologies in the area of Antimicrobial Development (U01)
Federal Agency Name: Food and Drug Administration
Grant Categories: Health Science and Technology
Type of Opportunity: Discretionary
Funding Opportunity Number: RFA-FD-11-026
Type of Funding: Cooperative Agreement
CFDA Numbers: 93.103
CFDA Descriptions: Food and Drug Administration_Research
Current Application Deadline: Jul 02, 2011
Original Application Deadline: Jul 02, 2011
Posted Date: May 23, 2011
Creation Date: May 25, 2011
Archive Date: Aug 01, 2011
Total Program Funding: $500,000
Maximum Federal Grant Award: $100,000
Minimum Federal Grant Award: $50,000
Expected Number of Awards: 6
Cost Sharing or Matching: No
Applicants Eligible for this Grant
Public and State controlled institutions of higher education - Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education - Private institutions of higher education - Others (see text field entitled "Additional Information on Eligibility" for clarification)
Additional Information on Eligibility
Higher Education institutions as defined in section 101 of the Higher Education Act of 1965 (or a consortium of such institutions). Nonprofits Other Than Institutions of Higher Education - A nonprofit organization described in section 501(c)(3) of the Internal Revenue Code of 1986 which is exempt from tax under section 501(a) of that code. An eligible organization that wishes to enter into a colaborative agreement must provide an assurance that the entity will not accept funding for a Critical Path Public-Private Partnership project from any organization that manufactures or distributes products regulated by the Food and Drug Administration unless the entity provides assurance in its agreement with the FDA that the results of the Critical Path Public Partnership project will not be influenced by any source of funding. The entities eligible to enter into partnerships with FDA are governed by Section 566 of the FD&C Act (21 U.S.C. 360bbb-5).
Link to Full Grant Announcement
Information not provided
Grant Announcement Contact
Gladys Melendez Grants Management Specialist Phone 301-827-7168

FDA office email [gmbohler@fda.hhs.gov]
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