Topical Microbicides Safety and Efficacy Application Process

Application and Approval Process

Step 1—Discuss the potential request informally with the program officer

Investigators with a promising topical microbicide and/or barrier device should contact the project officer and complete a Request for Access form. Products may be in the early stage of formulation. Your request will be considered vis a vis the standard criteria listed below.

1. Proposed studies within the DMID/NIAID mission
2. Proposed studies within the scope of and/or technology provided by awarded contracts
3. Sufficient quality and/or quantity of product available
4. Proposed studies in compliance with animal welfare regulations
5. Proposed work not supported by other funding sources/available from other sources
6. Previous use of DMID resources for assessment of the same or similar product (Repeat use of DMID resources may be undertaken with strong justification.)
7. Preliminary data adequate to support the request to advance the product to the next step in the product development pipeline
8. Likelihood that services will contribute significantly to the eventual development and/or evaluation of a product of high quality
9. Purported public health impact
10. Improvements in health benefits offered beyond current measure(s)
11. Availability of a plan for advancing the product beyond completion of the services requested

Step 2—Applications will be prioritized by a joint committee of staff from the Division of Microbiology and Infectious Diseases and the Division of AIDS according to the standard criteria noted above.

Preliminary data is considered in the decision making process. Requests supported by preliminary initial safety testing data, such as in vitro cellular safety testing and /or toxicity testing in one small animal model toxicity testing, such as the rabbit vaginal irritation test, may be authorized for further safety testing and may be followed by efficacy testing.