Questions and Answers for the Capacity Building requirement.doc

Questions and Answers for the Capacity Building Requirement

1. Can you provide the locations of your international program offices for our planning considerations. Attached is an organizational diagram we pulled from the FDA, OIP site that outlines 8 offices under the Office of International Programs.

Answer: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm185769.htm

2. If we are selected as the contractor performing the analysis effort under this solicitation, will we be precluded from performing work under existing or future FDA contracts to support the identified FDA training needs per the Organizational Conflict of Interest clause, or will the results of this analysis be released to public, thus allowing us compete for potential follow-up implementation efforts. What current and future FDA contracts would be used to implement the solutions to meet any training gaps from this analysis?

Answer: Current and future contracts would depend on budget allocations and strategic directions. There are as yet no established or determined contracts.

3. Can we obtain a more inclusive list of submission requirements? (i.e. number of pages required, format font, page size, fold outs, margin requirements, orientation, table and figurers etc).

Answer: There are no stated formatting requirements for this solicitation.

4. Is there an expected number of training suppliers / courses anticipated to be included in the database? Or is there an anticipated range of suppliers / courses, e.g., 150-200, 200-250, 250-300?

Answer: No. The contract indicates this should be a comprehensive assessment.

5. Is there an expected number of reference checks to be performed for each training supplier / and or course? Or is the number of references to be checked at the discretion of the contractor, based upon research methods?

Answer: The reference checks are at the discretion of the contractor.

6. How many people will require training at the FDA on the use of the Database?

Answer: Approximately 25

7. Is there an existing database, or does this information exist in some part and / or form at the FDA?

Answer: No, there is some dispersed information about training activities but it is not consolidated, hence the specification in the contract to develop and populate the database.

8. Will For-Profit organizations that provide training on GCPs, GMPs, etc., be included in the database?

Answer: Yes, the database should include for-profit and industry training providers.

9. Are proposals due on August 2nd or August 6th (says aug. 2 in section A and aug. 6 in section L)?

Answer: August 6, 2010.

10. Who is the incumbent contractor performing these services? Or is this a completely new requirement?

Answer: No one. This is a new requirement.