Responses to Questions.doc

Responses to Questions

1. For the delivery of the classroom training, is this to be delivered by 1 or 2 trainers?

Response: It is up to the offeror to propose a plan and approach for delivering the classroom training to most effectively meet the requirements described in the Scope of Work. This approach should be based on the offeror’s understanding of the requirement and experience in delivering similar training activities.

2. For the delivery of the classroom training, are all of the reviewers going to be local to the training?

- That is to say, there will be no remote reviewers during the classroom training sessions connected through Webex or video-conferencing.

Response: Reviewers who participate in classroom training will be local; we do not plan on having classroom sessions connected through Webex or video conferencing.

3. Will the classroom training be therapeutic-area specific or more general in nature?

Response: Classroom training will be general in nature; however, there may be therapeutic-area specific questions asked by participants during the training sessions.

4. Would FDA consider re-evaluating the modules to be offered, either consolidating the modules or augmenting the offering to provide more time for some of the sessions?

Response: We believe the modules we have described in the Scope of Work will meet our initial training needs. We can consider re-evaluating or augmenting these modules during the option year.

5. Is it the desire of the FDA to video the classroom training sessions to offer as part of the "Web-Based" training?

Response: Yes.

6. Who owns the training materials that will be developed based on this proposal?

Response: FDA/CDER will own the training materials developed during the course of this project.

7. Is there a period of ownership that expires after a certain amount of time?

Response: No, per FAR 27.404, the Government acquires unlimited rights to data first produced in the performance of this contract.

8. Is there a requirement to use CDISC copyrighted training materials?

Response: No, there is not.

9. Once developed – what are the requirements for keeping both classroom and web-based training materials updated?

Response: Maintenance for keeping the materials developed during this project is not a requirement in this scope of work—updating these materials may be addressed in the scope of work for the option year. It is desirable that the classroom training modules be flexible enough to address changes in the approved SDTM version (e.g., from SDTM 3.1.1 to 3.1.2) that occur during the course of the contract period of performance.

10. Given that the web-based training will be published on the QSPG web-site - what are the technology requirements and are they published?

Response: Web-based materials must be compliant with Section 508 of the Rehabilitation Act of 1973, which is designed to provide access to and use of Federal executive agencies’ electronic information technology by individuals with disabilities. More detailed information on Section 508 can be found at the following web site:

http://www.section508.gov/index.cfm?FuseAction=content&ID=12

11. Does FDA have a LMS that the web-based training will be loaded into?

Response: No we do not.

12. If FDA has a LMS, which vendor provides it and who will be responsible for loading of the web-based course materials into it?

Response: See #11 above.

13. Is there a requirement to track all usage of the web-based training?

Response: No

14. Are assessments (testing) required to be built into the web-based training?

Response: The Statement of Work does not mention assessments explicitly, but assessments/testing would be a useful way to evaluate the usefulness/effectiveness of the web-based training.

15. How was each labor category and hours required determined?

Response: Labor categories and hours were determined based on market research and FDA’s previous experience with similar training contracts. However, offerors may propose alternate labor categories and hours. Additionally, as positional title and job titles vary among vendors, proposed labor categories must be supported by detailed descriptions to allow for a relative comparison to the work requirements in the PWS.

16. Are expenses to be included in the price estimates?

Response: Yes. There is no separate reimbursement for Other Direct Costs. Your prices should be inclusive of all costs.

17. Is there a requirement to have a GSA schedule available?

Response: No

18. Will award of the RFP be split between multiple vendors?

Response: No