Final_Q A_for_Question_22.doc

Final Questions and Answers Regarding Question# 22 **Please Note: Offerors are not required to provide pricing for Indefinite Delivery Indefinite Quantity (IDIQ) services found in Section 4.9 of the RFP, except for the Additional Ad-Hoc Hours in increments of 100 Hours NTE 4000, as described in the IDIQ Section of Attachment 2- Pricing.** Further Response to Question #22: Question #22 was only partially answered by FDA. We believe no offeror will be able to price the use of the data by three (3) outside DHHS agencies without a complete explanation of:

1. The number of users within each agency:

Answer: One

2. Definition of the specific limitation on these agencies’ use of the data and services provided:

Services will be for a limited number of specific categories of drugs. Clearance requests will be limited to 30 requests. Ad hoc programming hours will be limited to 30 hours.

3. A methodology/process the FDA will follow for the other agencies’ use and disclosure of the data and services:

Answer: The agencies will submit data clearance requests to the FDA. The agencies will complete and submit the clearance form and appropriate documentation to the FDA stating how and when the data will be used for FDA to send to the vendor.

4. Defined therapeutic areas:

Answer: Possible limited therapeutic areas of interest are Pain, ADHD, anti-anxiety medications, analgesics, seizure medication, cough and cold products, and anti-depressants, etc. This list is not all inclusive nor will all agencies require access to all the same therapeutic areas of interest.

5. Documented assurances that these other users would be bound by the terms of the license agreement (e.g., license grant, confidentiality, license restrictions):

Answer: 1) Sign a Third Party Agreement directly with the contractor with terms of agreement (optional – at contractor’s discretion) 2) Contract modification for the IDIQ services (required) 3) an Intra-Agency Agreement with the terms of the agreement with the FDA (required).