FDA-RFP-1209563_Q&A.pdf

FDA-RFP-1209563

Q&A

QUESTIONS AND ANSWERS

The following are the questions submitted prior to receipt of proposals and their corresponding answers.

Question 1: We have the following questions:

a. Page 16 of 44, please explain the paragraph below:

“The offeror shall submit a written Accessibility Conformance Report (ACR) addressing the level of conformance of the delivered items to the 508 standards identified in clause 352.239-74. The ACR should be based on the Voluntary Product Accessibility Template Version 2.0 (MS Word) provided by the Industry Technology Industry Council (ITIC). To be considered for award, the ACR must be complete, and submitted according to the instructions provided by ITIC.”

b. “NOTE: Submission of the ACR is required for documentation purposes. In accordance with agency purchasing procedures, solutions which do not conform fully to the applicable 508 standards may still be purchased by FDA if the FDA Requiring Office obtains the appropriate approval. In order to obtain approval, the FDA must have an ACR from the vendor documenting the level of conformance of the items being purchased.

Offerors shall submit the following information for MAT List approval:

• Version/Model number of the proposed software.

• Description of what your software does (if the software contains a suite of products, please provide the function of each product contained within the suite.

• Website URL for Software”

Answer 1a: Go to the ITIC website via the link to find out how to meet this requirement.

Answer 1b: In order for the FDA to have your software approved for use, the IT/systems folks will need to approve it and need to know the information requested.

Question 2: Page 13 -44: On section 7: Deliveries, acceptance and performance dates. To my understanding we are sending the response of the RFP via email (all three parts). Do we need to also send a hard copy? Please confirm this.

Answer 2:You do not need to send a hard copy. The solicitation specifically states to send via email.

Question 3: In the section 6.6 Pathology Requirements: “Please clarify item (d) ‘Allow input of study specific Tissue List Driver’.”

Answer 3: The system must have the ability to allow the user to put in study specific requirements, including tissues and how the tissues will be handled (fixed, frozen, etc.).

Question 4: I see that the RFP includes a requirement for 75 concurrent users but would like to know the expected number of active named users who will use the system at the NCTR facility. Further, if you can separate the user count into two numbers: a) number of users requiring full access and b) number of users requiring read-only access.

Answer 4: 150 unique named users will be needed once the system is validated and tested. Only 75 users will be using the system at one time. These numbers may vary due to the difference in functionality between the new software and current software. Out of the 150 we feel that only around 50 (25 concurrent) users would need full access and 100 (50 concurrent) would need read only. Again, these numbers are hypothetical.

Question 5: In Section 6.1 IT Requirements, the requirement “n. Have the capacity to support at least 75 concurrent users” is stated. How many users (individuals) will require access to the system? I.E. how many users will need to be registered into the security module to allow them access to the system?

Answer 5: 150 individuals may have their name listed, but only around 75 concurrent users will be using the system at any one time.

FDA-RFP-1209563

Q&A

Question 6: In Section 6.1 IT Requirements, the government sates that it will supply the server hardware and third-party software licenses (oracle, operating system, etc.), and yet in section 6.7 (e) the requirement is for a ‘Turn key’ system where the contractor supplies all hardware and software. Which one is correct?

Answer 6: The government will provide the infrastructure on which the software will run. This includes the servers, network, operating systems and database. The “turn key” expectation is that the software can be configured and will run in the environment without the need for additional programming and/or compiling or the purchase of third-party software.

Question 7: In Section 6.5 Data Collection Requirements (i) “Be able to collect veterinary observations and treatments from physical and ophthalmic exams. This includes type and amount of medication administered as well as the timeframe for treatments”.

a. Does this apply to animals both on study and off study?

b. Are the vet exams considered part of the study data?

Answer 7a: This software is limited to study data and study treatments. We have other mechanisms to capture exams and treatments that are not study driven.

Answer 7b: This is study specific – the vet exams will be considered a part of some studies and not others.

(End of Q&A)