RFQ_FDA-SOL-13-1119904_QandA.doc

RFQ FDA-SOL-13-1119904 Genomic Information Management System Questions and Answers

1. Are barcode scanners and barcode printers government furnished property?

ANSWER

Yes. The solicitation has been modified in Section 4 “Government Furnished Property” to include barcode scanners and barcode printers.

2. Are bidders required to fill out all the forms of FAR provision 52.212-3?

ANSWER:

Refer to the first paragraph of the provision for instructions on which sections of the provision are must be completed and how.

3. Does the Buy American Act apply to this acquisition?

ANSWER:

No, as this acquisition is for information technology that is a commercial item. See FAR 25.103 (e).

4. May vendor receive a copy of the FDA’s MAT list?

ANSWER:

No.

5. In the ‘Schedule of Pricing’, it lists quantity 2 of GIMS Sequencer Connection. However, there are 3 sequencer platforms described (Requirements 4.1.2) for the GIMS being able to interface (Illumina MiSeq, PacBio GS, and LifeTech Ion Torrent). Is this a misprint, or do we assume 1 would be for the Illumina MiSeq and 1 for the Life Tech Ion torrent? Please clarify.

ANSWER: GIMS must be able to interface with 3 sequencer platforms (Illumina MiSeq, PacBio RS II, and Life Technologies Ion Torrent) even though only 1 type of connections will be stood up at purchase. Two Illumina MiSeq instruments are directly connected to the FDA network and GIMS must be able to interface with these systems. The PacBio and Ion Torrent sequencers are not directly connected to the FDA network and would not interact directly with GIMS. If, in the future, these platforms can be brought into compliance with FDA IT standards then they would need to interface with GIMS.

6. For requirement 4.1.3, in order to collect ‘data from various instruments used in the preparation and QC steps preceding the sequencing instruments’, a description of the specific data fields is required. For example the Agilent BioAnalyzer outputs 3 files at minimum on certain runs each with different formats. Question: Will the GIMS be needed to ingest these files and serve their contents to the user interface? Some are flat values (e.g. 260/680 ratios) some are images (e.g. gel spread with size standards/ladders)

ANSWER: GIMS should be able to ingest selected fields and values from flat/text output files. GIMS should also be able to record links to images but would not be required to store the images themselves.

7. For requirement 4.1.3, will users manually uploading the QA instrument files (e.g. by transferring from removable flash drives) to the GIMS meet acceptance criteria or is the client expecting an automated ingest of QA/QC instrument output files from a secure intranet connection? Compliance officers tend to restrict removable flash drives unless they are encrypted, however, some Agilent BioAnalyzers do not have an Ethernet jack for direct data transfer and storage.

ANSWER: GIMS needs to be able to receive QA input either via network connected instruments, secure intranet connection to shared drives, or secure/hardened workstations connected to the FDA network. In this case the BioAnalyzer would be connected to a hardened scientific workstation and the QA files would either be copied using secure flash drives or to intranet shares.

8. For requirement 4.1.4., the simplest and least expensive method (‘to initiate preliminary analysis when runs are completed’) is executing scripts upon the production of expected files upon run completion. Will the compute environment’s security and Chief Information Security Officer permit shell/system scripts to run and monitor for files produced? Otherwise, the GIMS will need to be running at all times the sequencers are running.

ANSWER: Yes, shell/system scripts will be permitted to run on the GIMS. The scripts will be subject to review by FDA IT security prior to installation.