Attachment No. 6 - Answer & Questions.docx

Attachment No : 6 Questions & Answers Solicitation No : FDA-22-SOL-1240447 – Amendment No : 2

1.

Question: Manures, Composts and Soils -- What type of testing and Sampling frequency? Suspect rate data if any?

Government Response

(For Government use only) Could be any major foodborne pathogens such as Salmonella, STEC, listeria, etc. depending on FDA need at a specific time. If FDA start a project, sampling schedule will be determined at that time.

Question: CBD, --- Legal clearance needed ? What type of testing and frequency ?

Government Response

(For Government use only) This will be dealt with following related regulations. Most likely it will be done in the states easier to handle. Tests Could be any major foodborne pathogens such as Salmonella, STEC, listeria, etc. depending on FDA need at a specific time. If FDA start a project, sampling schedule will be determined at that time.

Question: Cosmetics: What are the FDA expectations regarding cosmetic products and method validation? Rapid methods we run do not have any validation to cover these types of products. Would the FDA want cultural methods to be run?

Government Response

(For Government use only) BAM or other equivalent validated methods should be followed if we conduct any cosmetics project. If no method available, FDA will decide a method in consultation with the contractor.

Question: Cosmetics : Organsims and Method references ? The document mentions Pseudmonas aeruginosa, Staphylococcus aureus, Burkholderia cepacia, Enterobacter spp., and Aspergillus spp under 1.1. That said FDA BAM chapter 23 has a lot more . Clarity on the method references and alternatives will be helpful.

Government Response

(For Government use only) For any test there is no official methods available, FDA will specify the method to be used when designing the project, in consultation with the contractor.

Question: Agricultural waters: Are methods other than EPA acceptable, i.e. standard methods for the examination of waste water?

Government Response

(For Government use only) We listed many methods in the solicitation. We will consider other equivalent methods with solid support data considering the special condition if we need a project for agr water.

Question: COVID-19 in Objective - is this for SARS-CoV-2 RNA detection in environmental surfaces?

Government Response

(For Government use only) Not limited to environmental surfaces

Question: For Norovirus and HepA, we are following ISO 15216-2 currently where the extraction differs from FDA BAM Ch 26B. Is it acceptable to follow the ISO method as written?

Government Response

(For Government use only) ISO is acceptable.

Question: Vibrio spp, does this include all organisms or just certain species of concern, i.e. cholerae and parahaemolyticus?

Government Response

(For Government use only) All depend on FDA need in the next few years. But highly unlikely all the species.

Question: Shigella pcr, will Hygiena rapid assay be acceptable? This method references their internal validation study but not FDA, AOAC, etc.

Government Response

(For Government use only) As the solicitation stated, validated methods in comparison with official reference methods.

Question: WGS: Recognizing that sequencing technology rapidly changes, is it expected that the FDA task order will accept data generated using Illumina sequencing platforms? In other words, is there an expectation for long read sequencing data?

Government Response

(For Government use only) This is a rapidly changing field as you just said. We accept Illumina method now. Others are possible with FDA written permission.

Question: WGS: Can links to current GenomeTrakr SOPs be provided (to review methods) since we do not currently have access to NGS RedMine?

Government Response

(For Government use only) See https://www.protocols.io/workspaces/genometrakr1/publications

Question: Do all methods need to be on ISO scope

Government Response

(For Government use only) The solicitation listed numerous analytical methods, including ISO.

Question: Cryptosporidium: Is microscopy a requirement?

Government Response

(For Government use only) Follow the current FDA BAM method.

Question: Cryptosporidium: There are no Cryptosporidium methods with AOAC OMA approval and appear to be limited commercial options. Can FDA share any information about acceptable alternatives for Cryptosporidum detection?

Government Response

(For Government use only) See BAM Chapter 19a, 19b, 19c.

Question: Cyclospora, Cryptosporidium, SARS-CoV-2 RNA, WGS and HepA are missing from the task orders. Please confirm need for collection and analysis for these analytes/methods (plus volume).

Government Response

(For Government use only) The solicitation does not include task orders. Depending on FDA need, task orders will be developed after signing contract. For any test there is no official methods available, FDA will specify the method to be used when designing the project.

Collecting samples will be an essential part of work for many projects.

Question: Pathogen enumeration is best done via MPN methods, can we quote MPN for these tests?

Government Response

(For Government use only) Yes. That’s good.

Question: Under Norovirus and Hep A method - there is reference about "RNA Template Controls and Stool Samples", need clarity the stool samples part.

Government Response

(For Government use only) Details will be worked out by FDA if we ever need a Norovirus or Hep A project. This solicitation is just a general statement about possible works in the next few years.

Question: We are hoping to find out if there is (was) an incumbent contractor performing these services, or if this is a brand new contract. If there is an incumbent, could you please provide the current / previous contract number?

Government Response

(For Government use only) The incumbent is “Molecular Epidemiology Inc” and Contract No: HHSF223201810028I.

Question: We would greatly appreciate it if you would consider extending the submission deadline for two weeks as we prepare a detailed response to the solicitation. In the past, we’ve had much longer time to prepare, but only less than a month this time, making it difficult to gather all of the required information.

Government Response

(For Government use only) We will extent the closing date for additional two (2) weeks. The Amendment No: 2 will show new closing date/time.

End of Questions & Answers.