RFI Q A.pdf

ICATT Pharmacy Services RFI Ques ons and Answers

1. As it relates to vaccina ons, is this only meant to include COVID‐19 vaccina ons or are other vaccina ons, like seasonal flu, also included?

Answer: Vaccina ons should include ACIP recommended vaccines.

2. As it relates to therapeu cs, is this meant to cover the cost of the medica on used for treatment and if so, is that inclusive of ONLY covid‐19 treatment ( e.g. paxlovid) or would also include flu treatment, and subsequent medica ons (e.g. oseltamivir).

Answer The RFI is not asking for cost, only the capabili es to provide the services. Capabili es to administer other therapeu c treatment should be considered in the response to the RFI.

3. Regarding the provision of tes ng, therapeu cs, vaccines, and sample collec on and forwarding, what disease(s) / disease states are in scope?

Answer: For tes ng, vaccines, and therapeu cs

This is for the acquisi on of disease agnos c services, where services have FDA EUA approval or full FDA approval. To clarify, not all test listed are mandatory. CDC is seeking a list of current and possible future capabili es.

The government is interested in contractors capable of providing a selec on of the following tests na onwide. While not all tests listed below are mandatory, the Contractor is encouraged to provide a broad mix of tests and sites to ensure resource and test manufacturing limita ons do not impact contract performance.

Laboratory‐based tes ng o Nucleic Acid Amplifica on Test (NAAT) tes ng

Single Plex tes ng Mul plex tes ng Sequen al Mul plex tes ng o Blood spot tes ng Dried Wet o Specialized tes ng Urine Blood Specialized Respiratory Samples Other bodily fluid sample types as needed o Point‐of‐Care (POC) NAAT tes ng Single Plex tes ng Mul plex tes ng o Point‐of‐Care (POC) An gen tes ng Single Plex tes ng Mul plex tes ng o Over the counter (OTC) test distribu on (government provided) o Sequencing (Diagnos c or Confirmatory) o Pooled Sample Tes ng

TASK E: Sample Collec on and Forwarding The program objec ves will be achieved through the Contractor's obliga ons to collect, handle, and forward biological samples for diagnos c purposes as per Government direc ves.

Types of Collec on could include but are not limited to collec on by trained personnel, observed self‐ collec on, and unobserved self‐collec on samples listed below.

*Examples are provided for reference only but do not limit the use of sample type.

Respiratory Swab (COVID‐19 An gen, Flu A&B) Conjunc val swab (Chlamydia) Respiratory specimen (Tuberculosis) Throat swab (Group A Strep) Blood Sample (Cholesterol, HIV, Hepa s C, STD) MonoSpot blood test (Mononucleosis) FingerS ck (A1C, Glucose) Urinalysis (UTI, STD) Skin Lesion material (Mpox) Saliva (COVID‐19)

The Contractor shall submit specific specimens for further characteriza on (e.g., genomic sequencing, culture) to state or federal laboratories, or affiliated laboratories, as iden fied by the Government.

For capabili es not currently available or not possible:

Page 5, Ques on 2 When considering the proposed tasks in the Core Services, what challenges do you foresee in fulfilling the listed requirements?

Are all the ac vi es in Task A currently available? And if not, which ones are not available?

If Task A capabili es are not available, could any be available under a sub‐ contractor rela onship? Which ones?

If offered, would a phased‐in approach support future implementa on of capabili es not currently available? Which capabili es would this apply to.