Sole Source Fixed Price Contract for the procurement of “Pharmacy Supplies”-to be Sole Sourced to Program Support Center. , under Request for Quote FDA-RFQ-2021-1238225

Closed Pre-Solicitation Posted

Solicitation number
FDA-RFQ-2021-1238225
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

NAICS code
446199 All Other Health and Personal Care Stores
PSC
6515 Medical And Surgical Instruments, Equipment, And Supplies
Place of performance
Silver Spring MD 20993 USA

Notice details come from SAM.gov. Updated .

Notice text

FDA has a requirement to procure “Pharmacy Supplies”-to be Sole Sourced to the Program Support Center., under Request for Quote FDA-RFQ-2021-1238225. The Division of Applied Regulatory Science (DARS) OCP/OTS/CDER is evaluating in vitro and in vivo pharmacokinetic assessment of biosimilarity and evaluating models of toxicity assessment for new drug classes. As part of this process DARS needs to acquire these pharmacy drugs to evaluate their parameters:

i.  Peg-interferon beta - (Plegridy, 125ug syringe, pk of 2 pens); NDC/NSN = 64406-011-01

ii.  Interferon beta - (Avonex, 4 - 30ug pre-filled syringes); NDC/NSN = 59627-333-04

iii. Pegloticase (Krystexxa, 8 mg/ml, 1ml vial); NDC/NSN = 75987-080-10

iv. Alirocumab (Praluent, 75 mg/ml, 1ml syringe); NDC/NSN = 0024-5901-01

v. Reslizumab (Cinqair, 10 mg/ml, 10ml vial); NDC/NSN = 59310-610-31.

See attached notice,

Files

File Type Posted
Notice of Intent to Sole Source.doc DOC document

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