Notice of Intent to Sole Source.doc

Food and Drug Administration (FDA)

Notice of Intent to Sole Source

Subject: 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.

Notice of Intent to Sole Source to: Program Support Center.

Pursuant to the authority of 41 USC 3304(a)(1), as implemented by Federal Acquisition Regulation (FAR) Subpart 6.302-1, (there is only one responsible source and no other supplies or services will satisfy agency requirements). The Food and Drug Administration (FDA) intends to award a Sole Source firm-fixed price purchase order to Program Support Center located at:

U.S. Department of Health and Human Services

Building #14

Perry Point, MD 21902

Office: (410) 642‐2244

Fax: (410) 642‐2047

Contact: Trisha Futty

Supervisory Management Analyst, Supply Chain Management Services

Office: (410) 642‐2244

Mobile: (202) 657‐9025

Email: Trisha.Miller@psc.hhs.gov FDA has a requirement to procure “Pharmacy Supplies”-to be Sole Sourced to Program Support Center., under Request for Quote FDA-RFQ-2021-1238225. he 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 These drugs are not available from any other vendor at government contract pricing.

Similar contracts were awarded in 2017 (requisition, 1185485, on 07/20/2017, award number HHSF223201710250P) and 2018 (requisition, 1202722, on 06/25/2018, award number HHSF223201810324P) and 2019 (requisition, 1213677 on 7/18/19, order number 75F40119P10345). The Contractor was DHHS PROGRAM SUPPORT CENTER 999403. Other vendors sell these drugs at retail or slightly discounted prices; however, the only vendor found that will offer the FDA discounted, government pricing is purchasing through the Program Support Center, U.S. Department of Health and Human Services.

The NAICS code: 446199 Medical equipment and supplies stores This notice is not a request for competitive proposals. However, any party that believes it is capable of meeting this requirement as stated herein may submit a written capability statement that clearly supports and demonstrates their ability to perform the requirement. Capability statements must be received by the response date and time of this notice. Submissions will be reviewed to determine if they can meet the requirement. A determination by the Government to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government.

It is anticipated that an award will be issued to Program Support Center, within approximately fifteen (15) days after the date of this notice unless the Government determines that any other organization has the capacity to meet this requirement.

Response Date: 12:00 p.m. EST 02/05/2021. Please email responses to Emmanuel Mbah at Emmanuel.mbah@fda.hhs.gov Template