SOLICITATION NOTICE
68 -- Atropine Auto-Injector
- Notice Date
- 8/23/2016
- Notice Type
- Presolicitation
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 2016-Q-65994
- Archive Date
- 9/17/2016
- Point of Contact
- David M. Kelley, Phone: 7704882662
- E-Mail Address
-
vrb7@cdc.gov
(vrb7@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- NOTICE OF INTENET TO SOLE SOURCE: The Centers for Disease Control and Prevention (CDC) intends to award a sole source firm fixed price contract to Rafa Laboratories, Ltd.. The Government intends to purchase 3,707,574 doses of Food And Drug Administration (FDA) licensed Atropine sulfate auto-injectors by September 30, 2021; 1,107,996 by January 1, 2017, with a period of performance of 5 years from date of award. Rafa Laboratories is the only vendor that has begun submission of the pre-NDA/ANDA fillings (Atropine sulfate 0.5 mg, 1 mg, 2 mg) with the FDA and an Emergency Use Authorization (EUA) from the FDA for this product manufactured by Rafa is currently being processed/approved. Rafa is the only vendor that currently manufacturers this product, can obtain expedited FDA approval, and produce and deliver the quantity required. The Government intends to negotiate this requirement under the authority of FAR 6.302-1. It is the Government's belief that only one responsible source exists and no other product or services will satisfy agency requirements. This notice of intent is not a request for competitive proposals. A determination to compete this procurement based on a response to this notice is solely within the discretion of the Government. Interested parties who believe they possess the capabilities to satisfy this requirement should submit a capability statement demonstrating their abilities to meet this requirement. All responses must be received by September 2, 2016 at 1200 EDT. All responses must be in writing and can be sent via email to vrb7@cdc.gov. No phone calls will be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/2016-Q-65994/listing.html)
- Place of Performance
- Address: 1600 Clifton Road, Atlanta, Georgia, 30341, United States
- Zip Code: 30341
- Zip Code: 30341
- Record
- SN04237455-W 20160825/160823235818-5b3fb7aed068ad0ad11150e83fa51190 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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