Active Pharmaceutical Ingredients’ (API) Manufacturer Data Acquisition
Closed Pre-Solicitation Posted
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- Solicitation number
- FDA-SSN-1227066
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- Total Small Business
Opportunity facts
- NAICS code
- 541910 Marketing Research and Public Opinion Polling
- Place of performance
- Silver Spring MD 20903 USA
Notice details come from SAM.gov. Updated .
About this opportunity
This pre-solicitation notice seeks to procure active pharmaceutical ingredients manufacturing facility and product data from contractors. The Food and Drug Administration's Center for Drug Evaluation and Research requires this data to assist with programs relying on manufacturing information for compliance, surveillance, enforcement, drug shortages, and user fee collections. Responses are requested by August 27, 2020 to assist the agency in determining an appropriate acquisition strategy, including the possibility of a small business set-aside.
The opportunity is set aside as a total small business procurement. The NAICS code is 325412, Pharmaceutical Preparation Manufacturing, and the PSC code is R699, Other Professional, Administrative and Management Support Services. The period of performance is one year from date of award. The data required includes details on API manufacturers, manufacturing facilities, products manufactured, and regulatory information. This information will help the FDA with various programs that rely on drug manufacturing data.
Notice text
To obtain API manufacturing facility and product data that can assist CDER in programs that rely on manufacturing information for the purposes of compliance, surveillance, enforcement, drug shortages and user fee collections.
See enclosed Sources Sought Notice for full detail of requirement.
Files
| File | Type | Posted |
|---|---|---|
| Source Sought Notice.pdf |
Notice history
| Notice | Type | Posted |
|---|---|---|
| Preventative Maintenance Agreement (PMA) to cover and LC-Orbitrap Mass Spectrometer System, for a base year (12 Months), Plus, four (4) option years. | Solicitation | |
| Nanostring Cassettes and Associated Reagents | Pre-Solicitation | |
| This notice | Pre-Solicitation |
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