Source Sought Notice.pdf
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- Attached to
- Active Pharmaceutical Ingredients’ (API) Manufacturer Data Acquisition Federal contract opportunity
- Solicitation number
- FDA-SSN-1227066
About this file
This sources sought notice seeks active pharmaceutical ingredients manufacturing facility and product data. The Food and Drug Administration's Center for Drug Evaluation and Research requires a contractor to provide data including API manufacturer details, manufacturing facilities, products manufactured, and regulatory information. 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 period of performance would be one year from date of award.
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Text version
General Information:
Document Type: Sources Sought (FDA-SSN-1227066)
Release Date: August 21, 2020
Response Date: August 27, 2020 at 3.00 P.M. EST via e-mail to Ravichandan.Palaniandy@fda.hhs.gov
Contract Information: Ravi Chandan Palaniandy
Contract Specialist
Office of Acquisition and Grants Services
U.S. Food and Drug Administration
Tel: 301-796-4378
Email: Ravichandan.Palaniandy@fda.hhs.gov
Description: Active Pharmaceutical Ingredients (API) Manufacturer Data
Acquisition
This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition, 541910, Market Research and Public Opinion Polling
($15 million).
Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice.
**QUESTIONS WILL NOT BE ENTERTAINED AS A RESULT OF THIS NOTICE**
Background
Source
To that end, CDER would like to obtain worldwide 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.
mailto:Ravichandan.Palaniandy@fda.hhs.gov
Objectives
The objective of this effort is for CDER Procure API Manufacturing facility and product data that will be used in program analysis.
Scope of Work
The source needs to provide the Food and Drug Administration (FDA)/Center for Drug
Evaluation & Research (CDER) with the following:
Contractor shall provide API data that will be tailored to contain the following information:
• Relationships with other drug manufacturers and Sponsors
• Regulator standing abroad and domestically
• Presence of Drug Master File (DMF) licenses
• The facility is producing or is capable of producing commercial quantities of the
API
• The site is in the developmental process, and has the capacity to manufacture the
API
• Facility is currently not manufacturing this API, but had at some time in the past manufactured this API
• API Manufacturer Company Name
• API Manufacturer Company Street Address
• API Manufacturer Company City
• API Manufacturer Company Country
• API Manufacturer Unique numeric identifier, referred to as a “DUNS”
(Data Universal Numbering System) Number.
• API Manufacturer FEI Number (if available)
• API Manufacturer Latest FDA Inspection Date (if available)
• API Manufacturer Corporate Group Name
• API Manufacturer Corporate Group Country
• Names of all API’s manufactured at the facility
• API Unique Ingredient Identifier (UNII) code
• Manufacturing Status (example: “Not Manufacturing”, “Early”, “Innovator/Marketer”, “Under Development”, or “Commercially Available”)
• Active US Drug Master File (“Yes” or “No”)
Contractor shall provide quarterly progress reports on the accomplishment of specific activities each month and various stages of work in progress.
Period of Performance
The period of performance is one (1) year period form date of award.
Capabilities and Technical Experience:
Provide a capability statement describing how your company would meet the requirements.
Business Status:
Please provide your business size status (e.g., small business, 8(a), HUBZone, etc) and
DUNS number.
Disclaimer and Important Notes:
This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work.
Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.
Responses to the sources sought shall be no longer than 10 pages.
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