PUBLIC NOTICE OF PROPOSED ACQUISITION
National Eye Institute / National Institute of Health
Announcement/Number: EE21-005569
Post Date: August 04, 2021
Closing Response Date: August 14, 2021
Proposed Award Date: August 16, 2021
Project Title: Transport Container Sterilization Services
Contracting Office: National Eye Institute, Building 31, Room 6A52
Contact Point/Contracting Officer/Contract Specialist: Elaine Estrella, estrellaek@mail.nih.gov
North American Classification System (NAICS) Code (include): 541990
Classification Code: All Other Professional, Scientific, and Technical Services
BACKGROUND AND PURPOSE:
The NEI is developing a phase I Investigational New Drugs (IND) using autologous induced pluripotent stem cells (iPSC) derived Retinal Pigment Epithelium (RPE) sheets as cell therapy for advanced Age-related Macular Degeneration (AMD) patients. This part of the project requires testing if the cells in the product manufactured has any oncogenic mutations. Results from these studies is required to support an IND filing for a phase 1 clinical study in humans. The purpose of this project is to validate the sterilization process of the transport containers which will be used to transport the clinical product.
REQUIREMENT:
Description
- Generic Run Radiation
- RAD-Single Dose Map 1-run
- RAD-validation & Batch Release (includes protocol, final report, general consulting and project management).
- Bioburden (aerobes and Fungl)
- Bioburden Recovery
- Product Sterility
- Sample Preparation
- Cleanroom Fees
- Method Suitability Testing
- Organism ID – Genetic ID
PAYMENT
Payment will be made 30 days after internal receiving in NIH system.
AWARD TYPE
Firm Fixed
DELIVERY
NATIONAL EYE INSTITUTE/ NIH
10 CENTER DRIVE
BLDG 10 RM 10B16
BETHESDA, MD 20892
BASIS OF AWARD
A determination by the Government not to compete this proposed contract acquisition based upon responses to the notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. 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. Information provided will be used to assess tradeoffs and alternatives available for the potential requirement and may lead to the development of a solicitation. 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. Any solicitation resulting from the analysis of information obtained will be announced to the public in Federal Business Opportunities in accordance with the FAR Part 5. However, responses to this notice will not be considered adequate responses to a solicitation. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any nonproprietary technical information in any resultant solicitation(s).
Closing Statement: This notice is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.
A determination by the Government not to compete this proposed action based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.
All responses must be received by August 14, 2021 and must reference number EE21-005569. Responses may be submitted electronically to estrellaek@mail.nih.gov or hand delivered in person. Fax responses will not be accepted.
“All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.”