OPPT/DH - Immunogenicity assessment of codon & codon-pair optimized factor VIII

This solicitation for commercial items prepared in accordance with the format in FAR 12.6 and FAR 13.0 as supplemented with additional information in this notice. Proposals are being requested from selected sources only, and this announcement constitutes the only solicitation. The Government contemplates issuing a firm fixed-price order as a result of this solicitation. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2020-07 dated August 11, 2021.

The associated North American Industrial Classification System (NAICS) code for this procurement is 541990, with an associated size standard of 5,000 employees.

This propose simplified acquisition solicitation is for services; the Government is  soliciting only to after exclusion of sources. Interested parties may identify their interests and capabilities to respond to the requirement within seven (7) days after the publication of this notice. A determination by the Government not to reissue and recompete this proposed simplified acquisition based upon responses to this notice, is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct another competitive requirement. No further solicitation is available.

FDA will consider all responses received prior to the closing date of this notice and will use responses in determining, whether it is necessary to use full and open competition for this requirement. Responses shall be emailed to Natapol Sirikhan, Natapol.Sirikhan@fda.hhs.gov, by August 14, 2023, 12:00 PM EST.