Notice of Intent to Sole Source: BioIVT Human Vaccinated Control Serum

The Centers for Disease Control and Prevention intends to award a sole source contract to BioIVT, LLC 123 FROST ST STE 115 WESTBURY, NY 11590-5030 The Centers for Disease Control and Prevention has a requirement for human vaccinated control serum. CDC requires controls for the lab created respiratory diseases assays. The controls will need to be from 20 healthy individuals who have received the pertussis vaccine. The collection date needs to be within 3 years after vaccination date.

These serum will be screened to confirm high titers of antibodies against pertussis and then utilized as control serum for assay improvements. Only BioIVT is capable of performing this requirement, as they meet the program’s specifications. These specifications are:

Unique Requirements: The specific requirement for human serum from donors with confirmed TDAP vaccination sets this procurement apart from conventional sources of human serum. This specificity is crucial for research projects where the presence of antibodies against TDAP (Tetanus, Diphtheria, and Pertussis) is a prerequisite.

Reliability and Consistency: BioIVT has established a reliable network of clinical sites with donors who have undergone TDAP vaccination within the past three years. This network ensures access to serum samples meeting the required specifications, minimizing variability in research outcomes.

Ethical Collection Protocols: BioIVT adheres strictly to ethical guidelines and regulations governing the collection of human biological materials. CDC collection protocols prioritize donor welfare, informed consent, and confidentiality, ensuring compliance with relevant ethical standards and regulations such as the Declaration of Helsinki and local Institutional Review Board (IRB) requirements.

Quality Assurance: By sourcing human serum from donors with confirmed TDAP vaccination through our established network and regulated protocols, CDC can guarantee the quality and integrity of the samples. This includes maintaining stringent quality control measures throughout the collection and processing stages.

Research Continuity: Procuring human serum from a vendor with confirmed TDAP vaccination status mitigates the risk of lengthy evaluations of samples that would be required if a different vendor was used. This ensures uninterrupted progress for ongoing and future research projects dependent on these specific serum samples. Other vendors may have repositories of disease state serum but do not have large volumes or the ability to collect pertussis vaccinee serum with the reasons stated above.

Samples of BioIVT’s collection of TDAP (Tetanus, Diphtheria, and Pertussis) vaccinated and non-vaccinated serum have already been tested and evaluated to make sure they meet program’s needs. Other samples from BioIVT or other entities would require a lengthy and costly evaluation process that would hinder performance of the program’s work. This contract action is for supplies or services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 13.106-1(b)(1).

BioIVT is the only source capable of fulfilling this requirement. Interested persons may identify their interest and capability to respond to the requirement or submit proposals. This notice of intent is not a request for competitive quotations; however, all quotations / responses received within fifteen (15) days of the issuance of this notice will be considered by the government.

A determination by the government not to compete this proposed contract 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 a competitive procurement. Any response should be emailed to contract specialist at ttu3@cdc.gov. Questions or responses will not be accepted by phone.