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This amendment is to post the approved J&A for the pre-solicitation notice below.

The Maternal and Pediatric Infectious Disease Branch (MPIDB), within the Eunice Kennedy Shriver National Institute of Child Health and Human Development ((NICHD), National Institutes of Health, intends to negotiate on a sole source basis, under the authority of 41 U.S.C. 253 ( c )(1) and FAR 6.301-1(a)(2)(ii) a six (6) to eight (8) month continuation of its contract with Westat, Inc., entitled, “NICHD International and Domestic Pediatric and Maternal HIV Studies and Other High Priority Infectious Diseases Data Coordinating Center.” This extension will sustain the supporting services and the IMPAACT Network HIV and other high priority infectious disease clinical trials currently being performed on this contract until a new competitive contract can be solicited and awarded. It is critical that the services and work provided by Westat, Inc., not be interrupted as they are integral part to the success of the MPIDB pediatric and maternal clinical trials currently awarded and ongoing on the IDIQ contract.

As the incumbent Contractor, Westat conducts research and performs clinical trials, develops and carries out other research protocols, and provides necessary logistical, technical, administrative, and other support to maintain, coordinate, and manage a multi-site network of domestic and international clinical centers investigating treatment, prevention, diagnosis, epidemiology, and natural history of HIV infection and disease and its infectious and non-infectious complications in pediatric, adolescent, and maternal patient populations, as well as other high priority infectious diseases affecting children and pregnant women.

Transitioning to a new contractor during such critical junctures as monitoring data, safety monitoring, recruitment and follow-up of patients, and any break in service would cause delays and could pose risk to the multiple clinical studies, data and patients. Specifically, interruption in these activities would result in unacceptable delays and unrecoverable losses in vital areas of the studies. In view of this, it is critical that these services and ongoing trials not be interrupted. This extension is necessary to allow sufficient time for the solicitation and award of the new competitive contract, but also time for a transition period, if a new Contractor is selected.

There will not be a solicitation or Request for Proposals (RFP) issued as a result of this announcement. Any responses or inquiries to this notice must demonstrate clear and convincing evidence that competition will be advantageous to the Government. All information received from this notice shall be used for planning and market research purposes only.

The Government will not pay for the preparation of any information submitted or use of such information. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the evaluation of the information received. Interested parties may respond and provide a capability statement no later than 4:00 pm., Eastern Standard Time (EST), October 17, 2022, via Email to Elizabeth Osinski, Contracting Officer, at eo43m@nih.gov and Alice Pagan, Contracting Officer, at alice.pagan@nih.gov. Emails must reference the announcement number in the subject line. This is not an RFP, and this announcement does not commit the Government to award a contract. The reference number to be used is HHSN275201800001I.