Pre-Sol_Posting_PTN_8-14-2024_2.pdf

Pre-Solicitation Notice Request for Proposals (RFP): 75N94024R00008 Title: Best Pharmaceuticals for Children Act Pediatric Trials Network

Contracting Office Address:

Department of Health and Human Services, National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Office of Acquisitions, 6710B Rockledge Drive Bethesda, MD 20892

Note: This synopsis follows a Sources Sought Notice that was released on January 3, 2024, under 75N94024R00008.

THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION

WILL BE ISSUED ON A LATER DATE.

Background:

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) intends to solicit proposals to establish an Indefinite-delivery, Indefinite- quantity (IDIQ) contract to support clinical activities for continuing the Best Pharmaceuticals for Children Act Program (BPCA)-sponsored clinical research program, where the Pediatric Trials Network (PTN) currently serves as the clinical trials infrastructure. The successful offeror shall provide the requisite personnel, facilities, and services to establish, conduct, and support regulatory rigorous pediatric clinical trials that lead to drug label updates and related services includes the following: expert consultation in pediatric clinical trials designs; clinical site management; clinical site monitoring for opportunistic, standard of care trials, and other low risk trial designs; pediatric clinical pharmacology expertise;

method development; product formulation consultation; drug distribution; and pediatric device validation. Data collected from the BPCA clinical program infrastructure will help inform pediatric labeling and will be used to develop publications, datasets, and other resources that will provide clinicians, researchers, and patients with new information on medication disposition and response in children.

The main objective of this project is to create an environment by which a Contractor can operate an effective infrastructure for conducting safe and effective pediatric clinical trials that lead to drug labeling updates and for performing ancillary activities in support of these trials. Although, the primary focus of this Contract is to support the BPCA Pediatric Trials Network clinical activities, NICHD also anticipates the need to utilize this Contract to acquire and/or support similar types of therapeutics focused research for other prioritized NICHD therapeutic activities.

BPCA 2022 authorizes NICHD to identify therapeutic gaps in pediatrics, which are pediatric diseases, disorders or conditions where more complete knowledge and testing of therapeutics (including drugs, devices and biologics) can be beneficial to the pediatric population. Under this legislation, the NICHD can foster additional research directly and tangentially related to children, which addresses issues such as developmental pharmacology, pharmacokinetics (PK), pharmacogenomics, biomarkers of disease, unique aspects of pharmacodynamic (PD) responses and outcomes to treatments, as well as areas such as lactation and the impact of maternal health on child health. In addition to gathering clinical trial data to improve labeling, NICHD seeks to gather epidemiology data on drugs already being used in routine clinical care; and utilize novel designs and tools in pediatric research such as electronic health record extraction, the results of which could help direct future NIH studies.

NICHD anticipates the need to initiate activities in approximately five (5) to ten (10) therapeutic areas, with multiple therapeutic approaches for each therapeutic area. The work will be performed under individual task orders. It is therefore likely that these activities will require multiple scientific and clinical investigators with expertise in various disease areas. At the present time, NICHD is anticipating, but will not be limited to, initiating studies in the following therapeutic areas:

Rheumatologic diseases Infectious disease Acute care including anesthesia and analgesia Neonatal therapeutic areas Lactation-related therapeutics Obesity-related pharmacology Biodefense and medical countermeasures Standard of care pharmacology research

The Contracting Officer's Representative (COR) along with the Contractor, may interact with researchers who either currently are (or will be) performing pre-clinical and clinical trial activities with researchers supported by other Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Networks and programs, and other NIH supported trials and networks. The COR and Contractor also may interact and engage with Industry, Advocacy groups, the private sector, and practitioner groups in research efforts that align with BPCA and NICHD priorities.

It is anticipated that a single cost-reimbursement IDIQ contract will be awarded for a period of performance of eight (8) years, beginning May 1, 2025. The RFP is anticipated to be posted on or about September 3, 2024, and may be accessed through the sam.gov website. The due date for submission of proposals in response to the RFP is anticipated to be on or about November 4, 2024. Information in the anticipated RFP supersedes any information in this pre-solicitation announcement. This acquisition is a full and open competition under the North American Industry Classification System (NAICS) code 541715.

Any questions concerning this announcement must be submitted by email to the following two Contracting Officers: Elizabeth Osinski, eo43m@nih.gov and Noor Shakeel, Contracting Officer, noor.shakeel@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 for this announcement is 75N94024R00008. All correspondence must cite the reference number as provided.

mailto:eo43m@nih.gov mailto:noor.shakeel@nih.gov