A--Data Coordinating Center for BPCA

Amendment / Modification

• The response due date for the Sources Sought Notice is extended.

• Original due date: March 31, 2026, at 4:00 PM EDT.

• New due date: April 6, 2026, at 4:00 PM EDT.

• The deadline for submitting responses to the Sources Sought Notice.

• Proposal deadlines have been extended. All other terms and conditions remain unchanged.

Sources Sought / Request for Information

This notice is issued for market research purposes only to determine the availability and capability of qualified small business sources for a Data Coordinating Center (DCC) to support the Best Pharmaceuticals for Children Act (BPCA) Clinical Program. This is NOT a solicitation for proposals, and no contract will be awarded from this notice.

The government is seeking information on capabilities related to:

• Operating a BPCA Data Coordinating Center (DCC).
• Providing personnel, facilities, and services for regulatory-rigorous aspects of clinical data management, statistical analysis, and FDA regulatory expertise and reporting for pediatric drug development clinical trials.
• Supporting approximately 15 concurrent pediatric clinical trials and up to 3 additional new trials annually, potentially involving domestic and international sites.
• Providing state-of-the-art data capture, innovative data collection, data integrity, and quality assurance.
• Supporting regulatory activities associated with FDA-regulated clinical research, including IND/NDA submissions and coordinating regulatory documentation.
• Developing de-identified public use datasets.
• Establishing and managing electronic data collection, analysis, and storage systems compliant with federal requirements.
• Providing regulatory support for IND and NDA activities, and Clinical Study Report revisions.
• Developing and maintaining Data Safety Monitoring Plans and supporting Data Safety Monitoring Boards.
• Providing data quality assurance auditing.
• Supporting monitoring and training compliance for high-risk clinical trials.
• Providing statistical leadership for analyses and FDA submissions.
• Supporting the BPCA Consortium Steering and Executive Committees.
• Providing expertise in protocol development for pediatric clinical trials.
• Information Technology and Security capabilities for data collection, management, quality assurance, reporting, and electronic communication.

Not applicable, as this is a Sources Sought notice.

• Interested small businesses should submit a capability statement addressing the technical areas of experience and expertise outlined in the document.

• Responses must include organization name, address, point of contact, business size, socioeconomic status, and UEI number. Teaming arrangements may be described.

• Responses are due no later than March 31, 2026, 4:00 PM EDT.

• Responses should be submitted electronically to Theresa.Ranjit@nih.gov and Noor.Shakeel@nih.gov.

• This notice is specifically seeking information from small businesses.

• Organizations that are not considered small business under NAICS code 541715 (Research and Development in the Physical, Engineering, and Life Sciences, except Nanotechnology and Biotechnology, with a size standard of 1,000 employees or less) should not submit a response.

• The government will use the responses to determine the appropriate acquisition strategy, including whether a total small business set-aside is possible.

• Responses will not be considered adequate responses to a future solicitation.

• Do not include proprietary, classified, confidential, or sensitive information.