75N94026R00008_Presol_Notice_BPCA_DCC_3.pdf

PRE-SOLICITATION NOTICE

TITLE: Best Pharmaceuticals for Children Act Data Coordinating Center

NOTICE NUMBER: 75N94026R00008

THIS IS A PRE-SOLICITATION NOTICE ONLY. THIS IS NOT A REQUEST FOR PROPOSALS

(RFP). NO PROPOSALS ARE BEING SOLICITED OR WILL BE ACCEPTED IN RESPONSE

TO THIS NOTICE.

The National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), intends to issue a solicitation for the Best Pharmaceuticals for Children Act (BPCA) Data Coordinating Center (DCC) through full and open competition under North American Industry Classification System (NAICS) code 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). The Government anticipates awarding a single Indefinite- Delivery, Indefinite-Quantity (IDIQ) cost-reimbursement contract with a ten (10)-year ordering period.

BPCA was initially authorized by Congress in 2002 and reauthorized in 2007 and 2012 to improve labeling information for drugs used to treat children. The BPCA DCC will perform data coordination, data management, statistical analysis, and regulatory reporting activities for pediatric clinical trials and select preclinical studies conducted under the authority of BPCA.

BPCA Consortium Structure

NICHD has established a consortium of contractors to conduct BPCA activities. This structure, referred to as the BPCA Consortium, requires a high level of interaction among contractors and with NICHD to develop, implement, monitor, and report clinical and preclinical activities within BPCA in order to improve the knowledge and labeling of drugs, biologics, and devices used in children. Communications and collaborations among Consortium contractors occur through regularly scheduled teleconferences, online activities, and in-person meetings.

The Consortium consists of the following contracts under BPCA:

• BPCA Pediatric Trials Network (PTN): serves as the primary contractor for the conduct of preclinical and clinical trial studies under BPCA.

• BPCA Data Coordinating Center (DCC) will manage and maintain the data generated from the PTN, including leadership, tracking and submission of all U.S. Food and Drug Administration (FDA) regulatory documents generated under the BPCA Program.

A major responsibility of the BPCA DCC will be to establish and maintain state-of-the-art data capture, data sharing, and data quality oversight processes to integrate and manage data from clinical trials conducted across multiple clinical specialties and sites. This responsibility also includes integration of data from preclinical studies. The BPCA DCC’s primary responsibility will be to ensure the integrity of collected data and compliance with the FDA and NICHD requirements governing the conduct of clinical and preclinical studies.

The BPCA DCC will conduct data collection, tracking, analysis, and storage activities necessary for the preparation and submission of required reports to the FDA and the NICHD Data and

Specimen Hub (DASH). The Contractor shall be responsible for understanding, performing, and coordinating regulatory activities for the BPCA clinical program, including as applicable, the preparation and submission of Investigational New Drug (IND) applications and New Drug Applications (NDAs) under BPCA authority.

BPCA regulatory activities may also include tracking Study Requests on behalf of NICHD;

preparing and submitting meeting requests and meeting packages; and preparing final datasets for submission to the FDA docket and DASH. The anticipated responsibilities of the BPCA DCC are expected to include, but are not limited to, the following:

• Develop a transition plan addressing: (1) archiving of data and trial master files for approximately 40 closed studies; (2) continuation of regulatory, statistical, and data management activities for approximately 10 ongoing BPCA clinical trials; and (3) continuation of regulatory, statistical, and data management activities for approximately 20 additional new trials and related activities during contract performance.

• Establish and manage a data collection, data analysis, and data storage system for pediatric clinical and preclinical activities conducted under BPCA, including the development and maintenance of de-identified datasets for the FDA submission, final study reports, and public-use datasets, as applicable.

• Lead and perform regulatory activities associated with BPCA-related Investigational New Drug (IND) applications and New Drug Applications (NDAs), including supplemental NDAs, and coordinate and manage communications with the FDA related to clinical and preclinical trials and associated data.

• Develop, coordinate, and maintain a BPCA Data Safety Monitoring Plan, including establishment and ongoing management of the Data Safety Monitoring Board (DSMB).

• Conduct clinical site monitoring, training, and auditing necessary for protocol implementation and data quality review for clinical and preclinical sites, estimating approximately 50 clinical sites per contract year.

• Provide statistical leadership for the analysis of clinical trial data for the FDA submission, including interim analyses and analyses required for final study reports.

• Participate in the BPCA Consortium Steering Committee and coordinate logistics for committee meetings, conference calls, and related activities.

Performance of the BPCA DCC functions will require demonstrated expertise in pediatric clinical trial data coordination, biostatistics, regulatory affairs, clinical trial monitoring, information technology, and related administrative functions necessary to collect, manage, analyze, and report data generated through BPCA clinical and preclinical studies. The forthcoming solicitation is expected to require offerors to demonstrate proven experience performing these activities for complex, multi-site pediatric research programs.

I. Anticipated Offeror Experience and Capability Areas: Clinical, Regulatory, Data Management, and Operational

The forthcoming solicitation is expected to require offerors to demonstrate experience and capability in the following scientific, regulatory, data management, and operational areas associated with the conduct of BPCA clinical and preclinical studies. The list below is provided for advance planning purposes only and does not constitute a request for proposals or capability statements at this time.

a. Experience organizing, managing, and monitoring approximately 10 ongoing pediatric clinical trials and approximately 20 additional trials or related activities concurrently, with studies that may involve up to 50 domestic and international clinical sites.

b. Demonstrated capability and experience in performing regulatory requirements for pediatric drug development domestically and internationally including preclinical studies and Phase 1 and Phase 2 clinical trials involving pharmacokinetic, efficacy, and safety trials in pediatrics. This includes preparation and submission of INDs, NDAs, and related amendments required by the FDA and, as applicable, other regulatory agencies such as the European Medicines Agency (EMA).

c. Demonstrated capability to work effectively within a consortium of contractors and government stakeholders.

d. Capability and experience in developing de-identified public-use datasets that will inform the labeling of drugs used in children.

e. Demonstrated capability and experience in simultaneously managing multiple domestic and international clinical trials.

f. Capability and experience providing statistical leadership in the development of clinical and preclinical protocols for the FDA submission, including development of statistical analysis plans and related statistical analyses for BPCA clinical trial regulatory submissions.

g. Capability and experience in training and certifying site data coordinators and related study personnel.

h. Demonstrated capability and experience in developing and implementing standard operating procedures that define relationships, roles, and responsibilities among multiple contractors operating within a network.

i. Capability and experience in establishing and maintaining communication and reporting systems in compliance with the FDA requirements for submission of serious adverse event (SAE) and adverse event reports.

j. Capability to monitor the accuracy, completeness, and timeliness of adverse event reporting.

k. Capability in establishing and managing the activities of a Data Safety Monitoring Board (DSMB).

l. Capability in monitoring the accuracy, completeness, and quality of data collection, data entry, and data analysis.

m. Capability in quality control procedures, including adherence to good clinical and laboratory practices, site audits, internal database audits and database validation.

n. Capability and experience to ensure that each clinical site has a current approved Federalwide Assurance (FWA) on file with the Office for Human Research Protections (OHRP), as applicable.

o. Capability to establish and maintain a pharmacy program including the ability to ship, label, track, and monitor drug supply for ongoing clinical studies conducted under BPCA.

p. Capability to establish and maintain a specimen tracking system for ongoing clinical studies conducted under BPCA.

q. Ability to coordinate logistics for Steering committee teleconferences, meetings, and related activities.

II. Anticipated Offeror Experience and Capability Areas – Information Technology and

Security

The forthcoming solicitation is expected to require offerors to demonstrate experience and capability in the following information technology and security areas:

a. Experience establishing, administering, and maintaining a state-of-the-art, efficient, reliable, secure, and responsive systems for the collection, management, quality assurance, and reporting of study data.

b. Experience establishing and maintaining public-use datasets that can operate under tiered-access controls.

c. Experience establishing systems for secure electronic communications and data exchange among program stakeholders.

d. Capability to develop and maintain computer applications that meet applicable NIH and FISMA security requirements and enable data management, analysis, and storage for clinical trials conducted under BPCA. This includes demonstrated capability to prepare data and analyses for the FDA submissions, the FDA docket posting, public-use datasets, and peer-reviewed publications, as applicable.

Additional Information:

The RFP (75N94026R00008) is anticipated to be issued on or about August 14, 2026, with proposals anticipated to be due on or about September 28, 2026.

The RFP will be made available electronically through SAM.gov at https://sam.gov. All information necessary for the preparation and submission of proposals will be included in the solicitation package. Offerors are responsible for monitoring SAM.gov for the solicitation and any amendments that may be issued.

All responsible sources may submit a proposal, which will be considered by the agency. This notice does not commit the Government to award a contract or to pay any costs incurred in the preparation or submission of proposals.

Potential offerors are responsible for obtaining their own copy of the solicitation and any amendments. All questions regarding this notice shall be submitted electronically to the points of contact listed below.

Offerors must be registered in the System for Award Management (SAM) at https://sam.gov prior to contract award.

Primary Point of Contact Theresa Ranjit Contracting Officer Theresa.Ranjit@nih.gov

Secondary Point of Contact Noor Shakeel Contracting Officer Noor.Shakeel@nih.gov https://sam.gov/ mailto:Theresa.Ranjit@nih.gov mailto:Noor.Shakeel@nih.gov