BPCA_DCC_SBSS_3_16_26_1.pdf

SOURCES SOUGHT ANNOUNCEMENT

Data Coordinating Center for Best Pharmaceuticals for Children Act

Synopsis

This is a Small Business Sources Sought notice issued for market research purposes only. This is NOT a solicitation for proposals, quotations, or bids and no contract shall be awarded from this notice.

The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses;

and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition strategy, including whether a total small business set-aside is possible. Organizations that are not considered small business under the applicable NAICS code should not submit a response to this notice.

This requirement is assigned NAICS code of 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. The requirement primarily supports biomedical research through statistical analysis and data coordination activities integral to pediatric clinical research.

Background

The Best Pharmaceuticals for Children Act (BPCA) mandates the establishment of a pediatric drug development program for studying on- and off-patent drugs in children set forth under Part B, Title IV, section 409I (a) and (b) of the Public Health Service Act (PHS Act). The original BPCA of 2002 directed the Secretary of the Department of Health and Human Services (DHHS), acting through the Director of the National Institutes of Health (NIH), and delegated to the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the authority and responsibility for establishment and conduct of the research program. The BPCA legislation authorizes the NIH, in consultation with the Food and Drug Administration (FDA) and pediatric research experts, to identify therapeutic gaps in pediatric diseases, disorders, or conditions in which more complete knowledge of treatment strategies, including drugs and biologics, can be studied in order to benefit the pediatric population. BPCA has been reauthorized several times, most recently in 2022.

The NICHD Obstetric and Pediatric Pharmacology and Therapeutics Branch (OTTPB) administers the research program (hence forth termed the “BPCA Clinical Program”) and works cooperatively with other NIH Institutes and Centers (ICs) with significant pediatric research portfolios to fulfill the mandate to improve pediatric therapeutics. The BPCA Clinical Program has three primary objectives:

1. Establish priorities for pediatric therapeutics;

2. Fund clinical trials to improve the knowledge of the dosing, safety, and effectiveness of drugs used in children; and

3. Submit clinical trial data to the FDA for label changes and disseminate findings to the research and clinical care communities.

Since the BPCA was initiated, NICHD has collaborated with NIH colleagues in other Institutes and Centers, the FDA, and many experts in pediatrics, public health, and pharmacology to determine priorities in pediatric therapeutics and to conduct trials in those prioritized areas that lead to drug label changes. Because of these collaborations, and from input gathered during previous years, the BPCA Clinical Program has prioritized and studied more than twenty (20) therapeutic areas, has conducted more than fifty (50) clinical studies, has submitted close to thirty (30) clinical study reports to the FDA, leading to more than 26 updates to pediatric drug labels in the off-patent space.

The NICHD anticipates a requirement for a contractor to operate a BPCA Data Coordinating Center (DCC) to provide personnel, facilities and services to support regulatory rigorous aspects of clinical data management, statistical analysis, and FDA regulatory expertise and reporting structures for pediatric drug development clinical trials.

BPCA Structure

The NICHD maintains an infrastructure of contracts and grants supporting clinical activities within the BPCA Clinical Program. This Consortium of collaborators construct, implement, monitor, and audit clinical activities to improve knowledge and labeling of drugs, biologics, and devices used in children. Participants may collaborate with other NIH networks, nonprofit organizations, federal agencies, and pharmaceutical or biotechnology companies. Responsible parties include:

• BPCA Data Coordinating Center (DCC) oversees data quality for the trials conducted under the BPCA program, including data capture, data management, data storage, data safety monitoring, auditing, and monitoring of regulatory-rigorous clinical trials.

• BPCA Pediatric Trials Network (PTN) serves as the network of researchers, clinical sites, and experts in pediatric drug development that act as the infrastructure for the conduct and support of safe and effective BPCA pediatric clinical trials and related services.

NICHD anticipates a requirement for the DCC to provide state-of-the-art data capture, innovative data collection (including tracking, analyses, and storage), expertise in regulatory management and support, and data integrity and quality assurance for approximately 15 concurrent pediatric clinical trials/projects and up to 3 additional new trials or projects per year, each involving approximately 20 clinical study sites. Activities will support clinical study report generation and submission to FDA for label change considerations and redacted data to the NICHD Data Repository (DASH). The Government is interested in understanding the extent to which small businesses have experience supporting regulatory activities associated with FDA-regulated clinical research. This may include supporting preparation of Investigational New Drug (IND) or New Drug Application (NDA) submissions, coordinating regulatory documentation and communications, assisting with preparation of regulatory meeting materials, and supporting submission of study data and datasets to appropriate repositories such as the NICHD Data and Specimen Hub (DASH) or FDA docket systems. Responses should describe relevant experience supporting these types of regulatory processes in the context of clinical research programs. Examples of related capability areas include:

• Develop a transition plan for archiving data and trial master files for approximately 30 closed studies and continuing regulatory, statistical, and data management support for ongoing and new trials.

• Establish and manage electronic data collection, data analysis, and data storage systems compliant with federal, NIH, NICHD, and FISMA requirements, including creation of de‑identified datasets for regulatory submission and public use.

• Provide regulatory support including coordination of FDA communications and support for Investigational New Drug (IND) and New Drug Application (NDA) activities, and Clinical Study Report revisions in discussion with relevant FDA review divisions.

• Develop and maintain a Data Safety Monitoring Plan and support to include the establishment and/or maintenance of a Data Safety Monitoring Board.

• Provide data quality assurance auditing necessary for protocol implementation and data quality review for all clinical and preclinical sites, estimating for approximately 50 clinical sites and more than 500 participant enrollments annually.

• Support monitoring and training compliance for high-risk, regulatory rigorous clinical trials such as randomized clinical trials or efficacy studies.

• Provide statistical leadership including interim analyses, statistical analysis plans, and final analyses supporting FDA submissions.

• Participate in BPCA Consortium Steering and Executive Committees.

• Provide expertise and collaborate with PTN and other investigators in protocol development, particularly for pediatric clinical trials.

Small businesses that submit capability statements in response to this notice will be evaluated against the following technical areas of experience and expertise:

I. Provide description and documented evidence of the experience and expertise of the staff. Provide names of projects and references, noting those in support of submission of final clinical study data and datasets in a format suitable for submission to the FDA for drug studies, distinguishing previous experience from current projects. Response must include sufficient detail to demonstrate:

a. Experience in managing approximately 15 concurrent pediatric clinical trials and up to 3 additional trials annually, potentially involving domestic and international sites.

b. Demonstrated regulatory support for pediatric drug development including Phase 2 and Phase 3 trials, pharmacokinetic, efficacy, and safety studies, and preparation of IND/NDA submissions to FDA or international regulatory agencies.

c. Demonstrated capability to work in a consortium of contractors.

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 clinical trials domestically and internationally.

f. Capability and experience in providing statistical leadership in the development of clinical and preclinical protocols for submission to the FDA.

g. Capability and experience in training and certification for data coordinators of study sites.

h. Demonstrated capability and experience in developing and implementing standard operating procedures that detail and delineate relationships and responsibilities between the multiple contractors in a network.

i. Capability and experience in establishing and maintaining a communication system in compliance with FDA requirements for the submission of Serous Adverse and Adverse Event Reports.

j. Capability in monitoring accuracy of adverse event reporting.

k. Capability in establishing and supporting all of the activities of a Data Safety

Monitoring Board.

l. Capability in monitoring the accuracy, completeness and quality of data gathering, data entry, and data analysis of regulatory rigorous clinical trials.

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

n. Capability and experience to assure that each clinical site has a current approved Federal Wide Assurance Number on file with the Office for Human Research Protection (OHRP).

o. Capability to acquire and maintain a pharmacy program including the ability to ship, label, and monitor drug supply for ongoing clinical studies.

p. Capability to acquire and maintain a specimen tracking system for ongoing clinical studies.

q. Ability to provide logistical support to the Steering committees for teleconferences and meetings.

II. Provide a description and documented evidence of the experience and expertise of the organizations Information Technology and Security capabilities. Response must include sufficient detail to demonstrate:

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

b. Experience in establishing and supporting public use datasets that can operate under tiered access.

c. Experience in establishing a system for electronic communication linkages among various stakeholders.

d. Capability to develop computer programs, meeting NIH FISMA security requirements, that will support the data management, analyses, and storage for the clinical trials. This includes demonstrated capability in preparation of data and data analysis for the development of datasets that will be submitted to the FDA, published on the FDA docket, and public use datasets that can be used for peer reviewed publications, for example.

Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be posted on SAM.gov at a later date.

However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality. Do not include proprietary, classified, confidential, or sensitive information in your responses. The Government reserves the right to use any non-proprietary information in any resultant solicitation.

Submission Instructions. Interested small businesses should submit an electronic copy of their capability statement addressing the areas above. Responses must include organization name, address, point of contact, business size and socioeconomic status under the identified NAICS code, and UEI number. Teaming arrangements may be described if applicable.

Responses shall be no more than 15 pages, single‑spaced, using 11‑point font or greater (excluding resumes).

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

Submit responses electronically to: Theresa.Ranjit@nih.gov and Noor.Shakeel@nih.gov.

mailto:Theresa.Ranjit@nih.gov mailto:Noor.Shakeel@nih.gov