BPCA_DCC_SBSS_1_13_2025_1.doc

SOURCES SOUGHT ANNOUNCEMENT

Best Pharmaceuticals for Children Act (BPCA) Data Coordinating Center (DCC) Synopsis

This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations.

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 method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This requirement is assigned a code of 541715 in the North American Industry Classification System (NAICS), and the small business size standard for such requirements is 1,000 employees or less.

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 with experts in pediatric research, to identify therapeutic gaps in pediatric diseases, disorders or conditions in which more complete knowledge of treatment strategies, including drugs and biologics, may be beneficial to the pediatric population. BPCA has been reauthorized several times, most recently in 2022.

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), specifically the 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 authorizes three main objectives for the Clinical Program:

1. Establishing priorities for pediatric therapeutics;

2. Funding clinical trials that will improve the knowledge of the dosing, safety, and effectiveness of drugs used in children; and

3. Submitting clinical trials data to the FDA for label change and then disseminating the findings for 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, and has had led to more than 20 updates to pediatric drug labels in the off-patent space.

The NICHD is planning to award a contract for a Best Pharmaceuticals for Children Act (BPCA) Data Coordinating Center (DCC) responsible for providing the requisite personnel, facilities and services to support aspects of data management, analysis, and regulatory reporting for the pediatric clinical trials, select preclinical data conducted under the authority of the BPCA, and other high priority regulatory rigorous clinical trials.

BPCA Structure The NICHD currently maintains an infrastructure of contracts to provide support for the various clinical activities in the BPCA Clinical Program. This infrastructure requires a high level of interaction with the NICHD and other responsible parties. This structure, henceforth termed “the Consortium”, works together to construct, implement, monitor, and audit pre-clinical and clinical activities to improve the knowledge and labeling of drugs, biologics, and devices used in children. The Consortium may also collaborate with other NICHD or NIH-funded networks, nonprofit organizations, other federal agencies, or pharmaceutical/biotechnology companies. Below are the responsible parties within the Consortium that support BPCA initiatives and projects:

· BPCA Data Coordinating Center (DCC; this contract) oversees data quality for the trials conducted under the BPCA program, including data capture, data management, and data storage, supports data safety monitoring and auditing for BPCA clinical trial activities, and monitors regulatory rigorous efficacy and other high-risk clinical trials.

· BPCA Pediatric Trials Network (PTN) serves as the network of researchers, sites, and other consultants that act as the infrastructure for the conduct and support of safe and effective BPCA pediatric clinical trials and related services.

· BPCA Logistics and Support Services provide literature reviews, scientific analyses, market surveys and conduct workshops, symposia, and conferences for the development of diverse pediatric therapeutic approaches to be utilized in the prioritization and selection of pediatric therapeutics for further study by BPCA.

A major responsibility of the BPCA DCC will be to provide state of the art data capture, data management, and data quality assurance for approximately 30 ongoing pediatric clinical trials/projects and up to 10 additional new trials or projects added yearly, each with approximately 15 clinical study sites. This also includes the integration of data from preclinical studies. The DCC’s primary responsibility will be to ensure integrity of the data collected and regulatory compliance with FDA and NICHD policies on the conduct of clinical and preclinical studies. The activities conducted by the BPCA DCC will support data collection, data tracking, data analysis, and data storage for the generation and submission of all necessary reports to the FDA and to the NICHD Data Repository (DASH). The Contractor shall understand, perform, and coordinate all of the regulatory responsibilities for NICHD, including the submission of Investigational New Drug (IND) applications and New Drug Applications (NDA), as applicable, under the BPCA authorization. The regulatory requirements of BPCA also include assisting NICHD in tracking Proposed Pediatric Study Requests, submitting meeting requests along with meeting packages, and the submission of final datasets to the NICHD Data Repository (DASH) and/or the FDA Docket. The responsibilities of the BPCA-DCC will fall within the following categories:

· Develop a Transition Plan for the following: (1) Archiving of data and trial master files for 20 closed studies; (2) continuance of regulatory, statistical and data management support for approximately 30 ongoing BPCA clinical trials and; (3) continuance of regulatory, statistical, and data management support for up to 10 additional new trials and projects per year during the performance of this contract.

· Establish and manage an electronic data collection, data analysis, and data storage system (in the form of de-identified datasets) that will support all pediatric clinical and preclinical activities under the BPCA and other high priority NICHD studies that is compliant with all federal, NIH, and NICHD policies, including FISMA. The data from these activities will be placed into datasets, developed and maintained by the Contractor for submission to the FDA in the form of a final study report and a public use dataset, as well as for publications, presentations, and other needs.

· Provide leadership and support for all regulatory requirements associated with BPCA-related Investigational New Drug (IND) Applications and New Drug Applications (NDA or supplemental NDA), including coordination and management of all communications with FDA for clinical and preclinical trials and data, as well as submissions for other high priority NICHD studies.

· Develop, coordinate, and maintain a BPCA Data Safety Monitoring Plan, to include the establishment and/or maintenance of the Data Safety Monitoring Board.

· Provide data quality assurance and auditing necessary for protocol implementation and data quality review for all clinical and preclinical sites, estimating approximately 120 clinical sites for each contract year and over 1000 participant enrollments per year.

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

· Provide statistical leadership for the analysis of clinical trials data for submission to the FDA, including interim analyses and analyses for the final study report.

· Participate in the Steering Committee and Executive Committee of the BPCA Consortium.

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

A broad range of regulatory, information technology, statistical, clinical trial coordination and monitoring, and administrative expertise will be necessary to carry out the requirements of this solicitation. The Contractor shall be expected to demonstrate proven expertise in providing these requirements.

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 a 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 organizing, managing and monitoring approximately 30 ongoing pediatric clinical trials and approximately 10 additional new trials and activities per contract year, where each study may have up to 60 clinical study sites, both domestic and international.

b. Demonstrated capability and experience in performing all regulatory requirements for pediatric drug development domestically and internationally including: preclinical, Phases 1, 2, and 3 clinical trials in the areas of pharmacokinetic, efficacy, and safety trials in pediatrics. This includes the capability and experience in preparation and submission of IND and NDA applications and amendments required by the U.S. FDA and other international regulatory agencies, such as the European Medicines Agency (EMEA).

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. This includes the capability in providing statistical expertise and the development of statistical analysis plans for all regulatory submissions of BPCA clinical trials.

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 data base 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 conducted under BPCA.

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

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 conducted under BPCA and other high priority 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 otherwise 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 published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

Small businesses that believe they possess the capabilities necessary to undertake this project should submit an electronic copy of their capability statement, addressing the areas above. Capability statements must identify organization name, address, point of contact, the business status, size and type of business (e.g., 8(a), HUBZone, etc) pursuant to the applicable NAICS code and DUNS number.

Written capability statements should be received by the Contracting Officer by no later than January 28, 2025. Responses should be no more than 15 pages. These pages exclude resumes. Capability statements should be emailed to: Deborah.Brock@nih.gov and Ty.Main@nih.gov .

PAGE