SOURCES SOUGHT
A -- Best Pharmaceuticals for Children Act (BPCA) Data Coordinating Center (DCC)
- Notice Date
- 10/27/2015
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch, 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, Maryland, 20892-7510
- ZIP Code
- 20892-7510
- Solicitation Number
- NIH-NICHD-OPPTB-SBSS-10
- Point of Contact
- Deborah Brock, Phone: 301.435.6961, Alice M. Pagan, Phone: 301-435-6959
- E-Mail Address
-
deborah.brock@nih.gov, alice.pagan@nih.gov
(deborah.brock@nih.gov, alice.pagan@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- 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 541711 in the North American Industry Classification System (NAICS), and the small business size standard for such requirements is 500 employees. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH) is planning to award a contract for a BPCA Data Coordinating Center (DCC) responsible for providing the requisite personnel, facilities and services to support aspects of data collection, analysis and regulatory reporting for the pediatric clinical trials, and select preclinical data conducted under the authority of the Best Pharmaceuticals for Children Act (BPCA). BPCA was initially authorized by Congress in 2002 and reauthorized in September 2007 and September 2012, to improve labeling information for drugs used to treat children. BPCA Structure - NICHD has established a consortium of contractors to provide overall support for BPCA activities. This structure requires a high level of interaction among the various contractors and with NICHD. This structure, termed the BPCA Consortium, works together to construct, implement, monitor and report the clinical and preclinical activities within the BPCA to improve the knowledge and labeling of drugs, biologics and devices used in children. Communications and collaborations amongst all Consortium contractors occur through regular scheduled teleconferences, on-line activities, and face to face meetings. The Consortium consists of the following contracts in support of BPCA: •BPCA Pediatric Trials Network (PTN) serves as the master contractor for the conduct of preclinical and clinical trial studies under BPCA. •BPCA Data Coordinating Center (DCC) to manages and houses all of 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. •NICHD Repository to tracks and stores all of the biological specimens generated from BPCA clinical trial activities. A major responsibility of the BPCA-DCC will be to provide state of the art data capture, data sharing and assuring data quality in order to integrate the data from the clinical trials across dissimilar clinical specialties, and clinical sites. This also includes the integration of data from preclinical studies as well. The DCC's primary responsibility will be to insure integrity of the data collected and the regulatory compliance with the 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, and data analysis and data storage for the generation and submission of all necessary reports to the FDA. The Contractor shall understand and 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 and the submission of final data sets to the FDA Docket. The responsibilities of the BPCA-DCC will fall within the following categories: •Develop a Transition Plan and continuance of regulatory support for 25 ongoing BPCA clinical trials and approximately 25 additional new trials and activities during the performance of this contract. •Establish and manage a 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 BPCA. 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. •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. •Develop, coordinate, and maintain a BPCA Data Safety Monitoring Plan, to include the establishment and/or maintenance of the Data Safety Monitoring Board. •Provide clinical site monitoring, training and auditing necessary for protocol implementation and data quality review for all clinical and preclinical sites. •Provide Statistical leadership for the analysis of clinical trials data for submission to the FDA-includes interim analyses and analyses for final study report. •Participate in the Steering Committee of the BPCA Consortium and provide logistics support for the Committee. 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 to 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 25 on-going pediatric clinical trials and approximately 25 additional new trials and activities at any given time, 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, and 2 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 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. 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. 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 November 12, 2015. Responses should be no more than 15 pages. These pages exclude resumes. Capability statements should be emailed to: Deborah.Brock@nih.gov and Alice.Pagan@nih.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NICHD/NIH-NICHD-OPPTB-SBSS-10/listing.html)
- Place of Performance
- Address: TBD, United States
- Record
- SN03930996-W 20151029/151027234229-58d3dce52852bd02bb7f026ced4143d6 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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