SOURCES SOUGHT
A -- Pumps for Kids, Infants, and Neonates (PumpKIN) Clinical Trial
- Notice Date
- 10/18/2016
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- HHS-NIH-NHLBI-SBSS-10
- Archive Date
- 11/17/2016
- Point of Contact
- Roxane Burkett, Phone: 301-594-4588
- E-Mail Address
-
burkettr@mail.nih.gov
(burkettr@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Introduction This Sources Sought Notice is for interested small businesses. 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 small businesses are classified as HUBZone; service-disabled, veteran-owned; 8(a); veteran-owned; woman-owned; or small disadvantaged; and (3) the size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition for any interested businesses. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. The NAICS code for this acquisition is 541712. An organization that is not considered a small business under NAICS code 541712 should not submit a response to this notice. Background The National Heart, Lung, and Blood Institute (NHLBI) is seeking a Data Coordinating Center (DCC) for an ongoing program – the Pumps for Kids, Infants, and Neonates (PumpKIN) Clinical Trial. The objective of the trial will explore the potential benefit of therapy offered by a novel pediatric circulatory support device to infants, neonates, and young children (<25 kg) with congenital and acquired cardiovascular disease who experience cardiopulmonary failure and circulatory collapse. As the PumpKIN DCC, the contractor will have the overall responsibility for the operation of the trial and will provide the necessary administrative guidance, oversight, and support to achieve the trial’s objectives. PumpKIN is currently completing Task Areas 1 and 2 of IDIQ Contract HHSN268201200001I. Tasks Areas 3, 4, and 5 still need to be completed. As result, the NHLBI anticipates extending the period of performance of the PumpKIN program from October 19, 2019 to September 15, 2023 to complete the Clinical Trial and Trial Closeout. PROJECT REQUIREMENTS During the period from January 1, 2017 – September 15, 2023, the Data Coordinating Center (DCC) is expected to provide the necessary technical expertise and facilities to effectively perform the tasks and meet the requirements identified below. Task Area 3 - Active Clinical Trial Phase: Manage Clinical Sites to; enroll the number of subjects that meet the selection criteria in the FDA-approved IDE for the trial/device, implement the PumpKIN MOP and Protocol developed in Phase I, and follow each of the enrolled patients for the specified time in the protocol. Note: The DCCC will drop and add clinical sites as needed during the trial per plans and procedures approved by the NHLBI in order to meet patient recruitment goals. Monitor patient recruitment and provide weekly reports to the clinical centers, the NHLBI Project Office, and core laboratories during the recruitment phase. Provide weekly reports on patient adherence and retention to the clinical centers, the NHLBI Project Office, and core laboratories. Implement a monitoring plan that includes the responsibility for evaluating and correcting adherence and retention problems. Ensure quality control (QC) at participating clinical sites and monitor their performance status; promote interactions among the clinical sites, coordinate trial activities among the clinical sites and core laboratories, and ensure uniformity of trial activities at all sites; perform data audits and provide rapid feedback to the clinical sites and core laboratories on the quality of data submitted and proposed corrections; conduct periodic site visits to each clinical center in order to monitor and ensure high performance throughout the trial; report to the NHLBI Project Office on QC and related matters periodically as specified for each report in the protocol and as needed. Analyze ongoing trial data per the data analysis plan. Prepare trial publications, reports, and other scientific manuscripts in collaboration with the Steering Committee (SC). Prepare and distribute technical and statistical reports per Article C.2. At least weekly, review trial activities, including progress in recruitment. Review data to ensure scientific validity and guarantee that the policies to ensure safety and to protect the privacy of the human subjects in the trial are being properly followed. Establish and conduct timely reviews of adverse events to classify all clinical outcome events in a uniform fashion. Implement a plan for timely monitoring of adverse events to maximize patient safety. Monitor end point results, morbidity and mortality data, and adverse event reports for patterns that may warrant changes in the trial. Provide notification and reports per the trial protocol and MOP. Adverse events shall be reported in accordance with NHLBI policies found at: http://www.nhlbi.nih.gov/funding/ethics.htm. Prepare and submit required reports to the FDA. (See http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm046717.htm#sugforforidepro for information regarding IDE reports.) Design and implement a plan for trial closeout, analysis, and dissemination, including final data collection, data transfer (if necessary), verification, analytical support for scientific writing groups, publication of trial results, and plans for the investigators’ dissemination of trial results. Task Area 4 - Administrative Support during Clinical Trials: Work with the Clinical Sites to maintain IRB approval. Maintain all trial documentation, including IRB approvals, informed consents, Federal Wide Assurance documentation, conflicts of interest, and proof of human subjects training of PIs, Co-PIs, and Coordinators at the clinical sites. Make travel arrangements and provide reimbursement for the SC Chair to participate in SC meetings and related activities. Coordinate, plan, make arrangements for, and participate in the meetings of the SC and its subcommittees and other meetings related to the conduct of the trial. Coordinate, plan, and make arrangements for members of the Data and Safety Monitoring Board (DSMB). DSMB Guidelines can be found at http://www.nhlbi.nih.gov/research/funding/human-subjects/data-safety-monitoring-policy Facilitate communications among all organizational trial components, including the DSMB, ad hoc task forces or working groups, and subcommittees; prepare and/or distribute minutes and reports of the SC, Executive Committee, DSMB meetings, and subcommittee meetings, ensuring the quality and accuracy of data collection and report content. Maintain in the central trial website a repository of minutes and materials necessary to the functioning of the various committees and all other aspects of the trial. Specifically: Coordinate, arrange, participate in, and provide information necessary for regular SC meetings. Coordinate, arrange, participate in, fund, and provide any information for meetings and conference calls with the clinical investigators. Prepare weekly reports of patient screening, recruitment, status of data collection and quality control, and all other matters needed to be discussed at SC meetings or during conference calls. Arrange regular DSMB activities. Provide trial data to the DSMB per the trial protocols and as requested. Fund all DSMB-related activities, including travel expenses for meetings, honoraria to members, and meeting room charges. Computer Systems and Websites: Maintain the computer system, secure trial database, and software needed for the collection, storage, and analysis of all trial data (including biological specimens) from all PumpKIN clinical sites and core laboratories. Provide computer backup systems in the event of a primary system failure. Maintain documentation of the data variables and maintenance of appropriate confidentiality and security of all computer files. If the Government or pubic accesses the electronic data capture and management system, it shall be in compliance with the Section 508 standards. The Section 508 Applicable Electronic and Information Technology (EIT) Accessibility Standards are as follows: Subpart B - Technical Standards Software Applications and Operating Systems (1194.21) Web-based Intranet and Internet Information and Applications (1194.22) Video and Multimedia Products (1194.24) Subpart C - Functional Performance Criteria Functional Performance Criteria (1194.31) Subpart D - Information, Documentation, and Support Information, Documentation, and Support (1194.41) Maintain the trial website for the distribution of PumpKIN information, documents, and forms to the clinical sites. The website designed under this contract shall meet the requirements of Section 508 of the Rehabilitation Act as described above. Submit an updated Information Systems Security Plan as required by the NHLBI Information Systems Security Officer. Publications and Presentations Work with the SC to establish a publications and presentations policy and infrastructure for review/prioritization of manuscripts and abstracts. Task Area 5 - Closeout: Analyze data and prepare trial reports, publications, and other scientific manuscripts in collaboration with the SC. In collaboration with NHLBI staff and other trial investigators, finalize the dissemination plan for trial results. This task includes trial closeout and dissemination activities for the PumpKIN trial. Additionally, trial reports shall be provided to the pre-clinical PumpKIN contractor for their HDE application. Create a public use dataset and implement the Data Sharing Plan. Prepare accompanying documentation that meets the requirements for a Limited Access Dataset. [See http://www.nhlbi.nih.gov/research/funding/human-subjects/set-preparation-guidelines] Provide a final report that documents and summarizes the results of the entire contract work and a final complete data set with detailed, clearly understandable documentation. Prepare and submit required final reports to the FDA and the PumpKIN Pre-clinical contractor and/or sponsor of the IDE. CAPABILITY STATEMENT – HOW TO SUBMIT A RESPONSE Small business concerns that believe they possess the capabilities necessary to undertake this work should submit complete documentation of their capabilities to the Contracting Officer. The capabilities statement must specifically address each project requirement separately. Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of scientists, medical experts, and technical personnel as it relates to the above outlined requirements, 3) a description of general and specific facilities and equipment available, including computer equipment and software, 4) an outline of previous research projects that are similar to the project requirements in which the organization and proposed personnel have participated, and 5) any other information considered relevant to this program. The capability statement must not exceed 15 single sided or 7.5 double sided pages in length and using a 12-point font size minimum. Interested small business organizations are required to identify their size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone numbers of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. Point of Contact: Roxane Burkett, Contracting Officer, NHLBI, ECB Branch, Phone (301) 435- 6671, burkettr@nhlbi.nih.gov. Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions 6701 Rockledge Dr RKL2/6016 MSC 7902, Bethesda, MD, 20892-7902, UNITED STATES Submission Instructions: Interested parties shall submit capability statements via the FedConnect web portal ( www.fedconnect.net ) and reference the FedConnect Sources Sought Number HHSN26817HV00003R. The due date for receipt of statements is 3:00 pm Eastern Time on November 2, 2016. Vendors can register with FedConnect at https://www.fedconnect.net/FedConnect/default.htm. Please note that FedConnect is used by multiple federal agencies and therefore FedConnect assistance will be provided by Compusearch Software Systems, not the NHLBI OA. More information about registration requirements can be found by downloading the FedConnect Ready, Set, Go! Guide at https://www.fedconnect.net/fedconnect/Marketing/Documents/FedConnect_Ready_Set_Go.pdf. For assistance in registering or for other FedConnect technical questions please call the FedConnect Help Desk at (800) 899-6665 or email at support@fedconnect.net. Please use the Contracting Officer/ Contract Specialist contact information provided, should you require a waiver not to use FedConnect for submitting. All responses must be received by the specified due date and time in order to be considered. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. No proprietary, classified, confidential, or sensitive information should be included in your 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 review of the responses received, pre-solicitation and solicitation notices may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.
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