SOURCES SOUGHT
A -- Pumps for Kids, Infants, and Neonates (PumpKIN) Clinical Trial
- Notice Date
- 10/21/2010
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except 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-HV-12-03
- Archive Date
- 11/20/2010
- Point of Contact
- Roxane Burkett, Phone: 301-435-6671
- E-Mail Address
-
burkettr@mail.nih.gov
(burkettr@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Introduction 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 response to this 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 NAICS code 541712 should not submit a response to this notice. Background The NHLBI is seeking a small business with the ability to serve as a Data and Clinical Coordinating Center (DCCC) for a new five-year program, Pumps for Kids, Infants, and Neonates (PumpKIN) clinical trials. The purpose of the program is to explore the potential benefit of therapy offered by novel pediatric circulatory support devices to infants, neonates, and young children (<25 kg) with congenital and acquired cardiovascular disease who experience cardiopulmonary failure and circulatory collapse. The trials are intended to provide clinical evidence to be used in Humanitarian Device Exemption applications to the U.S. Food and Drug Administration (FDA) for regulatory approval of the devices. As the PumpKIN DCCC, the contractor will have the overall responsibility for the operation of the trials and will provide the necessary administrative guidance, oversight, and support to achieve the trials’ objectives. The DCCC will be responsible for finalizing the clinical protocols, manual of operations, and monitoring procedures, address other clinical issues, and run the Investigational Device Exemption (IDE) trials according to the planned timeline. NHLBI currently funds four contractors to complete the necessary pre-clinical development, testing, evaluation, and manufacturing of their devices for the PumpKIN clinical trial. Each of these four PumpKIN pre-clinical contractors will work with the DCCC and a Protocol Development Committee consisting of the other pre-clinical contractors, NHLBI staff, and other NHLBI-appointed experts to develop and finalize their IDE clinical trial designs and protocols. The clinical trial plans and protocols are expected to be submitted by the PumpKIN pre-clinical contractors to the FDA as part of their IDE applications during the third year of the current PumpKIN program with approval targeted by the end of Year 3. The DCCC will be responsible for providing each pre-clinical contractor with the protocol that is to be submitted with their IDE application to the FDA for their device. The PumpKIN pre-clinical contractors will provide regulatory and device technical support throughout the clinical study. Initially, these activities will be funded during the pre-clinical contracts. After completion of the pre-clinical contracts, funds for such activities will be provided through subcontracts under the DCCC PumpKIN contract. Project Requirements The DCCC shall conduct all aspects (administrative guidance, oversight, and support) of the PumpKIN clinical trials. The DCCC shall have overall responsibility for the operation of the clinical trials which includes clinical site coordination, data collection, management, and analyses, and preparation of clinical regulatory documents in support of an Investigation Device Exemption (IDE) clinical trial. The DCCC shall 1) Work with NHLBI to identify competent clinical sites for the trials and finalize subcontracts for the selected clinical sites; 2) Arrange steering committee, protocol review committee, and protocol development committee meetings and arrange data safety and monitoring board activities; 3) Coordinate protocol and manual of procedures writing activities; 4) Develop and distribute clinical trial forms, case report forms, and other reporting tables and figures; 5) Create clinical trial logos, newsletters, brochures, posters, and checklists; 6) Perform clinical regulatory activities including: obtaining research agreements and IRB approvals with each of the clinical sites, monitoring device accountability records by IDE sponsors, obtaining investigator agreements, monitoring clinical sites, informing investigators of plans and study-related reports, and providing clinical reports to the FDA and IRBs (See http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYour Device/InvestigationalDeviceExemptionIDE/ucm046702.htm#resofspofor for further information on IDE responsibilities.) 7) Establish working groups to standardize protocols and establish quality standards for clinical data to be collected; 8) Develop a secure web-based data entry system for data collection and distribution of information to the clinical sites; 9) Develop a training plan and train the clinical site and core laboratories for all aspects of the PumpKIN program; 10) Develop a data analysis plan for the trials and develop a complete data set distribution plan; 11) Manage clinical sites to achieve the goals of the PumpKIN clinical trials. Activities related to this requirement include monitoring patient recruitment, maximizing patient adherence and retention; and auditing the participating clinical sites to maintain quality control; 12) Prepare and distribute technical and statistical reports; 13) Review data to ensure scientific validity and to ensure privacy policies are being properly followed; 14) Organize and maintain IRB approvals, informed consents, and other relevant documents; 15) Collaborate with the FDA by preparing and submitting required reports/data to the FDA; 16) Facilitate communications among all organizational trial components; 17) Maintain the computer system, secure trial database, and software needed for the storage and analysis of all trial data (including biological specimens) collected from all PumpKIN clinical sites and core laboratories; 18) Work with the steering committee to establish a publications and presentations policy and infrastructure for review/prioritization of manuscripts and abstracts; 19) 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; and 20) Analyze data and prepare trial reports, create a public dataset and data sharing plan, and create and distribute all final reports to the NHLBI and FDA. Capability Statement Small business concerns that believe they possess the capabilities necessary to undertake this study should submit complete documentation of their capabilities to the Contract Specialist. The capabilities statement should 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 PumpKIN 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. All capability statements sent in response to this Sources Sought Notice must be submitted electronically (via email) to Roxane Burkett, Contract Specialist, at burkettr@nhlbi.nih.gov and Dr. Tim Baldwin, Project Officer, at baldwint@nhlbi.nih.gov in either MS Word or Adobe Portable Document Format (PDF), within 15 calendar days of the date of this announcement. 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 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. The solicitation release date is pending. The Government intends to negotiate one (1) cost-reimbursement contract for a period of five years with an approximate award date of January 15, 2012.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-SBSS-HV-12-03/listing.html)
- Place of Performance
- Address: Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Office of Acquisitions, 6701 Rockledge Dr, Room 6125, MSC 7902, Bethesda, Maryland, 20892-7902, United States
- Zip Code: 20892-7902
- Zip Code: 20892-7902
- Record
- SN02315131-W 20101023/101021234356-65f97b084d8a587c3c6dbf7a4ab4eed5 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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