SOURCES SOUGHT
R -- LAMPOON Clinical Event Adjudication Committee (CEAC) Support Services
- Notice Date
- 6/19/2017
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- 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
- HHSN-NIH-NHLBI-SBSS-2017-250
- Archive Date
- 7/11/2017
- Point of Contact
- Jonathan M. Lear,
- E-Mail Address
-
john.lear@nih.gov
(john.lear@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. The National Heart, Lung, and Blood Institute (NHLBI) does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted. As a result of this sources sought notice, the NHLBI may issue a request for quote (RFQ). There is no solicitation available at this time. However, should such a requirement materialize, no basis for claims against NHLBI shall arise as a result of a response to this sources sought notice or the NHLBI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. The NHLBI is seeking capability statements from all eligible small business concerns under the North American Industry Classification System (NAICS) code 541990 with a size standard $15.0M. Based on the responses received from this sources sought announcement, the proposed acquisition may be solicited as a total small business set-aside. All eligible small business concerns responding to this sources sought announcement must have the capabilities to provide the services as stated below. Background NHLBI and Emory University developed a novel approach to splitting the mitral valve leaflet to prevent a life-threatening complication of transcatheter mitral valve replacement. The procedure, known as "intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow obstruction, or LAMPOON" is performed during the same procedure and immediately before valve implantation. LAMPOON was first performed in a patient in May 2016 at Emory University. Since then, it has been performed approximately ten times. NHLBI is sponsoring a more careful analysis of the LAMPOON procedure, and therefore is sponsoring an Investigational Device Exemption (IDE) study, referred hereafter as Protocol, consisting several participating medical centers. Purpose and Objectives To assure clinical data integrity, the NHLBI must contract with an independent Clinical Event Adjudication Committee (CEAC). The CEAC will be utilized to generate independent confirmation of important endpoints of the Protocol. Tasks to be Performed -The contractor shall form a CEAC consisting of at least three (3) cardiologists including at least two (2) interventional cardiologists to conduct a complete adjudication of the Protocol. -The CEAC shall adjudicate predetermined clinical adverse events (AE) during the Protocol to confirm accurate event classification and ascription to the research procedures. The classifications will apply to the first 30 days after the transcaval procedure, or until first hospital discharge. The specific events include the following: oDeaths, whether cardiovascular or non-cardiovascular oTechnical success, which is the primary endpoint of the protocol, as described in the protocol oMVARC 30-day and 1-year device, procedure, and patient success oProcedure mortality related to LAMPOON and to TMVR oMajor adverse cardiovascular events (MACE) up to 30 days -The CEAC shall determine by consensus or majority vote whether each AE is (1) confirmed, (2) refuted, or (3) insufficient evidence is available to confirm or refute. If the CEAC disputes the sponsor's event classification, the dispute will be resolved by verbal and written communication. -Additionally, the CEAC shall reclassify AEs as needed under one of the following classifications: oClearly related to LAMPOON oPotentially, but not clearly, related to LAMPOON oUnrelated to LAMPOON Period of Performance The estimated period of performance of this contract is five (5) years from date of contract award. Capability Statement / Information Sought Interested parties are expected to review this notice to familiarize itself with the requirements of this project. Failure to do so will be at your firm's own risk. The following information shall be included in the capability statement: -A general overview of the respondents' opinions about the difficulty and / or feasibility of the potential requirement, and any information regarding innovative ideas or concepts. -Information in sufficient details of the respondents' (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information. -The respondents' DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc) pursuant to the North American Industry Classification System (NAICS) code: 541990 with a small business size standard of $15.0M. -Any other information that may be helpful in developing or finalizing the requirements of the potential acquisition. Capability statements must demonstrate experience with similar projects and will be evaluated by the following criteria: -Capability statements must demonstrate past performance in projects involving interventional cardiology. Potential offerors are encouraged to provide a brief description of past projects or protocols they have facilitated in the field of interventional cardiology. Closing Statement Interested qualified small business organizations should submit a tailored capability statement for this requirement, not to exceed five (5) single-sided pages (including all attachments, resumes, charts, etc.) presented in single-space and using a 12-point font size minimum, that clearly details the ability to perform the aspects of the notice described above. All proprietary information should be marked as such. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern's name and address). Responses will be reviewed only by NIH personnel and will be held in a confidential manner. All capability statements sent in response to this sources sought notice must be submitted electronically (via email) to Jonathan Lear, Contracting Officer, at john.lear@nih.gov in either MS Word or Adobe Portable Document Format (PDF), by June 26, 2017 at 5:00PM, EST and must reference synopsis number HHSN-NIH-NHLBI-SBSS-2017-250. All responses must be received by the specified due date and time in order to be considered. 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).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHSN-NIH-NHLBI-SBSS-2017-250/listing.html)
- Place of Performance
- Address: National Institutes of Health / NHLBI, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN04549124-W 20170621/170619234650-d4fd09d347ecb15abd20dd84e1a63574 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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