SOURCES SOUGHT
A -- LAMPOON IDE Enrollment Sites
- Notice Date
- 3/27/2017
- 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
- HHSN-NIH-NHLBI-SBSS-2017-100
- Archive Date
- 4/26/2017
- 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 proposals (RFP). 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 541711 with a size standard 1,000. 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 Transcatheter Mitral Valve Replacement (TMVR) is an option to treat mitral valve failure when no surgical options exist. In as many as half of patients, TMVR can cause life-threatening blockage of the left ventricle by displacing the existing mitral valve leaflet. Investigators at the National Heart Lung and Blood Institute (NHLBI), Emory University, and Henry Ford Hospital developed a novel procedure to prevent this life-threatening blockage. The procedure, known as Intentional Laceration of the Anterior Mitral leaflet to Prevent left ventricular Outflow Obstruction (aka. LAMPOON), herein referred to as the Procedure is a new catheter technique to split the anterior mitral leaflet and prevent iatrogenic left ventricular outflow tract obstruction immediately before TMVR. It utilizes a Transcatheter Heart Valve (THV) device marketed for implantation in the aortic or pulmonic positions off-label. The THV device has been approved for investigational use in human subjects by the FDA-reference IDE License G160239. Already, the Procedure has been used successfully in a small number of patients. Purpose and Objectives The NHLBI's Division of Intramural Research (DIR) is sponsoring a careful investigation of the Procedure in patients through a national clinical trial governed by Identifier NCT30151941, Study Number 17-H-N032 (herein referred to as Protocol). The protocol requires the participation of thirty (30) human subjects all of which must be enrolled through one of the participating enrollment sites comprised solely of structural heart disease programs located in the United States. It is neither advisable nor feasible for NHLBI to conduct the Protocol on its own; therefore, the NHLBI needs other structural heart disease programs with greater access to the target patient population to act as enrollment sites and carry out the Protocol. The objective of this project is to provide financial support for up to eight participating enrollment sites to perform its responsibilities in the Protocol and for certain costs incurred from Protocol-related activities for up to thirty (30) total patients. The purpose of the Protocol is to test the efficacy of the Procedure in patients who have no good options to treat their mitral valve failure using heart valve devices designed to implant in the aortic valve position. Tasks to be Performed 1.1.Tasks The Contractor shall furnish all necessary personnel, material, supplies and facilities not otherwise provided by the Government to assume all the duties and responsibilities of an enrollment site for the Protocol. The Contractor shall adhere to Good Clinical Practice (GCP) guidelines and applicable federal regulations related to significant risk medical device research (IDE). The Contractor shall cooperate with site monitors provided by the Government. The Contractor shall perform the following specific tasks and responsibilities in accordance with the Protocol: 2.1.1.Task 1. Screen/Enroll Human Subjects (Up to 24 months from time of Award) Contractor shall identify potential human subjects (candidates) for the Protocol. •Contractor shall perform a clinical evaluation (screening) of the candidates including but not limited to a transesophageal echocardiogram and contrast-enhanced, gated cardiac CT. •Contractor shall review results from the screenings and consult with the Government on the candidates' eligibility. •Contractor shall offer participation in the Protocol to only those candidates deemed eligible by the Government. •Contractor shall enroll the candidate into the Protocol by obtaining the candidate's consent. (All screening and human subject enrollment shall occur within the first two years of the contract). 2.1.2.Task 2. Conduct Baseline Assessment •Contractor shall conduct a baseline assessment for each enrolled candidate (subject) no more than 30 calendar days prior to performing the Procedure on the subject. (Reference Attachment 1, Time and Events Schedule and Attachment 2, Visit Schedule for assessment details and schedule). 2.1.3.Task 3. Perform Procedure •Contractor shall perform the Procedure on each subject in strict adherence to the instructions provided in the Protocol and/or otherwise provided through trainings performed by the Government for the Contractor. 2.1.4.Task 4. Conduct Endpoint Assessments •Contractor shall perform endpoint assessments (clinical evaluations) on each subject at various intervals throughout the subjects' post-procedure/recovery period. (Reference Attachment 1, Time and Events Schedule and Attachment 2, Visit Schedule for assessment details and schedule). 1.2.Reporting Requirements The Contractor shall adhere to the reporting requirements explained herein. All data and reports furnished by the Contractor in association with the Protocol shall be subject to inspection by the Government; therefore, the Contractor shall provide access to its data and reports to the Government upon the Government's request. 1.2.1.Case Report Form (CRF) Completion 1.2.1.1.Contractor shall complete CRFs for each subject. Contractor's Principal Investigator (PI) shall ensure the accuracy, completeness, and timeliness of the data reported in the subject's CRF. Source documentation supporting the CRF data shall indicate the subject's participation in the study and document the dates and details of study procedures, AEs, and subject status. 1.2.1.2.Contractor's PI or designated representative shall complete the CRF screens after information is collected on the same day that a subject is seen for an examination, treatment, or any other study procedure, but no more than five days post procedure. An explanation shall be given for all missing data. 1.2.1.3.Contractor's PI shall sign and date the Investigator's Statement at the end of the CRF to endorse the recorded data. 1.2.2.Adverse Event Reporting 1.2.2.1.Contractor shall record and report all Protocol-related adverse events witnessed by Contractor. oThe Contractor shall record adverse event recording on Day (0) of the Procedure and shall continue through the last endpoint assessment. New events or conditions present at baseline that increase in severity shall be recorded, evaluated and reported on the case CRF. oThe Contractor shall report, once the subject has completed the 30-day follow up, only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) to the Government. oThe Contractor's PI shall report adverse events and adverse device effects to its respective IRB or other regulatory body according to its reporting requirements. oContractor shall make available source documents and adverse event case report forms for review by the Government during scheduled monitoring visits. 1.2.2.2.Serious Adverse Events (SAEs) 1.2.2.2.1.Contractor shall report all serious adverse events to the Government immediately but no later than three working days from the event. 1.2.2.3.Unanticipated Adverse Device Effects (UADE) 1.2.2.3.1.Contractor shall report UADEs to the Government and its IRB immediately but no later than 10 working days after the Contractor's PI learns of the event. [21 CFR 812.150] 1.2.2.3.2.The Contractor shall report UADEs via telephone as well as on the adverse event section of the case report form. 1.2.2.4.Deaths 1.2.2.4.1.Contractor's PI shall notify the Government immediately of a subject's death. It shall notify the Government within three working days whether the death was device-related or related to a clinical condition. 1.2.2.4.2.Contractor shall record a subject's death on the CRF. 1.3.Inspection and Acceptance 1.3.1.The Contract shall provide the Government access for the review of its reports, including but not limited to source documentation and CRFs, for completion and accuracy. 1.3.2.The Contractor shall provide the Government access to its facilities for monitoring its activities and to ensure compliance with all rules, regulations and guidelines instituted in the Protocol. 1.4.Government Responsibilities The Government will provide training, electronic case report forms and data management, site monitoring, protocols, and data coordinating services to facilitate Contractor's work. 2.Reference Materials 2.1.Attachment 1, Time and Events Schedule 2.2.Attachment 2, Visit Schedule for assessment details and schedule. 2.3.ClinicalTrials.gov Identifier: NCT03015194 https://clinicaltrials.gov/ct2/show/NCT03015194?term=NCT03015194&rank=1 2.4.21 CFR 812.150: Investigational Device Exemptions, Subpart G- Records and Reports http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=1058555cdb522297b006c6e27ee9c62a&mc=true&n=sp21.8.812.g&r=SUBPART&ty=HTML 2.5.Good Clinical Practice (GCP) Guidelines https://www.fda.gov/downloads/drugs/guidances/ucm073122.pdf 2.6.IDE Enforcement of Good Clinical Practices (GCP) Regulations https://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/investigationaldeviceexemptionide/ucm051363.htm 2.7.FDA reference IDE License G160239 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: 541711 with a small business size standard of 1,000. -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: -The capability statement provides evidence of the offeror's past performance in TAVR and TMVR. Specifically, it cites the total number of TMVR/LAMPOON-eligible patients the offeror received and total number of TMVR/LAMPOON procedures the offeror performed within the past twelve (12) months. Additionally, the capability statement includes the estimated number of TMVR / LAMPOON-eligible patients the offeror expects to receive and the estimated number of TMVR/LAMPOON procedures the offeror expects to perform over the next twelve (12) months. -The capability statement describes the experience and qualifications of personnel who will be performing the work. It includes resumes for all personnel proposed that demonstrate the knowledge and depth of experience necessary to perform the work. -The capability statement describes the proposed facilities / environment where all work will be performed. It lists all equipment the offeror intends to use to execute the work requirements and provides evidence of the offeror's access to such equipment. Closing Statement Interested qualified small business organizations should submit a tailored capability statement for this requirement, not to exceed ten (10) 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 April 11, 2017 at 3:00PM, EST and must reference synopsis number HHSN-NIH-NHLBI-SBSS-2017-100. 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-2017-100/listing.html)
- Place of Performance
- Address: National Institutes of Health / NHLBI, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN04448424-W 20170329/170327234641-d8c0132bf4d0cec2d1919ab30c216e4d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |