FBODaily.com | FedBizOpps: SRCSGT | A | Daily Activity Measured with Accelerometry in a clinical trial: Transcatheter Aortic Valve Replacement to Unload the Left ventricle in patients with Advanced heart failure (TAVR UNLOAD)

FBO DAILY - FEDBIZOPPS ISSUE OF JULY 02, 2016 FBO #5335
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A -- Daily Activity Measured with Accelerometry in a clinical trial: Transcatheter Aortic Valve Replacement to Unload the Left ventricle in patients with Advanced heart failure (TAVR UNLOAD)

Notice Date: 6/30/2016
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 Institute on Mental Health, Contracts Management Branch, 6001 Executive Blvd, Rm 8154, MSC 9661, Bethesda, Maryland, 20892-9661
ZIP Code: 20892-9661
Solicitation Number: HHS-NIH-NIDA(AG)-SBSS-16-024
Archive Date: 7/27/2016
Point of Contact: Heather Orandi, Phone: 301-443-6162
E-Mail Address: Heather.Orandi@nih.gov
(Heather.Orandi@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. BACKGROUND The National Institute on Aging (NIA) Laboratory of Epidemiology and Populations Studies (LEPS) has a need for a project entitled "Daily Activity Measured with Accelerometry in a clinical trial: Transcatheter Aortic Valve Replacement to Unload the Left Ventricle Comparing Optimal Heart Failure Therapy to Transcatheter Aortic Valve Replacement to Unload the left ventricle in patients with Advanced heart failure" (TAVR UNLOAD). This is a new requirement, nested in a clinical trial in which patients have advanced heart failure and moderate aortic valve disease, and will allow for the comparison of patients with optimal medical therapy versus patients with optimal medical therapy and transcatheter replacement of the aortic valve. TAVR UNLOAD is a new clinical trial funded through the Cardiovascular Research Foundation. The goal of this study is to examine whether replacement of aortic valve in patients with moderate valvular damage aids in the treatment of congestive heart failure when both conditions occur. While the trial is planned with sites in both Europe and the United States, the follow-up for accelerometry determined endpoints will take place in the United States. This is new work that is currently not part of the grant-funded study. The overall goal of this ancillary study is to estimate the change in daily activity over time, comparing patients with aortic valvular disease and congestive heart failure who are randomized, to either optimal therapy for congestive heart disease or to transcatheter replacement of their aortic valve combined with optimal therapy for congestive heart disease. Currently, there are few trials using accelerometry that longitudinally characterize change in daily activity over the course of the trial. The goals of adding an ancillary study with accelerometry are several-fold. First, the ancillary study would provide data regarding the central question of the trial-over the course of the trial, with ascertainment periods at one (1) month, six (6) months, one (1) year, and two (2) years, will daily activity be greater in subjects who have had their valve replaced via a transcatheter approach? Will sleep quality and indicators of circadian rhythm be better preserved in subjects with congestive heart failure who undergo treatment with aortic valve replacement? The repeated objective monitoring data in the trial will provide specific information on change in activity volume, duration, intensity and distribution that also will allow study of hypotheses regarding the natural history of congestive failure and change in function over time as well as change in function and recovery related to TAVR. Lastly, the ancillary study accelerometry data will allow assessment of whether there is utility in inclusion of objective monitoring within clinical trials, given the many other measurements of functional status included in the trial. PURPOSE AND OBJECTIVES The objectives of this requirement are: 1) compare objectively measured daily activity in subjects with optimally treated advanced congestive heart failure who have been randomized TAVR or no TAVR; 2) to quantify the natural history of decline and recovery in objectively measured activity following TAVR in subjects with moderate aortic stenosis with advanced congestive heart failure; 3) to quantify the natural history of the relationship between objectively measured daily activity and congestive heart failure in patients undergoing TAVR; and 4) to quantify natural history of the relationship between objectively measured daily activity and moderate aortic stenosis with advanced congestive heart failure. PROJECT REQUIREMENTS / SCOPE OF WORK This study calls for performing the following activities for two (2) years: • Defining the study population o As directed by the Government, the resultant Contractor shall share a list of all clinical centers for the trial. Identify high volume centers for recruitment. These high volume centers will be targeted for accelerometry with numbers extending from this base if necessary. • Finalize protocols o A study coordinator for this ancillary study will be identified at each of the study centers. A trainer from LEPS will review the preliminary protocol with these coordinators and will finalize the study protocol based on feedback from the coordinators. As part of that protocol, serial numbers for each accelerometer deployed will be recorded and battery level will be noted. o Actigraph accelerometers will be used over the entire course of the study to assess activity measures including intensity, duration, and distribution. Accelerometers objectively assess activity with minimal burden and good compliance. The monitors will be worn on the wrist during the data collection to enhance acceptability of the protocol. o Participants will be required to complete a log indicating their sleeping and waking times during each period of accelerometry. • Protocol for mailing of accelerometers by participants to the study coordinator o Jointly with LEPS investigators, define a protocol by which accelerometers would be returned to the clinic center by mail, including plans for following up with nonrespondents. • Data management o Provide data collection forms for monitor tracking, refusal tracking, complaint tracking, and relevant medical events. All data from these sources shall be entered into a single database. The resultant Contractor shall institute measures to minimize data entry errors and time spent correcting the data. o Upload the data into the files at the Coordinating Center for the TAVR UNLOAD trial. The Coordinating Center will be responsible for uploading data to the Interdisciplinary Studies of Aging Section of the Laboratory of Epidemiology and Population Sciences for analysis. o Raw data from the accelerometers will be uploaded at the clinical sites and sent to the Study Coordinating Center and then to LEPS for processing, transformation, and calculation of standardized variables. The calculated variables will be transmitted back to the TAVR UNLOAD Coordinating Center where they will be joined to the master dataset. o The data management task at the Coordinating Center will consist of downloading data from the accelerometers and securely transferring the data to the NIA LEPS. The data management task will also respond to quality control queries from NIA LEPS and will provide requested clinical data to NIA LEPS. The resultant Contractor shall be responsible for protection of any personally identifiable information (PII) that is obtained from participants. No PII is required in the transfer of accelerometer data to NIA LEPS. De-identified raw data files will reside at the NIA as well as at TAVR UNLOAD Coordinating Center. • Data analysis o The resultant Contractor shall guarantee that data needed for analytic papers to complement the accelerometer files will be available to the NIA LEPS analysis center and colleagues for papers to be written from the data. TAVR UNLOAD investigators and NIA investigators will be included in papers published from this work. All work under this task will follow TAVR UNLOAD and NIA publication principles for submission of written work. o Once data collection is complete, the NIA LEPS will coordinate sharing of the calculated standardized variables from the accelerometry data created at LEPS with the TAVR UNLOAD data center. The resultant Contractor will provide expertise and collaborate in the preparation of all reports and manuscripts. o The resultant Contractor, with LEPS, will conduct hypotheses testing and draft reports or manuscripts with sharing of appropriate data as requested by LEPS. The resultant Contractor will combine accelerometer data with clinical data from the TAVR UNLOAD Study. For this purpose, standard, statistical, and epidemiologic methods will be used. Reports and deliverables Quarterly Progress Reports to include the description of the work performed during the reporting period; tables for assessment of sample for participants in the study two (2) weeks after study award; finalized questionnaire for administration over the telephone four (4) weeks after study award; monthly transmission of data from de-identified acclerometers with personally identifiable information removed; transmission of de-identified data set for analysis of data to address hypotheses eleven months after study award; and a Final Progress Report to include a summary report on the completion of the study at the end of the contract period will be required. Anticipated period of performance The anticipated period of performance is for two (2) years. The estimated time frame for award is on/or about May 2017. Other important considerations The Government is expected to use procedures in FAR Part 15. The North American Industry Classification System (NAICS) code is 541712 with a size standard of 1,000 employees. Capability statement and information sought: a. Capability Statement - Respondents to this notice must provide, as part of their response, a capability statement to include the following: (1) information regarding 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 as described above; (c) prior completed projects of a similar nature; (d) corporate experience and management capability; and, (e) examples of prior completed Government contracts, references, and other related information; (2) respondents' DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc.) pursuant to the applicable NAICS code; and, (3) any other information that may be helpful in developing or finalizing the acquisition requirement. b. Information Submission Instructions - Respondents should provide responses accordingly: (1) submit information both electronically and by mail. No telephone or facsimile responses will be accepted; (2) format capability statements using Microsoft Word or Adobe PDF including attachments, resumes, charts, etc. Use single space, 12 font minimum and 8 ½ x 11 size paper; (3) organize material in such a manner that clearly identifies and address capability requirements and provide an executive summary; (4) capability statement should not exceed ten (10) single sided pages including references; (5) respondents must send two (2) original copies via mail and one electronic copy via email; (6) RESPONSES SHOULD BE RECEIVED NO LATER THAN July 12, 2016 at 4:00 p.m. LOCAL TIME; (7) include respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses; and (8) send responses to this notice via email to Heather.Orandi@nih.gov. The original statements mailed using the U.S. Postal Service should be sent to ATTN: Heather Orandi, National Institutes of Health, Office of Acquisitions - NIDA Neuroscience COAC, NIA R&D Contracts Management Section, 6001 Executive Boulevard, Room 8154, MSC 9661, Bethesda, MD 20892-9661. If using a courier service such as the UPS, Federal Express, etc., change the City, State and Zip Code to Rockville, MD 20852. (Please be aware that the U.S. Postal Service's "Express Mail" DOES NOT deliver to the Rockville, Maryland address.) 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 as an adequate response 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/NIMH/HHS-NIH-NIDA(AG)-SBSS-16-024/listing.html)
Place of Performance: Address: Rockville, Maryland, United States
Record: SN04168028-W 20160702/160630235637-d80dd845984b3e4af80704b1a6c1f9fc (fbodaily.com)
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A -- Daily Activity Measured with Accelerometry in a clinical trial: Transcatheter Aortic Valve Replacement to Unload the Left ventricle in patients with Advanced heart failure (TAVR UNLOAD)