SOLICITATION NOTICE
R -- Objective Physical Activity Monitoring in Percutaneous Coronary Intervention Patients
- Notice Date
- 9/24/2015
- Notice Type
- Presolicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support/Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, Maryland, 20892
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SSSA-NOI-2015-914
- Archive Date
- 10/10/2015
- Point of Contact
- Hunter A. Tjugum, Phone: 301 435 8780
- E-Mail Address
-
hunter.tjugum@nih.gov
(hunter.tjugum@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institute on Drug Abuse (NIDA), Station Support Contracts and Simplified Acquisitions Branch (SS/SA) on behalf of the National Institute on Aging (NIA) at the National Institues of Health (NIH) intends to negotiate and award a contract without providing for full and open competition (Including brand-name) to Columbia University Medical Center, located at 154 Haven Avenue, 2nd floor, New York, NY 10032 Objective Physical Activity Monitoring in percutaneous Coronary Intervention Patients. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541990 with a Size Standard of $15.0 M. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-83-1, September 5, 2014. This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($150,000). STATUTORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13-Simplifeid Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. GENERAL INFORMATION 1. Title: Objective Physical Activity Monitoring in Percutaneous Coronary Intervention Patients 2. Background Information: The Laboratory of Epidemiology and Population Science (LEPS) is contained within the Intramural Research Program (IRP) of the NIA and seeks to plan, conduct, and direct epidemiology, demography, and biometry programs relevant to the mission of the NIA. LEPS collects and analyzes data regarding the distribution of the aged by such categories as sex, race, socioeconomic, and demographic characteristics and serves as a focal point for these data; and plans, initiates, coordinates, and analyzes national and international epidemiologic longitudinal studies and studies of special populations. LEPS recommends priorities and develops epidemiologic studies of specific diseases and conditions affecting the aged in collaboration with NIA staff and other Institute Centers and scientific organizations. 3. Purpose or Objective: The purpose of this project is to provide contractor support to LEPS that is engaged in a pilot study in which subjects are monitored via wrist worn accelerometers for objective physical activity while undergoing Percutaneous Coronary Intervention. The accelerometers have increased capabilities for collection of information on the intensity, duration, patterns, and even type of movement. This requirement will work on completing a pilot test that uses accelerometry to assess function in a frail, free-living population undergoing the major medical intervention of a clinical trial. This phase of testing will assess the utility of accelerometry to capture clinically relevant change in patterns of daily activity by collecting longitudinal data on persons with coronary artery disease who will undergo elective percutaneous coronary intervention (PCI). 4. Period of Performance: September 30, 2015 through September 29, 2016 CONTRACTOR REQUIREMENTS (SCOPE OF WORK) Contractor will collect pilot data on objective physical activity monitoring in patients who undergo PCI. The requirement includes recruitment of participants and data collection. Up to 100 participants will be recruited for this project. It is anticipated that all will be at least age 65 or older. Recruitment will cover the range of presenting disease severity. The data from each monitor will be downloaded to a dedicated computer and backed up immediately. These data will be transmitted to the LEPS for quality control review. Specifically, the contractor will recruit participants and collect data over an extended period of follow-up, based on the participants' disease status and the intervention assignment in the existing clinical trial of which participants are already a part. Data collection shall be based on previous data collected on use of the ACTIV accelerometer used by subjects undergoing Transcatheter Aortic Valve Replacement (TAVR). Data collection during patient recovery (or follow-up) will vary dependent on the complexity of the patients' medical conditions at the time of the PCI (multi-morbidity, congestive heart failure, frailty, advanced age) and will also vary with the complexity of the intervention (chronically totally occluded coronary artery lesions, need for hemodynamic support, calcifications that require atherectomy, or multivessel PCI). A minimum of three months of follow-up time, during which participants will wear the accelerometers is required. The digital data from the acclerometry will be used by LEPS to create variables to characterize periods of physical activity, sedentariness, and sleep after PCI over the next three months. The Contractor will need to acquire ActiGraph accelerometers as part of this potential requirement. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10-Market Research, specifically the review and evaluation of the responses to the sources sought notice published in the FedBizOpps on August 28, 2015, under notice number HHS-NIH-NIDA-SSSA-SS-2015-831, Objective Physical Activity Monitoring in PCI patients. Columbia University Medical Center has both the expertise, facilities and experience for performing the requirements of this project. This requirement is closely related to the work performed under purchase order number HHSN270201100704P in which CU developed a specific type of database that needs to used to maintain consistency of data collection in the subject research phase. Because of the related expertise and knowledge of the project Columbia University is the only known source with the capability of provide the services of this project. CLOSING STATEMENT This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include a technical proposal, cost-price proposal, the period of performance, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by September 25, 2015, 4:30 PM Eastern time and must reference solicitation number HHS-NIH-NIDA-SSSA-NOI-2015-914. Responses may be submitted electronically to Mr. Hunter Tjugum, Contracting Specialist at hunter.tjugum@nih.gov. Fax responses will not be accepted. "All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency."
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