SOLICITATION NOTICE
B -- Recruitment, Clinical Support, Study Data for Sickle Cells Disease and Leg Ulcers Clinical Research Study
- Notice Date
- 8/13/2015
- Notice Type
- Presolicitation
- NAICS
- 622110
— General Medical and Surgical Hospitals
- 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-CSB-(HG)-2015-210-DLM
- Archive Date
- 9/4/2015
- Point of Contact
- Dorothy Maxwell, Phone: 301-435-0352
- E-Mail Address
-
maxwelld@mail.nih.gov
(maxwelld@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION: THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR A PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The National Heart, Lung, and Blood Institute (NHLBI) Office of Acquisition (OA) intends to negotiate and award a purchase order on a noncompetitive sole source basis to Montefiore Medical Center, 111 E. 210th Street, Bronx, New York 10467, to provide recruitment, clinical Support, study data for Sickle Cells Disease and Leg Ulcers INSIGHTS Study in collaboration with the National Institute of Health (NIH), National Human Genome Research Institute (NHGRI). The Study has already been developed and approved by the NHGRI Institutional Review Board (IRB), Protocol Study Number: 14-HG-0125. Clinical Trial Number: NCT02156102. Background : The sole source determination is based on the fact that the National Institute of Health (NIH) mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. The National Human Genome Research Institute (NHGRI), mission has expanded to encompass a broad range of studies aimed at understanding the structure and function of the human genome and its role in health and disease. The National Human Genome Research Institute's Division of Intramural Research plans and conducts a broad program of laboratory, clinical and social science research to translate genomic and genetic research into a greater understanding of human genetic disease, and to develop better methods for the detection, prevention and treatment of heritable and genetic disorders Social & Behavioral Research Branch (SBRB) has the overarching and broad objective to investigate social and behavioral factors that facilitate the translation of genomic discoveries for health promotion, disease prevention, and health care improvements. The Bonham Lab is involved in studying the factors associated with sickle cell disease and leg ulcer formation. There is a need to study the risk factors, including genetic, microbial, psychosocial, and clinical indicators that are associated with the development and healing of leg ulcers in patients with sickle cell disease. In order to advance the work on this issue of health disparity, investigators will be collecting clinical, microbiome, laboratory, and psychosocial factors. Purpose and Objectives : The purpose of this contract is research collaboration, including recruiting participants, data collection services, and clinical support, for the INSIGHTS Study. Under this purchase order, the contractor shall recruit, consent, screen, and examine study participants to collect data for the study. NHGRI will partner with Montefiore Medical Center in order to collect data for this study, investigators will partner with an organization with a solid background in clinical research with the New York City area. The investigators believe this purchase order with the Montefiore Health System fulfills the needs of this study and will key and essential results. Period of Performance : Base Year: 12 Months September 2015 to September 2016 Option Year 1: Option Year 2: Option Year 3: Justification : This is an approved Clinical Study: Insights into Microbiome and Environmental Contributions to Sickle Cell Disease and Leg Ulcers Study (INSIGHTS Study). The goal of the study is to integrate research on microbiome, genomic, clinical, environmental, and psychosocial factors to understand sickle cell disease clinical variation and the formation and healing process of individuals living with leg ulcers. The project investigates these four distinct areas of research-genomic, clinical, environmental, and psychosocial-to offer an integrative theory as to why SCD patients develop leg ulcers and how to intervene to reduce severity and facilitate healing. The Bonham is collaborating with a health care system and associate investigator to recruit and collect data from 100 participants with sickle cell disease for the INSIGHTS study, in which Montefiore Medical Center has proven to be a significant partner to collaborate with. Contractors Requirements : Task 1: Medical Advisor: The contractor shall act as a medical advisor for the INSIGHTS protocol. Task 2: Establishing a data collection site: The contractor shall collaborate with the Bonham Lab and Koehly Lab as a collection site for the INSIGHTS study and the Family Share Sickle Cell Disease Study. Task 3: Consultation of data collected and other aspects of the study: To provide consultation as the medical advisor on various aspects of the study; (e.g. design revisions, clinical database, statistical analyses of the data, etc.). Required Reports/Deliverables: • Contractor shall participate in INSIGHTS Study as an Associate Investigator; • Contractor shall screen and recruit study participants; • Contractor shall recruit 100 participants at their site; • Contractor shall collect, examine, and manage data from study participants; • Contractor shall submit all biological samples to NIH and the Bonham Lab; • Contractor shall submit all survey data collected to NIH and the Bonham Lab; and • Contractor shall provide status reports and documentation procedures as agreed upon with the Principal Investigator. Regulatory Authority : This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart 13.106-1(b) Soliciting from a single source. Additional Information : Industry Classification (NAICS) Code is 622110, General Medical and Surgical Hospitals with size standard in dollars $38.5M Per Annum. The acquisition is being conducted under FAR Part 13, simplified acquisition procedures, therefore the requirements of FAR Part 6 B Competitive Requirements are not applicable (FAR Part 6.001). The resultant Contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-83 (August 5, 2015). This requirement is under the SAT of $150,000.00. 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: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), 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 no later than 7:30 a.m. Eastern Standard Time (EST), August 20, 2015; and must reference synopsis number HHS-NIH-NHLBI-CSB-(HG)-2015-210-DLM, may be submitted to the National, Heart, Lung and Blood Institute, COAC Services Branch, Office of Acquisitions, Office of Management, 6701 Rockledge Drive, Suite 6149, Bethesda, Maryland 20892-7902, Attention: Dorothy Maxwell. Response may be submitted electronically to maxwelld@mail.nih.gov. Faxes will not be accepted. Responses will only be accepted if dated and signed by an authorized company representative. "All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency."
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-CSB-(HG)-2015-210-DLM/listing.html)
- Place of Performance
- Address: Contractor's Location, United States
- Record
- SN03838625-W 20150815/150814000635-e83f53c1478d88c9f6957cf5064ec926 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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