SOLICITATION NOTICE
R -- Studies of the Natural History and Pathogenesis of Spondyloarthritis
- Notice Date
- 8/18/2016
- 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 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
- NHLBI-CSB-AR-2016-264-KEW
- Archive Date
- 9/11/2016
- Point of Contact
- Kyle Wisor, Phone: 3014023670, Lisa Portner, Phone: 3014350326
- E-Mail Address
-
Kyle.Wisor@nih.gov, Lisa.Portner@nih.gov
(Kyle.Wisor@nih.gov, Lisa.Portner@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 Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA) on behalf of the National Institute of Dental and Craniofacial Research (NIDCR) intends to negotiate and award a Purchase Order without providing for full and open competition (Including brand-name) to Childrens National, 111 Michigan AVE, NW Washington, DC 20010 for Pediatric Rheumatology professional services. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541990, All Other Professional, Scientific and Technical Services, with a Size Standard of $15M. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-89 effective 15 AUG 2016. 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 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart FAR 6.302-1-Only one responsible source and no other supplies or services will satisfy agency requirements 41 U.S.C. 253(c)(1). DESCRIPTION OF REQUIREMENT Background The National Institutes of Health (NIH) is the nation's leading medical research agency, and the primary Federal agency conducting and supporting medical discoveries that improve people's health and save lives. The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases; the training of basic and clinical scientists to carry out this research; and the dissemination of information on research progress in these diseases. The Studies of the Natural History and Pathogenesis of Spondyloarthritis protocol 11-AR-0223 has been active for over 5 years. The purpose of the protocol is to follow Spondyloarthritis patients longitudinally to determine predictors of axial disease (spine involvement). To this end, patients are followed every 6 months to a year with detailed clinical and laboratory evaluation and whole body MRI. This requirement is to establish a treatment protocol and evaluate effectiveness of novel agents in this patient cohort. Purpose and Objectives The purpose of this contract is to recruit a contractor to continue work on protocol 11-AR-0223, "Studies of the Natural History and Pathogenesis of Spondyloarthritis". The objective of this protocol is to accelerate and establish a treatment protocol for Spondyloarthritis patients. Period of Performance Base Year: August 31, 2016 - August 30, 2017 Option Year 1: August 31, 2017 - August 30, 2018 Option Year 2: August 31, 2018 - August 30, 2019 Project Description Tasks: The contractor shall 1. Gather patient information from questionnaires, general physical examinations, joint and entheseal examinations, spine, neck, and chest measurements and whole body MRI; 2. Perform clinical evaluation and formulate a management plan for Spondyloarthritis patients; 3. Input clinical data on the patient electronic database; 4. Analyze cross-sectional and longitudinal data from this protocol; 5. Evaluate patient laboratory results, analyze findings and write manuscripts; 6. Follow-up with patients long-term; 7. Contractor will be required to work eight (8) hours a week Monday through Friday, 416 total on the year. Contractor Requirements The contractor shall have a medical degree with training in Pediatric Rheumatology and at least five (5) years of experience in the NIH Clinical Center. Expertise with pediatric clinical protocols that focus on Spondyloarthritis' patients is also required. Proficiency in scientific abstract preparation and presentation at regional and national meetings is essential. Government Requirements NIAMS Clinicians lead and oversee the investigation that takes place under the clinical protocol. Pediatric patients have already been enrolled by the Institute for this protocol. Other Important Considerations None 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, NHLBI-CSB-AR-2016-232-KEW, published in the FedBizOpps on July 25th, 2016; no other vendors provided a capability statement. Only one source is available: The uninterrupted continuation of protocol 11-AR-0223 depends on Children's National Medical Center faculty's clinical skills needed for the evaluation of these patients. Dr. Srinivasalu with Children's National is the only contractor capable of performing the required services. Her services are unique because she has been involved in this protocol since its inception, and has contributed to protocol amendments, continuing renewals, helped create case report forms (CRFs), and formulated data points and clinimetrics to be captured in the study. During the 5 years this protocol has been active, Dr. Srinivasalu has been responsible for clinical evaluation, gather of patient information, and formulating a management plan for these patients. Furthermore, she helped create an electronic database for the clinical data and analyzed cross-sectional and longitudinal data from this protocol. As such, Dr. Srinivasalu is the only responsible source capable of providing the required services. 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: 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 by 8/27/16 and must reference number NHLBI-CSB-AR-2016-264-KEW. Responses may be submitted electronically to Kyle Wisor, Kyle.Wisor@nih.gov, or by U.S. mail to the National Heart, Lung, and Blood Institute, Office of Acquisitions, COAC Services Branch,6701 Rockledge Drive, Suite 6150B, Bethesda, MD 20892-7902, Attention: Kyle Wisor. Fax responses will not be accepted. "All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency."
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-CSB-AR-2016-264-KEW/listing.html)
- Place of Performance
- Address: 111 Michigan Ave, Washington, District of Columbia, 20010, United States
- Zip Code: 20010
- Zip Code: 20010
- Record
- SN04231698-W 20160820/160819001150-91ef78bcb3ed0ea124154a8b76fb8a76 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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