SOLICITATION NOTICE
Q -- Enzymology and Biological Testing for Congenital Disorders of Glycosylation for the Undiagnosed Diseases Program
- Notice Date
- 6/6/2013
- Notice Type
- Presolicitation
- 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 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(HG)-2013-173-MKL
- Archive Date
- 6/26/2013
- Point of Contact
- Melissa K. Lombardo, Phone: (301) 435-0370
- E-Mail Address
-
ml363x@nih.gov
(ml363x@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION : THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR COMPETITIVE PROPOSALS. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The National Heart, Lung, and Blood Institute (NHLBI) Office of Acquisitions (OA), on behalf of the National Human Genome Research Institute (NHGRI), intends to negotiate and award a purchase order on a sole source, noncompetitive basis to Emory University School of Medicine, Department of Human Genetics, 2165 North Decatur Road, Decatur, Georgia 30033, to provide a comprehensive study of cellular glycomics, including N-linked, O-linked, and free glycomics, for patients within the National Human Genome Research Institute (NHGRI), Undiagnosed Diseases Program (UDP). 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 National Human Genome Research Institute (NHGRI), Undiagnosed Diseases Program (UDP) is a trans-National Institutes of Health (NIH) initiative that focuses on the most puzzling medical cases referred to the NIH Clinical Center in Bethesda, MD. It was organized by the National Human Genome Research Institute (NHGRI), the NIH Office of Rare Diseases Research (ORDR), and the NIH Clinical Center. Many medical specialties from other NIH research centers and institutes contribute the expertise needed to conduct the program, including endocrinology, immunology, oncology, dermatology, dentistry, cardiology and genetics, among the dozens of participating senior attending physicians. The goals of the UDP include providing answers to patients with mysterious conditions that have long eluded diagnosis and to advance medical knowledge about rare and common diseases. The UDP was established to evaluate participants who have undiagnosed medical conditions. UDP participants have generally received extensive diagnostic workups before traveling to NIH and often have numerous and/or complex medical problems. The UDP program makes use of a diverse set of diagnostic and research techniques both to attempt to find a diagnosis and to generate research projects to advance medical knowledge. The NHGRI-Division of Intramural Research (DIR)-Undiagnosed Diseases Program (UDP) protocol 76-HG-0238, Clinical Trial Number: NCT00369421 is connected to this clinical testing, which began in 2008 as a vehicle for admitting patients with a broader range of inborn errors of metabolism. Under this observational protocol study, the researchers in the study intend on diagnosing and treating certain inborn errors of metabolism. By doing this, researchers hope to expand their knowledge about these disorders and provide access to patients of interest for research, teaching, and clinical experience. Patients enrolled in this protocol have been referred with a known or suspected inborn error of metabolism, heritable disorder, or genetic predisposition. PERIOD OF PERFORMANCE : The proposed period of performance, for this requirement, is June 20, 2013 through September 30, 2013. PROJECT DESCRIPTION : The objective of this acquisition is to provide cutting edge cellular glycomics analysis of cultured fibroblasts from individuals who have had abnormalities identified by glycan analysis. Procurement : Consumables for 50 patient fibroblast lines Units PNGaseF 15 sep-Pak C18 (10 unit) 30 desalt cartridge (10 unit) 30 isomathane 10 C13 labelled isomathane 5 Dowex 50x-8 (H+) 15 MALDI plate (1 unit) 10 Centrifuge tube 5 CONTRACTOR REQUIREMENTS : A. Specific Tasks: 1. The Contractor shall provide cutting edge glycomics analysis of cultured fibroblasts for congenital disorders of glycosylation (CDG). N-linked, O-linked or free glycans will be isolated and purified from cultured skin fibroblast of UDP patients and the glycomics profiles of patients will be compared with glycomics of fibroblast from control normal people, both qualitatively and quantitatively by isotope labeling method and MALDI-TOF/TOF or LC-MS/MS method. 2. The Contractor shall provide test results in a format that can be integrated with exome sequence variant analysis and support the ongoing collaborative research expertise needed by the NHGRI, UDP. 3. The Contractor shall provide unique services specific to complex CDGs to meet the program goals of the UDP. 4. The Contractor's turn-around-time for UDP to receive results will be 6 weeks once the initial validation is completed. 5. The Government will be contacted if any patient results need to be evaluated urgently for impact on caring for patients in the UDP. 6. The Contractor shall supply electronic copies of all reports appropriate for deposition in the UDP process management system and for exome sequence variant analysis. B. Desired Results/Functions/End Items: 1. The Contractor shall provide test results with qualified interpretations in a timely way given the requirements of the particular test the UDP Clinicians request. 2. The Contractor's research collaborations will be conducted via video conferences, email communications, shared professional presentations, posters and publications. Grand Round presentations at the Contractor's location and the NIH Clinical Center may also occur. C. Technical Specifications/Standards/Methods: The Contractor shall supply results with qualified interpretations in formats appropriate to the exome analysis pipeline and process management systems. D. Special Handling or Handling Requirements: The Contractor shall provide result reports and record methods and materials as appropriate to the highest scientific standards. These materials, methods, and results will be shared with agreed upon UDP collaborators. E. Reporting Requirements and Deliverables: 1. The Government will receive all electronic results within 6 weeks of the Contractor receiving the samples once the initial validation study (3M) is completed. 2. The Government will receive additional reports for any test added-on after the Contractor receives the original specimen. 3. The Government will receive additional reports for any parental or sibling testing done for the clarification of a new genetic disease. JUSTIFICATION The Emory University School of Medicine, Department of Human Genetics (hereinafter referred to as "the Contractor") laboratory provides a wide-range of tests, with family follow-up as needed, as well as supports the ongoing, collaborative research expertise required by the National Human Genome Research Institute (NHGRI), Undiagnosed Diseases Program (UDP). The Contractor offers unique services specific to congenital disorders of glycosylation that meet the mission oriented goals of the Undiagnosed Diseases Program; provides rapid turn-around-time (TOT), which in most cases is 4 weeks; and informs NHGRI program staff of any pertinent information that needs to be passed on urgently that would adversely impact the care of patients in the Undiagnosed Diseases Program. The Contractor is uniquely qualified and possesses the knowledge, historical background, and expertise to perform the requirements of this contract. Emory University School of Medicine, Department of Human Genetics was established by Emory University in 1970, as the only comprehensive provider of clinical and laboratory genetic services in Georgia. Emory University School of Medicine, Department of Human Genetics laboratory provides highly specialized testing for congenital disorders of glycosylation. In addition, the Contractor has conducted research in the specialized field of enzymology and biological testing for congenital disorders of glycosylation for over a decade. As a result, the Contractor has several peer-reviewed publications that are indicative of uniquely qualified expertise in the field of mitochondrial beta oxidation and protein glycosylation. This requirement involves the NHGRI-Division of Intramural Research (DIR)-Undiagnosed Diseases Program (UDP) protocol 76-HG-0238, Clinical Trial Number: NCT00369421, which is connected to this testing and requires continued collaboration with Emory University School of Medicine, Department of Human Genetics for their unique expertise in laboratory genetic services. REGULATORY AUTHORITY This acquisition is conducted under the authority of 41 U.S.C. 253(c), as set forth in FAR Part 13.106-1(b)(1), Soliciting from a single source, not exceeding the simplified acquisition threshold, and is exempt from the requirements of FAR Part 6, Competition Requirements. ADDITIONAL INFORMATION The intended procurement will be classified under North American Industry Classification System (NAICS) Code 541712, Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology), and the corresponding Small Business Size Standard is 500 employees. The resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-66 (April 1, 2013). This notice of intent is not a request for competitive proposals. Interested parties may identify their interest and capabilities in response to this synopsis by June 11, 2013, 3:00 p.m. Eastern Standard Time. The determination by the Government not to compete the proposed purchase order based upon responses to this notice is solely within the discretion of the Government. Any information received as a result of this pre-solicitation / notice of intent will be considered solely for the purpose of determining whether to conduct any future competitive procurements. Responses to this notice shall contain sufficient documentation to establish the interested parties' bona-fide capabilities for fulfilling the requirement. Inquiries to this announcement, referencing synopsis number NHLBI-CSB(HG)-2013-173-MKL, may be submitted to the National Heart, Lung, and Blood Institute, Office of Acquisitions, COAC Services Branch, 6701 Rockledge Drive, Room 6146, Bethesda, Maryland 20892-7902, Attention: Ms. Melissa K. Lombardo. Responses may be submitted electronically to lombardm@nhlbi.nih.gov. Faxes will not be accepted. Responses will only be accepted if dated and signed by an authorized company representative.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-CSB(HG)-2013-173-MKL/listing.html)
- Place of Performance
- Address: National Institutes of Health, 9 Memorial Drive, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03082373-W 20130608/130607000820-25a8c0507f6bdf5df1ce0f0806e57fa8 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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