SOLICITATION NOTICE
B -- Translation and Research Data Collection Services
- Notice Date
- 3/20/2014
- Notice Type
- Presolicitation
- NAICS
- 541711
— Research and Development in 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
- HHS-NIH-NHLBI-CSB-(HG)-2014-089-DLM
- Archive Date
- 4/11/2014
- 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 CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). This is a follow-on requirement : The National Heart, Lung, and Blood Institute (NHLBI) Office of Acquisition (OA) the National Human Genome Research Institute (NHGRI), intends to negotiate and award a purchase order on a noncompetitive sole source basis to Khaled Hejazi to provide translation services and continue to conduct data collection of biological specimens from families with a history of oral clefts in Damascus Syria. PROCUREMENT : 1. Translation Services, Number of Hours: 1000; and 2. Patient ascertainment, patient and family enrollment, follow-up of existing study participants. BACKGROUND : 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. NHGRI supports the development of resources and technology that will accelerate genome research and its application to human health. A critical part of the NHGRI mission continues to be the study of the ethical, legal and social implications (ELSI) of genome research. NHGRI also supports the training of investigators and the dissemination of genome information to the public and to health professionals. The National Human Genome Research Institute (NHGRI), Division of Intramural Research (DIR), overall mission is to develop and implement technology for the rapid isolation, analysis, and treatment of genetic diseases. The Division's research laboratories and clinical branches develop and use the most advanced techniques to study the fundamental mechanisms of inherited and acquired genetic disorders. Research also includes planning and conducting clinical trials to test DNA-based methods for treatment and perhaps the cure of such diseases. Researchers collect and study families in which important diseases are inherited as well as, translate basic science advances into effective, reliable, and cost effective DNA and cytogenetic-based diagnostics. As part of a continued collaborative effort under revised protocol OH97-HG-N035, last approved by the NHGRI Institutional Review Board on May 23, 2013, individuals from multiplex families determined to have hereditary oral clefts will continue to be studied. Data will be collected the IBN Al-Nafees Hospital in Damascus, Syria as well as biological specimens from individuals who are members of families determined to have multiple family members affected with hereditary oral clefts. Translation services will continue to be provided for this study. The data collection has been very successful in the past but additional families are needed to increase the power of the study and to ensure detection of all important genetic effects and the Contractor will recontact members of previously enrolled families as needed by the NIH investigators. OBJECTIVES : The purpose of this procurement is to provide professional services to the NIH researchers dedicated to the study. Since the beginning of this study in April 1998, it has been determined by the principal investigator, that two tasks are required for the successful conduct of this study of hereditary oral clefts in the Syrian Arab Republic. The objective of the study is to identify the gene(s) involved in heritable oral clefts by linkage analysis and gene mapping strategies. Characterization of genes involved in causing inherited oral clefts could provide important insight into the inheritance and pathogenesis of this disease. The families available for study in the Syrian Arab Republic are unique in that the family size is large, the generation time is short, and there are many families with multiple individuals affected with non-syndromic oral clefts. Such families are extremely rare in the United States and the families enrolled in this study allow NIH researchers to perform powerful studies that may help to identify genetic risk factors for oral clefts that will then be applicable to individuals in the U.S. Task 1: Data Collection Services : • The Contractor shall provide: determination of eligibility, patient registration, clinical evaluation of family members, biological sample collection and shipment, recontact of previously studied family members as needed by the NIH scientists to update information or consents and to explain clinically relevant results if needed. Task 2: Translation and Various Tasks : • The Contractor shall perform translation in the following areas: word processing, informed consent forms, protocol documentation and amendment, study newsletter, conference calls, study and contract administrative documents, email and written communications with Syrian clinicians, etc. The NIH does not offer translation in Arabic for this wide array of services. C. CONTRACTOR REQUIREMENTS : • Task 1: The contractor will engage in several activities, including: (1) determination of eligibility, (2) patient registration, (3) clinical evaluation of family members, (4) biological sample collection and shipment, and (5) recontact of previously studied family members as needed by the NIH scientists for updating information, obtaining additional informed consent, obtaining additional biological samples and communicating results to families when approved by both the NIH and Syrian ethics oversight committees. • Task 2: The contractor will engage in several translation activities (some of which require the ability to utilize a word processing/software package such as WordPerfect for Arabic): (1) Translation of all study documents into Arabic. Any new changes to the study protocol, clinical questionnaires or consent forms required by the NHGRI IRB will be translated as well as any other documents required by the NIH; (2) Translation services for phone calls and emails between the Contractor and the Principal Investigator; and (3) Translation services to clarify questions and problems between the Principal Investigator and the site investigators, (4) Translate other documents for the study such as letters to Syrian officials when deemed necessary, the study newsletter for participants, study and contract administrative documents and other documents as needed, and (5) Perform other translation services as needed. D. REPORTING REQUIREMENTS AND DELIVERABLES : • The contractor shall work with the research team and other members of the NHGRI on an as needed basis. They will communicate progress and provide summary of activities, either orally and in writing, to the NIH Principal Investigator. • Reports may be brief summary of emails. In addition to these progress reports, the contractor shall: (1) translate any documents as needed and provide translation services when communication is needed between the Principal Investigators and other investigators involved in the research study; (2) deliver the pedigree data and biological specimens as collection of each family is completed, and (3) recontact previously enrolled families as needed by the NIH investigators. • The contractors shall meet the principal investigator at a scientific meeting or participate in teleconferences as needed for planning and development of the data collection efforts. E. PROGRAM MANAGEMENT AND CONTROL REQUIREMENTS : • The contractor shall work independently with no direct supervision by any government employee. The study Principal Investigator and other research team members will provide guidance in terms of technical reporting needs and study requirements of the project supported. G. GOVERNMENT RESPONSIBILITIES : • The contractor shall provide his own supplies, computer equipment, and space to work. On occasions when collaborative efforts will occur, the contractor will have temporary use of government space and computer equipment on an as-needed basis. H. INSPECTION AND ACCEPTANCE CRITERIA: • The contractor shall provide draft documentation, reports, and progress of the work and will produce translated versions of all documents in both English and Arabic. The Government's Principal Investigator will review, inspect, and approve all documentation to ensure that work is in line and following the objectives of the study. Period of Performance : 12 Months from the date of Award 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, only one responsible source and no other supplies or services will satisfy agency requirements. Industry Classification (NAICS) Code is 541711, Research and Development in Biotechnology and the small business size standard in number of employees 500. 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) 05-72 (January 30, 2014). 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 by March 27, 2014, 7:30 a.m. Eastern Time and must reference synopsis number HHS-NIH- NHLBI-CSB-(HG)-2014-089-DLM, may be submitted to the National, Heart, Lung and Blood Institute, Office of Acquisition, COAC Services Branch, 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."
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- Place of Performance
- Address: Contractor and NIH Location, United States
- Record
- SN03316489-W 20140322/140320235551-4bce06e0defead864c9c660c759e027f (fbodaily.com)
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