SOLICITATION NOTICE
B -- Cleft Palate Services/Arabic-English Translation for Cleft Palate and Research Data Collection Services
- Notice Date
- 5/18/2016
- 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
- HHS-NIH-NHLBI-CSB-(HG)-2016-135-DM
- Archive Date
- 6/8/2016
- 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 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) on behalf of the National Human Genome Research Institute (NHGRI), intends to negotiate and award a purchase order on a non-competitive sole source basis to Dr. Hasan Albacha-Hejazi to conduct data collection of biological specimens from families with a history of oral clefts in Damascus Syria and translation services. This is a Follow-On Requirement: Procurement : 1. Patient ascertainment, patient and family enrollment, follow-up of existing study participants, Number of Hours: 400; and 2. Translation Services, Number of Hours: 800. Period of Performance : Base Year: 12 Months: Patient ascertainment, patient and family enrollment, follow-up of existing study participants, Number of Hours: 400; and Translation Services, Number of Hours: 800. Option 1: 12 Months: Patient ascertainment, patient and family enrollment, follow-up of existing study participants, Number of Hours: 400; and Translation Services, Number of Hours: 800. 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. This initial Clinical Study has been undergoing since April 1998. 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 in 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. If possible, the Contractor shall collect biological specimens from unaffected Syrian individuals with no family history of 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 shall re-contact members of previously enrolled families as needed by the NIH investigators. Purpose and Objective : The purpose of this procurement is to provide professional services to the NIHresearchers 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. Dr. Hasan lbacha-Hejazi, will service as the head clinical investigator in the Syrian Arab Republic and this requirement. 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: The contractor will engage in several data collection activities, including: (1) determination of study participant 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 Dr. Hasan Albacha-Hejazi and Dr. Bailey-Wilson, (3) Translation services to clarify questions and problems between Dr. Bailey-Wilson 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. For Task 1: these services will be in the following areas: determination of eligibility, patient and control registration, clinical evaluation of family members, biological sample collection and shipment, re-contact of previously studied family members as needed by the NIH scientists to update information or consents and to explain clinically relevant results if needed. For Task 2: these services will be 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. Task 2 is closely interrelated to Task 1 and requires almost daily interaction with the Clinical Investigator and his research team. The Translator is part of the Clinical Research Team and has years of experience in work on this study. It would not be efficient for the U.S. Government to engage another translator who is not deeply embedded in the workings of this study and who has the trust of the Clinical Investigator. Use of a translating service not provided by the Clinical Investigator would result in significant extra effort for the Government personnel and therefore, significant extra costs to the Government and is therefore not justified. Additional Information : Because of Ethics and Human Subjects Review Board requirements, NIH investigators do not hold personally identifying information on these study participants. Only the Clinical Investigator and his research team in Syria at the IBN AL NAFEES hospital are authorized to have this information and to recontact previously enrolled study participants. In addition, no business entity outside of the Syrian Arab Republic has hospital privileges at Syrian hospitals and no other entity has current Ethics Board (Human Subjects Protection) approval with the exception of Clinical Investigator Dr. Hassan Albacha Hejazi. Contractor's Requirements : Task 1: The contractor shall engage in several activities, including: (1) determination of eligibility for patients and controls, (2) patient and control registration, (3) clinical evaluation of family members, (4) biological sample collection and shipment, and (5) recontact and update the status 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 shall 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, (3) Translation services to clarify questions and problems between 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. Reporting Requirement 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 quarterly. These reports may be brief summary 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 Investigator and the Contractor or other investigators, 2) deliver the pedigree data and biological specimens as collection of each family is completed, and 3) re-contact previously enrolled families as needed by the NIH investigators. The contractors will meet the principal investigator at a scientific meeting or participate in teleconferences as needed for planning and development of the data collection efforts. 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. Government Responsibilities : The contractor shall provide his own supplies, computer equipment, and space to work. On occasions when collaborative efforts will occur, the contractor shall have temporary use of government space and computer equipment on an as-needed basis. Inspection and Acceptance : As plans are developed 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 Principal Investigator will review, inspect, and approve all documentation to ensure that work is in line and following the objectives of the study. Regulatory Authority : The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-88, May 16, 2016. This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart 13 Simplified Acquisition Procedures (SAP). Statutory Authority : This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 253(c)(1) as set forth in Federal Acquisition Regulation (FAR) 6.302-1(b)(1). Additional Information : 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). Industry Classification (NAICS) Code is 541712, Research and Development in the Physical Engineering and Life Sciences (except biotechnology) and the Small Business Size Standard is 500. 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. 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), May 24, 2016; and must reference synopsis number HHS-NIH-NHLBI-CSB-(HG)-2016-135-DM, 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, Contracting Officer. 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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FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-CSB-(HG)-2016-135-DM/listing.html)
- Place of Performance
- Address: Contractor's Location and NIH, United States
- Record
- SN04120742-W 20160520/160518234334-ca77bd1a2d4694204c2fbe09c5a60393 (fbodaily.com)
- Source
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