SOURCES SOUGHT
B -- Professional Services/Translation and Research Data Collection Services
- Notice Date
- 5/2/2016
- Notice Type
- Sources Sought
- 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)-SBSS-2016-127-DM
- Archive Date
- 5/25/2016
- 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
- This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice." Interested Parties capable of providing under the North American Industry Classification System (NAICS): 541712, Research and Development in the Physical Engineering and Life Sciences (except biotechnology) and the small business size standard in number of employees 500. The capability statement should be submitted electronically (via email) to Dorothy Maxwell, Contracting Officer, at maxwelld@mail.nih.gov, on May 10, 2016, 7:30 AM, Eastern Time (EST), Solicitation Number: HHS-NIH-NHLBI-CSB-SBSS-(HG)-2016-127-DM. 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. A. 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. B. Purpose and 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. 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: You must have authorized approval. 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. C. 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. D. 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. 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. F. 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. G. 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. H. Anticipated 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. I. Capability Statement /Information : Interested parties are expected to review this notice to familiarize itself with the requirements of this project. Failure to do so will be at your firm's own risk. The following information shall be included in the capability statement: 1. A general overview of the respondents' opinions about the difficulty and /or feasibility of the potential requirement, and any information regarding innovative ideas or concepts. 2. Information in sufficient details of the respondents' (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information. 3. The respondents' DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc.) pursuant to the North American Industry Classification System (NAICS) code: 541712, Research and Development in the Physical Engineering and Life Sciences (except biotechnology) and the small business size standard in number of employees 500. 4. Any other information that may be helpful in developing or finalizing the requirements of the potential acquisition. 5. The capability statement shall not exceed 10 single-sided pages (including all attachments, resumes, charts, etc.) presented in single-space and using a 12-point font size minimum, in either Microsoft Word or Adobe Portable Document Format (PDF), with 8-1/2 by 11 inch paper size, and 1 inch top, bottom, left and right margins. 6. All proprietary information should be marked as such. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern's name and address). Responses will be reviewed only by NIH personnel and will be held in a confidential manner. J. Closing Statement : The capability statement should be submitted electronically (via email) to Dorothy Maxwell, Contracting Officer, at maxwelld@mail.nih.gov, on May 10, 2016, 7:30 AM, Eastern Standard Time include Sources Sought Notice Number: HHS-NIH-NHLBI-CSB-(HG)-SBSS-2016-127-DM. All responses must be received by the specified due date and time in order to be considered. This Sources Sought Notice (SS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Heart, Lung, and Blood Institute (NHLBI). The NHLBI does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted. As a result of this notice, the NHLBI may issue a Request for Quote (RFQ). THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NHLBI shall arise as a result of a response to this notice or the NHLBI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. "Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s)."
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