SOLICITATION NOTICE
B -- Review Board Coordinator
- Notice Date
- 8/31/2006
- Notice Type
- Solicitation Notice
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Office of Administration, 6011 Executive Blvd, Rm 538, Rockville, MD, 20892-7663
- ZIP Code
- 20892-7663
- Solicitation Number
- 263-2006-Q-DT-0216
- Response Due
- 9/11/2006
- Archive Date
- 9/26/2006
- Description
- The National Institutes of Health (NIH) intends to negotiate on a sole source basis with Emory University Admin Bldg. Atlanta, GA, 30322, in general and Mr. Faucett in paticular for a continuation of the services being provided for The Office of Rare Diseases. Emory University/Mr. Faucett is the only known source capable of providing the required services because of his involvement in this project over the past months. Further, inherent duplication of cost to the Government would be time and cost prohibiting.1. The contractor shall work with the Collaboration, Education and Test Translation Program (CETT) Review Board, the Review Board Coordinator (RBC), Review Board Consultants, Program Scientific Advisor, the Office of Rare Diseases (ORD), the CETT Program Collaborative Advocates, advocacy groups, researchers, and CLIA- certified clinical laboratories in the continued development, implementation, and evaluation of the CETT Program. 2. The contractor shall have at least fourteen (14) years of experience in direct patient care and current occasional patient consultations in the use of genetic testing and genetic services. 3. The contractor shall assist the CETT Review Board in providing an expert opinion to the funding agency or agencies. The contractor shall also provide expert opinion to any other party who sponsors diagnostic genetic test translation within the rare disease community, in the CETT processing of clinical genetic test translation of rare diseases from the research setting into clinically available testing in CLIA laboratories. 4. The contractor shall assist the Review Board, who will be responsible for providing guidance to the RBC in the continued development of the application process for any collaborative group interested in the translation of tests for rare genetic diseases from the research setting to CLIA-certified clinical laboratories. 5. The contractor shall, with input from the scientific advisor, provide a preliminary review which shall be designed to ensure that the necessary elements are in place before the applicants invest in the completion of educational materials and data collection tools. 6. The contractor shall, along with the CETT Program Scientific Advisor, determine when a proposal is complete and ready to be submitted to the RBC. 7. The contractor shall facilitate the translation of diagnostic tests for rare genetic diseases from the research setting to CLIA-certified clinical laboratories. 8. The contractor shall provide advice and support to a Project Officer in ORD. 9. The contractor shall work with the Review Board Coordinator, Review Board Consultants, Program Scientific Advisor, ORD, and other sponsoring agencies to refine the process and application forms. 10. The contractor shall work with the advocate members of the CETT Program Review Board, volunteer national patient advocate leaders, and experienced genetic counsellors to refine the CETT Program Collaborative Advocates support network for CETT applicant groups. 11. The contractor shall work with the CETT Program Advocates and others to develop examples of test educational materials for patients and clinicians. The contractor shall also provide links to examples of quality educational materials previously developed for other clinical tests. 12. The contractor shall obtain input from the American College of Medical Genetics (ACMG), the American Society of Human Genetics (ASHG), the Association of Molecular Pathologists (AMP), the Genetic Alliance, the National Organization for Rare Diseases (NORD) and other groups interested in rare genetic disease testing. 13. The contractor shall on a continuous basis, evaluate and refine materials describing the CETT application and review process to be posted on the program web site and linked with other websites. 14. The contractor shall maintain a web based application system for new tests and collect applications. 15. The contractor shall monitor/review GeneTests, clinicians, and advocacy groups to gather continuous data on the number of rare diseases that would benefit from test development through the CETT process. 16. The contractor shall work with interested groups to develop collaborations to meet the process requirements and facilitate the application process. 17. The contractor shall identify and provide resources for educational material development and editing assistance. 18. The contractor shall promote the CETT process widely among those interested in rare genetic disease testing and highlight successful translations through meetings, list-serves, etc. This includes, but shall not be limited to the following: a. National Laboratory Network (NLN), other networks, and academic and industry laboratories. b. Federal agencies involved in genetic research, laboratory testing, and clinical genetic services. c. The American College of Medical Genetics (ACMG), the American Society of Human Genetics (ASHG), the Association of Molecular Pathologists (AMP), the Genetic Alliance, and the National Organization for Rare Disease (NORD). d. Medical specialities other than medical genetics (e.g., cardiology, endocrinology, otolaryngology). e. National and international groups that might want to consider the CETT Program as an example of how tests might be successfully moved from the research arena to the clinical testing arena. 19. The contractor shall maintain a log of all inquiries and the status of all tests requested or considered for translation. 20. The contractor shall monitor the application process to identify barriers to the process and consider process changes to remove identified barriers. 21. The contractor shall periodically update and document progress of CETT and community needs of the program. 22. The contractor shall periodically ascertain from all groups participating in the process and receive suggestions for revisions. 23. The contractor shall participate in bi- weekly conference calls, and periodic meetings with the Program Scientific Advisor, Review Board Coordinator, Review Board, consultants and ORD to review CETT program and progress. 24. The contractor shall submit quarterly reports, except in the quarter that an annual report is due. 25. The contractor shall submit annual reports. 26. The period of performance shall be from September 1, 2006 through August 31, 2007. This proposed action is for services for which the Government intends to solicit and negotiate with only one source. Interested parties may identify their interest and capability to respond to the requirement or submit proposals. This notice of intent is not a request for competitive quotations. However, all quotes received within ten days after the date of publication of this synopsis will be considered by the Government . A determination by the Government not to compete this proposed simplified acquisition requirement based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive acquisition. Concerns that respond to this synopsis shall furnish concise responses directed specifically to the requirements mentioned above and are invited to submit proposal and/or capability statements in an Original Plus Two (2) no later than ten (10) business days from the date of this announcement, August 31, 2006, due in COB Sept. 11, 2006. Written responses shall include complete description of services to be provided, containing sufficient technical information to permit agency analysis to establish bona fide capability to meet the stated requirements as listed above. Proposals And/Or Capabilty Statements Shall BE Sent To: (a) If mailing your capabilities through the U.S. Postal Service use the following address: National Institutes of Health, Office of Logistics and Acquisition Operations, OA, 6011 Executive Blvd. Rm. 529V, ATTN: Lloyd Garnes, Bethesda, MD 20892, telephone: 301-402-3341; fax: 301-480-3476. (b) If hand delivering, or using a courier service such as: UPS, FeDex, etc., use the following City, State and Zip Code: Rockville, MD 20852. Respondents will not be notified of the evaluation results. (c) Questions may be emailed to Lloyd Garnes at garnesl@od.nih.gov no later than Sept. 05, 2006.
- Place of Performance
- Address: Bethesda, MD
- Zip Code: 20892
- Country: UNITED STATES
- Zip Code: 20892
- Record
- SN01131100-W 20060902/060831220435 (fbodaily.com)
- Source
-
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