SOLICITATION NOTICE
B -- Upper Gastrointestinal (UGI) Cancer Prevention Studies
- Notice Date
- 4/4/2017
- Notice Type
- Presolicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- N02CP71013-58
- Point of Contact
- Gary G. Debes, Phone: 2402767605, Rosa M. Lopez, Phone: 2402765426
- E-Mail Address
-
gary.debes@nih.gov, rosa.lopez@nih.gov
(gary.debes@nih.gov, rosa.lopez@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Synopsis: THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION DOCUMENT WILL BE ISSUED ON A LATER DATE. The Division of Cancer Epidemiology and Genetics (DCEG) of the National Cancer Institute (NCI) intends to negotiate with the Cancer Hospital Chinese Academy of Medical Sciences (CHCAMS) for a 1-year contract with four 1-year options. The purpose of this contract is to: (1) continue maintaining an existing biorepository, upgrading freezers in the biorepository, monitoring the temperature of the freezers in the biorepository, maintaining appropriate alarm systems and backup generators for the repository, and maintaining access to an emergency supply of liquid nitrogen in the event of electrical failure; (2) continue the follow-up of Nutrition Intervention Trials (NIT) participants and all prior Early Detection of Esophageal Cancer (EDEC) project participants for vital status and cancer endpoints, including monthly surveillance via local doctor records and quarterly checks of the Linxian Cancer Registry, collection of all available diagnostic materials for subjects who develop cancer, and review of diagnostic materials; (3) transfer of biospecimens as required; (4) consult with Division of Cancer Epidemiology and Genetics (DCEG)/NCI investigators as required; and (5) prepare reports as needed in support of activities associated with this contract. The efforts from this contract will permit continued study of trial participants previously enrolled in Linxian intervention and early detection studies for vital status and cancer endpoints, and maintain, upgrade, and utilize existing biorepository specimens for etiologic and early detection investigations. The Nutritional Intervention Trials are two double-blind, placebo-controlled randomized intervention studies conducted in Linxian, China to evaluate multiple vitamins/minerals in the prevention of esophageal and other cancers. Beginning in 1985, the Dysplasia Trial evaluated 3318 persons with cytologic evidence of dysplasia supplemented for 6 years, while the General Population Trial evaluated 29,584 persons supplemented for 5¼ years. Biologic specimens were collected periodically throughout the trials and are stored at CHCAMS. Post-intervention follow-up has continued since 1991. Because the NITs were conducted in China by CHCAMS and the blood samples are in China at CHCAMS, the continued follow-up proposed here must be conducted in China by CHCAMS. Similarly, the EDEC Project was also conducted by CHCAMS in the Linxian region and has cumulatively enrolled over 4000 subjects in several different studies conducted as part of this project. The proposed contract action is for services for which the Government intends to solicit and negotiate with only one source under authority of FAR 6.302. Statutory authority: 41 U.S.C. 3304 (a)(1), as set forth in FAR 6.302-1(a)(2)(ii), only one responsible source and no other supplies or services will satisfy agency requirements. CHCAMS is the only responsible source and no other supplies or services will satisfy agency requirements. The contractor is uniquely qualified for the following reasons: 1. The contractor has invested substantial time and resources in obtaining the necessary IRB approvals for this study from the Chinese government. IRB approvals in China are considered a form of binding agreement between the subjects enrolled and the contractor. Thus, all data obtained (including the identifying information necessary to perform the follow-up) is held confidentially by the contractor and is not transferable to any other entity. 2. The NIT and EDEC studies were initially developed by CHCAMS and therefore the Chinese government has designated CHCAMS to be the official institution devoted to these studies. This was the basis for the initial and subsequent sole sourced contracts. As such, CHCAMS is the only institution who has access to the NIT and EDEC study population and the data collected on the NIT and EDEC cohorts. Only through an active collaboration with CHCAMS can NCI gain access to this valuable data and make productive use of it. No other such cohort exists and there is no other reasonable alternative to contracting directly with CHCAMS. 3. CHCAMS has developed working relationships with important entities, such as various regulatory boards, various hospitals and local governments in order to conduct the future studies proposed in this high-risk study population. 4. CHCAMS has already built trusting relationships over the past twenty-five or more (25+) years with the majority of participants who are enrolled in these studies. Continuity of study staff is viewed as an important component for success of follow-up of participants in past studies and recruitment of subjects to new studies. 5. CHCAMS has established the necessary infrastructure and resources to support the continued follow-up and has extensive expertise and experience for the project based on nearly 30 years of successful performance. The infrastructure includes a data base with all participants in previously-conducted intervention trials and early detection studies; clinical facilities for administration of questionnaires, conduct of clinical examinations including endoscopies, endoscopy equipment; laboratories for cytology, histology, and processing of venous blood samples; computers and computer support staff for data entry and data base maintenance; biospecimen repository capacity with temperature alarm and backup power system; and trained epidemiology and clinical staff to perform the various studies required. 6. A change of contract would invalidate the current approvals, invalidate the current consent with participants in the study, and would require re-contacting and re-consenting currently enrolled subjects for future follow-up. The proposed contract action is for supplies or services for which the Government intends to continue with one source under authority FAR 6.302. However, responsible sources may submit a capability statement, which shall be considered by the agency. Respondents should submit their capability statements via email to Gary Debes at gary.debes@nih.gov no later than 12:00PM Eastern on April 11, 2017. The RFP will be available electronically at a later date and may be accessed through FedBizOpps at www.fbo.gov. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile or email transmissions will be accepted. IT IS THE OFFEROR'S RESPONSIBILITY TO MONITOR THE ABOVE MENTIONED SITE FOR THE RELEASE OF THE SOLICITATION AND ANY AMENDMENTS. Place of Performance: Linxian, China
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- Record
- SN04459503-W 20170406/170404235541-032780c893b77621f4ecefd06e81c48f (fbodaily.com)
- Source
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