SOLICITATION NOTICE
A -- Recipient Epidemiology and Donor Evaluation Study III (REDS-III) – Brazil International Site
- Notice Date
- 6/28/2017
- 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
- HHSN268201100007I-NOI
- Archive Date
- 7/28/2017
- Point of Contact
- Kelli Malkin,
- E-Mail Address
-
Kelli.Malkin@nih.gov
(Kelli.Malkin@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 MODIFICATION WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA) intends to negotiate and award a contract modification without providing for full and open competition (Including brand-name) to Blood Systems, Inc. for the Recipient Epidemiology and Donor Evaluation Study III (REDS-III) - Brazil International Site. THIS IS A SYNOPSIS. THIS IS NOT A SOLICITATION. BACKGROUND The incumbent Contract No. HHSN268201100007I is for the Brazil International Site of the Recipient Epidemiology and Donor Evaluation Study III (REDS-III) program. The objective of REDS-III is to assure safe and effective blood banking and transfusion medicine practices through a comprehensive, multi-targeted strategy involving basic, translational, and clinical research to improve the benefits of transfusion while reducing its risks. Improving blood component safety and availability in the U.S. and internationally through the conduct of epidemiologic, survey, and laboratory studies is the cornerstone of the REDS program. Transfusion therapy is the most commonly employed, and, arguably, one of the least understood medical procedures in the U.S., affecting about five million recipients annually. This research program is not only critical to public health in the U.S., but also to countries struggling with the HIV epidemic where blood safety and availability are major concerns. The REDS-III program is comprised of one Central Laboratory, one Data Coordinating Center, four Domestic Hubs, and three International collaborative sites in Brazil, China, and South Africa. PURPOSE, CONTRACT STRUCTURE, AND PERIOD OF PERFORMANCE The proposed action is a modification to an existing single award Indefinite Delivery, Indefinite Quantity (IDIQ) contract, with cost-reimbursement task orders. The contract modification will increase the maximum ordering value of the IDIQ contract. This modification will not obligate any funds; funds are obligated under task orders that are issued against the base IDIQ contract. REDS-III contractors are currently completing Phase 2 of the contract, conducting several study protocols and compiling donor, recipient, and linked databases, and performing laboratory testing. This modification is necessary to award Phase 3 of the contract. PROJECT REQUIREMENTS In Phase 3, the Brazil Site is expected to provide the necessary technical expertise and facilities to effectively perform the tasks and meet the requirements identified below: 1. The U.S. blood center shall manage the REDS-III international site's scope of work and study protocols and ensure transmission of complete and accurate scientific data from the foreign blood collection sites (subcontracts) to the REDS-III DCC, in accordance with procedures set forth in the protocols and Manuals of Procedures. 2. The U.S. blood center shall manage, through foreign subcontracts, the collection of a minimum of 250,000 blood donations annually from at least three collaborating and geographically dispersed foreign collection sites located in a low or middle income country affected by the AIDS epidemic. Each foreign blood collection site must collect a minimum of 25,000 donations annually. 3. The U.S. blood center Principal Investigator shall serve as a member of the REDS-III International Advisory Committee. As a member of the International Advisory Committee, actively participate in the review and approval of the REDS-III International study portfolios as well as evaluate international program progress to ensure that the overall objectives of the REDS-III program are being met. 4. The U.S. blood center and foreign investigators shall serve as members of the REDS-III country-specific International Steering Committee. As members of the country-specific International Steering Committee (and its subcommittees, as appropriate), serve as active participants in developing, reviewing, finalizing and prioritizing proposed country-specific epidemiology, survey, and laboratory studies; participate in the development of study forms, questionnaires, and Manual of Procedures by providing technical expertise in the areas of blood safety and availability and with specific issues pertaining to the conduct of blood safety and availability studies in the participating foreign country; oversee and ensure the progress of ongoing studies; develop, review and approve analyses, presentations, and publications; and report to the REDS-III International Advisory Committee and Executive Committee on research activities including progress of international study protocols. The final protocols must be approved by the REDS-III country-specific International Steering Committee and Executive Committee before being approved in writing by the NHLBI Contracting Officer. 5. The U.S. blood center and foreign collection sites shall participate in, coordinate, and successfully conduct the REDS-III research protocols that have been approved by the REDS-III country-specific International Steering Committee. Performance shall be in accordance with study protocols. Provide strong, proactive leadership in coordinating efforts to ensure the successful conduct of all research protocols. Obtain all necessary administrative and regulatory clearances. Incorporate study protocols into foreign blood centers' operations as needed. Contact and enroll participants in study protocols, conduct blood record review, and conduct follow-up visits as required per study protocols. Collect and transmit all data to the DCC as required by each protocol. Collect, process, and ship biospecimens according to protocol specifications. Field all inquiries related to REDS-III research studies. Data shall be analyzed centrally by the REDS-III DCC, unless otherwise specified by the NHLBI COR. 6. The U.S. blood center shall oversee the management of a Centralized Data Collection Center (CCC). The CCC shall be responsible for collecting all REDS-III country-specific data, transmitting the data to the DCC, and providing the necessary IT and data management expertise. In phase 3, the CCC shall maintain previously collected data files/datasets (transmitted to the DCC in phase 1 or 2) and, if necessary, have the potential capacity to obtain and transmit any additional data to the DCC deemed necessary to finalize an NHLBI-approved analysis or study, as directed by the COR. If appropriate, provide data to the REDS-III DCC in an electronic format, as specified by the DCC, in a timely manner for compilation into databases and data sets. English versions of code books must accompany databases and data sets being provided to the DCC. This information shall be a deliverable to the DCC at specified intervals. Maintain procedures to maintain data security and confidentiality. 7. The U.S. blood center shall be responsible for translating all materials. Translate study materials (protocols including informed consents, questionnaires, and forms) and Manuals of Operations prepared in collaboration with the DCC to appropriate languages or dialects, or to English, as appropriate. Final protocols and Manuals of Operations must be approved in writing by the NHLBI REDS-III Contracting Officer's Technical Representative(s). 8. The U.S. blood center shall oversee the collection, processing, testing, and storage of biospecimens by the foreign blood collection sites as required by study protocols. Samples shall be cataloged, tested, and stored according to protocols. The international sites shall be responsible for the conduct of all laboratory testing not being conducted in the U.S. which should represent the vast majority of required testing. Collection of specimens as part of laboratory-based research studies or epidemiologic investigations is permitted and can be established at the foreign blood centers or at a central location. However, large, labor-intensive repositories or population-based repositories (usually > 100,000 biospecimens) are not within the current scope of this program. Strict confidentiality of biospecimens, test results and related data shall be maintained by all REDS-III participants. 9. In collaboration with the REDS-III central laboratory and the DCC, the U.S. blood center shall oversee the shipment of specific biospecimens of research interest to the U.S. for laboratory testing which for technical or financial reasons is better accomplished at the central laboratory (or at another US testing facility subcontracted by the central laboratory). 10. Develop new REDS-III Data Analysis requests in collaboration with the REDS-III DCC as directed by the COR, and disseminate REDS-III research results by preparing scientific reports for publication and presentation. REDS-III data shall be analyzed centrally by the REDS-III DCC, unless otherwise specified by the NHLBI COR. As directed by the COR, develop data analysis requests in collaboration with the DCC that use REDS-III data that were collected for specific in country REDS-III studies or in the large REDS-III in-country cumulative donor and donation databases. If approved by the NHLBI COR, the contractor can conduct analyses of specific study data. In which case, the contractor shall provide the necessary statistical and analytical capabilities as well as the necessary statistical programming expertise, as reviewed and approved by the NHLBI COR. All data analysis requests (whether the analysis is led by the DCC or by the contractor) will be subject to review by the REDS-III in-country Steering Committee members and the REDS-III Executive Committee, and shall be approved by the CO and COR before being implemented. All analyses results conducted by the contractor will be subject to review by the REDS-III in-country Steering Committee members, the REDS-III Executive Committee, and the REDS-III Publication Committee. The contractor will disseminate REDS-III data results through publications and presentations. Abstracts, presentations, press releases, reports or manuscripts for publications resulting from any REDS-III data analyses (whether the analysis is led by the DCC or by the contractor) shall adhere to the REDS-III publication policy. 11. Participate in all committee and subcommittee meetings, conference calls, and organizational training sessions of which the international site Investigators and staff are members. 12. The U.S. blood center and foreign blood collection sites shall obtain all necessary governmental, administrative and regulatory approvals to ensure participation in and successful completion of all studies included in the REDS-III country-specific research portfolio. The U.S. blood center and foreign blood collection sites shall obtain all governmental, administrative and regulatory approvals necessary to 1) conduct the research program in the foreign country; 2) provide to the REDS-III DCC data from all blood collections, epidemiologic studies, laboratory studies, and surveys conducted under the contract; 3) provide any required selected biospecimens to the REDS-III central laboratory and potentially the NHLBI Biological Specimen Repository in the U.S; and 4) perform any activities related to closure of datasets and studies. 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 party's bona-fide capabilities for fulfilling the requirement, addressing each project requirement separately. The response should also include: 1) the professional qualifications of scientists, medical experts, and technical personnel as it relates to the above outlined requirements; 2) a description of general and specific facilities and equipment available, including the software used analyze study data; 3) an outline of previous research projects that are similar to the project requirements in which the organization and proposed personnel have participated; 4) any other information considered relevant to this program; and 5) 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 modification 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 the closing date on this notice and must reference the solicitation number. Responses may be submitted electronically to Kelli Malkin at kelli.malkin@nih.gov.
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