SOURCES SOUGHT
A -- Recipient Epidemiology and Donor Evaluation Study-IV-Pediatric (REDS-IV-P) – Data Coordinating Center (DCC)
- Notice Date
- 8/7/2017
- 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-SBSS-19HB00005R
- Point of Contact
- Kelli Malkin, , John Turner, Phone: 3014029787
- E-Mail Address
-
Kelli.Malkin@nih.gov, john.turner@nih.gov
(Kelli.Malkin@nih.gov, john.turner@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Introduction 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 NAICS code 541712 should not submit a response to this notice. The Division of Blood Diseases and Resources of the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), is seeking small businesses with the ability to perform as the Data Coordinating Center (DCC) for the program entitled "Recipient Epidemiology and Donor Evaluation Study-IV-Pediatric (REDS-IV-P)." It is anticipated that one award will be made around March 2019 for a period of seven years. Background The goal of the Recipient Epidemiology and Donor Evaluation Study-IV-Pediatric (REDS-IV-P) program is to evaluate and improve the safety and availability of the blood supply as well as the safety and effectiveness of transfusion therapies with attention to not only adults, but also neonates and children who need transfusion. This will be accomplished by the establishment of a seven-year multicenter program in the US and in Brazil, charged with conducting epidemiologic and laboratory studies in blood donors and transfusion recipients. This cohesive and comprehensive multicenter program will use a multi-targeted strategy to proactively address potential threats to the nation's blood supply; evaluate how to enhance the effectiveness and safety of transfusions; and serve as a resource for ongoing work in transfusion research. The REDS-IV-P program infrastructure will allow for evaluation of key research questions in transfusion medicine that are best studied through the analysis of a comprehensive set of epidemiological data on donors, donations, components, and transfused recipients as well as through the conduct of stand-alone multi-site laboratory and observational studies. Similar to its predecessor programs, REDS-IV-P will include a rapid research response capability to address emerging threats to the blood supply. The program will be poised to evaluate a new infectious agent quickly for its prevalence and incidence among blood donors, transfusion-transmission potential, risk factors, and clinical relevance to the blood recipient population and provide these data to inform the implementation of enhanced blood safety measures and policies. NHLBI plans to support one Data Coordinating Center (DCC), one Center for Transfusion Laboratory Studies (CTLS), up to four domestic hubs, and one international collaborative program in Brazil. THIS NOTICE ADDRESSES THE DATA COORDINATING CENTER ONLY. The REDS-IV-P Program is a 7-year program consisting of three phases: Phase 1 (Years 1-2): Development of study/project protocols, design of forms, REDS-IV-P Operating Procedures, Manuals of Operations for each study protocol and databases; review of data collection and research studies by oversight and regulatory boards; development and piloting of the donor, donation, component and patient databases; development of the resource sharing plan; conduct of Phase 1 database projects; and conduct of fast track research studies that can be developed and completed within Phase 1. Phase 2 (Years 3-5): Development of new study/project protocols, design of forms, and Manuals of Operations for study protocols; review of data collection and research projects by oversight and regulatory boards; conduct of Phase 2 study and database project protocols; cumulative compilation of all databases and datasets; laboratory testing; analysis of data; and dissemination of findings through presentations and publications. Phase 3 (Years 6-7): Conduct of study/project protocols; finishing transmission of all study data to the DCC; analysis of data; dissemination of findings through presentations and publications; closure of databases; and provision of all deliverables to NHLBI. The REDS-IV-P DCC shall be responsible for overall coordination, communications, data management, and analytical/statistical support for the multiple multi-center research studies and database projects anticipated to be conducted in parallel in the REDS-IV-P program domestically and internationally. Like its predecessors, REDS-IV-P is anticipated to be a comprehensive and complex program with the need for simultaneous and timely coordination of data management as well as sophisticated statistical analyses for multiple domestic and international clinical laboratory and observational research studies and projects. Project Requirements NHLBI is seeking a Data Coordinating Center (DCC) with experience in the development, coordination, data management and statistical analyses of large (defined as including >1,000 participants) multicenter epidemiologic (e.g., case-control, cohort), as well as complex survey(s) and clinical laboratory studies, and experience with the analysis of large numbers of repeated measures collected on participants followed longitudinally (as present in the linkable donor/donation, component, and patient databases). Experience in coordinating simultaneously multiple international as well as domestic large multicenter observational research studies is required. Other requirements are: • Experience in the collection of epidemiologic data from multiple sites, as well as experience in monitoring the quality and timeliness of data collected on a large number of individuals. • Experience in the area of blood banking and transfusion medicine. • Experience in conducting in parallel multiple analyses and monitor their timely progress, as well as in rapidly deploying experienced personnel to develop, coordinate, manage data, and analyze new research studies without affecting other ongoing REDS-IV-P projects and analyses. The DCC is expected to fulfill the following: 1. Coordinate REDS-IV-P activities and participate as a member of the Domestic and Brazil Steering Committees to develop and implement a coordinated plan to achieve program objectives. 2. Develop and maintain Operating Procedures for the REDS-IV-P program. 3. Establish and maintain a single IRB (sIRB) charged with conducting the ethical review required by the Department of Health and Human Services regulations for the Protection of Human Subjects for multi-center non-exempt human research conducted by the domestic REDS-IV-P program and manage and maintain all relevant records. 4. Develop and maintain a public and private REDS-IV-P website. 5. Develop, finalize, and maintain the protocols and associated Manuals of Operations for the cumulative centralized databases. 6. Coordinate and participate in the development and finalization of REDS-IV-P study protocols and develop corresponding Manuals of Operations. 7. Serve as a resource and collaborate with non-REDS-IV-P funded investigators as directed by the Contracting Officer's Representative (COR). 8. Collaborate as directed by the COR with existing research networks to conduct studies and/or database projects that address transfusion research questions of interest. 9. Provide all necessary data management and tracking systems. 10. Track all REDS-IV-P biospecimens and their associated data, and identify biospecimens for retrieval. 11. Provide training sessions and conduct site visits, as appropriate. 12. Provide biostatistical support during protocol development and analyze data collected during REDS-IV-P, unless otherwise directed by the COR. 13. Help develop database projects in collaboration with the Domestic Steering Committee and conduct ensuing statistical analyses. 14. Assist the Domestic and Brazil Steering Committees in preparation of scientific reports for publication and presentation. 15. Develop, coordinate, and implement a Resource Dissemination Plan. 16. Coordinate and convene the REDS-IV-P Maternal-Fetal, Neonatal, and Pediatric Committee. 17. Help coordinate and convene the REDS-IV-P NHLBI Observational Study Monitoring Board (OSMB). 18. Coordinate and convene the REDS-IV-P External Review Panel. 19. Interact with the NHLBI COR and Program Manager on programmatic research activity issues. 20. At close out of the study, or earlier as directed by the COR, create public use data sets for REDS-IV-P datasets (as directed by the COR) with documentation. 21. Ensure an orderly transition of REDS-IV-P resources to a successor contractor at contract expiration. Capability Statement Small business concerns that believe they possess the capabilities necessary to undertake this work should submit complete documentation of their capabilities to the Contracting Officer. Capability statements must provide evidence of ability to perform and demonstrated experience in performing the tasks described above. Capability statements will be reviewed based on the following: 1) evidence of the firm's status as a small business under NAICS code 541712 with a size standard of 500 employees; 2) accessible evidence of ability to coordinate and manage simultaneously multiple domestic and international multi-center, large epidemiologic, survey, and clinical laboratory research studies and fulfill the DCC functions described in tasks 1 through 21 above. This includes the ability to perform data management, biospecimen tracking and linking, statistical and analytical support, including assessing the reliability and validity of the data collected; preparation of public use data sets; and safeguarding federal information systems; 3) qualifications and availability of personnel with experience in the development, coordination, data management and statistical analysis of large (defined as including >1,000 participants) multicenter epidemiologic studies, as well as complex survey(s) and clinical laboratory studies in the area of blood banking and transfusion medicine; 4) accessible evidence of experience in the operation of a coordinating center for large multi-center international and domestic research programs; 5) adequacy of the organizational and administrative structure to participate in a multi-center international and domestic epidemiologic, laboratory and complex survey research program; 6) accessible evidence of experience in the collection of epidemiologic data from multiple sites, as well as experience in monitoring the quality and timeliness of data collected on a large number of individuals participating in epidemiologic studies, surveys, and clinical laboratory studies; and 7) availability of facilities, equipment, and resources necessary for the performance of the requirements identified above. The capability statement must not exceed 15 pages in length and using a 12-point font size minimum. Interested small business organizations are required to identify their size standards in accordance with the Small Business Administration. The Government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone numbers of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. Point of Contact: Kelli Malkin, Contracting Officer, Phone: (301) 827-7723, Email: Kelli.Malkin@nih.gov. John Turner, Contract Specialist, Phone: (301) 827-7735, Email: John.Turner@nih.gov. 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 RKL2/6114 MSC 7902, Bethesda, MD, 20892-7902, UNITED STATES Submission Instructions: Interested parties shall submit capability statements via the FedConnect web portal (www.fedconnect.net) and reference the FedConnect Sources Sought Number HHSN26819HB00005R. The due date for receipt of statements is 3:00 p.m. Eastern Time on August 22, 2017. Vendors can register with FedConnect at https://www.fedconnect.net/FedConnect/default.htm. Please note that FedConnect is used by multiple federal agencies and therefore FedConnect assistance will be provided by Compusearch Software Systems, not the NHLBI OA. More information about registration requirements can be found by downloading the FedConnect Ready, Set, Go! Guide at https://www.fedconnect.net/fedconnect/Marketing/Documents/FedConnect_Ready_Set_Go.pdf. For assistance in registering or for other FedConnect technical questions please call the FedConnect Help Desk at (800) 899-6665 or email at support@fedconnect.net. Please use the Contracting Officer/ Contract Specialist contact information provided, should you require a waiver not to use FedConnect for submitting. All responses must be received by the specified due date and time in order to be considered. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. No proprietary, classified, confidential, or sensitive information should be included in your 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 review of the responses received, pre-solicitation and solicitation notices may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-SBSS-19HB00005R/listing.html)
- Record
- SN04616267-W 20170809/170807232000-93034922855a33672dae07a863ef097b (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |