SOURCES SOUGHT
R -- Support Services for Studies of Infection, Immunity, and Cancer - SOW
- Notice Date
- 2/19/2016
- Notice Type
- Sources Sought
- 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
- HHSN-NIH-NCI-SBSS-ETSB-71000-26
- Archive Date
- 3/22/2016
- Point of Contact
- Kathleen Y. Sears, Phone: 2402765435
- E-Mail Address
-
kathleen.sears@nih.gov
(kathleen.sears@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Draft Statement of Work SMALL BUSINESS SOURCES SOUGHT NOTICE Notice Number: HHS-NIH-NCI-SBSS-ETSB-71000-26 Title: Support Services for Studies of Infection, Immunity, and Cancer NAICS Code: The NAICS code for this acquisition is 541990. The small business size standard is $15M Type of Notice: This is a Small Businesses Sources Sought notice (SS). 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 business; HUB Zone small businesses; service-disabled, veteran-owned small businesses, 8(a) small businesses; veteran-owned small businesses; women-owned small businesses; or small disadvantaged business; 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. Background: The current support services contract (SSC) has supported study development and implementation activities, and provided data management and limited analytical support for multiple studies conducted by investigators in the Infections and Immunoepidemiology Branch (IIB). Many of these studies have been multi-centric and international, requiring sub-contracting and oversight of field activities in diverse locations. Over the past 5 years, IIB has expanded its portfolio of studies. This required the completion of pilot studies to assess the feasibility and to refine the study protocol for new studies, followed by scaling up of field activities once the main study was initiated. The SSC has provided critical support for many such studies, including a study in three countries in East Africa to study the etiology of Burkitt lymphoma (EMBLEM), a study in two regions of Taiwan designed to evaluate markers of H&N cancer risk among high-risk individuals with oral precursor lesions (THANCS), a study in Chile designed to elucidate markers of gallbladder cancer risk among high-risk individuals with gallstones (Chile BiLS), and a study in China to evaluate EBV-based screening for the early detection of nasopharyngeal carcinoma (NPC). In addition, the SSC has supported activities associated with ongoing efforts, including studies of Epstein-Barr virus (EBV), host genetics and NPC in Taiwan, continued follow-up of participants in the Costa Rica HPV-16/18 vaccine trial (CVT-LTFU), and the record linkage study of cancer following transplantation (TCM Study). Finally, the SSC has provided support to more targeted and methods studies, including studies of head and neck (H&N) cancers within the cohort consortium, record linkage studies in Scandinavia, and methods work to evaluate the fecal microbiome. Specific activities performed by the Contractor included the development of study questionnaires/forms and data entry and management systems, coordination and quality control of field activities (including the sub-contracting of field activities in international sites), regulatory support for ongoing studies, and assistance in procuring biological specimens for selected studies. In selected instances, consultants with expertise needed for Branch projects were contracted through this support mechanism. Through their involvement, the SSC has contributed to 75 papers during the latest contract period. Historically, support services contracts have provided an important mechanism to support research by investigators throughout the Division of Cancer Epidemiology and Genetics (DCEG). These contracts have complemented other mechanisms to enable efficient and effective implementation of studies within DCEG. The support services mechanism has been important for studies that are time sensitive and/or require coordination across multiple sites or institutions. Many of the studies that have benefited from this mechanism have been international and complex. Studies that involve large database linkage efforts across numerous institutions have benefitted from the existence of a support services Contractor to assist with the coordination of these large data management efforts. Molecular epidemiology studies that require careful collection, processing, monitoring and testing of biological specimens collected from select populations have also benefited from the support services mechanism. Finally, small, time-sensitive studies designed to address or follow-up important leads have relied heavily on the flexibility afforded by the support services mechanism. Studies Supported by the Infections and Immunoepidemiology Branch (IIB) Support Services Contract 1. Multi-centric/multi-institutional studies (often international) that require extensive coordination. 2. Focused studies designed to follow-up on important scientific discoveries and/or to capitalize on time-sensitive opportunities for studies in areas of relevance to the Branch. 3. Molecular studies nested within large, well-characterized collections that require careful selection of specimens for evaluation and close coordination of laboratory testing efforts. Specific Studies Supported: Chile Biliary Longitudinal Study (Chile BiLS) and related pilot work Project description: IIB investigators are conducting an 8-year cohort study (2 years for recruitment and 6 years of follow-up) of 6250 women with gallstones to investigate the etiology of and epidemiologic/molecular predictors of gallbladder cancer. This cohort study is complemented by the recruitment of 300 gallbladder cancer cases and 600 controls with and without gallstones for cross-sectional evaluations across the control-precursor-cancer continuum. The study is currently in its first year. Activities performed by the Support Services Contractor: Over the past 3 years, the Support Services Contractor played a central role in conducting a pilot study and the development of databases and protocols for the cohort study. Specifically, the contractor performed the following activities to support NCI investigators: • The development of study forms, protocols, and assistance with development of data entry and study management systems. • Communication with staff in Chile during the conduct of the pilot study and for preparation to launch the cohort study. • Administration of the Subcontract to support field activities. • Order and oversee supplies for collection and storage of biologic material. • Analytic support in the extraction of data from the database and the preparation of analysis datasets. Costa Rica HPV Vaccine Trial Project description: IIB investigators initiated the CVT in 2004 and its long-term follow up study roughly 5 years later. The funded project will last for 10 years total (ending in 2016/2017); we are currently seeking approval to extend follow-up of a subset of the current participants. In the current effort, we are actively following ~6000 women biennially, half of whom received the HPV vaccine and half who are followed with cervical cancer screening. At study visits, blood, cervical, anal and oral specimens are collected for the assessment of HPV (antibodies or DNA, depending on specimen collection). Activities performed by the Support Services Contractor: In the present contract period, the contractor was involved in the following activities in support of the CVT and CVT LTFU studies in Costa Rica: • Prepared IRB submissions and Data/Material Transfer Agreements. • Tracked and documented Adverse Event Reports. • Supported planning, materials management, and communication for the Working Group Meeting. • Managed the PEG portal, including organizing and posting content, and providing access. • Managed portal content and communication associated with ancillary analysis submissions. • Tracked the PBMC QC process and reported the results. • Prepared purchase orders. • Managed the new manuscript distribution process. EBV & NPC Studies in Asia Project description: IIB investigators have developed a research program focused on understanding the role of Epstein-Barr virus (EBV) and genetic factors in the development of nasopharyngeal carcinoma (NPC), and on the evaluation of EBV-based tests for the early detection of NPC. To accomplish our goals, in collaborations with colleagues at the National Taiwan University and the Academia Sinica in Taiwan, we have conducted two case-control studies (totaling close to 2,500 NPC cases and an equivalent number of controls) and a longitudinal multiplex family study (totaling over 3,000 individuals from 358 NPC multiplex families followed for over 10 years) in Taiwan. More recently, we initiated a collaboration with colleagues at the Sun Yat-Sen University Cancer Center to evaluate EBV-DNA testing of exfoliated nasopharynx cells and alternative NPC diagnostic procedures to improve performance of EBV serology-based NPC screening programs in China. This latter study includes approximately 1,400 individuals sampled from among >30,000 participants in an EBV-based NPC screening demonstration program sponsored by the Chinese government. Activities performed by the Support Services Contractor: In earlier contract periods, the contractor was involved in the development of materials and forms required for the studies in Taiwan, for coordination of field activities, for tracking and coordinating shipments for biospecimens from our various collections, and for building, editing and maintaining analytical datafiles. In the present contract period, the contractor was involved in the following activities in support of our studies in Taiwan and China: • Development of study materials and forms (China study) • Communication/coordination with international study sites (Taiwan and China studies) • Management of subcontracts to enable local study activities (Taiwan and China studies) • Selection and requisitioning of biological specimens for testing (Taiwan study) • Building, editing and maintaining analytical datasets (Taiwan study) • Analytical programming (Taiwan study) Epidemiology of Burkitt Lymphoma in East African Children and Minors (EMBLEM) Project description: IIB investigators are conducting a study of Burkitt lymphoma in East Africa with two sites each in Uganda, Kenya and Tanzania. The study, called EMBLEM, has broad goals of enrolling 1500 cases of BL and 3000 age, sex, and location-matched controls to study the effects of malaria infections, malaria genetic variants and EBV genetic variants with BL. Additional information about the study can be accessed at website: http://emblem.cancer.gov/. The study is currently in the 5th year of implementation. Activities performed by the Support Services Contractor: Over the past several years, the Support Services Contractor played a central role in coordinating logistical support to support EMBLEM field work. Specifically, the contractor performed the following activities to support NCI investigators: • Established and managed support subcontracts to support fieldwork in East Africa (Uganda, Kenya, and Tanzania) • Communicated with staff in East Africa (Uganda, Kenya, and Tanzania) during the conduct of the fieldwork through weekly, monthly, and quarterly and bi-ennial meetings • Ordered and shipped supplies and equipment required for collection and storage of biologic material in East Africa • Maintained property list of all study capital equipment • Collected monitoring data to keep track of key study deliverables • Coordinated bi-ennial standardization and harmonization meetings to insure high study quality Fecal Microbiota among NCI Employees Project description: IIB investigators have pioneered characterization of the microbial population (microbiota) of the distal gut and its associations with systemic estrogen levels, originally by collecting fecal and urine specimens, as well as questionnaire data, from NCI employee volunteers. Activities performed by the Support Services Contractor: In the summer of 2014, the Support Services Contractor served as the interim repository for the specimens collected from 62 study participants. Specifically, the contractor performed the following activities to support NCI investigators: • Provided space in and access for NCI staff to a -80C freezer in a laboratory close to the NCI offices. • Developed accessioning and inventory control procedures and forms. Head and Neck Tissue Study Project description: IIB Investigators are planning to obtain tumor samples from cases in the study of HPV16 antibodies and risk of HPV-driven cancers within the NCI Cohort Consortium Infrastructure. The goal of this project is to obtain tumors from multiple cohorts to test for HPV status, in order to correlate the tumor findings with the serologic data. Activities performed by the Support Services Contractor: In the previous contract period, the contractor worked with a single cohort to identify the relevant tumor specimens, developed a protocol for specimen shipment, coordinated the shipment of the samples (and prepared a manifest and pathology log for the included samples), helped construct and SOP for specimen processing, and coordinated the return of the tumor blocks to the cohort repository, as well as the shipment of daughter samples to the relevant labs. HPV Head and Neck Cohort Consortium Project description: IIB Investigators are studying the associations between HPV16 antibodies and risk of HPV-driven cancers within the NCI Cohort Consortium Infrastructure. The goal of this work is to coordinate the evaluation of this research question across roughly 20 cohort studies from around the world. This project is currently in its planning phase, as funding was only recently obtained. Activities performed by the Support Services Contractor: To date the contractor performed the following activities to support NCI investigators: • The development of study forms to assess availability of biospecimens by cohort, including harmonizing data assessment codes for cancer by anatomic site. • The Contractor managed the communication between study PIs and individual cohorts. • The Contractor summarized the data obtained from the cohorts for decision making. Natural History of Oral Cancer Precursors: A Prospective Cohort Study in Taiwan Project description: IIB investigators are conducting an 8-year cohort study (3 years for recruitment and 5 years of follow-up) of 3000 patients with oral cancer precursor lesions to investigate the rates of progression of precursors to severe dysplasia or higher as well as epidemiologic/molecular predictors of progression. This cohort study is complemented by the recruitment of 500 oral cancer cases and 500 clinic-based controls for cross-sectional evaluations across the control-precursor-cancer continuum. The study is currently in its first year. Activities performed by the Support Services Contractor: Over the past 3 years, the Support Services Contractor played a central role in conducting a pilot study and the development of databases and protocols for the cohort study. Specifically, the contractor performed the following activities to support NCI investigators: • The development of study forms, protocols, and InfoPath databases for data maintenance. • Communication with staff in Taiwan during the conduct of the pilot study and for preparation to launch the cohort study. • Administration of the Subcontract to support field activities. • Order and oversee supplies for collection and storage of biologic material. • Analytic support in the extraction of data from the database and the preparation of analysis datasets. Shanghai Biliary Tract Cancer Study Project description: The Shanghai Biliary Tract Cancer Study is a case control study of gallbladder, extrahepatic bile duct, and ampulla of Vater cancer cases, as well as ~1000 cholecystectomy patient and population-based controls. The study includes extensive data and biological specimens that were collected before the present contract period. Activities performed by the Support Services Contractor: In the present contract periods, the contractor was involved in building, editing and maintaining analytical datafiles and the selection and requisitioning of biological specimens for testing. Transplant Cancer Match Study Project description: The Transplant Cancer Match Study uses electronically linked data from the US solid organ transplant registry and multiple cancer registries to study the epidemiology of cancer in the U.S. transplant population. This study is the largest study of cancer risk in solid organ transplant recipients in the world. Participating cancer registries collectively provide data on approximately 45% of the U.S. transplant population through 2012, or approximately 251,000 transplant recipients. The study captures recipients of all organ types in each participating state or metropolitan region, so the included population is representative of the overall U.S. transplant population. Ongoing registry linkages provide updated data to monitor cancer trends and to expand the study into new geographic regions of the U.S. Activities performed by the Support Services Contractor: In the past several years, the contractor assisted with several organizational and managerial tasks. The following activities were performed: • Track progress on research projects utilizing data from the Transplant Cancer Match Study • Coordinate IRB approvals and renewals • Maintain a study internet portal to organize records and communications • Maintain a study bibliography • Create email lists to facilitate communications • Arrange teleconferences among study collaborators Purpose and Objectives: The purpose of this contract is the collection, processing, and analyze data, including biological samples, for the Infections and Immunoepidemiology Branch (IIB) through the use of technical, analytic, managerial, and clerical support. The successful Contractor shall function in a supportive role carrying out specific tasks and shall not engage in independent research. Any "designing" or "developing" mentioned herein does not imply research activities but shall be only for the purpose of supporting the staff of the NCI in support of the main objective. Project Requirements: A copy of the draft Statement of Work (SOW) pertaining to this requirement, which is subject to revisions, is attached to this notice. Anticipated Period of Performance: The anticipated period of performance inclusive of options, for this proposed acquisition is March 20, 2017 - March 19, 2022. A single award is anticipated. Capability Statement/Information Sought: Small businesses possessing experience and demonstrated capability to accomplish the aforementioned requirements and level of effort are to supply pertinent information in sufficient detail to demonstrate their ability to perform the required services. Information furnished must not exceed 15 pages (12-point font minimum), including all attachments, resumes, charts, etc.; and should include an outline of previous or similar projects performed. All responses must include an indication of current certified small business status, and clearly marked on the first page of the capability statement, as well as the eligible small business concern's name, point of contact, address, and DUNS number. Information Submission Instructions: All capability statements sent in response to this Small Businesses Sources Sought notice must be sent electronically (via email) to Kathleen Sears, Contracting Officer at searsky@mail.nih.gov in either MS Word or Adobe Portable Document Format (PDF) by March 7, 2016, 2:00 PM, EST. All responses must be received by the specified due date and time in order to be considered. CAPABILITY STATEMENTS RECEIVED AFTER THAT DATE AND TIME WILL NOT BE CONSIDERED. 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 responses. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
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