Interdisciplinary Studies of Occupational and Environmental Cancer

This is a Small Business Sources Sought notice. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claim against the NCI shall arise as a result of a response to this Small Business Sources Sought Notice or the NCI's use of such information as either part of our evaluation process or in developing specification for any subsequent requirement. 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 the applicable NAICS code should not submit a response to this notice. A determination by the Government not to compete this requirement as a set-aside based upon responses to this notice is solely within the discretion of the Government. This requirement is assigned a code of 541990 in the North American Industry Classification System (NAICS), and the size standard for such requirements is $7 million. Background The National Cancer Institute (NCI), Occupational and Environmental Epidemiology Branch (OEEB) in the Division of Cancer Epidemiology and Genetics (DCEG), is anticipating re-competing a full and open competition contract for support for interdisciplinary studies. A major objective of DCEG is to identify and understand mechanisms of carcinogenesis. Occupational and environmental investigations play an important role in this effort because well-documented, high-level exposures to potential carcinogens occur in the workplace and because environmental exposures can impact a large segment of the population. The fundamental mission of the OEEB is to identify and clarify causes of cancer, with a focus on occupational and environmental exposures. To achieve its goals, OEEB's approach has been to (1) merge epidemiology, quantitative exposure assessment, and biologic and genetic components into multi-disciplinary investigations to identify carcinogens, clarify exposure-response relationships, and enhance our mechanistic understanding of carcinogenesis; (2) conduct investigations to develop and improve methods for exposure assessment and to evaluate and incorporate state-of-the-art biomarker assays into its molecular epidemiology studies; (3) facilitate the development of consortia to efficiently create scientific opportunities that are difficult to achieve in any one study; (4) develop and maintain resources for occupational and environmental epidemiology and exposure assessment; and (5) assist in training the next generation of occupational, environmental, and molecular epidemiologists. The philosophic focus of OEEB is to conduct high-impact epidemiologic studies that integrate quantitative exposure assessment and molecular epidemiology to provide new insights into cancer etiology, chemical carcinogenesis, and mechanisms of action. Approximately twenty-five studies will likely receive support under the contract. This work is currently being conducted under contract HHSN261200700044C held by Westat, Inc. Project Requirement This support services contract is essential for OEEB to conduct high-impact epidemiologic studies that integrate quantitative exposure assessment and molecular epidemiology to provide new insights into cancer etiology, chemical carcinogenesis, and mechanisms of action. The NCI/OEEB requires the assistance of an organization highly experienced in providing technical support for all phases of occupational and environmental epidemiologic studies, including support for exposure assessment and molecular components, and coordination of activities related to genome-wide association studies (GWAS); and in conducting and simultaneously managing concurrent, multiple, large (including international) epidemiologic investigations of cancer etiology. The contract will establish a mechanism to provide all the services required to conduct a wide variety of domestic and international and field (case-control, cohort, and cross-sectional) studies. Some of the major activities of the contract include: a. pilot test data collection forms and instruments, including computer-assisted personal (CAPI) and computer-assisted telephone (CATI) interviews; b. train interviewers and abstractors, including development of training documents under guidance of NCI; c. interview study subjects and their family; d. trace study subjects; including locating cancer patients and/or their relatives, selection of controls through such methods as random digit dialing and acquisition of appropriate study population rosters or files (e.g., departments of motor vehicles); e. abstract medical records and other relevant data sources; f. trace to determine vital status or locate subjects; g. obtain death certificates and cancer incidence records; h. obtain medical records; i. select appropriate molecular epidemiology procedures to understand cancer etiology with guidance from NCI; j. edit and maintain quality control and standardization of data to ensure appropriate and valid results; k. arrange for the collection, handling, transport, and storage of biologic, industrial hygiene and environmental samples; l. coordinate and monitor a biologic specimen program; m. prepare data management systems that monitor study progress and data flow; n. assess occupational and environmental exposures using various techniques, including (for the environmental assessment) geographic information systems; o. develop and monitor subcontracts; p. conduct coding of records, questionnaires and death certificates; q. prepare and maintain computer databases; r. provide documentation of study decisions and study procedure manuals; s. identify qualified industrial hygienists and exposure assessors; t. identify qualified laboratories to analyze biologic, industrial hygiene and environmental samples; u. develop files and reports of work to allow efficient and easy transfer of data and knowledge to the next support services contractor; v. develop coordination and liaison at the local or international level with collaborating investigators or institutions whose cooperation is needed for the conduct of a study w. close coordination of GWAS efforts with the relevant NCI repositories and laboratories, including trouble shooting all aspects of data and DNA sample preparation; prepare and maintain subject data logs and DNA manifests; selection of DNA samples for analysis based on review of pre-genotyping quality control reports; coordination of the post-GWAS replication efforts including selecting DNA samples for analysis; coordinating data collection and harmonization across studies for subsequent gene-environment interaction analyses; and preparation and QC/QA of phenotype data linked to GWAS data sets for submission to dbGaP. Capability Statement/Information Sought To be deemed capable of providing the current need for the study, the offeror shall submit a written capability statement demonstrating the ability and experience in performing the requirements noted in this notice. Organizations that submit capability statements in response to this notice will be evaluated against the following technical areas of experience and expertise: 1. Personnel and Organizational Experience: a. Demonstrated current experience in conducting and simultaneously managing concurrent, multiple, large (including international) epidemiologic investigations of cancer etiology b. Demonstrated current experience with oversight of large, complex contracts c. Demonstrated ability to respond quickly to changes in priorities and to supply support to urgent new efforts d. Proposed investigation team shall have experience in coordinating the collection of biologic specimens; using geographic information systems (GIS) for environmental exposure assessment; assessing occupational exposures; and coordinating GWAS efforts that might include 1-2 dozen studies. e. The offeror shall demonstrate how it will accomplish the task of attendance at face-to-face discussions as often as needed (typically weekly) and at times based on short notice, at the offices of the NCI in Rockville, MD. f. The offeror shall provide the name of the principal investigator, his/her professional qualifications and specific experience as a key investigator in large international cancer epidemiology studies with biospecimen collection, including blood, buccal cells, and tumor tissue. g. The offeror shall demonstrate that the proposed investigation team and staff have previous experience in carrying out population-based and hospital-based studies in multiple geographic areas, including subject identification and recruitment, design of data collection instruments, data collection, biospecimen collection and shipping, and coding (standard disease, occupational, and geographic) and keying of data. h. The offeror shall demonstrate the ability to hire, as needed, personnel such as phlebotomists, interviewers, abstractors, industrial hygienists, GIS specialists, and laboratory scientists. i. The offeror shall demonstrate that the proposed team and staff have previous successful experience in carrying out the requirements of the services stated herein and the activities listed above. 2. Facilities: The offeror shall have the necessary dedicated office space and accommodations to fulfill the requirements. The offeror shall demonstrate (1) the ability to store biologic, industrial hygiene, and environmental samples on a short-term basis, or the capability to secure support with other firms with such capabilities, (2) provision of a secure storage area for study materials, (3) evidence of telephone interviewing center capability and computer-assisted interview capability, and (4) computer capability for storing and processing geographical information system (GIS) software and databases. Anticipated Period of Performance The anticipated period of performance for this requirement is one year, with four one-year options. Submission Information Interested qualified small business organizations should submit a tailored capability statement for this requirement, not to exceed 20 single-sided pages (including all attachments, resumes, charts, etc.) presented in single-space and using a 12-point font size minimum, that clearly details the ability to perform the aspects of the notice described above. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement, as well as the eligible small business concerns name, point of contact, address and DUNS number. The NCI does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information received. All capability statements sent in response to this sources sought notice must be submitted electronically (via email) to Seena Ninan, Contracting Officer, at ninans@mail.nih.gov in MS Word or Adobe Portable Document Format (PDF), by December 20, 2011, 4:30PM, EST. All responses must be received by the specified due date and time in order to be considered. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. No collect calls or facsimile transmissions will be accepted. 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(s). Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation.