Coordinating Center for Continuation of Follow-Up of DES-Exposed Cohorts

Type of Notice: This is a Small Businesses 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 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 National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG) research focuses on discovering genetic and environmental determinants of cancer and identifying new approaches to cancer prevention. This project is for the re-competition of contract HSN261201600032C with Westat, Inc., which was awarded on a competitive basis for a five-year period. This Small Business Sources Sought (SBSS) is for information and planning purposes only and shall not be construed as an obligation on the part of NCI. Purpose and Objectives: The purpose of the DES Exposed Cohorts Follow-up Study, as required by congressional mandate under the DES Research and Education legislation, is to continue to monitor individuals participating in studies of DES for cancer risk, non-reproductive conditions, and mortality; to coordinate and support collection of blood samples from the cohort members; and to continue to survey the reproductive experience of granddaughters and possibly grandsons. - Monitor the cancer incidence among the DES exposed daughters, sons, granddaughters and grandsons, with focus on cancers of the breast, uterus, ovary, prostate, pancreas, and colon and rectum. - Monitor the mortality of mothers, daughters and sons. - Coordinate the collection of blood samples from cohort members performed by the sites. - Continue to evaluate differences in reproductive experience among the granddaughters. - Support and assist with sub-studies as appropriate. NCI is seeking capability statements from all eligible small business concerns in performing the tasks/duties herein. Based on the responses received from this SBSS notice, the proposed project may be solicited as a Small Business Set-Aside. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against 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 specifications for any subsequent requirement. Project Requirements: Specific tasks to be performed by the Contractor include the following: A. Liaison 1) Establish contact with each of the six field centers selected by NCI. Request personal identifiers from the sites that are willing to allow passive follow-up by the contractor. Work with the sites that are unwilling to share personal identifiers to support passive follow-up. 2) Establish contact and coordinate activities as needed with NCI's computer programming support services contractor. 3) Establish contact and coordinate activities with NCI's biorepository. 4) Assist in arranging communications or meetings, as needed, between the NCI Contracting Officer Representative and field center staff. 5) Attend and report on such meetings, provide background materials as needed and act on recommendations in consultation with the NCI Contracting Officer Representative. 6) Respond to queries from NCI Contracting Officer Representative. Meet in-person or by phone with NCI Contracting Officer Representative at least quarterly. B. Development of Study Materials and Manuals 1) Develop and update procedure manuals for the study, in collaboration with the NCI Contracting Officer Representative and field center staff. Work with field centers and NCI Contracting Officer Representative to establish standardized procedures for each of the sub-studies. 2) Assist field centers in developing one newsletter to be sent to cohort members. 3) Maintain and update the study web site (http://www.desfollowupstudy.org/). C. Data Preparation and Processing 1) Coordinate and conduct National Death Index searches to determine vital status. Assist in reconciliation of vital status using available sources. Coordinate and conduct state cancer registries searches. 2) Coordinate State Cancer Registry searches to ascertain cancer status. 3) Coordinate the study sites' effort to collect blood from participants. This includes: - Providing sites with study materials (e.g., questionnaire which will be developed by NCI) - Training sites for blood collection effort and responding to questions - Coordinating with NCI's computer programming support services contractor to provide lists of eligible participants to the sites - Receiving questionnaire and other data from the study sites 4) Edit and correct computer files as needed. 5) Maintain a master study file with vital status and response to 1994, 1997, 2001, 2006, 2011, and 2016 follow-up questionnaires, as well as all information obtained from linkage with registries (e.g., NDI, cancer registries) and respond to requests by NCI Contracting Officer Representative. 6) Transmit computerized data files containing edited, corrected data to the NCI Contracting Officer Representative or representative at the completion of each wave of follow-up, or as appropriate. 7) Assist the study centers in ad hoc investigations that arise from the standard data collection. D. Monitoring, Information Management, Reporting and Documentation 1) Utilize a computerized information system to monitor the progress of data collection. 2) Initiate regular monthly telephone calls to the field centers to monitor progress and address problems during the data collection phases of the study. 3) During the data collection phases of the study, receive final reports from the field centers and provide them to the NCI Contracting Officer Representative for review. During data collection phases, on a quarterly basis, create a combined report from all the field centers to monitor the overall progress of the study. 4) Document all the individual steps in the study and maintain orderly files of all relevant materials, so that any aspect of the study can be reviewed and evaluated by NCI staff at any time during the study. Included are the following: i. Maintain a filing system of all relevant materials, cross-referenced to permit easy access. These materials shall be stored in accordance with requirements of the Privacy Act. ii. Maintain a log of all decisions made during the study that pertain to study design, conduct, and analysis. Examples of such decisions are criteria for selecting individual cohort members for participation in sub-studies, and coding decisions for questionnaires and medical records. Anticipated Period of Performance: The anticipated period of performance inclusive of options, for this proposed acquisition is March 29, 2021 - March 28, 2026. 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 Culver Clark, Contract Specialist at culver.clark@mail.nih.gov in either MS Word or Adobe Portable Document Format (PDF) by May 13, 2019, 1:00 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 response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation.