Small Business Sources Sought: US Pediatric Photon Therapy Comparison Cohort Study

Type of Notice: This is a Small Businesses Sources Sought notice (SBSS). 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; HUBZone 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 response 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. The NAICS code for this project is 541990. The small business size standard is $15M. Background: The Radiation Epidemiology Branch (REB), Division of Cancer Epidemiology and Genetics (DCEG), National Cancer Institute (NCI) carries out studies to quantify second cancer risks associated with ionizing radiation exposures in pediatric cancer patients. REB has a specific interest in the risk of second tumors following proton therapy in children, because the concern has been raised about whole-body scatter doses from neutrons, brain necrosis and other late effects including second tumors. NCI's primary aim is to add a comparison group of photon patients in order to quantify the subsequent cancer risks after proton compared to photon therapy. Subsequent cancers are one of the most common and serious adverse-effects of pediatric radiotherapy. Pediatric cancer is rare and therefore in order to assemble a comparison cohort of photon treated pediatric patients of adequate size, multiple pediatric treatment centers need to be recruited. No single center will likely have enough patients for the entire comparison cohort of 1000 or more patients. The contractor(s) shall provide a cohort of photon-treated pediatric cancer patients with detailed clinical and treatment data to serve as a comparison group for the evaluation of the risks and benefits of proton therapy for children. The contractor(s) shall select photon treated pediatric cancer patients for inclusion in the comparison cohort and collect required medical record and radiotherapy and imaging data from photon-treated pediatric cancer patients and upload the de-identified data to online data platforms (REDCap and MIM) maintained by the Pediatric Proton/Photon Consortium Registry (PPCR). Purpose and Objectives: The goal of this acquisition is to obtain data on a group of photon-treated pediatric cancer patients to serve as a comparison group to an existing cohort of proton-treated pediatric patients. Project Requirements: The contractor(s) shall select photon treated pediatric cancer patients for inclusion in the comparison cohort and collect required medical record and radiotherapy and imaging data from photon-treated pediatric patients and upload the de-identified data to online data platforms (REDCap and MIM) maintained by the Pediatric Proton/Photon Consortium Registry. The Contractor(s) shall perform the following tasks: 1. Study Subject Identification a)Select study subjects (photon-treated pediatric cancer patients), who were less than 22 years of age at diagnosis and treated with photons since 2006, for enrollment in the Pediatric Proton/Photon Consortium Registry (PPCR). b) Compile a roster of eligible study subjects at each study center. Study subjects shall be identified retrospectively of receiving treatment. c)Obtain all necessary IRB approvals in order to abstract clinical and treatment details for photon-treated pediatric cancer. 2. Data Collection a) Work with the PPCR in order to have a study ID assigned to each eligible study subject and obtain permission to upload de-identified abstracted data to REDCap. b) Abstract diagnosis and treatment data from medical records. Data elements to be abstracted are provided in the study protocol provided by NCI. c)Upload de-identified abstracted diagnosis and treatment data for the study subjects to REDCap. d) Verify a sample of 5% of abstracts by independent re-abstraction in order to provide quality control of the data abstraction. Provide documentation of the outcome of the re-abstraction to the PPCR. e) Obtain copies of de-identified photon diagnostic imaging and final treatment plans that may include CT structure, radiation treatment plan and dose files, and follow-up radiologic imaging studies as available for review by the PPCR dosimetrist. Assist the dosimetrist to unarchive original treatment plans, if needed. Anticipated Period of Performance: The anticipated period of performance, inclusive of options, for this proposed acquisition is July 2020 - July 2022. 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 20 pages (12-point font minimum), including all attachments, resumes, charts; 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: NCI is seeking capability statements from all eligible small businesses 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 All capability statements sent in response to this Small Business Sources Sought notice must be sent electronically (via email) to Lisa Bielen, Contracting Officer at lisa.bielen@nih.gov and Jill Johnson, Contracting Officer at jill.johnson2@nih.gov in either MS Word or Adobe Portable Document Format (PDF) by December 2, 2019; 2:00PM Eastern. 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 the information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised 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. Contracting Office Address: 9609 Medical Center Drive, Room 1E612, MSC 9705 Bethesda, Maryland 20892 United States Archiving Policy: Manual Archive Allow Vendors To Add/Remove From Interested Vendors: Yes Allow Vendors To View Interested Vendors List: No