Epidemiology and Prevention of Infections and related diseases

Type of Notice: This is a Small Business Sources Sought (SBSS) 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; 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 541715. The small business size standard is 1,000 employees. Background: Division of Cancer Epidemiology and Genetics (DCEG) of the National Cancer Institute (NCI), in collaboration with investigators from several institutions in Costa Rica, has conducted studies regarding cervical cancer, Human Papillomavirus (HPV) infection, and the epidemiology and prevention of infections and related diseases of public health importance (e.g., SARS-CoV-2). This SOW describes activities related to our ongoing studies of infectious agents in Costa Rica, specifically NCI's HPV vaccine evaluation efforts which are required for the next phase of the research and will cover the follow-up phase of the ongoing clinical trials evaluating 1 versus 2 doses of the HPV vaccines, such as Comparing One or Two Doses of the Human Papillomavirus Vaccine for the Prevention of Human Papillomavirus Infection, ESCUDDO Study (ESCUDDO, NCT03180034); Single Dose of Cervarix Vaccine in Girls or Three Doses of Gardasil Vaccine in Women for the Prevention of Human Papillomavirus Infection, the PRIMAVERA-ESCUDDO Trial (PRIMAVERA, NCT03728881); Single-dose HPV Vaccination among young adult women in Costa Rica: the PRISMA-ESCUDDO Trial (PRISMA, NCT05237947); the NCI Costa Rica Vaccine Trial (CVT, NCT00128661); and the Costa Rica Corona Virus Serology Study (CVS, DCC-AI-20071-01). These studies are currently under contract HHSN261201700012I. Purpose and Objectives: The objective is to build a comprehensive body of evidence evaluating HPV vaccine protection for adolescents and adults. The ultimate goal is to make huge advances towards controlling cervical cancer globally in the next decade. NCI also aims to study the epidemiology and prevention of infections and related diseases of public health importance using the infrastructure and methodology developed within the HPV vaccination framework. The Contractor shall be the liaison, prepare study materials and forms, train staff, follow-up study participants, conduct screenings, provide a diagnosis, and treatment procedures for cervical disease, enter and maintain data, collect biospecimens and data, store specimens, ship biological specimens, conduct sample testing, and provide study monitoring. In addition, the Contractor shall enroll and follow, if required, participants in new studies of HPV infection and related diseases of importance to public health. Project Requirements: The Contractor shall: Task Area 1: Liaison Obtain and maintain all necessary approvals and clearances for the studies from the collaborating institutions and appropriate agencies within Costa Rica. This includes any required local institutional review board clearance, Costa Rica Ministry of Health approvals, and any other scientific, administrative, or ethical approvals required. Obtain and maintain all necessary approvals and clearances for the testing of biospecimens from the collaborating institutions and appropriate agencies. This includes any required local institutional clearance, Ministry of Health approvals, International Organization for Standardization (ISO) Certification, Good Laboratory Practices (GLPs), and any other scientific or administrative approvals required. Assist in arranging communications or meetings as needed, including those between the NCI research investigators and the collaborating or supporting agencies for those parties whose cooperation or approval is necessary. Attend and report on such meetings, provide all background material required, and take action on recommendations in consultation with the COR. Provide for continued liaison between the NCI COR and scientific collaborators in Costa Rica and elsewhere as appropriate throughout the course of the study about study progress and problems. Conduct educational, information, and public health promotion campaigns in the local Costa Rican community to inform the population of the study and its progress, as needed to maintain good stature in the community. Task Area 2: Preparation of Study Materials and Forms to monitor participants during the Follow-up phase Update and maintain forms for the ongoing and new studies, as well as other materials to be used in the studies. This shall include informational brochures, questionnaires, and other study forms and Standard Operating Procedures (SOPs) for study-specific activities. Translate materials from English to Spanish and/or from Spanish to English, as required by the NCI COR. Task Area 3: Train staff to perform the activities related to the Recruitment, Enrollment, and Follow-up of study participants Train staff on recruitment, enrollment, and follow-up procedures of different vaccine trials and new studies of epidemiology and prevention of infections and related diseases of public health importance. Task Area 4: Recruitment of participants for new Vaccine Trials and new studies of infections and related diseases of public health importance The contractor shall obtain lists of Minimal Geostatistical Units (MGUs) and be prepared to identify houses located in selected UGMs to identify potentially eligible participants to invite them to participate in the new studies. Obtain informed assent among people <18 years of age and informed consent for people 18 years of age or older. Additionally, obtain informed consent from the parent/legal representative of minors who assented to the study. Obtain informed consent from all participants who become 18 during the study. Conduct study procedures, including but not limited to, conducting screening, diagnosis, and treatment procedures for cervical disease, and collecting biospecimens from study participants at the time of the study visit(s) as specified in the study protocol. Task Area 5: Follow-up of Study Participants Reasonably attempt to interview active trial participants on a semiannual or annual basis, according to the study procedures. Specifics of the follow-up are provided as part of the approved study protocol for each study. Conduct screening, diagnosis, and treatment procedures for cervical disease, according to the approved study protocol. Collect biospecimens from all willing participants at the time of the follow-up visit, as per the corresponding study protocol and as requested by the NCI COR. Ensure that biological specimens collected from participants during the specific studies shall be sent to a designated laboratory for processing and testing, as specified by the NCI COR. Document all contacts with study participants using study-specific forms. Institute procedures to maximize study participation and retention. These efforts shall include but not be limited to, informational campaigns to inform the community about the study, mailings to participants, home visits by outreach workers, reimbursement of transportation costs to and from the study clinics, and establishment of periodic clinics in the different study areas. Task Area 6: Vaccination of Study Participants Procure study vaccines. Provide vaccinations to eligible study participants. Task Area 7: Storage and Handling of Vaccines Design, implement and maintain a vaccine acquisition and supply plan. Store and handle vaccines under proper conditions, including always maintaining cold chain conditions and chain of custody. Provide adequate temperature monitoring devices, security, alarm, and back'up systems to assure that vaccines are maintained at the correct temperature. Task Area 8: Exit Study Participants Exit study participants according to established procedures, as specified in the study protocol. Task Area. 9: Data Preparation, Entry, and Maintenance of Data Management System Ensure appropriate day-to-day management of the local data and provide adequate disaster, back-up, and recovery mechanisms to ensure that data is not lost. Implement and expand, as needed, the network of computers and related hardware, as well as the data management system, needed for the studies. Task Area. 10: Train Staff on the Processing, Storage, and Shipping of Biological Specimens and on Performing Laboratory Tests Train staff on the processing, storage, and shipment of biological specimens. Train laboratory staff on the different procedures to conduct testing of samples collected from the HPV Vaccine studies and studies of infectious diseases of importance to public health, as specified by the NCI COR. Task Area. 11: Processing, Storage, and Testing of Biological Specimens Ensure appropriate day-to-day processing, testing, storage, and management of samples and maintain SOPs to provide adequate disaster, back-up, and recovery mechanisms to ensure that the samples are not damaged. In the event of an emergency, the Contractor shall notify the COR by phone and e-mail within 72 hours of any emergency affecting the status of the biospecimens contained in the onsite repository. The Contractor shall follow up on all emergencies affecting the status of biospecimens with a written report within 3 days of the incident. Perform various laboratory tests, including but not limited to HPV testing, Qubit testing, utilizing biological specimens collected from participants. These tests shall be performed as specified in the standard operating procedure. Task Area. 12: Shipment of Biological Specimens and transfer of electronic data Ship and track study materials and biological specimens to the United States according to established procedures, as requested by NCI COR. This may include shipments at room temperature and in frozen states (including dry ice and liquid nitrogen). Shipping biospecimens must meet 49 CFR requirements for proper packaging and shipping of biomedical materials or other applicable regulations. The Contractor shall notify the COR within 72 hours by phone or email of any issues with biospecimen shipments received or received at a recipient location in a damaged condition or in which the research value of the biospecimens may have been compromised (e.g., thawed condition). The Contractor shall submit a written report within 7 calendar days that describes the specimens and studies affected, a description of the finding, and any follow-up action taken or needed. Task Area. 13: Study Monitoring, Quality Control, and Reporting Quality control shall require that the Contractor: Document each step in the study and maintain, in an orderly arrangement, all relevant material so that any aspect of the study may be reviewed and evaluated by the NCI COR at any point in time. Develop and employ internal record-keeping procedures for assessing the progress and status of data collection, preparation, and entry. This shall include, but not be limited to, careful maintenance of a log of decisions made during the course of the study and the development of range and logic edits as needed to ensure data quality. Develop and utilize internal audit and performance review procedures. This shall include, but not be limited to, plans for resolving problems uncovered during routine audits. Monitor and document the performance and progress of any work done under subcontract, if relevant. Use applicable and common security practices for protecting data collected. Develop and practice quality control procedures for the handling of the vaccine and of biological specimens collected. Update the data management system in a timely manner to assure rapid and timely access by the NCI COR to study data. This shall include, but not be limited to, the rapid reporting to the NCI COR of significant adverse event data and other data required by the NCI COR or the study data safety and monitoring board. Task Area. 14: Reports The Contractor shall prepare reports, as specified in the deliverables, to monitor activities related to: Recruitment targets of HPV Vaccine Trials and other HPV-related studies, and of new Vaccine Trials and new studies of infections and related diseases of public health importance. Follow-up of study participants Vaccination of study participants Storage and handling of vaccines Exit study participants Processing, storage, and testing of biological specimens Shipment of biological specimens and transfer of electronic data Other ad-hoc reports as requested by the COR. Anticipated Period of Performance: It is anticipated that single Indefinite Delivery Indefinite Quantity (IDIQ) contract will be awarded with a ten year period of performance beginning on or about August 2023. Capability Statement/Information Sought: Interested qualified small business organizations should submit a tailored capability statement for this requirement, not to exceed 5 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 as well the personnel. As well as organizational and past experiences in conducting and managing large scale international longitudinal studies involved in recruitment. In addition, discuss the adequacy of clinical facilities. 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. Information Submission Instructions: All capability statements sent in response to this Small Businesses Sources Sought notice must be sent electronically (via email) to Michele Brown, Contract Specialist at brownmiche@mail.nih.gov and Rukshani Levy, Contracting Officer at rukshani.levy@nih.gov@nih.gov in either MS Word or Adobe Portable Document Format (PDF) by Monday, April 21, 2022 at 2:00 PM, EST. All responses must be received by the specified due date and time in order to 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.