Presolicitation_GU_RNPTS_1.pdf

Notice Type:

Pre-solicitation Notice

Classification Code:

R -- Professional, administrative, and management support services

NAICS Code:

541 -- Professional, Scientific, and Technical Services/541715 -- Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Note: This synopsis follows a Small Business Sources Sought notice that was released on March 21, 2023 under HHS-NIH-NCI-SS-ETSB-0035-01

THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSALS. A SOLICITATION

WILL BE ISSUED ON A LATER DATE.

Title: Cancer and Other Health Effects Following the Chernobyl Accident in Belarus

Place of Performance:

Belarus

Background:

The Chernobyl Research Program (CRP), Radiation Epidemiology Branch (REB), Division of Cancer Epidemiology and Genetics (DCEG), National Cancer Institute (NCI) is responsible for studies in radiation effects on cancer and other diseases. CRP/REB/DCEG develops, administers, and evaluates a contract-supported applied research program.

This requirement describes activities related to the study of cancer and other health effects in Belarus, a large-scale epidemiological study detecting thyroid and other pathology in persons who have been exposed to radiation as released by the accident at the Chernobyl Nuclear Power Station on April 26, 1986. The study currently involves three cohorts: (1) the Belarusian- American (“main”) cohort that was established in the late 1990s and consists of 11,732 subjects who were age 18 or under at the time of the accident, had their dose to the thyroid gland measured, and lived in the Chernobyl affected areas in Belarus; (2) the Belarusian in-utero (“in-utero”) cohort that was established in 2017 and consists of 2,965 persons who were exposed to Chernobyl fallout radiation in-utero and early post-natal life; and (3) a cohort, which is currently under construction, of women whose children were born between January 1, 1985 and June 30, 1986, including mothers of the main and in utero cohorts, and others who were potentially exposed to Chernobyl fallout during pregnancy or lactation. The emphasis of this procurement is to conduct health effects studies in these cohorts and other potentially radiation-exposed populations in Belarus.

Purpose and Objectives:

The goal of this procurement is to conduct health effects studies in these cohorts and other potentially radiation-exposed populations in Belarus.

Project Requirements:

A. Mandatory Requirement An offeror must provide an official Order from the Ministry of Health of Belarus. This Order must designate the Offeror’s institution as the leading institution for the implementation of the scientific protocol for the study of thyroid cancer and other thyroid diseases in Belarus after the Chernobyl accident.

B. General Task Order Requirements Independently, and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to simultaneously manage concurrent, multiple, in country and international studies.

The following requirements shall apply to each Task Order. The contractor shall:

1. Provide support maintaining a United States-Belarusian binational project agreement to support collaborating institutions.

2. Coordinate and integrate all Task Order(s) activities including staffing decisions and prioritizing support for projects.

3. Ensure quality assessment and quality control of the work performed; foster excellent internal/external communications; track projects; and monitor the budget. The contractor shall report this work by preparing and submitting scientific, technical, and financial reports and datafiles as required.

4. Prepare and submit quarterly technical and financial reports as required; establish a consistent method of invoicing; report the tracking of labor hours (when required) to a study/project identifier and to the requestor; and provide detailed reports of the work completed within the period-of-performance. This method should be flexible to accommodate for any changes to the Government’s business needs that may occur in the future.

5. Report to the NCI, Contracting Officer’s Representative (COR) any significant managerial issues or problems and provide alternatives for resolution of the problems within 2 business days.

6. Provide support in procuring materials and supplies, and compensation to study subjects as needed in performance of the tasks as outlined in the Scope and Description sections of each Task Order and approved by the NCI COR.

7. Coordinate training and certification applicable to this work for in-house study staff as required.

8. Ensure that data security and confidentiality requirements are met.

9. Work cooperatively with the NCI in all relevant aspects of study development and execution to maximize cost-effectiveness and efficiency of the study as well as prioritize the order of tasks and activities.

10. Respond to data requests and questions concerning the studies and provide support to NCI PIs in their preparation of scientific papers. No personally identifiable information (PII) should be transferred to NCI in any of the task areas that include the transfer of data (e.g., no names, birth year/month only).

Description of Work for Individual Task Area (Technical Requirements):

The Contractor shall coordinate and integrate all activities including staffing decisions, prioritizing support for projects, and managing and monitoring task orders which will include one or more of the task areas as defined below. The Contractor performs the activities necessary to fulfill the requirements of the task(s) and shall provide specialized skills, such as development of forms, interviewer training, and tracing for vital status.

The eight major Task Areas which the Contractor shall provide are as follows:

1. Project Management

2. Subject Identification, Selection, and Tracing

3. Data Collection for Ongoing and New Studies

4. Data Preparation and Processing

5. Radiation Dosimetry

6. Medical Screening

7. Specimen Collection with Samples

8. Pilot/Feasibility Studies

TASK AREA 1: Project Management The Contractor shall perform all activities necessary to successfully manage the projects. The Contractor’s management (Project Director, Project Administrator and Contractor Key Personnel) shall meet regularly with the NCI Principal Investigator (PI) and NCI COR in teleconference meetings to review contract and Task Orders performance and discuss project management issues. The Contractor shall coordinate and attend such meetings, provide required background material, prepare lists of action items, and take appropriate actions on recommendations, as applicable. The Contractor shall respond to priority scientific requests and changes of study direction as requested by the NCI PI and NCI COR by implementing appropriate activities and use of personnel. The Contractor shall provide Internal Review Board (IRB) and ethical review committee documentation on an annual basis and as requested by NCI PI. The Contractor shall provide the Transition Plan that provides a detailed description of the procedures to be used to ensure the orderly and timely transition of studies, transfer of relevant electronic and hard copy files, records, materials, and documentation, for transferring work from this contract to the Government; a draft shall be submitted to the NCI COR for review six (6) months before the end of contract period of performance or the latest Task Order period of performance, whichever is later.

TASK AREA 2: Subject Identification, Selection, and Tracing The Contractor shall perform all activities necessary to identify, select, and trace the study subjects who meet the NCI criteria for inclusion in studies as approved by the NCI PI and NCI COR. The Contractor shall use the different sources of data, including but not limited to the State Chernobyl Registry (SCR), the National Belarusian Cancer Registry (NBCR), the Contractor records, or other population rosters. The Contractor shall, based on criteria provided by the NCI PI and NCI COR, trace study subjects and contact them to determine eligibility, introduce the study, ascertain their vital status, invite participation, and obtain other information necessary to meet study objectives. For deceased or incapacitated subjects, if necessary, the Contractor shall locate and interview next-of-kin or other proxy respondents. The Contractor shall conduct and monitor subject enrollment and response rates as needed as well as identify strategies or systems to improve case ascertainment and subject participation rates for minority and underserved populations.

TASK AREA 3: Data Collection for Ongoing and New Studies The Contractor shall perform all activities necessary for data collection, including but not limited to the acquisition of demographical, medical, and health data with appropriate identifiers. The Contractor shall conduct, support, and manage interviewing subjects or surrogates using mail, telephone, computer-assisted, or personal interviews, and, if requested by the NCI PI and NCI COR, verify a sample of completed questionnaires by re-interviewing subjects. The Contractor shall conduct data link with the NBCR and the SCR to substantiate information on cancer and other diagnoses among study subjects. The Contractor shall use tracing management systems to maximize participation and reduce loss rates for all data collection efforts as well as manage systems to describe document control for best name, date of birth, last known address, and last known vital status with appropriate dates. The Contractor shall obtain all necessary pathology reports or other reports of cancer and other diseases for study subjects as requested by the NCI PI and NCI COR. The Contractor shall make all necessary arrangements for transfer of data, including electronic transfers, and shipment of other material to the NCI.

TASK AREA 4: Data Preparation and Processing The Contractor shall develop and establish a master database for data recorded on the studies and data forms, including but not limited to laboratory and clinical information, blood collection and processing form, medical examination forms, prior medical history form, laboratory blood examination form, hospitalization form, pathological examination form, and report on adverse medical event. The Contractor shall update the database for the studies with information obtained from record linkage to the SCR and NBCR. The Contractor shall maintain adequate backup of study data and secure storage, and deliver to NCI accurate, complete, and up-to-date electronic databases.

TASK AREA 5: Radiation Dosimetry The Contractor shall perform all activities necessary for radiation dosimetry of the studies. The Contractor shall manage and support the dosimetry data previously collected on measurements in soil, milk, thyroid, as well as human-like phantoms or NCI-developed software, as appropriate, in the estimation of radiation doses to specific organs (or sites within organs) following environmental and man-made sources of exposures for ongoing epidemiologic studies. The Contractor shall manage and support the radiation doses previously estimated for the collaborating post-Chernobyl studies with NCI. The Contractor shall manage and support calculations to estimate the radiation organ-specific absorbed doses and associated uncertainties in doses for the study subjects as specified by the NCI PI. The Contractor shall provide the comparison between the measured doses and the doses calculated using dose reconstruction programs for a sample of the study subjects to validate consistency and accuracy of estimated doses. The Contractor shall prepare the written description of the final methodology that was employed in the estimation of organ doses and associated uncertainties for individuals in each study and prepare and provide a data file with dosimetry results to the NCI.

TASK AREA 6: Medical Screening The Contractor shall perform all activities necessary for conducting medical screening of study subjects using fixed and mobile teams using the study protocol and operations manual approved by NCI. The Contractor shall manage up-to-date master database with data from the medical screening, including data recorded on the study and data forms including but not limited to laboratory and clinical information, blood collection and processing form, medical history form.

TASK AREA 7: Specimen Collection with Samples The Contractor shall cover three general areas: 1) collection of biological and environmental specimens, including (but not limited to) peripheral venous blood, saliva, buccal cells, urine, tumor tissue, teeth, soil, breast milk, and other tissue from consenting study subjects; 2) specimen storage and repository monitoring to ensure that storage vials and containers meet requirements on bar codes and storage temperature; and 3) preparing specimens for transport by aliquoting, labeling and batching, as needed.

TASK AREA 8: Pilot/Feasibility Studies The Contractor shall support feasibility or pilot studies or other means to enable a decision about undertaking a full study. The Contractor shall, in coordination with the NCI PI and NCI COR, identify study subjects who meet the NCI criteria for inclusion in studies and explore the feasibility of alternative selection and sampling schemes as necessary; manage and support the preparation, pretesting, printing, and evaluation of data collection forms. The Contractor shall report the feasibility of performing linkages to a variety of sources to define vital status, cancer status, medical history, census tract residence, etc. The Contractor shall support feasibility studies for collection of dosimetry data (literature review of dose estimates from similar study populations, results of measurements of environmental and biologic samples as well as humans, methodology used for organ dose estimation and associated sources of uncertainty) to enable a decision about undertaking dosimetry for a full study.

Additional Information:

The services will be acquired through full and open competitive procedures under NAICS 541715. The Government anticipates that one, Indefinite Delivery/Indefinite Quantity (ID/IQ) type contract will be awarded on or before February 14, 2024. The anticipated ordering period for this indefinite delivery indefinite quantity acquisition is February 2024 – January 2034. One, fixed price task order will be issued against the base contract concurrent with the award of the

IDIQ.

The solicitation will be available electronically at a later date and may be accessed through Contract Opportunities at www.SAM.gov. WE ENCOURAGE ALL RESPONSIBLE

SOURCES, PARTICULARLY SMALL BUSINESSES, TO SUBMIT A PROPOSAL

WHICH WILL BE CONSIDERED BY THE AGENCY. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile or email transmissions will be accepted. It is the offeror’s responsibility to monitor the above-mentioned site for the release of the solicitation and any amendments.

Primary Point of Contact:

Kristi-Jo Noel, Contract Specialist Kristi-jo.noel@nih.gov http://www.sam.gov/