Presolicitation_Ukraine_7_28_23_1.pdf

Notice Type:

Presolicitation 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 28, 2023, under HHS-NIH-NCI-SS-ETSB-0036-01

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 Ukraine

Place of Performance:

Ukraine

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.

The scientific projects of this procurement are to study cancer and other health effects in radiation-exposed populations in Ukraine for two projects: Chernobyl Cleanup Workers Project, which is conducted by the National Research Center for Radiation Medicine (NRCRM), and the Ukrainian Thyroid and Breast Cancer Projects, which are conducted by the Institute of Endocrinology and Metabolism (IEM). These named institutes have direct Government mandated access to the study populations but in response to congressional inquiry and departmental review, the Government requires administrative and financial management, logistical support, and oversight of progress in field work, data/sample collection, data/sample transfer and analyses to ensure timely and successfully project advancements.

The study currently involves: (1) study of cancer mediators, precancer risks and other diseases following protractive external exposure to ionizing radiation in a Clinical Cohort of around 10,000 cleanup workers (primarily men) who participated in various recovery activities at the Chernobyl site; (2) monitoring changes in the thyroid glands in a cohort of about 16,000 persons exposed at young ages or in utero to Chernobyl fallout; (3) continuing creation of the cohort of women who lactating during exposure to 131I after the Chernobyl accident; and (4) support activities on biological sample collection and radiation dose reconstruction for Ukrainian individuals included in the Chernobyl Tissue Bank (CTB). The emphasis of this procurement is to conduct health effects studies in these cohorts and other potentially radiation-exposed populations in Ukraine.

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

Project Requirements:

A. Mandatory Requirement An offeror must provide a letter of intent with the initial proposal from the National Research Center for Radiation Medicine (NRCRM) and the Institute of Endocrinology and Metabolism (IEM) as proof of informal agreements between the Offeror and these collaborating institutes for the implementation of the health effects studies in radiation-exposed populations in Ukraine after the Chernobyl accident. In the letter, the collaborating institutes must also agree to execute a formal, signed agreement with the Offeror within 1 (one) month after the date of award of the contract.

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-Ukrainian binational project agreement to support collaborating institutions.

2. Provide administrative oversight of the studies conducted by collaborating institutions.

This will include evaluation and verification of the progress of project activities, materials, supplies, personnel, and services, auditing the costs, if deem necessary.

3. Coordinate and integrate all the Task Order activities including staffing decisions, prioritizing support for projects, and managing and monitoring activities of collaborating institutions.

4. Provide local office staff, who are fluent in English, Ukrainian and Russian, on-site administrative and financial management and oversight of the studies conducted by collaborating institutions.

5. Provide project planning and agreement, evaluation and verification of the progress of project activities, materials, supplies, personnel and services through close monitoring and auditing.

6. Provide income tax-free and fringe benefit-free payments made directly to the project staff doing the work at the collaborating institutions.

7. Provide the logistical support and procuring of duty-free customs clearance of purchases of equipment, materials and supplies to be made for the collaborating institutions in Ukraine or from outside the country.

8. Prepare and submit quarterly technical and financial reports as required, establishing a consistent method of invoicing and reporting that tracks labor hours 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.

9. Report to the NCI Contracting Officer’s Representative (COR) any significant managerial issues or problems and provide alternatives for resolution of the problems.

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

11. Manage the shipment of biological samples, including but not limited to, blood and buccal cell samples from Ukraine to the U.S. with obtaining appropriate government clearances for international shipping required for transferring biologic specimens and assure that they are appropriately cleared through customs.

12. Provide a brief description (inventory) of collected data and samples which were provided directly to the NCI by the collaborating institutions.

13. Work cooperatively with the NCI and the collaborating institutions in all relevant aspects of study development and execution to maximize cost-effectiveness and efficiency of the study. NCI will recommend the priority of the Task Orders and activities.

14. 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.

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 (i) perform all activities necessary to successfully manage the projects; (ii) respond to priority requests from the NCI Principal Investigator(s) (PIs) and NCI COR within 3 business days and to changes of study direction rapidly by appropriate activities and use of personnel; and (iii) inform the NCI PIs and NCI COR within 3 business days as it is aware of any unforeseen circumstances that may delay timely completion or progress of study activities.

All study activities, documents, and procedures must be approved by the NCI PIs and NCI COR prior to implementation.

The Contractor shall ensure that the Collaborating Institutions (i) respond to priority scientific requests and changes of study direction as requested by the NCI PIs and NCI COR by implementing appropriate activities; (ii) meet regularly with the NCI PIs and NCI COR in teleconference meetings to review contract and Task Orders performance and discuss project management issues and coordinate such meetings, provide required background material, prepare lists of action items, and take appropriate actions on recommendations, as applicable; and (iii) provide Internal Review Board (IRB) and ethical review committee documentation on an annual basis and as requested by NCI PIs.

TASK AREA 2: Subject Identification, Selection, and Tracing The Contractor shall ensure that the Collaborating Institutions (i) 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 PIs and NCI COR; (ii) use the different sources of data, including but not limited to the State Chernobyl Registry (SCR), the National Cancer Registry of Ukraine (NCRU), or other population rosters; (iii) based on criteria provided by the NCI PIs 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, locate and interview next-of-kin or other proxy respondents; and (iv) 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 provide administrative support and management for the Collaborating Institutions’ field activities of the studies, which may include travel arrangement. The Contractor shall ensure that the Collaborating Institutions (i) perform all activities necessary for data collection, including but not limited to the acquisition of demographical, medical, and health data with appropriate identifiers; (ii) interview subjects or surrogates using mail, telephone, computer-assisted, or personal interviews, and, if requested by the NCI PIs and NCI COR, verify a sample of completed questionnaires by re-interviewing subjects; (iii) conduct data link with the NUCR and the SCR to substantiate information on cancer and other diagnoses among study subjects; (iv) 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; and

(v) obtain all necessary pathology reports or other reports of cancer and other diseases for study subjects as requested by the NCI PIs and NCI COR.

TASK AREA 4: Data Preparation and Processing The Contractor shall ensure that the Collaborating Institutions (i) 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; (ii) update the database for the studies with information obtained from record linkage to the SCR and NBCR; (iii) maintain adequate backup of study data and secure storage, and deliver to NCI accurate, complete, and up-to-date electronic databases; (iv) make all necessary arrangements for transfer of data, including electronic transfers, and shipment of other material to the NCI PIs and NCI COR. Remove personnel identifiers, create study participant IDs, retain the key, and use a pseudonymized ID for data sharing/analysis as needed. The datasets sent to the NCI PIs should always be deidentified and checked to confirm all personal identifiers are removed; and (v) respond to data requests and questions concerning the studies populations and provide support to NCI PIs in their preparation of scientific papers.

TASK AREA 5: Radiation Dosimetry The Contractor shall ensure that the Collaborating Institutions (i) manage and support the dosimetry data previously collected on measurements in soil, milk, thyroid, as well as the radiation doses previously estimated for the collaborating post-Chernobyl studies with NCI; (ii) 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 PIs; (iii) 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; and (iv) 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. The datasets sent to the NCI PIs should always be deidentified and checked to confirm all personal identifiers are removed.

TASK AREA 6: Medical Screening The Contractor shall provide administrative support and management for the Collaborating Institutions’ activities on medical screening, which may include travel arrangement.

The Contractor shall ensure that the Collaborating Institutions (i) 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; and (ii) 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. The datasets sent to the NCI PIs should always be deidentified and checked to confirm all personal identifiers are removed.

TASK AREA 7: Specimen Collection with Samples The contractor shall (i) Oversee the Collaborating Institutes efforts to collect specimen; (ii) Manage the shipment of biological samples, including but not limited to, blood and buccal cell samples from Ukraine to the U.S. with obtaining appropriate government clearances for international shipping required for transferring biologic specimens and assure that they are appropriately cleared through customs; and (iii) Report immediately to the NCI PIs and NCI COR all irregularities, accidents, problems with temperature control connected with any specimen shipment from Ukraine to the U.S.

The Contractor shall ensure that the Collaborating Institutions cover three general areas: (i) 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; (ii) specimen storage and repository monitoring to ensure that storage vials and containers meet requirements on bar codes and storage temperature; (iii) report immediately to the NCI PIs and NCI COR all irregularities, delays, losses, deteriorations, unplanned thawing, accidents, mishandlings, errors, discrepancies, and inefficiencies connected with any specimen collection, processing, delivery, storage, or testing activity, as well as keep a computerized record of such problems; and (iv) preparing specimens for transport by aliquoting, labeling and batching, as needed.

TASK AREA 8: Pilot/Feasibility Studies The Contractor shall ensure that the Collaborating Institutions (i) support feasibility or pilot studies or other means to enable a decision about undertaking a full study; (ii) in coordination with the NCI PIs 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;

(iii) report the feasibility of performing linkages to a variety of sources to define vital status, cancer status, medical history, census tract residence, etc.; and (iv) 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 April 1, 2024. The anticipated ordering period for this indefinite delivery indefinite quantity acquisition is April 2024 – March 2034.

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

Secondary Point of Contact:

Karins Peterson Contracting Officer Kari.peterson@nih.gov http://www.sam.gov/ mailto:Kristi-jo.noel@nih.gov mailto:Kari.peterson@nih.gov