Presolicitation Costa Rica 120423.pdf

Notice Type:

Pre-solicitation Notice

Note: This synopsis follows a Small Business Sources Sought notice that was released on April

5, 2022, under HHS-NIH-NCI-SBSS-ETSB-04

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

WILL BE ISSUED ON A LATER DATE.

Title: Epidemiology and Prevention of Infection and Related Diseases

Place of Performance:

Costa Rica

Background:

The Division of Cancer Epidemiology and Genetics (DCEG) of the National Cancer Institute

(NCI), in collaboration with investigators from several institutions in Costa Rica, have 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).

Ongoing studies of infectious agents in Costa Rica focus on the HPV vaccine evaluation efforts.

The next phase of the research and will cover the follow-up phase for the ongoing clinical trials evaluating HPV vaccines and dose regimes. Prior studies include, but are not limited to, Comparing One or Two Doses of the Human Papillomavirus Vaccine for the Prevention of

Human Papillomavirus Infection, ESCUDDO Study (ESCUDDO, NCT03180034); a 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); a 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).

The HPV vaccine evaluation studies include approximately 35,000 adolescents and women.

This procurement allows for the continued and extended follow-up of participants of all the studies. These studies will allow complete evaluation of HPV vaccination in different age cohorts and different dose regimes that can provide a comprehensive picture of the natural history of HPV and vaccine effectiveness in Costa Rica. Long-term follow-up of study participants will permit the evaluation of the long-term protection after HPV vaccination.

It is also anticipated that this requirement will provide support for conducting activities associated with the epidemiology and prevention of infections and related diseases of public health importance, such as SARS-CoV-2 and its variants, for which the infrastructure and methodology used within the HPV vaccination framework may be leveraged.

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. Secondary goals are 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 with 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:

Independently, and not as an agent of the Government, the Contractor shall furnish all necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the

Government.

The contractor shall:

TASK AREA 1: STUDY LIAISON

a) 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.

b) Obtain and maintain all necessary approvals and clearances for the storage, processing and testing of biospecimens from collaborating hospitals or institutions and appropriate agencies. This includes any required local institutional clearance, Ministry of Health approvals, International Organization for Standardization (ISO) 9001:2015 or higher

Certification, Good Laboratory Practices (GLPs), and any other scientific or administrative approvals required.

c) Obtain and maintain all necessary approvals and clearances for the retrieval of tumor blocks and, if necessary, retrieval of histology slides from collaborating hospitals or institutions and appropriate agencies. This includes any required local institutional clearance and any other scientific or administrative approvals.

d) Assist in arranging communications, transition activities, 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.

e) Attend and report on such meetings, provide all background material required, and act on recommendations in consultation with the COR.

f) 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.

g) 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

a) 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.

b) 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 PROPHYLACTIC

AND THERAPEUTIC VACCINE TRIALS AND NEW STUDIES OF INFECTIONS AND

RELATED DISEASES OF PUBLIC HEALTH IMPORTANCE

a) The contractor shall be able to identify potentially eligible participants to invite them to participate in the new studies; and, if required by the study protocol, obtain lists of

Minimal Geostatistical Units (MGUs) and be prepared to identify houses located in selected MGUs to identify and recruit potentially eligible participants.

b) 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.

c) 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

a) 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.

b) Conduct follow-up study procedures, including but not limited to, screening, diagnosis, and treatment procedures for cervical disease, according to the approved study protocol.

c) 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.

d) 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.

e) Document all contacts with study participants using study-specific forms.

f) 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

a) Procure study vaccines.

b) Provide vaccinations to eligible study participants.

TASK AREA 7: STORAGE AND HANDLING OF VACCINES

a) Design, implement and maintain a vaccine acquisition and supply plan.

b) Store and handle vaccines under proper conditions, including always maintaining cold chain conditions and chain of custody.

c) 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

a) Ensure appropriate day-to-day management of the local data and protect data.

b) Security requirement is to abide by Data Security Laws and practices of Costa Rica.

TASK AREA 10: TRAIN STAFF ON THE PROCESSING, STORAGE, AND SHIPPING

OF BIOLOGICAL SPECIMENS AND ON PERFORMING LABORATORY TESTS

a) Train staff on the processing, storage, and shipment of biological specimens (e.g., tissue, blood, plasma, serum, urine, and cervical and anal swab samples).

b) 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

a) Ensure appropriate day-to-day processing, testing, storage, and management of biospecimens and maintain SOPs to provide adequate disaster, back-up, and recovery mechanisms to ensure that the biospecimens 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 emergency response report within 3 days of the incident.

b) Prepare label IDs to be used in the clinics or at home at the time of biospecimen collection as instructed in the corresponding SOP.

c) Process and store all biological specimens collected as part of each study protocol. This will include but not be limited to the ability to process blood into its various components within a few hours of collection and to adequately preserve other biological specimens.

All aliquots must be stored in jacket tri-coded tubes to enable sample tracking and have automation capabilities.

d) Perform various laboratory tests, including but not limited to HPV 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

a) Ship and track study materials and biological specimens to the United States, or designated institution or laboratory 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).

b) Shipping biospecimens must meet 49 CFR requirements for proper packaging and shipping of biomedical materials or other applicable regulations.

c) 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 specimen damage 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:

a) 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.

b) 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.

c) 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.

d) Monitor and document the performance and progress of any work done under subcontract, if relevant.

e) Use applicable and common security practices for protecting data collected.

f) Develop and practice quality control procedures for the handling of the vaccine and of biological specimens collected.

g) Update the data 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:

a) 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.

b) Follow-up of study participants

c) Vaccination of study participants

d) Storage and handling of vaccines

e) Exit study participants

f) Tumor blocks and histology slides retrieval

g) Processing, storage, and testing of biological specimens

h) Shipment of biological specimens and transfer of electronic data

i) Other ad-hoc reports as requested by the COR.

TASK AREA 15: FINAL TRANSITION

In the final period of the task order the Contractor shall:

Develop and implement a Final Transition Plan to ensure the orderly, efficient, and smooth transition of all task order activities and materials to the COR at the end of the task order period. A Draft Transition Plan shall be submitted to the COR for review within six (6) months prior to the completion date of the study. The Final Transition Plan shall be submitted to the COR no later than four (4) months prior to the completion date of the 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 July 15, 2024. The anticipated ordering period for this

ID/IQ acquisition is July 2024 – June 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:

Michele Brown, Contract Specialist

Brownmiche@nih.gov

Secondary Point of Contact:

Kari Peterson, Contracting Officer kari.peterson@nih.gov http://www.sam.gov/ mailto:Brownmiche@nih.gov mailto:kari.peterson@nih.gov