Sol_Doc_75F40125Q00337.pdf

Food and Drug Administration (FDA)

Center for Biologics Evaluation and Research (CBER)

Solicitation #: 75F40125Q00337

Transfusion-Transmissible Infections Monitoring System (TTIMS)

1. Statement of Work (SOW)

1.1 Background

The U.S. Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, tobacco products, our nation’s food supply, cosmetics and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines, devices, products, and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

Extensive epidemiologic research on many targeted aspects of transfusion safety has been conducted over the past several decades in the United States. In particular, the (NIH) National Heart Lung, and Blood Institute (NHLBI) Retrovirus Epidemiology Donor Study-II (REDS-II) made a seminal contribution to blood safety monitoring through refinement of procedures for the centralization of proprietary blood center operational data, successful coordination of standardized data definitions, and collection, analysis, and reporting of baseline epidemiologic and risk factor data for a large segment of the United States (US) donor base. The progress by REDS-II led to a recommendation from the Department of Health and Human Services for establishment of “an ongoing, integrated, coordinated, and nationally representative U.S.

transfusion transmissible infections monitoring system.” In response, the US Transfusion-Transmissible Infections Monitoring System (TTIMS) began data collection on September 1, 2015 under the sponsorship of the Food and Drug Administration (FDA), the NHLBI, and the Department of Health and Human Services, Office of the Assistant Secretary of Health (DHHS/OASH).

TTIMS was established for the specific purpose of monitoring the incidence and prevalence of transfusion-transmissible infections among U.S. blood donors, focusing on threats from the major transfusion-transmissible infections: Human Immunodeficiency Virus (HIV), Hepatitis C (HCV), and Hepatitis B (HBV) during times of changes in the epidemiology of these agents in the US general population, as well as the changes in blood collection and manufacturing policies and procedures. Syphilis was added into TTIMS monitoring in October 2020. If and when new scientific data regarding blood safety emerge from any source, TTIMS will also maintain the capability to investigate additional emerging or re-emerging infectious threats to blood safety as well as donor attributes that may be associated with increased or decreased levels of risk.

Since September 1, 2015, TTIMS has monitored approximately 60% of the US blood supply and has collected and analyzed data from 56,041,861 blood donations by 15,841,010 individual donors appearing at four major US blood centers. Relevant HIV, HCV, HBV and Syphilis test data for all donated blood specimens have been harmonized, and donor blood samples with key serological results have been shared to establish a large TTIMS repository. The effort has provided insights into recent infections among blood donors using HIV LAg avidity or “recency” testing; the use of anti-retroviral therapy (ARV) by HIV+ donors; use of pre-exposure prophylaxis (PrEP) by HIV seronegative donors presumed to be at high risk of infection, and HIV molecular epidemiology among blood donors.

Initially TTIMS was conducted through two separate complimentary contracts consisting of a Donation Database Coordinating Center (DDCC), which managed an integrated donation database, and a Laboratory and Risk Factor Coordinating Center (LRCC), which maintained a specimen repository, provided more advanced laboratory testing of blood samples and conducted risk interview assessments of HIV-positive or at risk donors. This SOW solicits a combined scope of TTIMS work previously conducted by DDCC and LRCC. The continued TTIMS effort will require close coordination among participating organizations to ensure timely transfer of confidential data among the organizations and ensure integration of activities to achieve the overall aims of the TTIMS program. Blood collection organizations participating in TTIMS shall agree to participate in all TTIMS data collection efforts. In particular, blood collection organizations must share relevant donor data including donor characteristics, risk factors and testing on HIV, HCV, HBV and syphilis positive blood donors, as well as other relevant and potentially emerging TTIs.

1.2 TTIMS Governance Framework

Oversight and governance of TTIMS will be provided by the US FDA Contracting Officer’s Representative (COR) within the CBER Office of Biostatistics and Pharmacovigilance. The Contractor shall establish the TTIMS Steering/Monitoring Committee (“Committee”) within 30 calendar days of contract award, to work with FDA and other DHHS representatives. Data analyses and reports provided by the contractor will be reviewed by the COR and Committee members comprised of the Principal Investigator (PI), and Co-PIs representing participating blood center organizations, TTIMS personnel, and experts from stakeholder DHHS Agencies, including FDA, NIH/NHLBI and others.

The Committee shall meet no less than once every month by teleconference and in person at least once a year. Unforeseen circumstances may arise requiring additional communication which would likely be made via teleconference.

If necessary, smaller subcommittees will be formed to address specific issues. The Contractor shall report back with findings and recommendations for discussion and any necessary action by the Committee/subcommittees. The Government officials on the Committee (FDA and NHLBI) will provide necessary information to the appropriate stakeholder Federal Agencies. The Contractor shall receive feedback on the reports they generate, as well as notice of any weaknesses, and recommended changes.

2. Objectives

The purpose of TTIMS is to maintain and enhance as needed an integrated, comprehensive US blood donor surveillance system, composed of a representative sample of the US blood supply, to monitor TTIs such as HIV, HBV, HCV and syphilis. The data aim to provide information about the current and evolving risks to the United States blood supply. TTIMS will characterize TTI marker risks in the US blood supply, including temporal, geographic, and demographic trends of the risks, and monitor changes in TTI risks and blood donor risk factors over time, in particular, after donor eligibility policy changes.

TTIMS fills a significant gap in public health blood donor surveillance and serves as a resource for additional investigations related to blood safety. Specifically, the primary objective of this contract is to build upon existing the TTIMS system to:

a. Establish and maintain an allogeneic blood donation test result and demographic database, with a representative sample (>60%) of the U.S. mainland allogeneic volunteer blood collections;

b. Monitor and characterize relevant transfusion-transmissible infections (RTTIs) and potentially emerging TTIs identified at participating blood collection organizations and assess their prevalence and incidence rates among US blood donors, overall and by demographic and geographic subgroups;

c. Evaluate temporal, demographic, and geographic trends in incidence and prevalence rates for relevant transfusion-transmissible infections over the periods of interest;

d. Evaluate and monitor risk factor characteristics of donors whose donations are confirmed positive for HIV, HBV, HCV, syphilis, and other markers determined to be of interest;

e. Evaluate and monitor risk factor characteristics of donors whose infections are recently acquired;

f. Compile and link bio-specimens in repositories with donation datasets from TTI-positive donors;

g. Report complete lookback data for HIV and HCV (number of recipients transfused with prior donations by HIV- or HCV- currently positive donors, status of recipients).

h. Provide biostatistical and analytical expertise and serve as laboratory testing center relevant to the evaluation and monitoring of HIV, HCV, HBV consensus positive blood donors and for syphilis positive blood donors;

i. Provide logistical support for the TTIMS project and for the Committee/Subcommittee meetings, conferences, and sample transfer/shipment.

3. Task Description(s)

The following tasks constitute the performance work expectations for TTIMS.

3.1 – Data Collection and Data Management The Contractor shall identify, recruit, and manage TTIMS blood center participants in sufficient volume to establish an allogeneic blood donation test result and demographic database representing 60% or more of the U.S. mainland allogeneic volunteer blood collections within 30 calendar days of contract award. The Contractor shall provide a Blood Donor Center Enrollee Report and de-identified data to the FDA COR.

Furthermore, the Contractor shall lead the donation database effort including the identification and evaluation of HIV, hepatitis and syphilis-infected blood donors. The Contractor shall provide a Blood Donor Center Enrollee Report and de-identified data to the FDA COR.

The Contractor shall develop and implement secure and robust data collection, tracking, management, and storage for TTI test results, demographic, first-time/repeat status, and other blood donor/donation data from participating blood collection centers.

The Contractor shall provide all necessary and relevant data management and tracking procedures, and tools to the participating blood collection organizations.

The Contractor shall perform the following activities, as directed by the Executive Committee:

a. Collect blood donor datasets and corresponding donor demographic data as required to achieve overall program objectives (i.e. 60% or more of US blood donors).

b. Provide screening and supplemental/confirmatory test results for relevant transfusion transmissible infections among all allogeneic blood donations collected.

c. Work collaboratively with the Committee to develop and finalize both the overall TTIMS project protocol within two months of contract award and a Manual of Operations (MOP) within three months of contract award by providing technical expertise in the areas of blood banking and transfusion medicine, infectious disease, databases/datasets management, study design and analytical/bio-statistical approaches including incidence and prevalence estimation.

i. The MOP shall describe in detail procedures, deliverables, milestones, timeline of performance for the TTIMS project and shall be approved by the COR prior to implementation. At a minimum, the overall MOP shall address governance; coordination;

communication; procedures for identification of TTI-positive donors; survey development and administration; laboratory procedures; bio-specimen collection, shipping, and storage; data collection, management/tracking, consensus definitions, security, transfer and sharing considerations; TTI risk and risk factor monitoring and associated trigger thresholds and resulting investigation procedures; training and site visit procedures; statistical and analytical plans for all data reports, and analyses; presentations, reports, and publications policy; human subject considerations; and processes to obtain all necessary administrative/regulatory clearances including applicable Institutional Review Boards (IRBs), and Office of Management and Budget (OMB), as appropriate.

d. Assign a unique Identification (ID) number for each test positive donor, allowing the donor to be followed longitudinally and individual donations and components identified;

e. Securely handle, store and maintain the link between the unique study donor ID and the donor identification information to allow appropriate donor follow-up when needed;

Coordinate, identify, enroll, and characterize HIV, HBV, HCV, and syphilis positive blood donors by participating blood collection organization(s);

f. Integrate risk factor data and disease marker surveillance information across different blood collection organizations using donation/donor data information;

g. Report complete lookback data for HIV and HCV (number of recipients transfused with prior donations by HIV- or HCV- currently positive donors, status of recipients).

h. Manage the datasets (in formats and according to timeframes delineated in the MOP) to include at a minimum the following data and activities:

i. Screening and supplemental/confirmatory test results for RTTIs on all allogeneic blood donations collected, as well as corresponding donor demographic data. Donor/donation data shall be as comprehensive as possible to achieve overall program objectives;

ii. Data relevant to evaluation of risk factors in TTI-positive donors per specified format, including coordinating follow-up evaluations;

iii. Assigning and securely storing a unique Identification (ID) number for each test positive donor, allowing donors to be followed longitudinally;

iv. Coordinate any needed data transfers among participating centers and linkages between datasets;

v. Collect and manage all data relevant to the evaluation of risk factors in TTI-positive donors as well as follow-up evaluations.

Table 1 Task 3.1 Deliverables

3.2 - Maintain Bio-specimen repository and Conduct laboratory testing

The Contractor shall perform the following duties related to maintaining blood donation specimens:

a. Coordinate with participating blood collection organizations regarding collecting, tracking, shipping (including freight), storage, and retrieval of all biospecimens necessary for lab characterizations;

b. Closely collaborate/coordinate to ensure linkages between donation data and specimens;

c. Collect and ship bio-specimens to the repository and coordinate to manage all data relevant to the evaluation of risk factors in TTI-positive donors as well as follow-up evaluations;

d. Perform validated “recency” testing of HIV antibody positive donations to distinguish more recently acquired from longer-standing HIV infections, and improve classification of HIV incidence and

Task Deliverable/Work Product Title

Due Date Quantity / Frequency

Delivered To

3.1 Blood Donor Center Enrollee

Report

Quarterly Ongoing COR

3.1 Donation Database Protocol 2 months after Contract

Award

Ongoing COR

3.1 Manual of Procedures (MOP) 3 months after Contract

Award

Once COR provide data quarterly to allow optimal classification of HIV-positive donors as incident or prevalent cases.

Table 2 Task 3.2 Deliverables

3.3 – Infection Marker Incidence and Prevalence Among Donors, and Residual Risks of TTIs

The Contractor shall complete and report TTI analyses:

a. Calculate blood donor marker prevalence and incidence with 95% Confidence Interval (CI) for HIV, HBV, HCV, syphilis, and other RTTIs. HIV incidence estimates shall be determined based on window period (inter-donation interval model for seroconverting repeat donors), validated HIV Nucleic Acid Test (NAT) only, and HIV "recency" testing;

b. Provide TTI prevalence and incidence estimates (when available) with 95% CI; stratified by demographic, first-time/repeat status, geographic, and temporal variables;

c. Provide estimates of residual risk (and 95% CI) for HIV, HBV, HCV, syphilis, and other RTTIs for the US blood supply on an annual basis;

d. Provide well-characterized TTI donor/donation data for analysis of TTI donor data stratified by donor risk factors;

e. Contribute study hypotheses and new study protocols as appropriate;

f. Evaluate and monitor trends in incidence and TTI-positive donor characteristics (demographic, geographic, temporal, and risk factors) in accordance with procedures delineated in the MOP;

g. Evaluate and monitor risk factor characteristics of donations confirmed positive for HIV, HBV, HCV, or syphilis at participating blood collection organization(s);

h. Coordinate with participating blood collection organizations to conduct follow-up investigations triggered by significant changes in TTI incidence/prevalence rates, specific risk factors or certain high-risk groups;

i. Establish procedures and processes to ensure that participating blood collection organizations perform all follow-up investigations triggered by significant changes in transfusion-transmissible viral infection incidence, prevalence, rates, and risk factors.

j. Develop an Analytical Plan detailing the methodology for risk factor analyses, and pertinent demographic, geographical and temporal trend analyses. Specifically, the plan shall:

Include a description of significant changes in transfusion-transmissible viral infection risk factors, which could potentially trigger in-depth evaluation of the determinants underlying these changes;

Task Deliverable/Work Product Title Due Date Quantity / Frequency

Delivered To

3.2 1. Infected Blood Donor Datasets In accordance with

MOP

Ongoing In accordanc e with

MOP

3.2 2. Data transfers between different organizations, as required

In accordance with

MOP

Ongoing In accordanc e with

MOP

3.2 3. Bio-specimen shipments between organizations, as required

In accordance with

MOP

Ongoing In accordanc e with

MOP

k. Identify routinely produced data reports to be provided for Committee evaluation.

l. Prepare and submit recurring technical progress reports containing descriptive information about the activities undertaken during the reporting period and information about planned activities for future reporting periods. The submission frequency is expected to be on a semi-annual basis, but is subject to change as trends develop;

m. Prepare and submit a semi-annual progress report. It shall be in letter form (minimum 2-3 pages) and include progress for the reporting period, problems encountered, goals met or missed, a summary of activities planned for the reporting period, and reports / abstracts / presentations / manuscripts in progress, submitted or published;

n. Provide corresponding donation denominator data including total number of donations collected per month by each blood collection organization broken down by the type of donation (if other than allogeneic donation data are collected), the procedure (apheresis platelet, whole blood, RBC apheresis, etc.), age, gender, race and geographic indicator;

o. Prepare an Annual Technical Report summarizing all work results performed. Specifically, the report shall include:

1. Cover page to include contract number, title, period of performance being reported, Contractor's name and address, telephone and facsimile numbers, and date of submission;

2. An executive summary, to include:

o A statement of intended work for the reporting period;

o A brief overview of the work that was completed for the reporting period; any problems

(technical or financial) that occurred and their resolution or status;

o Advancements made in relation to any of the technical tasks set forth in the Statement of

Work (SOW);

o A full description of data pertaining to, work performed during the reporting period, materials and methods pertaining to the work, relationship between the accomplishments made relative to goals and tasks of the Statement of Work, problems encountered and resolution. If applicable, full disclosure of any efforts to transfer the technology or receipt of support from outside entities interested in future access, partnering, or license to the developing technologies.

p. Prepare a Final Technical Report consisting of a description of work performed and results obtained for the entire contract period of performance in sufficient detail to describe comprehensively the results achieved;

q. Prepare published or unpublished abstracts, presentations, reports, and manuscripts derived from analyses under the contract.

Table 3 - Task 3.3 Deliverables

Task Deliverable/Work Product Title Due Date Quantity / Frequency

Delivere d To

3.3 TTI data reports and analysis results

(prevalence and incidence estimates, independent hypotheses, residual risk, etc.)

In accordance with the

MOP

Quarterly (minimum)

COR

3.3 List of all HIV, HBV, HCV, Syphilis, and other marker positive donations

10th calendar day of the month (for prior month’s report)

Monthly (include in Status Report)

COR

The Contractor shall explore the following optional tasks relevant to the overall scope of work. Optional tasks may be funded depending on funds availability and discretion of the FDA:

1. Evaluate impact of Individual Donor Assessment on donor deferrals and TTI rates and residual risk, including assessment of non-disclosure rates and effectiveness of the donor health questionnaire in the era of individual donor assessment.

2. Monitor ARV and PrEP/PEP use in US allogeneic blood donor population, including assessment of blood safety implications of HIV treatment and prevention therapeutics.

3. Development of additional biomarker-based tools for monitoring HIV, HBV and HCV infection incidence.

4. Development of strategies to assess the impact of emerging or re-emerging infectious threats to blood safety.

3.4 - Perform TTIMS Logistic Support

The Contractor shall schedule and provide administrative support for Committee and Subcommittee meetings. In performing this task the Contractor shall:

a. Prepare and distribute agendas to include conference call-in information

b. Prepare and distribute review materials

c. Take and distribute minutes and action items to meeting participants

d. Track and maintain a central repository of minutes and action items and associated materials relating to all meetings/calls

e. Disseminate scientific reports at scientific venues and to relevant FDA or HHS advisory committees.

3.3 Donation Denominator Data 10th calendar day of the

month (for prior month’s report)

Monthly (include in Status Report)

COR

3.3 Technical Progress Reports At intervals, as specified by

the COR and/or MOP

Minimum Quarterly

COR

3.3 Semiannual Technical Reports Within 15 calendar days

before the end of the reporting period.

Two per year COR

3.3 Draft Annual Technical Reports Draft due 30 calendar days before the end of the reporting period.

Annually COR

3.3 Final Annual Technical Reports Final due at the end of

reporting period

Annually COR

3.3 Draft Final Technical Report Draft due 30 calendar days

before the last day of the contract’s period of performance

One COR

3.3 Final Technical Report Final due at the end of

contract’s period of performance

One COR

3.3 Manuscripts for publication 30 calendar days prior to

the agreed date

Anticipate one per year

COR

f. Prepare a Draft Technical Report and a Final Technical Report consisting of a description of work performed and results obtained for the entire contract period of performance in sufficient detail to describe comprehensively the results achieved.

g. Prepare abstracts, presentations, reports, and manuscripts for publication derived from analyses under the contract.

Table 4 - Task 3.4 Deliverables

3.5 – Project Management, Communication and Outreach

The Contractor shall plan and implement TTIMS initiatives that are reviewed and approved by the TTIMS Executive Committee. For all aspects of blood safety research and surveillance anticipated or conducted by the contractor during the period of TTIMS funding, the proprietary interests of the TTIMS program shall be respected and any new data, hypotheses, study initiatives and analysis plans relevant to blood safety in the US shall be reviewed by the TTIMS Executive Committee for possible inclusion in the overall TTIMS program. This requirement shall also apply to TTIMS-funded sub-contractors.

The Contractor shall act as a member of the TTIMS Committee and any assigned subcommittees. The Contractor shall establish and serve on a TTIMS Steering/Monitoring Committee (Committee) within 30 calendar days of contract award. The committee should include FDA NHLBI, and any other DHHS

Task Deliverable/Work Product Title Due Date Quantity /

Frequency Delivered To

Task 3.4

Committee/Subcommitte e Conference Calls, Meeting Minutes

By 10th calendar day following the meeting Monthly COR, Committee

Task 3.4

Committee/Subcommitte e Agendas

5 calendar days prior to the meeting Monthly COR, Committee

Task 3.4

Central Electronic Repository of Meeting Minutes/ Calls/Action Items

Last business day of the month Ongoing

COR,

Committee, FDA TTIMS

CGE

Task

3.4 Draft Technical Report

Draft due 30 calendar days before the last day of the contract’s period of performance

One COR

Task

3.4 Final Technical Report Final due at the end of contract’s period of performance One COR

Task 3.4

Abstracts and Presentations

10 business days prior to submission or presentation

Anticipate at least one per year

COR

Task

3.4 Reports and Manuscripts

30 calendar days prior to the agreed date

Anticipate one per year

COR

Task 3.4

Upload SOPs, study protocols, IRB approvals, technical reports, meeting minutes, abstracts, slide presentations and publication

Within 10 business day after the documents are generated/received As needed FDA TTIMS

CGE

interested parties (including statisticians), and donor organizations. The Contractor’s Principal Investigator (PI) shall attend all Committee and subcommittee conference calls, at least once per month for the duration of the contract period of performance. The Contractor shall coordinate, schedule, and provide logistical support for Committee/Subcommittee meetings / conference calls. The contractor shall provide regular updates on the work being accomplished to the Committee and other identified stakeholders. The Contractor shall be responsible for leading discussions, participating in discussions, contributing questions and answers; raising and addressing issues, risks and concerns; developing and giving presentations, and other active oral and written communications. The Contractor shall prepare meeting agendas, minutes, and action items and circulate to the Committee in a timely manner. The Contractor should submit TTIMS documents including SOP, MOP, study proposals, IRB approvals, meeting minutes, monthly and annual reports, conference presentations (slides of posters) and manuscripts in time to FDA TTIMS CGE.

3.5.1 Project Meetings and Status Reporting

The Contractor shall provide project/contract management to ensure that contracted tasks stay on track and milestones, performance measures, deliverables and work products are met.

The Contractor shall participate in a kickoff meeting within 10 calendar days of contract award. The purpose of the kickoff meeting is to introduce the contractor staff to the Government and discuss the contractor’s approach to meeting the requirements of the SOW.

The Contractor shall deliver a Monthly Status Report (MSR) to the COR on the 10th business day of each month following the end of the previous calendar month. At a minimum the MSR shall contain the following information:

a. An overview of work completed, in progress, and planned for next month on each task;

b. Identification of challenges, issues, and risks with recommended remedial actions;

Lastly, the Contractor shall ensure that all deliverables are sent in electronic formats (i.e. Microsoft Office or Adobe PDF) for the COR’s inspection/acceptance and posted on the TTIMS CGE.

The Contractor’s Principal Investigator (PI) shall attend face-to-face annual Committee meetings located at Silver Spring, Maryland (1-day duration) as scheduled.

Table 5 - Task 3.5.1 Meetings Deliverables

Task Meeting / Activity Title Location(s) / Due Dates

Estimated Occurrences

Receiving Organization

Task 3.5.1 Contract Kick-Off Meeting & Minutes

Teleconference within 10 calendar days of contract award

One COR

Task 3.5.1 Steering Committee conference call

Teleconference No less than once monthly

Committee

Task 3.5.1 On-Site Meeting (to include PIs and some Committee Members)

FDA White Oak Campus, Bldg 71 (in-person meeting only) or other locations to be specified

Annually

Committee

3.5.2 Site Visits

The Contractor shall work collaboratively with the COR to assess, recommend, and document the practices, training needs, provide training as applicable, and conduct a minimum of two (2) site visits to address and remedy issues encountered with each participating blood collection organization in the conduct of TTIMS activities related to the evaluation of the HIV, HCV, HBV, and syphilis positive donors.

The Contractor shall develop a donor site visit schedule and training materials that will ensure quality and consistency of the collective data and reports.

3.5.3 External Collaborations

The Contractor will collaborate with other Government Agencies and/or other individual blood organizations. All external collaborations and investigations should be approved by the CBER COR and/or TTIMS Executive Committee. All external collaboration requests shall be sent via written communication (e.g. email) according to the defined process. The purpose of these collaborations will be to use existing TTIMS data or resources to address additional research questions.

Table 6 Tasks 3.5.2 & 3.5.3 Site Visit & Collaboration Deliverables

Task Deliverable / Work Product Title Due Date Quantity /

Frequency Delivered To

Task 3.5.2

Blood donor center site visit schedule

30 calendar days after contract award

2 per years for 1st year enrollment COR

Task 3.5.2

Written Site Visit Report

30 calendar days after each site visit

Minimum of two yearly over the contract period

COR,

Committee

Task 3.5.3

Written External Collaboration Requests

Within 30 days of receipt As needed COR, Committee Task 3.5.3

TTIMS documents (as described above) On-going As needed FDA TTIMS

CGE

3.5.4 Facilities

The Contractor shall provide facilities and equipment (i.e. BSL-3 facility) as needed to follow appropriate biohazard containment procedures, in order to accomplish the requirements as specified in task areas 3.1 through 3.4. Additionally, the Contractor shall provide the capacities to store biological/infectious materials and specimens at -70°C (minus 70 degrees Celsius).

The Contractor shall ensure that donor demographic data are captured, retained and protected for future study purposes.

3.5.5 Quality Control

The Contractor shall deliver high-quality data and information obtained following FDA Statute, Guidance

Task 3.5.1 Steering Sub-Committee Conference Call

Teleconference As needed Committee

Task 3.5.1 Monthly Status Report 10th business day of the month

Monthly COR and Good Manufacturing Processes (GMPs), required of all licensed blood collection organizations operating within the United States and high-quality written materials (technical documents, analyses, reports, etc.). See Appendix A, Quality Assurance Surveillance Plan (QASP) for performance standard matrix.

The Contractor shall provide comprehensive, clear analysis of trends and their effects in order to provide strategic profiles and advice to senior management on suitable policies and the effects of policy decisions and new regulations.

a. Information shall reflect state-of-the-industry practices and current applicable regulatory requirements;

b. The Contractor shall take the lead in developing documents and shall incorporate a high level of quality assurance and responsiveness;

c. The Contractor shall not receive more than two customer complaints regarding documents prepared within any twelve-month period of performance;

d. Reports and technical documents shall be delivered within the timeframe specified with minimal errors and need for corrections;

e. The Contract shall ensure the following:

• That its staff have the requisite subject matter expertise and skill sets;

• 100% of Key Personnel shall be on-boarded within 30-calendar days of award.

In addition, the Contractor shall be proactive in informing the designated CBER COR of any issues, problems and recommendations to ensure accomplishment of contract goals and deliverables.

Recommendations for actions that need to be taken by FDA staff, or other Contractors shall be clearly defined and communicated to the responsible party and the FDA and have identified dates for completion.

3.5.6 Transition Out

A smooth and orderly transition-out between the incumbent Contractor and the successor Contractor or Government is necessary to ensure minimum disruption to vital FDA business. The Contractor shall submit and execute a Transition-Out plan to ensure business continuity for the FDA in the event that a new Contractor is selected. At a minimum, this Transition-Out plan will include the following:

a. Transition-Out Plan and Schedule;

b. Inventory of documentation to be turned over;

c. Submission of knowledge transfer documentation to include current and up-to-date Standard

Operating Procedures (SOPs);

d. Participate in all Transition-In activities with successor Contractor;

e. Provide “shadowing” and participate in knowledge transfer meetings and opportunities to facilitate the transfer of information, processes, and data needed to continue the services being performed by the Contractor;

f. Identify, track and discuss with the Government any known problems, risks or issues associated with the transition

Table 7 Task 3.5.6 Transition Out Deliverables

4. Contract Constraints

The following constraints are applicable to this contract:

a. The Contractor shall ensure that all appropriate administrative and regulatory approvals are obtained as described in the MOP by any participating blood collection organizations before TTIMS data collection begins. These include but are not limited to those that address human subject considerations and clearances including applicable Institutional Review Boards (IRBs), and Office of Management and Budget (OMB).

b. The identity of the blood donor shall not be provided to the Committee.

c. Interim data used in technical progress reports and other reports developed for the purpose of study monitoring, or internal collaborations shall not be released publicly. Premature release of such data could result in interpretations that prove to be unreliable or invalid once the study is completed and the full context for the data is known and lead the public and medical practitioners to pursue inappropriate measures.

d. Legend for Technical Progress Reports Containing Interim Study Data:

i. The Contractor shall incorporate the following legend on the cover page of technical progress reports and reports containing interim study data that are prepared for internal and confidential use by the Committee or other Committees such as the Blood Product Advisory Committee or the Advisory Committee on Blood & Tissue Safety & Availability:

"The data, if any, contained in this report/deliverable are preliminary and may contain un-validated findings. These data are not intended for public use. Public use of these data could create erroneous conclusions which, if acted upon, could threaten public health or safety."

e. Manuscripts/reports in progress and proposed for publication shall follow TTIMS procedures outlined in the Presentation/Publication MOP and are to be provided to the COR for review and comment at least 30 calendar days prior to submission for publication.

f. Abstracts and presentations shall follow TTIMS procedures outlined in the Presentation/ Publication MOP and are to be provided to the FDA COR for review and comment at least 5 calendar days before submission or presentation, respectively.

g. The computer programs, data management systems, databases, and other resources developed through this contract shall comply with data standards and procedures established by DHHS and FDA (per http://www.fda.gov/ForIndustry/DataStandards/default.htm).

h. Blood collection organizations will collect, process, and store bio-specimens until shipments are coordinated.

i. The Contractor shall provide the necessary freezers, containers, and other supplies to the participating blood collection organizations to properly and safely transfer the bio-specimens.

Task Deliverable/Work Product Title Due Date Quantity / Frequency

Delivered To

3.5.6 Transition Out Plan 30 calendar days prior to the

end of the contract

One COR http://www.fda.gov/ForIndustry/DataStandards/default.htm

j. The Contractor will provide a unique identification number (ID) for each donor allowing donors to be longitudinally followed and individual donations and components identified in the databases.

These unique identifiers will accompany the data files.

i. The identity of the blood donors will be known only to the blood center investigator(s) and will not be shared. Participating blood collection organization shall maintain the link between the unique study donor ID and the donor identification information to allow the center to contact the donor for appropriate follow-up.

ii. The link between study donor ID and donor name or other identifiers shall be kept in a secured location at the participating blood centers.

5. Schedule of Supplies/Services and Price/Cost

Contract

Line Item

(CLIN)

Description QTY Unit Unit Price Extended Price

1 TTIMS duties to be performed including all labor, facilities, materials and travel in accordance with requirements as identified in SOW and Section 3 (“Task Description(s)”) Base Year Period of Performance

(POP) 09/25/2025 – 9/24/2026

1 YR

The below items are optional and may be exercised in accordance with the applicable FAR Clause 52.217-9.

Option Item (FAR 52.217-9) Contract Line Item

(CLIN)

Description Est

QTY

Unit Unit Price Extended Price

2 Option Year 1 - Same as Item 1 description.

POP 09/25/2026 – 9/24/2027

1 YR

3 Option Year 2 - Same as Item 1 description.

POP 09/25/2027 – 09/24/2028

1 YR

4 Option Year 3 - Same as Item 1 description.

POP 09/25/2028 – 9/24/2029

1 YR

6. Period Of Performance

The anticipated performance periods for the base contract plus three (3) one-year option years are as follows:

Base Year: 09/25/2025 – 9/24/2026 Option Year 1: 09/25/2026 – 9/24/2027 Option Year 2: 09/25/2027 – 9/24/2028 Option Year 3: 09/25/2028 – 9/24/2029

7. Place Of Performance

Work will be performed at the contractor’s location but will support the FDA’s Center for Biologics, Evaluation and Research (CBER) located at:

US FDA/CBER

10903 New Hampshire Ave.

Silver Spring MD 20993

8. Observance of Federal Holidays & Other Government Closings

No services or deliveries shall be performed at federal sites on federal legal holidays or during other federal closures as determined by Executive Orders or opm.gov. Federal Holidays are as follows:

New Year’s Day Labor Day Martin Luther King, Jr.’s Birthday Columbus Day Washington’s Birthday Veterans Day Memorial Day Juneteenth Thanksgiving Day Independence Day Christmas Day

9. Inspection and Acceptance

Services and/or supplies delivered hereunder shall be inspected and accepted at destination by the Contracting Officer’s Representative (COR) specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the Contracting Officer.

10. Service Contract Labor Statutes

Unless determined otherwise, work performed under a contract resulting from this solicitation is subject to the Service Contract Labor Standards statute; however, the place of performance is not yet known. Wage Determination(s) will be incorporated into any resultant contract as a separate attachment.

10.1 Wage Determinations

Offerors shall provide wage determination numbers for all locations of work to be performed by any non-exempt SCA employees. Offeror shall provide any Collective Bargaining Agreements in place, if applicable. Wage Determinations will be attached and incorporated into any resultant contract awarded from this solicitation.

11. Instructions to Offerors

Please review the attached Statement of Work (SOW) and submit quotes in accordance with the below instructions via email to the contract specialist, Nam Nguyen, at nam.nguyen@fda.hhs.gov by 9:00 am EST on August 22, 2025. Please use the following on the subject line for your submission: 75F40125Q00337 – TTIMS Submission. Any late submissions will not be accepted.

Please submit any questions/clarifications regarding this requirement via email to the contract specialist, Nam Nguyen, at nam.nguyen@fda.hhs.gov by 9:00 am EST on August 11, 2025. Please use the following on the subject line for your questions: 75F40125Q00337

– TTIMS Questions. Any late questions will not be accepted.

It is anticipated that this will be a Firm Fixed Price contract type.

The offeror will include the following information in their submission:

o The solicitation number and title;

o The date and time specified in the solicitation for receipt of offers;

o Tax identification number (TIN);

o Unique Entity ID no.

o Contact Name o Contact Email Address

Offerors shall submit all electronic documents for Microsoft Office suite products without the use of “macros”. If the offeror submits documents that contain macros the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No additional time will be given to an offeror or applicant to correct the document submission, and the Government will not inform the offeror or applicant that their submission is non-responsive prior to award. It is the offeror’s or applicant’s responsibility to ensure that all electronic documents submitted do not contain or otherwise use macros.

General Information

Proposal Volumes. Offerors’ proposals shall consist of three separate Volumes (see format instructions below):

• Volume 1 – Technical Proposal

• Volume 2 – Past Performance

• Volume 3 – Business/Pricing

The Government will evaluate proposals in accordance with the technical evaluation factors as described in the section titled, Evaluation Criteria & Basis of Award.

Volume Preparation Instructions (Format)

Each volume shall be complete and separate from other volumes, signed by an official authorized to bind the Offeror. To permit a thorough and effective evaluation, each volume should be precise and complete, while as brief as possible. It is essential that the Offeror present information in sufficient detail so as to permit the Government to make an evaluation without further information being required from the Offeror.

All Volumes shall be formatted for standard letter-size (8.5 x 11 inch) paper with standard one-inch margins on each border, single spaced using a minimum of 11-point body text font size (table and graph font may be smaller, but must be clearly legible), using Times New Roman font.

All Volumes shall include:

• Cover Page (include the RFP title, RFP number and Company name)

• Table of Contents.

Electronic copies shall be submitted as follows:

• Using Microsoft Office programs (Word, Excel). If using Excel, do not hide formulas and do not protect cells.

• Adobe PDF:

o Combine individual files (if applicable) into a single PDF per Volume, i.e.

Volume 1 – Technical Capability shall be submitted with the original Word documents and also with all Word files consolidated (if applicable) into a single pdf file. Submit Volume 2 and 3 in the same manner.

o PDF must be unlocked, unprotected, and fully searchable for specific text (i.e. not a scanned document with non-renderable text that will not allow word search functions).

Proposal Instructions (Content)

Volume 1 – Technical Volume. Factor 1: Technical Capability

The Technical Proposal shall not contain any reference to cost or price.

The Technical Proposal shall not exceed 25 pages. The Cover Page and Table of Contents are not included in the page limit.

Offerors must provide a narrative description which is aligned to the Statement of Work (SOW), Task Descriptions, and include sufficient technical information necessary for the Government to conclusively determine that the offered services meet or exceed each of the requirements identified therein. Proposals shall thoroughly address at a minimum, the technical approach, program/project management, resources (i.e., facilities, hubs, staff, subcontractors, etc.), quality control, communications and outreach that will be utilized to satisfy all of the SOW requirements; detail; how the approach will further ensure the overall program objective(s) will be achieved. Identify personnel key to the success of the proposed approach, which at a minimum shall include program/project manager(s) and principal investigators/co-principal investigators, discuss their roles and responsibilities as well as their experience in performing same or near-same services. The Offeror shall demonstrate their understanding of the requirements as set forth in the SOW and the Offeror’s methods, procedures and approach to performing the work.

Volume 2. Factor 2: Past Performance

The purpose of this Past Performance section is for the Offeror to demonstrate/discuss how well the Offeror performed and how well the offered services met the requirement on similar contracts/projects; therefore, the Offeror shall submit recent and relevant past performance information on currently ongoing or completed contracts within the last three (3) years. A Past Performance Evaluation Questionnaire is provided for you to send to each of your clients notifying them that you have identified them as a reference related to past performance and notifies them that the questionnaires be returned to Nam Nguyen at nam.nguyen@fda.hhs.gov.

Offerors shall include a copy of the completed Past Performance Evaluation Questionnaire sent to each of the Clients with their proposal. Offerors are responsible for completing the “Contract Identification” information in Paragraph 1 of the Past Performance Questionnaire before sending the client letter and questionnaire to the client for their completion. If an Offeror has records in CPARS, CPARS may be submitted in lieu of the Past Performance Evaluation Questionnaire (PPEQ); however, Offerors must fill out Section 1 of the PPEQ and submit that with the Proposal.

Contracts listed may include those entered into by the Federal Government, agencies of state and local governments and commercial customers. Recent is defined as within the last three (3) years.

Relevant is defined as work similar in terms of type, scope, complexity, and size of the work described in the SOW.

Past Performance information will be used to determine the likelihood of success in meeting the FDA’s requirements as indicated by the Offeror’s record of past performance.

Volume 3. Factor 3: Business/Pricing

The price proposal shall consist of the following elements:

a. Offerors shall provide an in-depth cost proposal, in excel format as well as a pdf version, which shall include: proposed labor categories with number of FTEs proposed, labor category descriptions, fixed or estimated labor hours, fully-burdened hourly rates and a breakdown of the price build-up for those rates. Fully burdened hourly rates for each labor category shall include wages, indirect costs, fringe benefits, overhead, general and administrative and profit, as well as any proposed management fees and a list of and proposed costs for equipment and materials. Offerors may use any spreadsheet format that provides the rate build-up for the Base Year and each Option Year.

b. Your proposal must stipulate that it is predicated upon all the terms and conditions of this solicitation. In addition, it must contain a statement to the effect that pricing is valid through September 30, 2025.

c. A statement acknowledging any formal Amendments issued to the solicitation.

d. A narrative detailing any assumptions not addressed elsewhere in the proposal.

e. A completed copy of the provision at 52.212-3, Offeror Representations and Certifications—Commercial Items.

f. Any other completed provisions with required fill-in information presented in the list mailto:nam.nguyen@fda.hhs.gov of provisions and clauses herein.

Small Business Subcontracting Plan – Integral to any award decision and pursuant to FAR Clause 52.219-9, and as otherwise set forth herein, the Offeror shall submit with its proposal, a small business subcontracting plan containing at a minimum the content required by FAR Clause 52.219(d) and using the HHS Small Business Subcontracting Plan template attached to this solicitation. If the Offeror determines that there will not be subcontracting opportunities, the Offeror shall still submit a subcontracting plan and include a statement of circumstances supporting this determination. Failure to submit and then negotiate an acceptable subcontracting plan within 10 calendar days of the date the Contracting Officer notifies the offeror of issues and concerns with the subcontracting plan will render the offeror, notwithstanding any tradeoff decision above, ineligible for award. The resulting subcontracting plan will be made a part of the resulting contract and the Contractor shall comply with the reporting requirements of FAR Clause 52.219-9(I). Small businesses are exempt from this requirement.

The government is not responsible for locating or securing any information which is not identified in the proposal; however, the Government reserves the right to obtain information for use in the evaluation from all sources including sources outside of the Government.

It is the offeror's responsibility to monitor the Government Point of Entry (GPE) beta.sam.gov, Contract Opportunities for information relevant to this solicitation, e.g., questions and answers, amendments, etc. An official authorized to bind the Offeror must sign the terms and conditions of the offer. Offerors that fail to complete the required representations and certifications or reject the terms and conditions of the solicitation may be excluded from consideration.

Proprietary and/or confidential information shall be clearly marked.

EVALUATION CRITERIA & BASIS OF AWARD

The Government will award a contract resulting from this solicitation to the responsible Offeror whose offer conforming to the solicitation will be the most advantageous to the Government, price and other factors considered.