TTIMS LRCC SOW 7-28-21.pdf

Transfusion-Transmissible Infections (TTI) Monitoring System (TTIMS)

Laboratory & Risk Factor Database Coordinating Center (LRCC)

ATTACHMENT 1:

Statement of Work (SOW)

Table of Contents

1. Introduction

1.1 Background

1.2 TTIMS Governance Framework

1.3 TTIMS LRCC Objective

2. Task Description(s)

2.1. Task 1: Establish TTIMS LRCC Protocols, Procedures, and Repository

2.2. Task 2: Coordinate Identification, Characterization & Monitoring of high-risk blood donors ( such as PrEP/PEP/ARV users) and TTI-Positive (e.g. HIV, HCV, and HBV) Blood Donations

2.3. Task 3: Perform Laboratory Testing, Data Collection and Management Pertinent to

Characterization of TTI-Positive Donors and Those Identified as Using ARV/PrEP/PEP or Other Markers of High Risk Behavior

2.4. Task 4: Perform TTIMS Logistic Support

2.5. Task 5: Communication and Outreach

2.5.1 Quality Control and Site Visits

2.5.2 External Collaborations

2.6. Task 6: Project/Contract Management

2.6.1 Facilities

2.6.2 Project Meetings and Status Reporting

2.6.3 Quality Control

2.6.4 Transition Out

3 Contract Constraints

1. INTRODUCTION

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.

During its July 2, 2013 meeting, the Department of Health and Human Services (DHHS) Blood, Organ, and Tissue Senior Executive Council (BOTSEC), which includes representation from Department of Health and Human Services, Office of the Assistant Secretary of Health (DHHS/OASH), Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), Centers for Medicare & Medicaid Services (CMS), Health Resources Services Administration (HRSA), Food and Drug Administration (FDA), HHS-Assistant Secretary for Planning and Evaluation (ASPE), HHS-Assistant Secretary for Preparedness and Response (ASPR), and Agency for Healthcare Research and Quality (AHRQ), unanimously voted to enhance monitoring of Transfusion-Transmissible Infections (TTIs) in the US.

The TTIMS will build on the NIH National Heart Lung Blood Institute’s REDS-II Transfusion-Transmitted Retrovirus Study (REDS) procedures established for centralization of proprietary blood center operational data, successful coordination of standardized data definitions, collection, analysis, and reporting of baseline epidemiologic and risk factor data for > 50 % of the United States (US) donor base.

At present, no single comprehensive blood donor or recipient surveillance system exists in the United States to monitor TTIs, such as Human Immunodeficiency Virus (HIV), Hepatitis B (HBV), and Hepatitis C (HCV) in such a large donor population. Subsequently, the external Federal DHHS Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) met in December 2013 and concurred with the BOTSEC and recommended that DHHS establish “an ongoing, integrated, coordinated, and nationally representative U.S. transfusion transmissible infections monitoring system.”

The FDA requires the establishment of a Transfusion-Transmissible Infection Monitoring System (TTIMS) through two separate complimentary contracts consisting of an integrated, comprehensive Donation Database Coordinating Center (DDCC) system and a Laboratory and Risk Factor Coordinating Center (LRCC), the subject of this statement of work, to provide in-depth laboratory assessment of donors who have confirmed markers for TTIs of interest. The TTMS DDCC contract was awarded last fiscal year (2020). The TTMS LRCC requirement needs to be awarded this fiscal year (2021).

The TTIMS program will build on the infrastructure and initial consensus infectious disease testing classification algorithms that were developed for the REDS-II Transfusion Transmitted Viral Infection (TTVI) Marker Prevalence and Risk Factor Study. The program will support the collection of integrated risk factor data and disease marker surveillance information across different blood collection organizations. Furthermore, systematically collected and combined data are critical for this national surveillance effort.

This effort requires close coordination between the DDCC and LRCC to ensure timely confidential data transfers and to achieve the aims of the TTIMS project. Blood collection organizations interested in participating in TTIMS will participate in both the LRCC and DDCC data collection efforts. In particular, blood collection organizations will share relevant donor data and blood specimens collected by their organization, with both Contractors for compilation and evaluation of TTI risks. The Contractor shall identify, survey, characterize, and provide risk factor and other data on HIV and incident HCV and HBV blood donors.

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 Epidemiology. The Contractor shall establish the TTIMS Steering/Monitoring Committee (aka the Committee) within 30 calendar days of contract award, to work with FDA and CDC representatives (including statisticians) to study historical trends. Data analyses and reports provided by the Contractor will be reviewed by the COR and Committee members comprised of the Principal Investigators (PI), and Co-PI representing participating blood center organizations, DDCC and LRCC personnel, and experts from stakeholder Department of Health and Human Services (DHHS) Agencies, including, FDA, NIH, and CDC.

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

If necessary, the COR will form smaller subcommittees and executive subcommittees to address issue specific priorities. 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 (NHLBI, FDA and CDC) will provide necessary information to the appropriate internal Federal Agencies. The Contractor shall receive feedback on the reports they generate, as well as any weaknesses and make recommended changes.

1.3 TTIMS LRCC OBJECTIVE

The TTIMS LRCC project purpose is to serve as the biostatistical and analytical center for all analyses relevant to the evaluation and monitoring of HIV (Incident and prevalent), HCV (incident) and HBV (incident) positive blood donors. Specifically the primary objectives of this Contract are to:

• Evaluate and monitor risk factor characteristics of donations confirmed positive for TTIs

• Compare/analyze risk factor data to that obtained in the REDS-II TTVI Marker Prevalence and

Risk Factor Study

• Integrate risk factor data and disease marker surveillance information across different blood collection organizations

• Monitor ARV and PrEP/PEP use in US allogeneic blood donor population based on testing of both HIV-positive and infection negative donations for the presence of ARV drugs.

• Explore the characteristics of blood donors who use ARV/PrEP/PEP to better understand their risks, knowledge, and motivations for donating while using these therapies.

• Evaluate well-characterized US blood donor samples form TTIMS and other sources for the refinement of existing analytical methods such as the Sedia LAg Avidity assay to derive estimates of recent infection with HIV with a goal of rapidly obtaining more accurate and timely results.

• Provide logistical support for the TTIMS project and for the Committee/Subcommittee meetings, conferences, and donation(s) transfer/shipment.

2. TASK DESCRIPTION(S)

The following tasks constitute the performance of work expectations for LRCC support.

2.1. TASK 1: ESTABLISH TTIMS LRCC PROTOCOLS, PROCEDURES, AND REPOSITORY

a. The Contractor shall work collaboratively with the Committee and the DDCC Contractor to develop and finalize the LRCC project protocols and the LRCC applicable sections of the TTIMS Manual of Operations (MOP). Procedures shall address at a minimum the following: laboratory procedures, ongoing bio-specimen collection and maintenance procedures for the repository, data collection, shipping and storage, management and tracking, consensus definitions, security, transfer, and sharing considerations.

b. The Contractor shall develop and implement secure and robust data collection, data quality control, tracking, management, and storage procedures for blood donor related data and bio-specimens relevant to the HIV and other blood-borne pathogens and substances of interest.

c. The Contractor shall create a centralized repository of samples from HIV-positive blood donations to serve future uses such as availability for HIV evolutionary geneticists investigating changes in HIV virulence and pathogenicity over time and shall be ready for investigation if an emerging agent of concern is identified or for virus discovery in general.

Table 1 Task 1 Deliverables/ Work Products

2.2. TASK 2: COORDINATE IDENTIFICATION, CHARACTERIZATION & MONITORING OF HIGH-RISK

BLOOD DONORS ( SUCH AS PREP/PEP/ARV USERS) AND TTI-POSITIVE (E.G. HIV, HCV, AND

HBV) BLOOD DONATIONS

The Contractor shall perform the following activities in support of Task 2:

a. Coordinate, identify, enroll, characterize, and monitor HIV (prevalent and incident), HBV (incident) and HCV (incident) positive blood donors by participating blood collection organization(s)

Task Deliverable/Work Product Title Due Date Quantity / Frequency

Delivered To

Task 1 1. LRCC TTIMS Protocols 2 months after Contract Award date Ongoing COR

Task 1

2. LRCC Sections/Input to the

Manual of Procedures (MOP) 3 months after Contract Award date Once COR

Task 1

3. Centralized Bio-Specimen

Repository 30 calendar days from contract award date

Ongoing (Updates)

COR,

Committee

Task 1

4. Refine protocols for LAg avidity testing to improve the accuracy and efficiency of HIV recency prediction.

2 months after Contract Award date

Ongoing COR

Task 1

5. Refine protocols to assess value of routine screening OD to predict HIV recency

2 months after Contract Award date

Ongoing COR

b. 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

c. Evaluate and monitor risk factor characteristics of donations confirmed positive for HIV, ARV, PrEP, PEP, or recently positive for HBV or HCV at participating blood collection organization(s)

d. Analyze ARV results in conjunction with other coded donor-related information, including demographics, geographic location, donation patterns, etc.

e. Evaluate and monitor risk factor characteristics of donors positive for HIV who manifest the presence of ARV metabolites.

f. Analyze PrEP/PEP results in conjunction with other coded donor-related information, such as demographics, geographic location, donation patterns, TTI test results, changes in blood manufacturing operations (e.g. DHQ modifications), etc. etc.

g. Administer surveys and qualitative interviews to further the scientific understanding of knowledge and motivations of individuals who donate blood while taking ARV or PrEP/PEP.

Information collection should be aligned with a generally accepted behavioral conceptual framework to support a structured assessment of individual motivations, barriers, and potential interventions based on known external influences, such as individual knowledge and attitudes, social and community norms, etc.

h. Develop and perform standardized risk interview survey(s), in accordance with administrative processes such as review and approval by Institutional Review Boards (IRBs) and Office of Management and Budget (OMB), as specified in Section 3.

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

j. Coordinate with the DDCC and 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

k. Conduct risk factor interviews by donor counselors via telephone of HIV infected donors and those using ARV/PrEP/PEP in order to determine if changes in the prevalence of risk behaviors associated with HIV are related to changes in compliance with the donor health history questionnaire, donor demographics, risk behaviors of donors, and the motivation for incompliance

l. Conduct risk factor interviews by donor counselors via telephone with donors exhibiting validated NAT-only test results for HBV and HCV infection since the likely “recency” of infection creates an opportunity to pinpoint actual exposures that led to infection

m. Establish procedures and processes within the protocol identified in 2.1.a 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

n. Develop an Analytical Plan detailing the methodology for risk factor analyses, genotyping/drug resistance analyses, and pertinent demographic, geographical and temporal trend analyses.

Specifically the plan shall:

i. 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

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

2 Task 2 Deliverables/ Work Products

2.3. TASK 3: PERFORM LABORATORY TESTING, DATA COLLECTION AND MANAGEMENT PERTINENT TO

CHARACTERIZATION OF TTI-POSITIVE DONORS AND THOSE IDENTIFIED AS USING ARV/PREP/PEP

OR OTHER MARKERS OF HIGH RISK BEHAVIOR

The Contractor shall perform the following activities in support of Task 2.2:

a. Closely collaborate/coordinate with the DDCC to ensure data transfers, cross-talk between datasets, and integration of efforts

Task Deliverable/Work Product Title

Due Date Table Quantity / Frequency

Delivered To

Task 2

6. Risk Interview Survey

Modifications to include PrEP/PEP/ARV questions

Within 45 calendar days after Contract award date Once COR, Committee

Task

7. Risk Factor Interviews Within in 21 calendar days of triggered event Ongoing COR

Task

8. Tracking of Follow-Up Investigations

Within in 21 calendar days of triggered event Ongoing COR

Task 2 9. Analytical Plan

Within 3 months after contract award date Once COR, Committee

Task

10. Analyze ARV/PrEP/PEP results

NLT 180 days after IRB & OMB approvals obtained Ongoing COR

Task

11. Analyze new and prior LAg avidity MDRI data from a stratified context specific perspective.

NLT 10 months after contract award Ongoing COR

Task

12. Investigate availability of longitudinal HIV s/c panels for study and report.

NLT 60 days after contract award Ongoing COR

Task

13. Investigate observation period-independent incidence trends.

NLT 180 days after contract award Ongoing COR

b. The contractor shall lead the task of integrating risk factor data and disease marker surveillance information across different blood collection organizations by closely working with the DDCC to obtain donation/donor data information

c. Perform sequencing of HIV (prevalent and incident), HBV, and HCV viruses from donors with newly acquired infections to monitor evolving molecular epidemiology of viruses in the donor population, drug resistance profiles of HIV, and to help ensure that donor screening assays are optimized to detect circulating strains of infections

d. Perform “recency” testing of HIV antibody positive donations to distinguish more recently acquired from longer-standing HIV infections, and improve classification of HIV incidence and provide data quarterly to allow the DDCC to optimally classify HIV-positive donors as incident or prevalent cases:

i. Apply HIV "recency" tests to all HIV seropositive samples obtained from the TTIMS program, as well as historical HIV+ samples provided by participating blood centers to assess baseline data over time for HIV “recency” among donors.

ii. Establish the performance of available "recency" assays in antibody positive donations for which an alternate measure of “recency” is available (e.g. prior recent seronegative or NAT yield donation to validate use of “recency” testing to distinguish recently acquired from longer-standing HIV infections among HIV seropositive donors unknown infection history.

e. Develop and test LAg test refinements to assist accuracy and efficiency of HIV incidence prediction.

Leverage initial and new results from HIV Sedia LAg avidity testing of TTIMS blood donor and other samples combined with viral load results, and potentially other testing such as p24 antigen to establish refined test procedures and results modeling in support of:

a. Improved predictive value for HIV mean durations of recent infection (MDRI) estimates b.Reduced HIV false recency estimates

c. Monitoring time trends in HIV incidence d.Demographic correlates of HIV incidence

e. Variations in individual HIV antibody responses and maturation kinetics

f. Correlations with changes in first time or repeat donor behavior over time that may reflect a change in blood safety e.g. a higher proportion of recently acquired HIV reflective of donor test-seeking

f. Investigate context-specific HIV MDRI for different populations across a range of LAg OD thresholds and for existing HIV seroconversion panels.

Analyze new and prior LAg avidity MDRI data from a stratified context-specific perspective.

Population subgroups should be defined by:

a. Demographic variations b.Geographic variations: US and international

c. Risk exposures (e.g. IDU vs MSM) d.HIV viral variants

e. Individuals exposed to ARV, PEP or PrEP

f. Validation of MDRI estimates vs. longitudinal seroconversion panels, where available

g. Explore performance of assays and analyses that may lead to new efficiencies for the derivation of HIV cross-sectional incidence estimates in screened populations (such as blood donors) with increased accuracy and reduced time and burden.

Required studies to include:

a. Development of protocol to assess value of routine screening OD to predict HIV recency and investigate observation period-independent incidence trends.

b. Investigate the potential for quantitative serological results from routine donation screening to serve as a marker of recent HIV infection for use in FT donor incidence estimation.

c. Develop methods to assess trends in HIV incidence based on Sedia LAg avidity data without sorting into discrete strata reflecting the period of observation

d. Analyze available test results from existing databases from TTIMS, and other sources for evidence that non-random test-seeking or deferral behaviors impacting the rates of HIV-infected donations can be identified by recency testing versus always assuming that acquisition of HIV is a random occurrence in the population under study.

h. Perform necessary follow-up and supplemental testing within seven (7) calendar days of initial discovery of positive results to confirm the presence of HIV, HCV or HBV infection to allow the DDCC to optimally classify donors’ infection status

i. Conduct batch testing of samples to monitor for the presence of ARV metabolites.

j. Conduct expanded larger scale batch testing and assessments of PrEP/PEP use among blood donors by obtaining historical and newly collected samples from US blood centers targeted to donors with demographic and geographic characteristics of interest.

Table 3 Task 3 Deliverables/ Work Products

2.4. TASK 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:

Task Deliverable/Work Product Title

Due Date Quantity / Frequency

Delivered To

Task 3 14. Risk Factor Data Surveillance Results

7th calendar day of the month Quarterly COR, Committee

Task 3

15. Batch testing for ARV metabolites Report By 7th calendar day of the following quarter Quarterly COR

Task 3

16. Lab testing (recency and

PrEP) result Report By 7th calendar day of the following quarter Quarterly COR

Task 3

17. Initiate refined testing procedures designed to improve the accuracy and efficiency of HIV recency prediction.

By 7th calendar day of the following quarter Quarterly COR

Task 3

18. Sequencing Data

Quarterly Report

By 7th calendar day of the following quarter

Quarterly

COR

Task 3 19. Testing Quarterly Report By 7th calendar day of the following quarter Quarterly COR

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.

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 4 Deliverables/ Work Products

2.5. TASK 5: COMMUNICATION AND OUTREACH

The Contractor shall act as a member of and actively participate in the TTIMS Committee and any assigned Subcommittees. Moreover, the contractor shall provide regular updates on work 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’s Principal Investigator (PI) shall attend face-to-face semi-annual Committee meetings located at Silver Spring, Maryland (1-day duration each) with the first meeting conducted within two months of contract award. Moreover, the Contractor’s Principal Investigator (PI) shall attend all

Task Deliverable/Work Product

Title Due Date Quantity / Frequency Delivered To

Task

20. Committee/Subcommittee Conference Calls, Meeting Minutes

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

Task

21. Committee/Subcommittee Agendas 5 calendar days prior to the meeting Monthly COR, Committee

Task

22. Central Electronic Repository of Meeting Minutes/ Calls/Action Items

Last business day of the month Ongoing COR, Committee

Task 4 23. Draft Technical Report

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

One COR

Task

24. Final Technical Report Final due at the end of contract’s period of performance

One COR

Task 4 25. Abstracts and Presentations

10 business days prior to submission or presentation

Anticipate one per year COR

Task 4 26. Reports and Manuscripts 30 calendar days prior to the agreed date Anticipate one per year COR

Committee and Subcommittee conference calls, at least once per month for the duration of the contract period of performance. The Contractor shall:

2.5.1 QUALITY CONTROL AND SITE VISITS

The LRCC Contractor shall conduct a minimum of two (2) site visits every year during the contract period to one of the participating blood collection organizations to address and remedy any issues encountered in the conduct of TTIMS activities related to the evaluation of the HIV, HCV and HBV positive donors.

2.5.2 EXTERNAL COLLABORATIONS

The Contractor shall collaborate with other Government Agencies and blood organizations. The Contactor shall submit requests for external collaborations and investigations to the COR and Committee for review and approval. All external collaboration requests shall be sent via written communication (e.g. email). The Contractor shall enable external collaborations and investigations that propose to use existing TTIMS data or resources to address additional research questions, as approved by the COR and the Committee.

Table 5 Task 5 Meetings

Table 6 Task 5 Deliverables/ Work Products

2.6. TASK 6: PROJECT/CONTRACT MANAGEMENT

Task Meeting / Activity Title Location(s) Estimated

Occurrences Receiving

Organization

Task 5 1. Committee Monthly Meeting

FDA White Oak Campus, Bldg 71 or teleconference One per Month Committee

Task 5

2. Semi-Annual On-Site

Meeting (to include PIs and some Committee Members)

FDA White Oak Campus, Bldg 71 Two per year Committee

Task 5 3. Committee Conference Call Teleconference Minimum Monthly Committee

Task 5

4. Subcommittee Conference

Call Teleconference Minimum Monthly Committee

Task Deliverable/Work Product

Title Due Date Quantity / Frequency Delivered To

Task 5 27. Written Site Visit Report 30 calendar days after each site visit

Minimum of Two yearly over the contract period

COR, Committee

Task 5

28. Written External

Collaboration Requests Prior to the 5th calendar day of each month Ongoing COR, Committee

2.6.1 FACILITIES

The Contractor shall provide facilities and equipment necessary to work with infectious materials, in order to accomplish the requirements as specified in task areas 3.1 through 3.4. Specifically, the Contractor shall provide facilities and equipment (i.e. BSL-3 facility) to complete biohazard containment procedures, which is required when working with infectious materials. Additionally the Contractor shall provide the capacities to store biological/infectious materials and specimens at -70° C (minus 70 degrees Celsius). Lastly, the Contractor shall ensure that electronic medical record data is captured, and retained and protected for future study purposes.

2.6.2 PROJECT MEETINGS AND STATUS REPORTING

The Contractor shall provide project/contract management to ensure that tasks stay on track and milestones, performance measures deliverables and work products are met. The Contractor shall participate in a kickoff meeting within three (3) weeks 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 5th calendar 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 each task

b. Identification of problem areas with recommended remedial actions

c. Challenges, issues, and risks

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.

2.6.3 QUALITY CONTROL

The Contractor shall deliver high quality data and information; follow FDA Statutes, Guidance, and Good Manufacturing Processes (GMP’s); which are required of all licensed blood collection organizations operating within the United States and deliver 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 analyses and interpretation of trends and their effects.

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 time frame specified with minimal errors and need for corrections.

e. The Contractor shall ensure the following:

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

• Key Personnel shall be on board 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 that shall be addressed in order for the overall effective 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 (in writing) to the responsible party and the FDA, and have identified dates for completion.

2.6.4 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 chosen. At a minimum, this Transition-Out Plan shall 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 and MOP;

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 – Deliverables, Inspection and Acceptance.

3 CONTRACT CONSTRAINTS

The following constraints are applicable to this contract:

1. Blood Donor Survey modifications shall be recommended by the Committee and approved by the COR following receipt of all necessary administrative/regulatory approvals. This includes applicable Institutional Review Boards (IRBs), and Office of Management and Budget (OMB).

2. Blood collection organizations will collect, process, and store bio-specimens until the LRCC coordinates the shipments.

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

4. The Contractor shall ensure that all administrative and regulatory approvals are obtained as described in the MOP and LRCC Protocol by any participating blood collection organizations before TTIMS data collection begins. These include but are not limited to those that address

Deliverable/Work Product Title

Due Date Quantity / Frequency

Delivered To

29. Transition-Out Plan 90 calendar days prior to contract expiration One/Once CO, COR human subject considerations; and clearances including applicable Institutional Review Boards (IRBs), and Office of Management and Budget (OMB).

5. The DDCC 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 maintained by the DDCC and LRCC. These unique identifiers will accompany the data files transmitted from the DDCC to the LRCC and vice versa.

i. The identity of the blood donors will be known only to the blood center investigator (s) and will not be provided to the LRCC. 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.

6. Interim data used in technical progress reports and other reports developed for the purpose of study monitoring and 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.

7. Legend for Technical Progress Reports Containing Interim Study Data

i. The Contractor shall incorporate the following legend on the cover 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."

8. 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).

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

3 Contract Constraints