FDA_19-233-1209847_Attachment_1_Statement_of_Work_.pdf

HIV Risk Questionnaire (HRQ) Study: An Assessment of the Predictive Value of a Panel of Questions for Recent Infection with Human Immunodeficiency Virus (HIV)

Attachment 1 Statement of Work (SOW)

Statement of Need:

The U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) / Office of Biostatistics and Epidemiology (OBE) requires a service provider to conduct an HIV Risk Questionnaire (HRQ) Study / Assessment of the Predictive Value of a Panel of Questions for Recent Infection with Human Immunodeficiency Virus (HIV) Men who have Sex with Men (MSM) for a base 1-year period with up to two (2) option 1-year periods.

Background:

The 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.

The use of specific deferral questions, donor educational material, and donor testing (i.e. blood donor screening) have reduced the risk of HIV transmission from blood transfusion. The FDA has revisited its donor deferral recommendations intended to reduce the risk of transmitting human immunodeficiency virus (HIV). Studies have found that the majority of new HIV infections were attributable to male-to-male sexual contact.

The FDA continues to work to review its donor deferral policies to ensure they reflect the most up-to-date scientific knowledge. Policies must be data-driven, so the timeframe for future changes is not something that can be predicted. Therefore, the FDA proposes to conduct the following study to assess whether an alternative MSM donor deferral strategy that minimizes HIV risk could be a reasonable alternative to the current approach.

Study Objectives The purpose of this MSM blood donor study is to provide the FDA with evidence by which to consider changes in policy from the current deferral interval for Men who have Sex with Men (MSM). Scientific and technical oversight for the study will be provided by the US FDA.

Primary Objective:

• Conduct an initial assessment of the discriminant function of revised donor history questions for predicting recent infection with HIV in MSM who wish to donate blood.

Secondary Objectives:

• Evaluate the recency of infection in those individuals who test positive for HIV by individual NAT and antibody testing;

• Identify risk factors associated with recent HIV infection in individuals who are antibody negative yet HIV NAT positive.

Study Minimum Requirements:

The Contactor:

• Single Contractor or study coordinating center (SCC) with multiple subcontractors for data coordination and analyses, administration of questionnaires, specimen collection, specimen testing, study subject follow-up, and counseling, OR a Contractor or SCC shall conduct most functions including data coordination/analyses, administration of questionnaires, conducts follow-up but enlists one or only a few subcontractors to complete one or a small number of functions (e.g. specimen testing).

• Shall be responsible for standardization and harmonization of all data sources to the same high-quality level.

• Shall be responsible for all work streams with all data providers.

• Shall be responsible for all results from work streams and data providers into the final analysis.

• Shall be responsible for generation of final work products.

• Shall communicate with all partners to clarify timelines, deliverables, and expectations.

• Shall identify and provide or subcontract with appropriate scientific experts.

• Shall establish two committees within 30 calendar days of the contract award, an

Executive Committee (EC) and a Steering/Monitoring Committee (SMC).

• Shall meet no less than quarterly including in person at least twice a year and by teleconference on the remaining occasions. Unforeseen circumstances may arise requiring additional communication, which would likely be by teleconference.

• Shall report findings and recommendations for discussion and any necessary action by the committees or subcommittees formed on an as needed basis to address issues and specific priorities.

• Shall solicit and incorporate feedback on the reports generated, as well as identify any weaknesses and make recommended changes.

• Shall develop a Manual of Procedures providing specific details, processes and plans for carrying out the study, and determine the background rate of HIV for the population to be studied.

• Shall be responsible for updating documents as the project evolves and changes are necessary to reflect the most current practice.

• Shall coordinate, conduct the survey and analyze the survey data, the specimen collection and testing, the follow-up portion of the pilot, and provide logistical support for the full pilot program.

• Shall provide summaries and estimates of survey results, HIV prevalence, incidence, behavioral risk factors, and residual risk of potential MSM donors blood safety HIV risk.

In general, FDA will not receive nor handle private individual data from study subjects but shall receive summary data and summaries of findings.

The following tasks constitute the performance of work expectations for this study.

This study may help determine the feasibility and size of a larger study to determine whether reduction or elimination of the donor deferral interval for MSM is possible. The criteria for proceeding to such a larger study will be the determination that a set of responses to the behavioral questions posed in this study is associated with the absence of detection of recent HIV infection.

Task 1: Establish Executive Committee and Steering/Monitoring Committee

Contractor shall establish an Executive Committee (EC) and a Steering/Monitoring Committee (SMC) within 30 calendar days of contract award.

The EC shall meet monthly by teleconference and be comprised of the Principal Investigators (PI), and Co-PIs representing participating organizations, and government representatives from the FDA and other Department of Health and Human Services (DHHS) Agencies.

The EC shall review and analyze data and reports on a regular basis, the results of any investigation and analyses (e.g., temporal trends in incidence and prevalence), and meet as necessary to carry out the functions required under this proposal. FDA staff and analysts are available to consult and provide advice to the Contractor on items such as study design, analytic approaches, analyses and related areas.

The SMC shall include the PI and Co-PI and appropriate representation from subcontractors.

FDA and the SMC provide review of the MOP, protocol and documents and provide written feedback to the Contractor to address. The SMC shall meet no less than quarterly by teleconference and in person at least once. Unforeseen circumstances may arise requiring additional communication among SMC or EC members between meetings, which would likely occur by teleconference.

Table 1 Task 1 Deliverables/ Work Products

Task 2: Establish Study Protocol and Procedures

Contractor shall develop and finalize study protocol and MOP. The FDA Project Officer (or his/her designee) and the FDA COR must approve the protocol and Manual of Procedures (MOP) before their implementation.

Task Deliverable/Work Product Title Due Date Quantity /

Frequency Delivered To

Task 1.1

Establish Executive Committee (EC)

Within 30 days of Contract Award Once COR

Task 1.2

Establish Steering/Monitoring Committee (SMC)

Within 30 days of Contract Award Once COR

a. Contractor shall coordinate with the FDA to finalize the design of the study including recommending alternatives that would improve the efficiency and utility of the outcomes.

The design specifications are detailed below in Sections 2.3 through 2.6.

b. Contractor shall develop and deliver a written MOP and the protocol, including the background rate of HIV for the population to be studied and coordinate with the SMC to finalize them. Procedures shall address at a minimum the following: survey implementation, specimen collection procedures and handling, laboratory procedures, shipping and storage, management and tracking, consensus definitions, security, data security and management, transfer, and data sharing considerations.

c. Contractor shall prepare materials which the FDA will submit to the Office of Management and Budget (OMB) for study approval. This approval may require substantial time (i.e., 6 to 9 months) and should be initiated as soon as the required materials are established and approved by FDA.

d. Contractor shall prepare materials which the FDA and contractors will submit to their respective Institutional Review Boards (IRBs) for study approval. The Contractor shall provide access and meet all IRB requirements to conduct the study.

e. Contractor shall develop and implement secure and robust data collection, data quality control, tracking, management, and storage procedures for TTI-positive blood donor related data and bio-specimens relevant to subjects’ survey results and evaluations.

f. Contractor shall comply with the Federal Information Security Modernization Act of 2014 and meet HHS and FDA security standards for the management of Personal Health Information (PHI) and computer systems requirements.

g. Data and analysis reports shall be submitted to the Committee for their assessment on a regular basis as per the terms of the contract. Guidance is to be provided by the EC. The EC shall be responsible for reviewing the data reports and results of analyses provided by the contractor.

h. Contractor shall identify a testing laboratory to perform the individual HIV antibody and individual NAT blood testing.

i. Contractor shall develop procedures and training materials for specimen collection and processing.

a. Contractor shall provide training, and, as appropriate, conduct site visits to address and remedy issues encountered at participating organizations relevant to the conduct of the pilot.

j. Contractor shall develop procedures, training, and tools to ensure the quality collection, transmission, curation, and storage of data related to the questionnaires and to the specimens.

k. Contractor shall establish a working committee of survey site managers to provide ongoing updates and input on obstacles encountered.

l. This Task includes at least one site visit per study site.

Table 2 Task 2 Deliverables/ Work Products

Task 3: Selection of Study Population

In order to assess the feasibility of eliminating or reducing the donor deferral interval through use of revised blood donor questions in conjunction with mini-pool NAT, a sample of 2,000 individuals potentially interested in donating blood who have sex with men at least once during the past 3 months will be enrolled. The sample size has been calculated to be able to detect at least one window period infection with HIV if the panel of additional behavior questions is not effective in identifying individuals at risk for recent HIV infection.

Individuals shall be drawn from 8 to 12 sites geographically distributed across the United States with a concentration on those locations where epidemiology indicates continued significant transmission of HIV within the MSM community. Sites may be a combination of clinical facilities and venue-based testing (vans at bars and events that attract large numbers of potential subjects, e.g., pride events). Contractor shall select locations from the high prevalence HIV states and cities list below.

Based on CDC epidemiology reports, the following states have the highest rates of newly diagnosed HIV infections: Georgia, Louisiana, Florida, Nevada, and Maryland with rates above 20/100,000 persons (https://www.cdc.gov/hiv/statistics/overview/geographicdistribution.html).

Other states with rates between 15-20/100,000 persons include Texas, South Carolina, New York, Mississippi, North Carolina, New Jersey, and California. Cities with the highest rates are Baton Rouge LA, Miami FL, New Orleans LA, Jackson MS, Orlando FL, Memphis TN, Atlanta GA, Columbia SC, Jacksonville FL, and Baltimore MD.

Following identification of the geographically distributed study sites, Contractor shall provide the FDA a written report that includes the identity of the study locations, the recruitment plan at each study location, the responsible investigator(s) at each site, and also include site demographics (e.g. population served), and sample estimates.

Study inclusion criteria:

Task Deliverable/Work Product Title Due Date Quantity /

Frequency Delivered To

Task

2.1 Study Protocol NLT 60 days after

Contract Award date Ongoing COR, SMC

Task 2.2

Draft Manual of Procedures

(MOP)

NLT 60 days after Contract Award Once COR, SMC

Task

2.3 Final MOP 2.5 months after Contract

Award Once COR, SMC

Task 2.4

Prepare OMB Package for submission

2.5 months after Contract Award Once COR

Task 2.5

Prepare IRB Package for submission

3 months after Contract Award date Once COR, SMC

Task

2.6 Written Site Visit Report 30 calendar days after site

visits Once COR, SMC https://www.cdc.gov/hiv/statistics/overview/geographicdistribution.html

1) Male

2) At least 18 years of age and no more than 30 years of age

3) Willingness to donate blood at some time in the future

4) Participated in oral sex or anal intercourse with a male partner at least once during the past 3 months

5) Able to answer the study questionnaire, provide a blood sample, and follow the study protocol

6) Able to provide informed consent

7) Subjects drawn from a variety of regions in the US

Study Exclusion criteria (Blood donor exclusion categories):

1) Any prior use of injection drugs ever

2) Any exchange of sex for money or drugs ever

3) Any prior documented history of HIV infection diagnosis of syphilis, gonorrhea, or chlamydia during the 3 months prior to enrollment

Table 3 Task 3 Deliverables/ Work Products

Task 4: Administration of Questionnaire

Contractor shall implement the approved questionnaire, the mode of data collection, the training materials associated with the questionnaire, and testing. OBM approval is to be sought under Task 2.4, following Contractor development of the OMB Package. Contractor may be responsible for providing responses to OMB questions to FDA. The OMB process can add additional time to the study timeline (approximately 6 to 9 months). The administration of the questionnaire and collection of samples cannot commence until OMB approval is received, accordingly, most of the project work will not start until the end of the first year or the early part of year two. Contractor will need to plan and budget resources accordingly.

While the OMB package is in review, Contractor shall conduct a small pilot of the questionnaire with no more than 9 subjects. This pilot is intended to identify any issues with the questionnaire, the in-person delivery, and/or the data collection methodology. A pilot report shall be submitted to the SMC.

Task Deliverable/Work Product Title Due Date Quantity / Frequency Delivered To

Task 3.1

Report of Study Site Selection:

Describe identity of study locations, Responsible persons, site recruitment plan, site demographics, and sample estimates.

1 month after Contract Award date Once COR

Upon receipt of OMB approval, the OMB-approved questionnaire shall be translated into Spanish, with appropriate training of center staff to be able to administer it to Spanish-speaking study subjects.

Contractor shall document training of all survey staff on the protocol and survey procedures, including initial questionnaire delivery and data capture, and follow-up interview and counseling techniques.

Study will involve in-person administration of a questionnaire, preferably using electronic tools, by trained survey staff, the collection of a 7 mL blood sample by a trained phlebotomist, and when appropriate, administration of a follow-up questionnaire through an in-person subject interview combined with appropriate counseling and referral. Survey shall be administered by staff trained on the survey administration procedure, HIPAA and confidentiality of records and data. Data are to be collected through a secure survey design into a confidential data repository

Study enrollment is expected to take approximately six months and data analysis is expected to be completed within 12 months.

Participants will be contacted twice over the course of the study. Contact 1 is the initial enrollment, a questionnaire, and a blood draw. Contact 2 is a second interview and a blood draw. The two contacts should take place over a less than 14-day period.

Contractor shall propose the mechanism to share data from the data collection sites and the laboratory. Contractor shall also propose a data security plan for linking and storing data for analysis which should be included in the protocol.

Contractor shall develop and implement secure and robust data collection, tracking, management, data quality control/quality assurance, data security plans and storage procedures for TTI test result, demographic, first-time/repeat status, and other blood donor/donation data from participating study sites. Contractor shall closely collaborate/coordinate with all parties to ensure appropriate data transfers and cross-talk between datasets. Contractor shall provide all necessary and relevant data management/tracking systems to the participating organizations, as needed. Computer programs, data management systems, databases, and other resources developed through this contract shall comply with data standards and computer security procedures established by FDA and DHHS.

Those individuals meeting the study eligibility criteria (Task 3) and providing informed consent will complete a brief history questionnaire.

The questions will include the following:

1) How many different male sexual partners have you had sex with (defined as oral sex or anal intercourse) with during the past

a. 1 month (number_____)

b. 3 months (number_____)

c. 12 months (number_____)

2) What kind of sex have you had with another man during the past month?

a. Oral sex

b. Anal penetrative or receptive intercourse

c. Both oral sex and anal intercourse

d. Not sexually active during the past month

3) To your knowledge, have you had sex with an HIV positive partner during the past 12 months? (yes/no)

4) Do you

a. Always use condoms

b. Use condoms sometimes

c. Never use condoms

5) Have you ever taken pre-exposure prophylaxis (PrEP)? (yes/no).

a. If yes, when was the last time that you took PrEP? ___________

Table 4 Task 4 Deliverables/ Work Products

Task Deliverable/Work Product Title Due Date Quantity /

Frequency Delivered To

Task 4.1

Data management and security plan

2 months after Contract Award Once COR

Task 4.2

Conduct questionnaire pilot with 9 subjects

2 months after Contract Award Once COR

Task

4.3 Pilot Report

Within 2 weeks after pilot completion Once SMC/COR

Task 4.4

Translate OMB approved questionnaire into Spanish

After receipt of OMB approval Once COR

Task 4.5

Administer study questionnaires

Within 30 calendar days after OMB and IRB approvals received

Ongoing until the sample size is reached at 8-12 sites

COR

Task 4.6

Complete administration of questionnaires for entire sample

Until the sample size of 2,000 subjects is reached, with complete data for all subjects at all sites

Ongoing COR, SMC

Task 5: HIV Testing:

A blood sample will be taken from all enrolled individuals and used for HIV testing using a test licensed for blood donor screening. This could be accomplished through subcontracting with a blood center testing laboratory. Accordingly, the Contractor shall:

• Conduct individual Antibody testing for HIV using a licensed test for blood donor screening, and

• Conduct individual donor Nucleic Acid Amplification Testing (NAT) for HIV using a licensed test for blood donors.

o If sample is positive by either antibody or NAT for HIV, the Contractor shall conduct recency testing for HIV. Recency testing (such as the Limiting-antigen avidity (LAg) test) of HIV antibody positive donations is used to evaluate whether infectious are recently acquired (e.g. within the past two weeks) and provides a deeper understanding of HIV incidence trends, demographics and behavioral correlates of newly acquired HIV infection. Without recency testing (such as by LAg Avidity testing), it is not possible to estimate recency of infection in first time donors, such as these MSM previously deferred for life. Previous risk factor studies of HIV-positive donors in the US such as the most recent assessment done between 2011-2013 by the REDS-II program identified very few NAT-only or NAT-yield infections (14 for HIV in 2 years, 2011-2012). Instead, most donors had seroconverted at the time of donation.

Although dual HIV serology and NAT positive donors have a very high probability of being identified through donation testing, establishing time estimates of HIV acquisition relative to the date of blood donation is important to ascertain aspects of potential test seeking behavior and to be able to more precisely quantify the incidence of newly acquired HIV infection. Classification of recently acquired HIV cases into time windows of acquisition relative to the HIV-positive donation will be done using recency testing and other HIV confirmation testing results on the index sample (or potentially on a follow-up sample if available).

o Perform necessary in-person follow-up and supplemental testing within seven (7) calendar days of initial discovery of positive results to confirm the presence of HIV.

Contractor shall provide regular reports of the results of the antibody testing, individual unit NAT, recency, and follow-up testing.

Contractor shall retain and make available to FDA all study blood samples and original study data for a period of one-year from the end of the performance period for the contract, if needed for follow-up.

Table 5 Task 5 Deliverables/ Work Products

Task Deliverable/Work Product Title Due Date Quantity /

Frequency Delivered To

Task 5.1

Test blood samples for HIV using licensed blood donor antibody test and

Within 3-5 days of sample collection Ongoing COR

Task 6: Follow-Up:

An in-person follow-up visit will be scheduled approximately one week following the first visit for all study subjects. At that visit (Contact 2), test results will be provided to all subjects.

Additional historical information will be obtained from those with positive HIV blood tests, and HIV counseling and HIV treatment referral for follow-up will be provided.

Contractor shall propose a follow-up visit protocol to include:

• Provision of test results to each subject

• Counseling on test results outcomes

• Referral to HIV treatment for HIV positive subjects

• Capture of additional information about subject’s risk specific to his answers on the questionnaire

Contractor shall submit the follow-up visit protocol to FDA.

Contractor shall provide monthly reports to FDA and the SMC on the numbers of subjects that comply with the study protocol and complete their follow-up visits.

Table 6 Task 6 Deliverables/ Work Products

Task 5.2

Test blood samples for HIV using licensed individual blood donor Nucleic Acid Amplification Testing (NAT)

Within 3-5 days of sample collection Ongoing COR

Task 5.3

Test all NAT positive blood samples for HIV recency.

Within 7 days of positive test result Ongoing COR

Task 5.4

Report HIV Testing Results and progress toward complete study accrual

Monthly after testing begins Monthly EC/SMC

Task 5.5

Retain all samples and original study data

For a period of one-year from the end of the performance period

Once COR

Task Deliverable/Work Product Title Due Date Quantity /

Frequency Delivered To

Task 6.1 Follow-up Visit Protocol 2 months after Contract Award Once COR/SMC

Task 6.2 Follow-up visits including risk factor Interviews

Within 7-14 calendar days of questionnaire completion and sample draw

Ongoing COR

Task 6.3 Monthly Follow-up visit report Monthly after recruitment begins Monthly EC/SMV

Task 7: Analysis of Data Contractor shall be responsible for analysis of study results including questionnaire outcomes, test results, and their integration. Contractor shall develop an analysis plan that includes a description of all proposed analyses and shall include data specifications, dataset structures, table specifications for summary results, statistical plan, any proposed data modeling, and data quality control procedures. Any proposed modeling shall require mock analysis runs to assure that analytical tools and procedures are robust.

The analysis plan shall be submitted in draft form to FDA for review and comment. Final analysis plan shall incorporate FDA’s input.

Contractor shall perform quality control (QC) procedures on the data collected in order to assure accuracy of analyses. Contractor shall include a description of these procedures in the analysis plan and will conduct QC on the data as it is compiled. Contractor shall report on the results of the QC activities and the overall quality of data received from the study sites and any potential impact on final study results.

Contractor shall conduct data analysis on the data collected at mid-point of data collection (approximately three months after data collection begins). Written report shall include analysis of data collected to date and include mid-point table generation, a summary of trends and findings, QC results, and shall include the identification of any data-related study issues, their causes and any steps taken to mitigate and prevent their continuation.

At the completion of the study, Contractor shall prepare a draft Analysis Report for FDA review and comment that includes all completed elements of the analysis plan, analysis of completed study data and tables, a summary of trends and findings, QC results, and a summary of any data-related study issues and their resolution.

The Contractor shall produce a Final Analysis Report that incorporates FDA input.

Table 7 Task 7 Deliverables/ Work Products

Task Deliverable/Work Product Title Due Date Quantity /

Frequency Delivered To

Task 7.1 Draft analysis plan Within 3 months of the Contract Award date Once COR

Task 7.2 Final analysis plan Within 4 months of the Contract Award date Once COR, EC

Task 7.3 Written report of mock analyses conducted

Within 1 month of accepted Final Analysis Plan Once COR

Task 7.4 Written report of performed quality control procedures on the data and report results

Within 30 days after data collection closes. Ongoing COR

Task 8 Project/Contract Management

Contractor shall provide project/contract management to ensure that tasks stay on track and milestones, performance measures deliverables and work products are met. 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 FDA staff and discuss the contractor’s approach to meeting the requirements of the SOW.

The Executive Committee (EC) shall meet monthly and be comprised of the Principal Investigators (PI), and Co-PI representing participating organizations, and government representatives from the FDA and other Department of Health and Human Services (DHHS) Agencies. Data analyses and reports provided by the Contractor will be reviewed by the COR and EC members.

The Steering/Monitoring Committee (SMC) 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.

The SMC will coordinate discussions of the HIV marker, demographics, and survey components of the study; prepare agendas; prepare and distribute review materials for the meetings/calls; and take and distribute minutes and/or action items of the meetings/calls to participants, and the FDA Contracting Officer Representative (COR) within 20 working days of the meeting/call.

Table 8 Task 8 Meetings

Task 7.5 Mid-point Analysis Report Three months following start of data collection Once COR, EC

Task 7.6 Draft Analysis Report Within 1 month of the close of survey Once COR, Committee

Task 7.7 Final Analysis Report Within 2 months of the close of survey Once COR, Committee

Task Meeting / Activity Title Due Date/Location Estimated Occurrences Participants

Task 8.1 Kick-off Meeting Within 10 calendar days of contract award FDA White Oak Campus, Bldg 71

Once COR, Contractor

Task 8.2 EC Committee Monthly Meeting Teleconference Minimum

Monthly

COR,

Committee

Task 8.3 Semi-Annual SMC Meeting FDA White Oak Campus, Bldg 71 Two per year COR, Committee

Task 8.4 SMC Monthly Meeting Teleconference Minimum Monthly

COR,

Committee

Task 9: Reporting/Logistical Support 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

Contractor shall schedule and provide administrative support for all Committee (EC/SMC) 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. Prepare a draft final report for FDA review and comment

f. Produce a final report incorporating FDA input.

Contractor shall produce a draft final and final report that incorporates study results, provision of primary data 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. In performing this task, Contractor shall include information about selection of study sites, subject accrual rate and demographics. FDA will not receive individual data such as test results, recency testing results, etc. Contractor shall provide results in aggregate or summary formats. The draft final and final report should also include a summary of the MSRs including challenges encountered by Contractor and study sites, their resolution, and recommendations appropriate for incorporating into future studies.

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

Table 9 Task 9 Deliverables/ Work Products

Task Deliverable/Work Product Title Due Date Quantity /

Frequency Delivered To

Task 9.1 Monthly Progress reports Monthly on the 5th for the previous month Monthly COR

Task 9.2 Committee/Subcommittee Agendas

5 calendar days prior to the meeting Monthly COR, Committee

Task 9.3 Committee/Subcommittee Conference Calls, Meeting Minutes

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

Task 9.4 Central Electronic Repository of Meeting Last business day of the month Ongoing COR, Committee

Task 10: Quality Control

Contractor shall deliver high quality data and information; follow FDA, federal and relevant 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.).

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

c. 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. 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

Contractor shall be proactive in informing the 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.

Contract Constraints The following constraints are applicable to this contract:

1. Blood Donor Survey modifications shall be 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. Contractor shall provide the computer and tracking systems, necessary freezers, containers, and other supplies to properly and safely transfer, handle and store the bio-specimens/samples.

3. Contractor shall ensure that all administrative and regulatory approvals are obtained as described in the MOP and Protocols before survey data collection begins. These include

Minutes/ Calls/Action Items

Task 9.5 Draft Final Report 30 calendar days prior to the end of the performance period Once COR

Task 9.6 Final Report incorporating FDA input

End of the performance period Once COR 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), processes for Steering Committee and FDA review and clearance of findings necessary prior to communication, presentation, publication or other forms of public release.

4. Contractor will provide a unique identification number (ID) for each subject allowing their survey responses and test results to be linked in the databases maintained by the Contractor.

i. The identity of the subjects will be known only to the contractor and will not be provided to the FDA. Participating survey sites shall maintain the link between the unique study subject ID and the sample ID to allow them to contact the subject for appropriate follow-up.

ii. The link between study subject ID and sample ID or other identifiers shall be kept in a secured location at the participating survey sites.

5. 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.

6. Legend for Technical Progress Reports Containing Interim Study Data

i. 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."

7. 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