Justification_and_Approval_Redacted.pdf

Justification and Approval for Sole Source

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. HHS.

Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse, Office of Acquisition

b. Sponsoring organization.

Department of Health and Human Services National Institutes of Health National Center for Advancing Translational Sciences

c. Project Officer information.

Project Officer name.

Mailing address.

Division of Clinical Innovation (DCI) National Center for Advancing Translational Sciences 6701 Democracy Blvd Bethesda, MD 20892-4874

E-mail address.

Telephone number.

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives.

The purpose of this action is to award a sole source research and development (R&D) contract titled “ACTIV-1 Time-limited Biospecimen Storage and Related Services (COVID-19)” to Technical Resources International, Inc. (TRI), 6500 Rock Spring Drive, Bethesda, MD 20817- 1197. The Government intends to award a cost-plus-fixed-fee type contract for non-severable R&D services.

b. Project background.

To meet the unprecedented public health crisis created by the COVID-19 pandemic, the National Institutes of Health (NIH) announced on April 17, 2020, the Accelerating COVID-19 Therapeutic Interventions and Vaccines

AP ATTACHMENT 3

(ACTIV) public-private partnership to develop a coordinated research strategy for prioritizing and speeding development of the most promising treatments and vaccines. Coordinated by the Foundation for the National Institutes of Health (FNIH), ACTIV brought NIH together with its sibling agencies in the Department of Health and Human Services, including the Biomedical Advanced Research and Development Authority (BARDA), Centers for Disease Control and Prevention (CDC), and the U.S. Food and Drug Administration (FDA); other government agencies including the Department of Defense (DoD) and Department of Veterans Affairs (VA);

United States Government COVID-19 Response; the European Medicines Agency (EMA); and representatives from academia, philanthropic organizations, and numerous biopharmaceutical companies.

One of the programs established within the ACTIV framework was the Therapeutics Development Working Group that was charged with rapidly organizing and implementing clinical trials using adaptive platform trial designs that could test multiple agents and use shared control groups to accelerate testing and obtain much needed answers quickly to help guide clinical care of COVID-19 patients.

NIH’s National Center for Advancing Translational Sciences (NCATS) and BARDA are leading one of the ACTIV trials, ACTIV-1. NCATS coordinated and oversaw the ACTIV-1 trial in partnership with and with funding from BARDA. TRI is a contractor that is part of BARDA’s medical countermeasures clinical studies network. BARDA awarded TRI Task Order (TO) Number 75A50120F33002 under Contract Number HHSO100201400002I to support the management of ACTIV-1 Master Protocol. The period of performance for the BARDA TO is from 08/17/2020 to 09/30/2022. The total dollar amount obligated to date is $83,003,730.00. The BARDA TO award was competed under full and open competition.

The ACTIV-1 Master Protocol is a randomized, double-blind, placebo-controlled platform trial that enrolled 1,971 hospitalized adults with moderate to severe COVID-19 at 46 medical facilities in the U.S. and 23 medical facilities in the Latin America. The trial evaluated infliximab (REMICADE®), developed by Janssen Research & Development, LLC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson;

abatacept (ORENCIA®), developed by Bristol Myers Squibb; and Cenicriviroc (CVC), an investigational late-stage agent developed by AbbVie. Each agent was evaluated as add-on therapy to the current standard of care for hospitalized COVID-19 patients, which included remdesivir for most participants (supplied by the study). The research objectives were to evaluate each agent with respect to speed of recovery, mortality, illness severity, and hospital resource utilization.

TRI supported BARDA and NCATS in the management of the ACTIV-1

Master Protocol by overseeing the trial operations, including contracting, management of necessary subcontractors, data management, data monitoring, site monitoring, international site selection and management, statistical support, investigational product and biospecimen repository, international regulatory assistance, and contracting of a commercial central Institutional Review Board (IRB).

During the trial, research samples of whole blood, serum and plasma were collected from the consented study participants at approximately 46 medical facilities in the U.S. These biospecimens are currently stored in a commercial repository under the supervision of TRI. A portion of these biospecimens have been used for cytokine, inflammatory markers and SARS-CoV-2 serology assays as part of the exploratory assessments stated in the ACTIV-1 Master Protocol and the remaining biospecimens will be available for investigators or entities interested in conducting secondary research. In addition, data collected from the consented participants is stored and managed by a data coordinating center (DCC) under the supervision of TRI. The DCC will provide selected de-identified clinical data matched with the biospecimens for the exploratory assessments and secondary research.

This project is a continuation of selected ongoing activities under the BARDA TO and to establish new activities. These include time-limited storage, distribution, destruction (if needed) of biospecimens and de-identified clinical data, data management support to match de-identified clinical data subsets with biospecimens, additional statistical analyses for ACTIV-1 study, biospecimens analysis, collection and management of Material Transfer Agreements (MTAs) and Data Use Agreements (DUAs), and IRB review after conclusion of the BARDA TO on September 30, 2022.

3. Description of the supplies or services required to meet the agency’s needs

(including the estimated value).

a. Project title.

ACTIV-1 Time-limited Biospecimen Storage and Related Services

(COVID-19)

b. Project description.

See Attachment 1: Statement of Work (SOW) for a full description of the requirement.

Requirement type.

Research & development (R&D) R & D support services Support services (non-R&D) Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

Type of action.

New requirement Follow-on Other (specify):_____________________

Proposed contract/order type.

Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ Time and materials Indefinite Delivery, Indefinite Quantity Other (specify): ___________ Completion Form Term form

Acquisition identification number.

Requisition Number 6219249 and proposed Solicitation Number 75N95022R00057.

c. Total estimated dollar value and performance/delivery period.

This task order has five (5) non-severable components: a Base and four

(4) Options for increased quantity-separately priced line items. The estimated dollar values of the Base and Options are as follows:

Base for ACTIV-1 time-limited biospecimen storage and related services (COVID-19) with an estimated dollar value of $1,872,974.

Option Quantity One (1) for statistical support. This Option has an estimated dollar value of $248,597 and may be exercised two (2) times during the contract period of performance for a total estimated dollar value of $497,194.

Option Quantity Two (2) for biospecimen analysis. This Option has an estimated dollar value of $498,836 and may be exercised one (1) time during the contract period of performance for a total estimated dollar value of $498,836.

Option Quantity Three (3) for regulatory support. This Option has an estimated dollar value of $20,087 and may be exercised one (1) time during the contract period of performance for a total estimated dollar value of $20,087.

Option Quantity Four (4) for governance logistics support. This Option has an estimated dollar value of $42,680 and may be exercised one (1) time during the contract period of performance for a total estimated dollar value of $42,680.

The total estimated dollar value of the acquisition, inclusive of options, is $2,931,771; and the total performance period for these non-severable activities is three years.

4. Identification of the statutory authority permitting other than full and open competition.

This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 3304(a)(1) as set forth in Federal Acquisition Regulation (FAR) 6.302-1.

This acquisition is conducted under the authority of 41 U.S.C. 1901.

This acquisition is conducted under the authority of 41 U.S.C. 1903.

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

Technical Resources International, Inc. (TRI) 6500 Rock Spring Drive Bethesda, MD 20817-1197

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

TRI has unique qualifications to provide the services for this requirement and is the only organization that can complete the specific work at this time. TRI is in a unique position to provide the continuity of the existing activities under the BARDA TO and to establish the new activities as the resources required for these activities are already in place.

TRI is the only contractor that has been an integral part of the ACTIV-1 Master Protocol implementation since the trial was launched. TRI is the only organization with familiarity and deep knowledge of the complex platform trial data to perform additional analyses necessary to better understand the relationships of baseline SARS-CoV-2 serology status, biomarkers and cytokines to the overall clinical course of patients with COVID-19 and their responses to immune modulators treatment.

Awarding this contract to a new vendor would impose duplication of costs and unacceptable delay during the transition. Duplicated costs include building up efficient operations, orientation and training of personnel to understand, manage and analyze the clinical and biospecimen data, and shipping of approximately 16,600 biospecimens to a new repository. Labor of personnel involved in the project management, laboratory facilities, quality assurance and statistical support is estimated at 600 hours. Shipping costs are estimated at $3 per unit (approximately $49,800 for 16,600 units).

The harms caused by unacceptable delay include destruction of biospecimens after the end of period of performance of the BARDA TO (as NCATS does not have the facilities to store the biospecimens until a new contract is awarded), inaccurate data analyses due to lack of familiarity of complex platform trial, the potential risk of damage to the biospecimens or breach of ACTIV-1 clinical data during the transition between TRI and a new vendor.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

Efforts were taken to solicit as many potential offerors as possible. In accordance with FAR Subpart 5.2, a synopsis of proposed contract action to negotiate and award a contract to TRI was published electronically on SAM.gov Contract Opportunities on May 14, 2022, for fifteen (15) days and closed on May 29, 2022. The synopsis included a statement that all responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency. No responses to the notice were received. See Attachment 5: Pre-solicitation Non-Competitive Notice of Intent.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

The Independent Government Cost Estimate (IGCE) for this requirement is $2,931,771.00 and is included as Attachment 2. The cost/price for this award will undergo a price analysis and cost realism analysis in accordance with FAR Part 15. Certified cost and pricing data will be required. If applicable, pre-negotiation objectives will be established and discussions conducted, and a summary of negotiations documented. Before an award is made the source selection award decision memorandum will document the Contracting Officer’s (CO’s) determination that the final proposed award amount is fair and reasonable. Audits are not expected to be performed; however, the award files will be subject to quality control programs ordinarily conducted by NIH and or

HHS.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

A small business sources sought (SBSS) notice to help determine the availability of qualified companies technically capable of meeting the Government requirement was published electronically on SAM.gov Contract Opportunities on January 14, 2022, for fifteen (15) days and closed on January 29, 2022. See Attachment 3: Small Business Sources Sought Notice. No responses were received to the SBSS Notice. Additionally, the CO conducted keyword searches on the UNICOR, AbilityOne, and GSA Advantage websites for “biospecimen storage” which produced either no or no relevant results. See Attachment 4: Supporting Market Research. Finally, as noted under Item 6.

above, a pre-solicitation non-competitive notice of intent was also published electronically on SAM.gov Contract Opportunities on May 14, 2022, for fifteen

(15) days and closed on May 29, 2022. No responses to this notice were received either.

9. Any other facts supporting the use of other than full and open competition.

This requirement will be critical for COVID-19 research, and TRI is the only contractor with the experience and knowledge to perform the work as summarized under Item 5 above. In addition, market research identified no other capable sources for this requirement and no responses were received from any interested parties to public notices published on SAM.gov as summarized under Item 8 above. Despite the above circumstances, if this requirement were nevertheless competed under full and open competition, it would result in an unacceptable delay in fulfilling the agency’s needs. Separate technical evaluations would be required for each proposal received, even if they were all ultimately determined to be technically unacceptable, resulting in administrative time, effort, and cost from the Government and unnecessarily delaying award of a contract for the requirement. In addition, negotiation of an acceptable transition plan and transition timeline would further delay the issuance of the contract award to address an urgent need to perform the work as summarized under Item 5 above after September 30, 2022.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

No responses were received to the sources sought and pre-solicitation notices published on SAM.gov. No other sources have expressed an interest, in writing, in the proposed acquisition.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

There are no future plans at this time to acquire the same type of services by further extensions, competitive renewals, or other means. At the end of the contract, all biospecimens and data will be distributed or destroyed.

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

ACTIV-1 Time-limited Biospecimen Storage and Related Services (COVID-19)

STATEMENT OF WORK (SOW)

Date: 05/24/2022

1. General Information

1.1. Title of Project

ACTIV-1 Time-limited Biospecimen Storage and Related Services (COVID-19)

1.2. Statement of Need and Purpose

The National Center for Advancing Translational Sciences (NCATS) needs continuing support of selected existing activities under the Biomedical Advanced Research and Development Authority (BARDA) Task Order (TO) number 75A50120F33002, contract number HHSO100201400002I and to establish new activities. These include time-limited storage, distribution, destruction (if needed) of biospecimens and de-identified clinical data, data management support to match de-identified clinical data subsets with biospecimens, additional statistical analyses for ACTIV-1 study, biospecimens analysis, collection and management of Material Transfer Agreements (MTAs) and Data Use Agreements (DUAs), and Institutional Review Board (IRB) review after conclusion of the BARDA TO on September 30, 2022. Research samples of whole blood, serum and plasma were collected for future research from the consented study participants enrolled in the ACTIV-1 Immune Modulators (IM) Master Protocol trial from approximately 46 medical facilities in the U.S., but the BARDA TO does not provide for time-limited storage and related services after the conclusion of the ACTIV-1 IM trial. These biospecimens can provide critical data about the COVID-19 pandemic. At the end of project, the contractor shall provide a final report describing the outcomes and progress of each of the required tasks and deliverables.

1.3. Background Information

To meet the unprecedented public health crisis created by the COVID-19 pandemic, the National Institutes of Health (NIH) announced on April 17, 2020, the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership to develop a coordinated research strategy for prioritizing and speeding development of the most promising treatments and vaccines.

Coordinated by the Foundation for the National Institutes of Health (FNIH), ACTIV brings NIH together with its sibling agencies in the Department of Health and Human Services, including the BARDA, Centers for Disease Control and Prevention (CDC), and the U.S. Food and Drug Administration (FDA); other government agencies including the Department of Defense (DoD) and Department of Veterans Affairs (VA); United States Government COVID-19 Response; the European Medicines Agency (EMA); and representatives from academia, philanthropic organizations, and numerous biopharmaceutical companies.

One of the programs established within the ACTIV framework was the Therapeutics Development Working Group that was charged with rapidly organizing and implementing clinical trials using adaptive platform trial designs that could test multiple agents and use shared control groups to accelerate testing and obtain much needed answers quickly to help guide clinical care of COVID-19

ATTACHMENT 1

patients. NCATS and BARDA supported one of the ACTIV trials, ACTIV-1 IM, and implement the trial using the 60 U.S. academic centers comprising the NCATS Clinical and Translational Science Award (CTSA) Program, plus additional non-CTSA U.S. sites and sites outside the United States. This procurement will provide assistance to maintain and provide additional services for ACTIV-1 as described below.

1.4. Period of Performance

The period of performance (POP) shall consist of a three-year base period.

1.5. Scope of Work

The Contractor shall provide all the necessary services, qualified personnel, tools, materials, equipment, and facilities, not otherwise provided by the Government to perform the Statement of Work (SOW) herein:

1.5.1. Task 1: Project Management

1.5.1.1. Project Management Plan

a) Within 30 business days of the contract award, the Contractor shall submit to the Contracting Officer’s Representative (COR) and Contracting Officer (CO) for approval, one copy each of the Project Management Plan.

b) Describe the overall organization that addresses the planning, initiation, implementation, conduct, monitoring, and completion of tasks identified in the SOW. If consultants and/or subcontractors are proposed, include a plan to manage, coordinate, and oversee the work performed by consultants and/or subcontractor(s).

c) Describe the roles, responsibilities, and level of effort for all scientific and technical personnel, including all proposed subcontractors and consultants.

d) Provide an administrative and technical framework indicating clear lines of authority and responsibility for all proposed personnel. Identify the point(s) of contact for communication. Include a chart of the proposed organizational/management structure for the project.

e) Describe the project management systems that will be used to track activities and to keep multiple activities on time and budget. The plan must include a description of the quality control methods that will be used to ensure the effective and efficient initiation, implementation, management, and oversight of contract requirements.

1.5.1.2. Communication Plan

a) Within 30 business days of the contract award, the Contractor shall submit to the COR and CO for approval, one copy each of the Communication Plan.

b) Outline how the Project Director will communicate with the COR and CO and how the Project Director will communicate, monitor, and manage the project both internally and externally (at subcontractor facilities).

c) Outlines communication goals and strategies for the tasks described in the SOW.

d) Develop and implement communication Standard Operating Procedures (SOPs) for management of biospecimen inventory and clinical data with the NIH or designated party within 30 business days of the contract award.

1.5.1.3. Quality Management Plan

a) Establish and maintain Quality Assurance (QA) and Quality Control (QC) Programs that includes valid SOPs in accordance with best practices and covers all activities critical to the successful operation of the biorepository and clinical data management. The QA/QC Program shall include, but is not limited to:

1. A description of the commitment to QA and QC and approaches for ensuring that the requirements of the QA and QC programs are met;

2. Validating procedures for long-term storage of each material type of biospecimen and clinical data management;

3. Development and maintenance of SOPs;

4. Developing a data management plan for the storage of the de-identified clinical data including a data backup system.

5. Monitoring the mechanical functioning of freezers and other storage equipment including alarm and back-up systems;

6. Monitoring the flow of biospecimens into, within and out of the Contractor’s facilities;

7. Packaging and shipping of biospecimens to the designated third parties in the

U.S. only;

8. Receiving biospecimens and clinical data from the ACTIV-1 Contractor;

9. Verifying accuracy of data entry, inventory database, and shipping and receipt records;

10. Validating protocols for withdrawal and destruction of biospecimens;

11. Ensuring biospecimen integrity;

12. Ensuring compliance with all Federal, State and local requirements and current best practices;

13. Records management; and

14. Emergency response plan.

b) Conduct an internal audit of the storage facilities within 30 business days of contract award and yearly thereafter.

c) Notify COR of any QA/QC issues and corrective actions within 5 business days of occurrence.

d) Submit, within 30 business days of the contract award, a detailed protocol for QA/QC to the COR. The Contractor shall complete revisions specified by the COR within 10 business days of receipt and submit the final version for approval by the COR.

e) Initiate and implement approved procedures within 45 business days of the contract award.

1.5.1.4. Reports and Meetings

a) Plan and conduct an initiation meeting with the COR and designated NCATS representatives (hereafter referred as NCATS) via teleconference to orient the contract process within 5 business days of contract award.

b) Plan and conduct regular meetings (up to 4 meetings per month) between the Contractor’s key personnel and the COR, CO and NCATS via teleconference, to review overall progress, discuss incoming and outgoing shipments, policies for acceptance, retrieval and storage of specimens, review protocols, the status of approved projects, and to discuss any matters relevant to the scientific and financial administration of the contract and future activities.

c) Prepare and distribute the agenda and meeting materials to all participants at least 2 business days prior to the meeting. Provide meeting minutes 3 business days after the meetings.

d) Provide a summary of all meetings, teleconferences, and description of the activities performed during the following Technical Progress Reports

1. Quarterly Progress Report

2. Annual Progress Report.

3. Final Report

1.5.2. Task 2: Biospecimen Management

Each biospecimen is unique and cannot be replaced if lost, damaged or contaminated. Therefore, it is essential that the biospecimens be stored under optimal conditions to maintain their integrity and biological properties, which vary from biospecimen type to biospecimen type. Storage facilities with the College of American Pathologist’s (CAP) Biorepository Accreditation is preferred.

The Contractor shall comply with all Federal, State, and local requirements and current best practices for the collection, handling, preservation, storage, retrieval, and distribution of biological material for scientific research including:

The National Cancer Institute Best Practices for Biospecimen Resources.

The International Society of Biological and Environmental Repository Best Practices for

Repositories. Standards for biologically hazardous materials as Biological Substance Category B, UN3373.

Shipments shall comply with current standards as indicated by Federal, State, and local government regulations, as well as the International Air Transport Association (IATA) Guidance Document for Infectious Substances.

OSHA standards 29 CFR 1910.1030 and Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition for handling biological specimens with potential or known blood borne or other potentially infectious pathogens

a) Develop and maintain detailed SOPs for biospecimen management. Provide SOPs for COR comment within 20 business days of contract award. Complete revisions specified by the COR, and submit the final version within 10 business days for approval by the COR.

b) Develop and maintain detailed SOPs for training of contractor personnel involved with biospecimen management, storage, and distribution of biospecimens.

c) Develop communication SOPs for receipt, distribution, and destruction of specimens with ACTIV-1 leadership. Update contact information on an annual or more frequent basis.

d) Execute any necessary agreements to transfer the biospecimens into the Contractor’s facility.

1.5.2.1. Receipt of Biospecimens

a) Receive biospecimens containing specimen identifiers from the ACTIV-1 Contractor.

Biospecimens include up to 16,000 serum or plasma aliquots and up to 600 PAXGene DNA tubes stored in cryoboxes.

b) Inspect all shipments, documentation, and all incoming biospecimens for obvious damage, breakage, spillage, or thawing, if frozen. Note and reconcile any discrepancies.

c) Confirm the quantity and integrity of biospecimens received according to the inventory manifest from the ACTIV-1 Contractor.

d) Record specimens into an electronic inventory system within 30 business days.

1.5.2.2. Storage of Biospecimens

a) Determine and store specimens under optimal storage conditions for each type of specimen received (e.g., storage in cryoboxes at temperature -80 degree Celsius) to minimize loss, degradation, damage, or contamination.

b) Provide facilities that are safe, secure, and appropriately temperature- controlled and equipped with fire, security failure, smoke, and mechanical failure alarms, and appropriate fire control equipment. Ensure that key Contractor personnel are available and notified in case of fire, mechanical failure of one or more freezers, or any other emergency (natural or man-made). A member of the Contractor’s key personnel shall be available to be notified 24 hours a day, 7 days a week including weekends, holidays, and closures due to other emergencies.

c) Provide facilities with emergency back-up generators with the capability of handling the complete power supply in the case of an electrical power failure. Establish a plan to ensure that adequate fuel is available for the generator(s) and that the generators are routinely tested to ensure proper operation. Test back-up generators in a situation of complete power failure. Maintain and test all generators and safety equipment according to manufacturer’s instructions.

d) Maintain 10% excess storage capacity for each storage condition in “ready to use” status to serve as back-up units in the event of freezer failure.

1.5.2.3. Distribution of Biospecimens

a) Receive and process requests from the NIH or designated party for distribution of biospecimens to the designated third party. Distribution of biospecimens includes retrieving, packaging, handling, and coordinating shipments to U.S. locations.

b) Utilize validated procedures for retrieval, preparation, and distribution of biospecimens as requested by the NIH or designated party.

c) Provide appropriate shipping containers and all associated packing materials, including dry ice.

d) Provide biospecimen data and storage information to the NIH or designated party.

e) Prepare to ship the requested number and type of biospecimens to the designated third party within 5 business days of request on monthly basis, using methods that ensure the viability and integrity of the biospecimens. Verify receipt of each shipment.

f) Pay shipment costs that include specimen retrieval, packaging, and shipment to the designated third parties (U.S. only).

g) With input and assistance from NCATS, draft appropriate MTA template that will be used to transfer biospecimens to the designated third party. The MTAs must be consistent with Federal law and NIH human biospecimen transfer policies.

h) Execute any necessary MTA with the designated third party receiving the biospecimens.

i) Track all MTAs prior to releasing requested biospecimens. On a monthly basis, provide the COR with report of all executed MTAs, that include recipient, recipient organization and summary of biospecimens transferred.

1.5.2.4. Destruction of Biospecimens

a) Establish procedures for designating biospecimens to be removed and determining that biospecimens will be destroyed.

b) Retrieve and destroy the biospecimens within 5 business days and record the reason for destruction in the laboratory information management system.

c) Notify COR of destruction of specimens.

d) At the direction of COR destroy all biospecimens within 5 business days at the end of contract.

1.5.3. Task 3: Data Management

Develop and maintain detailed SOP(s) for data management. Provide SOPs for COR comment within 30 business days of contract award. Complete revisions specified by the COR, and submit the final version within 10 business days for approval by the COR.

a) Execute any necessary agreements to transfer the de-identified clinical data into the Contractor’s facility.

b) Develop and maintain detailed SOPs for training of contractor personnel involved with the storage and distribution of de-identified clinical data.

1.5.3.1. Biospecimen Tracking

a) Receive data files (manifests) containing biospecimen identifiers from the ACTIV-1 Contractor.

b) Employ a laboratory information management system to provide detailed tracking of receipt, storage, retrieval, distribution, and destruction of biospecimens.

c) Employ laboratory information management system to store and retrieve QA/QC information associated with the biospecimens.

d) Manage the biospecimen inventory in collaboration with the NIH or designated party by providing the requested data files (e.g., csv format).

1.5.3.2. Clinical Data Management

a) Receive via secure file transfer and verify clinical data files (source Medidata’s Rave Electronic Data Capture) containing clinical data from the ACTIV-1 Contractor.

Data formats include raw datasets in XPT/SAS files, Study Data Tabulation Model (SDTM) datasets and Analysis Data Model (ADaM) datasets with approximately total size of 30 GB.

b) Adjust analyses, reports, or data file formats (i.e., csv files) as directed by the NIH COR.

c) Provide data management including correlation of clinical data files with specimen data files and retrieval of the data elements in format (e.g., csv files) as requested by the NIH or designated party. Data management of any biospecimen analysis data generated by the designated third party is the responsibility of the third party.

d) With input and assistance from NCATS, draft appropriate DUA template that will be used to transfer de-identified clinical data to the designated third party. The DUAs must be consistent with Federal law and NIH human de-identified clinical data policies.

Execute and track all DUAs prior to releasing requested biospecimens. On a monthly basis, provide the COR with report of all executed DUAs, that include recipient, recipient organization and summary of de-identified clinical data transferred.

1.5.4. Task 4: Statistical Support

Provide statistical support to correlate clinical data with the specimen data for accurate transfer of the dataset matching the biospecimens.

2. Options

a) Option Quantity 1 – Statistical Support

This separately priced line-item option will add up to a maximum of 2,400 hours for the following statistical support:

a. Collaborate with ACTIV-1 leadership to conduct additional statistical analyses needed for the publication of secondary research.

b. Collaborate with the ACTIV-1 leadership to implement the statistical analysis plan for the biomarker analysis. Statistical analysis of any biospecimen analysis data generated by the designated third party is the responsibility of the third party.

b) Option Quantity 2– Biospecimen Analysis This separately priced line-item option will add the following biospecimen analysis:

a. Collaborate with the ACTIV-1 leadership to perform biomarker/cytokine analyses using commercial customized or standard immunoassay panels for up to 3,000 samples.

c) Option Quantity 3– Regulatory Support This separately priced line-item option will add the following regulatory support for up to thirty-six (36) reviews by the Institutional Review Board (IRB):

a. The IRB should review and approve a protocol specifying the conditions under which data and specimens may be accepted and shared, and ensuring adequate provisions to protect the privacy of subjects and maintain the confidentiality of data. The IRB should also review and approve a sample collection protocol and informed consent document for distribution to tissue collectors and their local IRBs.

b. Provide regulatory support for ACTIV-1 related activities requiring human subject protection oversight to include support from an Office of Human Research Protections

(OHRP) approved IRB.

d) Option Quantity 4– Governance Logistics Support This separately priced line-item option will add up to a maximum of 252 hours for the following project management support:

a. Coordinate, facilitate, and manage the requests for the biospecimens and matched clinical dataset from third party (end users).

b. Coordinate with NIH or designated party in the review and approval of secondary research from third party (end users).

c. Coordinate, facilitate, and manage the approved requests for the biospecimens and matched clinical dataset to third party (end users).

3. Government Furnished Information

The Government shall:

3.1. Provide the Contractor with the contact information for the NIH Inventory Contractor.

4. ICT Accessibility Requirements

Products, platforms, and services delivered as part of this work statement that are Information and Communications Technology (ICT), or contain ICT, must conform to the Revised 508 Standards, which are located at 36 C.F.R. § 1194.1 & Apps. A, C & D, and available at https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines.