RISER Meet and Greet Announcement Phase I.pdf

Centers for Disease Control and Prevention (CDC)

Resources for Improvement of Surveillance and Emergency Response

(RISER)

Virtual Large and Small Business Meet and Greet – Call for Large Business Information (Phase I)

This posting is in connection with the following announcements:

• Notice ID: 75D30124R73168 (Sources Sought – Resources for Improvement of Surveillance and Emergency Response (RISER)) published on August 16, 2024.

• Notice ID: 75D301-TBD-R-72996 (Industry Day Special Announcement) originally published on May 2, 2024.

This announcement is not a solicitation. This announcement does not constitute an invitation for bid, request for proposal, or request for quotation and is not to be construed as a commitment by the government. This is for informational purposes only; the government will not reimburse any costs associated with attending the meet and greet.

This announcement is phase one in a three-phase process that will be accomplished by the publication of this announcement and by amending it for future phases. Below is a summary of the phases:

1. Phase I – call for interested large businesses.

2. Phase II – publish information received from large businesses and initiate call for interested small businesses.

3. Phase III – provide the link and finalized dates/times for the virtual meet and greet once the final number of large and small businesses is known.

PHASE I – CALL FOR INTERESTED LARGE BUSINESSES

Interested parties shall respond to this notice no later than November 14, 2024 (2:00 PM Eastern Time).

Email your responses to Jennifer Gartzke at jgartzke@cdc.gov. An emailed response confirming receipt will be sent once the information is received by the CDC. If you have not received a confirmation email by close of business November 15, 2024, please email the Contracting Officer at the email address above at your earliest convenience.

The CDC is seeking interested large businesses under NAICS 325413 In-Vitro Diagnostic Substance Manufacturing with the current capabilities to provide the services outlined in the attached Performance Work Statement (PWS). The intent of this announcement is to obtain a list of qualified large businesses that would be interested in providing proposals for the attached PWS. The CDC will publish the list of interested large businesses and ask for interested small businesses who could potentially provide services via subcontracts. CDC will then provide a Zoom conference line that will allow businesses to meet to begin to establish a relationship. Do not provide a proposal for this requirement; the CDC is only asking for the information listed below in the announcement at this point.

In order for this to be an effective exchange, the government requests the following information from interested large businesses:

mailto:jgartzke@cdc.gov

• UEI

• One page capability statement

• Primary NAICS

• Relevant past performance at either the prime or subcontracting level

• Point of contact to include name, email, and telephone number

• Parts of the PWS that the large business would be interested in subcontracting

This information will be published via an amendment to this notice on SAM.gov for small businesses to review. Small businesses will be given the opportunity to then provide their information via email (more details to be provided in the Phase II announcement) and will be able to provide a list of large businesses they are interested in meeting with based on their capabilities and the large business’ subcontracting needs. The Phase III announcement will provide the date, time, finalized list of attendees for the meet and greet. The Zoom link will be emailed privately to the point of contact listed in the response as requested above to the small and large businesses who responded to Phases I and II.

TENTATIVE INFORMATION ABOUT THE MEET AND GREET

The meet and greet conference will be conducted over one business day tentatively (depending on the number of responses) beginning at 9 am Eastern Time on December 11, 2024.

Audience: Members of industry

When: December 11, 2024 (tentatively)

Where: Virtual via Zoom

Address: Zoom link to be provided at a later date

Section C - Description/Specification/Work Statement

STATEMENT OF WORK

CDC’s Resources for Improvement of Surveillance and Emergency Response

(RISER)

I. BACKGROUND AND NEED

The Centers for Disease Control and Prevention (CDC) is responsible for the detection and response to new and emerging health threats to protect the safety and health of Americans whether diseases start at home or abroad. In carrying out its mission, CDC works with partner public health laboratories both domestically and internationally, to provide technical expertise and guidance to enhance laboratory capability and capacity. This assistance ensures that public health actions are made objectively and based upon the highest quality of scientific data. Additionally, CDC responds to emergency responses related to disease outbreaks by assisting with the implementation of appropriate assays to support early interventions and prevention strategies, which could prevent an aggressive outbreak from becoming an epidemic and/or pandemic.

To help protect the health of Americans, CDC’s laboratory scientists work in more than 200 cutting-edge laboratories across the United States. These laboratories are housed across seven Centers: 1) National Center for Emerging and Zoonotic Infectious Diseases (NCEZID); 2) National Center for Immunization and Respiratory Diseases (NCIRD); 3) National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP); 4) Center for Global Health (CGH); 5) National Center on Birth Defects and Development Diseases (NCBDDD); 6) National Center for Environmental Health (NCEH); and 7) National Institute for Occupational Safety and Health (NIOSH). Though each laboratory Center carries out different critical work, all conduct applied research on disease prevention and control. Further, most laboratory Centers conduct surveillance and research to determine disease distribution, determinants, and burden both nationally and internationally to aid with policy decision activities. Lastly, many laboratory Centers are charged with deploying diagnostic tests and tools, such as advance molecular detection technology, that helps scientists detect health threats more quickly and create new ways to rapidly test for infectious pathogens in the field.

As a result of the National Strategy for Pandemic Influenza, issued by President Bush on November 1, 2005, which guided our nation’s preparedness and response to an influenza pandemic, the CDC NCIRD’s Influenza Division, sponsored the “CDC Influenza Reagent (CDC-IRR) contract”. This was a ten-year contract designed to provide laboratory support to public health professionals as necessary to minimize the impact of an influenza pandemic on the health of Americans. More specifically, the CDC-IRR contract served (a) to ensure that adequate stocks of influenza viruses, positive controls, kits, proficiency panels and other research materials were available on a routine basis to CDC and other partner researchers in order to adequately characterize circulating seasonal and novel viruses and (b) ensure the ability to quickly ramp up production and distribution activities to surge levels in the event of a pandemic or public health emergency.

Based on the success of the CDC-IRR contract, its collaboration with Global Health Security Agenda (GHSA), and success of CDC’s response to the 2015 Zika virus outbreak (during which CDC and CDC-partner GHSA and Zika researchers benefited from availability of reagents and research materials common and/or similar to those being made available to influenza researchers under the CDC-IRR contract), NCIRD determined that it would be beneficial to the public health, and appropriate, to expand the scope of the CDC-IRR contract beyond influenza. In 2019, a newly created contract allowed for the production, acquisition, and distribution of reagents to domestic and international public health partners, for the detection of influenza, bacterial and non-influenza viral pathogens. Because of this expansion, CDC-IRR was able to be quickly activated to aid with emergency response efforts associated with SARS-CoV-2 pandemic, and most recently U.S. domestic responses to Mpox and Ebola outbreaks.

This enterprise contract, serving CDC’s seven laboratory Centers, is a critical component of CDC’s efforts to ensure the availability of quality reference pathogens and other reagents to CDC and partner researchers for surveillance and public health responses. It also serves to enhance the CDC’s ability to provide on-site technical assistance to state and local public health laboratories and commercial developers of vaccines, antiviral drugs, and diagnostic tests; in support of our common goal to minimize the impact of bacterial, viral, and respiratory diseases in humans. Further, it builds on successful platforms to expand the network of CDC laboratories that can use this mechanism to further protect the safety and health of Americans; and in doing so adhere to the goals of President Biden’s 2022 National Biodefense Strategy and Implementation Plan.

II. PROJECT OBJECTIVES

The primary core objectives of this contract are:

1. To produce or acquire high quality stocks of reference pathogens, positive controls, detection kits, genomic sequencing components, proficiency panels and other similar type of surveillance and research reagents.

2. To ensure that these reagents, and any other ancillary material critical to the performance of surveillance and other public health-related laboratory activities, are available to the CDC, its public health laboratory partners, and researchers and developers for characterization of circulating and novel pathogens.

3. To ensure the ability to ramp up acquisition, production, and distribution activities to surge levels as may be needed to meet the needs of a public health emergency.

The optional objective of this contract is:

1. To develop and validate workflow or scientific processes for the development of assays to aid in pathogen characterization.

III. SCOPE OF WORK

The contractor shall produce or otherwise acquire, characterize, store, and distribute CDC-furnished pathogens and other reagents, including ancillary reagents critical to the performance of CDC-developed assays as described in Appendix A – Deliverables. This includes live and inactivated viruses, bacteria, vector-borne pathogens, nucleic acids, antisera, proteins, cell lines, hybridomas, and monoclonal antibodies. Unless otherwise requested by the government, for production of molecular diagnostic tests, the contractor shall establish multiple award task order mechanisms with government pre-qualified subcontractors, in accordance with quality specifications outlined in Appendix B – Quality Specifications.

The purpose of RISER reagents is to assist in characterization of pathogens as part of CDC surveillance activities; to aid in the development, evaluation, validation and testing of diagnostic products; to support vaccine development; and to support other research activities that increase awareness, knowledge, and understanding of the public health issues related to these pathogens. The RISER inventory of pathogens and other reagents will be regularly updated during contract performance to ensure that the catalog reflects current circulating or novel pathogen strains relevant to the ongoing surveillance and research activities of CDC and its partner laboratories.

All reagents produced by the contractor, or its subcontractors shall be in accordance with the format and quality specifications as described in Appendix B – Quality Specifications. All RISER reagents shall be manufactured according to a recognized national or international quality standard such as ISO 9001, US current good manufacturing practices, or comparable standards. Manufacturing batch records documenting all production processes and quality control (QC) testing for every lot shall be maintained by the contractor and available for CDC review upon request. Contract deliverables include materials that are regulated by the Food and Drug Administration (FDA) such as in vitro diagnostic Influenza Real-time RT-PCR kits.

The government may perform an annual review of contractor facilities to ensure that they conform to the requirements of FDA’s Quality System Regulations/Medical Device Good Manufacturing Practices; see 21 CFR Part 820, https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySyst emsRegulations/default.htm

Upon approval from CDC, RISER reagents that have met all required quality specifications shall be made available to registered persons and institutions via a RISER website managed by the government. The contractor shall communicate with both the RISER website as well as the government’s Customer Relationship Management (CRM) system to process reagent order requests, manage, and document all shipping logistics to recipient laboratories. The contractor shall also disseminate to the government any data associated with product distribution including but not limited to material and shipping costs.

IV. DETAILED TECHNICAL CORE REQUIREMENTS

Independently and not as an agent of the government, the contractor shall provide all management, labor, facilities, materials, supplies, and equipment necessary to operate and maintain the “Resources for Improvement of Surveillance and Emergency Response (RISER)” as set forth below.

More specifically, the contractor shall:

A. Develop Standard Operating Procedures (SOPs)

1. Prior to performance of any task requirement of this contract, the contractor shall develop draft SOPs consistent with the methodology and approach reflected in the contractor’s technical proposal to confirm proper contractor receipt, handling, storage and shipment of pathogens, and other reagents; and contractor performance of all contract tasks. For kit or material production requiring technology transfer of the SOP from the government to the contractor, the government may provide up to a 1-week assay training at CDC or at the vendor’s facility.

2. Draft SOPs shall be prepared for each Statement of Work (SOW) task, including quality assurance (QA) and QC assays associated with compliance to quality specifications, and submitted to the to the Contracting Officer’s Representative (COR) for approval prior to implementation. Separate SOPs will be submitted for each requirement. Individual SOPs shall be submitted in phases rather than all at the same time to facilitate the review and approval process.

3. The contractor shall submit technical SOPs to confirm how the contractor and their subcontractors plan to manufacture the various pathogens, and other reagents listed in Appendix A – Deliverables, in accordance with the format and quality specifications described in Appendix B – Quality Specifications of the contract. Individual production and QC protocols shall be required for each item and submitted to the government for approval prior to implementation to ensure manufacture of materials that meet or exceed the government’s inspection/acceptance criteria for that item.

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/default.htm https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/default.htm

4. All other contractor draft SOPs shall be provided to the COR for review and comment within 60 days of contract award. The COR shall review draft SOPs and furnish written comments to the contractor within 30 days of receipt. The contractor shall address COR comments in writing and submit revised SOPs to the COR for final review and approval within 120 days of contract award. The COR shall approve revised SOPs or furnish additional comments to the contractor within 15 days of receipt.

5. Final COR approval of the SOP for each individual task shall be obtained before the contractor shall be authorized to initiate any work under that task. Contractor SOPs shall be in full compliance with all international, federal, state, and local laws and regulations and World Health Organization guidelines, especially with respect to biosafety and security. The contractor’s institutional QA management will be required to approve SOPs prior to release of such materials.

6. Prior to initiation of task, contractor staff may receive assay training by CDC staff at the contractor’s facility.

B. Facility Requirements

1. The contractor shall provide dedicated facilities and equipment to receive, handle, propagate, aliquot, fully characterize, vial, weigh, store, and ship BSL1 reagents as well as potentially hazardous pathogens while maintaining their activity and/or viability under BSL2, BSL2 enhanced, BSL3, and BSL3 enhanced containment conditions, as appropriate. Storage and handling of infectious highly pathogenic agents shall be conducted only in laboratories that are registered for work with highly pathogenic agents under the United States Federal Select Agent Program. BSL-4 facilities may be required under this contract. Information regarding requirements for these facilities can be found at Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition | CDC Laboratory Portal | CDC

2. The contractor shall have accredited Animal BSL2, Animal BSL2 enhanced and Animal

BSL3 enhanced facilities as governed by the Institutional Animal Care and Use Committee (IACUC) and Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC), or ABSL3 teamed with an ABSL 3 Enhanced Laboratory for purposes of this acquisition. These laboratories shall be registered for work with highly pathogenic agents under the United States Federal Select Agent Program.

3. Facility design and SOPs for storage conditions shall include validation procedures and all necessary evidence that the integrity of RISER reagents and associated stocks will be maintained, and the risk of accidents or contamination is minimized.

4. Contract deliverables include materials that are regulated by the FDA such as in vitro diagnostic Influenza Real-time RT-PCR kits. The government may perform an annual review of contractor facilities to ensure that they conform to the requirements of the FDA’s Quality System Regulations/Medical Device Good Manufacturing Practices and laboratory, storage and shipping facilities shall be available for government inspection as part of the competitive proposal evaluation process; see 21 CFR Part 820, https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirement s/QualitySystemsRegulations/default.htm

5. Proof of registration with the Federal Select Agent Program, e.g. certificate, to demonstrate approved laboratory facilities, personnel, and SOPs for work with highly pathogenic and exotic avian influenza viruses and/or other respiratory pathogens of human and animal origin shall be provided as part of the contractor’s technical proposal submission.

https://www.cdc.gov/labs/BMBL.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fbiosafety%2Fpublications%2Fbmbl5%2Findex.htm https://www.cdc.gov/labs/BMBL.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fbiosafety%2Fpublications%2Fbmbl5%2Findex.htm https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/default.htm https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/default.htm

6. The contractor shall provide suitable air-conditioned floor space sufficient for the installation, storage and maintenance of equipment and all items necessary for the pathogen storage and distribution operation. Refrigeration and cryogenic equipment units will be housed in an air-conditioned facility with the capacity to maintain a room temperature of 66 to 72 °F, when all equipment is operational.

7. The contractor shall provide, maintain, and operate facilities for the storage of viral, bacterial, and vector-borne pathogen collections and derived reagents at 2 to 8°C, at -10 to -20 °C, at - 70 to -90 °C, and liquid nitrogen conditions.

8. The contractor shall provide uninterruptible power supply to accommodate the refrigerators/freezers and other critical security and surveillance equipment.

9. The contractor shall ensure that refrigerators, freezers, and incubators are connected to a central alarm system that is monitored 24 hours per day. Emergency stand-by refrigerators and freezers shall be available in case of mechanical failure of storage space. In the case of deviations outside of acceptable storage conditions, contractor shall halt distribution of all potentially impacted reagents until released by CDC and provide the information listed below regarding the affected storage unit/area (additional information may be required depending on the situation):

a) identification of all reagents/lots housed within, including quantity;

b) temperature profile/record of the event;

c) validation records, including thermal mapping if available;

d) alarm history, including the six weeks prior to the event;

e) current procedures for monitoring temperature/alarm point;

f) status update on corrective/preventative actions;

10. The contractor shall provide, maintain, and operate surveillance systems to assure that the stored materials are accessible only by authorized personnel. The contractor should utilize a state-of-the-art electronic security system with fail secure locking hardware to ensure controlled access to all the designated reagent storage areas of the contractor’s facility. A minimum of two separate levels or layers of physical and electronic security shall be employed. These levels of security may be increased at any time during the life of the contract if the federal government’s security guidelines for facilities are modified.

11. The contractor shall develop and implement procedures to track and catalog at both prime and subcontractor locations the handling and manipulation of the stores of pathogens and materials related to these agents. All computer systems shall utilize state-of-the-art software firewalls, computer security systems and encryption approved by Department of Health and Human Services (DHHS) and other computer software to prevent unauthorized access to the computer system and to prevent ‘hacking’ by those outside the secure system. A separate electronic record-keeping system shall be established for Select Agents.

12. The contractor shall establish an administrative audit and control SOP to ensure that RISER reagents distributed to requestors have met all the requirements set forth by the provider of the pathogen and the COR.

13. The contractor shall provide protective garments, equipment and sufficient training and monitoring to assure safe handling of biohazard materials. More specifically, the contractor shall comply with all applicable health and safety regulations and standards while performing the requirements of this contract. Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition | CDC Laboratory Portal | CDC

D. Establish, Maintain, and Operate the RISER Catalog https://www.cdc.gov/labs/BMBL.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fbiosafety%2Fpublications%2Findex.htm https://www.cdc.gov/labs/BMBL.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fbiosafety%2Fpublications%2Findex.htm

1. The contractor shall produce or procure RISER reagents as authorized by the COR in accordance with the deliverables listed in Appendix A – Deliverables and the QC tests and acceptance criteria described in Appendix B – Quality Specifications.

2. The contractor shall maintain QC of all RISER-manufactured reagents under this contract, including those manufactured under the terms of a subcontract. QC includes assay and evaluation of reference reagents following established SOPs that incorporate QC procedures as part of an overall QA program. QC testing shall be performed to confirm consistency of reagent performance and integrity as defined by CDC standards.

3. Ancillary reagents purchased off-the-shelf from commercial vendors may be excluded from additional QC testing by the RISER contractor. However, the contractor shall immediately notify the COR of any product recalls or other similar type notifications from the original vendor regarding reagent quality or performance that relates to lots either currently in inventory or distributed in the past.

4. QC and QA functions shall be independent from manufacturing, with the authority to quarantine and reject non-conforming materials.

5. QC and QA activities will ensure that assay SOPs utilized by the laboratory are approved in advance by the CO, fully validated for use, and supported by published evidence of reliability with regards to key performance parameters.

6. CDC may perform independent verification QC testing of functional performance of all

RISER-manufactured reagents at bulk, post-fill (filled vials), and final production stages to confirm that reagents meet all defined acceptance criteria.

7. Contractor shall develop a comprehensive production plan (including manufacturing process flow), track progress, assign resources, and analyze workloads in Microsoft Project or similar project management software. The production plan shall encompass all production deliverables, including those produced by subcontractors for the current period of performance. The production plan may omit the purchase of off-the-shelf ancillary reagents.

The production plan shall be submitted to the government within 150 days of contract award, approved in writing by the CO prior to implementation, and updated on at least an annual basis thereafter. The contractor shall provide CDC with written and verbal updates during weekly teleconferences regarding status, potential conflicts or changes, and upcoming due dates for any seed stocks or other requirements needed to complete the work on schedule.

8. Within 150 days of contract award, the contractor shall establish an acquisition plan

(including a supply chain management plan) and an inventory management plan to encompass all reagents produced or procured under the contract and included in the RISER catalog. The contractor’s acquisition and inventory management plans shall be submitted to the COR and CO for review within 150 days of contract award, approved in writing by the CO prior to implementation, and updated on at least an annual basis. The contractor shall also establish an acquisition plan that allows for surges at 25%, 50% and 75% above base level.

9. Within 150 days of contract award, the contractor shall establish contingency plans to guarantee process flow including but not limited to production and distribution of RISER reagents. The contingency plan shall encompass any production deliverables produced by subcontractors for the current period of performance. The contingency plans shall be submitted to the government for review and approval. The plans will be approved in writing by the CO prior to implementation, and updated on at least an annual basis thereafter, as needed.

10. Off-the-shelf ancillary reagents shall be replenished in increments to minimize expiration of unused reagents while in storage. Contractor shall consider factors that may influence purchase quantities, including seasonality in expected usage, shelf-life, availability of the most current lots from the original manufacturer, and historical burn rates. If requested, CDC can provide historical burn rate data for ancillary reagents that were part of the CDC-IRR catalog under CDC contract 75D30119C04205.

11. The contractor shall maintain records for all pathogens, and other reference reagents maintained in inventory, which shall include, but not necessarily be limited to, the following information:

a) the source/donor of the pathogen, or reagent

b) a full description of the pathogen, or reagent, including relevant epidemiologic information and identifiers to link to genetic sequence databases;

c) category of pathogen, or reagent (e.g., not of human origin, human-derived, biohazardous, radioactive, donor assigned category for commercial use);

d) lot number and date of receipt;

e) QC information;

f) storage conditions;

g) solubility of the pathogen, or reagent (when appropriate);

h) storage location;

i) restrictions, if any, on release, disposition and use;

j) how and when dispensed; and, to whom;

k) date and time shipped; and, to whom;

l) by whom it was shipped;

m) date/time received by intended recipient and documentation from the recipient

n) viral passage number indicating substrate (e.g., M2E1), date passaged and concentration of material or agent.

12. The contractor shall establish and maintain an electronic tracking system capable of generating and reading bar-coded labels for RISER reagents. Material (software and hardware) for maintaining these records shall be provided by the contractor.

13. Unless prohibited by law, the contractor shall ensure protection against the loss of data by establishing a data mirror for files with storage outside of the main facility. The system in its entirety shall be completely documented and capable of being transferred to the CDC without interruption.

14. The contractor shall ensure the security and safety of data on all RISER reagents, information related to the use of the RISER reagents, and results from design validation activities and independent evaluation. All information regarding the evaluation of RISER reagents shall be considered “government property” and shall be maintained in accordance with applicable provisions of the contract. The COR shall be responsible for determining the level of information concerning a particular pathogen or reagent that will be made available for dissemination and to whom the information will be made available.

15. The contractor shall maintain and communicate to the government detailed real-time inventory of the complete RISER catalog, including product description and/or catalog number, seed stocks, retains, and reagents in distributable inventory, quality hold, and any other potential inventory statuses (i.e., temporarily out-of-stock). This needs to be communicated electronically to the government via a real-time messaging system (yet to be determined).

16. The contractor shall place RISER reagents in “temporarily out-of-stock” status when inventory is depleted or upon government request. The contractor shall communicate reagent status electronically to government so that the RISER website can be updated.

E. Reagent Stability and Shelf-Life Management Program

1. Contractor shall maintain a plan for stability testing of the reagents manufactured by the contractor and its subcontractors to ensure that RISER reagents retain, within specified limits and throughout its period of storage and use (i.e., its shelf-life), the same physical and functional properties and characteristics that they possessed at the time of manufacture. The stability testing plan shall be submitted to the government within 30 days of the start of each period of performance.

2. Reagents manufactured by CDC may be excluded from stability studies performed by the contractor. In lieu of testing by the RISER contractor, CDC will request that specific quantities of these reagents be retained within RISER storage under the same conditions as the distributable inventory and in accordance with Appendix B – Quality Specifications, for the duration of stability testing to be performed at CDC Headquarters, Atlanta, GA.

3. In the event the contractor performs this activity, the contractor shall provide all data related to stability testing to CDC for review.

F. Manage Laboratory Registration for RISER Account

1. As of December 2023, the CDC-IRR has approximately 1500 registrants representing a global network of 971 laboratories in 193 countries, including 472 laboratories in 50 states and 6 US territories. User Agreements (UAs) are in place, between the current CDC-IRR contractor and each organization authorized to request reagents, under the terms and conditions of the current CDC-IRR contract. As part of the transition process, the contractor shall be required to establish UAs with all currently authorized users and any new organization that may wish to request RISER contract reagents in the future. UAs must be signed by a duly authorized representative of the new contractor and a duly authorized representative of the requesting activity and approved by the government; see Appendix C.

2. The UA shall clarify the transfer and use of RISER reagents after receipt by requesting organizations. The document shall define the duties of the recipients and their institutions, including the responsibility to properly handle, use, and dispose of the materials according to applicable laws and regulations and restrictions. The UA also protects the rights of all parties involved in the exchange of biomaterials from the original depositor of the material to the end-user, including indemnification of the US Government and the RISER contractor, their suppliers, and contributors from any claims, costs, damages, or expenses arising out of, or related to RISER.

3. The contractor shall review all submitted registration paperwork for completeness and accuracy. Contractor will notify registrant regarding any omissions or items needing additional clarification and assist registrant as necessary to complete. Once all registration paperwork has been confirmed as complete, contractor shall establish an account profile including an account number, shipping address, and BSL level.

4. The contractor shall submit all completed registration paperwork electronically to CDC for

COR review and approval. CDC will assign website level access to all registered laboratories and return signed documentation to the contractor for account activation.

5. The contractor shall notify registered laboratories regarding account activation, triage request for level upgrades or changes in shipment addresses, and other similar account related activities.

6. The contractor shall establish archival systems to ensure that all registration records including completed UAs are kept and accessible and electronic copies are stored off-site.

7. The contractor shall maintain up-to-date records on all RISER registrants including changes in addresses reported by the laboratory.

G. Assist with the Operation and Maintenance of the RISER Reagent Order Processing System

1. Unless otherwise requested by the government, the contractor shall submit all registrant and reagent data collected into CDC’s Reagent Order Processing System, which is based on Microsoft Dynamics 365, and hosted on CDC servers. The contractor shall assist with the operation and maintenance of this order processing system by tracking order submissions including reagent catalog number, description, quantity requested, and any justification provided by the RISER registrant into the Order Processing System. The contractor must also check that approvals including quantity and comments are received back by the contractor for packaging and shipment. The contractor must also submit all data associated with the distribution logistics into the CDC Order Processing System including status, sales order numbers, reagent lot numbers, shipment dates, requests for intermediary consignees, intermediary consignee information, requests for door-to-door deliveries, and changes to RISER registrant accounts. The RISER Reagent Order Processing System also centralizes RISER registrant account information, tracks website level access, manages allowances for products on a per order and annual basis, and facilitates communication related to RISER orders among internal users.

2. RISER Reagent Order Processing System will be housed in a CDC-hosted Microsoft

Dynamics enterprise system, which integrates with MS Office Suite, including MS Outlook and MS SharePoint. Currently, the CDC-IRR Reagent Order Processing System communicates with the CDC-IRR website via a Secure File Transfer Protocol (SFTP) maintained by CDC. However, the communication will occur with a real-time messaging system (yet to be determined).

3. Due to the level of collaboration required between the contractor and various CDC programs/offices related to information technology systems, the government anticipates that the contractor shall have at least one staff member assigned to CDC Atlanta Headquarters full time to support daily operations, as well as documentation associated with EPLC processes and requirements.

H. Receive Reagent Orders and Manage Shipping Logistics

1. The contractor shall develop an SOP to receive, acknowledge and process requests for RISER reagents from requestors as set forth below, and the SOP shall be approved in writing by the COR prior to implementation. All requests for RISER reagents and their quantities shall be approved by the COR or RISER delegated point of contact, for shipment and delivery to qualified recipients only.

2. Contractor shall establish a customer service team to communicate order status to recipient laboratories, manage shipping logistics, track order and shipment status, notify recipient laboratories of delays or product recalls, and respond to customer inquiries. Customer service representatives shall communicate with recipient laboratories via standardized response templates approved by the COR whenever possible to ensure consistent communications on topics with high frequency and/or sensitivity.

The contractor shall electronically submit all data related to product distribution into CDC’s Reagent Order Processing System, including but not limited to shipping failures that result in recipient laboratories having to perform reagent validation tests. If laboratories end up having to perform reagent validation tests, this information must be communicated immediately to the COR and RISER Management Team.

3. Customer service shall notify recipient laboratory of order approvals or denials, as well as any increases/decreases in order quantities made by the COR, within two business days of receipt of order approval. Customer service shall also notify CDC of any customer-initiated changes to already approved orders (e.g. removing or reducing an approved item) so that all related databases can be updated appropriately. Customer service may not increase a quantity or substitute a reagent without approval from the COR.

4. The contractor shall retain the following written documentation in support of each order:

a) a copy of the COR’s authorization for shipment

b) record of shipment

c) confirmation of courier delivery and/or receipt by intended recipient

d) copies of any required permits, supporting documentation, etc.

e) record of any problems experienced, delays, etc.

In addition, a formal shipping/receipt log shall be maintained to document the date that each of the above actions occurred. Contractor should have this information available electronically for any contract resolution issues that would require evaluation by the government.

5. Contractor shall notify the COR of any problems that might delay shipment, steps being taken to mitigate the extent of delays, and the target date for shipment. Contractor shall also notify COR of any shipments that are still pending shipment more than nine days after the order was approved. Notifications shall be provided to CDC as both written and verbal updates during weekly teleconferences and in a weekly backlog report.

6. The contractor shall ensure that shipping is performed in compliance with all international, federal, state and local laws and regulations for safe-handling and shipment of non-infectious and infectious materials. The contractor shall utilize shipping containers for reagents that fully comply with current domestic and international transport regulations and pertinent International Air Transport Association/International Civil Aviation Organization Dangerous Goods Regulations (IATA) IATA - Dangerous Goods Regulations (DGR)

Shipping containers must provide a sufficient margin of safety for maintaining appropriate environmental safeguards and desired temperature levels for specific products in transit, depending on the mode of transportation employed.

7. The contractor shall comply with all federal, state and local regulations governing access, distribution within a facility, shipment to other facilities, transport, and use of CDC and/or U.S. Department of Agriculture (USDA) Select Agents Select Agents and Toxins List | Federal Select Agent Program

8. The contractor shall establish archival systems to ensure that all permits and other documentation supporting compliance with federal, state, and local regulations governing access, transport, and use of CDC and/or USDA Select Agents are kept, and accessible and electronic copies are stored off-site.

9. The contractor shall develop instructions for use (package inserts) and other data sheets or technical resources, including product specifications (Appendix D – Product Specification Example) and Certificates of Analyses (Appendix E – Certificates of Analyses Example), to be packaged directly alongside RISER reagents or made available to recipients via the RISER website. All package inserts, product specifications, certificate of analyses and other data sheets will be reviewed and approved by the COR prior to distribution in accordance with CDC eclearance/documentum processes and requirements.

https://www.iata.org/en/publications/dgr https://www.selectagents.gov/sat/list.htm https://www.selectagents.gov/sat/list.htm

The contractor shall maintain template of package inserts, data sheets or technical resources, including product specifications, and Certificates of Analyses as well as establish archival systems of these documents for annual editing, as needed.

10. The contractor shall establish specific safety standards for the safe handling and use of specific viruses, bacteria, and reference reagents, in compliance with all federal, state, and local laws and regulations. Applicable safety standards will be documented and packaged with viruses and reference reagents provided to recipients. Safety Standards will be reviewed and approved by the COR prior to distribution.

11. The contractor shall utilize a secure package tracking and delivery system and written verification of receipt at destination shall be obtained to document that approved shipments are made to intended recipients in a timely manner. Deliveries shall be guaranteed within 96 hours of shipment and will be scheduled for delivery on Mondays through Thursdays only. If delivery is not possible within 96 hours, cold chain shall be maintained by a courier able to re-ice shipments.

Note: Certain materials may require special packaging and/or expedited shipment to ensure the integrity of materials being shipped.

12. The contractor shall obtain appropriate licenses and permits required by federal, state, and local United States and/or foreign government authorities for the safe import, storage, distribution and import/export of viruses, bacteria, and reference reagents. In addition, the contractor shall obtain all appropriate interstate, intrastate and/or foreign import/export shipping licenses and permits for transporting biohazardous materials. If shipments to overseas requestors are authorized, the contractor shall also be responsible for obtaining appropriate Export Permits for H5N1 or equivalent materials from the U.S. Department of Commerce.

13. The contractor shall coordinate all shipments to ensure that viability, biological activity or chemical integrity of viruses, bacteria, and reference reagents will not be adversely affected.

Written notification of shipment scheduling and acceptance by recipient shall be documented to ensure that shipping and receiving of frozen and refrigerated viruses and reference reagents is fully coordinated.

14. RISER reagents shall ship internationally as door-to-airport whenever possible. Approval for all door-to-door international shipments or any shipment over a $2,500 shipping & handling maximum cost threshold must be approved by the COR before release. Contractor shall request up to four quotes from available couriers for pricing comparison. If couriers take longer than a week to produce a quote, contractor may send all gathered quotes to COR for review and approval even if less than four are collected. Contractor shall inform the COR of the contractor’s efforts to request quotes from the couriers, in writing. RISER shall not ship reagents internationally until the recipient laboratory has notified customer service that they have completed the necessary customs paperwork to receive the shipment.

15. RISER customer service shall support recipient laboratories import processes by inquiring about delays and providing certificates of analyses, conformance, or quality, CDC donation letters or other similar type reagent documentation upon request.

16. Due to the level of collaboration required between the contractor and various CDC programs/offices related to coordination of shipments and customer service support, CDC anticipates that the contractor shall have at least one logistics specialist and one data management/logistics specialist assigned to CDC Atlanta Headquarters full time.

I. Emergency Response

1. In the event of a public health emergency, Appendix A - Deliverables may be adjusted via a bilateral contract modification to account for a decrease in, or in some cases, cessation of, non-essential reagent production activities so that labor resources may be reassigned to the production and distribution of emergency-related reagents.

2. During an emergency response, exchanges of data between the RISER Reagent Order Processing System and contractor may be expected to increase to a frequency as high as once every hour. Similarly, reporting of RISER production status, inventory status, reagent burn rates, pending shipments and other critical response functions may increase from a weekly a daily activity.

3. Based on prior emergency responses to the Influenza 2009 A(H1N1)pdm09 pandemic and the

2013 Influenza A(H7N9) regional outbreak in southeast Asia, it is expected that RISER activities during a public health emergency may involve ramped-up reagent production and priority distribution of reagents to US domestic public health laboratories and Department of Defense (DoD) or international laboratory partners in the affected region(s). Support may be expanded to include other global regions as reagents and funding resources permit.

J. Outgoing Transition to New Contractor

1. It is intended that the “Resources for Improvement of Surveillance and Emergency Response” program will continue in operation beyond the performance period of this contract, including options.

2. If the incumbent contractor is not successful in competition for award of the follow-on contract, the contractor shall exert its best efforts to ensure a safe and orderly transition of services to the new contractor, with minimum disruption of services to the public. All stored biological and reagent samples, data and government furnished property will be shipped to the successor contractor as soon as practicable after award of the new contract.

3. The contractor shall include an outgoing transition plan as part of their technical proposal to include the orderly transfer of the reagent inventory to a potential new contractor. At minimum, the transition plan must include a timeline of no more than six months, a description of project phases, a plan to provide technical assistance in reestablishment of reagent ordering and distribution activities and any necessary physical and labor resources.

The contractor’s outgoing Transition Plan shall be reviewed and approved in writing by the

COR.

4. The contractor’s outgoing Transition Plan shall be updated at least 18 months prior to contract expiration for reviewed by the COR and CO, and approved in writing by the COR.

5. Contractor transition costs will be identified in the contract as an “option” and funded by the government if appropriate.

V. DETAILED TECHNICAL OPTIONAL REQUIREMENTS

Independently and not as an agent of the government, the contractor shall provide all management, labor, facilities, materials, supplies, and equipment necessary to complete tasks as set forth below.

The goal of this optional task is to design, validate and deliver an improved workflow or scientific process for the development of assays to aid in pathogen characterization. Depending on task, the contractor may be required to conduct experiments with the primary goal of validating the new and improved platform.

The contractor shall complete all requirements specified under Milestones 1 and 2.

1. Milestone 1: Gap analysis

a. The contractor shall perform a gap analysis in the form of literature searches as well as contact technology companies and experts in the field to determine scientific knowledge gaps and evaluate existing technology that can be applied to this task. This activity will apply only to workflow, or scientific processes identified by the government as needing a gap analysis.

b. Contractor shall provide oral presentations/teleconferences with updates on the status of assigned activities at least biweekly (twice per month) or as needed.

c. Contractor shall develop a draft technical proposal for review by the COR and SME. This proposal shall be finalized upon COR approval and prior to initiating assay development.

2. Milestone 2: Assay development

a. The contractor shall seek sources needed to develop and perform assay.

b. The government will provide positive and negative controls, as needed, to the contractor as well as pathogens, to validate assay and compare its sensitivity and specificity to current platform.

c. Contractor shall perform control assays and trend analysis to monitor assay performance against current platform and submit…