RISER Sources Sought Notice.pdf

The Centers for Disease Control and Prevention (CDC) is issuing this sources sought notice as a means of conducting market research to identify parties having an interest in and the resources to support this requirement for CDC’s Resources for Improvement of Surveillance and Emergency Response (RISER). The result of this market research will contribute to determining the method of procurement. The applicable North American Industry Classification System (NAICS) code assigned to this procurement is TBD.

There is no solicitation at this time. This request for capability information does not constitute a request for proposals or quotes; submission of any information in response to this market survey is purely voluntary; the government assumes no financial responsibility for any costs incurred.

If your organization has the potential capacity to perform these contract services, please provide the following information: 1) organization name, address, email address, website address, telephone number, and size and type of ownership for the organization; and 2) tailored capability statements addressing the particulars of this effort, with appropriate documentation supporting claims of organizational and staff capability. If significant subcontracting or teaming is anticipated in order to deliver technical capability, organizations should address the administrative and management structure of such arrangements.

The government will evaluate market information to ascertain potential market capacity to 1) provide services consistent in scope and scale with those described in this notice and otherwise anticipated; 2) secure and apply the full range of corporate financial, human capital, and technical resources required to successfully perform similar requirements; 3) implement a successful project management plan that includes: compliance with program schedules; cost containment; meeting and tracking performance; hiring and retention of key personnel and risk mitigation; 4) provide services under an indefinite delivery indefinite quantity contract.

Based on the responses to this sources sought notice/market research, this requirement may be set-aside for small businesses or procured through full and open competition. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions.

Additional Market Research Questions:

1. Based on the provided information, what NAICS code would your firm consider to be the most appropriate for your firm to propose under?

2. Do you provide these services commercially?

3. In your estimation how much of this potential requirement would your company need to subcontract to other companies?

4. Please provide any feedback or questions you may have related to the draft document – optional.

Submission Instructions: Interested parties who consider themselves qualified to perform the above-listed services are invited to submit a response to this Sources Sought Notice by 5:00 PM EDT on September 17, 2024. All responses under this Sources Sought Notice must be emailed to the Contracting Officer, Jennifer Gartzke, at xuy7@cdc.gov. If you have any questions concerning this opportunity, please contact the Contracting Officer.

Attachment 1 – Draft Statement of Work mailto:xuy7@cdc.gov

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 in an effort 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 invent 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 Contract (CDC-IRR)”. 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.

II. PROJECT OBJECTIVES

The primary objectives of this contract are:

1. to produce high quality stocks of reference pathogens, positive controls, detection kits, proficiency panels and other similar type surveillance and research reagents;

2. to ensure that these reagents, and any others 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 receive and distribute data (i.e., proficiency panel results and sequencing data) submitted by public health partners to appropriate CDC laboratories for review and evaluation;

4. 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.

III. SCOPE OF WORK

The contractor will 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-born 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 task orders will vary in size ranging from $30,000 to approximately $3,000,000.

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 will 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 will be made available to registered persons and institutions through an electronic “storefront” website, to be provided by the government and maintained by the contractor (see Section IV). The “storefront” website shall also provide RISER registered persons the ability to submit laboratory data related to reagents distributed through RISER. These data include but are not limited to proficiency panel results and sequencing of pathogens. The contractor will receive and process reagent order requests from the RISER website via their internal Enterprise Resource Planning (ERP) system and manage all shipping logistics to recipient laboratories. The contractor will also receive and disseminate to government data received through the RISER website.

IV. DETAILED TECHNICAL 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. Reserved.

B. 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.

2. Draft SOPs shall be prepared for each 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 in order 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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/default.htm https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/default.htm protocols shall be required for each item and submitted to the government for approval prior to implementation in order to ensure manufacture of materials that meet or exceed the government’s inspection/acceptance criteria for that item.

4. All other contractor draft SOP’s 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 SOP’s 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.

C. Facility Requirements

1. The contractor shall provide dedicated facilities and equipment to receive, handle, propagate, aliquot, fully characterize, vial, weigh, store and ship BSL 1 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 are not 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 viruses 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 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 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.

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 of 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 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

E. Establish, Maintain, and Operate the RISER Catalog

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. 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 current 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. Off-the-shelf ancillary reagents shall be replenished in increments in order 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.

10. 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.

11. 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.

12. 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.

13. 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.

14. The contractor shall maintain detailed up-to-date inventories 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. This information shall be maintained in electronic databases and shall be reported to the COR on a daily basis.

15. The contractor shall place RISER reagents in “temporarily out-of-stock” status on the RISER website (Section F) when inventory is depleted or upon government request. The contractor shall notify RISER registrants immediately after material is replenished and back in stock.

F. 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 in order 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.

G. Operate and Maintain the RISER Website

1. The contractor shall host, operate, and maintain an electronic “storefront” at through which reagents and information concerning the “CDC’s Resources for Improvement of Surveillance and Emergency Response” will be made available to participating partners and institutions.

2. The government will provide the RISER website code based on a DotNetNuke framework, copies of SQL server derived databases (product catalog, SOLR indexes for searching and DotNetNuke for portal settings and user information) and copies of integration scripts that process or update systems connected to the RISER website (one-way, from RISER to an outside system).

3. The contractor shall be responsible for hosting and infrastructure services and support, application support, and maintaining website functionality and compatibility with the contractor’s ERP system to manage inventory, receive communications from the RISER website, and track shipment and distribution logistics. Additional requirements include:

a) the establishment, configuration, provision and maintenance of a DotNetNuke environment and “hosting” of the RISER website in its current state;

b) obtain an authority to operate the RISER website from CDC Office of the Chief Information Officer (OCISO);

c) ensure the website is maintained at a 99.90% uptime status.

d) provide an encrypted connection to the website at all times in accordance with HHS practices;

e) provide continuous monitoring of website for unauthorized access and intruder disruptions;

f) perform weekly security scans and remediate any identified issues in accordance with government timelines;

g) provide a monthly report of security scan results;

h) provide all website changes that result from security concerns as soon as possible after self-awareness or notification by government;

i) provide a process to verify/validate user identity when new accounts are requested and verify user identity before providing users with account information;

j) provide a process to update and maintain all user, product, study and shipping permit information from the contractor’s internal operations system(s). Please note that government will not allow a complete re-engineering of user, product, study and permit catalog information in order to facilitate IT integration of contractor’s internal systems with the RISER website;

k) update all government specified changes to user, catalog, study and shipping permit information within 1 business day;

l) develop a notification mechanism that will inform RISER users when a reagent back in-stock;

m) develop a notification mechanism to inform RISER users of reagent information as requested from the government, including availability of a material for ordering, expiration date extensions, etc.;

n) develop a system that allows RISER users to upload data unto the website, particularly sequencing and proficiency panel result data, and for data to be transmitted back to government for review and evaluation;

o) develop product pages that are 508 compliant for government review and approval;

p) develop batch XML feeds to provide daily updates to the existing internal RISER Reagent Order Processing System.

4. The website shall serve as an online ordering portal for requestors needing RISER pathogens, and other surveillance and research reagents listed in Appendix A – Deliverables. Reagents are divided into levels, or reagent subsets, related to their function and/or association with specific surveillance or research efforts. All RISER accounts are programmed such that registrants are only able to view the reagents in levels to which they have approved access.

5. The website will also serve as an electronic bulletin board for this contract, through which the government will publicize the purpose and intent of the project, procedures for requesting reagents, RISER-related SOPs, product specifications, certificate of analyses and other similar type documentation. It shall be the responsibility of the contractor to develop and update all materials to be published at the website subject to approval of the COR.

6. The RISER website shall export orders no later than 9 am every work day for COR review and approval. During an emergency response, more frequent export of orders may be required, e.g. every hour.

7. The RISER website will provide laboratories with an automated message acknowledging order receipt and providing a traceable order number. This message is not an indication of CDC approval of the final items or quantities in the shopping cart; rather, it is an acknowledgement that an order has been received for further processing.

8. The RISER website will provide a link to the terms and conditions of the World Health

Organization’s Standard Material Transfer Agreement 2 (SMTA 2) for acknowledgement by any RISER registrant who has requested a reagent that meets the definition of Pandemic Influenza Potential Biological Material (PIPBM). WHO: PIP Framework – Standard Material Transfer Agreement 2 (SMTA 2) The website shall send an automated message documenting this acknowledgment to the COR and the contractor shall assist with any required documentation associated with these requests.

9. Contractor shall troubleshoot any website errors, implement software patches and updates, and perform other general maintenance activities in order to ensure continued operations.

10. The contractor shall collaborate with the COR to identify innovative ways to enhance dissemination of information relating to products and services available through the contract to target audiences. This may involve selective publication in scientific journals, publications, newsletters, etc., developing posters, staffing booths and making presentations at scientific conferences, meetings, workshops, etc.

11. The contractor shall establish and maintain a published “hotline” phone number through which current and potential RISER registrants can contact a live operator during normal business hours to obtain information on available reagents, discuss issues regarding pending orders, inquire about shipment scheduling, etc. After hours callers shall be invited to leave a voicemail message for return by 12:00 noon the following workday.

12. The time, cost, and scope of any development, modernization, and enhancements projects to support the RISER website shall be reviewed and approved by the COR in advance. The contractor shall utilize Enterprise Performance Life Cycle (EPLC) methodology to plan, manage and oversee these projects in accordance with HHS policy, Policy for Information Technology (IT) Enterprise Performance | HHS.gov, and shall contribute to the preparation and submission of documentation to support CDC’s stage gate reviews as needed. The contractor shall also contribute data to support reporting of monthly project cost and scheduling.

https://www.who.int/multi-media/details/who-pip-framework---standard-material-transfer-agreement-2-(smta-2) https://www.who.int/multi-media/details/who-pip-framework---standard-material-transfer-agreement-2-(smta-2) https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/policy-for-information-technology-enterprise-performance.html https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/policy-for-information-technology-enterprise-performance.html

13. Contractor shall contribute to the preparation and submission of ongoing security milestones for the RISER website, including annual security self-assessments, business continuity plan (BCP) tests, and privacy impact assessments (PIAs). The contractor shall also prepare a HHS VPAT and other documentation to report Section 508 compliance each year (see HHSAR provision 352.239-73 in section K).

H. Manage Laboratory Registration for RISER Account

1. RISER is intended for domestic and international distribution of pathogens and reagents. To order reagents from the RISER, all laboratories must register to establish an account, have a RISER website login name, have a RISER website password, and a multifactor authentication process per HHS guidelines. Health Sector Cybersecurity Coordination Center (HC3) | HHS.gov

2. 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.

3. The UA shall clarify the transfer and use of RISER reagents subsequent to 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.

4. 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 provide assistance 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.

5. The contractor shall submit all completed registration paperwork 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.

6. The contractor shall notify registered laboratories regarding account activation, assist in the establishment or retrieval of forgotten passwords, triage requests for level upgrades or changes in shipment addresses, and other similar account related activities.

7. 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.

8. The contractor shall maintain up-to-date records on all RISER registrants including changes in addresses reported by the laboratory. Unless otherwise requested by the government, the contractor shall review RISER log-in attempts and “deactive” those accounts with no log-in attempts over a period of two years. The contractor shall develop a batch XML to provide these updates to the existing internal RISER Reagent Order Processing System.

https://www.hhs.gov/about/agencies/asa/ocio/hc3/index.html https://www.hhs.gov/about/agencies/asa/ocio/hc3/index.html

I. 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 by the website 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. Additional data exchanges between the website and the RISER Reagent Order Processing System transmit additional order details from the contractor’s ERP systems, including sales order numbers, reagent lot numbers, shipment dates, requests for intermediary consignees, intermediary consignee information, 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. A Mirth messaging engine may be available at a later date.

3. The RISER Reagent Order Processing System shall receive orders from the RISER website by 9 am every workday for COR review and approval, and then return released orders to the contractor by no later than 4:30 each work day.

4. Contractor shall maintain compatibility of the RISER website with the RISER Reagent Order

Processing System to enable data exchanges.

5. Contractor shall troubleshoot system errors and coordinate with CDC’s Information Technology Services Office team supporting MS Dynamics, Microsoft Tech Support, and other entities as necessary to implement software patches and updates and perform other general maintenance activities in order to ensure continued operations.

6. The time, cost and scope of any development, modernization, and enhancements projects to support the RISER Reagent Order Processing System shall be reviewed and approved by the COR in advance. The contractor shall utilize EPLC methodology to plan, manage and oversee these projects in accordance with HHS policy, Policy for Information Technology (IT) Enterprise Performance | HHS.gov , and shall contribute to the preparation and submission of documentation to support CDC’s stage gate reviews as needed. The contractor shall also contribute data to support reporting of monthly project cost and scheduling.

7. 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 of the RISER website and the RISER Reagent Order Processing System, as well as documentation associated with EPLC processes and requirements.

J. 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 https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/policy-for-information-technology-enterprise-performance.html https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/policy-for-information-technology-enterprise-performance.html 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 in order to ensure consistent communications on topics with high frequency and/or sensitivity.

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 2 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 will 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 will 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 (9) 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 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 https://www.iata.org/en/publications/dgr https://www.selectagents.gov/sat/list.htm

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.

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…