JA.pdf

Template for Justification and Approval for Other Than Full and Open Competition Completion Instructions: The Department of Health and Human Services (HHS) has established a standard template for the preparation of a J&A for Other Than Full and Open Competition. If this is an 8(a) set-aside, please note this form is not required unless the acquisition is valued (including all options) at greater than $22 million. This template is NOT applicable for actions using simplified acquisition procedures (FAR Part 13), Federal Supply Schedule orders (FAR 8.4) or task or delivery orders subject to fair opportunity (FAR 16.505).

Tailor all aspects of this template to the individual acquisition. Consult FAR Subpart 6.3 for guidance. An addendum may be added in case additional space is needed.

When this document is printed, the blue italic instructions are automatically deleted on the printed version.

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

Acquisition Title: Contract 75D30120C08150 Modification COVID-19 Cohort Studies

Agency: CDC

Acquisition Year (FY): 22

Author and Title: Mark Thompson (isq8), Mary Hoelscher Gonzalez (mzr1)

2. Description of Action:

Nature: New Requirement Follow-on Requirement

Modification to Existing Purchase Order/Contract Number: 200-2020-08150

Pricing: Firm-Fixed Price Time & Materials Cost

Other:

Funds: OMA Other Funds:

Name of Proposed Contractor(s): Abt Associates

Street Address: 2200 Century Parkway, Suite 950

City, State, Zip: Atlanta, GA 30345

3. Description of Services or Supplies:

Basis for Approval (FAR 6.303-1(d)): Individual Basis Class Basis

The total estimated value of the proposed action, including all options is $ 26,000,000

As applicable, briefly describe the services or supplies required to meet the agency's needs, including make & model number where appropriate. Include quantities of supplies or period of performance for services. Provide information for any options included. If the action is a modification to an existing contract, distinguish clearly between the work covered by the original contract and the work to be obtained by the proposed modification.

Contract 75D30120C08150 “COVID-19 Pandemic Cohorts” funds activities to evaluate the effectiveness of COVID-19 vaccines among essential workers through a project named RECOVER (Research on the Epidemiology of SARS-CoV-2 in Essential Response Personnel). Over 4,000 participants are currently enrolled in a RECOVER cohort in Florida (Miami), Minnesota (Duluth), Oregon (Portland), Texas (Temple), and Utah (Salt Lake City). The contractor and sub-contracted partner organizations conduct multiple research activities, including surveillance for COVID-19 and routine weekly testing for SARS-CoV-2 infection by molecular assays.

Electronic surveys are completed at the start and end of any illness. Vaccination is determined by self-report and verified through review of vaccination cards, electronic medical records, or state registries. Participants contribute sera every 3 months. After completing data quality control review, the contractor delivers data to CDC bi-weekly.

Modification to this contract would include changes in three tasks and the period of performance: (1) examine the preventive benefit of a fourth and possibly additional COVID-19 vaccine doses and compare risks of infection between those who are up-to-date on recommendation vaccination versus those who are unvaccinated and those who have not received recommended doses;

(2) compare the preventive benefit of vaccines against the Omicron variant and any subsequent variants of concern compared to earlier Wild Type and Delta variants; (3) complete all molecular and virologic laboratory assays as part of contract activities.

Previously CDC has supplemented laboratory testing but will no longer be able to do so.

Finally, because recommended vaccination regimen has changed recently and is expected to change further and because new SARS-CoV-2 variants have emerged, CDC requires that the contractor extend the study activities an additional study year. This will require the contractor to conduct active surveillance, routine SARS-CoV-2 testing, period sera collection, and all other cohort activities through April 30, 2023. Allowing for data finalization and close out activities, the period of performance would need to conclude on September 30 2023 instead of 24 April 2022.

4. Authority and Rationale: Identify the statutory authority, FAR title and FAR citation permitting other than full and open competition. It may be one of the following most commonly used citations by the operating divisions of the Department of Health and Human Services (HHS), but other exceptions may apply per FAR Subpart 6.3.

Actions other than simplified acquisition procedures (select only one and provide an explanation):

FAR 6.302-1: Only one responsible source and no other supplies or services will satisfy agency requirements, 41 U.S.C.

3304(a)(1)

Explain why the intended contractor is the only responsible source who can provide the required supplies or services.

Discuss the unique capabilities, expertise, etc. that support the lack of competition/why no other type of supplies or services will satisfy agency requirements. Explain factors/unique qualifications such as proprietary data or exclusive licensing rights, if applicable. When competition is limited to items particular to one manufacturer, this justification must explain why the particular brand name, product, or feature is essential to the Government's requirements, and that market research indicates other companies' similar products, or products lacking the particular feature, do not meet, or cannot be modified to meet the agency's needs in accordance with FAR 11.105. If in connection with a follow-on contract for continued development or production of highly specialized equipment, detail the substantial duplication of cost or unacceptable delays. May not Exceed one year, including all options, unless the head of the agency (Secretary of HHS) determines that exceptional circumstances apply.

Contract 75D30120C08150 “COVID-19 Pandemic Cohorts” was issued in response to a competitive Broad Agency Announcement the CDC issued in FY2020. All interested and qualified contractors were invited to propose BAA research projects to meet the CDC's identified topical needs. The Contractor's approach for this effort to investigate the trajectory of COVID-19 and effectiveness of COVID-19 vaccines received BAA award because the Contractor utilizes innovative solutions to modify its existing protocols, procedures, and institutional review board (IRB) documentation to create a large prospective cohort study in a timely way given urgent CDC needs for data during the COVID-19 pandemic.

This study, unique to the Contractor, presents a novel solution and design to the BAA topic for which it was submitted. CDC selected the Contractor’s research proposal for award and as a result issued Contract 75D30120C08150. This study began in April 2020 and has successfully completed tasks described in Section 3, above.

Because Abt Associates has completed all study activities to date, manages subcontracts with existing study sites, and has established systems to conduct all required evaluations, Abt Associates is uniquely qualified to address CDC's expanded tasks and period of evaluation and is the only responsible source who can supply these services. First, because Abt Associates currently operates a large prospective cohort of over 4,000 participants they are able to extend these activities and address CDC’s needs in an efficient and effective manner. This collaboration and their use of common surveillance and laboratory methods ensures that CDC is able to compare and combine results across cohorts in a valid, reliable, and timely manner. A different contractor would not be able to implement a cohort study of this size using a common methodology which would jeopardize the scientific validity and reliability of the data CDC receives and has received to date. It is essential that the new required information be added to this network in a way that is comparable and collapsible with the existing study results to date. CDC has not found alternative capability to date, but should a hypothetical alternative capability existing, this new contractor would require at least 6 months from contract award to establishing a new cohort of this size, while in contrast the existing Contractor could ramp up seamlessly. Second, this effort to date has included conducting special investigations of key knowledge gaps and partnering with CDC to update CDC, White House Leadership, and the Advisory Committee of Immunization Policy (ACIP) in a timely manner and publish results in various medical journals. This partnership has been built on over 18 months of existing work and reporting thereby having established reliability and public trust in the output. A new Contractor would require a similar amount of time to gain this experience and public trust in the output of investigation results. Additionally, there would be a lapse in investigative coverage by switching Contractors at this point which would impede on data gathering, analysis, and collaboration amongst study partners and overall investigative output cadence and rigor. Third, given the unprecedented urgency and time pressure for study findings, delays in identifying and launching a new contractor would risk delaying CDC's ability to make evidence-based policy decision and in turn potentially jeopardize public health and safety.

FAR 6.302-2: Unusual and compelling urgency, 41 U.S.C. 3304(a)(2) If unusual and compelling urgency is the basis for the justification, explain the chronological events leading up to the requirement and explain why time constraints cannot permit even a limited competition. Describe the detrimental effects/ serious injury to the mission of the requiring activity or to the government, financial or otherwise, that will result if this justification is not approved. Describe impact of required delivery/performance date. Describe the detrimental effects/serious injury to the mission of the requiring activity or to the government, financial or otherwise, that will result if this justification is not approved and the product or service cannot be provided by the intended sole source contractor. Failure to plan for expiring funds is not a valid reason for citing this exception. May not exceed one year, including all options, unless the head of the agency determines that exceptional circumstances apply.

FAR 6.302-5: Authorized or Required by Statute, 41 U.S.C. 3304(a)(5) Provide a citation to the statutory authorization and a brief description of its content, or identify the specified source or other agency.

Other (See FAR Subpart 6.3 for additional authority) Provide the authority and citation to the applicable section of FAR 6.3.

Provide a full explanation to justify use of the exception.

5. Agency Actions to Take or Remove Barriers That Led to Other Than Full and Open Competition (If applicable):

Describe the actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration prior to any subsequent acquisition for the supplies of services is made. If no such actions have been taken, explain why.

Abt Associates is the only contractor able to restructure and adapt their existing cohorts to meet CDC's needs. It is essential that there be continuity in methodology across cohorts and consistent procedures that Abt Associates has already established. Given core research activities are already implemented through Abt Associates and its network of partners, it would not be possible for another vendor to enter the project at this time.

6. Bridge Contracts:

For contract extensions or bridge contracts when a competitive follow-on is in the process of being developed, summarize history of current contract and explain the reasons for any delays in the acquisition. Include discussion of the milestones for the follow-on action; the milestones should be as efficient as possible. Discuss why it would be neither cost effective nor realistic to expect another contractor to perform during the brief interim period; include issues such as start-up costs, phase-in, transfer of GFP, recruitment and staffing, etc. If the action is because of a protest, provide a brief discussion of the protest including the date the protest was filed and the basis of the protest. Explain that the action will provide the minimum quantity or performance period.

Not applicable as there is not an anticipated bridge contract contemplated.

7. Actions to Increase Competition:

Describe efforts made to compete the action, including whether a notice was or will be publicized as required by FAR Subpart

5.2 or which exception under FAR 5.202 applies. If a notice was publicized, discuss the number of written responses to the synopsis and the results of the assessment of the written responses. List sources, if any, that expressed, in writing, an interest in the acquisition. Provide rationale if interested sources were rejected. If applicable, state that no other sources have expressed interest, but all offers received shall be considered. Describe what actions will be taken to increase competition before subsequent acquisition of the supplies or services is required. You may state that an action is a one-time requirement, but if a similar requirement arises, every effort will be made to compete it to the maximum extent possible. If action is sole source because of proprietary data or licensing rights and there will be a continuing need for the requirement, there must be evidence that advanced planning has been initiated to overcome the barriers to competition, or there should be documentation to support an analysis that replacement costs/licensing purchase costs outweigh the benefits of competition.

If the action is a contract extension or bridge, explain actions to compete the follow-on. If action is an urgent new requirement and a competitive follow-on is anticipated, explain that efforts are underway to facilitate a full and open competition.

A notice was published as required by FAR Subpart 5.2 and no alternative sources responded.

8. Market Research:

Describe the extent of the market research conducted to identify all qualified sources and the results thereof. “Market Research” is defined as those attempts you made to ascertain whether other qualified sources exist, and can include contact with knowledgeable experts regarding similar or duplicate requirements, contact with industry, results of a sources sought synopsis, or draft solicitations. Research of the marketplace may consist of written, electronic (i.e. email) telephonic, or world wide web inquiries. Lack of advanced planning is not an acceptable reason for the lack of market research, but true urgency may necessitate abbreviated market research that is limited to readily available historical and commercial information. If action is a contract extension or bridge contract, describe the market research efforts underway or completed for the follow-

on. See FAR 10.002(b)(2).

The networks and infrastructure developed by Abt Associates to perform prospective cohort studies on the risk and disease epidemiology of COVID -19 and other co-circulating respiratory pathogens among US population groups is entirely unique within the United States at this time. All reviews of the scientific literature and outreach by CDC subject matter experts to professionals peers and leading researchers around the world in this area show that no other entity is performing similar work in the US or able to stand up the infrastructure needed to complete the current requirements within the time frame demanded by the ongoing COVID-19 pandemic.

9. Procurement History:

Purchase order or contract number: 200-2020-08150

Was action competed? Yes No

If action was not competed, state the cited authority, summarize rationale, and describe the actions that were supposed to be taken to increase competition and the results thereof:

10. Additional Information to support the justification:

If applicable, explain why technical packages or specifications to facilitate competition were not developed or available;

describe actions taken to remedy the situation.

Not modifying the current contract would represent a loss of critical time to the agency in addressing CDC's urgent COVID-19 pandemic activities. It would take 285 days or ~9.5 months to issue a new contract and begin a new study on these objectives. [~9.5 months is derived from approximately 120 days to develop and clear the requirement to the PR stage (ITDG project concept review, funding proposal approval, requirement development, clearance and signature), and then OAS would have 165 days to contract.] In addition to the ~9.5 months to award, a new contractor would require at least 6 months for a similar study design to reach the current level of research. Starting a new research study would thus cost the government 15.5 months, during which time the modified research study would have been completed. This time delay in receiving critical COVID-19 research answers is unacceptable for scientific research that CDC needs as soon as possible for its COVID-19 pandemic response.

The impact to American lives affected or lost due to unacceptable delays to rebuild a similar study are inestimable. The research from this contract is critically needed to help CDC understand how to align national public health policies to minimize the continued loss of life and compromised health for Americans.

11. Technical / Requirements Certification: By my signature below, I certify that the supporting data included in this J&A is accurate and complete.

Program Manager

Name: Mary Hoelscher Gonzalez

Position Title: Health Scientist, COR

Email address: mzr1@cdc.gov

Phone: (404) 639-5446

Program Manager Supervisor (or one level above Program Manager)

Name: Eric Gogstad

Position Title: Associate Director of Program Management

Email address: elg5@cdc.gov

Signature:

Date: Feb 14, 2022

12. Fair and Reasonable Price/Cost Determination: As Contracting Officer, by my signature below, I hereby determine that the anticipated price/cost to the Government for this contract action will be fair and reasonable.

Provide the basis for this determination, e.g., describe techniques to be used to determine fair and reasonable price (FAR Subpart 15.402), such as price analysis, cost analysis, cost realism. Per FAR Subpart 15.403-4(a)(1), the threshold for obtaining cost or pricing data is $750,000.

All pricing will be evaluated to determine if the pricing is fair and reasonable. For some pricing elements, the contractor will provide quotes and those quotes will be evaluated and compared to current market prices. In addition, for labor rates, the proposed labor rates will be compared to the current labor rates in the existing contract and will also be compared to GSA labor rates.

Name: Christina McMichael Phone: 770-488-2697

Signature: Date: 2/25/2022

13. Contracting Officer's Approval (Required for proposed contract not to exceed $700,000 (value calculated including all options)): I hereby certify that this justification is accurate and complete to the best of my knowledge. I approve this justification subject to availability of funds, and provided that the services and supplies herin describe have otherwise been authorized for acquisition.

Name: Phone:

Signature: Date:

14. Legal Review:

All J&As greater than $68 million must have a legal review from the General Law Division of the Office of the General Counsel prior to sending it to the Department.

15. OPDIV Competition Advocate Approval (Required for proposed contract over $700,000 but not exceeding $13.5 million value calculated including all options)):

I have reviewed this justification and find that it adequately supports other than full and open competition.

Name: Sherry Smallwood Phone: 404-639-7291

Signature: Date: Apr 6, 2022

16. Office of Small and Disadvantaged Business Utilization:

I have reviewed this justification and find that it adequately supports other than full and open competition.

Name: Phone:

Signature: Date:

17. OPDIV HCA Approval (Required for proposed contract over $13.5 million but not exceeding $68 million value calculated including all options)):

Name: Julio E Lopez Phone:

Signature: Date:

18. Department Competition Advocate:

Concur: Non-Concur:

Name: Phone:

Signature: Date:

(The below approval paragraph is required if the cumulative contract value, including all options, exceeds $68 million.)

19. HHS Senior Procurement Executive (SPE) Approval:

Based on the foregoing justification, I hereby approve other than full and open competition for the above stated procurement, subject to the availability of funds, and provided that the services herein described have otherwise been authorized for acquisition.

State supplies/services being procured:

State the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 3304:

Name: Phone:

Signature: Date:

Template for Justification and Approval for Other Than Full and Open Competition Completion Instructions: The Department of Health and Human Services (HHS) has established a standard template for the preparation of a J&A for Other Than Full and Open Competition. If this is an 8(a) set-aside, please note this form is not required unless the acquisition is valued (including all options) at greater than $22 million. This template is NOT applicable for actions using simplified acquisition procedures (FAR Part 13), Federal Supply Schedule orders (FAR 8.4) or task or delivery orders subject to fair opportunity (FAR 16.505).

Tailor all aspects of this template to the individual acquisition. Consult FAR Subpart 6.3 for guidance. An addendum may be added in case additional space is needed.

When this document is printed, the blue italic instructions are automatically deleted on the printed version.

JUSTIFICATION AND APPROVAL FOR OTHER THAN FULL AND OPEN COMPETITION

2. Description of Action:

Nature:

Pricing:

Funds:

3. Description of Services or Supplies:

Basis for Approval (FAR 6.303-1(d)):

As applicable, briefly describe the services or supplies required to meet the agency's needs, including make & model number where appropriate. Include quantities of supplies or period of performance for services. Provide information for any options included. If the action is a modification to an existing contract, distinguish clearly between the work covered by the original contract and the work to be obtained by the proposed modification.

4. Authority and Rationale: Identify the statutory authority, FAR title and FAR citation permitting other than full and open competition. It may be one of the following most commonly used citations by the operating divisions of the Department of Health and Human Services (HHS), but other exceptions may apply per FAR Subpart 6.3.

Actions other than simplified acquisition procedures (select only one and provide an explanation):

Explain why the intended contractor is the only responsible source who can provide the required supplies or services. Discuss the unique capabilities, expertise, etc. that support the lack of competition/why no other type of supplies or services will satisfy agency requirements. Explain factors/unique qualifications such as proprietary data or exclusive licensing rights, if applicable. When competition is limited to items particular to one manufacturer, this justification must explain why the particular brand name, product, or feature is essential to the Government's requirements, and that market research indicates other companies' similar products, or products lacking the particular feature, do not meet, or cannot be modified to meet the agency's needs in accordance with FAR 11.105. If in connection with a follow-on contract for continued development or production of highly specialized equipment, detail the substantial duplication of cost or unacceptable delays. May not Exceed one year, including all options, unless the head of the agency (Secretary of HHS) determines that exceptional circumstances apply.

If unusual and compelling urgency is the basis for the justification, explain the chronological events leading up to the requirement and explain why time constraints cannot permit even a limited competition. Describe the detrimental effects/serious injury to the mission of the requiring activity or to the government, financial or otherwise, that will result if this justification is not approved. Describe impact of required delivery/performance date. Describe the detrimental effects/serious injury to the mission of the requiring activity or to the government, financial or otherwise, that will result if this justification is not approved and the product or service cannot be provided by the intended sole source contractor. Failure to plan for expiring funds is not a valid reason for citing this exception. May not exceed one year, including all options, unless the head of the agency determines that exceptional circumstances apply.

Provide a citation to the statutory authorization and a brief description of its content, or identify the specified source or other agency.

Provide the authority and citation to the applicable section of FAR 6.3.

Provide a full explanation to justify use of the exception.

5. Agency Actions to Take or Remove Barriers That Led to Other Than Full and Open Competition (If applicable):

Describe the actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration prior to any subsequent acquisition for the supplies of services is made. If no such actions have been taken, explain why.

6. Bridge Contracts:

For contract extensions or bridge contracts when a competitive follow-on is in the process of being developed, summarize history of current contract and explain the reasons for any delays in the acquisition. Include discussion of the milestones for the follow-on action; the milestones should be as efficient as possible. Discuss why it would be neither cost effective nor realistic to expect another contractor to perform during the brief interim period; include issues such as start-up costs, phase-in, transfer of GFP, recruitment and staffing, etc. If the action is because of a protest, provide a brief discussion of the protest including the date the protest was filed and the basis of the protest. Explain that the action will provide the minimum quantity or performance period.

7. Actions to Increase Competition:

Describe efforts made to compete the action, including whether a notice was or will be publicized as required by FAR Subpart 5.2 or which exception under FAR 5.202 applies. If a notice was publicized, discuss the number of written responses to the synopsis and the results of the assessment of the written responses. List sources, if any, that expressed, in writing, an interest in the acquisition. Provide rationale if interested sources were rejected. If applicable, state that no other sources have expressed interest, but all offers received shall be considered. Describe what actions will be taken to increase competition before subsequent acquisition of the supplies or services is required. You may state that an action is a one-time requirement, but if a similar requirement arises, every effort will be made to compete it to the maximum extent possible. If action is sole source because of proprietary data or licensing rights and there will be a continuing need for the requirement, there must be evidence that advanced planning has been initiated to overcome the barriers to competition, or there should be documentation to support an analysis that replacement costs/licensing purchase costs outweigh the benefits of competition. If the action is a contract extension or bridge, explain actions to compete the follow-on. If action is an urgent new requirement and a competitive follow-on is anticipated, explain that efforts are underway to facilitate a full and open competition.

8. Market Research:

Describe the extent of the market research conducted to identify all qualified sources and the results thereof. “Market Research” is defined as those attempts you made to ascertain whether other qualified sources exist, and can include contact with knowledgeable experts regarding similar or duplicate requirements, contact with industry, results of a sources sought synopsis, or draft solicitations. Research of the marketplace may consist of written, electronic (i.e. email) telephonic, or world wide web inquiries. Lack of advanced planning is not an acceptable reason for the lack of market research, but true urgency may necessitate abbreviated market research that is limited to readily available historical and commercial information. If action is a contract extension or bridge contract, describe the market research efforts underway or completed for the follow-on. See FAR 10.002(b)(2).

9. Procurement History:

Was action competed?

If action was not competed, state the cited authority, summarize rationale, and describe the actions that were supposed to be taken to increase competition and the results thereof:

10. Additional Information to support the justification:

If applicable, explain why technical packages or specifications to facilitate competition were not developed or available; describe actions taken to remedy the situation.

11. Technical / Requirements Certification: By my signature below, I certify that the supporting data included in this J&A is accurate and complete.

Program Manager Name:

Position Title:

Email address:

Phone:

Program Manager Supervisor (or one level above Program Manager) Name:

Position Title:

Email address:

Signature:

Date:

12. Fair and Reasonable Price/Cost Determination: As Contracting Officer, by my signature below, I hereby determine that the anticipated price/cost to the Government for this contract action will be fair and reasonable.

Provide the basis for this determination, e.g., describe techniques to be used to determine fair and reasonable price (FAR Subpart 15.402), such as price analysis, cost analysis, cost realism. Per FAR Subpart 15.403-4(a)(1), the threshold for obtaining cost or pricing data is $750,000.

Name:

Phone:

Signature:

Date:

13. Contracting Officer's Approval (Required for proposed contract not to exceed $700,000 (value calculated including all options)): I hereby certify that this justification is accurate and complete to the best of my knowledge. I approve this justification subject to availability of funds, and provided that the services and supplies herin describe have otherwise been authorized for acquisition.

Name:

Phone:

Signature:

Date:

14. Legal Review:

All J&As greater than $68 million must have a legal review from the General Law Division of the Office of the General Counsel prior to sending it to the Department.

15. OPDIV Competition Advocate Approval (Required for proposed contract over $700,000 but not exceeding $13.5 million value calculated including all options)):

I have reviewed this justification and find that it adequately supports other than full and open competition.

Name:

Phone:

Signature:

Date:

16. Office of Small and Disadvantaged Business Utilization:

I have reviewed this justification and find that it adequately supports other than full and open competition.

Name:

Phone:

Signature:

Date:

17. OPDIV HCA Approval (Required for proposed contract over $13.5 million but not exceeding $68 million value calculated including all options)):

Name:

Phone:

Signature:

Date:

18. Department Competition Advocate:

Concur:

Non-Concur:

Name:

Phone:

Signature:

Date:

(The below approval paragraph is required if the cumulative contract value, including all options, exceeds $68 million.)

19. HHS Senior Procurement Executive (SPE) Approval:

Based on the foregoing justification, I hereby approve other than full and open competition for the above stated procurement, subject to the availability of funds, and provided that the services herein described have otherwise been authorized for acquisition.

State supplies/services being procured:

State the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 3304:

State the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 3304 Name:

Phone:

Signature:

Date:

11.0.0.20130303.1.892433.887364 Justification & Approval - Other Than Full and Open Competition Health and Human Services Justification & Approval - Other Than Full and Open Competition

Modification to this contract would include changes in three tasks and the period of performance: (1) examine the preventive benefit of a fourth and possibly additional COVID-19 vaccine doses and compare risks of infection between those who are up-to-date on recommendation vaccination versus those who are unvaccinated and those who have not received recommended doses; (2) compare the preventive benefit of vaccines against the Omicron variant and any subsequent variants of concern compared to earlier Wild Type and Delta variants; (3) complete all molecular and virologic laboratory assays as part of contract activities. Previously CDC has supplemented laboratory testing but will no longer be able to do so.

Finally, because recommended vaccination regimen has changed recently and is expected to change further and because new SARS-CoV-2 variants have emerged, CDC requires that the contractor extend the study activities an additional study year. This will require the contractor to conduct active surveillance, routine SARS-CoV-2 testing, period sera collection, and all other cohort activities through April 30, 2023. Allowing for data finalization and close out activities, the period of performance would need to conclude on September 30 2023 instead of 24 April 2022.

This study, unique to the Contractor, presents a novel solution and design to the BAA topic for which it was submitted. CDC selected the Contractor’s research proposal for award and as a result issued Contract 75D30120C08150. This study began in April 2020 and has successfully completed tasks described in Section 3, above.

Because Abt Associates has completed all study activities to date, manages subcontracts with existing study sites, and has established systems to conduct all required evaluations, Abt Associates is uniquely qualified to address CDC's expanded tasks and period of evaluation and is the only responsible source who can supply these services. First, because Abt Associates currently operates a large prospective cohort of over 4,000 participants they are able to extend these activities and address CDC’s needs in an efficient and effective manner. This collaboration and their use of common surveillance and laboratory methods ensures that CDC is able to compare and combine results across cohorts in a valid, reliable, and timely manner. A different contractor would not be able to implement a cohort study of this size using a common methodology which would jeopardize the scientific validity and reliability of the data CDC receives and has received to date. It is essential that the new required information be added to this network in a way that is comparable and collapsible with the existing study results to date. CDC has not found alternative capability to date, but should a hypothetical alternative capability existing, this new contractor would require at least 6 months from contract award to establishing a new cohort of this size, while in contrast the existing Contractor could ramp up seamlessly. Second, this effort to date has included conducting special investigations of key knowledge gaps and partnering with CDC to update CDC, White House Leadership, and the Advisory Committee of Immunization Policy (ACIP) in a timely manner and publish results in various medical journals. This partnership has been built on over 18 months of existing work and reporting thereby having established reliability and public trust in the output. A new Contractor would require a similar amount of time to gain this experience and public trust in the output of investigation results. Additionally, there would be a lapse in investigative coverage by switching Contractors at this point which would impede on data gathering, analysis, and collaboration amongst study partners and overall investigative output cadence and rigor. Third, given the unprecedented urgency and time pressure for study findings, delays in identifying and launching a new contractor would risk delaying CDC's ability to make evidence-based policy decision and in turn potentially jeopardize public health and safety.

The impact to American lives affected or lost due to unacceptable delays to rebuild a similar study are inestimable. The research from this contract is critically needed to help CDC understand how to align national public health policies to minimize the continued loss of life and compromised health for Americans.