JOFOC.pdf

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

Acquisition Title: RSV Modeling, Cost Assessments, and Health Utility Analyses

Agency: CDC

Acquisition Year (FY): 2022

Author and Title: Lee Ann Ramsey, COR II

2. Description of Action:

Nature: New Requirement Follow-on Requirement

Modification to Existing Purchase Order/Contract Number:

Pricing: Firm-Fixed Price Time & Materials Cost

Other:

Funds: OMA Other Funds:

Name of Proposed Contractor(s): Regents of the University of Michigan

Street Address: 3003 South State Street

City, State, Zip: Ann Arbor, Michigan 48109

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 $ 250,000

The purposes of this procurement is to acquire research services to (1) estimate out-of-pocket and time costs associated with respiratory syncytial virus (RSV) illness by designing and implementing appropriate survey methods, including sample recruitment; (2) estimate health utilities for the spillover quality of life effects of an adult’s RSV illness on their caregiver by implementing appropriate survey methods, including sample recruitment; and (3) develop mathematical models to estimate the population burden of disease in the US population level to estimate the annual resource utilization

(outpatient visits, hospitalizations), total cases, total costs, deaths, and quality-adjusted life years lost due to RSV and will provide essential information on the potential cost-effectiveness of a hypothetical RSV vaccine or prophylactic antibody treatments. The contractor will deliver a written report and present findings to the Advisory Committee on Immunization

Practices (ACIP) to inform decision making on the cost-effectiveness of newly developed RSV vaccines in February 2023.

4. Authority and Rationale: FAR Subpart 13.5, 41 U.S.C. 1901

The University of Michigan is the only source that can produce the required deliverable items by the agency's December

2022 deadline.

The University of Michigan has previous peer-reviewed experience modeling transmission and cost-effectiveness of respiratory diseases, specifically related to RSV. No other vendor is known to possess the the expertise, data, and coding to accomplish this work now.

The University of Michigan has previous experience fielding health utility assessment surveys for respiratory diseases and

RSV-specific health utilities surveys for adults, children, and caregivers of children. This data is owned by the University of Michigan and will be a necessary input into the cost-effectiveness models under this requirement. The survey instruments used in these previous surveys have been pre-tested and are in place to be rapidly modified to meet the requirements of this work.

The University of Michigan is the only vendor known to have expertise with multiple types of burden being assessed in one survey (i.e., Productivity Loss, Caregiver Time, & Out-of-Pocket Costs) coupled with the modeling experience and health utilities surveys in place.

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

Additional sources will be considered for any future work, contingent on the availability of other sources to meet urgent requirements.

6. Bridge Contracts:

N/A

7. Actions to Increase Competition:

A notice was publicized as required by FAR Subpart 5.2 on July 7, 2022. The response period ended July 14, 2022. No responses were received.

8. Market Research:

Web searches and a consideration of other researchers who have provided similar cost-effectiveness analysis to the ACIP.

These other researchers lack specific elements of the expertise required for this work.

9. Procurement History:

N/A

10. Additional Information to support the justification:

This is an urgent requirement to inform ACIP decision-making.

11. Technical / Requirements Certification: By my signature below, I certify that the supporting data included in this

J&A is accurate and complete.

Name: Lee Ann Ramsey, COR II Signature: _______________________

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.

CDC has data on prices paid for previous similar survey work and modeling, which will be leveraged to determine fair and reasonable pricing. Price analysis will be used. Cost analysis may be used if necessary to determine that the price is fair and reasonable.

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: Joshua Houston, Contracting Officer Signature: _______________________