REV 75D301-22-R-72191_MS Word_Tracked Changes_5.5.22.docx

SOLICITATION, OFFER AND AWARDPAGES

1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

2. CONTRACT NO.

3. SOLICITATION NO.

75D301-22-R-72191

4/20/22

6. REQUISITION/PURCHASE NO.

00HCVJEG-2022-63011

Approved as to Form and Legality: _____________________________

NOTE: In sealed bid solicitations “offer” and “offeror” mean “bid” and “bidder.”

SOLICITATION

(Hour)

CAUTION -- LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME

Liubov Kriel

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

7704882856

C. E-MAIL ADDRESS

vyh1@cdc.gov

11. TABLE OF CONTENTS

(x)PAGE(S)

SEC.

SEC.

PAGE(S)

DESCRIPTION

(x)

DESCRIPTION

XK

REPRESENTATIONS, CERTIFICATIONS, AND

OFFER (Must be fully completed by offeror)

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

12. In compliance with the above, the undersigned agrees, if this offer is accepted within calendar days (60 calendar days unless a differentCALENDAR DAYS

(Type or Print)

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

18. OFFER DATE

AWARD (To be completed by Government)

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION

Centers for Disease Control and Prevention (FMO) PO Box 15580 404-718-8100

Atlanta, GA 30333-0080

26. NAME OF CONTRACTING OFFICER (Type or print)

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

IMPORTANT -- Award will be made on this form, or on Standard Form 26, or by other authorized official written notice.

FAR (48 CFR) 53.214©

Section B - Supplies Or Services And Prices/Costs

· Time and Materials CLIN

· CLIN 0001 is a Non-severable Line Item

Performance Period: 09/01/2022 through 08/31/2026

1 Job

NOT TO EXCEED:

· Cost-Reimbursable CLIN

Performance Period: 09/01/2022 through 08/31/2026

$12,500.00

Section C - Description/Specification/Work Statement

Title: Cost and Cost Effectiveness of TBESC-III LTBI Primary Care Interventions

SECTION 1 – BACKGROUND

The Centers for Disease Control and Prevention’s (CDC) domestic tuberculosis (TB) programmatic research efforts focus on latent TB infection (LTBI) screening among persons at high risk for tuberculosis and successfully and completely treating persons with LTBI to reduce progression to TB disease. The Tuberculosis Epidemiologic Studies Consortium-III (TBESC-III) launched in September 2021 with the goal of advancing U.S. TB elimination efforts by focusing on addressing LTBI in high-risk, non-U.S.–born populations in primary care settings. The objective of TBESC-III is to use implementation science to identify primary care interventions that are both effective and efficient at increasing LTBI targeted testing and treatment. The aims of TBESC-III are to: 1) identify primary care systems/settings that serve non-U.S.–born persons at risk for LTBI and TB disease, 2) collect retrospective and prospective electronic medical record data, 3) design and implement clinical care-based interventions to improve performance measures across the LTBI care cascade, and 4) monitor and evaluate intervention performance over time to identify efficient and effective strategies.

As part of TBESC-III, each contracted organization (i.e., site) is required to develop and implement a plan to collect data necessary to evaluate the costs and cost effectiveness of their planned interventions compared to a baseline period (i.e., pre/postintervention). For the baseline period, effectiveness indicators and cost data will be submitted once during the intervention period, effectiveness indicators will be submitted quarterly and cost data at 6-month intervals. TBESC-III sites will submit the required data to CDC, which will then provide the data to the awardee of this contract. The awardee of this contract will perform quality assurance on the cost data and cost-effectiveness analyses of the interventions using the TBESC-III data.

SECTION 2 – PURPOSE

The purpose of this requirement is to estimate the value to the healthcare system and society of clinical care-based interventions that improve performance measures across the LTBI care cascade. The interventions are funded through contracts with four different TBESC-III sites, which focus on increasing identification of persons at high risk for LTBI, increasing testing with recommended diagnostics, and ensuring treatment of LTBI among non-U.S.–born persons in U.S. primary care settings.

SECTION 3 – SCOPE OF WORK

The contractor shall hold primary responsibility for ensuring the completion of the TBESC-III cost-effectiveness analysis. The contractor shall review the effectiveness and cost data submitted to CDC by TBESC-III sites, and design and carryout the cost-effectiveness analyses in collaboration with the TBESC-III sites, listed below:

· Denver Health and Hospital Authority,

· Kaiser Foundation Research Institute,

· Public Health – Seattle & King County, and

· The Regents of the University of California, San Francisco.

This requirement will also involve collaboration with CDC’s Division of TB Elimination (DTE); Surveillance, Epidemiology, and Outbreak Investigations Branch (SEOIB) staff. DTE/SEOIB leads the TBESC. Collaboration with other CDC staff (e.g., economists, evaluators) may also be required.

Objectives

The overall objective is to provide CDC with an estimation of the potential health and economic impacts of TBESC-III clinical care-based interventions.

The specific project objectives are to:

· Use new or adapt existing evidence-based economic models that employ comparable and consistent cost-effectiveness methodology to assess the health and economic impacts of implementing TBESC-III clinical care-based interventions.

· Populate these models with the characteristics of primary care populations or clinics targeted for TBESC-III clinical care-based interventions.

· Use sensitivity analyses along with simulation exercises to assess and generate estimated impacts of the TBESC-III clinical care-based interventions according to agreed-upon timeframes.

SECTION 4 – TASKS TO BE PERFORMED

The contractor shall, independently and not as the agent(s) of the Government, furnish all of the necessary services, qualified personnel, material, equipment, and facilities to design and carry out analyses to determine the cost and cost effectiveness of TBESC-III clinical care-based interventions.

All analyses shall conform to the guidance below or other relevant reference documents (see Section 8 – Reference Materials). Where guidance for analyses is in conflict, the contractor shall provide to CDC a recommendation for which guidance to follow, and CDC shall make the final decision.

Additionally, the contractor shall collaborate with CDC’s Division of TB Elimination (DTE); Surveillance, Epidemiology, and Outbreak Investigations Branch (SEOIB) and other CDC staff (e.g., economists, evaluators) throughout the period of performance.

Task 1: Develop cost-effectiveness analysis plan The contractor shall:

1.1 Frame the cost-effectiveness analysis to include:

a. Time frame of the intervention.

b. Perspectives to be analyzed, including at least a healthcare system perspective and a societal perspective. If the outcomes at the TBESC-III site are expected to differ by clinic within the site, the perspective of the primary care clinic might be also used.

c. Analytic horizon, i.e., the period of costs and effectiveness that will be analyzed.

d. 3% annual discounting for all future costs and outcomes, related to the intervention.

1.2 Identify data needed for cost-effectiveness analysis.

1.3 Define key assumptions.

1.4 Create or adapt a cost-effectiveness model.

Task 2: Conduct monthly project management calls with CDC, and consult with TBESC-III sites (as needed) The contractor shall:

2.1 Conduct a one-hour telephone call monthly with the Contracting Officer’s Representative (COR) and relevant CDC project staff to discuss and report on project management issues and provide minutes or a summary after the call that documents the discussion, decisions made, and next steps.

2.2 Provide virtual technical assistance to TBESC-III research sites regarding data collection and elements related to the cost and cost-effectiveness analysis (e.g., feedback or advice about data collection changes needed, potential substitute data variables/elements, cost data collection methods, etc.) as directed by the COR. Any technical assistance that is provided by the contractor shall be reported verbally to the COR during the applicable monthly project management calls and documented in the call minutes or summary that the contractor will deliver to the COR after the call (see Task 2.1).

Task 3: Review cost data Upon receipt of baseline, start-up, and each batch of intervention cost data from CDC, the contractor shall review data for clarity, accuracy, and comprehensiveness.

Task 4: Finalize/approve cost data The contractor shall communicate to the COR, CDC staff, and TBESC-III sites any issues found during their quality control/assurance process and collaborate with all parties to ensure data revisions. This shall occur through summary reports provided by the contractor to the COR, as well as one-hour telephone calls with the COR and relevant CDC project staff to review and discuss any need for clarification of the cost data or any other topic related to the cost data provided by CDC. The contractor shall provide minutes or a summary after each call that documents the discussion, decisions made, and next steps.

Task 5: Categorize baseline cost data The contractor shall categorize baseline cost data for each of the four TBESC-III sites. Baseline costs are costs of targeted testing and treatment (TTT)-related activities during the baseline period prior to the intervention. These costs will be compared with intervention costs to assess the additional cost of the intervention. Baseline costs shall include:

a. Costs to the healthcare system:

i. Time and value of time of staff involved in baseline TTT activities

ii. Costs of medical exams, medications/treatment regimens, supplies, travel, and other related costs for baseline TTT activities (including administration).

b. Costs to patients for:

i. Out-of-pocket expenses

ii. Non-insurance covered billed services (from claims data)

iii. Travel (patient reported)

iv. Travel costs (estimated by observation and via interviews)

v. Day or adult care

vi. Other costs related to LTBI testing or treatment

vii. Lost pay and work time (lost productivity)

Task 6: Categorize start-up intervention costs The contractor shall categorize the start-up intervention costs using data provided to CDC by each of the four TBESC-III sites. Start-up costs are costs to begin the project and are incurred before the project is implemented. These include costs to develop project components and any capital investments that are used for the length of the project. Start-up costs shall include:

a. Labor time/value and supplies to plan and coordinate the intervention start-up, including communication, outreach, and meetings.

b. Changing or updating the electronic medical record (EMR) for the intervention, including costs of:

i. Clinic staff time to create the proposal for modifying the EMR

ii. Initial and fixed costs to implement changes to the EMR system, including costs of software or hardware upgrades and contracts for security and maintenance

c. Capital investments as fixed costs, such as new diagnostic equipment. If equipment can be used for periods extending past the project period or for purposes other than for the project, their costs relevant to the project period and activities should be calculated.

d. Start-up costs shall not include sunk costs. Costs such as educational materials or screening questionnaires developed for the project are considered sunk costs and are not expected to recur if the project were to be expanded or implemented in a different location (e.g., after developed, such educational materials can be shared).

Task 7: Categorize intervention implementation costs

7.1 The contractor shall categorize intervention implementation costs every six months from intervention start. Intervention implementation costs shall include:

a. Time and the value of time for staff to:

i. Identify populations for project recruitment

ii. Conduct outreach to populations and communities

iii. Conduct patient diagnostic exams

iv. Start patients on treatment

v. Follow-up with patients to ensure treatment completion

vi. Identify and treat adverse events due to treatment

vii. Conduct intervention data management and linking data

b. Costs to primary care providers for medical exams, including IGRAs, chest radiographs, computed tomography, NAAT, and other diagnostic exams. If costs are through contracts, report contract rates.

c. LTBI medications and treatment regimens

d. Patient incentives, by incentive type

e. Intervention-related travel costs, such as mileage costs or mass transit fares to conduct outreach or patient follow-up

f. Reimbursements for:

i. TB/LTBI related clinic services

ii. Clinic visits

iii. Tests/diagnostics

iv. Treatment

v. Other items (such as for interpretation services)

g. Out-of-pocket costs for patients for

i. Billed services not covered by insurance (e.g., from claims data)

ii. Travel (patient reported)

iii. Travel costs (estimated by observation and via interviews)

iv. Day care for children or for adult care

v. Other costs related to LTBI testing or treatment (i.e., food, parking)

h. Costs to patients in the form of lost pay and work time (lost productivity) due to clinic visits or side effects

7.2 The contractor shall ensure that:

a. Variable and fixed costs are distinguished.

b. Costs are further categorized according to LTBI care cascade steps:

i. Identification of populations for testing,

ii. Diagnosis of LTBI overall and by type of test, including exclusion of TB disease,

iii. Initiation of LTBI treatment overall and by regimen,

iv. Halting of treatment due to adverse events, including emergency room utilization and hospitalization, and

v. Completion of LTBI treatment overall and by regimen.

Task 8: Identify TB disease costs The contractor shall specify sources, values, and assumptions to be used for:

a. The costs of TB diagnosis and treatment.

b. The estimated value of TB-related deaths.

Task 9: Adjust costs The contractor shall:

9.1 Adjust costs for inflation to put all costs in common year dollars

9.2 For cost comparisons across TBESC-III sites, adjust costs for price parity. Cost comparisons shall include:

a. Personnel costs

b. Exam costs (e.g., IGRA, chest imaging, NAAT, smear/culture)

c. Medication and treatment regimen costs

d. Costs to change the EMRs

e. Other relevant cost comparisons to be determined during the project

Task 10: Report costs to CDC

10.1 The contractor shall summarize baseline, intervention start-up, and intervention implementation costs of TBESC-III activities. Submit draft and final reports to CDC of:

a. Annual baseline costs

b. Start-up intervention costs

c. Preliminary intervention costs, from submissions every 6 months

d. Annual intervention costs

e. Total (over the entire intervention period) intervention costs

10.2 Include the following data elements in each report:

a. Healthcare system perspective:

i. Variable costs

ii. Fixed costs

b. Societal perspective

i. Healthcare system costs

ii. Costs to patients

c. Possible additional perspectives (primary care clinic, by population served, etc.)

d. Discussion of current progress, problems and proposed corrective actions, and the work forecast for the next period

Task 11: Specify efficiency and effectiveness measures The contractor shall:

11.1 Obtain from CDC the baseline effectiveness indicators (i.e., care cascade elements) by primary care population and by LTBI regimen (and by clinic, if using a clinic perspective) at each TBESC-III site.

11.2 Obtain from CDC and analyze the preliminary (quarterly) and final effectiveness indicators (i.e., care cascade elements) for each intervention primary care population and by LTBI regimen (and by clinic, if using a clinic perspective) at each TBESC-III site.

11.3 Specify sources, values, and assumptions to be used for:

a. Efficacy of LTBI treatment completion in preventing TB

b. Efficacy of partial (incomplete) LTBI treatment in preventing TB

c. Incidence of TB disease (remaining lifetime). True LTBI will be estimated using test positivity and estimated lifetime reactivation. Estimates of TB reactivation from LTBI by population shall be obtained from Shea et al. (AJE 2014), from Woodruff (JIMH 2020), from updated analyses by modelers in the NCHHSTP Epidemiologic and Economic Modeling Agreement (NEEMA), or from another source agreed upon by CDC and TBESC III stakeholders.

d. Incidence of TB-related deaths

e. Remaining life years and QALYs with TB and LTBI, and other relevant conditions

Task 12: Calculate net costs The contractor shall calculate net costs by subtracting the costs of prevented TB from programmatic costs.

Task 13: Calculate and report efficiency indicators.

The contractor shall report to CDC the cost per LTBI case detected and completely treated and the number of each population needed to be screened to diagnose a case of LTBI (NNS) and the number needed to be treated to prevent a TB case (NNT).

Task 14: Conduct cost-effectiveness analyses The contractor shall:

14.1 Estimate ICERs of the intervention compared with baseline per TB case prevented, per TB death prevented, and per QALY gained from at least the healthcare system and societal perspectives.

14.2 Conduct preliminary cost-effectiveness analyses showing ICERs by population and by LTBI regimen of each site’s intervention compared with baseline.

14.3 Calculate the ICER of the intervention compared with the baseline using selected perspectives.

14.4 Through sensitivity analyses, identify key variables and their values that significantly affect the results.

14.5 Assess the impact of uncertainty of parameter inputs on results.

14.6 Summarize results in tables and journal article format.

14.7 Consult on analysis plans, data inputs, and preliminary and final results with CDC staff and TBESC-III sites during monthly calls and semi-annually following receipt of data throughout the project.

14.8 Come to agreement with CDC staff and TBESC-III sites on final cost-effectiveness analyses results.

Task 15. Report results The contractor shall:

15.1 After submission of draft reports to TBESC-III sites and CDC staff, respond to requested edits and changes to finalize cost and cost-effectiveness reports.

15.2 With CDC and TBESC-III co-authors, the contractor shall first-author a journal article about the study results for peer-reviewed journal submission.

15.3 Finalize the journal article upon journal acceptance.

15.4 Provide CDC with the model and database used for the final analyses.

SECTION 5 – GOVERNMENT FURNISHED MATERIALS

No government-furnished materials will be included as part of this contract.

SECTION 6 – DELIVERABLES/REPORTING SCHEDULE

COR

COR

COR

COR

COR

COR

SECTION 7 – REFERENCE MATERIALS

Publications:

Haddix AC (Editor), Teutsch SM (Editor), Corso PS (Editor). Prevention Effectiveness: A Guide to Decision Analysis and Economic Evaluation 2nd Edition. Oxford University Press; 2nd edition. 2002.

Muennig P, Bounthavong M. Cost-Effectiveness Analysis in Health: A Practical Approach. Jossey-Bass; 3rd Edition. 2016.

Neumann PJ (Editor), Ganiats TG (Editor), Russell LB (Editor), Sanders GD (Editor), and Siegel JE (Editor). Cost-Effectiveness in Health and Medicine. Oxford Press. 2016.

Neumann PJ, Sanders GD. Cost-Effectiveness Analysis 2.0. N Engl J Med. 2017 Jan 19;376(3):203-205.

Sanders GD, Neumann PJ, Basu A, Brock DW, Feeny D, Krahn M, Kuntz KM, Meltzer DO, Owens DK, Prosser LA, Salomon JA, Sculpher MJ, Trikalinos TA, Russell LB, Siegel JE, Ganiats TG. Recommendations for Conduct, Methodological Practices, and Reporting of Cost-effectiveness Analyses: Second Panel on Cost-Effectiveness in Health and Medicine. JAMA. 2016 Sep 13;316(10):1093-103.

Definitions:

Analytic horizon: Period over which costs and outcomes occur due to the intervention/program.

Cost analysis: Systematic collection and analysis of the costs of an intervention/program.

Discounting: The process of converting future dollars and future health outcomes to their present values; applying an annual social discount rate of 3% is standard (with sensitivity analyses ranging from 1% to 5%).

Economic costs: The value of resources used to produce a good or service or the value of forgone opportunities (i.e., opportunity cost of resources used); charges (often how hospitalization is described) are often much more than economic costs; reimbursements could be more or less than the economic costs.

Effects: Health outcomes, such as TB cases and deaths prevented, years of life gained, or QALYs.

Effectiveness: How well the intervention prevents adverse health outcomes or preserves life years or QALYs; as defined by the TBESC-III contract, maximizing the number of LTBI cases detected and completely treated according to CDC guidelines; combined with assumptions about the efficacy of LTBI treatment completion, effectiveness can also be described in terms of TB cases prevented, TB deaths prevented, years of life gained, and QALYs gained.

Efficacy: The impact of a treatment or intervention in preventing adverse health outcomes or preserving life years or QALYs under ideal conditions.

Efficiency: In general, efficiency is the highest level of output that uses the least amount of inputs.

Healthcare system costs: These include the costs of healthcare personnel; laboratory/medical diagnostic and treatment exams; medications; clinic visits; hospitalization; treatment of side effects including chronic disease; supplies; costs of providing healthcare education; counseling, and training; and costs paid by third-party payers (e.g., insurance companies). Program costs include both fixed costs that do not vary by the number of patients and variable costs that do.

TB and LTBI diagnosis costs: These include the value of provider time spent assessing symptoms and medical history, interferon-gamma release assays (IGRA), chest imaging, nucleic-acid amplification tests (NAAT), sputum or specimen smear exams for acid-fast bacilli (AFB) and culture for Mycobacterium tuberculosis.

Out-of-pocket costs: These are paid by patients and are included in healthcare system costs; may include costs to patients, such as child or adult care, transportation, lodging, etc., while away for treatment.

Incremental cost-effectiveness analysis: An analytic tool which combines the costs and effects of at least two scenarios; after ordering the scenarios from least to most effective, the incremental cost-effectiveness ratio (ICER) is calculated as the subtraction of the net costs of the less effective scenario from that of the more effective scenario, divided by the subtraction of the effectiveness of the less effective scenario from that of the more effective scenario; in other words, the ratio of incremental cost to incremental effect; net costs are the programmatic costs associated with the scenario minus the costs of outcomes prevented.

Inflation adjustment: Standardization of costs to be in the same base year.

Intervention time frame: The period of the intervention or program.

Life years gained: The number of years of life gained because of the intervention/program.

Perspective: Who incurs (pays) the costs? Typically, at least two perspectives are analyzed and presented: healthcare system perspective and societal perspective. Other perspectives might include those of the healthcare clinic or the patient.

Healthcare system perspective: A perspective for conducting a cost-effectiveness analysis that includes formal health care sector (medical) costs borne by third-party payers and paid out-of-pocket by patients; these third-party and out-of-pocket medical costs include current and future costs.

Societal perspective: A perspective for conducting a cost-effectiveness analysis that incorporates all costs and health effects regardless of who incurs the costs and who obtains the effects; notably, the cost of productivity losses and those of premature mortality are included in this perspective, as well as costs from the healthcare system perspective.

Price parity adjustment (i.e., cost of living): Standardizing costs across geographic areas, which differ because prices differ by geographic area. The U.S. Bureau of Economic Analysis publishes the Regional Price Deflator series (https://www.bea.gov/data/prices-inflation/regional-price-parities-state-and-metro-area).

Quality-adjusted life-year (QALY): A measure of health outcome that assigns a weight to each period (ranging from 0 to 1), corresponding to the health-related quality of life during that period, in which a weight of 1 corresponds to optimal health and a weight of 0 corresponds to a health state judged equivalent to death; these are then aggregated across periods.

Sensitivity analyses: Varying inputs to identify variables and or their parameters having the greatest impact on the results.

Societal costs: All costs and health effects regardless of who incurs the costs and who obtains the effects; estimates should include healthcare system costs and as many other types of costs as possible, but at least productivity losses.

Productivity losses (i.e., indirect costs or time costs) due to morbidity: These include patient and caregiver lost paid work, lost uncompensated work time, and lost home production or leisure time due to morbidity.

Productivity losses (i.e., indirect costs or time costs) due to premature mortality: These are often measured using the human capital method, by the estimated present value of future earnings/production at the age at death.

Section D - Packaging And Marking

There are no clauses/provisions included in this section.

Section E - Inspection And Acceptance

E.1 FAR 52.252-2 Clauses Incorporated by Reference (Feb 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/

(End of Clause)

Section F - Deliveries Or Performance

Section G - Contract Administration Data

G.1 Contract Representatives

Contract Specialist (CS) & Contracting Officer (CO) responsible for this contract:

Liubov Kriel Centers for Disease Control and Prevention (CDC) Office of Financial Resources (OFR) Office of Acquisition Services (OAS) 2900 Woodcock Blvd, Atlanta, GA 30341-4146 Phone: (770) 488-2856 Email: vyh1@cdc.gov

Contracting Officer’s Representative (COR) responsible for this contract:

TBD

Centers for Disease Control and Prevention (CDC) National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) Telephone Number: TBD E-mail Address: TBD

(End of Clause)

G.2 CDCP_G009 Contracting Officer (CO) (Jul 1999)

(a) The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds. No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions, or other stipulations of this contract.

(b) No information, other than that which may be contained in an authorized modification to this contract, duly issued by the Contracting Officer, which may be received from any person employed by the United States Government, or otherwise, shall be considered grounds for deviation from any stipulation of this contract.

G.3 CDC0_G008 Contracting Officer’s Representative (COR) (Jul 2017)

Performance of the work hereunder shall be subject to the technical directions of the designated COR for this contract.

As used herein, technical directions are directions to the Contractor which fill in details, suggests possible lines of inquiry, or otherwise completes the general scope of work set forth herein. These technical directions must be within the general scope of work and may not alter the scope of work or cause changes of such a nature as to justify an adjustment in the stated contract price/cost, or any stated limitation thereof.

In the event that the Contractor believes full implementation of any of these directions may exceed the scope of the contract, he or she shall notify the originator of the technical direction and the Contracting Officer, immediately or as soon as possible, in a letter or e-mail separate of any required report(s). No technical direction, nor its fulfillment, shall alter or abrogate the rights and obligations fixed in this contract.

The Government COR is not authorized to change any of the terms and conditions of this contract. Contract changes shall be made only by the Contracting Officer by properly written modification(s) to the contract.

The Government will provide the Contractor with a copy of the COR delegation memorandum upon request.

G.4 CDCP_G010 Contract Communications/Correspondence (Jul 1999)

The Contractor shall identify all correspondence, reports, and other data pertinent to this contract by imprinting thereon the contract number from Page 1 of the contract.

G.5 CDC0_G018 Payment by Electronic Funds Transfer (Feb 2018)

(a) The Government shall use electronic funds transfer to the maximum extent possible when making payments under this contract. FAR 52.232-33, Payment by Electronic Funds Transfer –System for Award Management, in Section I, requires the contractor to designate in writing a financial institution for receipt of electronic funds transfer payments.

(b) In the case that EFT information is not within the System of Award Management, FAR 52.232-34 requires mandatory submission of Contractor’s EFT information directly to the office designated in this contract to receive that information (hereafter: “designated office”); see below. The contractor shall submit the EFT information within the form titled “ACH Vendor/Miscellaneous Payment Enrollment Form” to the address indicated below. Note: The form is either attached to this contract (see Section J, List of Attachments) or may be obtained by contacting the Contracting Officer or the CDC Office of Financial Resources at 678-475-4510.

(c) In cases where the contractor has previously provided such information, i.e., pursuant to a prior contract/order, and been enrolled in the program, the form is not required unless the designated financial institution has changed.

(d) The completed form shall be mailed after award, but no later than 14 calendar days before an invoice is submitted, to the following address:

The Centers for Disease Control and Prevention Office of Financial Resources (OFR) P.O. Box 15580 Atlanta, GA 30333 Or – Fax copy to: 404-638-5342

G.6 HHSAR 352.232-71: Electronic Submission of Payment Requests (DATE TBD)

(a) Definitions. As used in this clause—

(1) “ Payment request” means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request.

(End of clause)

Unless further changes are required, the Department of Health and Human Services shall notify the Contractor of the effective date of the clause at HHSAR 352.232-71 Electronic Submission of Payment Requests by providing written notice to the Contractor within thirty (30) days of implementing the HHS Electronic Invoicing Implementation Project (E-Invoicing) and within thirty (30) days of the anticipated finalization of the clause at HHSAR 352.232-71 Electronic Submission of Payment Requests, via public special notice issued through the SAM.gov portal. However, for purposes of this award or modification, the effective date shall be the date signed by the parties.

G.7 CDC42.0002 Evaluation of Contractor Performance Utilizing CPARS (Aug 2021)

In accordance with FAR 42.15, the Centers for Disease Control and Prevention (CDC) will review and evaluate contract performance. FAR 42.1502 and 42.1503 requires agencies to prepare evaluations of contractor performance and submit them to the Contractor Performance Assessment Reporting System (CPARS). The CDC utilizes this web-based system to prepare and report contractor performance evaluations. All information contained in these assessments may be used by the Government, within the limitations of FAR 42.15, for future source selections in accordance with FAR 15.304 where past performance is an evaluation factor.

The CPARS system requires a contractor representative to be assigned so that the contractor has appropriate input into the performance evaluation process. The CPARS contractor representative will be given access to CPARS and will be given the opportunity to concur or not-concur with performance evaluations before the evaluations are complete. The CPARS contractor representative will also have the opportunity to add comments to performance evaluations.

The assessment is not subject to the Disputes clause of the contract, nor is it subject to appeal beyond the review and comment procedures described in the guides on the CPARS website. Refer to: www.cpars.gov for details and additional information related to CPARS, CPARS user access, how contract performance assessments are conducted, and how Contractors participate. Access and training for all persons responsible for the preparation and review of performance assessments is also available at the CPARS website.

The contractor must provide the CDC contracting office with the name, e-mail address, and phone number of their designated CPARS representative who will be responsible for logging into CPARS and reviewing and commenting on performance evaluations. The contractor must maintain a current representative to serve as the contractor representative in CPARS. It is the contractor’s responsibility to notify the CDC contracting office, in writing (letter or email), when their CPARS representative information needs to be changed or updated. Failure to maintain current CPARS contractor representative information will result in the loss of an opportunity to review and comment on performance evaluations.

G.8 CDC42.0003 Billing Rates (May 2015)

(a) As defined in FAR Subpart 42.7, Billing Rate means an indirect cost rate established temporarily for interim reimbursement of incurred indirect costs. Billing rates may be adjusted as necessary pending establishment of final indirect rates

(b) Notwithstanding the provisions of the clause entitled Allowable Cost and Payment (FAR 52.216-7), allowable indirect costs under this contract shall be determined by applying the following provisional billing rates to the bases specified below:

Bases: (1)

(c) The above rates are provisional billing rates only and shall apply from the date of award until such time as the rates are revised by modification. Any modification to change the above rates will also state the effective period covered by the revised rates.

(d) Billing rates may be prospectively or retroactively revised by mutual agreement of the Contracting Officer and the contractor at either party’s request. When agreement cannot be reached, the billing rates may be unilaterally determined by the Contracting Officer as set forth in FAR 42.704.

(e) Final indirect rates shall be established in accordance with FAR Clause 52.216-7, Allowable Cost and Payment. As required by that clause, the contractor shall submit an adequate final indirect cost rate proposal to the Contracting Officer and auditor within the 6 month period following the expiration of each of its fiscal years. Upon receipt of the final indirect cost rate proposal and pending the establishment of final indirect cost rates, the contractor and the Government may mutually agree to revise the provisional billing rates to reflect the proposed indirect cost rates until the proposal has been audited and settled.

Section H - Special Contract Requirements

H.1 CDCA_H042 Records Management Obligations (Jun 2020) A. Applicability The following applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

1. includes Centers for Disease Control and Prevention (CDC) records.

1. does not include personal materials.

1. applies to records created, received, or maintained by Contractors pursuant to their CDC contract.

1. may include deliverables and documentation associated with deliverables.

C. Requirements

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

1. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

1. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

1. CDC and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of CDC or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to the Contracting Officer and the Contracting Officer’s Representative. The agency must report promptly to NARA in accordance with 36 CFR 1230.

1. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the contract. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to CDC control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the contract. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

1. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and CDC guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

1. The Contractor shall only use Government IT…