RFQ 75D30122Q74843.pdf

REQUEST FOR QUOTATIONS

(THIS IS NOT AN ORDER)

THIS RFQ IS X IS NOT A SMALL BUSINESS SET-ASIDE.

PAGE OF PAGES

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1. REQUEST NO.

75D301-22-Q-74843

2. DATE ISSUED

06/29/2022

3. REQUISITION/PURCHASE REQUEST NO.

00HCVLEG-2022-62731

4. CERT. FOR NAT. DEF.

UNDER BDSA REG. 2

AND/OR DMS REG. 1

RATING

5a. ISSUED BY Centers for Disease Control and Prevention (CDC) Office of Acquisition Services (OAS) 2900 Woodcock Blvd, MS TCU-4 Atlanta GA 303414004

6. DELIVERY BY (Date)

5b. FOR INFORMATION CALL (No collect calls)

NAME TELEPHONE NUMBER

AREA CODE NUMBER

Saulat Rehan (CTR) 678 475-4500

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10. PLEASE FURNISH QUOTATIONS TO

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07/12/2022 2:00PM EST

IMPORTANT: This is a request for information, and quotations furnished are not offers. If you are unable to quote, please so indicate on this form and return it. This request does not commit the Government to pay any costs incurred in the preparation of the submission of this quotation or to contract for supplies or services.

Supplies are of domestic origin unless otherwise indicated by quoter. Any representations and/or certifications attached to this Request for Quotations must be completed by the quoter.

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CDC Contract Spec. (Contractor): Saulat Rehan E-mail: qaz7@cdc.gov

All questions and quotes must include RFQ number 75D301-22-Q-74843

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AUTHORIZED FOR LOCAL REPRODUCTION STANDARD FORM 18 (REV. 6-95)

Previous edition not usable Prescribed by GSA FAR (48 CFR) 53.215-1(a)

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RFQ 75D301-22-Q-74843

Line Items

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

0001 Anthrax in Kyrgrzstan Study

Firm Fixed Price Non Severable Services

Period of Performance: August 1, 2022- July 31, 2024

1 Job

SECTION C. STATEMENT OF WORK

PILOT STUDY TO IDENTIFY RISK FACTORS FOR SUSCEPTIBILITY TO ANTHRAX AND EVALUATE ANTITOXIN

EFFECTIVENESS FOR SYSTEMIC ANTHRAX

C. 1 - BACKGROUND

Two of the major anthrax biopreparedness challenges faced by the United States Government (USG) are that there is little to no 1) data regarding clinical outcomes of the monoclonal antitoxin raxibacumab for patients with systemic anthrax and 2) knowledge of groups that might be at higher risk than healthy individuals for death or infection from B. anthracis.

The Bacterial Special Pathogens Branch (BSPB) in the National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) proposes to work in an anthrax endemic area to

1) collect data on clinical outcomes of an antitoxin in the group for whom it would be indicated in the US, i.e., patients with systemic anthrax and

2) perform a pilot study to assess the prevalence of common chronic diseases and social exposures so that we can later design a case-control study to identify risk factors for anthrax morbidity and mortality.

Characteristics that might affect susceptibility include demographic factors such as age and sex; the presence of chronic health conditions (i.e., oxidatively stressing conditions such as diabetes, obesity, hypertension, chronic obstructive pulmonary disease, iron overload, hepatitis B and C); and social history such as occupation, diet, and tobacco and alcohol exposures. BSPB is charged with developing recommendations for medical countermeasure allocation and patient triage; identifying risk factors associated with severe disease will assist BSPB in developing recommendations to ensure patients at greatest risk of severe disease are triaged for the appropriate level of care. Finally, the Government proposes to

3) collect and characterize isolates that display resistance.

Problem 1. The USG has Raxibacumab, a monoclonal antitoxin approved for systemic anthrax, in the Strategic National Stockpile. The USG has animal efficacy data and human safety data for all three antitoxins from prelicensure studies, but almost no human effectiveness (i.e., real-world use) data. Given the near absence of systemically ill anthrax cases in the United States (US), this antitoxin was approved based on the animal rule, and there have been only two instances where raxibacumab was used in ill persons that can be used to evaluate effectiveness– once in an unpublished case of anthrax meningitis in Spain, and recently in a systemically ill patient with a Bacillus tropicus infection which expressed both anthrax toxins. Data on real life antitoxin use and patient outcomes will help the USG evaluate the benefit of Raxibacumab in the National Stockpile.

Problem 2. Any attack on a populace with B. anthracis will be almost over in less time than it took to determine the high-risk populations for the last two pandemics – influenza H1N1 and SARS-CoV-2. There will not be enough time to determine whether any groups are at increased risk, or who might benefit most from targeted interventions with limited countermeasures. Evidence suggests that susceptibility to B. anthracis varies by animal species. For example, no natural cases occur in carnivores, omnivores have intermediate susceptibility, and herbivores are highly susceptible. However there is evidence that it varies among humans. In humans, of the 22 patients with confirmed anthrax in the 2001 US [postal service] anthrax attack, only one male and one female were under the age of 50.

Although denominator data from that same year are not available, the average age of postal service workers in 2004 was 47 [Census Bureau American Community Survey 1-Year Estimates, Public Use Microdata]). Welders comprised one fifth (7/35) of the anthrax cases for whom occupational data were available in the 1979 Sverdlovsk incident (accidental release of Bacillus anthracis from a bioeweapons facility). These data suggest that persons over 50 years of age and welders might be at increased risk of infection.

Problem 3. Although it is known 1) that Bacillus anthracis can be made resistant to a variety of antimicrobials by serial passage in media infused with increasing antimicrobial concentrations, and 2) that penicillin resistance occurs naturally, little is known of the lethality of resistant strains in humans or what drives penicillin or other resistance outside of a laboratory setting. A chief concern of biopreparedness specialists nationwide is the potential for an anthrax attack with a resistant strain.

Kyrgyzstan is a landlocked agricultural country with an average elevation of 2,700 meters, a population of 6.5 million, per capita income of ~$5,500, and a life expectancy of ~73 years. There are 4.4 hospital beds and 2.2 physicians per 1,000 population (compared to the US with 2.8 hospital beds and 2.6 physicians per 1,000 population) and 6.5% of the GDP is spent on healthcare (World Factbook: Kyrgyzstan). The city of Osh (population 250,000, 2017) is on the Western border and sits in one of four noncontiguous areas shown by ecological niche modeling to be high risk for animal anthrax.(3) Osh has a population of 1.37 million. Osh Regional Hospital is a 750-bed hospital that served more than 1.5 million patients in 2017. The Osh Region of Kyrgyzstan is endemic for anthrax, and cutaneous cases are usually hospitalized.

Unlike many countries where anthrax is endemic, it is standard practice in Kyrgyzstan to hospitalize all patients with a diagnosis of anthrax. From 2005 – 2015, 236 patients were hospitalized for anthrax (21.5 cases/year), with just under a third (31%) being classified as moderate to severe in nature. Sixty-eight percent (160/234) of the cases in this Kyrgyzstani case series were considered to be “mild” and were treated with seven days of either oral doxycycline or ciprofloxacin. Moderate cases (55/234, 24%) were treated with 10 days of oral doxycycline or ciprofloxacin plus IM penicillin, and severe cases (19/234, 8%) – those with high fever, toxemia, bacteremia, or organ involvement – received two weeks of intravenous ciprofloxacin and penicillin. Durations of hospitalization were approximately 2 weeks, 4 weeks, and 5 weeks for mild, moderate, and severe cases respectively. For the most recent five-year time period, 2016 – 2020 , there were 58 cases – for a slightly lower incidence of 11.6 cases/year.

Based on these data, an average of about three cases per year might be expected to be systemic anthrax and, based on our criteria, be candidates for antitoxin; however it could range from zero to ten. Antibiotic resistance was common: 63 patients had isolates resistant to ampicillin; 22 had isolates resistant to penicillin; 8, to ciprofloxacin;

and 4, to doxycycline.

C. 2 - PURPOSE

The purpose of this requirement is to work in an anthrax endemic area with high standards of in-hospital medical care to 1) collect data on clinical outcomes of an antitoxin in the group for whom it would be indicated in the US, i.e., patients with systemic anthrax; 2) assess the prevalence of oxidatively stressing common chronic diseases and exposures so that the Government can later design a case-control study to identify demographic, dietary, or social (e.g., smoking, drinking) variables or comorbidities that might serve as risk factors for anthrax morbidity and mortality; and 3) collect, store, and characterize isolates determined to exhibit antimicrobial resistance by correlating whole genome sequence changes to resistance levels (Broth Microdilution). Understanding 1) how well antitoxins work in a hospital setting, 2) whether any conditions or habits increase risk for B. anthracis infection, and 3) whether there are natural factors that contribute to the development of resistance will enhance USG biopreparedness for a wide-area release of B. anthracis.

The Kyrgyz Republic, which is endemic for anthrax, regularly identifies human anthrax cases. Treatment protocols are standardized and a consistent level of care is provided to patients with anthrax diagnoses. Moderate to severe cases are diagnosed annually, which is the target group for receiving antitoxin; because all anthrax cases are hospitalized, administration of antitoxin and collection of biomarker data is more possible than it would be in other anthrax-endemic countries with less developed healthcare infrastrucutre. Care is more consistent with US treatment protocols compared to treatment practices in many other anthrax-endemic countries.

C. 3 – SCOPE OF WORK

A new pilot study of anthrax cases will be initiated to evaluate the objectives listed above, namely to evaluate the use of anthrax antitoxin, to identify potential risk factors for severe disease, and to collect a strain library to evaluate resistance patterns in these strains.

Patients presenting with anthrax at the Osh Regional Hospital during the study enrollment period will be invited to participate in the study. Following receipt of informed consent, participating patients will be administered the risk factor questionnaire and have blood collected to test for the set list of biomarkers. Patients who are eligible for antitoxin, or their designated proxies, will also be invited to participate in the antitoxin sub-study.

The USG will set parameters to achieve the specified goals and objectives described here. The USG will also develop drafts of the patient assessment protocol, patient consent forms, risk factor questionnaire, chart abstraction tools, blood collection protocol, and the isolate storage protocol for review and input from the contractor. The USG will provide biomarker recommendations for testing and get input from the contractor; once biomarkers are selected and patients are enrolled, the contractor shall coordinate testing of the biomarkers specified in the protocol.

USG will submit the protocol to CDC’s Human Research Protection Office for ethics review following IRB approval by the International School of Medicine’s IRB has granted approval. Additionally, the USG will provide the contractor with anthrax antitoxin, and will provide feedback and suggestions on any issues that arise as reported in the Quarterly Reports or during other communications.

C. 4 – TASKS

4.1 Contractor shall expand on the draft Risk Factor questionnaire provided by USG and finalize the form to capture at least the following minimum information from eligible, enrolled patients:

Demographics (e.g., age, sex, religion, region and raion of residence, occupation), social history and socioeconomic status (e.g., alcohol and tobacco use, nutrition, household wealth), medical history (e.g., chronic conditions, medications, prior anthrax infections), source of possible Bacillus anthracis exposure, and symptoms of their current infection.

4.2 Contractor shall expand on the draft chart abstraction tool to capture at least the following minimum standard-of-care Risk Factor biomarkers and conditions for all eligible cases who are enrolled:

History of chronic conditions, including obesity, hypertension, chronic obstructive pulmonary disease, diabetes, and hepatitis; iron status (transferrin, iron, ferritin, total iron binding capacity); measures of chronic oxidative stress; complete blood count; c-reactive protein; gamma-glutamyl transferase; albumin; bilirubin;

hepatitis B surface antigen; antibodies to hepatitis C (anti-HCV Ab); blood urea nitrogen; serum creatinine;

SaO2; hemoglobin A1c (Hgb A1c); and anthrax diagnostic results.

Additional biomarkers that are not part of the standard-of-care may be included:

Additional tests to be done at a diagnostic lab may include: cotinine, carboxyhemoglobin, carbohydrate-deficient transferrin, measures of genetic causes of iron overload (HC-1, HC-2A, HC-2B, HC-3, and HC-4), hemoglobin electrophoresis, urinary arsenic, and plasma protein carbonyl component (ePCO).

4.3 Contractor shall expand on the draft template chart abstraction tool to capture at least the following minimum information on any antitoxin recipients. Decisions on inclusion of data elements will be based on local standard of care, feasibility, and prioritization by anthrax experts.

Data elements may include: demographics, sequential organ failure assessment (SOFA) scores, chief complaint, treatments received, as well as elements related to antitoxin administration (e.g., time of antitoxin administration, infusion rate, incidents or adverse events at time of administration), adverse events over 14 days and 30 days post-administration, and a final patient summary describing outcomes. The following areas are needed at specific time points for 14 days post-administration: specimens collected for laboratory testing;

vital signs and ventilator settings; chemistry, hematology, coagulation, and urinalysis with microscopy; and neurology, input and output, weight, chest x-ray, and total blood products per week.

4.4 Contractor shall develop blood collection protocol for Risk Factor biomarkers study to include times for collection, quantity and in what types of tubes collection will occur as appropriate for requested tests, where tests will be run, storage of specimens prior to testing, storage of specimens and method of shipment for specimens that will be sent to the Government for testing.

4.5 Contractor shall develop blood collection protocol for Antitoxin study to include times for collection (e.g., for serial testing related to antitoxin administration), quantity and in what types of tubes collection will occur as appropriate for requested tests, where tests will be run, storage of specimens prior to testing, storage of specimens and method of shipment for specimens that will be sent to the Government for testing.

4.6 Contractor shall develop isolate and specimen storage protocol.

4.7 Contractor shall develop form “Consent for Pilot Risk Factor Study: Part 1 (Questionnaire)”.

4.8 Contractor shall develop form “Consent for Pilot Risk Factor Study: Part II (Biomarkers)”.

4.9 Contractor shall develop form “Consent for Antitoxin Study”.

4.10 Contractor shall generate Quarterly Report 1 which includes a one pager with attachments to include documentation of successful hiring of research coordinator (4.1) and current drafts of materials (4.2 - 4.10).

4.11 Contractor shall submit materials to the International School of Medicine’s IRB for review.

4.12 Contractor shall submit materials for CDC Ethics review.

4.13 Contractor shall identify and enroll eligible patients for anthrax risk factor and antitoxin pilot study.

4.14 Contractor shall generate Quarterly Report 2 which includes a one pager with attachments to include current drafts of any new materials developed for project, documentation of approvals (4.12 and 4.13), as well as overview of enrolled patients (4.14) without any personally identfiable information (PII). This may include a line list comprising age, sex, occupation, date of hospitalization, severity (mild, moderate, severe), outcome, length of stay, and enrollment status.

4.15 Contractor shall generate Quarterly Report 3 which includes a one pager with attachments to include current drafts of any new materials developed for project as well as overview of enrolled patients (4.14) without any personally identfiable information (PII). This may include a line list comprising age, sex, occupation, date of hospitalization, severity (mild, moderate, severe), outcome, length of stay, and enrollment status.

4.16 Contractor shall generate Quarterly Report 4 which includes a one pager with attachments to include current drafts of any new materials developed for project as well as overview of enrolled patients (4.14) without any personally identfiable information (PII). This may include a line list comprising age, sex, occupation, date of

4.17 Contractor shall generate Quarterly Report 5 which includes a one pager with attachments to include current drafts of any new materials developed for project as well as overview of enrolled patients (4.14) without any personally identfiable information (PII). This may include a line list comprising age, sex, occupation, date of

4.18 Contractor shall generate Quarterly Report 6 which includes a one pager with attachments to include current drafts of any new materials developed for project as well as overview of enrolled patients (4.14) without any personally identfiable information (PII). This may include a line list comprising age, sex, occupation, date of

4.19 Contractor shall generate Quarterly Report 7 which includes a one pager with attachments to include current drafts of any new materials developed for project as well as overview of enrolled patients (4.14) without any personally identfiable information (PII). This may include a line list comprising age, sex, occupation, date of

4.20 Contractor shall draft Pilot Study Overview summarizing the results of the pilot study, to include at a minimum age, sex, occupation, date of hospitalization, severity (mild, moderate, severe), outcome, length of stay, enrollment status for Pilot Risk Factor Study Parts 1 and 2 and for Antitoxin Study, and conclusions.

4.21 Contractor shall collect and store serum aliquots from patients and B. anthracis isolates and ship to the

Government upon completion of pilot study.

4.22 Contractor shall establish unique identifiers for each participating patient to link all the study questionnaires, chart abstractions, and laboratory results. Procedures will be discussed with the contractor during protocol development, and procedures will be included in the protocol. The information collected from the first two components of the study will be analyzed and results will be disseminated to the scientific community in the form of at least one presentation and/or manuscript. USG may provide technical assistance with analysis and writing, if requested by the contractor. If data is shared with USG for technical assistance, data will be de-identified.

4.23 Contractor shall perform antimicrobial susceptibility testing on all strains, and store and ship the strains to the

US. The USG will perform the whole genome sequencing and broth microdilution on the collected strains and will provide the contractor with the results of the analysis. USG will lead the write up of an associated manuscript, if applicable.

C. 5 - DELIVERABLES

The items specified for delivery are subject to the inspection and acceptance by contracting officer’s representative.

The Contractor shall provide the following as Deliverables by the due dates specified below. Unless another language is specifically requested, all deliverables shall be submitted electronically and in English

Task Number

Deliverable Format Due Date Deliver To

Task 4.1 Risk Factor questionnaire

Electronic email 1 August 2022 COR, CO, and Project

Manager

Task 4.7 Consent form for Pilot Risk Factor Study, Part

Electronic Email 15 August 2022 COR, CO, and Project

Manager

Task 4.8 Consent form for Pilot Risk Factor Study, Part

II

Electronic Email 1 September 2022 COR, CO, and Project

Manager

Task 4.10 Consent form for Antitoxin Study

Electronic Email 15 September 2022 COR, CO, and Project

Manager

Task 4.10 Quarterly Report 1 Electronic email

01 October 2022 COR, CO, and Project

Task 4.14 Quarterly Report 2 Electronic email

1 January 2023

Task 4.15 Quarterly Report 3 Electronic email

1 April 2023

Task 4.16 Quarterly Report 4 Electronic email

1 July 2023

Task 4.17 Quarterly Report 5 Electronic email

1 October 2023

Task 4.18 Quarterly Report 6 Electronic email COR, CO, and Project

1 January 2024 Manager

Task 4.19 Quarterly Report 7 Electronic email

1 April 2024

Task 4.20 Pilot Study Overview Electronic email

1 July 2024 COR and Project

Manager

Task 4.21 Ship serum aliquots and isolates to CDC

Secure physical shipment

1 August 2024

COR and Project

C. 6 - GOVERNMENT FURNISHED MATERIALS

Antitoxin

USG will provide the Contractor with 10 treatment courses of anthrax antitoxin no later than August 20, 2022, and will provide feedback and suggestions on any issues that arise as reported in the Quarterly Reports.

Protocol, Methodology, and Procedures

USG will provide materials documenting protocol, methodology, and procedures to guide Contractor in development of research materials within one week after contract award.

C. 7 – PLACE OF PERFORMANCE

All work associated with this contract will be performed at Contractor’s facility.

C. 8 – TRAVEL

No travel is anticipated under this contract.

C. 9 – PERFORMANCE REQUIREMENTS SUMMARY

Service Required

Measures of Success Indicators

Standards - Criteria for Acceptance

Method of Surveillance

Positive or Negative Incentives

All Tasks and Deliverables from Section 4 and 5

Contractor shall perform all tasks/services in accordance with (IAW) what is stated in section 4 and 5.

Timeliness –

(1) All tasks, reports, and deliverables completed within due date specified in Section 5.

100% of Services/tasks adhere to applicable requirements as stated in section 4.

100% of time –All tasks, reports, and deliverables shall be performed by due date specified in Section 5 unless delay is approved in advanced by COR.

COR

approval and observation

Positive: Past Performance and Evaluation will be used in determining awards for future contracts for similar services.

Negative: Performance evaluations will include any services that failed to meet acceptable standards and will be used in determining awards for future contracts for similar services.

FAR CLAUSES

FAR SOURCE TITLE AND DATE

52.204-13 System for Award Management Maintenance (Oct 2018) 52.204-18 Commercial and Government Entity Code Maintenance (AUG 2020) 52.232-39 Unenforceability of Unauthorized Obligations (Jun 2013) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Nov 2021)

HHSAR SOURCE

352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015)

FAR 52.213-4 - TERMS AND CONDITIONS—SIMPLIFIED ACQUISITIONS (OTHER THAN COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES) (JAN 2022)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses that are incorporated by reference:

(1) The clauses listed below implement provisions of law or Executive order:

(i) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN

2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(ii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (NOV 2021) (Section 1634 of Pub. L. 115-91).

(iii) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (NOV 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

(iv) 52.222-3, Convict Labor (JUN 2003) (E.O.11755).

(v) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

(vi) 52.222-26, Equal Opportunity (Sept 2016) (E.O.11246).

(vii) 52.225-13, Restrictions on Certain Foreign Purchases (FEB 2021) (E.O.s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

(viii) 52.233-3, Protest After Award (AUG 1996) ( 31 U.S.C.3553).

(ix) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Pub.L.108-77, 108-78 ( 19 U.S.C. 3805 note)).

(2) Listed below are additional clauses that apply:

(i) 52.232-1, Payments (APR 1984).

(ii) 52.232-8, Discounts for Prompt Payment (FEB 2002).

(iii) 52.232-11, Extras (APR 1984).

(iv) 52.232-25, Prompt Payment (JAN 2017).

(v) 52.232-39, Unenforceability of Unauthorized Obligations (JUN 2013).

(vi) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (NOV 2021).

(vii) 52.233-1, Disputes (MAY 2014).

(viii) 52.244-6, Subcontracts for Commercial Products and Commercial Services (JAN 2022).

(ix) 52.253-1, Computer Generated Forms (JAN 1991).

(b) The Contractor shall comply with the following FAR clauses, incorporated by reference, unless the circumstances do not apply:

(1) The clauses listed below implement provisions of law or Executive order:

(i) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020)(Pub.

L. 109-282) ( 31 U.S.C. 6101 note) (Applies to contracts valued at or above the threshold specified in FAR 4.1403(a) on the date of award of this contract).

(ii) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (JAN 2022) (E.O. 13126) (Applies to contracts for supplies exceeding the micro-purchase threshold, as defined in FAR 2.101 on the date of award of this contract).

(iii) 52.222-20, Contracts for Materials, Supplies, Articles, and Equipment., Contracts for Materials, Supplies, Articles, and Equipment (JUN 2020) ( 41 U.S.C.chapter 65) (Applies to supply contracts over the threshold specified in FAR 22.602 on the date of award of this contract, in the United States, Puerto Rico, or the U.S. Virgin Islands).

(iv) 52.222-35, Equal Opportunity for Veterans (JUN 2020) ( 38 U.S.C. 4212) (Applies to contracts valued at or above the threshold specified in FAR 22.1303(a) on the date of award of this contract).

(v) 52.222-36, Equal Employment for Workers with Disabilities (JUN 2020) ( 29 U.S.C. 793) (Applies to contracts over the threshold specified in FAR 22.1408(a) on the date of award of this contract, unless the work is to be performed outside the United States by employees recruited outside the United States). (For purposes of this clause, "United States" includes the 50 States, the District of Columbia, Puerto Rico, the Northern Mariana Islands, American Samoa, Guam, the U.S. Virgin Islands, and Wake Island.)

(vi) 52.222-37, Employment Reports on Veterans (JUN 2020) ( 38 U.S.C. 4212) (Applies to contracts valued at or above the threshold specified in FAR 22.1303(a) on the date of award of this contract).

(vii) 52.222-41, Service Contract Labor Standards (AUG 2018) ( 41 U.S.C. chapter 67) (Applies to service contracts over $2,500 that are subject to the Service Contract Labor Standards statute and will be performed in the United States, District of Columbia, Puerto Rico, the Northern Mariana Islands, American Samoa, Guam, the U.S. Virgin Islands, Johnston Island, Wake Island, or the outer Continental Shelf).

(viii) (A) 52.222-50, Combating Trafficking in Persons (NOV 2021) ( 22 U.S.C. chapter 78 and E.O.

13627) (Applies to all solicitations and contracts).

(B) Alternate I (MAR 2015) (Applies if the Contracting Officer has filled in the following information with regard to applicable directives or notices: Document title(s), source for obtaining document(s), and contract performance location outside the United States to which the document applies).

(ix) 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (JAN

2022) (Applies when 52.222-6 or 52.222-41 are in the contract and performance in whole or in part is in the United States (the 50 States, the District of Columbia, Puerto Rico, the Northern Mariana Islands, American Samoa, Guam, the U.S. Virgin Islands, Johnston Island, Wake Island, and the outer Continental Shelf as defined in the Outer Continental Shelf Lands Act (43 U.S.C. 1331, et seq.))).

(x) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2022) (E.O. 13706) (Applies when 52.222-6 or 52.222-41 are in the contract and performance in whole or in part is in the United States (the 50 States and the District of Columbia.))

(xi) 52.223-5, Pollution Prevention and Right-to-Know Information (MAY 2011) (E.O. 13423) (Applies to services performed on Federal facilities).

(xii) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (JUN 2016) (E.O. 13693)(applies to contracts for products as prescribed at FAR 23.804(a)(1)).

(xiii) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (JUN 2016) (E.O. 13693) (Applies to maintenance, service, repair, or disposal of refrigeration equipment and air conditioners).

(xiv) 52.223-15, Energy Efficiency in Energy-Consuming Products (MAY 2020) ( 42 U.S.C. 8259b) (Unless exempt pursuant to 23.204, applies to contracts when energy-consuming products listed in the ENERGY STAR® Program or Federal Energy Management Program (FEMP)) will be-

(A) Delivered;

(B) Acquired by the Contractor for use in performing services at a Federally-controlled facility;

(C) Furnished by the Contractor for use by the Government; or

(D) Specified in the design of a building or work, or incorporated during its construction, renovation, or maintenance).

(xv) 52.223-20, Aerosols (JUN 2016) (E.O. 13693) (Applies to contracts for products that may contain high global warming potential hydrofluorocarbons as a propellant or as a solvent; or contracts for maintenance or repair of electronic or mechanical devices).

(xvi) 52.223-21, Foams (JUN 2016) (E.O. 13693) (Applies to contracts for products that may contain high global warming potential hydrofluorocarbons or refrigerant blends containing hydrofluorocarbons as a foam blowing agent; or contracts for construction of buildings or facilities.

(xvii) 52.225-1, Buy American-Supplies (NOV 2021) ( 41 U.S.C. chapter 67) (Applies to contracts for supplies, and to contracts for services involving the furnishing of supplies, for use in the United States or its outlying areas, if the value of the supply contract or supply portion of a service contract exceeds the micro-purchase threshold, as defined in FAR 2.101 on the date of award of this contract, and the acquisition-

(A) Is set aside for small business concerns; or

(B) Cannot be set aside for small business concerns (see 19.502-2), and does not exceed $25,000).

(xviii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations., Promoting Excess Food Donation to Nonprofit Organizations (JUN 2020) ( 42 U.S.C. 1792) (Applies to contracts greater than the threshold specified in FAR 26.404 on the date of award of this contract, that provide for the provision, the service, or the sale of food in the United States).

(xix) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (OCT

2013)(Applies when the payment will be made by electronic funds transfer (EFT) and the payment office uses the System for Award Management (SAM) as its source of EFT information).

(xx) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (JUL 2013) (Applies when the payment will be made by EFT and the payment office does not use the SAM database as its source of EFT information).

(xxi) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (NOV 2021) ( 46 U.S.C. 55305)(Applies to supplies transported by ocean vessels (except for the types of subcontracts listed at 47.504(d)).

(2) Listed below are additional clauses that may apply:

(i) 52.204-21, Basic Safeguarding of Covered Contractor Information Systems (NOV 2021) (Applies to contracts when the contractor or a subcontractor at any tier may have Federal contract information residing in or transiting through its information system.)

(ii) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (NOV 2021) (Applies to contracts over the threshold specified in FAR 9.405- 2(b) on the date of award of this contract).

(iii) 52.211-17, Delivery of Excess Quantities (Sept 1989) (Applies to fixed-price supplies).

(iv) 52.247-29, F.o.b. Origin (FEB 2006) (Applies to supplies if delivery is f.o.b. origin).

(v) 52.247-34, F.o.b. Destination (NOV 1991) (Applies to supplies if delivery is f.o.b. destination).

(c) 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):

www.acquisition.gov http://www.hhs.gov/policies/hhsar/subpart301-1.html

(d) Inspection/Acceptance. The Contractor shall tender for acceptance only those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. The Government must exercise its postacceptance rights-

(1) Within a reasonable period of time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(e) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence, such as acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(f) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges that the Contractor can demonstrate to the satisfaction of the Government, using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor’s records. The Contractor shall not be paid for any work performed or costs incurred that reasonably could have been avoided.

(g) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(h) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(End of clause)

HHSAR 352.232-71 Electronic Submission of Payment Requests (Feb 2022)

(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)

CDC37.0001 Non-Personal Services (Jun 2020)

(a) Personal services shall not be performed under this contract. Although the Government may provide sporadic or occasional instructions within the scope of the contract, the Contractor is responsible for control and supervision of its employees. If the Contractor (including its employees) believes any Government action or communication has been given that would create a personal services relationship between the Government and any Contractor employee, the Contractor shall promptly notify the Contracting Officer of this communication or action.

(b) The contractor shall comply with, and ensure their employees and subcontractors comply with, CDC Policy titled "Contractor Identification and Safeguarding of Non-Public Information". No Contractor employee shall hold him or herself out to be a Government employee, agent, or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government. In all communications with third parties in connection with this contract, Contractor employees shall identify themselves as Contractor employees and specify the name of the company for which they work. The contractor is limited to performing the services identified in the contract statement of work and shall not interpret any communication with anyone as a permissible change in contract scope or as authorization to perform work not described in the contract. All contract changes will be incorporated by a modification signed by the Contracting Officer.

(c) The Contractor shall ensure that all of its employees and subcontractor employees working on this contract are informed of the terms and conditions herein. The Contractor agrees that this is a non-personal services contract; and that for all the purposes of the contract, the Contractor is not, nor shall it hold itself out to be an agent or partner of, or joint venture with, the Government. The Contractor shall notify its employees that they shall neither supervise nor accept supervision from Government employees. The substance of the terms herein shall be included in all subcontracts at any tier.

(d) The terms and conditions above do not limit the Government's rights under other terms of the contract, including those related to the Government's right to inspect and accept or reject the services performed under this contract.

(End of Clause)

Solicitation Provisions

This contract incorporates one or more provisions 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/browse/index/far

FAR SOURCE TITLE AND DATE

52.204-16 Commercial and Government Entity Code Reporting (Aug 2020) 52.204-7 System for Award Management (Oct 2018)

52.204-8 ANNUAL REPRESENTATIONS AND CERTIFICATIONS (JAN 2022)

(a) (1) The North American Industry Classification System (NAICS) code for this acquisition is 541715.

(2) The small business size standard is $16.5M.

(3) The small business size standard for a concern that submits an offer, other than on a construction or service acquisition, but proposes to furnish an end item that it did not itself manufacture, process, or produce is 500 employees if the acquisition—

(i)Is set aside for small business and has a value above the simplified acquisition threshold;

(ii)Uses the HUBZone price evaluation preference regardless of dollar value, unless the offeror waives the price evaluation preference; or

(iii)Is an 8(a), HUBZone, service-disabled veteran-owned, economically disadvantaged women-owned, or women-owned small business set-aside or sole-source award regardless of dollar value.

(b) (1) If the provision at 52.204-7, System for Award Management, is included in this solicitation, paragraph (d) of this provision applies.

(2) If the provision at 52.204-7, System for Award Management, is not included in this solicitation, and the Offeror has an active registration in the System for Award Management (SAM), the Offeror may choose to use paragraph (d) of this provision instead of completing the corresponding individual representations and certifications in the solicitation. The Offeror shall indicate which option applies by checking one of the following boxes:

(i) □ Paragraph (d) applies.

(ii) □ Paragraph (d) does not apply and the offeror has completed the individual representations and certifications in the solicitation.

(c) (1) The following representations or certifications in SAM are applicable to this solicitation as indicated:

(i) 52.203-2, Certificate of Independent Price Determination. This provision applies to solicitations when a firm-fixed-price contract or fixed-price contract with economic price adjustment is contemplated, unless–

(A) The acquisition is to be made under the simplified acquisition procedures in part 13;

(B) The solicitation is a request for technical proposals under two-step sealed bidding procedures; or

(C) The solicitation is for utility services for which rates are set by law or regulation.

(ii) 52.203-11, Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions. This provision applies to solicitations expected to exceed $150,000.

(iii) 52.203-18, Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements-Representation. This provision applies to all solicitations.

(iv) 52.204-3, Taxpayer Identification. This provision applies to solicitations that do not include the provision at 52.204-7, System for Award Management.

(v) 52.204-5, Women-Owned Business (Other Than Small Business). This provision applies to solicitations that-

(A) Are not set aside for small business concerns;

(B) Exceed the simplified acquisition threshold; and

(C) Are for contracts that will be performed in the United States or its outlying areas.

(vi) 52.204-26, Covered Telecommunications Equipment or Services-Representation. This provision applies to all solicitations.

(vii) 52.209-2, Prohibition on Contracting with Inverted Domestic Corporations-Representation.

(viii) 52.209-5, CertificationRegarding Responsibility Matters. This provision applies to solicitations where the contract value is expected to exceed the simplified acquisition threshold.

(ix) 52.209-11, Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law. This provision applies to all solicitations.

(x) 52.214-14, Place of Performance-Sealed Bidding. This provision applies to invitations for bids except those in which the place of performance is specified by the Government.

(xi) 52.215-6, Place of Performance. This provision applies to solicitations unless the place of performance is specified by the Government.

(xii) 52.219-1, Small Business Program Representations (Basic, Alternates I, and II). This provision applies to solicitations when the contract will be performed in the United States or its outlying areas.

(A) The basic provision applies when the solicitations are issued by other than DoD, NASA, and the Coast Guard.

(B) The provision with its Alternate I applies to solicitations issued by DoD, NASA, or the Coast Guard.

(C) The provision with its Alternate II applies to solicitations that will result in a multiple-award contract with more than one NAICS code assigned.

(xiii) 52.219-2, Equal Low Bids. This provision applies to solicitations when contracting by sealed bidding and the contract will be performed in the United States or its outlying areas.

(xiv) 52.222-22, Previous Contracts and Compliance Reports. This provision applies to solicitations that include the clause at 52.222-26, Equal Opportunity.

(xv) 52.222-25, Affirmative Action Compliance. This provision applies to solicitations, other than those for construction, when the solicitation includes the clause at 52.222-26, Equal Opportunity.

(xvi) 52.222-38, Compliance with Veterans’ Employment Reporting Requirements. This provision applies to solicitations when it is anticipated the contract award will exceed the simplified acquisition threshold and the contract is not for acquisition of commercial products or commercial services.

(xvii) 52.223-1, Biobased Product Certification. This provision applies to solicitations that require the delivery or specify the use of USDA–designated items; or include the clause at 52.223-2, Affirmative Procurement of Biobased Products Under Service and Construction Contracts.

(xviii) 52.223-4, Recovered Material Certification. This provision applies to solicitations that are for, or specify the use of, EPA–designated items.

(xix) 52.223-22, Public Disclosure of Greenhouse Gas Emissions and Reduction Goals-Representation. This provision applies to solicitations that include the clause at 52.204-7.)

(xx) 52.225-2, Buy American Certificate. This provision applies to solicitations containing the clause at 52.225-1.

(xxi) 52.225-4, Buy American-Free Trade Agreements-Israeli Trade Act Certificate. (Basic, Alternates I, II, and III.)

This provision applies to solicitations containing the clause at 52.225-3.

(A) If the acquisition value is less than $25,000, the basic provision applies.

(B) If the acquisition value is $25,000 or more but is less than $50,000, the provision with its Alternate I applies.

(C) If the acquisition value is $50,000 or more but is less than $92,319, the provision with its Alternate II applies.

(D) If the acquisition value is $92,319 or more but is less than $100,000, the provision with its Alternate III applies.

(xxii) 52.225-6, Trade Agreements Certificate. This provision applies to solicitations containing the clause at 52.225-5.

(xxiii) 52.225-20, Prohibition on Conducting Restricted Business Operations in Sudan-Certification. This provision applies to all solicitations.

(xxiv) 52.225-25, Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran-Representation and Certifications. This provision applies to all solicitations.

(xxv) 52.226-2, Historically Black College or University and Minority Institution Representation. This provision applies to solicitations for research, studies, supplies, or services of the type normally acquired from higher educational institutions.

(2) The following representations or certifications are applicable as indicated by the Contracting Officer:

[Contracting Officer check as appropriate.]

__ (i) 52.204-17, Ownership or Control of Offeror.

__ (ii) 52.204-20, Predecessor of Offeror.

__ (iii) 52.222-18, Certification Regarding Knowledge of Child Labor for Listed End Products.

__ (iv) 52.222-48, Exemption from Application…