A19 75D301-23-Q-76363.doc

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12 Rhesus Macaque Monkeys Federal contract opportunity
Solicitation number
75D301-23-Q-76363
Issued by
Department of Health and Human Services Centers for Disease Control and Prevention Office of Acquisition Services

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REQUEST FOR QUOTATIONS

(THIS IS NOT AN ORDER)

THIS RFQ

PAGE OF PAGES

1. REQUEST NO.

75D301-23-Q-76363

2. DATE ISSUED

06/15/2023

3. REQUISITION/PURCHASE REQUEST NO.

00HCVJCG-2023-74477

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) x

NAME
TELEPHONE NUMBER
AREA CODE
NUMBER
Christina Almond
(678)
475-4997 x
8. TO:
9. DESTINATION
a. NAME
b. COMPANY
a. NAME OF CONSIGNEE
c. STREET ADDRESS
b. STREET ADDRESS
c. CITY
d. CITY
e. STATE
f. ZIP CODE
d. STATE
e. ZIP CODE

10. PLEASE FURNISH QUOTATIONS TO

THE ISSUING OFFICE IN BLOCK 5a ON

OR BEFORE CLOSE OF BUSINESS (Date)

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.

11. SCHEDULE (Include applicable Federal, State and local taxes)

ITEM NO.

(a)

SUPPLIES/SERVICES

(b)

QUANTITY

(c)

UNIT

(d)

UNIT PRICE

(e)

AMOUNT

(f)

The Center for Disease Control and Prevention (CDC), National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Division of HIV Prevention, Laboratory Branch ) has a requirement to purchase 12 Rhesus Macaques.

Please submit a quotation to:

Christina Almond at TQV7@cdc.gov

No later than 2:00 PM EDT on 6/20/2023.

12. DISCOUNT FOR PROMPT PAYMENT
a. 10 CALENDAR DAYS

b. 20 CALENDAR DAYS

c. 30 CALENDAR DAYS

d. CALENDAR DAYS

NUMBER
PERCENTAGE

NOTE: Additional provisions and representations

13. NAME AND ADDRESS OF QUOTER
14. SIGNATURE OF PERSON AUTHORIZED TO

SIGN QUOTATION

15. DATE OF

QUOTATION

a. NAME OF QUOTER

b. STREET ADDRESS
16. SIGNER
a. NAME (Type or print)
b. TELEPHONE

c. COUNTY

AREA CODE

d. CITY
e. STATE
f. ZIP CODE
c. TITLE (Type or print)
NUMBER

AUTHORIZED FOR LOCAL REPRODUCTION

STANDARD FORM 18 (REV. 6-95)

Previous edition not usable

Prescribed by GSA

FAR (48 CFR) 53.215-1(a)

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B1. LINE ITEMS

ITEM
SUPPLIES / SERVICES
QTY / UNIT
UNIT PRICE
EXTENDED PRICE
0001
Rhesus Macaque Monkeys

This is a Firm-Fixed Price Line Item

Non-Severable Item

Period of Performance July 1, 2023 - July 31, 2024 Allotted time for medical screening and testing prior to delivery

12 Each
$
$
0002
Shipping and Handling
1 Each
$
$

B2. DELIVERY SCHEDULE

The contractor shall deliver 12 Rhesus Macaque Monkeys humanely and safely meeting all of the specifications listed in the Statement of Work to CDC, in Atlanta, GA. The contractor shall also deliver all testing and animal records as indicated in SECTION 7 – DELIVERABLES/REPORTING SCHEDULE.

B3. DELIVERY INFORMATION

The Contractor shall deliver all items described above to:

CDC Roybal Campus

1600 Clifton Road, NE, Building 23, Atlanta, GA 30329

Loading Dock

Point of Contact:

TBD

C. DESCRIPTION/SPECIFICATION/WORK STATEMENT

Statement of Work 12 Rhesus Macaques, Nonhuman primates for HIV prevention studies

Period of Performance: Delivery on or before 07/31/2024

SECTION 1 – BACKGROUND

The Centers for Disease Control and Prevention (CDC) Laboratory Branch supports the Division of HIV Prevention’s goals in HIV prevention as they pertain to clinical studies, viral transmission, diagnosis and incidence, intervention research with microbicides, vaccines, and chemoprophylaxis as well as investigates other human and zoonotic retroviruses. The lab conducts and develops multiple preclinical HIV intervention studies using nonhuman primate (NHP) models for HIV detection, quantitation, isolation, evolution, and surveillance including drug resistance.

SECTION 2 – PURPOSE

To purchase 12 Rhesus Macaques (Indian or Chinese-origin, male or female) for pharmacokinetic and efficacy studies of antiretroviral prophylaxis by the CDC, Deputy Director for Infectious Diseases (DDID), National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Division of HIV Prevention (DHP), Laboratory Branch.

SECTION 3 – SCOPE OF WORK

Independently, and not as an agent of the Government, the contractor shall provide all necessary trained personnel, transport cages, equipment, and materials to provide and deliver safely and humanely 12 Rhesus Macaques (Indian or Chinese origin) to the Centers for Disease Control and Prevention (CDC), DDID, NCHHSTP, DHP, Laboratory Branch.

The contractor’s facility must be licensed by the United States Department of Agriculture and accredited by AAALAC.

The contractor’s facility must be in compliance with the Animal Welfare Act and Regulations (Title 9 Code of Federal Regulations part 1), The Guide for the Care and Use of Laboratory Animals, and other federal policies and guidance as applicable that provide national standards for the acquisition, transportation, housing, control, maintenance, handling, treatment, care, use and disposal of macaques

The contractor transport company also must be USDA licensed as either a carrier or intermediate handler or, if a secondary subcontractor is used, a contract carrier. Per 2022 USDA regulations, the contractor shall provide a copy of their transport ‘contingency plan’ for review by the CDC Contracting Officer’s Representative (COR), CDC technical advisor, and CDC veterinarians.

The Contractor shall maintain its nonhuman primates in complex social and physical environments (other than during diagnostic testing or as clinically necessary for treatment) in order to provide behaviorally and medically healthy macaques.

The contractor shall provide detailed information on veterinary care and a description of any procedures that have been performed on the macaques. The Contractor shall send records of macaques to the COR and CDC veterinarian and maintain a copy for at least 3-years beyond the time of delivery/acquisition.

SECTION 4 – TASKS TO BE PERFORMED

Task 1.0 The contractor shall provide 12 Rhesus Macaques (of Indian or Chinese origin), meeting the following specifications:

1. Rhesus Macaques must be between the ages of 4 and 11 years. The Contractor shall provide proof of the date of birth for each primate to the COR.

2. The contractor shall ensure that all Rhesus Macaques shall have tested negative for tuberculosis (TB), tested for the presence of a measles antibody titer, tested negative for simian retroviruses (SRV) by polymerase chain reaction (PCR), tested for the presence of Macacine alphaherpesvirus 1, tested negative for antibodies to SRV, simian T-lymphotropic viruses (STLV), and simian immunodeficiency virus (SIV), been tested for the presence of internal and external parasites (include the testing modality used for internal parasitism and macaques shall have tested negative for Trichuris spp.), and tested negative by PCR for microbiology (e.g. Shigella, Campylobacter, Salmonella, Yersinia).

3. The contractor shall ensure that the macaques shall not have participated in prior studies with, or been exposed to HIV, SIV, SHIV, or other retrovirus studies prior to purchase by CDC.

4. All macaques must have a breeder’s statement and/or Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) export permits and declaration forms available. This must be provided to the COR and CDC veterinarian for each macaque.

5. All macaques must have been maintained in complex social and physical environments for behavioral and medical health.

6. All macaques shall have had no invasive surgical procedures except caesarian (females). Hysterectomized female macaques are not acceptable.

7. All female macaques shall have been confirmed NOT to be pregnant at the time of selection or shipment.

Note: CDC reserves the right to request further information based on the history of pathogens noted in macaque’s medical records and reserves the right to deny the selection of macaques based on the medical history and/or diagnostic testing. Additional testing may be required for animals who lived in or currently live in areas with known endemic pathogens of clinical concern (e.g. Coccidioides).

The Contractor shall perform the tasks specified below:

Task 1.1 To provide 12 healthy Rhesus Macaques (of Indian or Chinese origin), the Contractor shall identify 16 or more potential macaques meeting the specifications listed above and provide medical histories/records (see below for criteria) to the CDC for review for selection of 12 potential candidates and several alternates.

Medical History/records criteria:

a. Country, place, and date of origin

b. Macaque ID number (must match visible tattoo)

c. Date of birth and Sex

d. Most recent weights with dates obtained

e. Dates and results of all TB tests (all must be negative)

f. Dates, results, and external laboratory that performed testing for SIV, SRV, STLV, measles, internal and external parasites (including Trichuris spp.), and microbiology (e.g. Shigella, Campylobacter, Salmonella, Yersinia) must be negative by PCR.

g. Dates and results of Macacine alphaherpesvirus 1 (B virus) antibody test

h. Copies of all clinical records for each macaque since birth including any noted behavioral evaluations

i. Pair or group housing history when available, and all available behavioral/socialization information

j. All macaques shall have a breeder’s statement and/or CITES export permits and declaration forms.

k. Pregnancy and surgery history

l. Dates and results of pregnancy test (must not be pregnant)

Task 1.2. CDC will select 12 potential macaques and several alternate macaques that meet the specifications listed above and will notify the Contractor 2-4 weeks after receiving the complete medical records (from Task 1.1). Note: CDC reserves the right to request further information based on the history of pathogens noted in the macaque’s medical records and reserves the right to deny the selection of macaques based on the medical records/tests.

Task 2.0 Post potential selection Testing and Examination (potential 12 and several alternates)

Task 2.1. The Contractor shall perform the following testing and exam (“a” and “b” below), gather results and records, and send to CDC for further review and acceptability. If the COR or CDC veterinarian rejects a macaque for any reason after post-selection testing and examination, the contractor shall identify substitute candidates meeting the requirements and provide all documentation for the substituted macaque. The Contractor shall provide the actual paperwork of all results received from outside diagnostic laboratory testing to the COR technical representative and the CDC veterinarian.

a. Week 1, testing: start within 15 business days of the COR’s notification (described in Task 1.2)

i. First TB Test (Note: Three (3) tests required in all at two-week intervals, must be negative)

ii. Microbiology by PCR (eg. Shigella, Campylobacter, Salmonella, Yersinia, Ecoli, and Giardia)

iii. Ova and parasites (e.g. Trichuris and Cryptosporidium)

b. Week 3, testing and exam:

i. Second TB Test, two weeks after the first

ii. Measles, SIV, SRV, STLV, Macacine alphaherpesvirus (B virus) serology

iii. SRV type D PCR

Task 2.2 The Contractor shall perform the following testing and exam (“a” below), and provide results to the COR and CDC veterinarians. Medical exam records shall be gathered and sent to the CDC COR and CDC veterinarians upon completion.

a. Week 5, testing and exam:

iv. Third TB test, two weeks after the first

v. Microbiology by PCR (e.g. Shigella, Campylobacter, Salmonella, Yersinia, Ecoli (EAEC, EPEC, ETEC, STEC, EIEC), and giardia)

vi. Ova and parasites (e.g. Trichuris and Cryptosporidium)

vii. Physical exam requirement-- The Contractor’s veterinarian(s) shall perform physical exams (including the collection of blood for Complete Blood Count (CBC) and blood chemistry and urine for urinalysis) and weight determination with body condition scoring on the macaques.

1. (Note: Contractor’s Pre-delivery exam is also required 2-3 days prior to delivery date. See task 3.1)

Task 2.3 Within 7 business days of receiving the third TB, fecal examination for internal parasites, and microbiology by PCR (e.g. Shigella, Campylobacter, Salmonella, Yersinia) testing, provide records and results to the COR or CDC veterinarians. CDC will notify or further confirm to the Contractor of the post-selected/acceptability of the macaques and provide confirmation of selected macaques.

Note: If the COR or CDC veterinarian rejects a macaque for any reason after the third TB and second microbiology tests and the number remaining is less than 12, the contractor shall identify additional substitute/alternate candidate NHPs meeting the requirements and provide all documentation and testing for the substitution/alternate macaque (as specified in this statement of work). This replacement effort to screen additional macaques to bring the total to 12 shall not incur added cost to CDC.

Task 3.0 Delivery instruction for 12 rhesus macaques

After CDC’s notification (described in Task 2.3), the Contractor shall coordinate with CDC, the delivery of the final 12 selected/approved macaques. The delivery date must be within four weeks of the initial CDC notification (task 2.3). The Contractor’s transport company must be USDA licensed as either a carrier or intermediate handler or if a secondary subcontractor is used, a contract carrier. Per 2022 USDA regulations, the Contractor shall provide a copy of their transport ‘contingency plan’ for review by the COR and CDC veterinarians.

Task 3.1. Perform pre-delivery physical exams 2-3 days prior to the delivery date to ensure the safety and health of selected macaques. Prepare the exam records and send them to the CDC veterinarian before the delivery date of the macaques.

Task 3.2. The Contractor shall deliver the 12 Rhesus Macaques to the designated CDC Atlanta facility following the delivery requirement below:

a. Schedule an appointment for delivery not less than 7 days in advance of delivery by contacting the COR and CDC veterinarian.

b. Provide driver’s name and contact information at least 7 days prior to delivery, needed for security clearance at CDC. Driver(s) must be a US citizen(s).

c. Delivery shall be during CDC’s regular business hours: 9:00 AM to 3:00 PM, ideally Tuesday through Thursday, except on Federal holidays. The driver should notify the CDC COR or veterinarian when they are approximately 60 minutes from the facility. Special arrangements must be made prior to delivery if outside of regular business hours or if a delivery day might include a Monday or Friday.

d. Delivery Location: CDC, Roybal Campus, 1600 Clifton Road, NE, Building 23, Atlanta, GA 30329 (loading dock).

e. Upon delivery, the driver shall provide the original copy of USDA APHIS Form 7020 and associated shipping paperwork to fulfill regulatory requirements.

SECTION 5 – GOVERNMENT FURNISHED MATERIALS

None

SECTION 6 – PERIOD OF PERFORMANCE

Tasks should be performed to ensure that macaques can be delivered physically to CDC during 12 months. Delivery must occur as early as logistically possible and preferred delivery would be before or by July 31, 2024.

SECTION 7 – DELIVERABLES/REPORTING SCHEDULE

The contractor shall deliver humanely and safely 12 Female Pigtail macaques meeting all of the specifications listed above to CDC, Atlanta, GA. The contractor shall also deliver all testing and animal records as indicated above and below.

Items
Description
Quantity
Delivery Date
Deliver To
Report - Tasks1.0, 1.1
Prepare and send all records/medical history to CDC as a measure of CDC pre-screening
All available records in PDF format
Day 0-10
COR/CDC Vet
Report – Task 2.1a
TB test and microbiology test results
All available results in PDF format
Post-selection of potential macaques. Week 1 of testing
COR/CDC Vet
Report – Task 2.1b
Summary of testing described in Task 2.1a
All available results in PDF format
Week 3 of testing
COR/CDC Vet
Report - Tasks 2.2, 2.3
Summary of testing described in Task 2.2
All available results in PDF format text.
Week 5 of testing
COR/CDC Vet
Report -Task 3.1
Coordinate with CDC delivery of selected/ approved macaques. Perform pre-delivery exams and records.
Information on drivers for CDC security clearance approval. Records of pre-delivery exams in PDF format
Weeks 6-10
COR/CDC Vet
Animals - Task 3.2
Delivery of macaques to CDC
12 rhesus macaques (of Indian or Chinese origin)
Day of delivery
COR/CDC Vet
Records -Sections 3, 4
Maintain a copy of records of sent macaques
12 rhesus macaques (of Indian or Chinese origin)
0-3 years
N/A

SECTION 8 – REFERENCE MATERIALS

None

SECTION 9 – POINT OF CONTACT INFORMATION

The Point of Contact (POC) for this procurement is:

James Smith (Technical advisor)

Maderia Young-Toatley (COR) Centers for Disease Control and Prevention National Center for HIV, Hepatitis, STD, and TB Prevention Division of HIV Prevention, Laboratory Branch

1600 Clifton Road NE, Building 18, Room 2-134

Atlanta, Georgia 30329 Telephone Number: 404-639-1001

E-mail Address: CHK6@cdc.gov Preferred method of communication: email

SECTION 10 – MINIMUM VENDOR QUALIFICATIONS AND LEVEL OF EFFORT

The contractor should have the capacity, license, and insurance to provide and transport safely and treat humanely nonhuman primates and cages. Also, the contractor shall have or provide transportation company drivers that are US citizens for CDC security approval to access the CDC campus. To transport macaques, the contractor must be USDA licensed as either a carrier or intermediate handler or, if a secondary subcontractor is used, a contract carrier. Per 2022 USDA regulations, the contractor shall provide a copy of their transport ‘contingency plan’ for review by CDC COR, technical advisor, and veterinarians.

The Contractor shall have macaque facilities fully accredited by AAALAC.

The Contractor shall maintain its primates in complex social and physical environments in order to provide behaviorally and medically healthy macaques other than during diagnostic testing or as clinically necessary for treatment.

The contractor shall have no history of providing macaques that had been exposed to TB or tested positive to TB, SIV, SRV, and/or STLV, Shigella, Campylobacter, Salmonella, Yersinia, and/or pregnant (if females) to the DHAP Laboratory Branch in the past 15 years.

Principal Investigators (PIs) and Veterinarians shall have a minimum of 4 years of experience working with Non-human Primates.

The Contractor shall provide past performance history of selling Non-human Primates. The past performance history shall include no fewer than three (3) of the most recent contracts, preferably within the past five (5) years.

SECTION 12 – SPECIAL REQUIREMENTS

Electronic and Information Technology Accessibility Notice

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-aboard.gov/sec508/standards.htm.

(c) The Section 508 accessibility standards applicable to this contract are: 1194.

205 WCAG 2.0 Level A & AA Success Criteria

302 Functional Performance Criteria

502 Inoperability with Assistive Technology

504 Authoring Tools

602 Support Documentation

603 Support Services

In order to facilitate the Government's determination of whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and documentation detail - whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://hhs.gov/web/508.

In order to facilitate the Government's determination of whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(e) Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

SECTION D - SIMPLIFIED ACQUISITION TERMS AND CONDITIONS

E.1 CONTRACT CLAUSES

Clauses Incorporated by Reference

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)

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)
52.204-19
Incorporation by Reference of Representations and Certifications (Dec 2014)
52.212-4
Contract Terms and Conditions- Commercial Items (Dec 2022)
52.232-39
Unenforceability of Unauthorized Obligations (Jun 2013)

Clauses Incorporated In Full Text FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (Jun 2023)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

(1) 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)).

(2) 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).

(3) 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).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

(5) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) (31 U.S.C. 3903 and 10 U.S.C. 3801).

(6) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(7) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 ( 19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

[Contracting Officer check as appropriate.]

__ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Jun 2020), with Alternate I (Nov 2021) (41 U.S.C. 4704 and 10 U.S.C. 4655).

__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Nov 2021) (41 U.S.C. 3509)).

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

__ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jun 2020) (Pub. L. 109-282) ( 31 U.S.C. 6101 note).

__ (5) [Reserved].

__ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

__ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

__ (8) 52.204-27, Prohibition on a ByteDance Covered Application (Jun 2023) (Section 102 of Division R of Pub. L. 117-328).

__ (9) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Nov 2021) (31 U.S.C. 6101 note).

__ (10) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41 U.S.C. 2313).

__ (11) [Reserved].

__ (12) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Oct 2022) (15 U.S.C. 657a).

__ (13) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2022) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (14) [Reserved]

__ (15)

(i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2020) (15 U.S.C. 644).

__ (ii) Alternate I (Mar 2020) of 52.219-6.

__ (16)

(i) 52.219-7, Notice of Partial Small Business Set-Aside (Nov 2020) (15 U.S.C. 644).

__ (ii) Alternate I (Mar 2020) of 52.219-7.

__ (17) 52.219-8, Utilization of Small Business Concerns (Oct 2022) (15 U.S.C. 637(d)(2) and (3)).

__ (18)

(i) 52.219-9, Small Business Subcontracting Plan (Oct 2022) (15 U.S.C. 637(d)(4)).

__ (ii) Alternate I (Nov 2016) of 52.219-9.

__ (iii) Alternate II (Nov 2016) of 52.219-9.

__ (iv) Alternate III (Jun 2020) of 52.219-9.

__ (v) Alternate IV (Sep 2021) of 52.219-9.

__ (19)

(i) 52.219-13, Notice of Set-Aside of Orders (Mar 2020) (15 U.S.C. 644(r)).

__ (ii) Alternate I (Mar 2020) of 52.219-13.

__ (20) 52.219-14, Limitations on Subcontracting (Oct 2022) (15 U.S.C. 637s).

__ (21) 52.219-16, Liquidated Damages—Subcontracting Plan (Sep 2021) (15 U.S.C. 637(d)(4)(F)(i)).

__ (22) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Oct 2022) (15 U.S.C. 657f).

__ (23)

(i) 52.219-28, Post Award Small Business Program Rerepresentation (Mar 2023)(15 U.S.C. 632(a)(2)).

__ (ii) Alternate I (Mar 2020) of 52.219-28.

__ (24) 52.219-29, Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Oct 2022) (15 U.S.C. 637(m)).

__ (25) 52.219-30, Notice of Set-Aside for, or Sole-Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Oct 2022) (15 U.S.C. 637(m)).

__ (26) 52.219-32, Orders Issued Directly Under Small Business Reserves (Mar 2020) (15 U.S.C. 644(r)).

__ (27) 52.219-33, Nonmanufacturer Rule (Sep 2021) (15U.S.C. 637(a)(17)).

X(28) 52.222-3, Convict Labor (Jun 2003) (E.O.11755).

X (29) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Dec 2022) (E.O.13126).

X(30) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

X (31)(i) 52.222-26, Equal Opportunity (Sep 2016) (E.O.11246).

__ (ii) Alternate I (Feb 1999) of 52.222-26.

X(32)(i) 52.222-35, Equal Opportunity for Veterans (Jun 2020) (38 U.S.C. 4212).

__ (ii) Alternate I (Jul 2014) of 52.222-35.

X(33)(i) 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) (29 U.S.C. 793).

__ (ii) Alternate I (Jul 2014) of 52.222-36.

__ (34) 52.222-37, Employment Reports on Veterans (Jun 2020) (38 U.S.C. 4212).

X(35) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

X (36)(i) 52.222-50, Combating Trafficking in Persons (Nov 2021) (22 U.S.C. chapter 78 and E.O. 13627).

__ (ii) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

__ (37) 52.222-54, Employment Eligibility Verification (May 2022) (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial products or commercial services as prescribed in FAR 22.1803.)

__ (38)

(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA–Designated Items (May 2008) ( 42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (39) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O. 13693).

__ (40) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693).

__ (41)

(i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Oct 2015) of 52.223-13.

__ (42)

(i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (Jun 2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Jun2014) of 52.223-14.

__ (43) 52.223-15, Energy Efficiency in Energy-Consuming Products (May 2020) (42 U.S.C. 8259b).

__ (44)

(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (Oct 2015) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Jun 2014) of 52.223-16.

X (45) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun 2020) (E.O. 13513).

__ (46) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).

__ (47) 52.223-21, Foams (Jun2016) (E.O. 13693).

__ (48)(i) 52.224-3 Privacy Training (Jan 2017) (5 U.S.C. 552 a).

__ (ii) Alternate I (Jan 2017) of 52.224-3.

X(49)(i) 52.225-1, Buy American-Supplies (Oct 2022) (41 U.S.C. chapter 83).

__ (ii) Alternate I (Oct 2022) of 52.225-1.

__ (50)(i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (Dec 2022) (19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, 19 U.S.C. chapter 29 (sections 4501-4732), Public Law 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.

__ (ii) Alternate I [Reserved].

__ (iii) Alternate II (Dec 2022) of 52.225-3.

__ (iv) Alternate III (Jan 2021) of 52.225-3.

__ (v) Alternate IV (Oct 2022) of 52.225-3.

__ (51) 52.225-5, Trade Agreements (Dec 2022) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

__ (52) 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).

__ (53) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. Subtitle A, Part V, Subpart G Note).

__ (54) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

__ (55) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov2007) (42 U.S.C. 5150).

__ (56) 52.229-12, Tax on Certain Foreign Procurements (Feb 2021).

__ (57) 52.232-29, Terms for Financing of Purchases of Commercial Products and Commercial Services (Nov 2021) (41 U.S.C. 4505, 10 U.S.C. 3805).

__ (58) 52.232-30, Installment Payments for Commercial Products and Commercial Services (Nov 2021) (41 U.S.C. 4505, 10 U.S.C. 3805).

X (59) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct2018) (31 U.S.C. 3332).

__ (60) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) (31 U.S.C. 3332).

__ (61) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

__ (62) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

__ (63) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(13)).

__ (64)

(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Nov 2021) (46 U.S.C. 55305 and 10 U.S.C. 2631).

__ (ii) Alternate I (Apr 2003) of 52.247-64.

__ (iii) Alternate II (Nov 2021) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

[Contracting Officer check as appropriate.]

__ (1) 52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter67).

__ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ (3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) (Aug 2018) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ (4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (May 2014) ( 29U.S.C.206 and 41 U.S.C. chapter 67).

__ (5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May 2014) (41 U.S.C. chapter 67).

__ (6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (May 2014) (41 U.S.C. chapter 67).

__ (7) 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (Jan 2022).

__ (8) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2022) (E.O. 13706).

__ (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020) (42 U.S.C. 1792).

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, as defined in FAR 2.101, on the date of award of this contract, and does not contain the clause at 52.215-2, Audit and Records-Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e)

(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1), in a subcontract for commercial products or commercial services. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause-

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Nov 2021) (41 U.S.C. 3509).

(ii) 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)).

(iii) 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).

(iv) 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).

(v) 52.204-27, Prohibition on a ByteDance Covered Application (Jun 2023) (Section 102 of Division R of Pub. L. 117-328).

(vi) 52.219-8, Utilization of Small Business Concerns (Oct 2022) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds the applicable threshold specified in FAR 19.702(a) on the date of subcontract award, the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(vii) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

(viii) 52.222-26, Equal Opportunity (Sep 2015) (E.O.11246).

(ix) 52.222-35, Equal Opportunity for Veterans (Jun 2020) (38 U.S.C. 4212).

(x) 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) (29 U.S.C. 793).

(xi) 52.222-37, Employment Reports on Veterans (Jun 2020) (38 U.S.C. 4212).

(xii) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(xiii) 52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter 67).

(xiv)

(A) 52.222-50, Combating Trafficking in Persons (Nov 2021) (22 U.S.C. chapter 78 and E.O 13627).

(B) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

(xv) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May 2014) (41 U.S.C. chapter 67).

(xvi) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (May 2014) (41 U.S.C. chapter 67).

(xvii) 52.222-54, Employment Eligibility Verification (May 2022) (E.O. 12989).

(xviii) 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (Jan 2022).

(xix) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2022) (E.O. 13706).

(xx)

(A) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).

(B) Alternate I (Jan 2017) of 52.224-3.

(xxi) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. Subtitle A, Part V, Subpart G Note).

(xxii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xxiii) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) (31 U.S.C. 3903 and 10 U.S.C. 3801). Flow down required in accordance with paragraph (c) of 52.232-40.

(xxiv) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Nov 2021) (46 U.S.C. 55305 and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the Contractor may include in its subcontracts for commercial products and commercial services a minimal number of additional clauses necessary to satisfy its contractual obligations.

(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)

HHSAR 352.270-5b Care of Live Vertebrate Animals (December 18, 2015)

(a) Before undertaking performance of any contract involving animal-related activities where the species is regulated by the United Sates Department of Agriculture (USDA), the Contractor shall register with the Secretary of Agriculture of the United States in accordance with 7 U.S.C. 2136 and 9 CFR sections 2.25 through 2.28. The Contractor shall furnish evidence of the registration to the Contracting Officer.

(b) The Contractor shall acquire vertebrate animals used in research from a dealer licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR sections 2.1-2.11, or from a source that is exempt from licensing under those sections.

(c) The Contractor agrees that the care, use, and intended use of any live vertebrate animals in the performance of this contract shall conform with the Public Health Service (PHS) Policy on Humane Care of Use of Laboratory Animals (PHS Policy), the current Animal Welfare Assurance (Assurance), the Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC) and the pertinent laws and regulations of the United States Department of Agriculture (see 7 U.S.C. 2131 et seq. and 9 CFR subchapter A, Parts 1-4). In case of conflict between standards, the more stringent standard shall govern.

(d) If at any time during performance of this contract, the Contracting Officer determines, in consultation with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), that the Contractor is not in compliance with any of the requirements and standards stated in paragraphs (a) through (c) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer’s written notice of suspension, the Contracting Officer may, in consultation with OLAW, NIH, terminate this contract in whole or in part, and the Contractor’s name may be removed from the list of those contractors with Animal Welfare Assurances.

Note: The Contractor may request registration of its facility and a current listing of licensed dealers from the Regional Office of the Animal and Plant Health Inspection Service (APHIS), USDA, for the region in which its research facility is located. The location of the appropriate APHIS Regional Office, as well as information concerning this program, may be obtained by contacting the Animal Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737 (E-mail: ace@aphis.usda.gov; website: http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/animalwelfare).

(End of clause)

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

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.

2. does not include personal materials.

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

4. 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.

2. 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.

3. 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.

4. 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.

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