RFQ 75D301-20-Q-72597.pdf

REQUEST FOR QUOTATIONS

(THIS IS NOT AN ORDER) THIS RFQ IS X IS NOT A SMALL BUSINESS SET-ASIDE.

PAGE OF PAGES

1 23

1. REQUEST NO.

75D301-20-Q-72597

2. DATE ISSUED

9/2/2020

3. REQUISITION/PURCHASE REQUEST NO.

00HCVLBG-2020-48793

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

Sarah Turner (404) 498-5613 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)

Tilte: Fungal Biobank

Questions are due on or before – September 4, 2020 at 5pm Eastern

Quotations are due on or before –September 10, 2020 at 12:00pm Eastern (noon)

All questions and quotes must be emailed to

Contract Specialist Sarah Turner at kwp9@cdc.gov

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 are are not attached.

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)

7. DELIVERY

FOB

DESTINATION

OTHER

(See Schedule) mailto:kwp9@cdc.gov

Line Items

THIS IS A FIRM FIXED PRICE PURCHASE ORDER

PERIOD OF PERFORMANCE: 9/30/2020 – 9/29/2021

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

0001 Shipment Protocol

Protocol describing shipping logistics-includes frequency and method

1 Each

0002 Human Subjects Review

1 Each

0003 Specimen Data - Index (C&H)

Index Specimen - Coccidioides culture or histopathology positive speciemens

(minimum volume 2 ml)

50 Each

0004 Specimen Data- Pre-test (C&H)

Pre-test specimen - Coccidioides culture or histopathology positive speciemens

(minimum volume 2 ml)

50 Each

0005 Specimen Data - Convalescent convalescent - Coccidioides culture or histopathology positive speciemens

(minimum volume 2 ml)

50 Each

0006 Specimen Data-Index (ID & CF)

- Coccidioides immunodiffusion and/or complement fixation positve specimens

(minimum 2 ml)

150 Each

0007 Specimen Data - Pre-test (ID & CF)

Pre-test- Coccidioides immunodiffusion and/or complement fixation positve specimens (minimum 2 ml)

150 Each

0008 Specimen Data -Convalescent (ID & CF)

Convalescentt- Coccidioides immunodiffusion and/or complement fixation positve specimens (minimum 2 ml)

300 Each

75D301-20-Q-72198

Statement of Work

Title: Fungal Biobank

SECTION 1 – BACKGROUND

Building a robust biobank, a repository of biological samples and associated data, is important to advance understanding in new diagnostic technologies for coccidioidomycosis or Valley Fever (VF). VF is a fungal infection caused by inhalation of spores present in soil and dust in endemic areas of the western United States, Mexico, and Central and South America. VF is an important public health problem causing severe illness in some patients. During the past decade, hospitalization cost for VF totaled $2.2B in California alone and VF is one of the most common causes of pneumonia in high endemic regions. Various diagnostic techniques currently exist for VF; however, more information is needed to validate and evaluate performance of diagnostic technologies and to guide standardization of diagnostic techniques.

SUBSECTION A – DEFINITIONS

1. Biobank – a type of repository to store biological samples for future research.

2. Antigen - harmful substance which enters the body which causes the body to make antibodies as a response to fight off disease.

3. Antibodies - are substances that a person's or an animal's body produces in their blood in order to destroy substances that carry disease.

4. Metadata -a set of data that describes and gives information about other data

5. Index serum - serum specimen closest to culture or histopathology specimen positive for Coccidioides or serum specimen with first positive Immunodiffusion (ID) and/or Complement Fixation (CF) test

6. Pre-test serum - specimen that is 1–4 weeks before first positive Coccidioides test described in the previous sentence; preference to samples collected 2 weeks before positive test.

7. Convalescent serum specimen - specimen collected 1–8 weeks after first positive Coccidioides test, with preference to samples collected 4 weeks after positive test.

8. Immunodiffusion – a technique for detecting or measuring antibodies and antigens by their precipitation when diffused together through a gel or other medium.

9. Complement Fixation – a diagnostic test for antibody-antigen reaction to test for disease

SECTION 2 – PURPOSE

Vendor shall independently provide well-characterized de-identified fungal specimens for the purpose of CDC’s evaluation and validation of fungal diagnostic technologies.

SECTION 3 – SCOPE OF WORK

Vendor shall provide all necessary services, qualified personnel, materials, and equipment in order to (1) collect index serum samples from patients with culture- or histopathology-confirmed coccidioidomycosis collected within one week of positive culture/histopathology specimen collection, (2) collect index serum samples (at least 2 ml) from patients with acute pulmonary coccidioidomycosis and positive immunodiffusion or complement fixation testing, (3) collect pre-test and convalescent serum specimens (when available) for patients with index serum specimens, and (4) collect associated patient data (i.e., metadata).

SECTION 4 – TASKS TO BE PERFORMED

A. Establish a shipping process with logistics to send specimens to CDC (includes specimen shipping schedule)

B. Complete process for human subject review.

C. Complete credential processes for data entry personnel to gain access to the Secure Access

Management Services (SAMS).

D. Collect de-identified serum samples and associated metadata.

Breakdown of number of samples and associated metadata:

Index serum specimen (date of first positive immunodiffusion or complement fixation or serum specimen closest to date of positive culture or histopathology with Coccidioides)

Pre-test serum specimen (1–4 weeks before first positive Coccidioides test; preference to samples collected 2 weeks before positive test)

Convalescent serum specimen (1–8 weeks after first positive Coccidioides test; preference to samples collected 4 weeks after positive test)

Serum samples (at least 2 ml) from patients with positive Coccidioides culture or histopathology

50 patient specimens

1 specimen per patient, when available

1 specimen per patient, when available

Serum samples (at least 2 ml) from patients with positive Coccidioides immunodiffusion and/or complement fixation

150 patient specimens

1 specimen per patient, when available

2 specimen per patient, when available

E. Perform data entry into CDC provided REDCap for patient records.

F. Ship specimens to CDC; Sender pays for shipments

SECTION 5 – GOVERNMENT FURNISHED MATERIALS

N/A

SECTION 6 – PERIOD OF PERFORMANCE

The period of performance shall commence upon award of a purchase order and shall continue through the next 12 months and completed no later than September 30,2021.

SECTION 7 – PLACE OF PERFORMANCE

Vendor’s facilities

SECTION 8 – DELIVERABLES/REPORTING SCHEDULE

Vendor shall provide the following deliverables to the Contract Officer Representative (COR), Subject Matter

Expert (SME) and the Contract Officer by the dates reflected below.

Electronic files for the chart abstraction must be entered in REDCap.

Items Description Quantity or No.

of Copies

Delivery Date Deliver To

Shipment Protocol

Establish shipping protocol with logistics

1 On or before 30 days after award

COR, SME via email

Human Subject Review

Documentation of Human Subject approval

1 On or before 60 days after award

COR, SME via email

REDCap Data Entry

Entry of data to CDC REDCap

Per sample; see table below

On or before 365 days after award

COR and SME via REDCap

Coccidioides culture or histopathology positive specimens (minimum volume 2 ml)

Index sample Serum & data for culture or histopathology confirmed Cocci patient

50 On or before 365 days after award

COR, SME via email

Pre-test sample Serum & data for culture or histopathology confirmed Cocci patient

50 On or before 365 days after award

COR, SME via email

Convalescent sample

Serum & data for culture or histopathology confirmed Cocci patient

50 On or before 365 days after award

COR, SME via email

Coccidioides immunodiffusion and/or complement fixation positive specimens (minimum 2 ml)

Index sample Serum & data for positive Coccidioides immunodiffusion and/or complement fixation

150 On or before 365 days after award

COR, SME via email

Pre-test sample Serum & data for positive Coccidioides immunodiffusion and/or complement fixation

150 On or before 365 days after award

COR, SME via email

Convalescent sample

Serum & data for positive Coccidioides immunodiffusion and/or complement fixation

300 On or before 365 days after award

COR, SME via email

SECTION 9 – TRAVEL

N/A

SECTION 10 – SPECIAL REQUIREMENTS

Vendor is required to acquire SAMS access to enter data into CDC REDCap

SECTION 11 – Appendix A – REDCap variables

Demographics

1. Age

2. Sex

3. Race

4. Ethnicity

5. County and state of residence

6. Zip code

Medical conditions and outcome

1. Underlying medical conditions

2. Corticosteroid use

3. Hospitalized

a. Dates of hospitalization

4. Ever in ICU during hospitalization

a. Dates in ICU

5. List of recorded symptoms: ____________

6. Date of symptom onset

7. Any co-infection

a. Name of disease

8. Died within 30 days

Exposure and test information

1. Estimated exposure source, if known

a. Estimated date of exposure, if known

2. Date primary serum sample collected

3. Date of pre-test serum sample collection (1–4 weeks before first positive Coccidioides test;

preference to samples collected 2 weeks before positive test)

4. Date of convalescent serum sample collection (1–8 weeks after first positive Coccidioides test;

preference to samples collected 4 weeks after positive test)

5. Type of illness (e.g., acute pulmonary, chronic pulmonary, pulmonary nodule, disseminated, meningitis)

6. For patients with positive culture or histopathology

a. Date of positive culture/histopathology

b. Specimen body site

c. Coccidioides species, if known

7. For patients with positive Coccidioides immunodiffusion (ID) and/or complement fixation (CF)

a. Date of positive ID and/or CF

b. ID result

c. CF result

8. Other serologic testing

a. Results of Coccidioides enzyme immunoassay (EIA/ELISA) or lateral flow assay (if performed)

b. Results of Coccidioides antigen testing (if performed)

Treatment information

1. Antifungal treatment (if yes, specify drug, dose, and dates)

SECTION 12 – IT and Security Requirements

HHSAR Provision, 352.239-73: 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-board.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 503 Applications 504 Authoring Tools 602 Support Documentation 603 Support Services http://www.hhs.gov/web/508 http://www.access-board.gov/sec508/standards.htm

In order to facilitate the Government's determination 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 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.

Information Security and Privacy Compliance Requirements

The below information complies with CDC Security and Privacy compliance requirements for E-Government

Act of 2002 (FISMA 2002) and Federal Information Security Modernization Act of 2014 (FISMA 2014)

Security Compliance

Stardard-7: Generic Information Technology Security and Privacy Language

Safeguarding Information and Information Systems. In accordance with the Federal Information Processing

Standards Publication (FIPS)199, Standards for Security Categorization of Federal Information and Information

Systems, the Contractor (and/or any subcontractor) shall:

a. Protect government information and information systems in order to ensure: Confidentiality, which means preserving authorized restrictions on access and disclosure, based on the security terms found in this contract, including means for protecting personal privacy and proprietary information; Integrity, which means guarding against improper information modification or destruction, and ensuring information non- repudiation and authenticity; and Availability, which means ensuring timely and reliable access to and use of information.

b. Provide security for any Contractor systems, and information contained therein, connected to an

HHS network or operated by the Contractor on behalf of HHS regardless of location. In addition, if new or unanticipated threats or hazards are discovered by either the agency or contractor, or if existing safeguards have ceased to function, the discoverer shall immediately, within one (1) hour or less, bring the situation to the attention of the other party.

c. Adopt and implement the policies, procedures, controls, and standards required by the HHS

Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain the HHS Information Security Program security requirements, outlined in the

HHS Information Security and Privacy Policy (IS2P), by contacting the CO/COR or emailing fisma@hhs.gov.

http://hhs.gov/web/508 http://508.hhs.gov/ https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html mailto:fisma@hhs.gov

d. Comply with the Privacy Act requirements and tailor FAR clauses as needed.

Controlled Unclassified Information (CUI). CUI is defined as “information that laws, regulations, or

Government-wide policies require to have safeguarding or dissemination controls, excluding classified information.”

The Contractor (and/or any subcontractor) must comply with Executive Order 13556, Controlled Unclassified

Information, (implemented at 3 CFR, part 2002) when handling CUI. 32 C.F.R. 2002.4(aa) As implemented the term

“handling” refers to “…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, reusing, and disposing of the information.” 81 Fed. Reg. 63323. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, shall be:

a. marked appropriately;

b. disclosed to authorized personnel on a Need-To-Know basis;

c. protected in accordance with NIST SP 800-53, Security and Privacy Controls for Federal Information

Systems and Organizations applicable baseline if handled by a Contractor system operated on behalf of the agency, or NIST SP 800-171, Protecting Controlled Unclassified Information in Nonfederal

Information Systems and Organizations if handled by internal Contractor system; and

d. returned to HHS control, destroyed when no longer needed, or held until otherwise directed. Destruction of information and/or data shall be accomplished in accordance with NIST SP 800-88, Guidelines for

Media Sanitization.

Protection of Sensitive Information. For security purposes, information is or may be sensitive because it requires security to protect its confidentiality, integrity, and/or availability. The Contractor (and/or any subcontractor) shall protect all government information that is or may be sensitive in accordance with OMB Memorandum M-06-16, Protection of Sensitive Agency Information by securing it with a FIPS 140-2 validated solution.

Confidentiality and Nondisclosure of Information. Any information provided to the contractor (and/or any subcontractor) by HHS or collected by the contractor on behalf of HHS shall be used only for the purpose of carrying out the provisions of this contract and shall not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and shall ensure that all work performed by its employees and subcontractors shall be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any HHS records may be made available or disclosed shall be notified in writing by the

Contractor that information disclosed to such employee or subcontractor can be used only for that purpose and to the extent authorized herein. The confidentiality, integrity, and availability of such information shall be protected in accordance with HHS and CDC policies. Unauthorized disclosure of information will be subject to the HHS/CDC sanction policies and/or governed by the following laws and regulations:

a. 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records);

b. 18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information); and

c. 44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act).

Standard for Encryption. The Contractor (and/or any subcontractor) shall:

a. Comply with the HHS Standard for Encryption of Computing Devices and Information to prevent unauthorized access to government information.

b. Encrypt all sensitive federal data and information (i.e., PII, protected health information [PHI], proprietary information, etc.) in transit (i.e., email, network connections, etc.) and at rest (i.e., servers, storage devices, mobile devices, backup media, etc.) with FIPS 140-2 validated encryption solution.

c. Secure all devices (i.e.: desktops, laptops, mobile devices, etc.) that store and process government information and ensure devices meet HHS and CDC-specific encryption standard requirements. Maintain a complete and current inventory of all laptop computers, desktop computers, and other mobile devices and portable media that store or process sensitive government information (including PII).

d. Verify that the encryption solutions in use have been validated under the Cryptographic Module Validation

Program to confirm compliance with FIPS 140-2. The Contractor shall provide a written copy of the validation documentation to the COR upon request.

e. Use the Key Management system on the HHS personal identification verification (PIV) card or establish and use a key recovery mechanism to ensure the ability for authorized personnel to encrypt/decrypt information and recover encryption keys. Encryption keys shall be provided to the COR upon request and at the conclusion of the contract.

Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract shall complete the HHS/CDC non-disclosure agreement. A copy of each signed and witnessed NDA shall be submitted to the Contracting Officer (CO) and/or CO

Representative (COR) prior to performing any work under this acquisition.

Incident Response. A privacy breach is a type of incident and is defined by Federal Information Security

Modernization Act (FISMA) as the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where (1) a person other than an authorized user accesses or potentially accesses personally identifiable information (PII) or (2) an authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose. The HHS Policy for IT Security and Privacy Incident

Reporting and Response further defines a breach as “a suspected or confirmed incident involving PII”.

In the event of a suspected or confirmed incident or breach, the Contractor (and/or any subcontractor) shall:

1) Protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract so as to avoid a secondary sensitive information incident with FIPS 140-2 validated encryption.

2) NOT notify affected individuals unless so instructed by the Contracting Officer or designated representative. If so instructed by the Contracting Officer or representative, the Contractor shall send CDC approved notifications to affected individuals.

3) Report all suspected and confirmed information security and privacy incidents and breaches to the CDC

Incident Response Team (IRT) (CSIRT@cdc.gov, 866-655-2245), COR, CO, CDC SOP (or his or her designee), and other stakeholders, including incidents involving PII, in any medium or form, including paper, oral, or electronic, as soon as possible and without unreasonable delay, no later than one (1) hour, and consistent with the applicable CDC and HHS policy and procedures, NIST standards and guidelines, as well as US-CERT notification guidelines. The types of information required in an incident report must include at a minimum: company and point of contact information, contract information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor shall:

a. cooperate and exchange any information, as determined by the Agency, necessary to effectively manage or mitigate a suspected or confirmed breach;

b. not include any sensitive information in the subject or body of any reporting e-mail; and

c. encrypt sensitive information in attachments to email, media, etc.

4) Comply with OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable

Information and HHS/CDC incident response policies when handling PII breaches.

5) Provide full access and cooperate on all activities as determined by the Government to ensure an effective incident response, including providing all requested images, log files, and event information to facilitate rapid resolution of sensitive information incidents. This may involve disconnecting the system processing, storing, or transmitting the sensitive information from the Internet or other networks or applying additional security controls. This may also involve physical access to contractor facilities during a breach/incident investigation.

Sanitization of Government Files and Information. As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) shall provide documentation or attestation to the CO and/or COR to certify that, at the government’s direction, all electronic and paper records are appropriately disposed of and all devices and media are sanitized in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

Contractor Responsibilities Upon Physical Completion of the Contract. The contractor (and/or any subcontractors) shall return all government information and IT resources (i.e., government information in non-government-owned systems, media, and backup systems) acquired during the term of this contract to the CO and/or

COR. Additionally, the Contractor shall provide a certification that all government information has been properly sanitized and purged from Contractor-owned systems, including backup systems and media used during contract performance, in accordance with HHS and/or CDC policies.

Information Technology Application Design, Development, or Support.

1) The Contractor (and/or any subcontractor) shall ensure IT applications designed and developed for end users

(including mobile applications and software licenses) run in the standard user context without requiring elevated administrative privileges.

2) The Contractor (and/or any subcontractor) shall follow secure coding best practice requirements, as directed by United States Computer Emergency Readiness Team (US-CERT) specified standards and the Open Web

Application Security Project (OWASP), that will limit system software vulnerability exploits.

3) The Contractor (and/or any subcontractor) shall ensure that computer software developed on behalf of HHS or tailored from an open-source product, is fully functional and operates correctly on systems configured in accordance with government policy and federal configuration standards. The contractor shall test applicable products and versions with all relevant and current updates and patches updated prior to installing in the HHS environment. No sensitive data shall be used during software testing.

4) The Contractor (and/or any subcontractor) shall protect information that is deemed sensitive from unauthorized disclosure to persons, organizations or subcontractors who do not have a need to know the mailto:CSIRT@cdc.gov information. Information which, either alone or when compared with other reasonably-available information, is deemed sensitive or proprietary by HHS shall be protected as instructed in accordance with the magnitude of the loss or harm that could result from inadvertent or deliberate disclosure, alteration, or destruction of the data. This language also applies to all subcontractors that are performing under this contract.

Contracting Officer’s Representative (COR)

The (COR) will be identified by separate letter. The COR monitors all technical aspects of the contract and assists in contract administration The COR is authorized to perform the following functions: assure that the Contractor performs the technical requirements of the contract: perform inspections necessary in connection with contract performance: maintain written and oral communications with the Contractor concerning technical aspects of the contract: issue written interpretations of technical requirements, including Government drawings, designs, specifications: monitor Contractor's performance and notifies both the Contracting Officer and Contractor of any deficiencies; coordinate availability of government furnished property, and provide site entry of Contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the Contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order.

48 CFR 1552.237-76 GOVERNMENT-CONTRACTOR RELATIONS (JUN 1999)

(a) The Government and the Contractor understand and agree that the services to be delivered under this contract by the contractor to the Government are non-personal services and the parties recognize and agree that no employer-employee relationship exists or will exist under the contract between the Government and the Contractor's personnel. It is, therefore, in the best interest of the Government to afford both parties a full understanding of their respective obligations.

(b) Contractor personnel under this contract shall not:

(1) Be placed in a position where they are under the supervision, direction, or evaluation of a Government employee.

(2) Be placed in a position of command, supervision, administration or control over Government personnel, or over personnel of other Contractors under other EPA contracts, or become a part of the Government organization.

(3) Be used in administration or supervision of Government procurement activities.

(c) Employee relationship.

(1) The services to be performed under this contract do not require the Contractor or his/her personnel to exercise personal judgment and discretion on behalf of the Government. Rather the Contractor's personnel will act and exercise personal judgment and discretion on behalf of the Contractor.

(2) Rules, regulations, directives, and requirements that are issued by the U.S. Environmental Protection Agency under its responsibility for good order, administration, and security are applicable to all personnel who enter the

Government installation or who travel on Government transportation. This is not to be construed or interpreted to establish any degree of Government control that is inconsistent with a non-personal services contract.

(d) Inapplicability of employee benefits. This contract does not create an employer-employee relationship.

Accordingly, entitlements and benefits applicable to such relationships do not apply.

(1) Payments by the Government under this contract are not subject to Federal income tax withholdings.

(2) Payments by the Government under this contract are not subject to the Federal Insurance Contributions Act.

(3) The Contractor is not entitled to unemployment compensation benefits under the Social Security Act, as amended, by virtue of performance of this contract.

(4) The Contractor is not entitled to workman's compensation benefits by virtue of this contract.

(5) The entire consideration and benefits to the Contractor for performance of this contract is contained in the provisions for payment under this contract.

(e) Notice. It is the Contractor's, as well as, the Government's responsibility to monitor contract activities and notify the Contracting Officer if the Contractor believes that the intent of this clause has been or may be violated.

(1) The Contractor should notify the Contracting Officer in writing promptly, within (to be negotiated and inserted into the basic contract at contract award) calendar days from the date of any incident that the Contractor considers to constitute a violation of this clause. The notice should include the date, nature and circumstance of https://www.law.cornell.edu/topn/federal_insurance_contributions_act https://www.law.cornell.edu/topn/old_age_pension_act the conduct, the name, function and activity of each Government employee or Contractor official or employee involved or knowledgeable about such conduct, identify any documents or substance of any oral communication involved in the conduct, and the estimate in time by which the Government must respond to this notice to minimize cost, delay or disruption of performance.

(2) The Contracting Officer will promptly, within (to be negotiated and inserted into the basic contract at contract award) calendar days after receipt of notice, respond to the notice in writing. In responding, the

Contracting Officer will either:

(i) Confirm that the conduct is in violation and when necessary direct the mode of further performance,

(ii) Countermand any communication regarded as a violation,

(iii) Deny that the conduct constitutes a violation and when necessary direct the mode of further performance;

or

(iv) In the event the notice is inadequate to make a decision, advise the Contractor what additional information is required, and establish the date by which it should be furnished by the Contractor and the date thereafter by which the Government will respond.

PROVISIONS AND 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 (Jul 2016)

52.212-4 Contract Terms and Conditions- Commercial Items (Oct 2018)

52.232-39 Unenforceability of Unauthorized Obligations (Jun 2013)

52.232-40 Providing Accelerated Payments to Small Business Contractors (Dec 2013)

HHSAR SOURCE TITLE AND DATE

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

352.239-74 Electronic and Information Technology Accessibility (Dec 2015)

FAR 52.252-1 Solicitation Provisions Incorporated by Reference (Feb 1998)

This solicitation incorporates one or more solicitation 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. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

https://www.acquisition.gov

(End of provision)

FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-

Commercial Items (Aug 2020)

(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 items:

(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 (Jul 2018) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or

Equipment. (Aug 2020) (Section 889(a)(1)(A) of Pub. L. 115-232).

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

(5) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(6) 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 items:

[Contracting Officer check as appropriate.] http://www.acquisition.gov/ http://www.acquisition.gov/ https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_203-19 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#id189A70O0P1N https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#unique_1605198408 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1062680 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1048661 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1048698 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3

__ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (June 2020), with Alternate I (Oct

1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Jun 2020) (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.)

_X_ (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).

_X_ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Jun 2020) (31 U.S.C. 6101 note).

__ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018)

(41 U.S.C. 2313).

__ (10) [Reserved].

__ (11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Mar 2020) (15 U.S.C. 657a).

__ (ii) Alternate I (Mar 2020) of 52.219-3.

__ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Mar 2020)

(if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (ii) Alternate I (Mar 2020) of 52.219-4.

__ (13) [Reserved]

__ (14) (i) 52.219-6, Notice of Total Small Business Set-Aside (Mar 2020) of 52.219-6 (15 U.S.C. 644).

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

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

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

__ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).

__ (17) (i) 52.219-9, Small Business Subcontracting Plan (Jun 2020) (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 (Jun 2020) of 52.219-9

__ (18) (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.

__ (19) 52.219-14, Limitations on Subcontracting (Mar 2020) (15 U.S.C. 637(a)(14)).

__ (20) 52.219-16, Liquidated Damages-Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1063319 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1063504 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1063607 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1064087 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section6101&num=0&edition=prelim https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1064214 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1064243 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1062590 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section6101&num=0&edition=prelim https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1062651 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-section2313&num=0&edition=prelim https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057314 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section637a&num=0&edition=prelim https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057314 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057352 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057352 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057393 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057393 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057393 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057419 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057419 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_219-8 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_219-9 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_219-9 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_219-9 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_219-9 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_219-9 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057715 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057715 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057730 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057758

__ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Mar 2020)

(15 U.S.C. 657f).

_X_ (22) (i) 52.219-28, Post Award Small Business Program Rerepresentation (May 2020)

(15 U.S.C. 632(a)(2)).

(ii) Alternate I (MAR 2020) of 52.219-28.

__ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-

Owned Small Business Concerns (Mar 2020) (15 U.S.C. 637(m)).

__ (24) 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 (Mar2020) (15 U.S.C. 637(m)).

__ (25) 52.219-32, Orders Issued Directly Under Small Business Reserves (Mar 2020) (15 U.S.C. 644(r)).

__ (26) 52.219-33, Nonmanufacturer Rule (Mar 2020) (15U.S.C. 637(a)(17)).

_X_ (27) 52.222-3, Convict Labor (Jun 2003) (E.O.11755).

__ (28) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan2020) (E.O.13126).

_X_ (29) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

_X_ (30) (i) 52.222-26, Equal Opportunity (Sep 2016) (E.O.11246).

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

_X_ (31) (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_ (32) (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.

_X_ (33) 52.222-37, Employment Reports on Veterans (Jun 2020) (38 U.S.C. 4212).

__ (34) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O.

13496).

_X_ (35) (i) 52.222-50, Combating Trafficking in Persons (Jan 2019) (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).

__ (36) 52.222-54, Employment Eligibility Verification (Oct 2015). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

__ (37) (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.)

__ (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun

2016) (E.O. 13693).

__ (39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners

(Jun 2016) (E.O. 13693).

__ (40) (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.

__ (41) (i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (Jun 2014) (E.O.s 13423 and 13514).

https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057823 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057874 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057874 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057902 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057947 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.govinfo.gov/content/pkg/USCODE-2018-title15/html/USCODE-2018-title15-chap14A-sec644.htm https://www.govinfo.gov/content/pkg/USCODE-2018-title15/html/USCODE-2018-title15-chap14A-sec637.htm https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1055332 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1055664 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1055713 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1055793 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1055793 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1056230 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section4212&num=0&edition=prelim https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1056230 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1056250 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title29-section793&num=0&edition=prelim https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1056250 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1056265…