Amendment 1 to Attachment 1 Domain 1 Sample RFTOP SOO .pdf

ATTACHMENT 1 SAMPLE TASK ORDER DOMAIN 1

AMENDMENT 1

DOMAIN 1- Sample RFTOP

SOO Title: Surveillance for Non-Ventilator Hospital-Acquired Pneumonia using Electronic Clinical Data

Multiple task orders may be awarded subject to availability of funds and contractors should prepare technical proposals that are priced in the range of $140,000.00 - $180,000.00 BASE and $75,000.00 - $94,000.00 OPTION in order to be considered for award.

Proposed Period of Performance: This award will include a base period of 24 months, and one 12-month option period.

Work for the base period shall begin from date of award of the order and shall continue for a period of 24 months. This is a non-severable project. The Base period will be funded fully at the time of award. Funding for option periods will be subject to availability of funds.

PROPOSAL PREPARATION AND SUBMISSION

1. General Instructions: Offeror(s) shall submit proposals consisting of the following volumes:

Technical Proposal – Volume I Business Proposal – Volume II

a. Technical Proposal-Volume I

Technical Proposal Preparation Instructions – Page limit is (10) single-spaced pages of text for the technical proposal; (the page limit does not include appendices or resumes). Each volume in the proposal shall include a copy of the cover letter (letter of transmittal), title page and table of contents. The table of contents shall list sections, subsections and page numbers.

The technical proposal should be in as much detail as you consider necessary to reflect a clear understanding of the nature of the work being undertaken.

The technical proposal must NOT contain reference to cost; however, resource information, such as data concerning labor hours and categories, material, subcontracts, etc., must be contained in the technical proposal so that your understanding of the statement of work can be evaluated.

b. Business Proposal-Volume II

Pricing Narrative: The Offeror shall provide an explanation and/or detailed information on how the fully loaded labor rates were derived. The business proposal shall be an Excel spreadsheet, with an itemized price breakout per task for each period (e.g. Base Year, Option Years), including itemized prices for any subcontracted work. Proposed labor hours, labor costs, travel and other direct costs for this task order request shall be organized around the tasks and related deliverables described herein.

Pricing Worksheet: Utilizing the format in Attachment 11 of RFP, provide all applicable labor categories, descriptions, and rates, travel for the Prime Contractor/Subcontractor for each period (e.g. Base Year, Option Years).

Please return Section B (CLIN and payment milestone) with Business Proposal.

ATTACHMENT 1 SAMPLE TASK ORDER DOMAIN 1

SECTION B SUPPLIES OR SERVICES AND PRICES/COSTS

BASE PERIOD

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT

PRICE

EXTENDED

PRICES

0001 Safety and Healthcare Epidemiology Prevention Research Development (SHEPheRD) Program 2021 Domain 1 Surveillance for Non-Ventilator Hospital-Acquired Pneumonia using Electronic Clinical Data

POP: 24 months from award This is a Firm-Fixed Price and Non-Severable Line Item

1 Job $________ $ ___________

OPTION PERIOD ONE

ITEM SUPPLIES / SERVICES QTY /

UNIT

UNIT

PRICE

EXTENDED

PRICES

1001 Safety and Healthcare Epidemiology Prevention Research Development (SHEPheRD) Program 2021 Domain 1 Surveillance for Non-Ventilator Hospital-Acquired Pneumonia using Electronic Clinical Data

POP: 12 months from award This is a Firm-Fixed Price and Non-Severable Line Item

1 Job $________ $ ___________

**The offeror requires to identify the zip code of the work site so the appropriate wage determination can be identified and included with an awarded task order.

B.1 PAYMENT TERMS

Payment will be made subject to receipt of deliverables in accordance with the payment schedule established herein and in accordance with FAR 52.232-25. Prompt Payment, which states that the due date for making invoice payments shall be the 30th day after the designated billing office (see block 21 of the order) has received a proper invoice from the vendor or the 30th day after Government acceptance of the services provided by the vendor, whichever is later.

B.2 Schedule of Milestones for Performance-Based Payments In accordance with FAR 52.232-32, PERFORMANCE BASED PAYMENTS (April 2012), upon successful completion of an event, the contractor may request performance based payments. The determination of eligibility for receipt of payment will be made by the Contracting Officer upon written certification from the Contracting Officer’s Representative (COR) that the performance milestone has been met. It is anticipated that each milestone payment will approximate the estimated timeline listed below but variation is anticipated and eligibility for payment could occur sooner or later depending upon the time of completion of the designated milestone.

Milestone payments are subject to the terms of FAR 52.232-32 incorporated in this contract.

The COR receiving and acceptance of monthly performance based payments is based on verification that work on the contract was satisfactorily performed during the month and that, at a minimum, the following activities were satisfactorily performed.

ATTACHMENT 1 SAMPLE TASK ORDER DOMAIN 1

CONTRACTOR PROPOSED

MILESTONE EVENT PAYMENT %* DOLLAR AMOUNT

TOTAL 100 % $

*Milestone event payments may be allocated on a periodic basis as long as a completed event is associated with that payment.

ATTACHMENT 1 SAMPLE TASK ORDER DOMAIN 1

NOTE: Offerors are responsible for creating and submitting a Statement of Work (SOW) based upon the below Statement of Objectives. The Government will incorporate the successful offeror's SOW into the resulting contract. See Evaluation Criteria: SOW Requirements.

OVERVIEW: Hospital-acquired pneumonia (HAP) is the most common healthcare-associated infection in U.S. hospitals, and approximately 60% of HAP events are not associated with mechanical ventilation. An evaluation done by CDC staff in collaboration with the Pennsylvania Department of Health and eight hospitals showed that mortality was approximately 30% among adult patients who met the National Healthcare Safety Network surveillance definition for non-ventilator-associated HAP (NV-HAP) (See, I, et al. 2016). Furthermore, pneumonia is an important driver of antimicrobial use in hospitals. Unlike ventilator-associated pneumonia, which has been a focus of surveillance and prevention efforts in hospitals for decades, there is no national tracking of NV-HAP, and the optimal approach to NV-HAP surveillance and prevention is not well established.

Reference:

See I, et al. Infect Control Hosp Epidemiol 2016 Jul;37(7):818-24. doi: 10.1017/ice.2016.74.

Clinical Correlates of Surveillance Events Detected by National Healthcare Safety Network Pneumonia and Lower Respiratory Infection Definitions-Pennsylvania, 2011-2012

PROJECT GOALS: CDC seeks proposals that develop and/or evaluate alternative surveillance definitions for NV-HAP that make use of data commonly available in electronic health records (i.e., other than NHSN definitions or administrative code-based approaches), that could be potentially automatable. Specifically, the objectives of the work will be: 1) develop a pilot Electronic Health Record (EHR) based surveillance definition for NV-HAP, 2) measure the sensitivity, specificity, and positive predictive value of the EHR-based definition versus clinical diagnosis and the existing CDC surveillance definition.3) apply the pilot definition to a large and diverse set of hospitals to characterize the incidence of potential NV-HAP events detected using electronic surveillance data. This will also include:

• an assessment of variability in NV-HAP rates and outcomes across hospitals in order to understand the generalizability of the surveillance method and to determine the variation in disease rate across different types of hospitals.

• Assessment of the clinical relevance as measured by attributable treatment, length-of-stay, and mortality. These outcomes should be assessed using an appropriate matched comparison of patients who develop NV-HAP to similar patients who did not develop NV-HAP, adjust for differences in the NV-HAP and non-NV-HAP patients' demographics, admitting service, comorbidities, and severity of illness, and then compare outcomes across different types of hospitals.

More than one Electronic Health Record system should be used to carry out this scope of work.

STATEMENT OF OBJECTIVES

The activities under the contract shall be conducted with the oversight and approval of the CDC Contracting Officer’s Representative (COR).

Base Period Objectives:

Objective 1: Obtain IRB Approvals

Objective 2: Develop a pilot Electronic Health Record (EHR) based surveillance definition for NV-HAP

Objective 3: Measure the sensitivity, specificity, and positive predictive value of the EHR-based definition versus clinical diagnosis and the existing CDC surveillance definition

Objective 4: Apply the pilot definition to a large and diverse set of hospitals to characterize the incidence of potential NV-HAP events detected using electronic surveillance incidence, this will also include:

• an assessment of variability in NV-HAP rates and outcomes across hospitals in order to understand the generalizability of the surveillance method and to determine the variation in disease rate across different types of hospitals.

ATTACHMENT 1 SAMPLE TASK ORDER DOMAIN 1

• Assessment of the clinical relevance as measured by attributable treatment, length-of-stay, and mortality. These outcomes should be assessed using an appropriate matched comparison of patients who develop NV-HAP to similar patients who did not develop NV-HAP, adjust for differences in the NV-HAP and non-NV-HAP patients' demographics, admitting service, comorbidities, and severity of illness, and then compare outcomes across different types of hospitals.

Option Period 1:

The option period will be a logical follow on of all objectives performed during the base Period including refinement, implementation and maintenance of the registry system.

PROGRAM MANAGEMENT OBJECTIVES:

a) Manage, track, and coordinate the activity of all of its resources, partners and subcontractors needed to fulfill the requirements of this contract and to ensure successful and on-time delivery of all task order services and deliverables.

b) Meet with CDC’s Contracting Officer’s Representative (COR) and Contracting Officer (CO) at contract and program initiation to jointly review program management tasks, roles, responsibilities, and the program management reporting requirements.

c) Maintain regular communications with the COR and Science Officer involved with the project.

d) Develop a Program Management Plan (PMP) outlining their approach to performing program and cross-project coordination tasks required to meet the requirements of this contract. The Program Management Plan should also include a description for how and when common performance measures will be collected and reported to CDC as well as how any performance problem trends and disputes involving the project will be addressed for resolution.

e) The Program Management Plan shall be delivered to CDC no later than ten (10) days after contract award. Updates to the plan shall be delivered to CDC as requested.

Develop a Quality Assurance Surveillance Plan (QASP) outlining their approach to performing program and cross-project coordination tasks required to meet the requirements of this contract

ATTACHMENT 1 SAMPLE TASK ORDER DOMAIN 1

GENERAL TASK ORDER INFORMATION

1. GENERAL TASK ORDER INFORMATION

A. Place of Performance: The work to be performed under this contract will be performed at the Contractor’s facility and associated academic, healthcare or research facilities as required.

B. Type of Contract: The government will award a Firm Fixed Price.

C. Government Furnished Property, Equipment, and Services

Applicable Not Applicable

D. Contractor Travel: The cost associate with completing the work/task, should be part of the task cost (i.e

CLIN 0001, CLIN 0002).

Special Clearances:

A. Confidentiality of Information: Work on this project may require that personnel have access to Privacy

Information. Personnel shall adhere to the Privacy Act, Title 5 of the U.S. Code, Section 552a and applicable agency rules and regulations. The user agency will identify and provide direction and guidance for safeguarding all information subject to the Privacy Act. Reports and case files containing individual personal information are confidential. The CDC is not authorized to release individual case reports, and access to individual case data is strictly controlled. The contractor personnel are required to work with case records as well as databases. It is a requirement that the data remain in a controlled access environment.

B. Section 508 Compliance

By agreeing to the terms of the Safe Healthcare, Epidemiology, and Prevention Research Development (SHEPheRD) Program IDIQ Contract, the offeror must comply with Section 508 standards for all deliverables in this task order. The offeror must complete an HHS/CDC checklist(s) as needed for each deliverable specified.

The applicable Section 508 standards to this task order are 1194.

302 Functional Performance Criteria 502 Inoperability with Assistive Technology 503 Applications 504 Authoring Tools 602 Support Documentation 603 Support Services

ATTACHMENT 1 SAMPLE TASK ORDER DOMAIN 1

INVOICING INSTRUCTIONS

Invoice Submission - CDCAG001 – Invoice Submission (Mar 2006)

(a) The Contractor is required to submit the original invoice/voucher directly to the Financial Management Office using one (1) of three (3) methods (but only one method). Invoices shall not be submitted more frequently than one (1) time per month.

(1) By Email: fmoapinv@cdc.gov (the best and preferred method. See paragraph (b).)

(2) By Facsimile: FAX 404-638-5324

(3) By Mail to: The Centers for Disease Control and Prevention Financial Management Office (FMO) P.O. Box 15580 Atlanta, GA 30333

(b) The contractor shall submit the original invoices/vouchers to the CDC FMO, the COR, and the

Contracting Officer (CO). The preferred method for doing so is to simultaneously email electronic files of the invoice and any backup documents to each of the three (3) parties.

(c) The Contractor is , is not required to submit a copy of each invoice directly to the Contracting Officers

Representative concurrently with submission to the Contracting Officer.

(d) In accordance with 5 CFR part 1315 (Prompt Payment Act), CDC's Financial Management Office (FMO) is the designated billing office for the purpose of determining the payment due date under FAR 32.904(b); the controlling “date of receipt” of an invoice is the date on which the FMO receives a proper invoice from the contractor.

(e) The Contractor shall include (as a minimum) the following information on each invoice:

(1) Contractor’s Name & Address

(2) Contractor’s Tax Identification Number (TIN)

(3) Purchase Order/Contract Number and Task Order Number, as appropriate

(4) Invoice Number

(5) Invoice Date

(6) Contract Line Item Number (CLIN) and Description of Item

(7) Quantity

(8) Unit Price & Extended Amount for each line item

(9) Shipping and Payment Terms

(10) Total Amount of Invoice

(11) Name, title and telephone number of person to be notified in the event of a defective invoice

(12) Payment Address, if different from the information in (e) (1).

(13) DUNS + 4 Number

(End of Clause) mailto:FMOAPINV@CDC.GOV

ATTACHMENT 1 SAMPLE TASK ORDER DOMAIN 1

TASK ORDER CLAUSES

52.246-7 Inspection of Research and Development—Fixed-Price (Aug 1996) 52.246-9 Inspection of Research and Development (Short Form) (Apr 1984) 52.232-2 Payments under Fixed-Price Research and Development Contracts (Apr 1984)

FAR 52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Oct 2020)

(a) Definitions. As used in this clause— Backhaul means intermediate links between the core network, or backbone network, and the small subnetworks at the edge of the network (e.g., connecting cell phones/towers to the core telephone network).

Backhaul can be wireless (e.g., microwave) or wired (e.g., fiber optic, coaxial cable, Ethernet).

Covered foreign country means The People’s Republic of China.

Covered telecommunications equipment or services means–

(1) Telecommunications equipment produced by Huawei Technologies Company or ZTE Corporation (or any subsidiary or affiliate of such entities);

(2) For the purpose of public safety, security of Government facilities, physical security surveillance of critical infrastructure, and other national security purposes, video surveillance and telecommunications equipment produced by Hytera Communications Corporation, Hangzhou Hikvision Digital Technology Company, or Dahua Technology Company (or any subsidiary or affiliate of such entities);

(3) Telecommunications or video surveillance services provided by such entities or using such equipment;

or

(4) Telecommunications or video surveillance equipment or services produced or provided by an entity that the Secretary of Defense, in consultation with the Director of National Intelligence or the Director of the Federal Bureau of Investigation, reasonably believes to be an entity owned or controlled by, or otherwise connected to, the government of a covered foreign country.

Critical technology means–

(1) Defense articles or defense services included on the United States Munitions List set forth in the International Traffic in Arms Regulations under subchapter M of chapter I of title 22, Code of Federal Regulations;

(2) Items included on the Commerce Control List set forth in Supplement No. 1 to part 774 of the Export Administration Regulations under subchapter C of chapter VII of title 15, Code of Federal Regulations, and controlled-

(i) Pursuant to multilateral regimes, including for reasons relating to national security, chemical and biological weapons proliferation, nuclear nonproliferation, or missile technology; or

(ii) For reasons relating to regional stability or surreptitious listening;

(3) Specially designed and prepared nuclear equipment, parts and components, materials, software, and technology covered by part 810 of title 10, Code of Federal Regulations (relating to assistance to foreign atomic energy activities);

(4) Nuclear facilities, equipment, and material covered by part 110 of title 10, Code of Federal Regulations (relating to export and import of nuclear equipment and material);

(5) Select agents and toxins covered by part 331 of title 7, Code of Federal Regulations, part 121 of title 9 of such Code, or part 73 of title 42 of such Code; or

(6) Emerging and foundational technologies controlled pursuant to section 1758 of the Export Control Reform Act of 2018 (50 U.S.C. 4817).

Interconnection arrangements means arrangements governing the physical connection of two or more networks to allow the use of another's network to hand off traffic where it is ultimately delivered (e.g., connection of a customer of telephone provider A to a customer of telephone company B) or sharing data and other information resources.

ATTACHMENT 1 SAMPLE TASK ORDER DOMAIN 1

Reasonable inquiry means an inquiry designed to uncover any information in the entity's possession about the identity of the producer or provider of covered telecommunications equipment or services used by the entity that excludes the need to include an internal or third-party audit.

Roaming means cellular communications services (e.g., voice, video, data) received from a visited network when unable to connect to the facilities of the home network either because signal coverage is too weak or because traffic is too high.

Substantial or essential component means any component necessary for the proper function or performance of a piece of equipment, system, or service.

(b) Prohibition.

(1) Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L.

115-232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. The Contractor is prohibited from providing to the Government any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system, unless an exception at paragraph (c) of this clause applies or the covered telecommunication equipment or services are covered by a waiver described in

FAR 4.2104.

(2) Section 889(a)(1)(B) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115-232) prohibits the head of an executive agency on or after August 13, 2020, from entering into a contract, or extending or renewing a contract, with an entity that uses any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system, unless an exception at paragraph (c) of this clause applies or the covered telecommunication equipment or services are covered by a waiver described in FAR 4.2104. This prohibition applies to the use of covered telecommunications equipment or services, regardless of whether that use is in performance of work under a Federal contract.

(c) Exceptions. This clause does not prohibit contractors from providing—

(1) A service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(2) Telecommunications equipment that cannot route or redirect user data traffic or permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(d) Reporting requirement.

(1) In the event the Contractor identifies covered telecommunications equipment or services used as a substantial or essential component of any system, or as critical technology as part of any system, during contract performance, or the Contractor is notified of such by a subcontractor at any tier or by any other source, the Contractor shall report the information in paragraph (d)(2) of this clause to the Contracting Officer, unless elsewhere in this contract are established procedures for reporting the information; in the case of the Department of Defense, the Contractor shall report to the website at https://dibnet.dod.mil. For indefinite delivery contracts, the Contractor shall report to the Contracting Officer for the indefinite delivery contract and the Contracting Officer(s) for any affected order or, in the case of the Department of Defense, identify both the indefinite delivery contract and any affected orders in the report provided at https://dibnet.dod.mil.

(2) The Contractor shall report the following information pursuant to paragraph (d)(1) of this clause

(i) Within one business day from the date of such identification or notification: the contract number; the order number(s), if applicable; supplier name; supplier unique entity identifier (if known); supplier Commercial and Government Entity (CAGE) code (if known); brand; model number (original equipment manufacturer number, manufacturer part number, or wholesaler number); item description; and any readily available information about mitigation actions undertaken or recommended.

(ii) Within 10 business days of submitting the information in paragraph (d)(2)(i) of this clause: any further available information about mitigation actions undertaken or recommended. In addition, the Contractor shall describe the efforts it undertook to prevent use or submission of covered telecommunications equipment or https://www.acquisition.gov/far/part-4#FAR_4_2104 https://www.acquisition.gov/far/part-4#FAR_4_2104 https://dibnet.dod.mil/ https://dibnet.dod.mil/

ATTACHMENT 1 SAMPLE TASK ORDER DOMAIN 1

services, and any additional efforts that will be incorporated to prevent future use or submission of covered telecommunications equipment or services.

(e) Subcontracts. The Contractor shall insert the substance of this clause, including this paragraph (e) and excluding paragraph (b)(2), in all subcontracts and other contractual instruments, including subcontracts for the acquisition of commercial items.

(End of clause)

FAR 52.217-8 Option to Extend Services (Nov 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 10 days prior to expiration of the contract.

FAR 52.217-9 Option to Extend the Term of the Contract (Mar 2000)

1. The Government may extend the term of this contract by written notice to the Contractor within 10 days of contract expiration; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension.

2. If the Government exercises this option, the extended contract shall be considered to include this option clause.

3. The total duration of this contract, including the exercise of any options under this clause, shall not exceed 36 months.

FAR 52.227-14 Rights in Data-General, Alternate IV (Dec 2007) As prescribed in 27.409(b) (5), substitute the following paragraph (c) (1) for paragraph (c) (1) of the basic clause:

(c) Copyright—(1) Data first produced in the performance of the contract. Except as otherwise specifically provided in this contract, the Offeror may assert copyright in any data first produced in the performance of this contract. When asserting copyright, the Offeror shall affix the applicable copyright notice of 17 U.S.C. 401 or 402, and an acknowledgment of Government sponsorship (including contract number), to the data when such data are delivered to the Government, as well as when the data are published or deposited for registration as a published work in the U.S. Copyright Office. For data other than computer software, the Offeror grants to the Government, and others acting on its behalf, a paid-up, nonexclusive, irrevocable, worldwide license for all such data to reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly, by or on behalf of the Government. For computer software, the Offeror grants to the Government and others acting on its behalf, a paid-up, nonexclusive, irrevocable, worldwide license for all such computer software to reproduce, prepare derivative works, and perform publicly and display publicly (but not to distribute copies to the public), by or on behalf of the Government.

HHSAR 352.224-70, Privacy Act (Dec 2015) This contract requires the Contractor to perform one or more of the following:

(This contract requires the Contractor to perform one or more of the following: (a) design; (b) develop; or (c) operate a Federal agency system of records to accomplish an agency function in accordance with the Privacy Act of 1974 (Act) (5 U.S.C. 552a(m)(1)) and applicable agency regulations. The term system of records means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. Violations of the Act by the Contractor and/or its employees may result in the imposition of criminal penalties (5 U.S.C. 552a (i)).The Contractor shall ensure that each of its employees knows the prescribed rules of conduct in 45 CFR part 5b and that each employee is aware that he/she is subject to criminal penalties for violation of the Act to the same extent as Department of Health and Human Services employees. These provisions also apply to all subcontracts the Contractor awards under this contract which require the design, development or operation of the designated system(s) of records (5 U.S.C. 552a(m)(1)). The contract work statement: (a) Identifies the system(s) of records and the design, development, or operation work the Contractor is to perform; and (b) specifies the disposition to be made of such records upon completion of contract performance.

HSSAR 352.270-4a Notice to Offerors, Protection of Human Subjects (December 18, 2015)

ATTACHMENT 1 SAMPLE TASK ORDER DOMAIN 1

(a) The Department of Health and Human Services (HHS) regulations for the protection of human subjects, 45 CFR part 46, are available on the Office for Human Research Protections (OHRP) website at: http://www.hhs.gov/ohrp/index.html.

These regulations provide a systematic means, based on established ethical principles, to safeguard the rights and welfare of human subjects participating in research activities supported or conducted by HHS.

(b) The regulations define a human subject as a living individual about whom an investigator (whether professional or student) conducting research obtains data or identifiable public information through intervention or interaction with the individual, or identifiable private information. In most cases, the regulations extend to the use of human organs, tissue, and body fluids from individually identifiable human subjects as well as to graphic, written, or recorded information derived from individually identifiable human subjects. 45 CFR part 46 does not directly regulate the use of autopsy materials; instead, applicable state and local laws govern their use.

(c) Activities which involve human subjects in one or more of the categories set forth in 45 CFR 46.101(b) (1)-(6) are exempt from complying with 45 CFR part 46. See http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.

(d) Inappropriate designations of the noninvolvement of human subjects or of exempt categories of research in a project may result in delays in the review of a proposal.

(e) In accordance with 45 CFR part 46, offerors considered for award shall file an acceptable Federal-wide Assurance (FWA) of compliance with OHRP specifying review procedures and assigning responsibilities for the protection of human subjects. The FWA is the only type of assurance that OHRP accepts or approves. The initial and continuing review of a research project by an institutional review board shall ensure that: the risks to subjects are minimized; risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result; selection of subjects is equitable; and informed consent will be obtained and documented by methods that are adequate and appropriate. Depending on the nature of the research, additional requirements may apply; see http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.111 for additional requirements regarding initial and continuing review. HHS regulations for the protection of human subjects (45 CFR part 46), information regarding OHRP registration and assurance requirements/processes, and OHRP contact information is available at the OHRP website (at http://www.hhs.gov/ohrp/assurances/index.html).

(f) Offerors may consult with OHRP only for general advice or guidance concerning either regulatory requirements or ethical issues pertaining to research involving human subjects. ONLY the contracting officer may offer information concerning a solicitation.

(g) The offeror shall document in its proposal the approved FWA from OHRP, related to the designated Institutional Review Board (IRB) reviewing and overseeing the research. If the offeror does not have an approved FWA from OHRP, the offeror must obtain an FWA before the deadline for proposal submission. When possible, the offeror shall also certify the IRB’s review and approval of the research. If the offeror cannot obtain this certification by the time of proposal submission they must include an explanation in their proposal. Never conduct research covered by 45 CFR part 46 prior to receiving certification of the research’s review and approval by the IRB.

(End of provision)

HHSAR 352.270-4b Protection of Human Subjects (December 18, 2015)

(a) The Contractor agrees that the rights and welfare of human subjects involved in research under this contract shall be protected in accordance with 45 CFR part 46 and with the Contractor’s current Federal-wide Assurance (FWA) on file with the Office for Human Research Protections (OHRP), Department of Health and Human Services. The Contractor further agrees to provide certification at least annually that the Institutional Review Board has reviewed and approved the procedures, which involve human subjects in accordance with 45 CFR part 46 and the Assurance of Compliance.

(b) The Contractor shall bear full responsibility for the performance of all work and services involving the use of human subjects under this contract and shall ensure that work is conducted in a proper manner and as safely as is feasible. The parties hereto agree that the Contractor retains the right to control and direct the performance of all work under this contract.

Nothing in this contract shall create an agency or employee relationship between the Government and the Contractor, or any subcontractor, agent or employee of the Contractor, or any other person, organization, institution, or group of any kind whatsoever. The Contractor agrees that it has entered into this contract and will discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional judgment or otherwise, as an independent Contractor without creating liability on the part of the Government for the acts of the Contractor or its employees.

(c) Contractors involving other agencies or institutions in activities considered to be engaged in research involving human subjects must ensure that such other agencies or institutions obtain their own FWA if they are routinely engaged in research involving human subjects or ensure that such agencies or institutions are covered by the Contractors’ FWA via designation as http://www.hhs.gov/ohrp/index.html http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.111 http://www.hhs.gov/ohrp/assurances/index.html

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agents of the institution or via individual investigator agreements (see OHRP website at:

http://www.hhs.gov/ohrp/policy/guidanceonalternativetofwa.pdf).

(d) If at any time during the performance of this contract the Contractor is not in compliance with any of the requirements and or standards stated in paragraphs (a) and (b) 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. The Contracting Officer may communicate the notice of suspension by telephone with confirmation 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, after consultation with OHRP, terminate this contract in whole or in part.

(End of clause)

HHSAR 352.270-12 Needle Exchange (December 18, 2015) The Contractor shall not use any funds obligated under this contract to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug.

(End of Clause)

CDC42.0002 Evaluation of Contractor Performance Utilizing CPARS (Apr 2015) In accordance with FAR 42.15, the Centers for Disease Control and Prevention (CDC) will review and evaluate contract performance. FAR 42.1502 and 42.1503 requires agencies to prepare evaluations of contractor performance and submit them to the Past Performance Information Retrieval System (PPIRS). The CDC utilizes the Department of Defense (DOD) web-based Contractor Performance Assessment Reporting System (CPARS) to prepare and report these contractor performance evaluations. All information contained in these assessments may be used by the Government, within the limitations of FAR 42.15, for future source selections in accordance with FAR 15.304 where past performance is an evaluation factor.

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

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

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

Failure to maintain current CPARS contractor representative information will result in the loss of an opportunity to review and comment on performance evaluations.

CDC H049 Non-Disclosure Agreement for Contractor and Contractor Employees (Jun 2020)

(a) The contractor and contractor employees shall prepare and submit Non-Disclosure Agreements (NDA) to the Contracting Officer prior to access of government information or the commencement of work at CDC.

(b) The NDAs, at Exhibit I and II, are required in service contracts where contractor’s employees will have access to non-public and procurement-sensitive information while performing functions in support of the Government. The NDA also requires contractor’s employees properly identify themselves as employees of a http://www.hhs.gov/ohrp/policy/guidanceonalternativetofwa.pdf http://www.cpars.gov/

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contractor when communicating or interacting with CDC employees, employees of other governmental entities, and members of the public (when communication or interaction relates to the contractor’s work with the CDC).

The Federal Acquisition Regulation (FAR) 37.114 (c), states “All contractor personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public or Congress that they are Government officials, unless, in the judgment of the agency, no harm can come from failing to identify themselves. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed.”

(c) The contractor shall inform contractor employees of the identification requirements by which they must abide and monitor employee compliance with the identification requirements.

(d) During the contract performance period, the contractor is responsible to ensure that all additional or replacement contractors’ employees sign an NDA and it is submitted to the Contracting Officer prior to commencement of their work with the CDC.

(e) Contractor employees in designated positions or functions that have not signed the appropriate NDA shall not have access to any non-public, procurement sensitive information or participate in government meetings where sensitive information may be discussed.

(f) The Contractor shall prepare and maintain a current list of employees working under NDAs and submit to the Contracting Officer upon request during the contract period of performance. The list should at a minimum include: contract number, employee’s name, position, date of hire and NDA requirement.

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EXHIBIT I

Centers for Disease Control and Prevention (CDC)

Contractor Non-Disclosure Agreement

I. Non-Public Information [Name of contractor] understands that in order to fulfill the responsibilities pursuant to [Contract name and number] between the Centers for Disease Control and Prevention and [Name of CDC contractor] dated [date], employees of [contractor] will have access to non-public information, including confidential and privileged information contained in Government-owned information technology systems. For purposes of this agreement, confidential information means Government information that is not or will not be generally available to the public.

Privileged information means information which cannot be disclosed without the prior written consent of the CDC.

In order to properly safeguard non-public information, [contractor] agrees to ensure that prior to being granted access to Government information or the commencement of work for the CDC, whichever is applicable, all employees will sign a Non-Disclosure Agreement (NDA) provided by the CDC prior to beginning work for the CDC. Contractor agrees to submit to the contracting official the original signed copies of NDAs signed by the contractor’s employees in accordance with the instructions provided by the contracting official. Failure to provide signed NDAs in accordance with this agreement and instructions provided by the contracting official could delay or prevent the employee from commencing or continuing work at the CDC until such agreement is signed and returned to the contracting official.

Contractor further agrees that it will not cause or encourage any employee to disclose, publish, divulge, release, or make known in any manner or to any extent, to any individual other than an authorized Government employee any non-public information that the employee may obtain in connection with the performance of the employee’s responsibilities to the

CDC.

II. Procurement-Sensitive Information Contractor further agrees that it will not cause or encourage any employee to disclose, publish, divulge, release, or make known in any manner or to any extent, to any individual, other than an authorized Government employee, any procurement-sensitive information gained while in connection with fulfilling the employee’s responsibilities at the CDC. For purposes of this agreement, procurement-sensitive information includes, but is not limited to, all information in Statements of Work (SOW), Requests for Contract (RFC), and Requests for Proposal (RFP); Responses to RFPs, including questions from potential offerors; non-public information regarding procurements; all documents, conversations, discussions, data, correspondence, electronic mail (e-mail), presentations, or any other written or verbal communications relating to, concerning, or affecting proposed or pending solicitations or awards; procurement data;

contract information plans; strategies; source selection information and documentation; offerors’ identities; technical and cost data; the identity of Government personal involved in the solicitation; the schedule of key technical and procurement events in the award determination process; and any other information that may provide an unfair competitive advantage to a contractor or potential contractor if improperly disclosed to them, or any of their employees.

Contractor understands and agrees that employee access to any procurement-sensitive information may create a conflict of interest which will preclude contractor from becoming a competitor for any acquisition(s) resulting from this information. Therefore, if an employee participates in any discussions relating to procurement-sensitive information, assists in developing any procurement-sensitive information, or otherwise obtains any procurement-sensitive information during the course of performing duties at the CDC, contractor understands and agrees that contractor may be excluded from competing for any acquisition(s) resulting from this information.

III. Identification of Non-Government Employees

Contractor understands that its employees are not agents of the Government. Therefore, unless otherwise directed in writing by the CDC, contractor agrees to assist and monitor employee compliance with the following identification procedures:

A. At the beginning of interactions with CDC employees, employees of other Governmental entities, members of the public, or the media (when such communication or interaction relates to the contractor’s work with the CDC), contractors’ employees will identify themselves as an employee of a contractor.

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B. Contractors’ employees will include the following disclosures in all written communications, including outgoing electronic mail (e-mail) messages, in connection with contractual duties to the CDC:

Employee’s name Name of contractor Center or office affiliation Centers for Disease Control and Prevention

C. At the beginning of telephone conversations or conference calls, contractors’ employees will identify themselves as an employee of a contractor.

D. Contractors should not wear any CDC logo on clothing, except for a CDC issued security badge while carrying out work for CDC or on CDC premises. The only other exception is when a CDC management official has granted permission to use the CDC logo.

E. Contractors’ employees will program CDC voice mail message to identify themselves as an employee of a contractor.

I understand that federal laws including, 18 U.S.C. 641 and 18 U.S.C. 2071, provide criminal penalties for, among other things, unlawfully removing, destroying or converting to personal use, or use of another, any public records. Contractor acknowledges that contractor has read and fully understands this agreement.

Name of Contractor:

Signature of Authorized Representative of Contractor: _________________________________

Date: ________________

Copies retained by: Contracting Official and Contractor

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EXHIBIT II

Centers for Disease Control and Prevention (CDC) Contractors’ Employee Non-Disclosure Agreement

I. Non-Public Information I understand that in order to fulfill my responsibilities as an employee of [Name of CDC contractor], I will have access to non-public information, including confidential and privileged information contained in Government-owned information technology systems. For purposes of this agreement, confidential information means Government information that is not or will not be generally available to the public. Privileged information means information which cannot be disclosed without the prior written consent of the CDC.

I [Name of Employee], agree to use non-public information only in performance of my responsibilities to the CDC. I agree further that I will not disclose, publish, divulge, release, or make known in any manner or to any extent, to any individual other than an authorized Government employee, any non-public information that I may obtain in connection with the performance of my responsibilities to the CDC.

II. Procurement-Sensitive Information I further agree that unless I have prior written permission from the CDC, I will not disclose, publish, divulge, release, or make known in any manner or to any extent, to any individual other than an authorized Government employee, any procurement-sensitive information gained in connection with the performance of my responsibilities to the CDC. I specifically agree not to disclose any non-public, procurement-sensitive information to employees of my company or any other organization unless so authorized in writing by the CDC. For purposes of this agreement, procurement-sensitive information includes, but is not limited to, all information in Performance Work Statement (PWS), Requests for Contract (RFC), and Requests for Proposal (RFP); Responses to RFPs, including questions from potential offerors;

non-public information regarding procurements; all documents, conversations, discussions, data, correspondence, electronic mail (e-mail), presentations, or any other written or verbal communications relating to, concerning, or affecting proposed or pending solicitations or awards; procurement data; contract information plans; strategies; source selection information and documentation; offerors’ identities; technical and cost data; the identity of Government personal involved in the acquisition; the schedule of key technical and procurement events in the award determination process; and any other information that may provide an unfair competitive advantage to a contractor or potential contractor if…