75D301-19-Q-70644_v3.3.doc

REQUEST FOR QUOTATIONS

(THIS IS NOT AN ORDER)

THIS RFQ

PAGE OF PAGES

1. REQUEST NO.

75D301-19-Q-70644

2. DATE ISSUED

08/07/2019

3. REQUISITION/PURCHASE REQUEST NO.

00HCVJDD-2019-35698

4. CERT. FOR NAT. DEF.

UNDER BDSA REG. 2

AND/OR DMS REG. 1

RATING

5a. ISSUED BY

6. DELIVERY BY (Date)

5b. FOR INFORMATION CALL (No collect calls)

c. CITY

10. PLEASE FURNISH QUOTATIONS TO

THE ISSUING OFFICE IN BLOCK 5a ON

OR BEFORE CLOSE OF BUSINESS (Date)

IMPORTANT: This is a request for information, and quotations furnished are not offers. If you are unable to quote, please so indicate on this form and return it. This request does not commit the Government to pay any costs incurred in the preparation of the submission of this quotation or to contract for supplies or services. Supplies are of domestic origin unless otherwise indicated by quoter. Any representations and/or certifications attached to this Request for Quotations must be completed by the quoter.

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

ITEM NO.

(a)

SUPPLIES/SERVICES

(b)

QUANTITY

(c)

UNIT

(d)

UNIT PRICE

(e)

AMOUNT

(f)

The Centers for Disease Control and Prevention (CDC), National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Division of STD Prevention (DSTDP) has a requirement for the assessment of STD testing rate and positivity before and after initiation of pre-exposure prophylaxis (PrEP) stratified by age, sex, and race/ethnicity in US private settings. The anticipated period of performance is an 12-month base period for August 27, 2019 through August 26, 2020.

Please submit questions and quote submissions to Martin F. Nemec at oga2@cdc.gov. Questions shall be submitted by 10 a.m. 08/14/2019. Quotes shall be submitted by 2 p.m. 08/21/2019.

b. 20 CALENDAR DAYS

c. 30 CALENDAR DAYS

d. CALENDAR DAYS

NOTE: Additional provisions and representations

SIGN QUOTATION

15. DATE OF

QUOTATION

a. NAME OF QUOTER

c. COUNTY

AREA CODE

AUTHORIZED FOR LOCAL REPRODUCTION

STANDARD FORM 18 (REV. 6-95)

Previous edition not usable

Prescribed by GSA

FAR (48 CFR) 53.215-1(a)

Section A. Line Items

The contractor shall provide support services in accordance with the Statement of Work.

Firm Fixed-Price, Non-Severable Line Item

Period of Performance: 08/27/2019 – 08/26/2020

1 Each

Section B. Statement of Work

Assessment of STD testing rate and positivity before and after initiation of pre-exposure prophylaxis (PrEP) stratified by age, sex, and race/ethnicity in US private settings

I. Background

The Centers for Disease Control and Prevention (CDC) recommends initial and follow-up STD and HIV testing when initiating or continuing HIV pre-exposure prophylaxis (PrEP). More specifically, the following STD tests are recommended for adults prescribed PrEP:

All adults: screen for syphilis at the initial screening and at semi-annual visits

All sexually active adults: screen for gonorrhea at the initial screening and at semi-annual visits

All sexually active men who have sex with men (MSM): screen for chlamydia at the initial screening and at semi-annual visits.

All patients with pharyngeal or rectal sexual exposure should be screened at those sites using a nucleic acid amplification test (NAAT).

There are limited studies for assessing STD testing rates and positivity among PrEP users other than the clinical trials, especially for PrEP users stratified by sex, age, and race/ethnicity in routine practice in private settings in the United States.

II. Purpose

The purpose of this one-year project is to assess the frequencies of STD and HIV testing and positivity/treatment of STDs among PrEP users aged ≥18 years stratified by sex, age, and race/ethnicity in private settings in the United States, and publish the findings in peer-reviewed journals.

III. Scope of work

The vendor must have access to a comprehensive, longitudinal, real-world database to conduct this study. In order to properly assess STD and HIV testing among PrEP patients stratified by sex, age, and race/ethnicity, the 2015-2018 data will be used to conduct this study and the data must at a minimum include medical services, lab tests and results, and prescription drug claims in private settings that serve more than 200,000 patients in the study period in the United States. Payment information (including patient and insurer payments) must also be included. The majority of patients should have race/ethnicity information. The patients may be covered with any health insurance (or no insurance); insurance types may include private health insurance, Medicare, or Medicaid. The number of PrEP users should be more than 500 in the study period.

The vendor will conduct the study to complete the tasks outlined below. No travel is required for this requirement.

IV. Tasks to be performed

The Contractor shall perform the following tasks:

A. Prior to commencing work on the project, the Contractor shall convene a meeting with relevant contractor staff and CDC staff, including the Contract Officer Representative (COR) and scientific project officer (PO). This meeting may be via teleconference. At this meeting, the project goals, objectives, deliverables, and timeline will be discussed.

B. The Contractor shall establish conference calls every two weeks during the performance period (following the initial meeting in IV. A. above) with relevant contractor staff and CDC staff to discuss relevant and timely issues related to the study. These calls may be cancelled or rescheduled with advance CDC concurrence if there are scheduling conflicts or insufficient pending items to discuss on a particular call.

C. The Contractor shall send quarterly written progress report to CDC and a final report to CDC (the final quarter progress report is not required) at the end of the project. These may be sent via email to both the COR and PO. CDC needs to monitor the study closely to make sure the study is proceeding according to the established timeline and that the deliverables are on time.

D. As part of the project, the Contractor shall review current peer-reviewed literature related to STD/HIV testing among PrEP users using a structured approach with search terms and key words that are approved in advance by the CDC PO.

E. The Contractor shall identify and describe the data for this study in terms of number of patients served per year and the number of years of the available data. This information shall be transmitted to CDC via email and shall include patient demographics of age, sex, and race/ethnicity.

F. The Contractor shall develop a study design and analysis plan that will be used to conduct the study. This task will include the following subtasks.

a. Develop algorithms for identifying PrEP users and the date of initiation of PrEP overall and stratified by demographics (age, sex, race/ethnicity), insurance type (private, Medicare, Medicaid, or other) and physician specialty. Initiation of PrEP may be defined as the first date of tenofovir plus emtricitabine (Truvada) prescription in the study period under the condition that the algorithm is constructed such that it can be ensured that patients with this prescription had no evidence of previous HIV or HBV infection and had no PrEP prescription before the study period and that the total number of days of Truvada prescribed should be >30 days.

b. Develop algorithms for identifying continuous PrEP users. This may be defined if there are not a single gap of >14 days in drug supply provided through the tenofovir plus emtricitabine prescriptions within 45 days after initiation of PrEP.

c. A Kaplan-Meier survival curve shall be constructed to monitor the number of PrEP patients over time following initiation.

d. Develop algorithms for identifying the sub-study-population group: continuous PrEP users who were insured for 271 days around the date of initiation: 90 days before the date of initiation and 180 days after the date of initiation.

e. Develop algorithms of identifying date of syphilis, chlamydia, gonorrhea, HIV, HepB, and creatinine tests based on CPT/HCPCS codes (in administrative data) and LOINC codes (in lab data).

f. Calculate the frequency of chlamydia, gonorrhea, syphilis, HIV, HepB, and creatinine testing within 90 days before the initiation of PrEP, between 135 and 225 days after initiation of PrEP among the sub-study-population group overall and stratified by demographics (including insurance type, and using a methodological approach approved in advance by the CDC PO) and physician specialty. Extragenital testing and claims for multiple chlamydia and gonorrhea tests on the same date of service will be assessed.

g. Identify PrEP users who become HIV infected after the initiation of PrEP.

h. Calculate the positivity of chlamydia, gonorrhea, and syphilis testing among the sub-study-population group who were with STD tests overall and stratified by demographics and physician specialty. Medical claims and prescriptions drug claims will be included in this analysis to determine the proportion of positive tests for which treatment was prescribed and treatment was received. Previous studies showed that injection treatments are more likely documented in the medical claims rather than in the prescription drug claims.

i. Estimate the frequency of chlamydia, gonorrhea, syphilis, HIV, HepB, and creatinine testing within 90 days before the initiation of PrEP and within 90 days after stopping PrEP among the PrEP users who stopped PrEP after the initiation. Also estimate the positivity of chlamydia, gonorrhea, and syphilis for those who were tested for chlamydia, gonorrhea, and syphilis, respectively.

j. Estimate the PrEP-related pharmacy costs: total cost paid by insurance for Truvada, patient’s co-pay for Truvada, pharmacy deducible for Truvada, and total of medical costs related to PrEP medical services during the 271-day period among the sub-study-population group.

k. Identify the software that will be used for compiling data and for statistical analyses.

l. Provide statistical methods or models that will be used; methods and models will be approved in advance by the CDC PO.

G. Upon approval by CDC of the study design and analysis plan, secure all necessary institutional review board (IRB) or other human subject approvals external to CDC. CDC will manage the human subject approvals required by CDC; the vendor will support CDC’s efforts by providing any documentation relevant to study design or population that may be required by CDC in order to approve the project.

H. Share data analysis results

a. Generate sufficient tabulations and statistical tests to comprehensively characterize the data set for CDC staff to enable CDC to assess the data available for analysis

b. Share data results with CDC staff following the data analysis plan that was approved by the CDC PO.

I. The Contractor shall disseminate the findings of the study. This task includes subtasks:

a. Take the lead on drafting at least one manuscript summarizing study results before the end of the performance period of this contract. It is expected that the manuscript will have CDC co-authorship and CDC clearance will be required; the clearance process will be managed by CDC staff. Results to be included in each manuscript shall be approved by the CDC PO in advance of beginning work on the manuscript.

b. The Contractor shall also take the lead on preparing one or more abstracts for presentation at abstract-driven professional conferences with CDC co-authorship.

V. Government Furnished Materials

N/A

VI. Period of performance

The period of performance shall commence upon award of a purchase order which will be no later than August 27, 2019, and shall continue through the 12 months following the award and be completed no later than August 26, 2020.

VII. Deliverables

The vendor shall provide the following deliverables to the Project Officer by the dates reflected below.

All electronic files should be delivered in MS Word format and provided via e-mail.

of Copies

2/31/2020 5/30/2020 To CDC PO and COR

text.

VIII. Project Officer

The Project Officer for this procurement is:

TBD

IX. Minimum Vendor Qualifications

The Contractor shall include an MD or PhD who has experience analyzing medical services data, lab test data, and pharmacy data, and STD/HIV-related issues (experience shall be demonstrated by at least one lead- or senior-authored publication in a peer-reviewed journal on these topics indexed by PubMed). The vendor shall also include a statistician who has experience in study design and sampling methodology (which shall be demonstrated by authorship on at least one publication in a peer-reviewed journal including these analytical elements indexed by PubMed, although the previous analyses need not be in the domain of STD analysis).

The contractor shall have access to all needed datasets 2015-2018: medical service data, prescription drug claims data, and laboratory data that include test results in private settings that serve more than 200,000 patients in the United States. The majority of patients should have race/ethnicity information. The patients may be covered with any health insurance (or no insurance). The number of PrEP users may should be more than 500 in the study period. All of these data must be linked for all records.

The sample or study population selected should be represent a broad range of healthcare practices from different venues (including physician offices, outpatient clinics, emergency departments, and urgent care clinics). The medical service data should include different types of healthcare providers (including primary care physicians, infectious disease specialists, physician assistants, and certified nurse practitioners or registered nurses). The patients analyzed for this study should include both male and female patients and patients aged 18 years and older with race/ethnicity information. Databases from multiple sources may be used to assemble the minimum-sized total population (e.g., insurance databases from multiple states can be combined) as long as all required data elements are present in the combined database used for analysis purposes. Final study design parameters will be subject to CDC approval as detailed in section F above.

X. Special Requirements

A. Baseline Security Requirements

Applicability.

1) The requirements herein apply whether the entire contract or order (hereafter “contract”), or portion thereof, includes either or both of the following:

a. Access (Physical or Logical) to Government Information: A Contractor (and/or any subcontractor) employee will have or will be given the ability to have, routine physical (entry) or logical (electronic) access to government information.

b. Operate a Federal System Containing Information: A Contractor (and/or any subcontractor) employee will operate a federal system and information technology containing data that supports the HHS mission. In addition to the Federal Acquisition Regulation (FAR) Subpart 2.1 definition of “information technology” (IT), the term as used in this section includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources.

2) 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.

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

3) Information Security Categorization. In accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories, Appendix C, and based on information provided by the ISSO, CISO, or other security representative, the risk level for each Security Objective and the Overall Risk Level, which is the highest watermark of the three factors (Confidentiality, Integrity, and Availability) of the information or information system are the following:

Confidentiality: [ X ] Low [ ] Moderate [ ] High

Integrity: [ X ] Low [ ] Moderate [ ] High

Availability: [ X ] Low [ ] Moderate [ ] High

Overall Risk Level: [ ] Low [ ] Moderate [ ] High

Based on information provided by the ISSO, Privacy Office, system/data owner, or other security or privacy representative, it has been determined that this solicitation/contract involves:

[ X ] No PII [ ] Yes PII

Complete this section using the information obtained from the Security and Privacy Checklist in Appendix A, parts A and B.

4) Personally Identifiable Information (PII). Per the Office of Management and Budget (OMB) Circular A-130, “PII is information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual.” Examples of PII include, but are not limited to the following: social security number, date and place of birth, mother‘s maiden name, biometric records, etc.

PII Confidentiality Impact Level has been determined to be: [ X ] Low [ ] Moderate [ ] High

5) 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 32 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, re-using, 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.

6) 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.

7) 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).

8) Internet Protocol Version 6 (IPv6). All procurements using Internet Protocol shall comply with OMB Memorandum M-05-22, Transition Planning for Internet Protocol Version 6 (IPv6). .

9) Government Websites. All new and existing public-facing government websites must be securely configured with Hypertext Transfer Protocol Secure (HTTPS) using the most recent version of Transport Layer Security (TLS). In addition, HTTPS shall enable HTTP Strict Transport Security (HSTS) to instruct compliant browsers to assume HTTPS at all times to reduce the number of insecure redirects and protect against attacks that attempt to downgrade connections to plain HTTP. For internal-facing websites, the HTTPS is not required, but it is highly recommended.

10) Contract Documentation. The Contractor shall use provided templates, policies, forms and other agency documents to comply with contract deliverables as appropriate.

See Appendix D for baseline deliverables.

11) 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.

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 CDC Office of Chief Information Security Officer (OCISO).

12) 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 CDC non-disclosure agreement, as applicable. 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.

See Appendix C for the Contractor Non-Disclosure Agreement.

13) Privacy Threshold Analysis (PTA)/Privacy Impact Assessment (PIA) – The Contractor shall assist the CDC Senior Official for Privacy (SOP) or designee with conducting a PTA for the information system and/or information handled under this contract in accordance with HHS policy and OMB M-03-22, Guidance for Implementing the Privacy Provisions of the E-Government Act of 2002.

a. The Contractor shall assist the CDC SOP or designee in reviewing the PIA at least every three years throughout the system development lifecycle (SDLC)/information lifecycle, or when determined by the CDC SOP that a review is required based on a major change to the system (e.g., new uses of information collected, changes to the way information is shared or disclosed and for what purpose, or when new types of PII are collected that could introduce new or increased privacy risks), whichever comes first.

B. Training

1) Mandatory Training for All Contractor Staff. All Contractor (and/or any subcontractor) employees assigned to work on this contract shall complete the applicable HHS/CDC Contractor Information Security Awareness, Privacy, and Records Management training (provided upon contract award) before performing any work under this contract. Thereafter, the employees shall complete CDC Security Awareness Training (SAT), Privacy, and Records Management training at least annually, during the life of this contract. All provided training shall be compliant with HHS training policies.

2) Role-based Training. All Contractor (and/or any subcontractor) employees with significant security responsibilities (as determined by the program manager) must complete role-based training (RBT) within 60 days of assuming their new responsibilities. Thereafter, they shall complete RBT at least annually in accordance with HHS policy and the HHS Role-Based Training (RBT) of Personnel with Significant Security Responsibilities Memorandum.

All HHS employees and contractors with SSR who have not completed the required training within the mandated timeframes shall have their user accounts disabled until they have met their RBT requirement.

3) Training Records. The Contractor (and/or any subcontractor) shall maintain training records for all its employees working under this contract in accordance with HHS policy. A copy of the training records shall be provided to the CO and/or COR within 30 days after contract award and annually thereafter or upon request.

C. Rules of Behavior

1) The Contractor (and/or any subcontractor) shall ensure that all employees performing on the contract comply with the HHS Information Technology General Rules of Behavior.

2) All Contractor employees performing on the contract must read and adhere to the Rules of Behavior before accessing Department data or other information, systems, and/or networks that store/process government information, initially at the beginning of the contract and at least annually thereafter, which may be done as part of annual CDC Security Awareness Training. If the training is provided by the contractor, the signed ROB must be provided as a separate deliverable to the CO and/or COR per defined timelines above.

D. Incident Response

FISMA defines an incident as “an occurrence that (1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system; or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies. The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines incidents as events involving cybersecurity and privacy threats, such as viruses, malicious user activity, loss of, unauthorized disclosure or destruction of data, and so on.

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 or (2) an authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose.

OMB Memorandum M-17-12, “Preparing for and Responding to a Breach of Personally Identifiable Information” (03 January 2017) states:

Definition of an Incident:

An occurrence that (1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system; or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies.

Definition of a Breach:

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 or (2) an authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose.

It further adds:

A breach is not limited to an occurrence where a person other than an authorized user potentially accesses PII by means of a network intrusion, a targeted attack that exploits website vulnerabilities, or an attack executed through an email message or attachment. A breach may also include the loss or theft of physical documents that include PII and portable electronic storage media that store PII, the inadvertent disclosure of PII on a public website, or an oral disclosure of PII to a person who is not authorized to receive that information. It may also include an authorized user accessing PII 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”.

Contracts with entities that collect, maintain, use, or operate Federal information or information systems on behalf of CDC shall include the following requirements:

1) The contractor shall cooperate with and exchange information with CDC officials, as deemed necessary by the CDC Breach Response Team, to report and manage a suspected or confirmed breach.

2) All contractors and subcontractors shall properly encrypt PII in accordance with OMB Circular A-130 and other applicable policies, including CDC-specific policies, and comply with HHS-specific policies for protecting PII. To this end, all contractors and subcontractors shall 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.

3) All contractors and subcontractors shall participate in regular training on how to identify and report a breach.

4) All contractors and subcontractors shall report a suspected or confirmed breach in any medium as soon as possible and no later than 1 hour of discovery, consistent with applicable CDC IT acquisitions guidance, HHS/CDC and incident management policy, and United States Computer Emergency Readiness Team (US-CERT) notification guidelines. To this end, the Contractor (and/or any subcontractor) shall respond to all alerts/Indicators of Compromise (IOCs) provided by HHS Computer Security Incident Response Center (CSIRC) or CDC Computer Incident Response Team (CSIRT) within 24 hours via email at csirt@cdc.gov or telephone at 866-655-2245, whether the response is positive or negative.

5) All contractors and subcontractors shall be able to determine what Federal information was or could have been accessed and by whom, construct a timeline of user activity, determine methods and techniques used to access Federal information, and identify the initial attack vector.

6) All contractors and subcontractors shall allow for an inspection, investigation, forensic analysis, and any other action necessary to ensure compliance with HHS/CDC Policy and the HHS/CDC Breach Response Plan and to assist with responding to a breach.

7) Cloud service providers shall use guidance provided in the FedRAMP Incident Communications Procedures when deciding when to report directly to US-CERT first or notify CDC first.

8) Identify roles and responsibilities, in accordance with HHS/CDC Breach Response Policy and the HHS/CDC Breach Response Plan. To this end, the Contractor shall NOT notify affected individuals unless and until so instructed by the Contracting Officer or designated representative. If so instructed by the Contracting Officer or representative, all notifications must be pre-approved by the appropriate CDC officials, consistent with HHS/CDC Breach Response Plan, and the Contractor shall then send CDC- approved notifications to affected individuals; and,

9) Acknowledge that CDC will not interpret report of a breach, by itself, as conclusive evidence that the contractor or its subcontractor failed to provide adequate safeguards for PII.

E. Position Sensitivity Designations

All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR).

The requiring activity representative, in conjunction with Personnel Security, shall use the OPM Position Sensitivity Designation automated tool (https://www.opm.gov/investigations/) to determine the sensitivity designation for background investigations. After making those determinations, include all applicable position sensitivity designations.

F. Homeland Security Presidential Directive (HSPD)-12

The Contractor (and/or any subcontractor) and its employees shall comply with Homeland Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and Contractors; OMB M-05-24; FIPS 201, Personal Identity Verification (PIV) of Federal Employees and Contractors; HHS HSPD-12 policy; and Executive Order 13467, Part 1 §1.2.

For additional information, see HSPD-12 policy at: https://www.dhs.gov/homeland-security-presidential-directive-12)

Roster. The Contractor (and/or any subcontractor) shall submit a roster by name, position, e-mail address, phone number and responsibility of all staff working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain a government information system(s). The roster shall be submitted to the COR and/or CO by the effective date of this contract. Any revisions to the roster as a result of staffing changes shall be submitted immediately upon change. The COR will notify the Contractor of the appropriate level of investigation required for each staff member.

G. Contract Initiation and Expiration

1) General Security Requirements. The Contractor (and/or any subcontractor) shall comply with information security and privacy requirements, Enterprise Performance Life Cycle (EPLC) processes, HHS Enterprise Architecture requirements to ensure information is appropriately protected from initiation to expiration of the contract. All information systems development or enhancement tasks supported by the contractor shall follow the HHS EPLC framework and methodology and in accordance with the HHS Contract Closeout Guide (2012).

HHS EA requirements may be located here: https://www.hhs.gov/ocio/ea/documents/proplans.html

CDC EPC Requirements: https://www2a.CDC.gov/CDCup/library/other/eplc.htm

2) System Documentation. Contractors (and/or any subcontractors) must follow and adhere to NIST SP 800-64, Security Considerations in the System Development Life Cycle, at a minimum, for system development and provide system documentation at designated intervals (specifically, at the expiration of the contract) within the EPLC that require artifact review and approval.

3) 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 all required documentation 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.

4) Notification. The Contractor (and/or any subcontractor) shall notify the CO and/or COR and system ISSO before an employee stops working under this contract.

5) 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.

6) The Contractor (and/or any subcontractor) shall perform and document the actions identified in the CDC Out-Processing Checklist (http://intranet.cdc.gov/od/hcrmo/pdfs/hr/Out_Processing_Checklist.pdf) when an employee terminates work under this contract. All documentation shall be made available to the CO and/or COR upon request.

H. Records Management and Retention

The Contractor (and/or any subcontractor) shall maintain all information in accordance with Executive Order 13556 -- Controlled Unclassified Information, National Archives and Records Administration (NARA) records retention policies and schedules and HHS policies and shall not dispose of any records unless authorized by HHS.

In the event that a contractor (and/or any subcontractor) accidentally disposes of or destroys a record without proper authorization, it shall be documented and reported as an incident in accordance with HHS policies.

I. List of Deliverables

(y/n)

J. Privacy Act

It has been determined that this contract is not subject to the Privacy Act of 1974, because this contract provides for the design, development, or operation of a system of records on individuals.

The System of Records Notice (SORN) that is applicable to this contract is: N/A

The disposition to be made of the Privacy Act records upon completion of contract performance is: TBD

Section C. Clauses

SIMPLIFIED ACQUISITION TERMS AND CONDITIONS

52.232-39

52.232-40

352.222-70

Unenforceability of Unauthorized Obligations (Jun 2013)

Providing Accelerated Payments to Small Business Contractors (Dec 2013)

Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015)

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

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

http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/far1toc.htm http://www.hhs.gov/policies/hhsar/subpart301-1.html (End of Clause)

52.212-5 -- Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items (May 2019)

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

(4) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(5) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77, 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.] _X_ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), 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 (Oct 2015) (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 (Oct 2018) (Pub. L. 109-282) (31 U.S.C. 6101 note).

___ (5) [Reserved]

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

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

___ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Oct 2015) (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 (Nov 2011) (15 U.S.C. 657a).

___ (ii) Alternate I (Nov 2011) of 52.219-3.

___ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C. 657a).

___ (ii) Alternate I (Jan 2011) of 52.219-4.

___ (13) [Reserved]

___ (14) (i) 52.219-6, Notice of Total Small Business Aside (Nov 2011) (15 U.S.C. 644).

___ (ii) Alternate I (Nov 2011).

___ (iii) Alternate II (Nov 2011).

___ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).

___ (ii) Alternate I (Oct 1995) of 52.219-7.

___ (iii) Alternate II (Mar 2004) 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 (Aug 2018) (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 (Nov 2016) of 52.219-9.

___ (v) Alternate IV (Aug 2018) of 52.219-9.

___ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).

___ (19) 52.219-14, Limitations on Subcontracting (Jan 2017) (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)).

___ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657f).

_X_ (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)).

___ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Dec 2015) (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 (Dec 2015) (15 U.S.C. 637(m)).

_X_ (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

_ X_ (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2018) (E.O. 13126).

_ X_ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

_ X_ (28) (i) 52.222-26, Equal Opportunity (Sep 2016) (E.O. 11246).

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

___ (29) (i) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

___ (ii) Alternate I (July 2014) of 52.222-35.

_X_ (30) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

___ (ii) Alternate I (July 2014) of 52.222-36.

___ (31) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212).

___…