NEW - Medication Data Surveillance Project

The objective of this work is to provide the most recent data available from the Integrated Dataverse (IDV®) to allow the continued surveillance of CVD prescription medication fills. Data will be shared with the American Medical Association (AMA) after a data use agreement between AMA and Source Healthcare Analytics is approved and signed by both parties.

SCOPE of Work

The contractor shall provide the following data from the Integrated Dataverse® (IDV) for 2019. The contractor shall provide stratified national, 50 state and District of Columbia, and 10 Core Based Statistical Area (CBSA’s) antihypertensive, statin and cardiovascular prescription fill trend data for the full year of 2019 as outlined in the parameters below.

Parameters:

Data Source

The services will be provided from the Integrated Dataverse® (IDV) repository.

Time Period

January 2019 through December 2019.

Channel

Retail projected

Mail order projected

Mail order unprojected

Patient Gender

Male

Female

Patient Age Groups

Age groups segmented as follows:

<8

8-11

12-17

18-34

35-44

45-54

55-64

65-74

75+

Unknown

Prescriber Specialty

Results segmented by prescriber specialty (including by SPECIALTY_DESC and SPECIALTY_CODE)

Brand/Generic Segmentation

Branded

Generic

Prescription Type

New

Refill

Total

Payment Type

Commercial

Medicare

Managed Medicaid

Assistance

Cash

Medicaid

National, State & CBSA Data:

#

USC5_CODE

USC5_NAME

1

11131

CYCLOOXYGENASE INHIBITORS, ALONE/COMB

2

11132

DENOSINE RECEPTOR ANT AG, ALONE/COMB

3

11133

GLYCOPROTEIN INHIBITORS, ALONE/COMB

4

11134

PAR-1 ANTAGONISTS, ALONE/COMBINATIONS

5

11139

PLATELET INHIBITORS, OTHER

6

31110

ANGIOTENSIN CONVERTING ENZYME INHIBITORS

7

31111

ACE INHIBITORS, ALONE

8

31112

ACE INHIBITORS WITH DIURETICS

9

31118

ACE INHIBITORS OTHER

10

31120

ANGIOTENSIN II ANTAGONIST

11

31121

ANGIOTENSIN II ANTAGONIST, ALONE

12

31122

ANGIOTENSIN II ANTAGONIST, WITH DIURETIC

13

31123

ANGIOTENSIN II ANTAGONIST, WITH CCB

14

31124

ANGIOTENSIN II ANTAG,WITH CCB & DIURETIC

15

31129

ANGIOTENSIN II ANTAGONIST, WITH OTHER

16

31130

SELECTIVE ALDOSTERONE RECEPTOR INHIBITOR

17

31141

DIRECT RENIN INHIBITORS, ALONE

18

31142

DIRECT RENIN INHIBITORS WITH DIURETIC

19

31149

DIRECT RENIN INHIBITORS,OTHER

20

31200

PERIPHERAL V ASODILATORS

21

31300

CALCIUM CHANNEL BLOCKERS

22

31410

BETA BLOCKERS

23

31420

ALPHA-BETA BLOCKERS

24

31430

BETA/ALPHA-BETA BLOCKER WITH DIURETICS

25

31440

ALPHA BLOCKERS ALONE OR COMBINATIONS

26

31450

CENTRALLY ACTING AGENTS, ALONE OR COMBOS

27

31800

VASCULAR/ ANTIHYPERLIPIDEMIC COMBINATION

28

31900

ANTIHYPERTENSIVE, OTHER

29

32110

HMG-COA REDUCT ASE INHIBITORS

30

32112

CHOLESTEROL REDUCERS, OTHERS

31

32120

BILE ACID SEQUESTRANTS

32

32130

FIBRIC ACID DERIVATIVES

33

32140

CHOLESTEROL ABSORPTION INHIBITORS

34

32150

PCSK9 INHIBITORS

35

32180

CHOLESTEROL REDUCER COMBINATIONS

36

32190

CHOLESTEROL REDUCERS, OTHER

37

32200

LIPOTROPICS

38

32900

ANTIHYPERLIPIDEMIC AGENTS􀀎 OTHER

39

39269

DPP-4 INHIBITOR COMBINATION, OTHER

40

41100

DIURETICS

41

41110

DIURETICS, THIAZIDE AND RELATED

42

41120

DIURETICS, LOOP

43

41130

DIURETICS, POTASSIUM SPARING

44

41140

DIURETICS, COMBINATIONS

45

41190

DIURETICS, OTHER

46

69000

SMOKING DETERRENTS

47

69200

SMOKING DETERRENTS,OTC

 

Market Definition

Reported at the Blue Book USC Level for National, State and CBSA Data. Reported at the select molecule level for Ambiguous and Sentinel Data.

Sentinel Medication List

Molecule

AMLODIPINE

ATENOLOL

CHLORTHALIDONE

HYDROCHLOROTHIAZIDE

LISINOPRIL

LOSARTAN

SIMVASTATIN

SPIRONOLACTONE

Geography

National, State and CBSA Level for 10 select CBSA's

#

CBSA Description

1

Atlanta-Sandy Springs-Marietta, GA

2

Baltimore-Towson, MD

3

Chicago-Joliet-Naperville, IL-IN-WI

4

Dallas-Fort Worth- Arlington, TX

5

Denver-Aurora-Broomfield, CO

6

Memphis, TN-MS-AR

7

Minneapolis-St. Paul-Bloomington, MN-WI

8

New York-Northern New Jersey-Long Island, NV-NJ

9

Philadelphia-Camden-Wilmington, PA-NJ-DE-MD

10

San Diego-Carlsbad-San Marcos, CA

SECTION 4 – TASKS TO BE PERFORMED

 

Data is provided for CY 2019 below:

1. Drug Dimension/ Crosswalk file (drug and molecule levels)

Field Name

NDC

USC2_CODE

USC2_NAME

USC3_CODE

USC3_NAME

USC4_CODE

USC4_NAME

USC5_CODE

USC5_NAME

PRODUCT

MOLECULE

STRENGTH

FORM

INGREDIENT_NBR

INGREDIENT

PACKAGE

BRAND_GENERIC

RX_STATUS

PRODUCT_DATE

PRODUCT_END_ DATE

ACTIVITY_IND

CORPORATION

MANUFACTURER

ATC1 ID

ATC1 NAME

ATC2 ID

ATC2 NAME

ATC3 ID

ATC3 NAME

ATC4 ID

ATC4 NAME

2.         State level fill rates by medication class and sub-class that can be aggregated at the US national level.

3.         Select CBSA geography medication fill rates by medication class and sub-class

Layout for Items (2-3) above:

COLUMN NAME

NOTE

STATE/CBSA _CODE

State or CBSA Code or National

CBSA_DESC

ONLY in CBSA Table

USC_CODE

BLUE BOOK USC CODE

USC_NAME

BLUE BOOK USC NAME

CHANNEL

Retail/Mail Order Proj/Mail Order UnProj

SPECIALTY_CODE

Specialty Code, w/ NP: or PA: prefix for Nurse Practitioners or Physicians Assistance

SPECIALTY_DESC

Specialty Description

PATIENT_GENDER

Female/Male

PATIENT_AGE

<8/8-11/12-17/18-34/35-44/45-54/55-64/65- 74/75+/UNK

BRAND_GENERIC

Generic/Brand

PAY_TYPE

COMMERCIAL/MEDICARE

PAYMENT/MANAGED MEDICAID PAYMENT/ASSISTANCE

PROGRAMS/CASH PAYMENT/MEDICAID PAYMENT

YEAR

2019

QUARTER

1/2/3/4

VALID_RX_PRICE

1/0, 1 ifTOTAL_RX_PRICE consists of both PLAN_PAY and PATIENT_PA Y being not null, for improved calculation of averages

NEW_FILLS

New Claim Count

REFILLS

Refill Claim Count

TOTAL_FILLS

Total Claim Count

TOTAL_PTNT_PAY

Total Price paid by PATIENT

TOTAL_FILLS_PTNT_PAY_UNK

Claim Count where PTNT PAY is NULL

TOTAL_FILLS_PTNT_PAY_ZERO

Claim Count where PTNT PAY = 0

TOTAL_FILLS_PTNT_PAY_LOW

Claim Count where PTNT _PAY greater than 0 and less than or equal to 5

TOTAL_RX_AMOUNT

Total Pill Quantity

TOTAL_RX_PRICE

Total Price paid by Final Plan+ Patient Pay

TOTAL_FILLS_PLAN_AND_PTNT_UNK

Claim Count where PLAN PAY AND PTNT PAY is NULL

TOTAL_FILLS_PLAN_OR_PTNT_UNK

Claim Count where PLAN PAY OR PTNT PAY is NULL

TOTAL_FILLS_PLAN_UNK

Claim Count where PLAN PAY is NULL

TOTAL_FILLS_PTNT_UNK

Claim Count where PTNT PAY is NULL

THERAPY_DAYS

Total Days' Supply

Perc_Max_Dose

Percentage of maximum dosage (the mean percentage of the maximum dosage for each medication filled within the USC5 classification (e.g., 10 mg fill within a medication type having a maximum dosage of 50 mg would equate to 20% of max dosage)

4. Sentinel medication fill rates

COLUMN NAME

NOTE

GENERIC_NAME

List of eight sentinel medications

STRENGTH

Categorical variable with multiple groupings. Categories depend on the medication and will be determined after the final crosswalk file is provided. Total number of fills in each dosage category.

FORM

Drug Form

COMBINATION

Fixed dose pill (combination) or single medication (plain)

STATE

State Code

USC_CODE

BLUE BOOK USC CODE

USC_NAME

BLUE BOOK USC NAME

CHANNEL

Retail/Mail Order Proi/Mail Order UnProi

SPECIALTY_CODE

Specialty Code, w/ NP: or PA: prefix for Nurse Practitioners or Physicians Assistance

SPECIALTY_DESC

Specialty Description

PATIENT_GENDER

Female/Male

PATIENT_AGE

<8/8-11/12-17/18-34/35-44/45-54/55-64/65- 74/75+/UNK

BRAND_GENERIC

Generic/Brand

PAY_TYPE

COMMERCIAL/MEDICARE

PAYMENT/MANAGED MEDICAID PAYMENT/ASSISTANCE PROGRAMS/CASH PAYMENT/MEDICAID PAYMENT

YEAR

2019

QUARTER

1/2/3/4

VALID_RX_PRICE

1/0, 1 ifTOTAL_RX_PRICE consists of both PLAN_ PAY and PATIENT_ PAY being not null, for improved calculation of averages

NEW_FILLS

New Claim Count

REFILLS

Refill Claim Count

TOTAL_FILLS

Total Claim Count

TOTAL_PTNT_PAY

Total Price paid by PATIENT

TOTAL_FILLS_PTNT_PAY_UNK

Claim Count where PTNT PAY is NULL

TOTAL_FILLS_PTNT_PAY_ZERO

Claim Count where PTNT PAY = 0

TOT AL_FILLS_PTNT_PAY_LOW

Claim Count where PTNT_PAY greater than O and less than or equal to 5

TOTAL_RX_AMOUNT

Total Pill Quantity

TOTAL_RX_PRICE

Total Price paid by Final Plan+ Patient Pay

TOTAL_FILLS_PLAN_AND_TNT_UNK

Claim Count where PLAN PAY AND PTNT -PAY is Null

TOTAL_FILLS_PLAN_OR_PTNT_UNK

Claim Count where PLAN PAY OR PTNT -PAY is Null

TOTAL_FILLS_PLAN_UNK

Claim Count where PLAN PAY is NULL

TOTAL_FILLS_PTNT_UNK

Claim Count where PTNT PAY is NULL

THERAPY_DAYS

Total Days' Supply

SECTION 5 – GOVERNMENT FURNISHED MATERIALS

 

Not Applicable.

 

 

SECTION 6 – PERIOD OF PERFORMANCE

 

Contract Period of Performance is as follows: September 1, 2020 – January 31, 2021. The Services will be a one-time deliverable delivered to the Client contact (COR) via SFTP.

 

SECTION7 – DELIVERABLES/REPORTING SCHEDULE

Task No.

Milestone/ Deliverable

Deliverable

Deliverable Due Date

Deliver to

1

Drug Dimension I Crosswalk file (drug and molecule levels)

SAS Dataset/Excel Spreadsheet

October 1, 2020

COR

2

State level fill rates by medication class and sub-class that can be aggregated at the national level.

SAS Dataset/Excel Spreadsheet

October 1, 2020

COR

3

Select CBSA geography medication fill rates by medication class and sub-class

SAS Dataset/Excel Spreadsheet

October 1, 2020

COR

4

Sentinel medication fill rates

SAS Dataset/Excel Spreadsheet

November 1, 2020

SECTION 8 – REFERENCE MATERIALS

 Not Applicable.

SECTION 9 – POINT OF CONTACT INFORMATION

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

SECTION 10 – PAYMENT TERMS

 Contract will be a firm, fixed price contract.

 Task

Milestone/ Deliverable

Deliverable Due Date

DHDSP Initial Review

DHDSP Secondary Review (if needed)

1

Drug Dimension I Crosswalk file (drug and molecule levels)

October 1, 2020

November 1, 2020*

December 14, 2021**

2

State level fill rates by medication class and sub-class that can be aggregated at the national level.

October 1, 2020

November 1, 2020*8

December 14, 2021**

3

Select CBSA geography medication fill rates by medication class and sub-class

October 1, 2020

November 1, 2020*8

December 14, 2021**

4

Sentinel medication fill rates

November 1, 2021

December 1, 2021*

January 14, 2021**

 

Quality Standards:

DHDSP will have thirty days to review all the deliverables and provide feedback to the contractor. If the contractor does not receive any feedback within thirty days of delivery, then the deliverable is deemed approved by DHDSP.* If DHDSP identifies and communicates to the contractor potential issues with the material provided within these thirty days, the contractor shall provide a response to those concerns within fourteen days. DHDSP will have an additional thirty days from the date the contractor response was communicated to provide any additional feedback.**

 

SECTION 11 – MINIMUM VENDOR QUALIFICATIONS AND LEVEL OF EFFORT

The contractor shall provide the aggregate, de-identified data described above. The USC crosswalk, class and sub-class level AHM data, and ambiguous class data files will be provided in CSV files that will be sent via secure electronic delivery system. The detailed national, state, and MSA data files stratified by medication class and the other specified variables will be provided in SAS table files via a web portal or similar secure process.

Information Security Requirements

1. Baseline Security Requirements

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

1. 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.
2. Operate a Federal System Containing Information:  A Contractor (and/or any subcontractor) 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. 

1. 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:

1. 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.

1. 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. 
2. 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.
3. Comply with the Privacy Act requirements and tailor FAR clauses as needed..

1. Information Security Categorization.  In accordance with FIPS 199 andNational 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:                           [X] 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

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

1. Controlled Unclassified Information (CUI). CUI is defined as “information that laws, regulations, or Government-wide policies require to have safeguarding or dissemination controls, excluding classified information.” The Contractor (and/or any subcontractor) must comply with Executive Order 13556, Controlled Unclassified Information, (implemented at 3 CFR, part 2002) when handling CUI. 32 C.F.R. 2002.4(aa) As implemented the term “handling” refers to “…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, 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:

   1. marked appropriately;
   2. disclosed to authorized personnel on a Need-To-Know basis;
   3. protected in accordance withNIST SP 800-53, Security and Privacy Controls for Federal Information Systems and Organizations applicable baselineif handled by a Contractor system operated on behalf of the agency,orNIST SP 800-171, Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations if handled by internal Contractor system; and
   4. 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.
2. 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.
3. 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/CDCsanction policies and/or governed by the following laws and regulations:

1. 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records);
2. 18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information); and
3. 44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act).

1. 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).
2. 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.
3. Contract Documentation. The Contractor shall use provided templates, policies, forms and other agency documents to comply with contract deliverables as appropriate.
4. Standard for Encryption. The Contractor (and/or any subcontractor) shall: 

1. Comply with the HHS Standard for Encryption of Computing Devices and Information to prevent unauthorized access to government information.
2. 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.
3. 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).
4. 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 and ISSO within 30 days of contract award.
5. Use the Key Management system on the HHS personal identification verification (PIV) card or establish and use a key recovery mechanism to ensure the ability for authorized personnel to encrypt/decrypt information and recover encryption keys.  Encryption keys shall be provided to the COR upon request and at the conclusion of the contract.

1. 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. 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.
2. 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 to determine whether or not a full PIA needs to be completed.

1. If the results of the PTA show that a full PIA is needed, the Contractor shall assist the CDC SOP or designee with completing a PIA for the system or information within 30 days after completion of the PTA and in accordance with HHS policy and OMB M-03-22, Guidance for Implementing the Privacy Provisions of the E-Government Act of 2002.
2. 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 agency that a review is required based on a major change to the system, or when new types of PII are collected that introduces new or increased privacy risks, whichever comes first.
    

1. 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 specific Information Security Awareness, 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 annually commensurate with their role and responsibilities in accordance with HHS policy and the HHS Role-Based Training (RBT) of Personnel with Significant Security Responsibilities Memorandum.
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.

1. 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, and any CDC-specific rules, as applicable.
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 Information 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.

1. Incident Response

The Contractor (and/or any subcontractor) shall respond to all alerts/Indicators of Compromise (IOCs) provided by HHS Computer Security Incident Response Center (CSIRC)/CDCCSIRT teams within 24 hours, whether the response is positive or negative.

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.  The HHS Policy for IT Security and Privacy Incident Reporting and Response  further defines a breach as “a suspected or confirmed incident involving PII” . 

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

1. Protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract so as to avoid a secondary sensitive information incident with FIPS 140-2 validated encryption.
2. NOT notify affected individuals unless so instructed by the Contracting Officer or designated representative. If so instructed by the Contracting Officer or representative, the Contractor shall send CDC approved notifications to affected individuals following CDC’s designated process.
3. Report all suspected and confirmed information security and privacy incidents and breaches to the CDC’s Computer Security Incident Response Team (CSIRT) [CSIRT@CDC.gov], COR, CO, CDC SOP (or his or her designee), and other stakeholders, including incidents involving PII, in any medium or form, including paper, oral, or electronic, as soon as possible and without unreasonable delay, no later than one (1) hour, and consistent with the applicable CDC and HHS policy and procedures, NIST standards and guidelines, as well as US-CERT notification guidelines. The types of information required in an incident report must include at a minimum: company and point of contact information, contract information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor shall:

1. cooperate and exchange any information, as determined by the Agency, necessary to effectively manage or mitigate a suspected or confirmed breach;
2. not include any sensitive information in the subject or body of any reporting e-mail; and
3. encrypt sensitive information in attachments to email, media, etc.

1. Comply with OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information HHS and CDC’s incident response policies when handling PII breaches.
2. Provide full access and cooperate on all activities as determined by the Government to ensure an effective incident response, including providing all requested images, log files, and event information to facilitate rapid resolution of sensitive information incidents. This may involve disconnecting the system processing, storing, or transmitting the sensitive information from the Internet or other networks or applying additional security controls. This may also involve physical access to contractor facilities during a breach/incident investigation.
    
    

1. 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 following position sensitivity designation levels apply to this solicitation/contract: Level 1

1. 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 within the CDC Specified timeline of the effective date of this contract. Any revisions to the roster as a result of staffing changes shall be submitted within 7 days of the change.  The COR will notify the Contractor of the appropriate level of investigation required for each staff member. 

If the employee is filling a new position, the Contractor shall provide a position description and the Government will determine the appropriate suitability level.

1. 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 CDC EPLC framework and methodology and in accordance with the HHS Contract Closeout Guide (2012).  CDC EPLC requirements may be located here: 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 within 7 days 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 CDCpolicies.
6. The Contractor (and/or any subcontractor) shall perform and document the actions identified in the CDCContractor Employee Separation Checklist when an employee terminates work under this contract within 7days of the employee’s exit from the contract.  All documentation shall be made available to the CO and/or COR upon request.

1. 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/CDC policies and shall not dispose of any records unless authorized by HHS/CDC.

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/CDC policies.

HHSAR Provision, 352.239-73: Electronic and Information Technology Accessibility Notice

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

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

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

                205 WCAG 2.0 Level A & AA Success Criteria

                302 Functional Performance Criteria

                502 Inoperability with Assistive Technology

                504 Authoring Tools

                602 Support Documentation

                603 Support Services 

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

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

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

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

(End of provision)