Attachments 1-8.pdf

ATTACHMENT 1 – GLOSSARY OF TERMS & REFERENCES

Term Definition Ad-hoc Services Additional analytical and programming support, to enable FDA personnel to obtain prescriptions, patients, claims and any other utilization metrics not available through the online data tools.

Aggregated Data Any data that has been re-formatted or derived from the original data report or data set, e.g., raw data. Aggregated data are typically presented in tables, charts, and text.

Characterizing Describing the hospitalization episode with regard to diagnoses, procedures, dates of admission and discharge, length of stay and discharge disposition; age and gender of the patient; all required characteristics of ALL drug therapy, including generic and established drug names, strength, dosage form. Other desired characteristics of the hospitalization episode can be included as available.

Commercially Available

The data resource, or access to it, is available for sale or has been sold to the general public as of June 1, 2005. (Note: The FDA does not intend to use this solicitation to initiate or complete development of a resource.)

Currently Existing The data chosen for this award must be a commercially available product at the time of the proposal. The FDA does not intend to use this solicitation to initiate or complete development of a resource.

Data Dictionary A document that describes the information available in the data resource. This information shall minimally include field or variable name, description, definition (including business rules for computed fields and missing data), and allowed values and percentage of discharges or patients. All fields or variables in the data resource should be included in this document.

De-identified Data Data that has had key patient information removed, e.g., name, address, social security number, and date of birth, so that any user or audience shall not purposefully or inadvertently discover a patient’s identity. However, the capability of tracking a single individual (e.g. patient A) across multiple encounters over time and of differentiating that individual from another individual (e.g. patient B) shall be required.

Demographic The age and gender of the patient shall be required. Information on race/ethnicity shall be included if available, accompanied by documentation of the origin of this data.

Desktop Authorized FDA personnel should be able to access the data from their own computers (i.e., no special or customized hardware should be required for access).

Direct Authorized FDA personnel should be able to access raw or sample numbers from the data source from their desktop (i.e., no intervention on the contractors part should be necessary. In addition, output that consists of formatted reports only will not be acceptable).

Disclosure Policy The process of providing FDA written authorization to disclose information from this resource in public forums or sharing with third parties on collaborative projects initiated by FDA for public health safety and regulatory purposes. This process shall ensure that the information or data disclosed is accurate and does not violate any of the Offeror’s existing agreements.

Episode A single admission to a short-stay hospital or emergency department.

Firewall-to-Firewall Virtual Private Network (VPN)

Secure TCP/IP connection between two firewalls that simulates a local area network.

Encryption/decryption and authentication are mandatory for the VPN solution.

Food and Drug Administration Amendments Act

FDAAA 2007

The Food and Drug Administration Amendments Act (FDAAA) of 2007 (H.R. 3580) was signed into law on September 27, 2007 and represented a significant addition to FDA authority. Section 905 of FDAAA directed FDA to develop methods to obtain access to disparate data sources and to establish a post-market risk identification and analysis system. The law set a goal of access to data from 25 million patients by July 1, 2010, and

100 million patients by July 1, 2012. The law also required FDA to work closely with partners from public, academic, and private entities. In response, FDA launched the Drug Utilization Initiative to achieve these mandates.

https://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmen tstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/ucm184271.htm

Federal Information Security Management Act

(FISMA)

The Federal Information Security Management Act of 2002 (FISMA) was passed in 2002 as Title III of the E-Government Act (Public Law No. 107-347). FISMA requires each federal agency to develop, document, and implement agency-wide programs to provide information security for the operations and assets of the agency, including those provided or managed by other agencies or outside contractors.

Full Disclosure Of data collection, construction, coding and configuration – The FDA shall receive detailed information on how the sample is selected, how data are obtained and cleaned/edited for analysis, how the data was built how variables are defined, and the relationship between variables within the data structure.

Geographic Diversity

The patients whose information is represented in the data shall not be concentrated in any single geographic area, but rather shall be broadly distributed throughout the United States.

Health Insurance Portability and Accountability Act

(HIPAA)

The Health Insurance Portability and Accountability Act (HIPAA) of 1996 (Public Law No.

104-191) is a federal law that governs: 1) health insurance coverage for workers and their families when they change or lose their jobs; and 2) the establishment of national standards for electronic healthcare data transactions.

https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdf

HIPPAA Compliance Process to ensure compliance with the regulations establishing national standards for health care information, according to the Health Insurance Portability and Accountability Act (HIPAA) of 1996.

HIPAA Privacy Rule The HIPAA Privacy Rule (45 CFR Part 160 and Subparts A and E of Part 164) establishes national standards to protect individuals' medical records and other individual health information and applies to health plans, healthcare clearinghouses, and those healthcare providers that conduct certain healthcare transactions electronically.

The Rule requires appropriate safeguards to protect the privacy of individual health information and sets limits and conditions on the uses and disclosures that may be made of such information without patient authorization.

https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdf

Immediate Authorized FDA personnel shall be able to access the data whenever needed.

Multi-user Environment

Two or more authorized FDA users should be able to access the data at the same time from different locations.

National-Level The ability to accurately estimate drug utilization for the U.S. population using the sample captured in the data resource.

Projection or Other Appropriate Methodologies

Projection methodology is an algorithm that can be used to reliably and accurately estimate drug utilization for the U.S. population using the sample captured in the data.

Other appropriate methodologies may include, gathering drug utilization data on the universe of adult and pediatric and emergency department (e.g., a “census” method), which may reduce or eliminate the need for projection. Should a “census” method be chosen, the Contractor shall provide mutually acceptable evidence.

Raw Data Data in the form obtained from the data access tool which is not further summarized or processed.

https://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf https://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/ucm184271.htm https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/ucm184271.htm https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/ucm184271.htm https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/ucm184271.htm https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdf https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdf https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdf https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdf

Real-time Real-time access refers to doing something while people are watching or waiting. FDA expects The Contractor to provide information on how readily available access to their data will be.

Reliable The projection method used must yield the same or similar results in the same or similar situations (e.g., must be reproducible and repeatable).

Robust In cases where the assumptions underlying the projection or other appropriate methodology are not all met, the results obtained should be the same as in similar situations where all assumptions and conditions are fully met.

Secure At no time will passwords, login, or data be open to inspection or intrusion by unauthorized parties.

Secure Internet Access

Browser based, encrypted point-to-point access using hypertext transmission protocol, secure (HTTPS) or Secure Socket Layer (SSL).

Short-Stay Hospitals

Average length of the hospital admission is 60 days or less

Unlimited Authorized FDA personnel shall have the ability to use any data element in the database in any combination or query that is necessary to address a specific issue.

Valid An assessment of how well the projected values reflect what is actually happening in the entire population of interest.

ATTACHMENT 2 – DATA CHARACTERISTICS TABLE

The contractor shall provide a technical narrative for each data source core requirement in their proposal.

Hospital Drug Utilization Data and Treatment Procedures in short-stay and/or free-standing pediatric hospitals (All items are required unless stated as “if available” please provide description or state as Y/N with explanation or description)

Overall Population and Data Characteristics:

• Month and year of when data collection began

• The total number of years of data available

• The amount of data available online on a standard basis

• The ability and method of accessing data that is no longer online

• The lag time between date of service and online availability of all types of data available

• Description of their data source, type of data, and full disclosure of collection and projection methodology demonstrating that the resource can provide national estimates of adult and pediatric hospital drug utilization data and treatment procedures in short-stay

• Description of Contractor’s business that specifically details the percentage of data committed for hospital drug utilization data and treatment procedures in short-stay. In addition, the Contractor shall provide the largest percentage of any single data provider.

• Description of data de-identification method

• Description on the size and characteristics of the hospitals from which the data are derived, e.g., number of hospitals, size of hospitals, geographic diversity of hospitals (using census regions), type of hospitals, , and a description of specialty units within sample hospitals.

• The number of unique patients hospitalized per year in the sample and their demographic distribution (to include numbers and percentages) compared to an appropriate national benchmark (e.g. AHA, NHDS) in addition to numbers and percentages of discharges per year of special populations of interest to the FDA, including neonates, children (ages ≤ 17 years), elderly (ages ≥ 65 years), pregnancies and deliveries, and patients with serious illnesses including HIV/AIDS and mental illness.

• Comparison of hospital drug utilization data and treatment procedures in short-stay hospitals to the most recent American Hospital Association (AHA) Annual Survey and the National Hospital Discharge Survey (NHDS) by age (10-year increments), gender, and the four census regions (Northeast, Midwest, South, West).

• Availability of hospital drug utilization data and treatment procedures in short-stay hospitals at the discharge-level and/or patient-level.

• Availability of age and gender of the patient at the hospital visit.

• Availability of hospitalization and/or ED episode data

• Availability of data related to all drugs administered during the hospital episode

• Availability of data related to diagnoses and treatment procedures shall be required for all procedures performed during the hospital episode, and shall include the procedures coded in ICD and CPT/HCPCS codes

• Overall number of hospitals, , health care practitioners, visits, and patients represented in the entire database.

• A description of the drug coding system used, including the number of drug coding levels available

• A description of clinical or medical coding system used, including number of levels of clinical or medical coding

• Raw/sample numbers, as well as projected numbers, if available; and the frequency with which data are updated and methods for updates

• Interface documentation (white paper, training manual, etc)

• Method and frequency for updating interface

• The frequency distribution of patient-level characteristics associated with patient encounters (to include numbers and percents).

• Method of simultaneous, multi-user access and number and nature of limits to access, including numbers of users, numbers and types of data elements

• Past history of scheduled and unscheduled downtime of data

• Capability and methods for end-user downloading data, including maximum number of records (number of rows and file size) and formats available

• Complete data dictionary (including percentage of missing or incomplete data)

The availability of data to describe and quantify the hospital episode in short-stay hospitals (Specify the following and provide percentage missing for each item):

• Admission Date [Y/N]

• Discharge Date [Y/N]

• ED visit Date [Y/N]

• Date and time of drug administration [Y/N]

• Diagnosis/conditions present on admission [Y/N]

• Drugs at Admission [Y/N]

• Drugs at Discharge [Y/N

• Length of Stay [Y/N]

• Length of Therapy [Y/N]

• All diagnoses related to the hospital visit [Y/N]

• Primary discharge diagnosis [Y/N]

• Secondary discharge diagnosis [Y/N]

• All procedures related to hospitalization or ED visit [Y/N]

• Date and time of procedures related to the hospital visit [Y/N]

• Laboratory test performed [Y/N]

• Microbiology data (e.g., cultures, sensitivities, antigen testing, etc.) [Y/N]

• Discharge Disposition [Y/N]

The availability of data to describe and quantify the administration of drug in the hospital setting for short-stay hospitals (Specify the following and provide percentage missing for each item):

• Generic Name of Drug [Y/N]

• Established Name of Drug [Y/N]

• Strength of active ingredients [Y/N]

• Dosage Form of active ingredients [Y/N]

• Route of administration [Y/N]

• Service Location (e.g. NICU, ICU) [Y/N]

• Treatment dose and duration [Y/N]

• Radiology Drugs and Contrast Agents [Y/N]

• Operating Room Drugs [Y/N]

• Anesthetic Drugs [Y/N]

• Market, Drug class, Product Brand, Branded generic, generic, and molecule level data [Y/N]

• Manufacturer, Company and Corporation for product level data [Y/N]

• Concomitant Drug class, Product Brand, Branded generic, generic, and molecule level data [Y/N]

Availability of patient demographics and basic data (Specify the following and provide percentage missing for each item):

Age [Y/N] – Please specify method by which age is obtained and how it is displayed in reports, i.e., standard age groups, customized age groups, single years, age in months)

Patient Gender [Y/N]

Patient Race/ethnicity [Y/N]

Patient Height [Y/N]

Patient Weight [Y/N]

Patient GFR [Y/N] (Glomecular Filtration Rage)

Patient Body Mass Index [Y/N]

Patient Pregnancy status [Y/N]

Patient Geographic region [Y/N]

Patient Clinical measures, i.e., blood pressure, lipid parameters, renal function [Y/N]

Patient Smoking status [Y/N]

Patient Discharge status [Y/N]

Availability of diagnoses and treatment procedures performed (procedure-specific and diagnosis-specific data elements) in the hospital setting for short-stay and/or free-standing pediatric hospitals: (Specify the following and provide percentage missing for each item):

Primary and Secondary ICD diagnosis code [Y/N]

Primary and Secondary CPT/HCPCS procedure code [Y/N]

Operating Room Procedures [Y/N]

Radiology Procedures [Y/N]

ATTACHMENT 3 – CENSUS REGIONS

Northeast Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont

Midwest Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Nebraska, North Dakota, Ohio, South Dakota, Wisconsin

South Alabama, Arkansas, Delaware, District of Columbia, Florida, Georgia, Kentucky, Louisiana, Maryland, Mississippi, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, Virginia, West Virginia

West Alaska, Arizona, California, Colorado, Hawaii, Idaho, Montana, Nevada, New Mexico, Oregon, Utah, Washington, Wyoming

ATTACHMENT 4 – DATA DISCLOSURE CLEARANCE PROCEDURES

PURPOSE:

As provided for at FAR 52.227-14 (Alt II), [Name of Contractor] (“Contractor”) has provided a Limited Rights Notice to FDA (Appendix D) identifying Limited Rights Data (see definition below). This Limited Rights Notice authorizes FDA to disclose these Limited Rights Data for public health, safety, and regulatory purposes, provided that the disclosures of these data are made subject to prohibition against their further disclosure.

In accordance with the Limited Rights Notice, the purpose of this document is to establish timely clearance procedures for the FDA and Contractor to follow when FDA seeks either (1) to make Aggregated Limited Rights Data (see definition below) publicly available, or (2) to disclose actual Limited Rights Data to specific third parties subject to prohibition against their further disclosure.

DEFINITIONS:

Aggregated Limited Rights Data -- Any collective or summary presentation of Limited Rights Data that does not disclose any raw data accessed by FDA from [Name of Contractor] (Contractor) [Database System].

De-identified Data – Data that have had patient, hospital, and physician information removed, e.g., names, addresses, social security numbers, and dates of birth, so that any user or audience cannot purposefully or inadvertently discover a patient’s identity.

Limited Rights Data – For purposes of these data disclosure clearance procedures, the definition of Limited Rights Data provided at FAR 52.227-14 is understood to include raw data, accessed by FDA personnel through the [Database Systems].

Public Release – Any communications, meetings, or interactions where FDA personnel make information publicly available, including by disclosing it: to any private, public, or governmental entity other than in accordance with paragraph 5 of these procedures; at any public event, such as the public portion of an advisory committee meeting or a public presentation or demonstration; through any publication in any media, such as scientific and technical articles; or in any agency record that FDA makes available on a non-confidential basis to anyone outside FDA, including in accordance with the Freedom of Information Act.

PROCEDURES:

These clearance procedures do not apply to disclosure of information, including of Limited Rights Data and/or Aggregated Limited Rights Data, made in response to an authorized request of Congress or any other government body of competent jurisdiction (see [section of primary agreement in which such disclosures are discussed] [Database System] (“Agreement”).

1. FDA and Contractor shall complete the Clearance Procedure Cover Sheet (Appendix F) is a blank copy) upon execution of the Agreement. This form provides the names and contact information for individuals who shall serve as the primary contact (Contact) for each party. Each party must update the Cover Sheet any time any of its contact information or its Contact changes.

2. For each proposed disclosure, FDA shall submit a Clearance Request Form (Appendix F) is a blank copy), a copy of the materials to be disclosed, and a copy of the source data files cited in those materials.

3. FDA shall identify Contractor as the data source when disclosing Aggregated Limited Rights Data or Limited Rights Data.

4. Within 48 hours of receipt by the Contractor's Contact of the Clearance Request Form, Contractor shall provide a clearance decision for the requested Public Release of Aggregated Limited Rights Data. For urgent clearances requests, the Contractor shall provide a clearance decision within 24 hours of receipt.

5. Disclosure approval applies to the life of the materials as approved. FDA shall notify the contractor of further release, at the contractor’s request.

6. Within 72 hours of receipt by the Contractor's Contact of the Clearance/Third Party Request Form, the Contractor shall provide a decision for disclosure of Limited Rights Data to a third party in accordance with the following conditions:

a. The third party must be actively engaged in a project initiated by FDA;

b. Clearance to share the data with the third party shall be granted only for purposes of the

FDA initiated project and shall not extend beyond the duration of the third party's active engagement in that project;

c. The third party must execute in a timely manner the required Contractor Third Party Access agreement and agree in writing to return any copies of the data provided to, or made by, that party when the third party is no longer actively engaged in such project or at such earlier time as FDA may request in writing; and

d. The third party must agree in writing not to release the Limited Rights Data to any additional party.

7. If a third party that received Limited Rights Data in accordance with paragraph 5 seeks to disclose materials that include Aggregated Limited Rights Data, the third party must submit an electronic copy of those materials and of the source data files relied upon to FDA for submission to Contractor for clearance approval. Clearance to use Limited Rights Data and/or Aggregated Limited Rights Data does not grant any third party rights to use the (Name of Contractor) (Contractor) [Database Systems] software tools. TERM: This policy shall be in effect for the calendar year for the length of the contract and thereafter until either party notifies the other of its termination or Contractor provides to the FDA a different policy.

ATTACHMENT 5 – DATA DISCLOSURE CLEARANCE FORMS

I. COVER SHEET

Date: __________

Contractor's Address: Client’s Address:

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002

Contact Name: Contact Name:

Telephone: Telephone:

E-mail: E-mail:

FDA CLEARANCE/THIRD PARTY REQUEST FORM

INSTRUCTIONS:

- Review Data Disclosure Clearance Procedures before completing this form.

- For all requests, complete "Clearance Type/Requestor Information" and "Project" sections.

- For requests to publicly disclose Aggregated Limited Rights Data, complete "Section I."

- For requests to share Limited Rights Data with specific third parties, complete "Section II."

CLEARANCE TYPE/REQUESTOR INFORMATION:

Clearance requested for (check one): Date of this Clearance Request:

Public Release of Aggregated Limited Rights Data by FDA (complete project description and Section I)

Request form completed by:

Disclosure of Limited Rights Data to a third party (complete project description and Section II)

Phone number of requestor:

E-mail address of requestor:

PROJECT DESCRIPTION:

Name(s) and description(s) of FDA project associated with the use of the data:

FDA contact(s) for the project(s):

SECTION I: (Public Release of Aggregated Limited Rights Data by FDA)

Purpose of Aggregated Limited Rights Data use:

Publication Research

Presentation Other, please specify:

Audience and name of publication(s), presentation(s), or forum(s):

Date(s) of publication(s), presentation(s), or forum(s) (if known):

The following items must be provided electronically by FDA with this Clearance Form (if practicable):

Drug file name:

Query file name (if applicable):

Contractor shall provide clearance by e-mail for the release(s) identified in this Section I.

SECTION II: (Disclosure of Limited Rights Data to a third party)

Description of third party:

Company or Agency Name:

Address:

Contact for project:

Describe third party association with FDA (e.g., contractor, research partner, etc.):

How will the limited rights data be used?

Has the third party read and agreed to all the conditions set forth in the clearance? Yes No

The requesting parties hereby agree to the terms and conditions set forth in the clearance procedure and submit this request to [Contractor].

FDA THIRD PARTY

Signature:

Name (print):

Title:

Date:

Signature:

Name (print):

Title:

Date:

[Contractor], hereby grants data disclosure clearance for the purpose(s) identified in this Section II.

CONTRACTOR

Signature:

Name (print):

Title:

Date:

Note on obtaining copies of proprietary software from contractors

If FDA may wish to receive from a data provider copies of associated proprietary software that was not developed with FDA funds:*

(1) In addition to cross-referencing FAR 52.227-14, the data access agreement should--

a. cross-reference FAR 52.227-14 Alt. III (1987) regarding access to "restricted computer software"; and

b. include the following statement, explaining that such software constitutes "restricted computer software" for purposes of the agreement:

Restricted Computer Software -- For purposes of [Agreement], the definition of Restricted Computer Software provided at FAR 52.227-14 is understood to include any proprietary computer software the development of which FDA did not fund.

(2) The Contractor should provide a Restricted Rights Notice to FDA with the software as provided for at FAR 52.227-14 Alt. III (1987). The content of the notice can be specified in the agreement.

Contact legal counsel if the parties wish to use language in the notice that is different from the model language provided at FAR 52.227-14 Alt. III (1987).

*If FDA paid for development of the software, the software would not be "restricted computer software" and these special provisions and procedures would not apply.

ATTACHMENT 6 – TRIAL SUBSCRIPTION AGREEMENT

TRIAL SUBSCRIPTION AGREEMENT

BETWEEN [ * ]

AND THE

FOOD AND DRUG ADMINISTRATION

This Trial Subscription Agreement ("Agreement") sets forth an agreement between [ * ] and the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) for the purposes stated and under the terms and conditions as set forth herein.

Background: [ * ] has developed an internet-accessible or network-based inpatient drug utilization database software program [ ** ]. As part of that effort, [ * ] is willing to extend to FDA a 30-day trial subscription of [ ** ] at no cost to FDA. At the conclusion of the trial subscription period, FDA may, at its discretion, choose to purchase a full subscription to [ ** ] or allow the subscription to lapse.

Ownership and Reservation of Rights: [ * ] reserves all rights not expressly granted herein. Except as set forth in this Agreement, no express or implied license or right of any kind is granted to FDA, including, but not limited to, any right to know, use, produce, receive, reproduce, copy, market, sell, distribute, transfer, translate, modify, adapt, disassemble, decompile or reverse engineer [ * ] or the documentation or any portions thereof. FDA acknowledges and agrees that [ * ] owns all rights, title, and interest, including all copies and documentation thereof, regardless of the form in which the copies may exist, and that [ ** ] is not in the public domain.

Warranties: FDA agrees that [ ** ] is provided to FDA "as is.” All express or implied conditions, representations, and warranties, including any implied warranty or merchantability satisfactory quality or fitness for a particular purpose, are disclaimed.

Proprietary Information:

a. FDA acknowledges that [ ** ] is a commercially valuable, proprietary product of [ * ] and that it contains confidential information, inventions, processes, trade secrets and intellectual properties.

b. FDA agrees to hold data collected from [ ** ] in confidence and not to, directly or indirectly, copy, reproduce, distribute, transmit, duplicate, reveal, report, publish, disclose, cause to be disclosed, or transfer such data to any third party, or utilize such data for any purpose whatsoever other than as expressly contemplated by this Agreement. FDA shall require all of its employees, agents, independent contractors, and all others who have any access to [ ** ] to abide by the confidentiality and proprietary provisions of this Agreement. All obligations under this paragraph will expire upon termination of the trial subscription unless FDA purchases a full subscription thereafter.

c. The foregoing obligations shall not apply if and to the extent that:

(i) FDA establishes that data which appears in [ ** ] were already known to FDA, without obligations to keep such information confidential, at initiation of the trial subscription period;

(ii) FDA establishes that data which appear in [ ** ] were received by FDA in good faith from a third party lawfully in possession thereof and having no obligation to keep such information confidential;

(iii) FDA establishes that data which appear in [ ** ] were publicly known at initiation of the trial subscription period or have become publicly known other than by a breach of this Agreement; or

(iv) FDA is ordered by an administrative agency or other governmental body of competent jurisdiction to disclose certain data that appear in [ ** ].

Limitation of Liability: To the fullest extent permitted by Federal law, in no event shall [ * ] be liable to the FDA for any loss, claim, damage, or liability, of whatsoever kind or nature that may arise from or in connection with this Agreement.

Term and Termination: This Agreement shall become effective upon its execution by both parties. The term of this Agreement shall be thirty (30) days and shall continue in full force and effect until termination at the sole discretion of either party. At the conclusion of the trial subscription period, FDA shall immediately return to [ * ] any proprietary [ ** ] data or other confidential information, and all copies thereof, together with all documentation related to the [ ** ], unless FDA purchases a full subscription thereafter. In the event that a party hereto violates or is in default of any material provision of this Agreement or the FDA is legally required to disclose information to a third party, this Agreement will terminate immediately without notice. Either party may terminate the Agreement upon written notice to the other party.

IN WITNESS WHEREOF, the parties hereto have executed this Agreement by their duly authorized representative as of the effective date below.

Agreed to and accepted by: Agreed to and accepted by:

[ * ] Food and Drug Administration

Signature: ______________________ Signature: _______________________

Name: _________________________ Name: __________________________

Title: _________________________ Title: __________________________

Date: _________________________ Date: __________________________

* Name of Offeror

** Name of Database System

FDA User 1/2010 2/2010 3/2010 4/2010 5/2010 6/2010 7/2010 8/2010 User name User name User name 7 User name User name User name User name User name User name 1 User name User name User name User name User name 22 1 User name User name User name User name User name User name User name User name User name User name 1 User name User name 55 14 User name User name User name 8 User name 5 7 User name User name User name User name 9 20 User name User name User name User name 1 8 User name User name

ATTACHMENT 7 – EXAMPLE OF MONTHLY USAGE REPORT

Department of Health and Human Service (HHS)

Federal Acquisition Regulation (FAR) Class Deviation 18‐01

Whistleblower Protection for Contractor Employees

Solicitation and Contract Addendum for Commercial Items/Services that Exceed the Simplified Acquisition Threshold

Background: The FAR currently provides that when the 4‐year pilot program under 41 U.S.C. 4712 expires, the previous whistleblower coverage is back in effect. However, the Civilian Agency Acquisition

Council (CAAC) issued CAAC Letter 2017‐02, dated July 5, 2017, to further implement 41 U.S.C. 4712 (as amended by Public Law 114‐261) to make permanent the 4‐year pilot program and clarifies the use of certain Whistleblower Protection clauses. In turn, the HHS Deputy Assistant Secretary for Office of

Grants and Acquisition Policy and Accountability/Senior Procurement Executive issued HHS FAR Class

Deviation 18‐01, dated February 8, 2018, to implement CAAC guidance and Enhance Whistleblower

Protection for Contractor Employees.

Pursuant to the above‐stated authorities, the underlying solicitation/contract hereby incorporates the following Terms and Conditions:

PART 3‐IMPROPER BUSINESS PRACTICES AND PERSONAL CONFLICTS OF INTEREST

Subpart 3.9‐whistleblower Protections for Contractor Employees

3.900 Scope of subpart.

This subpart implements various statutory whistleblower programs. This subpart does not implement 10 U.S.C. 2409, which is applicable only to DoD, NASA, and the Coast Guard.

41 U.S.C. 4705 (in effect before July 1, 2013). Sections 3.901 through 3 .906 of this subpart implemented 41 U.S.C. 4705, applicable to civilian agencies other than NASA and the Coast Guard.

41 U.S.C. 4712 (in effect on and after July 1, 2013). Section 3.908 of this subpart implements the pilot program, applicable to civilian agencies other than NASA and the Coast Guard, except as provided in paragraph {d) of this section.

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), implemented in 3.909, applicable to all agencies.

Contracts funded by the American Recovery and Reinvestment Act. Section 3.907 of this subpart implements section 1553 of the American Recovery and Reinvestment Act of 2009 (Pub. L. 111‐ 5), and applies to all contracts funded in whole or in part by that Act.

[This space intentionally left blank.]

ATTACHMENT 8

52.203‐17 Contractor Employee Whistleblower Rights and Requirement to Inform Employees of

Whistleblower Rights. (APR 2014)

(a) This contract and employees working on this contract will be subject to the whistleblower rights and remedies in the pilot program on Contractor employee whistleblower protections established at 41

U.S.C. 4712 by section 828 of the National Defense Authorization Act for Fiscal Year 2013 (Pub. L. 112‐

239) and FAR 3.908

(b) The Contractor shall inform its employees in writing, in the predominant language of the workforce, of employee whistleblower rights and protections under 41 U.S.C. 4712, as described in section 3.908 of the Federal Acquisition Regulation.

(c) The Contractor shall insert the substance of this clause, including this paragraph (c), in all subcontracts over the simplified acquisition threshold.

(End of clause)

PART 52‐SOLICITATION PROVISIONS AND CONTRACT CLAUSES

52.212‐4 Contract Terms and Conditions‐Commercial Items (Deviation 2017‐02).

As prescribed in 12.301(b)(3), the following clause applies:

CONTRACT TERMS AND CONDITIONS‐COMMERCIAL ITEMS (DEVIATION 2017‐XX) (JUNE 2017)

(a)***

Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C.

1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18

U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety

Standards; 41 U.S.C. chapter 87, Kickbacks; 10 U.S.C 2409 relating to whistleblower protections; 49

U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

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

Commercial Items (Deviation 2017‐02).

As prescribed in 12.301(b)(4), the following clause applies:

CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS‐

COMMERCIAL ITEMS (DEVIATION 2017‐XX) (JUNE 2017)

[This space intentionally left blank.]

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:

_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).

_X_ (2) 52.203‐13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.SC. 3509).

Note: Applies only if the value of the contract is expected to exceed $5.5 million and the performance period is anticipated to be 120 days or more.

_X_ (3) 52.203‐15, Whistleblower Protections under the American Recovery and Reinvestment Act of

2009 (June 2010) (Section 1553 of Pub. L. 111‐5).

Note: Applies only to contracts funded by the American Recovery and Reinvestment Act of

2009. Please contact the FDA Contracting Officer if you have any questions regarding the application of the clause.

_X_ (4) 52.203‐17, Contractor Employee Whistleblower Rights and Requirement to Inform Employees of

Whistleblower Rights (April 2014) (41 U.S.C. 4712) relating to whistleblower protections).

The paragraphs below are renumbered

52.301 Solicitation provisions and contract clauses (Matrix).

Please see CAAC Letter 17‐02, available at:

https://www.acquisition.gov/sites/default/files/page_file_uploads/CAAC%20Letter%202017‐02.pdf.