Attachments_Access_2017.doc

Appendix A

Glossary

Aggregated data – High-level summary data on groups that is composed of a collection of other more individual data.

Applications Programmer-Devises or modifies procedures to solve complex problems considering computer equipment capacity and limitations, operating time, and form of desired results. Designs, codes, tests, debugs, and documents

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 January, 2009 (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), allowed values, and percentage of discharges or patients in the data resource where it is present. All fields or variables in the data resource shall 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 shall be able to access the data from their own computers (i.e., no special or customized hardware shall be required for access).

Direct – Authorized FDA personnel shall be able to access raw or sample numbers from the data source from their desktop (i.e., no intervention on the contractors part shall 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 Contractor’s existing agreements.

Emergency Department (ED - ) Hospital facility for the provision of unscheduled outpatient services to patients whose conditions require immediate care and staffed 24 hours a day.

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

Firewall-to-firewall virtual private network (VPN) – A Secure TCP/IP connection made between two firewalls that simulate a local area network. Encryption/decryption and authentication are mandatory for the VPN solution.

Free-standing pediatric hospital – hospitals with inpatient and emergency department services for pediatric patients predominantly age 18 years or younger. Their Medicare provider numbers begin with 3300.

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

HIPAA 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.

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

Inpatient setting – Any place where health care is received while admitted to the hospital as an inpatient (NB: Day surgery, ambulatory care centers, and other outpatient services provided by hospitals are not considered to be inpatient settings).

Multi-user environment – Two or more authorized FDA users shall 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. inpatient population using the sample captured in the data resource.

Pharmacist-Dispense drugs prescribed by physicians and other health practitioners and provide information to patients about medications their use. May advise physicians and other health practitioners on the selection, dosage, interactions, and side effects of medications.

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, but are not limited to, 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.

Project Manager-Leads team on large projects or significant segment of large complex projects. Analyzes new and complex project related problems and creates innovative solutions involving finance, scheduling, technology, methodology, tools, and solution components Raw data- Data in the form obtained from the data access tool which is not further summarized or processed.

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 shall 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).

Senior Computer Analyst-Analyze science, engineering, business, and other data processing problems to implement and improve computer systems. Analyze user requirements, procedures, and problems to automate or improve existing systems and review computer capabilities, workflow, and scheduling limitations. May analyze or recommend commercially available software

Senior Training Specialist-Assesses, designs, and conceptualizes training scenarios, approaches, objectives, plans, tools, aids, curriculums, and other state of the art technologies related to training and behavioral studies. Identifies the best approach training requirements to include, but not limited to hardware, software, simulations, course assessment and refreshment, assessment centers, oral examinations, interviews, computer assisted and adaptive testing, behavior-based assessments and performance, and team and unit assessment and measurement. Develops and revises training courses. Prepares training catalogs and course materials. Trains personnel by conducting formal classroom courses, workshops, and seminars.

Short-stay hospitals – average length of the hospital admission is 60 days or less

Statistician-At least 10 years of experience and training in economics, finance, statistics, or related areas. Demonstrated record of supporting development and delivery of presentations, publications, and reports on specific programs or technically complex subjects. An Economist/Statistician is responsible for performing work of a technically complex nature in the areas of economics and statistics, including cost-benefit and regulatory impact analysis, financial analysis, risk assessment, statistical analysis, sampling, survey design and implementation; and for reviewing the work of other staff

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.

APPENDIX B

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

APPENDIX C

Section 508 Standards

Section 508 of the Rehabilitation Act Amendments of 1998 (29 U.S.C. § 794 (d) was enacted in the Workforce Investment Act of 1998. Section 508 requires 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. The Act required the Architectural and Transportation Barriers Compliance Board (Access Board) to create federal standards for electronic and information technology (EIT) products (goods and services) to make them more accessible by individuals with disabilities.

Each Offeror will be evaluated on their conformance to the Section 508 Standards identified below as being applicable for this requirement. The conformance to these standards will be evaluated as follows:

1. Conformance at proposal submission

2. Conformance by scheduled delivery date, after insignificant or no contractor development

3. Conformance by scheduled delivery date, after significant contractor development

No allowance is given here for partial performance as gradations are difficult to verify and add complexity.

Using the following web site, Offerors can access resources for understanding and implementing the requirements of Section 508 http://www.section508.gov (See Appendices C & D)

The following applications standards have been identified as being applicable for this service:

§ 1194.21 Software applications and operating systems.

(a) When software is designed to run on a system that has a keyboard, product functions shall be executable from a keyboard where the function itself or the result of performing a function can be discerned textually.

(b) Applications shall not disrupt or disable activated features of other products that are identified as accessibility features, where those features are developed and documented according to industry standards. Applications also shall not disrupt or disable activated features of any operating system that are identified as accessibility features where the application programming interface for those accessibility features has been documented by the manufacturer of the operating system and is available to the product developer.

(c) A well-defined on-screen indication of the current focus shall be provided that moves among interactive interface elements as the input focus changes. The focus shall be programmatically exposed so that assistive technology can track focus and focus changes.

(d) Sufficient information about a user interface element including the identity, operation and state of the element shall be available to assistive technology. When an image represents a program element, the information conveyed by the image must also be available in text.

(e) When bitmap images are used to identify controls, status indicators, or other programmatic elements, the meaning assigned to those images shall be consistent throughout an application's performance.

(f) Textual information shall be provided through operating system functions for displaying text. The minimum information that shall be made available is text content, text input caret location, and text attributes.

(g) Applications shall not override user selected contrast and color selections and other individual display attributes.

(h) When animation is displayed, the information shall be displayable in at least one non-animated presentation mode at the option of the user.

(i) Color coding shall not be used as the only means of conveying information, indicating an action, prompting a response, or distinguishing a visual element.

(j) When a product permits a user to adjust color and contrast settings, a variety of color selections capable of producing a range of contrast levels shall be provided.

(k) Software shall not use flashing or blinking text, objects, or other elements having a flash or blink frequency greater than 2 Hz and lower than 55 Hz.

(l) When electronic forms are used, the form shall allow people using assistive technology to access the information, field elements, and functionality required for completion and submission of the form, including all directions and cues.

§ 1194.22 Web-based intranet and internet information and applications.

a) A text equivalent for every non-text element shall be provided (e.g., via "alt", "longdesc", or in element content).

(b) Equivalent alternatives for any multimedia presentation shall be synchronized with the presentation.

(c) Web pages shall be designed so that all information conveyed with color is also available without color, for example from context or markup.

(d) Documents shall be organized so they are readable without requiring an associated style sheet.

(e) Redundant text links shall be provided for each active region of a server-side image map.

(f) Client-side image maps shall be provided instead of server-side image maps except where the regions cannot be defined with an available geometric shape.

(g) Row and column headers shall be identified for data tables.

(h) Markup shall be used to associate data cells and header cells for data tables that have two or more logical levels of row or column headers.

(i) Frames shall be titled with text that facilitates frame identification and navigation.

(j) Pages shall be designed to avoid causing the screen to flicker with a frequency greater than 2 Hz and lower than 55 Hz.

(k) A text-only page, with equivalent information or functionality, shall be provided to make a web site comply with the provisions of this part, when compliance cannot be accomplished in any other way. The content of the text-only page shall be updated whenever the primary page changes.

(l) When pages utilize scripting languages to display content, or to create interface elements, the information provided by the script shall be identified with functional text that can be read by assistive technology.

(m) When a web page requires that an applet, plug-in or other application be present on the client system to interpret page content, the page must provide a link to a plug-in or applet that complies with §1194.21(a) through (l).

(n) When electronic forms are designed to be completed on-line, the form shall allow people using assistive technology to access the information, field elements, and functionality required for completion and submission of the form, including all directions and cues.

(o) A method shall be provided that permits users to skip repetitive navigation links.

(p) When a timed response is required, the user shall be alerted and given sufficient time to indicate more time is required.

Note to §1194.22:

1. The Board interprets paragraphs (a) through (k) of this section as consistent with the following priority 1 Checkpoints of the Web Content Accessibility Guidelines 1.0 (WCAG 1.0) (May 5, 1999) published by the Web Accessibility Initiative of the World Wide Web Consortium:

2. Paragraphs (l), (m), (n), (o), and (p) of this section are different from WCAG 1.0. Web pages that conform to WCAG 1.0, level A (i.e., all priority 1 checkpoints) must also meet paragraphs (l), (m), (n), (o), and (p) of this section to comply with this section. WCAG 1.0 is available at http://www.w3.org/TR/1999/WAI-WEBCONTENT-19990505.

§ 1194.31 Functional performance criteria.

(a) At least one mode of operation and information retrieval that does not require user vision shall be provided, or support for assistive technology used by people who are blind or visually impaired shall be provided.

(b) At least one mode of operation and information retrieval that does not require visual acuity greater than 20/70 shall be provided in audio and enlarged print output working together or independently, or support for assistive technology used by people who are visually impaired shall be provided.

(c) At least one mode of operation and information retrieval that does not require user hearing shall be provided, or support for assistive technology used by people who are deaf or hard of hearing shall be provided.

(d) Where audio information is important for the use of a product, at least one mode of operation and information retrieval shall be provided in an enhanced auditory fashion, or support for assistive hearing devices shall be provided.

(e) At least one mode of operation and information retrieval that does not require user speech shall be provided, or support for assistive technology used by people with disabilities shall be provided.

(f) At least one mode of operation and information retrieval that does not require fine motor control or simultaneous actions and that is operable with limited reach and strength shall be provided.

§ 1194.41 Information, documentation, and support.

(a) Product support documentation provided to end-users shall be made available in alternate formats upon request, at no additional charge.

(b) End-users shall have access to a description of the accessibility and compatibility features of products in alternate formats or alternate methods upon request, at no additional charge.

(c) Support services for products shall accommodate the communication needs of end-users with disabilities.

The following applications standards have been determined to not be applicable for this service:

§ 1194.23 Telecommunications products.

§ 1194.24 Video and multimedia products.

§ 1194.25 Self-contained, closed products.

§ 1194.26 Desktop and portable computers.

APPENDIX D

Voluntary Product Accessibility Template™

Version 1.2

The purpose of the Voluntary Product Accessibility Template, or VPAT™, is to assist Federal contracting officials and other buyers in making preliminary assessments regarding the availability of commercial "Electronic and Information Technology" products and services with features that support accessibility. It is assumed and recommended that Offerors will provide additional contact information to facilitate more detailed inquiries.

The first table of the Template provides a summary view of the section 508 Standards. The subsequent tables provide more detailed views of each subsection. There are three columns in each table. Column one of the Summary Table describes the subsections of subparts B and C of the Standards. The second column describes the supporting features of the product or refers you to the corresponding detailed table, "e.g., equivalent facilitation." The third column contains any additional remarks and explanations regarding the product. In the subsequent tables, the first column contains the lettered paragraphs of the subsections. The second column describes the supporting features of the product with regard to that paragraph. The third column contains any additional remarks and explanations regarding the product.

Date:

Name of Product:

Company contact for more Information:

Summary Table Voluntary Product Accessibility Template

Section 1194.21 Software Applications and Operating Systems

Section 1194.22 Web-based Internet Information and Applications

Section 1194.23 Telecommunications Products

Section 1194.24 Video and Multi-media Products

Section 1194.25 Self-Contained, Closed Products

Section 1194.26 Desktop and Portable Computers

Section 1194.31 Functional Performance Criteria

Section 1194.41 Information, Documentation and Support

Section 1194.21 Software Applications and Operating Systems – Detail Voluntary Product Accessibility Template™

(a) When software is designed to run on a system that has a keyboard, product functions shall be executable from a keyboard where the function itself or the result of performing a function can be discerned textually.

(b) Applications shall not disrupt or disable activated features of other products that are identified as accessibility features, where those features are developed and documented according to industry standards. Applications also shall not disrupt or disable activated features of any operating system that are identified as accessibility features where the application programming interface for those accessibility features has been documented by the manufacturer of the operating system and is available to the product developer.

(c) A well-defined on-screen indication of the current focus shall be provided that moves among interactive interface elements as the input focus changes. The focus shall be programmatically exposed so that Assistive Technology can track focus and focus changes.

(d) Sufficient information about a user interface element including the identity, operation and state of the element shall be available to Assistive Technology. When an image represents a program element, the information conveyed by the image must also be available in text.

(e) When bitmap images are used to identify controls, status indicators, or other programmatic elements, the meaning assigned to those images shall be consistent throughout an application's performance.

(f) Textual information shall be provided through operating system functions for displaying text. The minimum information that shall be made available is text content, text input caret location, and text attributes.

(g) Applications shall not override user selected contrast and color selections and other individual display attributes.

(h) When animation is displayed, the information shall be displayable in at least one non-animated presentation mode at the option of the user.

(i) Color coding shall not be used as the only means of conveying information, indicating an action, prompting a response, or distinguishing a visual element.

(j) When a product permits a user to adjust color and contrast settings, a variety of color selections capable of producing a range of contrast levels shall be provided.

(k) Software shall not use flashing or blinking text, objects, or other elements having a flash or blink frequency greater than 2 Hz and lower than 55 Hz.

(l) When electronic forms are used, the form shall allow people using Assistive Technology to access the information, field elements, and functionality required for completion and submission of the form, including all directions and cues.

Section 1194.22 Web-based Internet information and applications – Detail

(a) A text equivalent for every non-text element shall be provided (e.g., via "alt", "longdesc", or in element content).

(b) Equivalent alternatives for any multimedia presentation shall be synchronized with the presentation.

(c) Web pages shall be designed so that all information conveyed with color is also available without color, for example from context or markup.

(d) Documents shall be organized so they are readable without requiring an associated style sheet.

(e) Redundant text links shall be provided for each active region of a server-side image map.

(f) Client-side image maps shall be provided instead of server-side image maps except where the regions cannot be defined with an available geometric shape.

(g) Row and column headers shall be identified for data tables.

(h) Markup shall be used to associate data cells and header cells for data tables that have two or more logical levels of row or column headers.

(i) Frames shall be titled with text that facilitates frame identification and navigation

(j) Pages shall be designed to avoid causing the screen to flicker with a frequency greater than 2 Hz and lower than 55 Hz.

(k) A text-only page, with equivalent information or functionality, shall be provided to make a web site comply with the provisions of this part, when compliance cannot be accomplished in any other way. The content of the text-only page shall be updated whenever the primary page changes.

(l) When pages utilize scripting languages to display content, or to create interface elements, the information provided by the script shall be identified with functional text that can be read by Assistive Technology.

(m) When a web page requires that an applet, plug-in or other application be present on the client system to interpret page content, the page must provide a link to a plug-in or applet that complies with §1194.21(a) through (l).

(n) When electronic forms are designed to be completed on-line, the form shall allow people using Assistive Technology to access the information, field elements, and functionality required for completion and submission of the form, including all directions and cues.

(o) A method shall be provided that permits users to skip repetitive navigation links.

(p) When a timed response is required, the user shall be alerted and given sufficient time to indicate more time is required.

Note to 1194.22: The Board interprets paragraphs (a) through (k) of this section as consistent with the following priority 1 Checkpoints of the Web Content Accessibility Guidelines 1.0 (WCAG 1.0) (May 5 1999) published by the Web Accessibility Initiative of the World Wide Web Consortium: Paragraph (a) - 1.1, (b) - 1.4, (c) - 2.1, (d) - 6.1, (e) - 1.2, (f) - 9.1, (g) - 5.1, (h) - 5.2, (i) - 12.1, (j) - 7.1, (k) - 11.4.

Section 1194.31 Functional Performance Criteria – Detail Voluntary Product Accessibility Template™

(a) At least one mode of operation and information retrieval that does not require user vision shall be provided, or support for Assistive Technology used by people who are blind or visually impaired shall be provided.

(b) At least one mode of operation and information retrieval that does not require visual acuity greater than 20/70 shall be provided in audio and enlarged print output working together or independently, or support for Assistive Technology used by people who are visually impaired shall be provided.

(c) At least one mode of operation and information retrieval that does not require user hearing shall be provided, or support for Assistive Technology used by people who are deaf or hard of hearing shall be provided

(d) Where audio information is important for the use of a product, at least one mode of operation and information retrieval shall be provided in an enhanced auditory fashion, or support for assistive hearing devices shall be provided.

(e) At least one mode of operation and information retrieval that does not require user speech shall be provided, or support for Assistive Technology used by people with disabilities shall be provided.

(f) At least one mode of operation and information retrieval that does not require fine motor control or simultaneous actions and that is operable with limited reach and strength shall be provided.

Section 1194.41 Information, Documentation and Support – Detail

(a) Product support documentation provided to end-users shall be made available in alternate formats upon request, at no additional charge

(b) End-users shall have access to a description of the accessibility and compatibility features of products in alternate formats or alternate methods upon request, at no additional charge.

(c) Support services for products shall accommodate the communication needs of end-users with disabilities.

APPENDIX E

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 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.

5.

Within 72 hours of receipt by the Contractor's Contact of the Clearance Request Form, the Contractor shall provide a clearance 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.

6.

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.

7.

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 length of the contract and thereafter until either party notifies the other of its termination or Contractor provides to the FDA a different policy.

APPENDIX F

DATA DISCLOSURE CLEARANCE FORMS

APPENDIX G

Exchanging Certificates with the External Individual and FDA Secure Electronic Mail System

1. To obtain a commercial grade U.S. Domestic 1024-bit key certificate, the Contractor will need to send a signed message to the address securemail@fda.hh.gov with a subject line of External Secure Electronic Mail. Once the e-mail is received, an e-mail administrator will contact you with instructions on the next steps.

COR shall be responsible for follow up with the Contractor to assure that process is being adhered to in its entirety.

APPENDIX H

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.

1. Background: [ * ] has developed an internet-accessible or network-based 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.

2. 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.

3. 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.

4. 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 [ ** ].

5. 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.

6. 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

APPENDIX I

Site Information and Data Characteristics Table Hospital Inpatient and Emergency Department Drug Utilization Data and Treatment Procedures in short-stay and/or free-standing pediatric hospitals

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 inpatient and emergency department drug utilization data and treatment procedures in short-stay and/or free-standing pediatric hospitals

· Description of Contractor’s business that specifically details the percentage of data committed for hospital inpatient and emergency department drug utilization data and treatment procedures in short-stay and/or free-standing pediatric hospitals . 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, pediatric free-standing hospital versus standard, 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 inpatient and emergency department drug utilization data and treatment procedures in short-stay and/or free-standing pediatric 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 inpatient and emergency department drug utilization data and treatment procedures in short-stay and/or free-standing pediatric hospitals at the discharge-level and/or patient-level.

· Availability of age and gender of the patient at hospitalization and/or the ED visit.

· Availability of hospitalization and/or ED episode data

· Availability of data related to all drugs administered during the hospitalization and/or ED episode

· Availability of data related to treatment procedures shall be required for all procedures performed during the hospitalization and/or ED episode, and shall include the procedures coded in ICD and CPT/HCPCS codes

· Overall number of hospitals, as well as stand-alone pediatric 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 hospitalization and/or ED episode in the inpatient and emergency department setting for short-stay and/or free-standing pediatric 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 hospitalization or ED 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 hospitalization or ED 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 inpatient and emergency department setting for short-stay and/or free-standing pediatric 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 treatment procedures performed (procedure-specific and diagnosis-specific data elements) in the inpatient and emergency department 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]