HHSF223-R-1180161__Attachment_1_.pdf

Access to Over-the-Counter Drug Utilization Data

ACCESS TO OVER-THE-COUNTER (OTC) DRUG UTILIZATION DATA

Table of Contents

ATTACHMENT 1

STATEMENT OF WORK

1. Project Title: “Access to Over-the-Counter (OTC) Drug Utilization Data”

2. Background:

3. Program Research Goals and Objectives:

4. Scope of Work:

5 Special Contract Requirements:

ATTACHMENT 2

DELIVERABLES

ATTACHMENT 3

DATA CHARACTERISTICS TABLE

APPENDIX A

Glossary

APPENDIX B

Census Regions

APPENDIX C

Section 508 Standards

APPENDIX D

Voluntary Product Accessibility Template™

APPENDIX E

DATA DISCLOSURE CLEARANCE PROCEDURES

APPENDIX F

DATA DISCLOSURE CLEARANCE FORMS

APPENDIX G

Exchanging Certificates with the External Individual and FDA

APPENDIX H

Trial Subscription Agreement

ATTACHMENT 1

STATEMENT OF WORK

Note: All italicized terms are defined in the Glossary: (Appendix A)

1. Project Title: “Access to Over-the-Counter (OTC) Drug Utilization Data”

2. Background:

A vital part of FDA and CDER’s mission is to protect the public health. The mission of the Office of Surveillance and Epidemiology (OSE) is to evaluate drug risks and promote the safe use of drugs, prescription and over-the-counter (OTC), by the American people.

The statutory provisions of the Federal Food, Drug, and Cosmetic Act as amended by the

Food and Drug Administration Modernization Act (FDAMA, Section 406), Title 21 Code of Federal Regulations, Section 310.305, and Title 21 Code of Federal Regulations, Section 314.80 require FDA to ensure the safety and effectiveness of regulated marketed products.

The Office of Surveillance and Epidemiology (OSE) contributes to this effort by evaluating drug risks and promoting the safe use of drugs by the American people. Under

PDUFA (Prescription Drug User Fee Act) IV, specific provisions in Title IX of the Food and Drug Administration Amendments Act of 2007 (FDAAA 2007) contains numerous provisions related to post-marketing safety and communication of safety information. A subset of those provisions calls for enhanced authorities for accessing disparate data sources, establish and improve procedures to estimate the number of patients exposed to drugs nationwide.

In addition, the Center for Drug Evaluation and Research (CDER) initiated efforts to address concerns about the public health problem of liver injury related to the use of acetaminophen in both over-the-counter (OTC) and prescription (Rx) products following the June 29-30, 2009, Drug Safety and Risk Management Advisory Committee, Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs

Advisory Committee meeting. These efforts include changes in the dosing of acetaminophen along with increased education for prescribers and patients on the safe use of acetaminophen. As requested by the CDER Acetaminophen Steering Committee, the metrics working group (WG) developed an acetaminophen evaluation plan that will help to determine whether the changes, once implemented, have been effective in mitigating the adverse outcomes associated with the use of acetaminophen. The FDA plans to evaluate the effectiveness of the Acetaminophen Safe Use Initiative by monitoring relevant databases. In support of FDA’s effort, the Office of Surveillance and

Epidemiology identified the metrics and the timeline for monitoring, as well as the costs to

FDA to acquire these data.

The ability of FDA to respond expeditiously to the increasing number of drug safety issues is of paramount importance to the overall public safety. Continued direct access to

OTC drug utilization data will complement and strengthen the utility of FDA Adverse

Event Reporting System (FAERS) currently in place. Direct access to these data will also increase the FDA’s ability to perform regulatory impact studies; in particular, those studies that assess the impact of prescription to OTC drug switches, and also allow the

FDA to continue to evaluate the effectiveness of the Acetaminophen Safe Use Initiative by monitoring acetaminophen utilization patterns. Finally, direct access to these data in real-time enhances and accelerates the pace of FDA's regulatory decision-making process. The funding of "Access to Over-the-Counter (OTC) Drug Utilization Data" would serve as a mechanism for FDA to respond expeditiously to serious public health or regulatory issues related to OTC drug products.

FDA is not interested in developing this database and expects any qualified organization to own the data as well as the means to access the data.

FDA's authority to fund research projects is set out in section 301 of the Public Health

Service Act (PHSA 42 U.S.C. 241).

3. Program Research Goals and Objectives:

The Contractor shall provide FDA personnel with real-time, immediate, direct, multi-user, desktop access to a currently existing, commercially available data resource through an existing and user-friendly interface tool for Over-the-Counter (OTC) drug utilization data that include household and/or patient/intended user demographics, drug treatment patterns, and indications or ailments intended for treatment in the outpatient setting using surveys and/or other appropriate methodologies. This data resource shall have the capability of providing national patterns of OTC drug utilization patterns in the outpatient setting through the use of projection or other appropriate methodologies that are scientifically sound and transparent to FDA personnel.

4. Scope of Work:

The Contractor shall provide the necessary personnel, materials, services, facilities, and otherwise do all things necessary for or incident to the performance of the work as described below:

A. Data Requirements for Over-the-Counter (OTC) Drug Utilization Data:

Unlimited Access to OTC Drug Utilization Data

a. The Contractor shall provide continuous automated access to de-identified

HIPAA-compliant data resources on OTC drug product usage including, but not limited to household and/or patient/intended user demographics, drug treatment patterns, and indications or ailments intended for treatment in the outpatient setting. The source data can be obtained from a survey of household purchasing patterns or other electronic data sources. FDA requires access to such data to obtain national patterns of OTC drug product utilization. The data resource(s) shall have the capability of providing both current and historical national-level OTC drug product utilization. The data shall have a maximum of a 6-month lag time between the date of OTC drug product purchase and date of data availablility for FDA use.

b. The OTC drug utilization data shall include the number of households and/or patient/intended users, and household panel members and/or patient/intended users in the sample; characterization of households and/or patient/intended users in the sample in terms of number of individuals in the household, income level, and U.S. Census Region (Appendix B). The Contractor will provide a comparison to national figures.

c. The household and/or patient/intended user demographic data shall include the number and percent of patient populations of special interest to the FDA, including infants (<2 years), children (≤ 17 years), women of childbearing age

(12-45 years), adults (18-64 years), and elderly (≥ 65 years), the number and percent of patients missing age as well as the demographic distribution of patients (age and sex required and additional characteristics such as race and

U.S. Census Region).

d. The patient-specific basic data elements in the household shall include (but are not limited to): patient demographics of the patient/intended user such as age

(specify method by which age is obtained and how it is displayed in canned reports, i.e.,. standard age groups, customized age groups, single years), gender, and specify if other data elements are available, such as race/ethnicity;

income level; occupation; height and weight; clinical measures such as blood pressure, cholesterol, smoking status; alcohol use; availability of health insurance; and U.S. Census Regions.

e. The OTC drug-specific basic data elements shall include brand and generic drug products, including store name brand drug products; drug active ingredients; unit price code (UPC) and/or national drug code (NDC) number;

strength of active ingredients; dosage form; size of drug product by milliliter

(mL), number of tablets/capsules, and/or total doses available; manufacturer and/or re-packager; date of purchase; indication(s) for use or ailment(s) intended to treat or an acceptable surrogate such as therapeutic sub-categories, and source of drug (recommendation by healthcare professional, self-purchase, sample provided). The Contractor shall provide the percentage of missing or incomplete data or information for each of these OTC drug-specific basic data elements. Of note, specific store names for store name brand products are not required but data on store name brand products, such as drug active ingredients, shall be included for analysis by the elements listed above.

f. The treatment-specific basic data elements shall describe the patient’s ailment treatment category; concomitant use with other prescription or OTC drug products; duration of use; diagnosis code such as ICD-9/ICD-10 and date of diagnosis; and the patient demographics of the patient/intended user.

g. The data resource shall include a coding system that consists of drug and ailment coding levels for FDA data analyses; and if available, quantify the amount, frequency, and duration of OTC drug products used as well as the ailment intended to treat in the outpatient setting and the percentage of missing or incomplete information for each data element. For examining data on treatment of specified ailment or medical conditions, the data resource shall capture the OTC drugs purchased as well as other drugs used for the treatment of the ailment.

h. The existing user interface tool of the data resource(s) shall provide FDA staff the ability to select OTC drugs and market categories, and perform data reports at the active ingredient level, generic and brand products (including store name brand products), and any other data elements that may become available. The user interface tool(s) shall provide FDA staff the ability to perform data reports without or with minimal intervention by the Contractor and download in near real-time.

i. The Contractor shall de-identify the data for FDA use, and the methods used to de-identify the data shall be described in the proposal and shall be HIPAA-compliant.

B. Data Requirements for Over-the-Counter (OTC) Drug Utilization Data:

Projection or Other Appropriate Methodology

a. The Contractor shall project the data to the national level using a FDA approved projection or other appropriate methodology, which shall be valid, reliable, and robust with regard to OTC drug product purchase and use specifically, and the methods fully disclosed. Results from projections shall be comparable to estimates obtained from national benchmarks such as the

U.S. National Census Data. The data resource(s) shall have raw/sample and projected numbers. The Contractor shall provide the frequency with which data are updated and methods for updates.

b. The Contractor shall provide full disclosure of data collection, construction, coding, and configuration to allow FDA staff to appropriately interpret findings and understand the construction and application of the projection or other appropriate methodology.

C. Complete Data Dictionary for Over-the-Counter (OTC) Drug Utilization Data

Resource

The Contractor shall provide a current and complete data dictionary, including updates, and a description of their data resource(s), type of data, the data collection methodology, and the data elements demonstrating that the data resource(s) can evaluate OTC drug utilization data at the national level.

D. Technical Requirements and Capabilities of the Data Resources

a. The Contractor shall provide OTC drug utilization data that is currently existing and commercially available. Access to the data shall be immediate, unlimited, direct, via desktop and in real-time. Direct access shall include all upgrades, enhancements, and modifications to software and data.

Direct access shall be through an existing interface. This interface shall be user-friendly, transparent, and flexible to meet the FDA’s needs and provide

FDA staff the ability to select drugs and perform data reports by active ingredient, generic and brand products (including store name brand), and any other data elements that may become available, and download in near real-time manner and without or with minimal intervention by the Contractor.

Minimally, the interface shall provide both predefined (e.g., canned) and custom reports (eg. customized age groups). Direct access to the data resource(s) shall include the ability to download (or obtain in near real-time manner using other means) and analyze patient level data (as soon as available). FDA’s preference is that unrestricted direct access to datasets shall be available on demand and without intervention by the Contractor.

b. The FDA shall purchase one site license for 20 certified users with option for up to 10 additional users. Individuals within the Office of Surveillance and

Epidemiology as well as other authorized users within the FDA will need to access these data for their work.

c. The Contractor shall provide the FDA the ability to directly download or export data in SAS, MS Excel, or MS Access, in addition to ASCII format, from the Contractor’s interface to FDA’s external storage device and/or directly to the FDA server.

d. The Contractor shall provide access to the data resource(s) via a secure

Internet or network-based method permitting simultaneous, multi-user access through a user friendly data query tool(s). Access to the data resource(s) shall be through a wide area network with transmission control protocol/Internet protocol (TCP/IP) running on a 10/1000 Mbs network. The network-based methods shall not necessitate any additions to the FDA communications infrastructure. FDA shall not support modem-based or dial-up access.

Additionally, FDA shall not support or maintain Contractor’s equipment or personnel on premises. The FDA standard browser package is Microsoft

Internet Explorer Version 11.x and Firefox 24.x.

e. The Contractor shall specify any additional software and/or hardware (name and version) necessary to access the data. Any software installed on FDA computers for the purposes of accessing the data shall not use key-logging and/or network capturing functionality to transmit any data from the FDA system except for login information specific to the data and data (eg. SQL queries or similar methods) accessing the Contractor’s application data sets.

f. The Contractor shall participate in the CDER secure electronic mail system

(See Appendix G) to protect any sensitive data which may be transmitted electronically between the data vendor and the FDA. The FDA utilizes the virtual private network (VPN) to establish a trusted, encrypted TCP/IP tunnel for accessing data from a remote location. The virtual private network shall be a firewall-to-firewall encrypted tunnel utilizing commercially available software and industry standard IPSEC protocols. The Contractor shall conform to Section 508 standards. (See Appendix C)

E. Data Requirements for OTC Drug Utilization Data: Ad Hoc Data Analyses

The Contractor shall provide additional ad hoc data analyses or custom queries or product customization not available through the data tools not to exceed 200 man-hours per year.

F. Onsite Training Programs and Training Materials

The Contractor shall provide training for users of the data, as well as training for

FDA personnel who will support use of the data (e.g., technical users). The

Contractor shall provide a minimum of two onsite training sessions per year.

The training sessions shall include an instructor led overview of the OTC data resource to the FDA staff with the ability to project via web-based presentation. A hands-on computer-based training for a maximum of 18 FDA staff members shall be provided on the use of the data and interface tool(s). The hands-on sessions shall include exercises with data queries with FDA content. The Contractor shall work with FDA COR to develop exercises with data queries relevant to FDA work.

The Contractor shall provide options for additional “on-demand” sessions via web-based methods. Training shall be initiated within 30 days of award and shall continue throughout the duration of the contract.

The Contractor shall provide course outlines to include a detailed training agenda

(pre-approved by FDA) for the overview of the OTC data resource(s) and the hands-on computer-based training offered. Training manuals and course outlines shall be provided in hard-copy at the time of training.

G. Onsite Kick-Off and Annual Meeting

The Contractor shall participate in a kick-off meeting within two weeks of award and shall conduct an annual meeting on-site at the FDA campus in Silver Spring, MD once a year. The purpose of the annual meeting is to discuss scientific issues of interest to the Agency and relevant work that the Contractor has performed, as well as discussing FDA satisfaction with all deliverables.

H. Technical Support Requirements – Support Package – Technical Analytical and Clinical; Data and Software Upgrades and New Releases; Monthly Usage

Reports

The Contractor shall provide a support package comprised of web-based written documentation that includes technical, analytical, and clinical support throughout the length of the contract.

The Contractor shall provide ongoing technical, analytical, and clinical support, by phone or by e-mail, to all certified users of the data during business hours (9:00 am to 5:00 pm, EST), throughout the length of the contract in accordance with the service levels established in the contract.

The support package shall include all upgrades, enhancements, and modifications to the software and data.

I. Monthly Reports (See Attachment 8)

The Contractor shall provide a Monthly Report by the 30 th of each month to the COR and shall include:

1. Monthly Usage Report: to include the number of data queries per approved

Certified User

2. Ad Hoc Dataset Requests: to include the number of technical support programming hours used

3. Clearance Requests: to include data submitted, project title, purpose

(publication, presentation, research, or other), FDA requestor, and approval date

4. Third Party Agreement Requests: to include third party collaborator, FDA principal investigator, approval date, expiration date, and project title

5. Notifications of any circumstances resulting in loss of, or lack of data streams, or any data errors that would impact access to data from the data resource(s).

J. Disclosure Clearance Services

a. Disclosure Clearance Services

The Contractor shall provide disclosure clearance services for FDA to use aggregated data in scientific and technical articles, study results, presentations, and public health advisories for these purposes outside of the Agency including the general public. The Contractor shall accept and adhere to the FDA Data

Disclosure Clearance Procedures and form found in Appendices E and F.

The FDA will notify the Contractor for a period of one year after Option Period 2 for aggregated data release to entities outside of the Agency and accept the

Contractor’s requested revisions, but will not require formal approval for release.

b. Clearance for Third Party Collaborations

The Contractor shall provide Third Party Collaborations in support of collaborative research projects with third parties outside of FDA that are initiated by and for the benefit of FDA. These collaborations shall require FDA to have the ability to share project specific aggregated or raw data with third parties for collaborative research projects. For these collaborations that require sharing of aggregated or raw data, the Contractor shall accept and adhere to the Data

Disclosure Clearance Procedures and form found in Appendices E and F unless a different Data Disclosure Clearance Procedure process proposed by the Offeror is approved in advance by the FDA. These Procedures include terms and conditions for third party collaborations.

K. Indefinite Delivery, Indefinite Quantity (IDIQ) Services Associated with the

Scope of Work

The Contractor shall provide unlimited additional quantities of services via the issuance of firm fixed priced individual Task Orders at the unit price negotiated for each TO within the description of work. The performance period/delivery date(s) for services ordered shall be specified on each individual TO. The ceiling total amount of all TOs shall not exceed $4,000,000.00 over the total period of performance (Base and Option Periods).

The type of additional services and associated maintenance shall include, but are not limited to:

1. Concomitant drug reports – reports on the concomitant use of an OTC product(s) or class of products with another product(s) or class of products used to treat an ailment.

2. Feasibility studies - studies that are conducted as initial pilot studies to determine if the scope of a study is practical, achievable and likely to involve a large population size to determine a significant association or non-significance association between exposure and outcome.

3. Customized analysis – analysis of data that endeavor to answer a specific question that require additional tools beyond the current interface tool that is provided by the database.

4. Risk management studies – studies that endeavored to ascertain if a specific risk management program is effective to ensure that the benefits of the drug outweigh the risks.

5. Training services – training staff for a specific service. For example, training medical records abstractors on the pertinent information required for abstracting medical record data based on medical record abstraction form.

6. Configuration of user interface tool – optimize configuration of user interface tool to provide FDA staff the ability to select drugs and perform data reports by active ingredient, generic and brand name, and any other data elements that may become available, and download in a timely manner and without or with minimal intervention by the Contractor.

7. Ad Hoc Analyses – The Contractor shall provide additional hours of ad hoc data analyses or custom queries not available through the data tools and in increments of 50 hours.

L. Contracts Management Requirements

Quality Assurance Surveillance Plan: The Contractor shall provide a Quality Assurance

Surveillance Plan (QASP) plan detailing procedures and guidelines to ensure the required performance standards or services levels are met throughout the life of this contract. The

QASP shall describe the systematic methods used to monitor performance, identify required documentation, and allocate resources. The Government reserves the right to alter or change the surveillance methods in the QASP at its own discretion.

Performance Evaluation Plan: Performance shall be evaluated to determine whether or not it meets the threshold of the agreement. When the performance threshold is not met, the FDA Contracting Officers Representative (COR) will notify the Contracting Officer.

The Contractor shall reply to all performance inquiries listed below with a resolution within 15 business days of receipt. Failure to meet the Acceptable Quality Level shall be captured as non-performance and provided to the Contracting Officer for action.

Performance Requirements Summary Table (PRST): The purpose of this section is to define performance evaluation procedures.

Required Service Standard Acceptable

Quality

Level

(AQL)

Method of Surveillance

The successful

Contractor shall provide Disclosure

Clearance and

Third Party

Agreement Service

The turnaround time for urgent clearance requests is 24 hours; 48 hours for standard clearance

Standard shall be fully met at

100%

COR and FDA staff shall maintain a clearance tracking log with turnaround times

Level

(AQL)

Method of Surveillance requests; and

72 hours for third-party agreements

The successful

Contractor shall provide Unlimited

Direct Access to

Data Resource and

Services

The Contractor shall notify the

FDA 48 hours in advance of any circumstances resulting in loss of access to the data source due to planned downtime.

The Contractor shall notify the

FDA within 30 minutes

(Monday-

Friday, 9:00

AM – 5:00 PM

Eastern Time) from the onset of unplanned downtime with an estimate of time as to restoration of access

Standard shall be fully met at

100%

COR and FDA staff shall monitor database access, notification and restoration times

The successful

Contractor shall provide Ad-hoc

Analyses: custom reporting and product customization

The Contractor shall provide the FDA ad-hoc data results within 15 business days of receipt

Standard shall be fully met at

100%

COR and FDA staff shall monitor turnaround times from the Contractor’s monthly report

Level

(AQL)

Method of Surveillance

The successful contractor shall provide a resolution plan and shall include a timeline for resolving any circumstances resulting in loss of, or lack of, access to data or any data errors/loss from the database(s)

Within five business days of

Contractor’s knowledge of the loss or lack of access to data or any data errors/loss from the database(s) and shall be documented in the Monthly

Report

Standard shall be fully met at

100%

COR and staff review of data quality (i.e., variance in data runs)

5 Special Contract Requirements:

Advance Understanding

Notwithstanding any of the above provisions, under certain circumstances, the

Government may be required to share data or information it obtains under this contract with Congress, with a Federal court, or with another Governmental body of competent jurisdiction. If it intends to share data or information obtained under this contract with

Congress, with a Federal court, or with another Governmental body of competent jurisdiction, the Government will take appropriate measures within its control in an effort to ensure that the information will be shared in a manner intended to protect the information from public disclosure.

The Contractor shall assure the protection of the information and data they receive under this contract from unauthorized use or disclosure, and shall treat the information as confidential or otherwise privileged.

ATTACHMENT 2

DELIVERABLES

BASE PERIOD September 25, 2017 through September 24, 2018

Item No. Description of Supplies/Service Quantity Unit Delivery Date

Unlimited Access to Over-the-

Counter (OTC) Drug Utilization

Data

Unlimited 12 months Continuously through the Period of Performance

Acceptable Projection or Other

Appropriate Methodology (1 Lot)

1 Lot Within 2 weeks of contract award

Current and complete Data

Dictionary, including updates (1 Lot)

1 Lot Within 2 weeks of contract award

Kick Off Meeting (1 Lot) 1 Lot Initiated within 2 weeks of award

On-site training programs and training materials (2 annually)

2 Lot First training course provided within 30 days of award and second training course within 6 months

Technical Support; to include

Notification of and Access to

Upgrades and/or New Releases of the

Data and Software

Unlimited 12 months Continuously through the Period of Performance

Disclosure Clearance and Third Party

Agreement Services

Unlimited 12 months Within 48 hours

(24 hours for urgent requests) for clearances and 72 hours of receipt for

Third Party

Agreements

Monthly Reports by the 30th of each month (12 monthly)

12 12 months 30 th of each month

0002 Ad hoc analyses: custom reporting 200 Hours Continuously through the Period of Performance

OPTION PERIOD 1 September 25, 2018 through September 24, 2019

Counter (OTC) Drug Utilization

Unlimited 12 months Continuously

Data of Performance

Acceptable Projection or Other

Appropriate Methodology (1 Lot)

1 Lot Within 30 days of

Option Period 1 award

Current and complete Data

Dictionary, including updates (1 Lot)

1 Lot Within 30 days of

Option Period 1 award

Annual Meeting (1 annually) 1 Lot Annually within 3 months of exercising Option

Period 1

On-site training programs and training materials (2 annually)

2 Lot Twice a year in 6 month intervals

Technical Support; to include

Notification of and Access to

Upgrades and/or New Releases of the

Data and Software

Unlimited 12 months

Continuously of Performance

Disclosure Clearance and Third Party

Agreement Services

Unlimited 12 months Within 48 hours

(24 hours for urgent requests) for clearances and 72 hours of receipt for

Third Party

Agreements

Monthly Reports by 30 th of each month (12 monthly)

12 12 months 30 th of each month

1002 Ad hoc analyses: custom reporting 200 Hours Continuously

OPTION PERIOD 2 September 25, 2019 through September 24, 2020

Counter (OTC) Drug Utilization

Data

Unlimited 12 months Continuously through the Period of Performance

Acceptable Projection or Other

Appropriate Methodology (1 Lot)

1 Lot Within 30 days of

Option Period 2 award

Current and complete Data

Dictionary, including updates (1 Lot)

1 Lot Within 30 days of

Option Period 2 award

Annual Meeting (1 annually) 1 Lot Annually within 3 months of exercising Option

Period 2

On-site training programs and training materials (2 annually)

2 Lot Twice a year in 6 month intervals

Technical Support; to include

Notification of and Access to

Upgrades and/or New Releases of the

Data and Software

Unlimited 12 months

Continuously of Performance

Disclosure Clearance and Third Party

Agreement Services

Unlimited 12 months Within 48 hours

(24 hours for urgent requests) for clearances and 72 hours of receipt for

Third Party

Agreements

Monthly Reports by 30 th of each month (12 monthly)

12 12 months 30 th of each month

2002 Ad hoc analyses: custom reporting 200 Hours Continuously

IDIQ ITEMS/SERVICES

Base Period of Performance: September 25, 2017 through September 24, 2018

Item No. Description of Supplies/Service Quantity Unit

0003 Labor Category TBD Hourly

0004 Additional Services (customized analysis) TBD Each/Hourly

0005 Configuration of user interface tool TBD Each/Hourly

0006 Ad hoc analysis: custom reporting 50 Hours Hourly

IDIQ ITEMS/SERVICES

Option Period 1 of Performance: September 25, 2018 through September 24, 2019

Item No. Description of Supplies/Service Quantity Unit

1003 Labor Category TBD Hourly

1004 Additional Services (customized analysis) TBD Each/Hourly

1005 Configuration of user interface tool TBD Each/Hourly

1006 Ad hoc analysis: custom reporting 50 Hours Hourly

IDIQ ITEMS/SERVICES

Option Period 2 of Performance: September 25, 2019 through September 24, 2020

Item No. Description of Supplies/Service Quantity Unit

2003 Labor Category TBD Hourly

2004 Additional Services (customized analysis) TBD Each/Hourly

2005 Configuration of user interface tool TBD Each/Hourly

2006 Ad hoc analysis: custom reporting 50 Hours Hourly

ATTACHMENT 3

DATA CHARACTERISTICS TABLE

OTC Data Characteristics Table

Overall Population and Data Characteristics:

Month and year of when data collection began

Overall number of households and/or patient/intended users represented in the entire database.

The number of households and/or patient/intended users, by calendar year (indicate trend breaks and major changes in data collection methodology)

Characterization of households in terms of number of patient/intended users, income level, and U.S.

Census Region.

Number and percentages of each of the following populations in the database:

Children [0 – 17 years]

Women of childbearing age [12 – 45 years]

Adults [18 -64 years]

Older individuals [65 years and older]

Number and percent of patients missing age

Availability of patient data by U.S. Census Region [Y/N]

Frequency of database updates

Lag time between data collection and availability of data for analysis

Generally accepted coding system(s) for drugs and medical products (e.g. NDC) used in data resource, if any. (Please list)

Complete data dictionary (including percentage of missing data) and a description of the data resource(s)

Raw/sample numbers, as well as projected numbers, if available

Availability of patient demographics and basic data (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)

Gender (Y/N)

Race/ethnicity (Y/N)

Income level (Y/N)

Occupation (Y/N)

Height (Y/N)

Weight (Y/N)

Clinical measures, i.e., blood pressure (Y/N)

Smoking status (Y/N)

Alcohol use (Y/N)

Availability of health insurance (Y/N)

U.S. Census Region (Y/N)

Availability of drug-specific data elements: (Specify the following and provide percentage missing for each item):

Brand and generic drug products, including store name brand drug products (Y/N)

Drug product name (Y/N)

Drug active ingredients (Y/N)

Unit Price code (UPC) and/or national drug code (NDC) number (Y/N)

Strength of active ingredients (Y/N)

Drug formulation (Y/N)

Size of drug product by mL, number of tablets/capsules, and/or total doses available (Y/N)

Indication(s) for use or ailment(s) intended to treat (Y/N)

Manufacturer and/or re-packager (Y/N)

Date of purchase (Y/N)

Total dose per day (Y/N)

Source of drug (e.g., recommendation by healthcare professional, self-purchase, sample provided)

(Y/N)

Availability of treatment-specific data elements: (Specify the following and provide percentage missing for each item):

Patient’s ailment treatment category (Y/N)

ICD-9 diagnosis code (Y/N)

ICD-10 diagnosis code (Y/N)

Concomitant use with other prescription or OTC drug products (Y/N)

Date of diagnosis (Y/N)

Total dose per day (Y/N)

Duration of medication consumption (in days, months, years) (Y/N)

APPENDIX A

Glossary

Aggregated data – High-level collective data or summary data that does not disclose any raw data.

Commercially available – The data resource, or access to it, is available for sale or has been sold to the general public. (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 – A patient’s key information, e.g., name, address, social security number, and date of birth, has been removed to ensure that any user or audience shall not purposefully or inadvertently discover a patient’s identity. However, tracking capability shall be required regarding a single individual (e.g. patient A), across multiple encounters over time and differentiating one individual from another individual (e.g. patient B).

Demographics – 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 with written authorization to disclose information from this resource in public forums, or sharing collaborative projects initiated by FDA with third parties 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.

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

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

HIPAA compliant – 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.

Multi-user environment – Two or more authorized FDA users shall be able to access the data at the same time from different locations.

Outpatient – Any place where health care is received without being admitted to the hospital as an inpatient. (NB: Day surgery, ambulatory care centers, and other outpatient services provided by hospitals may be considered to be within the outpatient setting.)

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 OTC product sales and use (e.g., a “Census” method including strata), which may reduce or eliminate the need for projection. Should a “Census” method be chosen, the Offeror shall provide mutually acceptable evidence that the data are adequately representative of outpatient drug utilization in the U.S.

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 direct 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.

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:

Section 1194.22 Paragraph WCAG 1.0 Checkpoint

(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

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.

http://www.w3.org/TR/1999/WAI-WEBCONTENT-19990505

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 offerers 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.