FDA-RFP-17-1179520.pdf

FDA Support Services: Access to Data on Pharmaceutical Sales

PART 1- DESCRIPTION

1.1 Solicitation Description

Solicitation number FDA-RFP-17-1179520 is issued as a Request for Proposal (RFP).

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information from FAR Part 13.5 and included in this notice. The resultant task orders will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-95. The North American Industrial Classification System (NAICS) code for this procurement is 541990, All Other Professional, Scientific, and Technical Services.

1.2 Type of Contract

The Government intends to award a hybrid Firm-Fixed-Price, Labor Hour and Indefinite Delivery/Indefinite Quantity (IDIQ) contract vehicle for a duration of five (5) years, consisting of one (1) base year, and four (4) optional periods. The IDIQ portion of the contract intends to issue Firm-Fixed-Price, and Labor Hour Task Orders.

The IDIQ guaranteed minimum amount will be the amount of the award fixed price portion of the contract. The contract maximum ceiling amount for the IDIQ portion will be $850,000.00 over five (5) years, inclusive of options.

PART 2- SUPPLIES OR SERVICES AND PRICES/COSTS

2.1 Description of Services and Supplies

The Food and Drug Administration’s Center for Drug Evaluation and Research has a need for access to national-level pharmaceutical sales data.

2.2 Pricing Schedule

The pricing schedules are broken down in the tables below as follows:

BASE YEAR

CLIN Description of Supplies/Service Qty Unit Total Price

0001 U.S. Pharmaceutical Market – Retail/Non-Retail Data (Unlimited Access License) 80 Users.

1 Twelve (12) Months

0002 Disclosure Clearance and Third Party Agreement, Acceptable Projection or Other Appropriate Methodology, Current and complete Data Dictionary, and Technical

1 Lot

Support (Inclusive of Notification of and Access to Upgrades and/or new releases of the data and software).

0003 On-site training programs and training materials

2 Lot

0004 Annual Meeting 1 Lot 0005 Monthly Usage Reports 12 Lot 0006 Ad-hoc Analyses: Custom reporting and Product Customization 50 Hours

0007 Option Quantity: U.S.

Pharmaceutical Market – Retail/Non-Retail Data (Unlimited Access License) Ten (10) Additional Users

12 Months.

0008 Option Quantity: U.S.

Pharmaceutical Market – Retail/Non-Retail Data (Unlimited Access License) Ten (10) Additional Users

12 Months.

Base Year Total Firm Fixed Price

OPTION YEAR 1

CLIN Description of Supplies/Service Qty Unit Total Price

1001 U.S. Pharmaceutical Market – Retail/Non-Retail Data (Unlimited Access License) 80 Users.

1002 Disclosure Clearance and Third

Projection or Other Appropriate Methodology, Current and complete Data Dictionary, and Technical Support (Inclusive of Notification of and Access to Upgrades and/or new releases of the data and software).

1 Lot

1003 On-site training programs and training materials

2 Lot

1004 Annual Meeting 1 Lot 1005 Monthly Usage Reports 12 Lot 1006 Ad-hoc Analyses: Custom reporting and Product Customization 50 Hours

1007 Option Quantity: U.S.

Pharmaceutical Market – Retail/Non-Retail Data (Unlimited Access License) Ten (10) Additional Users

Months.

1008 Option Quantity: U.S. 1 Twelve (12)

Pharmaceutical Market – Retail/Non-Retail Data (Unlimited Access License) Ten (10) Additional Users

Months.

OPTION YEAR 1 Total Firm Fixed Price

OPTION YEAR 2

CLIN Description of Supplies/Service Qty Unit Total Price

2001 U.S. Pharmaceutical Market – Retail/Non-Retail Data (Unlimited Access License) 80 Users.

2002 Disclosure Clearance and Third

Projection or Other Appropriate Methodology, Current and complete Data Dictionary, and Technical Support (Inclusive of Notification of and Access to Upgrades and/or new releases of the data and software).

1 Lot

2003 On-site training programs and training materials

2 Lot

2004 Annual Meeting 1 Lot 2005 Monthly Usage Reports 12 Lot 2006 Ad-hoc Analyses: Custom reporting and Product Customization 50 Hours

2007 Option Quantity: U.S.

Pharmaceutical Market – Retail/Non-Retail Data (Unlimited Access License) Ten (10) Additional Users

2008 Option Quantity: U.S.

Retail/Non-Retail Data (Unlimited Access License) Ten (10) Additional Users

OPTION YEAR 2 Total Firm Fixed Price

OPTION YEAR 3

CLIN Description of Supplies/Service Qty Unit Total Price

3001 U.S. Pharmaceutical Market – Retail/Non-Retail Data (Unlimited Access License) 80 Users.

3002 Disclosure Clearance and Third

Projection or Other Appropriate Methodology, Current and complete

1 Lot

Data Dictionary, and Technical Support (Inclusive of Notification of and Access to Upgrades and/or new releases of the data and software).

3003 On-site training programs and training materials

2 Lot

3004 Annual Meeting 1 Lot 3005 Monthly Usage Reports 12 Lot 3006 Ad-hoc Analyses: Custom reporting and Product Customization 50 Hours

3007 Option Quantity: U.S.

Pharmaceutical Market – Retail/Non-Retail Data (Unlimited Access License) Ten (10) Additional Users

3008 Option Quantity: U.S.

Retail/Non-Retail Data (Unlimited Access License) Ten (10) Additional Users

OPTION YEAR 3 Firm Fixed Price

OPTION YEAR 4

CLIN Description of Supplies/Service Qty Unit Total Price

4001 U.S. Pharmaceutical Market – Retail/Non-Retail Data (Unlimited Access License) 80 Users.

4002 Disclosure Clearance and Third

Projection or Other Appropriate Metholodgy, Current and complete Data Dictionary, and Technical Support (Inclusive of Notification of and Access to Upgrades and/or new releases of the data and software).

1 Lot

4003 On-site training programs and training materials

2 Lot

4004 Annual Meeting 1 Lot 4005 Monthly Usage Reports 12 Lot 4006 Ad-hoc Analyses: Custom reporting and Product Customization 50 Hours

4007 Option Quantity: U.S.

Pharmaceutical Market – Retail/Non-Retail Data (Unlimited

Access License) Ten (10) Additional Users

4008 Option Quantity: U.S.

Pharmaceutical Market – Retail/Non-Retail Data (Unlimited Access License) Ten (10) Additional Users

OPTION YEAR 4 Total Firm Fixed Price

TOTAL CONTRACT VALUE

BASE PERIOD TOTAL PRICE

OPTION YEAR 1 TOTAL PRICE

OPTION YEAR 2 TOTAL PRICE

OPTION YEAR 3 TOTAL PRICE

OPTION YEAR 4 TOTAL PRICE

TOTAL FIRM FIXED PRICE

IDIQ Other Services

The pricing chart below outlines all of the labor categories that shall be required throughout the life of the contract.

The Contractor shall provide services in accordance with the Statement of Work at fixed hourly rates.

(Fully Burdened Labor Rates)

Labor Rate Pricing Chart: Labor

Category Hourly Rate Estimated # of

Hours per Year

Total Rate X #Hours

Project Manager Base Year $ 1040 $

Option Year 1 $ 1040 $ Option Year 2 $ 1040 $ Option Year 3 $ 1040 $ Option Year 4 $ 1040 $ Senior Computer Analyst Base Year $ 1040 $

Option Year 1 $ 1040 $ Option Year 2 $ 1040 $ Option Year 3 $ 1040 $ Option Year 4 $ 1040 $

Application Programmer Base Year $ 1040 $

Option Year 1 $ 1040 $ Option Year 2 $ 1040 $ Option Year 3 $ 1040 $ Option Year 4 $ 1040 $ Statistician Base year $ 1040 $

Option Year 1 $ 1040 $ Option Year 2 $ 1040 $ Option Year 3 $ 1040 $ Option Year 4 $ 1040 $

Pharmacist Base Year $ 1040 $

Option Year 1 $ 1040 $ Option Year 2 $ 1040 $ Option Year 3 $ 1040 $ Option Year 4 $ 1040 $ Senior Training Specialist Base Year $ 1040 $

Option Year 1 $ 1040 $ Option Year 2 $ 1040 $ Option Year 3 $ 1040 $

Option Year 4 $ 1040 $ Computer Programmer Base Year $ 1040 $

Option Year 1 $ 1040 $ Option Year 2 $ 1040 $ Option Year 3 $ 1040 $ Option Year 4 $ 1040 $

PART 3- DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

3.1 Background

A vital part of FDA and CDER’s mission is to promote and protect the public health. Offices within CDER take a variety of approaches to meet these broad goals. For example, the Office of Surveillance and Epidemiology (OSE) evaluates drug risks and promotes the safe use of drugs by the American people. The Drug Shortage Staff (DSS) aims to minimize the impact of shortages of drug products, by working to avoid such shortages or to mitigate the effects when shortage is unavoidable. Finally, the Office of Program and Strategic Analysis (OPSA) conducts economic and quantitative analyses of proposed and existing policies.

To fulfill these missions and other program functions, CDER requires access to national-level pharmaceutical sales data and, as needed, international data to estimate and forecast trends in pharmaceutical sales, pricing, and volume of distribution throughout various settings of care. Continued access to these data allows the FDA to respond expeditiously to questions relating to drug safety, the impact of regulatory policies, and to potential drug shortage situations, helping the Agency to make more informed decisions about matters that affect the health of Americans.

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.

In early 2005, FDA commissioned the Institute of Medicine (IOM) to conduct a study to examine the U.S. drug safety system. In September 2006, the IOM report entitled, “The Future of Drug Safety:

Promoting and Protecting the Health of the Public” was released and outlined numerous ongoing and future activities designed to continue to strengthen the FDA’s drug safety program. OSE contributes to this effort by evaluating drug risks and promoting the safe use of drugs by the American people. Specific recommendations in the IOM report addressed modernizing the drug safety program including activities for the expansion of database resources.

In addition, 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 and establishing and improving procedures to identify drug use data trends on a national level.

The ability of FDA to respond expeditiously to the increasing number of post-marketing issues is of paramount importance to the overall public safety. Continued access to these data complement and strengthen the utility of the passive reporting system currently in place by providing broad estimates of how drugs are sold to all types of institutions in the health system. These data resources also provide a denominator, or context, for understanding adverse event reports; for modeling drug risks based on usage patterns; and for calculating patient-based, adverse event reporting rates for drugs.

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).

3.2 Objectives

Program Research Goals:

To provide FDA personnel with:

A. Real-time, unlimited, immediate, direct, multi-user, desktop access to currently existing, commercially available data on pharmaceutical sales. Updated information on sales shall be available at least as frequently as a monthly basis, and historical sales data shall also be available for trending and forecasting

B. The ability to use these data to analyze and describe national patterns of pharmaceutical sales through the use of projection or other appropriate methodologies that are scientifically sound and transparent to FDA personnel

C. Sufficient granularity of pharmaceutical sales information to obtain data on product- and substance-specific pharmaceutical sales to health care settings and facilities by channels of distribution.

3.3 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.

3.3.1 Pharmaceutical Sales Data Requirements

For the purpose of this requirement, the data resource(s) shall be sufficient to meet FDA’s need to access national-level pharmaceutical sales data. The data resource(s) shall capture sales that occur through all types of distribution arrangements, including wholesalers as well as direct-buy with manufacturers.

These data resource(s) shall further allow sales data to be broken down by channels of distribution (e.g., retail, mail-order, long-term care, for-profit and not-for-profit, federal and non-federal, clinics, institutional/non-institutional, specialty pharmacies, etc.) and by U.S. geographic regions. These data resource(s) shall also include measure(s) for the volume of pharmaceutical product sales (dollars, units, SKU, etc.) by manufacturer, and the ability to obtain raw/sample numbers as well as projected numbers.

These data resource(s) shall have basic data elements to capture company, drug, and pricing information. These data shall be provided in monthly and annual increments for all prescription and non-prescription, generic, brand and over-the-counter (OTC) drugs and biologics. These data resource(s) shall have raw/sample numbers, projected numbers, and confidence intervals available, with immediate access if possible, throughout the length of the contract.

The company-specific data elements shall include (but are not limited to): name of corporation (parent company); name of manufacturer/distributor (marketing company); and company size indicators (e.g., total products, sales, gross profit, revenue, etc.). DUNS numbers (or other unique company identifiers) of the marketing company shall also be included (preferred).

The drug-specific data elements shall include for all prescription, brand, generic and OTC drugs and biologic products(including biosimilars): product names (U.S. proprietary and non-proprietary); volume measures (e.g., packages, units, extended units, SKU, etc.); name of corporation/manufacturer, include brand status (brand, generic and branded generic), Rx status (Rx, OTC); originator status (e.g., originator, re-packager, branded or private label, etc.);

molecule(s); active ingredient(s); chemical family; composition (e.g., single-ingredient or combination product); therapeutic class identifier; National Drug Code (NDC) or other drug code (specify coding system used); route of administration; dosage form; strength; molecular salt (if applicable); package details (e.g., form, strength, size or volume); product age (e.g., date first marketed); and—patent details (e.g., date first patent granted, date of patent expiry.

The pricing-specific data elements shall include for all prescription, brand, generic and OTC drugs and biologic products: exit manufacturer price (price paid by wholesaler or pharmacy to the manufacturer); wholesale price (price paid by pharmacy to wholesaler); retail price (price paid by customer to pharmacy); and average retail markup (difference between the retail and wholesale prices). For each data element, the Contractor shall provide descriptive statistics along with the method of computation.

The Contractor shall provide the following information relating to any projection methodologies used to transform raw totals into final data: distribution of types of facilities and sales channels (to include numbers and percents) compared to the national coverage by regions (Northeast, Midwest, South, West); and distribution of sales data characteristics by geography (e.g., urban, rural, etc.), sales volume, type (independent, chain, etc.), and four census regions (see Appendix B).

3.3.2 Technical Requirements and Capabilities

U.S. Pharmaceutical Market-Retail/Non-Retail Data (Unlimited Access License) 80 Users:

Characteristics of the Data Resource(s)

A. The national-level pharmaceutical sales data shall be a currently existing, commercially available product that shall provide immediate access with the capability of providing characterization of current product- and substance-specific drug and biologic sales data to health care settings and facilities.

B. The data shall have the capability of providing both current and historical national-level pharmaceutical sales data.

C. The Contractor shall have the ability to provide national estimates of pharmaceutical sales data using projection or other appropriate methodologies, which shall be valid, reliable, and robust with a full disclosure of data collection procedures required. The Contractor shall notify the FDA and provide documentation of any changes or updates to the projection or other appropriate methodologies.

D. In the event of changes to the Contractor’s business contracts or agreements with their data suppliers, FDA shall be notified within 5 business days of the Contractor becoming aware of such changes. This notification shall include details of the impact of these changes on data quality, data quantity, and overall data characteristics.

Access to the Data Resource(s)

1. Access to the data shall be immediate, unlimited, direct, desktop and in real-time. Access shall include all upgrades, enhancements, and modifications to software and data.

2. The data resource(s) shall be accessible via secure Internet or network-based methods permitting simultaneous, multi-user access through user-friendly data query tool(s). The network-based methods shall not necessitate any additions to the FDA communications infrastructure. Preferred methods for access (in order of preference) are: 1) secure Internet access, and 2) firewall-to-firewall virtual private network (VPN). FDA shall not support modem-based or dial-up access.

3. The Contractor shall provide email notification of any data adjustments and corrections; notify FDA about any circumstances resulting in loss of or lack of access to data from the database;

notify FDA a minimum of 48 hours in advance of planned downtime of the database; notify FDA within 30 minutes from the onset of unplanned downtime within normal hours (Monday-Friday, 8:00 AM – 6:30 PM Eastern Time) with an estimate of time to restoration of access to the database.

4. The Contractor shall maintain continuous access to current national-level pharmaceutical sales data resource(s).

5. In the event of changes to the Contractor’s business contracts or agreements with their data suppliers, FDA shall be notified within 5 business days of the Contractor becoming aware of such changes. This notification shall include details of the impact of these changes on data quality, data quantity, and overall data characteristics.

6. FDA shall not support or maintain Offeror’s equipment or personnel onsite at government facilities.

7. Access shall be through an interface. Minimally, the interface shall provide both predefined (e.g., canned) and custom reports.

8. The Contractor shall provide the FDA with the ability to download (or obtain in a timely manner using other means) large amounts of data (i.e., for many drugs and time periods at once). These data shall be available in machine-readable formats as described in Section 5.3. FDA’s preference is that unrestricted access to datasets shall be available on demand and without intervention by the Contractor through its interface.

Disclosure Clearance And Third Party Agreement, Acceptable Projection Or Other Appropriate Methodology, Current And Complete Data Dictionary, And Technical Support (Inclusive Of Notification Of Access To Upgrades And/Or New Releases Of The Data And Software):

External Disclosure(s)

9. As part of its regulatory activities, FDA shall at times require disclosure of scientific and technical articles, study results, presentations, public health advisories, and similar works involving aggregated data to entities outside the Agency, including the general public. For activities that require disclosure of aggregated data, the Contractor shall accept and adhere to the FDA 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.

10. As part of its regulatory activities, FDA shall at times engage in collaborative research projects with third parties outside of FDA for specific research projects of public health importance that are initiated and conducted 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 to be 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.

11. The FDA shall continue to require, after the conclusion of the contract, the ability to release aggregated data through the FDA Data Disclosure Clearance process for data obtained during the contract period. After Option Year 4, the FDA will notify the Contractor of the aggregated data release and accept the Contractor’s requested revisions, but shall not require formal approval for release.

User Support

12. The Contractor shall provide ongoing technical, analytical, and clinical support by phone or by email, which shall be available for all certified users of the data during business hours (8:00 a.m. - 6:30 p.m. EST), Monday through Friday excluding federal holidays throughout the length of the contract in accordance with the service levels established in the contract.

On-Site Training Programs and Training Materials:

13. The Contractor shall provide a kick-off meeting within 30 days upon award of contract, and two on-site training sessions per option year offered at FDA facilities (Silver Spring, MD). Live or web-based training of FDA staff shall be required for any modifications, enhancements, or upgrades to the data resource. Written documentation related to using the data, such as a User's Manual, shall be required upon award of the contract, and shall be updated upon any subsequent enhancements or upgrades. Training for users of the data, as well as training for FDA personnel who will support use of the data (e.g., technical users) shall also be required. Options for additional “on-demand” sessions via live meeting/web-based methods shall be provided. The training shall be initiated 30 days after receipt of award and continues throughout the duration of contract and the FDA shall provide conference rooms’ onsite at FDA’s location (current location is Silver Spring, MD).

Annual Meeting:

14. The Contractor shall be required to provide an annual meeting for the purposes of discussing FDA satisfaction with all deliverables and any updates or changes to the data resource(s).

Monthly Usage Report:

15. The Contractor shall provide monthly usage reports detailing use of the resource by individual FDA users and type of use.

Ad-Hoc Analyses: Custom Reporting and Product Customization

16. The Contractor shall provide additional ad hoc data analyses or custom queries or product customization not available through the data tools, for example confidence intervals around point estimates, and raw (unprotected) data. The number of hours allocated in the base award will not exceed 50 hours per year.

Other Requirements:

17. Full conformance or level of conformance with Section 508 standards is required (See Appendices C & D).

18. The Contractor shall participate in the CDER secure electronic mail system to protect any sensitive data which may be transmitted electronically between the data vendor and the FDA (Appendix H)

3.4 Indefinite Delivery, Indefinite Quantity (IDIQ) Services

The Contractor shall provide additional quantities of services such as customized analysis or additional training via the issuance of firm fixed-price delivery orders at the labor category rates negotiated for each order within the description of work on an as needed basis. The performance period/delivery date(s) for services ordered shall be specified on each Delivery Order.

The type of additional services and associated maintenance shall include:

• Customized analysis – Analysis of National Pharmaceutical Sales Data that endeavors to answer a specific question that requires additional tools beyond the current interface tool (e.g., includes fields not provided in the tool but that are available in the database).

• International Pharmaceutical Sales Data - Provide FDA personnel with currently existing, commercially available international pharmaceutical sales data to forecast trends in pharmaceutical sales, pricing and volume of distribution throughout various settings of care.

• International Pharmaceutical Pricing Data –Provide data that shall be expressed in units of both Local/Domestic Currency and in US Dollars as well as include relevant period exchange rates to facilitate currency conversion.

• Global Sales Data: Provide FDA personnel with knowledge about pharmaceutical companies, their product portfolios, their R&D pipelines, and countries in which they operate and their sales.

• Training services – Additional ad hoc training services as needed

• Ad Hoc Analyses – The Contractor shall provide additional hours of ad hoc analyses or custom queries not available through the data tool. For example, confidence intervals around point estimates, and raw (unprojected) data.

3.4.1 Labor Category Descriptions

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

• Project manager shall have a minimum of a master’s degree or an equivalent certification and at least 5 years of experience managing projects.

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.

• The individual shall have the required certification with a minimum of 8 years of experience in the field.

Application 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

• Application programmer shall have the required certification with a minimum of 5 years of experience in the field

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

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

• Pharmacist shall be a registered in any state with a minimum of 10 years of experience in the field.

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

• Training Specialist Senior shall have a minimum of eight (8) years of experience in the field or in a related area.

• Educational requirement is a Bachelor's degree in a related area or equivalent.

3.5 FDA Technical Environment

Internet Access

The FDA has direct, desktop access to the Internet.

The system shall be web-based and compatible with commonly used web browsers including Internet Explorer 11 and above, Firefox 23 and above, Chrome, and Safari 4 or higher.

The Contractor’s proposal shall specify any additional software and/or hardware (name and version) necessary to access the data.

Number of Users The FDA shall purchase a site license that shall accommodate 80 users with option(s) for up to 20 additional users within the Office of Surveillance and Epidemiology as well as other authorized users within the FDA will need to access these data as appropriate for their work.

Data Downloading The FDA uses standard statistical and data management software, such as SAS®, STATA®, R, Access® and Excel®, and shall require the ability to download data in formats that are compatible with these packages. The FDA shall also require the ability to download data in ASCII format.

Local Area Network Configuration

The FDA uses a central-server network model. The configuration is a wide area network with transmission control protocol/Internet protocol (TCP/IP) running on a 10/1000 Mbps network.

The FDA will not provide a diagram of the network. FDA will not support dial-in or modem-based access.

Security Any client 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 dataset and requests (e.g SQL queries or similar methods) for accessing the Offeror’s application data sets. This client software shall also not transmit any data to the FDA system other than that needed for developing, transmitting, and reviewing the output of requests (such as documentation and a querying interface).

Virtual Private Network (VPN) The FDA utilizes a virtual private network to establish a trusted, encrypted TCP/IP tunnel for accessing data from a remote location. A VPN shall be a firewall-to-firewall encrypted tunnel utilizing commercially available software and industry standard IPSEC protocols.

PART 4- INSPECTION AND ACCEPTANCE

The Contracting Officer’s Representative (COR) will perform inspection and acceptance of materials, documents and services to be provided.

For the purpose of this PART, COR- [TBD, upon contract award] is the authorized representative of the Contracting Officer.

PART 5- DELIVERABLES AND PERFORMANCE

Deliverables shall be established with the issuance of each task order. All deliverables shall be delivered F.O.B Destination to the COR for acceptance.

52.247-34 FOB Destination (NOV 1991)

5.1 Deliverables

BASE YEAR

Description of Supplies/Service Qty Unit Delivery Date U.S. Pharmaceutical Market - Retail/Non-Retail Data (Unlimited Access License)

One (1) License

Twelve (12) Months

Upon Award of Contract

Disclosure Clearance and Third Party Agreement 1 Unlimited Length of Contract Acceptable Projection or Other Appropriate Methodology

1 Lot Within 30 days of award

Current and complete Data Dictionary 1 Lot Within 30 days of award

On-site training programs and training materials 2 Lot Within 30 days of award

Annual Meeting 1 Lot Annually Technical Support; to include Notification of and Access to Upgrades and/or New Releases of the Data and Software

Unlimited

12 months

Length of Contract

Monthly Usage Reports 12 Lot Monthly Ad-hoc Analyses: custom reporting and product customization

50 Hours As needed

Optional Quantity: Ten (10) Additional Users One (1) License

Twelve (12) Months

Upon Exercise of Option

OPTION YEAR #1

U.S. Pharmaceutical Market - Retail/Non-Retail Data

Unlimited 12 months Length of Contract

Disclosure Clearance and Third Party Agreement 1 Unlimited Length of Contract Current and complete Data Dictionary 1 Lot Annually On-site training programs and training materials 2 Lot Length of Contract Technical Support; to include Notification of and

Annual Meeting 1 Lot Annually Monthly Usage Reports 12 Lot Monthly Ad-hoc Analyses: custom reporting and product customization

50 hours As needed

Optional Quantity: Ten (10) Additional Users One (1) License

Twelve (12) Months

OPTION YEAR #2

U.S. Pharmaceutical Market - Retail/Non-Retail Unlimited 12 months Length of Contract

Data Disclosure Clearance and Third Party Agreement 1 Unlimited Length of Contract Current and complete Data Dictionary, including updates

1 Lot Annually

On-site training programs and training materials 2 Lot Length of Contract Technical Support; to include Notification of and

Monthly Usage Reports 12 Lot Monthly Ad-hoc Analyses: custom reporting and product customization

50 Hours As needed

Optional Quantity: Ten (10) Additional Users One (1) License

Twelve (12) Months

OPTION YEAR #3

U.S. Pharmaceutical Market - Retail/Non-Retail Data

Unlimited 12 months Length of Contract

Disclosure Clearance and Third Party Agreement 1 Unlimited Length of Contract Current and complete Data Dictionary, including updates

1 Lot Annually

On-site training programs and training materials 2 Lot Length of Contract Technical Support; to include Notification of and

Monthly Usage Reports 12 Lot Monthly Ad-hoc Analyses: custom reporting and product customization

50 Hours As needed

Optional Quantity: Ten (10) Additional Users One (1) License

Twelve (12) Months

OPTION YEAR #4

U.S. Pharmaceutical Market - Retail/Non-Retail Data

Unlimited 12 months Length of Contract

Disclosure Clearance and Third Party Agreement 1 Unlimited Length of Contract Current and complete Data Dictionary 1 Lot Annually On-site training programs and training materials 2 Lot Length of Contract Technical Support; to include Notification of and

Monthly Usage Reports 12 Lot Monthly Ad-hoc Analyses: custom reporting and product customization

50 Hours As needed

Optional Quantity: Ten (10) Additional Users One (1) License

Twelve (12) Months

5.2 Delivery Instructions

All deliverables under this contract shall be sent electronically to the COR [TBD] via e-mail.

5.3 Period of Performance

The period of performance for this contract vehicle shall be the effective date of contract for a base year of twelve (12) months, and four (4) option years for a total of five years.

Base Period: First Year After Receipt of Order (ARO).

Option Period 1: Second Year ARO.

Option Period 2: Third Year ARO.

Option Period 3: Fourth Year ARO Option Period 4: Fifth Year ARO.

In addition, the period of performance for the optional quantities for additional users under CLIN’s 0007,0008, 1007, 1008, 2007, 2008, 3007, 3008, 4007 and 4008, if exercised shall only be in effect for the number of months remaining under the current period of performance. For example, if one of these optional quantities is exercised three months into the period of performance, only nine months will be utilized under this CLIN. Should the Government require the additional users in future periods, each optional quantity for that period will be exercised independently.

5.4 Quality Assurance Surveillance Plan:

The contractor shall adhere to the Government’s Quality Assurance Surveillance Plan (QASP) detailed below. 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 Contract Specialist/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.

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 requests; and 72 hours for third-party agreements

Standard shall be fully met at 100%

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

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

Standard shall be fully met at 100%

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

Required Service Standard Acceptable

Quality Level

(AQL)

Method of Surveillance

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

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

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

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

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

5.5 Monthly Reports

Contractor shall provide a Monthly Report, to be submitted no later than the second Monday of every month, to 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 date submitted, project title, purpose (publication, presentation, research or other), FDA requestor and approval date

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

The Monthly report shall be submitted via e-mail to the COR, [TBD] and Contract Specialist, Christopher R. McGucken at Christopher.McGucken@fda.hhs.gov

PART 6- CONTRACT ADMINISTRATION DATA

6.1 Ordering Processes and Procedures

Ordering services under this contract shall be accomplished by the issuance of written task orders specifying the types of services being ordered. All task orders issued under this contract shall conform to the provisions of the contract clause in Part 7 entitled “Ordering.” The only office authorized to process task orders through the Office of Acquisitions & Grants Services is the Food and Drug Administration (FDA) Contracting Officer.

6.2 Task Order Procedures

The process for awarding tasks orders will be as follows:

1. FDA’s Office of Acquisitions & Grants Services Contracting Officer will issue an RTOP (Request for Task Order Proposal) via email. The RFTOP will include at a minimum a SOW, the period of performance, the anticipated order type (FFP, LH, etc.), reporting requirements and deliverables, and any special terms and conditions applicable to the Task Order.

2. The Contractor shall prepare and submit a task proposal addressing all areas of the requirement.

The Contractor shall submit the task proposal within the time period specified in the RFTOP and adhere to the ceiling rates established in the contract. No separate payment will be made to the contractor for the cost to prepare, submit and/or negotiate a task order proposal.

3. Within ten (10) business days (unless another time frame is specified in writing), the contractor will provide a proposal to the Contracting Officer. The proposal will include a brief description of the technical approach and a price build up. The price build up should include the labor categories to be utilized, the number of hours within each labor category, extended pricing for each labor category and a bottom line price/ceiling.

4. FDA will evaluate the task order proposal for technical acceptability and price reasonableness.

FDA will consider the following technical factors: technical approach, whether the labor mix is appropriate; and whether the level of effort is sufficient. If the FDA has questions or concerns the Contracting Officer will contact the contractor, and may ask for a revised proposal.

5. Once the proposal is acceptable, the Contracting Office will issue the task order.

6. Orders will include the following:

a. Task Order Number

b. Date

c. Accounting Information

d. Statement of Work (SOW)

e. Price/Ceiling

f. Period of Performance

g. Any terms, conditions, or instructions unique to the order.

Any work that the Contractor undertakes prior to receiving a fully executed task order signed by the

Contracting Officer is undertaken at risk.

6.3 Contracting Officer Representative

The following COR will represent the Government for the purpose of this contract:

(COR To be determined at the time of contract award)

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending changes in requirements to the Contracting Officer; (2) interpreting the Statement of Work and any and all other technical performance requirements; (3) performing technical evaluations as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance of the contract. The Government may unilaterally change its COR designation.

6.4 The contact information for the Contracting Specialist is:

Christopher R. McGucken

OFBA/OO/OAGS

5630 Fishers Lane Rockville, MD 20857 E-Mail: Christopher.McGucken@fda.hhs.gov Phone: (240) 402-7566

6.5 The contact information for the Contracting Officer is:

Ronald R. Rouse

OFBA/OO/OAGS

5630 Fishers Lane Rockville, MD 20857 Phone: (240) 402-7615 Email: Ronald.Rouse@fda.hhs.gov

6.6 Key Personnel

The Contractor shall provide the names and qualifications of the key personnel assigned to this contract.

The individuals cited below are key personnel.

Name Title

Project Manager _______________

In the event that any of the personnel listed as key personnel are unable to perform because of health, resignation from the Contractor’s employ, or any other reasons, the Contractor shall promptly submit to the Contract Specialist, a detailed written explanation of the situation, the proposed substitution, complete resumes for the proposed substitute, and any other information necessary for the approval of the substitution. No substitutions shall be made without prior written approval of the Contract Specialist. No increase in contract pricing will be allowed when substitutions are authorized by the government.

6.7 INVOICE SUBMISSION

FDA THREE-WAY-MATCHING INVOICE CLAUSE

A. THE CONTRACTOR SHALL SUBMIT ONE (1) ORIGINAL COPY OF EACH INVOICE TO

THE ADDRESS SPECIFIED BELOW:

Office of Financial Services Food and Drug Administration 10903 New Hampshire Ave WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002 mailto:Tara.Hobson@fda.hhs.gov mailto:Ronald.Rouse@fda.hhs.gov

Attn: Vendor Payments

301.827.3742 or 866.807.3742 fdavendorpaymentsteam@fda.gov

B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses

52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer / System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(i) Name and address of the contractor;

(ii) Invoice date and invoice number;

(iii) Purchase order/award number;

(iv) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including:

(a) period of performance for which costs are claimed;

(b) itemized travel costs, including origin and destination;

(c) any other supporting information necessary to clarify questionable expenditures;

(d) The contractor shall include the Contract Line Item/Funding line item number for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment);

(viii) Name, title, and phone number of person to notify in event of defective invoice;

(ix) Taxpayer identification number (TIN);

(x) Electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment

(xi) Name and telephone number of the FDA Contracting Officer (CO) and the Contracting Officer's

Representative (COR) or other program center/office point of contact, as referenced on the order/contract;

(xii) Any other information or documentation required by the purchase order/award.

C. An electronic invoice shall be in adobe acrobat (PDF) format. All items listed in (i) through (xii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D. Questions regarding invoice payments should be directed to the FDA Payment Office at:

Food and Drug Administration/ Office of Financial Services, 10903 New Hampshire Ave WO32 - Second Floor, MAIL HUB 2145 Silver Spring, MD 20993-0002 Attn: Vendor Payments Phone 301-827-ERIC (3742)

SECTION 7- SPECIAL CONTRACT REQUIREMENTS

7.1 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.

Offerors submitting proposals to perform work under this contract must assure the protection of the information and data they receive under this contract from unauthorized use or disclosure, and must treat the information as confidential or otherwise privileged.

PART 8- CONTRACT CLAUSES

8.1 FAR CLAUSES:

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR

EXECUTIVE ORDERS--COMMERCIAL ITEMS (JAN 2017)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19,Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

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

(4) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004)(Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

__X __ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sep 2006), with Alternate I (Oct 1995)(41 U.S.C. 4704 and 10 U.S.C. 2402).

__ __ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509).

__ __ (3) 52.203-15, Whistleblower Protections Under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub. L. 111-5).

(Applies to contracts funded by the American Recovery and

Reinvestment Act of 2009.)

__X __ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract

Awards (Oct 2016) (Pub. L. 109-282) (31 U.S.C. 6101 note).

(5) [Reserved] __ __ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-

117, section 743 of Div. C).

__ __ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery

Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

__X __ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with

Contractors Debarred, Suspended, or Proposed for Debarment (Oct 2015) (31 U.S.C. 6101 note).

__X __ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313).

____ (10) [Reserved} __ __ (11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov

2011)(15 U.S.C. 657a).

__ __ (11) (ii) Alternate I (Nov 2011) of 52.219-3.

__X __ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small

Business Concerns (Oct 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C. 657a).

__ _…