FDA-RFP-18-1185455.pdf

FDA-RFP-18-1185455

ACCESS TO HEALTH CARE PRACTITIONER PRESCRIBING DATA

PART 1- Description

Solicitation number FDA-RFP-18-1185455 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 contract and resultant task orders will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-96. 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 Contract, with a Labor Hour and Indefinite Delivery/Indefinite Quantity (IDIQ) portion 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 contract maximum ceiling amount for the IDIQ portion will be $500,000.00 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 Healthcare Practitioner Prescribing Practices Data.

2.2 Pricing Schedule Firm Fixed-Price (Sections 3.1 -3.6)

BASE YEAR

CLIN Description of Supplies/Service Qty. Unit Total Price

0001 Access to Healthcare Practitioner Prescribing Practices Data (Unlimited Access License) 50 Users

12 Month

Kick Off/On-site Annual Meeting 1 Lot

0003 Disclosure Clearance Service/Third Party Agreement Services.

0004 Acceptable Projection or Other Appropriate Methodology 1 Lot

0005 Current and complete Data Dictionary, including updates 1 Lot

0006 On-site training programs and training materials 2 Lot

0007 Technical Support; to include Notification of and Access to Upgrades and/or New Releases of the Data and Software

0008 Monthly Usage Reports 12 Month 0009 Ad hoc Analyses: custom reporting and product customization.

50 Hour

0010 Optional Quantity: Ten (10) Additional Users. 12 Month

0011 Optional Quantity: Ten (10) Additional Users. 12 Month

Base Year Total Firm Fixed Price

OPTION YEAR 1

CLIN Description of Supplies/Service Qty. Unit Total Price

1001 Access to Healthcare Practitioner Prescribing Practices Data (Unlimited

1003 Disclosure Clearance Service/Third Party Agreement

1004 Acceptable Projection or Other

1005 Current and complete Data Dictionary, including updates 1 Lot

1006 On-site training programs and training materials 2 Lot

1007 Technical Support; to include Notification of and Access to

1008 Monthly Usage Reports 12 Month 1009 Ad hoc Analyses: Custom reporting and product

0010 Optional Quantity: Ten (10)

0011 Optional Quantity: Ten (10) Additional Users. 12 Month

Option Year 1: Total Firm Fixed Price

OPTION YEAR 2

CLIN Description of Supplies/Service Qty. Unit Total Price

2001 Access to Healthcare Practitioner Prescribing Practices Data (Unlimited

2003 Disclosure Clearance Service/Third Party Agreement

2004 Acceptable Projection or Other

2005 Current and complete Data Dictionary, including updates 1 Lot

2006 On-site training programs and training materials 2 Lot

2007 Technical Support; to include Notification of and Access to

2008 Monthly Usage Reports 12 Month 2009 Ad hoc Analyses: Custom reporting and product

2010 Optional Quantity: Ten (10)

2011 Optional Quantity: Ten (10)

Option Year 2: Total Firm Fixed Price

OPTION YEAR 3

CLIN Description of Supplies/Service Qty. Unit Total Price

3001 Access to Healthcare Practitioner Prescribing Practices Data (Unlimited

3003 Disclosure Clearance Service/Third Party Agreement

3004 Acceptable Projection or Other

3005 Current and complete Data Dictionary, including updates 1 Lot

3006 On-site training programs and training materials 2 Lot

3007 Technical Support; to include Notification of and Access to

3008 Monthly Usage Reports 12 Month 3009 Ad hoc Analyses: Custom reporting and product

3010 Optional Quantity: Ten (10)

3011 Optional Quantity: Ten (10) Additional Users. 12 Month

Option Year 3: Total Firm Fixed Price

OPTION YEAR 4

CLIN Description of Supplies/Service Qty. Unit Total Price

4001 Access to Healthcare Practitioner Prescribing Practices Data (Unlimited

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

4003 Disclosure Clearance Service/Third Party Agreement

4004 Acceptable Projection or Other

4005 Current and complete Data Dictionary, including updates 1 Lot

4006 On-site training programs and training materials 2 Lot

4007 Technical Support; to include Notification of and Access to

4008 Monthly Usage Reports 12 Month 4009 Ad hoc Analyses: Custom reporting and product

4010 Optional Quantity: Ten (10)

4011 Optional Quantity: Ten (10)

Option Year 4: Total Firm Fixed Price

IDIQ Labor Rate Pricing Chart: (Section 3.7)

Hourly Rate

Labor Category Estimated # of Hours Per

Year Base Year Option

Year 1 Option Year 2

Option Year 3

Option Year 4

Total Rate(s) x Hours

Project Manager 1040

Senior Computer Analyst 1040

Application Programmer 1040

Statistician 1040

Pharmacist 1040

Senior Training Specialist 1040

Computer Programmer 1040 Total IDIQ Portion Pricing* $

*Please note that the total pricing/estimated hours requested under this RFP is for evaluation purposes only.

Number of hours required will be specified on a task task order basis.

PART 3- DESCRIPTIONS/SPECIFICATIONS/STATEMENT OF WORK

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

3.1 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 for 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.

In response to reports from the Institute of Medicine (IOM), FDA is authorized by the FDA Amendments (2007) Act to expand database resources for providing advanced analyses of drug safety data to improve the quality of post-market risk/benefit analyses, and enhance the ability of FDA to make timely assessments of drug safety data. In addition, a sub-section of the Act calls for enhanced authorities for accessing disparate data sources, establish and improve procedures to identify data trends and prescribing patterns for health care practitioners on a national level in the outpatient setting.

https://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf https://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf

The 21st Century Cures Act which was enacted in December 2016 also contains provisions for the FDA to increase surveillance and monitoring of certain medications such as opioids which aligns with CDER’s mission. This section of the Act encourages the use of real world evidence in the analysis of post market surveillance data to enable the Agency to respond promptly to serious public health issues.

https://www.congress.gov/114/bills/hr34/BILLS-114hr34enr.pdf

The ability of FDA to respond expeditiously to the increasing number of drug safety issues is crucial to the overall public safety. Continued access to healthcare practitioner prescribing practices data (e.g. physician survey) will complement and strengthen the utility of FDA's Adverse Event Reporting System (FAERS) currently in place. Access to these data also increases the FDA’s ability to perform regulatory impact studies; in particular, those studies that assess the effectiveness of product labeling in influencing prescribing behavior. 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 Data on Prescribing Practices of Health Care Practitioners" would serve as a mechanism for FDA to respond expeditiously to serious public health or regulatory issues.

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 outlined in section 301 of the Public Health Service Act

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

3.2 Program Research Goals and Objectives:

A. The Contractor shall provide FDA personnel with access to a currently existing, commercially available data resource on health care practitioner prescribing practices including but not limited to patient demographics, and indications for treatment in the outpatient setting using surveys.

B. This data source shall have the ability of providing national estimates of health care practitioner prescribing patterns in the outpatient setting through the use of projection or other appropriate methodologies based on a nationally representative sample that are scientifically sound and transparent to FDA personnel.

C. The Contractor shall provide FDA personnel with data that has a maximum of 3-month lag time, i.e., time between the date of prescriber/patient encounter and date of data availability for FDA use.

D. The Contractor shall provide FDA personnel with immediate, direct, unlimited, internet or network-based access to all HIPAA-compliant data in a multi-user, desktop environment and in real time.

3.3 Scope of Work

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

https://www.congress.gov/114/bills/hr34/BILLS-114hr34enr.pdf

3.4 Access to Healthcare Practitioner Prescribing Practices Data;

The Contractor shall provide continuous access to data resources on health care practitioner prescribing practices for fifty (50) users including, but not limited to drug treatment patterns, patient demographics, and indications for treatment in the outpatient setting. The source data can be obtained from a survey of healthcare practitioner prescribing practices.

FDA requires access to such data to obtain national estimates or counts. The FDA has no interest in knowing the identity of any patient, provider, or health plan included in the data.

It shall be solely the Contractor’s responsibility to de-identify the data for FDA use.

For survey data, the Contractor shall project the data to the national level using an FDA approved projection or other appropriate methodology. Results from projections shall be comparable to estimates obtained from national benchmarks such as the National Center for Health Statistics’ National Ambulatory Medical Care Survey (NAMCS). The data resource(s) shall have raw and projected numbers.

These data resources shall be accessible via a secure Internet or network-based method permitting simultaneous, multi-user access through a user-friendly data query tool(s).

The health care practitioners (e.g., physicians, physician assistants, nurse practitioners, dentists) prescribing practices data shall include visits and patients; characterization of individual health care practitioners in terms of number, specialty, practice setting, age, gender, and U.S. Census region. Additionally, these data shall provide health care practitioner prescribing practices data in terms of type of facility (e.g., surgi-centers, staff model HMOs, clinics), and U.S. Census region and where possible, the contractor shall provide a comparison to national figures.

The patient-specific population data shall include the number and percent of patient populations of special interest to the FDA, including children (≤ 17 years), infants (<1 year), women of childbearing age, and elderly (≥ 65 years); the health care practitioner turnover rate for participation in the data resource; and the demographic distribution of patients (age and gender are required; race, if available).

The patient-specific basic data elements at the visit-level shall include (but are not limited to): patient demographics 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 which would include race/ethnicity; height and weight; clinical measures, such as blood pressure, cholesterol, smoking status; type of insurance; and U.S Census region.

The drug-specific basic data elements shall include generic/trade name of drug; linkage between generic and established name; strength; dosage form; new vs. continued therapy;

days’ supply; prescriber specialty; quantity prescribed; directions for use; indication(s) for use, concurrent or concomitant drug or diagnosis, and source of drug (sample provided, prescription given, product administered).

The diagnosis-specific basic data element shall describe the patient’s condition as identified by the health care practitioner during the time of office-visit; as well as visit-specific basic data elements with the time of visit (month, year); the type of visit, e.g., first vs. subsequent visit; and the type of outpatient setting and the health care practitioner-specific basic data elements shall include the type of practitioner; specialty; age; gender; and U.S Census region.

The data resource shall include a drug coding system that consists of drug, clinical, or medical coding levels for FDA data analyses, quantify the prescribing of drug or biologic products in the outpatient setting by healthcare professionals. For examining visit-level prescribing data for products, the data resource shall link clinical or medical data to indication in detail. For examining data on visits for specified disease or medical conditions, and associated treatments (if any), the data resource shall capture the drugs prescribed to treat the same diagnosis as well as all drugs mentioned during the visit regardless of diagnosis.

The contractor shall notify FDA within five (5) business days of any changes in their underlying data (e.g. data suppliers) that affect the data quantity and overall data characteristics.

The Contractor shall conform to Section 508 standards (See Appendices C and D).

The Contractor shall conduct and participate in a kick-off meeting within two weeks of award on-site at the FDA campus in Silver Spring, MD. 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.

To protect any sensitive data which may be transmitted electronically between the data vendor and the FDA, the data vendor shall participate in the CDER secure electronic mail system (see Appendix G).

3.6 Technical Requirements and Capabilities

The Contractor shall provide patient-level and/or visit-level data that is current and commercially available. The data shall be provided in a HIPAA-compliant product that shall provide immediate automated access with the capability of providing characterization of health care practitioner prescribing practices including but not limited to patient demographics, and indications for treatment in the outpatient setting; and shall provide immediate automated access with the capability of providing both current and a minimum of six (6) years historical national-level prescribing practice information.

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. Access shall be via secure Internet or network-based methods and shall be in a multi-user environment. 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. Access shall be through an existing interface and this interface shall be user-friendly, transparent (e.g. clarity of details, limitations and assumptions), and flexible enough to meet the FDA’s needs. Minimally, the interface shall provide both predefined (e.g., canned) and custom reports.

FDA requires the ability to make national estimates of visit-based and/or patient-based outpatient health care practitioner prescribing practices using projection or other appropriate methodologies, which shall be valid, reliable, and robust regarding prescribing practices specifically, and the methods fully disclosed.

The FDA shall have the ability to archive and analyze historical data in a timely manner.

The FDA shall have the ability to download (or obtain in a timely manner using other means) and analyze patient-level data. FDA’s preference is that unrestricted access to datasets shall be available on demand and without intervention by the Contractor.

All data shall be HIPAA-compliant. No patient, practitioner, or health plan-specific identifiers will be required by FDA. It shall be solely the Contractor’s responsibility to de-identify the data for FDA use.

3.6.1 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 training sessions per year. The Contractor shall provide course outlines for all levels of training offered on site at FDA (Silver Spring, MD) and options for additional “on-demand” sessions via web-based methods. The training shall be initiated within 30 days of award and continue throughout the duration of contract. The Contractor shall provide a support package comprised of written documentation that includes technical, analytical, and clinical support throughout the length of the contract.

3.6.2 Technical Support

Ongoing technical, analytical, and clinical support by phone or by e-mail shall be required for all certified users of the data during business hours (8:30am-6:00pm EST) excluding federal holidays throughout the length of the contract in accordance with the service levels established in the Performance Requirements Summary Table (PRST) in the contract.

3.6.3 Monthly Usage Reports

The Contractor shall provide Monthly Usage Reports detailing use of the resource by individual FDA users and type of use (See Appendix H - Example of Monthly Usage Report).

3.6.4 Disclosure Clearance Services

3.6.4.1 Disclosure Clearance for Aggregated Data outside the Agency:

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.

The FDA shall continue to require the ability to release aggregated data through the FDA Data Disclosure Clearance process for data obtained during the contract period for the period of Option Year 4 (year 5 of the contract). After Option Year 4, FDA will not require data access service, but will require the services of processing clearance requests. After option year 4, the FDA will notify the contractor of the aggregated data release and accept the Contractor’s requested revisions for a maximum of one year, but will not require formal approval for release.

3.6.4.2 Clearance for Third Party Collaborations:

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 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.

3.6.4.3 Ad Hoc Analyses

The Contractor shall provide additional ad hoc data analyses or custom queries or product customization not available through the data tools and in increments of 50 hours.

3.7 Indefinite Delivery, Indefinite Quantity (IDIQ) Services Associated with the Scope of

Work

The contractor shall provide additional ad hoc data analyses or custom queries or product customization not available through the data tools not to exceed 100 man-hours per year.

The Contractor shall provide additional quantities of Services via the issuance of firm fixed price or time and materials delivery orders at the unit price negotiated for each order within the description of work. The performance period/delivery date(s) for services ordered shall be specified on each Order. The combined price of all orders shall not exceed $500,000.00 over the total period of performance (base and option periods).

The type of additional services and associated maintenance would include:

• Validation studies- studies that are conducted to establish soundness or validity of the method used, for example to validate indications for treatment in the database against the survey or claims data.

• Projection methodology studies- Developing methods that will allow projecting the number of mentions or use based on the sample survey for drugs associated with specific diseases, conditions, or indications.

• Concomitant drug reports – Reports on the concomitant use of two or more drugs from the same therapeutic class or different therapeutic classes used to treat the same diagnosis

• 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

• 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

• Customized metrics/questions – Ability to issue a customized query outside of the prespecified drug-specific basic data captured in the tool. For example, if pre-specified surveys are used to in data collection, the ability to add a defined custom question to the survey for a limited period of time.

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

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

3.7.1 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

(for example, a PMP) and/or 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 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 in the form of desired results.

• Designs, codes, tests, debugs, and documents.

• Application programmer shall have 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 healthcare practitioners and provide information to patients on use of medications. May advise physicians and other healthcare practitioners on the selection, dosage, interactions, and side effects of medications.

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

• The pharmacist shall have professional liability insurance.

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.

• The senior training specialist shall have a minimum of five (5) years of experience.

4 Contracts Management Requirements

Performance Evaluation Plan:

Throughout performance the contractor shall be evaluated to determine whether it meets the threshold of the performance requirements summary table (PRST), below. 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. The Government reserves the right to alter or change the surveillance methods at its own discretion.

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 requests;

and 72 hours for third-party agreements

Standard shall be fully met at 100%

COR and FDA staff shall maintain a monthly 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

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

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 for 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 via e-mail to the COR.

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)

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 Table Description of Supplies/Service Qty Unit Delivery Date

Healthcare Practitioner Prescribing Practices Data

(Unlimited Access License) 50 Users

One (1) License Twelve

(12) Months

Upon Award of Contract/Exercise of Option Year

Kick Off/On-site Annual Meeting 1 Lot Within thirty (30) days of Contract

Award/Exercise of Option Year Disclosure Clearance

Service/Third Party Agreement Services

1 Unlimited Length of contract

Acceptable Projection or Other Appropriate Methodology 1 Lot Within 30 days of award

Current and complete Data Dictionary, including updates 1 Lot At time of award and annually

IDIQ 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)

PART 6- FDA TECHNICAL ENVIRONMENT

6.1 Internet Access

The FDA has direct, desktop access to the Internet. The FDA standard browser package is Microsoft Internet Explorer Version 11.x and Firefox 24.x. The Contractor shall specify any additional software and/or hardware (name and version) necessary to access the data

6.2 Number of Users

The FDA shall purchase one site license for 50 certified users with two (2) options for up to 10 additional users each.

6.3 Data Downloading

The Contractor shall provide the FDA the ability to 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.

6.4 Local Area Network Configuration

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.

6.5 Security

On-site training programs and training materials 2 Lot

Initiated within 30 days of award and continues through length of contract Technical Support; to include Notification of and Access to

Unlimited

12 months Length of contract

Monthly Usage Reports 12 Lot Monthly (by the 30th of each month) Ad hoc Analyses: custom reporting and product

50 Hours Lot As needed

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

6.6 Virtual Private Network (VPN)

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 VPN 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 & D).

PART 7- PERIOD OF PERFORMANCE

The effective date of contract through twelve (12) months and four one-year options, as follows:

Base Year: March 16, 2018 – March 15, 2019 Option Year #1: March 16, 2019 – March 15, 2020 Option Year #2: March 16, 2020 – March 15, 2021 Option Year #3: March 16, 2021 – March 15, 2022 Option Year #4: March 16, 2022 – March 15, 2023

PART 8- CONTRACT ADMINISTRATION DATA

8.1 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 8 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.

8.2 Task Order Procedures

The process for awarding tasks orders will be as follows:

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.

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 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.

1. 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 shall include the labor categories to be used, the number of hours within each labor category, extended pricing for each labor category and a bottom line price /ceiling.

2. 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.

3. After the proposal is acceptable, the Contracting Office will issue the task order.

4. 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.

8.3 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.

8.4 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

8.5 The contact information for the Contracting Officer is:

Matthew J. Bucher

OFBA/OO/OAGS

5630 Fishers Lane Rockville, MD 20857 Phone: (240) 402-7570 Email: Matthew.Bucher@fda.hhs.gov

8.6 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 _______________

If 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.

8.7 INVOICE SUBMISSION

FDA THREE-WAY-MATCHING INVOICE CLAUSE

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

mailto:Tara.Hobson@fda.hhs.gov

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 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)

PART 9- SPECIAL CONTRACT REQUIREMENTS

9.1 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 10- CONTRACT CLAUSES

10.1 FAR CLAUSES:

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS--COMMERCIAL ITEMS

(NOV 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).

__ _ (12) (ii) Alternate I (Jan 2011) of 52.219-4.

(13) [Reserved] __ __ (14) (i) 52.219-6, Notice of Total Small Business Set-Aside (Nov

2011)(15 U.S.C. 644).

__ __ (14) (ii) Alternate I (Nov 2011).

__ __ (14) (iii) Alternate II (Nov 2011).

__ __ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June

2003)(15 U.S.C. 644).

__ __ (15) (ii) Alternate I (Oct 1995) of 52.219-7.

__ __ (15) (iii) Alternate II (Mar 2004) of 52.219-7.

__X __ (16) 52.219-8, Utilization of Small Business Concerns (Nov 2016) (15

U.S.C. 637(d)(2) and (3)).

___ __ (17) (i) 52.219-9, Small Business Subcontracting Plan (Jan 2017) (15

U.S.C. 637(d)(4)).

__ __ (17) (ii) Alternate I (Nov 2016) of 52.219-9.

__ __ (17) (iii) Alternate II (Nov 2016) of 52.219-9.

__ __ (17) (iv) Alternate III (Nov 2016) of 52.219-9.

____ (17) (v) Alternate IV (Nov 2016) of 52.219-9.

__ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C.

644(r)).

__ _ (19) 52.219-14, Limitations on Subcontracting (Jan 2017)(15 U.S.C.

637(a)(14)).

_____ (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15

U.S.C. 637(d)(4)(F)(i)).

__ __ (21) 52.219-27, Notice of Total Service-Disabled Veteran-Owned Small

Business Set-Aside (Nov 2011)(15 U.S.C. 657 f).

__X __ (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul

2013) (15 U.S.C. 632(a)(2)).

__ __ (23) 52.219-29, Notice of Set-Aside for, or Sole source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Dec 2015) (1 U.S.C. 637(m)).

__ __ (24) 52.219-30, Notice of Set-Aside for, or Sole source Award to, Women- Owned Small Business Concerns Eligible Under the Women- Owned Small Business Program (Dec 2015) (15 U.S.C.

637(m)).

__X __ (25) 52.222-3, Convict Labor (June 2003)(E.O. 11755).

__ __ (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies

(Oct 2016) (E.O. 13126).

__X __ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

__X __ (28) 52.222-26, Equal Opportunity (Sept 2016)(E.O. 11246).

__X __ (29) 52.222-35, Equal Opportunity for Veterans (Oct 2015)(38 U.S.C.

4212).

__X __ (30) 52.222-36, Equal Opportunity For Workers with Disabilities (Jul

2014)(29 U.S.C. 793).

__X __ (31) 52.222-37, Employment Reports on Veterans (Feb 2016)(38 U.S.C.

4212).

__X __ (32) 52.222-40, Notification of Employee Rights Under the National Labor relations Act (Dec 2010) E.O. 13496).

__X __ (33) (i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627).

__ __ (33) (ii) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

__ __ (34) 52.222-54, Employment Eligibility Verification (Oct 2015). (E. O.

12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

_____ (36) 52.222-60, Paycheck Transparency (Executive Order 13673) (October

2016).

__ __ (37) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008)(42 U.S.C.

6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ _ (37) (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)).

(Not applicable to the acquisition of commercially available off-the-shelf items.)

__ __ (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (June 2016) (E.O. 13693).

__ __ (39) 52.223-12, Maintenance, Service, repair, or Disposal of Refrigeration Equipment and Air Conditioners (June 2016) (E.O.13693).

__ _ (40) (i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514).

__ _ (40) (ii) Alternate I (Oct 2015) of 52.223-13.

__ _ (41) (i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (Jun

2014) (E.O.s 13423 and 13514).

__ _ (41) (ii) Alternate I (Jun 2014) of 52.223-14.

__ __ (42) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec

2007) (42.U.S.C. 8259b).

__ __ (43) (i) 52.223-16, Acquisition of EPEAT®-Registered Personal

Computer Products (Oct 2015) (E.O.s 13423 and 13514).

__ _ (43) (ii) Alternate I (Oct 2015) of 52.223-16.

__X __ (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging

While Driving (Aug 2011) (E.O.13513).

__ __ (45) 52.223-20, Aerosols (Jun 2016) (E.O. 13693) __ __ (46) 52.223-21, Foams (Jun 2016) (E.O. 13693).

__X __ (47) (i) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).

___ (47) (ii) Alternate I, (Jan 2017) of 52.244-3.

__ __ (48) 52.225-1, Buy American--Supplies (May 2014) (41 U.S.C. chapter 83).

__ __ (49) (i) 52.225-3, Buy American--Free Trade Agreements--Israeli Trade

Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112- 43).

__ _ (49) (ii) Alternate I (May 2014) of 52.225-3.

__ _ (49) (iii) Alternate II (May 2014) of 52.225-3.

__ _ (49) (iv) Alternate III (May 2014) of 52.225-3.

__ __ (50) 52.225-5, Trade Agreements (Oct 2016) (19 U.S.C. 2501, et seq., 19

U.S.C. 3301 note).

__X __ (51) 52.225-13, Restriction on Certain Foreign Purchases (Jun

2008)(E.O.s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of Treasury).

__ __ (52) 52.225-26, Contractors…