FDA-17-RFP-1162339_Amendment_2.doc

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FDA-17-RFP-1162339

FDA Support Services: Access to Hospital Inpatient and Emergency Department Drug Utilization Data

RFP Number: FDA-17-RFP-1162339 (Amendment 2) Part 1 – Description 1.1 Solicitation Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6 and 13, streamlined procedures for evaluation and solicitation for commercial items-as supplemented with additional information included in this notice. This announcement constitutes the only full and open competition solicitation; proposals are being requested, and a written solicitation document will not be issued. This solicitation is a Request for Proposal (RFP).

The associated North American Industrial Classification System (NAICS) code for this procurement is 518210. The size standard is $32.5 million.

1.2 Type of Contract

The Government contemplates a single or possibly a multiple award of a hybrid Firm-Fixed-Price, Labor Hour and Indefinite Delivery/Indefinite Quantity (IDIQ) contract vehicle for three years, One (1) Base Year and Two (2) Option Years. There will be The IDIQ portion of the contract intends to issue of Firm-Fixed-Price, Labor Hour Task Orders Task Orders. If a multiple award is made no more than two awards will be issued.

The IDIQ guaranteed minimum amount will be the amount of the awarded fixed price portion of the contract. The contract maximum ceiling amount will be $2,500,000.00 over three (3) years inclusive of options.

Part 2 – Supplies or services and Prices/Costs 2.1 Description of Services and Supplies The FDA has a requirement for Access to Hospital Inpatient and Emergency Department Adult and Pediatric Drug Utilization Data.

2.2 Pricing Schedule

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

Base Year

Data Resource and Services for Pediatric Patients in Short-Stay and/or Free-Standing Pediatric Hospitals for One site license of 20 users

Total

Labor Hours (Ad Hoc) (Fully Burdened Labor Rates)

Optional Line

Data Resource and Services for Pediatric Patients in Short-Stay and/or Free-Standing Pediatric Hospitals for One site license of 10 users

Option Year 1

Data Resource and Services for Pediatric Patients in Short-Stay and/or Free-Standing Pediatric Hospitals for One site license of 20 users

Total

Data Resource and Services for Pediatric Patients in Short-Stay and/or Free-Standing Pediatric Hospitals for One site license of 10 users

Option Year 2

Data Resource and Services for Pediatric Patients in Short-Stay and/or Free-Standing Pediatric Hospitals for One site license of 20 users.

Total

Data Resource and Services for Pediatric Patients in Short-Stay and/or Free-Standing Pediatric Hospitals for One site license of 10 users

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)

Rate X #Hours

Project Manager

Base Year

Senior Computer Analyst Base Year

Application Programmer

Base Year

Statistician

Base year

Pharmacist

Base Year

Senior Training Specialist

Base Year

Note: Hours per year are estimated and used for award evaluation purposes only.

Reference Glossary (Attachment 3 Appendix A) for a full description of each labor category.

2.3 Travel Policy

The Government will reimburse the Contractor for the allowable travel costs incurred by the Contractor in performance of the contractor and determined to be in accordance with FAR Part 15 for two (2) on-site trainings and 1 annual meeting.

Part 3 – Description/Specifications/Work Statement

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 by the American people. The statutory provisions of the Federal Food, Drug, and Cosmetic Act as amended by the Food and Drug Administration Modernization Act (FDAMA, Section 406), Title 21 Code of Federal Regulations, Section 310.305, and Title 21 Code of Federal Regulations, Section 314.80 require FDA to ensure the safety and effectiveness of regulated marketed products.

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 Institute of Medicine 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. The Office of Surveillance and Epidemiology (OSE) contributes to this effort by evaluating drug risks and promoting the safe use of drugs by the American people. 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, establishing and improving procedures to identify drug use data trends on a national level in the inpatient and outpatient emergency department setting.

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 estimates of the numbers of adult and pediatric patients exposed to drugs nationwide in the inpatient and outpatient emergency department setting. These data resources provide a denominator, or context, for understanding adverse event reports; for modeling drug risk based on usage patterns; and for calculating patient-based reporting rates for drugs used in the inpatient and outpatient emergency department setting. Access to these data also increase the FDA’s ability to request regulatory impact studies such as those authorized under Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA) to better understand the usefulness of drug labeling to clinicians. This can be done by examining actual use of products in hospitals in relation to recommended labeling. Finally, direct access to these data in real time enhances and accelerates the pace of FDA's regulatory decision-making process.

The statutory provisions of the Federal Food, Drug, and Cosmetic Act as amended by the Food and Drug Administration Modernization Act (FDAMA, Section 406), Title 21 Code of Federal Regulations, Section 310.305, and Title 21 Code of Federal Regulations, Section 314.80 require FDA to ensure the safety and effectiveness of regulated marketed products. The funding of "Access to Inpatient and Emergency Department Adult and Pediatric Drug Utilization Data" would serve as a mechanism for FDA to respond expeditiously to serious public health, regulatory issues, and legislative mandate. 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 Scope of Work

The services associated with this project shall include:

A. Provide FDA personnel with immediate automated access to currently existing, commercially available data resource for adult and pediatric hospital inpatient and emergency department (ED) data in short-stay hospitals with the capability of providing counts of discharges and patients utilizing drugs and/or treatment procedures;

B. Provide FDA personnel with the ability to use these data to describe national patterns of drug utilization and treatment procedures in the adult and pediatric hospital inpatient and emergency department (ED)settings through the use of projection or other appropriate methodologies that are scientifically sound and transparent to FDA personnel;

C. Provide FDA personnel with direct, unlimited, Internet or network-based access via an interface tool to the entire data resource for adult and pediatric hospital inpatient data and emergency department (ED) data in a multi-user environment and in real time;

D. Provide FDA personnel with the ability to download (or using other means that are compatible large datasets as needed, for the purpose of conducting epidemiological drug safety studies.

3.3 Statement of Work

CLIN 0001: Adult and Pediatric Patients Data

Unlimited Direct Access to Adult and Pediatric Hospital Inpatient and Emergency Department Data Resource

Data Requirements

A. The Contractor shall provide continuous access to data resources on hospital inpatient and emergency department (ED) drug product usage and treatment procedures in adult and pediatric patients throughout the length of the contract. For the purpose of this contract, these data shall meet the need of the FDA to access discharge-level and patient-level data describing adult and pediatric hospital inpatient, ED drug use and treatment procedures in short-stay hospitals;

B. The Contractor shall provide information on the size and characteristics of the population of hospitals from which the data are derived since these can affect the quality and usefulness of the data and the validity of national projections from the data. Characteristics of the sample shall minimally include: number of hospitals; number and proportion of short-stay hospitals, size of hospitals, geographic diversity of hospitals (using census regions if available) (See Appendix B), number of discharges per year, demographic distribution of discharges in the sample, numbers and percentages of discharges per year of special populations of interest to the FDA, including children (ages <17 years), elderly (ages >65 years), pregnancies and deliveries, and patients with serious illnesses including HIV/AIDS and mental illness, types of hospitals, and a description of specialty units within sample hospitals;

C. The Contractor shall provide the number of unique patients hospitalized per year in the sample and their demographic distribution. The FDA has no interest in knowing the identity of any patient, provider, or hospital included in the data resource so the described data provided shall be de-identified;

D. In addition, the following information shall be provided to the FDA: the number of years of valid data available overall and on-line in real time to FDA personnel; the process and procedures for accessing data that are no longer on-line; the lag time between the date of service for the hospitalization and on-line availability of the data; and data collection and management procedures. These characteristics are essential for determining whether the data continues to meet the needs of the FDA for making timely regulatory decisions based on the most current, scientifically valid information available;

E. The Contractor shall also provide a description of the data acquisition status for all data streams for the adult and pediatric hospital inpatient and ED drug utilization and treatment procedure data resource. All data flow and management procedures shall be described, including data acquisition, cleaning, and editing procedures, specification and description of all coding systems used for diagnoses, procedures and drugs, methods for coding data, percentage of missing or incomplete information and method of coding missing data, availability of raw/sample numbers, as well as projected numbers, and the frequency with which data are updated and methods for updates;

F. The Contractor shall provide a description of quality control measures that will ensure access to valid data that is technically correct and conforms to contract requirements. The description shall include methods and timelines of quality control measures to be conducted by the Contractor. This requirement applies to data procured from subcontractors, as well as the data generated or processed by the Contractor;

G. The data resource shall include access to the hospital inpatient and ED data that shall be amenable to analysis at the discharge-level and patient-level. Age and gender of the patient at hospitalization and/or the ED visit shall be required. Hospitalization and/or ED episode data shall be required, and include the dates of the ED visit and/or hospitalization, the length of stay related to the hospitalization, all diagnoses, all procedures, discharge date and disposition. Data related to drug prescriptions shall be required for all drugs administered during the hospitalization and/or ED episode, and shall include the generic and established name for the drug, strength, dosage form, route of administration, date and time of drug administration, treatment dose and treatment duration. Data related to treatment procedures shall be required for all procedures performed during the hospitalization and/or ED episode, and shall include the procedures coded in the International Classification of Diseases (ICD) and Current Procedural Terminology/Healthcare Common Procedure Coding System (CPT/HCPCS) codes, tests performed, as well as the date and time of procedure;

H. The Contractor shall provide access to information relating to the hospitalization episode and ED visits, for example operating room and radiology procedures, and drug use data (anesthetics, contrast agents, etc.), treatment procedures, microbiology data (cultures, sensitivities, antigen testing, etc.), information on admitting diagnosis, drugs at admission, and drugs at discharge. A description of data available on procedures performed and drugs administered shall be provided and shall be accompanied by a description of the degree of bundling of this information with other data and any limitations on the usefulness of these data in making national estimates;

I. FDA requires the ability to use these data to estimate drug utilization and treatment patterns in the total U.S. inpatient and ED population, or to a national sub-population of interest (e.g., children, women of child-bearing age, elderly). This shall require the use of a projection methodology or other appropriate methodology, which shall be valid, reliable, and robust with regard to drug utilization and treatment procedures, specifically, and the methods shall be fully disclosed. Demographics and other relevant characteristics for discharges and patients included in the sample to be used for projection, as well as for the proposed universe, shall be included.

Technical Requirements and Capabilities

J. Access to a data resource for hospital inpatient and ED data for adult and pediatric patients shall be through a currently existing, commercially available, HIPAA-compliant interface tool that shall provide immediate automated access with the capability of providing counts of discharges and patients utilizing drug products in an inpatient setting; and characterizing the hospitalization and ED episode in short-stay hospitals.

K. Provide FDA personnel with the capability to access detailed inpatient data (including drug utilization, diagnosis and treatment procedure data) that are linked with detailed outpatient data (including drug utilization, diagnosis and treatment procedure data);

L. Access to the data resource shall be immediately after award;

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

N. 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. 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. Additionally, FDA shall not support or maintain Contractor’s equipment or personnel on premises;

O. Access shall be through an interface and this interface shall be user-friendly (easy to understand and methods fully disclosed), transparent and flexible for conducting data queries. The interface shall provide both predefined (e.g., canned) and custom reports. The interface shall also include access to national estimates of adult and pediatric discharges and patients stratified by patient demographics [including age in months for pediatric patients <2 yrs old], primary and secondary diagnoses, primary and secondary procedures, length of stay, length of therapy, location of service, time period (month, quarter, year, moving annual total, aggregate time) and hospital characteristics (e.g. region, teaching status, bed size, urban vs. rural). Data related to the drug product shall display the generic and established name of the drug, strength, dosage form, route of administration, and NDC code (if available);

P. Full disclosure of data collection, construction, coding and configuration as well as quality control procedures as required to allow FDA staff to appropriately interpret findings and understand the construction and application of the projection or other appropriate methodology;

Q. The Contractor shall notify FDA within five business days of any changes in their business agreements with their data suppliers. This notification shall include details of the impact of these changes on data quality, data quantity, and overall data characteristics;

R. The Contractor shall ensure that all data are 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;

S. 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 G);

T. The Contractor’s software and interface tools shall be in full conformance or level of conformance with Section 508 standards (Appendix C & D).

CLIN 0002: Hospital Inpatient and Emergency Department Data Unlimited Direct Access to Hospital Inpatient and Emergency Department Data Resource and Services for Pediatric Patients in Short –Stay and/or Free-Standing Pediatrics Hospitals A. Provide FDA personnel with immediate automated access to a currently existing, commercially available data resource for pediatric hospital inpatient and emergency department (ED) data in short-stay and free-standing pediatric hospitals with the capability of providing counts of discharges and patients utilizing drugs and/or treatment procedures;

B. Provide FDA personnel with the ability to use these data to describe national patterns of drug utilization and treatment procedures in the pediatric hospital inpatient and emergency department (ED)settings through the use of projection or other appropriate methodologies that are scientifically sound and transparent to FDA personnel;

C. Provide FDA personnel with direct, unlimited, Internet or network-based access via an interface tool to the entire data resource for pediatric hospital inpatient data and emergency department (ED) data in a multi-user environment and in real time;

D. Provide FDA personnel with the ability to download (or using other means that are compatible large datasets as needed, for the purpose of conducting epidemiological drug safety studies.

Data Requirements

A. The Contractor shall provide continuous access to data resources on hospital inpatient and emergency department (ED) drug product usage and treatment procedures in pediatric patients throughout the length of the contract. For the purpose of this contract, these data shall meet the need of the FDA to access discharge-level and patient-level data describing pediatric hospital inpatient, ED drug use and treatment procedures in short-stay and/or free-standing pediatric hospitals;

B. The Contractor shall provide information on the size and characteristics of the population of hospitals from which the data are derived since these can affect the quality and usefulness of the data and the validity of national projections from the data. Characteristics of the sample shall minimally include: number of hospitals; number and proportion of short-stay and/or free-standing pediatric hospitals, size of hospitals, geographic diversity of hospitals (using census regions if available) (See Appendix B), number of discharges per year, demographic distribution of discharges in the sample, numbers and percentages of discharges per year of special populations of interest to the FDA, including children (ages <17 years), elderly (ages >65 years), pregnancies and deliveries, and patients with serious illnesses including HIV/AIDS and mental illness, types of hospitals, and a description of specialty units within sample hospitals;

C. The Contractor shall provide the number of unique patients hospitalized per year in the sample and their demographic distribution. The FDA has no interest in knowing the identity of any patient, provider, or hospital included in the data resource so the described data provided shall be de-identified;

D. In addition, the following information shall be provided to the FDA: the number of years of valid data available overall and on-line in real time to FDA personnel; the process and procedures for accessing data that are no longer on-line; the lag time between the date of service for the hospitalization and on-line availability of the data; and data collection and management procedures. These characteristics are essential for determining whether the data continues to meet the needs of the FDA for making timely regulatory decisions based on the most current, scientifically valid information available;

E. The Contractor shall also provide a description of the data acquisition status for all data streams for the pediatric hospital inpatient and ED drug utilization and treatment procedure data resource. All data flow and management procedures shall be described, including data acquisition, cleaning, and editing procedures, specification and description of all coding systems used for diagnoses, procedures and drugs, methods for coding data, percentage of missing or incomplete information and method of coding missing data, availability of raw/sample numbers, as well as projected numbers, and the frequency with which data are updated and methods for updates;

F. The Contractor shall provide a description of quality control measures that will ensure access to valid data that is technically correct and conforms to contract requirements. The description shall include methods and timelines of quality control measures to be conducted by the Contractor. This requirement applies to data procured from subcontractors, as well as the data generated or processed by the Contractor;

G. The data resource shall include access to the hospital inpatient and ED data that shall be amenable to analysis at the discharge-level and patient-level. Age and gender of the patient at hospitalization and/or the ED visit shall be required. Hospitalization and/or ED episode data shall be required, and include the dates of the ED visit and/or hospitalization, the length of stay related to the hospitalization, all diagnoses, all procedures, discharge date and disposition. Data related to drug prescriptions shall be required for all drugs administered during the hospitalization and/or ED episode, and shall include the generic and established name for the drug, strength, dosage form, route of administration, date and time of drug administration, treatment dose and treatment duration. Data related to treatment procedures shall be required for all procedures performed during the hospitalization and/or ED episode, and shall include the procedures coded in the International Classification of Diseases (ICD) and Current Procedural Terminology/Healthcare Common Procedure Coding System (CPT/HCPCS) codes, tests performed, as well as the date and time of procedure;

H. The Contractor shall provide access to information relating to the hospitalization episode and ED visits, for example operating room and radiology procedures, and drug use data (anesthetics, contrast agents, etc.), treatment procedures, microbiology data (cultures, sensitivities, antigen testing, etc.), information on admitting diagnosis, drugs at admission, and drugs at discharge. A description of data available on procedures performed and drugs administered shall be provided and shall be accompanied by a description of the degree of bundling of this information with other data and any limitations on the usefulness of these data in making national estimates;

I. FDA requires the ability to use these data to estimate drug utilization and treatment patterns in the total U.S. inpatient and ED population, or to a national sub-population of interest (e.g., children, women of child-bearing age, elderly). This shall require the use of a projection methodology or other appropriate methodology, which shall be valid, reliable, and robust with regard to drug utilization and treatment procedures, specifically, and the methods shall be fully disclosed. Demographics and other relevant characteristics for discharges and patients included in the sample to be used for projection, as well as for the proposed universe, shall be included.

Technical Requirements and Capabilities

J. Access to a data resource for hospital inpatient and ED data for pediatric patients shall be through a currently existing, commercially available, HIPAA-compliant interface tool that shall provide immediate automated access with the capability of providing counts of discharges and patients utilizing drug products in an inpatient setting; and characterizing the hospitalization and ED episode in short-stay and free-standing pediatric hospitals.

K. Provide FDA personnel with the capability to access detailed inpatient data (including drug utilization, diagnosis and treatment procedure data) that are linked with detailed outpatient data (including drug utilization, diagnosis and treatment procedure data);

L. Access to the data resource shall be immediately after award;

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

N. 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. 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. Additionally, FDA shall not support or maintain Contractor’s equipment or personnel on premises;

O. Access shall be through an interface and this interface shall be user-friendly (easy to understand and methods fully disclosed), transparent and flexible for conducting data queries. The interface shall provide both predefined (e.g., canned) and custom reports. The interface shall also include access to national estimates of adult and pediatric discharges and patients stratified by patient demographics [including age in months for pediatric patients <2 yrs old], primary and secondary diagnoses, primary and secondary procedures, length of stay, length of therapy, location of service, time period (month, quarter, year, moving annual total, aggregate time) and hospital characteristics (e.g. region, teaching status, bed size, urban vs. rural). Data related to the drug product shall display the generic and established name of the drug, strength, dosage form, route of administration, and NDC code (if available);

P. Full disclosure of data collection, construction, coding and configuration as well as quality control procedures as required to allow FDA staff to appropriately interpret findings and understand the construction and application of the projection or other appropriate methodology;

Q. The Contractor shall notify FDA within five business days of any changes in their business agreements with their data suppliers. This notification shall include details of the impact of these changes on data quality, data quantity, and overall data characteristics;

R. The Contractor shall ensure that all data are 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;

S. 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 G);

T. The Contractor’s software and interface tools shall be in full conformance or level of conformance with Section 508 standards (Appendix C & D).

The following tasks are required for the data in both CLINs 0001 and 0002 Task 1: Access to Patient Level Dataset Extracts

For regulatory requirements, the Contractor shall provide the FDA with the ability to download (or obtain in a timely manner using other means) and archive data and the means (query file or search logic) used to create it. FDA requires that datasets shall be available on demand and without intervention by the Contractor.

Task 2: Acceptable Projection or Other Appropriate Methodology The Contractor shall provide the FDA with the ability to make national estimates of hospital inpatient and ED drug use using a projection or other appropriate methodology, which shall be valid, reliable, and robust with regard to drug utilization specifically, and the methods fully disclosed and shall be available at contract award.

IDIQ Other Services Additional services to be acquired through individual task orders 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 Studies – Provision of datasets that endeavor to answer a specific question that require additional tools and resources beyond the current interface tool that is provided by the database;

The Contractor shall provide FDA with access to personnel with the ability to access detailed inpatient data (including drug utilization and medical diagnostic data) that is linked with detailed outpatient data (including drug utilization and medical diagnostic data);

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

Validation studies - studies conducted to establish the validity of exposure or outcome ascertainment method. For example, to establish the validity of specific diagnoses recorded in the database as discharge claims as compared to the diagnoses recorded in medical record data from hospitals;

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

3.4 Technical Environment Requirements A. Internet Access The preferred mechanism for data access is via internet. The FDA has direct, desktop access to the Internet. The system shall be web based and be compatible with commonly used web browsers including Internet Explorer 9 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.

B. Number of Users

The FDA shall purchase one site license that will not be dependent upon the exact number of users The FDA shall purchase one site license for 20 certified users with option for up to 10 additional users.

Individuals within the Office of Surveillance and Epidemiology as well as other authorized users within the FDA will need to access these data as appropriate for their work.

C. Data Downloading The FDA uses standard statistical and data management software, such as SAS, Access and Excel, PDF, ASCII, and shall require the ability to download or export data in formats that are compatible with these packages.

D. 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 Mbs network. FDA shall not support dial-in or modem-based access.

E. Security Any client software that is required to be installed on any FDA computers for the purposes of accessing the data shall not use key-logging and/or network capturing functionality to transmit any data from the FDA system except for login information specific to the data and data (e.g. SQL queries or similar methods) accessing the Contractor’s application data sets. Such software add-ons or plugin shall be approved prior and must be approved by the FDA IT department. The contractor is responsible for providing and needed documentations to assist in the approval process. The license shall include post-production maintenance that includes patches, upgrades, and bug fixes if required.

F.

Virtual Private Network (VPN)

The FDA utilizes the virtual private network 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.

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 – to be determined 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 F.o.b. Destination (NOV 1991) 5.1 Deliverables

BASE YEAR

Data Resource and Services for Pediatric Patients in Short-Stay and/or Free-Standing Pediatric Hospitals

Option Year 1

Data Resource and Services for Pediatric Patients in Short-Stay and/or Free-Standing Pediatric Hospitals

Option Year 2

Data Resource and Services for Pediatric Patients in Short-Stay and/or Free-Standing Pediatric Hospitals

5.2 Delivery Instructions email@fda.hhs.gov Attn: (To Be Determined at the Time of Award)

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 12 months and two (2) option years for a total of three years:

Base Period:

February 20, 2017-February 19, 2018 Option Year One: February 20, 2018- February 19, 2019 Option Year Two: February 20, 2019- February 19, 2020 5.4 Quality Assurance Surveillance Plan:

The Contractor shall provide a Quality Assurance Surveillance Plan (QASP) plan detailing procedures and guidelines to ensure the required performance standards or services levels are met throughout the life of this contract. The QASP shall describe the systematic methods used to monitor performance, identify required documentation, and allocate resources. The Government reserves the right to alter or change the surveillance methods in the QASP at its own discretion.

5.5 Performance Evaluation Plan:

Performance shall be evaluated to determine whether or not it meets the threshold of the agreement. When the performance threshold is not met, the COR will notify the Contract Specialist/Officer. The Contractor shall reply to all performance inquiries listed below with the 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 successful Contractor shall provide Disclosure Clearance and Third Party Agreement Service

The successful Contractor shall provide Unlimited Direct Access to Data Resource and Services

The Contractor shall notify the FDA 48 hours in advance of any circumstances resulting in loss of access to the data source due to planned downtime

The Contractor shall notify the FDA within 30 minutes (Monday-Friday, 9:00 AM – 5:00 PM Eastern Time) from the onset of unplanned downtime with an estimate of time as to restoration of access

5.6 Monthly Reports

Contractor shall provide a Monthly Report 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 Part 6-CONTRACT ADMINSTRATION 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), 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. 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 tc \l3 "ARTICLE G.1. PROJECT OFFICER 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 it’s COR designation.

6.4 The contact information for the Contracting Specialist is:

Tara Hobson

5630 Fishers Lane

Rockville, MD 20857

Tara.Hobson@fda.hhs.gov Phone: (240) 402-7586 Fax: (301) 827-7101

6.5 The contact information for the Contracting Officer is:

Department of Health and Human Services

Food & Drug Administration, OAGS

Attn: James Chestnut 5630 Fishers Lane

Rockville, MD 20857

Phone: (240) 402-7570 Email: James.Chestnut@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

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…