Sol_Doc_75F40125R00037.pdf

U.S. FOOD AND DRUG ADMINISTRATION (FDA)

ACCESS TO OUTPATIENT LONGITUDINAL DATA

INDEFINITE DELIVERY INDEFINITE QUANTITY (IDIQ)

75F40125R00037

Access to Outpatient Longitudinal Data IDIQ

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Table of Contents

1. SOLICITATION INFORMATION

2. DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

2.1. PURPOSE OF THE PROJECT

2.2. BACKGROUND INFORMATION

2.3. DESCRIPTION OF TECHNICAL REQUIREMENTS

2.3.1. REQUIREMENTS FOR OUTPATIENT PRESCRIPTION AND PATIENT LEVEL DRUG UTILIZATION DATA ... 3

2.3.2. TECHNICAL REQUIREMENTS AND CAPABILITIES OF THE DATA RESOURCES

2.3.3. CUSTOM PROGRAMMING AND ANALYTICAL SUPPORT (AD-HOC HOURS)

2.3.4. ONSITE OR LIVE VIRTUAL TRAINING PROGRAMS AND TRAINING MATERIALS

2.3.5. ONSITE OR LIVE VIRTUAL KICK-OFF AND ANNUAL MEETINGS

2.3.6. TECHNICAL SUPPORT

2.3.7. MONTHLY PROGRESS REPORTS

2.3.8. DISCLOSURE CLEARANCE FOR AGGREGATED DATA

2.3.9. CLEARANCE FOR THIRD PARTY COLLABORATIONS

2.3.10. AD-HOC TECHNICAL SERVICES

2.4. LEVEL OF EFFORT

2.4.1. PROJECT MANAGER (KEY PERSONNEL)

2.4.2. SENIOR COMPUTER ANALYST

2.4.3. APPLICATION PROGRAMMER

2.4.4. STATISTICIAN

2.4.5. PHARMACIST

2.4.6. SENIOR TRAINING SPECIALIST

2.4.7. SURVEY SCIENTIST

2.4.8. EPIDEMIOLOGIST

2.5. SECTION 508 ACCESSIBILITY STANDARDS

3. INSPECTION AND ACCEPTANCE

3.1. QUALITY ASSURANCE SURVEILLANCE PLAN

3.2. PERFORMANCE EVALUATION PLAN

3.3. ADVANCE UNDERSTANDING

4. DELIVERIES OR PERFORMANCE

4.1. ANTICIPATED DELIVERABLES

4.2. HHS MANDATORY CONTRACTOR TRAINING

4.3. PERIOD OF PERFORMANCE

4.4. FEDERAL HOLIDAYS

4.5. PLACE OF PERFORMANCE

4.6. TRAVEL

4.7. OTHER DIRECT COSTS

5. CONTRACT ADMINISTRATION DATA

5.1. CONTRACT TYPE

5.2. CONTRACT VALUE

5.2.1. IDIQ MINIMUM

5.2.2. IDIQ MAXIMUM

5.3. GOVERNMENT POINTS OF CONTACT

5.3.1. IDIQ CONTRACTING OFFICER

5.3.2. IDIQ CONTRACT SPECIALIST

5.3.3. IDIQ CONTRACTING OFFICER’S REPRESENTATIVE

5.3.4. IDIQ ALTERNATE CONTRACTING OFFICER’S REPRESENTATIVE

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5.4. GOVERNMENT FURNISHED PROPERTY

5.5. ORDERING PROCEDURES

5.5.1. PLACEMENT OF ORDERS

5.5.2. PRICING OF ORDERS

5.6. INVOICING

5.7. AVAILABILITY OF FUNDS

6. SPECIAL CONTRACT REQUIREMENTS

6.1. INTERNET PROTOCOL

6.2. SECURITY REQUIREMENTS

6.3. CONTRACTOR PERSONNEL SECURITY CLEARANCE STANDARDS AND RESIDENCY REQUIREMENTS, DATED

OCTOBER 2017

7. CONTRACT CLAUSES

7.1. FAR CLAUSES

7.2. HHSAR CLAUSES

8. LIST OF ATTACHMENTS

8.1. ATTACHMENT 1 - DATA CHARACTERISTICS TABLE

8.2. ATTACHMENT 2 - GLOSSARY

8.3. ATTACHMENT 3 - DATA DISCLOSURE CLEARANCE PROCEDURES

8.4. ATTACHMENT 4 - DATA DISCLOSURE CLEARANCE FORMS

8.5. ATTACHMENT 5 - CENSUS REGIONS

8.6. ATTACHMENT 6 - TRIAL SUBSCRIPTION AGREEMENT

8.7. ATTACHMENT 7 - FDA SECURE ELECTRONIC MAIL SYSTEM

8.8. ATTACHMENT 8 - ACTIVE FAR & HHSAR CLASS DEVIATIONS

8.8.1. FAR Class Deviation 2020-01 - Flexibilities for the Suspending or Debarring Official’s Correspondence with Contractors

8.8.2. FAR Class Deviation 2020-04 - Eliminate Hard Copy Original Documents, Signatures, Notarization, Seals on Bonds and Other Seals for Certain Contract Requirements

8.8.3. FAR Class Deviation 2022-01 - Requirements for Nonavailability Determinations Under the Buy American Act

8.8.4. FAR Class Deviation 2024-01 – Small Business Administration (SBA) 8(a) Program Offer and Acceptance and Eligibility Verification

8.8.5. FAR Class Deviation 2024-03 - Legal Challenges to Executive Order (E.O.) 14026, Increasing the Minimum Wage for Federal Contractors

8.8.6. FAR CLASS DEVIATION 2025-01 AMENDMENT 1 - executive order (eo) 14173 and EO 14168

8.8.7. FAR CLASS DEVIATION 2025-02 Amendment 1 - Section 2 of the Executive Order (EO) 14148, “Initial Rescissions of Harmful Executive Orders and Actions,” which revoked EO 14057 and Section 2 of EO 14208, “Ending Procurement and Forced Use of Paper Straws"

8.8.8. HHSSAR Class Deviation 2023-01 - Standards for Health Information Technology

8.8.9. HHSAR Class Deviation 2023-02 - Implementation of the Make Personal Protective Equipment (PPE) in America Act Requirements

8.8.10. HHSAR Class Deviation 2024-01, Amendment 1 - Supply Chain Risk Management

8.8.11. HHSAR Class Deviation 2025-01 - Supply Chain Risk Assessments

8.8.12. HHSAR Class Deviation 2025-02 - Updates to HHSAR Parts 309, 322, 323, 337, and 352

8.9. ATTACHMENT 9 - HHS SUBCONTRACTING PLAN

8.10. ATTACHMENT 10 - EXAMPLE OF MONTHLY REPORT

8.11. ATTACHMENT 11 - PAST PERFORMANCE WORKSHEET

8.12. ATTACHMENT 12 - PAST PERFORMANCE QUESTIONNAIRE

8.13. ATTACHMENT 13 - PRICING WORKSHEET

8.14. ATTACHMENT 14 - TASK ORDER STATEMENT OF WORK

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9. REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS OR RESPONDENTS

9.1. FAR PROVISIONS

9.2. HHSAR PROVISIONS

10. INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS OR RESPONDENTS

10.1. VOLUME I: TECHNICAL PROPOSAL INSTRUCTIONS

10.1.1. TECHNICAL FACTOR 1: TECHNICAL APPROACH

10.1.2. TECHNICAL FACTOR 2: TRIAL SUBSCRIPTION

10.1.3. TECHNICAL FACTOR 3: RELEVANT EXPERIENCE

10.2. VOLUME II: BUSINESS/PRICE PROPOSAL INSTRUCTIONS

10.3. VOLUME III: PAST PERFORMANCE PROPOSAL INSTRUCTIONS

10.4. VOLUME IV: SUBCONTRACTING PLAN PROPOSAL INSTRUCTIONS

11. EVALUATION FACTORS FOR AWARD

11.1. VOLUME I: TECHNICAL PROPOSAL EVALUATION CRITERIA

11.1.1. TECHNICAL FACTOR 1: TECHNICAL APPROACH

11.1.2. TECHNICAL FACTOR 2: TRIAL SUBSCRIPTION

11.1.3. TECHNICAL FACTOR 3: RELEVANT EXPERIENCE

11.2. VOLUME II: BUSINESS/PRICE PROPOSAL EVALUATION CRITERIA

11.3. VOLUME III: PAST PERFORMNACE PROPOSAL EVALUATION CRITERIA

11.4. VOLUME IV: SUBCONTRACTING PLAN PROPOSAL EVALUATION CRITERIA

1. SOLICITATION INFORMATION

This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with the format in subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

The solicitation is issued as a request for proposal (RFP) in accordance with the procedures of FAR Part 12, Acquisition of Commercial Products and Commercial Services, in conjunction with the policies and procedures for solicitation, evaluation and award prescribed in FAR Part 15, Contracting by Negotiation.

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2025-03, effective January 17, 2025.

The Government anticipates awarding a multiple-award Indefinite-Delivery Indefinite-Quantity (IDIQ) contract. The Government anticipates issuing two (2) awards to the Offerors who represent the best value to the Government, technical, price and other factors considered, in accordance with the evaluation criteria set forth in this solicitation; however, the Government may make additional awards if determined to be in the best interest of the Government. This RFP is unrestricted; however, the Government will reserve a minimum of one (1) additional award for a small business concern who is determined to be technically capable and who is determined to have proposed a fair and reasonable price, in accordance with the evaluation criteria set forth in this solicitation. The small business program eligibility requirements apply. The North American Industry Classification System (NAICS) code is 541519 with a small business size standard of $34 million or 150 employees.

Offerors must have an active registration in SAM.gov when submitting a proposal and at time of award in order to comply with the annual representations and certifications requirements. Proposals submitted by Offerors without an active registration in SAM.gov or without completed representations and certifications by the close date of the solicitation may not be considered.

2. DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

2.1. PURPOSE OF THE PROJECT

The goals and objectives of this requirement is to provide FDA personnel with:

a. Real-time, unlimited, immediate, direct, multi-user, desktop access to currently existing, commercially available, longitudinal data with the capability of providing current and historical national-level and geographical/sub-national counts of outpatient prescriptions over time.

b. Real-time, unlimited, immediate, direct, multi-user, desktop access to currently existing, commercially available, longitudinal data with the capability of providing current and historical national-level and geographical/sub-national counts of unique patients over time who received dispensed prescription drug products from outpatient settings.

c. Prescriptions, medical claims, and patient-level demographic information, in either the same or separate, linked resources. If separate linked data resources are proposed, all individuals in the patient-level data resource shall link directly to their dispensed prescription data.

d. The ability to use these data to characterize the duration of drug exposure to prescription drug products at the patient level and to examine concomitant use of drug products at the patient level.

e. The ability to use these data to analyze and describe national-level estimates of drug utilization 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.

f. Direct, unlimited, internet- or network-based access to all HIPAA-compliant data in a multi-user environment and in real-time.

g. The ability to download (or obtain in a timely manner using other means) large datasets as needed.

2.2. BACKGROUND INFORMATION

A vital part of the U.S. Food and Drug Administration (FDA) and Center for Drug Evaluation and Research (CDER) mission is to protect the public health. Offices within CDER take a variety of approaches to meet these broad goals. For example, 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 response to reports from the Institute of Medicine (IOM), FDA is authorized by the FDA Amendments Act (FDAAA) of 2007 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 FDAAA calls for enhanced authorities for access to 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 setting1.

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

1 PUBLIC LAW 110–85—SEPT. 27, 2007

https://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf post market surveillance data to enable the Agency to respond promptly to serious public health issues2.

The ability of FDA to respond expeditiously to the increasing number of drug safety issues is crucial to the overall public safety. Access to outpatient prescription and patient level data will complement and strengthen the utility of FDA’s Adverse Event Reporting System (FAERS) currently in place by providing estimates of the numbers of patients exposed to drugs and the numbers of prescriptions dispensed nationwide in the outpatient setting. These data 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 outpatient setting.

Access to these data also increases the FDA’s ability to perform regulatory impact studies; in particular, those studies that assess the impact of risk management plans and labeling changes on prescribing habits and usage patterns for prescription drugs. Finally, direct access to these data in real time enhances and accelerates the pace of FDA's regulatory decision-making process.

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.

2.3. DESCRIPTION OF TECHNICAL REQUIREMENTS

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

2.3.1. REQUIREMENTS FOR OUTPATIENT PRESCRIPTION AND PATIENT LEVEL DRUG

UTILIZATION DATA

The Contractor shall:

a. Provide continuous automated access to nationally-based, outpatient prescription-level data. The data shall include historical prescription information at a national and sub-national level.

b. Provide patient-level data describing outpatient prescription drug use in individuals longitudinally. The prescription claims data and medical claims data shall provide immediate automated access with the ability to provide counts of current and historical aggregate national and sub-national drug utilization information. The longitudinal data shall include information at the medical claim and prescription claim levels with the ability of characterizing concomitant drug use and characterizing duration of drug exposure. The medical claims data shall provide immediate automated access with the ability to provide counts of current and historical aggregate national and sub-national drug utilization information.

c. Provide a description of the Contractor’s data acquisition process for the prescription claims and medical claims data. All data flow and management procedures shall be

2 H.R. 34 21st Century Cures Act https://www.congress.gov/114/bills/hr34/BILLS-114hr34enr.pdf described, including data acquisition, cleaning, and editing procedures, data de-identification procedures, specification and description of all coding systems used for diagnoses, procedures and drugs, including versions (e.g. ICD-9, ICD-10), methods for coding data, percentage of missing or incomplete information and the 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. For each health care setting, the Contractor shall estimate the proportion captured in the data source out of the entire market and provide this estimation to FDA, updated at least semi-annually. A current and complete updated data dictionary and database description shall be provided annually and as changes are made.

d. Provide the total number of years of data available overall and the number of years available online and accessible in real-time to FDA personnel. A minimum total of ten

(10) years of data (minimum of five (5) years of data available online and at a minimum an additional five (5) years of historical data that is no longer online), and propose methods to obtain historical data in a timely manner. FDA’s preference is that historical datasets be available on demand and without intervention from the Contractor.

The Data shall include:

a. Prescription-level data currently existing, commercially available, HIPAA-compliant product that shall provide immediate automated access.

b. Prescription-level data with the ability of analyzing current and historical aggregate national and sub-national dispensed prescription information at a minimum of monthly-level, with the ability to aggregate data by time periods specified by the user. Patient-level data shall provide the ability to analyze unique patients utilizing drug products in an outpatient setting, with the capability of stratifying by patient age and sex. Data shall have the capability of customizing patient age bands as needed. Patient-level data shall link to prescription-level data, allowing for the assessment of new versus continuing use of drugs at the molecule level and at the drug class level.

c. The size and characteristics of the population of patients or covered lives from which the prescription- and patient-level data are derived shall be provided to FDA, since these can affect the quality and usefulness of the data provided and the validity of national projections from the data. Characteristics shall minimally include: number of individual patients or covered lives per calendar quarter; number and percent of patients or covered lives with at least two years of continuous activity; number and percent of patients or covered lives with corresponding enrollment information; availability of enrollment/eligibility/participant inclusion information for use in data analyses; number and percentage of active patients or covered lives in populations of special interest to FDA (including children [ages ≤ 17 years], females of child-bearing age, and elderly [ages ≥ 65 years]); turnover or churn rate for participation in the data resource; the method by which patient age is obtained; geographic diversity; patient demographics; coverage or inclusion policies relevant to pharmaceutical products under health care plans providing the majority of the data; and availability of medical claims data. The number and percent of the total population for whom clinical/medical data or data capturing the administration of drug or biologic products in the outpatient setting by healthcare professionals are available and detailed information describing how this information is linked to the pharmacy data is required. These longitudinal data shall follow uniquely identifiable individuals (using encrypted patient identifiers) and physicians over time either across or within ambulatory health care plans. Patient age and sex shall be provided. Information on race/ethnicity shall be accompanied by documentation of the origin of this information, if available.

d. Prescription data with the therapeutic class of drug and biologic products (including biosimilars and interchangeable biosimilars), molecule(s), active ingredient(s) (e.g., single-ingredient or combination), molecular salt (if applicable), product name (U.S.

proprietary and non-proprietary), original prescribed product, substitution allowability, strength, National Drug Code (NDC), company name (manufacturer or corporation), dosage form, strength, all dates dispensed, quantity dispensed, dispensed days’ supply, prescriber specialty, and method of payment. The Contractor shall provide the ability to obtain all data elements within a single dataset extract. The Contractor shall provide a history of dataset adjustments and corrections over the past 3 years.

e. Medical claims with the start date and end date of the medical event, the type of medical claim (e.g., inpatient claim, outpatient facility claim), medical specialty of the practitioner(s) involved, and the following data elements as dictated by the type of medical claim: International Classification of Diseases (ICD) diagnosis code(s), admitting diagnosis code, discharge diagnosis code(s), version indicator (e.g. ICD-9, ICD-10), and procedure code(s) (e.g. CPT, HCPCS) with source indicator. Current data shall include patient-level demographic information as well as a link to a patient's current and historical prescription drug use.

f. Direct access to weekly data with the capability of providing current and historical national-level and sub-national level counts of prescriptions and unique patients over time, delivered weekly with no more than an eight calendar (8) day lag.

g. Direct access to monthly data with the capability of providing current and historical national-level and sub-national level counts of prescriptions and unique patients over time, delivered monthly with no more than a thirty (30) calendar day lag.

h. Capability to provide data in weekly, monthly, quarterly and annual outputs.

i. Ability to use both the prescription-based outpatient data and patient-based outpatient data to estimate drug utilization patterns in the total U.S. outpatient population, or in a national sub-population of interest (e.g., children [≤ 17 years], females of child-bearing age, elderly [≥ 65 years]). This shall require the use of projection or other appropriate methodologies which shall be valid, reliable, and robust with regard to drug utilization specifically. The methods of national level estimation (projection or other methodology) shall be fully disclosed.

j. Claims-level data, such as prescriptions or medical claims including a de-identified patient

ID for linking patients across claims and a de-identified health care practitioner ID for linking practitioners across claims. 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, but the methods used to de-identify the data shall be described.

2.3.2. TECHNICAL REQUIREMENTS AND CAPABILITIES OF THE DATA RESOURCES

The Contractor shall:

a. Provide outpatient prescription longitudinal patient-level data that is currently existing and commercially available. Access to the data shall be immediate, unlimited, direct, desktop and in real-time. Direct access shall include all upgrades, enhancements, and modifications to software and data.

b. Provide access through an existing interface and this interface shall be user-friendly, transparent and flexible enough to meet the FDA’s needs. Minimally, the interface shall provide both predefined (e.g., canned) and custom reports.

c. Provide full disclosure of data collection, construction, coding, and configuration that are required to allow FDA staff to appropriately interpret findings and understand the construction and application of the projection or other appropriate methodology.

d. Provide access to the data resources accessible via a secure internet or network-based method permitting simultaneous, multi-user access through a user-friendly data query tool(s).

e. Provide the FDA the ability to immediately, directly download data in an automated fashion—without any intervention needed from the Contractor—in the following formats: Microsoft Excel, comma- or tab-separated file, and text delimited file. The Contractor shall provide the ability to directly download data in both a hierarchical format as well as a flat file (a file where a record contains data for each user-selected data field).

For downloading datasets larger than 100 megabytes, the Contractor shall provide a manner which is compatible with FDA security procedures. The data query tool shall allow the user to download information regarding the user-selected specifications for each query, such as time period selected, drugs selected, dosage form selected, the dataset used, and the date that the query was run.

f. Provide FDA with a fourteen (14) calendar day trial subscription. The Contractor shall provide a live virtual web-based training session that lasts a maximum of two (2) hours at the start of the trial subscription period. The trial subscription shall include direct access, documentation, and technical support for a maximum of seven FDA users. The FDA will not pay for this subscription as access will be used solely to assess whether the contractor meets the data requirements, and not for any analyses, public disclosure, or regulatory decision making.

g. Specify any additional software name and version) necessary to access the data. Any software installed on FDA computers for the purposes of accessing the data shall not use keylogging or network capturing functionality to transmit any data from the FDA system.

Exceptions are for login information specific to the data vendor and dataset, and procedures for querying the Contractor’s data sets, such as SQL (Structured Query Language).

h. Conform to Section 508 standards. The data vendor shall participate in the FDA secure electronic mail system 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 Internet Protocol Security (IPSEC) protocols.

i. Notify the FDA in the event of changes to the Contractor’s business or agreements with their data suppliers within five (5) business days of the Contractor becoming aware of such changes. This notification shall include details of the impact of these changes on data quality, data quantity, and overall data characteristics.

2.3.3. CUSTOM PROGRAMMING AND ANALYTICAL SUPPORT (AD-HOC HOURS)

The Contractor shall provide additional analytical and programming support, to enable FDA personnel to obtain prescriptions, patients, claims and any other utilization metrics not available through the online data tools. The FDA estimates a potential need of up to 200 ad-hoc hours annually. The Contractor may need to provide additional hours of ad-hoc data analyses, custom queries, or raw data preparation not available through the data tools and in increments to be determined at the Task Order level.

2.3.4. ONSITE OR LIVE VIRTUAL TRAINING PROGRAMS AND TRAINING MATERIALS

The Contractor shall provide training for users of the data, as well as training for FDA personnel who shall support use of the data (e.g., technical users). The Contractor shall provide a minimum of two onsite or live virtual training sessions per year as required by the FDA. Live or web-based training of FDA personnel shall be offered for any modifications, enhancements, or upgrades to the data source.

The Contractor shall provide course outlines for all levels of training offered live virtually or on site at FDA (Silver Spring, MD) and options for additional “on-demand” sessions either in person or via web-based methods. The training shall be initiated within thirty (30) calendar days of award and continue throughout the duration of the contract.

2.3.5. ONSITE OR LIVE VIRTUAL KICK-OFF AND ANNUAL MEETINGS

The Contractor shall participate in a kick-off meeting within two weeks of contract award and shall conduct an annual meeting live virtually or on-site (at the FDA’s discretion), at the FDA White Oak 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.

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2.3.6. TECHNICAL SUPPORT

The Contractor shall provide a support package comprised of written documentation that includes technical, analytical, and clinical support throughout the length of the contract. The support package shall include any modifications, enhancements, or upgrades to the data source.

The Contractor shall provide ongoing technical, analytical, and clinical support by phone or by e-mail during business hours (9:00 am to 5:00 pm, ET), Monday through Friday, excluding Federal holidays (available at www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/), throughout the length of the contract. This support shall be in accordance with the service levels established in the contract.

The Contractor shall have dedicated client support personnel to serve as a liaison between the FDA and the Contractor to ensure effective communication and access to needed resources.

2.3.7. MONTHLY PROGRESS REPORTS

The Contractor shall provide Monthly Reports by 20th of each month for the previous month data detailing use of the resource by individual FDA users and type of use clearances, third party agreements, number of ad-hoc programming hours used and project title (See Attachment 10 - Example of Monthly Report) and shall include the following:

a) Number and type of data queries by individual FDA user.

b) Clearance Requests shall include type of data submitted, project title, FDA requestor, date of request, and approval date.

c) Third Party Agreement Requests shall include third party collaborator, project title, FDA principal investigator, date of request, approval date, and expiration date.

d) Ad-hoc Dataset Requests shall include the number of technical support programming hours used, project title, FDA requestor, date of request, and date received.

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

f) Status update on each task worked on and deliverables submitted, any problems encountered, and suggestions for addressing problems each period.

g) If the tasks are cost reimbursable in nature, an accounting of applicable staff who worked on the tasks as well as any deviations from the original projection of hours planned vs.

actually incurred shall be required.

2.3.8. DISCLOSURE CLEARANCE FOR AGGREGATED DATA

As part of its regulatory activities, FDA requires 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 FDA Data Disclosure Clearance Procedures and Form found in Attachment 3 and Attachment 4 unless a different Data Disclosure Clearance Procedure process proposed by the Offeror is approved in advance by FDA. 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 of performance. After Ordering http://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/

Period V, FDA will not require data access service, but will require the services of processing clearance requests. After Ordering Period V, the FDA will notify the Contractor of the aggregated data release for projects initiated prior to the end of the contract and accept the Contractor’s requested revisions for a maximum of one year but will not require formal approval for release.

2.3.9. CLEARANCE FOR THIRD PARTY COLLABORATIONS

As part of its regulatory activities, FDA engages in collaborative research projects with third parties outside of FDA that are initiated by and conducted for the benefit of FDA. These collaborations shall require FDA to have the ability to share project-specific aggregated or raw data with third parties for collaborative research projects. For these collaborations that require sharing of aggregated or raw data, the Contractor shall accept and adhere to the Data Disclosure Clearance Procedures and form to be found in Attachment 3 and Attachment 4 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.

2.3.10. AD-HOC TECHNICAL SERVICES

The Contractor shall provide additional quantities of services including, but not limited to:

a. Validation Studies – Studies that are conducted to establish soundness or validity of a particular method used, for example to validate indications for treatment in the database using the claims data.

b. Projection Methodology Studies – Developing methods that shall allow projecting the number of prescriptions or patients based on the sample data.

c. Concomitant Drug Use Analysis – Analyses on the concomitant use of two or more drugs from the same or different therapeutic classes indicated to treat the same or different diagnosis.

d. 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 enough population size to determine a significant association or non-significance association between exposure and outcome.

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

f. Tool Enhancement – Expanding the tool capabilities beyond the current offering to improve data access and analysis.

g. Ability to access other outpatient data and tools that allows more granular perspective such as by geography (e.g., County, State, Metropolitan Statistical Area), and time (e.g., weekly) within the vendor’s data suite.

h. Ability to link/access additional data sources including electronic medical records within the vendor’s data suite to provide a comprehensive view of the drugs being analyzed.

2.4. LEVEL OF EFFORT

The following is a description of labor category responsibilities and qualifications.

2.4.1. PROJECT MANAGER (KEY PERSONNEL)

The Project Manager shall have a minimum of a master’s degree or an equivalent certification and at least five (5) years of experience managing projects.

The 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

2.4.2. SENIOR COMPUTER ANALYST

The Senior Computer Analyst shall have the required certification with a minimum of eight (8) years of experience in the field.

The Senior Computer Analyst:

• Analyzes science, engineering, business, and other data processing problems to implement and improve computer systems

• Analyzes 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

2.4.3. APPLICATION PROGRAMMER

The Application Programmer shall have the required certification with a minimum of five (5) years of experience in the field.

The Application Programmer:

• Devises or modifies procedures to solve complex problems considering computer equipment capacity and limitations, operating time, and form of desired results

• Designs, codes, tests, debugs, and documents

2.4.4. STATISTICIAN

The Statistician shall have at least ten (10) years of experience and training in economics, finance, statistics, or related areas and a demonstrated record of supporting development and delivery of presentations, publications, and reports on specific programs or technically complex subjects.

The 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

2.4.5. PHARMACIST

The Pharmacist shall be licensed in any state with a minimum of ten (10) years of experience in the field.

The Pharmacist:

• Dispenses drugs prescribed by physicians and other health practitioners and provide information to patients about medications their use

• May advise physicians and other health practitioners on the selection, dosage, interactions, and side effects of medications

2.4.6. SENIOR TRAINING SPECIALIST

The Senior Training Specialist shall have a minimum of eight (8) years of experience in the field or in a related area and shall have a Bachelor's degree in a related area or equivalent.

The 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

2.4.7. SURVEY SCIENTIST

The Survey Scientist shall have at least five (5) years of experience in Healthcare System.

The Survey Scientist:

• Performs survey research tasks of significant technical complexity, applying standard and established. concepts, and techniques but often using innovative approaches and/or complex statistical analyses

• Develops or directs the development of innovative and creative technical solutions to research problems

2.4.8. EPIDEMIOLOGIST

The Epidemiologist shall be a registered in any state with a minimum of ten (10) years of experience in the field.

The Epidemiologist:

• Investigates patterns and causes of disease and injury in humans

• Seeks to reduce the risk and occurrence of negative health outcomes through research, community education, and health policy

2.5. SECTION 508 ACCESSIBILITY STANDARDS

The following list of Section 508 accessibility standards of the Access Board EIT Accessibility Standards are applicable to this acquisition:

• Must meet WCAG 2.0 A and AA

• E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

• E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

• E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements)

• E205 Electronic Content (Appendix A, Application and Scoping Requirements)

• E208 Support Documentation and Services (Appendix A, Application and Scoping

Requirements)

• Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and Technical Requirements)

• 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and

Technical Requirements)

• Electronic content must be accessible to HHS acceptance criteria.

• Accessibility checklists for various formats are available at the HHS site. Materials that are final items must be compliant with Section 508 at time of delivery, except upon approval of the Contracting Officer or Representative.

• E207 Software (Appendix A, Application and Scoping Requirements)

• Chapter 5 Software (Appendix C, Functional Performance Criteria and Technical

Requirements)

Section 508 of the Rehabilitation Act Amendments of 1998 (29 U.S.C. § 794 (d) was enacted in the Workforce Investment Act of 1998. Section 508 requires that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities. The Act required the Architectural and Transportation Barriers Compliance Board (Access Board) to create federal standards for electronic and information technology (EIT) products (goods and services) to make them more accessible by individuals with disabilities.

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

1. Conformance at proposal submission

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

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

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

Using the following web site, Offerors can access resources for understanding and implementing the requirements of Section 508: http://www.section508.gov.

https://www.levelaccess.com/wcag-a-and-wcag-aa-conformance/ https://www.access-board.gov/ict/#E101.2 https://www.access-board.gov/ict/#E203-functionality https://www.access-board.gov/ict/#E204-functional-performance-criteria https://www.access-board.gov/ict/#E205-content https://www.access-board.gov/ict/#E208-documentation-Services https://www.access-board.gov/ict/#chapter-6-support-documentation-and-services https://www.access-board.gov/ict/#302-functional-performance-criteria https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.access-board.gov/ict/#E207-software https://www.access-board.gov/ict/#chapter-5-software http://www.section508.gov/

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

§ 1194.21 Software applications and operating systems.

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

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

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

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

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

(f) Textual information shall be provided through operating system functions for displaying text.

The minimum information that shall be made available is text content, text input caret location, and text attributes.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Note to §1194.22:

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

Section 1194.22 Paragraph WCAG 1.0 Checkpoint

(a) 1.1

(b) 1.4

(c) 2.1

(d) 6.1

(e) 1.2

(f) 9.1

(g) 5.1

(h) 5.2

(i) 12.1

(j) 7.1

(k) 11.4

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

§ 1194.31 Functional performance criteria.

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

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

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

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

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

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

§ 1194.41 Information, documentation, and support.

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

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

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

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

§ 1194.23 Telecommunications products.

§ 1194.24 Video and multimedia products.

§ 1194.25 Self-contained, closed products.

§ 1194.26 Desktop and portable computers.

3. INSPECTION AND ACCEPTANCE

The Contracting Officer’s Representative (COR) shall, in accordance with FAR 52.212-4, perform inspection and acceptance of all the services. Inspection and acceptance shall be performed at the location identified in individual task orders. Acceptance shall be communicated within thirty (30) calendar days of receipt in writing.

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

3.1. QUALITY ASSURANCE SURVEILLANCE PLAN

The Contractor shall provide a Quality Assurance Surveillance Plan (QASP) detailing the procedures and guidelines to ensure the required performance standards or services levels, specified in the performance evaluation plan, 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.

3.2. PERFORMANCE EVALUATION PLAN

Performance shall be evaluated to determine whether it meets the threshold of the agreement. When the performance threshold is not met, the FDA COR shall notify the Contract Specialist/Officer. The Contractor shall reply to all performance inquiries listed below with a resolution within fifteen (15) business days of receipt.