FDA-SOL-1159692.pdf

FDA-SOL-1159692

- 1 -

PART I

SECTION 1 - SUPPLIES OR SERVICES AND PRICES/COSTS

1.1 SOLICITATION DESCRIPTION

The Contractor shall furnish all necessary facilities, materials, and personnel, and shall perform all non-personal services and program support necessary in a requirement titled, “openFDA Support.”

This is a combined synopsis/solicitation for commercial items 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.

This solicitation is a Request for Proposals (RFP). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-80. The associated North American Industrial Classification System (NAICS) code for this procurement is 541511. Its associated Small Business Size Standard is $27.5 million.

This requirement is for a small business Set-Aside as a result of this combined synopsis/solicitation.

1.2 CONTRACT TYPE

The government intends make a single award Indefinite Delivery/Indefinite Quantity (IDIQ) type contract with the issuance of firm-fixed price, labor-hour and time and materials task orders. The structure of the contract shall be a base period of one (1) year followed by four (4) separate option periods. The total potential period of performance should all four (4) options be awarded is five (5) years.

1.3 CONTRACT CEILING

The IDIQ guaranteed minimum amount will be $1,000.00 over five (5) years inclusive of options. The contract maximum ceiling amount will be $10,000,000.00 over five (5) years inclusive of options.

1.4 PRICING

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 fully burdened fixed hourly rates.

http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/12.htm#P295_49268

- 2 -

Labor Rate Pricing Chart:

Labor Category* Estimated

Annual Hours

Year 1 Hourly Rates (Base)

Year 2 Hourly Rates

(Option #1)

Year 3 Hourly Rates

(Option #2)

Year 4 Hourly Rates

(Option #3)

Year 5 Hourly Rates

(Option #4) Product Manager 1,268

Technical Writer/ Editor and communication specialist

1,128

Data Scientist 2,221

Data Engineer 3,623

Usability Experience

(UX) Designer 1,224

Total (for evaluation purposes only)

See Attachment 4 for excel spreadsheet format.

The material handling fee applicable to other direct costs is: ________

Note: Reference Section 2.5 for a full description of each labor category.

SECTION 2 - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

2.1 BACKGROUND

The Office of Health Informatics (OHI), led by the Chief Health Informatics Officer (CHIO), examines and employs innovative concepts, tools and technologies to support the Food and Drug Administration’s (FDA, also “the Agency” in this document) mission of promoting and protecting the USA’s public health. The CHIO also has the primary goal of making public FDA data available to developers for use in their developed applications. As a result the CHIO is focused on promoting Information Technology (IT) solutions and capabilities that can quickly and cost-effectively support collaborative activities in the public domain. The ability to rapidly deploy and consistently manage information and resources in this setting plays a critical role in enabling FDA’s efforts to transform Agency operations and respond quickly and accurately to emerging scientific, technological, and economic trends affecting its regulatory mission. Another key role of the CHIO is to act as a catalyst and agent for innovation and change, piloting new technical concepts using agile development methodologies to pilot and prototype new capabilities before committing to their use. A key challenge of the FDA is to develop an

- 3 -efficient bidirectional communications capability enabling FDA to fulfill its medical countermeasures (MCM) mission when addressing public health threats and adverse events. The expectation is that the contractor shall collaborate and coordinate with other support contractors and service providers as needed to support the mission of the FDA.

2.2 OBJECTIVE

OHI has a requirement for the specific skill set necessary for FDA’s public data and highlight projects using these data in both the public and private sector to further FDA’s regulatory mission, further science, and educate the public. These contract resources will be combined with existing staff to form an integrated project team with all the necessary skills to operate, maintain, update, and enhance the openFDA project (https://open.fda.gov).

openFDA is an application external to FDA and is built utilizing open source code. This code is published on websites such as Github. The cloud storage location with the data currently resides on Amazon Web Services, which could be subject to change.

openFDA updates is needed to keep the data, harmonization of the data, code, and documentation current. Enhancements are needed to maintain the existing platform and add new Application Programming Interface (API)s and functions to the platform. The platform allows users to download entire datasets in standard formats (i.e., XML or CSV), find and visualize subsets of datasets with the openFDA API, or develop their own IT application that leverages the openFDA APIs to provide a data service or data analysis service. Additionally, operating the platform includes responding to the openFDA community in various forums such as StackExchange, GitHub, and the openFDA email box. The community discusses various aspects of openFDA including code questions, enhancements, and bug reports.

There are additional key aspects of openFDA. OpenFDA community members (users, FDA organizations separate from the openFDA team [contractor, FDA COR, and select FDA staff], and other organizations) may contribute new datasets (in the form of APIs) or open code. The contractor will facilitate incorporation of, or linkages with, any of these as directed by the openFDA COR.

As the openFDA community grows, it may become necessary to provide measures (such as API size, API usage, etc.) that could inform sharing costs among more than one organization.

Other important functions include but are not limited to:

• The contractor shall maintain the site where FDA publishes a list of open data that HHS pulls into its own database and update it with quarterly files provided by FDA staff.

https://open.fda.gov/

- 4 -

• The contractor shall maintain the platform and infrastructure site where FDA publishes a suite of interactive analytical tools that work on openFDA APIs. FDA will maintain and update the analytic code.

• The Contractor shall move openFDA to another platform (similar or different from the current one) or cloud vendor, if the need arises.

2.3 SCOPE OF WORK

Activities under the proposed contract shall include, but are not limited to, the following:

OHI seeks to accomplish the following items under this contract:

• enhance existing openFDA APIs;

• operate and maintain the existing openFDA platform and environment;

• add new FDA public datasets to the openFDA platform;

• facilitate addition of or linkages with new APIs by third parties;

• conduct data harmonization of existing and new added APIs;

• create training materials related to FDA’s open data project;

• engage developer community via code-a-thons and speaking engagements;

• update and maintain the openFDA website;

• provide subject matter expertise on the various community tools leveraged to address questions; and

• enhance the platform, code, and environment.

Additional functions may include, maintaining the platform and infrastructure of all and update the content of one. OHI may also seek to move openFDA to another similar or different platform, maintain the cloud account, move to another cloud, and/or provide measures of API hosting or use.

2.4 STATEMENT OF WORK

A. Tasks to be performed by the Contractor (Tasks Orders may include one, some, or all tasks listed below):

Task 1: OpenFDA Website Maintenance, Updating, Enhancements, Expansion, and End User Support

A. Website Maintenance and Updating – Operate and maintain the openFDA website and platform to 1) support external developers’ continued use of the APIs, API references, and openFDA portal, and 2) support existing additional functions.

a. Verify operating status through use of an alarm to contractor when all or part of openFDA fails.

b. For times when all or part of openFDA fails, notify the user community (i.e., via Twitter) within 10 minutes, document the circumstances, problem-solving tactics, and results, and notify the user community within 10 minutes of when operations resume.

- 5 -

c. For data that the openFDA team obtains directly from www.fda.gov, monitor the source webpages and their associated webpages for changes to the dataset format and documentation.

d. Maintain and update the APIs, including ensuring that the data and harmonization are current.

e. Maintain several prior versions of all the APIs to roll over to when all or part of openFDA APIs fail. Maintain documentation to alert users when a prior version is the one being offered to the public.

f. Maintain and update raw datasets and make available for users to download in raw format. Provide file descriptions and download instructions.

g. Maintain communications with the openFDA community by supporting announcements on the openFDA site and in social media.

h. Update and maintain the API key management plan, along with list of authorized users (type of industry, geographic location), log of requests (source, date, time, speed of reply), and performance during peak demand periods.

i. Maintain all application and server configurations for the entire openFDA platform (infrastructure, platform, software, APIs, etc.), API Umbrella (or equivalent), and infrastructure configurations in the service in the cloud.

j. Maintain the site function where FDA publishes a list of open data, that HHS pulls into its own database. The contractor shall maintain the site and update it with quarterly files.

k. Maintain the platform and infrastructure for the additional site function where FDA publishes a suite of interactive analytical tools that work on openFDA APIs. The contractor shall maintain the platform and infrastructure. FDA will maintain and update the analytic code.

B. API Enhancement/Integration –Enhance and further integrate the existing openFDA API platform and environment.

a. Provide expertise to develop one or more Application Programming Interfaces (APIs) using REST or other light weight conventions that can be used by custom applications and other solutions to access open data.

b. As additional standard product information becomes available to openFDA.gov, perform data harmonization against existing APIs.

c. Refactor underlying code to enhance the efficiency of the update process or efficiency of response to and scalability of API queries.

d. Add additional site functions.

e. End User Support – Provide end user support including:

• answering questions on the various community resources (i.e GitHub, StackExchange, Twitter, and openFDA emails),

- 6 -

• improving reference materials, and explaining enhancements.

Task 2: Expansion of the openFDA platform with additional APIs A. Design, develop, and deploy additional FDA public datasets as APIs to the openFDA platform.

a. Conduct analysis on the data structure, design the API structure, and produce developer material for each API added to the platform.

b. Develop and execute a technical plan to make each new dataset available in the raw downloadable format.

B. Conduct harmonization against existing APIs as described in Attachment 3.

a. Load the API and produce user reference material.

b. Load the code and developer documentation as part of the expansion.

Task 3: OpenFDA Training Events and External Engagements A. Develop and deliver a day of openFDA training customized to a US audience to be specified by FDA (FDA vs. nonFDA; IT programmer vs. not an IT programmer; application developer vs. public health regulator vs. researcher

vs. general public). The training will be local to the audience, at a US location to be determined and provided by FDA. The format will be a combination of lecture, live examples, and hands-on supervised practice.

Task 4: Integration of FDA APIs Developed by Third Parties A. Estimate the costs of either:

• Moving the third party API into the openFDA environment for ongoing maintenance.

B. Linking the third party API with openFDA so that the outside user experiences it as part of openFDA. This is the preferred option. The third party would provide ongoing maintenance of their API. Performing the integration and updating all the relevant documentation.

Task 5: Regarding measures of the costs of developing new APIs, harmonizing the APIs, linking with outside APIs, and ongoing maintenance of each API:

A. With the rest of the openFDA team, develop the measures.

B. Implement the measures.

- 7 -

Task 6: Maintain the base openFDA cloud account that houses openFDA.

A. Provide documentation which describes how cloud account information is managed, including the roles of the Contractor employees who have access to the account.

B. Assist openFDA authorized users obtain and maintain cloud accounts.

Task 7: Move openFDA from one platform to another A. Move within the same vendor-provided cloud using open source technology, such as Docker, which has been used in openFDA to maximize portability.

B. Ensure no disruption to users, test and deploy openFDA on the new platform, and update all the relevant documentation.

Task 8: Move openFDA from the platform of a vendor-provided cloud to a similar platform

A. Move in a cloud provided by a different vendor using open source technology, such as Docker which has been used to maximize portability.

Task 9: Move openFDA from the platform of a vendor-provided cloud to a different platform

A. Move in a cloud provided by a different vendor using open source technology, such as Docker which has been used to maximize portability.

2.5 LABOR CATEGORY DESCRIPTIONS

Product Manager.

Experience: A preference of approximately 10 years of IT or telecommunications experience, including at least 5 years of IT software management experience. Also must have at least 5 years of experience in direct supervision of IT software development (including agile project management methodology), experience with health data standards (i.e HL7) integration maintenance projects, and/or telecommunications management.

Duties: Performs day-to-day agile project management of assigned delivery order projects that involve teams of data processing and other information system and management professionals who have previously been involved in analyzing, designing, integrating, testing, documenting, converting, extending, and implementing automated information and telecommunications systems. Demonstrates proven skills in those technical areas addressed by the delivery order to be managed. Organizes, directs, and coordinates the planning and production of all activities associated with assigned delivery order projects. Demonstrates writing and oral communication skills.

- 8 -

Technical Writer/ Editor and Communication Specialist Experience: A preference of approximately 5 years of experience as a technical writer with 2 years of experience in editing documents, including technical documents, written by others.

Duties: Assists in collecting and organizing information for preparation of user manuals, training materials, installation guides, proposals, and reports. Edits functional descriptions, system specifications, user manuals, special reports, and any other customer deliverables and documents. Assists in performing financial and administrative functions.

Must demonstrate the ability to work independently or under only general direction.

Data Scientist Experience: A preference of approximately 5 years of experience in large-scale data analysis and consumption, including extensive experience in data cleaning and harmonization with 2 years of experience in the domains of therapeutic, food, or tobacco products is preferred, as is an understanding of data standards in use by FDA (e.g., ICSR, HL7, NDC, ISO, etc.). Demonstrated background in user-engagement and agile development, with concrete examples of working with both internal and external customers to locate and analyze data in order to derive new insights. Experience in developing/writing openly released code for public consumption. Experience in designing and developing big data implementations using full-text search technologies (such as Solr and ElasticSearch) and unstructured text analysis/Natural Language Processing.

Duties: Using agile methodology designs and develops big data implementations utilizing full-text search technologies (such as Solr and ElasticSearch) and unstructured text analysis/Natural Language Processing. Engage users. Work with both internal and external customers to locate and analyze data in order to derive new insights. Develop and write openly released code for public consumption.

Data Engineer Experience: A preference of approximately 5 years of experience in large-scale data analysis and consumption, including extensive experience in data cleaning and harmonization. Also prefer extensive experience with full-text search technologies such as Solr and ElasticSearch in a production setting. Web architecture skills (especially with cloud technologies) in a Linux environment is preferred. Individual has demonstrated comfort with managing the entire stack of operations, from configuration management and deployment (e.g., with Chef) to back-end and front-end development with python (e.g., luigi), node.js, HTML, and CSS. Individual has experience with agile development and writing openly released code for public consumption

Duties: Build, deploy and manage large-scale infrastructure used for data analysis. Uses full-text search technologies such as Solr and ElasticSearch in a production setting.

Engineers cloud technologies in a Linux environment. Manages the entire stack of

- 9 -operations, from configuration management and deployment (e.g., with Chef) to back-end and front-end development with python (e.g., luigi), node.js, HTML, and CSS. Uses agile development and writes openly released code for public consumption.

Usability Experience (UX) Designer Experience: A preference of approximately 5 years of experience as a web designer to include 2 years of experience in data visualization and responsive web design.

Experience with technologies that include python (e.g., luigi), node.js, HTML, CSS, JavaScript, and Jekyll. Specialized experience in data visualization and requisite technologies such as d3.js, Google Maps, ArcGIS, or other tools. Individual should have demonstrable experience in agile development and working with internal and external audiences to discover user needs and iterate designs based off user feedback. Experience with Responsive Web Design is valuable.

Duties: Designing and building web interfaces based off user engagement and feedback.

Use HTML, CSS, JavaScript, and Jekyll. Provide data visualization using technologies such as d3.js, Google Maps, ArcGIS, or other tools. Use agile development and work with internal and external audiences to discover user needs and iterate designs based off user feedback. Develop and use Responsive Web Design

Other Key Skills:

• Full-text search technologies (i.e Solr or ElasticSearch)

• Data Standard (ICSR, HL7, and NDC)

• Data formats (XML, CSV, JSON)

• Web Technologies (HTML, CSS, node.js, Python, and other open source technologies)

• Agile Software Development

• User-Centered Software Development

• User Interface/Experience Design

• Search and Analytics API Development/Architecture

• Technical communications (written, oral and training materials)

SECTION 3 - INSPECTION AND ACCEPTANCE

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

For the purpose of this PART, (COR –TBD) is the authorized representative of the Contracting Officer.

52.246-4 - Inspection of Services - Fixed-Price (AUG 1996) 52.246-6 - Inspection of Services – Time and Material and Labor Hour (MAY 2001)

- 10 -

SECTION 4 - DELIVERIES OR 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)

4.1 ANTICIPATED DELIVERABLES

Note: Actual deliverables and deliverable schedules shall be established in the issuance of each individual task order.

Periodic Progress Reports - The Contractor shall submit one (1) electronic copy of the Progress Report to the COR and Contracts Specialist. The report shall include a status update on each task worked on and deliverables submitted, any problems encountered, and suggestions for addressing problems each period. 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 will be required.

Interim Draft Work Product - The Contractor shall submit to the COR an Interim Draft Work Product. Comments on this report will be provided by FDA within fifteen (15) calendar days after receipt. The interim draft work product shall also include:

• A prototype, example, or draft of the work product specified in the task order. The prototype should include preliminary data validation.

• An indication of any current problems which may impede performance and proposed corrective action.

Draft Final Work Product - The Contractor shall submit to the COR a draft final work product, which will be after the completion and approval of FDA’s review of the interim draft work product. The contractor shall also submit, where applicable, PC-compatible raw data collected, software and computer programs for implementation of models, guidance to data and models, and in some instances a final report. Documentation to support datasets should include explanatory materials such as information about the data collection methods and sources, information about the structure of the dataset, complete list of variables, and full details of coding and classifications used as well as data validation. The Contractor shall be prepared to present results to FDA at this point. This draft final work product is subject to the review and approval of FDA. Such approval or disapproval, with any comments, will be provided by FDA within fifteen (15) calendar days after receipt. The draft final work product shall also include:

• An indication of any current problems which may impede performance and proposed corrective action.

- 11 -

• An outline of the work to be accomplished during the reporting period.

• A quantitative description of overall progress and how it relates to earlier work.

Final Work Product - The Contractor shall submit to the COR the final work product which incorporates a listing of accomplishments as it related to the listed tasks as well as recommended revisions and other changes. The Contractor shall also include a detailed account of data loaded into the cloud platform such as raw datasets and API’s created by FDA or the Contractor. Documentation to support the API’s and raw datasets shall include a complete list of variables, full details of open source coding and classification uses, and data validation.

The final guide shall include tables, graphs, diagrams, curves, sketches, photographs and drawings as necessary and in sufficient detail to comprehensively explain the creation and use of the work product or a written report.

4.2 ORDERING PERIOD

Task Orders may be issued up to the final day of this contract, and the contract shall remain in force to allow for the completion of all task orders issued. However, the Government shall not issue, and the Contractor shall not accept any new task orders issued subsequent to the performance period of this contract.

4.3 PERIOD OF PERFORMANCE

The period of performance for the base period of the contract shall be one (1) year from the effective date of the contract.

Base Year Dates TBD

4.4 OPTION PERIODS

Option PERIOD

Option Period One (1) One (1) year from the effective date of option award

Option Period Two (2) Two (2) years from the effective date of option award

Option Period Three (3) Three (3) years from the effective date of option award

Option Period Four (4) Four (4) years from the effective date of option award

SECTION 5 - CONTRACT ADMINISTRATION DATA

5.1 ORDERING PROCEDURES

Ordering services under this contract shall be accomplished by the issuance of written task orders specifying the services being ordered. All task orders issued under this

- 12 -contract shall conform to the provisions of the contract clause in Section 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.

TASK ORDER PROCESSING

All task orders issued hereunder are subject to the terms and conditions of this contract. This contract shall control in the event of conflict with any task order.

A task orders shall be “issued” for purposes of this contract upon the effective date of the order.

The general process for individual task orders is as follows:

a) The FDA will prepare a statement of work. The SOW will include, at a minimum, the following elements:

1. Description of work in terms of the purpose or objectives of the work to be performed.

2. Description of how the work performance is assessed relative to objectives, goals, and outcomes.

3. Period and place of performance

4. Reporting requirements and Deliverables

5. Whether the order will be fixed price, labor hour, time and material or a hybrid type task order

b) Requests for Task Order Proposals (RTOPs) shall only be issued by the

Contracting Officer.

c) 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 RTOP 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.

The Government shall evaluate task order proposals for technical acceptability and price reasonableness.

5.2 CONTRACTING OFFICERS REPRESENTATIVE (COR)

The following COR will represent the Government for the purpose of this contract: (To Be Determined Upon Contract Award)

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4)

- 13 -performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

5.3 CONTRACTING OFFICER (CO)

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in a task order; (2) modify or extend the period of performance;

(3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

The contact information for the Contracting Officer is:

Sean Wybenga 5630 Fishers Lane Rockville, MD 20857 Sean.Wybenga@fda.hhs.gov;

Tel: (240) 402-7629; Fax: (301) 827-7106

The contact information for the Contract Specialist is:

Lisa Yaw 5630 Fishers Lane Rockville, MD 20857 Lisa.Yaw@fda.hhs.gov;

Tel: (240) 402-4018; Fax: (301) 827-7106

The contact information for the Ombudsman is:

Glenda Barfell Glenda.Barfell@fda.hhs.gov Tel: (301) 827-7042; Fax: (301) 827-7106

5.4 INVOICE SUBMISSION

A. The contractor shall submit all invoices to all addresses in the manner specified below:

(I) One original to the Contracting Specialist:

U.S. Food and Drug Administration Office of Acquisition and Grants Services ATTN: Lisa Yaw, Contracting Specialist 5630 Fishers Lane Room 2054 Rockville, MD 20857

Email: Lisa.Yaw@fda.hhs.gov

****Acceptable methods of delivery include: mail, hand delivery and email***** mailto:Sean.Wybenga@fda.hhs.gov mailto:Sean.Wybenga@fda.hhs.gov mailto:Glenda.Barfell@fda.hhs.gov

- 14 -

(II) One copy to the Contracting Officer‘s Representative (COR), clearly marked “Courtesy Copy Only”:

U.S. Food and Drug Administration

ATTN: (TBD); COR

Address:TBD Email: TBD@fda.hhs.gov

*****Acceptable methods of delivery include: mail, hand delivery and email*****

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 – Central Contractor Registration) and/or applicable Far Clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(I) Name and address of the contractor;

(II) Invoice Date and Invoice Number;

(III) Purchase order/Award Number;

(IV) Description, Quantity, Unit of Measure, Unit Price, and Extended Price Supplies Delivered or Services Performed, including: (a) Period of Performance for which costs are claimed; (b) Itemized travel costs, including origin and destination; and (c) Any other supporting information necessary to clarify questionable expenditures;

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

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

(VII) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment) (VIII) Name, title and phone number of person to notify in event of defective invoice;

(IX) Taxpayer Identification Number (TIN);

(X) Electronic Funds Transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited;

(XI) Name and telephone number of the FDA Contracting Officer Representative (COR) or other program center/office point of contact, as referenced on the purchase order; and, (XII) Any other information or documentation required by the purchase order/award.

(XIII) Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) List of all invoices submitted to date under the subject award, including the following: 1) Invoice number, Amount and Date Submitted; 2) Corresponding payment amount and date received.

(b) Total amount of all payments received to date under the subject contract or order.

(c) And, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current active period of performance.

mailto:XXXXX@fda.hhs.gov

- 15 -

C. An electronic invoice is acceptable if submitted in Adobe Acrobat (PDF) Format. All items listed in (I) through (XII) of this clause must be included in the electronic invoice.

Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

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

Office of Financial Services Food and Drug Administration W032- Second Floor

MAIL HUB 2145

10903 New Hampshire Avenue Bldg 32, Rm# 2162, Mail Hub 2145 Silver Spring MD 20993-0002 Attn: Vendor Payments

(301) 827-3742 or (866) 807-3742 fdavendorpaymentsteam@fda.gov

Final payments will occur upon verification by FDA COR and the FDA Technical Advisor, noting successful completion of each task. Payment will be made after acceptance and receipt of a proper invoice, and in accordance with the pricing matrix described in the Pricing Terms. Payment will be made on a task order basis.

5.5 KEY PERSONNEL

Key personnel will be specified in the calls issued and will be considered essential to the work to be performed hereunder. Prior to diverting any of the specified individuals to other programs, the Contractor shall notify the Contracting Officer reasonably in advance and shall submit justification (including proposed substitutions) in sufficient detail to permit evaluation of the impact on the program. No diversion shall be made by the Contractor without the written consent of the Contracting Officer; provided, that the Contracting Officer may ratify in writing such diversion and such ratification shall constitute the consent of the Contracting Officer required by this RFP. The contract may be modified from time to time during the course of the contract to either add or delete personnel, as appropriate.

The following position(s) are considered to be essential to the work being performed hereunder:

To Be Identified within each Task Order

The Contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitutions, complete resumes for the proposed substitutes, and any additional information requested by the Contracting Officer. Proposed substitutes shall have mailto:fdavendorpaymentsteam@fda.gov

- 16 -comparable qualifications to those of the persons being replaced. The Contracting Officer will notify the Contractor within fifteen (15) calendar days after receipt of all required information of the decision on substitutions.

SECTION 6 - SPECIAL CONTRACT REQUIREMENTS

6.1 CONTRACTOR PERFORMANCE EVALUATION(S)

In accordance with Federal Acquisition Regulation (FAR) 42.15, FDA will complete annual and final contractor performance evaluations. Annual evaluations will be prepared to coincide with the anniversary date of the contract. Additional interim performance evaluations may be prepared at Contracting Officer discretion, as necessary.

Final performance evaluations will be completed upon contract expiration.

FDA will utilize the Contractor Performance Assessment Reporting System (CPARS) in order to execute annual and final contractor performance evaluations. CPARS is a secure Internet website located at http://www.cpars.csd.disa.mil/cparsmain.htm. FDA will register the contractor in CPARS upon receipt of the name and email address of two (2) individuals who will be responsible for serving as the Contractor’s primary and alternate CPARS contacts. Once FDA registers the contractor in CPARS, the Contractor will receive an automated CPARS email message which contains User IDs and instructions for creating a password.

Once a performance evaluation is issued, the Contractor’s primary and alternate CPARS contact will receive an email instructing them to logon to CPARS in order to review the performance evaluation. The Contractor has 30 days from the date of performance evaluation issuance in which to review the evaluation. If the Contractor is in agreement with the performance evaluation outcome, the evaluation becomes final. Should the Contractor be in disagreement with the performance evaluation outcome, rebuttal comments must be submitted via the CPARS within 30 days from date the evaluation was issued by FDA. Any disagreement between the Contracting Officer and the Contractor will be referred to a contracting official one level above the Contracting Officer, whose decision will be final.

Copies of each performance evaluation and contractor responses, if any, will be retained as part of the official contract file and will be used to support future award decisions.

Evaluations will also be stored for a 3 year period in the Past Performance Information Retrieval System (PPIRS) at www.ppirs.gov.

Contractors may obtain CPARS training material and register for on-line training at http://www.cpars.gov/allapps/cpcbtdlf.htm. There is no fee for registration or use of the

CPARS.

http://www.ppirs.gov/ http://www.cpars.gov/allapps/cpcbtdlf.htm

- 17 -

6.2 ACOUNTABILITY AND SECURITY

All Contractor and subcontractor employees who will have access to Government information and/or sensitive materials must sign a Confidentiality Agreement. It is the responsibility of the Contractor to assure that such Agreements have been signed before access is permitted. Copies of signed agreements should be provided to the Task Order

COR.

6.3 508 STANDARD REQUIREMENTS

Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, requires that all electronic and information technology (EIT) products and services developed, acquired, maintained, or used under this contract/order must comply with the “Electronic and Information Technology Accessibility Provisions” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194.

Information about Section 508 is available at http://www.section508.gov/. The complete text of Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards/section-508-standards.

The contractor is expected to use the existing FDA environment and tools which are already in compliance with 508 standard requirements.

6.4 SECURITY AND PRIVACY

Contractor personnel performing work under this contract shall satisfy all requirements for appropriate security eligibility in dealing with access to sensitive information and information systems. Personnel assigned to this contract shall be required to complete and undergo a National Agency Check Inquiry (NACI) before the contractor employee may be issued an identification badge as well as bill to the contract (not prior to assignment). Unfavorable information security check results will be reported to GSA and appropriate action taken.

Because of the sensitivity of much of the FDA data, contractor staff shall also be required to undergo a Level 5 Public Trust security clearance, including finger printing, performed under the auspices of the FDA.

The contractor agrees that contractor personnel will not divulge or release data or information developed or obtained in connection with the performance of the resulting contract, unless made public by FDA or upon written approval of the Government.

Except as may otherwise be permitted by a data owner, the contractor personnel agrees not to use, disclose or reproduce proprietary data, other than as required in performance of the contact; provided, however, that nothing herein shall be construed as precluding the use of any data independently acquired by the contractor without such limitation.

Due to the sensitive nature of the information involved, all contractor personnel will be required to sign a non-disclosure agreement before data and information otherwise http://www.section508.gov/ http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards/section-508-standards http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards/section-508-standards http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards/section-508-standards

- 18 -exempt from public disclosure (e.g. Privacy Act or Data Collected Under an assurance of Confidentiality) may be disclosed to them.

The contractor shall submit a roster, by name, position and responsibility, of all staff (including subcontractor staff) working under the task order that will develop, have the ability to access, or host and/or maintain a Federal information system(s). The roster shall be submitted to the Project Officer, with a copy to the Contracting Officer, within 14 calendar days of the effective date of the task order. Any revisions to the roster as a result of staffing changes shall be submitted within 15 calendar days of the change.

HHS policy requires contractors/subcontractors receive security training commensurate with their responsibilities for performing work under the terms and conditions of their contractual agreements. The contractor shall ensure that each contractor/subcontractor employee has completed the FDA Computer Security Awareness Training course prior to performing any contract work and thereafter annually during the period of performance of the contract. HHS may change, add or modify Computer Security Awareness training requirements to enhance the HHS computer security program.

Each contractor/subcontractor employee who may have access to non-public Department information under this contract shall complete and submit the FDA Form 3398:

Contractor’s Commitment to Protect Non-Public Information (NPI) Agreement available upon request from the FDA Intranet site. A copy of each signed and witnessed Non- Disclosure agreement shall be submitted to the Project Officer or designee prior to performing any work under the contract. The Project officer or designee will inform the contractor of any additional forms and training that are required.

6.5 TRAVEL AND PER DIEM

Travel and Per Diem authorized under this contract shall be reimbursed in accordance with the Federal Travel Regulations currently in effect. Per Diem rates shall not exceed the Government approved rates in effect (http://www.gsa.gov/portal/category/21287).

Travel requirements under this contract shall be met using the most economical form of transportation available. If economy class transportation is not available, the request for payment voucher must be submitted with justification for use of higher class travel indicating dates, times, and flight numbers.

The COR must review and approve all travel requests prior to actual travel.

6.6 GOVERNEMNT PROPERTY

52.245-1 Government Property (APR 2012)

Government Furnished Equipment (GFE) includes a networked PC installed with the FDA standard software for all contract personnel performing work on the FDA network or hosted environment. Government Furnished Information (GFI), including Standard Operating Procedures, enterprise architecture standards, and other supplemental document will be provided to offeror upon award.

http://www.gsa.gov/portal/category/21287

- 19 -

SECTION 7 - CONTRACT CLAUSES

7.1 HHSAR CLAUSES INCORPORTATED BY REFERENCE

This contract incorporates one or more clauses by reference with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at:

http://www.hhs.gov/policies/hhsar/subpart301-1.html.

352.201-70, PAPERWORK REDUCTION ACT (JAN 2006)

352.202-1, DEFINITIONS (JAN 2006)

352.203-70, ANTI-LOBBYING (JAN 2006)

352.215-70, LATE PROPOSALS AND REVISIONS (JAN 2006)

352.222-70, CONTRACTOR COOPERATION IN EQUAL EMPLOYMENT

OPPORTUNITY INVESTIGATIONS (JAN 2010)

352.223-70, SAFETY AND HEALTH (JAN 2006)

352.224-70, PRIVACY ACT (JAN 2006)

352.227-70, PUBLICATIONS AND PUBLICITY (JAN 2006)

352.239-73, ELECTRONIC INFORMATION AND TECHNOLOGY ACCESSIBILITY

(JAN 2010)

352.242-70 KEY PERSONNEL (JAN 2006)

352.242-71, TOBACCO-FREE FACILITIES (JAN 2006)

352.242-73, WITHHOLDING OF CONTRACT PAYMENTS (JAN 2006)

352.270-10 ANTI-LOBBYING (JAN 2006)

7.2 52.252-2 FAR CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at:

www.acquisition.gov/far/index.html.

http://www.hhs.gov/policies/hhsar/subpart301-1.html http://www.acquisition.gov/far/index.html

- 20 -

52.212-4, CONTRACT TERMS AND CONDITIONS—COMERCIAL ITEMS (FEB

2012) ALTERNATE I (AUG 2012)

52.216-7, ALLOWABLE COST AND PAYMENT (JUN 2011)

52.227-17, RIGHTS IN DATA – SPECIAL WORKS (DEC 2007)

52.232-40, PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS

SUBCONTRACTORS (DEC 2013)

7.3 FAR CLAUSES BY FULL TEXT

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO

IMPLEMENT STATUTES OF EXECUTIVE ORDERS—COMMERCIAL ITEMS

(DEC 2015)

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

(1) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015)

(2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77, 108-78 (19 U.S.C. 3805 note)).

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

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

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

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub L. 111-5) (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009).

X (4) 52.204-10, Reporting Executive compensation and First-Tier Subcontract Awards (Oct 2015) (Pub. L. 109-282) (31 U.S.C. 6101 note).

- 21 -

___ (5) [Reserved]

___ (6) 52.204-14, Service Contract Reporting Requirements (Jan 2014) (Pub. L.

111-117, section 743 of Div. C).

___ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Jan 2014) (Pub. L. 111-117, section 743 of Div. C).

X (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Oct 2015) (31 U.S.C.

6101 note).

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

___ (10) [Reserved]

___ (11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a).

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

___ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C. 657a).

___ (ii) Alternate I (Jan 2011) of 52.219-4.

___ (13) [Reserved]

X (14) (i) 52.219-6, Notice of Total Small Business Aside (Nov 2011) (15 U.S.C.

644).

___ (ii) Alternate I (Nov 2011).

___ (iii) Alternate II (Nov 2011).

___ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).

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

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

___ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C.

637(d)(2) and (3)).

- 22 -

___ (17) (i) 52.219-9, Small Business Subcontracting Plan (Oct 2015) (15 U.S.C.

637 (d)(4)).

___ (ii) Alternate I (Oct 2001) of 52.219-9.

___ (iii) Alternate II (Oct 2001) of 52.219-9.

___ (iv) Alternate III (Oct 2015) of 52.219-9.

___ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).

X (19) 52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C.

637(a)(14)).

___ (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

___ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set- Aside (Nov 2011) (15 U.S.C. 657f).

X (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)).

___ (23) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women- Owned Small Business (EDWOSB) Concerns (Jul 2013) (15 U.S.C. 637(m)).

___ (24) 52.219-30, Notice of Set-Aside for Women-Owned Small Business (WOSB) Concerns Eligible Under the WOSB Program (Jul 2013) (15 U.S.C.

637(m)).

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

X (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2014) (E.O. 13126).

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

X (28) 52.222-26, Equal Opportunity (Apr 2015) (E.O. 11246).

X (29) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

X (30) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

X (31) 52.222-37, Employment Reports on Veterans (Oct 2015) (38 U.S.C. 4212).

- 23 -

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

X (33) (i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C.

chapter 78 and E.O. 13627).

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

X (34) 52.222-54, Employment Eligibility Verification (Oct 2015). (E. O. 12989).

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

___ (35) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

___ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

___ (36) (i) 52.223-13, Acquisition of EPEAT® -Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514

___ (ii) Alternate I (Oct 2015) of 52.223-13.

___ (37) (i) 52.223-14, Acquisition of EPEAT® -Registered Television (Jun 2014) (E.O.s 13423 and 13514).

___ (ii) Alternate I (Jun 2014) of 52.223-14.

___ (38) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007)…