Sentinel_2014_RFP_Amendment_1.doc

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RFP #FDA-14-RFP-1127332

Sentinel 2014-Amendment 1

Section B-SUPPLIES OR SERVICES AND PRICE/COSTS

B.1 Type of Contract The Government contemplates a single award of a Hybrid Firm Fixed Price/Labor Hour Indefinite Delivery Indefinite Quantity contract vehicle for five years, One (1) Base Year and Four (4) Option Years.

B.2 Background The Food and Drug Administration Amendments Act of 2007 (FDAAA) requires the Food and Drug Administration (FDA) to collaborate with public, academic, and private entities to develop methods for obtaining access to disparate data sources and to validate means of linking and analyzing safety data from multiple sources. In light of this mandate, FDA launched the Sentinel Initiative, a long-term effort to create a national electronic system for monitoring the safety of FDA-regulated medical products. The Sentinel System, the end product of the Sentinel Initiative, shall expand FDA’s existing post-market surveillance capabilities by enabling FDA to actively gather information about the safety and performance of its regulated medical products once they reach the market.

To develop the data infrastructure and scientific operations needed for the Sentinel System, FDA initiated specific projects, including a pilot system, Mini-Sentinel. The Mini-Sentinel pilot allows FDA the opportunity to develop and pilot the data infrastructure and scientific operations needed to conduct active surveillance of medical products within a distributed system. To date, the Mini-Sentinel pilot has enabled FDA to query privately held electronic healthcare data, including administrative and claims data from health plans covering more than 153 million lives and clinical data for more than 25 million members. Information about Mini-Sentinel is available at: http://www.mini-sentinel.org/.

The Sentinel Initiative is providing an opportunity for the broad medical and scientific communities to partner in the establishment of a foundation for future secondary uses of electronic healthcare data (e.g., electronic health records, clinical, administrative and claims databases). Opportunities exist for the Sentinel System’s data infrastructure to be accessible to various stakeholders, both in the government and private sectors, providing maximal value to the broad public health. FDA is collaborating with other government agencies and the private sector to make this vision a reality, with the goal of achieving economies of scale, reducing duplication of efforts, and leveraging available human and financial resources. This type of collaboration is critical.

It is essential that the developed Sentinel System be implemented in a way that guarantees the integrity of FDA’s regulatory and statutory mandates and that the privacy and security of personally identifiable information and other proprietary information remain safeguarded.

B.3 Minimum and Maximum Ordering Amounts

The contract minimum amount will be award of the base contract.

The contract maximum amount for the IDIQ is estimated at $150,000,000.00 over five years.

B.4 Prices/Costs

The pricing schedules are as follows:

Firm Fixed Price

Base Year

CLIN

Option Year One

CLIN

Option Year Two

CLIN

Option Year Three

CLIN

Option Year Four

CLIN

Loaded Hourly Rates

Rates

Specialist

Specialist II

Specialist III

B.5 Travel Regulations Any required travel by the Contractor will be at the direction of the Government and will be reimbursed at cost in accordance with the Federal Travel Regulations (FTR).

Area of Travel – Performance under this contract may require travel by Contractor personnel. If travel, domestic or overseas, is required, the Contractor is responsible for making all needed arrangements for Contractor’s personnel. This includes but is not limited to the following:

· Medical Examinations

· Immunizations

· Passports

· Visas, etc.

· Security Clearances

Travel Policy – The Government will reimburse the Contractor for allowable travel costs incurred by the Contractor in performance of the contract and determined to be in accordance with FAR subpart 31.2, subject to the following provisions: Travel required for tasks assigned under this contract shall be governed in accordance with rules set forth for temporary duty travel in FAR 31.205-46.

SECTION C-STATEMENT OF WORK/SPECIFICATIONS

C.1 Project Objectives The objectives of this contract are:

1. to provide the necessary resources and support to establish a single Coordinating Center that enables active medical product surveillance by FDA using a distributed data model that leverages electronic healthcare data, including activities such as methods development

2. to further develop a distributed data infrastructure utilizing the Mini-Sentinel Common Data Model (MSCDM) and a distributed network governance that shall enable active medical product surveillance, including near real-time assessment of medical products used during public health emergencies, and could also be leveraged for different types of activities to include: medical product and comparative effectiveness research, biomedical research, public health surveillance and quality of care.

C.2. Coordinating Center Activities (base award) The Contractor shall establish and maintain throughout the contract (base year and option years one through four), a single Coordinating Center, the Sentinel Coordinating Center (SCC) that enables active medical product surveillance using a distributed data model. The responsibilities of the Coordinating Center are to establish and maintain technical expertise in pharmacoepidemiology and biostatistics for identifying, developing, validating, enhancing and implementing advanced analytical and statistical methods related to medical product surveillance to address the specific issues, challenges and objectives outlined for each task. In addition, this would require demonstrated expertise in implementing standardized data elements and conducting evaluations using disparate electronic healthcare data systems. Whenever possible, the contractor shall leverage the infrastructure and resources developed during the FDA’s Mini-Sentinel Pilot.

The SCC shall develop, implement, maintain and expand the infrastructure required to support all task order functions and activities related to workgroups for the duration of the period of performance. The SCC shall provide the following functions to facilitate the development and use of the Sentinel System:

1. Create a Coordinating Center governance structure that shall allow for the development of policies, procedures, and processes that ensure scientific rigor, data integrity, and protection of privacy. Specific requirements include:

· Creation of a board to ensure multi-stakeholder representation in the creation and implementation of the governance structure.

· Creation of policies and procedures related to uses of data, privacy, communications, confidentiality, conflict of interest, intellectual property, and other relevant topics. These processes shall have to ensure compliance with all relevant federal laws and regulations, including Health Insurance Portability and Accountability Act (HIPAA) , Federal Information Security Management Act (FISMA) and any applicable state and local laws.

2. Provide training, as appropriate, to FDA staff on methods and tools employed in carrying out identified tasks. The type of training shall be determined by the tools or methods developed, but could include development of training manuals, conduct of training sessions, or other methods deemed appropriate.

3. Create the organizational structure and administrative processes for the Coordinating Center that support active medical product surveillance.

4. Ensure secure communication among the consortium of participating data environments to enable coordination of specific active medical products surveillance queries.

5. Create and maintain a public website for transparent information sharing and a secure web based infrastructure for file sharing and resource library.

6. Coordinate with FDA and external stakeholders (e.g., Office of the National Coordinator for Health Information Technology (ONC)) to ensure contract activities conform to current national data standardization guidelines and rules.

7. Engage with investigators from other surveillance-related initiatives (e.g., Innovation in Medical Evidence Development and Surveillance Program (IMEDS), Vaccine Safety Datalink (VSD), and FDA-sponsored post marketing epidemiologic contracts) to ensure contract activities leverage the ongoing work and lessons learned.

The following specific activities shall be conducted to as a part of the base award of this contract.

C.2.1. Develop and Implement the SCC Workplan

The workplan shall define all tasks and associated deliverables for establishing and maintain the SCC. C.2.2. Create a Statement of Principles and Operating Policies

A comprehensive Statement of Principles and Operating Policies document shall be created to serve as a basis for the conduct of Sentinel activities. The contractor should use as a reference the Principles and Policies document developed during the FDA’s Mini-Sentinel Pilot as a starting point.

The document shall adhere to the contractual agreements of this project. In addition to principles and policies, it shall include an organizational model, descriptions of roles and responsibilities, and any needed processes to implement policies. Continued revisions and development of policies and processes to support principles shall be ongoing, as needed.

C.2.3. Convene and Staff Organizational Units

The SCC shall identify the needed organizational groups to support the work of the SCC. The model used by Mini-Sentinel should be considered, which included a Planning Board, Safety Science Committee, and workgroups such as the Data, Methods, and Protocol Cores and a Privacy Panel, but is not required. However, representation from a broad group of stakeholders, including those whose data shall be accessed for surveillance purposes, should be included in at least one of the identified groups.

C.2.4. Identify and Create Sentinel Administrative Templates

To enhance efficiencies and increase deliverables of Sentinel activities, re-usable administrative templates (e.g., data use agreements, budgeting, scheduling, project management) shall be created and disseminated to participating organizations.

C.2.5. Sentinel Website and Web-Based Infrastructure

C.2.5.1 Create and maintain the Sentinel public website

The Contractor shall develop and maintain the Sentinel public website. The public website shall be established to ensure transparency, provide general project information and status reports, and policies and procedures. All deliverables from this contract and any of its task orders shall be posted on the website. The website shall comply with Section 508 of the Rehabilitation Act.

C.2.5.2. Create and maintain a secure web-based infrastructure for file sharing

Create and implement secure data transfer capabilities to allow secure file sharing and document storage, in accordance with all federal security guidelines, policies, and mandates. The system shall comply with the requirements and standards of FISMA, HIPAA, and the National Institute of Standards and Technology (NIST)

C.2.5.3 Establish web-based resource library

Develop and establish a Sentinel resource library. The library shall be a web-based searchable catalog of all contract deliverables and other relevant information. The library shall be maintained and updated by the SCC to ensure information is correct, timely and transparent. Items for inclusion include: programs for common tasks (e.g., identify concomitant drug exposure, continuous health plan eligibility, and defining outcomes) and detail project specifications. Items for inclusion that may be found in the public domain: external code (e.g., risk score algorithms), relevant publications on statistical and epidemiologic methods, and validated outcome definitions.

Library resources shall be made available on the public website. However, information deemed confidential shall be housed within the secure website and available only to authorized users as per applicable federal privacy and security laws, regulations and policies.

C.2.6. Training Programs for FDA Staff

C.2.6.1. Training seminars for FDA staff

Develop and coordinate a monthly seminar series for FDA staff. The purpose of the seminar series is to disseminate information to FDA staff on Sentinel activities and deliverables. Seminars shall be 1.5-2 hours in length, and occur monthly. Topics shall be developed in conjunction with FDA. Seminar leaders shall ordinarily lead the seminars using remote technology (e.g., webinars).

C.2.6.2 FDA medical product center staff training

The SCC shall send one or more staff members to work with surveillance and new product review staff at each of FDA’s medical product centers not more often than for two complete working days quarterly. The purpose of these interactions is for Sentinel staff to become familiar with processes and analytic procedures and to see how Sentinel work interfaces with non-Sentinel efforts. This shall also promote communication between FDA users and the Sentinel contract team.

C.2.6.3. Training activities at the SCC

FDA staff may choose to work at the SCC to allow in depth collaboration and familiarization with Sentinel capabilities and operations. The length of these work assignments can be adjusted to the needs and availability of FDA personnel. The SCC can host one FDA staff member at a time.

C.2.7. Sentinel Query Log

The SCC shall establish a log to document issues arising with executed queries, their resolution, and lessons learned (upon completion with results shared by all Data Partners), improve tracking and enable searches. The log shall also list the purpose of each query and serve as documentation for FDA and the SCC. This log shall be used for future planning.

C.3

TASK ORDER ACTIVITIES

Individual task orders shall require the Contractor to access and utilize data from disparate electronic healthcare data systems for active medical product surveillance. The following are areas under which a task order may be issued.

C.3.1 Surveillance Activities The FDA is aware that there are various methods of collecting healthcare data. It is FDA’s intention to leverage any existing method of surveillance to meet FDA’s requirements

Specific tasks that could be order include, but are not limited to:

1. Collaborate with FDA to identify, prioritize and evaluate potential medical product-event pairs for surveillance which requires the Contractor to have and maintain the ability to do the following throughout the duration of the contract:

· Identify queries that shall be appropriate to answer important questions related to a given medical product safety topic;

· Form groups (i.e., cohorts) of patients exposed to one or more medical product and to follow them from the occurrence of one or more medical outcomes;

· Derive measures of therapeutic use, prescription drug consumption, exposure and utilization using electronic healthcare data systems and epidemiologic techniques;

· Access and use drug information resources and compendia;

· Develop algorithms for identifying possible health outcomes of interest using national standard coding systems including, but not limited to, the International Classification of Diseases (e.g., ICD-9-CM, ICD-10-CM) and clinical procedure coding (e.g., CPT codes);

· Provide a description of the processes used for quality assurance and quality control of all electronic healthcare data systems and analyses used for projects with the Agency.

2. Develop protocol-based surveillance plans and study designs that utilize pharmacoepidemiological and biostatistical principles and methods.

3. Enhance and utilize a semi-automated prospective surveillance system which shall perform routine, near real-time, surveillance of newly approved medical products as well as evaluate other post-market medical issues for products already on the market.

4. Develop and implement capability (i.e., standardized tools) to conduct rapid response surveillance queries, including queries related to the use of medical products during public health emergencies, and routine active surveillance in the distributed database.

C.3.2 Data Infrastructure

The FDA are aware of various efforts ongoing to develop resources that would allow the use of electronic healthcare data for evidence development, including medical product surveillance, it is FDA’s intention to leverage any existing infrastructure that could meet FDA’s requirements. If a national resource for secondary use is not available that suits FDA’s needs, then the following areas may be undertaken.

1. Create a data infrastructure governance to address data specific issues and the interaction between the SCC and the Data Partners, including, for example, policies, procedures, and processes that ensure scientific rigor, data integrity, and protection of privacy.

2. Create a data infrastructure that uses a distributed data approach in which Data Partners maintain physical and operational control over electronic data in their existing environments (i.e., behind their respective firewalls) that allows analyses through the use of the a common data model (e.g., the Mini-Sentinel Common Data Model (MSCDM)) to standardize administrative and clinical information across Data Partners. Data Partners shall execute standardized programs (i.e., data queries) distributed by the SCC.

3. Maintain and enhance current/latest version of common data model (CDM)utilizing nationally recognized data standards and controlled terminologies, including those proposed by ONC

4. Coordinate and oversee development and implementation of the distributed data approach enabling secure communications between data partners, SCC and FDA.

5. Ensure data in the distributed-CDM format is available for the SCC to run analytical/modular programs used for generating aggregated analytical data files from patient-level files that remain with data partners and regularly refreshed at specified intervals (this could be as frequently as weekly for some data elements) and assessed and evaluated so as to maintain data quality and provide characterization of data following extract, transform, and load (ETL) process

6. Create ability for simple and rapid menu-driven querying of pre-populated summary tables which contain counts based on CDM in identified elements.

7. Ensure participation of multiple data partners that have data available that represent at least 100 million patients with the ability to access medical records for most of those patients.

C.3.3 National Infrastructure

This activity would support broader access to the data infrastructure by those outside of FDA for different types of activities (e.g., medical product safety and effectiveness, comparative effectiveness research, biomedical research, public health surveillance and quality of care).

1. Expand governance developed to include creation of policies and procedures related to uses of data, prioritization of resources (with an emphasis on FDA inquiries taking priority over that of other uses), privacy, communications, confidentiality, conflict of interest, intellectual property, IRB review (when applicable), and other relevant topics

2. Develop processes that comply with all relevant federal laws and regulations, including HIPAA, FISMA and any applicable state and local laws.

3. Participate with the data partners contributing to Data Infrastructure to develop a national data resource that would leverage its data for FDA medical safety surveillance purposes, at a minimum. Consider access by other users (e.g., other government agencies, academia, medical product developers) for other purposes (e.g., medical product and comparative effectiveness research, biomedical research, public health surveillance, or quality of care measurements), in accordance with the agreed upon governance structure.

C.3.3 Methods Development

This activity would conduct work on priorities identified by the FDA to support medical product surveillance activities.

1. Advance methodological research and development (e.g., developing new methods for use, evaluating performance of new and existing methods, and applying new and existing methods within a distributed data system).

2. Develop surveillance plans and study designs

3. Develop and apply pharmacoepidiemiological and biostatistical principles and methods

4. Develop, apply and evaluate advanced statistical approaches to safety signal detection, signal refinement, and signal validation in electronic healthcare data sources for regulated medical products during the postmarketing period and unapproved medical products used under an Emergency Use Authorization EUA

5. Train on methods and tools employed in carrying out identified tasks (e.g., development of training manuals, conduct of training sessions).

SECTION D –PACKAGING AND MARKING

D.1 Packaging and Marking

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. As appropriate, note on the face page of the report and when feasible on the binding: (1) “one volume only” or (2) “volume 1 of 2.

SECTION E-INSPECTION AND ACCEPTANCE

E.1 Inspection and Acceptance a.

The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

b.

The Contracting Officer’s Representative is the duly authorized representative of the Contracting Officer and is responsible for inspection and acceptance of all items to be delivered under this contract.

c.

Inspection and acceptance of the Contractor’s performance shall be in accordance with the applicable FAR clauses in item d. below.

d.

This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.

52.246-4 Inspection of Services-Fixed Price

AUG 1996

52.246-6 Inspection-Time and Material and Labor Hour MAY 2001

SECTION F-DELIVERIES OR PERFORMANCE

F.1 Deliverables

Base Year

· Finalize SCC workplan

· Implementation of SCC workplan

· Identify areas of document which require updating

· Final document

· Identification of needed policies for development

· Finalize policies

Update as needed (at least twice) throughout the Period of Performance.

· Identification of organizational structure

· Routine meetings scheduled

· Routine meetings

· Identify needed templates

· Schedule for creation of templates

· Draft templates

· Finalize Templates

· Develop workplan and implementation specifications for launching and maintaining the Sentinel website

· Develop workplan, implementation specifications, and launch

· Yearly FISMA audits completed and reports submitted to the FDA

· Develop workplan, implementation specifications, and launch

· Post all contract deliverables with accompanying instructions in resource library

· Identify 10 to 12 training topics and format (tutorial papers, seminars, etc.) for training

· Prepare schedule for monthly 1.5-2 hour seminars and workshops

· Create and implement log integrated with query tool

· Post lessons learned within 10 days of query execution: throughout the performance period

· Enhance the query log to improve tracking:

Option Year 1

· Finalize SCC workplan

· Identify areas of document which require updating

· Final document

· Identification of organizational structure

· Identify needed templates

· Schedule for creation of templates

· Maintain and implement log integrated with query tool

· Post lessons learned within 10 days of query execution

· Enhance the query log to improve tracking

Option Year 2

· Finalize SCC workplan

· Identify areas of document which require updating

· Final document

· Identification of organizational structure

· Identify needed templates

· Schedule for creation of templates

· Maintain and implement log integrated with query tool

Option Year 3

· Finalize SCC workplan

· Identify areas of document which require updating

· Final document

· Identification of organizational structure

· Identify needed templates

· Schedule for creation of templates

· Maintain and implement log integrated with query tool

· Post lessons learned within 10 days of query execution

· Enhance the query log to improve tracking

Option Year 4

· Finalize SCC workplan

· Identify areas of document which require updating

· Final document

· Identification of organizational structure

· Identify needed templates

· Schedule for creation of templates

· Yearly FISMA audits completed and reports submitted to the FDA

· Post all contract deliverables with accompanying instructions in resource library

· Maintain and implement log integrated with query tool

F.2 Delivery Instructions for Reports

The contractor shall provide to the COR and the Contracting Officer a monthly status report in an electronic format within one week after the end of the month being reported. The report format shall confirm to instructions on electronic reporting that FDA shall provide. A detailed status report shall be submitted each month.

Each report shall include work completed and current status on each of the task orders (i.e., by activity and deliverable), worked planned for the following month, issues to be addressed, project risks, and problems encountered including how such problems impact the schedule date of completion and levels of effort.

The Offeror should have the capabilities (e.g., software, secure portal) to electronically and efficiently track work orders and statuses deliverables, in real time, related to all contract/task orders activities. The Offeror should implement this tracking system so that FDA can access it as needed.

F.3 Period of Performance

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

F.4

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

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address: http://www.acquisition.gov/comp/far/index.html.

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15 Stop Work Order

AUG 1989

52.242-17 Government Delay of Work

APR 1984

SECTION G- CONTRACT ADMINSTRATION DATA

G.1 Ordering Processes and Procedures

Ordering services under this contract shall be accomplished by the issuance of written task orders specifying the types of services being ordered. All task orders issued under this contract shall conform to the provisions of the contract clause in Section I.3 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.

G.1.2 Task Order Procedures

The process for awarding tasks orders shall be as follows:

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

2. The Contractor shall prepare and submit a task proposal addressing all areas of the requirement. The Contractor shall submit the task proposal within the time period specified in the RFTOP and adhere to the ceiling rates established in the contract if applicable. The proposal shall include a brief description of the technical approach and a price build up. The price build up should include the labor categories to be utilized, the number of hours within each labor category, extended pricing for each labor category and a bottom line price/ceiling. No separate payment shall be made to the contractor for the cost to prepare, submit or negotiate a task order proposal.

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

4. Once the proposal is acceptable to the Government, the Contracting Office shall issue the task order.

5. Orders shall include the following:

a. Task Order Number

b. Date

c. Accounting Information

d. SOW

e. Price/Ceiling

f. Period of Performance

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

Any work that the Contractor undertakes prior to receiving a fully executed task order signed by the Contracting Officer is undertaken at risk.

G.2 Contracting Officers Representative (COR) The following COR will represent the Government for the purpose of this contract:

(To be Determined at Time of 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) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance. The Government may unilaterally change its COR designation.

G.3 Contract Specialist

The contact information for the Contracting Specialist are:

Tara Hobson

5630 Fishers Lane

Rockville, MD 20857

Tara.Hobson@fda.hhs.gov Phone: (240) 402-7586 Lacetta Bowman

5630 Fishers Lane

Rockville, MD 20857

Lacetta.Bowman@fda.hhs.gov

Phone: (240) 402-75-66 G.4 Contracting Officer

The contact information for the Contracting Officer is:

Department of Health and Human Services

Food & Drug Administration, OAGS

Attn: James Chestnut

5630 Fishers Lane

Rockville, MD 20857

Phone: (240) 402-7570 James.Chestnut@fda.hhs.gov

G.5 Contractor Point of Contact

The contact information for the Contractor Point of Contact:

(To be Determined at the Award of the Contract) Name:

Email:

Phone:

G.6 Key Personnel The contractor shall provide the names and resumes of the key personnel assigned to this contract. The individuals cited below are key personnel.

Name

Title CDER Portfolio Lead

CBER Portfolio Lead

Data Group Lead

Principal Investigator

Program Manager

Descriptions:

1. CDER Portfolio Lead - Principal liaison to CDER. Ensures appropriate initiation and progress of CDER activities other than modular programs and summary tables.

2. CBER Portfolio Lead - Principal liaison to CBER, including both PRISM and Blood SCaN. Ensures appropriate initiation and progress of CBER activities other than modular programs and summary tables.

3. Data Group Lead - Responsible for development and implementation of data services, including network and software design, fulfillment of modular programs, summary tables, and programming needs for workgroups.

4. Principal Investigator - Responsible for overall strategy and implementation, engaging with all network partners.

5. Program Manager – Responsible for overall management of the administrative and project management aspects of all program activities and workgroups.

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

G.7 Invoice Submission The Contractor shall submit all invoices to all addresses in the manner specified below:

(I) One original and one copy to the approving official:

U.S. Food and Drug Administration

Office of Acquisitions and Grants Services

ATTN: Tara Hobson, CO/CS

5630 Fishers Lane

Room 2115, HFA-500

Rockville, Maryland 20857

E-mail: Tara.Hobson@FDA.HHS.GOV *** Acceptable methods of delivery include: mail, hand delivery and email

(II) One copy to the contracting officer technical representative (COR) or other program center/office designee, clearly marked “courtesy copy only”:

U.S. Food and Drug Administration/CFSAN

ATTN: (To be Determined at the Time of Award) 10903 New Hampshire Avenue, Building 32 Silver Spring, MD 20993-0002 E-mail: @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 other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(I) Name and address of the contractor;

(II) Invoice date and Invoice Number;

(III) Purchase Order/Award Number;

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

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

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

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

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

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

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

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

(IX) Taxpayer Identification Number (TIN);

(X) Electronic funds transfer (EFT) Banking information, including routing transit number of the financial institution receiving payment 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 contract, as referenced on the purchase order;

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

(XIII) Contractor is X□ is not □ 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 invoices for the current, active period of performance

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

10903 New Hampshire Ave

WO32-Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002

Attn: Vendor Payments G.8 System for Award Management Registration In accordance with the with the Debt Collection Improvement Act of 1996, in order to be considered for an award of a Federal contract, the contractor must be registered in the System for Award Management (SAM), a free web site that encompasses the capabilities of the - Central Contractor Registry (CCR); Federal Agency Registration (Fedreg); Online Representations and Certifications Application (ORCA); Excluded Parties List System (EPLS); and the Catalog of Federal Domestic Assistance.

If a new Contractor, you will need only your personal information to create an account in SAM. If a Contractor with an active record in CCR, you will not need to establish a SAM account. The CCR record transfers to become the active SAM account.

(1) Definitions.

"Registered in the SAM database" means that-

(i) The Contractor has entered all mandatory information, including the DUNS number or the DUNS+4 number, into the SAM database;

(ii) The Contractor's CAGE code is in the SAM database; and

(iii) The Government has validated all mandatory data fields, to include validation of the Taxpayer Identification Number (TIN) with the Internal Revenue Service (IRS), and has marked the record "Active". The Contractor will be required to provide consent for TIN Attachment, Page 1 of 4 validation to the Government as a part of the SAM registration process.

"System for Award Management (SAM)" means the primary Government repository for prospective federal awardee information and the centralized Government system for certain contracting, grants, and other assistance related processes. It includes-

(i) Data collected from prospective federal awardees required for the conduct of business with the Government;

(ii) Prospective contractor submitted annual representations and certifications in accordance with FAR Subpart 4.12. [If unable to complete updated representations and certifications in SAM, the Contractor must complete a paper copy of their Representations and Certifications and submit it with their proposal]; and

(iii) The list of all parties suspended, proposed for debarment, debarred, declared ineligible, or excluded or disqualified under the nonprocurement common rule by agencies, Government corporations , or by the Government Accountability Office.

(2) The Contractor shall be registered in the SAM database prior to submitting an invoice and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from this solicitation. The SAM registration shall be for the same name and address identified on the contract, with its associated CAGE code and DUNS or DUNS+4. If indicated by the Government during performance, registration in an alternate system may be required in lieu of SAM.

If the Contractor does not have a DUNS number, it should contact Dun and Bradstreet directly to obtain one. A contractor may obtain a DUNS number-

(i) Via the internet at http://fedgov.dnb.com/webform or if the contractor does not have internet access, it may call Dun and Bradstreet at 1-866-705-5711 if located within the United States; or

(ii) If located outside the United States, by contacting the local Dun and Bradstreet office. The contractor should indicate that it is a contractor for a U.S. Government contract when contacting the local Dun and Bradstreet office.

(3) The Contractor is responsible for the accuracy and completeness of the data within the SAM database, and for any liability resulting from the Government's reliance on inaccurate or incomplete data. To remain registered in the SAM database after the initial registration, the Contractor is required to review and update on an annual basis from the date of initial registration or subsequent updates its information in the SAM database to ensure it is current, accurate and complete. Updating information in the SAM does not alter the terms and conditions of this contract and is not a substitute for a properly executed contractual document.

(4) Contractors may obtain information on registration and annual confirmation requirements via the SAM accessed through https://www.acquisition.gov or by calling 866-606-8220, or 334-206-7828 for international calls. If there is any difficulty in updating this record, contact the Federal Service Help Desk at www.fsd.gov or 866-606-8220 for SAM assistance. https://www.sam.gov/portal/public/SAM/

SECTION H-SPECIAL CONTRACT REQUIREMENTS

H.1 Health and Human Services Acquisition (HHSAR) Regulation by Reference

352.202-1