Sentinel Amendment 2.doc

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RFP #09-223-SOL-00112 Amendment 2 Efforts to Develop the Sentinel Initiative

Section B-SUPPLIES OR SERVICES AND PRICE/COSTS

B.1 Type of Contract The Government contemplates award of one single Indefinite Delivery Indefinite Quantity contract vehicle for five years, One (1) Base Year and Four (4) Option Years.

At the discretion of the Contracting Officer, the Government may use a variety of contract types under the task orders to include: Firm Fixed Price (FFP), Labor Hour, or a combination thereof.

Each Request Task Order Proposal (RTOP) issued under this contract will identify the Government’s determination of task order type.

B.2 Background

In May 2008, the Secretary of Health and Human Services and the FDA Commissioner announced the Sentinel Initiative. The Sentinel Initiative is a long-term effort by the Agency to create a national electronic system for monitoring product safety. The Sentinel Initiative is intended to augment the Agency’s existing post-market (primarily passive) safety surveillance systems and to allow the Agency to actively gather information about the post-market safety and performance of its regulated products.

As currently envisioned, the Sentinel Initiative will enable the Agency to capitalize on the capabilities of multiple, existing automated healthcare data systems (e.g. electronic health record systems, administrative claims databases, registries) to augment the Agency’s current surveillance capabilities. The Sentinel Initiative will enable queries of disparate data sources quickly and securely for relevant product safety information. Data will continue to be managed by its owners, and only data of organizations who agree to participate in this system will be included. Questions would be sent to appropriate, participating data sources, who in turn would, in accordance with existing privacy and security safeguards, evaluate their data and send results for Agency review.

The Sentinel Initiative is a response to various calls for this type of effort from the Department of Health and Human Services (DHHS) and the Congress. In September 2005, the HHS Secretary asked the Agency to expand its current system for monitoring medical product performance and to explore the possibility of working with multiple automated healthcare data systems to augment the Agency’s current capabilities of identifying and evaluating product safety information. The Secretary recommended that the Agency explore creating a public-private collaboration as a framework for such an effort, leveraging large, automated healthcare databases.

In 2006, the IOM issued a report, entitled The Future of Drug Safety—Promoting and Protecting the Health of the Public.

Among other suggestions, this IOM report recommended the Agency identify ways to access other health-related databases and create a public-private partnership to support safety studies.

In 2007, Congress enacted the Food and Drug Administration Amendments Act of 2007 (FDAAA). Section 905 of this statute calls for the HHS Secretary to develop methods to obtain access to disparate data sources and to establish an active post-market risk identification and analysis system that links and analyzes safety data from multiple sources. The law sets a goal of access to data from 25 million patients by July 1, 2010, and 100 million patients by July 1, 2012. The law also requires the Agency to work closely with partners from public, academic, and private entities. The Agency views its Sentinel Initiative as a mechanism through which some of the requirements mandated in this legislation can be carried out.

The Sentinel Initiative is a long-term effort that must proceed in stages. The initial stage of the Sentinel Initiative has allowed the Agency to further refine the requirements and develop the scope. The Agency has funded 8 contracts to support this initial stage.

In addition to this ongoing contractual work, there are many ongoing activities in the public and private sector that will inform the Sentinel Initiative. The Agency has hosted a series of meetings with various stakeholder groups, to include other federal agencies; data sources and environments; academics and experts; patient, consumer, and provider groups; and IT vendors. In addition, in December 2008 a public workshop was held to discuss the Sentinel Initiative with the following objectives:

· To provide an update on the current status of the Sentinel Initiative and allow for comment from all stakeholders

· To discuss potential governance models and their implications

· To discuss approaches to ensuring continued involvement of all stakeholders as the initiative evolves

The objective of this contract is not to create the Sentinel System, but to provide the necessary support to facilitate the development of the Sentinel Initiative and carry out mandates delineated in FDAAA, including, but not limited to, requirements in Section 905. This will be carried out via the development of specific tasks, as deemed necessary by the Agency, and outlined below in the Scope of Work.

The work carried out on individual tasks will provide specific deliverables. These would be integrated with what has been learned from ongoing contractual work, as well as with other ongoing activities in both the public and private sectors. These cumulative efforts will aid in further understanding the feasibility and utility of these data and methodologies, primarily for active medical product surveillance.

The FDA would seek to undertake new activities to develop the scientific operations needed for the Sentinel Initiative. Specifically, FDA aims to fund a single coordinating center with continuous access to automated healthcare data systems, which would have the following capabilities:

· Provide a "laboratory" for developing and evaluating scientific methodologies that might later be used in a fully-operational Sentinel Initiative.

· Offer the Agency the opportunity to evaluate safety issues in existing automated healthcare data system(s) and to learn more about some of the barriers and challenges, both internal and external.

The contractor that is awarded this contract may be excluded for future work on the Sentinel Initiative described in paragraph B.2, Background.

B.3 Placement of Task Orders When contractual services, associated materials are required under this contract to perform, the Government will issue a task order. The Contracting Officer (CO) will provide a written task order request document to the Contractor describing the task project. The Request Task Order Proposal against this contract will be placed in writing, by means of a written task order. The Contracting Officer or his/her designee is/are the only person(s) authorized to place orders.

Task Orders will be either firm fixed price or labor hours.

A. Authorized Ordering Activities:

The Contracting Officer of the FDA may place orders under this contract. Except as may be otherwise specifically stated therein, whenever the words, “Contracting Officer” are used in the schedule of this contract, they shall be deemed to mean the Contracting Officer of the ordering activity, or which the Contracting Officer has full responsibility for administering all contractual actions arising from any task order issued by the ordering activity.

The Contracting Officer, or his/her representative, whose signature appears on this contract, has the sole responsibility and authority to make any changes to the provisions of this contract.

B. Content of Order:

Each task order place under this contract shall include the following information:

1. The contract number, task order number, and date of order.

2. Applicable accounting and appropriation data, and special invoicing instructions where applicable.

Additional information can include:

1. Item number and description, quantity and unit price.

2. Cost and hours (as negotiated), extended amounts, fee (if applicable), total estimated.

3. Delivery or performance date.

4. Place of delivery or performance (including consignee).

5. Packaging, packing, and shipping instructions, if any.

6. Such other terms and conditions as may be pertinent and peculiar to the particular tasks thereby ordered.

7. Individual orders will reflect the requirement of particular circumstances as applicable. Urgent orders will cite peculiar terms and requirements.

C. Processing of Orders by the Contractor: The Task Order Proposal and all supporting information shall be delivered to the Government not later than ten (10) calendar days after the Government issues the initial Task Order Request.

B.4 Minimum and Maximum Ordering Amounts

The contract minimum amount will be satisfied with award of the base contract and the contract maximum amount will be $120,000,000.00 over five (5) years.

B.5 Prices/Costs

The Contractor shall propose fully loaded fixed hourly rates for services expected to be required to meet all current and future requirements under this contract. These rates shall apply to all task orders awarded under this contract. Labor categories and skill levels shall reflect a broad range of technical and business disciplines and experience levels that may be needed to support both small and large developmental efforts. The labor category rates specified shall be fixed hourly rates which include, as a minimum, the following: wages, indirect costs (including overhead, local taxes, fringe benefits and general and administrative expenses), and profit.

B.6 Travel Policy The Government will reimburse the Contractor for the allowable travel costs incurred by the Contractor in performance of the contract and determined to be in accordance with FAR Part 15, subject to the following provisions:

GENERAL. Travel required for tasks assigned under this contract shall be governed in accordance with rules set forth for temporary duty travel in the Federal Travel Regulations and the Standardized Regulations (Government Civilians, Foreign Areas). The Federal Travel Regulations are available on a subscription basis from the Superintendent of Documents, U.S. Government Pricing Office, Washington, DC. 20402, Stock No. 022-001-81003-7. The Standardized Regulations (Government Civilians, Foreign Areas), Section 925 is available on a subscription basis from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC. 20403, Stock No. 744-008-00000-0. All Contractor travel shall be submitted in writing for review to the COTR and approved in advance by the Contracting Officer.

TRAVEL. Travel, subsistence, and associated labor charges for travel time are authorized for travel beyond a 50-mile radius of the Local Office or official duty station, whenever a task assignment requires work to be accomplished at a temporary alternate location. The Government will not reimburse the Contractor for any travel within a 50-mile radius of the Contractor's Local Office or official duty station.

PER DIEM. Per diem for travel on tasks assigned under this contract will be reimbursed at a rate not to exceed the amount authorized in the Federal Travel Regulations and the Standardized Regulations (Government Civilians, Foreign Areas).

LODGING. Lodging will be reimbursed up to the limits established in the Government travel regulations for Federal Government personnel.

MEALS AND INCIDENTALS. Meals and Incidentals (M&IE) shall be reimbursed at the applicable rate allowable established by the Government regulations and published in the Per Diem Supplement 925 to the Standardized Regulations.

AUTOMOBILES. For travel where use of personal automobile has been specifically authorized, mileage reimbursement shall be computed on the basis of miles traveled from starting point to destination per the current Rand McNally Mileage Guide. Other actual related miscellaneous expenses, such as toll and parking fees, accrued in conducting business associated with tasks assigned under this contract, will be reimbursed. Car rentals require advance COTR approval in writing except under unusual circumstances and will be authorized only when consistent with good business practice and generally at a cost not to exceed actual cost of renting compact automobile (one for maximum of five (5) Contractor personnel), unless extenuating circumstances (e.g., excess baggage) requires other arrangements.

TRAVEL ARRANGEMENTS. The Contractor is responsible for making all travel arrangements during the conduct of tasks assigned under this contract. All air travel shall be on Commercial Airlines Coach Class. The Contractor shall not charge for direct labor hours during travel.

The pricing schedule is follows:

Loaded Hourly Rates

Year

Rates

Rates

Specialist5

4 Class I- Senior management personnel, holding an advanced clinical, technical or professional degree, at the M.D., Ph.D., or Masters level, with a minimum of 10 years experience in analyzing biomedical, social sciences, behavioral, medical effectiveness, epidemiological or outcomes data, or similar scientific literature, research findings and data, preferably with significant experience related to development of clinical practice guidelines, medical review criteria, quality measures or indicators, or patient safety and other performance measures; biomedical or social sciences literature reviews and syntheses; meta-analysis; cost-effectiveness analysis; and/or experience in working with professional societies and healthcare delivery systems, such as hospitals and health plans. Class I personnel shall also have management experience that reflects an ability to command organizational resources and direct staff within the broader organization.

5 Class II- Associate management or clinical/professional/technical personnel, holding as advanced degree, at the M.D., Ph.D., or Master level, with a minimum of 5 years experience in analyzing biomedical, social sciences, medical effectiveness, epidemiological data, or similar scientific literature, research findings and data.

6 Class III- Intermediate clinical/technical personnel, holding a BS or BA degree and at least 3 years experience in technical activities of which 2 years experience are directly related to analysis of biomedical, social sciences, and related scientific literature and other data. The individual is capable of carrying out independent assignments with minimum supervision or acting as leader of small projects. Class III personnel includes specialists in science writing and editing, as well as computer programming.

7 Class IV- Data support, literature search and retrieval, report drafting, etc. at a research assistant level.

8 The database manager would work along with the data holder's epidemiologists and statistician to enable the queries to be run on the data holder's data.

SECTION C-STATEMENT OF WORK/SPECIFICATIONS

C.1 Scope of Work

a. The Contractor shall furnish the required personnel, materials, services, facilities, and otherwise do all things, required for or incident to the performance of the work as described below. The Contractor shall be prepared to develop a response to individual tasks as they are assigned.

b. With the award of the base contract, the Contractor shall establish and maintain a single Coordinating Center that enables medical product surveillance using a distributed data model. The responsibilities of the Coordinating Center are to establish and maintain:

1. A consortium of at least three automated healthcare data environments with varied data attributes (described below in C.1.b.1.b) to conduct analyses and other tasks ordered under task orders.

a. The Contractor shall provide technical expertise in pharmacoepidemiology and biostatistics for identifying, developing, validating, enhancing, and implementing advanced analytical and statistical methods (related to signal detection, signal strengthening, and signal validation) to address the specific issues, challenges, and objectives outlined for each task.

i. This would require demonstrated expertise in implementing standardized data elements in disparate automated healthcare data systems.

ii. Individual task orders may include testing data model options and/or characteristics to evaluate the effects on signal detection, signal strengthening, and signal validation.

b. Individual task orders will require the Contractor to access and utilize data from disparate automated healthcare data systems, including, but not limited to electronic health record systems, administrative claims databases, and patient registries, primarily for active medical product surveillance. It is preferred, but not required, that the Contractor be a holder of such an automated healthcare data system. The Contractor will need to demonstrate experience with methods for detecting, evaluating, and validating signals in these data. Additionally, they will have established working agreements with other holders of automated healthcare data, and with the researchers that are intimately familiar with those data, whether or not they have been used for active medical product surveillance before.

1. The Contractor shall have continuous access to various regularly updated automated healthcare data sources containing patient-level health encounter data from the United States in a platform that protects the integrity of patient records. The data sources shall each be a computerized system able to link each patient to all relevant medical care data including enrollment status, medical product exposure data, and coded medical procedures and outcomes. The data sources shall include, to the extent possible, a broad range of patient populations with regard to demographics and socioeconomic status. Linkage of this data source to additional information, including vital records, chronic disease and/or cancer registries, birth defect registries, and medical device registries, if available is also desirable.

2. The Contractor will only have direct access to any data owned by that organization. The Contractor will not create a repository for data from other data holders. Other data holders' data will remain behind their firewalls. Only summary results would be transmitted from the data holders to the Coordinating Center established under this contract.

3. The data sources shall have patient-level data describing health encounters and medical product use by individuals over time. The data sources shall have longitudinal data that shall be capable of following uniquely identifiable individuals over time.

4. Demographic information (e.g. age and gender), health history, diagnoses and procedures, and hospitalizations shall be available. Information on race/ethnicity shall be included where available, accompanied by documentation of the origin of this information.

5. For each patient these data shall contain prescription drug and biologic utilization information, typically including but not limited to the generic and brand name of the product, manufacturer, strength, dosage form, days supply, all dates dispensed, initial/continuing therapy indicator, quantity dispensed, instructions for use, indication for use and prescriber specialty. The data sources shall employ the use of a generally accepted, granular coding system for drugs and medical products, as well as for diagnoses and procedures. Furthermore, the Contractor shall have the ability to determine that the product was dispensed to the patient, rather than just prescribed to the patient.

6. Information on blood and tissue product use, including whole blood, plasma, red blood cells, platelets, and other transfused blood components, shall also be available. Plasma-derived products include polyclonal antibodies, immune globulin, antihemophilic clotting factors, albumin, other components extracted from human or animal plasma, and recombinant plasma-derived products. Examples of related biological products include, but are not limited to the following: hemin, thrombin, fibrin sealants, alpha-1 protease inhibitors, antivenins, Antithrombin III, digoxin immune FAB, and Protein C.

7. Optimally, medical device utilization by patients will also be captured, either at the device type level (e.g., by using diagnostic or procedural coding) or manufacturer level (e.g., by using registry data or bar code data).

8. Although accessible databases will often not have this information, it optimally will be useful to also capture specific product identification data in addition to brand and generic name, including: lot number (and model designation for devices); product integrity (e.g. visible damage to product or container closure); expiration date; whether a sterile product; and, whether a new molecular entity. To evaluate potential interactions, data shall be additionally captured when available on over the counter medications, dietary supplements and special diets.

9. All patient medical diagnostic information shall be represented in the data sources, including diagnoses and procedures associated with all ambulatory, emergency, chronic or acute care setting visits and their dates, diagnoses and procedures associated with related hospitalizations and their dates, and laboratory tests and results (if available) and their dates. Other health measures (such as family health history, height, weight, body mass index, smoking status, alcohol use, vital sign measurements, etc.), are of interest if available, as are results of imaging studies.

10. The Contractor shall have the capability of accessing medical records for validating coded diagnostic data used in analyses conducted under task order award. Patient identifiers will stay behind the firewalls of each data holder, and only aggregate information will be shared with the Coordinating Center and the Agency.

11. The Contractor shall be responsible for ensuring that the uses of the data are compliant with HIPAA and any applicable state and local laws. The Agency will require no patient-, provider-, or health plan-specific identifiers, and any aggregated results provided to the Agency will be provided in a standard format. All activities performed by the Contractor shall and must comply with standards for privacy of individually identifiable health information and protect the rights of human subjects. All analysis of data shall be performed by the data holders in their secure environment without transfer of patient level data. If FDA deems it necessary to review certain data to protect the public, data holders shall make those data available in compliance with HIPAA for FDA review.

12. All data accessed will be available as close to real-time as possible, so as to be conducive to surveillance.

13. All data accessed will be from privately held, non-federal data sources from US patients. (FDA has access to Federal data sources through other means, so establishing relationships with Federal data holders is out of the scope of work of this effort).

2. A Planning Board, including representatives from the participating data environments (described above in C.1.b.1) and the FDA, to develop documents that specify the governance structure of the consortium that will enable the conduct of the proposed medical product safety evaluations.

3. Under the Planning Board, a Safety Science committee charged with the day-to-day execution of analysis and evaluation for medical product safety.

4. A means to allow for secure communication among the consortium of participating data environments to enable coordination of specific active medical product surveillance queries.

5. Collaborations with FDA to identify, prioritize, and evaluate potential medical product-event pairs for medical product safety.

a. This would require the Contractor to have and maintain the ability to do the following, as outlined in the task orders, throughout the duration of the contract:

1. Identify queries that will be appropriate to answer important questions related to a given topic;

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

3. Derive measures of therapeutic use, prescription drug consumption, exposure, and utilization using automated healthcare data systems and epidemiologic techniques;

4. Access and use drug information resources and compendia;

5. Develop algorithms for identifying possible adverse drug events using standard coding systems including but not limited to the International Classification of Diseases (ICD-9-CM) and clinical procedure coding (e.g., CPT codes).

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

b. This would involve developing surveillance plans and study designs and developing and applying pharmacoepidemiological and biostatistical principles and methods.

c. Individual task orders may include developing, applying and/or evaluating advanced statistical approaches to safety signal detection, signal strengthening, and signal validation in automated healthcare data sources for regulated medical products during the postmarketing period.

d. Individual task orders may include training, as appropriate, on methods and tools employed in carrying out identified tasks. The type of training will be determined by the tools or methods developed, but could include development of training manuals, conduct of training sessions, or other methods deemed appropriate.

6. Processes that allow for use of the data that are compliant with HIPAA and any applicable state and local laws.

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 Technical 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 Reports/Deliverables

These requirements will vary by task and are to be determined upon issuance of individual task orders.

These may include:

· Weekly status/progress report via email to include work completed, work planned, issues to be addressed, project risks, level of effort/hour utilization and project decisions. Additionally, briefing materials (presentations) for FDA personnel in the form of PowerPoint slides or Microsoft Word white papers to articulate further detail about deliverables

· Teleconference to step through the weekly status/progress report with COTR and key stakeholders

All deliverables as defined by this Statement of Work shall be provided to the COTR in draft electronic form for comment before a final version is prepared in response to FDA comments. The COTR shall have 5 business days to review and comment on each final deliverable (excludes weekly status/progress report). The Contractor shall implement necessary changes within 5 business days of the change notification, unless otherwise by the COTR in writing The Contractor shall be familiar with Section 508 requirements as described at http://www.section508.gov/ in order to ensure that software and documents generated as part of the tasks are fully Section 508-accessible. Applicable sections include:

Computer Applications

Technical Standards (Subpart B)

· Software Applications and Operating Systems (1194.21)

· Web-based Intranet and Internet Information and Applications (1194.22)

· Video or Multimedia Products (1194.25)

· Presentations and training materials

Reports, Presentations and Training materials

Information, Documentation, and Support (Subpart D)

F.2 Delivery Instructions for Reports

Department of Health and Human Services

Food and Drug Administration 5600 Fishers Lane, Room 14B-45 Rockville, MD 20857

F.3 Period of Performance

The period of performance shall be from:

Base Year September 8, 2009 through September 7, 2010 Option Year One (1) September 8, 2010 through September 7, 2011

Option Year Two (2) September 8, 2011 through September 7, 2012

Option Year Three (3) September 8, 2012 through September 7, 2013

Option Year Four (4) September 8, 2013 through September 7, 2014

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

52.249-14 Excusable Delays.

APR 1984 tc “52.249-14 Excusable Delays. APR 1984 “ \l 2

SECTION G- CONTRACT ADMINSTRATION DATA

G.1 Contracting Officer Technical Representative tc \l3 "ARTICLE G.1. PROJECT OFFICER The following COTR will represent the Government for the purpose of this contract: (To be determined at the time of contract award) The COTR 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 COTR designation.

G.2 Contracting Officer

(a) The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds. No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions, or other stipulations of this contract and the individual task orders.

(b) No information, other than that which may be contained in an authorized modification to this contract, duly issued by the Contracting Officer, which may be received from any person employed by the United States Government, or otherwise, shall be considered grounds for deviation from any stipulation.

G.2.1 Contracting Officer Information

Department of Health and Human Services

Food & Drug Administration, OAGS

Attention: Doreen Williams, Room 2099

5630 Fishers Lane

Rockville, MD 20857

Phone: (301) 827-3366

Email: Doreen.Williams@fda.hhs.gov

G.2.2 Administrating Contract Specialist Information Department of Health and Human Services

Food & Drug Administration, OAGS

Attention: Tara Hobson, Room 2142

Phone: (301) 827-9691

Email: Tara.Hobson@fda.hhs.gov G.3 Key Personnel

The Contractor shall provide the names and qualifications of the key personnel assigned to this contract. The individuals cited below are key personnel.

Name

Title Program Manager

Principal Investigator

Principal Epidemiologist Senior Epidemiologist Senior Statistician

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

G.4 Invoice Submission

Pursuant to the provisions of the following FAR Clauses: 52.232-25, Prompt Payment (OCT 2008); 52.232-33, Payment by Electronic Funds Transfer-Central Contractor Registration (OCT 2003); and 52.232-34, Payment by Electronic Funds Transfer-Other Than Central Contractor Registration (MAY 1999) in Part II, Section I, the Contractor shall submit vouchers or invoices, using a Standard Form 1034 and Standard Form 1035 or facsimile, for costs incurred and claimed for reimbursement in accordance with the following instructions.

A. In accordance with clause 52.232-33 or clause 52.232-34, all payments made under this contract shall be made using electronic funds transfer through the Automated Clearing House (ACH). The Contractor shall provide the following information to the Food and Drug Administration, Office of Financial Services, HFA-720, 12345 Parklawn Drive, Rockville, MD 20857:

1. Routing transit number of the financial institution receiving payment.

2. Number of account to which funds are to be deposited.

3. Type of depositor account ("C" for checking, "S" for savings).

B. An original and two (2) copies shall be submitted to the attention of the Administrating Contract Specialist at the following address:

Department of Health and Human Services

Food & Drug Administration, OAGS

Attention: Tara Hobson, Room 2142

Phone: (301) 827-9691

Email: Tara.Hobson@fda.hhs.gov

SECTION H-SPECIAL CONTRACT REQUIREMENTS

H.1 Access to Non-Public Information tc " H-[ FDA 1350 Access to Non-Public Information " \l 2All Contractor and subcontractor employees are required to sign the Contractor's Commitment to Protect Non-Public Information Agreement form provided as an attachment to this contract (Attachment 1). If a person who has signed this agreement resigns, is dismissed, or is otherwise no longer working on this contract, the Contractor shall notify the FDA Contracting Officer’s Technical Representative (COTR) and Contracting Officer. Any new Contractor and subcontractor employees assigned to this contract shall sign the form, and the Contractor shall hand-deliver it (ten (10) days prior to commencement of work) to the Contracting Officer.

The prime Contractor, subcontractors, and consultants shall not be provided nor possess non-public information in any form unless written approval and a facility clearance have been granted.

Briefings

A FDA representative (typically, the COTR) will conduct an orientation briefing for the Contractor/Contractor employees. The briefing will stress: (1) the importance of protecting non-public information; (2) specified computer/ADP requirements as outlined in the DHHS Automated Information Systems Security Program Handbook; and (3) the consequences of unauthorized disclosure of non-public information. Briefing updates will be conducted annually.

The Contractor shall brief all Contractor employees, subcontractors and consultants regarding the sensitivity of the information to be handled under the contract and of the responsibility to protect it. The briefing shall stress that the information is non-public and shall not be disclosed to any unauthorized source. The Contractor shall conduct an updated briefing annually and shall submit a report to the FDA COTR within ten (10) days after the briefing which includes: an outline of the briefing, a copy of any briefing materials, date briefing was conducted and the names of the attendees.

If this is an automated data processing/telecommunications (ADP/TC) contract, in addition to the above briefings, the FDA COTR and the FDA Center/Office Information Systems Security Officer (ISSO) will brief Contractor and subcontractor personnel and consultants on security measures required pertinent to any hardware/software being utilized. Furthermore, appropriate Contractor and subcontractor personnel and consultants shall attend training courses as directed by the FDA to fulfill requirements of the Computer Security Act of 1987. These courses are generally one (1) day in length; and attendance at one (1) course is sufficient. This training will be provided at no cost to the Contractor.

Provide briefings to the Agency on deliverables and findings, e.g., following proposed approaches to analysis, the findings of conducted analyses, and other tasks, to obtain agency input.

All task orders issued by the Agency under this contract shall require the following:

1. Confidential or otherwise privileged information disclosed by the Agency with Contractor shall not be used by the Contractor to solicit or in any other way encourage industry funding/financial sponsorship of projects to be performed by the Contractor. In the event that an outside party such as a drug sponsor independently requests that the Contractor conduct surveillance on a safety issue that the Agency has previously discussed with the Contractor but the Agency has not requested the Contractor to perform the surveillance on that issue, the Contractor may conduct such surveillance only if both of the following conditions are satisfied: (1) the Contractor shall not divulge confidential and privileged information previously disclosed by the

Agency; and (2) the Contractor shall recuse itself from all subsequent conversations with the Agency about the safety of the involved drug product(s).

2. Each Contractor/subcontractor employee who may have access to non-public Department information under this task order shall complete the Commitment to Protect Non-Public Information - Contractor Agreement (http://nitaac.nih.gov/downloads/ciosp2/Contractor_Employee_Non-Disclosure.doc). A copy of each signed and witnessed Non-Disclosure agreement shall be submitted to the COTR prior to performing any work under the contract.

3. The Contractor shall keep confidential all communications with FDA, or with data holders, concerning queries and responses to queries, including the responses to the queries, unless authorized by the Agency in writing to make such information public. The Contractor shall guarantee strict confidentiality of the information/data that it is provided by the Government during the performance of the task order. The Government has determined that the information/data that the Contractor will be provided during the performance of the task order is of a sensitive nature. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer.

4. This contract shall not constrain the Agency from releasing deliverables from these tasks prior to formal publication or presentation in a scientific forum. Under these circumstances, the Agency will work with the site collaborators to avoid jeopardizing publication of results.

5. The Contractor shall meet the obligations applicable to a "qualified entity" described in section 505(k)(4)(G) of the Federal Food, Drug, and Cosmetic Act, specifically:

· ENSURING PRIVACY.—The Contractor shall ensure that it will not use data under the contract in a manner that—

a. violates the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996;

b. violates sections 552 or 552a of title 5, United States Code, with regard to the privacy of individually-identifiable beneficiary health information; or

c. discloses individually identifiable health information when presenting drug safety signals and trends or when responding to inquiries regarding drug safety signals and trends.

· COMPONENT OF ANOTHER ORGANIZATION.—If the Contractor is a component of another organization—

a. the Contractor shall establish appropriate security measures to maintain the confidentiality and privacy of such data; and

b. the Contractor shall not make an unauthorized disclosure of such data to the other components of the organization in breach of such confidentiality and privacy requirement.

FEDERAL HEALTH ARCHITECTURE (FHA) HEALTH INFORMATION TECHNOLOGY REQUIREMENTS

INTEROPERABILITY

Executive Order 13410:

Promoting Quality and Efficient Health Care in Federal Government Administered or Sponsored Health Care Programs promotes efficient delivery of quality health care through the use of health information technology, transparency regarding health care quality and price, and incentives to promote the widespread adoption of health information technology and quality of care. To support this mission, the awardee shall, at a minimum, implement the following clauses(s)/condition(s) and, in doing so, the actions and steps taken to implement the clause(s)/condition(s) shall not impose additional costs onto the Federal Government.

In Response to Executive Order 13410, the following clauses shall apply:

· Use recognized health information interoperability standards at the time of the system update, acquisition, or implementation, in all relevant information technology systems supported, in whole or in part, through this agreement/contract.

Where Offerors/awardees support or participate in health information [or data] exchange with disparate entities, offerors/awardees must be compatible with the following, where applicable architectures and data-exchange standards already exist:

· HHS Nationwide Health Information Network (NHIN) (www.hhs.gov/healthit/healthnetwork/background).

· FDA Data Standards Council: Data Exchange Standards (http://www.fda.gov/oc/datacouncil/)

· HHS Data & Technical Standards: Health Information Technology Standards Panel (HITSP) (http://www.hhs.gov/healthit/standards/activities/)

H.2 Reporting Matters Involving Fraud, Waste and Abuse

Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in FDA funded programs is encouraged to report such matters to the HHS Inspector General’s Office in writing or on the Inspector General’s Hotline. The toll free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be handled confidentially. The e-mail address is Htips@os.dhhs.gov and the mailing address is:

Office of Inspector General

Department of Health and Human Services

TIPS HOTLINE

P.O. Box 23489

Washington, D.C. 20026

H.3 Anti-Lobbyingtc \l3 "ARTICLE H. . ANTI -LOBBYING a.

Contract funds shall only be used for normal and recognized executive-legislative relationships. Contract funds shall not be used, for publicity or propaganda purposes; or for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State legislature, except in presentation to the Congress or any State legislature itself.

b.

Contract funds shall not be used to pay salary or expenses of the Contractor or any agent acting for the Contractor, related to any activity designed to influence legislation or appropriations pending before the Congress or any State legislature.

H.4 Organizational Conflicts of Interest As a regulatory agency charged with protection of the public health, the Food and Drug Administration (FDA) must maintain public confidence in the integrity of its decisions. The FDA has various policies and procedures that safeguard against both actual and apparent conflict of interest (COI) on the part of its employees. It is additionally critical that the FDA be assured that there is no actual or apparent COI on the part of either the Contractor's organization or its individual employees in performance of this contract action.

Offerors submitting proposals to perform work under this contract must assure the protection of the information and data they receive in performance or under this contract from unauthorized use or disclosure, and must avoid actions that will cause a reasonable person to question the impartiality of the Contractor, its employees, or the Government in the performance of this immediate contract and potential participation in future actions. Contractor will be held to the restrictions of the Organizational Conflict of Interest clause, unless an acceptable mitigation of risk plan is proposed, found acceptable by the Government and enforced.

POTENTIAL CONFLICTS OF INTEREST SPECIFIC TO THIS CONTRACT -

Offerors shall review the Statement of work included in each RTOP in detail to identify any particular aspects that may present organizational or individual COI, either actual or apparent.

DEFINITION OF CONFLICT OF INTEREST - Conflict of interest means that because of other activities or relationships with other persons or organizations, a person or organization is unable or potentially unable to render impartial assistance or advice to the Government, that the person's or organization's objectivity in performing the contract is or might be otherwise impaired, or that the person or organization has or might acquire an unfair competitive advantage (See FAR 9.501).

SUBMITTAL OF CONFLICT OF INTEREST PLAN - If it is determined that a COI exists, Offerors shall submit a COI Plan which outlines procedures to avoid, neutralize or mitigate COIs, whether actual or apparent, throughout the period of performance of the contract and the restriction period. The plan shall address step-by-step the checks and balances in place to detect potential or actual COI, organizationally and in connection with individual personnel, and shall describe the process of reporting COI to the FDA. It shall contain a statement of consent for FDA to inspect all records, correspondence and other documentation related to COI. If the COI Plan is deemed unacceptable by the FDA, further evaluation of the Offeror's proposal may not occur. Upon execution of the contract, the COI Plan shall be incorporated by reference into the contract.

The plan shall include elements of the following:

A. CORPORATE STRUCTURE - The plan shall describe any parent company relationship, and list all affiliates and subsidiaries whose work may present a COI. In addition, the plan shall be updated as soon as there are any changes that may affect work performed under this contract.

Offerors must describe all relevant information concerning any past, present or planned interests that may have a bearing on whether they (including their chief executives and directors, or any proposed consultant or subcontractor) have an organizational conflict of interest in regard to the responsibilities described in the Statement of Work.

B. INDIVIDUAL EMPLOYEE COI/NONDISCLOSURE AGREEMENTS - The COI Plan shall require that ALL employees (any Offeror or employee of an Offeror, including a Contractor, subcontractors, consultants) performing work under this contract, and/or any work related to this contract, execute a COI/Nondisclosure Agreement. In signing this agreement, the individual agrees to report to the proper authority within the Company, as identified by the Company, information that may affect a determination of individual COI, whether actual, apparent, or potential. This means that employees must disclose/identify all specific financial interests (e.g., stocks, stock options, bonds) and activities (e.g., other employment and consulting).

The COI/Nondisclosure Agreement must also contain a statement assuring FDA that the individuals who will be performing work under this contract have read and understand the company's COI plan and procedures. A list of those employees who have done so shall be retained by the company.

The COI/Nondisclosure Agreement shall include, but need not be limited to, the following:

1) An assurance that the employee has agreed to act impartially and not give preferential treatment to any individual or organization who has submitted applications, information and/or data to FDA.

2) An assurance that the employee has agreed not to solicit any gift or other item, nor accept any gift or other item, of monetary value exceeding $20 from any person or entity seeking official action from, doing business with, or conducting activities related to the evaluations and work performed under this contract. Aggregate market value of individual gifts shall not exceed $50.00 in a calendar year.

3) An assurance that the employee has agreed not to disclose to any unauthorized person any information and/or data within his or her purview, or to which he/she has access as a result of performing work under this contract.

4) An assurance that the employee has agreed not to engage in financial transactions using nonpublic information or allow the improper use of such information to further any private interest.

5) An assurance that the employee has agreed not to participate in any matter involving specific parties who are likely to or can directly affect the employee’s own financial interest or the financial interests of a member of his household or a relative with whom they have a close personal relationship.

6) Employees shall disqualify themselves from participating in particular matters involving former employers, or their representatives, and from whom they have worked within the past one (1) year.

FDA will, upon request, provide information to Offerors on the COI standards it applies to its personnel. These standards may be adopted in the COI Plan as one means of safeguarding against individual COI.

C. ANNUAL SUBMISSION OF COI/NONDISCLOSURE AGREEMENTS - The COI Plan shall describe the company process for…