EMR Data RFP.DOC

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 Description of Services The Food and Drug Administration has a requirement to acquire direct access to nonfederal electronic medical record (EMR) data. Independently and not as an agent of the U.S. Federal Government, the Contractor shall furnish the necessary personnel, materials, services, facilities, and otherwise do all things necessary for or incident to provide direct, immediate Internet or network-based access to a longitudinal, population-based electronic medical record (EMR) data resource. See Section C, “Description/Specification/Work Statement” for a complete description of the services to be performed.

The requirements of this contract are broken down into a Fixed Price portion and an Indefinite Delivery Indefinite Quantity (IDIQ) portion, as follows:

1) Fixed Price Portion: Unlimited access to EMR Data, validation studies and linkages to other information, FDA documented disclosure policy, documented process for sharing data in collaborative research projects, projection or other appropriate methodology, current and complete data dictionary, on-site training programs and training materials, technical support including notification of and access to upgrades and/or new releases of the data and software, and disclosure clearance services. Within these parameters, the Contractor shall provide all work required under Section C of this contract.

2) Indefinite Delivery Indefinite Quantity Portion: Customized analysis services priced by fixed hourly rates. Task Orders would be awarded on an as needed basis and can be either fixed price or labor hour type.

B.2 Compensation/Payment A. FIXED PRICE PORTION: As consideration for the Fixed Price Portion of this contract, as described in Section C, “Description/Specification/Work”, the government shall pay the contractor according to the pricing schedule below.

B. INDEFINITE DELIVER INDEFINITE QUANTITY PORTION: The Contractor will be paid in accordance with the IDIQ schedule specified, for each negotiated Task Order issued under this contract. It is estimated that the total amount of the Task Orders for the base year and four one year options shall not exceed $1,500,000 with a minimum amount of $100,000.

B.3 Contract Period - Base Year

September 27, 2009 – September 26, 2010 (12 months)

BASE YEAR

Total Price for Items 0001 through 0009:

1. Fixed Price Portion - Base Year, as consideration for the Fixed Price Portion of this contract, as described in Section C, “Description/Specification/Work”, the government shall pay to the contractor a fixed quarterly amount of $__________.

2. Indefinite Delivery Indefinite Quantity Portion: Task Orders that are separately negotiated with the contractor shall be at the rates identified below. Upon completion and acceptance of the work, the contractor shall be paid the agreed upon amount. The following are the labor category costs to be used for pricing Task Orders.

Project Manager

Senior Computer Systems Analyst

Application Programmer

Statistician

Pharmacist

Senior Training Specialist

Other Direct Costs

Medical Record Abstraction (cost per record)

Hospital IRB Fee

Travel associated with any task order will be negotiated at time of award according to Government per diem rates.

B.4 Contract Period - Option Year 1

September 27, 2010 – September 26, 2011 (12 months)

OPTION YEAR 1

Total Price for Items 1001 through 1009:

1. Fixed Price Portion – Option Year 1, as consideration for the Fixed Price Portion of this contract, as described in Section C, “Description/Specification/Work”, the government shall pay to the contractor a fixed quarterly amount of $__________.

2. Indefinite Delivery Indefinite Quantity Portion: Task Orders that are separately negotiated with the contractor shall be at the rates identified below. Upon completion and acceptance of the work, the contractor shall be paid the agreed upon amount. The following are the labor category costs to be used for pricing Task Orders.

Project Manager

Senior Computer Systems Analyst

Application Programmer

Statistician

Pharmacist

Senior Training Specialist

Other Direct Costs

Medical Record Abstraction (cost per record)

Hospital IRB Fee

Travel associated with any task order will be negotiated at time of award according to Government per diem rates.

B.5 Contract Period - Option Year 2

September 27, 2011 – September 26, 2012 (12 months)

OPTION YEAR 2

Total Price for Items 2001 through 2009:

1. Fixed Price Portion – Option Year 2, as consideration for the Fixed Price Portion of this contract, as described in Section C, “Description/Specification/Work”, the government shall pay to the contractor a fixed quarterly amount of $__________.

2. Indefinite Delivery Indefinite Quantity Portion: Task Orders that are separately negotiated with the contractor shall be at the rates identified below. Upon completion and acceptance of the work, the contractor shall be paid the agreed upon amount. The following are the labor category costs to be used for pricing Task Orders.

Project Manager

Senior Computer Systems Analyst

Application Programmer

Statistician

Pharmacist

Senior Training Specialist

Other Direct Costs

Medical Record Abstraction (cost per record)

Hospital IRB Fee

Travel associated with any task order will be negotiated at time of award according to Government per diem rates.

B.6 Contract Period - Option Year 3

September 27, 2012 – September 26, 2013 (12 months)

OPTION YEAR 3

Total Price for Items 3001 through 3009:

1. Fixed Price Portion – Option Year 3, as consideration for the Fixed Price Portion of this contract, as described in Section C, “Description/Specification/Work”, the government shall pay to the contractor a fixed quarterly amount of $__________.

2. Indefinite Delivery Indefinite Quantity Portion: Task Orders that are separately negotiated with the contractor shall be at the rates identified below. Upon completion and acceptance of the work, the contractor shall be paid the agreed upon amount. The following are the labor category costs to be used for pricing Task Orders.

Project Manager

Senior Computer Systems Analyst

Application Programmer

Statistician

Pharmacist

Senior Training Specialist

Other Direct Costs

Medical Record Abstraction (cost per record)

Hospital IRB Fee

Travel associated with any task order will be negotiated at time of award according to Government per diem rates.

B.7 Contract Period - Option Year 4

September 27, 2013 – September 26, 2014 (12 months)

OPTION YEAR 4

Total Price for Items 4001 through 4009:

1. Fixed Price Portion – Option Year 4, as consideration for the Fixed Price Portion of this contract, as described in Section C, “Description/Specification/Work”, the government shall pay to the contractor a fixed quarterly amount of $__________.

2. Indefinite Delivery Indefinite Quantity Portion: Task Orders that are separately negotiated with the contractor shall be at the rates identified below. Upon completion and acceptance of the work, the contractor shall be paid the agreed upon amount. The following are the labor category costs to be used for pricing Task Orders.

Project Manager

Senior Computer Systems Analyst

Application Programmer

Statistician

Pharmacist

Senior Training Specialist

Other Direct Costs

Medical Record Abstraction (cost per record)

Hospital IRB Fee

Travel associated with any task order will be negotiated at time of award according to Government per diem rates.

SECTION C - DESCRIPTION/SPECIFICATION/WORK STATEMENT

C.1 Scope of Work Independently and not as an agent of the U.S. Federal Government, the Contractor shall furnish the necessary personnel, materials, services, facilities, and otherwise do all things necessary for or incident to provide direct, immediate Internet or network-based access to a longitudinal, population-based electronic medical record (EMR) data resource:

SECTION 1

GENERAL

Note: Italicized words are defined in the glossary

C.1.1 Background:

A vital part of FDA’s mission is to protect the public health. The Office of Surveillance and Epidemiology (OSE) and the Office of Biostatistics and Epidemiology (OBE) contribute to this effort by evaluating drug and biologics risks and promoting their safe use by the American people. In early 2005, FDA commissioned the Institute of Medicine (IOM) to conduct a study to examine the US drug safety system. In September 2006, the Institute of Medicine Report entitled, “The Future of Drug Safety: Promoting and Protecting the Health of the Public” was released and outlined numerous activities designed to continue to strengthen the FDA’s drug safety program. In response to this report from the IOM, and under authorization by Title IX of the Food and Drug Administration Amendments Act of 2007 (FDAAA 2007), this effort is intended to develop the capability for advanced analyses of drug and biologics safety data in order to improve the quality of post-market risk/benefit evaluation and enhance the ability of FDA to make timely assessments of drug and biologics safety data. Consequently, FDA is devoting greater resources to the area of postmarketing safety and is expanding the roles and responsibilities of OSE within the Center for Drug Evaluation and Research (CDER) and OBE within CBER. In furtherance of this effort, FDA seeks continued access to nonfederal, longitudinal patient-level electronic medical record (EMR) data.

FDA currently has several tools available to address postmarketing safety issues. These include a spontaneous reporting system for adverse events related to drug and biologics therapy; several complementary product utilization databases; and a scientific program to support epidemiologic investigations that provides indirect access to US claims-based health encounter data for pharmacoepidemiology studies. To strengthen and complement these resources, FDA seeks to acquire direct access to nonfederal EMR data. This database shall contain searchable patient-level, prescription information along with health history, details of ambulatory care visits, information relating to the full hospitalization record, laboratory test results, and death certificate data, and an ability to link to disease registries, all integrated in the context of an EMR. The majority of these data should be coded in individual fields at the patient level. FDA recognizes that such a data resource may cover patient populations outside the US.

To address postmarketing issues confronting the agency, this database shall provide FDA scientists with the ability to perform hands-on, population-based epidemiologic studies pertaining to drug safety, using nonfederal, nonfederal, commercially available, directly accessible data from longitudinal EMRs that are, by their nature, more detailed than administrative claims data.

C.1.2 Objectives:

The Contractor shall:

a. Provide direct, unlimited access to nonfederal, longitudinal, population-based EMR data, including but not limited to the following types of information at a patient level: demographic, health history, diagnoses and procedures, laboratory test results, drug and biologic utilization and administration, and health encounters (e.g. hospitalizations, specialist visits, etc.);

b. Provide FDA personnel with unlimited access to these data in a multi-user environment and in real-time (access shall be provided via Internet or FDA network-based); and

c. Provide FDA personnel with the ability to download (or obtain by other means) large datasets as needed, for the purpose of conducting epidemiological drug and biologics safety studies.

d. Provide technical and clinical support in the area of drug safety research to assist in the utilization of the data resource for epidemiologic studies.

C.1.3 Longitudinal Patient-Level Electronic Medical Record Data Resource:

C.1.3.1 Overall Database Requirements:

The essential requirements shall include the following elements. The successful Contractor(s) shall have continuous direct access to a nonfederal, commercially available, population-based, EMR data resource with access to primary medical records covering a minimum of two million active patients as of June 1, 2008. These data shall be accessible in real-time via a secure Internet or network-based method permitting simultaneous, multi-user access through a user friendly data query tool. The data resource shall be in English and include English documentation, English-language-based training, and technical support. To validate clinical events, the Contractor shall have the ability to obtain additional clinical documentation for example hospital discharge records or physician notes. The data resource shall be coded using a generally accepted clinical and therapeutic coding systems (e.g. ICD, Read codes, NDC, ATC, etc.) including data dictionaries necessary to properly interpret the codes.

The EMR data resource shall contain updated information on a stable patient population, with low patient turnover, thereby permitting long-term longitudinal follow up of most patients for delayed adverse effects from drugs or other medical products.

The EMR data resource shall contain sufficient detail so that FDA has the ability to estimate the contribution of various risk factors (e.g. age, gender, dose, coexisting disease, concomitant medications, and disease severity (if available) associated with the occurrence of medical events of interest without Contractor intervention.

To validate clinical events, the EMR data resource shall have the capability to obtain de-identified, supplementary paper copies of medical record data (i.e., hospitalization and/or specialty physician referral letters) in a timely manner, when necessary. The EMR data resource shall provide the capability of linking the data to vital statistics and/or disease-specific (e.g., cancer) registries.

The EMR data resource shall allow the FDA researchers to select, count and follow individuals using a particular drug or biologic product or with a specific medical condition longitudinally.

The EMR data resource shall allow the FDA researchers to form groups of patients exposed to multiple drug or biologic products and to follow them for the occurrence of multiple outcomes.

The Contractor shall provide FDA internal use of the EMR data resource without prior restraint, e.g., institutional review board (IRB) approval. FDA acknowledges that any external release of results based on these data may be subject to mutually agreed-upon disclosure policies.

The Contractor shall provide full disclosure of any updates for data collection, coding, and configuration methods and changes to allow FDA to appropriately interpret findings. The Contractor shall provide an updated data variable dictionary annually.

The EMR data resource shall include a generally accepted and recognized coding system for both drugs and clinical events.

FDA will require no patient-, provider-, or health plan-specific identifiers. It shall be solely the Contractor’s responsibility to de-identify the data for FDA use to ensure HIPAA compliance.

C.1.3.2 Data and Population size characteristics:

The data resource shall continuously provide the overall number of individuals participating, the number of active individuals, and the number of individuals available for research; the demographic distribution and geographic diversity of participants, including representation of special populations of interest to the FDA, including children (1-17), women of childbearing age (15-45), and elderly (65+); demographic comparison of the database population to the larger geographic population (e.g., state, province, country) from which it is derived; a description of patients, services, or pharmaceutical products that may not be included in the database (e.g., homeless, transient/immigrant or other persons not included; elective procedures, psychiatric or prenatal care or services not included; acute or chronic conditions treated or services provided at anonymous or separate outpatient clinics; drug or biologic products whose administration, prescription, or purchase are not captured in the database); and an updated availability and description of enrollment data (including inactive or temporary patients) including yearly turnover rates.

C.1.3.3 Patient demographics requirements:

a. Age (specify method by which age obtained)

b. Gender

c. Race/ethnicity

d. Socioeconomic status indicator(s)

e. Unique encrypted ID number that is constant over time

C.1.3.4 Patient-specific drug or biologic therapy information shall include:

a. Generic name of drug/medical product

b. Established name of drug/medical product

c. Strength

d. Dosage form

e. Prescribed dose

f. Instructions for use

g. All dates prescribed or dispensed

h. Initial or continuing therapy indicator

i. Reason for drug/medical product discontinuation

j. Days supply

k. Prescriber specialty

l. Quantity dispensed

m. Indication for drug/medical product therapy

n. Evidence of validation of prescribed versus dispensed drug therapy data

C.1.3.5 Patient medical diagnostic information shall include:

a. Diagnoses and procedures associated with ambulatory visits

b. Diagnoses and procedures associated with hospitalizations

c. Referrals to specialists and associated diagnoses

d. Laboratory tests and results

e. Health measures (such as height, weight, BMI, smoking status, alcohol use, blood pressure measurements, pregnancy, immunizations, etc.)

f. Dates of ambulatory visits, hospitalizations, referrals, health measures, and laboratory tests

g. Past medical and family health history

h. Indicator or link to patient mortality information

i. Maternal/child linkage

j. Linkage to cancer or other chronic disease registries

k. Availability of de-identified comments or physician notes with text search capability

l. Capability of accessing supplementary paper medical records for validating coded data (e.g., hospital discharge summaries, specialty physician referral letters, etc.)

m. Complete data dictionary

n. Percentage of missing or incomplete information for basic data elements

C.1.4 Online Data Availability:

C.1.4.1 The Contractor shall provide on an annual basis documentation on any changes to the total number of usable number of years of data available, number of years of data available online on a standard basis, the overall mean, median, range and distribution of observation time for active patients in the data resource, and the lag time between the data of service and online availability.

C.1.5 Management Requirements:

C.1.5.1 This contract shall have a mutually agreed upon policy for sharing or publishing results outside of the FDA as well as for sharing or publishing results prior to publication.

C.1.5.2 As part of its regulatory activities, FDA shall, at times, require disclosure of scientific and technical articles, study results, presentations, public health advisories, and similar works involving aggregated data to entities outside the Agency including the general public. For activities that require disclosure of aggregated data a timely, mutually agreed upon disclosure policy shall be in place.

C.1.5.3 The FDA shall continue to require the ability to release aggregated data through a mutually agreed upon Data Disclosure Clearance process for data obtained during the contract period for a period of one year after Option Year 4. During the one-year period following the expiration of the contract, FDA shall not require data access service, but will require the services of processing clearance requests which will be acquired under a separate follow-on purchase order.

C.1.5.4 After the one-year period for clearance services, the FDA will notify the contractor of the aggregated data release and accept the Contractor’s requested revisions, but will not require formal approval for release.

C.1.5.5 As part of its regulatory activities, FDA shall, at times engage in collaborative research projects with third parties outside of FDA for specific research projects of public health importance that are initiated by and for the benefit of FDA. These collaborations shall require FDA to have the ability to share project specific aggregated or raw data with third parties for collaborative research projects. For these collaborations that require sharing of aggregated or raw data, a timely, mutually agreed upon clearance procedures shall be in place. These Procedures shall include terms and conditions for third party collaborations.

C.1.5.6 The Contractor shall provide e-mail notification of any data adjustments and corrections. The Contractor shall notify FDA about any circumstances resulting in loss of or lack of access to data from the database. Additionally, the Contractor shall notify FDA a minimum of 48 hours in advance of planned downtime of the database and notify FDA within 30 minutes from the onset of unplanned downtime within normal hours (Monday-Friday, 8:00 AM – 6:30 PM Eastern Time) with an estimate of time to restoration of access to the database.

C.1.5.7 The Contractor shall provide a support package consisting of technical, analytical, and clinical support throughout the length of the contract. The contractor shall provide specialized training for those in the FDA that will have direct access to the data resource.

C.1.5.8 In addition, the Contractor will be required to conduct an on-site annual meeting for the purposes of conducting a general training session and discussing product enhancements, contract performance, and FDA satisfaction with all deliverables.

C.1.5.9 The Contractor shall participate in the CDER secure electronic mail system (See Attachment 4 to protect any sensitive data which may be transmitted electronically between the Contractor and the FDA.

C1.5.10 The Contractor shall have full conformance or level of conformance with Section 508 standards. (See Attachments 2 & 3) C.1.6 The Contractors proposed staff shall be identified and responsible for the overall management of this contract, including coordination and cooperation with Federal Government staff and policy officials, direction and oversight of this contract, and assuring quality and timeliness of work performed.

C.2 FDA Technical Environment:

C.2.1 Internet Access - The FDA has direct, desktop access to the Internet. The standard browser package is Microsoft Internet Explorer version 6.x. Ideally, the data resource shall be accessible using this package without the need for the FDA to purchase or install additional software or hardware.

C.2.2 Data Downloading - The FDA uses standard statistical and data management software, such as SAS, Microsoft Access and Microsoft Excel, and shall require the ability to obtain datasets in formats that are compatible with these packages. The FDA shall also require the ability to obtain datasets in ASCII format.

C.2.3 Local Area Network Configuration - The FDA uses a central-server network model. The configuration is a wide area network with TCP/IP running on a 10/100 Mbs network. There is redundant T1 connectivity between organizational units. The FDA cannot provide a diagram of the network. FDA does not support dial-in or modem-based access.

C.2.4 Client Software Documentation – If access to the data resource requires installation of client software on FDA PCs, all instructions and support for the installation of that software shall be in English.

C.2.5 Security – Any client software installed on FDA computers for the purposes of accessing the data resource should not use key-logging and/or network capturing functionality to transmit any data from the FDA system except for login information specific to the data resource and data (e.g. SQL queries or similar methods) accessing the Offeror’s application data sets.

SECTION D - PACKAGING AND MARKING tc " D - PACKAGING AND MARKING " D.1 Marking Instructions for End Items tc "D.1 FDA 500 SECTION D - PACKAGING AND MARKING " \l 2 The Contractor shall mark all correspondence, reports, submittals, schedules, invoices, etc., concerning this contract with the contract number.

SECTION E - INSPECTION AND ACCEPTANCE tc " E - INSPECTION AND ACCEPTANCE " E.1 Inspection and Acceptance tc "E.1 FDA 700 SECTION E - INSPECTION AND ACCEPTANCE " \l 2 Pursuant to the appropriate inspection clause as provided below, final inspection and acceptance of all items called for by this contract shall be made by the FDA Contracting Officer Technical Representative (COTR) at the Food and Drug Administration, White Oak Campus, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993.

52.252-2 Clauses Incorporated by Reference. (FEB 1998) tc "E.2 52.252-2 Clauses Incorporated by Reference. (JUN 1988) " \l 2 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 this address (www.arnet.gov)

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 tc " F - DELIVERIES OR PERFORMANCE " F.1 Proposed Deductions for Not Meeting the Acceptable Quality Level In each of the Performance Requirements Summaries for this solicitation, each Contractor shall propose the amount of deduction that they consider to be reasonable for the unacceptable performance of required services. The Government will subjectively evaluate these proposed deductions by comparing them to the Contractor’s total contract price and as an indication of the Contractor’s confidence and ability in satisfactorily meeting the performance standards.

Note: Submit Performance Requirement with proposal. For each of the Required Services, the successful Contractor shall not be penalized in excess of $25,000 per year.

52.252-2 Clauses Incorporated by Reference. (FEB 1998) tc "F.7 52.252-2 Clauses Incorporated by Reference. (JUN 1988) " \l 2 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 this address (www.arnet.gov)

52.242-15 Stop-Work Order.

AUG 1989

52.242-17 Government Delay of Work

APR 1984

SECTION G - CONTRACT ADMINISTRATION DATA tc " G - CONTRACT ADMINISTRATION DATA " tc "G.1 FDA 1100 SECTION G - CONTRACT ADMINISTRATION DATA " \l 2G.1 Contracting Officer Technical Representative (COTR)tc "G.2 FDA 1104 Project Officer. " \l 2 The COTR responsible for the acceptance of work provided hereunder will be designated by separate correspondence.

G.2 Technical Direction

G.2.1 Performance of the work under this contract shall be subject to the technical direction of the COTR. The term “technical direction” is defined to include the following:

1.

Technical directions to the Contractor which shift work emphasis between work areas or tasks, requiring pursuit of certain lines of inquiry, filling in details or works that otherwise serves to accomplish the contractual scope of work;

2.

Providing information to the Contractor for assistance in the interpretation of specifications or technical portions of the work description; and

3.

Review and, where required by the contract, approval of technical reports, specifications, and technical information to be delivered by the Contractor to the Government under the contract.

G.2.2 Technical direction must be within the general scope of work stated in the contract. The COTR does not have the authority to, and may not, issue any technical direction which (1) constitutes an assignment of additional work outside the general scope of the contract; (2) constitutes a change as defined in the contract clause entitled “Changes,” (3) in any manner causes an increase or decrease in the total contract price; or (4) changes any of the expressed terms, conditions, or specifications of the contract.

G.2.3 All technical directions shall be issued in writing by the COTR or shall be confirmed by him/her in writing within (2) working days.

G.2.4 The Contractor shall proceed promptly with the performance of technical directions duly issued by the COTR in the manner proscribed by this clause and within his/her authority under the provisions of this clause.

G.2.5 If, in the opinion of the Contractor, any instruction or direction issued by the COTR is not within one of the categories as defined in G.2.1 through G.2.4 above, the Contractor shall not proceed but shall notify the Contracting Officer, in writing, within five(5) working days after the receipt of any such instruction or direction and shall request the Contracting Officer to modify the contract accordingly. Upon receiving such notification from the Contractor, the Contracting Officer shall issue an appropriate contract modification or advise the Contractor, in writing, that, in his/her opinion, the technical directions are within the scope of this contract and do not constitute a change under the “Changes” clause of the contract. The Contractor shall thereupon proceed immediately with the direction given. Any failure of the parties to agree upon the nature of the instruction or direction, or upon the contract action to be taken with respect thereto, shall be subject to the provisions of the contract clause entitled “Dispute.”

G.3 Invoice Submission

The Contractor shall submit vouchers or invoices in accordance with the following FAR Clauses: 52.232-25, Prompt Payment (OCT 2008); and 52.232-33, Payment by Electronic Funds Transfer – Central Contractor Registration (OCT 2003); in Part II, Section I, in accordance with the following instructions.

G.3.1 In accordance with 52.232-33, Payment by Electronic Funds Transfer – Central Contractor Registration (OCT 2003), all payments made under this contract shall be made using electronic funds transfer. The Contractor shall provide the following information to the Food and Drug Administration, Office of Financial Management, Contracts Invoice Payments, HFA-720, 12345 Parklawn Drive, Rockville, Maryland 20857 no later than 14 days prior to submission of the first invoice:

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).

G.3.2 An electronic copy shall be emailed to the attention of the designated Contract Specialist at the following address:

______._______@fda.hhs.gov The Contractor shall furnish the following minimum information on the invoice:

To constitute a proper invoice, the invoice must be submitted on company letterhead and include:

1. Name and address of the contractor.

2. Invoice date and invoice number.

3. Contract number.

4. Description, quantity, unit of measure, unite price and extended price supplies delivered or services performed.

5. Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading.

6. Terms of any discount for prompt payment offered.

7. Name and address of official to whom payment is to be sent (must be the same as that in the contract or in a proper notice of assignement.

8. Name, title, and phone number of person to notify in event of defective invoice.

9. Taxpayer identification number (TIN).

10. Electronic funds transfer (EFT) banking information.

11. Name and telephone number of the FDA COTR reference on the purchase order.

12. Any other information or documentation required by the contract.

An electronic invoice is acceptable if submitted in Adobe Acrobat (PDF) format. All items listed in 1-12 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.

Questions relating to when payment will be received should be directed to the FDA Payment Office at (301) 827-3742.

G.4 Ordering Procedures G.4.1 Any services to be furnished under the indefinite quantity portion of this contract shall be ordered by issuance of Task Orders. Such orders may be issued during the contract period only. The Contracting Officer may issue Task Orders and they shall be written on Form OF 347. Such orders will specify the quantity of services ordered, unit price, discount (if any), and other pertinent information.

G.4.2 The Contracting Officer is the only person authorized to issue Task Orders in connection with this contract.

G.4.3 Content of Order: Each task order placed under this contract shall include the following minimum 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 amount, and reporting requirements.

3. Delivery or performance date.

4. Place of performance.

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.

G.5 HHSAR 352-270.5 Key Personnel (JAN 2006) The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the contractor or Government.

Name

Title

G.6 Changes to Statement of Work Any changes to the SOW shall be authorized and approved only through written correspondence from the Contracting Officer. Costs incurred by the Contractor through the actions of parties other than the Contracting Officer shall be borne by the Contractor.

SECTION H - SPECIAL CONTRACT REQUIREMENTS tc " H - SPECIAL CONTRACT REQUIREMENTS " tc "H.1 FDA 1300 SECTION H - SPECIAL CONTRACT REQUIREMENTS " \l 2 H.1 Advanced Understanding

Notwithstanding any of the above provisions, under certain circumstances, the Government may be required to share data or information it obtains under this contract with Congress, with a Federal court, or with another governmental body of competent jurisdiction. If it intends to share data or information obtained under this contract with Congress, with a Federal court, or with another governmental body of competent jurisdiction, the Government will take appropriate measures within its control in an effort to ensure that the information will be shared in a manner intended to protect the information from public disclosure.

Offerors submitting proposals to perform work under this contract must assure the protection of the information and data they receive under this contract from unauthorized use or disclosure, and must treat the information as confidential or otherwise privileged.

H.2 Smoke-Free Environment tc "H.2 FDA 1343 Smoke-Free Environment " \l 2 The Department of Health and Human Services is the Federal Governments principal agency for furthering the health of Americans and providing them with essential human services. The health risks of smoking and exposure to smoke are clearly documented by reports of the Surgeon General. It is essential that the Department, in the accomplishment of its mission, provide a smoke-free environment in all HHS owned and leased building space.

It is, therefore, the Departments policy to establish a smoke-free environment in all HHS building space. All HHS owned and leased building space is designated as no-smoking areas. This policy applies to Government employees as well as Contractor employees who are assigned to work at HHS owned or leased building space.

H.3 FDA 1335 Personnel Security Clearance Requirements

1. BACKGROUND

The Office of the Assistant Secretary for Management and Budget, Department of Health and Human Services (DHHS), requires that DHHS employees and contractor employees (including subcontractors) who will be working in a DHHS-owned or leased space and/or who will have access to DHHS equipment, and non-public privileged, proprietary, or trade secret information, undergo a background investigation of some type.

Contractor employees who will be in DHHS-owned or lease space for less than thirty (30) days are exempted from the background investigation requirement. These contractor employees must be escorted at all time while in DHHS-owned or leased space.

2. GENERAL

The contractor shall submit the following items to the Contracting Officer, ten (10) calendar days prior to commencement of work under this contract:

a. Certification that all required security form packets and a list of contractor employees names for whom the requisite security information has been provided to Division of Security Operations, Policy and Planning, Personnel Security Staff.

b. "Contractor's Commitment to Protect Non-public Information Agreement" forms signed by each employee named in paragraph a. above.

With the exception of costs associated with fingerprinting Contractor employees outside of the FDA Personnel Security Office, the Government will conduct all required background investigations at no cost to the contractor. The cost of fingerprinting Contractor employees at any location other than the FDA Personnel Security Office will be borne by the Contractor.

Contractor employees shall obtain security badges in order to access to DHHS-owned or leased property without an escort. (See Section 3 for details on the badging process) However, in the event that work must commence before security badges can be issued, contractor employees will be allowed onto DHHS-owned or leased property, but must be escorted at all times.

All Contractor employees who undergo a background investigation are required to log onto the Office of Personnel Management’s (OPM’s) Electronic Questionnaire for Investigation Processing (e-QIP) system to complete the forms necessary to initiate their background investigations. The forms required vary with the position risk levels for the contract.

The position risk levels for this contract are Level 5.

There are two (2) potential position risk levels, which are:

a. Non-Sensitive Positions (Level 1) (SEE CHART A) - Positions which involve the lowest degree of adverse impact on the efficiency of the Agency. The forms set forth by CHART A are required for Non-Sensitive Positions (Level 1). Contractor employees assigned to Level 1 who receive a security badge will be required to provide additional security information for a background investigation as specified in Paragraph 5 below.

b. Public Trust Positions (Levels 5 or 6) (SEE CHART B) - Positions in which the incumbent's actions or inaction could diminish public confidence in the integrity, efficiency, or effectiveness of assigned Government activities, whether or not actual damage occurs. The forms set forth by CHART B are required for Public Trust Positions (Levels 5 or 6). Contractor employees assigned Levels 5 or 6 must receive security badge as well as a background investigation.

In order to access the e-QIP system, Contractor employees must provide the appropriate Personnel Security Specialist with the following information: (a) full name; (b) position title; (c) social security number; (d) date of birth; (e) place of birth; (f) email address; and (g) phone number. The Personnel Security Specialist will use this information to initiate each Contractor employee into the e-QIP system. Once this is done, each Contractor employee will receive an email that contains a web link to access the e-QIP system, as well as instructions and additional forms needed to initiate the suitability background investigation. The Project Officer for the contract will provide the name of the appropriate Personnel Security Specialist to the Contractor.

A Contractor’s failure to comply with the e-QIP processing guidelines will result in that Contractor’s employees being denied access to FDA property until all security processing has been completed.

3. BADGING PROCESS

The FDA Project Officer will sponsor Contractor employees on the FDA Form 3391 for the purpose of obtaining an FDA Security Access Card. In order to obtain one, a contractor employee must receive a “favorable” fingerprint return. Fingerprints must be submitted to the Personnel Security Office at least ten (10) days prior to the commencement of work. Fingerprints will be submitted in one of two ways, depending on where the contract will be performed:

a. Contractor employees who will work in the Washington D.C. metro area will, at the direction of the FDA Project Officer or his/her designee, contact the Personnel Security Branch to schedule a fingerprinting appointment, or

b. Contractor employees who will work in a field office will submit fingerprints to:

Food and Drug Administration

Fingerprinting and Personnel Security Office

10903 New Hampshire Avenue, Building 1, Room 1201

Silver Spring, MD 20993

Upon the receipt of a “favorable” fingerprint return, each Contractor employee must present two forms of identification in order to receive his or her badge. One form of identification must be a government-issued photo identification document. Acceptable forms of photo identification are referenced on the FDA Form 3391. Acceptable forms of secondary identification are listed on the back of the I-9 Form. This form can be obtained at http://uscis.gov/graphics/formsfee/forms/files/i-9.pdf An individual who receives an unfavorable report may appeal that finding by submitting a written request to the Personnel Security Staff.,

4. BACKGROUND INVESTIGATIONS

The Government shall conduct an additional background investigation for those individuals named to risk Levels 1, 5 and 6 serving under this contract.

Required background investigations may include, but not be limited to:

· Review of prior Government/military personnel records;

· Review of FBI records and fingerprint files;

· Searches of credit bureaus;

· Personal interviews; and

· Written inquiries covering the subject's background.

Background investigations will be conducted by the Office of Personnel Management (OPM).

The Contractor is responsible for ensuring that the integrity of contract performance is maintained pending completion of all appropriate background investigations of contractor employees.

The Contractor shall submit the information required for eQIP access and other requisite forms for the risk level(s) specified. In addition, the contractor shall provide a cover letter which includes: the Contractor's name, the contract number, the name of the Contracting Officer administering the contract, the names of all Contractor employees' for whom a background check is required and those employees’ social security numbers, dates of birth, and former names. This cover letter and all completed forms shall be transmitted, in a separate sealed envelope marked, "TO BE OPENED BY ADDRESSEE ONLY," to:

Food and Drug Administration

Badging and Credentialing Office

10903 New Hampshire Avenue, Building 1, Room 1201

Silver Spring, MD 20993

The contractor shall send a separate letter to the Contracting Officer that includes the contract number and employee names.

The contractor shall advise its prospective employees that all standard forms submitted to the FDA will be forwarded to the Office of Personnel Management (OPM) for scheduling background investigations.

Personnel Security Staff will resolve with the contract employee any issues arising out of inaccurate or incomplete forms.

Employees who have been previously granted a Government security clearance shall advise Personnel Security Staff of the details of such clearances to determine if a previous clearance level is suitable for the current FDA position.

At any time, if a contractor employee for whom security forms have been submitted is terminated or otherwise ceases work under the contract, the contractor shall immediately notify Personnel Security Staff, in writing, with copies to the respective FDA Project and Contracting Officers.

The OPM background investigation will take approximately 120 days. The Contracting Officer will notify the Contractor in writing if an employee is denied a clearance. Those individuals who have been cleared by Personnel Security Staff may continue to work under the contract.