Solicitation Recovery ARRAOS 10-223-SOL-00105 100528.pdf

OMB No. 0990-0115

10-223-SOL-00105

SOLICITATION, OFFER AND AWARD

4. TYPE OF SOLICITATION2. CONTRACT NUMBER 3. SOLICITATION NUMBER

7. ISSUED BY CODE 8. ADDRESS OFFER TO (If other than Item 7)

ORDER UNDER DPAS (15 CFR 700)

6. REQUISITION/PURCHASE NUMBER

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

NEGOTIATED (RFP)

SEALED BID (IFB)

5. DATE ISSUED

1. THIS CONTRACT IS A RATED RATING PAGE OF PAGES

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C. E-MAIL ADDRESS

EXT.NUMBERAREA CODE

B. TELEPHONE (NO COLLECT CALLS)A. NAME

10. FOR

INFORMATION

CALL:

CAUTION: LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

(Date)(Hour) local timeuntildepository located in copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if hand carried, in the

SOLICITATION

9. Sealed offers in original and

PART IV - REPRESENTATIONS AND INSTRUCTIONS

OTHER STATEMENTS OF OFFERORS

EVALUATION FACTORS FOR AWARD

INSTRS., CONDS., AND NOTICES TO OFFERORS

REPRESENTATIONS, CERTIFICATIONS AND

LIST OF ATTACHMENTS

CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

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M SPECIAL CONTRACT REQUIREMENTS

CONTRACT ADMINISTRATION DATA

DELIVERIES OR PERFORMANCE

INSPECTION AND ACCEPTANCE

PACKAGING AND MARKING

DESCRIPTION/SPECS./WORK STATEMENT

SUPPLIES OR SERVICES AND PRICES/COSTS

SOLICITATION/CONTRACT FORM

PART II - CONTRACT CLAUSESPART I - THE SCHEDULE

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SEC. DESCRIPTION PAGE(S) (X) DESCRIPTION SEC. (X)

11. TABLE OF CONTENTS

18. OFFER DATE17. SIGNATURE

SUCH ADDRESS IN SCHEDULE.

IS DIFFERENT FROM ABOVE - ENTER

15C. CHECK IF REMITTANCE ADDRESS

EXT.NUMBERAREA CODE

15B. TELEPHONE NUMBER

(Type or print)AND

ADDRESS

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OFFEROR

CODE FACILITY

16. NAME AND TITLE OF PERSON AUTHORIZED TO SIGN OFFER15A. NAME

DATEAMENDMENT NO.DATEAMENDMENT NO.

and related documents numbered and dated):

amendments to the SOLICITATION for offerors

(The offeror acknowledges receipt of

14. ACKNOWLEDGEMENT OF AMENDMENTS

CALENDAR DAYS (%)30 CALENDAR DAYS (%)20 CALENDAR DAYS (%)10 CALENDAR DAYS (%)

(See Section I, Clause No. 52.232.8)

13. DISCOUNT FOR PROMPT PAYMENT

designated point(s), within the time specified in the schedule.

by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the

12. In compliance with the above, the undersigned agrees, if this offer is accepted within ______________ calendar days (60 calendar days unless a different period is inserted

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

OFFER (Must be fully completed by offeror)

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

28. AWARD DATE

(Signature of Contracting Officer)

27. UNITED STATES OF AMERICA

25. PAYMENT WILL BE MADE BY

26. NAME OF CONTRACTING OFFICER (Type or print)

CODE 24. ADMINISTERED BY (If other than Item 7)

ITEM

(4 copies unless otherwise specified)

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

41 U.S.C. 253 (c) ( 10 U.S.C. 2304 (c) (

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION20. AMOUNT19. ACCEPTED AS TO ITEMS NUMBERED

AWARD (To be completed by government)

CODE

107030405/28/2010 X

HFA-322

DHHS/FDA/OSS

ATTN: OFFAS - ACQUISITION SERVICES

(NCTR)

3900 NCTR ROAD

JEFFERSON AR 72079

1600 CS 06/28/2010

AARON A GLAZIER

AARON.GLAZIER@FDA.HHS.GOV

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PAGE(S)

AARON A. GLAZIER

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is unusable

STANDARD FORM 33 (Rev. 9-97)

Prescribed by GSA - FAR (48 CFR) 53.214(c)

1-2 3-4

5-13 16-17 18-27 28-52

53-69

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90-97

OMB No. 0990-0115

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

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CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

10-223-SOL-00105

(A) (B) (C) (D) (E) (F)

5-year IDIQ Contract FDA Legacy Data Conversion

Service

Delivery: 09/30/2015

Delivery Location Code: WO21

White Oak Campus, Building 21

The US Food and Drug Administration

10903 New Hampshire Avenue

Building 21

Silver Spring MD 20993 US

FOB: Destination

1 FDA Legacy Data Conversion Services to be performed in accordance with the Statement of

Work.

OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

NSN 7540-01-152-8067

RECOVERY ARRAOS: 10-223-SOL-00105

Legacy Data Conversion

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FOOD AND DRUG ADMINISTRATION-CENTER FOR DRUG EVALUATION

AND RESEARCH

SECTION B: SUPPLIES OR SERVICES / PRICES AND COST

B.1 Brief Description of Services

Legacy study data that currently resides at FDA in a myriad of different formats shall be converted into an electronic uniform standard structure to facilitate answering important scientific and regulatory questions of interest to promote the public health. The requirement will provide services to convert legacy study data into a standard format identified by FDA.

FDA has determined it to be in its best interest to utilize an IDIQ contract to reduce lead time in awarding task orders and to maximize the flexibility of selecting contract types appropriate to the specific tasks under consideration.

The contract will have an ordering period of 5 years. At the discretion of the Contracting Officer, the government may use a variety of task order types under this contract, including, but not limited to: Firm Fixed Price (FFP), Time and Materials (T&M), Labor Hours (LH), or a combination thereof.

Each Request for Task Order Proposal (RFTOP) issued under this contract will identify the Government’s determination of contract type for that specific order.

B.2 Cost/Price Schedule

ITEM

NO

SUPPLIES/SERVI

CES

MAX

QUANTITY

UNIT UNIT PRICE MAX AMOUNT

0001 TBD Dollars, U.S.

$1.00 NTE $

ORDERING PERIOD

Legacy Data Conversion Services to be performed for FDA in accordance with requirements as identified in the Statement of Work. Task orders may be FFP, T&M, or LH (to be identified at Task-Order Level)

MAX

NET AMT

B.3 The maximum dollar value for Contract Line Item 0001 as set forth above is the total ceiling amount for the duration of the contract. There is no annual ceiling amount. The total

- 4 -ceiling amount for the entire ordering period is $X,XXX.XX. The maximum ceiling amount is not subject to change.

B.4 As referred to in paragraph (b) of FAR 52.216- 22, INDEFINITE QUANTITY clause, the contract minimum quantity is the amount of the seed task (which becomes the first task order and is issued immediately upon execution of the contract). The maximum quantity shall not be exceeded except as may be provided for via formal modification to the contract.

B.5 Firm Fixed Price, Labor Hour, Time and Materials Tasks – Overview

The SOW found in section C of this contract provides a general overview of the various tasks that may be required in the performance of the contract. The exact number of data sets, types of data that will need to be converted, and to which formats cannot currently be determined for the entire five year ordering period. For this reason, the Government reserves the right to issue future task orders as Firm Fixed Price Orders, Labor Hour Task Orders, or Time and Materials Task Orders, depending on the size, scope, and complexity of the data that needs to be converted.

See section G.10 for information on how the FDA intends to definitize its requirements for services ordered through task orders.

(The schedule below will be completed upon contract execution. The fully-burdened hourly labor rates proposed by the Contractor will remain fixed for the duration of the contract and are not subject to change). These rates will serve as the rates that the Contractor bills for should a labor hour or Time and Materials Task Order be issued. The Contractor will also use these rates when creating a proposal for a FFP task order, in which case only the appropriate labor mix and number of hours needs to be negotiated.)

Schedule of Labor Categories/Rates

Year 1 Year 2 Year 3 Year 4 Year 5 Labor Category Rate Rate Rate Rate Rate

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SECTION C: STATEMENT OF WORK

FDA Legacy Data Conversion

Statement of Work

Background:

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices and our nation’s food supply. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

FDA promotes, protects and enhances the health of the public through product development, evaluation and continued safety monitoring throughout the product’s life cycle. Thus, the FDA has accumulated a vast collection of study (clinical and nonclinical) data. Under the Critical Path Initiative (CPI) mandate, FDA is modernizing the tools and processes to turn scientific and technological discoveries into medical advances that leverage prior knowledge. Janus is an Agency-wide program that was approved by the Bioinformatics Board and aims to improve how FDA manages structured scientific data about regulated products. The goal of the Janus program is to improve science-based, regulatory decision-making through better access to structured scientific data about FDA regulated products. The ultimate outcome will be safer, more effective and higher quality products.

Currently, a systematic analysis of data from across various trials is painstakingly difficult, if not impossible, because the data from these studies have been submitted to the Agency in various non-standardized structures and formats, and is often paper-based. To facilitate meta-analysis across multiple studies, certain legacy study data that reside at FDA need to be converted into an electronic uniform standard structure to facilitate answering important scientific and regulatory questions of interest to promote the public health.

1. Scope

The contractor shall provide technical support and advice to convert legacy study data and metadata into standardized structured electronic datasets in a timely and cost-effective manner.

To this end, the Contractor shall provide data management specialists, biostatisticians, epidemiologists, statistical programming, clinical informaticists, and other expertise as necessary to advise on the details of particular data standards of interest and complete legacy data conversion services to deliver standardized datasets.

It is anticipated that there will be multiple task orders with different needs and requirements for conversion of legacy data to particular standards and/or formats. Each project will be carried

- 6 -out via the development of specific tasks under this contract as deemed necessary by the FDA.

These projects will be outlined in specific Task Orders.

2. Objectives

FDA will require the following overall services from the contractor:

A. Project Management: The contractor shall provide project management support for all tasks in the statement of work, including participation in regular status meetings and complying with specific reporting requirements outlined in the respective task orders

B. Data Conversion Services: The contractor shall provide services to convert legacy study data to a standard format identified by FDA (format to be identified in each task order and may include Clinical Data Interchange Standards Consortium (CDISC;

www.CDISC.org) Study Data Tabulation Model (SDTM), Standard for Exchange of Nonclinical Data (SEND), Analysis Dataset Model (ADaM), and the CDISC-HL7 (Health Level 7; www.HL7.org) standards). The contractor shall work with FDA to harmonize variable names and terminology as needed to allow analysis across multiple studies

C. Data Standards Support: The contractor shall support the advancement of current standards and support the development of new standardized values for domain data by ensuring alignment to the appropriate standard development organization (SDO; e.g.

CDISC, HL7).

D. Data Security Assurances: The contractor shall safeguard and process the data according to Federal and FDA circulars, directives, executive orders, guidelines and regulations.

3. Specific Tasks/Deliverables

The contractor shall provide data conversion services and expertise to convert legacy study data and metadata into standardized structured electronic datasets. In the task orders, the Contractor shall be required to do one or more of the following tasks (required data format and tasks will be specified at the task-order level):

A. Project Management:

• Provide project management support that ensures that the scope, performance, schedule, and cost are controlled and consistent with this contract.

• As stipulated in the task orders, provide the capability to plan, track, and report cost, schedule and performance for the effort required to convert applicable studies and associated datasets within each required therapeutic area.

• Comply with reporting requirements stipulated in the task orders.

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B. Data Conversion:

• Develop and use tools and processes to organize, standardize, transform, and validate the converted study datasets. The contractor shall specify the methods it will employ in accomplishing the key tasks identified.

• Develop and document a repeatable process for transforming legacy study data into a structured, electronic standardized format that will facilitate the loading of these datasets into a standardized database for use in cross-trial analysis.

• Provide data conversion expertise that may include data management specialists, biostatisticians, epidemiologists, statistical programming, clinical informaticist, SDO expert, and others as necessary to advise on the details of particular data standards and/or terminology of interest and complete legacy data conversion services.

• Provide a quality assurance plan to demonstrate that the delivered converted datasets will provide results consistent with those reported in the clinical study reports.

C. Data Standards Support

• Provide data conversion expertise with practical experience to support the development, understanding and implementation of the applicable standard or terminology (such as CDISC and HL7 Standards and/or disease specific terminology) with study data that may include both clinical and non-clinical data across a wide variety of therapeutic areas. It is expected that data conversion activities will use and may also inform available or emerging study data standards such as the Clinical Data Interchange Standards Consortium (CDISC; www.CDISC.org) Study Data Tabulation Model (SDTM), Standard for Exchange of Nonclinical Data (SEND), Analysis Dataset Model (ADaM), and the CDISC-HL7 (Health Level 7;

www.HL7.org) standards.

• Support the advancement of current standards/terminologies and support the development of new standardized values for domain data. If a recommendation or request for change to the standard is to be submitted to the SDO, the contractor shall submit the necessary supporting documentation to the task order COTR in compliance with the requirements of the standards organization(s).

D. Data Security Assurances:

• If a temporary data-sharing repository outside of the FDA is created during the conversion process to organize and control access to the scientific data, appropriate security requirements must be implemented, such as system access being limited to appropriate credentialing of authorized users, authority checks to verify that only authorized users can use the system to add, alter, delete and/or electronically sign a record.

• Information systems or applications that are purchased or developed to store or process federal information shall comply with Federal and FDA circulars, directives, executive orders, guidelines and regulations.

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• A complete list of all security-related guidelines and security-related standards that the Contractor’s system(s) must conform to are referenced in section H.15 of the contract.

• All systems or applications that will process or store federal information shall be certified and accredited with an Authorization to Operate (ATO) by the FDA Designated Approval Authority (DAA) prior to system operation. FDA DAA will contact awardee to coordinate certification and accreditation process of Contractor systems in accordance with NIST NIST SP 800-37, Revision 1, Guide for the Security Certification and Accreditation of Federal Information Systems, February 2010 and other regulations listed in section H.15.

4. Assumptions or Constraints

• On certain task orders, FDA Subject Matter Experts (i.e. FDA Reviewers) may be available to work with the contractor. The contractor shall request assistance from the SMEs with sufficient lead time to allow appropriate government response. Additionally, the Government shall make the final determination of whether or not SMEs are needed and available to provide assistance to the Contractor.

• When appropriate, the Task Order COTR may provide the government furnished materials at the appropriate time. The contractor shall request and create an inventory of the materials that will be necessary for the data conversion service. These materials may include legacy datasets in an electronic format such as transport files (SAS.XPT), SAS datasets (sas7bdat, sd2) and/or Microsoft Excel files (XLS or CSV) and background materials such as study protocols, statistical analysis plan, study reports, case report forms, and data definition files [define.pdf for non-SDTM files]).

• Communication with various Standards Development Organizations (SDOs) (e.g., CDISC, HL7) may be necessary in cases where the developing standard does not contain the appropriate domains, variables, terminology or other information to accommodate the legacy data being converted. The Contractor shall work through the task order COTR if communication with an SDO is necessary. If a recommendation or request for change to the standard is to be submitted to the SDO, the contractor shall first submit the necessary supporting documentation to the task order COTR in compliance with the requirements of the standards organization(s).

• The overall success of this data conversion service depends on the appropriate and consistent implementation of the particular data standard/format. Thus, it is assumed that the Contractor has or will provide the data conversion and data standard/format expertise (i.e., clinical informaticist, SDO expert) to support the specific implementation of the standard/format and feedback back to the appropriate SDO. The specific standard or format that data will be converted to, will be identified in each task order SOW.

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• Where there are standards validation tools available for contractor use (e.g., OpenCDISC validation tool), the Contractor shall pre-validate and correct (to the extent feasible without changing source data) converted legacy datasets.

• The following information is available for the data conversion process

a. Source data provided in electronic format. This includes datasets in SAS transport files (SAS.XPT), SAS datasets (sas7bdat, sd2) and/or Microsoft Excel files (XLS or CSV).

b. Protocol

c. Statistical Analysis Plan (SAP)

d. Clinical Study Report (CSR)

e. Data definition files [define.pdf for non-SDTM files]

f. Case report form (CRF), if available

g. Final blank CRF, if available

h. Final blank CRF annotated to source datasets, if available

• Assume that datasets received from Government originates from clinical trial data submitted to the Agency in support of regulatory actions.

• Assume all data is final, clean and locked since it was part of regulatory submission.

• Assume datasets contain meaningful, descriptive variable names and labels.

5. Reporting Requirements and Deliverable Items

The Contractor shall submit the following deliverables or outputs to the contract COTR.

Additional task Order-specific deliverables and reporting requirements will be specified in each task order.

a. Project Management Plan – The Contractor shall furnish a project management plan that describes the overall technical and management approach for the overall IDIQ and any subsequent task orders. The plan will be an on-going document as more task orders are awarded; however the initial plan shall be due 30 calendar days after award and updated as part of the task order reports.

b. Enterprise Performance Life Cycle (EPLC) - All activities/tasks performed under this contract shall be monitored and managed in accordance with IT best practices defined in the Health and Human Service Enterprise Performance Life Cycle (EPLC) guidance document. Applicable artifacts that may be required by specific task orders include (but are not limited to) Schedule, System Requirements Specification, System Design Document (includes Data Dictionary and Interface Control Document), Master Test Plan, Test Cases Specifications, and System Test Report. It is the contractor’s responsibility to identify the applicable artifacts for each task order.

c. Earned Value Project Management – Although not anticipated, should a time and material or labor hour task order be issued, the contractor shall submit a detailed cost and schedule baseline for completion of the effort described in the Statement of Work for the

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Task Order no later than 10 days after the RFP for that task order was issued. Included in this schedule shall be a set of discrete-event project milestones to which the budget will be apportioned. To the greatest extent possible, these milestones shall be tied to the beginning and/or completion of specific activities and/or accomplishments (deliverables, formal meetings/reviews, etc) vice simple Level of Effort (i.e passage of time) and have a duration of 30 days or less (due to the monthly reporting cycle). For any activities requiring more than 30 days to complete, the contractor shall develop reasonable lower-level activities with “progress milestones” which can be used for each reporting period.

In planning this baseline, it is vital that the contractor assign appropriate resources to each activity such that the Government can accurately assess real progress and compare this to the original baseline.

The contractor will be required to submit monthly cost and schedule progress reports.

The contractor will submit cost and schedule data by labor category according to the following Work Breakdown Structure (WBS):

- Project Management o Plan/Schedule (approval required) o Ongoing Reporting

- Data Conversion o Plan (approval required) o Ongoing Metrics Tracking and reporting (ties to PM reporting)

- Study Data Conversion (x N Studies) o Approach (approval required) o Conversion including converted data

- Study Data Integration (x M Integrated DataSets) o Approach (approval required) o Integrated Datasets delivered

For each element in the WBS, the contractor shall provide the following data for both the current reporting period and the cumulative totals to date:

- Budgeted Cost of Work Scheduled (BCWS) – The total budgeted cost for the work scheduled to be completed as of the end of the reporting period. This value must align to the baseline schedule.

- Budgeted Cost of Work Performed (BCWP) – The total budgeted cost for the work actually accomplished as of the end of the reporting period. This value must align to the baseline cost.

- Actual Cost of Work Performed (ACWP) – The total cost of work actually performed as of the end of the reporting period.

- Schedule Variance – Computed by subtracting BCWS from BCWP. This is an indication of schedule performance in relation to the initial task order baseline.

- Schedule Variance % - Computed by dividing Schedule Variance by BCWS.

- Cost Variance – Computed by subtracting ACWP from BCWP. This is an indication of cost performance in relation to the initial task order baseline.

- Cost Variance % - Computed by dividing Cost Variance by BCWP.

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For each element in the WBS which has a cost or schedule variance of greater than ±10%, the contractor shall include a report explaining the reason for the variance, any planned remediation, and any expected impact to the overall task order budget and/or schedule as part of the monthly progress report.

If at any time during the task order the contractor determines it is necessary to modify the original baseline, the proposed modification shall be submitted to the Government for approval. The contractor shall provide/report according to only approved baseline modifications in the monthly progress reports.

d. Monthly Progress Reports – The Contractor shall furnish progress reports each month during contract performance detailing the current status of all subtask activities taking place during the reporting period. The report shall be in narrative/tabular form and shall include a summary of progress toward completion, of any work in progress, problems encountered to date, and the Contractor’s assessment of the impact of such problems on estimated cost and schedule. The monthly report shall include shall include a financial statement showing all costs incurred to date. Based on task order requirements, costs incurred shall be reported by category of expenditure (with enough detail to track the costs for converting study datasets within each therapeutic area).

e. Comprehensive repository- The Contractor shall maintain a comprehensive repository of all contract documentation in an eRoom or elsewhere as directed by the Contracting Officers’ Technical Representative (COTR).

f. Data conversion plan- The Contractor shall present a process for mapping the data to the applicable standard/format, including domains to be included in the transformation and terminologies that may need to be harmonized.

g. Converted datasets plan- The contractor shall deliver draft and final validated datasets with accompanying define.xml file as agreed to in the task order.

h. Additional reporting requirements- If specified at the task order level, the contractor shall comply and complete in a timely manner with all specific reporting requirements stipulated by the American Reinvestment and Recovery Act (ARRA) in the Federal Acquisition Regulations (FAR) Part 4.15.

i. Final Report – The Contractor shall provide a narrative final report documenting significant work activities for the preceding performance period. This report shall provide a historical record of major work activities and accomplishments; the report shall be objective and include recommendations that might enhance future work. The final report shall clearly separate the progress for all subtasks within the report.

j. System Security Plan – The contractor shall develop and deliver a system security plan (SSP) as part of the first task order and provide updates to the SSP if necessary as part of

- 12 -subsequent task orders. Details for the delivery of the SSP will be included in the Task Order(s).

k. The contractor shall develop and deliver a Media Sanitation Plan in accordance with NIST SP 800-88, Revision 1 as part of the first task order and provide updates to the SSP if necessary as part of subsequent task orders. Details for the delivery of the SSP will be included in the Task Order(s).

6. Government Furnished Property (GFP)

See Section H.17 regarding GFP

7. Quality Assurance

In order to facilitate the Government’s inspection and acceptance process, the contractor shall implement and maintain a quality assurance system to ensure the product integrity of all deliverables meets or exceeds the requirements established in this SOW. General quality measures, as set forth below, shall be applied to each work product received from the contractor under this statement of work:

• Content-Work products shall be inclusive of all items mentioned in the objectives and scope along with content identified in (or by) the assessments.

• Accuracy - Work Products shall be accurate in presentation, technical content, and adherence to accepted elements of style.

• Clarity - Work Products shall be clear and concise. Diagrams and graphics shall be clearly defined and be relevant to the supporting narrative.

• Consistency to Requirements - Work products must satisfy the requirements of this statement of work.

• File Editing - Text and diagrammatic files shall be editable by the Government.

• Format - Work Products shall be submitted electronically and in media mutually agreed upon prior to submission.

• Timeliness - Work Products shall be submitted on or before the due date specified in this statement of work or submitted in accordance with the scheduled date determined by the Government.

8. Notice to Government of Delays

In the event the Contractor encounters difficulty in meeting performance requirements, or when the Contractor anticipates difficulty in complying with the contract delivery schedule or completion date, or whenever the Contractor has knowledge that any actual or potential situation is delaying or threatens to delay the timely performance of this contract, the Contractor shall immediately notify the Contracting Officer and Project Officer in writing, giving pertinent details. This data shall be informational in nature and this provision shall not be construed as a waiver by the Government of any delivery schedule or date, or any rights or remedies provided by law or under this contract.

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SECTION D: PACKAGING AND MARKING

D.1 PREPARATION FOR DELIVERY

All material to be delivered hereunder shall be afforded the degree of packaging (preservation and packing) required to prevent deterioration and damages due to the hazards of shipment, handling and storage. Best commercial practice will be accepted.

D.2 MARKING OF SHIPMENTS (DATA AND MATERIALS)

Each shipment of data hereunder by other than electronic means shall be marked as specified in individual delivery orders, as applicable.

D.3 PROHIBITED PACKAGING MATERIALS

The use of asbestos, excelsior, newspaper or shredded paper (all types including waxed paper, computer paper and similar hygroscopic or non neutral material) is prohibited. In addition, loose fill polystyrene is prohibited for shipboard use.

D.4 PACKAGING, MARKING, AND SHIPPING

Unless specified otherwise at the task order level, all deliverables relating to this requirement shall be delivered to the following individual:

To be identified at time of award

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SECTION E: INSPECTION AND ACCEPTANCE

E.1 INSPECTION AND ACCEPTANCE - DESTINATION

Inspection and acceptance of the services and deliverables to be furnished hereunder shall be made at destination by the Contracting Officer’s Technical Representative (COTR). Unless otherwise designated in individual task orders, the COTR shall provide written notification of the acceptability of services and deliverables to the Contracting Officer within ten days after the completion of services or the receipt of deliverables.

E.2 ACCEPTANCE

The performance and quality of work delivered by the contractor, including services rendered and any documentation or written material compiled shall be subject to inspection, review, and acceptance by the Government. Acceptance will be based on FDA’s review and validation of the converted datasets based on the data standard used during the conversion process.

CLAUSES INCORPORATED BY REFERENCE

52.247-34 F.O.B. Destination NOV 1991 52.246-4 Inspection of Services-Fixed Price AUG 1986 52.246-6 Inspection of Services-Time-and-Material and Labor-

Hour

MAY 2001

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SECTION F- DELIVERIES OR PERFORMANCE

F.1 CONTRACT PERIOD OF PERFORMANCE

The contract period of performance for the IDIQ contract begins the date of contract award execution. The ordering period of the IDIQ contract will be 5 years from the date of award.

CLIN No: Period Period of Performance 0001 Ordering Period XX/XX/2010-- XX/XX 2015

Each task order will identify a period of performance specific to the individual task order.

F.2 CONTRACTOR NOTICE REGARDING LATE DELIVERY

In the event the contractor, for any reason, anticipates or encounters difficulty in complying with the contract delivery schedule or performance date or in meeting any of the requirements of the contract or one of its task orders, the contractor shall immediately provide written notification to the Contracting Officer, via the cognizant Contract Administration Service Office, if assigned, giving pertinent details. This data shall be informational in character and its receipt by the Government shall not be construed as a waiver by the Government of (a) any delivery schedule or date or (b) compliance with other requirements by the contractor or (c) any other rights or remedies provided to the Government by law or under this contract.

F.3 PLACE OF PERFORMANCE

The primary place of performance will be at the contractor’s facility. However, the Contractor shall frequently be required to attend meetings at the FDA White Oak Campus located at 10903 New Hampshire Ave, Silver Spring, MD.

F.4 HOURS OF OPERATION:

It is expected that the Contractor shall maintain continuous service between 8:00 a.m. and 5:00 p.m. Eastern Time, Monday through Friday, excluding Federal holidays and building closures.

Performance during this time is desired as it will facilitate communications between the Contractor and FDA technical personnel.

The FDA reserves the right to visit contractor facilities (offsite) during regular business hours.

FDA Project Officers/COTRs will coordinate visits at their discretion.

F.5 OBSERVANCE OF FEDERAL HOLIDAYS & OTHER GOVERNMENT CLOSINGS:

No services or deliveries shall be performed at the Federal sites on Federal legal holidays as shown below unless specifically requested by the Contracting Officer.

1. New Year’s Day January 1st

2. Martin Luther King Day Third Monday in January

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3. President’s Day Third Monday in February

4. Memorial Day Last Monday in May

5. Independence Day July 4th

6. Labor Day First Monday in Sept.

7. Columbus Day Second Monday in Oct.

8. Veteran’s Day November 11

9. Thanksgiving Day Fourth Thursday in November

10. Christmas Day December 25

CLAUSES INCORPORATED BY REFERENCE

52.242-15 Stop-Work Order AUG 1989 52.247-34 F.O.B. Destination NOV 1991

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SECTION G: CONTRACT ADMINISTRATION DATA

G.1 CONTRACT TYPE

As contemplated in Section L solicitation provision FAR 52.216-1 “Type of Contract (APR 84),” the Government intends to award an Indefinite Delivery Indefinite Quantity type contract with subsequent task orders being issued on a Fixed Price, Labor-hour, or Time and Materials basis, or a combination thereof. The contract type of each task order will be identified in the Request for Task Order Proposal (RFTOP) for each order.

G.2 ACCOUNTING AND APPROPRIATION DATA

Funds will not be obligated on the basic contract. Funds will be identified at the task order-level at the time of task order award.

G.3 AUTHORIZED CHANGES ONLY BY THE CONTRACTING OFFICER

(a) Except as special in paragraph (b) below, no order, statement, or conduct of Government personnel who visit the Contractor’s facilities or in any other manner communicates with Contractor personnel during the performance of this contract shall constitute a change under the “Changes” clause of this contract.

(b) The Contractor shall not comply with any order, direction or request of Government personnel unless it is issued in writing and signed by the Contracting Officer, or is pursuant to specific authority otherwise included as a part of this contract.

(c) The Contracting Officer is the only person authorized to approve changes in any of the requirement of this contract and notwithstanding provisions contained elsewhere in this contract;

the said authority remains solely the Contracting Officer’s. In the event the contractor effects any change at the direction of any person other than the Contracting Officer, the change will be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in changes incurred as a result thereof. The address and telephone number of the Contracting Officer is:

NAME: Aaron A. Glazier – Contracting Officer

ADDRESS: Food and Drug Administration National Center for Toxicological Research Attention: Aaron Glazier, Contracting Officer Office of Field Acquisitions, HFT-320 3900 NCTR Road Building 50, Room 417 Jefferson, AR 72079-9502

Telephone: (870) 543-7577

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E-Mail: aaron.glazier@fda.hhs.gov

Authorized changes may also be made by other Contracting Officers if authorized in writing by the Contracting Officer. OAGS policy may also grant authority for others such as the Head of Contracting Activity or Division Directors to make such changes.

G.5 AUTHORIZED ORDERING OFFICERS

(a) The following activity(ies) or individual(s) is/are designated as Ordering Officers under this contract:

1) Any Contracting Officer of the U.S. Food and Drug Administration-Office of Acquisitions and Grants Services (OAGS); subject to the limitations contained in their respective contracting officer warrants (SF 1402, Certificate of Appointment).

2) Others as authorized in writing by the Contracting Officer.

(b) The above activity(ies) or individual(s) is/are hereby responsible for issuing and administering any task orders place hereunder. Ordering Officers may negotiate revisions/modifications to task orders but only within the scope of this contract. Ordering Officers have no authority to modify any provisions of the basic contract. Any deviation from the terms of the basic contract must be submitted to the Procuring Contracting Officer (PCO) for contractual action. Ordering Officers may enter into mutual no-cost cancellations of task orders under this contract and may reduce the scope of the task orders, but Terminations for Convenience or Terminations for Default shall be issued only by the PCO.

G.6 CONTRACT OFFICER TECHNICAL REPRESENTATIVE (COTR)

The following COTR will represent the Government for the purpose of this contract:

To be identified at time of award

Phone: (301)

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.

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The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to:

(1) direct or negotiate any changes in the statement of work;

(2) modify or extend the period of performance;

(3) change the delivery schedule;

(4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or

(5) otherwise change any terms and conditions of this contract.

The Government may unilaterally change its COTR designation.

G.7 KEY PERSONNEL

The following individuals have been identified by the Government as key personnel for this contract. Pursuant to HHSAR Clause 352.270-5, Key Personnel, incorporated in this contract, the following individual(s) is considered to be essential to the work being performed hereunder.

(To be completed at time of contract award)

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

G.8 POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

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In accordance with FAR 42.15, interim and final evaluations of contractor performance will be prepared on this contract. The final performance evaluation will be prepared at the time of completion of work of the final task order. In addition to the final evaluation, interim evaluations will be prepared annually to coincide with the anniversary date of the contract.

Interim and final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

Copies of the evaluations, contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

b. Electronic Access to Contractor Performance Evaluations

Contractors that have Internet capability may access evaluations through a secure Web site for review and comment by completing the registration form that can be obtained at the following address:

http://oamp.od.nih.gov/OD/CPS/cps.asp

The registration process requires the contractor to identify an individual that will serve as a primary contact and who will be authorized access to the evaluation for review and comment. In addition, the contractor will be required to identify an alternate contact that will be responsible for notifying the cognizant contracting official in the event the primary contact is unavailable to process the evaluation within the required 30-day time frame.

G.9 INVOICE SUBMISSION

The contractor shall submit monthly vouchers or invoices in accordance with the following clauses that are incorporated into this purchase order: 52.232-25, Prompt Payment (OCT 2003), and 52.232-33 Payment by Electronic Funds Transfer-Central Contractor Registration (OCT 2003)

These instructions provide for the submission of vouchers/invoices and personnel reporting required by HHSAR 342.7002.

1) Invoices/vouchers requests shall be submitted as follows

To be considered a "proper" invoice in accordance with FAR 32.9, Prompt Payment, each invoice shall clearly identify the ordering numbers that appear on the face page of the task orders as follows:

Order No. (This is the 17 digit number that appears in Block 1 or 2 of the SF-26 form)

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2) The contractor shall submit an original and two (2) copies of the invoice to the designated Contract Specialist at the following address:

Department of Health and Human Services Food and Drug Administration National Center for Toxicological Research Attention: Aaron Glazier, Contracting Officer Office of Field Acquisitions, HFT-320 3900 NCTR Road Building 50, Room 417 Jefferson, AR 72079-9502

The invoice must be submitted on company letterhead and include the following:

(I) Name and Address of the Contractor;

(II) Invoice Date and invoice Number;

(III) Purchase Order Number;

(IV) Description, Quantity, Unit of Measure, United Price and extended price supplies delivered or services performed;

(V) Shipping Number and Date of Shipment, Including the Bill of Lading Number and weight of shipment if shipment if shipped on Government Lading;

(VI) Terms of any Discount for Prompt Payment Offered;

(VII) Name and address of Official to whom payment is to be sent (Must be the same as that in the Purchase Order or in a notice of assignment);

(VIII) Name, Title, and Phone Number of Person to notify in event of effective invoice(s);

(IX) Taxpayer Identification number (TIN);

(X) Electronic funds Transfer (EFT) Banking information;

(XI) Name and Telephone Number of the FDA Project Officer Referenced on the Purchase Order; and

(XII) Any other information or documentation required by the purchase order;

*Electronic invoices are not accepted.

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The Contractor shall furnish the following additional information in support of costs submitted:

1. Period of Performance for which costs are claimed.

2. Number of record typed scan and their description

3. Travel costs, itemized and identified including origin and destination.

4. Any other supporting data that will clarify unusual expenditures.

The contractor shall include the costs for the current period and the cumulative costs for the total contract according to the categories shown above.

Each invoice shall include the routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited.

G.10 TASK ORDER PROPOSALS

The Section C Statement of Work is intended to describe the general scope of all the work that may be ordered under this contract. Only after the Contracting/Ordering Officer has ordered a specific FFP CLIN or only after the Contractor and Contracting Officer have negotiated a specific task order for a labor hour CLIN or T&M CLIN will an OF 347 be issued to the Contractor indicating the period of performance.

FDA will definitize and fund work under CLIN 0001 by issuing independent task orders against the IDIQ contract. These task orders will be bilateral. The task orders may be FFP, LH, or T&M. If the task order is of the LH or T&M variety, the task order award amount represents the ceiling/Not to Exceed amount. Each Request for Task Order Proposal (RFTOP) will clearly state whether the work performed on the resulting task order will be performed on a FFP, LH, or T&M basis. The Contractor’s proposal should be prepared and submitted accordingly using the labor rates identified in Section B.

The process for issuing a task order is as follows:

• The Contract Specialist will send the contractor a detailed RFTOP via email.

• The Contractor shall submit a proposal within seven (7) working days from the date of the request from the Contracting/Ordering Officer. The response period includes a three-day working window for the Contractor to forward written comments and questions.

• As a minimum, the Contractor shall include in its task order proposal:

A brief description of the technical approach, a listing of the labor categories and rates be used (in accordance with labor category schedule/rates table found in Section B.5, the number of estimated hours within each labor category, and a proposed ceiling price for

- 24 -the Task(s). A detailed breakdown of any proposed travel (airfare, rental car, gas food and lodging etc,) in accordance with FTR policies and rates.

Any other additional price and cost information requested by the Contracting/ordering Officer

• The FDA will evaluate the proposal to ensure that represents an effective an efficient solution to meet the FDA’s needs.

• If the FDA has questions or concerns the Contracting Officer will notify the contractor, and may ask for a revised proposal.

• Once the proposal is determined to be acceptable (both technically and financially), the Contracting Officer will send the task order to the Contractor for signature.

• Task Orders will include the following information:

o Date o Task Order Number o Accounting Information o SOW o Agreed upon labor mix o Ceiling price o Any terms, conditions, or instructions unique to the task order

• The contractor will sign the Task Order and return it to the Contracting Officer.

• The Contracting Office will sign the Task Order and send the fully executed modification to the contractor.

When the Contracting/Ordering Officer has determined a bona-fide urgency exists for the Government, the Contractor shall honor the Contracting/Ordering Officer’s request to expedite proposal submission and return a proposal to the Contracting/Ordering Officer within three (3) working days from the date of the request form the Contracting Officer/Ordering Officer.

G.11 DATA TO BE DELIVERED

Any working papers, interim reports, data given by the Government or first produced by the Contractor under the contract or collected or otherwise obtained by the Contractor under the contract, or results obtained or developed by the Contractor (subcontractor or consultants) pursuant to the fulfillment of this contract are to be delivered, documented, and formatted as directed by the Contracting Officer, or duly authorized individual.

In addition, information and/or data, which are held by the Contractor related to the operation of their business and/or institution and which are obtained without the use of Federal funds, shall be considered “PROPRIETARY DATA” and are not “subject data” to be delivered under this contract.

G.12 DISSEMINATION, PUBLICATION AND DISTRIBUTION OF INFORMATION

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Data and information either provided to the Contractor, or to any subcontractor or generated by activities under this contract or derived from research or studies supported by this contract, shall be used only for the purposes of the contract. It shall not be duplicated, used or disclosed for any purpose other than the fulfillment of the requirements set forth in this contract. This restriction does not limit the Contractor’s right to use data or information obtained from a non-restrictive source. Any questions concerning “privileged information” shall be referred to the Task Order Contracting Officer (TOCO).

Some data or information may require special consideration with regard to the timing of its disclosure so that preliminary findings which could create erroneous conclusions are not stimulated. Also, some data or information, which relate to policy matters under consideration by the Government, may also require special consideration with regard to the timing of its disclosure so that the open and vigorous debate, within the Government, of possible policy options is not damaged.

Any questions about use or release of the data or information or handling of material under task orders shall be referred to the Task Order COTR who must render a written determination to the Task Order Contracting Officer (TOCO).