Amendment 3 Attachment 3 Solicitation 75F40124R00002 BEST 3.pdf

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Section B ‐ Continuation of Standard Form (SF) 1449 The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2024‐05 effective May 22, 2024.

B.1 Invoice Submission

FDA Electronic Invoicing and Payment Requirements ‐ Invoice Processing Platform (IPP) (Jan 2022);

Addendum to SF1449 Block 18b.

(a) All Invoice submissions for goods and or services must be made electronically through the U.S.

Department of Treasury’s Invoice Processing Platform System (IPP) (see http://www.ipp.gov/vendors/index.htm).

(b) Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract, or the clause 52.212‐4 Contract Terms and Conditions‐Commercial Products and Commercial Services included in commercial items contracts. The IPP website address is:

https://www.ipp.gov.

(c)‐

(1) The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 – 5 business days of the contract award for new contracts or date of modification for existing contracts.

(2) Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973‐3131.

(3) The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

(4) If your company is already registered to use IPP, you will not be required to re‐register.

(5) If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

(d) Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

(e) Invoices that include cost‐reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts.

(1) At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

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*Direct Labor ‐ include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

*Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)‐ show rate, base and total amount;

*Consultants (if applicable) ‐ include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

*Travel ‐ include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

*Subcontractors (if applicable) ‐ include, for each subcontractor, the same data as required for the prime Contractor;

*Other Direct Costs ‐ include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and *Fee – amount as allowable in accordance with the Schedule and FAR 52.216‐8 if applicable.

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

(1) list of all invoices submitted to date under the subject award, including the following:

*Invoice number, amount, & date submitted *Corresponding payment amount & date received *Total amount of all payments received to date under the subject contract or order, and for definitized contracts or orders only:

*Total estimated amounts yet to be invoiced for the current, active period of performance.

(g) Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

(h) If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

(i) Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

(j) The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

(k) Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301‐827‐ERIC (3742) or toll‐ free 866‐807‐ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call‐in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When

75F40124R00002 Amendment 3 Page 5 of 67 emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

Be advised that FDA does not accept documents which contain the use of macros. When submitting documents via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e., email blocks, quarantine). Document submissions required throughout the award period(s) shall not have macro enabled functionality and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

B.1.2 Contract Type The Government intends to award a multiple‐award Indefinite‐Delivery Indefinite‐Quantity contract per FAR parts 12, and 16.5, for severable and non‐severable services.

At the discretion of the CO, the Government may use a variety of contract types when issuing Task Orders under this contract, including: Firm‐Fixed‐Price (FFP), Time and Materials (T&M), Labor Hour (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.

B.2 SERVICES AND PRICES‐ Addendum to SF1449, Blocks 19/20

B.2.1 Description of Services The U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) has a requirement for their Biologics Effectiveness and Safety (BEST) Initiative #3: Health Care Data Sources for Surveillance of Biologics (BEST 3). The Contractor shall perform work in accordance with Attachment 1 Statement of Work, terms, conditions, requirements set forth herein and inclusive of Attachments set forth in section D. The requirement is to: 1) provide FDA with de‐identified analytic study results from large‐scale United States (US) health care data of tens of millions of patients. Particularly including adjudicated administrative claims data but also electronic health records (EHR) data sources (if available) using a distributed data network which may use a common data model (CDM). The data sources shall provide longitudinal health care data (particularly adjudicated administrative claims) for participating patients and 2) provide access to full medical charts of patients whose health care data (particularly adjudicated administrative claims) are available for review, abstraction, and adjudication in the context of biologic products surveillance activities. Except as otherwise specifically provided herein, all property, equipment, supplies, facilities, personnel, and services required to perform the work called for shall be furnished by the Contractor.

B.2.2 Minimum and estimated Maximum quantities for IDIQ portion The one‐time guaranteed minimum amount for this contract is $10,000.00. This minimum shall be met through the issuance of one or more Task Orders. Funding for this minimum guarantee will be obligated against the base contract award. Should the Government not award a task order with an aggregate value meeting or exceeding the minimum guarantee within the contract’s period of performance, then the contractor must submit proof to the Contracting Officer Representative (COR) and once approved, the Government may pay the guaranteed minimum. If the contractor is issued a task order off the IDIQ, then the task order amount will be reduced by the minimum guarantee obligated on the IDIQ contract. The maximum contract amount, inclusive of the five (5) year ordering period under the contract is estimated not to exceed $75,000,000.00 though this ceiling can be increased via mutual agreement of the parties.

The estimated maximum anticipated under this contract is not intended to imply that it is an estimate of

75F40124R00002 Amendment 3 Page 6 of 67 the total services that will be required. The maximum amount in no way guarantees that the volume of purchases through this IDIQ will be higher or lower than the said estimate over the term of the IDIQ.

B.2.3 Period of Performance The period of performance for this IDIQ contract shall consist of five (5), one‐year ordering periods estimated to be:

Ordering period 1: September 30, 2024 through September 29, 2025 Ordering period 2: September 30, 2025 through September 29, 2026 Ordering period 3: September 30, 2026 through September 29, 2027 Ordering period 4: September 30, 2027 through September 29, 2028 Ordering period 5: September 30, 2028 through September 29, 2029

B.2.4 Order Period Task Orders may be issued up to the final day of this contract inclusive of any extensions thereto, and the contract shall remain in force to allow for the completion of all Task Orders issued. Task orders performance periods may go up to one year and six months past the IDIQ Ordering Period end date and labor rates shall remain at the last ordering period rates.

B.2.5 Pricing Schedule

LABOR CATEGORIES

Labor categories below required to support the system over the duration of the contract. If proposed labor categories are different, offerors should map their labor category titles to those in the pricing table.

Estimated not to exceed (NTE) costs will be provided at the Task Order level for Other Direct Costs (ODCs) and Materials. The Contractor shall not exceed the maximum loaded hourly direct labor rates for each category listed below.

The estimated hours and price in the table below are for evaluation purposes only. The fixed hourly rates shall include all direct labor cost, indirect labor cost, general and administrative cost and profit or fee.

Ordering period #1: (exact dates to be completed upon award)

No. Suggested Labor Category

Estimated Level of Effort

Fully Burdened Hourly Rate Total

1 Co‐Investigator II 192 (hrs)

2 Director of Operations 257 (hrs)

3 Epidemiologist 3,546 (hrs)

4 Principal Investigator 2,636 (hrs)

5 Project Coordinator 6,891 (hrs)

6 Project Manager 2,492 (hrs)

7 Program Manager 886 (hrs)

8 Research Analyst/Programmer III 4,597 (hrs)

9 Research Analyst/Programmer II (5 yrs) 5,466 (hrs)

10 Research Analyst/Programmer II (10 yrs) 8,887 (hrs)

11 Research Analyst/Programmer I 26,356 (hrs)

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Estimated Level of Effort

Fully Burdened Hourly Rate Total

12 Research Assistant 1,881 (hrs)

13 Medical Informaticist 1,154 (hrs)

Total Estimated Year Price $__________________

Ordering period #2: (exact dates to be completed upon award)

Estimated Level of Effort

Fully Burdened Hourly Rate Total

1 Co‐Investigator II 192 (hrs)

2 Director of Operations 257 (hrs)

3 Epidemiologist 3,546 (hrs)

4 Principal Investigator 2,636 (hrs)

5 Project Coordinator 6,891 (hrs)

6 Project Manager 2,492 (hrs)

7 Program Manager 886 (hrs)

8 Research Analyst/Programmer III 4,597 (hrs)

9 Research Analyst/Programmer II (5 yrs) 5,466 (hrs)

10 Research Analyst/Programmer II (10 yrs) 8,887 (hrs)

11 Research Analyst/Programmer I 26,356 (hrs)

12 Research Assistant 1,881 (hrs)

Ordering period #3: (exact dates to be completed upon award)

Estimated Level of Effort

Fully Burdened Hourly Rate Total

1 Co‐Investigator II 192 (hrs)

2 Director of Operations 257 (hrs)

3 Epidemiologist 3,546 (hrs)

4 Principal Investigator 2,636 (hrs)

5 Project Coordinator 6,891 (hrs)

6 Project Manager 2,492 (hrs)

7 Program Manager 886 (hrs)

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Estimated Level of Effort

Fully Burdened Hourly Rate Total

8 Research Analyst/Programmer III 4,597 (hrs)

9 Research Analyst/Programmer II (5 yrs) 5,466 (hrs)

10 Research Analyst/Programmer 11 (10 yrs) 8,887 (hrs)

11 Research Analyst/Programmer I 26,356 (hrs)

12 Research Assistant 1,881 (hrs)

Ordering period #4: (exact dates to be completed upon award)

Estimated Level of Effort

Fully Burdened Hourly Rate Total

1 Co‐Investigator II 192 (hrs)

2 Director of Operations 257 (hrs)

3 Epidemiologist 3,546 (hrs)

4 Principal Investigator 2,636 (hrs)

5 Project Coordinator 6,891 (hrs)

6 Project Manager 2,492 (hrs)

7 Program Manager 886 (hrs)

8 Research Analyst/Programmer III 4,597 (hrs)

9 Research Analyst/Programmer II (5 yrs) 5,466 (hrs)

10 Research Analyst/Programmer II (10 yrs) 8,887 (hrs)

11 Research Analyst/Programmer I 26,356 (hrs)

12 Research Assistant 1,881 (hrs)

Ordering period #5: (exact dates to be completed upon award)

Estimated Level of Effort

Fully Burdened Hourly Rate Total

1 Co‐Investigator II 192 (hrs)

2 Director of Operations 257 (hrs)

3 Epidemiologist 3,546 (hrs)

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Estimated Level of Effort

Fully Burdened Hourly Rate Total

4 Principal Investigator 2,636 (hrs)

5 Project Coordinator 6,891 (hrs)

6 Project Manager 2,492 (hrs)

7 Program Manager 886 (hrs)

8 Research Analyst/Programmer III 4,597 (hrs)

9 Research Analyst/Programmer II (5 yrs) 5,466 (hrs)

10 Research Analyst/Programmer II (10 yrs) 8,887 (hrs)

11 Research Analyst/Programmer I 26,356 (hrs)

12 Research Assistant 1,881 (hrs)

Grand Total: IDIQ Contract Price Evaluation Total

Total IDIQ Price Evaluation: Ordering Periods 1 through 5

**NOTE: This solicitation is being issued under the premise that the offeror will certify that the proposed positions listed above which are designated “exempt” are exempt from the Service Contract Act per Executive or Professional Employee under 29CFR 541.

B.2.6 Task Order 1: Data Sources for Surveillance of Biologics

LABOR CATEGORIES

Labor categories required to support the seed task order. If proposed labor categories are different, offerors should map their labor category titles to those in the pricing table.

No. Suggested Labor Category

Hours Proposed

Fully Burdened

Hourly Rate Total 1 CO- Investigator II

2 Director of Operations

3 Epidemiologist

4 Medical Informaticist

5 Principal Investigator

6 Project Coordinator

7 Project Manager

8 Program Manager

9 Research Analyst/Programmer III

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Hours Proposed

Fully Burdened

Hourly Rate Total 10 Research Analyst/Programmer II (5 yrs)

11 Research Analyst/Programmer II (10 yrs)

12 Research Analyst/Programmer I

13 Research Assistant

Other Direct Costs (identify each separately in price proposal see section E.2.1.4 c)

Total Estimated Task Order 1 Price $_________________________

B.2.7 Contract Payments The Contractor shall provide the necessary personnel, equipment, supplies and support services to perform as described in Section C of this document. In consideration for successful performance of these services, the Contractor shall be paid upon the presentation of a proper invoice in accordance with the applicable invoice clause with the Task Order contract type specified (i.e. Fixed Price, Time‐and‐Material and/or Labor Hour basis). Payment will be made monthly, in arrears, for services rendered to and accepted by the Government. Payment terms: Net 30 days after government acceptance of a proper invoice and acceptance of services. Advance payments will not be made.

B.2.8 Packing, Marking and Shipping

B.2.8.1 Preparation of Delivery All material to be delivered hereunder shall be afforded the degree of packing (preservation and packing) required to prevent deterioration and damages due to hazards of shipment, handling and storage. Best commercial practice will be accepted.

B.2.8.2 Prohibited Packaging Materials The use of asbestos, excelsior, newspaper, or shredded paper (all types including waxed paper, computer and similar hygroscopic or non‐neutral material) is prohibited. In addition, loose fill polystyrene is prohibited for shipboard use.

B.2.9 Inspection and Acceptance The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the Government’s COR specified at award. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the Contracting Officer.

B.2.10 Deliveries and/or Performance The Contracting Officer’s Representative (COR), a duly authorized representative of the CO, shall monitor the Contractor’s performance, evaluate the quality of services, and perform the final inspection and acceptance of all deliverables. Unless otherwise requested, deliverables shall be sent to the COR specified herein.

B.2.10.1 Reporting Requirements and Deliverables Deliverables required by this contract are outlined in the SOW.

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B.2.10.2 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, the contractor shall immediately provide written notification to the CO giving pertinent details. The data shall be informational in character and its receipt by the Government shall not be construed as a waiver by the contractor or any other rights or remedies provided to the Government by law or under this contract.

B.2.11 Place of Performance Most of the work should be performed at the contractor’s facility, to include maximizing technology to minimize travel elsewhere; however, note Paragraph GB.4.1 Travel Costs should travel be required.

B.2.12 Observance of Federal Holidays A. Government personnel observe the following days as holidays:

New Year’s Day Labor Day Martin Luther King’s Birthday Columbus Day President’s Day Veterans Day Memorial Day Thanksgiving Day Juneteenth Day Christmas Day Independence Day Inauguration Day for the DC metro Area.

B. Government Closures: When the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings, for other than firm‐fixed‐price contracts, the contractor will not be reimbursed when the government facility is closed for on‐site work at the Government site.

B.3 CONTRACT ADMINISTRATION DATA

B.3.1 Government Personnel Notwithstanding the Contractor’s responsibility for total management during the performance of this contract, administration of this contract shall require maximum coordination between the Government and the Contractor. The following individuals shall be the Government’s points of contact during performance of the contract:

B.3.1.1 Contracting Officer (CO) The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the contract;

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

The Contracting Officer for this contract is Regina Williams, regina.williams@fda.hhs.gov.

B.3.1.2 Contract Specialist (CS) All communications pertaining to the solicitation process, contractual, and administrative matters under the contract shall be addressed to the CS electronically only at the following address:

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Nick Sartain

FDA/OO/OFBA/OAGS/DAP/FOB

National Center for Toxicological Research 3900 NCTR Road, Building 50, 4th Floor Jefferson, AR 72079 Phone: (870) 543‐7370

B.3.1.3 Contracting Officer’s Representative (COR). The following COR will represent the Government for the purpose of this contract: (To be provided at contract award)

Name:

Email Address:

Phone:

Mailing Address:

(a) Performance of the work under this contract shall be subject to the technical direction of the COR identified above, or a representative designated in writing. The term "technical direction" includes, without limitation, direction to the contractor that directs or redirects the labor effort, shifts the work between work areas or locations, fills in details and otherwise services to ensure that tasks outlined in the work statement are accomplished satisfactorily.

(b) Technical direction must be within the scope of the specification(s)/work statement.

The COR does not have the authority to issue any technical direction that:

(1) Constitutes a change of assignment of additional work outside the specification(s) or SOW;

(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 the time required for contract performance;

(4) Changes any of the terms, conditions, or specification(s)/work statement of the contract;

(5) Interferes with the contractor’s right to perform under the terms and conditions of the contract;

or

(6) Directs, supervises or otherwise controls the actions of the contractor’s employees.

(c) Technical directions may be oral or in writing. The COR shall confirm oral direction in writing within five workdays, with a copy to the CO.

(d) The Contractor shall proceed promptly with the performance resulting from the technical directions issued by the COR. If, in the opinion of the contractor, any direction of the COR, or his/her designee, falls within the limitations in (b), above, the contractor shall immediately notify the CO no later than the beginning of the next Government workday.

(e) Failure of the contractor and the CO to agree that technical direction is within the scope of the contract shall be subject to the terms of the clause entitled "Disputes."

The type of actions within the purview of the COR’s authority is to assure that the Contractor performs the technical requirements of the contract, and to notify both the Contractor and the CO of any deficiencies observed. A letter of designation shall be issued to both the COR and the Contractor at the time of the contract award setting forth, in full, the responsibilities and limitations of the COR.

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B.3.2 HHSAR 352.237‐75 Key Personnel (DEC 2015) The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days’ notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

The Government reserves the right to evaluate the technical skill and competence of any Contractor staff members, to require removal and replacement, upon written notice, of any individuals whose qualifications or performance are judged deficient at any time.

The follow personnel are considered key personnel by the government:

To be identified at the task order level.

B.3.3 Contractor Performance Assessment Reports In accordance with FAR Subpart 42.15, FDA will complete annual (interim) and final contractor performance evaluations. Annual evaluations will be prepared to coincide with the anniversary date of the contract. Additional interim performance evaluations may be prepared at Contracting Officer discretion, as necessary. Final performance evaluations will be completed upon contract expiration.

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

Once a performance evaluation is issued, the Contractor’s primary and alternate CPARS contact will receive an email instructing them to logon to CPARS in order to review the performance evaluation. The Contractor has 14 days from the date of performance evaluation issuance in which to review the evaluation. If the Contractor is in agreement with the performance evaluation outcome, the evaluation becomes final. Should the Contractor be in disagreement with the performance evaluation outcome, rebuttal comments must be submitted via the CPARS within 14 days from date the evaluation was issued by the FDA. Any disagreement between the Contracting Officer and the Contractor will be referred to a contracting official one level above the Contracting Officer, whose decision will be final.

Copies of each performance evaluation and contractor responses, if any, will be retained as part of the official contract file and will be used to support future award decisions. Evaluations will also be stored for a 3‐year period in the https://www.cpars.gov/ system.

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

B.3.4 Ordering Procedures Ordering under this contract shall be accomplished by the issuance of written Task Orders. The only individual authorized to process Task Orders for the FDA is an Office of Acquisitions & Grants Services (OAGS) Contracting Officer.

All Task Orders issued hereunder are subject to the terms and conditions of this contract. This contract shall control in the event of conflict with any Task Order. The general process for individual Task Orders is as follows:

a) The FDA will prepare a Statement of Work (SOW). The SOW will include, at a minimum, the following elements:

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

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

3. Period and place of performance

4. Reporting requirements and deliverables

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

b) Requests for Task Order Proposals (RFTOPs) shall only be issued by the FDA OAGS Contracting Officer or Specialist.

c) The Contractor shall prepare and submit a Task Order (TO) proposal addressing all areas of the requirement. The Contractor shall submit the Task Order proposal within the time period specified in the RFTOP and adhere to the ceiling rates established in the contract. Other direct costs shall be clearly identified, explained, and substantiated. Travel Expenses (See B.4.1 below) ‐ Travel rates will be limited to those costs authorized by the Federal Travel Regulations in effect at the time of TO negotiations. Trips in excess of the approved number set forth in each TO will be at the Contractor’s expense. The contractor shall identify the estimated travel requirements by number, purpose and duration (inclusive of travel days in/out) with the submission of each proposed TO. No separate payment will be made to the contractor for the cost to prepare, submit and/or negotiate a Task Order proposal. The Government will evaluate Task Order proposals as specified in the individual RFTOP on a best value basis.

d) The FDA Contracting Officer placing the task order shall issue either an OF347, SF1449 or other designated form to the Contractor. Task orders performance period may extend beyond the five year ordering period provided the task order was issued prior to ordering period five expiration, up to and not longer than one (1) year and six (6) months.

B.4.1 Travel Costs and Other Direct Costs Travel and ODC costs/pricing shall be included in each of the offeror’s overall Task Order pricing, noting however, that (1) costs for travel within the area of Washington, D.C. (i.e., the District of Columbia;

Alexandria, Fairfax, and Falls Church Cities, Va.; Arlington, Fairfax, Loudon, and Prince Williams Counties, Va.; and Charles, Montgomery, and Prince Georges Counties, Md.) will not be allowed nor reimbursed, (2) travel costs shall be limited to that authorized by FAR 31.205‐46, (3) no fee/profit will be allowed/paid,

(4) all travel outside of the Washington, D.C area shall be authorized and requested in advance (minimum

75F40124R00002 Amendment 3 Page 15 of 67 of 30 calendar days) to the COR, and (5) the Contractor will be responsible for making all required travel arrangements for its personnel. Travel claims/invoices shall be include receipts required as attachments to the invoice to support travel claims:

1. Copy of common carrier ticket reflecting class of travel, dates of travel and amount of fare;

2. Lodging receipt;

3. Parking/tolls receipts;

4. Rental car receipt including receipts for gasoline;

5. Receipts for taxi travel.

B.4.2 Additional Labor Categories At any time and throughout the life of the contract, at the request of either the Contractor or the Government, the Contractor may propose additional labor categories, rates and descriptions in addition to the Government labor categories identified in Section B to support the tasks as identified in the SOW and/or RFTOP. These additional labor categories, rates and descriptions will be negotiated on a case‐by‐ case basis. The additional categories, rates and descriptions quoted, upon determination by the Government that they are necessary for performance and are both fair and reasonable, can be issued in the order. The new category may be incorporated by modification into the Section B Labor Rate Tables of this contract.

B.4.3 Tobacco Free Facilities In accordance with Department of Health and Human Services (HHS) policy, the Contractor and its staff are prohibited from using tobacco products of any kind (e.g., cigarettes, cigars, pipes, and smokeless tobacco) while on any HHS property, including use in personal or company vehicles operated by Contractor employees while on an HHS property. This policy also applies to all subcontracts awarded under the contract or order. The term ‘‘HHS properties’’ includes all properties owned, controlled and/or leased by HHS when totally occupied by HHS, including all indoor and outdoor areas of such properties.

Where HHS only partially occupies such properties, it includes all HHS‐occupied interior space. Where HHS leases space in a multi‐occupant building or complex, the tobacco‐free HHS policy will apply to the maximum area permitted by law and compliance with the provisions of any current lease agreements.

The Contractor shall ensure that each of its employees and any subcontractor staff is made aware of, understand, and comply with this policy.

B.4.4 Occupational Safety and Health Terms and Conditions

SECTION I – GENERAL OCCUPATIONAL SAFETY AND HEALTH TERMS AND CONDITIONS

1. The contractor is responsible for ensuring contractor personnel comply with applicable OSHA requirements, report unsafe conditions or activities to the Contracting Officer’s Representative (COR), and avoid actions and conditions that may result in an accident.

2. The contractor shall submit to the COR a site‐specific safety and accident prevention plan and OSHA 300A reports from the past three calendar years.

3. The contractor shall report all workplace incidents, accidents, injuries, and near‐misses that occur within the scope of the acquisition (whether OSHA‐recordable or not) to the COR by email as soon as possible, but no more than 24‐hours after discovery of the incident, illness or injury, or near‐miss.

4. The contractor shall provide an investigation report at no cost to the Government for all workplace incidents, accidents, injuries, and near‐misses that occur within the scope of the acquisition (whether OSHA‐recordable or not) to the COR by email as soon as possible, but no more than 24‐hours after the conclusion of the investigation of the incident, illness or injury, or near‐miss.

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5. The contractor shall report all activities or conditions that pose imminent danger or harm to persons, animals, or Government property immediately upon discovery to FDA Security or directly to local emergency services, as appropriate. In addition, the contractor shall report the incident to the COR immediately thereafter.

6. The contractor shall be responsible for any and all costs, expenses, and other obligations paid or incurred, due to the contractor’s noncompliance with federal, state, and/or local laws or ordinances.

7. As applicable, the contractor shall provide personal protective equipment (e.g., hard hats, safety glasses, work gloves) for anticipated hazards and ensure that contractor personnel wear the prescribed safety and health equipment within the work area, as prescribed by 29 CFR part 1910, Subpart I. The contractor shall provide instructions to personnel on the proper wear, maintenance, and limitations of the personal protective equipment prior to commencement of any work under the acquisition.

8. Prior to bringing any hazardous material to an FDA facility, the contractor shall provide the COR copies of any Safety Data Sheets (SDS) to obtain advance, written authorization.

8.1. Unless otherwise specified in the acquisition, the contractor is responsible for removing any hazardous material, or any material with an SDS, that the contractor brought with them for use at an FDA facility before or during performance of the acquisition.

B.4.5 Personnel Security Clearance Standards and Residency Requirements (October 2017)

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

Contractor employees who will work in DHHS‐owned or leased space for less than thirty (30) days are considered visitors and are exempted from background investigation requirements; and therefore, will not be issued a Personal Identity Verification (PIV) Card. These contractor employees go through visitor screening each day and must be escorted at all times while in DHHS‐owned or leased space.

2. GENERAL ‐ The Contractor must submit the following items to the Contracting Officer’s Representative (COR), within five (5) business days of commencement of work under this contract:

A roster of contractor employee names, identifying Key Personnel and Tier designation(s);

Confirmation all individual employee security information has been submitted properly; and

"Contractor's Commitment to Protect Non‐public Information Agreement" forms signed by each employee named in the roster.

Pursuant to HSPD‐12, the Contractor must advise its prospective employees about the security and background requirements stated herein.

For any individual who does not obtain a favorable background investigation he/she must cease work on the contract immediately.

If a Contractor employee changes job responsibilities under this contract, the Contractor must notify the COR, and the Government will make a determination whether an additional security clearance is required.

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In the event there are any proposed personnel changes in the Contractor’s staffing roster previously submitted to the COR, the Contractor must submit an updated roster to the COR, along with a brief explanation for the change. In turn, the COR will initiate the procedures stated herein to ensure any new contractor employees obtain a PIV card in a timely manner – prior to that individual commencing work under the contract.

Note: If the proposed personnel change is for a position designated Key Personnel under the contract, a complete justification – along with a resume or curriculum vitae – must be submitted to the Contracting Officer and COR for review and approval. If approved, the Contracting Officer will execute a Contract Modification prior to that individual commencing work under the contract.

3. BACKGROUND INVESTIGATIONS ‐ 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. Employees who hold or have previously held a Government security clearance must advise the FDA Personnel Security Staff of the details of such clearance.

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

4. CONTRACT RISK DESIGNATION(S) ‐ Contractor employees who will be in DHHS‐owned or leased space for thirty (30) days or more must be able to obtain and shall obtain a PIV card pursuant to Homeland Security Presidential Directive‐12 (HSPD‐12) in order to access to DHHS‐owned or leased property without an escort. (See Section 6 for details on the PIV Card process) However, in the event that work must commence before a security screening can be completed, contractor employees will be considered visitors, as described above, and 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 system (e‐QIP) system. The FDA Personnel Security Specialist will provide access to the e‐QIP as well as guidance as to which forms will be required. The forms required vary with the position risk designations for the contract.

All standard forms submitted to the FDA will be forwarded to the Office of Personnel Management (OPM) to initiate background investigations. The assigned FDA Personnel Security Specialist will resolve with the contractor employee any issues arising out of inaccurate or incomplete forms.

The Risk Designation(s) for this contract is/are Tier(s): ___2___

There are three (3) potential position risk designations, which are:

Non‐Sensitive Low Risk (Tier 1) ‐ Positions which involve the lowest degree of adverse impact on the efficiency of the Agency. The forms set forth by the FDA Personnel Security Specialist are required for Non‐Sensitive Low Risk Positions.

Sensitive Moderate Risk (Tier 2) or Sensitive High Risk (Tier 4) ‐ Public Trust Positions ‐ Positions in which the incumbent's actions or inaction could diminish public confidence in the integrity, 75F40124R00002 Amendment 3 Page 18 of 67 efficiency, or effectiveness of assigned Government activities, whether or not actual damage occurs.

In order to access the e‐QIP system, Contractor employees must provide the appropriate FDA 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. This information will be provided on the e‐QIP form that will be electronically sent to the employee. The FDA Personnel Security Specialist will use this information to enter 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 background investigation.

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.

Furthermore, any such noncompliance may detrimentally impact Contractor performance, Contractor performance evaluations, rights and remedies available at law and equity retained by the Government.

5. PERSONAL IDENTITY VERIFICATION (PIV) CARDS ‐ All PIV Cards (and any other type of Government‐ issued Access Card) shall remain the property of the Federal Government. At any time, if a Contractor employee is terminated or otherwise ceases work under the contract, or no longer requires a PIV Card for contract performance purposes, the Contractor must collect the individual’s PIV card and immediately notify FDA Personnel Security Staff in writing, with copies to the respective COR and Contracting Officer.

The Contractor must immediately return the PIV Card(s) to the COR.

Because PIV Cards, like other Government‐issued Access Cards are Government property, Contractors and Contractor Employees are hereby placed on notice that any abuse, destruction, defacement, unauthorized transfer or withholding (i.e., failure to return to the Government) may be punishable to the greatest extent at law.

Unauthorized possession of a PIV Card, or any other type of Government‐issued Access Card, and/or willfully allowing any other person to have or to use your Access Card, is prohibited and can be criminally prosecuted under 18 U.S.C. §§ 499 and 70I, which prohibit photographing or otherwise reproducing or possessing HHS identification cards in an unauthorized manner, under penalty of fine, imprisonment, or both. Wrongdoers may also be held financially responsible for any/all civil and equitable remedies – to include, but not limited to, damages for any pecuniary loss suffered by the Government as a result of any of the above‐listed actions or failure to act.

6. PIV CARD PROCESS ‐ The COR will sponsor Contractor employees on the Form HHS 745 and HHS Smart Card Management System (SCMS) for the purpose of obtaining an FDA PIV Card. In order to obtain a PIV card, a Contractor employee must receive a favorable FBI fingerprint return and complete required security forms. The FDA Personnel Security Specialist will provide the Contractor employee(s) direction for scheduling fingerprinting appointments at the FDA location or other approved location.

During a fingerprint appointment, each contractor employee must present two (2) forms of identification in order to receive his or her PIV Card. One form of identification must be a government‐issued photo identification document. Acceptable forms of identification are listed in Appendix A, provided below. An individual who receives an unfavorable report may appeal that finding by submitting a written request to the FDA Personnel Security Specialist.

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Required background investigations may include, but are not 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.

7. RESIDENCY REQUIREMENTS FOR FOREIGN NATIONALS ‐ Under the requirements for Homeland Security Presidential Directive‐12 (HSPD‐12), OPM can complete a background investigation only for persons who have resided in the U.S. for a total of at least three (3) of the past five (5). The residency requirements apply only to foreign nationals. If any prospective foreign national contractor/subcontractor employee does not meet the residency requirements, he/she cannot qualify for a PIV Card under HSPD‐12.

8. NON‐PUBLIC DATA PROTECTION ‐ The Contractor must protect the privacy of all information reported by or about Contractor employees and protect against unauthorized disclosure.

*Upon a favorable fingerprint return, the Contractor will be notified to return to the Badging and Credentialing Office for their building pass.

*Food and Drug Administration Badging and Credentialing Office 8:00 a.m. – 11:00 a.m. and 1:00 p.m. – 3:00 p.m., Eastern Time Office of Regulatory Compliance and Risk Management 3900 NCTR Road Bldg. 54, Room 128 Jefferson, AR 72079 Appointment required

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.

Furthermore, any such noncompliance may detrimentally impact Contractor performance, Contractor performance evaluations, rights and remedies available at law and equity retained by the Government.

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

b. Contractor employees who will work on the National Center for Toxicological Research facility shall contact the following to arrange for fingerprinting:

Food and Drug Administration National Center for Toxicological Research Office of Regulatory Compliance and Risk Management 3900 NCTR Road Bldg. 54, Room 128 Jefferson, AR 72079

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Appendix A:

B.4.6 Required Insurance

a. Worker's Compensation and Employer's Liability. Contractors are required to comply with applicable Federal and State workers' compensation and occupational disease statutes. If occupational diseases are not compensable under those statutes, they shall be covered under employer's liability section of the insurance policy, except when contract operations are so commingled with a Contractor's commercial operations that it would not be practical to require this coverage. Employer's liability coverage of at least $100,000 is required, except in States with exclusive or monopolistic funds that do not permit workers' compensation to be written by private carriers.

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b. General liability. Bodily injury liability insurance coverage written on the comprehensive form of policy of at least $500,000 per occurrence is required.

c. Automobile liability. The Contractor shall provide automobile liability insurance written on the comprehensive form of policy. The policy shall provide for bodily injury and property damage liability covering the operation of all automobiles used in connection with performing the contract. Policies covering automobiles operating in the United States, its possessions, and Puerto Rico shall provide coverage of at least $200,000 per person and $500,000 per occurrence for bodily injury and $20,000 per occurrence for property damage. The amount of liability coverage on other policies shall be commensurate with any legal requirements of the locality and sufficient to meet normal and customary claims.

B.4.7 Reporting Matters Involving Fraud, Waste, and Abuse Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in FDA‐ funded programs is encouraged to report such matters to the HHS Inspector General’s Office in writing or to the Inspector General’s Hotline. The toll‐free number is 1‐800‐HHS‐TIPS (1‐800‐447‐8477). All telephone calls will be handled confidentially. The email address is HHStips@oig.hhs.gov and the mailing address is:

Office of Inspector General Department of Health and Human Services Attn: HOTLINE P.O. Box 23489 Washington, D.C. 20026

B.4.8 Non‐Personal Services The Government and the Contractor understand and agree that the services delivered by the Contractor to the Government are non‐personal services.