BEST_IDIQ_1_RFP_FDA-18-223-SOL-1196209_amendment_4.pdf

(BEST) Initiative: Data, Tools and Infrastructure for Surveillance of Biologics Solicitation Number: FDA-18-223-SOL-1196209 Amendment 4

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

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: Data, Tools and Infrastructure for Surveillance of Biologics.

B.1. MINIMUM AND MAXIMUM CONTRACT AMOUNTS

The guaranteed minimum amount for this contract is $10,000.00. This minimum shall be met through the issuance of one or more task orders. The maximum contract amount, inclusive of the five (5) year ordering period under the contract, is estimated not to exceed $75,000,000.00.

B.2. CONTRACT TYPE: Multiple Award Indefinite Delivery / Indefinite Quantity (ID/IQ)

The Government intends to award a multiple-award Indefinite Delivery/Indefinite Quantity contract per FAR parts 12, 15, 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.3. CONSIDERATION AND PAYMENT

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).

The Contractor shall comply with FAR 52.232-7, Payments Under Time and Material and Labor-Hour Contracts or 52.232-25 Prompt Payment for fixed price task orders.

Upon presentation of a proper invoice, payment will be made no more frequently than monthly, in arrears, for services/supplies rendered to and accepted by the Government.

The Contractor shall not exceed the maximum, loaded hourly direct labor rates for each category listed below.

B.3.1. FIVE YEAR ORDERING PERIOD OF PERFORMANCE

ORDER PERIOD #1: (EXACT DATES TO BE COMPLETED UPON AWARD (see F-1 for estimated dates)

LABOR CATEGORIES

Labor categories below required to support the system over the duration of the contract including implementation and maintenance phases. 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.

No. Suggested Labor Category

Estimated Level of Effort

Fully Burdened

Hourly Rate Total

1 Principal Investigator 1,920 (hrs)

2 Co-Principal Investigator 1,920 (hrs)

3 Co-Investigator II 1,920 (hrs)

4 Co-Investigator I 1,920 (hrs)

5 Senior Statistician 3,840 (hrs)

6 Epidemiologist 5,760 (hrs)

7 Research Analyst/Programmer II 3,840 (hrs)

8 Research Analyst/Programmer I 3,840 (hrs)

9 Project Manager 1920 (hrs)

10 Research Assistant 5,760 (hrs)

11 Physician 3,840 (hrs)

12 Medical Informaticist 1,920 (hrs)

13 Medical Records Technician 1,920 (hrs)

Total Estimated Year Price

ORDER PERIOD #2: (EXACT DATES TO BE COMPLETED UPON AWARD)

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

of Effort

Fully Burdened

Hourly Rate Total

1 Principal Investigator 3,840 (hrs)

2 Co-Principal Investigator 3,840 (hrs)

3 Co-Investigator II 3,840 (hrs)

4 Co-Investigator I 7,680 (hrs)

5 Senior Statistician 7,680 (hrs)

6 Epidemiologist 7,680 (hrs)

7 Research Analyst/Programmer II 11,520 (hrs)

8 Research Analyst/Programmer I 11,520 (hrs)

9 Project Manager 7,680 (hrs)

10 Research Assistant 7,680 (hrs)

11 Physician 5,760 (hrs)

12 Medical Informaticist 3,,840 (hrs)

13 Medical Records Technician 3,840 (hrs)

Total Estimated Yearly Price

ORDER PERIOD #3: (EXACT DATES TO BE COMPLETED UPON AWARD)

Labor categories required to support the system over the duration of the contract including implementation and maintenance phases. If proposed labor categories are different, offerors should map of Effort

Fully Burdened

Hourly Rate Total

1 Principal Investigator 3,840 (hrs)

2 Co-Principal Investigator 3,840 (hrs)

3 Co-Investigator II 3,840 (hrs)

4 Co-Investigator I 7,680 (hrs)

5 Senior Statistician 7,680 (hrs)

6 Epidemiologist 7,680 (hrs)

7 Research Analyst/Programmer II 11,520 (hrs)

8 Research Analyst/Programmer I 11,520 (hrs)

9 Project Manager 7,680 (hrs)

10 Research Assistant 7,680 (hrs)

11 Physician 5,760 (hrs)

12 Medical Informaticist 3,840 (hrs)

ORDER PERIOD #4: (EXACT DATES TO BE COMPLETED UPON AWARD)

Labor categories required to support the system over the duration of the contract including implementation and maintenance phases. If proposed labor categories are different, offerors should map of Effort

Fully Burdened

Hourly Rate Total

1 Principal Investigator 3,840 (hrs) of Effort

Fully Burdened

Hourly Rate Total

2 Co-Principal Investigator 3,840 (hrs)

3 Co-Investigator II 3,840 (hrs)

4 Co-Investigator I 7,680 (hrs)

5 Senior Statistician 7,680 (hrs)

6 Epidemiologist 7,680 (hrs)

7 Research Analyst/Programmer II 11,520 (hrs)

8 Research Analyst/Programmer I 11,520 (hrs)

9 Project Manager 7,680 (hrs)

10 Research Assistant 7,680 (hrs)

11 Physician 5,760 (hrs)

12 Medical Informaticist 3,840 (hrs)

ORDER PERIOD #5: (EXACT DATES TO BE COMPLETED UPON AWARD)

Labor categories required to support the system over the duration of the contract including implementation and maintenance phases. If proposed labor categories are different, offerors should map of Effort

Fully Burdened

Hourly Rate Total

1 Principal Investigator 3,840 (hrs)

2 Co-Principal Investigator 3,840 (hrs) of Effort

Fully Burdened

Hourly Rate Total

3 Co-Investigator II 3,840 (hrs)

4 Co-Investigator I 7,680 (hrs)

5 Senior Statistician 7,680 (hrs)

6 Epidemiologist 7,680 (hrs)

7 Research Analyst/Programmer II 11,520 (hrs)

8 Research Analyst/Programmer I 11,520 (hrs)

9 Project Manager 7,680 (hrs)

10 Research Assistant 7,680 (hrs)

11 Physician 5,760 (hrs)

12 Medical Informaticist 3,840 (hrs)

Total Estimated Yearly Price $_____________

Grand total ordering periods 1 through 5

B.3.2. SEED TASK ORDER #0001:

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.

Hours Proposed

Fully Burdened

Hourly Rate Total

1 Principal Investigator

2 Co-Principal Investigator

3 Co-Investigator II

Hours Proposed

Fully Burdened

Hourly Rate Total

4 Co-Investigator I

5 Senior Statistician

6 Epidemiologist

7 Research Analyst/Programmer II

8 Research Analyst/Programmer I

9 Project Manager

10 Research Assistant

11 Physician

12 Medical Informaticist

13 Medical Records Technician

Total Estimated Labor, Seed Task Order #0001

This area is intentionally left blank.

SECTION C - DESCRIPTION/SPECIFICATION/WORK STATEMENT

The U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Biologics Effectiveness and Safety (BEST) Initiative: Data, Tools and Infrastructure for Surveillance of Biologics. The Contractor shall perform work in accordance with the terms, conditions and requirements set forth herein inclusive of attachments set forth in Section J.

SECTION D: PACKING AND MARKING

D.1. PACKAGING

All deliverables shall be packaged and packed in accordance with normal commercial practice to meet the packing requirements of the carrier, including that which is necessary to prevent deterioration and damage due to the hazards of shipping, handling and storing. The Contractor shall scan all electronic deliverables for viruses before submitting to the FDA

D.2. DELIVERY AND MARKING

All deliverables shall be marked as follows:

(a) Name and address of the Contractor;

(b) Contract Number

(c) Task Order Number

(d) Description of item contained therein; and

(e) Consignee’s name and address.

D.3. PAYMENT OF POSTAGE AND FEES

All postage and fees related to distribution of deliverable including forms, reports, etc., shall be paid by the Contractor.

SECTION E: INSPECTION AND ACCEPTANCE

E.1. INSPECTION AND ACCEPTANCE

The FDA COR will inspect and make acceptance decisions for all materials, documents, and services provided under this contract. The FDA COR is the authorized representative of the Contracting Officer. The COR shall monitor the Contractor’s performance, evaluate the quality of services and perform the final inspection and acceptance of all deliverables.

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

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): https://www.acquisition.gov/?q=browsefar

52.246-4 - Inspection of Services - Fixed-Price (AUG 1996) 52.246-6 - Inspection - Time-and-Material and Labor-Hour (MAY 2001) https://www.acquisition.gov/?q=browsefar

SECTION F - DELIVERIES OR PERFORMANCE

The Contractor shall provide the required reports referenced in the SOW Section J, Attachment A to the CO and COR.

Note: Actual deliverables, deliverable schedules, Progress Reports and Status meetings shall be established in the issuance of each individual task order. Additional Reporting Requirements may be included in each Task Order.

F.1. PERIOD OF PERFORMANCE

The period of performance for this IDIQ contract shall consist of a five 1- year ordering periods estimated to be:

Ordering period 1: September 3, 2018 through September 2, 2019 Ordering period 2: September 3, 2019 through September 2, 2020 Ordering period 3: September 3, 2020 through September 2, 2021 Ordering period 4: September 3, 2021 through September 2, 2022 Ordering period 5: September 3, 2022 through September 2, 2023

F.2. ORDERING 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.

F.3. OBSERVANCE OF FEDERAL HOLIDAYS

A. Government personnel observe the following days as holidays:

FEDERAL HOLIDAYS

New Year’s Day Martin Luther King’s Birthday President’s Day Memorial Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day

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 the above reasons.

F.4. 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 G.8 Travel Costs should travel be required.

F.5. AAM 2018.06-005 Macro Functionality Disabled

Be advised that FDA does not accept documents which contain the use of macros.

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.

F.6. FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): https://www.acquisition.gov/?q=browsefar

52.242-15 Stop-Work Order (AUG 1989) https://www.acquisition.gov/?q=browsefar

SECTION G - CONTRACT ADMINISTRATION DATA

G.1. 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.

TASK ORDER PROCESSING

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. 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 (RTOPs) shall only be issued by the Contracting Officer.

c) The Contractor shall prepare and submit a task order 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 G.8 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 RTOP on a best value basis.

G.2. CONTRACTING OFFICERS REPRESENTATIVE (COR)

The following COR will represent the Government for the purpose of this contract: (To Be Identified Upon Contract Award)

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

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. All questions regarding changes to the scope of work shall be directed to the Contracting Officer or Contracting Specialist. The term "technical direction" includes, without limitation, direction to the contractor that directs or redirects the labor effort and shifts the work between work areas or locations 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) /

PWS;

(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 work days, 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 work day.

(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.

G.3. 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 a task order; (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 contact information for the Contracting Officer is:

Jerry Martin

NCTR-50 RM434

3900 NCTR Road Jefferson, AR 72079 Email: Jerry.Martin@fda.hhs.gov Tel: 870-543-7040

The contact information for the Contract Specialist is:

Nick Sartain

NCTR-50 RM422

3900 NCTR Road Jefferson, AR 72079 Email: Nick.Sartain@fda.hhs.gov Tel: 870-543-7370

G.4. INVOICE SUBMISSION

A. The contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

Attn: Vendor Payments Office of Financial Services 10903 New Hampshire Ave WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002 301-827-3742 FDAVendorPaymentsTeam@fda.hhs.gov *** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail.

B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer - System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

mailto:Jerry.Martin@fda.hhs.gov mailto:Nick.Sartain@fda.hhs.gov

(i) Name and address of the contractor;

(ii) Invoice date and invoice number;

(iii) Contract/Order number (including a reference to any base award for Indefinite- Delivery/Indefinite-Quantity Contracts or Blanket Purchase Agreements);

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

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

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

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

(d) the contractor shall include the Contract Line Item/Funding line item for each description, quantity, unit of measure, unit 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 shipped on government bill of lading;

(vi) Terms of any discount for prompt payment offered (Prompt Payment terms other than NET 30); (vii) Name and address of contractor official to whom payment is to be sent (must be the same as that in the contract or in a proper notice of assignment);

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

(ix) Taxpayer Identification Number (TIN);

(x) Electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment;

(xi) Name and telephone number of the FDA Approving Official (i.e., Contracting Officer (CO) or Contract Specialist (CS), as referenced in the award document);

(xii) Name and telephone number of the FDA Contracting Officer Representative (COR) or other program center/office point of contact, as referenced in the award document;

(xiii) 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:

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

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order

(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance;

(xiv) Any other information or documentation required by the contract/order award.

C. An electronic invoice is acceptable if submitted in Adobe Acrobat (PDF) format. All items listed in (i) through (xii) of this clause must be included in the electronic invoice.

Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D. Questions regarding invoice payments should be directed to the FDA Payment Office at the e-mail address or phone number provided above in Section A.

G.5. 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:

Principle Investigator Project Manager Physician Epidemiologist

The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the contracting officer. The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate shall be available between, 9:00 a.m. to 5:30 p.m. Eastern Time, Monday thru Friday except Federal holidays.

G.6. 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. 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, will be incorporated by modification into the Section B Labor Rate Tables of this contract.

G.7. CONTRACTOR PERFORMANCE ASSESSMENT REPORT

In accordance with Federal Acquisition Regulation (FAR) 42.15, FDA will complete annual 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 30 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 30 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 Past Performance Information Retrieval System (PPIRS) at https://www.ppirs.gov/.

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

CPARS.

G.8. 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, Loudoun, and Prince William Counties, Va.; and Charles, Montgomery, and http://www.cpars.csd.disa.mil/cparsmain.htm https://www.ppirs.gov/ http://www.cpars.gov/allapps/cpcbtdlf.htm

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, overhead, or G&A will be allowed/paid, (4) all travel outside of the Washington, D.C. area shall be requested of and authorized in advance (minimum of 30 calendar days) by the COR, and (5) the Contractor will be responsible for making all required travel arrangements for its personnel.

G.9. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

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

Office of Inspector General Department of Health and Human Services Attn: HOTLINE 330 Independence Avenue, S.W.

Washington, D.C. 20201

G.10. PROPERTY, EQUIPMENT, SUPPLIES, FACILITIES, PERSONNEL AND

SERVICES

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.

mailto:HHStips@oig.hhs.gov

SECTION H - SPECIAL CONTRACT REQUIREMENTS

H.1. AUTHORITY TO OBLIGATE THE GOVERNMENT

The Contracting Officer is the only individual who can legally commit or obligate the Government to the expenditure of public funds. No cost chargeable to the proposed contract can be incurred before receipt of a fully executed contract, task order and/or modification or specific authorization from the Contracting Officer.

H.2. CONFLICT OF INTEREST AND CONFIDENTIALITY

(a) Purpose. The purpose of this clause is to ensure that the contractor and its subcontractors:

(1) Are not biased because of their financial, contractual, organizational, or other interests which relate to the work under this BPA, and

(2) Do not obtain any unfair competitive advantage over other parties by virtue of their performance of this BPA.

(b) Scope. This clause applies to performance or participation by the contractor, its parents, affiliates, divisions and subsidiaries, and successors in interest (hereinafter collectively referred to as “contractor”) in the performance of this BPA as a prime contractor, subcontractor, co-sponsor, joint venture, consultant, or in any similar capacity.

(c) Warrant and Disclosure. The warrant and disclosure requirements apply to both the contractor and all subcontractors. The contractor warrants that, to the best of the contractor's knowledge and belief, there are no relevant facts or circumstances which would give rise to an organizational conflict of interest, as defined in FAR Subpart 9.5, and that the contractor has disclosed all relevant information regarding any actual or potential conflicts. The contractor agrees it shall make an immediate and full disclosure, in writing, to the Contracting Officer of any potential or actual organizational conflict of interest or the existence of any facts that may cause a reasonably prudent person to question the contractor's impartiality because of the appearance or existence of bias or an unfair competitive advantage. Such disclosure shall include a description of the actions the contractor has taken or proposes to take in order to avoid, neutralize, or mitigate any resulting conflict of interest.

(d) Remedies. The Contracting Officer may terminate this award for convenience, in whole or in part, if the Contracting Officer deems such termination necessary to avoid, neutralize or mitigate an actual or apparent organizational conflict of interest. If the contractor fails to disclose facts pertaining to the existence of a potential or actual organizational conflict of interest or misrepresents relevant information to the

Contracting Officer, the Government may terminate the award for default or cause;

suspend or debar the contractor from Government contracting; or, pursue such other remedies as may be permitted at law or equity.

(e) Subcontracts. The contractor shall include a clause substantially similar to this clause, including paragraphs (f) and (g), in any subcontract or consultant agreement.

(f) Prime Contractor Responsibilities. The Contractor shall determine in writing whether the interests disclosed present an actual, or significant potential for, an organizational conflict of interest. The contractor shall identify and avoid, neutralize, or mitigate any subcontractor organizational conflict prior to award of the BPA or Order to the satisfaction of the Contracting Officer. If the subcontractor's organizational conflict cannot be avoided, neutralized, or mitigated, the contractor must obtain the written approval of the Contracting Officer prior to entering into the subcontract. If the contractor becomes aware of a subcontractor's potential or actual organizational conflict of interest after BPA or Order award, the contractor agrees that the Contractor may be required to eliminate the subcontractor from its team, at the contractor's own risk. The contractor shall obtain from its subcontractors or consultants any disclosures identifying any potential organizational conflicts of interest.

(g) Waiver. The contractor may seek a waiver from the Head of the Contracting Activity by submitting such waiver request to the Contracting Officer, including a full written description of the requested waiver and the reasons in support thereof.

(h) All contractor personnel involved in this requirement shall abide by the FDA Commitment to Protect Non-Public Information Agreement.

H.3. NON-PERSONAL SERVICES AND INHERENETLY GOVERNMENTAL

FUNCTIONS

Pursuant to FAR 37.1, no personal services shall be performed under this contract.

Work requirements shall flow only from the Contracting Officer or the COR to the Contractor's Project Manager. No Contractor employee will be directly supervised by the Government. All employee assignments, and daily work direction, shall be given by the applicable Contractor supervisor. If the Contractor believes any Government action or communication has been given that would create a personal services relationship between the Government and any Contractor employee, the Contractor shall promptly notify the Contracting Officer of this communication or action.

Pursuant to FAR 7.5, the Contractor shall not perform any inherently governmental actions under this contract. No Contractor employee shall hold him or herself out to be a Government employee, agent, or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government. In all communications with third parties in connection with this contract, Contractor employees shall identify themselves as Contractor employees and specify the name of the company for which they work. In all communications with other Government Contractors in connection with this contract, the Contractor employee shall state that they have no authority to in any way change this contract and that if the other Contractor believes this communication to be a direction to change their contract, they shall notify the Contracting Officer for that contract and not carry out the direction until a clarification has been issued by the Contracting Officer.

The Contractor shall insure that all of its employees working on this contract are informed of the substance of this article. Nothing in this article shall limit the Government’s rights in any way under the other provisions of this contract, including those related to the Government’s right to inspect and accept the services to be performed under this contract. The substance of this article shall be included in all subcontracts at any tier.

H.4. FDA 1350 ACCESS TO NON-PUBLIC INFORMAITON:

All Contractor and subcontractor employees are required to sign the Contractor's Commitment to Protect Non-Public Information (NPI) Agreement (Form FDA 3398) provided as Attachment D to this contract (See Section J). If a person who has signed this agreement resigns, is dismissed, or is otherwise no longer working on this contract, the Contractor shall notify the FDA COR and the Contracting Officer. Any new Contractor or subcontractor employee assigned to this contract shall sign the form, and the Contractor shall email it to the Contracting Officer and COR ten (10) days prior to said new employee's commencement of work on this contract.

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

Briefings

An FDA representative (typically, the Contracting Officer’s Representative) will conduct an orientation briefing for the Contractor at the Contract and Task Order Levels. The briefing will stress: (1) the importance of protecting non-public information; (2) specified computer/IT requirements as outlined in the DHHS Automated Information Systems Security Program Handbook; and (3) the consequences of unauthorized disclosure of non-public information. Briefing updates will be conducted annually.

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

H.5. 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.

H.6. DESIGNATION OF TASK ORDER / DELIVERY ORDER OMBUDSMAN

In accordance with FAR 16.505(b)(5) and HHSAR 316.505(b)(5), the Director, Office of Acquisitions and Grants Services, has been designated as the FDA Ombudsman for task order and delivery order contracts.

Leonard Grant 5630 Fisher’s Lane, Room 2100 Rockville, MD 20857 Phone: 240-402-7584 Fax: 301-827-7106 Email: Leonard.Grant@fda.hhs.gov

(End of Clause)

H.7 GOVERNMENT USE OF DATA

The Government will acquire the right to use, duplicate, or disclose in any manner and for any purpose whatsoever, and have or permit others to do so, all subject data required to be delivered under this contract.

Contractor disclosure: Any disclosure/publication by the Contractor/subcontractor(s) of data provided under this contract shall require prior FDA review and clearance.

mailto:Leonard.Grant@fda.hhs.gov

SECTION I: SOLICITATION PROVISIONS AND CONTRACT CLAUSES

I.1. FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE. (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address(es): https://www.acquisition.gov/?q=browsefar HHS Acquisition Regulation (HHSAR): https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html.

FAR

CLAUSE

NO.

TITLE AND DATE

52.202-1 Definitions (NOV 2013) 52.203-3 Gratuities (APR 1984) 52.203-5 Covenant Against Contingent Fees

(MAY 2014)

52.203-6 Restrictions on Subcontractor Sales to the Government (SEPT 2006) 52.203-7 Anti-Kickback Procedures (MAY 2014) 52.203-8 Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity

(MAY 2014)

52.203-10 Price or Fee Adjustment for Illegal or Improper Activity (MAY 2014)

52.203-12 Limitation on Payments to Influence Certain Federal Transactions (OCT 2010)

52.203-13 Contractor Code of Business Ethics and Conduct (OCT 2015)

52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017)

52.204-4 Printed or Copied Double-Sided on Recycled Paper (MAY 2011)

52.204-9 Personal Identity Verification of Contractor Personnel (Jan 2011)

52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards (OCT 2016)

52.204-15 Service Contract Reporting Requirements for Indefinite-Delivery Contracts. (OCT 2016)

52.204-16 Commercial and Government Entity Code Reporting. (JUL 2016)

52.204-18 Commercial and Government Entity Code Maintenance. (Jul 2016)

52.204-19 Incorporation by Reference of Representations and Certifications. (Dec 2014) https://www.acquisition.gov/?q=browsefar https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

52.204-23 Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (JUL 2018)

52.209-6 Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (OCT 2015)

52.209-9 Updates of Publicly Available Information Regarding Responsibility Matters.

(JUL 2013)

52.209-10 Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015)

52.215-2 Audit and Records – Negotiation (OCT 2010) 52.215-8 Order of Precedence – Uniform Contract Format (OCT 1997)

52.215-10 Price Reduction for Defective Cost or Pricing Data (AUG 2011) 52.215-11 Price Reduction for Defective Cost or Pricing Data – Modifications (AUG 2011) 52.215-12 Subcontractor Cost or Pricing Data (OCT 2010)

52.215-13 Subcontractor Certified Cost or Pricing Data Modifications (OCT 2010) 52.215-15 Pension Adjustments and Asset Reversions (OCT 2010) 52.215-19 Notification of Ownership Changes. (OCT 1997) 52.215-21 Requirements for Cost or Pricing Data or Information Other Than Cost or Pricing Da-ta – Modifications (OCT 2010)

52.216-18 Ordering. (OCT 1995)

(a) “ … from effective date of contract award through and including the last date of the contract including any extensions thereto.”

52.216-19 Order Limitations (OCT 1995)

(a) “…$10,000.00 per Task Order, …”

(b) (1) “… in excess of $25,000,000.00;”

(b) (2) “… in excess of $50,000,000.00;”

(b) (3) “… within five (5) calendar days…”

(d) “… within five (5) calendar days…” 52.216-22 Indefinite Quantity (OCT 1995)

(d) “…after three (3) years from date of contract expiration.”

52.216-31 Time-and-Materials/Labor-Hour Proposal Requirements-Commercial Item Acqui-sition (FEB 2007)

52.219-4 Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2014)

52.219-8 Utilization of Small Business Concerns (NOV 2016)

52.219-9 Small Business Subcontracting Plan (JAN 2017)

52.219-16 Liquidated Damages - Subcontracting Plan (JAN 1999)

52.219-28 Post Award Small Business Program Representation (Jul 2013) 52.222-3 Convict Labor (JUN 2003) 52.222-17 Nondisplacement of Qualified Workers (MAY 2014) 52.222-21 Prohibition of Segregated Facilities (APR 2015) 52.222-26 Equal Opportunity (SEP 2016)

52.222-35 Equal Opportunity Veterans (OCT 2015)

52.222-36 Affirmative Action for Workers with Disabilities (JUL 2014) 52.222-37 Employment Reports on Veterans (FEB 2016)

52.222-40 Notification of Employee Rights Under the National Labor Relations Act (DEC 2010)

52.222-41 Service Contract Labor Standards (MAY 2014)

52.222-42 Statement of Equivalent Rates for Federal Hires (May 2014) This statement is for information only: It is not a Wage Determination

Employee Class Monetary Wage-Fringe Benefits None (N/A) N/A

52.222-

Fair Labor Standards Act and Service Contract Act—Price Adjustment (MAY 2014)

52.222-49 Service Contract Labor Standards—Place of Performance Unknown (May 2014) “none”…“within ten (10) calendar days of solicitation issuance and subsequent post-award requests for task order proposals.”

52.222-50 Combating Trafficking in Persons (MAR 2015)

52.222-54 Employment Eligibility Verification (OCT 2015)

52.222-55 Minimum Wages Under Executive Order 13658 (DEC 2015)

52.222-62 Paid Sick Leave Under Executive Order 13706 (JAN 2017)

52.223-5 Pollution Prevention and Right-to-Know Information (MAY 2011)

52.223-6 Drug-Free Workplace (MAY 2001) 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving

(AUG 2011)

52.225-5 Trade Agreements (Oct 2016)

52.225-13 Restrictions on Certain Foreign Purchases (JUN 2008)

52.225-25 Prohibition on Contracting with Entities Engaging in Sanctioned Activities Relating to Iran— Representation and Certification (OCT 2015)

52.227-1 Authorization and Consent (DEC 2007)

52.227-2 Notice and Assistance Regarding Patent and Copyright Infringement (DEC 2007)

52.227-11 Patent Rights – Ownership by the Contractor (MAY 2014)

52.227-14 Rights in Data - General (MAY 2014)

52.227-17 Rights in Data - Special Works (DEC 2007) 52.232-7 Payments under Time-and-Materials and Labor-Hour Contracts (AUG 2012) 52.232-9 Limitation on Withholding of Payments (APR 1984)

52.232-17 Interest (MAY 2014)

52.232-18 Availability of Funds (APR 1984)

52.232-23 Assignment of Claims (MAY 2014) 52.232-25 Prompt Payment (JAN 2017) 52.232-33 Payment by Electronic Funds Transfer – System for Award Management

52.232-39 Unenforceability of Unauthorized Obligations (JUL 2013) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (JUL 2013) 52.233-1 Disputes (MAY 2014) Alternate I (Dec 1991).

52.233-3 Protest after Award. (AUG 1996) 52.233-4 Applicable Law for Breach of Contract Claim. (OCT 2004) 52.237-2 Protection of Government Buildings, Equipment, and Vegetation (APR 1984) 52.237-3 Continuity of Services (JAN 1991)

52.242-13 Bankruptcy (JUL 1995)

52.243-3 Changes – Time-and-Materials or Labor-Hours (SEPT 2000) 52.244-2 Subcontracts (OCT 2010) 52.244-5 Competition in Subcontracting (DEC 1996) 52.244-6 Subcontracts for Commercial Items (JUL 2018)

52.246-25 Limitation of Liability – Services (FEB 1997) 52.248-1 Value Engineering (OCT 2010)

52.249-2 Termination for Convenience of the Government (Fixed-Price) (APR 2012)

52.249-6 Termination (Cost-Reimbursement) (May 2004) Alternate IV (Sept 1996).

52.249-8 Default (Fixed-Price Supply and Service) (APR 1984) 52.249-14 Excusable Delays (APR 1984)

52.253-1 Computer Generated Forms (JAN 1991)

I .2. FAR 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days prior to contract or task order expiration.

This clause is applicable to the master IDIQ contract and task orders.

I.3. FAR 52.217-9 Option to Extend Term Services (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Con-tractor within 60 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed (5) years.

This clause may be included in and applicable to task orders

I.4. FAR Deviation

Department of Health and Human Service (HHS) Federal Acquisition Regulation (FAR) Class Deviation 18-01 Whistleblower Protection for Contractor Employees

Background: The FAR currently provides that when the 4-year pilot program under 41 U.S.C.

4712 expires, the previous whistleblower coverage is back in effect. However, the Civilian Agency Acquisition Council (CAAC) issued CAAC Letter 2017-02, dated July 5, 2017, to further implement 41 U.S.C. 4712 (as amended by Public Law 114-261) to make permanent the 4-year pilot program and clarifies the use of certain Whistleblower Protection clauses. In turn, the HHS Deputy Assistant Secretary for Office of Grants and Acquisition Policy and Accountability/Senior Procurement Executive issued HHS FAR Class Deviation 18-01, dated February 8, 2018, to im-plement CAAC guidance and Enhance Whistleblower Protection for Contractor Employees.

Pursuant to the above-stated authorities, the underlying solicitation/contract hereby in-corporates the following Terms and Conditions:

PART 3-IMPROPER BUSINESS PRACTICES AND PERSONAL CONFLICTS OF INTEREST

Subpart 3.9-whistleblower Protections for Contractor Employees

3.900 Scope of subpart.

This subpart implements various statutory whistleblower programs. This subpart does not im-plement 10 U.S.C. 2409, which is applicable only to DoD, NASA, and the Coast Guard.

41 U.S.C. 4705 (in effect before July 1, 2013). Sections 3.901 through 3 .906 of this subpart im-plemented 41 U.S.C. 4705, applicable to civilian agencies other than NASA and the Coast Guard.

41 U.S.C. 4712 (in effect on and after July 1, 2013). Section 3.908 of this subpart implements the pilot program, applicable to civilian agencies other than NASA and the Coast Guard, except as provided in paragraph {d) of this section.

Section 743 of Division E, Title VII of the Consolidated and further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions), implemented in 3.909, applicable to all agencies.

Contracts funded by the American Recovery and Reinvestment Act. Section 3.907 of this subpart implements section 1553 of the American Recovery and Reinvestment Act of 2009 (Pub. L.