RFP 75F40123R00068.pdf

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CODE 18a. PAYMENT WILL BE MADE BY

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17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

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10. THIS ACQUISITION ISCODE

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14. METHOD OF SOLICITATION

13b. RATING

NAICS:

SMALL BUSINESS

05/10/2023

NATAPOL SIRIKHAN

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INFORMATION CALL:

FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIME

05/26/2023 1200 ET

b. TELEPHONE NUMBERa. NAME

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

75F40123R00068

5. SOLICITATION NUMBER

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 1. REQUISITION NUMBER PAGE OF

1 21265163OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

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17a. CONTRACTOR/

Silver Spring MD 20993-0002 Bldg 32, Rm 2162, Mail Hub 2145 10903 New Hampshire Avenue US Food and Drug Administration FDA - 10903 New Hampshire Avenue

15. DELIVER TO

Beltsville MD 20705 4041 Powder Mill Road ATTN: Natapol Sirikhan

9. ISSUED BY

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2. CONTRACT NO.

EFFECTIVE DATE

$32.5

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW

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DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

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SEE SCHEDULE

12. DISCOUNT TERMS

THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

8(A)

DHHS/FDA/OAGS/DAO

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

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SCHEDULE OF SUPPLIES/SERVICES

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ITEM NO.

See Attached SOW (Page 1-24) Delivery: 05/TBD/23 - 05/TBD/24

(Use Reverse and/or Attach Additional Sheets as Necessary)

HEREIN, IS ACCEPTED AS TO ITEMS:

XX

DATED . YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

ARE

ARE

31c. DATE SIGNED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print)

ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL

SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

26. TOTAL AWARD AMOUNT (For Govt. Use Only)

OFFER

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA - FAR (48 CFR) 53.212

ARE NOT ATTACHED.

ARE NOT ATTACHED.

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

30b. NAME AND TITLE OF SIGNER (Type or print)

30a. SIGNATURE OF OFFEROR/CONTRACTOR

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

25. ACCOUNTING AND APPROPRIATION DATA

29. AWARD OF CONTRACT:

REF.

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

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CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

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75F40123R00068

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

FOOD AND DRUG ADMINISTRATION

The Office of Facilities Engineering and Mission Support Services (OFEMS) Division of Operations Management and Community Relations (DOMCR)

Logistics and Transportation Management Branch (LTMB)

Transit Analysis for Shuttle Schedule Optimization

Date: March 20, 2023 Version Number: 0.1

Table of Contents

1. BACKGROUND

2. APPLICABLE DOCUMENT

3. SCOPE

4. PERFORMANCE DETAILS

4.1. Contract Type

4.2. Period of Performance

4.3. Place of Performance

5. DESCRIPTION OF WORK

5.1. Logistics and Route Planning

5.2. Transit…………………………………………………………………………………………...5

5.3. Implementation and Approach……………………………………………………………..5

6. SECURITY REQUIREMENTS

7. GOVERNMENT FURNISHED INFORMATION…………………………………………..6

8. DELIVERABLES

9. CONTRACT ADMINISTRATION

10. CLAUSES……………………………………………………………………………………..…13

11. REPRESENTATIONS AND INSTRUCTIONS………………………………………………….17

12. PROPOSAL INSTRUCTIONS……………………………………………………………...21

13. PROPOSAL SUBMISSION…………………………………………………………………22

14. BASIS FOR AWARD………………………………………………………………………..23

STATEMENT OF WORK

1. BACKGROUND

The Office of Facilities Engineering and Mission Support Services (OFEMS), Division of Operations Management and Community Relations (DOMCR), Logistics and Transportation Management Branch (LTMB) provides transportation, transit and parking related service for the Food and Drug Administration (FDA). These services are provided for the White Oak Campus located at 10903 New Hampshire Ave, Silver Spring, Maryland 20993. The White Oak Campus is a worksite for approximately 11,000 FDA and contract employees. The National Capital Planning Commission (NCPC) approved master plan that applied at the time of development of the campus limited the number of parking spaces that can be provided on campus to a ratio of 1 space for every 1.5 employees.

2. APPLICABLE DOCUMENT

The Contractor shall comply with the following applicable documents:

• 31 U.S. Code § 1344, “Passenger Carrier Use” (https://www.law.cornell.edu/uscode/text/31/1344)

• USC Title 49, Subtitle A, Part 38, “Americans With Disabilities Act (ADA) Accessibility Specifications for Transportation Vehicles.”

(https://www.law.cornell.edu/cfr/text/49/part-38)

3. SCOPE

In order to provide transportation, transit, and parking related services for the FDA employees on campus, the many visitors that conduct business with the Agency, and the general public received by the Agency, DOMCR/LTMB requires the service of a contractor capable of providing a transit analysis associated with the operation of a large Campus transportation program. The Contractor shall provide planning and consultation services related to transportation, transit and parking implementing operations related to these program areas.

Independently, and not as an agent of the Government, the Contractor shall furnish the necessary personnel, materials, services, facilities, and otherwise do all things necessary for or incident to the performance of the work as described below:

a. To conduct an analysis of all relevant transit options within the FDA White Oak Campus service area

b. To update and modify FDA Commuter and Circulator Shuttle Bus schedules servicing the White Oak Campus in Silver Spring, Maryland based on the results of the analysis with the objective of supplementing the services provided by local public transit agencies, and to provide for service where there are gaps in service provided by public transit agencies.

4. PERFORMANCE DETAILS

4.1. Contract Type

This Contract shall be issued on a Firm Fixed Price (FFP) basis.

https://www.law.cornell.edu/uscode/text/31/1344 https://www.law.cornell.edu/cfr/text/49/part-38

4.2. Period of Performance

This Contract will have an anticipated base period of performance of twelve (12) months.

4.3. Place of Performance

The Contractor shall primarily perform activities at the contractor’s office location.

5. DESCRIPTION OF WORK

5.1. Logistics and Route Planning

The Contractor shall provide the planning and scheduling expertise needed to analyze and propose modifications to service locations and schedule to optimize the efficiency of the shuttle service creating critical connections for FDA commuters to the greater transit system providing on time service to various transit centers and the FDA White Oak Campus, and to provide convenient on site mobility to FDA personnel and visitors. Schedules shall consider commuting origins and destinations, routine tour of duties of FDA personnel over an 8.5-hour workday, public transit schedules that serve the site directly and service during evening hours for employees who may work late. Route schedules should avoid the duplication of services, existing and planned, provided by local transit agencies. All route schedules must be integrated into the service schedules for existing shuttle service at the White Oak site and existing and planned public transit service to the White Oak site. The existing service schedules for existing shuttle services will be provided to the Contractor after task order award.

The Contractor shall conduct an analysis of all relevant transportation options within the FDA White Oak Campus service area. This analysis shall include data associated with the transportation options for FDA stakeholders to various transit centers and the White Oak Campus and other relevant destinations. The analysis shall include the following sections:

5.1.1 Background

a. Transportation and Transit Planning History: The Contractor shall include a summary of all activities associated with the prior Transportation Planning support.

b. Current Transit Service Area (as of time of analysis): The Contractor shall provide a map and subsequent narrative description of the current transportation service area. This service area shall be used as a baseline for the new analysis.

c. Results of Previous Analyses: The Contractor shall incorporate a high-level summary of any previous analyses associated with the service provisioning at the White Oak Campus and relevant analysis developed as a result of the campus development or in provisioning public transit service in the local area.

5.2 Transit

5.2.1 Section 1

The Contractor shall comprehensively analyze the FDA Shuttle Program including all existing routes.

a. Transit Standards: The Contractor shall include a description of the transit standards associated with service provisioning at the White Oak Campus, including the frequency of service and rate of on time service.

b. Existing Transit Routes: The Contractor shall describe the existing transit routes (including maps and ridership data) related to service provisioning at the White Oak Campus.

c. Emerging Transit Services: The Contractor shall provide a description of the emerging transportation services that may have impacts on the service provisioning at the White Oak Campus. These may include, but not be limited to, the following:

i. Ride On Service Modifications

ii. WMATA Purple Line Expansion

iii. Ride Sharing Options (Uber, Lyft, etc.)

iv. Montgomery County Department of Transportation Initiatives (i.e.

Bus Rapid Transit (BRT) implementation)

d. Transportation Demand Management: The Contractor shall include a description of the overall objectives to achieve transportation demand management.

e. Transportation Analysis: The Contractor shall leverage the information ascertained in this section to conduct an analysis to focus on the following:

i. Estimated Travel Time adjusted for traffic conditions

ii. Transit Services

iii. Impact

iv. Findings

f. Recommendations: The Contractor shall provide recommendations based on the results of its analysis including, but not limited to:

i. Recommended modifications to schedule utilizing only resources currently provided under Section 1

ii. Recommended modifications for maximizing efficiency of services through the addition of resources (vehicles and/or personnel).

5.3 Implementation Approach

5.3.1 Section 1

The Contractor shall comprehensively analyze the FDA Shuttle Program to include all existing routes.

a. Service Offering Map Amendments: The Contractor shall provide an updated service offering map to include a description of all amendments to the baseline service maps.

b. Design Guidelines: The Contractor shall elaborate on the methodology used to inform the incorporation of the analysis results and subsequent route design elements.

c. Communications Approach: The Contractor shall describe in a plan its approach to communicate the changes to the schedules and routes based on the amended service offering. The plan shall also address timeframes for advertising the changes.

d. Other Relevant Information: The Contractor shall include any additional information that is relevant to the changes associated with the revised shuttle service routes and schedules.

e. Schedule: The Contractor shall provide the finalized schedule based on the completion date of the analysis.

Deliverable:

Section 1 A. Summary of Present and Future Transit Conditions B. Transit Analysis C. Recommended Service Changes D. Implementation Approach

6. SECURITY REQUIREMENTS

Contractor personnel employed under this action will not receive FDA PIV badges. However, contractor personnel shall follow the instructions set forth in the OC/OO/OSEM/

OFFICE OF SECURITY OPERATIONS STANDARD OPERATING PROCEDURES FOR

VISITOR ACCESS MANAGEMENT.

7. GOVERNMENT FURNISHED INFORMATION (GFI)

A. Forms, Publications and Schedules. The Government will furnish all required Government forms, Government publications and shuttle schedules to the Contractor, as they are required by the Contract. Government publications include, but are not limited to, written FDA Staff Manual Guides, Federal regulations, and Federal Register issuances.

B. Passenger Counts. The Government will furnish passenger counts for all routes currently serviced by FDA Shuttles.

8. DELIVERABLES

The COR shall review Contractor deliverables in accordance with specifications and standards stated in the criteria established and any directives issued during the term of this contract. The COR has the authority to accept or reject deliverables.

The acceptance of deliverables and satisfactory work performance required herein shall be based upon the timeliness, accuracy, craftsmanship, and suitability of the deliverable. The specific deliverables and schedule for delivery shall be as agreed upon and documented.

Deliverables shall be submitted to the COR.

A final inspection and acceptance of all work performed, reports and other deliverables will be performed by the COR to ensure the services/products provided meet the requirements of the SOW at the time of delivery, and the Contractor shall make changes as requested during the inspection and acceptance process.

Inspection and acceptance will occur within ten (10) days of task being completed. The FDA will reject non-conforming products and services. The FDA will provide written notification of acceptance or rejection within ten (10) business days. Inspection will include review of the deliverables to ensure adequacy. The FDA will accept goods, reports and services only if they conform to all terms and conditions of the SOW and satisfy the performance standards developed under the SOW. The Contractor shall incorporate all FDA feedback and submit revised deliverables within five (5) business days of receipt. If the Contractor cannot correct the deficiencies within the five (5) day cycle, the Contractor shall immediately notify the COR of the reason for the delay and provide a proposed corrective action plan within five (5) business days.

Table 1: Task Order Deliverables Deliverable

ID

Deliverable

Title Quantity/ Frequency

Type (Formal/ Informal)

Deliverable Due Date

Kickoff Meeting Minutes

One Formal •No later than 10 working days of contract award

5A Section 1- Summary of Present and Future Transit Conditions

Draft, Draft Final and Final

Formal •Draft due per COR request •Draft Final due - 90 days following start of POP

• Final one week after COR approval of Draft Final

• Submitted electronically to Task

Order COR and Government Task Lead

5B Section 1- Transit Analysis

Draft, Draft Final and Final

Formal •Draft due per COR request •Draft Final due 90 days following start of POP

• Final one week after COR approval of Draft Final

• Submitted electronically to Task

Order COR and Government Task Lead

5C Section 1- Recommended for Service Changes

Draft, Draft Final and Final

Formal •Draft due per COR request •Draft Final due 90 days following start of POP

• Final one week after COR approval of Draft Final

• Submitted electronically to Task

Order COR and Government Task Lead

Deliverable

ID

Deliverable Title

Quantity/ Frequency

Type (Formal/ Informal)

Deliverable Due Date

5D Section 2- Implementation Approach

Draft, Draft Final and Final

Formal •Draft due per COR request •Draft Final due 90 days following start of POP

• Final one week after COR approval of Draft Final

• Submitted electronically to Task

Order COR and Government Task Lead

5E Section 2- Summary of Present and Future Transit Conditions

Draft, Draft Final and Final

Formal •Draft due per COR request •Draft Final due August 13, 2024

• Final one week after COR approval of Draft Final

• Submitted electronically to Task

Order COR and Government Task Lead

5F Section 2- Transit Analysis

Draft, Draft Final and Final

Formal •Draft due per COR request •Draft Final due August 13, 2024

• Final one week after COR approval of Draft Final

• Submitted electronically to Task

Order COR and Government Task Lead

5G Section 2- Recommended for Service Changes

Draft, Draft Final and Final

Formal •Draft due per COR request •Draft Final due August 13, 2024

• Final one week after COR approval of Draft Final

• Submitted electronically to Task

Order COR and Government Task Lead

5H Section 2- Implementation Approach

Draft, Draft Final and Final

Formal •Draft due per COR request •Draft Final due August 13, 2024

• Final one week after COR approval of Draft Final

• Submitted electronically to Task

Order COR and Government Task Lead

9. CONTRACT ADMINISTRATION

Contracting Officer’s Representative (COR) David Manchas David Manchas@fda.hhs.gov 301-796-4214

Contract Specialist (CS) Natapol Sirikhan Office of Acquisitions and Grants Services 4140 Powder Mill Road Beltsville, MD 20705 Telephone: 240-402-8031 Natapol.Sirikhan@fda.hhs.gov

Contracting Officer (CO) James Jenrette III

Office of Acquisitions and Grants Services 4140 Powder Mill Road Beltsville, MD 20705 Telephone: 301-837-7549 James.JenretteIII@fda.hhs.gov

9.1 CONTRACTING OFFICER’S AUTHORITY

The Contracting Officer (CO) is the only person authorized to approve changes in any of the requirements of this contract. In the event the Contractor effects any changes to this contract or contracts at the direction of any person other than the CO, the changes will be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof. The CO shall be the only individual authorized to accept nonconforming work, waive any requirement of the contract/task order and modify any term or condition of the contract/task order. The Contracting Officer is the only individual who can legally obligate Government funds. No costs chargeable to the proposed contract can be incurred before receipt of a fully executed contract or specific authorization from the Contracting Officer.

9.2 CONTRACTING OFFICER REPRESENTATIVE (COR)

The COR, to be designated at time of contract award, will represent the Government for the purpose of the contract The COR will be responsible for the following:

• Tracking compliance with Limitations on Subcontracting clause across contract

• Tracking and monitoring contract ceiling

• Tracking and monitoring staff allocation across contract

• Reviewing changes to staffing matrix

• Secondary point of contact for issues that need to be escalated

• Reviewing SOWs for scope compliance

• Completing annual CPARs evaluations mailto:David%20Manchas@fda.hhs.gov mailto:Natapol.Sirikhan@fda.hhs.gov mailto:James.JenretteIII@fda.hhs.gov

The COR shall serve as the Contractor’s first point of contact for any technical questions and is responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and compliance with all substantive project objectives; (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;

(5) assisting in the resolution of technical problems encountered during performance; and (6) providing technical direction; and, (7) reviewing of invoices/vouchers.

COR’s under this contract do not have authority to act as agents of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule;

(4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

The Government may unilaterally change its COR designation.

9.3 TECHNICAL DIRECTION

Performance of the work under this contract shall be subject to the technical direction of the COR.

The term “technical direction” is defined to include, without limitation, the following:

• Directions to the Contractor which redirect the contract effort, shift work emphasis between work areas or tasks, require pursuit of certain lines of inquiry, fill in details or otherwise serve to accomplish the contractual statement of work.

• Provision of information to the Contractor which assists in the interpretation of drawings, specifications, or technical portions of the work description.

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

Technical direction must be within the general Scope of Work stated in the contract. The COR does not have the authority to and may not issue any technical direction which:

• Constitutes an assignment of additional work outside the general Scope of Work of the contract.

• Constitutes a change as defined in the applicable contract clause entitled: FAR 52.243-3 “Changes–Time-and-Materials or Labor-Hours” (SEP 2000) (for LH Task Orders).

• Change any of the expressed terms, conditions, or specifications of the contract.

All technical direction will be issued in writing by the COR or will be confirmed by him/her in writing within five (5) business days after issuance.

9.4 INVOICE SUBMISSION

Invoicing instructions are prescribed under 352.232-71 Electronic Submission of Payment Requests (FEB 2022) and FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022).

a. 352.232-71 Electronic Submission of Payment Requests (FEB 2022)

(a) Definitions. As used in this clause—

Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request.

(END OF CLAUSE)

b. FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022)

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).

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 Items 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 http://www.ipp.gov/ http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/ mailto:ipp.noreply@mail.eroc.twai.gov mailto:IPPCustomerSupport@fiscal.treasury.gov 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.

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

• 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:

(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.

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 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.

(END OF CLAUSE)

10. CONTRACT CLAUSES

10.1 CONTRACT CLAUSES INCORPORATED BY REFERENCE – FAR 52.252-2 (FEB

1998)

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address:

http://www.acquisition.gov/comp/far/index.html and https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

FAR CLAUSES INCORPORATED BY REFERENCE

Reg Clause Date Clause Title

FAR 52.202-1 Nov 2013 Definitions FAR 52.203-3 Apr 1984 Gratuities FAR 52.203-5 May 2014 Covenant Against Contingent Fees FAR 52.203-7 May 2014 Anti-Kickback Procedures FAR 52.203-8 May 2014 Cancellation, Rescission, and Recovery of Funds for

Illegal or Improper Activity FAR 52.203-10 May 2014 Price or Fee Adjustment for Illegal or Improper Activity FAR 52.203-12 Oct 2010 Limitation on Payments to Influence Certain Federal Transactions FAR 52.203-17 Apr 2014 Contractor Employee Whistleblower Rights and Requirement to

Inform Employees of Whistleblower Rights (See Attachment 4 Addendum) FAR 52.203-19 Jan 2017 Prohibition on Requiring Certain Internal Confidentiality

Agreements or Statements FAR 52.204-4 May 2011 Printed or Copied Double-Sided on Recycled Paper FAR 52.204-7 Oct 2018 System for Award Management FAR 52.204-9 Jan 2011 Personal Identity Verification of Contractor Personnel FAR 52.204-13 Oct 2018 System for Award Management Maintenance FAR 52.204-19 Dec 2014 Incorporation by Reference of Representation and Certifications FAR 52.209-6 Oct 2015 Protecting the Government's Interests When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment FAR 52.209-10 Nov 2015 Prohibition on Contracting with Inverted Domestic Corporations mailto:ERIC@fda.hhs.gov https://www.hhs.gov/grants/contracts/contract-%20policies-regulations/hhsar/index.html https://www.hhs.gov/grants/contracts/contract-%20policies-regulations/hhsar/index.html

FAR 52.215-2 Oct 2010 Audit and Records – Negotiation FAR 52.215-14 Oct 2010 Integrity of Unit Prices FAR 52.219-8 Nov 2016 Utilization of Small Business Concerns FAR 52.222-3 Jun 2003 Convict Labor FAR 52.222-21 Apr 2015 Prohibition of Segregated Facilities FAR 52.222-26 Sept 2016 Equal Opportunity FAR 52.222-35 Oct 2015 Equal Opportunity for Veterans FAR 52.222-36 Jul 2014 Equal Opportunity for Workers with Disabilities FAR 52.222-37 Feb 2016 Employment Reports on Veterans FAR 52.222-40 Dec 2010 Notification of Employee Rights Under the National Labor Relations Act FAR 52.222-41 May 2014 Service Contract Labor Standards FAR 52.222-43 May 2014 Fair Labor Standards Act and Service Contract Labor Standards- Price Adjustment (Multiple Year and Option Contracts).

FAR 52.222-50 Mar 2015 Combating Trafficking in Persons FAR 52.222-54 Oct 2015 Employment Eligibility Verification FAR 52.223-6 May 2001 Drug-Free Workplace FAR 52.224-1 Apr 1984 Privacy Act Notification FAR 52.225-13 Jun 2008 Restrictions on Certain Foreign Purchases FAR 52.227-14 May 2014 Rights in Data – General FAR 52.227-16 June 1987 Additional Data Requirements FAR 52.232-1 Apr 1984 Payments FAR 52.232-9 Apr 1984 Limitation on Withholding of Payments FAR 52.232-23 May 2014 Assignment of Claims FAR 52.232-25 Jan 2017 Prompt Payment FAR 52.232-33 Oct 2018 Payment by Electronic Funds Transfer—System for Award

Management FAR 52.232-39 Jun 2013 Unenforceability of Unauthorized Obligations FAR 52.233-1 May 2014 Disputes FAR 52.233-3 Aug 1996 Protest After Award FAR 52.233-4 Oct 2004 Applicable Law for Breach of Contract Claim FAR 52.237-2 Apr 1984 Protection of Government Buildings, Equipment, and Vegetation FAR 52.242-13 Jul 1995 Bankruptcy FAR 52.243-1 Aug 1987 Changes – Fixed Price, Alt I FAR 52.244-2 Oct 2010 Subcontracts FAR 52.245-1 Jan 2017 Government Property FAR 52.245-9 Apr 2012 Use and Charges FAR 52.246-25 Feb 1997 Limitation of Liability—Services FAR 52.249-2 Apr 2012 Termination for Convenience of the Government (Fixed-Price) FAR 52.249-6 May 2004 Termination (Cost-Reimbursement), and Alt. IV (Sep 1996) FAR 52.249-8 Apr 1984 Default (Fixed-Price Supply and Service) FAR 52.249-14 Apr 1984 Excusable Delays FAR 52.253-1 Jan 1991 Computer Generated Forms

10.2 HHSAR CLAUSES INCORPORATED BY REFERENCE

Reg Clause Date Clause Title

HHSAR 352.203-70 Dec 2015 Anti-Lobbying HHSAR 352.208-70 Dec 2015 Printing and Duplication HHSAR 352.222-70 Dec 2015 Contractor Cooperation in Equal Employment Opportunity

Investigations HHSAR 352.227-70 Dec 2015 Publications and Publicity HHSAR 352.231-70 Dec 2015 Salary Rate Limitation HHSAR 352.233-71 Dec 2015 Litigation and Claims

HHSAR 352.239-74 Electronic Information and Technology Accessibility Notice (DEC 2015) This clause applies with the following addenda:

(c) The Section 508 accessibility standards applicable to this contract will be provided at the task order level, if applicable

10.3 FAR CLAUSES IN FULL-TEXT

52.217-8 Option to Extend Service (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 any time before the contract expires.

(End of clause)

52.217-9 Option to Extend the Term of the Contract (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor at any time prior to the contract expiration date, provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 3 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 3 years.

(End of clause)

10.4 HHSAR CLAUSES IN FULL TEXT

HHSAR 352.224-71 Confidential Information (DEC 2015)

(a) Confidential Information, as used in this clause, means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.

(b) Specific information or categories of information that the Government will furnish to the Contractor, or that the Contractor is expected to generate, which are confidential may be identified elsewhere in this contract. The Contracting Officer may modify this contract to identify Confidential Information from time to time during performance.

(c) Confidential Information or records shall not be disclosed by the Contractor until:

(1) Written advance notice of at least 45 days shall be provided to the Contracting Officer of the Contractor's intent to release findings of studies or research, to which an agency response may be appropriate to protect the public interest or that of the agency.

(2) For information provided by or on behalf of the government,

(i) The publication or dissemination of the following types of information are restricted under this contract: Procurement sensitive or budgetary information

(ii) The reason(s) for restricting the types of information identified in subparagraph (i) is/are:

Information that is not releasable under the Freedom of Information Act (FOIA) and source selection sensitive (FAR 2.101 and 3.104)

(iii) Written advance notice of at least 45 days shall be provided to the Contracting Officer of the Contractor's intent to disseminate or publish information identified in subparagraph (2)(i). The contractor shall not disseminate or publish such information without the written consent of the Contracting Officer.

(d) Whenever the Contractor is uncertain with regard to the confidentiality of or a property interest in information under this contract, the Contractor should consult with the Contracting Officer prior to any release, disclosure, dissemination, or publication.

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 (30) day 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. For the purposes of the resultant contract, the IDIQ Program Manager shall be considered key personnel. Key personnel may also be designated in task orders by labor category, role or function. The following Key Personnel and are considered to be essential to the work being performed in the contract. Additional Key Personnel will be identified in each task order award.

Title Name TBD To be Determined at time of Award TBD To be Determined at time of Award

11. REPRESENTATIONS AND INSTRUCTIONS

11.1 REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF

OFFERORS

The Representations and Certifications required by this acquisition can be accessed through the System for Award Management (SAM) on the Internet at the following address: www.sam.gov.

If you are unable to access this document, you may request a copy from the Contracting Officer identified on the cover page of this solicitation.

***OFFERORS SUBMITTING A PROPOSAL MUST COMPLETE THE REPRESENTATIONS

AND CERTIFICATIONS ON-LINE.***

11.2 FAR PROVISION IN FULL TEXT

52.204-8 Annual Representation and Certifications (OCT 2018)

(a)

(1) The North American Industry classification System (NAICS) code for this acquisition is 485999

(2) The small business size standard is $15.0 million

(3) The small business size standard for a concern which submits an offer in its own name, other than on a construction or service contract, but which proposes to furnish a product which it did not itself manufacture, is 500 employees.

(b)

(1) If the provision at 52.204-7, System for Award Management, is included in this solicitation, paragraph (d) of this provision applies.

(2) If the provision at 52.204-7, System for Award Management, is not included in this solicitation, and the Offeror has an active registration in the System for Award Management (SAM), the Offeror may choose to use paragraph (d) of this provision instead of completing the corresponding individual representations and certifications in the solicitation. The Offeror shall indicate which option applies by checking one of the following boxes:

[x] (i) Paragraph (d) applies.

[_] (ii) Paragraph (d) does not apply and the offeror has completed the individual representations and certifications in the solicitation.

(c)

(1) The following representations or certifications in SAM are applicable to this solicitation as indicated:

http://www.sam.gov/

(i) 52.203-2, Certificate of Independent Price Determination. This provision applies to solicitations when a firm-fixed-price contract or fixed-price contract with economic price adjustment is contemplated, unless—

(A) The acquisition is to be made under the simplified acquisition procedures in Part 13;

(B) The solicitation is a request for technical proposals under two-step sealed bidding procedures; or

(C) The solicitation is for utility services for which rates are set by law or regulation.

(ii) 52.203-11, Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions. This provision applies to solicitations expected to exceed $150,000.

(iii) 52.203-18, Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements—Representation. This provision applies to all solicitations.

(iv) 52.204-3, Taxpayer Identification. This provision applies to solicitations that do not include the provision at 52.204-7, System for Award Management.

(v) 52.204-5, Women-Owned Business (Other Than Small Business). This provision applies to solicitations that—

(A) Are not set aside for small business concerns;

(B) Exceed the simplified acquisition threshold; and

(C) Are for contracts that will be performed in the United States or its outlying areas.

(vi) 52.209-2, Prohibition on Contracting with Inverted Domestic Corporations— Representation.

(vii) 52.209-5; Certification Regarding Responsibility Matters. This provision applies to solicitations where the contract value is expected to exceed the simplified acquisition threshold.

(viii) 52.209-11, Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law. This provision applies to all solicitations.

(ix) 52.214-14, Place of Performance--Sealed Bidding. This provision applies to invitations for bids except those in which the place of performance is specified by the Government.

(x) 52.215-6, Place of Performance. This provision applies to solicitations unless the place of performance is specified by the Government.

(xi) 52.219-1, Small Business Program Representations (Basic & Alternate I). This provision applies to solicitations when the contract will be performed in the United States or its outlying areas.

(A) The basic provision applies when the solicitations are issued by other than DoD, NASA, and the Coast Guard.

(B) The provision with its Alternate I applies to solicitations issued by DoD, NASA, or the Coast Guard.

(xii) 52.219-2, Equal Low Bids. This provision applies to solicitations when contracting by sealed bidding and the contract will be performed in the United States or its outlying areas.

(xiii) 52.222-22, Previous Contracts and Compliance Reports. This provision applies to solicitations that include the clause at 52.222-26, Equal Opportunity.

(xiv) 52.222-25, Affirmative Action Compliance. This provision applies to solicitations, other than those for construction, when the solicitation includes the clause at 52.222-26, Equal Opportunity.

(xv) 52.222-38, Compliance with Veterans' Employment Reporting Requirements. This provision applies to solicitations when it is anticipated the contract award will exceed the simplified acquisition threshold and the contract is not for acquisition of commercial items.

(xvi) 52.223-1, Biobased Product Certification. This provision applies to solicitations that require the delivery or specify the use of USDA-designated items; or include the clause at 52.223-2, Affirmative Procurement of Biobased Products Under Service and Construction Contracts.

(xvii) 52.223-4, Recovered Material Certification. This provision applies to solicitations that are for, or specify the use of, EPA- designated items.

(xviii) 52.223-22, Public Disclosure of Greenhouse Gas Emissions and Reduction Goals— Representation. This provision applies to solicitations that include the clause at 52.204-7.

(xix) 52.225-2, Buy American Certificate. This provision applies to solicitations containing the clause at 52.225-1.

(xx) 52.225-4, Buy American--Free Trade Agreements--Israeli Trade Act Certificate. (Basic, Alternates I, II, and III.) This provision applies to solicitations containing the clause at 52.225- 3.

(A) If the acquisition value is less than $25,000, the basic provision applies.

(B) If the acquisition value is $25,000 or more but is less than $50,000, the provision with its Alternate I applies.

(C) If the acquisition value is $50,000 or more but is less than $80,317, the provision with its Alternate II applies.

(D) If the acquisition value is $80,317 or more but is less than $100,000, the provision with its Alternate III applies.

(xxi) 52.225-6, Trade Agreements Certificate. This provision applies to solicitations containing the clause at 52.225-5.

(xxii) 52.225-20, Prohibition on Conducting Restricted Business Operations in Sudan-- Certification. This provision applies to all solicitations.

(xxiii) 52.225-25, Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran—Representation and Certification. This provision applies to all solicitations.

(xxiv) 52.226-2, Historically Black College or University and Minority Institution Representation.

This provision applies to solicitations for research, studies, supplies, or services of the type normally acquired from higher educational institutions.

(2) The following representations or certifications are applicable as indicated by the Contracting Officer: [Contracting Officer check as appropriate.]

(i) 52.204-17, Ownership or Control of Offeror.

(ii) 52.204-20, Predecessor of Offeror.

(iii) 52.222-18, Certification Regarding Knowledge of Child Labor for Listed End

Products.

(iv) 52.222-48, Exemption from Application of the Service Contract Labor Standards to

Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Certification.

(v) 52.222-52 Exemption from Application of the Service Contract Labor Standards to

Contracts for Certain Services--Certification.

(vi) 52.223-9, with its Alternate I, Estimate of Percentage of Recovered Material Content for EPA- Designated Products (Alternate I only).

(vii) 52.227-6, Royalty Information.

(A) Basic.

(B) Alternate I.

(viii) 52.227-15, Representation of Limited Rights Data and Restricted Computer Software.

(d) The Offeror has completed the annual representations and certifications electronically in SAM accessed through https://www.sam.gov. After reviewing the SAM information, the Offeror verifies by submission of the offer that the representations and certifications currently posted electronically that apply to this solicitation as indicated in paragraph (c) of this provision have been entered or updated within the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard applicable to the NAICS code referenced for this solicitation), as of the date of this offer and are incorporated in this offer by reference (see FAR 4.1201); except for the changes identified below [offeror to insert changes, identifying change by clause number, title, date]. These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer.

FAR Clause Title Date Change

Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted on SAM.

(End of Provision)

52.209-11 Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law. (Feb 2016)

(a) As required by sections 744 and 745 of Division E of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235), and similar provisions, if contained in subsequent appropriations acts, the Government will not enter into a contract with any corporation that—

(1) Has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability, where the awarding agency is aware of the unpaid tax liability, unless an agency has considered suspension or debarment of the corporation and made a determination that suspension or debarment is not necessary to protect the interests of the Government; or

(2) Was convicted of a felony criminal violation under any Federal law within the preceding 24 months, where the awarding agency is aware of the conviction, unless an agency has considered suspension or debarment of the corporation and made a determination that this action is not necessary to protect the interests of the Government.

(b) The Offeror represents that—

(1) It is □ is not □ a…