RFP - 75F40123R00131.pdf

SEE ADDENDUMIS CHECKED

CODE 18a. PAYMENT WILL BE MADE BY

CODE

FACILITYCODE

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

OFFEROR

CODE 16. ADMINISTERED BYCODE

X

X

SIZE STANDARD:

% FOR:SET ASIDE:UNRESTRICTED ORDAO

REQUEST FOR

PROPOSAL

(RFP)

INVITATION

FOR BID (IFB)

10. THIS ACQUISITION ISCODE

REQUEST FOR

QUOTE (RFQ)

14. METHOD OF SOLICITATION

13b. RATING

NORTH AMERICAN INDUSTRY

CLASSIFICATION STANDARD

(NAICS):

SMALL BUSINESS

08/14/2023 1200 ET

07/28/2023

NATAPOL SIRIKHAN

(No collect calls)

INFORMATION CALL:

FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIMEb. TELEPHONE NUMBER a. NAME

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

75F40123R00131

5. SOLICITATION NUMBER

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

1 2 OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

TELEPHONE NO.

17a. CONTRACTOR/

15. DELIVER TO

Beltsville MD 20705 4041 Powder Mill Road ATTN: Natapol Sirikhan

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

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

ISSUE DATE

DELIVERY FOR FREE ON BOARD

(FOB) DESTINATION UNLESS

BLOCK IS MARKED

11.

SEE SCHEDULE

12. DISCOUNT TERMS THIS CONTRACT IS A RATED

ORDER UNDER THE DEFENSE

PRIORITIES AND ALLOCATIONS

SYSTEM - DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

(SDVOSB)

HUBZONE SMALL

BUSINESS

8(A)

DHHS/FDA/OAGS/DAO

WOMEN-OWNED SMALL

BUSINESS (WOSB)

ECONOMICALLY DISADVANTAGED

WOMEN-OWNED SMALL

BUSINESS (EDWOSB)

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

See Attached SOW

(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 (FEDERAL ACQUISITION REGULATION) FAR 52.212-1, 52.212-4. FAR 52.212-3

AND 52.212-5 ARE ATTACHED. ADDENDA

26. TOTAL AWARD AMOUNT (For Government Use Only)

OFFER

STANDARD FORM 1449 (REV. 11/2021)

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: REFERENCE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32c. DATE 32b. SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

40. PAID BY39. S/R VOUCHER NUMBER38. S/R ACCOUNT NUMBER

37. CHECK NUMBER

FINALPARTIAL

36. PAYMENT

FINALPARTIAL

35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER33. SHIP NUMBER

COMPLETE

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

42d. TOTAL CONTAINERS42c. DATE REC'D (YY/MM/DD)

42b. RECEIVED AT (Location)

42a. RECEIVED BY (Print)

41c. DATE41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

STANDARD FORM 1449 (REV. 11/2021) BACK

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

2 2 of

STATEMENT OF WORK

TITLE: “RESEARCH GAP ANALYSIS SCOPING REVIEW”

1. OBJECTIVE

The purpose of this effort is to complete a scoping review on the availability of scientific data/evidence in the peer-reviewed literature on arsenic, lead, cadmium, and mercury and agricultural production of food for human consumption.

2. BACKGROUND

The U.S. Food and Drug Administration (FDA) has a long history of work in the space of contaminants.

In recent years, the Closer to Zero initiative has laid out an action plan of steps FDA is taking to reduce exposure to children to four environmental contaminants found in food - arsenic, lead, cadmium, and mercury. FDA has prioritized these four elements due to their relative toxicity, prevalence in the food supply, and the relative contribution of food as a source of exposure. We also prioritize young children because of the impact exposure can have on development, particularly neurodevelopment.

This is a complex issue not only because of the serious nature of protecting child development, but because environmental contaminants are found in foods that are part of healthy dietary patterns, such as vegetables, fruits, grains, and seafood, and are also known to pass into human milk. Infant formula and the water used to prepare it are also possible sources of contaminant exposures, It is also a complex issue because many environmental contaminants found in foods are naturally part of the soil, water, and air where food is grown or raised. Human activities also contribute to levels found in the environment.

Driving levels down in the food supply is challenging and complex.

A collaboration exists between the U.S. Department of Agriculture (USDA) and the FDA as part of the Closer to Zero initiative. For example, the USDA National Institute of Food and Agriculture (NIFA) provides leadership and funding for programs that advance agriculture-related sciences. NIFA supports initiatives that ensure the long-term viability of agriculture. NIFA applies an integrated approach to ensure that groundbreaking discoveries in agriculture-related sciences and technologies reach the people who can put them into practice. NIFA and FDA developed methodology and conducted a scoping review to discern what is and is not currently know in the published peer-reviewed literature on arsenic, lead, cadmium, and mercury and agricultural production of food for human consumption. The review retrieved a large body of evidence, warranting additional support for completing and disseminating the findings of the scoping review.

3. SCOPE

The Contractor shall establish a team of scientific experts in systematic review and that includes expertise in the scientific disciplines of nutrition, toxicology, and evidence integration and synthesis to conduct a study of the availability of scientific data/evidence in the peer-reviewed literature on arsenic, lead, cadmium, and mercury in agricultural production of food for human consumption as it relates to the category of topics of 1) soil amendments, growing and growth conditions, harvest practices, and related scientific topics; 2) the content in foods, including grains, vegetables, fruits, seafood (fish and shellfish), meat and poultry, and fermented foods; 3) technology and methodology, such as detection methods and manufacturing methods; and 4) consumer exposure and related nutrition exposures. The Contractor shall produce a report with supporting evidence tables and documentation. To accomplish this objective, the

Contractor shall conduct a literature scoping review of the scientific literature and describe the available evidence related to the categories of topics aforementioned.

4. TASKS

The Contractor shall furnish all necessary services and qualified personnel not otherwise provided by CFSAN, as needed to perform the requirements of this award.

Task 1 – Kick-off Meeting

• Within ten (10) working days from the effective award date, the Contractor shall conduct a kick-off meeting via teleconference call with the Contracting Officer’s Representative (COR) to discuss the scope, goals of the project, milestones, timeline of activities, customized work, and allocated resources and deliverables as outlined in the order. The interested parties shall include the Contractor’s project director and support staff assigned to the project, the COR and other persons deemed necessary.

• The Contractor shall submit detailed discussion notes and minutes within seven (7) working days from the kick-off meeting.

• Within five (5) working days from the first meeting, the Contractor shall coordinate a second meeting, if necessary, via teleconference with the COR.

• The Contractor shall submit detailed discussion notes and minutes within seven (7) working days from the kick-off meeting.

Task 2 – Project Management

The Contractor shall:

• Provide written updates on the status of the project, project timelines, and work toward completion of tasks in monthly reports.

• Propose an overarching project schedule for all tasks; and

• Maintain effective communication with the FDA CFSAN Project Lead during the period of performance.

Task 3 – Scoping Literature Review

At a minimum, the Contractor shall:

• Consider existing sources of publicly available information on categories of topics proposed by

FDA.

• Review the methodology and scoping review studies retrieved for consideration in the development of a research plan

• Develop, execute, and document a research plan for conducting a scoping literature review of peer-reviewed literature of categories of topics in the scope of this work. The research plan will include the search strategy, search years, search terms, inclusion and exclusion criteria, and data extraction protocols and, upon completion of the work, deliver documentation to the COR of the methodology and findings, including data extraction tables and summaries, if not part of the final report.

• Gather information from published peer-reviewed literature through scoping literature reviews and informed by consultation with FDA, as needed; and

• Summarize the available evidence for categories of topics within the scope of this work.

Task 4 – Research Recommendations

At a minimum, the Contractor shall describe areas of scientific knowledge that are lacking or inadequately robust and develop research recommendations with the potential to help close those research gaps.

Task 5 –Study Report

At a minimum, the Contractor shall:

• Provide a draft report and a presentation to FDA on the tasks and deliverables in scope of this contract, specifically the findings.

• Provide a final report to FDA with supporting tables and other files.

• Produce a manuscript for publication in a peer-reviewed journal.

5. DELIVERABLES

The Contractor shall provide deliverables to the COR on the due dates specified in Table 1. All deliverables shall be provided via e-mail in a Microsoft Word Document or PDF File format.

Table 1. Deliverables/Schedule

Be advised that FDA does not accept documents which contain the use of macros. When submitting documents via email, DO NOT include .exe, .mso, or any other executable file types that could

Task # Deliverables Due Date

Task 1

Kick-off Meeting Within ten (10) working days after date of award.

Kick-off Meeting Notes and Meeting Minutes Within seven (7) working days of the kick-off meeting.

Second Meeting As agreed upon between the parties.

Second Meeting Notes and Meeting Minutes Within seven (7) working days of the second meeting.

Task 2 Project Schedule Within seven days (7) working days of the kick-off meeting or second meeting if required.

Monthly Reports By the 5th of each month.

Task 3 Research Plan As agreed upon between the parties.

Task 4 Research Gap Recommendations As agreed upon between the parties.

Task 5 Draft Report & Presentation As agreed upon between the parties.

Final Report No later than two (2) working days before the award expiration date.

Manuscript No later than two (2) working days before the award expiration date.

potentially trigger email security protections (i.e. email blocks, quarantine). Document submissions required throughout the award period(s) shall not have macro enabled functionality and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

6. PLACE OF PERFORMANCE

The Contractor shall perform these duties primarily off-site for the duration of the effort and on-site as requested by COR at the following address:

5001 Campus Drive College Park, MD 20705

7. PERIOD OF PERFORMANCE

The period of performance shall include a base period of twelve (12) months.

8. TYPE OF CONTRACT

The resultant award will be a Labor-Hour call order.

9. HOLIDAYS AND GOVERNMENT CLOSURES

The Contractor is not required to provide on-site services on the following days that are Federal Holidays or on any other day designated as a Federal holiday for the Washington, D.C. area:

New Year's Day Martin Luther King Day President 's Day Memorial Day Juneteenth Independence Day Labor Day Columbus Day Veteran 's Day Thanksgiving Day Christmas Day

The Contractor may not bill the Government for any hours that the Contractor did not work due to any Government closure.

10. SECTION 508 COMPLIANCE

Section 508 of the Rehabilitation Act of 1973 (29. U.S.C. 794d), as amended by the Workforce Investment Act 1998, requires that all electronic and information technology (EIT) products and services developed, acquired, maintained, or used under this award must comply with the “Electronic and Information Technology Accessibility Provisions” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194. Information about Section 508 is available at http://www.access-board.gov/guidelines-andstandards/commications-and-it/about-the-section-508-standards. This requirement is shall comply with the following standards.

• E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

• E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

• E204 Functional Performance (Appendix A, Application and Scoping Requirements)

• E205 Electronic Content (Appendix A, Application and Scoping Requirements)

• 302 Functional Performance (Appendix C, Functional Performance Criteria and Technical Requirements)

• Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed a https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except up approval of the Contract Officer or Representative.

• E207 Software (Appendix A, Application and Scoping Requirements)

• E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements)

• Chapter 5 Software (Appendix C, Functional Performance Criteria and Technical Requirements)

• Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and Technical Requirements) All EIT must meet the applicable accessibility standards at 36 CFR 1194, unless an agency exception to this requirement exists. 36 CFR 1194 implements Section 508 of the Rehabilitation Act of 1973, as amended, and is viewable at: https://www.section508.gov/.

10. POINTS OF CONTACT

Contracting Officer Representative:

Kellie Casavale, PhD, RD (kellie.oconnell@fda.hhs.gov T: 240.461.9712 Senior Science Advisor Office of Analytics and Outreach, Center for Food Safety and Applied Nutrition US Food and Drug Administration 5001 Campus Drive, Harvey W. Wiley Building (CPK 1) College Park, MD 20740-3835

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 mailto:kellie.oconnell@fda.hhs.gov mailto:Natapol.Sirikhan@fda.hhs.gov mailto:James.JenretteIII@fda.hhs.gov

Contracting Officer’s Authority

The Contracting Officer (CO) is the only person authorized to approve changes in any of the requirements of this contract/task order/BPA call. In the event the Contractor effects any changes to this contract/task order/BPA call 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/task order/BPA call 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/BPA call 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.

Contracting Officer’s Representative (COR)

The COR, to be designated at time of contract award, will represent the Government for the purpose of the contract/task order/BPA call. The COR will be responsible for the following:

• Tracking compliance with Limitations on Subcontracting clause across contract/task order/BPA

Call

• Tracking and monitoring contract/task order/BPA call ceiling

• Tracking and monitoring staff allocation across contract/task order/BPA call

• 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

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/task order/BPA call 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.

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.

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 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 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 https://www.ipp.gov/ mailto:ipp.noreply@mail.eroc.twai.gov mailto:IPPCustomerSupport@fiscal.treasury.gov 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)

11. CLAUSES

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 Fund 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 mailto:ERIC@fda.hhs.gov https://www.hhs.gov/grants/contracts/contract-%20policies-regulations/hhsar/index.html

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 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

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

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)

52.204-27 Prohibition on a ByteDance Covered Application (JUN 2023)

(a) Definitions. As used in this clause—

Covered application means the social networking service TikTok or any successor application or service developed or provided by ByteDance Limited or an entity owned by ByteDance Limited.

Information technology, as defined in 40 U.S.C. 11101(6)—

(1) Means any equipment or interconnected system or subsystem of equipment, used in the automatic acquisition, storage, analysis, evaluation, manipulation, management, movement, control, display, switching, interchange, transmission, or reception of data or information by the executive agency, if the equipment is used by the executive agency directly or is used by a contractor under a contract with the executive agency that requires the use—

(i) Of that equipment; or

(ii) Of that equipment to a significant extent in the performance of a service or the furnishing of a product;

(2) Includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources; but

(3) Does not include any equipment acquired by a Federal contractor incidental to a Federal contract.

(b) Prohibition. Section 102 of Division R of the Consolidated Appropriations Act, 2023 (Pub. L. 117- 328), the No TikTok on Government Devices Act, and its implementing guidance under Office of Management and Budget (OMB) Memorandum M-23-13, dated February 27, 2023, “No TikTok on Government Devices” Implementation Guidance, collectively prohibit the presence or use of a covered application on executive agency information technology, including certain equipment used by Federal contractors. The Contractor is prohibited from having or using a covered application on any information technology owned or managed by the Government, or on any information technology used or provided by the Contractor under this contract, including equipment provided by the Contractor’s employees;

however, this prohibition does not apply if the Contracting Officer provides written notification to the Contractor that an exception has been granted in accordance with OMB Memorandum M-23-13.

(c) Subcontracts. The Contractor shall insert the substance of this clause, including this paragraph (c), in all subcontracts, including subcontracts for the acquisition of commercial products or commercial services.

(End of clause)

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

12. REPRESENTATIONS AND INSTRUCTIONS

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.***

FAR Provisions 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:

(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— http://www.sam.gov/

(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.

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…