RFP 75R60222R00018 (SCTOD) - 06.03.22.pdf

75R60222R00018

SOLICITATION, OFFER AND AWARD

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

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

ORDER UNDER DPAS (15 CFR 700)

6. REQUISITION/PURCHASE NUMBER

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

NEGOTIATED (RFP)

SEALED BID (IFB)

5. DATE ISSUED

1. THIS CONTRACT IS A RATED RATING PAGE OF PAGES

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C. E-MAIL ADDRESS

EXT.NUMBERAREA CODE

B. TELEPHONE (NO COLLECT CALLS)A. NAME

10. FOR

INFORMATION

CALL:

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

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

SOLICITATION

9. Sealed offers in original and

PART IV - REPRESENTATIONS AND INSTRUCTIONS

OTHER STATEMENTS OF OFFERORS

EVALUATION FACTORS FOR AWARD

INSTRS., CONDS., AND NOTICES TO OFFERORS

REPRESENTATIONS, CERTIFICATIONS AND

LIST OF ATTACHMENTS

CONTRACT CLAUSES

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

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J

K

L

M SPECIAL CONTRACT REQUIREMENTS

CONTRACT ADMINISTRATION DATA

DELIVERIES OR PERFORMANCE

INSPECTION AND ACCEPTANCE

PACKAGING AND MARKING

DESCRIPTION/SPECS./WORK STATEMENT

SUPPLIES OR SERVICES AND PRICES/COSTS

SOLICITATION/CONTRACT FORM

PART II - CONTRACT CLAUSESPART I - THE SCHEDULE

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G

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A

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

11. TABLE OF CONTENTS

18. OFFER DATE17. SIGNATURE

SUCH ADDRESS IN SCHEDULE.

IS DIFFERENT FROM ABOVE - ENTER

15C. CHECK IF REMITTANCE ADDRESS

EXT.NUMBERAREA CODE

15B. TELEPHONE NUMBER

(Type or print)AND

ADDRESS

OF

OFFEROR

CODE

FACILITY

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

DATEAMENDMENT NO.DATEAMENDMENT NO.

and related documents numbered and dated):

amendments to the SOLICITATION for offerors

(The offeror acknowledges receipt of

14. ACKNOWLEDGEMENT OF AMENDMENTS

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

(See Section I, Clause No. 52.232.8)

13. DISCOUNT FOR PROMPT PAYMENT

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

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

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

OFFER (Must be fully completed by offeror)

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

28. AWARD DATE

(Signature of Contracting Officer)

27. UNITED STATES OF AMERICA

25. PAYMENT WILL BE MADE BY

26. NAME OF CONTRACTING OFFICER (Type or print)

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

ITEM

(4 copies unless otherwise specified)

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

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

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

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

AWARD (To be completed by government)

CODE

06/03/2022 X

OAMP

HHS/HRSA/OO/OAMP

Office of Acquisition Management and Policy 5600 Fishers Lane, Rm 14W26B Rockville MD 20857

1200 EST 06/29/2022

NAOMI L INAZAWA

NInazawa@hrsa.gov

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PAGE(S)

JIMMY K. HUPALAR

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is unusable

STANDARD FORM 33 (Rev. 9-97)

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

12. In compliance with the above, the undersigned agrees, if this offer is accepted within _____0_________ calendar days (60 calendar days unless a different period is inserted

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

2 2

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

75R60222R00018

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

Title: Stem Cell Therapeutic Outcomes Database

(SCTOD)

Procurement ID#: HSB116 C 3681

Contract Type: Firm-Fixed Price

This is a Request for Proposal (RFP) for the Stem

Cell Therapeutic Outcomes Database (SCTOD) utilizing Federal Acquisition Regulation (FAR)

Part 15 under NAICS 541990, All Other

Professional, Scientific and Technical Services.

Provide the following information:

1. Contact Name: ____________________________

2. Phone Number: ____________________________

3. Email Address: ____________________________

4. UEI Number: ____________________________

Questions are due June 9, 2022 at 12:00PM EST.

Proposals are due June 29, 2022 at 12:00PM EST.

CONTRACT SPECIALIST:

Naomi Inazawa

Email: NInazawa@hrsa.gov

Phone: 240-461-7245

ATTACHMENTS:

A - Performance Work Statement (PWS)

B - Invoice Instructions

C - CPARS Information Sheet

D - Disclosure of Lobbying Activities

E - Past Performance Questionnaire

F - Contractor Non-Disclosure Agreement

G - HHS Small Business Subcontracting Plan

OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

NSN 7540-01-152-8067

DRAFT

RFP: 75R60222R00018

SCTOD

SECTION A – STANDARD FORM (SF) 33

This page is left blank intentionally.

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

B.1. Purpose of Contract

The Health Resources and Services Administration (HRSA) is seeking a contractor to provide statistical and other analytic support to the CW Bill Young Cell Transplantation Program’s (CWBYCTP) Stem Cell Therapeutic Outcomes Database (SCTOD).

B.2. Compensation Cost/Price

B.2.1. In consideration of the satisfactory performance of the services and tasks detailed in Section J– Attachment A- Performance Work Statement, the Contractor shall be compensated in accordance with the following amounts:

a. Base Period (Period of Performance September 27, 2022 – September 26, 2023) The price to the Government for full performance of the base period under this contract will be

b. Option Period One (Period of Performance September 27, 2023 – September 26, 2024)

The price to the Government for full performance of Option Period One, if exercised, under this contract will be $_____________.

c. Option Period Two (Period of Performance September 27, 2024 – September 26, 2025)

The price to the Government for full performance of Option Period Two, if exercised, under this

d. Option Period Three (Period of Performance September 27, 2025 – September 26, 2026)

The price to the Government for full performance of Option Period Three, if exercised, under this

e. Option Period Four (Period of Performance September 27, 2026 – September 26, 2027)

The price to the Government for full performance of Option Period Four, if exercised, under this

f. Option to extend for 6 Months in accordance with FAR Clause 52.217-8 Options to Extend

Services.

The cost to the Government for full performance of Optional to extend, if exercised, under this contract will be $___________.

g. Optional Task. The cost to the Government for full performance of Optional Task, if exercised, under this contract will be $___________.

B.2.2. The total price for the Base Period and all options is $___________.

SECTION C – DESCRIPTION/SPECIFICATIONS/ STATEMENT OF WORK

C.1 Performance Work Statement

Independently and not as an agent of the Government, the Contractor shall furnish all personnel, material, facilities, services, and equipment as needed to perform the Performance Work Statement forth in Section J (Attachment A) attached hereto and made part of this document.

SECTION D – PACKAGING AND MARKING

D.1 Packaging

All postage and fees related to submitting information including forms, reports, etc. to the Contracting Officer or Contracting Officer Representative (COR) are the responsibility of the contractor.

All submission shall be made via electronic mail unless othererwise specified by the CO or the COR designated in the contract.

D.2 Marking

All reports and documents shall have, at a minimum in the document header, the contract number, and the COR’s name. All reports and documents shall have, at a minimum in the document footer, the author in the lower left corner, the page # of total # of pages in the center bottom of the page, and the date and /or version of the document (not the auto date) in the lower right corner.

The Contractor shall deliver all items at the time indicated in the Deliverables Schedule.

a. All deliverable reports are to carry at the top of the first page the following information:

1) Contract number

2) Deliverable item number

3) Deliverable item delivery due date

4) Date of submission

SECTION E – INSPECTION AND ACCEPTANCE

E.1 Inspection and Acceptance

The Contracting Officer Representative (COR), as a duly authorized representative of the Contracting Officer, shall assume the responsibilities for monitoring the Contractor’s performance, evaluating the quality of services provided by the Contractor and performing final inspection and acceptance of all deliverables.

E.2 52.246-4 -- Inspection of Services – Fixed Price (Aug 1996)

(a) Definition. "Services," as used in this clause, includes services performed, workmanship, and material furnished or utilized in the performance of services.

(b) The Contractor shall provide and maintain an inspection system acceptable to the Government covering the services under this contract. Complete records of all inspection work performed by the Contractor shall be maintained and made available to the Government during contract performance and for as long afterwards as the contract requires.

(c) The Government has the right to inspect and test all services called for by the contract, to the extent practicable at all times and places during the term of the contract. The Government shall perform inspections and tests in a manner that will not unduly delay the work.

(d) If the Government performs inspections or tests on the premises of the Contractor or a subcontractor, the Contractor shall furnish, and shall require subcontractors to furnish, at no increase in contract price, all reasonable facilities and assistance for the safe and convenient performance of these duties.

(e) If any of the services do not conform with contract requirements, the Government may require the Contractor to perform the services again in conformity with contract requirements, at no increase in contract amount. When the defects in services cannot be corrected by reperformance, the Government may-

(1) Require the Contractor to take necessary action to ensure that future performance conforms to contract requirements; and

(2) Reduce the contract price to reflect the reduced value of the services performed.

(f) If the Contractor fails to promptly perform the services again or to take the necessary action to ensure future performance in conformity with contract requirements, the Government may-

(1) By contract or otherwise, perform the services and charge to the Contractor any cost incurred by the Government that is directly related to the performance of such service; or

(2) Terminate the contract for default.

(End of clause)

SECTION F – DELIVERIES OR PERFORMANCE

F.1 Observance of Federal Holidays

Official Holidays New Year’s Day January 1st Martin Luther King’s Birthday 3rd Monday in January Presidents’ Day 3rd Monday in February Memorial Day Last Monday in May Juneteenth June 19th Independence Day July 4th Labor Day 1st Monday in September Columbus Day 2nd Monday in October Veterans’ Day November 11th Thanksgiving Day 4th Thursday in November Christmas Day December 25th Inauguration Day Every fourth year, Washington, DC

No on site services shall be performed, nor shall HHS reimburse a contractor for work performed on Federal legal holidays, holidays set forth by Presidential Executive Order and any other Government closures, including closures for inclement weather, unless otherwise provided for in the terms of the contract. The contractor may not bill for hours not worked.

F.2 Period of Performance

The period of performance shall be a base period of twelve months and four (4) twelve-month option periods. The option periods under this contract may be exercised in accordance with FAR clause 52.217- 9 Option to Extend the Term of the Contract (MAR 2000). In addition, the Government may extend the service for additional 6 months under FAR clause 52.217-8 Option to Extend Services. The period of performance under this contract shall commence with the effective date of the contract.

F.3 Schedule of Deliverables

The contractor shall ensure all products and services delivered under this contract are compliant with HHS Section 508 requirements in accordance with the Health and Human Services Acquisition Regulation (HHSAR). These Section 508 Standards were issued by the United States Access Board (https://www.access-board.gov/) and published in the Federal Register, on January 18, 2017, as the final rule (https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule). The final rule updates the Section 508 Standards along with accessibility guidelines for telecommunication products and equipment covered by section 255 of the Communications Act.

The Section 508 Standards applicable to this contract are:

Section 508 Standards and Guidelines (https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines)

• Web Content Accessibility Guidelines (WCAG) 2.0 o Success Criteria, Level A and AA

• Chapter 3: Functional Performance Criteria (FPC)

• Chapter 4: Hardware (If Applicable) https://www.access-board.gov/ https://www.access-board.gov/ https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines

• Chapter 5: Software

• Chapter 6: Support Documentation and Services

Section 508 requires that all external public facing content and non-public facing official agency communications be accessible. Regardless of format, all digital content or communications materials produced as deliverables under this contract must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities.

The Contractor shall complete and submit the applicable HHS Section 508 Accessibility Compliance Checklist per Section 508 deliverable. The checklist will serve as an artifact declaration of the Section 508 deliverable's compliance. Remediation of any Section 508 deliverables that do not comply with the applicable requirements as set forth below shall be the Contractor's responsibility.

HHS guidance and checklists regarding accessibility of documents can be found at https://www.hhs.gov/web/section-508/accessibility-checklists/index.html.

The HHS Section 508 Product Assessment Template (PAT) that is referenced above in 352.239-73 Electronic Information and Technology Accessibility Notice, Paragraph (c), has been replaced with the Voluntary Product Accessibility Template Version (VPAT) 2.1 or later, and is considered to meet HHS PAT requirement. The new form can be downloaded from https://www.itic.org/policy/accessibility/vpat.

The contractor shall submit deliverables as described in subsequent table to the COR via an email. The format of the deliverables shall be specified by the COR.

Number Item Description Date of Delivery and Frequency*

Corresponding Task

D01

Initial/kick-off meeting minutes

7 business days after the initial/kick- off meeting

1.1 – Attend Initial/Kick- off Meeting

D02 Quarterly COR meeting agenda

7 business days prior to the quarterly COR meeting

1.2 – Attend Quarterly COR Meetings

D03

Quarterly COR meeting minutes

7 business days after the quarterly COR meeting

1.2 – Attend Quarterly COR Meetings

D04 Special COR meeting agenda 5 business days prior to the special COR meeting

1.3 - Attend Special COR Meetings

D05 Special COR meeting minutes

5 business days after the special COR meeting

1.3 - Attend Special COR Meetings

D06 Policy and technical direction process plan

11/28/2022 and as changes are proposed thereafter

1.4 – Establish Policy and Technical Direction of the

SCTOD

D07 Data collection plan 10/31/2022 and as changes are proposed thereafter

2.1 – Collect and Maintain Outcomes Data

D08 Data transmission agreements

30 days prior to enactment of the agreement

2.1 – Collect and Maintain Outcomes Data

D9 Evaluation plan 02/24/2023 and annually 2.2 – Evaluate Data Collection Process and Assess Gaps in Data

D10 Data validation and verification plan

11/28/2022 and annually 2.3 – Develop a Data Validation and Verification Plan https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.itic.org/policy/accessibility/vpat

Corresponding Task

D11 Document describing archiving process

01/25/2023 and annually 2.4 – Implement Process to Maintain Historical Data Sets and Programming Code

D12 D12A Data Dissemination policy and plan, copies of draft data reports.

D12B Master list of published, peer-reviewed articles

D12A-12/28/2022 and annually

D12B- 09/01/2023 and annually

3.1 – Disseminate Data Sets and Summaries to the Public

D13 SAFs package (SAFs, electronic data dictionary, data operations manual)

Quarterly, beginning 12/15/2022

3.2 – Create Standard Analysis Files (SAFs)

D14 Analytic support plan for HRSA requests and draft website content

Within 14 days of request and within six weeks of request respectively

4.1 – Provide Analytic Support to HRSA

D15 Annual study plan 05/01/2023 and annually 5.1 – Report on Study Priorities in the Field of Stem Cell Transplantation and Cellular Therapy

D16 Report on the current state of quality of life and analysis to improve patient late-effects

08/27/2023 and every 2 years 5.2 – Report on the Current State of Quality of Life for Transplant Recipients and Analysis to Improve Patient Late-Effects

D17 Plan for conducting comparisons of treatment options

01/25/2023 5.3 – Compare Treatment Options and Outcomes

D18 Final report on the comparison of treatment options and outcomes

In accordance with the timeline in the plan (D17)

5.3 – Compare Treatment Options and Outcomes

D19 Monthly progress report

10/10/22 and monthly 6.1 – Submit Progress Reports

D20 Quarterly SCTOD report 12/01/22 and quarterly (once a year, final quarterly report should contain a list of function measures)

6.2 – Provide a Quarterly SCTOD Function Report

D21 Proposed outline of the annual statistical report

01/23/2023 and annually 6.3 – Submit Annual Statistical Report on SCTOD Activities

D22 Annual statistical report 02/27/2023 and annually 6.3 – Submit Annual Statistical Report on SCTOD Activities

D23 Methodology and outline for conducting center-specific survival analysis

05/01/2023 and annually until 05/01/2025; bi-annually starting 05/01/2026

6.4 – Develop and Disseminate Transplant Center Survival Rates

D24 Report file 09/01/2023 and annually 6.4 – Develop and Disseminate Transplant

Corresponding Task

Center Survival Rates D25 National center-level summary report 09/01/2023 and annually 6.4 – Develop and

Disseminate Transplant Center Survival Rates

D26 Plan on the cord blood bank reports

11/28/2022 and annually 6.5 – Provide Cord Blood Bank Reports

D27 Transition plan 14 days after the effective date of the contract

7.1 – Submit Transition Plan

F.4. Reporting Requirements and Deliverables

F.4.1. The contractor shall submit the items in quantities and during the time periods indicated above to the following email address:

Division of Transplantation

Healthcare Systems Bureau Health Resources and Services Administration U.S. Department of Health and Human Services 5600 Fishers Lane Rockville, MD 20857

Email: TBD

F.4.2. All deliverable reports shall include a cover page with the following information:

1) Contract number

2) Deliverable item number

3) Deliverable item delivery due date

4) Date of submission

All reports and documents shall have, at a minimum in the document header, the contract number, and the COR’s name. All reports and documents shall have, at a minimum in the document footer, the author in the lower left corner, the page # of total # of pages in the center bottom of the page, and the date and /or version of the document (not the auto date) in the lower right corner.

F.4.3. All deliverables items are to be separate physical entities.

F.4.4. All deliverables are subject to the review and approval of the COR.

F.5. 52.242-15 Stop-Work Order (Aug 1989)

(a) The Contracting Officer may, at any time, by written order to the Contractor, require the Contractor to stop all, or any part, of the work called for by this contract for a period of 90 days after the order is delivered to the Contractor, and for any further period to which the parties may agree. The order shall be specifically identified as a stop-work order issued under this clause. Upon receipt of the order, the Contractor shall immediately comply with its terms and take all reasonable steps to minimize the incurrence of costs allocable to the work covered by the order during the period of work stoppage. Within a period of 90 days after a stop-work is delivered to the Contractor, or within any extension of that period to which the parties shall have agreed, the Contracting Officer shall either-

(1) Cancel the stop-work order; or

(2) Terminate the work covered by the order as provided in the Default, or the Termination for

Convenience of the Government, clause of this contract.

(b) If a stop-work order issued under this clause is canceled or the period of the order or any extension thereof expires, the Contractor shall resume work. The Contracting Officer shall make an equitable adjustment in the delivery schedule or contract price, or both, and the contract shall be modified, in writing, accordingly, if-

(1) The stop-work order results in an increase in the time required for, or in the Contractor’s cost properly allocable to, the performance of any part of this contract; and

(2) The Contractor asserts its right to the adjustment within 30 days after the end of the period of work stoppage; provided, that, if the Contracting Officer decides the facts justify the action, the Contracting Officer may receive and act upon the claim submitted at any time before final payment under this contract.

(c) If a stop-work order is not canceled and the work covered by the order is terminated for the convenience of the Government, the Contracting Officer shall allow reasonable costs resulting from the stop-work order in arriving at the termination settlement.

(d) If a stop-work order is not canceled and the work covered by the order is terminated for default, the Contracting Officer shall allow, by equitable adjustment or otherwise, reasonable costs resulting from the stop-work order.

SECTION G – CONTRACT ADMINISTRATION DATA

G.1. Contracting Officer’s Authority

The Contracting Officer is the only person authorized to make or approve any changes in any of the requirements of this contract, and, notwithstanding any provisions contained elsewhere in this contract, the said authority remains solely in the Contracting Officer. In the event the Contractor makes any changes at the direction of any person other than the Contracting Officer, the change will be considered to have been made without authority and no adjustment will be made in the contract terms and conditions, including price.

G.2. Designation of Contracting Officer Representative (COR)

The person identified below is hereby designated as the Contracting Officer Representative (COR) for this contract. The responsibility of the COR is to ensure that the Government’s technical objectives are met. To this end, the COR will provide necessary information, direction, coordination, etc., within the contractual work description. Issuance of changes which affect the articles, terms, or conditions of this contract will be accomplished through the Contracting Officer who is the only party authorized to bind the Government to contract:

TBD

Division of Transplantation Health Systems Bureau Health Resources and Services Administration U.S. Dept. of Health and Human Services 5600 Fishers Lane Rockville, MD 20857

Phone Number: TBD Email: TBD

G.3. Contracting Officer’s Representative’s Responsibility

Technical Direction – The COR will provide the necessary information, direction, and coordination within the confines of the existing contractual work description in order for the contract to have a successful outcome for the government.

This includes providing technical direction to the Contractor to guide the contract effort in order to accomplish the contractual performance work statement. This may include providing information to the Contractor for assistance in the interpretation of government provided information, specifications or technical portions of the work description, and where required by the contract, review and approval of product deliverables of the Contractor to the Government under the contract. Only the Contracting Officer has the authority to make a formal change to the contract.

G.4. Restrictions on the Contracting Officer’s Representative’s Authority

Direction given by the COR to the Contractor must be within the parameters of the Performance Work Statement as stated in the Contract.

The COR may not issue any direction to the Contractor that:

1. Solicits a proposal, OR

2. Constitutes an assignment of additional work outside the Performance Work Statement of this Contract, OR

3. In any manner causes an increase in the total contract cost or the time required for contract performance, OR

4. Changes any of the express terms, conditions, or specifications of the Contract (i.e., changes in the cost or scope of work, instructions to start or stop work, approval of any actions that will result in additional charges to the government).

Issuance of changes that affect the articles, terms, or conditions of this Contract will be accomplished through the Contracting Officer, who is the only party authorized to bind the Government to contract and the only party who can determine if a direction is within the Performance Work Statement.

G.5. Key Personnel

Pursuant to the Key Personnel clause (HHSAR 352.237-75) referenced in SECTION I of this contract, the following individual(s) is (are) designated as Key Personnel and considered to be essential to the work being performed under this contract:

Title Name

(To be completed at time of award)

Contact information for key personnel:

Name:

Phone:

Email:

The person identified as the ______________ shall direct the necessary work and services toward fulfillment of the contractual requirements. Prior to removing, replacing, or diverting the specified individual(s), the Contractor shall notify the Contracting Officer in writing and reasonably in advance, and shall submit justification (including proposed substitutions) in sufficient detail to permit evaluation of the impact on the contract. No diversion shall be made by the Contractor without the written consent of the Contracting Officer, provided that the Contracting Officer may ratify in writing changes made due to events beyond the control of the Contractor, and such ratification shall constitute the consent of the Contracting Officer required by this clause. Examples of events beyond the control of the Contractor are:

(1) prolonged sickness, (2) termination of employment, and (3) death. Key personnel, with the consent of the Contracting Officer, may be amended from time to time during the course of the contract to either add or delete personnel, as appropriate.

G.6. Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP)

G.6.1. All Invoice submissions for goods and or services delivered to facilitate payments must be made electronically through the U.S. Department of Treasury’s Invoice Processing Platform System (IPP).

G.6.2. 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 the applicable Prompt Payment clause included in the 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.

https://www.ipp.gov/

G.6.3. The Department of Treasury 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.

G.6.4. 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.

G.6.5. 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.

G.6.6. If your company is already registered to use IPP, you will not be required to re-register.

G.6.7. 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.

Additional HRSA Invoice Requirements:

a. The contractor shall submit invoices under this contract once per month or as specified in the payment schedule. For indefinite delivery vehicles, separate invoices must be submitted for each order.

b. Invoices must break-out price/cost by contract line item number (CLIN) as specified in the pricing section of the contract.

c. Invoices must include the Dun & Bradstreet Number (DUNS) of the Contractor.

d. Invoices that include time and materials or labor hours CLINS 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 CLINs must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts.

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

1. 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;

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

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

mailto:ipp.noreply@mail.eroc.twai.gov mailto:IPPCustomerSupport@fiscal.treasury.gov

4. 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;

5. Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

6. Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

7. Fee – amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

G.7. Electronic Funds Transfer

The Contractor shall designate a financial institution for receipt of electronic funds transfer payments and it shall be reported in Systems for Award Management (SAM) and shall be submitted in writing to the finance office set forth in Section G.5.6. All data stored in the CCR and ORCA has been transferred to the new Systems for Award Management (SAM) and can be found at www.sam.gov. Contractors are encouraged to periodically review their file for accuracy and are required to re-reregister before their expiration date, which is the same date as their CCR expiration date. SAM will notify users by e-mail that their file is due to expire beginning 60 days prior to expiration, then 30 days and finally 15 days before expiration. Directions on how to navigate SAM can be found on the site’s Home Page by clicking Help in the navigation bar at the top of the page.

G.8. Evaluation of Contractor’s Performance evaluation of Contractor performance shall be conducted on this contract in Interim and final evaluation of Contractor performance on this contract shall be conducted in accordance with FAR Subpart 42.15, and HHSAR 342.7001(d). Upon contract completion, a final evaluation of the Contractor’s performance shall be completed by the Government; see Section J, Attachment C.

The Government will conduct an evaluation of Contractor’s performance based on the completion of the tasks stated in the SOW. HRSA documents contractor performance using the Contractor Performance Assessment Rating System (CPARS) (www.cpars.gov). The evaluation shall be conducted by the COR and be comprised of an evaluation of contractor performance completed by the Contractor and Federal staff, and a review of progress reports and financial reports (deliverables).

http://www.sam.gov/

SECTION H – SPECIAL CONTRACT REQUIREMENTS

H.1. Food

Food (including but not limited to meals, light refreshments, and beverages) is not to be provided and is an unallowable cost.

H.2. Equipment

The Contractor shall not use federal funding available through this contract for costs incurred for services or equipment which are reimbursable as part of another government contract. The federal funding available through this contract shall not be used to reimburse the contractor for the purchase of computer hardware and/or software without prior Contracting Officer approval.

H.3. Confidentiality Agreement Requirement

The Contractor shall implement a confidentiality agreement related to all data provided by the Government staff. All Contractor staff that work with the Federal Government and are provided information and access to databases shall sign such an agreement and a copy of the signed agreement for each relevant staff member shall be submitted to the COR prior to receipt of relevant documents.

H.4. Travel Reimbursement

Any travel reimbursement under this contract shall be performed in accordance with Federal Travel Regulations.

H.5. Prohibition against Personal Services

The Contractor shall not perform personal services as defined under FAR 2.101 under this contract.

Contractor personnel are employees of the Contractor or its subcontractors and are under the administrative control and supervision of the Contractor. A Contractor supervisor must give all individual Contractor employee assignments and daily work direction. The Government will not supervise or direct Contractor employees in the performance of their assignments. If at any time the Contractor believes that any Government action or communication has been given that would create a personal service relationship between the Government and any Contractor employee, the contractor shall promptly notify the Contracting Officer of this communication or action. The Contractor shall not perform any inherently governmental functions under this contract. No Contractor employee shall represent or give the appearance that he/she is a Government employee, agent or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government. The Contractor is responsible for ensuring that all employees assigned to this contract understand and are committed to following these requirements.

H.6. Conflict of Interest

1. Conflict of Interest (COI):

The Contractor shall have procedures in place to monitor and disclose all Organizational and Personal Conflicts of Interest throughout the life of the contract.

2. COI information shall be submitted as follows:

a. Initial Submission of COI Information: The Contractor shall submit Conflict of Interest information identified in the performance of the contract.

b. Mitigation/Resolution: The CO determines whether a COI has been identified and whether the actual, potential or apparent COI has been mitigated/resolved to the

Government’s satisfaction. The Contractor's approved COI Mitigation/Resolution plan shall be incorporated into the contract.

c. In cases whereby a COI cannot be, or has not been, mitigated to the CO’s satisfaction, the CO may take the following action including, but not limited to:

i. Request a waiver in accordance with FAR 9.503 Waiver, from the Head of the Contracting Activity; or

ii. Make changes to the requirements of the contract; or

iii. Terminate the contract.

3. COI disclosure during contract performance: COI Disclosure Revisions shall be submitted to the

CO.

4. Subcontractor Flow-Down Clause: The prime Contractor is responsible for avoiding, neutralizing and mitigating all actual, potential, or apparent COIs of its Subcontractors, in accordance with this clause. Therefore, the prime Contractor shall flow-down applicable clauses of this contract in all subcontracts. For Subcontractors, wherever the term “Contractor” is used, insert “Subcontractor.”

SECTION I – CONTRACT CLAUSES

I.1 Federal Acquisition Regulation (FAR) (48 CFR Chapter 1) Contract Clauses

FAR 52.252-2 Clauses Incorporated by Reference (FEB 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at www.acquisition.gov/far.

CLAUSE NO. TITLE DATE

52.202-1 Definitions. Nov 2013 52.203-3 Gratuities. Apr 1984 52.203-5 Covenant Against Contingent Fees. May 2014 52.203-6 Restrictions on Subcontractor Sales to the Government. Jun 2020 52.203-6 Alternate I. Jun 2020 52.203-7 Anti-Kickback Procedures. Jun 2020 52.203-8 Cancellation, Rescission, and Recovery of Funds for Illegal or

Improper Activity.

May 2014

52.203-10 Price or Fee Adjustment for Illegal or Improper Activity. May 2014 52.203-12 Limitation on Payments to Influence Certain Federal Transactions. Jun 2020 52.203-13 Contractor Code of Business Ethics and Conduct. Nov 2021 52.203-14 Display of Hotline Poster(s). Nov 2021 52.203-15 Whistleblower Protections Under the American Recovery and

Reinvestment Act of 2009.

June 2010

52.203-16 Preventing Personal Conflicts of Interest. Jun 2020 52.203-17 Contractor Employee Whistleblower Rights and Requirement To

Inform Employees of Whistleblower Rights.

Jun 2020

52.203-19

52.204-3

Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements.

Taxpayer Identification.

Jan 2017

Oct 1998

52.204-4

52.204-5 52.204-7

Printed or Copied Double-Sided on Postconsumer Fiber Content Paper.

Women-Owned Business (Other Than Small Business).

System for Award Management.

May 2011 Oct 2014 Oct 2018 Oct 2018

52.204-9 Personal Identity Verification of Contractor Personnel. Jan 2011 52.204-10 Reporting Executive Compensation and First-Tier Subcontract

Awards.

Jun 2020

52.204-12 Unique Entity Identifier Maintenance. Oct 2016 52.204-13 System for Award Management Maintenance. Oct 2018 52.204-14 Service Contract Reporting Requirements. Oct 2016 52.204-18 Commercial and Government Entity Code Maintenance. Aug 2020 52.204-19 Incorporation by Reference of Representations and Certifications. Dec 2014 52.204-21 52.204-22

Basic Safeguarding of Covered Contractor Information Systems.

Alternative Line Item Proposal.

Nov 2021 Jan 2017

52.204-23

52.204-24

Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities.

Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment.

Nov 2021 Nov 2021

Nov 2021

52.204-25

20.204-26

Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

Covered Telecommunications Equipment or Services-Representation

Nov 2021

Oct 2020 http://www.acquisition.gov/far

52.207-3 52.209-2

Right of First Refusal of Employment.

Prohibition on Contracting with Inverted Domestic Corporations- Representation.

May 2006 Nov 2015

52.209-6

52.209-7

Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment.

Information Regarding Responsibility Matters

Nov 2021

Oct 2018

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

Oct 2018

52.209-10 52.209-11

Prohibition on Contracting with Inverted Domestic Corporations.

Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law.

Nov 2015 Feb 2016

52.210-1 Market Research. Nov 2021 52.215-2 Audit and Records – Negotiations. Jun 2020 52.215-8 Order of Precedence-Uniform Contract Format. Oct 1997 52.215-10 Price Reduction for Defective Certified Cost or Pricing Data. Aug 2011 52.215-11 Price Reduction for Defective Certified Cost or Pricing Data-

Modifications.

Jun 2020

52.215-12 Subcontractor Certified Cost or Pricing Data. Jun 2020 52.215-13 Subcontractor Certified Cost or Pricing Data-Modifications. Jun 2020 52.215-18 Reversion or Adjustment of Plans for Postretirement Benefits (PRB)

Other Than Pensions.

Jul 2005

52.215-19 Notification of Ownership Changes. Oct 1997 52.215-23 Limitations on Pass-Through Charges. Jun 2020 52.217-6 Option for Increased Quantity. Mar 1989 52.217-8 Option to Extend Services. Mar 1989 52.219-8 Utilization of Small Business Concerns. Oct 2018 52.219-9 Small Business Subcontracting Plan. Mar 2020 52.222-3 Convict Labor. Jun 2003 52.222-21 Prohibition of Segregated Facilities. Apr 2015 52.222-26 Equal Opportunity. Sep 2016 52.222-40 Notification of Employee Rights Under the National Labor Relations

Act.

Dec 2010

52.222-41 Service Contract Labor Standards. Aug 2018 52.222-44 Fair Labor Standards Act and Service Contract Labor Standards-

Price Adjustment.

May 2014

52.222-50 Combating Trafficking in Persons. Jan 2019 52.222-54 Employment Eligibility Verification. Oct 2015 52.222-55 Minimum Wages for Contractor Workers Under Executive Order

14026.

Dec 2015

52.222-62 Paid Sick Leave Under Executive Order 13706. Jan 2017 52.223-6 Drug-Free Workplace. May 2001 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While

Driving.

Jun 2020

52.224-1 Privacy Act Notification. Apr 1984 52.224-2 Privacy Act. Apr 1984 52.224-3 Privacy Training. Jan 2017 52.224-13 Restrictions on Certain Foreign Purchases. Jun 2008 52.227-14 Rights in Data-General. May 2014 52.232-1 Payments. Apr 1984 52.232-39 Unenforceability of Unauthorized Obligations. Jun 2013 52.233-1 Disputes. May 2014 52.233-3 Protest after Award. Aug 1996

52.233-4 Applicable Law for Breach of Contract Claim. Oct 2004 52.244-6 Subcontracts for Commercial Products and Commercial Services. Jun 2020 52.245-1 Government Property. Jan 2017 52.245-9 Use and Changes. Apr 2012 52.246-25 Limitation of Liability-Services Feb 1997 52.248-1 Value Engineering. Jun 2020 52.250-1 Indemnification Under Public Law85-804. Apr 1984 52.253-1 Computer Generated Forms. Jan 1991

I.2. Options

I.2.1. FAR 52.217-7, Option for Increased Quantity--Separately Priced Line Item (MAR 1989) The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor within one day. Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree.

I.2.2. FAR 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 within 30 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension.

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

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

I.3. Protest

I.3.1. FAR 52.233-2 Service of Protest Service of Protest (Sept 2006)

(a) Protests, as defined in section 33.101 of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the Government Accountability Office (GAO), shall be served on the Contracting Officer by obtaining written and dated acknowledgment of receipt from:

Jimmy Hupalar, Contracting Officer

Office of Acquisition Management & Policy Health Resources & Services Administration 5600 Fishers Lane Rockville, MD 20857 Office: 301-443-1166

(b) The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO.

https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%2033_1.html#wp1088681

I.4. Changes

I.4.1. FAR 52.243-7 Notification of Changes (Jan 2017)

(a) Definitions. “Contracting Officer,” as used in this clause, does not include any representative of the Contracting Officer.

“Specifically Authorized Representative (SAR),” as used in this clause, means any person the Contracting Officer has so designated by written notice (a copy of which shall be provided to the Contractor) which shall refer to this paragraph and shall be issued to the designated representative before the SAR exercises such authority.

(b) Notice. The primary purpose of this clause is to obtain prompt reporting of Government conduct that the Contractor considers to constitute a change to this contract. Except for changes identified as such in writing and signed by the Contracting Officer, the Contractor shall notify the Administrative Contracting Officer in writing promptly, within five calendar days from the date that the Contractor identifies any Government conduct (including actions, inactions, and written or oral communications) that the Contractor regards as a change to the contract terms and conditions. On the basis of the most accurate information available to the Contractor, the notice shall state-

(1) The date, nature, and circumstances of the conduct regarded as a change;

(2) The name, function, and activity of each Government individual and Contractor official or employee involved in or knowledgeable about such conduct;

(3) The identification of any documents and the substance of any oral communication involved in such conduct;

(4) In the instance of alleged acceleration of scheduled performance or delivery, the basis upon which it arose;

(5) The particular elements of contract performance for which the Contractor may seek an equitable adjustment under this clause, including-

(i) What line items have been or may be affected by the alleged change;

(ii) What labor or materials or both have been or may be added, deleted, or wasted by the alleged change;

(iii) To the extent practicable, what delay and disruption in the manner and sequence of performance and effect on continued performance have been or may be caused by the alleged change;

(iv) What adjustments to contract price, delivery schedule, and other provisions affected by the alleged change are estimated; and

(6) The Contractor’s estimate of the time by which the Government must respond to the Contractor’s notice to minimize cost, delay or disruption of performance.

(c) Continued performance. Following submission of the notice required by paragraph (b) of this clause, the Contractor shall diligently continue performance of this contract to the maximum extent possible in accordance with its terms and conditions as construed by the Contractor, unless the notice reports a direction of the Contracting Officer or a communication from a SAR of the Contracting Officer, in either of which events the Contractor shall continue performance; provided, however, that if the Contractor regards the direction or communication as a change as described in paragraph (b) of this clause, notice shall be given in the manner provided. All directions, communications, interpretations, orders and similar actions of the SAR shall be reduced to writing promptly and copies furnished to the Contractor and to the Contracting Officer. The Contracting Officer shall promptly countermand any action which exceeds the authority of the SAR.

(d) Government response. The Contracting Officer shall promptly, within five calendar days after receipt of notice, respond to the notice in writing. In responding, the Contracting Officer shall either-

(1) Confirm that the conduct of which the Contractor gave notice constitutes a change and when necessary direct the mode of further performance;

(2) Countermand any communication regarded as a change;

(3) Deny that the conduct of which the Contractor gave notice constitutes a change and when necessary direct the mode of further performance; or

(4) In the event the Contractor’s notice information is inadequate to make a…