Amendment_4_reposts_Amend_2_with_attachments_0004.pdf

OMB No.: 0990-0115

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

PAGE

OF PAGES

2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE DATE

1/12/2023

4. REQUISITION/PURCHASE

REQ. NO.

5. PROJECT NO. (if applicable)

6. ISSUED BY CODE

7. ADMINISTERED BY (If other than Item 5) CODE

National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health and Human Development Contracts Management Branch

6710B Rockledge Drive

BETHESDA MD 20892

8. NAME AND ADDRESS OF CONTRACTOR (No., street, city, county, State and ZIP Code)

TO ALL POTENTIAL OFFERORS

9A. AMENDMENT OF SOLICITATION

NO.

RFP 75N94022R00003 X

9B. DATED (SEE ITEM 11)

12/12/2022

10A. MODIFICATION OF

CONTRACT/ORDER NO.

CODE

FACILITY CODE

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

x The above numbered solicitation is amended as set forth in item 14. The hour and date specified for receipt of Offers is extended.

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing Items 8 and 15, and returning __1___ copy of the amendment in your business proposal; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (if required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO FAR 52.243-2. THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT

ORDER NO. IN ITEM 10A.

B.THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b) and Contract ARTICLE B.4.

C.THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D.OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor __ is not, X is required to sign this document and return 1 copy in your business proposal to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

PURPOSE: To amend RFP 75N94022R00003, entitled, “International and Domestic Pediatric and Maternal HIV and Other High Priority Infectious Diseases Data Coordinating Center.” This amendment also answers questions received regarding the

RFP.

DUE DATE: is extended until February 22, 2023, 4:00 PM Local Time (Eastern Standard Time (EST) (Changed).

Except as provided herein, all terms and conditions of the document referenced in item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

16A. NAME AND TITLE OF CONTRACTING OFFICER

Elizabeth Osinski

NICHD Contracts Management Branch, NIH

15B. CONTRACTOR/OFFEROR

BY ______________________________________________

(Signature of person authorized to sign)

15C. DATE SIGNED

16B. UNITED STATES OF AMERICA

BY ________________________________________

(Signature of Contracting Officer)

16C.DATE

SIGNED

RFP-NIH-NICHD-75N94022R00003

AMENDMENT NO.: 002 CONTINUATION PAGE Page 2 of 7

A. As a result of this amendment, RFP No. 75N94022R00003, is revised as follows:

1. Attachment 5, Task Order 2, Statement of Work and Reporting Requirements/Deliverables, Page 181of the RFP, is revised to delete the requirement for Clinical Site Monitoring Reports.

2. Attachment 6, Task Order 3 Statement of Work and Reporting Requirements/Deliverables, page 186 of the RFP, is revised to delete the requirement for Clinical Site Monitoring Reports.

3. Section I – Contract Clauses, FAR clauses in Articles I.1. (page 69), the lists of these FAR clauses are included as an attachment to this Amendment.

4. Section J, Attachment 9-Additional Proposal Information and Instructions, is replaced in its entirety with the attached Revised Attachment 9 dated 1-12-2023. This revised attachment provides more uniform cost assumptions and more information on preparation of proposals.

5. Section J, Attachment 8 – NICHD IMPAACT Network Clinical Sites, is replaced in its entirety with Attachment 8 dated 1-12-2023 attached as part of this amendment. (The list of business contacts has been added to the list of clinical sites to assist prospective offerors in obtaining letters of commitment from the selected NICHD clinical sites).

6. Section J, Attachment 10 – Most Recent Draft Schedules of Evaluation, has been added to the RFP for informational purposes to the offerors.

7. Section J, Attachment 11 – Lists of General FAR Clauses are added to the RFP.

B. This Amendment provides answers to questions received regarding this RFP. Please note that individual questions may have been combined or reworded. The responses are provided for information only as guidance to potential offerors and do not supersede any terms of the RFP, and do not revise or become part of this RFP.

Solicitation Section Reference Question Attachment 5; Task Order 2 Statement of Work and Reporting Requirements/Deliverables; page 5 (page 181 of 196); Technical Reporting Requirements and Deliverables Table

1.Since Clinical Site Monitoring is not included in the Task Order 2 SOW and Clinical Site Monitoring for the IMPAACT 2040 study will be conducted under Task Order 1, please confirm that “Site Monitoring Reports” should be removed from the Task Order 2 Deliverables table.

ANSWER: YES, they should be removed from the Task Order 2 deliverables. See amended Section A of this amendment. The Site Monitoring Reports are deliverables in Task 1.

Attachment 6; Task 3 Statement of Work and Reporting Requirements/Deliverables; page 5 (page 186 of 196); Technical

2.Since Clinical Site Monitoring is not included in the Task Order 3 SOW and Clinical Site Monitoring for the IMPAACT 2024 study will be conducted under Task Order 1, please confirm that “Site Monitoring Reports”

AMENDMENT NO.: 002 CONTINUATION PAGE Page 3 of 7

Solicitation Section Reference Question Reporting Requirements and Deliverables Table should be removed from the Task Order 3 Deliverables table.

ANSWER: YES, they should be removed from the Task Order 3 deliverables. See amended Section A of this amendment. The Site Monitoring Reports are deliverables in Task 1.

ARTICLE H.35.1. Information Security and/or Physical Access Security Article H.35.1.A.b.iv (page 41)

3. Article H.35.1.A.b.iv states that the contractor must “Report any discovered or unanticipated threats or hazards by either the agency or contractor, or if existing safeguards have ceased to function immediately after discovery, within one (1) hour or less.” Please confirm if the Government is willing to modify the one (1) hour requirement to a 24-hour requirement.

o See also H.35.1.A.4.b.iii (p.44) “Incident Response” and H.35.4.F.a, “Incident Reporting” under Cloud Services (p.56), and L.17.I (p.105) and L.17.N (p.107-8), which also includes a requirement for reporting within 1 hour of discovery

ANSWER: The reporting guideline must remain. It is an NIH requirement.

ARTICLE H.35.1. Information Security and/or Physical Access Security Article H.35.1.A.f (p.40)

4.Article H.35.1.A.f requires the contractor to “Protect all government information that is or may be sensitive by securing it with a solution that is validated with current FIPS 140 validation certificate from the NIST CMVP.”

Would the Government consider allowing contractors to use industry-equivalent validation standards in lieu of

FIPS-140?

o See also H.35.1.A.l (p.43), H.35.1.2.4.b (p.44), H.35.1.e.i (p.51); H.35.4.F (p.56), H.35.4.H (p.

58), L.2.17.G (p.103), where FIPS-140 is referenced.

ANSWER: A Commensurate solution as outlined by the NIST requirement can be used.

ARTICLE H.35.1. Information Security and/or Physical Access Security Article H.35.1.4.b.iv (p.44)

5. Article H.35.1.4.b.iv states that the contractor should provide full access to the government during incident response, “This may also involve physical access to contractor facilities during a breach/incident investigation within an hour of discovery. ” Please confirm if the Government is willing to modify the one

(1) hour requirement to a 24-hour requirement.

o See also L.2.17.N.5 (p.108) “Incident Response” which also includes a requirement for allowing access within 1 hour of incident discovery.

ANSWER: The reporting guideline must remain. It is an NIH requirement.

AMENDMENT NO.: 002 CONTINUATION PAGE Page 4 of 7

Solicitation Section Reference Question ARTICLE H.35.3. Government Information Processed on GOCO Or COCO Systems Article H.35.3.1.e.ii (p. 51)

6. Article H.35.3.1.e.ii states that the contractor must “Configure laptops and desktops in accordance with the latest applicable United States Government Configuration Baseline (USGCB), and HHS Minimum Security Configuration Standards.” Would the Government consider allowing contractors to use industry-equivalent standards in lieu of USGCB?

o See also L.2.17.G.2 (p.104), which includes the same reference to USGCB.

ANSWER: The NIH HHS Minimum Security Configuration Standards are based on modified CIS benchmarks. CIS benchmarks can be used.

ARTICLE H.35.3. Government Information Processed on GOCO Or COCO Systems Article H.35.3.1.e.v (p. 51)

7. The first bullet point under Article H.35.3.1.e.v requires the contractor to “Configur[e] its systems to allow for periodic HHS vulnerability and security configuration assessment scanning.” Please confirm if the Government is willing to accept modification of this requirement to allow the Contractor to conduct/provide scans without requiring granting external access for vulnerability assessment/scanning to HHS?

o Article C.2.b.K.i (p.13) also requires the contractor to “afford the Government access to the Contractor's facilities, installations, operations, documentation, information systems, and personnel used in performance of this contract to the extent required to carry out a program of security assessment ( to include vulnerability testing).”

ANSWER: This requirement is applied based on the Contract requirements and IT implementation.

SECTION I - CONTRACT

CLAUSES

FAR clauses in Articles I.1 (p.69)

8. Section I excludes the listing of applicable FAR clauses in Articles I.1. Can the Government please provide the listing of FAR clauses for contract review prior to proposal submission?

ANSWER: YES, these clause lists will be included in the RFP as Attachment 11. See Section A above.

Attachment 9 (pages 4-5) Task Order 2 and Task Order 3

9. Please provide uniform cost assumptions that would cover the costs for sites for Task Orders 2 and 3 including FTEs, lab supplies, office supplies, shipping, travel, equipment at foreign sites (as applicable), and other direct costs to use for budgeting purposes for each individual cost-reimbursement site subcontract (e.g., Task Order 2: Total annual cost placeholder for each site in each of the 3 years; Task Order 3: Total annual cost placeholder for each site in each of the 4 years).

10. ANSWER: Task Order 2 (Protocol 2040) will be fully funded for the entire period of performance and

AMENDMENT NO.: 002 CONTINUATION PAGE Page 5 of 7

Solicitation Section Reference Question the uniform assumption for the entire period of performance for SUBCONTRACTING with the clinical sites is estimated at $900,000.

Task Order 3 (Protocol 2024) will be fully funded and the uniform assumption for the entire period of performance for SUBCONTRACTING with the clinical sites is estimated at $2,000,000.

Please refer to amended language in Revised Attachment 9 included in this amendment for these uniform assumptions. The labor for management of the subcontracts can either be in your proposal under Task Order 1 or proposed in Task Orders 2 and 3. If the offeror elects to place the management personnel under Task Orders 2 and 3 and not Task Order 1, please reduce the Estimated Effort for Task Order 1 in Revised Attachment 9 by the amount of labor proposed for management of Task Orders 2 or 3 in the Task Order 2 and 3 cost proposal. See Revised Attachment 9 for more details.

Attachment 5 – Task 2, section g, (page 179) and Attachment 6 – Task 3, section g, (page 184)

Please provide the actual Schedule of Events for the IMPAACT 2024 and IMPAACT 2040 protocols.

ANSWER: The current status of IMPAACT’s 2024 and 2040 is “in development.” The most recent draft protocol schedules of evaluation are included as Attachment 10 and may be subject to change.

4. Human Subjects (page 112) Please confirm the “SEPARATE FILE of the Technical Proposal entitled, ‘HUMAN SUBJECTS’ referenced on Page 112 of the RFP is exempt from the Technical Proposal page limits, in accordance with Attachment 1.

II. B. (Table on page 2 of 3).

ANSWER: YES, confirmed. Amendment 1 to the RFP exempted this HUMAN SUBJECTS file from the Technical Proposal page limits.

b. Technical Proposal Instructions, 1.b Personnel (page 111) “Describe the experience and qualifications of personnel who will be assigned for direct work on this program….”

Our understanding is that qualified sites have been identified for Task Orders 2 and 3 and as such, local site staff are already identified and hired. Please confirm the following:

• Offerors do not need to contact the sites

• Offerors do not need to propose specific personnel or positions from those sites

• Offerors do not need to provide letters of commitment from the sites for Task Orders 2 and 3 ANSWER: The sites for Task Orders 2 and 3 are identified on the IMPAACT Website. Offerors must contact the sites to request letters of commitment from NICHD sites identified on the IMPAACT

AMENDMENT NO.: 002 CONTINUATION PAGE Page 6 of 7

Solicitation Section Reference Question website (access via URLs below) as selected to conduct the IMPAACT 2024 and IMPAACT 2040 protocols. NICHD sites are identified by CRS IDs in the “5xxx” format.

https://www.impaactnetwork.org/studies/impaact2024 https://www.impaactnetwork.org/studies/impaact2040

Offerors do not need to propose specific personnel or positions from those sites. Offerors shall provide letters of commitment from NICHD sites that have been selected by IMPAACT for Task Orders 2 and 3.

The business and technical contacts for the sites are in the Revised Attachment 8 in this amendment.

Uniform Cost Assumptions for subcontracting for Task Orders 2 and 3 subcontract clinical research site totals are provided in this amendment in the Revised Attachment 9 of the RFP.

Attachment 6 – Task 3 Statement of Work, section 1b, (page 183)

Attachment 6 – Task Order 3 Statement of Work, section 1b states, “Up to 132 participants”; however, on the IMPAACT website, IMPAACT Protocols Snapshot, the IMPAACT 2024 protocol reflects an accrual of 80 subjects. Please confirm if these 80 subjects are those intended to complete the project and hence there is an expected 52 subjects randomized that will not complete the study (52/132 = 40% DO rate).

ANSWER: Note that current status of IMPAACT 2040 and 2024 protocols is “in development” and therefore schedules of evaluation are DRAFT and subject to change. More information about the protocols is available at the links below.

https://www.impaactnetwork.org/studies/impaact-study-snapshots https://www.impaactnetwork.org/studies/impaact2040 https://www.impaactnetwork.org/studies/impaact2024 Please use the value of “up to 132 participants” for IMPAACT 2024 accrual listed in the solicitation. The value of 80 that is included in the IMPAACT “Study Snapshot” online document refers to the minimum number of evaluable participants.

Task Order #2 - collection of pharmacokinetics

Please confirm if the offeror should include PK analysis in the budget and if so, please advise how many PK samples are expected.

ANSWER: PK sample analysis will be performed by IMPAACT specialty pharmacology laboratories. The cost of that laboratory analysis should not be included https://www.impaactnetwork.org/studies/impaact2024 https://www.impaactnetwork.org/studies/impaact2040 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fstudies%2Fimpaact-study-snapshots&data=05%7C01%7Cosinskie%40mail.nih.gov%7C17869daad4f443d9b3a208daf32c071f%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638089667841041000%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=Uz3Dz8uv6HoMR892XXHSqpIpGEGtQ6qk29VSpd6kj10%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fstudies%2Fimpaact-study-snapshots&data=05%7C01%7Cosinskie%40mail.nih.gov%7C17869daad4f443d9b3a208daf32c071f%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638089667841041000%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=Uz3Dz8uv6HoMR892XXHSqpIpGEGtQ6qk29VSpd6kj10%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fstudies%2Fimpaact2040&data=05%7C01%7Cosinskie%40mail.nih.gov%7C17869daad4f443d9b3a208daf32c071f%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638089667841041000%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=HrBrzYWuxZNS4X5Sn1Yn167M1K8xG%2FA5warkOCqTBu8%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fstudies%2Fimpaact2024&data=05%7C01%7Cosinskie%40mail.nih.gov%7C17869daad4f443d9b3a208daf32c071f%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638089667841041000%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=ChpUX4C8a3QUJYrc%2Bb9pgKk%2F0gaMXm96MgubuHhaYvo%3D&reserved=0

AMENDMENT NO.: 002 CONTINUATION PAGE Page 7 of 7

Solicitation Section Reference Question in the budget for Task 2. Those costs are included in the uniform assumption for subcontracting in the Revised Attachment 9 of this RFP. Required costs include those associated with sample collection, processing, transport, shipping, and storage and these costs are included in the uniform assumption for subcontracting in the Revised Attachment 9.

Attachment 9, section c, (page 194) Attachment 9, section c states, “Under Task Order 1, the Contractor may occasionally be asked by NICHD to process specialized laboratory assays that are not conducted by the IMPAACT Core Laboratories.” Can you please provide the offeror with any details you may have available regarding what these specialized laboratory assays may be and the volume expected so that we may know whether to budget for a central lab, separate from the IMPAACT UCLA central lab?

ANSWER: Specialized laboratory assays may include laboratory developed and/or research-use-only virology, immunology, pharmacology, and/or other laboratory methods that will be specified in future task orders and for which anticipated test volume and cost will be incorporated into budgets associated with those future task orders. Budgeting for central laboratory is not required although existing relationships with specialty laboratories may be advantageous and should be described in your proposal.

Attachment 8 Revised 1-12-23

- NICHD IMPAACT Network Clinical Sites

NICHD Network Sites - Domestic - Attachment 17

Site Name City State Site# Principal Investigator (PI) PI Email Address Contract Contact Contract Email Address

Jacobi Medical Center Bronx Bronx NY 5013 Andrew Wiznia andrew.wiznia@nychhc.org Raven Dwyer dwyerr1@nychhc.org Emory University School of Medicine Atlanta GA 5030 Andres Camacho-Gonzalez acamak2@emory.edu Alicia Laake alicia.laake@emory.edu SUNY Stony Brook Stony Brook NY 5040 Sharon Nachman Sharon.Nachman@stonybrookmedicine.edu Erin Infanzon Erin.infanzon@stonybrookmedicine.edu University of Southern California LA Los Angeles CA 5048 Andrea Kovacs akovacs@usc.edu Dragana Davidovic ddavidov@usc.edu University of Florida Jacksonville Jacksonville FL 5051 Mobeen Rathore mobeen.rathore@jax.ufl.edu Tyler Pringle Tyler.Pringle@jax.ufl.edu University of Colorado Denver Denver CO 5052 Myron Levin Myron.levin@ucdenver.edu Alicia Katai Alisa.Katai@childrenscolorado.org Children's Diagnostic & Treatment Center, Inc. Ft. Lauderdale FL 5055 Lisa-Gaye Robinson apuga@browardhealth.org Amy Inman ainman@browardhealth.org Rush University Cook County Hospital Chicago Chicago IL 5083 Mariam Aziz mariam_aziz@rush.edu Marina Vracar-Grabar Marina_Vracar-Grabar@rush.edu John Hopkins University Baltimore Baltimore MD 5092 Allison Agwu ageorg10@jhmi.edu Velma Pack Vpack1@jhmi.edu David Geffen School of Medicine at UCLA Los Angeles CA 5112 Jaime Deville jdeville@mednet.ucla.edu Michael Maple MMapel@mednet.ucla.edu Bronx-Lebanon Hospital Bronx NY 5114 Murli Purswani mpurswan@bronxleb.org Diane Strom dstrom@bronxleb.org University of Miami Miami FL 5127 Charles Mitchell cmitchel@med.miami.edu Grace Alvarez Galvarez2@miami.edu Texas Children's Hospital Houston TX 5128 Mary Paul mpaul@bcm.edu Diana Holbrook Diana.holbrook@bcm.edu

University of Puerto Rico

NICHD Network Sites - International

San Juan PR 5129 Irma Febo-Rodriguez irma.febo2@upr.edu Nestor Colon Nestor.colon@upr.edu

Site Name City Country Site# Principal Investigator (PI) PI Email Address Contract Contact Contract Email Address Insti. Of Pediatrics Fed University Rio de Janeiro Brazil 5071 Ricardo Oliveira rh_oliveira@yahoo.com.br Eduardo Gonçalves eduardo@fujb.ufrj.br Hospital dos Servidores Rio de Janeiro Brazil 5072 Esau Joao esaujoao@gmail.com Jose Carlos josecarlos@diphse.com.br SOM Federal University Minas Gerais Brazil Minas Geraus Brazil 5073 Jorge Pinto jpinto@medicina.ufmg.br Jorge Pinto jpinto@medicina.ufmg.br Univ. of Sao Paulo Brazil Sao Paulo Brazil 5074 Marisa Mussi-Pinhata mmmpinha@fmrp.usp.br Marisa Mussi-Pinhata mmmpinha@fmrp.usp.br Hospital Geral De Nova Iguacu Brazil Rio de Janeiro Brazil 5097 Jose Pilotto jhpilotto@gmail.com Luiz Moreira 78lmoreira@gmail.com Siriraj Hospital, Dept. of Pediatrics-Mahidol University

Bangkok Thailand 5115 Kulkkanya Chokephaibulkit kulkanya.cho@mahidol.ac.th Watcharee Lermankul watchareeped@gmail.com

PHPT Chiangrai Prachanukroh Hospital Chiang Rai Thailand 5116 Gonzague Jourdain gonzague.jourdain@phpt.org Nitima Chaiboonruang nitima.chaiboonruang@phpt.org

KCMC Kilmanjaro Christian Medical Center Moshi Tanzania 5118 Blandina Theophil Mmbaga b.mmbaga@kcri.ac.tz Frank Michael romeomutta@gmail.com

Kericho (KEMRI-Walter Reed) Kericho Kenya 5121 Frederick Sawe Fredrick.sawe@usamru-k.org Karen Davis kdavis@hjf.org

MU-JHU Research Collaboration Kampala Uganda 5126 Clemensia Nakabiito cnakabiito@mujhu.org Airene Profeta Dasal apdasal@mujhu.org mailto:andrew.wiznia@nychhc.org mailto:dwyerr1@nychhc.org mailto:acamak2@emory.edu mailto:akovacs@usc.edu mailto:mobeen.rathore@jax.ufl.edu mailto:Myron.levin@ucdenver.edu mailto:apuga@browardhealth.org mailto:mariam_aziz@rush.edu mailto:Marina_Vracar-Grabar@rush.edu mailto:ageorg10@jhmi.edu mailto:jdeville@mednet.ucla.edu mailto:mpurswan@bronxleb.org mailto:b.mmbaga@kcri.ac.tz

ATTACHMENT 9

ADDITIONAL PROPOSAL INFORMATION AND INSTRUCTIONS as Revised 1-12-

2023 (Replaces original Attachment 9)

In addition to the proposal instructions, conditions, and notices to offerors provided in Section L of the Request for Proposals, the following additional information and instructions are provided herein. It is considered essential that all potential offerors review this document in its entirety.

Task Order 1: “Support Services for AIDS HIV Clinical Trial Networks”

A. Estimate of Effort

To assist in the preparation of the Task Order 1 proposal we are providing below the Government’s estimated annual effort for the Base Period and the six (6) Option Periods. This information is furnished for guidance purposes only and is not to be considered restrictive. THE LEVEL of EFFORT for the management of Tasks 2 and 3 and for managing future HIV Task Orders has been included in the level of effort estimates below. If an offeror wishes to include the labor for the management of Task 2 in Task 2 cost proposal and the management of Task 3 in the Task 3 cost proposal, then the offeror should subtract that effort from the estimates below when it proposes on Task 1.

Labor Category

Annual Effort Year 1

Annual Effort Year 2

Annual Effort Years 3 to 7

Principal Investigator 20% 30% 44%

Project Administrator 40% 60% 88%

Contract Administrator(s) 70% 90% 100%

Project Director 15% 25% 30%

Project Manager(s) 70% 90% 100%

Project Assistant(s) 50% 70% 90%

Clinical Research Assoc (CRAs) 200% 300% 500%

Regulatory Affairs Director 5% 10% 15%

Regulatory Affairs Assistant 20% 35% 50%

Data Quality Manager 5% 8% 10%

Clinical Data Manager 20% 30% 45%

Database Administrator 10% 12% 15%

Analytic Programmer 20% 30% 40%

Data Research Associates 25% 40% 50%

Data Coding/Keying/Editing 40% 60% 80%

Sr. Systems Analyst/Programmer(s) 5% 8% 10%

Clinical Laboratory Specialist 60% 80% 100%

Pharmacist 10% 15% 20%

QC-CRAs (Domestic) 5% 10% 10%

QC-CRAs (International) 15% 20% 25%

Analytic Programming Manager 2% 2% 2%

Systems Analyst/Programmer 3% 5% 10%

Supervisory-Data Analysis/ Epidemiologist/Biostatistician

2%

4% 5%

Data Analysis/ Epidemiologist/Biostatistician

20%

40% 50%

Shipping Coordinator 5% 10% 12%

Website Specialist 5% 5% 5%

Secretarial/Administrative Support 80% 100% 130%

8.22 FTEs

Annually

11.89 FTEs

Annually

16.36 - FTEs Annually

During Year 1 (Base Period) of Task Order 1, offerors should assume only two (2) to three (3) protocols will be supported, which include: Task Order 2 (Protocol 2040) and Task Order 3 (Protocol 2024). For Year 2, assume the three original plus 4 new protocols the second year for a maximum of 7. For Years 3 through 7, it is anticipated that there will be approximately 3 or 4 new protocols for a total of 10 or 11 protocols.

Task Order is anticipated to be a term-form (level of effort) task order, but the labor categories and mix and each offeror’s categories of personnel may vary and are up to the prospective offeror to propose.

B. Travel Uniform Assumptions

The chart below includes travel assumptions for the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) Meetings, NICHD Network Site Visits, Potential Investigator initiated Site Visits, and Annual Meeting of Independent Experts in Emerging Infectious Disease.

Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 TOTAL

Domestic Travel

$193,000 $198,790 $204,754 $210,896 $217,223 $223,740 $230,452 $1,478,855

International Travel

$281,400 $289,842 $298,537 $307,493 $316,718 $326,220 $336,006 $2,156,216

The travel assumptions are estimated as follows:

1. International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) meeting:

A 3-day meeting of NICHD and NIAID-funded investigators to plan scientific agenda for the joint IMPAACT Network occurs once a year (spring).

Attendees per meeting:

125 domestic investigators x $12,000 each = $150,000.

58 international investigators x $3,300 each = $191,400

2. NICHD Network Site Visits:

Domestic:

There are 14 main clinical trial sites domestically.

14 sites x 2 visits per year: 28 site visits per year domestically.

28 site visits @ $ 1,000 per visit =$28,000/year

International:

There are 10 international clinical trial sites.

10 sites x 2 visits per year: 20 site visits annually.

20 site visits @ $3,000 each = $60,000/year

3. Potential Investigator initiated Site Visits:

Investigator initiated grants that undergo site monitoring by the contractor:

Maximum 5 sites x 2 visits per year: 10 site visits annually

5 site visits (international) @ $3,000 = $15,000

5 site visits (domestic)@ $1,000=$5000

4. Potential Annual Meeting of Independent Experts in the area of Emerging Infectious Disease

Potential Annual meeting of domestic experts in an area of emerging scientific interest.

10 domestic experts x $1,000=$10,000

5 international experts x $3,000=$15,000

NOTE: All supporting services including travel will be covered under Task Order 1. Therefore, there are no travel assumptions included for Task Order 2 and Task Order 3.

C. Laboratory Support and Repository Requirements

Laboratory Support: Standard laboratory evaluations conducted as part of clinical trial protocols are part of the site subcontracts as part of Tasks 2 and 3 and not Task Order 1. They are billed on a cost-reimbursement basis after patients are seen.

Specialized laboratory assays should not be proposed for any of the task orders in this RFP. Specialized laboratory assays may include laboratory developed and/or research-use-only virology, immunology, pharmacology, and/or other laboratory methods that will be specified in future task orders and for which anticipated test volume and cost will be incorporated into budgets associated with those future task orders. Budgeting for central laboratory is not required although existing relationships with specialty laboratories may be advantageous and may be described in your proposal.

PK sample analysis for Task Order 2 and Task Order 3 will be performed by IMPAACT specialty pharmacology laboratories. The cost of that laboratory analysis should not be included in the budget. Other Costs associated with sample collection, processing, transport, shipping, and storage are included in the specific task order uniform assumptions in the total for subcontracting with the clinical sites.

D. Repository Requirements

The Offeror shall make the following uniform cost assumptions for repository storage of the documents and specimens:

1) FioCruz, Rio de Janeiro, Brazil - $50,000 per year for storage of specimens and documents for clinical sites in Brazil.

2) WITS, Johannesburg, South Africa - $20,000 per year for storage of specimens for clinical sites in Africa.

3) Fisher BioServices, Rockville, MD - $55,000 for storage per year of specimens for clinical sites in the US.

Uniform assumptions for subsequent years: $125,000/year

Task Order 2: “IMPAACT 2040 – Pharmacokinetics and Safety of Long-Acting Injectable Cabotegravir and Rilpivirine in Virally Suppressed Women with HIV During Pregnancy and Postpartum”

A. Task Order 2 – This protocol will require the approximate sample size and visit numbers as follows: Up to 90 participants with up to 495 visits (45 pregnant women with up to 8 visits each and 45 infants with up to 3 visits each).

B. The duration of the study participants is anticipated to be approximately six months for maternal participants and approximately six weeks for infant participants.

C. This task order will result in a cost-reimbursement completion type task order for a period of performance of three (3) years. Offerors shall use a uniform assumption for subcontracting for the clinical sites under this task order estimated at $900,000.

Task Order 3 – “IMPAACT 2024 -Phase I/II Dose-Finding, Safety and Tolerability Study of Daily Rifapentine Combined with Isoniazid (1HP) for Tuberculosis Prevention in Children Two to less than 13 Years of Age with and without HIV.”

A. Task Order 3 – The IMPAACT protocol 2024 study design will be a Phase I/II, multi-site, open-label, non-comparative dose-finding study. The study population will consist of Children living without HIV (Cohort 1) and children living with HIV (Cohort 2) at risk of TB disease who are two to less than 13 years of age. Cohort 2 will be receiving an anti-retroviral treatment regimen containing dolutegravir (DTG). This protocol will require the following approximate sample size and visit numbers: Up to 132 participants with up to 1,092 visits (cohort 1 = up to 96 participants with up to 8 visits each; cohort 2 = up to 36 participants with up to 9 visits each). Offerors shall use the value of “up to 132 participants” for IMPAACT 2024 accrual listed in the solicitation. The value of 80 that is included in the IMPAACT “Study Snapshot” online document refers to the minimum number of evaluable participants.

B. The study duration is anticipated to be approximately 36 months total. Accrual is expected to require approximately 30 months (from the date of the first enrollment) and participants in each cohort will be followed for 24 weeks.

C. This task order will result in a cost-reimbursement completion type task order for a period of performance of four (4) years. Offerors shall propose a uniform assumption estimated at $2,000,000 for subcontracting for the clinical sites under this task order.

PREPARATION OF THE TECHNICAL AND BUSINESS PROPOSAL

In addition to the format requirements for the Business Proposal that are contained in Section J and L of the solicitation, the information presented here intends to provide uniform cost assumptions and business clarifications to assist in the preparation of your proposal.

• Budget Format: Offerors should submit cost proposals for Task Orders (TO) 1, 2, and 3 only. A cost proposal is not requested for the Base IDIQ Contract. Please refer to Estimate of Effort above for the Level of Effort in Task 1.

• Organization of Technical Proposal and PAGE LIMITS:

Offerors are requested to write their Technical Proposal in four (4) parts:

TECHNICAL PROPOSAL BUSINESS PROPOSAL

The offeror must submit one (1) electronic PDF file for the Technical Proposal with the following sections included:

Offerors are requested to write their Technical Proposal in four

(4) parts:

First Part - shall address the IDIQ Contract Statement of Work and shall not exceed 30 single spaced pages. Parts 2 through 4 - (separate parts of the Technical Proposal) shall address Task Orders Nos. 1, 2, and 3 and shall not exceed 20 single spaced pages each. PROPOSAL PAGE LIMITS exclude resumes. Also excluded from the page limits are: Summary of Related Activities, Table of Contents, Proposal Cover Sheet, Technical Proposal Direct Cost Summary Sheet, Resumes, Bibliography/ References, Human Subjects Separate File, and Section 508 Template. The Human Subjects Separate File in the Technical Proposal does not have a page limit. The Data Sharing Plan may be in Summary Form in the 30-page technical proposal and the Summary is not excluded from the page limits. If an offeror elects to provide a more expanded data sharing plan, the expanded plan can be an Appendix and is excluded from the page limits.

Pages that exceed the page limit requirements will not be read, evaluated, or considered for review. Issues that need to be addressed in Task Order 1, Task 2 and Task 3, which have already been detailed in Technical Proposal in response to the IDIQ Contract Statement of Work, should be referenced in the second, third, and fourth parts of your technical proposal rather than repeating passages.

The offeror must submit one (1) electronic PDF file for the Business Proposal* with the following sections included:

1. Task Order 1 –“Support Services for HIV Network Tasks”

2. Task Order 2 – IMPAACT Protocol – 2040

3.Task Order 3 – IMPAACT Protocol 2024

In addition, the Offerors must include the Excel Spreadsheet with the Breakdowns of the Proposed Estimated Costs.

*It should be noted that the IDIQ does not require a business proposal.

There are no page limits in the Business Proposal. Past Performance is included in the Business Proposal.

PLEASE REFER TO ATTACHMENT 1 – PACKAGING AND DELIVERY OF

PROPOSAL FOR INSTRUCTIONS ON SUBMITTING THE PROPOSALS.

• The scoring in the technical evaluation will be based on a comprehensive review of all four parts of the Technical Proposal (Statement of Work – Base IDIQ Contract, Task Order No. 1, Task Order No. 2 and Task Order No. 3, not on each individual Task Order. The Task Order proposals will not be scored separately.

• It is anticipated that Task Order Nos. 1 through 3 will be awarded simultaneously with the Base Contract.

IMPAACT 2024, DRAFT Version 0.40 Page 1 of 3 31 October 2022

IMPAACT 2024 - Attachment 10 - Appendix I-A: Cohort 1 (Participants without HIV) – Schedule of Evaluations

Study Visit Screening up to -21 days Entry Day 7 Day 14 Day 21 Day 28 Day 42 Day 168

(24 Weeks) Early DC

CLINICAL EVALUATIONS

Medical and Medication History X X X X X X X

Review adherence to 1HP regimen X X X X [X]

Physical examination X X X X X X X

TB Symptom Screen X X X X X X X

Palatability/Acceptability Questionnaire X X X

Tuberculin Skin Test2 [X]

Administer initial dose of 1HP regimen1 X

LABORATORY EVALUATIONS

HIV testing (if needed) [0-6 mL]

IGRA2 (if needed) [4 mL]

CBC with differential and platelets 1 mL 1 mL 1 mL

ALT, AST, albumin, total bilirubin, direct bilirubin, creatinine, eGFR , 2 mL 2 mL 2 mL 2 mL

Electrolytes (sodium and potassium)3 2 mL X X X

Pharmacogenomic testing4 [0.5 mL] [0.5 mL] [0.5mL] [0.5mL]

PK SAMPLING

RPT PK sampling 2.5 mL 1.5 mL

Total Maximum Blood Volume 3 - 13 mL 2 - 2.5 mL 0 mL 5.5 - 6 mL 0 mL 4.5 - 5 mL 2 - 2.5 mL 0 mL 0 mL

1. The date of initiation of 1HP regimen is considered day 1 and all subsequent follow-up visits will be counted from this date.

2. At Screening, TST or IGRA should be performed if needed to determine eligibility per inclusion criterion 4.1.5 (i.e., only one required).

3. At Days 14, 28, and 42 visits electrolytes may be tested from same sample collected for ALT, AST, albumin, total bilirubin, direct bilirubin, and creatinine.

4. For participants who provide consent for genetic testing only, one sample for pharmacogenomic testing should be collected at one visit from Entry through Day 42 visit.

IMPAACT 2024, DRAFT Version 0.40 Page 2 of 3 31 October 2022

Appendix I-B: Cohort 2 (Participants Living With HIV) – Schedule of Evaluations

Study Visit Screening up to -21 days Entry Day 7 Day 14 Day 21 Day 28 Day 42

Day 168 (24 Weeks)

Repeat

HIV RNA

PCR

Early DC

CLINICAL EVALUATIONS

Medical and Medication History X X X X X X X X

Review adherence to 1HP regimen and

DTG

X X X X X [X]

Physical examination X X X X X X X X

TB Symptom Screen X X X X X X X

Palatability/Acceptability Questionnaire X X X

Tuberculin Skin Test2 (if needed) [X]

Administer initial dose of 1HP regimen1 X

LABORATORY EVALUATIONS

HIV testing (if needed) [0-6 mL]

IGRA2 (if needed) [4 mL]

CBC with differential and platelets 1 mL 1 mL 1 mL

ALT, AST, albumin, total bilirubin, direct bilirubin, creatinine, eGFR

2 mL 2 mL 2 mL 2 mL

Electrolytes (sodium and potassium)3 2 mL X X X

Pharmacogenomic testing4 [0.5 mL] [0.5 mL] [0.5 mL] [0.5 mL]

HIV-1 RNA PCR 5 mL 5 mL 3 mL

CD4 cell count and percentage 1 mL 1 mL

ARV resistance testing (sample stored) 3 mL

PK SAMPLING

RPT PK sampling 1.5 mL

DTG PK sampling 2 mL 1.5 mL 0.5 mL

Total Maximum Blood Volume 8 - 18 mL 5 - 5.5 mL 0 mL 3 - 3.5 mL 0 mL 6 - 6.5 mL 7.5 - 8 mL 1 mL 6 mL 0 mL

1. The date of initiation of 1HP regimen is considered day 1 and all subsequent follow-up visits should be counted from this date. DTG PK sampling must precede administration of the first dose of 1HP. Refer to Section 5.1 for additional information on initiation of twice-daily DTG dosing.

2. At Screening, TST or IGRA should be performed if needed to determine eligibility per inclusion criterion 4.1.5 (i.e., only one required).

3. At Days 14, 28, and 42 visits, electrolytes may be tested from same sample collected for ALT, AST, albumin, total bilirubin, direct bilirubin, and creatinine.

4. For participants who provide consent for genetic testing only, one sample for pharmacogenomic testing should be collected at one visit from Entry through Day 42 visit.

IMPAACT 2040 - Attachment 10 - Appendix I-A: Pregnant/Postpartum Participant Schedule of Evaluations – Cohort 1 and 2 (Scheduled Visits)

Notes: X required;

* - if indicated

1. Complete physical exam required at screening, targeted exam at all other visits

2. Cohort 1 participants enrolling the Q4W Switch Group or the Q4W Continuation Group will receive injections at antepartum visits every 4 weeks (Study Weeks 4, 8, 12, 16, 20, 24, 28, 32).

Cohort 1 participants enrolling in the Q8W Continuation Group will receive injections at antepartum visits every 8 weeks (Study Weeks 8, 16, 24, 32). Cohort 2 participants enrolling in the Q8W Switch Group will receive injections at the week 4 antepartum visit, following by every 8 weeks (Study Weeks 4, 12, 20, 28)

Study Visit Screen Entry Antepartu m Study Wk 2, 6

Antepartum Study Wk 4, 8, 12, 16, 20, 24, 28, 32

Antepartu m Interval5

Pregnancy Outcome

Postpartum Injection

Postpartum Wk 6 (Q4W)/ Wk 10 (Q8W) and Early Termination

Interim Injection Visit

Viral Load Assessm ent Visit

Behavioral Evaluations Acceptability/Tolerability Assessment

X X – only at Week 8, 16

X

Clinical Evaluations Medical and Medication History X X X X X X X X X X Physical Examination1 X X X X X X X X Fetal Ultrasound * *

ECG X

C-SSRS X X

Study Product Administer injectable study products

X X2 * X * X

Laboratory Evaluations Chemistries: Creatinine, Total bilirubin, AST, ALT, Lipase

5 mL 5 mL 5 mL 5 mL 5 mL

Comprehensive Metabolic Panel plus Lipase

5 mL

Hematology: CBC with differential with platelets

3 mL 3 mL 3 mL 3 mL 3 mL 3 mL

Albumin 3 mL – only at Week 8, 16

3 mL 3 mL

Hepatitis C testing: anti-HCV ab 10 mL Hepatitis B: HBcAb, HBsAg, HBsAb

5 mL

CD4 Count and Percentage 3 mL 3 mL – only at Week 12 and Week 24 Confirmatory HIV-1 Testing 0-6 mL* HIV-1 RNA 6 mL 6 mL 6 mL 6 mL 6 mL 6 mL 6 mL 6 mL 6 mL HIV-1 Resistance Testing3 4 mL 6 mL PK Evaluation4 4 mL 4 mL 4 mL 4 mL 4 mL 4 mL 4 mL 4 mL 4 mL Cord blood PK Sample 4 mL6

Chest/Breastmilk sample X7 X7 X7

Offer Pregnancy Test * * Total maximum blood volume 29-35mL 25 mL 10 mL 18 - 24 mL 4 mL 14 mL 21 mL 21 mL T18 mL 16 mL

3. Collect whole blood at entry, plasma at any other timepoints

4. See section 6.1-6.8 for PK sample collection procedures

5. Visit(s) scheduled 7 days after the injection(s) received between 30 0/7 - 37 6/7 weeks EGA

6. If a live birth and visit is performed on day of delivery

7. If currently chest/breastfeeding

Appendix I-B: Infant-Participant Schedule of Evaluations – Cohort 1 and 2

Notes: X – required; * - if indicated

1. If the Infant-Participant Birth Visit does not occur, all procedures listed for the Infant-Participant Birth Visit should be completed at the Five-Day Post-Birth Visit.

2. The at-birth sample may be omitted if cord blood was collected or if the visit cannot be completed on the day of birth.

3. If participant is chest/breastfeeding.

4. Documented HIV-1 NAT results obtained as part of standard of care, external to the study, may be used if the sample was collected within 7 days of the visit.

Study Visit Infant-Participant Birth Visit

Infant-Participant Five Day Post Birth

Visit1

Postpartum Injection Visit

Postpartum Week 6 (Cohort 1)/ Week 10 Visit

(Cohort 2)

Clinical Evaluations

Medical, Medication, and Feeding History X * X X

Complete Physical Examination X *

Targeted Physical Examination X X

Laboratory Evaluations

PK Evaluation 1 mL2 1 mL 1 mL3 1 mL3

HIV-1 NAT4 0 – 3 mL * 0 – 3 mL 0 – 3 mL

Total Maximum blood volume 0 – 4 mL 1 mL 0 – 4 mL 0 – 4 mL

ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT CONTRACT WITH NON-

PROFIT ORGANIZATIONS OTHER THAN EDUCATIONAL INSTITUTIONS

This contract incorporates the following 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 as follows: FAR Clauses at: http://www.acquisition.gov/far/ . HHSAR Clauses at:

http://www.hhs.gov/policies/hhsar/subpart352.html .

a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:

FAR

CLAUSE NO.

DATE TITLE

52.202-1 Jun 2020 Definitions (Over the Simplified Acquisition Threshold) 52.203-3 Apr 1984 Gratuities (Over the Simplified Acquisition Threshold) 52.203-5 May 2014 Covenant Against Contingent Fees (Over the Simplified

Acquisition Threshold) 52.203-6 Nov 2021 Restrictions on Subcontractor Sales to the Government (Over the Simplified Acquisition Threshold) 52.203-7 Jun 2020 Anti-Kickback Procedures (Over the Simplified Acquisition

Threshold) 52.203-8 May 2014 Cancellation, Rescission, and Recovery of Funds for Illegal or

Improper Activity (Over the Simplified Acquisition Threshold) 52.203-10 May 2014 Price or Fee Adjustment for Illegal or Improper Activity (Over the Simplified Acquisition Threshold) 52.203-12 Jun 2020 Limitation on Payments to Influence Certain Federal

Transactions (Over the Simplified Acquisition Threshold) 52.203-17 Jun 2020 Contractor Employee Whistleblower Rights and Requirements to Inform Employees of Whistleblower Rights (Over the Simplified Acquisition Threshold)

52.203-19 Jan 2017 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements

52.204-4 May 2011 Printed or Copied Double-Sided on Postconsumer Fiber Content Paper(Over the Simplified Acquisition Threshold)

52.204-10 Jun 2020 Reporting Executive Compensation and First-Tier Subcontract Awards

52.204-13 Oct 2018 System for Award Management Maintenance 52.204-25 Aug 2020 Prohibition on Contracting for Certain Telecommunications and

Video Surveillance Services or Equipment 52.209-6 Nov 2021 Protecting the Government's Interest When Subcontracting

With Contractors Debarred, Suspended, or Proposed for Debarment

Attachment 11 http://www.acquisition.gov/far/ http://www.hhs.gov/policies/hhsar/subpart352.html

FAR

CLAUSE NO.

DATE TITLE

52.215-2 Oct 2010 Audit and Records - Negotiation [Note: Applies to ALL contracts funded in whole or in part with Recovery Act funds, regardless of dollar value, AND contracts over the Simplified Acquisition Threshold funded exclusively with non-Recovery Act funds.], Alternate II (Aug 2016)

52.215-8 Oct 1997 Order of Precedence - Uniform Contract Format 52.215-10 Aug 2011 Price Reduction for Defective Certified Cost or Pricing Data

(Over $750,000) 52.215-12 Aug 2020 Subcontractor Certified Cost or Pricing Data 52.215-14 Nov 2021 Integrity of Unit Prices (Over the Simplified Acquisition

Threshold) 52.215-15 Oct 2010 Pension Adjustments and Asset Reversions (Over $750,000) 52.215-18 Jul 2005 Reversion or Adjustment of Plans for Post-Retirement Benefits

(PRB) other than Pensions 52.215-19 Oct 1997 Notification of Ownership Changes 52.215-21 Nov 2021 Requirements for Certified Cost or Pricing Data and Data Other

Than Certified Cost or Pricing Data - Modifications 52.215-23 Jun 2020 Limitations on Pass-Through Charges (Over the Simplified

Acquisition Threshold) 52.216-7 Jun 2013 Allowable Cost and Payment, Alternate IV (Aug 2012) 52.216-11 Apr 1984 Cost Contract - No Fee 52.219-8 Oct 2022 Utilization of Small Business Concerns (Over the Simplified

Acquisition Threshold) 52.219-9 Oct 2022 Small Business Subcontracting Plan (Over $700,000, $1.5 million for Construction) 52.219-14 Oct 2022 Limitations on Subcontracting 52.219-16 Jan 1999 Liquidated Damages - Subcontracting Plan (Over $700,000, $1.5 million for Construction) 52.222-2 Jul 1990 Payment for Overtime Premium (Over the Simplified Acquisition

Threshold) (Note: The dollar amount in paragraph (a) of this clause is $0 unless otherwise specified in the contract.)

52.222-3 Jun 2003 Convict Labor 52.222-21 Apr 2015 Prohibition of Segregated Facilities 52.222-26 Sep 2016 Equal Opportunity 52.222-35 Jun 2020 Equal Opportunity for Veterans ($150,000 or more) 52.222-36 Jun 2020 Equal Opportunity for Workers with Disabilities 52.222-37 Jun 2020 Employment Reports on Veterans ($150,000 or more) 52.222-40 Dec 2010 Notification of Employee Rights Under the National Labor

Relations Act (Over the Simplified Acquisition Threshold) 52.222-50 Nov 2021 Combating Trafficking in Persons

DATE TITLE

52.222-54 May 2022 Employment Eligibility Verification (Over the Simplified Acquisition Threshold)

52.223-6 May 2001 Drug-Free Workplace 52.223-18 Jun 2020 Encouraging Contractor Policies to Ban Text Messaging While

Driving 52.225-1 Nov 2021 Buy American - Supplies 52.225-13 Feb 2021 Restrictions on Certain Foreign Purchases 52.227-1 Dec 2007 Authorization and Consent, Alternate I (Apr 1984) 52.227-2 Jun 2020 Notice and Assistance Regarding Patent and Copyright

Infringement 52.227-11 May 2014 Patent Rights - Ownership by the Contractor (Note: In accordance with FAR 27.303(b)(2), paragraph (e) is modified to include the requirements in FAR 27.303(b)(2)(i) through (iv).

The frequency of reporting in (i) is annual.

52.227-14 Dec 2007 Rights in Data - General, Alternate IV (Dec 2007) 52.232-9 Apr 1984 Limitation on Withholding of Payments 52.232-20 Apr 1984 Limitation of Cost 52.232-23 May 2014 Assignment of Claims 52.232-25 Jul 2013 Prompt Payment, Alternate I (Feb 2002) 52.232-33 Oct 2018 Payment by Electronic Funds Transfer--System for Award

Management 52.232-39 Jun 2013 Unenforceability of Unauthorized Obligations 52.233-1 May 2014 Disputes 52.233-3 Aug 1996 Protest After Award, Alternate I (Jun 1985) 52.233-4 Oct 2004 Applicable Law for Breach of Contract Claim 52.242-1 Apr 1984 Notice of Intent to Disallow Costs 52.242-3 Dec 2022 Penalties for Unallowable Costs (Over $700,000) 52.242-4 Jan 1997 Certification of Final Indirect Costs 52.242-13 Jul 1995 Bankruptcy (Over the Simplified Acquisition Threshold) 52.243-2 Aug 1987 Changes - Cost Reimbursement, Alternate V (Apr 1984) 52.244-2 Oct 2010 Subcontracts (Over the Simplified Acquisition Threshold), Alternate I (June 2007) 52.244-5 Dec 1996 Competition in Subcontracting (Over the Simplified Acquisition

Threshold) 52.244-6 Dec 2022 Subcontracts for Commercial Products and Commercial Services 52.245-1 Apr 2012 Government Property, Alternate II (April 2012) 52.245-9 Apr 2012 Use and Charges 52.246-23 Feb 1997 Limitation of Liability (Over the Simplified Acquisition

Threshold) 52.249-6 May 2004 Termination (Cost-Reimbursement) 52.249-14 Apr 1984 Excusable Delays

DATE TITLE

52.253-1 Jan 1991 Computer Generated Forms

b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48

CFR CHAPTER 3) CLAUSES:

HHSAR

CLAUSE NO.

DATE TITLE

352.203-70 Dec 2015…