Amend_2_to_RFP_1-12-23_Posted_0002.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.