RFP_No__75N93022R00040_Questions_and_Responses_0002.pdf

NIAID DMID CROMS

Solicitation Number: 75N93022R00040 Questions August 18, 2023

Solicitation Section Reference

Questions Responses

Article I A listing of the FAR clauses is missing from Article I; can the government please provide a listing of the FAR/HHSAR clauses expected under the contract?

For the Solicitation, only General Clauses are referenced under I.1. The specific General Clauses will be listed if, and when an award is made. The General Clauses can also be accessed at the link provided in the solicitation.

Article C.2.K.i “Information and/or Physical Security, page

Article K.i (p.13) states "the Contractor (and/or any subcontractor) must 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), investigation, and audit to safeguard against threats and hazards.” 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?

The Government is willing to allow the Contractor to provide vulnerability scans.

Article H.13.1.A.b.iv (p.27); see also H.13.4.b.iii and H.13.4.b.v, pages 29-30

Article H.13.1.A.b.iv (p.27) states that the contractor should “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, to the government representative(s).” Please confirm if the Government is willing to modify the one

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

No, it is necessary for the (1) hour requirement to remain in place.

Article H.13.10, Article H.13.10 (p.33) references a “High Value Asset” but does not appear to include a working link or source in footnotes 23-24. Can the government

Please use the below links for reference purposes:

Questions August 18, 2023 please identify or provide the source documentation/policy for the High Value Asset program?

Please also indicate if any High Value Assets are anticipated to be used in performance of this Agreement.

https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/hhs-ocio-policy-for-management-of-the-enterprise-it-system-inventory.html https://www.cisa.gov/resources-tools/resources/high-value-asset-control-overlay

The Government does not know if any High Value Assets will be used for the resulting contract.

Article B.3.

Estimated Cost

– Option; page

Please confirm the maximum additional allowed FTEs for Options 7B, 8B, 9B, and 10B (covering 04/17/2025 – 04/16/2026) should be 90 FTEs instead of 26 FTEs.

90 FTEs

Article B.3.

Estimated Cost

– Option; page 6 and Attachment 3 – Statement of Work; page 15

Page 6 of the RFP specifies that Option 11 (Beginning Transition or Transition- In) is projected to be 6 months in length (04/17/2024 – 10/16/2024); however, page 15 of Attachment 3 (SOW) states the Initial Transition should be completed within 4 months. Please confirm whether offerors should assume 4 months or 6 months for the Initial Transition.

Offerors should assume up to 6 months for the Initial Transition.

Attachment 1 – Packaging and Delivery of Proposal; page 2 of 2 and Attachment 5 – Additional Technical Proposal Instructions;

Please confirm if the 5-page clinical monitoring plan for the hypothetical clinical trial (requested on page 3 of Attachment 5) can be exempt from the 150-page Technical Proposal limit (similar to the Section 508 VPATs).

Yes, the clinical monitoring plan is exempt from the 150-page Technical Proposal Limit.

Article F.3.

Level of Effort;

page 18 and Section L.1.d.

Level of Effort;

Using 2,080 labor hours as a full-time equivalent (FTE), the level of effort tables on pages 18 and 62 both add up to 81.66 FTEs per year. However, the distribution of FTEs across Professional, Technical, and Support is different between the two tables. Can DMID

The tables under Articles B.3. and F.3. are now aligned.

https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/hhs-ocio-policy-for-management-of-the-enterprise-it-system-inventory.html https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/hhs-ocio-policy-for-management-of-the-enterprise-it-system-inventory.html https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/hhs-ocio-policy-for-management-of-the-enterprise-it-system-inventory.html https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/hhs-ocio-policy-for-management-of-the-enterprise-it-system-inventory.html https://www.cisa.gov/resources-tools/resources/high-value-asset-control-overlay https://www.cisa.gov/resources-tools/resources/high-value-asset-control-overlay https://www.cisa.gov/resources-tools/resources/high-value-asset-control-overlay

Questions August 18, 2023 please confirm which of these two tables offerors should use for the guidance/development of their labor mix?

K. Data Management and Information Systems; RFP page 110/SOW

Can the Government provide a list of electronic systems for which both system (servers, source code, executables, reports) and data will be transitioned to a successor contractor?

The current contract requires transfer of “all IT data systems, source code and Object Code, to a successor contractor”. The exact list of systems will be provided by the current contractor if a transition is required.

DMID anticipates the transition of a CROMS Web-library that includes a document library (for protocol related documents), training, SMC/DSMB document and organization system, CSRs, a secure portal for remote monitoring, and a variety of reporting tools.

NIAID also anticipates the transfer of pharmacovigilance data but anticipates that this would not include the system itself, as it is a commercial product.

K. Data Management and Information Systems; RFP page 110/SOW

Can the Government provide a list of electronic systems for which only data will be transitioned?

The exact list of systems will be provided by the current contractor. If a transition is required, DMID anticipates the transfer of pharmacovigilance data will be data only and not include the system itself, as it is a commercial product. It is also possible historical data, from prior contracts, are transitioned without the transfer of the original system.

Attachment 1 - Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website, I. Proposal Submission;

Attachment I

Can the Government confirm whether subcontractors can provide proprietary technical and budget information directly to the government via eCPS or email to the Contracting Officer to eliminate the disclosure of this information to anyone except the government?

Subcontractors should not submit the proposals directly into eCPS. Proprietary technical and budget information can be provided directly to the Contracting Officer via email.

Questions August 18, 2023

I. Safety Monitoring – Attachment 3 Statement of Work, page 6-7

For budget purposes, please provide an estimate of the monthly volume of SAE and non-serious AE per protocol?

Average initial SAE reports = approximately 25/month.

Total events (initials + follow-up) = approximately 85/month. AESI are included in the above estimates.

Non-serious AEs are not reported to CROMS safety.

I. Safety Monitoring – Attachment 3 Statement of Work, page 6-7

Will Offeror be required to provide medical review of individual case safety reports?

Yes, the offeror will be required to provide a medical review prior to DMID MM review.

I. Safety Monitoring – Attachment 3 Statement of Work, page 6-7

Will Offerors be responsible for medical monitoring support, or will that be provided by DMID Medical Officers?

DMID provides Medical Monitoring services.

I. Safety Monitoring – Attachment 3 Statement of Work, page 6-7

Please confirm how many clinical sites are supporting the 245 protocols (200 active protocols at the time of award and 45 new protocols that will be added in Year 1 and annually thereafter)?

There are about 50 sites supporting the active protocols. This number may increase for unique studies (i.e. this was 100 for some COVID-19 treatment trials).

I. Safety Monitoring – Attachment 3 Statement of Work, page 6-7

Please confirm the number of DMID personnel that require direct access to the safety database.

There are fewer than 20 DMID staff members that require direct access, as long as the adequate reports are provided to DMID safety personnel.

I. Safety Monitoring – Attachment 3 Statement of Work, page 7

“Review safety information from other sources, and assess impact on risk and ongoing clinical trials, with submission to the FDA and other regulatory authorities as needed.”

• Please confirm what “other sources” Offerors will be required to review to assess the impact on risk and ongoing clinical trials, with submission to the FDA and other regulatory authorities as needed?

This refers to requirements from the CFR 312.32(c)(1)(ii)), and includes ongoing or completed clinical studies, pooled data from multiple studies, epidemiological studies, and published and unpublished scientific papers.

Information and/or Physical Security. E.

Independent

Please confirm a single 3rd party assessment is required for the ATO, then an annual assessment of the same nature going forward.

Yes, that is correct. A single 3rd party assessment is required for the ATO.

Questions August 18, 2023

Assessment, Attachment 1 -

PACKAGING

AND DELIVERY

OF PROPOSAL

Please confirm if the CVs are excluded from the 150-page limitation.

Yes, CVs are excluded from the 150-page limitation.

SECTION L -

INSTRUCTIONS,

CONDITIONS,

AND NOTICES

TO OFFERORS

Please confirm if one or multiple award(s) are anticipated for this solicitation.

Yes, one award is anticipated for this solicitation.

Can the Government provide Labor Categories for incumbent contractor staff?

For proposal purposes, please use the labor mix indicated under Article F.3. of the Solicitation.

ATTACHMENT

5: ADDITIONAL

TECHNICAL

PROPOSAL

INSTRUCTIONS

SECTION 4:

CLINICAL AND

TECHNICAL

PERSONNEL

Will the Government provide a breakdown of incumbent labor categories and identify which are considered to be key personnel?

The Government cannot provide a breakdown of incumbent labor categories, as this information is confidential.

For proposal purposes, please see Attachment 5 Section 4 of the Solicitation.

ATTACHMENT

8: EVALUATION

FACTORS FOR

AWARD

CRIERION 2:

SCIENTIFIC AND

TECHNICAL

PERSONNEL

Can the Government provide anticipated requirements for Key Personnel qualifications with regard to experience, training: “Appropriateness and adequacy of the education, training, experience, expertise, and proposed levels of effort of the Principal Investigator and scientific and technical staff including subcontractors/consultants for accomplishing the tasks outlined in the Statement of Work and the overall objectives of the solicitation?”

Appropriate staff would be those with experience performing similar activities. This experience could come from contract research organizations (CRO)s, the pharmaceutical /biotech industry, academic institutions, or government. Experience in supporting clinical trials and other clinical research is critical. The principal investigator should have experience (ideally > 10 years) leading a team of people performing activities similar to those in the solicitation. Adequacy of education will be evaluated based on the task area (e.g., appropriate education for safety oversight would include a medical degree or equivalent).

ATTACHMENT

5: ADDITIONAL

TECHNICAL

PROPOSAL

INSTRUCTIONS

SECTION 6:

FACILITIES,

Can the Government provide a list of facilities currently utilized in performance of the existing CROMS contract? or Can the Government provide a list of contractor facility and/or equipment requirements?

The solicitation does not require the use of government facilities. The contract is anticipated to be performed at the contractor’s location(s) and/or at subcontractor/clinical sites as necessary.

Questions August 18, 2023

EQUIPMENT,

AND OTHER

RESOURCES

ATTACHMENT

8: EVALUATION

FACTORS FOR

AWARD PRE-

AWARD SITE

VISIT OR SITE

AUDIT

Can the Government clarify what type of QA/QC activities will be performed for “auditing of their facilities and Quality Assurance and Quality Control (QA/QC) capabilities?”

Audits will be conducted to confirm that the vendor meets sponsor obligations under ICH E6 (R2) 5.2.2 (and subsequent FDA and EMA expectations of vendor oversight). This may include a review of the adequacy of facilities, equipment, SOPs/processes.

C. Business Proposal Instructions 6.

Small Business Subcontracting Plan

Can the Government confirm whether an offeror submitting a proposal as a Prime needs a subcontractor plan if the Prime offeror is already considered a

SDB?

A Prime that is considered a Small Disadvantaged Business does not need to include a Small Business Subcontracting Plan as part of its proposal.

2. Instructions to Offerors A.

General Instructions.

15. Past Performance Information

Can the Government clarify if both the last 5 contracts and current contracts must demonstrate relevancy to CROMS for past performance evaluation?

The offeror should provide a list of as many current and prior contracts that are relevant to the scope of work, in accordance with Section L.2.a.15 of the solicitation. For proposal evaluation purposes please see Section M.7 of the Solicitation.

2. Instructions to Offerors A.

General Instructions.

15. Past Performance Information

Can the Government clarify if both prime and subcontracts can be submitted for past performance evaluation?

Yes, both prime and subcontracts can be submitted for past performance evaluation.

Will the Government consider having either an Industry Day or 1-on-1 meetings for this opportunity?

The Government will not be holding an Industry Day or conducting 1-on-1 meetings for this requirement.