Amendment_0001_Questions_and_Answers_75N94025R00008_0001.pdf

AMENDMENT 0001 Questions and Answers RFP 75N94025R00008 “Clinical Research Organization for the National Institute on Alcoholism and Alcohol Abuse Medications Development Clinical Trials Network”

GENERAL

1) Who is the current incumbent and what is the contract award number?

ANSWER:

The incumbent contractor is Fast-Track Drugs & Biologics, LLC under IDIQ contract 75N94019D00001 (and also the contract prior to that, IDIQ contract HHSN27520140001I).

2) In instances where a statement of work (SOW) references “days” but does not specify “business days” or “calendar days,” are these calendar days or business days?

ANSWER:

Assume calendar days unless stated otherwise. (The caveat is if a due date for a deliverable falls on a weekend or Federal Holiday, it is assumed the deliverable is due the following business day).

SECTION G – KEY PERSONNEL

Page 20 of RFP

3) The solicitation discusses several proposed personnel roles and qualifications, and Section G.8 identifies Key Personnel as “to be specified prior to award” for the Project Director. Please clarify which personnel, if any, must be proposed as Key Personnel in the offeror’s proposal, and whether the Government expects only the Project Director to be designated as Key Personnel or additional roles as well.

ANSWER:

The following positions are anticipated to be identified as Key Personnel in the awarded contract: 1) Project Director; 2) Senior Clinical Manager (Monitor); and 3) Director of Biostatistics.

SECTION H – Cloud Services/FedRAMP Compliant ATO

Pages 43-44 of RFP

4) In lieu of the FedRAMP Compliant ATO, will the Government accept a commercial off the shelf (COTS) system which has an active FISMA Moderate Authorization to Operate (ATO) as evidence of compliance, subject to NIH review of the authorization package, system boundary, control implementation, POA&M, continuous monitoring, and any NIH or NIAAA-specific requirements?

ANSWER:

If a COTS application resides on a FedRAMP certified cloud Infrastructure or Platform as a Service, it will be considered. That consideration will depend on whether the contractor adequately describes the degree to which the remainder of security controls that contractor is responsible for, which are applicable to the system and application, are in keeping with FedRAMP standards.

SECTION L, PROPOSAL INSTRUCTIONS

Page 93, Gov’t Excel budget spreadsheet for proposal submission

5) Are offerors allowed to use their own Cost Sheet in place of the govt excel sheet (attachment 10)?

ANSWER

No. Offerors MUST utilize the NIH excel budget template (Attachment 10 – link provided in Section J of RFP, pages 93-94).

Page 108, Technical Proposal Instructions, NIH Policy on enhancing Reproducibility through Rigor and Transparency

6) Are offerors required to address the requirement related to the NIH Policy on enhancing Reproducibility through Rigor and Transparency (NIH Guide Notice NOT-OD-15-103)? The solicitation states “the information described below” but does not include any subsequent text or specific elements to address after the colon. If offerors are required to address the policy, can the specific elements to address after the colon be provided?

ANSWER:

The field under “Specifically, the offeror shall describe in its technical proposal the information described below:” was unintentionally left blank.

The following information is hereby added via this Solicitation amendment:

Section L, TECHNICAL PROPOSAL INSTRUCTIONS, Item d. (page 108 of RFP):

d. Enhancing Reproducibility through Rigor and Transparency

The offeror shall demonstrate compliance with the NIH Policy on enhancing Reproducibility through Rigor and Transparency as described in NIH Guide Notice NOT- OD-15-103 .

Specifically, the offeror shall describe in its technical proposal the information described below:

Describe how you will implement a systematic approach to evaluate and clearly communicate the overall strengths and limitations of prior research cited in support of a pharmacotherapy trial. This will include critically assessing study design, sample characteristics, methodological rigor, consistency of findings, and potential sources of bias. Findings will be synthesized and presented in a balanced manner to ensure the Government receives a transparent and evidence-based appraisal of the existing literature and its implications for a proposed trial.

Page Limits

7) The solicitation provides formatting and submission instructions, but we did not identify page limits for the Technical Proposal, Business Proposal, or attachments. Please confirm whether any page limits apply. If page limits do apply, please specify the limits by volume/section and clarify whether items such as resumes, letters of commitment, technical attachments, the Data Management and Sharing Plan, and required forms are included in or excluded from those limits.

It is confirmed there are no page limits.

SECTION M – EVALUATION FACTORS FOR AWARD

Page 133 – Data Management and Sharing Plan

8) Is a Data Management and Sharing Plan (Plan) required to be submitted with the technical or business proposal or not till after contract award ?

A Data Management and Sharing Plan should be submitted as part of your Technical Proposal.

ATTACHMENT 3 – Additional Proposal Information and Instructions

Page 1, Technical Proposal Document

9) "The Technical Proposal Document should be submitted as a single document with separate sections for each of the two task order requirements contained in the RFP" does this include the Base IDIQ Technical response - Attachment 4 or shall offeror submit Base IDIQ on a separate Technical Document ?

ANSWER:

The Technical Proposal needs to be submitted as a single document. The Technical Proposal should address all aspects of the base IDIQ performance requirements and contain separate sections for the two task orders provided with the RFP. There will be four documents submitted: A Technical Proposal, a Business Proposal and an excel Budget (completed Attachment 10) for each of the two task orders provided with the RFP.

Sample Task Order #1 Assumptions

10) Are monitoring visits expected to be 100% on-site, or is remote acceptable for some visits?

Monitoring visits are expected to be 100% on site but some items, such as Timeline Follow back, can be monitored remotely.

11) “20 monitoring visits” per site or total across all sites?

ANSWER:

Per site.

12) How many in-person meetings are anticipated (it says “other face to face meetings… frequency

TBD”)?

One (1) per year.

ATTACHMENT 4 – Base IDIQ Contract SOW

13) Is TMF support needed? If TMF support is needed, will the ECM serve as the eTMF system?

ANSWER:

Yes – TMF support is needed but the ECM chosen by the Contractor can serve both purposes.

14) How many task orders are expected per year?

ANSWER:

It is unknown how many task orders will be issued in a given year, but it is anticipated that four to six CRO clinical study support task orders will be issued over the seven-year ordering period of the RFP.

15) Confirm there is no requirement to submit a Cost Sheet or Business Vol for the Base IDIQ.

ANSWER:

The Base IDIQ contract will not have funding attached; and no excel budgets (Attachment 10) need to be submitted for the Base IDIQ contract. Only submit excel budgets for each of the two task orders included in the RFP.

Page 11, Section III (E) Technical Requirements – Transition

16) Scope of ongoing studies -- Can the Government provide an estimate of the studies that will be ongoing at the point of contract transition? If ClinicalTrials.gov IDs are not available, attributes of interest include number of studies, number of enrollees, locations of sites, nature and schedule of intervention, estimated end of studies.

ANSWER:

The “transition plan” cited is for the contractor to transition data to the NIAAA, not to a successor CRO contractor. All of the CRO Clinical Study Support task orders issued under the base IDIQ contract are completion-type and are not “handed off” to a successor CRO contractor prior to completion. The IDIQ ordering period is the time window in which new task orders may be issued. Once an order is issued, it is to be completed in its entirety even if the completion date of the task order extends beyond the base contract IDIQ ordering period.

ATTACHMENT 5 – Base IDIQ Deliverables, page 1 and ATTACHMENT 7, Sample Task Order #1, page 13

17) Table under “Final Reports”, under “Final Clinical Study Report”

The language in the table defining the Final Clinical Study Report seems to refer to a Final Progress Report. Is the final CSR a final progress report, or a traditional clinical study report (i.e., a regulatory document detailing the study's design, conduct, results with tables, listings, and figures, etc.)

It refers to the final clinical study report required by the FDA.

ATTACHMENT 7, Sample Task Order #1

18) How many protocol amendments should be assumed?

ANSWER:

Two (2) amendments.

19) Should the active and Placebo storage be assumed as: Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature.]?

ANSWER:

Yes.

20) How many DSMB teleconferences are expected and at what frequency? How many DSMB members? Are all meetings remotely conducted? If on-site meetings are required, please provide specifics (e.g., location, length, etc.).

ANSWER:

Assume 1 teleconference every 6 months, 3 members, remote only.

21) Is the CRO responsible for processing DSMB payments?

ANSWER:

The NIAAA DSMB is not paid.

22) Is the CRO required to develop a master ICF template for submission to the sIRB for approval or should we assume site-specific ICFs that each require sIRB approval?

The CRO, with input and approval from NIAAA, will develop the ICF template.

23) For each study, is CRO responsible for review/approval of each site consent (including periodic revisions, as required by study) prior to IRB submission?

ANSWER:

Yes.

24) Are the required site visits (initiation, interim and close-outs), on-site? If not, please provide the length and number of on-site vs. remote visits?

Yes – all on-site visits.

ANSWER:

25) What is the length of each type of site visit?

ANSWER:

Two (2) days for Initiation visit; one (1) day for interim visits; and one (1) day for close-out visits.

26) Regarding coordination and communications meetings, how many meetings are expected to be supported by the CRO? Remote vs. on-site? For on-site meetings, how many attendees will require logistical support (such as lodging, meals, and transportation) and where will these meetings be held (e.g., government properties within the DC Metro area)?

ANSWER:

All remote. Assume one kick-off meeting, 32 regular study calls, and 1 closeout meeting.

27) Is it expected that CRO monitoring is risk-based or comprehensive (100% Source Data Verification)?

ANSWER:

100%.

28) Will labs be processed through a central lab or is it expected that each site’s clinical laboratory will process study labs?

ANSWER:

Site’s clinical laboratory for the purpose of this proposal.

29) Is it expected that an eTMF will be used for the management of essential records?

Yes.