Amendment 4 to RFP Final.pdf

Amendment # 4 to RFP-NIH-NIAID-DAIT-75N93020R00021

Amendment to Solicitation No.:

RFP-NIH-NIAID-DAIT-75N93020R00021

Amendment No. 4 Issue Date: May 11, 2021 Effective Date:

Proposal Due Date:

May 11, 2021

May 24, 2021 3:00 pm (Unchanged)

Issued By: Deborah Blyveis Contracting Officer

NIH/NIAID/DEA

Office of Acquisitions 5601 Fishers Lane Room 3B6* MSC 9821 Rockville, MD 20852

Point of Contact: Deborah Blyveis, Contracting Officer blyveisd@niaid.nih.gov

Name and Address of Offeror: To All Potential Offerors

Offerors MUST acknowledge receipt of the amendment by Amendment numbers and date of the amendments. Failure to receive your acknowledgment of this amendment may result in the rejection of your proposal.

These questions and answers were published yesterday. Please see the revised answer to question #14.

The deadline for submitting questions was April 26, 2021, additional questions will not be accepted.

SECTION 1- QUESTIONS AND RESPONSES

Solicitation Reference (page and section)

Solicitation Reference Text

Question to Government Response

1. Section L.2.b.1.a.1-4 (page 69)

L.2.b.1. Technical Discussions; a.

Statement of Work;

1. Objectives; 2.

Approach; 3.

Methods; 4.

Schedule

The instructions at L.2.b.1.a.1-4 are standard technical solicitation instructions that appear in most NIAID RFPs and are not specific to the requirements the RFP PWS. The RFP also includes Attachment 6 Additional Technical Proposal Instructions. In Attachment 6 under Section 3: Technical Plan/Approach there are additional instructions which are more specifically tailored for the items the RFP wants offerors to discuss regarding clinical monitoring services requested in the PWS. Will the Government consider eliminating the generic instructions in L.b.1.a on page 69 and allow offerors to focus on responding to the instructions in the Attachment 6?

It is difficult to respond to one set of specifically tailored instructions related to clinical monitoring and to a generic set of instructions written without this PWS in mind. For example, the requirement in L.2.b.1.a.4 to provide a schedule for completion of the work and delivery of items specified in the statement of work makes sense when responding to a request for a specific clinical study, but does not flow naturally when the PWS is seeking clinical monitoring services across a large number of currently unknown studies and the RFP requirement is primarily to bid a set number of labor hours per period.

No changes to the RFP will be made at this time. Offerors are asked to respond to the best of their ability to the RFP instructions.

2. RFP

Attachment 7:

Additional Business Proposal Instructions and Uniform Cost Assumptions (pages 116 – 119)

Section 3 – Uniform Cost Assumptions Section 4 – Options Section 5 – Table of Contents for Documentation Required Under Section L of the Solicitation

The instructions in Attachment 7 appear to indicate the Government wants Business Proposals to follow the outline of the Sections provided in Attachment 7. We want to confirm the Government is not indicating that all these sections need to be placed into our business proposal as listed in Attachment per the questions below:

a. The 3rd item is “Section 3 – Uniform Cost Assumptions” and it provides a variety of Technical Cost Assumptions regarding site monitoring visits; activities to be assumed at the start of the contract; new activities; and travel assumptions. Please confirm the Government does not require us to have a section of the business proposal labeled “Section 3 – Uniform Cost Assumptions” and that we can address the cost aspects of these assumptions as we see fit in our business proposal and the supporting spreadsheets? If it is required, please clarify how the Government would like us to address these assumptions in the proposal beyond being certain that our pricing accounts for these items?

b. Section 3 – Uniform Cost Assumptions also lists subheaders labeled “3) Special Shipping and Packaging;

and 4) Storage” which may have been inadvertently included. Please confirm the Government does not anticipate costs related to either of these items or provide

a. A section labelled Uniform Cost Assumptions is not required in the Business Proposal.

b. No specific assumptions regarding Special Shipping and Storage are included in the Uniform Cost Assumptions. Include these costs at Offeror’s discretion if applicable.

c. The options statement under Section 4 – Options, in the Uniform Cost Assumption refers to Cost assumptions.

The language on page 3 of Attachment 7 “Options should be presented as a separate part of the Technical Proposal and clearly identified as such.” is removed from the RFP

d. A section labelled Uniform Cost Assumptions is not required.

clarification as to expectations and any appropriate assumptions to include in our pricing?

c. The 4th item is “Section 4 – Options”. This says they should be presented as a separate part of the “Technical Proposal and clearly identify as such.” Please confirm the Government meant this to refer to the “Business Proposal” instead and that the only requirement is that in our detailed pricing spreadsheets we need to clearly identify the costs associated with both sets of options listed in Section 4 of Attachment 7?

d. The 5th item in Attachment 7 is “Section 5 – Table of Contents for Documentation Required Under Section L of the Solicitation”. Please confirm the Government does not require a separate section of the RFP labeled to match Section 5 of Attachment 7 and, instead, that the requirement is only that we include required Section L documentation in our general table of contents at the beginning of the Business Proposal volume.

3. L.2.c.6 Small Business Subcontracting Plan (page 76- 78)

Referencing the requirement for a small business subcontracting plan that specifies 33% subcontracting with small business and additional sub-targets for the various socio-economic categories.

Also reference in RFP Attachment 7 that offerors should assume 93% of clinical studies requiring monitoring will be located in the US and 7% will be located outside the US in the UK and Australia.

For studies being conducted outside the US, does the Government require that the Contractor must include the OCONUS clinical monitoring activities in the total pool of activity to which the small business subcontracting plan applies? It may be very difficult to engage with U.S. small businesses that can support these activities in international locations such as the UK, Australia or other regions like Central or South America. We realize that for proposal purposes it may be difficult to separate the cost of these activities, but during contract performance will the Government require that OCONUS monitoring activities be included in the total pool of activity on which small business subcontracting will be judged?

If the offeror is a small business then they are not required to submit a SBSP.

If the subcontractor is a small business then they are not required to submit a

SBSP.

4. RFP

Attachment 7:

Additional Business Proposal Instructions and Uniform Cost Assumptions (page 116)

Section 3 – Technical Cost Assumptions 1.A.a:

N=560 site monitoring visits/trips each year

Of the 560 visits/trips, what is the expected duration of each visit (1, 2, 3, or 4 days onsite per visit)?

Refer to Attachment 7, Uniform Cost Assumptions, Section 3 that begins on page 116, Technical Cost Assumptions for relevant assumptions.

5. RFP

Additional Business Proposal Instructions

Section 3 – Technical Cost Assumptions 1.A.b.iv: average 8 sites per study

As some of the sites may be involved in multiple studies, what does the Government anticipate the total number of unique sites to be for the program?

Refer to Attachment 7, Uniform Cost Assumptions, Section 3 that begins on page 116, Technical Cost Assumptions, for relevant assumptions.

and Uniform Cost Assumptions (page 117)

Clinical Research Site: Discrete locations (e.g., hospitals, outpatient clinics, health maintenance organizations, community health centers, private practices, clinics) supported and/or sponsored by NIAID where qualified professionals conduct clinical research in accordance with Good Clinical Practice and applicable regulations.

6. Attachment

3: SOW.3.D.4

(page 98)

Referencing the requirement for utilization of the

NIAID CRMS

(DAIT) system and the CSM-T

Please clarify if the offeror will be expected to provide a data management and reporting system and a clinical monitoring tracker or if use of CRMS DAIT and CSM-T will be utilized.

Refer to Attachment 6, Section 3, A, Technical Plan/Approach that begins on page 112, the responsibility of the contractor and Attachment 5, Reporting Requirements and Deliverables, and SOW page 91, Technical Requirements.

Refer to NIAID CRMS Clinical Site Monitoring Tracker component data entry of approximately 30 parameters involving Major Deviations and Site Deficiencies (with QA/QC process) from Site Visit Report(s) and the corroborating Site Visit Report document uploads in:

SOW pages 94 and 98, and Attachment 5, Reporting and Deliverables page 108 for contractor deliverables.

7. Attachment

3: SOW.F.1

Quality Assurance and Quality Control (page 99)

1.Develop and implement a Quality Assurance/Quality Control (QA/QC) Plan

Please confirm it is acceptable to use the offeror’s template and policy for the QA/QC Plan or please identify/provide the DAIT template and/or policy if there is one in place that we are required to adhere to.

Refer to Part 1, Section C, Article C.1 a., (page 6), Statement of Work and SOW Section 3, Technical Requirements (page 91) for expectations. The offeror is expected to have and maintain the templates, policies, SOPs (and Project Work Instructions (PWIs), when applicable) and system for effective and efficient QA/QC.

8. Section L.2.c.4 Business Proposal Instructions (page 75)

Requirement for Certified Cost or Pricing Data and Data Other than Certified Cost or Pricing Data under FAR Clause 52.215-

Please confirm that the Government expects sufficient competition such that offerors are not required to submit certified cost or pricing data per FAR 15.403-1(b)(1)?

Please see RFP Article I.2:

b. Alternate IV (October 2010) of FAR Clause 52.215-21, Requirements. for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Data--Modifications (October 2010) is added. Certified Cost or Pricing Data is not required.

9. Attachment 3:

SOW.3.A.1.a.

(page 91-92)

Site Establishment Visits (also referred to as Site Initiation Visits [SIVs])

Please clarify if the description listed in (1)-(3) are referring to Site Establishment Visits or Site Qualification Visits (e.g., Pre-Study Visits), as the tasks listed are generally associated with Site Qualification Visits.

Although overlap in tasks associated with Site Qualification Visit(s) may occur, this is verification that the description is references tasks of Site Establishment Visits (also referred to as Site Initiation Visits).

10. Attach. 6:

Section 6.1 (page 114)

Provide a Project Management Plan for the overall organization that addresses the planning, initiation, implementation, conduct, monitoring, and completion of tasks identified in the SOW.

Please clarify whether the PMP is to be included with the proposal response or within 30 business days after contract award?

Please include the PMP with the proposal.

11. Attach. 3:

SOW.3.E

(page 98)

Referencing the requirement to engage in the conduct of risk-based monitoring research that applies technological and effective solutions

Please clarify the Government’s expectation for risk-based monitoring research.

There is, to date, limited empirical evidence that has advanced the field of effectiveness or efficiencies related to on-site risk-based monitoring: advances in this field is of interest to NIAID. 1,2,3 Refer to Risk-Based Monitoring Innovation content located in the SOW, Reporting Requirements and Deliverables, and Additional Technical Proposal Instructions for pertinent content.

Attachment 7, Uniform Assumptions, is informative of a representative Base Period portfolio composition.

1 US Food and Drug Administration, Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring. 2013. Available at:

http://www.fda.gov/downloads/Drugs/GuidanceCom plianceRegulatoryInformation/Guidances/UCM26 9919.pdf (Accessed 27 Apr 2021).

2 E6(R2) Good Clinical Practice:

Integrated Addendum to E6(R1);

International Council for Harmonisation https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e6r2-good-clinical-practice-integrated-addendum-ich-e6r1 (Accessed 27 Apr 2021).

3 Engen NW, Hullsiek KH, Belloso WH, et al. A Randomized Evaluation of On-site Monitoring Nested in a Multinational Randomized Trial Short title:

Randomized Trial of On-site Monitoring.

Clin Trials 2020;17(1):3-14.

12. RFP

Additional

Section 4 – Options Will the Government please clarify the number of site monitoring visits expected in Options 7-69, so the offeror is able to include travel costs?

SOW Options 7-19 is incremental level of effort that may be exercised. Refer to Attachment 7, Uniform Cost

Business Proposal Instructions and Uniform Cost Assumptions (page 118)

Assumptions, Section 3 that begins on page 116, Technical Cost Assumptions for relevant Base Period assumptions.

13. Amend. 1, Question 8 (page 3)

Page count Due to the many attachments requested in the RFP and their expected page count totaling over 30 pages, will the Government reconsider if the items below may be excluded from the overall page count?

• Project Management Plan

• Summary of Related Activities

• Technical Proposal Cost Summary

• SOP List

• Transition Plan

Please refer to Attachment 1, Section B, Page Limitations and Amendments 1 and 2.

14. Attach 3:

SOW.3.D.4

(page 98)

Referencing the requirement to utilize the NIAID

CRMS (DAIT)

system for entering site monitoring data, uploading site monitoring visit reports and plans, and validating the summary site data entered into the Clinical Site Monitoring Tracker

(CSM-T).

How does the Government foresee the offeror’s CSMC Data Management and Reporting System interacting with the NIAID CRMS (DAIT) system and the Clinical Site Monitoring Tracker (CSM-T)?

Refer to Question 6’s response.

15. Attach. 3:

SOW.3.D.1

(page 98)

Coordination and collaboration with other NIAID contractors

What data will be made available from the SCCC and CDSMC contractors to support the risk-based monitoring?

How will the data from the SCCC and CDSMC contractors be provided to the offeror for integration into the offeror’s CSMC Data Management and Reporting System? Will offeror’s system be required to provide more than read-only access to the SACCC, SCCC, and CDSMC?

Response a: The Contractor’s Clinical Research Associate(s)’ access to relevant clinical and safety databases in their role as site monitors for a given study is necessary, from a Source Data Verification (SDV) and inspection-readiness perspective. How will the data from the SCCC and CDSMC contractors be provided to the offeror for integration into the offeror’s CSMC Data Management and Reporting System?

Response b: Refer to Question 9, Response a. Will offeror’s system be required to provide more than read-only access to the SACCC, SCCC, and CDSMC? Response c: The offeror’s system is only required to provide read-only access to relevant NIAID collaborator members.

16. Attach. 3:

SOW.3.D.1

(page 98)

Coordination and collaboration with other NIAID contractors

If offeror is expected to integrate CDSMC and SCCC data into the Data Management and Reporting System in order to assess risk and manage centralized monitoring, has the government estimated the additional hours required for this activity, expecting that the 41,600 hours in the business

The offeror is not expected to integrate the referenced data into the CSMC Data Management and Reporting System.

Refer to the Response to Question 9 a for additional context.

assumptions was provided based on current support being provided that does not include risk based and centralized monitoring?

17. Please provide more information on Travel for offerors to use for cost purposes? Will travel cost be a Not-exceed amount, if so please provide amount to use.

Refer to Attachment 7, Uniform Cost Assumptions, Section 3 that begins on page 116, Technical Cost Assumptions for relevant assumptions.

18. Are other direct cost (ODC) allowed to be summited in the cost? Or should only direct labor hours be provided to

NIAID.

Other Directs Costs are allowed.

19. Please confirm that the suggested # of labor hours (41,600 per year) is to all the staff (all labor categories - PD+PM+CRA, etc) involved in performing the contract and not for the CRA/monitors alone.

The suggested number of labor hours includes all labor categories.

Amendment # 4 to RFP-NIH-NIAID-DAIT-75N93020R00021