Q and A Document (amended).pdf

Q1: Can you advise on how the response is submitted?

A1: Please email all quotation materials directly to evan.feely@nih.gov.

Q2: In terms of material what are you looking for exactly? A simple pricing sheet or a specific proposal?

A2: All required information and documents are specified in the documents posted to SAM.gov under solicitation number NIH-NINDS-CSS-22-000015.

Q3: We have a question regarding the annual salary (Executive Level II of $199,300). The rate listed in the table below is “exclusive of” fully burdened labor rates which includes wages, fringe benefits, overhead, G&A expenses and profit. In the Attachment 4 Price Template responders are being asked to include the “fully burdened” rate which includes wages, fringe benefits, overhead, G&A expenses and profit, is that correct?

A3: While the HHS Salary Rate Limitation only pertains to an individual’s direct salary, T&M/labor hour contracts must specify fixed hourly rates that include wages, overhead, general and administrative expenses, and profit for each category of labor, which is what the price template is meant to capture. As not every Quoter has an accounting system that allows it to break out individual cost elements, rather than having separate rows within the price template for direct and fully burdened rates for each labor category, we simply have one row for fully burdened rates. We also require Quoters to certify their compliance with the Salary Rate Limitation in the Representations and Certifications attachment.

Q4: Can you please confirm that the letter(s) of commitment should include a narrative demonstrating how Key Personnel satisfy the Personal Qualifications evaluation criteria as describe in Attachment 5? Is there anything else that should be included in these letters?

A4: The only information that must be included in the letters of commitment is 1) whether the proposed “key personnel” are committed to providing the required the level of effort (up to the stated not to exceed (NTE) amounts if the optional line items are fully exercised) and 2) whether they will be or are an employee of the Quoter’s organization as of the anticipated contract start date.

Quoters must also submit a separate narrative demonstrating how proposed Key Personnel satisfy the Personnel Qualifications evaluation criteria but this information does not need to be included in the letters of commitment.

Q5: Will the solicitation require Data Privacy Services or Predictive Analytics and, alternatively, would proposing utilizing Data Privacy and Predictive Analytics for this solicitation be acceptable?

QUESTIONS AND ANSWERS

NIH-NINDS-CSS-22-000015

“Biological Therapeutics Product Development Subject Matter Expert Consultants to Support the Development of Therapeutic

Biotechnology Products (Biologics)” mailto:evan.feely@nih.gov

A5: The only costs the Government anticipates for this acquisition are the labor costs for providing the required consulting services and a small amount for any essential travel. While Quoters are not prohibited from proposing other direct costs, in addition to accounting for them within the price template they must also explain why they believe they are necessary in a separate price narrative.

Q6: Is 541690 the only NAICS code that will be considered for this solicitation?

A6: Yes, as this is a requirement for scientific consulting services, it has been determined that 541690 is the most appropriate NAICS Code. The Government may only use one NAICS Code per requirement, and as this acquisition is being conducted as a total small business set aside, a Quoter must qualify as a small business under the applicable size standard ($16.5M in avg annual receipts) to be considered for award.

Q7: We noticed that there is a requirement to develop a project management plan in accordance with PMBOK method in the event there are multiple performance area contracts.

If we propose a part-time project administrator for the role as a non-key personnel, what estimated LOE should we plan for this specific support activity i.e. project plan setup and administration? Should this be considered as a Direct Billable role or an Other Direct Cost item? In projects with similar requirements we have included them as direct billable resource.

We don’t have a full understanding of the effort involved in setup/administration task – specifically across multiple performance areas. Can we make a reasonable estimate (e.g. 24-40 hours for initial plan setup/review/approval, and then 2-4 hours/month for updates and reporting - depending on the scale of the efforts across different performance areas ?

A7: After further consideration, the Government have decided to remove the referenced project management language from the Statement of Work (SOW) as the program office will be responsible for overseeing the consultants. Accordingly, there will not be a need for a contractor program manager.

Q8: We are considering a potential scenario as outlined here. Can we propose another SME as a non-key personnel to complement the primary key SME personnel in a given performance task area for certain activities ? An example would be to review/edit submission documents to provide input in limited areas where the non-key SME may bring superior experience.

This non-key SME would be available in an ad-hoc capacity and only to the extent NIH authorizes and deems necessary – at the same billing rate as the primary SME. If it is permissible to propose, we can just include the SME’s resume for NIH’s consideration in the RFP response for the task area. If NIH does not approve of the proposed non-key SME, he won’t be included on the contract of course, in the event of a win.

If approved, should such a non-key SME be billed as a Direct Billable resource or Other Direct Cost ?

A8: While the Government only anticipates requiring key personnel to perform the work described in the SOW, contractors are not prohibited from proposing additional personnel if they believe they are necessary to fulfill the requirement. Contractors are required, however, to provide a separate price narrative explaining the need for the additional personnel.

Q9: In the SOW under Performance Area 5, Regulatory Affairs and Regulatory Operations, item f), it states to: “Prepare and submit IND applications to the appropriate regulatory agency.”

From a publishing and submission perspective are there other briefing packages, e.g., Pre-IND, other agency Meeting Requests, and NDA preparation and submissions that should be considered as part of the pricing aspects of this solicitation?

A9: NDA preparation and submissions will not be required, as the NIH programs are providing project support only through Phase 1 or Phase 2.

Preparation and submission of regulatory documents associated with Phase 1 and/or Phase 2 activities such as but not limited to IND submissions, pre-IND meeting requests, responses to regulatory agency correspondence, etc. may be required on a case-by-case basis and upon request by the NIH. The requirements will vary for each program and each project.

Q10: Can past performance be a combination of the prime and subs work?

A10: If this refers to similar work that the Quoter has previously performed as a subcontractor, then yes, this is acceptable, however, the Quoter must clearly identify which work was performed as a prime contractor and which was performed as a subcontractor.

If this refers to previous work performed by proposed subcontractors for the current acquisition, due to the nature of the required services, after further consideration the solicitation has been revised to clarify that any proposed key personnel must be employees of the Quoter. Any proposed key personnel who will not be employees of the Quoter by the contract start date will not be considered.

While the Government does not anticipate any non-key personnel subcontractor support being required, Quoters are not prohibited from proposing it if they explain why they believe it is necessary in a separate price narrative.

Q11: Can the government comment why corporate past performance is required since the scope of the work will be delivered by individual SMEs? As a follow up, would the government consider relevant experience from the SMEs instead.

A11: While past performance is not scored, the Government has included it as an evaluation factor as it has an interest in the extent to which Quoters have previously and successfully provided similar consulting services. Additionally, the Government considers the past performance of individual subject matter expert (SME) consultants as well as corporate past performance to be important considerations.

Regardless of the nature of the Quoter’s organization, whether they are a sole proprietorship or proposing multiple consultants, it’s the organization itself with whom the Government would be contracting, not the individual SME(s). And it is the organization’s employees that would be providing the required consulting services. The Government is interested in knowing whether a Quoter’s employees have successfully performed similar efforts in the past. It is important to note, however, that if relevant past performance is not available, the Quoter will not be scored favorably or unfavorably.

Q12: Can an individual SME be tasked in more than one task area?

A12: Yes, but the Quoter must both demonstrate that the individual has the required expertise in each SME area and that they have the bandwidth to handle multiple projects in multiple areas.

Q13: Is the government stating that the direct salary of any SME proposed cannot exceed that of an Executive Level II? If that is the case, this could limit vendor opportunities to provide part time SME resources, as requested in the RFP, who might result in best value to the government.

A13: The use of the Salary Rate Limitation is not discretionary and is required by the U.S. Department of Health and Human Services (HHS) for all “labor-hour” type contracts. As stated in the clause, the direct salary for any proposed personnel cannot exceed the annual Executive Level II salary (currently $199,300) for any year of the contract. For the current acquisition, 800 labor hours per year is used for this calculation as this represents the total not-to-exceed amount if all optional hours are exercised.

Please note that the salary rate limitation does not restrict the salary that an organization may pay an individual working under an HHS contract or order; it merely limits the portion of that salary that may be paid with contract funds. Thus, a proposed personnel could conceivably have an annual direct salary in excess of the Executive Level II salary rate. The portion that exceeds the rate would simply have to paid by the Quoter.

Q14: How will the government manage multiple vendors and what visibility would the awardees have to ensure understand the program's consistency in delivery, quality, and transparency:

A14: As stated in the SOW, SME consultants will be assigned to individual projects and lead development teams, which will be overseen by Government personnel. As oversight of programmatic issues such as delivery, quality, etc., are solely the Government’s responsibility, no visibility into its internal administrative functions will be provided to awardees.

Q15: We understand that the LOE in a performance area could range from 20-800 hours. Is there any historical average of contract utilization or some other reference NIH could cite to plan for a likely annual LOE on such contracts ? It is obviously dependent on the volume of activity in the program but was wondering if there is any such past reference at all.

A15: The Government is unable to provide an average for actual labor hours used under historical NIH consulting contracts. This is due to the fact that 1) the amount varies widely depending on the nature of the consulting services and the program office’s current needs and 2) as the consulting services under the current acquisition would be supporting new programs, there is no historical precedent to cite.

Q16: The Solicitation requires that the Key personnel narrative be max 2 pages. Request removing this requirement since the overall Phase One requirement is capped at 10 pages.

A16: After consideration, the Government has decided to remove the cap on the Key Personnel narrative and amend the solicitation accordingly. The 10-page cap for all Phase One Documentation (not including Key Personnel Resume(s), Letter(s) of Commitment, and the completed Representations and Certifications and Price Template documents) remains unchanged.