75F4012500059_QA_5-16-25.pdf

1. Clarification of Scope and Staffing

1.1. Can you confirm the total number of FTEs or personnel historically used to support this contract?

Response: Average over the course of the current contract is 36 employees, but not all are full time. The range of employees over the current contract is 32 – 40.

1.2. Are offerors required to propose all 21 labor categories listed in Attachment 2, or only those essential to meeting the PWS?

Response: With the exception of those positions defined and listed as “Key Personnel” in Section 8 of the PWS and Section B.3.2 of the solicitation, offerors are not required to propose all of the remaining categories and are free to submit their own proposed labor mixes/hours to perform successfully, as long as (1) the labor categories submitted are traceable to those listed in the PWS and/or the positions described in Attachment 2, and (2) adequately supported by an accompanying rationale or narrative.

1.3. Will resumes/CVs for key personnel be required at the Phase II stage, and for which roles specifically?

Response: Yes. Please refer to the solicitation beginning at the bottom of page 58 – Section E.2.2.2 PHASE II – Technical.

2. Incumbent Information

2.1. Can the government provide the following information of the incumbent contractor currently performing this work? Name of the firm, contract number, contract title.

Response: Toxicologic Pathology Associates, Inc.; 75F40120C00060; On Site Pathology Services.

2.2. What have been the actual annual spends under the incumbent contract?

Response: Through Option Year 3 (year 4 of the total contract), annual obligations have averaged around $4,544,195.00.

2.3. Could the government provide insight into the reason for recompeting this requirement? Are there any known performance or service delivery challenges with the incumbent that offerors should be aware of when developing our proposed approach?

Response: The contract is being re-competed because the current contract expires on 7/15/2025.

Performance information can’t be provided.

3. Evaluation and Award

3.1. Is this a best-value procurement or lowest price technically acceptable (LPTA)?

Response: See Basis of Award page 69 of the solicitation.

3.2. Although the solicitation is issued under full and open competition, does the government have a preference or intent to award to a small business if technically acceptable?

Response: See Basis of Award page 69 of the solicitation.

3.3. Does the government encourage or prefer teaming arrangements for this requirement? Would an offer that includes a team of specialized firms (e.g., a consortium) be viewed favorably if it enhances technical capability, coverage, and continuity?

Response: Offerors will be evaluated in accordance with the solicitation.

3.4. Can the government provide an estimated contract award date?

Response: Award is anticipated to be on or about July 1, 2025.

3.5. Does the government have any minimum qualifications or mandatory thresholds that offerors must meet in order to be considered for award? For example, is there a required number of years in business, minimum project volume and scope (e.g., number of studies supported annually), or any required licenses, certifications, or federal contracting experience? Can commercial industry experience relevant to the performance work statement be considered?

Response: Attention is directed to the solicitation, specifically beginning with the middle of page 57 and continuing through the top of page 62. This part of the solicitation captures and distills all the technical requirements – from Prior Demonstrated Experience to Past Performance – and what will be evaluated, how they will be evaluated, and the relative order of importance of each Factor or Sub-Factor described therein. In Phase 1, there are no required minimums that an offeror has to meet however the projects must be similar or larger to the work and scale of work currently conducted under this requirement and will be evaluated on the confidence ratings in the solicitation. Projects that are not similar in size and scope may receive lower confidence ratings than projects that are of similar size and scope.

4. Operational Clarifications

4.1. Attachment 2 - Pricing Schedule mentions 21 personnel categories. Can the government confirm the required minimum and preferred qualifications for each personnel category (e.g. years of experience, education, industry experience, tools, etc.)?

Response: With the exception of those positions defined and listed as “Key Personnel” in Section 8 of the PWS and Section B.3.2 of the solicitation, offerors are not required to propose all of the remaining categories and are free to submit their own proposed labor mixes/hours to perform successfully, as long as (1) the labor categories submitted are traceable to those listed in the PWS and/or the positions described in Attachment 2, and (2) adequately supported by an accompanying rationale or narrative. Qualifications for those positions not considered “Key” are at the discretion of the offeror so long as the individuals provide the required services in accordance with the PWS. Offerors are advised that individuals and respective resumes submitted for “Key Personnel” positions shall include proof of current licenses, certifications and/or any other qualifications required for a particular “Key” position.

4.2. Does the government expect contractor personnel to work five days per week on-site year-round, or does the workload fluctuate seasonally?

Response: Contractor is expected to structure employee schedules and workloads based on a normal, five-day work week, with the understanding that some work will be scheduled outside the “normal” hours or days and unscheduled necropsies will be necessary when study personnel or a veterinarian determines that a dead or moribund animal must be necropsied. The workload does not fluctuate seasonally.

4.3. Are offerors expected to provide on-call or emergency support outside of the stated 6:00 AM– 6:00 PM, M–F hours?

Response: Yes. Please see sections 4.2.5 Labor and Cost Estimates and 4.2.6 Scheduling of the PWS, which explicitly state, in part, “pathology services required under this contract are dictated by NCTR management-approved research protocols written by NCTR PIs,” and “Contractor shall maintain a pathology schedule to ensure that work for all protocols is performed efficiently.”

Thus, some protocols may require services to be performed outside the normal workday/hours, to include weekends Other situations may arise wherein an animal becomes moribund or dies, and an immediate necropsy is required regardless of the day or time. Also, under PWS Section

4.3.3 Colony Maintenance, The Contractor shall provide euthanasia, necropsy, and any other techniques required to determine the cause of any deaths or morbidity discovered in the rodent, rabbit, large animal, and zebrafish facilities maintained at NCTR. The FDA veterinarian on duty normally determines whether moribund animals require euthanasia, however, the PI, other study personnel, or the veterinarian of the NCTR Animal Care Contractor may make the determination.

These necropsies are by nature unscheduled but shall be performed as soon as possible to minimize pain/distress for moribund animals and tissue autolysis in dead animals.

4.4. Will the government consider partial staffing solutions, or must the offeror cover all required services?

Response: The Government will not consider “partial staffing solutions.” Offerors are expected to submit proposals and categories of labor which thoroughly address all technical requirements listed in the solicitation.

4.5. Can the government clarify the acquisition model for this requirement? While the solicitation indicates a Labor-Hour contract, will the government issue task orders or other formal requests during the period of performance when specific personnel or services are needed? Or is the contractor expected to maintain continuous, full-scope coverage across all 21 categories throughout the contract?

Response: The Government considers this effort a stand-alone, single award Labor Hour contract, and accordingly does not anticipate issuing task or delivery orders against it. With the exception of those positions defined and listed as “Key Personnel” in Section 8 of the PWS and Section B.3.2 of the solicitation, offerors are not required to propose all of the remaining categories and are free to submit their own proposed labor mixes/hours to perform successfully, as long as (1) the labor categories submitted are traceable to those listed in the PWS and/or the positions described in Attachment 2, and (2) are adequately supported by an accompanying rationale or narrative.

Offerors are reminded that sections 4.2.5 Labor and Cost Estimates and 4.2.6 Scheduling of the PWS set forth Contractor requirements for providing cost/labor estimates for each approved protocol; accordingly, workloads may vary from time to time based on volume and/or scheduling of services required or other, extenuating circumstances, but the Contractor is expected to be prepared to perform any specifically required services under any and all protocols during the contract.

5.1 The list of key personnel provided in the solicitation under Section B.3.2 Contractor Key Personnel does not include the position of "Pathologist". Does the government intend to include the Pathologists assigned to the contract resulting from this solicitation as Key Personnel subject to Section B.3.2? If so, should this Section be amended to include the position of Pathologist?

Response: We are not adding the Pathologist position to the Key Personnel list at this time.

5.2 Section B.2.10-B of the solicitation makes reference to individuals "approved for telework" noting that "Telework hours must be approved by the COR in advance". We recognize the necessity of all staff working a regular and consistent schedule "On-Site", however telework can be an essential aspect of maintaining continued operations, particularly in special circumstances such as for inclement weather/government closure. Does the reference to telework in this section indicate that government intends to allow for limited teleworking as approved by the COR as part of the routine services provided under this contact.

Response: Yes, subject to the guidance listed in Section B.2.10-B of the solicitation.

5.3 It is our understanding that contractor employees are expected to park in the general parking lot located just outside of the main entrance gate of the Center. We are also aware that in the past, upon government approval of a special request, employees with disabilities have been provided a reasonable accommodation and were allowed to drive onto the site through one of the security gates and park in designated areas typically much closer to the building where the employee works. Does the government expect to continue to provide reasonable accommodations for contractor employees with disabilities and allow them to drive onto the center and park in designated areas closer to their place of work? If not, what accommodations will the government provide to assist these individuals in getting from the main entrance gate to the on-site building where they work?

Response: Reasonable accommodations are a matter of discretion between the Contractor and their employee, to the extent that any accommodations shall be compliant with current FDA/NCTR policies.