DTT_Response_to_Questions_Sol_75N94026R00002_8_14_26.pdf

RFP 75N94026R00002

Chemistry Research for the DTT

RFP- Questions and Answers

Amendment 2 Answers to question received regarding

Request for Proposal Number 75N94026R00002 Titled Chemistry Research for the Division of Translational Toxicology

The date and time for receipt of proposals is extended. Proposals are due by 4:00 p.m.

September 14, 2026.

1. QuesƟon: General

Does the Government intend to use arƟficial intelligence (AI) tools to assist in the evaluaƟon of proposals? If so, please idenƟfy the AI tools or soŌware that may be used, including whether they are Government-developed applicaƟons or commercially available third-party products.

1. Answer: Government does not intend to use AI tools to assist in the evaluaƟon of proposals.

2. QuesƟon: General

Based on our review of the RFP and the data classificaƟon informaƟon provided, we understand that no personally idenƟfiable informaƟon (PII) or protected health informaƟon (PHI) will be processed, stored, or transmiƩed as part of this engagement. Given the resulƟng low cybersecurity risk profile, would the Agency consider aligning the security requirements with NIST SP 800-171, which is specifically designed to protect Controlled Unclassified InformaƟon (CUI) in nonfederal systems and organizaƟons, rather than the broader NIST SP 800-53 framework?

2. Answer: No personally idenƟfiable informaƟon or protected health informaƟon will be processed, stored, or transmiƩed as part of this engagement. NIST SP 800-171 is an acceptable alternaƟve for this purpose unless otherwise explicitly stated in the contract language.

3. QuesƟon: MulƟple references

Please confirm the SolicitaƟon intent is that the projects submiƩed for Factor 1 Experience and Past Performance are the same.

3. Answer: Yes. The same projects submiƩed for Factor 1 – same examples for Experience may be used for Past Performance, as applicable. However, Experience and Past Performance are separate evaluaƟon factors with a different focus. Experience evaluates the offeror’s demonstrated experience performing projects similar to the work contemplated by the SolicitaƟon, while Past Performance evaluates how well the offeror performed on projects, including applicable past performance informaƟon such as CPARS.

Offerors shall provide the applicable past performance informaƟon in accordance with the SolicitaƟon, including the required evaluaƟon form when CPARS informaƟon is not available.

RFP- Questions and Answers

4. QuesƟon: SolicitaƟon general

To assist offerors in understanding the evaluaƟon process, please clarify whether the technical and business proposals will be evaluated by Government personnel only, external reviewers only, or a combinaƟon of Government and external reviewers.

4. Answer: The technical proposal will be evaluated by a combinaƟon of Government personnel and external reviewers, as appropriate. The business proposal will be evaluated by Government personnel only. All individuals parƟcipaƟng in the evaluaƟon process will be subject to applicable confidenƟality, conflict-of-interest, and procurement integrity requirements. All individuals parƟcipaƟng in the evaluaƟon process will be subject to applicable confidenƟality, conflict-of-interest, and procurement integrity requirements.

5. QuesƟon: SolicitaƟon pages 6-7, SecƟon B.4

The solicitaƟon states that travel and subcontractor costs are unallowable under this contract. However, several other secƟons of the solicitaƟon appear to contemplate contractor travel, including the Technical and Business Proposal InstrucƟons, the Travel Policy, and various provisions within the Packaging and Delivery documents. Please confirm travel and subcontractor costs are allowable if included and, if so, whether offerors should include anƟcipated travel costs in their proposed pricing?

5. Answer: Travel may be authorized for professional meeƟngs for the purpose of presenƟng work conducted under the contract, meeƟngs with Government staff, or other travel as specified by the COR. Subcontracts may be part of the proposal. A Small Business SubcontracƟng Plan is required to be submiƩed to the SBCX system by the due date and Ɵme for proposal submissions.

Any proposed travel, in accordance with the RFP at page 120 J., and subcontracts, in accordance with RFP at page 24 11. SubcontracƟng Provisions, must be approved by the COR and CO prior to award (in accordance with the RFP at page 6-7 Advanced Understandings. Accordingly, if travel and subcontracƟng costs are provided in the proposal, they will be evaluated as proposed.

6. QuesƟon: SolicitaƟon page 25 _11.SubcontracƟng Provisions_5. Individual Subcontract Reports

Will the Government revise the Small Business SubcontracƟng Report due dates from April 30 to May 15 and from October 30 to November 14 to align with current subcontracƟng reporƟng requirements?

6. Answer: Individual SubcontracƟng Report due dates are revised from April 30 to May 15 and from October 30 to November 14.

7. QuesƟon: SolicitaƟon page 25_11. SubcontracƟng Provisions_6. Summary Subcontract Report

Will the Government revise the Small Business SubcontracƟng Report due date to November 14 to align with current subcontracƟng reporƟng requirements?

7. Answer: Summary Small Business SubcontracƟng Report due date is revised to November 14.

8. QuesƟon: SolicitaƟon PDF page 66 [RFP page 65]

RFP- Questions and Answers

Please clarify if offerors are to submit an “HHS SecƟon 508 Product Assessment Template” with their proposal submission, or if this is required post-award. AddiƟonally, if required as part of our proposal, the link provided does not provide a template, are there addiƟonal instrucƟons for accessing this template?

8. Answer: The 508 Conformance Checklist is the only 508 template/checklist required to be provided with the proposal submission.

The following sentence and Link are removed in their enƟrety.

The complete text of the SecƟon 508 Final Provisions can be accessed at hƩp://www.access-board.gov/guidelines-and-standards/communicaƟons-and-it/about-the-secƟon-508-standards.

Added to RFP page 65, paragraph HHSAR 352.239-73 Electronic Informa on and Technology Accessibility No ce. (DEC 2015) (c) Direct Link to Conformance Checklists provided:

hƩps://www.hhs.gov/accessibility/accessibility-checklists/index.html At page 106-107 of the RFP, The following SecƟon 508 accessibility standards are applicable ( ):

300- FuncƟonal Performance Requirements- (Chapter 3- Always Apply - comparable 1194.31) 600- Support Services & DocumentaƟon Standards - (Chapter 6 - Always Apply - comparable 1194.41) WCAG Level A Requirements - (Overlaps with Chapter 4 and 5) WCAG Level AA Requirements- (Overlaps with Chapter 4 and 5)

9. QuesƟon: SolicitaƟon page 118 of the RFP through 119 (through 120 of the pdf)

The solicitaƟon instrucƟons for the Business Proposal includes a secƟon on QualificaƟons of the Offeror, which requires a narraƟve on General Experience, OrganizaƟonal Experience, Performance History, PerƟnent Contracts and PerƟnent Grants. Please confirm the intent is for the offeror to address these items in the Business Proposal, regardless [SIC] of duplicaƟon in the Technical Proposal.

9 Answer: General Experience is removed from the Business Proposal InstrucƟons and added into the Technical Proposal InstrucƟons at page.

10. QuesƟon: SolicitaƟon page 110 3. Small Business subcontracƟng Plan

The solicitaƟon references a $750,000 threshold for subcontracƟng plan requirements. Per FAR 19.702, the threshold increased to $900,000 effecƟve October 1, 2025. Will the Government revise the solicitaƟon accordingly, or should offerors conƟnue to apply the $750,000 threshold when preparing their proposals and subcontracƟng plans?

10. Answer: Threshold is revised to$900,000 threshold in all responses. RFP revised to reflect the $900,000 threshold.

11. QuesƟon: SolicitaƟon page 112 4. Each plan must contain the following: ( ix )

RFP- Questions and Answers

Will the Government revise the solicitaƟon language requiring subcontracƟng plans for subcontractors with awards exceeding $750,000 to align with the current FAR 19.702 threshold of $900,000?

11. Answer: Offerors should use the SubcontracƟng Plan Requirements $900,000 threshold in all responses.

12. QuesƟon: SolicitaƟon page 113 4. Each plan must contain the following: (xi)

Will the Government revise the solicitaƟon language to include the following required FAR clauses: FAR 52.219-9 (D)(12); FAR 52.219-9 (D)(13); FAR 52.219-9 (D)(14); FAR 52.219-9 (D)(15)?

12. Answer: Please see page 110 of the RFP which includes FAR Clause 52.219-9.

13. QuesƟon: aƩ 24_first listed on page 30, 1) (5)

The solicitaƟon requires "report formats" applicable to each Sample Research Outlines. Please confirm the government is asking for ReporƟng Outlines as part of our submission. AddiƟonally, confirm these outlines can be submiƩed as an appendix and are not part of the 200-page limit.

13. Answer: Offerors are not required to provide separate ReporƟng Outlines. In accordance with the solicitaƟon, offerors shall demonstrate how they will meet the requirements applicable to each Sample Research Outline, including applicable report formats, in the technical proposal as part of the 200-page limit. See AƩachment 24, AƩachment B for instrucƟons.

14. QuesƟon: AƩ_24 page 15

Factor 3 (a)(ii) please confirm the requested copies of the Standard OperaƟon Procedures can be provided as an aƩachment and are not part of the 200-page technical page count.

14. Answer: Yes. For Factor 3(a)(ii), copies of the Standard OperaƟng Procedures (SOPs) applicable to the management and technical acƟviƟes may be provided as an aƩachment and will not count toward the 200-page technical proposal page limitaƟon.

15. QuesƟon: aƩ_24 page 6

Please confirm the "Data Management and Sharing Plan" is to be submiƩed as part of the Mandatory QualificaƟon Data in the Technical Proposal.

15. Answer: Yes. The Data Management and Sharing Plan shall be submiƩed as part of the Mandatory QualificaƟon Data in the Technical Proposal.

16. QuesƟon: aƩ_24 AƩachment C

Please confirm that the Government will accept an IDIQ contract as a valid reference for Past Performance and Relevant Experience, provided the IDIQ demonstrates relevant scope, complexity, and performance history aligned with the requirements of this solicitaƟon, and is supported by available performance documentaƟon (e.g., CPARS).

RFP- Questions and Answers

16. Answer: Confirmed. The Government will accept an IDIQ contract as a valid reference for Past Performance and Relevant Experience.

17. QuesƟon: aƩ_24 AƩachment B page 5, AcƟvity 1F (Protocols Development) Page 33 of PDF

Please confirm that Standard OperaƟng Procedures (SOPs) and not protocols are being requested as part of the Protocol Development (PD) task. SOPs are typically prepared as part of the technical tasks (chemical reanalysis and dose analysis) and protocols are typically prepared as part of a PD task.

17. Answer: The reference to Standard OperaƟng Procedures (SOPs) as part of the Protocol Development (PD) task was included in error. Protocols, rather than SOPs, are required as part of the Protocol Development task. The SolicitaƟon is revised accordingly.

18. QuesƟon: AƩachments_package page 2

Will the Government allow contractors to use less than 10 point font size on graphics and tables, e.g., 8 point, as long as doing so maintains readability? Items such as floor plans and large tables of data will be much easier to comprehend if they can remain on one page.

18. Answer: The Government will not permit font sizes smaller than 10 point. As stated in the SolicitaƟon, 12-point font is required for all narraƟve text. Minimal use of 10-point font is permiƩed for tables, figures, and graphics only for formaƫng purposes and as needed to prevent or minimize page run-offs.

19. QuesƟon: aƩ_24, page 12

The solicitaƟon idenƟfies the PI and Deputy PI as required key personnel. May the offeror propose addiƟonal key personnel for evaluaƟon, and assign responsibiliƟes to those individuals that would otherwise fall under the roles of other requested key personnel?

19. Answer: Offerors may propose addiƟonal personnel as part of their proposed staffing approach; however, such individuals will not be considered or evaluated as Key Personnel.

The PI and Deputy PI and FuncƟonal Area Leads are the Key Personnel idenƟfied for evaluaƟon under the SolicitaƟon. AddiƟonal proposed personnel may not replace or assume the responsibiliƟes assigned by the SolicitaƟon to the PI, Deputy PI, or FuncƟonal Area Leads.

20. QuesƟon: aƩ_24, AƩachment D, page 52

The provided Biographical sketch form is outdated as of (10/31/2018), is the use of form revision "Modified from OMB No. 0925-0001 and 0925-0002 (Rev. 10/2021 Approved Through 09/30/2024)" acceptable?

20. Answer: Yes. The Government confirms that use of the revised Biographical Sketch form, “Modified from OMB No. 0925-0001 and 0925-0002 (Rev. 10/2021 Approved Through 09/30/2024),” is acceptable.

RFP- Questions and Answers

21. QuesƟon: Please clarify whether each offeror must propose and demonstrate the capability to perform the complete SOW covering all eight FuncƟonal Areas, or whether the Government will consider proposals covering only specified seven FuncƟonal Areas or combinaƟons of FuncƟonal Areas.

21. Answer: Offerors are required to propose and demonstrate the capability and capacity to perform the complete SOW across all eight FuncƟonal Areas. Proposals addressing fewer than all eight FuncƟonal Areas will not meet the SolicitaƟon requirements.

22. QuesƟon: If an offeror does not maintain an animal facility and proposes to subcontract

100% of Animal Studies to an AAALAC-accredited subcontractor, must the prime offeror itself nevertheless hold AAALAC accreditaƟon?

22. Answer: FuncƟonal Areas may not be subcontracted in its enƟrety, including the Animal Studies FuncƟonal Area. However, an offeror that does not maintain a funcƟoning animal facility may propose to subcontract the in-life porƟon of the Animal Studies FuncƟonal Area to an appropriately AAALAC-accredited subcontractor facility.

If the prime offeror does not maintain or operate the animal facility, the prime offeror itself is not required to hold AAALAC accreditaƟon. The facility at which the applicable animal studies are conducted must meet the accreditaƟon and other requirements specified in the SolicitaƟon.

The prime offeror must demonstrate its capability to perform and manage the overall requirements of the Animal Studies FuncƟonal Area and will remain responsible for performance of the requirements under the resulƟng contract.

23. QuesƟon: For an offeror that does not itself conduct GLP laboratory studies but proposes to perform all assignments directly supporƟng GLP toxicology studies through qualified GLP-compliant subcontract laboratories, may the subcontract laboratory's GLP compliance saƟsfy the Mandatory Requirement for GLP Compliance? If so, what documentaƟon must the prime provide for itself versus its proposed subcontractors?

23 Answer: The prime offeror must independently demonstrate that it meets the applicable Mandatory Requirement for GLP Compliance and possesses the technical and organizational capability to perform, manage, and oversee the GLP-related requirements of the SOW. The Mandatory Requirement for GLP Compliance may not be satisfied solely through the GLP compliance or capabilities of proposed subcontract laboratories.

24 QuesƟon: Please confirm whether each of the seven FuncƟonal Area Discipline Leads idenƟfied under Factor 4 - LogisƟcs and Handling, CharacterizaƟon, FormulaƟon, Biosample Analysis, Animal Studies, Omics, and In Vitro Assays - is considered Key Personnel and therefore must be an employee of the prime offeror.

RFP- Questions and Answers

24. Answer: Yes. The seven FuncƟonal Area Discipline Leads idenƟfied under Factor 4 are considered Key Personnel and, consistent with the SolicitaƟon requirements for Key Personnel, must be employees of the prime offeror.

25. QuesƟon: Please confirm that the minimum experience requirement across the seven listed areas may be saƟsfied collecƟvely by the offeror and its commiƩed subcontractors/team members, rather than requiring the prime offeror independently to demonstrate experience in all seven areas.

25 Answer: The prime offeror is required to independently demonstrate that it meets the minimum experience requirements across all seven areas idenƟfied in the SolicitaƟon.

Experience of subcontractors or other team members may not be used to saƟsfy the prime offeror’s minimum experience requirements.

26. QuesƟon: Will the Government provide labeled internal standards for all intended analytes for bioanalyƟcal work?

26. Answer: The Government will not provide labeled internal standards for all intended analytes for bioanalyƟcal work. Government-furnished property and materials are idenƟfied in the SolicitaƟon. Offerors are responsible for idenƟfying any addiƟonal materials, standards, supplies, or other consumables that will need to be purchased in support of the work.

27. QuesƟon: Will the bioanalyƟcal porƟon of Ɵssue studies be considered non-GLP?

27. Answer: The Government is unable to determine what is meant by “Ɵssue studies” in this quesƟon. In general, bioanalyƟcal work performed in support of animal studies requiring GLP compliance is expected to be conducted in accordance with applicable GLP requirements, with any appropriate excepƟons or deviaƟons documented. For in vitro studies, including microphysiological systems, the applicability of GLP requirements will be determined on a case-by-case basis based on the nature, intended use, and applicaƟon of the study and resulƟng data.

28. QuesƟon: Does the Government require any TK parameters in addiƟon to t1/2, Cmax, Tmax, AUClast, AUCinf, AUC%extrap, Rsq, Clast, Tlast,%Bioavailability, Cl, Vz, and Vss?

28. Answer: Offerors shall refer to the Chemistry SpecificaƟons available through the link provided in the SolicitaƟon for the applicable TK parameters and requirements. Specific TK parameters may vary based on the study design, objecƟves, test arƟcle, route of administraƟon, and intended use of the data and will be determined on a study-specific basis, as applicable.

29. QuesƟon: Would the matrices for bioanalyƟcal work include rodent CSF, urine or feces?

29. Answer: Specific biological matrices will depend on the requirements of each study and cannot be idenƟfied at this Ɵme. In general, offerors should anƟcipate that bioanalyƟcal work

RFP- Questions and Answers may involve a range of biological matrices, including, but not limited to, CSF, urine, feces, blood, plasma, serum, and Ɵssues, as applicable to the study design and objecƟves.

30.QuesƟon: A Summary of Related AcƟviƟes is included among the aƩached documents. We did not find verbiage staƟng the compleƟon of that document is required. Is this Summary of Related AcƟviƟes aƩachment required to be completed and submiƩed with the Proposal submission?

30. Answer: Yes. The Summary of Related AcƟviƟes should be completed and submiƩed with the proposal submission.

31. QuesƟon: We respecƞully request an extension of the due date of the proposal submission from Friday, September 11, 2026 to Wednesday, September 30, 2026.

31. Answer: The proposal submission due date is extended until September 14, 2026 by 4:00 pm.

Forma ng/Proposal Layout Ques ons

32. QuesƟon: AƩachment 24, page 5.

Please confirm if the Mandatory QualificaƟon Criteria can be included in an appendix and will not count towards the page limit

32. Answer: Yes. The Mandatory QualificaƟon Criteria may be included in an appendix and will not count against the applicable page limitaƟon. Offerors should refer to AƩachment 24 for the specific page limitaƟons applicable to each area of the proposal.

33. QuesƟon: Please confirm that a compliance matrix can be included and will not count against the page limit?

33. Answer: Yes. A compliance matrix may be included and will not count against the page limit. Offerors should refer to AƩachment 24 for the specific page limitaƟons applicable to each area of the proposal.

34. QuesƟon: Sol_75N94026R00002, page 97.

Please confirm that the Technical Proposal Cost summary will not count against the page limit?

34. Answer: Yes. The Technical Proposal Cost Summary will not count against the applicable page limitaƟon. Offerors should refer to AƩachment 24 for the specific page limitaƟons applicable to each area of the proposal.

35. QuesƟon: Please confirm that an execuƟve summary can be included and will not count against the page limit?

RFP- Questions and Answers

35. Answer: Yes. An ExecuƟve Summary may be included and will not count against the page limit. Offerors should refer to AƩachment 24 for the specific page limitaƟons applicable to each area of the proposal.

36. QuesƟon: AƩachment 24, page 12, 13, 19, 20, etc.

Please confirm all appendices including both named (such as biosketches, IT Security Plan, Health and Safety Plan, Health and Safety Chemical Hygiene Report, Quality Management) and unnamed – bibliography, technical back up documents, SOWs, etc. can be included as appendices and not counted against the page limit?

36. Answer: Offerors should refer to AƩachment 24 for the specific page limitaƟons applicable to each evaluaƟon factor. Materials submiƩed in support of an evaluaƟon factor are subject to the applicable page limitaƟon idenƟfied in AƩachment 24, unless specifically stated otherwise. Where AƩachment 24 does not specify a page limitaƟon, no page limitaƟon applies.

37. QuesƟon: Sol_75N94026R0000, page 103

Please confirm that the Other ConsideraƟons secƟon has no page limit.

37. Answer: Yes. There is no specified page limitaƟon for the Other ConsideraƟons secƟon.

38. QuesƟon: AƩachment 24, page 15.

Under EvaluaƟon Factor 3, Technical Approach and Sample Research Outlines it references that both the technical approach to accomplish the SOW and the SROs must be within the 200-page technical limit.

Would it be possible .to include the SROs in an appendix instead?

38. Answer: The Sample Research Outlines (SROs) are provided by the Government for offerors to use in developing and demonstraƟng their technical approach. The offeror’s technical response to the SROs is part of EvaluaƟon Factor 3 and is subject to the 200-page limit. Accordingly, the technical response to the SROs may not be provided as an appendix excluded from the page limitaƟon.

The Sample Research Outlines are also provided to build the business proposal. Also see AƩachment 24, Table 5 for AnƟcipated Research AcƟviƟes per year.

39. QuesƟon: Sol_75N94026R00002, page 104, AƩachment 24, page 13, 14, 16, 20

The RFP references both resumes and biosketches. Please confirm whether or not standard resumes would suffice, and if so, what the page limit would be. If the biosketch form is required, please confirm that the aƩachment D is correct as the expiraƟon date at the top is 2018.

39. Answer: The reference to resumes on page 104 of the SolicitaƟon was included in error.

Resumes are not required. Offerors shall submit biosketches for Key Personnel in accordance with the SolicitaƟon requirements.

RFP- Questions and Answers

Offerors shall submit biosketches using AƩachment D in accordance with the SolicitaƟon requirements. The current version of AƩachment D will be replaced with the revised form idenƟfied as “Modified from OMB No. 0925-0001 and 0925-0002 (Rev. 10/2021 Approved Through 09/30/2024).”

Criteria and Evalua on Factors Ques ons

40.QuesƟon: AƩachment 24, page 21-23

Factor 7 states: “(a) SolicitaƟon SubmiƩal Requirements: Submit a completed CPARS evaluaƟon for each project submiƩed under Factor 1, Experience.” Please confirm that Offerors can idenƟfy the contracts that have CPARS available in lieu of submiƫng the actual CPARS with their proposal.

40. Answer: “(a) SolicitaƟon SubmiƩal Requirements: Submit a completed CPARS evaluaƟon for each project submiƩed under Factor 1, Experience.” Please submit CPARS evaluaƟons as part of the proposal. Please do not reference CPARS evaluaƟons.

41. QuesƟon: AƩachments Package, page 6, DTT Chemistry SpecificaƟon Chapter 1. Personnel Requirements, page 2. The RFP references key personnel shall be employees of the contractor. Please confirm whether the non-technical key personnel, specifically the Lab Animal Veterinarian, must be an employee of the contractor.

41. Answer: The Lab Animal Veterinarian is not idenƟfied as Key Personnel under the SolicitaƟon. Therefore, the requirement that Key Personnel be employees of the contractor does not apply to the Lab Animal Veterinarian. The Lab Animal Veterinarian is not required to be an employee of the prime contractor and may be provided through a qualified part- Ɵme arrangement, consultant, or subcontractor, provided the individual meets all applicable requirements of the SolicitaƟon.

42. QuesƟon: AƩachment 24, pages 11 & 24

Factor 1 and Factor 7 define a recent relevant project as a contract that has been completed in the past five (5) years with services similar to those described in the aƩached statement of work. Please confirm that Offerors can provide current projects to meet the past performance requirements provided that the current projects have CPARS available to demonstrate the Offeror’s performance.

42. Answer: Yes. Offerors may submit current projects to meet the past performance requirements, provided the projects include services similar to those described in the Statement of Work and have CPARS available to demonstrate the offeror’s performance.

Business and Budget Ques ons

43. QuesƟon: Sol_75N94026R00002, page 24-25

The RFP indicates that the Small Business SubcontracƟng Plan should be submiƩed electronically using the HHS SCBX system. We have gone into the system and have not found any plans posted with this solicitaƟon number or Ɵtle. Please advise as to when the plan will be available in the system.

RFP- Questions and Answers

43. Answer: The SubcontracƟng Plan Summary for RFP 75N94026R00002 Chemistry Research for the Division of TranslaƟonal Toxicology (DTT) is now in SBCX.

hƩps://osdbu.hhs.gov/subcontracƟng/cca6b380-82c5-467f-96da-d32263fda6cb Chemistry Research for the Division of TranslaƟonal Toxicology (DTT) Control Code: 2026-NIH-0642

44. QuesƟon: Sol_75N94026R00002, page 13-14

Please indicate whether the government will provide level of effort esƟmates across the five labor classificaƟons to support equal evaluaƟon across proposed soluƟons, given the government’s emphasis on non-cost factors.

44. Answer: The Government will not provide level-of-effort esƟmates across the four labor classificaƟons. Offerors should consider the Sample Research Outlines and anƟcipated annual research acƟviƟes provided in the solicitaƟon when developing their proposed level of effort.

45. QuesƟon: AƩachment 24, AƩachment E

Please clarify where offerors should document any assumpƟons, adjustments, or notes related to changes made in AƩachment E, including whether such notes should be entered as comments within the Excel workbook or documented elsewhere in the file.

45. Answer: Offerors may document any assumpƟons, adjustments, or explanatory notes within the AƩachment E Excel workbook as notes, clearly idenƟfying the applicable item(s) to which the informaƟon relates.

46. QuesƟon: AƩachment E

Please confirm that offerors may modify the five (5) RFP labor classificaƟons in AƩachment E to align with the solicitaƟon.

Labor classificaƟons: Senior Research Professional, Research Professional, Professional, Technical Staff, and Support Staff

46. Answer: Offerors shall use the labor classificaƟons provided in AƩachment E. The labor classificaƟons in AƩachment E shall not be modified.

47. QuesƟon: AƩachment E

Please confirm that offerors may modify the Personnel Rates secƟon in AƩachment E to include all proposed personnel, and offerors will invoice actual direct labor rates upon award.

47. Answer: AƩachment E is for esƟmaƟng costs for summary of anƟcipated annual acƟviƟes. Offerors must not modify the Personnel Rates secƟon of AƩachment E to include individual proposed personnel and must use the four labor classificaƟons provided in

RFP- Questions and Answers

AƩachment E. Sample research Outlines are provided to inform both the anƟcipated annual costs for the business proposal, and the technical requirements of the contract.

A complete lisƟng of proposed personnel and applicable labor informaƟon shall be provided in AƩachment 13, as required by the SolicitaƟon. Upon award, the Contractor must invoice actual direct labor rates in accordance with the terms and condiƟons of the resulƟng contract.

48. QuesƟon: AƩachment E

Please confirm whether offerors may modify the indirect rate pools listed in AƩachment E to align with their established cost centers and federally negoƟated rate agreements. Please also advise whether the secƟon header “Indirect Rates” should be renamed “Indirect Rates, Fixed Fee, and Rate InflaƟon Factor.”

48. Answer: Offerors may adjust the indirect rate categories in AƩachment E, as necessary, to align with their established accounƟng pracƟces, cost centers, and applicable federally negoƟated indirect cost rate agreements. The Fixed Fee and InflaƟon EscalaƟon Factor shall remain separately idenƟfied and should not be incorporated into the indirect rate pools.

49. QuesƟon: AƩachment E

Please confirm whether offerors should price proposed personnel using their established compensaƟon structures, given that AƩachment E appears to include Federal GS levels for the labor classificaƟons.

49. Answer: Offerors should price proposed personnel using their established compensaƟon structures and provide the applicable rates for the four labor classificaƟons idenƟfied in AƩachment E. The Federal GS-equivalent references in AƩachment E are not intended to prescribe Federal GS levels or pay rates and will be removed from AƩachment E for clarity.

50. QuesƟon: AƩachment E

Please confirm whether offerors may use an escalaƟon rate other than the 3.0% currently reflected in AƩachment E, provided the escalaƟon rate and any related assumpƟons are clearly idenƟfied in the submission and consistent with their current policies and pracƟces.

50. Answer: Yes. Offerors may propose an escalaƟon rate other than the 3.0% reflected in AƩachment E, provided the proposed rate and related assumpƟons are clearly idenƟfied and are consistent with the offeror’s established policies and pracƟces.

51. QuesƟon: AƩachment E

Please confirm whether offerors may provide separate labor and ODC Excel tabs for each year that provide a breakdown of these costs. The current template only allows for the same 3.00% escalaƟon rate year over year, which would not permit Offeror’s to accurately propose labor costs that adhere to the cap. If separate labor and ODC excel tabs are allowed to be added, please confirm whether offerors should duplicate the applicable AƩachment E tabs to create separate tabs for each opƟon year.

RFP- Questions and Answers

51. Answer: Yes. Offerors may provide separate labor and ODC Excel tabs for each year to provide the applicable cost breakdown. Offerors may duplicate the applicable AƩachment E tabs to create separate tabs for the base period and each opƟon year. Any proposed escalaƟon rates and related assumpƟons should be clearly idenƟfied and consistent with the offeror’s established policies and pracƟces.

52. QuesƟon: AƩachment E

Please confirm whether offerors may modify the “Base Labor and Cost Details” tab and the “Opt. Labor and Cost Details” tab in AƩachment E to include all five RFP labor classificaƟons and provide proposed hours at the labor classificaƟon level only.

52. Answer: Offerors shall use the four labor classificaƟons provided in AƩachment E for the “Base Labor and Cost Details” and “Opt. Labor and Cost Details” tabs. These tabs shall not be modified to add or subsƟtute labor classificaƟons. Proposed hours shall be provided at the labor classificaƟon level using the four classificaƟons idenƟfied in AƩachment E.

53. QuesƟon: AƩachment E

Please confirm whether offerors should classify proposed personnel into one of the five labor classificaƟons referenced throughout the solicitaƟon and AƩachment E and explain the methodology used to classify personnel.

53. Answer: Offerors shall classify proposed personnel using the four (4) labor classificaƟons idenƟfied in AƩachment E. Offerors may provide an explanaƟon of the methodology used to classify proposed personnel within the four labor classificaƟons.

54. QuesƟon: AƩachment E

Please confirm whether offerors should submit three separate Excel files: one AƩachment 13 file for the Base through OpƟon Year 9 period, one AƩachment 13 file for OpƟon Year 10 (the 6-month extension) and one AƩachment E file covering the Base through OpƟon Year 10 period.

54. Answer: Offerors should submit two Excel files: (1) one AƩachment 13 file covering the Base Period, OpƟon Years 1 through 9, and the opƟonal 6-month extension period; and (2) one AƩachment E file covering all applicable periods. Offerors may expand AƩachment 13, adding tabs or columns as necessary, to include the addiƟonal columns needed to separately idenƟfy each period, including the opƟonal 6-month extension period. Please do not include a separate AƩachment 13 file for the 6-month extension period.

55. QuesƟon: Sol_75N94026R00002, page 83

Please confirm the wage determinaƟon offerors should use for cosƟng non-exempt Service Contract Labor Standards (SCLS) applicable personnel (e.g., administraƟve assistants, data entry operators, material handling laborers, secretaries, laboratory/engineering/environmental technicians).

55. Answer: Please use this link:

RFP- Questions and Answers

Wage DeterminaƟons | SAM.gov Go to ‘Service Contracts- Wage rates for service employees’

56. QuesƟon: AƩachment E

Please confirm that the anƟcipated number of tasks per year is one (1) under the OpƟonal Studies for the Biosample Analysis (BSA) because the solicitaƟon and aƩachment E have differing amounts.

56. Answer: The discrepancy in AƩachment E was an oversight. Offerors should use the anƟcipated number of tasks for OpƟonal Studies for Biosample Analysis (BSA) idenƟfied in the SolicitaƟon.

57. QuesƟon: AƩachment 24

"Offerors shall prepare a separate cost proposal for the opƟonal 6-month extension based on the level of effort anƟcipated in OpƟon Year 9 of the base contract." Please confirm that the intenƟon of this statement is that the Offerors should provide a separate cost breakdown for the 6-month opƟon period by adding this period to the budget templates (AƩachment 13 & AƩachment E). Please confirm that the government does not require a separate cost proposal just for the 6-month OpƟon period.

57. Answer: The statement, “Offerors shall prepare a separate cost proposal for the opƟonal 6-month extension based on the level of effort anƟcipated in OpƟon Year 9 of the base contract,” was included in error and will be removed. Offerors should include the cost breakdown for the opƟonal 6-month extension period in the applicable budget templates (separate TAB), AƩachments 13 and E. Please do not provide a separate standalone cost proposal for the 6-month extension period.

Contractual Ques ons

58. QuesƟon: Sol_75N94026R00002, page 13

Please confirm the start date of the period of performance is January 18, 2027, while the current contract ends on January 31, 2027.

58. Answer: The earliest anƟcipated period of performance start date is January 18, 2027.

This date is tentaƟve and subject to change based on compleƟon of the acquisiƟon and award process. The final period of performance start date will be established at the Ɵme of contract award.

59. QuesƟon: Sol_75N94026R00002, page 119

Given that the contract type is designated as Cost Plus Fixed Fee. Can the government please confirm what porƟon of the fee is fixed or a guaranteed minimum fee and what porƟon is dependent on level of effort? Please also confirm how Offerors should present the fee in AƩachments E and 13.

59. Answer: The fixed fee is paid in direct raƟo to the level of effort expended. The percent of fee paid shall be equal to the percent of total effort expended.

RFP- Questions and Answers

Fixed Fee should be included as a separate line [Proposed Fee/Profit and Fixed Fee(x%)] within the excel budget spreadsheets.

Addi onal amendment item:

In Attachment 24, page 17, Factor 4, paragraph (b)(i), Professional/Key Personnel, was amended to add the following:

Other Professional Personnel (e.g., Quality Assurance Officer, Health and Safety Officer, Veterinarian:

Appropriateness of the education, training, experience, and competency of the proposed personnel to conduct activities as specified in the Chemistry specifications; effort on, and availability to projects;

include those of any proposed subcontractors/consultants.