RFP 75N98026R00034_Vendor Questions.xlsx
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- Solicitation number
- 75N98026R00034
About this file
This file is a Questions and Answers document addressing vendor inquiries regarding RFP 75N98026R00034 for Clinical Research Support and Collaboration for NHGRI Protocols.
The Q&A clarifies the scope of contractor responsibilities, which include comprehensive operational support across all Task Orders without additional effort estimates beyond stated workload assumptions. The contractor will assume responsibility for source-data entry, regulatory-file maintenance, ClinicalTrials.gov submissions, safety assessments, and database development and maintenance, with Government staff limited to requesting work, establishing priorities, and providing oversight. For Task Order 1, a designated licensed physician with pharmacovigilance and clinical trial safety experience is required for medical monitoring, with serious adverse event reviews due within one business day; no evening, weekend, or holiday on-call coverage is required. Task Order 2 assumes approximately 16 monitoring visits with six estimated for on-site performance in Bethesda, two to three business days per review (excluding travel and follow-up effort), and focus on specifically quantified regulatory submissions rather than routine maintenance of all 52 active IND/IDE applications. Task Order 3 addresses DSMB Executive Secretary support with no prescribed hourly estimates, though meetings typically require no more than two hours. The document specifies that resumes and appendices do not count toward the 25-page technical proposal limit, offerors may propose labor categories and staffing levels appropriate to their approaches, and three separate price quotations are required for the three Task Orders within a single Technical Quotation. The document also clarifies that Task Orders 2 and 3 are for evaluation only and will not be awarded concurrently with the parent IDIQ, the contractor must provide the clinical database environment for Task Order 1, no international sites require monitoring, and an approximately two-month transition period is anticipated with incumbent contractor support.
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Sheet1
| Clinical Research Support and Collaboration for NHGRI Protocols | |||
| RFP 75N98026R00034 - VENDOR QUESTIONS | |||
| Question No. | Reference | Vendor Question | Government Response |
| 1 | Parent SOW, Task Area 1, p 4–5; TO2 s3.1, p 17–18 | Please clarify whether TO2’s workload assumptions include all program-level responsibilities described in the parent SOW, including SOP maintenance, CAPA oversight, audit scheduling, staff training, regulatory-file maintenance, ClinicalTrials.gov support, and policy liaison activities, or whether offerors should estimate additional effort for these functions beyond the stated monitoring visits/reviews. | Yes, TO2 workload assumptions includes all program level responsibilities described in the parent SOW including SOP maintenance, CAPA oversight, audit scheduling, staff training, regulatory-file maintenance, ClinicalTrials.gov support, and policy liaison activities. Offerors do not need to estimate additional effort for these functions beyond the stated monitoring visits/reviews. |
| 2 | Parent SOW, TA 1, p 4–5; TO1 sec3–5, p 11–15; TO2 sec3–6, p 17–20. | What functions will remain with Government staff or other support providers, and which will be the contractor’s responsibility? Please clarify ownership of source-data entry, regulatory-file maintenance, ClinicalTrials.gov submissions, safety assessments, and database development and maintenance. | The intent is for the contractor to provide comprehensive operational support for all requested activities. The Government’s role will be to request and authorize work, establish priorities, and provide contract oversight and acceptance of deliverables. Government staff are not expected to perform the day-to-day work. Therefore, the contractor’s responsibilities will include source-data entry, regulatory-file maintenance, ClinicalTrials.gov submissions, safety assessments, and database development and maintenance. |
| 3 | TO2 sec4.1, p. 18 | Does the assumed portfolio of approximately 40 active INDs and 12 active IDEs require ongoing contractor maintenance of all applications, or support limited to the enumerated submissions and reviews? Please clarify the workload offerors should assume for annual reporting, safety reporting, outstanding FDA commitments, and application maintenance beyond the listed quantities. | The support focuses on the enumerated submissions and reviews, though can also involve the overall portfolio as needs require. |
| 4 | Attachment 2, Task Order 1, sec 4.3 | Task Order 1 requires ongoing medical monitoring availability throughout the 12-month period of performance, including adverse-event assessment, safety consultation, and regulatory reporting support. Please clarify whether the Government requires a designated licensed physician to perform medical monitoring, including any applicable medical specialty, licensure, or clinical research experience requirements. | |
| Yes, the Government does require a designated licensed physician or physician-led medical monitoring under Task Order 1 for Protocol 20-HG-0034, “A Multi-Cohort Phase 2 Dose-Escalation Study of MK-7075 (Miransertib) in Proteus Syndrome.” There is not a need for a specific medical specialty, however, they should be licensed and have experience in pharmacovigilance and clinical trial safety, safety reporting for IND, IDE, and post-market drugs. | |||
| 5 | Attachment 2, Task Order 1, sec 4.3 | For proposal and staffing purposes, what coverage hours, response times for urgent safety concerns and serious adverse event reviews, and backup coverage should offerors assume for the licensed physician medical monitor? Please clarify whether evening, weekend, and holiday on-call coverage is required. | Urgent issues requiring medical judgment shall be escalated to the appropriate investigator or designated medical professional. Serious Adverse Event (SAE) reports from the clinical site are to be reviewed as soon as possible and within one business day of receipt. Support will include review of SAEs provided by the site, any queries needed for clarification, and writing of SAE narratives. No evening, weekend, and holiday on-call coverage is not required. |
| 6 | TO1 sec 3.2 and 4.3 | What reconciliation activities should offerors assume among the clinical database, medical-monitor assessments, and IND safety-reporting records, and which party will maintain the authoritative safety record? | The contractor shall provide personnel with clinical research monitoring and quality assurance experience appropriate to the assigned responsibilities. The contractor shall maintain monitoring availability throughout the 12-month period of performance, including coordination of adverse-event review, safety consultation, and regulatory reporting support. |
| 7 | TO1 sec 5.1, PDF p. 15; TO2 sec 5, PDF p. 19 | Will existing DSMB report templates, statistical programs, and the Manual of Operations be provided, and what separation of personnel or data access is required between study operations, statistical reporting, and Executive Secretary functions? | The Government anticipates making existing DSMB report templates and the Manual of Operations available to the contractor and transferring existing statistical programs during transition. The transition plan will identify the available materials and arrangements for their transfer. Offerors should describe how their proposed staffing and data-access arrangements will protect confidentiality and maintain any required study blinding across study operations, statistical reporting, and Executive Secretary functions. Whether separate personnel or specific access restrictions are required remains to be confirmed against the applicable study and DSMB governing documents. Any such requirements will be clarified for offerors before a Task Order proposal submission. |
| 8 | TO2 sec 3.1, PDF p 17–1 | Do the two-to-three-business-day estimates per monitoring review include follow-up through findings/CAPA closure, and what assumption should offerors use to reconcile approximately 16 reviews with 10–15 monitoring reports? | The estimated two to three business days per review exclude travel time and exclude follow-up through findings/CAPA closure. Offerors shall identify travel costs and follow-up effort separately in their pricing. For the purpose of estimates, it might be assumed that approximately 6 may require on-site review, but this is subject to change based on protocol changes, new and evolving NIH and NHGRI requirements, and other factors. |
| 9 | SOW, Task Area 1: Protocol Monitoring and Data Management Support Services, Scope Paragraph 1, Page 3 of 10 | Will there be any international sites that will require monitoring? | No, there are no international sites that will require monitoring. |
| 10 | SOW, SCOPE, Page 1 of10 | Pharmacovigilance services are required. Is there a pharmacovigilance system currently in use that NIH wants to continue to use? | No, there is not a pharmacovigilance system currently in use that the NIH wants to continue to use. |
| 11 | Attachment 3, Criterion 1, page 1 | Criterion 1 states that "offeror shall identify personnel proposed in accordance with solicitation requirements". There are no labor qualifications, labor categories or key personnel identified. Can offerors provide a staffing plan that demonstrates the mix of personnel, education, professional qualifications and relevant technical experience for all roles to meet this requirement? Also as no key personnel are identified, is it at the Offeror's discretion as to what resume(s) are provided? Also please confirm resumes do not count against the 25 page limit? | Yes, offerors are encouraged to provide a staffing plan that demonstrates the mix of personnel, education, professional qualifications and relevant technical experience for all roles to meet this requirement. Because the solicitation does not designate key personnel or prescribe specific labor categories, offerors may determine which proposed personnel’s resumes to submit to substantiate their staffing approach. Resumes should support the qualifications presented for personnel responsible for major technical and management functions. |
Resumes submitted as a separate appendix will not count toward the 25-page technical proposal limit.
| 12 | Attachment 3, Criterion 1 p.1; RFQ, Key Personnel p.6 | Can the government provide an estimated level of effort which includes the current positions and level of effort currently being performed on this contract. | The Government will not provide current incumbent positions or historical levels of effort. Offerors shall develop and justify their proposed labor categories, staffing levels, and labor hours based on the requirements and workload assumptions in the parent SOW and individual task orders. |
| 13 | Attachment 2, TO2 §1 p.1; TO3 §1 p.1; Attachment 3 p.1 | Task Orders 2 and 3 are designated for evaluation only and will not be awarded with the parent IDIQ. Please confirm whether offerors must provide separate complete technical and price quotations for all three sample task orders and explain how the three task-order prices will be incorporated into the total evaluated price. These monitoring visits are inclusive of, not in addition to, the parent SOW allowance of up to three one-day Bethesda visits. | Please address Task Orders 1, 2, and 3 within a single Technical Quotation Three separate Technical Quotations are not required; however, 3 separate price quotes should be submitted. |
| 14 | Attachment 2, TO1 §3.1 pp.1–2; Parent SOW, Place of Performance and Travel p.3 | Task Order 1 requires two monitoring reviews/visits and indicates the Government will determine whether they are remote or on-site. For a common pricing basis, please confirm how many of the two reviews should be assumed on-site and whether the parent SOW assumption of up to three one-day Bethesda visits is in addition to, or inclusive of, these monitoring reviews. | Task Order 1 anticipates monitoring reviews/visits approximately six months apart, with substantially less data to review than how the study currently stands. For a common pricing basis, offerors should assume both reviews will be conducted on-site in Bethesda. |
| 15 | Attachment 2, TO2 §3.1 pp.1–2 | Task Order 2 assumes 16 monitoring visits/reviews but states that an undetermined number will require on-site performance. Please specify the number of on-site versus remote monitoring visits to be used for consistent proposal pricing, including whether the 2–3 business days per review includes travel time. | The estimated two to three business days per review exclude travel time and exclude follow-up through findings/CAPA closure. Offerors shall identify travel costs and follow-up effort separately in their pricing. For the purpose of estimates, it might be assumed that approximately 6 may require on-site review, but this is subject to change based on protocol changes, new and evolving NIH and NHGRI requirements, and other factors. |
| 16 | Attachment 2, TO2 §4, pp.2–3; Parent SOW, Task Area 2 pp.5–7 | For the Task Order 2 regulatory support assumptions of approximately 40 active INDs and 12 active IDEs, please clarify whether all 52 files require routine maintenance and review during the 12-month evaluation period, or whether offerors should price only the specifically quantified reports, submissions, and gap analyses listed in §4. | Offerors should focus on the specfically quantified information, though maintenance of other items may also be required. |
| 17 | Attachment 2, TO2 §5 p.3; Parent SOW, Task Area 3 pp.7–8 | For evaluation pricing of DSMB support, please confirm the assumed level of effort for the Executive Secretary and the anticipated preparation, attendance, and post-meeting reporting hours per quarterly or ad hoc DSMB meeting. Should offerors include compensation or reimbursement for external DSMB members? | Offerors shall propose the full level of effort necessary to provide Executive Secretary and DSMB meeting support, including meeting coordination, preparation and distribution of materials, attendance, minutes and report preparation, action-item tracking, and post-meeting follow-up. No fixed number of hours per meeting is prescribed however, these meetings have taken no more than 2 hours. For quarterly and ad hoc meetings, offerors shall separately identify their assumed preparation, attendance, and post-meeting reporting hours and explain the basis for those estimates. DSMB compensation should not be included. |
| 18 | Attachment 3, Criterion 3: Offeror Experience, pp. 2–3; Criterion 1: Personnel, p. 1 | For Criterion 3 (Offeror Experience), will the Government consider relevant clinical research experience acquired by proposed key personnel while employed by other organizations or performing on contracts not held by the offeror as evidence of the offeror’s experience? If so, please clarify how such experience should be identified and documented, and whether it will receive the same consideration as experience performed under contracts held by the offeror. | Criterion 3 evaluates the offeror company’s relevant experience. Experience acquired by proposed personnel while employed by other organizations does not qualify as the offeror’s experience under Criterion 3. Such experience may be documented in personnel resumes for evaluation under Criterion 1, Personnel. |
| 19 | RFQ §(iv), p. 2 (small-business set-aside); Attachment 3, Criterion 4: Past Performance, p. 3 | Because this acquisition is set aside for small businesses and Criterion 4 requests no more than three recent and relevant contract references, will the Government require a minimum number of the references to reflect contracts performed by the prime offeror itself? Alternatively, may the offeror include relevant past performance of proposed subcontractors or teaming partners among the three references, and, if so, how will the Government evaluate those references relative to the prime offeror’s own performance? | No minimum number of prime-offeror references is required. Offerors may include proposed subcontractor or teaming-partner references within the three-reference limit. Identify the performing entity and its proposed role. All references will be evaluated for recency, relevance, and performance quality in relation to that entity’s proposed responsibilities. |
| 20 | NHGRI Clinical Research Support RFQ - Addendum to RFO 52.212-4, Paragraph (3), Key Personnel, page 6 | The RFQ states that specified Key Personnel will be considered essential to contract performance but identifies the individuals as “[To be completed in the award document].” Please clarify which positions or functional roles the Government intends to designate as Key Personnel under the resulting contract. | Offerors shall identify proposed personnel and demonstrate their qualifications, roles, availability, and commitment in accordance with Criterion 1. |
| 21 | Att_01 - PackagingandDeliveryofProposalsUsewithNIHeCPSwebsite - II. Formatting and Page Limitations, B. Page limitations, #3, page 2 | The instructions state"each resume shall not exceed 5 pages" however does not state for whom resumes need to be provided. Please clarify whether offerors are expected to identify and provide resumes for all personnel proposed to perform Task Orders 1–3, only proposed Key Personnel, or only personnel filling principal/senior technical roles. | Offerors shall identify and provide resumes for all personnel proposed supporting Task Orders 1–3. |
| 22 | Att_03 - Technical Evaluation Criteria - Criterion 1: Personnel, Paragraph 3, Bullet #8, page 1 | Criterion 1 provides for evaluation of the availability and commitment of proposed personnel. Please clarify what documentation, if any, the Government expects offerors to provide to substantiate personnel availability and commitment, such as letters of commitment, signed availability statements, or other documentation. | Offerors shall provide sufficient information for the Government to evaluate proposed personnel’s availability and commitment, including their anticipated availability and planned participation in the proposed work. |
| 23 | Att_01 - PackagingandDeliveryofProposalsUsewithNIHeCPSwebsite; Att_02 - IDIQ SOW_parent_Tos - Volume II - Price Quotation, Task Orders 1 and 2. page 2 | Attachment 1 requires offerors to provide estimated labor hours by labor category for each Task Order. Task Orders 1 and 2 provide workload assumptions but do not provide labor-hour assumptions for all required activities. Please confirm whether offerors should independently develop the proposed labor-hour level of effort for these activities or whether the Government intends to provide standardized labor-hour assumptions for proposal and evaluation purposes. | Offerors shall independently develop and justify proposed labor hours by labor category for each task order, using the stated requirements and workload assumptions. Where specific labor-hour assumptions are provided, use those assumptions. For other activities, clearly document the basis for the proposed level of effort and ensure consistency between the Technical and Price Quotations. |
| 24 | Att_02 - IDIQ SOW_parent_Tos - Task Order 2, Section 3.1, Evaluation/Proposal Assumptions, page 18 | Task Order 2 states that an undetermined number of the approximately 16 monitoring visits/reviews may require on-site performance at the NIH campus in Bethesda. Because offerors are required to submit a separate price for Task Order 2, please provide the common proposal assumption offerors should use regarding the number of on-site versus remote monitoring visits and associated travel for evaluation and pricing purposes. | The estimated two to three business days per review exclude travel time and exclude follow-up through findings/CAPA closure. Offerors shall identify travel costs and follow-up effort separately in their pricing. |
| 25 | Att_02 - IDIQ SOW_parent_Tos - Task Order 1, Section 3.2, Data Management, page 13 | For proposal purposes, should offerors assume responsibility for developing and configuring the Continued Treatment Period clinical study database? | Yes. |
| 26 | Att_01 - PackagingandDeliveryofProposalsUsewithNIHeCPSwebsite - II. Formatting and Page Limitations, B. Page limitations, #2, b., page 2 | Please clarify what information the Government expects offerors to include in the "IT section" and confirm that an Information Security section submitted as an appendix falls outside the 25-page count. | The IT section should describe proposed systems and applications, the hosting approach, and how the offeror will meet applicable IT, information security, and privacy requirements in the solicitation. |
The Information Security section is submitted as an appendix and excluded from the page count.
| 27 | Att_01 - PackagingandDeliveryofProposalsUsewithNIHeCPSwebsite - II. Formatting and Page Limitations, C. Content/Format of Response, Volume I - Technical Quotation, #1, page 2 | The instructions do not include required sections within the Technical Quote. Can the Government please confirm whether offerors may organize the Technical Proposal in the structure they believe best demonstrates their approach to the parent SOW and Task Orders, or whether the Government intends to provide a required response structure? | Yes. Offerors may organize the Technical Quotation in the manner that best demonstrates their response to the parent SOW and Task Orders 1–3. Clearly identify the information addressing each evaluation criterion in Attachment 3. Follow Attachment 1’s submission, cover-page, formatting, and page-limit requirements. | |
| 28 | Att_01 - PackagingandDeliveryofProposalsUsewithNIHeCPSwebsite - II. Formatting and Page Limitations, C. Content/Format of Response, Volume II - Price Quotation, Paragraph 3, page 3 | Can the Government please confirm that only separate cost proposals are required for each task order, not a full proposals with Technical Quote? | Yes. Task Orders 1, 2, and 3 will be addressed within a single Technical Quotation and three separate 3 separate price quotes should be submitted. | |
| 29 | Att_01 - PackagingandDeliveryofProposalsUsewithNIHeCPSwebsite - II. Formatting and Page Limitations, C. Content/Format of Response, Volume II - Price Quotation, Paragraph 1, page 2 | Can the Government please clarify whether the pricing should be provided via an Excel spreadsheet with formulas or in Word/PDF document format with the narrative? | Submit pricing and supporting narratives in one searchable PDF Business/Price Quotation, with separate pricing identified for each task order. An Excel spreadsheet is not needed. | |
| 30 | RFQ | The solicitation requires offerors to identify proposed personnel and demonstrate their qualifications, relevant experience, assigned roles, and availability. Please confirm that offerors have discretion to propose labor categories and staffing levels appropriate to their technical approaches. | Yes. Offerors may propose labor categories and staffing levels appropriate to their technical approaches and the stated requirements and workload assumptions. Explain how the proposed staffing supports performance and ensure consistency between the Technical and Price Quotations. | |
| 31 | RFQ | The RFQ identifies the contemplated task orders as Time-and-Materials (T&M) under Section 13. However, the IDIQ Task Order Procedures on page 8 state that task orders may be issued on either a Firm-Fixed-Price (FFP) or T&M basis. Please clarify the intended contract type for Task Orders 1, 2, and 3. | Both Time and Materials (T&M) and Fixed Price task orders may be issued under this contract. At this time only a T&M task order will be issued with the award of the contract. | |
| 32 | Att_02 – Statement of Work (SOW) | The Statements of Work for Task Orders 2 and 3 indicate that these task orders are included for evaluation purposes and will not be awarded concurrently with the parent IDIQ contract. Please clarify whether offerors are required to submit fully developed technical approaches, staffing plans, and separately priced cost proposals for all three task orders. Additionally, please confirm whether the evaluated prices for Task Orders 1, 2, and 3 will be combined to establish the Total Evaluated Price for contract award purposes, notwithstanding that Task Orders 2 and 3 are not guaranteed awards. | Offerors shall address the technical approach and staffing for Task Orders 1–3 within one Technical Quotation and provide separate pricing and supporting narratives for each task order within the Business/Price Quotation. The Government will evaluate each task order’s proposed price separately. | |
| 33 | Att_02 – Statement of Work (SOW) | Task Order 2 identifies approximately 40 active INDs and 12 active IDEs, while specifying 12 IND Annual Reports, 10 Safety Reports/MedWatch submissions, 2 routine regulatory submissions, 1 new IND and/or IDE submission, and 2 gap analyses for pricing purposes. Please clarify whether the contractor is expected to assume ongoing regulatory oversight and maintenance responsibility for all 52 active applications, or whether contractor support will be limited to specific applications and activities assigned by NHGRI. | Offerors should focus on the specfically quantified information, though maintenance of other items may also be required. | |
| 34 | Att_02 – Statement of Work (SOW) | The SOW permits the use of Government-approved systems such as REDCap and CTDB and indicates that applications may be hosted in Government-provided or contractor-provided environments. For Task Order 1, please confirm that NHGRI will provide the clinical database environment, associated software licenses, system administration, and hosting infrastructure. | No, NHGRI will not provide the clinical database environment therefore, there will not be associated software licenses, system administration or hosting infrastructure. | |
| 35 | Att_02 – Statement of Work (SOW) | The SOW indicates that work will primarily be performed at the contractor's site, with periodic on-site support at NHGRI. Task Order 1 assumes two monitoring visits annually, while Task Order 2 assumes approximately 16 monitoring visits, with the number requiring on-site performance undetermined. Please clarify whether offerors should assume that the monitoring visits under Task Orders 1 and 2 will be performed remotely unless otherwise specified, or whether the Government expects offerors to include an assumed number of on-site visits at NHGRI for consistent pricing evaluation. Additionally, please confirm whether the three annual one-day visits specified in the parent SOW for Task Order 1 are separate from, or inclusive of, its two anticipated protocol monitoring visits at NHGRI. | The estimated two to three business days per review exclude travel time and exclude follow-up through findings/CAPA closure. Offerors shall identify travel costs and follow-up effort separately in their pricing. | |
| 36 | Att_03, Criterion 3 | Offeror Experience. Please clarify whether Criterion 3 experience examples are subject to the same three-contract limitation established under Criterion 4 – Past Performance, or whether offerors may provide additional relevant project examples under Criterion 3. | The three-contract limit applies only to Criterion 4, Past Performance. Criterion 3, Offeror Experience, has no maximum number of examples. Offerors may provide additional relevant examples within the Technical Quotation’s 25-page limit. | |
| 37 | Att_03, Criterion 3 | Personnel, requires offerors to identify proposed personnel and demonstrate their qualifications, roles, availability, and commitment. However, the RFQ does not identify specific Key Personnel positions or minimum staffing requirements. Please identify the positions, if any, that the Government requires offerors to designate as Key Personnel, and clarify whether named individuals and resumes are required for every proposed labor category or only for designated Key Personnel. | The Government has not prescribed specific Key Personnel positions or minimum staffing levels. Offerors shall propose staffing appropriate to their technical approaches and the stated workload. Named individuals and resumes are required for all proposed personnel. | |
| 38 | Att_02, Parent SOW and Task Order 1; Ref. Att_03 Criterion 2 – Technical and Management Approach | The Parent SOW, Transition and Startup, requires development of a transition plan within ten calendar days of contract award and continuity of services during transition. Task Order 1, Section 6, identifies multiple categories of incumbent documentation and study information requiring transfer. Please clarify the anticipated transition-in period, whether the incumbent contractor will be required to provide transition assistance, and whether the Government expects the successor contractor to assume full operational responsibility on January 1, 2027, or following completion of an authorized transition period. | The Government anticipates an approximately two-month transition-in period, during which the incumbent contractor will provide transition assistance. The successor contractor shall develop the transition plan in coordination with the COR within ten calendar days after contract award and coordinate the transfer of documentation, data, and ongoing activities to ensure continuity of services. The successor is expected to assume full operational responsibility upon completion of the authorized transition period, rather than automatically on January 1, 2027. | |
| 39 | Attachment 1, Section II.B.1 and Section II.C, Volume I, Item 2, Page 2; Attachment 3, Criteria 1 through 3, Page Limitations; Volume I Technical Quotation | Section II.B.1 limits the Technical proposal to 25 pages, and Section II.C, Volume I, Item 2 limits the technical approach to 25 pages. Please confirm whether the 25-page limit applies to the entire Technical Quotation, including the responses to Task Orders 1, 2, and 3 and Criterion 1 (Personnel), Criterion 2 (Technical and Management Approach), and Criterion 3 (Offeror Experience), or to the technical approach narrative alone. | The 25-page limit applies to the entire Technical Quotation, including responses to Task Orders 1–3 and Criteria 1–3, rather than only the technical approach narrative. The exclusions in Attachment 1, Section II.B.2, including resumes and appendices, remain applicable. Past performance information under Criterion 4 shall be submitted with the Business/Price Quotation and does not count toward the technical page limit. | |
| 40 | Attachment 1, Section II.A.4 and Section II.C, Volume I, Item 2, Page 2, Formatting for Proposals; Volume I Technical Quotation | Section II.A.4 permits 10 to 12 point font, and Section II.C, Volume I, Item 2 requires 11 or 12 point Arial or Times New Roman for the technical approach. Please confirm whether offerors may use 10 point font within tables, figures, and graphics in the Technical Quotation. | Yes. | |
| 41 | Attachment 2, Applications, Systems, and Hosting Environment, Page 3; Attachment 2, Task Order 1, Section 3.2; Attachment 6, HHSAR 352.239-76, Pages 27 through 34, Applications, Systems, and Hosting Environment; Data Management | Please confirm whether the Government will provide the REDCap or CTDB instance, hosted within an NIH environment, for the Task Order 1 Continued Treatment Period database. If offerors should assume a contractor-hosted environment, please confirm that the Assessment and Authorization package requirements of HHSAR 352.239-76 apply for pricing purposes. | For proposal pricing, offerors should not assume a contractor-hosted environment or include a separate Assessment and Authorization package for contractor hosting. | |
| 42 | Attachment 2, Transition Plans, Section A, Page 9; Attachment 2, Task Order 1, Section 6; RFQ, Cost/Price Evaluation, Page 4, Transition and Startup; Cost/Price Evaluation | To support the price evaluation described on Page 4 of the RFQ, please provide the historical labor hours or staffing levels by Task Area under the predecessor contract and the current number of contractor personnel supporting these requirements. | The Government will not provide historical labor hours, staffing levels by Task Area, or current incumbent personnel counts. Offerors shall develop and justify their proposed staffing and labor hours using the requirements and workload assumptions in the parent SOW and individual task orders. | |
| 43 | Attachment 2, Task Order 2, Section 3.1, Evaluation/Proposal Assumptions, third assumption, Protocol Monitoring; Evaluation/Proposal Assumptions | The assumption states that “approximately an undetermined amount of monitoring visits will require onsite performance.” Please provide the number of on-site monitoring visits offerors should assme for pricing and evaluation. | The estimated two to three business days per review exclude travel time and exclude follow-up through findings/CAPA closure. Offerors shall identify travel costs and follow-up effort separately in their pricing. | |
| 44 | Attachment 2, Place of Performance and Travel, Page 3; Attachment 2, Task Order 1, Sections 3.1 and 7, Place of Performance and Travel; Protocol Monitoring | Please confirm that the three one-day trips per IDIQ year in the parent SOW pricing assumption cover any on-site Task Order 1 monitoring reviews, or whether offerors should price on-site monitoring visits separately. | The estimated two to three business days per review exclude travel time and exclude follow-up through findings/CAPA closure. Offerors shall identify travel costs and follow-up effort separately in their pricing. | |
| 45 | Attachment 1, Section II.C, Volume II Price Quotation, Pages 2 and 3; Attachment 1, Section I.B.4, Page 1, Volume II Price Quotation; Creating and Naming Files | Task Orders 2 and 3 span two IDIQ contract years (March 1, 2027 through February 28, 2028, and May 1, 2027 through April 30, 2028). Please confirm whether offerors should apply Year 1 and Year 2 loaded rates to the months falling in each contract year. Please also confirm whether the Government provides a pricing template, since Attachment 1, Section I.B.4 references an “Excel Workbook.” | Yes. Apply the loaded hourly rates for the IDIQ contract year in which the work will be performed. For TO2 and TO3, separately identify the hours and costs attributable to each applicable contract year. Submit pricing and supporting narratives in one searchable PDF Business/Price Quotation, with separate pricing identified for each task order. An Excel spreadsheet is not needed. | |
| 46 | RFQ, Section (15)(iv), Page 2; RFQ clause list, Pages 4 and 5; Attachment 3, Criteria 3 and 4, Small Business Set-Aside; Criterion 3 Offeror Experience; Criterion 4 Past Performance | Please confirm whether the Government will evaluate the experience and past performance of proposed subcontractors and joint venture members under Criteria 3 and 4, and whether RFO 52.219-14, Limitations on Subcontracting, applies to this small business set-aside. | The Government will consider relevant experience and past performance of proposed subcontractors and joint venture members under Criteria 3 and 4, respectively. Identify the entity that performed the referenced work, its responsibilities, and its proposed role. The Government will consider relevance to that entity’s proposed responsibilities. Criterion 4 remains limited to three references total. RFO 52.219-14 does apply and the RFQ has been updated to add this. | |
| 47 | Attachment 4, Section 1, Quarterly Progress Reports, Page 1, Quarterly Progress Reports | The Quarterly Progress Report requirement refers to activities “conducted by the NHGRI Biorepository.” Please confirm that the quarterly reports cover activities performed under this Clinical Research Support and Collaboration IDIQ and its task orders. | Confirmed. Quarterly Progress Reports shall cover activities performed under the Clinical Research Support and Collaboration IDIQ and its task orders. | |
| 48 | Att. 1, §I.B.3 (p. 1) and §II.B.4 (p. 2); Att. 3, Criterion 3 (p. 2) and Criterion 4 (p. 3) | |||
| §II.B.4 | Please confirm whether Criterion 3 (Offeror Experience) goes in the Technical Volume and counts toward the 25 pages. Please state whether Criterion 3 has a maximum number of examples. | Yes. Criterion 3 goes in the Technical volume and does count towards the 25 pages. There are no maximum number of examples. | ||
| 49 | Att. 1, §I.B.3 (p. 1) and §II.B.4 (p. 2); Att. 3, Criterion 3 (p. 2) and Criterion 4 (p. 3) | |||
| §II.B.4 | Please confirm whether Criterion 4 (Past Performance) goes only in the Business Proposal. | Yes. |
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