W81XWH21R0078 Questions Tracker 7JAN2021.xlsx
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- Solicitation number
- W81XWH21R0078
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Department of the Army Medical Command
About this file
This document is a questions and answers tracker related to a solicitation for regulated activities support services. The solicitation is seeking proposals for an indefinite delivery/indefinite quantity contract to provide regulatory consultation, oversight, and contract research organization support services to the U.S. Army Medical Research and Development Command Office of Regulated Activities. Key details include that the incumbent contractor is currently providing full CRO services and utilizing MRDC ORA standard operating procedures, the initial task order is for the existing effort being handled by ORA and the current contractor team of approximately 39 full-time equivalents, and proposals are due by January 7, 2021 with an award date of April 1, 2021. The solicitation involves firms providing services such as regulatory science, clinical trial management, and investigational product management.
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Sheet1
| W81XWH21R0078 Questions | 1/7/21 | |||||
| Number | RFP Document | RFP Reference/Section | Page No. | Question | Answer | Resulting Amendment |
| 1 | General | Is one of the Government’s intent for this IDIQ contract for the issuance of future Task Orders to the Prime Contractor to outsource to an established Contract Research Organization (CRO) as their subcontractor? | The Prime Contractor should provide direct support for all task orders. However, sub-contracting can be utilized as the Prime sees fit. | N/A | ||
| 2 | General | Is the incumbent contractor providing full CRO services on the current contract? If so, are the incumbent contractor’s SOPs being used or are the full CRO services being performed using MRDC SOPs? | Yes, the incumbent contractor is providing the full CRO services on the current contract. MRDC SOPs are utilized by the incumbent contractor. | N/A | ||
| 3 | General | It appears that the Government’s intent is to utilize a CRO’s and other vendors versus maintaining a large contract staff. Question: Is this the Government’s intent? | The government's intent is to maintain a base of full-time contract staff at levels dictated by ongoing work. Additional task orders will be used to supplement regulatory support that cannot be covered by the initial task order staff due to required surge capacity. | N/A |
| 4 | General | In general, companies providing commercial CRO services do not typically place full-time personnel on a government contract, especially at a government location, because those employees are usually supporting work for several other ongoing clients/projects. A typical CRO requires freedom and flexibility in managing workloads and schedules to meet the needs of many clients. Please explain the government’s intent for operating as a CRO – is it expected that only full-time employees be utilized on Task Order #1 for full CRO services as currently estimated? | The government expects that support staff provided by the contractor operate as full-time support for Task Order #1. | N/A | ||
| 5 | General | Given the unknown nature of future Task Orders, will additional subcontractors be allowed to be added to the contract after award? | Adding subcontractors may be allowed with Government approval. | N/A | ||
| 6 | General | ORA staff are currently overseeing/reviewing/monitoring the work that other vendors, including CROs are performing. This includes overseeing work on clinical trial efforts for which a CRO may be involved. In addition, they are also assisting with developing a project plan that requires contracting out a piece of the work to a CRO. | It is anticipated that any actual, potential, and/or perceived conflicts of interest will continuously be monitored and mitigated by the contractor and the Government. | N/A | ||
| Question: How is the Government going to ensure the use of future CROs is going to be done in an impartial manner and not conflict with what the ORA office is doing for internal efforts? | ||||||
| 7 | Solicitation - CSS | A. Proposal Submission, 2. Proposal Files, d. CONTENT REQUIREMENT | 40 | The CONTENT REQUIREMENT states each volume shall contain a cover page, table of contents and glossary of abbreviations or acronyms. | No. | RFP amended to clarify page limits (page 39) |
| Question: Does the cover letter, title page, TOC, glossary of abbreviations/acronyms count towards the page limitations for Volumes I-III? |
8 Solicitation - CSS A. Proposal Submission, 2. Proposal Files, d. CONTENT REQUIREMENT, (i) VOLUME I – Technical, (1) Technical Approach for the Initial Task Order 40 Reference to the Quality Manual in paragraph 2, the Government states, “The Quality Manual shall describe how the Offeror will evaluate the subcontractors’ ability to meet FDA regulatory requirements.” The Offeror's Quality Manual is required to illustrate how the Offeror implements and adheres to a Quality System (in accordance with ICH and 21 CFR). One component of the Offeror's Quality Manual shall be a description of how it will evaluate its subcontractors' ability to also meet FDA regulatory requirements. N/A
| Question: Will the Government explain why this refers only to the subcontractors’ ability to meet FDA requirements? We recommend changing this to apply to the Offeror’s (Prime’s) corporation and employees as well as subcontractors. | ||||||
| 9 | Solicitation - CSS | A. Proposal Submission, 2. Proposal Files, d. CONTENT REQUIREMENT, (i) VOLUME I – Technical, (1) Technical Approach for the Initial Task Order | 40 | The Government states, “As part of the technical approach, the Offeror shall include a Quality Manual to illustrate implementation and adherence to a Quality System (in accordance with ICH and 21 CFR) in support of regulated activities and include a list of SOPs, including SOPs from proposed subcontractors.” | The Government does not require nor expect Offerors to submit copies of their SOPs or their proposed subcontractors' SOPs. The list of SOPs (to include SOPs from proposed subcontractors) is required to provide the Government with insight into the Offeror's Quality System and those of any proposed subcontractors, to demonstrate Offeror and subcontractor procedures for ensuring regulatory compliance, and to demonstrate that the prime Offeror has assessed their proposed subcontractors' Quality System. | N/A |
| Question: It is our understanding that Offerors are to use Government SOPs for work conducted under this contract. Companies, especially Contract Research Organizations (CROs), would resist sharing SOPs without knowing the actual product and work to be supported specific to that product. Will the Government please explain the rationale for requiring a list of Subcontractors SOPs? | ||||||
| 10 | Solicitation - CSS | A. Proposal Submission, 2. Proposal Files, d. CONTENT REQUIREMENT, (i) VOLUME I – Technical, (2) Experience | 41 | For the Key Personnel position of Pharmacovigilance Physician (PVP), please confirm the Offeror is only required to provide one resume for the full-time position? | Correct. | N/A |
| 11 | Solicitation - CSS | A. Proposal Submission, 2. Proposal Files, d. CONTENT REQUIREMENT, (i) VOLUME I – Technical, (3) Management Approach | 42 | The Government states in paragraph 1, “The Offeror shall describe its management approach and how it relates management activities to all contract requirements.” In paragraph 4, the Government provides the requirement for a Program Management Plan (PMP). The requirement includes a detailed staffing plan. | The government requires a PMP for the base IDIQ only. | N/A |
| Question: In our response, does the Government want a PMP for the IDIQ or does the Government want a PMP specific for the Initial Task Order? | ||||||
| 12 | Solicitation - CSS | A. Proposal Submission, 2. Proposal Files, d. CONTENT REQUIREMENT, (i) VOLUME II – Small Business Participation | 43 | For the Small Business Participation Commitment Document, does the Government have a Participation Commitment template that they would prefer we use? | No, the Government does not have a preferred template. | N/A |
| 13 | Solicitation - CSS | A. Proposal Submission, 2. Proposal Files, d. CONTENT REQUIREMENT, (i) VOLUME II – Small Business Participation, paragraph g | 43 | With regards to paragraph (g), in lieu of “…three Individual Subcontracting Reports (ISRs) for recent contracts (within the past three years from the closing date of this solicitation) that required a subcontracting plan” are Prime Contractors, that have a DCMA negotiated Comprehensive Small Business Subcontracting Plan, permitted to submit a recent Summary Subcontracting Report covering the comprehensive subcontracting plan?” | Yes, this is permissible. | N/A |
| 14 | Solicitation - CSS | A. Proposal Submission, 2. Proposal Files, d. CONTENT REQUIREMENT, (iii) VOLUME III – Past Performance | 43 | VOLUME III – Past Performance states, “This volume shall contain past performance information regarding similar contracts. This volume shall not exceed 25 pages plus five pages for each major subcontractor, excluding Past Performance Questionnaire Forms.” | The minimum number of references for the prime offeror is 3. The minimum number of references for each major subcontractor is 3. | Page 43, (iii) VOLUME III – Past Performance |
| Question: Will the Government please provide the minimum number of Past Performance References for the Prime and the minimum number of Past Performance References for each Major Subcontractor? | ||||||
| 15 | Solicitation - CSS | A. Proposal Submission, 2. Proposal Files, d. CONTENT REQUIREMENT, (iii) VOLUME III – Past Performance | 43 | VOLUME III – Past Performance states, “The Offeror shall also submit the written consent of its major subcontractors to allow the disclosure of its subcontractor’s past performance information to the Offeror. In addition, letters of commitment shall be included for all major subcontractors for their past performance to be considered.” | Letters of commitment and written consent from major subcontractors are not included in the page limitation. | Page 43, (iii) VOLUME III – Past Performance |
| Question: Please confirm that the letters of commitment and written consent from major subs are not included in the 5-page limitation for each subcontractor in Volume III Past Performance? | ||||||
| 16 | Solicitation - CSS | A. Proposal Submission, 2. Proposal Files, d. CONTENT REQUIREMENT, (iii) VOLUME III – Past Performance, (5) Past Performance Questionnaire | 44 | The Government states, “The offeror shall complete Part I of the Past Performance Questionnaire and e-mail the questionnaire to both the Government contracting activity and technical representative responsible for the past/current contract. The POCs shall be instructed to electronically complete Part II of the questionnaire and e-mail the entire questionnaire to the Contracting Office no later than the proposal due date, to herbert.e.keen.civ@mail.mil and dana.kavitski.civ@mail.mil.” | Yes. Only one person is required to complete the questionnaire. | Page 45, (5) Past Performance Questionnaire |
| Question: Based on our experience, Contracting Officers typically do not complete questionnaires due to not have direct knowledge of the work efforts and they have the Technical Representative/Contracting Officer Representative complete the questionnaire. Since we have no influence in ensuring that the Contracting Officer will also complete the questionnaire, will the Government remove this requirement and only require one (1) person complete the questionnaire? | ||||||
| 17 | Solicitation - CSS | A. Proposal Submission, 2. Proposal Files, d. CONTENT REQUIREMENT, (iv) VOLUME IV – Administrative, (c) Evidence of all Subcontractor Agreements and Teaming Arrangements | 45 | (iv) VOLUME IV – Administrative, paragraph (c) states. “Evidence of all subcontractor agreements and teaming arrangements shall be provided in this section.” | Yes. | N/A |
Question: Can a letter of commitment from each major subcontractor be submitted in lieu of providing a subcontract agreement and teaming arrangement?
18 Solicitation - CSS A. Proposal Submission, 2. Proposal Files, d. CONTENT REQUIREMENT, (iv) VOLUME V Price, (4) Labor Rates, 46 (iv) VOLUME V – Price, paragraph (4) Labor Rates states. “Offerors shall provide the underlying basis / rationale used in the development of labor rates in their accompanying narrative” Yes. N/A
Question: Can the accompanying narrative be submitted in PDF format?
| 19 | Solicitation - CSS | 52.212-2 EVALUATION--COMMERCIAL ITEMS (OCT 2014), C. EVALUATION APPROACH, 3. Small Business Participation Factor | 50-51 | Regarding the Minimum Quantitative Requirement(s), please confirm these are for the IDIQ as a whole and not a requirement on individual Task Orders? | Yes, this is for the IDIQ as a whole and not a requirement on individual task orders. | N/A |
| 20 | Solicitation - CSS | 52.212-2 EVALUATION--COMMERCIAL ITEMS (OCT 2014), C. EVALUATION APPROACH, 6. Other Items Reviewed | 53 | Regarding the Subcontracting Plan, our DCMA negotiated Comprehensive Small Business Subcontracting Plan is 44 pages long. | The Subcontracting Plan shall be provided in Volume II as an attachment. The attachment has no page limit. | Page 43, (ii) VOLUME II – Small Business Participation |
| Question (1): In which Volume does the Government want our Subcontracting Plan to be inserted into the Proposal? If in Volume II, will the Government remove the page limit requirement of 25 pages? | ||||||
| Question (2): Is it acceptable to insert it as an appendix in that volume and/or can we include just the Cover Sheet with our signatures?” | ||||||
| 21 | Solicitation - CSS | 52.212-2 EVALUATION--COMMERCIAL ITEMS (OCT 2014), C. EVALUATION APPROACH, 6. Other Items Reviewed | 53 | Prime contractors that have a Defense Contract Management Agency (DCMA) negotiated Comprehensive Small Business Subcontracting Plan (CSBSP) and therefore participate in the Test Program for Negotiation of Comprehensive Small Business Subcontracting Plans (Test Program) use their comprehensive subcontracting plans, in lieu of individual subcontracting plans, when performing any DoD contract or subcontract that requires a subcontracting plan, per 219.702-70. | If the successful offeror has a comprehensive subcontracting plan approved under the Test Program described in DFARS 219.702-70, the clause at DFARS 252.219-7004 will be used in the contract instead of the clauses at DFARS 252.219-7003, FAR 52.219-9, and FAR 52.219-16. | N/A |
| A. Proposal Submission, 2. Proposal Files, d. CONTENT REQUIREMENT, (i) VOLUME II – Small Business Participation | Question: Will the Government add clause 252.219-7004 Small Business Subcontracting Plan (Test Program) for those contractors holding a negotiated Comprehensive Small Business Subcontracting Plan?” |
| 22 | Attch05BasePrice Template | The Government has provided the labor categories to be priced for the IDIQ (and the Initial Task Order). Based on future Task Orders, will the Government allow additional labor categories to be added and priced to meet the requirements? | The Government will consider additional labor categories if necessary and within the scope of the contract. | N/A | ||
| 23 | Attch06TOLOE | In Attch06TOLOE, will the Government please provide the PWS Task numbers associated with each of the labor categories? | PWS Task numbers have not been associated with each labor category to allow offerors flexibility in proposed staffing. | N/A | ||
| 24 | Attch06TOLOE | In Attch06TOLOE, will the Government please provide minimum education and experience requirements for each of the labor categories? | The Government is not specifying minimum education and experience requirements for each labor category. | N/A | ||
| 25 | Attch06TOLOE | In Attch06TOLOE, of the 39 FTEs, will the Government provide the number of current vacancies include the specific labor categories for the vacancies? | This information will not be provided. | N/A | ||
| 26 | Attch06TOLOE | TO PWS 5.4 | 13 | In the Task Order PWS, Task 5.4 Quality, this section includes several tasks supporting quality reviews, audits, and inspections. However in the TO LOE there are no quality FTE’s assigned to perform these PWS tasks. | The TO LOE is correct. | N/A |
| Question: Can the Government please confirm that the TO LOE is correct? |
27 General FDA defines the responsibility of a SPONSOR in 21CFR 312.50 and in 21CFR 312.52 Transfer of obligations codifies that some or all responsibilities can be transferred to the CRO. No sponsor responsibilities are being transferred under this contract. All sponsor responsibilities are being maintained by the Government or other third parties. N/A
| Question: Which responsibilities are being maintained by the Government and which are they actually transferring to the CRO? | ||||||
| 28 | Attch07TOPWS22DEC2020 | 5.2.2 Performance Requirements | 6 | The following section implies the CRO is the Sponsor: Subtask 5.2.2 Regulatory Affairs: Serve as the primary contact with the FDA; review, analyze, and respond to FDA communications and meetings by the regulatory deadline. | Having a CRO serve as the Sponsor is a Program Development decision and outside of the scope of this contract. Work being conducted by the Offeror will be supporting projects for which TSG-DA serves as the Sponsor. Alternatively, oversight/consultative support may also be required in support of MRDC ORA for projects for which another third party services as the Sponsor. | N/A |
| Question: How much autonomy will the CRO have in implementing the responsibilities that have been transferred to it? | ||||||
| 29 | Attch07TOPWS22DEC2020 | 1.0 Scope and 5.0 Performance Requirements, paragraph 6 | 1, 4 | One page 1, the Government states, “The scope of this task order is for (1) regulatory consultation, (2) regulatory oversight, and (3) Contract Research Organization (CRO) support to include administrative, financial, clinical, nonclinical, manufacturing and regulatory support for drugs, biologics, and devices within an integrated product team framework as specified in the performance work statement (PWS).” Further on page 4, the Government states, “Contract Research Organization (CRO) Full Support… The Government estimates 10-15 ongoing clinical studies (typically Phase 1 and 2) will require full regulatory support each year. Other than active clinical trials the Government estimates that approximately 30 projects that will require full support for Regulatory Science and Regulatory Operations support, 20 projects will require full support for Clinical Trial Management, and 20 projects that will require full support for Investigational Product Management Support. | Question (1): Confirmed that the Initial Task Order #1 is for the existing effort being handled within ORA and the current contractor team effort. Question (2): The Offeror is to propose its own approach for selecting the number and type of subcontractors. For the initial task order, the contractor will support a wide range of products. It is not feasible for the Government to provide the list of products, timeline for support, and specific tasks for each product effort at this time. | N/A |
| Question (1): Please confirm that this Initial Task Order is for the existing effort being handled within ORA and the current contractor team effort, based on the estimated level of effort provided in Attachment 0006 of 39 FTEs? |
| Question (2): Is it the Government’s requirement for the Offeror to have a CRO as a subcontractor to support the performance of this Initial Task Order? If yes, in order for the Offeror to engage a CRO for this task order or any other task order, there are numerous additional specifications for which the Offeror will require from the Government to effective provide an approach and effectively price the requirement. Thus, will the Government please provide the list of products requiring full CRO support, time line for the support, the specific tasks for each product effort, etc.? |
30 Attch07TOPWS22DEC2020 and Attch06TOLOE 4.2 Place of Performance 1 Under Place of Performance in the Initial Task Order, the Government states that 22 Contractor employees will be able to work on-site at the Government’s facility. However, the LOE spreadsheet estimates that 36.5 FTEs will be on-site. The Government currently has 22 workstations available for contractor personnel. Due to space limitations, some personnel employed under the current contract telework full time; desk sharing and part-time telework is employed for others. Offerors may propose their own solution for accommodating these limitations. The Government is not specifying the duty location for each labor category. N/A
| Question: Will the Government please review Attch06TOLOE and identify the additional 14.5 FTEs (labor categories) that cannot be accommodated at the Government’s facility (i.e., which 22 FTEs/Labor Categories should be located at the Government site)? | ||||||
| 31 | Attch07TOPWS22DEC2020 | 4.5 Type of Contract | 2 | Due to the uncertainty of the specific workload that will be required with continual changes to product requirements due to the impact of COVID 19 and other factors, this could impact the required level of effort over time. In order to provide added flexibility to the Government and minimize the impacts to requirement changes, would the Government consider changing the type of contract to Time and Material (T&M)? | No. Although the Government anticipates a time and materials contract type will be suitable for some task orders, we have determined that a firm-fixed-price contract type is appropriate for the initial task order. | N/A |
| 32 | Attch07TOPWS22DEC2020 and Attch06TOLOE | 5.4 Quality | 13-14 | For Task 5.4, Quality, Attch06TOLOE has not included any estimated Labor Categories of a quality nature for this task. Are the quality tasks required in the Initial Task Order being performed by other labor categories or is this an inadvertent oversight? If this task is required, would the Government provide the estimate level of effort in Attach06TOLOE? | Attach06LOE is correct. Tasks required in 5.4 Quality can be performed by other labor categories. | N/A |
| 33 | Attch07TOPWS22DEC2020 | 12.0 Quality | 31-40 | FDA regulations and guidance are subject to interpretation and a single regulation or set of regulations (conduct of clinical trials, manufacturing, nonclinical studies, storage, etc.) may vary considerably depending on product lifecycle phase). The Acceptable Quality Level in the QASP are in many cases vaguely worded and are insufficiently specific to define a threshold standard that must be met. | In each case, the deliverable needs to meet current regulatory requirements for the clinical study phase being supported which will vary from product to product. | N/A |
| For example: Deliverable 10 - Regulatory Strategy - Compliant with all applicable regulatory requirements and delivered within 60 business days of request, AQL = 95% with periodic inspection | ||||||
| Deliverable 19 Data Management Plan (DMP) - Submit a final DMP that meets Good Clinical Data Management Practice (GCDMP) 14 business days for review and approval prior to study start The AQL = Approved DMP meets GCDMP with 100% Inspection | ||||||
| Deliverable 38 - Safety Management Plan - Approved safety management plan within 30 days of site initiation visit. The AQL = Approved plan in compliance with FDA, ICH, Office for Human Research Protections (OHRP), and DoD regulations with 100% inspection. | ||||||
| Deliverable 46 - IP Storage and Handling Instructions - NLT 5 business days after document receipt - Must be in compliance with all applicable regulatory requirements and have no more than 5% failure to comply per month -100% Inspection | ||||||
| There are at least 15 more stating in compliance with applicable regulatory requirements. | ||||||
| Question: Can the Government provide more specific thresholds for offerors or clarify? | ||||||
| 34 | Attch10TOPricing | CLIN 0001 and 0002 | Regarding the Transition CLINs (0001 and 0002) for Task Order pricing and the period of performance, will the Government please clarify if they are expecting full performance during the transition period with a start date of April 1 or full performance by the end of the transition period with a start date of May 1 (CLINs 0003 and 0004)? | 1-May | N/A | |
| 35 | General – beta.SAM.gov | Due Date | Due to the significant impact the Government responses have on completion of this proposal, we respectively request a 2-week extension of proposal submission to February 4, 2021. | The Government is unable to accommodate this request. | N/A | |
| 36 | CSS | Instructions on page 43 – “(ii) Volume II – Small Business Participation” | 43 | Subsection g) (Other than small business concerns only) Compliance with the terms and conditions of FAR 52.219-9, Small Business Subcontracting Plan … Please confirm that non-small businesses required to submit a Small Business Subcontracting Plan pursuant to 52.219-9 should include the plan as an attachment or part of Volume II? If not, please clarify where is should be appended. | The Subcontracting Plan shall be provided in Volume II as an attachment. The attachment has no page limit. | Page 43, (ii) VOLUME II – Small Business Participation |
| 37 | CSS | Instructions on Page 45 – “iv) Volume IV – Administrative Volume” and FAR 52.212-1 on page 69 | 45 and 69 | Page 45 - (iv)(b) Signed Solicitation Offer and Award Documents and Page 69 – 52.212-1 (b) referencing SF 1449. The instructions require us to sign the Proposal and Award Documents. |
a. Does this mean the Government wants offerors to include a signed SF1449, or can we submit our own standard cover page with an appropriate signature and then the winning bidder will sign the SF 1449 at the time of award?
b. If we should submit an SF 1449 (or some other official proposal form), will the Government provide a copy that includes all the information the Government normally completes at the time it releases a solicitation (or should offerors fill out the Government information on the form)
| A 1449 is not required. The offer should comply with the requirements at FAR 52.212-1(b) beginning on Page 69. | Page 45 , (iv) VOLUME IV – Administrative, Section (b) | |||||
| 38 | Attach07 TOPWS | 6.2 Monthly Task Progress Report – DELIVERABLE 1, page 14 | 14 | The Contractor shall submit a Monthly Task Progress Report for this task order as a deliverable to the Government (Deliverable 1). The Contractor shall submit the report with a transmittal letter not to exceed two pages that highlights major events and deliverables in the reporting period. Please confirm whether the monthly task progress report should include a progress report for each individual employee or if a summary of all employee activities is required. If the former, will the report still be limited to two pages? | Only the transmittal letter that accompanies the full report shall be limited to 2 pages. The Monthly Task Progress Report does not require reports for each employee. It is only required to contain the information required in Section 6.2. | N/A |
| 39 | Attch05BasePriceTemplate.xlsx | T&M On-Site and T&M Off-Site | N/A | The government provides 38 Labor Category Titles but does not provide corresponding LCAT descriptions or qualifications. Will the government please clarify if offerors are to develop their own descriptions/ qualifications or will the government provide? | Offerors should develop their own descriptions/qualifications. | N/A |
| 40 | Attch05BasePriceTemplate.xlsx & CSSW81XWH21R007822DEC2020.docx | 4.2 Place of Performance | 3 | The government states “The Contractor may be required to perform at the Government’s facility, located at Fort Detrick, MD 21702, other Government facilities”. Given these are ceiling rates, and various geographic locations could impact fully burden rates, will the government provide a listing of “other government facilities” locations so offerors can take these into account when developing rates? | The only Government facility for place of performance is located at Fort Detrick, MD 21702. | Page 3, Section 4.2 Place of Performance and Attachment 7 TO PWS Section 4.2 |
| 41 | CSSW81XWH21R007822DEC2020.docx | 4.5 Type of Contract | 4 | The government indicates Firm Fixed Price “FFP” task orders will be issued but also ask for “hourly rates” in Attachment 05. Will the government please clarify if the FFP hourly rates are for Firm Fixed Price Level of Effort (FFP LoE) Term or true Firm Fixed Price (FFP) Completion, paid on a deliverable? | FFP Completion. The Government expects that the unit of measure may vary (i.e., months vs. deliverables) per task order. For example, the initial task order is to be priced on a monthly basis. | N/A |
| 42 | CSSW81XWH21R007822DEC2020.docx | 6.7 Key Personnel | 18 | The Government list a “Contractor Task Manager” and an “Alternate Contract Task Manager”. These two positions are also listed in the initial Task Order. – Attachment 05 price template does not list these LACTs. Are these LACTS represented by the “Project Manager” LCAT title? Please clarify. | The Government will update Attachment 05 to change 'Contract Task Manager' to 'Contractor Task Manager.' The Alternate Contract Task Manager is intended to be the back-up for the Contractor Task Manager and does not need to be its own labor category. Project Manager is a separate labor category. | Attachment 05 |
| 43 | CSSW81XWH21R007822DEC2020.docx | Section 1 Subfactor 1 | 40 | The government states “As part of the technical approach, the Offeror shall include a Quality Manual to illustrate implementation and adherence to a Quality System”. Will the government please clarify if the offerors, and their subcontractors, Quality Manual is included in the Volume 1 page count or should it be included as a separate attachment outside of the page count? The combination of the prime and all subcontractors could significantly impact page count restriction if the language is intended to be included within the Volume 1 120-page limit. |
Can the government clarify the major content that should be contained within the quality manual with respect to the quality plan?
| The Offeror's Quality Manual is included in the Volume 1 page count. Separate Subcontractor Quality Manuals are not required. The Quality Manual shall describe how the Offeror implements and adheres to its Quality System (in accordance with ICH and 21 CFR) in support of regulated activities generally, to include specific items listed in the RFP. The Quality Control Plan shall describe how the Offeror will meet and comply with the quality standards established in the task order PWS specifically. | N/A | |||||
| 44 | CSSW81XWH21R007822DEC2020.docx | Section 2 – Subfactor 2 – Task Order 1 Key Personnel | 41 | The Government list a Contractor Task Manager, Alternate Contractor Task Manager. Financial Support Specialist, and Pharmacovigilance Physician but does not provide a description of desired key personnel qualifications, years’ experience, or description. Will the government please clarify if offerors are to develop their own descriptions or will an amendment be provided with the governments desired qualifications? | The offerors should develop their own descriptions, qualifications, etc. | N/A |
| 45 | CSSW81XWH21R007822DEC2020.docx | 11.0 Contractor Personnel Security Requirements | 31 | Will the government be providing a draft DD 254 for initial Task Order? | Yes | Attachment added to RFP. |
| 46 | CSSW81XWH21R007822DEC2020.docx | Subfactor 3 – Management Approach (Transition) | 49 | Item “f” addresses “transition of historical data to new contractor system”. Will the government provide what data is currently maintained by the incumbent and the system currently utilized by the incumbent so offerors will have the ability to adequately address this requirement for transition? | Item "f" was included in error. All data that would be needed by a new contractor is maintained on Government systems. | Item "f" is removed. |
| 47 | CSSW81XWH21R007822DEC2020.docx | Paragraph 2: Consultation |
“The Government anticipates 50 regulatory projects (e.g., clinical, nonclinical, and manufacturing) will require regulatory consultation support each year.”
| 5 | Can the Government provide any projections into pending task orders which may be issued in the base contract PoP? Should the awardee assume that these task orders will be released singularly, or does the Government anticipate the potential of simultaneous release of multiple Task Orders? | Due to ORA's fluctuating workload, t, the Government is not able to provide projections. The Government expects task orders will be released singularly but it is possible task orders may be released simultaneously. | N/A | |
| 48 | Attch08TODeliverables.docx h8 | Provide final raw data in Statistical Analysis Software(SAS) format compliant with CDASH and applicable CDISC standards prior to the transformation to SDTM datasets (Deliverable 27) | N/A | Does the Government intend to require all offerors to use SAS® software specifically, or is SAS (as referenced in the RFP) a generic use of the phrase? If SAS is a generic use, will any statistical analysis software (and format) that is compliant with CDASH and applicable CDISC standards be considered acceptable to the Government? |
The Government utilizes SAS software specifically. Therefore, the
| Government will require the contractor to use SAS. | N/A | ||||
| 49 | Attch11USAMRDCORASOP.xlsx | SOPs | N/A | Are all MRDC ORA SOPs identified in Attachment 11 currently in use by the incumbent contractor? If so, to ensure fair competition will the government provide the following SOP documents for bidders to consider? For Example: |
a. SOP.5.03.F02 SADE_UADE_SAE Report Form and Guidelines
b. SOP.5.04.F01 DSMB Conflict of Interest Statement
c. SOP.6.05.F01 GLP Study Protocol Checklist
d. SOP.2.01.F02 Site Qual_Pre-Study Monitoring Visit Summary.pdf
e. SOP.9.13 Enclosure 1 Reg Proj Bus Process Flow 06MAR2020.pdf
f. SOP.9.07 Document Control System for Standard Operating Procedures Form (v01)
g. SOP.5.05.F04 Protocol Package Requirements List
h. SOP.6.04 PTO Oversight of Product Testing (v00)
i. SOP.5.01 Invest Product Safety Event Processing and Preparation of Exped
j. SOP.1.01 Good Statistical Practice in Clinical Research (v00)
k. SOP.5.02 Use of Safety Surveillance Database for FDA-Regulated Clinical Trials (v00)
l. SOP.6.05 GLP Study Protocols and Reports (v00)
m. SOP.9.01 Mnmgt of Ext Inspections Performed at Office of Regulated Activities (v00)
n. SOP.8.04 Regulatory Submissions Process (v00)
o. SOP.2.08 Clinical Monitoring Plan Development (v00)
p. SOP.7.06 Procedure for Responding to a Clinical Hold (v00)
q. Unnumbered- Investigational Product Safety Event Processing and Preparation of Expedited Safety Reports for FDA-Regulated Clinical Trials
r. Unnumbered- USAMMDA Managers' Internal Control Plan
s. SOP.1.01.F03 Early Phase Clinical Development Plan (Vaccine Example)” Yes, the MRDC ORA SOPs identified in Attachment 11 are currently in use by the incumbent contractor. The SOPs are included in the RFP as an attachment to the PWS because the contractor will be required to comply with these SOPs during contract performance. They will be provided to the successful Offeror upon contract award. The content of the SOPs listed in Attachment 11 is not relevant to the instructions to offers or evaluation criteria in the RFP, and no offer will be evaluated for familiarity with the SOPs. Therefore, an Offeror's specific knowledge (or lack thereof) of the content of these SOPs
| does not affect the fairness of the competition. | N/A | ||||||
| 50 | CSSW81XWH21R007822DEC2020.docx | Addendum to FAR 52.212-1, A. Proposal Submission, 2. Proposal Files, d. Content Requirement: “A table of contents and glossary of abbreviations or acronyms should be included in each volume.” | 40 | The Government stipulates in the solicitation that a Table of Contents and glossary of abbreviations are required in each volume. Separately, the government stipulates a cover page for each volume. Please confirm that the table of content, glossary, and cover page, as well as any list of figures, tables and drawings, will be excluded from page count requirements as stipulated in the solicitation. | Table of contents, glossary of abbreviations, and cover page are exempt from page limits. | Page 39, Section e. | |
| 51 | CSSW81XWH21R007822DEC2020.docx | N/A | N/A | Due to the volume of expected clarification with respect to pricing, technical, past performance and material regulatory questions during the Q&A period that will impact offerors’ response to the solicitation, in combination with the ongoing surge globally regarding COVID-19 pandemic, will the Government consider extending the proposal submission date four weeks. | The Government is unable to accommodate this request. | N/A | |
| 52 | N/A | N/A | N/A | I am hoping to find out if there is an incumbent contractor currently performing these services, if similar services have been performed in the past, or if this is a new requirement. If this is a follow-on requirement, could you please provide the previous contract or task order number? | This is a follow-on requirement to W81XWH-18-C-0178 with ICON Government and Public Health Solutions. | N/A |
File details come from the government source that posted it. Updated .