Amendment 1 - 9.11.20..pdf

Amendment 1: 75N93019R00025

Amendment No.1 75N93019R00025

“Comprehensive and Rapid Response to NIAID Research Programs”

Solicitation Number:

Amendment Number:

Amendment Issue Date:

75N93019R00025

One (1)

September 11, 2020

Proposal Due Date/Time: Tuesday, October 1, 2020 at 3 pm, Local Time (Unchanged)

Issued By: Callie Prassinos Contracting Officer OA/DEA/NIAID/NIH/DHHS

Point of Contact PRIMARY:

Matt.Lear@nih.gov

Matt Lear, Contract Specialist Phone: 240-669-5109

SECONDARY:

prassinosca@niaid.nih.gov

Callie Prassinos, Contracting Officer Phone: 240-669-5155

Please note that we do NOT intend to extend the due date for submission of proposals as a result of this Amendment. The date specified for receipt of proposals remains unchanged.

The purpose of this Amendment is to:

1) Answer questions from potential offerors regarding the solicitation

2) Include additional information about DCR special project sites and networks, attached

Offerors must acknowledge receipt of this Amendment by identifying this amendment number and date of the amendment on each copy of the proposal submitted. Failure to receive your acknowledgement may result in the rejection of your proposal. Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.

1). On page 221, #3, it states that “Please include responses to C-3 Non-traditional Animal Models (all offerors responding to Task Area C must include this in a proposal response)” however it was brought to attention that the SOWs for the base contract general task order requirements, task area requirements and sample task order within the task area are missing for C-3.

Response: There is no sample task order for C-3. Please reference page 228 for the information that the Government is looking for in a response to C-3. The Government is not looking for a proposal about Non-traditional Animal Models. We are looking for information on capability and approaches.

2). On Attachment 3, Base Contract Statement of Work, Section 2 g.; Do these regulatory activities associated with clinical trials exclude the regulatory scope included in Task Area F, Regulatory and Quality Assurance Services?

Response: These should not be excluded.

3). On Attachment 4, Sample Task Order, Task Area A, Task Order A-1, Section 1 p.; Will sites maintain their own data management systems rather than the contractor developing a central multi-site data management system?

Response: For this Sample Task Order, contractors should propose their own data management system. In future task order requests, this would depend on what is available and the type of study.

4). Attachment 4, Sample Task Order, Task Area A, Task Order A-1, Sections 1 s. and 1 t.; Please clarify whether site investigators will develop, implement, and manage their own research protocols.

Response: Yes, the protocol must be in line scientifically with NIAID portfolio/mission and the resources for the protocol must also meet contract requirements.

5). Attachment 13, Additional Technical Proposal Instructions, Format for Technical Proposal, and Table of Contents; Please clarify how the expected content for Section 3, Technical Plan/Approach for the Base Contract Statement of Work differs from the expected content for Section 4, Technical Plan/Approach for each Task Area.

Response: Section 3 is to address the Base Contract Statement of Work and Section 4 is to address the Task Area/ Sample Task Order in which is being proposed.

6). Attachment 13, Additional Technical Proposal Instructions, Format for Technical Proposal, and Table of Contents; The Table of Contents notes that offerors responding to Task Area A should include responses to Sample Task Orders in both Section 4 II A. Sample Task Order Responses, and Section 8.

How does the expected content for these sections differ?

Response: There are two sample task order in Task Area A that will need to be addressed when proposing to Task Area A. Section 8 is stating that the two sample task orders should be separate in the technical proposal and clearly identified as such.

7). Attachment 5, Sample Task Order, Task Area A, Task Order A-2, Section C.2; The passage states “Provide a laboratory in Phnom Penh (in space provided in the CNM facilities) equipped with state-of-the-art equipment…”. Please clarify if this work is intended to be supported at an existing laboratory at CNIM (e.g. the MVRL) and/or if the contractor will be required to provide capacity building support (e..

infrastructure, equipment, and other resources) for establishment another laboratory at CNM to support the required RT-PCR/ELISA testing services.

Response: The offeror should propose on how best to meet this requirement.

8). Attachment 14, Additional Business Proposal Instructions and Uniform Cost Assumptions, Section 3.1) B, 1 and 2; The UCA for Task Orders A-1 and A-2 is an estimated 3-year period of support. What start date should be used for the 3-year period?

Response: Since the sample task order will be used for evaluation purposes only and not be awarded, please use 3 years starting May 1, 2021.

9). Is there an element of SME support in the contract, in addition to CRO-like services?

Response: SME support can be proposed if it meets the requirements of the SOW.

10). Can you specify what this RFP is for?

Response: The RFP is to have a contract mechanism to deploy the NIAID research toward rapid interventions for public health. Please reference the solicitation for more information.

11). What is the anticipated number of base contract awards to be made as a result of a potential solicitation?

Response: The anticipated number of awards will depend on the proposals received under each task area. NIAID will evaluate the program needs and technical criterial to determine the best value contractors to award under each task area. We anticipate anywhere from 2 to 4 awards under each task area.

12). Are certain Task Areas set-aside for small businesses or does the Government plan to award a certain number of multiple-award base contracts to X number of large businesses and X number of small businesses?

Response: Task Area F is set-aside for Small Business.

13). In Task Area D, in order to facilitate development of a cost proposal specific to the sample task order D-1 scope, would the Government please provide level of effort information and other assumptions with regard to Statistical Support for HIV Nonvaccine Biomedical Prevention Product Development sample task?

Response: Please reference page 238 of the Business Proposal Instructions for any cost assumptions associated with D-1.

14). When is the expected RFP release date for the Comprehensive and Rapid Response to NIAID Research Programs? Is this a new program specifically set up to expedite preclinical services for medical countermeasures for pandemics to ease pressure from the existing extramural preclinical programs?

Response: The RFP was released on July 20, 2020. The RFP is to have a Contract mechanisms to deploy the NIAID research toward rapid interventions for public health. Please reference the solicitation for more information.

15). In Attachment 1, Packaging and Delivery of Proposal, Page 3; Please confirm the two-page CVs are exempt from the Technical Proposal page limits for each Task Area.

Response: As stated in Attachment 1, Packaging and Delivery of Proposal, the only items that do not count towards the page limited is Title and Back Page; Table of Contents; Section Dividers that do not contain information other than title of Section; and The Human Subject and Clinical Trial Information Form, if required by the solicitation. The CVs are included in the page count.

16). In Attachment 4, Task Area A-1, Page 2; Assuming each clinical site has varying clinical research capacity, can NIAID/DCR specify the 4 clinical research sites in Monrovia, Liberia, or is it a requirement of the offerors to propose the 4 sites we would utilize?

Response: Yes, the sites are JFK Medical Center, C.H. Rennie Hospital, Duport Road Clinic, and Redemption Hospital.

17). In Section L, Page 94, 16. Past Performance Information; The last sentence of the paragraph states, “For the purposes of this solicitation, a major subcontract is defined as any subcontract exceeding $750,000 in total costs.” Does this mean subcontracts exceeding $750,000 can be used as past performance?

Response: Yes, any subcontractor proposed to exceed over $750,000 will be used in the past performance evaluations.

18). In Section L, Page 94, 16. Past Performance Information; Can the offeror submit Grants and/or Cooperative Agreements as Past Performance references?

Response: Yes, the Government will receive any information about past performance. Please provide enough information to help the Government to follow reference and make determination on the performance for evaluations.

19). In Attachment 3, Page 1, 1. Background and Introduction; The last sentence of the fourth paragraph states, “DIR research is conducted primarily on the main NIH campus and at NIAID Rocky Mountain Laboratories located in Hamilton, Montana.” Are offerors to assume most of the work performed on these task orders will be at NIAID laboratories? Or is the Government expecting offerors to provide laboratory facilities?

Response: The locations for DIR laboratories was noted, primarily so that offerors for relevant Task Areas would understand that not all work will be in the greater Bethesda area. Actual location will vary by both Task Area and Task Order. For much, but not all, of the work covered under this contract, NIAID assumes the work will be done at the Contractor’s facility or other sites as directed by the task.

For example, in setting up clinical trial sites, NIAID expects that some US studies will be performed at the Contractor site or at existing trial clinics that are subcontracted by the prime Contractor. We also expect to have tasks to support or establish/maintain ex-US clinical sites in both developed and low resource countries.

For some Task Areas, e.g. B and C, we expect virtually all work to be done at the Contractor’s site. We understand some work might be subcontracted.

For some task areas, or specific requirements, some work might be done at NIH facilities. For example, a contractor setting up a data storage system might come to NIAID to install the interface or train NIAID users.

20). On Attachment 14, Page 1, 1. Business Proposal-Table of Contents; Would the Government advise how many Business/Cost proposals offerors need to submit if they respond to a task area with two sample task orders?

Response: Each sample task order should have a budget within one business proposal to be used for evaluation of cost and price.

21). On Attachment 14, Page 1, 3; If offerors respond to multiple task areas and they are all awarded, will there be a base contract consisting of multiple task areas or multiple base contracts?

Response: An Offeror would be awarded 1 base contract with multiple task areas.

22). In Attachment 24, Breakdown of Proposed Estimated Cost (plus fee) with Excel Spreadsheet; Are offerors allowed to use their own budget template for the cost proposal or is it required to use the budget template provided?

Response: The template is not required but strongly advised. The template is to show all the information that the Government will need to evaluate the costs. If other templates are being used, please ensure that all cost is broken down and clearly labeled to help the Government determined cost realism and evaluate fairly among all offerors.

23). In Section L, Page 126, 6. Small Business Subcontracting Plan; Would the Government clarify if a small business subcontracting plan is required for the base contract only or does the Government expect a small business subcontract plan for each sample task order response?

Response: A Small Business Subcontracting Plan is only required under the Base Contract and for the max ceiling amount.

24). In Section C, Page 9, C.1 Statement of Work; For many of our research engagements, we work closely with DoD/US Government PIs in government facilities. Are DoD/US government investigators and/or other USG facilities allowable resources for inclusion in our technical response for this IDIQ and subsequent task orders? For example, the sample Task Area G-1: Monoclonal Antibody Tissue Cross-reactivity requires design and execution of a GLP-compliant, IND-enabling TCR study utilizing an antibody candidate. If we have access to this capability through our government partners would NIAID be ok with including them in our proposal?

Response: Support can be proposed if it meets the requirements of the SOW.

25). In Task Area G, Basic and Mechanistic Studies and Specialized Services, Task Area G-1; It states “The VCMP is requesting support from a contract research organization to perform tissue cross-reactivity (TCR) studies using investigational human monoclonal antibodies.” Does this mean the offeror must be a Contract Research Organization (CRO) in order to respond to Task Area G?

Response: The work should be performed by a GLP lab. The offeror should have the capability to maintain a panel of 30 different tissue samples from mouse, (or a small animal that VRC proposes) and humans. For each tissue they should also maintain tissues sourced from 3 different subjects. In our experience, established labs performing work per established GLPs including CROs have been able to perform these services in the past.

26). In Task Area G, Basic and Mechanistic Studies and Specialized Services, Task Area G-1; It states “Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, materials, equipment, and facilities, not otherwise provided by the Government under the terms of the contract,…”. Will the Government be providing the materials, equipment, and facilities required for this task order or should the offeror include these ODCs in our proposal?

Response: This will be task order specific and will be clear after award of the base contract and ordering task orders. But at this time for evaluations proposes, the Government will not be providing any materials, equipment, and facilities. The Offeror shall have the technical expertise, facilities, and tools to perform the task as defined in the RFP. The Government will not support costs/expenses to purchase/acquire facilities/equipment in order to appropriately execute studies given in the RFP. As stated, the Offeror shall furnish these services, equipment and other necessary tools. There may be exceptions in very specialized cases. Moreover, the Offeror is advised to read other parts of the RFP for qualification criteria.

27). In Attachment 13, Additional Technical Proposal Instructions, Format for Technical Proposal, and Table of Contents, Section 3; Should this section contain our approach to the general task order as outlined on Page 154, Statement of Work general task order requirements?

Response: Yes, please include in section 3 the technical approach to the general contract requirements.

28). In Attachment 13, Additional Technical Proposal Instructions, Format for Technical Proposal, and Table of Contents, Section 7; The staffing plan for Section 7 Project Management seems to request the same information as the staffing plan requested under the Human Resource Management of Performance Management on page 222. How is this staffing plan different than the staffing plan requested for Human Resource Management? Is it acceptable to address the staffing plan in Section 7 only?

Response: Please address the Human Resource Management and Performance Management/ staffing plan in either section and reference that section in the other section.

29). The project management systems and communication in Section 7 in Attachment 13 seems to request the same information as the project management section in the general task order. How are these sections different? If not, different, it is acceptable to address in Section 7?

Response: Please address in either section and reference that section in the other section.

30). In Attachment 13, Additional Technical Proposal Instructions, Format for Technical Proposal, and Table of Contents, Section 6; Facilities, Equipment, and Resource Support and Operations is requested as Section 6 as well as part of the general task order response. How are these sections different? If the section is not different, is it acceptable to address in Section 6 only?

Response: Please address in either section and reference that section in the other section.

31). In Sample Task Order B-1, page 185; Prepare plasmid vector for R/D and GMP work (400mg).

Section D Government Furnished Material/Responsibilities (page 186) of the same sample task order, it indicates that NIAID will provide plasmid expressing EXV gp372. Please clarify. Will the plasmid received be research or cGMP grade? Is the expectation of the task to produce both R&D and GMP grade material at 400 mg each?

Response: Under this contract, the Contractor might be asked to expand the plasmid to provide a Master Bank to support cGMP manufacturing, to expand the plasmid and produce a research bank to support further research and development, to manufacture cGMP drug product, etc., or some mixture of activities. The specific requirement will be defined by Task Order.

For purposes of the sample Task Order, Offerors should assume the provided research-grade plasmid will be expanded under cGMP to produce 400 mg of purified plasmid, vialed as a cGMP Master Bank. A fraction of this bank will be used by NIH to support R & D studies. Most of the bank will be used to support cGMP product manufacturing and to create an enduring Master Bank.

32). In Sample Task Order B-1, page 184; It states, “A sufficient quantity of NIAID-produced nanoparticles will be provided to complete the technology transfer activities.” Please clarify how much material will be provided.

Response: The required amount would be negotiated with the Contractor as part of task order award. For purposes of responding, Offerors may assume that NIAID would provide up to 100 vials at the concentration and volume as required for Final Drug Product.

33). In Sample Task Order B-1, Milestone 2, page 184; Please clarify the scope for Task 5 “Administration stability studies to support animal and human studies”- Is this in addition to the other stability studies listed under the milestones in the scope (i.e. pulls and duration)?

Response: The scope for Milestone 2 differs primarily in the material being tested, the Engineering Lot. Later Milestones refer to the cGMP products (vaccine and diluent). Offerors should assume that Engineering Lot material will be used for both the Reference Standard and the ‘Tox Lot.’ The Milestone 2 stability protocols should be appropriate for these uses.

34). In Sample Task Order B-1; Task Order B general requirements state product formats may include shortmers. Would you please define what is meant by shortmers?

Response: Shortmers refers to formats such as oligomers, peptides, etc., smaller versions of biological molecules that also exist as large, usually polymeric, forms. The generalized term Shortmers was used to capture all known and potential formats.

35). In Section J, List of Attachments; It contains links to several attachments which do not seem applicable to all Task Areas at the IDIQ stage. Please confirm which, if any, attachments need to be included as part of our response to this RFP for Task Area A.

Response: All attachments, except the ones about animals, are applicable to a proposals for Task Area A.

36). In Section J, List of Attachments; For any attachments required to be submitted at the IDIQ stage, please confirm these are not included in the overall page limit.

Response: The only items that do not count towards the page limits is Title and Back Page; Table of Contents; Section Dividers that do not contain information other than title of Section; and The Human Subject and Clinical Trial Information Form, if required by the solicitation.

37). In Section L.2.b.4, Human Subjects on page 100; While we can speak to our SOPs and general capabilities in protecting participants in trials, the specific Human Subjects request does not seem applicable at the IDIQ stage (i.e., selection criteria, proposed dates of enrollment, etc.). Please confirm this is for informational purposes only, will only be required on future task orders as applicable, and it is not required at this time?

Response: If the offeror has general SOPs in place for the protection of human subjects at any phase of the trial, these should be included. Please reference page 136 of the RFP, Section 3 Human Subjects Evaluation for information to be used in evaluation for award.

38). On page 112, Section L.2.b.4.i HIV Antiretroviral Treatment Trials; As we are not committing to perform an HIV treatment trial at this time, please confirm the HIV Antiretroviral Treatment Trials plan is not required at this time and will only be required on future task orders as applicable.

Response: This is correct. This will be a requirement at the time of a Request for Task Order Proposal, if applicable.

39). On page 117, Section L.2.b.5, Research Involving Live Vertebrate Animals; Please confirm this is not required at this time for Task Area A and will only be required on future task orders as applicable.

Response: Research Involving Vertebrate Animals are under Task Area C only and Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals are required at this time. There will be no animal research under Task Area A. Therefore, if the proposal is for Task Area A only, this is not required.

40). On page 199, Section L.2.b.8, Enhancing Reproducibility through Rigor and Transparency; Please confirm that this is not required at this time and will only be required on future task orders as applicable.

Response: As stated in Section L.2.b.8, “the offeror shall demonstrate compliance with the NIH policy on Enhancing Reproducibility….”

41). Under Section M, Evaluation Factors; Please confirm that 3-Human Subject Evaluation, 4-Live Vertebrate Animals Evaluation, 5-Evaluation of Authentication of Key Biological and/or Chemical Resources, 6-Evaluation of Data Sharing Plan, 7-Evaluation of Plan for Sharing Model Organisms for Biomedical Research, and 8-Evaluation of Plan for Submission of Genome-Wide Association Study (GWAS) Data are not applicable at Task Area A for this IDIQ and will not be evaluated.

Response: If proposing to Task Area A, all will be evaluated except 4 – Live Vertebrate Animals Evaluations as task area A does not have any animal research.

42). Considering the size and scope of the opportunity, would NIAID consider an extension of the October 1 due date?

Response: We do not currently anticipate issuing an extension.

43). In regard to all Task Areas, will NIAID require labor rates to be established at the IDIQ level for all possible resources that could perform on the future task orders?

Response: No

44). On page 100, it states “Important note to offerors: The following subparagraphs shall be addressed, as applicable, in a separate file of the Technical Proposal entitled ‘Human Subjects’”. Does the Government intend offerors to include this section in all Task Area proposals?

Response: No, only in task areas where Human Subjects are applicable.

45). Pages 154-156 are repeated on pages 156-159. Page 160 is repeated on page 161. Would the Government please delete the repeated pages and repaginate the solicitation, so offeror can clearly cross-reference these SOW sections in our proposal?

Response: The Government did not find this in the solicitation. No action will be taken.

46). Under Technical Proposal Instructions, Section 4, Technical Plan/Approach for each Task Area, II, Clinical Trials and Human Subjects Research; Does the Government intend that offerors provide their responses to Sample Task Order A-1 and A-2 in proposal Section 4, Sub-section II, Sub-section A, or in Section 8 Sample Task Order and Options? May offerors use Section 4, Sub-section II, Section A to respond to SOW requirements for Individual Task Area Clinical Trials and Human Subject Research SOW and provide responses to Sample Task Orders A-1 and A-2 in Section 8?

Response: Please propose in one section and reference it in the other.

47). On page 160, Task Area A, Clinical Analysis; Will there be task orders where only sample management, logistics and storage are required, such that analysis will be performed by the Government or its contracted clinical/specialty lab?

Response: Yes, this is possible depending on the government’s future needs.

48). On page 160, Task Area A, Clinical Analysis; Will the contractor be responsible for identifying and contracting with a laboratory for analyses?

Response: Yes, this is possible depending on the government’s future needs.

49). On page 161, Task Area A, Supply Chain and Logistics (ix); Can NIAID name the current software and requirements for compatibility? Is the contractor expected to use inventory management software, or is a documented process for use of spreadsheets acceptable for inventory management purposes?

Response: There are many software packages across NIAID. Finale is one inventory management system being used, but many others are available and greatly depend on the needs of the program. This will be detailed in future task order requests.

50). On page 161, Task Area A; Will the Government please confirm if Category A infectious substances/specimens are to be involved in the collection and shipment scope? What about radioactive substances/specimens?

Response: Assume that category A- infectious substance/specimens- yes. Radioactive substances/specimens- no.

51). On page 161, Task Area A; Is work under Task Area A anticipated to require an Institutional Biosafety Committee?

Response: Yes, this is possible depending on the government’s future needs. This will be detailed in future task order requests.

52). On page 161, Task Area A; What entity(ies) are responsible for provisioning the investigational product, reagents, pathogens, organisms and specimens?

Response: This could be a host of suppliers including pharmaceutical companies, sub-contractors, government entities, individual investigators and other collaborators and will be detailed in future task order requsts.

53). On page 161, Task Area A; Is the contractor required to provide for IP packaging and labelling by a

CMO?

Response: Yes, this will be detailed in future task order requests.

54). On page 141, Task Area A, Technical Evaluation Criteria; It states, “Adequacy of proposed plan to address relevant biological variables, including sex for studies in human subjects as applicable.” Can the Government provide more context to this criterion, so the offeror can ensure it is addressed appropriately? Does this criterion refer to page 136, Human Subject Evaluation?

Response: This criterion is making sure such aspect as adequate representation of participants in studies is addressed with areas such as sex and racial diversity.

55). On page 177, Task Area A, Sample Task Order A-1; Is the contractor required to identify and contract with the testing laboratory and/or repository (mentioned in h.vi. courier services), or will that be selected by NIAID? If selected by NIAID, what should offerors assume for lab geographic location?

Response: For the evaluation purposes of the sample task order, the Contractor may identify the lab/repository.

56). On page 171, Task Area A, Sample Task Order A-1; While the RFP specifies the number of sites to be located in Monrovia, how many patients should we anticipate enrolling in the ebola portfolio?

Response: This would depend on the study so the offeror should provide numbers they would be capable of supporting.

57). On page 180, Task Area A, Sample Task Area A-2; it states “MVRL is fully equipped to perform the required laboratory assays and the state-of-the-art insectary at CNM will support experimental entomology. Fully trained Cambodian staff are available for each of the activities”. What activities does this refer to?

Response: Please refer back to the activities stated in the background of sample task area A-2.

58). On page 181, Task Area A, Sample Task Order A-2; Are there existing “qualified personnel (e.g.

program manager, site manager, data manager, office manager, lab technicians)” on site who are supporting NIAID initiatives?

Response: This is a new requirement therefore we cannot identify personnel currently on site.

59). On page 166 and 199, Task Area D; The Task Area D requirements on page 166 include several bioinformatics and analytics capabilities. However, the Sample Task Order on page 199 focuses on the biostatistical services and is limited in the bioinformatics requirements. How will the Government assess the offerors costs reasonableness for bioinformatics activities if there no associated sample task order activities?

Response: The Government will analyze the cost for the sample task order requirements.

60). On page 166, Task Area D; States “Provide infrastructure for the integration and access of multi-scale data, co-located with computational tools”. Does NIAID currently use a data standard, or would offeror be required to define standards to use in the integration of datasets?

Response: This is a new requirement please identify define standards.

61). In Task Area D, will the electronic data collection (EDC) system and other related systems currently in use be transferred over to a new contractor or can another electronic data capture system be proposed?

Response: This is a new requirement, therefore there is no system currently in use to be transferred.

62). In Task Area D, how is the data stored? Is it in a commercial database, or in a specific format like CDISC SDTM SAS datasets?

Response: This is a new requirement, therefore there is no commercial database.

63). In Task Area D, what software tools are currently in use? Will these transfer over to a new contractor or are they proprietary requiring a data migration plan?

Response: This is a new requirement, therefore there is no system currently in use to be transferred.

64). In Task Area D, the description of IT architecture and software indicates a local area network, can a cloud based solution meeting FISMA and FedRAMP requirements be proposed for hosting applications?

Response: Please submit a proposal and the Government will evaluate it.

65). In Attachment 12, roughly what percentage of work is anticipated to require GLP capability?

Response: The term GLP might be something of a misnomer here. This is not a live animal test or experiment. NIAID requires that the testing be done under control systems that are fully compliant with requirements for the Pharmacology and Toxicology Information section of the

IND.

66). In Attachment 12, roughly what percentage of work is anticipated to involve/require the use of NHPs?

Response: As is noted in the sample Task Order, four different tissue types are included in the Task Order, one of which is NHP.

67). In Attachment 12, roughly what percentage of work will need to occur in BSL-3 or BSL-4 laboratory space?

Response: TCR studies do not require high containment.

68). Can specific topics of work projects be proposed by the companies within the scope of the solicitation? For example, a new drug discovered by the company that prevents COVID disease. Or, are the work projects only supposed to be initiated by NIAID?

Response: Please proposal based on what is in the RFP.

69). In Attachment 3, General Task Order Requirements, B) Project Management, page 4; The RFP indicates the “final project plan will be available no longer than 30 days after the effective date of any Task Order Award.” Is the Project Plan required with this proposal submission? If required, where should this be included in the proposal?

Response: As all the task orders are samples and will not be awarded at this time, a final project plan is not required.

70). In Section M, 10. Evaluation of Electronic and Information Technology Accessibility, Section 508, page 146; Where should the offeror address Section 508 in the proposal submission? Can the Section 508 Evaluation Template be inserted as an attachment/appendix?

Response: Attachment 21, HHS Section 508 Product Assessment Template can be attached to the proposal.

71). On page 100, Section L, b. Technical Proposal Instructions, 4. Human Subjects; Where should the FWA be included in the proposal? Can it be inserted as an attachment/appendix?

Response: Yes, it can be inserted as an attachment.

72). On page 42, Information Security Categorization, Article H.36.1; The PII Impact Level is listed as LOW although it is indicated that there will be PII collected. Is this correct?

Response: The base contract is Low. Any task orders that have PII will have additional security requirements.

73). In Attachment 7, Sample Task Order C-1; What is the assumed holding time for NHPs in the ABSL3 following TB challenge?

Response: The assumed holding time is 3 months in ABSL3 following TB challenge.

74). In Attachment 7, Sample Task Order C-1; Does NIAID desire that vaccine candidates will protect against fulminant, latent, or both types of TB? It is unclear from the sample task order study design if the vaccine candidates will be tested for which type of TB disease.

Response: The primary goal is to test whether vaccine candidates can protect against primary progression to TB disease in rhesus macaques. A secondary goal is to establish a latency TB model in cynomolgus macaques providing an opportunity for vaccine candidates to be evaluated for: 1) Prevention of latent infection after primary Mtb challenge or 2) Prevention from Mtb reactivation or rechallenge in latently infected animals.

75). In Attachment 7, Sample Task Order C-1; Table 1 lists multiple clinical and pathological procedures that the offeror should have the capability to perform. Some of these procedures are not typically performed for TB studies. Should the proposal (technical and cost) include only those procedures applicable to the study design developed in the sample task order?

Response: Technical proposal should list all capabilities offeror can perform but can specify which procedures they feel are applicable to the TO study design and can therefore include the applicable procedures in the cost estimate.

76). In Attachment 7, Sample Task Order C-1; Will the Government confirm that Sample Task Order C-1 is non-GLP?

Response: Yes, it is non-GLP, but any capabilities for GLP studies should be included.

77). Is it expected that all potential teaming partners will be named in the proposals or can proposers assume that NIAID will allow for partnerships and subcontracts on individual task orders as need be based on scope of work and subcontracting goals?

Response: NIAID will allow for partnerships and subcontracts on individual task orders as need based on scope of work and subcontracting goals.

78). In Attachment 7, Sample Task Order C-1; This task order requires non-standard BSL-3 imaging capabilities. Will the Government accept cost proposals for acquisition of equipment to meet this requirement? Will the Government accept alternative approaches to accomplishing the same goal – assessing disease course (i.e., serial radiography)?

Response: The imaging described in the Task Order is of interest to the government. It is currently not government furnished equipment. Offeror can include in cost proposal the acquisition cost as a consideration and can provide alternative approaches in technical proposal.

79). On page 128, Business Proposal Instructions; Will the Government accept Small Business Subcontracting Goals less than the HHS statutory goals?

Response: No

80). Since the Small Business Subcontracting Plans for each Task Area require offerors to specify the Total Contract Value and Total Subcontracting Value, can the Government please provide more direction on the estimated value of all Task Orders to be released under each Task Area, to enable offerors to appropriately formulate subcontracting goal dollars and percentages?

Response: Please use the maximum ceiling amount to project the Subcontracting goals.

81). Due to the difficulties surrounding virtual work environments, will the Government issue a 3-week extension of the proposal due date?

Response: We do not currently anticipate issuing an extension.

82). In Attachment 1, Packaging and Delivery of Proposals, B. Creating and Naming Files; Will the Government clarify if proposal graphics must be searchable?

Response: Yes. Proposal graphics must be searchable.

83). In Additional Technical Proposal Instructions, Section 4 and Section 8, page 22 and 235; Can the Government clarify if the Sample Task Order response is to be part of section 4 or section 8 of the proposal?

Response: There are two sample task order in Task Area A that will need to be addressed when proposing to Task Area A. Section 8 is stating that the two sample task orders should be separate in the technical proposal and clearly identified as such.

84). In Attachment 13, Additional Technical Proposal Instructions; Where is the redundancy in the requirements; may offerors address information thoroughly once in each volume, and then within that volume, cross reference?

Response: Yes, please reference the information to reduce redundancy.

85). In Attachment 13, Additional Technical Proposal Instructions, Section 3; It is expected that this information will be duplicated across multiple task proposals. Will the Government consider letting Section 3 be submitted as an attachment or appendix to the proposal, so offerors are allowed the full 50-100 pages to address the Task Areas?

Response: Please provide the information once and reference it across the proposal

86). In Attachment 14, Section 3.1) Technical Cost Assumptions B. 7 for Task Area E-1; Please clarify that

0.15 FTEs is correct for the base; we would assume the base FTE should be at least as much for each option year. Should this read, “1.5 FTEs for the base period”?

Response: The paragraph is revised to the following:

The Base Period and Options 1-6: The required level of effort is stated in terms of Full Time Equivalents (FTEs). The labor effort includes consultants/ subcontractor labor efforts. To assist in the preparation of your proposal, the Government considers the effort to be 0.20 FTEs for the base period and 0.20 FTEs per year for option 1-6.

87). In Attachment 14, the first paragraph under this section B.7 for Task Area specifies a Base and 6 options; The text quoted above gives Options 1-5. Should that be corrected to Options 1-6?

Response: Yes, please see above response.

88). On page 94 and page 133, Past Performance Information and Qualifications of the Offeror; Would the Government please clarify the difference between past performance and general experience? Does the Government wish a separate section to include past performance and a separate section for a summary for “General Experience, Organizational Experience Related to this RFP, Performance History and Pertinent Contracts”?

Response: Yes, please address both in the business proposal.

89). In Section L, page 94, Past Performance Information; Would the Government please clarify if the five past performance references are considered inclusive of prime and subcontractor references?

Response: Yes, Offerors may submit past performance information regarding predecessor companies, key personnel who have relevant experience or subcontractors that will perform major or critical aspects of the requirement when such information is relevant to the instant acquisition. A subcontractor reference will be considered if it is a major subcontractor.

90). In Attachment 3, Base Contract Statement of Work; We assume the base period SOW is the Master Agreement at the IDIQ level regardless of awarded task area(s)? Further, we assume that no deliverables will be due at the IDIQ level. Please confirm if these assumptions are accurate.

Response: These assumptions are accurate.

91). In Attachment 3, Base Contract Statement of Work; We assume that there will be no deliverables at the IDIQ level. If not, will the Government issue an Administrative TO cover the cost associated with these activities?

Response: There are no deliverable at the IDIQ level.

92). In Task Order C-1; With regard to the C-1 sample task order SOW, it would be helpful for budgeting purposes to have additional information regarding the study design. Such information includes, the number test and control cohorts, number of animals per cohort, immunization route(s), and number of immunizations, number and type of sample collections, length of the observation time for each arm of the study, time points for PET/CT imaging, and the number and types of samples that should be shipped to NIAID, if any. In addition, it would be helpful to get clarification on if pricing proposals should include activities indicated in the C-1 sample task area SOW that do not appear to be associated with the subject TB vaccine immunogenicity and challenge study. For example, section A.7 of the C-1 sample task order SOW indicates, “Handle, and administer into NHPs, BSL-2 and BSL-3 infectious agents, including Mycobacterium tuberculosis (Mtb), simian immunodeficiency viruses (SIV), influenza viruses, and alphaviruses.” Is the intent of such statement to provide information on overall capabilities or should such activities be included in the cost proposal?

Response: “Handle, and administer into NHPs, BSL-2 and BSL-3 infectious agents, including Mycobacterium tuberculosis (Mtb), simian immunodeficiency viruses (SIV), influenza viruses, and alphaviruses.” The intent is to provide information on overall capabilities. Does not need to be reflected in the cost proposal.

93). In sample task order C-1; With regard to the C-1 sample task area SOW, we assume NIAID will provide NHPs for this study. Will NIAID also cover the costs for transportation of NHPs to and from the testing facility?

Response: For the purpose of the sample task order, NIAID will provide NHPs and will arrange for transportation for NHPs to and from facility. The requirement in the future will be outline in future task order request for proposals.

94). On page 124, Business Proposal Instructions; Would the Government please clarify if Certified Cost or Pricing Data and Data Other than Certified Cost or Pricing Data will be required?

Response: Data other than Certified Cost or Pricing data is required.

95). On page 126, Salary Rate Limitation; Does the Government intend that all salaries/labor rates are below the NIH Ex Level II salary ceiling? Can the Government confirm that any portion of the salary this is above that rate be considered as unbillable?

Response: Yes, the government will not reimburse any salary costs over the Salary Rate Limitation.

96). On page 126, Salary Rate Limitation; Would the Government please clarify if the Salary Rate Limitation is based on an annual salary and not an hourly rate?

Response: It based on an annual salary.

97). On page 126, Salary Rate Limitation; Would the Government please confirm if the offeror should adhere to the 2020 Level II $197,300 or the Freeze rate EX-II: $183,000?

Response: Please adhere to Level II salary rate limitations.

98). Is the Government able to provide information regarding a ceiling/ceiling range for each of the task areas?

Response: Each base contract award, regardless of which task area is included, the minimum is $2,000 and the maximum ceiling is $545,452,906.

99). In Attachment 6, Sample Task Order B-1, page 186; Are other fill configurations acceptable if the targeted clinical concentrations are still met with the new configuration? What is the anticipated clinical dosing concentrations for the EXV gp372-ferritin nanoparticle vaccine?

Response: For Drug Product, the fill configuration at 250 µg/mL, 0.3 mL per vial must be maintained. The vial must be suitable for long term storage at ≤ -70°C. Vials other than a 3 mL glass vial can be considered both for Drug Product and for Diluent.

100). In Section M, Evaluation Factors for Award, page 140, Live Vertebrate Animals Evaluation; Please confirm this evaluation factor only applies to task areas that require offerors responding to the applicable task orders to work with live vertebrate animals?

Response: Yes. This evaluation factor only applies to the applicable Task Areas.

101). In Section M, Evaluation Factors for Award, page 140, Evaluation of Data Sharing Plan; Please confirm this evaluation factor does not apply to Task Area A, as there is no mention of data sharing in the sample task orders A-1 and A-2?

Response: Is this a requirement of the base contract and it will be evaluated for award not withstanding which task area is proposed.

102). Attachment 3, Description for Individual Task Areas; With regard to services such as sample tracking and biorepositories, does NIAID anticipate using centralized vendors under separate NIAID IDIQ contracts to support the prime contractors under this program? (e.g. Emmes’ GlobalTrace system for sample tracking and Fisher Clinical Services (by Thermo Fisher Scientifc) Biorepository)? If yes, are there other centralized services from the 3rd party vendors that NIAID plans to integrate into these contract activities?

Response: Either under other contract vehicles or other Task Orders under this contract, NIAID may, on a Task Order specific basis, rely on third party vendors to provide some activities, materials, or services that might otherwise be included within a Task Order. Existing NIAID contracts for centralized services will certainly continue, and continue to be used, until the end of their Period of Performance (POP). Other Task Orders or contracts will almost certainly become a NIAID option during the POP for this contract. We expect this integration to be smoothly managed by all parties.

For purposes of responding, Offerors should base their responses to the sample Task Orders on the requirements as laid out in the sample TO, assuming that all requirements must be met by the Offeror either directly or by subcontracting.

103). Attachment 4, Sample Task Order A-1, page 176-177; The description of IT architecture and software indicates a local area network is needed. Can a cloud base solution meeting FISMA and FedRAMP requirements be proposed for hosting applications?

Response: Yes, a cloud base FEDRamp approved FISMA Moderate solution would be acceptable but would still require a SA&A and corresponding Security Plan that supports the agency ATO.

104). In Attachment 4, Sample Task Order A-1, page 176; Can the Government confirm that the sites will have a local pharmacy for product and necessary required storage for the interest of Sample Task Order pricing? Can the Government provide information about the proposed IP? Temperature requirements, compounding or mixing requirements, for the CRO to plan for personnel, blinding tools and appropriate equipment and administration supplies.

Response: There have been pharmacies set up for our projects and the offeror may be expected to stand up such facilities. Therefore, the offeror should be able to provide information on variety of IP’s stored at varying temps and requiring certain steps for cold chain, storage, and destruction.

105). Attachment 4, Sample Task Order A-1, page 177; Can the Government identify origination and destination of clinical trial agent(s) and specimens and quantities anticipated? Can the Government clarify whether clinical trial agent(s) and specimens will be imported into and exported out of Liberia?

Response: Please propose offerors experience and capability with importin and exporting products and samples out of Liberia.

106). Attachment 4, Sample Task Order A-1, page 175; Can the Government provide additional clarification regarding the insurance requirement? Does the Government want offerors to use a plug value for the premium costs or should we omit these costs for this sample task order? Which entity would be the sponsor as it is not clear that we could obtain clinical trials coverage if we are not conducting the trials or some part of it. Please clarify the Governments expectations regarding the offerors responsibilities with regard to contracting with the clinical sites that will conduct the unlisted study(ies) in sample Task A-1?

Response: Specific premium costs do not need to be provided, however, the offeror should state whether or not they have mechanisms in place to provide clinical trials insurance and describe how those mechanisms have been established.

107). In Attachment 4, Sample Task Order A-1, page 172; Please confirm what, if anything, will be provided by the Government in the performance of this sample task order?

Response: SME and access to existing Liberian MoH clinical sites through the NIAID/Liberia Ministry of Health partnership/ability to use government run hospitals and clinics.

108). In Attachment 4, Sample Task Order A-1, page 175-176; Is there a requirement that these services be on premise or is cloud hosted service acceptable?

Response: Please provide what would be best based on the requirements of the SOW.

109). In Attachment 4, Sample Task Order A-1, page 174; For the purposes of this sample task order, please clarify what is by “…provide the technical research support as set forth by the collaborating partners.” For the purposes of this sample task order can the Government provide additional clarification regarding the specific scientific and consulting activities that need to be conducted so offerors have the same set of understandings?

Response: The range of support could be from concept development to protocol development through to protocol implementation as well as data analysis and publication. It would be assumed the offeror would be able to provide support at any stage of the project.

110). In Attachment 4, Sample Task Order A-1, page 174, Training; For purposes of submitting an estimated level of…