75D301-25-R-73207 Amendment 0002.pdf

75D301-25-R-73207

Diagnostic Test Development and Production for Emergency Response Solicitation

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

The following has been deleted in its entirety:

SECTION C – CONTRACT CLAUSES

CDCA_H007 Subcontracting Plan (Jul 1999) The Contractor’s subcontracting plan, as negotiated, submitted in response to Solicitation 75D30124R72996, is hereby incorporated into this contract by reference.

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SECTION E – SOLICITATION PROVISIONS

E.3(b) - Volume III: Business Proposal

(c) Subcontracting Plan

The offeror, prior to being awarded a contract, must submit an acceptable subcontracting plan (see FAR 52.219-9) or demonstrate that no subcontracting opportunities exist. (Note: This requirement does not apply to small business concerns or to offers which do not exceed $700,000.00 ($1.5 million for construction) or to offers from non-domestic concerns.)

The following have been added by full text:

QUESTIONS AND RESPONSES

1. QUESTION: The acquisition identifies NAICS code 541389 - Testing Laboratories and Services with a Standard size of $19M. We are a manufacturing company with well above $19M in receipts. Is this RFP specific to testing laboratories only and not manufacturers? Do we qualify?

RESPONSE: This Contract Opportunity is not posted as a set-aside for Small Business on Sam.gov. The solicitation 75D301-25-R-73207 document attached to the Contract Opportunity post provides that this is a Commercial Products and Services competitive procurement for Full and Open Competition. Contractors may bid on a Commercial Products and Services solicitation even if their NAICS code doesn't match the one specified in the solicitation, as long as the Contractor can demonstrate that their product or service fits the solicitation's requirements. The Government is unable to decide your eligibility based anything other than a properly submitted proposal in response to the solicitation. Please read solicitation in its entirety to determine if your company is eligible and fully capable of meeting the specific requirements of the solicitation to determine if you are qualified.

2. QUESTION: We would like to know if this is a brand new contract OR if there is (was) an incumbent performing these services. If not brand new, could you please provide the current / previous contract number?

Diagnostic Test Development and Production for Emergency Response Solicitation

RESPONSE: See Amendment 0001

3. QUESTION: The Solicitation specifies that the diagnostics be performed using nucleic testing.

We use a micro-immunoelectrode-based technology which is less expensive and simpler to operate. Is CDC open to considering other technologies with sensitivity and specificity similar to qPCR?

RESPONSE: This solicitation is aimed at providing tests that run on a currently installed base of high throughput instruments in the clinical laboratory system, not for innovative point of care tests. There may be a future request for proposal (RFP) for point of care tests, but not this one.

4. QUESTION: The time from testing to results of our technology is approximately 60 seconds, and the tests are breath-based and thus non-invasive. Is this within the parameters of acceptable performance for CDC?

RESPONSE: Not for this RFP, see response for question three (3).

5. QUESTION: Our biosensors for existing or newly emerging pathogens can be developed and launched at scale approximately 4 weeks from the provision of samples of the target pathogen;

we would not require sequencing to be provided by the CDC to develop our tests, as we have developed a naive nanobody library with 1010 (ten billion) unique specificities. Is this within the parameters of acceptable performance for CDC?

6. QUESTION: The CDC indicates that the purpose of the Solicitation is “to enhance laboratory quality, science, and data reporting by improving specific laboratory processes and data sharing between internal and external partners. These enhancements should strengthen our national laboratory system to support readiness and response activities at all levels of public health and across multiple pathogen and condition types, both current and novel.” Does this include new laboratory processes in addition to existing ones?

7. QUESTION: According to the document on SAM.gov, the response due date is December 2, 2024. Could you kindly clarify what specific information should be included in our response to this RFP?

RESPONSE: Please review the solicitation and amendments attached to the solicitation for specific information that is required to be included in vendors responses for this RFP.

8. QUESTION: How does the Yearly Cost a Contractor offers in the Price Schedule relate to the pricing negotiated at the time of Request for Task Order Proposal (RFTOP)? Is the price

Contractor offers in the Price Schedule a ‘Not to Exceed/Cap’ amount but actual costs will be delineated in the individual Task Order?

RESPONSE: The prices in the IDIQ price schedule act as a "not-to-exceed" rate for labor and other costs. The actual cost for each task order is negotiated individually under the RFTOP specific requirements for that task. Contractors must ensure that their task order pricing aligns with the IDIQ pricing schedule.

9. QUESTION: Can you confirm that Contractor has the option to (1) not bid on a Task Order and

(2) not accept a Task Order that was issued under the Fair Opportunity Exceptions requirement or urgent/emergency requirement?

RESPONSE: (1) Vendors are not required to submit a proposal for in response to every request for task order proposal issued under the IDIQ contract. It is up to the vendor to decide whether to submit a proposal based on their interest, capabilities, and other factors. (2) Vendors are not obligated to submit proposals for solicitations even when the fair opportunity requirements are followed. The solicitation does not require a minimum level of participation from vendors.

10. QUESTION: Will Contractor have input on RFTOP SOWs prior to issuance?

RESPONSE: No, contractors will not have input on RFTOP SOWs prior to issuance to maintain fairness and avoid conflicts of interest.

11. QUESTION: Will RFTOPs be issued on a Line Item basis or is the intent that they will include all line items? In other words, does CDC anticipate if it identifies a certain pathogen, it will issue an RFTOP that includes all Line Items or only some (e.g. Line Item 0001, 0002, & 0003) and then issue an RFTOP for the rest of the Line Items at a later time depending on the level of need or level of urgency?

RESPONSE: The Scope of work will determine which line items are included in a RFTOP at the discretion of the government. Certain task orders will require multiple line items, while others may only include one line item. Unused line items can be used at a later date dependent on the ordering period still being valid.

12. QUESTION: When an RFTOP is issued, can Contractor bid on only some of the line items or if it is participating, does it have to bid on all line items?

RESPONSE: The task orders issued under the IDIQ are Firm-Fixed-Price (FFP), therefore the Government requires vendors to submit proposal for the entire scope of the project, including all line items (CLINs) for each RFTOP.

13. QUESTION: Is this primarily directed towards assay manufacturers vs. performing laboratories, or both? Would a submission be welcome from a high-throughput clinical lab such as ours who would rely on other third party vendors with GMP for synthesis of primers/probes, and would primarily want to perform testing in-house rather than distribute/market/ship tests to other laboratories?

RESPONSE: This is aimed at vendors who can develop, adopt, or distribute tests to multiple performing laboratories. There is a separate existing IDIQ for performing laboratories.

14. QUESTION: For Task 4, would a submission be welcome from a contractor that can produce/turnaround testing anywhere between 10,000 to >1,000,000 tests per week, or are you only looking for submissions from contractors capable of producing >1,000,000 tests per week?

Our lab had capacity to perform ~35,000 tests per week during the COVID-19 pandemic at peak, and can sustain or modestly exceed this level of testing in the next pandemic. I'm wondering whether this would be looked upon favorably, or whether the >1,000,000 number is a firm criteria.

RESPONSE: The capacity is to develop and produce test kits/materials for distribution, not run the tests. The 1,000,000/week production capacity is a requirement.

15. Our lab has experience with conducting human usability studies and FDA EUA submissions for self-collected specimens. Would the CDC potentially be interested in this type of validation expertise to be highlighted in the proposal.

RESPONSE: This experience could be useful but is not a primary goal of this solicitation.

16. QUESTION: The Schedule of Supplies/Services 000401 indicates 100,000-999,999 lot size. Task 4.b. indicates 10,000 to > 1,000,000 tests per week. The pricing table has 100,000-999,999 lot size, no time frame provided. For pricing purposes please clarify the test capacity range and time frame.

RESPONSE: The pricing is per lot in sizes of 1,000,000 to standardize for comparison. It is possible an order could be placed for a smaller number such as 100,000, in which case pricing differ per unit, or that larger orders might be placed which might result in reduced per unit cost.

You only need to submit the cost estimate for a lot size of 1,000,000. For time frame, the ability to achieve a capacity of 1,000,000 per week within one month of initiating ramp up is the target.

17. QUESTION: The overall objective is a NAAT that can be run on automated platforms. Please clarify what type of automated platform- is the contractor required to validate NAAT tests for samples coming from automated sample prep, or for automated NAAT test platforms?

RESPONSE: The vendor is responsible for validating that the NAAT test runs on an automated platform. If sample preparation is not part of the automated workflow, validation of a separate sample preparation method (automated or manual) would be up to the testing laboratory, not the vendor. If the automated platform integrates both sample preparation and running the assay (which would be considered a positive when comparing platforms), then the vendor should validate the complete process.

18. QUESTION: Please identify what is the maximum BSL level expected for pathogens under this contract? Near neighbors are very important if BSL3 or BSL4 pathogens could be expected.

RESPONSE: It is possible that high containment or select agent pathogens could be requested.

Note that diagnostic testing of unknown specimens is likely to be handled at BSL-2. For validation of high-containment pathogens, use of inactivated specimens for both sensitivity to the pathogen of interest and specificity against near neighbors is acceptable. Also note that in some cases multiplexing to detect and distinguish near neighbors may be desirable (e.g. mpox clade 1 and 2).

19. QUESTION: Does the government have a template for the Diagnostic and Validation Plans?

RESPONSE: Refer to the FDA guidance for industry here: Bioanalytical Method Validation Guidance for Industry | FDA. CDC will be available to review and discuss validation plans as part of the onboarding process, but FDA has decision making authority over what is acceptable.

20. QUESTION: Is a new Diagnostic and Validation plan required for each pathogen of interest?

RESPONSE: No – the development and validation plan will be pathogen-agnostic. It is acceptable for the plan to include statements like “specificity testing will be performed against the appropriate near-neighbors identified in collaboration with the CDC”. Pathogen-specific items like identification of near-neighbors will be needed for each pathogen, but the plan can leave those specifics to be determined after the pathogen is identified.

21. QUESTION: Are there contingency plans if a pathogen mutates significantly during test development?

RESPONSE: Given that the target timeframe for development in response to a pathogen is 30 days, we do not anticipate significant mutation that quickly. However, primer and probe design should take into account the potential for mutation, include multiple targets and select for the most conserved sequences that provide sufficient specificity. If an outbreak lasts for long enough to have significant genetic drift, it may be necessary to update a test to detect new variants over time.

22. QUESTION: For non-LDTs, will CDC provide additional background on the pathogen's epidemiology or genomic characteristics to inform planning?

RESPONSE: The CDC intends to be an active partner in method development and to provide all available information that would inform planning to the vendor(s). In the case of a new emerging disease, epidemiological and genomic information may be limited, but will be provided as it emerges.

23. QUESTION: How often will working group meetings occur, and what will the reporting cadence look like?

RESPONSE: This is open for discussion, but we anticipate monthly meetings with exchange and review of documents occurring as needed between meetings. CDC will be available for additional meetings for discussion as needed.

24. QUESTION: Can CDC provide an example of “minimum EUA validation requirements” to align working group expectations?

RESPONSE: The intent is for the working group to establish this in collaboration with FDA.

Decision authority on minimal EUA validation is subject to FDA decision. There are many examples of FDA EUA tests listed here that can be used as examples: In Vitro Diagnostics EUAs

| FDA

25. QUESTION: Are the working group meetings the only formal communications expected with CDC? No reporting is noted in the RFP aside from the kick-off and the Test Development Plan.

RESPONSE: When there is a task order issued for developing a test, communication for that test will be determined. For test development for potential future threats, the cadence will likely be monthly plus as needed. For test development in response to an outbreak, frequency will likely be at least 2 times per week and as needed to promptly address issues as they arise. During development activities informal, direct communication and collaboration between the vendor and the relevant CDC subject matter experts is expected and encouraged between formal meetings.

26. QUESTION: Will CDC require certain software or databases to be used for primer/probe selection?

RESPONSE: The vendor may use whatever software they choose. For pathogens with existing LDTs, the CDC will provide the sequences currently in use, which may enable the vendor to reference existing data for the LDT. The vendor is free to design different or additional primers and probes, although CDC reference data would not apply to them.

27. QUESTION: Are there any requirements for the methodologies? AIE, RP, CE, dual, etc?

RESPONSE: This contract is for NAAT tests that run on automated testing systems currently widely available in clinical laboratories. The size of the existing installed base is one of the selection criteria. New technologies that are not currently widely available will not be considered for this RFP.

28. QUESTION: Can CDC provide a list of current LDTs that may be requested?

RESPONSE: The intent is to use this mechanism for developing tests to pathogens of concern as they arise. In the past year, separate contracts have been issued for influenza H5 and Oropouche and Mpox Clade I. Future outbreaks are unpredictable, the primary purpose of this RFP is to set up a mechanism for rapid response to outbreaks that do not have an existing test because they were not predicted in advance.

29. QUESTION: Is the inactivated pathogen genomic material provided by CDC or produced by the contractor?

RESPONSE: If CDC has inactivated material available, it will be provided. For new emerging diseases it may be necessary for CDC and the vendor to collaborate on obtaining such material. It is possible that some vendors may have better access to international sources for specimens than CDC does.

30. QUESTION: What types of clinical specimens are going to be provided or need to be obtained?

RESPONSE: Specimen type will depend on the pathogen. Recent examples include nasal swabs for SARS-COV-2, lesion swabs for Mpox, urine for Zika, blood for Dengue. For new emerging pathogens, it may be necessary to evaluate multiple specimen types to identify which has the highest concentration of pathogen. CDC will provide all available information on specimen type selection for the pathogen. CDC will also provide information on what clinical specimens CDC is able to share for the pathogen at the time the test is requested for that pathogen to inform vendor cost and effort estimates. CDC intends to provide as much support as possible for validation specimens, recognizing that availability may be limited for new emerging or rare pathogens.

31. QUESTION: What volumes of clinical specimens can be provided? Is there a limit on the volume available?

RESPONSE: This will depend on the pathogen. CDC intends to provide as much support as possible for validation specimens, recognizing that availability may be limited for new emerging or rare pathogens. CDC may be able to provide inactivated pathogen to generate artificial specimens if needed.

32. QUESTION: If the clinical specimens are not provided by CDC, is the contractor expected to obtain them? How will access be provided?

RESPONSE: If CDC does not have available specimens to provide, the vendor will have to come up with a plan to collect clinical specimens in collaboration with CDC. CDC recognizes that specimen availability or collection need will affect development costs. The vendor may submit separate cost estimates for validation using CDC-provided or vendor-obtained specimens.

33. QUESTION: Will tests ever include probes? If yes, can a list of probe quenchers that are acceptable be provided for pricing purposes?

RESPONSE: Existing LDTs may include probes and quenchers. The vendor is not required to use the same probes or quenchers as the LDT, although changes may affect the ability to reference LDT performance data. Many LDTs use older probes and quenchers that are not used by automated platforms, the vendor is expected to use the probes and quenchers that work best on their platform.

34. QUESTION: For LDTs, could alternative probes with more accessible modifications/quenchers be designed if the CDC selection is unavailable?

RESPONSE: Yes

35. QUESTION: What metrics and thresholds are required to determine successful sensitivity and specificity optimization?

RESPONSE: See the FDA guidance for industry: Bioanalytical Method Validation Guidance for Industry. The final decision on what is acceptable is up to FDA, not CDC. In general, sensitivity and specificity will need to be as high or higher than existing predicate tests. There may be more leeway for new emerging EIDs without a predicate test, at the discretion of the FDA.

36. QUESTION: Does test validation include validation of the testing platform?

RESPONSE: Test validation would include running the test on the vendor’s selected platform(s).

If a testing laboratory wants to run the test on a different platform than the vendor’s, validation of 3rd party platforms would be the responsibility of the testing laboratory, not the vendor.

37. QUESTION: What will the process be if CDC-provided specimens are unavailable for validation?

RESPONSE: The vendor and CDC will collaborate to develop a plan for clinical specimen collection. The CDC recognizes that this will represent an additional development cost. Details will depend on the nature of the pathogen and outbreak.

38. QUESTION: Are artificial specimen validation methods (e.g., spiked samples) an acceptable alternative in all cases?

RESPONSE: True clinical specimens are preferred when available. Artificial specimens are generally acceptable for determining limits of detection, and may be acceptable for other aspects of validation when clinical specimens are unavailable. Final decisions on what specimens are acceptable for validation are made by the FDA.

39. QUESTION: Can synthetic materials be used for the positive control?

RESPONSE: Final decision on acceptance of controls is up to FDA, but artificial positive controls are used in many currently approved tests.

40. QUESTION: Will CDC or FDA provide a template or guidance for the validation report?

RESPONSE: Refer to the FDA guidance for industry here: Bioanalytical Method Validation Guidance for Industry | FDA. CDC will be available to review and discuss validation plans as part of the onboarding process, but FDA has decision making authority over what is acceptable.

41. QUESTION: Is it a requirement that the existing installed base of automated, high-throughput NAAT testing equipment be only in the U.S. public health laboratory system and/or the U.S.

private clinical laboratory space?

RESPONSE: The primary focus is on the U.S. private clinical laboratory space. Presence in the public health laboratory space or any other laboratory that provides testing capacity to the U.S.

population also is desirable. Presence outside the U.S. is not required, but is not a barrier.

42. QUESTION: Is the test manufacturer required to have an existing installed base of automated, high-throughput NAAT testing equipment in the U.S. public health laboratory system and/or the U.S. private clinical laboratory space? How is this relevant to kit production and validation?

RESPONSE: The manufacturer does not necessarily have to have an installed base of their own equipment, but the kit must be compatible with an installed base of high-throughput automated systems. The intent is for the test to be run on high-throughput automated systems, not for a manual method. Kits that run on 3rd party automated systems are acceptable. Validation will require demonstrated performance on the intended platform, whether the platform is produced by the same vendor or a 3rd party.

43. QUESTION: The solicitation calls for a lead time of less than 1 month during a surge response.

What is the average non-surge lead time expected for scale-up?

RESPONSE: The expectation for non-surge would be a target of 6 months, with a maximum of 1 year.

44. QUESTION: Regulatory Submission Right of Reference: Will CDC assist in facilitating communication with FDA for regulatory queries?

RESPONSE: CDC will participate and assist with FDA queries, while recognizing that FDA has final decision making authority on regulatory approval.

45. QUESTION: What are the detailed post-market monitoring expectations? Are these tasks to be performed solely by the contractor, or in partnership with CDC?

RESPONSE: Post-market monitoring will be up to the vendor, as required by FDA. CDC will be willing to share disease surveillance data collected using the test to support the vendor.

46. QUESTION: What are the expected timelines for EUA or 510(k) submissions post-validation?

RESPONSE: The timeline for submission will be to submit as soon as possible once Task 3 is initiated. FDA approval of the submission will depend on FDA review and whether they have questions. Note that EUA submission will only be requested in response to an outbreak where there is a declared emergency. 510(k) submission would be required in the absence of an emergency, but is less likely to be requested under Task 3.

47. QUESTION: What information is needed for the validation data package? There is much more information required for a 510K/EUA submission than the data package.

RESPONSE: We anticipate the most likely scenario for initiating Task 3 is in response to an outbreak with a declared emergency, which would fall under EUA. 510(k) would be required in the absence of an emergency, which is less likely to trigger Task 3. It is in the contract as an option in case there is concern about an international outbreak that has not yet reached the U.S.

CDC understands that the price estimate for a 510(k) submission may be different than for an EUA, you may submit 2 different estimates. The vendor also has the option to submit a developed test for 510(k) on their own if they perceive a potential market for it in a non-emergency situation. This contract does not prohibit submission on your own in the absence of a task order, although the contract will not provide funding in that case.

48. QUESTION: Who is the owner of the test for FDA submission? If it is CDC’s LDT neither ATCC or Qiagen can be the owner of the test. If we develop (not LDT) is ATCC/Qiagen the owner? Usually CDC does not allow anyone else to be the owner of their tests.

RESPONSE: If CDC has a predicate LDT, CDC will retain ownership and regulatory responsibility for the LDT. It is anticipated that the automated version developed by the vendor will require enough changes (potential changes in chemistry, fluorophore/quencher, cycle conditions, etc.) to require a separate authorization from FDA. CDC will allow right of reference to predicate test data if that facilitates FDA review, but the vendor will own the automated test and have regulatory responsibility for it, whether it is based on a predicate LDT or developed from scratch by the vendor (e.g. for a new EID with no predicate test).

49. QUESTION: Will CDC notify when a kit is needed and then it will be made and distributed accordingly, or is there an expectation for it to be made ahead of time and stored until it is needed?

RESPONSE: The vendor may make, store, or sell the kit on their own ahead of an order for Task

4. The contract does not require a standing inventory. The vendor is expected to maintain sufficient raw materials and supplies to respond to an order for Task 4 in the required timeframe (production capacity of 10,000/week within 1 week with ability to ramp up to 1,000,000/week within 30 days).

50. QUESTION: Will CDC expect the kits to include PCR enzymes? Inclusion of enzyme affects shipping/storage conditions of the kits.

RESPONSE: The kits should ideally include everything needed to run the test. It may be acceptable to require some third party reagents, but if critical reagents such as master mix are not included, this may considered a risk for supply chain bottlenecks which were an issue during the COVID response, so third party requirements should be kept to a minimum.

51. QUESTION: For pricing purposes, what is the expected shipping temperature of the kits?

RESPONSE: The expectation is for the vendor to establish the stability requirements for shipping and storage. Conditions should be the same as for existing tests on your platform.

52. QUESTION: For pricing purposes, what is the expected number of reactions per kit?

RESPONSE: Pricing is requested per test in lots of 1,000,000 tests, where 1 test produces a result for one patient specimen. It is up to vendor to determine how to optimize the kit size within that for their platform (e.g. # specimens/plate, # plates/kit, vial sizes for controls and reagents, etc.).

53. QUESTION: Would large productions of 1,000,000 tests per week be expected as all one lot?

RESPONSE: Lot size is up to the vendor to optimize for their production line. A single lot of 1,000,000 would be acceptable, as would 10 lots of 100,000, etc., so long as total production capacity is sufficient.

54. QUESTION: A FIPS 199 Assessment that shows overall impact as moderate however integrity is checked as high. Please clarify if this a high or moderate impact solicitation.

RESPONSE: This is not a high impact solicitation.

55. QUESTION: What data will the contractor receive that will be CUI under EO 13556?

RESPONSE: Potential CUI info would include primer and probe sequences, possibly some of the pathogen sequence information, any other information about the test that could potentially enable a malicious actor to modify a pathogen to avoid detection.

56. QUESTION: The solicitation requires a FedRAMP compliant ATO, but does not specify a system. What systems will the contractor operate on behalf of the federal government for this solicitation?

RESPONSE: We do not anticipate any cloud-based systems as part of this contract, the FedRAMP compliance language is standard for all contracts.

57. QUESTION: Can the font size for graphics/tables be reduced to 8 pt?

RESPONSE: No. Text shall be no smaller than 12-pitch.

58. QUESTION: Are contractors required to bid on all tasks in the solicitation?

RESPONSE: Yes, contractors will be required to bid on all tasks to be considered responsive.

59. QUESTION: Can the page count for the Volume I Management Plan be increased to adequately address all CDC’s requirements?

RESPONSE: No, vendors will have to adequately address all requirements for the volume management plan while not exceeding the three (3) page maximum.

60. QUESTION: Are there small business requirements?

RESPONSE: If a vendor is a large business, they are required to submit a small business subcontracting plan. If a vendor is a small business, no subcontracting plan is needed.

61. QUESTION: Is a small business plan required in the business volume?

RESPONSE: If a vendor is a large business, they are required to submit a small business subcontracting plan. If a vendor is a small business, no subcontracting plan is needed.

62. QUESTION: The business proposal requires a contract form found in part I, section A of the solicitation. Is this the first page of the solicitation?

RESPONSE: Yes, this is the first page of the solicitation.

63. QUESTION: What performance metrics or milestones will be used to assess contract fulfillment?

RESPONSE: Milestones or deliverables will be negotiated between the vendor and contracting officer for performance based payments at the task order level.

64. QUESTION: What level of detail is needed for a subcontractor response in the business volume?

RESPONSE: A proposal should include sufficient detail about subcontractor costs in their price proposal to substantiate the overall pricing as fair and reasonable. They may include but are not limited to the following: 1. Summary of Subcontractor Costs, 2. Subcontractor Cost Breakdown,

3. Indirect Rates and Profit, 4. Basis of Estimate and Supporting Documentation, 5. Cost/Price Analysis Certification, 6. Compliance and Justification, and 7. Rationale for Subcontractor Selection.

65. QUESTION: Due to the holiday, would you be open to extending the question period and due date or at a minimum, the question due date?

RESPONSE: At this time there will not be another amendment issued to extend the solicitation questions or proposal submission dates.

66. QUESTION: Is Task 1 expected to be repeated/revised on a per task order or is it 1 for the entire program for a single pathogen?

RESPONSE: Task 1 is for the entire duration of the program, Tasks 2-4 are expected to be repeated for each new pathogen.

67. QUESTION: What are the expectations for timing for the award?

RESPONSE: Award is expected in February 2025.

68. QUESTION: Are there any examples of data exchange mechanisms that are expected through this contract? Are we expected to use Fedramp?

RESPONSE: Methods for data exchange will be determined as part of Task 1. It is likely that e-mail or secure FTP may be sufficient for the purposes of this solicitation. If a cloud-based system is proposed, it will need to be FedRAMP compliant at low baseline. Data exchange is expected to include pathogen sequences, primer and probe sequences, protocols, and analyzed development and validation results. No personal health information or personal identifiers will be included.

69. QUESTION: Are the data exchange mechanisms in relation to development data or patient testing data?

RESPONSE: Development and validation data only, no patient data will be included as part of this solicitation.

70. QUESTION: Can the term “automated platforms” be defined? What part of the platform needs to be automated?

RESPONSE: Automated platforms are ones where the operator loads specimens and reagents then the instrument conducts the procedure with minimal operator intervention. The system should integrate extraction, although it is possible that the testing procedure may span 2 instruments (e.g. one for extraction, one for amplification and signal detection).

71. QUESTION: Can the contractor pick the workflow elements such as instruments and software for validation

RESPONSE: Yes, the contractor is responsible for platform selection.

72. QUESTION: Will CDC expect the contractor to follow a primer and probe design and chemistry?

RESPONSE: CDC will share primer and probe information, and will allow right of reference to CDC data if they are used. Contractor may change any aspect of the assay design they deem necessary to optimize it for their platform, however FDA may no longer consider CDC reference data to be applicable if the changes are significant.

73. QUESTION: Is CDC open to discussing any technical limitations with assay design if it arises?

RESPONSE: Yes, contractors are encouraged to fully review the method and propose changes if they deem them needed for their platform.

74. QUESTION: Does the contractor need to provide assay sequences to the CDC?

RESPONSE: Yes, CDC will need to know the sequences for purposes of tracking test evasion by potential pathogen variants.

75. QUESTION: For non-CDC assays, is the understanding from the CDC that the contractor is expected to have rights to IP on the assay design?

RESPONSE: Yes.

76. QUESTION: For Task 3: Will CDC facilitate the discussions with the FDA? How will any additional costs be covered if they arise during the 510K process

RESPONSE: CDC can participate in discussions with FDA to facilitate, while recognizing that final decision authority lies with FDA. The determination to do so will be made on a case by case basis. The necessity for additional costs will be reviewed and

77. QUESTION: Do the subcontractors (such as partners required for clinical validation) have to be identified/ named in the response to the bid RFP at this time or can they be identified at the time of the task order response?

RESPONSE: Subcontractors can be identified when needed.

78. QUESTION: What are the expectations for the experience of the contractor with IVD submissions?

RESPONSE: The contractor should have previous approved IVD tests on the proposed platform.

79. QUESTION: How is the CDC expecting the contractor to respond to a task order for any prospective clinical studies required for a 510K as there might be uncertainty in costs and timeline due to availability of samples?

RESPONSE: For the initial submission, the contractor may submit two estimates for cases where validation specimens are provided vs. if they must be collected as part of the costs. When a task order is solicited for Task 2, CDC will provide any information at the time on the availability of validation specimens to facilitate contractor cost estimates.

80. QUESTION: For Task 4: How is the contractor expected to handle labeling requirements for a regulated product?

RESPONSE: Labeling requirements will be part of the submission to FDA and must meet with FDA approval. CDC can collaborate in discussions with FDA on the labeling, but final authority lies with the FDA.

81. QUESTION: Will the contractor maintain the design history file?

82. QUESTION: For Task 4: Will post market monitoring be self funded by the contractor?

83. QUESTION: For Task 4: Will the contractor be the Manufacturer on the record?

84. QUESTION: Is the expectation that the labs that CDC identifies to conduct testing will procure instruments and software per validation requirements?

RESPONSE: Testing laboratories will be expected to run the test in accordance with its instructions for use, which would include instruments and software. Whether they do so on existing instruments or purchase additional ones will be up to the testing laboratory. Note that part of the contractor selection process is to have an installed base of instruments and software already in the clinical testing laboratory system.

85. QUESTION: How will the contractors be measured for performance?

RESPONSE: Time to complete development and validation, test production volume and time to ramp up test production.

86. QUESTION: Can the contractor choose not to accept a task order?

RESPONSE: Once the IDIQ is awarded, vendors can choose to submit a No Bid on task order requests for proposals.

87. QUESTION: How does this IDIQ relate to and differ from the earlier IDIQ, Solicitation No.

75D30124R72996?

RESPONSE: 75D30124R72996 is for Test Surge and Data Sharing. This solicitation is for the production of actual tests.

88. QUESTION: Given the similarities and differences, will awardees under IDIQ, Solicitation No.

75D30124R72996 be considered and eligible for awards under this IDIQ?

RESPONSE: Yes if they meet all of the requirements of the new solicitation.

89. QUESTION: Scope of Validation for Regulatory Submission: Based on scope of work for Validation of clinical performance for a target pathogen (Task 2 and Task 3), is the expectation to have a EUA and 510(k) [or de novo submission] and are not anticipating a CLIA-waiver designation for the Cepheid NAAT?

RESPONSE: The primary target is EUA submission, but this will depend on an emergency being declared. A 510(k) would be needed in the absence of an emergency declaration. CLIA waivers are determined by the FDA, contractors are encouraged to request one if their platform and test design meet the FDA requirements for it.

90. QUESTION: Scope of oligo design modification for Regulatory Submission: 1.Based on the scope of work for assay development for a target pathogen, is it acceptable to modify oligo design provided by CDC to meet the performance requirement for a given sample type and/or Cepheid’s manufacturing capabilities? 2. Will CDC provide IP clearance for the oligo designs?

RESPONSE: CDC will share oligo design for a CDC assay if one exists, and allow right of reference to CDC data. The contractor is free to modify any aspects of the test they deem necessary to run on their platform (sequences or chemistry), however changes may make the CDC reference data no longer applicable. The contractor will own the IP on any changes they make for their platform.

91. QUESTION: The Solicitation provides that responses to Requests for Task Order Proposals “shall also include a budget detailing the cost of each major subtask identified within the proposal.” (p. 37). Will eligible awardees be allowed to deviate from their original Price Proposal in responding to future Requests for Task Order Proposals?

RESPONSE: No. Pricing structure will remain in place for the duration of the contract period of performance unless the change is mutually agreed upon.

92. QUESTION: Is the prime contractor able to use open architecture platform(s) and reagents) instead of a dedicated, specific partner, subcontractor, or vendor?

RESPONSE: Yes, but they should specify what platforms would qualify in order to evaluate the installed base.

93. QUESTION: Is it correct to assume that diagnostic tests approved under an Emergency Use Authorization (EUA) by the FDA do not need to be manufactured under Good Manufacturing Practices (GMP)?

RESPONSE: FDA has the option to waive GMP for EUA tests, but it is at their discretion and not a guarantee. See Emergency Use Authorization of Medical Products and Related Authorities |

FDA.

94. QUESTION: Is it correct to assume that all diagnostic tests approved under 510(k) by the FDA must be manufactured under Good Manufacturing Practices (GMP)?

RESPONSE: FDA determines whether GMP is required. They have the option to exempt a test from GMP, but it is required for most diagnostic tests.

95. QUESTION: Does the CDC allow for a negotiation phase after a proposal has been selected by CDC? Are any terms negotiable after submission if a proposal is selected for further consideration?

RESPONSE: The potential for negotiation may be available at the task order level but is not guaranteed.

96. QUESTION: Are there templates available for technical and business proposals that CDC prefers to use?

RESPONSE: No. The only template available is the pricing structure provided as an excel spreadsheet.

97. QUESTION: Does the business proposal pertain only to items fulfilled in this contract or the broader commercialization of a product that is developed under this project?

RESPONSE: Only to items fulfilled in this contract.

98. QUESTION: On page 69, under the “Volume 1: Technical/Management” section, the RFP outlines the requirement for the Offeror to describe their organizational structure. Is the organizational structure requirement intended to be specific to this project, or is the CDC requesting an overall entity organizational structure?

RESPONSE: It is the overall entity organizational structure. If you intend to put additional structure in place for this project you may indicate where it would sit in your current structure.

Part of Task 1 will be to identify project leads and points of contact, it is not necessary to do so as part of the initial application.

99. QUESTION: Does the agreement with CDC allow for collaboration in determining the specific pathogen identified for test development and production, or is it at the sole discretion of CDC?

RESPONSE: Pathogens may be selected in advance of an outbreak or in response to an outbreak.

Task orders triggered by an outbreak will be for the pathogen causing the outbreak. CDC may be open to suggestions for pathogens of concern to develop tests in advance of an outbreak, but may have specific ones identified by CDC as well.

100. QUESTION: Does the agreement with CDC allow for collaboration with the awardee to determine ramp time and number of tests produced per week, or is it at the sole discretion of the

CDC?

RESPONSE: Ramp time and number of tests for the task order will be determined by the size and expected growth rate of the outbreak, and available dedicated response funding. If the contractor anticipates a larger market than the CDC task order, they are free to produce and sell additional tests separately from the task order.

101. QUESTION: Regarding Task 4, does the funding within this contract cover the cost of these tests for the labs that they will be distributed to, or is the expectation that the Contractor will also commercialize and sell the tests? If the contractor is responsible for marketing these tests, does that also mean the contractor is responsible for determining the market price of these tests?

RESPONSE: The size of the CDC task order will be determined by the size and expected growth rate of the outbreak, and available dedicated response funding. If the contractor anticipates a larger market than the CDC task order, they are free to produce and sell additional tests separately from the task order.