Amendment_No._1_-_PHS-2023-1.pdf

AMENDMENT ONE (1)

Solicitation Number: PHS 2023-1

Date of Solicitation Issuance: 08/08/2022

Date of Amendment No.1 Issuance: 09/30/2022

Number of Pages: 14

Points of Contact:

George Kennedy, Contracting Officer E-mail: kennedyg@mail.nih.gov

Cherie Wells, Contracts Analyst (Contractor) E-mail: ncioasbir@nih.gov

ISSUING OFFICE OF ACQUISITIONS

National Institute of Allergy and Infectious Diseases (NIAID) 5601 Fishers Lane, Suite 300, MSC 9821 Rockville, MD 20852

PURPOSE OF SOLICITATION AMENDMENT

The purpose of this amendment is to:

- Provide slides, recording, and transcript of the pre-proposal conference; and,

- Respond to Questions received regarding the solicitation.

The hour and date specified for receipt of Offers remains unchanged.

Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full effect.

A recording of the pre-proposal conference and associated materials have been posted on the NIH SBIR/STTR SEED web page, and are also made available below:

• Webinar Slides

• Recording

• Transcript

General Solicitation Questions

Question 1: Is a company allowed to submit more than one proposal to the same topic, assuming the proposals represent clearly different approaches, under the PHS 2023-1 SBIR Contracts solicitation?

Answer 1: Yes, a company is allowed to submit more than one proposal under the same topic, if the proposals represent separate and distinct projects.

mailto:kennedyg@mail.nih.gov mailto:ncioasbir@nih.gov https://seed.nih.gov/events/20220824/hhs-contracts-solicitation-webinar-phs-2023-1-materials-available https://seed.nih.gov/sites/default/files/2022_HHS_SBIR_Contract_Webinar_PHS-2023-1_Slides.pdf https://seed.nih.gov/sites/default/files/2022_HHS_SBIR_Contract_Webinar_PHS-2023-1_Slides.pdf https://www.youtube.com/watch?v=A3iVhGRQK9E&list=PLOEUwSnjvqBKRmdZKqCztNYDQCufyKMEP&index=2 https://www.youtube.com/watch?v=A3iVhGRQK9E&list=PLOEUwSnjvqBKRmdZKqCztNYDQCufyKMEP&index=2 https://seed.nih.gov/sites/default/files/HHS-SBIR-Contract-Solicitation-Webinar-PHS-2023-1-Transcript.pdf https://seed.nih.gov/sites/default/files/HHS-SBIR-Contract-Solicitation-Webinar-PHS-2023-1-Transcript.pdf

Note that for proposal submission in eCPS, the company would need to create entirely separate submission packages. The company would go through the eCPS submission process for the 1st submission and then repeat the process for the next submission. If a company is planning to submit more than one proposal under the same topic, it is recommended that the Company differentiates between their different Phase I proposals by using a unique identifier in the file names/naming conventions. For example: if each submission has a different PI, include the PI name in the submission file names, etc., to ensure reviewers will be aware that the submissions are different proposals from the same vendor not a duplicate submission of the same proposal.

Question 2: If a small business is planning to submit an SBIR application in response to the omnibus SBIR

FOA, will that small business be allowed to submit the same set of research aims to this SBIR contract solicitation (PHS-2023-1) with the intention that if both are awarded, the applicant will accept only one award?

Answer 2: An offeror is permitted to submit to one, but not both. A small business concern may not submit both a contract proposal and a grant application for essentially equivalent work in response to multiple NIH/CDC SBIR solicitations and funding opportunity announcements. (The only exception is that a grant application is allowed to be submitted after a contract proposal has been evaluated and is no longer being considered for award.)

It is permissible, with proposal notification, to submit proposals containing essentially equivalent work for consideration under another federal program solicitation in addition to one NIH/CDC solicitation or funding opportunity announcements for the SBIR program.

Question 3: If an offeror has a grant application that may be funded soon, with overlapping aims for some of the deliverables in the SBIR contract Topic, can the offeror submit a proposal for the SBIR contract to be funded, excluding the aims that are already funded by a grant?

Answer 3: Please refer to solicitation Section 4.14 ‘Prior, Current, or Pending Support of Similar Proposals or Awards’:

A small business concern may not submit both a contract proposal and a grant application for essentially equivalent work (see definition in Section 3.1) in response to multiple NIH/CDC SBIR solicitations and funding opportunity announcements. The only exception is that a grant application is allowed to be submitted after a contract proposal has been evaluated and is no longer being considered for award.

It is permissible, with proposal notification, to submit proposals containing essentially equivalent work for consideration under another federal program solicitation in addition to one NIH/CDC solicitation or funding opportunity announcements for the SBIR program. The small business concern must make appropriate disclosures within Appendix A and Appendix C.

IMPORTANT – It is unlawful to enter into contracts or grants requiring essentially equivalent effort.

If there is any question concerning prior, current, or pending support of similar proposals or awards, it must be disclosed to the soliciting agency or agencies as early as possible.

Question 4: Can you clarify when letters of support are requested?

Answer 4: When a subcontractor or consultant collaborator is proposed, a letter must be included from each individual confirming his/her role in the project and extent of involvement; when facilities other than those of the applicant are proposed, a letter must be included stating that leasing/rental arrangements have been negotiated and will be available for the use of the SBIR applicant; and, for Phase II proposals under a Fast Track submission, letters should be included in the Finance Plan section of your Commercialization Plan.

In addition, some of the specific Topic Descriptions in Section 12 refer to additional and/or more specialized letter requirements, so check your individual Topic of interest carefully.

All of these letters should be included in your Technical Proposal to ensure that they are reviewed by all reviewers.

In addition, costs associated with collaborators should be addressed in Appendix C of the Business Proposal, and letters that discuss or confirm financial information for collaborators can also be included in the Business Proposal to support the evaluation of the proposed project budget. For NIH Topics, please note that information submitted in the Business Proposal, however, will not be seen by all evaluators, some of whom will only review the Technical Proposal.

Question 5: Are there detailed guidelines for the Technical Proposal preparation, such as elements included in the 50 pages of Item 1?

Answer 5: Specific information regarding page limitations is available in solicitation Section 7.3 ‘Limitation on the Length of the Technical Proposal’.

Question 6: How should I determine and document indirect rates?

Answer 6: The solicitation allows for small business to charge indirect costs at a rate of up to 40% of total direct costs without requiring that the small business negotiate an indirect rate agreement with the NIH Division of Financial Advisory Services (DFAS).

However, this does not mean that an indirect rate of 40% will be acceptable for every business.

Your business should complete a table such as the one found at the website below to be able to justify your rate (of up to 40%), and include this information in your Business Proposal:

- https://oamp.od.nih.gov/dfas/indirect-cost-branch/indirect-cost-submission/indirect-cost-definition-and- example

After reviewing the DFAS website above, if you have further questions, you are encouraged to contact the DFAS staff at dfas-idc@nih.gov for assistance in understanding how to determine an appropriate indirect rate.

Question 7: How do we obtain a copy of a funded SBIR contract proposal as an example?

Answer 7: NIH does not have a copy of a funded SBIR contract proposal as an example.

Question 8: In general, how guaranteed are the funds stated in the topics?

Answer 8: NIH/CDC will not fund a proposal for more than the budget listed for each topic (with the exception of potential Technical and Business Assistance funding, as described in that section of the solicitation).

The Agency is under no obligation to fund any proposals or any specific number of proposals in a given topic.

Question 9: Are contracts eligible for Technical and Business Assistance (TABA)?

Answer 9: Section 4.16 provides guidance on State Assistance and Technical Assistance. NIH offers distinct technical assistance programs to NIH SBIR and STTR Phase I and Phase II awardees. These programs offer specialized, strategic business training and provide access to a vast network of industry experts which is made possible by the efficiencies of scale accomplished through providing this service through the Government.

Note for CDC offerors: CDC does not participate in the NIH TABA Program. If you are a CDC offeror and wish to utilize your own technical assistance provider, you are required to include these costs in your budget and to provide a detailed budget justification. You may request up to $6,500 per year for a Phase I and up to $50,000 per Phase II project (across all years) for assistance.

Refer to Section 8 for how to include this in your Pricing Proposal. Please note, if funds are requested to utilize your own technical assistance vendor and an award is made, the awardee is not eligible to https://oamp.od.nih.gov/dfas/indirect-cost-branch/indirect-cost-submission/indirect-cost-definition-and-example https://oamp.od.nih.gov/dfas/indirect-cost-branch/indirect-cost-submission/indirect-cost-definition-and-example https://oamp.od.nih.gov/dfas/indirect-cost-branch/indirect-cost-submission/indirect-cost-definition-and-example mailto:dfas-idc@nih.gov apply for the NIH-provided technical assistance program for the phase awarded.

Question 10: Is TABA support included in the 12-month project cost, or is this contract support an additional indirect cost?

Answer 10: The amount proposed for technical and business assistance should be clearly identified in Other

Direct costs in Appendix C, within the limits and with supporting information identified in solicitation section 4.16.

Refer to Section 8 for how to include this in your Pricing Proposal. Please note, if funds are requested to utilize your own technical assistance vendor and an award is made, the awardee is not eligible to apply for the NIH-provided technical assistance program for the phase awarded Note for CDC offerors: CDC does not participate in the NIH TABA Program. If you are a CDC offeror and wish to utilize your own technical assistance provider, you are required to include these costs in your budget and to provide a detailed budget justification. You may request up to $6,500 per year for a Phase I and up to $50,000 per Phase II project (across all years) for assistance.

Question 11: Are contracts eligible for a diversity supplement?

Answer 11: No, that program is not applicable to Federal contracts.

Question 12: Can a new corporation apply for a direct-to-phase II contract using the results of the previous

LLC? The team and resources remain the same, the company structure and name are the only changes.

Answer 12: There should not be an issue with changing company structure. https://www.sbir.gov/faqs/all states:

What happens if we change our corporate structure and change our EIN or DUNS number, are we considered new company or existing company?

If you change your corporate structure, EIN, or DUNS, you would add a new record to the already existing company for data and recordkeeping purposes.

Question 13: Are you able to provide the contact information for the program managers/contract officers for the different Topics?

Answer 13: All inquiries must be addressed to Contracting Office personnel, as set forth in Section 10 of the solicitation.

Question 14: Are the contract topics ever repeated? In case a company is unable to apply before the deadline, would there be another opportunity to apply for a similar topic?

Answer 14: An SBIR contract topic may or may not be repeated in future years. If the topic of interest is not repeated, applicants may consider to apply for the SBIR/STTR Omnibus solicitations. Link:

https://seed.nih.gov/sites/default/files/HHS_Program_Descriptions.pdf.

Question 15: If a company receives a Fast-Track award, what requirements - if any- does an awardee have to meet in order to progress from Phase I to Phase II?

Answer 15: A Fast Track submission may result in award for Phase I with a contractual option for Phase II. The

Government is not obligated to fund the Phase II portion unless and until the awarding HHS Component exercises that option. Performance requirements are specific to each contract, and will be addressed by the awarding component’s Contracting Officer for proposals identified for negotiation.

Question 16: Are foreign collaborations, in the form of either consulting or subaward agreements, allowed on https://www.sbir.gov/faqs/all https://seed.nih.gov/sites/default/files/HHS_Program_Descriptions.pdf an SBIR contact? Do they require specific justifications or documentation?

Answer 16: Please refer to solicitation Section 4.2: ‘Offeror Eligibility and Performance Requirements’.

Question 17: Would NIH consider a proposal from a company with an employee on staff whose annual salary exceeds the stated limit of $203,700?

Answer 17: Having an employee on staff whose annual salary exceeds the salary rate limitation identified in solicitation section 5.19 does not prohibit you from submitting a proposal. The salary rate limitation limits the portion of that salary that may be paid with contract funds.

Question 18: Does the salary rate limitation only apply to employees who will be actively participating in the proposed effort and billing time to it?

Answer 18: That is correct. The salary rate limitation identified in solicitation section 5.19 limits the portion of an employee’s salary that may be paid with contract funds.

Question 19: If an offeror proposes a project participant whose salary exceeds the limit, but the project funds only pay for part of their time—e.g. if they spend only 25% of their time on the project and 25% of their salary is below the stated limit, would that be acceptable under the provisions of section 5.19?

Answer 19: The salary rate limitation identified in solicitation section 5.19 does not restrict the salary that an organization may pay an individual working under an HHS contract or order; it limits the portion of that salary that may be paid with contract funds.

Question 20: Is it permissible for a contract proposal to include videos, embedded in a pdf file, as “related research or R&D”?

Answer 20: No. Technical reviewers will base their conclusions only on information contained in the proposal.

Proposals shall not include audio or video files of any type.

Question 21: Is the Phase I project possible to do over 12 months with the same budget, or does it have to fit in the 12-month timeline?

Answer 21: Phase I contract values and project periods vary among Topics. It is therefore important for proposing firms to review the Topic description in Section 12.0, which includes a Budget and Project Period for each Phase of each Topic. It is strongly suggested that proposals adhere to the specified budget amounts and project periods. Proposals with budgets exceeding the above amounts and project periods may not be funded.

Question 22: How many pages does this contract expect for the “Potential Commercial Applications” in the

Content of Technical Element (Item 1)?

Answer 22: Specific page requirements are not identified for individual elements of the Research Plan described in solicitation section 8.8. Please refer to Section 7 ‘Proposal Submission’, and Section 8 ‘Proposal Preparation and Instructions’, and exercise your professional judgement when preparing your proposal.

Question 23: Section 5.17 (2) reads “Agencies are released from obligation to protect SBIR data upon expiration of the protection period except that any such data that is also protected and referenced under a subsequent SBIR award must remain protected through the protection period of that subsequent SBIR award.” Does this mean that the agency will make the SBIR data and technology available to the public following the protection period of no less than four years?

Answer 23: As stated in solicitation section 5.17, SBIR data must remain protected through the protection period of the subsequent SBIR award.

Question 24: Section 5.18 states “Small business firms normally may retain the principal worldwide patent rights to any invention developed with Government support. The Government receives a royalty-free license for its use, reserves the right to require the patent holder to license others in certain limited circumstances, and requires that anyone exclusively licensed to sell the invention in the United States must normally manufacture it domestically.” Does this mean that all government agencies receive a royalty-free license, or is it limited to the contracting agency/IC?

Answer 24: It is not limited to the contracting agency/IC.

Question 25: I am planning to submit a Direct to Phase II proposal. Can you please clarify the differences in the elements needed in a Phase II submission vs. a Phase I submission?

Answer 25: Please refer to solicitation Section 8.4 ‘Phase II Proposal Instructions’, for information regarding

Phase II proposal’s (either as part of a FAST TRACK or Direct to Phase II).

Questions: Section 12 Component Instructions and Technical Topic Descriptions

NATIONAL CANCER INSTITUTE (NCI)

National Cancer Institute (NCI), Topic 446: Development Of Senotherapeutic Agents For Cancer Treatment

Question 1: Would the development of senolytic cell therapy fall within the scope of topic 446?

Answer 1: This would likely be within the scope of the topic.

National Cancer Institute (NCI), Topic 447: Non-invasive Device Technology Research & Development for Chemotherapy-Induced Peripheral Neuropathy Management

Question 1: What are examples of the following activity: "Conduct studies to evaluate and test user acceptability and feasibility in intended use populations”?

Answer 1: The goal is to elicit testing in the target population i.e. cancer survivors, which includes disproportionately older people; an example would be to ensure that whatever technology is developed is manageable by them. Measures might include adherence and usage frequency of a device, and customer satisfaction measures in addition to efficacy.

National Cancer Institute (NCI), Topic 449: Wearable Technologies to Facilitate Remote Monitoring of Cancer Patients Following Treatment

Question 1: The topic says that “Engage user testing with at least 30 patients utilizing the wearable monitoring device(s) and at least 3 distinct clinical care teams working with those patients (no members of any one clinical care team can be part of any of the other clinical care teams, to ensure a diversity of “real world” testing demonstrations).” Can the offeror have the care teams be in different departments in the same site or would this be non responsive?

Answer 1: The “3 team” count allows teams working at the same institution, so long as they are still different teams.

Question 2: We have a very good engineering/technical team, however we are having trouble finding a clinical collaborator. Could that be part of our Phase I proposal to identify the clinical team and collect preliminary data?

Answer 2: Per RFP, original intent was that the offerors would identify their clinical collaborators in their proposals: Activities not responsive to announcement:

“Tools that don’t focus on an identified clinical cohort and associated treatments with at least some assessment of adverse event risks relevant to those patients that could be monitored with the identified wearable technology(s) proposed; approaches that seek to address cancer prevention or early detection of cancer; and applications from teams that don’t include clinical collaborators or lack relevant technology development expertise.”

National Cancer Institute (NCI), Topic 451: Rapid and Affordable Point-of-Care HPV Diagnostics for Cervical Cancer Control

Question 1: In the description of project goals, it states “The device should enable rapid detection and genotyping for HPV”. Is “genotyping” the must have function for the device applicant proposed? Would a device that enables rapid detection of the major oncogenic HPV types through the detecting HPV antigens be considered technically acceptable?

Answer 1: An antigen-based application would likely be within the scope of the topic. An antigen test that provides types would likely be within the scope of the topic.

Question 2: In the Phase I activities and deliverables, for the statement, “Should establish initial clinical performance for the device using clinician-collected samples before moving to a larger prospective validation of the device using self-collected specimens”, do you expect to see the plan for further clinical study or clinical data in the phase 1 proposal using the prototype the offeror is planning to build?

Answer 2: This really depends on whether the application is coming in as a fast track application or not. If not, we don’t need to see Phase II plans.

Question 3: Should we validate the prototype with self-collected cervicovaginal specimens in addition to the target plasma?

Answer 3: This proposal is explicitly focused on HPV diagnostics for cervical cancer control and the tests should therefore be based on cervicovaginal specimens.

Question 4: Should we include one of the current commercially available kits, which is limited to self-collection, even if it is not genotyping device or should we include a commercially available HPV PCR test to confirm.

Answer 4: Comparison to state-of-the-art is essential to evaluate quality and should be based on PCR or equivalent test with typing.

Question 5: What’s the target price or range for “affordable lower cost for low-resource settings”?

Answer 5: There is no fixed “target price.” It is incumbent upon the applicant to establish a justification for the affordability of their product within intended use settings, especially those where validation studies are proposed, thus ensuring that the results of the research can be equitably translated to commercial products in those settings.

National Cancer Institute (NCI), Topic 452: Translation of Novel Cancer-Specific Imaging Agents and Techniques to Mediate Successful Image-Guided Cancer Interventions

Question 1: Would the development of a new biopsy device (to extract suspicious tissues based on their molecular signature) used along with a dynamically modifiable collimator (gamma-ray "optic") for Molecular Breast Imaging (MBI) fit into this topic description?

Answer 1: This proposed project may have the potential for a fit if the team could present evidence that their technique/strategy is capable of spatially resolving tumors down to 1 cubic millimeter.

Question 2: Regarding the section “Phase I activities and deliverables” and the following item: Submit and acquire single IRB approval for recruitment of patients undergoing cancer surgery with the selected molecular probe labeling for the selected cancer to validate the molecular probe’s capabilities to identify additional cancers that were not detected by normal white light or palpation.

Is IRB and studies involving human subjects a requirement for Phase I proposals?

Answer 2: Yes, the submission of a single IRB for recruitment of patients undergoing cancer surgery with the selected molecular probe, during third or fourth quarter of the Phase I contract, is a requirement. It is reasonably understood that the single IRB approval process may take several months there after the submission.

National Cancer Institute (NCI), Topic 453: Digital Tools to Integrate Cancer Prevention Within Primary Care

Question 1: The topic asks for 25 PCPs and patients in Phase I and 100 PCPs and patients in Phase II. Does this mean 25 PCPs and 25 patients in Phase I and 100 PCPs and 100 patients in Phase II?

According to the Webinar, this is combined. Correct?

Answer 1: The requested sample sizes are combined (so 25 combined PCPs and patients for Phase I and 100 combined PCPs and patients for Phase II).

Question 2: Do we have to include letters from the 25 primary care facilities, or can we provide strategies on how we will recruit those facilities?

Answer 2: You don’t need to include letters from the 25 care facilities. You do want to provide strategies on how you will recruit those facilities. If possible, you could provide a few names of the facilities as examples.

Question 3: Would the development of a next-gen platform Machine-learning Augmented Referral System (MARS) to help more domestic cancer patients align with the goals of this topic?

Answer 3: The proposed project does not align with the goal. While the tool has AI/ML components, it does not appear to fall into the category of a medical device development tool since it is not intended to analyze AI/ML for medical devices.

NATIONAL INSTITUTE ON AGING (NIA)

National Institute on Aging (NIA), Topic 008: Improving Microphysiological Systems for AD/ADRD Therapy Development

Question 1: The solicitation for NIH/NIA 008 mentions in several places that drugs with clinical efficacy against AD/ADRD should be tested in the prototype microphysiological system. For example:

• Test multiple agents with known clinical profiles in the developed prototype (Phase I activity/deliverable)

• Test at least one AD/ADRD therapeutic agent with a known clinical profile using the developed prototype (Phase II)

• Compare dose-response relationships of known AD/ADRD therapeutic agents (Phase

II)

Please give examples of therapeutic compounds for AD/ADRD that would fulfill these criteria.

Answer 1: Examples include therapeutic agents that have a known clinical profile in humans (i.e. drugs on the market or clinical trials).

Question 2: Will the NIH/NIA make aducanumab, and related monoclonal antibodies in clinical trials for AD, available to researchers for this project?

Answer 2: Unfortunately, no.

Question 3: Will the iPSC lines in the Chan Zuckerberg Initiative, The Jackson Laboratory, which are for AD/ADRD and other neurodegenerative diseases be made available to small businesses for this project?

Answer 3: This initiative is currently working on proprietary negotiations, which will hopefully be resolved soon.

In the meantime, other iPSC resources include:

• Rutgers/Coriell NINDS Human Genetics DNA and Cell Line Repository

• European Bank for induced pluripotent Stem Cells (EBiSC)

• National Centralized Repository for Alzheimer's Disease and Related Dementias (NCRAD)

• NYSCF Stem Cell Repository

• Cedars-Sinai Regenerative Medicine Institute

National Institute on Aging (NIA), Topic 009: AI/ML Tool for Visualizing Behavioral and Social Science

Research

Question 1: I wondered if I could get a bit more insight from you into the context for the below announcement, as we work in the area of Alzheimer's disease and large data analysis. I was in particular curious about the statement of the intended market - would it be just to social and behavioral scientists, or is it intended to be more broadly utilized, but process data from social and behavioral science in a manner related to Alzheimer's (or both)?

Answer 1: The envisioned tool can be much more broadly utilized, but the work should start with Behavioral/Social Sciences in particular for several reasons, amongst which is the need to encourage folks working in this discipline to ‘get up to speed’ as rapidly and efficiently as possible given the magnitude of the public health crisis and the lack of any biological/pharmacologic interventions to slow or prevent this disease. As well, there is a great need for behavioral/social/economic/etc solutions to help support caregivers of persons living with dementia. So the focus on behavioral and social sciences is warranted as a starting point for the development of this tool. It surely can be (and should be) broadened to incorporate other scientific disciplines (and that may be facilitated by already-existing taxonomies in those disciplines, which is lacking in behavioral/social sciences currently).

Question 2: What are the current tools used by behavioral and social scientists (Alzheimer’s researchers) to understand the AD portfolio?

Answer: See chart below.

Question 3: What are the limitations of the current solutions?

Answer 3: Current solutions do not actively extract, aggregate, and visually map variables and causal relationships like the proposed system.

NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID)

National Institute of Allergy and Infectious Diseases (NIAID), Topic 114: Point-of-Care HIV Viral Load, Drug Resistance, and Adherence Assays NOTE: The following questions are related to Focus Area #3: Pharmacological Adherence Monitoring

Question 1: For clinic settings, does the diagnostic device still need to be hand-held or disposable?

Answer 1: It is optional for clinical settings.

Question 2: Hair and DBS samples will require specialized processing methods. Do these samples need to be supported by a point-of-care diagnostic?

Answer 2: Yes. All assays must be run on a POC device regardless of the sampling method.

Question 3: Will this call support the development of new methods/equipment to enable hair or DBS processing at the point-of-care?

Answer 3: Yes. Processing of hair and DBS is part of the goal, but the Offerors also have to demonstrate that they can run the extracts in the POC assay and obtain results. Please review the “Methods of Evaluation” Section on pages 34-36 of the PHS2023-1 solicitation.

Question 4: Is it necessary to demonstrate feasibility of all mentioned samples (blood, DBS, urine, saliva, and hair) during the Phase I project period?

Answer 4: No. You can specify a particular collection method or methods for phase I.

Question 5: Is it desirable to run multiple tests on the same platform, such as multiple immunoassays for different ARTs or HIV viral load?

Answer 5: Yes, it would be desirable, but not required. Please review the “Methods of Evaluation” Section on pages 34-36 of the PHS2023-1 solicitation.

National Institute of Allergy and Infectious Diseases (NIAID), Topic 115: Development of Diagnostics to

Differentiate HIV Infection from Vaccine-Induced Seropositivity Question 1: We are considering applying to both topics NIAID-114 and NIAID-115 with two different projects. Will these two topics be evaluated by the same panel of reviewers?

Answer 1: The Peer Reviews for each topic will be separate evaluations meetings. The Government reserves the right to use some of the same reviewers on each panel if their expertise will benefit each topic review.

Question 2: The target market for this test is HIV-negative individuals who have received HIV vaccines. Are these individuals expected to be on PrEP?

Answer 2: The target populations will be people on PrEP/HAART who did or did not receive an HIV vaccine, HIV-uninfected people not on PrEP/HAART who did or did not receive an HIV vaccine, and people living with HIV +/- HAART. It is possible that some HIV-vaccinated individuals will likely have markers (antibodies) that can be identified in the current HIV screening tests as positive, but, in reality, those individuals will have VISP.

Question 3: Can you clarify what is meant re: “false-negative NAT results due to undetectable viral loads”?

Is p24 antigen expected to be detectable in such samples?

Answer 3: Viral loads can be below the level of detection for some assays depending on the level of control obtained with anti-retroviral drugs. Depending on the phase of the infection, “when HIV infection is present,” p24 antigen can or cannot be detectable.

Question 4: Could a low-cost viral load NAT alone be responsive if capable of detecting viral load < 200-

500 copies/mL?

Answer 4: It is unlikely that a test based only on detection of NAT <200-500 copies/mL will be able to satisfactory address false-positive HIV tests due to VISP.

Question 5: Would a multiplex test panel consisting of viral load (cut-off ~200-500 copies/mL) with p24 antigen and/or HIV 1/2 antibody immunoassay be responsive?

Answer 5: [The Government] expects responsive proposals will be based on multiplex assays, however, the rational for what antigens, antibodies and/or NAT to be included will need to be developed and evaluated during the peer-review session.

Question 6: For blood bank testing, would the test(s) be used for individual units or pooled units? How does the LoD for a single patient blood sample relate to an LoD needed for blood bank screening?

Answer 6: [The Government] does not expect the assays developed under this opportunity to have a blood bank indication.

National Institute of Allergy and Infectious Diseases (NIAID), Topic 118: Reagents for Immunologic Analysis of

Non-mammalian and Underrepresented Mammalian Models Question 1: Is it permissible to propose an under-represented mammalian model other than those listed in the Topic?

Answer 1: No. As stated in the solicitation, non-mammalian models are limited to arthropods, amphibians, fish

(e.g., jawless fish, sharks, zebrafish), nematodes, birds and marine echinoids and under-represented mammalian models are limited to guinea pig, ferret, bat, mink, hamster, cotton rat, pig (including minipigs), rabbit and marmoset.

National Institute of Allergy and Infectious Diseases (NIAID), Topic 120: Modular Sample Preparation for In-

Field Viral Discovery Question 1: For this project goal, is NIAID looking for a technology that can accept multiple specimen types or would a technology that can only process blood be competitive?

Answer 1: The technology would be competitive for a single sample type if it otherwise improves in-the field processing in a significant way. (e.g. higher throughput; higher quality of analyte; etc).

Question 2: What do you mean by modularity?

Answer 2: Modularity refers to the sample type (blood vs urine vs saliva etc)

Question 3: Does "modularity" refer to working with a wide variety of pathogens?

Answer 3: Modularity refers to the different types of samples that may need processing such as blood vs urine vs feces vs etc.

Question 4: What do you envision with a "high throughput" device, since field use devices have a limited level of "high- throughput" that can be achieved because there will be little to no electricity at collection sites.

Answer 4: The goal is to develop technology that improves the throughput of sample processing for in the field studies.

Question 5: Do you have a minimum number for high-throughput?

Answer 5: The throughput degree should be an improvement to currently available commercial systems.

National Institute of Allergy and Infectious Diseases (NIAID), Topic 123: Data Science Tools for Infectious and

Immune-mediated Disease Research Question 1: Is a federal laboratory eligible to be a sub-contractor on our proposal?

Answer 1: To the extent Federal laboratory services are proposed, documentation must be included that demonstrates the laboratory’s services are routinely available to all offerors free of charge/unpaid.

Please also refer to solicitation section 4.2 ‘Offeror Eligibility and Performance Requirements’ for information regarding percentage of work requirements applicable to the awardee.

National Heart, Lung, and Blood Institute (NHLBI)

National Heart, Lung, and Blood Institute (NHLBI), Topic 113: Clinical Instrument for Para-Hydrogen (pH2)

Based Signal Amplification by Reversible Exchange (SABRE) for Hyperpolarizing 13C-Pyruvate and Other Probes for MRI Imaging

Question 1: Can we submit a proposal for an alternative approach that addresses the end objectives? This would require changes to some Phase I deliverables but would meet the same output of the final deliverable.

Answer 1: NHLBI intends to make an award for Topic 113 for a proposal that successfully addresses the objectives and approach as outlined in the solicitation

National Heart, Lung, and Blood Institute (NHLBI), Topic 114: Device to Permit Continuous Self-Monitoring of

Blood Oxygen Saturation During Activities of Daily Living for Individuals at Risk for Desaturation During Physical Exertion

Question 1: There is a note in the solicitation that the contracting DIR lab will perform clinical trials. Does that only include the Phase II studies, or is it expected that the contracting DIR lab will test the device in Phase I (instead of the awardee).

Answer 1: NHLBI plans to test the device prior to the end of Phase I to confirm that the appropriate objectives were achieved (as outlined in the resultant contract). Phase II would include clinical trials that enroll different patient populations.

Centers for Disease Control and Prevention (CDC)

CDC/National Center for Emerging Zoonotic and Infectious Diseases (NCEZID), Topic 030: Developing an Over-the-Counter Diagnostic Test for Valley Fever

Question 1: Will CDC help to perform the test after it was developed? Or can you provide reference to collaborators for testing? The pathogen needs a BSL3 lab to handle.

Answer 1: Successful offerors will resource appropriate facilities, equipment, and expertise to develop a simple and fast diagnostic test for Valley Fever. This includes any materials used for the development and testing of the diagnostic. The offeror should not expect assistance from CDC for the development or testing of materials or products

CDC/National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Topic 054: School Illness- Related Absenteeism and Learning Modality Surveillance

Question 1: Given, the number of people working from home (due to COVID), how do we address the issue of work potentially being done outside of the US? We have a consultant who would potentially be doing the work from Canada. Do we address this potential issue if we are awarded a contract, or should we address this potential issue as part of our proposal? The work to be done is primarily review of data - all the data creation and cataloging will be done in the US.

Answer 1: Per section 4.2 (Offeror Eligibility and Performance Requirements) of the SBIR PHS 2023-1 Contract Solicitation:

To receive SBIR funds, each awardee of a SBIR Phase I or Phase II award must qualify as a small business concern (SBC) at the time of award and at any other time set forth in SBA's regulations at 13

CFR 121.701-121.705.

Further, for both Phase I and Phase II, all research or research and development work must be performed by the SBC and its subcontractors in the United States.

Based on rare and unique circumstances, deviations from these performance requirements may be considered on a case-by-case basis. Requests for such potential deviations should be included as part of the proposal.

End of Amendment 1