Amendment 1.pdf

Amendment #1 to BAA-NIAID-75N93023R00002

Amendment to Solicitation No: BAA-NIAID-75N93023R00002

Amendment No.: 1

Issue Date: July 6, 2023

Effective Date: July 6, 2023

Proposal Due Date: 3:00 P.M. Eastern Time (ET) on 9/20/2023

Issued By: Deborah Blyveis Contracting Officer

NIH/NIAID/DEA

Office of Acquisitions 5601 Fishers Lane Room 3B68 MSC 9821 Rockville, MD 20852

Point of Contact: Deborah Blyveis, Contracting Officer blyveisd@niaid.nih.gov

Name and Address of Offeror: To all Potential Offerors

Offerors MUST acknowledge receipt of the Amendment(s) by Amendment number(s) and date(s). Failure to receive your acknowledgment of this amendment may result in the rejection of your proposal.

The deadline for submitting questions is 3:00 P.M. Eastern Time (ET) on 8/18/2023.

mailto:blyveisd@niaid.nih.gov

SECTION 1- QUESTIONS AND RESPONSES

This section of the amendment provides questions submitted by potential offerors and the responses provided by NIAID. The responses are offered for information only and do not modify or become part of this solicitation. This Amendment will be updated as needed to add further questions and their related responses. All potential offerors are advised to refer back to all previous amendments for additional questions and clarification.

1. Please instruct whether non-protein B-cell epitope discovery for emerging infectious agents is considered responsive to this contract solicitation.

Answer: Non-protein B-cell epitope discovery for emerging infectious agents is responsive. Please note that human epitope discovery and validation are required components.

2. Are mpox, yellow fever, H5N1 (human epitope), Paramyxovirus, and cross-reactive anti-NA influenza epitopes of interest in this proposal?

Answer: Mpox, yellow fever, H5N1 (human epitope), Paramyxovirus, and cross-reactive anti- NA influenza epitopes fit within the discovery of novel B cell epitopes associated with human responses to pathogens/vaccines for infectious diseases as outlined in the BAA. As a reminder, HIV is excluded.

3. How many contracts does NIAID expect to award for this call?

Answer: NIAID expects to award multiple contracts from this solicitation.

4. Is it expected that epitopes targeted by human and mouse B cells are both of NIAID’s interest for this call, or one is preferred over another?

Answer: Human B cell epitope discovery and validation in human populations are required elements.

5. Is BAA-NIAID-75N93023R00002 for small business?

Answer: It is a full and open competition. Small and large businesses may submit proposals.

6. I am inquiring about eligibility of PI/institutions from non-US countries.

Answer: Non-US institutions may submit proposals.

7. Can the PI make someone a delegate and submit the application on his/her behalf, or does this application have to be fully submitted by the PI.

Answer: Someone else can upload the proposal into our eCPS system. The BAA contract proposal must be submitted according to the instructions in the BAA posted on SAM.gov. A contract will be awarded which is different from a grant.

8. FAR Clause 52.223-3 Hazardous Material Identification and Material Safety Data is referenced in the BAA. When do we need to provide this information? With our application? If so, should this be contained in the Technical or Business Proposal?

Answer: Please provide this information in both the Technical and Business Proposals.

9. What is the estimated range of funding allowable for each award under this solicitation?

Answer: Attachment 3, Broad Agency Announcement Description, states: “NIAID estimates that the average annual total cost (direct and indirect costs combined) is $1.5M per award.” The term of the contract will be one (1) Base Year and four (4) option periods, for a total of 5 years.

10. Does the "high-throughput" requirement concern both discovery and validation, or discovery alone may be sufficient to satisfy the program? If it is for both components, what does the program consider "high-throughput" for the experimental validation (dozens, hundreds, or thousands of epitopes)?

Answer: high-throughput applies to both discovery and validation. It would be expected that discovery would be higher throughput than validation based on the nature of each. Generally high throughput means hundreds or thousands, based on either validation or discovery steps.

With respect to this question, dozens could be interpreted as approaching hundreds over the contract period, particularly with respect to validation, less likely so for discovery.

SECTION 2- SECTION J

Please see a revised Section J on the next page updating some of the attachment links.

BAA Number : BAA-NIAID-75N93023R00002

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PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

The following documents are incorporated into this RFP:

SOLICITATION ATTACHMENTS

Attachment No. Title Location

Attachment 1: Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website

See the Attachments Section at the end of this BAA.

Attachment 2: Proposal Intent Response Sheet See the Attachments Section at the end of this BAA.

Attachment 3: Broad Agency Announcement Description See the Attachments Section at the end of this BAA.

Attachment 4: Background and Introduction See the Attachments Section at the end of this BAA.

Attachment 5: Research and Technical Objectives See the Attachments Section at the end of this BAA.

Attachment 6: Reporting Requirements and Deliverables See the Attachments Section and the end of this BAA.

Attachment 7: Additional Technical Proposal Instructions See the Attachments Section at the end of this BAA.

Attachment 8: Additional Business Proposal Instructions See the Attachments Section at the end of this BAA.

Attachment 9: Advance Understandings See the Attachments Section at the end of this BAA.

Attachment 10: eRDS Electronic Report Deliverables Submission

See the Attachments Section at the end of this BAA.

Attachment 11: Section K - Representations, Certifications, and Other Statements of Offerors

See Section K and the Attachment at the end of this BAA.

TECHNICAL PROPOSAL ATTACHMENTS

Attachment No. Title Location

Attachment 12: Technical Proposal Cost Summary https://oamp.od.nih.gov/sites/default/files/ DGS/contracting-forms/Tech-Prop-Cost- Summ.pdf

Attachment 13: Summary of Related Activities https://oamp.od.nih.gov/sites/default/files/ DGS/contracting-forms/summary-related-activities.pdf

Attachment 14: Protection of Human Subject Assurance Identification/IRB Certification/Declaration of Exemption, OMB Form No. 0990-0263 (Formerly Optional Form 310) https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j

Attachment 15: Contract Proposal Vertebrate Animal Section (VAS) Worksheet https://grants.nih.gov/grants/olaw/ vascontracts.pdf https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j

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Attachment No. Title Location

Attachment 16: Voluntary Product Accessibility Template

(VPAT)

https://www.section508.gov/sell/vpat/

BUSINESS PROPOSAL ATTACHMENTS

Attachment No. Title Location

Attachment 17: Proposal Summary and Data Record, NIH-2043 https://oamp.od.nih.gov/sites/default/files/ DGS/contracting-forms/NIH2043.pdf.

Attachment 18: Small Business Subcontracting Plan https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j

Attachment 19: Breakdown of Proposed Estimated Costs (plus fee) w/Excel Spreadsheet https://oamp.od.nih.gov/content/breakdown-proposed-estimated-cost-plus-fee-and-labor-hours and https://oamp.od.nih.gov/ sites/default/files/DFASDocs/ buscntrctprpslsprdsht08-2014_508.xlsx

Attachment 20: Offeror's Points of Contact https://oamp.od.nih.gov/sites/default/files/ DGS/contracting-forms/point-of-contact.pdf

Attachment 21: Certificate of Current Cost or Pricing Data https://oamp.od.nih.gov/sites/default/files/ DGS/contracting-forms/cert-current-cost.pdf

Attachment 22: Disclosure of Lobbying Activities, OMB Form SF-LLL https://www.gsa.gov/forms-library/ disclosure-lobbying-activities

INFORMATIONAL ATTACHMENTS

Attachment No. Title Location

Attachment 23: Invoice/Financing Request and Contract Financial Reporting Instructions--Cost Reimbursement, NIH(RC)-4 https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j

Attachment 24: Privacy Act System of Records https://www.hhs.gov/foia/privacy/sorns/nih-sorns.html

Attachment 25: Safety and Health, HHSAR Clause 352.223-70 https://oamp.od.nih.gov/sites/ default/files/DGS/FORMS/ hhsar_352.223-70_safety_and_health_508.pdf

Attachment 26: Research Patient Care Costs, NIH(RC)-11 https://oamp.od.nih.gov/sites/default/files/ DGS/contracting-forms/rc11.pdf

Attachment 27: PHS Human Subjects and Clinical Trials Information Form https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j

Attachment 28: Inclusion Enrollment Report included in PHS Human Subjects and Clinical Trials Information Form https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j

Attachment 29: Public Health Surveillance Exclusion Request https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j

Attachment 30: Electronic Invoicing Instructions for NIH Contractors/Vendors https://oamp.od.nih.gov/sites/default/files/ dgs/Communication%20to%20Vendors %20on%20Deadline%20to%20Stop %20Accepting%20Mailed%20Invoice_ %20Final%2011-4-20-508.pdf https://www.section508.gov/sell/vpat/ https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j https://oamp.od.nih.gov/content/breakdown-proposed-estimated-cost-plus-fee-and-labor-hours https://oamp.od.nih.gov/content/breakdown-proposed-estimated-cost-plus-fee-and-labor-hours https://oamp.od.nih.gov/content/breakdown-proposed-estimated-cost-plus-fee-and-labor-hours https://oamp.od.nih.gov/sites/default/files/DFASDocs/buscntrctprpslsprdsht08-2014_508.xlsx https://oamp.od.nih.gov/sites/default/files/DFASDocs/buscntrctprpslsprdsht08-2014_508.xlsx https://oamp.od.nih.gov/sites/default/files/DFASDocs/buscntrctprpslsprdsht08-2014_508.xlsx https://www.gsa.gov/forms-library/disclosure-lobbying-activities https://www.gsa.gov/forms-library/disclosure-lobbying-activities https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j https://www.hhs.gov/foia/privacy/sorns/nih-sorns.html https://www.hhs.gov/foia/privacy/sorns/nih-sorns.html https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j

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Attachment No. Title Location https://oamp.od.nih.gov/sites/default/files/ DGS/Electronic Invoicing Step-by-Step Instructions 7-22.pdf