75N93022R00023_T-Cell_ Amendment 2.pdf

Amendment #2 to BAA-NIAID-DAIT-75N93022R00023

LARGE-SCALE T CELL IMMUNE EPITOPE DISCOVERY AND MECHANISMS OF T CELL

PROTECTION

Amendment to Solicitation No.: BAA-NIAID-DAIT-75N93022R00023

Amendment No.: 2

Issue Date: July 13, 2023

Effective Date:

Proposal Due Date:

July 13, 2023

July 19, 2023, until 3:00 pm EST (UNCHANGED)

Issued By: Anuj Patel Contracting Officer

NIH/NIAID

Office of Acquisitions 5601 Fishers Lane Room 3B66 MSC 9821 Rockville, MD 20852

Point of Contact: Anuj Patel, Contracting Officer Anuj.patel@nih.gov

Name and Address of Offeror: To All Potential Offerors

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

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

The purpose of Amendment 2 is to respond to questions from potential offerors and to update Section J, Attachments 26.

SECTION 1- QUESTIONS AND RESPONSES

This section of the amendment provides questions submitted by potential applicants/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 to the original solicitation document for additional clarification.

Question 1: Could you please clarify the CV page limit. There are various lengths in the BAA. We believe the limit is 5 pages for the PI(s) and 3 pages for everyone else but would appreciate confirmation.

Page 110 of the pdf indicates 3 pages Page 130 of the pdf indicates 2-3 pages Page 130 of the pdf a couple lines down says the PI's CV can be 5 pages Page 131 of the pdf says 3 pages for key scientific and technical personnel

Response to Question 1: The Principal Investigator may have up to five (5) pages for their CV/Biosketch. Other scientific and technical personnel may have up to three (3) pages for the CV/Biosketch.

Applicants should follow the instructions on pages 130 for the Principal Investigator and 131 for Other Key Scientific and Technical Personnel.

Question 2: The request for proposal emphasis the validation of alloepitopes presented by recipient HLA class II to recipient CD4+ T cells (attachment 4, page 5 of BAA) as well as CD4+ T cell epitopes derived from donor alloantigens presented by recipient class II (attachment 5, page 7 of BAA). We consider using samples from hematopoietic stem cell transplants as our source materials to examine alloreactivity in GVHD. In this context, the emphasis will be on recognition of “alloantigens” by donor T cells. The alloantigens in this case will also be self antigens of the recipient. Will a proposal with a focus of alloreactivity under the hematopoietic stem cell transplant setting as mentioned above meet the requirements of this announcement?

Response to Question 2: A proposal examining alloreactivity in transplantation would be appropriate for this BAA.

Question 3: Can you provide the submission instructions for the electronic submission?

Response to Question 3: Please use the following link to submit proposals via eCPS.

https://ecps.nih.gov/HowToSubmit

Question 4: Is there a checklist available for how to order the attachments and proposal details within each of the uploads for eCPS for this RFA?

Response to Question 4: The proposal submission instructions can be found on Page 57, SECTION L

- INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS, item 2. Instructions to offerors.

Question 5: If a PI had contracts submitted under the previous submission website, would they still be able to access those proposals under the new eCPS??

Response to Question 5: They will only have access to the new proposals under the new eCPS.

Question 6: Can you please provide a revised link for Attachment 13 – Summary of Related Activities?

Response to Question 6: Please use the updated link for Attachment 13 – Summary of related activities. http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/summary-related-activities.pdf

Question 7: If the submitting PI is in the NIH Enterprise Directory, do we need to submit the CONTRACTOR NON-DISCLOSURE AGREEMENT (NDA)? If so, does it go in the Business Proposal?

Response to Question 7: CONTRACTOR NON-DISCLOSURE AGREEMENT (NDA) must be submitted as a part of the Business Proposal.

http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/summary-related-activities.pdf http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/summary-related-activities.pdf

Question 8: The solicitation states, “award(s) will be made on/about July 01, 2024.” Can we use September 2024 as the start date to avoid overlap with a current contract?

Response to Question 8: The current estimated date of award is July 01, 2024, the award date can be negotiated with competitive offerors.

Question 9: Human Subjects (pg. 48 Attachment 27 and pg. 66 of the solicitation) If multiple sites are proposing human subjects work, do we submit a separate Attachment 27 for each site in eCPS? Does this count toward the 150-page limit of the Technical Proposal? What information about human subjects should be included in the Technical Proposal vs. Attachment 27?

Response to Question 9: The offeror should provide a concise human subject section within the technical proposal sufficient for the reviewers to understand the populations considered in the protocol, the number of individuals who will be enrolled, and the statistical rigor with which the numbers of subjects to be enrolled was decided. Please refer to solicitation document on page 70 for more instructions about research involving human subjects that occurs at the collaborating site(s).

The Human Subjects form is not included in the 150-page count in the Technical Proposal. Each site would require a separate PHS Human Subjects and Clinical Trials Information form.

Documentation for the human subject section shall be provided in the Business Proposal as well.

Please refer to Section 4 - TABLE OF CONTENTS FOR DOCUMENTATION REQUIRED UNDER SECTION L OF THE BAA, page 135 of the solicitation document.

Question 10: Past Performance Information vs. Qualifications of the Offeror (pg. 63 and 98 of the solicitation, respectively) For the “Past Performance Information” (pg. 63), is this section only for scientifically similar contracts? Or all contracts >$750,000 within the past year that our institute has managed? For the Qualifications of the Offeror (pg. 98), how is this different than the “Past Performance Information”? Is this section for previous scientific accomplishments related to the current proposal with data/figures?

Response to Question 10: Past Performance Information relates directly to the Offeror (PI) proposing the offer and their experience with contracts >$750,000.

General experience is defined as general background, experience, and qualifications of the offeror

(PI).

Organizational Experience Related to the RFP (This section deals with the organization’s experience related to the RFP)

Organizational experience is defined as the accomplishment of work, either past or on-going, which is comparable or related to the effort required by this RFP. This includes overall offeror or corporate experience, but not the experience and/or past performance of individuals who are proposed as personnel involved with the Statement of Work in this RFP.

Question 11: Do commitment letters go in the business proposal, but a description of additional personnel and services they will provide go in the Technical Proposal SOW?

Response to Question 11: Commitment letters must be included in the business proposal. The descriptions of additional personnel and services must be included in the Technical Proposal Statement of Work. Please refer to Item 12 – Subcontracts on page 99 of the solicitation document.

Question 12: How strict will the NIH be on hyperlinks? For example, some of our letters of support contain links on the letterhead, biosketches contain MyNCBI links, sometimes it’s important to reference a website, etc.

Response to Question 12: Proposals shall not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information. Please refer to Section II - FORMATTING AND PAGE LIMITATIONS Formatting for proposals, on page 110 of the solicitation document.

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-174.html

Applicants should follow the guidance in this NIH notice concerning allowable and non-allowable hyperlinks.

Question 13: Are student expenses (tuition, student fees, etc.) allowable costs?

Response to Question 13: FAR 31.205-44 Training and education costs.

Costs of training and education that are related to the field in which the employee is working or may reasonably be expected to work are allowable, except as follows:

(a) Overtime compensation for training and education is unallowable.

(b) The cost of salaries for attending undergraduate level classes or part-time graduate level classes during working hours is unallowable, except when unusual circumstances do not permit attendance at such classes outside of regular working hours.

(c) Costs of tuition, fees, training materials and textbooks, subsistence, salary, and any other payments in connection with full-time graduate level education are unallowable for any portion of the program that exceeds two school years or the length of the degree program, whichever is less.

(d) Grants to educational or training institutions, including the donation of facilities or other properties, scholarships, and fellowships are considered contributions and are unallowable.

(e) Training or education costs for other than bona fide employees are unallowable, except that the costs incurred for educating employee dependents (primary and secondary level studies) when the employee is working in a foreign country where suitable public education is not available may be included in overseas differential pay.

(f) Contractor contributions to college savings plans for employee dependents are unallowable.

Parent topic: 31.205 Selected costs.

Question 14: For the technical proposal, are we allowed to exceed suggested page limits on certain sections as long as the total does not exceed the 150-page limit?

Response to Question 14: That is correct. Please refer to Section II - FORMATTING AND PAGE LIMITATIONS Formatting for proposals, Item B. Page limitations, on page 110 of the solicitation document.

Question 15: Is the “Other Considerations” section of the Technical Proposal where we should include the Vertebrate Animals, Authentication of Key/Biological Resources, Resource Sharing Plan, Data Management and Sharing Plan, and Section 508 accessibility standards?

Response to Question 15: That is correct.

Question 16: Regarding the DMSP, the solicitation offers conflicting information on where the DMSP should be included in the proposal. The DMSP is repeatedly referred to as an aspect of the technical proposal. However, the https://www.acquisition.gov/far/31.205 checklist below, from the solicitation, states that it must be included in the business proposal, while listing it as a section of the technical proposal. Please clarify what is necessary, in terms of the DMSP, in the technical proposal and in the business proposal.

Response to Question 16: Please provide a statement in Section L that offeror plans to conform with the NIH Data Management and Sharing Policy. The Data Management and Sharing Plan should be included in the Business Proposal.

Question 17: Are we allowed to submit a 4th additional file to eCPS entitled something like xxxxxxx_humansubject.pdf with the required PHS forms in attachments 26 and 27, or are these materials included in the 150 page tech proposal?

Response to Question 17: The offeror should provide a concise human subject section within the technical proposal sufficient for the reviewers to understand the populations considered in the protocol, the number of individuals who will be enrolled, and the statistical rigor with which the numbers of subjects to be enrolled was decided.

The Human Subjects form is not included in the 150-page count in the Technical Proposal. Each site would require a separate PHS Human Subjects and Clinical Trials Information form.

Documentation for the human subject section shall be provided in the Business Proposal as well.

Please refer to Section 4 - TABLE OF CONTENTS FOR DOCUMENTATION REQUIRED UNDER SECTION L OF THE BAA, page 135 of the solicitation document.

END OF AMENDMENT NO. 2, BAA-NIAID-DAIT-75N93022R00023

* Always required field

Study Record: PHS Human Subjects and Clinical Trials Information OMB Number: 0925-0001

Expiration Date: 01/31/2026

Section 1 - Basic Information

1.1. * Study Title (each study title must be unique)

1.2. * Is this Study Exempt from Federal Regulations?

1.3. Exemption Number

1 2 3 4 5 6 7 8

1.4. * Clinical Trial Questionnaire

If the answers to all four questions below are yes, this study meets the definition of a Clinical Trial.

1.4.a. Does the study involve human participants? Yes No 1.4.b. Are the participants prospectively assigned to an intervention? Yes No

1.4.c. Is the study designed to evaluate the effect of the intervention on the participants? Yes No 1.4.d. Is the effect that will be evaluated a health-related biomedical or behavioral outcome? Yes No

1.5. Provide the ClinicalTrials.gov Identifier (e.g., NCT87654321) for this trial, if applicable

Section 2 - Study Population Characteristics

2.1. Conditions or Focus of Study

2.2. Eligibility Criteria

2.3. Age Limits Minimum Age Maximum Age

2.3.a. Inclusion of Individuals Across the Lifespan

2.4. Inclusion of Women and Minorities

2.5. Recruitment and Retention Plan

2.6. Recruitment Status

2.7. Study Timeline

2.8. Enrollment of First Participant

2.9. Inclusion Enrollment Report(s)

Yes No

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Add Inclusion Enrollment Report

Inclusion Enrollment Report

OMB Number: 0925-0770 Expiration Date: 09/30/2024

1. * Inclusion Enrollment Report Title

2. * Using an Existing Dataset or Resource

3. * Enrollment Location Type

4. Enrollment Country(ies)

5. Enrollment Location(s)

6. Comments

Remove Inclusion Enrollment Report

Yes No

Domestic Foreign x Add New Country

Planned

Racial Categories

Ethnic Categories Not Hispanic or Latino Hispanic or Latino Total

Female Male Female Male

American Indian/ Alaska Native

Asian

Native Hawaiian or Other Pacific Islander

Black or African American

White

More than One Race

Total

Cumulative (Actual)

Racial Categories

Ethnic Categories Not Hispanic or Latino Hispanic or Latino Unknown/Not Reported Ethnicity Total

Female

Male

Unknown/ Not

Reported

American Indian/ Alaska Native

Asian

Native Hawaiian or Other Pacific Islander

Black or African American

White

More than One Race

Unknown or Not

Total

Report 1 of 1

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Section 3 - Protection and Monitoring Plans

3.1. Protection of Human Subjects

3.2. Is this a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site?

Yes No N/A

4.1. Study Design

4.1.a. Detailed Description

4.1.b. Primary Purpose

4.1.c. Interventions x Intervention Type

Name

Description

4.1.d. Study Phase

Is this an NIH-defined Phase III clinical trial? Yes No

4.1.e. Intervention Model

4.1.f. Masking

Yes

Participant

No

Care Provider Investigator Outcomes Assessor

4.1.g. Allocation

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3.3. Data and Safety Monitoring Plan Add Attachment Delete Attachment View Attachment

3.4. Will a Data and Safety Monitoring Board be appointed for this study?

Yes No

3.5. Overall Structure of the Study Team Add Attachment Delete Attachment View Attachment

Section 4 - Protocol Synopsis

Add New Intervention

4.2. Outcome Measures

x Name

Type

Time Frame

Brief Description

4.3. Statistical Design and Power

4.4. Subject Participation Duration

4.5. Will the study use an FDA-regulated intervention? Yes No

4.5.a. If yes, describe the availability of Investigational Product (IP) and Investigational New Drug (IND)/Investigational Device Exemption (IDE) status

4.6. Is this an applicable clinical trial under FDAAA? Yes No

4.7. Dissemination Plan

Section 5 - Other Clinical Trial-related Attachments

5.1. Other Clinical Trial-related Attachments

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