Responses to Questions Amendment 2.pdf

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Early Phase Clinical Trial Units (EPCTU)
Solicitation number
RFP-NIAID-NIH-AI-75N93020R00023
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This document contains responses to questions from offerors on an amendment to a request for proposal from the National Institutes of Health National Institute of Allergy and Infectious Diseases. The RFP seeks proposals for Early Phase Clinical Trial Units to conduct clinical research on infectious diseases and immunology. Offerors must submit separate technical proposals for each of five task areas, with a 75-page limit for Task Area A and 150-page limits for Task Areas B through E. Offerors may propose on Task Area A alone or in combination with some or all of Task Areas B through E. The technical proposal for each task area or combination of task areas must be uploaded as a separate document due to file size limitations. The amendment clarifies page limits and proposal formatting requirements.

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Text version

REQUEST FOR PROPOSAL

(RFP) NUMBER: NIAID-NIH-AI-75N93020R00023

AMENDMENT NUMBER: 2

TECHNICAL VOLUME QUESTIONS

Solicitation Reference

(page and section)

Solicitation Reference Text Question to Government Comments

General Attachment 3 SOW Do the offerors have to have an IND in place?

The offerors do not need to have an IND in place, mainly because NIAID plans to hold the IND. If, on the rare occasion the offeror does plan to hold their IND, that plan will go through DMID or OCRR for appropriate review before acceptance.

We do not expect offerors to apply with any scientific concepts. If offerors have experience with IND filing and maintenance, this should be detailed in the application.

General Please confirm the Page limit for the Technical Proposal is 150 pages for each individual Task Area.

The page limit for Task Area A is 75 pages and the page limit for Task Areas B-E is 150 pages.

Offerors shall submit separate Technical Proposals for each Task Area/Sample Task Order with the following page limitations:

75-page limit that addresses Task Area A/Task Order A 150-page limit for each Task Area B/Sample Task Order B 150-page limit for each Task Area C/Sample Task Order C 150-page limit for each Task Area D/Sample Task Order D 150-page limit for each Task Area E/Sample Task Order E

Offerors shall also submit a comprehensive Business Proposal that includes a response for each proposed task Order A + Sample Task Orders B-E.

Attachment 1, page 1 of 2

Create one PDF file of your Technical Proposal, including all attachments.

Please clarify: Is this to be one file for Task Area A and a separate file for each additional Task Area, or a single file comprising technical volumes for all Task Areas bid?

Offerors shall submit separate Technical Proposals for each Task Area/Sample Task Order with the following page limitations:

75-page limit that addresses Task Area A/Task Order A 150-page limit for each Task Area B/Sample Task Order B 150-page limit for each Task Area C/Sample Task Order C 150-page limit for each Task Area D/Sample Task Order D 150-page limit for each Task Area E/Sample Task Order E

Offerors shall also submit a comprehensive Business Proposal that includes a response for each proposed task

Attachment 10, page 7 Page 191 of 221 The proposal should address general technical requirements in the SOW for Task Areas B, C, D or E, and a separate technical response that demonstrates the capabilities, plans and procedures for carrying out the specific tasks and functions for any specific Sample Task Order requirements.

Please clarify: Is the response to the Sample Task Order to be included as a separate section, as an attachment, or as a separate file in the Technical Volume for that Task Area?

Offerors shall submit separate Technical Proposals for each Task Area/Sample Task Order with the following page limitations:

75-page limit that addresses Task Area A/Task Order A 150-page limit for each Task Area B/Sample Task Order B 150-page limit for each Task Area C/Sample Task Order C 150-page limit for each Task Area D/Sample Task Order D 150-page limit for each Task Area E/Sample Task Order E

Offerors shall also submit a comprehensive Business Proposal that includes a response for each proposed task

Attachment 10 Additional Technical Proposal Instructions, page 3 (187/221)

Technical Proposal – Table of Contents

The Technical Proposal Instructions state, “Offerors shall submit proposals in response to Task Area A, as well as one or more additional Task Area(s) that they are capable of performing. Offerors are not expected to respond to all Task Areas i.e., B, C, D, and E. Offerors responding to multiple Task Areas must provide separate Technical and Business Proposals for each Task Area.”

a. If an Offeror is proposing on Task Order A and all

Task Areas (i.e., B, C, D, and E), can the government confirm that:

Offerors shall submit separate Technical Proposals for each Task Area/Sample Task Order with the following page limitations:

75-page limit that addresses Task Area A/Task Order A 150-page limit for each Task Area B/Sample Task Order B 150-page limit for each Task Area C/Sample Task Order C

1. Offerors will submit 1 comprehensive Technical Proposal with a 150-page limit that addresses both Task Area A/Task Order A and Task Areas B, C, D, E/Sample Task Orders B, C, D, E and a Business Proposal that includes a response for Task Order A + Sample Task Orders B-E

OR

2. Four (4) separate Technical and Business Proposals – each with a Technical Proposal 150-page limit that cover the following?

i. Task Area A/Task Order A + Task Area

B/Sample Task Order B

ii. Task Area A/Task Order A + Task Area

C/Sample Task Order C

iii. Task Area A/Task Order A + Task Area

D/Sample Task Order D

iv. Task Area A/Task Order A + Task Area

E/Sample Task Order E

3. If Offerors are to complete separate Technical and Business Proposals for Task Areas B-E and assuming all Technical Proposals will have 150-page limits, how are Offerors to submit via the eCPS portal as options include an upload for a single Technical Document, a single PHS Human Subjects and Clinical Trials Document, a single Business Document? Also, the eCPS portal has a Max File Upload Size: 387.19 MB.

150-page limit for each Task Area D/Sample Task Order D 150-page limit for each Task Area E/Sample Task Order E

Offerors shall also submit a comprehensive Business Proposal that includes a response for each proposed task Order A + Sample Task Orders B-E.

If offerors encounter difficulties with entering their proposal into the system due to the size, please label your proposal Part 1, Part 2, etc.

File details come from the government source that posted it. Updated .