Vaccine (and other biologic) manufacturing services for infectious diseases

Closed Solicitation Posted

This opportunity was awarded. See its 6 award notices in the notice history.

Solicitation number
75N93024R00004
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Notice details come from SAM.gov. Updated .

About this opportunity

The Department of Health and Human Services' National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID) is seeking proposals for vaccine and biologic manufacturing services to support the development of new vaccines and biologics against infectious diseases. The objective is to provide a suite of product development services, including preclinical development support, optimization, process development, manufacturing, characterization, and support for early-stage clinical trials. Proposals will be evaluated based on the appropriateness and adequacy of the offeror's facilities, equipment, space, and other resources. The solicitation has a proposal due date of May 17, 2024.

This is a multiple-award indefinite delivery, indefinite quantity (IDIQ) contract with a minimum value of $10,000 and a maximum value of $48,000,000. The period of performance is May 1, 2025 through April 30, 2035. There is no set-aside designation, and the solicitation is open to all qualified offerors. The place of performance is not specified, but offerors must have the necessary facilities and resources to provide the required services.

Notice text

5 versions

Update #5 · Latest ·

Purpose of Solicitation Amendment 4:

1. To delete ARTICLE H.17. ELECTRONIC AND INFORMATION TECHNOLOGY

    ACCESSIBILITY NOTICE HHSAR 352.239-73 (December 2015).

2.  To renumber H ARTICLES 17-27

3. To amend the following underARTICLE I.4. ADDITIONAL FAR CONTRACT

    CLAUSES INCLUDED IN FULL TEXT:

  • Under paragraph 10. FAR Clause 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (Jan 2022)I is deleted and replaced with FAR 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026.  (APR 2024).
  • Paragraph 12 is added to include FAR Clause 52.204-71, Information and Information Systems Security (FEB 2024)

4.  To amend the following under SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO

     OFFERORs:

  • 2.a.16. is amended to delete Electronic and Information Technology Accessibility Notice, HHSAR 352.239-73 (December 2015) and replace with Information and Communication Technology Accessibility Notice, HHSAR 352.239-78 (Feb 2024).
Update #4 ·

Purpose of Solicitation Amendment 3:

  1. To respond to questions received regarding the solicitation.
  2. To remove Task Area A Sample Task Order from Attachment 5-Sample Task Orders.
  3. To revise Attachment 1-Package and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website, as follows:

B. Page Limitations:

1. The total page count of the Technical proposal shall not exceed: Amend RFP

a. Task Area A: 25 pages

b. Task Area B: 40 pages for 1 Sample Task Order and 55 pages for 2 Sample

    Task Orders

c. Task Area C: 45 pages for 1 Sample Task Order and 60 pages for 2 Sample

    Task Orders

d. Task Area D: 45 pages for 1 Sample Task Order and 60 pages for 2 Sample

    Task Orders

                    2. Total page count does not include:

                        c.   Floorplans

  1. b. TECHNICAL PROPOSAL INSTRUCTIONS, b. Personnel, Resumes is replaced with the following:
  2. Biosketches

Biosketches of all key personnel are required. Each must indicate educational background, recent and specific experience, specific or technical accomplishments, and a listing of relevant publications if appropriate. (Pg. 84 of RFP)

     5.    ATTACHMENT 5-SAMPLE TASK ORDERS, TASK AREA B-2 is revised as follows:

            3) TECHNICAL REQUIREMENTS

                 E)    Manufacture and Characterization of 2 lots of material:

                          1. Non-Clinical inactivated virus test article

            4)  OTHER TECHNICAL REQUIREMENTS AND ASSUMPTIONS

                 C)  The Offeror shall formulate and fill the virus in a manner appropriate for use as a   preclinical test article (vaccine candidate).

6.    ATTACHMENT 07: ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS,  

       FORMAT FOR TECHNICAL PROPOSAL, and TABLE OF CONTENTS, is revised as

       follows:

SECTION 1: TITLE PAGE AND INTRODUCTIONS (No page limit)

SECTION 3: KICKOFF TASK ORDER AND SAMPLE TASK ORDER PROPOSALS (15

page maximum for each sample task order)

TECHNICAL INSTRUCTIONS

SECTION 3: KICKOFF TASK ORDER AND SAMPLE TASK ORDER PROPOSALS

Personnel:

Provide information relevant to document individual training, experience, qualifications and expertise necessary for the successful completion of all Task Order requirements. Include key personnel from proposed subcontractors. Limit biosketches to 1 page. Please note that the biosketches will not be included in the page limit.

Update #3 ·

The purpose of Amendment No. 2 is to extend the proposal submission deadline to May 17, 2024.

I. The proposal submission deadline is extended to Friday, May 17, 2024.

Solicitation cover page change:

8. Proposals for furnishing the supplies and/or services stated in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, “Packaging and Delivery of the Proposal,” until 2:00 PM local time on Friday, May 17, 2024. Offers will be valid for 120 days, unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043.

Update #2 ·

Amendment No. 1: to amend Attachment 1 - Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website

II.        FORMATTING AND PAGE LIMITATIONS

B.        Page limitations:

1.         The total page count of the Technical proposal shall not exceed:

a.         Task Area A: 50 pages

Update #1 ·

VACCINE (AND OTHER BIOLOGIC) MANUFACTURING SERVICES FOR INFECTIOUS DISEASES

Files

File Type Posted
RFP 75N93024R00004 Amend 4.pdf PDF
Amendment No. 4 Cover.pdf PDF
RFP 75N93024R00004 Amend 3.pdf PDF
RFP 75N93024R00004 Questions-Responses.pdf PDF
Amendment No. 3 Cover.pdf PDF
Amendment No. 2.pdf PDF
RFP 75N93024R00004 Amendment 2.pdf PDF
Amendment No. 1.pdf PDF
RFP 75N93024R00004.pdf PDF

Notice history

6 of 9 notices listed here. See the rest on GovTribe.

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