2014013__Amendment_1final.pdf

AMENDMENT #1, RFP NIAID-DAIDS-NIHAI2014013

Amendment No. 1 Solicitation Notice

RFP-NIAID-DAIDS-NIHAI2014013

“NIAID Process and Analytical Support for Development of HIV Vaccines”

Solicitation Number:

Amendment Number:

Amendment Issue Date:

RFP-NIAID-DAIDS-NIHAI2014013

One (1)

July 7, 2015

Proposal Intent Response Sheet:

Response Date:

Friday, July 31, 2015 at 3:00 PM, Local Time (Changed)

Thursday, September 17, 2015 at 3:00 PM, Local Time (Changed)

Issued By: Michelle L. Scala Contracting Officer

OA/DEA/NIAID/NIH/DHHS

5601 Fishers Lane, Room 3D10, MSC 9821 Bethesda, Maryland 20892-9821

Points of Contact: PRIMARY:

Kim.Brookens@nih.gov Kim Brookens, Contract Specialist Phone: 301-761-5140

SECONDARY:

mscala@niaid.nih.gov Michelle L. Scala, Contracting Officer Phone: 240-669-5156

The purpose of this amendment is to answer questions from potential offerors regarding the solicitation, revise Attachment 3, Base Statement of Work, Section C.2.a., extend the proposal submission deadline, and extend submission due date for the Proposal Intent Response Sheet.

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.

mailto:Kim.Brookens@nih.gov mailto:anhughes@niaid.nih.gov

Questions from Potential Offerors:

Question 1:

Under C.1. Process Development, Scope: Is the intent of “Parallel formulation activities shall be developed for adjuvant compatibility.” that we should be concurrently developing an adjuvant or that we should conduct formulation activities with available adjuvants?

Response to Question 1:

This RFP does not include the development of novel adjuvants. If formulation work that involves an adjuvant is requested under Task Area 3, the adjuvants will be specified.

Question 2:

Under C.2. Requirements: We would like to propose a novel technology for env protein production. Must we also propose “use of a current technology”?

Response to Question 2:

Under Attachment 3, Section 4) C.2. Requirements for Task Area 3; documented expertise and prior success with current technologies that are widely used in the industry for production of recombinant viral proteins will be required for this contract. The contract is not intended to support very early research studies of novel technologies. Novel technologies that have a level of demonstrated feasibility for clinical manufacturing may be supported by this contract.

Question 3:

Is the env protein the only target anticipated, or would process development for other HIV proteins be of interest?

Response to Question 3:

The contract may be used to provide support for the development of other HIV proteins that have been demonstrated to be potentially valuable as vaccine candidates.

Question 4:

Under C.2.a.iii: Must we propose the use of transient cell lines AND cell-free protein production?

Response to Question 4:

The bidder should describe their level of expertise with these technologies.

Solicitation Clarification:

Attachment 3, Section C.2.a., is revised to read as follows:

2. Requirements for Task Area 3:

a. Upstream Activities may include but are not limited to

Develop cell lines with high expression levels of Env protein, through use of current and novel technologies intended to improve recombinant protein production.

i. Prepare cell banks or appropriate research materials that can be used for subsequent GMP activities

ii. Develop approaches for rapid screening and identification of mammalian cell lines expressing HIV Env protein

PROPOSAL INTENT RESPONSE SHEET Page 1 of 1 ATTACHMENT 2

PROPOSAL INTENT RESPONSE SHEET

NIAID PROCESS AND ANALYTICAL SUPPORT FOR DEVELOPMENT OF HIV VACCINES

RFP-NIAID-DAIDS-NIHAI2014013

Please review the attached Request for Proposal. Furnish the information requested below and return this page by July 31, 2015. Your expression of intent is not binding but will greatly assist us in planning for proposal evaluation.

[ ] DO INTEND TO SUBMIT A PROPOSAL

[ ] DO NOT INTEND TO SUBMIT A PROPOSAL FOR THE FOLLOWING

REASONS:

Company/Institution Name (print): ______________________________________

Address (print): _______________________________________________________

Project Director's Name (print): ________________________________________

Title (print): _________________________________________________________

Signature/Date: ________________________________________________

Telephone Number and E-mail Address (print clearly):

*Name of individual to whom electronic proposal instructions should be sent:

Name: ___________________________________________________

Title: ___________________________________________________

E-Mail Address: __________________________________________

Telephone Number: _______________________________________

Names of Collaborating Institutions and Investigators (include Subcontractors and Consultants)

(print):

(Continue list on a separate page if necessary)

RETURN VIA FAX OR E-MAIL TO:

OA, DEA, NIAID, NIH

5601 Fishers Lane, Room 3D10, MSC 9821

Bethesda, MD 20892-9821

Attn: Rosemary Gomes

RFP No. NIAID- DAIDS-NIHAI2014013

FAX# (240) 627-3152

Email: rosemary.gomes@nih.gov mailto:rosemary.gomes@nih.gov