Modification_and_answers_(18-2006).pdf

Project title: “Reagent Generation for Bioanalytical Method Development for Biologics”

Amendment of Solicitation No.: RFP N01TR18-2006

Amendment No.: 01

Amendment Date: November 28, 2017

Due Date for Proposals: December 15, 2017 at 3:00 P.M. (Eastern Standard Time) (UNCHANGED)

Issued by:

National Center for Advancing Translational Sciences, NIH NIDA Office of Acquisition, NCATS Section 6001 Executive Blvd Room 3287, MSC 9531 Bethesda, MD 20892-9534

Primary Point of Contact: Secondary Point of Contact Stuart Kern, Contract Specialist Jeffrey Schmidt, Contracting Officer E-mail: stuart.kern@nih.gov E-mail: schmidtjr@mail.nih.gov Phone: (301) 402-3334 Phone: (301) 402-1488

TO ALL OFFERORS:

The above-numbered solicitation is amended as set forth below. Offerors must acknowledge receipt of this amendment on each copy of the offer submitted. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter, provided each letter makes reference to the solicitation and this amendment, and is received prior to the time and date specified for receipt of proposals.

PURPOSE: to amend RFP Attachment 4, Sample Task Order Request for Proposals (TORFP), and to respond to formal questions submitted in response to the solicitation.

All other terms and conditions of the RFP remain unchanged.

MODIFICATION

Attachment 4 to the RFP is replaced in its entirety with the modified Sample Task Order Request for Proposal (TORFP) attached to this amendment. Specifically, this modification removes the second paragraph at Attachment 4, F.3.ii, which addressed, among other things, taste masking, stability testing, and oral liquid formulation that do not apply to this RFP.

RESPONSES TO QUESTIONS

mailto:stuart.kern@nih.gov mailto:schmidtjr@mail.nih.gov

1. What is the anticipated method for determining neutralization activity?

The methods for the determination of neutralization activity will be project specific and based on the drug's mechanism of action. In general, a cell based activity assay is anticipated to be used. NCATS will transfer the cell activity assay to the vendor when such an assay is available.

2. Who will be performing the neutralization determination assays?

It is anticipated that the vendor will perform the neutralization determination assays on samples collected from PK studies. Neutralizing antibody assays are needed for clinical studies, but in most cases are not needed for pre-clinical studies. In preclinical studies a combination of PK, TK and ADA binding assays may be used to infer whether or not the ADA response is neutralizing.

3. Can we get additional specifications for “Implement and maintain administration of data management systems”?

NCATS does not prescribe any particular data management system. Rather, data management systems (as referred to in the Task Order Request for Proposals) should comply with the general IT clauses elsewhere in the RFP. Refer to the requirements for confidentiality, integrity, and availability identified in Section H.10, and the requirements for reports and record keeping in the RFP and the Statement of Work, including batch records and other records related to reagent production.

4. The General Instructions state that the Government anticipates awarding both cost-reimbursement and fixed-price task orders (Section L.1 and L.2.a.1.), but the Business Proposal Instructions state that task orders will not be firm-fixed-price (Section L.2.c.8.d). Please clarify.

Task orders may be either cost-reimbursement or firm-fixed-price, depending on which approach is fair and reasonable while providing best value to the Government. The Government’s preference is to make firm-fixed-price awards, but offerors may propose a cost-reimbursement basis at their discretion.