Modification_and_answers_No._2_(18-2006).pdf

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

Amendment of Solicitation No.: RFP N01TR18-2006

Amendment No.: 02

Amendment Date: December 7, 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 confirm that the development of bioanalytical assay reagents under this solicitation is a non-GLP/non-GMP activity (as stated in Attachment 3, Statement of Work), and to remove the requirement in the Sample Task Order Request for Proposal (TORPF) (Attachment 4) that respondents show that facilities are appropriate for handling drug products under cGMPs.

All other terms and conditions of the RFP remain unchanged.

MODIFICATION

RFP Attachment 4, Paragraph 6.i., which reads “The facilities are appropriate for handling clinical grade Drug Products under cGMPs,” is removed.

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