RFP_Amendment_1_(N01TR-17-2002).pdf

“CRO Support for NCATS In Vitro and In Vivo Toxicology Studies”

Amendment of Solicitation No.: RFP N01TR-17-2002

Amendment No.: 01

Amendment date: June 23, 2016

Due Date for Proposals: Tuesday, July 19, 2016 at 3:00 PM EDT (UNCHANGED)

Issued By:

National Center for Advancing Translational Sciences NINDS R&D Contracts Management Branch NIDA Office of Acquisition National Institutes of Health Neuroscience Center 6001 Executive Boulevard Suite 3287, MSC 9531 Bethesda, Maryland 20892-9531

* For FedEx/UPS/Courier/Hand-Delivery, use Rockville, MD 20852

Primary Point of Contact: Secondary Point of Contact:

Lisa Bielen, Contracting Officer Jeffrey R. Schmidt, Contracting Officer Phone: (301) 451-7167 Phone: (301) 402-1488 E-Mail: lisa.bielen@nih.gov E-Mail: schmidtjr@mail.nih.gov

NAME AND ADDRESS OF CONTRACTOR: 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 opening hour and date specified.

PURPOSE: to respond to formal questions submitted in response to the solicitation.

All other terms and conditions of the RFP remain unchanged.

RESPONSES TO QUESTIONS

1) Question: Is the histopathological examination of tissues required for Sample Task Order 3

Study 3a (non-GLP rat study)?

Answer: No

2) Question: Is TK evaluation of plasma-drug concentration data required for Sample Task Order 3

Study 3a (non-GLP rat study)?

Answer: Yes

3) Question: Is TK evaluation of plasma-drug concentration data required for Sample Task Order 3

Study 3b (GLP rat study)?

Answer: Yes

4) Question: Is TK evaluation of plasma-drug concentration data required for Sample Task Order 3

Study 3c (non-GLP dog study)?

Answer: Yes

5) Question: It is not always apparent which studies were submitted to the FDA as part of an IND or NDA. Would it be adequate to include a list of completed GLP studies?

Answer: Yes

6) Question: Section B.3; Page 4 & Section H.20; Page 35: Section B.3 states: "The following is a list of items that may be included in the resultant contract as applicable...2) Food for Meals, Light Refreshments & Beverages". However, Section H.20 states: "...[T]he use of contract funds to purchase food for meals, light refreshments, or beverages is expressly prohibited." Please explain.

Answer: The first sentence of Article B.3 PROVISIONS APPLICABLE TO DIRECT COSTS states, “This article will prohibit or restrict the use of contract funds unless otherwise approved by the Contracting Officer.” Please note that the items listed in this Article may only be included in the resultant contract if the Contracting Officer issues written approval.

Additionally, please note that Article H.20 USE OF FUNDS FOR CONFERENCES, MEETINGS AND FOOD only applies to the disallowance of using contract funds for meetings or conferences. As such, contract funds for the purchase of meals, light refreshments, or beverages at conferences are disallowed as well.

7) Question: Section L.2.3; Page 64: This section requires the Offeror to complete the Form NIH- 2043. Can the government clarify if only one form will need to be completed at the IDIQ level or if a separate form is to be submitted for each sample Task Order Business Proposal?

Answer: Please submit one Form NIH-2043 with each copy of your Technical Proposal.

8) Question: Section M.4.b; Page 97: This section requires the Offeror to sign the FAR Clause Deviation Acknowledgement Form. Is this form to be provided as an attachment to the Technical Proposal or to the Business Proposal?

Answer: Please provide the signed FAR Clause Deviation Acknowledgment Form with each copy of your Technical Proposal.

9) Question: The RFP states the following “Provide letters of reference or customer surveys if available” in Section 6.a.3. Should responders request clients send letters directly to the COR or should the RFP response include a copy of this letter?

Answer: Please provide the letters of reference with your Technical Proposal.

10) Question: Do we understand correctly that if we are responding to each of the 3 technical areas then we are to submit them separately and you will be getting 3 originals and 30 copies of technical binders and 3 originals and 15 copies of business proposals? Or is there only 1 technical and within that we respond to each area separately (divided by tabs) and the same for the business? Then you would only be receiving the original and 10 copies of technical and the original and 5 copies of the business.

Answer: Offerors may respond to each technical area separately with tabs for both the Business Proposal and Technical Proposal.