RFP-2012144-_Amendment_4.pdf

RFP NIAID-DMID-NIHAI2012144

Amendment #4

“VACCINE AND TREATMENT EVALUATION UNITS (VTEU)”

Amendment Issue Date: September 22, 2012

Proposal Due Date/Time:

October 4, 2012., at 3:00 P.M., local time

[Changed]

Issued By: Michael C. Finn

Contracting Officer

OA/DEA/NIAID/NIH/DHHS

6700-B Rockledge Drive, Room 3214, Bethesda, Maryland 20892-7612

Points of Contact: PRIMARY:

ryanes@niaid.nih.gov

E. Shane Ryan, Contract Specialist

Phone: 301-451-3692

SECONDARY:

aileene.mitchellford@nih.gov

Aileene Mitchell Ford, Contracting Officer

Phone: 301-496-7288

Offerors must acknowledge receipt of this Amendment on each copy of the proposal submitted. Failure to receive your acknowledgment of this Amendment may result in the rejection of your proposal.

The hour and date specified for receipt of proposals HAS been extended to October 4, 2012.

General Notes;

1. The following question and response appeared in Amendment #2 (number 17). The response for this question has been changed to the following:

17. Pg 73. Data and Safety Monitoring in Clinical Trials

Q: Is the offeror expected to identify DSMB members for trials or is this done in conjunction with/or by DMID?

Response: This is done in conjunction with DMID. DMID is responsible for making the final decision, but the offeror is expected to suggest names of qualified candidates after award.

(Please remove any names that may appear in your proposal until the NIAID request this information after award.)

mailto:ryanes@niaid.nih.gov mailto:aileene.mitchellford@nih.gov

FAQ’s and RESPONSES

1. How does the Total Compensation Plan (RFP page 92-93) differ from the salary and fringe information provided in the Cost Summary and Breakdown of Proposed Estimated Costs Excel

Spreadsheet?

Response: Each Offeror is to provide detailed information concerning their compensation plan.

2. If we have plans to upgrade all of its computers to Windows 7 over the next several months. We noticed that the RFP only mentions Windows XP and Vista in "Standard for Security

Configurations, HHSAR 352.239-70, (January 2010)".

Is Windows 7 approved for VTEU systems processing data as long as USGCB/FDCC recommendations are used in the development of the standard system deployment and operating system and anti-virus updates are installed in a timely manner?

Response: Yes, Windows 7 requires USGCB compliance; whereas, XP and Vista require FDCC compliance.

3. The reference to clinical trial insurance meant to indicate a policy that would cover: no fault research-related injury; negligence; or both?

Response: No fault research-related injury.

4. The requirement referring to an annual aggregate limit, or to an annual per occurrence limit?

Response: Aggregate limit

5. Does the government intend us to cover injuries caused by the product? For example, we administer the medication according to the protocol but something in the vaccine developed by the third party causes injuries. In this case, the VTEU institution did not do anything wrong, it was the something inherent to the product that caused injury and additional expense."

Response: The Government does not intend to cover injuries caused by the product.