Amendment_2.pdf

RFP Number : NIHES2012157 Amendment 2

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OFFICE OF ACQUISITIONS

NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES

REQUEST FOR PROPOSAL NUMBER: NIHES2012157

Amendment No.: 2

Date of Issuance: November 5, 2012

The above numbered Request For Proposal (RFP) is amended as set forth below. The hour and date specified for receipt of Offerors remains unchanged.

Offerors MUST acknowledge receipt of the amendment prior to the deadline for receipt of proposals, by separate letter, telegram, or Electronic Mail. The acknowledgement should include a reference to the RFP and Amendment number(s). For your convenience, the Proposal Intent Response Form is provided in SECTION J - List of Attachments of this RFP, for this purpose.

FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERORS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER.

This Amendment revises the RFP as stated below:

Amendment 2-RFP #NIHES2012157

The purpose of this amendment is to provide a clarification for the Mandatory Qualification Criteria and to revise the Government's response to Question 1 of Amendment 1.

Clarifications:

This Amendment revises the RFP as stated below:

1. Page 79 of the RFP is revised as follows:

Mandatory Qualification Criteria-Item A., GLP Compliance-Subparagraph d. now reads:

d) History (number, time-frame and evidence) of GLP studies conducted if documentation from a regulatory agency such as the above a, b or c cannot be provided. Offerors should include information that documents the depth and breadth of their expertise in conducting GLP Immunotoxicology studies. At a minimum the NTP shall be provided supporting documentation with appropriately redacted information (i.e. agent and company) to include (but not limited to): Title/Guideline Study type and respective Compliance and Quality Assurance statements sufficient to demonstrate the offeror's GLP compliance. Complete redacted reports and a current Master Schedule of ongoing GLP Immunotoxicology studies may also be included as documentation.

Additional Questions and Responses

The Government's response to Question 1 of Amendment 1 is revised as follows:

1. Regarding mandatory qualification criteria, item "d"., would the Government accept a master schedule of GLP studies including study number, protocol title, and dates? Proprietary information would have to be redacted (eg.

Company name, compound name).

Response: As stated in subparagraph d. above, Offerors should include information that documents the depth and breadth of their expertise in conducting GLP Immunotoxicology studies. At a minimum the NTP shall be provided supporting documentation with appropriately redacted

RFP Number : NIHES2012157 Amendment 2

- 2 -information (i.e. agent and company) to include (but not limited to): Title/Guideline Study type and respective Compliance and Quality Assurance statements sufficient to demonstrate the offeror's GLP compliance. Complete redacted reports and a current Master Schedule of ongoing GLP Immunotoxicology studies may also be included as documentation.