**Amendment #01**

"Safety Evaluation of Anti-Infective Agents"

+---------------------+------------------------------------------------+
| **Amendment Issue   | August 28, 2006                                |
| Date:**             |                                                |
+---------------------+------------------------------------------------+
| **Proposal Due      | October 11, 2006, at 3:00 P.M., EST            |
| Date/Time:**        |                                                |
+---------------------+------------------------------------------------+
| **Issued By:**      | Joshua J. LaVine                               |
|                     |                                                |
|                     | Contract Specialist                            |
|                     |                                                |
|                     | OA/DEA/NIAID/NIH/DHHS                          |
|                     |                                                |
|                     | 6700-B Rockledge Drive, Room 3214              |
|                     |                                                |
|                     | Bethesda, Maryland 20892-7612                  |
+---------------------+------------------------------------------------+
| **Points of         | Joshua J. LaVine, Contract Specialist          |
| Contact:**          |                                                |
|                     | [e-mail](mailto:JlaVine@niaid.nih.gov):        |
|                     | <JLaVine@niaid.nih.gov>                        |
|                     |                                                |
|                     | [Phone]{.underline}: Please dial               |
|                     | 1-866-410-5787 and use extension 27149         |
|                     |                                                |
|                     | to have FedVRS call me.                        |
|                     |                                                |
|                     | **Please also cc: Eileen Webster-Cissel,       |
|                     | Contracting Officer**                          |
|                     |                                                |
|                     | [e-mail](mailto:webstere@niaid.nih.gov):       |
|                     | <webstere@niaid.nih.gov>                       |
|                     |                                                |
|                     | [Phone]{.underline}: (301) 496-0612            |
+---------------------+------------------------------------------------+

**Offerors must acknowledge receipt of this [Amendment #01, for each
posting,]{.underline} 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 NOT been
extended.**

**This Amendment revises the RFP** to change the Page Limits for the
Technical Proposal to allow for submission of the
information/documentation to support the Mandatory Qualification
Criteria (compliance with Good Laboratory Practice Regulations) and for
the submission of a Health and Safety Plan as appendices that will not
be included in the 200 page limitation. ATTACHMENT 1, Packaging and
Delivery of the Proposal, and Attachment 5, Appendix A, Additional
Technical Proposal Instructions Format For Technical Proposal -- Table
of Contents, are revised. See pages 2 and 3 of this Amendment for
further details.

**ATTACHMENT 1, PACKAGING AND DELIVERY OF THE PROPOSAL, Page 2, is
revised as follows:** **PAGE LIMITS**, is hereby amended to change the
Page Limits for the Technical Proposal, to allow for submission of the
information/documentation to support the Mandatory Qualification
Criteria (compliance with Good Laboratory Practice Regulations) and for
the submission of a Health and Safety Plan as appendices that will not
be included in the 200 page limitation. These appendices shall not
exceed 100 pages in total. Page 2 is revised to read as follows:

+----------------------+---------------------------+------------------+
| **Document**         | **Number of Copies**      | **Page Limits**  |
+----------------------+---------------------------+------------------+
| Technical Proposal   | PAPER                     | Limited to       |
|                      |                           | not-to-exceed    |
|                      | One (1) unbound SIGNED    | 200 pages,       |
|                      | ORIGINAL.                 | including all    |
|                      |                           | appendices with  |
|                      | Five (5) unbound COPIES   | the exception of |
|                      |                           | the              |
|                      | ELECTRONIC FILES ON CD    | informati        |
|                      |                           | on/documentation |
|                      | Sixteen (16) Compact      | to support the   |
|                      | Disks containing an       | Mandatory        |
|                      | electronic copy of the    | Qualification    |
|                      | Technical Proposal in a   | Criteria         |
|                      | Portable Document Format  | (compliance with |
|                      | (PDF)                     | Good Laboratory  |
|                      |                           | Practice         |
|                      | \[NOTE: 1 file on each    | Regulations) and |
|                      | disk.\]                   | the Health and   |
|                      |                           | Safety Plan. For |
|                      |                           | further          |
|                      |                           | information, see |
|                      |                           | below (Technical |
|                      |                           | Proposal         |
|                      |                           | Appendices)      |
+----------------------+---------------------------+------------------+
| Technical Proposal   | PAPER                     | ALL appendices   |
|                      |                           | with the         |
| Appendices           | One (1) unbound SIGNED    | exception of the |
|                      | ORIGINAL.                 | information/     |
| Any materials not    |                           | documentation to |
| available            | Five (5) unbound COPIES   | support the      |
| electronically       |                           | Mandatory        |
| (i.e., SOPs,         | ELECTRONIC FILES ON CD    | Qualification    |
| Pertinent Manuals,   |                           | Criteria         |
| Non-scannable        | Sixteen (16) Compact      | (compliance with |
| Figures or Data, and | Disks containing an       | Good Laboratory  |
| Letters of           |                           | Practice         |
| Collaboration/Intent | electronic copy of the    | Regulations) and |
| also count in the    | Appendices in a Portable  | the Health and   |
| page limit).         | Document Format (PDF)     | Safety Plan      |
|                      | \[NOTE: 1 file on each    | shall be         |
|                      | disk.\]                   | included in the  |
|                      |                           | Technical        |
|                      | If any Appendices are not | Proposal and     |
|                      | available electronically, | within the limit |
|                      | 16 hard copies of each    | of 200 pages     |
|                      | page must be provided.    | indicated above. |
|                      |                           | The information/ |
|                      |                           | documentation to |
|                      |                           | support the      |
|                      |                           | Mandatory        |
|                      |                           | Qualification    |
|                      |                           | Criteria         |
|                      |                           | (compliance with |
|                      |                           | Good Laboratory  |
|                      |                           | Practice         |
|                      |                           | Regulations) and |
|                      |                           | the Health and   |
|                      |                           | Safety Plan      |
|                      |                           | shall be         |
|                      |                           | included as      |
|                      |                           | appendices and   |
|                      |                           | shall not exceed |
|                      |                           | 100 pages total. |
+----------------------+---------------------------+------------------+
| Business Proposal    | PAPER                     | N/A              |
|                      |                           |                  |
|                      | One (1) unbound SIGNED    |                  |
|                      | ORIGINAL.                 |                  |
|                      |                           |                  |
|                      | Five (5) unbound COPIES   |                  |
|                      |                           |                  |
|                      | ELECTRONIC FILES ON CD    |                  |
|                      |                           |                  |
|                      | One (1) Compact Disk      |                  |
|                      | containing an electronic  |                  |
|                      | copy of the Business      |                  |
|                      | Proposal in a Portable    |                  |
|                      | Document Form (PDF).      |                  |
+----------------------+---------------------------+------------------+
| Breakdown of         | This Attachment should be | N/A              |
| Proposed Estimated   | submitted also as a       |                  |
| Cost                 | separate Excel file on    |                  |
|                      | the Business Proposal     |                  |
|                      | Compact Disk.             |                  |
+----------------------+---------------------------+------------------+

**ATTACHMENT 5, APPENDIX A, Additional Technical Proposal Instructions
Format For Technical Proposal -- Table of Contents**, Page 1, is hereby
amended to reflect the change in page limitation, and shall read as
follows:

SAFETY EVALUATION OF ANTI-INFECTIVE AGENTS

NIH-NIAID-DAIDS-07-24

APPENDIX A - ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS

FORMAT FOR TECHNICAL PROPOSAL -- TABLE OF CONTENTS

+-----------------------------------------------------------------------+
| **It is strongly recommended that Offerors use the following template |
| as the Table of Contents for the technical proposal. All information  |
| presented in the technical proposal should be presented in the order  |
| specified below.**                                                    |
|                                                                       |
| The following additional technical proposal instructions reflect the  |
| requirements of the RFP and are meant to provide additional           |
| instructions as well as a uniform format for technical proposals. The |
| information requested in these instructions should be used as a guide |
| for formatting and preparing the proposal. Offerors should follow the |
| instructions in Section L of the solicitation, and include the        |
| information requested in this appendix.                               |
|                                                                       |
| Offerors are advised to give careful consideration to the statement   |
| of work, all reference material, appendices and attachments, the      |
| technical evaluation criteria, and, the RFP as a whole, in the        |
| development of your proposal.                                         |
|                                                                       |
| Offerors who propose subcontracts to perform portions of the          |
| statement of work should clearly identify the specific tasks for      |
| which they plan to utilize subcontractors, as well as the method and  |
| level of integration between the prime and subcontractor(s), and the  |
| expected advantages of such an approach.                              |
|                                                                       |
| **Offerors are reminded of the page limitations for the Technical     |
| Proposal. See Attachment 1, PACKAGING AND DELIVERY OF THE PROPOSAL,   |
| page 2.**                                                             |
+-----------------------------------------------------------------------+

**TECHNICAL PROPOSAL -- TABLE OF CONTENTS**

**SECTION 1**

I. PROPOSAL TITLE PAGE. Include RFP title and number, name of
organization, DUNS number, proposal part, and identify if the proposal
is an original or copy.

II\. PROJECT OBJECTIVES, NIH FORM 1688

III\. GOVERNMENT NOTICE FOR HANDLING PROPOSALS

IV\. TABLE OF CONTENTS

V. PROPOSAL SUMMARY AND DATA RECORD (NIH-2043)

VI\. MANDATORY QUALIFICATION CRITERIA

**SECTION 2**

**[MANDATORY QUALIFICATION CRITERIA]{.underline}**

Section M of this solicitation includes Mandatory Qualification
Criteria. **[The Mandatory Qualification Criteria must be met at the
time of the original proposal submission.]{.underline}** Information to
support compliance must be provided for the prime Contractor and any
proposed subcontractor. All Offerors must provide the requested
supporting documentation. If you fail to meet these criteria at the time
of submission of the original proposal, your proposal will not be
considered further for award. Include all information relevant to the
Mandatory Qualification Criteria in this clearly marked section of your
Technical Proposal, including copies of all materials necessary to
demonstrate that you have met the Mandatory Technical Qualification
Criteria. Offeror must demonstrate experience in conducting preclinical
safety studies in compliance with the Good Laboratory Practice
Regulations (GLP) as published in 21 CFR Part 58 (Good Laboratory
Practice for Nonclinical Laboratory Studies). A copy of the most recent
FDA GLP inspection report and the Organization\'s response shall be
provided. In addition the Offeror shall provide copies of the title and
signature pages from six (6) examples of recent reports of studies
conducted in compliance with 21 CFR Part 58, including the signature of
the Quality Assurance Officer. The Offeror shall provide documentation
of the ability