Amendment 2 Preproposal Conference Slides Final.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE PAGE OF

1 2

AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE 4.

REQUISITION/PURC

HASE REQ. NO.

5. PROJECT NO. (If applicable)

0002 10/15/2010 N/A

6. ISSUED BY CODE 7. ADMINISTERED BY (If other than

Item 6) Code

DHHS/ASPR/AMCG

330 Independence Ave, SW, RM G-640 Washington, DC 20201

See Item 7

8. NAME AND ADDRESS OF CONTRACTOR (No. street, county, State and ZIP Code) () 9.A. AMENDMENT OF SOLICITATION NO.

BARDA 10-100-SOL-00025

N/A 9.B. DATED (SEE ITEM 11)

9/17/2010 10.A. MODIFICATION OF Contract/Order

NO.

10.B. DATED (SEE ITEM 13)

CODE N/A FACILITY CODE N/A

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended. Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods: (a) By completing Items 8 and 15, and returning copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT 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 telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required) N/A

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

() A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE

IN THE CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority

E. IMPORTANT: Contractor is not, is required to sign this document and return ___ copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section heading, including solicitation/contract subject matter where feasible.)

Revisions to BARDA 10-100-SOL-00025 are set forth in the Summary of Changes

15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

Darrick A. Early

15B. CONTRACTOR/OFFEROR 15C. DATE

SIGNED

16B. UNITED STATES OF AMERICA 16C. DATE

SIGNED

BY

(Signature of person authorized to sign (Signature of Contracting Officer)

NSN 7540-01-152-8070 30-105 STANDARD FORM 30 (REV 10-83)

PREVIOUS EDITION UNUSABLE Prescribed by GSA

FAR (48CFR) 563.243

SUMMARY of CHANGES

This amendment is issued to post the PowerPoint presentation from the Pre-proposal Conference and to make revisions to the solicitation.

a. Standard Form 33, block 9 the due date for proposals and the cutoff time remains unchanged.

b. Item H.3. Laboratory License Requirements, page 30 is not applicable to this solicitation and is hereby removed.

c. Item H.13. Human Subjects, page 34 is not applicable to this solicitation and is hereby removed.

d. Item H.14. Continued Ban of Funding of Human Embryo Research, page 34 is not applicable to this solicitation and is hereby removed.

e. Section L under III.Technical Proposal Instructions, page 56, is revised to read “the technical proposal may not exceed 50 pages per area (Chem, Bio, and/or Rad/Nuc), including Option year descriptions.” Technical appendices should not exceed a total of 50 pages for all technical areas proposed.

f. Offerors should use instructions for the Business Proposal Cover Page in Section L, Page 58. Attachment 3 is hereby removed.

g. Attachment 2, Table Page Limits under Technical Written Proposal should read, “Written Proposal Not-to-exceed 50 pages per area for Technical proposal and a total of 50 pages for Technical appendices.”

h. M.5. Page 66, Item 4 should state, "In response to the attached SOW (Attachment 14), please provide the following…"

i. Attachment 14, The Sample Task Order Statement of Work for Biological should read as follows:

The example statement of work is to provide the USG with a uniform basis of technical study design and cost.

Although the example task order originally included in the RFP is the determination of the LD50 of an aerosol challenge of Bacillus anthracis (Ames strain) in cynomologus monkeys, the USG recognizes that not every organization has the capability to conduct aerosol, NHP, or anthrax studies. Consequently, the Offeror should design an LD50 study with the following criteria:

A. Statement of work – Biological:

1. Determine the lethal Dose – 50 ( ) for an agent identified in the PHEMCE Implementation Plan (https://www.medicalcountermeasures.gov/BARDA/PHEMCE/enterprise/strategy/strategy.aspx).

2. Animal model: Select an appropriate species and provide justification in the study design

3. Exposure route: select the route of exposure and provide justification for the route of exposure

4. Define the statistical sensitivity and variability of the determination

Assumptions

1. The challenge agent will be available and characterized

2. No necropsies

3. No additional chemical/biochemical analysis

4. Non-GLP

i. Except as provided herein, all terms and conditions of the RFP remain unchanged.

https://www.medicalcountermeasures.gov/BARDA/PHEMCE/enterprise/strategy/strategy.aspx