BAA Special Instructions Amendment 4.doc

AMENDMENT TO BARDA BROAD AGENCY ANNOUNCEMENT

ADVANCED DEVELOPMENT OF CHEMICAL, BIOLOGICAL, RADIOLOGICAL, AND NUCLEAR MEDICAL COUNTERMEASURES

Broad Agency Announcement Number:

BAA-BARDA-09-34

Amendment Number:

Four (4)

Amendment Posting Date:

June 30, 2009

Issued By:

Biomedical Advanced Research and Development Authority (BARDA)

330 Independence Ave., SW, Room G640

Washington, D.C. 20201

Point of Contact:

Primary: Glynis Fisher, Contract Officer glynis.fisher@hhs.gov

Alternate: Jeannett Jackman, Contract Specialist jeannett.jackman@hhs.gov

SUMMARY OF CHANGES

A. PURPOSE: The purpose of these special instructions is to specifically solicit solutions for treating cutaneous and/or pulmonary (life-threatening pneumonitis and fibrosis) injuries resulting from exposure to ionizing radiation.

(1) The date for receipt of white papers under these special instructions is August 31, 2009.

(2) Questions from industry regarding the special instructions may be emailed to CBRN-BAA@hhs.gov no later than July 15, 2009.

(3) A Pre-Proposal conference will be held August 5, 2009, particulars follows the special instructions.

(4) The Broad Agency Announcement (BAA) date specified for receipt of proposals remains unchanged. Except as provided herein, all terms and conditions of the BAA remain unchanged.

Special Instructions – Cutaneous and Pulmonary Injury from Ionizing Radiation

The purpose of these special instructions is to specifically solicit solutions for treating cutaneous and/or pulmonary (life-threatening pneumonitis and fibrosis) injuries resulting from exposure to ionizing radiation. As part of the proposed SOW, BARDA is interested in advanced development and eventual licensure/approval of medical countermeasures for cutaneous and/or pulmonary injuries resulting from an acute exposure to radiation from a radiological/nuclear accident or attack, particularly injuries associated with ARS or DEARE (Research area 4).

As part of the proposed SOW, BARDA is interested in advanced development and eventual licensure/approval of medical countermeasures for cutaneous and/or pulmonary injuries resulting from an acute exposure to radiation from a radiological/nuclear accident or attack, particularly injuries associated with ARS or DEARE (Research area 4).

BARDA is seeking safe and effective medical countermeasures that mitigate, treat, affect, delay, or interrupt the progression of cutaneous and/or pulmonary injury caused by ionizing radiation. Proposals should include development or use of a model for a radiation setting with consideration of delaying administration of the medical countermeasure, as is anticipated for large catastrophic incidents. Proposals to examine treatment effects on cutaneous injuries caused by thermal, microwave, UVA, UVB, UVC, or other non-ionizing sources of radiation are not responsive. BARDA will give high priority to proposed solutions that are already licensed/approved for other indications and that may be suitable/adaptable for development for ARS/DEARE indications.

In alignment with the PHEMCE Implementation Plan, HHS will prioritize the development and acquisition of medical countermeasures that are associated with an effective concept of operations (CONOPs). For planning purposes, the ground burst detonation of a 10-kiloton (kT) improvised nuclear device (IND) in a large metropolitan locale has been modeled and used to calculate effects on the surrounding population. Response activities in this environment, with a severely compromised infrastructure and damage to local healthcare systems for the first few days (e.g., 24 – 96 hours), will place severe limitations on early provision of medical countermeasures to treat the great number of expected victims. Federal personnel might not be able to arrive until 24 hours following the incident and medical treatments and diagnostic tools that must be brought in from outside the immediate area may not be fully available for 36 hours. Proposals should include a consideration of how the proposed therapeutic agent would be used in such a setting, and should address its utility for use 24 hours or more after the incident. More information on the response parameters (or CONOPs) for such an incident are described in the Homeland Security Council’s Planning Guidance for Response to a Nuclear Detonation (available on-line at http://www3.cancer.gov/rrp/planningguidanceforresponse.pdf ).

INSTRUCTIONS:

Quad Chart and White Paper will be accepted no later than close of business on August 31, 2009 for consideration. A pre-proposal conference will be held Wednesday, August 5, 2009, 9:00am – 11:00am at

Mary E. Switzer Building

330 C. Street, S.W., Conference Room 3005

Washington, DC 20201 Please note the following regarding the pre-proposal conference:

1. Enter the Switzer Building at the C Street entrance.

2. Arrive 30 minutes early to allow time to clear security.

3. Bring your identification

4. The closest metro stop is Federal Center SW

5. Attendance is limited to a maximum of two (2) people per company. Email the names of your attendees to CBRN-BAA@hhs.gov by July 30, 2009.

6. Tape recorders and videos are prohibited.

7. Minutes of the conference will be posted on FedBizOpps in an amendment to the BAA approximately 1 week after the pre-proposal conference

NOTE: For those who are unable to attend, please use the following dial-in information: 1-866-917-6472 Participant code # 7938647.