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FBO DAILY ISSUE OF DECEMBER 12, 2004 FBO #1112
MODIFICATION

68 -- Request for Information (RFI) ORDC-05-03 for Development and Manufacture of Plasma Derived Human Butyrl-Cholinesterase (HU-BChE) as a Prophylactic /Therapeutic for Exposure to Nerve Agents

Notice Date

12/10/2004
 

Notice Type

Modification
 

NAICS

325414 — Biological Product (except Diagnostic) Manufacturing
 

Contracting Office

Department of Health and Human Services, Office of the Secretary, Office of Public Health Emergency Preparedness, Office of Research and Development Coordination 200 Independence Avenue, SW Room 636G, Washington, DC, 20201
 

ZIP Code

20201
 

Solicitation Number

RFI-ORDC-05-03
 

Response Due

3/15/2005
 

Archive Date

3/30/2005
 

Description

*** BACKGROUND *** The Federal Response Plan of the Department of Homeland Security designates the Department of Health and Human Services (HHS) as the lead agency for public health and medical response to man-made or natural disasters. In 2002, HHS established the Office of Public Health Emergency Preparedness (OPHEP). This office holds responsibility for implementation of a comprehensive HHS strategy to protect from, and be prepared to respond to, acts of bioterrorism and other public health emergencies threatening the civilian population. The Office of Research and Development Coordination (ORDC) in OPHEP has the responsibility within HHS to contract with industry for large-scale manufacturing and delivery of licensable products to the Strategic National Stockpile in preparation for response to a public health emergency. ***DESCRIPTION*** This is a Request for Information (RFI) only. It is not a request for proposal and does not commit the Government to issue a solicitation, make an award, or pay any costs associated with responding to this announcement. All submitted information shall remain with the Government and will not be returned. DHHS/OPHEP/ORDC has a requirement for the acquisition and maintenance of novel therapeutic products for the Strategic National Stockpile (SNS) to treat U.S. civilians exposed to weapons of mass destruction, including nerve agents. Nerve agents include organophosphorous insecticides, soman, sarin, tabun, VX and Non-Traditional Agents (NTA's). HU-BCHE has been demonstrated to be effective as a prophylactic against nerve agent induced mortality and morbidity. HU-BChE is isolated and purified from the Cohn Fraction IV-4 of human plasma. The Government has an interest in identifying sources of GMP HU-BChE and developing capabilities for the licensure of an appropriately formulated preparation of HU-BChE for either intravenous or intramuscular injection. While proof-of-principle animal studies have been completed, additional animal challenge studies are likely needed to support the eventual licensure of the product. In responding to this RFI, indicate the proposed process for extraction and purification; potential formulations for intramuscular injection; and production capacity annually (estimate). The purpose of this RFI is to identify potential sources of HU-BChE, manufactured under a commercial scale GMP process, tested for efficacy in animal models of nerve agent exposure and for safety in human volunteers. Data obtained from this RFI will be used by DHHS in making recommendations and decisions on the development of an appropriate procurement strategy to meet the Nation's bioterrorism defense needs. Interested organizations that have candidate products are invited to submit a capability statement to the DHHS. All information submitted to DHHS will be kept confidential as allowed by relevant federal law. Information must be submitted by January 14, 2005. Responses should be limited to 25 pages and are preferred in electronic format and can be e-mailed to the attention of Darrick A. Early, phone 202-401-3693, email darrick.early@hhs.gov. Please ensure that at least TWO (2) COPIES of all responses are submitted. Under provisions laid out in the Project BioShield Act of 2004, future competition may be limited to sources responding to this request for information (Sec. 319F-2(c)(7)(C)(vii) of the Public Health Service Act, 42 U.S.C. 274d-6b).
 

Place of Performance

Address: Department of Health and Human Services, Office of Research and Development Coordination, Room 636G, 200 Independence Avenue, SW, Washington, DC

Zip Code: 20201

Country: US
 

Record

SN00719780-W 20041212/041210211710 (fbodaily.com)
 

Source

FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

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