Request for Information (RFI): GLP Radionuclide Testing Facilities

Notice Number: NOT-AI-07-028

Key Dates
Release Date: March 22, 2007
Submission of Information Date:  April 30, 2007

Issued by
National Institutes of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov)

Background 

Within the Federal government, the Department of Health and Human Services (HHS) is tasked with protecting the civilian population by providing leadership in research, development, acquisition, deployment, and use of effective medical countermeasures for Weapons of Mass Destruction. This key role was identified in the National Strategy to Combat Weapons of Mass Destruction,1 Biodefense for the 21st Century,2 and National Strategy for Medical Countermeasures against Weapons of Mass Destruction,3 which together are the President’s blueprint for addressing the Nation’s Chemical, Biological, Radiological, and Nuclear (CBRN) defense programs.

To address this mission, HHS has undertaken a two-stageapproach to planning to efficiently integrate the requirements for, and the advanced development and procurement of, medical countermeasures for all CBRN threat agents.  This included publication of the draft Public Health Emergency Medical Countermeasures Enterprise Strategy (HHS PHEMCE Strategy) in the Federal Register in September 2006 (final version to be released in early 2007). In collaboration with public and private stakeholders, the HHS PHEMCE Strategy will establish the goals and objectives that HHS will use to ensure that medical countermeasures are available for effective use against the highest priority CBRN threats facing the NationThe second stage in this process is the development of the HHS PHEMCE Implementation Plan. This document will detail HHS medical countermeasure priorities for research, development and acquisition against the highest priority CBRN threats.

Radiation injury can be caused by external or internal exposure.  Internal exposure occurs when radionuclides are internalized by inhalation, ingestion, or through contaminated wounds.  The primary treatment for internal exposure involves the removal of the radionuclide in question through the administration of chelating, decorporating, or blocking agents.  On October 14, 2004, the NIH convened an expert panel to review the “NIH Strategic Plan and Research Agenda for Medical Countermeasures against Radiation and Nuclear Threats” (http://www3.niaid.nih.gov/research/topics/radnuc/planning.htm).  This strategic plan and research agenda outline a flexible, collaborative, and comprehensive NIH research and product development program focused on medical therapies and diagnostics to counter radiological and nuclear threats.  On behalf of the NIH, the National Institute of Allergy and Infectious Diseases (NIAID) is charged with implementing this research agenda and with developing medical countermeasures against radiation injury. 

A robust research and development program in this area has begun to yield new diagnostic tools, radioprotectants, and therapeutic agents to facilitate an effective response against radiation injury.   With respect to mitigating the human health consequences of internal exposures, a program to develop an oral formulation of diethylentriaminepentaacetic acid (DTPA), a radionuclide decorporation agent licensed for the treatment of plutonium, americium, and curium intoxication, has yielded initial promising results; and research has been initiated to identify and develop new and more efficacious radionuclide decorporating agents.  Further development of these decorporating agents will require facilities that can perform pre-clinical studies, potentially including inhalation toxicology studies as well as pivotal animal efficacy trials, with a range of radionuclides.  Pivotal animal efficacy trials and certain toxicology studies will need to be performed in compliance with US FDA GLP standards (21 CFR58). (http://www.fda.gov/cder/guidance/6983fnl.htm)

Description

This is a Request for Information (RFI) only.  It is not a request for proposals 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.

To support NIAID’s development of medical countermeasures against radiation injury, and to inform the HHS PHEMCE Implementation Plan,  GLP-compliant radionuclide inhalation facilities are needed to evaluate potential drug candidates and perform GLP studies to support FDA licensure.

Interested organizations that have current and potential capabilities in the following areas are invited to submit a capability statement to the NIAID.  Please submit information on existing facilities and descriptions of new facilities and instrumentation or renovations that would be required to support radionuclide studies and GLP compliance.  Facilities needs and requirements include:

Submitted information should include the current and potential capabilities of facilities to perform the following:

This Request for Information (RFI) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Government. The Government does not intend to make any award on the basis of responses nor otherwise pay for the preparation of any information submitted or for the Government's use of such information. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the Government's evaluation of the information received. However, should such a requirement materialize, no basis for claims against the Government shall arise as a result of a response to this request for information or the Government's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. Responses will be held in a confidential manner. Any proprietary information should be so marked.

Inquiries

Information must be submitted by April 30, 2007.  Responses should be limited to 10 pages and marked with this RFI identifier RFI- NOT-AI-07-028.  Responses are preferred in electronic format and can be e-mailed to the attention of the technical contact person:  

Ms. Jessica Benjamin,
Phone (301) 451-3133,
Email jmbenjamin@niaid.nih.gov

Please ensure that at least two copies of all responses are submitted: one to the technical contact person, Ms. Jessica Benjamin, and one to the primary contracting point of contact:

Ms. Wanda Neal,
Phone (301) 451-3685,
Email  wneal@niaid.nih.gov.

Inquiries regarding this notice may be directed to: 
Ms. Wanda Neal
Contracting Officer
Office of Acquisitions, DEA, NIAID, NIH, DHHS
6700B Rockledge Dr., Room 3214
Bethesda, MD  20892-7612 (Express mail:  Use Zip Code 20817-7612)
Phone 301-451-3685
Fax 301-480-4675
Email:  wneal@niaid.nih.gov

Footnotes:

1 http://www.whitehouse.gov/news/releases/2002/12/WMDStrategy.pdf
2 http://www.whitehouse.gov/homeland/20040430.html
3 http://www.whitehouse.gov/news/releases/2007/02/20070207-2.html


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