Laboratory Support Services for the Select Agent Program

Solicitation Number: 2008-N-10233
Notice Type: Presolicitation
Synopsis: Added: February 11, 2008

The Division of Select Agents and Toxins (DSAT) in the Coordinating Office for Terrorism Prevention and Emergency Response (COTPER) in the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (DHHS), intends to compete a requirement for laboratory support services for the Select Agent Programs to furnish educated, qualified, and trained personnel to provide technical and program support in select agent and import permit activities including support of laboratory inspection activities, records, management and control, data entry, regulatory support, and file management. It is anticipated that one contract will be awarded for a one-year base period plus four one-year option periods.

Public Law 107-188, The ?Public Health Security and Bioterrorism Preparedness and Response Act of 2002,? requires that the Secretary of Health and Human Services (HHS) in cooperation with the Secretary of the United States Department of Agriculture (USDA), establish and enforce procedures for possession, use, and transfer of select agents. Select agents are biological agents and toxins that are regulated under 42 CFR Part 73 that pose a severe threat to public health and safety. The select agent regulations, 42 CFR Part 73, established requirements for facilities that possess, use, and transfer select agents.

Currently, The Centers for Disease Control and Prevention (CDC), Division of Select Agents and Toxins (DSAT) has been delegated by the Secretary of HHS to ensure compliance with the select agent regulations. These regulations are implemented so that the select agents are available for legitimate research purposes, but inaccessible to potential terrorists. To ensure compliance, CDC must inspect and evaluate entities using the requirements outlined in the select agent regulations and known biosafety standards such as the CDC/NIH (National Institutes of Health) publication, "Biosafety in Microbiological and Biomedical Laboratories" (BMBL), 29 CFR 1910.1450, ?Occupational Exposure to Hazardous Chemicals in Laboratories,? and the ?NIH Guidelines for Research Involving Recombinant DNA Molecules.?

The Public Health Service Foreign Quarantine Regulations (42 CFR, Section 71.54) govern the importation of etiological agents, hosts, and vectors of human disease into the United States. A person may not import into the United States, nor distribute after importation, any etiologic agent or any arthropod or other animal host or vector of human disease, or any exotic living arthropod or other animal capable of being a host or vector of human disease unless accompanied by a permit issued by the Director of CDC.

The CDC Etiologic Agent Import Permit Program (EAIPP) located within the Division of Select Agents and Toxins is responsible for the issuing CDC import permits. Information is submitted to EAIPP, as required by the provisions of 42 CFR 71.54, for issuance of permits by CDC to importers or distributors after importation of etiologic agents, hosts, or vectors of human disease. To carry out this provision, EAIPP has developed two forms for application for a permit. One form, the ?Application for Permit to Import or Transport Etiologic Agents, hosts, or Vectors of Human Disease? is used to request permits for the importation and subsequent distribution after importation of etiologic agents, hosts, or vectors of human disease. The second form, the ?Application for Permit to Import or Transport Live Bats? is used to request importation and subsequent distribution after importation of live bats. Issuance of the CDC import permit is essential in protecting the public?s health by monitoring the importation of etiologic agents.

Etiologic agents are those microorganisms that cause disease in humans and include bacteria, bacterial toxins, viruses, fungi, rickettsia, protozoans, and parasites. These disease-causing microorganisms may also be referred to as infectious agents. Infectious substances and biological materials, such as body fluids and tissues that contain them, are referred to as infectious materials. Organisms such as mosquitoes, ticks, or snails, that may transmit infectious diseases to animals, including humans, are called vectors.

Responses by Facsimile (Fax) will not be accepted. All vendors/prospective contractors must be registered with the Central Contractors Registration (www.ccr.gov) prior to award date. If not registered or active by that date, vendor proposals will be considered non-responsive. It is anticipated that a solicitation for this requirement will be posted to FedBizopps on or after 2/26/2008.

Inquiries may be sent to the attention of the Contract Specialist: Kristopher Lemaster, Phone 770-488-2995, email Klemaster@cdc.gov. If the Contract Specialist isn?t available, please call the Team Leader, Vivian Hubbs.

Contracting Office Address:
Department of Health and Human Services, Center for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, GA, 30341-4146, UNITED STATES

Place of Performance:
Centers for Disease Control and Prevention (CDC) Division of Select Agents and Toxins (DSAT), 1600 Clifton Road Atlanta, GA
30329

Point of Contact(s):
Kristopher Lemaster, Contract Specialist,
Phone 7704882995,
Fax 7704882670,
Email Klemaster@cdc.gov -
Vivian Hubbs, Contract Specialist,
Phone (770) 488-2647,
Fax (770) 488-2670,
Email VHubbs@cdc.gov