Loren Data's SAM Daily™

FBO DAILY ISSUE OF SEPTEMBER 16, 2004 FBO #1025
SOLICITATION NOTICE

A -- SARS experiment to explore appropriate animal model

Notice Date

9/14/2004
 

Notice Type

Solicitation Notice
 

NAICS

541710 — Research and Development in the Physical, Engineering, and Life Sciences
 

Contracting Office

Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001
 

ZIP Code

20857-0001
 

Solicitation Number

M1021304
 

Response Due

9/24/2004
 

Archive Date

10/9/2004
 

Description

The Food and Drug Administration intends to award a Purchase Order on a sole source basis to BIOQUAL, Inc., 2501 Research Blvd., Rockville, MD 20850-3228 for the utilization of their facility for a SARS Experiment. The nature of the action is the acquisition of services to maintain non-human primates under biosafety-level-three containment. To test the safety and efficacy of a vaccine for SARS, there must be an ongoing outbreak in a locale where the vaccine can be given. An alternative has been provided by the FDA, whereby the Animal Rule can be used in place of a human population. The possibility that a vaccine may cause enhancement of the disease is also troubling to FDA regulators and should be studied both in vitro and in animal models. FDA has expressed concern over vaccine safety with respect to Antibody dependent enhancement of disease (ADE). The contractor shall provide a BSL-3 facilities for human pathogen work, including SARS. Shall have performed SARS research in nonhuman primates. Must be an AAALAC, Int. accredited. Shall have an air handling system on its own air handling separate from the rest of the facility, with HEPA filtration of exhaust. The air shall provides 10-15 air changes per hour, 100% fresh air. The rooms must be able to maintained at set temperature and humidity levels as per the Guide for the Care and Use of Laboratory Animals. The animal rooms shall be negative with respect to the corridor within the BSL-3 suite, and the suite itself shall be negative with respect to the rest of the facility. Shall has an autoclave and the cagewash shall be immediately adjacent to the suite. Must have personnel with experience and training in handling a variety of animal species under BSL-3 conditions. Shall be located in a reasonable proximity to the NIH Campus in Bethesda. The building must has 24 hour / 7-day-week security guards and shall be under controlled access at all times. The building shall also have an alarm system that could inform immediately if the temperature goes outside of established limits. Must has a power generator which can tested monthly to provide emergency power in the event of an outage. Shall has staff available 24 / 7 to provide maintenance any time it is needed. An award will be made in ten (10) days from the date of this notice. This is not a request for quotes; however, sources may submit descriptive literature, which fully demonstrate their capabilities, which will be considered by the agency. This sole source procurement is being awarded as a simplified acquisition in accordance with FAR Subpart 13.5.
 

Place of Performance

Address: DHHS/FDA/CBER, Bethesda, MD

Zip Code: 20892

Country: USA
 

Record

SN00672703-W 20040916/040914211748 (fbodaily.com)
 

Source

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

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