NOT-HD-01-008: BIOLOGICAL TESTING FACILITY

Department of Health
and Human Services (HHS)
NIH... Turning Discovery Into Health^®


BIOLOGICAL TESTING FACILITY

Release Date:  August 30, 2001

NOTICE:  NOT-HD-01-008

National Institute of Child Health and Human Development
 (http://www.nichd.nih.gov)

RFP AVAILABLE:  NIH-NICHD-2001-05

The National Institute of Child Health and Human Development (NICHD) has 
issued a Request for Proposals (RFP) to recompete its contract for a 
Biological Testing Facility (BTF).  The BTF program is designed to permit 
rapid evaluation of new compositions of matter, drug formulations, delivery 
systems, and devices for anti-fertility and endocrine activity.  Such 
evaluations require the availability of a broad spectrum of in-house 
biological tests, assays, and analytical procedures.  These include anti-
fertility tests in male and female animals, bioassays, mechanism of action 
studies, radio-immunoassays of steroid and protein hormones, radio-receptor 
assays, pharmacokinetic studies and drug safety evaluations.  Requirements for 
this project include:  (a) in-house capability to maintain 2000 rodents, 200 
rabbits, and 50 non-human primates at any one time in facilities that meet all 
local, state and federal regulations, (b) individuals with experience in 
conducting studies under Good Laboratory Practice (GLP) guidelines, as needed, 
(c) experience, capability and facilities to undertake a wide variety of in 
vitro transcriptional assays using various cell lines and expression plasmids, 
(d) capability of handling proprietary materials, conduct data analyses by 
standard methods, enter data into Government-furnished data management systems 
and prepare reports that are acceptable in format and content for submission 
to the Food and Drug Administration (FDA) in support of a Notice of Claimed 
Investigational Exemption for a New Drug (IND).

The required service is defined as code 541710 under the North American 
Industry Classification System (NAICS).  

All responsible sources may submit a proposal for consideration.  In order to 
be considered for evaluation, potential offerors must meet the following five 
mandatory requirements at the time of proposal submission:  (1) in-house 
capabilities and technical staff to undertake endocrine assays, reproductive 
tests, pharmacokinetic studies, and in vitro transcriptional and gene 
expression profiling studies, (2) facilities for housing rodents, rabbits, and 
rhesus monkeys in individual cages, animal rooms for these species must be 
separate and dedicated to the use of this contract, (3) current certification 
from the Association for the Assessment and Accreditation of Laboratory Animal 
Care (AAALAC), and conformance to the standards outlined in the Revised Guide 
for the Care and Use of Laboratory animals (NIH guide:  
http://grants.nih.gov/grants/guide/notice-files/not96-208.html) and the Animal 
Welfare Act of 1966 and amendments thereto, (4) an on-site Radiation Safety 
Officer and current, appropriate licenses for handling radio-chemicals and 
controlled substances, (5) dedicated personnel with the following commitments:  
Principal Investigator, full-time, Biochemistry Manager, one full-time, 
Biological Assay Manager, one full-time, Bioassay Technicians, three FTEs, 
Biochemistry Technicians, two FTEs, and Animal Caretakers, four FTEs.  This 
advertisement does not commit the Government to award a contract. 

It is anticipated that one cost-reimbursement option type contract will be 
awarded as a result of the Request for Proposals (RFP) and the contract is 
anticipated to have a duration of five years.  The RFP represents a re-
competition of a project currently being performed by Bioqual, Inc. of 
Rockville, MD.   

The Request for Proposals (RFP) is available at 
http://www.nichd.nih.gov/oam_cmb.   Proposals are due by 4:00 PM EST on 
October 15, 2001.  

Proposals should be submitted to:

Virginia A. DeSeau
Contracting Officer
Contracts Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Suite 7A07, MSC 7510
Bethesda MD 20892-7510
Telephone:  (301) 496-4611
FAX:  (301) 402-3676
E-mail:  [email protected]
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