STUDIES TO EVALUATE THE HEALTH EFFECTS OF CHEMICALS IN DEVELOPING ANIMALS FOR 
THE NATIONAL TOXICOLOGY PROGRAM

Release Date:  June 12, 2001

NOTICE:  NOT-ES-01-007

RFP NIH-ES-01-10

National Institute of Environmental Health Sciences

The NIEHS is soliciting offers for a contract to conduct studies which
will assist the National Toxicology Program (NTP) in evaluating the 
effects of exposure to chemicals during critical phases of development 
which may result in long term alterations in reproductive, 
neurological, and/or immunological endpoints.  As a general approach, 
the treatment period could be as broad as to include exposure of 
pregnant dams (rats or mice) followed by direct exposure to the 
offspring for as long as puberty (PND42), at which point dosing may 
cease in some studies and in other cases the dosing may be longer.  
Animals destined for autoimmunity endpoints may be housed for a 
specified time period up to one year.  Measures for reproductive 
toxicity, immunotoxicity and neurotoxicity may be collected from the 
same animals or may require different animal groups.  A chemical-
specific protocol outline will be provided by the Government for each 
chemical studied under this contract.  The types of chemicals to be 
studied may include but shall not be limited to industrial solvents, 
plasticizers, food preservatives and colorants, drugs, pesticides, and 
heavy metals.  In general, studies shall involve daily (gavage) or 
continuous (dosed feed or water) dosing periods or in rare cases 
subcutaneous/intraperitoneal injection of rats or mice. Treatment 
regimens, species used, endpoints to be measured etc. shall vary 
depending on specific chemicals to be tested and study goals. Offerors 
should be aware that the actual mix of studies would vary each year 
according to the types of chemicals selected for study.   It is 
anticipated that approximately the followings mix of studies shall be 
conducted each year.  Two range finding perinatal toxicity studies one 
by the gavage route and another by either dosed feed, or dosed water in 
rats or mice.  Two definitive perinatal toxicity studies by gavage, 
dosed feed or drinking water to evaluate neurologic and reproductive 
function in rats or mice.  Two definitive perinatal toxicity studies by 
gavage, dosed feed or drinking water to evaluate neurobehavioral and 
immunologic function in rats or mice.  The Government may, depending on 
need and availability of funds, exercise one option in each year of the 
contract for the conduct of one additional range finding study and up 
to two definitive studies (one Definitive Perinatal Toxicity study for 
Neurologic and Reproductive Function, and one Definitive Perinatal 
Toxicity study for Neurobehavioral and Immunologic function.) similar 
to the ones in the base contract.  The contractor shall conduct studies 
in accordance with the general requirements and recommendations for lab 
animal management contained in "Specifications for the conduct of 
studies to evaluate the toxic and carcinogenic potential of chemical, 
biological and physical agents in laboratory animals for the National 
Toxicology Program" dated September 2000.   The Offeror shall have a 
working laboratory in place by the date of proposal submission.  The 
Principal Investigator, Toxicologist, Chemist, Veterinarian, Health and 
Safety Officer and Quality Assurance Unit Officer shall be employees of 
the contract laboratory (i.e., not consultants or subcontractors).  The
daily interaction and constant coordination of efforts needed amongst
these discipline areas throughout the in-life portion of the studies
makes it critical that they be physically and organizationally
together.  Award of one cost-reimbursement, level of effort type
contract on February 28, 2002 on an open competition basis is
contemplated as a result of this solicitation.  The estimated level of
effort is 173,500 hours for the base contract and 86,750 labor hours
for all options.  The estimated period of performance is five years
for the base contract (and if all options are exercised).   Interested
organizations should telefax a request for RFP NIH-ES-01-10 to the
attention of Ms. Melissa Pittman, Procurement Technician at  (919)
541-2712 or send an e-mail request to [email protected]. The
electronic version of the CBD synopsis is available on the Internet
at:http://www.niehs.nih.gov/dert/rcb/rfp.htm.  An electronic copy of
the RFP will be posted to this site on or about June 22, 2001.  All
responsible sources may submit a proposal which shall be considered by
the Agency.  Expected release date of the RFP is June 22, 2001 with
proposals due August 7, 2001.  This requirement is unrestricted.  The
NAICS is 541710.

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