EVALUATION OF THE TOXIC AND CARCINOGENIC POTENTIAL OF CITRAL ADMINISTERED ORALLY IN LABORATORY ANIMALS

 

NIH GUIDE, Volume 21, Number 3, Part II of II, January 24, 1992

 

RFP AVAILABLE:  NIH-ES-92-20

 

P.T. 34



Keywords:

  Toxicology 

  Cancer/Carcinogenesis 

  Dosage Forms+ 

 

National Institute of Environmental Health Sciences

 

The purpose of this contract is to evaluate the toxic and

carcinogenic potential of citral administered orally in laboratory

animals.  The base contract award will include work activities

associated with bulk chemistry, dose formulation and dose analysis

developmental work, and health and safety concerns.  The Government

may, pending the availability of funds, exercise options for:  a

study of 1,4-butanediol, a 13-week study of 1,4-butanediol, a

104-week chronic study of 1,4-butanediol, a 13-week study of citral,

and, a 104-week chronic study of citral.  Laboratory animals, that

will be used in these studies are Fischer 344/N rats and B6C3F1 mice.

These studies shall be conducted in accordance with the Food and Drug

Administration (FDA) Good Laboratory Practice Regulations as

specified in Part 58 "Good Laboratory Practices for Nonclinical

Laboratory Studies" (Federal Register, Friday, December 22, 1978,

Part II and any later interpretations published by the FDA).

 

Award of one cost-reimbursement, completion-type contract with an

estimated period of performance for the base contract of

approximately four months as a set-aside for a small business concern

is contemplated as a result of this solicitation.  Exercise of all

options under this solicitation could result in a multi-year, cost-

reimbursement type contract with a total term of five years six

months that would be incrementally funded.  All responsible sources

may submit a proposal that will be considered by the Agency.

Expected release date of the RFP is January 27, 1992 with proposals

due March 12, 1992.

 

Requests should reference RFP NIH-ES-92-20 and be forwarded to:

 

Contracts and Procurement Management Branch, OM

National Institute of Environmental Health Sciences

ATTN:  Marilyn B. Whaley, Contract Specialist

79 T.W. Alexander Drive, 4401 Building

P.O. Box 12874

Research Triangle Park, NC  27709

Telephone:  (919) 541-5770

 

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