NIH GUIDE, Volume 24, Number 33, September 22, 1995


P.T. 34


  Chemical Synthesis 

  Chemistry, Organic 

  Chemistry, Analytical 

National Institute of Child Health and Human Development

The Contraceptive Development Branch of the Center for Population

Research, National Institute of Child Health and Human Development

(NICHD), has a requirement for the maintenance and operation of a

synthetic chemical facility for the synthesis of anti-fertility

agents on a laboratory scale (1-5 grams) as well as on a relatively

large scale (1,000 grams).  The maximum quantities of any final

product to be prepared by multistep synthesis via batchwise

operations will not normally exceed 1000 grams.  It is desirable that

Offerors have expertise in the synthesis of a variety of optically

active steroids, steroid-protein conjugates as immunogenic agents for

radioimmunoassay as well as their tracers to be radiolabelled with 3H

and 125I, a wide variety of unnatural amino acids including

resolution work, stereoselective synthesis, and determination of

their optical purity, radiolabelled compounds for metabolism studies,

heterocyclic, carbocyclic and other non-steroidal compounds that may

be of significance to the contraceptive development program.  In

addition, the capability to perform High Performance Liquid

Chromatography (HPLC) analysis for the detection and quantification

of circulating drugs in serum, urine and feces from animals, and to

perform analytical working order to assess the purity of compounds,

is also desirable.  Specific assignment of compounds and quantities

to be prepared will be determined by the Project Officer.  Major

emphasis will be on the preparation of experimental compounds on a

laboratory scale (1-5 grams).  As minimum requirements, organizations

must have the following in-house equipment (or indications of

anticipated purchase of same): Ultraviolet, infrared and 1H and 13C

nuclear magnetic resonance spectrometers (90-100 MHZ), mass

spectrometer, polarimeter, gas chromatography, analytical high

performance liquid chromatography preferably equipped with an

integrator and preparative high performance liquid chromatography

that can provide gram quantities of purified compounds.  The

Government does not intend to furnish any of the above equipment or

facilities.  The offeror's facilities must meet requirements for

current Good Manufacturing Practices (cGMP) and must meet

requirements in compliance with OSHA for protection of its workers.

The offeror must have (1) a nuclear license to handle radioactive

materials and (2) a controlled substance license to handle androgens.

The offeror must have in-house capabilities for a relatively large

scale synthesis and five full time supporting technical staff

(chemists preferably with a B.S. or M.S. degree) who will devote 100

percent of their time to the project.  No subcontracting will be

permitted.  The above minimum requirements must be met at time of

proposal submission.  The Government estimates the total level of

effort to be approximately 5.25 person years annually.  It is

desirable that the Principal Investigator is an established synthetic

organic chemist and/or medicinal chemist in the synthesis of a

variety of steroidal drugs and optically active, unnatural amino

acids with a Ph.D. degree and will devote a minimum of 25 percent of

her/his time to this project.  All responsible sources may submit a

proposal that will be considered by the agency.  It is anticipated

that one cost-reimbursement incrementally funded type contract will

be awarded as a result of the Request for Proposals (RFP) for a

period of 60 months, beginning August 1, 1996.  The RFP represents a

recompetition of contract N01-HD-1-3137 for the "Maintenance and

Operation of a Synthetic Chemical Facility" being performed by the

Southwest Foundation for Biomedical Research, San Antonio, Texas.


This is not an RFP.  RFP No. NICHD-CD-95-19 was issued on September

14, 1995.  Proposals will be due approximately 60 days thereafter.

Copies of the RFP may be obtained by sending a written request to:

Paul J. Duska

Contracts Management Branch

National Institute of Child Health and Human Development

Executive Building, Suite 7A-07

6100 Executive Boulevard, MSC 7510

Bethesda, MD  20892-7510

FAX:  (301) 402-3676


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