DEVELOPMENT AND MANUFACTURE OF DOSAGE FORMS OF COMPOUNDS WITHPOTENTIAL FOR TREATMENT OF INFECTIOUS DISEASES



NIH GUIDE, Volume 22, Number 41, November 12, 1993



RFP AVAILABLE:  NIH-NIAID-DAIDS-95-03



P.T. 34



Keywords:

  Infectious Diseases/Agents 

  Dosage Forms+ 



National Institute of Allergy and Infectious Diseases



The Developmental Therapeutics Branch, Basic Research and Development

Program, Division of AIDS of the National Institute of Allergy and

Infectious Diseases (NIAID) has a requirement for the development and

manufacture of dosage forms of potential therapeutic agents that are

intended for evaluation in Phase I and Phase II clinical protocols.

The contractor will be required to:  determine suitable formulations

for therapeutic agents, evaluate new formulation compositions and

technologies, manufacture dosage formulations, evaluate bulk drug

substances using appropriate analytical assays, and conduct quality

control testing of manufactured dosage forms.  The Request for

Proposals (RFP) contains two mandatory qualification criteria:  (1)

pharmaceutical companies are excluded from participating as a prime

contractor or subcontractor and (2) at the time of the Best and Final

Offers, the Offeror must be capable of manufacturing pharmaceutical

materials in compliance with current Good Manufacturing Practice

(GMP) regulations (21 CFR 210-211).  This announcement is for the

recompetition of a current contract the ended October 25, 1993.  RFP

NIH-NIAID-DAIDS-95-03 was issued November 1, 1993, and proposals will

be due by COB February 15, 1994.  It is anticipated that one level-

of-effort type cost reimbursement contract will be awarded and the

period of performance for this contract will be five years.



A short-form version of the RFP will be available, for informational

purposes, which includes the background information, the full

Statement of Work, Evaluation Criteria, and the Reporting

Requirements.  There is sufficient information in this document to

enable prospective offerors to determine if they have the

expertise/capability to meet the Government's requirements.  A full-

text version is also available, which includes all the necessary

information, business forms, etc., to submit a proposal.  There are a

limited number of full-text versions available.  Therefore, request

the short-form RFP first, then the full-text version only if you

intend to submit a proposal.  All requests must be in writing.

Specify if you are requesting the short-version or full-text version

of the RFP (if no distinction is made, the short-form version will be

sent).  Fax responses are acceptable, but it is preferred that

requests be submitted in writing with two self-addressed mailing

labels attached to ensure proper delivery.  All proposals from

responsible sources will be considered by the NIAID.  This

advertisement does not commit the Government to award a contract.



INQUIRIES



Requests for the RFP are to be directed in writing to:



Mr. Ross Kelley

Contract Management Branch

National Institute of Allergy and Infectious Diseases

Solar Building, Room 3C07

6003 Executive Boulevard

Bethesda, MD  20892

Telephone:  (301) 496-2509

FAX:  (301) 402-0972



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