SOLICITATION NOTICE
A -- Pharmaceutical Formulation of Lead Drug Candidates
- Notice Date
- 11/13/2009
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Mental Health, Contracts Management Branch, 6001 Executive Blvd, Rm 8154, MSC 9661, Bethesda, Maryland, 20892-9661
- ZIP Code
- 20892-9661
- Solicitation Number
- HHS-NIH-NIDA(AG)-09-007
- Point of Contact
- Phil Hastings-Tickerhoff, Phone: 3014438402, Teresa A. Baughman, Phone: (301) 443-1193
- E-Mail Address
-
phastings@nida.nih.gov, baughmat@nida.nih.gov
(phastings@nida.nih.gov, baughmat@nida.nih.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- PRESOLICITATION NOTICE RFP No. HHS-NIH-NIDA(AG)-09-007 The National Institute on Aging (NIA), National Institutes of Health (NIH), Department of Health and Human Services (DHHS) intends to recompete a requirement currently being performed by SRI International, Inc. under NIA Contract N01-AG-3-1010. This procurement is a 100% Small Business Set - Aside under NAICS Code 541712. It is anticipated that a single indefinite delivery/indefinite quantity (ID/IQ) type contract will be awarded for a 5-year period of performance beginning on or about April 1, 2010, to provide services in the area of drug development involving the formulation of lead drug candidate(s) for use in intravenous, intramuscular and/or oral administration studies in animals and humans, as well as to formulate compounds for other routes of administration and the preparation of reports and data required for the filing of an IND Application to the FDA in order to receive approval to use the drug in humans. The contract shall provide for: 1) the formulation of the lead drug candidate(s) for use in intravenous, intramuscular and/or oral administration studies in animals and humans, and the capability to formulate compounds for other routes of administration; 2) establishment of the chemical and microbiological purity of the formulated material, the stability of the formulation and, when applicable, the dissolution profiles of the product; 3) packaging and labeling of the formulated product; and, 4) preparation of reports and data required for the filing of an IND Application to the Food and Drug Administration in order to receive approval to use the drug in humans. The desired formulations will involve a wide variety of methods for preparation and testing. These methods may be routine for some formulation(s) and in other instances, development of new formulation methods shall be required. The Contractor shall develop new and/or existing formulations as required. All formulations shall be evaluated for purity and stability by accepted procedures. All formulations produced or procured shall be accounted for, will remain Government property, and shall be delivered and distributed as directed by the COTR (Contracting Officer's Technical Representative). Appropriate laboratory safety controls and procedures shall be followed in carrying out the activities of this project. The Contractor shall provide and operate a material preparation laboratory. The Contractor shall 1) Mix appropriate excipients with drug substance using drug substance provided by the Government and that has been manufactured under Good Manufacturing Practices (GMP) standards and Good Laboratory Practices (GLP); 2) Determine the most suitable dose form (tablet, capsule, oral solution) with desired dissolution characteristics; 3) In the case of parenteral formulations, conduct sterility and pyrogenicity testing; 4) Conduct stability studies to establish the proper storage conditions and shelf life of the prepared pharmaceutical formulations; 5) Prepare formulation labels in accordance with FDA regulations and as approved by the COTR; 6) Prepare and maintain data sheets that include details of sources, purities, and lot numbers of all raw materials used; 7) Deliver the pharmaceutical formulation and data sheets; 8) Prepare additional dose forms as needed. For many drugs this will include both oral and parenteral dose forms; and, 9) Maintain dose units for each pharmaceutical formulation lot manufactured. The Contractor shall be registered with the FDA as a manufacturer of pharmaceutical formulations and maintain such registration throughout the life of the contract. Facilities shall meet FDA standards in accordance with GLP and GMP regulations throughout the life of the contract (see: http://www.fda.gov/CDRH/DEVADVICE/32.html ). The Contractor shall be required to comply with Occupational Safety and Health Act (OSHA), Environmental Protection Agency (EPA) regulations regarding the discharge of water and air pollutants and assure that disposal of all materials meet current EPA regulations (see: http://www.osha.gov/ and http://www.epa.gov/ ). The Contractor shall comply with the Department of Transportation regulations on shipment of toxic and hazardous materials and substances. The following Mandatory Qualification Criteria must be met at the time of initial proposal submission: 1) The laboratory facility must be in compliance with the Food and Drug Administration's (FDA) Good Laboratory Practice Regulations (GLP) as published in the December 22, 1978 Federal Register (Volume 43, No. 247, pp. 59986 60025). GLP Regulations are available on the World Wide Web (WWW) at www.fda.gov/ora/compliance_ref/bimo/glp/87finalrule.htm and GLP Regulations Questions and Answers are available at www.fda.gov/cder/guidance/old004fn.pdf. Compliance is documented in an FDA inspection report. A copy of the two (2) most recent FDA GLP inspection reports must be included in the proposal. If only one (1) report exists, it is acceptable to include only that one (1) report. 2) The Laboratory Facility must be in compliance with the Food and Drug Administration's (FDA) Good Manufacturing Processes (GMP) as published in the http://www.fda.gov/CDRH/DEVADVICE/32.html#introduction and the http://www.fda.gov/cdrh/comp/gmp.html. GMP Regulations Questions and Answers are available at http://www.fda.gov/cdrh/devadvice/16.html and http://www.fda.gov/cdrh/devadvice/ide/faq.shtml. A copy of the two (2) most recent FDA GMP inspection reports must be included in the proposal. If only one (1) report exists, it is acceptable to include only that one (1) report. All responsible sources may submit a proposal which will be considered by the agency. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIMH/HHS-NIH-NIDA(AG)-09-007/listing.html)
- Record
- SN02003466-W 20091115/091113235627-5d8dc4ffc08b2a11d4f13174d4042f07 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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