SOURCES SOUGHT
A -- Pharmaceutical Formulation of Lead Drug Candidates
- Notice Date
- 7/8/2009
- Notice Type
- Sources Sought
- 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)-SBSS-09-007
- Point of Contact
- Drake Russell, Phone: 301-443-0212, Teresa A. Baughman, Phone: (301) 443-1193
- E-Mail Address
-
russeldr@mail.nih.gov, baughmat@nida.nih.gov
(russeldr@mail.nih.gov, baughmat@nida.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. BACKGROUND: The National Institute on Aging (NIA) Intramural Research Program (IRP) has a program designed for the rapid development of drug candidates up to the filing of an Investigational New Drug (IND) Application to the Food and Drug Administration (FDA) in order to receive approval to use the drug in humans and the first-time administration to humans. This contract will be for the following, 1) 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; 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. This work was previously done under contract number N01-AG-3-1010 ("New Therapeutic Targets for the Treatment of Neurodegenerative Disease, Diabetes Mellitus, Congestive Heart Failure, Oncologic and Immunologic Disease - Pharmaceutical Formulation of Drugs"). PURPOSE AND OBJECTIVES: The contract provides 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 the capability 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. PROJECT REQUIREMENTS: All work shall be done as directed by a Work Assignment (WA). 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. Desirable dissolution characteristics will be specified by the Project Officer; 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 and maintain data sheets that include details of sources, purities, and lot numbers of all raw materials used; 6) Deliver the pharmaceutical formulation and data sheets; 7) Prepare additional dose forms as needed. For many drugs this will include both oral and parenteral dose forms; and, 8) 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 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 substances. The desired formulations will involve a wide variety of methods for preparation and testing. These methods may be routine for some formulation and in other instances, development of new formulation shall be required. The Contractor shall develop new and/or existing formulations 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 Project Officer. Appropriate laboratory safety controls and procedures shall be followed in carrying out the activities of this project. REPORTS AND DELIVERABLES: The following reports will be required: Monthly Technical Progress Report, Annual Technical Progress Report, and Final Report. ANTICIPATED PERIOD OF PERFORMANCE: The anticipated period of performance is one (1) year (04/01/10 through 03/31/11), with four (4) 12-month option periods. OTHER IMPORTANT CONSIDERATIONS: The North American Industry Classification System (NAICS) Code 541712 with a size standard of 500 employees is being contemplated. 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. CAPABILITY STATEMENT/INFORMATION SOUGHT: Respondents to this notice must provide, as part of their responses, a capability statement to include the following: (1) information regarding the respondents' (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and, (e) examples of prior completed Government contracts, references, and other related information; (2) respondents' DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc.) pursuant to the applicable NAICS code; and, (4) any other information that may be helpful in developing or finalizing the OPDIV's acquisition requirement. INFORMATION SUBMISSION INSTRUCTIONS: Respondents should provide responses accordingly: (1) submit information both electronically and by mail. No telephone or facsimile responses will be accepted; (2) format capability statements using Microsoft Word or Adobe PDF including attachments, resumes, charts, etc. Use single space, 12 font minimum and 8 ½ x 11 size paper; (3) organize material in such a manner that clearly identifies and address capability requirements and provide an executive summary; (4) capability statement should not exceed ten (10) single sided pages including references; (5) respondents must send two original copies via mail and one electronic copy via email; (6) responses should be received no later than July 22, 2009 at 2:00 PM Local Time; (7) include respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses; and (8) send responses to this notice via email to russelldr@mail.nih.gov. The original statements mailed using the U.S. Postal Service should be sent to ATTN: Drake Russell, National Institutes of Health, Office of Acquisitions - NIDA Neuroscience COAC, NIA R&D Contracts Management Section, 6001 Executive Boulevard, Room 8154, MSC 9661, Bethesda, MD 20892-9661. If using a courier service such as the UPS, Federal Express, etc., change the City, State and Zip Code to Rockville, MD 20852. (Please be aware that the U.S. Postal Service's "Express Mail" DOES NOT deliver to the Rockville, Maryland address.) DISCLAIMER AND IMPORTANT NOTES. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. CONFIDENTIALITY. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIMH/HHS-NIH-NIDA(AG)-SBSS-09-007/listing.html)
- Record
- SN01868685-W 20090710/090709000204-7eb851a255775d29fc588aab21564acc (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |