SOURCES SOUGHT
R -- Manufacture of Finished Drug Products and Matching Placebos in Capsule Form
- Notice Date
- 10/12/2016
- Notice Type
- Sources Sought
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support/Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SSSA-SBSS-17-011
- Archive Date
- 11/5/2016
- Point of Contact
- Lauren M. Phelps, Phone: 3015942490
- E-Mail Address
-
lauren.phelps@nih.gov
(lauren.phelps@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Request for Information/Sources Sought HHS-NIH-NIDA-SSSA-SBSS-17-011 Manufacture of Finished Drug Products and Matching Placebos in Capsule Form Contracting Office Address: Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, MD 20892, UNITED STATES. Introduction: 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. Background: The NIH Clinical Center Pharmacy Development Section recently discontinued its internal drug capsule manufacturing services and alternative sourcing is now required for manufacture of drug products and matching placebos needed for a clinical protocol at the National Institute of Mental Health (NIMH). NIMH protocol "A controlled double blind study trial of citalopram added to methylphenidate in youth with severe mood dysregulation" currently requires manufacture of drug products and matching placebos. This protocol will test the efficacy of citalopram plus methylphenidate vs. placebo plus methylphenidate in decreasing irritability in youth with severe mood dysregulation. Purpose and Objectives for the Procurement: The purpose of this acquisition is to provide the National Institute of Mental Health with citalopram capsules as well as matched placebo capsules. This requirement constitutes a request for complete drug product manufacturing and control. Project Requirements: The National Institute of Mental Health requires the following: 1.The contractor shall manufacture and provide seven-thousand (7,000) 5mg capsules of Citalopram with seven-thousand (7,000) matching placebos. a.The Contractor must provide reports on the following for this manufacturing process: i.Assay and Impurities/Related Substances Method Qualification of HPLC ready filter compatibility, system suitability, linearity (detection and quantification limits), accuracy and range (bracketing the intended strength), specificity from the diluent, mobile phase and placebo, as well as standard and sample solution stability over 7 days, detection limits and quantification limits. ii.Microbial Enumeration and Tests for Specific Organisms Suitability iii.Homogeneity Analysis on blend samples iv.Finished Product Release Testing on Appearance, Identification, Assay and Degradants, Capsule Closure, Aerobic Microbial Enumeration (USP <61>), Yeast and Mold Enumeration (USP <61>), and Testing for Specified Microorganisms (USP <62>). v.Stability Assessment to ensure stability in the following storage conditions: Storage condition must include the following combination: 25°C/60% RH. Storage duration will include the following number of months: 3, 6, 12, 18, 24, and 36. 2.Capsule manufacturing will include preparation of complete formulation development, manufacturing records according to customer specifications, milling of tablets for the actives, blending tablet powder with other excipients as per manufacturing records, filling of the powder into capsules, capsule weight monitoring, cleaning the room, and inspection of capsules. The contractor shall be responsible for procuring Citalopram for the capsule manufacturing process. 3.All capsules shall be bulk packaged in High-Density Polyethylene (HDPE) containers. 4.All drug and placebo capsule manufacturing must be performed in a facility licensed by the US Food and Drug Administration as a Good Manufacturing Product (GMP) facility. 5.The Contractor shall ensure that all workers wear protective respirators and clothing if/as applicable for the type of compound being manufactured. Government Furnished Property The Government shall provide the successful offeror with the formulas for the necessary drug products. Additionally, the Government shall provide the capsules to be used for the drug product and matching placebo manufacture. The Government will arrange for the capsules to be shipped to the Contractor. Anticipated Contract Type: A firm fixed price purchase order within the Simplified Acquisition threshold is anticipated. Period of Performance Delivery of the manufactured drug products and associated documentation shall be made within twelve (12) weeks following contractor receipt of the drug formulas and capsules provided by the Government. Contractor delivery of the manufactured drug products and associated documentation shall be made on a FOB Destination basis and any cost associated with this must be included in any quotation submitted. Place of Performance/ Delivery Requirements Drug products and matching placebos shall be manufactured at the contractor site then delivered to the Department of Pharmacy, IDMRS located at 10 Center Drive, Room 1C230, Bethesda, MD 20892. Capability Statement: Contractors that believe they possess the ability to provide the required services should submit documentation of their ability to meet each of the project requirements to the Contract Specialist. The capability statement should include 1) the total number of employees, 2) documentation of ability to provide the required support, 3) any contractor GSA Schedule contracts by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Contractors must also provide their Company Name, DUNS number, Physical Address, and Point of Contact Information. Interested organizations are required to identify their type of business, applicable North American Industry Classification System Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. All capability statements sent in response to this Sources Sought Notice must be submitted to Lauren Phelps, Contract Specialist, via email at lauren.phelps@nih.gov before the closing date and time of this announcement. All responses must be received by the specified due date and time in order to be considered. Note: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. No proprietary, classified, confidential, or sensitive information should be included in your 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 review of the responses received, pre-solicitation and solicitation notices may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. The solicitation release date is pending. The Government anticipates negotiation of a firm fixed price purchase order.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-2/HHS-NIH-NIDA-SSSA-SBSS-17-011/listing.html)
- Place of Performance
- Address: Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN04303032-W 20161014/161012235311-57c499071a1c36cfa2ff5a3becd7d45d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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