MODIFICATION
R -- Aseptic Manufacture, Filling and Sterility Testing of Mangofodipir Trisodium Injection
- Notice Date
- 8/20/2015
- Notice Type
- Modification/Amendment
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- 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
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SSSA-SBSS-15-790
- Archive Date
- 9/9/2015
- 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
- Aseptic Manufacture, Filling and Sterility Testing of Mangofodipir Trisodium Injection Small Business Sources Sought Notice 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. Purpose and Objectives for the Procurement: The purpose of this requirement is acquisition of professional scientific services to aseptically manufacture and fill mangofodipir trisodium injections as well as performance of sterility testing of the injections. This requirement is in support of the National Institute of Neurological Disorders and Stroke's Translational Neuroradiology Unity. Project Requirements: The NINDS Translational Neuroradiology Unit requires a Contractor to perform the following services: 1. The Contractor shall compound, filter, and aspectically fill 300 mangofodipir trisodium injections into vials for clinical use. 2. Prior to creating the 300 vial batch for clinical use, the Contractor shall prepare a trial batch of mangofodipir trisodium vials for Government inspection. 3. The Contractor shall write a test method for sterility testing using a provided method suitability report. The clinical batch shall be release tested for sterility and a CoA for sterility shall be issued. pH testing shall also be carried out. Anticipated Period of Performance: The Contractor shall deliver manufacturer product within four (4) weeks after receipt of order and shall be delivered between the hours of 8:00 AM to 5:00 PM, Bethesda, MD local prevailing time, Monday through Friday. A program office point of contact shall be provided at time of award and this individual should be notified by phone or email at least three days in advance of the anticipated delivery date. Anticipated Place of Performance: Efforts shall be performed at the Contractor site. Government Furnished Property: The Government shall provided all excipients and active and container closure components necessary for performance of this requirement as well as a method suitability report for sterility testing purposes. Anticipated Contract Type: A firm fixed price purchase order is anticipated. Invoicing shall be on a NET30 basis. Capability Statement: Contractors that believe they possess the ability to provide the required equipment should submit documentation of their ability to meet each of the project requirements to the Contract Specialist. Contractors must 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 electronically (via email) to Lauren Phelps, Contract Specialist, at Lauren.Phelps@nih.gov in MS Word format by or before the closing date 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 intends to negotiate a fixed-price purchase order.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-2/HHS-NIH-NIDA-SSSA-SBSS-15-790/listing.html)
- Place of Performance
- Address: Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03847741-W 20150822/150820235732-b07c525c6581c90b12932de8eabdd859 (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 |