SOURCES SOUGHT
A -- GMP Synthesis Facility
- Notice Date
- 2/3/2017
- 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 of Child Health and Human Development, Contracts Management Branch, 6710B Rockledge Dr., Suite 1124, MSC7000, Bethesda, Maryland, 20892-7510, United States
- ZIP Code
- 20892-7510
- Solicitation Number
- NIH-NICHD-SBSS-2017-04
- Point of Contact
- Timni Mahase, Phone: 301-435-8867, Cynthia L. Brown, Phone: 301-443-5239
- E-Mail Address
-
timni.mahase@nih.gov, cb25b@nih.gov
(timni.mahase@nih.gov, cb25b@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Purpose of the Announcement: 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. The requirement is assigned a code of 541712 in the North American Industry Classification System (NAICS), and the small business size standard for such requirements is 1000 employees or less. Background: The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) seeks capability statements from interested and qualified potential sources for a GMP Synthesis Facility capable of synthesizing potential anti-fertility agents on a laboratory gram scale to a relatively larger kilogram scale. The kilogram scale chemical agents are manufactured under current Good Manufacturing Practices (cGMP) for comprehensive contraceptive evaluation, including toxicology studies and preclinical safety studies before entering human clinical studies. The facility must be registered with the Food and Drug Administration (FDA) as manufacturer of bulk drug with current FDA Drug Establishment Registration Number. The requirements of this facility include the following: The GMP Synthesis Facility shall be capable of: • Rapidly synthesizing laboratory scale gram quantities of specific chemical compounds required for in vitro and initial in vivo contraceptive investigations. • Synthesize and purify relatively larger quantities of up to 10 kilograms of drug candidates for comprehensive anti-fertility testing by the Government, including toxicology studies preclinical and clinical studies under current cGMP protocol. • Synthesizing chemicals and/or chemical intermediates of up to 10 kg for use in other ongoing chemical, peptide and related contracts and other contract programs. • Stable isotope and radiolabeled synthesis of compounds for pharmacokinetic and metabolism studies. • Peptide synthesis on a laboratory milligram scale to a larger scale of up to 1 kg that may require manufacture under cGMP. The radiolabeled and/or peptide synthesis may be sub-contracted out at cost with Project Officer's prior approval. The successful contractor may be required to collaborate with other investigators in the Contraception Research Branch (CRB) research program in order to make progress toward the development of safe and effective male and female contraceptive drugs. Responses: Capability statements in response to this announcement should be no longer than 15 pages inclusive of all material. Responses will be evaluated on the basis of experience, expertise, and capabilities in the following areas: • The contractor must have capacity and capability for a chemical synthesis and purification of up to 10 kilograms under current Good Manufacturing Practices (cGMP). • The contractor's facility must meet requirements for cGMP as determined by the FDA. • Experienced Principal Investigator and technical staff with multistep synthesis, purification and characterization of small molecules on a laboratory scale and on a large scale of up to 10 kg. • Experience with overseeing cGMP facility performing work with a similar size and scope of this project. • Trained and certified personnel for cGMP manufacture of chemical agents. • Trained quality control (QC) and quality assurance (QA) personnel. • The contractor must have all necessary analytical instrumentation for proper identification and determination of required purity of the compounds produced. • The contractor will have capacity to perform short and long term drug substance stability test as required by the FDA. • The contractor must have previous experience in submitting Drug Master File (DMF) and preparation and submission of the Chemistry, Manufacturing, and Controls (CMC) and related documents for the Investigational New Drug (IND) submission as required by the FDA. 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). Interested Small businesses that believe they possess the capabilities necessary to undertake this project should submit an electronic copy of their capability statement, addressing the areas above. Capability statements must identify organization name, address, point of contact, the business status, size and type of business (e.g., 8(a), HUBZone, etc) pursuant to the applicable NAICS code and DUNS number. Written capability statements should be received by the Contracting Officer/Contract Specialist by no later than 4:00 p.m. (EST) on February 17, 2017. Responses should be no more than 15 pages. These pages exclude resumes. Capability statements should be emailed to: browncx@mail.nih.gov and mahaset@mail.nih.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NICHD/NIH-NICHD-SBSS-2017-04/listing.html)
- Place of Performance
- Address: To be determined., United States
- Record
- SN04390622-W 20170205/170203234309-021199b9486d88f1e5d0e2bf98b30666 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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