SOURCES SOUGHT
A -- Reagent Generation for Bioanalytical Method Development on Biologics
- Notice Date
- 5/2/2017
- 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 on Drug Abuse, 6001 Executive Boulevard, Room 4211, MSC 9559, Bethesda, Maryland, 20892-9559, United States
- ZIP Code
- 20892-9559
- Solicitation Number
- HHS-NIH-NCATS-SBSS-17-001
- Archive Date
- 6/8/2017
- Point of Contact
- Stuart G. Kern, Phone: 3014023334, Jeffrey Schmidt, Phone: (301) 402-1488
- E-Mail Address
-
stuart.kern@nih.gov, schmidtjr@mail.nih.gov
(stuart.kern@nih.gov, schmidtjr@mail.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. Please note that to qualify as an eligible small business for purposes of a small business set-aside, at least 50% of the cost of contract performance incurred for personnel must be expended for employees of the small business awardee (see FAR 52.219-14 Limitations on Subcontracting). Background & Purpose Researchers nationwide and across the globe face common barriers in translational research that can delay the development of new interventions for patients in need. The National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) studies translation on a system-wide level as a scientific and operational problem to accelerate the development of treatments and preventive strategies for a wide range of diseases. Within NCATS, the Division of Pre-Clinical Innovation (DPI) plans, conducts and uses both internal and contract resources to advance collaborative research projects across the pre-clinical phases of the translational science spectrum. Contract research organizations (CROs) provide manufacturing, pharmacology, toxicology, regulatory and clinical operations services to DPI to assist with probe and assay development, lead selection and optimization, and Investigational New Drug (IND)-directed studies. The objectives of the Translational Research in Pharmacokinetics and Drug Metabolism (TRPDM) Program are to study absorption, distribution, metabolism and elimination (ADME) properties of novel therapeutics and to clarify the relationship between drug concentrations and efficacy of toxicity in vivo. In order to determine Pharmacokinetics (PK) of therapeutic biologics, quantitative bioanalytical assays for biologics and anti-drug antibodies are required. These assays will be used to support preclinical and clinical studies conducted under the Therapeutics for Rare and Neglected Diseases (TRND) Program. Note: no human subject testing is to be performed under this contract. Project Requirements Written capability statements should demonstrate your organization's ability and related experience in the following area: Reagent Generation (a)Develop polyclonal anti-drug antibodies (ideally with active epitope neutralizing activity). (b)Develop monoclonal anti-drug antibodies (ideally at least one with active epitope neutralizing activity). (c)Characterize the specificity of the antibodies (with respect to their reactivity towards to drug specific active epitope(s)). (d)Produce purified and modified antibod(y/ies) suitable for assay development. (e)Conduct work in accordance with site-specific Standard Operating Procedures (SOP). (f)Maintain batch records and detailed information on procedures used to generate and characterize the reagents. Additional Information Specify whether your organization uses any proprietary technology. If so, clarify whether NCATS and NCATS Collaborators will have freedom to use the technology at a third party facility in case the project is later transferred to a third party. In addition, your organization's capability statement should: (1)Indicate how many staff members (e.g. Principal Investigators and Technical Scientists) the small business would be able to dedicate to the program, and which of those would be available in-house; (2)Identify which requirements would be performed in-house versus those that would be performed outside your organization; and (3)Describe your organization's ability to rapidly scale staff capacity up or down to support the anticipated workload. Anticipated Period of Performance The Government anticipates making multiple Indefinite Delivery/Indefinite Quantity (ID/IQ) type contract awards under the future solicitation-each with a five year ordering period. The Government anticipates awards will be made in the third quarter of FY2018. Other Important Considerations Data and documentation generated under this program could be used for regulatory filing purposes. When required, data and documents must be prepared in a form acceptable to the Food and Drug Administration (FDA) for inclusion in a Drug Master File (DMF), IND application, or New Drug Application (NDA). To enable Collaborators to retain control of the intellectual property for compounds created through the TRCMC program, the Government has sought a Declaration of Exceptional Circumstances (DEC) to the Federal Acquisition Regulations (FAR) for this program. Required Information All capability statements must provide the following: (1) DUNS number; (2) organization name; (3) organization address; (4) point of contact; (5) point of contact title, address, telephone, and email address; and (6) size and type of business (e.g., 8(a), HUBZone, etc.) pursuant the applicable NAICS code. Submission Instructions and Due Date Written capability statements must be SUBMITTED NO LATER THAN Wednesday, May 24, 2017 to the contracting office listed below, Attn: Stuart Kern. Electronic capability statements will be accepted by the primary point of contact. 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/NIDA-01/HHS-NIH-NCATS-SBSS-17-001/listing.html)
- Record
- SN04493629-W 20170504/170502235834-66d5836817932f72363ae4d05c889a68 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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