SOURCES SOUGHT
A -- Drug Manufacturing and Formulation Program (DMFP) - Requirement Description
- Notice Date
- 7/18/2013
- Notice Type
- Sources Sought
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Neurological Disorders and Stroke, 6001 Executive Boulevard, Neuroscience Center, Suite 3287, MSC 9531, Bethesda, Maryland, 20892-9531
- ZIP Code
- 20892-9531
- Solicitation Number
- NINDS-SB-SS-13-01
- Point of Contact
- Laurie A Leonard, Phone: 301 496-1813, Annette Carter, Phone: (301) 496-1813
- E-Mail Address
-
ll44s@nih.gov, cartera@nida.nih.gov
(ll44s@nih.gov, cartera@nida.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Attachment to Small Business Sources Sought Notice NINDS-SB-SS-13-01 - Description of Requirements DRUG MANUFACTURING AND FORMULATION PROGRAM (DMFP) SMALL BUSINESS SOURCES SOUGHT - NINDS-SB-SS-13-01 PURPOSE: The NIH established the Blueprint Neurotherapeutics Network (BPN) to bridge the gap in drug development between academic and industry research (http://neuroscienceblueprint.nih.gov/bpdrugs/index.htm). The BPN supports, through grants and contracts, every step of the drug development process from validated hits through Phase I clinical trials. The Drug Manufacturing and Formulation Program (DMFP), a component of the BPN, will conduct the development and manufacture of dosage forms of small molecule drug candidates suitable for administration in preclinical efficacy studies, Investigational New Drug (IND) enabling studies, and clinical trials. The National Institute of Neurological Disorders and Stroke (NINDS) anticipates awarding multiple Indefinite Delivery/Indefinite Quantity (ID/IQ) contracts that, together, will constitute the DMFP. Contractors will conduct process development and preparation of active pharmaceutical ingredients (API), pre-formulation and formulation studies, analytical method development and validation, stability studies, drug product manufacturing, packaging, storage, and distribution of the drug products. The work will be conducted in accordance with Current Good Manufacturing Practices regulations (cGMPs) and as appropriate Good Laboratory Practice (GLP) regulations. Data and documentation will be prepared for example CMC regulatory documents 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). Demonstrate the capability to perform the required work in-house, rather than through subcontractors. THIS ANNOUNCEMENT IS NOT A REQUEST FOR PROPOSALS, and if your business concern is NOT a small business, there is no need to respond to this announcement. Once a determination is made regarding the suitability of this future requirement for a small business set-aside or an open competition to include both large and small business, a separate Pre-Solicitation Announcement will be issued in advance of the release of a Request for Proposals. The applicable North American Industry Classification System (NAICS) code for this requirement is 325412. Therefore, the small business size standard for this announcement is 750 or fewer employees. Please note that in order to qualify as an eligible small business for purposes of a small business set-aside, at least 50% of the direct labor cost must be in -house. Specifically, FAR 52-219-14 - Limitations on Subcontracting states that at least 50 percent of the cost of contract performance incurred for personnel shall be expended for employees of the concern. Submitted Capability Statements must address how the business meets the applicable size standard designated for this project. BACKGROUND: The design of the DMFP is to provide neuroscientists with drug manufacture and drug formulation services for the development of candidate molecules suitable for administration in preclinical efficacy studies, Investigational New Drug enabling studies, and clinical trials. The work of the Contractor will be divided into Performance Activities. In general, each candidate compound brought to the Contractor will include any or all of the following activities listed on the Attachment to this notice. The ultimate goal of the Blueprint program and of individual manufacturing projects is to bring new drugs to market. To this end, the NIH has sought a Declaration of Exceptional Circumstances (DEC) to the Federal Acquisition Regulations (FAR) for this contract. The DEC enables the Contributors to retain control of the intellectual property for compounds created through the DMFP. INFORMATION REQUESTED: Your response should demonstrate your ability and related experience in a requirement-specific Capability Statement to: 1) API Scale Up and Manufacture a) Chemistry Technology Transfer b) Process Development c) Chemical Synthesis d) Analytical Method Development e) Package, Label, Storage and Distribution f) Non-standard/Exploratory Studies 2) Formulation and Dosage Form Manufacture a) Preformulation Studies: API b) Preformulation Studies: Excipients c) Formulation d) Manufacture e) Stability Studies f) Package, Label, Storage and Distribution 3) Validation This Capability Statement should indicate how many staff members that the small business would be able to dedicate to such a contract, and which of those would be available in-house. The requirements that would be performed in-house versus those that would be performed outside your organization should be clearly identified. The ability to rapidly scale staff capacity up or down in order to support the anticipated workload should also be addressed. Please submit your response to the attention of Laurie Leonard, Contracting Officer at the address following email address: leonardl@nida.nih.gov (please format for printing) by 4:00 PM Local Time on August 5, 2013. You are encouraged to limit your response to fewer than 15 pages and your response must specifically address each of the requirements specific information requested items stated above. Generic marketing brochures will not be considered further. Electronic responses will only be accepted This Announcement is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Government. The Government does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted or the Government's use of such information. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the Government's evaluation of the information received. However, should such a requirement materialize, no basis for claims against the Government shall arise as a result of a response to this announcement or the Government's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. Responses will be held in a confidential manner. Any proprietary information should be so marked. All respondents are asked to indicate the type and size of your business organization, e.g. Small Business, Veteran-Owned Small Business, Service-Disabled Veteran-Owned Small Business, HUBZone Small Business, Small Disadvantaged Business, Women-Owned Business, or 8(a). Laurie Leonard, Contracting Officer, National Institutes of Health, NINDS R&D CMB, 6001 Executive Blvd., Suite 3287, Bethesda, MD 20892-9531 or via courier to Rockville, MD 20852.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NINDS/NINDS-SB-SS-13-01/listing.html)
- Record
- SN03120844-W 20130720/130719001254-e55249e0ea88af62a73aaa26a7c251a8 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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