MODIFICATION
A -- Drug Manufacturing and Formulation Program (DMFP) - Solicitation 1
- Notice Date
- 7/14/2017
- Notice Type
- Modification/Amendment
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- 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
- NIH-NINDS-17-05
- Archive Date
- 9/26/2017
- Point of Contact
- Donna Morris, Phone: (301) 496-1813, Kirkland L. Davis, Phone: (301) 496-1813
- E-Mail Address
-
donna.morris@nih.gov, kd17c@nih.gov
(donna.morris@nih.gov, kd17c@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- RFP No. NIH-NINDS-17-05 Attachment No. 12(a-f) Business Proposal Budget Templates RFP No. NIH-NINDS-17-05 Attachment No. 7(a-e) Technical Proposal Budget Templates RFP No. NIH-NINDS-17-05 including Attachments (other than excel attachments 7(a-e) and 12(a-f). The purpose of this solicitation is to re-open and solicit new offers under the NIH's Blueprint Neurotherapeutics Network (BPN) contract program for manufacturing and formulation services of dosage forms of small molecule drug candidates to be used in preclinical and clinical studies for neurological disease disorders. In January 2015, the NINDS made two 10-year IDIQ contract awards to Albany Molecular Research Inc., Albany, New York and MRIGlobal, Kansas City, Missouri under its Drug Manufacturing and Formulation Program. These are the only two organizations currently under the DMFP contract program. NINDS has a need to increase the competition pool under this program and the plan to re-issue the exact RFP requirements originally advertised and competed back in 2014. This requirement was originally advertised for a 10-year order period, with a maximum of $50.9 million and a minimum of $25,000. These minimums and maximums are still applicable to any new award(s). The order period under any new award(s) will be from the time of the award through the end of the program's current ordering period, January 14, 2025. The Government anticipates awarding multiple Indefinite Delivery/Indefinite Quantity (IDIQ) type contracts under this solicitation. The NIH established the Blueprint Neurotherapeutics Network (BPN) to bridge the gap in drug development between academic and industry research (http://neuroscienceblueprint.nih.gov/dpdrugs/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. 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. 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 in the Statement of Work 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 approved 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. OFFERORS ARE RESPONSIBLE FOR ROUTINELY CHECKING THE FEDBIZOPPS WEBSITE FOR ANY POSSIBLE SOLICITATION AMENDMENTS THAT MAY BE ISSUED. NO INDIVIDUAL NOTIFICATION OF ANY AMENDMENTS WILL BE PROVIDED. All responsible sources may submit a proposal, which shall be considered by the agency.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-01/NIH-NINDS-17-05/listing.html)
- Record
- SN04580095-W 20170716/170714234854-f72b4742755446e6ab7ba6db925195f2 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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