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All Federal Contract Awards
Delivery Order HHSN271201500005I-HHSN27100004
Award Date
4/22/15
Potential Completion Date
1/14/25
Potential Value
$51K
Overview
Contacts
Activity
3
Transactions
3
Subawards
Opportunity Stack
Similar Awards
Funding Federal Agency
National Institute of Neurological Disorders and Stroke
Contracting Federal Agency
National Institute on Drug Abuse
Awardee
Curia Global Inc. ELCNZCS8GEA3
Ultimate Awardee
Not listed
NAICS Category
325412 - Pharmaceutical Preparation Manufacturing
PSC Category
AZ13 - R&D- Other Research And Development (Advanced Development)
Set-Aside Type
No Set-Aside Used
Federal Contract Vehicle
Drug Manufacturing and Formulation Program
Extent Competed
Full and Open Competition
Major Defense Program
Not listed
Pricing Type
Cost Plus Fixed Fee
Place of Performance
Albany, NY 12212, USA
Solicitation Procedures
Multiple Award, Fair Opportunity
Number Of Offers Received
2
Legislative Mandate
Not listed
National Interest Action
Not listed
Research Type
Not listed
Primary Consortia Member
Not listed
Drug Manufacturing and Formulation Program (DMFP)
Master IDIQ
HHSN271201500005I
Indefinite Delivery Contract
HHSN271201500005I-HHSN27100004
Delivery Order
Update #1
Update #2
Update #3
Update #4
DMFP - TASK ORDER NO. 4 WAGNER BPN-15606
Posted 4/24/15
5
1
Name
Description
Solicitation Number
FederalAgency
Type
PostedDate
Drug Manufacturing and Formulation Program (DMFP)
Added: Apr 17, 2014 4:44 pm THIS IS NOT A REQUEST FOR PROPOSALS (RFP). THIS IS A PRE-SOLICITATION ANNOUNCEMENT ONLY. A REQUEST FOR PROPOSALS (RFP) NO. NIH-NINDS-14-02, ENTITLED: "DRUG MANUFACTURING AND FORMULATION PROGRAM (DMFP)," WILL BE ISSUED VIA FEDBIZOPPS ON OR ABOUT MAY 1, 2014.The NIH established the Blueprint Neurotherapeutics Network (BPN) to bridge the gap in drug development between basic researchers and biopharmaceutical companies (http://neuroscienceblueprint.nih.gov/bpdrugs/index.htm).The Network offers neuroscience researchers a "virtual pharma" to develop promising hit compounds from chemical optimization tough Phase I human clinical testing. The BPN supports, tough grants and contracts, every step of the drug development process from validated hits to Phase I human clinical trials.This proposed contract initiative, under the auspices of the NIH, National Institute of Neurological Disorders and Stroke (NINDS), and as part of the BPN, will support the development and manufacture of dosage forms (e.g., including and not limited to parenteral, oral solutions, tablets, capsules, and ocular delivery systems) of small molecule drug candidates suitable for administration in preclinical efficacy studies, Investigational new drug (IND) enabling studies, and clinical trials. Work under the proposed contract will include process development and preparation of active pharmaceutical ingredients (API), pre-formulation and formulation studies, physical and chemical characterizations, analytical method development and validation, stability studies, drug product manufacturing, packaging, storage, quality control, regulatory documentation, and distribution of the drug products. All work will be conducted in accordance with Current Good Manufacturing Practices regulations (cGMPs) and, as appropriate, Good Laboratory Practice (GLP) regulations.The NINDS anticipates awarding multiple Indefinite Delivery/Indefinite Quantity (ID/IQ) type contracts that, together, will constitute the DMFP.The ultimate goal of the Blueprint program and the individual manufacturing projects is to bring new drugs to market. To this end, the NIH has received approval for a Determination of Exceptional Circumstances (DEC) and has obtained authorized deviations from the Federal Acquisition Regulations Clause at 52.227-11, "Patent Rights," and 52.227-14, "Rights in Data" that will be applicable to any resultant contract awarded under this program. Prospective offerors are advised that agreement to the terms of these FAR clause deviations will be a condition for contract award. Deviations from the standard FAR Clauses mentioned above will enable the BPN program compound Contributors to retain control of the intellectual property for compounds created tough the DMFP.Request for Proposals (RFP) No. NIH-NINDS-14-02 will be available at the FedBizOpps website on or about May, 1, 2014. 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.Sincerely,Laurie LeonardContracting OfficerNINDS R&D Contracts Management BranchNational Institute on Drug Abuse, NIH
NIH-NINDS-14-02
Department of Health and Human Services National Institutes of Health
Award Notice 1/1
4/17/14, 4:44 PM
5
1
Mod #
Description
ReasonForModification
Federal Obligation
Date
P00002
WAGNER AMRI
Funding Only Action
($43k)
6/26/20
1
DMFP - TASK ORDER NO. 4 WAGNER BPN-15606
Other Administrative Action
$0
3/13/17
Not listed
DMFP - TASK ORDER NO. 4 WAGNER BPN-15606
Not listed
$94.7k
4/24/15