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GMP Synthesis of Bulk Drug Substances

Solicitation Number: N01DA-15-8915
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Institute on Drug Abuse
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N01DA-15-8915
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Solicitation
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Added: May 21, 2014 3:10 pm Modified: May 21, 2014 3:12 pmTrack Changes
The National Institute on Drug Abuse (NIDA) intends to solicit proposals from offerors having the capability to manufacture bulk drug substances under Good Manufacturing Practices (GMP), using the regulations and guidelines listed in the Code of Federal Regulations (CFR), Food and Drugs, 21, Part 211, "Current Good Manufacturing Practice for Finished Pharmaceuticals." These bulk drug substances will be used to support NIDA preclinical safety testing and subsequent safety and efficacy clinical trials.

Offerors must demonstrate the ability to manufacture bulk drug substances under both GMP following relevant Food and Drug Administration (FDA) guidance and regulations (e.g. Code of Federal Regulations (CFR) Title 21) and non-GMP. Offerors must also indicate experience in producing GMP and non-GMP drug substances in batch sizes of at least one kilogram or larger, and appropriately store GMP and non-GMP materials on site. Offerors must have onsite access to state-of-the-art equipment for analytical testing (high-performance liquid chromatography (HPLC), gas chromatography-mass spectrometry (GC-MS), liquid chromatography-mass spectrometry (LC-MS), isotope ratio (IR), circular dichroism (CD) and nuclear magnetic resonance (NMR)). Additionally, offerors must show experience in preparing reports acceptable in format and substance for adaptation into a Chemistry, Manufacturing and Control (CMC) section for each drug substance for submission to the FDA in support of Investigational New Drug (IND) and New Drug Application (NDA) applications.

Due to the nature of the bulk drug substances being used to support NIDA preclinical safety testing and subsequent safety and efficacy clinical trials, it is mandatory that offerors' facility is in good standing with the FDA. In addition, to handle substances or starting materials under the Controlled Substance Act of 1970, it is mandatory that offerors possess Drug Enforcement Administration (DEA) Research and Manufacturing Registrations for Schedules II to V controlled substances and demonstrate the capability to obtain DEA Research and Manufacturing Registrations for Schedule I controlled substances.

NIDA anticipates the award of a single, five-year, indefinite delivery, indefinite quantity (IDIQ) task order contract. NIDA may award either cost reimbursement and/or fixed price task orders under this contract. NIDA anticipates that at least one task order will be awarded with the initial contract award.

RFP No. N01DA-15-8915 will be available electronically on or about June 5, 2014. You will be able to access the RFP through FedBizOpps (URL: http://www.fedbizopps.gov or through the NIDA website at the following URL: http://www.drugabuse.gov/funding/funding-opportunities/nida-requests-contract-proposals-rfps). All information required for the submission of an offer will be contained in or accessible through the RFP package. Responses to the RFP will be due on or about 45 days after release of the RFP. NIDA will consider proposals submitted by any responsible offeror.

Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons may identify to the Contracting Officer their interest and capability to satisfy the Government's requirement with a commercial item within 15 days of this notice.

This advertisement does not commit the Government to award a contract.
Added: Jul 15, 2014 3:56 pm
Amendment No. 01 to RFP No. N01DA-15-8915

Purpose: To respond to formal questions submitted in response to the solicitation. 
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Solicitation 1

Type:
Solicitation
Posted Date:
June 27, 2014
Description: RFP for N01DA-15-8915

Amendment 1

Type:
Mod/Amendment
Posted Date:
July 15, 2014
Description: Amendment No. 01 to NIDA RFP No. N01DA-15-8915
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6001 Executive Boulevard
Room 4211 - MSC 9559
Bethesda, Maryland 20892
United States
:
Andrew Hotaling,
Contract Specialist
Phone: 301.443.6677
Fax: 301.443.7595
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Kenneth E Goodling,
Contracting Officer
Phone: (301)443-6677
Fax: (301)443-7595