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This Government Contract opportunity was posted on August 23, 2012. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

Regulatory Filing Support for the Development of Medications

Awarded
N01DA-12-8902Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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NAICS: 541990
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AI Contract Overview

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The National Institute on Drug Abuse is soliciting proposals under RFP N01DA-12-8902 for regulatory filing support to assist in the development of medications. This procurement is a 100 percent set-aside for Service-Disabled Veteran-Owned Small Businesses under NAICS code 541990. The selected contractor will be responsible for preparing, compiling, indexing, and filing various regulatory documents, including Initial Investigational New Drug applications, New Drug Application submissions, annual reports, and protocol amendments. All work must adhere to FDA regulations, International Conference on Harmonization guidances, and Good Clinical Practice guidelines. The government intends to award a single cost-reimbursement indefinite delivery, indefinite quantity contract with options for additional work and at least one anticipated task order. Amendment 1 to the RFP was issued to update the title, revise the Statement of Work, and clarify submission methods to the FDA. Interested parties must follow the guidelines provided in the RFP package, and the government has specified that it is not utilizing commercial item acquisition policies for this specific procurement.

General Info

Agency

N/A

Contract Value

$483,563.45

NAICS

541990 - All Other Professional, Scientific, and Technical Services

Place of Performance

MD, USA

Set-Aside

NONE

Award Issued Date

Documents

0

No documents available

Documents will appear here when they are available.

AI Contract Breakdown

Uniform Contract Format

No documents to break down

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Timeline

1 update
PhaseAwarded
Posted

Combined Synopsis

Notice updated

The notice title changed. The notice description changed.

Awarded

Contract was awarded

Submission Closed

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Organization & Contact Information

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AgencyN/A
Contacts2 people available
OfficeN/A
Organization / Agency
N/A
Office AddressN/A
Contacts
Kara AndersonContract Specialist
Brian H O'LaughlinContracting Officer

Full Description

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PURPOSES OF AMENDMENT 1 to RFP N01DA-12-8902: To edit the title of this RFP, revise the Statement of Work (SOW), and answer questions regarding this RFP (which includes clarifying methods of submissions to the U.S. Food and Drug Administration (FDA)). See attached amendment. The RFP for N01DA-12-8902 has been released. See attached. Synopsis: This Procurement will be a 100% Service-Disabled Veteran-Owned Small Business Set-Aside. The National Institute on Drug Abuse (NIDA) intends to solicit proposals from qualified Service-Disabled Veteran-Owned Small Businesses (NAICS Code 541990: Size standard is up to $14,000,000, effective March 12, 2012). NIDA intends to solicit proposals to provide regulatory support for the development and filing of regulatory submissions for NIDA. This includes, but is not limited to, the preparing, compiling, indexing, and filing of Initial Investigational New Drug (IND) Applications, New Drug Application (NDA) submissions, Annual Reports, Protocol Amendments, and Information Amendments, as needed for ongoing INDs held by NIDA, and Ad Hoc regulatory documents for submission and registration with regulatory agencies. All submissions are to be developed in accordance with the Food and Drug Administration (FDA) regulations, International Conference on Harmonization (ICH) guidances and Good Clinical Practice (GCP) guidelines. NIDA anticipates the award of a single cost-reimbursement indefinite delivery, indefinite quantity type contract with options for additional work. NIDA anticipates that at least one task order will be awarded with the contract. RFP No. N01DA-12-8902 will be available electronically on or about March 20, 2012. You can access the RFP through the FedBizOpps (URL: http://www.fedbizopps.gov or through the NIDA website at the following address: (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 we release 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.

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