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Study Agent Labeling and Distribution

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Contract Overview

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This subcontract with the National Institutes of Health under the Department of Health and Human Services focuses on the labeling and distribution of study agents for prime contractors involved in NIAID clinical trials. The selected provider is responsible for pharmacy management, cold-chain distribution, and the delivery of medications, requiring specific pharmacy licensure and the ability to maintain blinding and masking protocols. The project is categorized under NAICS code 446110 and was posted on June 16, 2026, with a response deadline of July 5, 2029. The primary objective is to ensure the secure and professional handling of study agents to support the integrity of clinical research operations.

General Info

NIH subcontract for pharmacy management, labeling, and distribution of NIAID clinical trial agents.

Agency

Department Of Health And Human Services → National Institutes Of Health

NAICS

446110 - Pharmacies and Drug StoresView NAICS

Place of Performance

Not specified

Set-Aside

NONE

Documents

This scope was carved out of PAR-27-064.

The full solicitation package (1 document), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)

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Timeline

Posted

subcontract

Response Deadline

Submission deadline

Response Deadline

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health
ContactsNo contacts available
OfficeN/A
Organization / Agency
Department Of Health And Human Services → National Institutes Of Health
Office AddressN/A
ContactsNo contact information available

Full Description

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Supplies and manages the labeling and distribution of study agents for prime contractors on NIH/NIAID clinical trials. Performs labeling of study agents, cold-chain distribution, and pharmacy management. Requires pharmacy licensure and blinding/masking capabilities. Delivers labeled and distributed study agents and medications.

Similar Contracts

Same NAICS industry code

NAICS: 446110
Federal
Specialty Pharmacy Fulfillment of Lenalidomide (Revlimid)The contract involves the specialty pharmacy fulfillment and delivery of Lenalidomide (Revlimid), a medication used primarily in the treatment of certain cancers and blood disorders, to patients of the Department of Veterans Affairs (VA). The contractor is responsible for dispensing either branded or therapeutically equivalent versions of Lenalidomide in varying strengths. This service must comply with Risk Evaluation and Mitigation Strategies (REMS) protocols, ensuring safe and effective use of the medication. Essential contract activities include verifying prescriptions, conducting patient outreach to support medication adherence and understanding, securely packaging the medication, and ensuring delivery is confirmed by obtaining signatures upon receipt. This subcontract is issued by the 252-NETWORK Contract Office 12 under the Department of Veterans Affairs and aligns with NAICS code 446110, which typically covers pharmacies and drug stores. While specific performance location details and points of contact are not provided, the contract underscores the importance of compliance with federal safety standards and thorough patient management. The seamless coordination of prescription verification, patient communication, packaging, and secure delivery highlights the contractor’s critical role in supporting VA patients’ access to this specialized pharmaceutical therapy.
252-NETWORK Contract Office 12 (36C252)

POSTED

8 months ago

DEADLINE

N/A
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