Purity Specifications, Storage and Distribution for Medications Development

Notice ID:

N01DA-22-8961

Department/Ind. Agency:

HEALTH AND HUMAN SERVICES, DEPARTMENT OF

Sub-tier:

HEALTH AND HUMAN SERVICES, DEPARTMENT OF

Sub Command:

NATIONAL INSTITUTES OF HEALTH NIDA

Office:

NATIONAL INSTITUTES OF HEALTH NIDA

All Dates/Times are:

(utc-05:00) eastern standard time, new york, usa

Updated Published Date:

(utc-05:00) eastern standard time, new york, usa

Original Published Date:

0000-00-00 00:00:00

Original Response Date:

dec 23, 2021

Inactive Policy:

manual

Original Inactive Date:

feb 28, 2022

Initiative:

• None***--***

Product Service Code:

an11 - health r&d services; health care services; basic research

NAICS Code:

541715 - research and development in the physical, engineering, and life sciences (except nanotechnology and biotechnology)

Original Set Aside:

The National Institute on Drug Abuse (NIDA) plans to solicit proposals under full and open competition procedures from qualified organizations having the capability to act as a centralized repository for compounds from domestic and international investigators, commercial sources, and pharmaceutical companies. Specifically, the project requires the following tasks: 1. Receive and store compounds from various sources: Store approximately 10,000 existing compounds ranging in quantity from milligrams to kilograms Store compounds in various conditions ranging from room temperature to -80° C; from inert atmosphere to desiccated atmosphere; and from high security storage to normal lock and key Receive and store new compounds received from various sources Obtain proper permits and coordinate logistics for receipt of compounds from foreign sources Dispose of compounds that may potentially be neurotoxins or biohazardous 2. Purchase commercially available compounds: Acquire compounds from commercial suppliers Obtain and transpose all analytical information (e.g., complete chemical structure, solubility, etc.) for purchased compounds 3. Analyze compounds received from various sources: Perform Thin Layer Chromatography (TLC) analysis Perform High Performance Liquid Chromatography (HPLC) analysis Perform Mass Spectrometry (MS) analysis Perform Gas Chromatography (GC) analysis Perform Nuclear Magnetic Resonance (NMR) analysis Perform Optical Rotation analysis Interpret and report results to the COR 4. Ship compounds to domestic and international test sites: Package and ship compounds Prepare shipments as blinded samples Prepare shipments according to specified shipping conditions (i.e., dry ice, inert environment, desiccant, etc.) 5. Maintain an extensive, secure, web-based inventory and tracking system Maintain a centralized database tracking receipt, analysis, inventory coding, distribution, and other data for all compounds Update database on a daily basis Secure and maintain all records confidentially Meet DEA record keeping requirements for scheduled compounds NIDA anticipates the award of a single, one year, cost reimbursement contract with four one year option periods. This award is a competitive renewal of HHSN271201700034C, titled "Purity Specifications, Storage and Distribution for Medications Development." MANDATORY CRITERIA In order to handle substances under the Controlled Substances Act of 1970, it is mandatory that offerors possess a DEA Registration for Chemical Analysis or Research Registration for Schedules II to V and demonstrate the capability to obtain a DEA registration for Schedule I controlled substances. NOTICE RFP No. N01DA-22-8961 will be available electronically after 15 days from the date of this posting. You can access the RFP through the SAM.gov. All information required for the submission of a proposal will be contained in or accessible through the RFP package. Responses to the RFP will be due 45 days from the release date. NIDA anticipates a July 2022 award date. 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 or organizations 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.

c/o 3WFN MSC 6012 301 N Stonestreet Ave

Bethesda , MD 20892

USA

Primary Point of Contacts:

Polina Klimenkova

Secondary Point of Contact:

KJ Shaikh