Revised February 2018
1. A cover letter including:
Name, phone number and e-mail address of Research Investigator (and consignee, if applicable),
- Provide a current and complete address that would allow shipment by a suitable carrier such as Federal Express (FedEx) (i.e., street address, building name or number, room number, city and state),
- If applicable, NIH grant number of project and name and contact information of project’s NIDA/NIH Program Officer. If a non-NIH grantee, no information on Program Officer and grant number is required.
Type and quantity of NRCs being requested,
- If multiple studies/tasks are planned, combine projected needs into a single order rather than placing several separate requests in a short time interval. The request should generally be limited to four items or drugs/compounds per order to avoid delay.
2. The Research Investigator’s curriculum vitae (CV).
3. A detailed research protocol clearly indicating:
- The specific aims and goals of proposed study (preferably the study abstract)
- Number of experiments and experimental subjects
Number and type of NRCs (NOT-DA-14-004), including respective Tobacco Product Master File (TPMF) codes,
- Calculate required amount of NRCs for your project and submit your request well in advance of your planned experiments or tasks, or 6?8 weeks prior to depletion of stock on hand for ongoing studies/tasks.
- Justification for the quantity needed. If the request is related to a previously submitted protocol, provide a reference to this protocol and a brief statement of progress along with references to resulting publications.
- A timeline indicating approximately when and what quantities of NRC shipments are needed over the duration of the protocol.
- Statement of commitment that NIDA will be acknowledged in research publications using the NIDA-supplied cigarettes.
4. For Clinical Research Projects Involving Human Subjects
- Investigational Tobacco Product (ITP) application information including: A copy of FDA letter (Advice/Information Request) in response to your ITP application. (NOTE: Suggested guidelines for submitting an Investigational Tobacco Product Application (ITPA) to FDA/CTP(PDF, 983KB) are given separately.
- A copy of your Institutional Review Board (IRB) approval letter
- A copy of your Data Safety and Monitoring Plan
- Proof of registration with clinicaltrials.gov (NCT #)
- A copy of the study consent form(s)
5. For Basic (Non-human) Research Projects
- A copy of the document demonstrating that the research is approved by the Animal Care & Use Committee and that adequate care in conducting animal research will be exercised. For more information, please visit the Animal Care & Use Committee Animal Study Proposal website.
6. For Ongoing Research Projects (This includes research previously supported by the NIH prior to NRC request)
- Reference information pertaining the previous protocol1 / FDA approval to the previous protocol (if applicable).
- A brief statement of progress (500 words or less)
- A list of any relevant publications.
7. Billing Information for Shipping Costs:
- US investigators should provide their FedEx account number to bill shipping charges,
- International requests for controlled compounds should provide their United Parcel Service (UPS) Supply Chain Solutions account number to bill shipping charges. For non-controlled compounds the investigator should provide their FedEx account number.
8. For Foreign Investigators, please submit the Import Permit (preferably in English) issued by an appropriate agency of your government if the request is for an internationally controlled drug substance. The name of the supplier on the import permit must be listed as follows:
Research Triangle Institute
Kenneth S. Rehder Ph.D.
Hermann Building , East Institute Drive
P.O. Box 12194
Research Triangle Park, NC 27709, USA
- The import permit should be accompanied by a signed statement from the investigator to the effect that the drug will be used solely for the purpose of research and will not be re-exported. The import permit must contain a clear address and individual name to which the requested drug is to be delivered (not a post office box number). Shipment should be indicated on the import permit as Air Freight to this individual. Specify the appropriate port for customs clearance purposes and provide the name and address of the Customs Clearance Agent, if one is used.
- Please obtain the longest possible expiration date on import permits.
- Foreign investigators requesting drugs or other substances that are not very stable should be certain to make advance arrangements that would allow these drugs or other substances to be released to them expeditiously. This is particularly relevant when dealing with radioactive materials with high specific activity (>1.0 Ci/mmol). These compounds are shipped as solutions in ice and will not stay cold for more than 48 hours; they must be retrieved and put in cold storage immediately to prevent decomposition.
- Foreign investigators should also be aware that compounds are shipped with a listed value for insurance purposes. Since this may cause problems with customs officials, investigators should determine in advance what steps should be taken to avoid these complications. Often an official statement that the compounds are for research only and have no commercial value is sufficient.
Failure to comply with aforesaid guidelines is likely to delay the processing of your request.
a For more information, about the Investigational Tobacco Product (ITP) application, please refer to the Ordering Guidelines for Nicotine Research Cigarettes.
b Members of the Scientific Expert Committee includes subject matter experts, identified by the NIDA Drug Supply Program.
All requests/questions should be sent to: NIDANRCSupply@mail.nih.gov. Please specify substance requested in the subject line.
Address correspondence to:
Rik Kline, Ph.D.
Chemistry and Pharmaceutics Branch
Division of Therapeutics and Medical Consequences
6001 Executive Boulevard, Room #4119, MSC 9555
Bethesda, MD 20892-9555
Phone: (301) 827-5243
Fax: (301) 443-2599
1Reference information includes previous approvals for protocols used on previous projects; and previous research chemicals and compounds requested.