Ordering Guidelines for Nicotine Research Cigarettes (NRCs)

To obtain NRCs from the NIDA DSP, all research investigators will need to prepare a Request Package. A Request Package should include the following items:

1. A cover letter including:
   1. Name, phone number and e-mail address of Research Investigator (and consignee, if applicable).
   2. 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).
   3. The NIH grant number of project (if applicable) and the name and contact information of the project’s NIDA or other NIH Program Officer.  If not an NIH-funded project, please indicate other source(s) of funding.
   4. Type and quantity of NRCs being requested
      • If multiple studies/tasks are planned under the same NIH grant number, combine projected needs into a single order rather than placing several separate requests in a short time interval.
      • Provide NRC estimates in 6-month intervals for the duration of the project.
2. The research investigator’s curriculum vitae (CV).
3. A detailed research protocol clearly indicating:
   1. The specific aims and goals of the proposed study (preferably including the study abstract).
   2. Number of experiments and experimental subjects.
   3. Number and type of NRCs (see link to NRC Table), including respective Tobacco Product Master File (TPMF) codes.
      • Calculate required number of NRCs (by the carton) for your project and submit your request well in advance of your planned experiments or tasks, or at least 6-8 weeks prior to depletion of stock on-hand for ongoing studies/tasks.
   4. 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.
   5. A timeline indicating approximately when and what quantities of NRC shipments are needed over the duration of the protocol. Provide NRC estimates in 6-month intervals for the duration of the study.
   6. Statement of commitment that NIDA will be acknowledged in research publications using the NIDA-supplied cigarettes.
4. For Clinical Research Projects Involving Human Subjects:
   • Note that it is the responsibility of the Researcher to verify if their protocol requires an ITP. Please contact the FDA Center for Tobacco Products (CTP) via to verify if an ITP is needed or to ask any questions.
   • If it is determined that your protocol requires an ITP, please request a Letter of Authorization (LOA) by contacting the NRC mailbox.
     *See section below for more information about the ITP process.
   1. Investigational Tobacco Product (ITP) application information, including: A copy of the FDA letter (Advice/Information Request Letter) in response to your ITP application request. Suggested guidelines for submitting an Investigational Tobacco Product Application (ITPA) to the FDA/CTP may be found in the document at Use of Investigational Tobacco Products: Guidance for Industry and Investigators.
   2. A copy of your Institutional Review Board (IRB) approval letter.
   3. A copy of your Data Safety and Monitoring Plan.
   4. Proof of registration with clinicaltrials.gov (NCT #).
   5. A copy of the study consent form(s).
5. For Basic (Non-human) Research Projects:
   1. A copy of the document demonstrating that the research is approved by the Institutional Animal Care & Use Committee and that adequate care in conducting animal research will be exercised.  For more information, please visit the NIH Office of Laboratory Animal Welfare
6. Billing Information for Shipping Costs:
   1. US investigators should provide their FedEx account number to bill shipping charges.
   2. 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.

7. 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
   3040 East Cornwallis Road
   Hermann Bldg., Room 106
   Research Triangle Park, NC 27709-2194, 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 should also be aware that cigarettes 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 cigarettes 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.

*Investigational Tobacco Product (ITP) Application information

As noted above, researchers conducting studies with human participants will need to determine if an ITP is necessary prior to submitting their Nicotine Research Cigarette (NRC) order.  The researcher, their institution and IRB can determine whether an ITP is needed, given that NRCs are not a novel product for which there is limited experience and knowledge. Guidance is available on the FDA’s website: Use of Investigational Tobacco Products: Guidance for Industry and Investigators    Additional inquiries may be directed to the FDA CTP mailbox at: CTP-OS-ITP@fda.hhs.gov.

The email should:

• Describe the inquiry about the need for an ITP.
• Clearly and uniquely identify the Nicotine Research Cigarette product(s) you wish to study by TMPF code and Type.
• Provide additional available information such as a brief description of the study protocol and intended use of the product.

Once the FDA CTP receives the email inquiry, they will make every effort to respond via email within 2 weeks.

If an ITP is determined to be necessary for your project, an Investigational Tobacco Product (ITP) authorization must first be obtained from the FDA.  Guidance on how to file an ITP can be found in the document on the FDA’s website at: Use of Investigational Tobacco Products: Guidance for Industry and Investigators

• When filing the ITP application, you will need to include a Letter of Authorization (LOA) from the NIDA Drug Supply Program. Request the LOA by emailing NIDANRCSupply@mail.nih.gov
• The LOA indicates that your application has NIDA’s permission to cross-reference the SPECTRUM Tobacco Product Master File, which is on file with The FDA Center for Tobacco Products.
• See the FDA website for how to submit the ITP application to.

The FDA will respond with a response letter (i.e., an Advice/Information Request letter) which must be included in the NRC Request Packet. Below are helpful notes to assist with the ITP application process.  Please be consistent and as specific as possible throughout your ITP application.  If not, applications may be considered incomplete and delayed until corrected.

• If applicable, include date(s) of previously submitted ITPs for cross-reference.
• Reference the specific Tobacco Product Master File (TPMF) code name for the requested nicotine research cigarette(s) (NRCs) (e.g., NRC 300, RN).
• Provide the specific grant number (e.g., R01DA123456) and title (where appropriate); the project and/or protocol number and title; and the name of the PI for the study.
• Please identify the name of the study sponsor. Note the distinction between “sponsor” and “investigator:” Sponsors are typically considered to be the awarded institution (for NIH grants) to which the funding will be designated. Investigators are the primary research contact who conducts the research at that particular institution.
• The title of SPECTRUM cigarettes should be in all caps and consistent throughout your ITP application.

All inquiries and requests for the Investigational Tobacco Product application should be forwarded to the:

Food and Drug Administration
Center for Tobacco Products
Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD  20993-0002

CTP-OS-ITP@fda.hhs.gov

Contact Information:

All requests/questions should be sent to: NIDANRCSupply@mail.nih.gov(link sends email). Please specify substance requested in the subject line.

¹Reference information includes previous approvals for protocols used on previous projects; and previous research chemicals and compounds requested.