Document ID: FDA-2019-N-2037-0001
Agency: fda
Document Type: Notice
Title: Electronic Nicotine Delivery System Device and E-Liquid Manufacturer Site
Tours Program
Posted Date: 2019-05-24T04:00Z

[Federal Register Volume 84, Number 101 (Friday, May 24, 2019)]
[Notices]
[Pages 24157-24158]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10898]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-2037]

Electronic Nicotine Delivery System Device and E-Liquid 
Manufacturer Site Tours Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA), Center for Tobacco 
Products (CTP), is announcing an invitation for participation in its 
voluntary Electronic Nicotine Delivery System (ENDS) Device and E-
Liquid Manufacturer Site Tours Program. This program is intended to 
give CTP staff an opportunity to visit facilities that develop, 
manufacture, or test ENDS devices or e-liquids (including pods or 
cartridges) to gain a better understanding of the processes involved in 
the development, manufacturing, and testing of ENDS devices and e-
liquids. The site tours in this program are not intended as regulatory 
inspections. The purpose of this document is to invite ENDS device or 
e-liquid manufacturers that can demonstrate assembly process and 
present supply chain information, and laboratories that conduct ENDS 
aerosol and e-liquid testing, that are interested in participating in 
the ENDS Device and E-Liquid Manufacturer Site Tours Program to submit 
requests to CTP.

DATES: Submit either an electronic or written request for participation 
in this program by July 23, 2019. See section IV of this document for 
information on requests for participation.

ADDRESSES: If your facility is interested in participating in a 
facility visit, please submit a request either electronically to 
https://www.regulations.gov or in writing to the Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Karla Price, Office of Science, Center 
for Tobacco Products, Food and Drug Administration, Document Control 
Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 
20993-0002, 1-877-287-1373, email: AskCTP@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    On June 22, 2009, the Family Smoking Prevention and Tobacco Control 
Act (Pub. L. 111-31) (Tobacco Control Act) was signed into law, 
amending the Federal Food, Drug, and Cosmetic Act (FD&C Act) by, among 
other things, adding a new chapter (chapter IX) granting FDA the 
authority to regulate tobacco product manufacturing, distribution, and 
marketing. The Tobacco Control Act provides FDA authority to regulate 
cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless 
tobacco, and any other tobacco products that the Agency by regulation 
deems to be subject to the law.
    On May 10, 2016, FDA published a final rule entitled ``Deeming 
Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic 
Act, as Amended by the Family Smoking Prevention and Tobacco Control 
Act; Restrictions on the Sale and Distribution of Tobacco Products and 
Required Warning Statements for Tobacco Products'' (81 FR 28974), which 
became effective on August 8, 2016. Under this rule, all products, such 
as ENDS, that meet the statutory definition of ``tobacco product'' set 
forth in section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)), including 
components and parts, but excluding accessories of newly deemed 
products, are now subject to chapter IX of the FD&C Act.
    CTP's Office of Science is conducting the ENDS Device and E-Liquid 
Manufacturer Site Tours Program to provide its staff an opportunity to 
visit facilities that develop, manufacture, or test ENDS devices or e-
liquids (including pods or cartridges). The ENDS device and e-liquid 
facilities are regulated by FDA if they, among other things, 
manufacture products that meet the statutory definition of a ``tobacco 
product'' set forth in section 201(rr) of the FD&C Act. The site tours 
will aid the Agency in gaining a better understanding of the processes 
involved in developing, manufacturing, and

[[Page 24158]]

testing ENDS devices and e-liquids (including pods or cartridges).

II. Description of ENDS Device and E-Liquid Manufacturer Site Tours 
Program

    In the ENDS Device and E-Liquid Manufacturer Site Tours Program, 
CTP staff will observe the operations of ENDS device and e-liquid 
manufacturers, including the development, manufacturing, and testing of 
ENDS devices and e-liquids. The site tours in this program are not 
intended as regulatory inspections; rather, the program is meant to 
educate CTP staff and improve their understanding of ENDS devices and 
e-liquids. It is anticipated that the site tours will take place in 
2020.

III. Site Selection

    CTP hopes to be able to tour the facilities of different size 
manufacturers of ENDS devices, as well as facilities that develop or 
manufacture e-liquids (including pods and cartridges). This includes 
laboratories that test e-liquids or aerosols. Final site selections 
will be based on the availability of funds and resources for the 
relevant fiscal year as well as the desire to visit a wide variety of 
ENDS device and e-liquid manufacturers. FDA plans on visiting five or 
fewer ENDS device or e-liquid manufacturers. All travel expenses 
associated with the ENDS Device and E-Liquid Manufacturer site tours 
will be the responsibility of FDA.

IV. Requests for Participation

    To aid in site selection, your request for participation should 
include the following information:
     A description of your company, including the size of the 
organization;
     A list of the ENDS devices and e-liquids your company 
develops or manufactures, including whether the company performs e-
liquid and aerosol testing;
     The name and contact information (including address, phone 
number, and email) of your point of contact for the request;
     The physical address(es) of the site(s) for which you are 
submitting a request; and
     A proposed 1-day agenda that will aid with planning 
travel, indicating start and end times and provides addresses of all 
sites during the tour.
    Identify requests for participation with the docket number found in 
brackets in the heading of this document. Received requests are 
available for public examination in the Dockets Management Staff (see 
ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: May 20, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-10898 Filed 5-23-19; 8:45 am]
 BILLING CODE 4164-01-P