Document ID: FDA-2014-N-1208-0001
Agency: fda
Document Type: Notice
Title: Laboratory Site Tours Program
Posted Date: 2014-10-07T04:00Z

[Federal Register Volume 79, Number 194 (Tuesday, October 7, 2014)]
[Notices]
[Pages 60477-60478]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-23844]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1208]

Laboratory Site Tours Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration's (FDA's) Center for Tobacco 
Products' (CTP) Office of Science is announcing an invitation for 
participation in its Laboratory Site Tours Program. This program is 
intended to give CTP staff an opportunity to visit facilities involved 
in the testing and analysis of tobacco products and tobacco smoke. 
These visits are intended to provide CTP staff with the opportunity to 
gain a better understanding of tobacco science and laboratory 
operations and are not intended as regulatory inspections or facility 
visits for the purposes of developing Tobacco Product Manufacturing 
Practice regulations. The purpose of this notice is to invite parties 
interested in participating in the Laboratory Site Tours Program to 
submit their requests to CTP.

DATES: Submit either an electronic or written request for participation 
in this program by December 8, 2014. The request should include a 
description of your facility, including, as applicable, a list of the 
types of testing and analyses of tobacco products and tobacco smoke 
performed. Please specify the physical address(es) of the site(s) for 
which you are submitting a request, along with a proposed 1-day tour 
agenda.

ADDRESSES: If your facility is interested in offering a site visit, 
submit either an electronic request to http://www.regulations.gov or a 
written request to the Division of Dockets Management (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852.

FOR FURTHER INFORMATION CONTACT: Carolyn Dresler, Center for Tobacco 
Products, Food and Drug Administration, 10903 New Hampshire Ave., 
Document Control Center, Bldg. 71, rm. G335, Silver Spring, MD 20993-
0002, 240-402-4067, carolyn.dresler@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    On June 22, 2009, the Family Smoking Prevention and Tobacco Control 
Act (Pub. L. 111-31) was signed into law, amending the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) and giving FDA authority to 
regulate tobacco product manufacturing, distribution, and marketing.
    CTP's Office of Science is conducting the Laboratory Site Tours 
Program to provide its scientific and regulatory staff the opportunity 
to gain a better understanding of tobacco science and laboratory 
operations, to include tobacco product testing and analysis. CTP's goal 
for the Laboratory Site Tours Program is for its staff to gain: (1) 
Firsthand exposure to laboratories that perform tobacco product testing 
and (2)

[[Page 60478]]

knowledge of product analyses used by tobacco product manufacturers to 
ensure product consistency.

II. Description of Site Tours Program

    In the Laboratory Site Tours Program, small groups of CTP staff 
plan to observe the operations of laboratories that perform testing and 
analyses of tobacco products and tobacco smoke relative to analytical 
chemistry, microbiology, toxicology, biomarkers of exposure or risk, 
and analytical method development. Please note that the Laboratory Site 
Tours Program is not intended to include official FDA inspections of 
facilities to determine compliance with the FD&C Act or for the 
purposes of developing Tobacco Product Manufacturing Practice 
regulations; rather, the program is meant to educate CTP staff and 
improve their understanding of laboratory testing and analyses used by 
the tobacco industry.

III. Site Selection

    CTP plans to select a wide variety of laboratories that include 
academic, private, and those affiliated with tobacco manufacturers. All 
travel expenses associated with the site tours will be the 
responsibility of CTP. Final site selections will be based on the 
availability of CTP funds and resources for the relevant fiscal year, 
as well as the following factors, if applicable: (1) Compliance status 
of the requesting facility and affiliated firm, (2) whether the 
requesting facility is in arrears for user fees, and (3) whether the 
requesting facility or affiliated firm has a significant request or 
marketing application or submission pending with FDA.

IV. Requests for Participation

    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 Division of Dockets Management 
(see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: September 30, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-23844 Filed 10-6-14; 8:45 am]
BILLING CODE 4164-01-P