Federal Register / Vol. 76, No. 74 / Monday, April 18, 2011 / Notices 21753 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/ 

RegulatoryInformation/Guidances/ 

ucm122047.htm or http:// 

www.regulations.gov. 

Dated: April 11, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–9261 Filed 4–15–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0240] 

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 

a notice for participation in its Site 

Tours Program. This program is 

intended to give CTP staff an 

opportunity to visit facilities involved 

in the growing, processing, or 

manufacturing of tobacco or tobacco 

products. These visits are intended to 

provide CTP staff with the opportunity 

to gain a better understanding of the 

tobacco industry and its operations. The 

purpose of this notice is to alert parties 

interested in participating in the Site 

Tours Program to submit requests to 

CTP. 

DATES: Interested parties should submit 

either an electronic or written request 

for participation by June 17, 2011. The 

request should include a description of 

your facility, including as applicable, a 

list of all tobacco products processed 

and/or manufactured there. 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, you should 

submit a request to participate in the 

program either electronically to http:// 

www.regulations.gov or in writing to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Lucinda Miner, Center for Tobacco 

Products, Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850, 877–287–1373, 

e-mail: lucinda.miner@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On June 22, 2009, the Family 

Smoking Prevention and Tobacco 

Control Act (Pub. L. 111–31; 123 Stat. 

1776) 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. This includes, among other 

things, the authority to issue regulations 

related to health warnings, tobacco 

product standards, good manufacturing 

practices, as well as tobacco product 

constituents, ingredients, and additives. 

CTP is instituting the Site Tours 

Program to provide its scientific and 

regulatory staff the opportunity to gain 

a better understanding of the tobacco 

industry and its operations, including 

tobacco product manufacturing and 

aspects of tobacco growing, processing, 

and storage that may affect the physical 

and chemical properties of tobacco. 

Although FDA generally does not 

regulate tobacco farms and tobacco 

warehouses, the Agency believes that 

gaining a better understanding of the 

operations performed at these facilities 

may be helpful. The goals of the Site 

Tours Program are to: (1) Provide CTP 

firsthand exposure to industry’s 

manufacturing processes; (2) learn about 

control measures used by tobacco 

product manufacturers to ensure 

product consistency; (3) understand the 

processing of different forms of tobacco 

and the manufacturing processes used 

for various types of tobacco products 

and their influences on product 

constituents; and (4) understand how 

growing conditions, curing, storage, and 

manufacturing processes might 

influence the levels of tobacco or 

tobacco smoke constituents. 

II. Description of Site Tours Program 

In the Site Tours Program, small 

groups of CTP staff plan to observe the 

operations of tobacco growers, tobacco 

warehouses, and manufacturing 

facilities of cigarette, roll-your-own, and 

smokeless tobacco companies. Please 

note that the Site Tours Program is not 

intended to include official FDA 

inspections of facilities to determine 

compliance with the FD&C Act; rather, 

the program is meant to educate CTP 

staff and improve their understanding of 

the tobacco industry and its operations. 

III. Site Selection 

CTP plans to select one or more of 

each of the following types of facilities: 

A large cigarette manufacturing facility, 

a small cigarette manufacturing facility, 

a smokeless tobacco manufacturing 

facility, a burley tobacco farm, a fluecured tobacco farm, a tobacco rolling 

paper facility, and a tobacco warehouse. 

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: 

(1) Compliance status of the requesting 

facility and affiliated firm, if applicable; 

(2) whether the requesting facility is in 

arrears for user fees; (3) whether the 

requesting facility or affiliated firm, if 

applicable, has a significant request or 

marketing application or submission 

pending with FDA; and (4) whether the 

requesting facility will be engaged in 

active manufacturing or processing 

during the proposed time of the visit. 

IV. Requests for Participation 

Requests are to be identified with the 

docket number found in brackets in the 

heading of this document. Requests 

received by the Agency 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: April 11, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–9260 Filed 4–15–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Noncompetitive Program Extension 

Supplemental Awards 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice. 


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