52334 Federal Register / Vol. 76, No. 162 / Monday, August 22, 2011 / Notices 

Tobacco Product Reporting Violation 

Form (OMB Control Number 0910– 

NEW) 

On June 22, 2009, the President 

signed the Family Smoking Prevention 

and Tobacco Control Act (the Tobacco 

Control Act) (Pub. L. 111–31) into law. 

The Tobacco Control Act amended the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 321 et seq.) by 

adding a new chapter granting FDA 

important new authority to regulate the 

manufacture, marketing, and 

distribution of tobacco products to 

protect the public health generally and 

to reduce tobacco use by minors. 

FDA is requesting OMB approval for 

a new collection of information to 

accept consumer and other stakeholder 

feedback and notification of potential 

violations of the FD&C Act, as amended 

by the Tobacco Control Act. 

As part of its enforcement strategy, 

FDA created a Tobacco Call Center 

(with a toll-free number: 1–877–CTP– 

1373) to accept information from the 

public about violations of the Tobacco 

Control Act. Callers are able to report 

potential violations of the Tobacco 

Control Act and FDA will conduct 

targeted followup investigation based on 

information received. When callers 

report a violation, the caller will be 

asked to provide as much certain 

information as they can recall, 

including: The date the potential 

violation happened, the product type 

(e.g., cigarette, smokeless, roll-yourown, etc.), tobacco brand, type of 

potentially violative promotional 

materials, potential violation type, who 

potentially violated, and the name, 

address, phone number, and e-mail 

address of the potential violator. The 

caller will also be asked to list the 

potential violator’s Web site (if 

available), describe the potential 

violation, and provide any additional 

files or information pertinent to the 

potential violation. FDA has developed 

a form that will be used to solicit this 

information from the caller (FDA Form 

3779, Tobacco Product Violations 

Reporting), which is expected to 

eventually replace current form FDA 

Form 3734 for Cigarette Flavor Ban 

Violations. This new form will be 

posted on FDA’s Web site, and 

information may be submitted by filling 

out the form online (or the public can 

request a copy of Form 3779 by 

contacting the Center for Tobacco 

Products (CTP)). In addition, FDA has 

developed a smartphone application for 

use with iPhones, Android, etc. to allow 

consumers to report potential violations 

to FDA via their smartphone. Others 

may simply choose to send a letter to 

FDA with their information. In 

summary, the public will be able to 

report information regarding possible 

violations of the Tobacco Control Act 

through the following methods: calling 

the Tobacco Call Center using CTP’s 

toll-free number; using a fill-able form 

found on FDA’s Web site; using FDA’s 

tobacco violation reporting smartphone 

application, and sending a letter to 

FDA’s Center for Tobacco Products. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity and FDA Form 3779 Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Reporting violations of the FD&C Act, as amended by the 

Tobacco Control Act by telephone, Internet form, 

smartphone application, or mail ....................................... 1,000 1 1,000 0.167 167 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

FDA estimates that submitting the 

information (by phone, Internet form, 

smartphone application, or mail) will 

take 10 minutes. Since a similar type of 

reporting went into effect for the 

cigarette flavor ban, FDA has received 

several reports via the Internet or e-mail. 

Judging from the rate of reporting for the 

cigarette flavor ban, FDA estimates the 

number of respondents will be 1,000 

who will submit 1 report each annually 

by phone, Internet form, smartphone 

application, or mail. Because of the 

variety of products regulated by FDA 

under the authority of the FD&C Act, as 

amended by the Tobacco Control Act, 

FDA expects the rate of calls and reports 

received to remain steady over the next 

3 years. 

Dated: August 17, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–21381 Filed 8–19–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Arthritis Advisory Committee; Notice 

of Postponement of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is postponing the 

Arthritis Advisory Committee meeting 

scheduled for September 13, 2011. This 

meeting was announced in the Federal 

Register of July 19, 2011 (76 FR 42715). 

The postponement is due to the fact that 

the Agency recently received 

submissions from some of the 

investigational new drug (IND) 

application holders for anti-nerve 

growth factor (Anti-NGF) antibody drug 

products that contain large quantities of 

new information that will require 

additional time for Agency review prior 

to the advisory committee meeting. 

FOR FURTHER INFORMATION CONTACT: 

Philip A. Bautista, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–9001, FAX 301–827–8533, e-mail: 

AAC@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area), and follow the 

prompts to the desired center or product 

area. Please call the Information Line for 

up-to-date information on this meeting. 

Dated: August 17, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–21380 Filed 8–19–11; 8:45 am] 

BILLING CODE 4160–01–P 


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