Federal Register / Vol. 76, No. 162 / Monday, August 22, 2011 / Notices 52333 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Survey type Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

(in hours) 

Total hours 

In-Person Surveys ............................................................... 7,500 1 7,500 1 7,500 

Remote Online Surveys ....................................................... 67,000 1 67,000 30/60 33,500 

Screener Only 2 .................................................................... 500 1 500 5/60 42 

Total .............................................................................. ........................ ........................ ........................ ........................ 41,042 

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

2These participants take the screener (which will be comprised of Demographic and/or Introductory Questions, attachments 5 and 6) but are 

not selected for the full survey. 

There will be two lengths of surveys 

conducted, depending on whether the 

survey is in-person or remote and 

online. An in-person survey will last an 

average of 60 minutes and take place at 

an FDA computer or at a 

nongovernmental location; a remote 

survey will last approximately 30 

minutes and take place at the 

participant’s computer. These estimates 

were determined through analysis of 

times from previous usability surveys 

using similar questions, a survey of 

usability professionals to ascertain 

average times for users to perform tasks, 

and a pilot survey of 10 internal users 

comprised of staff from the Centers for 

Disease Control and Prevention (CDC) 

and CDC contractors. Some remote 

surveys will take much less time. The 

majority of usability surveys conducted 

at CDC were done remotely; thus FDA 

estimates that in the future more 

surveys will be done remotely rather 

than in person. 

Estimate of survey respondents was 

based on an estimate of the ideal 

number of usability surveys that FDA 

would conduct over a 3-year period. 

Factored in were initial surveys and 

subsequent followup surveys utilizing a 

satisfactory level of participants. 

Because FDA has not conducted these 

types of surveys at the level needed 

previously, it is anticipated that most of 

FDA’s communications will require 

some sort of usability survey. 

Additionally, FDA anticipates 

conducting a number of important 

baseline surveys for its home Web page 

and other highly trafficked subsites in 

order to redesign these pages as part of 

FDA’s priority to more effectively utilize 

its Web site. 

Annually, FDA projects about 125 

studies using the variety of test methods 

listed previously. FDA is requesting this 

burden so as not to restrict the Agency’s 

ability to gather information on public 

sentiment for its proposals in its 

regulatory and communications 

programs. 

Dated: August 17, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–21379 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–0553] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Tobacco Product 

Reporting Violation Form 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the collection of information contained 

in FDA’s Tobacco Product Reporting 

Violation Form. 

DATES: Submit either electronic or 

written comments on the collection of 

information by October 21, 2011. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 


jlentini on DSK4TPTVN1PROD with NOTICES
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 


jlentini on DSK4TPTVN1PROD with NOTICES