18250 Federal Register / Vol. 77, No. 59 / Tuesday, March 27, 2012 / Notices 

Dated: March 20, 2012. 

Ron A. Otten, 

Director, Office of Scientific Integrity, Office 

of the Associate Director for Science (OADS), 

Office of the Director, Centers for Disease 

Control and Prevention. 

[FR Doc. 2012–7351 Filed 3–26–12; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0273] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Experimental 

Study of Graphic Cigarette Warning 

Labels 

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, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the Experimental Study of Graphic 

Cigarette Warning Labels that is being 

conducted in support of the graphic 

label provision of the Family Smoking 

Prevention and Tobacco Control Act 

(the Tobacco Control Act). 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 29, 2012. 

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, 

including each proposed extension of an 

existing 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. 

Experimental Study of Graphic 

Cigarette Warning Labels—(OMB 

Control Number 0910–0668)—Extension 

Tobacco products are responsible for 

more than 400,000 deaths each year. 

The Centers for Disease Control and 

Prevention report that approximately 46 

million adults smoke cigarettes in the 

United States, even though this behavior 

will result in death or disability for half 

of all regular users. Paralleling this 

enormous health burden is the 

economic burden of tobacco use, which 

is estimated to total $193 billion 

annually in medical expenditures and 

lost productivity. Curbing the 

significant adverse consequences of 

tobacco use is one of the most important 

public health goals of our time. One way 

to do this is through health warnings 

that describe and graphically depict the 

harm caused by cigarette use causing 

individuals to think harder about the 

choice to use tobacco. 

On June 22, 2009, the President 

signed the Tobacco Control Act (Public 

Law 111–31) into law. The Tobacco 

Control Act granted FDA authority to 

regulate the manufacture, marketing, 

and distribution of tobacco products to 

protect the public health generally and 

to reduce tobacco use by minors. 

Section 201 of the Tobacco Control Act, 

which amends section 4 of the Federal 

Cigarette Labeling and Advertising Act 

(15 U.S.C. 1333), requires FDA to issue 

‘‘regulations that require color graphics 

depicting the negative health 

consequences of smoking to accompany 

the label statements specified in 

subsection (a)(1).’’ FDA conducts 

research relating to tobacco products 

under its statutory authority in section 

1003(d)(2)(C) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 

393(d)(2)(C)), as amended by the 

Tobacco Control Act, to conduct 

research ‘‘relating to foods, drugs, 

cosmetics, devices, and tobacco 

products in carrying out the act.’’ The 

study proposed here is an effort by FDA 

to collect data concerning graphic 

warnings on cigarette packages and their 

impact on consumer perceptions, 

attitudes, and behavior with respect to 

smoking. 

On June 22, 2011, FDA issued a final 

rule in the Federal Register of June 22, 

2011 (76 FR 36628) entitled ‘‘Required 

Warnings for Cigarette Packages and 

Advertisements,’’ which specified nine 

graphic images to accompany the new 

textual warnings for cigarettes. 

Although the rule was scheduled to 

become effective 15 months after it 

issued, a federal district court has 

permanently enjoined FDA from 

implementing the rule in its current 

form. FDA has appealed this decision to 

the U.S. Court of Appeals of the District 

of Columbia. FDA expects that the 

information that FDA proposes to 

collect will be relevant to FDA’s 

regulation of cigarette warnings no 

matter the outcome of the current 

litigation. 

The study, the Experimental Study of 

Graphic Cigarette Warning Labels, is a 

voluntary annual experimental survey 

of consumers. The purpose of the study 

is to assess the effectiveness of various 

graphic warnings on cigarette packs for 

achieving three communication goals: 

(1) Conveying information about various 

health risks of smoking, (2) encouraging 

cessation of smoking among current 

smokers, and (3) discouraging initiation 

of smoking among youth and former 

smokers. The study will collect data 

from various groups of consumers, 

including current smokers aged 13 years 

and older, former smokers aged 13 years 

and older, and non-smokers aged 

between 13 and 25 years who may be 

susceptible to initiation of smoking. The 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 77, No. 59 / Tuesday, March 27, 2012 / Notices 18251 

study goals are to: (1) Measure 

consumer attitudes, beliefs, and 

intended behaviors related to cigarette 

smoking in response to graphic warning 

labels; (2) determine whether consumer 

responses to graphic warning labels 

differ across various groups based on 

smoking status, age, or other 

demographic variables; and (3) evaluate 

the relative effectiveness of various 

graphic images associated with each of 

the nine warning statements specified in 

the Tobacco Control Act for achieving 

each of the communication goals. The 

information collected from the study is 

necessary to inform the Agency’s efforts 

to implement the mandatory graphic 

warnings required by the Tobacco 

Control Act. 

The experimental study data will be 

collected from participants of an 

Internet panel of approximately 43,000 

people. Participation in the 

experimental study is voluntary. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Portion of study Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

Pretest ................................................................................ 60 1 60 0 .5 30 

Screener ............................................................................. 15,000 1 15,000 0 .016 240 

Experimental Survey .......................................................... 5,400 1 5,400 0 .5 2,700 

Total ............................................................................ ........................ ........................ ........................ .......................... 2,970 

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

FDA’s burden estimate is based on 

prior experience with Internet panel 

experiments similar to the study 

proposed here. Sixty panel members 

will take part in a pretest of the study, 

estimated to last 30 minutes (0.5 hours), 

for a total of 30 hours. Approximately 

15,000 respondents will complete a 

screener to determine eligibility for 

participation in the study, estimated to 

take 1 minute (0.016 hours), for a total 

of 240 hours. Fifty-four hundred 

respondents will complete the full 

study, estimated to last 30 minutes, for 

a total of 2,700 hours. The total 

estimated burden is 2,970 hours (30 

hours plus 240 hours plus 2,700 hours). 

Dated: March 21, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–7289 Filed 3–26–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

Development of Animal Models of 

Pregnancy To Address Medical 

Countermeasures for Influenza in the 

‘‘At Risk’’ Population of Pregnant 

Women: Influenza as a Case Study; 

Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration’s 

(FDA) Center for Drug Evaluation and 

Research and FDA’s National Center for 

Toxicological Research are announcing 

a 2-day public workshop entitled 

‘‘Development of Animal Models of 

Pregnancy To Address Medical 

Countermeasures for Influenza in the 

‘At Risk’ Population of Pregnant 

Women: Influenza as a Case Study.’’ 

The purpose of this workshop is to 

provide a forum to carefully consider 

scientific issues related to selecting 

animal models for use in evaluating 

medical influenza countermeasures 

(anti-influenza drugs) that may be given 

during pregnancy. Specifically, this 

workshop will address experimental 

design issues in selecting the most 

appropriate animal model that mimics 

human pregnancy. The goal is to use 

this model to evaluate how pregnancy 

changes the pharmacokinetics of antiinfluenza drugs in animals and compare 

those changes to the changes that are 

known to occur in human pregnancy. 

The data obtained from using this model 

may enhance the knowledge base 

needed to extrapolate the effects of 

pregnancy on other medical 

countermeasures. 

DATES: Date and Time: The public 

workshop will be held on April 30, 

2012, from 8:30 a.m. to 5 p.m., and on 

May 1, 2012, from 8:30 a.m. to 5 p.m. 

Location: The public workshop will 

be held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Central 

Shared Use (CSU) Bldg. 2, rm. 2047, 

Silver Spring, MD 20993–0002. 

Entrance for the public meeting 

participants (non-FDA employees) is 

through Building 1, where routine 

security check procedures will be 

performed, a visitor badge will be 

issued, and an escort will be provided 

to the meeting room. Governmentissued identification will be needed. For 

additional information on parking and 

security, please refer to http://www.fda.

gov/AboutFDA/WorkingatFDA/

BuildingsandFacilities/WhiteOak

CampusInformation/ucm241740.htm. 

Contact Person: For questions about 

the workshop, please contact Cindy de 

Sales, cindy@tepgevents.com, 240–316– 

3207. 

Registration: There is no fee to attend 

the public workshop, but attendees 

must register in advance. Space is 

limited, and registration will be on a 

first-come, first-served basis. Persons 

interested in attending this workshop 

must register online at http:// 

fda.contractmeetings.com before April 

16, 2012. Non-U.S. citizens are subject 

to additional security screening, and 

they should register as soon as possible. 

For those without Internet access, please 

contact Cindy de Sales (see Contact 

Person) to register. Onsite registration is 

not available. 

If you need special accommodations 

due to a disability, please contact Cindy 

de Sales (see Contact Person) at least 7 

days in advance. 

SUPPLEMENTARY INFORMATION: During 

seasonal and pandemic influenza 

outbreaks, pregnant women generally 

have greater morbidity and mortality 

than other adults. The data from the 

2009 H1N1 influenza pandemic 

suggested that pregnant women were at 

increased risk for medical 

complications. There is limited 

information regarding the efficacy, 

pharmacokinetics, optimal dosing, and 

side effects of anti-influenza drugs that 

may need to be used during pregnancy. 

The same is true for most drugs to treat 

diseases due to other infectious agents. 

The anti-influenza drugs have been 

selected for further study because the 

influenza virus can infect pregnant 

women, and oseltamivir, an antimstockstill on DSK4VPTVN1PROD with NOTICES