9224 Federal Register / Vol. 75, No. 39 / Monday, March 1, 2010 / Notices 

Dated: February 24, 2010. 

Maryam I. Daneshvar, 

Reports Clearance Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2010–4177 Filed 2–26–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–10–10BT] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

In compliance with the requirement 

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

Paperwork Reduction Act of 1995 for 

opportunity for public comment on 

proposed data collection projects, the 

Centers for Disease Control and 

Prevention (CDC) will publish periodic 

summaries of proposed projects. To 

request more information on the 

proposed projects or to obtain a copy of 

the data collection plans and 

instruments, call 404–639–5960 or send 

comments to Maryam I. Daneshvar, CDC 

Acting Reports Clearance Officer, 1600 

Clifton Road, MS–D74, Atlanta, GA 

30333 or send an e-mail to 

omb@cdc.gov. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

National Quitline Data Warehouse — 

New—National Center for Chronic 

Disease Prevention and Health 

Promotion (NCCDPHP), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description: 

Despite the high level of public 

knowledge about the adverse effects of 

smoking, tobacco use remains the 

leading preventable cause of disease and 

death in the United States. Tobacco use 

results in approximately 440,000 deaths 

annually, including approximately 

38,000 deaths from secondhand smoke 

exposure. Adults who smoke contribute 

to $92 billion annually in lost worker 

productivity, and die an average of 14 

years earlier than nonsmokers. Although 

the prevalence of current smoking 

among adults decreased significantly 

since its peak in the 1960s, overall 

smoking prevalence among U.S. adults 

has remained virtually unchanged 

during the past five years. Large 

disparities in smoking prevalence 

continue to exist among members of 

racial/ethnic minority groups and 

individuals of low socioeconomic 

status. 

The National Tobacco Control 

Program (NTCP) was established by 

CDC to help reduce tobacco-related 

disease, disability, and death. The 

NTCP’s four goal areas are: (1) The 

prevention of initiation of tobacco use 

among young people, (2) the elimination 

of nonsmokers’ exposure to secondhand 

smoke, (3) the promotion of quitting 

among adults and young people, and (4) 

the elimination of tobacco-related 

disparities. The NTCP has provided 

funding for State quitlines, which 

provide telephone-based tobacco 

cessation services—including 

individualized counseling and self-help 

material—to help tobacco users quit. 

Quitlines overcome many of the barriers 

to tobacco cessation classes and 

traditional clinics because they are free 

and available at the caller’s 

convenience. Quitline services in all 

States can be accessed through a tollfree national portal number at 1–800– 

QUIT–NOW. According to CDC’s Best 

Practices for Comprehensive Tobacco 

Control, approximately six to eight 

percent of tobacco users potentially can 

be reached successfully by quitlines; 

however, currently, only one to two 

percent of tobacco users contact 

quitlines. 

All States collect intake information 

about quitline callers and the services 

provided to them, but have varied with 

respect to the schedule for follow-up 

with callers, the number of follow-up 

attempts per caller, and the collection of 

information related to follow-up. With 

leadership from the North American 

Quitline Consortium (NAQC) and other 

tobacco control organizations, the field 

has collaborated to develop a Minimum 

Data Set (MDS) consisting of a set of 

suggested intake questions that should 

be asked of all callers, and follow-up 

questions that should be asked of a 

representative sample of callers who 

have both completed intake and 

received a quitline service. 

CDC requests OMB approval to collect 

information for a National Quitline Data 

Warehouse (NDQW) based on a uniform 

follow-up protocol and standardized 

instruments adapted from the MDS. 

Respondents will be the 50 States, the 

District of Columbia, and Guam. 

Additional funding for the expansion of 

tobacco quitline services, 

standardization of the information 

collection, and transmission to the 

shared NQDW is provided under the 

American Recovery and Reinvestment 

Act of 2009 (ARRA). 

Intake information will be collected 

from approximately 60,833 callers per 

month over a 24-month period. Minimal 

information will be collected from 

callers who contact the Quitline on 

behalf of another person. The 

information collection will also include 

seven-month follow-up data from a 

random sample of approximately 3,400 

callers per month across all States, 

beginning in month eight (i.e., seven full 

months after the first intakes) and 

continuing through month 24. Finally, 

the Tobacco Control Manager for each 

ARRA awardee (State, district or 

territory) will be required to submit a 

quarterly report describing services 

provided. The quarterly report will be 

used to quantify improvements in the 

capacity of the quitlines to assist 

tobacco users over time and to evaluate 

the expenditure of Recovery Act dollars. 

The NQDW will have significant 

implications for the development of 

policies and programs aimed at tobacco 

use cessation and reduction of tobacco 

use. The information to be collected in 

the NQDW will be used to determine 

the role quitlines are playing in 

promoting tobacco use cessation, 

measure the number of tobacco users 

being served by State Quitlines, 

determine reach of quitlines to high-risk 

populations (e.g., racial and ethnic 

minorities and the medically 

underserved), measure the number 

using each State quitline who quit, 

determine whether some combinations 

of services contribute to higher quit 

rates than others, and improve the 

timeliness, access to, and quality of data 

collected by quitlines. 

CDC requests OMB approval to collect 

information for a two-year period. All 

information will be collected 

electronically. There are no costs to 

respondents other than their time. 

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Federal Register / Vol. 75, No. 39 / Monday, March 1, 2010 / Notices 9225 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden per 

response 

(in hours) 

Total 

burden 

(in hours) 

Caller who contacts the Quitline on behalf 

of someone else.

Intake Questionnaire ................................ 230,000 1 1/60 3,833 

Caller who contacts the Quitline for personal use.................................................................... 500,000 1 10/60 83,333 

Quitline caller who received a Quitline 

service.

Follow-up Questionnaire .......................... 28,900 1 7/60 3,372 

Tobacco Control Manager ........................ Quitline Services Questionnaire ............... 52 4 7/60 24 

Total ................................................... ................................................................... .................... .................... .................... 90,562 

Dated: February 23, 2010. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2010–4164 Filed 2–26–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0084] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Pretesting of 

Tobacco Communications 

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 

pretesting of tobacco communications. 

DATES: Submit written or electronic 

comments on the collection of 

information by April 30, 2010. 

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: 

Jonna Capezzuto, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3794, e-mail: Jonnalynn.capezzuto@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. 

Pretesting of Tobacco Communications 

In order to conduct educational and 

public information programs relating to 

tobacco use, as authorized by section 

903(d)(2)(D) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 

393(d)(2)(D)) and to develop stronger 

health warnings on tobacco packaging 

as authorized by the Family Smoking 

Prevention and Tobacco Control Act 

(Tobacco Control Act), it is beneficial 

for FDA to conduct research and studies 

relating to the control and prevention of 

disease as authorized by section 301 of 

the Public Health Service Act (42 U.S.C 

241(a)). In conducting such research, 

FDA will employ formative pretests to 

assess the likely effectiveness of tobacco 

communications with specific target 

audiences. The information collected 

will serve two major purposes. First, as 

formative research it will provide the 

critical knowledge needed about target 

audiences. FDA must first understand 

critical influences on people’s 

decisionmaking process when choosing 

to use, not use, or quit using tobacco 

products. In addition to understanding 

the decisionmaking processes of adults, 

it is also critical to understand the 

decisionmaking processes among 

adolescents (ages 13 to 17), where 

communications will aim to discourage 

tobacco use before it starts. Knowledge 

of these decisionmaking processes will 

be applied by FDA to help design 

effective communication strategies, 

messages, and warning labels. Second, 

as initial testing, it will allow FDA to 

assess the potential effectiveness of 

messages and materials in reaching and 

successfully communicating with their 

intended audiences. Pretesting messages 

with a sample of the target audience 

will allow FDA to refine messages while 

they are still in the developmental stage. 

By utilizing appropriate qualitative and 

quantitative methodologies, FDA will be 

able to: (1) Better understand 

characteristics of the target audience-its 

attitudes, beliefs, and behaviors-and use 

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