7604 Federal Register / Vol. 75, No. 34 / Monday, February 22, 2010 / Notices 

grants at different times, we have 

assumed that new cohorts will replace 

previous cohorts. Therefore, the number 

of grantees in each year is assumed to 

be constant. 

TABLE—ESTIMATES OF ANNUALIZED HOUR BURDEN

Measure name Number of 

respondents 

Number of 

responses/ 

respondent 

Hours/ 

response 

Response 

burden 

(in hours) 

State/Tribal Cross-Site Evaluation Instruments 

Prevention Strategies Inventory—State Tribal (PSI–ST) .............................. 48 4 0 .75 144 

Training Exit Survey State/Tribal (TES–ST) .................................................. 94,848 1 0 .17 16,125 

Training Utilization and Penetration Survey (TUP–S) ................................... 2,000 1 0 .25 500 

Training Utilization and Penetration Interview (TUP–I) ................................. 100 1 0 .67 67 

Referral Network Survey (RNS) .................................................................... 1,024 1 0 .67 687 

Early Identification, Referral and Follow Up Analysis (EIRF) ........................ 48 4 1 192 

Early Identification, Referral and Follow Up Aggregate Screening Form 

(EIRF–S) .................................................................................................... 48 4 0 .33 64 

Training Exit Survey Cover Page State/Tribal (TES–CP–ST) ...................... 48 4 0 .33 64 

Campus Cross-Site Evaluation Instruments 

Prevention Strategies Inventory—Campus (PSI–C) ...................................... 38 4 0 .75 114 

Training Exit Survey Campus (TES–C) ......................................................... 23,712 1 0 .17 4,032 

Suicide Prevention Exposure, Awareness and Knowledge Survey—Student Version (SPEAKS–S) ......................................................................... 7,600 1 0 .42 3,192 

Suicide Prevention Exposure, Awareness and Knowledge Survey—Faculty/Staff (SPEAKS–FS) ............................................................................. 1,900 1 0 .25 475 

Campus Infrastructure Interview (CIFI) for Student ...................................... 38 1 0 .75 29 

Campus Infrastructure Interview (CIFI) for Faculty ....................................... 76 1 0 .75 57 

Campus Infrastructure Interview (CIFI) for Administrator .............................. 38 1 0 .75 29 

Campus Infrastructure Interview (CIFI) for Counselor .................................. 38 1 0 .75 29 

Training Exit Survey Cover Page Campus (TES–CP–C) ............................. 38 4 0 .33 51 

MIS Data Abstraction ..................................................................................... 38 4 0 .33 51 

Campus Case Studies Evaluation Instruments 

Focus Group—Student Version ..................................................................... 216 1 1 .5 324 

Focus Group—Faculty Version ..................................................................... 72 1 1 .5 108 

Focus Group—Staff Version .......................................................................... 36 1 1 .5 54 

Interview—Student Leader Version ............................................................... 8 1 1 8 

Interview—Case Finder Version .................................................................... 4 1 1 4 

Interview—Faculty Version ............................................................................ 8 1 1 8 

Interview—Campus Police Version ............................................................... 8 1 1 8 

Interview—Counseling Staff Version ............................................................. 8 1 1 8 

Interview—Prevention Staff Version .............................................................. 12 1 1 12 

Interview—Administrator Version .................................................................. 8 1 1 8 

Total ........................................................................................................ ........................ 132,060 .......................... 26,444 

Send comments to Summer King, 

SAMHSA Reports Clearance Officer, 

Room 7–1044, One Choke Cherry Road, 

Rockville, MD 20857 and e-mail a copy 

to summer.king@samhsa.hhs.gov. 

Written comments should be received 

within 60 days of this notice. 

Dated: February 5, 2010. 

Elaine Parry, 

Director, Office of Program Services. 

[FR Doc. 2010–3326 Filed 2–19–10; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0079] 

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, 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 statement provision of the Family 

Smoking Prevention and Tobacco 

Control Act (the Tobacco Control Act). 

DATES: Submit written or electronic 

comments on the collection of 

information by April 23, 2010. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 


cprice-sewell on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 34 / Monday, February 22, 2010 / Notices 7605 

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 (HFA–710), Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3794, 

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. 

Experimental Study of Graphic 

Cigarette Warning Labels 

Tobacco products are responsible for 

more than 440,000 deaths each year. 

The Centers for Disease Control and 

Prevention report that approximately 46 

million U.S. 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. 

On June 22, 2009, the President 

signed the Tobacco Control Act (Public 

Law 111–31) into law. The Tobacco 

Control Act granted 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. 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 1103(d)(2)(C) of the 

Federal Food, Drug, and Cosmetic Act, 

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. 

The study, the Experimental Study of 

Graphic Cigarette Warning Labels, is a 

voluntary 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 

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 BURDEN1

Portion of Study No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Pre-test 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 1 15,460 2,970 

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


cprice-sewell on DSK2BSOYB1PROD with NOTICES
7606 Federal Register / Vol. 75, No. 34 / Monday, February 22, 2010 / Notices 

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 pre-test 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 125 hours. Fifty-four hundred (5,400) 

respondents will complete the full 

study, estimated to last 30 minutes (0.5 

hours), for a total of 2,700 hours. The 

total estimated burden is 2,970 hours. 

Dated: February 16, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–3320 Filed 2–19–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Advisory Committee to the Director 

(ACD), Centers for Disease Control and 

Prevention (CDC): Notice of Charter 

Renewal 

This gives notice under the Federal 

Advisory Committee Act (Pub. L. 92– 

463) of October 6, 1972, that the 

Advisory Committee to the Director, 

Centers for Disease Control and 

Prevention of the Department of Health 

and Human Services, has been renewed 

for a 2-year period extending through 

February 1, 2012. 

Contact Person for More Information: 

Anne C. Haddix, PhD, Designated 

Federal Officer, ACD, CDC, 1600 Clifton 

Road, NE., M/S D14, Atlanta, Georgia 

30333. Telephone 404–639–0663. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Dated: February 11, 2010. 

Andre Tyler, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2010–3148 Filed 2–19–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control 

Special Emphasis Panel (SEP): 

Healthy Passages Longitudinal Study of 

Youth, Funding Opportunity 

Announcement (FOA) DP 10–007, 

Initial Review. 

In accordance with Section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the aforementioned meeting: 

Time and Date: 1 p.m.–3 p.m., April 20, 

2010 (Closed). 

Place: Teleconference. 

Status: The meeting will be closed to the 

public in accordance with provisions set 

forth in Section 552b(c)(4) and (6), Title 5 

U.S.C., and the Determination of the Director, 

Management Analysis and Services Office, 

CDC, pursuant to Public Law 92–463. 

Matters To Be Discussed: The meeting will 

include the initial review, discussion, and 

evaluation of applications received in 

response to ‘‘Healthy Passages Longitudinal 

Study of Youth, FOA DP 10–007.’’ 

Contact Person for More Information: 

Michael Dalmat, DRPH., Scientific Review 

Officer, National Center for Chronic Disease 

and Health Promotion, Office of the Director, 

Extramural Research Program Office, 4770 

Buford Highway, NE., Mailstop K–92, 

Atlanta, GA 30341, Telephone: (770) 488– 

6423, E-mail: MED1@cdc.gov. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities, for 

both CDC and the Agency for Toxic 

Substances and Disease Registry. 

Dated: February 10, 2010. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2010–3146 Filed 2–19–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–1996–N–0006] (formerly 

Docket No. 1996N–0277) 

Safety and Efficacy Review for 

Additional Ingredients in Over-theCounter Drug Products for Human 

Use; Request for Environmental 

Impact Data and Information 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Request for data and 

information. 

SUMMARY: We (Food and Drug 

Administration (FDA)) are requesting 

data and information regarding the 

potential environmental impact of 

amending over-the-counter (OTC) drug 

monographs to include certain active 

ingredients not previously marketed in 

the United States or marketed in the 

United States under approved 

applications after the OTC drug review 

began in 1972. Thirteen active 

ingredients have been found eligible for 

potential inclusion in OTC drug 

monographs based on time and extent 

applications (TEAs). We are currently 

evaluating the safety and effectiveness 

of these ingredients. 

DATES: Submit data, information, and 

general comments by May 24, 2010. 

ADDRESSES: Submit electronic or written 

data, information, and general 

comments in response to this document. 

Submit electronic comments to http:// 

regulations.gov. Submit written 

comments to the Division of Dockets 

Management HFA–305), 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Michael L. Koenig, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 5411, 

Silver Spring, MD 20993–0002, 301– 

796–2090. 

SUPPLEMENTARY INFORMATION: 

I. Ingredients Affected by This Notice 

We are currently evaluating the safety 

and effectiveness of 13 active 

ingredients found eligible for possible 

addition to an OTC drug monograph via 

the TEA process described in 21 CFR 

330.14. The ingredients under review 

are shown in table 1 of this document: 


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