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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9226 Federal Register / Vol. 75, No. 39 / Monday, March 1, 2010 / Notices 

these in the development of effective 

risk communications; (2) more 

efficiently and effectively design 

messages and select formats that have 

the greatest potential to influence the 

target audience’s attitudes and behavior 

in a favorable way; (3) determine the 

best promotion and distribution 

channels to reach the target audience 

with appropriate messages; and (4) 

expend limited program resource 

dollars wisely and effectively. 

Frequency of Response: On occasion. 

Affected Public: Individuals or 

households; Type of Respondents: 

Members of the public, healthcare 

professionals; organizational 

representatives. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Type of Respondents No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Adolescents 13–17, and Adults 18+ 16,448 1 16,448 0.1739 2,860 

Total 2,860 

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

Dated: February 23, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–4098 Filed 2–26–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0066] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Human Tissue 

Intended for Transplantation 

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 information collection requirements 

relating to FDA regulations for human 

tissue intended for transplantation. 

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: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–3792. 

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. 

Human Tissue Intended for 

Transplantation—21 CFR Part 1270 

(OMB Control Number 0910–0302)— 

Extension 

Under section 361 of the Public 

Health Service (PHS) Act (42 U.S.C. 

264), FDA issued regulations under part 

1270 (21 CFR part 1270) to prevent the 

transmission of human 

immunodeficiency virus (HIV), hepatitis 

B, and hepatitis C through the use of 

human tissue for transplantation. The 

regulations provide for inspection by 

FDA of persons and tissue 

establishments engaged in the recovery, 

screening, testing, processing, storage, 

or distribution of human tissue. These 

facilities are required to meet provisions 

intended to ensure appropriate 

screening and testing of human tissue 

donors and to ensure that records are 

kept documenting that the appropriate 

screening and testing have been 

completed. 

Section 1270.31(a) through (d) 

requires written procedures to be 

prepared and followed for the following 

steps: (1) All significant steps in the 

infectious disease testing process under 

§ 1270.21; (2) all significant steps for 

obtaining, reviewing, and assessing the 

relevant medical records of the donor as 

prescribed in § 1270.21; (3) designating 

and identifying quarantined tissue; and 

(4) for prevention of infectious disease 

contamination or cross-contamination 

by tissue during processing. Section 

1270.31(a) and (b) also requires 

recording and justification of any 

deviation from the written procedures. 

Section 1270.33(a) requires records to be 

maintained concurrently with the 

performance of each significant step in 

the performance of infectious disease 

screening and testing of human tissue 

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