27144 Federal Register / Vol. 74, No. 108 / Monday, June 8, 2009 / Notices 

Promotion (NCCDPHP), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

CDC currently supports the National 

Program of Cancer Registries (NPCR), a 

group of central cancer registries in 45 

states, the District of Columbia, and 2 

territories. The central cancer registries 

are data systems that collect, manage, 

and analyze data about cancer cases and 

cancer deaths. NPCR-funded central 

cancer registries submit populationbased cancer incidence data to CDC on 

an annual basis (OMB No. 0920–0469, 

exp. 1/31/2010). In addition, NPCRfunded registries submit program and 

performance indicator information to 

CDC on a semi-annual schedule (OMB 

No. 0920–0706, exp. 12/31/2011). CDC 

uses the performance indicators to 

evaluate the registries’ use of funds, 

their progress toward meeting 

objectives, and their infrastructure and 

operational attributes. 

Central cancer registries report that 

they are chronically understaffed, and 

many registries are concerned about the 

impact of staff shortages on data quality 

standards. Staffing patterns are known 

to vary widely from registry to registry, 

and registries differ greatly in the 

number of incidence cases that they 

process as well as their use of 

information technology. Cancer 

registries have asked for clear staffing 

guidelines based on registry 

characteristics such as size (i.e., number 

of new cases annually), degree of 

automation, and registry-specific 

reporting procedures. 

CDC proposes to conduct a one-time 

Workload Management Survey (WLM) 

in 2009–2010 to inform the 

development of staffing guidelines for 

central cancer registries. The WLM 

survey questions do not duplicate the 

program and performance indicator 

information reported to CDC on a 

routine basis. Respondents will be 

cancer registrars in the NPCR-funded 

central cancer registries in 45 states and 

the District of Columbia. Cancer 

registrars at each registry will maintain 

a paper-based Work Activities Journal 

for a one-week period. At the end of the 

week, the registry manager will 

consolidate the individual journal 

worksheets to prepare an aggregate 

Workload Management Survey for the 

registry, which will be submitted to 

CDC electronically. 

Results of the WLM survey will 

enable CDC to assess the workforce 

necessary for meeting data reporting 

requirements and to estimate the impact 

of planned changes to surveillance data 

reporting. Finally, CDC will develop 

specific guidance so that cancer registry 

managers can more effectively measure 

workload, evaluate the need for staff 

and staff credentials, and advocate for 

adequate staffing. 

Participation in the survey is 

voluntary. There are no costs to 

respondents other than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

NPCR Registries ............................ Workload Management Survey ..... 46 1 4 184 

Work Activities Journal .................. 368 1 2 736 

Total ........................................ ........................................................ ........................ .......................... .......................... 920 

Dated: June 1, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–13302 Filed 6–5–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–09–09BU] 

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 Adult Tobacco Survey 

(NATS)—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 

from 1998 to 2007 in 44 states, the 

District of Columbia, and Puerto Rico, 

only one state and one territory have 

met Healthy People 2010 targets for 

reducing adult smoking prevalence to 

12%, and six states have shown no 

substantial changes in prevalence after 

controlling for age, sex, and race/ 

ethnicity. 

The National Tobacco Control 

Program (NTCP) was established by 

CDC to help reduce tobacco-related 


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Federal Register / Vol. 74, No. 108 / Monday, June 8, 2009 / Notices 27145 

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. 

CDC proposes to conduct the National 

Adult Tobacco Survey (NATS) in order 

to collect essential information on key 

indicators of the effectiveness for the 

NTCP. The NATS will be a one-time, 

stratified, random-digit dialed telephone 

survey of non-institutionalized adults 

18 years of age and older. In order to 

yield results that are representative and 

comparable at both national and state 

levels, information will be collected 

from 3,000 respondents per state and 

the District of Columbia. In addition, a 

total of approximately 3,000 interviews 

will be conducted specifically from a 

national sample of cell phone users in 

an attempt to include the growing 

population of households that 

exclusively use cell phones and would 

be missed in a survey relying only on 

land-lines. 

Information collected through the 

NATS will be used to: (1) Generate 

state-level estimates of tobacco use for 

males and females, (2) generate statelevel estimates of tobacco use for 

minority groups comprising a major 

component of a given state’s population, 

(3) develop estimates of tobacco use at 

the national level by gender and race/ 

ethnicity, and (4) support the evaluation 

of comprehensive state-based Tobacco 

Control Programs using key outcome 

indicators at the state and national 

levels. Study results will have 

significant implications for the 

development of policies and programs 

aimed at preventing or reducing tobacco 

use. There are no costs to respondents 

except their time. 

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) 

Adults ages 18 or older .................... National Adult Tobacco Survey ....... 156,000 1 22/60 57,200 

Dated: June 1, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–13301 Filed 6–5–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0251] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; User Fee Cover 

Sheet; Form FDA 3397 

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 

Form FDA 3397, User Fee Cover Sheet, 

that must be submitted along with 

certain drug and biologic product 

applications and supplements. 

DATES: Submit written or electronic 

comments on the collection of 

information by August 7, 2009. 

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 (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794. 

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 

comment 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. 

User Fee Cover Sheet; Form FDA 

3397—(OMB Control Number 0910– 

0297)—Extension 

Under sections 735 and 736 of the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) (21 U.S.C. 379g and 

379h), the Prescription Drug User Fee 

Act of 1992 (PDUFA) (Public Law 102– 

571), as amended by the Food and Drug 

Administration Modernization Act of 

1997 (Public Law 105–115), the Public 

Health Security and Bioterrorism 

Preparedness and Response Act of 2002, 

which includes the Prescription Drug 

User Fee Amendments of 2002 (Public 

Law 107–188), and most recently by the 

Food and Drug Administration 


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