Appendix B - 60 Day FRN

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
Average
burden per
response
(in hours)

Number of
responses per
respondent

Total burden
(in hours)

Form name

NPCR Registries ............................

Workload Management Survey .....
Work Activities Journal ..................

46
368

1
1

4
2

184
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

cprice-sewell on PRODPC61 with NOTICES

Number of
respondents

Type of respondents

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

VerDate Nov<24>2008

15:15 Jun 05, 2009

Jkt 217001

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
[email protected].
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

PO 00000

Frm 00057

Fmt 4703

Sfmt 4703

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

E:\FR\FM\08JNN1.SGM

08JNN1

27145

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

level 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.

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 state-

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.

cprice-sewell on PRODPC61 with NOTICES

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.

VerDate Nov<24>2008

15:15 Jun 05, 2009

Jkt 217001

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

PO 00000

Frm 00058

Fmt 4703

Sfmt 4703

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

E:\FR\FM\08JNN1.SGM

08JNN1