Published 60 Day FRN

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Clostridium difficile Infection (CDI) Surveillance

Published 60 Day FRN

OMB: 0920-0892

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65322

Federal Register / Vol. 78, No. 211 / Thursday, October 31, 2013 / Notices

and Value Research (HSVR) will take
place at: Hyatt Regency Hotel Bethesda,
One Metro Center, Bethesda, MD 20814.
Conference Call of Health Care
Research and Training (HCRT) meeting
will take place at: AHRQ, (Conference
Room TBD), 540 Gaither Road,
Rockville, MD 20850.
(to
obtain a roster of members, agenda or
minutes of the non-confidential portions
of the meetings.)
Mrs. Bonnie Campbell, Committee
Management Officer, Office of
Extramural Research Education and
Priority Populations, AHRQ, 540
Gaither Road, Suite 2000, Rockville,
Maryland 20850, Telephone (301) 427–
1554.

FOR FURTHER INFORMATION CONTACT:

In
accordance with section 10(a)(2) of the
Federal Advisory Committee Act (5
U.S.C. App. 2), AHRQ announces
meetings of the scientific peer review
groups listed above, which are
subcommittees of AHRQ’s Health
Services Research Initial Review Group
Committee. Each subcommittee meeting
will commence in open session before
closing to the public for the duration of
the meeting. The subcommittee
meetings will be closed to the public in
accordance with the provisions set forth
in 5 U.S.C. App. 2 section 10(d), 5
U.S.C. 552b(c)(4), and 5 U.S.C.
552b(c)(6) The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Agenda items for these meetings are
subject to change as priorities dictate.

SUPPLEMENTARY INFORMATION:

Dated: October 24, 3013.
Richard Kronick,
AHRQ Director.
[FR Doc. 2013–25833 Filed 10–30–13; 8:45 am]
BILLING CODE 4160–90–P

Background and Brief Description

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Steady increases in the rate and
severity of Clostridium difficile
infection (CDI) indicate a clear need to
conduct longitudinal assessments to
continue to monitor changes in CDI
epidemiology, including changes in risk
factors for disease, as well as increases
The surveillance population will consist
of persons residing in the catchment
area of the participating Emerging
Infections Program (EIP) sites who are 1
year of age or older. This surveillance
poses no more than minimal risk to the
study participants as there will be no
interventions or modifications to the
care study participants receive. EIP
surveillance personnel will perform
active case finding from laboratory
reports of stool specimens testing
positive for C. difficile toxin and
abstract data on cases using a
standardized case report form. For a
subset of cases (e.g., communityassociated C. difficile cases) sites will
administer a health interview.
CDC requests Office of Management
and Budget (OMB) extension of
standardized data collection for an
additional three years. The
epidemiology of C. difficile continues to
evolve and incidence of disease is still
high with no significant declines being
observed. Continuing to understand
what put persons at risk for C. difficile
in the community is critical to inform
prevention strategies. There are no
changes in the burden estimates or data
collection instruments from what is
shown in the current inventory.
A total of 600 individuals who
develop CDI will be contacted for a
telephone interview annually and of
those it is estimated that 500 will meet
study inclusion criteria. The interview
screening is estimated to take 5 minutes
and the full telephone interview is
estimated to take 40 minutes. Therefore,
the total estimated annualized burden
for this data collection is estimated to be
383 hours.
There are no costs to the respondents
other than their time.

Centers for Disease Control and
Prevention
[60Day–14–0892]

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 404–639–7570 or send
comments to LeRoy Richardson, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an email 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
Clostridium difficile Infection (CDI)
Surveillance (0920–0892, Expiration
07/31/2014)—Extension—National
Center for Emerging and Zoonotic
Infectious Diseases (NCEZID), Centers
for Disease Control and Prevention
(CDC).

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ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Number of
responses per
respondent

Avg. burden
per response
(in hrs.)

Total burden
(in hrs.)

Type of respondents

Form name

Persons in the community infected
with C. difficile.

Screening Form ................................

600

1

5/60

50

Telephone Interview .........................

500

1

40/60

333

...........................................................

........................

........................

........................

383

Total ...........................................

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Federal Register / Vol. 78, No. 211 / Thursday, October 31, 2013 / Notices
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2013–25862 Filed 10–30–13; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention

appropriate) discussing the health
effects of these ingredients.
HHS has delegated responsibility for
implementing the required information
collection to CDC’s Office on Smoking
and Health. Respondents are not
required to submit specific forms;
however, they are required to meet
reporting guidelines and to submit the
ingredient report by chemical name and
Chemical Abstract Service (CAS)
Registration Number, consistent with
accepted reporting practices for other
companies that are required to report
ingredients added to other consumer
products. Typically, respondents submit
a summary report to CDC with the
ingredient information for multiple
products, or a statement that there are
no changes to their previously
submitted ingredient report.
Respondents may submit the required
information to CDC through a
designated representative. The
information collection is subject to strict
confidentiality provisions.
Ingredient reports for new SLT
products are due at the time of first
importation. Thereafter, ingredient
reports are due annually on March 31.
Information is submitted to OSH by
mailing a written report on the
respondent’s letterhead, which may be
accompanied by a Compact Disc (CD),
three-inch floppy disk, or thumb drive.
Electronic mail submissions are not
accepted. Annual submission reports
are mailed to: Office on Smoking and
Health, Attention: FCLAA Program
Manager, National Center for Chronic
Disease Prevention and Health
Promotion, Centers for Disease Control
and Prevention, 4770 Buford Highway
NE., MS F–79, Atlanta, GA 30341–3717.
Upon receipt and verification of the
annual nicotine and ingredient report,
OSH issues a Certificate of Compliance
to the respondent.
There are no costs to respondents
other than their time. Office of
Management and Budget (OMB)
approval is requested for three years.

Proposed Project
Annual Submission of the Ingredients
Added to, and the Quantity of Nicotine
Contained in, Smokeless Tobacco
Manufactured, Imported, or Packaged in
the U.S. (OMB No. 0920–0338, exp.
02/28/2014)—Extension—Office on
Smoking and Health, National Center
for Chronic Disease Prevention and
Health Promotion (NCCDPHP), Centers
for Disease Control and Prevention
(CDC).
Background and Brief Description

[60Day–14–0338)

Agency Forms Undergoing Paperwork
Reduction Act Review
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 404–639–7570 or send
comments to CDC, LeRoy Richardson,
1600 Clifton Road, MS D–74, Atlanta,
GA 30333 or send an email 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.

65323

The oral use of smokeless tobacco
(SLT) products represents a significant
health risk. Smokeless tobacco products
contain carcinogens which can cause
cancer and a number of non-cancerous
oral conditions, as well as leading to
nicotine addiction and dependence.
Furthermore, SLT use is not a safe
substitute for cigarette smoking.
Adolescents who use smokeless tobacco
are more likely to become cigarette
smokers.
The Centers for Disease Control and
Prevention (CDC), Office on Smoking
and Health (OSH), has primary
responsibility for the Department of
Health and Human Services (HHS)
smoking and health program. HHS’s
overall goal is to reduce death and
disability resulting from the use of
smokeless tobacco products and other
forms of tobacco through programs of
information, education and research.
The Comprehensive Smokeless
Tobacco Health Education Act of 1986
(CSTHEA, 15 U.S.C. 4401 et seq., Pub.
L. 99–252) requires each person who
manufactures, packages, or imports
smokeless tobacco products to provide
the Secretary of HHS with a list of
ingredients added to tobacco in the
manufacture of smokeless tobacco
products. CSTHEA further requires
submission of the quantity of nicotine
contained in each smokeless tobacco
product. Finally, the legislation
authorizes HHS to undertake research,
and to report to Congress (as deemed

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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)

Smokeless Tobacco Manufacturers,
Packagers, and Importers.

SLT Nicotine and Ingredient Report

13

1

1,713

22,269

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File Created2013-10-31

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