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Federal Register / Vol. 78, No. 172 / Thursday, September 5, 2013 / Notices
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
Evaluation of Food Safety Programs—
New—National Center for
Environmental Health (NCEH), Centers
for Disease Control and Prevention
(CDC).
Background and Brief Description
Local and state food safety programs
(FSPs) are on the frontline of foodborne
disease prevention in the U.S. Through
the Environmental Health Specialists
Network (EHS-Net), CDC currently
funds and works with local and state

capacity and competency, financial
resources, community health, and
demographics of FSPs. Data collected
will help CDC better understand the
relationship between different levels of
funding and FSP effectiveness in the
U.S.
The evaluation survey will take
approximately two hours to complete.
The survey will be completed once by
respondents either manually or
electronically. The CDC is asking for
this data collection burden to allow
local and state health departments
ample time to request and obtain the
information they need from their
various departments and units to
complete the evaluation survey.
There are over 3,000 state and local
health departments in the U.S. It is
unknown how many state and local
health departments will actually
participate in the evaluation survey, as
participation will be voluntary. Per year,
the anticipated number of respondents
for this survey is 190 health
departments, and the requested number
of burden hours is 380. The CDC is
requesting OMB approval for two years.
Only local and state health
departments implementing food safety
programs in the U.S. will be eligible to
participate in the survey. There will be
no cost to the respondents other than
their time.

health departments in five states
(California, New York, Minnesota,
Rhode Island, and Tennessee) to: (1)
Identify environmental antecedents
(underlying factors) to illness and
disease outbreaks; (2) translate findings
into improved prevention efforts using a
systems-based approach; (3) offer
training opportunities to current and
future environmental health specialists;
and (4) strengthen collaboration among
epidemiology, laboratory, and
environmental health programs. This
CDC program offers insights into the
current status of FSPs among EHS-Net
partners, but information is lacking on
a national scale.
In the current economic milieu, food
safety, along with other public health
programs, is being eliminated due to
funding reductions. Therefore, the CDC
proposes to conduct the ‘‘Evaluation of
Food Safety Programs’’ survey among a
representative sample of local and state
health departments implementing FSPs
in the United States (U.S.).
The purpose of this evaluation of
local and state FSPs is to collect
descriptive data on the current status
and activities, to describe changes in
status and activities from 2007 to 2012,
and to determine if there is a
relationship between funding and status
and activities. Data will be collected on
food safety activities, workforce

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents

Local health departments .................
State health departments ..................
Total ...........................................

Evaluation
Evaluation
Evaluation
Evaluation

Survey
Survey
Survey
Survey

Total burden
(in hrs.)

1
1
1
1

2
2
2
2

276
70
28
6

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

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

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

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

380

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

[FR Doc. 2013–21543 Filed 9–4–13; 8:45 am]

[60Day-13–13AHL]

Centers for Disease Control and
Prevention

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

14:10 Sep 04, 2013

Average
burden per
response
(in hrs.)

138
35
14
3

Leroy 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.

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responses per
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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 D–74, 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

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54654

Federal Register / Vol. 78, No. 172 / Thursday, September 5, 2013 / Notices

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
Colorectal Cancer Screening Survey—
New—National Center for Chronic
Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Unhealthy behaviors contribute to a
significant public health gap in terms of
eliminating preventable deaths. This
gap disproportionately affects lowincome, minority, uninsured or underinsured populations and stems in part
from a failure to receive basic clinical
preventative services such as cancer
screening, as well as risk factors such as
obesity, physical inactivity, excessive
alcohol consumption and tobacco use.
The challenge for public health is to
identify the social interventions or
mechanisms that might be effective in
reaching members of the public who do
not respond to traditional public health
messages and interventions designed to
support healthy behaviors. An improved
understanding of the determinants of
individual decision-making and
behavior is needed to identify
opportunities for strengthening public
health interventions.
The Centers for Disease Control (CDC)
plans to conduct a study to improve

understanding of the reasons that
individuals do not get screened for
colorectal cancer (CRC). CRC is the
second leading cause of cancer related
death in the U.S., and screening for CRC
is recommended for adults starting at
age 50. Screening for CRC can prevent
deaths by removing pre-cancerous
polyps and finding cancer early when it
is most treatable. However, as of 2008,
only 62.9% of adults aged 50–75 years
were screened as recommended.
CDC will request OMB approval to
administer a survey to collect
information on actual screening
behavior, subjective and objective colon
cancer risk perceptions, and barriers to
screening. The survey is also designed
to measure preferences for different
characteristics of CRC screening tests.
Information collection will involve a
Web-based survey based on a conjoint
analysis approach (also known as
discrete choice experiment). The
conjoint format presents respondents
with choices between hypothetical CRC
tests that vary along key attributes. The
six attributes that will be assessed for
CRC screening tests are: (1) What the
test can find, (2) whether the test can
remove cancer and polyps, (3)
preparation before the test, (4)
discomfort and activity limitations
during and after the test, (5) how often
an individual can take the test, and 6)
cost of the test. Results will be analyzed
to quantify the rate at which
respondents are willing to trade-off one
attribute for another and to rank the
importance of attributes and changes in
attribute levels.

The survey will also collect
information to measure the impact of
selected educational materials on
opinions about CRC screening tests.
Each respondent will be randomly
assigned to one of three information
treatments: (1) A control group that
receives no additional information
about CRC screening, (2) a treatment
group that receives a ‘‘No Excuses’’
educational flyer designed to dispel
many common reasons for not getting a
colonoscopy, or (3) a treatment group
that receives a two-page Fact Sheet
about CRC and screening options. The
flyer and fact sheet were developed in
conjunction with CDC’s Screen for Life
program.
Information will be collected from a
sample of 2,000 adults aged 52–75
through a Web-based survey
administered by GfK Knowledge
Networks (KN). The estimated burden
per response is 20 minutes.
Respondents will be randomly selected
from the KN KnowledgePanel. A pretest of study procedures will be
conducted prior to initiating the main
study.
CDC is authorized to conduct this
information collection under the Public
Health Service Act (42 U.S.C. 241)
Section 301. Results will be used to help
CDC better understand public
perceptions of screening tests and to
improve rates of CRC screening among
individuals at risk.
OMB approval is requested for one
year. Participation is voluntary and
there are no costs to respondents other
than their time.

ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Pre-Test Participants ............

Email Invitation .....................
Survey of Preferences for
Colorectal Cancer Screening.
Email Invitation .....................
Survey of Preferences for
Colorectal Cancer Screening.

Study Participants .................

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Number of
respondents

Type of respondents

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per response
(in hr)

Total burden
(in hr)

43
30

1
..............................

2/60
20/60

1
10

2,680
2,000

1
1

2/60
20/60

89
667

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767

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Federal Register / Vol. 78, No. 172 / Thursday, September 5, 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. 2013–21604 Filed 9–4–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0477]

Center for Devices and Radiological
Health: Draft Standard Operating
Procedure for Level 1, Immediately in
Effect Guidance Documents on
Premarket Data Issues; Availability and
Request for Comments
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice; request for comments.

The Food and Drug
Administration (FDA) is announcing the
availability of the Draft Standard
Operating Procedure (SOP) for Level 1,
Immediately in Effect (IIE) Guidance
Documents on Premarket Data Issues.
The SOP describes the Center for
Devices and Radiological Health’s
(CDRH’s or the Center’s) draft process to
clarify and more quickly inform
stakeholders when CDRH has changed
its expectations relating to, or otherwise
has new scientific information that
could affect, data submitted as part of an
Investigational Device Exemption (IDE)
or premarket submission, including a
Premarket Notification 510(k), a
Premarket Approval (PMA), or a
Humanitarian Device Exemption (HDE)
that needs to be disseminated in a
timely manner.
DATES: The Agency encourages
interested parties to submit information
and either electronic or written
comments by October 21, 2013.
ADDRESSES: See the SUPPLEMENTARY
INFORMATION section for electronic
access to the document. Submit
electronic comments on the draft SOP to
http://www.regulations.gov. Submit
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Identify comments with the docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Philip Desjardins, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5452, Silver Spring,

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SUMMARY:

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MD 20993–0002, 301–796–5678,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The Task Force on the Utilization of
Science in Regulatory Decision Making
(the Task Force) published a
Preliminary Report and
Recommendations in August 2010. In
the report, the Task Force noted that
when new scientific information
changes CDRH’s regulatory thinking, it
has been challenging for the Center to
communicate the change and its basis to
all affected parties in a meaningful and
timely manner. The Task Force
recommended that the Center make use
of more rapid tools for broad
communication on regulatory matters,
including establishing a standard
practice for communicating to all
manufacturers of a particular group of
devices for which the Center has
changed its regulatory expectations on
the basis of new scientific information.
Currently, manufacturers typically
learn of changes CDRH implements
regarding what data or how to gather
specific data in support of an IDE or
premarket submission, including a
Premarket Notification 510(k), a PMA,
or an HDE at the time of or soon after
a decision is made through individual
engagement with the Center, often not
until after they have prepared that
submission. Reviewers may implement
these changes, such as requesting new
clinical data or using a new test method,
on a case-by-case basis, with immediate
supervisory concurrence when it is
necessary to protect the public health.
For example, a reviewer may request
that sponsors test their implantable
device for durability because new data
demonstrate that this type of device is
prone to failure due to premature wear
and tear of the technology. Although
CDRH may issue a detailed guidance
document, the document may not be
published until a year or more after a
Branch- or Division-level decision has
been made to request the information
because of the resource constraints in
developing guidance documents.
CDRH believes that timely
communication with industry about
changes in premarket regulatory
expectations is important. FDA’s Good
Guidance Practices regulation provides
a mechanism for communicating and
implementing certain changes in
regulatory expectations quickly, without
requiring prior public comment. Under
21 CFR 10.115(g)(2), FDA may issue a
Level 1, IIE Guidance Document when
prior public participation is not
‘‘feasible or appropriate.’’ Under these
circumstances, CDRH intends to use the

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54655

procedures described in § 10.115(g)(2) to
issue guidance documents addressing
changes in premarket regulatory
expectations. CDRH has developed this
SOP to facilitate issuance of such
guidance documents.
On July 21, 2011 (76 FR 43693),
CDRH issued a Standard Operating
Procedure for ‘‘Notice to Industry’’
Letters, which outlined a similar
process to clarify and quickly inform
stakeholders of new CDRH expectations
(http://www.fda.gov/downloads/
MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/UCM259172.pdf).
After considering the comments
received on that proposal, CDRH is now
announcing a draft SOP that meets the
Center’s needs and addresses concerns
raised regarding the original ‘‘Notice to
Industry’’ proposal.
II. Electronic Access
Persons interested in obtaining a copy
of the draft SOP may do so by using the
Internet. The Draft Standard Operating
Procedure for Level 1, Immediately in
Effect Guidance Documents on
Premarket Data Issues is available at
http://www.fda.gov/downloads/
MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/UCM259172.pdf.
The draft SOP is also available from
http://www.regulations.gov and can be
located using the docket number found
in brackets in the heading of this
document.
III. Comments
Interested persons may submit either
electronic comments regarding this
document to http://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at http://
www.regulations.gov.
Dated: August 28, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–21544 Filed 9–4–13; 8:45 am]
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