Published 60 Day FRN

828

Federal Register / Vol. 79, No. 4 / Tuesday, January 7, 2014 / Notices

Amarillo and Wichita Falls.
Additionally, for a period of 10 years,
Respondent is required to give the
Commission prior notice of plans to
acquire any interest in a supermarket, or
an interest in a supermarket, that has
operated or is operating in Amarillo and
Wichita Falls.
The sole purpose of this Analysis is
to facilitate public comment on the
proposed Consent Order. This Analysis
does not constitute an official
interpretation of the proposed Consent
Order, nor does it modify its terms in
any way.

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.

By direction of the Commission.
Janice Podoll Frankle,
Acting Secretary.

The Office of Public Health
Preparedness and Response (OPHPR)
provide strategic direction, ongoing
support, and coordination for CDC’s
portfolio of emergency preparedness
and response activities. CDC and
OPHPR work every day to keep America
safe from all-hazards, focusing on
chemical, biological, radiological and
nuclear (CBRN) as well as naturallyoccurring threats, both foreign and
domestic.
OPHPR’s mission is critically
dependent on effectively engaging
outside partners to maximize resources
and overall impact. Therefore, OPHPR
seeks ways to improve its current
partner strategy to engage new partners.
Forging strategic alliances with diverse
stakeholders is critical as OPHPR works
to keep America safe from all health,
safety, and security threats. Health
security is a national challenge that calls
for a national, whole community
solution.
New partners who do not have an
explicit mission statement related to
public health preparedness and
response are difficult to identify;
therefore, OPHPR must use a creative
method that allows groups and
individuals to self-identify their interest
in partnerships—such as an online form
housed on CDC’s public Web site. By
identifying new partners, OPHPR will
strengthen its ability to collaborate with
a broader audience of stakeholders
thereby, strengthening our collective
voice on public health preparedness
issues to keep our nation’s health
secure. OPHPR will use the information
submitted through this online form to
determine who in our agency would be
the best liaison for this potential

[FR Doc. 2013–31224 Filed 1–6–14; 8:45 am]
BILLING CODE 6750–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day-14–14GB]

Proposed Data Collections Submitted
for Public Comment and
Recommendations

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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

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Proposed Project
Become a Partner—New—Office of
Public Health Preparedness and
Response (OPHPR), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description

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partner, and then follow up on this
information with a phone call to further
assess how we can begin building and
effectively managing this new
relationship.
CDC requests Office of Management
and Budget (OMB) approval to collect
information for three years.
Description
The ‘‘Become a Partner’’ template is a
single, double-sided page that will be
used as an online form for anyone
voluntarily exploring how to partner
with OPHPR. This form will
dramatically reduce the burden on
respondents and employees by allowing
self-identification of partnership
interests and collecting information to
determine partnership needs and
opportunities. The questions in the form
specifically request name, address,
phone, email, Web site, and a
combination of five questions related to
partnership interests. The questions
asked will help determine if the
interested party wants to receive
information available through OPHPR, if
they want to exchange information that
is mutually beneficial for crosspromotion, if they coordinate any
activities that support public health
preparedness, and if they offer
additional services to support public
health (not already listed above).
Finally, they will be asked to identify
the most relevant partnership interests
within OPHPR categories.
Ultimately, the form will allow
OPHPR to identify and then engage
interested partners in meaningful
collaborations for the purpose of
expanding, enhancing and sustaining
public health preparedness and
response infrastructure.
We estimate a total of 200 external
governmental and non-governmental
organizational respondents annually.
The ‘‘Become a Partner’’ questionnaire
is estimated to take 15 minutes and the
‘‘Become a Partner’’ follow-up
questionnaire is estimated to take 30
minutes to complete. Therefore, the
total estimated annualized burden for
this information collection is estimated
to be 75 hours.
There are no costs to respondents
other than their time.

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Federal Register / Vol. 79, No. 4 / Tuesday, January 7, 2014 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Avg. burden
per response
(in hrs.)

Total burden
(in hrs.)

Form name

External governmental and non-governmental organizations including non-profit organizations,
trade associations, academic and research institutions, and the private sector.
External governmental and non-governmental organizations including non-profit organizations,
trade associations, academic and research institutions, and the private sector.

Become a Partner ........

100

1

15/60

25

Become a Partner Follow-Up Questions.

100

1

30/60

50

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

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

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

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

75

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.
[FR Doc. 2014–00006 Filed 1–6–14; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–1446]

Self-Monitoring Blood Glucose Test
Systems for Over-the-Counter Use;
Draft Guidance for Industry and Food
and Drug Administration Staff;
Availability
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Self-Monitoring Blood Glucose
Test Systems for Over-the-Counter Use’’.
This draft guidance document describes
studies and criteria FDA recommends in
premarket submissions for selfmonitoring blood glucose test systems
(SMBGs) which are for over-the-counter
(OTC) use by lay-persons. When
finalized, FDA intends for this
document to guide manufacturers in
conducting appropriate performance
studies and preparing premarket
notifications for these device types. This
draft guidance is not final nor is it in
effect at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by April 7, 2014.
SUMMARY:

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responses per
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Number of
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Type of respondents

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Submit written requests for
single copies of the draft guidance
document entitled ‘‘Self-Monitoring
Blood Glucose Test Systems for Overthe-Counter Use’’to the Division of
Small Manufacturers, International, and
Consumer Assistance, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4613,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
request, or fax your request to 301–847–
8149. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the guidance.
Submit electronic comments on the
draft guidance 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:
Patricia Bernhardt, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5654, Silver Spring,
MD 20993–0002, 301–796–6136.
SUPPLEMENTARY INFORMATION:
ADDRESSES:

I. Background
This draft guidance document
describes studies and criteria FDA
recommends for self-monitoring blood
glucose test systems (SMBGs) which are
for over-the-counter (OTC) use by laypersons. When finalized, FDA intends
for this document to guide
manufacturers in conducting
appropriate performance studies and
preparing premarket notifications for
these device types. Portable blood
glucose monitoring systems (also called
glucose meters) that measure blood
glucose concentrations are used by
millions of people with diabetes every
day. These devices are used by patients

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in a variety of settings including in their
homes, at work, and in schools.
Historically, FDA has not
recommended different types of
information in premarket submissions
(510(k)s) for blood glucose monitoring
systems used by medical professionals
as compared to OTC devices intended
for use by lay users. However, it has
become increasingly clear that these
different use settings create distinct
intended use populations with unique
characteristics and device design
requirements. In order to distinguish
between FDA recommendations for
prescription use blood glucose meters,
which are intended for use in point-ofcare professional healthcare settings,
and those intended for OTC selfmonitoring by lay-persons, the Agency
is issuing two separate draft guidances
for (i) prescription use blood glucose
meters, for use in point-of-care
professional healthcare settings, and (ii)
SMBG devices intended for OTC selfmonitoring by lay-persons. FDA
believes that in making this distinction,
SMBG devices can be better designed to
meet the needs of their intended use
populations, thereby ensuring greater
safety and efficacy.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on Self-Monitoring Blood Glucose Test
Systems for Over-the-Counter Use. It
does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statute
and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by using
the Internet. A search capability for all

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