Submission for OMB Review; 30-Day Comment Request; The National Diabetes Education Program (NDEP) Comprehensive Evaluation Plan, 49784-49785 [2014-19971]
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49784
Federal Register / Vol. 79, No. 163 / Friday, August 22, 2014 / Notices
tkelley on DSK3SPTVN1PROD with NOTICES
also be Webcast. Persons interested in
viewing the Webcast must register
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Organizations are requested to register
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go/connectpro_overview. (FDA has
verified the Web site addresses in this
document, but FDA is not responsible
for any subsequent changes to the Web
sites after this document publishes in
the Federal Register.)
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. A transcript
will also be available in either hardcopy
or on CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to the Division
of Freedom of Information (ELEM–
1029), Food and Drug Administration,
12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857. A link to the
transcript will also be available
approximately 45 days after the public
workshop on the Internet at https://
www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm. (Select this public
workshop from the posted events list).
Supplementary information:
I. Background
To ensure that safe and effective
contact lenses and associated care
products are introduced into the U.S.
marketplace, FDA has issued guidance
documents, recognized standards that
describe the appropriate test methods,
and held workshops. In 2009, FDA held
a workshop entitled ‘‘Microbiological
Testing for Contact Lens Care Products’’
that was cosponsored by AAO, AAOpt,
AOA, and CLAO (Ref. 1).
Representatives from industry,
academia, professional organizations,
and regulatory agencies discussed
variables to consider when developing
disinfection efficacy test methods
against Acanthamoeba keratitis (AK) as
well as current contact lens disinfection
tests and limitations.
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16:23 Aug 21, 2014
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Although the 2009 workshop began
gathering information, there has been a
persistent increase in the number of AK
cases (Ref. 2). This persistent rise in the
number of AK cases has prompted
concern about the safety of contact lens
care products. While most experts
present at a 2008 Ophthalmic Devices
Advisory Panel meeting agreed that
Acanthamoeba should be added as a
challenge organism to disinfection
efficacy testing methods, consensus has
not been reached on the appropriate
method for performing this testing (Ref.
3).
At this workshop, the concerning rise
in the keratitis associated with
Acanthamoeba will be discussed as
well as the emergence of other
pathogens in contact lens related
keratitis. The progress made in the
development of Acanthamoeba test
methods will be summarized. The goal
of the workshop is to determine uniform
testing methods for Acanthamoeba
disinfection efficacy as well as to
discuss methods for conducting realworld simulated testing of contact lens
care products. The meeting will bring
together scientists, clinicians, and
industry experts to discuss critical
aspects of disinfection efficacy testing.
The FDA/AAO/AAOpt/AOA/CLAO
Workshop will provide FDA with an
important opportunity to interact with
stakeholders and gain knowledge and
information on methods to test
commonly used medical devices and
would assist the Agency in carrying out
its mission to promote and protect the
public health.
II. Topics for Discussion at the Public
Workshop
Topics to be discussed at the public
workshop include, but are not limited
to, the following as they relate to contact
lenses and their associated care
products:
• Emerging infectious pathogens in
contact lens related keratitis;
• role of soil in disinfection efficacy
testing; and
• Acanthamoeba disinfection efficacy
test methods.
These topics will be presented by
experts in the associated area with more
in-depth discussions of the given topics
during panel sessions.
III. References
The following references have been
placed on display in the Division of
Dockets Management (see Transcripts)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday, and are available
electronically at https://
www.regulations.gov. (FDA has verified
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the Web site addresses in this reference
section, but FDA is not responsible for
any subsequent changes to the Web sites
after this document publishes in the
Federal Register.)
1. Public workshop in 2009,
‘‘Microbiological Testing for Contact Lens
Care Products,’’ Federal Register notice,
available at https://www.gpo.gov/fdsys/pkg/
FR-2008-12-16/pdf/E8-29741.pdf.
2. Yoder, J.S. et al., ‘‘Acanthamoeba
Keratitis: The Persistence of Cases Following
a Multistate Outbreak,’’ Ophthalmic
Epidemiology, vol. 19, pp. 221–225, 2012.
3. Ophthalmic Devices Advisory Panel
meeting (2008) minutes, available at https://
www.fda.gov/ohrms/dockets/ac/08/minutes/
2008-4363m1.pdf.
Dated: August 19, 2014.
Peter Lurie,
Associate Commissioner for Policy and
Planning.
[FR Doc. 2014–19938 Filed 8–21–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; The National
Diabetes Education Program (NDEP)
Comprehensive Evaluation Plan
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institute of Diabetes and Digestive and
Kidney Diseases (NIDDK), the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on March 19, 2014,
pages 15351 and 15351 [FR DOC #:
2014–06064], and allowed 60 days for
public comment. There was 1 public
comment received. The purpose of this
notice is to allow an additional 30 days
for public comment. The National
Institutes of Health may not conduct or
sponsor, and the respondent is not
required to respond to, an information
collection that has been extended,
revised, or implemented on or after
October 1, 1995, unless it displays a
currently valid OMB control number.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, OIRA_submission@
SUMMARY:
E:\FR\FM\22AUN1.SGM
22AUN1
Federal Register / Vol. 79, No. 163 / Friday, August 22, 2014 / Notices
omb.eop.gov or by fax to 202–395–6974,
Attention: NIH Desk Officer.
DATES: Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments or request more
information on the proposed project
contact: Ms. Joanne Gallivan, M.S., R.D.,
Director, National Diabetes Education
Program, OCPL, NIDDK, 31 Center
Drive, MSC 2560, Bethesda, MD 20892,
or call non-toll-free number 301–496–
6110, or Email your request, including
your address to: joanne_gallivan@
nih.gov. Formal requests for additional
plans and instruments must be
requested in writing.
Proposed Collection: The National
Diabetes Education Program (NDEP)
Comprehensive Evaluation Plan, 0925–
0552, Expiration Date 10/31/2015,
REVISION, National Institute of
Diabetes and Digestive and Kidney
Disease (NIDDK), National Institutes of
Health (NIH).
49785
primary data from NDEP target
audiences on some key process and
impact measures that are necessary to
effectively evaluate the program. The
audiences targeted by the NDEP include
people at risk for diabetes, people with
diabetes and their families, and the
public.
OMB approval is requested for
changing the data collection
methodology from a random-digitdialing (RDD) telephone survey to a
probability-based web-based survey as
well as an update of the survey
questionnaire which has not been
updated since it was first developed in
2006. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
833. This represents a modest increase
in the burden amount from the
previously approved 749 hours to 833
hours, an additional 84 hours overall.
This burden reflects an increase of 5
minutes per participant due to survey
content changes and an additional 400
participants.
Need and Use of Information
Collection: The National Diabetes
Education Program (NDEP) is a
partnership of the National Institutes of
Health (NIH) and the Centers for Disease
Control and Prevention (CDC) and more
than 200 public and private
organizations. The long-term goal of the
NDEP is to reduce the burden of
diabetes and pre-diabetes in the United
States, and its territories, by facilitating
the adoption of proven strategies to
prevent or delay the onset of diabetes
and its complications.
The NDEP evaluation will document
the extent to which the NDEP program
has been implemented and how
successful it has been in meeting
program objectives, outlined in the
NDEP Strategic Plan. The evaluation
relies heavily on data gathered from
existing national surveys such as
National Health and Nutrition
Examination Survey (NHANES), the
National Health Interview Survey
(NHIS), the Behavioral Risk Factor
Surveillance System (BRFSS), among
others for this information. This is a
continued collection of additional
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent and
instrument
Estimated
number of
respondents
Estimated
number of
responses per
respondent
Average time
per response
(in hours)
Estimated
total annual
burden hours
Adults—Survey instrument ..............................................................................
2,500
1
20/60
833
Dated: July 14, 2014.
Frank Holloman,
Project Clearance Liaison, NIDDK, NIH.
[FR Doc. 2014–19971 Filed 8–21–14; 8:45 am]
Dated: August 19, 2014.
Michelle Trout,
Program Analyst, Office of the Federal
Advisory Committee Policy.
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
BILLING CODE 4140–01–P
[FR Doc. 2014–20024 Filed 8–21–14; 8:45 am]
Name of Committee: National Institute on
Deafness and Other Communication
Disorders Special Emphasis Panel;
Translational Research R01 Applications in
Hearing and Balance.
Date: September 11, 2014.
Time: 12:30 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Kausik Ray, Ph.D.,
Scientific Review Officer, National Institute
on Deafness and Other Communication
Disorders, National Institutes of Health,
Rockville, MD 20850, 301–402–3587, rayk@
nidcd.nih.gov.
Name of Committee: National Institute on
Deafness and Other Communication
Disorders Special Emphasis Panel;
Communication Disorders Clinical Trial
Review.
Date: September 17, 2014.
Time: 10:00 a.m. to 12:00 p.m.
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Library of Medicine Notice of
Meetings Amended Notice of Meeting
tkelley on DSK3SPTVN1PROD with NOTICES
National Institutes of Health
National Institute on Deafness and
Other Communication Disorders;
Notice of Closed Meetings
Notice is hereby given of a change in
the meeting of the Special Emphasis
Panel, October 15–16, 2014, 9:00 a.m. to
6:00 p.m., National Library of Medicine,
6705 Rockledge Drive, Suite 301,
Bethesda, MD 20817 which was
published in the Federal Register on
June 9, 2014, 79 FR 110, Page 32969.
The meeting of the Special Emphasis
Panel will be held on October 23–24,
2014 instead of October 15–16, 2014, at
9:00 a.m. and will end at 6:00 p.m. The
meeting is closed to the public.
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16:23 Aug 21, 2014
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Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
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]]>Agencies
[Federal Register Volume 79, Number 163 (Friday, August 22, 2014)]
[Notices]
[Pages 49784-49785]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-19971]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request; The National
Diabetes Education Program (NDEP) Comprehensive Evaluation Plan
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institute of Diabetes and Digestive
and Kidney Diseases (NIDDK), the National Institutes of Health (NIH)
has submitted to the Office of Management and Budget (OMB) a request
for review and approval of the information collection listed below.
This proposed information collection was previously published in the
Federal Register on March 19, 2014, pages 15351 and 15351 [FR DOC
: 2014-06064], and allowed 60 days for public comment. There
was 1 public comment received. The purpose of this notice is to allow
an additional 30 days for public comment. The National Institutes of
Health may not conduct or sponsor, and the respondent is not required
to respond to, an information collection that has been extended,
revised, or implemented on or after October 1, 1995, unless it displays
a currently valid OMB control number.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, OIRA--submission@
[[Page 49785]]
omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer.
DATES: Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30-days
of the date of this publication.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments or request more information on the
proposed project contact: Ms. Joanne Gallivan, M.S., R.D., Director,
National Diabetes Education Program, OCPL, NIDDK, 31 Center Drive, MSC
2560, Bethesda, MD 20892, or call non-toll-free number 301-496-6110, or
Email your request, including your address to: joanne_gallivan@nih.gov. Formal requests for additional plans and instruments
must be requested in writing.
Proposed Collection: The National Diabetes Education Program (NDEP)
Comprehensive Evaluation Plan, 0925-0552, Expiration Date 10/31/2015,
REVISION, National Institute of Diabetes and Digestive and Kidney
Disease (NIDDK), National Institutes of Health (NIH).
Need and Use of Information Collection: The National Diabetes
Education Program (NDEP) is a partnership of the National Institutes of
Health (NIH) and the Centers for Disease Control and Prevention (CDC)
and more than 200 public and private organizations. The long-term goal
of the NDEP is to reduce the burden of diabetes and pre-diabetes in the
United States, and its territories, by facilitating the adoption of
proven strategies to prevent or delay the onset of diabetes and its
complications.
The NDEP evaluation will document the extent to which the NDEP
program has been implemented and how successful it has been in meeting
program objectives, outlined in the NDEP Strategic Plan. The evaluation
relies heavily on data gathered from existing national surveys such as
National Health and Nutrition Examination Survey (NHANES), the National
Health Interview Survey (NHIS), the Behavioral Risk Factor Surveillance
System (BRFSS), among others for this information. This is a continued
collection of additional primary data from NDEP target audiences on
some key process and impact measures that are necessary to effectively
evaluate the program. The audiences targeted by the NDEP include people
at risk for diabetes, people with diabetes and their families, and the
public.
OMB approval is requested for changing the data collection
methodology from a random-digit-dialing (RDD) telephone survey to a
probability-based web-based survey as well as an update of the survey
questionnaire which has not been updated since it was first developed
in 2006. There are no costs to respondents other than their time. The
total estimated annualized burden hours are 833. This represents a
modest increase in the burden amount from the previously approved 749
hours to 833 hours, an additional 84 hours overall. This burden
reflects an increase of 5 minutes per participant due to survey content
changes and an additional 400 participants.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Estimated
Estimated number of Average time Estimated
Type of respondent and instrument number of responses per per response total annual
respondents respondent (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
Adults--Survey instrument................... 2,500 1 20/60 833
----------------------------------------------------------------------------------------------------------------
Dated: July 14, 2014.
Frank Holloman,
Project Clearance Liaison, NIDDK, NIH.
[FR Doc. 2014-19971 Filed 8-21-14; 8:45 am]
BILLING CODE 4140-01-P
