Proposed Collection; Comment Request; the National Diabetes Education Program Comprehensive Evaluation Plan, 52052-52053 [E8-20636]
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Federal Register / Vol. 73, No. 174 / Monday, September 8, 2008 / Notices
Successor organization; a discussion on
the health information technology
Strategic Plan; and final reports from the
Confidentiality, Privacy & Security
Workgroup and the Population Health/
Clinical Care Connections Workgroup.
FOR FURTHER INFORMATION: Visit https://
www.hhs.gov/healthit/ahic.html.
A Web cast of the Community
meeting will be available on the NIH
Web site at: https://
www.videocast.nih.gov/.
If you have special needs for the
meeting, please contact (202) 690–7151.
Dated: August 26, 2008.
Judith Sparrow,
Director, American Health Information
Community, Office of Programs and
Coordination, Office of the National
Coordinator for Health Information
Technology.
[FR Doc. E8–20675 Filed 9–5–08; 8:45 am]
BILLING CODE 4150–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0038]
FDA Clinical Trial Requirements
Regulations, Compliance, and Good
Clinical Practice Conference; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA) Dallas District, in
cooperation with the Society of Clinical
Research Associates(SoCRA), is
announcing a workshop on FDA
Clinical Trial statutory and regulatory
requirements. This 2-day workshop for
the clinical research community targets
sponsors, monitors, clinical
investigators, institutional review
boards, and those who interact with
them for the purpose of conducting FDA
regulated clinical research. The
workshop will include both industry
and FDA perspectives on proper
conduct of clinical trials regulated by
FDA.
Date and Time: The public workshop
is scheduled for Wednesday, November
19, 2008, from 8 a.m. to 5 p.m. and
Thursday, November 20, 2008, from 8
a.m. to 5 p.m.
Location: The public workshop will
be held at the Westin Crown Center, 1
East Pershing Rd., Kansas City, MO
64118, 816–474–4400, FAX: 816–391–
4438.
Contact: David Arvelo, Food and Drug
Administration, 4040 N. Central
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SUMMARY:
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17:59 Sep 05, 2008
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Expressway, suite 900, Dallas, TX
75204, 214–253–4952, FAX: 214–253–
4970, e-mail: david.arvelo@fda.hhs.gov.
Registration: Send registration
information (including name, title, firm
name, address, telephone, and fax
number) and the registration fee of $575
(member), $650 (nonmember), $525
(government employee nonmember), or
$450 (government employee member).
(Registration fee for nonmembers
includes a 1-year membership.) The
registration fee for FDA employees is
waived. Make the registration fee
payable to SoCRA, 530 West Butler
Ave., suite 109, Chalfont, PA 18914. To
register via the Internet go to https://
www.socra.org/html/
FDA_Conference.htm (FDA has verified
the Web site address, but is not
responsible for subsequent changes to
the Web site after this document
publishes in the Federal Register.) The
registrar will also accept payment by
major credit cards. For more
information on the meeting, or for
questions on registration, contact 800–
SoCRA92 (800–762–7292), or 215–822–
8644, or via e-mail: socramail@aol.com.
Attendees are responsible for their own
accommodations. To make reservations
at the Westin Crown Center at the
reduced conference rate, contact the
Westin Crown Center (see Location)
before October 21, 2008. The
registration fee will be used to offset the
expenses of hosting the conference,
including meals, refreshments, meeting
rooms, and materials. Space is limited;
therefore interested parties are
encouraged to register early. Limited
onsite registration may be available.
Please arrive early to ensure prompt
registration. If you need special
accommodations due to a disability,
please contact David Arvelo (see
Contact) at least 21 days in advance of
the workshop.
SUPPLEMENTARY INFORMATION: The FDA
Clinical Trial Requirements Regulations,
Compliance, and GCP Conference, helps
fulfill the Department of Health and
Human Services’ and FDA’s important
mission to protect the public health by
educating researchers on proper
conduct of clinical trials. Topics for
discussion include the following: (1)
FDA and confidence in the conduct of
clinical research; (2) medical device,
drug, biological product, and food
additive aspects of clinical research; (3)
investigator initiated research; (4) Preinvestigational new drug (IND)
application meetings and FDA meeting
process; (5) informed consent
requirements; (6) ethics in subject
enrollment; (7) FDA regulation of
Institutional Review Boards; (8)
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electronic records requirements; (9)
adverse event reporting; (10) how FDA
conducts bioresearch inspections, and
(11) what happens after the FDA
inspection. FDA has made education of
the research community a high priority
to assure the quality of clinical data and
protect research subjects. The workshop
helps to implement the objectives of
section 406 of the FDA Modernization
Act (21 U.S.C. 393) and the FDA Plan
for Statutory Compliance, which
includes working more closely with
stakeholders and ensuring access to
needed scientific and technical
expertise. The workshop also furthers
the goals of the Small Business
Regulatory Enforcement Fairness Act
(Public Law 104–121) by providing
outreach activities by Government
agencies directed to small businesses.
Dated: September 2, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–20730 Filed 9–5–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; the National Diabetes
Education Program Comprehensive
Evaluation Plan
SUMMARY: 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
National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK),
the National Institutes of Health (NIH)
will publish periodic summaries of
proposed projects to be submitted to the
Office of Management and Budget
(OMB) for review and approval.
Proposed Collection: Title: The
National Diabetes Education Program
Comprehensive Evaluation Plan. Type
of Information Collection Request:
Extension of a currently approved
collection (#0925–0552). 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 goals of
the NDEP are to: Improve the treatment
and health outcomes of people with
diabetes, promote early diagnosis, and,
ultimately, prevent the onset of
diabetes. The NDEP objectives are: (1)
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Federal Register / Vol. 73, No. 174 / Monday, September 8, 2008 / Notices
To increase awareness of the
seriousness of diabetes, its risk factors,
and strategies for preventing diabetes
and its complications among people at
risk for diabetes; (2) to improve
understanding about diabetes and its
control and to promote better selfmanagement behaviors among people
with diabetes; (3) to improve health care
providers’ understanding of diabetes
and its control and to promote an
integrated approach to care; (4) to
promote health care policies that
improve the quality of and access to
diabetes care.
Multiple strategies have been devised
to address the NDEP objectives. These
have been described in the NDEP
Strategic Plan and include: (1) Creating
partnerships with other organizations
concerned about diabetes; (2)
developing and implementing
awareness and education activities with
special emphasis on reaching the racial
and ethnic populations
disproportionately affected by diabetes;
(3) identifying, developing, and
disseminating educational tools and
resources for the program’s diverse
audiences; (4) promoting policies and
activities to improve the quality of and
access to diabetes care.
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. 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 generic
clearance request is for the collection of
additional primary data from NDEP
target audiences on some key process
and impact measures that are necessary
to effectively evaluate the program.
Approval is requested for a survey of
audiences targeted by the National
Diabetes Education Program including
people at risk for diabetes, people with
diabetes and their families and the
public.
Frequency of Response: On occasion.
Affected Public: Individuals or
households. Type of Respondents:
Adults. The annual reporting burden is
as follows: Estimated Number of
Respondents: 3759, Estimated Number
of Responses per Respondent: 1;
Average Burden Hours per Response:
.153; and Estimated Total Annual
Burden Hours Requested: 575. There are
no Capital, Operating or Maintenance
Costs to report.
ESTIMATES OF HOUR BURDEN
Average
time per
response
Number of
respondents
Frequency
of response
Screening interview with ineligible persons .....................................................................
Eligible respondents ........................................................................................................
1659
2100
1
1
.03
.25
50
525
Totals ........................................................................................................................
3759
....................
....................
575
Type of respondents
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’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 those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
mstockstill on PROD1PC66 with NOTICES
FOR FURTHER INFORMATION CONTACT:
To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Joanne Gallivan,
M.S., R.D., Director, National Diabetes
Education Program, NIDDK, NIH,
Building 31, Room 9A06, 31 Center
Drive, Bethesda, MD 20892, call the
non-toll-free number 301–494–6110 or
VerDate Aug<31>2005
17:59 Sep 05, 2008
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e-mail your request, including your
address to: Joanne_Gallivan@nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Dated: June 9, 2008.
Elizabeth E. Greene,
Executive Officer, NIDDK, National Institutes
of Health.
Editorial Note: This document was
received in the Office of the Federal Register
on September 3, 2008.
[FR Doc. E8–20636 Filed 9–5–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; Simulations for Drug Related
Science Education
SUMMARY: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institute on Drug Abuse (NIDA), the
National Institutes of Health (NIH) has
submitted to the Office of Management
and Budget (OMB) a request for review
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Total hour
burden
and approval of the information
collection listed below. This proposed
information collection was previously
published in the Federal Register on
June 26, 2008, (Vol. 73 No. 124, page
36337) and allowed 60-days for public
comment. No public comments were
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 September 24,
2008, unless it displays a currently valid
OMB control number.
Proposed Collection: Title:
Simulations for Drug Related Science
Education. Type of Information
Collection Request: NEW. Need and Use
of Information Collection: This is a
request for a one-time clearance to
evaluate an interactive multimedia
module developed by ArchieMD. This
evaluation seeks to determine whether
the multimedia module Archie MD: The
Science of Drugs (1) Increases students’
knowledge in brain and heart biology
and the effects drugs have on the body
(2) Increases positive attitudes towards
science education for high school
students (3) Reinforce or instill negative
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[Federal Register Volume 73, Number 174 (Monday, September 8, 2008)]
[Notices]
[Pages 52052-52053]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-20636]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; the National Diabetes
Education Program Comprehensive Evaluation Plan
SUMMARY: 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 National Institute of
Diabetes and Digestive and Kidney Diseases (NIDDK), the National
Institutes of Health (NIH) will publish periodic summaries of proposed
projects to be submitted to the Office of Management and Budget (OMB)
for review and approval.
Proposed Collection: Title: The National Diabetes Education Program
Comprehensive Evaluation Plan. Type of Information Collection Request:
Extension of a currently approved collection (0925-0552). 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 goals of the
NDEP are to: Improve the treatment and health outcomes of people with
diabetes, promote early diagnosis, and, ultimately, prevent the onset
of diabetes. The NDEP objectives are: (1)
[[Page 52053]]
To increase awareness of the seriousness of diabetes, its risk factors,
and strategies for preventing diabetes and its complications among
people at risk for diabetes; (2) to improve understanding about
diabetes and its control and to promote better self-management
behaviors among people with diabetes; (3) to improve health care
providers' understanding of diabetes and its control and to promote an
integrated approach to care; (4) to promote health care policies that
improve the quality of and access to diabetes care.
Multiple strategies have been devised to address the NDEP
objectives. These have been described in the NDEP Strategic Plan and
include: (1) Creating partnerships with other organizations concerned
about diabetes; (2) developing and implementing awareness and education
activities with special emphasis on reaching the racial and ethnic
populations disproportionately affected by diabetes; (3) identifying,
developing, and disseminating educational tools and resources for the
program's diverse audiences; (4) promoting policies and activities to
improve the quality of and access to diabetes care.
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. 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 generic clearance request is for the
collection of additional primary data from NDEP target audiences on
some key process and impact measures that are necessary to effectively
evaluate the program. Approval is requested for a survey of audiences
targeted by the National Diabetes Education Program including people at
risk for diabetes, people with diabetes and their families and the
public.
Frequency of Response: On occasion. Affected Public: Individuals or
households. Type of Respondents: Adults. The annual reporting burden is
as follows: Estimated Number of Respondents: 3759, Estimated Number of
Responses per Respondent: 1; Average Burden Hours per Response: .153;
and Estimated Total Annual Burden Hours Requested: 575. There are no
Capital, Operating or Maintenance Costs to report.
Estimates of Hour Burden
----------------------------------------------------------------------------------------------------------------
Average
Type of respondents Number of Frequency time per Total hour
respondents of response response burden
----------------------------------------------------------------------------------------------------------------
Screening interview with ineligible persons................. 1659 1 .03 50
Eligible respondents........................................ 2100 1 .25 525
---------------------------------------------------
Totals.................................................. 3759 ........... ........... 575
----------------------------------------------------------------------------------------------------------------
Request for Comments: Written comments and/or suggestions from the
public and affected agencies are invited on one or more of the
following points: (1) Whether the proposed collection of information is
necessary for the proper performance of the function of the agency,
including whether the information will have practical utility; (2) The
accuracy of the agency'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 those who are to
respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact Joanne Gallivan, M.S., R.D., Director, National
Diabetes Education Program, NIDDK, NIH, Building 31, Room 9A06, 31
Center Drive, Bethesda, MD 20892, call the non-toll-free number 301-
494-6110 or e-mail your request, including your address to: Joanne_
Gallivan@nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.
Dated: June 9, 2008.
Elizabeth E. Greene,
Executive Officer, NIDDK, National Institutes of Health.
Editorial Note: This document was received in the Office of the
Federal Register on September 3, 2008.
[FR Doc. E8-20636 Filed 9-5-08; 8:45 am]
BILLING CODE 4140-01-P
