Proposed Data Collections Submitted for Public Comment and Recommendations, 7860-7862 [2011-3080]
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7860
Federal Register / Vol. 76, No. 29 / Friday, February 11, 2011 / Notices
Information will be collected for three
years through a data collection
contractor, which will serve as the
SEARCH study Coordinating Center.
Data will be transmitted electronically
to the Coordinating Center through a
secure, dedicated Web site. Information
can be entered and transmitted at any
time. The information collection has
three components:
The Registry Study will collect
information on newly diagnosed
incident diabetes cases in youth age
< 20 years. CDC estimates that each
clinical site will identify and register an
average of 255 cases per year. The items
collected for each case include an
Extended Core, Medication Inventory,
Inpatient Survey, Specimen Collection
(Registry version), and Physical Exam
(Registry version). The total estimated
Information will also be collected for
the purpose of monitoring unanticipated
occurrences and conditions. CDC
estimates that each site will report an
average of 13 unanticipated occurrences
per year.
Respondents will be the five study
sites funded for SEARCH Phase 3.
Participation in the data collection is
required for the study sites, but
participation in the SEARCH study is
voluntary for individuals who are
followed at those sites. The estimated
annualized burden per study site is
426.4 hours. The total estimated
annualized burden for all sites is 2,132
hours.
There are no costs to respondents
other than their time.
annualized burden for this information
collection is 744 hours.
The Cohort Study is a longitudinal
research study about SEARCH cases
whose diabetes was incident in 2002 or
later. CDC estimates that each clinical
site will conduct follow-up on an
average of 142 cases per year. The items
collected for each case include a Health
Questionnaire (Youth version), an
additional Health Questionnaire (Parent
version), CES—Depression, Medical
Record Validation, Quality of Care, Peds
QL, SEARCH MNSI Neuropathy,
Diabetes Eating Survey, Low Blood
Sugar Survey, Supplemental Survey,
Tanner Stage, Retinal Photo, Family
Conflict Survey, Pediatric Quality of
Life Scale, Physical Exam, and
Specimen Collection.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents
SEARCH
Study).
SEARCH
Study).
Clinical
Sites
Clinical
Sites
Total burden
(in hours)
Extended Core .................................
5
255
10/60
213
(Cohort
Medication Inventory ........................
Inpatient Survey ...............................
Specimen Collection (Registry) ........
Physical Exam (Registry) .................
Health Questionnaire—Youth ..........
........................
........................
........................
........................
5
........................
........................
........................
........................
142
5/60
10/60
5/60
5/60
15/60
106
213
106
106
178
Health Questionnaire—Parent .........
CES–Depression ..............................
Medical Record Validation ...............
Quality of Care .................................
Peds QL ...........................................
SEARCH MNSI Neuropathy ............
Diabetes Eating Survey ...................
Low Blood Sugar Survey .................
Supplemental ...................................
Tanner Stage ...................................
Retinal Photo ....................................
Family Conflict ..................................
Pediatric Diabetes QOL Scale .........
Physical Exam ..................................
Specimen Collection ........................
Unanticipated Occurrence/Condition
Reporting Form.
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
5
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
13
15/60
4/60
10/60
13/60
5/60
5/60
5/60
5/60
10/60
5/60
5/60
5/60
5/60
5/60
5/60
5/60
178
47
118
154
59
59
59
59
118
59
59
59
59
59
59
5
...........................................................
........................
........................
........................
2,132
Total ...........................................
Dated: February 7, 2011.
Carol E. Walker,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2011–3081 Filed 2–10–11; 8:45 am]
Centers for Disease Control and
Prevention
BILLING CODE 4163–18–P
[60Day–11–11CD]
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
VerDate Mar<15>2010
Average
burden per
response
(Registry
SEARCH Clinical Sites (Monitoring)
jlentini on DSKJ8SOYB1PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
Form name
18:55 Feb 10, 2011
Jkt 223001
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
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 404–639–5960 and
send comments to Carol E. Walker, CDC
Acting Reports Clearance Officer, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an e-mail to
omb@cdc.gov.
E:\FR\FM\11FEN1.SGM
11FEN1
7861
Federal Register / Vol. 76, No. 29 / Friday, February 11, 2011 / Notices
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
Tourette Syndrome National
Education and Outreach Program—
New—National Center on Birth Defects
and Developmental Disabilities
(NCBDDD), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
This program will collect program
evaluation data from participants of
educational workshops and recipients of
educational resources on Tourette
Syndrome (TS) conducted by the
Tourette Syndrome Association in a
cooperative agreement with the CDC.
TS is an inherited, neurobiological
movement disorder characterized by
involuntary motor and vocal tics that
educational settings, limiting their
educational and social success.
To address these issues, the Tourette
Syndrome Association has developed
educational workshops and materials to
improve the recognition and awareness
of TS diagnosis, treatment, co-occurring
conditions, and quality of life for those
impacted by TS. Health education
programs have been developed for 3
groups of audiences: Health
professionals, education professionals,
and people with TS and their families.
The format includes general education
programs for the 3 groups, as well as
two more in-depth medical training
programs for physicians on TS and on
the Comprehensive Behavioral
Intervention for Tics (CBIT) treatment.
In addition, a range of professional
health education materials in various
formats have been developed as
educational resources and will be
disseminated.
CDC requests OMB approval to collect
program evaluation information from
workshop participants and recipients of
educational materials over a three-year
period. Participants of the workshops
and recipients of educational resources
will be completing program evaluation
forms to provide information on
whether the workshop or resource met
the educational goals. The information
will be used to improve future
workshops.
There are no costs to respondents
other than their time.
typically manifest during childhood.
The exact number of people with TS is
unknown. Data from the National
Survey of Children’s Health 2007
resulted in an estimate that 3 out of
every 1,000 U.S. children (about
148,000) 6 through 17 years of age had
been diagnosed with TS. Higher
prevalence estimates obtained from
community studies likely mean that
there are a significant number of
individuals who have TS, but who have
not been diagnosed. TS is three to four
times more common among males than
females.
It is estimated that tens of thousands
or Americans with TS either go
undiagnosed or the clinical care they do
receive is inadequate. There is no
known cure. The disorder may express
itself with mild symptoms for some, and
severe symptoms for others. Depending
on the severity and duration, tic
symptoms may also be diagnosed as
chronic motor or vocal tic disorder,
transient tic disorder, and tic disorder
not otherwise specified. TS is associated
with a high rate of co-morbid
conditions.
There is a lack of accurate treatment
information among the medical
community as well as the general
public, and a limited number of expert
physicians—all resulting in significant
under-diagnosis, misdiagnosis, and
inadequate treatment with scant followup care. Children also meet with stigma
and inadequate responses in
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hrs)
Total burden
hours
Type of respondents
Form name
Health professionals .................
Teachers/Educators .................
Public ........................................
1,000
1,000
200
1
1
1
2/60
2/60
2/60
33
33
7
200
1
2/60
7
Health professionals .................
Health professionals .................
Health professionals .................
Health professionals .................
Health professionals .................
Health professionals .................
Teachers/Educators .................
Public ........................................
Health professionals .................
Medical Education Program Evaluation ....
Education Program Evaluation .................
Family/Public Education Program Evaluation.
Family/Public Medical Program Evaluation.
CBIT Education Program Evaluation ........
CBIT pre-post test .....................................
Physician Retreat pre-post test ................
Physician Training Retreat follow up ........
CBIT Program 3 month follow-up .............
CBIT Online Evaluation ............................
Education Resource Dissemination ..........
Family Resource Dissemination ...............
Medical Resource Dissemination .............
500
500
50
30
300
50
210
200
210
1
2
2
1
1
1
1
1
1
2/60
3/60
3/60
2/60
1/60
1/60
2/60
2/60
2/60
17
50
5
1
5
1
7
7
7
Total ..................................
...................................................................
........................
........................
........................
180
jlentini on DSKJ8SOYB1PROD with NOTICES
Public ........................................
VerDate Mar<15>2010
18:55 Feb 10, 2011
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E:\FR\FM\11FEN1.SGM
11FEN1
7862
Federal Register / Vol. 76, No. 29 / Friday, February 11, 2011 / Notices
Dated: February 7, 2011.
Carol E. Walker,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2011–3080 Filed 2–10–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Implementation of the James Zadroga
9/11 Health and Compensation Act of
2010 (Pub. L. 111–347)
The National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC),
Department of Health and Human
Services (HHS) announces a public
meeting for receiving comments from
the public on implementing the
provisions of the James Zadroga 9/11
Health and Compensation Act of 2010
(Pub. L. 111–347). The Federal
government is developing an
implementation plan, and comments
from the public will assist in this
process by gaining perspectives from
interested parties on ways to meet the
Act’s requirements.
SUMMARY:
Table of Contents
jlentini on DSKJ8SOYB1PROD with NOTICES
Date and Time
Address
Status
Security Considerations
Speaker Registration
Agenda
Contact Person for More Information
Supplementary Information
I. Background
II. Matters To Be Discussed
III. Transcripts
Date and Time: March 3, 2011,
9 a.m.–4:45 p.m., Eastern Time. Please
note that public comments may end
before the time indicated, following the
last call for comments. Members of the
public who wish to provide public
comments should plan to attend the
meeting at the start time listed.
Addresses: Jacob K. Javits Federal
Building, 26 Federal Plaza, Broadway
entrance, 6th Floor, Conference Room
A/B, New York, New York 10278.
Status: The meeting is open to the
public, limited only by the space
available. The meeting space
accommodates approximately 300
people. In addition, there will be an
audio conference setup for those who
cannot attend in person. The conference
line will accommodate up to 300 callers.
The USA toll-free dial-in number is
800–619–8873; pass code 8693287.
VerDate Mar<15>2010
18:55 Feb 10, 2011
Jkt 223001
Additionally, there is no registration fee
to attend this public meeting.
Security Considerations: Due to
mandatory security clearance
procedures at the Jacob K. Javits Federal
Building, in-person attendees must
present valid government-issued picture
identification to security personnel
upon entering the building and go
through an airport-type security check.
Non-U.S. citizens are encouraged to
participate in the audio conferencing
due to the extra clearance involved with
in-person attendance. To attend inperson, a non-U.S. citizen will have to
call or send an e-mail before February
16, 2011, to the contact person in this
Notice, and provide passport
information. If clearance is received,
you will be notified; otherwise, you will
not be able to attend the meeting inperson.
Speaker Registration: Individuals
wishing to speak during the meeting
may sign up on the speaker registration
list which will be available at the
meeting site beginning at 8:30 a.m., and
during the meeting.
Agenda: The meeting will begin with
a brief introduction by Federal officials,
followed by presentations from
attendees who register to speak. Each
speaker will be limited to five minutes
in order to maximize the number of
presentations during the meeting. If all
registered presentations are made before
the end time, there will be an open
session to receive comments from
anyone who has not signed up on the
speaker registration list who may wish
to speak. Open session comments will
also be limited to five minutes per
person. After the last speaker or at 4:45
p.m., whichever occurs first, the
meeting will be adjourned.
Contact Person for More Information:
Roy Fleming, Sc.D., NIOSH, CDC, 1600
Clifton Road, NE., Mailstop E–20,
Atlanta, Georgia 30333, Toll free:
1–866–426–3673, e-mail:
nioshdocket@cdc.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The James Zadroga 9/11 Health and
Compensation Act of 2010 established a
program known as the World Trade
Center (WTC) Health Program within
HHS. The program shall be
administered by the WTC Program
Administrator; the Act includes:
(1) Medical Monitoring for
Responders—Medical monitoring,
including clinical examinations and
long-term health monitoring and
analysis for enrolled WTC responders
who were likely to have been exposed
to airborne toxins that were released, or
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
to other hazards, as a result of the
September 11, 2001, terrorist attacks.
(2) Initial Health Evaluation for
Survivors—An initial health evaluation,
including an evaluation to determine
eligibility for follow-up monitoring and
treatment.
(3) Follow-up Monitoring and
Treatment for WTC–Related Health
Conditions for Responders and
Survivors—Provision of follow-up
monitoring and treatment and payment
for all medically necessary health and
mental health care expenses of an
individual with respect to a WTCrelated health condition (including
necessary prescription drugs).
(4) Outreach—Establishment of an
education and outreach program to
potentially eligible individuals
concerning the benefits under this title.
(5) Clinical Data Collection and
Analysis—Collection and analysis of
health and mental health data relating to
individuals receiving monitoring or
treatment benefits in a uniform manner
in collaboration with the collection of
epidemiological data.
(6) Research on Health Conditions—
Establishment of a research program on
health conditions resulting from the
September 11, 2001, terrorist attacks.
A full copy of the James Zadroga
9/11 Health and Compensation Act of
2010 (Pub. L. 111–347) is available in
NIOSH Docket #226, at: https://
www.cdc.gov/niosh/docket/.
II. Matters To Be Discussed
Input from the public is sought on any
of the provisions of the James Zadroga
9/11 Health and Compensation Act of
2010. The Federal government is
developing an implementation plan,
and comments from the public will
assist in this process by gaining
perspectives from interested parties on
ways to meet the Act’s requirements.
III. Transcripts
Transcripts will be prepared and
posted to NIOSH Docket #226 within 30
days after the meeting. If a person
making a comment gives his or her
name, no attempt will be made to redact
that name. NIOSH will take reasonable
steps to ensure that individuals making
public comments are aware of the fact
that their comments (including their
name, if provided) will appear in a
transcript of the meeting posted on a
public Web site. Such reasonable steps
include: (a) A statement read at the start
of the meeting stating that transcripts
will be posted and names of speakers
will not be redacted; and (b) A printed
copy of the statement mentioned in (a)
above will be displayed on the table
where individuals sign up to make
E:\FR\FM\11FEN1.SGM
11FEN1
]]>Agencies
[Federal Register Volume 76, Number 29 (Friday, February 11, 2011)]
[Notices]
[Pages 7860-7862]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-3080]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-11-11CD]
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 404-639-5960
and send comments to Carol E. Walker, CDC Acting Reports Clearance
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail
to omb@cdc.gov.
[[Page 7861]]
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
Tourette Syndrome National Education and Outreach Program--New--
National Center on Birth Defects and Developmental Disabilities
(NCBDDD), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
This program will collect program evaluation data from participants
of educational workshops and recipients of educational resources on
Tourette Syndrome (TS) conducted by the Tourette Syndrome Association
in a cooperative agreement with the CDC.
TS is an inherited, neurobiological movement disorder characterized
by involuntary motor and vocal tics that typically manifest during
childhood. The exact number of people with TS is unknown. Data from the
National Survey of Children's Health 2007 resulted in an estimate that
3 out of every 1,000 U.S. children (about 148,000) 6 through 17 years
of age had been diagnosed with TS. Higher prevalence estimates obtained
from community studies likely mean that there are a significant number
of individuals who have TS, but who have not been diagnosed. TS is
three to four times more common among males than females.
It is estimated that tens of thousands or Americans with TS either
go undiagnosed or the clinical care they do receive is inadequate.
There is no known cure. The disorder may express itself with mild
symptoms for some, and severe symptoms for others. Depending on the
severity and duration, tic symptoms may also be diagnosed as chronic
motor or vocal tic disorder, transient tic disorder, and tic disorder
not otherwise specified. TS is associated with a high rate of co-morbid
conditions.
There is a lack of accurate treatment information among the medical
community as well as the general public, and a limited number of expert
physicians--all resulting in significant under-diagnosis, misdiagnosis,
and inadequate treatment with scant follow-up care. Children also meet
with stigma and inadequate responses in educational settings, limiting
their educational and social success.
To address these issues, the Tourette Syndrome Association has
developed educational workshops and materials to improve the
recognition and awareness of TS diagnosis, treatment, co-occurring
conditions, and quality of life for those impacted by TS. Health
education programs have been developed for 3 groups of audiences:
Health professionals, education professionals, and people with TS and
their families. The format includes general education programs for the
3 groups, as well as two more in-depth medical training programs for
physicians on TS and on the Comprehensive Behavioral Intervention for
Tics (CBIT) treatment. In addition, a range of professional health
education materials in various formats have been developed as
educational resources and will be disseminated.
CDC requests OMB approval to collect program evaluation information
from workshop participants and recipients of educational materials over
a three-year period. Participants of the workshops and recipients of
educational resources will be completing program evaluation forms to
provide information on whether the workshop or resource met the
educational goals. The information will be used to improve future
workshops.
There are no costs to respondents other than their time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Type of respondents Form name respondents responses per response (in hours
respondent hrs)
----------------------------------------------------------------------------------------------------------------
Health professionals......... Medical Education 1,000 1 2/60 33
Program
Evaluation.
Teachers/Educators........... Education Program 1,000 1 2/60 33
Evaluation.
Public....................... Family/Public 200 1 2/60 7
Education
Program
Evaluation.
Public....................... Family/Public 200 1 2/60 7
Medical Program
Evaluation.
Health professionals......... CBIT Education 500 1 2/60 17
Program
Evaluation.
Health professionals......... CBIT pre-post 500 2 3/60 50
test.
Health professionals......... Physician Retreat 50 2 3/60 5
pre-post test.
Health professionals......... Physician 30 1 2/60 1
Training Retreat
follow up.
Health professionals......... CBIT Program 3 300 1 1/60 5
month follow-up.
Health professionals......... CBIT Online 50 1 1/60 1
Evaluation.
Teachers/Educators........... Education 210 1 2/60 7
Resource
Dissemination.
Public....................... Family Resource 200 1 2/60 7
Dissemination.
Health professionals......... Medical Resource 210 1 2/60 7
Dissemination.
----------------------------------------------------------------------------------
Total.................... ................. .............. .............. .............. 180
----------------------------------------------------------------------------------------------------------------
[[Page 7862]]
Dated: February 7, 2011.
Carol E. Walker,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. 2011-3080 Filed 2-10-11; 8:45 am]
BILLING CODE 4163-18-P
