Proposed Data Collections Submitted for Public Comment and Recommendations, 25553-25554 [E9-12393]
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Federal Register / Vol. 74, No. 101 / Thursday, May 28, 2009 / Notices
Center for Environmental Health and
Injury Prevention (CCEHIP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
On October 10, 2008, President Bush
signed S. 1382: ALS Registry Act which
amended the Public Health Service Act
to provide for the establishment of an
Amyotrophic Lateral Sclerosis (ALS)
Registry. The activities described are
part of the effort to create the National
ALS Registry. The purpose of the
registry is to: (1) Better describe the
incidence and prevalence of ALS in the
United States; (2) examine appropriate
factors, such as environmental and
occupational, that might be associated
with the disease; (3) better outline key
demographic factors (such as age, race
or ethnicity, gender, and family history)
associated with the disease; and (4)
better examine the connection between
ALS and other motor neuron disorders
that can be confused with ALS,
misdiagnosed as ALS, and in some cases
progress to ALS. The registry will
collect personal health information that
may provide a basis for further scientific
studies of potential risks for developing
ALS.
During a workshop held by The
Agency for Toxic Substances and
Disease Registry (ATSDR) in March
2006 to discuss surveillance of selected
autoimmune and neurological diseases,
it was decided to develop a proposal to
build on work that had already been
done and coordinate existing datasets to
This project proposes to collect
information on individuals with ALS
which can be combined with
information obtained from existing
sources of information. This combined
data will become the National ALS
Registry and will be used to provide
more accurate estimates of the incidence
and prevalence of disease as well as the
demographic characteristics of the
cases. Information obtained from the
surveys will be used to better
characterize potential risk factors for
ALS which will lead to further in-depth
studies.
The existence of the Web site will be
advertised by ATSDR and advocacy
groups such as the Amyotrophic Lateral
Sclerosis Association (ALSA) and the
Muscular Dystrophy Association
(MDA).
There will be approximately 30,000
individuals living with ALS when the
National ALS Registry is initiated, and
it is estimated that approximately 25%
of those individuals will also
participate. In addition, approximately
6,000 people are diagnosed with ALS
each year and we expect about one-third
of them will participate in the registry.
Because an advantage to registration is
participating in the surveys, we expect
the one time surveys, and the twice
yearly survey participation rate will be
50%.
There are no costs to the respondents
other than their time.
create a larger database, rather than to
start from scratch with medical records
review and physician reporting. Four
pilot projects were funded to evaluate
the accuracy and reliability of existing
data from the Center for Medicare and
Medicaid Services (CMS) and various
datasets from the Veterans
Administration. Preliminary results
indicate that additional ways to identify
cases of ALS will be necessary to
increase completeness of the registry.
Therefore, ATSDR developed a Web site
where individuals will register and will
also have the opportunity to provide
additional information on such things as
occupation, military service, and family
history of ALS, which is not available in
existing records.
The registration portion of the data
collection will be limited to information
that can be used to identify an
individual to assure that there are not
duplicate records for an individual.
Avoiding duplication of registrants due
to obtaining records from multiple
sources is imperative to get accurate
estimates of incidence and prevalence,
as well as accurate information on
demographic characteristics of the cases
of ALS.
In addition to questions required for
registration, there will be a series of
short surveys to collect information on
such things as military history,
occupations, and family history that
would not likely be available from other
sources.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Data collection instruments/respondents
Average
burden per
response
(in hours)
Number of
responses per
respondent
Total burden
(in hours)
Validation questions (Screener) for suspected ALS cases .............................
Registration Form of ALS cases ......................................................................
Cases of ALS completing 1-time surveys .......................................................
Cases of ALS completing twice yearly surveys ..............................................
6,000
4,667
2,334
2,334
1
1
6
2
2/60
7/60
5/60
5/60
200
544
1167
389
Total .................................................................................................................
........................
........................
........................
2300
Dated: May 20, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E9–12397 Filed 5–27–09; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE P
[60Day–09–0214]
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
VerDate Nov<24>2008
17:11 May 27, 2009
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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 project or to obtain a copy of
data collection plans and instruments,
call the CDC Reports Clearance Officer
on 404–639–5960 or send comments to
CDC Assistant Reports Clearance
Officer, 1600 Clifton Road, MS D–74,
Atlanta, GA 30333 or send an e-mail to
omb@cdc.gov.
Comments are invited on: (a) Whether
the proposed collection of information
E:\FR\FM\28MYN1.SGM
28MYN1
25554
Federal Register / Vol. 74, No. 101 / Thursday, May 28, 2009 / Notices
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 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
National Health Interview Survey
(NHIS), (OMB No. 0920–0214)—
Revision—National Center for Health
Statistics (NCHS), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
Section 306 of the Public Health
Service (PHS) Act (42 U.S.C. 242k), as
amended, authorizes that the Secretary
of Health and Human Services (DHHS),
acting through NCHS, shall collect
statistics on the extent and nature of
illness and disability of the population
of the United States.
The annual National Health Interview
Survey is a major source of general
statistics on the health of the U.S.
population and has been in the field
continuously since 1957. Clearance is
sought for three years, to collect data for
2010, 2011, and 2012. This voluntary
household-based survey collects
demographic and health-related
information on a nationally
representative sample of persons and
households throughout the country.
Information is collected using computer
assisted personal interviews (CAPI). A
core set of data is collected each year
while sponsored supplements vary from
year to year. For 2010, supplement
information will be collected on cancer,
occupational injury, epilepsy, and child
mental health. The child mental health
component includes a follow-up study
to assess the validity of a short series of
questions for measuring mental distress
in children.
In accordance with the 1995 initiative
to increase the integration of surveys
within the Department of Health and
Human Services, respondents to the
NHIS serve as the sampling frame for
the Medical Expenditure Panel Survey
conducted by the Agency for Healthcare
Research and Quality. The NHIS has
long been used by government,
university, and private researchers to
evaluate both general health and
specific issues, such as cancer, diabetes,
and access to health care. It is a leading
source of data for the Congressionallymandated ‘‘Health US’’ and related
publications, as well as the single most
important source of statistics to track
progress toward the National Health
Promotion and Disease Prevention
Objectives, ‘‘Healthy People 2010.’’
There is no cost to the respondents
other than their time.
ANNUALIZED BURDEN TABLE
Average
burden per
response
in hours
Number of
responses per
respondent
Questionnaire
(respondent)
Number of
respondents
Screener Questionnaire (adult family member) ...............................................
Family Core (adult family member) .................................................................
Adult Core (sample adult) ................................................................................
Child Core (adult family member) ....................................................................
Adult Cancer (sample adult) ............................................................................
Child Cancer (adult family member) ................................................................
Adult Occupational Injury (sample adult) .........................................................
Adult Epilepsy (sample adult) ..........................................................................
Child Mental Health (adult family member) .....................................................
Child Mental Health Follow-Up (parent) ..........................................................
Child Mental Health Follow-Up (child) .............................................................
Re-interview Survey) .......................................................................................
10,000
33,000
25,000
10,000
25,000
10,000
25,000
25,000
10,000
430
319
........................
1
1
1
1
1
1
1
1
1
1
1
1
5/60
23/60
17/60
9/60
19/60
1/60
2/60
1/60
2/60
40/60
28/60
5/60
833
12,650
7,083
1,500
7,917
167
833
417
333
287
149
250
Total Burden Hours ..................................................................................
........................
........................
........................
32,419
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Office of
the Chief Science Officer, Centers for Disease
Control and Prevention.
[FR Doc. E9–12393 Filed 5–27–09; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
Food and Drug Administration
DATES: Fax written comments on the
collection of information by June 29,
2009.
[Docket No. FDA–2009–N–0050]
BILLING CODE 4163–18–P
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Importer’s Entry
Notice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
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17:11 May 27, 2009
Jkt 217001
Total burden
in hours
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0046. Also
include the FDA docket number found
in brackets in the heading of this
document.
E:\FR\FM\28MYN1.SGM
28MYN1
Agencies
[Federal Register Volume 74, Number 101 (Thursday, May 28, 2009)]
[Notices]
[Pages 25553-25554]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-12393]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-09-0214]
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 project or to obtain a copy
of data collection plans and instruments, call the CDC Reports
Clearance Officer on 404-639-5960 or send comments to CDC Assistant
Reports Clearance Officer, 1600 Clifton Road, MS D-74, Atlanta, GA
30333 or send an e-mail to omb@cdc.gov.
Comments are invited on: (a) Whether the proposed collection of
information
[[Page 25554]]
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 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
National Health Interview Survey (NHIS), (OMB No. 0920-0214)--
Revision--National Center for Health Statistics (NCHS), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Section 306 of the Public Health Service (PHS) Act (42 U.S.C.
242k), as amended, authorizes that the Secretary of Health and Human
Services (DHHS), acting through NCHS, shall collect statistics on the
extent and nature of illness and disability of the population of the
United States.
The annual National Health Interview Survey is a major source of
general statistics on the health of the U.S. population and has been in
the field continuously since 1957. Clearance is sought for three years,
to collect data for 2010, 2011, and 2012. This voluntary household-
based survey collects demographic and health-related information on a
nationally representative sample of persons and households throughout
the country. Information is collected using computer assisted personal
interviews (CAPI). A core set of data is collected each year while
sponsored supplements vary from year to year. For 2010, supplement
information will be collected on cancer, occupational injury, epilepsy,
and child mental health. The child mental health component includes a
follow-up study to assess the validity of a short series of questions
for measuring mental distress in children.
In accordance with the 1995 initiative to increase the integration
of surveys within the Department of Health and Human Services,
respondents to the NHIS serve as the sampling frame for the Medical
Expenditure Panel Survey conducted by the Agency for Healthcare
Research and Quality. The NHIS has long been used by government,
university, and private researchers to evaluate both general health and
specific issues, such as cancer, diabetes, and access to health care.
It is a leading source of data for the Congressionally-mandated
``Health US'' and related publications, as well as the single most
important source of statistics to track progress toward the National
Health Promotion and Disease Prevention Objectives, ``Healthy People
2010.''
There is no cost to the respondents other than their time.
Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Questionnaire (respondent) Number of responses per per response Total burden
respondents respondent in hours in hours
----------------------------------------------------------------------------------------------------------------
Screener Questionnaire (adult family member).... 10,000 1 5/60 833
Family Core (adult family member)............... 33,000 1 23/60 12,650
Adult Core (sample adult)....................... 25,000 1 17/60 7,083
Child Core (adult family member)................ 10,000 1 9/60 1,500
Adult Cancer (sample adult)..................... 25,000 1 19/60 7,917
Child Cancer (adult family member).............. 10,000 1 1/60 167
Adult Occupational Injury (sample adult)........ 25,000 1 2/60 833
Adult Epilepsy (sample adult)................... 25,000 1 1/60 417
Child Mental Health (adult family member)....... 10,000 1 2/60 333
Child Mental Health Follow-Up (parent).......... 430 1 40/60 287
Child Mental Health Follow-Up (child)........... 319 1 28/60 149
Re-interview Survey)............................ .............. 1 5/60 250
---------------------------------------------------------------
Total Burden Hours.......................... .............. .............. .............. 32,419
----------------------------------------------------------------------------------------------------------------
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Office of the Chief Science Officer,
Centers for Disease Control and Prevention.
[FR Doc. E9-12393 Filed 5-27-09; 8:45 am]
BILLING CODE 4163-18-P