[Federal Register Volume 78, Number 29 (Tuesday, February 12, 2013)]
[Notices]
[Pages 9922-9923]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-03193]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-13-0041]
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 404-639-7570 or
send comments to Kimberly S. Lane, 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 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
Registration of individuals with Amyotrophic Lateral Sclerosis
(ALS) in the National ALS Registry--Revision--(0923-0041, Expiration 7/
31/2013)--Agency for Toxic Substances and Disease Registry (ATSDR),
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.
After piloting methodology, on October 18, 2010, the Agency for
Toxic Substances and Disease Registry (ATSDR) launched the registration
component of the National ALS Registry www.cdc.gov/als.
The registration portion of the data collection is 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 are a
series of short surveys to collect information on such things as
military history, occupations, residential history, and family history
that would not likely be available from other sources.
[[Page 9923]]
This project proposes to continue collecting information on
individuals with ALS which can be combined with information obtained
from existing sources of information and add additional optional risk
factor surveys. 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 has been advertised by ATSDR and
advocacy groups such as the Amyotrophic Lateral Sclerosis Association
(ALSA) and the Muscular Dystrophy Association (MDA).
There are between 15,000 and 30,000 individuals living with ALS at
any given time. In addition, approximately 6,000 people are diagnosed
with ALS each year and we expect about one-quarter 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.
Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Type of respondent Form name respondents responses per response (in (in hours)
respondent hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Person with ALS................................ Validation questions (Screener) for 1670 1 2/60 56
suspected ALS cases.
Registration Form of ALS cases......... 1500 1 7/60 175
Cases of ALS completing 1-time surveys. 750 16 5/60 1000
Cases of ALS completing twice yearly 750 2.7 5/60 169
surveys*.
Total...................................... ....................................... .............. .............. .............. 1400
--------------------------------------------------------------------------------------------------------------------------------------------------------
* The disease progression survey is taken initial and then 3 times the first year (3, 6, 12 months after the initial survey). Because some people's
disease progresses more rapidly, clinicians recommended adding the survey at 3 months to make sure everyone had the opportunity to take the survey a
second time. In years 2 and 3, the survey would be taken at 6 and 12 months.
Kimberly S. Lane,
Deputy Director, Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the Director, Centers for
Disease Control and Prevention.
[FR Doc. 2013-03193 Filed 2-11-13; 8:45 am]
BILLING CODE P