[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]


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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
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                                                                                                                              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
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* 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]
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