[Federal Register Volume 74, Number 101 (Thursday, May 28, 2009)]
[Notices]
[Pages 25552-25553]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-12397]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-0923-09BR]


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 Maryam I. Daneshvar, CDC Acting Reports Clearance 
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail 
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--New--Agency for Toxic Substances 
and Disease Registry (ATSDR), Coordinating

[[Page 25553]]

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 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.
    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.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
     Data collection instruments/respondents         Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
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Validation questions (Screener) for suspected              6,000               1            2/60             200
 ALS cases......................................
Registration Form of ALS cases..................           4,667               1            7/60             544
Cases of ALS completing 1-time surveys..........           2,334               6            5/60            1167
Cases of ALS completing twice yearly surveys....           2,334               2            5/60             389
                                                 ---------------------------------------------------------------
Total...........................................  ..............  ..............  ..............            2300
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    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]
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