[Federal Register Volume 75, Number 18 (Thursday, January 28, 2010)]
[Notices]
[Pages 4568-4569]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-1718]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-10-09BR]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC), Agency for 
Toxic Substances and Disease Registry (ATSDR) publishes a list of 
information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call 
the CDC Reports Clearance Officer at (404) 639-5960 or send an e-mail 
to [email protected]. Send written comments to ATSDR Desk Officer, Office of 
Management and Budget, Washington, DC 20503 or by fax to (202) 395-
5806. Written comments should be received within 30 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).

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 of 
individuals who are diagnosed with the disease) 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 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.

[[Page 4569]]

    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 are no costs 
to the respondents other than their time. The estimated annualized 
burden hours are 2300.

                                        Estimated Annualized Burden Hours
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                                                                                  Number of      Average burden
                Forms for ALS  respondents                      Number of       responses per     per response
                                                               respondents       respondent        (in hours)
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Validation questions......................................             6,000                 1              2/60
Registration of ALS cases.................................             4,667                 1              7/60
Cases of ALS completing 1-time surveys....................             2,334                 6              5/60
Cases of ALS completing twice yearly surveys..............             2,334                 2              5/60
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    Dated: January 22, 2010.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention, Agency for Toxic Substances and Disease Registry.
[FR Doc. 2010-1718 Filed 1-27-10; 8:45 am]
BILLING CODE 4163-18-P