ALS Advocacy

ALS Advocacy
Lou Gehrig's Disease - Motor Neuron Disease - Amyotrophic Lateral Sclerosis
Thought it had been cured by now? Still no known cause. Still no cure. Still quickly fatal. Still outrageous.

Saturday, January 30, 2010

Following is Verbatim From The January 28, 2010, Federal Register


[Federal Register: January 28, 2010 (Volume 75, Number 18)]
[Notices]
[Page 4568-4569]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28ja10-66]

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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 omb@cdc.gov. 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
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Forms for ALS respondents Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------


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

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