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 (33 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 firstname.lastname@example.org. 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.
Creation of State and Metropolitan Area-based Surveillance Projects for Amyotrophic Lateral Sclerosis (ALS)—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 diagnosed 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.
This project purposes to collect information-specific data related to ALS. The objective of this project is to develop state-based and metropolitan area-based surveillance projects for ALS. The primary goal of the state-based and metropolitan area-based surveillance project is to use these data to evaluate the completeness of the National ALS Registry. The secondary goal of the surveillance project is to obtain reliable and timely information on the incidence and prevalence of ALS and to better describe the demographic characteristics (e.g., age, race, sex, and geographic location) of those with ALS.
Neurologists or their staff will complete an ALS Case Reporting Form on each of their ALS patients. This will be transmitted to the state or metropolitan health department. The contract surveillance staff assigned to the state and metropolitan area health departments will train medical personnel how to complete the ALS Case Reporting Form (Attachment 3) and assist with abstracting records as requested. An ALS Medical Record Verification Form will be collected on a subset of cases reported. Each medical provider reporting source should keep a line listing of individuals diagnosed with or thought to have ALS along with information on whether or not the case was reported and if not, the reason. Surveillance items to be collected include information to make sure that there are no duplicates. There are no costs to the respondents other than their time. The estimated annualized burden hours are 703.
|Type of data collection instrument||Type of respondent||Number of respondents||Number of responses per respondent||Average burden per response (in hours)|
|ALS Case Reporting Form||Medical Personnel/Neurologist||2,250||1||5/60|
|ALS Medical Record Verification Form||Neurologist||450||1||20/60|
|Line Listing (record keeping)||Medical Personnel||243||1||1|
Dated: November 4, 2010.
Carol E. Walker,
Acting Reports Clearance Officer, Centers for Disease Control and Prevention/Agency for Toxic Substances and Disease Registry.
[FR Doc. 2010-28337 Filed 11-9-10; 8:45 am]
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