[Federal Register Volume 81, Number 127 (Friday, July 1, 2016)]
[Notices]
[Pages 43202-43203]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15645]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[30Day-16-0041]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Agency for Toxic Substances and Disease Registry (ATSDR) has 
submitted the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (a) 
Evaluate whether the proposed collection of information is necessary 
for the proper performance of the functions of the agency, including 
whether the information will have practical utility; (b) Evaluate the 
accuracy of the agencies estimate of the burden of the proposed 
collection of information, including the validity of the methodology 
and assumptions used; (c) Enhance the quality, utility, and clarity of 
the information to be collected; (d) Minimize the burden of the 
collection of information on those who are to respond, including 
through the use of appropriate automated, electronic, mechanical, or 
other technological collection techniques or other forms of information 
technology, e.g., permitting electronic submission of responses; and 
(e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570 or send an email to [email protected]. Direct written comments 
and/or suggestions regarding the items contained in this notice to the 
Attention: CDC 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

National Amyotrophic Lateral Sclerosis (ALS) Registry--Revision--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 ongoing effort to maintain the 
National ALS Registry.
    First approved in 2010 for self-registration, the primary goal of 
the surveillance system/registry remains to obtain reliable information 
on the incidence and prevalence of ALS and to better describe the 
demographic characteristics (age, race, sex, and geographic location) 
of persons with ALS (PALS). Those interested in participating in the 
National ALS Registry must answer a series of validation questions and 
if determined to be eligible they can register.
    The secondary goal of the surveillance system/registry is to 
collect additional information on potential risk factors for ALS, 
including, but not limited to, family history of ALS, smoking history, 
military service, residential history, life-time occupational exposure, 
home pesticide use, hobbies, hormonal and reproductive history (women 
only), caffeine use, trauma, health insurance, open-ended supplemental 
questions, and clinical signs and symptoms. After registration, 
participants complete as many as 16 voluntary survey modules, each 
taking five minutes (maximum 80 minutes). In addition, in Year 1, a 
disease progression survey for new registrants is completed at 0, 3, 
and 6 months. In Years 2 and 3, the disease progression survey is 
repeated at the yearly anniversary and at 6 months. For burden 
estimation, the number of disease progression survey responses per year 
has been rounded up to 3 times.
    A biorepository component is being added to increase the value of 
the National ALS Registry to researchers. As part of registration the 
participant can request additional information about the biorepository 
and provide additional contact information. A geographically 
representative sample will be selected to provide specimens. There are 
two types of specimen collections, in-home and postmortem. The in-home 
collection includes blood, urine, hair and nails. The postmortem 
collection includes the brain, spinal cord, cerebral spinal fluid 
(CSF), bone, muscle, and skin.
    In addition to fulfilling the two-part Congressional mandate, the 
Registry is designed to be a tool for ALS researchers. Now that the 
Registry has matured, ATSDR will make data and specimens available to 
researchers. They can request access to specimens, data, or both 
collected by the National ALS Registry for their research projects. 
ATSDR will review applications for scientific validity and human 
subjects protection and make data/specimens available to approved 
researchers.
    ATSDR is also collaborating with ALS service organizations to 
conduct outreach activities through their local chapters and districts 
as well as on a national level. They will provide ATSDR with 
information on their outreach efforts in support of the Registry on a 
monthly basis.
    There are no costs to the respondents other than their time. The 
total number

[[Page 43203]]

of burden hours requested is 1,824 hours.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
        Type of respondents                   Form name             respondents    responses per   response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Person with ALS....................  ALS Case Validation                   1,670               1            2/60
                                      Questions.
                                     ALS Case Registration Form.           1,500               1           10/60
                                     Voluntary Survey Modules...             750               1           80/60
                                     Disease Progression Survey.             750               3            5/60
                                     ALS Biorepository Specimen              325               1           30/60
                                      Processing Form.
Researchers........................  ALS Registry Research                    36               1           30/60
                                      Application Form.
                                     Annual Update..............              24               1           15/60
ALS Service Organization...........  Chapter/District Outreach               135              12            5/60
                                      Reporting Form.
                                     National Office Outreach                  2              12           20/60
                                      Reporting Form.
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Jeffrey M. Zirger,
Health Scientist, Acting Chief, Information Collection Review Office, 
Office of Scientific Integrity, Office of the Associate Director for 
Science, Office of the Director, Centers for Disease Control and 
Prevention.
[FR Doc. 2016-15645 Filed 6-30-16; 8:45 am]
 BILLING CODE 4163-18-P