[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
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Average
Number of Number of burden per
Type of respondents Form name respondents responses per response (in
respondent hours)
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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