[Federal Register Volume 84, Number 101 (Friday, May 24, 2019)]
[Notices]
[Pages 24143-24144]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10836]
[[Page 24143]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substance and Disease Registry
[60Day-19-0041; Docket No. ATSDR-2019-0007]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Agency for Toxic Substances and Disease Registry (ATSDR),
Department of Health and Human Services (HHS).
ACTION: Notice with comment period.
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SUMMARY: The Agency for Toxic Substances and Disease Registry (ATSDR),
as part of its continuing effort to reduce public burden and maximize
the utility of government information, invites the general public and
other Federal agencies the opportunity to comment on a proposed and/or
continuing information collection, as required by the Paperwork
Reduction Act of 1995. This notice invites comment on a proposed
information collection project titled ``National Amyotrophic Lateral
Sclerosis (ALS) Registry.'' The National ALS Registry collects
information from persons with ALS to better describe the prevalence and
potential risk factors for ALS.
DATES: ATSDR must receive written comments on or before July 23, 2019.
ADDRESSES: You may submit comments, identified by Docket No. ATSDR-
2019-0007 by any of the following methods:
Federal eRulemaking Portal: Regulations.gov. Follow the
instructions for submitting comments.
Mail: Jeffrey M. Zirger, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE, MS-D74, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. ATSDR will post, without change, all relevant
comments to Regulations.gov.
Please note: Submit all comments through the Federal eRulemaking
portal (regulations.gov) or by U.S. mail to the address listed above.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the information collection plan
and instruments, contact Jeffrey M. Zirger, Information Collection
Review Office, Centers for Disease Control and Prevention, 1600 Clifton
Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
[email protected].
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. In addition, the PRA also requires
Federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each new
proposed collection, each proposed extension of existing collection of
information, and each reinstatement of previously approved information
collection before submitting the collection to the OMB for approval. To
comply with this requirement, we are publishing this notice of a
proposed data collection as described below.
The OMB is particularly interested in comments that will help:
1. 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;
2. Evaluate the accuracy of the agency's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to
be collected; and
4. 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
submissions of responses.
5. Assess information collection costs.
Proposed Project
The National Amyotrophic Lateral Sclerosis (ALS) Registry (OMB
Control No. 0923-0041, Expiration Date 11/30/2019)--Revision--Agency
for Toxic Substances and Disease Registry (ATSDR).
Background and Brief Description
The Agency for Toxic Substances and Disease Registry (ATSDR) is
requesting a three-year Paperwork Reduction Act (PRA) clearance for the
National Amyotrophic Lateral Sclerosis (ALS) Registry (0923-0041,
Expiration Date 11/30/2019). The current request is a revision designed
to strengthen the usefulness of the National ALS Registry for
researchers. The changes to the ICR include:
(1) Addition of an organized sports participation survey to capture
history and current participation in physical activities. This
additional survey will take approximately 5 minutes to complete and
will add an additional 63 total burden hours for respondents;
(2) Two additional questions to capture race and ethnicity upon
registration with other basic demographic information will be added to
ALS Case Registration Form prior to Persons with ALS (PALS) completing
more detailed surveys.
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. 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, lifetime occupational exposure,
home pesticide use, hobbies, participation in sports, 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 17
voluntary survey modules, each taking up to five minutes. In addition,
in Year 1, a disease progression survey for new registrants is
completed at zero, three, and six months. In Year 2 and Year 3, the
disease progression survey is repeated at the yearly anniversary and at
six months. For burden estimation, the number of disease progression
survey responses per year has been rounded up to three times.
A biorepository component was added in 2016 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 is selected to provide specimens.
There are two types of specimen collections, in-home and postmortem.
The in-home
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collection includes blood, urine, and saliva. 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 has made data and specimens available to
approved researchers and has added a respondent type. Researchers 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
collaborating with ALS service organizations to conduct outreach
activities through their local chapters and districts as well as on a
national level. They 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.
Participation in this proposed information collection is completely
voluntary. The total number of burden hours requested is 1,946 hours.
Estimated Annualized Burden Hours
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No. of Average burden
Type of respondents Form name No. of responses per per response Total burden
respondents respondent (in hours) (in hours)
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Person with ALS................................ ALS Case Validation Questions.......... 1,670 1 2/60 56
ALS Case Registration Form............. 1,500 1 10/60 250
Voluntary Survey Modules............... 750 1 85/60 1,063
Disease Progression Survey*............ 750 3 5/60 188
ALS Biorepository Specimen Processing 325 1 30/60 163
Form and In-Home Collection.
ALS Biorepository Saliva Collection.... 350 1 10/60 59
Researchers.................................... ALS Registry Research Application Form. 36 1 30/60 18
Annual Update.......................... 24 1 15/60 6
ALS Service Organization....................... Chapter/District Outreach Reporting 135 12 5/60 135
Form.
National Office Outreach Reporting Form 2 12 20/60 8
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Total...................................... ....................................... .............. .............. .............. 1,946
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2019-10836 Filed 5-23-19; 8:45 am]
BILLING CODE 4163-18-P