[Federal Register Volume 87, Number 189 (Friday, September 30, 2022)]
[Notices]
[Pages 59421-59424]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21219]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry
[60Day-22-0041; Docket No. ATSDR-2022-0004]
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,
[[Page 59422]]
invites the general public and other federal agencies the opportunity
to comment on a 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 November 29,
2022.
ADDRESSES: You may submit comments, identified by Docket No. ATSDR-
2022-0004 by any of the following methods:
[msqu] Federal eRulemaking Portal: www.regulations.gov. Follow the
instructions for submitting comments.
[msqu] Mail: Jeffrey M. Zirger, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE, MS H21-8, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. ATSDR will post, without change, all relevant
comments to www.regulations.gov.
Please note: Submit all comments through the Federal eRulemaking
portal (www.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 H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7118;
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 a 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;
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; and
5. Assess information collection costs.
Proposed Project
National Amyotrophic Lateral Sclerosis (ALS) Registry (OMB Control
No. 0923-0041, Exp. 01/31/2023)--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 a
Revision information collection request (ICR) titled the ``The National
Amyotrophic Lateral Sclerosis (ALS) Registry'' (OMB Control No. 0923-
0041, Exp. 01/31/2023).
In 2008, Public Law 110-373 (the ALS Registry Act) amended the
Public Health Service Act for ATSDR to: (1) develop a system to collect
data on amyotrophic lateral sclerosis ALS and other motor neuron
disorders that can be confused with ALS, misdiagnosed as ALS, or
progress to ALS; and (2) establish a national registry for the
collection and storage of such data to develop a population-based
registry of cases. Under these two mandates, ATSDR established the
National Amyotrophic Lateral Sclerosis (ALS) Registry.
The primary operational goal of the Registry is 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. The secondary operational
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.
With those goals in mind, persons with ALS first joined the
Registry in 2010. Those interested in taking part answered a series of
validation questions. If determined to be eligible, they created an
online account to enroll in the Registry. Next, they were asked to
complete up to 17 one-time voluntary survey modules, each taking up to
five minutes. New registrants were also asked to complete a
longitudinal disease progression survey (modified from the ALS
Functional Rating Scale--Revised [ALSFRS-R]) at regular intervals over
their first three years in the Registry.
A biorepository component was added in 2016. At the time of
enrollment, interested registrants can request additional information
about the biorepository and provide additional contact information.
ATSDR selects a geographically representative sample from among the
interested registrants to collect specimens. There are two types of
specimen collections, in-home and postmortem. The in-home collection
includes blood, urine, hair, nails, and saliva. The postmortem
collection includes the brain, spinal cord, cerebral spinal fluid
(CSF), bone, muscle, and skin.
Researchers can now request access to registrants' specimens, data,
or both through an ATSDR research application process. Once approved
for scientific merit, validity, and human subjects protections, ATSDR
makes the requested data and/or specimens available to the requester.
ATSDR also collaborates with ALS service organizations to conduct
outreach activities through their local chapters and districts as well
as on a national level. The service organizations provide ATSDR with
monthly reports on their outreach efforts in support of the Registry.
Under this Revision ICR, the respondent types still include persons
with ALS, researchers, and ALS service organizations. In summary, three
main revisions to the ICR are proposed.
First, based on feedback from patients, caregivers, researchers as
well as the National Center for Health Statistics (NCHS) Collaborating
Center for Questionnaire Design and Evaluation Research, ATSDR proposes
to restructure the original five-minute
[[Page 59423]]
survey modules to make them more user-friendly and easier to navigate
for patients. These changes are designed to increase completion rates
for all surveys. Therefore, ATSDR requests to restructure the layouts
of the 17 one-time ALS survey modules. The previously approved
questions in the 17 modules are reorganized into the Essential
Questionnaire and one of the four Follow-up Question modules: (1)
Demography; (2) Lifestyle Information; (3) Environmental Factors; and
(4) ALS-associated Clinical Factors. Questions determined to be
critical in capturing the information about Registry participant at the
time of enrollment is grouped as Essential Questionnaire. The remaining
questions from one-time survey are evaluated for proper classification
in the new format.
The five-minute disease progression survey requirements remain
unchanged. In Year 1, new registrants are asked to complete the disease
progression survey at zero (baseline), three, and six months. The
disease progression survey at zero (baseline) months will be
administered after completion of the Essential Questionnaire. In Year 2
and Year 3, they are asked to repeat the disease progression survey on
their anniversary date and at six months. Therefore over three years,
new registrants are requested to complete the survey seven times. For
time burden estimation, the number of responses is rounded up to three
times per year.
As a second revision, ATSDR proposes to release state level data as
four-year rolling averages for ALS incidence, prevalence, and
mortality. Case counts for the four-year moving average will only be
released for states with more than 16 ALS cases and is consistent with
United States Cancer Statistics practices where cases or deaths are
small and tend to have poor reliability.
In addition to identifying cases through Registry enrollment, ATSDR
currently identifies additional cases from three large national
administrative databases (Medicare, Veterans Health Administration, and
Veterans Benefits Administration). As a third revision, ATSDR aims to
achieve more complete ALS case ascertainment by adding several new data
sources, including state ALS registries, non-profit ALS organizations,
national ALS multidisciplinary clinics affiliated with academic
research institutions and hospital systems, and health insurance
companies and neurologists.
There is a change to the total time burden requested for persons
with ALS due to reformatting and restructuring the one-time survey
questions. This reformatting has reduced the overall time burden per
year by 188 hours from the previously approved 1,945 hours. The annual
number of responses requested is 11,549, which is an increase of 3,000
over the previously approved 8,549 responses. This increase is due to
the more accurate presentation of each online survey module in a
separate row in the burden table. Previously, the 17 online survey
modules were aggregated in a single row in the burden table. CDC
requests OMB approval for an estimated 1,757 burden hours annually.
Participation in this information collection is completely voluntary
for persons with ALS and for researchers. ALS service organizations
report their outreach information under contract with ATSDR. There are
no costs to the respondents other than their time to participate.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
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Persons with ALS.............. ALS Case 1,670 1 2/60 56
Validation
Questions.
ALS Case 1,500 1 10/60 250
Registration
Form.
Essential 750 1 6/60 75
Questionnaire.
Disease 750 3 5/60 188
Progression
Survey.
Follow-up 750 1 2/60 25
Questions--Demo
graphy.
Follow-up 750 1 32/60 400
Questions--Life
style
Information.
Follow-up 750 1 23/60 288
Questions--Envi
ronmental
Factors.
Follow-up 750 1 7/60 88
Questions--ALS-
associated and
Clinical
Factors.
ALS 325 1 30/60 162
Biorepository
Specimen
Processing Form
and In-Home
Collection.
ALS 350 1 10/60 58
Biorepository
Saliva
Collection.
Researchers................... ALS Registry 36 1 30/60 18
Research
Application
Form.
Annual Update... 24 1 15/60 6
ALS Service Organizations..... Chapter/District 135 12 5/60 135
Outreach
Reporting Form.
National Office 2 12 20/60 8
Outreach
Reporting Form.
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Total..................... ................ .............. .............. .............. 1,757
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[[Page 59424]]
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2022-21219 Filed 9-29-22; 8:45 am]
BILLING CODE 4163-70-P