Notice2023-00806
Agency Forms Undergoing Paperwork Reduction Act Review
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 18, 2023
Issuing agencies
Health and Human Services DepartmentAgency for Toxic Substances and Disease Registry
Full Text
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<title>Federal Register, Volume 88 Issue 11 (Wednesday, January 18, 2023)</title>
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[Federal Register Volume 88, Number 11 (Wednesday, January 18, 2023)]
[Notices]
[Pages 2918-2919]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-00806]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry
[30Day-23-0041]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Agency
for Toxic Substances and Disease Registry (ATSDR) has submitted the
information collection request titled the ``National Amyotrophic
Lateral Sclerosis (ALS) Registry'' to the Office of Management and
Budget (OMB) for review and approval. ATSDR previously published a
``Proposed Data Collection Submitted for Public Comment and
Recommendations'' notice on September 30, 2022, to obtain comments from
the public and affected agencies. ATSDR received one comment related to
the previous notice. This notice serves to allow an additional 30 days
for public and affected agency comments.
ATSDR will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(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. Comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. Direct
written comments and/or suggestions regarding the items contained in
this notice to the Attention: CDC Desk Officer, Office of Management
and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202)
395-5806. Provide written comments within 30 days of notice
publication.
Proposed Project
National Amyotrophic Lateral Sclerosis (ALS) Registry (OMB Control
No. 0923-0041, Exp. 1/31/2023)--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 ``National
Amyotrophic Lateral Sclerosis (ALS) Registry'' (OMB Control No. 0923-
0041, Exp. Date 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 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 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
[[Page 2919]]
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 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) Demographics; (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 are grouped in the Essential Questionnaire.
The remaining questions from one-time survey were 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 0 (baseline), three, and six months. The disease
progression survey at 0 (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 new data sources
(totaling less than nine), including state ALS registries and non-
profit ALS organizations.
There are no costs to the respondents other than their time. 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 time burden per year to 1,757 hours, which
is a decrease of 188 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.
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.
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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Persons with ALS...................... ALS Case Validation 1,670 1 2/60
Questions.
ALS Case Registration 1,500 1 10/60
Form.
Essential Questionnaire. 750 1 6/60
Disease Progression 750 3 5/60
Survey.
Follow-up Questions-- 750 1 2/60
Demography.
Follow-up Questions-- 750 1 32/60
Lifestyle Information.
Follow-up Questions-- 750 1 23/60
Environmental Factors.
Follow-up Questions--ALS- 750 1 7/60
associated and Clinical
Factors.
ALS Biorepository 325 1 30/60
Specimen Processing
Form and In-Home
Collection.
ALS Biorepository Saliva 350 1 10/60
Collection.
Researchers........................... ALS Registry Research 36 1 30/60
Application Form.
Annual Update........... 24 1 15/60
ALS Service Organizations............. Chapter/District 135 12 5/60
Outreach Reporting Form.
National Office Outreach 2 12 20/60
Reporting Form.
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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. 2023-00806 Filed 1-17-23; 8:45 am]
BILLING CODE 4163-70-P
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