[Federal Register Volume 88, Number 11 (Wednesday, January 18, 2023)]
[Notices]
[Pages 2918-2919]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 www.reginfo.gov/public/do/PRAMain. 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
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
          Type of respondents                   Form name           respondents    responses per   response (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
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