[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]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
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.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           1,757
----------------------------------------------------------------------------------------------------------------



[[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