Proposed Data Collection Submitted for Public Comment and Recommendations, 59421-59424 [2022-21219]
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Federal Register / Vol. 87, No. 189 / Friday, September 30, 2022 / Notices
FEDERAL RESERVE SYSTEM
jspears on DSK121TN23PROD with NOTICES
Change in Bank Control Notices;
Acquisitions of Shares of a Bank or
Bank Holding Company
The notificants listed below have
applied under the Change in Bank
Control Act (Act) (12 U.S.C. 1817(j)) and
§ 225.41 of the Board’s Regulation Y (12
CFR 225.41) to acquire shares of a bank
or bank holding company. The factors
that are considered in acting on the
applications are set forth in paragraph 7
of the Act (12 U.S.C. 1817(j)(7)).
The public portions of the
applications listed below, as well as
other related filings required by the
Board, if any, are available for
immediate inspection at the Federal
Reserve Bank(s) indicated below and at
the offices of the Board of Governors.
This information may also be obtained
on an expedited basis, upon request, by
contacting the appropriate Federal
Reserve Bank and from the Board’s
Freedom of Information Office at
https://www.federalreserve.gov/foia/
request.htm. Interested persons may
express their views in writing on the
standards enumerated in paragraph 7 of
the Act.
Comments regarding each of these
applications must be received at the
Reserve Bank indicated or the offices of
the Board of Governors, Ann E.
Misback, Secretary of the Board, 20th
Street and Constitution Avenue NW,
Washington, DC 20551–0001, not later
than October 17, 2022.
A. Federal Reserve Bank of
Minneapolis (Chris P. Wangen,
Assistant Vice President) 90 Hennepin
Avenue, Minneapolis, Minnesota
55480–0291:
1. Mark Jon Vis, Worthington,
Minnesota; to acquire voting shares of
First Rushmore Bancorporation, Inc.,
Worthington, Minnesota, and thereby
indirectly acquire voting shares of First
State Bank Southwest, Pipestone,
Minnesota, by becoming a co-trustee of
the First State Bank Southwest KSOP
Plan and Trust, Worthington,
Minnesota.
B. Federal Reserve Bank of Dallas
(Karen Smith, Director, Applications)
2200 North Pearl Street, Dallas, Texas
75201–2272:
1. The Linda Lewis McSween Trust
fbo Paul E. McSween III, Paul E.
McSween III, as trustee, the Linda Lewis
McSween Trust fbo Linda McSween
Satel, Linda McSween Satel, as trustee,
the Linda Lewis McSween Trust fbo
Juliet McSween Zacher, Juliet McSween
Zacher, as trustee, and the Linda Lewis
McSween Trust fbo Jennifer McSween
Canavan, Jennifer McSween Canavan,
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as trustee, all of San Antonio, Texas; to
join the McSween Family Control
Group, a group acting in concert, to
retain voting shares of Jefferson
Bancshares, Inc., and thereby indirectly
retain voting shares of Jefferson Bank,
both of San Antonio, Texas.
Board of Governors of the Federal Reserve
System.
Michele Taylor Fennell,
Deputy Associate Secretary of the Board.
[FR Doc. 2022–21307 Filed 9–29–22; 8:45 am]
BILLING CODE P
FEDERAL TRADE COMMISSION
Privacy Act of 1974; System of
Records
Federal Trade Commission.
Rescindment of a system of
records notice.
AGENCY:
ACTION:
The Federal Trade
Commission (FTC or Commission) is
issuing a public notification of its intent
to rescind the Privacy Act System of
Records Notice (SORN) on the Staff
Time and Activity Reporting (STAR)
System–FTC (FTC–II–13) and remove it
from its existing inventory of SORNs.
DATES: This change is effective on
September 30, 2022.
ADDRESSES: Interested parties may file a
comment online or on paper. Write
‘‘Privacy Act SORN Rescindment’’ on
your comment and file your comment
online at https://www.regulations.gov by
following the instructions on the webbased form. If you prefer to file your
comment on paper, mail your comment
to the following address: Federal Trade
Commission, Office of the Secretary,
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CC–5610 (Annex J), Washington, DC
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containing material for which
confidential treatment is requested must
be filed in paper form, must be clearly
labeled ‘‘Confidential,’’ and must
comply with FTC Rule 4.9(c), 16 CFR
4.9(c).
FOR FURTHER INFORMATION CONTACT: G.
Richard Gold, Attorney, Office of the
General Counsel, FTC, 600
Pennsylvania Avenue NW, Washington,
DC 20580, (202–326–3355).
SUPPLEMENTARY INFORMATION: Pursuant
to the provisions of the Privacy Act of
1974, as amended, 5 U.S.C. 552a, the
FTC is rescinding the Staff Time and
Activity Reporting (STAR) System–FTC
SUMMARY:
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59421
(FTC–II–13) system of records notice
and removing it from its system of
records inventory. During a review of
agency SORNs, the Commission
determined that the STAR SORN was
written to describe a database that has
been decommissioned and no longer
exists.
The STAR System combined matter
data as well as time and attendance data
for FTC employees. The FTC will
continue to separately maintain matterrelated data in its Matter Management
System (FTC–I–5) about individual
employee participation in such matters,
and also maintain employee time and
attendance data in its employee payroll
system (FTC–III–1).
This rescindment will eliminate an
unnecessary duplicate notice and
ensure compliance with the Privacy Act
of 1974 and the Office of Management
and Budget (OMB) Circular A–108,
Federal Agency Responsibilities for
Review, Reporting, and Publication
under the Privacy Act. Rescinding the
STAR SORN will have no adverse
impacts on individuals and will also
promote the overall streamlining and
management of FTC Privacy Act
systems of records.
SYSTEM NAME AND NUMBER:
Staff Time and Activity Reporting
(STAR) System—FTC (FTC–II–13).
HISTORY:
85 FR 16349, 16352–53 (March 23,
2020).
By direction of the Commission.
April J. Tabor,
Secretary.
[FR Doc. 2022–21250 Filed 9–29–22; 8:45 am]
BILLING CODE 6750–01–P
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 for Toxic Substances
and Disease Registry (ATSDR),
Department of Health and Human
Services (HHS).
ACTION: Notice with comment period.
AGENCY:
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,
SUMMARY:
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Federal Register / Vol. 87, No. 189 / Friday, September 30, 2022 / Notices
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
ADDRESSES: You may submit comments,
collection of information on those who
identified by Docket No. ATSDR–2022– are to respond, including through the
0004 by any of the following methods:
use of appropriate automated,
Ÿ Federal eRulemaking Portal:
electronic, mechanical, or other
www.regulations.gov. Follow the
technological collection techniques or
instructions for submitting comments.
other forms of information technology,
Ÿ Mail: Jeffrey M. Zirger, Information e.g., permitting electronic submissions
of responses; and
Collection Review Office, Centers for
5. Assess information collection costs.
Disease Control and Prevention, 1600
Clifton Road NE, MS H21–8, Atlanta,
Proposed Project
Georgia 30329.
National Amyotrophic Lateral
Instructions: All submissions received
Sclerosis (ALS) Registry (OMB Control
must include the agency name and
No. 0923–0041, Exp. 01/31/2023)—
Docket Number. ATSDR will post,
Revision—Agency for Toxic Substances
without change, all relevant comments
and Disease Registry (ATSDR).
to www.regulations.gov.
Please note: Submit all comments
Background and Brief Description
through the Federal eRulemaking portal
The Agency for Toxic Substances and
(www.regulations.gov) or by U.S. mail to
Disease
Registry (ATSDR) is requesting
the address listed above.
a three-year Paperwork Reduction Act
FOR FURTHER INFORMATION CONTACT: To
(PRA) clearance for a Revision
request more information on the
information collection request (ICR)
proposed project or to obtain a copy of
titled the ‘‘The National Amyotrophic
the information collection plan and
Lateral Sclerosis (ALS) Registry’’ (OMB
instruments, contact Jeffrey M. Zirger,
Control No. 0923–0041, Exp. 01/31/
Information Collection Review Office,
2023).
Centers for Disease Control and
In 2008, Public Law 110–373 (the ALS
Prevention, 1600 Clifton Road NE, MS
Registry Act) amended the Public
H21–8, Atlanta, Georgia 30329;
Health Service Act for ATSDR to: (1)
Telephone: 404–639–7118; Email: omb@ develop a system to collect data on
cdc.gov.
amyotrophic lateral sclerosis ALS and
SUPPLEMENTARY INFORMATION: Under the
other motor neuron disorders that can
Paperwork Reduction Act of 1995 (PRA) be confused with ALS, misdiagnosed as
(44 U.S.C. 3501–3520), federal agencies
ALS, or progress to ALS; and (2)
must obtain approval from the Office of
establish a national registry for the
Management and Budget (OMB) for each collection and storage of such data to
collection of information they conduct
develop a population-based registry of
or sponsor. In addition, the PRA also
cases. Under these two mandates,
requires federal agencies to provide a
ATSDR established the National
60-day notice in the Federal Register
Amyotrophic Lateral Sclerosis (ALS)
concerning each proposed collection of
Registry.
The primary operational goal of the
information, including each new
Registry is to obtain reliable information
proposed collection, each proposed
on the incidence and prevalence of ALS,
extension of existing collection of
and to better describe the demographic
information, and each reinstatement of
characteristics (age, race, sex, and
a previously approved information
geographic location) of persons with
collection before submitting the
ALS. The secondary operational goal of
collection to the OMB for approval. To
the surveillance system/Registry is to
comply with this requirement, we are
collect additional information on
publishing this notice of a proposed
potential risk factors for ALS, including,
data collection as described below.
jspears on DSK121TN23PROD with NOTICES
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.
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18:52 Sep 29, 2022
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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
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Federal Register / Vol. 87, No. 189 / Friday, September 30, 2022 / Notices
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 onetime 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) ALSassociated 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
Average
burden per
response
(in hours)
Total burden
(in hours)
Form name
Persons with ALS .............................
ALS Case Validation Questions .......
ALS Case Registration Form ...........
Essential Questionnaire ...................
Disease Progression Survey ............
Follow-up Questions—Demography
Follow-up Questions—Lifestyle Information.
Follow-up
Questions—Environmental Factors.
Follow-up Questions—ALS-associated and Clinical Factors.
ALS Biorepository Specimen Processing Form and In-Home Collection.
ALS Biorepository Saliva Collection
ALS Registry Research Application
Form.
Annual Update .................................
Chapter/District Outreach Reporting
Form.
National Office Outreach Reporting
Form.
1,670
1,500
750
750
750
750
1
1
1
3
1
1
2/60
10/60
6/60
5/60
2/60
32/60
56
250
75
188
25
400
750
1
23/60
288
750
1
7/60
88
325
1
30/60
162
350
36
1
1
10/60
30/60
58
18
24
135
1
12
15/60
5/60
6
135
2
12
20/60
8
...........................................................
........................
........................
........................
1,757
Researchers ......................................
ALS Service Organizations ...............
Total ...........................................
jspears on DSK121TN23PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
Type of respondents
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Federal Register / Vol. 87, No. 189 / Friday, September 30, 2022 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day-22–1083]
jspears on DSK121TN23PROD with NOTICES
Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled ‘‘Extended
Evaluation of the National Tobacco
Prevention and Control Public
Education Campaign’’ to the Office of
Management and Budget (OMB) for
review and approval. CDC previously
published a ‘‘Proposed Data Collection
Submitted for Public Comment and
Recommendations’’ notice on June 2,
2022 to obtain comments from the
public and affected agencies. CDC
received two comments related to the
previous notice. This notice serves to
allow an additional 30 days for public
and affected agency comments.
CDC 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
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18:52 Sep 29, 2022
Jkt 256001
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
Extended Evaluation of the National
Tobacco Prevention and Control Public
Education Campaign (OMB Control No.
0920–1083, Exp. 3/31/2023)—
Revision—National Center for Chronic
Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
In 2012, HHS/CDC launched the
National Tobacco Prevention and
Control Public Education Campaign
(Tips). The primary objectives of Tips
are to encourage smokers to quit
smoking and to encourage nonsmokers
to communicate with smokers about the
dangers of smoking. Tips airs annually
in all U.S. media markets on broadcast
and national cable TV as well as other
media channels including digital video,
online display and banners, radio,
billboards, and other formats. Tips ads
rely on evidence-based paid media
advertising that highlights the negative
health consequences of smoking. Tips’
primary target audience is adult
smokers; adult nonsmokers constitute
the secondary audience. Tips paid
advertisements are aimed at providing
motivation and support to smokers to
quit, with information and other
resources to increase smokers’ chances
of success in their attempts to quit
smoking. A key objective for the
nonsmoker audience is to encourage
nonsmokers to communicate with
smokers they may know (including
family and friends) about the dangers of
smoking and to encourage them to quit.
Tips ads also focus on increasing
audience’s knowledge of smokingrelated diseases, intentions to quit, and
other related outcomes.
The goal of the proposed information
collection is to evaluate the reach of
Tips among intended audiences and to
examine the effectiveness of these
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efforts in impacting specific outcomes
that are targeted by Tips, including quit
attempts and intentions to quit among
smokers, nonsmokers’ communications
about the dangers of smoking, and
knowledge of smoking-related diseases
among both audiences. This will require
customized surveys that will capture all
unique messages and components of
Tips. Information will be collected
through Web surveys to be selfadministered by adults 18 and over on
computers in the respondent’s home or
in another convenient location.
Evaluating Tips’ impact on behavioral
outcomes is necessary to determine
campaign cost effectiveness and to
allow program planning for the most
effective campaign outcomes. Because
Tips content changes, it is necessary to
evaluate each yearly implementation of
Tips.
The proposed information collection
will include three survey collections per
year (nine surveys in total) generally
conducted before, during, and after Tips
in each year. Using the same methods
outlined in the currently approved
information collection (OMB Control
No. 0920–1083, Exp. 3/31/2023),
participants will be recruited from two
sources: (1) an online longitudinal
cohort of adult smokers and
nonsmokers, sampled randomly from
postal mailing addresses in the United
States (address-based sample, or ABS);
and (2) the existing Ipsos
KnowledgePanel, an established longterm online panel of U.S. adults. All
online surveys, regardless of sample
source, will be conducted via the GfK/
Ipsos KnowledgePanel Web portal for
self-administered surveys.
Information will be collected about
smokers’ and nonsmokers’ awareness of
and exposure to specific Tips
advertisements; knowledge, attitudes,
beliefs related to smoking and
secondhand smoke; and other marketing
exposure. The surveys will also measure
behaviors related to smoking cessation
(among the smokers in the sample) and
behaviors related to nonsmokers’
encouragement of smokers to quit
smoking, recommendations of cessation
services, and attitudes about other
tobacco and nicotine products.
It is important to evaluate Tips in a
context that assesses the dynamic nature
of tobacco product marketing and
uptake of various tobacco products,
particularly since these may affect
successful cessation rates. Survey
instruments may be updated to include
new or revised items on relevant topics,
including cigars, noncombustible
tobacco products, and other emerging
trends in tobacco use.
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[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
