60 day FRN

Federal Register / Vol. 84, No. 101 / Friday, May 24, 2019 / Notices

Agency for Toxic Substance and
Disease Registry
[60Day–19–0041; Docket No. ATSDR–2019–
0007]

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,
invites the general public and other
Federal agencies the opportunity to
comment on a proposed and/or
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 July 23, 2019.
ADDRESSES: You may submit comments,
identified by Docket No. ATSDR–2019–
0007 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Jeffrey M. Zirger, Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, MS–D74, Atlanta,
Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. ATSDR will post,
without change, all relevant comments
to Regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(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–
D74, Atlanta, Georgia 30329; phone:
404–639–7570; Email: [email protected].

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SUMMARY:

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18:10 May 23, 2019

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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
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; and
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.
5. Assess information collection costs.

SUPPLEMENTARY INFORMATION:

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Proposed Project
The National Amyotrophic Lateral
Sclerosis (ALS) Registry (OMB Control
No. 0923–0041, Expiration Date 11/30/
2019)—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 the National
Amyotrophic Lateral Sclerosis (ALS)
Registry (0923–0041, Expiration Date
11/30/2019). The current request is a
revision designed to strengthen the
usefulness of the National ALS Registry
for researchers. The changes to the ICR
include:
(1) Addition of an organized sports
participation survey to capture history

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and current participation in physical
activities. This additional survey will
take approximately 5 minutes to
complete and will add an additional 63
total burden hours for respondents;
(2) Two additional questions to
capture race and ethnicity upon
registration with other basic
demographic information will be added
to ALS Case Registration Form prior to
Persons with ALS (PALS) completing
more detailed surveys.
On October 10, 2008, President Bush
signed S.1382: ALS Registry Act which
amended the Public Health Service Act
to provide for the establishment of an
Amyotrophic Lateral Sclerosis (ALS)
Registry. The activities described are
part of the ongoing effort to maintain the
National ALS Registry.
First approved in 2010 for selfregistration, the primary goal of the
surveillance system/registry remains 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. Those interested in participating
in the National ALS Registry must
answer a series of validation questions
and if determined to be eligible they can
register.
The secondary 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. After registration,
participants complete as many as 17
voluntary survey modules, each taking
up to five minutes. In addition, in Year
1, a disease progression survey for new
registrants is completed at zero, three,
and six months. In Year 2 and Year 3,
the disease progression survey is
repeated at the yearly anniversary and at
six months. For burden estimation, the
number of disease progression survey
responses per year has been rounded up
to three times.
A biorepository component was
added in 2016 to increase the value of
the National ALS Registry to
researchers. As part of registration the
participant can request additional
information about the biorepository and
provide additional contact information.
A geographically representative sample
is selected to provide specimens. There
are two types of specimen collections,
in-home and postmortem. The in-home

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Federal Register / Vol. 84, No. 101 / Friday, May 24, 2019 / Notices
their local chapters and districts as well
as on a national level. They provide
ATSDR with information on their
outreach efforts in support of the
Registry on a monthly basis.
There are no costs to the respondents
other than their time. Participation in
this proposed information collection is
completely voluntary. The total number
of burden hours requested is 1,946
hours.

researchers and has added a respondent
type. Researchers can request access to
specimens, data, or both collected by
the National ALS Registry for their
research projects. ATSDR will review
applications for scientific validity and
human subjects’ protection and make
data/specimens available to approved
researchers. ATSDR is collaborating
with ALS service organizations to
conduct outreach activities through

collection includes blood, urine, and
saliva. The postmortem collection
includes the brain, spinal cord, cerebral
spinal fluid (CSF), bone, muscle, and
skin.
In addition to fulfilling the two-part
Congressional mandate, the Registry is
designed to be a tool for ALS
researchers. Now that the Registry has
matured, ATSDR has made data and
specimens available to approved

ESTIMATED ANNUALIZED BURDEN HOURS
Total burden
(in hours)

Form name

Person with ALS ............

ALS Case Validation Questions ..........................
ALS Case Registration Form ..............................
Voluntary Survey Modules ..................................
Disease Progression Survey* ..............................
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 ..........

1,670
1,500
750
750
325

1
1
1
3
1

2/60
10/60
85/60
5/60
30/60

56
250
1,063
188
163

350
36
24
135

1
1
1
12

10/60
30/60
15/60
5/60

59
18
6
135

National Office Outreach Reporting Form ...........

2

12

20/60

8

..............................................................................

........................

........................

........................

1,946

Researchers ..................
ALS Service Organization.
Total ........................

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–10836 Filed 5–23–19; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–19–1171; Docket No. CDC–2019–
0036]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies the opportunity to comment on
a proposed and/or continuing
information collection, as required by
the Paperwork Reduction Act of 1995.
This notice invites comment on a

SUMMARY:

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Average
burden per
response
(in hours)

No. of
responses per
respondent

No. of
respondents

Type of respondents

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19:46 May 23, 2019

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proposed information collection project
titled Study to Explore Early
Development (SEED) Phase 3. This
study evaluates potential risk factors for
Autism Spectrum Disorders (ASD) and
the behavioral and health characteristics
of children with autism by conducting
a case control study to compare them
with children who have other
developmental disabilities and children
from the general population.
DATES: CDC must receive written
comments on or before July 23, 2019.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2019–
0036 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Jeffrey M. Zirger, Lead,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS–
D74, Atlanta, Georgia 30329.
• Instructions: All submissions
received must include the agency name
and Docket Number. CDC will post,
without change, all relevant comments
to Regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(regulations.gov) or by U.S. mail to the
address listed above.
FOR FURTHER INFORMATION CONTACT: To
request more information on the

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proposed project or to obtain a contact
Jeffrey M. Zirger, Information Collection
Review Office, Centers for Disease
Control and Prevention, 1600 Clifton
Road NE, MS–D74, Atlanta, Georgia
30329; phone: 404–639–7570; 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
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;

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24MYN1