60 Day FRN

43351

Federal Register / Vol. 88, No. 129 / Friday, July 7, 2023 / Notices
multiple challenges, including the need
to have high-quality hypothesisgenerating questionnaire(s) that can be
used effectively in multijurisdictional
investigations. Such a questionnaire was
developed in the past for use in the
context of foodborne outbreaks caused
by bacterial pathogens; that
questionnaire is referred to as the
Standardized National Hypothesis
Generating Questionnaire (SNHGQ).
However, not all of the data elements in
the SNHGQ are relevant to the parasite
Cyclospora (e.g., questions about
consumption of meat and dairy
products); on the other hand, additional
data elements (besides those in the
SNHGQ) are needed to capture
information pertinent to Cyclospora and
to fresh produce vehicles of infection.
Therefore, the Cyclosporiasis National
Hypothesis Generating Questionnaire
(CNHGQ) has been developed, by using

core data elements from the SNHGQ and
incorporating modifications pertinent to
Cyclospora.
The core data elements from the
SNHGQ were developed by a series of
working groups comprised of local,
state, and Federal public health
partners. Subject matter experts at CDC
developed the CNHGQ by modifying the
SNHGQ to include and focus on data
elements pertinent to Cyclospora/
cyclosporiasis. Input also was solicited
from state public health partners.
Because relatively few data elements in
the SNHGQ needed to be modified, a
full vetting process was determined not
to be necessary. The CNHGQ has been
designed for administration over the
telephone by public health officials, to
collect data elements from case-patients
or their proxies. The data that are
collected will be pooled and analyzed at

CDC, to generate hypotheses about
potential vehicles/sources of infection.
CDC requests OMB approval to collect
information via the CNHGQ from
persons who have developed
symptomatic cases of Cyclospora
infection during periods in which
increased numbers of such cases are
reported (typically, during spring and
summer months). In part because
molecular typing methods are not yet
available for C. cayetanensis, it is
important to interview all case-patients
identified during periods of increased
reporting, to help determine if their
cases could be part of an outbreak(s).
The CNHGQ is not expected to entail
substantial burden for respondents. The
estimated total annualized burden
associated with administering the
CNHGQ is 1,875 hours. There will be no
costs to respondents other than their
time.

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents

Ill individuals identified with cyclosporiasis .........

Cyclosporiasis National Hypothesis Generating
Questionnaire.

Total ..............................................................

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

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Public Health Ethics and
Regulations, Office of Science, Centers for
Disease Control and Prevention.
[FR Doc. 2023–14414 Filed 7–6–23; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–23–23GL; Docket No. CDC–2023–
0055]

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.
ddrumheller on DSK120RN23PROD with NOTICES1

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

SUMMARY:

VerDate Sep<11>2014

18:55 Jul 06, 2023

Number of
respondents

Form name

Jkt 259001

Frm 00089

Fmt 4703

Sfmt 4703

Total burden
(in hours)

1

45/60

1,875

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

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

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

1,875

You may submit comments,
identified by Docket No. CDC–2023–
0055 by either of the following methods:
• Federal eRulemaking Portal:
www.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 H21–8, Atlanta,
Georgia 30329.
Instructions: All submissions received
must include the agency name and

PO 00000

Average
burden per
response
(in hours)

2,500

information collection, as required by
the Paperwork Reduction Act of 1995.
This notice invites comment on a
proposed information collection project
titled National Wastewater Surveillance
System for COVID–19 and other
infectious disease targets of public
health concern. The proposed
information collection project aims to
collect pathogen and public health
target concentration in wastewater,
wastewater target variant sequencing
data, sewershed spatial files, and
associated sewershed-level case data
from participating jurisdictions in the
United States to inform infectious
disease prevention and control efforts.
DATES: CDC must receive written
comments on or before September 5,
2023.
ADDRESSES:

Number of
responses per
respondent

Docket Number. CDC 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: 404–639–7570; Email: omb@
cdc.gov.
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

E:\FR\FM\07JYN1.SGM

07JYN1

43352

Federal Register / Vol. 88, No. 129 / Friday, July 7, 2023 / Notices

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 Wastewater Surveillance
System for SARS–CoV–2 and other
infectious disease targets of public
health concern—New—National Center
for Emerging and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).

ddrumheller on DSK120RN23PROD with NOTICES1

Background and Brief Description
This information collection request is
built upon a project currently approved
under the COVID–19 Public Health
Emergency (PHE) PRA Waiver. This
expanded information collection request
is for three years. The COVID–19
pandemic has demonstrated the need
for timely, actionable surveillance data
to inform disease prevention and
control activities. The genetic material
of SARS–CoV–2, the virus that causes
COVID–19, has been detected in the
feces of infected individuals, regardless
of their symptom status. Therefore,
sampling and testing wastewater
provides a means to assess SARS–CoV–
2 infection trends in the community
independent of clinical testing or other
healthcare indicators. This public health
surveillance approach can be used for
other infectious diseases or targets, such
as mpox, influenza, and antimicrobial
resistance. Recommendations for
wastewater data collection for specific
infectious diseases will be based on

VerDate Sep<11>2014

18:55 Jul 06, 2023

Jkt 259001

public health need and input from the
NWSS Advisory Council comprised of
subject matter experts from across CDC.
The Waterborne Disease Prevention
Branch (WDPB) in the Division of
Foodborne, Waterborne, and
Environmental Diseases works to
prevent domestic and global water,
sanitation, and hygiene related disease.
In support of the Centers for Disease
Control and Prevention (CDC) COVID–
19 response, WDPB established the
National Wastewater Surveillance
System (NWSS). NWSS serves as a
public health tool to provide wastewater
surveillance of SARS–CoV–2 infections.
In 2022, NWSS was expanded to
include environmental surveillance of
mpox infections. NWSS was designed to
permit the addition or exchange of
targets for wastewater infectious disease
testing. This built-in flexibility will
allow jurisdictions to adapt wastewater
testing to changing public health needs,
enable rapid responses to outbreaks or
emergencies, and support broad
capacity to detect future disease threats.
Wastewater data have provided
impactful information to local public
health authorities, whether to confirm
trends observed in testing or
hospitalization rates, or to assert the
need for increased testing or healthcare
resources. NWSS has supported
jurisdictions throughout the United
States to implement wastewater
surveillance, and will continue to
support state, tribal, local, and territorial
(STLT) partners to collect wastewater
data. Together with CDC-funded
national-level wastewater testing,
jurisdictions across the U.S. have
submitted data to NWSS that represents
approximately 138 million individuals,
or 41% of the U.S. population. Data are
input to the Data Collation and
Integration for Public Health Event
Response (DCIPHER) platform for
participants to view and analyze in near
real time.
Wastewater surveillance provides
aggregated, anonymized data at the
community level to indicate trends in
infections. These data can be especially
impactful in underserved populations
where clinical testing is limited or
health care seeking is reduced.
Wastewater data collection could inform
locations that require greater resource
allocation early in outbreaks and
provide health departments with
additional surveillance data to assess
community-level infection trends.
Wastewater data collection will be
coordinated by health department
jurisdictions through close collaboration
with wastewater utilities, testing

PO 00000

Frm 00090

Fmt 4703

Sfmt 4703

laboratories, and by CDC through
national-level testing contracts that
cover up to 500 wastewater utility sites.
There are three data components
comprising this collection request. For
data collection Component 1,
wastewater utilities or partners will
collect single time point, time-weighted
composite, or flow-weighted composite
samples from wastewater influent lines
or at other points in the collection
stream at regular intervals, such as once
a week. The wastewater samples will be
shipped, along with their associated
sampling metadata, to testing
laboratories where pathogen- or targetspecific RNA or DNA will be quantified
for up to 30 targets (e.g., SARS–CoV–2,
mpox, influenza, antibiotic resistance,
etc.). For some wastewater samples,
target sequencing will be conducted to
help public health officials monitor
infectious disease variant trends (e.g.,
SARS–CoV–2). The testing laboratory
will deliver wastewater sample
collection and laboratory testing data to
the jurisdiction health department, or
directly to the CDC from national-level
testing, to compile, review, and submit
to CDC through the NWSS DCIPHER
platform.
For data collection Component 2,
jurisdiction health departments will
work with participating utilities to
obtain spatial files of the utility service
areas, also called a sewershed. These
sewershed spatial files will be uploaded
by jurisdiction health departments into
the NWSS DCIPHER platform.
For data collection Component 3,
health department jurisdictions may
choose to develop a line list of reported
cases of specific infections (e.g.,
COVID–19, mpox, influenza, antibiotic
resistant infections, etc.) associated with
the participating wastewater utility
service areas. The health department
jurisdiction will submit to CDC the line
list of deidentified cases into the NWSS
DCIPHER platform.
The proposed data collection will
occur over three years. Based on
previous pilot data collection and
additional estimates from 2022–2023
U.S. case numbers in the CDC National
Notifiable Disease Surveillance System
(NNDSS), it is estimated that 166,400
wastewater samples and 2,198,736
sewershed-level case data files will be
collected and reported to NWSS each
year, while 1,100 sewershed spatial files
will only need to be submitted once
during the three-year period. In total,
the estimated annual burden for all data
collection components for this request is
571,013 hours.

E:\FR\FM\07JYN1.SGM

07JYN1

43353

Federal Register / Vol. 88, No. 129 / Friday, July 7, 2023 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents

State, tribal, local, territorial
health departments.

Private laboratory .....................

State, tribal, local, territorial
health departments.
Wastewater utilities ..................
State, tribal, local, territorial
health departments.

Total ..................................

Component 1 Forms: NWSS Data Dictionary
v5.0.0; CDC Seq Manifest Data Dictionary;
BioSample_WW Template v1.9; SRA Template v5.7 NWSS; NCBI DCIPHER Crosswalk_Data Dictionary; NWSS_DCIPHER
Wastewater Data CSV Upload Template;
Component 1–2–3 NWSS DCIPHER CSV
Bulk Upload Tool.
Component 1 Forms: Component; NWSS Data
Dictionary v5.0.0; CDC Seq Manifest Data
Dictionary; BioSample WW Template v1.9;
SRA WW Template v5.7; NCBI DCIPHER
Crosswalk Data Dictionary; NWSS
DCIPHER Wastewater Data CSV Upload
Template v3; Component 1–2–3 NWSS
DCIPHER CSV Bulk Upload Tool.
Component 2 Forms: Sewershed Spatial Files
(No Form); Component 1–2–3 NWSS
DCIPHER CSV Bulk Upload Tool.
Component 2 Forms: Sewershed Spatial Files
(No Form); Component 1–2–3 NWSS
DCIPHER CSV Bulk Upload Tool.
Component 3 Forms: NWSS COVID Case
Data Dictionary; NWSS DCIPHER Case
Data CSV Upload Template; NWSS
DCIPHER Sewershed Name Crosswalk
CSV Upload Template; Component_1–2–3
NWSS DCIPHER CSV Bulk Upload Tool.
...........................................................................

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Public Health Ethics and
Regulations, Office of Science, Centers for
Disease Control and Prevention.
[FR Doc. 2023–14413 Filed 7–6–23; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–23–1204]

ddrumheller on DSK120RN23PROD with NOTICES1

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 ‘‘Behavioral
Risk Factor Surveillance System
(BRFSS) Asthma Call-back Survey
(ACBS)’’ 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 March 6,
2023 to obtain comments from the

VerDate Sep<11>2014

18:55 Jul 06, 2023

Jkt 259001

Frm 00091

Fmt 4703

Sfmt 4703

Average
burden per
response
(in hours)

Total
annual
burden
hours

55

2,080

139/60

265,026

1

52,000

139/60

120,467

55

20

5/60

92

1,100

1

2

2,200

55

39,977

5/60

183,228

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

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

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

571,013

public and affected agencies. CDC did
not receive 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

PO 00000

Number of
responses per
respondent

Number of
respondents

Form name

(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 ‘‘http://www.reginfo.gov/
public/doPRAMain’’. 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
Behavioral Risk Factor Surveillance
System (BRFSS) Asthma Call-back
Survey (ACBS) (OMB Control No. 0920–
1204, Expiration Date 11/30/2023)—
Revision—National Center for
Environmental Health (NCEH), Centers
for Disease Control and Prevention
(CDC).

E:\FR\FM\07JYN1.SGM

07JYN1