60 Day FRN

Att B Published 60-day Federal Register.pdf

[NCEZID] Shigella Hypothesis Generating Questionnaire

60 Day FRN

OMB: 0920-1307

Document [pdf]
Download: pdf | pdf
45217

Federal Register / Vol. 88, No. 134 / Friday, July 14, 2023 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent
Health
Health
Health
Health
Health
Health
Health

Departments
Departments
Departments
Departments
Departments
Departments
Departments

Avg. burden
per response
(in hours)

Total annual
burden
(in hours)

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

Viral Hepatitis Case Report Form ....
APR: Component 1 ..........................
APR: Component 2 ..........................
APR: Component 3 ..........................
Supplemental APR ...........................
Initial Outbreak Report Form ...........
Outbreak Summary Report Form ....

51
59
59
20
8
59
59

381
1
1
1
1
2
2

20/60
70/60
70/60
70/60
45/60
20/60
20/60

6,412
69
69
23
6
39
39

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

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

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

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

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

6,657

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. 2023–14953 Filed 7–13–23; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–23–1307; Docket No. CDC–2023–
0058]

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
proposed information collection project
titled Shigella Hypothesis Generating
Questionnaire (SHGQ). The SHGQ
supports shigellosis cluster and
outbreak investigations. CDC will
collect state and local health department
furnished shigellosis case data.
DATES: CDC must receive written
comments on or before September 12,
2023.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2023–
0058 by either of the following methods:
• Federal eRulemaking Portal:
www.regulations.gov. Follow the
instructions for submitting comments.
SUMMARY:

lotter on DSK11XQN23PROD with NOTICES1

Number of
responses per
respondent

Number of
respondents

Form name

VerDate Sep<11>2014

17:54 Jul 13, 2023

Jkt 259001

• 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. 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.
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.

FOR FURTHER INFORMATION CONTACT:

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

SUPPLEMENTARY INFORMATION:

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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
Shigella Hypothesis Generating
Questionnaire (SHGQ) (OMB Control
No. 0920–1307, Exp. 11/30/2023)—
Extension—National Center for
Emerging and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
Shigella are a family of bacteria that
cause the diarrheal disease shigellosis. It
is estimated that Shigella causes about
450,000 cases of diarrhea in the United
States annually, with increasing
evidence of antimicrobial resistance.
From 2009 through 2021, there have
been 1,252 outbreaks of shigellosis in
the United States, with most of these
outbreaks attributed to person to person
spread. Outbreaks of shigellosis have
been reported in a range of settings such
as community-wide, daycares, schools,
restaurants, and retirement homes.
Outbreaks of shigellosis have impacted
a range of populations such as children,
men who have sex with men, people
experiencing homelessness, tight knit
religious communities, international
travelers, and refugees/displaced
persons. Finally, outbreaks of shigellosis
have been attributed to a range of

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Federal Register / Vol. 88, No. 134 / Friday, July 14, 2023 / Notices

transmission modes including personto-person/no common source, sexual
person-to person contact, contaminated
food, and contaminated water. As part
of Shigella outbreak investigations, it is
common for state and local health
departments to conduct comprehensive
interviews with cases and contacts to
identify how individuals became sick
with shigellosis, to identify individuals
who could have come into contact with
an individual sick with shigellosis, and
to identify strategies to control the
cluster or outbreak. As person-to-person
contact is the most common mode of
transmission for shigellosis, and
shigellosis is highly contagious, it can
be challenging to identify how
individuals could have become ill. As a
result, comprehensive hypothesis
generating questionnaires focused on a

exposure, work, visit, and volunteer
locations, childcare and school
attendance, and recent sexual partner(s)
and activity. This interview/survey
activity is consistent with the state’s
existing authority to investigate reports
of notifiable diseases for routine
surveillance purposes; therefore, formal
consent to participate in the activity is
not required. However, cases may
choose not to participate and may
choose not to answer any question they
do not wish to answer. It will take
health department personnel
approximately 45 minutes to administer
the questionnaire to an estimated 1,500
patient respondents. This results in an
estimated annual burden to the public
of 1,125 hours. There is no cost to
respondents other than their time to
participate.

range of settings, activities, and
potential modes of transmission are
needed to guide prevention and control
activities.
The Shigella Hypothesis Generating
Questionnaire (SHGQ) will be
administered by state and local public
health officials via telephone interviews
or self-administered web-based surveys
with cases of shigellosis or their proxy
who are part of a shigellosis cluster or
outbreak. The SHGQ will collect
information on demographics
characteristics, household information
and family member event and activity
attendance, clinical signs and
symptoms, medical care and treatment
information, travel history, contact with
international travelers or other ill
individuals, event and activity
attendance, limited food and water

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents

Shigellosis case patients identified
as part of outbreak or cluster investigations.
Total ...........................................

Shigella Hypothesis
Questionnaire.

1

45/60

1,125

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

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

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

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

1,125

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–116 and CMS–
2746]

Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:

The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995 (the
PRA), federal agencies are required to
publish notice in the Federal Register

SUMMARY:
lotter on DSK11XQN23PROD with NOTICES1

Total burden
(in hours)

1,500

[FR Doc. 2023–14955 Filed 7–13–23; 8:45 am]

18:44 Jul 13, 2023

Average
burden per
response
(in hours)

Generating

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Public Health Ethics and
Regulations, Office of Science, Centers for
Disease Control and Prevention.

VerDate Sep<11>2014

Number of
responses per
respondent

Number of
respondents

Form name

Jkt 259001

concerning each proposed collection of
information (including each proposed
extension or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
the necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions,
the accuracy of the estimated burden,
ways to enhance the quality, utility, and
clarity of the information to be
collected, and the use of automated
collection techniques or other forms of
information technology to minimize the
information collection burden.
DATES: Comments must be received by
September 12, 2023.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection

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document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number: ll, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, please access the CMS PRA
website by copying and pasting the
following web address into your web
browser: https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.
FOR FURTHER INFORMATION CONTACT:

William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:

Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).

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