[Federal Register Volume 88, Number 134 (Friday, July 14, 2023)]
[Notices]
[Pages 45217-45218]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-14955]


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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

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: 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.
     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.

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: [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;
    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

[[Page 45218]]

transmission modes including person-to-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 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 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.

                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondents           Form name       respondents    responses per   response (in     (in hours)
                                                                    respondent        hours)
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Shigellosis case patients       Shigella                   1,500               1           45/60           1,125
 identified as part of           Hypothesis
 outbreak or cluster             Generating
 investigations.                 Questionnaire.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           1,125
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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. 2023-14955 Filed 7-13-23; 8:45 am]
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