[Federal Register Volume 85, Number 37 (Tuesday, February 25, 2020)]
[Notices]
[Pages 10692-10693]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03650]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-20-20HD; Docket No. CDC-2020-0010]


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 development of a Shigella Hypothesis 
Generating Questionnaire will support 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 April 27, 2020.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2020-
0010 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. 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 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact Jeffrey M. Zirger, of the 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:

[[Page 10693]]

    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.

Proposed Project

    Shigella Hypothesis Generating Questionnaire--New--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 500,000 cases 
of diarrhea in the United States annually. From 2007 through 2017, 
there have been 1,046 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 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.
    There is currently no national, standardized hypothesis generating 
interview data collection instrument for use during single or 
multistate shigellosis cluster or outbreak investigations. More 
detailed data about shigellosis cases involved in single or multistate 
clusters or outbreaks are needed to better characterize the 
epidemiology of clusters and outbreaks and to identify modes or 
settings of importance by collecting the following information. This 
information will not only help inform routine cluster and outbreak 
investigation activities but also guide awareness efforts and 
appropriate prevention strategies. To meet these needs the Shigella 
Hypothesis Generating Questionnaire (SHGQ) was developed.
    The SHGQ will be administered by state and local public health 
officials via telephone interviews 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 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 1500 patient respondents. 
This results in an estimated annual burden to the public of 1,125 
hours.

                                        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.
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    Total.....................  ................  ..............  ..............  ..............           1,125
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2020-03650 Filed 2-24-20; 8:45 am]
 BILLING CODE 4163-18-P