[Federal Register Volume 85, Number 149 (Monday, August 3, 2020)]
[Notices]
[Pages 46630-46631]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16796]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-20-20HD]


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 Shigella Hypothesis Generating Questionnaire 
(SHGQ) 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 February 
25, 2020 to obtain comments from the public and affected agencies. CDC 
received two 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
    (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 www.reginfo.gov/public/do/PRAMain 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

    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.

[[Page 46631]]



                                        Estimated Annualized Burden Hours
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                                                                                   Number of      Average burden
         Type of respondents                 Form name            Number of      responses per     per response
                                                                 respondents       respondent       (in hours)
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Shigellosis case patients identified  Shigella Hypothesis                1500                1            45/60
 as part of outbreak or cluster        Generating
 investigations.                       Questionnaire.
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2020-16796 Filed 7-31-20; 8:45 am]
BILLING CODE 4163-18-P