[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]
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