Notice2023-13568
Agency Forms Undergoing Paperwork Reduction Act Review
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 27, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 88 Issue 122 (Tuesday, June 27, 2023)</title>
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[Federal Register Volume 88, Number 122 (Tuesday, June 27, 2023)]
[Notices]
[Pages 41627-41628]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-13568]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-23-0997]
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 ``Standardized National Hypothesis Generating
Questionnaire'' 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 March 10,
2023 to obtain comments from the public and affected agencies. CDC
received two non-substantive 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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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
Standard National Hypothesis Generating Questionnaire (OMB Control
No. 0920-0997)--Reinstatement--National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
It is estimated that each year roughly one in six Americans get
sick, 128,000 are hospitalized, and 3,000 die of foodborne diseases.
CDC and partners ensure rapid and coordinated surveillance, detection,
and response to multistate outbreaks, to limit the number of these
illnesses, and to learn how to prevent similar outbreaks from happening
in the future.
Conducting interviews during the initial hypothesis-generating
phase of multistate foodborne disease outbreaks presents numerous
challenges. In the United States there is not a standard, national form
or data collection system for illnesses caused by many enteric
pathogens. Data elements for hypothesis generation must be developed
and agreed upon for each investigation. This process can take several
days to weeks and may cause interviews to occur long after a person
becomes ill.
CDC requests a Reinstatement of this project, called the
Standardized National Hypothesis-Generating Questionnaire, to collect
standardized information from individuals who have become ill during a
multistate foodborne disease event. Since the questionnaire is designed
to be administered by public health officials as part of multistate
hypothesis-generating interview activities, this questionnaire is not
expected to entail significant burden to respondents.
The Standardized National Hypothesis-Generating Core Elements
Project was established with the goal to define a core set of data
elements to be used for hypothesis generation during multistate
foodborne investigations. These elements represent information that
should be available for all outbreak-associated cases identified during
hypothesis generation. The core elements would ensure that similar
exposures would be ascertained across many jurisdictions, allowing for
rapid pooling of data to improve the timeliness of hypothesis-
generating analyses and to shorten the time to pinpoint how and where
contamination events occur.
The Standardized National Hypothesis Generating Questionnaire
[[Page 41628]]
(SNHGQ) was designed as a data collection tool for the core elements,
to be used when a multistate cluster of enteric disease infections is
identified. The questionnaire is designed to be administered over the
phone by public health officials to collect core elements data from
case-patients or their proxies. Both the content of the questionnaire
(the core elements) and the format were developed through a series of
working groups comprised of local, state, and federal public health
partners.
Since the last revision of the SNHGQ in 2019, CDC has investigated
over 470 possible multistate foodborne and enteric clusters of
infection involving over 26,000 ill people. Of which, an outbreak
vehicle has been identified in 199 of these investigations. These
outbreaks have led to many recalls and countless regulatory actions
that have removed millions of pounds of contaminated vehicles out of
commerce. In almost all instances, the SNHGQ or iterations of the SNHGQ
have been instrumental in the successful investigation of these
outbreaks. The questionnaire has allowed investigators to more
efficiently and effectively interview ill persons as they are
identified. Because these exposures are captured in a common, standard
format, we have been able to share and analyze data rapidly across
jurisdictional lines. Faster interview response and analysis times have
allowed for more rapid epidemiologic investigation and quicker
regulatory action, thus helping to prevent thousands of additional
illnesses from occurring and spurring industry to adopt and implement
new food safety measures in an effort to prevent future outbreaks.
The total estimated annualized burden requested is 3,000 hours
(approximately 4,000 individuals identified during the hypothesis-
generating phase of outbreak investigations with 45 minutes/response).
There are no costs to respondents other than their time.
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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Ill individuals identified as part Standardized National 4,000 1 45/60
of an outbreak investigation. Hypothesis Generating
Questionnaire.
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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. 2023-13568 Filed 6-26-23; 8:45 am]
BILLING CODE 4163-18-P
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