[Federal Register Volume 88, Number 122 (Tuesday, June 27, 2023)]
[Notices]
[Pages 41627-41628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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

    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
----------------------------------------------------------------------------------------------------------------
                                                                                   Number of      Average burden
         Type of respondents                 Form name            Number of      responses per     per response
                                                                 respondents       respondent       (in hours)
----------------------------------------------------------------------------------------------------------------
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]
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