[Federal Register Volume 90, Number 112 (Thursday, June 12, 2025)]
[Notices]
[Pages 24798-24800]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-10724]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-25-24EE]
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 ``Division of Foodborne, Waterborne, and
Environmental Diseases (DFWED) National Hypothesis Generation and
Investigation Module'' 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
April 5, 2024 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.
[[Page 24799]]
Proposed Project
Division of Foodborne, Waterborne, and Environmental Diseases
(DFWED) National Hypothesis Generation and Investigation Module--New--
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID),
Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The Division of Foodborne, Waterborne, and Environmental Diseases
(DFWED) at the Centers for Disease Control and Prevention (CDC) aims to
protect public health through the prevention and control of disease,
disability, and death caused by foodborne, enteric, waterborne, and
environmentally transmitted infections. To overcome challenges
presented by the changing landscape of enteric diseases, the need for
comprehensive hypothesis generating questionnaires focused on a range
of settings, activities, and potential modes of transmission are
essential to guide prevention and control activities. The submitted
forms standardize hypothesis generating instruments used during enteric
disease outbreak investigations and surveillance. This includes
foodborne, waterborne, and zoonotic disease surveillance and outbreak
investigations. In addition, enhanced surveillance for antibiotic
resistant isolates is also included in this package.
Form 1. National Hypothesis Generation Questionnaire (NHGQ) defines
a core set of data elements to be used for hypothesis generation once a
given situation is determined to be a multistate foodborne or zoonotic
enteric disease investigation. NHGQ-defined elements would be used in
the early phases of an outbreak investigation to generate hypotheses
about the source(s) of infection and facilitate collaboration across
jurisdictions. This form is currently approved under OMB Control Number
0920-0997 but will be moved to this ICR upon OMB approval.
Form 2. Foodborne Focus Questionnaire--Once a leading hypothesis is
identified during the hypothesis generation phase, typically after no
more than 15 to 20 interviews using the NHGQ, a leading hypothesis is
often identified and more specific information needs to be collected,
such as type, variety, brand, and purchase location, to confirm the
hypothesis. During these later phases of an outbreak investigation, the
NHGQ is no longer used. Data collected through the Foodborne Focus
Questionnaire are utilized to tailor the next phase of the outbreak
investigation and guide potential public health action, such as a
product recall or public health alert.
Form 3. Animal Contact Focus Questionnaire--this questionnaire will
be deployed once a suspected vehicle is identified either via the
Hypothesis Generating Questionnaire or via epidemiologic data collected
in initial STLT patient interviews. DFWED would only deploy sections
relevant to the species identified as the potential outbreak vehicle.
This questionnaire would be used to confirm the hypothesized animal
vehicle, to collect information needed to take public health action
including animal contact settings, purchase locations, and pet food
brands and lot numbers, and to identify risk communication priorities
so we can instruct the public how to prevent further illnesses.
Form 4. Shigella National Hypothesis Generation Questionnaire--
Questionnaire is used for multistate outbreaks of Shigellosis.
Shigellosis is highly contagious, and as person-to-person transmission
is coming, it can be challenging to identify how individuals could have
become ill. As a result, a comprehensive hypothesis generating
questionnaire focused on a range of settings, activities, and potential
modes of transmission are needed to guide prevention and control
activities. This form is currently approved under OMB Control Number
0920-1307 but will be moved to this ICR upon OMB approval.
Form 5. NARMS SIRI Module 1 (nontyphoidal Salmonella, STEC, Vibrio,
or Campylobacter)--this questionnaire module includes questions that
will be asked of patients with nontyphoidal Salmonella, STEC, Vibrio,
or Campylobacter isolates that have concerning antimicrobial
resistance. The questions will be used to characterize exposures, risk
factors, and sources of illness for resistant enteric infections to
inform efforts to prevent additional infections and the spread of
disease.
Form 6. NARMS SIRI Questionnaire Module 2 (nontyphoidal Salmonella
except multidrug-resistant Newport, STEC, or Vibrio)--this
questionnaire module includes questions that will be asked of patients
with nontyphoidal Salmonella (except serovar Newport), STEC or Vibrio
isolates that have concerning antimicrobial resistance. The questions
will be used to characterize exposures, risk factors, and sources of
illness for resistant enteric infections to inform efforts to prevent
additional infections and the spread of disease.
Form 7. NARMS SIRI Questionnaire Module 3 (multidrug-resistant
Salmonella Newport)--this questionnaire module includes questions that
will be asked of patients with multidrug-resistant Salmonella Newport
isolates. The questions will be used to characterize exposures, risk
factors, and sources of illness for resistant enteric infections to
inform efforts to prevent additional infections and the spread of
disease.
Form 8. NARMS SIRI Questionnaire Module 4 (Campylobacter)--this
questionnaire module includes questions that will be asked of patients
with Campylobacter isolates that have concerning antimicrobial
resistance. The questions will be used to characterize exposures, risk
factors, and sources of illness for resistant enteric infections to
inform efforts to prevent additional infections and the spread of
disease.
Form 9. NARMS SIRI Questionnaire Module 5 (Typhoid or
Paratyphoid)--this questionnaire module will be asked of patients with
Salmonella Typhi or Paratyphi isolates that have concerning
antimicrobial resistance. The questions will be used to characterize
exposures, risk factors, and sources of illness for resistant enteric
infections to inform efforts to prevent additional infections and the
spread of disease.
CDC requests OMB approval for an estimated 5,850 annualized burden
hours. There is no cost to respondents other than their time to
participate.
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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Cluster and outbreak case patients..... National Hypothesis 4,000 1 45/60
Generating Questionnaire.
Cluster and outbreak case patients..... Foodborne Focus 4,000 1 20/60
Questionnaire.
Cluster and outbreak case patients..... Animal Contact Focus 450 1 30/60
Questionnaire.
[[Page 24800]]
Shigellosis case patients.............. Shigella Hypothesis 1500 1 45/60
Generating Questionnaire.
Nontyphoidal Salmonella, STEC, Vibrio, NARMS SIRI Questionnaire 305 1 15/60
or Campylobacter case patients whose Module 1.
bacterial isolates have concerning
antimicrobial resistance.
Nontyphoidal Salmonella (except Newport NARMS SIRI Questionnaire 130 1 10/60
strain), STEC, or Vibrio case patients Module 2.
whose bacterial isolates have
concerning antimicrobial resistance.
Multidrug-resistant Salmonella Newport NARMS SIRI Questionnaire 125 1 15/60
case patients. Module 3.
Campylobacter case patients whose NARMS SIRI Questionnaire 50 1 25/60
bacterial isolates have concerning Module 4.
antimicrobial resistance.
Salmonella Typhi or Paratyphi case NARMS SIRI Questionnaire 50 1 20/60
patients whose bacterial isolates have Module 5.
concerning antimicrobial resistance.
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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. 2025-10724 Filed 6-11-25; 8:45 am]
BILLING CODE 4163-18-P