[Federal Register Volume 88, Number 47 (Friday, March 10, 2023)]
[Notices]
[Pages 15033-15034]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04971]



[[Page 15033]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-23-0997; Docket No. CDC-2023-0016]


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.

-----------------------------------------------------------------------

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 continuing information 
collection, as required by the Paperwork Reduction Act of 1995. This 
notice invites comment on a proposed information collection project 
titled Standardized National Hypothesis Generating Questionnaire 
(NHGQ). This questionnaire collects exposure information from ill 
people involved in a suspected multistate foodborne outbreak, and aids 
public health investigators in identifying the potential source of 
infection.

DATES: CDC must receive written comments on or before May 9, 2023.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2023-
0016 by either of the following methods:
     Federal eRulemaking Portal: www.regulations.gov. Follow 
the instructions for submitting comments.
     Mail: Jeffery M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS H21-8, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to www.regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (www.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 Jeffery M. Zirger, of the Information 
Collection Review Office, Centers for Disease Control and Prevention, 
1600 Clifton Road NE, MS H21-8, Atlanta, Georgia 30329; Telephone: 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:
    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;
    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; and
    5. Assess information collection costs.

Proposed Project

    Standardized National Hypothesis Generating Questionnaire (SNHGQ) 
(OMB Control No. 0920-0997, Exp. 5/31/2023)--Revision--National Center 
for Emerging Zoonotic and Infectious Disease (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 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 revision to this project in order to collect 
standardized information, called the Standardized National Hypothesis-
Generating Questionnaire (SNHGQ), 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 the minimum set of 
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 shorten the time to pinpoint how and 
where contamination events occur.
    The 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 suspected multistate foodborne and enteric clusters of 
infection involving over 26,000 ill people. In these investigations, an 
outbreak vehicle has been identified in 199 cases. These outbreaks have 
led to many product recalls and countless regulatory actions that have 
removed millions of pounds of contaminated vehicles out of commerce. In 
almost all instances, the SNHGQ or

[[Page 15034]]

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.
    CDC requests OMB approval for an estimated 3,000 annualized burden 
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 to 
participate.

                                                            Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             Number of    Average burden
              Type of respondents                               Form name                    Number of     responses per   per response    Total burden
                                                                                            respondents     respondent      (in hours)      (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ill individuals identified as part of an         Standardized National Hypothesis                  4,000               1           45/60           3,000
 outbreak investigation.                          Generating Questionnaire.
                                                --------------------------------------------------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............           3,000
--------------------------------------------------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2023-04971 Filed 3-9-23; 8:45 am]
BILLING CODE 4163-18-P