[Federal Register Volume 85, Number 34 (Thursday, February 20, 2020)]
[Notices]
[Pages 9778-9779]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03342]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-20-0997]


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 October 
18, 2019 to obtain comments from the public and affected agencies. CDC 
received one non-substantive public comment 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 or send an email to [email protected]. 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, Exp. 02/29/2020)--Revision--National Center for Emerging 
and Zoonotic Infectious Diseases

[[Page 9779]]

(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 U.S. 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 to collect standardized 
information, called the Standardized National Hypothesis-Generating 
Questionnaire, 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 Standardized National Hypothesis Generating Questionnaire 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 element 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 2016, ORPB has investigated 
over 700 multistate foodborne and enteric clusters of infection 
involving over 26,000 ill people. Of which, an outbreak vehicle has 
been identified in 200 of these investigations. These outbreaks have 
led to over 50 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 for the Standardized National 
Generating Questionnaire 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)
----------------------------------------------------------------------------------------------------------------
Ill individuals identified as part  Standardized National               4,000                1            3,000
 of an outbreak investigation.       Hypothesis Generating
                                     Questionnaire.
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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. 2020-03342 Filed 2-19-20; 8:45 am]
 BILLING CODE 4163-18-P