[Federal Register Volume 84, Number 202 (Friday, October 18, 2019)]
[Notices]
[Pages 55963-55965]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-22735]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-20-0997; Docket No. CDC-2019-0087]


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.

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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 proposed and/or 
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. The information collected will be used to 
define a core set of data elements to be used for hypothesis generation 
once a given situation is determined to be a multistate foodborne 
outbreak investigation.

DATES: CDC must receive written comments on or before December 17, 
2019.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2019-
0087 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to Regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (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 Jeffrey M. Zirger, of the Information 
Collection Review Office, Centers for Disease Control and Prevention, 
1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: 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; and
    4. Minimize the burden of the collection of information on those 
who

[[Page 55964]]

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.
    5. Assess information collection costs.

Proposed Project

    Standardized National Hypothesis Generating Questionnaire (OMB 
Control No. 0920-0997, Exp. 2/29/2020)--Revision--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 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 (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 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 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 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    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
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Ill individuals identified as   Standardized               4,000               1           45/60           3,000
 part of an outbreak             National
 investigation.                  Hypothesis
                                 Generating
                                 Questionnaire.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           3,000
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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. 2019-22735 Filed 10-17-19; 8:45 am]
 BILLING CODE 4163-18-P