[Federal Register Volume 81, Number 120 (Wednesday, June 22, 2016)]
[Notices]
[Pages 40700-40701]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14727]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-16-0997; Docket No. CDC-2016-0054]


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 efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on Using the 
Standardized National Hypothesis Generating Questionnaire during 
Multistate Investigations of Foodborne Disease Clusters and Outbreaks.

DATES: Written comments must be received on or before August 22, 2016.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0054 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, 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. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.

    Please note:  All public comment should be submitted 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 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 OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; (d) ways to 
minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information.

Proposed Project

    Standardized National Hypothesis Generating Questionnaire (0920-
0997, Expiration Date 10/31/2016)--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 1 in 6 Americans gets 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

[[Page 40701]]

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 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 implementation of the SNHGQ in 2013, 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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                                                                                                                              Average
                                                                                             Number of       Number of      burden per     Total burden
              Type of respondents                               Form name                   respondents    responses per   response (in      (in hrs)
                                                                                                            respondent         hrs)
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Individuals....................................  Standardized National Hypothesis                  4,000               1           45/60           3,000
                                                  Generating Questionnaire (Core
                                                  Elements).
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............           3,000
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Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2016-14727 Filed 6-21-16; 8:45 am]
 BILLING CODE 4163-18-P