[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.
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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]
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