81 FR 70683 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 81, Issue 198 (October 13, 2016)

[Federal Register Volume 81, Number 198 (Thursday, October 13, 2016)]
[Notices]
[Pages 70683-70684]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-24668]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-17-0997]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 
the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (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]. Written comments and/or 
suggestions regarding the items contained in this notice should be 
directed to the Attention: CDC Desk Officer, Office of Management and 
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written 
comments should be received within 30 days of this notice.

Proposed Project

    Standardized National Hypothesis Generating Questionnaire (OMB 
Control Number 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 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 multi-state 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 multi-state 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 the Standardized National Hypothesis-
Generating Questionnaire (SNHGQ), used with individuals who have become 
ill during a multi-state foodborne disease event. Since the 
questionnaire is designed to be administered by public health officials 
as part of multi-state 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.
    Many of the updates to the SNHGQ were made to better align with the 
questions from other existing questionnaires. Changes include: Exposure 
sections rearranged to improve interview flow, addition of antibiotic 
exposures and descriptive clinical questions, aligning demographic 
questions to conform with other OMB-approved questionnaires, addition 
of new exposure questions of interest, deletion of exposure questions 
that do not need to be assessed, and re-wording of existing questions 
to better align with other OMB-approved questionnaires and to improve 
question comprehension. For this revision, CDC also seeks to 
incorporate a number of public recommendations received during the 60-
day public comment period.
    The total estimated annualized burden for the Standardized National 
Hypothesis Generating Questionnaire is 3,000 hours (approximately 4,000 
individuals identified during the hypothesis-generating phase of 
outbreak investigations x 45 minutes/response). There are no costs to 
respondents other than their time.

[[Page 70684]]



                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
        Type of respondents                   Form name              Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Individuals........................  Standardized National                 4,000               1           45/60
                                      Hypothesis Generating
                                      Questionnaire (Core
                                      Elements).
----------------------------------------------------------------------------------------------------------------


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. 2016-24668 Filed 10-12-16; 8:45 am]
BILLING CODE 4163-18-P