81 FR 58511 - Agency Forms Undergoing Paperwork Reduction Act Review

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

Federal Register Volume 81, Issue 165 (August 25, 2016)

Page Range		58511-58512
FR Document		2016-20333

Federal Register, Volume 81 Issue 165 (Thursday, August 25, 2016)

[Federal Register Volume 81, Number 165 (Thursday, August 25, 2016)]
[Notices]
[Pages 58511-58512]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-20333]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-16-0997]


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

[[Page 58512]]

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 No. 0920-0997, expires 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 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.
    Using the Standardized National Hypothesis-Generating Questionnaire 
(SNHGQ), CDC requests OMB approval to collect standardized information 
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 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.
    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 x 45 minutes/response). There are no costs to 
respondents other than their time.

                                        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. 2016-20333 Filed 8-24-16; 8:45 am]
 BILLING CODE 4163-18-P

58512 Federal Register / Vol. 81, No. 165 / Thursday, August 25, 2016 / Notices

proposed collection of information is Background and Brief Description ensure that similar exposures would be
necessary for the proper performance of It is estimated that each year roughly ascertained across many jurisdictions,
the functions of the agency, including 1 in 6 Americans gets sick, 128,000 are allowing for rapid pooling of data to
whether the information will have hospitalized, and 3,000 die of foodborne improve the timeliness of hypothesis-
practical utility; (b) Evaluate the diseases. CDC and partners ensure rapid generating analyses and shorten the
accuracy of the agencies estimate of the and coordinated surveillance, detection, time to pinpoint how and where
burden of the proposed collection of and response to multistate outbreaks, to contamination events occur.
information, including the validity of limit the number of illnesses, and to The SNHGQ was designed as a data
the methodology and assumptions used; learn how to prevent similar outbreaks collection tool for the core elements, to
(c) Enhance the quality, utility, and from happening in the future. be used when a multistate cluster of
clarity of the information to be Conducting interviews during the enteric disease infections is identified.
collected; (d) Minimize the burden of initial hypothesis-generating phase of The questionnaire is designed to be
the collection of information on those multistate foodborne disease outbreaks administered over the phone by public
presents numerous challenges. In the health officials to collect core elements
who are to respond, including through
U.S. there is not a standard, national data from case-patients or their proxies.
the use of appropriate automated,
form or data collection system for Both the content of the questionnaire
electronic, mechanical, or other
illnesses caused by many enteric (the core elements) and the format were
technological collection techniques or developed through a series of working
other forms of information technology, pathogens. Data elements for hypothesis
generation must be developed and groups comprised of local, state, and
e.g., permitting electronic submission of federal public health partners.
agreed upon for each investigation. This
responses; and (e) Assess information Many of the updates to the SNHGQ
process can take several days to weeks
collection costs. were made to better align with the
and may cause interviews to occur long
To request additional information on after a person becomes ill. questions from other existing
the proposed project or to obtain a copy Using the Standardized National questionnaires. Changes include:
of the information collection plan and Hypothesis-Generating Questionnaire Exposure sections rearranged to
instruments, call (404) 639–7570 or (SNHGQ), CDC requests OMB approval improve interview flow, addition of
send an email to omb@cdc.gov. Written to collect standardized information from antibiotic exposures and descriptive
comments and/or suggestions regarding individuals who have become ill during clinical questions, aligning demographic
the items contained in this notice a multistate foodborne disease event. questions to conform with other OMB-
should be directed to the Attention: Since the questionnaire is designed to approved questionnaires, addition of
CDC Desk Officer, Office of Management be administered by public health new exposure questions of interest,
and Budget, Washington, DC 20503 or officials as part of multistate hypothesis- deletion of exposure questions that do
by fax to (202) 395–5806. Written generating interview activities, this not need to be assessed, and re-wording
questionnaire is not expected to entail of existing questions to better align with
comments should be received within 30
significant burden to respondents. other OMB-approved questionnaires
days of this notice.
The Standardized National and to improve question
Proposed Project Hypothesis-Generating Core Elements comprehension.
Project was established with the goal to The total estimated annualized
Standardized National Hypothesis define a core set of data elements to be burden for the Standardized National
Generating Questionnaire (OMB Control used for hypothesis generation during Generating Questionnaire is 3,000 hours
No. 0920–0997, expires 10/31/2016)— multistate foodborne investigations. (approximately 4,000 individuals
Revision—National Center for Emerging These elements represent the minimum identified during the hypothesis-
and Zoonotic Infectious Diseases set of information that should be generating phase of outbreak
(NCEZID), Centers for Disease Control available for all outbreak-associated investigations × 45 minutes/response).
and Prevention (CDC). cases identified during hypothesis There are no costs to respondents other
generation. The core elements would than their time.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Type of Number of burden
Form name responses per
respondents respondents per response
respondent (in hours)

Individuals ............................... Standardized National Hypothesis Generating Questionnaire 4,000 1 45/60
(Core Elements).

Leroy A. Richardson,
asabaliauskas on DSK3SPTVN1PROD with NOTICES

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. 2016–20333 Filed 8–24–16; 8:45 am]
BILLING CODE 4163–18–P

VerDate Sep<11>2014 18:54 Aug 24, 2016 Jkt 238001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\25AUN1.SGM 25AUN1

Document Created: 2016-08-25 00:35:14
Document Modified: 2016-08-25 00:35:14

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
FR Citation		81 FR 58511

81 FR 58511 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

Federal Register Volume 81, Issue 165 (August 25, 2016)

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