81_FR_70881 81 FR 70683 - Agency Forms Undergoing Paperwork Reduction Act Review

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)

Page Range70683-70684
FR Document2016-24668

Federal Register, Volume 81 Issue 198 (Thursday, 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]


-----------------------------------------------------------------------

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



                                                                         Federal Register / Vol. 81, No. 198 / Thursday, October 13, 2016 / Notices                                          70683

                                             and opportunities for public private                    clarity of the information to be                      activities, this questionnaire is not
                                             partnerships. The Council is composed                   collected; (d) Minimize the burden of                 expected to entail significant burden to
                                             of members of the public, appointed by                  the collection of information on those                respondents.
                                             the Secretary, and Federal ex-officio                   who are to respond, including through                    The Standardized National
                                             members specified in the authorizing                    the use of appropriate automated,                     Hypothesis-Generating Core Elements
                                             legislation.                                            electronic, mechanical, or other                      Project was established with the goal to
                                             II. Agenda                                              technological collection techniques or                define a core set of data elements to be
                                                                                                     other forms of information technology,                used for hypothesis generation during
                                                The Council meeting will convene at                  e.g., permitting electronic submission of
                                             8:30 a.m., with the call to order by the                                                                      multistate foodborne investigations.
                                                                                                     responses; and (e) Assess information                 These elements represent the minimum
                                             Council Chair and approval of previous                  collection costs.
                                             Council summary notes. The meeting is                                                                         set of information that should be
                                                                                                       To request additional information on
                                             open to the public and will be available                                                                      available for all outbreak-associated
                                                                                                     the proposed project or to obtain a copy
                                             via webcast at                                                                                                cases identified during hypothesis
                                                                                                     of the information collection plan and
                                             www.webconferences.com/ahrq. The                                                                              generation. The core elements would
                                                                                                     instruments, call (404) 639–7570 or
                                             meeting will begin with an update on                                                                          ensure that similar exposures would be
                                                                                                     send an email to omb@cdc.gov. Written
                                             AHRQ’s current research, programs, and                                                                        ascertained across many jurisdictions,
                                                                                                     comments and/or suggestions regarding
                                             initiatives.                                                                                                  allowing for rapid pooling of data to
                                                                                                     the items contained in this notice
                                                Following this update, the agenda                                                                          improve the timeliness of hypothesis-
                                                                                                     should be directed to the Attention:
                                             will focus on a discussion of the                                                                             generating analyses and shorten the
                                                                                                     CDC Desk Officer, Office of Management
                                             learning health care system. The final                                                                        time to pinpoint how and where
                                                                                                     and Budget, Washington, DC 20503 or
                                             agenda will be available on the AHRQ                                                                          contamination events occur.
                                                                                                     by fax to (202) 395–5806. Written
                                             Web site at www.AHRQ.gov no later                       comments should be received within 30                    The SNHGQ was designed as a data
                                             than Wednesday, October 26, 2016.                       days of this notice.                                  collection tool for the core elements, to
                                             Sharon B. Arnold,                                                                                             be used when a multistate cluster of
                                                                                                     Proposed Project                                      enteric disease infections is identified.
                                             Deputy Director.
                                                                                                       Standardized National Hypothesis                    The questionnaire is designed to be
                                             [FR Doc. 2016–24742 Filed 10–12–16; 8:45 am]
                                                                                                     Generating Questionnaire (OMB Control                 administered over the phone by public
                                             BILLING CODE 4160–90–P
                                                                                                     Number 0920–0997, Expiration Date 10/                 health officials to collect core elements
                                                                                                     31/2016)—Revision—National Center                     data from case-patients or their proxies.
                                             DEPARTMENT OF HEALTH AND                                for Emerging and Zoonotic Infectious                  Both the content of the questionnaire
                                             HUMAN SERVICES                                          Diseases (NCEZID), Centers for Disease                (the core elements) and the format were
                                                                                                     Control and Prevention (CDC).                         developed through a series of working
                                             Centers for Disease Control and                                                                               groups comprised of local, state, and
                                                                                                     Background and Brief Description
                                             Prevention                                                                                                    federal public health partners.
                                                                                                        It is estimated that each year roughly
                                             [30Day–17–0997]                                                                                                  Many of the updates to the SNHGQ
                                                                                                     1 in 6 Americans get sick, 128,000 are
                                                                                                                                                           were made to better align with the
                                                                                                     hospitalized, and 3,000 die of foodborne
                                             Agency Forms Undergoing Paperwork                                                                             questions from other existing
                                                                                                     diseases. CDC and partners ensure rapid
                                             Reduction Act Review                                                                                          questionnaires. Changes include:
                                                                                                     and coordinated surveillance, detection,
                                                                                                                                                           Exposure sections rearranged to
                                                The Centers for Disease Control and                  and response to multi-state outbreaks, to
                                                                                                                                                           improve interview flow, addition of
                                             Prevention (CDC) has submitted the                      limit the number of illnesses, and to
                                                                                                                                                           antibiotic exposures and descriptive
                                             following information collection request                learn how to prevent similar outbreaks
                                                                                                                                                           clinical questions, aligning demographic
                                             to the Office of Management and Budget                  from happening in the future.
                                                                                                        Conducting interviews during the                   questions to conform with other OMB-
                                             (OMB) for review and approval in
                                                                                                     initial hypothesis-generating phase of                approved questionnaires, addition of
                                             accordance with the Paperwork
                                                                                                     multi-state foodborne disease outbreaks               new exposure questions of interest,
                                             Reduction Act of 1995. The notice for
                                                                                                     presents numerous challenges. In the                  deletion of exposure questions that do
                                             the proposed information collection is
                                                                                                     U.S. there is not a standard, national                not need to be assessed, and re-wording
                                             published to obtain comments from the
                                             public and affected agencies.                           form or data collection system for                    of existing questions to better align with
                                                Written comments and suggestions                     illnesses caused by many enteric                      other OMB-approved questionnaires
                                             from the public and affected agencies                   pathogens. Data elements for hypothesis               and to improve question
                                             concerning the proposed collection of                   generation must be developed and                      comprehension. For this revision, CDC
                                             information are encouraged. Your                        agreed upon for each investigation. This              also seeks to incorporate a number of
                                             comments should address any of the                      process can take several days to weeks                public recommendations received
                                             following: (a) Evaluate whether the                     and may cause interviews to occur long                during the 60-day public comment
                                             proposed collection of information is                   after a person becomes ill.                           period.
                                             necessary for the proper performance of                    CDC requests a revision to the                        The total estimated annualized
                                             the functions of the agency, including                  Standardized National Hypothesis-                     burden for the Standardized National
                                             whether the information will have                       Generating Questionnaire (SNHGQ),                     Hypothesis Generating Questionnaire is
                                             practical utility; (b) Evaluate the                     used with individuals who have become                 3,000 hours (approximately 4,000
                                             accuracy of the agencies estimate of the                ill during a multi-state foodborne                    individuals identified during the
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                                             burden of the proposed collection of                    disease event. Since the questionnaire is             hypothesis-generating phase of outbreak
                                             information, including the validity of                  designed to be administered by public                 investigations × 45 minutes/response).
                                             the methodology and assumptions used;                   health officials as part of multi-state               There are no costs to respondents other
                                             (c) Enhance the quality, utility, and                   hypothesis-generating interview                       than their time.




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                                             70684                             Federal Register / Vol. 81, No. 198 / Thursday, October 13, 2016 / Notices

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

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



                                             Leroy A. Richardson,                                            ADDRESSES:   You may submit comments,                 whether the information shall have
                                             Chief, Information Collection Review Office,                    identified by Docket No. CDC–2016–                    practical utility; (b) the accuracy of the
                                             Office of Scientific Integrity, Office of the                   0097 by any of the following methods:                 agency’s estimate of the burden of the
                                             Associate Director for Science, Office of the                     • Federal eRulemaking Portal:                       proposed collection of information; (c)
                                             Director, Centers for Disease Control and                       Regulations.gov. Follow the instructions              ways to enhance the quality, utility, and
                                             Prevention.                                                     for submitting comments.                              clarity of the information to be
                                             [FR Doc. 2016–24668 Filed 10–12–16; 8:45 am]                      • Mail: Leroy A. Richardson,                        collected; (d) ways to minimize the
                                             BILLING CODE 4163–18–P                                          Information Collection Review Office,                 burden of the collection of information
                                                                                                             Centers for Disease Control and                       on respondents, including through the
                                                                                                             Prevention, 1600 Clifton Road NE., MS–                use of automated collection techniques
                                             DEPARTMENT OF HEALTH AND                                        D74, Atlanta, Georgia 30329.                          or other forms of information
                                             HUMAN SERVICES                                                    Instructions: All submissions received              technology; and (e) estimates of capital
                                                                                                             must include the agency name and                      or start-up costs and costs of operation,
                                             Centers for Disease Control and                                 Docket Number. All relevant comments
                                             Prevention                                                                                                            maintenance, and purchase of services
                                                                                                             received will be posted without change                to provide information. Burden means
                                                                                                             to Regulations.gov, including any                     the total time, effort, or financial
                                             [60Day–17–16BGH; Docket No. CDC–2016–                           personal information provided. For                    resources expended by persons to
                                             0097]                                                           access to the docket to read background               generate, maintain, retain, disclose or
                                                                                                             documents or comments received, go to                 provide information to or for a Federal
                                             Proposed Data Collection Submitted                              Regulations.gov.
                                             for Public Comment and                                                                                                agency. This includes the time needed
                                                                                                               Please note: All public comment should be           to review instructions; to develop,
                                             Recommendations                                                 submitted through the Federal eRulemaking             acquire, install and utilize technology
                                                                                                             portal (Regulations.gov) or by U.S. mail to the       and systems for the purpose of
                                             AGENCY: Centers for Disease Control and                         address listed above.
                                             Prevention (CDC), Department of Health                                                                                collecting, validating and verifying
                                             and Human Services (HHS).                                       FOR FURTHER INFORMATION CONTACT:     To               information, processing and
                                                                                                             request more information on the                       maintaining information, and disclosing
                                             ACTION:     Notice with comment period.                         proposed project or to obtain a copy of               and providing information; to train
                                                                                                             the information collection plan and                   personnel and to be able to respond to
                                             SUMMARY:   The Centers for Disease
                                                                                                             instruments, contact the Information                  a collection of information, to search
                                             Control and Prevention (CDC), as part of
                                                                                                             Collection Review Office, Centers for                 data sources, to complete and review
                                             its continuing efforts to reduce public
                                                                                                             Disease Control and Prevention, 1600                  the collection of information; and to
                                             burden and maximize the utility of
                                                                                                             Clifton Road NE., MS–D74, Atlanta,                    transmit or otherwise disclose the
                                             government information, invites the
                                                                                                             Georgia 30329; phone: 404–639–7570;                   information.
                                             general public and other Federal
                                                                                                             Email: omb@cdc.gov.
                                             agencies to take this opportunity to                                                                                  Proposed Project
                                                                                                             SUPPLEMENTARY INFORMATION: Under the
                                             comment on proposed and/or                                                                                              ‘‘Data Collection for Canine
                                             continuing information collections, as                          Paperwork Reduction Act of 1995 (PRA)
                                                                                                             (44 U.S.C. 3501–3520), Federal agencies               Leptospirosis Surveillance in Puerto
                                             required by the Paperwork Reduction                                                                                   Rico’’—Existing Collection in Use
                                             Act of 1995. This notice invites                                must obtain approval from the Office of
                                                                                                             Management and Budget (OMB) for each                  without an OMB Control Number—
                                             comment on data collection project                                                                                    National Center for Emerging and
                                                                                                             collection of information they conduct
                                             entitled ‘‘Data Collection for Canine                                                                                 Zoonotic Diseases (NCEZID), Centers for
                                                                                                             or sponsor. In addition, the PRA also
                                             Leptospirosis Surveillance in Puerto                                                                                  Disease Control and Prevention (CDC).
                                                                                                             requires Federal agencies to provide a
                                             Rico.’’ The goals of the project are to
                                                                                                             60-day notice in the Federal Register                 Background and Brief Description
                                             characterize the epidemiology of canine
                                                                                                             concerning each proposed collection of
                                             leptospirosis, assess the applicability of                                                                              The Centers for Disease Control and
                                                                                                             information, including each new
                                             canine Leptospira vaccines used in                                                                                    Prevention (CDC) Bacterial Special
                                                                                                             proposed collection, each proposed
                                             Puerto Rico, and determine potential                                                                                  Pathogens Branch (BSPB) requests
                                                                                                             extension of existing collection of
                                             rodent, livestock, and wildlife reservoirs                                                                            approval of data collection tools to be
                                                                                                             information, and each reinstatement of
                                             for leptospirosis. Findings from the                                                                                  used for active surveillance of canine
                                                                                                             previously approved information
                                             study will be used to develop                                                                                         leptospirosis in Puerto Rico. Active
                                                                                                             collection before submitting the
                                             recommendations for the prevention of                                                                                 surveillance will allow for the collection
                                                                                                             collection to OMB for approval. To
                                             leptospirosis in dogs, focus human
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                                                                                                             comply with this requirement, we are                  of prospective data on acute cases to
                                             surveillance efforts, and guide further                                                                               determine the incidence and
                                                                                                             publishing this notice of a proposed
                                             investigations on leptospirosis in Puerto                                                                             distribution of leptospirosis in dogs,
                                                                                                             data collection as described below.
                                             Rico.                                                              Comments are invited on: (a) Whether               assess risk factors for infection,
                                             DATES: Written comments must be                                 the proposed collection of information                characterize circulating Leptospira
                                             received on or before December 12,                              is necessary for the proper performance               serovars and species, assess
                                             2016.                                                           of the functions of the agency, including             applicability of vaccines currently in


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Document Created: 2016-10-13 00:53:46
Document Modified: 2016-10-13 00:53:46
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
FR Citation81 FR 70683 

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