82_FR_16907 82 FR 16842 - Agency Forms Undergoing Paperwork Reduction Act Review

82 FR 16842 - Agency Forms Undergoing Paperwork Reduction Act Review

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

Federal Register Volume 82, Issue 65 (April 6, 2017)

Page Range16842-16843
FR Document2017-06869

Federal Register, Volume 82 Issue 65 (Thursday, April 6, 2017)
[Federal Register Volume 82, Number 65 (Thursday, April 6, 2017)]
[Notices]
[Pages 16842-16843]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-06869]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30 Day-17-17IM]


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

    Use of the Cyclosporiasis National Hypothesis Generating 
Questionnaire (CNHGQ) during Investigations of Foodborne Disease 
Clusters and Outbreaks--New--Center for Global Health (CGH), Centers 
for Disease Control and Prevention (CDC).

Background and Brief Description

    An estimated 1 in six Americans per year become ill with a 
foodborne disease. Foodborne outbreaks of cyclosporiasis--caused by the 
parasite Cyclospora cayetanensis--have been reported in the United 
States since the mid-1990s and have been linked to various types of 
fresh produce. During the 15-year period of 2000-2014, 31 U.S. 
foodborne outbreaks of cyclosporiasis were reported; the total case 
count was 1,562. It is likely that more cases (and outbreaks) occurred 
than were reported; in addition, because of insufficient data, many of 
the reported cases could not be directly linked to an outbreak or to a 
particular food vehicle.
    Collecting the requisite data for the initial hypothesis-generating 
phase of investigations of multistate foodborne disease outbreaks is 
associated with multiple challenges, including the need to have high-
quality hypothesis-generating questionnaire(s) that can be used 
effectively in multijurisdictional investigations. Such a questionnaire 
was developed in the past for use in the context of foodborne outbreaks 
caused by bacterial pathogens; that

[[Page 16843]]

questionnaire is referred to as the Standardized National Hypothesis 
Generating Questionnaire (SNHGQ). However, not all of the data elements 
in the SNHGQ are relevant to the parasite Cyclospora (e.g., questions 
about consumption of meat and dairy products); on the other hand, 
additional data elements (besides those in the SNHGQ) are needed to 
capture information pertinent to Cyclospora and to fresh produce 
vehicles of infection. Therefore, the Cyclosporiasis National 
Hypothesis Generating Questionnaire (CNHGQ) has been developed, by 
using core data elements from the SNHGQ and incorporating modifications 
pertinent to Cyclospora.
    The core data elements from the SNHGQ were developed by a series of 
working groups comprised of local, state, and federal public health 
partners. Subject matter experts at CDC have developed the CNHGQ, by 
modifying the SNHGQ to include and focus on data elements pertinent to 
Cyclospora/cyclosporiasis. Input also was solicited from state public 
health partners. Because relatively few data elements in the SNHGQ 
needed to be modified, a full vetting process was determined not to be 
necessary. The CNHGQ has been designed for administration over the 
telephone by public health officials, to collect data elements from 
case-patients or their proxies. The data that is collected will be 
pooled and analyzed at CDC, to generate hypotheses about potential 
vehicles/sources of infection.
    CDC requests OMB approval to collect information via the CNHGQ from 
persons who have developed symptomatic cases of Cyclospora infection 
during periods in which increased numbers of such cases are reported 
(typically, during spring and summer months). In part because molecular 
typing methods are not yet available for C. cayetanensis, it is 
important to interview all case-patients identified during periods of 
increased reporting, to help determine if their cases could be part of 
an outbreak(s).
    The CNHGQ is not expected to entail substantial burden for 
respondents. The estimated total annualized burden associated with 
administering the CNHGQ is 750 hours (approximately 1,000 individuals 
interviewed x 45 minutes/response). There will be 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        (hours)
----------------------------------------------------------------------------------------------------------------
Individuals.......................  Cyclosporiasis National                1,000               1           45/60
                                     Hypothesis Generating
                                     Questionnaire.
----------------------------------------------------------------------------------------------------------------


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. 2017-06869 Filed 4-5-17; 8:45 am]
 BILLING CODE 4163-18-P



                                                  16842                                   Federal Register / Vol. 82, No. 65 / Thursday, April 6, 2017 / Notices

                                                  scales through an online data portal                                    surveillance, and target allocation of                                        primary recipients and instructed to set
                                                  called MosquitoNET (https://                                            surveillance and prevention resources.                                        up accounts on the MosquitoNET Web
                                                  wwwn.cdc.gov/Arbonet/MosquitoNET)                                       As part of the Zika response, efforts to                                      site via a simple process. Data collection
                                                  and will be expanded to include                                         identify Ae. aegypti and Ae. albopictus                                       from ELC recipients will then begin. In
                                                  insecticide susceptibility and resistance                               in the continental U.S. were                                                  order to limit the burden of data entry
                                                  data on local populations of mosquitos.                                 substantially enhanced during 2016 and                                        on respondents who may be entering
                                                  Data will be collected monthly through                                  funding will be provided to states to                                         information for their state, they will
                                                  the expiration date of this OMB                                         continue to enhance surveillance for                                          have the option of submitting the data
                                                  approval.                                                               these vectors through the longstanding                                        via email to CDC using an excel survey.
                                                     Such information will aid in (1)                                     Epidemiology and Laboratory Capacity
                                                  targeting vector control efforts to                                     Program that was expanded to now                                                 This information collection request is
                                                  prevent mosquito-borne Zika virus                                       include mosquito surveillance.                                                authorized by Section 301 of the Public
                                                  transmission in the continental U.S. and                                  Respondents will include vector                                             Health Service Act (42 U.S.C. 241). The
                                                  (2) targeting future vector surveillance                                control professionals, entomologists,                                         total estimated annualized burden time
                                                  efforts. The resulting maps and models                                  and public health professionals who are                                       is 192 hours. There will be no
                                                  will inform the public and policy                                       recipients of ELC funding or their                                            anticipated costs to respondents other
                                                  makers of the known distribution of                                     designated points of contact. The                                             than time.
                                                  these vectors, identify gaps in vector                                  respondents will be contacted via ELC

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

                                                  Vector control professionals, ento-                      MosquitoNET entry of monthly sur-                                                64                          12                    15/60                192
                                                    mologists, and Public health pro-                       veillance   records  of    Aedes
                                                    fessionals.                                             aegypti and Aedes albopictus.

                                                       Total ...........................................   ...........................................................   ........................   ........................   ........................            192



                                                  Leroy A. Richardson,                                                    necessary for the proper performance of                                       (CNHGQ) during Investigations of
                                                  Chief, Information Collection Review Office,                            the functions of the agency, including                                        Foodborne Disease Clusters and
                                                  Office of Scientific Integrity, Office of the                           whether the information will have                                             Outbreaks—New—Center for Global
                                                  Associate Director for Science, Office of the                           practical utility; (b) Evaluate the                                           Health (CGH), Centers for Disease
                                                  Director, Centers for Disease Control and                               accuracy of the agencies estimate of the                                      Control and Prevention (CDC).
                                                  Prevention.                                                             burden of the proposed collection of
                                                  [FR Doc. 2017–06865 Filed 4–5–17; 8:45 am]                                                                                                            Background and Brief Description
                                                                                                                          information, including the validity of
                                                  BILLING CODE 4163–18–P                                                  the methodology and assumptions used;                                            An estimated 1 in six Americans per
                                                                                                                          (c) Enhance the quality, utility, and                                         year become ill with a foodborne
                                                                                                                          clarity of the information to be                                              disease. Foodborne outbreaks of
                                                  DEPARTMENT OF HEALTH AND                                                collected; (d) Minimize the burden of                                         cyclosporiasis—caused by the parasite
                                                  HUMAN SERVICES                                                          the collection of information on those                                        Cyclospora cayetanensis—have been
                                                                                                                          who are to respond, including through                                         reported in the United States since the
                                                  Centers for Disease Control and                                                                                                                       mid-1990s and have been linked to
                                                  Prevention                                                              the use of appropriate automated,
                                                                                                                          electronic, mechanical, or other                                              various types of fresh produce. During
                                                                                                                          technological collection techniques or                                        the 15-year period of 2000–2014, 31
                                                  [30 Day–17–17IM]
                                                                                                                          other forms of information technology,                                        U.S. foodborne outbreaks of
                                                  Agency Forms Undergoing Paperwork                                       e.g., permitting electronic submission of                                     cyclosporiasis were reported; the total
                                                  Reduction Act Review                                                    responses; and (e) Assess information                                         case count was 1,562. It is likely that
                                                                                                                          collection costs.                                                             more cases (and outbreaks) occurred
                                                     The Centers for Disease Control and                                     To request additional information on                                       than were reported; in addition, because
                                                  Prevention (CDC) has submitted the                                      the proposed project or to obtain a copy                                      of insufficient data, many of the
                                                  following information collection request                                of the information collection plan and                                        reported cases could not be directly
                                                  to the Office of Management and Budget                                  instruments, call (404) 639–7570 or                                           linked to an outbreak or to a particular
                                                  (OMB) for review and approval in                                        send an email to omb@cdc.gov. Written                                         food vehicle.
                                                  accordance with the Paperwork                                           comments and/or suggestions regarding                                            Collecting the requisite data for the
                                                  Reduction Act of 1995. The notice for                                   the items contained in this notice                                            initial hypothesis-generating phase of
                                                  the proposed information collection is                                  should be directed to the Attention:                                          investigations of multistate foodborne
                                                  published to obtain comments from the                                   CDC Desk Officer, Office of Management                                        disease outbreaks is associated with
                                                  public and affected agencies.                                                                                                                         multiple challenges, including the need
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                                                                                                                          and Budget, Washington, DC 20503 or
                                                     Written comments and suggestions                                     by fax to (202) 395–5806. Written                                             to have high-quality hypothesis-
                                                  from the public and affected agencies                                   comments should be received within 30                                         generating questionnaire(s) that can be
                                                  concerning the proposed collection of                                   days of this notice.                                                          used effectively in multijurisdictional
                                                  information are encouraged. Your                                                                                                                      investigations. Such a questionnaire was
                                                  comments should address any of the                                      Proposed Project                                                              developed in the past for use in the
                                                  following: (a) Evaluate whether the                                       Use of the Cyclosporiasis National                                          context of foodborne outbreaks caused
                                                  proposed collection of information is                                   Hypothesis Generating Questionnaire                                           by bacterial pathogens; that


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                                                                                      Federal Register / Vol. 82, No. 65 / Thursday, April 6, 2017 / Notices                                             16843

                                                  questionnaire is referred to as the                        state, and federal public health partners.            symptomatic cases of Cyclospora
                                                  Standardized National Hypothesis                           Subject matter experts at CDC have                    infection during periods in which
                                                  Generating Questionnaire (SNHGQ).                          developed the CNHGQ, by modifying                     increased numbers of such cases are
                                                  However, not all of the data elements in                   the SNHGQ to include and focus on                     reported (typically, during spring and
                                                  the SNHGQ are relevant to the parasite                     data elements pertinent to Cyclospora/                summer months). In part because
                                                  Cyclospora (e.g., questions about                          cyclosporiasis. Input also was solicited              molecular typing methods are not yet
                                                  consumption of meat and dairy                              from state public health partners.                    available for C. cayetanensis, it is
                                                  products); on the other hand, additional                   Because relatively few data elements in               important to interview all case-patients
                                                  data elements (besides those in the                        the SNHGQ needed to be modified, a                    identified during periods of increased
                                                  SNHGQ) are needed to capture                               full vetting process was determined not               reporting, to help determine if their
                                                  information pertinent to Cyclospora and                    to be necessary. The CNHGQ has been                   cases could be part of an outbreak(s).
                                                  to fresh produce vehicles of infection.                    designed for administration over the
                                                  Therefore, the Cyclosporiasis National                     telephone by public health officials, to                The CNHGQ is not expected to entail
                                                  Hypothesis Generating Questionnaire                        collect data elements from case-patients              substantial burden for respondents. The
                                                  (CNHGQ) has been developed, by using                       or their proxies. The data that is                    estimated total annualized burden
                                                  core data elements from the SNHGQ and                      collected will be pooled and analyzed at              associated with administering the
                                                  incorporating modifications pertinent to                   CDC, to generate hypotheses about                     CNHGQ is 750 hours (approximately
                                                  Cyclospora.                                                potential vehicles/sources of infection.              1,000 individuals interviewed x 45
                                                    The core data elements from the                             CDC requests OMB approval to collect               minutes/response). There will be no
                                                  SNHGQ were developed by a series of                        information via the CNHGQ from                        costs to respondents other than their
                                                  working groups comprised of local,                         persons who have developed                            time.

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

                                                  Individuals .....................   Cyclosporiasis National Hypothesis Generating Questionnaire ......                    1,000                1         45/60



                                                  Leroy A. Richardson,                                       60 days for public comment on the                     Control Number ____, Room C4–26–05,
                                                  Chief, Information Collection Review Office,               proposed action. Interested persons are               7500 Security Boulevard, Baltimore,
                                                  Office of Scientific Integrity, Office of the              invited to send comments regarding our                Maryland 21244–1850.
                                                  Associate Director for Science, Office of the              burden estimates or any other aspect of                 To obtain copies of a supporting
                                                  Director, Centers for Disease Control and                  this collection of information, including             statement and any related forms for the
                                                  Prevention.                                                the necessity and utility of the proposed             proposed collection(s) summarized in
                                                  [FR Doc. 2017–06869 Filed 4–5–17; 8:45 am]                 information collection for the proper                 this notice, you may make your request
                                                  BILLING CODE 4163–18–P                                     performance of the agency’s functions,                using one of following:
                                                                                                             the accuracy of the estimated burden,                   1. Access CMS’ Web site address at
                                                                                                             ways to enhance the quality, utility, and             https://www.cms.gov/Regulations-and-
                                                  DEPARTMENT OF HEALTH AND                                   clarity of the information to be                      Guidance/Legislation/Paperwork
                                                  HUMAN SERVICES                                             collected, and the use of automated                   ReductionActof1995/PRA-Listing.html.
                                                  Centers for Medicare & Medicaid                            collection techniques or other forms of                 2. Email your request, including your
                                                  Services                                                   information technology to minimize the                address, phone number, OMB number,
                                                                                                             information collection burden.                        and CMS document identifier, to
                                                  [Document Identifiers: CMS–10147, CMS–                     DATES: Comments must be received by                   Paperwork@cms.hhs.gov.
                                                  10203, CMS–R–21, and CMS–R–148]                            June 5, 2017.                                           3. Call the Reports Clearance Office at
                                                                                                             ADDRESSES: When commenting, please                    (410) 786–1326.
                                                  Agency Information Collection
                                                                                                             reference the document identifier or                  FOR FURTHER INFORMATION CONTACT:
                                                  Activities: Proposed Collection;
                                                                                                             OMB control number. To be assured                     William Parham at (410) 786–4669.
                                                  Comment Request
                                                                                                             consideration, comments and
                                                                                                                                                                   SUPPLEMENTARY INFORMATION:
                                                  AGENCY: Centers for Medicare &                             recommendations must be submitted in
                                                  Medicaid Services, HHS.                                    any one of the following ways:                        Contents
                                                  ACTION: Notice.                                              1. Electronically. You may send your
                                                                                                             comments electronically to http://                      This notice sets out a summary of the
                                                  SUMMARY:   The Centers for Medicare &                      www.regulations.gov. Follow the                       use and burden associated with the
                                                  Medicaid Services (CMS) is announcing                      instructions for ‘‘Comment or                         following information collections. More
                                                  an opportunity for the public to                           Submission’’ or ‘‘More Search Options’’               detailed information can be found in
                                                  comment on CMS’ intention to collect                       to find the information collection                    each collection’s supporting statement
                                                  information from the public. Under the                     document(s) that are accepting                        and associated materials (see
mstockstill on DSK3G9T082PROD with NOTICES




                                                                                                                                                                   ADDRESSES).
                                                  Paperwork Reduction Act of 1995 (the                       comments.
                                                  PRA), federal agencies are required to                       2. By regular mail. You may mail                    CMS–10147 Medicare Prescription
                                                  publish notice in the Federal Register                     written comments to the following                       Drug Coverage and Your Rights
                                                  concerning each proposed collection of                     address: CMS, Office of Strategic                     CMS–10203 Medicare Health
                                                  information (including each proposed                       Operations and Regulatory Affairs,                      Outcomes Survey (HOS)
                                                  extension or reinstatement of an existing                  Division of Regulations Development,                  CMS–R–21 Withholding Medicare
                                                  collection of information) and to allow                    Attention: Document Identifier/OMB                      Payments to Recover Medicaid


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Document Created: 2017-04-06 01:46:50
Document Modified: 2017-04-06 01:46:50
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 Citation82 FR 16842 

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