80_FR_51437 80 FR 51274 - Agency Forms Undergoing Paperwork Reduction Act Review

80 FR 51274 - Agency Forms Undergoing Paperwork Reduction Act Review

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

Federal Register Volume 80, Issue 163 (August 24, 2015)

Page Range51274-51275
FR Document2015-20811

Federal Register, Volume 80 Issue 163 (Monday, August 24, 2015)
[Federal Register Volume 80, Number 163 (Monday, August 24, 2015)]
[Notices]
[Pages 51274-51275]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-20811]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-15-15AMG]


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;

[[Page 51275]]

(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

    FoodNet Population Survey--Existing Collection In Use Without an 
OMB Control Number--National Center for Emerging and Zoonotic 
Infectious Diseases, Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    Foodborne illnesses represent a significant public health burden in 
the United States. It is estimated that each year, 48 million Americans 
(1 in 6) become ill, 128,000 are hospitalized, and 3,000 die as the 
result of a foodborne illness. Since 1996, the Foodborne Diseases 
Active Surveillance Network (FoodNet) has conducted active population-
based surveillance for Campylobacter, Cryptosporidium, Cyclospora, 
Listeria, Salmonella, Shiga toxin-producing Escherichia coli O157 and 
non-O157, Shigella, Vibrio, and Yersinia infections. Data from FoodNet 
serve as the nation's ``report card'' on food safety by monitoring 
progress toward CDC Healthy People 2020 objectives.
    Evaluation of efforts to control foodborne illnesses can only be 
done effectively if there is an accurate estimate of the total number 
of illness that occur and if these estimates are recalculated and 
monitored over time. Total burden estimates of begin with an accurate 
and reliable estimate of the number of acute gastrointestinal illness 
episodes that occur in the general community. To more precisely 
estimate this and to describe the frequency of important exposures 
associated with illness, FoodNet created the Population Survey.
    The FoodNet Population Survey is a survey of persons residing in 
the surveillance area. Data are collected on the prevalence and 
severity of acute gastrointestinal illness in the general population, 
describe common symptoms associated with diarrhea, and determine the 
proportion of persons with diarrhea who seek medical care. The survey 
also collects data on exposures (e.g. food, water, animal contact) 
commonly associated with foodborne illness. Information about food 
exposures in the general public has proved invaluable during outbreak 
investigations. The ability to compare exposures reported by outbreak 
cases to the `background' exposure in the general population allows 
investigators to more quickly pinpoint a source and enact control 
measures. To date, five 12-month cycles of the survey have been 
completed without an existing OMB number: 1996-1997, 1998-1999, 2000-
2001, 2002-2003, and 2006-2007. Data has been shared with participating 
state health departments and multiple programs at CDC, is available to 
the public through a summary report posted to the FoodNet Web site, and 
also available via individual data requests. More than two dozen 
manuscripts highlighting population survey data have been published. We 
seek to continue this important work.
    The total annual burden is 6,000 hours.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                   Number of     Average  burden
         Type of respondents                 Form name            Number of      responses per    per  response
                                                                 respondents       respondent       (in hours)
----------------------------------------------------------------------------------------------------------------
U.S. General Population.............  Population Survey......          18,000                1            20/60
----------------------------------------------------------------------------------------------------------------


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. 2015-20811 Filed 8-21-15; 8:45 am]
BILLING CODE 4163-18-P



                                              51274                                Federal Register / Vol. 80, No. 163 / Monday, August 24, 2015 / Notices

                                              practical utility; (b) the accuracy of the                              Guinea—New—Center for Global Health                                           until two consecutive negative RT–PCR
                                              agency’s estimate of the burden of the                                  (CGH), Centers for Disease Control and                                        results are obtained.
                                              proposed collection of information; (c)                                 Prevention (CDC).                                                                Participants will be asked follow-up
                                              ways to enhance the quality, utility, and                                                                                                             questions until their semen specimens
                                                                                                                      Background and Brief Description
                                              clarity of the information to be                                                                                                                      test negative twice consecutively. They
                                              collected; (d) ways to minimize the                                        Much progress has been made in the                                         will receive tokens of appreciation for
                                              burden of the collection of information                                 year since the CDC first responded to                                         their participation at the initial visit and
                                              on respondents, including through the                                   the Ebola outbreak in West Africa, but                                        again at every subsequent follow-up
                                              use of automated collection techniques                                  the agency’s efforts must continue until                                      visit and a supply of condoms.
                                              or other forms of information                                           there are zero new cases of Ebola virus                                          A trained study data manager will
                                              technology; and (e) estimates of capital                                disease (EVD). In order to reach the                                          collect test results for all participants in
                                              or start-up costs and costs of operation,                               international goal of zero new EVD                                            a laboratory results form. Results and
                                              maintenance, and purchase of services                                   cases in 2015, the agency must intensify                                      analyses are needed to update relevant
                                              to provide information. Burden means                                    its efforts to identify and prevent every                                     counseling messages and
                                              the total time, effort, or financial                                    potential route of human disease                                              recommendations from the Guinea
                                              resources expended by persons to                                        transmission and to understand the                                            Ministry of Health, World Health
                                              generate, maintain, retain, disclose or                                 most current community barriers to                                            Organization, and CDC.
                                              provide information to or for a Federal                                 reaching that final goal.                                                        This program will provide the
                                              agency. This includes the time needed                                      ‘‘Screening and Counseling of Male                                         information that is critical to the
                                              to review instructions; to develop,                                     EVD Survivors to reduce Risk of                                               development of public health measures,
                                              acquire, install and utilize technology                                 Sexually Transmitting Ebola Virus in                                          such as recommendations about sexual
                                              and systems for the purpose of                                          Guinea’’ will inform male Ebola                                               activity and approaches to evaluation of
                                              collecting, validating and verifying                                    infection survivors ≥15 years of age of                                       survivors to determine whether they can
                                              information, processing and                                             Ebola virus detected in their semen                                           safely resume sexual activity. These
                                              maintaining information, and disclosing                                 through voluntary laboratory testing                                          approaches in turn are expected to
                                              and providing information; to train                                     performed in Guinea. Participants for                                         reduce the risk of Ebola resurgence and
                                              personnel and to be able to respond to                                  the semen testing program will be                                             mitigate stigma for thousands of
                                              a collection of information, to search                                  recruited by trained study staff from                                         survivors. The information is likewise
                                              data sources, to complete and review                                    Ebola treatment units (ETUs) and                                              critical to reducing the risk that Ebola
                                              the collection of information; and to                                   survivor registries in Guinea.                                                would be introduced in a location that
                                              transmit or otherwise disclose the                                      Participants will be followed up at                                           has not previously been affected.
                                              information.                                                            study sites in government hospitals.                                             CGH requests a three-year approval
                                                                                                                         Specimens will be tested for Ebola                                         for this information collection. Each
                                              Proposed Projects
                                                                                                                      Virus ribonucleic acid (RNA) by reverse                                       semen-testing program time burden is
                                                Screening and Counseling of Male                                      transcription polymerase chain reaction                                       2,067 hours which is incurred by 1,000
                                              EVD Survivors to reduce Risk of                                         test (RT–PCR). Semen specimens will be                                        participants. There are no other costs to
                                              Sexually Transmitting Ebola Virus in                                    collected and tested every two weeks                                          the respondents other than their time.

                                                                                                                     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.)

                                              Male Ebola Survivors ≥15 years old                       Baseline Questionnaire ....................                                 1,000                              1                  20/60                 334
                                              Male Ebola Survivors ≥15 years old                       Follow-up Questionnaire ..................                                  1,000                              8                  10/60               1,334
                                              Male Ebola Survivors ≥15 years old                       Consent Form ..................................                             1,000                              1                   2/60                  34

                                                   Total ...........................................   ...........................................................   ........................   ........................   ........................          1,702



                                              Leroy A. Richardson,                                                    DEPARTMENT OF HEALTH AND                                                      published to obtain comments from the
                                              Chief, Information Collection Review Office,                            HUMAN SERVICES                                                                public and affected agencies.
                                              Office of Scientific Integrity, Office of the                                                                                                            Written comments and suggestions
                                              Associate Director for Science, Office of the                           Centers for Disease Control and
                                                                                                                                                                                                    from the public and affected agencies
                                              Director, Centers for Disease Control and                               Prevention
                                                                                                                                                                                                    concerning the proposed collection of
                                              Prevention.
                                                                                                                      [30Day–15–15AMG]                                                              information are encouraged. Your
                                              [FR Doc. 2015–20812 Filed 8–21–15; 8:45 am]
                                                                                                                                                                                                    comments should address any of the
                                              BILLING CODE 4163–18–P                                                  Agency Forms Undergoing Paperwork                                             following: (a) Evaluate whether the
                                                                                                                      Reduction Act Review                                                          proposed collection of information is
                                                                                                                        The Centers for Disease Control and                                         necessary for the proper performance of
tkelley on DSK3SPTVN1PROD with NOTICES




                                                                                                                      Prevention (CDC) has submitted the                                            the functions of the agency, including
                                                                                                                      following information collection request                                      whether the information will have
                                                                                                                      to the Office of Management and Budget                                        practical utility; (b) Evaluate the
                                                                                                                      (OMB) for review and approval in                                              accuracy of the agencies estimate of the
                                                                                                                      accordance with the Paperwork                                                 burden of the proposed collection of
                                                                                                                      Reduction Act of 1995. The notice for                                         information, including the validity of
                                                                                                                      the proposed information collection is                                        the methodology and assumptions used;


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                                                                                 Federal Register / Vol. 80, No. 163 / Monday, August 24, 2015 / Notices                                                      51275

                                              (c) Enhance the quality, utility, and                            United States. It is estimated that each                   gastrointestinal illness in the general
                                              clarity of the information to be                                 year, 48 million Americans (1 in 6)                        population, describe common
                                              collected; (d) Minimize the burden of                            become ill, 128,000 are hospitalized,                      symptoms associated with diarrhea, and
                                              the collection of information on those                           and 3,000 die as the result of a                           determine the proportion of persons
                                              who are to respond, including through                            foodborne illness. Since 1996, the                         with diarrhea who seek medical care.
                                              the use of appropriate automated,                                Foodborne Diseases Active Surveillance                     The survey also collects data on
                                              electronic, mechanical, or other                                 Network (FoodNet) has conducted                            exposures (e.g. food, water, animal
                                              technological collection techniques or                           active population-based surveillance for                   contact) commonly associated with
                                              other forms of information technology,                           Campylobacter, Cryptosporidium,                            foodborne illness. Information about
                                              e.g., permitting electronic submission of                        Cyclospora, Listeria, Salmonella, Shiga                    food exposures in the general public has
                                              responses; and (e) Assess information                            toxin-producing Escherichia coli O157                      proved invaluable during outbreak
                                              collection costs.                                                and non-O157, Shigella, Vibrio, and
                                                 To request additional information on                                                                                     investigations. The ability to compare
                                                                                                               Yersinia infections. Data from FoodNet
                                              the proposed project or to obtain a copy                                                                                    exposures reported by outbreak cases to
                                                                                                               serve as the nation’s ‘‘report card’’ on
                                              of the information collection plan and                                                                                      the ‘background’ exposure in the general
                                                                                                               food safety by monitoring progress
                                              instruments, call (404) 639–7570 or                              toward CDC Healthy People 2020                             population allows investigators to more
                                              send an email to omb@cdc.gov. Written                            objectives.                                                quickly pinpoint a source and enact
                                              comments and/or suggestions regarding                                                                                       control measures. To date, five 12-
                                                                                                                  Evaluation of efforts to control
                                              the items contained in this notice                                                                                          month cycles of the survey have been
                                                                                                               foodborne illnesses can only be done
                                              should be directed to the Attention:                             effectively if there is an accurate                        completed without an existing OMB
                                              CDC Desk Officer, Office of Management                           estimate of the total number of illness                    number: 1996–1997, 1998–1999, 2000–
                                              and Budget, Washington, DC 20503 or                              that occur and if these estimates are                      2001, 2002–2003, and 2006–2007. Data
                                              by fax to (202) 395–5806. Written                                recalculated and monitored over time.                      has been shared with participating state
                                              comments should be received within 30                            Total burden estimates of begin with an                    health departments and multiple
                                              days of this notice.                                             accurate and reliable estimate of the                      programs at CDC, is available to the
                                              Proposed Project                                                 number of acute gastrointestinal illness                   public through a summary report posted
                                                                                                               episodes that occur in the general                         to the FoodNet Web site, and also
                                                FoodNet Population Survey—Existing
                                                                                                               community. To more precisely estimate                      available via individual data requests.
                                              Collection In Use Without an OMB
                                              Control Number—National Center for                               this and to describe the frequency of                      More than two dozen manuscripts
                                              Emerging and Zoonotic Infectious                                 important exposures associated with                        highlighting population survey data
                                              Diseases, Centers for Disease Control                            illness, FoodNet created the Population                    have been published. We seek to
                                              and Prevention (CDC).                                            Survey.                                                    continue this important work.
                                                                                                                  The FoodNet Population Survey is a                        The total annual burden is 6,000
                                              Background and Brief Description                                 survey of persons residing in the                          hours.
                                                Foodborne illnesses represent a                                surveillance area. Data are collected on
                                              significant public health burden in the                          the prevalence and severity of acute

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

                                              U.S. General Population .........................................................   Population Survey ..................     18,000              1            20/60



                                              Leroy A. Richardson,                                             DEPARTMENT OF HEALTH AND                                   concerning each proposed collection of
                                              Chief, Information Collection Review Office,                     HUMAN SERVICES                                             information, including each proposed
                                              Office of Scientific Integrity, Office of the                                                                               extension or reinstatement of an existing
                                              Associate Director for Science, Office of the                    Centers for Medicare & Medicaid                            collection of information, and to allow
                                              Director, Centers for Disease Control and                        Services                                                   a second opportunity for public
                                              Prevention.                                                                                                                 comment on the notice. Interested
                                              [FR Doc. 2015–20811 Filed 8–21–15; 8:45 am]
                                                                                                               [Document Identifier: CMS–10185, CMS–
                                                                                                               10261 and CMS–10561]                                       persons are invited to send comments
                                              BILLING CODE 4163–18–P                                                                                                      regarding the burden estimate or any
                                                                                                               Agency Information Collection                              other aspect of this collection of
                                                                                                               Activities: Submission for OMB                             information, including any of the
                                                                                                               Review; Comment Request                                    following subjects: (1) The necessity and
                                                                                                                                                                          utility of the proposed information
                                                                                                               ACTION:     Notice.                                        collection for the proper performance of
                                                                                                               SUMMARY:  The Centers for Medicare &                       the agency’s functions; (2) the accuracy
                                                                                                                                                                          of the estimated burden; (3) ways to
tkelley on DSK3SPTVN1PROD with NOTICES




                                                                                                               Medicaid Services (CMS) is announcing
                                                                                                               an opportunity for the public to                           enhance the quality, utility, and clarity
                                                                                                               comment on CMS’ intention to collect                       of the information to be collected; and
                                                                                                               information from the public. Under the                     (4) the use of automated collection
                                                                                                               Paperwork Reduction Act of 1995                            techniques or other forms of information
                                                                                                               (PRA), federal agencies are required to                    technology to minimize the information
                                                                                                               publish notice in the Federal Register                     collection burden.


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Document Created: 2015-12-15 10:54:36
Document Modified: 2015-12-15 10:54:36
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 Citation80 FR 51274 

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