82_FR_41583 82 FR 41415 - Agency Forms Undergoing Paperwork Reduction Act Review

82 FR 41415 - Agency Forms Undergoing Paperwork Reduction Act Review

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

Federal Register Volume 82, Issue 168 (August 31, 2017)

Page Range41415-41416
FR Document2017-18512

Federal Register, Volume 82 Issue 168 (Thursday, August 31, 2017)
[Federal Register Volume 82, Number 168 (Thursday, August 31, 2017)]
[Notices]
[Pages 41415-41416]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-18512]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-17-0607]


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 agency's 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

    The National Violent Death Reporting System (NVDRS)(OMB Control 
Number 0920-0607, expiration 10/31/2017)--Revision--National Center for 
Injury Prevention and Control (NCIPC), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    Violence is a public health problem. The World Health Organization 
has estimated that 804,000 suicides and 475,000 homicides occurred in 
the year 2012 worldwide. Violence in the United States is a particular 
problem for the young; suicide and homicide were among the top 4 
leading causes of death for Americans 10-34 and 1-34 years of age in 
2015, respectively. In 2002 Congress approved the first appropriation 
to start the National Violent Death Reporting System (NVDRS). NVDRS is 
coordinated and funded at the federal level but is dependent on 
separate data collection efforts managed by the state health department 
(or their bona fide agent) in each state.
    NVDRS is an ongoing surveillance system that captures annual 
violent death counts and circumstances that precipitate each violent 
incident. Data on violent death is defined as a death resulting from 
the intentional use of physical force or power (e.g., threats or 
intimidation) against oneself, another person, or against a group or 
community. CDC aggregates de-identified data from each state into one 
large national database that is analyzed and released in annual reports 
and publications. Descriptive analyses such as frequencies and rates 
are employed. A restricted access database is available for researchers 
to request access to NVDRS data for analysis and a web-based query 
system is open for public use that allows for electronic querying of 
data. NVDRS generates public health surveillance information at the 
national, state, and local levels that is more detailed, useful, and 
timely. Government, state and local communities have used NVDRS data to 
develop and evaluate prevention programs and strategies. NVDRS is also 
used to understand magnitude, trends, and characteristics of violent 
death and what factors protect people or put them at risk for 
experiencing violence.
    This is a revision request for an additional three years to 
continue data collection efforts of the currently approved information 
collection project. The purpose of this revision is to (1) implement 
updates to the web-based system to improve performance, functionality, 
and accessibility; (2) add new data elements to the system and minimal 
revisions to the NVDRS coding manual; (3) modify burden hours to 
account for the increase in violent deaths in the U.S. since 2003; and 
(4) to decrease the number of funded reporting state health departments 
from 58 to 56.
    The estimated annual burden hours are 34,250. There are no costs to 
respondents.

[[Page 41416]]



                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                Total number of  Average  burden
         Type of respondent                  Form name            Number of      responses per    per  response
                                                                 respondents       respondent       (in hours)
----------------------------------------------------------------------------------------------------------------
Public Agencies.....................  Retrieving and refile                56            1,223            30/60
                                       records.
----------------------------------------------------------------------------------------------------------------


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. 2017-18512 Filed 8-30-17; 8:45 am]
BILLING CODE 4163-18-P



                                                                            Federal Register / Vol. 82, No. 168 / Thursday, August 31, 2017 / Notices                                          41415

                                                or bank holding company. The factors                    accordance with the Paperwork                         for Americans 10–34 and 1–34 years of
                                                that are considered in acting on the                    Reduction Act of 1995. The notice for                 age in 2015, respectively. In 2002
                                                notices are set forth in paragraph 7 of                 the proposed information collection is                Congress approved the first
                                                the Act (12 U.S.C. 1817(j)(7)).                         published to obtain comments from the                 appropriation to start the National
                                                   The notices are available for                        public and affected agencies.                         Violent Death Reporting System
                                                immediate inspection at the Federal                        Written comments and suggestions                   (NVDRS). NVDRS is coordinated and
                                                Reserve Bank indicated. The notices                     from the public and affected agencies                 funded at the federal level but is
                                                also will be available for inspection at                concerning the proposed collection of                 dependent on separate data collection
                                                the offices of the Board of Governors.                  information are encouraged. Your                      efforts managed by the state health
                                                Interested persons may express their                    comments should address any of the                    department (or their bona fide agent) in
                                                views in writing to the Reserve Bank                    following: (a) Evaluate whether the                   each state.
                                                indicated for that notice or to the offices             proposed collection of information is
                                                                                                        necessary for the proper performance of                  NVDRS is an ongoing surveillance
                                                of the Board of Governors. Comments
                                                                                                        the functions of the agency, including                system that captures annual violent
                                                must be received not later than
                                                                                                        whether the information will have                     death counts and circumstances that
                                                September 14, 2017.
                                                                                                        practical utility; (b) Evaluate the                   precipitate each violent incident. Data
                                                   A. Federal Reserve Bank of Chicago
                                                                                                        accuracy of the agency’s estimate of the              on violent death is defined as a death
                                                (Colette A. Fried, Assistant Vice
                                                                                                        burden of the proposed collection of                  resulting from the intentional use of
                                                President) 230 South LaSalle Street,
                                                                                                        information, including the validity of                physical force or power (e.g., threats or
                                                Chicago, Illinois 60690–1414:
                                                   1. James C. Volkert, individually and                the methodology and assumptions used;                 intimidation) against oneself, another
                                                as trustee of the James C. Volkert                      (c) Enhance the quality, utility, and                 person, or against a group or
                                                Revocable Living Trust, the James C.                    clarity of the information to be                      community. CDC aggregates de-
                                                Volkert Revocable Living Trust, Susan                   collected; (d) Minimize the burden of                 identified data from each state into one
                                                A. Volkert, Jacquelyn Volkert, and                      the collection of information on those                large national database that is analyzed
                                                Michael Volkert, all of Montgomery,                     who are to respond, including through                 and released in annual reports and
                                                Illinois; as a group acting in concert to               the use of appropriate automated,                     publications. Descriptive analyses such
                                                retain voting shares of Montgomery                      electronic, mechanical, or other                      as frequencies and rates are employed.
                                                Bancshares, Inc., and thereby indirectly                technological collection techniques or                A restricted access database is available
                                                retain voting shares of Bank of                         other forms of information technology,                for researchers to request access to
                                                Montgomery, both in Montgomery,                         e.g., permitting electronic submission of             NVDRS data for analysis and a web-
                                                Illinois.                                               responses; and (e) Assess information                 based query system is open for public
                                                   B. Federal Reserve Bank of Kansas                    collection costs.                                     use that allows for electronic querying
                                                City (Dennis Denney, Assistant Vice                        To request additional information on               of data. NVDRS generates public health
                                                President) 1 Memorial Drive, Kansas                     the proposed project or to obtain a copy              surveillance information at the national,
                                                City, Missouri 64198–0001:                              of the information collection plan and                state, and local levels that is more
                                                   1. Jeff Schumacher, Lincoln,                         instruments, call (404) 639–7570 or                   detailed, useful, and timely.
                                                Nebraska; to acquire voting shares of                   send an email to omb@cdc.gov. Written                 Government, state and local
                                                North Central Bancorp, Inc., and thereby                comments and/or suggestions regarding                 communities have used NVDRS data to
                                                indirectly acquire BankFirst, both in                   the items contained in this notice                    develop and evaluate prevention
                                                Norfolk, Nebraska.                                      should be directed to the Attention:                  programs and strategies. NVDRS is also
                                                                                                        CDC Desk Officer, Office of Management                used to understand magnitude, trends,
                                                  Board of Governors of the Federal Reserve             and Budget, Washington, DC 20503 or                   and characteristics of violent death and
                                                System, August 25, 2017.
                                                                                                        by fax to (202) 395–5806. Written                     what factors protect people or put them
                                                Yao-Chin Chao,                                          comments should be received within 30                 at risk for experiencing violence.
                                                Assistant Secretary of the Board.                       days of this notice.                                     This is a revision request for an
                                                [FR Doc. 2017–18445 Filed 8–30–17; 8:45 am]
                                                                                                        Proposed Project                                      additional three years to continue data
                                                BILLING CODE 6210–01–P
                                                                                                                                                              collection efforts of the currently
                                                                                                          The National Violent Death Reporting
                                                                                                                                                              approved information collection project.
                                                                                                        System (NVDRS)(OMB Control Number
                                                                                                                                                              The purpose of this revision is to (1)
                                                DEPARTMENT OF HEALTH AND                                0920–0607, expiration 10/31/2017)—
                                                                                                                                                              implement updates to the web-based
                                                HUMAN SERVICES                                          Revision—National Center for Injury
                                                                                                                                                              system to improve performance,
                                                                                                        Prevention and Control (NCIPC),
                                                                                                                                                              functionality, and accessibility; (2) add
                                                Centers for Disease Control and                         Centers for Disease Control and
                                                                                                                                                              new data elements to the system and
                                                Prevention                                              Prevention (CDC).
                                                                                                                                                              minimal revisions to the NVDRS coding
                                                [30Day–17–0607]                                         Background and Brief Description                      manual; (3) modify burden hours to
                                                                                                          Violence is a public health problem.                account for the increase in violent
                                                Agency Forms Undergoing Paperwork                                                                             deaths in the U.S. since 2003; and (4) to
                                                Reduction Act Review                                    The World Health Organization has
                                                                                                        estimated that 804,000 suicides and                   decrease the number of funded
                                                  The Centers for Disease Control and                   475,000 homicides occurred in the year                reporting state health departments from
                                                Prevention (CDC) has submitted the                      2012 worldwide. Violence in the United                58 to 56.
                                                following information collection request                States is a particular problem for the                   The estimated annual burden hours
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                                                to the Office of Management and Budget                  young; suicide and homicide were                      are 34,250. There are no costs to
                                                (OMB) for review and approval in                        among the top 4 leading causes of death               respondents.




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                                                41416                             Federal Register / Vol. 82, No. 168 / Thursday, August 31, 2017 / Notices

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

                                                Public Agencies ..............................................   Retrieving and refile records ..........................       56               1,223         30/60



                                                Leroy A. Richardson,                                              confidential information that you or a                     Agency will review this copy, including
                                                Chief, Information Collection Review Office,                      third party may not wish to be posted,                     the claimed confidential information, in
                                                Office of Scientific Integrity, Office of the                     such as medical information, your or                       its consideration of comments. The
                                                Associate Director for Science, Office of the                     anyone else’s Social Security number, or                   second copy, which will have the
                                                Director, Centers for Disease Control and                         confidential business information, such                    claimed confidential information
                                                Prevention.                                                                                                                  redacted/blacked out, will be available
                                                                                                                  as a manufacturing process. Please note
                                                [FR Doc. 2017–18512 Filed 8–30–17; 8:45 am]                       that if you include your name, contact                     for public viewing and posted on
                                                BILLING CODE 4163–18–P                                            information, or other information that                     https://www.regulations.gov. Submit
                                                                                                                  identifies you in the body of your                         both copies to the Dockets Management
                                                                                                                  comments, that information will be                         Staff. If you do not wish your name and
                                                DEPARTMENT OF HEALTH AND                                          posted on https://www.regulations.gov.                     contact information to be made publicly
                                                HUMAN SERVICES                                                      • If you want to submit a comment                        available, you can provide this
                                                                                                                  with confidential information that you                     information on the cover sheet and not
                                                Food and Drug Administration
                                                                                                                  do not wish to be made available to the                    in the body of your comments and you
                                                [Docket No. FDA–2017–N–4565]                                      public, submit the comment as a                            must identify this information as
                                                                                                                  written/paper submission and in the                        ‘‘confidential.’’ Any information marked
                                                Electronic Study Data Submission;                                 manner detailed (see ‘‘Written/Paper                       as ‘‘confidential’’ will not be disclosed
                                                Data Standards; Support for Version                               Submissions’’ and ‘‘Instructions’’).                       except in accordance with 21 CFR 10.20
                                                Update of the Medical Dictionary for                                                                                         and other applicable disclosure law. For
                                                Regulatory Activities                                             Written/Paper Submissions                                  more information about FDA’s posting
                                                AGENCY:      Food and Drug Administration,                           Submit written/paper submissions as                     of comments to public dockets, see 80
                                                HHS.                                                              follows:                                                   FR 56469, September 18, 2015, or access
                                                ACTION:     Notice.                                                  • Mail/Hand delivery/Courier (for                       the information at: https://www.gpo.gov/
                                                                                                                  written/paper submissions): Dockets                        fdsys/pkg/FR-2015-09-18/pdf/2015-
                                                SUMMARY:   The Food and Drug                                      Management Staff (HFA–305), Food and                       23389.pdf.
                                                Administration (FDA or Agency) is                                 Drug Administration, 5630 Fishers                             Docket: For access to the docket to
                                                announcing support for the most current                           Lane, Rm. 1061, Rockville, MD 20852.                       read background documents or the
                                                version of Medical Dictionary for                                    • For written/paper comments                            electronic and written/paper comments
                                                Regulatory Activities (MedDRA), end of                            submitted to the Dockets Management                        received, go to https://
                                                support for earlier versions of MedDRA,                           Staff, FDA will post your comment, as                      www.regulations.gov and insert the
                                                and an update to the FDA Data                                     well as any attachments, except for                        docket number, found in brackets in the
                                                Standards Catalog (Catalog) for study                             information submitted, marked and                          heading of this document, into the
                                                data provided in new drug applications                            identified, as confidential, if submitted                  ‘‘Search’’ box and follow the prompts
                                                (NDAs), abbreviated new drug                                      as detailed in ‘‘Instructions.’’                           and/or go to the Dockets Management
                                                applications (ANDAs), biologics license                              Instructions: All submissions received                  Staff, 5630 Fishers Lane, Rm. 1061,
                                                applications (BLAs), and investigational                          must include the Docket No. FDA–                           Rockville, MD 20852.
                                                new drug applications (INDs) to the                               2017–N–4565 for ‘‘Electronic Study                         FOR FURTHER INFORMATION CONTACT: Ron
                                                Center for Biologics Evaluation and                               Data Submission; Data Standards;                           Fitzmartin, Center for Drug Evaluation
                                                Research (CBER) and the Center for                                Support for Version Update of the                          and Research, Food and Drug
                                                Drug Evaluation and Research (CDER).                              Medical Dictionary for Regulatory                          Administration, 10903 New Hampshire
                                                DATES: Submit either electronic or                                Activities.’’ Received comments will be                    Ave., Bldg. 51, Rm. 1115, Silver Spring,
                                                written comments on this document at                              placed in the docket and, except for                       MD 20993–0002, 301–796–5333,
                                                any time.                                                         those submitted as ‘‘Confidential                          cderdatastandards@fda.hhs.gov; or
                                                ADDRESSES: You may submit comments                                Submissions,’’ publicly viewable at                        Stephen Ripley, Center for Biologics
                                                as follows:                                                       https://www.regulations.gov or at the                      Evaluation and Research, Food and
                                                                                                                  Dockets Management Staff between 9                         Drug Administration, 10903 New
                                                Electronic Submission                                             a.m. and 4 p.m., Monday through                            Hampshire Ave., Bldg. 71, Rm. 7268,
                                                  Submit electronic comments in the                               Friday.                                                    Silver Spring, MD 20993–0002, 240–
                                                following way:                                                       • Confidential Submissions—To                           402–7911, stephen.ripley@fda.hhs.gov.
                                                  • Federal eRulemaking Portal:                                   submit a comment with confidential                         SUPPLEMENTARY INFORMATION: On
                                                https://www.regulations.gov. Follow the                           information that you do not wish to be                     December 17, 2014, FDA published final
                                                instructions for submitting comments.                             made publicly available, submit your                       guidance for industry ‘‘Providing
sradovich on DSK3GMQ082PROD with NOTICES




                                                Comments submitted electronically,                                comments only as a written/paper                           Regulatory Submissions in Electronic
                                                including attachments, to https://                                submission. You should submit two                          Format—Standardized Study Data’’
                                                www.regulations.gov will be posted to                             copies total. One copy will include the                    (eStudy Data) posted on FDA’s Study
                                                the docket unchanged. Because your                                information you claim to be confidential                   Data Standards Resources Web page at
                                                comment will be made public, you are                              with a heading or cover note that states                   https://www.fda.gov/forindustry/
                                                solely responsible for ensuring that your                         ‘‘THIS DOCUMENT CONTAINS                                   datastandards/studydatastandards/
                                                comment does not include any                                      CONFIDENTIAL INFORMATION.’’ The                            default.htm. The eStudy Data guidance


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Document Created: 2017-09-23 10:08:20
Document Modified: 2017-09-23 10:08:20
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 41415 

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