81_FR_94185 81 FR 93939 - Proposed Data Collection Submitted for Public Comment and Recommendations

81 FR 93939 - Proposed Data Collection Submitted for Public Comment and Recommendations

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

Federal Register Volume 81, Issue 246 (December 22, 2016)

Page Range93939-93940
FR Document2016-30779

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the National Notifiable Diseases Surveillance System (NNDSS). The NNDSS is the nation's public health surveillance system that monitors the occurrence and spread of diseases and conditions that are nationally notifiable or under national surveillance.

Federal Register, Volume 81 Issue 246 (Thursday, December 22, 2016)
[Federal Register Volume 81, Number 246 (Thursday, December 22, 2016)]
[Notices]
[Pages 93939-93940]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-30779]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-17-0728; Docket No. CDC-2016-0119]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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

SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on the National 
Notifiable Diseases Surveillance System (NNDSS). The NNDSS is the 
nation's public health surveillance system that monitors the occurrence 
and spread of diseases and conditions that are nationally notifiable or 
under national surveillance.

DATES: Written comments must be received on or before February 21, 
2017.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0119 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE., MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.

    Please note: All public comment should be submitted through the 
Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the 
address listed above.


FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact the Information Collection Review Office, 
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; (d) ways to 
minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information.

Proposed Project

    National Notifiable Diseases Surveillance System (OMB Control 
Number 0920-0728, expires 1/31/2019)--Revision--Center for 
Surveillance, Epidemiology and Laboratory Services, CSELS), Centers for 
Disease Control and Prevention (CDC).

Background and Brief Description

    The Public Health Services Act (42 U.S.C. 241) authorizes CDC to 
disseminate nationally notifiable condition information. The Nationally 
Notifiable Diseases Surveillance System (NNDSS) is based on data 
collected at the state, territorial and local levels as a result of 
legislation and regulations in those jurisdictions that require health 
care providers, medical laboratories, and other entities to submit 
health-related data on reportable conditions to public health 
departments. These reportable conditions, which include infectious and 
non-infectious diseases, vary by jurisdiction depending upon each 
jurisdiction's health priorities and needs. Infectious disease agents 
and environmental hazards often cross geographical boundaries. Each 
year, the

[[Page 93940]]

Council of State and Territorial Disease Epidemiologists (CSTE), 
supported by CDC, determines which reportable conditions should be 
designated nationally notifiable and voluntarily submitted to CDC so 
that information can be shared across jurisdictional boundaries and 
both surveillance and prevention and control activities can be 
coordinated at regional and national levels.
    CDC requests a three-year approval for a Revision for the National 
Notifiable Diseases Surveillance System (NNDSS), OMB Control No. 0920-
0728, Expiration Date 01/31/2019. This Revision includes requests for 
approval to receive: (1) Case notification data from the Federated 
States of Micronesia, the Republic of the Marshall Islands, and the 
Republic of Palau (independent nations that operate under a Compact of 
Free Association with the United States of America that are commonly 
referred to as ``freely associated states''); (2) case notification 
data for histoplasmosis which is now under standardized surveillance; 
and (3) case notification data for all enteric Escherichia coli 
infections should any of them become nationally notifiable or be placed 
under standardized surveillance. CDC already has approval to receive 
case notification data for Shiga toxin-producing Escherichia coli 
(STEC) which is nationally notifiable.
    Although this Revision includes case notifications that were not 
part of the last NNDSS Revision, the estimate of the average burden per 
response based on the burden tables from all of the consolidated 
applications for states, cities, and territories has not changed. The 
addition of new diseases and conditions, should they become nationally 
notifiable or be placed under standardized surveillance, will not 
increase the burden since most case notifications are submitted from 
already existing databases. The burden on the states and cities is 
estimated to be 10 hours per response and the burden on the territories 
is estimated to be 5 hours per response. The total burden will increase 
because of the request to receive case notification data from the 
freely associated states. The burden on the freely associated states is 
estimated to be the same as the burden for the territories, 5 hours per 
response. This is because the methods and systems that the freely 
associated states use to send case notification data to CDC are nearly 
the same as the territories.
    There will be no costs to respondents other than their time. The 
estimated annual burden is 29,120 hours.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of      Avg. burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
States........................  Weekly and                    50              52              10          26,000
                                 Annual.
Territories...................  Weekly and                     5              52               5           1,300
                                 Annual.
Freely Associated States......  Weekly and                     3              52               5             780
                                 Annual.
Cities........................  Weekly and                     2              52              10           1,040
                                 Annual.
                               ---------------------------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............          29,120
----------------------------------------------------------------------------------------------------------------


Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2016-30779 Filed 12-21-16; 8:45 am]
 BILLING CODE 4163-18-P



                                                                                Federal Register / Vol. 81, No. 246 / Thursday, December 22, 2016 / Notices                                                                                                 93939

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

                                                Individuals .....................    Cyclosporiasis National Hypothesis Generating                                                  1,000                             1                    45/60                750
                                                                                       Questionnaire.

                                                     Total .......................   ..............................................................................   ........................   ........................   ........................            750



                                                Leroy A. Richardson,                                                   Prevention, 1600 Clifton Road NE., MS–                                        burden of the collection of information
                                                Chief, Information Collection Review Office,                           D74, Atlanta, Georgia 30329.                                                  on respondents, including through the
                                                Office of Scientific Integrity, Office of the                            Instructions: All submissions received                                      use of automated collection techniques
                                                Associate Director for Science, Office of the                          must include the agency name and                                              or other forms of information
                                                Director, Centers for Disease Control and                              Docket Number. All relevant comments                                          technology; and (e) estimates of capital
                                                Prevention.                                                            received will be posted without change                                        or start-up costs and costs of operation,
                                                [FR Doc. 2016–30778 Filed 12–21–16; 8:45 am]                           to Regulations.gov, including any                                             maintenance, and purchase of services
                                                BILLING CODE 4163–18–P                                                 personal information provided. For                                            to provide information. Burden means
                                                                                                                       access to the docket to read background                                       the total time, effort, or financial
                                                                                                                       documents or comments received, go to                                         resources expended by persons to
                                                DEPARTMENT OF HEALTH AND                                               Regulations.gov.                                                              generate, maintain, retain, disclose or
                                                HUMAN SERVICES                                                                                                                                       provide information to or for a Federal
                                                                                                                         Please note: All public comment should be
                                                                                                                       submitted through the Federal eRulemaking                                     agency. This includes the time needed
                                                Centers for Disease Control and                                        portal (Regulations.gov) or by U.S. mail to the                               to review instructions; to develop,
                                                Prevention                                                             address listed above.                                                         acquire, install and utilize technology
                                                                                                                       FOR FURTHER INFORMATION CONTACT:       To                                     and systems for the purpose of
                                                [60Day–17–0728; Docket No. CDC–2016–                                                                                                                 collecting, validating and verifying
                                                0119]                                                                  request more information on the
                                                                                                                       proposed project or to obtain a copy of                                       information, processing and
                                                Proposed Data Collection Submitted                                     the information collection plan and                                           maintaining information, and disclosing
                                                for Public Comment and                                                 instruments, contact the Information                                          and providing information; to train
                                                Recommendations                                                        Collection Review Office, Centers for                                         personnel and to be able to respond to
                                                                                                                       Disease Control and Prevention, 1600                                          a collection of information, to search
                                                AGENCY: Centers for Disease Control and                                Clifton Road NE., MS–D74, Atlanta,                                            data sources, to complete and review
                                                Prevention (CDC), Department of Health                                 Georgia 30329; phone: 404–639–7570;                                           the collection of information; and to
                                                and Human Services (HHS).                                              Email: omb@cdc.gov.                                                           transmit or otherwise disclose the
                                                ACTION: Notice with comment period.                                                                                                                  information.
                                                                                                                       SUPPLEMENTARY INFORMATION: Under the
                                                                                                                       Paperwork Reduction Act of 1995 (PRA)                                         Proposed Project
                                                SUMMARY:   The Centers for Disease
                                                                                                                       (44 U.S.C. 3501–3520), Federal agencies                                         National Notifiable Diseases
                                                Control and Prevention (CDC), as part of
                                                                                                                       must obtain approval from the Office of                                       Surveillance System (OMB Control
                                                its continuing efforts to reduce public
                                                                                                                       Management and Budget (OMB) for each                                          Number 0920–0728, expires 1/31/
                                                burden and maximize the utility of
                                                                                                                       collection of information they conduct                                        2019)—Revision—Center for
                                                government information, invites the
                                                                                                                       or sponsor. In addition, the PRA also                                         Surveillance, Epidemiology and
                                                general public and other Federal
                                                                                                                       requires Federal agencies to provide a                                        Laboratory Services, CSELS), Centers for
                                                agencies to take this opportunity to
                                                                                                                       60-day notice in the Federal Register                                         Disease Control and Prevention (CDC).
                                                comment on proposed and/or
                                                                                                                       concerning each proposed collection of
                                                continuing information collections, as                                                                                                               Background and Brief Description
                                                                                                                       information, including each new
                                                required by the Paperwork Reduction
                                                                                                                       proposed collection, each proposed                                               The Public Health Services Act (42
                                                Act of 1995. This notice invites
                                                                                                                       extension of existing collection of                                           U.S.C. 241) authorizes CDC to
                                                comment on the National Notifiable
                                                                                                                       information, and each reinstatement of                                        disseminate nationally notifiable
                                                Diseases Surveillance System (NNDSS).
                                                                                                                       previously approved information                                               condition information. The Nationally
                                                The NNDSS is the nation’s public health
                                                                                                                       collection before submitting the                                              Notifiable Diseases Surveillance System
                                                surveillance system that monitors the
                                                                                                                       collection to OMB for approval. To                                            (NNDSS) is based on data collected at
                                                occurrence and spread of diseases and
                                                                                                                       comply with this requirement, we are                                          the state, territorial and local levels as
                                                conditions that are nationally notifiable
                                                                                                                       publishing this notice of a proposed                                          a result of legislation and regulations in
                                                or under national surveillance.
                                                                                                                       data collection as described below.                                           those jurisdictions that require health
                                                DATES: Written comments must be                                           Comments are invited on: (a) Whether                                       care providers, medical laboratories,
                                                received on or before February 21, 2017.                               the proposed collection of information                                        and other entities to submit health-
                                                ADDRESSES: You may submit comments,                                    is necessary for the proper performance                                       related data on reportable conditions to
                                                identified by Docket No. CDC–2016–                                     of the functions of the agency, including                                     public health departments. These
sradovich on DSK3GMQ082PROD with NOTICES




                                                0119 by any of the following methods:                                  whether the information shall have                                            reportable conditions, which include
                                                   • Federal eRulemaking Portal:                                       practical utility; (b) the accuracy of the                                    infectious and non-infectious diseases,
                                                Regulations.gov. Follow the instructions                               agency’s estimate of the burden of the                                        vary by jurisdiction depending upon
                                                for submitting comments.                                               proposed collection of information; (c)                                       each jurisdiction’s health priorities and
                                                   • Mail: Leroy A. Richardson,                                        ways to enhance the quality, utility, and                                     needs. Infectious disease agents and
                                                Information Collection Review Office,                                  clarity of the information to be                                              environmental hazards often cross
                                                Centers for Disease Control and                                        collected; (d) ways to minimize the                                           geographical boundaries. Each year, the


                                           VerDate Sep<11>2014      17:40 Dec 21, 2016       Jkt 241001        PO 00000        Frm 00059        Fmt 4703        Sfmt 4703      E:\FR\FM\22DEN1.SGM               22DEN1


                                                93940                              Federal Register / Vol. 81, No. 246 / Thursday, December 22, 2016 / Notices

                                                Council of State and Territorial Disease                                  with the United States of America that                                        nationally notifiable or be placed under
                                                Epidemiologists (CSTE), supported by                                      are commonly referred to as ‘‘freely                                          standardized surveillance, will not
                                                CDC, determines which reportable                                          associated states’’); (2) case notification                                   increase the burden since most case
                                                conditions should be designated                                           data for histoplasmosis which is now                                          notifications are submitted from already
                                                nationally notifiable and voluntarily                                     under standardized surveillance; and (3)                                      existing databases. The burden on the
                                                submitted to CDC so that information                                      case notification data for all enteric                                        states and cities is estimated to be 10
                                                can be shared across jurisdictional                                       Escherichia coli infections should any                                        hours per response and the burden on
                                                boundaries and both surveillance and                                      of them become nationally notifiable or                                       the territories is estimated to be 5 hours
                                                prevention and control activities can be                                  be placed under standardized                                                  per response. The total burden will
                                                coordinated at regional and national                                      surveillance. CDC already has approval                                        increase because of the request to
                                                levels.                                                                   to receive case notification data for                                         receive case notification data from the
                                                  CDC requests a three-year approval for                                  Shiga toxin-producing Escherichia coli                                        freely associated states. The burden on
                                                a Revision for the National Notifiable                                    (STEC) which is nationally notifiable.                                        the freely associated states is estimated
                                                Diseases Surveillance System (NNDSS),                                        Although this Revision includes case                                       to be the same as the burden for the
                                                OMB Control No. 0920–0728, Expiration                                     notifications that were not part of the                                       territories, 5 hours per response. This is
                                                Date 01/31/2019. This Revision includes                                   last NNDSS Revision, the estimate of the                                      because the methods and systems that
                                                requests for approval to receive: (1) Case                                average burden per response based on                                          the freely associated states use to send
                                                notification data from the Federated                                      the burden tables from all of the                                             case notification data to CDC are nearly
                                                States of Micronesia, the Republic of the                                 consolidated applications for states,                                         the same as the territories.
                                                Marshall Islands, and the Republic of                                     cities, and territories has not changed.                                         There will be no costs to respondents
                                                Palau (independent nations that operate                                   The addition of new diseases and                                              other than their time. The estimated
                                                under a Compact of Free Association                                       conditions, should they become                                                annual burden is 29,120 hours.

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

                                                States ................................................    Weekly      and     Annual       ..........................                       50                         52                         10           26,000
                                                Territories ..........................................     Weekly      and     Annual       ..........................                        5                         52                          5            1,300
                                                Freely Associated States ..................                Weekly      and     Annual       ..........................                        3                         52                          5              780
                                                Cities .................................................   Weekly      and     Annual       ..........................                        2                         52                         10            1,040

                                                      Total ...........................................    ...........................................................   ........................   ........................   ........................         29,120



                                                Leroy A. Richardson,                                                      level of 10 parts per million (ppm) for                                       instructions for submitting comments.
                                                Chief, Information Collection Review Office,                              lead as an impurity in cosmetic lip                                           Comments submitted electronically,
                                                Office of Scientific Integrity, Office of the                             products (such as lipsticks, lip glosses,                                     including attachments, to https://
                                                Associate Director for Science, Office of the                             and lip liners) and externally applied                                        www.regulations.gov will be posted to
                                                Director, Centers for Disease Control and                                 cosmetics (such as eye shadows,                                               the docket unchanged. Because your
                                                Prevention.                                                               blushes, shampoos, and body lotions)                                          comment will be made public, you are
                                                [FR Doc. 2016–30779 Filed 12–21–16; 8:45 am]                              marketed in the United States. We                                             solely responsible for ensuring that your
                                                BILLING CODE 4163–18–P                                                    consider the recommended maximum                                              comment does not include any
                                                                                                                          lead level to be achievable with the use                                      confidential information that you or a
                                                                                                                          of good manufacturing practices and                                           third party may not wish to be posted,
                                                DEPARTMENT OF HEALTH AND                                                  consistent with the 10 ppm maximum                                            such as medical information, your or
                                                HUMAN SERVICES                                                            lead level for similar products                                               anyone else’s Social Security number, or
                                                                                                                          recommended by other countries, and                                           confidential business information, such
                                                Food and Drug Administration                                                                                                                            as a manufacturing process. Please note
                                                                                                                          we have concluded that the
                                                [Docket No. FDA–2014–D–2275]                                              recommended maximum lead level                                                that if you include your name, contact
                                                                                                                          would not pose a health risk.                                                 information, or other information that
                                                Lead in Cosmetic Lip Products and                                         DATES: Although you can comment on
                                                                                                                                                                                                        identifies you in the body of your
                                                Externally Applied Cosmetics:                                             any guidance at any time (see 21 CFR                                          comments, that information will be
                                                Recommended Maximum Level; Draft                                          10.115(g)(5)), to ensure that we consider                                     posted on https://www.regulations.gov.
                                                Guidance for Industry; Availability                                                                                                                       • If you want to submit a comment
                                                                                                                          your comment on this draft guidance
                                                                                                                                                                                                        with confidential information that you
                                                AGENCY:        Food and Drug Administration,                              before we begin work on the final
                                                                                                                                                                                                        do not wish to be made available to the
                                                HHS.                                                                      version of the guidance, submit either
                                                                                                                                                                                                        public, submit the comment as a
                                                                                                                          electronic or written comments on the
                                                ACTION:      Notice of availability.                                                                                                                    written/paper submission and in the
                                                                                                                          draft guidance by February 21, 2017.
                                                                                                                                                                                                        manner detailed (see ‘‘Written/Paper
                                                SUMMARY:  The Food and Drug
sradovich on DSK3GMQ082PROD with NOTICES




                                                                                                                          ADDRESSES: You may submit comments                                            Submissions’’ and ‘‘Instructions’’).
                                                Administration (FDA or we) is                                             as follows:
                                                announcing the availability of a draft                                                                                                                  Written/Paper Submissions
                                                                                                                          Electronic Submissions
                                                guidance for industry entitled, ‘‘Lead in                                                                                                                 Submit written/paper submissions as
                                                Cosmetic Lip Products and Externally                                        Submit electronic comments in the                                           follows:
                                                Applied Cosmetics: Recommended                                            following way:                                                                  • Mail/Hand delivery/Courier (for
                                                Maximum Level.’’ This draft guidance                                        • Federal eRulemaking Portal:                                               written/paper submissions): Division of
                                                provides a recommended maximum                                            https://www.regulations.gov. Follow the                                       Dockets Management (HFA–305), Food


                                           VerDate Sep<11>2014         17:40 Dec 21, 2016        Jkt 241001       PO 00000        Frm 00060        Fmt 4703        Sfmt 4703      E:\FR\FM\22DEN1.SGM               22DEN1



Document Created: 2016-12-21 23:52:44
Document Modified: 2016-12-21 23:52:44
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
ActionNotice with comment period.
DatesWritten comments must be received on or before February 21, 2017.
ContactTo request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS- D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected]
FR Citation81 FR 93939 

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR