81_FR_44998 81 FR 44866 - Agency Forms Undergoing Paperwork Reduction Act Review

81 FR 44866 - Agency Forms Undergoing Paperwork Reduction Act Review

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

Federal Register Volume 81, Issue 132 (July 11, 2016)

Page Range44866-44867
FR Document2016-16298

Federal Register, Volume 81 Issue 132 (Monday, July 11, 2016)
[Federal Register Volume 81, Number 132 (Monday, July 11, 2016)]
[Notices]
[Pages 44866-44867]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-16298]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-16-16ASR]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 
the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (a) 
Evaluate whether the proposed collection of information is necessary 
for the proper performance of the functions of the agency, including 
whether the information will have practical utility; (b) Evaluate the 
accuracy of the agencies estimate of the burden of the proposed 
collection of information, including the validity of the methodology 
and assumptions used; (c) Enhance the quality, utility, and clarity of 
the information to be collected; (d) Minimize the burden of the 
collection of information on those who are to respond, including 
through the use of appropriate automated, electronic, mechanical, or 
other technological collection techniques or other forms of information 
technology, e.g., permitting electronic submission of responses; and 
(e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570 or send an email to omb@cdc.gov. 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

    Persistence of Zika Virus in Semen and Urine of Adult Men in the 
United States with Confirmed Zika Virus Infection--New--National Center 
for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for 
Disease Control and Prevention (CDC).

Background and Brief Description

    Zika virus is an arthropod-borne flavivirus that has recently 
emerged in the Americas. Maternal infection has been linked to 
congenital microcephaly, fetal loss, and other adverse reproductive 
health outcomes. Although spread primarily by mosquitoes, recent 
reports have highlighted the potential for sexual transmission of Zika 
virus through the semen of infected men. Detection of viral RNA in 
semen 62 days after illness onset has been reported; however the 
frequency and duration of virus shedding is largely unknown. 
Information on these parameters is needed urgently to better inform 
public health recommendations, particularly for couples contemplating 
pregnancy.
    This study will fill gaps in the scientific knowledge base for Zika 
virus regarding the persistence and transmissibility of Zika virus in 
body fluids, and determine the frequency and duration of Zika virus 
shedding in semen and urine of infected men. Minimal health information 
and specimens from consenting men with recent Zika virus infection will 
be collected once every two weeks for up to 6 months post onset of 
symptoms (or up to 12 collections). Specimens will be tested for Zika 
RNA by reverse transcriptase polymerase chain reaction assay (RT-PCR) 
at CDC; those testing positive may be further evaluated by virus 
isolation techniques. Zika virus disease is a nationally notifiable 
condition, and participants will be recruited through contact with CDC 
personnel. Urine and semen specimens will be self-collected using home 
collection kits, a short questionnaire will be self-administered, and 
participants will be compensated for their time. Results of testing 
will be provided to participants at the conclusion of testing. The 
results of this study are expected to have immediate implications for 
public health recommendations and disease prevention.
    This is a prospective, descriptive cohort study. The prospective 
nature of the proposed cohort study allows for determining the 
persistence of shedding Zika virus in semen and urine through serial 
specimen collection from individuals with confirmed Zika virus.
    The results of this study will be of great relevance to provide 
evidence-based information to circumvent Zika virus transmission. They 
will inform the development of recommendations used in the current 
epidemic setting, as well as in future Zika virus situations. Results 
and analysis will be used to update and refine relevant counseling 
messages and recommendations.

[[Page 44867]]

Potential products include scientific abstracts and manuscripts, 
presentations, and guidance documents.
    There are no costs to the respondents other than their time. The 
total estimated annual burden hours are 134.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
        Type of respondents                   Form name             respondents    responses per   response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
General Public.....................  Introductory Survey........             250               1           20/60
                                     Follow-up survey...........             250              12            1/60
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Health Scientist, Acting 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. 2016-16298 Filed 7-8-16; 8:45 am]
 BILLING CODE 4163-18-P



                                                44866                              Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Notices

                                                immune response to provide a basis for                          study of individuals with reverse                                messages and recommendations from
                                                development of non-blood-based                                  transcription-polymerase chain reaction                          the CDC.
                                                diagnostic tools, and target and refine                         (RT–PCR) positive ZIKV infection and a                             There are no costs to the respondents
                                                public health interventions to arrest                           cross-sectional study of their household                         other than their time. The total
                                                ongoing spread of infection. To do so,                          contacts. Results and analyses will be                           estimated annual burden hours are 374.
                                                we will conduct a prospective cohort                            used to update relevant counseling

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

                                                Public Health Personnel .........          Shedding Questionnaire (Symptomatics) ...............................                         200               8          10/60
                                                                                           Shedding Questionnaire (Cross-Sectional Asymptomatics) ..                                     400               1          10/60
                                                General Public ........................    Shedding Eligibility Form ........................................................          1,000               1           2/60
                                                                                           Contact Information Form ......................................................               200               1           2/60



                                                Jeffrey M. Zirger,                                              the use of appropriate automated,                                   This study will fill gaps in the
                                                Health Scientist, Acting Chief, Information                     electronic, mechanical, or other                                 scientific knowledge base for Zika virus
                                                Collection Review Office, Office of Scientific                  technological collection techniques or                           regarding the persistence and
                                                Integrity, Office of the Associate Director for                 other forms of information technology,                           transmissibility of Zika virus in body
                                                Science, Office of the Director, Centers for                    e.g., permitting electronic submission of                        fluids, and determine the frequency and
                                                Disease Control and Prevention.                                 responses; and (e) Assess information                            duration of Zika virus shedding in
                                                [FR Doc. 2016–16297 Filed 7–8–16; 8:45 am]                      collection costs.                                                semen and urine of infected men.
                                                BILLING CODE 4163–18–P
                                                                                                                  To request additional information on                           Minimal health information and
                                                                                                                the proposed project or to obtain a copy                         specimens from consenting men with
                                                                                                                of the information collection plan and                           recent Zika virus infection will be
                                                DEPARTMENT OF HEALTH AND                                                                                                         collected once every two weeks for up
                                                HUMAN SERVICES                                                  instruments, call (404) 639–7570 or
                                                                                                                send an email to omb@cdc.gov. Written                            to 6 months post onset of symptoms (or
                                                                                                                comments and/or suggestions regarding                            up to 12 collections). Specimens will be
                                                Centers for Disease Control and                                                                                                  tested for Zika RNA by reverse
                                                Prevention                                                      the items contained in this notice
                                                                                                                should be directed to the Attention:                             transcriptase polymerase chain reaction
                                                [30Day–16–16ASR]                                                CDC Desk Officer, Office of Management                           assay (RT–PCR) at CDC; those testing
                                                                                                                and Budget, Washington, DC 20503 or                              positive may be further evaluated by
                                                Agency Forms Undergoing Paperwork                               by fax to (202) 395–5806. Written                                virus isolation techniques. Zika virus
                                                Reduction Act Review                                            comments should be received within 30                            disease is a nationally notifiable
                                                                                                                days of this notice.                                             condition, and participants will be
                                                   The Centers for Disease Control and                                                                                           recruited through contact with CDC
                                                Prevention (CDC) has submitted the                              Proposed Project                                                 personnel. Urine and semen specimens
                                                following information collection request                                                                                         will be self-collected using home
                                                to the Office of Management and Budget                            Persistence of Zika Virus in Semen
                                                                                                                                                                                 collection kits, a short questionnaire
                                                (OMB) for review and approval in                                and Urine of Adult Men in the United
                                                                                                                                                                                 will be self-administered, and
                                                accordance with the Paperwork                                   States with Confirmed Zika Virus
                                                                                                                                                                                 participants will be compensated for
                                                Reduction Act of 1995. The notice for                           Infection—New—National Center for                                their time. Results of testing will be
                                                the proposed information collection is                          Emerging and Zoonotic Infectious                                 provided to participants at the
                                                published to obtain comments from the                           Diseases (NCEZID), Centers for Disease                           conclusion of testing. The results of this
                                                public and affected agencies.                                   Control and Prevention (CDC).                                    study are expected to have immediate
                                                   Written comments and suggestions                             Background and Brief Description                                 implications for public health
                                                from the public and affected agencies                                                                                            recommendations and disease
                                                concerning the proposed collection of                              Zika virus is an arthropod-borne                              prevention.
                                                information are encouraged. Your                                flavivirus that has recently emerged in                             This is a prospective, descriptive
                                                comments should address any of the                              the Americas. Maternal infection has                             cohort study. The prospective nature of
                                                following: (a) Evaluate whether the                             been linked to congenital microcephaly,                          the proposed cohort study allows for
                                                proposed collection of information is                           fetal loss, and other adverse                                    determining the persistence of shedding
                                                necessary for the proper performance of                         reproductive health outcomes. Although                           Zika virus in semen and urine through
                                                the functions of the agency, including                          spread primarily by mosquitoes, recent                           serial specimen collection from
                                                whether the information will have                               reports have highlighted the potential                           individuals with confirmed Zika virus.
                                                practical utility; (b) Evaluate the                             for sexual transmission of Zika virus                               The results of this study will be of
                                                accuracy of the agencies estimate of the                        through the semen of infected men.                               great relevance to provide evidence-
                                                burden of the proposed collection of                            Detection of viral RNA in semen 62 days                          based information to circumvent Zika
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                                                information, including the validity of                          after illness onset has been reported;                           virus transmission. They will inform the
                                                the methodology and assumptions used;                           however the frequency and duration of                            development of recommendations used
                                                (c) Enhance the quality, utility, and                           virus shedding is largely unknown.                               in the current epidemic setting, as well
                                                clarity of the information to be                                Information on these parameters is                               as in future Zika virus situations.
                                                collected; (d) Minimize the burden of                           needed urgently to better inform public                          Results and analysis will be used to
                                                the collection of information on those                          health recommendations, particularly                             update and refine relevant counseling
                                                who are to respond, including through                           for couples contemplating pregnancy.                             messages and recommendations.


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                                                                                   Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Notices                                                                    44867

                                                Potential products include scientific                              There are no costs to the respondents
                                                abstracts and manuscripts,                                       other than their time. The total
                                                presentations, and guidance documents.                           estimated annual burden hours are 134.

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

                                                General Public ........................    Introductory Survey ................................................................             250                  1               20/60
                                                                                           Follow-up survey ....................................................................            250                 12                1/60



                                                Jeffrey M. Zirger,                                               ADDRESSES:   When commenting on the                                the following proposed collection(s) of
                                                Health Scientist, Acting Chief, Information                      proposed information collections,                                  information for public comment:
                                                Collection Review Office, Office of Scientific                   please reference the document identifier
                                                Integrity, Office of the Associate Director for
                                                                                                                                                                                       1. Type of Information Collection
                                                                                                                 or OMB control number. To be assured                               Request: Revision of a currently
                                                Science, Office of the Director, Centers for                     consideration, comments and
                                                Disease Control and Prevention.                                                                                                     approved collection; Title of
                                                                                                                 recommendations must be received by
                                                [FR Doc. 2016–16298 Filed 7–8–16; 8:45 am]                                                                                          Information Collection: Medicaid Drug
                                                                                                                 the OMB desk officer via one of the
                                                                                                                                                                                    Program—Monthly and Quarterly Drug
                                                BILLING CODE 4163–18–P                                           following transmissions: OMB, Office of
                                                                                                                 Information and Regulatory Affairs,                                Reporting Format; Use: Labelers
                                                                                                                 Attention: CMS Desk Officer, Fax                                   transmit drug product and pricing data
                                                DEPARTMENT OF HEALTH AND                                         Number: (202) 395–5806 or, Email:                                  to CMS within 30 days after the end of
                                                HUMAN SERVICES                                                   OIRA_submission@omb.eop.gov.                                       each calendar month and quarter. CMS
                                                                                                                   To obtain copies of a supporting                                 calculates the unit rebate amount (URA)
                                                Centers for Medicare & Medicaid                                                                                                     and the unit rebate offset amount
                                                Services                                                         statement and any related forms for the
                                                                                                                 proposed collection(s) summarized in                               (UROA) for each new drug application
                                                [Document Identifier: CMS–367]                                   this notice, you may make your request                             (NDC) and distributes to all State
                                                                                                                 using one of following:                                            Medicaid agencies. States use the URA
                                                Agency Information Collection                                                                                                       to invoice the labeler for rebates and the
                                                                                                                   1. Access CMS’ Web site address at
                                                Activities: Submission for OMB                                                                                                      UROA to report onto the CMS–64. The
                                                                                                                 http://www.cms.hhs.gov/Paperwork
                                                Review; Comment Request                                                                                                             monthly data is used to calculate
                                                                                                                 ReductionActof1995.
                                                ACTION:    Notice.                                                 2. Email your request, including your                            Federal Upper Limit (FUL) prices for
                                                                                                                 address, phone number, OMB number,                                 applicable drugs and for states that opt
                                                SUMMARY:    The Centers for Medicare &                           and CMS document identifier, to                                    to use this data to establish their
                                                Medicaid Services (CMS) is announcing                            Paperwork@cms.hhs.gov.                                             pharmacy reimbursement methodology.
                                                an opportunity for the public to                                   3. Call the Reports Clearance Office at                          Form Number: CMS–367 (OMB control
                                                comment on CMS’ intention to collect                             (410) 786–1326.                                                    number: 0938–0578); Frequency:
                                                information from the public. Under the                                                                                              Monthly and Quarterly; Affected Public:
                                                Paperwork Reduction Act of 1995                                  FOR FURTHER INFORMATION CONTACT:
                                                                                                                 Reports Clearance Office at (410) 786–                             Private sector (Business or other for-
                                                (PRA), federal agencies are required to                                                                                             profits); Number of Respondents: 610;
                                                publish a notice in the Federal Register                         1326.
                                                                                                                                                                                    Total Annual Responses: 12,810; Total
                                                concerning each proposed collection of                           SUPPLEMENTARY INFORMATION:     Under the                           Annual Hours: 3,618,703. (For policy
                                                information, including each proposed                             Paperwork Reduction Act of 1995 (PRA)                              questions regarding this collection
                                                extension or reinstatement of an existing                        (44 U.S.C. 3501–3520), federal agencies                            contact Samone Angel at 410–786–
                                                collection of information, and to allow                          must obtain approval from the Office of                            1123.)
                                                a second opportunity for public                                  Management and Budget (OMB) for each
                                                comment on the notice. Interested                                collection of information they conduct                                Dated: July 5, 2016.
                                                persons are invited to send comments                             or sponsor. The term ‘‘collection of                               William N. Parham, III,
                                                regarding the burden estimate or any                             information’’ is defined in 44 U.S.C.                              Director, Paperwork Reduction Staff, Office
                                                other aspect of this collection of                               3502(3) and 5 CFR 1320.3(c) and                                    of Strategic Operations and Regulatory
                                                information, including any of the                                includes agency requests or                                        Affairs.
                                                following subjects: (1) The necessity and                        requirements that members of the public                            [FR Doc. 2016–16221 Filed 7–8–16; 8:45 am]
                                                utility of the proposed information                              submit reports, keep records, or provide                           BILLING CODE 4120–01–P
                                                collection for the proper performance of                         information to a third party. Section
                                                the agency’s functions; (2) the accuracy                         3506(c)(2)(A) of the PRA (44 U.S.C.
                                                of the estimated burden; (3) ways to                             3506(c)(2)(A)) requires federal agencies
                                                enhance the quality, utility, and clarity                        to publish a 30-day notice in the
                                                of the information to be collected; and                          Federal Register concerning each
sradovich on DSK3GDR082PROD with NOTICES




                                                (4) the use of automated collection                              proposed collection of information,
                                                techniques or other forms of information                         including each proposed extension or
                                                technology to minimize the information                           reinstatement of an existing collection
                                                collection burden.                                               of information, before submitting the
                                                DATES: Comments on the collection(s) of                          collection to OMB for approval. To
                                                information must be received by the                              comply with this requirement, CMS is
                                                OMB desk officer by August 10, 2016:                             publishing this notice that summarizes


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Document Created: 2016-07-09 00:21:16
Document Modified: 2016-07-09 00:21:16
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
FR Citation81 FR 44866 

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