Agency Forms Undergoing Paperwork Reduction Act Review, 44866-44867 [2016-16298]
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44866
Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Notices
immune response to provide a basis for
development of non-blood-based
diagnostic tools, and target and refine
public health interventions to arrest
ongoing spread of infection. To do so,
we will conduct a prospective cohort
study of individuals with reverse
transcription-polymerase chain reaction
(RT–PCR) positive ZIKV infection and a
cross-sectional study of their household
contacts. Results and analyses will be
used to update relevant counseling
messages and recommendations from
the CDC.
There are no costs to the respondents
other than their time. The total
estimated annual burden hours are 374.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Public Health Personnel .........
Shedding Questionnaire (Symptomatics) ...............................
Shedding Questionnaire (Cross-Sectional Asymptomatics) ..
Shedding Eligibility Form ........................................................
Contact Information Form ......................................................
General Public ........................
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. 2016–16297 Filed 7–8–16; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–16–16ASR]
sradovich on DSK3GDR082PROD with NOTICES
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
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Jkt 238001
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.
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
200
400
1,000
200
Number of
responses per
respondent
8
1
1
1
Average
burden per
response
(in hours)
10/60
10/60
2/60
2/60
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 evidencebased 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.
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44867
Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Notices
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
Number of
respondents
Type of respondents
Form name
General Public ........................
Introductory Survey ................................................................
Follow-up survey ....................................................................
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–367]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
ACTION:
Notice.
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish a notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
DATES: Comments on the collection(s) of
information must be received by the
OMB desk officer by August 10, 2016:
sradovich on DSK3GDR082PROD with NOTICES
SUMMARY:
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When commenting on the
proposed information collections,
please reference the document identifier
or OMB control number. To be assured
consideration, comments and
recommendations must be received by
the OMB desk officer via one of the
following transmissions: OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
Number: (202) 395–5806 or, Email:
OIRA_submission@omb.eop.gov.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ Web site address at
https://www.cms.hhs.gov/Paperwork
ReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
Reports Clearance Office at (410) 786–
1326.
ADDRESSES:
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. The term ‘‘collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and
includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
SUPPLEMENTARY INFORMATION:
PO 00000
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Fmt 4703
Sfmt 9990
Number of
responses per
respondent
250
250
Average
burden per
response
(in hours)
1
12
20/60
1/60
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Medicaid Drug
Program—Monthly and Quarterly Drug
Reporting Format; Use: Labelers
transmit drug product and pricing data
to CMS within 30 days after the end of
each calendar month and quarter. CMS
calculates the unit rebate amount (URA)
and the unit rebate offset amount
(UROA) for each new drug application
(NDC) and distributes to all State
Medicaid agencies. States use the URA
to invoice the labeler for rebates and the
UROA to report onto the CMS–64. The
monthly data is used to calculate
Federal Upper Limit (FUL) prices for
applicable drugs and for states that opt
to use this data to establish their
pharmacy reimbursement methodology.
Form Number: CMS–367 (OMB control
number: 0938–0578); Frequency:
Monthly and Quarterly; Affected Public:
Private sector (Business or other forprofits); Number of Respondents: 610;
Total Annual Responses: 12,810; Total
Annual Hours: 3,618,703. (For policy
questions regarding this collection
contact Samone Angel at 410–786–
1123.)
Dated: July 5, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2016–16221 Filed 7–8–16; 8:45 am]
BILLING CODE 4120–01–P
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]]>Agencies
[Federal Register Volume 81, Number 132 (Monday, July 11, 2016)]
[Notices]
[Pages 44866-44867]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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
