Agency Forms Undergoing Paperwork Reduction Act Review, 32554-32556 [2017-14790]
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32554
Federal Register / Vol. 82, No. 134 / Friday, July 14, 2017 / Notices
campus. The REOI specified minimum
and additional functional, geographical,
and environmental criteria that would
be used to evaluate sites for suitability.
In particular, candidate sites were to be
from 10 to 17 acres in size and located
in Cincinnati, within a certain area
(Delineated Area) defined by factors
such as transportation infrastructure,
proximity to other research facilities,
and the residence patterns of current
NIOSH employees.
In response to the REOI, GSA received
seven expressions of interest (i.e.,
Solicited Sites). Following an
assessment of each site based on the
minimum and additional criteria, GSA
found that only one site qualified for
further consideration. During this
screening and assessment process, GSA
identified one additional site (i.e.,
Unsolicited Site) that was added to the
qualifying Solicited Site to create a
larger parcel better capable of
supporting the development of the
proposed campus. The resulting
combined site (i.e., the Site)
encompasses all land between Martin
Luther King Drive East to the south,
Harvey Avenue to the west, Ridgeway
Avenue to the north, and Reading Road
to the east in Cincinnati, Ohio. All other
Solicited Sites were eliminated from
further consideration because they did
not adequately meet the selection
criteria specified in the REOI or, in one
case, were withdrawn from
consideration by the offeror.
In accordance with NEPA, as
implemented by the CEQ regulations (40
CFR parts 1500–1508), CDC is initiating
the preparation of an EIS for the
proposed acquisition of the Site and
construction of a new consolidated
CDC/NIOSH campus on the Site. Under
NEPA, Federal agencies are required to
evaluate the environmental effects of
their proposed actions and a range of
reasonable alternatives to the proposed
action before making a decision. At a
minimum, the EIS will evaluate the
following two alternatives: the Proposed
Action Alternative (acquisition of the
Site and construction of a new
consolidated CDC/NIOSH campus) and
the No Action Alternative (continued
use of the existing campuses for the
foreseeable future).
Scoping Process: In accordance with
NEPA, a public scoping process will be
conducted to establish the range of
issues to be addressed during the
preparation of the EIS. Scoping is an
early and open process for determining
the scope of issues to be addressed and
identifying issues that should be taken
into account in selecting an alternative
for implementation. To that end, during
the scoping process, CDC will actively
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17:44 Jul 13, 2017
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seek input from interested people,
organizations, Federally-recognized
Native American tribes, and Federal,
state, and regional agencies.
The purpose of this Notice is to
inform interested parties regarding
CDC’s plan to prepare an EIS for the
proposed Site acquisition in Cincinnati,
Ohio and the development of the Site
into a new consolidated HHS/CDC/
NIOSH campus; to provide information
on the nature of the Proposed Action;
and to initiate the scoping process. The
public scoping meeting will be held on
August 1, 2017 at the Walnut Hills High
School, 3250 Victory Parkway,
Cincinnati, Ohio 45207, from 6:00 p.m.
to 9:00 p.m. Eastern Time. Attendees
should use the Parking Lot D entrance.
The public scoping meeting will be in
open house format. General information
on the Site and the Proposed Action
will be provided and representatives of
CDC and GSA will be available to
answer one-on-one questions. There
will be no formal presentation or
question-and-answer session.
Participants may arrive at any time
between 6:00 p.m. and 9:00 p.m. Eastern
Time. Comment forms will be provided
for written comments and a
stenographer will be available to
transcribe oral comments. Through the
NEPA scoping process, CDC will also
facilitate consultation with the public as
required by Section 106 of the NHPA.
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.
Dated: July 6, 2017.
Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.
Proposed Project
Zika virus persistence in body fluids
of patients with Zika virus infection in
Puerto Rico (ZIPER Study) (OMB
Control Number 0920–1140, Expiration
Date 10/31/2017)—Revision—National
Center for Emerging and Zoonotic
Infectious Diseases (NCEZID), Centers
for Disease Control and Prevention
(CDC).
[FR Doc. 2017–14474 Filed 7–13–17; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–17–1140]
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
PO 00000
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Fmt 4703
Sfmt 4703
Background and Brief Description
CDC is seeking a one-year OMB
approval to extend the ZIPER Study
information collection.
The Zika Persistence (ZIPER) study
will help inform the presence and
duration of ZIKV shedding in several
body fluids among RT–PCR-positive
ZIKV cases from Puerto Rico. It will also
provide information regarding the
duration of detection of anti-ZIKV IgM
antibodies and the time for development
of IgG antibodies among the same
population. In addition, this study will
determine the prevalence of anti-ZIKV
IgM and IgG, and virus shedding in
body fluids among household contacts
of ZIKV cases.
We propose to investigate the
persistence (shedding) of ZIKV in
different body fluids and its relation to
E:\FR\FM\14JYN1.SGM
14JYN1
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Federal Register / Vol. 82, No. 134 / Friday, July 14, 2017 / 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.
The study will include baseline and
follow-up questionnaires and the
collection of the following specimens:
blood, saliva, urine from participants of
all ages, and semen/vaginal secretions
from adults (ages 21 years or older) and
legally emancipated minors (support
themselves financially, live
independent of their parents, are
pregnant, or have children).
Individuals with RT–PCR positive
ZIKV infection will be recruited through
the Sentinel Enhanced Dengue
Surveillance System (SEDSS) at Saint
Luke’s Episcopal Hospital in Ponce,
Puerto Rico and through passive
surveillance in selected municipalities
in Puerto Rico. SEDSS was established
in 2012 through a cooperative
agreement between the hospital in
Consortium with the Ponce School of
Medicine and Ponce Research Institute
from the Ponce Health Sciences
University and the CDC (Protocol
#6214).
Specimens will be tested for the
presence of ZIKV RNA by RT–PCR at
the CDC Dengue Branch Laboratory in
San Juan, and positive specimens will
be further tested for virus isolation to
evaluate infectivity. Each body fluid
will be collected on a weekly basis for
four weeks and biweekly thereafter until
two consecutive negative RT–PCR
results are obtained from all specimens.
Irrespective of RNA detection, body
fluids will also be collected for RT–PCT
at 2, 4, and 6 months to investigate
intermittent shedding. Analyses of
antibody response through titers of IgM
and IgG will be performed at baseline
and repeated at 2, 4, and 6 months.
Among symptomatic participants
seven milliliters of blood will be drawn
at each study visit split into a tiger top
tube (5ml) and a purple top tube (2ml)
for a total not to exceed 50 ml during
any given 8-week period. At enrollment
healthy non-pregnant adults will have
20 ml of blood collected following
standard procedures. Two tiger top
tubes of 8.5 ml and one 3ml purple top
tubes will be collected. These
procedures will be repeated at each
follow-up visit.
RT–PCR-positive participants will be
asked to refer up to five household
members to establish the percentage of
household members with detectable and
potentially infectious Zika virus RNA in
body fluids. Household members who
are found to be ZIKV RT–PCR-positive
in any body fluid will be invited to
participate in the cohort study. A
second study visit will be scheduled
with household contact at 2 or 4
months, to detect new infections and
estimate incidence. Because the original
study consent forms do not include this
visit, household contacts will be
contacted by study staff and will be
consented again using the same consent
form.
Since gaining OMB approval in
October 2016, the project has enrolled
295 Zika virus-infected individuals into
the Zika virus Persistence study, which
is 55 individuals below the target
enrollment of 350 individuals.
Preliminary findings have been
published in New England Journal of
Medicine, where we also expect that the
final report that includes the full sample
size will be published.
This is a request to continue
information collection with minor
modifications. Modifications have been
made to reflect the developing nature of
the science surrounding Zika virus
infection and potential outcomes
associated with infection, as well as
additional questions that were best
answered by taking advantage of the
existing study platform. Specifically,
CDC proposes the addition of two
components to the collection of data
under this study, one of which has
already begun:
1. A follow-up household visit has
been added to determine how many
household members of Zika virusinfected participants become infected
during the 4 months following initial
screening. For any household members
that had no evidence of Zika virus
infection at the initial visit, the same
questionnaires used at the initial
household visit will again be completed
∼4 months later. Such information will
provide additional information
regarding the incidence of Zika virus
infections among households with a
Zika-positive household member.
2. Additionally, CDC proposes
following up with men with Zika viruspositive semen specimens to better
understand the effect of Zika virus
infection on sperm. To do this, 8–14
semen ejaculates from 10–20 men
participating in the ZIPER study will be
used to determine the presence and/or
detection of the Zika virus in different
fractions of the semen ejaculate (i.e.,
seminal plasma, cellular debris,
including White Blood Cells and
spermatozoa). CDC has received
Institutional Review Board approval for
this modification, but information
collection has not begun.
Authorizing legislation comes from
Section 301 of the Public Health Service
Act (42 U.S.C. 241). The total estimated
annualized number of burden hours is
243. There is no cost to respondents
other than the time to participate.
ESTIMATED ANNUALIZED BURDEN HOURS
Public health personnel ...................
General public .................................
mstockstill on DSK30JT082PROD with NOTICES
Form name
Shedding Questionnaire ....................................
Shedding Questionnaire (Symptomatics) ..........
Shedding
Questionnaire
(Cross-Sectional
Asymptomatics).
Questionnaire for men in Semen sub-study ......
Shedding Eligibility Form ...................................
Contact Information Form ..................................
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Frm 00028
Fmt 4703
Sfmt 4703
Average
burden per
response
(in hours)
Number of
responses per
respondent
Number of
respondents
Type of respondents
18
55
100
30
8
1
15/60
10/60
10/60
30
160
32
1
1
1
20/60
2/60
2/60
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14JYN1
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Federal Register / Vol. 82, No. 134 / Friday, July 14, 2017 / Notices
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2017–14790 Filed 7–13–17; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0369]
Product-Specific Guidances; Draft and
Revised Draft Guidances for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of
additional draft and revised draft
product-specific guidances. The
guidances, when finalized, provide
product-specific recommendations on,
among other things, the design of
bioequivalence (BE) studies to support
abbreviated new drug applications
(ANDAs). In the Federal Register of
June 11, 2010, FDA announced the
availability of a guidance for industry
entitled ‘‘Bioequivalence
Recommendations for Specific
Products’’ that explained the process
that would be used to make productspecific guidances available to the
public on FDA’s Web site. The
guidances identified in this notice were
developed using the process described
in that guidance.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on a draft
guidance announced in this notice
before it begins work on the final
version of the guidance, submit either
electronic or written comments on the
draft guidance by September 12, 2017.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
mstockstill on DSK30JT082PROD with NOTICES
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
VerDate Sep<11>2014
17:44 Jul 13, 2017
Jkt 241001
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2007–D–0369 for ‘‘Product-Specific
Guidances; Draft and Revised Draft
Guidances for Industry.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
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Fmt 4703
Sfmt 4703
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Xiaoqiu Tang, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4730,
Silver Spring, MD 20993–0002, 301–
796–5850.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 11,
2010 (75 FR 33311), FDA announced the
availability of a guidance for industry
entitled ‘‘Bioequivalence
Recommendations for Specific
Products’’ that explained the process
that would be used to make productspecific guidances available to the
public on FDA’s Web site at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm.
As described in that guidance, FDA
adopted this process as a means to
develop and disseminate productspecific guidances and provide a
meaningful opportunity for the public to
consider and comment on those
guidances. Under that process, draft
guidances are posted on FDA’s Web site
E:\FR\FM\14JYN1.SGM
14JYN1
]]>Agencies
[Federal Register Volume 82, Number 134 (Friday, July 14, 2017)]
[Notices]
[Pages 32554-32556]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14790]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-17-1140]
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
Zika virus persistence in body fluids of patients with Zika virus
infection in Puerto Rico (ZIPER Study) (OMB Control Number 0920-1140,
Expiration Date 10/31/2017)--Revision--National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
CDC is seeking a one-year OMB approval to extend the ZIPER Study
information collection.
The Zika Persistence (ZIPER) study will help inform the presence
and duration of ZIKV shedding in several body fluids among RT-PCR-
positive ZIKV cases from Puerto Rico. It will also provide information
regarding the duration of detection of anti-ZIKV IgM antibodies and the
time for development of IgG antibodies among the same population. In
addition, this study will determine the prevalence of anti-ZIKV IgM and
IgG, and virus shedding in body fluids among household contacts of ZIKV
cases.
We propose to investigate the persistence (shedding) of ZIKV in
different body fluids and its relation to
[[Page 32555]]
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.
The study will include baseline and follow-up questionnaires and
the collection of the following specimens: blood, saliva, urine from
participants of all ages, and semen/vaginal secretions from adults
(ages 21 years or older) and legally emancipated minors (support
themselves financially, live independent of their parents, are
pregnant, or have children).
Individuals with RT-PCR positive ZIKV infection will be recruited
through the Sentinel Enhanced Dengue Surveillance System (SEDSS) at
Saint Luke's Episcopal Hospital in Ponce, Puerto Rico and through
passive surveillance in selected municipalities in Puerto Rico. SEDSS
was established in 2012 through a cooperative agreement between the
hospital in Consortium with the Ponce School of Medicine and Ponce
Research Institute from the Ponce Health Sciences University and the
CDC (Protocol #6214).
Specimens will be tested for the presence of ZIKV RNA by RT-PCR at
the CDC Dengue Branch Laboratory in San Juan, and positive specimens
will be further tested for virus isolation to evaluate infectivity.
Each body fluid will be collected on a weekly basis for four weeks and
biweekly thereafter until two consecutive negative RT-PCR results are
obtained from all specimens. Irrespective of RNA detection, body fluids
will also be collected for RT-PCT at 2, 4, and 6 months to investigate
intermittent shedding. Analyses of antibody response through titers of
IgM and IgG will be performed at baseline and repeated at 2, 4, and 6
months.
Among symptomatic participants seven milliliters of blood will be
drawn at each study visit split into a tiger top tube (5ml) and a
purple top tube (2ml) for a total not to exceed 50 ml during any given
8-week period. At enrollment healthy non-pregnant adults will have 20
ml of blood collected following standard procedures. Two tiger top
tubes of 8.5 ml and one 3ml purple top tubes will be collected. These
procedures will be repeated at each follow-up visit.
RT-PCR-positive participants will be asked to refer up to five
household members to establish the percentage of household members with
detectable and potentially infectious Zika virus RNA in body fluids.
Household members who are found to be ZIKV RT-PCR-positive in any body
fluid will be invited to participate in the cohort study. A second
study visit will be scheduled with household contact at 2 or 4 months,
to detect new infections and estimate incidence. Because the original
study consent forms do not include this visit, household contacts will
be contacted by study staff and will be consented again using the same
consent form.
Since gaining OMB approval in October 2016, the project has
enrolled 295 Zika virus-infected individuals into the Zika virus
Persistence study, which is 55 individuals below the target enrollment
of 350 individuals.
Preliminary findings have been published in New England Journal of
Medicine, where we also expect that the final report that includes the
full sample size will be published.
This is a request to continue information collection with minor
modifications. Modifications have been made to reflect the developing
nature of the science surrounding Zika virus infection and potential
outcomes associated with infection, as well as additional questions
that were best answered by taking advantage of the existing study
platform. Specifically, CDC proposes the addition of two components to
the collection of data under this study, one of which has already
begun:
1. A follow-up household visit has been added to determine how many
household members of Zika virus-infected participants become infected
during the 4 months following initial screening. For any household
members that had no evidence of Zika virus infection at the initial
visit, the same questionnaires used at the initial household visit will
again be completed ~4 months later. Such information will provide
additional information regarding the incidence of Zika virus infections
among households with a Zika-positive household member.
2. Additionally, CDC proposes following up with men with Zika
virus-positive semen specimens to better understand the effect of Zika
virus infection on sperm. To do this, 8-14 semen ejaculates from 10-20
men participating in the ZIPER study will be used to determine the
presence and/or detection of the Zika virus in different fractions of
the semen ejaculate (i.e., seminal plasma, cellular debris, including
White Blood Cells and spermatozoa). CDC has received Institutional
Review Board approval for this modification, but information collection
has not begun.
Authorizing legislation comes from Section 301 of the Public Health
Service Act (42 U.S.C. 241). The total estimated annualized number of
burden hours is 243. There is no cost to respondents other than the
time to participate.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Public health personnel......... Shedding Questionnaire.. 18 30 15/60
General public.................. Shedding Questionnaire 55 8 10/60
(Symptomatics).
Shedding Questionnaire 100 1 10/60
(Cross-Sectional
Asymptomatics).
Questionnaire for men in 30 1 20/60
Semen sub-study.
Shedding Eligibility 160 1 2/60
Form.
Contact Information Form 32 1 2/60
----------------------------------------------------------------------------------------------------------------
[[Page 32556]]
Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for Science, Office of the
Director, Centers for Disease Control and Prevention.
[FR Doc. 2017-14790 Filed 7-13-17; 8:45 am]
BILLING CODE 4163-18-P
