Agency Forms Undergoing Paperwork Reduction Act Review, 26931-26933 [2017-12060]
Download as PDF
<![CDATA[
26931
Federal Register / Vol. 82, No. 111 / Monday, June 12, 2017 / Notices
Colombia’s Instituto Nacional de
Salud (INS) began surveillance for ZIKV
in 2015, reporting the first
autochthonous transmission in October
2015 in the north of the country. As of
October 2016, Colombia has reported
over 105,000 suspected ZIKV cases,
with over 19,000 of them among
pregnant women. With a causal link
established between ZIKV infection in
pregnancy and microcephaly, there is an
urgent need to understand: How ZIKV
transmission can be prevented; the full
spectrum of adverse maternal, fetal, and
infant health outcomes associated with
ZIKV infection; and risk factors for
occurrence of these outcomes. To
answer these questions, INS and the
U.S. Centers for Disease Control and
Prevention (CDC) will follow 5,000
women enrolled in the first trimester of
pregnancy, their male partners, and
their infants, in various cities in
Colombia where ZIKV transmission is
currently ongoing.
The primary study objectives are to:
(1) Describe the sociodemographic and
clinical characteristics of the study
population; (2) Identify risk factors for
ZIKV infection in pregnant women and
their infants. These include behaviors
such as use of mosquito-bite prevention
measures or condoms, and factors
associated with maternal-to-child
transmission; (3) Assess the risk for
adverse maternal, fetal, and infant
outcomes associated with ZIKV
infection; (4) Assess modifiers of the
risk for adverse outcomes among
pregnant women and their infants
following ZIKV infection. This includes
investigating associations with
gestational age at infection, presence of
ZIKV symptoms, extended viremia,
mode of transmission, prior infections
or immunizations, and co-infections.
The project aims to enroll
approximately 5,000 women, 1,250 male
partners, and 4,500 newborns. Pregnant
women will be recruited in the first
trimester of pregnancy for study
enrollment, followed by assessments
during pregnancy (every other week
until 32 weeks gestation and monthly
thereafter), and within 10 days
postpartum. At all visits, participants
will complete visit-specific
questionnaires. In addition to the
questionnaires, at all pregnancy and
delivery visits, participants will receive
Colombian national recommended
clinical care and provide samples for
laboratory testing.
Male partners will be recruited
around the time of the pregnant
partners’ study enrollment, followed by
monthly visits until his pregnant
partner reaches the third trimester
(approximately 27 weeks gestation). If
the male partner contracts ZIKV during
this time, visits will occur every other
week until the partner has two negative
consecutive tests for ZIKV or the
pregnancy ends. At all study visits, male
partners will complete visit-specific
questionnaires and provide samples for
laboratory testing.
All newborns of mothers participating
in the study will be followed every
other week from birth to 6 months of
age. At all visits, infants will receive
national recommended clinical care (at
birth and clinic visits at 1, 2, and 6
months), provide samples for laboratory
testing, and mothers will complete
study-specific questionnaires about
infant ZIKV symptoms and
developmental milestones. During
follow-up, infants will also have cranial
ultrasounds, their head circumference
measured, and hearing and vision tests.
For mothers and their infants, relevant
information collected as part of clinical
care will be abstracted from medical
records. Study results will be used to
guide recommendations made by both
INS and CDC to prevent ZIKV infection;
to improve counseling of patients about
risks to themselves, their pregnancies,
their partners, and their infants; and to
help agencies prepare to provide
services to affected children and
families. Participation in this study is
voluntary. The estimated number of
annual Burden Hours are 20,548 and
there are no costs to participants other
than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Respondents
Form name
Pregnant women .............................................
Pregnant women eligibility questionnaire ......
Pregnant women enrollment questionnaire ...
Adult symptom questionnaire .........................
Pregnant women follow-up questionnaire ......
Infant symptoms questionnaire ......................
Infant Ages and Stages Questionnaire: 2
Month.
Infant Ages and Stages Questionnaire: 6
Month.
Male partner eligibility questionnaire .............
Male enrollment questionnaire .......................
Adult symptom questionnaire .........................
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Male partners ..................................................
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2017–12059 Filed 6–9–17; 8:45 am]
[30Day–17–17BZ]
BILLING CODE 4163–18–P
Centers for Disease Control and
Prevention
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) has submitted the
VerDate Sep<11>2014
17:28 Jun 09, 2017
Jkt 241001
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Average
burden
per response
(in hours)
3,125
2,500
2,500
2,500
2,250
2,250
1
1
15
8
14
1
5/60
35/60
10/60
15/60
10/60
15/60
2,250
1
15/60
2,500
625
625
1
1
7
5/60
25/60
10/60
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
E:\FR\FM\12JNN1.SGM
12JNN1
26932
Federal Register / Vol. 82, No. 111 / Monday, June 12, 2017 / Notices
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
Project PrIDE (PrEP Implementation,
Data to Care & Evaluation)—New—
National Center for HIV/AIDS, Viral
Hepatitis, STD, and TB Prevention
(NCHHSTP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Approximately 50,000 people in the
United States are newly infected with
HIV each year. Gay, bisexual, and other
men who have sex with men (MSM)
remain the US population most heavily
affected by HIV infection. Among MSM,
those who are black and Hispanic
comprise 58% of all new infections. To
address the burden of HIV in this
population, high impact HIV prevention
approaches should be implemented by
state, local, and territorial health
departments to reduce new HIV
infections among MSM of color, and to
improve outcomes along the HIV
continuum of care for MSM of color
living with HIV.
Antiretroviral (ARV) medications for
pre-exposure prophylaxis (PrEP) can be
used for HIV prevention by MSM at
substantial risk for HIV acquisition or by
those with a possible HIV exposure in
the past 72 hours post-exposure
prophylaxis (nPEP). The daily use of coformulated tenofovir disoproxil
fumarate and emtricitabine (marketed as
Truvada) for PrEP has been proven to
significantly reduce the risk of HIV
acquisition among sexually active MSM.
In July 2012, the US Food and Drug
Administration approved an HIV
prevention indication for Truvada, and
in May 2014 CDC published clinical
practice guidelines for provision of
PrEP. Given the high incidence of HIV
among MSM of color, those who are
sexually active are considered at risk for
HIV acquisition and thus could benefit
from prevention services such as routine
and frequent HIV screening with labbased 4th generation HIV tests, routine
screening for STDs, assessment of PrEP
eligibility, provision of PrEP (if at
substantial risk for HIV acquisition),
provision of nPEP (if a possible HIV
exposure occurred in the past 72 hours),
and/or other risk reduction
interventions.
Among people living with HIV
(PLWH), ARV treatment can suppress
HIV viral load, which both improves
health outcomes of individuals and
reduces the risk of HIV transmission.
Two studies, one that demonstrated the
effectiveness of ARV treatment in
preventing HIV transmission, and one
that demonstrated improved health
outcomes for individuals whose ARV
treatment was initiated immediately,
have led to increased public health
focus on interventions and strategies
designed to initiate ARV treatment, link,
retain, and re-engage PLWH in HIV care,
and to provide support for adherence to
ARV medications.
The purpose of the project is to
implement PrEP demonstration projects.
Health departments that are funded
under this cooperative agreement will
be required to prioritize their services to
MSM and transgender persons at high
risk of HIV infection, particularly
persons of color. PrEP services may also
be provided to HIV-negative persons at
substantial risk for HIV who are not
MSM or transgender. Additionally, Data
to Care services may be provided to
persons diagnosed with HIV infection
and out of care, those who are in care
but not virally suppressed, or those who
have ongoing risk behavior who are not
MSM or transgender.
The goals of PrIDE are consistent with
the long-term goals of the National HIV/
AIDS Strategy (NHAS) including
reducing HIV incidence, increasing
access to HIV care and optimizing
health outcomes, and reducing HIVrelated health disparities.
To evaluate the impact of PrIDE in the
12 jurisdictions, data will be collected
from both existing CDC data sources and
through new data collection activities.
CDC HIV program grantees will
collect, enter or upload, and report
agency-identifying information, budget
data, information on the HIV prevention
and care services, and client
demographic characteristics. The total
annual burden hours are 1,104.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Clients .............................................................
Health Departments ........................................
Health Departments ........................................
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Type of respondents
Data Elements ................................................
Data Management Upload .............................
Performance Progress Report .......................
VerDate Sep<11>2014
17:28 Jun 09, 2017
Jkt 241001
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
E:\FR\FM\12JNN1.SGM
2,400
12
12
12JNN1
Number of
responses per
respondent
1
2
1
Average
burden per
response
(in hours)
25/60
20/60
8
Federal Register / Vol. 82, No. 111 / Monday, June 12, 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. 2017–12060 Filed 6–9–17; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Healthcare Infection Control Practices
Advisory Committee (HICPAC)
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC), National
Center for Emerging and Zoonotic
Infectious Diseases (NCEZID) announces
a meeting of the aforementioned
committee:
Times and Dates:
9:00 a.m.–5:00 p.m., EDT, July 13, 2017
9:00 a.m.–12:00 p.m., EDT, July 14, 2017
Place: Centers for Disease Control and
Prevention, Global Communications
Center, Building 19, Auditorium B, 1600
Clifton Road NE., Atlanta, Georgia,
30329.
Status: Open to the public, limited
only by the space available. Time will
be available for public comment. The
public is welcome to submit written
comments in advance of the meeting.
Comments should be submitted in
writing by email to the contact person
listed below. The deadline for receipt is
June 30, 2017. All requests must contain
the name, address, and organizational
affiliation of the speaker, as well as the
topic being addressed. Written
comments should not exceed one singlespaced typed page in length and
delivered in 3 minutes or less. Members
of the public who wish to provide
public comments should plan to attend
the public comment session at the start
time listed. Please note that the public
comment period may end before the
time indicated on the agenda, following
the last call for comments. Written
comments received in advance of the
meeting will be included in the official
record of the meeting.
Purpose: The Committee is charged
with providing advice and guidance to
the Director, Division of Healthcare
Quality Promotion (DHQP), the Director,
National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID),
the Director, CDC, the Secretary, Health
and Human Services regarding (1) the
practice of healthcare infection
VerDate Sep<11>2014
17:28 Jun 09, 2017
Jkt 241001
prevention and control; (2) strategies for
surveillance, prevention, and control of
infections, antimicrobial resistance, and
related events in settings where
healthcare is provided; and (3) periodic
updating of CDC guidelines and other
policy statements regarding prevention
of healthcare-associated infections and
healthcare-related conditions.
Matters for Discussion: The agenda
will include updates on CDC’s activities
for prevention of healthcare associated
infections (HAIs), an update on the
Division of Healthcare Quality
Promotion’s (DHQP) modeling
activities, updates on the Guideline for
Prevention of Infection in Neonatal
Intensive Care Unit (NICU) Patients and
the Guideline for Prevention of Infection
in Healthcare Personnel, and updates
from the following HICPAC workgroups:
The workgroup on antibiotic
stewardship principles for inclusion
into clinical practice guidelines, the
workgroup on updating the CDC
recommendation categorization scheme,
the workgroup on developing CDC
recommendations for products and
practices, and the National Healthcare
Safety Network (NHSN) Surveillance
Workgroup.
Agenda items are subject to change as
priorities dictate.
Contact Person for More Information:
Erin Stone, M.A., HICPAC, Division of
Healthcare Quality Promotion, NCEZID,
CDC, l600 Clifton Road NE., Mailstop
A–07, Atlanta, Georgia 30329,
Telephone (404) 639–4045. Email:
hicpac@cdc.gov.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2017–12122 Filed 6–9–17; 8:45 am]
BILLING CODE 4163–18–P
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
26933
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Secondary
Review
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces a meeting for the secondary
review of applications in response to
Funding Opportunity Announcements
(FOAs), CE17–003, Research Grants for
Preventing Violence and Violence
Related Injury (R01); and PHS 2016–02
Omnibus Solicitation of the NIH, CDC
FDA, and ACF for Small Business
Innovation Research Grant Applications
(Parent SBIR [R43/R44]).
Time and Date: 8:00 a.m.–5:00 p.m.,
EDT, July 18, 2017 (Closed).
Place: Teleconference.
Status: The meeting will be closed to
the public in accordance with
provisions set forth in Section
552b(c)(4) and (6), Title 5 U.S.C., and
the Determination of the Director,
Management Analysis and Services
Office, CDC, pursuant to Public Law 92–
463.
Matters for Discussion: The meeting
will include the secondary review,
discussion, and evaluation of
applications received in response to
FOAs ‘‘Research Grants for Preventing
Violence and Violence Related Injury
(R01)’’, CE17–003; and ‘‘PHS 2016–02
Omnibus Solicitation of the NIH, CDC
FDA, and ACF for Small Business
Innovation Research Grant Applications
(Parent SBIR [R43/R44])’’.
Contact Person for More Information:
Gwendolyn H. Cattledge, Ph.D.,
M.S.E.H., Deputy Associate Director for
Science, National Center for Injury
Prevention and Control, CDC, 4770
Buford Highway NE., Mailstop F–63,
Atlanta, Georgia 30341, Telephone (770)
488–1430.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
E:\FR\FM\12JNN1.SGM
12JNN1
]]>Agencies
[Federal Register Volume 82, Number 111 (Monday, June 12, 2017)]
[Notices]
[Pages 26931-26933]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12060]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-17-17BZ]
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
[[Page 26932]]
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
Project PrIDE (PrEP Implementation, Data to Care & Evaluation)--
New--National Center for HIV/AIDS, Viral Hepatitis, STD, and TB
Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Approximately 50,000 people in the United States are newly infected
with HIV each year. Gay, bisexual, and other men who have sex with men
(MSM) remain the US population most heavily affected by HIV infection.
Among MSM, those who are black and Hispanic comprise 58% of all new
infections. To address the burden of HIV in this population, high
impact HIV prevention approaches should be implemented by state, local,
and territorial health departments to reduce new HIV infections among
MSM of color, and to improve outcomes along the HIV continuum of care
for MSM of color living with HIV.
Antiretroviral (ARV) medications for pre-exposure prophylaxis
(PrEP) can be used for HIV prevention by MSM at substantial risk for
HIV acquisition or by those with a possible HIV exposure in the past 72
hours post-exposure prophylaxis (nPEP). The daily use of co-formulated
tenofovir disoproxil fumarate and emtricitabine (marketed as Truvada)
for PrEP has been proven to significantly reduce the risk of HIV
acquisition among sexually active MSM. In July 2012, the US Food and
Drug Administration approved an HIV prevention indication for Truvada,
and in May 2014 CDC published clinical practice guidelines for
provision of PrEP. Given the high incidence of HIV among MSM of color,
those who are sexually active are considered at risk for HIV
acquisition and thus could benefit from prevention services such as
routine and frequent HIV screening with lab-based 4th generation HIV
tests, routine screening for STDs, assessment of PrEP eligibility,
provision of PrEP (if at substantial risk for HIV acquisition),
provision of nPEP (if a possible HIV exposure occurred in the past 72
hours), and/or other risk reduction interventions.
Among people living with HIV (PLWH), ARV treatment can suppress HIV
viral load, which both improves health outcomes of individuals and
reduces the risk of HIV transmission. Two studies, one that
demonstrated the effectiveness of ARV treatment in preventing HIV
transmission, and one that demonstrated improved health outcomes for
individuals whose ARV treatment was initiated immediately, have led to
increased public health focus on interventions and strategies designed
to initiate ARV treatment, link, retain, and re-engage PLWH in HIV
care, and to provide support for adherence to ARV medications.
The purpose of the project is to implement PrEP demonstration
projects. Health departments that are funded under this cooperative
agreement will be required to prioritize their services to MSM and
transgender persons at high risk of HIV infection, particularly persons
of color. PrEP services may also be provided to HIV-negative persons at
substantial risk for HIV who are not MSM or transgender. Additionally,
Data to Care services may be provided to persons diagnosed with HIV
infection and out of care, those who are in care but not virally
suppressed, or those who have ongoing risk behavior who are not MSM or
transgender.
The goals of PrIDE are consistent with the long-term goals of the
National HIV/AIDS Strategy (NHAS) including reducing HIV incidence,
increasing access to HIV care and optimizing health outcomes, and
reducing HIV-related health disparities.
To evaluate the impact of PrIDE in the 12 jurisdictions, data will
be collected from both existing CDC data sources and through new data
collection activities.
CDC HIV program grantees will collect, enter or upload, and report
agency-identifying information, budget data, information on the HIV
prevention and care services, and client demographic characteristics.
The total annual burden hours are 1,104.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Clients............................... Data Elements........... 2,400 1 25/60
Health Departments.................... Data Management Upload.. 12 2 20/60
Health Departments.................... Performance Progress 12 1 8
Report.
----------------------------------------------------------------------------------------------------------------
[[Page 26933]]
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. 2017-12060 Filed 6-9-17; 8:45 am]
BILLING CODE 4163-18-P
