Agency Forms Undergoing Paperwork Reduction Act Review, 5682-5684 [2019-03099]
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5682
Federal Register / Vol. 84, No. 36 / Friday, February 22, 2019 / Notices
individuals (e.g., parents and
physicians) and representatives of
professional medical and communitybased organizations. A summary of
public comments and responses to
comments, including changes are noted
in the Summary of Public Comments
and CDC Responses to Public Comments
for Information for Providers Counseling
Male Patients and Parents Regarding
Male Circumcision and the Prevention
of HIV infection, Sexually Transmitted
Infections, and other Health Outcomes.
This document is in the docket at:
www.regulations.gov and at https://
www.cdc.gov/hiv/pdf/risk/MC-HISAPublic-Comments-and-Responses.pdf.
Peer Review comments (initial
comment period). Peer reviewers were
asked to review the Initial Draft
Document and its companion
document, Background, Methods, and
Synthesis of Scientific Information Used
to Inform the ‘Recommendations for
Providers Counseling Male Patients and
Parents Regarding Male Circumcision
and the Prevention of HIV infection,
STIs, and other Health Outcomes.’ On
August 30, 2018, the title of this
companion document was changed to
Background, Methods, and Synthesis of
Scientific Information Used to Inform
‘Information for Providers to Share with
Male Patients and Parents Regarding
Male Circumcision and the Prevention
of HIV Infection, Sexually Transmitted
Infections, and other Health Outcomes’
to better align with the content in the
final document.
CDC considers these documents to be
highly influential scientific assessments
(HISA) as defined by the Office of
Management and Budget’s (OMB)
directive, Final Information Quality
Bulletin for Peer Review, dated
December 15, 2004. HISA documents
are subject to peer review.
Peer reviewers evaluated the
appropriateness of the methods and of
the interpretation of findings, including
generalizability of the evidence to the
United States. Peer review comments
were received from three physician peer
reviewers. A copy of peer review
comments, CDC responses, and changes
are noted in the documents titled: Peer
Review Comments and CDC Responses
for Peer Review Comments and CDC
Responses for ‘‘Information for
Providers to Share with Male Patients
and Parents Regarding Male
Circumcision and the Prevention of HIV
infection, Sexually Transmitted
Infections, and other Health Outcomes’’
and ‘‘Background, Methods, and
Synthesis of Scientific Information Used
to Inform ‘Information for Providers to
Share with Male Patients and Parents
Regarding Male Circumcision and the
VerDate Sep<11>2014
16:52 Feb 21, 2019
Jkt 247001
Prevention of HIV Infection, Sexually
Transmitted Infections, and other
Health Outcomes.’ These documents are
in the public docket at
www.regulations.gov and at https://
www.cdc.gov/hiv/pdf/risk/MC-HISARound-1-Peer-Review-Comments-andResponses.pdf.
Second comment period. The second
comment period was opened during
September 15–30, 2016, for peer review
only.
Peer Review comments (second
comment period). Peer Reviewers
reviewed and commented on a revised
copy of the Initial Draft Document. Peer
Reviewers were asked to limit their
comments only to changes that were
made as a result of the initial comment
period.
Comments were received from two
peer reviewers. A summary of peer
review comments, CDC responses, and
changes made are noted in the Summary
of Peer Review Comments and CDC
Responses to Second Round of Peer
Review Comments for Information for
Providers to Share with Male Patients
and Parents Regarding Male
Circumcision and the Prevention of HIV
Infection, Sexually Transmitted
Infections, and other Health Outcomes
are in the public docket at
www.regulations.gov and at https://
www.cdc.gov/hiv/pdf/risk/MC-HISARound-2-Peer-Review-Comments-andResponses.pdf.
All comments were carefully
reviewed and considered in the
development of the final version of the
document found in the public docket at
www.regulations.gov and at https://
www.cdc.gov/hiv/risk/malecircumcision.html.
Dated: February 14, 2019.
Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2019–02907 Filed 2–21–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Board of Scientific Counselors,
National Institute for Occupational
Safety and Health: Notice of Charter
Renewal
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of charter renewal.
AGENCY:
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This gives notice under the
Federal Advisory Committee Act of
October 6, 1972, that the Board of
Scientific Counselors, National Institute
for Occupational Safety and Health,
Centers for Disease Control and
Prevention, Department of Health and
Human Services, has been renewed for
a 2-year period through February 3,
2021.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Alberto Garcia, M.S., Executive
Secretary, BSC, NIOSH, CDC, 555 Ridge
Avenue, MS–R5, Cincinnati, OH 45213,
telephone (513) 841–4596, fax (513)
841–4506.
The Chief Operating Officer, Centers
for Disease Control and Prevention, 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.
Sherri Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2019–03008 Filed 2–21–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–18–18AQQ]
Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled ‘‘HIV
prevention among Latina transgender
women: Evaluation of a Locally
Developed Intervention (ChiCAS)’’ to
the Office of Management and Budget
(OMB) for review and approval. CDC
previously published a ‘‘Proposed Data
Collection Submitted for Public
Comment and Recommendations’’
notice on August 23, 2018 to obtain
comments from the public and affected
agencies. CDC did not receive comments
related to the previous notice. This
notice serves to allow an additional 30
days for public and affected agency
comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
E:\FR\FM\22FEN1.SGM
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5683
Federal Register / Vol. 84, No. 36 / Friday, February 22, 2019 / Notices
(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. Direct
written comments and/or suggestions
regarding the items contained in this
notice to the Attention: CDC Desk
Officer, Office of Management and
Budget, 725 17th Street NW,
Washington, DC 20503 or by fax to (202)
395–5806. Provide written comments
within 30 days of notice publication.
Proposed Project
HIV prevention among Latina
Transgender Women: Evaluation of a
Locally Developed Intervention
(ChiCAS)’’—New—National Center for
HIV/AIDS, Viral Hepatitis, STD, and TB
Prevention (NCHHSTP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
The National Center for HIV/AIDS,
Viral Hepatitis, STD and TB Prevention
is requesting approval for 20-months of
data collection entitled, ‘‘HIV
prevention among Latina transgender
women: Evaluation of a locally
developed intervention.’’ The goal of
this study is to evaluate the efficacy of
ChiCAS (Chicas Creando Acceso a la
Salud [Chicas: Girls Creating Access to
Health]), a locally developed and
culturally congruent two-session
Spanish-language small-group
combination intervention designed to
promote consistent condom use, and
access to and participation in preexposure prophylaxis (PrEP) and
medically supervised hormone therapy
by HIV seronegative Hispanic/Latina
transgender women who have sex with
men.
The information collected through
this study will be used to evaluate
whether the ChiCAS intervention is an
effective HIV-prevention strategy by
assessing whether exposure to the
intervention results in improvements in
participants’ health and HIV prevention
behaviors. The study will compare pre(baseline) and post-intervention (6month) levels of HIV risk among
participants who have received the
intervention and participants who have
not yet received the intervention
(delayed-intervention group).
This study will be carried out in five
metropolitan areas in North Carolina:
Ashville, NC; Charlotte, NC; Research
Triangle (metropolitan area of
Greensboro, Winston-Salem and High
Point NC); Raleigh, NC; and
Wilmington, NC. The study population
will include 140 HIV-negative Spanishspeaking transgender women.
Participants will be adults, at least 18
years of age, self-identify as male-tofemale transgender or report having
been born male and identifying as
female, and report having sex with at
least one man in the past six months.
We anticipate participants will be
comprised mainly of racial/ethnic
minority participants under 35 years of
age, consistent with the epidemiology of
HIV infection among transgender
women.
Intervention participants will be
recruited to the study through a
combination of approaches, including
traditional print advertisement, referral,
in-person outreach, and through word of
mouth. A quantitative assessment will
be used to collect information for this
study, which will be delivered at the
time of study enrollment and again at 6month follow up. The assessment will
be used to measure differences in sexual
risk knowledge, perceptions and
behaviors including condom use, PrEP
use and use of medically supervised
hormone therapy. Intervention
mediators, including healthcare
provider trust and communication
skills, self-reported health status and
healthcare access, community
attachment and social support will also
be measured. All participants will
complete the assessment at baseline and
again at 6-month follow-up after
enrolling in the study. The intervention
group will participate in ChiCAS after
completing the baseline assessment and
the delayed intervention group will
participate in ChiCAS after completing
the 6-month follow up assessment.
We will also examine intervention
experiences through in-depth interviews
with 30 intervention group participants.
The interviews will capture
participants’ general experiences with
the ChiCAS intervention, as well as
their experiences and perceptions
specific to the main study outcomes:
PrEP knowledge, awareness, interest
and use; condom skills and use; and
hormone therapy knowledge,
awareness, interest and use.
It is expected that 50% of transgender
women screened will meet study
eligibility. We expect the initial
screening to take approximately four
minutes to complete. The assessment
will take 60 minutes (one hour) to
complete and will be administered to
140 participants a total of two times.
The interview will take 90 minutes (one
and one-half hours) to complete and
will be administered to 30 participants
from the intervention group one time.
There are no costs to the respondents
other than their time. The total number
of burden hours is 344 across 23-months
of data collection. The total estimated
annualized burden hours is 172.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents
General
General
General
General
Public—Adults
Public—Adults
Public—Adults
Public—Adults
VerDate Sep<11>2014
...................................
...................................
...................................
...................................
16:52 Feb 21, 2019
Jkt 247001
Number of
respondents
Form name
Eligibility Screener ..........................................
Contact Information ........................................
Assessment ....................................................
Interview .........................................................
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E:\FR\FM\22FEN1.SGM
140
70
70
15
22FEN1
Number of
responses per
respondent
1
1
2
1
Average
burden per
response
(in hours)
3/60
1/60
60/60
90/60
5684
Federal Register / Vol. 84, No. 36 / Friday, February 22, 2019 / Notices
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–03099 Filed 2–21–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Clinical Laboratory Improvement
Advisory Committee (CLIAC)
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:
In accordance with the
Federal Advisory Committee Act, the
CDC announces the following meeting
for the Clinical Laboratory Improvement
Advisory Committee (CLIAC). This
meeting is open to the public, limited
only by the space available. The meeting
room accommodates approximately 100
people. The public is also welcome to
view the meeting by webcast. Check the
CLIAC website on the day of the
meeting for the webcast link
www.cdc.gov/cliac.
DATES: The meeting will be held on
April 10, 2019, 8:30 a.m. to 6:00 p.m.,
EDT and April 11, 2019, 8:30 a.m. to
1:00 p.m., EDT.
ADDRESSES: The Centers for Medicare &
Medicaid Services, 7500 Security
Boulevard, Baltimore, Maryland 21244
and via webcast at www.cdc.gov/cliac.
FOR FURTHER INFORMATION CONTACT:
Nancy Anderson, MMSc, MT(ASCP),
Senior Advisor for Clinical Laboratories,
Division of Laboratory Systems, Center
for Surveillance, Epidemiology and
Laboratory Services, Office of Public
Health Scientific Services, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, Mailstop V24–3,
Atlanta, Georgia 30329–4018, telephone
(404) 498–2741; NAnderson@cdc.gov.
SUPPLEMENTARY INFORMATION:
Purpose: This Committee is charged
with providing scientific and technical
advice and guidance to the Secretary of
Health and Human Services (HHS); the
Assistant Secretary for Health; the
Director, Centers for Disease Control
and Prevention; the Commissioner,
Food and Drug Administration (FDA);
and the Administrator, Centers for
Medicare and Medicaid Services (CMS).
The advice and guidance pertain to
general issues related to improvement in
clinical laboratory quality and
laboratory medicine practice and
SUMMARY:
VerDate Sep<11>2014
16:52 Feb 21, 2019
Jkt 247001
specific questions related to possible
revision of the Clinical Laboratory
Improvement Amendment (CLIA)
standards. Examples include providing
guidance on studies designed to
improve safety, effectiveness, efficiency,
timeliness, equity, and patientcenteredness of laboratory services;
revisions to the standards under which
clinical laboratories are regulated; the
impact of proposed revisions to the
standards on medical and laboratory
practice; and the modification of the
standards and provision of nonregulatory guidelines to accommodate
technological advances, such as new
test methods, the electronic
transmission of laboratory information,
and mechanisms to improve the
integration of public health and clinical
laboratory practices.
All people attending the CLIAC
meeting in-person are required to
register for the meeting online at least
five business days in advance for U.S.
citizens and at least 15 business days in
advance for international registrants.
Register at www.cdc.gov/cliac. Register
by scrolling down and clicking the
‘‘Register for this Meeting’’ button and
completing all forms according to the
instructions given. Please complete all
the required fields before submitting
your registration and submit no later
than April 2, 2019 for U.S. registrants
and March 19, 2019 for international
registrants.
It is the policy of CLIAC to accept
written public comments and provide a
brief period for oral public comments on
agenda items. Public comment periods
for each agenda item are scheduled
immediately prior to the Committee
discussion period for that item. In
general, each individual or group
requesting to make oral comments will
be limited to a total time of five minutes
(unless otherwise indicated). To assure
adequate time is scheduled for public
comments, speakers should notify the
contact person below at least five
business days prior to the meeting date.
For individuals or groups unable to
attend the meeting, CLIAC accepts
written comments until the date of the
meeting (unless otherwise stated).
However, it is requested that comments
be submitted at least five business days
prior to the meeting date so that the
comments may be made available to the
Committee for their consideration and
public distribution. Written comments,
one hard copy with original signature,
should be provided to the contact
person at the mailing or email address
below, and will be included in the
meeting’s Summary Report.
The CLIAC meeting materials will be
made available to the Committee and
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the public in electronic format (PDF) on
the internet instead of by printed copy.
Check the CLIAC website on the day of
the meeting for materials: www.cdc.gov/
cliac.
Matters to be Considered: The agenda
will include agency updates from CDC,
CMS, and FDA. Presentations and
discussions will focus on an update
from the CDC’s Office of Infectious
Diseases Board of Scientific Counselors
meeting and reports from three CLIAC
workgroups: the CLIA Personnel
Regulations Workgroup, the
Nontraditional Testing Workflow Model
Workgroup, and the Next Generation
Sequencing Workgroup. Agenda items
are subject to change as priorities
dictate.
The Chief Operating Officer, Centers
for Disease Control and Prevention, 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.
Sherri Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2019–03009 Filed 2–21–19; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Board of Scientific Counselors,
National Center for Injury Prevention
and Control, NCIPC; Correction
Notice is hereby given of a change in
the meeting of the Board of Scientific
Counselors, National Center for Injury
Prevention and Control; March 14, 2019,
02:00 p.m. to 05:00 p.m. EDT which was
published in the Federal Register on
January 30, 2019 Volume 84, Number
20, page 473.
The meeting is being changed to a
partially open and partially closed
meeting. This meeting will be open to
the public from 02:00 p.m.–02:40 p.m.
to update the public on the Opioid
Prescribing Estimate project. The dial in
number for the open portion of the
meeting is as follows: 1–866–880–0098;
Conference ID: 31769267. The meeting
will be closed to the public from 02:45
p.m.–05:00 p.m.
FOR FURTHER INFORMATION CONTACT:
Gwendolyn H. Cattledge, Ph.D.,
M.S.E.H., Deputy Associate Director for
Science, National Center for Injury
Prevention and Control, CDC, 4770
E:\FR\FM\22FEN1.SGM
22FEN1
]]>Agencies
[Federal Register Volume 84, Number 36 (Friday, February 22, 2019)]
[Notices]
[Pages 5682-5684]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03099]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-18-18AQQ]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled ``HIV prevention among Latina transgender
women: Evaluation of a Locally Developed Intervention (ChiCAS)'' to the
Office of Management and Budget (OMB) for review and approval. CDC
previously published a ``Proposed Data Collection Submitted for Public
Comment and Recommendations'' notice on August 23, 2018 to obtain
comments from the public and affected agencies. CDC did not receive
comments related to the previous notice. This notice serves to allow an
additional 30 days for public and affected agency comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
[[Page 5683]]
(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. Direct written comments
and/or suggestions regarding the items contained in this notice to the
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide
written comments within 30 days of notice publication.
Proposed Project
HIV prevention among Latina Transgender Women: Evaluation of a
Locally Developed Intervention (ChiCAS)''--New--National Center for
HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers
for Disease Control and Prevention (CDC).
Background and Brief Description
The National Center for HIV/AIDS, Viral Hepatitis, STD and TB
Prevention is requesting approval for 20-months of data collection
entitled, ``HIV prevention among Latina transgender women: Evaluation
of a locally developed intervention.'' The goal of this study is to
evaluate the efficacy of ChiCAS (Chicas Creando Acceso a la Salud
[Chicas: Girls Creating Access to Health]), a locally developed and
culturally congruent two-session Spanish-language small-group
combination intervention designed to promote consistent condom use, and
access to and participation in pre-exposure prophylaxis (PrEP) and
medically supervised hormone therapy by HIV seronegative Hispanic/
Latina transgender women who have sex with men.
The information collected through this study will be used to
evaluate whether the ChiCAS intervention is an effective HIV-prevention
strategy by assessing whether exposure to the intervention results in
improvements in participants' health and HIV prevention behaviors. The
study will compare pre- (baseline) and post-intervention (6-month)
levels of HIV risk among participants who have received the
intervention and participants who have not yet received the
intervention (delayed-intervention group).
This study will be carried out in five metropolitan areas in North
Carolina: Ashville, NC; Charlotte, NC; Research Triangle (metropolitan
area of Greensboro, Winston-Salem and High Point NC); Raleigh, NC; and
Wilmington, NC. The study population will include 140 HIV-negative
Spanish-speaking transgender women. Participants will be adults, at
least 18 years of age, self-identify as male-to-female transgender or
report having been born male and identifying as female, and report
having sex with at least one man in the past six months. We anticipate
participants will be comprised mainly of racial/ethnic minority
participants under 35 years of age, consistent with the epidemiology of
HIV infection among transgender women.
Intervention participants will be recruited to the study through a
combination of approaches, including traditional print advertisement,
referral, in-person outreach, and through word of mouth. A quantitative
assessment will be used to collect information for this study, which
will be delivered at the time of study enrollment and again at 6-month
follow up. The assessment will be used to measure differences in sexual
risk knowledge, perceptions and behaviors including condom use, PrEP
use and use of medically supervised hormone therapy. Intervention
mediators, including healthcare provider trust and communication
skills, self-reported health status and healthcare access, community
attachment and social support will also be measured. All participants
will complete the assessment at baseline and again at 6-month follow-up
after enrolling in the study. The intervention group will participate
in ChiCAS after completing the baseline assessment and the delayed
intervention group will participate in ChiCAS after completing the 6-
month follow up assessment.
We will also examine intervention experiences through in-depth
interviews with 30 intervention group participants. The interviews will
capture participants' general experiences with the ChiCAS intervention,
as well as their experiences and perceptions specific to the main study
outcomes: PrEP knowledge, awareness, interest and use; condom skills
and use; and hormone therapy knowledge, awareness, interest and use.
It is expected that 50% of transgender women screened will meet
study eligibility. We expect the initial screening to take
approximately four minutes to complete. The assessment will take 60
minutes (one hour) to complete and will be administered to 140
participants a total of two times. The interview will take 90 minutes
(one and one-half hours) to complete and will be administered to 30
participants from the intervention group one time. There are no costs
to the respondents other than their time. The total number of burden
hours is 344 across 23-months of data collection. The total estimated
annualized burden hours is 172.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
General Public--Adults................ Eligibility Screener.... 140 1 3/60
General Public--Adults................ Contact Information..... 70 1 1/60
General Public--Adults................ Assessment.............. 70 2 60/60
General Public--Adults................ Interview............... 15 1 90/60
----------------------------------------------------------------------------------------------------------------
[[Page 5684]]
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2019-03099 Filed 2-21-19; 8:45 am]
BILLING CODE 4163-18-P
