Agency Forms Undergoing Paperwork Reduction Act Review

 
CONTENT
32918
Federal Register / Vol. 84, No. 132 / Wednesday, July 10, 2019 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–19–19BG]
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 ‘‘Web-based
approaches to reach black or African
American and Hispanic/Latino MSM for
HIV Testing and Prevention Services’’ 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 December 6, 2018 to obtain
comments from the public and affected
agencies. CDC received one substantive
comment 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:
(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
Web-based approaches to reach black
or African American and Hispanic/
Latino MSM for HIV Testing and
Prevention Services—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 goal of this study is to evaluate
the effectiveness of mailing out rapid
HIV home-testing kits and additional
testing promotion components to
increase HIV testing among black/
African-American or Hispanic/Latino
MSM. The findings from this research
will assist local and state health
departments, and community based
organizations in making decisions on
how to improve HIV testing and linkage
to HIV prevention services for black/
African American and Hispanic/Latino
men who have sex with men.
The research study is a randomized
control trial and all survey data will be
collected over the internet. There will
not be any in-person surveys. We will
advertise the study on internet websites
frequented by black and Hispanic MSM.
People will click on a banner ad and
will be taken to a study website that
provides a brief overview of the study.
Those who are interested in
participating will complete a brief
survey to determine their eligibility.
Men who are eligible will complete
registration information and then
download a study phone app onto their
smartphone. The app will allow them to
complete a baseline survey. After
completing the baseline survey, they
will be randomized into one of three
conditions.
All participants will be sent up to four
rapid HIV test kits for their use and to
give to their friends (hereafter referred
to as ‘‘guests’’) and they will report their
results to the study. Participants will
use the study app to complete study
activities. All participants and guests
will have access to web-based HIV
counseling upon request. Participants
who report a positive HIV test result
will be offered web-based HIV
counseling if they have not previously
requested counseling. Men assigned to
the control arm will only have access to
the study app and web-based
counseling. Men assigned to one
intervention arm will also be able to
access another smartphone app
(HealthMindr) that will allow them to
engage in additional study activities.
Men assigned to the second intervention
arm will have access to a web-based
forum (HealthEmpowerment) covering
HIV prevention and not the
HealthMindr app. At four months after
enrollment, all participants will
complete an online survey and will be
offered additional HIV testing materials
to complete. Guests who receive a study
HIV self-test kit will be able to report
the result online.
The subpopulation are individuals
who: (1) Identify as African-American/
black or Hispanic/Latino; (2) report their
HIV status as negative or report being
unaware of their HIV status; (3) are not
currently using PrEP or participating in
other HIV testing prevention studies; (4)
have had anal intercourse with another
man in the past 12 months; (5) reside in
one of the study states and not planning
to move out of the state in the next 4
months; (6) Are 18 years or older; (7)
born male; and (8) identify as male. We
will evaluate the comparative
effectiveness of the HIV home-testing
kits and additional testing promotion
components with respect to linkage of
participants to appropriate services (HIV
treatment, PrEP, STI testing, additional
prevention and social services). These
analyses will determine whether any
such differences are significant within
and across study arms, and by race/
ethnicity.
Depending on the study arm to which
participants are assigned filling out data
collection forms, engaging with testing
promotion components, and completing
and submitting at-home HIV testing this
will require between two hours 25
minutes and three hours and 45 minutes
of a participant’s time over the course of
the entire study period. Guests who
receive an HIV self-test from a study
participant will take up to 37 minutes
to complete the testing activities.
The total annual burden hours are
1,517. There are no other costs to
respondents other than time.
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32919
Federal Register / Vol. 84, No. 132 / Wednesday, July 10, 2019 / Notices
E
STIMATED
A
NNUALIZED
B
URDEN
H
OURS
Type of respondent Form name Number of
respondents
Number of
responses per
respondent
per year
Average
burden per
response
(in hrs)
Potential participant ........................................ Eligibility Consent ........................................... 3,333 3 2/60
Potential participant ........................................ Eligibility Screener .......................................... 3,333 20 2/60
Potential participant ........................................ Study Consent ................................................ 1,333 2 4/60
Potential participant ........................................ Registration contact information .................... 1,267 7 2/60
Enrolled participant ......................................... Baseline Survey ............................................. 1,200 107 20/60
Enrolled participant ......................................... Initial HIV Test Result Survey ........................ 1,000 43 5/60
Enrolled participant ......................................... Follow-up Survey ........................................... 1,000 187 30/60
Enrolled participant ......................................... Final HIV Test Result Survey ........................ 1,000 18 5/60
Enrolled participant ......................................... Product ordering ............................................. 400 12 3/60
Guest ............................................................... Guest Consent ............................................... 667 1 2/60
Guest ............................................................... Guest HIV Test Result Survey ....................... 667 24 5/60
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–14681 Filed 7–9–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–19–1129; Docket No. CDC–2019–
0058]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
AGENCY
: Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION
: Notice with comment period.
SUMMARY
: The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies the opportunity to comment on
a proposed and/or continuing
information collection, as required by
the Paperwork Reduction Act of 1995.
This notice invites comment on a
proposed information collection titled,
Improving Fetal Alcohol Spectrum
Disorders (FASD) Prevention and
Practice through Practice and
Implementation Centers and National
Partnerships (PICs). The purpose of
FASD PICs is to collect training
evaluation data from healthcare
practitioners and staff in health systems
where FASD-related practice and
systems changes are implemented, and
from grantees of Practice and
Implementation Centers and national
partner organizations related to
prevention, identification, and
treatment of fetal alcohol spectrum
disorders (FASDs).
DATES
: CDC must receive written
comments on or before September 9,
2019.
ADDRESSES
: You may submit comments,
identified by Docket No. CDC–2019–
0058 by any of the following methods:
Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
Mail: Jeffrey M. Zirger, Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, MS–D74, Atlanta,
Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to
Regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(regulations.gov) or by U.S. mail to the
address listed above.
FOR FURTHER INFORMATION CONTACT
: To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Jeffrey M. Zirger,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS–
D74, Atlanta, Georgia 30329; phone:
404–639–7570; Email: omb@cdc.gov.
SUPPLEMENTARY INFORMATION
: 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. In addition, the PRA also
requires Federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to the OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
The OMB is particularly interested in
comments that will help:
1. 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;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected; and
4. 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 submissions
of responses.
5. Assess information collection costs
Proposed Project
Improving Fetal Alcohol Spectrum
Disorders (FASD) Prevention and
Practice through Practice and
Implementation Centers and National
Partnerships’’ project (OMB Control No.
0920–1129, Exp. 8/31/2019))—Revision
— National Center for Birth Defects and
Developmental Disability (NCBDDD),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Prenatal exposure to alcohol is a
leading preventable cause of birth
defects and developmental disabilities.
The term ‘fetal alcohol spectrum
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