60d FRN - published

24478

Federal Register / Vol. 83, No. 103 / Tuesday, May 29, 2018 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Total burden
(in hours)

Form name

International panel physicians ..........

TB Indicators Excel Spreadsheet ....

336

1

3

1,008

Total ...........................................

...........................................................

........................

........................

........................

1,008

Jeffery M. Zirger,
Acting Chief, Information Collection Review
Office, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
[FR Doc. 2018–11401 Filed 5–25–18; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

[60Day–18–18AAE; Docket No. CDC–2018–
0039]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

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 project
titled National HIV Behavioral
Surveillance among Transgender
women (NHBS-Trans). CDC is
requesting a new 2-year approval to
pilot collecting standardized HIVrelated behavioral data from transgender
women at risk for HIV systematically
selected from 9 Metropolitan Statistical
Areas (MSAs) throughout the United
States.

SUMMARY:

CDC must receive written
comments on or before July 30, 2018.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2018–
0039 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
DATES:

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16:39 May 25, 2018

Jkt 244001

• 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.

Centers for Disease Control and
Prevention

daltland on DSKBBV9HB2PROD with NOTICES

Average
burden per
response
(in hours)

Number of
responses per
respondent

Number of
respondents

Type of respondents

To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Leroy A.
Richardson, Information Collection
Review Office, Centers for Disease
Control and Prevention, 1600 Clifton
Road NE, MS–D74, Atlanta, Georgia
30329; phone: 404–639–7570; Email:
[email protected].
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,
FOR FURTHER INFORMATION CONTACT:

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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
National HIV Behavioral Surveillance
System—among Transgender women
(NHBS-Trans)—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 purpose of this data collection is
to monitor behaviors related to Human
Immunodeficiency Virus (HIV)
transmission and prevention in the
United States of transgender women,
who are known to be at high risk for
HIV infection, and to assess barriers to,
and best strategies for, conducting biobehavioral surveys among minority
transgender women in nine cities. This
includes recruiting, interviewing and
providing HIV testing and referral to
services (as needed) following CDC
protocol based on an existing HIV
Behavioral Surveillance system. The
proposed respondents are 200 adult
minority trangender women in each of
nine cities (1,800 interviews total) who
will each respond one time over the
course of the two year pilot. The
information will be collected over a two
year period beginning no later than two
months after OMB approval.
NHBS-Trans provides information to
help prevent HIV among transgender
women. Preventing HIV, especially
among high-risk groups, is an effective
strategy for reducing individual, local,
and national healthcare costs. The
utility of this information is to provide
CDC and local health department staff
with data for evaluating progress
towards local and national public health

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24479

Federal Register / Vol. 83, No. 103 / Tuesday, May 29, 2018 / Notices
goals, such as reducing new HIV
infections, increasing the use of
condoms, and targeting high risk groups
by describing and monitoring the HIV
risk behaviors, HIV seroprevalence and
incidence, and HIV prevention
experiences of persons at highest risk
for HIV infection.
The Centers for Disease Control and
Prevention request two year approval
for a new information collection. Data
will be collected through anonymous,
in-person interviews conducted with
persons systematically selected from
nine Metropolitan Statistical Areas
(MSAs) throughout the United States;
these nine MSAs were chosen based on
having high HIV prevalence. A brief
screening interview will be used to
determine eligibility for participation in
the behavioral assessment. Participants
will be recruited through respondentdriven sampling, a scientifically proven
recruitment strategy for reaching
hidden, hard-to-reach, or stigmatized
populations. Interview data will be
recorded on secure portable computers,
without internet connections. Data will

behavior related to the risk of HIV and
other sexually transmitted diseases, (2)
prior testing for HIV, (3) and use of HIV
prevention services. All persons
interviewed will also be offered an HIV
test, and will participate in a pre-test
counseling session. No other federal
agency systematically collects this type
of information from persons at risk for
HIV infection. These data have
substantial impact on prevention
program development and monitoring at
the local, state, and national levels.
The Burden Table below shows the
estimated annualized burden hours for
the participants’ time. Annually, 990
participants will complete an eligibility
screener (an average of 5 minutes to
complete), 900 participants will
complete the Behavioral Assessment (an
average of 40 minutes to complete), and
900 will complete the Recruiter
Debriefing Form (an average of two
minutes to complete). The estimated
total annualized burden would be 713
hours. Participation of respondents is
voluntary. There are no costs to
respondents other than their time.

be transferred to secure, encrypted data
servers. Data will be stored at CDC and
shared with local health departments in
accordance with existing data use
agreements and the Assurance of
Confidentiality for HIV/AIDS
Surveillance Data. Data will be
disseminated in aggregate through
academic and agency publications,
presentations, and reports. All data
collection and activities will be
anonymous.
Personally identifiable information
(PII) is not included in the data
collection. The CDC Privacy Officer has
assessed this package for applicability of
5 U.S.C. 552a. The Privacy Act is not
applicable because PII is not being
collected under this CDC funded
activity. The NHBS-Trans formative
interview and optional HIV testing are
anonymous (neither names nor Social
Security numbers are collected). Data
that will be collected through NHBSTrans, while sensitive, are not
personally identifying.
The data from the behavioral
assessment will provide estimates of (1)

ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)

Number of
responses per
respondent

Total
burden
(in hours)

Form name

Persons Screened .............................
Eligible Participant .............................
Peer Recruiters .................................

Eligibility Screener ...........................
Behavioral Assessment ...................
Recruiter Debriefing .........................

990
900
900

1
1
1

5/60
40/60
2/60

83
600
30

Total ...........................................

..........................................................

........................

........................

........................

713

Jeffrey M. Zirger,
Acting Chief, Information Collection Review
Office, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
[FR Doc. 2018–11399 Filed 5–25–18; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–1468]

daltland on DSKBBV9HB2PROD with NOTICES

Number of
respondents

Type of respondents

Registration of Food Facilities: What
You Need To Know About the Food
and Drug Administration Regulation;
Small Entity Compliance Guide;
Availability
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notification of availability.

VerDate Sep<11>2014

16:39 May 25, 2018

Jkt 244001

The Food and Drug
Administration (FDA or we) is
announcing the availability of a final
guidance for industry entitled
‘‘Registration of Food Facilities: What
You Need To Know About the FDA
Regulation—Small Entity Compliance
Guide.’’ The small entity compliance
guide (SECG) is intended to help small
entities comply with a final rule we
issued in the Federal Register of July
14, 2016, entitled ‘‘Amendments to
Registration of Food Facilities.’’ The
final rule amends the registration of
food facilities regulations.
DATES: The announcement of the
guidance is published in the Federal
Register on May 29, 2018.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:

Electronic Submissions
Submit electronic comments in the
following way:

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• 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
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

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