60 Day FRN

Attachment B 60-day FRN.pdf

Foreign Quarantine Regulations (42CFR71)

60 Day FRN

OMB: 0920-0134

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Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices
members are Special Government
Employees, requiring the filing of
financial disclosure reports at the
beginning of and annually during their
terms. NIOSH identifies potential
candidates and provides a slate of
nominees for consideration to the
Director of CDC for STAC membership
each year; CDC reviews the proposed
slate of candidates, and provides a slate
of nominees for consideration to the
Secretary of HHS for final selection.
HHS notifies selected candidates of
their appointment near the start of the
term in October, or as soon as the HHS
selection process is completed. Note
that the need for different expertise
varies from year to year and a candidate
who is not selected in one year may be
reconsidered in a subsequent year.
Candidates should submit the
following items:
D Current curriculum vitae, including
complete contact information
(telephone numbers, mailing address,
email address);
D The category of membership
(environmental medicine or
environmental health specialist,
occupational physician, pulmonary
physician, representative of WTC
responders, representative of certifiedeligible WTC survivors, industrial
hygienist, toxicologist, epidemiologist,
or mental health professional) that the
candidate is qualified to represent;
D A summary of the background,
experience, and qualifications that
demonstrates the candidate’s suitability
for the nominated membership category;
and
D At least one letter of
recommendation from a person(s) not
employed by HHS. (Candidates may
submit letter(s) from current HHS
employees if they wish, but at least one
letter must be submitted by a person not
employed by an HHS agency (e.g., CDC,
NIH, FDA, etc.).
Nominations may be submitted by the
candidate him- or herself, or by the
person/organization recommending the
candidate.
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 CDC and
the Agency for Toxic Substances and
Disease Registry.
Sherri Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2018–19418 Filed 9–6–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–18–0134; Docket No. CDC–2018–
0078]

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 Foreign Quarantine Regulations,
an information collection related to
illness and death reports from airplanes
and maritime vessels coming to the
United States, illness and death
investigations of travelers, and
information from importers of certain
items specified under 42 CFR 71
subpart F.
DATES: CDC must receive written
comments on or before November 6,
2018.
SUMMARY:

You may submit comments,
identified by Docket No. CDC–2018–
0078 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
ADDRESSES:

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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,
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
Foreign Quarantine Regulations (42
CFR 71) (OMB Control No. 0920–0134)
(Exp 5/31/2019)—Revision—National
Center for Emerging and Zoonotic
Infectious Diseases (NCEZID), Centers
for Disease Control and Prevention
(CDC).
Background and Brief Description
Section 361 of the Public Health
Service Act (PHSA) (42 U.S.C. 264)
(Attachment A1) authorizes the
Secretary of Health and Human Services
to make and enforce regulations
necessary to prevent the introduction,
transmission or spread of communicable
diseases from foreign countries into the
United States. Statute and the existing

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Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices

regulations governing foreign quarantine
activities (42 CFR 71) authorize
quarantine officers and other personnel
to inspect and undertake necessary
control measures with respect to
conveyances, persons, and shipments of
animals and etiologic agents in order to
protect the public’s health. Other
inspection agencies, such as Customs
and Border Protection (CBP), assist
quarantine officers in public health
screening of persons, pets, and other
importations of public health
importance and make referrals to
quarantine station staff when indicated.
These practices and procedures ensure
protection against the introduction and
spread of communicable diseases into
and within the United States with a
minimum of recordkeeping and
reporting procedures, as well as a
minimum of interference with trade and
travel.
U.S. Quarantine Stations are located
at 20 ports of entry and land-border
crossings where international travelers
arrive. The jurisdiction of each station
includes air, maritime, and/or landborder ports of entry. Quarantine
Station staff work in partnership with
international, federal, state, and local
agencies and organizations to fulfill
their mission to reduce morbidity and
mortality among globally mobile
populations. This work is performed to
prevent the introduction, transmission,
and spread of communicable diseases
from foreign countries into the United
States or from one State or possession to
another State or possession. When an
illness suggestive of a communicable
disease is reported by conveyance
operators or port partners (e.g., Customs
and Border Protection), Quarantine
Officers respond to carry out an onsite
public health assessment and collect

reports of illness of each type, ILI and
others.
• For fall 2018, CDC is considering a
policy change related to requirements
for rabies vaccination documentation for
dogs coming from certain countries;
therefore, CDC is providing estimates of
burden and respondents related to
importation of dogs into the United
States.
• Revised estimates under 42 CFR
71.55, 42 CFR 71.32 Dead Bodies—
Death certificates.
• Revised estimate of the number of
requests for exemptions for importation
of African rodents.
Respondents for this information
collection request are any pilot in
command of an aircraft or maritime
vessel operator. With an ill person
meeting certain criteria, or death aboard;
any individual who is subject to federal
quarantine or isolation; any ill traveler
who is reported by the airlines, Customs
and Border Protection, or EMS to CDC
or the local public health authority that
meets the definition of ill person; and
any importer or filer who seeks to bring
certain animals, animal products, or
other CDC-regulated item into the
United States.
For most of these collections, there
are no costs to respondents other than
their time. Examinations of imported
animals is only required if the pet is ill
on arrival or if it has died during
transport. These exams are not routine.
Depending on the time of arrival, the
initial exam fee may be between $100
and $200. Rabies testing on a dog that
dies may be between $50 and $100. The
expected number of ill or dead dogs
arriving into the United States for which
CDC may require an examination is
estimated at less than 30 per year. CDC
is requesting a three-year approval.

data from the individual. This response
may occur jointly with port partners.
The collection of comprehensive,
pertinent public health information
during these responses enables
Quarantine Officers to make an accurate
public health assessment and identify
appropriate next steps. For this reason,
quarantine station staff need to
systematically interview ill travelers
and collect relevant health and
epidemiologic information.
CDC is making a number of changes
and adjustments to this information
collection. The changes are as follows:
• CDC is merging this information
collection with another, 0920–0821
Illness Response Forms: Airline,
Maritime, and Land/Border Crossing.
• CDC is disaggregating the
information collection 42 CFR 71.21(a)
report of illness or death from ships so
that the influenza like illness (ILI)
report, which is voluntary, is separate
from the required report of ill person or
death.
• CDC is removing the information
collection pertaining to Partner
Government Agency Message Sets,
because CDC will not collect
information using these tools.
• CDC is removing the acute
gastroenteritis reports from ships and
removal of medical logs information
collection from this information
collection request, because CDC’s Vessel
Sanitation Program will submit a
separate information collection request
for these tools.
CDC is requesting the following
adjustments
• As described above, CDC is
requesting a separation of the maritime
(ILI) and other maritime illness or death
reports. CDC is also requesting an
increase in the total number of maritime

ESTIMATED ANNUALIZED BURDEN HOURS
Regulatory provision or form name

Maritime Vessel Operator ......

42 CFR 71.21(a) report of illness or death from ships—Maritime
Conveyance Illness or Death Investigation Form sections 1–4.
42 CFR 71.21(a) report of illness or death from ships—Maritime
Conveyance Illness or Death Investigation Form section 5.
Cumulative Influenza/Influenza-Like Illness (ILI) ..........................
42 CFR 71.21(b) Death/Illness reports from aircrafts ..................
Airline Travel Illness or Death Investigation Form .......................
Land Travel Illness or Death Investigation Form .........................
42 CFR 71.33 Report by persons in isolation or surveillance .....

Maritime Vessel Operator ......

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Number of
respondents

Type of respondent

Maritime Vessel Operator ......
Pilot in command ...................
Traveler ..................................
Traveler ..................................
Isolated or Quarantined individuals.
Maritime Vessel Operator ......
Importer ..................................
Importer ..................................
Importer ..................................
Importer ..................................
Importer ..................................
Importer ..................................

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42 CFR 71.35 Report of death/illness during stay in port ...........
42 CFR 71.51(c)(1), (d)—Valid Rabies Vaccination Certificates
CDC Form 75.37 Notice To Owners And Importers Of Dogs:
Requirement for Dog Confinement.
42 CFR 71.51(c)(i), (ii), and (iii) exemption criteria for the importation of a dog without a rabies vaccination certificate.
42 CFR 71.51(c)(2), (d) Application For Permission To Import A
Dog Inadequately Against Rabies.
42 CFR 71.51(b)(3) Dogs/cats: Record of sickness or deaths ....
42 CFR 71.52(d) Turtle Importation Permits ................................

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Number of
responses per
respondent

Average
burden
per response
(in hours)

Total burden
hours

500

1

5/60

42

100

1

2/60

3

3,000
1,700
1,700
100
11

1
1
1
1
1

2/60
2/60
5/60
5/60
3/60

100
57
142
8
1

5
113,500
14

1
1
1

30/60
15/60
10/60

3
28,375
2

958,000

1

15/60

239,500

50

1

45/60

38

20
5

1
1

15/60
30/60

5
3

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Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
responses per
respondent

Average
burden
per response
(in hours)

Total burden
hours

Regulatory provision or form name

Importers ................................
Importer ..................................
Importer ..................................
Importer ..................................

42 CFR 71.55 Dead Bodies, 42 CFR 71.32—Death certificates
42 CFR 71.56 (a)(2) African Rodents—Request for exemption ..
42 CFR 71.56(a)(iii) Appeal .........................................................
42 CFR 71.32 Statements or documentation of non-infectiousness.

20
25
2
2,000

1
1
1
1

1
1
1
5/60

20
25
2
167

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

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

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

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

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

268,493

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. 2018–19381 Filed 9–6–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–18–18CI]

Agency Forms Undergoing Paperwork
Reduction Act Review

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Number of
respondents

Type of respondent

In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled ‘‘Evaluation of
TransLife Center (TLC): A LocallyDeveloped Combination Prevention
Intervention for Transgender Women at
High Risk of HIV Infection’’ 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 January
30, 2018 to obtain comments from the
public and affected agencies. CDC
received one (1) 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;

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(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 [email protected]. 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
Evaluation of TransLife Center (TLC):
A Locally-Developed Combination
Prevention Intervention for Transgender
Women at High Risk of HIV Infection—
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 24 months of
data collection entitled, ‘‘Evaluation of
TransLife Center (TLC): A LocallyDeveloped Combination Prevention
Intervention for Transgender Women at
High Risk for HIV Infection.’’ The
purpose of this study is to evaluate the
efficacy of TLC, which provides
combination (biomedical, behavioral
and social/structural) HIV prevention
and care services to adult transgender
women at high risk for HIV infection, in
a culturally specific and accessible
environment. The information collected

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through this study will be used to
evaluate whether the TLC intervention
is an effective HIV-prevention strategy
by assessing whether exposure to TLC
services results in improvements in
participants’ health and HIV prevention
behaviors. The trial will assess whether
intervention participants’ behaviors
significantly change from baseline to 4and 8-month follow-up periods.
This study will be carried out in
Chicago, Illinois, where the TLC
program is located. The study
population will include 150 HIVnegative adult transgender women
living in the Chicago metropolitan area.
Participants will be at least 18 years of
age; self-identify as transgender,
transsexual, women and/or female who
was assigned male sex at birth; and have
a self-reported history of sex with men
in the past four months. The study
population will also include 10 TLC
staff members. Staff members will be
adults, involved in the delivery of TLC
intervention services. Participation in
this study is voluntary.
We anticipate enrollment of a diverse
sample of transgender women
comprised mainly of racial/ethnic
minority participants under 35 years of
age, consistent with the current TLC
program and 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. TLC staff members will be
randomly selected to participate in the
evaluation.
A computer-assisted quantitative
assessment will be used to collect
information for this study, which will
be delivered at the time of study
enrollment and again at 4-month and 8month follow-ups. The assessment will
be used to measure changes in sexual
risk behavior including condom use and
pre-exposure prophylaxis (PrEP) care
engagement. Intervention mediators,
including gender affirmation, collective
self-esteem and social support, and
intervention satisfaction will also be

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