Agency Forms Undergoing Paperwork Reduction Act Review

Citation85 FR 86932
Record Number2020-28982
Published date31 December 2020
SectionNotices
CourtCenters For Disease Control And Prevention,Health And Human Services Department
86932
Federal Register / Vol. 85, No. 251 / Thursday, December 31, 2020 / Notices
5
See, e.g., Statement of Commissioner Maureen
K. Ohlhausen, In the Matter of Health Discovery
Corporation and FTC v. Avrom Boris Lasarow, et al.
(Feb. 2015), https://www.ftc.gov/public-statements/
2015/02/dissenting-statement-commissioner-
maureen-k-ohlhausen-matter-health; Statement of
Commissioner Joshua D. Wright, FTC v. Kevin
Wright; HCG Platinum, LLC; and Right Way
Nutrition, LLC (Dec. 2014), https://www.ftc.gov/
public-statements/2014/12/statement-
commissioner-joshua-d-wright-federal-trade-
commission-v-kevin; Statement of Commissioner
Joshua D. Wright, In the Matter of GeneLink, Inc.,
and foru International Corporation (January 2014),
https://www.ftc.gov/public-statements/2014/01/
statement-commissioner-joshua-d-wright-matter-
genelink-inc-foru; Statement of Commissioner
Maureen K. Ohlhausen Dissenting in Part and
Concurring in Part, In the Matter of GeneLink, Inc.
and foru International Corporation (January 2014),
https://www.ftc.gov/public-statements/2014/01/
statement-commissioner-maureen-k-ohlhausen-
dissenting-part-concurring-part; Dissenting
Statement of Commissioner Maureen K. Ohlhausen,
FTC v. Springtech 77376, et al. (July 2013), https://
www.ftc.gov/public-statements/2013/07/dissenting-
statement-commissioner-maureen-k-ohlhausen; see
also J. Howard Beales, III and Timothy J. Muris, In
Defense of the Pfizer Factors, George Mason Law &
Economics Research Paper No. 12–49 (May 2012),
available at: https://papers.ssrn.com/sol3/
papers.cfm?abstract_id=2087776.
6
See Statement of Commissioner Rohit Chopra
Regarding the Cannabidiol (CBD) Enforcement
Actions (Dec. 17, 2020).
information, may diminish incentives to
conduct research, and could chill
manufacturer incentives to introduce
new products to the market.
5
And I
agree with the observation of my
colleague Commissioner Chopra in his
statement that ‘‘[b]aseless claims give
patients false hope, improperly increase
or divert their medical spending, and
undermine ‘a competitor’s ability to
compete’ on honest attributes.’’
6
Although I support these cases, I hope
that the Commission’s actions here,
which challenge wholly unsubstantiated
disease claims, do not discourage
research into the potential legitimate
benefits of CBD and a wide array of
other products. In addition, going
forward, I urge the Commission to focus
our scarce resources on marketers that
make strong, express claims about
diseases and serious health issues with
little to no scientific support and engage
in deceptive practices that cause
substantial consumer injury.
[FR Doc. 2020–29003 Filed 12–30–20; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30 Day–21–1277]
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 The Childcare
Survey of Activity and Wellness (C–
SAW) Pilot Study 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 October
30, 2020 to obtain comments from the
public and affected agencies. CDC
received one public 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.
Comments and recommendations for the
proposed information collection should
be sent within 30 days of publication of
this notice to www.reginfo.gov/public/
do/PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. 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
The Childcare Survey of Activity and
Wellness (C–SAW) Pilot Study (OMB
Control No. 0920–1277, Exp. 12/31/
2020)—Revision—National Center for
Chronic Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and
Prevention (CDC) work to promote
optimal nutrition, physical activity, and
wellness in early care and education
(ECE) facilities for children 0–5 years of
age. Data collected from this pilot
survey will be used to understand the
current practices of ECE centers in a
representative sample in four states. The
survey will also be used to inform the
development of a potential national
surveillance system.
A sample of approximately 1,266 ECE
centers across four states will be
selected to participate in this one-time
data collection effort. However, it is
estimated that approximately 10% of
the original sample will be out of
business or otherwise ineligible yielding
an actual sample of 1,140 ECEs to be
recruited. Each center will receive a
recruitment letter introducing the
survey, and instructions for completing
the survey. It is anticipated that most
responses will be submitted through the
web. However, paper surveys will be
available upon request. It is also
anticipated that the response rate will
be approximately 55% based on a
review of recent surveys of childcare
centers conducted by the Federal
government. Thus, we anticipate the
number of completed surveys to be 627.
CDC requests approval for a two year
period with an estimated 513 total
Burden Hours. Participation in this
study is completely voluntary and there
are no costs to the respondent other
than their time.
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86933
Federal Register / Vol. 85, No. 251 / Thursday, December 31, 2020 / Notices
E
STIMATED
A
NNUALIZED
B
URDEN
H
OURS
Type of respondents Form name Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
ECE Director or Administrator ........................ Recruitment Letter .......................................... 1,140 1 5/60
ECE Director or Administrator ........................ Web/Mail Survey ............................................ 627 1 40/60
Jeffery M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–28982 Filed 12–30–20; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Requirement for Negative Pre-
Departure COVID–19 Test Result for All
Airline Passengers Arriving Into the
United States From the United
Kingdom
AGENCY
: Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION
: Notice of Agency Order.
SUMMARY
: The Centers for Disease
Control and Prevention (CDC), a
component of the U.S. Department of
Health and Human Services (HHS),
announces an Agency Order requiring
negative pre-departure COVID–19 test
results for all airline passengers arriving
into the United States from the United
Kingdom (UK). This Order is issued to
preserve human life; prevent the further
introduction, transmission, and spread
of the virus that causes COVID–19 into
the United States, including new virus
variants; preserve the health and safety
of airline crew members, passengers,
airport personnel, and communities;
and preserve hospital, healthcare, and
emergency response resources within
the United States.
DATES
: This Order was effective
December 27, 2020 at 7:01 p.m. EST
(12:01 a.m. December 28, 2020 GMT).
See
SUPPLEMENTARY INFORMATION
for the
conditions under which the Order will
expire.
FOR FURTHER INFORMATION CONTACT
:
Jennifer Buigut, Division of Global
Migration and Quarantine, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, MS H16–4, Atlanta,
GA 30329. Email: dgmqpolicyoffice@
cdc.gov.
SUPPLEMENTARY INFORMATION
: On
December 14, 2020, Public Health
England announced that a new variant
of SARS-CoV–2 had been identified
across the southeast of England (i.e.,
Kent and the surrounding areas). While
it is known and expected that viruses
change through mutation leading to the
emergence of new variants, preliminary
analysis in the UK suggests that this
SARS–CoV–2 variant may be more
transmissible than previously
circulating variants. Pre-departure
testing may detect travelers infected
with SARS–CoV–2 before they initiate
their travel and may reduce the risk of
transmission. Therefore, urgent efforts
are needed to mitigate the potential
spread of this new virus variant into the
United States.
This Order establishes requirements
for (1) airlines arriving into the United
States from the UK; and (2) passengers
departing the United Kingdom with a
final destination in the United States.
A copy of the Order and Attachment
A are provided below and a copy of the
signed order can be found at https://
www.cdc.gov/quarantine/testing-
requirement-for-arriving-UK-air-
travelers.html.
Centers for Disease Control and
Prevention Department of Health and
Human Services
Order Under Section 361 of the Public
Health Service Act (42 U.S.C. 264) and
42 Code of Federal Regulations 71.20 &
71.31(b)
Requirement for Negative Pre–
Departure Covid–19 Test Result for All
Airline Passengers Arriving Into the
United States From the United Kingdom
(UK)
Summary
Pursuant to 42 CFR 71.20 and as set
forth in greater detail below, this Notice
and Order prohibit the introduction into
the United States of any airline
passenger departing from the UK unless
the passenger has a negative pre-
departure test result for COVID–19. The
test must be a viral test that was
conducted on a specimen collected
during the 3 calendar days preceding
the flight’s departure (Qualifying Test).
Passengers must retain written or
electronic documentation reflecting the
negative Qualifying Test result
presented to the airline and produce
such results upon request to any U.S.
government official or a cooperating
state or local public health authority.
Pursuant to 42 CFR 71.31(b) and as set
forth in greater detail below, this Notice
and Order constitutes a controlled free
pratique to any airline with an aircraft
arriving into the United States from the
UK. Pursuant to the controlled free
pratique, the airline must comply with
the following conditions in order to
receive permission for the aircraft to
enter and disembark passengers in the
United States:
Airline must verify that every
passenger—2 years of age or older—
onboard the flight has attested to having
received a negative Qualifying Test
result.
Airline must confirm that every
passenger onboard the aircraft has
documentation reflecting a negative
Qualifying Test result.
Statement of Intent
This Order shall be interpreted and
implemented in a manner as to achieve
the following paramount objectives:
Preservation of human life;
Preventing the further introduction,
transmission, and spread of the virus
that causes COVID–19 into the United
States, including new virus variants;
Preserving the health and safety of
airline crew members, passengers,
airport personnel, and communities;
and
Preserving hospital, healthcare, and
emergency response resources within
the United States.
Definitions
Airline shall have the same definition
as under 42 CFR 71.1(b).
Attest/Attestation means having
completed the attestation in Attachment
A. Such attestation may be completed in
written or electronic form. The
attestation is a statement, writing, entry,
or other representation under 18 U.S.C.
1001.
Confirm that every passenger onboard
the aircraft has documentation
reflecting a negative Qualifying Test
result means confirmation that:
(1) The personal identifiers (e.g.,
name and date of birth) on the
Qualifying Test result match the
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