Proposed Data Collection Submitted for Public Comment and Recommendations, 12615-12616 [2019-06312]
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Federal Register / Vol. 84, No. 63 / Tuesday, April 2, 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. 2019–06311 Filed 4–1–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–19–19VJ; Docket No. CDC–2019–
0013]
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 The Childcare Survey of Activity
and Wellness (C-SAW) Pilot Study. The
pilot study will determine the current
practices and policies of early care and
education (ECE) providers in four states
around nutrition, physical activity, and
wellness and will inform the
development of a potential national
surveillance system.
DATES: CDC must receive written
comments on or before June 3, 2019.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2019–
0013 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.
amozie on DSK9F9SC42PROD with NOTICES
SUMMARY:
Please note: Submit all comments through
the Federal eRulemaking portal
(regulations.gov) or by U.S. mail to the
address listed above.
VerDate Sep<11>2014
18:45 Apr 01, 2019
Jkt 247001
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.
FOR FURTHER INFORMATION CONTACT:
Proposed Project
The Childcare Survey of Activity and
Wellness (C–SAW) Pilot Study—New—
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) works to promote
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Fmt 4703
Sfmt 4703
12615
optimal nutrition, physical activity, and
wellness in early care and education
(ECE) facilities for children 0–5 years of
age. Consistent with this mission, and
with clear evidence that ECE facilities
can impact the habits and preferences of
young children, this survey is necessary
to better understand ECE center
practices related to nutrition, physical
activity, and wellness. These critical
data are used to effectively inform state
and national programs.
Data collected from this pilot survey
will be used to understand the current
practices of ECE centers in a
representative sample in four states.
This initial C–SAW will establish
baseline measures of the prevalence of
specific practices related to nutrition,
physical activity, and wellness in a
standard way across states. This
baseline will also allow CDC and state
partners to better understand ECE center
needs and provide opportunities for
collaboration and areas for improvement
at the state and national levels. Second,
the survey will be used to inform the
development of a potential national
surveillance system enabling states and
CDC to track changes over time and
obtain data to guide the planning,
implementation, and evaluation of
national and state obesity prevention
efforts.
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, explaining its objectives and the
importance of their participation, 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. Approximately two weeks after
the initial recruitment letter is mailed,
all sampled centers will receive a
reminder postcard. Approximately four
weeks after the initial recruitment letter
is mailed, nonrespondents will be sent
another letter along with a hardcopy of
the questionnaire. It is also anticipated
that the response rate will be
approximately 55% based on a review
of recent surveys of child care centers
conducted by the Federal government.
Thus, we anticipate the number of
completed surveys to be 627. CDC
requests approval for an estimated 409
Burden Hours. Participation in this
study is completely voluntary and there
are no costs to the respondent other
than their time.
E:\FR\FM\02APN1.SGM
02APN1
12616
Federal Register / Vol. 84, No. 63 / Tuesday, April 2, 2019 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)
Total burden
(in hours)
Form name
ECE Director or Administrator ..........
ECE Director or Administrator ..........
Recruitment Letter ............................
Web/Mail Survey ..............................
1,140
627
1
1
5/60
30/60
95
314
Total ...........................................
...........................................................
........................
........................
........................
409
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–06312 Filed 4–1–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0803]
Advisory Committee; Technical
Electronic Product Radiation Safety
Standards Committee; Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Technical Electronic
Product Radiation Safety Standards
Committee (Committee) by the
Commissioner of Food and Drugs (the
Commissioner). The Commissioner has
determined that it is in the public
interest to renew the Committee for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until December 24, 2020.
DATES: Authority for the Technical
Electronic Product Radiation Safety
Standards Committee would have
expired on December 24, 2018, unless
the Commissioner formally determined
that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Patricio Garcia, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G610, Silver Spring,
MD 20993–0002, 301–796–6875,
Patricio.Garcia@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of the
Committee. The Committee is a nondiscretionary Federal advisory
SUMMARY:
amozie on DSK9F9SC42PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
Type of respondents
VerDate Sep<11>2014
18:45 Apr 01, 2019
Jkt 247001
committee established to provide advice
and consultation to the Commissioner.
The Commissioner of Food and Drugs is
charged with the administration of the
Radiation Control for Health and Safety
Act of 1968. This act creates the
Committee and requires the
Commissioner to consult with the
Committee before prescribing standards
for radiation emissions from electronic
products. This Committee provides
advice and consultation to the
Commissioner of Food and Drugs on the
technical feasibility, reasonableness,
and practicability of performance
standards for electronic products to
control the emission of radiation from
such products and may recommend
electronic product radiation safety
standards to the Commissioner for
consideration.
The Committee shall consist of a core
of 15 voting members, including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of science
or engineering applicable to electronic
product radiation safety. Members will
be invited to serve for overlapping terms
of up to 4 years. Terms of more than 2
years are contingent upon the renewal
of the Committee by appropriate action
prior to its expiration. The core of
voting members will include five
members selected from governmental
agencies, including State and Federal
Governments, five members from the
affected industries, and five members
from the general public, of which at
least one shall be a representative of
organized labor. A quorum shall consist
of 10 members, of which at least 3 shall
be from the general public, 3 from the
government agencies, and 3 from the
affected industries.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/RadiationEmittingProducts/TechnicalElectronic
ProductRadiationSafetyStandards
Committee/default.htm or by contacting
the Designated Federal Officer (see FOR
FURTHER INFORMATION CONTACT). In light
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Fmt 4703
Sfmt 4703
of the fact that no change has been made
to the committee name or description of
duties, no amendment will be made to
21 CFR 14.100.
This document is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please visit us at https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: March 27, 2019.
Lowell J. Schiller,
Commissioner of Food and Drugs.
[FR Doc. 2019–06360 Filed 4–1–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–P–2754]
Determination That ONFI (Clobazam)
Tablets, 5 Milligrams, Was Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that ONFI (clobazam)
tablets, 5 milligrams (mg), was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) that refer to the
drug product, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Darren Eicken, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave. Bldg. 51, Rm. 6206,
Silver Spring, MD 20993–0002, 240–
402–0978.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
SUMMARY:
E:\FR\FM\02APN1.SGM
02APN1
]]>Agencies
[Federal Register Volume 84, Number 63 (Tuesday, April 2, 2019)]
[Notices]
[Pages 12615-12616]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06312]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-19-19VJ; Docket No. CDC-2019-0013]
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 project titled The Childcare Survey of Activity
and Wellness (C-SAW) Pilot Study. The pilot study will determine the
current practices and policies of early care and education (ECE)
providers in four states around nutrition, physical activity, and
wellness and will inform the development of a potential national
surveillance system.
DATES: CDC must receive written comments on or before June 3, 2019.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2019-
0013 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:
[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
The Childcare Survey of Activity and Wellness (C-SAW) Pilot Study--
New--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) works to
promote optimal nutrition, physical activity, and wellness in early
care and education (ECE) facilities for children 0-5 years of age.
Consistent with this mission, and with clear evidence that ECE
facilities can impact the habits and preferences of young children,
this survey is necessary to better understand ECE center practices
related to nutrition, physical activity, and wellness. These critical
data are used to effectively inform state and national programs.
Data collected from this pilot survey will be used to understand
the current practices of ECE centers in a representative sample in four
states. This initial C-SAW will establish baseline measures of the
prevalence of specific practices related to nutrition, physical
activity, and wellness in a standard way across states. This baseline
will also allow CDC and state partners to better understand ECE center
needs and provide opportunities for collaboration and areas for
improvement at the state and national levels. Second, the survey will
be used to inform the development of a potential national surveillance
system enabling states and CDC to track changes over time and obtain
data to guide the planning, implementation, and evaluation of national
and state obesity prevention efforts.
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, explaining its objectives
and the importance of their participation, 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. Approximately two weeks after the initial recruitment
letter is mailed, all sampled centers will receive a reminder postcard.
Approximately four weeks after the initial recruitment letter is
mailed, nonrespondents will be sent another letter along with a
hardcopy of the questionnaire. It is also anticipated that the response
rate will be approximately 55% based on a review of recent surveys of
child care centers conducted by the Federal government. Thus, we
anticipate the number of completed surveys to be 627. CDC requests
approval for an estimated 409 Burden Hours. Participation in this study
is completely voluntary and there are no costs to the respondent other
than their time.
[[Page 12616]]
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
----------------------------------------------------------------------------------------------------------------
ECE Director or Administrator. Recruitment 1,140 1 5/60 95
Letter.
ECE Director or Administrator. Web/Mail Survey. 627 1 30/60 314
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 409
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2019-06312 Filed 4-1-19; 8:45 am]
BILLING CODE 4163-18-P
